Fournier JP, Gaultier A, Riche VP
… +3 more, Tessier P, Rat C, Nguyen-Soenen J
JAMA Intern Med
· 2026 Jun · PMID 41973459
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IMPORTANCE: Inappropriate use of proton pump inhibitors (PPIs) is associated with severe adverse drug reactions and may significantly increase health care costs. Deprescribing should be considered when inappropriate use...IMPORTANCE: Inappropriate use of proton pump inhibitors (PPIs) is associated with severe adverse drug reactions and may significantly increase health care costs. Deprescribing should be considered when inappropriate use is identified. OBJECTIVE: To evaluate the effectiveness of a patient- and general practitioner (GP)-facing intervention in reducing potentially inappropriate PPI use in primary care. DESIGN, SETTING, AND PARTICIPANTS: This pragmatic, cluster-randomized, open-label, clinical trial was conducted between November 12, 2020, and November 11, 2021. Participants were adults aged 18 years or older with at least 1 year of PPI use in GP practices in 2 regions of western France, and their GPs were included. Data were analyzed from January to July 2025. INTERVENTIONS: GP practices were randomized to 3 groups in a 1:1:1 ratio as follows: (1) a patient- and GP-facing deprescribing intervention combining a patient education brochure on PPI deprescribing posted directly to patients with a letter outlining a PPI deprescribing algorithm sent to their GPs; (2) a GP-facing intervention, in which only the GP received the letter and algorithm; or (3) usual care. MAIN OUTCOMES AND MEASURES: The primary outcome was PPI dose reduction, defined as a 50% or more reduction in annual PPI use, measured in defined daily doses (DDDs) and proxied by reimbursement claims. Secondary measures included Gastroesophageal Reflux Disease Impact Scale (GIS) scores, assessed in a 10% sample. RESULTS: A total of 1498 GPs and 34 409 patients were included from 683 primary care practices. The mean (SD) patient age was 68.6 (14.0) years, and 19 507 (56.7%) were female. Mean (SD) baseline annual PPI use was 413.7 (113.9) DDDs. PPI dose reduction was higher in the patient- and GP-facing intervention group compared with the usual care groups (1710 of 11 442 patients [14.9%] vs 825 of 11 732 [7.0%]; adjusted absolute difference, 6.9%; 95% CI, 5.7%-8.3%; P < .001) and with the GP-facing intervention (1710 of 11 442 patients [14.9%] vs 862 of 11 235 [7.7%]; adjusted absolute difference, 6.7%; 95% CI, 5.4%-8.2%, P < .001). GIS scores did not significantly differ between groups. CONCLUSIONS AND RELEVANCE: This randomized clinical trial found that the patient- and GP-facing intervention was effective in reducing potentially inappropriate PPI use without any meaningful impact on long-term gastroesophageal reflux disease activity. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04255823.
Verma M, Navarro V, Kosinski A
… +26 more, Taddei T, Kalman R, Barritt Iv AS, Jakab S, Serper M, Orman E, Balakrishnan M, Rakoski M, Rockey D, Hunt K, Cabrera R, Aytaman A, John B, Baffy G, Nathan R, Tapper E, Roytman M, McGuire B, Hoppmann N, Woodrell C, Bakitas M, Yue Y, Reeve B, Lin L, Tantala R, Volk M
JAMA Intern Med
· 2026 Jun · PMID 41973444
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IMPORTANCE: Palliative care improves quality of life (QoL) in advanced illnesses, but data in end-stage liver disease (ESLD) are limited. It is unknown whether palliative care delivered by hepatologists is effective when...IMPORTANCE: Palliative care improves quality of life (QoL) in advanced illnesses, but data in end-stage liver disease (ESLD) are limited. It is unknown whether palliative care delivered by hepatologists is effective when compared with palliative care specialists. OBJECTIVE: To compare the effectiveness of palliative care delivered by trained hepatologists with the care delivered by conventional palliative care specialists in improving QoL at 3 months. DESIGN, SETTING, AND PARTICIPANTS: This comparative effectiveness cluster randomized trial for US patients treated for ESLD in 19 US medical centers compared a palliative care intervention delivered by palliative care-trained hepatologists (hepatologist group; 11 centers) with palliative care specialists (consultative group; 8 centers). Eligible patients were US adults with either decompensated cirrhosis or hepatocellular cancer who had a life expectancy of at least 6 months, had not received or scheduled liver transplantation, or had not received palliative care in the prior 3 months. Hepatologists in hepatologist group alone received primary palliative care training. Data collection occurred from January 2019 through June 2025; analysis was conducted from July to September 2025. INTERVENTION: Participants received 4 palliative care visits over 3 months delivered by either palliative care-trained hepatologists or palliative care specialists, using a structured palliative care checklist. MAIN OUTCOMES AND MEASURES: Superiority or a priori noninferiority of the effect of palliative care delivered by hepatologists vs palliative care specialists on change in QoL at 3 months, measured by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) total score (higher scores indicating better QoL). Secondary outcomes included change in symptom burden, distress, depression, satisfaction from baseline to 3 months, and mortality. RESULTS: A total of 935 patients were enrolled (mean [SD] age, 63.0 [10.3] years; 275 female [29%]; 130 Hispanic ethnicity [14%]; 144 Black [15%], 736 White [79%]). From baseline to 3 months, QoL improved in both groups (adjusted mean: hepatologist, 8.01 [95% CI, 5.38 to 10.65]; consultative, 7.02 [95% CI, 4.34 to 9.71]; both P < .001). Although superiority was not found in change in QoL, prespecified noninferiority analysis showed that the improvement in the hepatologist group was noninferior to the consultative group (adjusted mean difference, 0.98 [95% CI, -2.86 to 4.83]; P = .01). Symptom burden (adjusted mean difference, -7.52 [95% CI, -9.89 to -5.15] vs -5.31 [95% CI, -7.60 to -3.03]) and depression (adjusted mean difference, -1.18 [95% CI, -1.78 to -0.57] vs -0.90 [95% CI, -1.49 to -0.31]) improved in both groups, without significant between-group differences. Patient satisfaction improved more in the hepatologist group compared with the palliative care group (adjusted mean difference, 3.37 [95% CI, 2.24 to 4.49] vs 0.91 [95% CI, -0.15 to 1.96]; P = .002). Mortality at 3 months was similar in both groups. CONCLUSIONS AND RELEVANCE: This cluster trial found that palliative care delivered by trained hepatologists was comparable with palliative care delivered by palliative care specialists in improving QoL in patients with ESLD and was associated with greater improvement in patient satisfaction, demonstrating the effectiveness among enrolled patients. TRIAL REGISTRATION: ClinicalTrials.Gov Identifier: NCT03540771.
Ralph LJ, Baba CF, Ehrenreich K
… +10 more, Morris N, Biggs MA, Blanchard K, Hernández E, Kapp N, Kromenaker T, Perritt J, Raymond E, White K, Grossman D
JAMA Intern Med
· 2026 Apr · PMID 41941214
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Hong D, Cantos K, Morgenstern D
… +9 more, Dasgupta S, Kesselheim AS, Song Z, Tong AY, Chadaram R, Potter D, Patorno E, Avorn J, Rome BN
JAMA Intern Med
· 2026 Apr · PMID 41941210
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IMPORTANCE: In Medicare, out-of-pocket spending for insulin was capped at $35 per month for some patients in 2021 and for all patients in 2023. However, independent evaluations of the federal cap and clinical outcomes ar...IMPORTANCE: In Medicare, out-of-pocket spending for insulin was capped at $35 per month for some patients in 2021 and for all patients in 2023. However, independent evaluations of the federal cap and clinical outcomes are lacking. OBJECTIVE: To measure changes in patient spending, insulin use, and health outcomes associated with the $35 monthly insulin out-of-pocket cap. DESIGN, SETTING, AND PARTICIPANTS: This cohort study used an interrupted time-series analysis of data from Medicare Part D beneficiaries with type 2 diabetes (T2D) included in the IQVIA national longitudinal open claims database from 2019 to 2023; a subset of patients had linked data from ambulatory electronic medical records. The analysis was performed between January and July 2025. EXPOSURES: Implementation of the $35 monthly insulin out-of-pocket cap to some beneficiaries in January 2021 and all beneficiaries in January 2023. MAIN OUTCOMES AND MEASURES: Outcomes included mean quarterly insulin out-of-pocket spending, mean daily units of insulin, mean hemoglobin A1c level, and incidence rates of severe hypoglycemia resulting in hospitalizations or emergency department visits. Changes were assessed using segmented regression with generalized estimating equations, adjusted for patient age and sex and within-year seasonal variation. RESULTS: The study included 4.8 million patients, with a median quarterly cohort size of 1 393 402 patients (range, 1 261 976-1 475 460). In the first quarter of 2019, the baseline cohort included 707 416 males (51.1%), with 711 075 patients (51.3%) aged 65 to 74 years. Mean quarterly insulin out-of-pocket spending was $192.66 (95% CI, $192.63-$192.68) at baseline and declined by $47.90 (95% CI, -$48.95 to -$46.84) in 2021 and by another $58.59 (95% CI, -$59.91 to -$57.27) in 2023. Among all patients with T2D, mean daily insulin use was 12.86 (95% CI, 12.86-12.87) units at baseline and increased by 0.23 (95% CI, 0.15-0.31) units in 2023. Among a subset of 207 197 patients with linked electronic medical record data, mean hemoglobin A1c level was 7.28% (95% CI, 7.28%-7.28%) at baseline and decreased by 0.06% (95% CI, -0.08% to -0.03%) after 2023. There were corresponding modest increases in rates of severe hypoglycemic events. CONCLUSIONS AND RELEVANCE: In this cohort study, a $35 monthly insulin out-of-pocket cap was found to be associated with significantly lower insulin out-of-pocket spending, increased access to insulin, and decreased blood glucose levels among Medicare beneficiaries with T2D. These findings suggest federal cost-sharing policies could improve access and adherence to essential medications in diabetes and other chronic diseases.
IMPORTANCE: Orthostatic hypotension is a common but underrecognized condition that increases with age and is associated with a lower quality of life, falls, and increased mortality. The frequent coexistence of supine hyp...IMPORTANCE: Orthostatic hypotension is a common but underrecognized condition that increases with age and is associated with a lower quality of life, falls, and increased mortality. The frequent coexistence of supine hypertension and postprandial hypotension with orthostatic hypotension makes it a challenging condition to manage. OBSERVATIONS: Testing for orthostatic hypotension should be done in patients with orthostatic symptoms (eg, vision changes and dizziness that occur only when upright and improve when seated or lying down), as well as asymptomatic patients in high-risk groups such as adults with frailty who are older than 70 years, individuals with neurodegenerative or autonomic disorders, and patients with unexplained falls. Patients with orthostatic hypotension should be screened for postprandial hypotension and supine hypertension to inform the treatment approach. Nonpharmacological strategies, such as medication review, increased salt and fluid intake, compression garments, and behavioral modifications, serve as fundamental approaches to treat orthostatic hypotension. Midodrine and droxidopa are the only US Food and Drug Administration-approved medications for orthostatic hypotension, but other medications (eg, fludrocortisone, atomoxetine, pyridostigmine) are used off label as part of an individualized treatment plan. Treatment targets in orthostatic hypotension are focused not on blood pressure measurements but on symptom relief and fall prevention. CONCLUSIONS AND RELEVANCE: All patients with orthostatic symptoms-along with other select patient groups-should be evaluated for orthostatic hypotension. Nonpharmacological treatments are first line, and medication decisions should be tailored based on clinical presentation and relevant comorbidities.