1. Reporting guidelines: current status
Representing CIHR, EQUATOR Network, and myself
Reporting guidelines: current status

2. Outline
A very brief look at reporting of health research
Reporting guidelines
EQUATOR Network
Challenges – the road ahead

3. Quality of reports of randomized trials
Conclusions Reporting of several important aspects of trial methods improved between 2000 and 2006; however, the quality of reporting remains well below an acceptable level
Hopewell, S et al. BMJ 2010; 340:c723

4. Differences in reporting of methodological items between CONSORT endorsing and non-endorsing journals in 2006
50% issue
Hopewell, S. et al. BMJ 2010;340:c723

5. Duff and colleagues examined 262 reports of randomized trials from the most prominent oncology journals.
They found that only 11% of the articles reported 10 essential items about the cancer interventions they studied, such as drug name and dose.
Duff et al. JNCI 2010; 102(10):702-5

6. Net effect
“This research investment should be protected from the avoidable waste of inadequately producing and reporting research”
Chalmers and Glasziou
“Thoughtful consideration of reporting trial-related procedures that could assist with turning “best evidence” to “best Practice” would be worthwhile”
“Careful and consistent reporting would help to promote safe and effective clinical application of oncology therapeutics ...”
Dancey
Systematic reviewers
The net effect is that clinicians are unable to take best evidence and translate it into best practice. Patients and other stakeholders are losing out on the best possible care.
Chalmers and Glasziou Lancet 2009;374:86-89; Dancey JNCI 2010; 102:

7. Guidance for authors ICMJE (1979) BMJ (1983) BJOG (1989) CMAJ (1990)
focused on format rather than scientific details
BMJ (1983)
did not differentiate between conduct and report
BJOG (1989)
Reporting of trials, screening and diagnostic tests, observational studies
CMAJ (1990)
series of recommendations for different types of study designs
Prior to the mid 1990s
few efforts specifically devoted to developing reporting guidelines for health research studies
Journals have not stood by ideally – mention ICMJE guidance (Schriger evidence)

8. Reporting guidelines Checklist Flow diagram
Explicit text to guide authors in reporting a specific type of research, developed using explicit methodology
A consensus process, which involves obtaining agreement among stakeholders (e.g., journal editors, methodologists and content experts) should be a crucial characteristic
Carefully developed reporting guidelines provide authors with a minimum set of items that need to be addressed when reporting a study
Another tool in the box – reporting guidelines
Moher D, et al. PLoS Med 2010;7(2): e

9. CONSORT 2010
Reporting guidelines provide guidance on what to include in research report
Benefits of using reporting guidelines:
Improved accuracy and transparency of publications
Easier appraisal of reports for research quality and relevance
Better further use of presented findings
Improved efficiency of literature searching
Example: CONSORT Statement for reporting randomised trials
(25-item checklist and flow diagram)
Schulz KF, et al. BMJ 2010;340:c332; Moher D, et al. BMJ 2010;340:c

11. Do reporting guidelines improve the quality of reporting of health research reports?
CONSORT endorsing journals versus non-endorsing journals
Sequence generation is approximately 56% better reported in the 673 trial reports in endorsing journals compared to the 1231 trials published in non-endorsing journals (RR = 1.56; 95%CI: 1.36, 1.80).  
Moher D, et al. Cochrane Database of Systematic Reviews 2010, Issue 3. Art. No.: MR000030

12. CONSORT endorsing journals versus non-endorsing journals
Checklist Item
Number
of Studies
Risk
Lower
Upper
Risk ratio and 95% CI
ratio
limit
limit
Title and Abstract 6
1.15
0.97
1.36
Introduction 5
1.06
1.01
1.11
Participants 5
1.17
0.91
1.50
Interventions 6
1.00
0.96
1.04
Objectives 4
1.00
0.96
1.04
Outcomes 7
1.26
0.99
1.60
Sample Size 10
1.64
1.19
2.26
Sequence Generation 13
1.60
1.42
1.81
Allocation Concealment 15
1.83
1.34
2.50
Implementation 5
2.90
0.74
11.40
Blinding 8
1.25
1.01
1.54
Statistical Methods 8
1.02
0.89
1.18
Participant Flow 15
1.24
1.01
1.53
Recruitment 6
0.94
0.79
1.14
Baseline Data 5
1.08
0.97
1.21
Numbers Analysed 11
1.24
1.01
1.53
Outcomes and Estimation 5
1.00
0.96
1.04
Ancillary Analysis 3
0.99
0.59
1.66
Adverse Events 8
1.17
0.91
1.50
Interpretation 3
1.00
0.96
1.04
Generalizability 3
1.08
0.83
1.41
Overall Evidence 2
0.93
0.78
1.11
0.5 1 2
Does Not Favour
CONSORT
Favours
CONSORT

13. Reporting guidelines evaluations
Systematic review
STARD
Smidt N, et al. Neurology 2006; 67: 792-7
STRICTA
Prady SL, et al. PLoS ONE 2008;3(2): e1577
QUOROM
Delaney A, et al. Critical Care 2005;9:R575-82
EQUATOR project - funded by CIHR
Moher et al; ongoing. Funded by Canadian Institutes of Health Research

14. The EQUATOR Network www.equator-network.org
An international initiative set up to improve reliability of health research publications
To support better publication of research:
Advances the work of CONSORT, PRISMA, and other guidelines groups – focus on:
Better implementation of reporting guideines
Development of robust reporting guidelines

15. EQUATOR developments Free online Library for Health Research Reporting
Spanish version of the EQUATOR website
(in collaboration with PAHO)
Organized numerous workshops, seminars, talks and Annual Lectures
Received ongoing funding support
Published a number of research papers and articles promoting rigorous research reporting
Published a regular online newsletter disseminating information about new reporting guidelines and the latest developments
Simera I, et al. BMC Medicine 2010;8:24

16. EQUATOR resources

17. EQUATOR resources Developing a comprehensive educational program
Webinar
Crystal clear reporting of systematic reviews and EQUATOR Network
Developing short courses
Editors and peer reviewers
Young research professionals and research students

18. EQUATOR resources

19. Moving forward - the challenges (1): Process
Work collaboratively
Avoid duplication of effort
Build efficiencies

20. Moving forward - the challenges (2): Science
EQUATOR-GRAD
Objective: To develop a reporting guideline assessment tool to aid in optimal guideline development
Intended Impact: Help editors and funders decide which reporting guidelines to implement
Implementing reporting guidelines in journals
What are the barriers and facilitators
Developing effective knowledge translation (KT) strategies
Behaviour change techniques
Evaluate KT strategies
Using experimental designs
Barriers – CONSORT is not effect; Turner et al systematic review results. CONSORT is difficult to implement – no evidence of this. Implementing CONSORT will reduce the number of submissions of RCTs – again no evidence of this
Theoretical Domains Framework
Michie S, et al. Quality and Safety in Health Care 2005;14(1):26

21. David Moher: dmoher@ohri.ca EQUATOR NETWORK www.equator-network.org
Thank you!
David Moher:
EQUATOR NETWORK

22. Fidelity of intervention
Are authors, peer reviewers, and editors using CONSORT?
Endorsement concerns:
2003, 22% (36/166) high impact factor journals provided any mention of CONSORT
2008, 38% (62/165) of high impact factor journals
73% relative improvement
Same (121) journals in both years
26% in 2003 and 39% in 2008
Altman DG. BMJ 2005:330: ; Hopewell et al. Trials 2008,9:20