Estimating live birth rates after ovulation induction in polycystic ovary syndrome: sample size calculations for the pregnancy in polycystic ovary syndrome trial

Polycystic ovary syndrome (PCOS) affects approximately 5% of the female population, and is a leading cause of infertility, primarily secondary to anovulation. Clomiphene citrate has been standard therapy for ovulation induction in patients seeking pregnancy, but recent evidence suggests that insulin sensitizing agents such as metformin may also be effective. The National Institute of Child Health and Human Development's Reproductive Medicine Network has begun a randomized, double-blind trial of clomiphene vs. metformin vs. clomiphene plus metformin for the induction of ovulation in patients with PCOS seeking pregnancy, with live birth rate as the primary outcome. Because the available literature was largely limited to surrogate outcomes such as ovulation and pregnancy rates, we created a Markov model to derive estimates of likely live birth rates in each arm. Using these estimates, we then constructed an algorithm that allowed only two formal comparisons between the three arms. First, we assumed that combination therapy would have to be superior to the next best single-agent therapy in order to be preferred, because of complexity, costs, increased side effects, etc. If combination therapy is not superior to the next best single agent, then the only other comparison of interest is between the two single agent therapies. Because the third possible comparison, between the best and worst of the three therapies, is not clinically relevant, it can be eliminated from formal statistical consideration, with subsequent reduction in sample size. Based on the opinion of the Network Steering Committee that a 15% absolute difference in live birth rates would be clinically relevant, our methodology resulted in a sample size of 226 per arm, or a total of 678 subjects. The PPCOS trial should definitively answer the question of the relative efficacy of metformin, clomiphene, and combination therapy in the treatment of infertile women with PCOS.     

依法加强对医疗废物的管理

论述了制定《医疗废物管理条例》的必要性和《医疗废物管理条例》的基本原则、思路,介绍了国际上医疗废物管理的状况和国务院颁发的《医疗废物管理条例》的主要内容。     

A systematic review of outcome and outcome-measure reporting in randomised trials evaluating surgical interventions for anterior-compartment vaginal prolapse: a call to action to develop a core outcome set

Introduction

We assessed outcome and outcome-measure reporting in randomised controlled trials evaluating surgical interventions for anterior-compartment vaginal prolapse and explored the relationships between outcome reporting quality with journal impact factor, year of publication, and methodological quality.

Methods

We searched the bibliographical databases from inception to October 2017. Two researchers independently selected studies and assessed study characteristics, methodological quality (Jadad criteria; range 1–5), and outcome reporting quality Management of Otitis Media with Effusion in Cleft Palate (MOMENT) criteria; range 1–6], and extracted relevant data. We used a multivariate linear regression to assess associations between outcome reporting quality and other variables.

Results

Eighty publications reporting data from 10,924 participants were included. Seventeen different surgical interventions were evaluated. One hundred different outcomes and 112 outcome measures were reported. Outcomes were inconsistently reported across trials; for example, 43 trials reported anatomical treatment success rates (12 outcome measures), 25 trials reported quality of life (15 outcome measures) and eight trials reported postoperative pain (seven outcome measures). Multivariate linear regression demonstrated a relationship between outcome reporting quality with methodological quality (β?=?0.412; P?=?0.018). No relationship was demonstrated between outcome reporting quality with impact factor (β?=?0.078; P?=?0.306), year of publication (β?=?0.149; P?=?0.295), study size (β?=?0.008; P?=?0.961) and commercial funding (β?=??0.013; P?=?0.918).

Conclusions

Anterior-compartment vaginal prolapse trials report many different outcomes and outcome measures and often neglect to report important safety outcomes. Developing, disseminating and implementing a core outcome set will help address these issues.

     

步行锻炼对慢性乙型肝炎患者肝功能和生活质量的影响

目的为验证运动疗法促进肝功能恢复的假设,探讨步行锻炼对慢性乙型肝炎患者肝功能和生活质量的影响。方法73例慢性乙型肝炎患者每天进行30min以上的匀速步行锻炼,持续2个月,同时给予药物治疗。68例对照组仅进行药物治疗。于开始步行锻炼和药物治疗前以及治疗结束后1周内,分别检测HBVM(HbsAg、抗-HBs、HbcAg、抗-Hbe及抗-HBc)、HBVDNA、肝、肾功能、血糖和血脂、血常规。采用健康调查简易量表(medicaloutcomesstudy,SF-36)评定生活质量指数(QLI)。结果两组患者的多数肝功能指标均较治疗前有显著改善(χ2=2.784,P<0.05),但组间差异不明显(χ2=1.956～2.312,P>0.05)。治疗后步行锻炼组的SF-36生活质量问卷得分不仅明显高于治疗前(t=2.1～2.8,P<0.01～0.05),同时也优于对照组(t=2.1～2.4,P<0.05)。两组的完全反应、部分反应和无反应例数分布接近,无明显差异(χ2=2.784,P>0.05)。结论短期步行锻炼能显著改善慢性乙型肝炎患者的生活质量,但对肝功能指标影响不大。     

头孢吡肟等抗生素对革兰阴性杆菌体外敏感性连续四年耐药性监测分析

目的监测和了解头孢吡肟对临床常见革兰阴性菌体外抗菌活性。方法从1999～2002年收集的临床常见革兰阴性杆菌50528株(主要为尿液、痰、伤口及其分泌物标本)，连续监测4年。药物敏感性试验采用纸片扩散法，WHONET5软件进行结果分析。结果1999～2002年头孢吡肟对肠杆菌科细菌的敏感性为70．0％-95．2％；对铜绿假单胞菌敏感性为73．9％-77．5％。1999-2002年肠杆菌科细菌临床分离株对头孢噻肟、头孢他啶和头孢吡肟耐药性变迁的比较表明，头孢吡肟耐药率增加幅度低于头孢噻肟、头孢他啶；铜绿假单胞菌对头孢吡肟耐药率增加幅度明显低于哌拉西林、阿米卡星和头孢他啶。结论头孢吡肟对大肠埃希菌、肺炎克雷伯菌、弗劳地枸橼酸杆菌、产气肠杆菌、阴沟肠杆菌、奇异变形杆菌、铜绿假单胞菌和鲍曼不动杆菌有较好的体外抗菌活性。     

不良道德因素对临床思维的影响

临床思维是影响临床诊断的一个重要主观因素。临床思维的正确与否，虽然受各种主客观条件的制约，但道德因素对临床思难的影响是不可忽视的。不良道德因素可导致临床思维的表浅化、狭窄化及惰性化三方面的错误与偏差。因此，在加强临床思维方法训练的同时，更应注重自身道德素质的培养。     

Characteristics associated with participation in DNA banking: The National Registry of Veterans with ALS

OBJECTIVE: Characteristics that may influence participation in DNA banks are not well defined. The purpose of this study was to examine characteristics associated with participation in a DNA bank among veterans diagnosed with Amyotrophic Lateral Sclerosis (ALS). METHODS: Veterans who screened eligible for the National Registry of Veterans with ALS were initially contacted about the DNA Bank via telephone and then mailed a consent form. Registry participants were then categorized as consented for the DNA bank, actively refused, or passively refused (consent form not returned after >3 months and multiple reminders). The associations of consent status with age, gender, race, military branch, years of military service, VA health system use, and ALS Functional Rating Scale (ALSFRS) scores were examined. RESULTS: Registry participants (N=1020) were 98% male, 9.5% non-white, and the mean age was 64.1 years. 61.1% of participants were current VA health system users, and the branches of service were: Army (46.1%), Navy (22.1%), Air Force (23.2%), and Marines (8.3%). A total of 14.7% of Registry participants refused DNA banking (9.4% active refusal, 5.3% passive refusal). Results from multivariable models indicated participants who were non-White, VA users, or had lower ALSFRS scores (reflecting poorer function) had higher odds of refusal. Race and VA use were associated with active refusal, while age and ALSFRS score were associated with passive refusal. CONCLUSION: Although the overall refusal rate for DNA banking was relatively low, we still found important differences in consent by race, VA use, and functional status in this cohort of veterans with ALS. Because differential participation in DNA banking may influence generalizability, further efforts are needed to understand and intervene to reduce these differences.