Pub Date : 2024-09-17DOI: 10.1371/journal.pmed.1004442
Eleni Mantzari, Gareth J. Hollands, Martin Law, Dominique-Laurent Couturier, Theresa M. Marteau
Background Smaller serving sizes could contribute towards reducing alcohol consumption across populations and thereby decrease the risk of 7 cancers and other diseases. To our knowledge, the current study is the first to assess the impact on beer, lager, and cider sales (hereafter, for ease, referred to just as “beer sales”) of removing the largest draught serving size (1 imperial pint) from the options available in licensed premises under real-word conditions. Methods and findings The study was conducted between February and May 2023, in 13 licensed premises in England. It used an A-B-A reversal design, set over 3 consecutive 4-weekly periods with “A” representing the nonintervention periods during which standard serving sizes were served, and “B” representing the intervention period when the largest serving size of draught beer (1 imperial pint (568 ml)) was removed from existing ranges so that the largest size available was two-thirds of a pint. Where two-third pints were not served, the intervention included introducing this serving size in conjunction with removing the pint serving size. The primary outcome was the mean daily volume of all beer sold, including draught, bottles, and cans (in ml), extracted from electronic sales data. Secondary outcomes were mean daily volume of wine sold (ml) and daily revenue (£). Thirteen premises completed the study, 12 of which did so per protocol and were included in the primary analysis. After adjusting for prespecified covariates, the intervention resulted in a mean daily change of −2,769 ml (95% CI [−4,188, −1,578] p < 0.001) or −9.7% (95% CI [−13.5%, −6.1%] in beer sold. The daily volume of wine sold increased during the intervention period by 232 ml (95% CI [13, 487], p = 0.035) or 7.2% (95% CI [0.4%, 14.5%]). Daily revenues decreased by 5.0% (95% CI [9.6%, −0.3%], p = 0.038). Conclusions Removing the largest serving size (the imperial pint) for draught beer reduced the volume of beer sold. Given the potential of this intervention to reduce alcohol consumption, it merits consideration in alcohol control policies. Trial registration ISRCTN.com ISRCTN18365249.
背景较小的食用分量有助于减少人口中的酒精消费量，从而降低罹患 7 种癌症和其他疾病的风险。据我们所知，目前的研究是首次评估在真实条件下，从持证经营场所的选择中取消最大的吃水份量（1 英制品脱）对啤酒、拉格啤酒和苹果酒销量（以下简称 "啤酒销量"）的影响。研究方法和结果 这项研究于 2023 年 2 月至 5 月间在英格兰 13 个持证经营场所进行。研究采用了 A-B-A 反转设计，连续 3 次，每次 4 周，其中 "A "代表非干预期，在此期间提供标准份量的啤酒；"B "代表干预期，在此期间，最大份量的扎啤（1 英制品脱（568 毫升））从现有范围中去除，因此最大份量为三分之二品脱。在不供应三分之二品脱啤酒的地方，干预措施包括在取消一品脱啤酒供应量的同时引入这种供应量。主要结果是从电子销售数据中提取的所有啤酒的日平均销售量，包括扎啤、瓶装啤酒和罐装啤酒（单位：毫升）。次要结果是葡萄酒的日平均销售量（毫升）和日收入（英镑）。有 13 个场所完成了研究，其中 12 个场所按照协议完成了研究，并纳入了主要分析。在对预设的协变量进行调整后，干预措施导致平均日销售量变化为-2,769 毫升（95% CI [-4,188, -1,578] p < 0.001）或啤酒销售量变化为-9.7%（95% CI [-13.5%, -6.1%]）。在干预期间，葡萄酒的日销售量增加了 232 毫升（95% CI [13, 487]，p = 0.035）或 7.2%（95% CI [0.4%, 14.5%]）。每日收入减少 5.0% (95% CI [9.6%, -0.3%], p = 0.038)。结论 取消生啤的最大份量（英制品脱）减少了啤酒的销售量。鉴于这种干预措施具有减少酒精消费的潜力，值得在酒精控制政策中加以考虑。试验注册 ISRCTN.com ISRCTN18365249。
{"title":"Impact on beer sales of removing the pint serving size: An A-B-A reversal trial in pubs, bars, and restaurants in England","authors":"Eleni Mantzari, Gareth J. Hollands, Martin Law, Dominique-Laurent Couturier, Theresa M. Marteau","doi":"10.1371/journal.pmed.1004442","DOIUrl":"https://doi.org/10.1371/journal.pmed.1004442","url":null,"abstract":"Background Smaller serving sizes could contribute towards reducing alcohol consumption across populations and thereby decrease the risk of 7 cancers and other diseases. To our knowledge, the current study is the first to assess the impact on beer, lager, and cider sales (hereafter, for ease, referred to just as “beer sales”) of removing the largest draught serving size (1 imperial pint) from the options available in licensed premises under real-word conditions. Methods and findings The study was conducted between February and May 2023, in 13 licensed premises in England. It used an A-B-A reversal design, set over 3 consecutive 4-weekly periods with “A” representing the nonintervention periods during which standard serving sizes were served, and “B” representing the intervention period when the largest serving size of draught beer (1 imperial pint (568 ml)) was removed from existing ranges so that the largest size available was two-thirds of a pint. Where two-third pints were not served, the intervention included introducing this serving size in conjunction with removing the pint serving size. The primary outcome was the mean daily volume of all beer sold, including draught, bottles, and cans (in ml), extracted from electronic sales data. Secondary outcomes were mean daily volume of wine sold (ml) and daily revenue (£). Thirteen premises completed the study, 12 of which did so per protocol and were included in the primary analysis. After adjusting for prespecified covariates, the intervention resulted in a mean daily change of −2,769 ml (95% CI [−4,188, −1,578] <jats:italic>p</jats:italic> < 0.001) or −9.7% (95% CI [−13.5%, −6.1%] in beer sold. The daily volume of wine sold increased during the intervention period by 232 ml (95% CI [13, 487], <jats:italic>p</jats:italic> = 0.035) or 7.2% (95% CI [0.4%, 14.5%]). Daily revenues decreased by 5.0% (95% CI [9.6%, −0.3%], <jats:italic>p</jats:italic> = 0.038). Conclusions Removing the largest serving size (the imperial pint) for draught beer reduced the volume of beer sold. Given the potential of this intervention to reduce alcohol consumption, it merits consideration in alcohol control policies. Trial registration ISRCTN.com <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" xlink:href=\"https://www.isrctn.com/ISRCTN18365249\" xlink:type=\"simple\">ISRCTN18365249</jats:ext-link>.","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":"16 1","pages":""},"PeriodicalIF":15.8,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142253269","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}
Pub Date : 2024-09-17DOI: 10.1371/journal.pmed.1004455
Yachen Zhu, Laura Llamosas-Falcón, William C. Kerr, Jürgen Rehm, Charlotte Probst
Background Ischemic heart disease (IHD) is a major cause of death in the United States (US), with marked mortality inequalities. Previous studies have reported inconsistent findings regarding the contributions of behavioral risk factors (BRFs) to socioeconomic inequalities in IHD mortality. To our knowledge, no nationwide study has been conducted on this topic in the US. Methods and findings In this cohort study, we obtained data from the 1997 to 2018 National Health Interview Survey with mortality follow-up until December 31, 2019 from the National Death Index. A total of 524,035 people aged 25 years and older were followed up for 10.3 years on average (SD: 6.1 years), during which 13,256 IHD deaths occurred. Counterfactual-based causal mediation analyses with Cox proportional hazards models were performed to quantify the contributions of 4 BRFs (smoking, alcohol use, physical inactivity, and BMI) to socioeconomic inequalities in IHD mortality. Education was used as the primary indicator for socioeconomic status (SES). Analyses were performed stratified by sex and adjusted for marital status, race and ethnicity, and survey year. In both males and females, clear socioeconomic gradients in IHD mortality were observed, with low- and middle-education people bearing statistically significantly higher risks compared to high-education people. We found statistically significant natural direct effects of SES (HR = 1.16, 95% CI: 1.06, 1.27 in males; HR = 1.28, 95% CI: 1.10, 1.49 in females) on IHD mortality and natural indirect effects through the causal pathways of smoking (HR = 1.18, 95% CI: 1.15, 1.20 in males; HR = 1.11, 95% CI: 1.08, 1.13 in females), physical inactivity (HR = 1.16, 95% CI: 1.14, 1.19 in males; HR = 1.18, 95% CI: 1.15, 1.20 in females), alcohol use (HR = 1.07, 95% CI: 1.06, 1.09 in males; HR = 1.09, 95% CI: 1.08, 1.11 in females), and BMI (HR = 1.03, 95% CI: 1.02, 1.04 in males; HR = 1.03, 95% CI: 1.02, 1.04 in females). Smoking, physical inactivity, alcohol use, and BMI mediated 29% (95% CI, 24%, 35%), 27% (95% CI, 22%, 33%), 12% (95% CI, 10%, 16%), and 5% (95% CI, 4%, 7%) of the inequalities in IHD mortality between low- and high-education males, respectively; the corresponding proportions mediated were 16% (95% CI, 11%, 23%), 26% (95% CI, 20%, 34%), 14% (95% CI, 11%, 19%), and 5% (95% CI, 3%, 7%) in females. Proportions mediated were slightly lower with family income used as the secondary indicator for SES. The main limitation of the methodology is that we could not rule out residual exposure-mediator, exposure-outcome, and mediator-outcome confounding. Conclusions In this study, BRFs explained more than half of the educational differences in IHD mortality, with some variations by sex. Public health interventions to reduce intermediate risk factors are crucial to reduce the socioeconomic disparities and burden of IHD mortality in the general US population.
{"title":"Behavioral risk factors and socioeconomic inequalities in ischemic heart disease mortality in the United States: A causal mediation analysis using record linkage data","authors":"Yachen Zhu, Laura Llamosas-Falcón, William C. Kerr, Jürgen Rehm, Charlotte Probst","doi":"10.1371/journal.pmed.1004455","DOIUrl":"https://doi.org/10.1371/journal.pmed.1004455","url":null,"abstract":"Background Ischemic heart disease (IHD) is a major cause of death in the United States (US), with marked mortality inequalities. Previous studies have reported inconsistent findings regarding the contributions of behavioral risk factors (BRFs) to socioeconomic inequalities in IHD mortality. To our knowledge, no nationwide study has been conducted on this topic in the US. Methods and findings In this cohort study, we obtained data from the 1997 to 2018 National Health Interview Survey with mortality follow-up until December 31, 2019 from the National Death Index. A total of 524,035 people aged 25 years and older were followed up for 10.3 years on average (SD: 6.1 years), during which 13,256 IHD deaths occurred. Counterfactual-based causal mediation analyses with Cox proportional hazards models were performed to quantify the contributions of 4 BRFs (smoking, alcohol use, physical inactivity, and BMI) to socioeconomic inequalities in IHD mortality. Education was used as the primary indicator for socioeconomic status (SES). Analyses were performed stratified by sex and adjusted for marital status, race and ethnicity, and survey year. In both males and females, clear socioeconomic gradients in IHD mortality were observed, with low- and middle-education people bearing statistically significantly higher risks compared to high-education people. We found statistically significant natural direct effects of SES (HR = 1.16, 95% CI: 1.06, 1.27 in males; HR = 1.28, 95% CI: 1.10, 1.49 in females) on IHD mortality and natural indirect effects through the causal pathways of smoking (HR = 1.18, 95% CI: 1.15, 1.20 in males; HR = 1.11, 95% CI: 1.08, 1.13 in females), physical inactivity (HR = 1.16, 95% CI: 1.14, 1.19 in males; HR = 1.18, 95% CI: 1.15, 1.20 in females), alcohol use (HR = 1.07, 95% CI: 1.06, 1.09 in males; HR = 1.09, 95% CI: 1.08, 1.11 in females), and BMI (HR = 1.03, 95% CI: 1.02, 1.04 in males; HR = 1.03, 95% CI: 1.02, 1.04 in females). Smoking, physical inactivity, alcohol use, and BMI mediated 29% (95% CI, 24%, 35%), 27% (95% CI, 22%, 33%), 12% (95% CI, 10%, 16%), and 5% (95% CI, 4%, 7%) of the inequalities in IHD mortality between low- and high-education males, respectively; the corresponding proportions mediated were 16% (95% CI, 11%, 23%), 26% (95% CI, 20%, 34%), 14% (95% CI, 11%, 19%), and 5% (95% CI, 3%, 7%) in females. Proportions mediated were slightly lower with family income used as the secondary indicator for SES. The main limitation of the methodology is that we could not rule out residual exposure-mediator, exposure-outcome, and mediator-outcome confounding. Conclusions In this study, BRFs explained more than half of the educational differences in IHD mortality, with some variations by sex. Public health interventions to reduce intermediate risk factors are crucial to reduce the socioeconomic disparities and burden of IHD mortality in the general US population.","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":"31 1","pages":""},"PeriodicalIF":15.8,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142253274","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}
Pub Date : 2024-09-17DOI: 10.1371/journal.pmed.1004467
Chris A Rees,Prashant Mahajan,Quique Bassat
{"title":"Is C-reactive protein sufficient to guide antimicrobial therapy for lower respiratory tract infections among children? Results from a stepped-wedge cluster randomized trial in Uganda.","authors":"Chris A Rees,Prashant Mahajan,Quique Bassat","doi":"10.1371/journal.pmed.1004467","DOIUrl":"https://doi.org/10.1371/journal.pmed.1004467","url":null,"abstract":"","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":"1 1","pages":"e1004467"},"PeriodicalIF":15.8,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142268892","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}
Pub Date : 2024-09-13DOI: 10.1371/journal.pmed.1004461
Joshua F. Ginnane, Samia Aziz, Saima Sultana, Connor Luke Allen, Annie McDougall, Katherine E. Eddy, Nick Scott, Joshua P. Vogel
Background Postpartum haemorrhage (PPH) is an obstetric emergency. While PPH-related deaths are relatively rare in high-resource settings, PPH continues to be the leading cause of maternal mortality in limited-resource settings. We undertook a systematic review to identify, assess, and synthesise cost-effectiveness evidence on postpartum interventions to prevent, diagnose, or treat PPH. Methods and findings This systematic review was prospectively registered on PROSPERO (CRD42023438424). We searched Medline, Embase, NHS Economic Evaluation Database (NHS EED), EconLit, CINAHL, Emcare, Web of Science, and Global Index Medicus between 22 June 2023 and 11 July 2024 with no date or language limitations. Full economic evaluations of any postpartum intervention for prevention, detection, or management of PPH were eligible. Study screening, data extraction, and quality assessments (using the CHEC-E tool) were undertaken independently by at least 2 reviewers. We developed narrative syntheses of available evidence for each intervention. From 3,993 citations, 56 studies were included: 33 studies of preventative interventions, 1 study assessed a diagnostic method, 17 studies of treatment interventions, 1 study comparing prevention and treatment, and 4 studies assessed care bundles. Twenty-four studies were conducted in high-income countries, 22 in upper or lower middle-income countries, 3 in low-income countries, and 7 studies involved countries of multiple income levels. Study settings, methods, and findings varied considerably. Interventions with the most consistent findings were the use of tranexamic acid for PPH treatment and using care bundles. In both cases, multiple studies predicted these interventions would either result in better health outcomes and cost savings, or better health outcomes at acceptable costs. Limitations for this review include that no ideal setting was chosen, and therefore, a transferability assessment was not undertaken. In addition, some sources of study uncertainty, such as effectiveness parameters, were interrogated to a greater degree than other sources of uncertainty. Conclusions In this systematic review, we extracted, critically appraised, and summarised the cost-effectiveness evidence from 56 studies across 16 different interventions for the prevention, diagnosis, and treatment of PPH. Both the use of tranexamic acid as part of PPH treatment, and the use of comprehensive PPH bundles for prevention, diagnosis, and treatment have supportive cost-effectiveness evidence across a range of settings. More studies utilizing best practice principles are required to make stronger conclusions on which interventions provide the best value. Several high-priority interventions recommended by World Health Organization (WHO) such as administering additional uterotonics, non-pneumatic anti-shock garment, or uterine balloon tamponade (UBT) for PPH management require robust economic evaluations across high-, middle-, and low-resource setti
{"title":"The cost-effectiveness of preventing, diagnosing, and treating postpartum haemorrhage: A systematic review of economic evaluations","authors":"Joshua F. Ginnane, Samia Aziz, Saima Sultana, Connor Luke Allen, Annie McDougall, Katherine E. Eddy, Nick Scott, Joshua P. Vogel","doi":"10.1371/journal.pmed.1004461","DOIUrl":"https://doi.org/10.1371/journal.pmed.1004461","url":null,"abstract":"Background Postpartum haemorrhage (PPH) is an obstetric emergency. While PPH-related deaths are relatively rare in high-resource settings, PPH continues to be the leading cause of maternal mortality in limited-resource settings. We undertook a systematic review to identify, assess, and synthesise cost-effectiveness evidence on postpartum interventions to prevent, diagnose, or treat PPH. Methods and findings This systematic review was prospectively registered on PROSPERO (CRD42023438424). We searched Medline, Embase, NHS Economic Evaluation Database (NHS EED), EconLit, CINAHL, Emcare, Web of Science, and Global Index Medicus between 22 June 2023 and 11 July 2024 with no date or language limitations. Full economic evaluations of any postpartum intervention for prevention, detection, or management of PPH were eligible. Study screening, data extraction, and quality assessments (using the CHEC-E tool) were undertaken independently by at least 2 reviewers. We developed narrative syntheses of available evidence for each intervention. From 3,993 citations, 56 studies were included: 33 studies of preventative interventions, 1 study assessed a diagnostic method, 17 studies of treatment interventions, 1 study comparing prevention and treatment, and 4 studies assessed care bundles. Twenty-four studies were conducted in high-income countries, 22 in upper or lower middle-income countries, 3 in low-income countries, and 7 studies involved countries of multiple income levels. Study settings, methods, and findings varied considerably. Interventions with the most consistent findings were the use of tranexamic acid for PPH treatment and using care bundles. In both cases, multiple studies predicted these interventions would either result in better health outcomes and cost savings, or better health outcomes at acceptable costs. Limitations for this review include that no ideal setting was chosen, and therefore, a transferability assessment was not undertaken. In addition, some sources of study uncertainty, such as effectiveness parameters, were interrogated to a greater degree than other sources of uncertainty. Conclusions In this systematic review, we extracted, critically appraised, and summarised the cost-effectiveness evidence from 56 studies across 16 different interventions for the prevention, diagnosis, and treatment of PPH. Both the use of tranexamic acid as part of PPH treatment, and the use of comprehensive PPH bundles for prevention, diagnosis, and treatment have supportive cost-effectiveness evidence across a range of settings. More studies utilizing best practice principles are required to make stronger conclusions on which interventions provide the best value. Several high-priority interventions recommended by World Health Organization (WHO) such as administering additional uterotonics, non-pneumatic anti-shock garment, or uterine balloon tamponade (UBT) for PPH management require robust economic evaluations across high-, middle-, and low-resource setti","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":"4 1","pages":""},"PeriodicalIF":15.8,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142253270","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}
Pub Date : 2024-09-12DOI: 10.1371/journal.pmed.1004428
William H K Schilling,Mavuto Mukaka,James J Callery,Martin J Llewelyn,Cintia V Cruz,Mehul Dhorda,Thatsanun Ngernseng,Naomi Waithira,Maneerat Ekkapongpisit,James A Watson,Arjun Chandna,Erni J Nelwan,Raph L Hamers,Anthony Etyang,Mohammad Asim Beg,Samba Sow,William Yavo,Aurel Constant Allabi,Buddha Basnyat,Sanjib Kumar Sharma,Modupe Amofa-Sekyi,Paul Yonga,Amanda Adler,Prayoon Yuentrakul,Tanya Cope,Janjira Thaipadungpanit,Panuvit Rienpradub,Mallika Imwong,Mohammad Yazid Abdad,Stuart D Blacksell,Joel Tarning,Frejus Faustin Goudjo,Ange D Dossou,Abibatou Konaté-Touré,Serge-Brice Assi,Kra Ouffoué,Nasronudin Nasronudin,Brian Eka Rachman,Pradana Zaky Romadhon,Didi Darmahadi Dewanto,Made Oka Heryana,Theresia Novi,Ayodhia Pitaloka Pasaribu,Mutiara Mutiara,Miranda Putri Rahayu Nasution,Khairunnisa Khairunnisa,Fauzan Azima Dalimunthe,Eka Airlangga,Akmal Fahrezzy,Yanri Subronto,Nur Rahmi Ananda,Mutia Rahardjani,Atika Rimainar,Ruth Khadembu Lucinde,Molline Timbwa,Otieno Edwin Onyango,Clara Agutu,Samuel Akech,Mainga Hamaluba,Jairus Kipyego,Obadiah Ngachi,Fadima Cheick Haidara,Oumar Y Traoré,François Diarra,Basudha Khanal,Piyush Dahal,Suchita Shrestha,Samita Rijal,Youssouf Kabore,Eric Adehossi,Ousmane Guindo,Farah Naz Qamar,Abdul Momin Kazi,Charles J Woodrow,Steven Laird,Maina Cheeba,Helen Ayles,Phaik Yeong Cheah,Walter R J Taylor,Elizabeth M Batty,Kesinee Chotivanich,Sasithon Pukrittayakamee,Weerapong Phumratanaprapin,Lorenz von Seidlein,Arjen Dondorp,Nicholas P J Day,Nicholas J White,
BACKGROUNDHydroxychloroquine (HCQ) has proved ineffective in treating patients hospitalised with Coronavirus Disease 2019 (COVID-19), but uncertainty remains over its safety and efficacy in chemoprevention. Previous chemoprevention randomised controlled trials (RCTs) did not individually show benefit of HCQ against COVID-19 and, although meta-analysis did suggest clinical benefit, guidelines recommend against its use.METHODS AND FINDINGSHealthy adult participants from the healthcare setting, and later from the community, were enrolled in 26 centres in 11 countries to a double-blind, placebo-controlled, randomised trial of COVID-19 chemoprevention. HCQ was evaluated in Europe and Africa, and chloroquine (CQ) was evaluated in Asia, (both base equivalent of 155 mg once daily). The primary endpoint was symptomatic COVID-19, confirmed by PCR or seroconversion during the 3-month follow-up period. The secondary and tertiary endpoints were: asymptomatic laboratory-confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection; severity of COVID-19 symptoms; all-cause PCR-confirmed symptomatic acute respiratory illness (including SARS-CoV-2 infection); participant reported number of workdays lost; genetic and baseline biochemical markers associated with symptomatic COVID-19, respiratory illness and disease severity (not reported here); and health economic analyses of HCQ and CQ prophylaxis on costs and quality of life measures (not reported here). The primary and safety analyses were conducted in the intention-to-treat (ITT) population. Recruitment of 40,000 (20,000 HCQ arm, 20,000 CQ arm) participants was planned but was not possible because of protracted delays resulting from controversies over efficacy and adverse events with HCQ use, vaccine rollout in some countries, and other factors. Between 29 April 2020 and 10 March 2022, 4,652 participants (46% females) were enrolled (HCQ/CQ n = 2,320; placebo n = 2,332). The median (IQR) age was 29 (23 to 39) years. SARS-CoV-2 infections (symptomatic and asymptomatic) occurred in 1,071 (23%) participants. For the primary endpoint the incidence of symptomatic COVID-19 was 240/2,320 in the HCQ/CQ versus 284/2,332 in the placebo arms (risk ratio (RR) 0.85 [95% confidence interval, 0.72 to 1.00; p = 0.05]). For the secondary and tertiary outcomes asymptomatic SARS-CoV-2 infections occurred in 11.5% of HCQ/CQ recipients and 12.0% of placebo recipients: RR: 0.96 (95% CI, 0.82 to 1.12; p = 0.6). There were no differences in the severity of symptoms between the groups and no severe illnesses. HCQ/CQ chemoprevention was associated with fewer PCR-confirmed all-cause respiratory infections (predominantly SARS-CoV-2): RR 0.61 (95% CI, 0.42 to 0.88; p = 0.009) and fewer days lost to work because of illness: 104 days per 1,000 participants over 90 days (95% CI, 12 to 199 days; p < 0.001). The prespecified meta-analysis of all published pre-exposure RCTs indicates that HCQ/CQ prophylaxis provided a moderate
{"title":"Evaluation of hydroxychloroquine or chloroquine for the prevention of COVID-19 (COPCOV): A double-blind, randomised, placebo-controlled trial.","authors":"William H K Schilling,Mavuto Mukaka,James J Callery,Martin J Llewelyn,Cintia V Cruz,Mehul Dhorda,Thatsanun Ngernseng,Naomi Waithira,Maneerat Ekkapongpisit,James A Watson,Arjun Chandna,Erni J Nelwan,Raph L Hamers,Anthony Etyang,Mohammad Asim Beg,Samba Sow,William Yavo,Aurel Constant Allabi,Buddha Basnyat,Sanjib Kumar Sharma,Modupe Amofa-Sekyi,Paul Yonga,Amanda Adler,Prayoon Yuentrakul,Tanya Cope,Janjira Thaipadungpanit,Panuvit Rienpradub,Mallika Imwong,Mohammad Yazid Abdad,Stuart D Blacksell,Joel Tarning,Frejus Faustin Goudjo,Ange D Dossou,Abibatou Konaté-Touré,Serge-Brice Assi,Kra Ouffoué,Nasronudin Nasronudin,Brian Eka Rachman,Pradana Zaky Romadhon,Didi Darmahadi Dewanto,Made Oka Heryana,Theresia Novi,Ayodhia Pitaloka Pasaribu,Mutiara Mutiara,Miranda Putri Rahayu Nasution,Khairunnisa Khairunnisa,Fauzan Azima Dalimunthe,Eka Airlangga,Akmal Fahrezzy,Yanri Subronto,Nur Rahmi Ananda,Mutia Rahardjani,Atika Rimainar,Ruth Khadembu Lucinde,Molline Timbwa,Otieno Edwin Onyango,Clara Agutu,Samuel Akech,Mainga Hamaluba,Jairus Kipyego,Obadiah Ngachi,Fadima Cheick Haidara,Oumar Y Traoré,François Diarra,Basudha Khanal,Piyush Dahal,Suchita Shrestha,Samita Rijal,Youssouf Kabore,Eric Adehossi,Ousmane Guindo,Farah Naz Qamar,Abdul Momin Kazi,Charles J Woodrow,Steven Laird,Maina Cheeba,Helen Ayles,Phaik Yeong Cheah,Walter R J Taylor,Elizabeth M Batty,Kesinee Chotivanich,Sasithon Pukrittayakamee,Weerapong Phumratanaprapin,Lorenz von Seidlein,Arjen Dondorp,Nicholas P J Day,Nicholas J White,","doi":"10.1371/journal.pmed.1004428","DOIUrl":"https://doi.org/10.1371/journal.pmed.1004428","url":null,"abstract":"BACKGROUNDHydroxychloroquine (HCQ) has proved ineffective in treating patients hospitalised with Coronavirus Disease 2019 (COVID-19), but uncertainty remains over its safety and efficacy in chemoprevention. Previous chemoprevention randomised controlled trials (RCTs) did not individually show benefit of HCQ against COVID-19 and, although meta-analysis did suggest clinical benefit, guidelines recommend against its use.METHODS AND FINDINGSHealthy adult participants from the healthcare setting, and later from the community, were enrolled in 26 centres in 11 countries to a double-blind, placebo-controlled, randomised trial of COVID-19 chemoprevention. HCQ was evaluated in Europe and Africa, and chloroquine (CQ) was evaluated in Asia, (both base equivalent of 155 mg once daily). The primary endpoint was symptomatic COVID-19, confirmed by PCR or seroconversion during the 3-month follow-up period. The secondary and tertiary endpoints were: asymptomatic laboratory-confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection; severity of COVID-19 symptoms; all-cause PCR-confirmed symptomatic acute respiratory illness (including SARS-CoV-2 infection); participant reported number of workdays lost; genetic and baseline biochemical markers associated with symptomatic COVID-19, respiratory illness and disease severity (not reported here); and health economic analyses of HCQ and CQ prophylaxis on costs and quality of life measures (not reported here). The primary and safety analyses were conducted in the intention-to-treat (ITT) population. Recruitment of 40,000 (20,000 HCQ arm, 20,000 CQ arm) participants was planned but was not possible because of protracted delays resulting from controversies over efficacy and adverse events with HCQ use, vaccine rollout in some countries, and other factors. Between 29 April 2020 and 10 March 2022, 4,652 participants (46% females) were enrolled (HCQ/CQ n = 2,320; placebo n = 2,332). The median (IQR) age was 29 (23 to 39) years. SARS-CoV-2 infections (symptomatic and asymptomatic) occurred in 1,071 (23%) participants. For the primary endpoint the incidence of symptomatic COVID-19 was 240/2,320 in the HCQ/CQ versus 284/2,332 in the placebo arms (risk ratio (RR) 0.85 [95% confidence interval, 0.72 to 1.00; p = 0.05]). For the secondary and tertiary outcomes asymptomatic SARS-CoV-2 infections occurred in 11.5% of HCQ/CQ recipients and 12.0% of placebo recipients: RR: 0.96 (95% CI, 0.82 to 1.12; p = 0.6). There were no differences in the severity of symptoms between the groups and no severe illnesses. HCQ/CQ chemoprevention was associated with fewer PCR-confirmed all-cause respiratory infections (predominantly SARS-CoV-2): RR 0.61 (95% CI, 0.42 to 0.88; p = 0.009) and fewer days lost to work because of illness: 104 days per 1,000 participants over 90 days (95% CI, 12 to 199 days; p < 0.001). The prespecified meta-analysis of all published pre-exposure RCTs indicates that HCQ/CQ prophylaxis provided a moderate ","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":"39 1","pages":"e1004428"},"PeriodicalIF":15.8,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142253271","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}
Pub Date : 2024-09-10DOI: 10.1371/journal.pmed.1004445
Timothy J. Fowler, Nicholas R. Howells, Ashley W. Blom, Adrian Sayers, Michael R. Whitehouse
Background Unicompartmental knee replacements (UKRs) are performed by surgeons at various stages in training with varying levels of supervision, but we do not know if this is a safe practice with comparable outcomes to consultant-performed UKR. The aim of this study was to use registry data for England and Wales to investigate the association between surgeon grade (consultant, or trainee), the senior supervision of trainees (supervised by a scrubbed consultant, or not), and the risk of revision surgery following UKR. Methods and findings We conducted an observational study using prospectively collected data from the National Joint Registry for England and Wales (NJR). We included adult patients who underwent primary UKR for osteoarthritis (n = 106,206), recorded in the NJR between 2003 and 2019. Exposures were the grade of the operating surgeon (consultant, or trainee) and whether or not trainees were directly supervised by a consultant during the procedure (referred to as “supervised by a scrubbed consultant”). The primary outcome was all-cause revision surgery. The secondary outcome was the number of procedures revised for the following specific indications: aseptic loosening/lysis, infection, progression of osteoarthritis, unexplained pain, and instability. Flexible parametric survival models were adjusted for patient, operation, and healthcare setting factors. We included 106,206 UKRs in 91,626 patients, of which 4,382 (4.1%) procedures were performed by a trainee. The unadjusted cumulative probability of failure at 15 years was 17.13% (95% CI [16.44, 17.85]) for consultants, 16.42% (95% CI [14.09, 19.08]) for trainees overall, 15.98% (95% CI [13.36, 19.07]) for trainees supervised by a scrubbed consultant, and 17.32% (95% CI [13.24, 22.50]) for trainees not supervised by a scrubbed consultant. There was no association between surgeon grade and all-cause revision in either crude or adjusted models (adjusted HR = 1.01, 95% CI [0.90, 1.13]; p = 0.88). Trainees achieved comparable all-cause survival to consultants, regardless of the level of scrubbed consultant supervision (supervised: adjusted HR = 0.99, 95% CI [0.87, 1.14]; p = 0.94; unsupervised: adjusted HR = 1.03, 95% CI [0.87, 1.22]; p = 0.74). Limitations of this study relate to its observational design and include: the potential for nonrandom allocation of cases by consultants to trainees; residual confounding; and the use of the binary variable “surgeon grade,” which does not capture variations in the level of experience between trainees. Conclusions This nationwide study of UKRs with over 16 years’ follow up demonstrates that trainees within the current training system in England and Wales achieve comparable all-cause implant survival to consultants. These findings support the current methods by which surgeons in England and Wales are trained to perform UKR.
背景 单间室膝关节置换术（UKR）是由处于不同培训阶段的外科医生在不同程度的监督下完成的，但我们不知道这种做法是否安全，其结果是否与由顾问完成的 UKR 相当。本研究的目的是利用英格兰和威尔士的登记数据，调查外科医生级别（顾问或受训者）、受训者的高级监督（是否由主治顾问监督）与UKR术后翻修手术风险之间的关系。方法和结果 我们利用英格兰和威尔士国家关节登记处（NJR）前瞻性收集的数据开展了一项观察性研究。我们纳入了 2003 年至 2019 年期间在 NJR 中记录的因骨关节炎接受初级 UKR 的成年患者（n = 106,206 人）。暴露因素包括手术外科医生的级别（顾问或受训人员）以及受训人员在手术过程中是否由顾问直接监督（简称为 "由一名负责手术的顾问监督"）。主要结果是所有原因导致的翻修手术。次要结果是因以下特定适应症进行翻修手术的数量：无菌性松动/溶解、感染、骨关节炎进展、原因不明的疼痛和不稳定性。灵活的参数生存模型根据患者、手术和医疗环境因素进行了调整。我们纳入了 91626 名患者的 106206 例 UKR，其中 4382 例（4.1%）由受训者实施。15年后未经调整的累积失败概率为：顾问 17.13% (95% CI [16.44, 17.85])；受训人员总体 16.42% (95% CI [14.09, 19.08])；受训人员在一名主治医师监督下的失败概率为 15.98% (95% CI [13.36, 19.07])；未受主治医师监督的受训人员失败概率为 17.32% (95% CI [13.24, 22.50])。在粗略模型或调整模型中，外科医生级别与全因改建之间均无关联（调整后 HR = 1.01，95% CI [0.90，1.13]；P = 0.88）。受训者的全因生存率与顾问相当，而与顾问的监督水平无关（有监督：调整后 HR = 0.99，95% CI [0.87，1.14]；p = 0.94；无监督：调整后 HR = 1.03，95% CI [0.87，1.22]；p = 0.74）。本研究的局限性与其观察性设计有关，包括：顾问将病例随机分配给受训者的可能性；残余混杂因素；使用二元变量 "外科医生级别"，无法反映受训者之间经验水平的差异。结论 这项对英国牙科手术进行了超过16年随访的全国性研究表明，在英格兰和威尔士目前的培训体系中，受训者的全因植入存活率与顾问相当。这些研究结果支持英格兰和威尔士目前对外科医生进行 UKR 培训的方法。
{"title":"Association between surgeon training grade and the risk of revision following unicompartmental knee replacement: An analysis of National Joint Registry data","authors":"Timothy J. Fowler, Nicholas R. Howells, Ashley W. Blom, Adrian Sayers, Michael R. Whitehouse","doi":"10.1371/journal.pmed.1004445","DOIUrl":"https://doi.org/10.1371/journal.pmed.1004445","url":null,"abstract":"Background Unicompartmental knee replacements (UKRs) are performed by surgeons at various stages in training with varying levels of supervision, but we do not know if this is a safe practice with comparable outcomes to consultant-performed UKR. The aim of this study was to use registry data for England and Wales to investigate the association between surgeon grade (consultant, or trainee), the senior supervision of trainees (supervised by a scrubbed consultant, or not), and the risk of revision surgery following UKR. Methods and findings We conducted an observational study using prospectively collected data from the National Joint Registry for England and Wales (NJR). We included adult patients who underwent primary UKR for osteoarthritis (<jats:italic>n</jats:italic> = 106,206), recorded in the NJR between 2003 and 2019. Exposures were the grade of the operating surgeon (consultant, or trainee) and whether or not trainees were directly supervised by a consultant during the procedure (referred to as “supervised by a scrubbed consultant”). The primary outcome was all-cause revision surgery. The secondary outcome was the number of procedures revised for the following specific indications: aseptic loosening/lysis, infection, progression of osteoarthritis, unexplained pain, and instability. Flexible parametric survival models were adjusted for patient, operation, and healthcare setting factors. We included 106,206 UKRs in 91,626 patients, of which 4,382 (4.1%) procedures were performed by a trainee. The unadjusted cumulative probability of failure at 15 years was 17.13% (95% CI [16.44, 17.85]) for consultants, 16.42% (95% CI [14.09, 19.08]) for trainees overall, 15.98% (95% CI [13.36, 19.07]) for trainees supervised by a scrubbed consultant, and 17.32% (95% CI [13.24, 22.50]) for trainees not supervised by a scrubbed consultant. There was no association between surgeon grade and all-cause revision in either crude or adjusted models (adjusted HR = 1.01, 95% CI [0.90, 1.13]; <jats:italic>p</jats:italic> = 0.88). Trainees achieved comparable all-cause survival to consultants, regardless of the level of scrubbed consultant supervision (supervised: adjusted HR = 0.99, 95% CI [0.87, 1.14]; <jats:italic>p</jats:italic> = 0.94; unsupervised: adjusted HR = 1.03, 95% CI [0.87, 1.22]; <jats:italic>p</jats:italic> = 0.74). Limitations of this study relate to its observational design and include: the potential for nonrandom allocation of cases by consultants to trainees; residual confounding; and the use of the binary variable “surgeon grade,” which does not capture variations in the level of experience between trainees. Conclusions This nationwide study of UKRs with over 16 years’ follow up demonstrates that trainees within the current training system in England and Wales achieve comparable all-cause implant survival to consultants. These findings support the current methods by which surgeons in England and Wales are trained to perform UKR.","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":"45 1","pages":""},"PeriodicalIF":15.8,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142226700","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}
Pub Date : 2024-09-10DOI: 10.1371/journal.pmed.1004450
Zoë Bell, Giang Nguyen, Gemma Andreae, Stephanie Scott, Letitia Sermin-Reed, Amelia A. Lake, Nicola Heslehurst
Background Maternal nutrition is crucial for health in pregnancy and across the generations. Experiencing food insecurity during pregnancy is a driver of inequalities in maternal diet with potential maternal and infant health consequences. This systematic review explored associations between food insecurity in pregnancy and maternal and infant health outcomes. Methods and findings Searches included 8 databases (MEDLINE, Embase, Scopus, Web of Science, PsychInfo, ASSIA, SSPC in ProQuest, and CINAHL), grey literature, forwards and backwards citation chaining, and contacting authors. Studies in high-income countries (HICs) reporting data on food insecurity in pregnancy and maternal or infant health, from January 1, 2008 to November 21, 2023 were included. Screening, data extraction, and quality assessment were carried out independently in duplicate. Random effects meta-analysis was performed when data were suitable for pooling, otherwise narrative synthesis was conducted. The protocol was registered on PROSPERO (CRD42022311669), reported with PRISMA checklist (S1 File). Searches identified 24,223 results and 25 studies (<jats:italic>n</jats:italic> = 93,871 women) were included: 23 from North America and 2 from Europe. Meta-analysis showed that food insecurity was associated with high stress level (OR 4.07, 95% CI [1.22, 13.55], <jats:italic>I</jats:italic><jats:sup><jats:italic>2</jats:italic></jats:sup> 96.40%), mood disorder (OR 2.53, 95% CI [1.46, 4.39], <jats:italic>I</jats:italic><jats:sup><jats:italic>2</jats:italic></jats:sup> 55.62%), gestational diabetes (OR 1.64, 95% CI [1.37, 1.95], <jats:italic>I</jats:italic><jats:sup><jats:italic>2</jats:italic></jats:sup> 0.00%), but not cesarean delivery (OR 1.42, 95% CI [0.78, 2.60], <jats:italic>I</jats:italic><jats:sup><jats:italic>2</jats:italic></jats:sup> 56.35%), birth weight (MD −58.26 g, 95% CI [−128.02, 11.50], <jats:italic>I</jats:italic><jats:sup><jats:italic>2</jats:italic></jats:sup> 38.41%), small-for-gestational-age (OR 1.20, 95%, CI [0.88, 1.63], <jats:italic>I</jats:italic><jats:sup><jats:italic>2</jats:italic></jats:sup> 44.66%), large-for-gestational-age (OR 0.88, 95% CI [0.70, 1.12] <jats:italic>I</jats:italic><jats:sup><jats:italic>2</jats:italic></jats:sup> 11.93%), preterm delivery (OR 1.18, 95% CI [0.98, 1.42], <jats:italic>I</jats:italic><jats:sup><jats:italic>2</jats:italic></jats:sup> 0.00%), or neonatal intensive care (OR 2.01, 95% CI [0.85, 4.78], <jats:italic>I</jats:italic><jats:sup><jats:italic>2</jats:italic></jats:sup> 70.48%). Narrative synthesis showed food insecurity was significantly associated with dental problems, depression, anxiety, and maternal serum concentration of perfluoro-octane sulfonate. There were no significant associations with other organohalogen chemicals, assisted delivery, postpartum haemorrhage, hospital admissions, length of stay, congenital anomalies, or neonatal morbidity. Mixed associations were reported for preeclampsia, hypertension, a
背景 孕产妇营养对孕期和几代人的健康至关重要。孕期食物不安全是导致孕产妇饮食不平等的一个因素，并可能对母婴健康造成影响。本系统综述探讨了孕期食物不安全与母婴健康结果之间的关联。方法和结果 搜索范围包括 8 个数据库（MEDLINE、Embase、Scopus、Web of Science、PsychInfo、ASSIA、ProQuest 中的 SSPC 和 CINAHL）、灰色文献、正向和反向引文链以及联系作者。本研究纳入了高收入国家（HICs）在 2008 年 1 月 1 日至 2023 年 11 月 21 日期间报告妊娠期粮食不安全和母婴健康数据的研究。筛选、数据提取和质量评估均独立进行，一式两份。如果数据适合汇总，则进行随机效应荟萃分析，否则进行叙述性综合分析。研究方案已在 PROSPERO（CRD42022311669）上注册，并按照 PRISMA 检查表（S1 文件）进行了报告。搜索共发现 24,223 项结果，纳入了 25 项研究（n = 93,871 名女性）：其中 23 项来自北美，2 项来自欧洲。元分析表明，食物不安全与高压力水平（OR 4.07，95% CI [1.22，13.55]，I2 96.40%）、情绪障碍（OR 2.53，95% CI [1.46，4.39]，I2 55.62%）、妊娠糖尿病（OR 1.64，95% CI [1.37，1.95]，I2 0.00%），但不包括剖宫产（OR 1.42，95% CI [0.78，2.60]，I2 56.35%）、出生体重（MD -58.26 g，95% CI [-128.02, 11.50]，I2 38.41%）、小胎龄（OR 1.20，95% CI [0.88, 1.63]，I2 44.66%）、大胎龄（OR 0.88，95% CI [0.70，1.12] I2 11.93%）、早产（OR 1.18，95% CI [0.98，1.42]，I2 0.00%）或新生儿重症监护（OR 2.01，95% CI [0.85，4.78]，I2 70.48%）。叙述性综述显示，食物不安全与牙科问题、抑郁、焦虑和母体血清中全氟辛烷磺酸浓度有显著关联。与其他有机卤素化学品、助产、产后出血、入院、住院时间、先天性畸形或新生儿发病率无明显关联。先兆子痫、高血压和社区/复原力等方面存在混合关联。结论 孕产妇粮食不安全与一些不良妊娠结局有关，尤其是精神健康和妊娠糖尿病。大多数纳入的研究都是在北美（主要是美国）进行的，这凸显了其他地区的研究差距。有必要在其他高收入国家/地区开展进一步研究，以了解在不同情况下（如那些没有实施嵌入式干预措施的国家/地区）的这些关联，从而为政策和护理要求提供依据。
{"title":"Associations between food insecurity in high-income countries and pregnancy outcomes: A systematic review and meta-analysis","authors":"Zoë Bell, Giang Nguyen, Gemma Andreae, Stephanie Scott, Letitia Sermin-Reed, Amelia A. Lake, Nicola Heslehurst","doi":"10.1371/journal.pmed.1004450","DOIUrl":"https://doi.org/10.1371/journal.pmed.1004450","url":null,"abstract":"Background Maternal nutrition is crucial for health in pregnancy and across the generations. Experiencing food insecurity during pregnancy is a driver of inequalities in maternal diet with potential maternal and infant health consequences. This systematic review explored associations between food insecurity in pregnancy and maternal and infant health outcomes. Methods and findings Searches included 8 databases (MEDLINE, Embase, Scopus, Web of Science, PsychInfo, ASSIA, SSPC in ProQuest, and CINAHL), grey literature, forwards and backwards citation chaining, and contacting authors. Studies in high-income countries (HICs) reporting data on food insecurity in pregnancy and maternal or infant health, from January 1, 2008 to November 21, 2023 were included. Screening, data extraction, and quality assessment were carried out independently in duplicate. Random effects meta-analysis was performed when data were suitable for pooling, otherwise narrative synthesis was conducted. The protocol was registered on PROSPERO (CRD42022311669), reported with PRISMA checklist (S1 File). Searches identified 24,223 results and 25 studies (<jats:italic>n</jats:italic> = 93,871 women) were included: 23 from North America and 2 from Europe. Meta-analysis showed that food insecurity was associated with high stress level (OR 4.07, 95% CI [1.22, 13.55], <jats:italic>I</jats:italic><jats:sup><jats:italic>2</jats:italic></jats:sup> 96.40%), mood disorder (OR 2.53, 95% CI [1.46, 4.39], <jats:italic>I</jats:italic><jats:sup><jats:italic>2</jats:italic></jats:sup> 55.62%), gestational diabetes (OR 1.64, 95% CI [1.37, 1.95], <jats:italic>I</jats:italic><jats:sup><jats:italic>2</jats:italic></jats:sup> 0.00%), but not cesarean delivery (OR 1.42, 95% CI [0.78, 2.60], <jats:italic>I</jats:italic><jats:sup><jats:italic>2</jats:italic></jats:sup> 56.35%), birth weight (MD −58.26 g, 95% CI [−128.02, 11.50], <jats:italic>I</jats:italic><jats:sup><jats:italic>2</jats:italic></jats:sup> 38.41%), small-for-gestational-age (OR 1.20, 95%, CI [0.88, 1.63], <jats:italic>I</jats:italic><jats:sup><jats:italic>2</jats:italic></jats:sup> 44.66%), large-for-gestational-age (OR 0.88, 95% CI [0.70, 1.12] <jats:italic>I</jats:italic><jats:sup><jats:italic>2</jats:italic></jats:sup> 11.93%), preterm delivery (OR 1.18, 95% CI [0.98, 1.42], <jats:italic>I</jats:italic><jats:sup><jats:italic>2</jats:italic></jats:sup> 0.00%), or neonatal intensive care (OR 2.01, 95% CI [0.85, 4.78], <jats:italic>I</jats:italic><jats:sup><jats:italic>2</jats:italic></jats:sup> 70.48%). Narrative synthesis showed food insecurity was significantly associated with dental problems, depression, anxiety, and maternal serum concentration of perfluoro-octane sulfonate. There were no significant associations with other organohalogen chemicals, assisted delivery, postpartum haemorrhage, hospital admissions, length of stay, congenital anomalies, or neonatal morbidity. Mixed associations were reported for preeclampsia, hypertension, a","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":"27 1","pages":""},"PeriodicalIF":15.8,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142210725","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}
Pub Date : 2024-09-09DOI: 10.1371/journal.pmed.1004460
Sebastian Burchert,Mhd Salem Alkneme,Ammar Alsaod,Pim Cuijpers,Eva Heim,Jonas Hessling,Nadine Hosny,Marit Sijbrandij,Edith Van't Hof,Pieter Ventevogel,Christine Knaevelsrud,
BACKGROUNDDigital mental health interventions for smartphones, such as the World Health Organization (WHO) Step-by-Step (SbS) program, are potentially scalable solutions to improve access to mental health and psychosocial support in refugee populations. Our study objective was to evaluate the effectiveness of SbS as self-guided intervention with optional message-based contact-on-demand (COD) support on reducing psychological distress, functional impairment, symptoms of posttraumatic stress disorder (PTSD), and self-identified problems in a sample of Syrian refugees residing in Egypt.METHODS AND FINDINGSWe conducted a 2-arm pragmatic randomized controlled trial. A total of 538 Syrians residing in Egypt with elevated levels of psychological distress (Kessler Psychological Distress Scale; K10 > 15) and reduced psychosocial functioning (WHODAS 2.0 > 16) were randomized into SbS + CAU (N = 266) or CAU only (N = 272). Primary outcomes were psychological distress (Hopkins Symptom Checklist 25) and impaired functioning (WHO Disability Assessment Schedule 2.0) at 3-month follow-up. Secondary outcomes were symptoms of PTSD (PTSD Checklist for DSM-5 short form, PCL-5 short) and self-identified problems (Psychological Outcomes Profiles Scale, PSYCHLOPS). Intention-to-treat (ITT) analyses showed significant but small effects of condition on psychological distress (mean difference: -0.15; 95% CI: -0.28, -0.02; p = .02) and functioning (mean difference: -2.04; 95% CI: -3.87, -0.22; p = .02) at 3-month follow-up. There were no significant differences between groups on symptoms of PTSD and self-identified problems. Remission rates did not differ between conditions on any of the outcomes. COD was used by 9.4% of participants for a median of 1 contact per person. The main limitations are high intervention dropout and low utilization of COD support.CONCLUSIONSThe trial provides a real-world implementation case, showing small positive effects of a digital, potentially scalable and self-guided mental health intervention for Syrian refugees in Egypt in reducing psychological distress and improving overall functioning. Further user-centered adaptations are required to improve adherence and effectiveness while maintaining scalability.TRIAL REGISTRATIONGerman Register for Clinical Studies DRKS00023505.
{"title":"Effects of a self-guided digital mental health self-help intervention for Syrian refugees in Egypt: A pragmatic randomized controlled trial.","authors":"Sebastian Burchert,Mhd Salem Alkneme,Ammar Alsaod,Pim Cuijpers,Eva Heim,Jonas Hessling,Nadine Hosny,Marit Sijbrandij,Edith Van't Hof,Pieter Ventevogel,Christine Knaevelsrud,","doi":"10.1371/journal.pmed.1004460","DOIUrl":"https://doi.org/10.1371/journal.pmed.1004460","url":null,"abstract":"BACKGROUNDDigital mental health interventions for smartphones, such as the World Health Organization (WHO) Step-by-Step (SbS) program, are potentially scalable solutions to improve access to mental health and psychosocial support in refugee populations. Our study objective was to evaluate the effectiveness of SbS as self-guided intervention with optional message-based contact-on-demand (COD) support on reducing psychological distress, functional impairment, symptoms of posttraumatic stress disorder (PTSD), and self-identified problems in a sample of Syrian refugees residing in Egypt.METHODS AND FINDINGSWe conducted a 2-arm pragmatic randomized controlled trial. A total of 538 Syrians residing in Egypt with elevated levels of psychological distress (Kessler Psychological Distress Scale; K10 > 15) and reduced psychosocial functioning (WHODAS 2.0 > 16) were randomized into SbS + CAU (N = 266) or CAU only (N = 272). Primary outcomes were psychological distress (Hopkins Symptom Checklist 25) and impaired functioning (WHO Disability Assessment Schedule 2.0) at 3-month follow-up. Secondary outcomes were symptoms of PTSD (PTSD Checklist for DSM-5 short form, PCL-5 short) and self-identified problems (Psychological Outcomes Profiles Scale, PSYCHLOPS). Intention-to-treat (ITT) analyses showed significant but small effects of condition on psychological distress (mean difference: -0.15; 95% CI: -0.28, -0.02; p = .02) and functioning (mean difference: -2.04; 95% CI: -3.87, -0.22; p = .02) at 3-month follow-up. There were no significant differences between groups on symptoms of PTSD and self-identified problems. Remission rates did not differ between conditions on any of the outcomes. COD was used by 9.4% of participants for a median of 1 contact per person. The main limitations are high intervention dropout and low utilization of COD support.CONCLUSIONSThe trial provides a real-world implementation case, showing small positive effects of a digital, potentially scalable and self-guided mental health intervention for Syrian refugees in Egypt in reducing psychological distress and improving overall functioning. Further user-centered adaptations are required to improve adherence and effectiveness while maintaining scalability.TRIAL REGISTRATIONGerman Register for Clinical Studies DRKS00023505.","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":"44 1","pages":"e1004460"},"PeriodicalIF":15.8,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142210726","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}
Pub Date : 2022-12-13DOI: 10.1101/2022.12.12.22283340
C. Rodway, S. Ibrahim, J. Westhead, L. Bojanić, P. Turnbull, L. Appleby, Andy Bacon, Harriet Dale, K. Harrison, N. Kapur
Background: There are comparatively few international studies investigating suicide in military veterans and no recent UK studies. We aimed to investigate the rate, timing, and risk factors for suicide in personnel who left the UK Armed Forces (UKAF) over a 22-year period. Methods and findings: We conducted a retrospective cohort study of suicide in personnel who left the regular UKAF between 1996 and 2018 by linking national databases of discharged personnel and suicide deaths. Of the 458,058 individuals who left the UKAF, 1,086 (0.2%) died by suicide. The overall rate of suicide in veterans was not greater than the general population (SMR [95% CI] 94 [88-99]). However, suicide risk was two to four times higher in male and female veterans aged under 25 years than in the same age groups in the general population (age-specific mortality ratios ranging from 160 to 409). Male veterans aged 35 years and older were at reduced risk of suicide (age-specific mortality ratios 47 to 80). Male sex, Army service, discharge between the ages of 16 and 34 years, being untrained on discharge, and length of service under 10 years were associated with increased suicide risk. Factors associated with reduced risk included being married, a higher rank and deployment on combat operations. The rate of contact with specialist NHS mental health services (273/1,086, 25%) was lowest in the youngest age groups (10% for 16-19-year-olds; 23% for 20-24-year-olds). Conclusions: Suicide risk in veterans is not high but there are important differences according to age, with higher risk in young men and women. We found a number of factors which increased the risk of suicide but deployment was associated with reduced risk. Our focus should be on improving and maintaining access to mental health care and social supports for young service leavers, as well as implementing general suicide prevention measures for all veterans.
{"title":"Suicide after leaving the UK Armed Forces 1996–2018: A cohort study","authors":"C. Rodway, S. Ibrahim, J. Westhead, L. Bojanić, P. Turnbull, L. Appleby, Andy Bacon, Harriet Dale, K. Harrison, N. Kapur","doi":"10.1101/2022.12.12.22283340","DOIUrl":"https://doi.org/10.1101/2022.12.12.22283340","url":null,"abstract":"Background: There are comparatively few international studies investigating suicide in military veterans and no recent UK studies. We aimed to investigate the rate, timing, and risk factors for suicide in personnel who left the UK Armed Forces (UKAF) over a 22-year period. Methods and findings: We conducted a retrospective cohort study of suicide in personnel who left the regular UKAF between 1996 and 2018 by linking national databases of discharged personnel and suicide deaths. Of the 458,058 individuals who left the UKAF, 1,086 (0.2%) died by suicide. The overall rate of suicide in veterans was not greater than the general population (SMR [95% CI] 94 [88-99]). However, suicide risk was two to four times higher in male and female veterans aged under 25 years than in the same age groups in the general population (age-specific mortality ratios ranging from 160 to 409). Male veterans aged 35 years and older were at reduced risk of suicide (age-specific mortality ratios 47 to 80). Male sex, Army service, discharge between the ages of 16 and 34 years, being untrained on discharge, and length of service under 10 years were associated with increased suicide risk. Factors associated with reduced risk included being married, a higher rank and deployment on combat operations. The rate of contact with specialist NHS mental health services (273/1,086, 25%) was lowest in the youngest age groups (10% for 16-19-year-olds; 23% for 20-24-year-olds). Conclusions: Suicide risk in veterans is not high but there are important differences according to age, with higher risk in young men and women. We found a number of factors which increased the risk of suicide but deployment was associated with reduced risk. Our focus should be on improving and maintaining access to mental health care and social supports for young service leavers, as well as implementing general suicide prevention measures for all veterans.","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":"20 1","pages":""},"PeriodicalIF":15.8,"publicationDate":"2022-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44034833","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}
Pub Date : 2022-10-11eCollection Date: 2022-10-01DOI: 10.1371/journal.pmed.1004108
Abiodun Adanikin, Deborah A Lawlor, Jill P Pell, Scott M Nelson, Gordon C S Smith, Stamatina Iliodromiti
<p><strong>Background: </strong>Birthweight centiles beyond the traditional thresholds for small or large babies are associated with adverse perinatal outcomes but there is a paucity of data about the relationship between birthweight centiles and childhood development among children born from 37 weeks of gestation. This study aims to establish the association between birthweight centiles across the whole distribution and early childhood development among children born from 37 weeks of gestation.</p><p><strong>Methods and findings: </strong>This is a population-based cohort study of 686,284 singleton infants born from 37 weeks of gestation. The cohort was generated by linking pregnancy and delivery data from the Scottish Morbidity Records (2003 to 2015) and the child developmental assessment at age 2 to 3.5 years. The main outcomes were child's fine motor, gross motor, communication, and social developmental concerns measured with the Ages and Stages Questionnaires-3 (ASQ-3) and Ages and Stages Questionnaire: Social & Emotional-2 (ASQ:SE-2), and for a subset of children with additional specialist tools such as the Modified Checklist for Autism in Toddlers (M-CHAT) if the ASQ3/SE indicate these are necessary. The ASQ score for each domain was categorised as "concern" and "no concern." We used multivariate cubic regression splines to model the associations between birthweight centiles and early childhood developmental concerns. We used multivariate Poisson regression models, with cluster robust errors, to estimate the relative risks (RRs) of developmental concerns below and above the established thresholds. We adjusted for maternal age, early pregnancy body mass index (BMI), parity, year of delivery, gestational age at delivery, smoking history, substance misuse in pregnancy, alcohol intake, ethnicity, residential area deprivation index, maternal clinical conditions in pregnancy (such as diabetes and pre-eclampsia), induction of labour, and child's sex. Babies born from 37 weeks of gestation with birthweight below the 25th centile, compared to those between the 25th and 74th centile, were at higher risk of developmental concerns. Those born between the 10th and 24th centile had an RR of 1.07 (95% CI: 1.03 to 1.12, p < 0.001), between the 3rd and 9th centile had an RR: 1.18 (95% CI: 1.12 to 1.25, p < 0.001), and <3rd centile had an RR of 1.37 (95% CI: 1.24 to 1.50, p < 0.001). There was no substantial increase in the risk of early childhood developmental concerns for larger birthweight categories of 75th to 89th (RR: 1.01; 95% CI: 0.97 to 1.05; p = 0.56), 90th to 96th (RR: 0.99; 95% CI: 0.94 to 1.05; p = 0.86), and ≥97th centiles (RR: 1.04; 95% CI: 0.97 to 1.12; p = 0.27), referent to birthweight between 25th and 74th centile. The percentage of developmental concerns attributable to birthweight between the 10th and 24th centile was more than that of birthweight <3rd centile (p = 0.023) because this group includes more of the population. Approximately
{"title":"Association of birthweight centiles and early childhood development of singleton infants born from 37 weeks of gestation in Scotland: A population-based cohort study.","authors":"Abiodun Adanikin, Deborah A Lawlor, Jill P Pell, Scott M Nelson, Gordon C S Smith, Stamatina Iliodromiti","doi":"10.1371/journal.pmed.1004108","DOIUrl":"https://doi.org/10.1371/journal.pmed.1004108","url":null,"abstract":"<p><strong>Background: </strong>Birthweight centiles beyond the traditional thresholds for small or large babies are associated with adverse perinatal outcomes but there is a paucity of data about the relationship between birthweight centiles and childhood development among children born from 37 weeks of gestation. This study aims to establish the association between birthweight centiles across the whole distribution and early childhood development among children born from 37 weeks of gestation.</p><p><strong>Methods and findings: </strong>This is a population-based cohort study of 686,284 singleton infants born from 37 weeks of gestation. The cohort was generated by linking pregnancy and delivery data from the Scottish Morbidity Records (2003 to 2015) and the child developmental assessment at age 2 to 3.5 years. The main outcomes were child's fine motor, gross motor, communication, and social developmental concerns measured with the Ages and Stages Questionnaires-3 (ASQ-3) and Ages and Stages Questionnaire: Social & Emotional-2 (ASQ:SE-2), and for a subset of children with additional specialist tools such as the Modified Checklist for Autism in Toddlers (M-CHAT) if the ASQ3/SE indicate these are necessary. The ASQ score for each domain was categorised as \"concern\" and \"no concern.\" We used multivariate cubic regression splines to model the associations between birthweight centiles and early childhood developmental concerns. We used multivariate Poisson regression models, with cluster robust errors, to estimate the relative risks (RRs) of developmental concerns below and above the established thresholds. We adjusted for maternal age, early pregnancy body mass index (BMI), parity, year of delivery, gestational age at delivery, smoking history, substance misuse in pregnancy, alcohol intake, ethnicity, residential area deprivation index, maternal clinical conditions in pregnancy (such as diabetes and pre-eclampsia), induction of labour, and child's sex. Babies born from 37 weeks of gestation with birthweight below the 25th centile, compared to those between the 25th and 74th centile, were at higher risk of developmental concerns. Those born between the 10th and 24th centile had an RR of 1.07 (95% CI: 1.03 to 1.12, p < 0.001), between the 3rd and 9th centile had an RR: 1.18 (95% CI: 1.12 to 1.25, p < 0.001), and <3rd centile had an RR of 1.37 (95% CI: 1.24 to 1.50, p < 0.001). There was no substantial increase in the risk of early childhood developmental concerns for larger birthweight categories of 75th to 89th (RR: 1.01; 95% CI: 0.97 to 1.05; p = 0.56), 90th to 96th (RR: 0.99; 95% CI: 0.94 to 1.05; p = 0.86), and ≥97th centiles (RR: 1.04; 95% CI: 0.97 to 1.12; p = 0.27), referent to birthweight between 25th and 74th centile. The percentage of developmental concerns attributable to birthweight between the 10th and 24th centile was more than that of birthweight <3rd centile (p = 0.023) because this group includes more of the population. Approximately","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":"19 10","pages":"e1004108"},"PeriodicalIF":15.8,"publicationDate":"2022-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9553050/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33500106","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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