Adapting to disruption of research during the COVID-19 pandemic while testing nonpharmacological approaches to pain management
Adapting to disruption of research during the COVID-19 pandemic while testing nonpharmacological approaches to pain management
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DOI：
10.1093/tbm/ibaa074
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发表时间：
2020-08-01
影响因子：
3.6
通讯作者：
Kerns, Robert D.
中科院分区：
文献类型：
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作者：
Coleman, Brian C.;Kean, Jacob;Kerns, Robert D.
COVID-19大流行减缓了研究进展，特别是对应对慢性疼痛等紧迫公共卫生挑战的研究产生了破坏性影响。美国国立卫生研究院（NIH）国防部（DoD）退伍军人事务部（VA）疼痛管理合作实验室（PMC）支持军队和退伍军人卫生系统中的11项大规模，多地点，嵌入式实用临床试验（PCT）。PMC迅速制定并颁布计划，以应对COVID-19疫情的关键问题。PMC跟踪并合作制定了应对COVID-19在多个领域的影响的计划，并描述了COVID-19对PCT运营的影响，包括招募延迟和研究方案修订。统一的参与者问卷将有助于随后对COVID-19对所有11种PCT的影响进行荟萃分析和交叉研究比较。大流行影响了干预措施的实施、结果、监管和伦理问题、参与者招募和研究设计。PMC采取具体措施确保科学严谨性，同时鼓励PCT的灵活性，同时密切关注最大限度地减少研究参与者，研究者和临床护理团队的负担。疼痛管理干预措施的突然变化可能会改变通过PMC PCT测量的治疗效果。通过使用统一的工具和调查，我们正在捕捉这些变化，并计划监测对研究实践和健康结果的影响。随着时间的推移，对患者报告的指标进行分析，将为慢性疼痛、心理健康和COVID-19大流行期间美国人常见的各种社会经济压力之间的潜在关系提供信息。
The COVID-19 pandemic has slowed research progress, with particularly disruptive effects on investigations of addressing urgent public health challenges, such as chronic pain. The National Institutes of Health (NIH) Department of Defense (DoD) Department of Veterans Affairs (VA) Pain Management Collaboratory (PMC) supports 11 large-scale, multisite, embedded pragmatic clinical trials (PCTs) in military and veteran health systems. The PMC rapidly developed and enacted a plan to address key issues in response to the COVID-19 pandemic. The PMC tracked and collaborated in developing plans for addressing COVID-19 impacts across multiple domains and characterized the impact of COVID-19 on PCT operations, including delays in recruitment and revisions of study protocols. A harmonized participant questionnaire will facilitate later meta-analyses and cross-study comparisons of the impact of COVID-19 across all 11 PCTs. The pandemic has affected intervention delivery, outcomes, regulatory and ethics issues, participant recruitment, and study design. The PMC took concrete steps to ensure scientific rigor while encouraging flexibility in the PCTs, while paying close attention to minimizing the burden on research participants, investigators, and clinical care teams. Sudden changes in the delivery of pain management interventions will probably alter treatment effects measured via PMC PCTs. Through the use of harmonized instruments and surveys, we are capturing these changes and plan to monitor the impact on research practices, as well as on health outcomes. Analyses of patient-reported measures over time will inform potential relationships between chronic pain, mental health, and various socioeconomic stressors common among Americans during the COVID-19 pandemic.