ArticleContemporary clinical trials communications2020
A data-driven examination of which patients follow trial protocol.
Article in Contemporary clinical trials communications, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Will Veterans Engage in Prevention After HRA-guided Shared Decision Making?
Randomized Controlled Trial of Group Prevention Coaching
Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans
Who cites it
1 citing paper in PubMed.
- Exploring differential response to an emergency department-based care transition intervention.The American journal of emergency medicine · 2021Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
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 registrationClinicalTrials.gov identifiers: NCT01828567, NCT02360293, and NCT01838226.
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What OpenQuestion holds
Registered trials
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