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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.

SUBMITTER: Tew GA

PROVIDER: S-EPMC4777572 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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The Completeness of Intervention Descriptions in Randomised Trials of Supervised Exercise Training in Peripheral Arterial Disease.

Tew Garry A GA Brabyn Sally S Cook Liz L Peckham Emily E

PloS one 20160303 3

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 prac ...[more]

PMID: 26938879

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Project description:OBJECTIVE:To evaluate the impact of an editorial intervention to improve completeness of reporting of reports of randomised trials. DESIGN:Randomised controlled trial (RCT). SETTING:BMJ Open's quality improvement programme. PARTICIPANTS:24 manuscripts describing RCTs. INTERVENTIONS:We used an R Shiny application to randomise manuscripts (1:1 allocation ratio, blocks of 4) to the intervention (n=12) or control (n=12) group. The intervention was performed by a researcher with expertise in the content of the Consolidated Standards of Reporting Trials (CONSORT) and consisted of an evaluation of completeness of reporting of eight core CONSORT items using the submitted checklist to locate information, and the production of a report containing specific requests for authors based on the reporting issues found, provided alongside the peer review reports. The control group underwent the usual peer review. OUTCOMES:The primary outcome is the number of adequately reported items (0-8 scale) in the revised manuscript after the first round of peer review. The main analysis was intention-to-treat (n=24), and we imputed the scores of lost to follow-up manuscripts (rejected after peer review and not resubmitted). The secondary outcome is the proportion of manuscripts where each item was adequately reported. Two blinded reviewers assessed the outcomes independently and in duplicate and solved disagreements by consensus. We also recorded the amount of time to perform the intervention. RESULTS:Manuscripts in the intervention group (mean: 7.01; SD: 1.47) were more completely reported than those in the control group (mean: 5.68; SD: 1.43) (mean difference 1.43, 95% CI 0.31 to 2.58). We observed the main differences in items 6a (outcomes), 9 (allocation concealment mechanism), 11a (blinding) and 17a (outcomes and estimation). The mean time to perform the intervention was 87 (SD 42) min. CONCLUSIONS:We demonstrated the benefit of involving a reporting guideline expert in the editorial process. Improving the completeness of RCTs is essential to enhance their usability. TRIAL REGISTRATION NUMBER:NCT03751878.

Project description:BackgroundMobile health interventions are intended to support complex health care needs in chronic diseases digitally, but they are mainly targeted at general health improvement and neglect disease-specific requirements. Therefore, we designed TrackPAD, a smartphone app to support supervised exercise training in patients with peripheral arterial disease.ObjectiveThis pilot study aimed to evaluate changes in the 6-minute walking distance (meters) as a primary outcome measure. The secondary outcome measures included changes in physical activity and assessing the patients' peripheral arterial disease-related quality of life.MethodsThis was a pilot two-arm, single-blinded, randomized controlled trial. Patients with symptomatic PAD (Fontaine stage IIa/b) and access to smartphones were eligible. Eligible participants were randomly assigned to the study, with the control group stratified by the distance covered in the 6-minute walking test using the TENALEA software. Participants randomized to the intervention group received usual care and the mobile intervention (TrackPAD) for the follow-up period of 3 months, whereas participants randomized to the control group received routine care only. TrackPAD records the frequency and duration of training sessions and pain levels using manual user input. Clinical outcome data were collected at the baseline and after 3 months via validated tools (the 6-minute walk test and self-reported quality of life). The usability and quality of the app were determined using the Mobile Application Rating Scale user version.ResultsThe intervention group (n=19) increased their mean 6-minute walking distance (83 meters, SD 72.2), while the control group (n=20) decreased their mean distance after 3 months of follow-up (-38.8 meters, SD 53.7; P=.01). The peripheral arterial disease-related quality of life increased significantly in terms of "symptom perception" and "limitations in physical functioning." Users' feedback showed increased motivation and a changed attitude toward performing supervised exercise training.ConclusionsBesides the rating providing a valuable support tool for the user group, the mobile intervention TrackPAD was linked to a change in prognosis-relevant outcome measures combined with enhanced coping with the disease. The influence of mobile interventions on long-term prognosis must be evaluated in the future.Trial registrationClinicalTrials.gov NCT04947228; https://clinicaltrials.gov/ct2/show/NCT04947228.

Project description:BACKGROUND:Exercise is an effective therapeutic intervention for cancer survivors. Concerns about the completeness of reporting of exercise interventions have been raised in the literature, but without any formal analysis. This study aimed to evaluate the completeness of reporting of exercise interventions for cancer survivors in a large sample of randomized clinical trials (RCTs). METHODS:We developed a pre-defined protocol. We searched MEDLINE, EMBASE, and CENTRAL for exercise trials in oncology between 2010 and 2017. Pairs of independent researchers screened the records, extracted study characteristics, and assessed 16 items on the TIDieR checklist (i.e., the 12 items, with item 5 divided into two and item 8 divided into four). For each of these items, the percentage of interventions in the included studies that reported the item was calculated. RESULTS:We included 131 RCTs reporting 138 interventions in the analysis. Breast cancer was the most common type of cancer (69, 50%), and aerobic exercise was the most studied exercise modality (43, 30%) followed by combined aerobic and resistance training (40, 28%). Completeness of reporting ranged from 42 to 96% among the TIDieR items; none of the items was fully reported. 'Intervention length' was the most reported item across interventions (133, 96%), followed by 'rationale' (131, 95%), whereas 'provider' (58, 42%) and 'how well (planned)' (63, 46%) were the two least reported items. Half of the TIDieR items were completely reported in 50 to 70% of the interventions, and only four items were reported in more than 80% of the interventions (Items 2 and 8a to c). The seven items deemed to be core for replication (Items 3 to 9) exhibited a mean reporting of 71%, ranging from 42 to 96%. CONCLUSION:Exercise training interventions for cancer survivors are incompletely reported across RCTs published between 2010 and 2017. The reporting of information about the provider, materials, and modifications require urgent improvements. Stronger reporting will enhance usability of trial reports by both healthcare providers and survivors, and will help to reduce research waste.

Project description:Venous leg ulcers are common, chronic wounds that are painful and reduce quality of life. Compression therapy is known to assist in the healing of venous leg ulceration. Supervised exercise training that targets an improvement in calf muscle pump function might be a useful adjunctive therapy for enhancing ulcer healing and other aspects of physical and mental health. However, the evidence of exercise for individuals with venous ulcers is sparse. Here, we describe the protocol for a study that aims to assess the feasibility of undertaking a randomised controlled trial of a supervised exercise programme in people who are receiving compression for venous ulceration.This is a randomised, controlled, assessor-blinded, two-centre, feasibility trial with two parallel groups. Eighty adults who are receiving lower-limb compression for a venous leg ulcer will be randomly assigned to receive usual care (compression only) or usual care plus a 12-week supervised exercise programme. Participants in the exercise group will be invited to undertake three, 60-minute sessions of supervised exercise each week, and each session will involve a combination of treadmill walking, upright cycling and strength and flexibility exercises for the lower limbs. Participants will be assessed before randomisation and 3, 6 and 12 months after randomisation. Primary outcomes include rates of recruitment, retention and adherence. Secondary outcomes include time to ulcer healing, proportion of participants healed, percentage and absolute change in ulcer size, health-related quality of life (EQ-5D-5L and VEINES-QOL/Sym), lower-limb cutaneous microvascular function (laser Doppler flowmetry coupled with iontophoresis) and physical fitness (30-second sit-to-stand test, chair sit and reach test, 6-minute walk test and ankle range of motion). The costs associated with the exercise programme and health-care utilisation will be calculated. We will also complete interviews with a sub-sample of participants to explore their experiences of having a venous ulcer and the acceptability of the exercise intervention and study procedures.Data from this study will be used to refine the supervised exercise programme, investigate the acceptability of the intervention and study design and determine the most appropriate outcome measures, thereby providing estimates of the factors needed to design an adequately powered trial across several centres.Current Controlled Trials, ISRCTN10205425 (May 2014) - http://www.controlled-trials.com/ISRCTN10205425.

Project description:BACKGROUND:Peripheral arterial disease (PAD) is a common and severe disease with a highly increased cardiovascular morbidity and mortality. Through the circulatory disorder and the linked undersupply of oxygen carriers in the lower limbs, the ongoing decrease of the pain-free walking distance occurs with a significant reduction in patients' quality of life. Studies including activity monitoring for patients with PAD are rare and digital support to increase activity via mobile health technologies is mainly targeted at patients with cardiovascular disease in general. The special requirement of patients with PAD is the need to reach a certain pain level to improve the pain-free walking distance. Unfortunately, both poor adherence and availability of institutional resources are major problems in patient-centered care. OBJECTIVE:The objective of this trackPAD pilot study is to evaluate the feasibility of a mobile phone-based self tracking app to promote physical activity and supervised exercise therapy (SET) in particular. We also aim for a subsequent patient centered adjustment of the app prototype based on the results of the app evaluation and process evaluation. METHODS:This study was designed as a closed user group trial, with assessors blinded, and parallel group study with face-to-face components for assessment with a follow-up of 3 months. Patients with symptomatic PAD (Fontaine stage IIa or IIb) and possession of a mobile phone were eligible. Eligible participants were randomly assigned into study and control group, stratified by their distance covered in the 6-min walk test, using the software TENALEA. Participants randomized to the study group received usual care and the mobile intervention (trackPAD) for the follow-up period of 3 months, whereas participants randomized to the control group received only usual care. TrackPAD records the frequency and duration of training sessions and pain level using manual user input. Clinical outcome data were collected at the baseline and after 3 months via validated tools (6-min walk test, ankle-brachial index, and duplex ultrasound at the lower arteries) and self-reported quality of life. Usability and quality of the app was determined using the user version of the Mobile Application Rating Scale. RESULTS:The study enrolled 45 participants with symptomatic PAD (44% male). Of these participants, 21 (47%) were randomized to the study group and 24 (53%) were randomized to the control group. The distance walked in the 6-min walk test was comparable in both groups at baseline (study group: mean 368.1m [SD 77.6] vs control group: mean 394.6m [SD 100.6]). CONCLUSIONS:This is the first trial to test a mobile intervention called trackPAD that was designed especially for patients with PAD. Its results will provide important insights in terms of feasibility, effectiveness, and patient preferences of an app-based mobile intervention supporting SET for the conservative treatment of PAD. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/13651.

Dataset Information

The Completeness of Intervention Descriptions in Randomised Trials of Supervised Exercise Training in Peripheral Arterial Disease.

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The Completeness of Intervention Descriptions in Randomised Trials of Supervised Exercise Training in Peripheral Arterial Disease.

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