The document provides guidance on components that should be included in a research report. It discusses preliminary parts such as the title, acknowledgements, and abstract. It describes the body of the report which includes an introduction describing the topic and importance of the study, statement of the problem, literature review, significance and objectives of the study. The method section outlines the study design, period, population, data collection and analysis. The results, discussion, limitations and conclusions/recommendations are also highlighted as important components to include to effectively communicate the study findings.

1. Sample Size Determination
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Research Methodology

2. Sample Size Determination
• In planning any investigation, we must decide how many people need to be
studied in order to answer the study objectives.
• If too large
 Unnecessary waste of the limited resources
Data collection, analysis
• If too small
 Cannot assure sufficient power for the detection of meaningful estimate
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3. Con’t…
• The eventual sample size is usually a compromise between what is desirable
and what is feasible.
• In order to calculate the required sample size, you need to know the following
facts:
 The reasonable estimate of the key proportion to be studied. If you cannot
guess the proportion, take it as 50%.
 The degree of accuracy required
 The confidence level required, usually specified as 95%
 The size of the population that the sample is to represent
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4. Con’t…
a) Estimating a Single population mean
n =
Where :
n- sample size , z – confidence coefficient
d- desired precision = variance (Std Dve)
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5. Con’t…
• E.g. Mr. X wishes to estimate mean hemoglobin level in a
defined community. From preliminary contact he thinks the mean
is about 150mg/l with a standard deviation of 32mg/l. If he is
willing to tolerate a sampling error up to 5mg/l in his estimate,
how many subjects should be included in his study? (α =5%, two
sided)
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6. Con’t…
Given Z =1.96
Std.Dev =32 mg/l
d =5 mg/l
Required = n
n =
=
≈ 158 persons
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7. Con’t…
b) Estimating sample in single population proportion
• Estimates how big the proportion might be (P)
n =
Where q= 1-p
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8. Con’t…
• Example : A survey is being planned to determine what
proportion of families in a certain area are medically indigent. It
is believed that the proportion can not be greater than 0.35. A
95% confidence interval is desired with d = 0.05. What sample
size of families should be selected?
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9. Con’t…
• Given n = ?
p = 0.35 , q = 0.65
z = 1.96
d = 0.5
n =
=
≈ 350
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10. Con’t…
• If N (entire population) is less than 10, 000, the required sample size will be smaller.
 2. If n/N>5%
 In such cases, calculate the final sample estimate nf by using the following formula.
nf =
 Where nf =desired sample size (with population < 10,000)
 n=desired sample size (when population > 10,000)
 N=the estimate of the population size
• E.g. If n where found to be 400 and if the population size were estimated as 2000,
then
nf =400/1+(400/2000) =286
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11. Health Research Ethics
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12. Historical Perspectives
• Scientific research has no doubt contributed a lot to the development of
our world.
 Health research has played a significant role in minimizing the burden of
various diseases.
• At the same time it has also raised ethical questions.
• Public attention was drawn to ethical questions by reported abuses of
human participants in biomedical experiments especially during the
Second World War.
 Since then ethics has become an evolving issue which has drawn global
attention.
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13. Con’t…
 Nazi War Crimes
• Prior to and during the World War II (1940s), Nazi physicians and
scientists conducted experiments on concentration camp prisoners
without their consent.
• Many of these experiments involved exposing subjects to extreme
suffering for observational purposes such as:
To determine the time to death for individuals submerged in freezing
water
To determine the ability of subjects to risist high altitude conditions
by forcing them into low-pressure chambers
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14. Con’t…
• The Nazi experiment involved sterilization of subjects & exposing
them to malaria, poisons, typhus, untested drugs & operations
usually without any form of anesthesia.
• The Nazi experiments violated numerous rights of human research
subjects :
The selection of study subjects was racially based
demonstrating unfair selection process
The subjects has no opportunity to refuse participation –
prisoners
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15. Con’t…
• During the Nuremberg Military tribunals/court of justice at the end of
World War II,
the scientists who conducted these experiments were held
accountable for their actions
 The Nuremberg Code (1947)
• The 10 principles outlined in Nuremberg Code were among the 1st rules
for experimentation involving human subjects
 The first and most famous principle from this historic code states “the
voluntary consent of the human subject is absolutely essential”
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16. Con’t…
 The Tuskegee Syphilis Study
• In 1932 the U.S Public Health Service (PHS) began a study of the
natural course of untreated syphilis among rural black males in Macon
Country, Alabama
• About 400 men with syphilis and 200 uninfected controls were enrolled
in the study
• Informed consent was not obtained from study participants
• Study procedures such as spinal taps were represented as “free
treatment”
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17. Con’t…
• This study was halted in 1972 when national press reports prompted public
outrage
 This was the longest non-therapeutic experiment on human beings in
medical history
By the time the study was stopped
Dozens of the participants had died of syphilis
Many of their wives had been infected
Many of their children had been born with congenital syphilis
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18. Con’t…
 The Belmont Report
• In 1972, the public became aware of the Tuskegee study
 As a result, in 1974 the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research was established.
• In 1978, the commission submitted its report titled, ‘The Belmont
Report’
 Ethical Principles and Guidelines for the Protection of Human Subjects of
Research.
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19. Con’t…
 Willow brook study
• An institution for mentally retarded at willow brook conducted a
research on hepatitis on children from mid 1950s to early 1970s
• The subjects, all children, were deliberately infected with hepatitis virus
• To gain their child’s admission to institution, parents were forced to
give permission for the child to be a subject in the study
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20. Con’t…
 The declaration of Helsinki (1964)
• Was adopted by the World Medical Association in 1964 to guide application
of the ethical principles for clinical research.
 Other international guidelines
A) International Guidelines for Biomedical Research Involving Human
Subjects
B) B) International Conference on Harmonization (ICH)
C) International Guidelines for the Ethical Review of Epidemiologic Studies
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21. Ethical principles
• Before you embark on research with human subjects, you are likely to
require ethical approval.
 Autonomy- we ought to respect the right to self-determination
• Autonomy is protected by ensuring that any consent to participate in
the study is informed or real.
There must be no coercion of any sort.
 Non-Maleficence- we ought to ‘do no harm’
• This principle states that we may not inflict harm on or expose people to
unnecessary risk as a result of our research project.
This is particularly important if our subjects may not be competent
in some way
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22. Con’t…
 Beneficence – we ought to further others’ legitimate interests
• The principle is to maximize benefits and minimize harms and wrongs
Making efforts to secure the well-being of research participants
Justice-we ought to ensure fair entitlement to resources
• People should be treated equally in every way
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23. Con’t…
 Veracity
• All subjects in any research project should always be told the truth.
There is no justification for lying
 Privacy
• When subjects enroll in a research study, they grant access to
themselves
Includes viewing, touch or having information about them
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24. Con’t…
 Confidentiality
• No information obtained with the subject’s permission from their
medical records should be disclosed to any third person without that
individual’s consent.
 Fidelity
• Keeping our promises and avoiding negligence with information.
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25. Research Report Writing
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26. Research Report
• A written document or oral presentation of the
evidence and the findings in such a detail and form as
to be readily understood and accessed by the reader
and as to enable him to verify the validity of the
conclusions.
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27. Con’t…
Why it is important?
• To share Knowledge and innovative findings
• To show gaps that need further investigation
• To convey others about the issue of interest
• To provide input for decision makers during
 Policy formulation, Planning, Intervention
 Monitoring and Evaluation
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28. Components of Research Report Document
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29. Preliminary parts
 Title
• Indicate study subjects, study design, study area, objective of the study
and study period
 Identify the main issue of the paper
 Begin with the subject of the paper
 Not more than 20 words
 It should not contain abbreviations
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30. Con’t…
 Acknowledgement
• We should acknowledge individuals, communities and organization such
as study participants, funding agents, advisors, data sources and others
accordingly
• It usually placed right after the title page or at the end of the report,
before the references
• Acknowledgement shouldn’t exceed 100 words
• Acknowledge in the order of General to Specific (community to individual)
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31. Body of the report
 Abstract
• It should contain
Avery brief description of the problem (WHAT)
The main objectives (WHY)
The place of study (WHERE)
The type of study and methods used (HOW)
Major findings and conclusions
• Word length on average 150-250
• Generally written in the past tense and should not contain
abbreviations or acronyms unless standard or very well
known.
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32. Con’t…
 Introduction
• It tells the reader that
What the topic of the paper is
Why the topic is important
What to expect in the paper
It should funnel from general ideas to the specific topic of the paper
In 3-4 paragraphs
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33. Con’t…
 Statement of the problem
Try to briefly discuss what is known in the area and the gap that
should be filled by your research.
It describes the context of the study and identify the general
analysis approach of study
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34. Con’t…
• We have to address the following issues when we write this section
Size and distribution of the problem
Major factors that influence the problem
Solutions that have been tried in the past
How well the solutions worked
Why further research is needed
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35. Con’t…
 Literature review
• Search widely which are most relevant and recent literatures
• Put reference for all reviewed literature
• Include information directly relevant to your study
• There should be logical sequence in writing literature review
• Put in the order of global to local context of the condition in precise
manner
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36. Con’t…
 Significance of the study
• It indicate how your research will affect existing knowledge in the area
under investigation.
• Talk about implications, how results of the study may affect scholarly
research, theory, practice, educational interventions, curricula,
counseling and policy.
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37. Con’t…
 Objective
• State both the general and specific objectives clearly
• General objective: aim of the study in general terms
• Specific objectives: measurable statements on the specific questions to be
answered
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38. Con’t…
 Method
• Study design
 Clearly states (qualitative, quantitative, or both)
 Which specific type from each design should be stated
• Study period and area
Indicate location of the study area, socio demographic information,
the health care system
Brief description of the socio-economic & cultural characteristics.
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39. Con’t…
• Source and study population
Define the source population where you haven taken study
population
State the parameters for inclusion and exclusion
Reflection on adequacy and strength of sample and variables for
generalizing to the target population
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40. Con’t…
• Data collection methods
Consider both qualitative and quantitative data collection
techniques based on your design and objective.
Describe about data collectors, procedures, number of
days, data collection tools and technique.
• Ethical consideration
State about the respective reviewing ethical board
committees, consent from local authority and the way to
assure informed consent of study participant.
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41. Con’t…
 Data processing and analysis
It is essential that the statistical methods to be used in the
investigation are outlined in detail.
The techniques that will be used to test your hypotheses or
research questions
Manipulations of the variables or data
It is not sufficient to merely state the names of the tests
to be used;
You should describe the rationale for your choice of statistical
software package.
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42. Con’t…
 Quality assurance
 Mentioning the way of quality assuring means such as training
of data collector, pretesting, ongoing supervision of data
collector, cross checking etc.
 Operational definitions
Define the variables to be observed in the context of your
research
 Plan for Dissemination and Utilization of the findings
 State the way of communication to the respective audience and
the way for utilization of the findings
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43. Con’t…
 Result
• The results section chronicles the findings of the
statistical analyses and assesses whether your
expectations (hypotheses) were correct.
• Statements about new discoveries or surprises encountered in
the analyses
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44. Con’t…
 Discussion
• You should summarize the most salient points of your
research (tell the reader what you found out about your
topic).
• Discuss the general significance of your topic and
findings.
• Discuss things future researchers should investigate about
your topic.
• The discussion may include findings from other related
studies that support or contradict your own.
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45. Con’t…
 Limitation of the Study
• State the limitation of your study and other problems that encountered during your study
 Conclusions
• Should follow logically from the discussion of the findings.
 Recommendations
• The recommendations may be summarized according to the groups towards which they are directed, for
example:
 Policy-makers,
 Health and health-related staff who could implement the activities,
 Potential clients, and
 The community at large
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46. Supplementary material
 Citation of References
• References are useful to illustrate facts
 Appendix
• Biographical data of the principal investigator
• The study questionnaire if you have it
• The consent form
• Map of the study area
• Analysis output tables and others
• A copy of the approval from the Review Board & if available from
ethical clearing bodies
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