Contemporary clinical trials
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Contemp Clin Trials · Feb 2006
Randomized Controlled Trial Comparative StudyA pragmatic 2 x 2 x 2 factorial cluster randomized controlled trial of educational outreach visiting and case conferencing in palliative care-methodology of the Palliative Care Trial [ISRCTN 81117481].
The demand for palliative care is increasing, yet there are few data on the best models of care nor well-validated interventions that translate current evidence into clinical practice. Supporting multidisciplinary patient-centered palliative care while successfully conducting a large clinical trial is a challenge. The Palliative Care Trial (PCT) is a pragmatic 2 x 2 x 2 factorial cluster randomized controlled trial that tests the ability of educational outreach visiting and case conferencing to improve patient-based outcomes such as performance status and pain intensity. ⋯ The interventions are aimed at translating current evidence into clinical practice and there was particular attention in the trial's design to addressing common pitfalls for clinical studies in palliative care. Given the need for evidence about optimal interventions and service delivery models that improve the care of people with life-limiting illness, the results of this rigorous, high quality clinical trial will inform practice. Initial results are expected in mid 2005.
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Contemp Clin Trials · Oct 2005
Recruitment index as a measure of patient recruitment activity in clinical trials.
Recruitment of patients for clinical trials is one of the major hurdles on the way to successful completion of any human research study. Direct comparison of recruitment activity in different sites and projects is not easy due to lack of a unified measure of recruitment efficacy. The author introduces a new variable, the Recruitment Index, which represents the number of days required for an average study site in a multicenter study to recruit one analyzable patient. Once established in previous studies, an indication-specific Recruitment Index can be used for a variety of purposes, e.g. evaluation of efficacy of various recruitment strategies, planning duration of recruitment period for a new study, or projecting the number of participating sites required to supply a given number of analyzable patients within a certain period.
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Contemp Clin Trials · Aug 2005
The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement.
If randomized controlled trials (RCTs) are to fulfill their potential to allow health care providers to make informed inferences about the validity of the trials upon which they base their clinical practice, then the reporting of key methodological factors must improve. The revised Consolidated Standards for Reporting Trials (CONSORT) were developed to improve the suboptimal reporting of RCTs. We aimed to determine the extent to which RCTs report key methodological factors included in the revised CONSORT recommendations following publication of these recommendations. ⋯ RCTs reported: sequence generation 80% (95% CI 75-80%), allocation concealment 48% (95% CI 42-54%), randomization implementation 55% (95% CI 49-61%), blinding status of participants 40% (34-46%), health care providers 17% (95% CI 13-22%), outcome assessors 47% (95% CI 41-53%), data analysts 15% (10-19%), sample size justification 83% (95% CI 78-87%), method of analysis 87% (95% CI 83-91%)), and participant flow diagrams 86% (95% CI 82-90%). Although reporting of some CONSORT recommendations is high, reporting of several essential recommendations remains suboptimal. Authors need to comply with and journals need to enforce reporting of the revised CONSORT recommendations.