Pain Research, Informatics, Multimorbidities, and Education (PRIME) Center, VA Connecticut Healthcare System, West Haven, CT, United States of America; Pain Management Collaboratory Coordinating Center, Yale School of Medicine, New Haven, CT, United States of America.
San Francisco VA Health Care System, San Francisco, CA, United States of America; Department of Social and Behavioral Sciences, University of California, San Francisco, San Francisco, CA, United States of America.
Contemp Clin Trials. 2021 Dec;111:106619. doi: 10.1016/j.cct.2021.106619. Epub 2021 Nov 12.
Characterizing the impacts of disruption attributable to the COVID-19 pandemic on clinical research is important, especially in pain research where psychological, social, and economic stressors attributable to the COVID-19 pandemic may greatly impact treatment effects. The National Institutes of Health - Department of Defense - Department of Veterans Affairs Pain Management Collaboratory (PMC) is a collective effort supporting 11 pragmatic clinical trials studying nonpharmacological approaches and innovative integrated care models for pain management in veteran and military health systems. The PMC rapidly developed a brief pandemic impacts measure for use across its pragmatic trials studying pain while remaining broadly applicable to other areas of clinical research. Through open discussion and consensus building by the PMC's Phenotypes and Outcomes Work Group, the PMC Coronavirus Pandemic (COVID-19) Measure was iteratively developed. The measure assesses the following domains (one item/domain): access to healthcare, social support, finances, ability to meet basic needs, and mental or emotional health. Two additional items assess infection status (personal and household) and hospitalization. The measure uses structured responses with a three-point scale for COVID-19 infection status and four-point ordinal rank response for all other domains. We recommend individualized adaptation as appropriate by clinical research teams using this measure to survey the effects of the COVID-19 pandemic on study participants. This can also help maintain utility of the measure beyond the COVID-19 pandemic to characterize impacts during future public health emergencies that may require mitigation strategies such as periods of quarantine and isolation.
描述与 COVID-19 大流行相关的中断对临床研究的影响很重要，特别是在疼痛研究中，COVID-19 大流行带来的心理、社会和经济压力可能极大地影响治疗效果。美国国立卫生研究院-国防部-退伍军人事务部疼痛管理合作研究中心（PMC）是一项集体努力，支持 11 项实用的临床试验，研究非药物治疗方法和创新的综合护理模式，以改善退伍军人和军事卫生系统的疼痛管理。PMC 迅速开发了一种简短的大流行影响措施，用于其研究疼痛的实用试验，同时广泛适用于临床研究的其他领域。通过 PMC 的表型和结局工作组的公开讨论和共识建立，PMC 冠状病毒大流行（COVID-19）措施得以迭代开发。该措施评估以下领域（一个项目/领域）：获得医疗保健、社会支持、财务状况、满足基本需求的能力以及心理或情绪健康。另外两个项目评估感染状况（个人和家庭）和住院情况。该措施使用结构化的响应和 COVID-19 感染状况的三点量表以及所有其他领域的四点有序等级响应。我们建议临床研究团队在使用该措施调查 COVID-19 大流行对研究参与者的影响时，根据需要进行个体化的调整。这也有助于在未来可能需要缓解策略（如隔离期）的公共卫生紧急情况下保持该措施的效用，以描述期间的影响。
