[Show abstract][Hide abstract] ABSTRACT: The Cannabinoid Use in Progressive Inflammatory brain Disease (CUPID) trial aimed to determine whether or not oral Δ(9)-tetrahydrocannabinol (Δ(9)-THC) slowed the course of progressive multiple sclerosis (MS); evaluate safety of cannabinoid administration; and, improve methods for testing treatments in progressive MS.
There were three objectives in the CUPID study: (1) to evaluate whether or not Δ(9)-THC could slow the course of progressive MS; (2) to assess the long-term safety of Δ(9)-THC; and (3) to explore newer ways of conducting clinical trials in progressive MS.
The CUPID trial was a randomised, double-blind, placebo-controlled, parallel-group, multicentre trial. Patients were randomised in a 2 : 1 ratio to Δ(9)-THC or placebo. Randomisation was balanced according to Expanded Disability Status Scale (EDSS) score, study site and disease type. Analyses were by intention to treat, following a pre-specified statistical analysis plan. A cranial magnetic resonance imaging (MRI) substudy, Rasch measurement theory (RMT) analyses and an economic evaluation were undertaken.
Twenty-seven UK sites.
Adults aged 18-65 years with primary or secondary progressive MS, 1-year evidence of disease progression and baseline EDSS 4.0-6.5.
Oral Δ(9)-THC (maximum 28 mg/day) or matching placebo.
Three and 6 months, and then 6-monthly up to 36 or 42 months.
Primary outcomes were time to EDSS progression, and change in Multiple Sclerosis Impact Scale-29 version 2 (MSIS-29v2) 20-point physical subscale (MSIS-29phys) score. Various secondary patient- and clinician-reported outcomes and MRI outcomes were assessed. RMT analyses examined performance of MS-specific rating scales as measurement instruments and tested for a symptomatic or disease-modifying treatment effect. Economic evaluation estimated mean incremental costs and quality-adjusted life-years (QALYs).
Effectiveness - recruitment targets were achieved. Of the 498 randomised patients (332 to active and 166 to placebo), 493 (329 active and 164 placebo) were analysed. Primary outcomes: no significant treatment effect; hazard ratio EDSS score progression (active : placebo) 0.92 [95% confidence interval (CI) 0.68 to 1.23]; and estimated between-group difference in MSIS-29phys score (active-placebo) -0.9 points (95% CI -2.0 to 0.2 points). Secondary clinical and MRI outcomes: no significant treatment effects. Safety - at least one serious adverse event: 35% and 28% of active and placebo patients, respectively. RMT analyses - scale evaluation: MSIS-29 version 2, MS Walking Scale-12 version 2 and MS Spasticity Scale-88 were robust measurement instruments. There was no clear symptomatic or disease-modifying treatment effect. Economic evaluation - estimated mean incremental cost to NHS over usual care, over 3 years £27,443.20 per patient. No between-group difference in QALYs.
The CUPID trial failed to demonstrate a significant treatment effect in primary or secondary outcomes. There were no major safety concerns, but unwanted side effects seemed to affect compliance. Participants were more disabled than in previous studies and deteriorated less than expected, possibly reducing our ability to detect treatment effects. RMT analyses supported performance of MS-specific rating scales as measures, enabled group- and individual person-level examination of treatment effects, but did not influence study inferences. The intervention had significant additional costs with no improvement in health outcomes; therefore, it was dominated by usual care and not cost-effective. Future work should focus on determining further factors to predict clinical deterioration, to inform the development of new studies, and modifying treatments in order to minimise side effects and improve study compliance. The absence of disease-modifying treatments in progressive MS warrants further studies of the cannabinoid pathway in potential neuroprotection.
Current Controlled Trials ISRCTN62942668.
The National Institute for Health Research Health Technology Assessment programme, the Medical Research Council Efficacy and Mechanism Evaluation programme, Multiple Sclerosis Society and Multiple Sclerosis Trust. The report will be published in full in Health Technology Assessment; Vol. 19, No. 12. See the NIHR Journals Library website for further project information.
Preview · Article · Feb 2015 · Health technology assessment (Winchester, England)
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Multiple sclerosis (MS) is a chronic neurological disorder, which can lead to a wide range of disabling symptoms. The condition has a significant negative impact on health-related quality of life, and the economic cost of the disease is substantial. Decision-making regarding treatments for MS, and particularly disease-modifying interventions, has been hampered by limitations in the data and evaluative framework for assessing their cost effectiveness. Whilst attention has been drawn to these weaknesses, the scope and extent of the challenges in this area have not been fully set out to date. AIMS: The aims of this review were to identify all published economic evaluations of MS treatments in order to provide a statement on the scope and characteristics of the cost-effectiveness literature in the area of MS and to provide a basis on which to suggest practical recommendations for future research to aid decision-making. METHOD: A systematic search was undertaken to identify economic evaluations of treatments for people with MS published in English up to December 2011. Included studies were reviewed to provide a comprehensive description of the characteristics of the currently applied framework for cost effectiveness in MS, with the following key methodological components considered: methods for estimating disease progression, the impact of treatment and health outcomes and costs associated with MS. RESULTS: Thirty-seven papers were identified. Most studies (n = 32) were model-based evaluations of disease-modifying drugs. All models used disability stages defined by the Expanded Disability Status Scale (EDSS) to characterise disease progression, and the impact of treatment was based on data from clinical trials and epidemiological cohorts. Outcomes were primarily based on quality-adjusted life-years (n = 22) and/or related to relapse (n = 14). Estimates for health state utility values (HSUVs), costs and the impact of treatment on the course of MS varied considerably between studies, depending on the data sources used and the methods used to incorporate data into models. The scope of the studies was narrow, with a sparsity of economic evaluations of symptomatic and/or non-pharmacological interventions; exclusion of direct non-medical, indirect and informal care costs from analyses; and a narrow view of the potential impact of treatment, concentrating on disability, according to the EDSS, and relapses. In addition, there were issues concerning how to capture losses in HSUVs due to relapses in a way that reflects their salience to people with MS, the wide variation in costs and outcomes from different sources and from potentially unrepresentative samples and modelling disease progression from natural history data from over 30 years ago. CONCLUSION: There are many complexities for those designing and reporting cost-effectiveness studies of treatments for MS. Analysts, and ultimately decision makers, face multiple data and methodological challenges. Policy makers, technology developers, clinicians, patients and researchers need to acknowledge and address these challenges and to consider recommendations that will improve the current scenario. There is a need for further research that can constructively inform decision-making regarding the funding of treatments for MS.
No preview · Article · May 2013 · Applied Health Economics and Health Policy
[Show abstract][Hide abstract] ABSTRACT: Background
Spasticity is common in patients with multiple sclerosis (MS) and is a major contributor to disability. Sativex®, an oromucosal spray containing cannabis-based medicinal products, has been found to be effective in reducing spasticity symptoms.
Our objective was to estimate the cost effectiveness of Sativex® plus oral anti-spasticity medicines compared with the current standard treatment for moderate or severe spasticity in MS in the UK.
A Markov model was used to assess the costs and benefits of Sativex® plus oral anti-spasticity medicines or current standard treatment based on their effects on the quality of life of patients. The main outcome was the incremental cost-effectiveness ratio (ICER) in terms of costs per additional QALY gained over 5 years of treatment. One-way, multi-way and probabilistic sensitivity analyses were conducted to explore the impact of uncertainties on the findings.
In the base case, Sativex® plus oral anti-spasticity medicines resulted in incremental costs of d7600 and a QALY gain of 0.15 per person over 5 years (ICER = £49 300 per QALY) [year 2009 data for costs]. Findings were sensitive to the costs of Sativex® (price and dose) and differences in utilities between responders and non-responders.
Using a willingness-to-pay threshold of £30 000 per QALY, Sativex® appears unlikely to be considered cost effective by UK funders of healthcare for spasticity in MS. This is unfortunate, since it appears that Sativex® use is likely to benefit some patients in the management of this common consequence of MS.
No preview · Article · Oct 2012 · PharmacoEconomics
[Show abstract][Hide abstract] ABSTRACT: Diagnosis of Alzheimers disease (AD) is often difficult, especially early in the disease process at the stage of mild cognitive impairment (MCI). Yet, it is at this stage that treatment is most likely to be effective, so there would be great advantages in improving the diagnosis process. We describe and test a machine learning approach for personalized and cost-effective diagnosis of AD. It uses locally weighted learning to tailor a classifier model to each patient and computes the sequence of biomarkers most informative or cost-effective to diagnose patients. Using ADNI data, we classified AD vs. controls and MCI patients who progressed to AD within a year, against those who did not. The approach performed similarly to considering all data at once, while significantly reducing the number (and cost) of the biomarkers needed to achieve a confident diagnosis for each patient. Thus, it may contribute to a personalized and effective detection of AD, and may prove useful in clinical settings.
Full-text · Article · Aug 2012 · IEEE transactions on bio-medical engineering
[Show abstract][Hide abstract] ABSTRACT: Alzheimer's disease (AD) is a chronic, progressive, neurodegenerative disease that places a heavy burden on people with the condition, their families and carers, health care systems and society in general. Health-related quality of life (HR-QOL) in patients deteriorates as the cognitive, behavioural and functional symptoms of AD develop. The human and financial cost of AD is forecast to grow rapidly as populations age, and those responsible for planning and financing health care face the challenge of allocating increasingly scarce resources against current and future interventions targeted towards AD. These include calls for early detection and diagnosis, preventative strategies, new medications, residential care, supportive care, and meeting the needs of carers as well as patients. Health care funders in many health systems now require a demonstration of the value of new interventions through a comparison of benefits in terms of improvements in HR-QOL and costs relative to those of competing or existing practices. Changes in HR-QOL provide the basis for the calculation of the quality-adjusted life-year (QALY), a key outcome used in economic evaluations to compare treatments within and between different disease conditions. The objective of this systematic review was to provide a summary of the published health state values (utilities) for AD patients and their carers that are currently available to estimate QALYs for use in health economic evaluations of interventions in AD. The health care literature was searched for articles published in English between 2000 and 2011, using keywords and variants including 'quality-adjusted life years', 'health state indicators', 'health utilities' and the specific names of generic measures of HR-QOL and health state valuation techniques. Databases searched included MEDLINE, EMBASE, NHS EED, PsycINFO and ISI Web of Science. This review identified 12 studies that reported utility values associated with health states in AD. Values for AD health states categorized according to cognitive impairment (where 1 = perfect health and 0 = dead) ranged from mild AD (0.52-0.73) to moderate AD (0.30-0.53) to severe AD (0.12-0.49). Utility values were almost all based on two generic measures of HR-QOL: the EQ-5D and Health Utility Index mark 2/3 (HUI2/3). There were no health state values estimated from condition- or disease-specific measures of HR-QOL. The review also identified 18 published cost-utility analyses (CUAs) of treatments for AD. The CUAs incorporated results from only three of the identified health state valuation studies. Twelve CUAs relied on the same study for health state values. We conclude that the literature on health state values in AD is limited and overly reliant on a single symptom (cognition) to describe disease progression. Other approaches to characterizing disease progression in AD based on multiple outcomes or dependency may be better predictors of costs and utilities in economic evaluations. Patient and proxy ratings were poorly correlated, particularly in patients with more advanced AD. However, proxy ratings displayed the validity and reliability across the entire range of AD severity needed to detect long-term changes relevant to economic evaluation. Further longitudinal research of patient and carer HR-QOL based on multidimensional measures of outcome and utilities is needed.
[Show abstract][Hide abstract] ABSTRACT: The aim of the study was to estimate health state utility values in newly diagnosed idiopathic Parkinson's disease (PD) for use in the assessment of health-related quality-of-life (HRQL), and in the estimation of quality-adjusted life-years (QALYs). Data from 162 patients enrolled in a community-based incidence study of PD were used to estimate health state utility values. Self-report data from the EQ-5D, a generic measure of HRQL, were used to derive preference-based health state utility values. The impact of motor and non motor symptoms, and other clinical and demographic factors, on the derived EQ-5D health state values was examined in univariate and multivariate analyses. The mean health state utility value for recently diagnosed PD patients was estimated at 0.65 ± 0.27. Significant reductions in health state values were attributable to pain (-0.18), motor functioning (-0.16), depression (-0.12), and insomnia (-0.11). Depression had its greatest impact (-0.19) in patients in the less severe stages of PD (i.e. Hoehn Yahr stages ≤2.5). This study shows, through the presentation of QALY values, that there is scope to achieve significant health gains in newly diagnosed idiopathic PD patients via improved management of pain, depression and insomnia, alongside the treatment of primary motor symptoms.
No preview · Article · Aug 2011 · Journal of Neurology
[Show abstract][Hide abstract] ABSTRACT: To consider the methods available to model Alzheimer's disease (AD) progression over time to inform on the structure and development of model-based evaluations, and the future direction of modelling methods in AD.
A systematic search of the health care literature was undertaken to identify methods to model disease progression in AD. Modelling methods are presented in a descriptive review.
The literature search identified 42 studies presenting methods or applications of methods to model AD progression over time. The review identified 10 general modelling frameworks available to empirically model the progression of AD as part of a model-based evaluation. Seven of these general models are statistical models predicting progression of AD using a measure of cognitive function. The main concerns with models are on model structure, around the limited characterization of disease progression, and on the use of a limited number of health states to capture events related to disease progression over time. None of the available models have been able to present a comprehensive model of the natural history of AD.
Although helpful, there are serious limitations in the methods available to model progression of AD over time. Advances are needed to better model the progression of AD and the effects of the disease on peoples' lives. Recent evidence supports the need for a multivariable approach to the modelling of AD progression, and indicates that a latent variable analytic approach to characterising AD progression is a promising avenue for advances in the statistical development of modelling methods.
[Show abstract][Hide abstract] ABSTRACT: The aims of this review were to review decision-analytic models used to evaluate interventions in idiopathic Parkinson’s disease (PD), and to consider the future directions for development of methods to model the progression of PD over time.
A systematic search of the healthcare literature up to June 2010 identified model-based economic evaluations in PD. The modelling methods used in the identified studies were appraised using good practice guidelines for decision-analytic modelling.
The review identified 18 model-based evaluations of interventions in PD. All models evaluated treatments targeted towards the motor symptoms of PD or the motor complications of PD treatment. There were no models identified that evaluated interventions targeted towards the non-motor symptoms of PD, such as neuropsychiatric problems or autonomic dysfunction. Consequently, models characterized disease progression in PD using clinical measures of motor functioning. Most studies (n = 13) evaluated medications, three evaluated diagnostic technologies and two examined surgical procedures. Overall, the models reported structural components and data inputs appropriately and clearly, although limited evidence was provided to support choices made on the structures used in the models or the data synthesis reported. Models did not adequately consider structural uncertainty or internal/external consistency.
Modelling methods used to date do not capture the full impact of PD. The emphasis in the current literature is on the motor symptoms of PD, characterizing the clinical nature of disease progression, largely neglecting the important impacts of non-motor symptoms. Modelling methods reported for the motor symptoms of PD may not be suitable for future interventions targeted towards modifying disease progression in PD across the entire spectrum of PD. More comprehensive models of disease progression, including both motor and non-motor symptoms will be needed where it is important to capture the effects of interventions more broadly.
No preview · Article · Jul 2011 · Applied Health Economics and Health Policy
[Show abstract][Hide abstract] ABSTRACT: To examine the cost-effectiveness of modafinil (200 mg daily) plus counselling compared with placebo for the treatment of psychostimulant dependence.
Cost and outcome data were collected alongside two randomised controlled trials of modafinil 200 mg daily over 10 weeks for methamphetamine (n = 74) and cocaine dependence (n = 8), respectively. Incremental cost-effectiveness ratios representing the additional costs to achieve a given outcome were calculated for both the change in the number of stimulant-free days and quality-adjusted life years 12 weeks post-treatment.
The incremental cost-effectiveness ratio indicated that it would cost an additional $AUD79 to achieve an extra stimulant-free day with modafinil compared with placebo. This result was not statistically significant, but appeared to be a robust estimate after sensitivity analysis. Counselling, whether received within program or from other services, improved the cost-effectiveness of modafinil relative to placebo.
Strategies to improve the uptake of counselling are recommended as cost-effective.
No preview · Article · May 2010 · Drug and Alcohol Review
[Show abstract][Hide abstract] ABSTRACT: To examine the safety and efficacy of modafinil (200 mg/day) compared to placebo in the treatment of methamphetamine dependence and to examine predictors of post-treatment outcome.
Eighty methamphetamine-dependent subjects in Sydney, Australia were allocated randomly to modafinil (200 mg/day) (n = 38) or placebo (n = 42) under double-blind conditions for 10 weeks with a further 12 weeks post-treatment follow-up.
Comprehensive drug use data (urine specimens and self-report) and other health and psychosocial data were collected weekly during treatment and research interviews at baseline, week 10 and week 22.
Treatment retention and medication adherence were equivalent between groups. There were no differences in methamphetamine abstinence, craving or severity of dependence. Medication-compliant subjects tended to provide more methamphetamine-negative urine samples over the 10-week treatment period (P = 0.07). Outcomes were better for methamphetamine-dependent subjects with no other substance dependence and those who accessed counselling. There were statistically significant reductions in systolic blood pressure (P = 0.03) and weight gain (P = 0.05) in modafinil-compliant subjects compared to placebo. There were no medication-related serious adverse events. Adverse events were generally mild and consistent with known pharmacological effects.
Modafinil demonstrated promise in reducing methamphetamine use in selected methamphetamine-dependent patients. The study findings support definitive trials of modafinil in larger multi-site trials.
[Show abstract][Hide abstract] ABSTRACT: Psychostimulant dependence is a chronic, relapsing condition which is highly treatment refractory. No medications to date have been any more successful than placebo in reducing psychostimulant use in dependent patients. Agonist strategies have attracted limited attention.
Successful examples of agonist pharmacotherapy in the treatment of heroin and nicotine dependence are first considered. Agonist pharmacological approaches to the treatment of psychostimulant dependence are then examined, based on the dopamine receptor agonist and indirect dopamine agonist strategies. Finally, the potential extension of the concept of agonist pharmacotherapy to include the novel non-amphetamine-type stimulant, modafinil, is discussed.
Agonist approaches appear to be viable with risks outweighed by benefits in carefully selected, monitored and motivated patients. On the other hand, the effectiveness of indirect agonists such as dexamphetamine and methylphenidate are not established. Further research is required to determine optimal treatment models (whether maintenance or withdrawal), effective safe dosages and duration (short or long term).
No preview · Article · Jun 2008 · Drug and Alcohol Review
[Show abstract][Hide abstract] ABSTRACT: The aim of this paper was to explore the nature of cocaine use and harms through a cross-sectional survey of cocaine users interviewed in the two largest Australian cities of Sydney (n = 88) and Melbourne (n = 77) between October 2004 and January 2005. The study supported previous findings that Australian cocaine users could be classified broadly into two types. The majority of cocaine users interviewed were classified as socially and economically integrated. They were young, employed, well-educated people who generally snorted cocaine on a recreational basis, typically in conjunction with other illicit and licit drugs. A second group of socially and economically marginalised users, residing mainly in Sydney, injected cocaine often in conjunction with heroin. This group reported significantly higher levels of cocaine use, cocaine dependence, criminal behaviour and human immunodeficiency virus (HIV) risk-taking behaviour. Heroin use was found to predict independently higher levels of cocaine use, criminal behaviour, needle sharing and physical problems in this sample, suggesting that increased resources and coverage for combined heroin/cocaine users may have scope for reducing cocaine-related problems in the Australian community.
No preview · Article · Oct 2007 · Drug and Alcohol Review
[Show abstract][Hide abstract] ABSTRACT: The study evaluated the introduction of naltrexone in an Australian prison system for imprisoned male heroin users. Treatment outcomes were analysed for two sub-samples taken from an unsuccessful randomised controlled trial. The first sample comprised 68 participants who were randomly allocated to naltrexone treatment. The second sample comprised 47 participants who commenced opioid pharmacotherapy during the study period. Thirteen per cent of subjects started naltrexone, with only 7% retained in treatment at six months. Six-month retention was significantly lower in naltrexone compared to methadone (p=0.0007). Poor patient acceptability and retention did not support oral naltrexone maintenance in this treatment group.
No preview · Article · Sep 2007 · International Journal of Prisoner Health
[Show abstract][Hide abstract] ABSTRACT: Twenty Australian cocaine dealers were interviewed regarding cocaine sales and related issues. Most money was made by cocaine importers and by those selling small, diluted quantities to injecting drug users (IDU), with lower returns made by suppliers to recreational drug users. Australian domestic cocaine transactions appear to occur within private social networks which are difficult to disrupt, with little impact on the volume and price of cocaine. Given the large-scale importations required to support the Australian market, law enforcement efforts at the border and beyond are likely to be the most effective supply reduction strategy.
Preview · Article · Mar 2007 · The Howard Journal of Criminal Justice
[Show abstract][Hide abstract] ABSTRACT: This review examines the nature and evidence for the effectiveness of psychosocial interventions for psychostimulant dependence. Psychostimulant dependence and related harms continue to increase in many parts of the world, while treatment responses are predominantly limited to psychosocial interventions. The effectiveness of psychosocial interventions is compromised by poor rates of treatment induction and retention. As with other substance use disorders, increasing the diversity of treatment options is likely to improve treatment coverage and outcomes across a broader range of users. Identifying medications that might enhance treatment induction and retention would also enhance the effectiveness of psychosocial programs. It is concluded that psychosocial interventions are moderately effective in reducing psychostimulant use and related harms among psychostimulant-dependent persons.
No preview · Article · Feb 2007 · Journal of Substance Abuse Treatment
[Show abstract][Hide abstract] ABSTRACT: To identify which smoking cessation interventions provide the most efficient use of health care resources at a population level.
Effectiveness data were obtained from a review of the international literature. Costs and effects of smoking cessation interventions were estimated from the perspective of the Australian Government. Treatment costs and effects were modelled using incremental cost-effectiveness ratios. Assumptions regarding effectiveness, resource use and costs were tested by sensitivity analysis.
From the population perspective, telephone counselling appeared to be the most cost-effective intervention. Adding proactive forms of telephone counselling increased the effectiveness of pharmacotherapies at a low incremental cost and, therefore, this could be a highly cost-effective strategy. Bupropion appeared to be more cost effective than nicotine replacement therapy (NRT). Combined bupropion and NRT did not appear to be cost effective.
General practitioners should be encouraged to refer patients to telephone quit lines and if prescribing pharmacotherapy consider the addition of telephone counselling.
The results support greater investment in proactive forms of telephone counselling and more formal integration of pharmacotherapies with proactive telephone counselling services as cost-effective strategies for reducing population-level smoking rates.
No preview · Article · Nov 2006 · Australian and New Zealand Journal of Public Health
[Show abstract][Hide abstract] ABSTRACT: Although methadone maintenance treatment in community settings is known to reduce heroin use, HIV infection and mortality among injecting drug users (IDU), little is known about prison methadone programs. One reason for this is the complexity of undertaking evaluations in the prison setting. This paper estimates the cost-effectiveness of the New South Wales (NSW) prison methadone program.
Information from the NSW prison methadone program was used to construct a model of the costs of the program. The information was combined with data from a randomised controlled trial of provision of prison methadone in NSW. The total program cost was estimated from the perspective of the treatment provider/funder. The cost per heroin free day, compared with no prison methadone, was estimated. Assumptions regarding resource use were tested through sensitivity analysis.
The annual cost of providing prison methadone in NSW was estimated to be 2.9 million Australian dollars (or 3,234 Australian dollars per inmate per year). The incremental cost effectiveness ratio is 38 Australian dollars per additional heroin free day.
From a treatment perspective, prison methadone is no more costly than community methadone, and provides benefits in terms of reduced heroin use in prisons, with associated reduction in morbidity and mortality.
No preview · Article · Oct 2006 · Drug and Alcohol Dependence
[Show abstract][Hide abstract] ABSTRACT: The value of hair analysis in measuring treatment outcome was examined in a randomised controlled trial (RCT) of an Australian state prison-based methadone programme between 1997 and 1998 (n = 382 male prisoners). Hair samples were analysed for morphine using immunoassay techniques. Agreement between hair analysis and self-report was tested using kappa, McNemar's test of symmetry and Pearson's correlation coefficient r. Hair analysis based on immunoassay was inadequate as the primary outcome measure for the RCT but had value in supplementing self-reported heroin use. There was a modest correlation (r = 0.31, p < 0.001) between self-reported frequency of heroin use and morphine concentrations in hair. Sectional hair analysis, a reflection of duration of drug use, was uninformative and generally impractical due to the length of hair sections needed.
No preview · Article · Sep 2006 · Drug and Alcohol Review
[Show abstract][Hide abstract] ABSTRACT: To examine the long-term impact of methadone maintenance treatment (MMT) on mortality, re-incarceration and hepatitis C seroconversion in imprisoned male heroin users.
The study cohort comprised 382 imprisoned male heroin users who had participated in a randomized controlled trial of prison-based MMT in 1997/98. Subjects were followed-up between 1998 and 2002 either in the general community or in prison.
All-cause mortality, re-incarceration, hepatitis C and HIV serostatus and MMT retention.
There were no deaths recorded while subjects were enrolled in MMT. Seventeen subjects died while out of MMT, representing an untreated mortality rate of 2.0 per 100 person-years (95% CI, 1.2-3.2). Re-incarceration risk was lowest during MMT episodes of 8 months or longer (adjusted hazard ratio 0.3 (95% CI, 0.2-0.5; P < 0.001), although MMT periods 2 months or less were associated with greatest risk of re-incarceration (P < 0.001). Increased risk of hepatitis C seroconversion was significantly associated with prison sentences of less than 2 months [adjusted hazard ratio 20 (95% CI, 5-76; < P = 0.001)] and MMT episodes less than 5 months [adjusted hazard ratio 4.2 (95% CI, 1.4-12.6; P = 0.01)]. Subjects were at greatest risk of MMT dropout during short prison sentences of 1 month or less (adjusted hazard ratio 10.4 (95% CI, 7.0-15.7; P < 0.001). HIV incidence was 0.3 per 100 person-years (95% CI, 0.03-0.99).
Retention in MMT was associated with reduced mortality, re-incarceration rates and hepatitis C infection. Prison-based MMT programmes are integral to the continuity of treatment needed to ensure optimal outcomes for individual and public health.