Adherence to study medication and visits: Data from the BABY HUG trial

Courtney D. Thornburg, Zora R. Rogers, Michael R. Jeng, Sohail R. Rana, Rathi V. Iyer, Lane Faughnan, Leann Hassen, Jennifer Marshall, Roy P. McDonald, Winfred C. Wang, Xiangke Huang, Renée C. Rees

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

Background. Subject retention and adherence are essential to maintain the power and validity of the Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG). We designed a study to assess adherence with study medication administration and study visits and to evaluate socioeconomic factors (SES) that may influence these measurements of adherence. These data are important for assessing impact of adherence on BABY HUG trial outcome and defining impact of SES on adherence. Methods. Each subject's median study medication (MedAd) and mean visit adherence (VAd) were evaluated. We examined associations of adherence with SES of participating families. Results. MedAd data were available on 153 of the 191 subjects who started randomized study medication. MedAd was 101.7% of volume prescribed, with 88.9% of subjects taking at least 80% of doses. VAd data were available on 185 of the 191 subjects who started randomized study medication. VAd was 97.3%, with 82.2% of subjects having no missed visits. During dose titration, subjects had on average 12.9% higher medication adherence than subjects who were on a stable dose and had less frequent study visits. MedAd and VAd were not significantly associated with SES. Conclusion. Subjects in the BABY HUG trial have had excellent adherence. SES was not associated with adherence, suggesting that SES should not be used as a criterion for enrolment in clinical trials. Additional efforts are needed to maintain medication adherence, particularly when the interval between scheduled visits increases. (ClinicalTrials.gov number, NCT00006400).

Original languageEnglish (US)
Pages (from-to)260-264
Number of pages5
JournalPediatric Blood and Cancer
Volume54
Issue number2
DOIs
StatePublished - Feb 2010

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Medication Adherence
Phase III Clinical Trials
Hydroxyurea
Clinical Trials
Pediatrics
Power (Psychology)

Keywords

  • Anti-sickling agents
  • Clinical trial
  • Non-adherence
  • Study retention

ASJC Scopus subject areas

  • Oncology
  • Pediatrics, Perinatology, and Child Health
  • Hematology

Cite this

Thornburg, C. D., Rogers, Z. R., Jeng, M. R., Rana, S. R., Iyer, R. V., Faughnan, L., ... Rees, R. C. (2010). Adherence to study medication and visits: Data from the BABY HUG trial. Pediatric Blood and Cancer, 54(2), 260-264. https://doi.org/10.1002/pbc.22324

Adherence to study medication and visits : Data from the BABY HUG trial. / Thornburg, Courtney D.; Rogers, Zora R.; Jeng, Michael R.; Rana, Sohail R.; Iyer, Rathi V.; Faughnan, Lane; Hassen, Leann; Marshall, Jennifer; McDonald, Roy P.; Wang, Winfred C.; Huang, Xiangke; Rees, Renée C.

In: Pediatric Blood and Cancer, Vol. 54, No. 2, 02.2010, p. 260-264.

Research output: Contribution to journalArticle

Thornburg, CD, Rogers, ZR, Jeng, MR, Rana, SR, Iyer, RV, Faughnan, L, Hassen, L, Marshall, J, McDonald, RP, Wang, WC, Huang, X & Rees, RC 2010, 'Adherence to study medication and visits: Data from the BABY HUG trial', Pediatric Blood and Cancer, vol. 54, no. 2, pp. 260-264. https://doi.org/10.1002/pbc.22324
Thornburg, Courtney D. ; Rogers, Zora R. ; Jeng, Michael R. ; Rana, Sohail R. ; Iyer, Rathi V. ; Faughnan, Lane ; Hassen, Leann ; Marshall, Jennifer ; McDonald, Roy P. ; Wang, Winfred C. ; Huang, Xiangke ; Rees, Renée C. / Adherence to study medication and visits : Data from the BABY HUG trial. In: Pediatric Blood and Cancer. 2010 ; Vol. 54, No. 2. pp. 260-264.
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abstract = "Background. Subject retention and adherence are essential to maintain the power and validity of the Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG). We designed a study to assess adherence with study medication administration and study visits and to evaluate socioeconomic factors (SES) that may influence these measurements of adherence. These data are important for assessing impact of adherence on BABY HUG trial outcome and defining impact of SES on adherence. Methods. Each subject's median study medication (MedAd) and mean visit adherence (VAd) were evaluated. We examined associations of adherence with SES of participating families. Results. MedAd data were available on 153 of the 191 subjects who started randomized study medication. MedAd was 101.7{\%} of volume prescribed, with 88.9{\%} of subjects taking at least 80{\%} of doses. VAd data were available on 185 of the 191 subjects who started randomized study medication. VAd was 97.3{\%}, with 82.2{\%} of subjects having no missed visits. During dose titration, subjects had on average 12.9{\%} higher medication adherence than subjects who were on a stable dose and had less frequent study visits. MedAd and VAd were not significantly associated with SES. Conclusion. Subjects in the BABY HUG trial have had excellent adherence. SES was not associated with adherence, suggesting that SES should not be used as a criterion for enrolment in clinical trials. Additional efforts are needed to maintain medication adherence, particularly when the interval between scheduled visits increases. (ClinicalTrials.gov number, NCT00006400).",
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AU - Iyer, Rathi V.

AU - Faughnan, Lane

AU - Hassen, Leann

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