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Successful Patient Recruitment: What Drives or Deters Patient Participation in Radiological Research Studies?. J Hollada W Marfori A Tognolini W Speier A Adibi S G Ruehm. Clinical Trial Recruitment Challenges. General. Radiological. Contrast
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Successful Patient Recruitment: What Drives or Deters Patient Participation in Radiological Research Studies? J Hollada W Marfori A Tognolini W Speier A Adibi S G Ruehm
Clinical Trial Recruitment Challenges General Radiological Contrast Pre-Medication (i.e. metoprolol/nitro) IV Placement Radiation • Time commitment • Possible loss of confidentiality • Personal opinions about research • “Guinea Pig” complex
Steps to Trial Success Understand Patients’ Perspectives Customize Recruitment Strategy Meet Recruitment Goals Clinical Trial Success
Objective • To analyze factors influencing patient participation in cardiac CT studies • To customize recruitment strategies
Study Population • 3 ongoing clinical trials involving coronary CT angiography • 346 patients contacted over 9-month period • 134/346 patients randomly selected to participate in this IRB approved/HIPPA compliant study • 80/134 patients (mean age: 57 +/- 12) participated • 40/58 (12 female, 28 male) enrolled patients • 40/76 (20 female, 20 male) non-enrolled patients
Methods • Questionnaire evaluated 12 decision factors (5-point scale: 1=not at all important to 5=extremely important) • Average ratings were calculated and grouped into 3 main importance categories: low ( 2.5), medium (2.5-3.5), high ( 3.5) • Rating distributions were compared between groups usingtwo-sample Kolmogorov-Smirnov tests
Results: Enrolling Patients Low Medium High
Results: Non-Enrolling Patients Low Medium High
Significance of Results • Two Sample Kolmogorov-Smirnov test • Enrolled patients’ concerns • Additional health information (p = 0.002) • Free imaging (p < 0.001) • Altruistic benefit to society (p < 0.000001) • Non-enrolledpatients’ concerns • Possible pre-medication (p < 0.00001) • Time commitment (p < 0.000001) • Radiation (p = 0.005 )
Conclusion • Patients that decline clinical trial participation have different concerns from those that enroll • Perceived risk vs. perceived benefit • Insufficient knowledge of imaging
FutureDirections • Compare factors influencing enrollment in other non-invasive cardiac imaging not involving ionizing radiation (i.e. MRI) • Compare concerns of different patient populations
Acknowledgements • Addition Study Team • Eric Yang, MD • William Suh, MD • Dinah Lorenzo • Cardiovascular CT Team • Stefan Ruehm, MD • Antoinette Gomes, MD • Wanda Marfori, MD • Alessia Tognolini, MD • Cesar Arellano, MD • Ali Adibi, MD • Lindsey Ristow • Leila Mostafavi • William Speier, MS