- Email: [email protected]
Recruiting Neonatal and Infant Patients for Research, Part 2
Newborn & Infant Nursing Reviews 16 (2016) 129–130
Contents lists available at ScienceDirect
Newborn & Infant Nursing Reviews journal homepage: www.nainr.com
Research Methodology Column
Recruiting Neonatal and Infant Patients for Research, Part 2☆ Jana L. Pressler, PhD, RN ⁎ College of Nursing Lincoln Division, University of Nebraska Medical Center, UNMC College of Nursing, 1230 O Street, Ste 131, Lincoln, NE 68508, USA
a r t i c l e
i n f o
Keywords: Recruitment Marketing Neonatal Vulnerable patients
a b s t r a c t This Research Methodology Column will address issues and topics pertinent to conducting neonatal and infant research. Some of the columns will address current issues and topics while others will address longstanding or classic issues and topics. The goal of these columns is to inform novice and expert nurse researchers about the research process with neonates and infants, and help troubleshoot issues that might prevent, impede, or suspend research. This second column is devoted to the first considerations of recruitment of neonate/infant research participants. © 2016 Elsevier Inc. All rights reserved.
Recruiting neonatal and infant participants for research studies can become a significant challenge that was not originally anticipated. To recruit neonates and infants into any research protocol requires formal permission from a legal guardian, typically one or both parents. This article discusses aspects of the recruitment process and important factors to consider pertinent to retention. The Process of Recruitment Initial steps that a researcher must take in planning to recruit research study participants involve developing a clear definition of the population of interest and identifying where access to that population is available and achievable. Once the potential sites for recruitment are established, described, and evaluated for access, plans can be prepared for reaching out to the parents and/or legal guardians in the recruitment sites who can give written consent for neonates/infants' participation. When developing the study design, it is important to acknowledge that if the purpose of the research study comes across as being too involved for the infant, the neonate/infant's parents might refuse to allow their infant to be included. Thus, critically reviewing the stated purpose of the study and making sure that it does not appear overly ambitious is well worth the time. Recruiting the Most Vulnerable Research Participants When a researcher wishes to study a vulnerable neonate/infant population, s/he must consider several important factors. These include: the likelihood of infant mortality, the extent of comorbid conditions that the neonate/infant might have, the stability of the neonate/infant's physiologic status, and whether or not the potential infant participant is already enrolled in any other research protocol that, for whatever reason, would ☆ The author declares no conflict of interest. ⁎ Tel.: +1 402 472 3683. E-mail address: [email protected]. http://dx.doi.org/10.1053/j.nainr.2016.08.010 1527-3369/© 2016 Elsevier Inc. All rights reserved.
make her/him ineligible to participate in another research study.1 Of these factors, the most challenging participants to obtain will be those who have the highest probability of not surviving. Thus, when critically ill neonate/infant research participants are desired for a research project, a researcher might be wise to have more than one source for recruiting participants. Note that in cases when ill neonates/infants are desired as participants, there can be a high rate of refusal or rejection by their primary health caregivers in addition to the parent(s) as well. When survival of potential infant participants is significantly less likely, the researcher also might have to explore ways to conduct a study using extremely small sample sizes and/or highly sophisticated analytic techniques for maximizing the data that are collected. For example, when data are missing from certain variables on a project involving a small sample, a researcher might choose to impute values for data that are missing to better approximate events not able to be measured directly. Documenting that a neonate/infant is physiologically stable enough to join in anything extra can involve assuring that the potential participant has not required resuscitation within the past 24 hours. Waiting over 24 hours might mean excluding recruiting all new admissions to the NICU until after the first postnatal day cared for in the unit. Further, neonates/infants are regarded as a highly vulnerable population. As such, those potential vulnerable participants might be prohibited from participating in any more than one study at any one time. It is important to be fully cognizant of the rules followed by the institution to protect vulnerable populations. Recruiting Control or Comparison Neonate/Infant Participants Researchers might initially think and discover that recruiting and studying the desired sample of neonates/infants is the most challenging. Yet sometimes obtaining a control group or comparison participants can be challenging too. Securing participants who are similar on all but one or two variables can involve complicated screens and decisions. For example, if a researcher is trying to compare neonates/infants of a certain gestational age, it might be difficult to find extremely young gestation neonates (e.g., 24–26 weeks) who were never on a ventilator as controls for
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J.L. Pressler / Newborn & Infant Nursing Reviews 16 (2016) 129–130
participants of interest, who were studied while on a ventilator. It also can be a challenge finding extremely preterm neonates who never experienced any apnea or bradycardia episodes to compare with those who did experience such episodes. In those situations, the researcher might have to find times when there were no episodes in the same participants and use the neonates/infants as their own controls. When questions arise about control or comparison participants, the best recommendation is to consult with a statistician or research methodologist to develop a workable solution. Recruiting from Specific Types of Caregiving Settings Various neonatal/infant caregiving settings will have their own rules for recruiting neonate/infant participants. It is logical that environments where infants are the most critically ill, receiving the most intensive care, and having the most complicated treatments will have guidelines restricting researchers from disturbing infants except during specific windows of time. Mothers with well newborns can also restrict access to their babies in order to facilitate their own close maternal bonding and breastfeeding. Sometimes hospital recruiting requires that a researcher be on “standby” for when the parent(s) are physically present and can be contacted by the researcher to explain the study procedures. Recruiting neonates or infants in home settings can be highly dependent on mothers' preferences for receiving visitors and whether she agrees to a researcher disturbing her privacy by visiting her infant. Parents offer consent for their neonates/infants as minors to participate in research and have to feel fully informed and in agreement before they will give formal written permission. Telephone calls to parents ahead of in-person meetings can help prepare parent(s) for questions they might want to ask when meeting a participant recruiter. At times the setting can add to the challenge of recruitment; other times it might not make any difference about the degree of difficulty involved. As noted in Part 1 (found in the June, 2016 issue) of recruiting research participants, sometimes it is difficult to identify and recruit neonate/infants research participants because of specific background variables or desired neonate/infant demographics. Typically screening potential participants for inclusion and exclusion criteria ends up being a major sorting process for the recruiter. Neonatal/Infant Participant Retention It can be challenging retaining neonatal/infant study participants in research projects that involve a series or sequence of measurements of
specific variables. Having more than one measurement of any variable can strengthen its reliability and validity. Yet maintaining neonates/infants' enrollment in research projects requires that the participants continue to meet study inclusion criteria and that their parent(s) continue to allow them to participate in the study. If the neonate/infant's physiologic status is highly variable, there is a high likelihood that participants will have to drop out of the study due to no longer meeting one or more of the study inclusion criteria.2 In addition, the more variable the neonate/infant's physiologic status, the more likely that their parent(s) will not want any additional stimuli added to their infant's list of activities. Parents try their best to protect their neonate/infant from undue stress, particularly when their infants are deemed more vulnerable. Sometimes neonatal/infant research participants drop out of a study due to transfer to another unit or another hospital, or are unexpectedly discharged from the hospital entirely. A researcher can never be certain that a neonate/infant research participant will be able to complete all of their study procedures until the final measurements have been obtained. Because of the uncertainty involved in retaining neonates/infants in research projects, it is wise to plan to over-sample from the onset to allow for the possibility of attrition, both anticipated and unexpected. Summary There are definite challenges to recruitment of neonate/infant research study participants, some common and some specific to the setting. Recruiting and retaining neonate/infant research participants requires careful planning. Even the best laid plans can fail when the participants having the characteristics and background required are unavailable or inaccessible. The optimal recommendation for researchers desiring to study neonates/infants in various settings is to find out how easy it has been for researchers engaging in similar types of research to obtain and retain their samples. Such findings can then be used to guide others in their research pursuits. References 1. UyBico SJ, Pavel S, Gross CP. Recruiting vulnerable populations into research: a systematic review of recruitment interventions. J Gen Intern Med. 2007;22:852-63, http://dx.doi.org/10.1007/s11606-007-0126-3. 2. Kavanaugh K, Moro TT, Savage T, Mehendale R. Enacting a theory of caring to recruit and retain vulnerable participants for sensitive research. Res Nurs Health. 2006;29: 244-52, http://dx.doi.org/10.1002/nur.20134.
Contents lists available at ScienceDirect
Newborn & Infant Nursing Reviews journal homepage: www.nainr.com
Research Methodology Column
Recruiting Neonatal and Infant Patients for Research, Part 2☆ Jana L. Pressler, PhD, RN ⁎ College of Nursing Lincoln Division, University of Nebraska Medical Center, UNMC College of Nursing, 1230 O Street, Ste 131, Lincoln, NE 68508, USA
a r t i c l e
i n f o
Keywords: Recruitment Marketing Neonatal Vulnerable patients
a b s t r a c t This Research Methodology Column will address issues and topics pertinent to conducting neonatal and infant research. Some of the columns will address current issues and topics while others will address longstanding or classic issues and topics. The goal of these columns is to inform novice and expert nurse researchers about the research process with neonates and infants, and help troubleshoot issues that might prevent, impede, or suspend research. This second column is devoted to the first considerations of recruitment of neonate/infant research participants. © 2016 Elsevier Inc. All rights reserved.
Recruiting neonatal and infant participants for research studies can become a significant challenge that was not originally anticipated. To recruit neonates and infants into any research protocol requires formal permission from a legal guardian, typically one or both parents. This article discusses aspects of the recruitment process and important factors to consider pertinent to retention. The Process of Recruitment Initial steps that a researcher must take in planning to recruit research study participants involve developing a clear definition of the population of interest and identifying where access to that population is available and achievable. Once the potential sites for recruitment are established, described, and evaluated for access, plans can be prepared for reaching out to the parents and/or legal guardians in the recruitment sites who can give written consent for neonates/infants' participation. When developing the study design, it is important to acknowledge that if the purpose of the research study comes across as being too involved for the infant, the neonate/infant's parents might refuse to allow their infant to be included. Thus, critically reviewing the stated purpose of the study and making sure that it does not appear overly ambitious is well worth the time. Recruiting the Most Vulnerable Research Participants When a researcher wishes to study a vulnerable neonate/infant population, s/he must consider several important factors. These include: the likelihood of infant mortality, the extent of comorbid conditions that the neonate/infant might have, the stability of the neonate/infant's physiologic status, and whether or not the potential infant participant is already enrolled in any other research protocol that, for whatever reason, would ☆ The author declares no conflict of interest. ⁎ Tel.: +1 402 472 3683. E-mail address: [email protected]. http://dx.doi.org/10.1053/j.nainr.2016.08.010 1527-3369/© 2016 Elsevier Inc. All rights reserved.
make her/him ineligible to participate in another research study.1 Of these factors, the most challenging participants to obtain will be those who have the highest probability of not surviving. Thus, when critically ill neonate/infant research participants are desired for a research project, a researcher might be wise to have more than one source for recruiting participants. Note that in cases when ill neonates/infants are desired as participants, there can be a high rate of refusal or rejection by their primary health caregivers in addition to the parent(s) as well. When survival of potential infant participants is significantly less likely, the researcher also might have to explore ways to conduct a study using extremely small sample sizes and/or highly sophisticated analytic techniques for maximizing the data that are collected. For example, when data are missing from certain variables on a project involving a small sample, a researcher might choose to impute values for data that are missing to better approximate events not able to be measured directly. Documenting that a neonate/infant is physiologically stable enough to join in anything extra can involve assuring that the potential participant has not required resuscitation within the past 24 hours. Waiting over 24 hours might mean excluding recruiting all new admissions to the NICU until after the first postnatal day cared for in the unit. Further, neonates/infants are regarded as a highly vulnerable population. As such, those potential vulnerable participants might be prohibited from participating in any more than one study at any one time. It is important to be fully cognizant of the rules followed by the institution to protect vulnerable populations. Recruiting Control or Comparison Neonate/Infant Participants Researchers might initially think and discover that recruiting and studying the desired sample of neonates/infants is the most challenging. Yet sometimes obtaining a control group or comparison participants can be challenging too. Securing participants who are similar on all but one or two variables can involve complicated screens and decisions. For example, if a researcher is trying to compare neonates/infants of a certain gestational age, it might be difficult to find extremely young gestation neonates (e.g., 24–26 weeks) who were never on a ventilator as controls for
130
J.L. Pressler / Newborn & Infant Nursing Reviews 16 (2016) 129–130
participants of interest, who were studied while on a ventilator. It also can be a challenge finding extremely preterm neonates who never experienced any apnea or bradycardia episodes to compare with those who did experience such episodes. In those situations, the researcher might have to find times when there were no episodes in the same participants and use the neonates/infants as their own controls. When questions arise about control or comparison participants, the best recommendation is to consult with a statistician or research methodologist to develop a workable solution. Recruiting from Specific Types of Caregiving Settings Various neonatal/infant caregiving settings will have their own rules for recruiting neonate/infant participants. It is logical that environments where infants are the most critically ill, receiving the most intensive care, and having the most complicated treatments will have guidelines restricting researchers from disturbing infants except during specific windows of time. Mothers with well newborns can also restrict access to their babies in order to facilitate their own close maternal bonding and breastfeeding. Sometimes hospital recruiting requires that a researcher be on “standby” for when the parent(s) are physically present and can be contacted by the researcher to explain the study procedures. Recruiting neonates or infants in home settings can be highly dependent on mothers' preferences for receiving visitors and whether she agrees to a researcher disturbing her privacy by visiting her infant. Parents offer consent for their neonates/infants as minors to participate in research and have to feel fully informed and in agreement before they will give formal written permission. Telephone calls to parents ahead of in-person meetings can help prepare parent(s) for questions they might want to ask when meeting a participant recruiter. At times the setting can add to the challenge of recruitment; other times it might not make any difference about the degree of difficulty involved. As noted in Part 1 (found in the June, 2016 issue) of recruiting research participants, sometimes it is difficult to identify and recruit neonate/infants research participants because of specific background variables or desired neonate/infant demographics. Typically screening potential participants for inclusion and exclusion criteria ends up being a major sorting process for the recruiter. Neonatal/Infant Participant Retention It can be challenging retaining neonatal/infant study participants in research projects that involve a series or sequence of measurements of
specific variables. Having more than one measurement of any variable can strengthen its reliability and validity. Yet maintaining neonates/infants' enrollment in research projects requires that the participants continue to meet study inclusion criteria and that their parent(s) continue to allow them to participate in the study. If the neonate/infant's physiologic status is highly variable, there is a high likelihood that participants will have to drop out of the study due to no longer meeting one or more of the study inclusion criteria.2 In addition, the more variable the neonate/infant's physiologic status, the more likely that their parent(s) will not want any additional stimuli added to their infant's list of activities. Parents try their best to protect their neonate/infant from undue stress, particularly when their infants are deemed more vulnerable. Sometimes neonatal/infant research participants drop out of a study due to transfer to another unit or another hospital, or are unexpectedly discharged from the hospital entirely. A researcher can never be certain that a neonate/infant research participant will be able to complete all of their study procedures until the final measurements have been obtained. Because of the uncertainty involved in retaining neonates/infants in research projects, it is wise to plan to over-sample from the onset to allow for the possibility of attrition, both anticipated and unexpected. Summary There are definite challenges to recruitment of neonate/infant research study participants, some common and some specific to the setting. Recruiting and retaining neonate/infant research participants requires careful planning. Even the best laid plans can fail when the participants having the characteristics and background required are unavailable or inaccessible. The optimal recommendation for researchers desiring to study neonates/infants in various settings is to find out how easy it has been for researchers engaging in similar types of research to obtain and retain their samples. Such findings can then be used to guide others in their research pursuits. References 1. UyBico SJ, Pavel S, Gross CP. Recruiting vulnerable populations into research: a systematic review of recruitment interventions. J Gen Intern Med. 2007;22:852-63, http://dx.doi.org/10.1007/s11606-007-0126-3. 2. Kavanaugh K, Moro TT, Savage T, Mehendale R. Enacting a theory of caring to recruit and retain vulnerable participants for sensitive research. Res Nurs Health. 2006;29: 244-52, http://dx.doi.org/10.1002/nur.20134.