1. Journal Club Alcohol, Other Drugs, and Health: Current Evidence November–December 2014

2. Featured Articles A. A. Brief intervention for problem drug use in safety-net primary care settings B. B. Screening and brief intervention for drug use in primary care: the ASPIRE randomized clinical trial A: A: Roy-Byrne P, et al. JAMA. 2014;312(5):492–501. B: B: Saitz, et al. JAMA. 2014;312(5):502–513.

3. www.aodhealth.org3 Study Objectives A:A: To determine whether a single-session brief intervention (BI) decreases unhealthy drug use, compared with no BI. B:B: To determine whether 2 kinds of BI decrease unhealthy drug use (a brief negotiated interview [BI] or a modified motivational interview [MOTIV]), compared with no BI.

4. 4 Study Designs A:A: 2-arm randomized clinical trial of 868 patients with drug use on screening. The intervention group received a single motivational interview from a clinic social worker, a 10- minute telephone booster 2 weeks later, an illustrated handout indicating their score on the drug screen, and a list of substance use resources. The comparison group received just the handout and resource list. –Follow-up was at 3, 6, 9, and 12 months. B:B: Randomized clinical trial of 528 adults who screened positive for unhealthy drug use. Randomization was to 1 of 3 conditions: a 10–15 minute structured brief negotiated interview (BI) with a health educator, a 30–40 minute motivational interview plus a 20–30-minute booster session, or no BI. –Follow-up was at 1.5 and 6 months. www.aodhealth.org

5. 5 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. –A: –A: 1:1 randomization using permuted blocks stratified by clinic and by 3 factors known to affect outcome: drug use severity, comorbid mental illness, and readiness to change. –B: –B: 1:1:1 randomization using secure website using random permuted blocks of size 3 and 6 stratified by drug dependence and main drug used.

9. www.aodhealth.org9 Was randomization concealed? –A: –A: Group “allocation was concealed in sequentially numbered opaque envelopes opened by the research assistant at randomization.” –B: –B: Patients were randomized by “data coordinating center.”

10. www.aodhealth.org10 Were patients analyzed in the groups to which they were randomized? A: Yes. B: Yes.

11. www.aodhealth.org11 Were the patients in the treatment and control groups similar? A: Yes. B: Yes.

12. www.aodhealth.org12 Were patients aware of group allocation? A: Yes. B: Yes.

13. www.aodhealth.org13 Were clinicians aware of group allocation? A: Yes. B: Yes.

14. www.aodhealth.org14 Were outcome assessors aware of group allocation? A: No. B: No.

15. www.aodhealth.org15 Was follow-up complete? A:A: Follow-up was >87% at all points. B:B: Follow-up was 98% at 6 months.

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? A:A: Only 47% of the intervention group could be reached for the booster call. –No differences were found between the groups in the number of days in a month for use of the primary drug, even when adjusted for baseline drug use severity, psychiatric comorbidity, or motivation to change. –No effects were found on drug use severity; medical, psychiatric, employment, social, or legal consequences; acceptance of referral to chemical dependency treatment; or medical care use. Arrests and deaths also did not differ between groups. B:B: Only 31% of participants in the MI arm received the booster session. –No differences were found between the groups in the number of days in a month for use of the primary drug, even when stratified by primary drug and risk of drug dependence, or as detected by hair analysis. –No effects were found on drug use consequences; injection drug use; unsafe sex; health care utilization (hospitalizations and emergency department visits, overall or for substance use or mental health reasons); or mutual help group attendance. –Drug use remained high (>90%) in all groups and did not decrease over 6 months.

18. www.aodhealth.org18 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?

19. www.aodhealth.org19 Were the study patients similar to those in my practice? –A: –A: The mean age was 48 years in both groups. Participants were 30% female, 45% white, and 30% were homeless. –B: –B: The mean age was 41 years in all 3 groups. Participants were 30% female, 20% white, and 70% were a high school graduate or equivalent.

20. www.aodhealth.org20 Were all clinically important outcomes considered? A: Yes. B: Yes.

21. www.aodhealth.org21 Are the likely treatment benefits worth the potential harm and costs? A: No benefits were demonstrated and costs were not reported. B: No benefits were demonstrated and costs were not reported.