Development and Validation of a Novel Literature-Based Method to Identify Disparity-Sensitive Surgical Quality Metrics.

BACKGROUND: Disparity in surgical care impedes the delivery of uniformly high-quality care. Metrics that quantify disparity in care can help identify areas for needed intervention. A literature-based Disparity-Sensitive Score (DSS) system for surgical care was adapted by the Metrics for Equitable Access and Care in Surgery (MEASUR) group. The alignment between the MEASUR DSS and Delphi ratings of an expert advisory panel (EAP) regarding the disparity sensitivity of surgical quality metrics was assessed. STUDY DESIGN: Using DSS criteria MEASUR co-investigators scored 534 surgical metrics which were subsequently rated by the EAP. All scores were converted to a 9-point scale. Agreement between the new measurement technique (ie DSS) and an established subjective technique (ie importance and validity ratings) were assessed using the Bland-Altman method, adjusting for the linear relationship between the paired difference and the paired average. The limit of agreement (LOA) was set at 1.96 SD (95%). RESULTS: The percentage of DSS scores inside the LOA was 96.8% (LOA, 0.02 points) for the importance rating and 94.6% (LOA, 1.5 points) for the validity rating. In comparison, 94.4% of the 2 subjective EAP ratings were inside the LOA (0.7 points). CONCLUSIONS: Applying the MEASUR DSS criteria using available literature allowed for identification of disparity-sensitive surgical metrics. The results suggest that this literature-based method of selecting quality metrics may be comparable to more complex consensus-based Delphi methods. In fields with robust literature, literature-based composite scores may be used to select quality metrics rather than assembling consensus panels.

Development and Preliminary Validation of an Instrument to Measure Symptoms and Impacts in Patients with Proliferative Diabetic Retinopathy.

INTRODUCTION: Following a review of patient-reported outcome (PRO) instruments in the literature, existing PRO instruments may not adequately capture the experience of receiving treatment for proliferative diabetic retinopathy (PDR). Therefore, this study aimed to develop a de novo instrument to comprehensively assess the patient experience of PDR. METHODS: This qualitative, mixed-methods study comprised item generation for the Diabetic Retinopathy-Patient Experience Questionnaire (DR-PEQ), content validation in patients with PDR, and preliminary Rasch measurement theory (RMT) analyses. Adult patients with diabetes mellitus and PDR who received aflibercept and/or panretinal photocoagulation within 6 months of study initiation were eligible for participation. The preliminary DR-PEQ comprised four scales: Daily Activities, Emotional Impact, Social Impact, and Vision Problems. DR-PEQ items were generated using existing knowledge of patient experiences in PDR and conceptual gaps identified from existing PRO instruments. Patients indicated the level of difficulty conducting daily activities and frequency experiencing emotional impacts, social impacts, and vision problems attributed to diabetic retinopathy and its treatment in the past 7 days. Content validity was evaluated in two rounds of in-depth, semi-structured patient interviews. Measurement properties were investigated via RMT analyses. RESULTS: The preliminary DR-PEQ comprised 72 items. Overall, mean (SD) patient age was 53.7 (14.7) years. Forty patients completed the first interview; of these, 30 completed the second interview. Patients reported that the DR-PEQ was easily understood and relevant to their experience. Minor revisions, including removal of the Social Impact scale and addition of a Treatment Experience scale, were implemented to generate 85 items spanning four scales: Daily Activities, Emotional Impact, Vision Problems, and Treatment Experience. RMT analyses provided preliminary evidence that the DR-PEQ performed as intended. CONCLUSION: The DR-PEQ evaluated a broad spectrum of symptoms, functional impacts, and treatment experiences relevant to patients with PDR. Additional analyses are warranted to evaluate psychometric properties in a larger patient population.

Variation in Medicaid and commercial payer coverage of aducanumab for Alzheimer's disease.

INTRODUCTION: Ever since the United States Food and Drug Administration (FDA) approved aducanumab and Centers for Medicare & Medicaid Service (CMS) restricted coverage for the drug, a crucial question has been how other payers will behave. This study examined how Medicaid and commercial plans cover aducanumab. METHODS: We created a database of aducanumab coverage policies issued by Medicaid fee-for-service programs (50 states and DC) and 35 of the largest commercial plans (covering ∼ 84% of the commercially insured population). RESULTS: We found that only 41% of Medicaid fee-for-service plans have issued a publicly available coverage policy for aducanumab and that there is wide variation in these coverage criteria. Although the majority of included commercial plans have issued an aducanumab coverage policy, only five plans covered aducanumab for their enrollees. Available coverage polices showed little consistency in how to measure sufficient treatment response. DISCUSSION: Differences in coverage policies mean that Alzheimer's patients' access to aducanumab may vary across jurisdictions and across commercial insurers. HIGHLIGHTS: Less than half of state Medicaid fee-for-service plans issued a publicly available coverage policy for aducanumab. Available Medicaid coverage policies varied substantially in their coverage criteria. The majority of included commercial plans issued an aducanumab coverage policy; only five plans covered aducanumab. Available coverage polices showed little consistency in how to measure sufficient treatment response.

The Patient Experience with Diabetic Retinopathy: Qualitative Analysis of Patients with Proliferative Diabetic Retinopathy.

INTRODUCTION: Few qualitative studies have explored the patient experience of daily life with proliferative diabetic retinopathy (PDR) and associated treatments. Herein, a conceptual model was developed to comprehensively examine symptoms, functional impacts, and treatment experiences in PDR. METHODS: A qualitative, mixed-methods study comprising a literature search and semi-structured interviews with clinicians and patients was conducted. Published literature and online patient resources were searched to identify concepts relevant to patients, including symptoms, functional impacts, and treatment experiences of PDR. Semi-structured interviews with experienced clinicians were conducted to identify symptoms and impacts reported by patients with PDR and to receive feedback regarding concepts identified from the literature search. A preliminary conceptual model was then developed based on findings from the literature search and clinician interviews. Patients with PDR participated in two rounds of semi-structured interviews to identify additional concepts relevant to the patient experience in PDR and associated treatments, which informed revisions to the conceptual model. Saturation of patient interviews was assessed. RESULTS: Findings from the literature search and clinician interviews yielded 109 concepts that were included in a preliminary conceptual model with three overarching domains: symptoms, impacts, and managing the disease. Clinicians confirmed concepts identified from the literature search. During interviews, patients reported a broad spectrum of symptoms (e.g., red vision); functional impacts relating to activities of daily living (e.g., reading), emotional functioning (e.g., loss of independence), and social functioning (e.g., problems recognizing faces); and treatment experiences (e.g., improves eye problems, no change) associated with PDR. Additional concepts elicited in patient interviews informed revisions to the conceptual model. Saturation was achieved in the patient sample. CONCLUSIONS: A wide variety of symptoms, functional impacts, and treatment experiences that significantly affect health-related quality of life were identified in patients with PDR. These insights are critical for understanding PDR symptomology and assessing treatment response.

Disparity-Sensitive Measures in Surgical Care: A Delphi Panel Consensus.

BACKGROUND: In the US, disparities in surgical care impede the delivery of uniformly high-quality care to all patients. There is a lack of disparity-sensitive measures related to surgical care. The American College of Surgeons Metrics for Equitable Access and Care in Surgery group, through research and expert consensus, aimed to identify disparity-sensitive measures in surgical care. STUDY DESIGN: An environmental scan, systematic literature review, and subspecialty society surveys were conducted to identify potential disparity-sensitive surgical measures. A modified Delphi process was conducted where panelists rated measures on both importance and validity. In addition, a novel literature-based disparity-sensitive scoring process was used. RESULTS: We identified 841 potential disparity-sensitive surgical measures. From these, our Delphi and literature-based approaches yielded a consensus list of 125 candidate disparity-sensitive measures. These measures were rated as both valid and important and were supported by the existing literature. CONCLUSION: There are profound disparities in surgical care within the US healthcare system. A multidisciplinary Delphi panel identified 125 potential disparity-sensitive surgical measures that could be used to track health disparities, evaluate the impact of focused interventions, and reduce healthcare inequity.

Hospital In Home: Evaluating Need and Readiness for Implementation (HENRI) in the Department of Veterans Affairs: protocol for a mixed-methods evaluation and participatory implementation planning study.

BACKGROUND AND OBJECTIVES: The Department of Veterans Affairs (VA) Hospital-In-Home (HIH) program delivers patient-centered, acute-level hospital care at home. Compared to inpatient care, HIH has demonstrated improved patient safety, effectiveness, and patient and caregiver satisfaction. The VA Office of Geriatrics & Extended Care (GEC) has supported the development of 12 HIH program sites nationally, yet adoption in VA remains modest, and questions remain regarding optimal implementation practices to extend reach and adaptability of this innovation. Guided by theoretical and procedural implementation science frameworks, this study aims to systematically gather evidence from the 12 HIH programs and to develop a participatory approach to engage stakeholders, assess readiness, and develop/adapt implementation strategies and evaluation metrics. RESEARCH DESIGN AND METHODS: We propose a multi-phase concurrent triangulation design comprising of (1) qualitative interviews with key informants and document review, (2) quantitative evaluation of effectiveness outcomes, and (3) mixed-methods synthesis and adaptation of a Reach Effectiveness Adoption Implementation Maintenance (RE-AIM)-guided conceptual framework. RESULTS: The prospective phase will involve a participatory process of identifying stakeholders (leadership, HIH staff, veterans, and caregivers), engaging in planning meetings informed by implementation mapping, and developing implementation logic models and blueprints. The process will be assessed using a mixed-methods approach through participant observation and document review. DISCUSSION AND IMPLICATION: This study will support the continued spread of HIH programs, generate a catalog of HIH implementation evidence, and create implementation tools and infrastructure for future HIH development. The multi-phase nature of informing prospective planning with retrospective analysis is consistent with the Learning Health System framework.

Does Universal Insurance and Access to Care Influence Disparities in Outcomes for Pediatric Patients with Osteomyelitis?

BACKGROUND: Healthcare disparities are an issue in the surgical management of orthopaedic conditions in children. Although insurance expansion efforts may mitigate racial disparities in surgical outcomes, prior studies have not examined these effects on differences in pediatric orthopaedic care. To assess for racial disparities in pediatric orthopaedic care that may persist despite insurance expansion, we performed a case-control study of the outcomes of children treated for osteomyelitis in the TRICARE system, the healthcare program of the United States Department of Defense and a model of universal insurance and healthcare access. QUESTIONS/PURPOSES: We asked whether (1) the rates of surgical intervention and (2) 90-day outcomes (defined as emergency department visits, readmission, and complications) were different among TRICARE-insured pediatric patients with osteomyelitis when analyzed based on black versus white race and military rank-defined socioeconomic status. METHODS: We analyzed TRICARE claims from 2005 to 2016. We identified 2906 pediatric patients, of whom 62% (1810) were white and 18% (520) were black. A surgical intervention was performed in 9% of the patients (253 of 2906 patients). The primary outcome was receipt of surgical intervention for osteomyelitis. Secondary outcomes included 90-day complications, readmissions, and returns to the emergency department. The primary predictor variables were race and sponsor rank. Military rank has been used as an indicator of socioeconomic status before and during enlistment, and enlisted service members, particularly junior enlisted service members, may be at risk of having the same medical conditions that affect civilian members of lower socioeconomic strata. Patient demographic information (age, sex, race, sponsor rank, beneficiary category [whether the patient is an insurance beneficiary from an active-duty or retired service member], and geographic region) and clinical information (prior comorbidities, environment of care [whether clinical care was provided in a civilian or military facility], treatment setting, and length of stay) were used as covariates in multivariable logistic regression analyses. RESULTS: After controlling for demographic and clinical factors including age, sex, sponsor rank, beneficiary category, geographic region, Charlson comorbidity index (as a measure of baseline health), environment of care, and treatment setting (inpatient versus outpatient), we found that black children were more likely to undergo surgical interventions for osteomyelitis than white children (odds ratio 1.78; 95% confidence interval, 1.26-2.50; p = 0.001). When stratified by environment of care, this finding persisted only in the civilian healthcare setting (OR 1.85; 95% CI, 1.26-2.74; p = 0.002). Additionally, after controlling for demographic and clinical factors, lower socioeconomic status (junior enlisted personnel) was associated with a higher likelihood of 90-day emergency department use overall (OR 1.60; 95% CI, 1.02-2.51; p = 0.040). CONCLUSIONS: We found that for pediatric patients with osteomyelitis in the universally insured TRICARE system, many of the historically reported disparities in care were absent, suggesting these patients benefitted from improved access to healthcare. However, despite universal coverage, racial disparities persisted in the civilian care environment, suggesting that no single intervention such as universal insurance sufficiently addresses differences in racial disparities in care. Future studies can address the pervasiveness of these disparities in other patient populations and the various mechanisms through which they exert their effects, as well as potential interventions to mitigate these disparities. LEVEL OF EVIDENCE: Level III, prognostic study.

Assessment of Patient-Centered Approaches to Collect Sexual Orientation and Gender Identity Information in the Emergency Department: The EQUALITY Study.

Importance: Health care and government organizations call for routine collection of sexual orientation and gender identity (SOGI) information in the clinical setting, yet patient preferences for collection methods remain unknown. Objective: To assess of the optimal patient-centered approach for SOGI collection in the emergency department (ED) setting. Design, Setting, and Participants: This matched cohort study (Emergency Department Query for Patient-Centered Approaches to Sexual Orientation and Gender Identity [EQUALITY] Study) of 4 EDs on the east coast of the United States sequentially tested 2 different SOGI collection approaches between February 2016 and March 2017. Multivariable ordered logistic regression was used to assess whether either SOGI collection method was associated with higher patient satisfaction with their ED experience. Eligible adults older than 18 years who identified as a sexual or gender minority (SGM) were enrolled and then matched 1 to 1 by age (aged ≥5 years) and illness severity (Emergency Severity Index score ±1) to patients who identified as heterosexual and cisgender (non-SGM), and to patients whose SOGI information was missing (blank field). Patients who identified as SGM, non-SGM, or had a blank field were invited to complete surveys about their ED visit. Data analysis was conducted from April 2017 to November 2017. Interventions: Two SOGI collection approaches were tested: nurse verbal collection during the clinical encounter vs nonverbal collection during patient registration. The ED physicians, physician assistants, nurses, and registrars received education and training on sexual or gender minority health disparities and terminology prior to and throughout the intervention period. Main Outcomes and Measures: A detailed survey, developed with input of a stakeholder advisory board, which included a modified Communication Climate Assessment Toolkit score and additional patient satisfaction measures. Results: A total of 540 enrolled patients were analyzed; the mean age was 36.4 years and 66.5% of those who identified their gender were female. Sexual or gender minority patients had significantly better Communication Climate Assessment Toolkit scores with nonverbal registrar form collection compared with nurse verbal collection (mean [SD], 95.6 [11.9] vs 89.5 [20.5]; P = .03). No significant differences between the 2 approaches were found among non-SGM patients (mean [SD], 91.8 [18.9] vs 93.2 [13.6]; P = .59) or those with a blank field (92.7 [15.9] vs 93.6 [14.7]; P = .70). After adjusting for age, race, illness severity, and site, SGM patients had 2.57 (95% CI, 1.13-5.82) increased odds of a better Communication Climate Assessment Toolkit score category during form collection compared with verbal collection. Conclusions and Relevance: Sexual or gender minority patients reported greater comfort and improved communication when SOGI was collected via nonverbal self-report. Registrar form collection was the optimal patient-centered method for collecting SOGI information in the ED.