It has been estimated that at least 85% of all clinical research fails to generate sufficient impact, partly due to the prioritisation of research questions or studies deemed irrelevant to clinicians and patients. Therefore, patient contribution to the design and implementation of research studies – known as Patient and Public Involvement (PPI) – is increasingly being considered an important part of research development. PPI is utilised to tailor clinical research toward patient priorities and feedback. This helps to reduce research ‘waste’ and financial costs.
PPI can also play an important role in the development of much-needed evidence on the safety and efficacy of medical cannabis. Global barriers and the complex pharmacology of the cannabis plant are factors that continue to limit researchers’ ability to conduct randomised controlled trials. In the absence of this high-quality clinical evidence, real-world data can play an important role in developing our understanding of cannabis-based medicine.
The UK Medical Cannabis Registry (UKMCR)
In 2019, Sapphire Medical Clinics launched the UK Medical Cannabis Registry (UKMCR) – the largest patient registry of its kind in Europe. The UKMCR was established to collect real-world evidence of the outcomes of patients prescribed medical cannabis for various indications in the UK. Over the last few months, an increasing number of studies have been published by researchers at Sapphire Medical Clinics on conditions including inflammatory bowel disease (IBD), depression, and treatment-resistant paediatric epilepsy.
While such data helps to provide novel insights into the outcomes of these patients, whether the methods of collection are acceptable to participants and whether the study priorities align with those of patients remain unseen. Therefore, the authors of a recent study aimed to “assess the acceptability and ease of utilising the patient-facing data collection platform for the UK Medical Cannabis Registry.”
Design and Methods of the Study
A cross-sectional, online survey was conducted between 18th August and 3rd November 2021, with patients who had enrolled in the UK Medical Cannabis Registry. The survey included 17 questions: nine ‘Yes’ or ‘No’ questions, three questions with a five-point Likert scale, and one question asking patients to rank a list of priorities for future research. The questionnaire was distributed to all patients enrolled in the UKMCR – excluding those who had been enrolled for fewer than 30 days.
Results of the Study
A total of 600 participants completed the questionnaire, 554 of which reported that they had utilised the remote electronic portal to capture adverse events, clinical efficacy measures or patient-reported outcome measures (PROMs). The vast majority of patients who used the portal to record their medications (n = 301; 54.3%) reported that they found the process easy. Similarly, most of these patients (n = 261; 86.7%) found it easy to input the route of administration. Of the 52 participants (8.67%) who recorded an adverse event, 38 (73.1%) found it easy to do so.
These results showed that most patients found the data collection platform easy to use. This supports the use of remote data collection systems as a means to reduce barriers to participation by making enrolment and the reporting of outcomes more convenient to patients.
The majority of patients strongly agreed or agreed that it was important to contribute to medical cannabis research so that the effects of the treatment can be better understood (n = 556; 92.6%) or to improve patient access (n = 583; 97.2%). Most patients (n = 553; 92.2%) also strongly agreed or agreed that contributing to the UKMCR would impact the medical care of future patients.
Finally, participants were asked to rank a list of six pre-specified research priorities, with the first choice being the top priority and the sixth choice being the last priority. Nineteen of the 600 participants did not answer this question. The top priority, selected by 59.3% (n = 357) was ‘Assessing the impact of medical cannabis on quality of life generally’; this was selected as the second priority by 20.2% (n = 121). An additional open-ended question asked patients to contribute additional research priorities. The most popular theme in these responses was research into more conditions (n = 39, 34.2%), including depression, anxiety, dementia, cancer, and Tourette’s syndrome.
Conclusions
While the majority of patients found most aspects of the remote data collection platform easy to use, the researchers identified several areas that could be improved upon. These included incorporating predictive text to help with challenging medication names or specific adverse events. To address patients having difficulty accessing the link for self-reporting adverse events, clinicians can also now directly report these into the Registry if reported verbally during a consultation.
With regard to patient priorities of medical cannabis research, these findings mirror the results of a 2019 study (though the sample used in this study was much smaller); namely that more research is needed into various conditions to fully ascertain the potential of cannabis-based medicines.
However, a paper published in 2019 collated priority research considerations from an international group of cannabis experts. These included: determining the effect of route of administration, optimizing cannabinoid concentrations and individual dosing, investigating long-term effects of cannabis use, and lastly, any drug interactions with medical cannabis. This highlights a difference in perceived priorities between patients and academics/physicians when it comes to future research in this area.
Nonetheless, the results of this study showed that the UK Medical Cannabis Registry is deemed important to medical cannabis research by participating patients and that the platform is easy to use for said patients. The authors note that the findings of this study will help to inform future analyses of the UKMCR which “must incorporate validated assessments of health-related quality of life and condition-specific patient-reported outcome measures to ensure they are tailored toward patient priorities, with the aim to increase patient recruitment, retention, and satisfaction.”
