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Trials

, 17:374

First Online: 29 July 2016Received: 19 March 2016Accepted: 21 June 2016DOI: 10.1186-s13063-016-1451-9

Cite this article as: Rees, J.R., Mott, L.A., Barry, E.L. et al. Trials 2016 17: 374. doi:10.1186-s13063-016-1451-9

Abstract

BackgroundEarly identification of participants at risk of run-in failure RIF may present opportunities to improve trial efficiency and generalizability.

MethodsWe conducted a partial factorial-design, randomized, controlled trial of calcium and vitamin D to prevent colorectal adenoma recurrence at 11 centers in the United States. At baseline, participants completed two self-administered questionnaires SAQs and a questionnaire administered by staff. Participants in the full factorial randomization calcium, vitamin D, both, or neither received a placebo during a 3-month single-blinded run-in; women electing to take calcium enrolled in a two-group randomization calcium with vitamin D, or calcium alone and received calcium during the run-in. Using logistic regression models, we examined baseline factors associated with RIF in three subgroups: men N = 1606 and women N = 301 in the full factorial randomization and women in the two-group randomization N = 666.

ResultsOverall, 314-2573 12 % participants failed run-in; 211 67 % took fewer than 80 % of their tablets poor adherence, and 103 33 % withdrew or were uncooperative. In multivariable models, 8- to 13-fold variation was seen by study center in odds of RIF risk in the two largest groups. In men, RIF decreased with age adjusted odds ratio OR per 5 years 0.85 95 % confidence interval, CI; 0.76–0.96 and was associated with being single OR 1.65 95 % CI; 1.10–2.47, not graduating from high school OR 2.77 95 % CI; 1.58–4.85, and missing SAQ data OR 1.97 1.40–2.76. Among women, RIF was associated primarily with health-related factors; RIF risk was lower with higher physical health score OR 0.73 95 % CI; 0.62–0.86 and baseline multivitamin use OR 0.44 95 % CI; 0.26–0.75. Women in the 5-year colonoscopy surveillance interval were at greater risk of RIF than those with 3-year follow-up OR 1.91 95 % CI; 1.08–3.37, and the number of prescription medicines taken was also positively correlated with RIF p = 0.03. Perceived toxicities during run-in were associated with 12- to 29-fold significantly increased odds of RIF.

ConclusionsThere were few common baseline predictors of run-in failure in the three randomization groups. However, heterogeneity in run-in failure associated with study center, and missing SAQ data reflect potential opportunities for intervention to improve trial efficiency and retention.

Trial registrationClinicalTrials.gov: NCT00153816. Registered September 2005.

KeywordsRandomized controlled trials Run-in Adherence Generalizability Electronic supplementary materialThe online version of this article doi:10.1186-s13063-016-1451-9 contains supplementary material, which is available to authorized users.

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Autor: Judy R. Rees - Leila A. Mott - Elizabeth L. Barry - John A. Baron - Jane C. Figueiredo - Douglas J. Robertson - Robert

Fuente: https://link.springer.com/







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