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Hepatitis E vaccine and fetal loss: the potential pathophysiological basis - Authors' reply. 戊型肝炎疫苗与胎儿畸形:潜在的病理生理学基础 - 作者回复。
IF 34.3 1区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-11-01 DOI: 10.1016/s2214-109x(24)00412-1
Asma Binte Aziz,Susanne Dudman,Khalequ Zaman,John D Clemens
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引用次数: 0
Safety of hepatitis E vaccine in pregnancy: an emulated target trial following a mass reactive vaccination campaign in Bentiu internally displaced persons camp, South Sudan. 妊娠期戊型肝炎疫苗的安全性:南苏丹本提乌境内流离失所者营地大规模反应性疫苗接种活动后的模拟目标试验。
IF 34.3 1区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-11-01 DOI: 10.1016/s2214-109x(24)00321-8
Robin C Nesbitt,Andrew S Azman,Vincent Kinya Asilaza,Jessie K Edwards,Priscillah Gitahi,Patrick Nkemenang,Jetske Duncker,Melat Haile,Primitive Gakima,Joseph F Wamala,Fredrick Beden Loro,Duol Biem,Nelly Staderini,Manuel Albela,Monica Rull,John Rumunu,Iza Ciglenecki,Etienne Gignoux
BACKGROUNDEpidemic forms of hepatitis E cause high mortality among pregnant people, with case fatality risks over 30% and adverse fetal outcomes. In 2022, the first mass reactive vaccination campaign against hepatitis E was conducted in South Sudan with the HEV239 vaccine. We aimed to assess whether vaccination against hepatitis E in pregnancy increases the risk of fetal loss in a cohort of vaccinated and unvaccinated pregnant people.METHODSIn this emulated target trial, an exhaustive pregnancy census was conducted in Bentiu internally displaced persons camp after the second of three vaccination rounds. Women and girls aged 14-45 years with no current jaundice or acute illness were eligible for participation. Individuals who consented were revisited 28 days after their delivery date to document the pregnancy outcome. We used an emulated target trial framework to address biases inherent in observational studies. We matched vaccinated to unvaccinated participants on age, gestational age, and vaccination propensity score and estimated cumulative incidence functions for fetal loss in vaccinated compared to unvaccinated women in a competing risks framework using the Aalen-Johansen estimator.FINDINGSBetween May 16 and June 30, 2022, 3421 participants were enrolled and followed up for inclusion in analysis. Among 2741 women who had a pregnancy outcome after the start of the vaccination campaign, 67 (2·4%) were vaccinated before conception, 2036 (74·3%) were vaccinated during pregnancy, and 638 (23·2%) were not vaccinated. Among the 2407 women retained in the matched analyses, the cumulative risk of fetal loss among individuals vaccinated during pregnancy was 7·2% (95% CI 5·6-8·7) compared with 6·1% (3·7-9·2) among unvaccinated individuals, implying a risk ratio of 1·2 (95% CI 0·7-1·9).INTERPRETATIONNo evidence of increased risk of fetal loss was found among individuals vaccinated during pregnancy.FUNDINGMédecins Sans Frontières.
背景流行性戊型肝炎会导致孕妇高死亡率,病死率超过 30%,并对胎儿造成不良影响。2022 年,南苏丹开展了首次大规模戊型肝炎反应性疫苗接种活动,接种了 HEV239 疫苗。我们的目的是评估接种戊型肝炎疫苗是否会增加接种过疫苗和未接种过疫苗的孕妇的胎儿死亡风险。年龄在 14-45 岁之间、目前没有黄疸或急性疾病的妇女和女孩都有资格参加。在分娩日期 28 天后再次访问同意接种者,以记录妊娠结果。我们采用了模拟目标试验框架来解决观察性研究中固有的偏差。我们根据接种者的年龄、孕龄和接种倾向得分对接种者和未接种者进行了配对,并在竞争风险框架下使用 Aalen-Johansen 估计器估算了接种者和未接种者的胎儿丢失累积发生率函数。在疫苗接种活动开始后出现妊娠结果的 2741 名妇女中,67 人(2-4%)在受孕前接种了疫苗,2036 人(74-3%)在孕期接种了疫苗,638 人(23-2%)未接种疫苗。在配对分析中保留的 2407 名妇女中,孕期接种疫苗者的胎儿丢失累积风险为 7-2% (95% CI 5-6-8-7),而未接种者的胎儿丢失累积风险为 6-1% (3-7-9-2),这意味着风险比为 1-2 (95% CI 0-7-1-9)。
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引用次数: 0
Schistosome and malaria exposure and urban-rural differences in vaccine responses in Uganda: a causal mediation analysis using data from three linked randomised controlled trials. 乌干达血吸虫和疟疾暴露与疫苗反应的城乡差异:利用三项关联随机对照试验的数据进行因果中介分析。
IF 34.3 1区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-11-01 DOI: 10.1016/s2214-109x(24)00340-1
Agnes Natukunda,Gyaviira Nkurunungi,Ludoviko Zirimenya,Jacent Nassuuna,Christopher Zziwa,Caroline Ninsiima,Josephine Tumusiime,Ruth Nyanzi,Milly Namutebi,Fred Kiwudhu,Govert J van Dam,Paul L A M Corstjens,Robert Kizindo,Ronald Nkangi,Joyce Kabagenyi,Beatrice Nassanga,Stephen Cose,Anne Wajja,Pontiano Kaleebu,Alison M Elliott,Emily L Webb,
BACKGROUNDVaccine immunogenicity and effectiveness vary geographically. Chronic immunomodulating parasitic infections including schistosomes and malaria have been hypothesised to be mediators of geographical variations.METHODSWe compared vaccine-specific immune responses between three Ugandan settings (schistosome-endemic rural, malaria-endemic rural, and urban) and did causal mediation analysis to assess the role of Schistosoma mansoni and malaria exposure in observed differences. We used data from the control groups of three linked randomised trials investigating the effects of intensive parasite treatment among schoolchildren. All participants received the BCG vaccine (week 0); yellow fever (YF-17D), oral typhoid (Ty21a), human papillomavirus (HPV; week 4); and HPV booster and tetanus-diphtheria (week 28). Primary outcomes were vaccine responses at week 8 and, for tetanus-diphtheria, week 52. We estimated the total effect (TE) of setting on vaccine responses and natural indirect effect (NIE) mediated through current or previous infection with S mansoni or malaria, and baseline vaccine-specific responses.FINDINGSWe included 239 (43%) participants from the schistosomiasis-endemic setting, 171 (30%) from the malaria-endemic setting, and 151 (27%) from the urban setting. At week 8, vaccine responses were lower in rural settings: schistosomiasis-endemic versus urban settings (TE geometric mean ratio for YF-17D plaque reduction neutralisation at 50% (PRNT50) titres 0·58 [95% CI 0·37 to 0·91], for S Typhi O-lipopolysaccharide-specific IgG 0·61 [0·40 to 0·93], and for tetanus-specific IgG 0·33 [0·22 to 0·51]); malaria-endemic versus urban settings (YF-17D 0·70 [0·49 to 0·99], S Typhi O-lipopolysaccharide-specific IgG 0·29 [0·20 to 0·43], and tetanus-specific IgG 0·53 [-0·35 to 0·80]). However, we found higher BCG-specific IFNγ responses in the malaria-endemic versus urban setting (1·54 [1·20 to 1·98]). The estimated NIEs of setting on vaccine responses mediated through previous and current S mansoni and malaria were not statistically significant. For malaria-endemic versus urban settings, baseline vaccine-specific responses contributed to some but not all differences: S Typhi O-lipopolysaccharide-specific IgG at week 8 (57.9% mediated [38·6 to 77·2]) and week 52 (70·0% mediated [49·4 to 90·6]) and BCG at week 52 (46.4% mediated [-4·8 to 97·7]).INTERPRETATIONWe found significant variation in vaccine response between urban and rural settings but could not confirm a causal role for schistosome or malaria exposure. Other exposures require consideration.FUNDINGUK Medical Research Council.
背景疫苗的免疫原性和有效性因地域而异。我们比较了乌干达三种环境(血吸虫流行的农村地区、疟疾流行的农村地区和城市地区)的疫苗特异性免疫反应,并进行了因果中介分析,以评估曼氏血吸虫和疟疾暴露在观察到的差异中所起的作用。我们使用了三项关联随机试验的对照组数据,这些试验调查了强化寄生虫治疗对学龄儿童的影响。所有参与者都接种了卡介苗(第 0 周)、黄热病疫苗(YF-17D)、口服伤寒疫苗(Ty21a)、人类乳头瘤病毒疫苗(HPV;第 4 周)、HPV 加强剂和破伤风-白喉疫苗(第 28 周)。主要结果是第 8 周的疫苗反应,以及第 52 周破伤风-白喉的疫苗反应。我们估算了环境对疫苗应答的总效应(TE)、通过当前或既往感染过曼氏痢疾或疟疾以及基线疫苗特异性应答而产生的自然间接效应(NIE)。第 8 周时,农村地区的疫苗应答率较低:血吸虫病流行地区与城市地区相比(YF-17D 斑块减少中和 50%(PRNT50)滴度的 TE 几何平均比值为 0-58 [95% CI 0-37 至 0-91],伤寒杆菌 O 型脂多糖特异性 IgG 为 0-61 [0-40 至 0-93],破伤风特异性 IgG 为 0-33 [0-22 至 0-51]);疟疾流行区与城市环境(YF-17D 0-70 [0-49 to 0-99],伤寒杆菌 O 型脂多糖特异性 IgG 0-29 [0-20 to 0-43],破伤风特异性 IgG 0-53 [-0-35 to 0-80])。然而,我们发现疟疾流行地区的卡介苗特异性 IFNγ 反应高于城市地区(1-54 [1-20 to 1-98])。通过以前和现在的曼森氏杆菌和疟疾介导的环境对疫苗应答的估计NIEs在统计学上并不显著。对于疟疾流行地区与城市地区,疫苗特异性反应基线造成了一些差异,但并非所有差异:第 8 周(57.9%介导[38-6 至 77-2])和第 52 周(70-0%介导[49-4 至 90-6])的伤寒杆菌 O 型脂多糖特异性 IgG 和第 52 周的卡介苗(46.4%介导[-4-8 至 97-7])。需要考虑其他暴露因素。
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引用次数: 0
Rapid surveys on violence against women in crisis contexts: decision-making guidance based on the UN Women Rapid Gender Assessment surveys on violence against women during COVID-19. 危机背景下针对妇女暴力的快速调查:基于 COVID-19 期间联合国妇女署针对妇女暴力的快速性别评估调查的决策指南。
IF 34.3 1区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-11-01 DOI: 10.1016/s2214-109x(24)00278-x
Raphaëlle Rafin,Nabamallika Dehingia,Juncal Plazaola-Castaño,Anita Raj
Rapid surveys or assessments offer the possibility to collect data in contexts where classic data collection is not feasible (such as health, humanitarian, or climate crises) and when evidence-based urgent action is needed to mitigate the effects of the crisis. Until the past 5 years, rapid surveys were not widely used by practitioners, researchers, or policy makers to measure the effect of crises on violence against women due to a paucity of empirical evidence on their safety and likely utility in such contexts. In recent years, and particularly during the COVID-19 global pandemic, UN Women led the piloting and implementation of such surveys in various countries. We use our experiences from this work and other studies to offer concrete decision-making guidance-in the form of a checklist-for whether to conduct rapid surveys on violence against women in crisis contexts, with consideration of their value, risks, and the minimum safeguards needed to implement this type of work.
快速调查或评估提供了在传统数据收集不可行的情况下(如健康、人道主义或气候危机)以及需要采取循证紧急行动以减轻危机影响时收集数据的可能性。在过去 5 年之前,从业人员、研究人员或政策制定者并未广泛使用快速调查来衡量危机对暴力侵害妇女行为的影响,原因是缺乏有关快速调查在此类情况下的安全性和可能效用的经验证据。近年来,特别是在 COVID-19 全球大流行期间,联合国妇女署在多个国家领导了此类调查的试点和实施工作。我们利用从这项工作和其他研究中获得的经验,以核对表的形式为是否在危机背景下开展针对妇女暴力的快速调查提供具体的决策指导,同时考虑到其价值、风险以及开展此类工作所需的最低保障措施。
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引用次数: 0
Fixing the system to end violence against women. 修复系统,消除对妇女的暴力行为。
IF 34.3 1区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-11-01 DOI: 10.1016/s2214-109x(24)00429-7
The Lancet Global Health
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引用次数: 0
The lifetime risk of maternal near miss morbidity in Asia, Africa, the Middle East, and Latin America: a cross-country systematic analysis. 亚洲、非洲、中东和拉丁美洲孕产妇近乎失误发病的终生风险:跨国系统分析。
IF 34.3 1区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-11-01 DOI: 10.1016/s2214-109x(24)00322-x
Ursula Gazeley,Antonino Polizzi,Julio Romero Prieto,José Manuel Aburto,Georges Reniers,Veronique Filippi
BACKGROUNDLife-threatening maternal near miss (MNM) morbidity can have long-term consequences for the physical, psychological, sexual, social, and economic wellbeing of female individuals. The lifetime risk of MNM (LTR-MNM) quantifies the probability that a female individual aged 15 years will have an MNM before age 50 years, given current mortality and fertility rates. We compare the LTR-MNM globally to reveal inequities in the cumulative burden of severe maternal morbidity across the reproductive life course.METHODSWe estimated the LTR-MNM for 40 countries with multifacility, regional, or national data on the prevalence of MNM morbidity measured using WHO or modified WHO criteria of organ dysfunction from 2010 onwards (Central and Southern Asia=6, Eastern and Southeastern Asia=9, Latin America and the Caribbean=10, Northern Africa and Western Asia=2, sub-Saharan Africa=13). We also calculated the lifetime risk of severe maternal outcome (LTR-SMO) as the lifetime risk of maternal death or MNM.FINDINGSThe LTR-MNM ranges from a 1 in 269 risk in Viet Nam (2010) to 1 in 6 in Guatemala (2016), whereas the LTR-SMO ranges from a 1 in 201 risk in Malaysia (2014) to 1 in 5 in Guatemala (2016). The LTR-MNM is a 1 in 20 risk or higher in nine countries, seven of which are in sub-Saharan Africa. The LTR-SMO is a 1 in 20 risk or higher in 11 countries, eight of which are in sub-Saharan Africa. The relative contribution of the LTR-MNM to the LTR-SMO ranges from 42% in Angola to 99% in Japan.INTERPRETATIONThere exist substantial global and regional disparities in the cumulative burden of severe maternal morbidity across the reproductive life course. The LTR-MNM is an important indicator to highlight the magnitude of inequalities in MNM morbidity, once accounting for obstetric risk, fertility rates, and mortality rates. The LTR-SMO can be used to highlight variation in the relative importance of morbidity to the overall burden of maternal ill-health across the female reproductive life course, given countries' stage in the obstetric transition. Both the LTR-MNM and LTR-SMO can serve as important indicators to advocate for further global commitment to end preventable maternal morbidity and mortality.FUNDINGUK Economic and Social Research Council, EU Horizon 2020 Marie Curie Fellowship, and Leverhulme Trust Large Centre Grant.
背景危及生命的孕产妇险情(MNM)发病率会对女性的生理、心理、性、社会和经济福祉造成长期影响。在当前死亡率和生育率的情况下,孕产妇死亡终生风险(LTR-MNM)量化了 15 岁女性在 50 岁之前发生孕产妇死亡的概率。我们对全球的 LTR-MNM 进行了比较,以揭示整个生育期严重孕产妇发病率累积负担的不平等。方法 我们估算了 40 个国家的 LTR-MNM,这些国家拥有多机构、地区或国家数据,说明 2010 年以来使用世界卫生组织或修改后的世界卫生组织器官功能障碍标准测量的 MNM 发病率(中亚和南亚=6,东亚和东南亚=9,拉丁美洲和加勒比海=10,北非和西亚=2,撒哈拉以南非洲=13)。我们还计算了终生严重孕产妇结局风险(LTR-SMO),即终生孕产妇死亡风险或产妇死亡风险。研究结果:终生严重孕产妇结局风险在越南为 269 分之一(2010 年),在危地马拉为六分之一(2016 年),而终生严重孕产妇结局风险在马来西亚为 201 分之一(2014 年),在危地马拉为五分之一(2016 年)。在 9 个国家,LTR-MNM 的风险为 20 分之 1 或更高,其中 7 个国家位于撒哈拉以南非洲。在 11 个国家中,LTR-SMO 的风险为 20 分之 1 或更高,其中 8 个国家位于撒哈拉以南非洲。LTR-MNM 对 LTR-SMO 的相对贡献率从安哥拉的 42% 到日本的 99% 不等。在考虑产科风险、生育率和死亡率后,LTR-MNM 是突显 MNM 发病率不平等程度的重要指标。考虑到各国的产科转型阶段,LTR-SMO 可用来突显在整个女性生育期内,发病率对孕产妇健康不良总体负担的相对重要性的差异。LTR-MNM 和 LTR-SMO 可作为重要指标,倡导全球进一步致力于消除可预防的孕产妇发病率和死亡率。
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引用次数: 0
Mechanisms and causes of death after abdominal surgery in low-income and middle-income countries: a secondary analysis of the FALCON trial. 低收入和中等收入国家腹部手术后死亡的机制和原因:FALCON 试验的二次分析。
IF 19.9 1区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-11-01 Epub Date: 2024-09-05 DOI: 10.1016/S2214-109X(24)00318-8
<p><strong>Background: </strong>Death after surgery is devasting for patients, families, and communities, but remains common in low-income and middle-income countries (LMICs). We aimed to use high-quality data from an existing global randomised trial to describe the causes and mechanisms of postoperative mortality in LMICs. To do so, we developed a novel framework, learning from both existing classification systems and emerging insights during data analysis.</p><p><strong>Methods: </strong>This study was a preplanned secondary analysis of the FALCON trial in 54 hospitals across seven LMICs (Benin, Ghana, India, Mexico, Nigeria, Rwanda, and South Africa). FALCON was a pragmatic, 2 × 2 factorial, randomised controlled trial that compared the effectiveness of two types of interventions for skin preparation (10% aqueous povidone-iodine vs 2% alcoholic chlorhexidine) and sutures (triclosan-coated vs uncoated). Patients who did not have surgery or were lost to follow-up were excluded (n=231). The primary outcomes of the present analysis were the mechanism and cause of death within 30-days of surgery, determined using a modified verbal autopsy strategy from serious adverse event reports. Factors associated with mortality were explored in a mixed-effects Cox proportional hazards model. The FALCON trial is registered with ClinicalTrials.gov, NCT03700749.</p><p><strong>Findings: </strong>This preplanned secondary analysis of the FALCON trial included 5558 patients who underwent abdominal surgery, of whom 4248 (76·4%) patients underwent surgery in tertiary, referral centres and 1310 (23·6%) underwent surgery in primary referral (ie, district or rural) hospitals. 3704 (66·7%) of 5558 surgeries were emergent. 306 (5·5%) of 5558 patients died within 30 days of surgery. 226 (74%) of 306 deaths were due to circulatory system failure, which included 173 (57%) deaths from sepsis and 29 (9%) deaths from hypovolaemic shock including bleeding. 47 (15%) deaths were due to respiratory failure. 60 (20%) of 306 patients died without a clear cause of death: 45 (15%) patients died with sepsis of unknown origin and 15 (5%) patients died of an unknown cause. 46 (15%) of 306 patients died within 24 h, 111 (36%) between 24 h and 72 h, 57 (19%) between >72 h and 168 h, and 92 (30%) more than 1 week after surgery. 248 (81%) of 306 patients died in hospital and 58 (19%) patients died out of hospital. The adjusted Cox regression model identified age (hazard ratio 1·01, 95% CI 1·01-1·02; p<0·0001), ASA grade III-V (4·93, 3·45-7·03; p<0·0001), presence of diabetes (1·47, 1·04-2·41; p=0·033), being an ex-smoker (1·59, 1·10-2·30; p=0·013), emergency surgery (2·08, 1·45-2·98; p<0·0001), cancer (1·98, 1·42-2·76; p<0·0001), and major surgery (3·94, 2·30-6·75; p<0·0001) as risk factors for postoperative mortality INTERPRETATION: Circulatory failure leads to most deaths after abdominal surgery, with sepsis accounting for almost two-thirds. Variability in timing of death highlights opportun
背景:手术后死亡对患者、家庭和社区都是巨大的打击,但在低收入和中等收入国家(LMICs)仍很常见。我们的目标是利用现有全球随机试验的高质量数据来描述低收入和中等收入国家术后死亡的原因和机制。为此,我们开发了一个新颖的框架,既借鉴了现有的分类系统,又在数据分析过程中获得了新的见解:本研究是对 FALCON 试验的一项预先计划的二次分析,该试验在 7 个低收入、中等收入国家/地区(贝宁、加纳、印度、墨西哥、尼日利亚、卢旺达和南非)的 54 家医院进行。FALCON 是一项务实的 2 × 2 因式随机对照试验,比较了两种备皮(10% 聚维酮碘水溶液与 2% 洗必泰酒精)和缝合(三氯生涂层与无涂层)干预措施的效果。未进行手术或失去随访的患者被排除在外(231 人)。本次分析的主要结果是手术后 30 天内的死亡机制和原因,根据严重不良事件报告采用改良的口头尸检策略确定。通过混合效应 Cox 比例危险模型探讨了与死亡率相关的因素。FALCON试验已在ClinicalTrials.gov上注册,编号为NCT03700749.研究结果:FALCON试验的这项预先计划的二次分析纳入了5558名接受腹部手术的患者,其中4248名(76-4%)患者在三级转诊中心接受了手术,1310名(23-6%)患者在一级转诊医院(即地区或农村医院)接受了手术。5558 例手术中有 3704 例(66-7%)为急诊手术。5558名患者中有306名(5-5%)在术后30天内死亡。306 例死亡病例中有 226 例(74%)死于循环系统衰竭,其中 173 例(57%)死于败血症,29 例(9%)死于低血容量休克,包括出血。47人(15%)死于呼吸衰竭。306 名患者中有 60 人(20%)死于无明确死因:45(15%)名患者死于原因不明的败血症,15(5%)名患者死因不明。306例患者中有46例(15%)在术后24小时内死亡,111例(36%)在术后24小时至72小时内死亡,57例(19%)在术后72小时以上至168小时内死亡,92例(30%)在术后1周以上死亡。306名患者中有248人(81%)死于住院,58人(19%)死于院外。调整后的 Cox 回归模型确定了年龄(危险比 1-01,95% CI 1-01-1-02;pFunding:国家健康与护理研究所全球健康研究组。
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引用次数: 0
Resolving the CD4-testing crisis to help end AIDS-related deaths. 解决 CD4 检测危机,帮助消除与艾滋病相关的死亡。
IF 19.9 1区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-10-30 DOI: 10.1016/S2214-109X(24)00444-3
Omar Syarif, Rita Oladele, Tinne Gils, Radha Rajasingham, Jonathan Falconer, Pamela Achii, Edna Tembo, Donald Denis Tobaiwa, Kenneth Mwehonge, Charlotte Schutz, Nelesh P Govender, Graeme Meintjes, David B Meya, Angela Loyse
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引用次数: 0
Africa's mpox strategic preparedness and response plan: a coordinated continental effort to boost health security. 非洲水痘战略准备和应对计划:非洲大陆协调努力,促进健康安全。
IF 19.9 1区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-10-29 DOI: 10.1016/S2214-109X(24)00464-9
Nicaise Ndembi, Ngashi Ngongo, Moréniké Oluwátóyìn Foláyan, Jean Marie Yameogo, Fiona Braka, Salam Abdou Gueye, Moeti Matshidiso, Jean Kaseya
{"title":"Africa's mpox strategic preparedness and response plan: a coordinated continental effort to boost health security.","authors":"Nicaise Ndembi, Ngashi Ngongo, Moréniké Oluwátóyìn Foláyan, Jean Marie Yameogo, Fiona Braka, Salam Abdou Gueye, Moeti Matshidiso, Jean Kaseya","doi":"10.1016/S2214-109X(24)00464-9","DOIUrl":"https://doi.org/10.1016/S2214-109X(24)00464-9","url":null,"abstract":"","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":" ","pages":""},"PeriodicalIF":19.9,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142564971","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
Effect of a participatory whole-systems approach on mortality in children younger than 5 years in Jigawa state, Nigeria (INSPIRING trial): a community-based, parallel-arm, pragmatic, cluster randomised controlled trial and concurrent mixed-methods process evaluation. 参与式全系统方法对尼日利亚吉加瓦州 5 岁以下儿童死亡率的影响(INSPIRING 试验):一项基于社区、平行臂、务实、群组随机对照试验和同时进行的混合方法过程评估。
IF 19.9 1区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-10-17 DOI: 10.1016/S2214-109X(24)00369-3
Carina King, Rochelle Ann Burgess, Ayobami A Bakare, Funmilayo Shittu, Julius Salako, Damola Bakare, Obioma C Uchendu, Agnese Iuliano, Nehla Djellouli, Adamu Isah, Ibrahim Haruna, Samy Ahmar, Tahlil Ahmed, Paula Valentine, Temitayo Folorunso Olowookere, Matthew MacCalla, Hamish R Graham, Eric D McCollum, James Beard, Adegoke G Falade, Tim Colbourn
<p><strong>Background: </strong>In 2019, Nigeria reported the highest mortality rate in children younger than 5 years globally. We aimed to assess a whole-systems approach to improving child mortality in northern Nigeria.</p><p><strong>Methods: </strong>We conducted a community-based, parallel-arm, pragmatic, cluster randomised controlled trial in Kiyawa local government area, Jigawa state, Nigeria, and a concurrent mixed-methods process evaluation using ethnography and quantitative implementation monitoring. Trial clusters were population catchment areas of 32 government primary health-care facilities. Compounds were randomly sampled, proportional to cluster size, and all women aged 16-49 years and children younger than 5 years who were permanent residents were eligible for inclusion and recruited as the evaluation population. Children younger than 7 days were recruited but excluded from analysis. Evaluation clusters were allocated to intervention or control via simple randomisation with a 1:1 ratio. Cluster names were written on paper, folded, and placed in a container by community representatives. Different community representatives took out names one by one, with the first half assigned to receive the intervention. The intervention consisted of three components: participatory learning and action (PLA) groups for men and women (including compound heads [ie, the member of the compound that residents deemed most senior]), partnership defined quality scorecard (PDQS), and health-care worker capacity building; it was delivered from March 1, 2021, to Dec 31, 2022. We could not mask participants, field staff, or intervention-delivery staff to cluster allocation but baseline, endline, and follow-up data excluded information on cluster allocation. PLA groups involved separate groups of up to 25 men or women from all villages in the intervention clusters. The primary outcome was all-cause mortality in children aged 7 days to 59 months between Oct 1, 2021, and Sept 20, 2022, referred to as the evaluation period. The trial was prospectively registered (ISRCTN 39213655) and the protocol has been published.</p><p><strong>Findings: </strong>We recruited 3800 compounds at baseline, with 12 893 children contributing to analysis of the primary outcome (7316 [56·8%] of 12 893 in the intervention group and 5577 [43·3%] in the control group). 6617 (51·3%) of 12 893 children were male, 6275 (48·7%) were female, and one (<0·1%) child had missing sex data. Sampled compounds randomly came from 388 (91·3%) of 425 villages in the 32 clusters. We conducted verbal autopsies for 1182 deaths, of which 369 (31·2%) were children aged 7 days to 59 months during the evaluation period. Of these 369, 91 (24·7%) were classified as pneumonia deaths. Children contributed a median 361 days (IQR 236-365) to the analysis, with 369 (2·9%) of 12 893 children censored on their date of death, 1545 (12·0%) on their 5th birthday, and 3392 (26·3%) on the date of the most recent follow-up in
背景:2019 年,尼日利亚 5 岁以下儿童死亡率居全球之首。我们旨在评估改善尼日利亚北部儿童死亡率的全系统方法:我们在尼日利亚吉加瓦州基亚瓦地方政府辖区开展了一项基于社区、平行臂、务实、分组随机对照试验,并同时采用人种学和定量实施监测进行了混合方法过程评估。试验群组是 32 个政府初级卫生保健设施的人口聚集区。根据群组大小按比例随机抽样,所有年龄在 16-49 岁之间的妇女和 5 岁以下的儿童,只要是常住居民,都有资格被纳入并被招募为评估人群。小于 7 天的儿童也被纳入其中,但不在分析之列。通过简单的随机分配,以 1:1 的比例将评估群组分配给干预组或对照组。社区代表将群组名称写在纸上,折叠后放入容器中。不同的社区代表逐个取出名字,前一半被分配接受干预。干预措施由三部分组成:男性和女性参与式学习与行动(PLA)小组(包括院落负责人[即院落中居民认为资历最深的成员])、伙伴关系定义的质量记分卡(PDQS)和医疗工作者能力建设;干预措施从 2021 年 3 月 1 日开始,至 2022 年 12 月 31 日结束。我们不能将参与者、现场工作人员或干预实施人员与分组分配相混淆,但基线、终点和随访数据不包括分组分配信息。PLA 小组包括来自干预群组中所有村庄的最多 25 名男性或女性组成的独立小组。主要研究结果是 2021 年 10 月 1 日至 2022 年 9 月 20 日期间 7 天至 59 个月儿童的全因死亡率,这段时间被称为评估期。该试验已进行了前瞻性注册(ISRCTN 39213655),试验方案也已公布:我们招募了3800名基线化合物,其中12 893名儿童参与了主要结果分析(干预组12 893名儿童中有7316名[56-8%],对照组5577名[43-3%])。在 12 893 名儿童中,6617 名(51-3%)为男性,6275 名(48-7%)为女性,1 名(解释:我们的干预措施没有影响死亡率:我们的干预措施没有影响死亡率。然而,由于该地区的儿童死亡率较高,应进一步努力调整我们的参与式全系统方法,在大院内使用行动社区:资助:葛兰素史克公司和英国救助儿童会:摘要的豪萨语译文见 "补充材料 "部分。
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