Hongying Kuang1, Susan Jin2, Tracey Thomas2, Lawrence Engmann3, Karl R Hansen4, Christos Coutifaris5, Peter Casson6, Gregory Christman7, Ruben Alvero8, Nanette Santoro8, Esther Eisenberg9, Michael P Diamond10, Richard S Legro11, Heping Zhang12. 1. Department of Obstetrics and Gynecology, First Affiliated Hospital and Heilongjiang University of Chinese Medicine, Harbin, People's Republic of China; Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut. 2. Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut. 3. Department of Obstetrics and Gynecology, University of Connecticut School of Medicine, Farmington, Connecticut. 4. Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma. 5. Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania. 6. Department of Obstetrics and Gynecology, University of Vermont, Burlington, Vermont. 7. Department of Obstetrics and Gynecology, Shands Hospital, University of Florida, Gainesville, Florida. 8. Department of Obstetrics and Gynecology, University of Colorado, Aurora, Colorado. 9. Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland. 10. Department of Obstetrics and Gynecology, Georgia Regents University, Augusta, Georgia. 11. Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, Pennsylvania. 12. Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut. Electronic address: Heping.Zhang@yale.edu.
Abstract
OBJECTIVE: To identify variables associated with retention (or dropout) in infertility clinical trials. Retention of subjects in randomized controlled clinical trials (RCTs) has received considerable attention, but there have been few consistent findings. DESIGN: Secondary analysis of data from RCTs. SETTING: Academic medical centers. PATIENT(S): Women with polycystic ovary syndrome (PCOS) or couples with unexplained infertility, aged 18-40 years. INTERVENTION(S): This study is not an intervention study, but the patients in the original RCTs were treated with any or combination of metformin, clomiphene citrate (CC), letrozole, and gonadotropins. MAIN OUTCOME MEASURE(S): Successful retention versus dropout during the RCTs. RESULT(S): Race, ethnicity, body mass index (BMI), insurance coverage, history of smoking, and history of alcohol use were significantly associated with retention whether they were considered in bivariate analyses or a multivariable logistic model. Specifically, white race, higher income, having graduate degrees, normal weight, better insurance coverage, nonsmokers, and those who reported current use of alcohol at the start of the trial, had higher retention rates. CONCLUSION(S): We identified several additive and persistent predictors of retention that can be used to guide the conduct of RCTs and improve the retention rate. Given the limitation of our association analysis, methodologically sound and theoretically grounded research are warranted so that high quality data can be collected to improve our understanding on the causes of dropout. CLINICAL TRIAL REGISTRATION NUMBER: NCT00068861 (PPCOS-I), NCT00719186 (PPCOS-II), and NCT01044862 (AMIGOS).
OBJECTIVE: To identify variables associated with retention (or dropout) in infertility clinical trials. Retention of subjects in randomized controlled clinical trials (RCTs) has received considerable attention, but there have been few consistent findings. DESIGN: Secondary analysis of data from RCTs. SETTING: Academic medical centers. PATIENT(S): Women with polycystic ovary syndrome (PCOS) or couples with unexplained infertility, aged 18-40 years. INTERVENTION(S): This study is not an intervention study, but the patients in the original RCTs were treated with any or combination of metformin, clomiphene citrate (CC), letrozole, and gonadotropins. MAIN OUTCOME MEASURE(S): Successful retention versus dropout during the RCTs. RESULT(S): Race, ethnicity, body mass index (BMI), insurance coverage, history of smoking, and history of alcohol use were significantly associated with retention whether they were considered in bivariate analyses or a multivariable logistic model. Specifically, white race, higher income, having graduate degrees, normal weight, better insurance coverage, nonsmokers, and those who reported current use of alcohol at the start of the trial, had higher retention rates. CONCLUSION(S): We identified several additive and persistent predictors of retention that can be used to guide the conduct of RCTs and improve the retention rate. Given the limitation of our association analysis, methodologically sound and theoretically grounded research are warranted so that high quality data can be collected to improve our understanding on the causes of dropout. CLINICAL TRIAL REGISTRATION NUMBER: NCT00068861 (PPCOS-I), NCT00719186 (PPCOS-II), and NCT01044862 (AMIGOS).
Authors: Michael P Diamond; Richard S Legro; Christos Coutifaris; Ruben Alvero; Randal D Robinson; Peter Casson; Gregory M Christman; Joel Ager; Hao Huang; Karl R Hansen; Valerie Baker; Rebecca Usadi; Aimee Seungdamrong; G Wright Bates; R Mitchell Rosen; Daniel Haisenleder; Stephen A Krawetz; Kurt Barnhart; J C Trussell; Dana Ohl; Yufeng Jin; Nanette Santoro; Esther Eisenberg; Heping Zhang Journal: N Engl J Med Date: 2015-09-24 Impact factor: 91.245
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Authors: S Sengupta; R P Strauss; R DeVellis; S C Quinn; B DeVellis; W B Ware Journal: J Acquir Immune Defic Syndr Date: 2000-07-01 Impact factor: 3.731
Authors: Richard S Legro; Robert G Brzyski; Michael P Diamond; Christos Coutifaris; William D Schlaff; Peter Casson; Gregory M Christman; Hao Huang; Qingshang Yan; Ruben Alvero; Daniel J Haisenleder; Kurt T Barnhart; G Wright Bates; Rebecca Usadi; Scott Lucidi; Valerie Baker; J C Trussell; Stephen A Krawetz; Peter Snyder; Dana Ohl; Nanette Santoro; Esther Eisenberg; Heping Zhang Journal: N Engl J Med Date: 2014-07-10 Impact factor: 91.245
Authors: Kathryn B Arnold; John A Hermos; Karen B Anderson; Lori Minasian; Catherine M Tangen; Jeffrey F Probstfield; Elise D Cook Journal: Cancer Epidemiol Biomarkers Prev Date: 2014-09-21 Impact factor: 4.254
Authors: Nanette Santoro; Esther Eisenberg; J C Trussell; LaTasha B Craig; Clarisa Gracia; Hao Huang; Ruben Alvero; Peter Casson; Gregory Christman; Christos Coutifaris; Michael Diamond; Susan Jin; Richard S Legro; Randal D Robinson; William D Schlaff; Heping Zhang Journal: Hum Reprod Date: 2016-07-07 Impact factor: 6.918
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