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A data-driven examination of which patients follow trial protocol.

Publication ,  Journal Article
Olsen, MK; Stechuchak, KM; Hung, A; Oddone, EZ; Damschroder, LJ; Edelman, D; Maciejewski, ML
Published in: Contemp Clin Trials Commun
September 2020

UNLABELLED: Protocol adherence in behavioral intervention clinical trials is critical to trial success. There is increasing interest in understanding which patients are more likely to adhere to trial protocols. The objective of this study was to demonstrate the use of a data-driven approach to explore patient characteristics associated with the lowest and highest rates of adherence in three trials assessing interventions targeting behaviors related to lifestyle and risk for cardiovascular disease. Each trial included a common set of baseline variables. Model-based recursive partitioning (MoB) was applied in each trial to identify participant characteristics of subgroups characterized by these baseline variables with differences in protocol adherence. Bootstrap resampling was conducted to provide optimism-corrected c-statistics of the final solutions. In the three trials, rates of protocol adherence varied from 56.9% to 87.5%. Evaluation of heterogeneity of protocol adherence via MoB in each trial resulted in trees with 2-4 subgroups based on splits of 1-3 variables. In two of the three trials, the first split was based on pain in the past week, and those reporting lower pain were less likely to be adherent. In one of these trials, the second and third splits were based on education and employment, where those with lower education levels and who were employed were less likely to be adherent. In the third trial, the two splits were based on smoking status and then marriage status, where smokers who were married were least likely to be adherent. Optimism-corrected c-statistics ranged from 0.54 to 0.63. Model-based recursive partitioning can be a useful approach to explore heterogeneity in protocol adherence in behavioral intervention trials. An important next step would be to assess whether patterns hold in other similar studies and samples. Identifying subgroups who are less likely to be adherent to an intervention can help inform modifications to the intervention to help tailor the intervention to these subgroups and increase future uptake and impact. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT01828567, NCT02360293, and NCT01838226.

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Published In

Contemp Clin Trials Commun

DOI

EISSN

2451-8654

Publication Date

September 2020

Volume

19

Start / End Page

100631

Location

Netherlands

Related Subject Headings

  • 32 Biomedical and clinical sciences
 

Citation

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Olsen, M. K., Stechuchak, K. M., Hung, A., Oddone, E. Z., Damschroder, L. J., Edelman, D., & Maciejewski, M. L. (2020). A data-driven examination of which patients follow trial protocol. Contemp Clin Trials Commun, 19, 100631. https://doi.org/10.1016/j.conctc.2020.100631
Olsen, Maren K., Karen M. Stechuchak, Anna Hung, Eugene Z. Oddone, Laura J. Damschroder, David Edelman, and Matthew L. Maciejewski. “A data-driven examination of which patients follow trial protocol.Contemp Clin Trials Commun 19 (September 2020): 100631. https://doi.org/10.1016/j.conctc.2020.100631.
Olsen MK, Stechuchak KM, Hung A, Oddone EZ, Damschroder LJ, Edelman D, et al. A data-driven examination of which patients follow trial protocol. Contemp Clin Trials Commun. 2020 Sep;19:100631.
Olsen, Maren K., et al. “A data-driven examination of which patients follow trial protocol.Contemp Clin Trials Commun, vol. 19, Sept. 2020, p. 100631. Pubmed, doi:10.1016/j.conctc.2020.100631.
Olsen MK, Stechuchak KM, Hung A, Oddone EZ, Damschroder LJ, Edelman D, Maciejewski ML. A data-driven examination of which patients follow trial protocol. Contemp Clin Trials Commun. 2020 Sep;19:100631.
Journal cover image

Published In

Contemp Clin Trials Commun

DOI

EISSN

2451-8654

Publication Date

September 2020

Volume

19

Start / End Page

100631

Location

Netherlands

Related Subject Headings

  • 32 Biomedical and clinical sciences