Synopsis, Dissertation and Research For PG Students

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Synopsis, Dissertation and

Research to PG Students
Second Edition

GN Prabhakara MD
Professor and Head
Department of Community Medicine
SDM Medical College
Dharwad, Karnataka, India

The Health Sciences Publisher


New Delhi | London | Philadelphia | Panama

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Key for Your Success in
Synopsis, Dissertation and Research
Always use your own words throughout write-up
Always use your own sentences throughout write-up
Always use your own ideas throughout write-up
Always use your own outlines throughout write-up
Avoid copy and paste
Avoid any reproduction
Avoid some body’s expression

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Synopsis, Dissertation and Research to PG Students


First Edition : 2004
Second Edition : 2016

ISBN: 978-93-5250-158-8

Printed at

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Dedicated to
The Great Teacher
The Great Missile Man
Former President of India
Bharat Ratna Dr APJ Abdul Kalam

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Preface to the Second Edition

It gives me immense pleasure to write the preface to the Second Edition


with a new face Synopsis, Dissertation and Research to PG Students brought
out by our beloved M/s Jaypee Brothers Medical Publishers (P) Ltd,
New Delhi, India. Thousands of postgraduates from different courses
and disciplines from various universities, who are seeking guidance
regarding their dissertation/thesis work with respect to the preparation
of synopsis, methodology, designing research and final presentation,
are responsible for the outcome of the book.
An attempt has also been made to provide simple and systematic
guidance through this on postgraduate course, on university time-table,
on medical ethics that are relevant and prevention of hospital-acquired
infection.
Rajiv Gandhi University of Health Sciences (RGUHS), Bengaluru,
Karnataka, India, gave me a platform to prepare library reference
record, plan for dissertation work, proforma for synopsis, postgraduate
evaluation sheet, guidelines for writing references, and they are added
in the appendices for references.
Synopsis, Dissertation and Research are updated and elaborated
for the use of all postgraduates in University of Health Sciences, viz.
Medical, Dental, Pharmacy, Nursing, Ayurveda, Homeopathy, Hospital
Administration, and Speech and Hearing.
I hope that the book will serve present requirement of any
postgraduates and teachers in their endeavors.

GN Prabhakara

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Preface to the First Edition

Thousands of postgraduates from different courses and different


disciplines from various universities, who have been consulting me for
guidance regarding proforma, methodology, dissertation and thesis
work are responsible for the outcome of this book.
An attempt is made to provide simple and systematic guidance
through this text.
I hope that the book will serve as a guideline for postgraduates and
even teachers in their endeavors.

GN Prabhakara

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Acknowledgments

Guidance, corrections and appropriations, and for thorough help of my


life-partner Mrs Malathi Prabhakara, Ex-Scientist, Technology Transfer,
Industrial Development and Consultancy Services, Central Food
Technological Research Institute (CFTRI) and Council of Scientific and
Industrial Research (CSIR) is highly acknowledged.
Source of inspiration of my son Dr MP Bharat Associate Professor
and Head, Department of Radiodiagnosis, Shivamogga Institute of
Medical Sciences (SIMS); Consultant Radiologist (Shivamogga); and my
Daughter-in-Law, Dr Pooja Bharat, Assistant Professor (Anesthesia),
SIMS, Shivamogga, Karnataka, India, is acknowledged.
I acknowledge the respect and regard bestowed upon me by
postgraduate students of medical, dental, pharmacy, nursing, hospital
administration and management, homeopathy, speech and hearing,
and Ayurveda during the period 1972–2014, who inspired me to bring
out my experience in the present form.
I thank the following professional colleagues who gave their valuable
opinions:
1. S Kantha
Ex-Vice Chancellor
Rajiv Gandhi University of Health Sciences (RGUHS)
Bengaluru, Karnataka, India
2. SB Kulkarni
Ex-Principal
Karnataka Institute of Medical Sciences
Hubballi, Karnataka, India
3. AT Kulkarni
Ex-Principal
Maharashtra Institute of Medical Education and Research
Pune, Maharashtra, India
4. A Venugopala Sharma
Ex-Professor and Head
Department of Preventive and Social Medicine (PSM)
Tirupati Medical College
Tirupati, Andhra Pradesh, India

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xii Synopsis, Dissertation and Research to PG Students

5. Sunanda Kulkarni
Ex-Professor
Department of Obstetrics and Gynecology
Bangalore Medical College
Bengaluru, Karnataka, India
6. M Danabalan
Ex-Director and Professor
Department of Preventive and Social Medicine (PSM)
Jawaharlal Institute of Postgraduate Medical Education
and Research (JIPMER)
Puducherry, India
7. MK Sudarshan
Principal and Professor
Department of Community Medicine
Kempegowda Institute of Medical Sciences (KIMS)
Bengaluru, Karnataka, India
I hereby acknowledge the efforts of M/s Jaypee Brothers Medical
Publishers (P) Ltd, New Delhi, India, in giving a good shape to my
modest work with my heartfelt thanks.

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Contents

1. Introduction 1
• Felt Need 1
• Why Require Introductory Course?  2
• What is Expected of a Postgraduate? 2

2. Routine for a New Postgraduate 4


• Departmental Routine 4
• Institutional Routine 4
• Interdepartmental Routine 5
• Journal Club 5
• Subject Seminar 6
• Pedagogy 8
• Lesson Plan 10

3. Time Table for Three-Year Postgraduate Course 12


• Master Plan of the Course 12
• Yearwise General Course 12
• Yearwise Academic Course 13
• Yearwise Dissertation/Research Work 14
• Hospital Postings, Field Visits 14

4. Medical Ethics Involved in Postgraduate Work 16


• Medical Ethics  16
• Perspective of Medical Ethics 17
• Major Principles of Medical Bioethics 20
• Major Rules 21
• Practice of Medical and Bioethics 23
• Ethical Review Committee 24
• Laboratory and Clinical Trials 26
• Human Experimentation  29
• Ethical Problems in AIDS, Children and Mentally Ill  32
• Newer Areas of Ethical Interest  33
• Computer Ethics  34
• e-Research  34

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xiv Synopsis, Dissertation and Research to PG Students

• Ethical Issue with Alternative Medicine  34


• Medical Ethics and COPRA  35

5. Designing Research 38
• Specific Objectives 39
• Need of Design in Research/Project/Thesis/
Dissertation 40
• Drafting of Outline 40
• Nature of Topic to be Selected 41
• Steps in Designing 42
• Descriptive Study  44
• Case Control Study 46
• Cohort Study 47
• Clinical Trial 49
• Blinding 51
• Other Aspects of Designing 51
• College Level Activity in Study Design 52
• Minimizing errors and Bias 52

6. Preparation of Synopsis of Dissertation/Research 53


• Basic Information 54
• Title of the Topic 54
• Need of the Study 54
• Objective of the Study 55
• Review of Literature 55
• Material and Methods 56
• List of References 56
• Guide and Co-guide 56

7. Know-how on Actual Dissertation/Research 58


• Content 59
• Title 59
• Introduction 59
• Review of Literature 60
• Body 60
• Reference  61

8. Biostatistics for the Dissertation/Research 64


• Data Presentation 74
• Averages 80

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Contents xv

• Measures of Variability 84
• Sample Size 87
• Significant Test (Tests of Significance) 92
• Correlation 100
• Workout the Following Problems 103

9. Prevention of Hospital Acquired Infection 109


• High-risk Procedures 109
• Disinfection Procedure 111
• Discard and Disposal Hospital Waste 112
• Universal Precaution 113
• HIV/AIDS Control and Prevention 113
• Protection against Severe Acute Respiratory
Syndrome  115

10. Computer Technology in PG Dissertation Work 116


• Parts of Computer 116
• Software for Data Analysis 117
• Network/Internet 118
• Operating system 119

11. Biostatistical Tests for Dissertation


(Learning by Doing)  120
• S
 tandard Error of the Difference between
Two Means 120
• Standard Error of the Difference between
Two Proportion  122
• Chi-square Test 124
• Student t-Test 126
• Z-Test 134
• Pearson Correlation (r) 136
• Spearman Rank Correlation 139

Appendices 141
• Appendix I: Lesson Plan 141
• Appendix II: Library Reference Record
(Annotated Bibliography) 143
• Appendix III: Plan for Dissertation Work
(From the Date of Admission) 144
• Appendix IV: The Hippocratic Oath 145

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xvi Synopsis, Dissertation and Research to PG Students

• Appendix V: Declaration of Helsinki 146


• Appendix VI: Proforma for Synopsis of Dissertation
Submission within 6 Months after Admission to the
Course 151
• Appendix VII
Model Synopsis–1: Rajiv Gandhi University of Health
Sciences (RGUHS), Bengaluru, Karnataka  155
 Model Synopsis–2: Rajiv Gandhi University of Health
Sciences (RGUHS), Bengaluru, Karnataka  159
Model Synopsis–3: Rajiv Gandhi University of Health
Sciences (RGUHS), Bengaluru, Karnataka  163
• Appendix VIII: PG Dissertation Evaluation Sheet 169
• Appendix IX: Model of ‘Review of Literature’ 171
• Appendix X: Guidelines for Writing References 173
• Appendix XI: Permissible Error and Confidence Interval
for Sample Size Determination 176
• Appendix XII: Cumulative Distribution of Chi-Square 177
• Appendix XIII: Short Table of Areas of Normal Curve 178
• Appendix XIV: The Distribution of ‘t’ (Two Tailed Tests) 179
• Appendix XV: First Aid: HIV/AIDS 180
• Appendix XVI: Hospital Guidelines for Severe Acute
Respiratory Syndrome Control 181
• Appendix XVII: Format for Ethical Committee Meeting
Submission by Postgraduates 182

Index 183

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1
CHAPTER
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Introduction O
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Postgraduate course is a platform for learning, understanding and
interacting with surrogates, with peers and with subordinates for an
effective gain in knowledge in his / her specialty. The steps in the course
give arena for an effective preplanning followed by planning for research
through study, survey and surveillance.
During the entire postgraduate course of three years, day- to - day
activity recording ( Diary) help the postgraduate to accomplish a course
of action in the event of anticipated duty, academic achievement,
knowledge and skills.
Acquaintance of department routine include the steps in prevention
of hospital acquired infections, ethical and bioethical issues in relation
to patient management, designing a research and conducting a study for
dissertation, basic application of statistics in interpretation of collected
data. O
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FELT NEED
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The beginning of the course need refining by gradual exposure to E
postgraduate training. If a concept of introductory note on postgraduate
tn
course is available, acquiring knowledge becomes simple and the
balance of time can be diverted to the area of study.
Each postgraduate should:
• Acquire routine formal procedure in his department / hospital
• Know, how library reference to be made
• Know, how samples / specimens are collected
2 Synopsis, Dissertation and Research to PG Students

zz Know, how collected sample/specimen is transported for laboratory


examination
zz Acquaint with universal precautions to be taken for HIV/AIDS
zz Learn research methods required for dissertation
zz Learn basic statistics for data analysis
zz Know existing medical and bioethical code of conduct
zz Help the Institution in carrying out National Health Programme.

WHY REQUIRE INTRODUCTORY COURSE?


Introductory course is required to tune up a postgraduate in the following
areas:
zz Initially he is not well-versed in participating in journal club, subject

seminar and other academic activities


zz Art of taking undergraduate small group classes need learning

zz He will not be in a position to plan out a schedule to complete

dissertation work in time


zz Professional ethics would not have been known

zz Within six months of admission, preparing the synopsis of his

dissertation for submitting to university may become difficult


zz When the synopsis is approved, how to go about the study with study

design seems to be a herculean task


zz Without guidance, postgraduate feel difficulty in data analysis and

application of significant tests


zz Much more so he should protect himself from hospital acquired

infections, since he is a risk group as health care worker.

WHAT IS EXPECTED OF A POSTGRADUATE?


Postgraduate student when admitted need to attend graded responsibility
in:
zz Diagnosis and treatment of cases

zz Participation in seminar

zz Participation in group discussion

zz Attend hospital ward rounds

zz Skills in case demonstration

zz Active participation in case clinics

zz Participate in journal club

Ch-01.indd 2 09-10-2015 16:49:01


Introduction 3

zz Attend the scheduled clinical meetings


zz Attend the clinicopathological conferences
zz Involve in undergraduate teaching in small batches.
Postgraduate training include:
zz Imparting knowledge through theory class, research work, and
academic activities
zz Imparting skills through laboratory work, experiments and case

clinics.
Following item analysis and understanding is a must for a postgraduate
in Health Science course:
zz Development of competence in his field

zz Keeping abreast of recent development

zz Learn to develop research methods

zz Learn to interpret data and decision

zz Maintenance of professional ethics

zz Recognition of our society need.

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CHAPTER
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Routine for a New
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DEPARTMENTAL ROUTINE
Outpatient duties
Ward duties
Undergraduate tutorials
When assigned , clinical teaching to undergraduates in small batch
Grand round discussion with faculty
OT major-duty
OT minor-duty
Night duties
Joining all clinics including undergraduate
Attending to routine investigation of patients
Collection of sample /specimen
Transportation of a sample / specimen for investigation
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Attending to hospital disinfection procedure. LU

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INSTITUTIONAL ROUTINE CD
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• Attending and participation in health check- up camps
• Cancer screening programs tn

• Blood donation camps


• Attending to workshop and symposia and participation in national
and state level conferences
• Participation in extracurricular and co - curricular activities
( representing the college)
• Casualty duties
• Health awareness programs in the community
Routine for a New Postgraduate 5

zz Attending to National Health Programmes when posted from the


college.

INTERDEPARTMENTAL ROUTINE
zz Clinical meetings
zz Clinicopathological conference
zz Integrated teaching activities
zz Attending to other departmental postings, when posted, as per
Medical Council of India (MCI) stipulation
zz Referral activities
zz Study visits.

JOURNAL CLUB
Journal club is an academic exposure of a postgraduate student to recent
area of research, study, survey and/or critical review. Journal need not
mean only periodical publications of an organization. It can include
relevant text, special reports, technical reports, health papers, bulletin of
an association and organization. This can also include science journal,
any associated journals and recognized unpublished data.
Postgraduate is expected to study the article, make required
additional library references, make required cross references, formulate
a mode of presentation and present it in a scheduled journal club of his
department.
In a journal club presentation, following areas are focused:
zz The article should be research oriented, with feasible application in
health sciences
zz It should contain objectives, need and research design in the study

zz Should have problem identified

zz Should meet the standard description of literature review

zz It should project ethical issues pertaining to medical ethics and

bioethics
zz It is better, if the material belong to their area of discipline

zz Public health problems or community health problems are always

welcome.
Common types of article we come across are:
zz Review
zz Epidemiological survey

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6 Synopsis, Dissertation and Research to PG Students

zz Prospective study
zz Retrospective study
zz Experimental study
zz Annuls of academic society
zz Case study.
Requisite at journal club:
zz Prepare aids for the presentation

zz Try to project the articles as though it is done by you

zz Prepare critical review of the following:

—— Title

—— Sample size

—— Selection of case/sampling technique

—— Data collection procedure

—— Type of the study

—— Duration and period of study

zz Add a note on presentation pattern

zz Critically review:

—— How analyzed

—— How discussed

zz Try to answer whether objective of the study is fulfilled

zz Know, how reference are made:

—— Vancouver method

—— Harvard method

zz Try for comparison with similar such study.

During your presentation of the article in the journal club, very common
question asked by your faculty are:
zz Question related to the basics of the topic (Thematic)

zz Applied relevance of the article

zz Techniques used and their description as to how they are done in

laboratory
zz How it can be improved.

SUBJECT SEMINAR
It is an emphasized topic, selected for an in-depth study by a postgraduate
student and is presented in Intradepartmental discussion forum.
Subject seminar is always through open-to-open viable discussion and
is utilized for practical application in the given specialty.

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Routine for a New Postgraduate 7

Usually major area of interest in the discipline, common health


problem faced in day-to-day practice, recently emerged health problem,
area where uncertainty prevail, a concept of subject which is subjected
to frequent change, etc. are the areas that are selected for the topic to be
presented in subject seminar.
Objectives of subject seminar:
zz To make a postgraduate to do in-depth study and in-depth analysis
of a given situation
zz Extensive historical aspect is encased

zz Past, present and future of a theme or of a subject give laudable

sound concept which is applicable in clinical practice


zz An exercise for library reference

zz Subject seminar include all aspect of a theme/subject, inclusive of

recent advances.
Topic of priority:
zz Regional health problem
zz National health programme

zz Endemic diseases

zz Commonly encountered health problem in their discipline, which is

encountered as challenging problem in day-to-day practice


zz Problem which need multidisciplinary approach

zz A syndrome

zz Research carried out in the institute/college

zz Selected area of research, set by senior faculty of the department or

HOD.
Learning objective to postgraduate:
zz Get to know, how to do bibliography
zz Get to know, how library reference is made

zz Get to know the methods of material collection and putting in an

order
zz Schematic way of learning is available

zz Schematic way of presentation is learnt.

Other requisite:
zz Always make use of audiovisual aid in the presentation. This helps
you for your flow of thought.
zz Always get the subject seminar documented and put in order and

copies of which are given to all postgraduates and all faculty.

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8 Synopsis, Dissertation and Research to PG Students

PEDAGOGY
Each postgraduate after graduation with PG degree, whether specialist or
a teacher, become obligatory to impart his skill and knowledge to other
youngsters during his service period. This makes each postgraduate to
learn the basics of art and science of teaching technology.
In Greek teaching of nontutorial where boys and girls were allowed
in the learning process, there appeared a private element called
PEDAGOGUE (servant leading the child to school) which lead to present
nomenclature of PEDAGOGY , the Art and Science of Teaching.
As PG one has to develop the art and science of teaching.
If you prepare and take a lesson for teaching, you would have
undergone thorough study, reference and expertise. But it also needs
educational technology to be adopted for a better impact.
Pedagogy deals with principles and practice of medical education
components (Fig. 2.1).

Fig. 2.1  The educational spiral

Suppose you learn the art of taking a clinics to a small batch, the
learner (your junior or a UG) in turn learns certain skills and hence,

Ch-02.indd 8 09-10-2015 16:50:07


Routine for a New Postgraduate 9

could perform better in examination, test and management; which


they were unable to do earlier—is a MATTER emerged from the utility
of pedagogy.
In pedagogy, there are three areas called domain.
They are:
1. Area of knowledge (Cognitive domain) e.g. Define hypertension
(how to define by verbal expression and demonstration means is by
pedagogy. Here your technique is an art under teaching technology
2. Area of skill (Psychomotor domain) e.g. Demonstration of basic
cardiopulmonary resuscitation (CPR)
3. Area of attitude (Affective domain) e.g. You demonstrate anxiety of
patient and spend little time to overcome it.
Teaching technology in medical education are:
zz Lecture
zz Practical teaching

zz Clinical teaching

zz Tutorial

zz Group discussion

zz Buzz session

zz Syndicate session

zz Learning by doing

zz Micro-teaching

zz Adult teaching technology like workshop, continuing medical

education (CME), seminar, symposia and conference.


Further your exposure in early phase of learning, and participation is a
must to add learning experience through:
zz Panel discussion

zz Symposia

zz Seminar

zz Institute

zz Workshop

zz Convention

zz Conference.

In Pedagogy, your planning and management is needed for:


zz Lesson plan (detailed below and also see appendix).
zz Plan for a lesson for:

—— Material

—— Time

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10 Synopsis, Dissertation and Research to PG Students

—— Method of presentation
—— Aid used
zz Curriculum plan:
—— Little detail of aspect of your lesson constitute curriculum for a

lesson you are taking.


zz Resource management:
—— Display

—— Media

—— Material.

LESSON PLAN
In a simpler language it refers to the notes, document or content matter
of teaching lesson.
As PG one has to develop the quality of maintaining lesson plan
For carrying out lesson through different teaching methods one has
to think, write down the steps, sketch the events, outline the content and
stipulate the course, which constitute a PLAN FOR LESSON .
It is a skilled professional activity by a learned to a learner in a
classroom, ward, OPD, IPD, OT etc., which will give an account of
educational objectives in a given duration, through some specific means
called LESSON. This can be a unit of educational experience by you.
Approaches in lesson plan:
zz Regional college of Education Mysore Approach (System Approach)

zz Presentation Approach (Approach of Herbart)

zz Unit Approach (Approach of Morrison)

zz Approach of Evaluation (Approach of Bloom).

Criteria to call a lesson good:


zz No detailing

zz No fragmentation

zz Flexible

zz Source known

zz Relevant

zz Clear

zz Practiceable.

Elements of lesson plan:


zz Subject, topic, class and duration of the class

zz Objectives, general

Ch-02.indd 10 09-10-2015 16:50:08


Routine for a New Postgraduate 11

zz Specific learning objectives


zz Time schedule, contents, methods, media
zz Evaluation
zz Assignment exercise.
Two important points in lesson plan:
zz If the lesson plan is for theory then it is for acquiring knowledge by
the learner.
zz If the lesson plan is for practical or case clinics, demonstration, then

it is for acquiring skills by the learner.


Actual preparation of lesson plan: (Appendix 1)
zz Do library reference, read texts, journals and make notes
zz Have break up of topic, sub topics for class

zz Demarcate clear objectives, general and specific

zz Time allocation is done

zz Specify media and method of presentation

zz In between have interaction, at least once in 10 minutes

zz Continue subsequent class from the assignment given in previous

class.
Additional care in lesson plan:
zz Meet any unexpected reaction in the class
zz Not to restrict yourself the lesson plan, but go beyond, if required

zz Revise your lesson, each time

zz Accept comments.

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CHAPTER Time Table for Three-
i
Year Postgraduate
j
Course O
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MASTER PLAN OF THE COURSE


Postgraduate course is made useful for the ensuing university scheme
of examinations.
It consists of:
Dissertation: Every candidate should carry out and submit a dissertation
as per respective council stipulation. Acceptance of dissertation is a
prerequisite for examination appearance eligibility.
Theory: All three years day-to -day teachings and time scheduled text-
book reading should fulfill the knowledge for the written examination.
Practicals and / or Clinicals: Day- to -day practicals and clinicals need
repeat study and review. This will help a postgraduate to take practical
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examination in a competent manner. LU


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Viva : All the three years interaction with peers, surrogates and
subordinates make postgraduate fit enough to tackle the viva examination. CD
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Review of senior PG work : This helps a postgraduate to defend his
dissertation, which is a part of Grand Viva. tn

YEARWISE GENERAL COURSE

First Year
• All subjects studied in undergraduate course for example in
medical course, Anatomy, Physiology, Biochemistry, Pharmacology,
Time Table for Three-Year Postgraduate Course 13

Pathology, Microbiology, Forensic Medicine, Community medicine,


Medicine, Surgery, Obstetrics and Gynecology (OBG), and
Pediatrics; should be reviewed in the textbooks which a candidate
has studied in his UG examination time.
zz Basic science in relation to his subject is to be reviewed.
zz Observe and learn departmental routines.
zz Learn investigative procedures.
zz Observe journal club, subject seminar and UG teaching programs,
which you have to undertake in future.

Second Year
zz Standard textbook reading for the area of his subject should be
completed by second year of his course.
zz Practical and clinical orientation books should be given a reading.
zz Participation in journal club, subject seminar, UG teaching,
clinicopathological conference and departmental clinical meetings.

Third Year
zz By now postgraduate must have completed his dissertation and is
expected to undertake fully geared library references, which will be
for:
—— His dissertation defending

—— His knowledge for written examination.

zz Active participation in journal club, subject seminar, UG teaching,


clinicopathological (CPC) and clinical meetings.

YEARWISE ACADEMIC COURSE


First Year
Try to learn to make:
zz Library references.
zz Annotated bibliography (Appendix-2).

Second Year
Plan out for a short scientific paper presentation in a conference, from
your dissertation work done.

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14 Synopsis, Dissertation and Research to PG Students

Third Year
Plan out for sending a paper for journal publication. Participate in
journal club, subject seminar, clinical meeting, CPC, and UG training
programs.

YEARWISE DISSERTATION/RESEARCH WORK:


(APPENDIX 3)
First 6 Months
zz Problem identification
zz Review of literature
zz Preparation of proforma/structured questionnaire
zz Doing a pilot study
zz Taking ethical clearance from your college level ethical committee
zz Submission of synopsis of dissertation to the university.

7th Month to 18 Month


zz Dissertation work in hospital/field work in community
zz Collection of data in the prepared proforma.

19th Month to 24 Month


zz Tabulation of the data collected for dissertation
zz Data analysis
zz Report making to complete dissertation.

25th Month to 36 Month


zz Concentrate the study in your area/subject
zz Intensification of library study of your PG subject
zz Learn to defend your dissertation.

HOSPITAL POSTINGS, FIELD VISITS


You have additional postings as per stipulation of the council for e.g. in
medical science:
zz Oncology (Cancer hospital)

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Time Table for Three-Year Postgraduate Course 15

zz Psychiatry (Mental hospital)


zz Other medicine and allied subject institutions
zz Other surgery and allied subject institutions
zz Other OBG and allied subject institutions
zz Regional special hospitals
zz Regional high tech hospitals
zz Study visits to certain organizations/institutions field visits.
You have an obligation to participate and help the institution in all on
going National Health Programme e.g.,
zz IPPI (Intensive Pulse Polio Immunization)

zz Acquired immune deficiency syndrome (AIDS) surveillance

zz Acute flaccid paralysis (AFP) surveillance.

Do attend them without fail and have recording of all your


observations. Get the initials from your supervisory staff at the end of
each postings.

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CHAPTER Medical Ethics
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Involved in
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Postgraduate Work O
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INTRODUCTION
Human values in health profession constitute medical ethics. It is
formed with beliefs and values.
Under legal aspect of patient care, we have four types of negligence.
They are:
1. Civil negligence where patient can demand compensation.
2. Criminal negligence where patient can approach police for action.
3. Corporate negligence such as patient could not get proper care for
lack of staff in the hospital, patient succumbs to a fracture by fall in
the nursing home.
4. Contributory negligence such as patient does not reveal his sensitivity
to penicillin which cause damage, patient is on self medication.

O
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CD

MEDICAL ETHICS
Is a broader terminology which deals with traditions and conventional
ethical values related to values and norms. Here social action aimed at CD
E
achieving good desirable end e.g.
• Consent tn

• No malpractice
• No negligence
• Confidentiality.
Medical Ethics Involved in Postgraduate Work 17

Bioethics
Enunciated by Beauchamp and Childress. It deals with problems that
has arised from recent developments in science and technology e.g.
zz Cloning

zz Amniocentesis

zz Surrogate mother

zz Euthanasia

zz Organ transplantation.

PG dissertation/research work ultimately reach patients who are


human subjects and laboratory animals. This work is of two types:
1. Clinical research (Direct value in patient management).
2. Nonclinical research (No direct value in patient management).

Heteronomous and Autonomous Ethics


Heteronomous Ethics
Deals with desirability of a thing particularly its usefulness in health
practice which is subject to external law e.g.
zz Sterilization of an unmarried girl/woman is not accepted

zz Defective newborn cannot be allowed to die

zz Terminal stage cancer patient cannot be allowed to die.

Autonomous Ethics
Deals with desirability of a thing particularly its usefulness in health
practice which is independent of others or under one’s own law e.g.,
zz Patient wants his treatment by traditional system of medicine

zz It is sinful to interfere natural reproductive process (e.g. abortion) by

religious norm
zz Family need a male child for progeny though it is 4th pregnancy.

PERSPECTIVE OF MEDICAL ETHICS


Babylonian code is the oldest in existence now preserved in the Louvre,
treats of property, of criminal offences, of marriage laws and, what is of
great interest to us, of laws relating to medical practice.

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18 Synopsis, Dissertation and Research to PG Students

Egyptian code of medical ethics meted out punishments for


malpractices even more severe than those of the Babylonian code.
Ancient India has the high heritage of bringing us the code of
conduct in medical practice with:
zz Atreya anushasana

zz Charaka samhita

zz Sushruta samhita.

Hippocratic oath has been adopted as a pattern by medical men


throughout the ages. In this noble code of ethics the disciple or graduand
is shown the dignity and responsibility of his calling, and there is urged
upon him the duty of respect for his school, university, of making freely
available any new discovery, of maintaining professional secrecy and
refraining from gossip, of seeking above all the benefit of the patient,
and of taking no mean advantage of the position of medical adviser
(Appendix-4).

Nuremberg Code
The code enunciated in 1947. The Nazi physicians were fined for crucial
experiment on prisoners and on concentration camps.

The Declaration of Helsinki: (Appendix-5)


In 1964 the committee on international organization of medical
sciences and world medical organization formulated the declaration of
Helsinki. It has given many protocol where certain ethical issues are to
be included.

The WHO Declaration of Geneva


In 1982, this has given us code of conduct and international guidelines,
which are authentic ethical guidelines.
International code of medical ethics:
In 1983, this has given us many ethical principles. The salient principles
of this code are:
First:
zz No judgment on behalf of patient

zz No self advertisement unless permitted by law

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Medical Ethics Involved in Postgraduate Work 19

zz Referral done for fee is prohibited


zz Dignity in discharging duty as physician
zz Safeguarding patient’s confidence
zz Using only professional channels for discovery
zz Act only in patient’s interest
zz No certification without verification.
Second:
zz Loyalty
zz Confidentiality

zz Humanitarian on duty.

Third:
zz Respect to professional colleagues.

The Indian Medical Council Act


Act of 1956 has given the code of medical ethics to registered medical
practitioners.
This has enunciated the Professional Medical Ethics to Physician
and Medical Practitioners.
The code of medical ethics is framed under section 33 of the Indian
Medical Council Act 1956.
At the time of registration, each applicant shall be given a copy of the
following declaration by the Registrar concerned and the applicant shall
read and agree to abide by the same.

General Principles
zz Character of the physician
zz The physician’s responsibility
zz Advertising
zz Payment of professional services
zz Patent and copy rights
zz Running an open shop (dispensing of drugs and appliances by
physicians)
zz Rebates and commission
zz Secret remedies
zz Evasion of legal restrictions

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20 Synopsis, Dissertation and Research to PG Students

MCI Code of Ethics


In 1980, this has given guideline on research and experiment in human
subjects. It has dealt with the following aspect:
zz Doctor-to-doctor relationship

zz Interprofessional relationship

zz Consultation

zz Case of interference

zz Citizen care.

This also provide canceling licence and other disciplinary action.

The Patient Self Determination Act


This Act of 1990 USA is self explanatory. Patient can direct health
profession. He can reject the treatment.

MAJOR PRINCIPLES OF MEDICAL BIOETHICS


zz Principle of doing good which is called beneficence in ethics.
zz Social and distributive justice to one and all with a view to serve
the ill with fairness, equity and impartiality. This is called Justice in
ethics.
zz Full freedom, right of individuals to make choice, right to make
decision for themselves. This is called the respect for autonomy in
ethics. Other names are ‘self determination’ and ‘liberty’.
zz Principle of not harming patients (First do not harm!). This was
true for old crude treatment and is also true for recent advance
technology. This is called nonmaleficence in ethics. It is also called
‘fraternity’ which means brotherhood maintained in society.

Other Principles of Medical Ethics


For the Profession
zz Qualification
zz Responsibility
zz Payment of fees
zz Unethical advertisement
zz Rational use of drug
zz No commercialization.

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Medical Ethics Involved in Postgraduate Work 21

For the Individual


zz Right to health.

Reaching/Achieving Ethical Principles


By approach of:
zz Being virtue of prudence
zz Being virtue of compassion

zz Being virtue of trustworthiness

zz Being virtue of integrity.

MAJOR RULES
The right to be respected: Each person has a right to call for assistance
and help by his fellowmen at emergency and illness. A doctor has his
role play to treat the sick. There is social obligation for a doctor to treat
the sick and for a patient to seek medical help. In this interaction all
individuals have the right to be respected.
Truth and confidentiality: An individual often has many angles of events
in his life time. Illness is such one event. If a person is suffering from
tuberculosis or leprosy or psychological disturbances, the situation
is true. The truth is that he is a patient of a given disease which may
make him social outcast. The information on this will be with doctor or
profession which is connected largely with patient’s privacy.
An individual has every right to privacy over the issue of truth.
This aspect of professional secrecy is called confidentiality. Medical
oath and medical declaration makes a doctor obligatory to maintain
confidentiality.
For example of truth in human life:
zz Homicide
zz Fitness for service

zz Insurance coverage and claim

zz Accident (hit and run).

For example of confidentially in human life:


zz Hospital or survey health records
zz Confidential information collected by doctor for the purpose of

treatment

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22 Synopsis, Dissertation and Research to PG Students

zz Scientific publication of a case study when pseudoname is used


zz No gossip is done by profession on information about patient’s
sexual habit.

Troubling Problem in Truth and Confidentiality


zz A patient is diagnosed to suffer from STD
zz A patient is HIV +ve is on OT table for an emergency operation
zz When Insurance company compels for personal information
zz Highly infectious disease of patient
zz A person is selected as railway driver is found to have color
blindness (Truth takes off the job. Confidentiality can kill thousands
of innocents).

Doctor Patient Relationship


Physical distance may deter people from making use of health services
provided, but social distance is more important in the present day
alienation of health care. It is a question of deculturizing medicine
and reculturing it to suit the sociocultural pattern in a given region or
country. In this process whole-person-medicine is important. People
want to be treated as whole beings and expect more from medicine than
a mere scientific study of their individual organ.
Health of individual is reflected by his family and his community.
Ethical issues involved are:
zz Waiting time

zz Demanding prompt and personal attention

zz Patient from class IV socioeconomic group do not conduct

themselves
zz Cumbersome hospital procedure

zz Doctor’s language not understandable

zz Expected information on sickness not available.

Organ Donation
Treatment now is involving use of organ to the sick. It is not possible
without formal procedures. Values and norms are drawn and ethical
issue is a crucial factor.

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Medical Ethics Involved in Postgraduate Work 23

Common organs used in donation are:


zz Kidney
zz Cornea

zz Blood

zz Liver

zz Fetal brain tissue

zz Bone marrow

zz Heart.

Demand for organs have created ethical issues.


Requirement in organ donation:
zz Compatibility in live donors
zz Close relatives for good taking

zz Will/consent/declaration is required

zz Age of donor must be above 3 years

zz Brain death establishment required on many occasion.

Ethical Problems
zz Very expensive
zz Compatibility in donor
zz Force and compulsion

zz Waiting time and loss of lives for want of organs

zz Money, agency, commission uproar the issue (unethical practice of

commercialization).
We have Anatomical Gift Act of USA, Human Organ Transplant Act
UK and World Health Assembly Proclamation on these issues.

PRACTICE OF MEDICAL AND BIOETHICS


Informed Consent
Real, adequate information and adequate knowledge about research in
understandable language when given to human volunteers in research
constitute informed consent. This allows human volunteer’s willingness
and participation in the research. Literacy and socioeconomic class of
volunteers will have a direct bearing on the validity of informed consent.
Medical jurisprudence under Indian Penal Code (IPC) worth seven
sections deals with consent and the consent to procedures on person.
Any consent obtained under fear or misconception does not constitute

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24 Synopsis, Dissertation and Research to PG Students

an informed consent. Ethical issues involved are: (a) completeness of


information (b) acceptable and understandable (c) no fear of injury (d)
no misconception (e) human volunteer in sound mind and sound body
(f ) comprehension by human volunteer is provable, and (g) research is
of high benefit and low risk.
Individual has autonomy and right to take decision. The patient
must get required details of information. No consent should be obtained
under fear or by force. This is to take care of human dignity, privacy and
positive health.
There must have been monetary compensation, which should be
legally recorded. This should not be made a commercial consent.

Right to Information and Choice


Trust play a role here. Though Doctors know better, it is obligatory that
patient should be appraised of all available information in diagnosis and
treatment.

Protecting the Vulnerable


Avoiding as far as possible experiment and research in children,
pregnancy, mentally ill and on subordinate workers, will protect the
vulnerable.

Equal Access
No bias should be there in service/product/drug/screening on
patients. It should be free of race, caste, creed, sex and religion.

ETHICAL REVIEW COMMITTEE


Each Health Science Institution, where PG teaching and training is going
on, should have an Ethical Review Committee, which is an authorized
body to give clearance to all PG research activities.
Receiving clearance from the ethical committee of your institution
is a must and is obligatory on your part to mention the same in the
synopsis of dissertation and in the regular dissertation topic ‘material
and methods’.
Each HOD in their respective departments shall review the topic
and research as they form Subethical Review Committee. Later, it is to

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Medical Ethics Involved in Postgraduate Work 25

be brought to the meeting of Ethical Review Committee of the College,


which is expected to meet once in three months.
Ethical Review Committee should constitute following members which
shall be around 6 to 8 members:
zz Director of the institute

zz Principal as academic chief

zz Dean/medical superintendent as administrator

zz One member of public

zz One Judge/advocate of the cadre of district session judge

zz One expert on drug

zz One general practitioner

zz All heads of the departments.

These members assess the issues/dissertations carefully and give


clearance to go ahead with dissertation/research work.
While submitting, should follow the following protocol:
zz Objective of study
zz Justification for suggested investigations

zz Proof for harmlessness of investigations

zz Experimental design, sample size, type of universe and duration of

the study
zz Consent required (if other than routine investigation are done)

zz Earlier findings of similar studies

zz Benefits to patients

zz Risk to the patients

zz Confidentiality

zz Ethical declaration.

Matched Pair Design Human Voluntary Research


This involves stringent rules which are regulated by National and
International codes of conduct. In human voluntary research; to seek
the benefit to the human subjects; intend to have potential benefit to
a group of patients and a long-term benefit to humanity apart from
getting gain in human knowledge in the management of diseases and
disabilities.
Human volunteer research is guided by the following ethical principles:
zz Ethical consideration of research on the patient
zz Medical confidentiality

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26 Synopsis, Dissertation and Research to PG Students

zz Informed consent
zz Doctor and volunteer relationship
zz Profession not doing anything for the sake of money.
Types of human volunteer research are:
zz Simple classical human volunteer research

zz Within a patient design

zz Factorial design.

Drug Trial
Drug or substance which is given for therapeutic purpose in a clinically
proved case is a traditionally accepted phenomenon. Of late, new
chemotherapeutic agents, new vaccines, new antibiotics and other new
drugs are being invented. All of them have to undergo drug trial or a
clinical trial before getting approval and before releasing to the market
for patients’ use.
The normal procedure is animal experiments when proved
effective is taken for clinical trial or drug trial. Drug trial follows
the same bioethical code of conduct which is applicable to human
experimentation.

LABORATORY AND CLINICAL TRIALS


Research is an essential tool needed for progress anticipated in medical
field. Medical research is carried out on animals and human beings
apart from laboratory procedures in the laboratory. Thus research ethics
provides the strict guidelines for research on laboratory animals as well
as on human volunteers.
Human experiment is required to provide the expected changes
in physiological and pathological changes in health and disease and
impact of an intervention. In the present situation all community
health measures are time tested as harmless procedures before they are
implemented in community health services.
Research ethics denotes an area of faithful discrimination of doing
right or wrong in professional activities.
Clinical case review, change of drug or therapy, allowing for
additional investigations, selection of patients or volunteers for future
observations, retrospective record review, experiments on animals
followed by human experiments are the committed fields in research
ethics.

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Medical Ethics Involved in Postgraduate Work 27

Animal and Experimental Research


Basically animal experiment differs from qualitative assessment on
humans. Exploitation of animals if done unethically leads to an offence.
It is mandatory to have (a) a separate animal house; (b) trained
animal curators; (c) availability of veterinary surgeons’ advice.
The regulation of colleges of health sciences, hospitals and research
organizations under affiliation and licence covers the legal requirement
for a better animal welfare.

Legal Requirements
1. Animal accommodation:

Mouse
zz 80 sq cm per animal
zz Temperature 24–25°C
zz Relative humidity 45–64%
zz Change for ventilation once in 12–15 hours
zz Bedding by sawdust and wood shavings
zz 12–16 hour exposure to sunlight provision of more space when
breeding.

Guinea Pig
zz 0.1 sq m per guinea pig
zz Temperature 15–18°C
zz Relative humidity 60%
zz Change of ventilation once in 4–6 hours
zz Bedding wood shaving
zz If caged, floor made of nearer mesh.

Rabbit
zz 0.7 sq m per rabbit
zz Temperature 10–18°C
zz Relative humidity 50%
zz Area with good ventilator
zz Bed by saw dust, wood chip.

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28 Synopsis, Dissertation and Research to PG Students

Dog
zz 1.3 sq m per dog
zz Temperature 5–15°C
zz Relative humidity 50%

zz Ventilation change once in 10 hours

zz Bed raised off the floor.

2. All procedures should be under anesthesia


3. After recovery from anesthesia, care taken with humaneness for
its revival.
4. Other procedures:
—— If sacrifice is indicated, early permission should be obtained as

per the International Committee on Laboratory Animals (ICLA)


which is supported by the World Health Organization.
—— If sacrifice is permitted, follow humaneness in proper disposal

of the dead animal with dignity.


—— Learn technical aspects of the study before handling or before

undertaking animal experiment, which allows no animal


suffering.
—— In case of inbred colony development set up of standards for

gnotobiotic animal safety, this allows experimental animals free


from all pathogens and microorganisms.
—— If associated with a specific organism in the animal experiment,

care should be taken for lessening animal suffering and


provision for reverting to normalcy.
5. Killing and disposal:
—— Should be done under anesthesia

—— Always to use known painless procedure of destruction.

—— Should always have a trained animal technician

—— Disposal with respect by incineration and maceration.

6. Biohazards:
—— Caution should be taken for animal and animal waste disposal.

—— Face mask, glove and other personal protection should be on

the guard.
7. Record:
—— Meticulous labeling of animal cage

—— Accurate record of experiment

—— Label should have nature of experiment, number of experiments,

name of licence, date of experiment started, species and sex of


animal and procedure being followed.

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Medical Ethics Involved in Postgraduate Work 29

8. Animal supplies:
—— Should be from accredited dealers

—— Should have been specifically bred

—— Should follow import licence procedure (according to the

Importing Manual Order 1971 and Disease of Animal Act 1950).


—— Choice of animals should be conditioned by cost, availability

and facility.

Recent Advances in Animal Experiment


(Use of Tissues and Organs)
zz It is for Biological Material Research
zz It is more advanced, ethical than traditional animal experiment.

Basic Techniques In Animal Experimentation


zz Handling of animals
zz Restraint of animals
zz Withdrawal of body fluids
zz Sedation
zz Anesthesia
zz Care of surgery
—— Preoperative

—— Record

—— Identification

—— At surgery

—— Postoperative

zz Biopsy technique
zz Microsurgery.

HUMAN EXPERIMENTATION
Human experimentation is regulated through a bioethical code of
conduct which had emerged from time-to-time through the following:
zz Nuremberg Code,1947

zz Helsinki Declaration,1964

zz Modified Helsinki Declaration,1975

zz ICMR Guidelines,1980

zz CIOMS and WHO Guidelines,1982

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30 Synopsis, Dissertation and Research to PG Students

Ethics do not permit human experimentation as an alternative to


available successful accepted procedures.
Ideal human experimentation is one which is:
zz For individual benefit

zz For family benefit

zz For society benefit

zz With informed consent

zz Noninvolving children, pregnant women, lactating and mentally ill

patients
zz No compulsion or rigid force on prisoners.

Large scale human experimentation is called Community Health


Research. Examples of community health research are AIDS vaccine
trial, Framingham study for Cardiovascular Diseases.
Check points in human experiments:
zz Local ethical committee like hospital ethical committee

zz Medical college ethical committee

zz Institutional ethical committee

zz State ethical committee

zz National ethical committee

zz International ethical committee.

Ethical Issues Involved in Cancer Patients


Who are in Terminal Care
zz Right to information on the prognosis of the patient and his family.
zz Torture with pain and suffering of illness which cannot be allowed to
end even with voluntary euthanasia.
zz Belief in telling the truth
zz Living will at terminally ill stage
zz Right of dying with dignity
zz Long-term damage caused to the body and mind by chemotherapy
and radiotherapy
zz Affordability of family when lost.

General Ethical Principles in Genetic Research


zz All research in human genetics should have a review committee
zz Investigator must obtain the informed consent
zz A child’s refusal to participate must be respected
zz Investigator must provide all information to human subjects

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Medical Ethics Involved in Postgraduate Work 31

zz Burden and benefit must be equally distributed among all section


of the society
zz Pregnant and nursing mothers should not be subjects in genetic
research
zz Secure safeguards for the confidentiality of the research data.

Genetic Disorders
In case of pedigree studies family members are not entitled to know
each other’s diagnosis. Recruitment procedures are free of elements that
unduly influence the decision to participate. Potential risks and benefits
should be discussed thoroughly with subjects.
Indian National Science Academy has given guidelines for care and
use of animals in research.
The following experience and specifications are to be obtained:
zz Proper handling of animals used in experiment
zz Learn adequate skill to give anesthesia

zz Learn adequate skill to perform experiment

zz Always maintain them in standard environment

zz Surgical procedures are permitted under anesthesia

zz After experiment, care should be given for its recovery by appropriate

measures
zz In all possible ways, avoid sacrifice of any animal

zz In case of specific requirement of sacrifice, do it with humane

sacrifice under anesthesia


zz In vitro test are always preferred to animal experiment

zz In all, avoid pain and suffering

zz Give respectful disposal to the dead and remaining and not

indiscriminate throwing.
National Science Academy, National Animal Protection Act and
Amendments; also Animal Welfare Regulation have suggested “Animal
Ethical Committee” in Health Science Institution, who give accordance
to animal experiment in research with suggested guidelines. The
committee shall consist of:
zz Head of institution

zz Head of academic activities

zz Faculty from physiology

zz Faculty from pharmacology

zz An advocate or a lawyer practicing law

zz Veterinary doctor

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32 Synopsis, Dissertation and Research to PG Students

zz Social worker
zz Heads of departments who conduct animal experiment.
These members assess the issues of research work and give clearance
for animal experiment in postgraduate research activities.

ETHICAL PROBLEMS IN AIDS, CHILDREN


AND MENTALLY ILL

AIDS
Human immunodeficiency virus testing can be done only on three
allowed specifications. They are for:
1. Blood safety
2. Surveillance and for
3. Diagnosis.
HIV testing cannot be done on request, either by government or any
other agency request.

Ethical Issues
zz Pretest counseling, consent and testing are proper procedure in HIV
testing
zz It is not affordable by patient/public
zz Information should be given only after western blot confirmation
and only after consent
zz Post-counseling and psychological support is needed for test
positive cases
zz Outcast and movement restrictions of HIV +ve is not advocated
zz It is unethical to refuse treatment of HIV/AIDS patients.

Children
Up to 14-year of age, ethical issue to children holds good, since planning
commission has suggested 0–14 years groups as children or pediatric
group.

Ethical Issues
zz Involving children is not proper.
zz Consent of parent or guardian (this is very necessary for even
treatment of a child by the doctor).

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Medical Ethics Involved in Postgraduate Work 33

Mentally Ill
This group does not constitute an indispensable group for any study/
research.

Ethical Issues
zz Better totally avoided
zz Consent of parent/guardian is must even for treatment
zz Legally third party consent does not hold well in these cases.

All Postgraduates should remember to verify the issues like (a)


Violation of ethical values such as fund misuse, safety (b) Informed
consent be there in each structured questionnaire (c) No duplication of
other’s material (d) No fabrication and (e) No plagiarism.

NEWER AREAS OF ETHICAL INTEREST

Ethical Issue of Symbols


Correct use of symbol for red cross, for a doctor, for a hospital, for an
ambulance and for pharmacy is advocated (Fig. 4.1).

Red cross symbol; this can be used only by Red Cross


  Movement members and Army Medical Corps

This symbol can be used by the Doctor

This symbol can be used by a Hospital

This symbol can be used by an Ambulance

This symbol can be used by Pharmacy

Fig. 4.1  Correct use of medical symbols

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34 Synopsis, Dissertation and Research to PG Students

COMPUTER ETHICS
Computer ethics is an applied ethics which studies ethical problems
aggravated, transformed or created by computer technology. Computer
enabled invasions of privacy by economically powerful government
agencies became a public worry and led to books, articles, government
studies and proposed privacy legislation. Computer scientists started
adopting codes of conduct for their members. Weizenbaum of 1976 on
computer power and human reason is a classic example in computer
ethics.

e RESEARCH
Online arenas include experimental studies, surveys, interviews, field
observations and participant observations. Real time chat rooms are
new method of communicating unlike previous forms. This blurs
the distinction between what is private and what is public in online
communities. Ethical guidelines are to be provided to protect chat room
participants’ privacy.

ETHICAL ISSUE WITH ALTERNATIVE MEDICINE


Following alternate medicine have found their right place that are totally
accepted by the community for their accessibility, affordability and
simplicity and naturality which the ancestors had earlier patronized as
a panacea for all illness.
zz Ayurveda

zz Unani

zz Siddha

zz Homeopathy

zz Naturopathy

zz Herbal medicine

zz Yoga

zz Massage

zz Acupuncture

zz Magnetotherapy.

Allopathic or modern medicine which has become more expensive,


not being natural and cannot give relief in many illness; has raised
doubts about its efficacy with the people. However, both trained and
untrained persons practicing the alternate medicine has brought into
focus the quacks who are entering the main stream.

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Medical Ethics Involved in Postgraduate Work 35

Value assessment is required in alternative therapies. Can this


be done in a healthy attitude? Ethically, standards and qualifications
of doctors in alternate medicine are to be insisted. If inappropriate
preparations are used to treat, what could be the ethical value of
alternate medicine?
Allopathic practitioner practicing with alternative medicine and
vice versa is unethical. Indiscriminate use of modern medicine and
allopathic medicine are producing adverse results.
Ethical correction was tried through by the integrated medicine
training and practice but has not been successful.
On one side Government of India is promoting Indian system of
medicine. On the other side knowledge and ethics of its practitioners
is ethically questionable. Ethical issues arise due to the poor inter-
professional relationship.
With high acceptance and increasing confidence on its efficacy
of Indian people, Indian system of medicine should be streamlined
by enforcing ethical, moral, social standards through Central Council
of Indian Medicines and Central Council of Homeopathy which can
regulate the practitioners.

MEDICAL ETHICS AND COPRA


To keep up values and guidelines for doctors’ service to patients’ illness,
COPRA came to existence in 1986 with a view to attend to the Rights to:
zz Safety

zz Choice

zz Information

zz Education

zz Redressal.

The Consumer Protection Act (COPRA), 1986 was enacted to better


protect the interest of consumers. With globalization of economy and
enhancement of consumerism, the importance of the Act has multiplied
manifold.
Under the Act, Consumer Forums at District (570) , State (35) and
National level established to provide simple, inexpensive and time
bound justice to consumer complaints against any defect in goods
or deficiency in services including unfair restrictive trade practices
adopted by any person.
The Act was amended in 1991 and 1993. To make the Consumer
Protection Act more functional and purposeful, a comprehensive

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36 Synopsis, Dissertation and Research to PG Students

amendment was carried out recently by the Government and brought


into force from 15th March 2003. The Amendment Act is expected to
greatly strengthen the consumer movement in the country.
The word “Consumer” is defined by the Government of India as
“Anyone who buys goods and avails services for his or for her use is a
consumer. Any user of such goods and services with the permission
of the buyer is also a consumer.”
It was in 1992 Justice Balakrishna Erade ruled that COPRA is made
applicable to Medical profession also without hesitation.
Any unethical practice and damages during treatment or operation
has to be decided within 90 days. If appeal is to be made to higher Forum
that must be within 30 days.
As per sec 24 A , the period of limitation for filing the complaint is
2 years. If a patient made false complaint, he can be fined 10,000/- as
per sec 26.
As per section 27, the Forum can provide provision for imprisonment
from 1 month to 3 years with fine of ` 2000 to 10,000/- in case, a doctor
or patients does not obey the Forum’s decision.
On 17th December 2002 a long awaited comprehensive Amendment
Bill to amend the Consumer Protection Act, 1986 has been passed by the
Parliament and became an Act an Important Amendment which came
into force from 15.3.2003.
zz Creation of benches of National Commission and State Commissions

and holding of circuit benches


zz Prescribing time-frame for admission of complaint, issue of notices

and disposal of complaint


zz Recovery of compensation amount ordered by the redressal agency

through medical certificate case in the same manner as arrears of


land revenue
zz Provision for issue of interim orders by the redressal agencies

zz Establishment of Consumer Protection Council at District level

zz Revision of pecuniary jurisdiction in respect of redressal agencies at

different levels.
—— District Forum Up to ` 20 Lakhs
—— State Forum Above ` 20 lakhs up to ` One crore
—— National Commission Above ` One crore
Doctor acquires scientific knowledge, technical skill and human
understanding to treat the suffering of a person who is emotionally
disturbed and desperate due to many constrains. The doctor is expected
to apply his knowledge and skill with a true spirit of service and devotion.

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Medical Ethics Involved in Postgraduate Work 37

Professional Misconduct and COPRA


State Medical Council is authorized to check professional misconducts.
But professional misconduct lead to defective service and hence brought
also under Consumer Protection Act (COPRA). Criminal operations,
treating while under alcohol influence, association with unqualified
for treatment, neglect of patient, wrong investigations leading to wrong
diagnosis, experimentation of patient, wrong certificates and wrong
reports all come under COPRA.

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CHAPTER
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1-
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Designing Research O
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INTRODUCTION
The purpose of research in health sciences is to establish the extent of
occurrence of chance of health events. Normally, occurrence of an event
will be as though they are occurring in nature and not by chance.
Research design should satisfy ( a ) verification of PG 's hypothesis
( b) totally should control bias in the study and (c) should be possible
to generalize with accuracy the outcome of research in the society or in
the nature.
In designed studies of community medicine, it will have coverage
of ecological aspect in the causation. This becomes part of study in
community based study.
Research studies are undertaken on events occurring on an individual
basis or group basis. The main area of concern in research are:
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• Diagnostic tool LU

• Therapeutic tool _
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• Investigative tool
• Screening tool. CD
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The therapeutic may be medical, surgical, radiological or chemical
in nature. tn
Such research conducted will help and enrich our scientific
knowledge eventually helping improving health practice and , which will
benefit individual, society and the community.
Since inferences are made on the basis of research, it must be
designed in a scientific way to avoid bias, mistake and wrong conclusion.
This is to safeguard against harmful effects in health practice.
When the dissertation is undertaken, student is expected to
encounter few problems in spite of guidance, advice and systematic
Designing Research 39

approach. Such problems are solved by student following a PROTOCOL.


The Protocol is a framework constructed on a systematic manner for
conducting dissertation work. This is outlined under preparation of
synopsis of dissertation/research.
After selecting the willing subjects for studies in clinical trial,
they should be subjected for general screening examination to check
their fitness for the study. This is done soon after the receipt of Ethical
Clearance. Screening of experimental animals also follows similar
protocol. Normal protocol is as under:
zz Initially identification points are written

zz Required information of clinical trial or animal experiment is written

zz Clinical examination including suggested investigations are done

zz Biological habits are recorded

zz Depending on exclusion criteria or inclusion criteria, the volunteers

or animals are considered for the study in dissertation.


Short gap in the protocol in case of animal experiments or human
experiments: In case of nonwilling participant, a short gap is given for
adjustment. If there is maladjustment, that participant can be dropped
from the study. This period is usually 15 to 20 days; by which time
preparatory work will be going on.
In case of animals, it is made sure that they are healthy. They are
allowed to acclimatize to laboratory conditions. Age, gender and weight
delineate their selection for the study by the postgraduate.

SPECIFIC OBJECTIVES
Main objective of research will be for practical application by enriching
or furthering the scientific knowledge.
Clinical practice, medical practice and health practice are improved
by way of research studies and observations made in research.
Cure rate, healing trend, success of operation, preventive measure,
technique of investigation, technique of surgical procedure when found
of better value, surely benefit the patient and the community.
No research work can be good and acceptable without specific
rationale objective.
Before specific objective is described, the research worker should ask the
following questions and put forth the available answers:
zz What is your plan for research?

zz Is it single man’s work or team work?

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40 Synopsis, Dissertation and Research to PG Students

zz Who are the respondents in the study?


zz What are the items in the study?
zz What is the duration of the study?
zz Place of study
zz Expected outcome of the designed study.

NEED OF DESIGN IN RESEARCH/PROJECT/


THESIS/DISSERTATION
No research design is acceptable without the need based concept.
Is there a need for such a study will answer our point for starting and
designing the research procedure.
The need for research design is crucial in the following conditions:
zz When unexpected outcome is expected in patient management

zz When unexpected outcome is expected in group mana­ge­ment

zz When there is burning public health problem which need elucidation

zz When a hypothesis is to be proved

zz When already existing research findings need re-evalua­tion.

DRAFTING OF OUTLINE
When a topic is selected for research, it should be with a specific
hypothesis, which need verification by research.
Regarding conducting the research, following questions are put and
answered:
zz Who?

zz Where?

zz On whom?

zz When?

zz How?

The research to be done must have been need based and important
in its application to the society.
As far as possible, check the resources for your study.
Drafting the outline itself is a preplanning process, which is an
essential part of the research methodology.
It is very essential that the study design adopted should aptly
suit the study. While describing the materials and methods, special
emphasis should be given on cases design, control design and design
of variables. The protocol should be carefully designed leaving no room

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Designing Research 41

for ambiguity. Tests that are used and equipment that are used should
be clearly described. It is always advisable to conduct a pilot study in a
research design. This pilot study helps in preparation of final proforma,
methods to be used in the proposed study.
The design should be such that it should be easily replicable by
another researcher, any where in the world. The results derived from
the study should also pass scientific scrutiny and be acceptable when
presented in a scientific congress or to a journal for publication.
Drafting the outline constitutes:
zz Structured questionnaire
zz Pilot study

zz Postulation of hypothesis

zz Dummy table preparation

zz Anticipated verification points for proving the hypothesis

zz Library references

zz Methods and material

zz Data analysis

zz Tests and investigations used

zz Anticipated end point

zz Possible end point for practical application.

NATURE OF TOPIC TO BE SELECTED


When a topic is selected, it should reflect the nature of the study.
Title must be expressed in a concise way, but should impart much
information on the nature of study, type of study, duration of the study
and specifications of the objectives of the study.
Following facility should be made available in deciding the topic:
zz When a topic is programmed, we should be in a position to postulate
a hypothesis which should be acceptable by a research forum
zz Decision must be taken on research team, study team, place of

research, the universe of study (viz, cases, patients, families, blood


samples, etc.)
zz The duration of the study must be specific, and normally it will be

time bound (to one year study) as per specifications of the affiliated
universities
zz There must be provision for clinical, medical, health implications in

the designed research

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42 Synopsis, Dissertation and Research to PG Students

zz Possible resources in terms of men, material, and money should


have been worked out.

STEPS IN DESIGNING
Following steps are described in research methodology, in all types of
studies in health sciences, in all scientific protocol, and in designing a
research, which are to be kept in mind.

First Step
zz Preplanned and proposed area of study
zz Each department or unit should have topics ready for which any
investigator can choose for dissertation, for thesis, for UGC project,
for ICMR project. This will help the Institution to have much awaited
benefits by the studies
zz It will be still ideal if logistics of such prescheduled topics are made
available by earlier studies. This activity minimizes fallacy and bias
which normally seen in a new venture
zz With this, by clarifying the requisite, we would have formulated the
topic.

Second Step
A complete and thorough library reference of related studies, journals
and texts are made and got written in a book, which should be in the
form of annotated bibliography (Appendix II).
All available research outcome of similar studies are collected item
wise through annotated bibliography, which will help us in specifying
the problem definition.
It also justifies the research protocol. The proposed research is
readily accepted based on these available information.
From step two the questions that arise, hypothesis that are put forth
are answered in a better way and are made authentic and answerable in
any forum.

Third Step
Creation of an appropriate study design is done.
zz Descriptive study

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Designing Research 43

zz Analytic study
zz Experimental study.

Specification on
zz Individual based
zz Group based
zz Interview based
zz Cross-sectional
zz Retrospective
zz Prospective is made.

The Type of Trial is to be Defined


zz Clinical trial
zz Screening test trial
zz Diagnostic test trial
zz Program trial, etc.

This Step Follows the Working of Logistics of


zz Participants
zz Equipment
zz Expertise
zz Time.

Fourth Step
This is a major step to be taken on the following areas:
zz Deciding on sample size (refer the chapter on biostatistics).
zz Proforma or structured questionnaire preparation.

This Contains
zz Identification data
zz Socioeconomic data
zz Family data
zz Past history
zz Details of present health examination
zz Specific areas of research questions
—— By oral reply

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44 Synopsis, Dissertation and Research to PG Students

—— By investigation
—— By observation.
zz The choice can be structured or open questionnaire
zz This is finalized by doing a small study (Pilot study).

Fifth Step
The data collected is tabulated to form a master table. By now, you
would have prepared many dummy tables. (As many as dummy tables
prepared shall be ready for entry of tabulated data).
Simple tables, cross tables and statistical tables are prepared.
Application of statistical tests and critical analysis of data is done.

Sixth Step
The entire data including tables are presented through type script, got
corrected by the guide, and final report is prepared.

DESCRIPTIVE STUDY
Main aim of descriptive study is to investigate the characteristics of a
specific group of population. Normally components included are deaths,
diseases, disabilities, discomfort, dissatisfactions, deviation from social
norm and deviation from statistical norm (seven Ds.).
Positive aspect of health like medical fitness,life expectation, validity
years, person year in good health are justified in descriptive study.
Somatic variables like pulse, BP, respiratory rate, serum cholesterol,
PPBS, CSF constitute the body of descriptive study.
Nonmeasurable qualitative data like behavioral pattern, knowledge,
attitude and practice enrich the descriptive study.
Investigations may also cover events to study demographic,
biological, social, cultural and environmental aspect in descriptive
study.
In this type of study, ideal correlation of risk factors with:
—— Person

—— Place

—— Time

Are undertaken through cross-sectional and longitudinal studies.


Differences between cross-sectional and longitudinal studies are
tabled below (Table 5.1):

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Designing Research 45

Table 5.1  Differences between cross-sectional study and longitudinal study


Cross-sectional study Longitudinal study
 Single examination at one point  Repeated over long time
 Can be projected to the universe  It is an universal project
 When repeated, it can be serial  Cannot be repeated easily
survey description
 Fast approach  Slow approach
 Inexpensive  Expensive
 Study of natural history of disease is  Possible to study NHD
not possible
 Study of risk factors is not possible  Possible to study risk factors
 Gives prevalence  Gives incidence

Steps in Descriptive Study


zz Objective of the study is defined
zz Universe of the study is defined
zz Sample size is determined
zz Operational definition of topic is given and criteria of diagnosis is
laid down
zz Sampling procedure is followed
zz Listing of required variables and attributes are done
zz Proforma/questionnaire is prepared
zz Data is collected
zz Analysis is undertaken
zz Formulated hypothesis is tested.

Uses of Descriptive Study


zz Gives morbidity
zz Gives mortality
zz Gives clue to the cause
zz Gives ideas for hypothesis
zz Help in health planning and evaluation
zz Help in identifying the determinants of diseases
zz Help in identifying the distribution of diseases.

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46 Synopsis, Dissertation and Research to PG Students

CASE CONTROL STUDY


It is a type of analytic study.
It is started at effect and goes back to cause detection.
One of the basic requirement of case control study is a built up good
information system in an organization (Table 5.2).

Table 5.2  Differences between case and control study


Case study Control study
 Study group  Control group
 Effect on health is seen  Effect on health not seen
 Diagnostic criteria should prove  Not necessary
diseased
 Exclusive criteria is important  Inclusive criteria is important

Design Used in the Study


Exposed to effects Case (with cancer breast)

e.g.,  Users of oral Control
   contraceptives (without cancer breast)
        ↑     ↑
  In the past    Now

Analysis Used for the Study


Exposure: Smoking 5 cigarettes per day (an illustration)
Yes No Total
Case (Cancer lung) a b a+b
33 2 35
Control (No cancer lung) c d c+d
55 27 82
a + c b + d a + b + c + d
88 29 117
Odds ratio (Cross product ratio) is = ad/bc
33 × 27
= = 8.1
  2 × 55

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Designing Research 47

Inference
Cancer lung associated with smoking of 5 cigarettes per day is 8.1 times
more.
Case control study is useful in:
zz Frequently occurring health problems
zz Done in less cost and in small duration

zz Identifying risk factors.

Steps
zz Design of study
zz Hypothesis is made
zz Record system is reviewed
zz Diagnosis criteria is fixed
zz Case and control study is done
zz Data is collected
zz Odds ratio is determined.
Examples of case control studies:
zz Maternal smoking and birth defects
zz Viral infection and bells palsy

zz Exercise and myocardial infarction

zz Occupation and cancer of urinary bladder

zz X-ray and blood cancer.

COHORT STUDY
Group with similar characteristics constitute a study group called a
cohort, e.g.
zz Birth cohort

zz Marriage cohort.

The study in cohort group proceeds forward from cause to effect.


Both prospective and retrospective are possible or even the combination
of both is accepted.
Cohort study is the study of healthy group which has not exposed to
effects, but ill-effects are seen during the prospective study follow-up.

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48 Synopsis, Dissertation and Research to PG Students

Design of the Study


Healthy population

Exposed to cause Not exposed to cause

Develop disease Not Develop Not


develop disease develop
disease disease

Analysis of the Study


   Disease

Developed Not Total


developed
Exposed group a b a+b
c d c+d
Not exposed group
a+c b+d a+b+c+d
a
Incidence among exposed = × 100
(a + b)
c
Incidence among not exposed = × 100
(c + d)
a/(a + b)
Relative risk =
c/(c + d)
[a/(a + b)] – [c/(c + d)]
Attributable risk = × 100
a/(a + b)
Uses of Cohort Study
• Directly, we can calculate
—— Relative risk

—— Attributable risk

• Multifactorial study is possible.


• Natural history of a disease can be identified.

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Designing Research 49

Examples of Cohort Study


zz Risk factors in coronary heart disease.
zz Risk of oral contraceptive in developing cancer.
zz Risk of smoking in developing lung cancer.

CLINICAL TRIAL
It is a controlled experimental study that is used to assess safety and
efficacy of treatment for human diseases or human health problems.

Steps in Clinical Trial


zz Put forth hypothesis
zz Define
—— Study population

—— Sample size

—— Study period

zz Specify exclusion criteria and inclusion criteria


zz Allocation of treatment is randomized
zz Follow-up done
zz Data is collected
zz Data is analyzed
zz Conclusion drawn.
Specific criteria in case of clinical trial with new treatment:
zz Animal study and experiment are done to substantiate drug action
and drug toxicity
zz Later human study is undertaken.

Stages of Human Study


Phase I: For safety and tolerance.
Clinical trial is conducted with 20 to 100 cases.
Phase II: For potential effectiveness and method of administration.
Clinical trial is conducted with 100 to 200 cases.
Phase III: For treatment effectiveness and additional safety.
Clinical trial is conducted with 500 to 1500 cases.
Phase IV: For long-term effect.

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50 Synopsis, Dissertation and Research to PG Students

Clinical trial for post marketing studies is done for long-term


effect.

Design of the Study


to new treatment
1.
Exposure Outcome
to old treatment
Type 1: Parallel design study

  Phase I       Phase II
to new treatment   A   to new treatment  B
2. Exposure
to old treatment  B to old treatment  A
Type 2: Cross over design study

Phase I         Phase II

Drug A   Drug B
3. Exposure
Drug B   Drug A
Type 3: Drug change design study

Randomized Clinical Trial


Selection by random procedure, for clinical trial helps in:
zz Reducing bias

zz Equal chances are allowed

zz Comparability is accepted.

Methods of randomization:
zz Alternative assignment

zz Coin flipping

zz Card shuffling

zz Throwing dice

zz Using the random table.

For example of randomization:


—— On duty day every first case is taken to treatment A

and

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Designing Research 51

—— Every 5th case is taken to treatment B.


—— All odd numbers to treatment A
—— All even numbers to treatment B, etc.

Steps in Randomization
zz Required number of treatment A (say 1 to X) is labeled
zz Required number of treatment B (say 1 to Y) is labeled
zz (1) and (2) are put to cover and sealed
zz All envelop are shuffled
zz They are numbered from 1 to X (or A to Z)
zz By using random table, a particular cover is taken and treatment is
given.

BLINDING
In clinical trial bias is a major concern. This can be overcome by blinding.
Blinding is a method of reducing the bias in a clinical trial.

Types of Blinding
zz Single blind: Treatment is concealed from participants
zz Double blind: Treatment is concealed from investigator and the
study group
zz Triple blind: Treatment is concealed from investigator, participants

and evaluator.
Double blind method is very common type of blinding used in
clinical trials.

OTHER ASPECTS OF DESIGNING


Important aspect of designing in day-to-day practice is to adopt techno-
economic feasibility. There are many feasibility studies available for
reference. CSIR, ICMR, and UGC have many feasibility studies with
special reference to techno-economic feasibility.
The issues noted in this area are:
zz Availability of subjects/cases/participants

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52 Synopsis, Dissertation and Research to PG Students

zz Availability of equipment/investigations
zz Availability of expertise
zz Availability of time.

COLLEGE LEVEL ACTIVITY IN STUDY DESIGN


zz Project and assignment at undergraduate level helps both students
and staff to acquire skills of conducting research
zz All such studies conducted in a college/hospital will be the property
of said college/hospital
zz Each department or unit should undertake preliminary survey to
map out required area of research for the department. This helps to
assign a topic to a new postgraduate dissertation work
zz Research committee at college level should help the departments in
maintaining standards in research activities
zz Periodic review of postgraduate dissertation work is required for any
required modifications or for guidance
zz Research committee should be coordinated with college level ethical
committee for the required specifications
zz All postgraduate dissertation work should be (i.e. the study/research/
experiment/field work/clinical trial, etc.) time bound and is expected
to be completed in twelve months. This is in appropriation with the
syllabus of affiliated university of health sciences (or universities)
zz College can welcome funding agencies for the research activities.

MINIMIZING ERRORS AND BIAS


In research studies, different types of errors and different types of biases
are seen. We should overcome them. One of the time test method is using
control group in research study. Subsequently randomization by using
random tables followed. Third method is known as allocation method
wherein one will allocate the case or the family or a patient from a given
number say from even number or odd number as the case may be.
In clinical trials, role of placebo is very critical in taking care of errors
and biases.

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6
CHAPTER
Preparation
of Synopsis of
Dissertation/
Research

INTRODUCTION
As part of learning curricula, Postgraduates are assigned a dissertation
which is part of the fulfillment of PG degree in his/her examination. He/
She learns to carry out a research project called dissertation under the
guidance of a University qualified guide.
In majority of University of Health Sciences, the preparation for
dissertation lasts for 6 months wherein a synopsis is submitted (summary
content of the dissertation) by the Postgraduate to the University. When
accepted, he/she will have one year for actual study period which follow
another 16 months for report preparation for university submission.
Synopsis is the preliminary justified particulars of future dissertation
and brief description of work outline on scientific basis. Normally, it
is based on a proforma prescribed by the affiliated university. This is
a requisite for submission to the affiliated university for the topic
acceptance. The synopsis is a prerequisite in a script for approval and
registration of dissertation topic by the said university.
Review of synopsis is done by the experts at university who proclaim it fit for:
zz Registration
zz Provisionally fit for registration subject to suggested corrections

effecting and resubmission


zz Not accepted for registration.

The criteria they follow are based on a set of research criteria fixed
from time-to-time and also medical council at the national level.
Basic understanding of the components in synopsis make the
postgraduate to attend to its completion and submission for registration.

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54 Synopsis, Dissertation and Research to PG Students

BASIC INFORMATION
Basic information refers to identification of information of the post-
graduate in the column provided like name, address, college studying,
course studying and subject of the study, date of admission to the course.
Date of admission to the course is to stipulate the submission of
synopsis within six months of admission to the course.

TITLE OF THE TOPIC


Selection of topic must be relevant to the course of study selected.
zz The title should be concise but informative

zz The title must be short, active and brisk in flavor to attract the

attention
zz The title should not be abbreviated (except on certain usage of

internationally accepted abbreviation)


zz Dissertation topic given should be as brief as possible but should

carry as much information as required.


Since there will be duplication of the study title, following assertion is
required:
zz To check college list of dissertation to avoid duplication

zz To check university list of dissertation to avoid dupli­ca­tion

zz In case if department/guide have thought of a greater need of a topic,

then the study can be suffixed to the place of conducting the study
which solves the problem of duplication.
Examples:
1. “A study of ultrasonography in clinically suspected cases with
gallbladder pathology presenting in Jawaharlal Nehru Medical
College, Belgaum.”
2. “A study on the impact of leprosy control in an urban field practice
area attached to Karnataka Institute of Medical Sciences, Hubballi.”
3. “A study on the health profile of under five children in Rural Health
Training Center (RHTC). Attached to Karnataka Institute of Medical
Sciences, Hubballi.”

NEED OF THE STUDY


Give a brief introduction to the work you intend doing by focussing
on present literature on the subject. Specify the need of your study
undertaken. The reason for undertaking the study could be:

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Preparation of Synopsis of Dissertation/Research 55

zz For local benefit


zz For benefit over other line of management
zz For improvising the existing diagnostic tool

zz For uncovering the burning health problem

zz Connected with National Health Programme

zz Need for studying the pattern of a particular regional endemic

disease, which is peculiar to the region.


About 200 words can be in a separate enclosure along with the
university proforma.

OBJECTIVE OF THE STUDY


Careful outline of objective form basis of dissertation work.
Normally 3–4 objectives of the study can be outlined, looking to the
feasibility, applicability and utility of the study.
Objectives should focus on the key questions raised in the need of the
study. About 100 words of objectives to be delineated and enumerated,
singly, which serve as the basis of future study observation and study
discussion.

REVIEW OF LITERATURE
Review of literature is always larger unit of any dissertation. Reading this
unit reflects the proficiency of the postgraduate student. Each review
requires separate write up. This can be annotated bibliography. Review
in different heading is appreciated.
It is suggested to write 3–5 references pertaining to the subject and
work already done and published. It should be related to the objectives
of the study.
Postgraduates should be acquainted with publications in health
sciences. Scientific work done already or research work done already
and got published should be reviewed which gives an idea on research
and on how to go about PGs own dissertation.
Literature review gives room to peep into problems on research
methodology. Review overcomes duplication of work which is not
permitted by the university. If it is not duplicated, it shall allow PG to sail
smoothly on the research project.
Publications are primary source of literature and abstracts like
PubMed, IndMed, etc. are secondary sources. Both are part and parcel
of research.

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56 Synopsis, Dissertation and Research to PG Students

Review of literature is different from reference. It brings us the


information about author, place and year of the study. It points out in
brief, the outcome of study including sample size, and sampling. In
other words list of the study is depicted in the review of literature which
is a modified version of annotated bibliography.
Sample of review of literature is given in appendix.

MATERIAL AND METHODS


As name implies, material used and methods adopted in the study is
briefly described. An effort should be made to bring about the following
(which are specific requisite of Material and Methods of any Research
Study):
zz Source of data

zz Method of collection of data including sampling procedure

zz Does the study require any animal experiment

zz Does the study require any animal experiment (other than routine)

and intervention (other that routine) on patients selected


zz Mention must be made of the clearance obtained from the College

Level Ethical Committee.

LIST OF REFERENCES
It is expected to provide recent study reference, done in the past 5 years,
in/on the same topic/subject. Four to six references are expected of a
postgraduate in the synopsis.
One, should note that references are entirely different from review
of literature.
The referred material is put in an acceptable manner, like author,
title, volume number, serial number of the said volume, page numbers,
year of publication, place of publication in case of journal. It differs with
text, editorial, mimeography, etc. a sample reference is made available
in Appendix 9.
Reference gives us the source to where the material is available, but
do not specify any outcome or summary.

GUIDE AND CO-GUIDE


As per the norms by medical council, one guide per one postgraduate
per term of admission is allowed. In case of paucity of guides, concession

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Preparation of Synopsis of Dissertation/Research 57

is given to heads of the departments to guide TWO postgraduates per


term of admission.
If this guideline is overlooked, there are chances of rejecting the
registration of topic of dissertation.
College or Institution should takes care in this regard. However,
postgraduate student should also help the college/institution in the
norms of guide selection.
Whenever supplementary and interdepartmental coordination for
the study is required, such department faculty can be referred to as
co-guides.
For example surgery postgraduate doing a study where Histo­
pathology aspect is mainly emphasised, he should obtain a co-guide,
who shall be a faculty from the department of Pathology.
Similarly, Medicine and Biochemistry, Microbiology and
Community Medicine, Radiology and Medicine, Skin and sexually
transmitted diseases (STD) and Microbiology, etc.
Sociologists, biostatisticians, super specialty faculty in the same
department can also serve as co-guides, helping and co-guiding the
candidate.
If the study is in rural or urban field practice area faculty at RHTC or
Urban Health Training Center (UHTC) can be co-guides.
In all, guide or co-guide should fulfill the medical council guidelines
of having 7 years of teaching experience after their PG qualification, in a
recognized Institution.

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7
CHAPTER Know-how on
Actual Dissertation/
Research

The term Dissertation often used as a synonym with project, thesis,


study, case study, research, clinical trial.
Dissertation work should help PGs to have good publications in
National and International journals. They are going to be useful and
found beneficial in shaping their future career like
zz Interview

zz Promotions

zz Obtaining scores

zz Getting research grants

But, Universities of Health Sciences and Medical Council have


stipulated certain criteria and defined Dissertation as a formal, often
lengthy treatise or disclosure, especially the one written by a PG candidate,
as a part of fulfillment of PG degree award.
It should contain: (Appendix 8)
zz Title

zz Preface (Introduction) containing aims and objectives

zz Survey of previous work called the review of literature

zz Material and methods

zz Results or observations

zz Discussion

zz Summary

zz References.

To improve the quality of actual dissertation work, it is suggested to


have a small initial study with a small number of cases called pilot study.
When data, on rough basis, collected on small sample, which give good
foothold on the study. This helps to improve structured questionnaire

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Know-how on Actual Dissertation/Research 59

and standardize the proforma. It is advisable to have a pilot study that


should precede any dissertation work. Pilot study overcome future
logistic problems, short comings in methodology and allows additional
required data to include in the main study.

CONTENT
Initially dissertation should depict the content in an order. Pagination is
not required for certificates, acknowledgement and content.
Preferably content should have all titles mentioned earlier and
details of tables, figures and diagrams.
Sub grouped items should be considered under appendix. The idea
of giving content is for quick search of a required item when we refer
back the dissertation.

TITLE
Title should be short, informative and concise, without any unaccepted
abbreviations. The title should describe the content in limited words.
Title invariably present the covered objective, type of study, duration
of the study and place of study.

INTRODUCTION
The introduction should not have long preambles, should specify why
you did start the study, should state the purpose, the hypothesis being
tested, the method employed and your specific objectives.
Introduction should not exceed more than 500 words.
Precisely, introduction should state:
zz The nature and scope of the problem
zz The rationale for the present study.

Introducing the title/topic is of two types. One is by quick approach


or the other by slow approach (Figs 7.1 and 7.2).

Fig. 7.1  Quick approach   Fig. 7.2  Slow approach

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60 Synopsis, Dissertation and Research to PG Students

If the description is given from the beginning on topic/problem


of the dissertation to the reader, it is slow pace introductory note in
dissertation.
If the built up narration is given which follow the description of
topic/problem it is slow approach of topic introduction in dissertation
write up.
All in all, introduction emphasizes the aspect of (a) problem/topic
of dissertation (b) left out aspect of dissertation topic and (c) what is
intended to be undertaken in the present study.

REVIEW OF LITERATURE (APPENDIX 9)


Under the above, one should give strictly pertinent references. When
review of literature is done, critical approach to the reliability of previous
work is expected.
One should use description regarding retrospective studies, since
same old repetition or retrospective rambling may be boring.
In the narration, appropriateness should be considered for
enumerated objectives of the study. Narration should have a consistent
theme.
When reporting the previous/earlier similar studies, one should not
give conclusion from the work being reported.

BODY
Material and Methods
Material and Methods form main item of the body, which outlines the
scientific approach. At most importance should be given to sample
size, how selection is done (criteria of selection), sampling technique,
data collection procedure and investigations done (both routine and
special). If detailing is there of a unique method, it can be in appendix.

Results/Observation and Discussion


In Results/Observation one should follow the order of satisfying the
objectives. It is better to formulate relevant tests to be applied. With the
help of tables, stratification is expected in observation. Wherever relevant,
use of diagram, figure, chart, map and illustrations are to be used.

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Know-how on Actual Dissertation/Research 61

Analysis of the data should have statistical measures, confidence interval


and level of significance.

Discussion
In discussion, the outcome can be similar to other such studies or may
differ from earlier studies. Establishing inter and intra relationship
among variables, discussing as to why it has disagreed with other
studies and arriving at generalization from findings is the critical step
in research studies. Required and relevant correlation is a must and
spurious correlation is avoided. Always make a note on limitations
wherever wanted. The scope of future work is established from the
present study. A comparative statement of outcome from earlier studies
with the present study make a good presentation at discussion.

SUMMARY AND CONCLUSION


In giving summary one should avoid all experimental details.
In summarizing the issue, the schematic shall be the problem
studied, the outcome observed and result got. Drawing the major
conclusions from the study is always imperative.
Observation and discussion can be together, but separate is
preferred. Similarly summary and conclusion can be together, but
separate highlighting is preferred.
Limitation can be separated but is preferred in discussion.

REFERENCE (APPENDIX 10)


Reference highlights that the given study material available at the
mentioned source. It gives an idea of where the material is available and
not about its detail.
Reference material like journals, books or special publications is
documented in such a way as to be made easily available to refer by the
reader. The source of reference should be made available and should be
easily accessible.
Proper reference overcomes duplication and plagiarism. Very
common reference may be avoided, to make the material more
qualitative. But all special or rare studies should be cited.

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62 Synopsis, Dissertation and Research to PG Students

Vancouver
In the year 1978, International Committee of Medical Journal editors met
in Vancouver BC, Canada. This has given a common style of reference
for major Medical journals. This also is found useful for cataloguing.
Leurs R, Church MK, Taglialatela M. H1-antihistamines: inverse
agonism, anti-inflammatory actions and cardiac effects. Clin Exp
Allergy. 2002;32(4):489-98.
Guilbert TW, Morgan WJ, Zeiger RS, Mauger DT, Boehmer SJ, Szefler
SJ, et al. Long-term inhaled corticosteroids in preschool children at high
risk for asthma. N Engl J Med. 2006;354(19):1985-97.
PubMed Style is accepted for journals titles in their abbreviations.
More authors are there, usage of et al. is advocated rather than writing
all authors. Be it remembered that full stop, comma, semicolon, colon
all are important in reference.
von Itzstein M, et al. Rational design of potent sialidase-based
inhibitors of influenza virus replication. Nature. 1993;363(6428):418-23. 
Here the reference is at the order of appearance in the text. This is
very helpful for the reader (in research) to locate the source of data and
further to log on to its detail. There will be no waste of time in this set
up. Vancouver style of writing reference is preferred to other method in
publication of a scientific article.

Harvard
It existed earlier for many decades. But in the year 2001 American
Psychology Association formulated this style. Author- year style which
is popularly called was quite common till the introduction of Vancouver
style.
For example,
Maynard Smith, John (1998). “The origin of altruism,” Nature 393:
639–40.
 Chernin, Ei (1988). “The ‘Harvard system’: a mystery dispelled”, British
Medical Journal. October 22, 1988. pp. 1062–1063.
In a smaller context, in abstract work, in other than research work;
it is always expected to have the reference in Harvard style, i.e. arranged
alphabetically by Author. In projects, dissertations and in small scale
research work which are part of fulfillment of PG degree, Harvard style is
preferred to Vancouver style.

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Know-how on Actual Dissertation/Research 63

Digital reference often mentioned as software bibliography is


nowadays common with Endnote and Library Master in the present day
practice. Whichever style it may be, one should not miss any reference
and all should be traceable. One should avoid duplication of reference.

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8
CHAPTER Biostatistics for
the Dissertation/
Research

Without statistical analysis and interpretation, the scientific data is just a


data and cannot serve as health information.
Hence, basic understanding of Biostatistics to every PG student is
mandatory and should be undertaken in PG dissertation/research, lest
the weight age shall not be given as per the guidelines of the respective
councils (Medical, Dental, etc.).

INTRODUCTION
Primary objective of statistics is to provide reliable, relevant and up-to-
date data to medical profession to carry out day-to-day technical and
scientific routine studies. Statistics are of following types:
zz Health statistics which mainly deals with normal health aspect.

zz Medical statistics which deals with data of case management

zz Vital statistics which deals with data pertaining to vital events like

births, deaths etc.


zz Biostatistics which deals with data of biological and biosciences.

These data are presently called “Health Information” and the system or
organization which works for it is called “Health Information System.”

Definition
WHO has defined statistics as:
A mechanism for the collection, processing, analysis and transmission of
information required for organizing and operating health science and
also for research and training.

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Biostatistics for the Dissertation/Research 65

Mainly, statistics has a major role and is of great importance in


National Health System. It has become a basic tool of management in
public health.
Following terminologies are commonly used in elementary statistics:
Data: They are discrete observations and do not carry any
meaning.
Information: They are tabulated data which give meaning.
Intelligence: They are transformed information based on social and
political value.

Characteristics
Each individual is characterized by certain physical characters like
age, sex, weight, Hb%, BP, WBC count, etc. Similarly, there are some
socioeconomic characters like occupation, literacy, income. These
qualities are called characteristics. These characteristics are grouped
under two categories:
1. Attributes: Characters that are not measurable are called attributes.
e.g. sex, death, survival, etc. The person having attribute is countable
and attribute as such is not countable.
2. Variable: Characteristics that are measurable are called variables.
For example, height, Hb%, etc.

Importance
Importance of statistics are enumerated as under:
zz It is a guide for medical care services
zz It is a tool for research

zz It is a measure of health status of a community

zz It identifies health problems

zz It identifies health needs.

zz It helps in providing a scientific basis for recording, collection,

compilation, presentation and analysis.


zz For comparing health status between:

—— Individual to Individual.

—— Society-to-Society

—— Hospital-to-Hospital

—— Community-to-Community

—— District-to-District

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66 Synopsis, Dissertation and Research to PG Students

—— State-to-State
—— Country-to-Country
zz For planning and health administration
zz It helps in finding out:
—— Impact of a health program and health management

—— Success or failure of an operation

zz It helps in health program evaluation


zz It is a key to all health administration.

Biostatistics and Health Science


Application of statistical principles and methods are necessary, not
only for understanding of biological and medical sciences but also
for effective practice in health professions. Biological, clinical and
laboratory data are variable and hence need statistics for understanding
and interpretation.
In health science, a course on statistics is necessary because:
zz Decisions on diagnosis, prognosis and therapy are based on

concepts of probability.
zz Interpretation of tests, observations and measurements require

knowledge of variations of physiological, observer and information.


zz Epidemiological facts are necessary for controlling or preventing

disease.
zz Health workers who are primary data generators should know about

statistics.
zz Describing health level, health trend and health resources are

possible through interpretations and inferences.


zz Statistics in health sciences foster critical and analytical mind which

are required during the course and later in professional practice.

Parameters
Parameter is a characteristic which describe population. When we say
average size of family in India is 5.3, infant mortality rate (IMR) in India
is 71 per thousand LB, they indicate parameters.
When a sample is described by a unit it is called statistic. In a sample
study of a village in Agra showed average family size as 6.0 and IMR of the
same village as 74 per thousand livebirths, then characteristic describing
this sample is statistic. Parameter is always single for a universe when
compared to statistic which are many folds (for many samples).

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Biostatistics for the Dissertation/Research 67

Estimates
Estimates are observed values of a sample or a population. We select,
for example, 50 nurses for their Hb%. We have average Hb% of Nurse
Population. Mean Hb% of 50 Nurses is 10.8 G% and population mean of
nurse population is 11.6 G%.
10.8 and 11.6 are single numbers. They are called point estimates.

Point Estimates
Suppose we want range of Hb% in 50 nurse sample and in nurse
population. This is called range estimates commonly called, confidence
interval (CI).
Point estimate in 50 nurse sample:
It is 10.8 G% because sample mean is best estimate of population mean.
Range estimate in 50 nurse samples:
Let us say SE is 0.7 and interval with 2 times SE (it is 1.96) below and
above the mean will be:
10.8 ± 2 SE (correctly 10.8 ± 1.96 SE)
10.8 ± 2(0.7) = 10.8 ± 1.4
Lowest is 10.8 – 1.4 = 9.4
Highest is 10.8 + 1.4 = 12.2
So range estimate is (CI) = 9.4–12.2 Hb%
In statistical estimate, we always use mean (point estimate) and
Range (confidence interval) (Fig. 8.1). It can be represented as:

Fig. 8.1  Statistical estimates

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68 Synopsis, Dissertation and Research to PG Students

Descriptive Statistics
Descriptive statistics are used to describe or characterize data by
summarizing them into more understandable terms without losing or
disturbing much of the information.
Examples
zz Pie diagram

zz Bar chart

zz Frequency polygon

zz Mean, median, mode.

Inferential Statistics
Inferential statistics consists of a set of statistical techniques that provide
predictions about population characteristics based on information in a
sample taken from the population.
Example
By Hb% data of 50 nurses given above, we can infer as under:
zz 50 nurses selected is a sample of study

zz Mean Hb% is 10.8

zz Confidence interval (Range estimate) is 9.4–12.2.

We infer from the sample study that mean Hb% of nurse population
is 10.8 and CI is 9.4–12.2 (± 1.96 SE). So we have predicted values for
nurse population by sample nurse population. It is called inferential
statistics.

Scale of Measurement
Measurement is the assignment of numerical to objects or events
according to a set of rules. For example, chest measurements of nurses are
done with measuring tape which is calibrated by centimeters or inches.
According to Stevens (1946), there are four types of measurement
scales for variables.

1. Nominal Scale
When people, object or event are categorized say A, B, C, D, etc. or 0, 1,
2, 3, 4, etc. we are assigning a number or a letter as labels. It is categorical
scale.

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Biostatistics for the Dissertation/Research 69

Examples
Sex 0 = Female
1 = Male
Hygiene 0 = Worst
1 = Bad
2 = Good

2. Ordinal Scale
When characteristics are put into categories which give meaning, but
distance between the categories are not properly known, it is ordinal scale.
For example in final BSc (Nursing), Asha, Rita and Zinat secured I, II and
III Ranks respectively. This does not tell us by how many marks they differ?
Examples
Socioeconomic class:
1 = Low
2 = Middle
3 = High
IQ 0 = Idiot
1 = Moron
2 = Normal
3 = Genius

3. Interval Scale
When characteristics have fixed and equal distance between them, we
refer it as interval scale.
(Divisible unit) (No gap)
Fahrenheit temperature 98° F 98.2 F
99° F 98.3 F
100° F 98.4 F
Inch scale 1′′ 2.5 cm
2′′ 5.0 cm
Examples of discrete “interval scale”
(Gap is there)
(Indivisible unit)
Para 1
2
3
Family members 4
5
6

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70 Synopsis, Dissertation and Research to PG Students

4. Ratio Scale
It is a precise level of measurement. Here characteristics have equal
intervals.
Zero in the scale is determined by nature (not arbitrary). Ratio
scale has characteristics of interval scale but has a true zero point as its
origin.
Example
IQ Mental age/Chronological age
DF Indoor illumination/outdoor illumination
NPU N2 retained/N2 intake
Quetelet index Weight/Height
Calorie Coefficient, etc.

Raw Data, the Array, Frequency Distribution


Mass of raw data is available when they are collected. They do not mean
anything for a profession to infer. No useful information is immediately
evident from a mass of raw data. They are the array of number, words
and response. These collected data need to be organized in such a
way that the information they contain clearly reveals the pattern of
variation.

Table 8.1  Frequency table showing protein-energy malnutrition (PEM) cases


according to age in a sample survey

Age group Tally mark Frequency (Year)


<1 IIII 4
1–4       34
      IIII
5–9     10
10–14 II 2
Total 50

Frequency table is prepared by determining the range, tallying the


frequencies (Table 8.1).

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Biostatistics for the Dissertation/Research 71

Steps of Tabulation of Data


Tabulation is the first step before data is analyzed or interpreted.
Following principles are followed in tabulation:
zz Each table should have a number.

zz Each should have self explanatory and brief title.

zz Care is taken to give clear and specific legend.

zz Clear rows and columns are made.

zz It must be according to size or according to importance.

zz Number and percentage should be closer.

zz It should not be too large.

zz It should not be too small.

zz Uniform class interval is maintained, except in case of age distribution

where standard grouping of variable class interval is allowed.

Coding and Editing


Coding and editing are required for proper interpretation. When
collected data is entered with a decision of entering through code like 1,
2, 3 or A, B, C or X, Y, Z care should be taken for proper entry and proper
interpretation.
Example
All male = 01
All Female = 02
Single = 01
Married = 02
Widowed = 03
Awareness Yes = X
No = Y
At edition, care is taken to group or regroup a variable for proper
interpretation. This does not allow original meaning.
Example
Para 0, 1, 2, 3, 4, 5 is grouped to:
Para – Nil
Para – 1–2
Para – 2–4
Para – 4 +

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72 Synopsis, Dissertation and Research to PG Students

Demographic Data
Before we can assess the magnitude of the health problem posed by a
disease or impact of intervention we must have an idea of the size of the
community we are dealing with, its composition with respect to various
demographic characteristics and the magnitude of changes in relation
to vital events.
Demographic data relates to health and illness of population for a
community diagnosis.
They include:
zz Population characteristics—size, age, sex, etc.

zz Health profile—risk factors

zz Environmental factors—socioeconomic aspect

zz Morbidity, mortality, fertility

zz Birth, death, migration

zz Reticulation—boundary of census, unit, etc.

Tabulation of Mortality
Crude and specific deaths, disease and cause specific deaths, age and
sex specific deaths are considered for mortality data tabulation.

Tabulation of Morbidity
Disability, handicap, impairment, incidence, prevalence, population
at risk, rate, ratio and population are considered for morbidity data
tabulation.

Tabulation of Other Data


Fertility, current users, transition, relevance, health measures are
considered for other data tabulation.

Principles of Graphical Representations


We always use 2 axis and label them X and Y starting from zero to form
vertical and horizontal presentation. ‘X’ axis is marked with group, score,
class interval whereas ‘Y’ axis is marked with frequencies (Fig. 8.2). Ratio
between ‘X’ and ‘Y’ axis can be 3:2, 4:3 or 5:3 for proper presentation.

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Biostatistics for the Dissertation/Research 73

Fig. 8.2  Graph presentation through vertical and horizontal axes

Diagrams
In addition to table and graph, diagrams are used which furnish a good
impression of numbers and about idea. Real grasp of overall picture is
possible by a diagram. They are of course drawn based on set principles.

Bar Diagram
They are common and easiest diagrams for data presentation. They
indicate the frequency of a character. Spacing between bars should be
equal or more than half of the width of the bar. These are three types:
1. Simple bar
2. Multiple bar
3. Component bar.
Merits of statistics
zz It is a proof
zz It is a scientific approach

Demerits of statistics
zz It cannot be used without variables or attributes
zz It will be gross not actual (at the most is an average).

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74 Synopsis, Dissertation and Research to PG Students

Uses of graphs
zz Easy for comparison

zz Trends are observed with respect of time

zz Lay person can understand it

zz Median, percentile, quartile can be calculated

If, lot of fluctuation in graphs are seen, then semi log or double log
graphics are used. Here irregularities (that are seen in arithmetic scale)
are smoothened out.

DATA PRESENTATION
Data is discrete observation of event without meaning. When this
is reduced or summarized it becomes information. This information,
when interpreted with experience, constitute intelligence.
Thus, data, is redefined as:
“A set of values recorded on observation of your study.” If you see them
along, it has no meaning. If you want to give them a shape, analysis and
presentation have to be done.

Types of Data
zz Discrete (qualitative): They are called as attributes
For example, Sex, race
zz Continuous (quantitative): They are also called variables
For example, Height, weight

Source of Data
zz Study
zz Experiment
zz Survey
zz Hospital record
zz Clinical trial
zz Census.
Data presentations that are commonly expected by you are:
Table: – Simple table
– Cross table
– Tables with multivariables.

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Biostatistics for the Dissertation/Research 75

Charts: Bar
– Vertical
– Horizontal
– Multiple
– Component
– Histogram
– Frequency polygon.
Diagram:
– Line diagram
– Pie diagram
– Pictogram.
Need of presentation of data:
zz Easy for comparison
zz Trend observation with time possible

zz Lay people can understand

zz Median, percentile, quartile, etc. can be calculated

zz Impression are drawn

zz Conclusion are drawn

zz Assist in further analysis.

Simple table: Simple tables gives frequency distribution. It will have a


title, percentages may be added, as another column (Table 8.2).

Table 8.2  Distribution of gastroentritis (GE) cases,


talukwise June 2000
Taluk No.
Dharwad 39
Hubballi 23
Kalghatgi 14
Kundagol 9
Navalgund 5
Total 90

Cross table: Cross table provides information on occurrence of an event


in relation to another variable or attribute (Table 8.3).

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76 Synopsis, Dissertation and Research to PG Students

Table 8.3  Distribution of intestinal parasitism among protein-energy


malnutrition and non-protein-energy malnutrition children
PEM (n = 326) Non-PEM (n = 136)
Ascariasis 183 56.13 41 30.5
Giardiasis 153 46.93 8 5.88
E. histolytica 75 23.01 31 22.79
Threadworm 29 8.90 5 3.68

Multivariable Tables
More than two variables/attributes are put to analysis for a set of
character and is presented as multitables.
Bar chart
This can be – Simple
– Multiple
– Component.
By positions it can be – Vertical
– Horizontal.

Fig. 8.3  Simple bar diagram showing age of population in percent

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Biostatistics for the Dissertation/Research 77

Maintenance of cell, equal space, legend, units of variable are


common and are minimum requisite of a bar chart.

Fig. 8.4  Multiple bar diagram showing age of population by sex

Fig. 8.5  Component bar diagram showing (Proportional bar)


number of cases in outpatient and inpatient

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78 Synopsis, Dissertation and Research to PG Students

Fig. 8.6  Histogram and frequency polygon showing distribution of gastro-


enteritis (GE) cases at Karnataka Institute of Medical Sciences (KIMS), Hubballi
from January to August 1998
Salient point to note in frequency polygon:
zz Midpoints are connected including midpoint of previous interval

and following interval.


Line Diagram

Fig. 8.7  Line diagram showing number of cases by hour


of regain in consciousness after surgery

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Biostatistics for the Dissertation/Research 79

Pie Diagram

Fig. 8.8  Pie diagram showing duration of priming effect


with pancuronium in clinical anesthesia

The angle in Pie diagram is calculated by considering the circle as a


whole to the angle of 360°.
28/100 × 360 = 100.8 … Best
7/100 × 360 = 25.2 … Better
6/100 × 360 = 21.6 … Fair
20/100 × 360 = 72.0 … Good
11/100 × 360 = 39.6 … Not good
28/100 × 360 = 100.8 … Cannot appreciate
100/100 360
Calculation: Convertion for Pie diagram.
Pictogram:
zz It can be represented through map.
zz It can be represented by depicting items or figures.

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80 Synopsis, Dissertation and Research to PG Students

Fig. 8.9  Map showing the distribution of seven serological


+ve for plague in Dharwad district during 1996

When you tabulate, tables are of following nature.


zz Master table (all in one, consolidated format)

zz Dummy table

zz Real table

zz Final table

zz Table with statistical tests.

Dummy table: When you prepare proforma/structured questionnaire,


you should have an idea of possible table. Accordingly, sketch possible
dummies for simple and cross tables. To this you can insert your
tabulated data to make real table. Any number of dummy tables can be
prepared. But selection of required tables shall be for final tables in your
dissertation/research.
Medical Council of India, Dental Council of India, Indian Council of
Medical Research and University of Health Sciences, all views your work
with weightage only when you have done statistical analysis.

AVERAGES
Mean, Median, Mode are common averages used in statistics. In health
sciences, arithmetic mean is most widely used as average, because of its
specificity and less variation property.

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Biostatistics for the Dissertation/Research 81

Measures of Central Tendency


Meaning and importance: When the observations are clustered around
a central value, it is called central tendency. Normally, it is called
an average. This average is different for different observations. For
examples:
In Delhi, average age of student who enters medical course is
19 years.
In Dharwad, average age of student who enters medical course is
22 years.
In the above 2 cases, we observe many students cluster around 19
and 22 years at Delhi and Dharwad. This clustering is measured by
Measures of Central Tendency.

Computation of Mean, Median and Mode


For ungrouped data: 10 MBBS students have IQ as follows:
158, 139, 120, 146, 111, 99, 114, 156, 111, 94.
Arithmetic mean = 158 + 139 + 120 + 146+ 111 + 99 + 114 + 156 + 111 + 94
1248
Mean = =124.8
10
Median = we get mid value when they are arranged in an ascending
order.
94, 99, 111, 111, 114, 120, 139, 146, 156, 158
234
Median = = 117
2

Mode = Most fashionable number or the number which repeats most is


taken which is 111, is mode.
For grouped data: In a private hospital, 70 employees are working. Their
age distribution is as follows:

Age group (year) Number of employees


20–30 3
30–40 18
40-50 26
50–60 17
60 and above 6
          Total = 70

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82 Synopsis, Dissertation and Research to PG Students

Let us compute Mean, Median and Mode:

X x F (f )(x)  x − A (f ) (u) (f )(x)(x)


 
c 
(1) (2) (3) (4) (5) (6) (7)
Mid Age Frequency Mid value − Arbitrary
value group value ( A )
Class int erval
25 20–30 3 75 –2 –6 1875
35 30–40 18 630 –1 –18 22050
A (45) 40–50 26 1170 0 0 52650
55 50–60 17 935 + 1 17 51425
65 60–70 6 390 +2 12 25350
70 3200 5 153350
Note: A = Arbitrary value taken
Σfx 3200
AM = = = 45.71
Σf 70
n 
−F

= l+ 2 
Median ×C
f 
 
where l = Lower limit of median class
n = Number of observation
F = Cumulative frequency
f = Frequency of median class
C = Class interval
200 / 2 − 74 
\ Median = 120 +   × 10
 38
= 120 + 6.842
= 126.84
 f 
   Mode = l +  2  × C
 f2 + f1 
where l = Lower limit of median class
f2 = Frequency difference to preceding class of median
class

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Biostatistics for the Dissertation/Research 83

f1 = Frequency difference to succeeding class of median


class
C = Class interval
= 120 + (2/2 + 5) × 10
= 120 + 2.857 = 122.857
Comparison and uses of mean, median and mode: Mean is best known
and most widely used average. The median is not sensitive to extreme
scores and is useful when the data are skewed. The mode is most
frequently occurring value that has the largest frequency of scores
Table 8.4.

Table 8.4  Comparative table of central values


Mean Median Mode
Easy to calculate Easy to calculate Easy to calculate
Easy to understand Not easy to understand Not easy to understand
because not clearly defined
Gets influenced by an Not influenced by an Not effected by abnormal
abnormal value abnormal value value
— — We get more than one
mode

Learn Through Problem


Following are IQ of 10 individuals recorded in Psychiatry OPD.
158, 139, 120, 146, 111, 99, 114, 156, 111, 94,
Compute  mean,  median,  mode for the data.
Ans:
Sum = 158 + 139 + 120 + 146 + 111 + 99 + 114 + 156 + 111 + 94 = 1248
1248
( x − x )=
Arithmetic mean (AM) =124.8
10
Median: Arranged in ascending order, mid value is found out.
94, 99, 111, 111, 114, 120, 139, 146, 156, 158

234
= 117 = Median
2

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Mode: Repeatedly occurring value (Most fashionable).


94, 99, 111, 111, 114, 120, 139, 146, 156, 158
Mode = 111
Mode can be found out by
Mode = 3 (Median) – 2 (Mean)
= 3 (117) – 2 (124.8)
= 351 – 249.6 = 101.4

MEASURES OF VARIABILITY
Range
Mean Deviation (MD)
Standard Deviation (SD)
Coefficient of Variation (CV)

Range
The value between minimum and maximum (Highest – Lower).
Problem: Find the range for the following and comment (4 different set)

Set A 40 40 40 40 40 40 40 40 40
Set B 36 37 38 39 40 41 42 43 44
Set C 1 9 20 30 40 50 60 70 80
Set D 0 0 0 0 0 0 0, 0 360

Ans: A B C D
Total 360 360 360 360
AM 40 40 40 40
Range 40–40 = 0 –4 to + 4 More None
no variation 44–36 = 8 variation represent
zero variation 80–1 = 79 mean
variation is 8 360–0
360 variation

Mean Deviation
Compute mean deviation and SD for the following.
Q: 1Q of 10 individuals recorded at psychiatry OPD
158, 139, 120, 146, 111, 99, 114, 156, 111, 94

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Ans:

x (x − x ) ( x − x )2
158 33.2 1102.24
139 14.2 201.64
120 – 4.8 23.04
146 21.2 449.44
111 – 13.8 190.44
99 – 25.8 665.64
114 – 10.8 116.64
156 31.2 973.44
111 – 13.8 190.44
94 – 30.8 948.64
Σ ( x − x ) = 4861.6
2
1248 ÷ 10 Σ | x − x | = 199.6

Σ | x − x | 199.6 Σ( x − x )2
AM = x = 124.8 = =
10 10 n −1
4861.6
MD = 19.96 =
9
               SD = 23.24
Steps to calculate MD:
zz Find AM of IQ
zz Find mean deviation of each and their sum Σ | x − x | = 199.6

zz Divide Σ | x − x | =
by199 .6
number of observation to get MD
Steps to calculate SD:
zz Find AM of IQ
zz Find mean deviation of each ( x − x )

zz Find square of mean deviation of each ( x − x ) and their sum


2

Σ ( x − x ) = 4861.6
2

zz Divide Σ ( x − x ) by
2
= 4861
n – 1.6(since less than 30 values)

Σ(x − x )
2
zz Find the square root of above, i.e.
n −1

Standard Deviation (SD)


In SD, we can predict how far a given value is away from the mean.

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Fig. 8.10  Deviation from mean

Fig. 8.11  Diagram to show distance and coverage of values in a normal


curve, in reference to SD (x– ± 1SD, –x ± 2SD, –x ± 3SD)

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Coefficient of Variation
Q: Comment on the following: (To know CV another measure of
variability).
Height Weight
Mean 160 cm 55 kg
SD 10 cm 5 kg

SD
Ans: CV = ×100
x
10
CV of height = × 100 = 6.25%
160
5
CV of weight = × 100 = 9.09%
55

Inference
zz Height is more consistent than weight OR
zz Weight is more variable than height.

SAMPLE SIZE
In a scientific study, minimum number of size of sample is to be taken
which can be calculated by appropriate statistical formula.
Sample in Health sciences, can be animals, human volunteers,
families or a social unit.
Animals for research: They must be suitable and correct species.
Student should look into strains in a species for selection which is most
important.
Patients or human volunteers for research: Apart from suitability,
medical ethics go side by side in these samples. Willingness to
participate, informed consent and avoiding severely ill patients make
the study logical.
At the level of sample, exclusive criteria and inclusion criteria sorts
out specific characteristics of samples.
Sample: • It is a portion of population/patients/cases/animals taken
for the study.
• It should be a representation of the universe.

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When you select a sample, it is sampling, which may be:


• Simple random • Stratified
• Systematic • Multistage
• Cluster • Area
Sample size is dependent on number of factors. They are:
zz Prevalence of an event, e.g. TB.

zz Prevalence of a proportion, e.g, Knowledge

zz Variability of character

zz Desired accuracy (Appendix-11)

zz Probability level

zz Material resource

zz Time factor

zz Practicability

Sample size determined scientifically overrules bias.

Sample Size
When Prevalence/Proportion of a Disease is Known
A. Sample size determination when prevalence of an event/
proportion/condition/illness/disease is known:
Q: A tuberculosis survey was planned to be carried out in South India
by ICMR Team. Prevalence of tuberculosis in South India is 22%.
What should be the sample size at:
(i) 1% permissible error (accuracy).
(ii) At 20% accuracy.
(iii) As time bound study.
Ans: (i) If 1% permissible error, then
n = Number of cases (Sample) = 4Pq
L2
where P = Prevalence of tuberculosis

q = 1 – P (Proportion without TB)
L = SE permissible error in the estimate of proportion (P)
4 × 22 × 78
n = n= (1% of 22 is 0.22)
0.222
6864
= = 141818.18
0.0484
 n = 141818
(ii) If permissible error is 20%, then
4 × 22 × 78 6864
n= = = 354 (Or 355)
4.4 2 19.36

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(iii) For dissertation work, to be completed in a given period, size of


sample can be 354 or all cases which attend the hospital during
the period of one year (as time bound study) is quite acceptable.
It holds good for community based study also.
B. In case of proportion, we must determine
(i) The degree of confidence we are satisfied with (For example, we are
satisfied with 95% chance of the universe proportion is covered).
(ii) The range we are satisfied within predicting the event (For
example, it can be 2 percent point viz, ± 1 percent).
(iii) The likely values of binomial proportion (For example,
proportion of survival and proportion of death which is
represented as p and q respectively).
Illustration:
Q: HIV awareness is 80 percent. We want to be 95 percent sure of
predicting by the study within 2.5 percent on either side of the
estimated population (80% aware and 20% not aware). What sample
we would need to conduct such a study?
Ans: First, we assume, that the 95 percent of confidence interval covers
a distance of ± 1.96 SE under normal curve.
Second, we assume that the 95 percent of confidence interval is to
cover a range of 2.5 percent on either side of the estimated proportion.
Then,  1.96 sP =  0.025

0.80 × 0.20
(1.96) = 0.025
n
0.16
(1.96) = 0.025
n
 0.40 
(1.96)  = 0.025
 n 
0.784
= 0.025
n
0.784 = 0.025 n
31.36 = n
    983 = n
Therefore, if we think that proportion of occurrence is 80% we need
a sample of 983 to be 95% sure of predicting the event within 2.5% on
either side of the estimated proportion.
So, HIV awareness study requires minimum sample size of 983 at
95% CI and 5% error.

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Sample Size
Determination When a Control Group is Used
Q:  Determine the sample size for anemia survey by Hb% in a
community when a pilot study done show the following:
Hb% of 10 patients—13, 12, 14, 14, 10, 11, 12, 11, 11, 13
Hb% of controls—13, 12, 13, 14, 12, 13, 12, 13, 12, 13
Ans:  Size of sample is determined by (n)

    n n= t 2a × S 2
=
(d)2
2
where t a = t value for t table
[normally 1.96 (2 SE) is taken]
S2 = Pooled SD of both groups
d = Smallest difference likely to occur in 2 groups

Steps
1. Find out SD of study (patients) group
2. Find SD of controls
3. Find the Pooled SD = (S) by
n1S12 + n 2 S22
S=
S =
n1 + n 2 − 2
n1 = Number of study group S1 = SD of study group
n2 = Number in control group S2 = SD of control group
Patient group:
x1 ( x1 − x ) 2 ( x1 − x )2
13 0.9 0.81
12 – 0.1 0.01
14 1.9 3.61
14 1.9 3.61
10 – 2.1 4.41
11 – 1.1 1.21
12 – 0.1 0.01
11 – 1.1 1.21
11 – 1.1 1.21
13 0.9 0.81
121 16.9
–x = 12.1

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Σ( x 1 − x )2 16.9
S1 S= 1 = = = 1.87 = 1.37
n1 − 1 9
S12 = 1.87 (Square of SD is called variance)
Control group:

x2 ( x2 − x ) 2 ( x2 − x )2
13 0.3 0.09
12 – 0.7 0.49
13 0.3 0.09
14 1.3 1.69
12 – 0.7 0.49
13 0.3 0.09
12 – 0.7 0.09
13 0.3 0.09
12 – 0.7 0.49
13 0.3 0.09
127 4.1

–x = 12.7
Σ( x − x )2 4.1
S2 =
S2 = = = 0.455 = 0.67
n2 − 1 9
S22 = 0.46 (variance)

Pooled SD
n s22 + n s22
S = = n11s11 + n 22s22
SS =
+n
n11 +
n − 22
n22 −
(10 × 1.3722 )(10 × 0.6722 )
= (10 × 1.37 )(10 × 0.67 )
= =
+ 10
10 +
10 − 22
10 −
= 1.29
= = 11..29
29
Now, sample size required is ‘n’.
2
×S
22tt 2aa ×
2
× 11..96
S2 = 22 × 9622 × × 11..29
2922
n n
= =

n = (d)2 = 2 2

(d) ((00))2
12.8
n=
n = 12.8 = = 13
13
n = 00
Sample size of 13 is sufficient in the experimental study.

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There are other methods of determination of sample size. Students


are requested to discuss with Biostatisticians in this regard.

SIGNIFICANT TEST (TESTS OF SIGNIFICANCE)


Tests of significance are tests which are applied on qualitative or
quantitative data (which are tabulated) to find out their relationship
or association. It also tells us whether the outcome of the study has
occurred by chance or not occurred by chance (Table 8.5).

Table 8.5  Differences between variable and attribute


Variables Attributes
Qualitative Quantitative
Large sample tests Large sample tests
Z test for the difference Z test for the difference
between two means between two proportions
t test X2 test
F test (ANOVA) Rank correlation
Pearson correlation Order statistics
Nonparametric tests

Commonly applied tests:


Standard error (SE) of the difference between two means
zz SE of the difference between two proportions

X2 test
Z test
t test
zz Pearson correlation coefficient (π)

zz Spearman correlation coefficient (r)

Meaning of a Word Statistically Significant


We say smoking and cancer of lung are inter-related. It does not mean
that smoking causes cancer of lung. We normally observe that majority
of cancer lung patients are smokers. By appropriate statistical test (say
X2 test for a contingent table showing smoking and cancer both present
and absent), if we find that test applied is significant, then conclude
That there is significant relationship between smoking and lung
cancer.

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Significant Tests are Applied to Find Out


zz Any significant relationship is there or not
zz Any significant association is there or not
zz Is the occurrence only by chance
zz Is the occurrence not by chance
zz Significant level at a given ‘P’ level.

What is P Value (Probability)?


Range from Zero to One
It is the probable chance of occurrence of an event.
It expresses the relative frequency of occurrence of an event.
e.g. Tossed coin head or tail
Chance of male baby to new couple
A drug is better, what is the chance
Theory of probability (chance) may be binomial or multinomial. This
is just distribution in nature (Refer normal, binomial and multinomial
distribution).
Normally, in all health science data, at statistical inference,
we advocate minimum probability of 1 in 20, i.e. P 0.05. If higher
probabilities like 1 in 100 (P 0.01), 5 in 1000 (P 0.005) or 1 in 1000 (P 0.001)
are considered, then they are highly recommended; for, they infer the
higher level of significance in statistical analysis.
Suppose, the calculated value is higher than table value at probability
of 0.05, we infer as statistically significant. In case of higher probabilities,
we infer as “highly significant” or “very highly significant”.

Level of Significance
It is adjudged as the limit at which point of chance is operating.
Normally, in biological science P 0.05 which is called critical
probability is delineated, which refers to limit of 5%. Accordingly, 1%
(P 0.01) 0.5% (P 0.005) 0.1% (P 0.001) are the expression of chance limit
in scientific studies.
If the calculated value is greater than table value for the given P, then
it is unlikely to occur by chance.
If the calculated value is lesser than table value for the given P, then
it is likely to occur by chance.

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Learning Significance Test Through Problem Solving


Exercises

Standard Error of the Difference Between Two Means


Q:  A sample of 6400 Englishmen have a mean height of 67.85 inches
and a SD of 2.56 inches. While another sample of 1600 Australians
have a mean height of 68.55 inches and a SD of 2.52 inches.
 Do the data indicate that Australians are on the average taller than
Englishmen?
Ans: 
SD2 SD2
SE( x1 − x 2 ) = +
n1 n2

2.56 2 2.52 2
= + = 0.071
6400 1600
Here, n1 = 6400
n2 = 1600
SD1 = 2.56
SD2 = 2.52
SE( x − x ) = 0.071
1 2

Twice the SE( x − x ) = 0.141322


1 2

Observed difference is 68.55 – 67.85 = 0.7

Inference
Observed difference (0.7) is more than twice the
SE( x1 − x 2 ) = (0.14), hence significant.
The data indicate that Australians are on the average taller than
Englishmen.

Standard Error of the Difference Between Two Proportions


Q: Mortality from peritonitis among dogs treated with two types of sulfa
drugs is as under:

Treatment Death Survival Total


Sulfanilamide 50 50 100
Sulfathiazole 60 40 100

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Survival rate is 10% more in sulfanilamide. Is it significant?


P1q1 P2q 2
SE pˆ −p = +
n1 n2

Values (Decimal)
P1 = 0.5 q1 = 0.5 n1 = 100
P2 = 0.4 q2 = 0.6 n2 = 100
Values (Actual)
P1 = 50 q1 = 50 n1 = 100
P2 = 40 q2 = 60 n2 = 100
(You can apply any one decimal for actual)

50× 5040+×40
50 ×50 60× 60 = 7.0
SE pˆ SE = =
=
−p pˆ −p
+ = 7.0
100100 100100
50 × 50 40 × 60
=
Twice the SE pˆ −p = 14.0 + = 7.0
100 100
Observed difference: 50 – 40 = 10

Inference
Observed difference (10) is less than:
zz Twice the (14)
Hence not significant
More survival rate seen with first drug is only by chance.

X2 Test (Chi-square)
X = Normal distribution where x = 0 and SD = 1
X2 = Follow X2 distribution (Appendix 12)
This test is used:
—— To test the goodness of fit (i.e. difference between observed and

expected is significant or not).


—— To find association of attribute (dependent or not).

Q: A cancer screening test was carried out by a team of oncologists at


cancer hospital Mysore. Total of 300 people were screened for oral
cancer. The findings are:
—— Oral cancer plus were 100, under whom 20 were positive for

chewing tobacco

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200 people were without oral cancer, under whom 110 were
——

positive for chewing tobacco.


What is your interpretation?
Ans:
Chewing Not chewing Total
Oral cancer 20 (43.3) 80 (56.7)  100
No cancer 110 (86.7) 90 (113.3)  200
Total 130 170 300
Note: Expected values are in brackets (E). This is calculated by:

Row total × Column total


E =
Grand total
2 Σ(O − E)2
X =
E
(20 − 43.3)2 (80 − 56.6)2 (110 − 86.7)2 (90 − 113.3)2
=  +   +  +
43.3 56.6 86.7 113.3
= 12.54 +    9.67 + 6.26   + 4.79
= 33.26
X2 = 33.26
DF = (C – 1) (R – 1) = 1
C = Column
R = Row
Table value for DF = 1 at 0.05 is 3.84
at 0.01 is 6.64
at 0.001 is 10.83

Inference
X2 Calculated (33.26) is greater than
X2 Table value at DF = 1, P = 0.001
Hence highly significant
Oral cancer and chewing tobacco are dependent on each other.

Z-test
− x 2 SD define area under normal curve (Gaussian).
x 1and
It is possible to relate the distance between any observed value (x)
and the mean of curve (µ).

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Biostatistics for the Dissertation/Research 97

(x – µ) distance to the SD of that curve.


Thus, we get a standard normal deviate called “Z” (Appendix 13).
   x – µ x–µ
Z= or
SD SD/n
e.g. µ of height of population = 10˝
x of height of observed population = 20˝
SD of normal curve = 5˝
x – µ    20 – 10    10
  Z = = = = 2
       SD     5 5
i.e. x can be located at 2 SD distance from the center of curve.
Q: A sample of 6400 Englishmen have a mean height of 67.85 inches
and a SD of 2.56 inches; while another sample of 1600 Australians
have a mean height of 68.55 inches and a SD of 2.52 inches.
Do the Z-test for its significance.
It is Z-test where 2 means are compared.
x1 − x 2 67.85 − 68.55 0.7
Z = = =
SD2 SD2 2.56 2 2.52 2 0.0707
+ +
n n 6400 1600
= 9.9010
NH (Null Hypothesis) = x 1 ≡ x 2 ≡ 0
Calculated Z is more than 3, reject NH
It is highly significant.
Australians are taller than Englishmen.
Q: Mortality from peritonitis among dogs treated with two types of sulfa
drugs is as under:

Treatment Death Survival Total


Sulfanilamide 50 50 100
Sulfathiazole 60 40 100

Do the Z-test for the significance.


Ans:  It is Z-test where two proportions are compared.
Pˆ − p 50 − 40 10
Z = = = = 1.42
p1q1 p1q 2 50 × 50 40 × 60 7
+ +
n1 n2 100 100

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Here Z calculated is less than 2. Hence, not significant. Accept null


hypothesis. Survival is only by chance.
Note: Z-value above 2 significant (P = 0.05).
Z-value above 3 highly significant (P = 0.005)

‘t’ test
‘t’ is student t-test a pseudoname after British statistician William Sealy
Gosset (1876 to 1947)
Two types commonly used tests are:
(i) ‘t’ test for 2 sample mean (ii) Unpaired t-test

‘t’ Test for 2 Sample Mean


Q: The weight gained (in Pounds) of experimental animal fed on diet ‘A’
and diet ‘B’ are given:
Diet A—25, 32, 30, 34, 24, 14, 32, 24, 30, 31, 35, 25 (n = 12)
Diet B—44, 34, 22, 10, 47, 31, 40, 30, 32, 35, 18, 21, 35, 29, 22 (n = 15)
Test if the 2 diets differ significantly as regard to their effect on
increase in weight of experimental animals.
Here t-test for 2 sample mean is applied.
Diet A Diet B
  x1 ( x –− x ) ((xx –− x )2
(x x2 ((xx –− x ) ((xx –− x )2
25 –3 9 44 14 196
32 4 16 34 4 16
30 2 4 22 –8 64
34 6 36 10 –20 400
24 –4 16 47 17 289
14 –14 196 31 1 1
32 4 16 40 10 100
24 –4 16 30 0 0
30 2 4 32 2 4
31 3 9 35 5 25
35 7 49 18 –12 144
25 –3 9 21 –9 81
( x − x 1) = 28 380 35 5 25
29 –1 1
22 –8 64
( x − x 2) = 30 1410

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Biostatistics for the Dissertation/Research 99

( )
2
Σ( x 1 − x )2 Σ x2 − x
SD = SD =
n1 − 1 n2 − 1
380 1410
= = 5.87 = = 10.04
11 14
Now, pooled SD is to be calculated.

n1s12 + n 2s22
Pooled SD, S =
n1 + n 2 − 2
12(5.87)2 + 15(10.04)2 = 8.7
=
12 + 15 − 2

t-value is calculated by:


x1 − x 2 28 − 30 2
t= = = = 0.6135
1 1 1 1 3 .26
s + 8.7 +
nl n2 12 15

DF = n1 + n2 – 2 = 25
t table value DF = 25 P = 0.05 is 2.06 (Appendix 14)
t calculated value is 0.6135
t calculated is lesser than t table value at DF = 25 P = 0.05
Hence, not significant

Unpaired ‘t’ Test


Q: A drug given to 12 volunteers showed the following differences in
systolic BP

Volunteers 1 2 3 4 5 6 7 8 9 10 11 12
BP before 120 114 112 120 110 116 120 104 106 98 110 110
drug
BP after 125 115 114 125 118 120 119 110 109 98 110 108
drug

Can you conclude that the drug in general is accompanied by an


increase in systolic BP?
For this question, unpaired t-test is applied.

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Before After Difference (d) (d − d ) ( d − d )2


drug drug = x 1 – x2
(x1) (x2 )
120 125 5 2.42 5.8564
112 114 2 –0.58 0.3364
110 118 8 5.42 29.3764
120 119 –1 –3.58 12.8164
106 109 3 0.42 0.1764
110 110 0 –2.58 6.6564
110 108 –2 –4.58 20.9764
114 115 1 –1.58 2.4964
120 125 5 2.42 5.8564
116 120 4 1.42 2.0164
104 110 6 3.42 11.6964
98 98 0 2.58 6.6564
31
104.9068
31
d= = 2.5833
12
(d − d)2 104.9068
SD = S = = = 3.0882
n −1 12 − 1 d / s 2.5833 / 3.0882
t= =
Now t-test is applied n 12
d / s 2.5833 / 3.0882 2. 58
t= = = = 2.8980
n 12 0.8914
DF 2.=58 n – 1 = 12 – 1 = 11
= 2.8980
t 0.table
8914 value = 2.201, DF = 11, P = 0.05
t  calculated value = 2.8980 is greater than table value
Hence significant.
Drug has definite influence on BP.

CORRELATION

Pearson Product Moment Coefficient (r)


Relationship between two series of measurement is done.
e.g. Height and weight age and vital capacity, etc.
It can be found out by graph method or by formula.

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Biostatistics for the Dissertation/Research 101

It is expressed as:
zz Perfect positive
zz Partial positive

zz No correlation

zz Partial negative

zz Perfect negative

Values are between –1 to + 1


See the following graph for illustration:

A B C

Figs 8.12A to C  (A) Positive correlation; (B) No correlation; and


(C) Negative correlation

Learn (r) Calculation Through Problem Solving


Q: Find the value of r for the following:
X 48 52 60 45 65 72 80 50
Y 50 55 72 50 60 60 78 55
Ans:
x y (x – x–) (y – y–) (x – x–)2 (y – y–)2 (x – x–) (y – y–)
48 50 –11 –10 121 100 110
52 55 –7 –5 49 25 35
60 72 1 12 1 144 12
45 50 –14 –10 196 100 140
65 60 6 0 36 0 0
72 60 13 0 169 0 0
80 78 21 18 441 324 378
50 55 –9 –5 81 25 45
472 480 1094 718 720

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102 Synopsis, Dissertation and Research to PG Students

472
x= = 59
8
480
y= = 60
8
1 ( x − x )( y − y )
r=
n (SDx ) × (SD y )
1 (720) 90
= =
8 1094 718 126.62
×
7 7
= 0.7108
Ans: r = + 0.7108

Inference
There is positive correlation between X and Y.

Spearman Rank Correlation Test (Rho) (ρ)


It is a nonparametric test. It makes no assumption about the nature of
distribution. So, it is free of assumed parameters.
It is a measure of association of ranked data, i.e. substituted rank is
used in test.

Learn by Problem Solving


Q: Every year Dhanwantri Quiz is conducted at KIMS Hubballi by the
department of community medicine. In 2000, the Quiz was conducted
in June. In this Dhanwantri Quiz, there were 10 participants. Judges
were One Professor of Medicine and One Professor and Head,
Department of Community Medicine. The scores by these 2 judges
are as follows:
    Candidates
1 2 3 4 5 6 7 8 9 10
Judge 1 10 2 1 7 8 6 5 4 9 3
Judge 2 1 3 4 9 7 5 6 8 10 2
Can you find a common taste in their judgment?

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Biostatistics for the Dissertation/Research 103

Ans:
10 2 1 7 8 6 5 4 9 3
1 3 4 9 7 5 6 8 10 2
(d1) 9 –1 –3 –2 1 1 –1 –4 –1 1
difference
(d1)2 81 1 9 4 1 1 1 16 1 1
Total of (d1)2 = 116
6 Σ(d1 )2
Spearman )2s =correlation
6 Σ(d1rank 1− = Rho (ρ)
s = 1− n(n 2 − 1)
n(n − 12)
2

6 Σ(d1 ) 6 (116)
ρ s= = 1 − 6 (2116 ) == 1 −
= 1 − n(n −2 1) 10(10 2 − 1)
10(10 − 1)
6 (116) 696
= 1 − 696 2 = 1−
= = 1 − 10(10= 1−–1)0.7030 = 0.2970 = + 0.2970
990
990
696
= 1−
\ ρ is not high
990
\ Judges do not possess common taste.
They are biased.

WORKOUT THE FOLLOWING PROBLEMS

Biostatistics
Question 1: Draw a cumulative frequency curve (OGIVE) and point
out Q1 (25 percentile), Q2 (Median), Q3 ((75 percentile), 10th and 20th
percentile values.

X f
0–10 2
10–20 7
20–30 13
30–40 28
40–50 12
50–60 6
60–70 2

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104 Synopsis, Dissertation and Research to PG Students

Question 2: Construct a histogram and also a frequency polygon from


the following table:

Week of onset of illness Number of cases


1 6
2 7
3 12
4 15
5 10
6 5
7 2
8 1

Number of reported cases of influenza by week of onset at Sattur in 2010.


Question 3: Construct a multiple bar diagram from the following data:

Age group Sample population Census population


(year) (percentage) (percentage)
Below 1 5 4
1–4 19 17
5–14 24 21
15–44 39 40
45+ 11 11

Question 4: Construct a pie diagram for the following data:


Distribution of causes of childhood mortality in rural Dharwad Taluka
during 2009

Diarrheal diseases 28%


Malaria 7%
NNT 6%
ARI 20%
Measles 11%
Others 28%

Question 5: Construct a map diagram for the following data:


Eight serological positive for HIV were reported in Dharwad district
during May 2011 period

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Biostatistics for the Dissertation/Research 105

Yadwad village 3 cases


Kalyanpura extension (city) 1 case
Rayapura village 1 case
Hubballi town 1 case
Kalghatgi village 1 case
Old Hubli 1 case

Question 6: A simple random sample is always a good representative of


the population.
True or False ? Why ?
Question 7: Suppose you are interested in estimating the immunization
status with respect to polio of children aged 6 and 7 years in a large city.
Following proposals for selecting the samples are offered:
zz Children found upon enquiry at every tenth house in the city
zz Children drawn by lot from public school records of 6 and 7 years

olds
zz Family contacts to chickenpox

zz Family contacts to diphtheria cases

Discuss briefly your views with regard to each of these suggestions.


Question 8: Is the following statement justified?
In 1990, 10% of deaths in Manjushree Nagar, in a certain age group
were due to cancer. In 2010, such cancers accounted for 15% of deaths in
the same age group, in that area. Therefore, the rise of dying from cancer
has increased.
Question 9: In a simple random sample every element in the universe
has an equal chance of being chosen.
True or False ?
If False, state reason.
Question 10: Comment on the following stated table:

Industry A Industry B
Number of industrial fatalities per year 100 50
Average Number employed in the industry 10000 1000
Rate or risk of Industrial fatality/year 0.01 0.05
Question 11: Use table of random numbers to select a random sample
of 10 cases from the table below. Determine the proportion of male in
your sample.

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106 Synopsis, Dissertation and Research to PG Students

zz Why may your sample differ from the true proportion ?


zz Why in general would you expect a better estimate if the sample (n)
were larger ?
Case Sex Case Sex Case Sex Case Sex Case sex
No No No No No
01 M 11 M 21 M 31 F 41 M
02 M 12 M 22 M 32 F 42 F
03 F 13 M 23 F 33 M 43 M
04 M 14 F 24 M 34 F 44 M
05 F 15 M 25 M 35 M 45 F
06 M 16 F 26 F 36 M 46 M
07 M 17 F 27 M 37 F 47 M
08 F 18 M 28 F 38 M 48 F
09 M 19 F 29 M 39 F 49 F
10 M 20 M 30 M 40 M 50 M

Solutions to the Problems are Worked Out

Question 6 Answer
False: On an average, a simple random sample will provide an unbiased
estimate of the characteristics of the population and therefore, will be
representative of it. However, any one sample may have values that are
not typical.

Question 7 Answer
zz Children found upon inquiry at every 10th house in the city: This
method will result in the most “representative” sample of the
methods proposed; but it is the most time consuming and costly.
(every 10th house inquiry in systematic sample, which could lead
to bias if every 10th house is a corner house with a higher income
family). It may involve listing of all houses to draw a sample , call
backs, transportation, enumerators expense as well as visits to
houses without 6 and 7 year old children.

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Biostatistics for the Dissertation/Research 107

zz Children drawn by lot from public schools records of 6 and 7 years


olds: The sample cannot be representative of all children, primarily
because it will exclude children attending private and parochial
schools. In some cities, this group may be relatively large. If the survey
is extended to these children the sample representation would be
adequate even though a small number not attending school due to
physical or mental handicaps who are excluded. This method would
be much more practical than a house survey. It would probably be
necessary, however, to obtain the information from their parents of
the sample children by questionnaire.
zz Family contacts to chickenpox: The chief difficulty with this method
is selection due to differential reporting of chickenpox. Cases are
not likely to be reported unless there is a physician. Reported
cases, therefore, may be corrected children with medical care and
immunization. Also “only” children rarely would be included.
zz Family contacts to diphtheria case:
This proposal is much worse than (C). Major problems are:
—— The very small number of diphtheria cases today.

—— The almost certain inverse relation between the occurrence of

diphtheria and polio immunization. This would lead to a gross


underestimate of the true proportion immunized.

Question 8 Answer
No, it is not justified.
The percentage in the statement reflects only proportionate mortality
figures. It is possible that the number of deaths from cancer decreased
in 20 years. But that there was an even greater decrease in deaths from
other causes.
It is essential to compare probabilities of death or death rates in
order to make such statements.
Number of deaths during the year
Death rate =
Number of population exposed to risk of dying

Question 9 Answer
True: In a simple random sample, every element has an equal probability
of being selected.

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108 Synopsis, Dissertation and Research to PG Students

Question 10 Answer
Two groups cannot be compared as to risk of an event like accident.
Hereby simply comparing the number of events.
In the table, industry B has the higher risk of fatality 50/1000 or 0.05
compared with industry A where fatality is 100/10000 or 0.01.
More persons are employed in A and the number of industrial
fatalities also is higher in A.
This illustrates the common fallacy of the lack of denominator.
A denominator is needed to form an appropriate rate in order to
calculate risk.

Question 11 Answer
zz The sample proportion may differ from the true proportion because
of chance variation (It is called sampling error).
zz In general, the sample is more likely to be a good representative of
the population as the sample size increases; because there I greater
likelihood of selecting elements from all parts of the distribution.
Procedure for referring random table:
Arbitrarily pick a 2 digit in the column with closed eyes.
Beginning with the starting number, continue to sequentially select
every 2 digit numbers until 20 cases or 10 cases are selected.
Skip the number which is not included in the sequence 01 to 50.
Disregard the number if repeats. Keep record to avoid picking up a
number twice.
Sample selection can be in any direction: above downwards, from
left to right, from right to left or below upwards (as per your wish).

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9
CHAPTER Prevention of
Hospital Acquired
Infection

HIGH-RISK PROCEDURES
Following high-risk procedures need special attention:

Injections
zz Intact mucous membrane of health personnel at work
zz Aseptic precaution at injection
zz Decontamination of skin area
zz Disposal of syringe and needle as per guidelines.

Surgical Procedures
zz Operation theater (OT) disinfection (instrument, material,
equipment, gloves, etc.)
zz Surface disinfection after surgery
zz Material, linen, equipment after surgery are disinfected and disposed
zz Tissue/organ are incinerated or buried deep with lime or bleach.

Dressing of Wounds
zz Use of sterile instruments, material, lotion, creams
zz Disposal only after disinfection.

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110 Synopsis, Dissertation and Research to PG Students

Management of Delivery
zz Delivery of suspected or known HIV should be in a separated place
from the main area (since HIV patients need protection as they are
prone for infection)
zz Sterile material used must be decontaminated after use
zz Table top, floor need decontamination
zz Doctors attended, including pediatrician, should change to another
set of footwear, gown, etc. before handling other patients
zz Lactating women and newborn when attended, then also they
should change their set before attending others
zz Glove, waterproof apron, shoe, mask, protective eye cover are must
to the attending staff
zz Care at disposal of placenta—should be buried with bleaching
powder all round, bleaching powder spread on the floor of the pit
before putting placenta.

Investigative Procedure
zz Invasive like lumbar puncture, cut downs, tappings, aspirations,
biopsy, laparoscopy, endoscopy, cardiac catheterization,
bronchoscopy, intravenous pyelography, retrograde pyelography
are treated as surgical procedures
zz Noninvasive like Per Vaginal examination, Per rectal examination,
prostatic massage, intraocular pressure test, tracheal examination,
laryngeal examination, throat examination, echocardiography,
ultrasound, X-ray, CT scan may have breaks in mucous membrane.
Hence, sterile instruments are suggested. After use, they are to be
regarded as contaminated.

Laboratory Investigations
Laboratory technicians, doctors on duty, nurses in laboratory need
a day’s training to get awareness of the do’s and don’ts as well as
precautionary measure required.
zz Blood, tissue and blood contaminated material

—— Autoclaved/presterilized disposable needles

—— Syringes for collection

—— Disposable lancet for finger prick.

zz Body fluids, like CSF, pleural fluid, pericardial fluid, semen, vaginal

fluid

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Prevention of Hospital Acquired Infection 111

—— Autoclaved/presterilized disposable needless


—— Needles for collection.
zz Urine, sputum, bronchial washing, swabs
—— No instruments needed

—— If needed, presterilized disposable ones are used

—— At collection use gloves.

Dialysis
zz Proper disinfection, antisepsis needed
zz High level disinfectants are required.

DISINFECTION PROCEDURE
It is a process of destruction or removal of organisms capable of giving
rise to infection. It is always preferred only next to sterilization.
Instruments and equipment that come in contact with intact skin
but do not pierce should be disinfected between each patient contact.
Disinfection of skin and mucous membrane must be carried out
before use of any skin piercing instruments or equipment.
Autoclaving of re-useable material or disposable material is
advocated.
Hospital disinfection, OT disinfection are strongly advocated as per
the laid down procedure.
Disinfection policy for a hospital is required to prevent outbreak of
infections.
Universal precaution is advocated in case of HIV/AIDS infection, or
even for general hospital practice.

Methods of Sterilization and High Levels Disinfection


in Hospital
zz Heat
Moist:
—— Above 100°C

—— At 100°C

—— Below 100°C as advocated

Dry:
—— Hot air oven

zz Chemicals
zz Ionizing radiation
zz Filtration.

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112 Synopsis, Dissertation and Research to PG Students

Suggestion Dilutions
Table 9.1 illustrates dose of cone of disinfectants for hospital material
which are of two types viz. clean contaminated and grossly contaminated.

Table 9.1  Dilutions of disinfectants


Disinfectants Clean contaminated Grossly contaminated
Sodium hypochlorite 1 g/L 10 g/L
(1000 PPM) (10000 PPM)
Tr. of Iodine 2.5% 2.5%
Povidone iodine (PVI) 2.5% 2.5%
Cidex (2% glutaraldehyde) 2.0% 2.0%
Formalin 5.0% 10%
(2% formaldehyde) (4% formaldehyde)
Ethyl alcohol 70% 70%
Hydrogen peroxide 6% Not recommended

DISCARD AND DISPOSAL HOSPITAL WASTE


Table 9.2 shows treatment option for hospital waste disposal.

Table 9.2  Hospital waste disposal


Waste class category Waste description Treatment method
Human anatomical Human tissue, organs, waste Incineration
wastes blood, body body parts, body fluids, blood
fluids and blood products, items
saturated or dripping with
blood, body fluids contaminated
with blood and body fluids
removed during/after treatment,
surgery or autopsy or other
medical procedure
Microbiological Laboratory culture stocks or Incineration
wastes specimen of microorganisms
live or attenuated vaccine,
human or animal cell culture
used in research, infectious
agents from research wastes
from production of biological
dishes and devices used for
transfer of cultures
Contd...

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Prevention of Hospital Acquired Infection 113

Contd...
Waste class category Waste description Treatment method
Waste sharps Sharps, such as needles scalpel, Chemical disinfection
blades, etc., which include both autoclaving followed
used and unused by shredding
Discarded Wastes generated from Chemical disinfection
glasswares glasswares and glass equipment autoclaving followed
used by shredding

UNIVERSAL PRECAUTION
zz Appropriate barrier precaution to prevent skin mucous membrane
exposure.
—— Gloves

—— Masks

—— Protective eye wear

—— Facial shields

—— Gown/apron.

zz Hand and skin surface thorough wash.


—— This is to be repeated after glove removal.

zz Precaution to prevent injury by needle, scalpel, sharp.


zz Mouth pieces, resuscitation bags, other ventilation devices as
precaution to HIV transmission in emergency.
zz Refrain from work if skin lesions present or a weeping dermatitis is
present.
zz Pregnant health worker take greater care while attending to HIV
patients.
zz Always prefer disposables in health care.

HIV/AIDS CONTROL AND PREVENTION


Precaution for safe working practice recommended.
zz Suspected HIV, HIV +ve, all samples and donations must be handled
carefully to minimize exposure of skin and mucous membranes.
zz All laboratory procedures on suspected HIV/HIV +ve should done in

a separate room to have minimum interruption from outside.


zz Doctor/Paramedical should wear double gloves for hand protection

and wash their hands thoroughly before leaving.

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114 Synopsis, Dissertation and Research to PG Students

zz Surface and apparatus should be disinfected on every week and


without fail with a suitable disinfectant.
zz Sodium hypochlorite solution is used for cleaning work benches
specimen containers and gloves.
Clean contaminated   1 g/L
HIV suspected   5 g/L
Grossly contaminated 10 g/L
zz General safety measures like:
—— No eating, drinking, smoking, cosmetics application or mouth

pipetting.
—— Any break in skin out, puncture wound or skin eruption must be

kept covered, either with a waterproof dressing or rubber glove


or both.
—— Any needle prick, puncture wound (Appendix 15).

i. Is made to bleed freely under a running tap to washout any


infected material
ii. Immediate reporting for prophylactic treatment
- Local treatment for prick/wound
- Zidovudine drug prophylactic (monodrug)
- On 3rd day blood sample is sent by the institute to Poona
for HIV reaction test either to stop drug (if negative) or to
give proper course (if +ve)
—— Splash of blood, serum, plasma on face is equally serious. Eye

bath for eye splash, if nose, lips, mouth are involved, washing
with copious amounts of water. Immediate reporting for
prophylactic treatment is to be done.
—— If blood is splashed, the sample from the source is collected

and tested for HIV and further prophylactic treatment is to be


administered.
—— If a tube or a bag is leaked containing suspected specimen

during centrifugation, lid is closed for 30 minutes. Debris are


picked up with forceps by wearing glove. Rotor should be placed
in antiseptic solution overnight. Washing, disinfection and
drying are must before re-installing.
—— Appropriate training of risk staff and paramedicals is advocated.

—— Disposable equipment must not be re-used.

zz Disposal of needles, sharp instruments and nonusable equipment


to prevent accidental needle prick injury and infection from blood
and safe disposal of needles from blood collection facilities requires

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Prevention of Hospital Acquired Infection 115

special attention. Container for transport, decontamination with


sodium hypochlorite solution for 24 hours and then bagged for final
disposal is advocated.
zz Needles, sharp objects must be placed in tins or strong box.
zz All blood units found infected are to be disposed off by autoclaving
or heat treatment (60°C for 90 min) followed by either incineration or
burial. Under no circumstance blood should be thrown into sewers.

PROTECTION AGAINST SEVERE ACUTE


RESPIRATORY SYNDROME
A droplet infection by new corona virus which is highly contagious, with
high secondary attack rate and case fatality rate is an emerging infectious
disease bothering health science institutions. Severe Acute Respiratory
Syndrome (SARS) has been direct cause of death and disability among
all category of professionals in health sciences.
It can transmit in any season. Overcrowding precipitates spread.
Population density and population movement affect epidemic outbreak.
It is transmitted from person-to-person with aerosolized (exhaled)
droplets and bodily secretions from infected person. Similar to home
contacts, health science personnel are high-risk group.
Wearing efficient filter mask, goggle, apron, head cover and gloves
are specific protective devices.
Following types of mask are suggested:
zz A 71 mask (` 80.00) to paramedicals
zz N 95 mask (` 230.00) to attending health professionals

zz NBC mask (` 2000.00) to personnel directly involved in isolation

hospitals.
Hospital guidelines for control of SARS are given in Appendix 16.

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10
CHAPTER Computer
Technology in PG
Dissertation Work

INTRODUCTION
It has become indispensable in the field of medical research, for post-
graduate day-to-day work, including synopsis work, dissertation work,
publication work and even library reference through net.
One has to have the basic knowledge of computers for academic and
professional life. Knowledge of typing and documentation has become
good tool in scientific technology.
Computer technology has been key for any modern work, be it
official, professional, mathematical or documentary—is itself a great
achievement. Its contribution to health science cannot be understood.
Data storage and Power Point Presentation has made a remarkable
impact on the teaching and training fields especially for medical and
allied fields.
By 1970 key board and monitor to a large central computer got
replaced by PC (personal computer) making it more efficient and really
affordable.

PARTS OF COMPUTER
Central processing unit (CPU) is the main microchip that distribute
tasks to all parts of computer (Fig. 10.1).
Operational RAM (Random Access Memory) slots on motherboard,
also determines speed.
Data store is hard drive. Its size is in gigabytes.

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Computer Technology in PG Dissertation Work 117

Fig. 10.1  Parts of computer

Peripherals are USB storage device and keyboard and mice are input
devices.
To carry out data we have CD-ROM, DVD and USB.
To produce output we have monitor presently LCD that are not
bulky.
Printers and Scanners are devices that are allied with computer and
are indispensible.
All computer programs are softwares.
Operating systems are Windows, Mac and Linux.

Software for Sample Size Determination


Initially to understand and learn the basics of sample designing, one has
to do manually and later can to for computer software, manually PGs
have to do. Later they can go for computer software.

SOFTWARE FOR DATA ANALYSIS


Statistical analysis has become easy. However, basic understanding by
manual analysis of statistical sample and later to go for software for huge
data are more appropriate.

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118 Synopsis, Dissertation and Research to PG Students

Search/Edit Data
Data storage and data retrieval have fastened search and editing of data.

Software for Literature Search


Soft ware is also helpful for literature search.
All University of Health sciences in India have been insisting on
submission of dissertation through e-submission (electronic) and
CD-ROM.
Care in spell check is required. Correction in word processor is
advocated. Better avoid spell checker which often cannot identify words.
Bibliographic software is commonly in use nowadays.
Online submission of scientific communication is easy now.
Back ups are required. One can take ghost image help in emergencies.
It should be remembered that PGs shall use computer as tool, but
should not depend on it.

NETWORK/INTERNET
The network (Internet) has become a way of life in Medical Research.
Medical professionals are trying to find different ways of accessing the
net. The dialing connection made through standard modems over PSTN
(Public Switched Telephone Network) provides abysmal speeds ranging
from 14 Kbps to 56 Kbps. Large organizations prefer a range of 64 Kbps
to 2 Mbps.
The technology of Net effectively utilizes copper wire to transmit
data in DSL (Digital Subscriber Line), transmit voice and transmit a host
of bandwidth intensive multimedia applications.
Phone transmit voice signal in the analog made over copper
wires. This gets converted to digital information by the modem, which
demodulates the analog signal from phone to strings of 0s to 1s.
To make computer to understand and to accept.
By installing special equipment on net, direct transmission of digital
data is possible. Here user use both voice call facility and data through
computer at the same time (maximum bandwidth utilization).

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Computer Technology in PG Dissertation Work 119

Flavors of DSL that are available are


DSL (Digital Subscriber Line)
ADSL
HDSL
SDSL Proprietary and standard variants of DSL like
VDSL Asymmetric DSL, High DSL, etc.
RADSL
UDSL
DSL Lite
Types of networks are: LAN (Local Area Network), CAN ( Controller
Area Network), MAN (Metropolitan Area Network), WAN (Wide Area
Network) an Internet (Network of Network).

OPERATING SYSTEM
Many flavors are seen in operating systems. Common fashionable ones
are worth mentioning:
zz BeO

zz DOS

zz Linux

zz Mac OS

zz Netware

zz OS/2

zz Plan 9 from Bell Labs

zz UNIX

zz Windows 95

zz Windows 98

zz Windows Millenium

zz Windows 2000

zz Windows XP

zz Windows 2003

zz Windows Vista

zz Windows 2008

zz Windows 7

zz Windows 8.1

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11
CHAPTER Biostatistical Tests
for Dissertation
(Learning by Doing)

INTRODUCTION
Following are common steps which are required to be followed for
developing appropriate statistical tests for a dissertation/research data:
Application of statistical tests on dissertation tables and statistical
inference are understood through this chapter.
It helps to develop your discussion chapter on your observation chapter
zz First ascertain whether your data is parametric or nonparametric.

zz Second ascertain your data is small sample or large sample.

zz Accordingly apply relevant statistical test, just replacing your data in

the formula cited in illustration.


zz When you arrive at your result, infer the significance of statistical

test done.
zz Your dissertation will have a better score over others.

STANDARD ERROR OF THE DIFFERENCE


BETWEEN TWO MEANS

Problem 1: Data on Height


Standard Error of the Difference between Two Means
Following is the data collected during a survey:

Number Mean Height (inches) SD


Englishmen 6400 67.85 2.56
Australians 1600 68.55 2.52

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Biostatistical Tests for Dissertation (Learning by Doing) 121

There is a difference of 0.7 inches in the mean. Is this significant?


n1 = 6400 SD1 = 2.56
n2 = 1600 SD2 = 2.52

SD12 SD22
SE x1 −x 2 = +
nl n2

2.56 2 2.52 2
SE x1 −x 2 = 6400 + 1600

Twice the SE x −x = 0.141322


1 2

Actual difference 0.7 inches is greater than twice the SE x −x


1 2
(0.141322); hence it is significant. It is true that Australians are taller and
it is not by chance.

Problem 2: Data on Anabolic Steroids


Standard Error of the Difference between Two Means
When we have encountered with comparing means of two groups, we
use SE x −x , which considers standard deviations and means of two
1 2
samples.

SD12 SD22
SE x1 −x 2 =  +
nl n2

Effect of anabolic steroids in weight gain


No Mean weight gained SD of weight
Study group 50 3.7 kg 21.2
Control group 50 3.1 kg 9.0

Let us determine whether the difference in weight gain between


study group and control group is significant. Applying the formula for
the SE of difference between two means.

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122 Synopsis, Dissertation and Research to PG Students

SD12 SD22
SE x1 −x 2 = +
nl n2

21.22 9.02
= +
50 50
= 8.98 + 1.62

= 10.6088 = 3.257
Actual difference between two means = 3.7–3.1 = 0.6.
SE x1 −x 2 = 3.25
Twice the SE x −x = 6.51
1 2

Actual difference 0.6 is less than twice the SE of the difference


between two means, hence not significant or anabolic steroids did not
affect the weight gain in the study group.

STANDARD ERROR OF THE DIFFERENCE BETWEEN


TWO PROPORTION (SEP^ – P)

Problem 1: Data on Poisoning


Standard Error of the Difference between Two Proportion SEP–P
^

A study on arsenic poisoning was conducted during 2002 (2 year follow-


up study) where following observation was made.

Arsenic type Deaths Survival Total


Paris green 66 48 114
White arsenic 148 161 309

First let us find % of survival


In paris green, it is 42.1%
In white arsenic,SS..it
E
E..is
p−
p − 52.1%
p
p

p
p11q
q11 + p
p1q
q1
SE^p – p = + 1 1
n
n ll n
n 22
42..11 ×
42 × 57 52..11 ×
57..99 + 52 × 47
47..99
= +
114
114 309
309
= 5.427

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Biostatistical Tests for Dissertation (Learning by Doing) 123

Twice SE^p – p = 10.854


Observed difference (52.1 – 42.1 = 10) is less than twice SE^p – p (10.854).
Hence, not significant and there is no strong evidence of any
difference between types of arsenic in survival rate.

Problem 2: Data on BCG Vaccination


SE of the Difference between Two Proportions
When we are encountered with comparing the events which are
proportions, we calculate SE of the difference between two proportions,
which considers proportion and SD.
p1q1 p2q 2
SE^p – p = +
n1 n2

 ccurrence of TB among BCG-vaccinated group and among


O
nonvaccinated group
n TB developed Disease rate
BCG vaccinated 2500 22 0.88%
BCG nonvaccinated 3000 90 3.0%

BCG vaccinated group p = 0.88 q = 99.12 n = 2500
BCG nonvaccinated group p = 3.0 q = 97.0 n = 3000

p1q1 p2q 2
SE^p – p = +
n1 n2
0.88 × 99.12 3 × 97
0.88 × 99.12+ 3 × 97
2500 +
× 99.12 3000
3 × 97
= 0.882500 + 3000
2500 3000
0.035 + 0.097
= 0.035 + 0.097
0.035 + 0.097
= 0.1319 = 0.363
0.1319
Twice the SE^p – p =0.0.7263
1319
Observed difference = 3.0 – 0.88 = 2.12
Observed difference (2.12) is more than twice the SE of the difference
(0.72). Hence, significant in the difference is noted.

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124 Synopsis, Dissertation and Research to PG Students

BCG has a role in showing less number of TB cases in the study


group.

CHI-SQUARE TEST (X2)

Problem 1: Data on Sex Ratio at Birth


Chi-square Test (x2)
The ratio of male to female birth in nature is 1:1. One of the survey
conducted by III year nursing students in Lucknow, showed the
proportion as 52:48 (52 Males are born for every 48 females). Could this
difference be due to chance?
Following are the four steps:
1. First: Let us prepare a contingent table.

Natural Lucknow Total


Male 50 52 102
Female 50 48 98
100 100 200

2. Second: Let us find expected value.


Male birth 102 for 200, for 100 it is
102/200 × 100 = 51, etc.

Natural Lucknow Total


Male 50(51) 52(51) 102
Female 50(49) 48(49) 98
100 100 200

Σ(O − E)2
3. Third: Apply X2 test by using formula X2 =
Where O = Observed value E
E = Expected value (calculated)
Σ(O − E)2
=
E
(50 − 51)2 (52 − 51)2 (50 − 49)2 (48 − 49)2
= + + +
51 51 49 49
= 0.79 = 0.08

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Biostatistical Tests for Dissertation (Learning by Doing) 125

4. Fourth: Find out degree of freedom by


(c – 1) (r – 1)
where c = column
r = row
Here (2 – 1) (2 – 1) = 1
DF = 1
5. Fifth: Find out table value of X2 for DF = 1 at P=0.05
(P = Probability)
This is 3.84
2
6. Sixth: Inference drawn, i.e. at x cal < x 2r at DF = 1, P = 0.05
that means x calculated (0.08) is less than x2 table value, at DF = 1
2

and at P = 0.05.
∴ Not significant
Statistical inference, the difference is only by chance.

Problem 2: Antibiotic in Infection


Chi-square test
Surgery and pharmacology departments jointly took up a study to
find out efficiency of neomycin in preventing staphylococcal infection
during first two weeks of burns.
Result
1. Infection developed in 18 out of 30 patients whose burns were
dressed with penicillin cream.
2. Infection developed in 5 out of 33 patients whose burns were dressed
with penicillin and neomycin cream.
What conclusion will you draw from this?
Ans: Infection
Dressing + – Total
Pencillin 18 (10.9) 12 (19.0) 30
Pencillin + Neomycin 5 (12.0) 28 (20.0) 33
23 40 63
X2= 14.49  DF = 1  P = 0.001 significant. Better result is seen with
combination of neomycin with penicillin.

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126 Synopsis, Dissertation and Research to PG Students

STUDENT T-TEST
Problem 1: Data on Birth Weight on Newborns
To Test the Difference Between Sample Mean and Population Mean
Birth weight of 8 newborn infants, in kgs were recorded which are
as under:
Infant number 1 2 3 4 5 6 7 8
Birth weight (kg) 3.4 2.1 2.4 2.8 3.0 1.9 2.6 2.2
Available population mean for newborn birth weight is 2.5 kg. Can
you assume population mean for birth weight in the study group?
x (x – –x) (x – –x)2
3.4 0.85 0.7225
2.1 -0.45 0.2025
2.4 -0.15 0.0225
2.8 0.25 0.0625
3.0 0.45 0.2025
1.9 –0.65 0.4225
2.6 0.05 0.0025
2.2 0.35 0.1225
20.4 ÷ 8 1.7600
–x = 2.55
Σ( x − x 2 )
Sample SD = S =
n −1

=
1.7600
7
= 0.5014

   µ = 2.50
–x = 2.55

x −µ 2.55 − 2.5
t = =
S / n 0.5014 / 8
= 0.1772
DF = n –1 = 7

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Biostatistical Tests for Dissertation (Learning by Doing) 127

‘t’ Table value with DF 7, p 0.05 is 2.365. ‘t’ Calculated is less than table
value.
Hence, accept NH. It is only by chance.

Problem 2: Data on PEFR on Working Environment


Student t-test
The peak expiratory flow rate (PEFR) in L/min of workers of a textile
industry who are in weaving section and in establishment section, both
have over 8 years of exposure; are given as under:
Exposed to weaving environment subjects:
Subject-8 hour/day for 8 years

Number 1 2 3 4 5 6 7 8 9 10 11 12
PEFR
(L/min) 425 432 430 434 424 414 432 424 430 431 435 425

Exposed to establishment environment subjects:


Subject-8 hr/day for 8 years

Number 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
PEFR
(L/min) 444, 434, 422, 410, 447, 431, 440, 430, 432, 435, 418, 421, 435, 429, 422

Can you conclude that the working environment in general is


accompanied by an increase in PEFR?
Test if the two environment differ significantly as regard to their
effect on increase of PEFR of industrial workers.
To Test for the Difference between Two Samples
x1 − x 2
where t =
1 1
S +
n1 n 2
_
x1 and x2 are means of two samples.
S = Pooled SD which is found out by
n1S12 + n 2S22
=
n1 + n 2−2
Σ( x 1 − x )2
S21 = Variance of I sample =
n1 − 1

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128 Synopsis, Dissertation and Research to PG Students

Σ( x 2 − x )2
S22 = Variance of I sample =
n2 − 1
n1 and n2 are sample sizes.
DF will be n1 + n2 – 2.
Ans: ‘t’ test is done to test the difference between two sample mean.
Sample A (x1––x) (x1––x)2 Sample B (x2––x) (x2––x)2
(x1) (x2)

425 –3 9 444 14 196


432 4 16 434 4 16
430 2 4 422 –8 64
434 6 36 410 –20 400
424 –4 16 447 17 289
414 –14 196 431 1 1
432 +4 16 440 10 100
424 –4 16 430 0 0
430 2 4 432 2 4
431 3 9 435 5 25
435 7 49 418 –12 144
425 –3 9 421 –9 81
435 5 25
5136 ÷ 12 380 429 –1 1
–x1 = 428 422 –8 64
                                   6450 ÷ 15        1410
–x2 = 430
Σ( x 1 − x )2
S21 Sample SD2 ⇒ Variance =
n1 − 1
= 380/11 = 34.5454
Σ( x 2 − x )2
S22 Sample SD2 ⇒ Variance =
n2 − 1
= 1410/14 = 100.71
n1S12 + n 2S22
Pooled SD = (S) =
n1 + n 2 − 2
= 12 (34.54) + 15 (100.71)/12+15-2
= 8.78
x1 − x 2
t = = 428 – 430 = 2
1 1
S +
n1 n 2

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Biostatistical Tests for Dissertation (Learning by Doing) 129

2
t = = 0.5875
1 1
8.78 +
12 15
    DF = n1 + n2 – 2 = 25
‘t’ Table value for DF = 25 P = 0.05 is 2.060
‘t’ Calculated is less than table value for DF 25 P = 0.05 not significant.
Accept NH.
Hence, working environment in general I not accompanied by an
increase in PEFR.

Problem 3: Data on Normal Population


Student t-test
‘t’ Test for correlation coefficient
r n−2
t = where
1 − r2
r = Correlation coefficient
DF = n – 2
A random sample of 27 pairs of observations from a normal
population gave the value of correlation coefficient(r) 0.6 (Pearson).
Test the significance of the value of r (Pearson correlation coefficient).
Ans: Here t-test for correlation coefficient is done by applying formula
r n−2
t =
1 − r2
0.6 27 − 2 0.6(5)
= =
1 − (0.6) 2
0.64
3
= = 3.75
0.8
DF = n – 2 = 25
‘t’ Table value = 2.060 DF = 25 P = 0.05
‘t’ calculated value is more than Table value at DF = 25 P = 0.05
Hence significant.
Pearson correlation coefficient (r) = 0.6 by the study is found
statistically significant.

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130 Synopsis, Dissertation and Research to PG Students

Problem 4: Data on Drug Influence on Breast Milk Yield


Student t-test
A drug was given to 12 lactating mothers showed the following difference
in the yield of breast milk.

Volunteers
1 2 3 4 5 6 7 8 9 10 11 12

Milk yield before drug in mL.


420 412 410 420 406 410 410 414 420 416 404 398

Milk yield after drug in mL.


425 414 418 419 409 410 408 415 425 420 410 398

Check any relation between drug and yield of the breast milk.
‘t’ Test for Paired Observations
Take the differences between the data of the pairs directly. If there is no
difference, it is ‘zero’, if it is more it is ‘positive’ and if less it is ‘negative’.
d
t = , where
S/ n

d = Average of the differences between paired
observations.
Σ(d1 − d)2
n −1
Steps followed are:
a. Difference under each category (pair) is noted vide reference made
above.

b. Mean of these difference is found out (d).

c. NH is set d = 0.
d. Sample SD is found where n is number of pairs of observation.
e. Applying ‘t’ test formula.
f. Statistical inference, with DF = n–1.
Ans: For paired observations ‘t’ test for paired test is done.
Data is retabulated to facilitate the calculation of mean d and s (SD).

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Biostatistical Tests for Dissertation (Learning by Doing) 131

Before After Difference


drug drug x1 – x2
– –
x1 x2 (d) (d ) (d 2)
420 425 5 2.42 5.8564
412 414 2 –0.58 0.3364
410 418 8 5.42 29.3764
420 419 –1 –3.58 12.8164
406 409 3 0.42 0.1764
410 410 0 –2.58 6.6564
410 408 –2 –4.58 20.9764
414 415 1 –1.58 2.4964
420 425 5 2.42 5.8564
416 420 4 1.42 2.0164
404 410 6 3.42 11.6964
98 98 0 –2.58 6.6564
31 104.97 Σd
2
( )
d = 2.5833 = mean d
S/ n
SD of sample = (S) = Σ(d − d )
2

n −1
104.9068
= = 3.089
11
d
t =
S/ n

2.5833 2.58
= =
3.0882 / 12 0.8914
= 2.8898
DF = n – 1 = 11
‘t’ Table value        DF = 11 and P = 0.05 is 2.201
‘t’ calculated is more than t table value at DF = 11, P = 0.05
Hence reject NH.
It is significant.
Drug has definite influence on the yield of breast milk.

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132 Synopsis, Dissertation and Research to PG Students

Problem 5: Data on Benefit of Sodium Bicarbonate on


Anesthesia
SD and Student t-Test
Inferences on Studies in Anesthesia
Benefit of NaHCO3 in Epidural Anesthesia
A. A study was conducted to know additional benefit of NaHCO3 with
epidural anesthesia.
Following are the time (in hours) with epidural anesthesia agents in 2
different study groups.
Experiment A:
Lignocaine + adrenaline
(hrs) 6.5, 8, 10, 8.5, 5, 8, 10, 8, 10, 6.5.
n = 10
Experiment B:
Lignocaine + adrenaline + NaHCO3
(hrs) 5.5, 5.5, 4, 4, 3.5, 4, 4.5, 4.5, 4, 3.5.
n = 10
Do the addition of NaHCO3 is of any significant value in epidural
anesthesia?
Approach to Problem
zz Small sample test, ‘t’ Test is to be applied.

zz Required mean, SD of 2 experimental values and combined SD

(pooled SD) of both are required.


Experiment B values

x (x–) (x–)2
5.5 1.2 1.44
5.5 1.2 1.44
x − mean x
4.0 –0.3 0.09 SD1 =
4.0 –0.3 0.09 n −1
3.5 –0.8 0.64 4.60
4.0 –0.3 0.09 = 9
4.5 0.2 0.04
4.5 0.2 0.04 = 0.71
4.0 –0.3 0.09
3.5 –0.8 0.64
43.0 4.60
Mean = 4.3

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Biostatistical Tests for Dissertation (Learning by Doing) 133

Experiment A values:

x (x–) (x–)2
6.5 –1.6 2.56
x − mean x
8.0 –0.1 0.01 SD1==
10.0 1.9 2.61 n −1
8.5 0.4 0.16 25.70
5.0 –3.1 9.61 =
9
8.0 –0.1 0.01
10.0 1.9 2.61 = 1.69
8.0 –0.1 0.01
10.0 1.9 3.61
6.5 –1.6 2.56
80.5 25.75
80.5 80.5
x = or x = 8.1 = 8.05 OR
= 8.05 OR
10 10
Pooled SD of Experiment A and B values
n1S12 + n 2S22
S =
n1 + n 2 − 2

= (10 × 0.71)2 + (10 × 1.62)2 = 1.26


10 + 10 − 2
t-Test application (for difference between 2 sample means)
x1 − x 2
t =
1 1
S +
n1 n 2
8.1 − 4.3
=
1 1
1.26 +
10 10
3.8
= = 6.74
0.5635
t calculated is greater than ‘t’ table value at DF 18 and at p =0.001, hence
significant.

Inference
There is definite significant relationship between onset time and agent
used in experiment B. It is not by chance.

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134 Synopsis, Dissertation and Research to PG Students

There is an established role of NaHCO3 with epidural anesthetic


agent.

Z TEST

Problem 1: Data on Height of Two Races


Z Test
To test the difference between two sample means in large samples.
A sample of 6400 Englishmen have a mean height of 67.85 inches
and a SD of 2.56 inches; while another sample of 1600 Australians have a
mean height of 68.55 inches and a SD of 2.52 inches. Do the data indicate
the Australians are on the average taller than Englishmen?
Test with SE of difference between two means and Z test.
Ans:
n1 = 6400
n2 = 1600
s1 = 2.56 (SD of I Sample)
s2 = 2.52 (SD of II Sample)
s
s2112  + s
s222
SE x1 − x 2 =
n1 + n 2
2.562 2.52 2
= +
6400 1600
= 0.071
Twice the SE x1 − x 2 = 0.1413
Observed difference = 68.55 – 67.85 = 0.7
Observed difference (0.7) is more than twice SE x1 − x 2 (0.14). Hence
significant.

Problem 2: Data on Height of Two Races


Z Test Application Where Two Means are Compared
x1 − x 2
Z =
SD12 + SD22
n1 + n 2
= 67.85 – 68.55 = 9.9

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Biostatistical Tests for Dissertation (Learning by Doing) 135

2.562 2.522
= +
6400 1600
NH = –x1 – –x2 is rejected since Z calculated is above 3.0 is significant
at P = 0.005.
Australians are taller than Englishmen.

Problem 3: Data on Smoking Habit Among Professionals

Z test
To test the difference between sample proportion and population
proportion in large sample
Among 2000 medicos, 200 were selected for a survey. Among these
200, 10 were smokers. The percentage of smokers in the population of
medical student community is available as 8 percent. Is this significantly
different from universal figure?
Ans:  Here attributes are qualitative phenomenon (or proportion).
  Z test for statistical test when two proportions are compared is used.
p̂ − p 5−8
=
pq 5 × 95
n 200
= 2.00
Z calculated is 2 and is significant at p = 0.05. Smoking among
medicos is significantly different from universe.
Note: Inference on Z test
Below 1.96 – Not significant
Above 1.96 – Significant at 0.05
Above 3 – Highly significant p = 0.005.

Problem 4: Data on Effect of Sulfa on Peritonitis

Z test
To test the difference between two sample proportions in large sample
Mortality from peritonitis among dogs treated with two types of sulfa
drug is as follows:

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136 Synopsis, Dissertation and Research to PG Students

Mortality from peritonitis among dogs treated with two


types of sulfa drugs
Treatment Death Survival Total
Sulfanilamide 50 50 100
Sulfathiazole 60 40 100
Apply large sample test.
Ans: Z test for proportion is applied.
p̂ − p
Z =
p1q1 p2q 2
+
n1 n2

5.50 − 0.60
=
0.5 × 0.5 0.6 × 0.4
+
100 100
= 1.43
Z calculated is less than 2 and is not significant. The inference is
more survival in sulfanilamide seen is only by chance.

PEARSON CORRELATION (r)

Problem 1: Data Correlation


r = Pearson Correlation
X = 4, 5, 6, 4, 6, 7, 8, 5    Y =  5, 5, 7, 5, 6, 6, 7, 5

III Method
x y (x–) (x–)2 (y–) (y–)2 (x–) (y–)
4 5 –1.6 2.56 –0.7 0.49 1.12
5 5 –0.6 0.36 –0.7 0.49 0.42
6 7 0.4 0.16 1.3 1.69 0.52
4 5 –1.6 2.56 –0.7 0.49 1.12
6 6 0.4 0.16 0.3 0.09 0.12
7 6 1.4 1.96 0.3 0.09 0.42
8 7 2.4 5.76 1.3 1.69 3.12
5 5 –0.6 0.36 –0.7 0.49 0.42
45 46 ...... 13.88 ...... 5.52 7.26

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Biostatistical Tests for Dissertation (Learning by Doing) 137

45 46 45 46
Mean x = = 5.625  or  5.6 Mean y = = 5.75  or  5.7
8 8 8 8
1 1
Σ( x − x )( y − y ) (7.26)
r = n = 8
ssx ⋅ssy 13.88 5.52
×
7 7
0.9075 0.9075
= = = 0.7319
(1.408) × (0.88) 1.24

Problem 2: Data on Age in Intrathecal Pethidine Block


Correlation Coefficient
Block with Intrathecal Pethidine
In a routine hospital auditing, it was observed that old age people take
much time for showing evidence of blockage with intrathecal pethidine.
Since it was time factor for coverage of larger sector awaiting for surgery,
suggestion was made to take a sample study to find out the relation of
age and duration of block with intrathecal pethidine.
Ten random patients were selected for the study.

Age and duration of anesthetics bleed among the study


group
No Code of patient Age (years) Duration of block (Minutes)
1 7 43 55
2 17 41 60
3 27 25 40
4 37 27 50
5 47 40 55
6 57 37 50
7 67 60 60
8 77 39 35
9 87 43 60
10 97 29 40

Check whether there is any correlation between age and duration


of block.

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138 Synopsis, Dissertation and Research to PG Students

Approach to the Problem

x y (x–) (y–) (x–)2 (y–)2 (x–) (y–)


43 55 4.6 4.5 21.16 20.25 20.7
41 60 2.6 9.5 6.76 90.25 24.7
25 40 –13.4 –10.5 179.56 110.25 140.7
27 50 –11.4 –0.5 129.96 0.25 5.7
40 55 1.6 4.5 2.56 20.25 7.2
37 50 –1.4 –0.5 1.96 0.25 0.7
60 60 21.6 9.5 466.56 90.25 205.2
39 35 –0.6 –15.5 0.36 240.25 9.3
43 60 4.6 9.5 32.16 90.25 43.7
29 40 –9.4 –10.5 88.36 110.25 98.7
384 505 ..... ..... 879.4 772.5 556.6
x– = 38.4 y– = 50.5
1 Σ( x − x )( y − y ) 1 556.6
r = =
n (s sxx ) × (ssy ) 10 879.4 772.5

9 9
55.66 55.66
= = = 0.6045
(9.9)(9.3) 92.07
There is +ve correlation.
t Test for above (r) is done:
r n−2 0.6045 10 − 2
t = =
1 − r2 1 − 0.60452
1.7098 1.7098
= =
1 − 0.3654 0.7966
t = 2.146
DF = 8 p = 0.05 Not significant

Inference
There is +ve correlation by Pearson correlation. But when tested with
t for this correlation it was not found significant at critical probability.
Though apparently there seems to be association between age of
patient and duration of block with intrathecal pethidine, this is not
statistically significant indicating that age do not influence the duration
of intrathecal blockage by pethidine.

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Biostatistical Tests for Dissertation (Learning by Doing) 139

SPEARMAN RANK CORRELATION

Problem 1: Data on Birth Weight Ranking

Spearman Rank Correlation


Original formula given by Spearman is R = Rank order correlation
6 Σd12
= 1 −
n(n 2 − 1)
Let us consider an outcome of recording of birth weight and weight gain
of 10 kids, who are given ranking for their birth weight and weight gain.
2
Birth weight (G) Rank Weight gain (kg) Rank d1 d 
1

2400 8 6.2 6 2 4
2600 6 7.1 3 3 9
2800 9 6.8 4 5 25
3000 5 10.3 1 4 16
3200 3 7.3 2 1 1
3400 10 5.3 9 1 1
3600 1 6.7 5 –4 16
3800 2 6.1 7 –5 25
4000 4 5.8 8 –4 16
4200 7 4.9 10 –3 9
122
Birth weight is given ranking one to 10 so also weight gain from one
to 10. The difference in ranking of the same kid is noted under d1 and its
square value in d 21.
Spearman Rank correlation Rho (ρ) is calculated by
6 Σd12
ρ = 1 −
n(n 2 − 1)
6(122) 732
= 1 − = 1−
10(102 − 1) 10(100 − 1)
732
= 1 −  = 1 – 0.7393 = 0.2607
990
This evidently shows that there is not much correlation between
birth weight ranking and weight gain ranking.

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Ch-11.indd 140 09-10-2015 16:59:58
Appendices
I
APPENDIX

Lesson Plan
Teacher : Dr GNP Date : Jan 2001
Class : MBBS Ph III Part II Time : 30 Min
Strength : 43 Subject : Community med.
Topic : Fundamentals of urinary
tract infection

OBJECTIVE (GENERAL)
At the end of the session, the learner should be able to describe the
fundamental of urinary tract infection.

SPECIFIC LEARNING OBJECTIVES


At the end of 30 minutes, learner should be able to
zz Define UTI
zz Describe clinical features and type of UTI

zz List common bacteria causing UTI

zz Describe normal defense mechanisms and predisposing factors of

UTI
zz Explain pathogenesis of UTI

zz Discuss the epidemiology of UTI

SET INDUCTION
Emphasis on common nature of UTI

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142 Synopsis, Dissertation and Research to PG Students

Item Content Method, Media


1. It is defined as more Narration,
than 100,000 organisms Chalkboard
per mL in a midstream
sample of urine
2. Upper UTI a. Acute pyelonephritis Display, explanation
b. Chronic pyelonephritis
  Lower UTI a. Cystitis, Urethritis OHP
b. Prostatitis, epididymitis
3. Gram negative bacteria E. coli, Proteus sp Derivation
klebsiella sp
  Gram positive cocci Staphylococcus Chalkboard
saprophyticus
Streptococcus faecalis
4. Anatomical factors Short urethra, proximity of Display discussion
anus to urethra
  Biological factors Vaginal colonization, OHP
urothelial susceptiability
5. Ascending infections/ Explain
Descending infections (Hematogenous)
Lymphatic spread OHP
6. Female Prevalence increases with Narrate
age
 Males First year of life: After Narrate chalkboard
60 years of life
Duration : 6 Items with each 5 minutes
Evaluation short answer questions are used.
Follow-up :
Assignment :
Assignment given: Find out antimicrobial sensitivities of common bacteria causing UTI
at KIMS hospital, Hubballi.

Signature : Sd/-
Designation : Professor and Head of the
Department of Preventive and
Social Medicine
Karnataka Institute of Medical
Sciences, Hubballi
Study material :
Dr GN Prabhakara : Four

Appendices.indd 142 09-10-2015 17:01:08


II
APPENDIX

Library Reference Record


(Annotated Bibliography)
If Journal/Periodical
Author :
Title :
Volume :
Number :
Year :
Page :
Abstract :
If Text
Author :
Title :
Publisher :
City :
Year :
Abstract :

Appendices.indd 143 09-10-2015 17:01:08


III
APPENDIX

Plan for Dissertation Work


(From the Date of Admission)
PHASE I
zz Topic selection
zz Review of literature
zz Preparation of proforma/structured

questionnaire First 6 months


zz Clearance from college level ethical (Six Months)
committee
zz Submission of synopsis of dissertation

PHASE II
zz Pilot study
zz Dummy table preparation 7 to 18 months
zz Data collection/clinical trial (One year)
zz Field study/experiment

PHASE III
zz Data analysis
zz Data discussion 19 to 24 months
zz Write up completion (Six months)
zz Ready for submission

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IV
APPENDIX

The Hippocratic Oath


“I swear by Apollo the Physician, by Aesculapius, by Hygieia, by Panacea,
and by all the gods and goddesses, making them my witnesses, that I
will carry out according to my ability and judgment, this oath and this
indenture. To hold my teacher in this art equal to my own parents; to
make him partner in my livelihood; when he is in need of money to share
mine with him; to consider his family as my own brothers, and to teach
them this art, if they want to learn it, without fee or indenture; to impart
precept, oral instruction, and all other instruction to my own sons, the
sons of my teacher, and to pupils who have taken the physicians. Oath,
but to nobody else. I will use treatment to help the sick according to my
ability and judgment, but never with a view to injury and wrongdoing.
Neither will I administer a poison to anybody when asked to do so, nor
will I suggest such a course. Similarly, I will not give to a woman a pessary
to cause abortion. But I will keep pure and holy both my life and my art.
I will not use the knife, not even, verily, on sufferers from stone, but I
will give place to such as are craftsmen therein. Into whatsoever houses
I enter, I will enter to help the sick, and I will abstain from all intentional
wrongdoing and harm, especially from abusing the bodies of man or
woman, bond or free. And whatsoever I shall see or hear in the course of
my profession, as well as outside my profession in my intercourse with
men, if it be what should not be published abroad, I will never divulge,
holding such things to be holy secrets. Now if I carry out this oath, and
break it not, may I gain for ever reputation among all men for my life and
for my art; but if I transgress it and forswear myself, may the opposite
befall me.

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V
APPENDIX

Declaration of Helsinki
Recommendations guiding physicians in biomedical research involving
human subjects.

INTRODUCTION
It is the mission of the physician to safeguard the health of the people.
His/her knowledge and conscience are dedicated to the fulfillment of
this mission.
The declaration of Geneva of the World Medical Association binds
the physician with the words, “The health of my patient will be my first
consideration” and the International Code of Medical Ethics declares
that “A physician shall not only in the patient’s interest when providing
medical care which might have the effect of weakening the physical and
mental condition of the patient”.
The purpose of biomedical research involving human subject must
be to improve diagnostic, therapeutic and prophylactic procedures and
the understanding of the etiology and pathogenesis of disease.
In current medical practice most diagnostic, therapeutic or
prophylactic procedures involve hazards. This applies especially to
biomedical research.
Medical progress is based on research which ultimately must rest in
part on experimentation involving human subjects.
In the field of biomedical research a fundamental distinction must
be recognized between medical research in which the aim is essentially
diagnostic or therapeutic for a patient and medical research, the
essential object of which is purely scientific and without implying direct
diagnostic or therapeutic value to the person subjected to the research.

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Appendices 147

Special caution must be exercised in the conduct of research which


may affect the environment, and the welfare of animals used for research
must be respected.
Because it is essential that the results of laboratory experiments be
applied to human beings to further scientific knowledge and to help
suffering humanity, the World Medical Association has prepared the
following recommendations as a guide to every physician in biomedical
research involving human subjects. They should be kept under review
in the future. It must be stressed that the standards as drafted are only a
guide to physicians all over the world. Physicians are not relieved from
criminal, civil and ethical responsibilities under the laws of their own
countries.

Basic Principles
zz Biomedical research involving human subjects must conform to
generally accepted scientific principles and should be based on
adequately performed laboratory and animal experimentation and
on a thorough knowledge of the scientific literature.
zz The design and performance of each experimental procedure
involving human subjects should be clearly formulated in an
experimental protocol which should be transmitted for consideration
for comment and guidance to a especially appointed committee
independent of the investigator and the sponsor, provided that
this independent committee is in conformity with the laws and
regulations of the country in which the research experiment is
performed.
zz Biomedical research involving human subjects should be conducted
only by scientifically qualified persons and under the supervision
of a clinically competent medical person. The responsibility for the
human subject must always rest with a medically qualified person
and never rest on the subject of the research, even though the subject
has given his or her consent.
zz Biomedical research involving human subjects cannot legitimately
be carried out unless the importance of the objective is in proportion
to the inherent risk to the subject.
zz Every biomedical research project involving human subjects
should be preceded by careful assessment of predictable risks in
comparison with foreseeable benefits to the subject or to others.

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148 Synopsis, Dissertation and Research to PG Students

Concern for the interests of the subject must always prevail over the
interest of science and society.
zz The right of the research subjects to safeguard his or her integrity

must always be respected. Every precaution should be taken to


respect the privacy of the subject and to minimize the impact of
the study on the subject’s physical and mental integrity and on the
personality of the subject.
zz Physicians should abstain from engaging in research projects

involving human subjects unless they are satisfied that the hazards
involved are believed to be predictable. Physicians should cease
any investigation if the hazards are found to outweigh the potential
benefits.
zz In publication of the results of his or her research, the physician

is obliged to preserve the accuracy of the results. Reports of


experimentation not in accordance with the principles laid down in
this declaration should not be accepted for publication.
zz In any research on human beings, each potential subject must be

adequately informed of the aims, methods, anticipated benefits and


potential hazards of the study and the discomfort it may entail. He
or she should be informed that he or she is at liberty to abstain from
participation in the study and that he or she is free to withdraw his
or her consent to participation at any time. The physician should
then obtain the subject’s freely given informed consent, preferably
in writing.
zz When obtaining informed consent for the research project, the

physician should be particularly cautious if the subject is in a


dependent relationship to him or her or may consent under duress.
In that case the informed consent should be obtained by a physician
who is not engaged in the investigation and who is completely
independent of this official relationship.
zz In case of legal incompetence, informed consent should be obtained

from the legal guardian in accordance with national legislation.


Where physical or mental incapacity makes it impossible to obtain
informed consent, or when the subject is a minor, permission from
the responsible relative replaces that of the subject in accordance
with national legislation.
Whenever the minor child is in fact able to give a consent, the
minor’s consent must be obtained in addition to the consent of the
minor’s legal guardian.

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Appendices 149

zz The research protocol should always contain a statement of the


ethical considerations involved and should indicate that the
principles enunciated in the present declaration are complied with.

Medical Research Combined with Professional Care


(Clinical Research)
zz In the treatment of the sick person, the physician must be free to use
a new diagnostic and therapeutic measure, if in his or her judgment
it offers hope of saving life, re-establishing health or alleviating
suffering.
zz The potential benefits, hazards and discomfort of a new method
should be weighed against the advantages of the best current
diagnostic and therapeutic methods.
zz In any medial study, every patient including those of a control
group, if any should be assured of the best proven diagnostic and
therapeutic method.
zz The refusal of the patient to participate in a study must never interfere
with the physician—patient relationship.
zz If the physician considers it essential not to obtain informed
consent, the specific reasons for this proposal should be stated in
the experimental protocol for transmission to the independent
committee (1, 2).
zz The physician can combine medical research with professional
care, the objective being the acquisition of new medical knowledge,
only to the extent that medical research is justified by its potential
diagnostic or therapeutic value for the patient.

Nontherapeutic Biomedical Research Involving Human


Subjects (Nonclinical Biomedical Research)
zz In the purely scientific application of medical research carried
out on a human being, it is the duty of the physician to remain the
protector of the life and health of that person on whom biomedical
research is being carried out.
zz The subjects should be volunteers—either healthy persons or
patients for whom the experimental design is not related to the
patient’s illness.

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150 Synopsis, Dissertation and Research to PG Students

zz The investigator or the investigating team should discontinue the


research if in his/her or their judgment it may, if continued, be
harmful to the individual.
zz In research on man, the interest of science and society should never
take precedence over considerations related to the well-being of the
subject.

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VI
APPENDIX

Proforma for Synopsis


of Dissertation Submission
within 6 Months after
Admission to the Course
........................... University Of Health Sciences, Karnataka
Bengaluru
Annexure- II
Proforma for Registration of Subjects for Dissertation
(Synopsis)
1. Name of the candidate and address
(in block letters)

2. Name of the institution

3. Course of study and subject

4. Date of admission to the course

5. Title of the topic

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152 Synopsis, Dissertation and Research to PG Students

6. Brief resume of the intended work:

6.1  Need for study:

6.2  Review of literature:

6.3 Objectives of the study:

7. Materials and methods:


7.1  Source of data:
    •  Study subjects:

    •  Inclusion criteria:

    •  Exclusion criteria:
    –  Study area:

    –  Study period:

7.2  Methods of collection of data:

    •  Study design:

    •  Sample size:

    •  Sampling procedure:

    •  Study instrument:

    •  Data collection:

    •  Study analysis:

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Appendices 153

7.3 Does the study require any investigations or interventions to be


conducted on patients or other humans or animals? (If so, please
describe briefly)

7.4 Has ethical clearance been obtained from ethical committee of your


institution in case of

8. List of references:

9. Signature of the candidate

10. Remarks of the guide

11. Name and designation


11.1 Guide

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154 Synopsis, Dissertation and Research to PG Students

11.2 Signature

11.3 Co-guide
11.4 Signature

11.5  Head of the department

11.6 Signature

12. 12.1 Remarks of the principal and


chairman

12.2 Signature

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VII
APPENDIX

Model Synopsis–1
Rajiv Gandhi University of Health
Sciences, Bengaluru, Karnataka
ANNEXURE-II

Proforma for Registration of Subjects for Dissertation


1. Name of the candidate DR. GEETA V. BATHIJA
and address (in block letter) PG in Community Medicine,
Community Medicine Deptt.
(P&SM) KIMS, Hubballi
2. Name of the institution Karnataka Institute of Medical
Sciences, Hubballi
3. Course of the study and subject MD in Community Medicine
4. Date of admission to course 15.10.1998
5. Title of the topic A study on the impact of leprosy
control in an urban field practice
area attached to leprosy
hospital (voluntary organization)
and ULC KIMS, Hubballi
6. Brief resume of the intended work:
6.1 Need for the study
a. To monitor and strengthen the strategies adopted in National
Leprosy Eradication Programme
b. To perceive the extent of sociological phenomenon in leprosy
eradication.
c. To demarcate the feasibility of the program to horizontal
program.

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156 Synopsis, Dissertation and Research to PG Students

6.2 Objectives of the study


a. To study the impact of leprosy control strategy through
indicators.
b. To identify the existing knowledge, attitude and practice with
respect to leprosy control.
c. To observe and record the extent of involvement of health
man power in Urban Leprosy Control Programme.
6.3 Review of literature
1. Dharmashaktu NS (1990) took an overview about problem
of leprosy before independence in India and strategies of
Leprosy Eradication Programme. Prevalence of leprosy
in India has fallen from 57/10,000 in 1981 to 5.2/10,000 at
present.
2. A study was conducted by Ashok Kumar, et al. (1991) on 84
paramedical workers in Chengalpattu (Tamil Nadu) to find
factors influencing operational efficiency of leprosy case
detection program. He found that awareness of leprosy
prevalence in their district was poor. 85% of them did not
perceive a definite role for them in rehabilitation of leprosy
patients.
3. Jesudasan K (1992) in his study on review of country situations
in Western pacific region of WHO, indicated that inspite of
some draw back, routine health services data provided very
useful information on epidemiology of leprosy and can also
be used to plan elimination program.
4. Habbema JDF, et al. (1992) in their study suggested with
their experience of over 10 years’ epidemiological models for
leprosy control. The success of decision models as an aid in
leprosy control cannot be guaranteed.
5. Raju MS and Kopparty SNM (1995) explored the impact of
knowledge on the attitudes of 1199 community members
from two states Andhra Pradesh and Orissa towards leprosy.
The results showed that over all high knowledge did not
necessarily generate positive attitude.
7. Material and methods:
7.1 Source of data
a. Personal interview of the cases on family background data in
prescribed proforma which is pretested by pilot study.
b. Monitoring of case finding diagnosis treatment, relapse,
disability and rehabilitation.

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Appendices 157

c. Review of records at leprosy hospital and ULC, Hubballi.


d. Doing and collecting the laboratory results.
e. Interrogation of health man power involved in leprosy
control.
7.2 Method of collection of data (including sampling procedure
if any)
  Structured questionnaire is prepared, pretested, finalized for
data collection. At the prevalence of 1/1000 population with
confidence interval 80% error/accuracy 20% and ± SE = 1.2816
the samples size of 409 cases or all cases existed on hand at the
time of study or all cases during the period October 1999 to Sept
2000 as time bound study are studied by personal interview,
clinical examination, laboratory investigation. Impact of the
program is recorded by survey and finding out the present
indicators from the population of the field practice area (1,50,000)
which are available in 32,608 families coverage of 10% of these
families viz., 3260 families by simple random sampling to get the
required number of cases is done. Corrected data is analyzed
with appropriate statistical test for final inference.
7.3 Does the study require any investigations or interventions to be
conducted on patients or other humans or animals. If so please
describe briefly.
Yes, skin biopsy, slit skins smear examination, skin lepromin test
are to be conducted as investigation. No animal experiment is
done.
7.4 Has ethical clearance been obtained from your institute in case
7.3.
Clearance from the ethical committee KIMS, Hubballi, has been
obtained.
8. List of references (About 4-6):
1. Dharmashaktu NS “Overview of Leprosy problem in India and
Strategies of National Eradication Programme” Indian Journal of
Leprosy Vol. 62(1) March 1990 pages 16-18.
2. Habbema JDF, et al. “Towards the use of Decision Sciences in
Leprosy Control” Leprosy Review 63 Supplement 1992 pages
48s-52s.
3. Jesudasan K. “Summary of Estimation of the Leprosy Problem
through health services data” Leprosy Review 63 Supplement
1992 pages 21s-22s.

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158 Synopsis, Dissertation and Research to PG Students

4. Kumar Ashok, et al. “The Factors influencing the operational


the operational efficiency of leprosy case detection programme”
Indian Journal of Leprosy Vol.63(2) 1991 pages 180-194.
5. Raju MS and Kopparty SNM. “Impact of knowledge of Leprosy
on the Attitude towards Leprosy patients A Community Study”
Indian Journal of Leprosy Vol. 67(3) 1995 pages 259-272.
  9. Signature of the candidate Sd/-
10. Remarks of the guide Submitted with Recomm-
endation after going
through MCI requirement
11. Name and designation of
(in block letters) Dr GN Prabhakara
11.1 Guide Professor and Head of the
Department of Preventive
and Social Medicine
Karnataka Institute of
Medical Sciences, Hubballi
01 JULY 2000
11.2 Signature Sd/- Dr GN Prabhakara
11.3 Co-guide (if any)
11.4 Signature
11.5 Head of department Professor and Head of the
Department of Preventive
and Social Medicine
Karnataka Institute of
Medical Sciences, Hubballi
01 JULY 2000
11.6 Signature Sd/-
12.1 Remarks of the chairman
and principal
12.2 Signature

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Appendices 159

Model Synopsis–2
Rajiv Gandhi University of Health
Sciences, Bengaluru, Karnataka
ANNEXURE-II

Proforma for Registration of Subjects for Dissertation


1. Name of the candidate Dr IA Loni
and address (in block PG in Community Medicine,
letter) KIMS, Hubballi
2. Name of the institution Karnataka Institute of Medical
Sciences, Hubballi
3. Course of study and subject MD in Community Medicine
4. Date of admission to course 02.09.1999
5. Title of the topic A study on the health profile
of under five children in RHTC
field practice area of KIMS, Hubballi
6. Brief resume of the intended work:
6.1 Need for the study
a. There is a need to note the change in pattern of morbidity
among under five children.
b. Current health profile will be useful tool for teaching and
training at RHTC by ROME specialists visits.
c. Extent of child service utilization is not known, which needs
recording.
d. Prevalence of intestinal parasitism is to be mapped out.
e. Health profile indicates and guides child care services in rural
field practice area.
6.2 Review of literature
a. A study of medico-social profile of under five children
suffering from diarrheal diseases by Dr Mahendrakar AG,
et al. at Pune (1991) showed that incidence of diarrhea
was more in low socioeconomic group, and is inversely
proportional to the literacy status of mother. Fifty percent of
mothers had no knowledge of ORT therapy.

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160 Synopsis, Dissertation and Research to PG Students

b. A study on aspects of Infant Mortality in villages of field


practice area of RHTC, Jawan, Aligarh by Dr Najam Khalique,
et al. (1990) showed an infant mortality rate of 79.32 per 1000
live births, 63.6% of deaths occurred in first 28 days of life.
Diarrhea was most common cause of death (21.2%) followed
by pneumonia (18.8%), tetanus (15.5%) and prematurity
(9.1%). Female deaths were more than male deaths.
c. A study on intestinal parasitism in children below 4 years in
a rural community near Calcutta by Dr DR Saha, et al. (1995)
showed that G. lamblia (17.2%) and A. lumbricoides (8.1%),
helminthic infections. A low infection rate was observed in
children below the age of one year.
d. A study to determine the prevalence of malnutrition among
urban slum children under five years of age at Bhopal,
Madhya Pradesh by Dr SN Dwivedi, et al. (1992) found that
prevalence of malnutrition was (63.4%), a higher prevalence
of malnutrition was seen among children of fifth and above
birth order. Prevalence of malnutrition gradually increased
with increasing size of the family.
e. A study on impact of maternal knowledge and practice on
nutritional status of infants by Dr IA Bhat, et al. in Srinagar
(1992) on Mothers attending child health clinic showed that
maternal awareness as well as practice of breastfeeding and
weaning exhibited a direct relationship with infants nutrition.
f. A study on utilization of maternity and child health services
in rural Jammu by Dr Prasantha K Majumdar, et al. (1994)
showed that location of health center played a positive role
in terms of knowledge and utilization of health services.
Education and per capita income was positively associated
with knowledge, type of services available and extent of
utilization of maternal and child health services.
6.3 Objectives of study
a. To find out morbidity and mortality pattern among under five.
b. To estimate the prevalence of intestinal parasitism.
c.  To study nutritional assessment including physical
development of under five group.
d. To study the dietary pattern of families.
e. To study the child rearing practices which influence the
health of under five children.
f. To study the extent of utilization of child care services.

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Appendices 161

7. Material and methods:


7.1 Source of data
a. Personal interview and clinical examination of child in
its family background, recording the data in prescribed
proforma which is pretested by pilot study.
b. Collection of stool sample and laboratory investigation.
c. Collection of data by nutritional assessment and anthro-
pometry.
d. Review of RHTC records.
e. Information collection through interrogation with child’s
mother or elderly person in the family.
7.2 Method of collection of data (including sampling procedure
if any)
   Structured questionnaire is prepared, pretested and finalized
for data collection. At 13% prevalence of under five and 20%
permissible error, the sample size worked out to be 646 or
all children below 5 years at the time of study in the place
of selection are studied during the period of March, 2000 to
February 2001 as time bound study by family visits, child
examination, laboratory investigations and interview. The
collected data is analyzed with appropriate statistical tests
for final inference.
7.3 Does the study require any investigations or interventions to
be conducted on patients or other humans or animals. If so
please describe briefly?
   Only routine investigation, clinical examination are done
on children. No interventions are applied. No animal
experiment is done.
7.4 Has ethical clearance been obtained from your institution in
case of 7.3?
   Clearance from Ethical Committee KIMS, Hubballi has been
obtained.
8. List of references:
1. Bhat IA, et al. “A Study on Impact of maternal Knowledge and
Practice on the Nutritional Status of Infants”. Indian Journal of
Maternal and Child Health, Vol. 3, Jan-March 1992 page 12-15.
2. Dwivedi SN, et al. “Malnutrition among Children in an Urban
Indian Slum and its Associations”, Indian Journal of Maternal and
Child Health, Vol. 3, July-Sept, 1992, page 79-81.

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162 Synopsis, Dissertation and Research to PG Students

3. Khalique Najam, et al. “Certain Aspects of Infant Mortality—


Prospective study in a Rural Community. Indian Journal of Maternal
and Child Health, Vol. 3, July-September 1992, page 85-88.
4. Mahendrakar AG, et al. “A Study of Medico-Social Profile of
under Five Children Suffering from Diarrhoeal Diseases”. Indian
Journal of Maternal and Child Health. Vol. 2, Oct-Dec, 1991, page
127-130.
5. Mazumdar PK, et al. “A Study on Utilisation of Maternity and
Child Health Services in a Rural Community Jammu, India”.
Health and Population, Vol. 17, Jan-June, 1994, page 4-34.
6. Saha DR, et al. “Intestinal Parasitism—A Childhood Problem in
Rural Bengal”. The Journal of Communicable Disease. Vol. 27,
Sept, 1995, page 170-174.
  9. Signature of the candidate Sd/-
10. Remarks of the guide It is a need based study
recommunicated
11. Name and designation of
11.1 Guide Dr GN Prabhakara
Professor and Head of the
Department of Preventive
and Social Medicine
Karnataka Institute of
Medical Science,
Hubballi
11.2 Signature Sd/-
11.3 Co-guide (if any) Professor and Head of the
Department of Microbio-
logy, Karnataka Institute
of Medical Sciences, Hubballi
11.4 Signature Sd/-
11.5 Head of the department Professor and Head of the
Department of Preventive
and Social Medicine
Karnataka Institute of
Medical Sciences, Hubballi
18 FEB 2000
11.6 Signature Sd/-
12.1 Remarks of the chairman
and principal
12.2 Signature

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Appendices 163

Model Synopsis–3
Rajiv Gandhi University of Health
Sciences, Bengaluru, Karnataka
ANNEXURE- II

Proforma for Registration of Subjects for Dissertation


1. Name the candidate Dr Chandan N
and address Post graduate student,
(In block letters) SDM college of medical sciences
and hospital, Dharwad – 580009
2. Name of the institution SDM college of medical sciences
and hospital, Manjushree Nagar, Sattur,
Dharwad – 580009
3. Course of study MD (Community medicine)
and subject
4. Date of admission 09-07-2014
to course
5. Title of the topic Evaluation of health insurance schemes
in rural areas attached to SDM college of
medical sciences hospital, Dharwad
6. Brief resume of the intended work:
6.1 Need for study: Stable and sustainable health financing is
considered an essential component for achieving important
population health goals. Health insurance is a method to
finance health care.1 The International Labour Organization
(ILO) defines health insurance as “the reduction or elimination
of the uncertain risk of loss for the individual or household by
combining a larger number of similarly exposed individuals or
households who are included in a common fund that makes
good the loss caused to any one member”.2
   Private financing of health care—through private voluntary
health insurance and out-of-pocket payments—continues to
represent a substantial share of health spending. In Brazil, China,
India, the Russian Federation and South Africa, private financing

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164 Synopsis, Dissertation and Research to PG Students

accounts for 54%, 44%, 69%, 40% and 52% of total health
spending, respectively.3 According to an analysis of financing on
hospitalization shows that a large proportion of people either
borrow money or sell assets to pay for hospitalization especially
among below poverty line population.
   In comparison with other countries with similar income
levels, government spending on health as a proportion of gross
domestic product is relatively low in China (2.9%), India (1.0%)
and the Russian Federation (3.7%), but it is higher in Brazil
(4.3%) and South Africa (4.1%).3
   The government-sponsored insurance schemes remain
focused entirely on hospital care. Despite new investments in
public primary care, many outpatients have been kept away from
the public sec­tor—and its promise of low cost health care—by
inadequate coverage and a common belief that the private sector
offers better quality.3
   Despite a government owned free health care delivery chain,
64% of the poorest population in India are indebted every year to
pay for the medical care they need. 85% of the Indian workforce
working in the informal sector do not have any kind of insurance
and lack access to effective social protection schemes.4,5
   So there is a need to evaluate the health insurance schemes
prevailing which makes health care through accessible low cost
effective health care.
6.2  Review of literature:
a. In a study conducted by Yamini KR in 2013 at Manipal it was
found that, the increase in the proportion of the insured to
the inpatients is significant statistically. The proportions
of inpatients in various plans among the insured has been
varying over years due to introduction of community or social
health insurance and its gaining popularity and acceptance
in rural areas.
    There has also been an increase in the proportion of
hospital inpatient revenue contributed by the insured. This
increase is statistically significant and is attributed to increase
in the proportion of insured inpatients themselves. Increasing
health care costs have resulted in an increase in the average
expense per inpatient admission. The difference in average
expense per admission among uninsured and insured is
statistically significant.1

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Appendices 165

b. In a study conducted by Vasavi P in 2013 in Andhra Pradesh.


Health insurance is like a knife. In the surgeon’s hand it can
save the patient, while in the hands of the quack, it can kill.
Health insurance is going to develop rapidly in future. The
main challenge is to see that it benefits the poor and the
weak in terms of better coverage and health services at lower
costs without negative aspects of cost increase and overuse of
procedures and technology in provision of health care.6
c. In a study by Yellaiah J in 2013 in Andhra Pradesh. It covered
a wide range of surgical and medical treatments for serious
illnesses requiring specialist health care resources not always
available at district-level government hospitals. The majority
of beneficiaries utilizing the scheme are illiterate and have a
rural address.7
d. In a study by Ranson MK. The study shows that community-
based health insurance schemes can effectively protect poor
households from the uncertain risk of medical expenses, and
they can be implemented in areas where institutional capacity
is too weak to organize mandatory, nationwide risk-pooling.
Such schemes can cover poor people, including people and
households below the poverty line.8
e. In a study by Verma R in 2013. Around 24% of all people
hospitalized in India in a single year fall below the poverty line
due to hospitalization. According to an analysis of financing
on hospitalization shows that a large proportion of people
either borrow money or sell assets to pay for hospitalization
especially among below poverty line population. In India,
there is need to take some steps and these shortcomings need
to be addressed so that every poor or rich, urban or rural
person should take advantage of health insurance scheme.4
Aims and objectives of the study:
•  To study the coverage and utilization of health insurance schemes.
•  To study the sociodemographic profile of the subjects under study.
7. Materials and methods:
7.1 Source of data: Families residing in Rural Field Practice Area of
SDM CMSH, Dharwad.
7.2 Study design: Community based cross-sectional study.
7.3 Sample size: According to a report submitted by Public Health
Foundation of India the health insurance coverage is 25%.9
Assuming a prevalence of 25% sample size is calculated by using
the formula 4pq/l2. With an allowable error of 20% the sample

Appendices.indd 165 09-10-2015 17:01:09


166 Synopsis, Dissertation and Research to PG Students

size calculated is 300 families. Where P is positive character, Q is


100 – P & l is the allowable error.
7.4 Sample procedure: Preliminary mapping is done. Systematic
random sampling procedure is followed in the study by selecting
every 5th family from the starting location.
7.5 Methods of collection of data: A pilot study is conducted to
finalize the structure questionnaire/proforma. Data is collected
in the proforma, through response from head of the family.
Additional information is collected in the respective insurance
offices or insurance officer concerned. Confirmation of data is
also done by the receipts/vouchers/bills available in the family.
 Instruments used for the data collection:
 Inclusion criteria: Families residing permanently in rural field
practice area.
 Exclusion criteria: Families not willing to participate in study.
 Study period: One year (November 2014 to October 2015)
 Statistical Analysis: The data is analyzed by statistical tests like
SE of the difference between two means, SE of the difference
between two proportions, X2, Z test, and analysis of variance.
Depending on the load of the data, SPSS is used in the statistical
analysis.
7.6 Does the study require any investigations or interventions to
be conducted on patients or other humans or animals? (If so,
please describe briefly)
No. The study do not require any interventions during the study.
7.7 Has ethical clearance been obtained from ethical committee of
your institution in case of 7.6?
8. List of references:
1. Yamini KR, Amaan M, Gomes LA, Somu G. A study of the
utilization of health insurance in a tertiary care teaching hospital.
JAHA. 2010;22(1&2):15-22.
2. International Labour Organization. ILO [Online]. http://www.
ilo.org/global/
3. Global Health Observatory Data Repository [Internet]. Geneva:
World Health Organization. 2014. Available from: http://apps.
who.int/gho/data/node.main?lang=en
4. Verma R, Singh A, Tyagi A, Chawla S, Bhalla K, Prinja S. Health
Insurance: Need of the hour in India. Int J Med Sci Public Health.
2013;3(2):161-5
5. Basu R: Rashtriya Swasthya Bima Yojana: Pioneering Public-
Private Partnership in Health Insurance. New Delhi: Jamia

Appendices.indd 166 09-10-2015 17:01:09


Appendices 167

Millia Islamia; 2010. [Online]http://www.napsipag.org/PDF/


RUMKI%20BASU.pdf
6. Vasavi P, Sravanthi Kpl. Evolution of Health Insurance in India.
Abhinav [Online].2013;2
7.  Yellaiah J. Health Insurance in India: Rajiv Aarogyasri
Health Insurance Scheme in Andhra Pradesh. IOSR-JHSS.
2013;8(1):07-14.
8. Ranson MK. Reduction of catastrophic health care expenditures
by a community-based health insurance scheme in Gujarat,
India: current experiences and challenges. Bull World Health
Organ.2002;14(8):613–621.
9. Public Health Foundation of India (2011),” A Critical Assessment
of the Existing Health Insurance Models in India”, Report of
Working Group, Submitted to Planning Commission of India.
9. Signature of the candidate
10. Remarks of the guide
It is a need based study that help in incorporating the observations
for the benefit of local community, for an effective affordable health
care.
11. Name and designation GN Prabhakara MD
11.1  Guide Professor and Head
Department of Community Medicine
SDMCMSH, Dharwad

11.2 Signature

11.3 Co-guide

11.4 Signature

11.5  Head of the GN Prabhakara, MD


  department Professor and Head
Department of Community Medicine
SDMCMSH, Dharwad
11.6 Signature
12. 12.1  Remarks of the
   Principal and chairman

12.2 Signature

Appendices.indd 167 09-10-2015 17:01:09


168 Synopsis, Dissertation and Research to PG Students

Sri Dharmasthala Manjunatheshwara College of


Medical Sciences and Hospital, Sattur, Dharwad

Informed Consent form

Title of the study: Evaluation of health insurance schemes in rural areas


attached to SDM college of medical sciences, Dharwad
Principal investigator: Co investigator/Guide:
Chandan N GN Prabhakara, MD
Postgraduate Student Professor and HOD
Department of Community Department of Community Medicine,
Medicine, SDM College of SDM College of Medical Sciences,
Medical Sciences, Sattur, Dharwad.
Sattur, Dharwad.
Information to the subjects: We are conducting a research project to
know the coverage and utilization of health insurance schemes in rural
areas. You have all the right not to consent or to withdraw your consent.
With your co-operation in the study, you will be helping us contribute to
scientific knowledge.
There is an informed consent form as a part of the research proforma.
You are requested to read the consent form thoroughly before signature.
If you are unable to read the proforma, then the investigator will explain
the procedure for you and you are requested to duly sign the informed
consent form.
Consent: I have been informed about the study and its probable
consequences. I understand that if I give my consent for the study. I have
been assured that complete confidentiality will be maintained regarding
my identity and the information collected from me. I have understood
that I have the right to refuse my consent or withdraw it any time during
the study.
I give my consent to be a part of this study.

Signature of the investigator Signature of the participant

Date:

Place:

Appendices.indd 168 09-10-2015 17:01:09


VIII
APPENDIX

PG Dissertation Evaluation Sheet


Marks are awarded on Rating Scale Procedure (RSP)
Adequate – 2
Marginal – 1
Not adequate – 0
Max: 54

Title Adequate Marginal Not adequate


1. Appropriateness
2. Clarity and brevity
3. Focus on topic
Introduction
4. Purpose of study
5. Mentioning of lacunae
in current knowledge
6. Good hypothesis
Review of Literature
7. Relevance
8. Completeness
9. Current and up-to-date
Material and Methods
10. Type of study correct
11. Details of study group and
control group
12. Details of material of study
13. Data collection procedure

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170 Synopsis, Dissertation and Research to PG Students

14. Statistical methods, level of


significance
15. Statement of limitations
16. Mention of ethical issues
Observation and discussion
17. Logical organization
of sections
18. Correctness of data analysis
19. Appropriateness of
data representation
20. Good statistical
interpretation
21. Objectivity of interpretation
22. Appropriateness and
relevance of data
23. Interpretation
24. Limitations in interpretation
25. Mention of unanswered
questions
26. Mention of new question
raised
Appendix
27. Required appendix

Appendices.indd 170 09-10-2015 17:01:09


IX
APPENDIX

Model of ‘Review of Literature’


1. A study of medico-social profile of under five children suffering
from diarrheal diseases by Dr Mahendrakar AG, et al. at Pune (1991)
showed that incidence of diarrhea was more in low socioeconomic
group, and is inversely proportional to the literacy status of mother.
Fifty percent of mothers had no knowledge of oral rehydration
therapy (ORT) therapy.
2. A study was conducted by Ashok Kumar, et al. (1991) on 84
paramedical workers in Chengalpattu (Tamil Nadu) to find factors
influencing operational efficiency of leprosy case detection program.
He found that awareness of leprosy prevalence in their district
was poor. 85% of them did not perceive a definite role for them in
rehabilitation of leprosy patients.
3. In a study conducted by P Vasavi in 2013 in Andhra Pradesh. Health
insurance is like a knife. In the surgeon’s hand it can save the
patient, while in the hands of the quack, it can kill. Health insurance
is going to develop rapidly in future. The main challenge is to see
that it benefits the poor and the weak in terms of better coverage
and health services at lower costs without negative aspects of cost
increase and overuse of procedures and technology in provision of
health care.
4. Piramanayagam P, et al. in their study have found a persistently high
HIV seroprevalence among TB patients presenting to the tertiary
care center in Delhi (8.3%). Risk factors for HIV seropositivity
included high-risk sexual behaviors (48% in HIV/TB coinfected vs
6% in TB infected) and history of blood transfusion (23% in HIV/TB
coinfected vs 5% in TB infected).

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172 Synopsis, Dissertation and Research to PG Students

5. R Ramchandran, et al. in their study have found the overall HIV


seroprevalence among TB patients to be 4.7%. The highest HIV
seropositivity rate was found among patients aged 30–39 years
(10.6%). HIV seroprevalence showed a wide variation among the
different centers ranging from 0.6 to 9.4%.

Appendices.indd 172 09-10-2015 17:01:09


X
APPENDIX

Guidelines for Writing References


JOURNAL
1. Prabhakara GN. “A case study on Internship Training—Diagnostic
studies on Internship part III”, 1986 IJME XXV: 3: PP 13-19.
2. Prabhakara GN. “Infant feeding patterns in slums of Bengaluru”
1987 Indian Paediatrice 24:10: PP 895-898.
3. Yamini KR, Amaan M, Gomes LA, Somu G. A study of the utilization
of health insurance in a tertiary care teaching hospital. JAHA.
2010;22(1&2):15-22.
4. Thomas BE, Ramachandran R, Anitha S, Swaminathan S.
Feasibility of routine HIV testing among TB patients through a
voluntary counselling and testing centre. Int J Tuberc Lung Dis
2007;11(12):1296-1301.
5. Jain SK, Aggarwal JK, Rajpal S, Baveja U. Prevalence of HIV infection
among. Tuberculosis patients in Delhi-a sentinel surveillance study.
Ind J Tub. 2000:47:21-26.
  Note that the article is in quotation marks, the journal can be
sometimes underlined or in italics. There are some punctuation
difference from journal to journal.

THESIS OR DISSERTATION
Raveendra HR. A study on the knowledge and attitude of STD patients
attending Karnataka Medical College Hospital, Hubballi, regarding
HIV infection/AIDS (unpublished Doctoral Dissertation, Karnataka
University, Dharwad 1995, pp. 223.

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174 Synopsis, Dissertation and Research to PG Students

UNPUBLISHED MATERIAL
Prabhakara GN—Medical Internship, a review Medical Education Cell,
JIPMER, Puducherry 1974, pp. 73 (Mimeographed).

NEWSPAPER ARTICLE
Editorial in “Deccan Herald” January 18, 2001.

CHAPTER WRITTEN BY AN AUTHOR OTHER THAN


EDITOR OF THE BOOK
Asha Oumachigui—“Objective Structured Clinical/practical
Examination” chapter 22 in Medical Education—Principles and
Practice. Edn. N. Ananthakrishnan NTTC, JIPMER 2000, 190 pp.

EDITOR AS AUTHOR
Adhikari, Ramesh, Jayawikramarajah Ed. Essentials of Medical
Education. Health Learning Materials, Centre, Kathmandu Institute of
Medicine, Tribhuvan University 1996, pp. 180.
Note that this is a publication of an agency, therefore, the place of
publication follows the name of agency.

TEXTBOOKS
Three authors:
Robert C Aber, et al—Hospital Infections
Boston: Little, brown and company 1986, pp. 666.
Two authors: (Joint authors)
Kulkarni AP, Baride JP—Textbook of Community Medicine, Mumbai,
Vora Medical Publications 1998, pp. 537.
Single authors:
Prabhakara GN—Short Textbook of Professional Medical Ethics,
Hyderabad, Paras Med Pub 2001, pp. 196.

Appendices.indd 174 09-10-2015 17:01:09


Appendices 175

DIFFERENT COMPONENTS OF REFERENCE FOR


TYPING PROCEDURE
1. Indentation: Overhanding first line flush with margin, second line
indented five spaces.
2. Name order: Last name first (of first author when more than one
author).
3. Placement: End of body of report-listed alphabetically by last name
of first author.
4. Punctuation: Author name, title, place of publication: publisher,
state of publication.
5. Page reference: Total number of pages in book or in the journal
article.

Appendices.indd 175 09-10-2015 17:01:09


XI
APPENDIX

Permissible Error and Confidence


Interval for Sample Size
Determination
Confidence Interval Error/Accuracy Distance of SE
99% 1% 2.57
98% 2% 2.32
97% 3% 2.17
96% 4% 2.05
95% 5% 1.96
94% 6% 1.88
93% 7% 1.81
92% 8% 1.75
91% 9% 1.69
90% 10% 1.6448
80% 20% 1.2816
70% 30% 1.03
60% 40% 0.8416
50% 50% 0.6745

Appendices.indd 176 09-10-2015 17:01:09


XII
APPENDIX

Cumulative Distribution
of Chi-Square
DF Probability of a greater value
0.5 0.25 0.1 0.05 0.01 0.005 0.001
1 0.45 1.32 2.71 3.84 6.63 7.88 10.83
2 1.39 2.77 4.61 5.99 9.21 10.60 13.82
3 2.37 4.11 6.25 7.81 11.34 12.84 16.27
4 3.36 5.39 7.78 9.49 13.28 14.86 18.47
5 4.35 6.63 9.24 11.07 15.09 16.75 20.51
6 5.35 7.84 10.64 12.59 16.81 18.55 22.46
7 6.35 9.04 12.02 14.07 18.48 20.28 24.32
8 7.34 10.22 13.36 15.51 20.09 21.96 26.13
9 8.34 11.39 14.68 16.92 21.67 23.59 27.88
10 9.34 12.55 15.99 18.31 23.21 25.19 29.59
15 14.34 18.25 22.31 25.00 30.58 32.80 37.70
20 19.34 23.83 28.41 31.41 37.57 40.00 45.32
25 24.34 29.34 34.38 37.65 44.31 46.93 52.62
50 49.33 56.33 63.17 67.50 76.15 79.49 – 
100 99.33 109.14 118.50 124.34 135.81 140.17 –

Appendices.indd 177 09-10-2015 17:01:09


XIII
APPENDIX

Short Table of Areas


of Normal Curve
Z 1-P P
0.0 0.0000 1.0000
0.1 0.0979 0.9203
0.5 0.3829 0.6771
1.0 0.6827 0.3173
1.5 0.8664 0.1336
1.64 0.9000 0.1000
1.96 0.9500 0.0500
2.0 0.9545 0.0455
2.5 0.9876 0.0124
2.58 0.9901 0.0099
3.9 0.9999 0.0001

General tips for statistical inference


If Z calculated is more than 2, it is significant (P-0.05)
If Z calculated is more than 3, it is highly significant (P-0.001)

Appendices.indd 178 09-10-2015 17:01:09


XIV
APPENDIX

The Distribution of ‘t’


(Two Tailed Tests)
DF Probability of a larger value, skin ignored
0.5 0.1 0.05 0.01 0.005 0.001
1 1.000 6.314 12.706 63.657 –  – 
2 0.816 2.920 4.303 9.925 14.089 31.598
3 0.765 2.353 3.182 5.841 7.453 12.941
4 0.741 2.132 2.776 4.604 5.598 8.610
5 0.727 2.015 2.571 4.032 4.773 6.859
6 0.718 1.943 2.447 3.707 4.317 5.959
7 0.711 1.895 2.365 3.499 4.029 5.405
8 0.706 1.860 2.306 3.355 3.832 5.041
9 0.703 1.833 2.262 3.250 3.690 4.781
10 0.700 1.812 2.228 3.169 3.581 4.587
15 0.691 1.753 2.131 2.947 3.286 4.073
20 0.687 1.725 2.086 2.845 3.153 3.850
25 0.684 1.708 2.060 2.787 3.078 3.725
50 0.680 1.676 2.008 2.678 2.937 3.496
100 0.687 1.661 1.982 2.625 2.871 3.390

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XV
APPENDIX

First Aid: HIV/AIDS


Ward facility for first aid in case of accidental exposure of staff on duty.

REQUIREMENTS
zz Soap
zz Water
zz Spirit
zz Sodium hypochlorite solution
zz Zidovudine tablet for on hand 2 day course
zz Tray with sodium hypochlorite solution to which disposable
syringes/needles to be put and later to final disposal
zz Hospital waste bin kept ready for disposables.

ANY NEEDLE PRICK, PUNCTURE WOUND


Is made to bleed freely under a running tap to wash out any infected
material.
Immediate reporting to higher authorities for prophylactic treatment.
Ziduvidin drug prophylactic (monodrug) started within 6 hours.
On third day blood sample is sent to Poona for HIV test either to stop
drug (if –ve) or to give proper course (if +ve).

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XVI
APPENDIX

Hospital Guidelines
for Severe Acute Respiratory
Syndrome Control
zz Rapid diversion of suspected case in outpatient and N 95 mask to
such patients.
zz Staff involved to wear N 95 mask, wash hands before each patient
examination.
zz Inpatient with independent air supply, exhaust system and bath-
room facility.
zz Appropriate disposal equipment are used.
zz Visitors are given PPE (Personal Protective Equipment).
zz Restriction to nonessential staff to severe acute respiratory syndrome
(SARS) ward is followed.
zz Alcohol based skin disinfectants are used.
zz Special care in interventions like nebulizer, chest physiotherapy,
bronchoscopy, gastroscopy, etc.

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XVII
APPENDIX

Format for Ethical Committee


Meeting Submission by
Postgraduates
zz Title:
zz Investigators:
zz Description of the study:
zz Interventions Present/Absent
zz Intervention if Yes Detail
zz Copy of synopsis enclosure
zz Copy of the informed consent enclosed

Signature of PG Signature of Guide Co-guide

HOD of the Department Chairman of Ethical


Committee

Space for notes for the committee ...............................................................

.........................................................................................................................

Appendices.indd 182 09-10-2015 17:01:09


Index
Page numbers followed by f refer to figure and t refer to table.

A Computer ethics 34
Computer parts 116
Academic course 13 Consumer Protection Act (COPRA) 35
Animal and experimental research 27 medical ethics 35
basic techniques in 29 professional misconduct 37
Autonomous ethics 17 Contributory negligence 16
Averages 80 COPRA See Consumer Protection Act
comparative table of 83t (COPRA)
Corporate negligence 16
B Criminal negligence 16
Cross-sectional study 45t
Bar diagram 73, 76f, 104
component 77
Bioethics 17 D
major principles of 20
Data analysis
Biostatistics 66, 103
software for 117
Blinding 51
double 51 Data presentation 74
single 51 Data source 74
triple 51 Data types 74
types of 51 Declaration of Helsinki 18
Demographic data 72
Departmental routine 4
C Descriptive study 44
steps in 45
Case control studies 46, 47
uses of 45
differences between 46t
Diagrams 73, 75
Central tendency measures 81
Digital reference 63
Charts 75
Chi-square test 95, 124 Digital subscriber line 119
Civil negligence 16 Disinfection procedure 111
Clinical trial 49 Dissertation 12, 58
steps in 49 content 59
Coding and editing 71 discussion 61
Coefficient of variation (CV) 84, 87 material and methods 60
Cohort study 47 observation and discussion 60
examples of 49 reference 61
uses of 48 review of literature 60

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184 Synopsis, Dissertation and Research to PG Students

title 59 Human experimentation 29


yearwise 14 check points in 30
Doctor patient relationship 22 ideal 30
Drug trial 26 Human study
stages of 49

E
e research 34
I
Educational spiral 8f Indian Medical Council Act 19
Estimates 67 Informed consent 23
point 67 Institutional routine 4
Ethical issues Interdepartmental routine 5
in AIDS patients 32 Interval scale 69
in cancer patients 30 Introductory course 2
in children 32
in mentally ill patients 33
of symbols 33 J
with alternative medicine 34
Ethical principles Journal club 5
achievement 21 requisite at 6
Ethical review committee 24
L
G Laboratory and clinical trials 26
General course 12 Lesson plan 10
Genetic disorders 31 additions in 11
Genetic research approaches in 10
general ethical principles in 30 elements of 10
Graphical representations 72 important points in 11
preparation of 11
Level of significance 93
H Line diagram 78f
Literature search
Heteronomous ethics 17
software for 118
High-risk procedures 109
Longitudinal study 45t
dialysis 111
dressing of wounds 109
injections 109 M
investigative procedure 110
laboratory investigations 110 Map diagram 104
management of delivery 110 Matched pair design human voluntary
surgical procedures 109 research 25
HIV/AIDS MCI code of ethics 20
control and prevention 113 Mean 81
Hospital waste Mean deviation 84
discard and disposal 112 steps to calculate 85

Index.indd 184 20-10-2015 15:05:33


Index 185

Median 81 Research design


Medical ethics 16 college level activity in 52
perspective of 17 drafting of outline 40
Methods of sterilization 111 nature of topic 41
Mode 81 need of 40
specific objectives 39
steps in 42
N Research trial
types 43
Nominal scale 68
Right to information 24
Null hypothesis 97
Nuremberg code 18
S
O Sample size 87, 88, 90
determination
Operating system 119    software for 117
Ordinal scale 69 Severe acute respiratory syndrome
Organ donation 22 protection against 115
requirement in 23 Simple random sample 105
Spearman rank correlation test 139,
102
P Standard deviation 84, 85
Parameters 66 steps to calculate 85
Patient Self-determination Act 20 Standard error of difference
Pearson correlation 136 between two means 120
Pearson product moment coefficient between two proportions 122, 123
100 Standard error 92
Pedagogue 8 of difference between two means
Pictogram 79   94
Pie diagram 79, 104 of difference between two
Postgraduate course 1    proportions 94
expectations 2 Statistical estimates 67f
master plan 12 Statistics 64
P value 93 characteristics 65
descriptive 68
Postgraduate training 3
inferential 68
Practicals 12
primary objective of 64
Pubmed style 62
terminologies used 65
WHO definition 64
R Statistics course
significance 66
Randomization steps 51 Student T-test 126, 130, 132
Randomized clinical trial 50 Study design 48, 50
Range 84 Study objective 55
Ratio scale 70 Subject seminar
References list 56 objective 7

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186 Synopsis, Dissertation and Research to PG Students

Subject seminar 6 U
Synopsis 53
review 53 Unpaired T-test 99
title of the topic 54
V
T Vancouver style of writing
reference 62
Table Variability, measures of 84
cross 75 Variables 92t
dummy 80 Viva 12
multivariable 76 Vulnerable protection 24
random 108
simple 75
T-test 98
W
Tabulation of data 71 WHO declaration of geneva 18
Tabulation of morbidity 72
Tabulation of mortality 72
Tests of significance 92
Z
Theory 12 Z test 96, 134

Index.indd 186 20-10-2015 15:05:34

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