中医药发展已上升到国家战略层面,在医药行业贯彻实施"中国制造2025"战略的新形势下,中药生产过程质量控制是中药工业需要加快突破的关键领域之一。对中药生产过程质量控制领域在工艺设计、分析检测、过程建模、制造装备等方面的关键共性问题进行解析,综述了中药生产过程质量控制体系中工艺过程理解、生产过程实时分析方法开发、过程控制策略建立3个方面的研究进展;并结合企业研究实践,介绍了质量源于设计(quality by design,Qb D)、过程分析技术(process analytical technology,PAT)、实验设计(design of experiment,DOE)、多变量统计分析等关键技术在上述3个研究方向中的应用进展,分析了实际工业应用的难点问题并对其应用前景进行展望,旨在为中药企业应用和提升生产过程质量控制技术提供参考。 相似文献
Background: There is a lack of occupation-focused instruments to assess Activities of Daily Living (ADL) that are intended for persons with mental disorders. The ADL Taxonomy is an instrument that is widely-used within clinical practice for persons with physical impairment. The aim of this study was to adapt the ADL Taxonomy for persons with mental disorders and evaluate its validity.
Methods: An expert group of Occupational Therapists (OTs) from psychiatric care adapted the ADL Taxonomy to fit the client group, including creating three new items. OTs in psychiatric care collected client data and evaluated the instrument for usability. Rasch analysis was used to evaluate the contruct validity of 16 activities separately.
Results: The OTs collected 123 assessments from clients with various mental disorders. Ten activities had excellent, and four had acceptable, psychometric properties with regard to item and person fit and unidimensionality. The activity managing the day/time gave complex results and would benefit from further development. The OTs found the test version intelligible, relevant and easy to use.
Conclusions: The ADL Taxonomy for persons with mental disorders has 16 activities with three to six actions each, and is now ready for clinical use. 相似文献
Bronchoscopy is the safest procedure for lung cancer diagnosis when an invasive evaluation is required after imaging procedures. However, its sensitivity is relatively low, especially for small and peripheral lesions. We assessed benefits and costs of introducing a bronchial gene-expression classifier (BGC) to improve the performance of bronchoscopy and the overall diagnostic process for early detection of lung cancer. We used discrete-event simulation to compare clinical and economic outcomes of two different strategies with the standard practice in former and current smokers with indeterminate nodules: (i) location-based strategy—integrated the BGC to the bronchoscopy indication; (ii) simplified strategy—extended use of bronchoscopy plus BGC also on small and peripheral lesions. Outcomes modeled were rate of invasive procedures, quality-adjusted-life-years (QALYs), costs and incremental cost-effectiveness ratios. Compared to the standard practice, the location-based strategy (i) reduced absolute rate of invasive procedures by 3.3% without increasing costs at the current BGC market price. It resulted in savings when the BGC price was less than $3,000. The simplified strategy (ii) reduced absolute rate of invasive procedures by 10% and improved quality-adjusted life expectancy, producing an incremental cost-effectiveness ratio of $10,109 per QALY. In patients with indeterminate nodules, both BGC strategies reduced unnecessary invasive procedures at high risk of adverse events. Moreover, compared to the standard practice, the simplified use of BGC for central and peripheral lesions resulted in larger QALYs gains at acceptable cost. The location-based is cost-saving if the price of classifier declines. 相似文献
It is useful for reviewers of economic evaluations to assess quality in a manner that is consistent and comprehensive. Checklists can allow this, but there are concerns about their reliability and how they are used in practice. We aimed to describe how checklists have been used in systematic reviews of health economic evaluations.
Methods
Meta-review with snowball sampling. We compiled a list of checklists for health economic evaluations and searched for the checklists’ use in systematic reviews from January 2010 to February 2018. We extracted data regarding checklists used, stated checklist function, subject area, number of reviewers, and issues expressed about checklists.
Results
We found 346 systematic reviews since 2010 that used checklists to assess economic evaluations. The most common checklist in use was developed in 1996 by Drummond and Jefferson, and the most common stated use of a checklist was quality assessment. Checklists and their use varied within subject areas; 223 reviews had more than one reviewer who used the checklist.
Conclusions
Use of checklists is inconsistent. Eighteen individual checklists have been used since 2010, many of which have been used in ways different from those originally intended, often without justification. Different systematic reviews in the same subject areas would benefit from using one checklist exclusively, using checklists as intended, and having 2 reviewers complete the checklist. This would increase the likelihood that results are transparent and comparable over time. 相似文献