Major longitudinal study launched to assess changes in quality-of-life outcomes for patients prescribed medicinal cannabis
Lead researcher Associate Professor Claudia Rutherford. Top of page: Flowering cannabis credit My 450 Tours, Wikimedia Commons.
Researchers at the University of Sydney have launched The QUality of life Evaluation STudy (The QUEST Initiative), a wide-ranging, longitudinal study for medicinal cannabis patients.
The QUEST Initiative aims to be one of the world's largest studies examining quality of life outcomes in patients prescribed medicinal cannabis. The study aims to recruit at least 2,100 patients - the minimum sample size (number of recruited patients) calculated to achieve statistical relevance - by June 2021 with potential to extend this study internationally.
"What makes our study unique is the comprehensive suite of patient-reported outcomes - or PROs - being assessed in patients prescribed medicinal cannabis," said study lead Associate Professor Claudia Rutherford.
The QUEST Initiative seeks to assess changes in patient conditions and symptoms using self-reported quality-of-life outcomes. Information on patient mobility, functionality, pain or discomfort, anxiety and depression, medication requirements and ongoing health costs will be collected and analysed.
The Federal Minister for Health, the Hon. Greg Hunt, commented:
"The QUEST Initiative represents a significant Australian contribution to the global need for reliable, objective and clinically-relevant quality of life data for patients accessing medicinal cannabis treatments for a broad range of chronic conditions.
"It is also commendable to see an entirely home-grown Australian study supported by a leading Australian higher educational institution, advocacy groups and industry participants.
"I would like to congratulate the University of Sydney and study supporters on making such an important clinical contribution and helping to drive increased understanding around medicinal cannabis for Australian prescribers and patients - I look forward to reviewing the results of the study in due course."
About the study
The study is currently open and planned to close in March 2022. It is the first study of a comprehensive suite of quality-of-life measures in Australia of patients prescribed medicinal cannabis for all allowable conditions under the Special Access Scheme.
The study is investigator-led, with principal investigator Associate Professor Claudia Rutherford, deputy director of the Sydney Quality of Life Office and researcher in the Faculty of Medicine and Health, being responsible for protocol and methodology design, analysis and reporting of study outcomes in line with the study's ethics approval, Human Research Ethics Committee (HREC).
The QUEST Initiative is guided by an Advisory Group and endorsed by a range of national bodies, such as MS Research Australia, Chronic Pain Australia, Arthritis Australia, Epilepsy Action Australia and Health Insurance Fund of Australia (HIF).
Associate Professor Rutherford noted the study aims were two-fold:
- To track changes in patient-reported outcomes (PRO) over one year in a large cohort of patients prescribed medicinal cannabis products for a variety of conditions.
- A secondary objective is to compare differences in PROs between patients who access medical cannabis for different health conditions.
"Medicinal cannabis has been studied in a broad range of chronic conditions and diseases but quality-of-life studies are limited. The QUEST study is unique in its approach, emphasising both health economic and quality of life measures, rather than effectiveness for a specific symptom or condition," Associate Professor Rutherford said.
"By taking this approach, The QUEST Initiative may be able to provide future critical insights into the health of a patient over time and help us better understand whether the introduction of medicinal cannabis delivers cost-effective improvements to a patient's wellbeing."
The study has been designed to accommodate a large cohort of patients with a broad range of chronic conditions and diseases being eligible such as chronic pain, cancer pain, neuropathic pain, insomnia, anxiety, multiple sclerosis and epilepsy.
Declaration
The study is funded by Australian medicinal cannabis manufacturer Little Green Pharma (LGP). LGP provided technical advice on LGP products and their administration, which was incorporated into the study design. Data collection and analysis will be carried out independently.
The study is conducted by researchers at the University of Sydney. It is approved by the University of Sydney's Human Research Ethics Committee (project number 2020/589).
