Shi-Fn Hn, Hong-Xi Ren, Xiu-Jun Wng, Xio-Ding Yue, Si-Yu Dou
aSchool of Nursing, Shanxi Medical University, Taiyuan, Shanxi 030001, China
bFirst Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001, China
Abstract: Objective: To investigate the necessary eligibility criteria for prescriptive authority for midwives, gather suggestions from experts on training content for prescriptive authority for midwives, and explore the scope of practice of their prescriptive authority in certain circumstances. The results of this study could serve as a reference for the development of policies on prescriptive authority for midwives.Methods: Based on a literature search and semistructured interviews, a modif i ed Delphi method was fi rst used to conduct 2 rounds of expert consultation on eligibility criteria and training content for prescriptive authority for midwives. This stage included nursing experts (20) and medical experts (16) engaged in midwifery in many tertiary Grade A hospitals in China. Subsequently, consultation on the scope of practice of prescriptive authority for midwives was conducted with nursing experts (18) and medical experts (14)engaged in midwifery in many tertiary Grade A hospitals in China. The suggestions from the experts were analyzed using statistical methods to conf i rm the eligibility criteria for prescriptive authority, training content, circumstances, scope of practice for prescriptive authority, and the prescription forms.Results: Among the consulted experts, 70.59% (the highest acceptance rate) considered an undergraduate degree to be the minimum educational requirement for midwives to be eligible for prescriptive authority, 85.29% (the highest acceptance rate) considered the supervisor nurse to be the minimum technical position experience necessary for midwives to be eligible for having prescriptive authority, and 50% (the highest acceptance rate) considered 5 years to be the minimum number of years of experience in the specialty for midwives to be eligible for prescriptive authority. The applicants should at least be practicing at Grade C hospitals, which was the consensus among 91.18% of the consulted experts. Among the consulted experts, 100%, 100%, 97.06%, 94.12%, and 94.12%agreed that the applicants should have knowledge in pharmacology, laws and ethics, nursing, diagnostics, and midwifery, respectively.The consulted experts conf i rmed 22 related course topics and identif i ed 6 specif i c circumstances in which the midwives could partially practice prescriptive authority, including uterine atony, excessive uterine contraction, postpartum hemorrhage, premature rupture of fetal membranes, normal labor, and neonatal asphyxia. Under these 6 circumstances, the consulted experts commonly agreed that there were 20 medication prescriptions and 13 auxiliary examination prescriptions that could be prescribed by midwives.Of these prescriptions, 51.5% were independent prescriptions, 30.3% were protocol prescriptions, and the remaining 18.2% were both independent and protocol prescriptions.Conclusions: Midwives who have an undergraduate degree, supervisor nurse position, and 5 years of practice in Grade C hospitals are considered eligible to apply for prescriptive authority. Partial prescriptive authority could be granted after regulated training in fundamental theories and practices, which could improve the independence and professionalism of midwifery.
Keywords: Delphi study · midwife · eligibility criteria · training content · circumstances · scope of practice · prescriptive authority· prescription forms
Recent decades have seen tremendous developments in midwifery, particularly in developed countries in Europe and North America. With continuous improvements in the prof i ciency of midwives and increases in the scope of practice, midwives have become increasingly more skillful and independent. Midwives play a critical role in the medical care system, especially in maternal and child healthcare. They are the backbone that ensures the health of mothers and children. Currently, most countries recognize midwives as professional healthcare providers who deliver continuous services for pregnancy, labor, and postpartum periods.Obstetricians are primarily responsible for managing parturient women at high risk.1In recent decades,increasingly more nations have granted prescriptive authority to nurses and midwives, including the United Kingdom, Australia, Canada, New Zealand, Ireland, the Netherlands, and Sweden.2The prescriptive authority of nurses was the most-discussed topic at the 2017 International Council of Nurses Congress. The studies suggested that prescriptive authority allows nurses and midwives more independence in their professions and can enhance job satisfaction, improve the status of nurses, and relieve the burden on physicians.3Physicians are then allowed more time to provide care to those with severe conditions.4Furthermore, the quality of medical care can be improved, and the waiting time reduced. Increasing prescriptive authority for midwives improves care for childbearing people because it increases access to care, streamlines care, and ensures that each person is getting the medical care that from the provider they are seeing. These changes benef i t.
In China, nurses in Hong Kong are given limited prescriptive authority. However, nurses in other regions of China are granted no prescriptive authority.5In August 2017, Anhui Province was selected to be the pilot province for National Medical Reform. Anhui Province was the fi rst to have senior nurse practitioners in its communities. There were 78 senior nurses deployed to 22 community health centers.6This ground-breaking approach created paths for nurses to apply for prescriptive authority. Prescriptive authority for nurses is necessary.Recently, to provide individualized medical care, outpatient midwifery services have been developed in various regions. The care provided by midwives evolved from parturient-period-focused to continuous care. China is a country with a large population and a high birth rate.The universal 2-child policy placed greater demands on maternal and childcare. Therefore, granting prescriptive authority to midwives is necessary. However, there are roadblocks to implementing prescriptive authority for midwives, including def i ning the eligibility criteria,training content, scope of practice, and prescription forms. Therefore, it is urgent to gather suggestions on the eligibility criteria, training content, and scope of practice for prescriptive authority.
In our study, a literature search was performed to gather information on eligibility criteria and training experience for prescriptive authority in other nations.This information was then integrated into the current medical environment, the status of practicing nurses,and midwives' educational background in China. The integrated background knowledge was then used to explore the eligibility criteria, training content, and scope of practice for prescriptive authority for midwives. The results of our study could promote the enactment of prescriptive authority for midwives and provide a reference for future policy development.
The Delphi method was used in this study. A group of experts (including midwives and obstetricians) participated in a 2-round anonymous consultation on eligibility criteria, training content, and scope of practice for prescriptive authority for midwives. A consensus was achieved based on suggestions provided by the participants.
To ensure a thorough understanding of the research content, 2 groups of experts were included: (1) nurses engaged in midwifery and (2) medical experts who specialized in midwifery. The inclusion criteria were as follows: (1) associate chief physician, co-chief superintendent nurse, or above or equivalent positions; (2) 10 years or more of experience in midwifery; (3) undergraduate degree or above; and (4) good work ethic and volunteered to participate. Participants were required to satisfy 2 of the fi rst 3 criteria. Considering the universality and representativeness of participants, purposive sampling was employed. There were 38 nursing specialists and 30 medical experts (including hospital administrators)selected as participants from Shanxi, Shaanxi, Anhui,Beijing, and Guangdong, China.
The study included the following steps: (1) composition of a questionnaire based on the integrated information from the literature search on prescriptive authority for midwives in other nations and current medical practice in China; (2) fi rst round of the survey using the Delphi method; (3) analysis of data from the fi rst round of the survey; (4) second round of the survey using the Delphi method; (5) analysis of data from the second round of the survey; and (6) reaching consensus among the participating experts.
2.3.1. Step 1: Delphi questionnaire preparation
2.3.1.1. Round 1
Relevant literature and official sites regarding prescriptive authority for midwives were explored. Based on the regulations of eligibility criteria and scope of practice employed by the United Kingdom and Australia, reviewing the relevant studies and combining the current education, practice, and development status of midwives in China, the eligibility criteria for prescriptive authority were preliminarily identif i ed. he studies reviewed included “Study on the Eligibility Criteria for Prescriptive Authority for Nurses and the Prescriptive-Authority-Related Courses for Undergraduate Curriculum,” “Study on Aptitude of Supervising Nurse for Grading Nursing Care by Peer Review,”7and “A Primary Study on Applying the Delphi Method for Screening Authentication and Evaluation Indexes of Clinical Nursing Specialists”.8The training content, scope of practice, drugs and auxiliary examination covered by prescriptive authority were identif i ed by referencing college textbooks such as Obstetrics and Gynecology,9Obstetrical Nursing,10Obstetrics Clinical Work Handbook, and Obstetrician Prescription.
To avoid errors caused by subjective bias and lack of experience, a semistructured interview format was employed. To improve the questionnaire, the interview was conducted with 3 co-chief superintendent nurses and 2 associate chief physicians who had more than 10 years of experience in obstetrics care. Based on the interview, the “years of clinical work” item in the“Questionnaire for Prescriptive Authority for Midwives”was modif i ed to “years of obstetrics experience.” The consulted experts suggested that years of clinical practice and position title are redundant indicators. The term“years of obstetric experience” should be used to indicate the clinical experience and skills needed for a midwife to be eligible to apply for prescriptive authority. The modif i ed questionnaire was titled “Questionnaires on the Eligibility Criteria and Training Content for Prescriptive Authority for Midwives (for Experts)” and was used in the fi rst round of the survey.
In other nations, midwives provide care before, during, and after labor and are granted prescriptive authority. In China, the care provided by midwives is limited to the parturient stage. The scope of care provided by midwives remains imprecisely def i ned. Hence, considering the status of midwives in China, the scope of our study on prescriptive authority for midwives is limited to the drugs and prescription forms that can be prescribed by midwives when assisting a patient preparing for labor in a maternity ward and during labor.Furthermore, we def i ned the care that can be provided by midwives. Our literature search revealed 3 forms of prescription: independent prescription, compensatory prescription, and protocol prescription. Compensatory prescriptions are more applicable to patients with chronic conditions. The care provided by midwives in China does not involve chronic condition management. Therefore, compensatory prescriptions were not considered in our study, and the focus was placed on independent prescriptions and protocol prescriptions.To avoid issues such as subjective bias and lack of experience, a semistructured interview was used. Six physicians and midwives with more than 10 years of obstetrics practice were interviewed to further improve the questionnaire. Based on the interview, 3 conditions (placental abruption, placenta previa, and uterine rupture) were eliminated. The experts suggested that patients with these 3 conditions undergo surgical treatment and are not treated in maternity wards.Since midwives do not participate in those processes,these conditions should not be considered. In addition,“prolonged pregnancy” was replaced with “induced labor” because the interviewed experts suggested that prolonged pregnancy is one of the conditions that require inducing labor. The term “induced labor”can provide better exposure of conditions that can be covered by midwives. The modif i ed questionnaire was titled “Questionnaires on the Scope of Practice of Prescriptive Authority for Midwives under Certain Circumstances (for Experts)” and used in the fi rst round of the survey.
2.3.1.2. Round 2
After the fi rst round of the survey, a second questionnaire was developed based on the suggestions, screening standards, and group discussions of the participants in the fi rst survey. The revised questionnaire was then titled “Questionnaires on the Eligibility Criteria and Training Content for Prescriptive Authority for Midwives(for Experts)” There were 1 open-ended question and 7 closed-ended questions. There were 5 courses and 23 training topics included in the questionnaire for the second round of the survey. In the modif i ed “Questionnaires on the Scope of Practice of Prescriptive Authority for Midwives under Certain Circumstances (for Experts),”the “Survey on Special Conditions” had 6 conditions,the “Survey on Scope of Practice in Specif i c Conditions”included 21 drugs and 12 auxiliary examinations, and the “Survey on Care Provided by Midwives” included 17 tasks.
2.3.2. Step 2: Delphi Round 1
Electronic and paper copies were available for the fi rst round of the survey. The participants were requested to select the following: (1) eligibility criteria for prescriptive authority for midwives: education, position, years of experience; (2) training content for prescriptive authority; (3) survey on acceptance for midwives to practice prescriptive authority in 9 specif i ed conditions. The levels of acceptance were “agree, somewhat agree,neutral, somewhat disagree, and disagree” and were expressed by 5, 4, 3, 2, and 1, respectively; (4) scope of practice (drugs and auxiliary examinations) in specif i c conditions and prescription forms; (5) survey on the experts (included familiarity with the topic and their bases for suggestions).
2.3.3. Step 3: Data analysis of Delphi Round 1
Hasson et al.11suggested that the acceptance rate of an item among experts should be at least 51%. Items with <51% acceptance were eliminated. Most researchers agreed that the consensus among experts should be expressed in percentages. Based on the standards,2 items were eliminated from the eligibility criteria survey, “hospital ownership” and “hospital type.” The majority of the participating experts agreed that the type of ownership and the nature of the hospital were not critical to the eligibility criteria of applicants. There were no additional items in this section of the survey. For the training topics in pharmacology, “pharmacodynamics,pharmacokinetics and medications for complications in normal and abnormal labors” were eliminated, and“interpretation of medication instructions” was added.For diagnostics, “inquiry and differential diagnosis”was eliminated. For introductory courses, “Origin and Development of Prescriptive Authority for Midwives and Development and Policy of Midwifery” was eliminated,and “Collaborative Practice with Physicians” was added.For scope of practice in specif i c conditions, some of the items were eliminated, including “induced labor,intrapartum fever, gestational hypertension, and amniotic fl uid embolism.” Based on the participants' suggestions, “neonatal asphyxia” was added. For prescription drugs, “fentanyl and codeine” were eliminated because these 2 drugs are currently not used in labor. Based on the suggestions, “electrolyte examination” for postpartum hemorrhage, “epinephrine, naloxone, blood oxygen analysis, blood sugar monitoring” for neonatal asphyxia and “vitamin K1” were added.
2.3.4. Step 4: Delphi Round 2
After the fi rst survey round, a second questionnaire was developed based on the suggestions, screening standards, and group discussions. Electronic and paper copies were available for the second round of surveys. Participants were instructed to provide opinions on the following: (1) Eligibility criteria for prescriptive authority for midwives: education, position, and years of experience. (2) Training content from the 23 topics in 5 courses. (3) Level of acceptance for midwives to practice prescriptive authority in the 6 specif i ed conditions. (4) The scope of practice(21 drugs and 12 auxiliary examinations) of prescriptive authority for midwives and the prescription forms.(5) Level of acceptance of the 17 work contents of midwives.
2.3.5. Step 5: Data analysis of Delphi Round 2
Based on the second round of surveys, the eligibility criteria for prescriptive authority were determined by the highest acceptance rate. Course contents were screened by a threshold of 70% (acceptance rate) and “Interpretation of medication instructions”was eliminated. For the scope of practice, any items with less than an 80% acceptance rate were eliminated. Therefore, “pituitrin and ergometrine” were removed from the list. Prescription forms (high: low)≥1.5 indicated a preferred choice by a large number of participants and indicated that 2 prescription forms were close.
The positive coefficient of participants is often measured by survey response rate. A higher response rate indicates a higher positivity of the expert. A 70% response rate is considered highly positive (Tables 3 and 4).
The Cr of an expert is determined by the coefficient of determination (Ca) and familiarity (Cs). Typically, a consultation result with an authority coefficient >0.70 is considered reliable. The accuracy of a prediction increases with the increase in the expert authority coefficient(Tables 5 and 6).12
Table 1. Basic information on the experts participating in the survey on eligibility criteria and training content for prescriptive authority formidwives
Table 2. Basic information on the experts participating in the survey on scope of practice of prescriptive authority for midwives in specif i c conditions
Table 3. Survey on the eligibility criteria and training content for prescriptive authority for midwives
Table 4. Survey for conf i rming the scope of practice of prescriptive authority for midwives in specif i c conditions
The convergence of experts' opinions is expressed in terms of the mean importance value and the coefficient of variation.13The mean importance value of each item listed in Tables 10 and 11 was >3.5, and the coefficient of variation was <0.25. Such results suggested that the convergence of experts' opinions was high.
The concordance of experts' opinions was expressed in the coefficient of concordance (Kendall's W), which ranged from 0 to 1. A higher value indicates a higher concordance, and the experts' opinions were more consistent with one another.14The coefficient of concordance was calculated using the coefficient of concordance equation. SPSS 22.0 was used for the signif i cance Chi-squared test. P < 0.05 indicates that the coefficient of concordance was signif i cant, the experts' opinions were well-coordinated, and the results were reliable.15In the study on the scope of practice of prescriptive authority for midwives, the coefficient of concordance of the fi rst round of the survey was 0.207 with P < 0.001; the coefficient of concordance of the second round of the survey was 0.489 with P < 0.001.The results indicated that the concordance among the experts on the conditions for practicing prescriptive authority was high.
Table 5. Study on the eligibility criteria and training content forprescriptive authority for midwives
Table 6. Survey on the scope of practice of prescriptive authority for midwives in specif i c conditions
Table 7. The consensus on the minimum acceptable eligibility criteria for prescriptive authority for midwives (n = 34)
In our study, the conditions were screened using the mean value and the coefficient of variation. Conditions were maintained when satisfying the criteria of having a value >3.5 and coefficient of variation < 0.25. There were 6 conditions maintained on the fi nal list: uterine atony, excessive uterine contraction, postpartum hemorrhage, premature rupture of fetal membranes, normal labor, and neonatal asphyxia.
Table 8. The consensus on the training courses for prescriptive authority for midwives (n = 34)
Table 9. The consensus on the training topics for prescriptive authority for midwives (n = 34)
Table 10. Statistics on the acceptance of conditions for midwives practicing prescriptive authority (Round 1)
Table 11. Statistics on the acceptance of conditions for midwives practicing prescriptive authority (Round 2)
To ensure the reliability of the results, 2 rounds of the survey using the Delphi method were conducted based on the literature search and semistructured interview results. The Delphi method is simple and easily implemented. Experts are allowed to express opinions without inf l uence from others. The results obtained are more objective and, thus, more scientif i c and applicable.16Experts in consultation should have authority and representativeness and be well recognized. Therefore, when recruiting experts, fi elds of expertise, years of experience, and positions should be considered in addition to the clinical fi eld. To increase the reliability of consultation, the participating experts should have adequate position and years of experience in the fi eld of interest and should volunteer to participate. The reliability of experts' opinions on the surveyed items was examined using statistical analysis of the authoritative, enthusiastic, and concordance levels. The results indicated that the reliability was high.
According to the study results, the education, years of obstetric practice, and position requirements were high. In the United States, midwifery has become an independent profession. Midwifery is an independent position. The midwives with prescriptive authority are certif i ed nurse midwives (CNMs) and certif i ed midwives(CMs). The educational background of CNMs and CMs are different. CNMs are granted prescriptive authority in 50 states while CMs are granted prescriptive authority in 2 states and can practice in 5 states. In China,there is no distinct differentiation between midwives and practicing nurses. Based on the results reported in“Study on the Eligibility Criteria for Prescriptive Authority for Nurses and Prescriptive-Authority-Related Courses for Undergraduate Curriculum,” the midwives with working experience in Grade C hospitals, an undergraduate degree, a supervisor nurse position, and 5 years of clinical experience are eligible for prescriptive authority.There are several reasons for this. First, granting prescriptive authority to nurses and midwives is a highly controversial issue. Midwifery education in China differs from that in European and American countries.17Therefore, the eligibility criteria for prescriptive authority are stringent to ensure that the applicants are truly qualif i ed to provide prescriptions. Second, due to the medical care environment in China, there are relatively fewer studies on related topics. Therefore, the theoretical foundation is not profound. To be responsible to patients and the practicing midwives, the eligibility criteria for prescriptive authority for midwives must be high.
Table 12. Scope of practice of prescriptive authority for midwivesin specif i c conditions
In Australia, midwives are provided clinical opportunities during their undergraduate education. The practices include physiology, pharmacology, and communication,enabling the graduated midwives to suggest appropriate medications for women. To obtain prescriptive authority,midwives are required to complete additional training,which includes diagnostics, pharmacology, laws, and administrative framework. The training also highlights the importance of collaboration with other medical care providers involved in maternal and fetal care.18This education project was overseen by four colleges recognized by the Nursing and Midwifery Board of Australia(NMBA). Upon successful completion of courses, midwives can register with the Australian health administration to obtain prescriptive authority. Once the application is approved, midwives can then apply for prescription authority from the Pharmaceutical Benef i ts Scheme(PBS). The training topics for prescriptive authority for midwives in our study are similar to the training content for the midwives in Australia. Because the midwives in China are not granted prescriptive authority, compared with Australia, the prescription content certif i cation in China remains inadequate.
Comparing the results of our study with the scope of practice of prescriptive authority for midwives in the USA, prescriptions there that can be provided by midwives include drugs, medical equipment, physical examinations, laboratory tests, and diagnostic examinations. The prescription content determined in our study includes drugs and auxiliary examinations, which is consistent with the scope of practice in the USA.Regarding the drugs in the scope of practice, there is not yet a federal standard in the USA. The medications and procedures that can be prescribed by midwives are governed by the states and the standards are different in each state. However, the scope of prescribing drugs is largely the same: midwives can prescribe all prescriptive drugs and some specif i c controlled substances.For example, in Texas, certif i ed nurse midwives are granted the authority to prescribe prescription drugs and Schedule III-IV controlled substances. In California, certif i ed nurse midwives can prescribe all prescription drugs and Schedule II-V controlled substances. In our study, using surveys of the experts, a consensus was developed on the drugs that can be prescribed by midwives, which include a few commonly used obstetrical drugs such as oxytocin, ergometrine, and magnesium sulfate. For controlled substances, midwives can prescribe pethidine and lidocaine. The drugs that can be prescribed by midwives are limited. In the USA,the requirements for midwives to be eligible for prescriptive authority are strict. Midwives must complete the accredited courses and examinations. Additionally, they must register with the accrediting agencies and complete a graduate degree. In China, there are issues such as the relatively low education level of midwives and their complicated education backgrounds that some of them graduated from nursing specialty and some graduated from midwifery specialty.19The prof i ciency of midwives requires further development.The limited list of drugs to be prescribed by midwives is more practical and more acceptable as part of the scope of prescriptive authority.
The acceptance rates among the experts were low on allowing midwives to treat “intrapartum fever, gestational hypertension, and amniotic fl uid embolism.” In the experts' opinions, intrapartum fever can have various causes. Immediate diagnosis of the causes of the fever and providing appropriate medications are diffi-cult. Additionally, during labor, a high fever is dangerous to the mother and the child. Gestational hypertension imposes a certain level of risk and is one of the primary causes of death of the mother and the child. Amniotic fl uid embolism is a rare and dangerous complication that can cause a death rate as high as 20%-60%, and it ranks fi rst to third in the global ranking of maternal deaths. Parturient women can lose consciousness, and the condition can lead to death in a short period of time.Therefore, a rapid decision must be made by the physicians, and the resuscitation should be a result of teamwork among different disciplines. These 3 conditions are complicated and high risk. Therefore, in the experts'opinions, midwives may not be capable of the decision making and prescribing of medications in these situations. The experts had a low acceptance of “induced labor” because the interpretation of the indicators, conditions, timing, method, and the monitoring is highly specialized. There is also high risk with induced labor and often disagreement among physicians on whether induced labor is necessary. The medications used for induced labor are also quite risky. Midwives may not be capable of interpreting indicators and deciding on a method for induced labor.
The experts suggested adding “neonatal asphyxia”because it is one of the most commonly observed conditions and causes of death among infants in the perinatal period.20During labor, midwives are the ones who assist with the delivery and fi rst provide care to newborns.In cases of neonatal asphyxia, other than the obstetricians, midwives must participate in the resuscitation. If the obstetrician cannot provide care in a timely manner,midwives should be capable of providing fi rst aid to the newborn to avoid delayed treatment.
Two rounds of consultation with experts were performed using the modif i ed Delphi method. Based on the surveys, we suggest that the eligibility criteria for prescriptive authority for midwives should be as follows: undergraduate degree, supervisor nurse, and 5 years of experience practicing midwifery in Grade C hospitals. The training content should include 5 courses that cover 22 topics: pharmacology, diagnostics, laws and ethics, nursing, and midwifery. Midwives should be allowed the protocol prescription of prescriptive authority in the following 6 conditions: uterine atony, excessive uterine contraction, postpartum hemorrhage, premature rupture of fetal membranes, normal labor, and neonatal asphyxia. The authority coefficient was high among the participating experts. The consensus was also high. The results obtained are reliable.
Currently, there are 20 nations in which midwives have prescriptive authority.21There is also a gradual increase in the number of nations granting prescriptive authority to midwives. It has become a common trend in the healthcare fi eld. In China, although senior nurses are given some prescriptive authority in Anhui Province, the scope of practice is limited to OTC. Currently,prescriptive authority is not yet granted to midwives in China. Additionally, studies on the scope of practice of prescriptive authority for midwives are not being conducted. This study explored the eligibility criteria,training content, and scope of practice for prescriptive authority for midwives. The results of this study can provide a foundation for future policy development and can be a reference for future trial implementation of prescriptive authority for midwives. We suggest that the scope of work of midwives should be better def i ned, which can improve the independence and professionalism of midwifery, strengthen the midwifery team, and provide better care to mothers and children.
The researchers thank all the participants of the Delphi procedure for their contribution and commitment.
This study was approved by the Ethics Committee of First Hospital of Shanxi Medical University. Written informed consent was obtained from all of the experts.
The authors declare that they have no conf l icts of interest.