Publications

INTRODUCTION: A four-drug regimen of guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) is underused, in part due to prescriber inertia and low patient adherence. Although fixed-dose combination pills ('polypills') have improved adherence and clinical outcomes for other conditions, there are no polypills available that combine multiple classes of GDMT for HFrEF. Pharmacy-level over-encapsulation, in which several tablets are combined into one capsule, offers an opportunity to create customised HFrEF polypills with the goal of improving delivery of HFrEF therapies.

METHODS AND ANALYSIS: In the COMBO-HF-X pilot crossover randomised clinical trial, we will enrol 30-40 patients with HFrEF in a safety-net public healthcare system in San Francisco, California. Participants will be randomised 1:1 to receive GDMT as individual tablets or as a customised, over-encapsulated HFrEF polypill. After 1 month, participants will cross over to the other formulation (individual tablets or a HFrEF polypill). Participants will attend in-person visits at 0, 4 and 8 weeks. GDMT will be initiated and titrated by study physicians as clinically indicated in accordance with HFrEF treatment guidelines. The primary outcome will be adherence to GDMT by pill count. Key feasibility outcomes will include the successful recruitment of 30-40 participants and completion of study procedures for at least 20 participants. Implementation outcomes will include the cost and time required for HFrEF polypill preparation, which will be performed by a community pharmacy partner. Exploratory clinical outcomes will include change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level and Kansas City Cardiomyopathy Questionnaire. Acceptability will be assessed through a patient exit survey and semistructured exit interviews with patients, their primary care and cardiology providers, and pharmacy staff.

ETHICS AND DISSEMINATION: Study findings will be published in peer-reviewed journals. The protocol of this study was approved by the Institutional Review Board of the University of California, San Francisco. Written informed consent for COMBO-HF-X was obtained from all participants.

TRIAL REGISTRATION NUMBER: NCT06029712.

BACKGROUND: Use of pulmonary vein isolation (PVI) to treat atrial fibrillation continues to increase. Despite great interest in leveraging administrative data for real-world analyses, contemporary procedural codes for identifying PVI have not been evaluated.

METHODS AND RESULTS: In this observational retrospective cohort study, inpatient PVIs were identified among US Medicare fee-for-service beneficiaries using Current Procedural Terminology (CPT) code 93656 in Carrier Line Files. Each patient was matched with their claims from Medicare Provider Analysis and Review to compare CPT with International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS) claims submitted by health care facilities to bill for PVIs. We performed the reverse for commonly matched ICD-10-PCS codes, to identify corresponding CPT-billed procedures. Finally, we reviewed institutional cases for additional comparison of CPT and ICD-10-PCS assignation for PVI. We identified 25 617 inpatient PVIs from January 2017 to December 2021, of which 18 165 (71%) were linked to Medicare Provider Analysis and Review. Of these, 16 672 (92%) were billed as ICD-10-PCS 02583ZZ: "Destruction of Conduction Mechanism, Percutaneous Approach." The reverse process yielded heterogeneous results: among 75 003 procedures billed as ICD-10-PCS 02583ZZ, only 15 691 (21%) matched with CPT 93656 (PVI), as several other unrelated procedures were billed under this ICD-10-PCS code. Institutional case review confirmed the greater specificity of CPT codes.

CONCLUSIONS: The ICD-10-PCS code associated with CPT-billed PVI procedures actually referred to ablation of the atrioventricular junction. Yet this ICD-10-PCS code also matched with a wide range of other procedures distinct from PVI. We conclude that ICD-10-PCS codes alone are not sensitive nor specific for identifying PVI in claims and cannot be reliably used in isolation for health services research on this important procedure.

IMPORTANCE: Private equity acquisitions of health care facilities have rapidly increased over the past decade. However, little is known about the effects of private equity acquisitions of US hospitals on patient care experience.

OBJECTIVE: To evaluate whether the acquisition of hospitals by private equity firms was associated with changes in measures of patient-reported experience compared with matched control hospitals from 2008 through 2019.

DESIGN, SETTINGS, AND PARTICIPANTS: This cohort study identified 73 US hospitals newly acquired by private equity firms and 293 matched control (nonacquired) US hospitals from 2008 through 2019. An event study, difference-in-differences design was used to evaluate changes in patient experiences measures from 3 years before to 3 years after private equity acquisition.

MAIN OUTCOMES AND MEASURES: The primary outcomes were 2 global measures of patient-reported care experience from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, which included patients' overall hospital rating and willingness to recommend the hospital. Secondary outcomes included the 7 other HCAHPS measures encompassing clinical process, communication, and environmental measures.

RESULTS: There were 73 private equity-acquired hospitals and 293 matched control hospitals. The percentage of patients rating hospitals as a 9 or 10, on a scale of 0 to 10, decreased at private equity-acquired hospitals (65.0% before acquisition and 65.2% after acquisition) when compared with control hospitals (66.2% to 69.2%) during the postacquisition period relative to the preacquisition period with a difference-in-differences estimate of -2.4 percentage points (95% CI, -3.9 to -0.9). In addition, the percentage of patients who would definitely recommend the hospital also decreased at private equity-acquired hospitals (66.9% before acquisition and 65.5% after acquisition) compared with control hospitals (68.2% to 69.3%) with a difference-in-difference estimate of -2.1 percentage points (95% CI, -3.6 to -0.7). For both of these global measures of patient experience, the difference between private equity-acquired and control hospitals increased over time and was largest in year 3 after acquisition (-5.2 percentage points [95% CI, -8.8 to -1.5] and -4.4 percentage points [95% CI, -8.0 to -0.70] for each measure, respectively). For secondary measures of patient care experience, there was a decrease in patient-reported responsiveness of hospital staff at private equity-acquired hospitals compared with control hospitals (-1.3 percentage points [95% CI, -2.4 to -0.2]), but no differential change across other measures of clinical process, communication, and environment.

CONCLUSIONS AND RELEVANCE: Patient care experience worsened after private equity acquisition of hospitals. These findings raise concern about the implications of private equity acquisitions on patient care experience at US hospitals.

IMPORTANCE: In the 2020 Bostock v Clayton County decision, the US Supreme Court extended employment nondiscrimination protection to sexual minority adults. The health impacts of this ruling and similar policies related to sexual orientation-based discrimination are not currently known.

OBJECTIVE: To estimate changes in mental health following the Bostock decision among sexual minority adults in states that gained employment nondiscrimination protection (intervention states) compared with those in states with protections already in place (control states).

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used 2018-2022 data from the Behavioral Risk Factor Surveillance System and a difference-in-differences approach to evaluate changes in mental health after the Bostock decision by comparing sexual minority adults (aged ≥18 years and identifying as lesbian, gay, or bisexual) in 12 intervention states with those residing in 9 control states. Models were estimated for all participants and separately for employed participants. Data were analyzed between February and September 2024.

EXPOSURE: Residing in a state that gained employment nondiscrimination protection after the Bostock decision.

MAIN OUTCOMES AND MEASURES: The primary outcome was number of poor mental health days during the past 30 days, and the secondary outcome was severe mental distress (defined as 14 or more past-month poor mental health days).

RESULTS: Of 597 462 participants (306 365 in intervention states [77.7% aged 18-64 years and 22.3% aged ≥65 years; 51.7% female] and 291 097 in control states [77.5% aged 18-64 years and 22.5% aged ≥65 years; 50.6% female]), 5.1% in intervention states and 6.0% in control states self-identified as sexual minority adults. The mean (SE) number of past-month poor mental health days was unchanged after the Bostock decision among sexual minority adults in both intervention (from 8.70 [0.27] to 9.59 [0.24] days; adjusted difference, 0.57 [95% CI, -1.02 to 2.16] days) and control (from 8.53 [0.21] to 10.15 [0.20] days; adjusted difference, 1.17 [95% CI, -0.46 to 2.79] days) states, resulting in no differential change between the 2 groups (difference-in-differences, -0.60 days; 95% CI, -1.25 to 0.06 days). Among the subset of employed sexual minority adults, the mean (SE) number of poor mental health days did not change in intervention states (from 7.99 [0.38] to 8.83 [0.30] days; adjusted difference, 0.87 [95% CI, -0.49 to 2.22] days) but increased in control states (from 7.75 [0.27] to 9.75 [0.26] days; adjusted difference, 1.84 [95% CI, 0.44-3.24] days). These findings corresponded to a significant relative reduction in poor mental health days among employed sexual minority adults in intervention vs control states (difference-in-differences, -0.97 days; 95% CI, -1.74 to -0.21 days). Mean (SE) rates of severe mental distress increased less among employed sexual minority adults in intervention (from 26.35% [1.59%] to 29.92% [1.46%]; adjusted difference, 6.81% [95% CI, 2.20%-11.42%]) vs control (from 26.53% [1.27%] to 34.26% [1.16%]; adjusted difference, 10.30% [95% CI, 5.99%-14.61%) states, also corresponding to a significant relative reduction among employed sexual minority adults (difference-in-differences, -3.49%; 95% CI, -6.71% to -0.27%).

CONCLUSIONS AND RELEVANCE: These findings show significant relative reductions in past-month poor mental health days and severe mental distress among employed sexual minority adults after the implementation of a federal ban on employment discrimination based on sexual orientation. Larger and more consistent mental health benefits observed among sexual minority adults in the workforce underscore the importance of broadening protections to other social domains.