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Association of Protocol Complexity and Social Determinants of Health With Protocol Deviations in Surgical Trials of
Katherine N Cilley1, Anna C Schneider1, Marina A Malikova1
1Boston University, Chobanian and Avedisian School of Medicine, Boston Medical Center, Department of Surgery, Boston, Massachusetts.
Background:
Protocol deviations (PDs) in clinical trials can undermine data integrity and patient safety. While key risk indicators (KRIs) and protocol complexity have been linked to adherence, the influence of social determinants of health (SDoH) is less understood, particularly in medical device trials.
Materials And Methods:
A single-center, retrospective analysis was conducted of 229 patients in medical device trials. Relationships between PDs, KRIs, and SDoH were evaluated. KRIs included protocol amendments, amendments requiring informed consent changes, staff count and experience, treatment duration, and protocol complexity. SDoH factors included travel distance, insurance, body mass index, comorbidities, polypharmacy, household income, primary language, age, sex, and race. Analyses used Kendall's tau, Spearman correlation, and Kruskal-Wallis tests.
Results:
Longer treatment duration (r = 0.5355, P < 0.0001) and higher protocol complexity (r = 0.3881, P < 0.0001) moderately correlated with more PDs. Lower household income was also associated (r = -0.3131, P < 0.0001). Age and comorbidity count showed weak but significant associations. No significant links were found for protocol amendments, staff experience, or insurance. Spanish-speaking patients trended toward more PDs (P = 0.0565). Travel distance was inversely associated (r = -0.1359, P = 0.0399). Dropout was significantly related to older age (P < 0.0001), lower body mass index (P = 0.0004), more comorbidities, and greater protocol complexity (P < 0.0001).
Conclusions:
Protocol complexity, treatment duration, and certain SDoH, such as income, age, and comorbidity burden, are key drivers of PDs. Traditional KRIs, such as protocol amendments and staff experience, were not significant. Incorporating SDoH-focused strategies may improve adherence, retention, and trial quality.
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