title: The Completeness of Intervention Descriptions in Randomised Trials of Supervised Exercise Training in Peripheral Arterial Disease.
abstract: Research supports the use of supervised exercise training as a primary therapy for improving the functional status of people with peripheral arterial disease (PAD). Several reviews have focused on reporting the outcomes of exercise interventions, but none have critically examined the quality of intervention reporting. Adequate reporting of the exercise protocols used in randomised controlled trials (RCTs) is central to interpreting study findings and translating effective interventions into practice. The purpose of this review was to evaluate the completeness of intervention descriptions in RCTs of supervised exercise training in people with PAD. A systematic search strategy was used to identify relevant trials published until June 2015. Intervention description completeness in the main trial publication was assessed using the Template for Intervention Description and Replication checklist. Missing intervention details were then sought from additional published material and by emailing authors. Fifty-eight trials were included, reporting on 76 interventions. Within publications, none of the interventions were sufficiently described for all of the items required for replication; this increased to 24 (32%) after contacting authors. Although programme duration, and session frequency and duration were well-reported in publications, complete descriptions of the equipment used, intervention provider, and number of participants per session were missing for three quarters or more of interventions (missing for 75%, 93% and 80% of interventions, respectively). Furthermore, 20%, 24% and 26% of interventions were not sufficiently described for the mode of exercise, intensity of exercise, and tailoring/progression, respectively. Information on intervention adherence/fidelity was also frequently missing: attendance rates were adequately described for 29 (38%) interventions, whereas sufficient detail about the intensity of exercise performed was presented for only 8 (11%) interventions. Important intervention details are commonly missing for supervised exercise programmes in the PAD trial literature. This has implications for the interpretation of outcome data, the investigation of dose-response effects, and the replication of protocols in future studies and clinical practice. Researchers should be mindful of intervention reporting guidelines when attempting to publish information about supervised exercise programmes, regardless of the population being studied.
authors.affiliation: Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle Upon Tyne, United Kingdom.
authors.forename: Garry A
authors.initials: GA
authors.lastname: Tew
authors.affiliation: Mental Health and Addiction Group, Department of Health Sciences, University of York, York, United Kingdom.
authors.forename: Sally
authors.initials: S
authors.lastname: Brabyn
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
authors.forename: Liz
authors.initials: L
authors.lastname: Cook
authors.affiliation: Mental Health and Addiction Group, Department of Health Sciences, University of York, York, United Kingdom.
authors.forename: Emily
authors.initials: E
authors.lastname: Peckham
mesh_terms: D000368:Aged; D002309:Cardiology / Q000379:methods; D018450:Disease Progression; D015444:Exercise; D005081:Exercise Therapy / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000628:therapy*; D015995:Prevalence; D016032:Randomized Controlled Trials as Topic; D012107:Research Design