Three week compared to seven week run-in period length and the assessment of pre-randomization adherence: A study within a trial

Autor: Jessica Tyrwhitt, Wen Liu, Joanne Wilkinson, Patrick B. Mark, Denis Xavier, Michael Walsh, Gordon H. Guyatt, Laura Sola, Vivekanand Jha, Martin Gallagher, Antonio L. Dans, Karthik K. Tennankore, Patrick Sheridan, Zuo Li, David Collister, Gilmar Reis, Philip J. Devereaux, Lawrence Mbuagbaw, Camilo Felix, Janak de Zoysa, Fei Yuan
Rok vydání: 2021
Předmět:
Zdroj: Contemporary clinical trials. 107
ISSN: 1559-2030
1551-7144
Popis: Background/aims:\ud \ud To examine how measuring adherence at 3 weeks by self-report and pill counts compares to measurements at 7 weeks in a pre-randomization run-in period.\ud \ud Methods:\ud \ud Study within a trial of an international parallel group randomized controlled trial (RCT) that compares spironolactone to placebo. Adults receiving dialysis enter an 8-week active run-in period with spironolactone. Adherence was assessed by both self-report and pill counts in a subgroup of participants at both 3 weeks and 7 weeks.\ud \ud Results:\ud \ud 332 participants entered the run-in period of which 166 had complete data. By self-report, 146/166 (94.0%) and 153/166 (92.2%) had at least 80% adherence at 3 and 7 weeks respectively (kappa = 0.27 (95% C.I. 0.16 to 0.38). By pill counts, the mean (SD) adherence was 96.5% (16.1%) and 92.4% (18.2%) at 3 and 7 weeks respectively (r = 0.32) with a mean (SD) difference of 3.1% (17.8%) and a 95% limit of agreement from −31.7% to +37.9%. The proportion of adherent participants by self-report and pill counts at 3 weeks agreed in 87.4% of participants (McNemar's p-value 0.58, kappa 0.11, p = 0.02) and at 7 weeks agreed in 92.2% (McNemar's p-value 0.82, kappa 0.47, p
Databáze: OpenAIRE
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