1. www.aodhealth.org1 Journal Club Alcohol, Other Drugs, and Health: Current Evidence March–April 2009

2. www.aodhealth.org2 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.

3. www.aodhealth.org3 Study Objective To determine whether brief intervention delivered in general hospitals promotes discontinuation or reduction of problematic prescription drug use.

4. www.aodhealth.org4 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.

5. www.aodhealth.org5 Assessing Validity of an Article about Therapy Are the results valid? What are the results? How can I apply the results to patient care?

6. www.aodhealth.org6 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?

7. www.aodhealth.org7 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?

8. www.aodhealth.org8 Were patients randomized? Yes. –Patients were randomized by ward.

9. www.aodhealth.org9 Was randomization concealed? Unknown. –Data on the method of randomization are not provided.

10. www.aodhealth.org10 Were patients analyzed in the groups to which they were randomized? Yes –Outcome measures were analyzed on the basis of intention-to-treat.

11. www.aodhealth.org11 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).

12. www.aodhealth.org12 Were patients aware of group allocation? Yes. –Patients were aware of group allocation.

13. www.aodhealth.org13 Were clinicians aware of group allocation? Yes. –Clinicians were aware of group allocation.

14. www.aodhealth.org14 Were outcome assessors aware of group allocation? No. –Follow-up interviews were conducted by staff who had no prior contact with the patient.

15. www.aodhealth.org15 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.

16. www.aodhealth.org16 What Are the Results? How large was the treatment effect? How precise was the estimate of the treatment effect?

17. www.aodhealth.org17 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)0.080.14 Discontinued use (%) 16 (12.7)6 (8.6)10 (17.9)0.170.28 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

18. www.aodhealth.org18 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.

19. www.aodhealth.org19 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?

20. www.aodhealth.org20 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.

21. www.aodhealth.org21 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.

22. www.aodhealth.org22 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.