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Journal Club

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

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Journal Club

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

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

  6. 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? www.aodhealth.org

  7. 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? www.aodhealth.org

  8. 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). www.aodhealth.org

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

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

  11. 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. www.aodhealth.org

  12. 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. www.aodhealth.org

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

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

  15. 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). www.aodhealth.org

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

  17. 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). www.aodhealth.org 17

  18. 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). www.aodhealth.org

  19. 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? www.aodhealth.org

  20. 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 www.aodhealth.org

  21. 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. www.aodhealth.org

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

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