Clinical Research Proposal Guidelines for Paediatric Residents undertaking

Dissertation Research for MMed Degree at University of Nairobi

DEVELOPMENT OF RESEARCH CONCEPT PAPER

a) Developing subject interest;

Identify a child health issue of concern. This should be guided by clinical exposure, previous literature other
currently topical issue. A crude research question can be constructed at this stage.

b) Initial reading;
This aims to establish the available evidence & literature on the subject with emphasis on identifying knowledge
gaps needing attention.

c) Refining the research question and developing key objectives.

This is based on findings of this initial reading. By now thoughts around study design and proposed
methodology can be outlined. The student should discuss with the supervisors to ensure appropriateness of the
research question(s) and objectives.

d) Structure of the proposal concept paper (5 - 10 pages)

o Brief background (introduction) & Review of literature.
o Study justification / Study Utility – This gives summary points on what the problem is, and why
the intended research is useful
o Research question(s), Study objectives
o Study Design and Study Setting
o Methods – Study population, case definitions, sample size & sampling, study procedures / data
collection procedures, data management and analysis, ethical issues

As you develop the proposal concept, especially the research questions and study objectives, discuss with your
supervisor(s).

e) Presentation of your research concept to panel of faculty

• You should now develop your concept outline into a 15 minute powerpoint presentation.
• The sub-headings given in section (d) provide the slide headings for conversion of your research
concept into a power point presentation.
• You will defend your research concept to a wider panel of faculty of your parent department, and
receive comments for improvement, and a decision of approval or non-approval to proceed with the
research project.

Clinical Research Proposal Writing Guideline. Prepared by Prof F Were 2014, updated by Prof E Maleche-Obimbo, UoNairobi. 2022 1
 GUIDELINES FOR FULL PROPOSAL WRITE-UP

Once you have presented the research concept to faculty and have approval to proceed with developing it into a
full proposal, you should expand the proposal write up to fit the following guideline.

a) Introduction (0.5-1.0 pages)

Introduction to the research subject may cover the following;
i. Definitions,
ii. Disease classifications,
iii. Brief epidemiology,
iv. Brief statement of the problem

b) Literature review (5-10 pages).

This is based on review of available literature (publications, case studies, guidelines etc) relevant to the
research question(s) and objective(s). It may include:
i. Focused literature review involving; Selection of key articles/publications appropriate to each objective.
Description of their findings in adequate details including methodology while critically relating these findings
to the expectations of the intended study
ii. Quotations should focus on the most methodologically powerful and relevant studies for detailed quotation.
The other studies should be referenced as additional reports for/or against the present arguments

Tables and illustrations are a useful way of summarising information and are encouraged.

c) Study Justification/Utility (up to half a page)

Study justification involves building an argument to make the study valuable to the available body of science.
This section should include:
• Statement of the problem(s) that prompted the research question
• How the information generated will benefit humanity (e.g new knowledge, guide policy, guidelines or
practice).

d) Research Question & Study Objectives

Decide on the research question, or research questions – these arise from the problem that you identified that
you wish to investigate and gain better insight into.

Break the research questions into study objectives, each objective will evaluate a distinct sub-section of the
problem. Principles of developing easy to evaluate objectives based on the SMART.

i. Specific (the prevalence of preterm deliveries rather than evaluation of prematurity)

ii. Measurable (Determine/estimate Proportion rather than describe/measure the magnitude)
iii. Appropriate (determine associated factors using a case controlled not simple descriptive study)
iv. Realistic (determine the prevalence of PEM among children admitted to KNH rather than the incidence of
PEM in Kenya)
v. Time-bound (Prevalence of MAS in KNH NBU not incidence of MAC in the KNH birth cohort of 2014-should
be achievable in the time available to student)

Clinical Research Proposal Writing Guideline. Prepared by Prof F Were 2014, updated by Prof E Maleche-Obimbo, UoNairobi. 2022 2
 Overall objective:
Refers to an over-arching objective statement that encompasses all the objectives (primary and secondary
objectives) in one summary objective statement. (e.g. To determine the prevalence and factors associated with
disease x). The term “Broad objective” is also appropriate and preferred by some institutions.

Specific Objectives:
The overall study objective may then be further broken down into specific objectives as follows:

Primary objective(s) – which addresses the main question of interest. The sample size shall be computed to
ensure there is adequate numbers of study subjects to have statistical power to answer this objective. (e.g. to
determine the prevalence of disease x)
Secondary objective(s) - additional objectives can be included to answer additional questions of interest, but for
which the sample size may not be large enough to answer conclusively. E.g. (to determine the predictors of
disease x, factors associated with outcome y)

e) Methods

i. Study Design
It is of utmost importance to use an appropriate design for a study. This choice is determined by the study
question and objectives. The following table indicates appropriate choices for a short research project:
• Cross-sectional survey
• Clinical audit
• Prospective Cohort study (with short follow-up period)
• Retrospective Cohort study (e.g. medical records abstraction)
• Case control study

All of the above study designs can be conducted using review of medical records / medical record abstraction, or
using a combination of interview, examination, observation and medical record abstraction.

i. Study Area / Setting

Describe the general geographical, socioeconomic and environmental setting in which the study will occur.
This may include describing the town/city or community, and general health indices of the population,
general economic status and major economic activities, environmental issues – as relevant to the specific
study.

ii. Study Site

Describe the health facility in which the study will take place for hospital based studies – e.g. level of health
facility, patient volumes, staffing, physical infrastructure. For community based studies describe the specific
community or village where the subjects will be enrolled.

iii. Study Population

Key elements of describing the study population include:

a. Inclusion criteria
List the attributes that a participant must have to be eligible to be enrolled in the study. Common
aspects include:

Clinical Research Proposal Writing Guideline. Prepared by Prof F Were 2014, updated by Prof E Maleche-Obimbo, UoNairobi. 2022 3
 • Have the disease of interest
• Age range
• Receive care in the study facility
b. Exclusion criteria
If an individual fulfils the inclusion criteria, if there are any specific attributes that make them
unsuitable for the study, these are called exclusion criteria. Common exclusion criteria include:
• Have a disease that mimics (has similar symptoms/signs) the disease of interest (e.g.
congenital heart disease, when are studying rheumatic heart disease)
• No parent available to give consent
• Missing key outcome or risk factor data (especially for studies relying on medical records
abstraction)

iv. Case definitions / Definitions of Key exposures and outcomes

• Give a clear case definition for the specific disease of interest – how you will define a patient as having the
disease in this study. The disease could be main inclusion criteria, or a risk factor, or an outcome depending
on your study question.
• Key exposures or risk factors of interest should be defined (in data section these are termed as dependent
or predictor variables).
• Key outcomes of interest need to be specifically stated (in data section these are termed as independent
variables).
• These definitions will guide what variables you collect in your case record form, to enable you accurately
classify each study subject for the key exposure or outcome of interest.

v. Sample Size Calculation

This is determined by the design which is itself driven by the primary objective(s). When more than one such
objective is understudy, each must have a sample size calculated and the highest number of subjects used to
represent all the objectives. Secondary objectives do not need individual sample size calculation

vi. Sampling methods

A detailed description of how each subject will be recruited into the study (sequential or random) into the study
and where appropriate be assigned different arms of the study. For medical record abstraction, describe how
records will be identified and sampled.

vii. Study tools – Data Collection tools

These include case record forms (CRFs), questionnaires, interview guides etc. Describe the tools and give brief
summary of the key variables / information that will be collected using the tool.
The full CRF or other tool should be attached in the appendices.
Data collection methods to consider:
• Quantitative data preferred for short research project which can be analysed using simple statistical
approaches
• Qualitative data can be obtained, but limit number of focus groups (e.g. 2) and / or in depth interviews /
key informant interviews (5 max) as data analysis requires much more time.
• A combination of quantitative data, enhanced by strategically chosen quantitative data collection can be
attempted (mixed methods).

viii. Study Procedures (Data collection procedures)

Clinical Research Proposal Writing Guideline. Prepared by Prof F Were 2014, updated by Prof E Maleche-Obimbo, UoNairobi. 2022 4
 These include; Step by step description of process of executing the study, of enrolling patients and obtaining
data; describe “the who, when, where and how the required data will be obtained”.
Specify which types of data you will capture for your study: quantitative” or “qualitative” data, or a mixed method
approach (both quantitative or qualitative data).
• Describe research assistants / who will collect the data, and training that will be given.
• Screening and enrolment procedures: Details of how patients / patient records will be screened to determine
eligibility, how to confirm case, how key variable data will be obtained. Where and when this will be done.
• The procedure for obtaining consent should be described (where applicable).
• Clinical data collection methods employed including physical examination, biophysical measurements and
collection and transport of biological specimens should also be detailed.
• Laboratory methods require detailed description including quality control measures. Where it is very long it
should be attached as a separate section or as an appendix.
• Qualitative methods should be described in adequate details – selection of foccussed group discussion
(FGD) groups or key persons for in-depth interviews, composition of groups, interview methods and tools,
methods of capturing narrative discussions (recording, writing notes etc).

ix. Data management

This involves a detailed description of how the data will be computerised, cleaned, secured etc.

x. Data analysis
Describe how data will be analysed to:
• describe the study population (descriptive characteristics). State how data of relevant variables are
summarised – e.g. median (IQR), or mean (SD), grouping into categories.
• provide results corresponding to each study objective (prevalence, proportions, associations, odds ratio,
relative risk, significance level, common themes etc).
• can describe briefly how data results will be presented (can prepare dummy tables and/or graphs).
• If qualitative data is collected (e.g. focussed discussion groups, key person in-depth interviews), give
summary of how the qualitative data will be organised and interpreted.

xi. Ethical Considerations

• Ethical approval from UoN/KNH ethical review committee
• Approval from the hospital management / institution management for research outside KNH
• Risks and benefits to patient, safety, justice, beneficence.
• Voluntary nature – informed consent.
• Confidentiality, security of patient information

xii. Study Strengths and Limitations

Mention any strengths in your study
Mention any limitations

xiii. Study Timelines

Prepare timeline for each stage of the research. E.g. Proposal development month 1-4, Regulatory
approvals month 4-5, Data collection months 6-8, Data analysis month … etc
May use Ganntz Chart

xiv. Study Budget

Rough outline of itemised costs of the project (personelle, questionnaires, lab tests, etc)

xv. References

Clinical Research Proposal Writing Guideline. Prepared by Prof F Were 2014, updated by Prof E Maleche-Obimbo, UoNairobi. 2022 5
 Vancouver style referencing recommended.
Authors. Title. Journal. Date; volume (issue): page numbers…

Example.
Njuguna IN, Cranmer LM, Wagner AD, LaCourse SM, Mugo C, Benki-Nugent S, Richardson BA,
Stern J, Maleche-Obimbo E, Wamalwa DC, John-Stewart G. Brief Report: Cofactors of Mortality
Among Hospitalized HIV-Infected Children Initiating Antiretroviral Therapy in Kenya. J Acquir Immune
Defic Syndr. 2019 Jun 1;81(2):138-144. doi: 10.1097/QAI.0000000000002012. PMID: 31095004;
PMCID: PMC6609091.

xvi. Appendices
Consent forms, assent forms, case record forms, lab record forms, etc.

Clinical Research Proposal Writing Guideline. Prepared by Prof F Were 2014, updated by Prof E Maleche-Obimbo, UoNairobi. 2022 6