Real-World Effectiveness in Hypertension and Hyperlipidemia Collaborative Management between Pharmacies and Primary Care in Portugal: A Multicenter Pragmatic Controlled Trial (USFarmácia®).

There is evidence of the efficacy of collaborative health interventions with pharmacies and primary care providers but little of its real-world effectiveness. We aimed to assess the effectiveness and discuss the design and challenges of hypertension and hyperlipidemia management between pharmacies and primary care providers using real-world data exchange between providers and experimental bundled payment. This was a pragmatic, quasi-experimental controlled trial. We collected patient-level data from primary care prescription claims and Electronic Medical Record databases, a pharmacy claims database, and patient telephone surveys at several time points. The primary outcomes were changes in blood pressure and total cholesterol. We used matched controls with difference-in-differences estimators in a Generalized Linear Model (GLM) and controlled interrupted time series (CITS). We collected additional data for economic and qualitative studies. A total of 6 Primary Care Units, 20 pharmacies, and 203 patients entered the study. We were not able to observe significant differences in the effect of intervention vs. control. We experienced challenges that required creative strategies. This real-world trial was not able to show effectiveness, likely due to limitations in the primary care technology which affected the sample size. It offers, however, valuable lessons on methods, strategies, and data sources, paving the way for more real-world effectiveness trials to advance value-based healthcare.

Effectiveness of a collaborative diabetes screening campaign between community pharmacies and general practitioners.

AIM: To evaluate the impact of a collaborative screening campaign on the prevalence of pre-diabetes and diabetes among the screened population. METHODS: A Longitudinal, multicentre study was developed. The Finnish Diabetes Risk Score (FINDRISC) was applied to the eligible population in the participating community pharmacies. Individuals with a FINDRISC score ≥ 15, were eligible to measure their glycated haemoglobin (HbA1c) level at the community pharmacy. If HbA1c≥ 5.7%, participants were referred to a general practitioner (GP) appointment for potential diagnosis of Diabetes. RESULTS: Out of 909 screened subjects, 405 (44.6%) presented a FINDRISC score ≥ 15. Among the latter, 94 (23.4%) had HbA1c levels that made them eligible for GP referral, of which 35 (37.2%) completed the scheduled appointments. 24 participants were diagnosed with pre-diabetes, and 11 with diabetes. The prevalence was estimated at 2.5% (CI95% 1.6-3.8%) and 7.8% (CI95% 6.2-9.8%) for diabetes and pre-diabetes, respectively. CONCLUSION: This collaborative model has proved to be effective in the early detection of diabetes and pre-diabetes. Joint initiatives between health professionals can play a pivotal role in the prevention and diagnosis of diabetes, which may lead to a reduction on the burden to health system and society.

Costs and consequences of the Portuguese needle-exchange program in community pharmacies.

BACKGROUND: Needle-exchange programs (NEPs) reduce infections in people who inject drugs. This study assesses the impact community pharmacies have had in the Needle-Exchange Program in Portugal since 2015. METHODS: Health gains were measured by the number of human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infections averted, which were estimated, in each scenario, based on a standard model in the literature, calibrated to national data. The costs per infection were taken from national literature; costs of manufacturing, logistics and incineration of injection materials were also considered. The results were presented as net costs (i.e., incremental costs of the program with community pharmacies less the costs of additional infections avoided). RESULTS: Considering a 5-year horizon, the Needle Exchange Program with community pharmacies would account for a 6.8% (n = 25) and a 6.5% reduction (n = 22) of HCV and HIV infections, respectively. The present value of net savings generated by the participation of community pharmacies in the program was estimated at €2,073,347. The average discounted net benefit per syringe exchanged is €3.01, already taking into account a payment to community pharmacies per needle exchanged. INTERPRETATION: We estimate that the participation of community pharmacies in the Needle Exchange Program will lead to a reduction of HIV and HCV infections and will generate over €2 million in savings for the health system. CONCLUSIONS: The intervention is estimated to generate better health outcomes at lower costs, contributing to improving the efficiency of the public health system in Portugal.

Quality and risk of bias appraisals of systematic reviews are inconsistent across reviewers and centers.

OBJECTIVE: The objective of the study was to evaluate the inter-rater and intercenter reliability, usability, and utility of A MeaSurement Tool to Assess systematic Reviews (AMSTAR), AMSTAR 2, and Risk Of Bias In Systematic reviews (ROBIS). STUDY DESIGN AND SETTING: This is a prospective evaluation using 30 systematic reviews of randomized trials, undertaken at three international centers. RESULTS: Reviewers completed AMSTAR, AMSTAR 2, and ROBIS in median (interquartile range) 15.7 (11.3), 19.7 (12.1), and 28.7 (17.4) minutes and reached consensus in 2.6 (3.2), 4.6 (5.3), and 10.9 (10.8) minutes, respectively. Across all centers, inter-rater reliability was substantial to almost perfect for 8/11 AMSTAR, 9/16 AMSTAR 2, and 12/24 ROBIS items. Intercenter reliability was substantial to almost perfect for 6/11 AMSTAR, 12/16 AMSTAR 2, and 7/24 ROBIS items. Intercenter reliability for confidence in the results of the review or overall risk of bias was moderate (Gwet's first-order agreement coefficient (AC1) 0.58, 95% confidence intervals [CI]: 0.30 to 0.85) to substantial (AC1 0.74, 95% CI: 0.30 to 0.85) for AMSTAR 2 and poor (AC1 -0.21, 95% CI: -0.55 to 0.13) to moderate (AC1 0.56, 95% CI: 0.30 to 0.83) for ROBIS. It is not clear whether using the appraisals of any tool as an inclusion criterion would alter an overview's findings. CONCLUSIONS: Improved guidance may be needed to facilitate the consistent interpretation and application of the newer tools (especially ROBIS).

An overview of systematic reviews of economic evaluations of pharmacy-based public health interventions: addressing methodological challenges.

BACKGROUND: Pharmacy interventions are a subset of public health interventions and its research is usually performed within the scope of a trial. The economic evaluation of pharmacy interventions requires certain considerations which have some similarities to those of public health interventions and to economic evaluations alongside trials. The objective of this research is to perform an overview of systematic reviews of economic evaluations of pharmacy services and triangulate results with recommendations for economic evaluations of both public health interventions and alongside trials. METHODS: (1) Exploratory review of recommendations on the economic evaluation of public health interventions, (2) exploratory review of recommendations for conducting economic evaluations alongside trials, (3) overview of systematic reviews of economic evaluations of pharmacy interventions (protocol registered with PROSPERO 2016 outlining information sources, inclusion criteria, appraisal of reviews and synthesis methods). RESULTS: Fourteen systematic reviews containing 75 index publications were included. Reviews reported favorable economic findings for 71% of studies with full economic evaluations. The types of economic analysis are diverse. Two critical quality domains are absent from most reviews. Key findings include the following: certain types of risk of bias, wider scope of study designs, and most economic quality criteria met but some issues unresolved or unclear. Triangulation revealed additional gaps. Limitations include choice of critical quality domains and potential biases in the overview process. CONCLUSIONS: Economic evaluations of pharmacy-based public health interventions seem to follow most economic quality criteria, but there are still some issues in certain key areas to improve. These findings may assist in improving the design of pilot trials of economic evaluations in pharmacy, leading to robust evidence for payers. Based on the findings, we propose a methodological approach for the economic evaluation of pharmacy-based public health interventions. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016032768.

Intensive Monitoring Studies for Assessing Medicines: A Systematic Review.

Introduction: Intensive monitoring (IM) is one of the methods of post-marketing active surveillance based upon event monitoring, which has received interest in the current medicines regulatory landscape. For a specific period of time, IM involves primary data collection and is actively focused on gathering longitudinal information, mainly safety, since the first day of drug use. Objectives: To describe IM systems and studies' data published over 11-years period (2006-2016). Specifically, we reviewed study population/event surveillance, methodological approaches, limitations, and its applications in the real-world evidence generation data. Methods: We completed a systematic search of MEDLINE and EMBASE to identify studies published from 2006 to 2016, that used IM methodology. We extracted data using a standardized form and results were analyzed descriptively. The methodological quality of selected studies was assessed using the modified Downs and Black checklist. Results: From 1,400 screened citations, we identified 86 papers, corresponding to 69 different studies. Seventy percent of reviewed studies corresponded to established IM systems, of which, more than half were prescription event monitoring (PEM) and modified-PEM. Among non-established IM systems, vaccines were the most common studied drugs (n = 14). The median cohort size ranged from 488 (hospitals) to 10,479 (PEM) patients. Patients and caregivers were the event data source in 39.1% of studies. The mean overall quality score was similar between established and non-established IM. Conclusions: Over the study period, IM studies were implemented in 26 countries with different maturity levels of post-marketing surveillance systems. We identified two major limitations: only 20% of studies were conducted at hospital-level, which is a matter of concern, insofar as healthcare systems are facing a lack of access to new medicines at ambulatory care level. Additionally, IM access to data of drug exposure cohorts, either at identification or at follow-up stages, could somehow constitute a barrier, given the complexity of managerial, linkable, and privacy data issues.

Diabetes policies and pharmacy-based diabetes interventions in Portugal: a comprehensive review.

BACKGROUND: Pharmacy-based interventions are complex public health endeavors which include, but are not restricted to, the conventional medication supply role. In diabetes, such interventions may improve patients' outcomes. The aim of this study was to review relevant policies and research developed in Portugal directed at pharmacy-based diabetes interventions, and to inform future policies, practice and research in collaborative practice with primary care. RESEARCH METHOD: An exploratory review of diabetes legislation and policy papers, as well as a comprehensive review in Embase, MEDLINE (via Ovid and PubMed), Google Scholar, and grey literature until November 2017 was performed. RESULTS: Sixteen policy papers and 10 studies were included in the analysis. Positive evidence from pharmacy interventions was retrieved concerning screening individuals at risk, screening uncontrolled patients, managing diabetes, and supporting self-monitoring. CONCLUSIONS: Some consistency in favorable findings, but also room for improvements in health policies, intervention design and research methods, were observed.

Evaluation of the reliability, usability, and applicability of AMSTAR, AMSTAR 2, and ROBIS: protocol for a descriptive analytic study.

BACKGROUND: Systematic reviews (SRs) of randomised controlled trials (RCTs) can provide the best evidence to inform decision-making, but their methodological and reporting quality varies. Tools exist to guide the critical appraisal of quality and risk of bias in SRs, but evaluations of their measurement properties are limited. We will investigate the interrater reliability (IRR), usability, and applicability of A MeaSurement Tool to Assess systematic Reviews (AMSTAR), AMSTAR 2, and Risk Of Bias In Systematic reviews (ROBIS) for SRs in the fields of biomedicine and public health. METHODS: An international team of researchers at three collaborating centres will undertake the study. We will use a random sample of 30 SRs of RCTs investigating therapeutic interventions indexed in MEDLINE in February 2014. Two reviewers at each centre will appraise the quality and risk of bias in each SR using AMSTAR, AMSTAR 2, and ROBIS. We will record the time to complete each assessment and for the two reviewers to reach consensus for each SR. We will extract the descriptive characteristics of each SR, the included studies, participants, interventions, and comparators. We will also extract the direction and strength of the results and conclusions for the primary outcome. We will summarise the descriptive characteristics of the SRs using means and standard deviations, or frequencies and proportions. To test for interrater reliability between reviewers and between the consensus agreements of reviewer pairs, we will use Gwet's AC1 statistic. For comparability to previous evaluations, we will also calculate weighted Cohen's kappa and Fleiss' kappa statistics. To estimate usability, we will calculate the mean time to complete the appraisal and to reach consensus for each tool. To inform applications of the tools, we will test for statistical associations between quality scores and risk of bias judgments, and the results and conclusions of the SRs. DISCUSSION: Appraising the methodological and reporting quality of SRs is necessary to determine the trustworthiness of their conclusions. Which tool may be most reliably applied and how the appraisals should be used is uncertain; the usability of newly developed tools is unknown. This investigation of common (AMSTAR) and newly developed (AMSTAR 2, ROBIS) tools will provide empiric data to inform their application, interpretation, and refinement.

Social and economic value of Portuguese community pharmacies in health care.

BACKGROUND: Community pharmacies are major contributors to health care systems across the world. Several studies have been conducted to evaluate community pharmacies services in health care. The purpose of this study was to estimate the social and economic benefits of current and potential future community pharmacies services provided by pharmacists in health care in Portugal. METHODS: The social and economic value of community pharmacies services was estimated through a decision-model. Model inputs included effectiveness data, quality of life (QoL) and health resource consumption, obtained though literature review and adapted to Portuguese reality by an expert panel. The estimated economic value was the result of non-remunerated pharmaceutical services plus health resource consumption potentially avoided. Social and economic value of community pharmacies services derives from the comparison of two scenarios: "with service" versus "without service". RESULTS: It is estimated that current community pharmacies services in Portugal provide a gain in QoL of 8.3% and an economic value of 879.6 million euros (M€), including 342.1 M€ in non-remunerated pharmaceutical services and 448.1 M€ in avoided expense with health resource consumption. Potential future community pharmacies services may provide an additional increase of 6.9% in QoL and be associated with an economic value of 144.8 M€: 120.3 M€ in non-remunerated services and 24.5 M€ in potential savings with health resource consumption. CONCLUSIONS: Community pharmacies services provide considerable benefit in QoL and economic value. An increase range of services including a greater integration in primary and secondary care, among other transversal services, may add further social and economic value to the society.

Effectiveness of needle and syringe Programmes in people who inject drugs - An overview of systematic reviews.

BACKGROUND: Needle and syringe programmes (NSP) are a critical component of harm reduction interventions among people who inject drugs (PWID). Our primary objective was to summarize the evidence on the effectiveness of NSP for PWID in reducing blood-borne infection transmission and injecting risk behaviours (IRB). METHODS: We conducted an overview of systematic reviews that included PWID (excluding prisons and consumption rooms), addressed community-based NSP, and provided estimates of the effect regarding incidence/prevalence of Human Immunodeficiency Virus (HIV), Hepatitis C virus (HCV), Hepatitis B virus (HBV) and bacteremia/sepsis, and/or measures of IRB. Systematic literature searches were undertaken on relevant databases, including EMBASE, MEDLINE, and PsychINFO (up to May 2015). For each review we identified relevant studies and extracted data on methods, and findings, including risk of bias and quality of evidence assessed by review authors. We evaluated the risk of bias of each systematic review using the ROBIS tool. We categorized reviews by reported outcomes and use of meta-analysis; no additional statistical analysis was performed. RESULTS: We included thirteen systematic reviews with 133 relevant unique studies published between 1989 and 2012. Reported outcomes related to HIV (n = 9), HCV (n = 8) and IRB (n = 6). Methods used varied at all levels of design and conduct, with four reviews performing meta-analysis. Only two reviews were considered to have low risk of bias using the ROBIS tool, and most included studies were evaluated as having low methodological quality by review authors. We found that NSP was effective in reducing HIV transmission and IRB among PWID, while there were mixed results regarding a reduction of HCV infection. Full harm reduction interventions provided at structural level and in multi-component programmes, as well as high level of coverage, were more beneficial. CONCLUSIONS: The heterogeneity and the overall low quality of evidence highlights the need for future community-level studies of adequate design to support these results. TRIAL REGISTRATION: The protocol of this systematic review was registered in Prospective Register of Systematic Reviews (PROSPERO 2015: CRD42015026145 ).

The effectiveness, acceptability and cost-effectiveness of psychosocial interventions for maltreated children and adolescents: an evidence synthesis.

BACKGROUND: Child maltreatment is a substantial social problem that affects large numbers of children and young people in the UK, resulting in a range of significant short- and long-term psychosocial problems. OBJECTIVES: To synthesise evidence of the effectiveness, cost-effectiveness and acceptability of interventions addressing the adverse consequences of child maltreatment. STUDY DESIGN: For effectiveness, we included any controlled study. Other study designs were considered for economic decision modelling. For acceptability, we included any study that asked participants for their views. PARTICIPANTS: Children and young people up to 24 years 11 months, who had experienced maltreatment before the age of 17 years 11 months. INTERVENTIONS: Any psychosocial intervention provided in any setting aiming to address the consequences of maltreatment. MAIN OUTCOME MEASURES: Psychological distress [particularly post-traumatic stress disorder (PTSD), depression and anxiety, and self-harm], behaviour, social functioning, quality of life and acceptability. METHODS: Young Persons and Professional Advisory Groups guided the project, which was conducted in accordance with Cochrane Collaboration and NHS Centre for Reviews and Dissemination guidance. Departures from the published protocol were recorded and explained. Meta-analyses and cost-effectiveness analyses of available data were undertaken where possible. RESULTS: We identified 198 effectiveness studies (including 62 randomised trials); six economic evaluations (five using trial data and one decision-analytic model); and 73 studies investigating treatment acceptability. Pooled data on cognitive-behavioural therapy (CBT) for sexual abuse suggested post-treatment reductions in PTSD [standardised mean difference (SMD) -0.44 (95% CI -4.43 to -1.53)], depression [mean difference -2.83 (95% CI -4.53 to -1.13)] and anxiety [SMD -0.23 (95% CI -0.03 to -0.42)]. No differences were observed for post-treatment sexualised behaviour, externalising behaviour, behaviour management skills of parents, or parental support to the child. Findings from attachment-focused interventions suggested improvements in secure attachment [odds ratio 0.14 (95% CI 0.03 to 0.70)] and reductions in disorganised behaviour [SMD 0.23 (95% CI 0.13 to 0.42)], but no differences in avoidant attachment or externalising behaviour. Few studies addressed the role of caregivers, or the impact of the therapist-child relationship. Economic evaluations suffered methodological limitations and provided conflicting results. As a result, decision-analytic modelling was not possible, but cost-effectiveness analysis using effectiveness data from meta-analyses was undertaken for the most promising intervention: CBT for sexual abuse. Analyses of the cost-effectiveness of CBT were limited by the lack of cost data beyond the cost of CBT itself. CONCLUSIONS: It is not possible to draw firm conclusions about which interventions are effective for children with different maltreatment profiles, which are of no benefit or are harmful, and which factors encourage people to seek therapy, accept the offer of therapy and actively engage with therapy. Little is known about the cost-effectiveness of alternative interventions. LIMITATIONS: Studies were largely conducted outside the UK. The heterogeneity of outcomes and measures seriously impacted on the ability to conduct meta-analyses. FUTURE WORK: Studies are needed that assess the effectiveness of interventions within a UK context, which address the wider effects of maltreatment, as well as specific clinical outcomes. STUDY REGISTRATION: This study is registered as PROSPERO CRD42013003889. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Human trafficking and severe mental illness: an economic analysis of survivors' use of psychiatric services.

BACKGROUND: Previous studies have found a high prevalence of depression and post-traumatic stress disorder (PTSD) among survivors of human trafficking. European countries are required to assist trafficked people in their psychological recovery, but there are no rigorous data on the costs of doing so. The objectives of this study were to quantify the use of secondary mental health services by survivors of human trafficking; to estimate the cost of survivors' use of secondary mental health services provided by the UK National Health Service (NHS); and to identify factors that predict higher costs of mental health service provision. METHODS: Historical cohort study of psychiatric patients who had experienced human trafficking. The South London and Maudsley NHS Trust (SLaM) Biomedical Research Centre Case Register Interactive Search (CRIS) database was used to identify anonymised full patient records of patients who had experienced human trafficking and who had accessed SLaM mental health services between 2007 and 2012. Data were extracted on socio-demographic and trafficking characteristics and contacts with mental health services. Total costs were calculated by multiplying each resource use item by an appropriate unit cost. Factors that predicted high mental health service costs were analysed using regression models. RESULTS: One hundred nineteen patients were included in the analysis. Mean total mental health service costs per patient were £27,293 (sd 80,985) and mean duration of contact with services was 1490 (sd 757) days (approximately 4 years). Regression analysis showed that higher costs were associated with diagnosis of psychotic disorder (p < 0.001) and experiences of pre-trafficking violence (p = 0.06). Patients diagnosed with psychotic disorders cost approximately £32,635 more than patients with non-psychotic disorders/psychological distress but no formal diagnosis and patients whose clinical notes documented pre-trafficking violence cost £88,633 more than patients for whom pre-trafficking violence was not documented. CONCLUSIONS: Trafficked patients' use of mental health services - and the cost of providing care - is highly variable, but patients with psychotic disorders and with experiences of pre-trafficking violence are likely to require more intensive support. Evidence is needed on the effectiveness of interventions to promote the recovery of survivors of human trafficking.

Cost-effectiveness analysis of a communication-focused therapy for pre-school children with autism: results from a randomised controlled trial.

BACKGROUND: Autism is associated with impairments that have life-time consequences for diagnosed individuals and a substantial impact on families. There is growing interest in early interventions for children with autism, yet despite the substantial economic burden, there is little evidence of the cost-effectiveness of such interventions with which to support resource allocation decisions. This study reports an economic evaluation of a parent-mediated, communication-focused therapy carried out within the Pre-School Autism Communication Trial (PACT). METHODS: 152 pre-school children with autism were randomly assigned to treatment as usual (TAU) or PACT + TAU. Primary outcome was severity of autism symptoms at 13-month follow-up. Economic data included health, education and social services, childcare, parental productivity losses and informal care. RESULTS: Clinically meaningful symptom improvement was evident for 53 % of PACT + TAU versus 41 % of TAU (odds ratio 1.91, p = 0.074). Service costs were significantly higher for PACT + TAU (mean difference £4,489, p < 0.001), but the difference in societal costs was smaller and non-significant (mean difference £1,385, p = 0.788) due to lower informal care rates for PACT + TAU. CONCLUSIONS: Improvements in outcome generated by PACT come at a cost. Although this cost is lower when burden on parents is included, the cost and effectiveness results presented do not support the cost-effectiveness of PACT + TAU compared to TAU alone. TRIAL REGISTRATION: Current Controlled Trials ISRCTN58133827.

The clinical effectiveness, cost-effectiveness and acceptability of community-based interventions aimed at improving or maintaining quality of life in children of parents with serious mental illness: a systematic review.

BACKGROUND: Serious parental mental illness poses a challenge to quality of life (QoL) in a substantial number of children and adolescents. Improving the lives of these children is a political and public health concern. OBJECTIVES: To conduct an evidence synthesis of the clinical effectiveness, cost-effectiveness and acceptability of community-based interventions for improving QoL in children of parents with serious mental illness (SMI). DATA SOURCES: Nineteen health, allied health and educational databases, searched from database inception to May 2012, and supplemented with hand searches, reference checking, searches of grey literature, dissertations, ongoing research registers, forward citation tracking and key author contact. REVIEW METHODS: Inclusion criteria required≥50% of parents to have SMI or severe depression confirmed by clinical diagnosis or baseline symptoms. Children were ≤18 years of age. Community-based interventions included any non-residential psychological/psychosocial intervention involving parents or children for the purposes of improving health or well-being. Intervention comparators were not predefined and primary outcomes were validated measures of children's QoL and emotional health. Secondary outcomes were derived from UK policy and stakeholder consultation. Data were extracted independently by two reviewers and the study quality was assessed via Cochrane criteria for randomised/non-randomised designs, Critical Appraisal Skills Programme (CASP) qualitative criteria or a standard checklist for economic evaluations. Separate syntheses were conducted for SMI and severe depression. Standardised effect size (ES) trials were pooled using random-effects modelling for which sufficient data were available. Economic data were summarised and acceptability data were synthesised via a textual narrative approach. RESULTS: Three trials targeted mothers/the children of mothers with psychotic symptoms. Children were ≤12 years of age and no primary QoL or emotional health outcomes were reported. Insufficient secondary outcome data prevented pooling and no eligible economic evaluations were found. Twenty-six trials targeted parents/children of parents with severe depression; 18 recruited mothers of infants<2.5 years of age. Data pooling suggested no significant short-term effect on children's emotional health [standardised ES 0.06, 95% confidence interval (CI) -0.20 to 0.33] or social function (standardised ES 0.23, 95% CI 0.00 to 0.46). Medium to large effects were observed for parents' depressive symptoms (standardised ES 0.73, 95% CI 0.51 to 0.94) and parenting behaviours (standardised ES 0.67, 95% CI 0.32 to 1.02). One non-randomised economic evaluation was found. Intervention uptake and adherence were inconsistently reported. Incomplete evidence highlighted potential barriers from child custody losses and conflicting life circumstances. Qualitative data suggesting interventions to overcome social isolation and stigma are well received by parents. Limited data suggested that children may value peer interactions and normalising activities. LIMITATIONS: Included trials were of poor or unclear quality with inadequate randomisation or allocation concealment, possible attrition biases and incomplete outcome reporting. Meaningful analysis was challenged by clinical and methodological heterogeneity and insufficient data for subgroup comparisons. Children's self-reports were lacking and evidence of effect remains biased towards parent-based interventions for severely depressed mothers of infants. Generalisability to other diagnoses, older children and children of fathers with SMI is unclear. A lack of high-quality economic data prevented economic modelling. CONCLUSION: Evidence for community-based interventions to enhance QoL in children of SMI parents is lacking. The capacity to recommend evidence-based approaches is limited. Rigorous development work is needed to establish feasible and acceptable child- and family-based interventions, prior to evaluating clinical effectiveness and cost-effectiveness via a randomised controlled trial (RCT). A substantial programme of pilot work is recommended to underpin the development of feasible and acceptable interventions for this population. Evaluations should incorporate validated, child-centred QoL outcome measures, high-quality cost data and nested, in-depth acceptability studies. New age-appropriate instruments that better reflect the life priorities and unique challenges faced by children of parents with SMI may need to be developed. FUNDING: This report was commissioned by the NHS R&D Health Technology Assessment programme and funded by the National Institute for Health Research Health Technology Assessment programme.

Cost-effectiveness of injectable opioid treatment v. oral methadone for chronic heroin addiction.

BACKGROUND: Despite evidence of the effectiveness of injectable opioid treatment compared with oral methadone for chronic heroin addiction, the additional cost of injectable treatment is considerable, and cost-effectiveness uncertain. AIMS: To compare the cost-effectiveness of supervised injectable heroin and injectable methadone with optimised oral methadone for chronic refractory heroin addiction. METHOD: Multisite, open-label, randomised controlled trial. Outcomes were assessed in terms of quality-adjusted life-years (QALYs). Economic perspective included health, social services and criminal justice resources. RESULTS: Intervention costs over 26 weeks were significantly higher for injectable heroin (mean £8995 v. £4674 injectable methadone and £2596 oral methadone; P<0.0001). Costs overall were highest for oral methadone (mean £15 805 v. £13 410 injectable methadone and £10 945 injectable heroin; P = n.s.) due to higher costs of criminal activity. In cost-effectiveness analysis, oral methadone was dominated by injectable heroin and injectable methadone (more expensive and less effective). At willingness to pay of £30 000 per QALY, there is a higher probability of injectable methadone being more cost-effective (80%) than injectable heroin. CONCLUSIONS: Injectable opioid treatments are more cost-effective than optimised oral methadone for chronic refractory heroin addiction. The choice between supervised injectable heroin and injectable methadone is less clear. There is currently evidence to suggest superior effectiveness of injectable heroin but at a cost that policy makers may find unacceptable. Future research should consider the use of decision analytic techniques to model expected costs and benefits of the treatments over the longer term.

Economic evaluation of multisystemic therapy for young people at risk for continuing criminal activity in the UK.

OBJECTIVE: To evaluate whether multisystemic therapy (MST) is more cost-effective than statutory interventions that are currently available for young offenders in England. METHOD: A cost-offset evaluation of MST based on data from a randomised controlled trial conducted in North London, England, comparing MST with usual services provided by two youth offending teams (YOT). Service costs were compared to cost savings in terms of rates of criminal re-offending. RESULTS: 108 adolescents, aged 11-17 years, were randomly allocated to MST+YOT (n = 56) or YOT alone (n = 52). Reductions in offending were evident in both groups, but were higher in the MST+YOT group. At 18-month follow-up, the MST+YOT group cost less in terms of criminal activity (£9,425 versus £11,715, p = 0.456). The MST+YOT group were significantly cheaper in terms of YOT services than the YOT group (£3,402 versus £4,619, p = 0.006), but more expensive including the cost of MST, although not significantly so (£5,687 versus £4,619, p = 0.195). The net benefit per young person for the 18-month follow-up was estimated to be £1,222 (95% CI -£5,838 to £8,283). CONCLUSIONS: The results reported in this study support the finding that MST+YOT has scope for cost-savings when compared to YOT alone. However, the limitations of the study in terms of method of economic evaluation, outcome measures used and data quality support the need for further research.