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Abstract This updated systematic review assesses the effects of pharmacological interventions for drug-using offenders. Methods Systematic review protocols and conventions of the Cochrane Collaboration were followed to identify eligible studies. Studies were pooled in a meta-analysis to assess the impact of pharmacological interventions on drug use and criminal activity. An economic appraisal was conducted. Results The search strategies identified 22 studies containing 4372 participants. Meta-analyses revealed a small statistically significant mean difference favouring pharmacological interventions relative to psychological interventions in reducing drug use and criminal activity. When comparing the drugs to one another there were no significant differences between those included (methadone versus buprenorphine, naltrexone and cyclazocine). Conclusion Overall, the findings of this review suggest that methadone and naltrexone may have some impact on reducing drug use and reincarceration. Individual pharmacological drugs had differing (generally non-significant) effects. One study identified serious adverse events. Three studies reported cost and consequences information sufficient to conduct a full economic analysis but this was not comprehensive enough to be able to make judgements across all treatment options. Full economic analyses should be encouraged. The study findings were limited mainly to male adult offenders.

4090 Background: BTC is associated with poor prognosis and limited treatment choices. There is limited evidence on HCRU and costs among BTC patients receiving systemic treatments (ST). This study examined HCRU and total direct cost of care among BTC patients treated with ST to understand the disease burden in management of BTC. Methods: A retrospective cohort study of BTC patients who received first line (1L) ST was conducted, using US private payer Cancer Care Quality Program data and administrative claims from the HealthCore Integrated Research Database between 07/01/2014 - 03/31/2021. Patients with ampullary cancer, brain/ CNS metastases, other primary cancer before BTC diagnosis were excluded. Per patient per month (PPPM) costs in 2020 USD were calculated during 1L, 2L, and 3L treatments associated with HCRU from inpatient, emergency room, and outpatient visits as well as outpatient pharmacy dispensing. Results: Among 298 BTC patients (biliary tract, n=203; gallbladder, n=65; bile duct, n=30; stage IV, n=231; stage III, n=28; stage I/II, n=39) who received ST, mean (SD) age was 61.7 (9) years at 1L treatment initiation, and the majority were female (58%). Following 1L treatment, 44% received 2L treatment, and 16% received 3L treatment. Median follow-up was 7.6 months. Among 201 (67%) patients who had hospitalization in the follow-up period, mean (SD) number of hospitalizations was 2.5 (2), and the average length of stay was 7.0 (5) days. Total PPPM all-cause costs were the lowest during 1L treatment (mean [SD]: $19,589 [$22,603]), and increased as the treatment advanced (2L: $22,617[$19,302]; 3L: $33,534[$40,588]). Similar trend was observed in BTC-related total costs with $16,237 ($22,452) in 1L, $19,083 ($18,670) in 2L and $27,609 ($39,949) in 3L. The table summarizes BTC-related HCRU and PPPM cost during each line of therapy. Conclusions: Study findings suggest significant resource use burden and high total direct medical costs for BTC patients receiving ST. Hospitalizations and outpatient visits represent important HCRU and cost for BTC. These data indicate a need for future newer innovative therapies in the management of BTC.[Table: see text]

Background\ud \ud This review represents one from a family of three reviews focusing on interventions for drug‐using offenders. Many people under the care of the criminal justice system have co‐occurring mental health problems and drug misuse problems; it is important to identify the most effective treatments for this vulnerable population.\ud \ud \ud \ud Objectives\ud \ud To assess the effectiveness of interventions for drug‐using offenders with co‐occurring mental health problems in reducing criminal activity or drug use, or both.\ud \ud \ud \ud This review addresses the following questions.\ud \ud \ud \ud • Does any treatment for drug‐using offenders with co‐occurring mental health problems reduce drug use?\ud \ud \ud \ud • Does any treatment for drug‐using offenders with co‐occurring mental health problems reduce criminal activity?\ud \ud \ud \ud • Does the treatment setting (court, community, prison/secure establishment) affect intervention outcome(s)?\ud \ud \ud \ud • Does the type of treatment affect treatment outcome(s)?\ud \ud \ud \ud Search methods\ud \ud We searched 12 databases up to February 2019 and checked the reference lists of included studies. We contacted experts in the field for further information.\ud \ud \ud \ud Selection criteria\ud \ud We included randomised controlled trials designed to prevent relapse of drug use and/or criminal activity among drug‐using offenders with co‐occurring mental health problems.\ud \ud \ud \ud Data collection and analysis\ud \ud We used standard methodological procedures as expected by Cochrane .\ud \ud \ud \ud Main results\ud \ud We included 13 studies with a total of 2606 participants. Interventions were delivered in prison (eight studies; 61%), in court (two studies; 15%), in the community (two studies; 15%), or at a medium secure hospital (one study; 8%). Main sources of bias were unclear risk of selection bias and high risk of detection bias.\ud \ud \ud \ud Four studies compared a therapeutic community intervention versus (1) treatment as usual (two studies; 266 participants), providing moderate‐certainty evidence that participants who received the intervention were less likely to be involved in subsequent criminal activity (risk ratio (RR) 0.67, 95% confidence interval (CI) 0.53 to 0.84) or returned to prison (RR 0.40, 95% CI 0.24 to 0.67); (2) a cognitive‐behavioural therapy (one study; 314 participants), reporting no significant reduction in self‐reported drug use (RR 0.78, 95% CI 0.46 to 1.32), re‐arrest for any type of crime (RR 0.69, 95% CI 0.44 to 1.09), criminal activity (RR 0.74, 95% CI 0.52 to 1.05), or drug‐related crime (RR 0.87, 95% CI 0.56 to 1.36), yielding low‐certainty evidence; and (3) a waiting list control (one study; 478 participants), showing a significant reduction in return to prison for those people engaging in the therapeutic community (RR 0.60, 95% CI 0.46 to 0.79), providing moderate‐certainty evidence.\ud \ud \ud \ud One study (235 participants) compared a mental health treatment court with an assertive case management model versus treatment as usual, showing no significant reduction at 12 months' follow‐up on an Addictive Severity Index (ASI) self‐report of drug use (mean difference (MD) 0.00, 95% CI ‐0.03 to 0.03), conviction for a new crime (RR 1.05, 95% CI 0.90 to 1.22), or re‐incarceration to jail (RR 0.79, 95% CI 0.62 to 1.01), providing low‐certainty evidence.\ud \ud \ud \ud Four studies compared motivational interviewing/mindfulness and cognitive skills with relaxation therapy (one study), a waiting list control (one study), or treatment as usual (two studies). In comparison to relaxation training, one study reported narrative information on marijuana use at three‐month follow‐up assessment. Researchers reported a main effect < .007 with participants in the motivational interviewing group, showing fewer problems than participants in the relaxation training group, with moderate‐certainty evidence. In comparison to a waiting list control, one study reported no significant reduction in self‐reported drug use based on the ASI (MD ‐0.04, 95% CI ‐0.37 to 0.29) and on abstinence from drug use (RR 2.89, 95% CI 0.73 to 11.43), presenting low‐certainty evidence at six months (31 participants). In comparison to treatment as usual, two studies (with 40 participants) found no significant reduction in frequency of marijuana use at three months post release (MD ‐1.05, 95% CI ‐2.39 to 0.29) nor time to first arrest (MD 0.87, 95% CI ‐0.12 to 1.86), along with a small reduction in frequency of re‐arrest (MD ‐0.66, 95% CI ‐1.31 to ‐0.01) up to 36 months, yielding low‐certainty evidence; the other study with 80 participants found no significant reduction in positive drug screens at 12 months (MD ‐0.7, 95% CI ‐3.5 to 2.1), providing very low‐certainty evidence.\ud \ud \ud \ud Two studies reported on the use of multi‐systemic therapy involving juveniles and families versus treatment as usual and adolescent substance abuse therapy. In comparing treatment as usual, researchers found no significant reduction up to seven months in drug dependence on the Drug Use Disorders Identification Test (DUDIT) score (MD ‐0.22, 95% CI ‐2.51 to 2.07) nor in arrests (RR 0.97, 95% CI 0.70 to 1.36), providing low‐certainty evidence (156 participants). In comparison to an adolescent substance abuse therapy, one study (112 participants) found significant reduction in re‐arrests up to 24 months (MD 0.24, 95% CI 0.76 to 0.28), based on low‐certainty evidence.\ud \ud \ud \ud One study (38 participants) reported on the use of interpersonal psychotherapy in comparison to a psychoeducational intervention. Investigators found no significant reduction in self‐reported drug use at three months (RR 0.67, 95% CI 0.30 to 1.50), providing very low‐certainty evidence. The final study (29 participants) compared legal defence service and wrap‐around social work services versus legal defence service only and found no significant reductions in the number of new offences committed at 12 months (RR 0.64, 95% CI 0.07 to 6.01), yielding very low‐certainty evidence.\ud \ud \ud \ud Authors' conclusions\ud \ud Therapeutic community interventions and mental health treatment courts may help people to reduce subsequent drug use and/or criminal activity. For other interventions such as interpersonal psychotherapy, multi‐systemic therapy, legal defence wrap‐around services, and motivational interviewing, the evidence is more uncertain. Studies showed a high degree of variation, warranting a degree of caution in interpreting the magnitude of effect and the direction of benefit for treatment outcomes.

The SPIRIT 2013 Checklist: MCLASS II trial protocol*. (DOC 121 kb)

India is a diverse land with different cultures, social norms, castes, religions, faiths, languages, politics, and a complex healthcare system. As a step to enhance healthcare, the government of India announced a move toward universal health coverage to increase accessibility and affordability of health-related services. Recently, there has been an introduction of health technology assessment (HTA) in India to help inform evidence-based decision making in cases of limited resources and budgets. Nevertheless, there are challenges related to biased decision making, an unregulated healthcare framework, and the lack of data and capacity that will (directly or indirectly) affect the use of HTA in India. For HTA to be successful in India and in similar low- and middle-income countries, it is important that the decision makers acknowledge these challenges and embrace differences in ideologies, cultures, and politics instead of ignoring them. Drawing lessons from countries with well-developed HTA bodies may help, but these need to be modified for the country-specific context. Ensuring quality and transparency is key to building trust in medical decision making. Improved coordination at all levels of healthcare is vital to ensure the long-term success of HTA in India. This is challenging but achievable by spreading awareness among stakeholders and achieving moderate health-sector regulation that can combat corruption. HTA will prosper in India if it incorporates cultural and institutional diversity, alongside tackling socioeconomic inequalities.

INTRODUCTION: Tobacco smoking among tuberculosis (TB) patients leads to poorer treatment outcomes. Smoking cessation support should be integrated into routine TB care. We measured healthcare providers' fidelity to a smoking cessation intervention integrated into routine TB care, in Bangladesh and Pakistan. We aimed to understand the role of providers and settings in the implementation of behavior support (BS) messages for TB and smoking cessation.METHODS: The integrated BS intervention was implemented in TB clinics (24 public and 1 private). Cross-sectional data were collected on the fidelity of delivery of the BS intervention using a predefined fidelity index based on an existing validated method of measuring intervention fidelity. Audio-recordings of patient-provider BS sessions were coded using the fidelity index. Intervention fidelity was presented as the proportion of sessions that implemented BS messages.RESULTS: A total of 96 sessions were conducted, 37 in Bangladesh and 59 in Pakistan. In public settings, TB medication advice was offered in 91.9% (95% CI: 78.7- 97.2) of sessions in Bangladesh, and in 75.5% (95% CI: 62.4-85.1) of sessions in Pakistan; whilst it was offered in 83.3% (95% CI: 43.7-97.0) of sessions in the private setting in Pakistan. Patients' smoking status was assessed in 70.3% (95% CI: 54.2-82.5) of sessions in Bangladesh, and in 34.0% (95% CI: 22.7-47.4) of sessions in the public setting and in 66.7% (95% CI: 30.0-90.3) of sessions in the private setting in Pakistan. A quit date was set in 32.4% (95% CI: 19.6-48.5) of all sessions in Bangladesh, and in 33.3% (95% CI: 9.6-70.0) of all sessions in the public setting in Pakistan.CONCLUSIONS: Fidelity to the intended delivery of the intervention was found to be high for TB-related messages but not for smoking cessation messages. Clinic contexts may play a mediating role in health workers' opportunities to deliver the intervention as planned.TRIAL REGISTRATION: International Standard Randomized Clinical Trial Number (ISRCTN43811467). Registered 23 March 2016, https://doi.org/10.1186/ISRCTN43811467.