Shah, Nilay D.

The optimal patient panel size (PPS) in primary care and the factors determining it remain unclear. We conducted a meta-narrative review of the literature to evaluate factors influencing PPS and assess its association with patient outcomes. A comprehensive search of electronic databases was performed from inception through December 2023, focusing on original studies reporting factors used to determine PPS and related outcomes (eg, clinical outcomes, process measures, and resource utilization). A total of 48 studies were included, identifying 7 key factors influencing PPS. Smaller panels were associated with improved patient satisfaction, continuity of care, and health promotion, while clinical outcomes, utilization, and costs showed minimal impact by PPS. Panel size was primarily associated with patient age, sex, comorbidities, and practice type and structure. Community-based centers typically managed smaller panels, often staffed by female clinicians and serving socioeconomically disadvantaged populations with greater health needs than hospital-based practices. Female clinicians were also independently associated with managing smaller panels, higher quality care indicators, fewer emergency department visits, and improved patient satisfaction. Determining the ideal PPS is a multifaceted process influenced by practice setting, patient demographics, and clinician characteristics. While practice-related factors showed limited association with PPS, patient-reported outcomes were more closely linked to it. Primary care practices should tailor panel sizes to their patient populations, emphasizing a patient-centered approach and ensuring adequate infrastructure support to optimize care delivery.

Objectives To evaluate the feasibility for use of electronic health record (EHR) data in conducting adverse event surveillance among women who received mid-urethral slings (MUS) to treat stress urinary incontinence (SUI) in five health systems. Design Retrospective observational study using EHR data from 2010 through 2021. Women with a history of MUS were identified using common data models; a common analytic code was executed at each site. A manual chart review was conducted in a per-site random patient subset to establish a reference standard. Automated text processing (Text Processed Integrated (TPI)) was developed and evaluated at each site to determine the surgical approach and synthetic mesh implantation. Patients were characterized and surgical outcomes were ascertained over 730 subsequent days. Setting Five large tertiary care academic medical centers. Participants Across five health systems, 9,906 eligible patients (mean age 57–60 per site) were identified. Main outcome measures Determination of surgical approach, synthetic mesh implantation, and assessment of the duration of surveillance for mortality and reoperation rates following MUS implantation. Results In the TPI cohort analysis, 3,331 patients were identified. Surgical approach per site was retropubic (42% to 77%), transobturator (6% to 44%), single incision (0% to 24%), and adjustable sling (0% to <4%). Concordance rates for TPI using chart review were 71%–90% at each site for the surgical approach and 28%–85% for synthetic mesh implantation. Patient follow-up observation rates for mortality and reoperation ranged from 22% to 36% at 90 days, 15% to 30% at 365 days, and 8% to 19% at 730 days. Conclusion Using EHR data alone, identification of medical devices and surgical approaches was feasible among women with MUS surgery for SUI, but long-term follow-up ascertainment rates were low. Medical device surveillance using EHR data should be evaluated in the context of the clinical use case, as applicability may vary.

Objective To characterise the changing trends in the pharmacological management of SLE in the USA between 2007 and 2023 as new treatment options emerged. Methods In a retrospective cohort study using data from OptumLabs Data Warehouse, we characterised the annual prevalent (ie, all) and incident (ie, new) use of antimalarials, glucocorticoids and immunosuppressive medications among patients with SLE from 2007 to 2023 and assessed for changing trends over time. Results We identified 19 122 adults with SLE; they were 51.2 (SD 16.1) years of age, 89% were female, 61.3% were White, 18.5% were Black and 13.1% were Hispanic. The proportion of prevalent users of antimalarials has decreased from 79.4% in 2007 to 77.2% in 2023 (p=0.0055), while the proportion of incident users fluctuated between a lowest 5.8% in 2021 and a highest 8.1% in 2008 (p=0.008). The proportion of prevalent users of glucocorticoids increased from 64.6% in 2007 to 66.7% in 2023 (p=0.0132), as did the proportion of incident users (12.4% in 2007 to 21.7% in 2023; p<0.0001). The use of cyclophosphamide (2.0% in 2007 to 0.4% in 2023, p<0.0001) has decreased; the use of mycophenolate mofetil (7.7% in 2007 to 10.3% in 2023, p<0.0001), rituximab (1.4% in 2007 to 2.1% in 2023, p<0.0001) and belimumab (0.8% in 2011 to 6.1% in 2023, p=0.0001) has increased. Conclusions Despite increasing availability of alternative treatment options, patients with SLE in the USA increasingly rely on glucocorticoid-based therapy. Efforts to improve the use of antimalarials and steroid-sparing immunosuppressants are needed.

Background: Epidemiologic studies have demonstrated that the incidence of heart failure varies by race and ethnicity, with the highest incidence occurring in blacks. However, whether these racial and ethnic variations extend to commercially insured populations and whether differences in early outcomes after diagnosis exist requires further exploration. Methods: We utilized administrative claims data from a large U.S. commercial insurance database to retrospectively identify privately insured and Medicare Advantage patients who were diagnosed with heart failure between 2006 and 2014. Published claims-based algorithms were used to identify patients with incident HF and categorize reasons for hospitalization after diagnosis. Results: Among 148,827 patients with incident heart failure (mean age 72.2 years, 51% women), 70% were white, 15% black, 6% Hispanic, 3% Asian and 6% had unknown race/ ethnicity. The incidence of heart failure during the study period was 3.7 per 1000 person-years and was highest among blacks, followed by whites, Hispanics and Asians (9.9, 3.6, 2.5, and 2.0 per 1000 person-years, respectively). In total, 37% of patients were hospitalized at least once in the first year after diagnosis for a total of 93,358 hospitalizations. HF was the most common reason for hospitalization (13% of all hospitalizations), followed by arrhythmia (5%), sepsis (5%), pneumonia (4%), COPD (3%) and acute renal failure (3%). Reasons for hospitalization were similar across racial and ethnic groups. The rate of hospitalizations was highest the first month after diagnosis and then gradually declined. Black patients had the highest rates of hospitalization, while Asians had the lowest (Figure). Conclusions: Even among a commercially insured population that likely have fewer barriers to care, black patients had a higher incidence of HF and higher rates of hospitalization after initial diagnosis compared with other racial and ethnic groups.

Abstract Objective To emulate the GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) trial using real world data before its publication. GRADE directly compared second line glucose lowering drugs for their ability to lower glycated hemoglobin A 1c (HbA 1c ). Design Observational study. Setting OptumLabs® Data Warehouse (OLDW), a nationwide claims database in the US, 25 January 2010 to 30 June 2019. Participants Adults with type 2 diabetes and HbA 1c 6.8-8.5% while using metformin monotherapy, identified according to the GRADE trial specifications, who also used glimepiride, liraglutide, sitagliptin, or insulin glargine. Main outcome measures The primary outcome was time to HbA 1c ≥7.0%. Secondary outcomes were time to HbA 1c >7.5%, incident microvascular complications, incident macrovascular complications, adverse events, all cause hospital admissions, and all cause mortality. Propensity scores were estimated using the gradient boosting machine method, and inverse propensity score weighting was used to emulate randomization of the treatment groups, which were then compared using Cox proportional hazards regression. Results 8252 people were identified (19.7% of adults starting the study drugs in OLDW) who met eligibility criteria for the GRADE trial (glimepiride arm=4318, liraglutide arm=690, sitagliptin arm=2993, glargine arm=251). The glargine arm was excluded from analyses owing to small sample size. Median times to HbA 1c ≥7.0% were 442 days (95% confidence interval 394 to 480 days) for glimepiride, 764 (741 to not calculable) days for liraglutide, and 427 (380 to 483) days for sitagliptin. Liraglutide was associated with lower risk of reaching HbA 1c ≥7.0% compared with glimepiride (hazard ratio 0.57, 95% confidence interval 0.43 to 0.75) and sitagliptin (0.55, 0.41 to 0.73). Results were consistent for the secondary outcome of time to HbA 1c >7.5%. No significant differences were observed among treatment groups for the remaining secondary outcomes. Conclusions In this emulation of the GRADE trial, liraglutide was statistically significantly more effective at maintaining glycemic control than glimepiride or sitagliptin when added to metformin monotherapy. Generating timely evidence on medical treatments using real world data as a complement to prospective trials is of value.

Background This study aimed to compare percutaneous left atrial appendage occlusion (LAAO) with non‐vitamin K antagonist oral anticoagulants among patients with atrial fibrillation. Methods and Results Using a US administrative database, 562 850 patients with atrial fibrillation were identified, among whom 8397 were treated with LAAO and 554 453 were treated with non‐vitamin K antagonist oral anticoagulants between March 13, 2015 and December 31, 2018. Propensity score overlap weighting was used to balance baseline characteristics. The primary outcome was a composite end point of ischemic stroke or systemic embolism, major bleeding, and all‐cause mortality. The mean age was 76.4±7.6 years; 280 097 (49.8%) were female. Mean follow‐up was 1.5±1.0 years. LAAO was associated with no significant difference in the risk of the primary composite end point (hazard ratio [HR], 0.93 [0.84–1.03]), or the secondary outcomes including ischemic stroke/systemic embolism (HR, 1.07 [0.81–1.41]), and intracranial bleeding (HR, 1.08 [0.72–1.61]). LAAO was associated with a higher risk of major bleeding (HR, 1.22 [1.05–1.42], P =0.01) and a lower risk of mortality (HR, 0.73 [0.64–0.84], P <0.001). The lower risk of mortality associated with LAAO was most pronounced in patients with a prior history of intracranial bleeding. Conclusions In comparison to non‐vitamin K antagonist oral anticoagulants, LAAO was associated with no significant difference in the risk of the composite outcome and a lower risk of mortality, which suggests LAAO might be a reasonable option in select patients with atrial fibrillation. The observation of higher bleeding risk associated with LAAO highlights the need to optimize postprocedural antithrombotic regimens as well as systematic efforts to assess and address bleeding predispositions.

Introduction Cognitive behavioural therapy for insomnia (CBT-I) is effective at treating chronic insomnia, yet in-person CBT-I can often be challenging to access. Prior studies have used technology to bridge barriers but have been unable to extensively assess the impact of the digital therapeutic on real-world patient experience and multidimensional outcomes. Among patients with insomnia, our aim is to determine the impact of a prescription digital therapeutic (PDT) (PEAR-003b, FDA-authorised as Somryst; herein called PDT) that provides mobile-delivered CBT-I on patient-reported outcomes (PROs) and healthcare utilisation. Methods and analysis We are conducting a pragmatically designed, prospective, multicentre randomised controlled trial that leverages Hugo, a unique patient-centred health data-aggregating platform for data collection and patient follow-up from Hugo Health. A total of 100 participants with insomnia from two health centres will be enrolled onto the Hugo Health platform, provided with a linked Fitbit (Inspire 2) to track activity and then randomised 1:1 to receive (or not) the PDT for mobile-delivered CBT-I (Somryst). The primary outcome is a change in the insomnia severity index score from baseline to 9-week postrandomisation. Secondary outcomes include healthcare utilisation, health utility scores and clinical outcomes; change in sleep outcomes as measured with sleep diaries and a change in individual PROs including depressive symptoms, daytime sleepiness, health status, stress and anxiety. For those allocated to the PDT, we will also assess engagement with the PDT. Ethics and dissemination The Institutional Review Boards at Yale University and the Mayo Clinic have approved the trial protocol. This trial will provide important data to patients, clinicians and policymakers about the impact of the PDT device delivering CBT-I on PROs, clinical outcomes and healthcare utilisation. Findings will be disseminated to participants, presented at professional meetings and published in peer-reviewed journals. Trial registration number NCT04909229 .

Introduction Opioid analgesics are often used to treat moderate-to-severe acute non-cancer pain; however, there is little high-quality evidence to guide clinician prescribing. An essential element to developing evidence-based guidelines is a better understanding of pain management and pain control among individuals experiencing acute pain for various common diagnoses. Methods and analysis This multicentre prospective observational study will recruit 1550 opioid-naïve participants with acute pain seen in diverse clinical settings including primary/urgent care, emergency departments and dental clinics. Participants will be followed for 6 months with the aid of a patient-centred health data aggregating platform that consolidates data from study questionnaires, electronic health record data on healthcare services received, prescription fill data from pharmacies, and activity and sleep data from a Fitbit activity tracker. Participants will be enrolled to represent diverse races and ethnicities and pain conditions, as well as geographical diversity. Data analysis will focus on assessing patients’ patterns of pain and opioid analgesic use, along with other pain treatments; associations between patient and condition characteristics and patient-centred outcomes including resolution of pain, satisfaction with care and long-term use of opioid analgesics; and descriptive analyses of patient management of leftover opioids. Ethics and dissemination This study has received approval from IRBs at each site. Results will be made available to participants, funders, the research community and the public. Trial registration number NCT04509115 .

Objective We examined the association between stay-at-home order implementation and the incidence of COVID-19 infections and deaths in rural versus urban counties of the United States. Design We used an interrupted time-series analysis using a mixed effects zero-inflated Poisson model with random intercept by county and standardised by population to examine the associations between stay-at-home orders and county-level counts of daily new COVID-19 cases and deaths in rural versus urban counties between 22 January 2020 and 10 June 2020. We secondarily examined the association between stay-at-home orders and mobility in rural versus urban counties using Google Community Mobility Reports. Interventions Issuance of stay-at-home orders. Primary and secondary outcome measures Co-primary outcomes were COVID-19 daily incidence of cases (14-day lagged) and mortality (26-day lagged). Secondary outcome was mobility. Results Stay-at-home orders were implemented later (median 30 March 2020 vs 28 March 2020) and were shorter in duration (median 35 vs 54 days) in rural compared with urban counties. Indoor mobility was, on average, 2.6%–6.9% higher in rural than urban counties both during and after stay-at-home orders. Compared with the baseline (pre-stay-at-home) period, the number of new COVID-19 cases increased under stay-at-home by incidence risk ratio (IRR) 1.60 (95% CI, 1.57 to 1.64) in rural and 1.36 (95% CI, 1.30 to 1.42) in urban counties, while the number of new COVID-19 deaths increased by IRR 14.21 (95% CI, 11.02 to 18.34) in rural and IRR 2.93 in urban counties (95% CI, 1.82 to 4.73). For each day under stay-at-home orders, the number of new cases changed by a factor of 0.982 (95% CI, 0.981 to 0.982) in rural and 0.952 (95% CI, 0.951 to 0.953) in urban counties compared with prior to stay-at-home, while number of new deaths changed by a factor of 0.977 (95% CI, 0.976 to 0.977) in rural counties and 0.935 (95% CI, 0.933 to 0.936) in urban counties. Each day after stay-at-home orders expired, the number of new cases changed by a factor of 0.995 (95% CI, 0.994 to 0.995) in rural and 0.997 (95% CI, 0.995 to 0.999) in urban counties compared with prior to stay-at-home, while number of new deaths changed by a factor of 0.969 (95% CI, 0.968 to 0.970) in rural counties and 0.928 (95% CI, 0.926 to 0.929) in urban counties. Conclusion Stay-at-home orders decreased mobility, slowed the spread of COVID-19 and mitigated COVID-19 mortality, but did so less effectively in rural than in urban counties. This necessitates a critical re-evaluation of how stay-at-home orders are designed, communicated and implemented in rural areas.

Background: Although percutaneous coronary intervention (PCI) has not been shown to reduce the risk of death and myocardial infarction (MI) for stable coronary artery disease (CAD), many patients believe that PCI is a life-saving procedure. PCI for stable CAD is known to improve patients’ quality of life more rapidly than medications alone. We conducted a randomized trial to assess the impact of a decision aid (DA) compared to usual care (UC) for the treatment of stable CAD when there is a choice between PCI and optimal medical therapy (OMT). Methods: The PCI Choice trial was a prospective, randomized trial comparing the effects of DA versus UC. The DA was designed with a user-centered approach for an in-visit consultation, involving patients and clinicians throughout the development process. The final DA included information on myocardial infarction (MI), death and quality of life outcomes for PCI with OMT vs. OMT alone in the treatment of stable angina, stratified by angina type. Risks of procedure, bleeding, stent thrombosis, and need for future procedures were also depicted. The primary outcome was patient knowledge, measured by pre- and post-visit surveys. Additional outcomes included decisional conflict, patient satisfaction, preferred decision making style, and treatment decision. Results: A total of 110 patients were enrolled; mean age was 68.3 years and 26% of patients were women. At baseline, most patients had CCS Class I/II angina and were on a mean of two anti-anginal medications (2.3, SD 1.2). Knowledge increased among patients receiving DA compared to UC (63% vs. 44% p=0.0003). Specific knowledge about the impact of PCI for stable angina on death and MI was higher in both groups compared to prior studies (54% DA, 46% UC, p=0.45; 12% prior). Patient satisfaction was significantly higher in the DA group vs. UC (72% vs 40%, p=0.004). Decisional conflict was greater than in non-procedural DA trials, and was not different between the two arms (p=.43). Following exposure to DA, patients’ preference for sharing decision making tended to change more with DA (55% to 65%) than with UC (56% to 59%). While the proportion of patients choosing PCI over OMT was nearly half in both groups, there were fewer patients that remained undecided with DA (18% vs. 4%; p=0.14 overall difference). Conclusions: Exposure to a DA for the choice of PCI vs. optimal medical therapy in stable CAD improved patient knowledge and satisfaction and decreased uncertainty, without reducing the rate of PCI. Use of the DA in a larger patient population may further delineate impact on outcomes such as treatment choice, geographic variation and cost.