Understanding Australian general practice patients' decisions to deprescribe antidepressants in the WiserAD trial: a realist informed approach.

OBJECTIVES: To evaluate how an approach to antidepressant deprescribing works, for whom, and in what contexts by (1) examining the experiences and perceptions of the approach for antidepressant users, (2) identifying the mechanisms of the approach and (3) describing what contexts are associated with antidepressant tapering. DESIGN: This mixed methods study was informed by the principles of realist evaluation and was conducted in the first 3 months of participation in the WiserAD randomised control trial. SETTING: General practice, Victoria, Australia. PARTICIPANTS: 13 antidepressant users from general practice participating in the WiserAD trial for antidepressant deprescribing. INTERVENTION: A patient-facing, web-based structured support tool that consists of a personalised tapering schedule, an action plan for managing withdrawal symptoms, a daily mood, sleep and activity tracker and mental health nurse support. PRIMARY/SECONDARY OUTCOME MEASURES: The outcomes of the study were revealed on data analysis as per a realist evaluation approach which tests and refines an initial programme theory. RESULTS: The contexts of learnt coping skills, knowledge and perceptions of antidepressants and feeling well were evident. Outcomes were intention to commence, initiation of deprescribing and successful completion of deprescribing. Key mechanisms for antidepressant deprescribing were (1) initiation of the deprescribing discussion; (2) patient self-efficacy; (3) provision of structured guidance; (4) coaching; (5) mood, sleep and activity tracking and (6) feelings of safety during the tapering period. CONCLUSIONS: The WiserAD approach to antidepressant deprescribing supported participants to commence and/or complete tapering. The refined programme theory presents the WiserAD pragmatic framework for the application of antidepressant deprescribing in clinical practice. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT05355025; ACTRN12622000567729; ISRCTN11562922; Pre-results.

The PRESIDE (PhaRmacogEnomicS In DEpression) Trial: a double-blind randomised controlled trial of pharmacogenomic-informed prescribing of antidepressants on depression outcomes in patients with major depressive disorder in primary care.

BACKGROUND: The evidence for the clinical utility of pharmacogenomic (PGx) testing is growing, and guidelines exist for the use of PGx testing to inform prescribing of 13 antidepressants. Although previous randomised controlled trials of PGx testing for antidepressant prescribing have shown an association with remission of depression in clinical psychiatric settings, few trials have focused on the primary care setting, where most antidepressant prescribing occurs. METHODS: The PRESIDE Trial is a stratified double-blinded randomised controlled superiority trial that aims to evaluate the impact of a PGx-informed antidepressant prescribing report (compared with standard prescribing using the Australian Therapeutic Guidelines) on depressive symptoms after 12 weeks, when delivered in primary care. Six hundred seventy-two patients aged 18-65 years of general practitioners (GPs) in Victoria with moderate to severe depressive symptoms, measured using the Patient Health Questionnaire-9 (PHQ-9), will be randomly allocated 1:1 to each arm using a computer-generated sequence. Participants and GPs will be blinded to the study arm. The primary outcome is a difference between arms in the change of depressive symptoms, measured using the PHQ-9 after 12 weeks. Secondary outcomes include a difference between the arms in change in PHQ-9 score at 4, 8 and 26 weeks, proportion in remission at 12 weeks, a change in side effect profile of antidepressant medications, adherence to antidepressant medications, change in quality of life and cost-effectiveness of the intervention. DISCUSSION: This trial will provide evidence as to whether PGx-informed antidepressant prescribing is clinically efficacious and cost-effective. It will inform national and international policy and guidelines about the use of PGx to select antidepressants for people with moderate to severe depressive symptoms presenting in primary care. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry ACTRN12621000181808. Registered on 22 February 2021.

Corrigendum to: Use of electronic medical records to monitor the safe and effective prescribing of medicinal cannabis: is it feasible?

BACKGROUND: General practitioners are well positioned to contribute to the pharmacovigilance of medical cannabis via the general practice electronic medical record (EMR). The aim of this research is to interrogate de-identified patient data from the Patron primary care data repository for reports of medicinal cannabis to ascertain the feasibility of using EMRs to monitor medicinal cannabis prescribing in Australia. METHODS: EMR rule-based digital phenotyping of 1 164 846 active patients from 109 practices was undertaken to investigate reports of medicinal cannabis use from September 2017 to September 2020. RESULTS: Eighty patients with 170 prescriptions of medicinal cannabis were identified in the Patron repository. Reasons for prescription included anxiety, multiple sclerosis, cancer, nausea, and Crohn's disease. Nine patients showed symptoms of a possible adverse event, including depression, motor vehicle accident, gastrointestinal symptoms, and anxiety. CONCLUSIONS: The recording of medicinal cannabis effects in the patient EMR provides potential for medicinal cannabis monitoring in the community. This is especially feasible if monitoring were to be embedded into general practitioner workflow.

Self-reported reasons for reducing or stopping antidepressant medications in primary care: thematic analysis of the diamond longitudinal study.

BACKGROUND: Current treatment guidelines advise that the deprescribing of antidepressants should occur around 6 months post-remission of symptoms. However, this is not routinely occurring in clinical practice, with between 30% and 50% of antidepressant users potentially continuing treatment with no clinical benefit. To support patients to deprescribe antidepressant treatment when clinically appropriate, it is important to understand what is important to patients when making the decision to reduce or cease antidepressants in a naturalistic setting. AIM: The current study aimed to describe the self-reported reasons primary care patients have for reducing or stopping their antidepressant medication. METHODS: Three hundred and seven participants in the diamond longitudinal study reported taking an SSRI/SNRI over the life of the study. Of the 307, 179 reported stopping or tapering their antidepressant during computer-assisted telephone interviews and provided a reason for doing so. A collective case study approach was used to collate the reasons for stopping or tapering. FINDINGS: Reflexive thematic analysis of patient-reported factors revealed five overarching themes; 1. Depression; 2. Medication; 3. Healthcare system; 4. Psychosocial, and; 5. Financial. These findings are used to inform suggestions for the development and implementation of antidepressant deprescribing discussions in clinical practice.

General Practice Patients' Experiences and Perceptions of the WiserAD Structured Web-Based Support Tool for Antidepressant Deprescribing: Protocol for a Mixed Methods Case Study With Realist Evaluation.

BACKGROUND: Research suggests that the rapid increase in worldwide antidepressant use is mainly due to a rise in long-term and potentially inappropriate use. It has been suggested that 1 in 3 antidepressant users among general practice patients are no longer experiencing clinical benefits from their medication and should commence deprescribing. However there are many barriers to antidepressant deprescribing for both patients and clinicians, which adds to the complex nature of reducing or ceasing the medication. As such, antidepressant deprescribing does not routinely occur in clinical practice. Evidence-based supports and interventions for safe and successful antidepressant deprescribing are needed to assist patients and their doctors. Interventions should also include an understanding of how an intervention works, why it works, and whom it is for. OBJECTIVE: This study aims to evaluate how the WiserAD approach to antidepressant deprescribing works, whom it is for, and the underlying circumstances by (1) examining the experiences and perceptions of WiserAD among antidepressant users, (2) identifying the underlying mechanisms of the WiserAD approach to antidepressant deprescribing, and (3) describing in what contexts and to what extent the underlying mechanisms of WiserAD are suited for antidepressant users. METHODS: A mixed methods case study with realist evaluation will be conducted among participants in the WiserAD randomized controlled trial for antidepressant deprescribing. Quantitative data will be obtained from up to 12 participants from the intervention and control arms at baseline and 3-month follow-up. Baseline data will be used to characterize the sample using descriptive statistics. Paired samples t tests will also be performed to compare responses between baseline and 3-month follow-up for participant self-management, skills, confidence and knowledge, beliefs about medicines, current emotional health, and well-being symptoms. Qualitative data from the same participants will be collected via narrative interview at 3-month follow-up. Quantitative and qualitative data will be converged to form a "case," and analysis will be conducted within each case with comparisons made across multiple cases. RESULTS: Recruitment of participants commenced in October 2022 and will be completed by March 2023. Analysis will be completed by June 2023. CONCLUSIONS: To our knowledge, this will be the first realist evaluation of an antidepressant deprescribing intervention in general practice. Findings from this evaluation may assist in the implementation of the WiserAD approach to antidepressant deprescribing in routine clinical practice. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/42526.

Developing and internally validating a prediction model for total knee replacement surgery in patients with osteoarthritis.

Objective: The objective of this study was to develop and internally validate a clinical algorithm for use in general practice that predicts the probability of total knee replacement (TKR) surgery within the next five years for patients with osteoarthritis. The purpose of the model is to encourage early uptake of first-line treatment strategies in patients likely to undergo TKR and to provide a cohort for the development and testing of novel interventions that prevent or delay the progression to TKR. Method: Electronic health records (EHRs) from 201,462 patients with osteoarthritis aged 45 years and over from 483 general practices across Australia were linked with records from the Australian Orthopaedic Association National Joint Replacement Registry and the National Death Index. A Fine and Gray competing risk prediction model was developed using these data to predict the risk of TKR within the next five years. Results: During a follow-up time of 5 years, 15,979 (7.9%) patients underwent TKR and 13,873 (6.9%) died. Predictors included in the final algorithm were age, previous knee replacement, knee surgery (other than TKR), prescribing of osteoarthritis medication in the 12 months prior, comorbidity count and diagnosis of a mental health condition. Optimism corrected model discrimination was 0.67 (95% CI: 0.66 to 0.67) and model calibration acceptable. Conclusion: The model has the potential to reduce some of the economic burden associated with TKR in Australia. External validation and further optimisation of the algorithm will be carried out prior to implementation within Australian general practice EHR systems.

Economic evaluation of a Decision Support Tool to guide intensity of mental health care in general practice: the Link-me pragmatic randomised controlled trial.

BACKGROUND: This paper reports on the cost-effectiveness evaluation of Link-me - a digitally supported, systematic approach to triaging care for depression and anxiety in primary care that uses a patient-completed Decision Support Tool (DST). METHODS: The economic evaluation was conducted alongside a parallel, stratified individually randomised controlled trial (RCT) comparing prognosis-matched care to usual care at six- and 12-month follow-up. Twenty-three general practices in three Australian Primary Health Networks recruited 1,671 adults (aged 18 - 75 years), predicted by the DST to have minimal/mild or severe depressive or anxiety symptoms in three months. The minimal/mild prognostic group was referred to low intensity services. Participants screened in the severe prognostic group were offered high intensity care navigation, a model of care coordination. The outcome measures included in this evaluation were health sector costs (including development and delivery of the DST, care navigation and other healthcare services used) and societal costs (health sector costs plus lost productivity), psychological distress [Kessler Psychological Distress Scale (K10)] and quality adjusted life years (QALYs) derived from the EuroQol 5-dimension quality of life questionnaire with Australian general population preference weights applied. Costs were valued in 2018-19 Australian dollars (A$). RESULTS: Across all participants, the health sector incremental cost-effectiveness ratio (ICER) of Link-me per point decrease in K10 at six months was estimated at $1,082 (95% CI $391 to $6,204) increasing to $2,371 (95% CI $191 to Dominated) at 12 months. From a societal perspective, the ICER was estimated at $1,257/K10 point decrease (95% CI Dominant to Dominated) at six months, decreasing to $1,217 (95% CI Dominant to Dominated) at 12 months. No significant differences in QALYs were detected between trial arms and the intervention was dominated (less effective, more costly) based on the cost/QALY ICER. CONCLUSIONS: The Link-me approach to stepped mental health care would not be considered cost-effective utilising a cost/QALY outcome metric commonly adopted by health technology assessment agencies. Rather, Link-me showed a trend toward cost-effectiveness by providing improvement in mental health symptoms, measured by the K10, at an additional cost. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ANZCTRN 12617001333303.

Dementia Risk Reduction in Primary Care: A Scoping Review of Clinical Guidelines Using a Behavioral Specificity Framework.

BACKGROUND: Primary care practitioners are being called upon to work with their patients to reduce dementia risk. However, it is unclear who should do what with whom, when, and under what circumstances. OBJECTIVE: This scoping review aimed to identify clinical guidelines for dementia risk reduction (DRR) in primary care settings, synthesize the guidelines into actionable behaviors, and appraise the guidelines for specificity. METHODS: Terms related to "dementia", "guidelines", and "risk reduction" were entered into two academic databases and two web search engines. Guidelines were included if they referred specifically to clinical practices for healthcare professionals for primary prevention of dementia. Included guidelines were analyzed using a directed content analysis method, underpinned by the Action-Actor-Context-Target-Time framework for specifying behavior. RESULTS: Eighteen guidelines were included in the analysis. Together, the guidelines recommended six distinct clusters of actions for DRR. These were to 1) invite patients to discuss DRR, 2) identify patients with risk factors for dementia, 3) discuss DRR, 4) manage dementia risk factors, 5) signpost to additional support, and 6) follow up. Guidelines recommended various actors, contexts, targets, and times for performing these actions. Together, guidelines lacked specificity and were at times contradictory. CONCLUSION: Currently available guidelines allow various approaches to promoting DRR in primary care. Primary care teams are advised to draw on the results of the review to decide which actions to undertake and the locally appropriate actors, contexts, targets, and times for these actions. Documenting these decisions in more specific, local guidelines for promoting DRR should facilitate implementation.

Use of electronic medical records to monitor the safe and effective prescribing of medicinal cannabis: is it feasible?

BACKGROUND: General practitioners are well positioned to contribute to the pharmacovigilance of medical cannabis via the general practice electronic medical record (EMR). The aim of this research is to interrogate de-identified patient data from the Patron primary care data repository for reports of medicinal cannabis to ascertain the feasibility of using EMRs to monitor medicinal cannabis prescribing in Australia. METHODS: EMR rule-based digital phenotyping of 1 164 846 active patients from 109 practices was undertaken to investigate reports of medicinal cannabis use from September 2017 to September 2020. RESULTS: Eighty patients with 170 prescriptions of medicinal cannabis were identified in the Patron repository. Reasons for prescription included anxiety, multiple sclerosis, cancer, nausea, and Crohn's disease. Nine patients showed symptoms of a possible adverse event, including depression, motor vehicle accident, gastrointestinal symptoms, and anxiety. CONCLUSIONS: The recording of medicinal cannabis effects in the patient EMR provides potential for medicinal cannabis monitoring in the community. This is especially feasible if monitoring were to be embedded into general practitioner workflow.

Economic evaluation of the Target-D platform to match depression management to severity prognosis in primary care: A within-trial cost-utility analysis.

BACKGROUND: Target-D, a new person-centred e-health platform matching depression care to symptom severity prognosis (minimal/mild, moderate or severe) has demonstrated greater improvement in depressive symptoms than usual care plus attention control. The aim of this study was to evaluate the cost-effectiveness of Target-D compared to usual care from a health sector and partial societal perspective across 3-month and 12-month follow-up. METHODS AND FINDINGS: A cost-utility analysis was conducted alongside the Target-D randomised controlled trial; which involved 1,868 participants attending 14 general practices in metropolitan Melbourne, Australia. Data on costs were collected using a resource use questionnaire administered concurrently with all other outcome measures at baseline, 3-month and 12-month follow-up. Intervention costs were assessed using financial records compiled during the trial. All costs were expressed in Australian dollars (A$) for the 2018-19 financial year. QALY outcomes were derived using the Assessment of Quality of Life-8D (AQoL-8D) questionnaire. On a per person basis, the Target-D intervention cost between $14 (minimal/mild prognostic group) and $676 (severe group). Health sector and societal costs were not significantly different between trial arms at both 3 and 12 months. Relative to a A$50,000 per QALY willingness-to-pay threshold, the probability of Target-D being cost-effective under a health sector perspective was 81% at 3 months and 96% at 12 months. From a societal perspective, the probability of cost-effectiveness was 30% at 3 months and 80% at 12 months. CONCLUSIONS: Target-D is likely to represent good value for money for health care decision makers. Further evaluation of QALY outcomes should accompany any routine roll-out to assess comparability of results to those observed in the trial. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616000537459).

The impact of removing financial incentives and/or audit and feedback on chlamydia testing in general practice: A cluster randomised controlled trial (ACCEPt-able).

BACKGROUND: Financial incentives and audit/feedback are widely used in primary care to influence clinician behaviour and increase quality of care. While observational data suggest a decline in quality when these interventions are stopped, their removal has not been evaluated in a randomised controlled trial (RCT), to our knowledge. This trial aimed to determine whether chlamydia testing in general practice is sustained when financial incentives and/or audit/feedback are removed. METHODS AND FINDINGS: We undertook a 2 × 2 factorial cluster RCT in 60 general practices in 4 Australian states targeting 49,525 patients aged 16-29 years for annual chlamydia testing. Clinics were recruited between July 2014 and September 2015 and were followed for up to 2 years or until 31 December 2016. Clinics were eligible if they were in the intervention group of a previous cluster RCT where general practitioners (GPs) received financial incentives (AU$5-AU$8) for each chlamydia test and quarterly audit/feedback reports of their chlamydia testing rates. Clinics were randomised into 1 of 4 groups: incentives removed but audit/feedback retained (group A), audit/feedback removed but incentives retained (group B), both removed (group C), or both retained (group D). The primary outcome was the annual chlamydia testing rate among 16- to 29-year-old patients, where the numerator was the number who had at least 1 chlamydia test within 12 months and the denominator was the number who had at least 1 consultation during the same 12 months. We undertook a factorial analysis in which we investigated the effects of removal versus retention of incentives (groups A + C versus groups B + D) and the effects of removal versus retention of audit/feedback (group B + C versus groups A + D) separately. Of 60 clinics, 59 were randomised and 55 (91.7%) provided data (group A: 15 clinics, 11,196 patients; group B: 14, 11,944; group C: 13, 11,566; group D: 13, 14,819). Annual testing decreased from 20.2% to 11.7% (difference -8.8%; 95% CI -10.5% to -7.0%) in clinics with incentives removed and decreased from 20.6% to 14.3% (difference -7.1%; 95% CI -9.6% to -4.7%) where incentives were retained. The adjusted absolute difference in treatment effect was -0.9% (95% CI -3.5% to 1.7%; p = 0.2267). Annual testing decreased from 21.0% to 11.6% (difference -9.5%; 95% CI -11.7% to -7.4%) in clinics where audit/feedback was removed and decreased from 19.9% to 14.5% (difference -6.4%; 95% CI -8.6% to -4.2%) where audit/feedback was retained. The adjusted absolute difference in treatment effect was -2.6% (95% CI -5.4% to -0.1%; p = 0.0336). Study limitations included an unexpected reduction in testing across all groups impacting statistical power, loss of 4 clinics after randomisation, and inclusion of rural clinics only. CONCLUSIONS: Audit/feedback is more effective than financial incentives of AU$5-AU$8 per chlamydia test at sustaining GP chlamydia testing practices over time in Australian general practice. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12614000595617.

Prevalence of burnout among GPs: a systematic review and meta-analysis.

BACKGROUND: Burnout is a work-related syndrome documented to have negative consequences for GPs and their patients. AIM: To review the existing literature concerning studies published up to December 2020 on the prevalence of burnout among GPs in general practice, and to determine GP burnout estimates worldwide. DESIGN AND SETTING: Systematic literature search and meta-analysis. METHOD: Searches of CINAHL Plus, Embase, MEDLINE, PsycINFO, and Scopus were conducted to identify published peer-reviewed quantitative empirical studies in English up to December 2020 that have used the Maslach Burnout Inventory - Human Services Survey to establish the prevalence of burnout in practising GPs (that is, excluding GPs in training). A random-effects model was employed. RESULTS: Wide-ranging prevalence estimates (6% to 33%) across different dimensions of burnout were reported for 22 177 GPs across 29 countries were reported for 60 studies included in this review. Mean burnout estimates were: 16.43 for emotional exhaustion; 6.74 for depersonalisation; and 29.28 for personal accomplishment. Subgroup and meta-analyses documented that country-specific factors may be important determinants of the variation in GP burnout estimates. Moderate overall burnout cut-offs were found to be determinants of the variation in moderate overall burnout estimates. CONCLUSION: Moderate to high GP burnout exists worldwide. However, substantial variations in how burnout is characterised and operationalised has resulted in considerable heterogeneity in GP burnout prevalence estimates. This highlights the challenge of developing a uniform approach, and the importance of considering GPs' work context to better characterise burnout.

Patient reported self-help strategies and the perceived benefits for managing sub-threshold depressive symptoms: A nested qualitative study of Australian primary care attendees.

BACKGROUND: Subthreshold depression is common in primary care, but there is little information about the self-help strategies that patients use and the perceived benefits of these. AIM: This study sought to elicit the self-help strategies that primary care attendees identified as beneficial for the self-management of subthreshold depressive symptoms and the implications for general practitioners. METHOD: Semi-structured telephone interviews were conducted with 14 people (April-May 2017) from the Target-D randomised controlled trial (RCT). Target-D investigated whether using a patient-centred clinical prediction tool and an e-health platform to match mental health management options to prognosis was beneficial for improving depressive symptoms at 3 months compared to usual care. Interviews were thematically analysed to identify self-help strategies and their perceived benefits. RESULTS: Four overarching domains for the self-management strategies were identified: social, cognitive, behavioural and restorative. Interviewees reported using strategies across multiple domains, which included undertaking enjoyable, immersive activities, that provided relief from automatic negative thoughts and had a perceived cognitive benefit. Differences in the perceived sense of agency were noted around the self-regulation of mood, which indicated more explicit direction to patient-identified self-help management strategies by general practitioners for some may be of benefit in routine care. CONCLUSION: Some of the reported self-management strategies aligned with evidence-based approaches such as physical activity and mindfulness for mental health symptom management. These findings can inform low-intensity interventions within stepped care models for mental health in primary care, social prescribing models and, help to guide the management of patients by GPs for subthreshold depression.

Implementing dementia risk reduction in primary care: views of enrollees in the Preventing Dementia Massive Open Online Course.

There is a push for greater promotion of dementia risk reduction (DRR) by primary care practitioners (PCPs). The aims of this study were to understand the views of non-medically trained Australian contributors in a Massive Open Online Course (MOOC) about dementia prevention regarding the role of PCPs in promoting DRR and to consider the implications of those views for developing implementation strategies. Discussion board posts of MOOC enrollees were analysed regarding the actions that organisations, communities and/or governments should take to help people work towards DRR. Of the 1641 eligible contributors to the discussion, 160 (10%) indicated that PCPs had a role in promoting DRR. This subset of participants particularly wanted earlier identification of risk by PCPs and a discussion about DRR. Some participants thought PCPs did not currently prioritise DRR, lacked knowledge about DRR and faced Medicare and resource restrictions to promoting DRR. We suggest that PCPs need: better publicity for their role in promoting DRR; to prioritise DRR; knowledge about DRR; and to take advantage of existing opportunities to promote DRR quickly. The findings of this study should be considered when attempting to implement DRR guidelines in primary care.

Assessing the suitability of general practice electronic health records for clinical prediction model development: a data quality assessment.

BACKGROUND: The use of general practice electronic health records (EHRs) for research purposes is in its infancy in Australia. Given these data were collected for clinical purposes, questions remain around data quality and whether these data are suitable for use in prediction model development. In this study we assess the quality of data recorded in 201,462 patient EHRs from 483 Australian general practices to determine its usefulness in the development of a clinical prediction model for total knee replacement (TKR) surgery in patients with osteoarthritis (OA). METHODS: Variables to be used in model development were assessed for completeness and plausibility. Accuracy for the outcome and competing risk were assessed through record level linkage with two gold standard national registries, Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and National Death Index (NDI). The validity of the EHR data was tested using participant characteristics from the 2014-15 Australian National Health Survey (NHS). RESULTS: There were substantial missing data for body mass index and weight gain between early adulthood and middle age. TKR and death were recorded with good accuracy, however, year of TKR, year of death and side of TKR were poorly recorded. Patient characteristics recorded in the EHR were comparable to participant characteristics from the NHS, except for OA medication and metastatic solid tumour. CONCLUSIONS: In this study, data relating to the outcome, competing risk and two predictors were unfit for prediction model development. This study highlights the need for more accurate and complete recording of patient data within EHRs if these data are to be used to develop clinical prediction models. Data linkage with other gold standard data sets/registries may in the meantime help overcome some of the current data quality challenges in general practice EHRs when developing prediction models.

Implementation of medicinal cannabis in Australia: innovation or upheaval? Perspectives from physicians as key informants, a qualitative analysis.

OBJECTIVE: We sought to explore physician perspectives on the prescribing of cannabinoids to patients to gain a deeper understanding of the issues faced by prescriber and public health advisors in the rollout of medicinal cannabis. DESIGN: A thematic qualitative analysis of 21 in-depth interviews was undertaken to explore the narrative on the policy and practice of medicinal cannabis prescribing. The analysis used the Diffusion of Innovations (DoI) theoretical framework to model the conceptualisation of the rollout of medicinal cannabis in the Australian context. SETTING: Informants from the states and territories of Victoria, New South Wales, Tasmania, Australian Capital Territory, and Queensland in Australia were invited to participate in interviews to explore the policy and practice of medicinal cannabis prescribing. PARTICIPANTS: Participants included 21 prescribing and non-prescribing key informants working in the area of neurology, rheumatology, oncology, pain medicine, psychiatry, public health, and general practice. RESULTS: There was an agreement among many informants that medicinal cannabis is, indeed, a pharmaceutical innovation. From the analysis of the informant interviews, the factors that facilitate the diffusion of medicinal cannabis into clincal practice include the adoption of appropriate regulation, the use of data to evaluate safety and efficacy, improved prescriber education, and the continuous monitoring of product quality and cost. Most informants asserted the widespread assimilation of medicinal cannabis into practice is impeded by a lack of health system antecedents that are required to facilitate safe, effective, and equitable access to medicinal cannabis as a therapeutic. CONCLUSIONS: This research highlights the tensions that arise and the factors that influence the rollout of cannabis as an unregistered medicine. Addressing these factors is essential for the safe and effective prescribing in contemporary medical practice. The findings from this research provides important evidence on medicinal cannabis as a therapeutic, and also informs the rollout of potential novel therapeutics in the future.

Deprescribing intervention activities mapped to guiding principles for use in general practice: a scoping review.

OBJECTIVE: To identify and characterise activities for deprescribing used in general practice and to map the identified activities to pioneering principles of deprescribing. SETTING: Primary care. DATA SOURCES: Medline, EMBASE (Ovid), CINAHL, Australian New Zealand Clinical Trials Registry (ANZCTR), Clinicaltrials.gov, ISRCTN registry, OpenGrey, Annals of Family Medicine, BMC Family Practice, Family Practice and British Journal of General Practice (BJGP) from inception to the end of June 2021. STUDY SELECTION: Included studies were original research (randomised controlled trial, quasi-experimental, cohort study, qualitative and case studies), protocol papers and protocol registrations. DATA EXTRACTION: Screening and data extraction was completed by one reviewer; 10% of the studies were independently reviewed by a second reviewer. Coding of full-text articles in NVivo was conducted and mapped to five deprescribing principles. RESULTS: Fifty studies were included. The most frequently used activities were identification of appropriate patients for deprescribing (76%), patient education (50%), general practitioners (GP) education (48%), and development and use of a tapering schedule (38%). Six activities did not align with the five deprescribing principles. As such, two principles (engage practice staff in education and appropriate identification of patients, and provide feedback to staff about deprescribing occurrences within the practice) were added. CONCLUSION: Activities and guiding principles for deprescribing should be paired together to provide an accessible and comprehensive guide to deprescribing by GPs. The addition of two principles suggests that practice staff and practice management teams may play an instrumental role in sustaining deprescribing processes within clinical practice. Future research is required to determine the most of effective activities to use within each principle and by whom.

The CORE study-An adapted mental health experience codesign intervention to improve psychosocial recovery for people with severe mental illness: A stepped wedge cluster randomized-controlled trial.

BACKGROUND: Mental health policies outline the need for codesign of services and quality improvement in partnership with service users and staff (and sometimes carers), and yet, evidence of systematic implementation and the impacts on healthcare outcomes is limited. OBJECTIVE: The aim of this study was to test whether an adapted mental health experience codesign intervention to improve recovery-orientation of services led to greater psychosocial recovery outcomes for service users. DESIGN: A stepped wedge cluster randomized-controlled trial was conducted. SETTING AND PARTICIPANTS: Four Mental Health Community Support Services providers, 287 people living with severe mental illnesses, 61 carers and 120 staff were recruited across Victoria, Australia. MAIN OUTCOME MEASURES: The 24-item Revised Recovery Assessment Scale (RAS-R) measured individual psychosocial recovery. RESULTS: A total of 841 observations were completed with 287 service users. The intention-to-treat analysis found RAS-R scores to be similar between the intervention (mean = 84.7, SD= 15.6) and control (mean = 86.5, SD= 15.3) phases; the adjusted estimated difference in the mean RAS-R score was -1.70 (95% confidence interval: -3.81 to 0.40; p = .11). DISCUSSION: This first trial of an adapted mental health experience codesign intervention for psychosocial recovery outcomes found no difference between the intervention and control arms. CONCLUSIONS: More attention to the conditions that are required for eight essential mechanisms of change to support codesign processes and implementation is needed. PATIENT AND PUBLIC INVOLVEMENT: The State consumer (Victorian Mental Illness Awareness Council) and carer peak bodies (Tandem representing mental health carers) codeveloped the intervention. The adapted intervention was facilitated by coinvestigators with lived-experiences who were coauthors for the trial and process evaluation protocols, the engagement model and explanatory model of change for the trial.

When should matching be used in the design of cluster randomized trials?

For cluster randomized trials (CRTs) with a small number of clusters, the matched-pair (MP) design, where clusters are paired before randomizing one to each trial arm, is often recommended to minimize imbalance on known prognostic factors, add face-validity to the study, and increase efficiency, provided the analysis recognizes the matching. Little evidence exists to guide decisions on when to use matching. We used simulation to compare the efficiency of the MP design with the stratified and simple designs, based on the mean confidence interval width of the estimated intervention effect. Matched and unmatched analyses were used for the MP design; a stratified analysis was used for the stratified design; and analyses without and with post-stratification adjustment for factors that would otherwise have been used for restricted allocation were used for the simple design. Results showed the MP design was generally the most efficient for CRTs with 10 or more pairs when the correlation between cluster-level outcomes within pairs (matching correlation) was moderate to strong (0.3-0.5). There was little gain in efficiency for the MP or stratified designs compared to simple randomization when the matching correlation was weak (0.05-0.1). For trials with four pairs of clusters, the simple and stratified designs were more efficient than the MP design because greater degrees of freedom were available for the analysis, although an unmatched analysis of the MP design recovered precision for weak matching correlations. Practical guidance on choosing between the MP, stratified, and simple designs is provided.