| 引用本文:龙政莉1，孙铭璘2，邓辉1，孙睿婕1，赵宁侠3，刘佳1，2.基于儿童孤独症的针灸真实世界研究方法探索[J].世界中医药,2024,(07):. |
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| 基于儿童孤独症的针灸真实世界研究方法探索 |
| Exploration of Real-world Research Methods for Acupuncture and Moxibustion Based on Childhood Autism |
| 投稿时间：2023-11-28 |
| DOI：10.3969/j.issn.1673-7202.2024.07.003 |
| 中文关键词: 针灸 真实世界研究 儿童孤独症 研究方法 成果转化 疗效评价 效应优势 综述 |
| English Keywords:Acupuncture and moxibustion Real-world study Childhood autism Research methods Achievement transformation Efficacy evaluation Effect advantage Review |
| 基金项目:国家重点研发计划项目（2019YFC1712200）;国际针灸临床研究服务标准研制课题（2019YFC1712205）；中国中医科学院创新工程课题（CI2021A00702-02）——基于疾病研究的真实世界临床评价及数据治理分析关键技术研究；中国中医科学院结余经费再立项课题（2023014-212090）——儿童孤独症谱系障碍结局管理及干预新技术研发 |
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| 中文摘要: |
| 真实世界研究（RWS）是一种基于对真实临床医疗数据进行收集、处理、分析并从多角度解读的研究，因其研究结果具有内在有效性和外部可推性的特点，越来越受到针灸学界的重视。通过分析RWS与儿童孤独症谱系障碍（ASD）针灸临床研究的相适性，认为RWS在儿童ASD研究中价值医疗显著，提出了儿童ASD针灸真实世界研究可能存在的问题：1）缺乏高质量针灸临床研究证据；2）没有形成临床评价体系；3）临床研究成果转化脱节。针对存在的问题，探讨了儿童ASD针灸RWS方法相应的解决办法：1）实施场景、研究时间、样本量应根据真实数据来确定；2）因纳入排除标准较为宽泛，受试者具有广泛代表性，无需对其依从性进行密切监视；3）根据患儿病情及家长意愿进行非随机干预，随访周期可较长，以利于观察患儿的个体化治疗情况；4）数据分析应从基线可比性、主要结局指标、亚组分析等方面对RWS结果进行合理的解读；5）在伦理学方面，慎重选择知情同意方式，严格审查风险受益、隐私保护，将更好地保护儿童ASD受试者。同时对真实医疗环境中儿童ASD针灸RWS进行了展望。 |
| English Summary: |
| Real-world study(RWS) is a study that collects，processes，analyzes，and interprets real clinical medical data from multiple perspectives.Because its results have inherent validity and external generalizability，it is increasingly valued in the field of acupuncture and moxibustion.By analyzing the suitability of RWS for acupuncture and moxibustion clinical research on Autism Spectrum Disorder(ASD) in children，it is believed that RWS holds significant value in medical research on children with ASD.However，several potential problems in conducting RWS on acupuncture and moxibustion for children with ASD were identified：1) Lack of high-quality acupuncture and moxibustion clinical research evidence; 2) Absence of a clinical evaluation system; 3) Disconnect between clinical research outcomes and translation.In response to these problems，potential solutions for conducting RWS on acupuncture and moxibustion for children with ASD were discussed：1) Research scenarios，study duration，and sample size should be determined based on real data; 2) Due to broad inclusion and exclusion criteria，subjects had broad representativeness，and close monitoring of compliance was unnecessary; 3) Non-randomized interventions should be conducted based on the child's condition and parental preferences，with longer follow-up periods to observe individualized treatment outcomes; 4) RWS results should be analyzed reasonably from aspects such as baseline comparability，primary outcome indicators，and subgroup analysis; 5) Ethically，informed consent methods should be selected cautiously，risk-benefit considerations and privacy protection should be rigorously reviewed to better safeguard child ASD participants.Additionally，the future prospects of conducting RWS on acupuncture and moxibustion for children with ASD in real medical environments were outlined. |
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