METHODS: We did a parallel, two-arm, prospective observational study of opioid-dependent individuals aged 18 years and older who were treated in Malaysia in the Klang Valley in two settings: CDDCs and VTCs. We used sequential sampling to recruit individuals. Assessed individuals in CDDCs were required to participate in services such as counselling sessions and manual labour. Assessed individuals in VTCs could voluntarily access many of the components available in CDDCs, in addition to methadone therapy. We undertook urinary drug tests and behavioural interviews to assess individuals at baseline and at 1, 3, 6, 9, and 12 months post-release. The primary outcome was time to opioid relapse post-release in the community confirmed by urinary drug testing in individuals who had undergone baseline interviewing and at least one urine drug test (our analytic sample). Relapse rates between the groups were compared using time-to-event methods. This study is registered at ClinicalTrials.gov (NCT02698098).
FINDINGS: Between July 17, 2012, and August 21, 2014, we screened 168 CDDC attendees and 113 VTC inpatients; of these, 89 from CDDCs and 95 from VTCs were included in our analytic sample. The baseline characteristics of the two groups were similar. In unadjusted analyses, CDDC participants had significantly more rapid relapse to opioid use post-release compared with VTC participants (median time to relapse 31 days [IQR 26-32] vs 352 days [256-unestimable], log rank test, p<0·0001). VTC participants had an 84% (95% CI 75-90) decreased risk of opioid relapse after adjustment for control variables and inverse propensity of treatment weights. Time-varying effect modelling revealed the largest hazard ratio reduction, at 91% (95% CI 83-96), occurs during the first 50 days in the community.
INTERPRETATION: Opioid-dependent individuals in CDDCs are significantly more likely to relapse to opioid use after release, and sooner, than those treated with evidence-based treatments such as methadone, suggesting that CDDCs have no role in the treatment of opioid-use disorders.
FUNDING: The World Bank Group, Doris Duke Charitable Foundation, National Institute on Drug Abuse, Australian National Health & Medical Research Council, National Institute of Mental Health, and the University of Malaya-Malaysian Ministry of Higher Education High Impact Research Grant.
METHODS: Retrospective study of 182 neonates with HIE and managed with TH. The predominant pattern of HIE brain injury on MRI performed following cooling was scored by neuroradiologists. The electroencephalogram (EEG) background and evoked potential (EP) response, were analyzed. Area under the curve (AUC) of these tools for adverse outcome including death and/or moderate disabilities using the Bayley-III at 36 months were calculated. A stepwise model approach was used to reach the final most efficient predictive model.
RESULTS: Of 182 neonates, 99 were male (54.4 %), with median gestational age of 39 weeks (IQR 38-40) and median weight of 3.3 kg (IQR 2.9-3.7). On admission, 47 (26 %), 104 (57 %) and 31(17 %) neonates presented with mild, moderate and severe encephalopathy respectively. In multivariate analysis of 129 infants who received all prognostic modalities, the predictive value of a model of EEG plus MRI, AUC = 84 %) is equivalent to models of EEG plus MRI with added EP and clinical assessment at discharge (AUC = 84 and 85 % respectively).
CONCLUSION: In the era of cooling for neonatal HIE, the combination of EEG background and MRI during the first few days of life, provide an objective and highly reliable model for prediction of death and long-term disabilities.