Reimagining How We Synthesize Information to Impact Clinical Care, Policy, and Research Priorities in Real Time: Examples and Lessons Learned from COVID-19.

Real-time clinical care, policy, and research decisions need real-time evidence synthesis. However, as we found during the COVID-19 pandemic, it is challenging to rapidly address key clinical and policy questions through rigorous, relevant, and usable evidence. Our objective is to present three exemplar cases of rapid evidence synthesis products from the Veterans Healthcare Administration Evidence Synthesis Program (ESP) and, in the context of these examples, outline ESP products, challenges, and lessons learned. We faced challenges in (1) balancing scientific rigor with the speed in which evidence synthesis was needed, (2) sorting through rapidly evolving large bodies of evidence, and (3) assessing the impact of evidence synthesis products on clinical care, policy, and research. We found solutions in (1) engaging stakeholders early, (2) utilizing artificial intelligence capabilities, (3) building infrastructure to establish living reviews, and (4) planning for dissemination to maximize impact.

Anatomic, stage-based repair of secondary mitral valve disease.

OBJECTIVE: Intervention for repair of secondary mitral valve disease is frequently associated with recurrent regurgitation. We sought to determine if there was sufficient evidence to support inclusion of anatomic indices of leaflet dysfunction in the management of secondary mitral valve disease. METHODS: We performed a systematic review and meta-analysis of published reports comparing anatomic indices of leaflet dysfunction with the complexity of valve repair and the outcome from intervention. Patients were stratified by the severity of leaflet dysfunction. A secondary analysis was performed comparing outcomes when procedural complexity was optimally matched to severity of leaflet dysfunction and when intervention was not matched to dysfunction. RESULTS: We identified 6864 publications, of which 65 met inclusion criteria. An association between the severity of leaflet dysfunction and the procedural complexity was highly predictive of satisfactory freedom from recurrent regurgitation. Patients were categorized into 4 groups based on stratification of leaflet dysfunction. Satisfactory results were achieved in 93.7% of patients in whom repair complexity was appropriately matched to severity of leaflet dysfunction and in 68.8% in whom repair was not matched to dysfunction (odds ratio, 0.148; 95% confidence interval, 0.119-0.184; P < .0001). CONCLUSIONS: For patients with secondary mitral valve disease, satisfactory outcome from valve repair improves when procedural complexity is matched to anatomic indices of leaflet dysfunction. Anatomic indices of leaflet dysfunction should be considered when planning interventions for secondary mitral regurgitation. Routine inclusion of anatomic indices in trial design and reporting should facilitate comparison of results and strengthen guidelines. There are sufficient data to support anatomic staging of secondary mitral valve disease.

Characteristics and Disease Burden of Patients With Eosinophilic Granulomatosis With Polyangiitis Initiating Mepolizumab in the United States.

BACKGROUND/OBJECTIVE: Although the high disease burden associated with eosinophilic granulomatosis with polyangiitis (EGPA) has been established, the disease burden in patients initiating mepolizumab in real-world practice is poorly understood. This study aimed to assess characteristics and burden of real-world patients with EGPA initiating mepolizumab. METHODS: This was a database study (GSK study ID: 214156) of US patients (≥12 years old) with EGPA and ≥1 mepolizumab claim (index date) identified from the Merative MarketScan Commercial and Medicare Supplemental Databases (November 1, 2015, to March 31, 2020). Outcomes assessed in the 12-month baseline period before index (inclusive) included patient characteristics, treatment use, EGPA relapses, asthma exacerbations, health care resource utilization, and costs. RESULTS: In the 103 patients included (mean age, 51.1 years; 63.1% female), the most common manifestations were asthma (89.3%), chronic sinusitis (57.3%), and allergic rhinitis (43.7%). In total, 91.3% of patients had ≥1 oral corticosteroid (OCS) claim (median dose, 7.4 mg/d prednisone-equivalent), 45.6% were chronic OCS users (≥10 mg/d during the 90 days preindex), 99.0% had ≥1 EGPA-related relapse, and 62.1% ≥1 asthma exacerbation. During the baseline period, 26.2% and 97.1% of patients had EGPA-related inpatient admissions and office visits, respectively. Median all-cause total health care costs per patient were $33,298, with total outpatient costs ($16,452) representing the largest driver. CONCLUSIONS: Before initiating mepolizumab, a substantial real-world EGPA disease burden is evident for patients, with resulting impact on health care systems, and indicative of unmet medical needs. Mepolizumab treatment, with a demonstrated positive clinical benefit-risk profile may represent a useful treatment option for reducing EGPA disease burden.

Widespread Community Transmission of Hepatitis A Virus Following an Outbreak at a Local Restaurant - Virginia, September 2021-September 2022.

Hepatitis A is a vaccine-preventable liver infection caused by the hepatitis A virus (HAV); it is transmitted through ingestion of food or drink that has been contaminated by small amounts of infected stool, or through direct contact, including sexual contact, with a person who is infected (1). After years of historically low rates of hepatitis A in the United States, the incidence began increasing in 2016, with outbreaks characterized by person-to-person HAV transmission among persons who use drugs, persons experiencing homelessness, and men who have sex with men (2,3). As of September 2022, 13 states were experiencing outbreaks, including Virginia (3). In September 2021, the Roanoke City and Alleghany Health Districts (RCAHD) in southwestern Virginia investigated an outbreak of hepatitis A. The outbreak, which resulted in 51 cases, 31 hospitalizations, and three deaths, was associated with a food handler who was infected. After the outbreak, the community experienced ongoing person-to-person transmission of HAV, predominantly among persons who use injection drugs. As of September 30, 2022,* an additional 98 cases had been reported to RCAHD. The initial outbreak and community transmission have exceeded US$3 million in estimated direct costs (4,5). This report describes the initial outbreak and the ongoing community transmission of HAV. Increasing vaccination coverage among persons with risk factors for hepatitis A infection is important, including among those who use drugs. Strengthening community partnerships between public health officials and organizations that employ persons with risk factors for acquisition of HAV could help to prevent infections and outbreaks.

Dashboard Design to Identify and Balance Competing Risk of Multiple Hospital-Acquired Conditions.

BACKGROUND: Hospital-acquired conditions (HACs) are common, costly, and national patient safety priority. Catheter-associated urinary tract infections (CAUTIs), hospital-acquired pressure injury (HAPI), and falls are common HACs. Clinicians assess each HAC risk independent of other conditions. Prevention strategies often focus on the reduction of a single HAC rather than considering how actions to prevent one condition could have unintended consequences for another HAC. OBJECTIVES: The objective of this study is to design an empirical framework to identify, assess, and quantify the risks of multiple HACs (MHACs) related to competing single-HAC interventions. METHODS: This study was an Institutional Review Board approved, and the proof of concept study evaluated MHAC Competing Risk Dashboard to enhance clinicians' management combining the risks of CAUTI, HAPI, and falls. The empirical model informing this study focused on the removal of an indwelling urinary catheter to reduce CAUTI, which may impact HAPI and falls. A multisite database was developed to understand and quantify competing risks of HACs; a predictive model dashboard was designed and clinical utility of a high-fidelity dashboard was qualitatively tested. Five hospital systems provided data for the predictive model prototype; three served as sites for testing and feedback on the dashboard design and usefulness. The participatory study design involved think-aloud methods as the clinician explored the dashboard. Individual interviews provided an understanding of clinician's perspective regarding ease of use and utility. RESULTS: Twenty-five clinicians were interviewed. Clinicians favored a dashboard gauge design composed of green, yellow, and red segments to depict MHAC risk associated with the removal of an indwelling urinary catheter to reduce CAUTI and possible adverse effects on HAPI and falls. CONCLUSION: Participants endorsed the utility of a visual dashboard guiding clinical decisions for MHAC risks preferring common stoplight color understanding. Clinicians did not want mandatory alerts for tool integration into the electronic health record. More research is needed to understand MHAC and tools to guide clinician decisions.

Challenges in Heart Failure Disease Management in Skilled Nursing Facilities: A Qualitative Study.

Clinical guidelines recommend clinicians in skilled nursing facilities (SNFs) monitor body weight and signs and symptoms related to heart failure (HF) and encourage a sodium restricted diet to improve HF outcomes; however, SNFs face considerable challenges in HF disease management (HF-DM). In the current study, we characterized the challenges of HF-DM with data from semi-structured, in-depth interviews with patients, caregivers, staff, and physicians from nine SNFs. Patients receiving skilled nursing care were interviewed together as a dyad with their caregiver. A data-driven, qualitative descriptive approach was used to understand the process and challenges of HF-DM. Coded text was categorized into descriptive themes. Interviews with five dyads (n = 10 individuals), SNF nurses and certified nursing assistants (n = 13), and physicians (n = 2) revealed that, among the sample, HF care was not prioritized above other competing health concerns. Staff operated in the challenging SNF environment largely without protocols or educational materials to prompt HF-DM. [Journal of Gerontological Nursing, 48(5), 13-17.].

Psychological interventions with older adults during inpatient postacute rehabilitation: A systematic review.

Objective: Older adults in inpatient postacute care settings report high rates of depression and anxiety. Psychological interventions address these symptoms through educational, cognitive, behavioral, relaxation, and/or psychosocial approaches. The purpose of this study was to systematically evaluate the quality of existing literature on psychological interventions for depression and/or anxiety among older adults during an inpatient postacute care stay. Method: Medline, Embase, Cochrane Library, CINAHL, PsycINFO, and Google Scholar were searched for key concepts. Studies were included that (a) sampled skilled nursing facility or inpatient rehabilitation facility patients, (b) evaluated a psychological intervention, (c) measured depression and/or anxiety symptoms before and after interventions, and (d) had a mean or median age of 65+. Two raters assessed articles for inclusion and risk of bias. Results: Search strategies identified 7,506 articles for screening; nine met inclusion criteria. Included studies varied by study design, intervention type, and methodological quality. Only one study had low overall risk of bias. Four studies demonstrated preliminary treatment benefits for depression symptoms; none reported benefits for anxiety symptoms. Conclusions: Most of the included studies were limited by small sample size and high risk of bias. Thus, currently, there is insufficient evidence to support the effectiveness of psychological interventions for depression or anxiety among older adults during an inpatient postacute care stay. The authors offer a detailed discussion of methodological limitations, empirical gaps, and future directions to develop this body of literature. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Economic burden of growth hormone deficiency in a US pediatric population.

BACKGROUND: Pediatric growth hormone deficiency (GHD) is a rare disorder of short stature that is currently treated with daily injections of somatropin. In addition to short stature, GHD is associated with other comorbidities such as impaired musculoskeletal development, cardiovascular disease, and decreased quality of life. OBJECTIVE: To analyze somatropin utilization, adherence, and health care costs among children with GHD who had either Medicaid or commercial health insurance. METHODS: Children (aged < 18 years) with a GHD diagnosis between January 1, 2008, and December 31, 2017, were identified in the IBM MarketScan Commercial and Medicaid databases. Patients with at least 12- and 6-month continuous enrollment pre- and postdiagnosis were eligible. Children with GHD were direct matched (1:3) to controls without GHD (or other short stature-related disorders) on age, gender, plan type, region, and race (Medicaid only). Index date was the date of the first GHD diagnosis during the selection window for GHD patients and using random assignment for controls. Patients were followed until the end of continuous database enrollment or December 31, 2018. Baseline comorbidities and medications were measured during the 12 months pre-index, whereas somatropin treatment patterns along with all-cause and GHD-related health care costs were measured during the variable follow-up period. Multivariable modeling was used to compare costs between GHD patients and controls and between somatropin-treated and -untreated GHD patients while adjusting for baseline characteristics. RESULTS: There were 6,820 Medicaid and 14,070 commercial patients with GHD who met the study inclusion criteria. Mean (SD) age at index was 9.5 (4.5) years for Medicaid patients and 11.1 (3.7) years for commercial patients. The majority of patients were male (> 65%), and mean follow-up time for all cases and controls was 3-4 years. Overall, 63.2% of Medicaid and 68.4% of commercial GHD patients were treated with somatropin at some point during follow-up. Among Medicaid GHD patients, the treatment rate was highest among White males and lowest among Black females. Adherence was low as the proportion of days covered was ≥ 80% for only 18.4% of Medicaid patients and 32.3% of commercial patients and 49.1% of treated Medicaid and 24.3% of treated commercial patients discontinued before turning age 13. After adjusting for baseline characteristics, all-cause non-somatropin annualized costs were 5.67 times higher (Δ$19,309) for Medicaid GHD patients and 5.46 times higher (Δ$12,305) for commercial GHD patients than matched non-GHD controls. Adjusted all-cause non-somatropin annualized costs were 0.59 times lower (Δ$14,416) for treated Medicaid patients and 0.69 times lower (Δ$7,650) for treated commercial patients than for untreated patients. CONCLUSIONS: Pediatric GHD presents a significant health care burden, and many patients remain untreated or undertreated. Untreated GHD was associated with higher non-somatropin health care costs than treated GHD. Strategies to optimize treatment and improve adherence may reduce the health care burden faced by these patients. DISCLOSURES: This study was funded by Ascendis Pharma, Inc. Smith and Pitukcheewanont are employed by Ascendis Pharma, Inc. Manjelievskaia, Lopez-Gonzalez, and Morrow are employed by IBM Watson Health, which received funding from Ascendis Pharma, Inc., to conduct this study. Kaplowitz is a paid consultant of Ascendis Pharma, Inc.

Patient Characteristics Are Not Associated With Documentation of Weight and Heart Failure Related Sign and Symptom Assessment in Skilled Nursing Facilities.

OBJECTIVE: Monitoring body weight and signs and symptoms related to heart failure (HF) can alert clinicians to a patient's worsening condition but the degree to which these practices are performed in skilled nursing facilities (SNFs) is unknown. This study analyzed the frequency of these monitoring practices in SNFs and explored associated factors at both the patient and SNF level. DESIGN: An observational study of data from the usual care arm of the SNF Connect Trial, a randomized cluster trial of a HF disease management intervention. The data extracted from charts were combined with publicly available facility data. A linear regression model was estimated to evaluate the frequency of HF disease management conditional on patient and facility covariates. SETTING: Data from 28 SNFs in Colorado. PARTICIPANTS: Patients discharged from hospital to SNFs with a primary or secondary diagnosis of HF. MEASUREMENTS: Patient-level covariates included demographics, New York Heart Association class, type of HF, and Charlson comorbidity index. Facility-level covariates were from Nursing Home Compare. RESULTS: The sample (n = 320) was majority female (66%), white (93%), with mean age 80 ± 10 years and a Charlson comorbidity index of 3.2 ± 1.5. Seventy percent had HF with preserved ejection fraction, mean ejection fraction of 50 ± 16% and 40% with a New York Heart Association class III-IV. On average, patients were weighed 40% of their days in the SNF and had documentation of at least 1 HF-related sign or symptom 70% of their days in the SNF. Patient-level factors were not associated with frequency of documenting weight and assessments of HF-related signs/symptoms. Health Inspection Star Rating was positively associated with weight monitoring (P < .05) but not associated with symptom assessment. CONCLUSIONS AND IMPLICATIONS: Patient-level factors are not meaningfully associated with the documentation of weight tracking or sign/symptom assessment. Monitoring weight was instead associated with the Health Inspection Star Rating.

Design and Evaluation of Low-Fidelity Visual Display Prototypes for Multiple Hospital-Acquired Conditions.

Hospital-acquired conditions such as catheter-associated urinary tract infection, stage 3 or 4 hospital-acquired pressure injury, and falls with injury are common, costly, and largely preventable. This study used participatory design methods to design and evaluate low-fidelity prototypes of clinical dashboards to inform high-fidelity prototype designs to visualize integrated risks based on patient profiles. Five low-fidelity prototypes were developed through literature review and by engaging nurses, nurse managers, and providers as participants (N = 23) from two hospitals in different healthcare systems using focus groups and interviews. Five themes were identified from participatory design sessions: Need for Integrated Hospital-Acquired Condition Risk Tool, Information Needs, Sources of Information, Trustworthiness of Information, and Performance Tracking Perspectives. Participants preferred visual displays that represented patient comparative risks for hospital-acquired conditions using the familiar design metaphor of a gauge and green, yellow, and red "traffic light" colors scheme. Findings from this study were used to design a high-fidelity prototype to be tested in the next phase of the project. Visual displays of hospital-acquired conditions that are familiar in display and simplify complex information such as the green, yellow, and red dashboard are needed to assist clinicians in fast-paced clinical environments and be designed to prevent alert fatigue.

Information Needs of Skilled Nursing Facility Staff to Support Heart Failure Disease Management.

OBJECTIVES: Characterize key tasks and information needs for heart failure disease management (HF-DM) in the distinct care setting of skilled nursing facility (SNF) staff in partnership with community-based clinical stakeholders. Develop design recommendations contextualized to the SNF setting for informatics interventions for improved HF-DM in the SNF setting. METHODS: Semi-structured interviews with fifteen participants (registered nurses, licensed practical nurses, certified nursing aides and physicians) from 8 Denver-metro SNFs. Data coded using a data-driven, inductive approach. RESULTS: Key tasks of HF-DM: symptom assessment, communicating change in condition, using equipment, documentation of daily weights, and monitoring patients. Themes: 1) HF-DM is challenged by a culture of verbal communication; 2) staff face knowledge barriers in HF-DM that are partially attributed to unmet information needs. HF-DM information needs: identification of HF patients, HF signs and symptoms, purpose of daily weights, indicators of worsening HF, purpose of sodium restricted diet, and materials to improve patients' understanding of HF. DISCUSSION AND CONCLUSIONS: HF-DM information needs are not fully supported by current SNF information systems.

A local health department's journey to the summit: a case study of a decade of quality improvement.

As the interest in quality improvement (QI) efforts in public health agencies gathers momentum, organizations looking to initiate or strengthen QI processes may benefit from learning about existing programs. This article serves as a case study for other agencies to consider as they embark upon their QI journey. Specifically, this article reviews more than a decade of QI efforts in a mid-sized local health department and highlights areas of success (including an annual QI summit), barriers to implementation of QI, and areas needing improvement.

Diabetes prevention and control in the workplace: a pilot project for county employees.

OBJECTIVES: To improve nutrition and physical activity of county employees and promote weight loss. DESIGN: Random assignment to begin the program when first offered or after 3 months ("wait control" group). SETTING: Worksite. PARTICIPANTS: Onondaga County employees (n = 45) at risk for diabetes (n = 35) or with diabetes (n = 10). Mean (±SD) age = 51.2 (± 8.0) years and body mass index (BMI) = 37.3 ± (6.8 kg/m). INTERVENTION: Twelve weekly healthy lifestyle sessions based on the Diabetes Prevention Program curriculum, followed by monthly sessions for up to 12 months. OUTCOMES: Medical: Weight, BMI, waist circumference, blood pressure, fasting glucose, lipid, and hemoglobin A1c levels. Psychosocial/behavioral: Health-related quality of life Short Form-12, Impact of Weight on Quality of Life Scale), physical activity (International Physical Activity Questionnaire), eating behavior (3-Factor Eating Questionnaire, National Cancer Institute Fat Screener), job satisfaction. RESULTS: The intervention group lost significant weight compared to the wait control group over the first 3 months (mean [95% CI], -2.23 kg [-3.5 to 0.97]) vs [+ 0.73 kg (+0.17 to +1.28)], with a decrease in BMI (P < .001) and waist circumference (P = .004), an increase in physical activity (International Physical Activity Questionnaire, P = .011) and lower dietary fat intake (P = .018). Over 12 months, 22.5% (9/40) lost more than 5% body weight and 12.5% (5/40) lost more than 7% body weight. After the first 3 months, there was gradual partial weight regain but reduction in waist circumference was maintained. The intervention group demonstrated significant improvement in Impact of Weight on Quality of Life Scale (P < .001), 3-Factor Eating (cognitive restraint P < .001, uncontrolled eating P = .003, and emotional eating P = .001), International Physical Activity Questionnaire (P = .011), and Short Form-12 Physical Component Summary (P = .048). No improvements were observed in blood pressure, lipid, hemoglobin A1c, or glucose levels. Job satisfaction was inversely related to BMI at baseline (P = .001) with a trend for improvement with the modest weight loss. CONCLUSIONS: A worksite intervention program can help government employees adopt healthier lifestyles and achieve modest weight loss.

The effect of media attention on concern for and medical management of methicillin-resistant Staphylococcus aureus: a multimethod study.

BACKGROUND: Reports of an increase in the incidence and severity of methicillin-resistant Staphylococcus aureus (MRSA) infections provoked widespread media attention in October 2007. This study attempted to determine whether this widespread media attention led to changes in physician practices related to skin infections. DESIGN: Data collection via LexisNexis, Central New York (CNY) microbiologic laboratory records, publicly available data on Internet search activity, and a survey of CNY healthcare providers allowed for examination of concurrent trends in media attention, public information-seeking behavior, and physician response. RESULTS: During the period of October 15-29, 2007, a roughly 10-fold increase in the number of newspaper and television news broadcasts mentioning "MRSA" and "staph" coincided with a six-to eightfold increase in Internet search activity for the terms "MRSA" and "staph" and a 79 percent increase in provider-reported patient concern with MRSA. In addition, providers reported more frequent orders for cultures and prescription of antibiotics since then. Practices serving urban or low socioeconomic status patients tended to see less MRSA-related concern and activity, indicating a potential disparity in penetration of MRSA information into different populations. CONCLUSIONS: Increased media coverage of MRSA coincided with increased public information-seeking behavior. Self-reported survey data demonstrate that this period was associated with a change in healthcare provider practice, and a concomitant twofold increase in the number of outpatient skin and soft tissue cultures reinforces this link. However, increased public attention appears not to have penetrated urban, less-affluent areas, raising questions about how quickly healthcare information penetrates different patient populations.