Download Enrolling Patients

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
• Time commitment
• Contrast
• Possible loss of
confidentiality
• Pre-Medication
(i.e. metoprolol/nitro)
• Personal opinions about
research
• IV Placement
• “Guinea Pig” complex
• Radiation
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 using
two-sample Kolmogorov-Smirnov tests
Patient Survey
Benefits
Please rate the impact of the following
factors from 1 (not at all important) to 5
(extremely important) on your decision
to accept participation in the
radiological clinical trial that you were
initially contacted about:
The chance to obtain additional health
information
The opportunity to obtain free imaging
Altruistic benefit to society
Personal
Influence
Possible Side
Effects
Risks/ Discomforts
Monetary compensation
Concern regarding possible radiation
exposure
Role as an experimental patient
(aka "Guinea Pig")
Concern for possible loss of confidentiality
Concern for possible contrast or
investigational drug use
Concern for possible pre-medication
Concern for possible blood draw/ IV
placement
Personal availability and/or time
commitment
Personal medical opinion regarding your
own health
1
(Not at all
Important)
3
2
(Neither
(Somewhat
Important nor
Unimportant)
Unimportant)
4
(Somewhat
Important)
5
(Extremely
Important)
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 noninvasive cardiac imaging not involving ionizing radiation
(i.e. MRI)
• Compare concerns of different patient populations
Acknowledgements
• Cardiovascular CT Team
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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