减少中国农村地区抗生素处方的复杂干预:分组随机对照试验

IF 7.6 1区 医学 Q1 HEALTH CARE SCIENCES & SERVICES The Lancet Regional Health: Western Pacific Pub Date : 2024-11-06 DOI:10.1016/j.lanwpc.2024.101236
Xingrong Shen , Beth Stuart , Enci Cui , Rong Liu , Tingting Zhang , Jing Chai , Wenjuan Cong , Xiaowen Hu , Isabel Oliver , Guiqing Yao , Paul Little , Helen Lambert , Lucy Yardley , Christie Cabral , Debin Wang
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引用次数: 0

摘要

背景过度使用抗生素是一个普遍存在的问题。方法 在这项双臂分组随机对照试验中,我们从中国安徽省 10 个县的 40 个乡镇卫生院(THC)中招募了 18 岁以上有症状的 RTI 患者。乡镇卫生院通过在线工具("密封信封")随机分配干预或常规护理(1:1 比例),按抗生素处方基线进行分层,并随机分配区块大小(4 或 6)。干预措施包括五个部分:为期半天的临床医生培训、基于微信的同伴支持小组、决策辅助工具、海报承诺函和患者宣传单。主要结果是在就诊时是否开具抗生素处方。次要指标包括定义的每日剂量(DDD)、疾病痊愈率、再次就诊于其他护理人员或零售药店的次数以及增量成本效益比(ICER)。采用广义线性混合模型对这些指标进行了分析,并对聚类进行了控制。研究结果在2021年12月至2022年9月期间,采用连续抽样的方法招募了1053名患者(干预组,21个THC,n = 552;对照组,19个THC,n = 501)。干预组和对照组的抗生素处方率分别为 55.25% 和 66.67%(比值比 0.52,95% 置信区间 [CI]:0.27,0.98;P = 0.044)。干预组在其他抗生素使用指标上的差异也较小,有显著性或无显著性差异:DDD(1.57 vs 2.75);两种或两种以上抗生素处方(9.78% vs 11.58%);从零售药店(3.68% vs 5.78)或其他诊所(2.70% vs 4.05%)获得抗生素。干预后,每次就诊的成本降低了 9.265 元人民币(1.471 美元),ICER 为-7769.98 元人民币或-1233.33 美元/QALYs。该干预方案对减少抗生素处方有效且具有成本效益,无不良反应。
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A complex intervention to reduce antibiotic prescribing in rural China: a cluster randomised controlled trial

Background

Excessive use of antibiotics is a widespread problem. We aim to evaluate the efficacy of a multifaceted intervention for reducing antibiotic use in patients with respiratory tract infections (RTIs).

Methods

In this two-arm cluster randomized controlled trial, we enrolled patients aged 18+ with symptomatic RTIs at 40 township health centers (THCs) selected from 10 counties in Anhui, China. The THCs were randomized using an online tool (‘Sealed Envelope’) to intervention or usual care (1:1 ratio), stratified by baseline antibiotic prescribing and with random block sizes (4 or 6). The intervention had five components: a half-day clinician training, a WeChat-based peer support group, a decision aid, a poster commitment letter and a patient leaflet. The primary outcome was whether antibiotics were prescribed at the index consultation. Secondary measures included defined daily dose (DDD), illness recovery rate, re-visits to other care-givers or retail pharmacies and incremental cost-effectiveness ratio (ICER). These measures were analyzed using generalized linear mixed modeling controlling for clustering. The study was registered as ISRCTN30652037.

Findings

Between December 2021 and September 2022, 1053 patients were recruited (intervention, 21 THCs, n = 552; control, 19 THCs, n = 501), using consecutive sampling. Antibiotic prescribing rate was 55.25% and 66.67% in the intervention and control arms (Odds ratio 0.52, 95% confidence interval [CI]: 0.27, 0.98; p = 0.044). The intervention group also had lower, significant or non-significant, differences for other markers of antibiotic use: DDD (1.57 vs 2.75); prescriptions of two or more types of antibiotics (9.78% vs 11.58%); obtaining antibiotics from retail pharmacies (3.68% vs 5.78) or from other clinics (2.70% vs 4.05%). The intervention resulted in a cost reduction of 9.265 RMB (1.471 USD) per consultation episode and an ICER of −7769.98 RMB or −1233.33 USD/QALYs. The intervention did not encounter any major adverse event.

Interpretation

The intervention package was effective and cost-effective in reducing antibiotics prescribing without adverse effects.

Funding

The trial was supported by National Natural Science Foundation of China (No. 81861138049) and United Kingdom Research Innovation (No. MR/S013717/1).
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来源期刊
The Lancet Regional Health: Western Pacific
The Lancet Regional Health: Western Pacific Medicine-Pediatrics, Perinatology and Child Health
CiteScore
8.80
自引率
2.80%
发文量
305
审稿时长
11 weeks
期刊介绍: The Lancet Regional Health – Western Pacific, a gold open access journal, is an integral part of The Lancet's global initiative advocating for healthcare quality and access worldwide. It aims to advance clinical practice and health policy in the Western Pacific region, contributing to enhanced health outcomes. The journal publishes high-quality original research shedding light on clinical practice and health policy in the region. It also includes reviews, commentaries, and opinion pieces covering diverse regional health topics, such as infectious diseases, non-communicable diseases, child and adolescent health, maternal and reproductive health, aging health, mental health, the health workforce and systems, and health policy.
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