Predictors of Death, Survival, Need for Intubation, and Need for Oxygen Support Among Admitted COVID-19 Patients of the Veterans Affairs Greater Los Angeles Healthcare System.

INTRODUCTION: While risk factors for severe COVID-19 infections have been well explored among the public, population-specific studies for the U.S. Veteran community are limited in the literature. By performing a comprehensive analysis of the demographics, comorbidities, and symptomatology of a population of COVID-19 positive Veterans Affairs (VA) patients, we aim to uncover predictors of death, survival, need for intubation, and need for nasal cannula oxygen support among this understudied community. MATERIALS AND METHODS: A retrospective review was conducted of 124 COVID-19 Veteran patients who were admitted from March to October 2020 to the VA Greater Los Angeles Healthcare System (IRB#2020-000272). Chi-square and Fisher's exact tests were employed to assess differences in baseline demographic and clinical variables between Veterans who survived COVID-19 versus those who succumbed to COVID-19 illness. Multivariate logistic regression and Cox regression analyses were employed to assess predictors of outcome variables, including death, survival, need for intubation, and need for oxygen support (via nasal cannula). Covariates included a wide range of demographic, comorbidity-related, symptom-related, and summary index variables. RESULTS: Our study population consisted of primarily senior (average age was 73) Caucasian and African American (52.5% and 40.7%, respectively) Veterans. Bivariate analyses indicated that need for intubation was significantly associated with mortality (P = 0.002). Multivariate analyses revealed that age (P < 0.001, adjusted odds ratio (OR) = 1.16), dyspnea (P = 0.015, OR = 7.73), anorexia (P = 0.022, OR = 16.55), initial disease severity as classified by WHO (P = 0.031, OR = 4.55), and having more than one of the three most common comorbidities (hypertension, diabetes, and cardiac disease) and symptoms (cough, fever, and dyspnea) among our sample (P = 0.009; OR = 19.07) were independent predictors of death. Furthermore, age (P < 0.001, hazard ratio (HR) = 1.14), cerebrovascular disease (P = 0.022, HR = 3.76), dyspnea (P < 0.001, HR = 7.71), anorexia (P < 0.001, HR = 16.75), and initial disease severity as classified by WHO (P = 0.025, HR = 3.30) were independent predictors of poor survival. Finally, dyspnea reliably predicted need for intubation (P = 0.019; OR = 29.65). CONCLUSIONS: Several independent predictors of death, survival, and need for intubation were identified. These risk factors may provide guidelines for risk-stratifying Veterans upon admission to VA hospitals. Additional investigations of COVID-19 prognosis should be conducted on the larger U.S. Veteran population to confirm our findings and add to the current body of literature.

Effect of Androgen Suppression on Clinical Outcomes in Hospitalized Men With COVID-19: The HITCH Randomized Clinical Trial.

Importance: SARS-CoV-2 entry requires the TMPRSS2 cell surface protease. Antiandrogen therapies reduce expression of TMPRSS2. Objective: To determine if temporary androgen suppression induced by degarelix improves clinical outcomes of inpatients hospitalized with COVID-19. Design, Setting, and Participants: The Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization (HITCH) phase 2, placebo-controlled, double-blind, randomized clinical trial compared efficacy of degarelix plus standard care vs placebo plus standard care on clinical outcomes in men hospitalized with COVID-19 but not requiring invasive mechanical ventilation. Inpatients were enrolled at 14 Department of Veterans Affairs hospitals from July 22, 2020, to April 8, 2021. Data were analyzed from August 9 to October 15, 2021. Interventions: Patients stratified by age, history of hypertension, and disease severity were centrally randomized 2:1 to degarelix, (1-time subcutaneous dose of 240 mg) or a saline placebo. Standard care included but was not limited to supplemental oxygen, antibiotics, vasopressor support, peritoneal dialysis or hemodialysis, intravenous fluids, remdesivir, convalescent plasma, and dexamethasone. Main Outcomes and Measures: The composite primary end point was mortality, ongoing need for hospitalization, or requirement for mechanical ventilation at day 15 after randomization. Secondary end points were time to clinical improvement, inpatient mortality, length of hospitalization, duration of mechanical ventilation, time to achieve a temperature within reference range, maximum severity of COVID-19, and the composite end point at 30 days. Results: The trial was stopped for futility after the planned interim analysis, at which time there were 96 evaluable patients, including 62 patients randomized to the degarelix group and 34 patients in the placebo group, out of 198 initially planned. The median (range) age was 70.5 (48-85) years. Common comorbidities included chronic obstructive pulmonary disorder (15 patients [15.6%]), hypertension (75 patients [78.1%]), cardiovascular disease (27 patients [28.1%]), asthma (12 patients [12.5%]), diabetes (49 patients [51.0%]), and chronic respiratory failure requiring supplemental oxygen at baseline prior to COVID-19 (9 patients [9.4%]). For the primary end point, there was no significant difference between the degarelix and placebo groups (19 patients [30.6%] vs 9 patients [26.5%]; P = .67). Similarly, no differences were observed between degarelix and placebo groups in any secondary end points, including inpatient mortality (11 patients [17.7%] vs 6 patients [17.6%]) or all-cause mortality (11 patients [17.7%] vs 7 patents [20.6%]). There were no differences between degarelix and placebo groups in the overall rates of adverse events (13 patients [21.0%] vs 8 patients [23.5%) and serious adverse events (19 patients [30.6%] vs 13 patients [32.4%]), nor unexpected safety concerns. Conclusions and Relevance: In this randomized clinical trial of androgen suppression vs placebo and usual care for men hospitalized with COVID-19, degarelix did not result in amelioration of COVID-19 severity. Trial Registration: ClinicalTrials.gov Identifier: NCT04397718.

Sequelae of an Evidence-based Approach to Management for Access to Care in the Veterans Health Administration.

BACKGROUND: Access to health care is a critical concept in the design, delivery, and evaluation of high quality care. Meaningful evaluation of access requires research evidence and the integration of perspectives of patients, providers, and administrators. OBJECTIVE: Because of high-profile access challenges, the Department of Veterans Affairs (VA) invested in research and implemented initiatives to address access management. We describe a 2-year evidence-based approach to improving access in primary care. METHODS: The approach included an Evidence Synthesis Program (ESP) report, a 22-site in-person qualitative evaluation of VA initiatives, and in-person and online stakeholder panel meetings facilitated by the RAND corporation. Subsequent work products were disseminated in a targeted strategy to increase impact on policy and practice. RESULTS: The ESP report summarized existing research evidence in primary care management and an evaluation of ongoing initiatives provided organizational data and novel metrics. The stakeholder panel served as a source of insights and information, as well as a knowledge dissemination vector. Work products included the ESP report, a RAND report, peer-reviewed manuscripts, presentations at key conferences, and training materials for VA Group Practice Managers. Resulting policy and practice implications are discussed. CONCLUSIONS: The commissioning of an evidence report was the beginning of a cascade of work including exploration of unanswered questions, novel research and measurement discoveries, and policy changes and innovation. These results demonstrate what can be achieved in a learning health care system that employs evidence and expertise to address complex issues such as access management.

Variable validity of computer extracted problem lists for complications of diabetes mellitus within the VA Greater Los Angeles Health System.

PURPOSE: Electronic health data in the form of International Classification of Disease, Ninth Revision (ICD-9) codes is routinely used for clinical research, yet the accuracy of specific diagnoses is largely unknown. The purpose of this study is to assess the validity of computer extracted problem lists for diabetic retinopathy (DR) and other complications of diabetes mellitus (DM) within the VA Greater Los Angeles Health Administration (VHAGLA). METHODS: The study population consisted of patients at the VHAGLA with an ICD-9 diagnosis of DM between Jan 1st 1999 and March 22nd 2016 with visits to the eye clinic. Fifty patients either with or without an ICD-9 diagnosis of DR were randomly selected. The accuracy of ICD-9 codes for DR, as well as related co-morbidities such as hypertension, hyperlipidemia, coronary artery disease (CAD), and cerebrovascular accident (CVA), were assessed through chart review. RESULTS: A total of 3193 patients met our inclusion criteria. Of the 50 patients with an ICD-9 diagnosis of DR, the positive predictive value (PPV) was 0.7. For 50 patients without a ICD-9 diagnosis of DR, the negative predictive value (NPV) was 0.9. Of the other co-morbid medical conditions, NPV ranged from a low of 63% for obesity to a high of 98% for CVA and CAD. CONCLUSION: Validity of ICD-9 diagnoses of diabetic complications in this VA population varied considerably, with DR demonstrating moderate agreement, obesity being more under-documented, and CVA and CAD being more consistently documented. These discrepancies should be considered when using billing codes for research purposes.

Electronic health record-based interventions for improving appropriate diagnostic imaging: a systematic review and meta-analysis.

BACKGROUND: One driver of increasing health care costs is the use of radiologic imaging procedures. More appropriate use could improve quality and reduce costs. PURPOSE: To review interventions that use the computerized clinical decision-support (CCDS) capabilities of electronic health records to improve appropriate use of diagnostic radiologic test ordering. DATA SOURCES: English-language articles in PubMed from 1995 to September 2014 and searches in Web of Science and PubMed of citations related to key articles. STUDY SELECTION: 23 studies, including 3 randomized trials, 7 time-series studies, and 13 pre-post studies that assessed the effect of CCDS on diagnostic radiologic test ordering in adults. DATA EXTRACTION: 2 independent reviewers extracted data on functionality, study outcomes, and context and assessed the quality of included studies. DATA SYNTHESIS: Thirteen studies provided moderate-level evidence that CCDS improves appropriateness (effect size, -0.49 [95% CI, -0.71 to -0.26]) and reduces use (effect size, -0.13 [CI, -0.23 to -0.04]). Interventions with a "hard stop" that prevents a clinician from overriding the CCDS without outside consultation, as well as interventions in integrated care delivery systems, may be more effective. Harms have rarely been assessed but include decreased ordering of appropriate tests and physician dissatisfaction. LIMITATION: Potential for publication bias, insufficient reporting of harms, and poor description of context and implementation. CONCLUSION: Computerized clinical decision support integrated with the electronic health record can improve appropriate use of diagnostic radiology by a moderate amount and decrease use by a small amount. Before widespread adoption can be recommended, more data are needed on potential harms. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs. (PROSPERO registration number: CRD42014007469).

Electronic patient portals: evidence on health outcomes, satisfaction, efficiency, and attitudes: a systematic review.

BACKGROUND: Patient portals tied to provider electronic health record (EHR) systems are increasingly popular. PURPOSE: To systematically review the literature reporting the effect of patient portals on clinical care. DATA SOURCES: PubMed and Web of Science searches from 1 January 1990 to 24 January 2013. STUDY SELECTION: Hypothesis-testing or quantitative studies of patient portals tethered to a provider EHR that addressed patient outcomes, satisfaction, adherence, efficiency, utilization, attitudes, and patient characteristics, as well as qualitative studies of barriers or facilitators, were included. DATA EXTRACTION: Two reviewers independently extracted data and addressed discrepancies through consensus discussion. DATA SYNTHESIS: From 6508 titles, 14 randomized, controlled trials; 21 observational, hypothesis-testing studies; 5 quantitative, descriptive studies; and 6 qualitative studies were included. Evidence is mixed about the effect of portals on patient outcomes and satisfaction, although they may be more effective when used with case management. The effect of portals on utilization and efficiency is unclear, although patient race and ethnicity, education level or literacy, and degree of comorbid conditions may influence use. LIMITATION: Limited data for most outcomes and an absence of reporting on organizational and provider context and implementation processes. CONCLUSION: Evidence that patient portals improve health outcomes, cost, or utilization is insufficient. Patient attitudes are generally positive, but more widespread use may require efforts to overcome racial, ethnic, and literacy barriers. Portals represent a new technology with benefits that are still unclear. Better understanding requires studies that include details about context, implementation factors, and cost.

Exploring barriers and facilitators to the use of computerized clinical reminders.

OBJECTIVE: Evidence-based practices in preventive care and chronic disease management are inconsistently implemented. Computerized clinical reminders (CRs) can improve compliance with these practices in outpatient settings. However, since clinician adherence to CR recommendations is quite variable and declines over time, we conducted observations to determine barriers and facilitators to the effective use of CRs. DESIGN: We conducted an observational study of nurses and providers interacting with CRs in outpatient primary care clinics for two days in each of four geographically distributed Veterans Administration (VA) medical centers. MEASUREMENTS: Three observers recorded interactions of 35 nurses and 55 physicians and mid-level practitioners with the CRs, which function as part of an electronic medical record. Field notes were typed, coded in a spreadsheet, and then sorted into logical categories. We then integrated findings across observations into meaningful patterns and abstracted the data into themes, such as recurrent strategies. Several of these themes translated directly to barriers and facilitators to effective CR use. RESULTS: Optimally using the CR system for its intended purpose was impeded by (1) lack of coordination between nurses and providers; (2) using the reminders while not with the patient, impairing data acquisition and/or implementation of recommended actions; (3) workload; (4) lack of CR flexibility; and (5) poor interface usability. Facilitators included (1) limiting the number of reminders at a site; (2) strategic location of the computer workstations; (3) integration of reminders into workflow; and (4) the ability to document system problems and receive prompt administrator feedback. CONCLUSION: We identified barriers that might explain some of the variability in the use of CRs. Although these barriers may be difficult to overcome, some strategies may increase user acceptance and therefore the effectiveness of the CRs. These include explicitly assigning responsibility for each CR to nurses or providers, improving visibility of positive results from CRs in the electronic medical record, creating a feedback mechanism about CR use, and limiting the overall number of CRs.

Severe hepatotoxicity associated with the dietary supplement LipoKinetix.

BACKGROUND: LipoKinetix (Syntrax, Cape Girardeau, Missouri) is a dietary supplement marketed for weight loss. OBJECTIVE: To describe a possible causal association between LipoKinetix and hepatotoxicity. DESIGN: Case series. SETTING: Outpatient clinic, tertiary care hospital, and U.S. Food and Drug Administration databases. INTERVENTION: Routine medical and supportive care. MEASUREMENTS: Clinical and laboratory evaluation. RESULTS: All patients developed acute hepatotoxicity within 3 months of starting LipoKinetix. At presentation, symptoms and results of laboratory tests were characteristic of acute hepatitis. All patients recovered spontaneously after LipoKinetix use was discontinued. Three of the seven patients, including one who developed fulminant hepatic failure complicated by cerebral edema, were taking LipoKinetix alone at the time of presentation. Of the four patients who were taking multiple supplements, two resumed taking supplements other than LipoKinetix without incident. CONCLUSIONS: The use of LipoKinetix may be associated with hepatotoxicity. Despite extensive evaluations, no other cause for hepatotoxicity could be identified in the seven patients studied.