Data collection has become an integral part of all sectors of industry, including the health sector. This practice holds the potential to support hypothesis generation, study feasibility, and provide insight regarding how to address problems under real-world conditions. However, this potential is consistently limited due to a lack of academic freedom perpetuated by academic-industry partnerships, as academic researchers are regularly required to collect and present data in alignment with business models. As a result, this collaboration often fails, limiting the use of relevant data for the greater good of scientific innovation.
This is particularly true in the health sector; however, there is the potential to change this. The authors of a recently published journal article aimed to develop a practice-based research network focused on cannabis science to create a de-identified database for analyses that could support hypothesis generation, study feasibility estimation, and facilitate recruitment into future research studies.
The Aims of the Study
The use of practice-based research networks was introduced widely in the 1970s to provide data on primary care health concerns. They have since developed to serve multiple functions, including focusing on patient-oriented outcomes, improving delivery and quality of care, community health improvement, and patient engagement. The researchers identified Florida, USA, as the setting for their Complementary Care Practice-Based Research Network (CC-PBRN), using de-identified electronic health records from a private medical cannabis health system.
Currently, there are no such practice-based research networks in Florida that focus on complementary care in general, or on medial cannabis specifically. In response, the researchers aimed to describe the process utilised in the development of the Complementary Care Practice-Based Research Network (CC-PBRN), present baseline descriptive characteristics of the practice-based research network, and discuss the challenges and lessons learned in initiating an academic-industry partnership.
Design and Methods
The CC-PBRN was developed as an academic-industry partnership between Florida State University’s intervention Research Advancing Care Equity Lab (FSU-iRACE) and Medical Marijuana Treatment Clinics of Florida (MMTC). Over a number of meetings, both parties collaborated to complete a strengths, weaknesses, opportunities, and threats (SWOT) analysis which served as the foundation for the mission of the collaborative partnership.
All currently active patients (n = 43,802) with a certified qualifying medical condition were included in the final analyses. In order to qualify for medical cannabis certification, patients in Florida must receive an official diagnosis of one of the following conditions: a) Cancer; b) Epilepsy; c) Glaucoma; d) Positive status for immunodeficiency virus; e) Amyotrophic lateral sclerosis; h) Crohn’s disease; I) Parkinson’s disease; j) Multiple sclerosis; OR k) Medical conditions in the same class as those listed; l) A diagnosed terminal condition; m) Chronic non-cancer pain. The CC-PBRN used data from electronic health records, including diagnoses, procedures, place of service, vital signs, and patient-reported outcomes.
Symptom reduction was assessed using data from medical records, obtained during the follow-up patient visit. This patient-reported outcome did not ask about specific symptoms; instead, patients were asked to indicate reduction in severity of symptoms since their initial visit.
Patient-Reported Symptom Reduction
Currently, the CC-PBRN has 43,802 active patients from 24 Florida clinics. The majority of patients (73.1%) were certified for a comparable medical condition; post-traumatic stress disorder (PTSD) was the second most common qualifying condition (12%), followed by cancer (8%).
Almost two-thirds (65.2%) of patients had been recertified for medical cannabis. In total, 28,783 patients had recertification data, 27.8% of which reported an 80% or greater reduction in symptoms. Only 2.2% of patients failed to see an improvement in their symptoms.
Strengths and Limitations of the CC-PBRN
Medical cannabis was legalised in Florida for a limited number of conditions in January 2017; however, the researchers note that there remains a significant gap in the knowledge needed to manage medical cannabis care due to the limited research that has been conducted in this area, and specifically on patient-reported outcomes (PRO) of use. Therefore, the CC-PBRN was designed to serve as an incubator for PRO research in Florida and throughout the US.
The authors of this study concede that, while the CC-PBRN has a number of strengths, there are also several limitations. First of all, the current electronic health records system does not force responses for certain demographic data; therefore, there is currently incomplete data for race, education, and income level. Secondly, only a general indication of symptom reduction is reported, meaning that researchers can only approximate symptoms to the nearest condition allowed by law. Furthermore, symptom reduction was not measured using a validated symptom reduction measure.
Nonetheless, the authors conclude that “the CC-PBRN is a vital research network that provides numerous resources for the advancement of complementary care and cannabis science.” The CC-PBRN is a representative sample of medical cannabis users and offers the opportunity to engage in research with diverse populations across the state of Florida. This network could assist with hypothesis generation and study feasibility estimations and provide support services for implementing grant-funded research in a real-world practice-based setting.
The data collected through the CC-PBRN can be used to inform and guide patient-centered care, clinical decision-making, and health policy decisions, including informing clinical practice, clinical guidelines, and health policy, supporting drug approval, pricing and reimbursement decisions, informing clinical and shared decision-making, and informing consent. In conclusion, the CC-PBRN and other patient data networks are “poised to make a significant scientific contribution” to further our understanding of best practice for medical cannabis as we await the conclusion of high-quality clinical trials.
At Sapphire Medical Clinics, patients can contribute to the improvement of knowledge on medical cannabis through enrolling in the Sapphire Access Scheme which enables them to receive appointments for the cost of £50, whilst also contributing data to the UK Medical Cannabis Registry.