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