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.	中華醫學會婦產科學分會絕經學組. 早發性卵巢功能不全的激素補充治療專家共識. 中華婦產科雜志, 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, 劉相云. 激素替代人工周期中藥療法治療卵巢早衰的臨床研究. 中外醫療, 2015, 34(27): 20-22.
5.	劉保延. 患者報告結局的測量. 北京: 人民衛生出版社, 2011: 25-35.
6.	曹卉娟, 劉建平. 中醫藥治療失眠臨床試驗中結局指標的選擇與報告. 中醫雜志, 2010, 51(5): 405-408.
7.	張明妍, 楊豐文, 李越, 等. 核心指標集報告規范(COS-STAR)介紹. 中國循證醫學雜志, 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.	谷鴻秋, 王楊, 李衛. Cochrane 偏倚風險評估工具在隨機對照研究 Meta 分析中的應用. 中國循環雜志, 2014, 29(2): 147-148.
11.	郭新峰, 賴世隆, 梁偉雄. 中醫藥臨床療效評價中結局指標的選擇與應用. 廣州中醫藥大學學報, 2002(4): 251-255.
12.	丁士龍, 姜敬運. 心率變異性分析是判斷慢性心力衰竭患者預后的獨立指標. 內科急危重癥雜志, 2001(2): 73-74.
13.	古芳, 徐艷文. 博洛尼亞標準——卵巢反應不良共識的解讀. 中國實用婦科與產科雜志, 2015, 31(8): 699-702.
14.	吳志南. 如何合理選擇炎性復合指標對肺癌患者的生存時間進行預測的研究. 濟南: 山東大學, 2019.
15.	楊洪艷, 王小云, 聶廣寧, 等. 絕經綜合征療效評定量表構建思路和循證研究探討. 循證醫學, 2007(3): 172-174, 192.
16.	郭正梅, 閻小妍, 姚晨. 兩個有序分類變量構建一個分類復合終點指標方法的模擬評價. 中國衛生統計, 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.	于長禾, 孫亞男, 何麗云, 等. 建立中醫藥臨床研究核心結局指標集. 中華中醫藥雜志, 2016, 31(7): 2526-2529.

1. 中華醫學會婦產科學分會絕經學組. 早發性卵巢功能不全的激素補充治療專家共識. 中華婦產科雜志, 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, 劉相云. 激素替代人工周期中藥療法治療卵巢早衰的臨床研究. 中外醫療, 2015, 34(27): 20-22.
5. 劉保延. 患者報告結局的測量. 北京: 人民衛生出版社, 2011: 25-35.
6. 曹卉娟, 劉建平. 中醫藥治療失眠臨床試驗中結局指標的選擇與報告. 中醫雜志, 2010, 51(5): 405-408.
7. 張明妍, 楊豐文, 李越, 等. 核心指標集報告規范(COS-STAR)介紹. 中國循證醫學雜志, 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. 谷鴻秋, 王楊, 李衛. Cochrane 偏倚風險評估工具在隨機對照研究 Meta 分析中的應用. 中國循環雜志, 2014, 29(2): 147-148.
11. 郭新峰, 賴世隆, 梁偉雄. 中醫藥臨床療效評價中結局指標的選擇與應用. 廣州中醫藥大學學報, 2002(4): 251-255.
12. 丁士龍, 姜敬運. 心率變異性分析是判斷慢性心力衰竭患者預后的獨立指標. 內科急危重癥雜志, 2001(2): 73-74.
13. 古芳, 徐艷文. 博洛尼亞標準——卵巢反應不良共識的解讀. 中國實用婦科與產科雜志, 2015, 31(8): 699-702.
14. 吳志南. 如何合理選擇炎性復合指標對肺癌患者的生存時間進行預測的研究. 濟南: 山東大學, 2019.
15. 楊洪艷, 王小云, 聶廣寧, 等. 絕經綜合征療效評定量表構建思路和循證研究探討. 循證醫學, 2007(3): 172-174, 192.
16. 郭正梅, 閻小妍, 姚晨. 兩個有序分類變量構建一個分類復合終點指標方法的模擬評價. 中國衛生統計, 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. 于長禾, 孫亞男, 何麗云, 等. 建立中醫藥臨床研究核心結局指標集. 中華中醫藥雜志, 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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