Top POEMs of 2011: Screening and Prevention

Asking About Suicide Doesn't Trigger Suicidal Ideation

Clinical Question: Does asking about suicidal ideation increase a patient's feelings that life is not worth living?

Bottom Line: Asking about suicide -- even asking 6 questions on the topic -- does not increase depressed patients' thoughts that life is not worth living. (Level of Evidence: 2b)

Reference: Crawford MJ, Thana L, Methuen C, et al. Impact of screening for risk of suicide: randomised controlled trial. Br J Psychiatry 2011;198(5):379-384.

Study Design: Randomized controlled trial (single-blinded)

Funding Source: Self-funded or unfunded

Allocation: Unconcealed

Setting: Outpatient (primary care)

Synopsis: These investigators enrolled 443 patients (90% of screened patients) of 4 urban general practices in London who screened positive for depression. The patients were, on average, 48.5 years old, and 69% were women. The patients were randomized (unconcealed randomization) to be asked either about suicidal ideation or about general health and lifestyle via telephone immediately after enrollment.To mask the purpose of the study, the patients were told that the study was a screening for health and emotional problems. The authors asked a total of 6 questions of each group; obviously, in the suicide ideation group, this goes far beyond the typical, "Do you have any thoughts about harming yourself or others?" Follow-up occurred in 79.2% of patients. Analysis was by intention to treat. At follow-up, a similar proportion of patients in both groups answered yes to the question, "On the past two weeks, have you felt your life is not worth living?" (28.0% vs 24.1%, difference not signfiicant). Similar responses to the other questions occurred in both groups. One person in the control group attempted suicide. The study had an 80% power of finding a 50% increase in suicidal ideation if one existed.

ALLEN F. SHAUGHNESSY, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, MA

Varenicline Increases Risk of Adverse CV Events

Clinical Question: Does varenicline increase the risk of serious adverse cardiovascular events?

Bottom Line: Varenicline increased the risk of adverse cardiovascular (CV) events in the participants of 14 clinical trials, despite the fact that these trials typically excluded patients with known heart disease. The authors apply the relative risk of 1.72 to a patient with known heart disease, and estimate a number needed to treat to harm of 28 for patients with heart disease who take vareniciline (95% CI, 13 - 213). This drug should be used with caution in patients with, or at high risk for, CV disease, particularly since there are alternative pharmacologic approaches for these patients. (Level of Evidence: 1b-)

Reference: Singh S, Loke YK, Spangler JG, Furberg CD. Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis. CMAJ 2011;183(12):1359-1366.

Study Design: Meta-analysis (randomized controlled trials)

Funding Source: Government

Setting: Outpatient (any)

Synopsis: Smoking is bad for you, no doubt, so quitting is a good thing. However, previous reports have described an increased risk of adverse CV events among users of varenicline. This systematic review provides the best estimate to date of the extent of that risk. These authors identified all double-blinded, randomized controlled trials that compared varenicline with placebo for smoking cessation and reported at least one adverse CV event or death. They included 14 studies with a total of 8217 patients. Most studies were of high quality, with adequate randomization, allocation concealment, masking, follow-up, and reporting of adverse events. The studies treated patients with varenicline for between 8 and 12 weeks, and then followed up patients for a total of between 24 and 52 weeks. There was no evidence of publication bias (ie, not publishing small studies or those with negative findings). The mean age of patients was approximately 43 years, and the majority were male. The studies were consistent in their results, and the weighted odds ratio of an adverse CV event in patients randomized to receive varenicline was 1.72 (95% CI, 1.1 - 2.7).

MARK H. EBELL, MD, MS
Associate Professor
University of Georgia
Athens, GA

Exercise and Diet Good Even for Frail, Obese Elderly

Clinical Question: Do obese, frail, older patients benefit most from exercise, weight loss, or both?

Bottom Line: A combination of exercise and weight loss will provide the most improvements in physical performance and weight loss in older, obese, frail patients. (Level of Evidence: 1b)

Reference: Villareal DT, Chode S, Parimi N, et al. Weight loss, exercise, or both and physical function in obese older adults. N Engl J Med 2011;364(13):1218-1229.

Study Design: Randomized controlled trial (single-blinded)

Funding Source: Government

Allocation: Uncertain

Setting: Population-based

Synopsis: Well-designed studies of diet and exercise are all too rare. In this trial, the authors identified obese adults older than 65 years who had at least mild to moderate frailty. All were sedentary and had a stable weight. Patients were randomized to 1 of 4 groups: untreated control; weight management only, with a reduction of 500 to 750 calories per day; exercise only, including aerobic exercises, resistance training, and flexibility training; or both exercise and weight management. Of 107 persons originally enrolled in the study, 93 completed it 1 year later. Drop-outs were similar between groups, and groups were balanced at the start of the study (mean age = 70 years). The mean weight of participants was 102 kg, with a bodymass index of 37.1. At the end of 1 year, the weight management and the exercise plus weight management groups had both lost approximately 9 kg, while those in the exercise only and control groups lost fewer than 2 kg. The Physical Performance Test, a 36-point scale measuring physical status, improved more in the diet and exercise group (5.4 points) than in the exercise only (4.0 points), diet only (3.1 points) or control (0.2 points) groups. The differences between the 3 intervention groups and the control group are probably clinically relevant, although the differences between the intervention groups are not.

MARK H. EBELL, MD, MS
Associate Professor
University of Georgia
Athens, GA

POEMs are provided by Essential Evidence Plus, a point-of-care clinical decision support system published by Wiley-Blackwell. For more information, please see http://www.essentialevidenceplus.com(www.essentialevidenceplus.com).

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