Journal of the American Medical Association最新文献

{"title":"Intravenous Lidocaine for Gut Function Recovery in Colonic Surgery: A Randomized Clinical Trial.","authors":"Hugh Paterson, Thenmalar Vadiveloo, Karen Innes, Angie Balfour, Marek Atter, Andrew Stoddart, Seonaidh Cotton, Robert Arnott, Lorna Aucott, Zoe Batham, Irwin Foo, Graeme MacLennan, Susan Nimmo, Doug Speake, John Norrie","doi":"10.1001/jama.2024.23898","DOIUrl":"10.1001/jama.2024.23898","url":null,"abstract":"<p><strong>Importance: </strong>Despite the recovery advantages of minimally invasive surgical techniques, delayed return of gut function after colectomy is a common barrier to timely discharge from hospital.</p><p><strong>Objective: </strong>To evaluate the effect of 2% perioperative intravenous lidocaine infusion on return of gut function after elective minimally invasive colon resection.</p><p><strong>Design, setting, and participants: </strong>The ALLEGRO trial was a randomized, placebo-controlled, double-blind trial conducted in 27 UK hospitals. A total of 590 adults scheduled for elective minimally invasive colon resection for benign or malignant disease were randomized 1:1 to 2% intravenous lidocaine or saline placebo. Enrollment occurred from August 13, 2018, to April 11, 2023, with a pause in recruitment from March 20, 2020, through July 6, 2020; final follow-up was on August 10, 2023.</p><p><strong>Interventions: </strong>The intervention patients received 2% intravenous lidocaine administered as 1.5-mg/kg bolus at induction of anesthesia followed by 1.5 mg/kg/h for 6 or 12 hours. Control patients received 0.9% saline placebo for 6 or 12 hours.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was the proportion of patients with return of gut function at 72 hours after surgery, defined by the GI-3 composite end point of tolerating diet (ingestion of food and drink without significant nausea or vomiting for 3 consecutive meals) and passage of flatus or stool. There were 11 secondary outcomes, including time to GI-3 recovery, time to GI-2 recovery (tolerance of oral diet and passage of stool), prolonged postoperative ileus, postoperative nausea and vomiting score, Overall Benefit of Analgesia Score, postoperative opioid consumption, Quality of Recovery-15, quality of life (EuroQol 5-Dimension 5-Level), enhanced recovery protocol adherence, time to meeting medically defined criteria for discharge, and time to patient self-assessed readiness for discharge.</p><p><strong>Results: </strong>The trial enrolled 590 patients (295 intervention, 295 control); after 33 postrandomization exclusions, 557 patients were included (279 intervention, 278 control; 249 female patients [44.7%]; mean [SD] age, 66 [10.9] years); 532 (96%) received the randomized treatment. Return of gut function as defined by the GI-3 composite outcome was achieved at 72 hours by 160 patients (57.3%) in the intravenous lidocaine group vs 164 patients (59.0%) in the placebo group (adjusted absolute difference, -1.9% [95% CI, -8.0% to 4.2%]; relative risk, 0.97 [95% CI, 0.88 to 1.07]). There was no significant difference between the intervention and control groups in any of the 11 secondary end points.</p><p><strong>Conclusions and relevance: </strong>Among patients undergoing elective minimally invasive colon resection, perioperative administration of 2% intravenous lidocaine did not improve return of gut function at 72 hours.</p><p><strong>Trial registratio","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"39-48"},"PeriodicalIF":0.0,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11603374/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142739567","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Postmarketing Surveillance of Inferior Vena Cava Filters Among US Medicare Beneficiaries: The SAFE-IVC Study.","authors":"Enrico G Ferro, Julie B Mackel, Renee D Kramer, Rebecca Torguson, Eleni M Whatley, Gregory O'Connell, Brian Pullin, Nathan W Watson, Siling Li, Yang Song, Anna K Krawisz, Brett J Carroll, Marc L Schermerhorn, Jeffrey L Weinstein, Andrew Farb, Bram Zuckerman, Robert W Yeh, Eric A Secemsky","doi":"10.1001/jama.2024.19553","DOIUrl":"10.1001/jama.2024.19553","url":null,"abstract":"<p><strong>Importance: </strong>Inferior vena cava filters (IVCFs) are commonly used to prevent pulmonary embolism in selected clinical scenarios, despite limited evidence to support their use. Current recommendations from professional societies and the US Food and Drug Administration endorse timely IVCF retrieval when clinically feasible. Current IVCF treatment patterns and outcomes remain poorly described.</p><p><strong>Objectives: </strong>To evaluate temporal trends and practice patterns in IVCF insertion and retrieval among older US patients and report the incidence of periprocedural and long-term safety events of indwelling and retrieved IVCFs.</p><p><strong>Design, setting, and participants: </strong>Prespecified, retrospective, observational cohort of Medicare Fee-for-Service (FFS) beneficiaries, leveraging 100% of samples of inpatient and outpatient claims data from January 1, 2013, to December 31, 2021.</p><p><strong>Exposure: </strong>First-time IVCF insertion while insured by Medicare FFS.</p><p><strong>Main outcomes and measures: </strong>The primary safety outcome was the composite of all-cause death, filter-related complications (eg, fracture, embolization), operating room visits following filter-related procedures, or new diagnosis of deep vein thrombosis (DVT). Events were considered periprocedural if they occurred within 30 days of IVCF insertion or retrieval and long-term if they occurred more than 30 days after.</p><p><strong>Results: </strong>Among 270 866 patients with IVCFs placed during the study period (mean age, 75.1 years; 52.8% female), 64.9% were inserted for first-time venous thromboembolism (VTE), 26.3% for recurrent VTE, and 8.8% for VTE prophylaxis. Of these patients, 63.3% had major bleeds or trauma within 30 days of IVCF insertion. The volume of insertions decreased from 44 680 per year in 2013 to 19 501 per year in 2021. The cumulative incidence of retrieval was 15.3% at a median of 1.2 years and 16.8% at maximum follow-up of 9.0 years. Older age, more comorbidities, and Black race were associated with a decreased likelihood of retrieval, whereas placement at a large teaching hospital was associated with an increased likelihood of retrieval. The incidence of caval thrombosis and DVT among patients with nonretrieved IVCFs was 2.2% (95% CI, 2.1%-2.3%) and 9.2% (95% CI, 9.0%-9.3%), respectively. The majority (93.5%) of retrieval attempts were successful, with low incidence of 30-day complications (mortality, 0.7% [95% CI, 0.6%-0.8%]; filter-related complications, 1.4% [95% CI, 1.2%-1.5%]).</p><p><strong>Conclusions and relevance: </strong>In this large, US real-world analysis, IVCF insertion declined, yet retrievals remained low. Strategies to increase timely retrieval are needed, as nonretrieved IVCFs may have long-term complications.</p>","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"2091-2100"},"PeriodicalIF":0.0,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11541742/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583460","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Differential Legal Protections for Biologics vs Small-Molecule Drugs in the US.","authors":"Olivier J Wouters, Matthew Vogel, William B Feldman, Reed F Beall, Aaron S Kesselheim, S Sean Tu","doi":"10.1001/jama.2024.16911","DOIUrl":"10.1001/jama.2024.16911","url":null,"abstract":"<p><strong>Importance: </strong>Biologics approved by the US Food and Drug Administration (FDA) receive 12 years of guaranteed protection from biosimilar competition compared with 5 years of protection from generic competition for new small-molecule drugs. Under the 2022 Inflation Reduction Act, biologics are exempt from selection for Medicare price negotiation for 11 years compared with 7 years for small-molecule drugs. Congress codified these differing legal protections on the premise that biologics require more time and resources to develop and have weaker patent protection, necessitating additional protections for manufacturers to recoup their development costs and generate adequate returns on investment.</p><p><strong>Objective: </strong>To review empirical evidence from the US experience with biologics to analyze the assumptions underlying longer periods of market exclusivity and protection from price negotiation compared with small-molecule drugs.</p><p><strong>Evidence review: </strong>Recent data on development times, clinical trial success rates, research and development costs, patent protection, market exclusivity periods, revenues, and treatment costs of biologics vs small-molecule drugs were analyzed.</p><p><strong>Findings: </strong>The FDA approved 599 new therapeutic agents from 2009-2023, of which 159 (27%) were biologics and 440 (73%) were small-molecule drugs. Median development times were 12.6 years (IQR, 10.6-15.3 years) for biologics vs 12.7 years (IQR, 10.2-15.5 years) for small-molecule drugs (P = .76). Biologics had higher clinical trial success rates at every phase of development. Median development costs were estimated to be $3.0 billion (IQR, $1.3 billion-$5.5 billion) for biologics and $2.1 billion (IQR, $1.3 billion-$3.7 billion) for small-molecule drugs (P = .39). Biologics were protected by a median of 14 patents (IQR, 5-24 patents) compared with 3 patents (IQR, 2-5 patents) for small-molecule drugs (P < .001). The median time to biosimilar competition was 20.3 years (IQR, 16.9-21.7 years) compared with 12.6 years (IQR, 12.5-13.5 years) for small-molecule drugs. Biologics achieved higher median peak revenues ($1.1 billion in year 13; IQR, $0.5 billion-$2.9 billion) than small-molecule drugs ($0.5 billion in year 8; IQR, $0.1 billion-$1.2 billion; P = .01) and had higher median revenues in each year following FDA approval. The median annual cost of treatment was $92 000 (IQR, $31 000-$357 000) for biologics and $33 000 (IQR, $4000-$177 000) for small-molecule drugs (P = .005).</p><p><strong>Conclusions and relevance: </strong>There is little evidence to support biologics having longer periods of market exclusivity or protection from negotiation. As a result of differential treatment, US law appears to overly reward the development of biologics relative to small-molecule drugs.</p>","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"2101-2108"},"PeriodicalIF":0.0,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142710501","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":"The Tobacco Industry Has No Business Funding Continuing Medical Education.","authors":"Robert K Jackler, Pamela M Ling","doi":"10.1001/jama.2024.9241","DOIUrl":"10.1001/jama.2024.9241","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"2059-2060"},"PeriodicalIF":0.0,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141555117","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":"Online Retailer Nonadherence to Age Verification, Shipping, and Flavor Restrictions on E-Cigarettes.","authors":"Raquel M Harati, Shannon E Ellis, Nora Satybaldiyeva, Tomas Mejorado, Gustavo Benitez, Lisa Henriksen, Eric C Leas","doi":"10.1001/jama.2024.21597","DOIUrl":"10.1001/jama.2024.21597","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"2113-2114"},"PeriodicalIF":0.0,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11555574/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142623096","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mental Health First Aid Advances Into the Workplace, but Questions Remain.","authors":"Anna Bock","doi":"10.1001/jama.2024.21272","DOIUrl":"10.1001/jama.2024.21272","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"2051-2052"},"PeriodicalIF":0.0,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638795","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":"Corrections for Conversion of Laboratory Values and Units of Activity Levels.","authors":"Zhongrong Miao","doi":"10.1001/jama.2024.24658","DOIUrl":"10.1001/jama.2024.24658","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"2118-2119"},"PeriodicalIF":0.0,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142739612","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 Health Behavior Intervention to Prevent Childhood Obesity: The Greenlight Plus Randomized Clinical Trial.","authors":"William J Heerman, Russell L Rothman, Lee M Sanders, Jonathan S Schildcrout, Kori B Flower, Alan M Delamater, Melissa C Kay, Charles T Wood, Rachel S Gross, Aihua Bian, Laura E Adams, Evan C Sommer, H Shonna Yin, Eliana M Perrin, Belen de la Barrera, Malakha Bility, Michelle Cruz Jimenez Smith, Evelyn F Cruzatte, Gabriela Guevara, Janna B Howard, Jacarra Lampkin, Colin J Orr, Jennifer Pilotos McBride, Lourdes Quintana Forster, Kimberly S Ramirez, Javier Rodriguez, Samantha Schilling, W Elizabeth Shepard, Altagracia Soto, Jessica J Velazquez, Shelby Wallace","doi":"10.1001/jama.2024.22362","DOIUrl":"10.1001/jama.2024.22362","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;Infant growth predicts long-term obesity and cardiovascular disease. Previous interventions designed to prevent obesity in the first 2 years of life have been largely unsuccessful. Obesity prevalence is high among traditional racial and ethnic minority groups.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To compare the effectiveness of adding a digital childhood obesity prevention intervention to health behavior counseling delivered by pediatric primary care clinicians.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;Individually randomized, parallel-group trial conducted at 6 US medical centers and enrolling patients shortly after birth. To be eligible, parents spoke English or Spanish, and children were born after 34 weeks' gestational age. Study enrollment occurred between October 2019 and January 2022, with follow-up through January 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interventions: &lt;/strong&gt;In the clinic-based health behavior counseling (clinic-only) group, pediatric clinicians used health literacy-informed booklets at well-child visits to promote healthy behaviors (n = 451). In the clinic + digital intervention group, families also received health literacy-informed, individually tailored, responsive text messages to support health behavior goals and a web-based dashboard (n = 449).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;The primary outcome was child weight-for-length trajectory over 24 months. Secondary outcomes included weight-for-length z score, body mass index (BMI) z score, and the percentage of children with overweight or obesity.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Of 900 randomized children, 86.3% had primary outcome data at the 24-month follow-up time point; 143 (15.9%) were Black, non-Hispanic; 405 (45.0%) were Hispanic; 185 (20.6%) were White, non-Hispanic; and 165 (18.3%) identified as other or multiple races and ethnicities. Children in the clinic + digital intervention group had a lower mean weight-for-length trajectory, with an estimated reduction of 0.33 kg/m (95% CI, 0.09 to 0.57) at 24 months. There was also an adjusted mean difference of -0.19 (95% CI, -0.37 to -0.02) for weight-for-length z score and -0.19 (95% CI, -0.36 to -0.01) for BMI z score. At age 24 months, 23.2% of the clinic + digital intervention group compared with 24.5% of the clinic-only group had overweight or obesity (adjusted risk ratio, 0.91 [95% CI, 0.70 to 1.17]) based on the Centers for Disease Control and Prevention criteria of BMI 85th percentile or greater. At that age, 7.4% of the clinic + digital intervention group compared with 12.7% of the clinic-only group had obesity (adjusted risk ratio, 0.56 [95% CI, 0.36 to 0.88]).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;A health literacy-informed digital intervention improved child weight-for-length trajectory across the first 24 months of life and reduced childhood obesity at 24 months. The intervention was effective in a racially and ethnically diverse population that in","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"2068-2080"},"PeriodicalIF":0.0,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11533126/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142569013","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Errors in Reported Laboratory Values.","authors":"","doi":"10.1001/jama.2024.24919","DOIUrl":"10.1001/jama.2024.24919","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"2119"},"PeriodicalIF":0.0,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11603375/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142739648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Endometriosis and Ovarian Cancer.","authors":"Kathryn L Terry, Holly R Harris, Stacey A Missmer","doi":"10.1001/jama.2024.21905","DOIUrl":"10.1001/jama.2024.21905","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"2116-2117"},"PeriodicalIF":0.0,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142770084","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}