Clinical trials : journal of the Society for Clinical Trials
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Randomized Controlled Trial
Conducting the ACTIVE randomized trial in hospice care: keys to success.
Untreated pain is common for patients at the end of life. Informal caregivers, often family or friends of patients, are responsible for working with hospice staff to provide pain management. Interdisciplinary team meetings conducted in hospices every 2 weeks provide an opportunity for hospice staff to communicate about pain management with informal caregivers of hospice patients. ⋯ The challenges of conducting randomized trials with hospice patients and caregivers can be addressed with appropriate study design, well-tested research methods, and proactive monitoring of any issues or problems.
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Randomized Controlled Trial
Parent perspectives on consent for the linkage of data to evaluate vaccine safety: a randomised trial of opt-in and opt-out consent.
We examined parents' consent preferences and understanding of an opt-in or opt-out invitation to participate in data linkage for post-marketing safety surveillance of childhood vaccines. ⋯ This trial demonstrates that informed consent for a population-based surveillance programme cannot realistically be achieved using mail-based opt-in and opt-out approaches. While recall and understanding of the study's purpose were better among parents who actively consented (opted in) compared with parents who passively consented (did not opt out), participation was substantially lower (21% vs. 96% respectively). Most parents appeared to have a poor understanding of data linkage for vaccine safety surveillance; nonetheless, they supported data linkage. They preferred a system utilising opt-out consent or no consent to one using opt-in consent.
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Randomized Controlled Trial
Addressing methodological challenges in implementing the nursing home pain management algorithm randomized controlled trial.
Unrelieved pain among nursing home (NH) residents is a well-documented problem. Attempts have been made to enhance pain management for older adults, including those in NHs. Several evidence-based clinical guidelines have been published to assist providers in assessing and managing acute and chronic pain in older adults. Despite the proliferation and dissemination of these practice guidelines, research has shown that intensive systems-level implementation strategies are necessary to change clinical practice and patient outcomes within a health-care setting. One promising approach is the embedding of guidelines into explicit protocols and algorithms to enhance decision making. ⋯ Methodological challenges are inevitable in the conduct of an RCT. The need to optimize internal validity by adhering to the study protocol is compromised by the emergent logistical issues that arise during the course of the study.
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Randomized Controlled Trial
Increasing trial efficiency by early reallocation of placebo nonresponders in sequential parallel comparison designs: application to antidepressant trials.
The sequential parallel comparison (SPC) design was proposed to improve the efficiency of psychiatric clinical trials by reducing the impact of placebo response. It consists of two consecutive placebo-controlled comparisons of which the second is only entered by placebo nonresponders from the first. Previous studies suggest that in antidepressant trials, nonresponse to placebo can already be predicted after 2 weeks of follow-up. This would allow to reduce the first phase of the SPC design to further increase its efficiency. ⋯ This study suggests that SPC designs are highly efficient alternatives to a conventional RCT in indications where placebo response is high and substantial treatment effects are established after a relatively short follow-up period (i.e., after the first SPC design phase). We conclude that SPC designs can reduce sample size requirements and increase success rates of antidepressant trials.
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Randomized Controlled Trial
Factors influencing enrollment of African Americans in the Look AHEAD trial.
Many factors have been identified that influence the recruitment of African Americans into clinical trials; however, the influence of eligibility criteria may not be widely appreciated. We used the experience from the Look AHEAD (Action for Health in Diabetes) trial screening process to examine the differential impact eligibility criteria had on the enrollment of African Americans compared to other volunteers. ⋯ Compared to non-African Americans, African American were more often ineligible for the Look AHEAD trial due to comorbid conditions. Monitoring trial eligibility criteria for differential impact, and modifying them when appropriate, may ensure greater enrollment yields.