Predictors of noncompliance in an oral contraceptive clinical trial

Carolyn L. Westhoff, Anupama T. Torgal, Elizabeth R. Mayeda, Noa'A Shimoni, Frank Z. Stanczyk, Malcolm C. Pike

Research output: Contribution to journalArticle

47 Citations (Scopus)

Abstract

Background: This analysis was conducted to identify the participant characteristics associated with noncompliance in an oral contraceptive (OC) clinical trial. Study Design: We studied ovarian suppression among normal-weight and obese women during the use of levonorgestrel (LNG)-containing combination OCs. Participants underwent twice weekly phlebotomy during the study cycle and received up to $360 for participation. Along with other study assays, we analyzed 903 specimens from 181 women to measure LNG to assess OC compliance. Consistently undetectable LNG levels indicated noncompliance. To evaluate predictors of OC noncompliance during this study, we compared the characteristics of compliant and noncompliant participants using multivariable logistic regression. We assigned each participant to a relative poverty level based on US census data; all other individual characteristics came directly from participant responses during the baseline interview. Results: One hundred eighty-one women completed the study; 31 were noncompliant (17%). In multivariable analyses, poverty level was the strongest predictor of noncompliance. Compared with those women in the quartile with the lowest level of residential poverty, other women were far more likely to be noncompliant, especially women in the quartile with the greatest prevalence of poverty (adjusted odds ratio, 8.4; 95% confidence interval, 1.5-46.1). Additional factors associated with noncompliance were education level less than a bachelor's degree and Hispanic ethnicity. Other demographic and psychometric measures were not associated with compliance. Conclusions: We found that noncompliance was strongly associated with residential poverty level, an indirect measure of individual income. In the United States, poverty is associated with female obesity, Hispanic ethnicity and low education, which were also associated here with noncompliance. Study compensation may motivate poor individuals to participate in clinical trials for income. Noncompliance in clinical trials, particularly differential noncompliance, jeopardizes study validity.

Original languageEnglish (US)
Pages (from-to)465-469
Number of pages5
JournalContraception
Volume85
Issue number5
DOIs
StatePublished - May 1 2012

Fingerprint

Poverty
Oral Contraceptives
Clinical Trials
Levonorgestrel
Hispanic Americans
Compliance
Education
Phlebotomy
Censuses
Psychometrics
Obesity
Logistic Models
Odds Ratio
Demography
Confidence Intervals
Interviews
Weights and Measures

All Science Journal Classification (ASJC) codes

  • Reproductive Medicine
  • Obstetrics and Gynecology

Keywords

  • Clinical trial
  • Noncompliance
  • Oral contraceptives

Cite this

Westhoff, C. L., Torgal, A. T., Mayeda, E. R., Shimoni, NA., Stanczyk, F. Z., & Pike, M. C. (2012). Predictors of noncompliance in an oral contraceptive clinical trial. Contraception, 85(5), 465-469. https://doi.org/10.1016/j.contraception.2011.09.019
Westhoff, Carolyn L. ; Torgal, Anupama T. ; Mayeda, Elizabeth R. ; Shimoni, Noa'A ; Stanczyk, Frank Z. ; Pike, Malcolm C. / Predictors of noncompliance in an oral contraceptive clinical trial. In: Contraception. 2012 ; Vol. 85, No. 5. pp. 465-469.
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Westhoff, CL, Torgal, AT, Mayeda, ER, Shimoni, NA, Stanczyk, FZ & Pike, MC 2012, 'Predictors of noncompliance in an oral contraceptive clinical trial', Contraception, vol. 85, no. 5, pp. 465-469. https://doi.org/10.1016/j.contraception.2011.09.019

Predictors of noncompliance in an oral contraceptive clinical trial. / Westhoff, Carolyn L.; Torgal, Anupama T.; Mayeda, Elizabeth R.; Shimoni, Noa'A; Stanczyk, Frank Z.; Pike, Malcolm C.

In: Contraception, Vol. 85, No. 5, 01.05.2012, p. 465-469.

Research output: Contribution to journalArticle

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AU - Westhoff, Carolyn L.

AU - Torgal, Anupama T.

AU - Mayeda, Elizabeth R.

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AU - Pike, Malcolm C.

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N2 - Background: This analysis was conducted to identify the participant characteristics associated with noncompliance in an oral contraceptive (OC) clinical trial. Study Design: We studied ovarian suppression among normal-weight and obese women during the use of levonorgestrel (LNG)-containing combination OCs. Participants underwent twice weekly phlebotomy during the study cycle and received up to $360 for participation. Along with other study assays, we analyzed 903 specimens from 181 women to measure LNG to assess OC compliance. Consistently undetectable LNG levels indicated noncompliance. To evaluate predictors of OC noncompliance during this study, we compared the characteristics of compliant and noncompliant participants using multivariable logistic regression. We assigned each participant to a relative poverty level based on US census data; all other individual characteristics came directly from participant responses during the baseline interview. Results: One hundred eighty-one women completed the study; 31 were noncompliant (17%). In multivariable analyses, poverty level was the strongest predictor of noncompliance. Compared with those women in the quartile with the lowest level of residential poverty, other women were far more likely to be noncompliant, especially women in the quartile with the greatest prevalence of poverty (adjusted odds ratio, 8.4; 95% confidence interval, 1.5-46.1). Additional factors associated with noncompliance were education level less than a bachelor's degree and Hispanic ethnicity. Other demographic and psychometric measures were not associated with compliance. Conclusions: We found that noncompliance was strongly associated with residential poverty level, an indirect measure of individual income. In the United States, poverty is associated with female obesity, Hispanic ethnicity and low education, which were also associated here with noncompliance. Study compensation may motivate poor individuals to participate in clinical trials for income. Noncompliance in clinical trials, particularly differential noncompliance, jeopardizes study validity.

AB - Background: This analysis was conducted to identify the participant characteristics associated with noncompliance in an oral contraceptive (OC) clinical trial. Study Design: We studied ovarian suppression among normal-weight and obese women during the use of levonorgestrel (LNG)-containing combination OCs. Participants underwent twice weekly phlebotomy during the study cycle and received up to $360 for participation. Along with other study assays, we analyzed 903 specimens from 181 women to measure LNG to assess OC compliance. Consistently undetectable LNG levels indicated noncompliance. To evaluate predictors of OC noncompliance during this study, we compared the characteristics of compliant and noncompliant participants using multivariable logistic regression. We assigned each participant to a relative poverty level based on US census data; all other individual characteristics came directly from participant responses during the baseline interview. Results: One hundred eighty-one women completed the study; 31 were noncompliant (17%). In multivariable analyses, poverty level was the strongest predictor of noncompliance. Compared with those women in the quartile with the lowest level of residential poverty, other women were far more likely to be noncompliant, especially women in the quartile with the greatest prevalence of poverty (adjusted odds ratio, 8.4; 95% confidence interval, 1.5-46.1). Additional factors associated with noncompliance were education level less than a bachelor's degree and Hispanic ethnicity. Other demographic and psychometric measures were not associated with compliance. Conclusions: We found that noncompliance was strongly associated with residential poverty level, an indirect measure of individual income. In the United States, poverty is associated with female obesity, Hispanic ethnicity and low education, which were also associated here with noncompliance. Study compensation may motivate poor individuals to participate in clinical trials for income. Noncompliance in clinical trials, particularly differential noncompliance, jeopardizes study validity.

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