Understanding Recruitment and Retention in Neurological Research

Abstract

Cognitive deficits in participants and the abrupt and traumatic way in which many neurological conditions present are two examples of the unique challenges in recruiting and retaining subjects with neurological injury for research studies. The purpose of this investigation was to identify obstacles to recruitment and retention in three ongoing research studies. These studies involve persons with neurological disorders across the continuum of care, from those newly diagnosed and with emergent presentation to those with more established, chronic neurological conditions. For the purpose of this analysis, we evaluated the effectiveness of the strategies employed to improve participation rates. The first study was an NIH funded project designed to identify biomarkers of vasospasm in persons (N=496) with aneurysmal subarachnoid hemorrhage (SAH) who presented to the neurovascular intensive care unit (NINR, RO1 NR004339). The purpose of the second study was to examine bio-behavioral interactions in family caregivers (N=59) of persons with a primary malignant brain tumor (PMBT) recruited in the community setting. The third project involved recruiting persons (N=1019) within an outpatient neurosurgical center to participate in a research registry. To determine differential effectiveness of strategies, consent and attrition rates were calculated at serial points over time in three studies and recruitment and retention strategies were compared. Sentinel time points in participants' disease trajectories played a key role in determining whether those who were approached to participate gave consent and were retained, particularly in the studies involving persons with aneurysmal SAH (consent = 85%; retention = 89%) and persons with PMBTs and their caregivers (consent = 68%; retention = 83%). In addition, several specific recruiter and interviewer training techniques were associated with higher recruitment and retention. Targeted strategies to improve participation rates are vital for neuroscience nurses involved in any aspect of clinical research, including those who conduct studies, assist with data collection, and recruit potential participants. IntroResearch has led to tremendous advances in the field of neuroscience. Basic science research has set the stage for technological, pharmaceutical, and behavioral interventions, which show a great deal of promise in improving the lives of persons with a neurologic disorder. The translation of basic science research to clinical practice, however, is dependent upon studies that are able to recruit and retain participants over time. Unfortunately, recruitment in neurological research is challenging due to potential barriers such as cognitive dysfunction in the participant and the often traumatic onset of neurologic insult. In other areas of health care NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author Manuscript research, participants are typically screened for cognitive dysfunction and those that do not meet criteria are excluded from participation. In neuroscie...

Analysis of start-up, retention, and adherence in ALS clinical trials

“…In published clinical trials, enrollment and retention data are routinely reported; however, factors affecting study start-up times, retention, and adherence to the protocol are rarely mentioned. 1,2 Conducting efficient clinical trials involves completing study start-up processes in a timely manner. This includes execution of the site contracts, obtaining institutional review board (IRB) approvals, and completing protocol, pharmacy, and outcomes trainings.…”

Barriers and Strategies in Recruitment for Bariatric Surgery Research

“…Publicity and advertisement of the study reaches all potential participants and stimulates interest in participation. 23 2. Direct one-on-one recruitment fosters interest, optimism, and confidence about participation.…”

“…23 6. Cultural sensitivity facilitates feelings of welcome and respect for potential participants of diverse backgrounds and allows recruitment of a diverse study sample.…”

“…Charts stuffed with research flier to prompt clinician to invite eligible patients to participate 29,30 Individual communication in the clinical setting 15,25 Emphasis on positive aspects of involvement including benefit to others through participation 31,32 Discussion of past research results that have benefited society and contributed to healthcare 21 Pointing out potential participant's value as expert in their situation 23 3. Informed consent process An interesting and non-threatening study title 22 Clear, direct, and simply stated consent form 16,22 Thorough verbal explanation to ensure comprehension 16,22 4.…”

“…The literature revealed four main themes that were particularly relevant: (1) fear of being a research ''subject,'' [13][14][15][16][17][18][19][20][21] (2) practical and logistical concerns, [14][15][16]18,[21][22][23] (3) regulations imposed by Institutional Review Boards (IRBs) and the Health Insurance Portability and Accountability Act (HIPAA), 19,[23][24][25][26] and (4) clinician and clinic staff attitudes regarding the study. 22,23,26,27 Fear of being a research subject is not limited to research that poses a risk for physical harm. In particular, fear of emotional distress can be a deterrent to research participation when the topic addressed is sensitive or stigmatizing.…”