How Many Patients Do We Need? Predictors of Consent to Participate in Clinical Research Studies in Orthopaedic Trauma

Meghan K. Wally, Rachel Seymour, Tamar Roomian, Christine Churchill, Nikkole Haines, Joseph R. Hsu, Michael Bosse, Madhav A. Karunakar

Research output: Contribution to journalArticlepeer-review


Objectives:To characterize the recruitment rates at a Level I trauma center enroling for multiple prospective orthopaedic trauma research studies and identify patient-related and study-related predictors of consent.Design:We conducted a case-control study to identify predictors of study consent. The authors categorized studies based on intensity of the study intervention (low, intermediate, or high). A 2-level generalized linear model with random intercept for study was used to predict study consent.Setting:This analysis includes data from 10 federally funded studies conducted as part of a large, national consortium that were enroling patients in 2013-2014.Patients/Participants:Three hundred thirty-four patients were approached for at least 1 study and included in the analysis.Intervention:N/A.Main Outcome Measures:Consent to participate in the research study.Results:A total of 315 patients consented to be in a study (71% of approached patients). Consent rate varied by study (45%-95%). No patient characteristics (race, age, or sex) were associated with consent. Patients approached for studies of intermediate intensity were 83% less likely to consent (odds ratio = 0.17; 95% confidence interval: 0.04-0.67), and those approached for studies of high intensity were 91% less likely to consent (odds ratio = 0.09; 95% confidence interval: 0.03-0.32).Conclusion:Patient factors were not associated with consent. Study intensity is a major driver of consent rates. Studies of higher intensity will require the study team to approach up to twice as many patients as the target enrolment. This study provides a framework that can be used in study planning and determination of feasibility.

Original languageEnglish (US)
Pages (from-to)E170-E174
JournalJournal of orthopaedic trauma
Issue number4
StatePublished - Apr 1 2023

All Science Journal Classification (ASJC) codes

  • Surgery
  • Orthopedics and Sports Medicine


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