Recruitment of research subjects

Ask An Expert Edited by Patricia A. Martin, PhD, RN Patricia A. Martin, PhD, RN, is Director for Nursing Research at Wright State University---Miami Valley School of Nursing, Dayton, OH 45435.

Recruitment of Research Subjects

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RACTICING NURSES often ask about recruitment, both for their own research and when assisting others. What are some of the issues to consider when recruiting subjects? Certainly informed consent is one critical issue, but there are others, which are the focus of this article. Four major issues exist: (a) population characteristics that assist or deter recruitment efforts and those that contribute to an increased vulnerability of the subjects (Murphy, 1993; Raudonis, 1992; Souder, 1992); (b) recruitment role conflict between the roles of practitioner and researcher (Davis, 1989; Raudonis, 1992; Rempusheski, 1991); (c) participation motivation, what motivates, and how to tap in to those motivators (Murphy, 1993; Newberg, Holland, & Pearce, 1992); and (d) time-frame bartiers to recruitment plans. Each of these issues will be addressed independently, although some overlap will be evident. Size, both an estimation of the population size and determination of planned sample size, is an area of discussion needed as background to these recruitment issues. A solid realistic and, if possible, empirically based estimation of the available population is critical to recruitment plans (Ashery & McAuliffe, 1992; Diekmann & Smith, 1989). Power estimations should be used for sample-size determinations in quantitative studies in which inferential statistics are planned. Although size is not the thrust of this article, an adequate size and the representativeness of the sample are the foundation of recruitment concerns. Recruitment efforts are directed toward acquiring a sample that is both of adequate size and representative of the target population to answer the research question. Because several researchers have documented the difCopyright © 1995 by W.B. Saunders Company 0897-1897/95/0801-0011 $5.00/0

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ference between samples selected at random and those composed of volunteers (Diekmann & Smith, 1992; Wewers & Ahijevych, 1990), it is important in many studies to recruit those selected and not use a sample of convenience. This article addresses the issues of population characteristics, recruiter role conflicts, participation motivation, and time-frame barriers that present challenges to recruitment

Population Characteristics Although some fears regarding being a guinea pig are shared by many potential subjects (Ashery & McAuliffe, 1992), certain specific population characteristics add other challenges to the recruitment effort. The population characteristics that assist or deter recruitment efforts are sometimes not evident to new recruiters. Several researchers have found certain populations especially challenging to recruit, for example, the elderly, certain ethnic groups, and groups with certain inclusion criteria. The Williams article (1993) gives an excellent report on what some elderly subjects and their families think about research with the elderly. These respondents were fairly positive about theoretical participation; however, other researchers have reported difficulty with the recruitment of the elderly (McNeely & Clements, 1994; Souder, 1992). Lay workers may be cost-effective in recruitment of special populations that cannot identify with the research team. Sung et al. (1992) successfully used lay health workers to recruit poor black women into a cancer-screening program. The reasons individuals are selected for recruitment may be traits about which the potential subject is sensitive, for example, age, failed compliance in the past, or an increased risk for a condition to which the person prefers to deny any risk. Stevenson (personal cornApplied Nursing Research, Vol. 8, No. 1 (February), 1995: pp. 59-54

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munication, October, 1994) reported difficulty in recruitment of elderly hospitalized patients for a falls-prevention study at Miami Valley Hospital that she attributed partially to not wanting to be seen as at risk for falling. A person who is denying or does not like to think about a certain condition may not want to participate in a study on that topic. In contrast, a subject who will get "special" help may be more willing to participate. In the past, patients may have been well enough to be bored or submissive enough to accommodate any request when hospitalized. Today's patients are usually very ill during their hospital time, which may limit active participation in some research to the post-hospitalization period. In addition, health care clients and their families have assumed a much more questioning stance to all requests, especially when it comes to volunteering. Most nursing studies do not offer potential cure in a no-hope situation, which is therefore not a winwin situation for subject and researcher. Marketing a research project to potential subjects when the research participation offers little direct reward to the subject is challenging. Added to the challenge of a resistant population, is the "watchdog," the institutional review board (IRB), who is watchful that the recruitment efforts include no exaggerations or false claims--truth in advertising. Captive individuals, identified as including prisoners and the terminally ill (Raudonis, 1992), children (Clark, 1993; Everson-Bates, 1988), and mental health clients (Schulberg et al., 1993; Dilonardo, Kendrick, & Vivaldo, 1993) have been clearly identified as vulnerable populations for which special care in recruitment must be taken. However, nurses are beginning to recognize that as nurses, they share emotionally highly charged life events with people that may make these people more vulnerable to unintentional, but no less real, coercion. Birth and death are two extreme examples. Because assisting people in these special times is central to the profession of nursing, nurse researchers seek to bring increased understanding to these experiences. Researchers do not have an unbiased view of their own work; therefore, a careful peer review is essential to avoid breaking the sacred trust inherent in these emotionally charged life event situations. What is the most ethical way to recruit subjects for studies of delicate situations? How does the role of the recruiter change the situation?

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Recruiter Role Conflicts When the nurse is in the role of health care provider, the client believes the nurse is offering services that are specifically "client centered," but the nurse as researcher has "knowledge as the focus." Rempusheski (1991) notes that nurses play a variety of roles during research with their patients: watchdog, educator, and facilitator. Johansen, Mayer, and Hoover (1991) discuss the differentiation of these health care provider and researcher roles in clinical trials, and they specifically noted the conflicts in responsibilities for the caregiver who is also responsible for research activities. The nurse researcher who is also a caregiver certainly intends no harm; however, the client may not know the nurse's focus has shifted and could later feel neglected or tricked. If there is truly no tangible benefit to the client, how can the nurse both market the study to a potential subject and advocate for the client? When the person is both a client and a subject, will the researcher "hear" reluctance or second thoughts on the part of the client, which is expected of a patient advocate (Carico & Harrison, 1990)? Paternostro (1991) and Davis (1989) both specify the difficulty nurses feel when subjects (volunteers) experienced discomfort because of research participation. These are true dilemmas with no clear single answer, but role conflicts and associated dilemmas need important consideration. In at least one study (B. Stevenson, personal communication, October 1994), nurses recruited for their nurse caring behaviors from among patients assigned to other nurses and did not recruit their own patients to avoid trading on their nurse-patient relationship. Nurses in several hospitals in Dayton have aided Carol Holdcraft, a faculty member at Wright State University-Miami Valley School of Nursing, by briefly introducing her project and securing their patient's permission for Holdcraft to later contact the patient (personal communication, October 1994). This role of preliminary subject identification is in keeping with the nurses' overall relationship with their patients and has helped Holdcraft in her recruitment of women with myocardial infarction. Nurses often help identify potential subjects who meet inclusion criteria so that researchers are approaching viable candidates when they "pitch" their study in a recruitment effort. Again, this preliminary recruitment activity seems to have little

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chance of violating client confidence while providing valuable assistance to the progress of nursing science. A client's nurse should not have the responsibility for completely briefing the subject about study participation and the details of the study. The complete briefing, the foundation of informed consent, is the research team's responsibility, whether it is a nursing study or another profession's study. As noted earlier, it becomes confusing to client subjects when their caregiver is also the researcher or is active in study recruitment. Confusion is also a possibility for the nurse who is trying to consider client motivation, both from the perspective of advocate and the perspective of subject recruitment. Participation Motivation Newberg, Holland, and Pearce (1992) identified three motivators as important in recruitment: altruism, trust in the research team, and the perception about the importance of the research. Souder (1992) identified eight motivators for recruiting elderly subjects: altruism; interpersonal contact; free care motivators like documentation, second opinions, and reassurance about their condition; also hope; novel experiences; and scientific involvement. Knowing what motivates subjects to participate is helpful in determining recruitment strategies. Murphy (1993) identified six broad motivational strategies: personalization, provision of explanatory information, offer of study results, acknowledgement of the right to decline participation, anonymity or confidentiality, and sponsorship (which promotes trust in the research team). The interaction between how these strategies fit with the motivators is shown in Table 1. Incentives other than free care may increase r e -

cruitment (Ashery & McAuliffe, 1992; Diekmann & Smith, 1989). One incentive to keep the control group in the study is to offer delayed treatment to the control group (Ashery & McAuliffe, 1992). Sometimes gifts to subjects are useful (Murphy, 1993). Gifts can take many forms, for example a bibliography on the research topic to registered nurses was proposed by Crosby, Ventura, Finnick, Lohr, and Feldman (1991). Personalized recruitment materials may increase the motivation for those who would participate due to altruism and those motivated by trust in the research team. A hand-written note between phases of participation increased second phase response by 41% and personalized mailout packages increased third round responses by 53% (Maheux, Legault, & Lambert, 1989). Face-to-face recruitment usually works better than letters or phone calls (Diekmann & Smith, 1989; Wewers & Ahijevych, 1990). Approaching potential subjects as individuals or small groups depends on topic and population characteristics. Crosby et al. (1991) found that nurse aides who were to be followed and observed in their work responded better to recruitment efforts when approached initially in small groups. Positive feedback from the first few subjects is very helpful (Ashery & McAuliffe, 1992). Many techniques contribute to building trust in the research team. A positive, comfortable, safe environment for pitching the study is important (Crosby et al., 1991). Acknowledgement of subject rights builds confidence in the research team. Endorsement and support of other health care professionals can be the key to establishing research team credibility with potential subjects (Diekmann & Smith, 1989). Building of trust between researcher and subjects is important to recruitment,

Table 1. Motivation for Research Participation Types of Motivators Free care

Strategies

Altruism

Incentives Personalization Positive environment Explanation Acknowledge rights Sponsorship & endorsement Appearance

X X X X X X

Note: X indicates a strategy is an important motivator.

or services X X X X X X

Trust in research team

X X X X X X

Importance of research

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but it must be built using the highest ethical standards of truth in communication. Another motivation situation is response rate to mailed surveys. This type of recruitment has some well-documented methods to maximize response rates (Crosby et al., 1991; Dillman, 1978; Murphy, 1993). Much has been written concerning mail surveys and how to increase the response rate, therefore, only a few points will be made here as sometimes surveys are handed out along with other methods of data collection. Appearance (professional) and readability (both print size and language) are key elements to even the personally handed survey. Laurakas (1987) gave similar advise when doing telephone surveys. Time Frame Barriers

The time frame barriers to the research design are very important. In recruitment, the availability of subjects within the specified time frame seems obvious, but may only be obvious in retrospect if not purposively evaluated early. If a researcher targets only patients with myocardial infarction who are admitted directly to the coronary intensive care unit, it is important to discuss that in the selected site all of these patients are admitted through the emergency room. If the researcher anticipates interviewing postpartum mothers 48 to 72 hours after birth, it is critical to discuss the potential site's usual pattern for postpartum hospital stays. Similarly, a data collection plan for a representative staff nurse sample that encompasses only a Mon-

day through Friday schedule can have severe limitations from a staff that has a large weekend-only contingent. Somewhat different is the timing of seeking agency access resulting in denial of access to subjects by agency or other professionals for a variety of reasons: too many researchers per subjects, disinterest on part of gatekeeper(s), or perception of agency effort exceeding expected value (Cronenwett, 1986). Preliminary discussions at the proposed site may clarify the site's availability. CONCLUSION

Recruitment for research is a many-faceted task. The research team must identify and address the barriers inherent in the research protocol, population characteristics and motivators, and site characteristics (Young & Dombrowski, 1989). Recruitment plans need careful attention or faulty recruitment can compromise design and methods plans. A careful balance of marketing techniques and ethical considerations are necessary if nurses are to be as respectful of research subjects as they are of clients. After recruitment, retention then becomes the issue and many of the same factors must be considered in retention efforts (Holm & Penckofer, 1990). The effort is necessary, for most studies are unsound if the subject characteristics are based on faulty recruitment. The wise nurse researcher attends to recruitment very conscientiously.

REFERENCES Ashery, R., & McAuliffe, W. (1992). Implementation issues and techniques in randomized trials of outpatient psychosocial treatments of drug abusers: Recruitment of subjects. American Journal of Drug and Alcohol Abuse, 18, 305-329. Carico, J., & Harrison, E. (1990). Ethical considerations for nurses in biomedical research. Journal of Neuroscience Nursing, 22, 160-163. Clark, R. (1993). Consent, assent, and children in research. Drug Information Journal, 27, 1241-1246. Cronenwett, L. (1986). Access to research subjects. Journal of Nursing Administration, 16(2), 8-9. Crosby, F., Ventura, M., Finnick, M., Lohr, G., & Feldman, M. (1991). Enhancing subject recruitment for nursing research, Clinical Nurse Specialist, 5, 25-30. Davis, A. (1989). Informed consent process in research protocols: Dilemmas for clinical nurses. Western Journal of Nursing Research, 11, 448-457. Diekmann, J., & Smith, J. (1989). Strategies for accessment and recruitment of subjects for nursing research. Western Journal of Nursing Research, 11, 418-430.

Dillman, D. (1978). Mail and telephone surveys: The total design method. New York: Wiley. Dilonardo, J., Kendrick, K., & Vivaldi, K. (1993). Chronic or long-term psychiatric patients: Potential subjects for longitudinal research. Issues in Mental Health Nursing, 14, 109118. Everson-Bates, S. (1988). Research involving children: Ethical concerns and dilemmas. Journal of Pediatric Health Care, 2, 234-239. Holm, K., & Penckofer, S. (1990). Editorial commentary: Difficulties associated with subject recruitment and retention. Cardiovascular Nursing, 26(4), 24. Johansen, M., Mayer, D., & Hoover, H. (1991). Obstacles to implementing cancer clinical trials. Seminars in Oncology Nursing, 7, 260-267. Laurakas, P. (1987). Telephone survey methods: Sampling, selection, and supervision. Newbury Park: Sage. Maheux, B., Legault, C., & Lambert, J. (1989). Increasing response rates in physicians' mail surveys: An experimental study. American Journal of Public Health, 79, 638-639.

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McNeely, E., & Clements, S. (1994). Recruitment and retention of the older adult into research studies. Journal of Neuroscience Nursing, 26, 57-61. Murphy, C. (1993). Increasing the response rates of reluctant professionals to mail surveys. Applied Nursing Research, 6, 137-141. Newberg, S., Holland, A., & Pearce, L. (1992). Motivation of subjects to participate in a research trial. Applied Nursing Research, 5, 89-104. Patemostro, J. (1991). Working in psychiatric research: Answers tomorrow, dilemmas today. Perspectives in Psychiatric Care, 27(3), 33-36. Raudonis, B. (1992). Ethical considerations in qualitative research with hospice patients. Qualitative Health Research, 2, 238-249. Rempusheski, V. (1991). Elements, perceptions, and issues of informed consent. Applied Nursing Research, 4, 201-204. Schulberg, H., Coulehan, J., Block, M., Lave, J., Rodriguez, E., Scott, C., Madonia, M., Imber, S., & Perel, J.

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(1993). Clinical trials of primary care treatments for major depression: Issues in design, recruitment, and treatment. International Journal of Psychiatry in Medicine, 23, 29-42. Souder, J. (1992). The consumer approach to recruitment of eider subjects. Nursing Research, 41, 314-316. Sung, J., Coates, R., Williams, J., Liff, J., Greenberg, R., McGrady, G., Avery, B., & Blumenthal, D. (1992). Cancer screening intervention among Black women in inner-city Atlanta-design of a study. Public Health Reports, 107, 381388. Wewers, M., & Ahijevych, K. (1990). Differences in volunteer and randomly acquired samples. Applied Nursing Research, 3, 166-173. Williams, S. (1993). How do the elderly and their families feel about research participation? Geriatric Nursing, 14, 1114. Young, C., & Dombrowski, M. (1989). Psychosocial influences on research subject recruitment, enrollment and retention. Social Work in Health Care, 14(2), 43-57.