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Effects of X-ray-based diagnosis and explanation of knee osteoarthritis on patient beliefs about osteoarthritis management: A randomised clinical trial.
IF 15.8 1区 医学 Q1 Medicine Pub Date : 2025-02-04 DOI: 10.1371/journal.pmed.1004537
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
<p><strong>Background: </strong>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.</p><p><strong>Methods and findings: </strong>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,
{"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":"https://doi.org/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":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Consecutive prediction of adverse maternal outcomes of preeclampsia, using the PIERS-ML and fullPIERS models: A multicountry prospective observational study.
IF 15.8 1区 医学 Q1 Medicine Pub Date : 2025-02-04 eCollection Date: 2025-02-01 DOI: 10.1371/journal.pmed.1004509
Guiyou Yang, Tünde Montgomery-Csobán, Wessel Ganzevoort, Sanne J Gordijn, Kimberley Kavanagh, Paul Murray, Laura A Magee, Henk Groen, Peter von Dadelszen
<p><strong>Background: </strong>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.</p><p><strong>Methods and findings: </strong>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
{"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":"https://doi.org/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":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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.
IF 15.8 1区 医学 Q1 Medicine Pub Date : 2025-02-03 eCollection Date: 2025-02-01 DOI: 10.1371/journal.pmed.1004523
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

Background: 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.

Methods and findings: 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.

Conclusions: 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.

{"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}
引用次数: 0
Impact evaluation of a digital health platform empowering Kenyan women across the pregnancy-postpartum care continuum: A cluster randomized controlled trial.
IF 15.8 1区 医学 Q1 Medicine Pub Date : 2025-02-03 DOI: 10.1371/journal.pmed.1004527
Rajet Vatsa, Wei Chang, Sharon Akinyi, Sarah Little, Catherine Gakii, John Mungai, Cynthia Kahumbura, Anneka Wickramanayake, Sathyanath Rajasekharan, Jessica Cohen, Margaret McConnell
<p><strong>Background: </strong>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.</p><p><strong>Methods and findings: </strong>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 < 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.</p><p><strong>C
{"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":"https://doi.org/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":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Risk of placenta previa in assisted reproductive technology: A Nordic population study with sibling analyses.
IF 15.8 1区 医学 Q1 Medicine Pub Date : 2025-02-03 DOI: 10.1371/journal.pmed.1004536
Eirik Landsverk, Kjersti Westvik-Johari, Ulla-Britt Wennerholm, Christina Bergh, Frederik Kyhl, Anne Lærke Spangmose, Ditte Vassard, Anja Pinborg, Kristiina Rönö, Mika Gissler, Sindre Hoff Petersen, Signe Opdahl
<p><strong>Background: </strong>A higher risk of placenta previa after assisted reproductive technology (ART) is well established. The underlying mechanisms are poorly understood, but may relate to embryo culture duration, cryopreservation, and cause of infertility. Within-mother analyses, where each woman is her own control (i.e., sibling design), help disentangle treatment contributions from maternal confounders that are stable between pregnancies. We aimed to investigate the risk of placenta previa in pregnancies achieved after ART according to embryo culture duration, cryopreservation, and infertility factors while accounting for stable maternal factors using within-mother analyses.</p><p><strong>Methods and findings: </strong>We used linked nationwide registry data from Denmark (1994 to 2014), Finland (1990 to 2014), Norway (1988 to 2015), and Sweden (1988 to 2015). All women who gave their first birth during the study period at age 20 years or older were eligible and contributed up to 4 deliveries (singleton or multifetal) occurring between 22 and 44 weeks of gestation, excluding deliveries where maternal age exceeded 45 years. We used multilevel logistic regression to compare risk of placenta previa after ART (n = 139,694 deliveries) versus natural conception (n = 5,614,512 deliveries), both at the population level and within mothers, adjusting for year of delivery, maternal age, parity, and country. We categorized ART according to culture duration, embryo cryopreservation, and infertility factors. Population level risk of placenta previa was higher for ART versus natural conception (odds ratio [OR], 4.16; 95% confidence interval [CI], 3.96-4.37). Controlling for stable maternal factors, the association attenuated, but risk remained higher for ART versus natural conception (OR within mothers, 2.64; 95% CI, 2.31-3.02). Compared to naturally conceived, a larger difference in risk was seen for pregnancies from fresh embryos than for pregnancies from frozen embryos. Further categorization by culture duration showed the largest risk difference after fresh blastocyst transfer, and the smallest after frozen cleavage stage embryo transfer, which persisted in sensitivity analyses (including restriction to singletons). When stratified according to infertility factors at the population level, women with endometriosis conceiving by ART had the highest risk of placenta previa (OR, 9.35; 95% CI, 8.50-10.29), whereas women with polycystic ovary syndrome (PCOS) conceiving by ART had the lowest risk (OR, 1.52; 95% CI, 1.12-2.09), compared to natural conception. Within mothers, we found a higher risk of placenta previa after ART compared to natural conception for women with endometriosis (OR, 2.08; 95% CI, 1.50-2.90), but not for women with PCOS (OR, 0.88; 95% CI, 0.41-1.89 [unadjusted due to sparse data]). However, within-mother analyses are restricted to multiparous women with deliveries after different conception methods. Therefore, findings from these a
{"title":"Risk of placenta previa in assisted reproductive technology: A Nordic population study with sibling analyses.","authors":"Eirik Landsverk, Kjersti Westvik-Johari, Ulla-Britt Wennerholm, Christina Bergh, Frederik Kyhl, Anne Lærke Spangmose, Ditte Vassard, Anja Pinborg, Kristiina Rönö, Mika Gissler, Sindre Hoff Petersen, Signe Opdahl","doi":"10.1371/journal.pmed.1004536","DOIUrl":"https://doi.org/10.1371/journal.pmed.1004536","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;A higher risk of placenta previa after assisted reproductive technology (ART) is well established. The underlying mechanisms are poorly understood, but may relate to embryo culture duration, cryopreservation, and cause of infertility. Within-mother analyses, where each woman is her own control (i.e., sibling design), help disentangle treatment contributions from maternal confounders that are stable between pregnancies. We aimed to investigate the risk of placenta previa in pregnancies achieved after ART according to embryo culture duration, cryopreservation, and infertility factors while accounting for stable maternal factors using within-mother analyses.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods and findings: &lt;/strong&gt;We used linked nationwide registry data from Denmark (1994 to 2014), Finland (1990 to 2014), Norway (1988 to 2015), and Sweden (1988 to 2015). All women who gave their first birth during the study period at age 20 years or older were eligible and contributed up to 4 deliveries (singleton or multifetal) occurring between 22 and 44 weeks of gestation, excluding deliveries where maternal age exceeded 45 years. We used multilevel logistic regression to compare risk of placenta previa after ART (n = 139,694 deliveries) versus natural conception (n = 5,614,512 deliveries), both at the population level and within mothers, adjusting for year of delivery, maternal age, parity, and country. We categorized ART according to culture duration, embryo cryopreservation, and infertility factors. Population level risk of placenta previa was higher for ART versus natural conception (odds ratio [OR], 4.16; 95% confidence interval [CI], 3.96-4.37). Controlling for stable maternal factors, the association attenuated, but risk remained higher for ART versus natural conception (OR within mothers, 2.64; 95% CI, 2.31-3.02). Compared to naturally conceived, a larger difference in risk was seen for pregnancies from fresh embryos than for pregnancies from frozen embryos. Further categorization by culture duration showed the largest risk difference after fresh blastocyst transfer, and the smallest after frozen cleavage stage embryo transfer, which persisted in sensitivity analyses (including restriction to singletons). When stratified according to infertility factors at the population level, women with endometriosis conceiving by ART had the highest risk of placenta previa (OR, 9.35; 95% CI, 8.50-10.29), whereas women with polycystic ovary syndrome (PCOS) conceiving by ART had the lowest risk (OR, 1.52; 95% CI, 1.12-2.09), compared to natural conception. Within mothers, we found a higher risk of placenta previa after ART compared to natural conception for women with endometriosis (OR, 2.08; 95% CI, 1.50-2.90), but not for women with PCOS (OR, 0.88; 95% CI, 0.41-1.89 [unadjusted due to sparse data]). However, within-mother analyses are restricted to multiparous women with deliveries after different conception methods. Therefore, findings from these a","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 2","pages":"e1004536"},"PeriodicalIF":15.8,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123877","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}
引用次数: 0
Long-term drought and risk of infant mortality in Africa: A cross-sectional study.
IF 15.8 1区 医学 Q1 Medicine Pub Date : 2025-01-31 eCollection Date: 2025-01-01 DOI: 10.1371/journal.pmed.1004516
Pin Wang, Tormod Rogne, Joshua L Warren, Ernest O Asare, Robert A Akum, N'datchoh E Toure, Joseph S Ross, Kai Chen

Background: As extreme events such as drought and flood are projected to increase in frequency and intensity under climate change, there is still large missing evidence on how drought exposure potentially impacts mortality among young children. This study aimed to investigate the association between drought and risk of infant mortality in Africa, a region highly vulnerable to climate change that bears the heaviest share of the global burden.

Methods and findings: In this cross-sectional study, we obtained data on infant mortality in 34 African countries during 1992-2019 from the Demographic and Health Surveys program. We measured drought by the standardized precipitation evapotranspiration index at a timescale of 24 months and a spatial resolution of 10 × 10 km, which was further dichotomized into mild and severe drought. The association between drought exposure and infant mortality risk was estimated using Cox regression models allowing time-dependent covariates. We further examined whether the association varied for neonatal and post-neonatal mortality and whether there was a delayed association with drought exposure during pregnancy or infancy. The mean (standard deviation) number of months in which children experienced any drought during pregnancy and survival period (from birth through death before 1 year of age) was 4.6 (5.2) and 7.3 (7.4) among cases and non-cases, respectively. Compared to children who did not experience drought, we did not find evidence that any drought exposure was associated with an increased risk of infant mortality (hazard ratio [HR]: 1.02, 95% confidence interval [CI] [1.00, 1.04], p = 0.072). When stratified by drought severity, we found a statistically significant association with severe drought (HR: 1.04; 95% CI [1.01, 1.07], p = 0.015), but no significant association with mild drought (HR: 1.01; 95% CI [0.99, 1.03], p = 0.353), compared to non-exposure to any drought. However, when excluding drought exposure during pregnancy, the association with severe drought was found to be non-significant. In addition, an increased risk of neonatal mortality was associated with severe drought (HR: 1.05; 95% CI [1.01, 1.10], p = 0.019), but not with mild drought (HR: 0.99; 95% CI [0.96, 1.02], p = 0.657).

Conclusions: Exposure to long-term severe drought was associated with increased infant mortality risk in Africa. Our findings urge more effective adaptation measures and alleviation strategies against the adverse impact of drought on child health.

{"title":"Long-term drought and risk of infant mortality in Africa: A cross-sectional study.","authors":"Pin Wang, Tormod Rogne, Joshua L Warren, Ernest O Asare, Robert A Akum, N'datchoh E Toure, Joseph S Ross, Kai Chen","doi":"10.1371/journal.pmed.1004516","DOIUrl":"10.1371/journal.pmed.1004516","url":null,"abstract":"<p><strong>Background: </strong>As extreme events such as drought and flood are projected to increase in frequency and intensity under climate change, there is still large missing evidence on how drought exposure potentially impacts mortality among young children. This study aimed to investigate the association between drought and risk of infant mortality in Africa, a region highly vulnerable to climate change that bears the heaviest share of the global burden.</p><p><strong>Methods and findings: </strong>In this cross-sectional study, we obtained data on infant mortality in 34 African countries during 1992-2019 from the Demographic and Health Surveys program. We measured drought by the standardized precipitation evapotranspiration index at a timescale of 24 months and a spatial resolution of 10 × 10 km, which was further dichotomized into mild and severe drought. The association between drought exposure and infant mortality risk was estimated using Cox regression models allowing time-dependent covariates. We further examined whether the association varied for neonatal and post-neonatal mortality and whether there was a delayed association with drought exposure during pregnancy or infancy. The mean (standard deviation) number of months in which children experienced any drought during pregnancy and survival period (from birth through death before 1 year of age) was 4.6 (5.2) and 7.3 (7.4) among cases and non-cases, respectively. Compared to children who did not experience drought, we did not find evidence that any drought exposure was associated with an increased risk of infant mortality (hazard ratio [HR]: 1.02, 95% confidence interval [CI] [1.00, 1.04], p = 0.072). When stratified by drought severity, we found a statistically significant association with severe drought (HR: 1.04; 95% CI [1.01, 1.07], p = 0.015), but no significant association with mild drought (HR: 1.01; 95% CI [0.99, 1.03], p = 0.353), compared to non-exposure to any drought. However, when excluding drought exposure during pregnancy, the association with severe drought was found to be non-significant. In addition, an increased risk of neonatal mortality was associated with severe drought (HR: 1.05; 95% CI [1.01, 1.10], p = 0.019), but not with mild drought (HR: 0.99; 95% CI [0.96, 1.02], p = 0.657).</p><p><strong>Conclusions: </strong>Exposure to long-term severe drought was associated with increased infant mortality risk in Africa. Our findings urge more effective adaptation measures and alleviation strategies against the adverse impact of drought on child health.</p>","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 1","pages":"e1004516"},"PeriodicalIF":15.8,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785314/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143071320","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}
引用次数: 0
Ovarian cancer prevention through opportunistic salpingectomy during abdominal surgeries: A cost-effectiveness modeling study. 通过腹部手术中的机会性输卵管切除术预防卵巢癌:成本效益模型研究。
IF 15.8 1区 医学 Q1 Medicine Pub Date : 2025-01-30 eCollection Date: 2025-01-01 DOI: 10.1371/journal.pmed.1004514
Angela Kather, Habib Arefian, Claus Schneider, Michael Hartmann, Ingo B Runnebaum
<p><strong>Background: </strong>There is indication that the fallopian tubes might be involved in ovarian cancer pathogenesis and their removal reduces cancer risk. Hence, bilateral salpingectomy during hysterectomy or sterilization, so called opportunistic salpingectomy (OS), is gaining wide acceptance as a preventive strategy. Recently, it was discussed whether implementation of OS at other gynecologic surgery, e.g., cesarean section, endometriosis excision or myomectomy and even at non-gynecologic abdominal surgery such as cholecystectomy or appendectomy for women with completed family could be feasible. This modeling analysis evaluated the clinical and economic potential of OS at gynecologic and abdominal surgeries.</p><p><strong>Methods and findings: </strong>A state transition model representing all relevant health states (healthy, healthy with hysterectomy or tubal ligation, healthy with other gynecologic or non-gynecologic abdominal surgery, healthy with hysterectomy and salpingectomy, healthy with salpingectomy, healthy with hysterectomy and salpingo-oophorectomy, ovarian cancer and death) was developed and informed with transition probabilities based on inpatient case numbers in Germany (2019). Outcomes for women aged 20-85 years were simulated over annual cycles with 1,200,000 million individuals. We compared four strategies: (I) OS at any suitable abdominal surgery, (II) OS only at any suitable gynecologic surgery, (III) OS only at hysterectomy or sterilization, and (IV) no implementation of OS. Primary outcome measures were prevented ovarian cancer cases and deaths as well as the incremental cost-effectiveness ratio (ICER). Volume of eligible interventions in strategy I was 3.5 times greater than in strategy III (286,736 versus 82,319). With strategy IV as reference, ovarian cancer cases were reduced by 15.34% in strategy I, 9.78% in II, and 5.48% in III. Setting costs for OS to €216.19 (calculated from average OS duration and operating room minute costs), implementation of OS would lead to healthcare cost savings as indicated by an ICER of €-8,685.50 per quality-adjusted life year (QALY) gained for strategy I, €-8,270.55/QALY for II, and €-4,511.86/QALY for III. Sensitivity analyses demonstrated stable results over a wide range of input parameters with strategy I being the superior approach in the majority of simulations. However, the extent of cancer risk reduction after OS appeared as the critical factor for effectiveness. Preventable ovarian cancer cases dropped to 4.07% (I versus IV), 1.90% (II versus IV), and 0.37% (III versus IV) if risk reduction would be <27% (hazard ratio [HR] > 0.73). ICER of strategies I and II was lower than the 2× gross domestic product per capita (GDP/C) (€94,366/QALY, Germany 2022) within the range of all tested parameters, but strategy III exceeded this threshold in case-risk reduction was <35% (HR > 0.65). The study is limited to data from the inpatient sector and direct medical costs.</p><p><strong
{"title":"Ovarian cancer prevention through opportunistic salpingectomy during abdominal surgeries: A cost-effectiveness modeling study.","authors":"Angela Kather, Habib Arefian, Claus Schneider, Michael Hartmann, Ingo B Runnebaum","doi":"10.1371/journal.pmed.1004514","DOIUrl":"10.1371/journal.pmed.1004514","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;There is indication that the fallopian tubes might be involved in ovarian cancer pathogenesis and their removal reduces cancer risk. Hence, bilateral salpingectomy during hysterectomy or sterilization, so called opportunistic salpingectomy (OS), is gaining wide acceptance as a preventive strategy. Recently, it was discussed whether implementation of OS at other gynecologic surgery, e.g., cesarean section, endometriosis excision or myomectomy and even at non-gynecologic abdominal surgery such as cholecystectomy or appendectomy for women with completed family could be feasible. This modeling analysis evaluated the clinical and economic potential of OS at gynecologic and abdominal surgeries.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods and findings: &lt;/strong&gt;A state transition model representing all relevant health states (healthy, healthy with hysterectomy or tubal ligation, healthy with other gynecologic or non-gynecologic abdominal surgery, healthy with hysterectomy and salpingectomy, healthy with salpingectomy, healthy with hysterectomy and salpingo-oophorectomy, ovarian cancer and death) was developed and informed with transition probabilities based on inpatient case numbers in Germany (2019). Outcomes for women aged 20-85 years were simulated over annual cycles with 1,200,000 million individuals. We compared four strategies: (I) OS at any suitable abdominal surgery, (II) OS only at any suitable gynecologic surgery, (III) OS only at hysterectomy or sterilization, and (IV) no implementation of OS. Primary outcome measures were prevented ovarian cancer cases and deaths as well as the incremental cost-effectiveness ratio (ICER). Volume of eligible interventions in strategy I was 3.5 times greater than in strategy III (286,736 versus 82,319). With strategy IV as reference, ovarian cancer cases were reduced by 15.34% in strategy I, 9.78% in II, and 5.48% in III. Setting costs for OS to €216.19 (calculated from average OS duration and operating room minute costs), implementation of OS would lead to healthcare cost savings as indicated by an ICER of €-8,685.50 per quality-adjusted life year (QALY) gained for strategy I, €-8,270.55/QALY for II, and €-4,511.86/QALY for III. Sensitivity analyses demonstrated stable results over a wide range of input parameters with strategy I being the superior approach in the majority of simulations. However, the extent of cancer risk reduction after OS appeared as the critical factor for effectiveness. Preventable ovarian cancer cases dropped to 4.07% (I versus IV), 1.90% (II versus IV), and 0.37% (III versus IV) if risk reduction would be &lt;27% (hazard ratio [HR] &gt; 0.73). ICER of strategies I and II was lower than the 2× gross domestic product per capita (GDP/C) (€94,366/QALY, Germany 2022) within the range of all tested parameters, but strategy III exceeded this threshold in case-risk reduction was &lt;35% (HR &gt; 0.65). The study is limited to data from the inpatient sector and direct medical costs.&lt;/p&gt;&lt;p&gt;&lt;strong","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 1","pages":"e1004514"},"PeriodicalIF":15.8,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11781718/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068757","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}
引用次数: 0
Cost-effectiveness of leveraging existing HIV primary health systems and community health workers for hypertension screening and treatment in Africa: An individual-based modeling study.
IF 15.8 1区 医学 Q1 Medicine Pub Date : 2025-01-24 DOI: 10.1371/journal.pmed.1004531
Matthew D Hickey, James Ayieko, Jane Kabami, Asiphas Owaraganise, Elijah Kakande, Sabina Ogachi, Colette I Aoko, Erick M Wafula, Norton Sang, Helen Sunday, Paul Revill, Loveleen Bansi-Matharu, Starley B Shade, Gabriel Chamie, Laura B Balzer, Maya L Petersen, Diane V Havlir, Moses R Kamya, Andrew N Phillips

Background: Cardiovascular disease (CVD) morbidity and mortality is increasing in Africa, largely due to undiagnosed and untreated hypertension. Approaches that leverage existing primary health systems could improve hypertension treatment and reduce CVD, but cost-effectiveness is unknown. We evaluated the cost-effectiveness of population-level hypertension screening and implementation of chronic care clinics across eastern, southern, central, and western Africa.

Methods and findings: We conducted a modeling study to simulate hypertension and CVD across 3,000 scenarios representing a range of settings across eastern, southern, central, and western Africa. We evaluated 2 policies compared to current hypertension treatment: (1) expansion of HIV primary care clinics into chronic care clinics that provide hypertension treatment for all persons regardless of HIV status (chronic care clinic or CCC policy); and (2) CCC plus population-level hypertension screening of adults ≥40 years of age by community health workers (CHW policy). For our primary analysis, we used a cost-effectiveness threshold of US $500 per disability-adjusted life-year (DALY) averted, a 3% annual discount rate, and a 50-year time horizon. A strategy was considered cost-effective if it led to the lowest net DALYs, which is a measure of DALY burden that takes account of the DALY implications of the cost for a given cost-effectiveness threshold. Among adults 45 to 64 years, CCC implementation would improve population-level hypertension control (the proportion of people with hypertension whose blood pressure is controlled) from mean 4% (90% range 1% to 7%) to 14% (6% to 26%); additional CHW screening would improve control to 44% (35% to 54%). Among all adults, CCC implementation would reduce ischemic heart disease (IHD) incidence by 10% (3% to 17%), strokes by 13% (5% to 23%), and CVD mortality by 9% (3% to 15%). CCC plus CHW screening would reduce IHD by 28% (19% to 36%), strokes by 36% (25% to 47%), and CVD mortality by 25% (17% to 34%). CHW screening was cost-effective in 62% of scenarios, CCC in 31%, and neither policy was cost-effective in 7% of scenarios. Pooling across setting-scenarios, incremental cost-effectiveness ratios were $69/DALY averted for CCC and $389/DALY averted adding CHW screening to CCC.

Conclusions: Leveraging existing healthcare infrastructure to implement population-level hypertension screening by CHWs and hypertension treatment through integrated chronic care clinics is expected to reduce CVD morbidity and mortality and is likely to be cost-effective in most settings across Africa.

背景:在非洲,心血管疾病(CVD)的发病率和死亡率不断上升,主要原因是高血压未得到诊断和治疗。利用现有初级卫生系统的方法可以改善高血压治疗并减少心血管疾病,但成本效益尚不清楚。我们评估了非洲东部、南部、中部和西部人群高血压筛查和慢性病护理诊所的成本效益:我们进行了一项建模研究,模拟了非洲东部、南部、中部和西部各种环境下的 3000 种高血压和心血管疾病情况。与目前的高血压治疗相比,我们评估了两种政策:(1) 将 HIV 初级保健诊所扩展为慢性病保健诊所,为所有人提供高血压治疗,无论其是否感染 HIV(慢性病保健诊所或 CCC 政策);(2) CCC 加上由社区保健工作者对年龄≥40 岁的成年人进行人群高血压筛查(CHW 政策)。在主要分析中,我们采用的成本效益阈值为每避免 1 个残疾调整生命年(DALY)500 美元,年贴现率为 3%,时间跨度为 50 年。如果一项策略导致的净残疾调整寿命年数最少,则该策略被认为具有成本效益,净残疾调整寿命年数是衡量残疾调整寿命年数负担的一个指标,它考虑了特定成本效益阈值的成本对残疾调整寿命年数的影响。在 45 至 64 岁的成年人中,实施 CCC 将使人群高血压控制率(血压得到控制的高血压患者比例)从平均 4%(90% 的范围为 1%至 7%)提高到 14%(6% 至 26%);额外的 CHW 筛查将使控制率提高到 44%(35% 至 54%)。在所有成年人中,CCC 的实施将使缺血性心脏病(IHD)发病率降低 10%(3% 至 17%),中风发病率降低 13%(5% 至 23%),心血管疾病死亡率降低 9%(3% 至 15%)。CCC加CHW筛查可使IHD发病率降低28%(19%至36%),中风发病率降低36%(25%至47%),心血管疾病死亡率降低25%(17%至34%)。在 62% 的方案中,CHW 筛查具有成本效益;在 31% 的方案中,CCC 筛查具有成本效益;在 7% 的方案中,两种政策均不具有成本效益。汇总不同的设置方案,CCC 的增量成本效益比为 69 美元/减少的残疾年,在 CCC 的基础上增加 CHW 筛查的增量成本效益比为 389 美元/减少的残疾年:利用现有的医疗保健基础设施,由社区保健员实施人群高血压筛查,并通过综合慢性病诊所进行高血压治疗,有望降低心血管疾病的发病率和死亡率,而且在非洲的大多数环境中可能具有成本效益。
{"title":"Cost-effectiveness of leveraging existing HIV primary health systems and community health workers for hypertension screening and treatment in Africa: An individual-based modeling study.","authors":"Matthew D Hickey, James Ayieko, Jane Kabami, Asiphas Owaraganise, Elijah Kakande, Sabina Ogachi, Colette I Aoko, Erick M Wafula, Norton Sang, Helen Sunday, Paul Revill, Loveleen Bansi-Matharu, Starley B Shade, Gabriel Chamie, Laura B Balzer, Maya L Petersen, Diane V Havlir, Moses R Kamya, Andrew N Phillips","doi":"10.1371/journal.pmed.1004531","DOIUrl":"10.1371/journal.pmed.1004531","url":null,"abstract":"<p><strong>Background: </strong>Cardiovascular disease (CVD) morbidity and mortality is increasing in Africa, largely due to undiagnosed and untreated hypertension. Approaches that leverage existing primary health systems could improve hypertension treatment and reduce CVD, but cost-effectiveness is unknown. We evaluated the cost-effectiveness of population-level hypertension screening and implementation of chronic care clinics across eastern, southern, central, and western Africa.</p><p><strong>Methods and findings: </strong>We conducted a modeling study to simulate hypertension and CVD across 3,000 scenarios representing a range of settings across eastern, southern, central, and western Africa. We evaluated 2 policies compared to current hypertension treatment: (1) expansion of HIV primary care clinics into chronic care clinics that provide hypertension treatment for all persons regardless of HIV status (chronic care clinic or CCC policy); and (2) CCC plus population-level hypertension screening of adults ≥40 years of age by community health workers (CHW policy). For our primary analysis, we used a cost-effectiveness threshold of US $500 per disability-adjusted life-year (DALY) averted, a 3% annual discount rate, and a 50-year time horizon. A strategy was considered cost-effective if it led to the lowest net DALYs, which is a measure of DALY burden that takes account of the DALY implications of the cost for a given cost-effectiveness threshold. Among adults 45 to 64 years, CCC implementation would improve population-level hypertension control (the proportion of people with hypertension whose blood pressure is controlled) from mean 4% (90% range 1% to 7%) to 14% (6% to 26%); additional CHW screening would improve control to 44% (35% to 54%). Among all adults, CCC implementation would reduce ischemic heart disease (IHD) incidence by 10% (3% to 17%), strokes by 13% (5% to 23%), and CVD mortality by 9% (3% to 15%). CCC plus CHW screening would reduce IHD by 28% (19% to 36%), strokes by 36% (25% to 47%), and CVD mortality by 25% (17% to 34%). CHW screening was cost-effective in 62% of scenarios, CCC in 31%, and neither policy was cost-effective in 7% of scenarios. Pooling across setting-scenarios, incremental cost-effectiveness ratios were $69/DALY averted for CCC and $389/DALY averted adding CHW screening to CCC.</p><p><strong>Conclusions: </strong>Leveraging existing healthcare infrastructure to implement population-level hypertension screening by CHWs and hypertension treatment through integrated chronic care clinics is expected to reduce CVD morbidity and mortality and is likely to be cost-effective in most settings across Africa.</p>","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 1","pages":"e1004531"},"PeriodicalIF":15.8,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143034609","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}
引用次数: 0
Comparative cardiometabolic safety and effectiveness of aripiprazole in people with severe mental illness: A target trial emulation.
IF 15.8 1区 医学 Q1 Medicine Pub Date : 2025-01-23 eCollection Date: 2025-01-01 DOI: 10.1371/journal.pmed.1004520
Alvin Richards-Belle, Naomi Launders, Sarah Hardoon, Al Richards, Kenneth K C Man, Neil M Davies, Elvira Bramon, Joseph F Hayes, David P J Osborn
<p><strong>Background: </strong>There is limited and conflicting evidence on the comparative cardiometabolic safety and effectiveness of aripiprazole in the management of severe mental illness. We investigated the hypothesis that aripiprazole has a favourable cardiometabolic profile, but similar effectiveness when compared to olanzapine, quetiapine, and risperidone.</p><p><strong>Methods and findings: </strong>We conducted an observational emulation of a head-to-head trial of aripiprazole versus olanzapine, quetiapine, and risperidone in UK primary care using data from the Clinical Practice Research Datalink. We included adults diagnosed with severe mental illness (i.e., bipolar disorder, schizophrenia, and other non-organic psychoses) who were prescribed a new antipsychotic between 2005 and 2017, with a 2-year follow-up to 2019. The primary outcome was total cholesterol at 1 year (cardiometabolic safety). The main secondary outcome was psychiatric hospitalisation (effectiveness). Other outcomes included body weight, blood pressure, all-cause discontinuation, and mortality. Analyses adjusted for baseline confounders, including sociodemographics, diagnoses, concomitant medications, and cardiometabolic parameters. We included 26,537 patients (aripiprazole, n = 3,573, olanzapine, n = 8,554, quetiapine, n = 8,289, risperidone, n = 6,121). Median (IQR) age was 53 (42-67) years, 55.4% were female, 82.3% White, and 18.0% were diagnosed with schizophrenia. Patients prescribed aripiprazole had similar total cholesterol levels after 1 year to those prescribed olanzapine (adjusted mean difference [aMD], -0.03, 95% CI, -0.09 to 0.02, p = 0.261), quetiapine (aMD, -0.03, 95% CI, -0.09 to 0.03, p = 0.324), and risperidone (aMD, -0.01, 95% CI, -0.08 to 0.05, p = 0.707). However, there was evidence that patients prescribed aripiprazole had better outcomes on other cardiometabolic parameters, such as body weight and blood pressure, especially compared to olanzapine. After additional adjustment for prior hospitalisation, patients prescribed aripiprazole had similar rates of psychiatric hospitalisation as those prescribed olanzapine (adjusted hazard ratio [aHR], 0.91, 95% CI, 0.82 to 1.01, p = 0.078), quetiapine (aHR, 0.94, 95% CI, 0.85 to 1.04, p = 0.230), or risperidone (aHR, 1.01, 95% CI, 0.91 to 1.12, p = 0.854).</p><p><strong>Conclusions: </strong>Data from our large, powered, diverse, real-world target trial emulation sample, followed over 2 years, suggest that adults diagnosed with severe mental illness prescribed aripiprazole have similar total cholesterol 1 year after first prescription compared to those prescribed olanzapine, quetiapine, and risperidone. However, patients prescribed aripiprazole had better outcomes on some other cardiometabolic parameters, and there was little evidence of differences in effectiveness. Our findings inform a common clinical dilemma and contribute to the evidence base for real-world clinical decision-making on antipsychotic c
{"title":"Comparative cardiometabolic safety and effectiveness of aripiprazole in people with severe mental illness: A target trial emulation.","authors":"Alvin Richards-Belle, Naomi Launders, Sarah Hardoon, Al Richards, Kenneth K C Man, Neil M Davies, Elvira Bramon, Joseph F Hayes, David P J Osborn","doi":"10.1371/journal.pmed.1004520","DOIUrl":"10.1371/journal.pmed.1004520","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;There is limited and conflicting evidence on the comparative cardiometabolic safety and effectiveness of aripiprazole in the management of severe mental illness. We investigated the hypothesis that aripiprazole has a favourable cardiometabolic profile, but similar effectiveness when compared to olanzapine, quetiapine, and risperidone.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods and findings: &lt;/strong&gt;We conducted an observational emulation of a head-to-head trial of aripiprazole versus olanzapine, quetiapine, and risperidone in UK primary care using data from the Clinical Practice Research Datalink. We included adults diagnosed with severe mental illness (i.e., bipolar disorder, schizophrenia, and other non-organic psychoses) who were prescribed a new antipsychotic between 2005 and 2017, with a 2-year follow-up to 2019. The primary outcome was total cholesterol at 1 year (cardiometabolic safety). The main secondary outcome was psychiatric hospitalisation (effectiveness). Other outcomes included body weight, blood pressure, all-cause discontinuation, and mortality. Analyses adjusted for baseline confounders, including sociodemographics, diagnoses, concomitant medications, and cardiometabolic parameters. We included 26,537 patients (aripiprazole, n = 3,573, olanzapine, n = 8,554, quetiapine, n = 8,289, risperidone, n = 6,121). Median (IQR) age was 53 (42-67) years, 55.4% were female, 82.3% White, and 18.0% were diagnosed with schizophrenia. Patients prescribed aripiprazole had similar total cholesterol levels after 1 year to those prescribed olanzapine (adjusted mean difference [aMD], -0.03, 95% CI, -0.09 to 0.02, p = 0.261), quetiapine (aMD, -0.03, 95% CI, -0.09 to 0.03, p = 0.324), and risperidone (aMD, -0.01, 95% CI, -0.08 to 0.05, p = 0.707). However, there was evidence that patients prescribed aripiprazole had better outcomes on other cardiometabolic parameters, such as body weight and blood pressure, especially compared to olanzapine. After additional adjustment for prior hospitalisation, patients prescribed aripiprazole had similar rates of psychiatric hospitalisation as those prescribed olanzapine (adjusted hazard ratio [aHR], 0.91, 95% CI, 0.82 to 1.01, p = 0.078), quetiapine (aHR, 0.94, 95% CI, 0.85 to 1.04, p = 0.230), or risperidone (aHR, 1.01, 95% CI, 0.91 to 1.12, p = 0.854).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Data from our large, powered, diverse, real-world target trial emulation sample, followed over 2 years, suggest that adults diagnosed with severe mental illness prescribed aripiprazole have similar total cholesterol 1 year after first prescription compared to those prescribed olanzapine, quetiapine, and risperidone. However, patients prescribed aripiprazole had better outcomes on some other cardiometabolic parameters, and there was little evidence of differences in effectiveness. Our findings inform a common clinical dilemma and contribute to the evidence base for real-world clinical decision-making on antipsychotic c","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 1","pages":"e1004520"},"PeriodicalIF":15.8,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11778676/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143030159","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}
引用次数: 0
Child mortality in England after national lockdowns for COVID-19: An analysis of childhood deaths, 2019-2023.
IF 15.8 1区 医学 Q1 Medicine Pub Date : 2025-01-23 eCollection Date: 2025-01-01 DOI: 10.1371/journal.pmed.1004417
David Odd, Sylvia Stoianova, Tom Williams, Peter Fleming, Karen Luyt
<p><strong>Background: </strong>During the COVID-19 pandemic children and young people (CYP) mortality in England reduced to the lowest on record, but it is unclear if the mechanisms which facilitated a reduction in mortality had a longer lasting impact, and what impact the pandemic, and its social restrictions, have had on deaths with longer latencies (e.g., malignancies). The aim of this analysis was to quantify the relative rate, and causes, of childhood deaths in England, before, during, and after national lockdowns for COVID-19 and its social changes.</p><p><strong>Methods and findings: </strong>Deaths of all children (occurring before their 18th birthday) occurring from April 2019 until March 2023 in England were identified. Data were collated by the National Child Mortality Database. Study population size and the underlying population profile was derived from 2021 Office of National Statistics census data Mortality for each analysis year was calculated per 1,000,000 person years. Poisson regression was used to test for an overall trend across the time period and tested if trends differed between April 2019 to March 2021 (Period 1)) and April 2021 to March 2023 (Period 2: after lockdown restrictions). This was then repeated for each category of death and demographic group. Twelve thousand eight hundred twenty-eight deaths were included in the analysis. Around 59.4% of deaths occurred under 1 year of age, 57.0% were male, and 63.9% were of white ethnicity. Mortality rate (per 1,000,000 CYP per year) dropped from 274.2 (95% CI 264.8-283.8) in 2019-2020, to 242.2 (95% CI 233.4-251.2) in 2020-2021, increasing to 296.1 (95% CI 286.3-306.1) in 2022-2023. Overall, death rate reduced across Period 1 (Incidence rate ratio (IRR) 0.96 (95% CI 0.92-0.99)) and then increased across Period 2 (IRR 1.12 (95% CI 1.08-1.16)), and this pattern was also seen for death by Infection and Underlying Disease. In contrast, rate of death after Intrapartum events increased across the first period, followed by a decrease in rate in the second (Period 1 IRR 1.15 (95% CI 1.00-1.34)) versus Period 2 (IRR 0.78 (95% CI 0.68-0.91), pdifference = 0.004). Rates of death from preterm birth, trauma and sudden unexpected deaths in infancy and childhood (SUDIC), increased across the entire 4-year-study period (preterm birth, IRR 1.03 (95% CI 1.00-1.07); trauma IRR 1.12 (95% CI 1.06-1.20); SUDIC IRR 1.09 (95% CI 1.04-1.13)), and there was no change in the rate of death from Malignancy (IRR 1.01 (95% CI 0.95-1.06)). Repeating the analysis, split by child characteristics, suggested that mortality initially dropped and subsequently rose for children between 1 and 4 years old (Period 1 RR 0.85 (95% CI 0.76-0.94) versus Period 2 IRR 1.31 (95% CI 1.19-1.43), pdifference < 0.001. For Asian, black and Other ethnic groups, we observed increased rates of deaths in the period 2021-2023, and a significant change in trajectory of death rates between Periods 1 and 2 (Asian (Period 1 IRR 0.93 (95
{"title":"Child mortality in England after national lockdowns for COVID-19: An analysis of childhood deaths, 2019-2023.","authors":"David Odd, Sylvia Stoianova, Tom Williams, Peter Fleming, Karen Luyt","doi":"10.1371/journal.pmed.1004417","DOIUrl":"10.1371/journal.pmed.1004417","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;During the COVID-19 pandemic children and young people (CYP) mortality in England reduced to the lowest on record, but it is unclear if the mechanisms which facilitated a reduction in mortality had a longer lasting impact, and what impact the pandemic, and its social restrictions, have had on deaths with longer latencies (e.g., malignancies). The aim of this analysis was to quantify the relative rate, and causes, of childhood deaths in England, before, during, and after national lockdowns for COVID-19 and its social changes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods and findings: &lt;/strong&gt;Deaths of all children (occurring before their 18th birthday) occurring from April 2019 until March 2023 in England were identified. Data were collated by the National Child Mortality Database. Study population size and the underlying population profile was derived from 2021 Office of National Statistics census data Mortality for each analysis year was calculated per 1,000,000 person years. Poisson regression was used to test for an overall trend across the time period and tested if trends differed between April 2019 to March 2021 (Period 1)) and April 2021 to March 2023 (Period 2: after lockdown restrictions). This was then repeated for each category of death and demographic group. Twelve thousand eight hundred twenty-eight deaths were included in the analysis. Around 59.4% of deaths occurred under 1 year of age, 57.0% were male, and 63.9% were of white ethnicity. Mortality rate (per 1,000,000 CYP per year) dropped from 274.2 (95% CI 264.8-283.8) in 2019-2020, to 242.2 (95% CI 233.4-251.2) in 2020-2021, increasing to 296.1 (95% CI 286.3-306.1) in 2022-2023. Overall, death rate reduced across Period 1 (Incidence rate ratio (IRR) 0.96 (95% CI 0.92-0.99)) and then increased across Period 2 (IRR 1.12 (95% CI 1.08-1.16)), and this pattern was also seen for death by Infection and Underlying Disease. In contrast, rate of death after Intrapartum events increased across the first period, followed by a decrease in rate in the second (Period 1 IRR 1.15 (95% CI 1.00-1.34)) versus Period 2 (IRR 0.78 (95% CI 0.68-0.91), pdifference = 0.004). Rates of death from preterm birth, trauma and sudden unexpected deaths in infancy and childhood (SUDIC), increased across the entire 4-year-study period (preterm birth, IRR 1.03 (95% CI 1.00-1.07); trauma IRR 1.12 (95% CI 1.06-1.20); SUDIC IRR 1.09 (95% CI 1.04-1.13)), and there was no change in the rate of death from Malignancy (IRR 1.01 (95% CI 0.95-1.06)). Repeating the analysis, split by child characteristics, suggested that mortality initially dropped and subsequently rose for children between 1 and 4 years old (Period 1 RR 0.85 (95% CI 0.76-0.94) versus Period 2 IRR 1.31 (95% CI 1.19-1.43), pdifference &lt; 0.001. For Asian, black and Other ethnic groups, we observed increased rates of deaths in the period 2021-2023, and a significant change in trajectory of death rates between Periods 1 and 2 (Asian (Period 1 IRR 0.93 (95","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 1","pages":"e1004417"},"PeriodicalIF":15.8,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11756792/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143030156","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}
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