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

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.

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 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.

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?

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. –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.

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.”

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

Were the patients in the treatment and control groups similar? A: Yes. B: Yes.

Were patients aware of group allocation? A: Yes. B: Yes.

Were clinicians aware of group allocation? A: Yes. B: Yes.

Were outcome assessors aware of group allocation? A: No. B: No.

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

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? 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.

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? –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.

Were all clinically important outcomes considered? A: Yes. B: Yes.

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.