What is the ideal time to begin tapering opioid agonist treatment? A protocol for a retrospective population-based comparative effectiveness study in British Columbia, Canada

Introduction
Opioid agonist treatment (OAT) tapering involves a gradual reduction in daily medication dose to ultimately reach a state of opioid abstinence. Due to the high risk of relapse and overdose after tapering, this practice is not recommended by clinical guidelines, however, clients may still request to taper off medication. The ideal time to initiate an OAT taper is not known. However, ethically, taper plans should acknowledge clients’ preferences and autonomy but apply principles of shared informed decision-making regarding safety and efficacy. Linked population-level data capturing real-world tapering practices provide a valuable opportunity to improve existing evidence on when to contemplate starting an OAT taper. Our objective is to determine the comparative effectiveness of alternative times from OAT initiation at which a taper can be initiated, with a primary outcome of taper completion, as observed in clinical practice in British Columbia (BC), Canada.

Methods and analysis
We propose a population-level retrospective observational study with a linkage of eight provincial health administrative databases in BC, Canada (01 January 2010 to 17 March 2020). Our primary outcomes include taper completion and all-cause mortality during treatment. We propose a ‘per-protocol’ target trial to compare different durations to taper initiation on the likelihood of taper completion. A range of sensitivity analyses will be used to assess the heterogeneity and robustness of the results including assessment of effectiveness and safety.

Ethics and dissemination
The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. Results will be disseminated to local advocacy groups and decision-makers, national and international clinical guideline developers, presented at international conferences and published in peer-reviewed journals electronically and in print.

Leggi
Aprile 2024

Willingness and preferences for long-acting injectable PrEP among US men who have sex with men: a discrete choice experiment

Introduction
Cabotegravir long-acting injectable HIV pre-exposure prophylaxis (LA-PrEP) was shown to be safe and effective in multiple clinical trials. Increasing uptake and persistence among populations with elevated risk for HIV acquisition, especially among men who have sex with men (MSM), is critical to HIV prevention.

Objective
This analysis aims to understand potential users’ preferences for LA-PrEP, with audience segmentation.

Design
Willingness to use and preferences for LA-PrEP were measured in HIV-negative, sexually active MSM in the 2020 American Men’s Internet Survey. Respondents answered a discrete choice experiment with paired profiles of hypothetical LA-PrEP characteristics with an opt-out option (no LA-PrEP). Conditional and mixed logit models were run; the final model was a dummy-coded mixed logit that interacted with the opt-out.

Setting
US national online sample.

Results
Among 2506 MSM respondents, most (75%) indicated a willingness to use LA-PrEP versus daily oral PrEP versus no PrEP. Respondents were averse to side effects and increasing costs and preferred increasing levels of protection. Respondents preferred a 2-hour time to obtain LA-PrEP vs 1 hour, with a strong aversion to 3 hours. Overall, there was an aversion to opting out of LA-PrEP, with variations: those with only one partner, no/other insurance or who were Black, Indigenous or People of Colour were significantly less likely to prefer LA-PrEP, while those who were Hispanic/Latino, college educated and

Leggi
Aprile 2024

Short-duration aerobic high-intensity intervals versus moderate exercise training intensity in patients with peripheral artery disease: study protocol for a randomised controlled trial (the Angiof-HIIT Study)

Introduction
Supervised exercise training is among the first-line therapies for patients with peripheral artery disease (PAD). Current recommendations for exercise include guidance focusing on claudication pain, programme and session duration, and frequency. However, no guidance is offered regarding exercise training intensity. This study aims to compare the effects of 12-week-long supervised walking exercise training (high-intensity interval training (HIIT) vs moderate-intensity exercise (MOD)) in patients with chronic symptomatic PAD.

Methods and analysis
This study is a monocentric, interventional, non-blinded randomised controlled trial. 60 patients (30 in each group) will be randomly allocated (by using the random permuted blocks) to 12 weeks (three times a week) of HIIT or MOD. For HIIT, exercise sessions will consist of alternating brief high-intensity (≥85% of the peak heart rate (HRpeak)) periods (≤60 s) of work with periods of passive rest. Patients will be asked to complete 1 and then 2 sets of 5–7 (progressing to 10–15×60 s) walking intervals. For the MOD group, exercise training sessions will consist of an alternation of periods of work performed at moderate intensity (≤76% HRpeak) and periods of passive rest. Interventions will be matched by training load. The primary outcome will be the maximal walking distance. Secondary outcomes will include functional performance, functional capacity, heath-related quality of life, self-perceived walking abilities, physical activity and haemodynamic parameters.

Ethics and dissemination
The Angiof-HIIT Study was approved by the Human Research Ethics Committee of the Canton de Vaud (study number: 2022-01752). Written consent is mandatory prior to enrolment and randomisation. The results will be disseminated via national and international scientific meetings, scientific peer-reviewed journals and social media.

Trial registration number
NCT05612945.

Leggi
Aprile 2024

New opioid prescription claims and their clinical indications: results from health administrative data in Quebec, Canada, over 14 years

Objectives
Describe new opioid prescription claims, their clinical indications and annual trends among opioid naïve adults covered by the Quebec’s public drug insurance plan (QPDIP) for the fiscal years 2006/2007–2019/2020.

Design and setting
A retrospective observational study was conducted using data collected between 2006/2007 and 2019/2020 within the Quebec Integrated Chronic Disease Surveillance System, a linkage administrative data.

Participants
A cohort of opioid naïve adults and new opioid users was created for each study year (median number=2 263 380 and 168 183, respectively, over study period).

Intervention
No.

Main outcome measure and analyses
A new opioid prescription was defined as the first opioid prescription claimed by an opioid naïve adult during a given fiscal year. The annual incidence proportion for each year was then calculated and standardised for age. A hierarchical algorithm was built to identify the most likely clinical indication for this prescription. Descriptive and trend analyses were performed.

Results
There was a 1.7% decrease of age-standardised annual incidence proportion during the study period, from 7.5% in 2006/2007 to 5.8% in 2019/2020. The decrease was highest after 2016/2017, reaching 5.5% annual percentage change. Median daily dose and days’ supply decreased from 27 to 25 morphine milligram equivalent/day and from 5 to 4 days between 2006/2007 and 2019/2020, respectively. Between 2006/2007 and 2019/2020, these prescriptions’ most likely clinical indications increased for cancer pain from 34% to 48%, for surgical pain from 31% to 36% and for dental pain from 9% to 11%. Inversely, the musculoskeletal pain decreased from 13% to 2%. There was good consistency between the clinical indications identified by the algorithm and prescriber’s specialty or user’s characteristics.

Conclusions
New opioid prescription claims (incidence, dose and days’ supply) decreased slightly over the last 14 years among QPDIP enrollees, especially after 2016/2017. Non-surgical and non-cancer pain became less common as their clinical indication.

Leggi
Aprile 2024

Mixed-methods feasibility outcomes for a novel ACT-based video game 'ACTing Minds to support mental health

Objectives
To determine the feasibility and acceptability of ‘ACTing Minds’, a novel single-player adventure video game based on acceptance and commitment therapy (ACT).

Design
A single-arm, mixed-methods repeated measures feasibility study.

Setting
Intervention and questionnaires were completed at home by participants. Semistructured interviews were also conducted at home via the Zoom platform.

Participants
Thirty-six participants were recruited into the study, 29 completed all phases of the feasibility design. Eligibility criteria required participants to be over the age of 18 and self-reporting experiencing ongoing depression, anxiety or stress.

Intervention
Participants completed a single session of the ‘ACTing Minds’ video game, lasting approximately 1 hour, designed to educate users on key principles from ACT.

Primary outcome measures
Participant recruitment and retention, questionnaire completion, long-term intervention adherence and acceptability of the intervention. Reflexive thematic analysis was conducted on semistructured interviews run immediately postintervention and 3 weeks later.

Secondary outcome measures
Measures of depression, anxiety, stress, psychological flexibility, social connectedness and well-being were assessed at baseline, immediately following intervention completion, and after a 3-week follow-up period. We used a standardised battery of questionnaires.

Primary results
Twenty-nine participants completed the study. A reflexive thematic analysis indicated that participants responded positively to the intervention and the study at all stages. Themes reflect participants’ desire for an engaging therapeutic experience, use of game for exploring emotions, as well as their perspectives on how they had applied their learning to the real world.

Secondary results
Quantitative results indicated small to large effect sizes associated with decreases in depression (p2 = 0.011), anxiety (p2 = 0.096) and stress (p2 = 0.108), and increases in psychological flexibility (p2 = 0.060), social connectedness (p2 = 0.021), well-being (p2 = 0.011) and participation in usual activities (p2 = .307).

Conclusions
Implementation of the ‘ACTing Minds’ intervention is warranted, based on both qualitative and quantitative outcomes.

Trial registration number
NCT04566042 ClinicalTrials.gov

Leggi
Marzo 2024

Long-Acting HIV Treatment Superior to Daily Oral Drugs

People with HIV-1 who received a long-acting antiretroviral treatment combining 2 drugs, cabotegravir and rilpivirine, were better able to maintain low levels of the virus compared with those who received daily oral medication, according to interim data, the National Institutes of Health (NIH) announced. The US Food and Drug Administration approved the combination of cabotegravir and rilpivirine, marketed as Cabenuva, as a once-monthly injectable for adults in 2021.

Leggi
Marzo 2024

Identifying provider, patient and practice factors that shape long-term opioid prescribing for cancer pain: a qualitative study of American and Australian providers

Introduction
Prescribing long-term opioid therapy is a nuanced clinical decision requiring careful consideration of risks versus benefits. Our goal is to understand patient, provider and context factors that impact the decision to prescribe opioids in patients with cancer.

Methods
We conducted a secondary analysis of the raw semistructured interview data gathered from 42 prescribers who participated in one of two aligned concurrent qualitative studies in the USA and Australia. We conducted a two-part analysis of the interview: first identifying all factors influencing long-term prescribing and second open coding-related content for themes.

Results
Factors that influence long-term opioid prescribing for cancer-related pain clustered under three key domains (patient-related, provider-related and practice-related factors) each with several themes. Domain 1: Patient factors related to provider–patient continuity, patient personality, the patient’s social context and patient characteristics including racial/ethnic identity, housing and socioeconomic status. Domain 2: Provider-related factors centred around provider ‘personal experience and expertise’, training and time availability. Domain 3: Practice-related factors included healthcare interventions to promote safer opioid practices and accessibility of quality alternative pain therapies.

Conclusion
Despite the differences in the contexts of the two countries, providers consider similar patient, provider and practice-related factors when long-term prescribing opioids for patients with cancer. Some of these factors may be categorised as cognitive biases that may intersect in an already disadvantaged patient and exacerbate disparities in the treatment of their pain. A more systematic understanding of these factors and how they impact the quality of care can inform appropriate interventions.

Leggi
Marzo 2024