A lifecycle framework illustrates eight stages necessary for realizing the benefits of patient-centered clinical decision support.

The design, development, implementation, use, and evaluation of high-quality, patient-centered clinical decision support (PC CDS) is necessary if we are to achieve the quintuple aim in healthcare. We developed a PC CDS lifecycle framework to promote a common understanding and language for communication among researchers, patients, clinicians, and policymakers. The framework puts the patient, and/or their caregiver at the center and illustrates how they are involved in all the following stages: Computable Clinical Knowledge, Patient-specific Inference, Information Delivery, Clinical Decision, Patient Behaviors, Health Outcomes, Aggregate Data, and patient-centered outcomes research (PCOR) Evidence. Using this idealized framework reminds key stakeholders that developing, deploying, and evaluating PC-CDS is a complex, sociotechnical challenge that requires consideration of all 8 stages. In addition, we need to ensure that patients, their caregivers, and the clinicians caring for them are explicitly involved at each stage to help us achieve the quintuple aim.

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.

Creating implementable clinical practice guidelines: the 2020 Focused Updates to the National Heart, Lung, and Blood Institute's Asthma Management Guidelines.

BACKGROUND: The 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group provides the first new clinical practice recommendations from the National Heart, Lung, and Blood Institute (NHLBI) since the previous 2007 asthma management guidelines. Guideline implementability was a high priority for the expert panel, and many approaches were undertaken to enhance the implementability of this clinical guideline update. Within the report, specific implementation guidance sections provide expanded summaries for each recommendation to quickly assist users. The implementation guidance incorporates findings from NHLBI-sponsored focus groups conducted with people who have asthma, caregivers, and health care providers. The findings were used to identify the types of information and tools that individuals with asthma, their caregivers, and their health care providers would find most helpful; ensure that the new asthma guidelines reflect the voices of individuals with asthma and their caregivers; and identify potential barriers to uptake by individuals with asthma and their caregivers. The expert panel used a GRADE-based approach to develop evidence-to-decision tables that provided a framework for assessing the evidence and consideration of a range of contextual factors that influenced the recommendations such as desirable and undesirable effects, certainty of evidence, values, balance of effects, acceptability, feasibility, and equity. To facilitate uptake in clinical care workflow, selected recommendations were converted into structured, computer-based clinical decision support artifacts, and the new recommendations were integrated into existing treatment tables used in the 2007 asthma management guidelines, with which many users are familiar. A comprehensive approach to improve guidelines dissemination and implementation included scientific publications, patient materials, media activities, stakeholder engagement, and professional education. CONCLUSION: We developed evidence-based clinical practice guideline updates for asthma management focused on six topic areas. The guideline development processes and implementation and dissemination activities undertaken sought to enhance implementability by focusing on intrinsic factors as described by Kastner, Gagliardi, and others to produce usable, adoptable, and adaptable guidelines. Enhanced collaboration during guideline development between authors, informaticists, and implementation scientists may facilitate the development of tools that support the application of recommendations to further improve implementability.

Integrating a Patient Engagement App into an Electronic Health Record-Enabled Workflow Using Interoperability Standards.

BACKGROUND: Patient use of mobile health applications is increasing. To promote patient-centered care, data from these apps must be integrated into clinician workflows within the electronic health record (EHR). Health Level 7 Fast Healthcare Interoperability Resources (FHIR) offers a standards-based application programming interface (API) that may support such integration. OBJECTIVE: We aimed to use interoperability standards to integrate a patient mobile application (coronavirus 2019 [COVID-19] Tracker) with an EHR. The COVID-19 Tracker engages patients by sending introductory and reminder text messages, collecting vital signs and symptom data from COVID-19 patients, and providing actionable guidance if concerning issues are identified. This case report explored the use of FHIR APIs to integrate the app into EHR-enabled clinical workflows. METHODS: The authors used notes from project meetings and from semistructured discussions among the application development team to track the design and implementation processes. Seven points of integration between the application and the EHR were identified, and approaches using FHIR to perform these integrations were delineated. RESULTS: Although this clinical decision support integration project benefited from its standards-based approach, many challenges were encountered. These were due to (1) partial implementation of the FHIR standard in the EHR, particularly, components needed for patient engagement applications; (2) limited experience with the adoption of FHIR standards; and (3) gaps in the current FHIR standard. Alternative approaches, often not based on interoperability standards, were developed to overcome these limitations. CONCLUSION: Despite the challenges encountered due to the early stages of FHIR development and adoption, FHIR standards provide a promising mechanism for overcoming longstanding barriers and facilitating the integration of patient engagement apps with EHRs. To accelerate the integration of apps into clinical workflows, additional components of the FHIR standard must be implemented within the EHR and other clinical systems. Continued expansion of available FHIR resources will help with tighter workflow integration.

Nothing for Me or About Me, Without Me: Codesign of Clinical Decision Support.

BACKGROUND: Partnerships among patients, families, caregivers, and clinicians are critical to helping patients lead their best lives given their specific genetics, conditions, circumstances, and the environments in which they live, work, and play. These partnerships extend to the development of health information technology, including clinical decision support (CDS). Design of these technologies, however, often occurs without a profound understanding of the true needs, wants, and concerns of patients and family members. Patient perspective is important not only for patient-facing applications but for provider-facing applications, especially those intended to support shared decision-making. OBJECTIVES: Our objective is to describe models for effectively engaging patients and caregivers during CDS development and implementation and to inspire CDS developers to partner with patients and caregivers to improve the potential impact of CDS. METHODS: This article serves as a case study of how two patient activists successfully implemented models for engaging patients and caregivers in a federal program designed to increase the uptake of research evidence into clinical practice through CDS. Models included virtual focus groups, social media, agile software development, and attention to privacy and cybersecurity. RESULTS: Impact on the federal program has been substantial and has resulted in improved CDS training materials, new prototype CDS applications, prioritization of new functionality and features, and increased engagement of patient and caregiver communities in ongoing projects. Among these opportunities is a group of developers and patient activists dedicated and committed to exploring strategic and operational opportunities to codesign CDS applications. CONCLUSION: Codesign and implementation of CDS can occur as a partnership among developers, implementers, patients, cybersecurity and privacy activists, and caregivers. Several approaches are viable, and an iterative process is most promising. Additional work is needed to investigate scalability of the approaches explored by this case study and to identify measures of meaningful inclusion of patients/caregivers in CDS projects.

To Share is Human! Advancing Evidence into Practice through a National Repository of Interoperable Clinical Decision Support.

BACKGROUND: Healthcare systems devote substantial resources to the development of clinical decision support (CDS) largely independently. The process of translating evidence-based practice into useful and effective CDS may be more efficient and less duplicative if healthcare systems shared knowledge about the translation, including workflow considerations, key assumptions made during the translation process, and technical details. OBJECTIVE: Describe how a national repository of CDS can serve as a public resource for healthcare systems, academic researchers, and informaticists seeking to share and reuse CDS knowledge resources or "artifacts." METHODS: In 2016, the Agency for Healthcare Research and Quality (AHRQ) launched CDS Connect as a public, web-based platform for authoring and sharing CDS knowledge artifacts. Researchers evaluated early use and impact of the platform by collecting user experiences of AHRQ-sponsored and community-led dissemination efforts and through quantitative/qualitative analysis of site metrics. Efforts are ongoing to quantify efficiencies gained by healthcare systems that leverage shared, interoperable CDS artifacts rather than developing similar CDS de novo and in isolation. RESULTS: Federal agencies, academic institutions, and others have contributed over 50 entries to CDS Connect for sharing and dissemination. Analysis indicates shareable CDS resources reduce team sizes and the number of tasks and time required to design, develop, and deploy CDS. However, the platform needs further optimization to address sociotechnical challenges. Benefits of sharing include inspiring others to undertake similar CDS projects, identifying external collaborators, and improving CDS artifacts as a result of feedback. Organizations are adapting content available through the platform for continued research, innovation, and local implementations. CONCLUSION: CDS Connect has provided a functional platform where CDS developers are actively sharing their work. CDS sharing may lead to improved implementation efficiency through numerous pathways, and further research is ongoing to quantify efficiencies gained.

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.

Enhancing Health IT Functionality for Children: The 2015 Children's EHR Format.

Electronic health record (EHR) use throughout the United States has advanced considerably, but functionality to support the optimal care of children has been slower to develop and deploy. A previous team of experts systematically identified gaps in EHR functionality during collaborative work from 2010 to 2013 that produced the Children's EHR Format (Format), funded under the Children's Health Insurance Program Reauthorization Act of 2009, Public Law 111-3. After that, a team of practitioners, software developers, health policy leaders, and other stakeholders examined the Format's exhaustive list of 547 EHR functional requirements in 26 topic areas and found them to be valuable but in need of further refinement and prioritization. Work began in 2014 to develop a shortened high priority list of requirements and provide guidance to improve their use. Through a modified Delphi process that included key document review, selection criteria, multiple rounds of voting, and small group discussion, a multistakeholder work group identified and refined 47 items on the basis of earlier requirements to form the 2015 Children's EHR Format Priority List and developed 16 recommended uses of the Format. The full report of the Format enhancement activities is publicly available. In this article, we aim to promote awareness of these high priority EHR functional requirements for the care of children, sharpen industry focus on adopting these changes, and align all stakeholders in prioritizing specific health information technology functionalities including those essential for well-child preventive care, medication management, immunization tracking, and growth data for specific pediatric subgroups.

Pediatric health care quality measures: considerations for pharmacotherapy.

Measuring the quality use of medicines can be conceptualized as a mechanism for understanding appropriate use, underuse, overuse, or misuse. For pediatric pharmacotherapy, measuring the quality use of medicines requires awareness of the differences in health care between children and adults and the differences in the quality and quantity of science that supports evidence-based practice in pediatric health care compared with adult health care. Here we use the Pediatric Quality Measures Program that arose from the Children's Health Insurance Program Reauthorization Act in the United States to illustrate the challenges in developing quality measures of pediatric pharmacotherapy. The challenges are primarily twofold: (i) weak evidence base for the specific pharmacotherapy in children and (ii) limited data to calculate the measure. A weak evidence base must often be weighed against the importance of the topic if the quality measure is intended to address a known quality of care or public health problem. Limited data because of insufficient amount or inappropriate type will affect implementation of the measure and its eventual usefulness. Methods to meet these challenges often depend on the priorities of and the tools available to end users. Health information technology is emerging as a tool to improve quality measurement but presents additional challenges.

Evaluating the use of a computerized clinical decision support system for asthma by pediatric pulmonologists.

PURPOSE: To investigate use of a new guideline-based, computerized clinical decision support (CCDS) system for asthma in a pediatric pulmonology clinic of a large academic medical center. METHODS: We conducted a qualitative evaluation including review of electronic data, direct observation, and interviews with all nine pediatric pulmonologists in the clinic. Outcome measures included patterns of computer use in relation to patient care, and themes surrounding the relationship between asthma care and computer use. RESULTS: The pediatric pulmonologists entered enough data to trigger the decision support system in 397/445 (89.2%) of all asthma visits from January 2009 to May 2009. However, interviews and direct observations revealed use of the decision support system was limited to documentation activities after clinic sessions ended. Reasons for delayed use reflected barriers common to general medical care and barriers specific to subspecialty care. Subspecialist-specific barriers included the perceived high complexity of patients, the impact of subject matter expertise on the types of decision support needed, and unique workflow concerns such as the need to create letters to referring physicians. CONCLUSIONS: Pediatric pulmonologists demonstrated low use of a computerized decision support system for asthma care because of a combination of general and subspecialist-specific factors. Subspecialist-specific factors should not be underestimated when designing guideline-based, computerized decision support systems for the subspecialty setting.

Accuracy of a computerized clinical decision-support system for asthma assessment and management.

OBJECTIVE: To evaluate the accuracy of a computerized clinical decision-support system (CDSS) designed to support assessment and management of pediatric asthma in a subspecialty clinic. DESIGN: Cohort study of all asthma visits to pediatric pulmonology from January to December, 2009. MEASUREMENTS: CDSS and physician assessments of asthma severity, control, and treatment step. RESULTS: Both the clinician and the computerized CDSS generated assessments of asthma control in 767/1032 (74.3%) return patients, assessments of asthma severity in 100/167 (59.9%) new patients, and recommendations for treatment step in 66/167 (39.5%) new patients. Clinicians agreed with the CDSS in 543/767 (70.8%) of control assessments, 37/100 (37%) of severity assessments, and 19/66 (29%) of step recommendations. External review classified 72% of control disagreements (21% of all control assessments), 56% of severity disagreements (37% of all severity assessments), and 76% of step disagreements (54% of all step recommendations) as CDSS errors. The remaining disagreements resulted from pulmonologist error or ambiguous guidelines. Many CDSS flaws, such as attributing all 'cough' to asthma, were easily remediable. Pediatric pulmonologists failed to follow guidelines in 8% of return visits and 18% of new visits. LIMITATIONS: The authors relied on chart notes to determine clinical reasoning. Physicians may have changed their assessments after seeing CDSS recommendations. CONCLUSIONS: A computerized CDSS performed relatively accurately compared to clinicians for assessment of asthma control but was inaccurate for treatment. Pediatric pulmonologists failed to follow guideline-based care in a small proportion of patients.