Clinical trials : journal of the Society for Clinical Trials
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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.