Routine outcome monitoring and feedback in alcohol and other drug treatment: A qualitative study of client perspectives on implementation.

INTRODUCTION: Routine outcome monitoring (ROM) and feedback is an evidence-supported strategy for evaluating alcohol and other drug (AOD) treatment outcomes. However, the implementation of ROM and feedback into AOD services remains a significant challenge. Research aimed at understanding client perspectives on ROM and feedback is needed to facilitate successful implementation. This study examined experiences with and perceptions of ROM and feedback in a sample of clients receiving AOD treatment. METHODS: Interviews and online surveys were conducted with N = 26 people (13 male; Mage = 36.12 years, SD = 10.29) enrolled in an AOD treatment program in Australia. Data analysis of the transcripts was guided by thematic analysis, while descriptive statistics were used to analyse quantitative survey data. RESULTS: Four major themes were identified in the qualitative data: (i) ROM and feedback is valuable to AOD treatment; (ii) clear and concise outcome measures with an integrated feedback loop are vital to reliable ROM; (iii) desire for visual and verbal feedback that highlights progress; and (iv) ROM and feedback can be emotionally challenging. DISCUSSION AND CONCLUSIONS: Participants valued ROM when it was clearly integrated within AOD treatment and they received feedback on their responses. Potential facilitators to implementing and improving the provision of ROM and feedback in AOD treatment include: (i) a clear, treatment-based rationale to foster client buy-in for ROM and maximise AOD treatment benefit; (ii) brief outcome measure surveys; and (iii) graphical visualisations of ROM feedback.

Colchicine for secondary prevention of ischaemic stroke and atherosclerotic events: a meta-analysis of randomised trials.

Background: Guidelines recommend low-dose colchicine for secondary prevention in cardiovascular disease, but uncertainty remains concerning its efficacy for stroke, efficacy in key subgroups and about uncommon but serious safety outcomes. Methods: In this trial-level meta-analysis, we searched bibliographic databases and trial registries form inception to May 16, 2024. We included randomised trials of colchicine for secondary prevention of ischaemic stroke and major adverse cardiovascular events (MACE: ischaemic stroke, myocardial infarction, coronary revascularisation, or cardiovascular death). Secondary outcomes were serious safety outcomes and mortality. A fixed-effect inverse-variance model was used to generate a pooled estimate of relative risk (RR) with 95% confidence intervals (CI). This study is registered with PROSPERO, CRD42024540320. Findings: Six trials involving 14,934 patients with prior stroke or coronary disease were included. In all patients, colchicine compared with placebo or no colchicine reduced the risk for ischaemic stroke by 27% (132 [1.8%] events versus 186 [2.5%] events, RR 0.73 [95% CI 0.58-0.90]) and MACE by 27% (505 [6.8%] events versus 693 [9.4%] events, with RR 0.73 [0.65-0.81]). Efficacy was consistent in key subgroups (females versus males, age below versus above 70, with versus without diabetes, statin versus non-statin users). Colchicine was not associated with an increase in serious safety outcomes: hospitalisation for pneumonia (109 [1.5%] versus 106 [1.5%], RR 0.99 [0.76-1.30]), cancer (247 [3.5%] versus 255 [3.6%], RR 0.97 [0.82-1.15]), and gastro-intestinal events (153 [2.1%] versus 135 [1.9%]), RR 1.15 [0.91-1.44]. There was no difference in all-cause death (201 [2.7%] versus 181 [2.4%], RR 1.09 [0.89-1.33]), cardiovascular death (70 [0.9%] versus 80 [1.1%], RR 0.89 [0.65-1.23]), or non-cardiovascular death (131 [1.8%] versus 101 [1.4%], RR 1.26 [0.98-1.64]). Interpretation: In patients with prior stroke or coronary disease, colchicine reduced ischaemic stroke and MACE, with consistent treatment effect in key subgroups, and did not increase serious safety events or death. Funding: There was no funding source for this study.

New South Wales alcohol and other drug service providers' perceptions of the relative importance of client variables for determining treatment need.

INTRODUCTION: This study examines alcohol and other drug (AOD) service providers' perceptions of the most important variables (client complexity and demographic) for determining treatment need and intensity of intervention. METHODS: Online cross-sectional survey of N = 188 clinicians/service managers working in AOD services across metropolitan and regional/rural New South Wales, Australia. Participants ranked the importance of demographic and family factors, substance use, physical health, mental health, functioning and activities of daily living and youth-specific variables in identifying treatment need (five-point Likert scales). RESULTS: More than 90% of participants ranked 43 out 56 potential variables as 'very important'/'essential' in identifying treatment need. The 10 variables most ranked as 'very important'/'essential' were 'pregnant or breastfeeding' (95.2%), 'suicide/self-harm' (95.2%), 'overdose risk' (94.7%), 'abuse/neglect' (among youth/adolescent populations; 94.1%), 'mental health severity' (93.6%), 'dependent children' (93.1%), 'co-existing mental health concerns' (93.0%), 'hospitalisations due to mental health' (92.5%), 'child protection concerns' (among youth/adolescent populations; 92.2%) and 'disability' (91.5%). The 10 variables most commonly ranked as 'slightly important'/'not at all important' included 'citizenship' (63.3%), 'sex' (59.6%), 'country of birth' (54.8%), 'highest education' (50.0%), 'sexual orientation' (44.1%), 'relationship status' (33.5%), 'gender' (31.4%), 'transport' (28.2%), 'employment' (23.9%) and 'refugee status' (24.0%). Some ratings differed by geographic location (metropolitan vs. regional/rural) and job role (allied health worker, nurse, doctor or manager). DISCUSSION AND CONCLUSIONS: This study provides insight into service providers' perceptions of treatment need and intensity associated with a range of client factors. It is a first step towards improvements in routine data collections that are used to inform treatment planning.

Risk of major adverse cardiovascular events and all-cause mortality under treatment with GLP-1 RAs or the dual GIP/GLP-1 receptor agonist tirzepatide in overweight or obese adults without diabetes: a systematic review and meta-analysis.

Background: Among the currently approved antiobesity medications, the glucagon-like-peptide-1 receptor-agonists (GLP-1 RAs) liraglutide and semaglutide, and the dual glucose-dependent-insulinotropic-polypeptide (GIP)/GLP-1 RA tirzepatide have been suggested to reduce cardiovascular-risk in overweight or obesity without diabetes. Objectives: The objective of this study was to evaluate the cardio- and neuroprotective potential of these novel agents in the nondiabetic overweight/obese adult population. Data sources and methods: A systematic review and meta-analysis of randomized-controlled clinical trials (RCTs) was performed to estimate the risk of major adverse cardiovascular events (MACE), all-cause and cardiovascular mortality in overweight or obese adults without diabetes treated with GLP-1 or GIP/GLP-1 RAs (vs placebo). Secondary outcomes included the risk of myocardial infarction (MI) and stroke. Results: Sixteen RCTs (13 and 3 on GLP-1 RAs and tirzepatide, respectively) comprising 28,168 participants were included. GLP-1 or GIP/GLP-1 RAs reduced MACE (odds ratio (OR): 0.79; 95% confidence interval (CI): 0.71-0.89; p < 0.01; I 2 = 0) and all-cause mortality (OR: 0.80; 95% CI: 0.70-0.92; p < 0.01; I 2 = 0), while there was a trend toward lower cardiovascular-mortality (OR: 0.84; 95% CI: 0.71-1.01; p = 0.06; I 2 = 0%) compared to placebo. Additionally, GLP-1 or GIP/GLP-1 RAs reduced the odds of MI (OR: 0.72; 95% CI: 0.61-0.86; p < 0.01; I 2 = 0%) and nonfatal-MI (OR: 0.72; 95% CI: 0.61-0.85; p < 0.01; I 2 = 0%); while no associations between antiobesity treatment and fatal-MI, stroke, nonfatal, or fatal stroke were uncovered. Conclusion: GLP-1 and GIP/GLP-1 RAs reduce cardiovascular-risk and all-cause mortality in overweight or obese adults without diabetes. Additionally, GLP-1 RAs and GIP/GLP-1 RAs attenuate the risk of MI. Since data on stroke are still limited, future RCTs are warranted to evaluate the neuroprotective potential of these novel antiobesity agents. Trial registration: PROSPERO CRD42024515966.

Online SMART Recovery mutual-help groups: a comparison of the characteristics and experiences of men living in rural and urban regions of Australia.

INTRODUCTION: Harms arising from alcohol and other drug (AOD) use are disproportionately felt by men living in rural locations. The detrimental impact of AOD use is compounded by a range of barriers to help-seeking. Online recovery support services (including mutual-help groups) are increasingly used to reach people who might not otherwise seek support for AOD use. Scant research examines the experiences of men attending online mutual-help groups, with the little available evidence focused on 12-step approaches and people living in urban areas. This short communication compared the characteristics and experiences of rural and urban men attending online Self-Management and Recovery Training (SMART Recovery) mutual-help groups in Australia. METHODS: A link to a voluntary online questionnaire was automatically provided at the end of each online group as part of routine data collection. Questions assessed participants' demographics, main reason for attending, engagement, experiences and perceived utility of the group. This study is a secondary analysis examining data provided by male attendees located in rural (n=259) and urban (n=996) areas. RESULTS: Alcohol use for both rural and urban attendees (73% v 66.8%) was the most frequently reported reason for attending SMART Recovery groups. Rural attendees were older than their urban counterparts (p<0.001) and were less likely to endorse 'other' drug use as a reason for attending (28.6% v 16.6%, p<0.001). Participants reported a high level of satisfaction with online SMART Recovery groups. No significant differences were found between the two groups. Rural and urban men reported that they felt welcome (93.1% v 95.1%) and supported (90% vs 92.5%), had the opportunity to contribute to discussions (91.5% v 92.1%), and felt the group was well facilitated (91.1% v 94.4%). Rural and urban attendees also experienced the groups as helpful (88.8% v 91.8%), took away practical strategies (86.5% v 85.2%) and planned to continue to attend the groups in the future (91.1% v 92.3%). Around a quarter of rural (20.8%) and urban (27.0%) attendees experienced technical difficulties during the meeting. DISCUSSION AND CONCLUSION: This study contributes new knowledge regarding similarities and differences in the experience of online SMART Recovery groups from the perspective of men living in rural and urban areas. Despite around a quarter of participants experiencing technical difficulties, their self-reported engagement, experience and perceived utility of the online group were highly rated. Online recovery support services provide a promising option for reaching men who experience issues with their AOD use, particularly in rural areas where access to face-to-face services is limited.

Predictors of alcohol and other drug treatment completion among young people accessing residential and community-based treatment: A retrospective analysis of routinely collected service data.

BACKGROUND AND AIMS: Young people accessing alcohol and other drug (AOD) treatment experience high rates of treatment disengagement, contributing to poorer outcomes. To improve outcomes, it is important to identify factors associated with treatment retention. This study measured the relationships between client characteristics, treatment characteristics, clinical severity measures and completion of treatment among young people. DESIGN, SETTING AND PARTICIPANTS: This study was a retrospective analysis of routinely collected data set in residential- and community-based AOD services in New South Wales, Australia. Routinely collected data from the Network of Alcohol and Other Drug Agencies' (NADA) database were used. Included individuals were aged 10-24 years and accessed treatment between 2012 and 2023 (n = 17 474). MEASUREMENTS: Variables included client-related characteristics, service characteristics and baseline measures of clinical severity [Kessler-10 (K10), EUROHIS-QoL, severity of dependence scale (SDS)]. Multivariable binary logistic regression models assessed the relationships between these characteristics and treatment completion. FINDINGS: Rates of treatment completion were highest among adolescents in community-based treatment (57%) and lowest among young adults in residential treatment (35%). Polysubstance use was negatively associated with treatment completion among adolescents [adjusted odds ratio (adjOR) = 0.71, P < 0.001] and adults (adjOR = 0.70, P < 0.001) in community-based treatment, and adolescents in residential treatment (adjOR = 0.62, P = 0.006), as was housing insecurity (adolescents in community treatment, adjOR = 0.61, P = 0.001; adults in community treatment, adjOR = 0.77, P = 0.002; adolescents in residential treatment, adjOR = 0.42, P = 0.005). Attending youth-specific services was associated with higher treatment completion rates among adults in community-based (adjOR = 1.81, P < 0.001) and residential treatment (adjOR = 1.72, P < 0.001). Varying correlates of treatment completion were identified throughout treatment groups, reflecting the differences in population and/or needs across contexts. CONCLUSIONS: In New South Wales, Australia, fewer than half of young people accessing alcohol and other drug treatment between 2012 and 2023 completed treatment, and completion rates were lower among those facing barriers such as polysubstance use and housing insecurity.

Patterns of substance use recovery following residential treatment: A repeated measures latent profile analysis.

INTRODUCTION: Ongoing improvement to residential treatment for substance use disorders is critical as it typically targets people with the highest need. Assessing multiple recovery indicators, such as cravings and mental health, at intake and following discharge is important in evaluating treatment effectiveness. To refine services, research should explore whether there are subgroups of individuals with different patterns of recovery following treatment. METHODS: Participants (n = 554) were attending Australian Salvation Army residential treatment services for substance use issues. Data were collected by surveys at intake and 3-month post-discharge ('early recovery'). Recovery indicators were cravings, confidence to resist substance use and the Depression, Anxiety and Stress Scale. Subgroups of individuals based on these recovery indicators ('profiles') were identified using repeated measures latent profile analysis. RESULTS: Five profiles were identified, three profiles improved over time (81.4%) and two (18.6%) deteriorated across all indicators. These two profiles had the poorest mental health and addiction scores at intake and reported shorter time in treatment compared to the three profiles showing improvement. There were no demographic or substance type differences between profiles. DISCUSSION AND CONCLUSIONS: By considering initial severity and multiple recovery indicators at early recovery, this study suggests that individuals at-risk of poor early recovery can be identified at intake. This opens opportunities for tailored treatment approaches to address both mental health and substance use, thereby potentially improving treatment outcomes and reducing the risk of relapse.

Systematic review of treatment completion rates and correlates among young people accessing alcohol and other drug treatment.

BACKGROUND AND AIMS: Treatment completion is associated with improved alcohol and other drug (AOD) treatment outcomes. Unfortunately, treatment disengagement is common, particularly among young people. We reviewed and synthesised research on AOD treatment completion and/or early disengagement among young people. METHODS: We conducted a systematic review and meta-analysis of studies reporting on completion rates and/or early disengagement from psychosocial AOD treatment among adolescents and young adults. An overall estimated treatment completion rate was calculated using inverse-variance random effects meta-analysis, and random-effects meta-regression was used to identify between-study level moderators of completion rate. We completed a narrative review summarising literature on early treatment disengagement and within-study level correlates of treatment completion. Study quality was assessed using the EPHPP. RESULTS: Of the 6158 studies screened, we retained 410 for full text review and included 98 studies in the review. Treatment completion rates were reported in 88 studies, and early disengagement rates were reported in 13. The estimated overall treatment completion rate was 59 % (95 % CI=57-61 %), with experimental studies reporting higher rates of completion than observational studies. There was limited evidence for demographic or substance-related correlates of treatment completion. Contingency management was associated with increased completion rates, as was family-based intervention. CONCLUSIONS: Disengagement from AOD treatment among youth populations is common and contributes to poor treatment outcomes. Existing research has yielded little consensus on the factors associated with treatment completion. The use of contingency management strategies and involving family/social supports in treatment were identified as potential avenues for promoting ongoing treatment engagement.

Women and opioid use disorder treatment: A scoping review of experiences, use of patient-reported experience measures, and integration of person-centred care principles.

BACKGROUND: Patient-reported experience measures (PREMs) are an important aspect of assessing and improving women's experiences of person-centred care during treatment for Opioid Use Disorder (OUD). This scoping review aimed to 1) examine the extent, type, and characteristics of evidence regarding women's OUD treatment experiences, and 2) describe the extent to which PREMs and person-centred care principles are incorporated within research methods. METHODS: Following Joanna Briggs Institute guidelines and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR), we conducted a scoping review to identify peer-reviewed articles on women's OUD treatment experiences. Data were extracted from 39 included studies and synthesised based on study design, method of assessment/analysis (including use of PREMs), key findings, and the integration of person-centred care principles. RESULTS: Analysis of included studies revealed a predominance of qualitative research focused on women's experiences of pharmacological OUD treatment (methadone and/or buprenorphine) in Western countries. Women in these studies reported predominantly negative or mixed experiences of treatment. Few studies used validated PREMs and there was a lack of direct assessment or focus on recognised person-centred care principles. However, common categories of outcomes/findings identified in results across studies broadly aligned with person-centred care principles (e.g., fast access to reliable healthcare, effective treatment by trusted professionals), emphasising their applicability to women's experiences of treatment. CONCLUSIONS: Although there has been an increased focus on women's experiences of treatment for OUD in recent years, results highlighted room for improvement regarding the systematic and comprehensive assessment of women's experiences across different contexts. Given the often negative or mixed experiences reported by women, an increased focus on assessing service provision through a person-centred care lens (including utilising PREMs) may allow for service improvements or adaptations targeted towards the needs and experiences of women.

A phase 3 randomised double-blind placebo-controlled trial of mirtazapine as a pharmacotherapy for methamphetamine use disorder: a study protocol for the Tina Trial.

BACKGROUND: There are no approved pharmacotherapies for methamphetamine use disorder. Two preliminary phase 2 randomised controlled trials have found mirtazapine, a tetracyclic antidepressant, to be effective in reducing methamphetamine use. The proposed Tina Trial is the first phase 3 placebo-controlled randomised trial to examine the effectiveness and safety of mirtazapine as an outpatient pharmacotherapy for methamphetamine use disorder. METHODS: This is a multi-site phase 3 randomised, double-blind, placebo-controlled parallel trial. Participants are randomly allocated (1:1) to receive either mirtazapine (30 mg/day for 12 weeks) or matched placebo, delivered as a take-home medication. The target population is 340 people aged 18-65 years who have moderate to severe methamphetamine use disorder. The trial is being conducted through outpatient alcohol and other drug treatment clinics in Australia. The primary outcome is measured as self-reported days of methamphetamine use in the past 4 weeks at week 12. Secondary outcomes are methamphetamine-negative oral fluid samples, depressive symptoms, sleep quality, HIV risk behaviour and quality of life. Other outcomes include safety (adverse events), tolerability, and health service use. Medication adherence is being monitored using MEMS® Smart Caps fitted to medication bottles. DISCUSSION: This trial will provide information on the safety and effectiveness of mirtazapine as a pharmacotherapy for methamphetamine use disorder when delivered as an outpatient medication in routine clinical practice. If found to be safe and effective, this trial will support an application for methamphetamine use disorder to be included as a therapeutic indication for the prescription of mirtazapine. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12622000235707. Registered on February 9, 2022.

Tenecteplase versus standard of care for minor ischaemic stroke with proven occlusion (TEMPO-2): a randomised, open label, phase 3 superiority trial.

BACKGROUND: Individuals with minor ischaemic stroke and intracranial occlusion are at increased risk of poor outcomes. Intravenous thrombolysis with tenecteplase might improve outcomes in this population. We aimed to test the superiority of intravenous tenecteplase over non-thrombolytic standard of care in patients with minor ischaemic stroke and intracranial occlusion or focal perfusion abnormality. METHODS: In this multicentre, prospective, parallel group, open label with blinded outcome assessment, randomised controlled trial, adult patients (aged ≥18 years) were included at 48 hospitals in Australia, Austria, Brazil, Canada, Finland, Ireland, New Zealand, Singapore, Spain, and the UK. Eligible patients with minor acute ischaemic stroke (National Institutes of Health Stroke Scale score 0-5) and intracranial occlusion or focal perfusion abnormality were enrolled within 12 h from stroke onset. Participants were randomly assigned (1:1), using a minimal sufficient balance algorithm to intravenous tenecteplase (0·25 mg/kg) or non-thrombolytic standard of care (control). Primary outcome was a return to baseline functioning on pre-morbid modified Rankin Scale score in the intention-to-treat (ITT) population (all patients randomly assigned to a treatment group and who did not withdraw consent to participate) assessed at 90 days. Safety outcomes were reported in the ITT population and included symptomatic intracranial haemorrhage and death. This trial is registered with ClinicalTrials.gov, NCT02398656, and is closed to accrual. FINDINGS: The trial was stopped early for futility. Between April 27, 2015, and Jan 19, 2024, 886 patients were enrolled; 369 (42%) were female and 517 (58%) were male. 454 (51%) were assigned to control and 432 (49%) to intravenous tenecteplase. The primary outcome occurred in 338 (75%) of 452 patients in the control group and 309 (72%) of 432 in the tenecteplase group (risk ratio [RR] 0·96, 95% CI 0·88-1·04, p=0·29). More patients died in the tenecteplase group (20 deaths [5%]) than in the control group (five deaths [1%]; adjusted hazard ratio 3·8; 95% CI 1·4-10·2, p=0·0085). There were eight (2%) symptomatic intracranial haemorrhages in the tenecteplase group versus two (<1%) in the control group (RR 4·2; 95% CI 0·9-19·7, p=0·059). INTERPRETATION: There was no benefit and possible harm from treatment with intravenous tenecteplase. Patients with minor stroke and intracranial occlusion should not be routinely treated with intravenous thrombolysis. FUNDING: Heart and Stroke Foundation of Canada, Canadian Institutes of Health Research, and the British Heart Foundation.

Plasma fibrinogen and risk of vascular recurrence after ischaemic stroke: An individual participant and summary-level data meta-analysis of 11 prospective studies.

INTRODUCTION: Inflammation is an emerging target for secondary prevention after stroke and randomised trials of anti-inflammatory therapies are ongoing. Fibrinogen, a putative pro-inflammatory marker, is associated with first stroke, but its association with major adverse cardiovascular events (MACE) after stroke is unclear. MATERIALS AND METHODS: We did a systematic review investigating the association between fibrinogen and post-stroke vascular recurrence. Authors were invited to provide individual-participant data (IPD) and where available we did within-study multivariable analyses with adjustment for cardiovascular risk factors and medications. Adjusted summary-level data was extracted from published reports from studies that did not provide IPD. We pooled risk ratios (RR) by random-effects meta-analysis by comparing supra-median with sub-median fibrinogen levels and performed pre-specified subgroup analysis according to timing of phlebotomy after the index event. RESULTS: Eleven studies were included (14,002 patients, 42,800 follow-up years), of which seven provided IPD. Fibrinogen was associated with recurrent MACE on unadjusted (RR 1.35, 95% CI 1.17-1.57, supra-median vs sub-median) and adjusted models (RR 1.21, 95% CI 1.06-1.38). Fibrinogen was associated with recurrent stroke on univariate analysis (RR 1.19, 95% CI 1.03-1.39), but not after adjustment (RR 1.11, 95% CI 0.94-1.31). The association with recurrent MACE was consistently observed in patients with post-acute (⩾14 days) fibrinogen measures (RR 1.29, 95% CI 1.16-1.45), but not in those with early phlebotomy (<14 days) (RR 0.98, 95% CI 0.82-1.18) (Pinteraction = 0.01). Similar associations were observed for recurrent stroke. DISCUSSION AND CONCLUSION: Fibrinogen was independently associated with recurrence after stroke, but the association was modified by timing of phlebotomy. Fibrinogen measurements might be useful to identify patients who are more likely to derive benefit from anti-inflammatory therapies after stroke.

An International, Multidisciplinary Consensus Set of Patient-Centered Outcome Measures for Substance-Related and Addictive Disorders.

Background: In 1990, the United States' Institute of Medicine promoted the principles of outcomes monitoring in the alcohol and other drugs treatment field to improve the evidence synthesis and quality of research. While various national outcome measures have been developed and employed, no global consensus on standard measurement has been agreed for addiction. It is thus timely to build an international consensus. Convened by the International Consortium for Health Outcomes Measurement (ICHOM), an international, multi-disciplinary working group reviewed the existing literature and reached consensus for a globally applicable minimum set of outcome measures for people who seek treatment for addiction. Methods: To this end, 26 addiction experts from 11 countries and 5 continents, including people with lived experience (n = 5; 19%), convened over 16 months (December 2018-March 2020) to develop recommendations for a minimum set of outcome measures. A structured, consensus-building, modified Delphi process was employed. Evidence-based proposals for the minimum set of measures were generated and discussed across eight videoconferences and in a subsequent structured online consultation. The resulting set was reviewed by 123 professionals and 34 people with lived experience internationally. Results: The final consensus-based recommendation includes alcohol, substance, and tobacco use disorders, as well as gambling and gaming disorders in people aged 12 years and older. Recommended outcome domains are frequency and quantity of addictive disorders, symptom burden, health-related quality of life, global functioning, psychosocial functioning, and overall physical and mental health and wellbeing. Standard case-mix (moderator) variables and measurement time points are also recommended. Conclusions: Use of consistent and meaningful outcome measurement facilitates carer-patient relations, shared decision-making, service improvement, benchmarking, and evidence synthesis for the evaluation of addiction treatment services and the dissemination of best practices. The consensus set of recommended outcomes is freely available for adoption in healthcare settings globally.

Statin Therapy for Secondary Prevention in Ischemic Stroke Patients With Cerebral Microbleeds.

BACKGROUND AND OBJECTIVES: The association between statin use and the risk of intracranial hemorrhage (ICrH) following ischemic stroke (IS) or transient ischemic attack (TIA) in patients with cerebral microbleeds (CMBs) remains uncertain. This study investigated the risk of recurrent IS and ICrH in patients receiving statins based on the presence of CMBs. METHODS: We conducted a pooled analysis of individual patient data from the Microbleeds International Collaborative Network, comprising 32 hospital-based prospective studies fulfilling the following criteria: adult patients with IS or TIA, availability of appropriate baseline MRI for CMB quantification and distribution, registration of statin use after the index stroke, and collection of stroke event data during a follow-up period of ≥3 months. The primary endpoint was the occurrence of recurrent symptomatic stroke (IS or ICrH), while secondary endpoints included IS alone or ICrH alone. We calculated incidence rates and performed Cox regression analyses adjusting for age, sex, hypertension, atrial fibrillation, previous stroke, and use of antiplatelet or anticoagulant drugs to explore the association between statin use and stroke events during follow-up in patients with CMBs. RESULTS: In total, 16,373 patients were included (mean age 70.5 ± 12.8 years; 42.5% female). Among them, 10,812 received statins at discharge, and 4,668 had 1 or more CMBs. The median follow-up duration was 1.34 years (interquartile range: 0.32-2.44). In patients with CMBs, statin users were compared with nonusers. Compared with nonusers, statin therapy was associated with a reduced risk of any stroke (incidence rate [IR] 53 vs 79 per 1,000 patient-years, adjusted hazard ratio [aHR] 0.68 [95% CI 0.56-0.84]), a reduced risk of IS (IR 39 vs 65 per 1,000 patient-years, aHR 0.65 [95% CI 0.51-0.82]), and no association with the risk of ICrH (IR 11 vs 16 per 1,000 patient-years, aHR 0.73 [95% CI 0.46-1.15]). The results in aHR remained consistent when considering anatomical distribution and high burden (≥5) of CMBs. DISCUSSION: These observational data suggest that secondary stroke prevention with statins in patients with IS or TIA and CMBs is associated with a lower risk of any stroke or IS without an increased risk of ICrH. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that for patients with IS or TIA and CMBs, statins lower the risk of any stroke or IS without increasing the risk of ICrH.

SMART Family and Friends: Feasibility and outcomes of a video-conference delivered intervention for families impacted by another's methamphetamine use.

INTRODUCTION: Families affected by another's substance use, including methamphetamine, experience harms to their mental and physical health. Yet, research has paid little attention to support and service needs of this population. This pilot study examines the feasibility and outcomes of SMART Family and Friends, a video-conference-delivered mutual-support group targeting families affected by another's methamphetamine use. METHODS: Recruitment for this study occurred between March-October 2021 via the SMART Recovery Australia website. Participants were English-speaking Australian residents, ≥18 years, affected by another's methamphetamine use, interested in participating in a manualised eight-module group delivered via video-conferencing. Feasibility was evaluated by attendance rates, participant satisfaction, fidelity ratings, and semi-structured interviews. Measures of distress, quality of life, and family functioning assessed outcomes at baseline and one-month post-treatment conclusion. RESULTS: Forty-three participants commenced SMART Family and Friends groups. 84 % (n = 36) completed ≥4 modules, 67 % (n = 29) completed ≥6, and 42 % (n = 18) completed all 8 modules. Participant satisfaction (M = 4.32, SD = 0.66, out of 5) and facilitator fidelity (>94 % for all modules) were high. A within-group analysis, without comparison condition demonstrated significant improvements in psychological distress (d = 0.38), family impact (d = 0.64), family strain symptoms (d = 0.48), and total family burden (d = 0.69) post-treatment. Qualitative findings illustrated the benefits and challenges of the video-conference-delivered group, as well as recommendations for improvement. CONCLUSIONS: Results provide initial support for the feasibility and positive outcomes of the SMART Family and Friends program. These findings demonstrate the successful provision of a mutual-support group for affected families delivered via video-conferencing, and merit further sufficiently powered randomised-control-trials to evaluate efficacy.

Cognitive remediation in residential substance use treatment: A randomized stepped-wedge trial.

ABSTRACTExecutive dysfunction is common in individuals with substance use disorder (SUD) and presents a barrier to treatment engagement. The study aimed to investigate the effectiveness of cognitive remediation (CR) for improving executive functioning and treatment retention in patients with SUD, using a stepped-wedge cluster randomized controlled trial. The sample included 527 adults enrolled across ten residential SUD treatment providers in NSW, Australia. The intervention consisted of 12 hours of CR delivered over six weeks in a group format. The comparator was treatment-as-usual (TAU). Primary outcomes included self-reported executive functioning and proportion of treatment completed (PoTC), measured as the number of days in treatment divided by the planned treatment duration. Intention-to-treat analysis did not find significant differences for self-reported executive functioning (mean difference = -2.49, 95%CI [-5.07, 0.09], p = .059) or PoTC (adjusted mean ratio = 1.09, 95%CI [0.88, 1.36], p = .442). Due to high dropout from the intention-to-treat sample (56%) a post-hoc analysis was conducted using a per-protocol approach, in which CR was associated with improved self-reported executive functioning (mean difference = -3.33, 95%CI [-6.10, -0.57], p = .019) and improved likelihood of treatment graduation (adjusted odds ratio = 2.43, 95%CI [1.43, 4.11], p < .001). More research is required to develop a CR approach that results in service-wide treatment effectiveness.

C-Reactive Protein, Interleukin-6, and Vascular Recurrence According to Stroke Subtype: An Individual Participant Data Meta-Analysis

BACKGROUND AND OBJECTIVES: Anti-inflammatory therapies reduce major adverse cardiovascular events (MACE) in coronary artery disease but remain unproven after stroke. Establishing the subtype-specific association between inflammatory markers and recurrence risk is essential for optimal selection of patients in randomized trials (RCTs) of anti-inflammatory therapies for secondary stroke prevention. METHODS: Using individual participant data (IPD) identified from a systematic review, we analyzed the association between high-sensitivity C-reactive protein, interleukin-6 (IL-6), and vascular recurrence after ischemic stroke or transient ischemic attack. The prespecified coprimary end points were (1) any recurrent MACE (first major coronary event, recurrent stroke, or vascular death) and (2) any recurrent stroke (ischemic, hemorrhagic, or unspecified) after sample measurement. Analyses were performed stratified by stroke mechanism, per quarter and per biomarker unit increase after loge transformation. We then did study-level meta-analysis with comparable published studies not providing IPD. Preferred Reporting Items for Systematic Review and Meta-Analyses IPD guidelines were followed. RESULTS: IPD was obtained from 10 studies (8,420 patients). After adjustment for vascular risk factors and statins/antithrombotic therapy, IL-6 was associated with recurrent MACE in stroke caused by large artery atherosclerosis (LAA) (risk ratio [RR] 2.30, 95% CI 1.21-4.36, p = 0.01), stroke of undetermined cause (UND) (RR 1.78, 1.19-2.66, p = 0.005), and small vessel occlusion (SVO) (RR 1.71, 0.99-2.96, p = 0.053) (quarter 4 [Q4] vs quarter 1 [Q1]). No association was observed for stroke due to cardioembolism or other determined cause. Similar results were seen for recurrent stroke and when analyzed per loge unit increase for MACE (LAA, RR 1.26 [1.06-1.50], p = 0.009; SVO, RR 1.22 [1.01-1.47], p = 0.04; UND, RR 1.18 [1.04-1.34], p = 0.01). High-sensitivity CRP was associated with recurrent MACE in UND stroke only (Q4 vs Q1 RR 1.45 [1.04-2.03], p = 0.03). Findings were consistent on study-level meta-analysis of the IPD results with 2 other comparable studies (20,136 patients). DISCUSSION: Our data provide new evidence for the selection of patients in future RCTs of anti-inflammatory therapy in stroke due to large artery atherosclerosis, small vessel occlusion, and undetermined etiology according to inflammatory marker profile.

Changes in anticoagulation practice in subjects admitted with stroke associated with atrial fibrillation, following introduction of direct oral anticoagulants over 2013-2021.

BACKGROUND: The adoption of direct oral anticoagulants (DOACs) has changed practice in prevention of stroke in atrial fibrillation (AF). We used Irish data national data on stroke and anticoagulation therapy over 9 years to investigate changes in anticoagulation practice and potential consequences on stroke prevalence and thrombolysis. METHODS: AF, anticoagulation, thrombolysis, and stroke data from the Irish National Audit of Stroke (INAS) 2013-2021 were reviewed. The proportion of patients with ischemic stroke (IS) and intracerebral hemorrhage (IH) with known AF admitted on anticoagulation was determined. Effects on age distribution in the population and thrombolysis practice were assessed. RESULTS: AF data were available on 34,630 of 35,241 individuals (98.3%) included in INAS; median age was 74 years and 56% were male. AF was found in 10,016 (28.9%, 9059 IS, 957 IH). 6313 had known AF prior to stroke (63.1%). The proportion all total IS due to AF decreased by 15.3% (31.3%-26.5%, chi-square = 24.6, p < 0.0001). The proportion of IH did not change significantly (21.6%-20.2%, chi-square = 1.8, p = 0.18). Over the 9 years, 3875 (38.6%) of the subjects with AF were recorded as receiving anticoagulants at admission. In 2013, 4.4% of AF-associated strokes were admitted on a DOAC and 21.4% on warfarin; by 2021, 44.1% were receiving a DOAC and 6.2% warfarin. There was a strong inverse correlation between the proportion of anticoagulated stroke patients and the total proportion of AF-associated strokes over time (r = -0.82, p = 0.006). In contrast, no correlation was found between increasing DOAC usage and IH (r = 0.14, p = 0.71). Increased anticoagulation usage correlated with a reduction in patients ⩾ 80 years (r = -0.83, p = 0.006) and also correlated with a relative reduction of 30.1% in subjects thrombolysed <4 h from onset (r = -0.89, p = 0.001). CONCLUSION: DOACs have led to increased use of anticoagulation, but warfarin use fell by two-thirds. There has been a reduction in the proportion of AF-associated IS without a noticeable increase in IH. Increased anticoagulation correlated with reduced numbers of strokes in those >80 years and in the proportion of patients thrombolysed.

'Quitlink': Outcomes of a randomised controlled trial of peer researcher facilitated referral to a tailored quitline tobacco treatment for people receiving mental health services.

OBJECTIVE: The aim of this study was to test the effectiveness of a tailored quitline tobacco treatment ('Quitlink') among people receiving support for mental health conditions. METHODS: We employed a prospective, cluster-randomised, open, blinded endpoint design to compare a control condition to our 'Quitlink' intervention. Both conditions received a brief intervention delivered by a peer researcher. Control participants received no further intervention. Quitlink participants were referred to a tailored 8-week quitline intervention delivered by dedicated Quitline counsellors plus combination nicotine replacement therapy. The primary outcome was self-reported 6 months continuous abstinence from end of treatment (8 months from baseline). Secondary outcomes included additional smoking outcomes, mental health symptoms, substance use and quality of life. A within-trial economic evaluation was conducted. RESULTS: In total, 110 participants were recruited over 26 months and 91 had confirmed outcomes at 8 months post baseline. There was a difference in self-reported prolonged abstinence at 8-month follow-up between Quitlink (16%, n = 6) and control (2%, n = 1) conditions, which was not statistically significant (OR = 8.33 [0.52, 132.09] p = 0.131 available case). There was a significant difference in favour of the Quitlink condition on 7-day point prevalence at 2 months (OR = 8.06 [1.27, 51.00] p = 0.027 available case). Quitlink costs AU$9231 per additional quit achieved. CONCLUSION: The Quitlink intervention did not result in significantly higher rates of prolonged abstinence at 8 months post baseline. However, engagement rates and satisfaction with the 'Quitlink' intervention were high. While underpowered, the Quitlink intervention shows promise. A powered trial to determine its effectiveness for improving long-term cessation is warranted.

Targeting inflammation to reduce recurrent stroke.

BACKGROUND: Approximately one in four stroke patients suffer from recurrent vascular events, underlying the necessity to improve secondary stroke prevention strategies. Immune mechanisms are causally associated with coronary atherosclerosis. However, stroke is a heterogeneous disease and the relative contribution of inflammation across stroke mechanisms is not well understood. The optimal design of future randomized control trials (RCTs) of anti-inflammatory therapies to prevent recurrence after stroke must be informed by a clear understanding of the prognostic role of inflammation according to stroke subtype and individual patient factors. AIM: In this narrative review, we discuss (1) inflammatory pathways in the etiology of ischemic stroke subtypes; (2) the evidence on inflammatory markers and vascular recurrence after stroke; and (3) review RCT evidence of anti-inflammatory agents for vascular prevention. SUMMARY OF REVIEW: Experimental work, genetic epidemiological data, and plaque-imaging studies all implicate inflammation in atherosclerotic stroke. However, emerging evidence also suggests that inflammatory mechanisms are also important in other stroke mechanisms. Advanced neuroimaging techniques support the role of neuroinflammation in blood-brain barrier dysfunction in cerebral small vessel disease (cSVD). Systemic inflammatory processes also promote atrial cardiopathy, incident and recurrent atrial fibrillation (AF). Although several inflammatory markers have been associated with recurrence after stroke, interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hsCRP) are presently the most promising markers to identify patients at increased vascular risk. Several RCTs have shown that anti-inflammatory therapies reduce vascular risk, including stroke, in coronary artery disease (CAD). Some, but not all of these trials, selected patients on the basis of elevated hsCRP. Although unproven after stroke, targeting inflammation to reduce recurrence is a compelling strategy and several RCTs are ongoing. CONCLUSION: Evidence points toward the importance of inflammation across multiple stroke etiologies and potential benefit of anti-inflammatory targets in secondary stroke prevention. Taking the heterogeneous stroke etiologies into account, the use of serum biomarkers could be useful to identify patients with residual inflammatory risk and perform biomarker-led patient selection for future RCTs.