Cosmetic gynecology-a systematic review and call for standardized outcome measures.

OBJECTIVE: Cosmetic gynecology, a field which has garnered substantial attention over recent years, lacks a universally accepted nomenclature. The aim of this systematic review is to evaluate techniques, outcome measures reported, and adverse events in patients undergoing cosmetic gynecology procedures and offer recommendations to improve reporting metrics. METHODS: A systematic literature search was performed using electronic databases from inception to April 2019. The search was based on 51 unique cosmetic gynecology keywords such as: "labiaplasty," "vaginal rejuvenation," and "liposuction mons pubis." All English full-text prospective and retrospective observational and interventional studies with at least five subjects that describe a cosmetic gynecology procedure were included. Only full-text articles were included. This protocol has been registered with PROSPERO (CRD 42019131860). RESULTS: A total of 1837 articles were identified from the search strategy with 42 included in the quantitative synthesis. Procedures described included: labia minora reduction with or without clitoral hood reduction, labia majora augmentation, surgical vaginal caliber reduction, mons pubis reduction/suspension, and energy-based therapy for vaginal laxity or vulvar laxity. Efficacy and satisfaction metrics were highly variable ranging from validated questionnaires to no outcome subjectively or objectively quantified. Complication rates varied by procedure but were generally low and ranged between Clavien-Dindo grades I-III. CONCLUSIONS: Although there is a breadth of literature on cosmetic gynecology surgical techniques and short-term complication rates, the terminology and outcome measures utilized are heterogeneous. To address this, standardized terminology along with uniform cosmetic and functional endpoints must be developed.

Rapid Emergency Medicine Score (REMS) in the trauma population: a retrospective study.

OBJECTIVE: Rapid Emergency Medicine Score (REMS) is an attenuated version of the Acute Physiology and Chronic Health Evaluation (APACHE) II score and has utility in predicting mortality in non-surgical patients, but has yet to be tested among the trauma population. The objective was to evaluate REMS as a risk stratification tool for predicting in-hospital mortality in traumatically injured patients and to compare REMS accuracy in predicting mortality to existing trauma scores, including the Revised Trauma Score (RTS), Injury Severity Score (ISS) and Shock Index (SI). DESIGN AND SETTING: Retrospective chart review of the trauma registry from an urban academic American College of Surgeons (ACS) level 1 trauma centre. PARTICIPANTS: 3680 patients with trauma aged 14 years and older admitted to the hospital over a 4-year period. Patients transferred from other hospitals were excluded from the study as were those who suffered from burn or drowning-related injuries. Patients with vital sign documentation insufficient to calculate an REMS score were also excluded. PRIMARY OUTCOME MEASURES: The predictive ability of REMS was evaluated using ORs for in-hospital mortality. The discriminate power of REMS, RTS, ISS and SI was compared using the area under the receiver operating characteristic curve. RESULTS: Higher REMS was associated with increased mortality (p<0.0001). An increase of 1 point in the 26-point REMS scale was associated with an OR of 1.51 for in-hospital death (95% CI 1.45 to 1.58). REMS (area under the curve (AUC) 0.91±0.02) was found to be similar to RTS (AUC 0.89±0.04) and superior to ISS (AUC 0.87±0.01) and SI (AUC 0.55±0.31) in predicting in-hospital mortality. CONCLUSIONS: In the trauma population, REMS appears to be a simple, accurate predictor of in-hospital mortality. While REMS performed similarly to RTS in predicting mortality, it did outperform other traditionally used trauma scoring systems, specifically ISS and SI.

Unannounced telephone pill counts for assessing varenicline adherence in a pilot clinical trial.

BACKGROUND: Despite consistent evidence linking smoking cessation pharmacotherapy adherence to better outcomes, knowledge about objective adherence measures is lacking and little attention is given to monitoring pharmacotherapy use in smoking cessation clinical trials. OBJECTIVES: To examine unannounced telephone pill counts as a method for assessing adherence to smoking cessation pharmacotherapy. RESEARCH DESIGN: Secondary data analysis of a randomized pilot study. PARTICIPANTS: 46 moderate-to-heavy (>10 cigarettes per day) African-American smokers. MAIN MEASURES: Smokers received 1 month of varenicline (Pfizer Global Pharmaceuticals, New York, NY) in a pill box at baseline. Unannounced pill counts were completed by telephone 4 days prior to an in-person pill count conducted at Month 1. At both counts, each compartment of the pill box was opened and the number of remaining pills was recorded. RESULTS: Participants were a mean age of 48 years (SD = 13), predominately female (59%), low income (60% < $1800 monthly family income), and smoked an average of 17 (SD = 7) cigarettes per day. A high degree of concordance was observed between the number of pills counted by phone and in-person (r(s) = 0.94, P < 0.001). Participants with discordant counts (n = 7) had lower varenicline adherence (mean [SD] = 77% [18%] vs 95% [9%], P < 0.0005), but reported better medication adherence in the past (1.0 [0.8] vs 2.8 [1.0], P < 0.0004) than participants with matching phone and in-person counts (n = 39). CONCLUSION: Unannounced telephone pill counts appear to be a reliable and practical method for measuring adherence to smoking cessation pharmacotherapy.

A pilot clinical trial of varenicline for smoking cessation in black smokers.

INTRODUCTION: Varenicline, a first-line non-nicotine medication, has not been evaluated in Black smokers, and limited attention has been paid to pharmacotherapy adherence in smoking cessation trials. This pilot study estimated quit rates for Black smokers treated with varenicline and tested a behavioral intervention to aid varenicline adherence. METHODS: Seventy-two Black smokers (>10 cigarettes per day; cpd) were randomly assigned to adherence support (AS; n = 36) or standard care (n = 36). All participants received 3 months of varenicline and a single counseling session focused on making a quit plan. AS participants received 5 additional counseling sessions to encourage medication use. Outcome measures included salivary cotinine, and carbon monoxide confirmed smoking abstinence, reductions in self-reported cpd, and pill counts of varenicline adherence at Months 1, 2, and 3. RESULTS: Sixty-one participants (84.7%) completed follow-up at Month 3. Participants were female (62.5%), 46.8 years of age, and smoked 16.3 cpd. No treatment group differences were found on the smoking or adherence outcome measures (p > .05). Collapsing across treatment, varenicline adherence was adequate (86.1%), yet despite a reduction of 12.2 (6.5) cpd from baseline to Month 3 (p < 0.001), only 23.6% were confirmed quit at Month 3. Participants who were quit at Month 3 had higher varenicline adherence rates (95.8%) than those who continued to smoke (80.8%, p ≤ .05). CONCLUSIONS: Studies are needed to examine the efficacy of varenicline among Black smokers. Interventions to facilitate adherence to pharmacotherapy warrant further attention as adherence is linked to improved tobacco abstinence.