Post on 13-Oct-2018
7/4/2016
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Reporting guidelines
Maria BortoliniEditor International Urogynecology Journal
maria.bortolini@gmail.com
IUGA 2016 Cape Town | South AfricaWorkshop #10 | Reviewing a manuscript| 4 Aug 2016
maria.augusta@gmail.com
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
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How to access reporting guidelines
Go toEQUATORnetwork homepage
http://www.equator-network.org
EQUATOR NetworkEnhancing the QUAlity and TransparencyOf health Research
http://www.equator-network.org/
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EQUATOR NetworkToolkits
http://www.equator-network.org/
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
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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
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Characteristic of a reporting guidelineSpecific 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
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PRISMA
Acronym
Preferred Reporting Items of Systematic reviews andMeta-Analyses
Study type
Systematic reviews and meta-analyses
Checklist
Number of items 27
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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)
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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
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More reporting guidelines on the EQUATOR homepage
Currently 220 reporting guidelines
Example: specialized CONSORT guidelinesCONSORT 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):781-788. PMID: 15545678
CONSORT Non-inferiority: Piaggio G, Elbourne DR, Pocock SJ, Evans SJW, Altman DG, for the CONSORT Group. Reporting of noninferiority and equivalencerandomized trials. Extension of the CONSORT 2010 statement. JAMA. 2012; 308(24): 2594-2604. PMID: 23268518
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: 22951546
CONSORT Herbal: Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C, for the CONSORT Group. Reporting randomized, controlled trials of herbalinterventions: an elaborated CONSORT Statement. Ann Intern Med. 2006;144(5):364-367. PMID: 16520478
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 non-pharmacologic treatments. Ann Intern Med. 2008:W60-W67. PMID: 18283201
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Example: specialized CONSORT guidelinesCONSORT Abstracts: Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF, the CONSORT Group. CONSORT for reporting randomizedcontrolled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008; 5(1):e20. PMID: 18215107
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: 19001484
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 ofAcupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010;7(6):e1000261. PMID: 20543992
CONSORT PRO: Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD; CONSORT PRO Group. Reporting of patient-reported outcomes in randomizedtrials: the CONSORT PRO extension. JAMA. 2013;309(8):814-22. PMID: 23443445
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).
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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.
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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.