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 Overall (including withdrawn subjects or those lost to follow-up), there was a 1.71-fold increase in hospital admission and a 3.09-fold increase in ED attendance recorded.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

Get full access to this article

View all access options for this article.

References

Weissman

Schneider

Weingart

. Comparing patient-reported hospital adverse events with medical record review: Do patients know something that hospitals do not? Ann Intern Med 2008; 149(2): 100–10.

Sims

ACP

. Importance of a high tracing-rate in long-term medical follow-up studies. Lancet 1973; 302(7826): 433–35.

Digiusto

Panjari

Gibson

Rea

; NEPOD Research Group. Follow up difficulty: Correlates and relationships with outcome in heroin dependence treatment in the NEPOD study. Addict Behav 2006; 31(7): 1201–10.

United Nations Office on Drugs and Crime. World drug report 2009. United Nations Office on Drugs and Crime, Vienna, 2009.

McKeganey

Bloor

Robertson

. Abstinence and drug abuse treatment: Results from the drug outcome research in Scotland study. Drug-Educ Prev Polic 2006; 13(6): 537–50.

Comer

Sullivan

Hulse

. Sustained release naltrexone: Novel treatment for opioid dependence. Expert Opin Investig Drugs 2007; 16(8): 1285–94.

Kosten

Kleber

. Strategies to improve compliance with narcotic antagonists. Am J Drug Alcohol Abuse 1984; 10(2): 249–66.

Hulse

Morris

Arnold-Reed

Tait

. Improving clinical outcomes in treating heroin dependence: Randomized controlled trial of oral or implant naltrexone. Arch Gen Psychiatry 2009; 66(10): 1108–15.

Hulse

Ngo

HTT

Tait

. Risk factors for craving and relapse in heroin users treated with oral or implant naltrexone. Biol Psychiatry 2010; 68(3): 296–302.

10.

Therapeutic Goods Administration. The Australian Clinical Trial Handbook. Department of Health and Aging, Australian Government, Canberra, ACT, Australia, 2006.

11.

Therapeutic Goods Administration. Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95). Commonwealth Department of Health and Aged Care, Canberra, ACT, Australia, 2000.

12.

Therapeutic Goods Administration. Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (CPMP/ICH/377/95). Commonwealth Department of Health and Aging, Canberra, ACT, Australia, 2000.

13.

Brameld

Holman

Thomas

Bass

. Use of a state data bank to measure incidence and prevalence of chronic disease: End-stage renal failure. Am J Kidney Dis 1999; 34(6): 1033–39.

14.

Hulse

English

Milne

Holman

. The quantification of mortality resulting from the regular use of illicit opiates. Addiction 1999; 94(2): 221–29.

15.

Ngo

HTT

Tait

Hulse

. Comparing drug-related hospital morbidity following heroin dependence treatment with methadone maintenance of naltrexone implantation. Arch Gen Psychiatry 2008; 65(4): 457–65.

16.

Darke

. Self report among injecting drug users: A review. Drug Alcohol Depend 1998; 51: 253–63.

17.

Murray

Britton

Bulstrode

CJK

. Loss to follow up matters. J Bone Joint Surg Br 1997; 79(B): 254–57.

18.

Ndiaye

Ould-Kaci

Salleron

et al. Characteristics and outcomes in HIV-infected patients who return to care after being loss to follow-up. AIDS 2009; 23(13): 1786–89.

19.

Harris

Gospodarevskaya

Ritter

. A randomised trial of the cost effectiveness of buprenorphine as an alternative to methadone maintenance treatment for heroin dependence in a primary care setting. Pharmacoeconomics 2005; 23(1): 77–91.