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Participants Recruitment and Retention

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Participants Recruitment and Retention

Participant recruitment in the pediatric population has many challenges. As soon as the patients and the parents hears something in the line of research their first question is Are you going to draw blood from me? Is this going to hurt?” Establishing trust of the participant and parents increases motivation to participant recruitment, which is a process of persuasion. According to Tappen these are steps to completing participant recruitment and retention. Specify the desired sample and inclusion criteria. Develop a recruitment plan focused on potential sources of participants and their characteristics and preferences. Contact potential sources to obtain support and assistance. Disseminate information about the study to potential participants. Ask potential eligible people to become participants. Explain the study and get consent. Screen consented individuals to determine if they meet all inclusion and exclusion criteria. Enroll all involved and consented participants in designated role within the study. Retain enrolled participants through incentives, maintaining contact. Most of all report the findings of the study to completed participants and those who helped with recruitment.

Multiple reasons were identified why people voluntarily agree or disagree in participating in a research study and they range from monetary incentives to social rewards. The feeling of “doing good for the greater population and the feeling of appreciation” which means the perceived rewards outweighs the cost. A single study may not be have the capacity in offering all these but researchers are obligated to relate them to potential participants. Altruism many people are willing to participate in a study, which they believe, will help others. So that other people may not go through with what I’ve been through right now” is a simple reason to join. The following are other reasons why people are encouraged to participate in a study, curiosity, social reasons, information and diagnosis, and monetary incentives. Equipment and treatment, which is an opportunity to access new medication or equipment in interventional studies.

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Saldana, et al, reported in “Characteristics of Successful Recruitment in Prospective Pediatric Pharmacogenetic Studies” multiple factors impacts participants recruitment. More so in the pediatric population, no parents in their right mind would want their kids to be a guinea pigs of the researchers. Saldana and her team conducted their research in Cincinnati Children’s Hospital (CCHMC), which is a large midwestern pediatric academic medical center. This institution established a Pharmacogenetics Working Group in 2004, which is a multidisciplinary collaborative effort, focused on fundamental and translational pediatric pharmacogenetic research. The members of the group welcomed the participation of geneticist, clinical pharmacologist, pharmacists, statisticians, basic scientists, and physician scientists, from divisions throughout the medical center. Today the group provides intellectual resources for those involved in pharmacogenetic research (https://gps.cchmc.org).

Saldana’s team designed a structured survey focused on elements potentially involved with differential recruitment success. The survey has 21 study characteristics that were considered to potentially impact the likelihood of successful recruitment. They are categorized into the following; global infrastructure, general study characteristics and patient population characteristics. This team reported that the following features of studies with successful recruitment includes standardized clinical care, an ongoing team-patient relationship, severe and /or life-threatening outcome measures, study coordinators with experience in clinical research, a study medication with few or no alternative treatment options, and active involvement of the research team in clinical care. The team concluded that a scoring system for study characteristics may be useful to calculate the risk of failure for successful recruitment, allow discrimination among characteristics contributing to the risk, and permit study design alterations to improve likelihood of successful recruitment in pediatric pharmacogenetic studies (Saldana, et. al 2011). Barriers to Recruitment

The following are major barriers identified in participant’s recruitment irrelevance, inconvenience, cost, time and monetary cost, fear and feeling of too sick or stress are major hurdles for participant’s recruitment (Tappen, 2016). More so in the pediatric population which is reflected in our case study, “Family history of cancer and non-malignant diseases and risk of childhood acute lymphoblastic leukemia: A Childrenв’s Oncology Group Study”. The authors wrote that 17.6% of the parents refused to participate in the study and 5.2% did not participated due to other reasons. Saldana, et al wrote three items that are not advantageous, but not detrimental to recruitment of pediatric pharmacogenetic studies; clinician champion with protected time for research, mentors with clinical research experience and lead and/or onsite investigator experience in clinical research.

Potential research participants should be approached first by someone other than the members of the research team. Participants may feel obligated or coerced into participating in the study if the research team initially approaches them. The individual who first approached the potential research participant may have little or no interest in the study. This is a requirement of many IRBs and ethics committee in the United States. Retention Study participants are important to the researchers; a lot of time, energy and money were invested in the recruitment. The participants themselves invested their time and energy; hence careful monitoring of participants is crucial. These are some barriers identified why participants drop out of the study and they are the following; being tired, confused, frustrated and fatigued on poorly worded and repeated questions. Physical health problems and transportation to and from the testing site due to limited income were identified. Psychological stressors, painful procedures and embarrassing questions are major reasons why participants drop out of the study.

On the other hand there are many reasons why participants continues to be a part of the study until it is completed. A well-designed plan for tracking participants, like updates or newsletters on the progress of the study is one way to keep in touch. Participants are eager to know the results. At this time a well updated website is another medium of information. Personalized feedback is valuable in clinical research. The author was involved with My Life Our Future A Genotyping for Hemophilia A and B, when the result of the Genotyping is available the Hematologist and our Genetic Counselor explains what the result means to the patients and families. Genetic counseling at no cost are offered to our patients and families. Hence, our patients and families who participated in the study are satisfied and express eagerness when the results are available.

When the study is conducted in an accessible and comfortable location participants are more inclined to stay in the study. There are programs that offers a nominal fee for participation to compensate for the participants time and transportation, maybe a small gift is offered like a T-shirt, grocery bags with the company’s logo or a card on their birthday or holidays. Although it is proven that these are not incentives for participants to stay in the study. Respect for cultural values, beliefs and norms are important factor not just for study participants but the whole community at large. Most importantly maintaining communication with the study participants will keep them in the loop of the progress and end result. At this day and age it is easy to maintain communication with modern technology. Emails are available, websites or social medias that can be used as a mode of communication. Believe it or not there are still some of us who loves to open a physical birthday card or Christmas cards and feel the joy of being an important person because they remember the special day or on the holidays. To experience that joy, that the research team just did not see me as a research study participant but as an individual that has feelings matters most.

The success of the research study lies in the number of study participants. The number of positive characteristics in a study was related to the proportion of subjects consenting to the study: each positive characteristic in a study on average increased consent by 10.8%. These prominent characteristics indicated a solid clinical and research infrastructure is necessary for successful recruiting patients for pediatric pharmacogenetics. Future prospective studies may aim to characterize the importance of these characteristics and their contribution to recruitment (Saldana, 2011). The author of this paper was involved in My Life Our Future A Genotyping for patients with Hemophilia A and B. Our Hemophilia Treatment Center (HTC) was one of the many centers that was authorized to recruit research participants. We tested 76% of our patient population. Those patients who were not tested is due to parental refusal or the subjects does not meet the research criteria.

Conclusion

Participant recruitment is an art and science. Participants need to have an in-depth understanding of the study and one method of recruitment does not fit all. Several researchers reported several successful and unsuccessful recruitment strategies. This is a simple reminder to all the researchers that a written research proposal and IRB approved research study is only good in paper, better yet when there are participants who says yes and choose to stay with the study. Hence, recruitment and retention of participants are vital to any type of research. Strict adherence to the principles and standards of research proves to be a success even in pediatric research studies. That these group of population are vulnerable hence we as a member of the research team needs to adhere to the highest standards of clinical research, that the interest of our patients matters most. We, as members of the research team should be reminded everyday that the safety of the patients is above and beyond the objectivity of any clinical research study. Clinicians are the patient’s advocates and legally bound to uphold the rigorous principles and standard of research.

Reference:

Dana, J., Dawes, R., & Peterson, N. (2013). Belief in the unstructured interview: The persistence of an illusion. Judgment and Decision Making, 8(5), 512-n/a. www.ncbi.nlm.nih.gov/books/NBK144111/bin/annex8-fm1.pdf

Raanan, R., Gunier, R. B., Balmes, J. R., Beltran, A. J., Harley, K. G., Bradman, A., & Eskenazi, B. (2017). Elemental Sulfur Use and Associations with Pediatric Lung Function and Respiratory Symptoms in an Agricultural Community (California, USA).

Environmental Health Perspectives, 1251-8. doi:10.1289/EHP528 Richard, B. W. (2001). The effects of structured and unstructured interviewing techniques on applicant perceptions of accuracy, fairness, and general impression (Order No. 1406366). Available from ProQuest Central. (205392900). Retrieved from https://search.proquest.com/docview/205392900?accountid=193269

SaldaГ±a, S. N., Hooper, D. K., Froehlich, T. E., Campbell, K. M., Prows, C. A., Sadhasivam, S., Glauser, T. A. (2011). Characteristics of successful recruitment in prospective pediatric pharmacogenetic studies. Clinical Therapeutics, 33(12), 2072-81.

Tappen, R. M. (2016). Advanced nursing research: From theory to practice. Burlington, MA: Jones & Bartlett Learning.

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