Journal Club Alcohol Other Drugs and Health Current
Journal Club Alcohol, Other Drugs, and Health: Current Evidence May-June 2020
Featured Article Alcohol abstinence in drinkers with atrial fibrillation Voskoboinik A, et al. N Engl J Med. 2020; 328: 20– 28.
Study Objectives • To assess the effect of abstinence from alcohol consumption on secondary prevention of atrial fibrillation. www. aodhealth. org 3
Study Design • Population: patients (N=140; 85% male) from 6 tertiary hospitals in Australia with paroxysmal or persistent atrial fibrillation who were drinking an average of 17 standard US drinks per week and were willing to consider abstinence. – Patients with alcohol use disorder were excluded from the trial. • Participants in normal sinus rhythm were randomized to either: – encouragement to abstain from alcohol consumption (with monthly communication to assess adherence and provide positive reinforcement), or – continue their usual alcohol consumption. – Both groups had an initial 2 -week period post-randomization in which outcomes were not measured. – Patients’ cardiac rhythm was monitored continuously for 6 months. www. aodhealth. org 4
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 5
Are the Results Valid? • Were participants randomized? • Was randomization concealed? • Were participants analyzed in the groups to which they were randomized? • Were participants in the intervention and control groups similar? www. aodhealth. org 6
Are the Results Valid? (cont‘d) • Were participants aware of group allocation? • Were outcome assessors aware of group allocation? • Was follow-up complete? www. aodhealth. org 7
Were participants randomized? • Yes, in a 1: 1 ratio via a computerized scheme. www. aodhealth. org 8
Was randomization concealed? • Yes. It was generated with block randomization and sets of randomly selected blocks were provided to the treatment sites. www. aodhealth. org 9
Were participants analyzed in the groups to which they were randomized? • Yes. www. aodhealth. org 10
Were the participants in the intervention and control groups similar? • Yes. – “Baseline clinical characteristics, including atrial fibrillation phenotype and method of rhythm monitoring, were fairly well-balanced between the groups. ” – There were 70 patients in each group. www. aodhealth. org 11
Were participants aware of group allocation? • Yes. www. aodhealth. org 12
Were outcome assessors aware of group allocation? • Investigators were aware of group allocation, but any ECGs suspected to represent atrial fibrillation were reviewed by two cardiologists who were unaware of the group assignments. www. aodhealth. org 13
Was follow-up complete? • Yes. – Of the 140 patients who entered the study, 137 (97. 9%) completed the 6 -month follow -up with complete rhythm data and alcohol history. www. aodhealth. org 14
What Are the Results? • How large was the treatment effect? • How precise was the estimate of the treatment effect? www. aodhealth. org 15
How large and precise was the treatment effect? • After two initial weeks in which outcomes were not assessed, atrial fibrillation recurred in 53% of the abstinence group and 73% of the control group. – The time to recurrence was longer in the abstinence group than in the control group (hazard ratio, 0. 55; 95% CI, 0. 36 to 0. 84). – Median time in atrial fibrillation was 0. 5% and 1. 2%, respectively. • Patients in the abstinence group reduced their alcohol intake from 16. 8± 7. 7 to 2. 1± 3. 7 drinks per week (87. 5% reduction; mean difference, 14. 7; 95% confidence interval [CI], 12. 7 to 16. 7). – 61% achieved abstinence and 76% drank ≤ 2 drinks per week. – In the control group, drinking declined from 16. 4± 6. 9 to 13. 2± 6. 5 drinks per week (19. 5% reduction; mean difference, 3. 2; 95% CI, 1. 9 to 4. 4). www. aodhealth. org 16
How Can I Apply the Results to Patient Care? • Were all clinically important outcomes considered? • Are the likely treatment benefits worth the potential harm and costs? www. aodhealth. org 17
Were all clinically important outcomes considered? • Yes. www. aodhealth. org 18
Are the likely treatment benefits worth the potential harm and costs? • Yes, among people without alcohol use disorder who are willing to abstain from alcohol consumption and can do so safely. • There are no financial burdens associated with this treatment among the appropriate patient population. www. aodhealth. org 19
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