Abstract:
Variability in pain-related outcomes can hamper assay sensitivity of chronic pain clinical trials. Expectations of outcome in such trials may account for some of this variability, and thereby impede development of novel pain treatments. Measurement of participants\' expectations prior to initiating study treatment (active or placebo) is infrequent, variable, and often unvalidated. Efforts to optimize and standardize measurement, analysis, and management of expectations are needed. In this Focus Article, we provide an overview of research findings on the relationship between baseline expectations and pain-related outcomes in clinical trials of pharmacological and nonpharmacological pain treatments. We highlight the potential benefit of adjusting for participants\' expectations in clinical trial analyses and draw on findings from patient interviews to discuss critical issues related to measurement of expectations. We conclude with suggestions regarding future studies focused on better understanding the utility of incorporating these measures into clinical trial analyses. PERSPECTIVE: This focus article provides an overview of the relationship between participants\' baseline expectations and pain-related outcomes in the setting of clinical trials of chronic pain treatments. Systematic research focused on the measurement of expectations and the impact of adjusting for expectations in clinical trial analyses may improve assay sensitivity.
摘要:
疼痛相关结果的变异性会妨碍慢性疼痛临床试验的测定敏感性。在这些试验中对结果的期望可能是这种变异性的一部分,从而阻碍了新型疼痛治疗的发展。在开始研究治疗(活性或安慰剂)之前测量参与者的期望很少,变量,而且往往是未经验证的。努力优化和标准化测量,分析,和管理的期望是必要的。在这篇聚焦文章中,我们概述了药物和非药物疼痛治疗临床试验中基线预期与疼痛相关结局之间关系的研究结果.我们强调了在临床试验分析中调整参与者期望的潜在好处,并利用患者访谈的结果来讨论与期望测量相关的关键问题。最后,我们提出了有关未来研究的建议,重点是更好地理解将这些措施纳入临床试验分析的效用。观点:这篇重点文章概述了慢性疼痛治疗临床试验中参与者的基线预期和疼痛相关结果之间的关系。系统研究集中在预期的测量和在临床试验分析中调整预期的影响可以提高测定灵敏度。