What is the best duration of nicotine replacement therapy in patients who also receive extensive counseling?
In motivated smokers who receive ongoing telephone counseling, extended nicotine replacement beyond 8 weeks does little, on average, to increase cessation rates. Advise patients that they may follow the standard 8-week protocol for nicotine patches or continue to use the patch for longer than 8 weeks, if they so desire. (LOE = 1b)(www.essentialevidenceplus.com)
Schnoll RA, Goelz PM, Veluz-Wilkins A, et al. Long-term nicotine replacement therapy: a randomized clinical trial. JAMA Intern Med 2015;175(4):504-511.
Study design: Randomized controlled trial (nonblinded)
Funding source: Government
Setting: Outpatient (any)
These investigators enrolled 525 smokers who responded to advertisements for a smoking cessation study. All participants received 12 counseling sessions, beginning with an in-person session 2 weeks before their quit date and continuing via telephone over the course of the next year. All patients received nicotine replacement via patch, randomized (allocation concealment uncertain) to a duration of 8, 24, or 52 weeks. Using intention-to-treat analysis, at 6 months 21.7% to 27.2% of patients were abstinent (as confirmed by expired carbon monoxide levels). By one year, abstinence rates were still greater than 20% in all 3 groups with no additional benefit to ongoing treatment.
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Does exercise training, vitamin D, or the combination of both, decrease the number of falls in older women?
Group exercise sessions twice a week for the first year and once a week for the second year, did not decrease the number of falls among older women but halved the likelihood of a fall resulting in an injury. Vitamin D was ineffective. (LOE = 1b-)(www.essentialevidenceplus.com)
Uusi-Rasi K, Patil R, Karinkanta S, et al. Exercise and vitamin D in fall prevention among older women: A randomized clinical trial. JAMA Intern Med. 2015;175(5):703-711.
Study design: Randomized controlled trial (single-blinded)
These Finnish investigators enrolled 409 home-dwelling women 70 to 80 years old with at least 1 fall during the previous year who were not taking vitamin D supplements. The women were randomly assigned (concealed allocation unknown), to a group receiving 800 IU vitamin D per day, twice-weekly group exercise classes, both vitamin D and exercise, or placebo vitamin D and no exercise. All participants kept logs recording any falls. Exercise improved measures of muscle strength, balance, and mobility. Exercise did not improve--and vitamin D worsened--scores on the "timed up and go test," which is a predictor of falls and consists of the time required for a person to rise from sitting from a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down. Using intention-to-treat analysis, the number of falls was not different among the 4 groups over 2 years. However, exercise, with or without vitamin D, halved the number of patients who experienced falls that required medical care, including bruises, sprains, and head injuries (hazard ratio [HR] 0.47; 95% CI .23 - .99 for exercise alone and HR .38; .17-.83 for vitamin D and exercise together). A recent Cochrane review has also shown a decrease in falls with group exercise.
Are men who are invited to receive systematic prostate cancer screening better off than men who receive routine care?
One would have to screen approximately 800 men to prevent one from dying of prostate cancer. However, this result belies the fact that screening for prostate cancer has absolutely no effect on all-cause mortality. We have repeatedly pointed out over the years that cause-specific mortality, often a biased estimate, is disease-oriented evidence, while all-cause mortality is the true patient-oriented outcome. Even the authors concur that their data don't lend support for population-based screening. (LOE = 1b)(www.essentialevidenceplus.com)
Schröder FH, Hugosson J, Roobol MJ, et al, for the ERSPC Investigators. Screening and prostate cancer mortality: results of the European Randomised Study of Screening for Prostate Cancer (ERSPC) at 13 years of follow-up. Lancet 2014;384(9959):2027-2035.
These authors present 13-year follow-up data from the European Randomised study of Screening for Prostate Cancer (ERSPC) in which they randomized men aged between 50 years and 74 years from a population registry to be screened with prostate-specific antigen (PSA) every 4 years or to no screening. Men whose PSA was higher than 3.0 ng/mL underwent biopsies. The authors used local death committees to independently determine cause of death in all men given a diagnosis of prostate cancer and those whose death certificates listed prostate cancer as the cause of death. If the local death committee could not reach a consensus, the case was referred to an international death committee who classified men as having definitely or probably died from prostate cancer. The overall death rate was the same in each group (21%; 19 per 1000 person-years), yet the authors don't mention this in the abstract. To be clear, the authors explicitly state that they didn't expect any effect on all-cause mortality and didn't really care about this other than as a way to determine if the groups were comparable. The total mortality rate massively overwhelms the rate of deaths attributed to prostate cancer among the men in both the intervention and control groups (0.5% and 0.6%, respectively) over the 13 years of follow-up. The authors don't report on the quality of life among the study participants.
Henry C. Barry, MD, MS
Michigan State University
East Lansing, MI
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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Top 20 POEMs of 2015
Screening and Prevention