This document provides an overview of various clinical trial reporting guidelines developed by the EQUATOR Network, including CONSORT for randomized controlled trials, STROBE for observational studies, PRISMA for systematic reviews/meta-analyses, and ARRIVE and CARE for animal and case studies respectively. It discusses the goals of the EQUATOR Network, describes the development and components of these guidelines, and reviews evidence on their impact in improving the quality and transparency of research reporting over time, though adoption remains incomplete.

1. Dr. Avishek Amar
Junior Resident
Subject Review
29/04/2017
REPORTING GUIDELINES
&
THEIR IMPACT :
HOW FAR, HOW GOOD ?

2. OVERVIEW
• Introduction
• EQUATOR Network
• CONSORT Guidelines
• ARRIVE Guidelines
• STROBE Guidelines
• PRISMA Guidelines

3. OVERVIEW – CONTINUED…
• CARE Guidelines
• Other Important Guidelines
• Guidelines & Their Impact
• Guidelines in the pipeline
• Summary
• Conclusion

4. INTRODUCTION
• Quality of reporting of a study : very important
• Critical appraisal
• Findings of a study to be propagated further
• Guidelines bring a sense of uniformity &
transparency

5. INTRODUCTION – CONTD…
• Lot of evidence available regarding bias in
clinical trials
• Most of the research results avoid sharing
vital information
• Guidelines – Expectations from researchers
under various headings

6. Enhancing the QUAlity
and
Transparency Of health Research

7. THE EQUATOR NETWORK
• Came into existence in June 2008
• An umbrella organisation for all kinds of
healthcare research
• Involved in developing robust guidelines and
updating the existing ones.

8. THE EQUATOR NETWORK – CONTD…
• Comprises of experts like journal editors,
peer reviewers, statisticians etc.
• Presently 358 guidelines available related to
healthcare research
• Some guidelines are available in as many as
16 languages
• Endorsed by reputed journals like The
Lancet, BMJ, PLOS Medicine etc.

9. EQUATOR NETWORK – 7 GOALS
1. Development of robust guidelines
2. Digital centre for resource sharing
3. Promotion of guidelines to people who matter
4. Periodic assessment of journals

10. EQUATOR NETWORK – GOALS CONTD…
5. Periodic audit regarding the reporting quality
6. Set up EQUATOR collaborating centres all
over the world
7. Action plan to translate the findings of the
research to actual practice.

11. DECISION TREE

12. Consolidated Standards of Reporting Trials

13. CONSORT GUIDELINES
• Work started in this direction in 1993
• Group of experts came up with a list of 32 items
• Known as Standardized Reporting of Trials
(SORT)
• In 1996, finally CONSORT took shape

14. CONSORT CONTD…
• It has undergone few updates since then in
2001 and 2010
• The one in use presently has 25 items in the
checklist.

15. CONSORT CHECKLIST
• Title & Abstract : Identified as “randomised” for
better indexing, summary of design, methods &
results
• Introduction about the topic, available knowledge
& objectives

16. CONSORT CHECKLIST CONTD…
Methods
• Trial design, settings & eligibility criteria’s
• Interventions & Outcomes
• Sample Size Estimation

17. CONSORT CHECKLIST CONTD…
Methods
• Randomisation
• Blinding
• Statistical Methods

18. CONSORT CHECKLIST CONTD…
Results
• Participant flow
• Baseline data
• Numbers Analysed
• Outcomes
• Data regarding adverse effects

19. CONSORT FLOW DIAGRAM
Enrollment
Allocation
Follow-Up
Analysis

20. CONSORT CHECKLIST CONTD…
• Discussion and other Information
• Limitations
• Generalizability & Interpretation
• Details about registration & funding

21. CONSORT EXTENSIONS
• Based on design of the study
• Based on type of Intervention
• Based on type of data analysed

22. Animal Research : Reporting of In Vivo Experiments

23. ARRIVE GUIDELINES
• Developed by National Centre for the
Replacement Refinement and Reduction of
Animals in research (NC3Rs)
• In 2009 analysis of 271 studies showed only 60%
of studies mentioning the details about age, sex &
weight of the animal.
• Mostly lacked information about strain & sex

24. ARRIVE GUIDELINES- CONTD…
• Guidelines developed under 20 headings
• Provide information about design of study, animal
details, housing conditions & statistical methods
• Aim to prevent animal experiments not necessary.
• By 2011, were endorsed by about 40 journals

25. ARRIVE GUIDELINES- CONTD…
• Broadly categorised under 6 headings
• Title : describing the study & abstract providing
notable findings.
• Introduction : background & objective of study
• Information about sex & strain of animal, housing,
statistical methods, sample size calculation

26. ARRIVE GUIDELINES- CONTD…
• Results must have baseline data, adverse events
& outcome
• In the end discussion about the possible
implication and interpretation
• Generalizability to humans or other species.
• Information on funding

27. Strengthening the Reporting
of
Observational Studies in Epidemiology

28. STROBE
• 90% of research in clinical field : Observational
• Inspired by CONSORT
• In 2004, 3 working groups, editorial staff of
journals like BMJ, Annals of Internal Medicine,
JAMA, The Lancet

29. STROBE
• Comprises of 22 checkpoints
• Out of 22 items, 18 items common to all 3 study
designs, remaining 4 (Item 6,12,14,15) specific to
design they were catering to

30. STROBE - EXTENSIONS
• 13 extensions available
• STrengthening the reporting of Genetic
Association Studies - STREGA
• The REporting of studies Conducted using
Observational Routinely-collected health Data
RECORD

31. STROBE CHECKLIST
• Title & Abstract : Reflective of the design of the
study, abstract should bear vital information
• Introduction : Rationale and objectives of study
• If the study tries to plug any gaps in the existing
level of knowledge it should be stated clearly.

32. STROBE CHECKLIST
Methods
• Design & Setting of study
• Time points rather than duration
• Participants recruitment sources and their
eligibility criteria’s.
• Methods of follow up, preferably same for all
• Cases & controls should be interviewed randomly

33. STROBE CHECKLIST
• Sample size estimation and statistical analysis to
be mentioned.
• Any subgroup analysis done to be mentioned
• Explanation about missing data management

34. STROBE CHECKLIST
Results:
• Information about dropouts with reason.
• Demographic details & comorbid conditions
• Category boundaries, if used for continuous data,
• limitations of the study
• Generalizability.

35. Preferred Reporting Items
for
Systematic Reviews & Meta-Analyses

36. PRISMA GUIDELINES
• Meta-analysis - top tier on evidence pyramid.
• Systematic review held in high regard as it
summarises, compares and contrasts the
findings of several trials done
• In 1999 -QUOROM (Quality of Reporting of
Meta-Analyses) was introduced

37. PRISMA GUIDELINES
• Updated version of this developed by group of
authors and journal editors in 2005
• PRISMA- 27 checklist items & a flow diagram
with 4 phases

38. PRISMA CHECKLIST
• Title should include “systematic review or
meta-analysis”.
• PICOS approach should be preferred
• Abstract should highlight the salient points of
the study

39. PRISMA CHECKLIST-CONTD…
• Introduction : description of rationale of the review
• Allows readers to know if it is an update of existing
knowledge or on a new topic.

40. PRISMA CHECKLIST-CONTD…
Methods
• Protocol with registration number required.
• Any modification in protocol.
• Source of information : Online database or
direct contact with the author
• Starting and ending date of database search

41. PRISMA CHECKLIST-CONTD…
• Results :Number of studies screened and
included in the review should be mentioned.
• Summary of data from each contributing
study to be provided
• Additional analysis done should be included
in discussion.

42. PRISMA FLOW DIAGRAM
Identification
Screening
Eligibility
Included

43. CAse REport

44. CARE GUIDELINES
• Case reports mainly relate with unexpected
or rarely appearing event.
• Lack statistical evidence, thus not much
valued
• Helpful when a new or rare adverse effect of
a drug seen
• Introduced in 2013, consists of 13 items

45. CARE CHECKLIST
• Title should have “Case Report” mentioned in it
• Followed by keywords, facilitating easy search
• Introduction should deal with the uniqueness of
the condition
• Patient identity should not be revealed

46. CARE CHECKLIST- CONTD…
• Methods used for diagnosis and the reason
should be discussed.
• Any intervention provided deserves due mention
• Discussion about the condition with laboratory
values and clinical findings needed.
• Patients informed consent and perspective
about their condition to be taken

47. CARE EXTENSIONS
• Presently 2 extensions available
- SCARE (Surgical Case Report)
- HOM-CASE (Homeopathic Case Report)

48. OTHER IMPORTANT GUIDELINES
• Standards for Reporting Diagnostic Accuracy
Studies – STARD
• Enhancing transparency in reporting the
synthesis of qualitative research- ENTREQ
• REporting recommendations for tumour MARKer
prognostic studies – REMARK
• Standard Protocol Items: Recommendations for
Interventional Trials – SPIRIT

49. GUIDELINES & THEIR IMPACT
• 2010 study, RCTs (NEJM, The Lancet, JAMA )
• 271 research works assessed.
ITEM % Reported
“RANDOMISED” 58.7%
Eligibility criteria & setting 61%
Adverse Effect Information 43%
Allocation concealment details 11.8%
Blinding details 21%

50. GUIDELINES & THEIR IMPACT- CONTD..
• Impact of CONSORT guidelines in psychiatry
• 442 RCTs from 7 high impact journals assessed
• Failure to provide details about allocation
concealment decreased to 55% from 85%
Checklist items Pre CONSORT Post CONSORT
100% - 04%
75-99% 11% 56%
50-74% 68% 39%

51. GUIDELINES & THEIR IMPACT- CONTD..
• Dermatology journals from 2004-2010
• 5 year impact factor of ≥4
• 22 strobe checklist items assessed for number
of journals reporting them
Checklist Item Reported %
Outcome data, objectives of the study >80%
Sample size calculation details 4.5%
Statistical methods 16%

52. GUIDELINES & THEIR IMPACT- CONTD..
• In 2014, study done on public health journals
publishing studies done between 2010-2013
Guideline Followed
STROBE 0.4%
PRISMA 11%
CONSORT 13,6%

53. GUIDELINES & THEIR IMPACT- CONTD..
• Journals too are equally responsible for not
endorsing these guidelines strictly enough
• Study on 69 indexed journals of paediatrics, 2011
- Only 3% of journals endorsed STROBE
- 14% endorsed CONSORT
Branch Endorsing PRISMA
Anaesthesia journals 27%
Gastroenterology journals 12.9%

54. GUIDELINES & THEIR IMPACT- CONTD..
• In 2014, articles on animal studies were
evaluated under 4 headings: ethics,
randomisation, animal details like species,
age, sex and sample size estimation.
Heading PLOS Nature
ethical guidelines 94% 100%
animal species 100% 100%
sex of the animals 68% 79%
Randomisation Detail 10% 0%
Sample Size Estimation Details 0% 7%

55. GUIDELINES IN THE PIPELINE
• More than 40 guidelines under development
• CONSORT-SPI
• CONSORT-C
• PRISMA-C
• Instrument for the Selection of Primary
Endpoints in Clinical Trials (InSPECT)

56. SUMMARY
• Guidelines form an important part of research
reporting
• EQUATOR network has done a commendable job
• CONSORT has definitely improved reporting of
RCTs

57. SUMMARY
• Overall impact not satisfactory
• Other guidelines too can help improve, if
adopted seriously
• Separate guidelines pertaining to child
research are under development

58. CONCLUSION
• Implementation of guidelines : Major resort to
generate reliable results
• Agencies involved are trying to do their job
• Improvement seen is not satisfactory
• Journals need to implement them strictly
• Researchers need to correct their shortcomings