File
Slade S.1, Dionne C.2, Underwood M.3, Buchbinder R.1
1Monash University, Clinical Epidemiology, Melbourne, Australia, 2Laval University, Rehabilitation, Quebec, Canada, 3University of Warwick, Clinical Trials Unit, Coventry, United Kingdom
Background: Exercise is effective for prevention and management of acute and chronic health conditions. Various types of exercise, including aerobic, resistance or balance training, yoga, Pilates, flexibility and movement retraining programs are examples of complex interventions reported to be effective yet have been poorly described in clinical trial reports, leaving readers unclear about the content of effective programs. To address this, the 16-item internationally endorsed Consensus on Exercise Reporting Template (CERT) was developed.
Purpose: To develop a standardized method for reporting exercise programs in clinical trials, the CERT; and to provide an Explanation and Elaboration Statement for implementation guidance.
Methods: Development of the CERT was based upon the EQUATOR Network methodological framework for developing reporting guidelines. We invited 137 exercise experts to participate in a Delphi consensus study and rate a list of 41 items identified from a systematic review of exercise. For each item, participants indicated agreement on an 11-point rating scale. Consensus for item inclusion was defined a priori as greater than 70% agreement of respondents rating an item seven or above. We used three sequential rounds of anonymous online questionnaires and a Delphi workshop; finalized the reporting guideline; and developed an Explanation and Elaboration Statement.
Results: There were 57, 54 and 49 respondents to Rounds 1-3 respectively from 11 countries and a range of disciplines. In Round One, two items were excluded; 24 items reached consensus for inclusion (eight items in original format); and 16 items revised in response to participant suggestions. Of 14 items in Round Two, three were excluded; 11 reached consensus for inclusion (four items accepted in original format); and seven reworded. Sixteen items were included in Round Three and all items reached greater than 70% consensus for inclusion. The 16-item CERT provides guidance on a minimum set of key items considered essential to report replicable exercise programs, recognising that additional information may be needed for individual studies, depending upon the exercise program under study. The contents may be included in online supplementary material, published as a protocol or located on websites and other electronic repositories. The Explanation and Elaboration Statement is designed to enhance the use, understanding and dissemination of the CERT and presents the meaning and rationale for each item, together with examples of good reporting.
Conclusion(s): The CERT is an internationally endorsed guideline designed specifically for the reporting of exercise programs across all evaluative study designs for exercise research. It contains seven categories: materials, provider, delivery, location, dosage, tailoring, and compliance. It is intended to be used as an extension of Item 5 of the CONSORT Statement and Item 11 of the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT) Statement.
Implications: The CERT can be used by authors to structure intervention reports, by reviewers and editors to assess completeness of exercise descriptions, and by readers to facilitate use of the published information. The CERT will encourage transparency, improve trial interpretation and replication, facilitate implementation of effective exercise interventions into practice, reduce research waste, and improve patient outcomes.
Funding acknowledgements: Arthritis Australia Philip Benjamin Grant: 2014GIA03; J Mason and H S Williams Memorial Foundation (the Mason Foundation): MAS2015F037.
Topic: Research methodology & knowledge translation
Ethics approval: The Cabrini Institute Ethics Committee approved the project (HREC 02-07-04-14)
All authors, affiliations and abstracts have been published as submitted.
