Journal Club Alcohol, Other Drugs, and Health: Current Evidence April 2008

Featured Article Mortality prior to, during and after opioid maintenance treatment (OMT): a national prospective cross-registry study Clausen T, et al. Drug Alcohol Depend. 2008;94(1-3):

Study Objective To assess differences in mortality rates prior to, during, and after opioid maintenance treatment (OMT) in opioid-dependent patients To evaluate changes in mortality rates using an “intention-to-treat” perspective To examine the distribution of deaths attributable to drug overdose versus other causes

Study Design In this prospective cohort study, Norwegian researchers followed 3789 persons with opioid dependence over 7 years. Data were gathered and cross-linked from 2 national registries: –opioid dependent registry –death registry Subgroup data from the opioid dependent registry (persons on a waiting list for OMT, receiving OMT,* or who had discontinued OMT) were compared with death registry data. *predominantly methadone

Assessing Validity of an Article about Prognosis Are the results valid? What are the results? How can I apply the results to patient care?

Are the Results Valid? Was the sample representative? Were the subjects sufficiently homogeneous with respect to prognostic risk? Was follow-up sufficiently complete? Were objective and unbiased outcome criteria used?

Was the sample representative? All subjects in this study were… severely addicted to heroin. had several years of addiction dominated by opioid dependence. had not benefited from other types of treatment.

Were the subjects sufficiently homogeneous with respect to prognostic risk? The sample was divided into 3 groups: –Pretreatment (applicants qualifying for OMT but not yet receiving treatment, referred to as “waiting list”) –In treatment (receiving OMT) –Posttreatment (after termination of OMT) Female subjects constituted 31.9% of the sample. Ages ranged from 23 to 66 years. No information was presented on prognostic risk for death (e.g., comorbid medical/psychiatric conditions) or overdose.

Was follow-up sufficiently complete? The follow-up period ranged from 0 to 7 years.

Were objective and unbiased outcome criteria used? Mortality was determined via a death registry. The potential for bias existed in that... –overdose death was determined according to coroner records. –autopsy was performed in one-third of cases triggered by reasons not stated in the research report.

What Are the Results? How likely are the outcomes over time? How precise are the estimates of likelihood?

How likely are the outcomes over time? Mortality Rates per 100 Person-Years (CI) Treatment StatusOverdoseNonoverdoseTotal Pretreatment1.9 (1.6–2.1) 0.5 (0–1.0) 2.4 (2.1–2.6) In treatment0.4 (0–0.8) 1.0 (0.8–1.3) 1.4 (1.2–1.6) Posttreatment2.1 (1.7–2.5) 1.3 (0.9–1.8) 3.4 (3.2–3.7)

How precise are the estimates of likelihood? The confidence intervals were narrow.

How Can I Apply the Results to Patient Care? Were the study patients and their management similar to those in my practice? Was follow-up sufficiently long? Can I use the results in the management of patients in my practice?

Were the study patients similar to those in my practice? The inclusion criteria were broad. The demographics of this Norwegian study were similar to those of patients with opioid dependence in the United States.

Was follow-up sufficiently long? Yes. The follow-up period ranged from 0 to 7 years. The median (SD) number of days of follow-up time was… –pretreatment: 169 (359) –in treatment: 614 (532) –posttreatment: 349 (392)

Can I use the results in the management of patients in my practice? Yes. The essential finding was that OMT decreased mortality in patients with opioid dependence.