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

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

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

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

Objective To compare the impact of active and passive recruitment strategies on cardiac CT based research studies

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

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

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

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

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

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)

Recruitment Strategies Active recruitment > Passive recruitment -Active recruitment strategies: enrollment of significantly more patients per month than passive recruitment strategies (p< ) 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< )

Recruitment SummaryTotalMeanSD Active Recruitment Total Potential Patients Total Successfully Recruited Research Staff Physician Referrals Passive Recruitment Total Successfully Recruited Random Flyer Pick Up Word of Mouth Patient Recruitment Summary Table

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

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

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