College of Public Health, University of South Florida, Tampa, FL, USA.
College of Nursing, University of South Florida, and Department of Nursing Research, Moffitt Cancer Center, Tampa, FL, USA.
Clin Nurs Res. 2021 Jun;30(5):680-689. doi: 10.1177/1054773820973274. Epub 2020 Nov 20.
Biomarkers may serve as objective measures in complicated grief (CG) potentially capturing responses to stress reduction treatment. This paper reports challenges in obtaining and assessing salivary cortisol and α-amylase (sAA) for a recent randomized clinical trial. Within-session changes in salivary cortisol and sAA for 54 older adults with CG who received Accelerated Resolution Therapy were compared with perceived stress measured by Subjective Units of Distress Scale. Bivariate correlations and multiple regressions examined changes in biomarkers. Protocols, study logs, and audit reports identified challenges. Challenges included obtaining unstimulated passive drool salivary samples and their analyses. Our sample of older females on multiple medications may have resulted in a perfect storm of moderating and intervening variables which affected the stress response. This paper contributes to the discussion on designing clinical trials for older adults which must account for physiologic changes, multimorbidity, and polypharmacy common in this population and makes recommendations moving forward.
生物标志物可作为复杂悲伤(CG)的客观测量指标,可能捕捉到对减轻压力治疗的反应。本文报告了在最近的一项随机临床试验中获取和评估唾液皮质醇和α-淀粉酶(sAA)时遇到的挑战。将接受加速解决治疗的 54 名 CG 老年患者的唾液皮质醇和 sAA 的会话内变化与通过主观不适量表测量的感知压力进行了比较。双变量相关和多元回归分析了生物标志物的变化。方案、研究日志和审计报告确定了挑战。挑战包括获得非刺激被动流口水唾液样本及其分析。我们的样本中,年龄较大的女性服用多种药物,可能导致调节和干预变量的完美风暴,从而影响应激反应。本文为设计针对老年人的临床试验做出了贡献,这些临床试验必须考虑到该人群中常见的生理变化、多种合并症和多药治疗,并提出了前进的建议。