Assessing the usefulness of health data linkage in obtaining adverse event data in a randomised controlled trial of oral and implant naltrexone in the treatment of heroin dependence.
ABSTRACT BACKGROUND: The completeness of self-reported serious adverse events (SAEs) in clinical trials can be reduced by inaccuracies in subject reporting and lost to follow-up. PURPOSE: This study assesses the usefulness of a health data linkage system in obtaining SAE data in a randomised controlled study of oral and implant naltrexone. METHODS: SAEs were collected from 68 heroin-dependent subjects during a randomised controlled trial of oral and implant naltrexone with follow-up to 26 weeks. Patient self-report data were cross-matched against hospital and emergency department (ED) attendances for the same period using a health data linkage system. RESULTS: A total of 29 hospital admissions and 74 ED attendances were identified using health data linkage. Of these, 12 (41.4%) hospital admissions and 50 (67.7%) of ED attendances had not been reported as SAE in the randomised controlled trial. In subjects participating in the trial at the time of the event, there was a 1.25-fold increase in the number of hospital admissions and a 2.25-fold increase in the number of ED attendances recorded using data linkage. Overall (including withdrawn subjects or those lost to follow-up), there was a 1.71-fold increase in hospital admission and a 3.09-fold increase in ED attendance recorded. LIMITATIONS: The use of data linkage should not be used as a replacement for thorough follow-up, as the datasets can take substantial periods to update, making them a poor substitute for real-time follow-up. Additionally, some SAEs such as life-threatening events that do not involve ED or hospital attendance may be overlooked as would SAEs that occurred outside the dataset's range, for example, interstate or overseas. CONCLUSIONS: Health data linkage can be used to effectively reduce the extent of missing health data in a clinical trial.
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ABSTRACT: Naltrexone implants are used to treat opioid dependence, but their safety and efficacy remain poorly understood. We systematically reviewed the literature to assess the safety and efficacy of naltrexone implants for treating opioid dependence. Studies were eligible if they compared naltrexone implants with another intervention or placebo. Examined outcomes were induction to treatment, retention in treatment, opioid and non-opioid use, adverse events, non-fatal overdose and mortality. Quality of the evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation approach. Data from randomised studies were combined using meta-analysis. Data from non-randomised studies were presented narratively. Five randomised trials (n = 576) and four non-randomised studies (n = 8358) were eligible for review. The quality of the evidence ranged from moderate to very low. Naltrexone implants were superior to placebo implants [risk ratio (RR): 0.57; 95% confidence interval (CI) 0.48, 0.68; k = 2] and oral naltrexone (RR: 0.57; 95% CI 0.47, 0.70; k = 2) in suppressing opioid use. No difference in opioid use was observed between naltrexone implants and methadone maintenance (standardised mean difference: -0.33; 95% CI -0.93, 0.26; k = 1); however, this finding was based on low-quality evidence from one study. The evidence on safety and efficacy of naltrexone implants is limited in quantity and quality, and the evidence has little clinical utility in settings where effective treatments for opioid dependence are used. Better designed research is needed to establish the safety and efficacy of naltrexone implants. Until such time, their use should be limited to clinical trials. [Larney S, Gowing L, Mattick RP, Farrell M, Hall W, Degenhardt L. A systematic review and meta-analysis of naltrexone implants for the treatment of opioid dependence. Drug Alcohol Rev 2013].Drug and Alcohol Review 12/2013; · 1.55 Impact Factor