1. Reporting the observational
studies

2. Writing a journal article
• There is no standard or uniform style that is
followed by all journals
• Each journal has its own style; but they all
have their own Instructions to Authors
• Select a journal - FOLLOW THE JOURNAL’S
INSTRUCTIONS TO AUTHORS

3. Reporting observation study
• Two guidelines
–IMRaD
–STROBE statement

4. 4Grimes, DA, Schulz KF. An overview of clinical research:
the lay of the land. Lancet 2002; 359; 57-61.
IMRaD /
STROBE

5. The IMRaD Research Paper Format
• Introduction, Methods, Research [and] Discussion
• A mnemonic for a common format used for
academic ['scientific'] research papers
• IMRaD is simply a more 'defined' version of the "IBC"
[Introduction, Body, Conclusion] format used for all
academic writing
• Considered ideal outline in early 1990s
• Late 1970s, International Committee of Medical
Journal Editors (“Vancouver Group”) first published
guidelines

6. Bradford Hills questions
• Introduction Why did you start?
• Methods What did you do?
• Results What did you find?
and
• Discussion What does it all mean?

7. Introduction (including a title)
• The title is centered at the top of the first page.
• Introductory section.
– Comprises one or several paragraphs which outline the
research question and its significance within the topic
being discussed, previous work on topic & gaps in
current knowledge, making it clear what the relevance /
rationale of the question and aim/objectives of the
study.
– Brief and arresting
– Define nature and scope of problem, but do not hide
inconvenient facts

8. Review of Background, 'Known
Information‘*
• [*This section is not part of the 'IMRAD'
mnemonic, as it is considered to be self-
evident]
• What? Who? Why? How?

9. Methods (1)
• Describe how you gathered the information.
• What events did you observe
• Who did you interview?
• Why did you interview these particular people? &
how you find them?
• What sort of information did you collect from them?
• If your paper includes interviews or surveys, here is
where you would describe their design, procedure,
analysis

10. Methods (2)
• Study design
• Setting
• Who is the study about?
– Participants and control subjects (in animal studies, specify
genus, species)
– Inclusion & exclusion criteria
• Sample size
• What did you do?
– Intervention or Follow up
• What did you look for? - Outcome measure

11. Methods (3)
• Interventions / test
– If standard, give reference
– If new or modified, provide details (sufficient for
reproduction by other workers)
– Timing and duration of intervention
– Equipment / kits / manufacturer
• Outcome
– Define outcome
– Parameters to assess outcome
– Endpoint, cut-off values
– Adverse events, if any e measures

12. Methods (4)
• Follow up
– Frequency, method, duration (including minimum
acceptable duration)
– Criteria for termination or drop-out
Per-protocol vs. intention-to-treat
• Analysis
– Methods used for different parameters •
– Software

13. Results (1)
• What did you find out from the method you had
employed?
• Here's where you would include your description of
the participants, main results
• Should answer all points raised in Methods
• No new parameters
• No miss-match between numbers in text and tables /
figures

14. Results (2)
• Participants
– How many screened?
– How many eligible?
– How many recruited / excluded?
– How many completed study?
– Reasons for lack of completeness
– Compliance with therapy / protocol
All subjects should be accounted for

15. Results (3)
• Data presentations
– Cause of incomplete data, if any (sample lost, incomplete
study)
– No repetition between text and tables
– No interpretation
– No adjectives (most, some, often..)
– Use % only if n>100
– Restrict decimal points to 1 or 2
– Provide value of p (“highly significant”, “very highly
significant” meaningles

16. Discussion
• What do the findings presented under "Results" above
mean? Specifically, how your findings prove your thesis?
• What patterns do you see in the data?
• How do they correlate with what had been 'known'
about the event, and/or what you had expected to find?
• Did you find what you had expected to, or were you
surprised? (Often the parts that surprised you are the
most significant, and the most interesting.)
• Is further research desirable? If so, what, and how?
Researchers often use this section to promote interest
(and funding) for their next research project.

17. Limitations
• Often a separate subdivision of discussion
• Viewed after the fact, what would you have done
differently (if you had been able to) to obtain more
objective and 'reliable' results?
• All research projects will have such "limitations":
– this does not diminish the findings or disproved
with the plan and material which was used;
– it simply recognizes that, had it been possible to
conduct the project differently the results could or
would have been different.

18. Conclusion, Notes, Works Cited and Appendices
• While the IMRAD format presumes the paper's conclusion
to be a subsection of the Discussion, there should be a
distinct closing to the paper of several paragraphs that
briefly summarize what the paper has proposed, discussed
and concluded.
• Following this would be (in MLA format) possible [author]
Notes, the paper's Works Cited, and possible Appendices.

19. STROBE
• STrengthening the Reporting of OBservational
studies in Epidemiology
• Guidance on how to report observational studies well
• The STROBE Statement is being endorsed by a growing
number of biomedical journals
• Published in Oct 2007
• 22 item checklist

20. Table 1.
Vandenbroucke JP, von Elm E, Altman DG, Gøtzsche PC, et al. (2007) Strengthening the Reporting of Observational Studies in Epidemiology
(STROBE): Explanation and Elaboration. PLoS Med 4(10): e297. doi:10.1371/journal.pmed.0040297
http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0040297

21. Recommendation
Title and abstract 1 a) Indicate the study’s design with a commonly used
term in the title or the abstract
b) Provide in the abstract an informative and balanced
summary of what was done and what was found
Introduction
Background and
rationale
2 Explain the scientific background and rationale for the
investigation being reported
Objectives 3 State specific objectives, including any prespecified
hypothesis
Methods
Study design 4 Present key elements of study design early in the
paper (what design, what was compared, which
controls and why...etc)
Settings 5 Describe the setting, locations, and relevant dates,
including periods of recruitment, exposure, follow-up,
and data collection

22. Recommendation
Methods (cont..)
Participants
6:
(a)
Cohort study - eligibility criteria, sources and methods
of participant selection, follow-up methods
Case control study - eligibility criteria, sources and
methods of case ascertainment and control, selection
rationale for the choices of cases and control
Cross-section study - eligibility criteria, sources and
methods of participant selection
6:
(b)
Cohort study - For matched studies, give matching
criteria and number of exposed and unexposed
Case control - For matched studies, give matching
criteria and the number of controls per case
Variables 7 Clearly define all outcomes, exposures, predictors,
potential confounders, and effect modifiers. Give
diagnostic criteria, if applicable

23. Recommendation
Methods (cont..)
Data sources /
measurement
8 For each variable of interest, give sources of data and
details of methods of assessment (measurement)
Give information separately for cases and controls in
case-control studies and, if applicable, for exposed and
unexposed in cohort and cross-sectional studies
Bias 9 Describe any efforts to address potential sources of bias
(ie systematic deviation of a result from the true value)
e.g.: recall bias, detection bias, interviewer bias, selection
bias
Study size 10 Explain how the study size was arrived at
(should be large enough to arrive at a point estimate
with a reasonably narrow confidence interval)

24. Recommendation
Methods (cont..)
Quantitative
variables
11 Explain how quantitative variables were handled in the
analyses.
If applicable, describe which groupings were chosen and
why
Statistical
methods
12 a) Describe all statistical methods, including those used
to control confounding
b) Describe any methods used to examine subgroups
and interactions
c) Explain how missing data were addressed
d) Cohort study: if applicable, explain how loss to
follow-up was addressed
Case-control: if applicable, explain how matching of
cases and controls was addressed
Cross-sectional: if applicable, describe analytical
methods including sampling strategy
e) Describe any sensitivity analyses

25. Recommendation
Results
Participants 13 a) Report numbers of individuals at each stage of study -
e.g., numbers potentially eligible, examined for eligibility,
confirmed eligible, included in the study, completing
follow-up, and analysed
b) Give reasons for non-participation at each stage
c) Consider use of a flow diagram
* Give information separately for cases and controls in case-control
studies and, if applicable, for exposed and unexposed in cohort and
cross-sectional studies
Descriptive
data
14 a) Give characteristics of study participants (e.g.
demographic, clinical, social) and information on
exposures and potential confounders
b) Indicate number of participants with missing data for
each variable of interest
c) Cohort study: Summarise follow up time (e.g. average
and total amount)
Separate for Case – Controls & Exposed – Unexposed

26. Recommendation
Results (cont)
Outcome
data
15 Cohort study: Report numbers of outcome events or
summary measures over time
Case-control: Report numbers in each exposure category, or
summary measures of exposure
Cross-sectional: Report number of outcome events or
summary measures
Separate for Case – Controls & Exposed – Unexposed
Main results 16 a) Give unadjusted estimates and, if applicable,
confounder- adjusted estimates and their precision (e.g.
95%CI). Make clear which confounders were adjusted
for and why they were included
b) Report category boundaries when continuous variables
were categorised
c) If relevant, consider translating estimates of relative
risk into absolute risk for a meaningful time period

27. Recommendation
Results (cont)
Other analysis 17 Report other analyses done, e.g. analyses of subgroups
and interactions, and sensitivity analyses
Discussion
Key results 18 Summarize key results with reference to study objectives
Limitations 19 Discuss limitations of the study, taking into account
sources of potential bias or imprecision.
Discuss both direction and magnitude of any potential bias
Interpretation 20 Give a cautious overall interpretation of results
considering objectives, limitations, multiplicity of
analyses, results from similar studies, and other relevant
evidence
Generalisability 21 Discuss the generalisability (external validity) of the study
results
Funding /other
information
22 Give the source of funding and the role of the funders for
the present study and, if applicable, for the original study
on which the present article is based

28. Three STROBE extensions (1)
• STREGA (2009)
– reporting of genetic association studies
28

29. Three STROBE extensions (2)
• STROBE – ME (Oct 2011)
– Reporting molecular epidemiology (biomarker
studies)
29

30. Three STROBE extensions (3)
• STROBE abstract
- Reporting observational studies in conference
abstracts (online draft)
30

31. More detailed explanation of strobe
Vandenbroucke JP, von Elm E, Altman DA, et al. Strengthening the
Reporting of Observational Studies in Epidemiology (STROBE):
Explanation and Elaboration. PLoS Med 4(10):
e297.doi:10.1371/journal.pmed.0040297
www.strobe-statement.org

32. Common mistakes

33. Introduction
• History starting from Adam
• Details of previous studies
• Abbreviations without full form
• Details of Results and Conclusions
• Intermix with Discussion

34. Methods and Results
• Mixed up
• Errors in data (e.g., mean age 25, range 17-22)
• Mismatch of data in Methods / Results /
Tables / Figures
• Misinterpretation of data

35. Discussion
• First study in the world / India / Maharashtra…
• Repeating results
• Emphasizing strengths of study over its weaknesses
• Inflating importance of findings
• Going beyond evidence and drawing unjustified
conclusions

36. This slide downloaded from a site hosted by Medknow for free
http://www.jpgmonline.com/wc_pdf/day1/1045_PA_IMRaD-3.pdf

37. • Thank you…