recruitment strategies for clinical trials in radiology: active vs. passive patient recruitment j...
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Recruitment Strategies for Clinical Trials in Radiology:
Active vs. Passive Patient Recruitment
J Hollada
S G Ruehm
A Tognolini
W Speier
L Ristow
W Marfori
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Rationale
• Patient recruitment for research studies is challenging
• Radiological studies involving potentially harmful ionizing radiation, such as computed tomography (CT), often defer patients from voluntary study enrollment
• The analysis of effective recruitment strategies is therefore of high interest
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Radiological Clinical Trials: Challenges
• Radiologists often have limited direct patient interaction
• Radiologists typically do not control patient referrals for imaging tests
• Radiological clinical trials are often highly dependent on other specialists to refer patients for enrollment
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Importance of Effective and Efficient Patient Recruitment
• Compliance with grant proposals and regulatory requirements is essential
• Exceeding proposed time frames increases costs of trial execution
• Inadequate approaches to patient recruitment may lead to a poor representation of the population under investigation introducing bias
• General: Important for advancement of knowledge, technology and overall public health
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Objective
To compare the impact of active and passive recruitment strategies on cardiac CT based
research studies
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Study Population
• Analysis of patient recruitment data over a 12-month period
• Total of 641 subjects:
– 279 females and 362 males (mean age: 66 +/- 10) were invited to participate in one of three IRB and HIPPA compliant cardiac CT research trials
• Recruitment strategies included both passive and active measures
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Active Recruitment Methods
• Research Staff– Research staff: Strategic review of medical records– Eligible subjects:
a) contact via letters/flyers by mail b) follow-up telephone calls to confirm receipt of letter/flyer
– Research staff explaining study to interested subjects who responded to the letters/flyers, or who expressed interest during the follow-up phone call
• Physician referrals of pre-qualified patients
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Passive Recruitment Methods
• Flyer Pick Up• Posters• Brochures
• Internet Postings/Ads– All 3 studies were posted on the UCLA radiology research page
• Word of Mouth– Patients referred family members, friends and colleagues
Placed in 5 different patient waiting areas and replenished monthly
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Results
• Of 767 potential study participants contacted, 108 (14.08%) were successfully enrolled in one of three imaging research studies (cardiac CT)
• Active Recruitment: Of 738 potential study participants, 92 (12.47%) patients were successfully enrolled
• Passive Recruitment: Of 26 potential study participants, 16 (61.54%) patients were successfully enrolled
- Please note: Percentages represent the known amount of patients who were passively recruited and qualified to participate. Number of patients who saw flyers/brochures/posters/internet ads and chose not to participate remains unknown
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Active Recruitment Results
• 85% of patients were actively recruited (92/108 subjects)
• Active Recruitment Strategies:
- Research Staff: 73% (79/108 subjects) successfully recruited
- Physician Referrals: 12% (13/108 subjects) successfully recruited
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Passive Recruitment Results
• 15% of subjects were passively recruited (16/108 subjects)
• Passive Recruitment Strategies:
– Word of Mouth: 56% (9/16 patients)
– Flyer Distribution: 44% (7/16 patients)
– Brochure Pick Up: 0% (0/16 patients)
– Internet Postings/Ads: 0% (0/16 patients)
– Posters: 0% (0/16 patients)
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Recruitment Strategies
• Active recruitment > Passive recruitment- Active recruitment strategies: enrollment of significantly more patients
per month than passive recruitment strategies (p<0.00001)
• Direct Recruitment via Research Staff > Passive Recruitment- The most effective method of direct recruitment via research staff
enrolled significantly more patients per month than all passive recruitment strategies together (p<0.00001)
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Patient Recruitment Summary Table
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Conclusions
• Active recruitment via dedicated research staff is a more effective method for recruiting patients to cardiovascular imaging CT research studies- Active patient recruitment allowed the questions and concerns of
potential subjects to be addressed whether via research staff or referring physicians
• Direct patient recruitment via research stass has the added bonus of providing a greater pool of potential patients that qualified for various radiological clinical trials
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Clinical Relevance
• Successful strategies for patient recruitment require research staff dedicated to active patient recruitment
• Continuous training of research staff involved in patient recruitment is expected to improve the efficiency of radiological trials
• Further analysis of patient recruitment data derived from large scale clinical radiological trials are warranted to further improve recruitment strategies
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Future Directions
• Cost Analysis of Recruitment Methods– Compare the cost effectiveness of each recruitment method to
further analyze what methods of recruitment work best for research studies involving cardiac CT