NEJM evidence最新文献

{"title":"A Vaccine to Block <i>Plasmodium falciparum</i> Transmission.","authors":"Sara A Healy, Issaka Sagara, Mahamadoun H Assadou, Abdoulaye Katile, Mamady Kone, Alemush Imeru, Jennifer L Kwan, Bruce J Swihart, Jonathan Fintzi, Gail E Potter, Amatigue Zeguimé, Amagana Dolo, Balla Diarra, David L Narum, Kelly M Rausch, Nicholas J MacDonald, Daming Zhu, Rathy Mohan, Ismaila Thera, Robert D Morrison, Irfan Zaidi, Justin Y A Doritchamou, Daman Sylla, Jen C C Hume, Mamadou B Coulibaly, Danielle Morelle, Marc Lievens, Ogobara K Doumbo, Patrick E Duffy","doi":"10.1056/EVIDoa2400188","DOIUrl":"10.1056/EVIDoa2400188","url":null,"abstract":"<p><strong>Background: </strong>Malaria vaccines that target parasite development in mosquitoes offer a strategy to block disease transmission and support control, elimination, and eradication. In this article, we evaluate Pfs230D1-exoprotein A (EPA) and Pfs25-EPA for safety, immunogenicity, and field efficacy in Malian adults.</p><p><strong>Methods: </strong>We first conducted a comparator-controlled, dose-escalating pilot safety trial, assessing Pfs25-EPA (16 vs. 47 μg) and Pfs230D1-EPA (13 vs. 40 μg), and their combinations, each formulated in the adjuvant AS01, at a 0-, 1-, and 6-month schedule. We then conducted a randomized, double-blind, comparator-controlled main trial to evaluate two Pfs230D1-EPA/AS01 regimens on a 0-, 1-, 4-, 16-month schedule. Pfs230D1-full, consisting of 40 μg of Pfs230D1-EPA plus 50 μg of AS01 for each dose, versus Pfs230D1-fractional, identical to Pfs230D1-full except for the third dose that used 8 μg of Pfs230D1-EPA and 10 μg of AS01. Primary end points were safety and reactogenicity (as-treated population), and secondary end points (as-randomly-assigned population) were immunogenicity by enzyme-linked immunosorbent assay, serum activity by mosquito standard membrane feeding assay (SMFA), and efficacy by direct skin feeding assay (DSF).</p><p><strong>Results: </strong>In the pilot safety trial, 65 participants received injections (45 Pfs230D1 and/or Pfs25; 20 comparator). In the main phase, 236 participants received injections (56 Pfs230D1-full; 61 Pfs230D1-fractional; 119 comparator). No serious adverse events (SAEs) occurred in vaccinees in the pilot or main phase. Pfs230D1-full and Pfs230D1-fractional regimens induced antibody responses and transmission-reducing activity (based on SMFA) detectable up to approximately 1 year post-vaccination 3. Primary efficacy analysis showed combined Pfs230D1-full and Pfs230D1-fractional groups were not associated with reductions in mosquito positivity rate in the first 6 weeks of year 1 (efficacy, -1.55; 95% confidence interval [CI], -11.05 to 0.46). In the Pfs230D1-full group, DSF positivity was lower by 72.5% (95% CI, 30.4 to 89.1), and the proportion of infected mosquitoes was lower by 77.3% (95% CI, 19.5 to 93.6) over two transmission seasons.</p><p><strong>Conclusions: </strong>In this trial, Pfs230D1-EPA/AS01 regimens did not result in SAEs and generated antibody responses and functional activity that persisted for up to 1 year postvaccination. Although the primary efficacy estimate did not demonstrate a reduction in parasite transmission during the first 6 weeks of follow-up, the full dosing regimen was associated with reduced transmission events and infected mosquitoes over 2 years. (Funded by the National Institute of Allergy and Infectious Diseases and others; ClinicalTrials.gov ID, NCT02942277.).</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 7","pages":"EVIDoa2400188"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478150","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sulopenem versus Amoxicillin/Clavulanate for the Treatment of Uncomplicated Urinary Tract Infection.","authors":"Sailaja Puttagunta, Steven I Aronin, Jayanti Gupta, Anita F Das, Kalpana Gupta, Michael W Dunne","doi":"10.1056/EVIDoa2400414","DOIUrl":"10.1056/EVIDoa2400414","url":null,"abstract":"<p><strong>Background: </strong>Existing antibiotics for uncomplicated urinary tract infections are becoming less reliably effective owing to increasing antimicrobial resistance. Our objective was to evaluate the safety and efficacy of sulopenem/probenecid for uncomplicated urinary tract infections.</p><p><strong>Methods: </strong>We conducted a double-blind, randomized, controlled, noninferiority trial of 5 days of sulopenem versus amoxicillin/clavulanate for women with uncomplicated urinary tract infection. The primary end point was overall success, defined as combined clinical cure and microbiologic eradication by day 12, evaluated in the microbiologic-modified intent-to-treat population, which comprised all randomly assigned patients who received any trial medication and had a positive urine culture with 10⁵ colony-forming units (CFU)/ml or more of an Enterobacterales uropathogen (e.g., <i>Escherichia coli</i>, <i>Klebsiella</i> species).</p><p><strong>Results: </strong>A total of 2222 patients were enrolled, and the median age was 51 years (interquartile range, 35-62 years). Ninety-one (9.2%) patients in the primary population (microbiologic-modified intent-to-treat population), the combined population of patients with a positive baseline urine culture and without regard to amoxicillin/clavulanate susceptibility, had a baseline pathogen resistant to three or more classes of antibiotics. Overall success in the microbiologic-modified intent-to-treat population occurred in 318 of 522 (60.9%) participants treated with sulopenem versus 260 of 468 (55.6%) participants treated with amoxicillin/clavulanate (difference, 5.4 percentage points; 95% confidence interval [CI], -0.8 to 11.5), meeting criteria for noninferiority. In the primary population with a baseline uropathogen susceptible to amoxicillin/clavulanate, success occurred in 296 of 480 (61.7%) participants treated with sulopenem versus 243 of 442 (55.0%) participants treated with amoxicillin/clavulanate (difference, 6.7 percentage points; 95% CI, 0.3 to 13.0). In the primary population with a baseline uropathogen not susceptible to amoxicillin/clavulanate, success occurred in 22 of 42 (52.4%) patients treated with sulopenem versus 17 of 25 (68.0%) patients treated with amoxicillin/clavulanate (difference, -15.6 percentage points; 95% CI, -37.5 to 9.1]. Treatment-emergent adverse events occurred more frequently with sulopenem compared with amoxicillin/clavulanate, including diarrhea (8.1% vs. 4.1%), nausea (4.3% vs. 2.9%), and headache (2.2% vs. 1.5%).</p><p><strong>Conclusions: </strong>Sulopenem was noninferior to amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection, but was associated with more frequent mild adverse events. (Funded by Iterum Therapeutics; REASSURE ClinicalTrials.gov number, NCT05584657.).</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 7","pages":"EVIDoa2400414"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intermediate-Dose Cytarabine as Postinduction AML Therapy.","authors":"Mathilde Hunault, Cécile Pautas, Sarah Bertoli, Pierre-Yves Dumas, Emmanuel Raffoux, Marie-Anne Hospital, Tony Marchand, Maël Heiblig, Sylvain Chantepie, Martin Carré, Pierre Peterlin, Maria-Pilar Gallego-Hernanz, Emilie Lemasle, Romain Guièze, Célestine Simand, Pascal Turlure, Anne Huynh, Thibaut Leguay, Raynier Devillier, Stéphanie Nguyen Quoc, Nicolas Duployez, Isabelle Luquet, Dominique Penther, Karine Celli-Lebras, Ariane Mineur, Nicole Raus, Claude Gardin, Gérard Socié, Jean-Yves Cahn, Norbert Ifrah, Norbert Vey, Régis Peffault de Latour, Eric Delabesse, Claude Preudhomme, Jean-François Hamel, Arnaud Pigneux, Christian Récher, Hervé Dombret","doi":"10.1056/EVIDoa2400326","DOIUrl":"10.1056/EVIDoa2400326","url":null,"abstract":"<p><strong>Background: </strong>We conducted a randomized controlled trial to compare intermediate doses (IDAC) with high doses of cytarabine (HDAC) as postinduction therapy in patients 18 to 60 years of age with newly diagnosed acute myeloid leukemia (AML). The main objectives were to evaluate noninferiority in overall survival (OS) after IDAC and safety.</p><p><strong>Methods: </strong>Patients 18 to 60 years of age with newly diagnosed AML, except those with core-binding factor, acute promyelocytic, Philadelphia chromosome-positive, or post-myeloproliferative neoplasm AML, were eligible. After the induction course, we randomly assigned patients to either IDAC (1500 mg/m²/12 hours) or HDAC (3000 mg/m²/12 hours). Patients with intermediate- and adverse-risk AML were eligible for allogeneic hematopoietic stem cell transplantation (HSCT) in first remission. The primary end point was OS in a predefined per-protocol analysis population. The primary analyses were performed in 1132 randomly assigned patients, with a noninferiority outcome adjusted on the European Leukemia Net (ELN) 2022 risk group, the use of induction anthracycline, the response to induction, and HSCT as a function of time following treatment.</p><p><strong>Results: </strong>At 5 years, OS was estimated at 59.3% (95% confidence interval [CI], 55.0 to 63.3) in the IDAC group versus 57.5% (95% CI, 53.3 to 61.5) in the HDAC group (adjusted hazard ratio, 0.96; 95% CI, 0.80 to 1.15; noninferiority test, P=0.0042). A preplanned analysis was unable to detect any interaction between IDAC or HDAC treatment effect and patient subgroups, including those defined by the ELN 2022 risk group or response to induction prior to random assignment. In addition, the severity of chemotherapy-induced myelosuppression and the incidence of related adverse events were lower after IDAC.</p><p><strong>Conclusions: </strong>Our trial shows noninferior outcomes in patients 18 to 60 years of age with newly diagnosed AML treated with low- versus high-dose cytarabine; this occurred with similar or lower toxicities. (Funded by the Regional Clinical Research Office, Angers and others; EudraCT number, 2014-000699-24; ClinicalTrials.gov number, NCT02416388.).</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 7","pages":"EVIDoa2400326"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478152","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Interpreting Changes to Lung Adenocarcinoma Prognosis over Two Decades.","authors":"Fiona Stanaway, Armando Teixeira-Pinto","doi":"10.1056/EVIDe2500093","DOIUrl":"https://doi.org/10.1056/EVIDe2500093","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 7","pages":"EVIDe2500093"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478077","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Nudge toward Quality Primary Care.","authors":"William K Silverstein, Michael P Hillmer","doi":"10.1056/EVIDe2500057","DOIUrl":"https://doi.org/10.1056/EVIDe2500057","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 6","pages":"EVIDe2500057"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144152969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment of Intractable Cancer Pain with Resiniferatoxin - An Interim Study.","authors":"Andrew J Mannes, John D Heiss, Ann Berger, Christine C Alewine, John A Butman, Marybeth S Hughes, Nusrat Rabbee, Christina Hayes, Tracy S Williams, Matthew R Sapio, Michael J Iadarola","doi":"10.1056/EVIDoa2400423","DOIUrl":"10.1056/EVIDoa2400423","url":null,"abstract":"<p><strong>Background: </strong>A substantial number of patients with advanced cancer suffer from refractory pain despite comprehensive medical management. In this article, we evaluate a nonopioid analgesic, resiniferatoxin (RTX), a potent agonist of the transient receptor potential vanilloid 1 (TRPV1) ion channel, which selectively interrupts nociceptive activity transmitted by a subpopulation of dorsal root ganglion neurons.</p><p><strong>Methods: </strong>In this interim analysis of a first-in-human, open-label, Phase 1 study, 19 patients with refractory cancer pain localized to the abdomen and/or lower extremities received one dose of intrathecal RTX. The primary outcome was safety. Secondary outcomes were efficacy assessed over the course of the study using a numerical rating scale measuring the \"worst pain\" over a 24-hour period. This is a 0 to 10 scale where 0 is \"no pain\" and 10 is the \"worst pain imaginable.\" Opioid consumption was measured as morphine equivalents used to control pain.</p><p><strong>Results: </strong>Over 188 days after RTX injection, a total of 213 treatment-emergent adverse events (AEs) were reported among 19 patients treated, including 37 serious adverse events in 14 patients. Nine deaths occurred an average of 70 days after treatment (range from 11 to 140 days). Many of these events, including death, are consistent with the course of advanced cancer. At least one AE occurred in all 19 patients. Three patients experienced loss of heat sensitivity in the dermatomes exposed to RTX (grades I and II). Seven patients experienced urinary retention lasting more than 24 hours (three were grade III). Five patients had AEs related to a transient increase in the electrocardiographic QT interval that resolved within 24 hours (grades I and II). The only grade IV AE was an unstageable decubitus ulcer. RTX was associated with decreased \"worst\" pain intensity by 38% (pretreatment 8.4±0.4 vs. posttreatment 5.2±0.6) and reduced opioid consumption by 57% measured at posttreatment day 15.</p><p><strong>Conclusions: </strong>Intrathecal RTX is a single-administration, opioid-sparing analgesic in patients with intractable cancer pain. There were expected and unexpected AEs of various grades with an encouraging initial impact on pain. (Funded by the Intramural Research Program of the National Institutes of Health Clinical Center and others; ClinicalTrials.gov number, NCT00804154).</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 6","pages":"EVIDoa2400423"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144152945","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Computer Decision Support May Facilitate Liberation from Mechanical Ventilation.","authors":"Yu Inata, Muneyuki Takeuchi","doi":"10.1056/EVIDe2500082","DOIUrl":"https://doi.org/10.1056/EVIDe2500082","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 6","pages":"EVIDe2500082"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144152972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Randomized Trial of Lung and Diaphragm Protective Ventilation in Children.","authors":"Robinder G Khemani, Anoopindar Bhalla, Justin C Hotz, Margaret J Klein, Jeni Kwok, Kristen Kohler, Dinnel Bornstein, Daniel Chang, Anabel Armenta-Quiroz, Kennedy Vu, Erin Smith, Anil Suresh, David Baron, Jennifer Bonilla-Cartagena, Patrick A Ross, Timothy Deakers, Fernando Beltramo, Lara Nelson, Shilpa Shah, Marsha Elkunovich, Martha A Q Curley, Wendy Mack, Christopher J L Newth","doi":"10.1056/EVIDoa2400360","DOIUrl":"10.1056/EVIDoa2400360","url":null,"abstract":"<p><strong>Background: </strong>Mechanical ventilation strategies that balance lung and diaphragm protection have not been extensively tested in clinical trials.</p><p><strong>Methods: </strong>We conducted a single-center, phase II randomized controlled trial in children with acute respiratory distress syndrome with two time points of random assignment: the acute and weaning phases of ventilation. Patients in the intervention group were managed with a computerized decision support (CDS) tool, named REDvent, and esophageal manometry to deliver lung and diaphragm protective ventilation. The control group received usual care. A daily standardized spontaneous breathing trial (SBT) was performed in both groups. The primary outcome was the length of weaning.</p><p><strong>Results: </strong>From October 2017 through March 2024, 248 children were randomly assigned to the acute phase. When participants were triggering the ventilator, the adjusted mean difference (REDvent-acute - usual care-acute) for peak inspiratory pressure was -3 cmH₂O (95% CI, -5 to -2), positive end-expiratory pressure was -2 cmH₂O (95% CI, -2 to -1), and the esophageal pressure swing was -1.8 cmH₂O (95% CI, -3.2 to -0.3). For the primary outcome, 55% of REDvent-acute patients passed their SBT or were extubated on the day of the first SBT, compared with 39% in the usual care-acute group. After adjusting for age, immunosuppression, and oxygenation index value, the REDvent-acute intervention resulted in a 1.67 (95% CI, 1.01 to 2.77; P=0.045) odds of a shorter length of weaning than usual care. The median time from intubation to SBT passage was 3.83 days in the intervention group versus 4.75 days in the usual care group. The length of ventilation among survivors was 5.0 days in the intervention group versus 5.6 days in the usual care group. When comparing weaning phase random assignment, clinical outcomes were similar between groups. There were no differences in adverse events between the groups.</p><p><strong>Conclusions: </strong>A lung and diaphragm protective ventilation strategy using a CDS tool during the acute phase of ventilation resulted in a shorter length of weaning than usual care. Phase III trials in mechanically ventilated patients are warranted. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT03266016.).</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 6","pages":"EVIDoa2400360"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144152979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reading and Interpreting Quality-of-Life Results in Cancer Trials.","authors":"Massimo Di Maio","doi":"10.1056/EVIDra2400340","DOIUrl":"https://doi.org/10.1056/EVIDra2400340","url":null,"abstract":"<p><p>AbstractThere is growing attention paid to patient-reported outcomes and health-related quality of life as end points in clinical trials in oncology. Such results should contribute to the definition of treatment value, inform communication with patients in clinical practice, and impact treatment choice among various options. This review seeks to help clinicians gain familiarity with the correct reading and interpretation of quality-of-life results.</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 6","pages":"EVIDra2400340"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144152980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Digital Care Plan Nudge to Improve Primary Care Outcomes.","authors":"Mitesh S Patel, Thomas A Aloia, Aaron G Shoemaker, Mohamad G Fakih, Frederick A Masoudi, Luke Smith, Emily Rosenzweig, Krisda H Chaiyachati, Benjamin N Conrad, Jeevan Bandreddi, Richard I Fogel","doi":"10.1056/EVIDoa2400419","DOIUrl":"10.1056/EVIDoa2400419","url":null,"abstract":"<p><strong>Background: </strong>Preventive care is underutilized in the United States. A digital care plan nudge delivered prior to primary care visits may prime patients to address these care gaps during the visit.</p><p><strong>Methods: </strong>A two-group, cluster randomized trial of 76 primary care practices in four U.S. states compared usual care with a digital care plan nudge, which sent text messages to patients before a primary care visit informing them of up to three of six possible care gaps to address at the visit. Outcomes were care gaps addressed the day of the visit (primary) and completed by 90 days after the visit (secondary). We also explored appointment engagement and patient experience.</p><p><strong>Results: </strong>The sample included 204 clinicians with 29,334 patient encounters. The mean (standard deviation) patient age was 56.9 (16.5) years, 61.0% were female, and 15.2% and 11.1% were Black and non-Hispanic or Hispanic, respectively. The primary outcome of care gaps addressed at the visit occurred in 23.5% of cases in the intervention group, compared with 20.3% of cases in the usual care group (adjusted difference 3.8 percentage points; 95% confidence interval (CI), -0.4 to 8.1; P=0.08). The intervention was associated with greater care gaps completed by 90 days (5.4 percentage points; 95% CI, 0.7 to 10.1). In post hoc analyses, the intervention was also associated with greater appointment engagement with an increase in completion (difference of 2.8 percentage points; 95% CI, 1.8 to 3.8), a decrease in no-shows (-1.2 percentage points; 95% CI, -1.7 to -0.6) and a decrease in cancellations (-1.5 percentage points; 95% CI, -2.2 to -0.8).</p><p><strong>Conclusions: </strong>This trial of a digital care plan nudge did not meet the primary outcome of addressing care gaps during the visit. Observed associations in secondary outcomes, including care gap closure within 90 days and appointment engagement, warrant further evaluation. (Funded by Ascension; ClinicalTrials.gov number, NCT05799976.).</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 6","pages":"EVIDoa2400419"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144152967","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}