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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.

AbstractBACKGROUND:
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 Overall (including withdrawn subjects or those lost to follow-up), there was a 1.71-fold increase in hospital admission and a 3.09-fold increase in ED attendance recorded.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.
AuthorsErin Kelty, Hanh Ngo, Gary Hulse
JournalClinical trials (London, England) (Clin Trials) Vol. 10 Issue 1 Pg. 170-80 (Feb 2013) ISSN: 1740-7753 [Electronic] England
PMID23241479 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Drug Implants
  • Naltrexone
Topics
  • Administration, Oral
  • Adverse Drug Reaction Reporting Systems
  • Data Collection
  • Drug Implants
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • Follow-Up Studies
  • Heroin Dependence (drug therapy)
  • Humans
  • Male
  • Naltrexone (administration & dosage)
  • Randomized Controlled Trials as Topic (methods)
  • Self Report

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