J Hollada W Marfori A Tognolini W Speier A Adibi S G Ruehm
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Transcript of J Hollada W Marfori A Tognolini W Speier A Adibi S G Ruehm
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
• Time commitment
• Possible loss of confidentiality
• Personal opinions about research
• “Guinea Pig” complex
Radiological
• Contrast
• Pre-Medication (i.e. metoprolol/nitro)
• IV Placement
• Radiation
Steps to Trial Success
Understand Patients’ PerspectivesUnderstand Patients’ Perspectives
Customize Recruitment Strategy Customize Recruitment Strategy
Clinical Trial SuccessClinical Trial Success
Meet Recruitment GoalsMeet Recruitment Goals
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 using two-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-enrolled patients’ 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
Future Directions
• Compare factors influencing enrollment in other non-invasive cardiac imaging not involving ionizing radiation (i.e. MRI)
• Compare concerns of different patient populations
Acknowledgements
• 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
• Addition Study Team– Eric Yang, MD– William Suh, MD– Dinah Lorenzo