Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2005
Adherence assessment using medication weight in a phase IIb clinical trial of difluoromethylornithine for the chemoprevention of skin cancer.
Клиническое исследование II фазыСтатьяРандомизированное исследованиеПоддержка NIH: внешняя программаНазвание и аннотация: Перевод пока не подготовлен
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Hess Lisa M, Saboda Kathylynn, Malone Daniel C, Salasche Stuart, Warneke James, Alberts David S
Аннотация
OBJECTIVE: Adherence is a common and essential measurement in clinical trials. This study evaluates the association between participant self-reported study diary records and the weight of the medication vessel at each study visit, in the setting of a phase IIb topical chemoprevention trial.
METHODS: One hundred and twenty-four eligible participants were randomized to one of four arms [34 to difluoromethylornithine (DFMO) plus triamcinolone, 31 to DFMO plus placebo, 31 to placebo plus triamcinolone, and 28 to double placebo] for 6 months of treatment for actinic keratosis. Adherence was assessed at each clinic visit by weighing each tube of dispensed and returned medication and the participant's study diary.
RESULTS: Self-reported adherence was consistently higher than adherence measured by returned medication weight (96.5% versus 71.3%, 94.6% versus 82.4%, 95.3% versus 69.5%, and 95.8% versus 66.8% for DFMO, DFMO placebo, triamcinolone, and triamcinolone placebo, respectively; P < 0.001). Most participants (59.2%) recorded 100% adherence on the study diary; however, using the weight adherence, only 10.2% were completely adherent to the study regimen.
CONCLUSIONS: Self-reported diary measures seem to overestimate adherence when compared with weighing the returned medication vessel. It is recommended that future clinical trials involving topical applications incorporate medication weights as a primary measure of adherence because it is objective, quantitative, inexpensive, noninvasive, and easy to use.
METHODS: One hundred and twenty-four eligible participants were randomized to one of four arms [34 to difluoromethylornithine (DFMO) plus triamcinolone, 31 to DFMO plus placebo, 31 to placebo plus triamcinolone, and 28 to double placebo] for 6 months of treatment for actinic keratosis. Adherence was assessed at each clinic visit by weighing each tube of dispensed and returned medication and the participant's study diary.
RESULTS: Self-reported adherence was consistently higher than adherence measured by returned medication weight (96.5% versus 71.3%, 94.6% versus 82.4%, 95.3% versus 69.5%, and 95.8% versus 66.8% for DFMO, DFMO placebo, triamcinolone, and triamcinolone placebo, respectively; P < 0.001). Most participants (59.2%) recorded 100% adherence on the study diary; however, using the weight adherence, only 10.2% were completely adherent to the study regimen.
CONCLUSIONS: Self-reported diary measures seem to overestimate adherence when compared with weighing the returned medication vessel. It is recommended that future clinical trials involving topical applications incorporate medication weights as a primary measure of adherence because it is objective, quantitative, inexpensive, noninvasive, and easy to use.