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

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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.	饒琴文. 藥物臨床試驗中受試者服藥依從性的管理. 中國美容醫學, 2012, 21(10):693-695.
2.	翁維良, 易丹輝. 中醫臨床研究質量控制與評估. 北京:人民衛生出版社, 2014:127-133.
3.	孫塑倫, 翁維良, 楊龍會. 中醫臨床研究實施過程質控與管理. 北京:中國中醫藥出版社, 2010:149-177.
4.	楊春梅, 黎艷艷, 李華榮. 臨床試驗藥品管理存在的問題及其對策. 醫藥導報, 2011, 30(6):829-830.
5.	國家食品藥品監督管理局. 藥物臨床試驗質量管理規范. 北京:科學出版社, 2003:1-104.
6.	丁倩, 曹彩. 我國藥物臨床試驗信息化建設初探. 中國新藥雜志, 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, 張躍輝, 吳效科, 等. 針刺聯合克羅米芬對多囊卵巢綜合征婦女活產率影響臨床研究設計與實施的探討. 世界科學技術-中醫藥現代化, 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.	施華芳, 姜冬九, 李樂之. 病人依從性的研究進展. 中華護理雜志, 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.	李慶紅, 陳靜, 張萍, 等. 從質量管理角度看臨床研究現狀和發展趨勢. 中國新藥雜志, 2014, 23(8):871-878.
20.	蔣發燁, 吳一龍, 余細勇, 等. 藥物臨床試驗機構對臨床試驗的組織管理和質量控制. 藥事管理, 2011, 30(3):400-402.

1. 饒琴文. 藥物臨床試驗中受試者服藥依從性的管理. 中國美容醫學, 2012, 21(10):693-695.
2. 翁維良, 易丹輝. 中醫臨床研究質量控制與評估. 北京:人民衛生出版社, 2014:127-133.
3. 孫塑倫, 翁維良, 楊龍會. 中醫臨床研究實施過程質控與管理. 北京:中國中醫藥出版社, 2010:149-177.
4. 楊春梅, 黎艷艷, 李華榮. 臨床試驗藥品管理存在的問題及其對策. 醫藥導報, 2011, 30(6):829-830.
5. 國家食品藥品監督管理局. 藥物臨床試驗質量管理規范. 北京:科學出版社, 2003:1-104.
6. 丁倩, 曹彩. 我國藥物臨床試驗信息化建設初探. 中國新藥雜志, 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, 張躍輝, 吳效科, 等. 針刺聯合克羅米芬對多囊卵巢綜合征婦女活產率影響臨床研究設計與實施的探討. 世界科學技術-中醫藥現代化, 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. 施華芳, 姜冬九, 李樂之. 病人依從性的研究進展. 中華護理雜志, 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. 李慶紅, 陳靜, 張萍, 等. 從質量管理角度看臨床研究現狀和發展趨勢. 中國新藥雜志, 2014, 23(8):871-878.
20. 蔣發燁, 吳一龍, 余細勇, 等. 藥物臨床試驗機構對臨床試驗的組織管理和質量控制. 藥事管理, 2011, 30(3):400-402.

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