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Comprehensive participatory planning and evaluation (CPPE), a model used in community engagement research, has not been applied to patient engagement in research. We describe our methodology and interim results using CPPE in a project focused on improving research engagement of rural and distant patients and stakeholders. Specifically, we describe our development of a causal map and the subsequent use of the map to guide patient and stakeholder-driven evaluation.

Background The HERO registry was established to support research on the impact of the COVID-19 pandemic on US healthcare workers. Objective Describe the COVID-19 pandemic experiences of and effects on individuals participating in the HERO registry. Design Cross-sectional, self-administered registry enrollment survey conducted from April 10 to July 31, 2020. Setting Participants worked in hospitals (74.4%), outpatient clinics (7.4%), and other settings (18.2%) located throughout the nation. Participants A total of 14,600 healthcare workers. Main Measures COVID-19 exposure, viral and antibody testing, diagnosis of COVID-19, job burnout, and physical and emotional distress. Key Results Mean age was 42.0 years, 76.4% were female, 78.9% were White, 33.2% were nurses, 18.4% were physicians, and 30.3% worked in settings at high risk for COVID-19 exposure (e.g., ICUs, EDs, COVID-19 units). Overall, 43.7% reported a COVID-19 exposure and 91.3% were exposed at work. Just 3.8% in both high- and low-risk settings experienced COVID-19 illness. In regression analyses controlling for demographics, professional role, and work setting, the risk of COVID-19 illness was higher for Black/African-Americans (aOR 2.32, 99% CI 1.45, 3.70, p < 0.01) and Hispanic/Latinos (aOR 2.19, 99% CI 1.55, 3.08, p < 0.01) compared with Whites. Overall, 41% responded that they were experiencing job burnout. Responding about the day before they completed the survey, 53% of participants reported feeling tired a lot of the day, 51% stress, 41% trouble sleeping, 38% worry, 21% sadness, 19% physical pain, and 15% anger. On average, healthcare workers reported experiencing 2.4 of these 7 distress feelings a lot of the day. Conclusions Healthcare workers are at high risk for COVID-19 exposure, but rates of COVID-19 illness were low. The greater risk of COVID-19 infection among race/ethnicity minorities reported in the general population is also seen in healthcare workers. The HERO registry will continue to monitor changes in healthcare worker well-being during the pandemic. Trial Registration ClinicalTrials.gov identifier NCT04342806 Supplementary Information The online version contains supplementary material available at 10.1007/s11606-020-06529-z.

ObjectiveNumerous attempts have been made to create a standardized ‘presenting problem’ or ‘chief complaint’ list to characterize the nature of an Emergency Department visit. Previous attempts have failed to gain widespread adoption as none were freely sharable and contained the right level of specificity, structure, and clinical relevance to gain acceptance by the larger emergency medicine community. Using real-world data, we constructed a presenting problem list that addresses these challenges.Materials and MethodsWe prospectively captured the presenting problems for 180,424 consecutive emergency department patient visits at an urban, academic, Level I trauma center in the Boston metro area. No patients were excluded. We used a consensus process to iteratively derive our system using real-world data. We used the first 70% of consecutive visits to derive our ontology; followed by a 6 month washout period, and the remaining 30% for validation. All concepts were mapped to SNOMED-CT.ResultsOur system consists of a polyhierarchical ontology containing 692 unique concepts, 2,118 synonyms, and 30,613 non-visible descriptions to correct misspellings and non-standard terminology. Our ontology successfully captured structured data for 95.9% of visits in our validation dataset.Discussion and ConclusionWe present the HierArchical Presenting Problem ontologY (HaPPy). This ontology was empirically derived then iteratively validated by an expert consensus panel. HaPPy contains 692 presenting problem concepts, each concept being mapped to SNOMED-CT. This freely sharable ontology can help to facilitate presenting problem based quality metrics, research, and patient care.

Objective Clinical research data warehouses are largely populated from information extracted from electronic health records (EHRs). While these data provide information about a patient’s medications, laboratory results, diagnoses, and history, her social, economic, and environmental determinants of health are also major contributing factors in readmission, morbidity, and mortality and are often absent or unstructured in the EHR. Details about a patient’s socioeconomic status may be found in the U.S. census. To facilitate researching the impacts of socioeconomic status on health outcomes, clinical and socioeconomic data must be linked in a repository in a fashion that supports seamless interrogation of these diverse data elements. This study demonstrates a method for linking clinical and location-based data and querying these data in a de-identified data warehouse using Informatics for Integrating Biology and the Bedside. Materials and Methods Patient data were extracted from the EHR at Nebraska Medicine. Socioeconomic variables originated from the 2011-2015 five-year block group estimates from the American Community Survey. Data querying was performed using Informatics for Integrating Biology and the Bedside. All location-based data were truncated to prevent identification of a location with a population Results We successfully linked location-based and clinical data in a de-identified data warehouse and demonstrated its utility with a sample use case. Discussion With location-based data available for querying, research investigating the impact of socioeconomic context on health outcomes is possible. Efforts to improve geocoding can readily be incorporated into this model. Conclusion This study demonstrates a means for incorporating and querying census data in a de-identified clinical data warehouse.

BACKGROUND: The appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy. METHODS: Using an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardiovascular disease to a strategy of 81 mg or 325 mg of aspirin per day. The primary effectiveness outcome was a composite of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke, assessed in a time-to-event analysis. The primary safety outcome was hospitalization for major bleeding, also assessed in a time-to-event analysis. RESULTS: A total of 15,076 patients were followed for a median of 26.2 months (interquartile range [IQR], 19.0 to 34.9). Before randomization, 13,537 (96.0% of those with available information on previous aspirin use) were already taking aspirin, and 85.3% of these patients were previously taking 81 mg of daily aspirin. Death, hospitalization for myocardial infarction, or hospitalization for stroke occurred in 590 patients (estimated percentage, 7.28%) in the 81-mg group and 569 patients (estimated percentage, 7.51%) in the 325-mg group (hazard ratio, 1.02; 95% confidence interval [CI], 0.91 to 1.14). Hospitalization for major bleeding occurred in 53 patients (estimated percentage, 0.63%) in the 81-mg group and 44 patients (estimated percentage, 0.60%) in the 325-mg group (hazard ratio, 1.18; 95% CI, 0.79 to 1.77). Patients assigned to 325 mg had a higher incidence of dose switching than those assigned to 81 mg (41.6% vs. 7.1%) and fewer median days of exposure to the assigned dose (434 days [IQR, 139 to 737] vs. 650 days [IQR, 415 to 922]). CONCLUSIONS: In this pragmatic trial involving patients with established cardiovascular disease, there was substantial dose switching to 81 mg of daily aspirin and no significant differences in cardiovascular events or major bleeding between patients assigned to 81 mg and those assigned to 325 mg of aspirin daily. (Funded by the Patient-Centered Outcomes Research Institute; ADAPTABLE ClinicalTrials.gov number, NCT02697916.).

Objectives To determine adherence to Choosing Wisely recommendations for using serum lipase to diagnose acute pancreatitis rather than amylase, avoiding concurrent amylase/lipase testing and avoiding serial measurements after the first elevated test as both are ineffective for tracking disease course. Methods Deidentified laboratory data from four large health systems were analyzed to determine concurrent testing rates, serial testing rates, and provider-ordering patterns. Results While most providers adhered to recommendations with 58,693 lipase-only tests ordered and performed, 86% of amylase tests were performed concurrently with lipase. Ambulatory, inpatient, and emergency department settings revealed concurrent rates of 51%, 41%, and 8%, respectively. Services with order sets containing both amylase and lipase were associated with higher rates of concurrent testing. Conclusions Concurrent amylase/lipase testing is an area of opportunity to improve compliance, especially in ambulatory settings. Revision of order sets and provider education could be interventions to reduce unnecessary testing and save costs.

Background: Unreliable compliance with infection prevention procedures necessitates an analysis of contributing factors. Methods: A retrospective study explored utility of 3236 nursing hygiene notes in the electronic healthcare record system (EHR). This 2012–2013 study identified defects in the chlorhexidine (CHG) bathing practice for a hospital unit. Results: The overall compliance with CHG bathing was 22.99%. Patients with length of stay less than 3 days, in most cases, did not have documentation for CHG bathing. Patient refusal to bathe was the most prevalent documented reason (66%) of the unsuccessful initial and repeated offers to bathe. The regular staff were statistically less successful in convincing patients to bathe. The 1455 notes produced by the regular staff (n = 10) demonstrated a significantly higher failure rate (56.08%) to execute this procedure in comparison with 1770 notes documented by the 246 temporary staff (31.19% failure rate) ( P value Discussion: This analysis yielded three main insights: lack of the CHG documentation in a large number of short admissions; inconsistent use of CHG baths; and presence of workarounds due to patient refusals to bathe. The study concluded that EHR structured and unstructured data can unlock the opportunity for identifying hidden defects and inform decision-makers about the need for change.

Importance Bariatric surgery can lead to substantial improvements in type 2 diabetes (T2DM), but outcomes vary across procedures and populations. It is unclear which bariatric procedure has the most benefits for patients with T2DM. Objective To evaluate associations of bariatric surgery with T2DM outcomes. Design, Setting, and Participants This cohort study was conducted in 34 US health system sites in the National Patient-Centered Clinical Research Network Bariatric Study. Adult patients with T2DM who had bariatric surgery between January 1, 2005, and September 30, 2015, were included. Data analysis was conducted from April 2017 to August 2019. Interventions Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). Main Outcome and Measures Type 2 diabetes remission, T2DM relapse, percentage of total weight lost, and change in glycosylated hemoglobin (hemoglobin A1c). Results A total of 9710 patients were included (median [interquartile range] follow-up time, 2.7 [2.9] years; 7051 female patients [72.6%]; mean [SD] age, 49.8 [10.5] years; mean [SD] BMI, 49.0 [8.4]; 6040 white patients [72.2%]). Weight loss was significantly greater with RYGB than SG at 1 year (mean difference, 6.3 [95% CI, 5.8-6.7] percentage points) and 5 years (mean difference, 8.1 [95% CI, 6.6-9.6] percentage points). The T2DM remission rate was approximately 10% higher in patients who had RYGB (hazard ratio, 1.10 [95% CI, 1.04-1.16]) than those who had SG. Estimated adjusted cumulative T2DM remission rates for patients who had RYGB and SG were 59.2% (95% CI, 57.7%-60.7%) and 55.9% (95% CI, 53.9%-57.9%), respectively, at 1 year and 86.1% (95% CI, 84.7%-87.3%) and 83.5% (95% CI, 81.6%-85.1%) at 5 years postsurgery. Among 6141 patients who experienced T2DM remission, the subsequent T2DM relapse rate was lower for those who had RYGB than those who had SG (hazard ratio, 0.75 [95% CI, 0.67-0.84]). Estimated relapse rates for those who had RYGB and SG were 8.4% (95% CI, 7.4%-9.3%) and 11.0% (95% CI, 9.6%-12.4%) at 1 year and 33.1% (95% CI, 29.6%-36.5%) and 41.6% (95% CI, 36.8%-46.1%) at 5 years after surgery. At 5 years, compared with baseline, hemoglobin A1cwas reduced 0.45 (95% CI, 0.27-0.63) percentage points more for patients who had RYGB vs patients who had SG. Conclusions and Relevance In this large multicenter study, patients who had RYGB had greater weight loss, a slightly higher T2DM remission rate, less T2DM relapse, and better long-term glycemic control compared with those who had SG. These findings can help inform patient-centered surgical decision-making.

Electronic Health Records (EHRs) can improve the quality, safety, and efficiency of patient care. Migration to EHRs is progressing, but has been slowed by concerns related to interoperability, security, cost, patient safety, and usability. This paper focuses on EHR usability, specifically heuristic evaluation, or utilizing accepted guidelines for assessing EHR interface design. Health-care researchers initially applied industry-standard heuristics to EHRs, but subsequently health-care-specific groups have adapted and expanded these standard heuristics, calling for development and use of heuristics specific to EHRs. This paper first summarizes the evolution of heuristic evaluation of EHRs, then discusses the similarities and differences between these various approaches. This is an important step in developing community consensus on integrated heuristics, the basis of successful heuristic evaluation of EHRs. We then discuss the ‘Theory of Fit’ as a means of explaining the existence of these somewhat different heuristics, and close with suggestions for further research.

Decisions on antibiotic-resistant infection (ARI) prevention in dynamic health care settings should be agile and target the right process at the right time. Health information technologies can aid the recognition of high-risk situations for ARI transmission and timely facilitate operators' situational awareness (SA) in various military and civilian health care locations or transport platforms. High SA is one of the significant predictors of better performance. The objective of this study was to evaluate the impact of the developed health information visualization (VIZ) on the users' SA regarding situations when risks of ARI transmission and exposure are high. The enrolled 19 subjects assessed the proposed VIZ artifacts representing 1 scenario, compared the VIZ effectiveness against the currently employed local methods, and reported their SA (perception and comprehension) with the use of a pre- and post-self-rating questionnaire. The results showed that the VIZ significantly increased SA in the study subjects and revealed the importance of communicating the risk of exposure to ARIs. The VIZ enabled the participants to quickly acknowledge the high-risk individuals (super-spreaders), locations (hot spots), and biosafety (deficient infection prevention). The study concluded that SA-oriented technologies may be promising for promoting better infection prevention practices.

Background: Although bariatric procedures are commonly performed in clinical practice, long-term data on the comparative effectiveness and safety of different procedures on sustained weight loss, comorbidities, and adverse effects are limited, especially in important patient subgroups (eg, individuals with diabetes, older patients, adolescents, and minority patients). Objective: The objective of this study was to create a population-based cohort of patients who underwent 3 commonly performed bariatric procedures—adjustable gastric band (AGB), Roux-en-Y gastric bypass (RYGB), and sleeve gastrectomy (SG)—to examine the long-term comparative effectiveness and safety of these procedures in both adults and adolescents. Methods: We identified adults (20 to 79 years old) and adolescents (12 to 19 years old) who underwent a primary (first observed) AGB, RYGB, or SG procedure between January 1, 2005 and September 30, 2015 from 42 health systems participating in the Clinical Data Research Networks within the National Patient-Centered Clinical Research Network (PCORnet). We extracted information on patient demographics, encounters with healthcare providers, diagnoses recorded and procedures performed during these encounters, vital signs, and laboratory test results from patients’ electronic health records (EHRs). The outcomes of interest included weight change, incidence of major surgery-related adverse events, and diabetes remission and relapse, collected for up to 10 years after the initial bariatric procedure. Results: A total of 65,093 adults and 777 adolescents met the eligibility criteria of the study. The adult subcohort had a mean age of 45 years and was predominantly female (79.30%, 51,619/65,093). Among adult patients with non-missing race or ethnicity information, 72.08% (41,248/57,227) were White, 21.13% (12,094/57,227) were Black, and 20.58% (13,094/63,637) were Hispanic. The average highest body mass index (BMI) recorded in the year prior to surgery was 49 kg/m2. RYGB was the most common bariatric procedure among adults (49.48%, 32,208/65,093), followed by SG (45.62%, 29,693/65,093) and AGB (4.90%, 3192/65,093). The mean age of the adolescent subcohort was 17 years and 77.5% (602/777) were female. Among adolescent patients with known race or ethnicity information, 67.3% (473/703) were White, 22.6% (159/703) were Black, and 18.0% (124/689) were Hispanic. The average highest recorded BMI in the year preceding surgery was 53 kg/m2. The majority of the adolescent patients received SG (60.4%, 469/777), followed by RYGB (30.8%, 239/777) and AGB (8.9%, 69/777). A BMI measurement (proxy for follow-up) was available in 84.31% (44,978/53,351), 68.09% (20,783/30,521), and 68.56% (7159/10,442) of the eligible adult patients at 1, 3, and 5 years of follow-up, respectively. The corresponding proportion was 82.0% (524/639), 49.9% (174/349), and 38.8% (47/121) in the adolescent subcohort. Conclusions: Our study cohort is one of the largest cohorts of patients with bariatric procedures in the United States. Patients are geographically and demographically diverse, which improves the generalizability of the research findings and allows examination of treatment effect heterogeneity. Ongoing and planned investigations will provide real-world evidence on the long-term benefits and risks of these most commonly used bariatric procedures in current clinical practice.

Summary Objective: The objective of this case report is to evaluate the importance of specialized domain knowledge when designing and using structured templated notes in a clinical environment. Methods: To analyze the impact of specialization on structured note generation we compared notes generated for three scenarios: 1) We compared the templated history of present illness (HPI) for patients presenting with a dermatology concern to the dermatologist versus the emergency department. 2) We compared the evaluation of chest pain by ED physicians versus cardiologists. 3) Finally, we compared the data elements asked for in the evaluation of the gastrointestinal system between cardiologists and the liver transplant service (LTS). We used the SNOMED CT representation via BioPortal to evaluate specificity and grouping between data elements and specialized physician groups. Results: We found few similarities in structured data elements designed by and for the specific physician groups. The distinctness represented both differences in granularity as well as fundamental differences in data elements requested. When compared to ED physicians, dermatologists had different and more granular elements while cardiologists requested much more granular data. Comparing cardiologists and LTS, there were differences in the data elements requested. Conclusion: This case study supports the importance of domain knowledge in EHR design and implementation. That different specialities should want and use different information is well supported by cognitive science literature. Despite this, it is rare for domain knowledge to be considered in EHR implementation. Physicians with correct domain knowledge should be involved in the design process of templated notes.

SummaryObjective: Less than 20% of hospitals in the US have an electronic health record (EHR). In this qualitative study, we examine the perspectives of both academic and private physicians and administrators as stakeholders, and their alignment, to explore their perspectives on the use of technology in the clinical environment.Methods: Focus groups were conducted with 74 participants who were asked a series of open-ended questions. Grounded theory was used to analyze the transcribed data and build convergent themes. The relevance and importance of themes was constructed by examining frequency, convergence, and intensity. A model was proposed that represents the interactions between themes. Results: Six major themes emerged, which include the impact of EHR systems on workflow, patient care, communication, research/outcomes/billing, education/learning, and institutional culture. Academic and private physicians were confident of the future benefits of EHR systems, yet cautious about the current implementations of EHR, and its impact on interactions with other members of the healthcare team and with patients, and the amount of time necessary to use EHR’s. Private physicians differed on education and were uneasy about the steep learning curve necessary for use of new systems. In contrast to physicians, university and hospital administrators are optimistic, and value the availability of data for use in reporting.Conclusion: The results of our study indicate that both private and academic physicians concur on the need for features that maintain and enhance the relationship with the patient and the healthcare team. Resistance to adoption is related to insufficient functionality and its potential negative impact on patient care. Integration of data collection into clinical workflows must consider the unexpected costs of data acquisition.