Abstract
BackgroundDespite repeated calls by medical associations to gather evidence on the harms and benefits of cannabis, there are ongoing methodological challenges to conducting observational and clinical studies on cannabis, including a high rate of patients that are lost to follow-up (LTFU). This study explores factors potentially associated with retention in a large prospective study of Canadian medical cannabis patients, with the goal of reducing the probability that patients will be lost to follow-up in future cannabis research.MethodsThe Tilray Observational Patient Study (TOPS) was a multi-site, prospective study assessing the impact of medical cannabis over 6 months in a broad population of authorized Canadian cannabis patients. The study took place from 2016 to 19, and we conducted a series of exploratory analyses including a Kaplan–Meier survival analysis and logistic regressions to assess the potential association between study retention and variables including patient characteristics, cannabis and prescription drug use, quality of life, and the legalization of non-medical cannabis.ResultsOverall, 1011 participants were included in this analysis, contributing 287 patient-years of data. Retention was 728 (72%) at 3 months, and 419 (41.4%) at 6 months. Our analyses found significantly lower adjusted odds of retention following legalization (AOR 0.28, 95% CI 0.18–0.41), and in patients that used prescription opioids at baseline (AOR 0.62, 95% CI 0.46–0.85), while increased odds of retention were found in patients with a higher baseline psychological score (AOR 1.43, 95% CI 1.08–1.90) or that used anti-seizure medications at baseline (AOR 1.91, 95% CI 1.30–2.81).DiscussionTOPS provided a unique opportunity to examine patient characteristics and other variables that may be associated with retention in prospective medical cannabis studies. Our findings highlight some of the challenges of conducting medical cannabis research at a time when patients have a multitude of cannabis access options, including legal adult dispensaries and a robust illicit market. High LTFU rates can impact the validity of studies, and potentially lead to misestimations of the harms and benefits of medical cannabis use. Despite being a multi-site prospective study, this was a convenience sample, thereby limiting the generalizability of these findings. Additionally, data regarding the use of cannabis was self-reported by patients, so is subject to potential recall bias.ConclusionWe found evidence that external policy changes that affect access to cannabis such as the legalization of non-medical adult use and patient characteristics associated with patient physical/psychological capacity can impact retention in prospective medical cannabis studies. Evidence-based strategies to reduce study burden on participants, such as minimizing in-person visits by providing digitized internet-based surveys and phone or telemedicine follow-up options as well as ensuring adequate participant compensation could improve retention. Additionally, policy-related changes aimed at improving access to medical cannabis, including increased cost-coverage and community-based distribution, could encourage patients to remain in the federal medical cannabis program and thereby reduce LTFU in associated studies.
Highlights
Despite repeated calls by medical associations to gather evidence on the harms and benefits of can‐ nabis, there are ongoing methodological challenges to conducting observational and clinical studies on cannabis, including a high rate of patients that are lost to follow-up (LTFU)
In this study, we found that non-medical cannabis legalization was independently associated with retention in the Tilray Observational Patient Survey
Cannabis legalization in Canada has successfully shifted the regulation of cannabis from a predominantly criminal justice approach to one focused on public health and harm reduction
Summary
Despite repeated calls by medical associations to gather evidence on the harms and benefits of can‐ nabis, there are ongoing methodological challenges to conducting observational and clinical studies on cannabis, including a high rate of patients that are lost to follow-up (LTFU). There are a number of challenges to conducting highquality cannabis research in Canada and in other jurisdictions These include social stigma resulting from the long-standing international prohibition on cannabis possession and use (Belle-Isle et al 2014; Bottorff et al 2013; Lucas, 2009), a lack of funding and regulatory obstacles and associated delays National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board onPopulation Health and Public Health Practice; Committee on the Health Effects of Marijuanav, 2017; Geary 2019), and methodological difficulties, such as the inability to blind THC-based products in controlled studies due to its potential for impairment (Russo 2016; National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on the Health Effects of Marijuana, 2017). Legalizing the adult, non-medical use of cannabis in Canada in October 2018 has significantly changed how medical and non-medical adult users access cannabis, and this may have subsequent impacts on recruitment, adherence, and retention in prospective medical cannabis studies in Canada
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