Reporting guidelines

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1 Reporting guidelines Diaa E.E. Rizk Editor, International Urogynecology Journal IUGA 2015 Nice Workshop #7 How to publish and review 9 June 2015 Aim of reporting guidelines Standardize reporting Allow complete and transparent reporting of research Enable readers to assess the internal validity and applicability of findings Facilitate comparison between published studies Improve quality of studies 1

How to access reporting guidelines Go to EQUATOR network homepage http://www.equator-network.

2 How to access reporting guidelines Go to EQUATOR network homepage EQUATOR Network Enhancing the QUAlity and Transparency Of health Research 2

EQUATOR Network Toolkits http://www.equator-network.org/ Elements of a reporting guideline 1.

3 EQUATOR Network Toolkits Elements of a reporting guideline 1. Publication where reporting guideline is described Is freely available (Open Access) Can be cited in manuscript 2. Checklist The tool of the reporting guideline Can be submitted with manuscript 3. Flowchart To be used in the manuscript 3

4 When to use reporting guidelines When writing a study protocol When writing a manuscript How to use reporting guidelines Identify type of study Choose the corresponding reporting guideline Go to the website of the reporting guideline Download checklist Apply checklist to study protocol Apply checklist to the manuscript Mention reporting guideline in the methods section 4

5 Characteristic of a reporting guideline Specific for study type RCT Observational study Systematic review / meta-analysis Case report Diagnostic study Qualitative Research And other studies Addresses all aspects of a study protocol / manuscript Title and abstract Introduction Methods Results Discussion Other information specific to type of study CONSORT Acronym CONsolidated Standards Of Reporting Trials Study type Randomized Controlled Trials Checklist Number of items 25 5

6 PRISMA Acronym Preferred Reporting Items of Systematic reviews and Meta-Analyses Study type Systematic reviews and meta-analyses Checklist Number of items 27 6

7 STROBE Acronym STrengthening the Reporting of OBservational studies in Epidemiology Study type Observational studies (cohort study, case-control study, cross-sectional study) Checklist Number of items 22 CARE Acronym CAse REporting Study type Case reports Checklist Number of items 13 (writing template available) 7

8 STARD Acronym STAndards for Reporting of Diagnostic Accuracy Study type Studies of diagnostic accuracy Checklist Number of items 25 SRQR Acronym Standards for Reporting of Qualitative Research Study type Qualitative research studies Checklist Number of items 21 8

More reporting guidelines on the EQUATOR homepage Currently 220 reporting guidelines Example: specialized CONSORT guidelines CONSORT Harms: Ioannidis JPA, Evans SJW, Gotzsche PC, O'Neill RT, Altman

9 More reporting guidelines on the EQUATOR homepage Currently 220 reporting guidelines Example: specialized CONSORT guidelines CONSORT Harms: Ioannidis JPA, Evans SJW, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D, for the CONSORT Group. Better reporting of harms in randomized trials: an extension of the CONSORT Statement. Ann Intern Med. 2004;141(10): PMID: CONSORT Non-inferiority: Piaggio G, Elbourne DR, Pocock SJ, Evans SJW, Altman DG, for the CONSORT Group. Reporting of noninferiority and equivalence randomized trials. Extension of the CONSORT 2010 statement. JAMA. 2012; 308(24): PMID: CONSORT Cluster: Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5661. PMID: CONSORT Herbal: Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C, for the CONSORT Group. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT Statement. Ann Intern Med. 2006;144(5): PMID: CONSORT Non-pharmacological treatment interventions: Boutron I, Moher D, Altman DG, Schulz K, Ravaud P, for the CONSORT group. Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments. Ann Intern Med. 2008:W60-W67. PMID:

10 Example: specialized CONSORT guidelines CONSORT Abstracts: Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF, the CONSORT Group. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008; 5(1):e20. PMID: CONSORT Pragmatic Trials: Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390. PMID: STRICTA Controlled trials of acupuncture: MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D; STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010;7(6):e PMID: CONSORT PRO: Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD; CONSORT PRO Group. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013;309(8): PMID: Literature Evidence Cochrane Database Syst Rev. 2012, Nov 14; 11. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Turner L, Shamseer L, Altman DG, et al. Update an earlier systematic review of whether journal endorsement of 1996 and 2001 CONSORT checklists influences completeness of reporting of RCTs published in medical journals. Review of comparative studies evaluating completeness of reporting of published RCTs in any of the following groups : 1) Journals that have and have not endorse the CONSORT statement 2) CONSORT endorsing journals before and after endorsement 3) Before and after the publication of the CONSORT statement (1996 or 2001). 10

11 Literature Evidence The definition of CONSORT endorsement was any of the following: (a) requirement or recommendation in journal s Instructions to Authors to follow CONSORT guidelines (b) journal editorial statement endorsing the CONSORT statement (c) editorial requirement for authors to submit a CONSORT checklist and/or flow diagram with their manuscript. The findings were similar to the original review: Despite the general inadequacies of reporting of RCTs, journal endorsement of the CONSORT statement may beneficially influence the completeness of reporting of trials published in medical journals. Literature Evidence BMJ, 2014 Jun 25. Relation of completeness of reporting of health research to journals endorsement of reporting guidelines: systematic review. Stevens A,Shamseer L,Weinstein E, et al. To investigate whether the completeness of reporting of health research is related to journals' endorsement of reporting guidelines (excluding the CONSORT statement) Assessment of the completeness of reporting of studies after versus before journal endorsement and/or endorsing versus non-endorsing journals. Insufficient evidence exists to determine the relation between journals endorsement of reporting guidelines and the completeness of reporting in published health research reports other than the CONSORT statement. 11

12 Future of reporting guidelines More reporting guidelines Specific reporting guidelines for subspecialties Specific reporting guidelines for study question BUT Too many reporting guidelines? Future Research Studies compared complete reporting before and after the publication of a reporting guideline but endorsement would serve as a stronger intervention given the need for manuscripts to adhere to a journal s Instruction to authors. Randomizing journals to endorse a reporting guideline or continue with usual editorial policy would be difficult. An alternative would be the use of reporting guidelines in the peer review process. A study found that within a single journal that did not endorse any reporting guidelines; manuscripts reviewed using reporting guidelines were of better quality than those that did not use reporting guidelines. 12

13 Conclusions Use reporting guidelines Complete manuscript Better manuscript Study replicable Study comparable Study can be used in systematic reviews / meta-analyses Mention reporting guidelines in your manuscript Editors and reviewers will take note 13

From protocol to publication: ensuring quality in the reporting of continence research Workshop 20 Monday, August 23rd 2010, 14:00 17:00

From protocol to publication: ensuring quality in the reporting of continence research Workshop 20 Monday, August 23rd 2010, 14:00 17:00 Time Time Topic Speaker 14:00 14:15 Introduction Rufus Cartwright