Journal Club Alcohol, Other Drugs, and Health: Current Evidence November–December 2009

Featured Article Brief intervention in general hospital for problematic prescription drug use: 12-month outcome Otto C, et al. Drug Alcohol Depend. 2009;105(3):221–226.

Study Objective To determine whether brief intervention delivered in the general hospital setting promotes discontinuation or reduction of problematic prescription drug use.

Study Design Randomized controlled trial of 126 patients admitted to the internal, surgical, or gynecological ward of either a general or university hospital in Germany. Inclusion criteria: –Consumption of prescription drugs (PD) with addiction potential (>60 days in the 3 months prior to baseline assessment); or –DSM criteria for PD abuse or dependence. Participants were randomly allocated to either: –2 motivational-interviewing (MI) sessions (intervention); or –receipt of a booklet about PD generally (control). Outcomes measured were >25% reduction or discontinuation of daily PD intake at 12 months.

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

Are the Results Valid? Were patients randomized? Was randomization concealed? Were patients analyzed in the groups to which they were randomized? Were patients in the treatment and control groups similar with respect to known prognostic variables?

Are the Results Valid? (cont‘d) Were patients aware of group allocation? Were clinicians aware of group allocation? Were outcome assessors aware of group allocation? Was follow-up complete?

Were patients randomized? Yes. –Patients were randomized by ward.

Was randomization concealed? Unknown. –Data on the method of randomization are not provided.

Were patients analyzed in the groups to which they were randomized? Yes. –Outcome measures were analyzed on an intent-to-treat basis.

Were the patients in the treatment and control groups similar? Yes. –Groups were similar on demographic and clinical variables. –PD dependence was less common in the control group (35.7%) compared with the intervention group (53.6%) (p=0.049).

Were patients aware of group allocation? Yes. –Patients were aware of group allocation.

Were clinicians aware of group allocation? Yes. –Clinicians were aware of group allocation.

Were outcome assessors aware of group allocation? No. –Follow-up interviews were conducted by staff who had no prior contact with the patient. * *Information from a prior published report of 3-month outcomes: Zahradnik A, et al. Randomized controlled trial of a brief intervention for problematic prescription drug use in non-treatment-seeking patients. Addiction. 2009;104(1):109–117.

Was follow-up complete? Eight patients in the control group (n=70) did not complete follow-up: –2 had died. –2 refused to participate. –4 could not be contacted. Six patients in the intervention group (n=56) did not complete follow-up: –4 had died. –2 could not be contacted.

What Are the Results? How large was the treatment effect? How precise was the estimate of the treatment effect?

How large was the treatment effect? How precise was the estimate of the treatment effect? rbrb ORCIp value Effect on PD cessation Intervention PD dependence Duration of intake −0.537 − – – – Effect on reduction of use Intervention PD dependence Duration of intake – – – r b =regression coefficient; OR=odds ratio; CI=95% confidence interval. Main outcomes at 12 months controlling for significant group differences in PD dependence and duration of intake

How Can I Apply the Results to Patient Care? Were the study patients similar to the patients in my practice? Were all clinically important outcomes considered? Are the likely treatment benefits worth the potential harm and costs?

Were the study patients similar to those in my practice? Of the final sample, –61.9% were women. –mean age was 55 years (range, 30–69 years, with 69% age 50 or older). –more than half were married (56.4%). –the majority were retired (69.1%). The study was conducted in Germany. No data on race/ethnicity are provided.

Were all clinically important outcomes considered? No information was provided about the indications for the use of the medications with “addictive potential.” It is possible that some patients received these medications for pain, anxiety, or insomnia. Subjective outcomes from the patients were not reported.

Are the likely treatment benefits worth the potential harm and costs? Benefits were noted at 3 months in an earlier publication but not at 12 months in the current publication.