医疗器械结果研究设计及模型的构建

目的:探讨结果研究在医疗器械中的应用及其研究设计方案,为科学设计医疗器械结果研究提供指导,并构建适用于医疗器械不同发展阶段的结果研究模型。方法:全面分析医疗器械结果研究设计流程、研究设计类型选择及在结果测量指标设定等方面的关键考虑点,发现不同研究设计类型在医疗器械发展进程中的适用范围,并结合案例进行具体分析。结果:提出了指导医疗器械不同发展阶段的结果研究设计方法,即多阶段结果研究模型。结论:医疗器械结果研究设计非常复杂,应根据不同情况选择不同的研究方案设计。将医疗器械结果研究纳入医疗器械上市前后的不同阶段,对于提高医疗器械的安全性、有效性、经济性及医疗器械资源的合理配置可能具有重要意义,其量化结果有待进一步研究。     

风情奇特的马赛人

居住于非洲东部高原上的马赛族人，更是以其不同的人种特征，剽悍的种族个性，鲜艳多彩的装束和别具一格的风土人情而声名远扬。     

植入性医疗器械追溯管理系统的设计

目的：设计一种植入性医疗器械追溯管理系统,对植入性医疗器械进行信息化管理。方法：采用条形码技术录入植入性医疗器械产品数据,建立数据库,实现数据管理和信息监管。结果：系统以其产品编码化、数据标准化、管理信息化、监管全程化和信息透明化的特点,建立了可追溯的长效监管机制。结论：该系统的应用确保了植入性医疗器械使用的安全性和可溯性,不仅提高了医院管理水平,而且为患者提供了更佳的服务保障。     

国际医疗器械安全性信息适时监测和分析研究

本课题是上海市食品药品安全研究中心、上海市药品不良反应监测中心接受国家药品不良反应监测中心、国家食品药品监督管理局药品评价中心委托开展的“全球医疗器械安全性信息适时监测和分析”研究。旨在通过研究国外,特别是欧美发达国家医疗器械监管部门发布的医疗器械召回、医疗器械警戒等信息,借鉴这些发达国家在医疗器械安全性信息监测方面的经验,为我国医疗器械的安全性监测、安全评价、医疗器械警戒以及风险管理等提供相关的参考数据,推动我国上市后医疗器械监管水平的提高。     

医疗器械的用户定义和用户需求确定

定义用户和确定用户的需求是医疗器械设计开发中最基本的要求,是医疗器械设计开发必需的,因为设计开发过程中纳入用户需求可以带来很多价值.医疗器械的用户也并非通常认为的医生,而是复杂很多.情景调查法是最常用的确定医疗器械用户需求的方法,在纳入真实用户困难的时候可以适当地选择用户代理人,在时间和金钱有限情况下应该平衡运用各种方法确定用户需求.     

人机工程在医疗器械设计中的应用

目前医疗器械产品的科技含量在不断提高,但在人机工程设计这一方面的重视程度依然不够.本文主要讲述了医疗器械人机工程学的概念、设计原则和内容.分析了医疗器械产品中人的因素特点、设备的安全性、医疗器械的使用环境等特点,提出了医疗器械产品设计应"以人为中心"的设计过程的理念.从医疗器械的人机界面方面进行了分析研究,提出了医疗器械具有双重人机界面的观点并对人机界面进行了分析研究.通过对对医疗器械的造型设计、色彩设计、触角设计、作业空间设计以及材质选择进行分析,阐述了医疗器械设计的选用原则,最后对医疗器械的人机工程发展趋势进行分析.人机工程在医疗器械设计中起着越来越重要的地位,对医疗器械产品设计的发展方向具有重要的指导意义.     

医疗器械验证中的临床方法分析

医疗器械通常经过直接或间接的物理途径,达到对疾病有效诊断及治疗的目的。而由于医疗器械诊疗方式的多样化,故存在应用风险,因此世界各国均采取了多种监管手段,以控制其应用的风险程度。医疗仪器的临床验证方式分为间接临床验证和直接临床验证。但目前仍有大量的生命信息监测技术尚无统一的参考标准,在实际的实施中只能以上述方式为参考。而模块化设计作为当今医疗器械产品开发的趋势,能够通过开发和使用统一的模块,并对模块的安全性和有效性加以验证,从而控制医疗器械开发成本。     

美国FDA医疗器械开发工具项目的分析与思考

2017年，美国FDA启动了医疗器械开发工具项目。医疗器械开发工具项目是美国FDA对医疗器械开发过程中使用的方法、材料和测量手段进行的资质认证。经认证的工具能够填补指南、标准的空白，使医疗器械厂商节省在测试环节的时间和精力，将更多的资源集中到新产品的性能上，加快上市速度。文章对美国FDA发布的医疗器械开发工具项目的成立背景、认证过程以及至今批准的项目进行了全面介绍与分析。医疗器械开发工具能够有效评估医疗器械的安全性、有效性和性能，大大简化了医疗器械开发和审查过程。FDA的医疗器械开发工具体现了最小负担原则的监管思路，为我国的医疗器械监管，尤其是创新医疗器械监管思路提供了有益参考。     

有源植入式医疗器械的电池技术发展

有源植入式医疗器械近年来成为医疗器械的热点,电池是这类装置最关键的部件,多种电池被开发出来满足了不同的植入应用,这些电池有着相同的需求,包括高安全性、高可靠性、高能量密度、长寿命、良好的寿命指示等,该文介绍了有源植入装置电池的应用历史、现状和展望.     

医疗器械软件的要求和评价

论述了医疗器械软件的安全性和有效性要求．并从软件开发设计过程和软件产品两方面论述如何对医疗器械软件进行评价。     

Patient-physician racial and ethnic concordance and perceived medical errors

In this paper, I use nationally representative survey data to examine the relationship between patient-physician racial/ethnic concordance and perceived medical errors in the USA. After adjusting for potential confounding factors, we find that White patients treated by White physicians have 33% lower odds of reporting medical errors than White patients treated by non-White physicians. In contrast, patient-physician racial/ethnic concordance has no effect on perceived medical errors among non-White patients. The results suggest that the role of racial/ethnic concordance in perceptions of health care safety varies by patients' racial/ethnic background.     

Family,neighbourhood, and children’s health: Trends and racial/ethnic disparities between 2003 and 2007 in the U.S.

The present study examined the race/ethnicity-specific trend of parent-reported health among children aged 17 years and under in the U.S. between 2003 and 2007, and its relationship with family background, neighbourhood support and neighbourhood safety. Data from the 2003 and 2007 National Survey of Children’s Health (NSCH) were merged and analysed after taking into account the weighting and the complex sampling design of the data. Trends in children’s health and racial/ethnic disparities were identified for this time period. Multivariate models were analysed to examine the association between children’s health and their family background variables, neighbourhood support and safety, and other socio-demographic variables. Race/ethnicity-specific stratified models were also performed. Our findings indicated an adverse trend in the parent-reported health among children in the U.S. from 2003 to 2007, and little progress has been made towards reducing the health disparities by race/ethnicity. Racial/ethnic disparities also existed in children’s family background and neighbourhood support and safety. Further, the health effects of family background and neighbourhood characteristics differed in magnitudes and directions by race/ethnicity. These findings suggest that different intervention/prevention strategies should be employed in improving childhood health for different racial/ethnic groups.     

Institutional variation in the promotion of racial/ethnic minority faculty at US medical schools

Objectives. We compared faculty promotion rates by race/ethnicity across US academic medical centers.Methods. We used the Association of American Medical College''s 1983 through 2000 faculty roster data to estimate median institution-specific promotion rates for assistant professor to associate professor and for associate professor to full professor. In unadjusted analyses, we compared medians for Hispanic and Black with White faculty using the Wilcoxon rank sum test. We compared institution-specific promotion rates between racial/ethnic groups with data stratified by institutional characteristic (institution size, proportion racial/ethnic minority faculty, and proportion women faculty) using the χ² test. Our sample included 128 academic medical centers and 88 432 unique faculty.Results. The median institution-specific promotion rates for White, Hispanic, and Black faculty, respectively, were 30.2%, 23.5%, and 18.8% (P < .01) from assistant to associate professor and 31.5%, 25.0%, and 16.7% (P < .01) from associate to full professor.Conclusions. At most academic medical centers, promotion rates for Hispanic and Black were lower than those for White faculty. Equitable faculty promotion rates may reflect institutional climates that support the successful development of racial/ethnic minority trainees, ultimately improving healthcare access and quality for all patients.The racial/ethnic composition of the healthcare workforce does not reflect the diversity in the US general population. Although combined Blacks and Hispanics represent 28.7% of the total US population,1 only 8.4% of all practicing US physicians are Black or Hispanic.2,3 These disparities extend to academic medical center faculty. Historically underrepresented racial/ethnic minorities constitute 7% of all current academic medical center faculty and fewer than 5% of all new academic medical center faculty.2,4The rationale for supporting racial/ethnic diversity across the academic medical center faculty workforce is multifold. Faculty diversity increases the quality of training for all students, and racial/ethnic minority faculty often serve as important professional resources for racial/ethnic minority trainees.5,6 This is a critical role within the social mission of academic medical centers to develop a diverse practicing physician workforce, which is necessary to reduce healthcare discrimination and increase healthcare access and quality.7–9 Racial/ethnic minority faculty also often provide leadership in medical education, health policy, and research scholarship related to racial/ethnic health inequities. Despite these benefits, academic medical centers struggle to retain racial/ethnic diversity across faculty ranks.Institutional discrimination in the promotion process has been suggested as a potential explanation for the persistent lack of diversity at the senior faculty level associate professor and full professor ranks.10 The majority of Black and Hispanic academic medical center faculty are concentrated at the assistant professor level; among all racial/ethnic groups, men are more likely than are women to hold full professor rank.4 Aggregated national data have described lower career satisfaction among racial/ethnic minority academic medical center faculty, lower promotion rates compared with White peers despite adjustment for established measures of productivity, and decreased likelihood of being awarded research grants from the National Institutes of Health after controlling for several key factors.10–14 Other research has concluded that many physician academic medical center faculty, particularly racial/ethnic minorities, experience a poor institutional diversity climate or discrimination at work.15–18 Although recent data demonstrate increases in the overall numbers of first time racial/ethnic minority assistant professors and medical students,10,19 national averages that reveal lower and slower promotion rates for racial/ethnic minority faculty raise concerns about the success of organizational efforts to successfully diversify the academic medical center faculty workforce.10,13Despite consistent national data on differential career trajectories for racial/ethnic minority academic medical center faculty, it is unknown whether all academic medical centers face similar challenges in the promotion process. The Association of American Medical College''s Faculty Roster database provided us a unique opportunity to examine in detail the promotion disparities between racial/ethnic faculty at individual academic medical centers in the United States. We hypothesized that Black and Hispanic faculty would have lower rates of promotion to associate professor and full professor than would White faculty at most academic medical centers. We also sought to explore whether larger academic medical centers and academic medical centers with higher proportions of Black, Hispanic, or women faculty would approach promotion rate equity across faculty race/ethnicity.We estimated the median institution-specific faculty promotion rates by race/ethnicity across academic medical centers and described the proportion of academic medical centers with faculty promotion rate gaps by race/ethnicity. We also investigated whether selected institutional characteristics were associated with promotion rates for academic medical center faculty by race/ethnicity.     

Spatial association of racial/ethnic disparities between late-stage diagnosis and mortality for female breast cancer: where to intervene?

Background  

Over the past twenty years, racial/ethnic disparities between late-stage diagnoses and mortality outcomes have widened due to disproportionate medical benefits that different racial/ethnic groups have received. Few studies to date have examined the spatial relationships of racial/ethnic disparities between breast cancer late-stage diagnosis and mortality as well as the impact of socioeconomic status (SES) on these two disparities at finer geographic scales.     

Commentary: considerations for use of racial/ethnic classification in etiologic research

Numerous authors have critiqued the use of race as an etiologic quantity in medical research. Despite this criticism, the use of variables encoding racial/ethnic categorization has increased in epidemiology, and most researchers agree that important variation in disease risk is captured by this classification system. Previous discussions have generally neglected to articulate guidelines for appropriate use of racial/ethnic information in etiologic research. The authors summarize the logical, conceptual, and practical problems associated with the "ethnic paradigm" as currently applied in biomedical sciences and offer a set of methodological recommendations toward more valid use of racial/ethnic classification in etiologic studies. These suggested guidelines address issues of variable definition, study design, and covariate control, providing a consistent foundation for etiologic research programs that neither ignore racial/ethnic disease disparities nor obfuscate the nature of these disparities through inappropriate analytical approaches. This methodological analysis of racial/ethnic classification as an epidemiologic quantity provides a formal basis for a focus on racism (i.e., social relations) rather than race (i.e., innate biologic predisposition) in the interpretation of racial/ethnic "effects."     

Health Benefits Mandates and Their Potential Impacts on Racial/Ethnic Group Disparities in Insurance Markets

Addressing racial/ethnic group disparities in health insurance benefits through legislative mandates requires attention to the different proportions of racial/ethnic groups among insurance markets. This necessary baseline data, however, has proven difficult to measure. We applied racial/ethnic data from the 2009 California Health Interview Survey to the 2012 California Health Benefits Review Program Cost and Coverage Model to determine the racial/ethnic composition of ten health insurance market segments. We found disproportional representation of racial/ethnic groups by segment, thus affecting the health insurance impacts of benefit mandates. California’s Medicaid program is disproportionately Latino (60 % in Medi-Cal, compared to 39 % for the entire population), and the individual insurance market is disproportionately non-Latino white. Gender differences also exist. Mandates could unintentionally increase insurance coverage racial/ethnic disparities. Policymakers should consider the distribution of existing racial/ethnic disparities as criteria for legislative action on benefit mandates across health insurance markets.     

Strategies for Medicare health plans serving racial and ethnic minorities

The Medicare Managed Care (MMC) Consumer Assessment of Health Plans Study (CAHPS) survey offers an opportunity to examine differences in health plan experiences and patterns of use of services of racial and ethnic minority beneficiaries enrolled in health plans. Analysis of the survey data and review of prior literature indicate significant health disparities and different patterns of health care use by racial and ethnic minorities. Improved measurement of health plan performance in serving minority enrollees, and development of performance improvement strategies, could have the potential to reduce the observed health disparities.     

Medicare managed care and primary care quality: examining racial/ethnic effects across states

The study assesses the role of Medicare Advantage (MA) plans in providing quality primary care in comparison to FFS Medicare in three states, New York, California, Florida, across three racial ethnic groups. The performance is measured in terms of providing better quality primary care, as defined by lowering the risks of preventable hospital admissions. Using 2004 hospital discharge data (HCUP-SID) of Agency for Healthcare Research and Quality for three states, a multivariate cross sectional design is used with individual admission as the unit of analysis. The study found that MA plans were associated with lower preventable hospitalizations relative to marker admissions. The benefit also spilled over to different racial and ethnic subgroups and in some states, e.g. CA and FL, MA enrollment was associated with significantly lower odds of minority admissions than of white admissions. These results may indicate a potentially favorable role of MA plans in attenuating racial/ethnic inequalities in primary care in some states.     

Challenges in understanding disparities in drug use and its consequences

Racial/ethnic disparities in health have long been documented in a broad range of medical conditions in the United States. For example, Blacks have higher HIV incidence and AIDS-related mortality than do Whites., This article summarizes racial/ethnic differences in drug use and its consequences in the United States and proposes three key challenges to the study of disparities in drug use and its consequences. These are (a) patterns of drug use and misuse are complex, with different patterns of use of different drugs in different racia,/ethnic groups; (b) racial/ethnic differnces in use of drugs are not always associated with comparable differences in the consequences of drug use; and (c) the consequences of drug use are associated with drug use itself and other social/economic circumstances. Each of these challenges is discussed, and suggestions offered for future research that may help overcome them.     

Racial differences in factors that influence the willingness to participate in medical research studies

PURPOSE: The relative absence of racial/ethnic minorities among medical research subjects is receiving considerable attention because of recent government mandates for their inclusion in all human subject research. We examined racial differences in the prevalence of sociocultural barriers as a possible explanation for the underrepresentation of African Americans in medical research studies. METHODS: During 1998-1999, a total of 198 residents of the Detroit Primary Metropolitan Statistical Area (PMSA) participated in a survey that examined impediments to participation in medical research studies. Chi square tests and logistic regression analyses were used to examine the association between race, issues related to trust of medical researchers, and the willingness to participate in medical research studies. RESULTS: Study results indicate that African Americans and whites differ in their willingness to participate in medical research. Racial differences in the willingness to participate in a medical research are primarily due to the lower level of trust of medical research among African Americans. African American respondents were also somewhat less willing to participate if they attribute high importance to the race of the doctor when seeking routine medical care, believed that minorities bear most of the risks of medical research, and if their knowledge of the Tuskegee Study resulted in less trust in medical researchers. CONCLUSION: These data reiterate the need for medical researchers to build trusting relationships with minority communities. Researchers can begin by acknowledging the previous medical abuse of minority research participants, discussing their specific plans to assure the protection of study participants, and explaining the need for the participation of racial/ethnic minorities including studies that specifically target or that are likely to result in disproportionate representation of racial/ethnic minorities among study participants.