Top POEMs of 2013: Screening and Prevention

Flu, Vaccine Reduces Risk of Adverse CV Events in High-Risk Patients

Clinical question: Does the influenza vaccine lower the risk of major adverse cardiovascular events in adults with coronary disease?

Bottom line: This meta-analysis found that the influenza vaccine is associated with a significantly lower risk of major adverse cardiovascular events in adults with coronary disease. The benefit of influenza vaccination is strongest in adults with a history of recent acute coronary syndrome within the previous 6 months (number needed to treat [NNT] = 8). (LOE = 1a)

Reference: Udell JA, Zawi R, Bhatt DL, et al. Association between influenza vaccination and cardiovascular outcomes in high-risk patients. A meta-analysis. JAMA 2013;310(16):1711-1720.

Study design: Meta-analysis (randomized controlled trials)

Funding source: Government

Setting: Various (meta-analysis)

Synopsis: These investigators searched multiple sources including MEDLINE, EMBASE, the Cochrane Register, reference lists of eligible articles,, and conference abstracts without language restrictions for all published and unpublished randomized clinical trials comparing influenza vaccination with placebo or standard care. Two investigators independently reviewed potential studies for inclusion and methodologic quality using standard scoring tools. Disagreements were resolved by consensus. Six randomized controlled trials met inclusion criteria for the final meta-analysis. These trials (n = 6735) compared influenza vaccine with placebo or control for a mean duration of 7.9 months. The primary outcome measured was a composite of major adverse cardiovascular events, including cardiovascular death or hospitalization for myocardial infarction, unstable angina, stroke, heart failure, or urgent coronary bypass surgery. In the analysis of the 6 included trials, significantly fewer vaccinated patients developed a major adverse cardiovascular event compared with placebo or control patients (2.9% vs 4.7%, respectively; NNT = 58 95% CI, 38-124). The benefit of vaccination was strongest in the subset of patients with a history of recent acute coronary syndrome within the previous 6 months (10.25% with vaccine vs 23.1% with placebo or control; NNT = 8; 6-13). There was, however, no significant difference in all-cause mortality between the vaccinated and placebo or control patient groups. Formal statistical analyses found no evidence of significant heterogeneity among the trials or publication bias.

David Slawson, MD
Director of Information Sciences
University of Virginia Health System
Charlottesville, VA

Screening for Type 2 DM: 10-Year Mortality Not Improved (ADDITION-Cambridge)

Clinical question: Are high-risk patients who are screened for diabetes better off than patients who are diagnosed though the usual means?

Bottom line: Screening high-risk patients for diabetes provides no 10-year mortality benefit. The findings of this study are consistent with those of another large study of screening for type 2 diabetes ( Perhaps it is time to stop screening patients for diabetes and use our limited resources on endeavors that make a difference, like smoking cessation. (LOE = 1b)

Reference: Simmons RK, Echouffo-Tcheugui JB, Sharp SJ, et al. Screening for type 2 diabetes and population mortality over 10 years (ADDITION-Cambridge): a cluster-randomised controlled trial. Lancet 2012;380(9855):1741-1748.

Study design: Other

Funding source: Foundation

Allocation: Uncertain

Setting: Outpatient (primary care)

Synopsis: These British researchers conducted a cluster randomized trial of screening for type 2 diabetes. Fifteen general practices were to screen and intensively treat adults for diabetes, 13 practices were to screen and manage patients according to national guidelines, and 5 practices were left to their own devices. One practice dropped out before screening commenced. Overall, more than 20,000 high-risk adults, aged between 40 years and 69 years, were included and followed up for an average of 10 years. The authors used national databases to determine if any of the patients had died during the study period. Among the screening practices, 94% of potentially eligible patients were invited to be screened, 75% participated, and 3% were found to have diabetes. The overall death rate in the screened patients was 10.5 (per 1000 person-years) compared with 9.9 in unscreened patients. Additionally, there was no difference in cardiovascular deaths (3.3 and 3.2, respectively) or cancer-related deaths (4.8 and 4.4, respectively).

Henry C. Barry, MD, MS
Michigan State University
East Lansing, MI

Repeat BMD Testing: Little, If Any, Value in Elderly Men and Women

Clinical question: Is there any clinical benefit to a repeat bone mineral density screening test after an initial baseline screen in elderly men and women?

Bottom line: This study found little, if any, additional benefit to repeat bone mineral density (BMD) screening at 4 years beyond baseline BMD testing in elderly men and women. A recent similar study (Gourlay ML, et al. NEJM 2012;366(3):225-33) recommended a baseline examination at age 65 with repeat testing necessary only after 15 years in patients with mild osteopenia and after 5 years in patients with moderate osteopenia. It looks like we should be doing a lot fewer DEXA scans than we've been doing. (LOE = 1b)

Reference: Berry SD, Samelson EJ, Pencina MJ, et al. Repeat bone mineral density screening and prediction of hip and major osteoporotic fracture. JAMA 2013;310(12):1256-1262.

Study design: Cohort (prospective)

Funding source: Government

Setting: Population-based

Synopsis: These investigators analyzed data obtained from consenting adult participants of the ongoing Framingham cohort invited to have 3 BMD tests each approximately 4 years apart starting in 1987. Study participants (310 men and 492 women; mean age = 74.8 years) included those who had at least 2 BMD measures with a mean time between each of 3.7 years. Follow-up occurred for participants until death or through 2009 or 12 years after the second BMD. Individuals assessing medical records confirmed self-reported hip fractures, but no other major osteoporotic fractures, including spine, forearm, or shoulder. During a mean follow-up of 9.6 years, 1 or more major osteoporotic fracture occurred in 113 (14%) patients. Prediction modeling for hip or major osteoporotic fracture based on baseline BMD performed significantly better than models based on BMD change. Furthermore, adding BMD change as a variable to models using baseline BMD did not significantly improve prediction performance. Overall, the net change in the percentage of patients with a hip fracture reclassified with a second BMD as being at high risk was not significant (3.9%; 95% CI, -2.2% to 9.9%). Likewise, the net change in the percentage of patients without hip fracture reclassified as low risk by a second BMD was also not significant (-2.2%; 95% CI, -4.5% to 0.1%).

David Slawson, MD
Director of Information Sciences
University of Virginia Health System
Charlottesville, VA

Colonoscopy and Flex Sig Associated with Lower CRC Mortality

Clinical question: Are sigmoidoscopy and colonoscopy associated with a decreased likelihood of death due to colorectal cancer?

Bottom line: This study found a significant reduction in the number of colorectal cancers (CRCs) and CRC-related mortality in persons who chose to undergo flexible sigmoidoscopy or colonoscopy. This may overestimate the benefit, because of unmeasured confounding (things associated with the decision to have colonoscopy that are also associated with CRC mortality). (LOE = 1b)

Reference: Nishihara R, Wu K, Lochhead P, et al. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N Engl J Med 2013;369(12):1095-1105.

Study design: Cohort (prospective)

Funding source: Government

Setting: Population-based

Synopsis: To date, there have been no randomized trials of screening colonoscopy. These researchers used observational data from the Nurse's Health Study and the Health Professionals Follow-up Study, 2 large prospective cohort trials that has followed women since 1976 and men since 1986, respectively. From 1988 through 2008, participants were asked whether they had undergone screening flexible sigmoidoscopy or colonoscopy. The authors reviewed the medical records and pathology reports of those who reported endoscopy to confirm the presence of polyps or CRC. The National Death Index was used to identify deaths due to any cause and deaths due to CRC. Persons undergoing colonoscopy were similar to those who chose not to have colonoscopy regarding the use of aspirin, multivitamins, alcohol, exercise, and red meat intake. Those who had no lower endoscopy were somewhat younger and were less likely to have a family history of CRC. The analysis adjusted for all of these variables when calculating multivariate hazard ratios for the primary outcomes. The likelihood of dying of CRC was lower among persons who had ever had flexible sigmoidoscopy (adjusted hazard ration [aHR] = 0.59; 95% CI, 0.45 - 0.76) and even lower among those who had ever undergone colonoscopy (aHR = 0.32; 0.24 - 0.45). Colonoscopy reduced the likelihood of death due to both proximal and distal cancers, whereas flexible sigmoidoscopy only reduced the likelihood of distal CRC mortality. The benefit was similar for men and women.

Mark H. Ebell, MD, MS
Associate Professor
University of Georgia
Athens, GA

Smokers Who Quit Smoking Become Less Anxious

Clinical question: Does smoking cessation increase anxiety in smokers?

Bottom line: The commonly held belief that smoking is a stress reliever -- and, therefore, quitting increases anxiety -- was not demonstrated in this study. Smokers who were able to quit had a significant reduction in average anxiety scores, whereas smokers who relapsed had increased scores. Perhaps those who are successful in quitting are able to develop skills for managing anxiety. (LOE = 2b)

Reference: McDermott MS, Marteau TM, Hollands GJ, Hankins M, Aveyard P. Change in anxiety following successful and unsuccessful attempts at smoking cessation: cohort study. Br J Psychiatry 2013;202(1):62-67.

Study design: Cohort (prospective)

Funding source: Government

Setting: Outpatient (primary care)

Synopsis: In this cohort study, researchers evaluated anxiety in 491 patients who received behavioral support, education, and nicotine replacement as aids to quit smoking. Patients who wished to quit were recruited from primary care practices. Approximately 18% of patients reported they smoked primarily "to cope," whereas approximately 22% reported smoking primarily "for pleasure," and the rest reported "both" as their motivations. Anxiety was measured using the Spielberger State-Trait Anxiety Inventory (STAI-6). Smoking status was determined based on self-report and biochemical validation. Sustained abstinence occurred in 14% of patients. Anxiety scores 6 months after starting smoking cessation therapy were 11.8 points lower in patients who quit smoking as compared with those who relapsed on a 60-point scale. At the start of the study, 14.7% of patients who eventually would quit were designated as having "high anxiety," and this percentage decreased to 10.3% after 6 months. In the patients who would relapse, 23.7% were highly anxious at the start and this percentage would increase to 31.0% at the end of the study (P = .009).

Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, MA

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