Verification of Medication Adherence in Infertility Clinical Trial of PCOS_Chinese Journal of Evidence-Based Medicine

Authors：

 WANGYu ¹ , GAOJing-shu ¹ , LIUQiu-yang ¹ , YINLing-yu ¹ , CAIWang-yu ¹ , WANGRong ¹ , LIANGRui-ning ² , SUNYun ³ , HUANGDong-mei ⁴ , XUEHui-ying ⁵ ,  WUXiao-ke ¹

1. Department of Gynecology and Obstetrics, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China;
2. Department of Gynecology and Obstetrics, First Affiliated Hospital, Jiangxi University of Chinese Medicine, Nanchang 330000, China;
3. Department of Gynecology and Obstetrics, Wenzhou Hospital of Traditional Chinese Medicine, Wenzhou 325000, China;
4. Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China;
5. Department of Reproduction, Huaian Maternal and Child Health Hospital, Huaian 223001, China;

Corresponding author：

WUXiao-ke, Email: xiaokewu2002@vip.sina.com

Keywords：

Verification of medication compliance; Clomiphene citrate; Protocol optimization; Standardized training

DOI：

10.7507/1672-2531.20160223

Video：

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Medication adherence will directly affect the validity of primary endpoint indicator. This article discussed how to improve the medication adherence of clomiphene citrate based on PCOSact. We found that 20 (3+15+2) cases were "protocol violation" and there were cases in which researchers made mistakes while distributing medicine and guiding patients how to take medicine. Focusing on these problems we sumed up experience and emphasized the importance of medication compliance through the following aspects:(1) Improvement of insite supervision and remote monitoring; (2) Standardization training for research assistants; (3) Health education for subjects.

Citation： WANGYu, GAOJing-shu, LIUQiu-yang, YINLing-yu, CAIWang-yu, WANGRong, LIANGRui-ning, SUNYun, HUANGDong-mei, XUEHui-ying, WUXiao-ke. Verification of Medication Adherence in Infertility Clinical Trial of PCOS. Chinese Journal of Evidence-Based Medicine, 2016, 16(12): 1485-1488. doi: 10.7507/1672-2531.20160223 Copy

1.	饶琴文. 药物临床试验中受试者服药依从性的管理. 中国美容医学, 2012, 21(10):693-695.
2.	翁维良, 易丹辉. 中医临床研究质量控制与评估. 北京:人民卫生出版社, 2014:127-133.
3.	孙塑伦, 翁维良, 杨龙会. 中医临床研究实施过程质控与管理. 北京:中国中医药出版社, 2010:149-177.
4.	杨春梅, 黎艳艳, 李华荣. 临床试验药品管理存在的问题及其对策. 医药导报, 2011, 30(6):829-830.
5.	国家食品药品监督管理局. 药物临床试验质量管理规范. 北京:科学出版社, 2003:1-104.
6.	丁倩, 曹彩. 我国药物临床试验信息化建设初探. 中国新药杂志, 2012, 21(7):722-727.
7.	Monane M, Bohn RL, Gurwitz JH, et al. Compliance with antihypertensive therapy among elderly medicaid enrollees:the roles of age, gender, and race. Am J Public Health, 1996, 86(12):1805-1808.
8.	匡洪影, 张跃辉, 吴效科, 等. 针刺联合克罗米芬对多囊卵巢综合征妇女活产率影响临床研究设计与实施的探讨. 世界科学技术-中医药现代化, 2013, 5(15):864-867.
9.	Kuang H, Li Y, Wu X, et al. Acupuncture and Clomiphene Citrate for Live Birth in Polycystic Ovary Syndrome:Study Design of a Randomized Controlled Trial. Evid Based Complement Alternat Med, 2013:527303.
10.	Legro RS, Barnhart HX, Schlaff WD, et al. Clomiphene, Metformin, or Both for Infertility in the Polycystic Ovary Syndrome. N Engl J Med, 2007, 356(6):551-556.
11.	Legro RS, Brzyski RG, Diamond MP, et al. Letrozole versus clomiphene for infertility in the polycystic ovary syndrome. N Engl J Med, 2014, 371(2):119-129.
12.	施华芳, 姜冬九, 李乐之. 病人依从性的研究进展. 中华护理杂志, 2003, 38(2):134-136.
13.	Diamond MP, Legro RS, Coutifaris C, et al. Letrozole, Gonadotropin or Clomiphene for Unexplained Infertility. N Eng J Med, 2015, 373(13):1230-1240.
14.	van Berge Henegouwen MT, van Driel HF, Kasteleijn-Nolst Trenite DG. A patient diary as a tool to improve medicine compliance. Pharm World Sci, 1999, 21(1):21-24.
15.	Vaur L, Vaisse B, Genes N, et al. Use of electronic pill boxes to assess risk of poor treatment compliance:results of a large-scale trial. Am J Hypertens, 1999, 12(1):374-380.
16.	Andrejak M, Genes N, VaurL, et al. Electronic pill boxes in the evaluation of anti-hypertensive treatment compliance:Comparison of once daily versus twice daily regimen. Am J Hypertens, 2000, 13(2):184-190.
17.	Spooren D, Van Heeringen C, Jannes C. Strategies to increase compliance with outpatient aftercare among patients referred to a psychiatric emergency department:a multicentre controlled intervention study. Psychol Med, 1998, 28(4):949-956.
18.	Schedlbauer A, Schroeder K, Peters T, et al. Interventions to improve adherence to lipid lowering medication. Cochrane Database Syst Rev, 2010, 17(3):CD004371.
19.	李庆红, 陈静, 张萍, 等. 从质量管理角度看临床研究现状和发展趋势. 中国新药杂志, 2014, 23(8):871-878.
20.	蒋发烨, 吴一龙, 余细勇, 等. 药物临床试验机构对临床试验的组织管理和质量控制. 药事管理, 2011, 30(3):400-402.

1. 饶琴文. 药物临床试验中受试者服药依从性的管理. 中国美容医学, 2012, 21(10):693-695.
2. 翁维良, 易丹辉. 中医临床研究质量控制与评估. 北京:人民卫生出版社, 2014:127-133.
3. 孙塑伦, 翁维良, 杨龙会. 中医临床研究实施过程质控与管理. 北京:中国中医药出版社, 2010:149-177.
4. 杨春梅, 黎艳艳, 李华荣. 临床试验药品管理存在的问题及其对策. 医药导报, 2011, 30(6):829-830.
5. 国家食品药品监督管理局. 药物临床试验质量管理规范. 北京:科学出版社, 2003:1-104.
6. 丁倩, 曹彩. 我国药物临床试验信息化建设初探. 中国新药杂志, 2012, 21(7):722-727.
7. Monane M, Bohn RL, Gurwitz JH, et al. Compliance with antihypertensive therapy among elderly medicaid enrollees:the roles of age, gender, and race. Am J Public Health, 1996, 86(12):1805-1808.
8. 匡洪影, 张跃辉, 吴效科, 等. 针刺联合克罗米芬对多囊卵巢综合征妇女活产率影响临床研究设计与实施的探讨. 世界科学技术-中医药现代化, 2013, 5(15):864-867.
9. Kuang H, Li Y, Wu X, et al. Acupuncture and Clomiphene Citrate for Live Birth in Polycystic Ovary Syndrome:Study Design of a Randomized Controlled Trial. Evid Based Complement Alternat Med, 2013:527303.
10. Legro RS, Barnhart HX, Schlaff WD, et al. Clomiphene, Metformin, or Both for Infertility in the Polycystic Ovary Syndrome. N Engl J Med, 2007, 356(6):551-556.
11. Legro RS, Brzyski RG, Diamond MP, et al. Letrozole versus clomiphene for infertility in the polycystic ovary syndrome. N Engl J Med, 2014, 371(2):119-129.
12. 施华芳, 姜冬九, 李乐之. 病人依从性的研究进展. 中华护理杂志, 2003, 38(2):134-136.
13. Diamond MP, Legro RS, Coutifaris C, et al. Letrozole, Gonadotropin or Clomiphene for Unexplained Infertility. N Eng J Med, 2015, 373(13):1230-1240.
14. van Berge Henegouwen MT, van Driel HF, Kasteleijn-Nolst Trenite DG. A patient diary as a tool to improve medicine compliance. Pharm World Sci, 1999, 21(1):21-24.
15. Vaur L, Vaisse B, Genes N, et al. Use of electronic pill boxes to assess risk of poor treatment compliance:results of a large-scale trial. Am J Hypertens, 1999, 12(1):374-380.
16. Andrejak M, Genes N, VaurL, et al. Electronic pill boxes in the evaluation of anti-hypertensive treatment compliance:Comparison of once daily versus twice daily regimen. Am J Hypertens, 2000, 13(2):184-190.
17. Spooren D, Van Heeringen C, Jannes C. Strategies to increase compliance with outpatient aftercare among patients referred to a psychiatric emergency department:a multicentre controlled intervention study. Psychol Med, 1998, 28(4):949-956.
18. Schedlbauer A, Schroeder K, Peters T, et al. Interventions to improve adherence to lipid lowering medication. Cochrane Database Syst Rev, 2010, 17(3):CD004371.
19. 李庆红, 陈静, 张萍, 等. 从质量管理角度看临床研究现状和发展趋势. 中国新药杂志, 2014, 23(8):871-878.
20. 蒋发烨, 吴一龙, 余细勇, 等. 药物临床试验机构对临床试验的组织管理和质量控制. 药事管理, 2011, 30(3):400-402.

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