{"title":"Interstate Telemedicine in the Courtroom.","authors":"Charles G Kels","doi":"10.1001/jama.2024.24177","DOIUrl":"https://doi.org/10.1001/jama.2024.24177","url":null,"abstract":"","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":""},"PeriodicalIF":63.1,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142959130","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"\"I wuz here\": Training the Eye in Poetry and Medicine.","authors":"Rafael Campo","doi":"10.1001/jama.2024.19046","DOIUrl":"https://doi.org/10.1001/jama.2024.19046","url":null,"abstract":"","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":""},"PeriodicalIF":63.1,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142959115","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Audio Highlights: December 7-13, 2024.","authors":"","doi":"10.1001/jama.2023.18479","DOIUrl":"https://doi.org/10.1001/jama.2023.18479","url":null,"abstract":"","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":"333 1","pages":"e2318479"},"PeriodicalIF":63.1,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142959146","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sarah A Abramowitz, Kristin Boulier, Karl Keat, Katie M Cardone, Manu Shivakumar, John DePaolo, Renae Judy, Francisca Bermudez, Nour Mimouni, Christopher Neylan, Dokyoon Kim, Daniel J Rader, Marylyn D Ritchie, Benjamin F Voight, Bogdan Pasaniuc, Michael G Levin, Scott M Damrauer
Importance: Polygenic risk scores (PRSs) for coronary heart disease (CHD) are a growing clinical and commercial reality. Whether existing scores provide similar individual-level assessments of disease susceptibility remains incompletely characterized.
Objective: To characterize the individual-level agreement of CHD PRSs that perform similarly at the population level.
Design, setting, and participants: Cross-sectional study of participants from diverse backgrounds enrolled in the All of Us Research Program (AOU), Penn Medicine BioBank (PMBB), and University of California, Los Angeles (UCLA) ATLAS Precision Health Biobank with electronic health record and genotyping data.
Exposures: Polygenic risk for CHD from published PRSs and new PRSs developed separately from testing samples.
Main outcomes and measures: PRSs that performed population-level prediction similarly were identified by comparing calibration and discrimination of models of prevalent CHD. Individual-level agreement was tested with intraclass correlation coefficient (ICC) and Light κ.
Results: A total of 48 PRSs were calculated for 171 095 AOU participants. The mean (SD) age was 56.4 (16.8) years. A total of 104 947 participants (61.3%) were female. A total of 35 590 participants (20.8%) were most genetically similar to an African reference population, 29 801 (17.4%) to an admixed American reference population, 100 493 (58.7%) to a European reference population, and the remaining to Central/South Asian, East Asian, and Middle Eastern reference populations. There were 17 589 participants (10.3%) with and 153 506 participants without (89.7%) CHD. When included in a model of prevalent CHD, 46 scores had practically equivalent Brier scores and area under the receiver operator curves (region of practical equivalence ±0.02). Twenty percent of participants had at least 1 score in both the top and bottom 5% of risk. Continuous agreement of individual predictions was poor (ICC, 0.373 [95% CI, 0.372-0.375]). Light κ, used to evaluate consistency of risk assignment, did not exceed 0.56. Analysis among 41 193 PMBB and 53 092 ATLAS participants yielded different sets of equivalent scores, which also lacked individual-level agreement.
Conclusions and relevance: CHD PRSs that performed similarly at the population level demonstrated highly variable individual-level estimates of risk. Recognizing that CHD PRSs may generate incongruent individual-level risk estimates, effective clinical implementation will require refined statistical methods to quantify uncertainty and new strategies to communicate this uncertainty to patients and clinicians.
{"title":"Evaluating Performance and Agreement of Coronary Heart Disease Polygenic Risk Scores.","authors":"Sarah A Abramowitz, Kristin Boulier, Karl Keat, Katie M Cardone, Manu Shivakumar, John DePaolo, Renae Judy, Francisca Bermudez, Nour Mimouni, Christopher Neylan, Dokyoon Kim, Daniel J Rader, Marylyn D Ritchie, Benjamin F Voight, Bogdan Pasaniuc, Michael G Levin, Scott M Damrauer","doi":"10.1001/jama.2024.23784","DOIUrl":"10.1001/jama.2024.23784","url":null,"abstract":"<p><strong>Importance: </strong>Polygenic risk scores (PRSs) for coronary heart disease (CHD) are a growing clinical and commercial reality. Whether existing scores provide similar individual-level assessments of disease susceptibility remains incompletely characterized.</p><p><strong>Objective: </strong>To characterize the individual-level agreement of CHD PRSs that perform similarly at the population level.</p><p><strong>Design, setting, and participants: </strong>Cross-sectional study of participants from diverse backgrounds enrolled in the All of Us Research Program (AOU), Penn Medicine BioBank (PMBB), and University of California, Los Angeles (UCLA) ATLAS Precision Health Biobank with electronic health record and genotyping data.</p><p><strong>Exposures: </strong>Polygenic risk for CHD from published PRSs and new PRSs developed separately from testing samples.</p><p><strong>Main outcomes and measures: </strong>PRSs that performed population-level prediction similarly were identified by comparing calibration and discrimination of models of prevalent CHD. Individual-level agreement was tested with intraclass correlation coefficient (ICC) and Light κ.</p><p><strong>Results: </strong>A total of 48 PRSs were calculated for 171 095 AOU participants. The mean (SD) age was 56.4 (16.8) years. A total of 104 947 participants (61.3%) were female. A total of 35 590 participants (20.8%) were most genetically similar to an African reference population, 29 801 (17.4%) to an admixed American reference population, 100 493 (58.7%) to a European reference population, and the remaining to Central/South Asian, East Asian, and Middle Eastern reference populations. There were 17 589 participants (10.3%) with and 153 506 participants without (89.7%) CHD. When included in a model of prevalent CHD, 46 scores had practically equivalent Brier scores and area under the receiver operator curves (region of practical equivalence ±0.02). Twenty percent of participants had at least 1 score in both the top and bottom 5% of risk. Continuous agreement of individual predictions was poor (ICC, 0.373 [95% CI, 0.372-0.375]). Light κ, used to evaluate consistency of risk assignment, did not exceed 0.56. Analysis among 41 193 PMBB and 53 092 ATLAS participants yielded different sets of equivalent scores, which also lacked individual-level agreement.</p><p><strong>Conclusions and relevance: </strong>CHD PRSs that performed similarly at the population level demonstrated highly variable individual-level estimates of risk. Recognizing that CHD PRSs may generate incongruent individual-level risk estimates, effective clinical implementation will require refined statistical methods to quantify uncertainty and new strategies to communicate this uncertainty to patients and clinicians.</p>","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":"60-70"},"PeriodicalIF":63.1,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11569413/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142645224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"JAMA.","authors":"","doi":"10.1001/jama.2024.18695","DOIUrl":"https://doi.org/10.1001/jama.2024.18695","url":null,"abstract":"","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":"333 1","pages":"5-6"},"PeriodicalIF":63.1,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142959148","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mihai G Netea, Frank L van de Veerdonk, Evangelos J Giamarellos-Bourboulis
{"title":"Host-Directed Therapy in Pandemic Preparedness.","authors":"Mihai G Netea, Frank L van de Veerdonk, Evangelos J Giamarellos-Bourboulis","doi":"10.1001/jama.2024.26152","DOIUrl":"https://doi.org/10.1001/jama.2024.26152","url":null,"abstract":"","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":""},"PeriodicalIF":63.1,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142932809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Oral Antibiotics and Cutaneous Adverse Drug Reactions.","authors":"Grzegorz Porebski","doi":"10.1001/jama.2024.23974","DOIUrl":"https://doi.org/10.1001/jama.2024.23974","url":null,"abstract":"","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":""},"PeriodicalIF":63.1,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142932979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"For Gestational Diabetes Pharmacotherapy, Insulin Reigns Supreme.","authors":"Camille E Powe","doi":"10.1001/jama.2024.27148","DOIUrl":"https://doi.org/10.1001/jama.2024.27148","url":null,"abstract":"","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":""},"PeriodicalIF":63.1,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142932531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Doortje Rademaker, Leon de Wit, Ruben G Duijnhoven, Daphne N Voormolen, Ben Willem Mol, Arie Franx, J Hans DeVries, Rebecca C Painter, Bas B van Rijn, Sarah E Siegelaar, Bettina M C Akerboom, Rosalie M Kiewiet-Kemper, Marion A L Verwij-Didden, Fahima Assouiki, Simone M Kuppens, Mirjam M Oosterwerff, Eva Stekkinger, Mattheus J M Diekman, Tatjana E Vogelvang, Gerdien Belle-van Meerkerk, Sander Galjaard, Koen Verdonk, Annemiek Lub, Tamira K Klooker, Ineke Krabbendam, Jeroen P H van Wijk, Anjoke J M Huisjes, Thomas van Bemmel, Remco G W Nijman, Annewieke W van den Beld, Wietske Hermes, Solrun Johannsson-Vidarsdottir, Anneke G Vlug, Remke C Dullemond, Henrique J Jansen, Marieke Sueters, Eelco J P de Koning, Judith O E H van Laar, Pleun Wouters-van Poppel, Inge M Evers, Marina E Sanson-van Praag, Eline S van den Akker, Catherine B Brouwer, Brenda B Hermsen, Ralph Scholten, Rick I Meijer, Marsha van Leeuwen, Johanna A M Wijbenga, Lia D E Wijnberger, Arianne C van Bon, Flip W van der Made, Silvia A Eskes, Mirjam Zandstra, William H van Houtum, Babette A M Braams-Lisman, Catharina R G M Daemen-Gubbels, Janna W Nijkamp, Harold W de Valk, Maurice G A J Wouters, Richard G IJzerman, Irwin Reiss, Joris A M van der Post, Judith E Bosmans
<p><strong>Importance: </strong>Metformin and glyburide monotherapy are used as alternatives to insulin in managing gestational diabetes. Whether a sequential strategy of these oral agents results in noninferior perinatal outcomes compared with insulin alone is unknown.</p><p><strong>Objective: </strong>To test whether a treatment strategy of oral glucose-lowering agents is noninferior to insulin for prevention of large-for-gestational-age infants.</p><p><strong>Design, setting, and participants: </strong>Randomized, open-label noninferiority trial conducted at 25 Dutch centers from June 2016 to November 2022 with follow-up completed in May 2023. The study enrolled 820 individuals with gestational diabetes and singleton pregnancies between 16 and 34 weeks of gestation who had insufficient glycemic control after 2 weeks of dietary changes (defined as fasting glucose >95 mg/dL [>5.3 mmol/L], 1-hour postprandial glucose >140 mg/dL [>7.8 mmol/L], or 2-hour postprandial glucose >120 mg/dL [>6.7 mmol/L], measured by capillary glucose self-testing).</p><p><strong>Interventions: </strong>Participants were randomly assigned to receive metformin (initiated at a dose of 500 mg once daily and increased every 3 days to 1000 mg twice daily or highest level tolerated; n = 409) or insulin (prescribed according to local practice; n = 411). Glyburide was added to metformin, and then insulin substituted for glyburide, if needed, to achieve glucose targets.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was the between-group difference in the percentage of infants born large for gestational age (birth weight >90th percentile based on gestational age and sex). Secondary outcomes included maternal hypoglycemia, cesarean delivery, pregnancy-induced hypertension, preeclampsia, maternal weight gain, preterm delivery, birth injury, neonatal hypoglycemia, neonatal hyperbilirubinemia, and neonatal intensive care unit admission.</p><p><strong>Results: </strong>Among 820 participants, the mean age was 33.2 (SD, 4.7) years). In participants randomized to oral agents, 79% (n = 320) maintained glycemic control without insulin. With oral agents, 23.9% of infants (n = 97) were large for gestational age vs 19.9% (n = 79) with insulin (absolute risk difference, 4.0%; 95% CI, -1.7% to 9.8%; P = .09 for noninferiority), with the confidence interval of the risk difference exceeding the absolute noninferiority margin of 8%. Maternal hypoglycemia was reported in 20.9% with oral glucose-lowering agents and 10.9% with insulin (absolute risk difference, 10.0%; 95% CI, 3.7%-21.2%). All other secondary outcomes did not differ between groups.</p><p><strong>Conclusions and relevance: </strong>Treatment of gestational diabetes with metformin and additional glyburide, if needed, did not meet criteria for noninferiority compared with insulin with respect to the proportion of infants born large for gestational age.</p><p><strong>Trial registration: </strong>Netherlands Trial
{"title":"Oral Glucose-Lowering Agents vs Insulin for Gestational Diabetes: A Randomized Clinical Trial.","authors":"Doortje Rademaker, Leon de Wit, Ruben G Duijnhoven, Daphne N Voormolen, Ben Willem Mol, Arie Franx, J Hans DeVries, Rebecca C Painter, Bas B van Rijn, Sarah E Siegelaar, Bettina M C Akerboom, Rosalie M Kiewiet-Kemper, Marion A L Verwij-Didden, Fahima Assouiki, Simone M Kuppens, Mirjam M Oosterwerff, Eva Stekkinger, Mattheus J M Diekman, Tatjana E Vogelvang, Gerdien Belle-van Meerkerk, Sander Galjaard, Koen Verdonk, Annemiek Lub, Tamira K Klooker, Ineke Krabbendam, Jeroen P H van Wijk, Anjoke J M Huisjes, Thomas van Bemmel, Remco G W Nijman, Annewieke W van den Beld, Wietske Hermes, Solrun Johannsson-Vidarsdottir, Anneke G Vlug, Remke C Dullemond, Henrique J Jansen, Marieke Sueters, Eelco J P de Koning, Judith O E H van Laar, Pleun Wouters-van Poppel, Inge M Evers, Marina E Sanson-van Praag, Eline S van den Akker, Catherine B Brouwer, Brenda B Hermsen, Ralph Scholten, Rick I Meijer, Marsha van Leeuwen, Johanna A M Wijbenga, Lia D E Wijnberger, Arianne C van Bon, Flip W van der Made, Silvia A Eskes, Mirjam Zandstra, William H van Houtum, Babette A M Braams-Lisman, Catharina R G M Daemen-Gubbels, Janna W Nijkamp, Harold W de Valk, Maurice G A J Wouters, Richard G IJzerman, Irwin Reiss, Joris A M van der Post, Judith E Bosmans","doi":"10.1001/jama.2024.23410","DOIUrl":"https://doi.org/10.1001/jama.2024.23410","url":null,"abstract":"<p><strong>Importance: </strong>Metformin and glyburide monotherapy are used as alternatives to insulin in managing gestational diabetes. Whether a sequential strategy of these oral agents results in noninferior perinatal outcomes compared with insulin alone is unknown.</p><p><strong>Objective: </strong>To test whether a treatment strategy of oral glucose-lowering agents is noninferior to insulin for prevention of large-for-gestational-age infants.</p><p><strong>Design, setting, and participants: </strong>Randomized, open-label noninferiority trial conducted at 25 Dutch centers from June 2016 to November 2022 with follow-up completed in May 2023. The study enrolled 820 individuals with gestational diabetes and singleton pregnancies between 16 and 34 weeks of gestation who had insufficient glycemic control after 2 weeks of dietary changes (defined as fasting glucose >95 mg/dL [>5.3 mmol/L], 1-hour postprandial glucose >140 mg/dL [>7.8 mmol/L], or 2-hour postprandial glucose >120 mg/dL [>6.7 mmol/L], measured by capillary glucose self-testing).</p><p><strong>Interventions: </strong>Participants were randomly assigned to receive metformin (initiated at a dose of 500 mg once daily and increased every 3 days to 1000 mg twice daily or highest level tolerated; n = 409) or insulin (prescribed according to local practice; n = 411). Glyburide was added to metformin, and then insulin substituted for glyburide, if needed, to achieve glucose targets.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was the between-group difference in the percentage of infants born large for gestational age (birth weight >90th percentile based on gestational age and sex). Secondary outcomes included maternal hypoglycemia, cesarean delivery, pregnancy-induced hypertension, preeclampsia, maternal weight gain, preterm delivery, birth injury, neonatal hypoglycemia, neonatal hyperbilirubinemia, and neonatal intensive care unit admission.</p><p><strong>Results: </strong>Among 820 participants, the mean age was 33.2 (SD, 4.7) years). In participants randomized to oral agents, 79% (n = 320) maintained glycemic control without insulin. With oral agents, 23.9% of infants (n = 97) were large for gestational age vs 19.9% (n = 79) with insulin (absolute risk difference, 4.0%; 95% CI, -1.7% to 9.8%; P = .09 for noninferiority), with the confidence interval of the risk difference exceeding the absolute noninferiority margin of 8%. Maternal hypoglycemia was reported in 20.9% with oral glucose-lowering agents and 10.9% with insulin (absolute risk difference, 10.0%; 95% CI, 3.7%-21.2%). All other secondary outcomes did not differ between groups.</p><p><strong>Conclusions and relevance: </strong>Treatment of gestational diabetes with metformin and additional glyburide, if needed, did not meet criteria for noninferiority compared with insulin with respect to the proportion of infants born large for gestational age.</p><p><strong>Trial registration: </strong>Netherlands Trial","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":""},"PeriodicalIF":63.1,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142933317","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Oral Antibiotics and Cutaneous Adverse Drug Reactions-Reply.","authors":"Erika Y Lee, David N Juurlink","doi":"10.1001/jama.2024.23977","DOIUrl":"https://doi.org/10.1001/jama.2024.23977","url":null,"abstract":"","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":""},"PeriodicalIF":63.1,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142933313","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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