A Guide to the Reporting of Protocols of Pilot and Feasibility Trials

Overview

Journal Pilot Feasibility Stud

Publisher Biomed Central

Date 2019 Mar 13

PMID 30858987

Citations 83

Authors

Lehana Thabane

Gillian Lancaster

Affiliations

Soon will be listed here.

Abstract

Publishing protocols of trials including protocols of pilot and feasibility trials-designed to inform the designs of main trials-has been advocated as an important strategy towards improving transparency in the conduct and reporting of main trials and pilot/feasibility trials. This editorial aims to provide some general guidance on how to report protocols of pilot and feasibility trials, drawing upon two available resources-the CONSORT extension to pilot trials and the SPIRIT guideline for main trials. We describe how these might be adapted for the reporting of protocol manuscripts of pilot and feasibility trials for submission in journal.

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References

Ioannidis J, Evans S, Gotzsche P, ONeill R, Altman D, Schulz K . Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004; 141(10):781-8. DOI: 10.7326/0003-4819-141-10-200411160-00009. View

Gagnier J, Boon H, Rochon P, Moher D, Barnes J, Bombardier C . Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med. 2006; 144(5):364-7. DOI: 10.7326/0003-4819-144-5-200603070-00013. View

Boutron I, Moher D, Altman D, Schulz K, Ravaud P . Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments. Ann Intern Med. 2008; 148(4):W60-6. DOI: 10.7326/0003-4819-148-4-200802190-00008-w1. View

Zwarenstein M, Treweek S, Gagnier J, Altman D, Tunis S, Haynes B . Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008; 337:a2390. PMC: 3266844. DOI: 10.1136/bmj.a2390. View

Schulz K, Altman D, Moher D . CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010; 340:c332. PMC: 2844940. DOI: 10.1136/bmj.c332. View

MacPherson H, Altman D, Hammerschlag R, Youping L, Taixiang W, White A . Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010; 7(6):e1000261. PMC: 2882429. DOI: 10.1371/journal.pmed.1000261. View

Campbell M, Piaggio G, Elbourne D, Altman D . Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012; 345:e5661. DOI: 10.1136/bmj.e5661. View

Piaggio G, Elbourne D, Pocock S, Evans S, Altman D . Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012; 308(24):2594-604. DOI: 10.1001/jama.2012.87802. View

Chan A, Tetzlaff J, Altman D, Laupacis A, Gotzsche P, Krleza-Jeric K . SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013; 158(3):200-7. PMC: 5114123. DOI: 10.7326/0003-4819-158-3-201302050-00583. View

10.

Chan A, Tetzlaff J, Gotzsche P, Altman D, Mann H, Berlin J . SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013; 346:e7586. PMC: 3541470. DOI: 10.1136/bmj.e7586. View

11.

Calvert M, Blazeby J, Altman D, Revicki D, Moher D, Brundage M . Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013; 309(8):814-22. DOI: 10.1001/jama.2013.879. View

12.

Chan A, Song F, Vickers A, Jefferson T, Dickersin K, Gotzsche P . Increasing value and reducing waste: addressing inaccessible research. Lancet. 2014; 383(9913):257-66. PMC: 4533904. DOI: 10.1016/S0140-6736(13)62296-5. View

13.

Vohra S, Shamseer L, Sampson M, Bukutu C, Schmid C, Tate R . CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. BMJ. 2015; 350:h1738. DOI: 10.1136/bmj.h1738. View

14.

Eldridge S, Chan C, Campbell M, Bond C, Hopewell S, Thabane L . CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016; 355:i5239. PMC: 5076380. DOI: 10.1136/bmj.i5239. View

15.

Thabane L, Hopewell S, Lancaster G, Bond C, Coleman C, Campbell M . Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials. Pilot Feasibility Stud. 2016; 2:25. PMC: 5153862. DOI: 10.1186/s40814-016-0065-z. View

16.

Eldridge S, Chan C, Campbell M, Bond C, Hopewell S, Thabane L . CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016; 2:64. PMC: 5154046. DOI: 10.1186/s40814-016-0105-8. View

17.

Li G, Abbade L, Nwosu I, Jin Y, Leenus A, Maaz M . A systematic review of comparisons between protocols or registrations and full reports in primary biomedical research. BMC Med Res Methodol. 2018; 18(1):9. PMC: 5765717. DOI: 10.1186/s12874-017-0465-7. View

18.

Chan A, Hrobjartsson A . Promoting public access to clinical trial protocols: challenges and recommendations. Trials. 2018; 19(1):116. PMC: 5816550. DOI: 10.1186/s13063-018-2510-1. View

19.

Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I . Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996; 276(8):637-9. DOI: 10.1001/jama.276.8.637. View