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. (February 2013)

• Record Type: Journal Article
• Authors: Kelty, Erin; Ngo, Hanh; Hulse, Gary
• Is Part Of: Clinical trials. Volume 10:Number 1(2013)Supplement
• Page Start: 170
• Page End: 180
• Publication Date: 2013-02
• Subjects: 615.5072405
• DOI: 10.1177/1740774512467237
• Languages: English
• ISSNs: 1740-7745

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 Overall (including withdrawn subjects or those lost to follow-up), there was a 1.71-fold increase in hospital admission and a 3.09-fold increase in ED attendance recorded.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