Journal Club Alcohol, Other Drugs, and Health: Current Evidence January–February 2010

Featured Article Randomized Controlled Trial of Proactive Web-Based Alcohol Screening and Brief Intervention for University Students Kypri K, et al. Arch Intern Med. 2009;169(16):1508–1514.

Study Objective To assess the effectiveness of a Web-based alcohol screening and brief intervention program among college students.

Study Design Two-arm parallel randomized controlled trial. Australian college students age 17–24 years (N=13000) were invited by letter and follow-up to complete the Alcohol Use Disorders Identification Test (AUDIT) online. Of 7237 respondents, 2435 scored positive for hazardous/ harmful drinking (AUDIT score ≥8) and were randomized to either: –10 minutes of Web-based motivational assessment and personalized feedback, or –screening only. Follow-up was at 1 and 6 months. Eighty-four percent of participants completed at least 1 online follow-up assess- ment.

Study Design (cont’d) Primary outcome measures were: –frequency of drinking (range, 0–28 days). –number of standard drinks per drinking occasion. –average weekly alcohol consumption. Secondary outcome measures were: –prevalence of binge drinking (consuming 4 standard drinks per drinking occasion for women and 6 for men in the last 4 weeks). –prevalence of heavy drinking (consuming >14 standard drinks for women and >28 for men in the last 4 weeks).

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. –Participants were randomly assigned by Web server software to either the control group (screening only) or to the intervention group.

Was randomization concealed? Yes. –Participants were blind to the true nature of the study, which was presented as a series of surveys. – Researchers were blind to group assignments.

Were patients analyzed in the groups to which they were randomized? Yes. –Participants were analyzed in the group to which they were randomized (intention to treat).

Were the patients in the treatment and control groups similar? Yes. –Demographic characteristics and reported alcohol use were similar between the 2 groups at baseline.

Were patients aware of group allocation? No. –Patients were not aware of group allocation.

Were clinicians aware of group allocation? No. –Clinicians were not aware of group allocation.

Were outcome assessors aware of group allocation? No. –Outcomes were analyzed by computer software.

Was follow-up complete? No. –Follow-up data were obtained from 962 participants in the intervention group (77%) and 942 patients in the control group (80%) at 1 month. –Follow-up data were obtained from 811 participants in the intervention group (65%) and 767 participants in the control group (65%) 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? At 1 month, compared with controls, intervention participants reported: –lower frequency of drinking (rate ratio [RR], 0.89; 95% CI, 0.83– 0.94). –fewer drinks per occasion (RR, 0.93; 95% CI, 0.88–0.98). –lower total alcohol consumption (RR, 0.83; 95% CI, 0.78–0.90). At 6 months, compared with controls, intervention participants reported: –lower frequency of drinking (RR, 0.91; 95% CI, 0.85–0.97). –no difference in drinks per occasion (RR, 0.96; 95% CI, 0.91–1.02). –lower total consumption (RR, 0.89; 95% CI, 0.82–0.96).

How large was the treatment effect? (cont’d) Compared with controls, intervention participants reported: –large significant reductions in heavy drinking at 1 month (RR, 0.50; 95% CI, ) and 6 months (RR, 0.55; 95% CI, ). Participants in the intervention group reported less binge drinking at both follow-up assessments, but the differences were not statistically significant.

How precise was the estimate of the treatment effect? The confidence intervals were narrow for the observed effects.

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? All patients were Australian undergraduate students age 17–24. Fifty-five percent were men. Sixty-five percent lived with a parent or guardian.

Were all clinically important outcomes considered? Yes. – A variety of cogent drinking outcomes were assessed.

Are the likely treatment benefits worth the potential harm and costs? Potential harms and costs were not assessed in this study.