Barriers and Strategies for Recruiting Study Participants in Clinical Settings

New technologies challenge current dialysis treatment paradigms as devices become smaller, more portable, and increasingly used outside of the dialysis clinic. It is unclear how patients will view this care transition, and it will be important to consider patient and care partner perspectives during all aspects of development for novel dialysis therapies, from design and clinical trials to regulatory approval. To gain insight into this area, the Kidney Health Initiative (KHI)—a public-private partnership between the American Society of Nephrology, the US Food and Drug Administration, and nearly 80 member organizations and companies dedicated to enhancing patient safety and fostering innovation in kidney disease—convened a workshop of patients, care partners, and other kidney community stakeholders. The workshop included background presentations followed by focused small-group discussions in three areas (device design, clinical trials, and regulatory approval). Participants explored how to involve patients throughout the lifecycle of a medical device, including discussions of how patients can influence device design, assist in the planning and implementation of clinical trials, and provide input to impact regulatory decisions. Patients were engaged in the workshop discussion and interested in sharing their perspectives, but they recommended additional efforts around education, communication, and outreach in these areas.

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“…Investigators may also be concerned that contacting patients directly may be in conflict with current healthcare privacy laws. 30 …”

Section: Discussionmentioning

confidence: 99%

Stimulating Patient Engagement in Medical Device Development in Kidney Disease: A Report of a Kidney Health Initiative Workshop

Hurst

Chianchiano

Upchurch³

et al. 2017

American Journal of Kidney Diseases

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“…For clinical facilities, participating in a research project brings with it the implication of additional work (Sullivan-Bolyai et al, 2007). Our interlocutors in the clinics conveyed their non-participation by explaining that internal reorganizations and restructuring were imminent.…”

Section: Research Fieldmentioning

confidence: 99%

“…Fundamentally this procedure could have counteracted the skeptical attitude, as it is described in the literature, towards a research project led by nursing science (Slatin et al, 2004;Sullivan-Bolyai et al, 2007).…”

Section: Additional Factorsmentioning

confidence: 99%

Long-term outcomes of stroke rehabilitation: patients and informal caregivers

Rettke

Geschwindner

2014

Pflege

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“…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.…”

Section: Literature Reviewmentioning

confidence: 99%

Barriers and Strategies in Recruitment for Bariatric Surgery Research

Hulme

Land

McBride

2012

Bariatric Nursing and Surgical Patient Care

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Bariatric surgery patients present unique challenges for research recruitment. These include the stigma of obesity, sensitive psychosocial issues that may accompany obesity, and the many requirements of insurers before surgery is approved. Yet, little guidance is found in the literature on ways to improve recruitment success for bariatric surgery patients specifically. The purpose of this article is to describe the strategies we developed to overcome anticipated and unanticipated barriers to recruiting bariatric surgery patients for a prospective pilot study. First, we review the literature on barriers to recruitment and strategies to improve recruitment for clinical research projects in general. Pertinent barriers include fear of emotional distress, practical and logistical concerns for data collection, issues related to research regulations, and clinician attitudes regarding the study. Second, we demonstrate the ways in which successful strategies from the literature were incorporated into our recruitment plan. To help devise the recruitment plan, we categorized successful strategies into six recruitment steps that comprised the recruitment process for our pilot study. Third, we describe the ways in which our recruitment plan evolved to address unexpected challenges that emerged despite our systematic approach. We were able to complete the pilot study and maintain its integrity, but our initial goal of completing the study within a year was compromised. The information from this experience will help fill a gap in the literature, and can be used to improve the recruitment efficiency of bariatric surgery nurses and researchers who are involved in clinical research with bariatric surgery patients.

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Barriers and Strategies for Recruiting Study Participants in Clinical Settings

Cited by 64 publications

References 16 publications

Stimulating Patient Engagement in Medical Device Development in Kidney Disease: A Report of a Kidney Health Initiative Workshop

Stimulating Patient Engagement in Medical Device Development in Kidney Disease: A Report of a Kidney Health Initiative Workshop

Long-term outcomes of stroke rehabilitation: patients and informal caregivers

Barriers and Strategies in Recruitment for Bariatric Surgery Research

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