中医临床研究数据中心构建模式探讨

为促进中医药事业发展,创新中医临床科研模式,实现中医临床研究数据共享,为广大医护、研究人员提供海量信息支撑,构建中医临床研究数据中心是实现创新型中医临床研究的重要手段之一。对中医临床研究数据中心构建模式进行了探讨,从中医临床研究数据的分层管理模式出发,阐述了国家数据中心与医院数据中心的关系;介绍了医院数据中心的构建方式,并探讨医院数据中心与医院信息中心的数据交互方式,以及协作单位的数据整合方式等;通过国家与医院数据中心的互联,实现了中医临床研究数据跨区域共享：通过对数据存取流程的分析,阐述了中医临床数据中心数据的传输方式。     

Responses by four Local Research Ethics Committees to submitted proposals.

BACKGROUND: There is relatively little research concerning the processes whereby Local Research Ethics Committees discharge their responsibilities towards society, potential participants and investigators. OBJECTIVES: To examine the criteria used by LRECs in arriving at their decisions concerning approval of research protocols through an analysis of letters sent to investigators. DESIGN: Four LRECs each provided copies of 50 letters sent to investigators after their submitted proposals had been considered by the committees. These letters were subjected to a content analysis, in which specific comments and requests for additional information and changes in the protocols were recorded and compared. FINDINGS: Overall 24% of proposals were approved without request for changes or clarifications, but this varied by committee: one committee approved only 6% of proposals without change or clarification while the others ranged from 26% to 32%. The content analyses of responses indicated that they could be placed into four categories: (i) further information for the committee to aid in their deliberations; (ii) requests for changes to the design or justification for the design used; (iii) changes to the information sheets provided to potential participants; and (iv) changes to consent procedures. Of these, alterations to information sheets were the most common type of request. These four types of response could be seen as safeguarding the wellbeing of potential participants (the principle of non-maleficence), of promoting the scientific validity of the research (the principle of beneficence), and of enhancing the rights of potential participants (the principle of autonomy). CONCLUSIONS: The committees were consistent in the types of requests they made of investigators, which can be seen as attempts to protect participants' rights and ensure the scientific validity of studies. Without an analysis of the proposals sent to the committees, however, it is difficult to account for the variation in the requirements set by the committees before approval was given.     

Protecting the privacy of family members in survey and pedigree research

The recent controversy at Virginia Commonwealth University involving research ethics raises important and complex issues in survey and pedigree research. The primary questions are whether family members of survey respondents themselves become subjects of the project and if they are subjects whether informed consent must be obtained for investigators to retain private information on these individuals. This article provides an analysis of the ethical issues and regulatory standards involved in this debate for consideration by investigators and institutional review boards. The analysis suggests that strong protections for the rights and welfare of subjects and their family members can be incorporated into survey and pedigree research protocols without hindering projects with extensive consent requirements.     

An architecture for research computing in health to support clinical and translational investigators with electronic patient data

ObjectiveObtaining electronic patient data, especially from electronic health record (EHR) systems, for clinical and translational research is difficult. Multiple research informatics systems exist but navigating the numerous applications can be challenging for scientists. This article describes Architecture for Research Computing in Health (ARCH), our institution’s approach for matching investigators with tools and services for obtaining electronic patient data.Materials and MethodsSupporting the spectrum of studies from populations to individuals, ARCH delivers a breadth of scientific functions—including but not limited to cohort discovery, electronic data capture, and multi-institutional data sharing—that manifest in specific systems—such as i2b2, REDCap, and PCORnet. Through a consultative process, ARCH staff align investigators with tools with respect to study design, data sources, and cost. Although most ARCH services are available free of charge, advanced engagements require fee for service.ResultsSince 2016 at Weill Cornell Medicine, ARCH has supported over 1200 unique investigators through more than 4177 consultations. Notably, ARCH infrastructure enabled critical coronavirus disease 2019 response activities for research and patient care.DiscussionARCH has provided a technical, regulatory, financial, and educational framework to support the biomedical research enterprise with electronic patient data. Collaboration among informaticians, biostatisticians, and clinicians has been critical to rapid generation and analysis of EHR data.ConclusionA suite of tools and services, ARCH helps match investigators with informatics systems to reduce time to science. ARCH has facilitated research at Weill Cornell Medicine and may provide a model for informatics and research leaders to support scientists elsewhere.     

Brief communication: Developing a data infrastructure for a learning health system: the PORTAL network

The Kaiser Permanente & Strategic Partners Patient Outcomes Research To Advance Learning (PORTAL) network engages four healthcare delivery systems (Kaiser Permanente, Group Health Cooperative, HealthPartners, and Denver Health) and their affiliated research centers to create a new national network infrastructure that builds on existing relationships among these institutions. PORTAL is enhancing its current capabilities by expanding the scope of the common data model, paying particular attention to incorporating patient-reported data more systematically, implementing new multi-site data governance procedures, and integrating the PCORnet PopMedNet platform across our research centers. PORTAL is partnering with clinical research and patient experts to create cohorts of patients with a common diagnosis (colorectal cancer), a rare diagnosis (adolescents and adults with severe congenital heart disease), and adults who are overweight or obese, including those with pre-diabetes or diabetes, to conduct large-scale observational comparative effectiveness research and pragmatic clinical trials across diverse clinical care settings.     

Four years of replacing ailing hearts: surgeons assess data, questions remain

The author reviews the clinical course of those patients in the United States who have received permanent or temporary artificial hearts and presents their physicians' assessments of the failures and successes of the devices. Several transplant surgeons offer their opinions on the controversial issue of the prioritization in selection for a human heart transplant of patients maintained on a temporary artificial heart (bridge-to-transplantation) and on the Food and Drug Administration's criteria for centers permitted to use the bridge-to-transplantation procedure. Cole concludes that, despite the optimism of some investigators, the risks associated with either temporary or permanent artificial hearts may be too great to justify further use. Still unanswered are the public policy issues of payment for these programs and of equitable allocation of donor organs.     

The stipulations of one institutional review board: a five year review

OBJECTIVES: This study was designed to explore the prevalence and types of stipulations (such as clarifications or changes) required of investigators by the institutional review board (IRB) of one institution over a five year period. DESIGN: Stipulations to research proposals (n = 124) were documented from the minutes of the IRB meetings. SETTING: Community hospital. PARTICIPANTS: IRB submissions. Main measurements: Number and type of IRB stipulations. RESULTS: Nineteen research submissions (15.3%) were approved without any stipulations. For the remainder, the majority of stipulations related to consent forms (74.2%). CONCLUSIONS: Consent forms appear to be at highest risk for IRB stipulations. Being aware of high risk areas before submission of research proposals may reduce the frequency of stipulations required of investigators.     

Three cases of illness during a drug trial in healthy volunteers

During a double blind, randomized drug trial involving healthy, paid volunteers, three of the subjects developed an illness compatible with a diagnosis of serum sickness or of a viral illness. The double blind code was broken, the trial suspended, and an investigation begun, even though no other reactions had been reported from other trial centers. After the investigation revealed that a communicable viral infection was the probable cause of the illnesses, the trial was resumed and completed without ill effect. The authors conclude that healthy volunteers who become sick during a drug trial should be investigated by an informed physician not involved in the trial and that investigators must maintain a high index of suspicion for untoward effects.     

Brief communication: The ADVANCE network: accelerating data value across a national community health center network

The ADVANCE (Accelerating Data Value Across a National Community Health Center Network) clinical data research network (CDRN) is led by the OCHIN Community Health Information Network in partnership with Health Choice Network and Fenway Health. The ADVANCE CDRN will ‘horizontally’ integrate outpatient electronic health record data for over one million federally qualified health center patients, and ‘vertically’ integrate hospital, health plan, and community data for these patients, often under-represented in research studies. Patient investigators, community investigators, and academic investigators with diverse expertise will work together to meet project goals related to data integration, patient engagement and recruitment, and the development of streamlined regulatory policies. By enhancing the data and research infrastructure of participating organizations, the ADVANCE CDRN will serve as a ‘community laboratory’ for including disadvantaged and vulnerable patients in patient-centered outcomes research that is aligned with the priorities of patients, clinics, and communities in our network.     

Informed consent for research: international perspectives

Problems in obtaining and documenting informed consent are especially difficult to resolve in countries whose cultures differ considerably from those of most Western nations. Confusion between the research and therapeutic contexts are widespread. Two departures from widely accepted ethical standards are discussed: withholding information about the research and requiring a husband's permission for his wife to participate. Supporters of such departures claim that they are justified by the cultural context of the country in which the research is carried out. One program at the World Health Organization has developed guidelines stating that requiring partner agreement or authorization for an individual to participate in research violates the autonomy of research subjects and their right to confidentiality. A study carried out at one reproductive health clinic in Chile describes a process of obtaining informed consent to research that could serve as a model for US investigators interested in making informed consent a meaningful and ethically respectable aspect of their research activities. Research involving human subjects should adhere to a single, universally applicable standard of informed decision making by participants.     

The Shared Health Research Information Network (SHRINE): A Prototype Federated Query Tool for Clinical Data Repositories

The authors developed a prototype Shared Health Research Information Network (SHRINE) to identify the technical, regulatory, and political challenges of creating a federated query tool for clinical data repositories. Separate Institutional Review Boards (IRBs) at Harvard's three largest affiliated health centers approved use of their data, and the Harvard Medical School IRB approved building a Query Aggregator Interface that can simultaneously send queries to each hospital and display aggregate counts of the number of matching patients. Our experience creating three local repositories using the open source Informatics for Integrating Biology and the Bedside (i2b2) platform can be used as a road map for other institutions. The authors are actively working with the IRBs and regulatory groups to develop procedures that will ultimately allow investigators to obtain identified patient data and biomaterials through SHRINE. This will guide us in creating a future technical architecture that is scalable to a national level, compliant with ethical guidelines, and protective of the interests of the participating hospitals.     

Ethical dilemmas in malaria drug and vaccine trials: a bioethical perspective.

Malaria is a disease of developing countries whose local health services do not have the time, resources or personnel to mount studies of drugs or vaccines without the collaboration and technology of western investigators. This investigative collaboration requires a unique bridging of cultural differences with respect to human investigation. The following debate, sponsored by The Institute of Medicine and The American Society of Tropical Medicine and Hygiene, raises questions concerning the conduct of trans-cultural clinical malaria research. Specific questions are raised about the difficulties of informed consent in different cultural settings and whether there is any role for community involvement. Discussants debate whether drug and vaccine trials not approved in an industrialised country are ever defensible if performed in a third-world setting. Potential conflicting priorities between investigators are discussed and ideas regarding conflict resolution are offered.     

Discovering Blood Donor Arrival Patterns Using Data Mining: A Method to Investigate Service Quality at Blood Centers

Blood centers without fixed appointments for collecting blood often experience nonconstant donor arrival rates, which vary due to time-of-day, day-of-week, etc. When a constant workforce size is employed in such blood centers, there is either idle personnel, or donor satisfaction is compromised due to long waiting times, or both conditions alternate over time. Consequently, a method to obtain adaptive workforce requirements might be valuable. This study utilized the Two-Step Cluster method and the Classification and Regression Trees method in succession to identify both daily and hourly donor arrival patterns at Hacettepe University Hospitals’ Blood Center. A serial queuing network model of the donation process was then employed for each of the identified donor arrival patterns. By considering and accomodating variations in the donor arrival patterns, required workforce sizes and their decomposition among process steps were predicted to achieve predetermined target values of expected waiting times and to balance workforce utilizations in the blood donation processes. Although a blood center is considered for the proposed methodology, the approach is general and applications in various operations of healthcare organizations are possible.     

江苏省农村卫生适宜技术基线资料调查的质量控制

＂农村卫生适宜技术及产品研究与应用＂是国家＂十一五＂科技支撑计划重大项目,旨在选择一批安全、有效、廉价、农民迫切需要的适宜卫生技术推广到基层医疗卫生机构中去,因此其基线资料调查过程中的质量控制至关重要,本文总结了江苏省课题组在本次调查过程中的经验,以为日后类似调查、数据录入中的质量控制提供参考依据。在调查前先确定调查方案,取得相关政府部门的支持配合,选择一批责任心强的在读硕士生和博士生为调查员并进行严格统一培训以保证取得准确、可靠的一线调查资料。调查实施阶段进行了小范围小样本的预调查,随后的现场调查须在征得被调查者的知情同意后进行,同时组织省级课题组巡视员进行巡视检查。调查结束进一步人工核查所得数据,数据录入采用双人双轨录入,录入完成后,对双份数据进行核对和逻辑一致性校验,最后再进行数据统计与分析。     

Clinical teaching reexamined.

In an effort to determine the most effective clinical teaching behaviors of clinical teachers or preceptors in individual or small group settings, investigators at the University of North Carolina and the University of Alabama developed an instrument to survey all clinical medical students at the two institutions. This process resulted in a compilation of the specific behaviors found to be most helpful to the responding students in facilitating their clinical learning. All items were then factor analyzed, resulting in six more general teaching dimensions or factors being identified. There were active student participation, preceptor attitude toward teaching, emphasis on applied problem-solving, a student-centered instructional strategy, humanistic orientation, and emphasis on content and research. The more specific behaviors which loaded on each factor were also examined.     

Rating authors' contributions to collaborative research: the PICNIC survey of university departments of pediatrics. Pediatric Investigators' Collaborative Network on Infections in Canada.

OBJECTIVES: To determine how department chairs in pediatrics rate involvement in medical research and to determine whether faculty deans' offices have written criteria for evaluating research activity when assessing candidates for promotion or tenure. DESIGN: Cross-sectional mailed survey and telephone survey. SETTING: Canadian faculties of medicine. PARTICIPANTS: Chairs of the 16 Canadian university departments of pediatrics and deans' offices of the 16 university medical faculties. MAIN OUTCOME MEASURE: Weight assigned by department chairs to contributions to published research according to author's research role and position in list of authors and the method of listing authors. RESULTS: Fifteen of 16 chairs responded. Twelve submitted a completed survey, two described their institutions' policies and one responded that the institution had no policy. Eleven reported that faculty members were permitted or requested to indicate research roles on curricula vitae. There was a consensus that all or principal investigators should be listed as authors and that citing the research group as collective author was insufficient. The contribution of first authors was rated highest for articles in which all or principal investigators were listed. The contribution of joint-principal investigators listed as first author was also given a high rating. In the case of collective authorship, the greatest contribution was credited to the principal investigator of the group. Participation of primary investigators in multicentre research was rated as having higher value than participation in single-centre research by seven respondents and as having equal value by four. Only one dean's office had explicit written criteria for evaluating authorship. CONCLUSIONS: Most departments of pediatrics and medical faculty dean's offices in Canadian universities have no criteria for assessing the type of contribution made to published research. In view of the trend to use multicentre settings for clinical trials, guidelines for weighting investigators' contributions are needed.     

鼻咽癌专病科研数据库建设与应用

目的:阐述鼻咽癌专病科研数据库建设过程中关于数据标准建设、多源异构数据整合、深度数据治理以及临床数据时序排列等的成效与经验.方法:鼻咽癌专病科研数据库建设过程中,通过梳理"肿瘤通用集、瘤种专科集"两个层次的数据标准,建立数据集-业务活动-数据来源对应关系实现多源异构数据整合,同步进行结构化数据的规范映射存储、文本数据的...     

The case for a new system for oversight of research on human subjects

The increasing emphasis on evidence-based clinical practice has thrown into sharp focus multiple deficiencies in current systems of ethical review. This paper argues that a complete overhaul of systems for ethical oversight of studies involving human subjects is now required as developments in medical, epidemiological and genetic research have outstripped existing structures for ethical supervision. It shows that many problems are now evident and concludes that sequential and piecemeal amendments to present arrangements are inadequate to address these. At their core present systems of ethical review still rely on the integrity and judgment of individual investigators. One possible alternative is to train and license research investigators, make explicit their responsibilities and have ethics committees devote much more of their time to monitoring research activity in order to detect those infringing the rules.     

Public attitudes towards the use of primary care patient record data in medical research without consent: a qualitative study

OBJECTIVES: Recent legislative changes within the United Kingdom have stimulated professional debate about access to patient data within research. However, there is currently little awareness of public views about such research. The authors sought to explore attitudes of the public, and their lay representatives, towards the use of primary care medical record data for research when patient consent was not being sought. METHODS: 49 members of the public and four non-medical members of local community health councils in South Wales, UK gave their views on the value and acceptability of three current research scenarios, each describing access to data without patient consent. RESULTS: Among focus group participants, awareness of research in primary care was low, and the appropriateness of general practitioners as researchers was questioned. There was general support for research but also concerns expressed about data collection without consent. These included lack of respect and patient control over the process. Unauthorised access to data by external agencies was a common fear. Current data collection practices, including population based disease registers elicited much anxiety. The key informants were equally critical of the scenarios and generally less accepting. CONCLUSIONS: This exploratory study has highlighted a number of areas of public concern when medical records are accessed for research without patient consent. Public acceptability regarding the use of medical records in research cannot simply be assumed. Further work is required to determine how widespread such views are and to inform those advising on confidentiality issues.     

When do we need clinical endpoint adjudication in clinical trials?

Abstract

Clinical endpoint adjudication (CEA) is a standardized process for assessment of safety and efficacy of pharmacologic or device therapies in clinical trials. CEA plays a key role in many large clinical trials with the aim of achieving consistency and accuracy of the study results, by applying independent and blinded evaluation of suspected clinical events reported by investigators. However, due to high costs there are different opinions regarding the use of central adjudication versus more simplified strategies or site-based assessments and whether the final results differ significantly. There is a lack of scientific evaluation of different adjudication strategies, and more knowledge is needed on the optimal adjudication process and how to achieve the best cost-effectiveness. New methodologies using national registry data and artificial intelligence may challenge the traditional adjudication strategy and could potentially reduce cost considerably with a similar result. Further research and evidence in this field of clinical trials methodology are essential.