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Reporting guidelines: current status

Reporting guidelines: current status. Outline. A very brief look at reporting of health research Reporting guidelines EQUATOR Network Challenges – the road ahead. Quality of reports of randomized trials.

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Reporting guidelines: current status

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  1. 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 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 Chalmers and Glasziou Lancet 2009;374:86-89; Dancey JNCI 2010; 102:670-671

  7. Guidance for authors • ICMJE (1979) • 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

  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 Moher D, et al. PLoS Med 2010;7(2): e1000217

  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:c869. www.consort-statement.org

  10. Do reporting guidelines improve the quality of reporting of health research reports? 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

  11. CONSORT endorsing journals versus non-endorsing journals Risk CONSORT Checklist Item Number of Studies Risk ratio and 95% CI Lower Upper 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

  12. 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 Moher et al; ongoing. Funded by Canadian Institutes of Health Research

  13. The EQUATOR Networkwww.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

  14. 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

  15. EQUATOR resources

  16. EQUATOR resources • Developing a comprehensive educational program • Webinar • Crystal clear reporting of systematic reviews and EQUATOR Network • http://www.youtube.com/watch?v=TVFYenon1Jo&feature=player_embedded • Developing short courses • Editors and peer reviewers • Young research professionals and research students

  17. EQUATOR resources

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

  19. 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 Michie S, et al. Quality and Safety in Health Care 2005;14(1):26

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

  21. 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 2005:330:1056-1057; Hopewell et al. Trials 2008,9:20

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