目的 建立眼保健操治疗儿童青少年近视的临床病例报告表(CRF),客观评价规范的眼保健操治疗儿童青少年近视的有效性和安全性.方法 以第六版中小学生眼保健操为基础,纳入2019年1月—2023年12月中国知网、万方数据库、中国生物医学文献数据库、PubMed、Web of Science、the Cochrance Library数据库中眼保健操与近视相关文献.采用Excel 2020软件对纳入的文献进行分析,总结其中存在的问题,针对发现的问题,并结合相关权威文献初步构建眼保健操CRF的主要内容.结果 (1)一般情况:最终纳入9篇文献,分析后总结出5个问题.(2)初步设定CRF:包括操作规范表、证候量化表、疗效判定标准、质量控制和观察时长5个部分,其中包括4个一级指标(主症)和6个二级指标(次症),主症与次症均分为轻、中、重3个等级,主症依次赋予2、4、6分,次症依次赋予1、2、3分;观察时间点为治疗后1、3、6、9、12个月.结论 本CRF可提高眼保健操临床研究的科学性和准确性,根据主、次症积分之和判断治疗前后病情的轻重及疗效,为眼保健操的推广应用以及临床研究者联合其他疗法防控近视提供参考价值.
Design of a Clinical Case Report Form for Eye Exercises in the Treatment of Myopia in Children and Adolescents
OBJECTIVE To establish a clinical case report form(CRF)for eye exercises in the treatment of myopia in children and adolescents,and to objectively evaluate the effectiveness and safety of standardized eye exercises in this population.METHODS Based on the sixth edition of eye exercises for primary and secondary school students,relevant literature on eye exercises and myopia from January 2019 to December 2023 was collected from databases including CNKI,Wanfang Database,China Biology Medicine disc(CBMdisc),PubMed,Web of Science,and the Cochrane Library.Excel 2020 software was used to analyze the literature,summarize the identified issues,and preliminarily construct the main content of the eye exercise CRF based on the identified problems and relevant authoritative literature.RESULTS(1)General situation:A total of nine articles were finally included,and five issues were identified after analysis.(2)Preliminary CRF design:The CRF includes five parts:operational standard table,syndrome quantification table,efficacy judgment criteria,quality control,and observation duration.It consists of four primary indicators(main symptoms)and six secondary indicators(sub-symptoms),each graded as mild,moderate,or severe,with scores of two,four,and six for main symptoms,and one,two,and three for sub-symptoms.Observation time points are set at one,three,six,nine,and 12 months after treatment.CONCLUSIONS This CRF can improve the scientificity and accuracy of clinical research on eye exercises,assess the severity and efficacy of the condition before and after treatment based on the total scores of main and sub-symptoms,and provide reference value for the promotion and application of eye exercises and the joint prevention and control of myopia with other therapies in clinical research.
eye exerciseschildren and adolescentsmyopiacase report formdesignappli-cation
NETL
NSTL
万方数据
