Status analysis of outcome indicators in randomized controlled studies of premature ovarian failure/primary ovarian insufficiency_West China Medical Journal

Authors：

WEN Zhaorui ¹ , LIU Jian ² , NIE Guangning ² , LI Yang ² ,  YANG Hongyan ²

1. The Second Clinical Medical College, Guangzhou University of Traditional Chinese Medicine, Guangzhou, Guangdong 510006, P. R. China;
2. Department of Gynaecology, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong 510120, P. R. China;

Corresponding author：

YANG Hongyan, Email: dryanghongyan@163.com

Keywords：

Premature ovarian failure; Primary ovarian insufficiency; Randomized controlled trial; Outcome indicator; Analysis and evaluation

DOI：

10.7507/1002-0179.202011254

Video：

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Objective To analyze the status quo of outcome indicators in the randomized controlled trials (RCTs) of premature ovarian failure (POF)/primary ovarian insufficiency (POI) published at home and abroad, and provide a sufficient basis for the selection of outcome indicators in related studies in the future.Methods China National Knowledge Infrastructure, Chongqing VIP Data, Wanfang Data, SinoMed, PubMed, the Cochrane Library, and Embase were searched for RCT articles of POF/POI published between the establishment of the databases and June 2021. Two researchers independently screened and extracted the literature, and finally summarized the outcome indicators of the included studies.Results A total of 186 articles meeting the inclusion criteria were selected, including 180 articles in Chinese and 6 articles in English. The choice of outcome indicators was diverse. Of the 186 articles, 2 Chinese articles and 1 English article used primary and secondary outcome indicators; 19 Chinese articles and 4 English articles used independent indicators, 4 Chinese articles used composite indicators, and 157 Chinese articles and 2 English articles used both independent indicators and composite indicators.Conclusions The selection and use of outcome indicators in clinical RCTs of POF/POI are not standardized, and there are problems such as neglect of primary and secondary outcome indicators, and lack of standards for the selection of clinical research outcome indicators. As a result, the credibility of the curative effect is reduced, and the results of similar studies cannot be combined and compared.

Citation： WEN Zhaorui, LIU Jian, NIE Guangning, LI Yang, YANG Hongyan. Status analysis of outcome indicators in randomized controlled studies of premature ovarian failure/primary ovarian insufficiency. West China Medical Journal, 2021, 36(8): 1093-1101. doi: 10.7507/1002-0179.202011254 Copy

1.	中华医学会妇产科学分会绝经学组. 早发性卵巢功能不全的激素补充治疗专家共识. 中华妇产科杂志, 2016, 51(12): 881-886.
2.	European Society for Human Reproduction and Embryology (ESHRE) Guideline Group on POI, Webber L, Davies M, et al. ESHRE guideline: management of women with premature ovarian insufficiency. Hum Reprod, 2016, 31(5): 926-937.
3.	Baber RJ, Panay N, Fenton A, et al. 2016 IMS recommendations on women’s midlife health and menopause hormone therapy. Climacteric, 2016, 19(2): 109-150.
4.	周瑞秀, 刘相云. 激素替代人工周期中药疗法治疗卵巢早衰的临床研究. 中外医疗, 2015, 34(27): 20-22.
5.	刘保延. 患者报告结局的测量. 北京: 人民卫生出版社, 2011: 25-35.
6.	曹卉娟, 刘建平. 中医药治疗失眠临床试验中结局指标的选择与报告. 中医杂志, 2010, 51(5): 405-408.
7.	张明妍, 杨丰文, 李越, 等. 核心指标集报告规范(COS-STAR)介绍. 中国循证医学杂志, 2017, 17(7): 857-861.
8.	Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet, 2009, 374(9683): 86-89.
9.	Hirsch BR, Califf RM, Cheng SK, et al. Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials. gov. JAMA Intern Med, 2013, 173(11): 972-979.
10.	谷鸿秋, 王杨, 李卫. Cochrane 偏倚风险评估工具在随机对照研究 Meta 分析中的应用. 中国循环杂志, 2014, 29(2): 147-148.
11.	郭新峰, 赖世隆, 梁伟雄. 中医药临床疗效评价中结局指标的选择与应用. 广州中医药大学学报, 2002(4): 251-255.
12.	丁士龙, 姜敬运. 心率变异性分析是判断慢性心力衰竭患者预后的独立指标. 内科急危重症杂志, 2001(2): 73-74.
13.	古芳, 徐艳文. 博洛尼亚标准——卵巢反应不良共识的解读. 中国实用妇科与产科杂志, 2015, 31(8): 699-702.
14.	吴志南. 如何合理选择炎性复合指标对肺癌患者的生存时间进行预测的研究. 济南: 山东大学, 2019.
15.	杨洪艳, 王小云, 聂广宁, 等. 绝经综合征疗效评定量表构建思路和循证研究探讨. 循证医学, 2007(3): 172-174, 192.
16.	郭正梅, 阎小妍, 姚晨. 两个有序分类变量构建一个分类复合终点指标方法的模拟评价. 中国卫生统计, 2014, 31(2): 245-250.
17.	Williamson PR, Altman DG, Blazeby JM, et al. Driving up the quality and relevance of research through the use of agreed core outcomes. J Health Serv Res Policy, 2012, 17(1): 1-2.
18.	于长禾, 孙亚男, 何丽云, 等. 建立中医药临床研究核心结局指标集. 中华中医药杂志, 2016, 31(7): 2526-2529.

1. 中华医学会妇产科学分会绝经学组. 早发性卵巢功能不全的激素补充治疗专家共识. 中华妇产科杂志, 2016, 51(12): 881-886.
2. European Society for Human Reproduction and Embryology (ESHRE) Guideline Group on POI, Webber L, Davies M, et al. ESHRE guideline: management of women with premature ovarian insufficiency. Hum Reprod, 2016, 31(5): 926-937.
3. Baber RJ, Panay N, Fenton A, et al. 2016 IMS recommendations on women’s midlife health and menopause hormone therapy. Climacteric, 2016, 19(2): 109-150.
4. 周瑞秀, 刘相云. 激素替代人工周期中药疗法治疗卵巢早衰的临床研究. 中外医疗, 2015, 34(27): 20-22.
5. 刘保延. 患者报告结局的测量. 北京: 人民卫生出版社, 2011: 25-35.
6. 曹卉娟, 刘建平. 中医药治疗失眠临床试验中结局指标的选择与报告. 中医杂志, 2010, 51(5): 405-408.
7. 张明妍, 杨丰文, 李越, 等. 核心指标集报告规范(COS-STAR)介绍. 中国循证医学杂志, 2017, 17(7): 857-861.
8. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet, 2009, 374(9683): 86-89.
9. Hirsch BR, Califf RM, Cheng SK, et al. Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials. gov. JAMA Intern Med, 2013, 173(11): 972-979.
10. 谷鸿秋, 王杨, 李卫. Cochrane 偏倚风险评估工具在随机对照研究 Meta 分析中的应用. 中国循环杂志, 2014, 29(2): 147-148.
11. 郭新峰, 赖世隆, 梁伟雄. 中医药临床疗效评价中结局指标的选择与应用. 广州中医药大学学报, 2002(4): 251-255.
12. 丁士龙, 姜敬运. 心率变异性分析是判断慢性心力衰竭患者预后的独立指标. 内科急危重症杂志, 2001(2): 73-74.
13. 古芳, 徐艳文. 博洛尼亚标准——卵巢反应不良共识的解读. 中国实用妇科与产科杂志, 2015, 31(8): 699-702.
14. 吴志南. 如何合理选择炎性复合指标对肺癌患者的生存时间进行预测的研究. 济南: 山东大学, 2019.
15. 杨洪艳, 王小云, 聂广宁, 等. 绝经综合征疗效评定量表构建思路和循证研究探讨. 循证医学, 2007(3): 172-174, 192.
16. 郭正梅, 阎小妍, 姚晨. 两个有序分类变量构建一个分类复合终点指标方法的模拟评价. 中国卫生统计, 2014, 31(2): 245-250.
17. Williamson PR, Altman DG, Blazeby JM, et al. Driving up the quality and relevance of research through the use of agreed core outcomes. J Health Serv Res Policy, 2012, 17(1): 1-2.
18. 于长禾, 孙亚男, 何丽云, 等. 建立中医药临床研究核心结局指标集. 中华中医药杂志, 2016, 31(7): 2526-2529.

West China Medical Journal

Status analysis of outcome indicators in randomized controlled studies of premature ovarian failure/primary ovarian insufficiency

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