开展医疗保障经办机构飞行检查的问题及其产生因素的质性研究

目的梳理总结我国开展医疗保障(以下简称“医保”)经办机构飞行检查的问题及其产生因素,为完善我国医保基金飞行检查机制,加强对医保经办机构的监管提供建议和参考。方法于2022年7—9月,采用典型抽样法,选取4个省份的医保专家进行半结构式访谈,样本量的确定以不再出现新的信息为标准,运用colaizzi七步分析法对获取的资料进行归纳分析。结果通过对11名专家访谈资料的分析,归纳提炼开展医保经办机构飞行检查的问题,包括力度不足、队伍构成不健全、缺乏具体内容及标准等,以及导致问题产生的因素,包括选择效应、缺乏标准化做法、区域差异等。结论医保经办机构的行为及工作效率影响着医保基金安全,对其进行监管十分必要,但开展医保经办机构飞行检查的过程中存在诸多问题。建议推进制度建设,加大飞行检查力度;丰富队伍构成,提升飞行检查质量;完善指标建立,规范飞行检查内容。

结核病患者手机应用程序督导服药的应用及其影响因素

目的分析上海市2021年新发非利福平耐药肺结核患者手机应用程序(application,APP)督导服药的应用情况及其影响因素,为进一步优化手机APP督导管理方式的应用策略提供依据。方法通过易督导患者管理系统(e-Patient Service System,e-PSS)平台收集患者管理数据,通过《中国疾病预防控制信息系统》结核病子系统收集患者性别、年龄组、职业、户籍、病原学结果等信息。对手机APP督导管理应用情况及相关影响因素进行统计分析。采用卡方检验和多因素非条件logistic回归分析结核病患者使用手机APP督导服药的影响因素。结果2021年上海市采用e-PSS平台管理患者2687例,其中使用手机APP督导服药的患者790例,占29.4%。使用手机APP督导服药的患者总体服药率为99.8%,总体规则服药率为99.5%,坚持打卡率为24.1%。多因素分析结果显示,病原学结果阳性(OR值为2.328,95%CI为1.474~3.825)及阴性(OR值为1.699,95%CI为1.067~2.809),年龄60岁及以下(≤20岁、>20~40岁、>40~60岁的OR值分别为11.017、16.864、9.002,95%CI分别为3.793~40.430、6.881~55.914、3.674~29.837),职业为农民(OR值为1.801,95%CI为1.289~2.519)的患者更倾向于使用手机APP进行服药管理。结论结核病患者日常服药管理应针对不同类型人群采用不同的督导管理方式,对于>20~40岁年龄组、病原学阳性、职业为农民、有合并症的结核病患者,社区医生可以优先推荐使用手机APP进行服药管理。

Could Labor Be Considered Outside of a Medical Environment in Africa? Case of the Maternity Hospital in Yopougon Attié/Abidjan/Ivory Coast/West Africa

Introduction: Developing countries are characterized by a high maternal mortality rate, particulary related to the management of childbirth. The author describes in this work 588 childbirth labors that took place without any medical supervision. Method: All patients who reached the hospital with a full cervix dilation were included in the study. The outcomes of those childbirth labors without medical supervision were evaluated at the maternal and neonatal level. Results and Discussion: The average age of the patients was 28.1 ± 13 years with 47% nulliparous and 30% pauciparous. These patients represented 14% of all births;59% of the patients had had three and five prenatal consultations. 71% of them came straight from home and had meconium-stained amniotic fluid. The APGAR score was greater than 6 in 94% of newborns, and 66.7 of them weighed between 2500 and 3500 g. Only 0.9% of patients coming from home needed a caesarean section. Conclusion: Home birth is not yet possible in Africa because it is not supervised by professionals who know the risks of childbirth, its complications and recognize the warning signs;however, the results of this preliminary study show that the issue of home childbirth in Côte d’Ivoire can be reconsidered subject to greater involvement of medical staffs.

Application of Real-World Evidence in Regulatory Decision-Making for Medical Devices

Objective To understand the real-world study(RWS)and its application in domestic and foreign pharmaceutical device regulatory decision-making,so as to promote its further application in the decision-making of medical devices supervision in China.Methods Literature analysis and comparative analysis were used to compare the real-world evidence(RWE)and randomized controlled trials to obtain the development status of medical devices in China and the United States.Results and Conclusion It is found that the application of RWS in the field of medical devices has many advantages,which can make up for the deficiencies of traditional clinical data.In addition,the RWE has a wide range of applications in the field of medical devices in China.In recent years,the RWE has received extensive attention in the medical field in the United States.The FDA has issued related guidelines,and its applications have gradually formed a complete system.Research on RWE will become the development trend of clinical evaluation of medical devices in the future.While attaching importance to the development of the RWE,China should learn from the specifications of relevant foreign organizations to improve its development in the field of health.