Bachhuber Marcus A, Arnsten Julia H, Starrels Joanna L, Cunningham Chinazo O
Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, New York.
Cannabis Cannabinoid Res. 2018 Mar 1;3(1):45-53. doi: 10.1089/can.2017.0051. eCollection 2018.
Regulatory barriers limit clinical trials of medical cannabis in the United States. Longitudinal cohort studies may be one feasible alternative that could yield clinically relevant information. Willingness to participate in such studies is not known. In October 2016, we surveyed a convenience sample of patients with chronic pain from two New York registered organizations (responsible for growing, processing, distributing, and retailing medical cannabis products). After a vignette describing a longitudinal cohort study involving weekly patient-reported outcomes and quarterly assessments of physical functioning and urine and blood tests, we asked about respondents' willingness to participate. We examined willingness to participate, duration of participation, and frequency of data collections overall and by subgroups, using multivariable logistic regression models. Of 405 respondents (estimated response rate: 30%), 54% were women and 81% were white non-Hispanic. Neuropathy was the most common pain condition (67%) followed by inflammatory bowel disease (19%). Of respondents, 94% (95% CI 92-97%) thought that the study should be done, 85% (95% CI 81-88%) would definitely or probably enroll if asked, 76% (95% CI 72-81%) would participate for ≥1 year, and 59% (95% CI 54-64%) would respond to questions at least daily. Older age was the only factor associated with lower willingness to participate, lower willingness to participate for ≥1 year, and lower willingness to respond to questions at least daily. Nearly all respondents were supportive of the proposed study and most reported that they would enroll if asked. Enhanced engagement with older individuals may be needed to promote equal enrollment. Recruitment for longitudinal cohort studies with frequent data collection appears feasible in this patient population.
监管障碍限制了美国医用大麻的临床试验。纵向队列研究可能是一种可行的替代方法，能够产生具有临床相关性的信息。目前尚不清楚患者参与此类研究的意愿。2016年10月，我们对来自纽约两个注册机构（负责种植、加工、分销和零售医用大麻产品）的慢性疼痛患者进行了便利抽样调查。在向受访者介绍了一项纵向队列研究（涉及患者每周报告的结果以及对身体功能、尿液和血液的季度评估）后，我们询问了他们参与研究的意愿。我们使用多变量逻辑回归模型，总体上以及按亚组检查了参与意愿、参与持续时间和数据收集频率。在405名受访者中（估计回应率：30%），54%为女性，81%为非西班牙裔白人。神经病变是最常见的疼痛病症（67%），其次是炎症性肠病（19%）。在受访者中，94%（95%置信区间92 - 97%）认为该研究应该进行，85%（95%置信区间81 - 88%）表示如果被邀请肯定或可能会参加，76%（95%置信区间72 - 81%）愿意参与≥1年，59%（95%置信区间54 - 64%）愿意至少每天回答问题。年龄较大是与参与意愿较低、参与≥1年的意愿较低以及至少每天回答问题的意愿较低相关的唯一因素。几乎所有受访者都支持拟议的研究，并且大多数人表示如果被邀请会参加。可能需要加强与老年人的沟通以促进平等参与。在这一患者群体中，招募进行频繁数据收集的纵向队列研究似乎是可行的。
