转基因作物的安全性评价策略、现状及发展

基因重组技术赋予农业生产以巨大的活力 ,但转基因作物的安全性问题却不容忽视。有关国际组织及政府已达成共识 :在“实质等同性”原则的基础上 ,应对转基因作物进行详尽周密的安全性评价工作。有关策略包括实质等同性分析、毒性实验、致敏性研究、营养学评价等 ,随着新技术的发展 ,基因组学、蛋白质组学、代谢组学等新技术也将用于对非目标效应的监测 ,欧盟已在酝酿上市后监测的一些措施。总之 ,转基因作物的安全性评价策略是十分严格的 ,且还在逐步完善。     

Building capacity for the continuous improvement of health-promoting schools

BACKGROUND: There has been much educational verbosity over the past decade related to building capacity for effective schools. However, there seems to be a scarcity of clarification about what is meant by school capacity building or how to accomplish and sustain this process. This article describes the preexisting conditions and ongoing processes in Pueblo, Colorado School District 60 (Pueblo 60) that built capacity for the development and continuous improvement of health-promoting schools. METHODS: Capacity building strategies and a program-planning model for continuous improvement for health-promoting schools were used that included: (a) visionary/effective leadership and management structures, (b) extensive internal and external supports, (c) development and allocation of adequate resources, (d) supportive policies and procedures, and (e) ongoing, embedded professional development. RESULTS: Pueblo 60 strategically developed an infrastructure through which they successfully delivered a wide array of health programs and services. CONCLUSIONS: Through building organizational capacity at the school district and school level, additional school health programming can be developed and sustained.     

Achieving early surgery for undescended testes: quality improvement through a multifaceted approach to guideline implementation

BACKGROUND: Surgery for undescended testes is recommended before the age of 2 years. However, boys are still undergoing surgery for undescended testes at a much later age than recommended. METHODS: An initial audit reviewed all orchidopexies performed at Northampton General Hospital between 1992 and 1994. This demonstrated that only 19% of boys had surgery by the age of 2 years, and the key reason for late surgery was late referral. Guidelines for referral of undescended testes were established in which referral to a surgeon was advised following the 8-month child health surveillance check if undescended testis was suspected. This would enable surgery before the age of 2 years. Audit results were disseminated and we implemented a package of measures based on evidence based change management techniques. These included written advice to general practitioners (GPs), a parent information leaflet and an amended personal child health record advising timing of referral. A reminder to the GP to refer following the 8-month check was generated using computer recall from the Child Health System records. Guideline implementation was monitored by annual audit and feedback. RESULTS: The baseline audit for the years 1992-94 found a median age at surgery of 4 years. Implementation of the new policies in 1998 resulted in a reduction in median age at surgery to 2.0 years in the 12 months ending September 2001. CONCLUSIONS: While concern about the age at orchidopexy has been highlighted in many previous studies, this is the first to show that improvement in the age at orchidopexy can be achieved. Implementing locally agreed guidelines with written information to GPs and parents combined with computerized recall from Child Health System records achieved the target within 3 years. Similar systems could be implemented nationally at minimal cost.     

北京地区3所大型综合医院住院患者体验和满意监测

目的了解北京3所大型综合医院的住院患者对医疗服务质量的看法和评价,为持续改进医疗服务质量提供科学依据。方法采用北京大学医学部住院患者体验和满意监测(PKU-VPSM)工具,对北京3所大型综合医院的住院患者进行信函问卷调查。结果3所医院的总体满意度平均得分为80.2分,医疗服务价值感知平均得分为74.4分,3所医院的总体服务质量指数平均得分为56.0分。结论3所医院为住院患者提供的服务和帮助总体上能够让广大住院患者满意和认可,反映出随着"医院管理年"和"创建人民满意医院"活动的持续开展,医院的服务水平和医患关系有了很大的进步和改善。虽然总体满意度得分接近或超过80分,但总体质量评价得分不到60分,说明医院服务质量仍然存在着较大的提升空间。     

基于多学科合作的早产儿随访门诊建立改进及其前后对照研究

目的 分析实施高危早产儿随访质量改进的效果, 为完善多学科合作的早产儿随访体系提供参考。方法 选取2017年7月1日-2018年7月31日, 从同济医院新生儿科出院的出生胎龄<32周和(或)出生体重<1 500 g的早产儿共268例, 纳入高危新生儿随访项目, 早期随访患儿为对照组(n=185), 给与常规出院指导与随访, 后期随访患儿为干预组(n=83), 实行随访质量改进措施, 比较两组高危早产儿在纠正月龄1个月、3个月及6个月的随访率以及6月龄Gesell 评分。结果 干预组和对照组患儿随访率在纠正月龄1个月时差异无统计学意义(P>0.05), 在3个月、6个月时干预组随访率均较对照组增高, 且差异有统计学意义(χ²＝5.307、7.965, P<0.05);纠正月龄6个月时干预组应物能和应人能得分高于对照组, 差异有统计学意义(t=2.719、3.661, P<0.05)。纠正月龄1个月、3个月及6个月均规律随访的早产儿, 其在大运动及应物能方面得分均高于未按规律随访的患儿(F＝8.486、7.056, P<0.05)。结论 高危早产儿随访质量改进可提高随访率, 间接促进早产儿的神经系统发育。     

The effects of quality improvement for depression in primary care at nine years: results from a randomized, controlled group-level trial

Objective

To examine 9-year outcomes of implementation of short-term quality improvement (QI) programs for depression in primary care.

Data Sources

Depressed primary care patients from six U.S. health care organizations.

Study Design

Group-level, randomized controlled trial.

Data Collection

Patients were randomly assigned to short-term QI programs supporting education and resources for medication management (QI-Meds) or access to evidence-based psychotherapy (QI-Therapy); and usual care (UC). Of 1,088 eligible patients, 805 (74 percent) completed 9-year follow-up; results were extrapolated to 1,269 initially enrolled and living. Outcomes were psychological well-being (Mental Health Inventory, five-item version [MHI5]), unmet need, services use, and intermediate outcomes.

Principal Findings

At 9 years, there were no overall intervention status effects on MHI5 or unmet need (largest F (2,41)=2.34, p=.11), but relative to UC, QI-Meds worsened MHI5, reduced effectiveness of coping and among whites lowered tangible social support (smallest t(42)=2.02, p=.05). The interventions reduced outpatient visits and increased perceived barriers to care among whites, but reduced attitudinal barriers due to racial discrimination and other factors among minorities (smallest F (2,41)=3.89, p=.03).

Conclusions

Main intervention effects were over but the results suggest some unintended negative consequences at 9 years particularly for the medication-resource intervention and shifts to greater perceived barriers among whites yet reduced attitudinal barriers among minorities.     

Rating the strength of scientific evidence: relevance for quality improvement programs.

OBJECTIVE: To summarize an extensive review of systems for grading the quality of research articles and rating the strength of bodies of evidence, and to highlight for health professionals and decision-makers concerned with quality measurement and improvement the available "best practices" tools by which these steps can be accomplished. DESIGN: Drawing on an extensive review of checklists, questionnaires, and other tools in the field of evidence-based practice, this paper discusses clinical, management, and policy rationales for rating strength of evidence in a quality improvement context, and documents best practices methods for these tasks. RESULTS: After review of 121 systems for grading the quality of articles, 19 systems, mostly STUDY DESIGN: specific, met a priori scientific standards for grading systematic reviews, randomized controlled trials, observational studies, and diagnostic tests; eight systems (of 40 reviewed) met similar standards for rating the overall strength of evidence. All can be used as is or adapted for particular types of evidence reports or systematic reviews. CONCLUSIONS: Formally grading study quality and rating overall strength of evidence, using sound instruments and procedures, can produce reasonable levels of confidence about the science base for parts of quality improvement programs. With such information, health care professionals and administrators concerned with quality improvement can understand better the level of science (versus only clinical consensus or opinion) that supports practice guidelines, review criteria, and assessments that feed into quality assurance and improvement programs. New systems are appearing and research is needed to confirm the conceptual and practical underpinnings of these grading and rating systems, but the need for those developing systematic reviews, practice guidelines, and quality or audit criteria to understand and undertake these steps is becoming increasingly clear.     

Planning and studying improvement in patient care: the use of theoretical perspectives

A consistent finding in articles on quality improvement in health care is that change is difficult to achieve. According to the research literature, the majority of interventions are targeted at health care professionals. But success in achieving change may be influenced by factors other than those relating to individual professionals, and theories may help explain whether change is possible. This article argues for a more systematic use of theories in planning and evaluating quality-improvement interventions in clinical practice. It demonstrates how different theories can be used to generate testable hypotheses regarding factors that influence the implementation of change, and it shows how different theoretical assumptions lead to different quality-improvement strategies.     

RNA interference against aldehyde dehydrogenase-2: development of tools for alcohol research

Liver alcohol dehydrogenase oxidizes ethanol to acetaldehyde, which is further oxidized to acetate by aldehyde dehydrogenase-2 (ALDH2*1). Individuals who carry a low-activity ALDH2 (ALDH2*2) display high blood acetaldehyde levels after ethanol consumption, which leads to dysphoric effects, such as facial flushing, nausea, dizziness, and headache (“Asian alcohol phenotype”), which result in an aversion to alcohol and protection against alcohol abuse and alcoholism. Mimicking this phenotype may reduce alcohol consumption in alcoholics. RNA interference (RNAi) is a cell process in which a short interfering RNA (siRNA) of 21-25 bp guides the degradation of a complementary target mRNA. Thus, siRNAs may be useful in mimicking the Asian phenotype by inhibiting ALDH2 gene expression. We determined the inhibitory effect of three chemically synthesized siRNAs targeted against rat ALDH2 mRNA in human embryonic kidney cells (HEK-293 cell lines) transfected with a plasmid carrying the rat ALDH2 cDNA. Two of the three siRNAs were active, yielding a 65-75% reduction of ALDH2 activity. Based on the most promising siRNA sequence, three short hairpin RNA (shRNA) genes driven by the human U6 RNA promoter were designed and cloned in a plasmid. After transfection of HEK-293 cells, one of the genes was shown to be active, yielding a 50% reduction of ALDH2 activity. This effect is consistent with a 50% reduction in ALDH2 mRNA, whereas neither β-actin mRNA nor the interferon-inducible transmembrane protein-1 mRNA levels were affected. This study describes chemically synthesized siRNAs and an endogenously synthesized shRNA, which reduce ALDH2 activity and constitute tools that should be of value for further alcohol research.     

Quality improvement for pressure ulcer care in the nursing home setting: the Northeast Pressure Ulcer Project

OBJECTIVES: The objectives of this study were to evaluate the impact of a collaborative model of quality improvement in nursing homes on processes of care for the prevention and treatment of pressure ulcers. STUDY DESIGN: The study design was experimental. SETTING: We studied 29 nursing homes in New Jersey, Pennsylvania, and Rhode Island. PARTICIPANTS: Participants consisted of pressure ulcer quality improvement teams in 29 nursing homes. INTERVENTION: Quality improvement teams attended a series of workshops to review clinical guidelines and quality improvement principles and to share best practices, and worked one-on-one with mentors to implement quality improvement techniques and to collect data independently. MEASUREMENTS: We calculated process measures based on the Agency for Healthcare Research and Quality (AHRQ) guidelines. Process measures addressed each facility's processes of care for the prevention and treatment of pressure ulcers at baseline and after 12 months of intervention. Prevention measures focused on recent admissions and high-risk residents; treatment measures focused on patients newly diagnosed with pressure ulcers and all patients with pressure ulcers. RESULTS: Overall, 6 of 8 prevention process measures improved significantly, with percent difference between baseline and follow up ranging from 11.6% to 24.5%. Three of 4 treatment process measures improved significantly, with 5.0%, 8.9%, and 25.9% difference between baseline and follow up. For each process measure, between 5 and 12 facilities demonstrated significant improvement between baseline and follow up, and only 2 or fewer declined for each process measure. CONCLUSION: Improvement in processes of care after the use of a structured collaborative quality improvement approach is possible in the nursing home setting.     

The influence of context on quality improvement success in health care: a systematic review of the literature

Context: The mixed results of success among QI initiatives may be due to differences in the context of these initiatives. Methods: The business and health care literature was systematically reviewed to identify contextual factors that might influence QI success; to categorize, summarize, and synthesize these factors; and to understand the current stage of development of this research field. Findings: Forty‐seven articles were included in the final review. Consistent with current theories of implementation and organization change, leadership from top management, organizational culture, data infrastructure and information systems, and years involved in QI were suggested as important to QI success. Other potentially important factors identified in this review included: physician involvement in QI, microsystem motivation to change, resources for QI, and QI team leadership. Key limitations in the existing literature were the lack of a practical conceptual model, the lack of clear definitions of contextual factors, and the lack of well‐specified measures. Conclusions: Several contextual factors were shown to be important to QI success, although the current body of literature lacks adequate definitions and is characterized by considerable variability in how contextual factors are measured across studies. Future research should focus on identifying and developing measures of context tied to a conceptual model that examines context across all levels of the health care system and explores the relationships among various aspects of context.     

Sourcing the crowd for health services improvement: The reflexive patient and "share-your-experience" websites

In countries where the notion of "reflexive patients" dominates the health policy landscape, patients are increasingly encouraged to publicize their personal experiences with health services provision by reviewing hospitals and professionals on the web. The number of websites where patients can review one or more aspects of their care (and read reviews posted by others) is growing. These sites are an example of the practice of crowdsourcing, where applications that facilitate user-generated content solicit feedback from a given public; site administrators then use this feedback for product development, quality improvement and policy change. The research presented here examines such developments in the context of ongoing discussions about reflexive consumerism and increased transparency in healthcare. It draws on data from a three-year study of share-your-experience sites in the U.S., U.K., and The Netherlands. Data is taken primarily from a discourse analysis of four of the six sites under study, including patient reviews of institutions and professionals (n=450). Supplementary data from interviews with stakeholders related to the Dutch sites (n=15) is also used. This is the first known study of multiple share-your-experience websites in different countries. It shows that monitoring as "reflexive" behavior is not automatic, but is encouraged by website creators who, hoping to use the posts for other purposes, act as mediators between patients and other healthcare stakeholders. It further argues that patients demonstrate more reflexivity than some stakeholders realize, although not necessarily in the way that Giddens proposed. It concludes with the argument that the focus on reflexivity in healthcare means that not only institutions must be more transparent about their performance; patients are expected to be more transparent about their choices, as well.     

Neither magic bullet nor a mere tool: negotiating multiple logics of the checklist in healthcare quality improvement

Over two decades, the checklist has risen to prominence in healthcare improvement. This paper contributes to the debate between its proponents and critics, making the case for an Science and Technology Studies‐informed understanding of the checklist that demonstrates the limitations of both the “checklist‐as‐panacea” and “checklist‐as‐socially‐determined” positions. Attending to the checklist as a socio‐material object endowed with affordances that call upon clinicians to act (Allen 2012, Hutchby 2001), the study revisits the efforts of a recent improvement initiative, the Enhanced Peri‐Operative Care for High‐risk patients trial. Rather than a singularised simple tool, this study discusses four different and relationally enacted logics of the checklist as a stop and check tool, a clinical prompt, an audit tool and a clinical record. Each logic is associated with specific temporality, beneficiaries, relationship with material forms, and interpellates (Law 2002) clinicians to initiate specific actions which can conflict. The paper seeks to make the case for intervention to improve such tools and consciously account for the consequences of their design and materiality and calls for supporting such settings and arrangements in which incoherences collected in tools can be locally negotiated.     

Explaining Michigan: developing an ex post theory of a quality improvement program

Context: Understanding how and why programs work—not simply whether they work—is crucial. Good theory is indispensable to advancing the science of improvement. We argue for the usefulness of ex post theorization of programs. Methods: We propose an approach, located within the broad family of theory‐oriented methods, for developing ex post theories of interventional programs. We use this approach to develop an ex post theory of the Michigan Intensive Care Unit (ICU) project, which attracted international attention by successfully reducing rates of central venous catheter bloodstream infections (CVC‐BSIs). The procedure used to develop the ex post theory was (1) identify program leaders’ initial theory of change and learning from running the program; (2) enhance this with new information in the form of theoretical contributions from social scientists; (3) synthesize prior and new information to produce an updated theory. Findings: The Michigan project achieved its effects by (1) generating isomorphic pressures for ICUs to join the program and conform to its requirements; (2) creating a densely networked community with strong horizontal links that exerted normative pressures on members; (3) reframing CVC‐BSIs as a social problem and addressing it through a professional movement combining “grassroots” features with a vertically integrating program structure; (4) using several interventions that functioned in different ways to shape a culture of commitment to doing better in practice; (5) harnessing data on infection rates as a disciplinary force; and (6) using “hard edges.” Conclusions: Updating program theory in the light of experience from program implementation is essential to improving programs’ generalizability and transferability, although it is not a substitute for concurrent evaluative fieldwork. Future iterations of programs based on the Michigan project, and improvement science more generally, may benefit from the updated theory present here.