Top POEMs of 2016: Miscellaneous

Top 20 POEMs of 2016

Smoking Cessation: Abrupt Quitting More Effective Than a Gradual Approach

Clinical question
Should patients stop smoking abruptly on their quit date or gradually reduce their smoking before attempting smoking cessation?

Bottom line
For motivated patients, quitting abruptly on a set date, preceded by 2 weeks of nicotine replacement via a patch, is more effective than doing the same preparation but gradually cutting down before stopping, even when each omitted cigarette is replaced with a hit of nicotine. All of the patients in this study received extensive behavior support before quitting and during the first few months, which likely added to the success rates in both groups. (LOE = 1b-)(www.essentialevidenceplus.com)

Reference
Lindson-Hawley N, Banting M, West R, Michie S, Shinkins B, Aveyard P. Gradual versus abrupt smoking cessation. A randomized, controlled noninferiority trial. Ann Intern Med 2016;164(9):585-592.

Study design: Randomized controlled trial (nonblinded)

Funding source: Foundation

Allocation: Uncertain

Setting: Outpatient (primary care)

Synopsis
Participants in this study were recruited from 31 general practices in England. The practices sent letters to patients who smoke asking them to participate in a study on quitting. In other words, the 697 patients in this study were interested in quitting. The participants were assigned (allocation concealment unclear) to 2 groups, differing only in the initial approach to cessation. All patients were asked to set a quit day 2 weeks after enrollment and were given nicotine patches (21 mg per day) to use during those 2 weeks. Patients in the "abrupt cessation group" were asked to stop smoking on their quit day. Participants in the "gradual cessation group" were also given short-acting nicotine products (gum, lozenges, nasal spray, sublingual tablets, inhalator, or mouth spray) and asked to reduce smoking to half of the baseline amount by the end of the first week and to a quarter of the baseline amount at the end of the second week. All participants were given extensive behavior support by a research nurse weekly for 2 weeks before their quit day, the day before their quit day, weekly for 4 weeks after quitting, and at 8 weeks after the quit day. At both 1 month and 6 months, validated abstinence rates were higher in the abrupt cessation group: 49.0% vs 39.2% at 1 month (relative risk [RR] 0.80; 95% CI 0.66 to 0.93) and 22.0% vs 15.5% (RR 0.71; 0.46 to 0.91) at 6 months. At 1 month, one additional patient will be successful for every 13 patients who abruptly stop instead of stopping gradually (number needed to treat [NNT] = 12.8; 7.5 - 38.4). At 6 months, the benefit is not quite as large (NNT = 22.2; 11.9 - 71.7). Withdrawal symptoms and urge intensity reports were similar in both groups. The study was set up as a noninferiority trial, but inferiority (less than a 19-percentage-point difference) was not met.

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

Best Approaches to Physical Diagnosis of Acute Red Eye

Clinical question
What signs or symptoms are indicative of serious eye disease in patients with red eye or a bacterial cause in patients with presumed conjunctivitis?

Bottom line
Eliciting photophobia via pupillary constriction and the presence of anisocoria (>1 mm) in patients with an acute red eye are the best predictors of serious eye disease (eg, uveitis, keratitis, corneal abrasion, or scleritis) requiring prompt referral. Lack of morning eye matting is a fairly good way to rule out bacterial conjunctivitis, but no sign or symptom in this study consistently identifies a bacterial cause or response to antibiotic treatment. (LOE = 2a-)(www.essentialevidenceplus.com)

Reference
Narayana S, McGee S. Bedside diagnosis of the 'red eye': A systematic review. Am J Med 2015;128(11):1220-1224.

Study design: Systematic review

Funding source: Self-funded or unfunded

Setting: Various (meta-analysis)

Synopsis
The authors conducted a limited search, using only a single database (PubMed) and only selecting English-language studies that evaluated the diagnostic accuracy of the history and physical examination in adult patients with red eye. They included studies that enrolled patients with either presumed conjunctivitis who had bacterial culture or patients with red eye, all of whom eventually underwent slit-lamp examination. Two authors independently extracted the data. They did not evaluate the quality of the research. In 5 studies of 957 consecutive patients with red eye, the most useful findings that indicated serious eye disease were anisocoria (with the smaller pupil in the red eye and difference between pupil diameters >1 mm; positive likelihood ratio [LR+] = 6.5; 95% CI 2.6 - 16.3) and photophobia, elicited by direct illumination (LR+ = 8.3; 2.7 - 25.9), indirect illumination (LR+ = 28.8; 1.8 - 459), or finger-to-nose test (LR+ = 21.4; 12 - 38.2). In 3 studies of 281 patients enrolled consecutively with presumed conjunctivitis, 45% had positive bacterial cultures. No sign or symptom was particularly effective at identifying bacterial conjunctivitis, either alone or in combination. The lack of morning "glue eye," (LR+ = 0.3; 0.1 - 0.8) or failure to observe a red eye at 20 feet (LR+ = 0.2; 0 - 0.8) may be useful for ruling out a bacterial cause. None of the included studies evaluated the ability of any sign or symptom to predict response to topical antibiotic treatment.

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

Azithromycin Slightly Inferior to Doxycycline for Genital Chlamydia Infection

Clinical question
Is azithromycin noninferior to doxycycline for the treatment of urogenital chlamydia infection?

Bottom line
Azithromycin had a slightly higher failure rate than doxycycline, but this must be balanced against its greater convenience and almost-certainly better adherence in the real world. If you have a male patient with chlamydia whom you judge will be adherent, then doxycycline may be preferable to azithromycin. (LOE = 1b)(www.essentialevidenceplus.com)

Reference
Geisler WM, Uniyal A, Lee JY, et al. Azithromycin versus doxycycline for urogenital Chlamydia trachomatis infection. N Engl J Med 2015;373(26):2512-321.

Study design: Randomized controlled trial (double-blinded)

Funding source: Government

Allocation: Concealed

Setting: Other

Synopsis
The Centers for Disease Control recommends either 1 g azithromycin in a single dose or 100 mg doxycycline twice daily for 7 days to treat urogenital Chlamydia trachomatis infection. Obviously, a single dose may have greater adherence, especially in adolescents and young adults, and previous studies have not been able to ensure compliance. Additionally, some studies have found clinical cure rates of less than 90% with azithromycin. These authors screened for chlamydia males and females aged 12 to 21 years who were incarcerated in a youth correctional facility. Those with a positive screening result (n = 567) were randomized to receive either azithromycin or doxycycline. A large but similar percentage in each group (~ 45%) was withdrawn from the study, mostly because they were discharged from the facility before the test of cure at 28 days could be completed. A total of 155 participants in each group completed the study. There were no treatment failures in the doxycycline group, while there were 7 treatment failures in the azithromycin group (6/102 males and 1/53 females). The 3.2% treatment failure rate just exceeded the prespecified bounds for noninferiority (upper bound of the confidence interval 5.9%, with a 5% noninferiority margin).

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

Third-Generation Oral Contraceptives Associated with Greater Risk of PE, Stroke, and MI

Clinical question
Which oral contraceptive combinations have the highest risk of cardiovascular effects?

Bottom line
Although there is risk with any current oral contraceptive combination, those that contain lower doses of estrogen, and levonorgestrel instead of desogestrel or gestodene, are associated with the least risk of ischemic stroke, myocardial infarction, or pulmonary embolus. These safer products are older, so are often less expensive. This is not the first study to show this difference, but I think its enrollment of 5 million women makes it the largest. (LOE = 2b)(www.essentialevidenceplus.com)

Reference
Weill A, Dalichampt M, Raguideau F, et al. Low dose oestrogen combined oral contraception and risk of pulmonary embolism, stroke, and myocardial infarction in five million French women: cohort study. BMJ 2016;353:i2002.

Study design: Cohort (retrospective)

Funding source: Foundation

Setting: Population-based

Synopsis
This study, conducted in France, used the national health insurance database to identify all women who filled at least one prescription for an oral contraceptive between July 2010 and September 2012. The authors compared these data with the hospital discharge database to identify whether any of these women experienced an admission for pulmonary embolism, cancer, ischemic stroke, or myocardial infarction over the same period. They identified almost 5 million women with a total of 5,443,916 woman-years of oral contraceptive use. The risk of cardiovascular effects was very low: roughly 6 events per 10,000 woman-years, which is similar to other reports. However, the authors found some differences among products: After adjustment for progestogen and risk factors, stroke, pulmonary embolus, and myocardial infarction risk were all statistically lower with lower-dose estrogen (20 mcg vs 30-40 mcg). They also found, after adjustment, that progestogen mattered: desogestrel (in Desogen, Mircette) and gestodene (Gynera, Femoden, and many others) were associated with higher risk of pulmonary embolus than levonorgestrel. Norethisterone (in Loestrin, Microgestin, and others) was associated with lower pulmonary embolus risk. The combination of estrogen 20 mcg and levonorgestrel is associated with the lowest risk. These risks are still small (numbers needed to treat to harm are in the thousands). This study doesn't tell us about products that contain other estrogens or progestogens since these are the only combinations covered by French national health insurance. Also, the database doesn't allow for analysis by smoking status.

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

Parents Should Use an Oral Syringe to Measure and Administer Liquid Medicines

Clinical question
Do parents make more mistakes with certain dosing tools when measuring and administering medications?

Bottom line
In this experimental study - the study was performed in an office setting rather than at home - parents consistently made more dosing errors when using a medicine cup than when using an oral syringe to measure out liquid pediatric medicine. Some of these dosing errors were greater than twice the prescribed dose (5.8% more with the cup). Instruct parents to obtain an oral syringe when prescribing liquid medicine. Warn parents to stay away from tableware to measure medicines, since teaspoons vary quite a bit in their volume. Oh, and don't forget to use the term "milliliter" instead of "cc," since that is how oral syringes are marked. (LOE = 1b-)(www.essentialevidenceplus.com)

Reference
Yin HS, Parker RM, Sanders LM, et al. Liquid medication errors and dosing tools: a randomized controlled experiment. Pediatrics 2016;138(4):e20160357.

Study design: Randomized controlled trial (nonblinded)

Funding source: Government

Allocation: Concealed

Setting: Outpatient (primary care)

Synopsis
The researchers enrolled parents of children 8 years or younger visiting 1 of 3 outpatient pediatricians' offices. The 2110 parents were randomly assigned to 1 of 5 groups (using concealed allocation) and asked to interpret a standard prescription label expressing a dose of amoxicillin in terms of teaspoon (either abbreviated or spelled out) or milliliters (abbreviated as "mL"), or both. They were given 2 oral syringes of different sizes and markings, and a medicine cup with gradations on the size. All participants were asked to measure out 2.5 mL, 5 mL, and 7.5 mL using each instrument. Five groups were needed to randomize the order of measuring tool and the prescription labeling. A total of 84.4% of parents made one or more dosing errors, meaning they overdosed or underdosed by 20% or more, and 21.0% made a error of greater than twice the prescribed dose. Using the cup, 43% of parents made a dosing error in at least 1 of the 3 measurements as compared with 16% to 17% with the syringes (P < .001). More errors were made with cups than with either syringe size (odds ratio = 4.6; 95% CI 4.2 - 5.10). The number of errors was significantly higher when a cup was used instead of a syringe to measure either 2.5 mL or 5.0 mL doses. Errors were greater in parents with lower health literacy. Neither the parents nor the investigator were masked to group assignment, and this experimental study put parents on the spot to measure out the pink stuff in the office and not in the more natural setting of home.

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

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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