Evidence-based practice must be based on the evidence. This seems like a redundant and simple statement, but for many of the interventions used for obstetrical care, there is limited evidence. We cannot practice optimally without an evidence base. Without an evidence base, practitioners do not know if their interventions are beneficial, neutral, or actually cause harm to the patient and, in maternal-child care, to either or both patients. Women have traditionally been excluded from research protocols chiefly because of the potential for pregnancy. Women have been included in phase 3 research trials only since 1993.1
The Women's Health Initiative was one of the first and largest studies to focus on women. The success of the Women's Health Initiative has led researchers to include women in trials and research and to consider trials that are specifically for women. In 1990, the National Institutes of Health created the Office of Research on Women's Health to serve as a pivotal clearinghouse for National Institutes of Health-funded research focusing on women's health.
Staff nurses on the inpatient labor and delivery unit may feel too busy to participate or design research protocols. However, without the participation and input from staff nurses, studies will not be successful or relevant. Nurses may play 2 roles on the inpatient labor and delivery unit: primary or secondary researcher or patient advocate. These roles may be congruent or opposite.
Nurses who provide direct care at the bedside may feel that research protocols interfere with the patient-nurse relationship. Nurses may also feel that research protocols add to the already busy work on the unit and can be a burden that offers little or no benefit to the patient or to the unit. Direct patient care may have a different purpose than the goal of the research study. Connelly2 points out that potential conflicts must be considered and that real conflicts can occur when caring for a patient who is also enrolled in a research protocol. As an example, a double-blinded medication study could interfere with the ongoing care of the patient.2
Reynolds et al3 studied clinical staff nurses' perceptions of research in the neonatal intensive care environment (NICU). The authors surveyed 250 neonatal nurses working in a 70-bed level III NICU in the United States. The setting was in an academic hospital and was very research-oriented, with typically 10 or more clinical studies being conducted in the NICU at any given time. Thirty-three percent of the nurses completed the survey; 44% of these nurses had more than 20 years of experience in the NICU. The nurses overwhelming felt that incorporating new research in the NICU environment is necessary for improving care, but only slightly more than half of the nurses felt that the ongoing research impacted their day in a positive manner. The majority of nurses also felt that ongoing research complicated the work environment. Poor communication between the research team and the clinical staff was seen as a barrier to participation in research.3
Burnett et al4 developed a system of staff nurse champions when instituting a research team to assess a Fall Risk Assessment Tool. Each unit participating in the study had a staff nurse champion who was responsible for staff education, enrolling patients as subjects, facilitating data collection, and promoting staff engagement with the study design and methods.4 The implementation of the tool was enhanced by the participation of the champions. There was efficient enrollment of study participants because the champions understood the work flows of their units and knew the characteristics of their specific patient populations. Embedding the champion in the unit also allowed for conversations and critical thinking by staff nurses regarding fall prevention and strategies to improve patient outcomes. The major challenge to the utilization of the champions was time. Each champion needed nonpatient care time built into the schedule. Other time challenges included shift rotations and differing role responsibilities. Each champion took several months to settle into an efficient and workable routine, a time not anticipated by the study designers. Unit leader support was critical.
When the researcher is also the bedside nurse, other challenges may present themselves. When conducting interviews with vulnerable populations, such as laboring women, the line between researcher and nurse can sometimes be indistinct.5 Many subjects in labor and delivery can be emotional or distressful to patients. Researchers must at times create an "empathic distance,"5 avoiding the role of nurse and counselor and sometimes reduce the rapport the nurse may naturally feel with the patient and her family, especially with difficult situations such as prematurity, fetal demise, or abusive situations.
As patient advocate for laboring women and their families, staff nurses may find themselves in conflict with researchers. The welfare of the patient should always be the primary consideration for the nurse. If the study is an ongoing project on the unit, the primary investigator has the responsibility to educate the staff on the methods, design, and potential complications that may arise from study participation. This responsibility includes informing the staff of avenues for reporting conflicts that may arise between protection of the patient and requirements of the study protocol.2 All study protocols need evaluation by an institutional review board, even informal surveys. If the study protocol is not familiar to the staff nurse, the unit manager has the responsibility to contact the primary researcher and determine if it is possible to support the patient's further participation in the study while she is on the unit.2 The nature of the labor and delivery unit with acute care admissions and short stays may not be congruent with some investigational research protocols.
The staff nurse as patient advocate should not assume that because the study has been approved the protocol is ethical or appropriate for the population on his or her unit. There may be divergence between the protocol as approved and the protocol as it is administered. If the nurse has reservations about the protocol or feels uncomfortable with the informed consent or lack of informed consent, he or she has the ethical responsibility to report these concerns to the unit manager as soon as he or she realizes the problem.
Labor and delivery units may have the added complication of a large number of adolescent patients, depending on the unit. An adolescent's ability to give consent is governed by state law. Similar to adult patients, the staff nurse should feel comfortable with the teenager's ability to understand and make decisions that affect her care and the care of her infant.
The significance and consequence of real-world translational research cannot be underestimated, although this research is often undervalued.6 Nursing research on labor and delivery to validate the nursing contribution to the lived experience of giving birth makes a valuable contribution to the knowledge base and to the care we give to laboring women and their families. There are few other units that use such intense nursing interventions and hands-on acute care in a short time span as does the labor and delivery unit. Women's birth stories almost always credit or discredit their nursing care. The nurse acts as a conduit of information to the midwife or physician while providing updates to the family and high touch care to the laboring woman.
Nurses' contributions to the research base enable the translation of basic research or current clinical findings to the birthing setting. Nurses also act to safeguard the patient when she needs this protection. It is essential that we have nursing involvement in both the research protocols and in the maintenance of the integrity of the patient experience. Support by unit leadership is critical to the involvement of bedside nurses in research, or time constraints will impact the participation and enthusiasm for clinical trials by nursing staff. We intuitively think that our nursing interventions make a difference, but only by study and dissemination can we prove the worth of what we do.
-Jackie Tillett, ND, CNM, FACNM
Clinical Professor
Department of Obstetrics and Gynecology
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin
References