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Oxytocin Guidelines Associated with Compliance to National Standards

Jackson, Jodi K., MD; Wickstrom, Elizabeth, MD; Anderson, Betsi, RN, CPHQ

MCN: The American Journal of Maternal/Child Nursing: May/June 2019 - Volume 44 - Issue 3 - p 128–136
doi: 10.1097/NMC.0000000000000520
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Objective: Develop a multidisciplinary, consensus-driven, evidence-based approach to oxytocin use, while adhering to national guidelines.

Design: This was a quality improvement project that used the Plan Do Study Act method to create cycles of change over several years. To initiate discussion, a survey was administered at a social event for providers from divergent community practices that addressed the controversial aspects of oxytocin use. Graphic feedback was provided showing divergences between answers and the evidence. The perinatal team directed design and implementation of this project with specific involvement of a nurse quality improvement coordinator and nurse educator.

Measures: Process, outcome, and balancing measures were used to evaluate the program. Process measure: use of a standardized order-set. Outcome measure: rate of adherence to the resultant protocol. Balancing measures: 1) maximum oxytocin dose, 2) time from oxytocin initiation to birth, 3) cesarean birth rates, and 4) Apgar scores.

Results: An initial increase in adherence to the protocol decreased with the loss of the “paper” order-set. Adherence improved when computerized physician order entry was adjusted: 2006: 73%, 2007: 95%; 2011: 57%, 2013: 100% (p = 0.007, 2006 vs. 2007) (p < 0.001, 2006 vs. 2013). Compliance with the protocol was associated with a decrease in maximum oxytocin dose and in time between oxytocin initiation and birth (p < 0.001).

Conclusion: Consistency and safety in patient care can be accomplished using literature-based evidence and active consensus building among members of the perinatal team. A standardization process must be integrated into the electronic medical record to become a sustained part of a practice culture.

In this quality improvement project, a multidisciplinary team developed an evidence-based approach for use of oxytocin for induction and augmentation of labor based on a review of the literature, consensus building, and teamwork. Compliance with the standardized protocol was associated with a decrease in the maximum oxytocin dose and in the time between oxytocin initiation and birth. Fears of increasing the rate of cesarean birth due to a less aggressive method of using oxytocin were not found to be supported.

Jodi K. Jackson is a Neonatologist, Children's Mercy-Kansas City, University of Missouri-Kansas City School of Medicine, Department of Pediatrics, Kansas City, MO. The author can be reached via e-mail at jjackson@cmh.edu

Elizabeth Wickstrom is a Maternal-Fetal Medicine Specialist, Obstetrix Medical Group of Kansas and Missouri, Shawnee Mission Medical Center, Merriam, KS.

Betsi Anderson is an Administrative Director, Children's Mercy-Kansas City, Kansas City, MO.

The authors declare no conflicts of interest.

Figure

Figure

Using oxytocin for labor induction increases risks for adverse outcomes, including operative birth, abnormal fetal heart rate tracings, and uterine tachysystole (Bakker, Kurver, Kuik, & Van Geijn, 2007; Jonsson, Cnattingius, & Wikström, 2013; Nabi, Aflaifel, & Weeks, 2014; Sundin, Mazac, Ellis, & Garbo, 2018). Historically, as oxytocin use has increased, wide variations in dosing have augmented these risks (Clark et al., 2007; Rozich et al., 2004). An additional stimulus leading to a need for more standardized use of this high-alert medication has been the potential for malpractice litigation. At least half of all paid obstetric malpractice claims involve allegations of oxytocin misuse (Clark, Belfort, Byrum, Meyers, & Perlin, 2008; Clark, Belfort, Dildy, & Meyers, 2008; Hayes & Weinstein, 2008; Simpson & Knox, 2009). Among these claims are cases of oxytocin being used at too high a dose or given under high-risk situations, resulting in uterine tachysystole and abnormal fetal heart rate tracings (Macones, Hankins, Spong, Hauth, & Moore, 2008). Moreover, changing definitions of tachysystole have complicated the issue, making it difficult for providers to keep pace with national recommendations (American College of Obstetricians and Gynecologists [ACOG], 2005; 2009a and 2009b). High-profile lawsuits and ongoing educational efforts of several hospital systems have focused on the problem of uterine tachysystole related to oxytocin use as a national issue (Clark, Belfort, Byrum, et al.; Pettker et al., 2009; 2014; Simpson, Kortz, & Knox, 2009).

When quality improvement (QI) teams attempt to address oxytocin use and its attendant risks, it becomes apparent that differences in practice among, and within, obstetric provider groups are wide, and efforts to standardize use can encounter emotional resistance. Inconsistencies in communication between providers and nurses at critical junctures of patient care contribute to this barrier to practice standardization (Clark, Simpson, Knox, & Garite, 2009; Clayworth, 2000; Simpson, James, & Knox, 2006; Simpson & Lyndon, 2009; 2017). The administrative directors of a high-volume, community-based obstetrical unit determined to address this issue through the formation of a Perinatal Safety Committee. Here we detail the development, implementation, and impact of this community hospital's protocol for use of oxytocin during labor and birth.

The association between a standardized approach to oxytocin use and a decrease in the untoward outcomes often associated with excessive exposure to oxytocin is well documented (Clark et al., 2007; Clark, Belfort, Byrum, et al., 2008; Clark, Belfort, Dildy, et al., 2008; Clark et al., 2009; Hayes & Weinstein, 2008; Rhinehart-Ventura, Eppes, Sangi-Haghpeykar, & Davidson, 2014; Simpson & Knox, 2009). The goal of this QI project was not to contribute to that body of evidence but to report the process of facilitating collaboration to build a consensus-driven, evidence-based approach to the use of oxytocin, adhering to national guidelines, among competing private practice groups in a community-based hospital.

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Methods

Setting

The institution is a large, private, faith-based community hospital. Data were analyzed from 2006 to 2013. The Birth Center expanded in February 2013 from 17 to 26 beds with the construction of a freestanding birth center. The facility has grown from 50 labor and delivery nurses in 2006 to 88 in 2013. The number of births steadily increased from 3,620 in 2006 to 4,474 in 2013. This hospital has consistently had approximately 60 birth providers, mostly obstetricians, with 5% family medicine physicians and certified nurse midwives (CNMs).

The timeframe of this project spans significant changes in the physical environment in which care has been given, as well as in the literature regarding oxytocin use. At the start of this project, very few definitive statements existed regarding the many definitions used to describe oxytocin use and its effects. In December of 2005, 2009a and 2009b specific statements were made by ACOG about these definitions. Despite these definitive statements, it is well described in the literature that it generally takes 13 to 18 years for evidence to become standard of care (Institute of Medicine, 2001; Morris, Wooding, & Grant, 2011). These gaps between credible evidence and local practice are related to knowledge, shared understanding, and standardized systems, and are known to contribute to patient safety issues (Institute of Medicine; Morris et al.). When this work has been presented regionally, it has been noted that many birth centers still do not clearly define or standardize use of oxytocin and these centers have found the tools described within helpful.

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Human Subjects Protection/IRB Statement

This is not a human subjects study, but rather a project designed to improve quality of care using evidence-based medicine. The hospital has a process by which projects of this type are reviewed by a QI arm of the Institutional Review Board (IRB); this program qualified under that process as a QI initiative.

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Intervention

In February of 2006, a multidisciplinary task force was formed to evaluate the literature, meet with experts in the field, and evaluate standardized processes used at other facilities (benchmarks). The task force included nurses, nursing and medical administrators, obstetricians, pediatricians, maternal–fetal medicine specialists, neonatologists, librarians, educators, lactation experts, and pharmacists. The CNMs on staff at the hospital who were members of the Perinatal Safety Committee and their colleagues were invited to participate in the task force but chose to contribute as project participants. A standardized QI method, Plan Do Study Act (PDSA), was used to create cycles of change (Taylor et al., 2014). The Edwards Deming PDSA change model was selected based on the experience of the nurse QI coordinator and physician QI leader (Edwards Deming Institute, n.d.). A gap analysis was performed comparing literature-based recommendations to general practice within the unit evaluated. General similarities in practice were identified, as well as barriers to consistent adherence to standardized recommendations.

The nursing group led the literature review and development of an oxytocin protocol, which adhered to recommendations for that time. At the direction of the Perinatal Safety Committee, the protocol was put into place, and the bedside nurse had the duty of ensuring the providers practiced within the protocol. However, this was met by resistance from providers due to a lack of shared education, knowledge, and ownership between bedside nurses and providers.

After analyzing this resistance, an innovative approach to the Delphi Technique was used to engage providers from diverse community practices in this process of improvement (Green, Armstrong, & Graefe, 2007). The Delphi method is a structured communication technique, originally developed outside of the field of medicine as a systematic, interactive method to bring divergent expert opinions closer together. In the traditional use, experts answer questionnaires in two or more rounds. Generally during this process, the range of the answers decreases over days to weeks of surveys and the group will converge toward a consensus. This approach was modified in that feedback was to be given in real time with the opportunity for open discussion. In October 2006, a semiformal evening event was orchestrated, in which physicians and midwives gathered to review the literature and, through iterative discussions, build consensus on an oxytocin protocol.

The process for writing the oxytocin protocol was planned as follows: 1) Where the literature agreed with personal biases, the concepts would be incorporated into the protocol. 2) Where biases were not in line with the literature, more evidence would be sought and discussed until all participants agreed. 3) The protocol needed to be consensus-driven and evidence-based, and the care team needed to work together to make sure all agreed. Using this process, it was expected that a significant amount of time and several iterations of the protocol would be needed to establish consensus. However, the protocol was created during the one evening “Delphi” event, and incorporated all of the elements discussed.

For this project, 20 questions covering 7 topics were posed (Table 1) concerning elements of oxytocin use to be discussed by providers during the medical staff social and educational event. During the “social hour,” unstructured portion of the program, participants read the questions on posters around the room and were asked to record and turn in their answers. The questions did not necessarily reflect the opinions of the task force or the evidence in the most recent literature. The goal of posing these questions was to uncover conscious and unconscious biases of the providers through their responses. Some responses may have been correct according to literature of an earlier era. In these cases, it was important to point out the previous literature-based conclusions alongside the more current definitions and statements. For this reason, some older literature is included in the questions table (Table 1). During dinner, the questions were then displayed through a slide presentation, along with the distribution of answers from the “social hour” and the pertinent peer-reviewed medical literature surrounding each question. A 5-point Likert scale was used to respond to the survey questions, indicating a spectrum for agreement/disagreement (Figure 1). Using this process, answers were displayed in real time to illustrate divergences within the group, as well as whether opinions expressed correlated with clinical evidence (Figure 1). This project was initiated in 2006, before the ACOG (2009a; b) practice bulletins on Induction of Labor and Intrapartum Fetal Heart Rate Monitoring were published.

Table 1

Table 1

Figure 1

Figure 1

This modified Delphi Technique yielded consensus for standardizing the key elements of oxytocin use during the course of one evening event. Thereafter, a standardized order-set was constructed by the task force using data from this meeting. The standardized order-set included the components described in the outcome measures section of this report. To successfully implement use of the Delphi Technique in such a short time, a nurse QI coordinator and nurse educator were recruited to help design the evening event and assist with calculating and collating participant responses.

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Measures

Process Measures:

  • 1) Use of a standard order-set to facilitate adherence to the protocol.
  • 2) The form in which that order-set was communicated: paper versus computer.
  • 3) Process of education of birth providers (including nurses, CNMs, and physicians).

Outcome Measures:

Adherence to a consensus-driven, evidence-based standard approach to oxytocin use. The standard approach was defined by the parameters listed below:

  1. Initial infusion rate no more than 2 milliunits per minute (mU/min).
  2. Increases in oxytocin infusion rate less than or equal to 2 mU/min at interval of less than or equal to 20 minutes.
  3. Maximum oxytocin infusion rate less than or equal to 20 mU/min without a provider's order.
  4. Uterine contraction monitoring to assess for tachysystole.
  5. Variation from the protocol was allowed when there was clear documentation by the provider as to why this variation was necessary.

Balancing Measures:

  1. 1) Maximum oxytocin dose: a. Mean, b. Dosage range;
  2. 2) Time from initiation of oxytocin to birth (hours);
  3. 3) Cesarean birth rate;
  4. 4) Neonatal Apgar scores at 1 and 5 minutes.

All measures were compared prior to implementation of this standardized approach (June 2006), and within 4 months following implementation (February 2007). The measures were evaluated again in May 2009. New challenges were subsequently noted with the implementation of a computerized physician order entry (CPOE) system in 2010-11. Initially, with the transition from a standardized paper order-set to a computer-based, system-wide order-set, the ability to ensure a uniform practice that met the same specifications was lost (August 2011). Through education about this unintended variance and its consequences, the CPOE system was modified to further support the evidence-based, consensus-driven practice developed through this project (July 2013).

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Data Collection

Although the standardized approach was to be adopted for all situations when oxytocin is used, the target population for measurement was women scheduled for labor induction using oxytocin at more than 39 0/7 weeks gestation. This population was specifically chosen for measurement because it was deemed likely to have the lowest rate of compliance. Over the course of the project, beginning with the original oxytocin protocol recommended by the Perinatal Safety Committee, physicians expressed concerns that these patients may need a more aggressive approach to oxytocin use, and that prescribing oxytocin use in this specific manner would lead to longer labor induction times and higher cesarean birth rates. By focusing on this subset in particular, the true effect of the protocol on provider compliance with use of the order-set could be illustrated, while measuring the unintended consequences of these concerns and biases.

Cases were evaluated as follows: 1) in 2006, prior to a written order-set; 2) in 2007, following the advent of a written order-set, and an update of the standing protocol; 3) in 2009, after the written order-set had been in place for 2 years, with no ongoing formal education; 4) in 2011, after the initial introduction of the electronic order-set; and 5) in 2013, after the revision of the electronic order-set to reflect the previous evidence-based, consensus-driven order-set (Table 2).

Table 2

Table 2

Figure

Figure

Charts were reviewed by multidisciplinary team members initially as paper charts and later as electronic medical records (EMR). A standard data collection form was used to direct the information collected.

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Data Analysis

Descriptive statistics including means, standard deviations, and proportions were used to summarize data. Group comparisons of categorical variables were analyzed using chi-square tests. T-tests and ANOVA with Tukey's post hoc comparisons were used to compare groups on continuous variables. Data analysis included number of cases reviewed and inconsistent data recorded in 2009. As an ongoing QI project, using data as it could be collected was an expected limitation.

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Results

Process Measures

In the culture of this community hospital, there was no standardized way to order oxytocin in 2006; all providers wrote independent orders. From 2007 to 2009, a standardized paper order-set that required only a provider signature was available for ordering oxytocin. In 2010, a system-wide CPOE order-set (accommodating multiple hospitals) was built without the forcing functions of the previous local order-set (the 2011 data reflects this change). In 2013, a hospital-specific CPOE order-set was developed featuring standardized orders. Between the timing of the 2006 and 2007 data collections, a system-wide education effort took place that included 100 nurses and 35 birth providers directly involved in the consensus protocol and, subsequently, the entire group of 60 birth providers. This education was repeated in 2013, with the update to the CPOE order-set.

The standardized practice and orders introduced with the first system-wide education in 2006 empowered nurses to discontinue oxytocin treatment without a separate order. This change helped remove hierarchical barriers and support an interdisciplinary approach to care. Nurses' autonomy to suspend oxytocin treatment demonstrates the collaboration and trust established among the birth providers. Working as part of a team, nurses are encouraged to use critical thinking skills to assess and make decisions about patient care in close collaboration with the birth provider.

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Outcome Measures

In 2006, prior to a written order-set, 73% of orders reviewed followed the standard recommendations. In 2007, following the advent of a written order-set that exactly mirrored an update of the standing protocol, there was 95% compliance with the standard recommendations for oxytocin use (p = 0.007), when comparing 2006 versus 2007. In 2009, after the written order-set had been in place for 2 years, with no ongoing formal education, 82% of cases observed followed the standard approach. In 2010, an electronic order-set was put in place (CPOE). This order-set did not mirror all aspects of the protocol and allowed for “customization” of the orders by the provider. In 2011, it was found that 57% of cases observed followed the consensus standard. In 2013, after the revision of the electronic order-set to reflect the previous evidence-based, consensus-driven order-set, 100% of the cases observed followed the consensus standard (p < 0.001) when comparing 2006 versus 2013 (Table 2, Figure 2).

Table 3

Table 3

Figure 2

Figure 2

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Balancing Measures

Overall, there were 152 cases in which the protocol was followed (Table 2); 141 (92.7%) did not exceed a dose of 20 mU/min, with 11 (7.2%) cases in which the dosing did exceed 20 mU/min. By comparison, in the 32 cases where the protocol was not followed (Table 2), 16 (50%) exceeded a dose of 20 mU/min (p < 0.001).

Figure

Figure

Mean hours from oxytocin onset to birth were as follows: 2006: 8.54 hours (SD 4); 2007: 7.93 hours (SD 3.7); 2009: 7.54 hours (SD 3.1); 2011: 8.99 hours (SD 4); and 2013: 7.38 hours (SD 3.5). There was a trend toward lower mean hours to birth in years in which there was improved compliance with the standardized approach, with the peak number of hours to birth correlating with the year of poorest compliance in 2011 (Figure 2). A significant difference in hours to birth from oxytocin start time was found between those patients in whom the standard approach was followed compared with those in which it was not (p < 0.001).

Figure 3

Figure 3

The maximum dose of oxytocin was categorized into four ranges: 2 -7 mU/min, 8 -13 mU/min, 14 -20 mU/ min, and more than 20 mU/min. It was expected that the higher the range of dosing, the more potential existed for untoward effects of oxytocin. A trend toward fewer patients being given doses more than 20 mU/ min emerged over the years of observation (Figure 3a), and a significant difference was seen between those patients for whom the standard approach was followed in comparison to those for whom was not (p < 0.001).

The mean of the maximum dose in each time period was as follows: 2006: 14.27 mU/min (SD 8.2); 2007: 13.20 mU/min (SD 7.2); 2009: 13.21 mU/min (SD 6.9); 2011: 13.07 mU/min (SD 6.9); and 2013: 11.10 mU/min (SD 7) (Figure 3b). There was a trend toward lower means each year, with a significant difference between those patients in which the standard approach was followed compared with those in which it was not (p < 0.001).

There were four infants in which the 1-minute Apgar score was less than 3; three of these were in the 2011 group and one in the 2013 group. When comparing all years, there were significantly more infants with a 1-minute Apgar score less than 5 in 2011 (year of poorest compliance) when compared with all other years (p = 0.002). No difference was observed over the years when comparing the cesarean birth rate.

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Discussion

This QI project was successful in standardizing oxytocin use during labor and birth across multiple obstetric providers and interdisciplinary staff caring for women in a community hospital. Barriers were evident early in 2006, which precluded consensus among providers when an oxytocin dosing recommendation was first suggested. These included providers finding protocols and guidelines too restrictive if not already part of their practice. This problem was complicated by the lack of consensus between providers and the applicable clinical literature regarding specific dosing of oxytocin at the time. An overarching barrier to collaboration involved birth providers at this community hospital ranging across competing provider groups with varied alliances to other institutions and practices. Through collaboration, use of evidence-based practice, and the Delphi Technique, nurses and community providers united in a practice change that focused on standard practice and patient safety.

During this project, the nomenclature and definitions surrounding the use of oxytocin changed significantly. The 2005 ACOG Compendium quoted the 1999 Practice Bulletin that stated, “There is no uniform definition of uterine hyperstimulation...either a series of single contractions lasting 2 minutes or more or a contraction frequency of five or more in 10 minutes.” In contrast, the 2009 Practice Bulletin from ACOG defines tachysystole as “more than five contractions in 10 minutes, averaged over a 30-minute window” and further states “The terms hyperstimulation and hypercontractility are not defined and should be abandoned” (ACOG, 2009b). These kinds of changes in the authoritative literature supporting appropriate use of a high-risk medication are not immediately assimilated into clinical practice without an evidence-based protocol such as described by the Institute of Medicine (2001) and Morris et al. (2011).

Through the modified Delphi process at the consensus building event, the participants agreed that protocols have value in that they help the nursing staff carry out the obstetric provider's intentions and may provide protection against future litigation. It was concluded that collaboration between nurses and birth providers working together to write a protocol could yield greater compliance. Individual birth provider autonomy was respected by allowing orders to be written that were outside the protocol, provided that the explanation for this variance was documented in the medical record. Although communication challenges are common among a diverse group of healthcare providers, the event allowed an introduction of a common language around fetal heart rate and uterine contraction monitoring between nurses and birthing providers, promoting collaboration concerning dosing changes.

Labor and delivery staff observed an initial improvement in adherence to recommended oxytocin dosing after the consensus protocol was initiated. However, they noted that compliance to the standard approach seemed to decrease after initiation. The observed decrease was reported to the Perinatal Safety Committee and triggered a follow-up review showing providers were less compliant over time. This decline in protocol success was compounded when CPOE was introduced, which required specific orders to be entered with each encounter without careful direction toward the accepted standards. When the CPOE protocol was revised and standardized to match the original consensus protocol, adherence to recommended dosing increased to 100%. As compliance to the protocol improved, so did the balancing measures of maximum dose of oxytocin and time to birth. These measures were chosen based on the bias that “restricting” the way oxytocin could be administered would result in longer periods from initiation of induction to birth; however, the opposite was found. Other safety measures such as the cesarean birth rate and Apgar scores were unchanged. These findings are consistent with previous reports on the effect of standardization of oxytocin use (Clark, Belfort, Byrum, et al.; 2008; Hayes & Weinstein, 2008; Rhinehart-Ventura et al., 2014; Sundin et al., 2018). Recent guidelines have been published that illustrate the use of protocols for oxytocin dosing to produce greater efficacy and patient safety (ACOG, 2011; California Maternal Quality Care Collaborative, 2018).

As projects and priorities shifted, intensive data were no longer collected for this project. Since the conclusion of the data collection described here, there have been periodically noted deviations from the protocol. When drilling down into the cases, the task force found that these deviations have often been related to EMR changes, which has resulted in continuing education and monitoring of this effect.

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Conclusion

The goal of this QI project was to create a consensus-driven, evidence-based protocol to guide the use of oxytocin. This goal was accomplished using a modified Delphi Technique to help build camaraderie and consensus, a sense of shared purpose, and attention to supportive evidence within the medical literature. Despite this success, barriers to the consistent use of this protocol presented over time. The utility of ongoing QI measurements after the “completion” of a project is demonstrated within this report. An important lesson learned is that a standardization process must be integrated into the EMR to become a sustained part of a practice culture. It is important to note, however, that the EMR can present opportunities for providers to deviate from standard protocols without recording their rationale for this deviation in the progress notes. Therefore, continued policing of unintended variation is needed.

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Acknowledgments

The authors would like to thank the members of their multidisciplinary team over the years of this project: Patricia A. Reuter, MSN, RNC-NIC; April Crouch, BSN, RN; Corinna Cooper, MD; Anne Daniels, BSN, RN; Shana Hett, BSN, RN; Sally Jordan, RN, RNC-OB; Denise Martinek, MSN, RN; Laurie McElwain, RN, CBE; Debra Ohnoutka, MHA, BSN, NEA-BC; Dawn Caspers BS, Pharm RPH; Nancy Raile, BSN, RN; and Eva Shay, BSN, RN. Without them, this project could have never been successful. The authors' work allowed them all to experience and demonstrate the power of multidisciplinary collaboration.

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                                                          Keywords:

                                                          Collaborative learning; Evidence-based medicine; Oxytocin; Quality improvement; Shared learning; Standardization

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