Dataset Information

Recruiting participants with peripheral arterial disease for clinical trials: experience from the Study to Improve Leg Circulation (SILC).

ABSTRACT:

Objective

To describe the success of diverse recruitment methods in a randomized controlled clinical trial of exercise in persons with peripheral arterial disease (PAD).

Methods

An analysis of recruitment sources conducted for the 746 men and women completing a baseline visit for the study to improve leg circulation (SILC), a randomized controlled trial of exercise for patients with PAD. For each recruitment source, we determined the number of randomized participants, the rate of randomization among those completing a baseline visit, and cost per randomized participant.

Results

Of the 746 individuals who completed a baseline visit, 156 were eligible and randomized. The most frequent sources of randomized participants were newspaper advertising (n = 67), mailed recruitment letters to patients with PAD identified at the study medical center (n = 25), and radio advertising (n = 18). Costs per randomized participant were $2750 for television advertising, $2167 for Life Line Screening, $2369 for newspaper advertising, $3931 for mailed postcards to older community dwelling men and women, and $5691 for radio advertising. Among those completing a baseline visit, randomization rates ranged from 10% for those identified from radio advertising to 32% for those identified from the Chicago Veterans Administration and 33% for those identified from posted flyers.

Conclusion

Most participants in a randomized controlled trial of exercise were recruited from newspaper advertising and mailed recruitment letters to patients with known PAD. The highest randomization rates after a baseline visit occurred among participants identified from posted flyers and mailed recruitment letters to PAD patients.

SUBMITTER: McDermott MM

PROVIDER: S-EPMC9440619 | biostudies-literature | 2009 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Recruiting participants with peripheral arterial disease for clinical trials: experience from the Study to Improve Leg Circulation (SILC).

McDermott Mary M MM Domanchuk Kathryn K Dyer Alan A Ades Philip P Kibbe Melina M Criqui Michael H MH

Journal of vascular surgery 20090109 3

<h4>Objective</h4>To describe the success of diverse recruitment methods in a randomized controlled clinical trial of exercise in persons with peripheral arterial disease (PAD).<h4>Methods</h4>An analysis of recruitment sources conducted for the 746 men and women completing a baseline visit for the study to improve leg circulation (SILC), a randomized controlled trial of exercise for patients with PAD. For each recruitment source, we determined the number of randomized participants, the rate of ...[more]

PMID: 19135834

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Project description:BackgroundHypertension is a major risk factor for peripheral artery disease (PAD). Little is known about relative efficacy of antihypertensive treatments for preventing PAD.ObjectivesTo compare, by randomized treatment groups, hospitalized or revascularized PAD rates and subsequent morbidity and mortality among participants in the Antihypertensive and Lipid-Lower Treatment to Prevent Heart Attack Trial (ALLHAT).DesignRandomized, double-blind, active-control trial in high-risk hypertensive participants.ParticipantsEight hundred thirty participants with specified secondary outcome of lower extremity PAD events during the randomized phase of ALLHAT.Interventions/eventsIn-trial PAD events were reported during ALLHAT (1994-2002). Post-trial mortality data through 2006 were obtained from administrative databases. Mean follow-up was 8.8 years.Main measuresBaseline characteristics and intermediate outcomes in three treatment groups, using the Kaplan-Meier method to calculate cumulative event rates and post-PAD mortality rates, Cox proportional hazards regression model for hazard ratios and 95 % confidence intervals, and multivariate Cox regression models to examine risk differences among treatment groups.Key resultsFollowing adjustment for baseline characteristics, neither participants assigned to the calcium-channel antagonist amlodipine nor to the ACE-inhibitor lisinopril showed a difference in risk of clinically advanced PAD compared with those in the chlorthalidone arm (HR, 0.86; 95 % CI, 0.72-1.03 and HR, 0.98; 95 % CI, 0.83-1.17, respectively). Of the 830 participants with in-trial PAD events, 63 % died compared to 34 % of those without PAD; there were no significant treatment group differences for subsequent nonfatal myocardial infarction, coronary revascularizations, strokes, heart failure, or mortality.ConclusionsNeither amlodipine nor lisinopril showed superiority over chlorthalidone in reducing clinically advanced PAD risk. These findings reinforce the compelling need for comparative outcome trials examining treatment of PAD in high-risk hypertensive patients. Once PAD develops, cardiovascular event and mortality risk is high, regardless of type of antihypertensive treatment.

Project description: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.

Project description:ObjectivesTo assess feasibility and effect of multimodal prehabilitation in patients with severe life-limiting intermittent claudication and complex infrainguinal disease.DesignCase series of patients who underwent a 12-week prehabilitation program.SettingOutpatient clinic of a public tertiary hospital.ParticipantsPatients with a diagnosis of severe life-limiting intermittent claudication (Fontaine stage IIb and III) with complex infrainguinal disease or previous failed bypass attempts (N=5) who were referred to the prehabilitation clinic by a vascular surgeon.InterventionsPatients underwent a baseline assessment that included quality of life questionnaires and functional capacity tests. After baseline assessment, they received a 12-week prehabilitation program that consisted of (1) a supervised exercise session 1 time per week; (2) home-based exercise prescription; (3) nutritional counseling; (4) smoking cessation; and (5) psychosocial intervention. Adherence to all components was recorded as well as the occurrence of any adverse event. After completion of the 12-week program, patients were reassessed.Main outcome measureFeasibility of prehabilitation measured by adherence to the different components of the program and occurrence of adverse events.ResultsAll 5 patients completed the program. No serious adverse events occurred during the length of prehabiliation. Median adherence to each prehabilitation component was 91.7% (interquartile range [IQR], 33.5%) for supervised training, 91.7% (IQR, 40%) for home-based exercise, and 75% (IQR, 50%) for nutrition. Three of the 5 patients underwent psychosocial intervention and all who were active smokers enrolled in the smoking cessation program. Functional capacity measured with the 6-minute walk distance improved by 70 m (IQR, 99 m), and disease-specific quality of life measured with the Vascular Quality of Life Questionnaire improved by 25%.ConclusionMultimodal prehabilitation appears to be a feasible tool that could be used to increase functional capacity and quality of life for patients with complex infrainguinal disease and expected poor revascularization outcome or previous failed bypass attempts.

Dataset Information

Recruiting participants with peripheral arterial disease for clinical trials: experience from the Study to Improve Leg Circulation (SILC).

Objective

Methods

Results

Conclusion

Publications

Recruiting participants with peripheral arterial disease for clinical trials: experience from the Study to Improve Leg Circulation (SILC).

Similar Datasets

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