在乌干达农村地区,由社区卫生工作者进行床旁 C 反应蛋白测量可安全减少呼吸道疾病患儿的抗菌药物使用量:阶梯式楔形分组随机试验。

IF 15.8 1区 医学 Q1 Medicine PLoS Medicine Pub Date : 2024-08-19 eCollection Date: 2024-08-01 DOI:10.1371/journal.pmed.1004416
Emily J Ciccone, Di Hu, John S Preisser, Caitlin A Cassidy, Lydiah Kabugho, Baguma Emmanuel, Georget Kibaba, Fred Mwebembezi, Jonathan J Juliano, Edgar M Mulogo, Ross M Boyce
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This study's objective was to determine the impact of CRP measurement on antibiotic use among children presenting with febrile ARI to CHW in Uganda.</p><p><strong>Methods and findings: </strong>We conducted a cross-sectional, stepped wedge cluster randomized trial in 15 villages in Bugoye subcounty comparing a clinical algorithm that included CRP measurement by CHW to guide antibiotic treatment (STAR Sick Child Job Aid [SCJA]; intervention condition) with the Integrated Community Care Management (iCCM) SCJA currently in use by CHW in the region (control condition). Villages were stratified into 3 strata by altitude, distance to the clinic, and size; in each stratum, the 5 villages were randomly assigned to one of 5 treatment sequences. Children aged 2 months to 5 years presenting to CHW with fever and cough were eligible. CHW conducted follow-up assessments 7 days after the initial visit. 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引用次数: 0

摘要

背景:急性呼吸道疾病(ARI)是儿童接受抗生素治疗的最常见原因之一。在各种临床环境中,C反应蛋白(CRP)的测量已被证明可减少急性呼吸道感染患儿不必要的抗生素使用。在许多资源有限的情况下,患者通常会在正规医疗机构之外寻求非专业社区保健员(CHWs)的治疗。本研究的目的是确定 CRP 测量对乌干达向社区保健员就诊的发热急性呼吸道感染患儿使用抗生素的影响:我们在布戈耶次县的 15 个村庄开展了一项横断面、阶梯式楔形群组随机试验,将包括由儿童保健医生测量 CRP 以指导抗生素治疗的临床算法(STAR 病童工作助手 [SCJA];干预条件)与该地区儿童保健医生目前使用的综合社区护理管理 (iCCM) SCJA(对照条件)进行比较。根据海拔高度、距离诊所的远近和村庄大小将村庄分为 3 个分层;在每个分层中,5 个村庄被随机分配到 5 个治疗序列中的一个。2 个月至 5 岁的儿童因发烧和咳嗽而向儿童保健工作者求助时,均符合条件。儿童保健工作者在首次就诊 7 天后进行随访评估。我们的主要结果是初次就诊时获得或开具抗生素处方的儿童比例。我们的次要结果是:(1)第 7 天持续发烧;(2)出现预先指定的危险征兆;(3)儿童保健工作者意外到访;(4)住院;(5)死亡;(6)第 7 天儿童的看护人认为病情未见好转;以及(7)临床失败,即第 7 天持续发烧、出现危险征兆、住院或死亡的综合结果。65 名参与的儿童保健工作者共招募了 1,280 名儿童,其中 1,220 人(95.3%)有足够的数据。在对照期(iCCM SCJA)和干预期(STAR SCJA),分别有约 48% (587/1,220)和 52% (633/1,220)的儿童接受了治疗。在首次就诊时被给予或开具抗生素处方的儿童比例,对照组为 91.8%(539/587),而干预组为 70.8%(448/633)(调整流行率差异为 -24.6%,95% CI:-36.1%,-13.1%)。与对照组相比,干预期间由社区保健员开具抗生素处方的几率降低了 80% 以上(OR 0.18,95% CI:0.06 至 0.49)。临床失败(iCCM SCJA 3.9% (23/585) v. STAR SCJA 1.8% (11/630);OR 0.41,95% CI:0.09, 1.83)和护理人员认为病情没有改善(iCCM SCJA 2.1% (12/584) v. STAR SCJA 3.5% (22/627);OR 1.49,95% CI:0.37, 6.52)的频率相似。两组患者在随访期间均无意外就诊或死亡:结论:在乌干达农村地区,将 CRP 测量纳入 iCCM 算法,由保健社工对发热 ARI 儿童进行评估,减少了抗生素的使用。有证据表明,尽管不良事件的数量较少,但抗生素使用量的减少与临床结果的恶化并无关联。这些研究结果支持在资源有限的农村地区扩大使用简单的护理点诊断方法,以改善抗生素管理,因为在这些地区,受过有限医学培训的个人提供的医疗服务占了很大比例:试验注册:ClinicalTrials.gov NCT05294510。该研究已通过北卡罗来纳大学机构审查委员会(#18-2803)、姆巴拉拉科技大学研究伦理委员会(14/03-19)和乌干达国家科技委员会(HS 2631)的审查和批准。
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Point-of-care C-reactive protein measurement by community health workers safely reduces antimicrobial use among children with respiratory illness in rural Uganda: A stepped wedge cluster randomized trial.

Background: Acute respiratory illness (ARI) is one of the most common reasons children receive antibiotic treatment. Measurement of C-reaction protein (CRP) has been shown to reduce unnecessary antibiotic use among children with ARI in a range of clinical settings. In many resource-constrained contexts, patients seek care outside the formal health sector, often from lay community health workers (CHW). This study's objective was to determine the impact of CRP measurement on antibiotic use among children presenting with febrile ARI to CHW in Uganda.

Methods and findings: We conducted a cross-sectional, stepped wedge cluster randomized trial in 15 villages in Bugoye subcounty comparing a clinical algorithm that included CRP measurement by CHW to guide antibiotic treatment (STAR Sick Child Job Aid [SCJA]; intervention condition) with the Integrated Community Care Management (iCCM) SCJA currently in use by CHW in the region (control condition). Villages were stratified into 3 strata by altitude, distance to the clinic, and size; in each stratum, the 5 villages were randomly assigned to one of 5 treatment sequences. Children aged 2 months to 5 years presenting to CHW with fever and cough were eligible. CHW conducted follow-up assessments 7 days after the initial visit. Our primary outcome was the proportion of children who were given or prescribed an antibiotic at the initial visit. Our secondary outcomes were (1) persistent fever on day 7; (2) development of prespecified danger signs; (3) unexpected visits to the CHW; (4) hospitalizations; (5) deaths; (6) lack of perceived improvement per the child's caregiver on day 7; and (7) clinical failure, a composite outcome of persistence of fever on day 7, development of danger signs, hospitalization, or death. The 65 participating CHW enrolled 1,280 children, 1,220 (95.3%) of whom had sufficient data. Approximately 48% (587/1,220) and 52% (633/1,220) were enrolled during control (iCCM SCJA) and intervention periods (STAR SCJA), respectively. The observed percentage of children who were given or prescribed antibiotics at the initial visit was 91.8% (539/587) in the control periods as compared to 70.8% (448/633) during the intervention periods (adjusted prevalence difference -24.6%, 95% CI: -36.1%, -13.1%). The odds of antibiotic prescription by the CHW were over 80% lower in the intervention as compared to the control periods (OR 0.18, 95% CI: 0.06, 0.49). The frequency of clinical failure (iCCM SCJA 3.9% (23/585) v. STAR SCJA 1.8% (11/630); OR 0.41, 95% CI: 0.09, 1.83) and lack of perceived improvement by the caregiver (iCCM SCJA 2.1% (12/584) v. STAR SCJA 3.5% (22/627); OR 1.49, 95% CI: 0.37, 6.52) was similar. There were no unexpected visits or deaths in either group within the follow-up period.

Conclusions: Incorporating CRP measurement into iCCM algorithms for evaluation of children with febrile ARI by CHW in rural Uganda decreased antibiotic use. There is evidence that this decrease was not associated with worse clinical outcomes, although the number of adverse events was low. These findings support expanded access to simple, point-of-care diagnostics to improve antibiotic stewardship in rural, resource-constrained settings where individuals with limited medical training provide a substantial proportion of care.

Trial registration: ClinicalTrials.gov NCT05294510. The study was reviewed and approved by the University of North Carolina Institutional Review Board (#18-2803), Mbarara University of Science and Technology Research Ethics Committee (14/03-19), and Uganda National Council on Science and Technology (HS 2631).

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PLoS Medicine
PLoS Medicine MEDICINE, GENERAL & INTERNAL-
CiteScore
17.60
自引率
0.60%
发文量
227
审稿时长
4-8 weeks
期刊介绍: PLOS Medicine is a prominent platform for discussing and researching global health challenges. The journal covers a wide range of topics, including biomedical, environmental, social, and political factors affecting health. It prioritizes articles that contribute to clinical practice, health policy, or a better understanding of pathophysiology, ultimately aiming to improve health outcomes across different settings. The journal is unwavering in its commitment to uphold the highest ethical standards in medical publishing. This includes actively managing and disclosing any conflicts of interest related to reporting, reviewing, and publishing. PLOS Medicine promotes transparency in the entire review and publication process. The journal also encourages data sharing and encourages the reuse of published work. Additionally, authors retain copyright for their work, and the publication is made accessible through Open Access with no restrictions on availability and dissemination. PLOS Medicine takes measures to avoid conflicts of interest associated with advertising drugs and medical devices or engaging in the exclusive sale of reprints.
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