PLoS Medicine最新文献

{"title":"Predicting patent challenges for small-molecule drugs: A cross-sectional study.","authors":"Ally Memedovich, Brian Steele, Taylor Orr, Shanzeh Chaudhry, Mina Tadrous, Aaron S Kesselheim, Aidan Hollis, Reed F Beall","doi":"10.1371/journal.pmed.1004540","DOIUrl":"10.1371/journal.pmed.1004540","url":null,"abstract":"<p><strong>Background: </strong>The high cost of prescription drugs in the United States is maintained by brand-name manufacturers' competition-free period made possible in part through patent protection, which generic competitors must challenge to enter the market early. Understanding the predictors of these challenges can inform policy development to encourage timely generic competition. Identifying categories of drugs systematically overlooked by challengers, such as those with low market size, highlights gaps where unchecked patent quality and high prices persist, and can help design policy interventions to help promote timely patient access to generic drugs including enhanced patent scrutiny or incentives for challenges. Our objective was to characterize and assess the extent to which market size and other drug characteristics can predict patent challenges for brand-name drugs.</p><p><strong>Methods and findings: </strong>This cross-sectional study included new patented small-molecule drugs approved by the FDA from 2007 to 2018. Market size, patent, and patent challenge data came from IQVIA MIDAS pharmaceutical quarterly sales data, the FDA's Orange Book database, and the FDA's Paragraph IV list. Predictive models were constructed using random forest and elastic net classification. The primary outcome was the occurrence of a patent challenge within the first year of eligibility. Of the 210 new small-molecule drugs included in the sample, 55% experienced initiation of patent challenge within the first year of eligibility. Market value was the most important predictor variable, with larger markets being more likely to be associated with patent challenges. Drugs in the anti-infective therapeutic class or those with fast-track approval were less likely to be challenged. The limitations of this work arise from the exclusion of variables that were not readily available publicly, will be the target of future research, or were deemed beyond the scope of this project.</p><p><strong>Conclusions: </strong>Generic competition does not occur with the same timeliness across all drug markets, which can leave granted patents of questionable merit in place and sustain high brand-name drug prices. Predictive models may help direct limited resources for post-grant patent validity review and adjust policy when generic competition is lacking.</p>","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 2","pages":"e1004540"},"PeriodicalIF":15.8,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11867330/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143411281","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":"Protecting mother and baby: Learnings from an Ebola vaccination campaign on the evolving landscape of vaccines and pregnancy.","authors":"Rebecca F Grais, Kathleen M Neuzil, Helen Rees, Cristiana M Toscano","doi":"10.1371/journal.pmed.1004530","DOIUrl":"10.1371/journal.pmed.1004530","url":null,"abstract":"<p><p>This Perspective article from Rebecca Grais and colleagues places a recently published study in PLOS Medicine in the context of the evolving landscape of vaccines and pregnancy.</p>","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 2","pages":"e1004530"},"PeriodicalIF":15.8,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11813148/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143400423","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":"Contraception use and pregnancy in women receiving a 2-dose Ebola vaccine in Rwanda: A retrospective analysis of UMURINZI vaccination campaign data.","authors":"Rosine Ingabire, Julien Nyombayire, Amelia Mazzei, Jean-Baptiste Mazarati, Jozef Noben, Michael Katwere, Rachel Parker, Sabin Nsanzimana, Kristin M Wall, Tyronza Sharkey, Felix Sayinzoga, Amanda Tichacek, Niina Hammoud, Ellen Martinson, Ben Magod, Susan Allen, Etienne Karita","doi":"10.1371/journal.pmed.1004508","DOIUrl":"10.1371/journal.pmed.1004508","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Rwandan individuals bordering the Democratic Republic of the Congo (DRC) are at-risk of Ebola virus disease. A 2019 to 2021 vaccination campaign called UMURINZI offered a Janssen Vaccines & Prevention B.V. 2-dose heterologous Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo) to Rwandan individuals aged ≥2 years and not pregnant. In this region with high rates of pregnancy, preventing pregnancy until their second dose of the Ebola vaccine is essential to ensure full protection. This analysis describes contraceptive use, pregnancy incidence, serious adverse events (SAE), and the effect of pregnancy and SAE on receipt of the second dose among women in the UMURINZI vaccination campaign.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods and findings: &lt;/strong&gt;During the vaccination campaign, women who were fertile and sexually active were counseled as part of the campaign by trained UMURINZI nursing staff about preventing pregnancy until dose two (56 days post-dose one) and offered contraception. Women were followed up to their second dose appointment. Contraception, pregnancy incidence, and SAE were recorded. Of the 47,585 fertile and sexually active women, the mean age was 28·0 years (standard deviation 9·9 years), 54·7% (n = 26,051) were from Rubavu and 45·3% (n = 21,534) were from Rusizi, and 71·9% (n = 34,158) had not crossed the DRC border in the last year. Sixty-six percent (66·6%, n = 31,675) were not using modern contraception at baseline and 19·1% (n = 9,082) were using hormonal implants, 10·9% (n = 5,204) injectables, 2·9% (n = 1,393) oral contraceptive pills (OCPs), and 0·5% (n = 231) intrauterine devices. After contraceptive counseling, 8·0% (n = 2,549) of non-users initiated a method of contraception and 3·6% (n = 50) of OCP users switched to a more effective method. Of the 969 incident pregnancies detected after dose one, 18·8% (n = 182) resulted in an obstetric SAE, primarily due to spontaneous abortion which occurred in 16·0% (n = 155) of all incident pregnancies. Other obstetric SAE included 14 blighted ova, 9 stillbirths, 1 termination due to hydrops fetalis, 1 cleft palate, and 2 threatened abortions resulting in normal deliveries. Six pregnant women had a non-obstetric SAE (0·6%), including 1 postpartum death from COVID-19 and 5 hospitalizations. Among the 74,002 women without an incident pregnancy detected after dose one, 0·01% (n = 4) had an SAE; 2 were fatalities due to hypertension and diabetes in one case and seizures in the other, and the other 2 were hospitalizations. No SAE were determined to be related to the vaccine by the program physicians. Among the 74,002 women without an incident pregnancy detected after dose one, 94·6% (n = 69,986) received dose two; in contrast, among the 969 women with an incident pregnancy detected after dose one, 34·5% (n = 334) received dose two after pregnancy completion.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Many fertile and sexually active women who sought vaccination during UMURINZI were n","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 2","pages":"e1004508"},"PeriodicalIF":15.8,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11813098/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143400421","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":"Potential public health impacts of gonorrhea vaccination programmes under declining incidences: A modeling study.","authors":"Lin Geng, Lilith K Whittles, Borame L Dickens, Martin T W Chio, Yihao Chen, Rayner Kay Jin Tan, Azra Ghani, Jue Tao Lim","doi":"10.1371/journal.pmed.1004521","DOIUrl":"10.1371/journal.pmed.1004521","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Gonorrhea is the second most common sexually transmitted disease notified in Singapore in 2023. Evidence suggests that the 4CMenB vaccine designed to protect against Neisseria meningitidis infection may offer partial cross-protection against gonorrhea. This generated interest in using 4CMenB for the purpose of staving gonorrhea transmission. We explored the efficacy of potential gonorrhea vaccination strategies in the context of historically declining gonorrhea incidence.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods and findings: &lt;/strong&gt;We employed an integrated transmission-dynamic model, calibrated using Bayesian methods to local surveillance data to understand the potential public health impact of 4CMenB in reducing gonorrhea acquisition and transmission in men who have sex with men (MSM) in Singapore. We explored the efficacy of implementing six vaccination programmes: (1) offering vaccination to all male adolescents in schools (vaccination before entry [VbE]), (2) offering vaccination to individuals attending sexual health clinics for testing (vaccination on attendance [VoA]), (3) offering vaccination to individuals attending sexual health clinics and who were diagnosed with gonorrhea (vaccination on diagnosis [VoD]), or (4) vaccination according to risk (VaR), by offering vaccination to patients who were diagnosed with gonorrhea plus individuals who tested negative, but report having more than five sexual partners per year. We further examined how altering (5) VoA and (6) VoD strategies changed if the strategies only targeted high risk groups (VoA(H),VoD(H)). We assessed efficacy by examining vaccination impact relative to no vaccination and when behavioral parameters were held constant. We further ascertained the effects of varying vaccine uptake (10%, 33%, 100%), vaccine efficacy (22%, 31%, 47%), and duration of protection (1.5, 4, 7.5 years) on the effectiveness of each vaccination strategy. For a hypothetical 10-year vaccination programme, VbE had 14.18% of MSM gonorrhea cases averted over the time the programme was implemented. VoA had the highest protective impact on the MSM population with 40.26% averted cases (95% credible interval (CrI): 18.32%-52.57%), but required more vaccine doses than any other strategy. VoD had a smaller impact (12.04% averted cases (95% CrI: 7.12%-15.00%)), but was three times more efficient than VoA in terms of averted cases per dose. VoA(H) and VoD(H) improved the efficiency of VoA and VoD strategies by increasing averted cases per dose to 0.22 and 0.24 respectively, but conferred similar protective effects as VoA (VoA(H): 40.10% averted cases (95% CrI: 18.14%-52.55%)) and VoD (VoD(H): 12.04% averted cases (95% CrI: 7.12%-15.00%)), respectively. VaR (40.10% averted cases (95% CrI: 18.14%-52.55%)) had almost the same impact as VoA, but was more efficient by requiring administration of fewer doses than VoA, with 0.21 (95% CrI: 0.12-0.27) averted cases per dose. Sensitivity analyses indicated that ","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 2","pages":"e1004521"},"PeriodicalIF":15.8,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11805383/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143371339","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":"Improving monitoring of sexual, reproductive health, and rights globally.","authors":"Sacha St-Onge Ahmad, Zulfiqar A Bhutta","doi":"10.1371/journal.pmed.1004525","DOIUrl":"10.1371/journal.pmed.1004525","url":null,"abstract":"","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 2","pages":"e1004525"},"PeriodicalIF":15.8,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11801524/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143366213","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":"Accuracy and clinical effectiveness of risk prediction tools for pressure injury occurrence: An umbrella review.","authors":"Bethany Hillier, Katie Scandrett, April Coombe, Tina Hernandez-Boussard, Ewout Steyerberg, Yemisi Takwoingi, Vladica M Veličković, Jacqueline Dinnes","doi":"10.1371/journal.pmed.1004518","DOIUrl":"10.1371/journal.pmed.1004518","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Pressure injuries (PIs) pose a substantial healthcare burden and incur significant costs worldwide. Several risk prediction tools to allow timely implementation of preventive measures and a subsequent reduction in healthcare system burden are available and in use. The ability of risk prediction tools to correctly identify those at high risk of PI (prognostic accuracy) and to have a clinically significant impact on patient management and outcomes (effectiveness) is not clear. We aimed to evaluate the prognostic accuracy and clinical effectiveness of risk prediction tools for PI and to identify gaps in the literature.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods and findings: &lt;/strong&gt;The umbrella review was conducted according to Cochrane guidance. Systematic reviews (SRs) evaluating the accuracy or clinical effectiveness of adult PI risk prediction tools in any clinical settings were eligible. Studies on paediatric tools, sensor-only tools, or staging/diagnosis of existing PIs were excluded. MEDLINE, Embase, CINAHL, and EPISTEMONIKOS were searched (inception to June 2024) to identify relevant SRs, as well as Google Scholar (2013 to 2024) and reference lists. Methodological quality was assessed using adapted AMSTAR-2 criteria. Results were described narratively. We identified 26 SRs meeting all eligibility criteria with 19 SRs assessing prognostic accuracy and 11 assessing clinical effectiveness of risk prediction tools for PI (4 SRs assessed both aspects). The 19 SRs of prognostic accuracy evaluated 70 tools (39 scales and 31 machine learning (ML) models), with the Braden, Norton, Waterlow, Cubbin-Jackson scales (and modifications thereof) the most evaluated tools. Meta-analyses from a focused set of included SRs showed that the scales had sensitivities and specificities ranging from 53% to 97% and 46% to 84%, respectively. Only 2/19 (11%) SRs performed appropriate statistical synthesis and quality assessment. Two SRs assessing machine learning-based algorithms reported high prognostic accuracy estimates, but some of which were sourced from the same data within which the models were developed, leading to potentially overoptimistic results. Two randomised trials assessing the effect of PI risk assessment tools (within the full test-intervention-outcome pathway) on the incidence of PIs were identified from the 11 SRs of clinical effectiveness; both were included in a Cochrane SR and assessed as high risk of bias. Both trials found no evidence of an effect on PI incidence. Limitations included the use of the AMSTAR-2 criteria, which may have overly focused on reporting quality rather than methodological quality, compounded by the poor reporting quality of included SRs and that SRs were not excluded based on low AMSTAR-2 ratings (in order to provide a comprehensive overview). Additionally, diagnostic test accuracy principles, rather than prognostic modelling approaches were heavily relied upon, which do not account for the temporal nature of","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 2","pages":"e1004518"},"PeriodicalIF":15.8,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11844857/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143366019","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":"Effects of X-ray-based diagnosis and explanation of knee osteoarthritis on patient beliefs about osteoarthritis management: A randomised clinical trial.","authors":"Belinda J Lawford, Kim L Bennell, Dan Ewald, Peixuan Li, Anurika De Silva, Jesse Pardo, Barbara Capewell, Michelle Hall, Travis Haber, Thorlene Egerton, Stephanie Filbay, Fiona Dobson, Rana S Hinman","doi":"10.1371/journal.pmed.1004537","DOIUrl":"10.1371/journal.pmed.1004537","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Although X-rays are not recommended for routine diagnosis of osteoarthritis (OA), clinicians and patients often use or expect X-rays. We evaluated whether: (i) a radiographic diagnosis and explanation of knee OA influences patient beliefs about management, compared to a clinical diagnosis and explanation that does not involve X-rays; and (ii) showing the patient their X-ray images when explaining radiographic report findings influences beliefs, compared to not showing X-ray images.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods and findings: &lt;/strong&gt;This was a 3-arm randomised controlled trial conducted between May 23, 2024 and May 28, 2024 as a single exposure (no follow-up) online survey. A total of 617 people aged ≥45 years, with and without chronic knee pain, were recruited from the Australian-wide community. Participants were presented with a hypothetical scenario where their knee was painful for 6 months and they had made an appointment with a general practitioner (primary care physician). Participants were randomly allocated to one of 3 groups where they watched a 2-min video of the general practitioner providing them with either: (i) clinical explanation of knee OA (no X-rays); (ii) radiographic explanation (not showing X-ray images); or (iii) radiographic explanation (showing X-ray images). Primary comparisons were: (i) clinical explanation (no X-rays) versus radiographic explanation (showing X-ray images); and (ii) radiographic explanation (not showing X-ray images) versus radiographic explanation (showing X-ray images). Primary outcomes were perceived (i) necessity of joint replacement surgery; and (ii) helpfulness of exercise and physical activity, both measured on 11-point numeric rating scales (NRS) ranging 0 to 10. Compared to clinical explanation (no X-rays), those who received radiographic explanation (showing X-ray images) believed surgery was more necessary (mean 3.3 [standard deviation: 2.7] versus 4.5 [2.7], respectively; mean difference 1.1 [Bonferroni-adjusted 95% confidence interval: 0.5, 1.8]), but there were no differences in beliefs about the helpfulness of exercise and physical activity (mean 7.9 [standard deviation: 1.9] versus 7.5 [2.2], respectively; mean difference -0.4 [Bonferroni-adjusted 95% confidence interval: -0.9, 0.1]). There were no differences in beliefs between radiographic explanation with and without showing X-ray images (for beliefs about necessity of surgery: mean 4.5 [standard deviation: 2.7] versus 3.9 [2.6], respectively; mean difference 0.5 [Bonferroni-adjusted 95% confidence interval: -0.1, 1.2]; for beliefs about helpfulness of exercise and physical activity: mean 7.5 [standard deviation: 2.2] versus 7.7 [2.0], respectively; mean difference -0.2 [Bonferroni-adjusted 95% confidence interval: -0.7, 0.3]). Limitations of our study included the fact that participants were responding to a hypothetical scenario, and so findings may not necessarily translate to real-world clinical situations, ","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 2","pages":"e1004537"},"PeriodicalIF":15.8,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11838874/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143191049","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":"Consecutive prediction of adverse maternal outcomes of preeclampsia, using the PIERS-ML and fullPIERS models: A multicountry prospective observational study.","authors":"Guiyou Yang, Tünde Montgomery-Csobán, Wessel Ganzevoort, Sanne J Gordijn, Kimberley Kavanagh, Paul Murray, Laura A Magee, Henk Groen, Peter von Dadelszen","doi":"10.1371/journal.pmed.1004509","DOIUrl":"10.1371/journal.pmed.1004509","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Preeclampsia is a potentially life-threatening pregnancy complication. Among women whose pregnancies are complicated by preeclampsia, the Preeclampsia Integrated Estimate of RiSk (PIERS) models (i.e., the PIERS Machine Learning [PIERS-ML] model, and the logistic regression-based fullPIERS model) accurately identify individuals at greatest or least risk of adverse maternal outcomes within 48 h following admission. Both models were developed and validated to be used as part of initial assessment. In the United Kingdom, the National Institute for Health and Care Excellence (NICE) recommends repeated use of such static models for ongoing assessment beyond the first 48 h. This study evaluated the models' performance during such consecutive prediction.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods and findings: &lt;/strong&gt;This multicountry prospective study used data of 8,843 women (32% white, 30% black, and 26% Asian) with a median age of 31 years. These women, admitted to maternity units in the Americas, sub-Saharan Africa, South Asia, Europe, and Oceania, were diagnosed with preeclampsia at a median gestational age of 35.79 weeks between year 2003 and 2016. The risk differentiation performance of the PIERS-ML and fullPIERS models were assessed for each day within a 2-week post-admission window. The PIERS adverse maternal outcome includes one or more of: death, end-organ complication (cardiorespiratory, renal, hepatic, etc.), or uteroplacental dysfunction (e.g., placental abruption). The main outcome measures were: trajectories of mean risk of each of the uncomplicated course and adverse outcome groups; daily area under the precision-recall curve (AUC-PRC); potential clinical impact (i.e., net benefit in decision curve analysis); dynamic shifts of multiple risk groups; and daily likelihood ratios. In the 2 weeks window, the number of daily outcome events decreased from over 200 to around 10. For both PIERS-ML and fullPIERS models, we observed consistently higher mean risk in the adverse outcome (versus uncomplicated course) group. The AUC-PRC values (0.2-0.4) of the fullPIERS model remained low (i.e., close to the daily fraction of adverse outcomes, indicating low discriminative capacity). The PIERS-ML model's AUC-PRC peaked on day 0 (0.65), and notably decreased thereafter. When categorizing women into multiple risk groups, the PIERS-ML model generally showed good rule-in capacity for the \"very high\" risk group, with positive likelihood ratio values ranging from 70.99 to infinity, and good rule-out capacity for the \"very low\" risk group where most negative likelihood ratio values were 0. However, performance declined notably for other risk groups beyond 48 h. Decision curve analysis revealed a diminishing advantage for treatment guided by both models over time. The main limitation of this study is that the baseline performance of the PIERS-ML model was assessed on its development data; however, its baseline performance has also undergone exter","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 2","pages":"e1004509"},"PeriodicalIF":15.8,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11793762/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143190873","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":"The effect of prenatal balanced energy and protein supplementation on gestational weight gain: An individual participant data meta-analysis in low- and middle-income countries.","authors":"Dongqing Wang, Uttara Partap, Enju Liu, Janaína Calu Costa, Ilana R Cliffer, Molin Wang, Sudeer Kumar Nookala, Vishak Subramoney, Brittany Briggs, Imran Ahmed, Alemayehu Argaw, Shabina Ariff, Nita Bhandari, Ranadip Chowdhury, Daniel Erchick, Armando García-Guerra, Masoumah Ghaffarpour, Giles Hanley-Cook, Lieven Huybregts, Fyezah Jehan, Fatemeh Kaseb, Nancy F Krebs, Carl Lachat, Tsering Pema Lama, Dharma S Manandhar, Elizabeth M McClure, Sophie E Moore, Ameer Muhammad, Lynnette M Neufeld, Andrew M Prentice, Amado D Quezada-Sánchez, Dominique Roberfroid, Naomi M Saville, Yasir Shafiq, Bhim P Shrestha, Bakary Sonko, Sajid Soofi, Sunita Taneja, James M Tielsch, Laéticia Céline Toe, Naser Valaei, Wafaie W Fawzi","doi":"10.1371/journal.pmed.1004523","DOIUrl":"10.1371/journal.pmed.1004523","url":null,"abstract":"<p><strong>Background: </strong>Understanding the effects of balanced energy and protein (BEP) supplements on gestational weight gain (GWG) and how the effects differ depending on maternal characteristics and the nutritional composition of the supplements will inform the implementation of prenatal BEP interventions.</p><p><strong>Methods and findings: </strong>Individual participant data from 11 randomized controlled trials of prenatal BEP supplements (N = 12,549, with 5,693 in the BEP arm and 6,856 in the comparison arm) in low- and middle-income countries were used. The primary outcomes included GWG adequacy (%) and the estimated total GWG at delivery as continuous outcomes, and severely inadequate (<70% adequacy), inadequate GWG (<90% adequacy), and excessive GWG (>125% adequacy) as binary outcomes; all variables were calculated based on the Institute of Medicine recommendations. Linear and log-binomial models were used to estimate study-specific mean differences or risk ratios (RRs), respectively, with 95% confidence intervals (CIs) of the effects of prenatal BEP on the GWG outcomes. The study-specific estimates were pooled using meta-analyses. Subgroup analyses were conducted by individual characteristics. Subgroup analyses and meta-regression were conducted for study-level characteristics. Compared to the comparison group, prenatal BEP led to a 6% greater GWG percent adequacy (95% CI: 2.18, 9.56; p = 0.002), a 0.59 kg greater estimated total GWG at delivery (95% CI, 0.12, 1.05; p = 0.014), a 10% lower risk of severely inadequate GWG (RR: 0.90; 95% CI: 0.83, 0.99; p = 0.025), and a 7% lower risk of inadequate GWG (RR: 0.93; 95% CI: 0.89, 0.97; p = 0.001). The effects of prenatal BEP on GWG outcomes were stronger in studies with a targeted approach, where BEP supplements were provided to participants in the intervention arm under specific criteria such as low body mass index or low GWG, compared to studies with an untargeted approach, where BEP supplements were provided to all participants allocated to the intervention arm.</p><p><strong>Conclusions: </strong>Prenatal BEP supplements are effective in increasing GWG and reducing the risk of inadequate weight gain during pregnancy. BEP supplementation targeted toward pregnant women with undernutrition may be a promising approach to delivering the supplements.</p>","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 2","pages":"e1004523"},"PeriodicalIF":15.8,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11790098/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123880","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":"Impact evaluation of a digital health platform empowering Kenyan women across the pregnancy-postpartum care continuum: A cluster randomized controlled trial.","authors":"Rajet Vatsa, Wei Chang, Sharon Akinyi, Sarah Little, Catherine Gakii, John Mungai, Cynthia Kahumbura, Anneka Wickramanayake, Sathyanath Rajasekharan, Jessica Cohen, Margaret McConnell","doi":"10.1371/journal.pmed.1004527","DOIUrl":"10.1371/journal.pmed.1004527","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Accelerating improvements in maternal and newborn health (MNH) care is a major public health priority in Kenya. While use of formal health care has increased, many pregnant and postpartum women do not receive the recommended number of maternal care visits. Even when they do, visits are often short with many providers not offering important elements of evaluation and counseling, leaving gaps in women's knowledge and preparedness. Digital health tools have been proposed as a complement to care that is provided by maternity care facilities, but there is limited evidence of the impact of digital health tools at scale on women's knowledge, preparedness, and the content of care they receive. We evaluated a digital health platform (PROMPTS (Promoting Mothers in Pregnancy and Postpartum Through SMS)) composed of informational messages, appointment reminders, and a two-way clinical helpdesk, which had enrolled over 750,000 women across Kenya at the time of our study, on 6 domains across the pregnancy-postpartum care continuum.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods and findings: &lt;/strong&gt;We conducted an unmasked, 1:1 parallel arm cluster randomized controlled trial in 40 health facilities (clusters) across 8 counties in Kenya. A total of 6,139 pregnant individuals were consented at baseline and followed through pregnancy and postpartum. Individuals recruited from treatment facilities were invited to enroll in the PROMPTS platform, with roughly 85% (1,453/1,700) reporting take-up. Our outcomes were derived from phone surveys conducted with participants at 36 to 42 weeks of gestation and 7 to 8 weeks post-childbirth. Among eligible participants, 3,399/3,678 women completed antenatal follow-up and 5,509/6,128 women completed postpartum follow-up, with response rates of 92% and 90%, respectively. Outcomes were organized into 6 domains: knowledge, birth preparedness, routine care seeking, danger sign care seeking, newborn care, and postpartum care content. We generated standardized summary indices to account for multiple hypothesis testing but also analyzed individual index components. Intention-to-treat analyses were conducted for all outcomes at the individual level, with standard errors clustered by facility. Participants recruited from treatment facilities had a 0.08 standard deviation (SD) (95% CI [0.03, 0.12]; p = 0.002) higher knowledge index, a 0.08 SD (95% CI [0.02, 0.13]; p = 0.018) higher birth preparedness index, a 0.07 SD (95% CI [0.03, 0.11]; p = 0.003) higher routine care seeking index, a 0.09 SD (95% CI [0.07, 0.12]; p &lt; 0.001) higher newborn care index, and a 0.06 SD (95% CI [0.01, 0.12]; p = 0.043) higher postpartum care content index than those recruited from control facilities. No significant effect on the danger sign care seeking index was found (95% CI [-0.01, 0.08]; p = 0.096). A limitation of our study was that outcomes were self-reported, and the study was not powered to detect effects on health outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;C","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 2","pages":"e1004527"},"PeriodicalIF":15.8,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11835334/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123874","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}