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

ArticleinClinical Trials 10(1) · December 2012with3 Reads
Impact Factor: 1.93 · DOI: 10.1177/1740774512467237 · Source: PubMed

    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 Overall (including withdrawn subjects or those lost to follow-up), there was a 1.71-fold increase in hospital admission and a 3.09-fold increase in ED attendance recorded.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.