0% found this document useful (0 votes)
28 views51 pages

Introduction To Research Methodology

The principles of research in medicine

Uploaded by

Ayooluwa Olaniyi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
28 views51 pages

Introduction To Research Methodology

The principles of research in medicine

Uploaded by

Ayooluwa Olaniyi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
You are on page 1/ 51

INTRODUCTION

TO RESEARCH
METHODOLOG
Y
DR BASHIR YUNUSA (MBBS,MSC,FWACS)
GENERAL SURGEON FMC, ABUJA, NIGERIA.
OUTLINE

• DEFINITION
• OBJECTIVES OF RESEARCH
• TYPES
• STUDY DESIGN
• LEVELS OF EVIDENCE
• RESEARCH PROCESS FLOW
CHART
• HYPOTHESIS TESTING
• WRITING A FULL-LENGTH
PAPER
• PROPOSAL FOR DISSERTATION
• RECOMMENDATIONS
• REFERENCES
DEFINITION

• Research methodology is the strategic framework


that outlines the systematic process researchers use
to collect, interpret, and analyze data.
• It acts as a roadmap, providing a structured path for
investigators to follow, ensuring the reliability and
validity of their findings.
• In essence, it is the blueprint that governs your entire
research journey.
OBJECTIVES OF RESEARCH
• The purpose of research is to discover answers to questions through
the application of scientific procedures. Some of the objectives are;
I. To gain familiarity with a phenomenon or to achieve new insight to it.
II. To portray accurately the characteristics of a particular individual, situation
or a group.
III. To determine the frequency with which something occurs or with which it
is associated with something else
IV. To test a hypothesis of a causal relationship between variables
TYPES OF REASEARCH

• There are three main types of research methodologies:


• Qualitative Research,
• Quantitative Research,
• Mixed Methods.
• Qualitative Research:
• It employs non-numerical data such as interviews,
observations, and open-ended surveys to explore the
complexities of human behaviour, attitudes, and experiences.
• This method is ideal for uncovering nuanced insights that
quantitative methods might overlook.
• It is particularly valuable in fields such as sociology,
psychology, and anthropology, where the aim is often to
understand the underlying motivations and meanings behind
human actions.
• Quantitative Research:
• Is concern with the collection and analysis of numerical data.
• It employs structured surveys, experiments, and statistical
analyses to identify patterns, relationships, and trends within a
large dataset.
• It provides a more objective and measurable approach to
research.
• Its commonly used in fields like economics, medicine, and
engineering, where the goal is often to quantify phenomena and
draw statistically significant conclusions.
• This method is characterized by its emphasis on objectivity and
the ability to generalize findings to a broader population.
• Mixed Methods.
• This hybrid approach integrates the best of both worlds,
allowing you to gather a comprehensive understanding of your
research question.
• It involves collecting and analysing both qualitative and
quantitative data, providing a more holistic perspective.
STUDY DESIGN
STUDY DESIGN

Time

Descriptive study Distribution Place

Person
Epidemiology

Analytic study Risk factors Etiology


STUDY
DESIGN
• STUDY DESIGNS can be classified as
• Descriptive or
• Analytical (inferential) studies.
DESCRIPTIVE AND ANALYTIC
EPIDEMIOLOGY

DESCRIPTIVE ANALYTIC

When was the How was the


population affected? population affected?

Where was the population Why was the


affected? population affected?

Who was affected?


STUDY DESIGN
• Descriptive studies describe the characteristics of interest in the
study population.
• These studies do not have a comparison group.
• The simplest type of descriptive study is the case report. In a case
report, the researcher describes experience with symptoms, signs,
diagnosis, or treatment of a patient.
• Sometimes, a group of patients having a similar experience may be
grouped to form a case series.
STUDY DESIGN
• Analytical or inferential studies try to prove a hypothesis and
establish an association between an exposure and an outcome.

• These studies usually have a comparator group.

• Analytical studies are further classified as observational or


interventional studies

• In observational studies; The researcher merely observes outcomes in


different groups of participants who, for natural reasons, have or have
not been exposed to a particular risk factor. E.g of observational
studies include cross-sectional, case–control, and cohort
studies.
Cross-sectional Studies
• In cross-sectional studies data are collected from the study population
at a single point in time.
• Exposure and outcome are determined simultaneously.
• Prevalence of health conditions and possible associations between
risk factors and outcomes can be determine.
Cross-sectional Studies
• Limitations;

1. May not be possible to establish a clear cause–benefit


relationship. E.g in a study of association between colon
cancer and dietary fiber intake, it may be difficult to establish
whether the low fiber intake preceded the symptoms of colon
cancer or whether the symptoms of colon cancer resulted in a
change in dietary fiber intake.

2. Survival bias. E.g. in a study looking at alcohol intake vs


mortality due to chronic liver disease, among the participants
with the highest alcohol intake, several may have died of liver
disease; this will not be picked up by the study and will give
biased results
Cross-Sectional Study

Subjects are selected because


they are members of a certain
population subset at a certain
time

19
Case–control Studies

• Case–control studies are always retrospective, i.e., the outcome of


interest has occurred when the study begins.

• The researcher identifies exposed (cases) and non-exposed


(controls).

• Matching is done based on factors that are likely to influence the


exposure or outcome (e.g., age, gender, socioeconomic status).

• Exposure (risk factor) and outcome (disease) is studied in case and


control participant.
Case–control Studies
• Limitations;
• First, matching of cases with controls may not be easy since many
unknown confounders may affect exposure and outcome.
• Second, there may be biased in the way the history of exposure is
determined in cases vs controls.
Case-Control Study

Subjects identified as having a


disease or condition are
compared with subjects without
the same disease or condition

22
Cohort Studies
• The researcher begins with a group of individuals who are free of
outcome at baseline; of these, some have the exposure (study
cohort) while others do not (control group).

• The groups are followed up over a period of time to determine


occurrence of outcome.

• Cohort studies may be prospective (involving a period of follow-up


after the start of the study) or retrospective (e.g., using medical
records or registry data).
Cohort Studies
• Cohort studies are considered the strongest among the
observational study designs.
• They provide proof of exposure occurred before outcome, allow
determination of risk, and permit multiple outcomes to be studied
for a single exposure.
• However, they are expensive to conduct and time-consuming,
there may be several losses to follow-up, and they are not
suitable for studying rare outcomes. Also, there may be
unknown confounders other than the exposure affecting the
occurrence of the outcome.
Cohort Study

Subjects are categorized on the


basis of their exposure to one
or more risk factors

25
LEVEL OF EVIDENCE
Level of evidence
1 2 3 4 5

Level 1: (higher Level 2: Lesser Level 3: Case-control Level 4: Case series; Level 5: (lower
quality of evidence) – quality RCT; study (therapeutic case-control study quality of evidence) –
High-quality prospective and prognostic (diagnostic studies); Expert opinion.
hierarchy

randomized trial or comparative study; studies); poor reference


prospective study; lesser quality retrospective standard; analyses
testing of previously prospective study; comparative study; with no sensitivity
developed diagnostic development of study of analyses.
criteria on diagnostic criteria on nonconsecutive
consecutive patients. consecutive patients; patients without
systematic review of systematic review of consistently applied
Level I RCTs and Level II studies or reference “gold”
Level I studies. Level I studies with standard; analyses
inconsistent results. based on limited
alternatives and costs
and poor estimates;
systematic review of
Level III studies.
COMMONLY ACCEPTED HIERARCHY:
• 1. Systematic reviews and meta-analyses: Considered the highest level of evidence, as they
synthesize and analyze data from multiple high-quality studies.
• 2. Randomized controlled trials (RCTs): RCTs are considered the gold standard in research
design, as they minimize confounding variables and bias through randomization and control
groups.
• 3. Cohort studies: These studies follow a population over time, examining the relationship
between exposures and outcomes.
• 4. Case-control studies: These studies compare individuals with a specific outcome (cases) to
those without the outcome (controls), examining potential risk factors.
• 5. Cross-sectional studies: These studies examine a population at a single point in time,
providing a snapshot of associations and prevalence.
• 6. Surveys and questionnaires: Self-reported data from individuals, which may be subject to
bias and limitations.
• 7. Case series and case reports: Descriptive studies of a small number of cases, often used to
generate hypotheses or report rare events.
• 8. Expert opinion and consensus statements: Based on the opinions and experiences of experts
in the field, rather than empirical evidence.
• 9. Anecdotal evidence: Personal experiences and stories, which may be biased and unreliable.
RESEARC
H
PROCESS
FLOW
CHART
HYPOTHESIS TESTING
• An assumption, proposal to explain observations or fact that requires
further investigation to be verified.
• Sample is taken from a population to draw conclusion for the entire
population
• A hypothesis should be short, precise, specific and capable of
verification
• There are eight (8) steps in hypothesis testing
STEPS OF HYPOTHESIS TESTING
• STEP 1; STATE THE NULL HYPOTHESIS Hₒ :
Hypothesis of no difference.
E.g there is no statistically significant difference between the mean height of
the population of male and female resident doctors
• STEP 2; STATE THE ALTERNATE HYPOTHESIS H₁ :
The opposite of the null hypothesis
There is statistically significant difference in the mean height of the
population of male and female resident doctors
• STEP 3; STATE THE α-LEVEL OF SIGNIFICANCE :
By international convention set at 5%
P value of 0.05
If the calculated test value falls in the rejection zone, the null hypothesis is
rejected and the alternate hypothesis accepted.
STEPS OF HYPOTHESIS TESTING
• STEP 4; CHOOSE THE APPROPRIATE TEST STATISTIC :
This is important to get the right outcome.
E.g of test statistic; z, t, x², f,
Z, t, f are used for quantitative variables
x² is used strictly for qualitative variables
Z , t test are used when mean in one or two groups
F is used when comparing mean in ≥3 groups
If the population standard deviation is known, you must use z-test
regardless of the sample size.
If the sample size is large ≥ 30 use z-test.
If the sample size is less than 30 use t-test.
STEPS OF HYPOTHESIS TESTING
• STEP 5; DRAW THE DISTRIBUTION CURVE OF THE CHOSEN STATISTIC
AND INDICATE THE REJECTION ZONE
• STEP 6; CALCULATE THE VALUE OF THE TEST STATISTIC
• Using the appropriate formula
• STEP 7; DECISION MAKING
• If calculated value falls in the rejection/critical zone, reject the null
hypothesis and accept the alternate hypothesis
• STEP 8; OBTAIN THE P-VALUE
WRITING A FULL-LENGTH RESEARCH
PAPER
• A full-length paper is a manuscript with clear cut outline; IMRAD
(Introduction, Methods, Results, Analysis and Discussion).
• The IMRAD is preceded by a Title page and the conflict of interest and
abstract. It is followed by the references and acknowledgement.
• This may vary based on the journal intended for publication. Or the
guidelines of the intended examining body. E.g attestation page,
ethical approval etc.
TITLE PAGE

• Title of the paper


• The author(s)
• Address of the author, phone number, e-mail address.
• Address of the institution the work is carried out
• Grant support
• Month and year of publication
• The title should be concise and truly reflect the substance of the paper
• < 45 characters including the spaces in between words
• Use word that captures attention the word forward as first or second to
highlight the problem
Types of title
• There 3 types of title;
• Declarative; States the main finding of the study in the title itself, it reduces
the curiosity of the reader, may point toward a bias on the part of the author
and hence is best avoided. E.g Teenage abortion cause infertility.

• Non- declarative; They raise issues that need to be confirmed or ortherwise,


through careful study. E.g Infertility in patients with history of abortion in
teenage years.

• Interrogative; These are title that are framed as questions. This can create
interest by making the reader immediately wonder what the answer might be.
It is also a concise way of presenting the research topic.
ABSTRACT
• Written in past tense
• Not more than 250 words
• Structured or unstructured
• No indentation
• No sentence should start with a figure or number. Such number should be put in words
at the beginning of sentence
• No references should be sited
• All statement must be derived from the work done and reported in the manuscript
• The abstract should follow the IMRAD pattern
• Results should be concise and percentages roundup
• Statistical test and level of significance mentioned
• Key words ;3-10, separated by comma, first letter in capital, they serve the search
engine to locate paper
ABSTRACT
• An abstract must answer the the following questions ;
1. Why should I bother to read it? – title
2. Why did you do it?- introduction and objectives
3. How did you do it ? – methods
4. What did you find?- results
5. What does it mean?- discussion
6. What should I do know ?- conclusion
INTRODUCTION
• Brings up the problem in full perspective
• Significance of the study by providing a good background of the disease or other
object of interest.
• References should be between 5-15.
• An engaging introduction;
Address a problem
Significance of problem (morbidity, mortality, or new knowledge)
Give a background literature
Outline the objectives
Its hypothesis must be clear and concise
Give justification
The scope of the study (the general area to be studied)
METHODOLOGY
• Describe the method of study in a clear and simple terms.
• It must be reproducible by another scientist elsewhere
• Any modification of established procedure must be stated clearly and
referenced properly if it has been used before.
• Manufacturer names and models of tools or reagents should be
mentioned
• Inclusion and exclusion criteria should be clearly stated.
• Studies using Animal or human subjects, must conform to the Helsinki
declaration of 1975
• Drugs trials used must be registered in public registry
• Statistical method and software should be mentioned
METHODOLOGY
• Study population
• Study design
• Study duration
• Inclusion criteria
• Exclusion criteria
• Sample size estimation
• Detailed methodology
• Statistical analysis of outcome
RESULTS
• The results should be presented in a logical sequence
• Should always reflect on the aims of the study
• The discussion and conclusion is also based on the results.
• It is written in past tense
• Results should be in form of text, tables and illustrative figures.
• Numerical values and their percentages are reported
• Tables and figures should not be repeated in the text but serve as reference only
• References should not be sited
• Do not explain or justify any figure, the section of discussion will take of it
• Tables are numbered serially in Arabic numerals e.g Table 1.
• Should have short title not sentence, not ended with full stop.
• Many journals discourage tables with vertical lines to avoid overcrowding.
• Avoid symbols or abbreviations. If used should be explained
Table 6: Distribution of Human
Bites
Bites Number of patients Proportion (%)
Minor Bites 30 15

Intermediate Bites 80 40

Major Bites 90 45
DISCUSSION
• Discussion is based purely on the results of the study
• The main findings should be discussed first, followed by its significance and
implication.
• Strength and weakness of the study design should be discussed
• Results should be compared with similar previous studies in literature
• Strength and weakness of methodology compared to similar studies should
be discussed
• The meaning of study, implication to clinicians or scientist, policymakers,
patients, its addition to the body of knowledge and limitations should be
discussed.
• Ordinarily not to exceed 4 pages (double spacing)
• Should be in past tense
DISCUSSION
• The main building blocks of a sound discussion section are;
• The main findings
• Strength and weaknesses of study design
• The significance and implication of findings
• Citation of relevant references
• Limitations
• Conclusion
CONCLUSION

• The conclusion(s) must have a direct relationship with the aims and
objectives of the paper and could be drawn only from the results of
the study.
REFERENCES
• The references or the citing of the literature used in the text relate
only to the core issues of the work done.
• The list of references greater or equal to the volume of the written
study is no evidence of quality, or scholarship.
• It is expected the author have read the works cited
• The more current the selected references, the better.
• There two commonly used methods of formatting references;
• Vancouver system
• Harvard system
Vancouver system

• Hendrickse RG, Montefiore D, Sherman P, Paradze T. Comparative trial


of further attenuated measles vaccine. Br Med J 1996; 5490: 779-781.
Format for proposal for dissertation
• ResearchProposalOutline.pdf
RECOMMENDATIONS

• Proposal should be presented within 6 months of passing


membership/ part one
• Regular Updates pf knowledge on research and statistics
• Get involve in research with your consultants
• Frequent journal reviews
Reference
1. Ugwu BT, Omigbodun AO. A practical guide to medical manuscript
writing. West African college of surgeons. 2010. www.wacs-coac.org.
2. Hennekens CH, Buring JE. Epidemiology in Medicine. 1st ed.
Philadelphia, USA: Lippincott Williams & Wilkins; 1987.
3. Kothari CR, Garg G. Research methodology; methods and techniques.
4th ed. New delhi, India: New age international publishers; 2020.
4. What are analytic study design.Sept.,19 2022.www.Aje.com
5. Wang X, Kattan MW. Cohort Studies: Design, Analysis,
and Reporting. Chest. 2020 Jul;158(1):72-78.

You might also like