1. Journal Club Alcohol, Other Drugs, and Health: Current Evidence May–June 2013

2. Featured Article Effectiveness of screening and brief alcohol intervention in primary care (SIPS trial): pragmatic cluster randomised controlled trial. Kaner E, et al. BMJ. 2013;346:e8501.

3. www.aodhealth.org3 Study Objective To evaluate the effectiveness of different brief intervention (BI) strategies for reducing hazardous or harmful drinking in primary care.

4. 4 Study Design Pragmatic cluster randomized controlled trial conducted in primary care practices in the north east and south east of England and in London. Population was 3562 patients ≥18 years of age routinely presenting in primary care, of whom 2991 (84%) were eligible. Of these, 900 (30.1%) screened positive for hazardous or harmful drinking and 756 (84%) received a brief intervention (BI). Patients’ harmful drinking status was assessed at baseline, 6 months, and 12 months as measured by the alcohol use disorders identification test (AUDIT). 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. –Practices were randomized to three interventions, each of which was added to the previous one: a patient leaflet control group; five minutes of structured brief advice; 20 minutes of brief lifestyle counseling. –Twenty-four allocations were initially generated for each of the possible factorial combinations of screening approach, screening tool, and intervention. –Randomization was stratified by geographical area (north versus south).

9. www.aodhealth.org9 Was randomization concealed? Yes. –A secure remote randomization service carried out the randomization.

10. www.aodhealth.org10 Were patients analyzed in the groups to which they were randomized? Yes (intention-to-treat analysis).

11. www.aodhealth.org11 Were the patients in the treatment and control groups similar? Unknown. –A demographic profile questionnaire was administered at baseline, however, demographic data broken down by group assignment was not provided. –The average age of the participants overall was 45. Subjects were predominantly male (62%) and white (92%); 32% were current smokers and 34% had attained higher degree level. –Baseline positive AUDIT results were: 25% of the patient leaflet group; 33% of the leaflet and brief advice group; and 33% of the leaflet, brief advice, and brief lifestyle counseling session group.

12. www.aodhealth.org12 Were patients aware of group allocation? Yes. –It was not possible to blind the patients as to whether they were receiving the pamphlet, brief advice, or brief lifestyle counseling session.

13. www.aodhealth.org13 Were clinicians aware of group allocation? Yes. –Clinicians were not blind to group allocation as they were responsible for conducting the interventions.

14. www.aodhealth.org14 Were outcome assessors aware of group allocation? No. –At 6 and 12 months researchers who were blinded to the allocated intervention contacted the participants.

15. www.aodhealth.org15 Was follow-up complete? At 6 months follow-up rates were 85%: Patient information leaflet group 85% (n=212); brief advice 86% (n=215); and brief lifestyle counseling session 85% (n=217). At 12 months follow-up rates were 82%: Patient information leaflet group 79% (n=197); brief advice 83% (n=209); and brief lifestyle counseling 83% (n=211).

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? At 6 months: The odds ratio (OR) of having a negative AUDIT status for brief advice versus the leaflet = 0.85 (95% CI: 0.52 to 1.39). The OR for brief lifestyle counseling versus the leaflet = 0.78 (95% CI: 0.48 to 1.25). The mean difference in AUDIT score between brief advice and the leaflet = 0.06 (95% CI: -0.70 to 0.83). Between brief lifestyle counseling and the leaflet = -0.38 (95% CI: -1.51 to 0.75).

18. www.aodhealth.org18 How large was the treatment effect? (cont’d) At 12 months: The odds ratio of having a negative AUDIT status for brief advice versus the leaflet = 0.91 (95% CI: 0.53 to 1.56). The OR for brief lifestyle counseling versus the leaflet = 0.99 (95% CI: 0.60 to 1.62). The mean difference in AUDIT score between brief advice and the leaflet = -.20 (95% CI: -0.83 to 0.43). Between brief lifestyle counseling and the leaflet = -0.25 (95% CI: -1.19 to 0.68).

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? The study took place in England. Demographics included: –% Male: 62 –% White: 92 –Mean age: 44.5 years Clinical characteristics –Mean AUDIT score: 13 –Never think about drinking less alcohol (%): 26 –Smoker (%): 34

21. www.aodhealth.org21 Were all clinically important outcomes considered? No. The primary outcome was the AUDIT. Alcohol- related problems were also reported. However, detailed results regarding specific alcohol quantities, frequency, or heavy episodic (binge) drinking are not presented.

22. www.aodhealth.org22 Are the likely treatment benefits worth the potential harm and costs? No benefits, harms, or costs were presented.