基于理论域框架的ICU护士执行身体约束缩减行动障碍因素的质性研究

目的：探讨ICU护士执行身体约束缩减行动的障碍因素，为制定身体约束标准化管理方案提供依据。方法：基于理论域框架（TDF）制定访谈提纲，采用目的抽样法对天津市某三级甲等医院的12名ICU护士进行半结构式访谈，按照TDF的相关领域对转录后的资料进行归类，用内容分析法对访谈资料进行分析。结果：ICU护士对身体约束缩减行动理解存在偏差、对约束替代措施内容的不熟悉是其执行身体约束缩减行动的障碍因素之一；身体约束缩减方案评估工具、决策流程的不规范对缩减约束行动的开展造成了一定阻碍；环境因素的限制及对缩减约束结果的担忧，使ICU护士没有足够的信心去执行；科室缺乏支持缩减约束的组织氛围，难以引起护士对执行约束缩减行动的重视，进而削减执行的动力。结合理论域框架将上述因素分别归属为知识、自我效能、环境背景和资源、社会影响、行为规范5个领域。结论：知识、自我效能、环境背景和资源、社会影响及行为规范为ICU护士执行身体约束缩减行动的障碍因素。科室要在明确障碍因素的基础上，加强领导层对执行缩减约束的重视和支持。制定缩减约束评估决策规范化流程以及培训方案，倡导团队协作，创造支持身体约束缩减行动的组织氛围，坚定ICU护士执行缩减约束的信心，促进身体约束缩减行动的持续实施。     

基于HPLC指纹图谱、多指标成分含量测定结合化学计量学的怀牛膝质量评价＊

目的 本实验采用HPLC方法建立来自3个产地15批怀牛膝药材的指纹图谱，并对β-蜕皮甾酮，25R-牛膝甾酮，25S-牛膝甾酮进行含量测定，同时通过化学计量学的方法对15批怀牛膝进行质量评价。方法 选用Waters SunFire C₁₈（150 mm×4.6 mm，5 μm）色谱柱，检测波长280 nm，以乙腈-0.1%甲酸水梯度洗脱，流速为1.0 mL·min^-1，柱温25℃，进样量10 μL。以β-蜕皮甾酮峰为参照峰，运用软件《中药色谱指纹图谱相似度评价系统（2012版）》对15批怀牛膝药材进行相似度分析，使用Metabo Analyst 5.0网站进行聚类热图分析，使用SIMCA 14.1软件进行PCA和PLS-DA分析。结果 标定了31个共有指纹峰，指认了3个已知成分，并对其进行含量测定，化学计量学分析结果将15批怀牛膝药材样品分为3类，并且筛选了不同产地间潜在的差异性成分。结论 该方法具有良好的精密度、重复性以及稳定性，可为怀牛膝的质量评价与控制提供科学依据及参考。     

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.     

NEMA NU 2-2018标准在PET/CT系统性能测试中的作用评价

目的 评价美国国家电器制造协会(National Electrical Manufactures Association, NEMA)最新标准(NU 2-2018)在正电子发射型计算机断层显像/电子计算机断层显像(positron emission tomography/computed tomography, PET/CT)设备性能检测中的作用。 方法 依据最新的NEMA NU 2-2018标准,检测西门子Biograph Vision PET/CT的空间分辨率、灵敏度、散射分数、计数丢失、随机符合、飞行时间分辨率、计数丢失率和随机符合校正精度、图像质量、衰减和散射校正精度及PET与CT配准精度指标。 结果 距视野中心1 cm处横向和轴向空间分辨率分别为3.75 mm和3.76 mm;在视野中心和轴向10 cm处的灵敏度分别为16.83 kcps/MBq和16.67 kcps/MBq;放射性浓度为27.37 kBq/mL时,最大等效噪声计数率为258.26 kcps,散射分数为38.58%;系统时间分辨率为209.82 ps;图像质量模型的对比度恢复系数范围为88.9%~96.2%,背景变异系数范围为2.05%~6.80%,平均肺插件残余误差为2.43%;计数丢失和随机符合校正最大误差为3.9%;距离床板末端 5 cm 和 100 cm处,在距视野中心Y轴1 cm处,PET和CT的配准精度分别为0.46 mm和1.07 mm,在距视野中心X轴20 cm处,PET和CT的配准精度分别为1.06 mm和1.45 mm,在距视野中心Y轴20 cm处PET和CT的配准精度分别为0.85 mm和1.15 mm。 结论 NEMA NU 2-2018标准检测条件更加接近临床,能更好地反映PET/CT设备的系统性能。     

Estimating Cost-Effectiveness Using Alternative Preference-Based Scores and Within-Trial Methods: Exploring the Dynamics of the Quality-Adjusted Life-Year Using the EQ-5D 5-Level Version and Recovering Quality of Life Utility Index

ObjectivesThis study aimed to explore quality-adjusted life-year (QALY) and subsequent cost-effectiveness estimates based on the more physical health–focused EQ-5D 5-level version (EQ-5D-5L) value set for England or cross-walked EQ-5D 3-level version UK value set scores or more mental health recovery-focused Recovering Quality of Life Utility Index (ReQoL-UI), when using alternative within-trial statistical methods. We describe possible reasons for the different QALY estimates based on the interaction between item scores, health state profiles, preference-based scores, and mathematical and statistical methods chosen.MethodsQALYs are calculated over 8 weeks from a case study 2:1 (intervention:control) randomized controlled trial in patients with anxiety or depression. Complete case and with missing cases imputed using multiple-imputation analyses are conducted, using unadjusted and regression baseline-adjusted QALYs. Cost-effectiveness is judged using incremental cost-effectiveness ratios and acceptability curves. We use previously established psychometric results to reflect on estimated QALYs.ResultsA total of 361 people (241:120) were randomized. EQ-5D-5L crosswalk produced higher incremental QALYs than the value set for England or ReQoL-UI, which produced similar unadjusted QALYs, but contrasting baseline-adjusted QALYs. Probability of cost-effectiveness <£30 000 per QALY ranged from 6% (complete case ReQoL-UI baseline-adjusted QALYs) to 64.3% (multiple-imputation EQ-5D-5L crosswalk unadjusted QALYs). The control arm improved more on average than the intervention arm on the ReQoL-UI, a result not mirrored on the EQ-5D-5L nor condition-specific (Patient-Health Questionnaire-9, depression; Generalized Anxiety Disorder-7, anxiety) measures.ConclusionsReQoL-UI produced contradictory cost-effectiveness results relative to the EQ-5D-5L. The EQ-5D-5L’s better responsiveness and “anxiety/depression” and “usual activities” items drove the incremental QALY results. The ReQoL-UI’s single physical health item and “personal recovery” construct may have influenced its lower 8-week incremental QALY estimates in this patient sample.     

Adopting global tools for the advancement of pharmacy practice and workforce in Saudi Arabia

BackgroundThe continuing expansion of the pharmacist’s role necessitates continuous evaluation of current practice to identify strategies for improvements. The International Pharmaceutical Federation (FIP) has developed tools to support stakeholders in identifying development needs and planning advancement strategies. The aim of this research was to utilise the FIP Global Competency Framework, version 2 (GbCF v2), and FIP Development Goals (DGs) to evaluate competencies related to pharmacy practice in Saudi Arabia, and to understand the strategies needed to develop and improve the current practice.MethodsThe study involved four phases. Phase 1 involved translation of the FIP GbCF v2 into the Arabic language. Phase 2 was a consensus panel validation to establish the initial relevance of the competencies to current practice. Phase 3 included a national survey distributed to all registered pharmacists in Saudi Arabia. The final phase was conducted through mapping ‘not relevant’ competencies to FIP DGs to identify priorities.ResultsThe translation phase yielded a bilingual framework that could be utilized by pharmacists in Saudi Arabia. The initial validation phase identified 61 behavioral statements (from 124 in the GbCF v2) as ‘highly relevant’ or ‘relevant’ to pharmacy practice. Findings from the national survey identified a list of ‘not relevant’ competencies that could highlight gaps in current practice. The final mapping phase generated a list of three FIP DG priorities: DG5 (competency development), DG8 (working with others) and DG11 (impact and outcomes).ConclusionThe study indicated that competencies in the GbCF v2 were relevant to pharmacists practicing in the country. However, some competencies were perceived as ‘not relevant’ to current practice and these highlighted gaps in the current practice that need attention. Mapping ‘not relevant’ competencies to FIP DGs should be used as a starting point towards developing strategies, systems, and protocols to advance pharmacy practice in Saudi Arabia.     

Orphan drug development: The impact of regulatory and reimbursement frameworks

The enactment of orphan drug-specific legislation pioneered by the USA was subsequently followed by many regions, including the European Union (EU), Australia, Japan, and Taiwan. Here, we discuss the associated regulations established and their impacts in the aforementioned regions, which are among the first with frameworks specific for orphan drugs. Varied scopes of rare diseases or orphan drugs, diverse incentives, and heterogeneous types of reimbursement systems imply the prioritization of the agencies concerned. The numbers of designated and approved drugs reflect the impact of the regulatory and reimbursement frameworks. A comparison of the frameworks and their impact in the respective regions could provide valuable information for developing and improving related frameworks for countries worldwide.