BACKGROUND: Information comparing subjective and objective measurements of adherence to study medications and the effects of adherence on treatment-related differences in asthma clinical trials are limited. OBJECTIVE: We sought to compare subjective and objective measurements of children's adherence to inhaled corticosteroids or placebo and to determine whether adherence to study medications modified treatment-related differences in outcomes. METHODS: In an ancillary study conducted in 3 of 8 Childhood Asthma Management Program Clinical Centers, adherence was assessed by using self-reported and objective data in 5- to 12-year-old children with mild or moderate asthma who were randomly assigned to 200 μg of inhaled budesonide twice per day (n = 84) or placebo (n = 56) for 4 years. The κ statistic was used to evaluate agreement between self-reported adherence (daily diary cards) and objectively measured adherence (number of doses left in study inhalers). Multivariable analyses were used to determine whether adherence to study treatment modified treatment-related differences in outcomes. RESULTS: Adherence of less than 80% was seen in 75% of 140 children when adherence was measured objectively but only in 6% of children when measured by means of self-report. There was poor agreement between objective and subjective measurements of adherence of at least 80% (κ = 0.00; 95% CI, -0.05 to 0.04); self-reported adherence over the 4-year period generally overestimated objectively measured adherence (93.6% vs 60.8%, P < .0001). There was little evidence to indicate that adherence modified treatment-related differences in outcomes. CONCLUSION: Researchers should use objective rather than self-reported adherence data to identify clinical trial participants with low levels of adherence to study treatment.
RCT Entities:
BACKGROUND: Information comparing subjective and objective measurements of adherence to study medications and the effects of adherence on treatment-related differences in asthma clinical trials are limited. OBJECTIVE: We sought to compare subjective and objective measurements of children's adherence to inhaled corticosteroids or placebo and to determine whether adherence to study medications modified treatment-related differences in outcomes. METHODS: In an ancillary study conducted in 3 of 8 Childhood Asthma Management Program Clinical Centers, adherence was assessed by using self-reported and objective data in 5- to 12-year-old children with mild or moderate asthma who were randomly assigned to 200 μg of inhaled budesonide twice per day (n = 84) or placebo (n = 56) for 4 years. The κ statistic was used to evaluate agreement between self-reported adherence (daily diary cards) and objectively measured adherence (number of doses left in study inhalers). Multivariable analyses were used to determine whether adherence to study treatment modified treatment-related differences in outcomes. RESULTS: Adherence of less than 80% was seen in 75% of 140 children when adherence was measured objectively but only in 6% of children when measured by means of self-report. There was poor agreement between objective and subjective measurements of adherence of at least 80% (κ = 0.00; 95% CI, -0.05 to 0.04); self-reported adherence over the 4-year period generally overestimated objectively measured adherence (93.6% vs 60.8%, P < .0001). There was little evidence to indicate that adherence modified treatment-related differences in outcomes. CONCLUSION: Researchers should use objective rather than self-reported adherence data to identify clinical trial participants with low levels of adherence to study treatment.
Authors: Stanley Szefler; Scott Weiss; James Tonascia; N Franklin Adkinson; Bruce Bender; Reuben Cherniack; Michele Donithan; H William Kelly; Joseph Reisman; Gail G Shapiro; Alice L Sternberg; Robert Strunk; Virginia Taggart; Mark Van Natta; Robert Wise; Margaret Wu; Robert Zeiger Journal: N Engl J Med Date: 2000-10-12 Impact factor: 91.245
Authors: Romain A Pauwels; Søren Pedersen; William W Busse; Wan C Tan; Yu-Zhi Chen; Stefan V Ohlsson; Anders Ullman; Carl Johan Lamm; Paul M O'Byrne Journal: Lancet Date: 2003-03-29 Impact factor: 79.321
Authors: Giselle Mosnaim; Hong Li; Molly Martin; DeJuran Richardson; Paula Jo Belice; Elizabeth Avery; Norman Ryan; Bruce Bender; Lynda Powell Journal: J Allergy Clin Immunol Pract Date: 2013-08-30
Authors: Andrea J Apter; Fei Wan; Susan Reisine; Daniel K Bogen; Cynthia Rand; Bruce Bender; Ian M Bennett; Rodalyn Gonzalez; Chantel Priolo; Seema S Sonnad; Tyra Bryant-Stephens; Monica Ferguson; Rhonda C Boyd; Thomas Ten Have; Jason Roy Journal: J Asthma Date: 2013-07-17 Impact factor: 2.515
Authors: Kathryn Blake; James D Cury; Jobayer Hossain; Kelan Tantisira; Jianwei Wang; Edward Mougey; John Lima Journal: Pulm Pharmacol Ther Date: 2013-02-04 Impact factor: 3.410
Authors: Giselle Mosnaim; Hong Li; Molly Martin; Dejuran Richardson; Paula Jo Belice; Elizabeth Avery; Norman Ryan; Bruce Bender; Lynda Powell Journal: Ann Allergy Asthma Immunol Date: 2013-12-21 Impact factor: 6.347
Authors: Andrea J Apter; Fei Wan; Susan Reisine; Bruce Bender; Cynthia Rand; Daniel K Bogen; Ian M Bennett; Tyra Bryant-Stephens; Jason Roy; Rodalyn Gonzalez; Chantel Priolo; Thomas Ten Have; Knashawn H Morales Journal: J Allergy Clin Immunol Date: 2013-04-13 Impact factor: 10.793