FDA“治疗等效性评价供企业用指导原则”（草案）介绍

美国食品药品管理局（FDA）于2022年7月发布了"治疗等效性评价供企业用指导原则"（草案）。该指导原则阐明了FDA治疗等效性的标准以及治疗等效性编码系统，目的是准确评价仿制药与参比制剂的治疗等效性并通过治疗等效性代码，在"橙皮书"中迅速检索到治疗等效的仿制药。而中国目前尚无类似的指导原则，详细介绍FDA该指导原则主要内容，期望对中国加强仿制药的治疗等效性评价和加速完善和实施符合国情的治疗等效性编码系统有所帮助。     

Process evaluation of implementation strategies to reduce potentially inappropriate medication prescribing in older population: A scoping review

ObjectivesSeveral implementation strategies can reduce potentially inappropriate medication (PIM) prescribing. Although use of PIMs has declined in recent years, it remains prevalent. Various strategies exist to improve the appropriateness of medication use. However, little is known about the processes of these different implementation strategies. This scoping review aims to investigate how the process evaluation of implementation strategies for reducing PIM prescribing in the older population has been studied.MethodsWe searched for process evaluations of implementation strategies for reducing PIM prescribing in PUBMED, SCOPUS and Web of Science published between January 2000 and November 2019 in English. We applied the following inclusion criteria: patients aged ≥65 years, validated PIM criteria, and implementation process evaluated. The review focuses on decision support for health care professionals. We described the findings of the process evaluations, and compared the authors’ concepts of process evaluation of the included publications to those of Proctor et al.( 2010).ResultOf 9131 publications screened, 29 met our inclusion criteria. Different process evaluation conceptualizations were identified. Most process evaluations took place in the initial stages of the process (acceptability, adoption, appropriateness, and feasibility) and sustainability and implementation costs were seldom evaluated. None of the included publications evaluated fidelity.Multifaceted interventions were the most studied implementation strategies. Medication review was more common in acceptability evaluations, multidisciplinary interventions in adoption evaluations, and computerized systems and educational interventions in feasibility evaluations. Process evaluations were studied from the health care professionals’ viewpoint in most of the included publications, but the management viewpoint was missing.DiscussionThe conceptualization of process evaluation in the field of PIM prescribing is indeterminate. There is also a current gap in the knowledge of sustainability and implementation costs. Clarifying the conceptualization of implementation process evaluation is essential in order to effectively translate research knowledge into practice.     

Teach-Back健康教育模式对学龄期手足口病患儿家属疾病认知水平及防护行为的影响

目的:探讨Teach-Back健康教育模式对学龄期手足口病(HFMD)患儿家属疾病认知水平及防护行为的影响。方法:2018年7月—2020年11月选取我院学龄期113名HFMD患儿家属为研究对象,按照随机数字表法分为对照组56例与观察组57例,对照组给予常规健康教育干预,观察组给予Teach-Back健康教育模式干预,观察两组患儿家属疾病认知水平、行为干预遵从率、患儿症状改善状况。结果:干预后,观察组患儿家属发病原因、传播途径、隔离治疗、并发症预防认知评分高于对照组(P<0.05);观察组患儿家属消毒隔离措施、饭前便后洗手、勤晒衣被、居家开窗通风遵从率高于对照组(P<0.05);观察组患儿发热、口腔溃疡、皮疹、食欲减退改善时间短于对照组(P<0.05)。结论:对学龄期HFMD患儿家属开展Teach-Back健康教育模式,可明显提高家属对疾病认知水平,提高行为干预遵从率,促进患儿恢复。     

中医药预防结直肠癌术后复发转移的临床研究述评＊

对于结直肠癌患者，术后复发转移是导致其死亡的主要原因。大量研究显示中医药在结直肠癌复发转移的预防方面有着良好疗效。本文从临床研究入手，针对疾病不同分期，从结直肠癌术后辨证分型的临床研究及中医药预防结直肠癌复发转移的临床试验研究两方面展开论述，发现问题并给出未来临床研究方向的建议。本文旨在为结直肠癌术后复发转移中医药预防的临床研究提供思路和方法，把控好中医药在结直肠癌全过程防治中关键环节，更好地继承发扬中医药在“治未病”中的独特优势。     

MCI的情志病机及疏肝法干预的可行性探讨＊

轻度认知障碍（Mild cognition impairment， MCI）是尚未达到阿尔兹海默病（Alzheimer’s disease， AD）的诊断标准且可逆转为正常脑老化状态的最佳窗口期。情志异常、肝失疏泄（肝失疏泄日久致肝郁）已被证实为MCI的重要情志病机，且“长期负性情绪积累肝失疏泄致衰加速脑老化”的科学假说已在本课题组前期研究中得到初步证实，疏肝法干预肝郁型MCI患者疗效显著，但以上作用机制尚未得到完全阐述。因此本研究系统总结了中医学对MCI的认识，长期情绪不调肝失疏泄对MCI的影响及可能机制，疏肝解郁方药及其成分改善肝郁型MCI的可行性，并提出使用无束缚性设计的眼动技术以探索疏肝法改善肝郁型MCI的可行性，为MCI的中医药干预及其神经机制探讨提供新思路，为中医情志衰老学说增添新内涵。     

医院信息化平台住院陪护人员管理功能的开发与应用

目的 探讨医院信息系统中增加住院陪护管理功能的应用效果。方法 基于互联网医院、智慧医院等信息系统，开发信息化住院陪护管理功能，包括流行病学史调查、免费核酸申请、电子陪护证办理、体温监测登记及上报和统计查询。该功能与医院智慧护理链接后全院应用。比较功能应用前和应用后的遵医嘱一患一陪达标率、有效陪护证达标率、体温监测并登记日上报达标率和陪护证使用追溯率，评价护士和管理者疫情防控管理的人均耗时以及对该管理功能的满意度。结果 应用信息化陪护管理功能后，一患一陪达标率、有效陪护证达标率、体温监测并登记日上报达标率和陪护证使用追溯率显著高于应用前（均P＜0.05）；护士陪护管理人均耗时从（554.13±30.77）s降至（311.67±21.54）s（P＜0.05）；护士和管理者对该信息化陪护管理功能的满意度显著提高（均P＜0.05）。结论 信息化住院陪护管理功能的应用有效提升了疫情期间陪护的管理质量和管理效率，提高了一线护士和管理者的满意度。     

Policy Analysis for Prevention and Control of Influenza in Aged Care

ObjectiveThis study aimed to analyze national influenza infection control policy documents within aged care settings by identifying the consistencies, inconsistencies, and gaps with the current evidence and by evaluating methodological quality. Aged care providers can use these findings to identify their policy documents' strengths and weaknesses.DesignA quality and content analysis of national level policy documents.Setting and ParticipantsAged care settings rely on national agencies' policy recommendations to control and prevent outbreaks. There is limited research on the effectiveness of control measures to prevent and treat influenza within aged care settings. Because of the complexities around aged care governance, the primary responsibility in developing a comprehensive facility-level, infection-prevention policy, falls to the providers.MethodsThe analysis was conducted using the (1) International Appraisal of Guidelines, Research and Evaluation assessment tool, containing 23 items across 6 domains; and the (2) Influenza Related Control Measures in Aged Care settings checklist, developed by the authors, with 82 recommendations covering: medical interventions, nonmedical interventions, and physical layout.ResultsThere were 19 documents from 9 different high-income countries, with a moderately high methodological quality in general. The quality assessment's average score was 40.2% (95% CI 31.9%–44.7%). “Stakeholder involvement” ranked third, and “Editorial independence” and “Rigor of development” had the lowest average scores across all domains. The content analysis' average score was 37.2% (95% CI 10.5%–21.5%). The highest scoring document (59.1%) included term definitions, cited evidence for recommendations, and clear measurable instructions. “Physical Layout” had the least coverage and averaged 21.9% (95% CI 4.2%–37.5%), which shows a substantial gap in built environment recommendations.Conclusions and ImplicationsExisting policy documents vary in their comprehensiveness. The higher scoring documents provide an ideal model for providers. The checklist tools can be used to assess and enhance documents. Further research on document end-user evaluation would be useful, as there is room for improvement in methodological quality and coverage of recommendation coverage, especially related to physical layout.