Contemporary clinical trials
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Contemp Clin Trials · Jul 2011
Randomized Controlled TrialDesign and implementation of the Exercise for Health trial -- a pragmatic exercise intervention for women with breast cancer.
Exercise for Health was a pragmatic, randomised, controlled trial comparing the effect of an eight-month exercise intervention on function, treatment-related side effects and quality of life following breast cancer, compared with usual care. The intervention commenced six weeks post-surgery, and two modes of delivering the same intervention was compared with usual care. The purpose of this paper is to describe the study design, along with outcomes related to recruitment, retention and representativeness, and intervention participation. ⋯ Participation in both intervention arms during and following treatment for breast cancer was feasible and acceptable to women. Future work, designed to inform translation into practice, will evaluate the quality of life, clinical, psychosocial and behavioural outcomes associated with each mode of delivery.
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Contemp Clin Trials · May 2011
ReviewMore than the money: a review of the literature examining healthy volunteer motivations.
Few existing data report the motivations of healthy volunteers in clinical research trials. Some worry that volunteers consider only financial motivations. This study summarized and analyzed existing empirical research on self-reported motivations of healthy volunteers participating in studies not intended to offer benefit from participation. ⋯ Although financial incentives are important in recruiting healthy volunteers, their motivations are not limited to financial motivations. Further research is needed to examine motivations in different contexts and countries, the decision making of healthy volunteers, and the dynamics of repeat participation.
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Contemp Clin Trials · May 2011
Clinical validation study to measure the performance of the Nerve Root Sedimentation Sign for the diagnosis of lumbar spinal stenosis.
Lumbar spinal stenosis is a common degenerative disorder of the spine in elderly patients that can be effectively treated with decompression surgery in some patients. Radiological findings in the diagnostic work-up of the patients do not always correlate well with clinical symptoms, and guidance about when to proceed to surgery is inconsistent. The recently described Nerve Root Sedimentation Sign in magnetic resonance scans has been shown to discriminate well between selected patients with and without lumbar spinal stenosis, but the performance of this new test, when used in a broad patient population, is not yet known. ⋯ The results will be used to estimate: i) how well the Sedimentation Sign can distinguish between patients that do or do not benefit from surgery, and ii) the concordance between the Sedimentation Sign and existing tests to explore its possible value as a triage test. This study design will provide data to estimate the potential benefits and harms of using the Sedimentation Sign to guide surgical decisions. The observed proportion of discordant test results will help inform the design of future randomised controlled trials of the Sedimentation Sign.
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Contemp Clin Trials · May 2011
Randomized Controlled TrialThibela TB: design and methods of a cluster randomised trial of the effect of community-wide isoniazid preventive therapy on tuberculosis amongst gold miners in South Africa.
South Africa has the third highest annual number of new tuberculosis (TB) cases globally. The resurgence of TB which has particularly affected gold miners in South Africa, is attributed to occupational risk factors for TB including silica dust exposure and high HIV prevalence. Isoniazid preventive therapy (IPT) is recommended for individuals at high risk to prevent both HIV-related TB and silicotuberculosis, but global uptake has been poor. We describe the design of a cluster randomised study, "Thibela TB", which compares routine IPT targeted to those identified as at higher risk of TB (due to HIV infection or silicosis) against a "community-wide" approach in which IPT is offered to all employees. The trial is registered with the Current Controlled Trials: Registration number ISRCTN63327174. ⋯ If successful in reducing TB incidence and prevalence, this trial has potential to make a major contribution to TB control policy in high HIV settings, providing evidence concerning efficacy, and additionally safety and population-level effects on drug susceptibility patterns. Such rigorous evaluation is essential to provide policy makers with an evidence base to guide community-level TB prevention strategies.
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Contemp Clin Trials · May 2011
Comparative StudyAnalysis of tumor burden versus progression-free survival for Phase II decision making.
There have been recent recommendations to use percentage change in tumor burden (dTB) as a primary endpoint in randomized Phase II trials. We assessed whether dTB is better for the decision to start a Phase III trial than is progression-free survival (PFS). ⋯ Analysis of PFS in randomized Phase II trials generally leads to better 'Phase III go' decisions than does analysis of dTB. Tumor burden analyses should be used in supportive analyses to a primary PFS analysis.