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Journal Club Alcohol, Other Drugs, and Health: Current Evidence January–February 2011 www.aodhealth.org 1 Featured Article Primary Care-based Intervention to Reduce At-Risk Drinking in Older Adults: A Randomized Controlled Trial Moore AA, et al. Addiction. 2011;106(1):111–120. www.aodhealth.org 2 Study Objective • To examine whether a multifaceted intervention among older patients reduced at-risk drinking and alcohol consumption. www.aodhealth.org 3 Study Design • Randomized controlled trial conducted at 3 primary-care sites in southern California. • Participants: – 631 adults aged ≥55 years recruited over 3 years from participating primary-care provider (PCP) patient schedules. – Identified as at-risk drinkers via telephone-administered Comorbidity Alcohol Risk Evaluation Tool (CARET).* • Participants received either a booklet on healthy behaviors (controls) or an intervention. *Validated measure to identify at-risk drinking in older adults by assessing amount of alcohol use, comorbid conditions, symptoms, and medications. www.aodhealth.org 4 Study Design (cont’d) • Intervention: – – – – – advice from the primary-care provider. a personalized report. a booklet on alcohol and aging. a drinking diary. telephone counseling from a health educator at 2, 4, and 8 weeks. • Primary outcome: – the proportion of participants meeting at-risk drinking criteria at 3 and 12 months. • Secondary outcomes: – number of drinks in past 7 days. – heavy drinking (≥4 or more drinks in a day) in the past 7 days. – CARET score. www.aodhealth.org 5 Study Design (cont’d) • Eligibility criteria: – age ≥55 years. – English or Spanish speaker. – consumed at least 1 alcoholic drink in the past week. – able to hear the screening questions. – healthy enough to participate. – not treated for an alcohol use disorder in the prior 3 months. www.aodhealth.org 6 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 7 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 8 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 9 Were patients randomized? • Yes. www.aodhealth.org 10 Was randomization concealed? • Yes. – Groups were assigned by computer-generated random numbers. www.aodhealth.org 11 Were patients analyzed in the groups to which they were randomized? • Yes (intention-to-treat analysis). www.aodhealth.org 12 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. www.aodhealth.org 13 Were patients aware of group allocation? • No. – Participants were blinded to the true nature of the study; they were told it focused on healthy behaviors in older adults, and questions on seatbelt use, exercise, diet, and smoking were included with CARET (alcohol screening) questions. www.aodhealth.org 14 Were clinicians aware of group allocation? • Yes. – Advice from a primary care physician was a component of the intervention. www.aodhealth.org 15 Were outcome assessors aware of group allocation? • No. – Research assistants blinded to treatment allocation conducted all baseline and outcome assessments. www.aodhealth.org 16 Was follow-up complete? • Attrition rates were higher in the intervention group (n=310): – 21% at 3 months. – 29% at 12 months. than in the control group (n=321): – 4% at 3 months. – 7% at 12 months. www.aodhealth.org 17 What Are the Results? • How large was the treatment effect? • How precise was the estimate of the treatment effect? www.aodhealth.org 18 How large was the treatment effect? • At 3 months, relative to controls, participants in the intervention group: – were less likely to be at-risk drinkers (OR,* 0.41; 95% CI* 0.22–0.75). – had lower CARET risk scores (RR,* 0.77; 95% CI, 0.63–0.94). – reported consuming fewer drinks in the past week (RR 0.79; 95% CI, 0.70–0.90). – reported less past-week heavy drinking (OR 0.46; 95% CI, 0.22–0.99). • At 12 months, only fewer drinks per week remained significant (RR, 0.87; 95% CI, 0.76–0.99). *OR=odds ratio; CI=confidence interval; RR=relative risk. www.aodhealth.org 19 How precise was the estimate of the treatment effect? • The sample was large, and confidence intervals were narrow for the observed effects. www.aodhealth.org 20 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 21 Were the study patients similar to those in my practice? • Participants ranged in age from 55 to 89 years. • Seventy-one percent were men, 87% were nonHispanic white, 77% had attended at least some college, and 75% were either married and living with someone. www.aodhealth.org 22 Were all clinically important outcomes considered? • A range of clinically important drinking outcomes were considered. • At-risk drinking is associated with a variety of adverse health consequences. The current study was neither large enough nor long enough to assess the impact of the intervention on outcomes such as mortality, cardiovascular disease, or breast cancer, all of which are increased in at-risk drinkers. www.aodhealth.org 23 Are the likely treatment benefits worth the potential harm and costs? • No harms were identified. • Cost data were not provided. • Prior studies have reported favorable costeffectiveness ratios for brief alcohol interventions. www.aodhealth.org 24