How Many Patients Do We Need? Predictors of Consent to Participate in Clinical Research Studies in Orthopaedic Trauma.
J Orthop Trauma
; 37(4): e170-e174, 2023 04 01.
Article
en En
| MEDLINE
| ID: mdl-36729512
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.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Ortopedia
Tipo de estudio:
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Humans
Idioma:
En
Revista:
J Orthop Trauma
Asunto de la revista:
ORTOPEDIA
/
TRAUMATOLOGIA
Año:
2023
Tipo del documento:
Article
Pais de publicación:
Estados Unidos