Perspectives on the role of industry in informatics research and authorship.

OBJECTIVES: Advances in informatics research come from academic, nonprofit, and for-profit industry organizations, and from academic-industry partnerships. While scientific studies of commercial products may offer critical lessons for the field, manuscripts authored by industry scientists are sometimes categorically rejected. We review historical context, community perceptions, and guidelines on informatics authorship. PROCESS: We convened an expert panel at the American Medical Informatics Association 2022 Annual Symposium to explore the role of industry in informatics research and authorship with community input. The panel summarized session themes and prepared recommendations. CONCLUSIONS: Authorship for informatics research, regardless of affiliation, should be determined by International Committee of Medical Journal Editors uniform requirements for authorship. All authors meeting criteria should be included, and categorical rejection based on author affiliation is unethical. Informatics research should be evaluated based on its scientific rigor; all sources of bias and conflicts of interest should be addressed through disclosure and, when possible, methodological mitigation.

The Longitudinal Implementation Strategy Tracking System (LISTS): feasibility, usability, and pilot testing of a novel method.

BACKGROUND: Systematic approaches are needed to accurately characterize the dynamic use of implementation strategies and how they change over time. We describe the development and preliminary evaluation of the Longitudinal Implementation Strategy Tracking System (LISTS), a novel methodology to document and characterize implementation strategies use over time. METHODS: The development and initial evaluation of the LISTS method was conducted within the Improving the Management of SymPtoms during And following Cancer Treatment (IMPACT) Research Consortium (supported by funding provided through the NCI Cancer MoonshotSM). The IMPACT Consortium includes a coordinating center and three hybrid effectiveness-implementation studies testing routine symptom surveillance and integration of symptom management interventions in ambulatory oncology care settings. LISTS was created to increase the precision and reliability of dynamic changes in implementation strategy use over time. It includes three components: (1) a strategy assessment, (2) a data capture platform, and (3) a User's Guide. An iterative process between implementation researchers and practitioners was used to develop, pilot test, and refine the LISTS method prior to evaluating its use in three stepped-wedge trials within the IMPACT Consortium. The LISTS method was used with research and practice teams for approximately 12 months and subsequently we evaluated its feasibility, acceptability, and usability using established instruments and novel questions developed specifically for this study. RESULTS: Initial evaluation of LISTS indicates that it is a feasible and acceptable method, with content validity, for characterizing and tracking the use of implementation strategies over time. Users of LISTS highlighted several opportunities for improving the method for use in future and more diverse implementation studies. CONCLUSIONS: The LISTS method was developed collaboratively between researchers and practitioners to fill a research gap in systematically tracking implementation strategy use and modifications in research studies and other implementation efforts. Preliminary feedback from LISTS users indicate it is feasible and usable. Potential future developments include additional features, fewer data elements, and interoperability with alternative data entry platforms. LISTS offers a systematic method that encourages the use of common data elements to support data analysis across sites and synthesis across studies. Future research is needed to further adapt, refine, and evaluate the LISTS method in studies with employ diverse study designs and address varying delivery settings, health conditions, and intervention types.

Playing in the clinical decision support sandbox: tools and training for all.

Objectives: Introduce the CDS-Sandbox, a cloud-based virtual machine created to facilitate Clinical Decision Support (CDS) developers and implementers in the use of FHIR- and CQL-based open-source tools and technologies for building and testing CDS artifacts. Materials and Methods: The CDS-Sandbox includes components that enable workflows for authoring and testing CDS artifacts. Two workshops at the 2020 and 2021 AMIA Annual Symposia were conducted to demonstrate the use of the open-source CDS tools. Results: The CDS-Sandbox successfully integrated the use of open-source CDS tools. Both workshops were well attended. Participants demonstrated use and understanding of the workshop materials and provided positive feedback after the workshops. Discussion: The CDS-Sandbox and publicly available tutorial materials facilitated an understanding of the leading-edge open-source CDS infrastructure components. Conclusion: The CDS-Sandbox supports integrated use of the key CDS open-source tools that may be used to introduce CDS concepts and practice to the clinical informatics community.

A survey of computable biomedical knowledge repositories.

Introduction: While data repositories are well-established in clinical and research enterprises, knowledge repositories with shareable computable biomedical knowledge (CBK) are relatively new entities to the digital health ecosystem. Trustworthy knowledge repositories are necessary for learning health systems, but the policies, standards, and practices to promote trustworthy CBK artifacts and methods to share, and safely and effectively use them are not well studied. Methods: We conducted an online survey of 24 organizations in the United States known to be involved in the development or deployment of CBK. The aim of the survey was to assess the current policies and practices governing these repositories and to identify best practices. Descriptive statistics methods were applied to data from 13 responding organizations, to identify common practices and policies instantiating the TRUST principles of Transparency, Responsibility, User Focus, Sustainability, and Technology. Results: All 13 respondents indicated to different degrees adherence to policies that convey TRUST. Transparency is conveyed by having policies pertaining to provenance, credentialed contributors, and provision of metadata. Repositories provide knowledge in machine-readable formats, include implementation guidelines, and adhere to standards to convey Responsibility. Repositories report having Technology functions that enable end-users to verify, search, and filter for knowledge products. Less common TRUST practices are User Focused procedures that enable consumers to know about user licensing requirements or query the use of knowledge artifacts. Related to Sustainability, less than a majority post describe their sustainability plans. Few organizations publicly describe whether patients play any role in their decision-making. Conclusion: It is essential that knowledge repositories identify and apply a baseline set of criteria to lay a robust foundation for their trustworthiness leading to optimum uptake, and safe, reliable, and effective use to promote sharing of CBK. Identifying current practices suggests a set of desiderata for the CBK ecosystem in its continued evolution.

Patient-Facing Clinical Decision Support for High Blood Pressure Control: Patient Survey.

BACKGROUND: High blood pressure (HBP) affects nearly half of adults in the United States and is a major factor in heart attacks, strokes, kidney disease, and other morbidities. To reduce risk, guidelines for HBP contain more than 70 recommendations, including many related to patient behaviors, such as home monitoring and lifestyle changes. Thus, the patient's role in controlling HBP is crucial. Patient-facing clinical decision support (CDS) tools may help patients adhere to evidence-based care, but customization is required. OBJECTIVE: Our objective was to understand how to adapt CDS to best engage patients in controlling HBP. METHODS: We conducted a mixed methods study with two phases: (1) survey-guided interviews with a limited cohort and (2) a nationwide web-based survey. Participation in each phase was limited to adults aged between 18 and 85 years who had been diagnosed with hypertension. The survey included general questions that assessed goal setting, treatment priorities, medication load, comorbid conditions, satisfaction with blood pressure (BP) management, and attitudes toward CDS, and also a series of questions regarding A/B preferences using paired information displays to assess perceived trustworthiness of potential CDS user interface options. RESULTS: We conducted 17 survey-guided interviews to gather patient needs from CDS, then analyzed results and created a second survey of 519 adults with clinically diagnosed HBP. A large majority of participants reported that BP control was a high priority (83%), had monitored BP at home (82%), and felt comfortable using technology (88%). Survey respondents found displays with more detailed recommendations more trustworthy (56%-77% of them preferred simpler displays), especially when incorporating social trust and priorities from providers and patients like them, but had no differences in action taken. CONCLUSIONS: Respondents to the survey felt that CDS capabilities could help them with HBP control. The more detailed design options for BP display and recommendations messaging were considered the most trustworthy yet did not differentiate perceived actions.

Provider Perspectives on Patient- and Provider-Facing High Blood Pressure Clinical Decision Support.

BACKGROUND: Hypertension, persistent high blood pressures (HBP) leading to chronic physiologic changes, is a common condition that is a major predictor of heart attacks, strokes, and other conditions. Despite strong evidence, care teams and patients are inconsistently adherent to HBP guideline recommendations. Patient-facing clinical decision support (CDS) could help improve recommendation adherence but must also be acceptable to clinicians and patients. OBJECTIVE: This study aimed to partly address the challenge of developing a patient-facing CDS application, we sought to understand provider variations and rationales related to HBP guideline recommendations and perceptions regarding patient role and use of digital tools. METHODS: We engaged hypertension experts and primary care respondents to iteratively develop and implement a pilot survey and a final survey which presented five clinical cases that queried clinicians' attitudes related to actions; variations; prioritization; patient input; importance; and barriers for HBP diagnosis, monitoring, and treatment. Analysis of Likert's scale scores was descriptive with content analysis for free-text answers. RESULTS: Fifteen hypertension experts and 14 providers took the pilot and final version of the surveys, respectively. The majority (>80%) of providers felt the recommendations were important, yet found them difficult to follow-up to 90% of the time. Perceptions of relative amounts of patient input and patient work for effective HBP management ranged from 22 to 100%. Stated reasons for variation included adverse effects of treatment, patient comorbidities, shared decision-making, and health care cost and access issues. Providers were generally positive toward patient use of electronic CDS applications but worried about access to health care, nuance of recommendations, and patient understanding of the tools. CONCLUSION: At baseline, provider management of HBP is heterogeneous. Providers were accepting of patient-facing CDS but reported preferences for that CDS to capture the complexity and nuance of guideline recommendations.

Generating and Reporting Electronic Clinical Quality Measures from Electronic Health Records: Strategies from EvidenceNOW Cooperatives.

BACKGROUND: Electronic clinical quality measures (eCQMs) from electronic health records (EHRs) are a key component of quality improvement (QI) initiatives in small-to-medium size primary care practices, but using eCQMs for QI can be challenging. Organizational strategies are needed to effectively operationalize eCQMs for QI in these practice settings. OBJECTIVE: This study aimed to characterize strategies that seven regional cooperatives participating in the EvidenceNOW initiative developed to generate and report EHR-based eCQMs for QI in small-to-medium size practices. METHODS: A qualitative study comprised of 17 interviews with representatives from all seven EvidenceNOW cooperatives was conducted. Interviewees included administrators were with both strategic and cooperative-level operational responsibilities and external practice facilitators were with hands-on experience helping practices use EHRs and eCQMs. A subteam conducted 1-hour semistructured telephone interviews with administrators and practice facilitators, then analyzed interview transcripts using immersion crystallization. The analysis and a conceptual model were vetted and approved by the larger group of coauthors. RESULTS: Cooperative strategies consisted of efforts in four key domains. First, cooperative adaptation shaped overall strategies for calculating eCQMs whether using EHRs, a centralized source, or a "hybrid strategy" of the two. Second, the eCQM generation described how EHR data were extracted, validated, and reported for calculating eCQMs. Third, practice facilitation characterized how facilitators with backgrounds in health information technology (IT) delivered services and solutions for data capture and quality and practice support. Fourth, performance reporting strategies and tools informed QI efforts and how cooperatives could alter their approaches to eCQMs. CONCLUSION: Cooperatives ultimately generated and reported eCQMs using hybrid strategies because they determined neither EHRs alone nor centralized sources alone could operationalize eCQMs for QI. This required cooperatives to devise solutions and utilize resources that often are unavailable to typical small-to-medium-sized practices. The experiences from EvidenceNOW cooperatives provide insights into how organizations can plan for challenges and operationalize EHR-based eCQMs.

Assessing Data Adequacy for High Blood Pressure Clinical Decision Support: A Quantitative Analysis.

OBJECTIVE: This study examines guideline-based high blood pressure (HBP) and hypertension recommendations and evaluates the suitability and adequacy of the data and logic required for a Fast Healthcare Interoperable Resources (FHIR)-based, patient-facing clinical decision support (CDS) HBP application. HBP is a major predictor of adverse health events, including stroke, myocardial infarction, and kidney disease. Multiple guidelines recommend interventions to lower blood pressure, but implementation requires patient-centered approaches, including patient-facing CDS tools. METHODS: We defined concept sets needed to measure adherence to 71 recommendations drawn from eight HBP guidelines. We measured data quality for these concepts for two cohorts (HBP screening and HBP diagnosed) from electronic health record (EHR) data, including four use cases (screening, nonpharmacologic interventions, pharmacologic interventions, and adverse events) for CDS. RESULTS: We identified 102,443 people with diagnosed and 58,990 with undiagnosed HBP. We found that 21/35 (60%) of required concept sets were unused or inaccurate, with only 259 (25.3%) of 1,101 codes used. Use cases showed high inclusion (0.9-11.2%), low exclusion (0-0.1%), and missing patient-specific context (up to 65.6%), leading to data in 2/4 use cases being insufficient for accurate alerting. DISCUSSION: Data quality from the EHR required to implement recommendations for HBP is highly inconsistent, reflecting a fragmented health care system and incomplete implementation of standard terminologies and workflows. Although imperfect, data were deemed adequate for two test use cases. CONCLUSION: Current data quality allows for further development of patient-facing FHIR HBP tools, but extensive validation and testing is required to assure precision and avoid unintended consequences.

Building and maintaining trust in clinical decision support: Recommendations from the Patient-Centered CDS Learning Network.

Knowledge artifacts in digital repositories for clinical decision support (CDS) can promote the use of CDS in clinical practice. However, stakeholders will benefit from knowing which they can trust before adopting artifacts from knowledge repositories. We discuss our investigation into trust for knowledge artifacts and repositories by the Patient-Centered CDS Learning Network's Trust Framework Working Group (TFWG). The TFWG identified 12 actors (eg, vendors, clinicians, and policy makers) within a CDS ecosystem who each may play a meaningful role in prioritizing, authoring, implementing, or evaluating CDS and developed 33 recommendations distributed across nine "trust attributes." The trust attributes and recommendations represent a range of considerations such as the "Competency" of knowledge artifact engineers and the "Organizational Capacity" of institutions that develop and implement CDS. The TFWG findings highlight an initial effort to make trust explicit and embedded within CDS knowledge artifacts and repositories and thus more broadly accepted and used.

Challenges to electronic clinical quality measurement using third-party platforms in primary care practices: the healthy hearts in the heartland experience.

Third-party platforms have emerged to support small primary care practices for calculating and reporting electronic clinical quality measures (eCQM) for federal programs like The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and Merit-based Incentive Payment System (MIPS). Yet little is known about the capabilities and limitations of electronic health record systems (EHRs) to enable data access for these programs. We connected 116 small- to medium-sized practices with seven different EHRs to popHealth, an open-source eCQM platform. We identified the prevalence of following problems with eCQM data for data extraction in seven different EHRs: (1) Lack of coded data in five of seven; (2) Incorrectly categorized data in four of seven; (3) Isosemantic data (data within the incorrect context) in four of seven; (4) Coding that could not be directly evaluated in six of seven; (5) Errors in date assignment and labeled as historical values in five of seven; and (6) Inadequate data to assign the correct code in two of seven. We recommend specific enhancements to EHR systems that can promote effective eCQM implementation and reporting to MACRA and MIPS.

The Imperative for Patient-Centered Clinical Decision Support.

This commentary introduces the Patient-Centered Clinical Decision Support (PCCDS) Learning Network, which is collaborating with AcademyHealth to publish "Better Decisions Together" as part of eGEMs. Patient-centered clinical decision support (CDS) is an important vehicle to address broad issues in the U.S. health care system regarding quality and safety while also achieving better outcomes and better patient and provider satisfaction. Defined as CDS that supports individual patients and their care givers and/or care teams in health-related decisions and actions, PCCDS is an important step forward in advancing endeavors to move patient-centered care forward. The PCCDS Learning Network has developed a framework, referred to as the Analytic Framework for Action (AFA), to organize thinking and activities around PCCDS. A wide array of activities the PCCDS Learning Network is engaging in to inform and connect stakeholders is discussed.

The Potential Role for Smartphones Among Older Adults with Chronic Noncancer Pain: A Qualitative Study.

Objective: To determine the role that smartphones may play in supporting older adults with chronic noncancer pain (CNCP) in order to improve pain management in this expanding population. Design: Qualitative study. Setting: One academically affiliated primary care practice serving older adults with CNCP in New York City. Subjects: Thirteen older adults (age 65-85 years) with CNCP on chronic opioid therapy, that is, continuous use of opioids for at least six months. Methods: One researcher conducted one-on-one telephone interviews with participants, and two researchers analyzed the transcribed data using descriptive analysis. A nurse and a physician researcher iteratively critiqued and approved the results. Results: Participants provided opinions as to the effects that smartphones may have on medication management and communications with their providers. Smartphones can benefit older adults by supporting interactions with the health care system such as more effective scheduling and coordinating prescribing practices with local pharmacies. Participants expressed difficulties with isolation due to CNCP and posited that smartphones could provide a means for social support. Specifically, smartphones should support older adult needs to effectively communicate pain experiences with personal contacts and caregivers, as well as health care providers. Based on these results, we provide suggestions that can inform future smartphone interventions for older adults with CNCP. Conclusion: Smartphones that focus on supporting medication management, enhancing communication with providers, and facilitating connectedness within social networks to reduce feelings of isolation may help to improve CNCP outcomes in older adults.

Placing wireless tablets in clinical settings for patient education.

OBJECTIVE: The authors explored the feasibility and possible benefit of tablet-based educational materials for patients in clinic waiting areas. METHODS: We distributed eight tablets preloaded with diagnosis-relevant information in two clinic waiting areas. Patients were surveyed about satisfaction, usability, and effects on learning. Technical issues were resolved. RESULTS: Thirty-seven of forty patients completed the survey. On average, the patients were satisfied in all categories. CONCLUSIONS: Placing tablet-based educational materials in clinic waiting areas is relatively easy to implement. Patients using tablets reported satisfaction across three domains: usability, education, and satisfaction.

White Matter Diffusion Abnormalities in Carotid Artery Disease: A Systematic Review and Meta-Analysis.

BACKGROUND & PURPOSE: Abnormalities in apparent diffusion coefficient (ADC), fractional anisotropy (FA), and mean diffusivity (MD) values can be used to assess microstructural damage to white matter tracts and could represent a quantitative marker of chronic ischemia and thereby potentially serve as a stroke risk factor or a measure of existing subclinical ischemic disease burden. We performed a systematic review and 3 separate meta-analyses to evaluate the association between unilateral carotid steno-occlusion and ipsilateral ADC, FA, or MD abnormality. MATERIALS & METHODS: A comprehensive literature search evaluating the association of carotid disease and quantitative white matter diffusion imaging was performed. The included studies examined patients for ADC, FA, and MD values ipsilateral and contralateral to the site of carotid artery disease. Three meta-analyses using standardized mean differences with assessment of study heterogeneity were performed. RESULTS: Of the 2,920 manuscripts screened, 6 met eligibility for meta-analysis. Of the included manuscripts, 2 studied ADC values, 6 studied FA values, and 2 studied MD values. Our 3 meta-analyses showed standardized mean difference for ADC, FA, and MD values between cerebral hemispheres ipsilateral and contralateral to carotid artery disease site as 1.13 (95% CI: .79-1.47, P < .001), -.42 (95% CI: -.62 to -.21, P < .001), and .23 (95% CI: -.32 to -.77, P = .41), respectively. Measures of heterogeneity showed mild heterogeneity in the 3 meta-analyses. CONCLUSION: Carotid artery disease is associated with significant ADC and FA value changes, suggesting that carotid disease is associated with quantifiable white matter microstructural damage.

The Community Preceptor Crisis: Recruiting and Retaining Community-Based Faculty to Teach Medical Students-A Shared Perspective From the Alliance for Clinical Education.

ISSUE: Community-based instruction is invaluable to medical students, as it provides "real-world" opportunities for observing and following patients over time while refining history taking, physical examination, differential diagnosis, and patient management skills. Community-based ambulatory settings can be more conducive to practicing these skills than highly specialized, academically based practice sites. The Association of American Medical Colleges and other national medical education organizations have expressed concern about recruitment and retention of preceptors to provide high-quality educational experiences in community-based practice sites. These concerns stem from constraints imposed by documentation in electronic health records; perceptions that student mentoring is burdensome resulting in decreased clinical productivity; and competition between allopathic, osteopathic, and international medical schools for finite resources for medical student experiences. EVIDENCE: In this Alliance for Clinical Education position statement, we provide a consensus summary of representatives from national medical education organizations in 8 specialties that offer clinical clerkships. We describe the current challenges in providing medical students with adequate community-based instruction and propose potential solutions. IMPLICATIONS: Our recommendations are designed to assist clerkship directors and medical school leaders overcome current challenges and ensure high-quality, community-based clinical learning opportunities for all students. They include suggesting ways to orient community clinic sites for students, explaining how students can add value to the preceptor's practice, focusing on educator skills development, recognizing preceptors who excel in their role as educators, and suggesting forms of compensation.

Physician Satisfaction in Practices That Transformed Into Patient-Centered Medical Homes: A Statewide Study in New York.

Patient-centered medical home (PCMH) transformation can significantly affect physicians' job satisfaction, which in turn can affect the quality of patient care. Between November 2012 and March 2013, the study team surveyed 159 community-based physicians in 159 practice sites that had experienced PCMH practice transformations in New York State. Of the 159 physicians, 121 responded (77% response rate) to the online survey. Nearly two thirds (60%) of physicians reported being somewhat or very satisfied overall with their practice after PCMH transformation. Overall satisfaction was lower than satisfaction with specific domains of practice: patient-centered care (82%), coordination of care (81%), access to care (79%), efficiency (76%), organizational culture (69%), and quality (69%). Although the physicians were moderately satisfied with care quality in their practices after PCMH transformation, their overall satisfaction was notably lower. The findings reveal a need to identify factors beyond quality for measuring physician satisfaction in PCMH transformed practices.

Trends in public perceptions of electronic health records during early years of meaningful use.

OBJECTIVES: The proportion of US doctors using electronic health records (EHRs) has risen sharply in response to the federal Meaningful Use (MU) program, which incentivizes EHR adoption. To track consumer perceptions of EHRs during this period, we conducted a national telephone survey annually for 3 consecutive years, from 2011 to 2013, corresponding with the early years of MU. STUDY DESIGN: Nationwide random digit-dial survey. METHODS: The survey used random digit-dial sampling on a dual frame of landline and cell phone numbers in the continental United States, but was not otherwise stratified by geographic region, race, or other variables. Because our primary goal was to identify relationships between variables and EHR attitudes, we constructed post hoc survey weights to align all 3 samples with each other. Relationships between sociodemographics and EHR questions were assessed with logistic regression models using the survey weights. Cross-year comparisons were conducted with χ2 tests and Cochran-Armitage tests for linear trend. RESULTS: Between 2011 and 2013, the proportion of respondents with a doctor who used an EHR rose from 64% to 71%. In 2011, 64% endorsed the belief that EHRs would improve healthcare quality, dropping to 62% by 2013. Simultaneously, the proportion concerned about the effects of EHRs on privacy dropped from 48% to 41%. Consumers whose doctors used EHRs were generally more likely to believe EHRs would improve healthcare quality and less concerned about privacy risks than those whose doctors did not use EHRs. CONCLUSIONS: Overall, we conclude that during the early years of the MU program, exposure to EHRs increased while confidence in the benefits of EHRs and concerns about privacy risks became less marked. The subset of people exposed to EHRs via their physicians continued to have more positive attitudes toward them than those without that exposure. These attitudinal trends may be linked to increased familiarity with health information technology.

Information and informatics literacies of first-year medical students.

PURPOSE: The study evaluated medical students' familiarity with information literacy and informatics during the health sciences library orientation. METHODS: A survey was fielded at the start of the 2013 school year. RESULTS: Seventy-two of 77 students (94%) completed the survey. Over one-half (57%) expected to use library research materials and services. About half (43%) expected to use library physical space. Students preferred accessing biomedical research on laptops and learning via online-asynchronous modes. CONCLUSIONS: The library identified areas for service development and outreach to medical students and academic departments.