基于CONSORT声明和STRICTA清单评价针刺防控儿童青少年近视随机对照试验的报告质量

doi:10.6040/j.issn.1673-3770.0.2024.174

摘要/Abstract

摘要： 目的评价国内外针刺防控儿童青少年近视的随机对照试验(randomized controlled trial, RCT)的报告质量。方法检索中国知网、万方、中国生物医学文献数据库、维普、 PubMed、Embase、The Cochrane Library等数据库中有关针刺治疗儿童青少年近视的RCT,检索时限为2001年1月至2023年12月,用临床试验报告标准声明(The Consolidated Standards of Reporting Trials, CONSORT)2010及针刺临床试验干预措施报告标准(Standards for Reporting Interventions in Clinical Trials of Acupuncture, STRICTA)对纳入文献的报告质量进行评价。结果初步检索获得中英文文献共1 136篇,经去重、筛选后最终纳入文献66篇,包括中文59篇、英文7篇。中英文文献 CONSORT 条目平均报告率为 43.8%和 62.9%。中文文献报告缺失的条目主要集中在“方法学” 、“结果” 和“其他信息” 3 方面。中英文 STRICTA 清单条目总报告率分别是63.2%和74.1%;纳入的中文文献只有 “所用穴位”报告率为100%,而英文文献有8个条目; “对何种治疗作了变动”、“治疗师背景”和“治疗场所和其他信息”3个条目的中文RCT报告率均<15%。结论中文针刺RCT的报告质量整体较低,未来研究者在报告针刺防控儿童青少年近视RCT研究结果时应严格按照CONSORT声明2010和STRICTA清单,以提高针刺治疗的RCT质量。

关键词: 针刺, 近视, 随机对照试验, 报告质量评价, CONSORT声明, STRICTA清单

Abstract: Objective To assess the reporting quality of randomized controlled trials(RCTs)on acupuncture for myopia in children and adolescents and provide suggestions to improve the quality of reporting clinical trials of acupuncture. Methods The databases CNKI, WanFang Data, SinoMed、VIP、PubMed、Embase and The Cochrane Library were searched for Chinese and English RCTs on acupuncture for myopia in children and adolescents from January 2001 to December 2023. The Expand Statement of Consolidated Standards of Reporting Trials 2010(CONSORT 2010)and Standards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA)were used to evaluate the reporting quality of the included studies. Results Totally, 1136 literatures were searched. After screening, 59 Chinese RCTs and 7 English RCTs were included. According to the CONSORT statement, the average reporting rate of the Chinese and English literature was 43.8% and 62.9%, respectively. The main missing items of Chinese RCTs focused on‘methodology’,‘results’,and ‘other information’. The reporting rates for the Chinese and English literatures of the STRICTA checklist were 63.2% and 74.1%. Only the item ‘Names of points used’was completely reported in the Chinese literature, while there were 8 items in English. The report rates for ‘The Extent to which the treatment was varied’、‘Practitioner background’、‘Setting and context of treatment’were less than 15%. Conclusion At present, the reporting quality of RCTs on prevention and control of acupuncture for myopia in children and adolescents in the Chinese literature is relatively low. In the future, researchers should follow the standards of CONSORT 2010 statements and STRICTA checklists to improve the quality of their studies.

Key words: Acupuncture, Myopia, Randomized controlled trial, Reporting quality evaluation, CONSORT statement, STRICTA checklists

中图分类号:

R778.1

王东芳,张清雨,宋继科,毕宏生. 基于CONSORT声明和STRICTA清单评价针刺防控儿童青少年近视随机对照试验的报告质量[J]. 山东大学耳鼻喉眼学报, 2024, 38(5): 66-79.

WANG Dongfang, ZHANG Qingyu, SONG Jike, BI Hongsheng. Assessment of reporting quality of randomized controlled trials on acupuncture preventing and controlling with myopia in children and adolescents based on CONSORT and STRICTA[J]. Journal of Otolaryngology and Ophthalmology of Shandong University, 2024, 38(5): 66-79.

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