Journal Club Alcohol, Other Drugs, and Health: Current Evidence March–April 2009

Featured Article Randomized Controlled Trial of a Brief Intervention for Problematic Prescription Drug Use in Non-Treatment-Seeking Patients Zahradnik A, et al. Addiction. 2009;104(1):109–117.

Study Objective To determine whether brief intervention delivered in general hospitals 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 a general and university hospital in Germany. Inclusion criteria: –Consumption of prescription drugs (PD) with addiction potential (>60 days within the last 3 months); 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.

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 the basis of intention-to-treat.

Were the patients in the treatment and control groups similar? Yes. –Groups were similar on most 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.

Was follow-up complete? Eight patients in the control group (n=70) did not complete follow-up: –1 had died. –3 were too ill to answer questions. –4 could not be contacted. One patient in the intervention group (n=56) did not complete follow-up: –he or she 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? All participants CGIGp value Effect size Difference in defined daily dosage* (SD**) 0.26 (2.1)0.12 (1.4)0.42 (2.7) Discontinued use (%) 16 (12.7)6 (8.6)10 (17.9) Reduced use by >25% (%) 50 (39.7)21 (30)29 (51.8)0.02†0.45 *Follow-up minus baseline; **standard deviation; †significant (p<0.05). Differences in Control Group (CG) and Intervention Group (IG) Prescription Drug use at 3-Month Follow-up

How precise was the estimate of the treatment effect? The primary hypothesis—that the discontinuation rate would be greater in the intervention group— was not confirmed. No confidence intervals around the proportion of subjects with >25% reduction in dose were provided.

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 took place 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? This is not clear due to the lack of information about the prescribed medications, their indications, and patients’ subjective experiences.