Analyzing Adherence to Prenatal Supplement: Does Pill Count Measure Up?
Objective. To determine if adherence as measured by pill count would show a significant association with serum-based measures of adherence. Methods. Data were obtained from a prenatal vitamin D supplementation trial where subjects were stratified by race and randomized into three dosing groups: 400...
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| Format: | Article |
| Language: | English |
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Wiley
2010-01-01
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| Series: | International Journal of Endocrinology |
| Online Access: | http://dx.doi.org/10.1155/2010/631971 |
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| _version_ | 1832552316609232896 |
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| author | Kristie E. Appelgren Paul J. Nietert Thomas C. Hulsey Bruce W. Hollis Carol L. Wagner |
| author_facet | Kristie E. Appelgren Paul J. Nietert Thomas C. Hulsey Bruce W. Hollis Carol L. Wagner |
| author_sort | Kristie E. Appelgren |
| collection | DOAJ |
| description | Objective. To determine if adherence as measured by pill count would show a significant association with serum-based measures of adherence. Methods. Data were obtained from a prenatal vitamin D supplementation trial where subjects were stratified by race and randomized into three dosing groups: 400 (control), 2000, or 4000 IU vitamin D3/day. One measurement of adherence was obtained via pill counts remaining compared to a novel definition for adherence using serum 25-hydroxy-vitamin D (25-OH-D) levels (absolute change in 25(OH)D over the study period and the subject's steady-state variation in their 25(OH)D levels). A multivariate logistic regression model examined whether mean percent adherence by pill count was significantly associated with the adherence measure by serum metabolite levels. Results. Subjects' mean percentage of adherence by pill count was not a significant predictor of adherence by serum metabolite levels. This finding was robust across a series of sensitivity analyses. Conclusions. Based on our novel definition of adherence, pill count was not a reliable predictor of adherence to protocol, and calls into question how adherence is measured in clinical research. Our findings have implications regarding the determination of efficacy of medications under study and offer an alternative approach to measuring adherence of long half-life supplements/medications. |
| format | Article |
| id | doaj-art-b00de22dafa74efba3b164c350187e40 |
| institution | Kabale University |
| issn | 1687-8337 1687-8345 |
| language | English |
| publishDate | 2010-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | International Journal of Endocrinology |
| spelling | doaj-art-b00de22dafa74efba3b164c350187e402025-02-03T05:58:59ZengWileyInternational Journal of Endocrinology1687-83371687-83452010-01-01201010.1155/2010/631971631971Analyzing Adherence to Prenatal Supplement: Does Pill Count Measure Up?Kristie E. Appelgren0Paul J. Nietert1Thomas C. Hulsey2Bruce W. Hollis3Carol L. Wagner4Department of Pediatrics, Duke University, Durham, NC 27710, USADepartment of Biostatistics, Bioinformatics, and Epidemiology, Medical University of South Carolina, Charleston, SC 29425, USADivision of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC 29425, USADivision of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC 29425, USADivision of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC 29425, USAObjective. To determine if adherence as measured by pill count would show a significant association with serum-based measures of adherence. Methods. Data were obtained from a prenatal vitamin D supplementation trial where subjects were stratified by race and randomized into three dosing groups: 400 (control), 2000, or 4000 IU vitamin D3/day. One measurement of adherence was obtained via pill counts remaining compared to a novel definition for adherence using serum 25-hydroxy-vitamin D (25-OH-D) levels (absolute change in 25(OH)D over the study period and the subject's steady-state variation in their 25(OH)D levels). A multivariate logistic regression model examined whether mean percent adherence by pill count was significantly associated with the adherence measure by serum metabolite levels. Results. Subjects' mean percentage of adherence by pill count was not a significant predictor of adherence by serum metabolite levels. This finding was robust across a series of sensitivity analyses. Conclusions. Based on our novel definition of adherence, pill count was not a reliable predictor of adherence to protocol, and calls into question how adherence is measured in clinical research. Our findings have implications regarding the determination of efficacy of medications under study and offer an alternative approach to measuring adherence of long half-life supplements/medications.http://dx.doi.org/10.1155/2010/631971 |
| spellingShingle | Kristie E. Appelgren Paul J. Nietert Thomas C. Hulsey Bruce W. Hollis Carol L. Wagner Analyzing Adherence to Prenatal Supplement: Does Pill Count Measure Up? International Journal of Endocrinology |
| title | Analyzing Adherence to Prenatal Supplement: Does Pill Count Measure Up? |
| title_full | Analyzing Adherence to Prenatal Supplement: Does Pill Count Measure Up? |
| title_fullStr | Analyzing Adherence to Prenatal Supplement: Does Pill Count Measure Up? |
| title_full_unstemmed | Analyzing Adherence to Prenatal Supplement: Does Pill Count Measure Up? |
| title_short | Analyzing Adherence to Prenatal Supplement: Does Pill Count Measure Up? |
| title_sort | analyzing adherence to prenatal supplement does pill count measure up |
| url | http://dx.doi.org/10.1155/2010/631971 |
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