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Efficacy of daily versus intermittent oral iron supplementation for prevention of anaemia among pregnant women: a systematic review and meta-analysis. 预防孕妇贫血的每日口服铁质补充剂与间歇性口服铁质补充剂的功效:系统综述与荟萃分析。
IF 9.6 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-17 eCollection Date: 2024-08-01 DOI: 10.1016/j.eclinm.2024.102742
Anindita Banerjee, Shreyasi Athalye, Poonam Shingade, Vandana Khargekar, Namrata Mahajan, Manisha Madkaikar, Naveen Khargekar

Background: The World Health Organization recommends daily oral supplementation of iron for prevention of maternal anaemia. However, the adverse effects due to daily supplementation leads to poor compliance among pregnant women. Also, the mucosal block theory suggests that intermittent oral iron may be more efficient than daily iron with respect to optimum absorption. Our meta-analysis reviewed the existing clinical studies for the efficacy of daily versus intermittent oral iron supplementation.

Methods: In this systematic review and meta-analysis [PROSPERO ID:CRD42024498180], we searched PubMed, Google Scholar, Scopus, Science Direct and Cochrane database for studies published from 1st January 1970 to 31st December, 2023. Studies comparing daily and intermittent iron supplementation in pregnant women were included. The median intermittent iron dose was 120 mg/day and daily iron dose was 60 mg/day. The primary outcome was endpoint haemoglobin levels after iron supplementation. The data was analysed using the 'meta' and 'metafor' packages in RStudio using random effects model. The heterogeneity, publication bias, risk of bias and certainty of evidence were assessed using I2 statistics, funnel plots, Cochrane Risk of Bias 2 (ROB2) tool, and the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach respectively.

Findings: Of 4615 search results, 26 studies (n = 4365 participants) were included in this meta-analysis. There was no significant difference (p = 0.18) between the endpoint mean haemoglobin levels of the daily versus intermittent oral iron groups (standardized mean difference (SMD): 0.51, 95% CI: -0.23 to 1.24, I2 = 97%, low certainty evidence) irrespective of baseline anaemic status. However, the endpoint ferritin levels were significantly higher in the daily supplementation group (SMD: 0.85, 95% CI: 0.15-1.54, p = 0.02, I2 = 97%, low certainty evidence). The adjusted odds ratio for nausea, (adjusted odds ratio (OR) 3.56, 95% CI: 2.23-5.69, p < 0.001, I2 = 9%, moderate certainty evidence), diarrhoea (adjusted OR 5.40, 95% CI: 1.90-15.33, p = 0.002, I2 = 0%, low certainty evidence) and constipation (adjusted OR 1.95, 95% CI: 1.21-3.14, p = 0.006, I2 = 0%, moderate certainty evidence) was significantly higher in daily oral iron supplementation group.

Interpretation: Intermittent oral iron supplementation with a median dose of 120 mg/day demonstrates comparable efficacy to daily oral iron supplementation median dose of 60 mg/day in increasing haemoglobin levels among pregnant women with a significant reduction in adverse events.

Funding: There was no funding for this study.

背景:世界卫生组织建议每天口服铁剂以预防孕妇贫血。然而,由于每日补充铁剂会产生不良影响,导致孕妇对补充铁剂的依从性不高。此外,粘膜阻滞理论认为,间歇性口服铁剂可能比每日口服铁剂更有利于最佳吸收。我们的荟萃分析回顾了现有的关于每日口服铁剂与间歇性口服铁剂疗效的临床研究:在这项系统回顾和荟萃分析[PROSPERO ID:CRD42024498180]中,我们检索了 PubMed、Google Scholar、Scopus、Science Direct 和 Cochrane 数据库中 1970 年 1 月 1 日至 2023 年 12 月 31 日发表的研究。其中包括比较孕妇每日和间歇性补铁的研究。间歇性铁剂剂量的中位数为 120 毫克/天,每日铁剂剂量为 60 毫克/天。主要结果是补充铁剂后的终点血红蛋白水平。使用随机效应模型,使用 RStudio 中的 "meta "和 "metafor "软件包对数据进行了分析。分别使用 I2 统计量、漏斗图、Cochrane Risk of Bias 2(ROB2)工具和推荐、评估、发展和评价分级(GRADE)方法评估了异质性、发表偏倚、偏倚风险和证据的确定性:在 4615 项搜索结果中,有 26 项研究(n = 4365 名参与者)被纳入本次荟萃分析。无论基线贫血状态如何,每日口服铁剂组与间歇性口服铁剂组的终点平均血红蛋白水平无明显差异(p = 0.18)(标准化平均差异(SMD):0.51,95% CI:-0.23 至 1.24,I2 = 97%,证据确定性低)。然而,每日补充剂组的终点铁蛋白水平明显更高(SMD:0.85,95% CI:0.15-1.54,P = 0.02,I2 = 97%,低确定性证据)。恶心(调整后的几率比(OR)为 3.56,95% CI:2.23-5.69,p 2 = 9%,中等确定性证据)、腹泻(调整后的几率比(OR)为 5.40,95% CI:1.90-15.33,p = 0.002,I2 = 0%,低度确定性证据)和便秘(调整 OR 1.95,95% CI:1.21-3.14,p = 0.006,I2 = 0%,中度确定性证据)在每日口服铁补充剂组明显较高:在提高孕妇血红蛋白水平方面,中位剂量为 120 毫克/天的间歇性口服铁质补充剂与中位剂量为 60 毫克/天的每日口服铁质补充剂的疗效相当,且不良反应明显减少:本研究没有资金支持。
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引用次数: 0
Outpatient elective induction of labour at 39 weeks' gestation (HOME INDUCTION): an open-label, randomised, controlled, phase III, non-inferiority trial. 妊娠 39 周门诊选择性引产(HOME INDUCTION):一项开放标签、随机对照、III 期、非劣效试验。
IF 9.6 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-17 eCollection Date: 2024-08-01 DOI: 10.1016/j.eclinm.2024.102741
Sarah M Nicholson, Karen Flood, Patrick Dicker, Zara E Molphy, Orla T Smith, Corina I Oprescu, Eimear M Wall, Sara N El Nimr, Ita M Shanahan, Bernard J Kennedy, Ronan V Daly, Geraldine Gannon, Claudia Looi, Elena Fernandez, Fergal D Malone

Background: The increased demand for induction of labour (IOL) at 39 weeks' gestation in normal-risk nulliparous patients creates significant logistical challenges for busy maternity units. A potential innovation is commencing induction by means of outpatient cervical ripening, using either a vaginal prostaglandin preparation (Propess) or an osmotic cervical dilator (Dilapan-S).

Methods: A Phase III, open label, single centre non-inferiority trial (EudraCT number 2019-004697-25) randomised healthy nulliparous women who chose elective IOL at 39 weeks to one of three methods of initial cervical ripening, specifically 12 h of Dilapan-S(D12), 24 h of Dilapan-S(D24), or 24 h of Propess(P24) between November 2020 and July 2023. After initial administration of the IOL agent in the hospital, participants returned home for 12 or 24 h, before readmission to complete delivery. The primary outcome was vaginal delivery achieved at any time, and this was compared in a non-inferiority analysis of Dilapan-S compared to Propess, within a 10% non-inferiority margin. Secondary outcomes included pairwise comparisons for each induction agent, and a range of logistical factors, such as time to delivery, the need for an additional cervical ripening agent, and length of hospital stay.

Findings: Of the 327 women randomised at 38 weeks, 271 (83%) completed the induction intervention. The D24 and P24 groups showed similarly high rates of vaginal delivery, 75% and 76% respectively. D12 had a lower vaginal delivery rate of 64% and consequently the overall comparison of Dilapan-S to Propess did not demonstrate non-inferiority (difference = -6%, 95% CI = -17%, 5%) because the lower 95% CI exceeded the -10% threshold of non-inferiority. The majority of participants across all groups were delivered by any means within 72 h of starting the induction process, inclusive of time spent at home (89% of the D24 group, 98% of the D12 group, 95% of the P24 group). There were no differences in rates of adverse events between groups.

Interpretation: There were similarly high vaginal delivery rates for D24 and P24, with at least 75% of patients successfully delivering vaginally following outpatient cervical ripening, with no significant adverse maternal or neonatal outcomes.

Funding: The Rotunda Foundation, Medicem Technology s.r.o.

背景:正常风险的无产科病人在妊娠 39 周时进行引产(IOL)的需求增加,这给繁忙的产科带来了巨大的后勤挑战。一种潜在的创新方法是使用阴道前列腺素制剂(Propess)或渗透性宫颈扩张器(Dilapan-S),通过门诊宫颈成熟术开始引产:一项III期、开放标签、单中心非劣效性试验(EudraCT编号2019-004697-25)将39周时选择IOL的健康无阴道妇女随机分为三种初始宫颈成熟方法,即在2020年11月至2023年7月期间使用12小时Dilapan-S(D12)、24小时Dilapan-S(D24)或24小时Propess(P24)。在医院首次使用人工晶体植入剂后,参与者回家休息12或24小时,然后再次入院完成分娩。主要结果是在任何时间实现阴道分娩,在非劣效性分析中比较了Dilapan-S与Propess的非劣效性,非劣效性差值为10%。次要结果包括每种诱导剂的配对比较以及一系列后勤因素,如分娩时间、是否需要额外的宫颈成熟剂以及住院时间:在38周时随机抽取的327名产妇中,有271人(83%)完成了引产干预。D24 组和 P24 组的阴道分娩率同样很高,分别为 75% 和 76%。D12组的阴道分娩率较低,仅为64%,因此,Dilapan-S与Propess的总体比较未显示出非劣效性(差异=-6%,95% CI=-17%,5%),因为较低的95% CI超过了-10%的非劣效性阈值。所有组别中的大多数参与者都在诱导过程开始后 72 小时内以任何方式完成了分娩,包括在家度过的时间(D24 组 89%,D12 组 98%,P24 组 95%)。各组之间的不良事件发生率没有差异:D24组和P24组的阴道分娩率同样很高,至少有75%的患者在门诊宫颈成熟术后成功阴道分娩,且未出现明显的孕产妇或新生儿不良后果:罗通达基金会、Medicem Technology s.r.o.
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引用次数: 0
Associations of bisphenol and phthalate exposure and anti-Müllerian hormone levels in women of reproductive age. 育龄妇女接触双酚和邻苯二甲酸盐与抗苗勒氏管激素水平的关系。
IF 9.6 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-17 eCollection Date: 2024-08-01 DOI: 10.1016/j.eclinm.2024.102734
Sophia M Blaauwendraad, Ramon H M Dykgraaf, Romy Gaillard, Mengling Liu, Joop S Laven, Vincent W V Jaddoe, Leonardo Trasande

Background: In women, exposure to endocrine disrupting chemicals might accelerate the depletion of the ovarian reserve and might be associated with accelerative reproductive aging and fertility. We examined the longitudinal associations of exposure to bisphenols and phthalates with anti-Müllerian hormone concentrations.

Methods: Pregnant women of 18 years or older that resided in Rotterdam between 2002 and 2006 were eligible for participation in this longitudinal prospective cohort study. We measured urinary bisphenol and phthalate concentration at three time-points in pregnancy among 1405 women, of whom 1322 women had serum Anti-Müllerian Hormone (AMH) measurements 6 and/or 9 years postpartum. We performed linear regression models to assess the association of urinary bisphenol and phthalate metabolites with AMH after 6 and 9 years, and linear mixed-effect model to assess the association with AMH over time. Models were adjusted for sociodemographic and lifestyle factors.

Findings: In our multivariable linear regression models we observed associations of higher urinary pregnancy-averaged mono-isobutyl phthalate (mIBP), mono-(2-ethyl-5-oxohexyl) phthalate (mEOHP), and monobenzyl phthalate (mBzBP) with lower serum AMH after both 6 and 9 years. However, these associations did not remain after adjustment for multiple testing. No significant associations of bisphenol A with AMH were present in our study sample. In our linear mixed-effects models, higher mIBP, mono-(2-ethyl-5-hydroxyhexyl) phthalate (mEHHP), mEOHP, and mBzBP were associated with lower overall AMH levels (differences -0.07 (95% CI -0.13, -0.02), -0.09 (-0.15, -0.02), -0.08 (95% CI -0.14, -0.02), and -0.08 (-0.13, -0.03) μg/L per doubling in mIBP, mEHHP, mEOHP, and mBzBP respectively) (all False Discovery Rate adjusted p-values < 0.05).

Interpretation: We identify decreases in indices of ovarian reserve in relationship to prenatal phthalate exposures. Studies are needed replicating our results among large multi-ethnic non-pregnant populations and assessing transgenerational effects of exposure on ovarian reserve.

Funding: This study was supported by the Erasmus Medical Center and Erasmus University Rotterdam, the Netherlands Organisation for Health Research and Development, the European Research Council, the Dutch Heart Foundation, the Dutch Diabetes Foundation, the European Union's Horizon 2020 Research and Innovation Program, the National Institutes of Health, Ansh Labs Webster, and the Royal Netherlands Academy of Arts and Sciences.

背景:女性接触干扰内分泌的化学物质可能会加速卵巢储备的耗竭,并可能与加速生殖衰老和生育能力有关。我们研究了接触双酚和邻苯二甲酸盐与抗缪勒氏管激素浓度之间的纵向联系:方法:2002 年至 2006 年间居住在鹿特丹的 18 岁或以上孕妇均有资格参与这项纵向前瞻性队列研究。我们测量了1405名孕妇在孕期三个时间点的尿液中双酚和邻苯二甲酸酯的浓度,其中1322名孕妇在产后6年和/或9年测量了血清抗苗勒氏管激素(AMH)。我们采用线性回归模型来评估尿液中双酚和邻苯二甲酸酯代谢物与 6 年和 9 年后 AMH 的关系,并采用线性混合效应模型来评估与 AMH 随时间变化的关系。模型根据社会人口学和生活方式因素进行了调整:在多变量线性回归模型中,我们观察到妊娠平均尿液中较高的邻苯二甲酸单异丁酯(mIBP)、邻苯二甲酸单(2-乙基-5-氧代己酯)(mEOHP)和邻苯二甲酸单苄酯(mBzBP)与6年和9年后较低的血清AMH有关。然而,在对多重测试进行调整后,这些关联并没有继续存在。在我们的研究样本中,双酚 A 与 AMH 没有明显的关联。在我们的线性混合效应模型中,较高的 mIBP、邻苯二甲酸单(2-乙基-5-羟基己酯)(mEHHP)、mEOHP 和 mBzBP 与较低的总体 AMH 水平相关(差异为 -0.07 (95% CI -0.13, -0.02), -0.09(-0.15,-0.02)、-0.08(95% CI -0.14,-0.02)和-0.08(-0.13,-0.03)微克/升(分别为 mIBP、mEHHP、mEOHP 和 mBzBP 每增加一倍的差异)(所有假发现率调整后的 p 值均小于 0.05):我们发现卵巢储备指数的下降与产前接触邻苯二甲酸盐有关。需要在大型多种族非妊娠人群中进行研究,复制我们的结果,并评估暴露对卵巢储备的跨代影响:本研究得到了伊拉斯谟医学中心和鹿特丹伊拉斯谟大学、荷兰卫生研究与发展组织、欧洲研究理事会、荷兰心脏基金会、荷兰糖尿病基金会、欧盟地平线 2020 研究与创新计划、美国国立卫生研究院、Ansh Labs Webster 以及荷兰皇家艺术与科学院的支持。
{"title":"Associations of bisphenol and phthalate exposure and anti-Müllerian hormone levels in women of reproductive age.","authors":"Sophia M Blaauwendraad, Ramon H M Dykgraaf, Romy Gaillard, Mengling Liu, Joop S Laven, Vincent W V Jaddoe, Leonardo Trasande","doi":"10.1016/j.eclinm.2024.102734","DOIUrl":"10.1016/j.eclinm.2024.102734","url":null,"abstract":"<p><strong>Background: </strong>In women, exposure to endocrine disrupting chemicals might accelerate the depletion of the ovarian reserve and might be associated with accelerative reproductive aging and fertility. We examined the longitudinal associations of exposure to bisphenols and phthalates with anti-Müllerian hormone concentrations.</p><p><strong>Methods: </strong>Pregnant women of 18 years or older that resided in Rotterdam between 2002 and 2006 were eligible for participation in this longitudinal prospective cohort study. We measured urinary bisphenol and phthalate concentration at three time-points in pregnancy among 1405 women, of whom 1322 women had serum Anti-Müllerian Hormone (AMH) measurements 6 and/or 9 years postpartum. We performed linear regression models to assess the association of urinary bisphenol and phthalate metabolites with AMH after 6 and 9 years, and linear mixed-effect model to assess the association with AMH over time. Models were adjusted for sociodemographic and lifestyle factors.</p><p><strong>Findings: </strong>In our multivariable linear regression models we observed associations of higher urinary pregnancy-averaged mono-isobutyl phthalate (mIBP), mono-(2-ethyl-5-oxohexyl) phthalate (mEOHP), and monobenzyl phthalate (mBzBP) with lower serum AMH after both 6 and 9 years. However, these associations did not remain after adjustment for multiple testing. No significant associations of bisphenol A with AMH were present in our study sample. In our linear mixed-effects models, higher mIBP, mono-(2-ethyl-5-hydroxyhexyl) phthalate (mEHHP), mEOHP, and mBzBP were associated with lower overall AMH levels (differences -0.07 (95% CI -0.13, -0.02), -0.09 (-0.15, -0.02), -0.08 (95% CI -0.14, -0.02), and -0.08 (-0.13, -0.03) μg/L per doubling in mIBP, mEHHP, mEOHP, and mBzBP respectively) (all False Discovery Rate adjusted p-values < 0.05).</p><p><strong>Interpretation: </strong>We identify decreases in indices of ovarian reserve in relationship to prenatal phthalate exposures. Studies are needed replicating our results among large multi-ethnic non-pregnant populations and assessing transgenerational effects of exposure on ovarian reserve.</p><p><strong>Funding: </strong>This study was supported by the Erasmus Medical Center and Erasmus University Rotterdam, the Netherlands Organisation for Health Research and Development, the European Research Council, the Dutch Heart Foundation, the Dutch Diabetes Foundation, the European Union's Horizon 2020 Research and Innovation Program, the National Institutes of Health, Ansh Labs Webster, and the Royal Netherlands Academy of Arts and Sciences.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11304696/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141901239","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
Eribulin versus S-1 as first or second-line chemotherapy to assess health-related quality of life and overall survival in HER2-negative metastatic breast cancer (RESQ study): a non-inferiority, randomised, controlled, open-label, phase 3 trial. 伊瑞布林与 S-1 作为一线或二线化疗,评估 HER2 阴性转移性乳腺癌患者的健康相关生活质量和总生存期(RESQ 研究):一项非劣效性、随机对照、开放标签的 3 期试验。
IF 9.6 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-16 eCollection Date: 2024-08-01 DOI: 10.1016/j.eclinm.2024.102715
Masato Takahashi, Yuichiro Kikawa, Kosuke Kashiwabara, Naruto Taira, Tsuguo Iwatani, Kojiro Shimozuma, Shoichiro Ohtani, Tetsuhiro Yoshinami, Junichiro Watanabe, Masahiro Kashiwaba, Ken-Ichi Watanabe, Masahiro Kitada, Koichi Sakaguchi, Yuko Tanabe, Tomohiko Aihara, Hirofumi Mukai

Background: Eribulin prolongs overall survival (OS) of patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC), particularly in later chemotherapy (ChT) treatment. However, the health-related quality of life (HRQoL) and efficacy of first or second-line therapy in eribulin-treated patients remain unknown. Using eribulin in the first- or second-line may demonstrate the non-inferiority of HRQoL compared to S-1, an oral 5-fluorouracil derivative, while maintaining OS.

Methods: This randomised, controlled, open-label, phase III trial was conducted at 50 hospitals in Japan. Patients were enrolled from June 2016 and October 2019. Patients with HER2-negative MBC once under or no previous ChT were randomly assigned (1:1) to receive eribulin or S-1. HRQoL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) every six weeks until week 24 and every nine weeks until week 42. The primary endpoint was the deterioration defined as more than 10 points worsening of the general health score of QLQ-C30 or death within one year after randomisation. The secondary endpoints included OS. (Trial ID: UMIN000021398).

Findings: Three hundred and two patients were enrolled, with 152 and 148 assigned to the eribulin and S-1 groups, respectively. The questionnaire compliance rate was 85.6%. Risk difference of global health status deterioration through one year was -0.66% (95% CI: -12.47-11.16; non-inferiority P = 0.077) for eribulin compared to S-1 groups. Median time to first deterioration for global health status score was 5.64 (95% CI: 3.51-8.00) and 5.28 months (95% CI: 3.28-7.80) in the eribulin and S-1 groups, respectively. The median OS was 34.7 and 27.8 months, (HR: 0.72, 95% CI: 0.54-0.96; P = 0.026); the median progression-free survival was 7.57 and 6.75 months in the eribulin and S-1 groups, (HR: 0.88, 95% CI: 0.67-1.16; P = 0.35), respectively. No new adverse events occurred.

Interpretation: The time of the first clinical deterioration was similar between the two groups and OS significantly increased in eribulin-treated patients.

Funding: This study was funded by CSPOR-BC and Eisai CO., Ltd.

研究背景艾瑞布林可延长人表皮生长因子受体2(HER2)阴性转移性乳腺癌(MBC)患者的总生存期(OS),尤其是在后期化疗(ChT)治疗中。然而,艾瑞布林治疗患者的健康相关生活质量(HRQoL)和一线或二线治疗的疗效仍是未知数。与口服5-氟尿嘧啶衍生物S-1相比,在一线或二线治疗中使用艾瑞布林可证明HRQoL的非劣效性,同时保持OS:这项随机对照、开放标签的 III 期试验在日本 50 家医院进行。患者入组时间为2016年6月至2019年10月。HER2阴性MBC曾接受过一次ChT治疗或未接受过ChT治疗的患者被随机分配(1:1)接受艾瑞布林或S-1治疗。HRQoL采用欧洲癌症研究和治疗组织(EORTC)生活质量问卷-核心30(QLQ-C30)进行评估,第24周之前每6周评估一次,第42周之前每9周评估一次。主要终点是随机化后一年内QLQ-C30一般健康评分恶化10分以上或死亡。次要终点包括 OS。(试验编号:UMIN000021398):共招募了 32 名患者,其中 152 名和 148 名分别被分配到艾瑞布林组和 S-1 组。问卷符合率为 85.6%。与S-1组相比,埃里布林组一年内总体健康状况恶化的风险差异为-0.66%(95% CI:-12.47-11.16;非劣效P = 0.077)。艾瑞布林组和S-1组的总体健康状况评分首次恶化的中位时间分别为5.64个月(95% CI:3.51-8.00)和5.28个月(95% CI:3.28-7.80)。中位OS分别为34.7个月和27.8个月(HR:0.72,95% CI:0.54-0.96;P = 0.026);艾瑞布林组和S-1组的中位无进展生存期分别为7.57个月和6.75个月(HR:0.88,95% CI:0.67-1.16;P = 0.35)。无新的不良事件发生:两组患者首次临床病情恶化的时间相似,埃里布林治疗组患者的OS显著增加:本研究由 CSPOR-BC 和卫材株式会社资助。
{"title":"Eribulin versus S-1 as first or second-line chemotherapy to assess health-related quality of life and overall survival in HER2-negative metastatic breast cancer (RESQ study): a non-inferiority, randomised, controlled, open-label, phase 3 trial.","authors":"Masato Takahashi, Yuichiro Kikawa, Kosuke Kashiwabara, Naruto Taira, Tsuguo Iwatani, Kojiro Shimozuma, Shoichiro Ohtani, Tetsuhiro Yoshinami, Junichiro Watanabe, Masahiro Kashiwaba, Ken-Ichi Watanabe, Masahiro Kitada, Koichi Sakaguchi, Yuko Tanabe, Tomohiko Aihara, Hirofumi Mukai","doi":"10.1016/j.eclinm.2024.102715","DOIUrl":"10.1016/j.eclinm.2024.102715","url":null,"abstract":"<p><strong>Background: </strong>Eribulin prolongs overall survival (OS) of patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC), particularly in later chemotherapy (ChT) treatment. However, the health-related quality of life (HRQoL) and efficacy of first or second-line therapy in eribulin-treated patients remain unknown. Using eribulin in the first- or second-line may demonstrate the non-inferiority of HRQoL compared to S-1, an oral 5-fluorouracil derivative, while maintaining OS.</p><p><strong>Methods: </strong>This randomised, controlled, open-label, phase III trial was conducted at 50 hospitals in Japan. Patients were enrolled from June 2016 and October 2019. Patients with HER2-negative MBC once under or no previous ChT were randomly assigned (1:1) to receive eribulin or S-1. HRQoL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) every six weeks until week 24 and every nine weeks until week 42. The primary endpoint was the deterioration defined as more than 10 points worsening of the general health score of QLQ-C30 or death within one year after randomisation. The secondary endpoints included OS. (Trial ID: UMIN000021398).</p><p><strong>Findings: </strong>Three hundred and two patients were enrolled, with 152 and 148 assigned to the eribulin and S-1 groups, respectively. The questionnaire compliance rate was 85.6%. Risk difference of global health status deterioration through one year was -0.66% (95% CI: -12.47-11.16; non-inferiority P = 0.077) for eribulin compared to S-1 groups. Median time to first deterioration for global health status score was 5.64 (95% CI: 3.51-8.00) and 5.28 months (95% CI: 3.28-7.80) in the eribulin and S-1 groups, respectively. The median OS was 34.7 and 27.8 months, (HR: 0.72, 95% CI: 0.54-0.96; P = 0.026); the median progression-free survival was 7.57 and 6.75 months in the eribulin and S-1 groups, (HR: 0.88, 95% CI: 0.67-1.16; P = 0.35), respectively. No new adverse events occurred.</p><p><strong>Interpretation: </strong>The time of the first clinical deterioration was similar between the two groups and OS significantly increased in eribulin-treated patients.</p><p><strong>Funding: </strong>This study was funded by CSPOR-BC and Eisai CO., Ltd.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11301378/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897075","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
The care cascade of chronic obstructive pulmonary disease in China: a cross-sectional study of individual-level data at enrolment into the national 'Happy Breathing' Programme. 中国慢性阻塞性肺病的护理级联:国家 "快乐呼吸 "项目入选时个人层面数据的横断面研究。
IF 9.6 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-16 eCollection Date: 2024-08-01 DOI: 10.1016/j.eclinm.2024.102597
Chen Wang, Weiran Qi, Ting Yang, Lirui Jiao, Qiushi Chen, Ke Huang, Fengyun Yu, Pascal Geldsetzer, Till Bärnighausen, Simiao Chen

Background: Understanding the chronic obstructive pulmonary disease (COPD) care cascade is crucial for identifying where and when to intervene to improve COPD outcomes. We aimed to determine the proportion of patients with COPD seeking care in China's health system who are lost at each stage of the COPD care cascade and how the patterns of loss vary across geographical regions and population groups.

Methods: From November 3, 2018, to April 22, 2021, we used individual-level patient data from the national Chinese 'Happy Breathing' Programme, which aims to identify patients with COPD and provide appropriate care. COPD was defined as a post-bronchodilator ratio of forced expiratory volume in 1 s to forced vital capacity (FEV1/FVC) <0.70. We calculated the proportions of individuals who, at enrolment into the 'Happy Breathing' Programme, (i) had ever undergone a pulmonary function test, (ii) had been diagnosed with COPD in the past, (iii) were currently on treatment for COPD, and (iv) had achieved control of their COPD. We examined the association between reaching each stage of the care cascade and individual patient characteristics as well as regional-level economic development and available resources in the health system using multilevel regression.

Findings: Among the 29,201 patients with COPD in the 'Happy Breathing' Programme, 41.0% (95% confidence interval [CI]: 40.4-41.6%) had ever been tested for COPD, 17.6% (95% CI: 17.1-18.0%) had previously been diagnosed with COPD, 8.5% (95% CI: 8.2-8.8%) were currently on treatment for COPD, 4.6% (95% CI: 4.3-4.8%) of patients had mild or no exacerbations in the prior year, and 3.9% (95% CI: 3.7-4.2%) of patients had suffered no exacerbations in the prior year. On average, patients living in the cities of Beijing, Wuhan, and Yinchuan had progressed further along the COPD care cascade than patients living in Daqing and Luoyang. Using multilevel regression, we found that young age, rural residence, and low regional per-capita GDP were significantly associated with larger losses at each stage of the COPD care cascade.

Interpretation: Substantial proportions of patients with COPD are lost at each stage of the COPD care cascade in the Chinese health system. The largest losses occur during the initial stages of the cascade, when diagnosis first occurs. New policies and interventions are required to boost COPD care, especially screening and diagnosis, in the Chinese health system to reduce this large disease burden.

Funding: This work was supported by Major Programme of National Natural Science Foundation of China (82090011), CAMS Innovation Fund for Medical Sciences (CIFMS) (2021-I2M-1-049), and Horizon Europe (HORIZON-MSCA-2021-SE-01; project number 101086139-PoPMeD-SuSDeV). TB was supported by the Alexander von Humboldt Foundation through the Alexander von Humboldt professorship award.

背景:了解慢性阻塞性肺病(COPD)的治疗过程对于确定何时何地进行干预以改善慢性阻塞性肺病的治疗效果至关重要。我们旨在确定在中国卫生系统中寻求治疗的慢性阻塞性肺疾病患者在慢性阻塞性肺疾病治疗级联的每个阶段流失的比例,以及不同地理区域和人群的流失模式有何差异:从 2018 年 11 月 3 日至 2021 年 4 月 22 日,我们使用了来自中国 "快乐呼吸 "全国项目的个人层面患者数据,该项目旨在识别慢性阻塞性肺病患者并提供适当的护理。慢性阻塞性肺病的定义是支气管扩张剂后 1 秒用力呼气容积与用力肺活量的比值(FEV1/FVC)结果:在参加 "快乐呼吸 "计划的 29 201 名慢性阻塞性肺病患者中,41.0%(95% 置信区间 [CI]:40.4-41.6%)曾接受过慢性阻塞性肺病检测,17.6%(95% 置信区间:17.1-18.0%)曾被诊断患有慢性阻塞性肺病,8.5%(95% CI:8.2%-8.8%)的患者目前正在接受慢性阻塞性肺病治疗,4.6%(95% CI:4.3%-4.8%)的患者上一年病情轻微或没有加重,3.9%(95% CI:3.7%-4.2%)的患者上一年病情没有加重。平均而言,居住在北京、武汉和银川市的患者比居住在大庆和洛阳的患者在慢性阻塞性肺疾病护理级联方面取得了更大的进展。通过多层次回归,我们发现年轻、居住在农村和地区人均 GDP 低与慢性阻塞性肺病护理级联各阶段的较大损失显著相关:在中国医疗系统中,慢性阻塞性肺疾病患者在慢性阻塞性肺疾病治疗级联的每个阶段都有相当大比例的流失。最大的损失发生在级联的初始阶段,即首次诊断时。中国卫生系统需要新的政策和干预措施来促进慢性阻塞性肺病的治疗,尤其是筛查和诊断,以减轻这一巨大的疾病负担:本研究得到了国家自然科学基金重大项目(82090011)、中国医学科学院医学科学创新基金(CIFMS)(2021-I2M-1-049)和欧洲地平线(HORIZON-MSCA-2021-SE-01;项目编号101086139-PoPMeD-SuSDeV)的资助。TB 由亚历山大-冯-洪堡基金会通过亚历山大-冯-洪堡教授奖提供支持。
{"title":"The care cascade of chronic obstructive pulmonary disease in China: a cross-sectional study of individual-level data at enrolment into the national 'Happy Breathing' Programme.","authors":"Chen Wang, Weiran Qi, Ting Yang, Lirui Jiao, Qiushi Chen, Ke Huang, Fengyun Yu, Pascal Geldsetzer, Till Bärnighausen, Simiao Chen","doi":"10.1016/j.eclinm.2024.102597","DOIUrl":"10.1016/j.eclinm.2024.102597","url":null,"abstract":"<p><strong>Background: </strong>Understanding the chronic obstructive pulmonary disease (COPD) care cascade is crucial for identifying where and when to intervene to improve COPD outcomes. We aimed to determine the proportion of patients with COPD seeking care in China's health system who are lost at each stage of the COPD care cascade and how the patterns of loss vary across geographical regions and population groups.</p><p><strong>Methods: </strong>From November 3, 2018, to April 22, 2021, we used individual-level patient data from the national Chinese 'Happy Breathing' Programme, which aims to identify patients with COPD and provide appropriate care. COPD was defined as a post-bronchodilator ratio of forced expiratory volume in 1 s to forced vital capacity (FEV1/FVC) <0.70. We calculated the proportions of individuals who, at enrolment into the 'Happy Breathing' Programme, (i) had ever undergone a pulmonary function test, (ii) had been diagnosed with COPD in the past, (iii) were currently on treatment for COPD, and (iv) had achieved control of their COPD. We examined the association between reaching each stage of the care cascade and individual patient characteristics as well as regional-level economic development and available resources in the health system using multilevel regression.</p><p><strong>Findings: </strong>Among the 29,201 patients with COPD in the 'Happy Breathing' Programme, 41.0% (95% confidence interval [CI]: 40.4-41.6%) had ever been tested for COPD, 17.6% (95% CI: 17.1-18.0%) had previously been diagnosed with COPD, 8.5% (95% CI: 8.2-8.8%) were currently on treatment for COPD, 4.6% (95% CI: 4.3-4.8%) of patients had mild or no exacerbations in the prior year, and 3.9% (95% CI: 3.7-4.2%) of patients had suffered no exacerbations in the prior year. On average, patients living in the cities of Beijing, Wuhan, and Yinchuan had progressed further along the COPD care cascade than patients living in Daqing and Luoyang. Using multilevel regression, we found that young age, rural residence, and low regional per-capita GDP were significantly associated with larger losses at each stage of the COPD care cascade.</p><p><strong>Interpretation: </strong>Substantial proportions of patients with COPD are lost at each stage of the COPD care cascade in the Chinese health system. The largest losses occur during the initial stages of the cascade, when diagnosis first occurs. New policies and interventions are required to boost COPD care, especially screening and diagnosis, in the Chinese health system to reduce this large disease burden.</p><p><strong>Funding: </strong>This work was supported by Major Programme of National Natural Science Foundation of China (82090011), CAMS Innovation Fund for Medical Sciences (CIFMS) (2021-I2M-1-049), and Horizon Europe (HORIZON-MSCA-2021-SE-01; project number 101086139-PoPMeD-SuSDeV). TB was supported by the Alexander von Humboldt Foundation through the Alexander von Humboldt professorship award.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11305216/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141901311","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
ESMO gynaecological cancers congress 2024. 2024 年 ESMO 妇科癌症大会。
IF 9.6 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-13 eCollection Date: 2024-08-01 DOI: 10.1016/j.eclinm.2024.102738
Elena Bellafante
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引用次数: 0
In need of robust evidence of non-association of pregestational and early pregnancy SARS-CoV-2 infections with congenital anomalies. 需要强有力的证据证明孕前和孕早期感染 SARS-CoV-2 与先天性畸形无关。
IF 9.6 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-13 eCollection Date: 2024-08-01 DOI: 10.1016/j.eclinm.2024.102729
Athina Samara, Vivienne Souter, Conrado Milani Coutinho, Asma Khalil

SARS-CoV-2 infection during pregestational and early pregnancy periods has an unclear impact on fetal development. Although vertical transmission is rare, potential effects on the developing fetal brain are plausible. However, robust evidence linking maternal SARS-CoV-2 infection to congenital anomalies is limited due to inadequate tracking of infection history and methodological flaws in published studies. This is further complicated by limitations, such as restricted testing access and undiagnosed infections, particularly in low- and middle-income countries. Most data focus on hospitalized women near term, lacking information on first- and second-trimester infections. Thus, an accurate assessment of the impact of COVID-19 on congenital anomalies is essential. It should however be emphasised that we have robust evidence that vaccination against COVID-19 before or during early pregnancy is not associated with malformations, ruling out any role of COVID-19 vaccines in these increased rates of congenital abnormalities. This viewpoint discusses findings from surveillance registries, highlights study limitations, and offers research recommendations to inform clinical guidelines and public health strategies, aiming to mitigate the effects of viral infections on early neurodevelopment.

孕前和孕早期感染 SARS-CoV-2 对胎儿发育的影响尚不明确。虽然垂直传播很少见,但对胎儿大脑发育的潜在影响是可信的。然而,由于对感染史的追踪不足以及已发表研究在方法上的缺陷,将母体感染 SARS-CoV-2 与先天性畸形联系起来的有力证据十分有限。尤其是在低收入和中等收入国家,检测途径受限和未确诊感染等限制因素使情况更加复杂。大多数数据集中于临近分娩的住院妇女,缺乏第一和第二孕期感染的信息。因此,准确评估 COVID-19 对先天性畸形的影响至关重要。但需要强调的是,我们有确凿的证据表明,在孕前或孕早期接种 COVID-19 疫苗与畸形无关,这就排除了 COVID-19 疫苗在先天性畸形率上升中的作用。本观点讨论了监测登记的结果,强调了研究的局限性,并提出了研究建议,为临床指南和公共卫生策略提供参考,旨在减轻病毒感染对早期神经发育的影响。
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引用次数: 0
Global epidemiology, natural history, maternal-to-child transmission, and treatment with DAA of pregnant women with HCV: a systematic review and meta-analysis. 感染 HCV 孕妇的全球流行病学、自然史、母婴传播和 DAA 治疗:系统回顾和荟萃分析。
IF 9.6 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-13 eCollection Date: 2024-08-01 DOI: 10.1016/j.eclinm.2024.102727
Joo Wei Ethan Quek, Jing Hong Loo, En Qi Lim, Ambrose Hon-Lam Chung, Abu Bakar Bin Othman, Jarell Jie-Rae Tan, Scott Barnett, Mindie H Nguyen, Yu Jun Wong

Background: Pregnant women with hepatitis C virus (HCV) infection represent a special population in which treatment access remains limited despite its increasing prevalence. A reliable estimate of the burden and clinical outcomes of pregnant women with HCV infection is crucial for HCV elimination. We aimed to determine the prevalence, maternal-to-child transmission (MTCT), maternal and fetal complication rates, and direct acting antivirals (DAA) treatment outcomes of chronic HCV infection in pregnant women.

Methods: We searched PubMed, EMBASE, Scopus, Web of Science from inception until March 1, 2024, for studies reporting on the prevalence, MTCT, complications of HCV infection, and treatment outcomes of DAA in pregnant women. Study quality was assessed using the Newcastle-Ottawa Scale. We performed subgroup analysis based on 9 variables to explore the source of heterogeneity in HCV prevalence. The PROSPERO registration number is CRD42024500023.

Findings: From a total of 311,905,738 pregnant women from 333 studies, the pooled global seroprevalence of HCV in pregnant women was 2.6% (95% CI: 2.0-3.2, I 2 = 100%) which increased in patients with intravenous drug use and HIV. Majority of the HCV cases in pregnant women (75%) are diagnosed through universal screening. The pooled MTCT rate was 9.0% (95% CI: 6.6-11.7, I 2 = 79%), which was higher with HIV co-infection (OR: 3.1, 95% CI: 2.1-4.6, I 2 = 10%), but was not influenced by the mode of delivery or breastfeeding. Pregnant women with HCV infection had more maternal complications, including intrahepatic cholestasis, preterm delivery, and antepartum hemorrhage. Neonates of mothers with HCV had higher odds of being small for gestational age. The pooled rate of sustained virologic response (SVR12) among the 74 women treated with DAA during pregnancy was 98.4%, with no serious adverse events reported.

Interpretation: HCV prevalence in pregnant women varies by geographic region and patient population, while MTCT occurs in almost one in ten viremic mothers. The incidence of both maternal and neonatal complications is significantly higher in patients with HCV infection. Limited data suggest that DAA are safe in pregnant women with HCV infection.

Funding: None.

背景:感染丙型肝炎病毒(HCV)的孕妇是一个特殊群体,尽管丙型肝炎病毒(HCV)感染率不断上升,但其治疗机会仍然有限。对感染丙型肝炎病毒(HCV)的孕妇的负担和临床结果进行可靠的估计,对于消除丙型肝炎病毒(HCV)至关重要。我们旨在确定孕妇慢性 HCV 感染的患病率、母婴传播(MTCT)、母体和胎儿并发症发生率以及直接作用抗病毒药物(DAA)的治疗效果:我们检索了 PubMed、EMBASE、Scopus 和 Web of Science 中从开始到 2024 年 3 月 1 日有关孕妇感染率、母婴传播、HCV 感染并发症和 DAA 治疗效果的研究报告。研究质量采用纽卡斯尔-渥太华量表进行评估。我们根据 9 个变量进行了亚组分析,以探讨 HCV 感染率的异质性来源。PROSPERO注册号为CRD42024500023:来自 333 项研究的 311,905,738 名孕妇中,汇总的全球孕妇 HCV 血清流行率为 2.6%(95% CI:2.0-3.2,I 2 = 100%),在静脉注射毒品和感染 HIV 的患者中流行率有所上升。大多数孕妇的 HCV 病例(75%)是通过普遍筛查确诊的。汇总的母婴传播率为 9.0%(95% CI:6.6-11.7,I 2 = 79%),合并感染艾滋病毒的孕妇感染率更高(OR:3.1,95% CI:2.1-4.6,I 2 = 10%),但不受分娩方式或母乳喂养的影响。感染 HCV 的孕妇有更多的产妇并发症,包括肝内胆汁淤积症、早产和产前出血。感染 HCV 的母亲所生的新生儿胎龄小的几率更高。在妊娠期接受DAA治疗的74名妇女中,持续病毒学应答(SVR12)的汇总率为98.4%,无严重不良事件报告:解读:孕妇中的 HCV 感染率因地理区域和患者人群而异,而每十个感染病毒的母亲中就有一个会发生母婴传播。在感染 HCV 的患者中,孕产妇和新生儿并发症的发生率明显较高。有限的数据表明,DAA 对感染 HCV 的孕妇是安全的:无。
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引用次数: 0
Integrating gender analysis into research: reflections from the Gender-Net Plus workshop. 将性别分析纳入研究:Gender-Net Plus 研讨会的反思。
IF 9.6 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-13 eCollection Date: 2024-08-01 DOI: 10.1016/j.eclinm.2024.102728
Christopher R Cederroth, Brian D Earp, Hernando C Gómez Prada, Carlotta M Jarach, Shlomit A Lir, Colleen M Norris, Louise Pilote, Valeria Raparelli, Paula Rochon, Nina Sahraoui, Cassandra Simmon, Bilkis Vissandjee, Chloé Mour, Mathieu Arbogast, José María Armengol, Robin Mason

Gender equality has been a crosscutting issue in Horizon 2020 with three objectives: gender balance in decision-making, gender balance and equal opportunities in project teams at all levels, and inclusion of the gender dimension in research and innovation content. Between 2017 and 2022, the EU funded, in collaboration with national agencies, 13 transnational projects under "GENDER-NET Plus" that explored how to best integrate both sex and gender into studies ranging from social sciences, humanities, and health research. As the projects neared completion, forty researchers from these interdisciplinary teams met in November 2022 to share experiences, discuss challenges, and consider the best ways forward to incorporate sex and gender in research. Here, we summarize the reflections from this workshop and provide some recommendations for i) how to plan the studies (e.g., how to define sex and/or gender and their dimensions, rationale for the hypotheses, identification of data that can best answer the research question), ii) how to conduct them (e.g., adjust definitions and dimensions, perform pilot studies to ensure proper use of terminology and revise until consensus is achieved), and iii) how to analyze and report the findings being mindful of any real-world impact.

性别平等一直是 "地平线 2020 "的一个跨领域问题,有三个目标:决策中的性别平衡、各级项目团队中的性别平衡和机会平等,以及在研究和创新内容中纳入性别维度。2017 年至 2022 年期间,欧盟与国家机构合作,资助了 "GENDER-NET Plus "下的 13 个跨国项目,探讨如何将性与性别最好地融入社会科学、人文科学和健康研究等各种研究中。随着这些项目接近尾声,来自这些跨学科团队的 40 名研究人员于 2022 年 11 月聚首一堂,分享经验、讨论挑战,并思考将性与性别问题纳入研究的最佳途径。在此,我们总结了此次研讨会的反思,并就以下方面提出了一些建议:i) 如何规划研究(例如,如何定义性和/或性别及其维度、假设的基本原理、确定能够最好地回答研究问题的数据);ii) 如何开展研究(例如,调整定义和维度、开展试点研究以确保术语的正确使用,并在达成共识之前进行修订);iii) 如何分析和报告研究结果,并注意对现实世界的影响。
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引用次数: 0
Improving COVID-19 contact tracing and testing of exposed individuals in Cameroon using digital health technology: a cluster randomised trial. 利用数字医疗技术改进喀麦隆 COVID-19 接触者追踪和检测:群组随机试验。
IF 9.6 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-13 eCollection Date: 2024-08-01 DOI: 10.1016/j.eclinm.2024.102730
Boris Tchakounte Youngui, Albert Mambo, Rhoderick Machekano, Rogacien Kana, Emilienne Epée, Sylvain Zemsi Tenkeu, Philippe Narcisse Tsigaing, Marie Louise Aimée Ndongo, Christelle Mayap Njoukam, Lawane Bichara, Tatiana Djikeussi Katcho, Muhamed Awolu Mbunka, Terence Acheliu Longla, Leonie Simo, Adrienne Vanessa Kouatchouang, Patrice Tchendjou, Appolinaire Tiam, Laura Guay, Khairunisa Suleiman, Olukunle Akinwusi, Rigveda Kadam, Paula Akugizibwe, Mario Songane, Godfrey Woelk, Boris Kevin Tchounga

Background: Contact tracing was described as a key strategy to contribute to controlling the spread of severe acute respiratory syndrome of Coronavirus 2 (SARS-CoV-2) but implementing it can be a challenge. Digitalisation of contact tracing is among the proposed solutions being explored in sub-Saharan African settings. We assessed the effectiveness of a digital tool to expand SARS-CoV-2 testing in exposed individuals in Cameroon.

Methods: We conducted a cluster-randomised (1:1) trial in eight health districts, including 22 facilities and SARS-CoV-2 testing units, randomly assigned to a digital (intervention) or standard (control) contact tracing approach. The intervention consisted of a contact tracing module added to the digital platform "Mamal PRO" used for monitoring and coordination of Coronavirus Disease 2019 pandemic response in Cameroon. The primary outcome was the proportion of contacts declared by SAR-CoV-2 index patients who were successfully traced and tested for SARS-CoV-2 evaluated with a Poisson regression model with cluster adjustment. This study is registered with ClinicalTrials.gov (NCT05684887).

Findings: Between October 18, 2022, and March 31, 2023, we enrolled 164 index patients in the intervention arm and 149 in the control arm, who identified 854 and 849 contacts, respectively. In the intervention arm, 93.8% (801/854) of identified contacts were successfully reached by the tracing unit versus 54.5% (463/849) in the control arm. The intervention significantly increased the likelihood of successfully tracing contacts (adjusted relative risks (RR) 1.72 [95% CI: 1.00-2.95], p = 0.049). The median (interquartile range, IQR) time to successfully tracing contacts was 0 days [IQR: 0, 1] in the intervention and 1 day [IQR: 0, 2] in the control arm. In the intervention arm, 21.3% (182/854) of identified contacts received SARS-CoV-2 testing compared to 14.5% (123/849) in the control arm (adjusted RR 1.47 [95% CI: 0.44-4.90], p = 0.530).

Interpretation: Digitalising the contact tracing process improved exposure notification and facilitated the tracing of a greater number of contacts of individuals infected with SARS-CoV-2 in resource-limited settings.

Funding: The study was funded by FIND, United Kingdom (FCDO 40105983), Switzerland (81066910), Netherlands (SDD 4000004160), Canada (DFATD 7429348), The Kingdom of Saudi Arabia (FIND-ACT-A DX PARTNERSHIP 20.08.2020), The Rockefeller Foundation (2020 HTH 059), Germany (BMZ Covid-19 Diagnostic and Surveillance Response 27.07.2021), Australia (DFAT 76442), Kuwait (M239/2020), The Government of Portugal and Partners (ANF, BCP, CGF, APIFARMA) and The BlackRock Foundation (Grant Agreement as of April 20, 2022).

背景:接触者追踪被认为是有助于控制严重急性呼吸系统综合症冠状病毒 2(SARS-CoV-2)传播的关键策略,但实施起来却很困难。接触者追踪数字化是撒哈拉以南非洲地区正在探索的解决方案之一。我们评估了数字化工具在喀麦隆扩大接触者 SARS-CoV-2 检测范围的有效性:我们在八个卫生区进行了分组随机(1:1)试验,包括 22 个设施和 SARS-CoV-2 检测单位,随机分配到数字(干预)或标准(对照)接触者追踪方法。干预措施包括在数字平台 "Mamal PRO "中添加接触者追踪模块,该平台用于监测和协调喀麦隆 2019 年冠状病毒疾病大流行应对工作。主要结果是,SARS-CoV-2指数患者申报的接触者中,成功追踪到并接受SARS-CoV-2检测的接触者所占比例。本研究已在 ClinicalTrials.gov (NCT05684887) 注册:2022年10月18日至2023年3月31日期间,我们在干预组和对照组分别招募了164名和149名指数患者,他们分别确定了854名和849名接触者。在干预组中,93.8%(801/854)的已确认联系人成功联系到追踪单位,而在对照组中,这一比例为 54.5%(463/849)。干预措施极大地提高了成功追踪接触者的可能性(调整后相对风险 (RR) 1.72 [95% CI: 1.00-2.95],p = 0.049)。成功追踪接触者的中位时间(四分位数间距,IQR)在干预组为 0 天 [IQR: 0, 1],在对照组为 1 天 [IQR: 0, 2]。在干预组中,21.3%(182/854)被确认的接触者接受了 SARS-CoV-2 检测,而在对照组中,这一比例为 14.5%(123/849)(调整后 RR 为 1.47 [95% CI:0.44-4.90],p = 0.530):解释:接触者追踪过程的数字化改进了暴露通知,有助于在资源有限的环境中追踪更多感染 SARS-CoV-2 的接触者:本研究由 FIND、英国(FCDO 40105983)、瑞士(81066910)、荷兰(SDD 4000004160)、加拿大(DFATD 7429348)、沙特阿拉伯王国(FIND-ACT-A DX PARTNERSHIP 20.08.2020), The Rockefeller Foundation (2020 HTH 059), Germany (BMZ Covid-19 Diagnostic and Surveillance Response 27.07.2021), Australia (DFAT 76442), Kuwait (M239/2020), The Government of Portugal and Partners (ANF, BCP, CGF, APIFARMA) and The BlackRock Foundation (Grant Agreement as of April 20, 2022).
{"title":"Improving COVID-19 contact tracing and testing of exposed individuals in Cameroon using digital health technology: a cluster randomised trial.","authors":"Boris Tchakounte Youngui, Albert Mambo, Rhoderick Machekano, Rogacien Kana, Emilienne Epée, Sylvain Zemsi Tenkeu, Philippe Narcisse Tsigaing, Marie Louise Aimée Ndongo, Christelle Mayap Njoukam, Lawane Bichara, Tatiana Djikeussi Katcho, Muhamed Awolu Mbunka, Terence Acheliu Longla, Leonie Simo, Adrienne Vanessa Kouatchouang, Patrice Tchendjou, Appolinaire Tiam, Laura Guay, Khairunisa Suleiman, Olukunle Akinwusi, Rigveda Kadam, Paula Akugizibwe, Mario Songane, Godfrey Woelk, Boris Kevin Tchounga","doi":"10.1016/j.eclinm.2024.102730","DOIUrl":"10.1016/j.eclinm.2024.102730","url":null,"abstract":"<p><strong>Background: </strong>Contact tracing was described as a key strategy to contribute to controlling the spread of severe acute respiratory syndrome of Coronavirus 2 (SARS-CoV-2) but implementing it can be a challenge. Digitalisation of contact tracing is among the proposed solutions being explored in sub-Saharan African settings. We assessed the effectiveness of a digital tool to expand SARS-CoV-2 testing in exposed individuals in Cameroon.</p><p><strong>Methods: </strong>We conducted a cluster-randomised (1:1) trial in eight health districts, including 22 facilities and SARS-CoV-2 testing units, randomly assigned to a digital (intervention) or standard (control) contact tracing approach. The intervention consisted of a contact tracing module added to the digital platform \"Mamal PRO\" used for monitoring and coordination of Coronavirus Disease 2019 pandemic response in Cameroon. The primary outcome was the proportion of contacts declared by SAR-CoV-2 index patients who were successfully traced and tested for SARS-CoV-2 evaluated with a Poisson regression model with cluster adjustment. This study is registered with ClinicalTrials.gov (NCT05684887).</p><p><strong>Findings: </strong>Between October 18, 2022, and March 31, 2023, we enrolled 164 index patients in the intervention arm and 149 in the control arm, who identified 854 and 849 contacts, respectively. In the intervention arm, 93.8% (801/854) of identified contacts were successfully reached by the tracing unit versus 54.5% (463/849) in the control arm. The intervention significantly increased the likelihood of successfully tracing contacts (adjusted relative risks (RR) 1.72 [95% CI: 1.00-2.95], p = 0.049). The median (interquartile range, IQR) time to successfully tracing contacts was 0 days [IQR: 0, 1] in the intervention and 1 day [IQR: 0, 2] in the control arm. In the intervention arm, 21.3% (182/854) of identified contacts received SARS-CoV-2 testing compared to 14.5% (123/849) in the control arm (adjusted RR 1.47 [95% CI: 0.44-4.90], p = 0.530).</p><p><strong>Interpretation: </strong>Digitalising the contact tracing process improved exposure notification and facilitated the tracing of a greater number of contacts of individuals infected with SARS-CoV-2 in resource-limited settings.</p><p><strong>Funding: </strong>The study was funded by FIND, United Kingdom (FCDO 40105983), Switzerland (81066910), Netherlands (SDD 4000004160), Canada (DFATD 7429348), The Kingdom of Saudi Arabia (FIND-ACT-A DX PARTNERSHIP 20.08.2020), The Rockefeller Foundation (2020 HTH 059), Germany (BMZ Covid-19 Diagnostic and Surveillance Response 27.07.2021), Australia (DFAT 76442), Kuwait (M239/2020), The Government of Portugal and Partners (ANF, BCP, CGF, APIFARMA) and The BlackRock Foundation (Grant Agreement as of April 20, 2022).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11300906/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897103","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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