Increasing trust in real-world evidence through evaluation of observational data quality

ObjectiveAdvances in standardization of observational healthcare data have enabled methodological breakthroughs, rapid global collaboration, and generation of real-world evidence to improve patient outcomes. Standardizations in data structure, such as use of common data models, need to be coupled with standardized approaches for data quality assessment. To ensure confidence in real-world evidence generated from the analysis of real-world data, one must first have confidence in the data itself. Materials and MethodsWe describe the implementation of check types across a data quality framework of conformance, completeness, plausibility, with both verification and validation. We illustrate how data quality checks, paired with decision thresholds, can be configured to customize data quality reporting across a range of observational health data sources. We discuss how data quality reporting can become part of the overall real-world evidence generation and dissemination process to promote transparency and build confidence in the resulting output.ResultsThe Data Quality Dashboard is an open-source R package that reports potential quality issues in an OMOP CDM instance through the systematic execution and summarization of over 3300 configurable data quality checks.DiscussionTransparently communicating how well common data model-standardized databases adhere to a set of quality measures adds a crucial piece that is currently missing from observational research.ConclusionAssessing and improving the quality of our data will inherently improve the quality of the evidence we generate.     

A scoping review of qualitative research in JAMIA: past contributions and opportunities for future work

ObjectiveQualitative methods are particularly well-suited to studying the complexities and contingencies that emerge in the development, preparation, and implementation of technological interventions in real-world clinical practice, and much remains to be done to use these methods to their full advantage. We aimed to analyze how qualitative methods have been used in health informatics research, focusing on objectives, populations studied, data collection, analysis methods, and fields of analytical origin.MethodsWe conducted a scoping review of original, qualitative empirical research in JAMIA from its inception in 1994 to 2019. We queried PubMed to identify relevant articles, ultimately including and extracting data from 158 articles.ResultsThe proportion of qualitative studies increased over time, constituting 4.2% of articles published in JAMIA overall. Studies overwhelmingly used interviews, observations, grounded theory, and thematic analysis. These articles used qualitative methods to analyze health informatics systems before, after, and separate from deployment. Providers have typically been the main focus of studies, but there has been an upward trend of articles focusing on healthcare consumers.DiscussionWhile there has been a rich tradition of qualitative inquiry in JAMIA, its scope has been limited when compared with the range of qualitative methods used in other technology-oriented fields, such as human–computer interaction, computer-supported cooperative work, and science and technology studies.ConclusionWe recommend increased public funding for and adoption of a broader variety of qualitative methods by scholars, practitioners, and policy makers and an expansion of the variety of participants studied. This should lead to systems that are more responsive to practical needs, improving usability, safety, and outcomes.     

A digital health profile & maturity assessment toolkit: cocreation and testing in the Pacific Islands

IntroductionCountries need to determine their level of digital health capability maturity to assess and mobilize their knowledge, skills, and resources to systematically develop, implement, evaluate, scale up and maintain large-scale implementations of standards-based interoperable digital health tools.ObjectiveDevelop a Digital Health Profile and Maturity Assessment Toolkit (DHPMAT) to assist Pacific Island Countries (PICs) to harness digital tools to support national health priorities.Materials and MethodsA literature review guided the development of the conceptual framework to underpin the DHPMAT. Key informants collaborated to collect key digital health features and indicators to inform their country’s digital health maturity assessment. The DHPMAT was tested with country stakeholders at a Pacific Health Information Network workshop in 2019.ResultsA comprehensive list of indicators to describe country digital health profiles (DHP). A digital health maturity assessment tool that uses criteria codeveloped with country stakeholders to assess essential digital health foundations and quality improvement. DHPs created and maturity assessed and packaged into individualized DHPMATs for 13 PICs. PIC users perceived the DHPMAT as useful, especially the congruence with the 2017 WHO WPRO Regional Strategy but noted a “cognitive overload” from a plethora of complex digital health toolkits.ConclusionsThe cocreation approach optimized currency, accuracy, and appropriateness of information in the DHP, understanding, and use of the DHPMAT to facilitate informed iterative discussion by PICs on their digital health maturity to harness digital tools to strengthen country health systems. The DHPMAT can rationalize the choice and use of existing tools and reduce cognitive overload.     

Sharing patient-generated data with healthcare providers: findings from a 2019 national survey

ObjectiveOur study estimates the prevalence and predictors of wearable device adoption and data sharing with healthcare providers in a nationally representative sample.Materials and MethodsData were obtained from the 2019 Health Information National Trend Survey. We conducted multivariable logistic regression to examine predictors of device adoption and data sharing.ResultsThe sample contained 4159 individuals, 29.9% of whom had adopted a wearable device in 2019. Among adopters, 46.3% had shared data with their provider. Individuals with diabetes (odds ratio [OR], 2.39; 95% CI, 1.66–3.45; P < .0001), hypertension (OR, 2.80; 95% CI, 2.12–3.70; P < .0001), and multiple chronic conditions (OR, 1.55; 95% CI, 1.03–2.32; P < .0001) had significantly higher odds of wearable device adoption. Individuals with a usual source of care (OR, 2.44; 95% CI, 1.95–3.04; P < .0001), diabetes (OR, 1.66; 95% CI, 1.32–2.08; P < .0001), and hypertension (OR, 1.78; 95% CI, 1.44–2.20; P < .0001) had significantly higher odds of sharing data with providers.DiscussionA third of individuals adopted a wearable medical device and nearly 50% of individuals who owned a device shared data with a provider in 2019. Patients with certain conditions, such as diabetes and hypertension, were more likely to adopt devices and share data with providers. Social determinants of health, such as income and usual source of care, negatively affected wearable device adoption and data sharing, similarly to other consumer health technologies.ConclusionsWearable device adoption and data sharing with providers may be more common than prior studies have reported; however, digital disparities were noted. Studies are needed that test implementation strategies to expand wearable device use and data sharing into care delivery.     

Catheter ablation of complex cardiac arrhythmias: Single-centre experience in Armed Forces

BackgroundComplex arrhythmia ablation remains a technical challenge despite advances in hardware and mapping techniques. The aim of the study was to analyse the efficacy of radiofrequency ablation of arrhythmias requiring complex electrophysiological procedures at a tertiary-care centre.MethodsA retrospective study was done for catheter ablation of arrhythmias performed at a single centre from Aug 2012 to Nov 2016 (4 years 4 months). The standard ablation involved conventional catheters with antegrade right heart and retrograde left heart access. The procedure was considered complex, if it involved 3 D electro-anatomical (EA) guidance for mapping or required special hardware and/or trans-septal puncture.ResultsOf 333 electrophysiology (EP) cases 265 qualified for ablation. The cohort of arrhythmias requiring complex procedure (n = 94) comprised of supraventricular 15 (15.9%), atrioventricular 43 (44.7%) and ventricular 36 (38.3%). The procedure used three-dimensional EA mapping in 31; trans-septal puncture for left atrial access in 40; and use of special catheters and sheaths in all 94 procedures. The overall success in the complex group after the first procedure was 87.2% versus 88.3% (P < 0.05), and after redo procedure it was 90.4% vs 94.7% (P < 0.05). There were three complications (pericardial perforation: 2; cardioembolism: 1) only in the complex group. The fluoroscopy time for complex was longer than that of the standard procedure (25.10 ± 6.32 versus 15.23 ± 5.33 min, P = 2.54).ConclusionArrhythmias requiring complex electrophysiological procedure for ablation have a comparable success rate to standard ablation procedure but at the cost of extra hardware, complications and fluoroscopy time.     

The Mass General Brigham Biobank Portal: an i2b2-based data repository linking disparate and high-dimensional patient data to support multimodal analytics

ObjectiveIntegrating and harmonizing disparate patient data sources into one consolidated data portal enables researchers to conduct analysis efficiently and effectively.Materials and MethodsWe describe an implementation of Informatics for Integrating Biology and the Bedside (i2b2) to create the Mass General Brigham (MGB) Biobank Portal data repository. The repository integrates data from primary and curated data sources and is updated weekly. The data are made readily available to investigators in a data portal where they can easily construct and export customized datasets for analysis.ResultsAs of July 2021, there are 125 645 consented patients enrolled in the MGB Biobank. 88 527 (70.5%) have a biospecimen, 55 121 (43.9%) have completed the health information survey, 43 552 (34.7%) have genomic data and 124 760 (99.3%) have EHR data. Twenty machine learning computed phenotypes are calculated on a weekly basis. There are currently 1220 active investigators who have run 58 793 patient queries and exported 10 257 analysis files.DiscussionThe Biobank Portal allows noninformatics researchers to conduct study feasibility by querying across many data sources and then extract data that are most useful to them for clinical studies. While institutions require substantial informatics resources to establish and maintain integrated data repositories, they yield significant research value to a wide range of investigators.ConclusionThe Biobank Portal and other patient data portals that integrate complex and simple datasets enable diverse research use cases. i2b2 tools to implement these registries and make the data interoperable are open source and freely available.     

The Informatics Opportunities at the Intersection of Patient Safety and Clinical Informatics

Health care providers have a basic responsibility to protect patients from accidental harm. At the institutional level, creating safe health care organizations necessitates a systematic approach. Effective use of informatics to enhance safety requires the establishment and use of standards for concept definitions and for data exchange, development of acceptable models for knowledge representation, incentives for adoption of electronic health records, support for adverse event detection and reporting, and greater investment in research at the intersection of informatics and patient safety. Leading organizations have demonstrated that health care informatics approaches can improve safety. Nevertheless, significant obstacles today limit optimal application of health informatics to safety within most provider environments. The authors offer a series of recommendations for addressing these challenges.This position paper focuses on next steps in using health informatics to improve patient safety. The paper does not attempt to provide a comprehensive review of patient safety-related technical accomplishments, because recent Institute of Medicine (IOM) reports have done so. This paper focuses instead on current pressing issues and opportunities for addressing them in the short-term future. The intended audience includes provider organizations responsible for the safe delivery of health care; policy makers responsible for funding and regulatory decisions that influence health care safety, and the health informatics developers community (including vendors) who build the computer systems that support patient care.     

Confidential health care for adolescents: reconciling clinical evidence with family values

Community debate about confidential health care for adolescents was triggered recently by the federal government's proposal to allow parents of teenagers aged 16 years and under access to their children's Health Insurance Commission data without their consent. Extensive research evidence highlights the importance of confidentiality in promoting young people's access to health care, particularly for sensitive issues such as mental and sexual health, and substance use. Involving parents is important, but evidence for any benefit from mandatory parental involvement is lacking. The law recognises the rights of mature minors to make decisions about their medical treatment and to receive confidential health care; however, the doctor must weigh up certain factors to assess maturity and ensure that confidentiality around such treatment will be in the young person's best interests. Evaluation of maturity must take into account characteristics of the young person, gravity of the proposed treatment, family factors, and statutory restrictions.     

国外医学信息学领域研究前沿

利用BICOMB、VOSviewer、SPSS等分析软件,以PubMed数据库中医学信息学领域核心期刊2010-2014年的科技文献为数据来源,绘制共现网络图、热点密度图和聚类树图,探测国外医学信息学领域研究前沿,研究显示国外医学信息学领域的研究前沿主要包括电子健康档案的自然语言处理和数据挖掘,医疗决策帮助系统,计算机辅助的药物治疗,临床决策支持,医疗保健的态度、质量和模式,病案系统及其联动,信息系统及其整合等。     

The role of medical informatics in telemedicine

The role of medical informatics in telemedicine is dependent on using the power of the computerized database to not only feed patient specific information to the health care providers, but to use the epidemiological and statistical information in the data base to improve decision making and ultimately care. The computer is also a powerful tool to facilitate standardizing and monitoring of care and when applied in continuous quality improvement methodology it can enhance the improvement process well beyond what can be done by hand. The coupling of medical informatics with telemedicine allows sophisticated medical informatics systems to be applied in low population density and remote areas.     

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.     

Current Issues in Health Care Informatics

Health care informatics has emerged as a diverse and important new field of study. The field can be very broadly defined as the science that addresses how best to use information to improve health care. The field includes the four areas of bioinformatics, medical informatics, public health informatics, and consumer health informatics. Health care informatics applications can be used to improve the quality of patient care, to increase productivity, and to provide access to knowledge. After providing an overview of the field, the 10 articles contained in this special issue are briefly discussed. The first six articles address a diverse set of topics such as the use of health care informatics to conduct research, clinical information systems used by the U.S. Air Force, electronic medical records and physician satisfaction in Oman, and a point of care documentation system used by hospice care providers. The last four articles discuss the complex issues raised by the implementation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).     

Nonpalpable intrauterine device threads: Is it a cause for worry?

BackgroundIntrauterine contraceptive device is a popular and effective method of contraception. It can be inserted either as an interval procedure or after abortion or delivery. Threads are attached to the vertical limb so that the user can find out the location of the device. Sometimes the threads are not palpable by the user; this study was conducted to find out the reasons for inability to palpate the threads.Methods and resultsThe retrospective study was conducted over a period of eight years; 110 female patients who complained of inability to feel the threads were included in the study. In most of the cases the device was in the right place. In four cases the device could not be felt on uterine sounding; this could have been due to subendometrial placement of the device. There was no case of perforation by the device.ConclusionInability to feel the threads is a common complaint by the patients who are using intrauterine contraceptive device. In most of the cases the device was in correct position and could be localized by clinical examination. Ultrasonography can help in localization of the device; if used at the time of insertion it can confirm proper insertion and location of the device. This will reassure the client and the health care providers.     

The Triangle Model for evaluating the effect of health information technology on healthcare quality and safety

With the proliferation of relatively mature health information technology (IT) systems with large numbers of users, it becomes increasingly important to evaluate the effect of these systems on the quality and safety of healthcare. Previous research on the effectiveness of health IT has had mixed results, which may be in part attributable to the evaluation frameworks used. The authors propose a model for evaluation, the Triangle Model, developed for designing studies of quality and safety outcomes of health IT. This model identifies structure-level predictors, including characteristics of: (1) the technology itself; (2) the provider using the technology; (3) the organizational setting; and (4) the patient population. In addition, the model outlines process predictors, including (1) usage of the technology, (2) organizational support for and customization of the technology, and (3) organizational policies and procedures about quality and safety. The Triangle Model specifies the variables to be measured, but is flexible enough to accommodate both qualitative and quantitative approaches to capturing them. The authors illustrate this model, which integrates perspectives from both health services research and biomedical informatics, with examples from evaluations of electronic prescribing, but it is also applicable to a variety of types of health IT systems.     

Guideposts to the Future—An Agenda for Nursing Informatics

As new directions and priorities emerge in health care, nursing informatics leaders must prepare to guide the profession appropriately. To use an analogy, where a road bends or changes directions, guideposts indicate how drivers can stay on course. The AMIA Nursing Informatics Working Group (NIWG) produced this white paper as the product of a meeting convened: 1) to describe anticipated nationwide changes in demographics, health care quality, and health care informatics; 2) to assess the potential impact of genomic medicine and of new threats to society; 3) to align AMIA NIWG resources with emerging priorities; and 4) to identify guideposts in the form of an agenda to keep the NIWG on course in light of new opportunities. The anticipated societal changes provide opportunities for nursing informatics. Resources described below within the Department of Health and Human Services (HHS) and the National Committee for Health and Vital Statistics (NCVHS) can help to align AMIA NIWG with emerging priorities. The guideposts consist of priority areas for action in informatics, nursing education, and research. Nursing informatics professionals will collaborate as full participants in local, national, and international efforts related to the guideposts in order to make significant contributions that empower patients and providers for safer health care.     

微波止血分离器联合微波消融在腹腔镜外生型血管瘤治疗中的应用

目的 探讨微波止血分离器在腹腔镜外生型血管瘤微波消融中应用的疗效和安全性.方法 回顾性分析2015年5月至2017年5月在该院进行微波消融的62例外生型血管瘤患者的临床资料.根据术中治疗方式的不同分为微波止血分离器联合微波消融组(联合组,29例)和单纯微波消融组(微波组,33例),微波组在腹腔镜下直接行肝血管瘤微波消融,联合组在腹腔镜下先使用微波止血分离器行血管瘤表面固化,再行微波消融.观察患者术中及术后情况.结果 所有患者均在腹腔镜下顺利完成手术,无中转开腹,联合组微波消融时间[(10.69±3.54)min]低于微波组[(13.18±4.31)min,P＜0.05].联合组[(48.79±20.30)mL]低于微波组[(95.76±90.16)mL,P＜0.05].两组患者术后均顺利恢复,无腹腔出血、胆漏等并发症.结论 肝外生型血管瘤进行微波穿刺消融前,使用微波止血分离器进行瘤体表面固化,可提高手术安全性,减少消融所需时间,避免穿刺引起的瘤体出血.     

Gender representation in U.S. biomedical informatics leadership and recognition

ObjectiveThis study sought to describe gender representation in leadership and recognition within the U.S. biomedical informatics community.Materials and MethodsData were collected from public websites or provided by American Medical Informatics Association (AMIA) personnel from 2017 to 2019, including gender of membership, directors of academic informatics programs, clinical informatics subspecialty fellowships, AMIA leadership (2014-2019), and AMIA awardees (1993-2019). Differences in gender proportions were calculated using chi-square tests.ResultsMen were more often in leadership positions and award recipients (P < .01). Men led 74.7% (n = 71 of 95) of academic informatics programs and 83.3% (n = 35 of 42) of clinical informatics fellowships. Within AMIA, men held 56.8% (n = 1086 of 1913) of leadership roles and received 64.1% (n = 59 of 92) of awards.DiscussionAs in other STEM fields, leadership and recognition in biomedical informatics is lower for women.ConclusionsQuantifying gender inequity should inform data-driven strategies to foster diversity and inclusion. Standardized collection and surveillance of demographic data within biomedical informatics is necessary.     

A research agenda to support the development and implementation of genomics-based clinical informatics tools and resources

ObjectiveThe Genomic Medicine Working Group of the National Advisory Council for Human Genome Research virtually hosted its 13th genomic medicine meeting titled “Developing a Clinical Genomic Informatics Research Agenda”. The meeting’s goal was to articulate a research strategy to develop Genomics-based Clinical Informatics Tools and Resources (GCIT) to improve the detection, treatment, and reporting of genetic disorders in clinical settings.Materials and MethodsExperts from government agencies, the private sector, and academia in genomic medicine and clinical informatics were invited to address the meeting''s goals. Invitees were also asked to complete a survey to assess important considerations needed to develop a genomic-based clinical informatics research strategy.ResultsOutcomes from the meeting included identifying short-term research needs, such as designing and implementing standards-based interfaces between laboratory information systems and electronic health records, as well as long-term projects, such as identifying and addressing barriers related to the establishment and implementation of genomic data exchange systems that, in turn, the research community could help address.DiscussionDiscussions centered on identifying gaps and barriers that impede the use of GCIT in genomic medicine. Emergent themes from the meeting included developing an implementation science framework, defining a value proposition for all stakeholders, fostering engagement with patients and partners to develop applications under patient control, promoting the use of relevant clinical workflows in research, and lowering related barriers to regulatory processes. Another key theme was recognizing pervasive biases in data and information systems, algorithms, access, value, and knowledge repositories and identifying ways to resolve them.     

Three Decades of Research on Computer Applications in Health Care: Medical Informatics Support at the Agency for Healthcare Research and Quality

The Agency for Healthcare Research and Quality and its predecessor organizations—collectively referred to here as AHRQ—have a productive history of funding research and development in the field of medical informatics, with grant investments since 1968 totaling $107 million. Many computerized interventions that are commonplace today, such as drug interaction alerts, had their genesis in early AHRQ initiatives.This review provides a historical perspective on AHRQ investment in medical informatics research. It shows that grants provided by AHRQ resulted in achievements that include advancing automation in the clinical laboratory and radiology, assisting in technology development (computer languages, software, and hardware), evaluating the effectiveness of computer-based medical information systems, facilitating the evolution of computer-aided decision making, promoting computer-initiated quality assurance programs, backing the formation and application of comprehensive data banks, enhancing the management of specific conditions such as HIV infection, and supporting health data coding and standards initiatives.Other federal agencies and private organizations have also supported research in medical informatics, some earlier and to a greater degree than AHRQ. The results and relative roles of these related efforts are beyond the scope of this review.Three decades ago, when the federal government''s National Center for Health Services Research and Development began to support research on computer applications in health care, few imagined the impact that information systems and sciences would have on medical care today. For most, the idea of a national clearinghouse of guidelines, available through a computer that sits on a home office desktop, seemed like science fiction. For a few researchers and those supporting their work, however, visions of what could become possible in the management of health care information called for development of computerized systems and the evaluation of their effects on quality, cost, and access to care.The Agency for Healthcare Research and Quality (AHRQ, from 1999) and its predecessor agencies—the National Center for Health Services Research and Development (beginning in 1968) and the Agency for Health Care Policy and Research (from 1989 to 1999)—have a rich history of funding research, development, and evaluation in medical informatics. Although the grant investments since 1968 total only $107 million ($246 million in 2000 dollars), they supported initiatives that have established a research framework for many of the computer applications now being used today.The focus of AHRQ''s early research funding in medical informatics was on acquiring patient care data and communicating patient care management information. The goal was not only to improve the quality of care, but also to achieve reductions in costs and medical personnel resource use by processing data more efficiently. Research aimed at improving communication of information was targeted at what we would call today “getting the right information to the right place at the right time.” The promise of this research was its ability to provide findings that would guide reorganization of care delivery, take advantage of the more rapid communication of necessary information, and reduce manpower needs.¹ Over time, AHRQ''s funding has emphasized the application of health services research methods to evaluations of information technology used in community health settings. This article highlights key accomplishments emerging from AHRQ''s funding that have improved the quality of patient care in studied sites and have the potential to improve health care in all settings.Other federal agencies (such as the National Library of Medicine, the Veterans Health Administration, and the Department of Defense) and private organizations (such as The John A. Hartford Foundation, The Robert Wood Johnson Foundation, and the American Hospital Association) have supported developments in medical informatics, with some having greater research expenditures and earlier histories than AHRQ. Nevertheless, it is the Agency''s contributions to medical informatics that are the focus of this study. The purpose of this article is to provide a historical perspective for understanding the benefits of past research funded by AHRQ that supports health care applications of information technology today and that foreshadows AHRQ''s medical informatics initiatives for the future.