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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.

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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