Molly F. Battistelli

Safety of Aspiration Abortion Performed by Nurse Practitioners, Certified Nurse Midwives, and Physician Assistants Under a California Legal Waiver

OBJECTIVES We examined the impact on patient safety if nurse practitioners (NPs), certified nurse midwives (CNMs), and physician assistants (PAs) were permitted to provide aspiration abortions in California. METHODS In a prospective, observational study, we evaluated the outcomes of 11 487 early aspiration abortions completed by physicians (n = 5812) and newly trained NPs, CNMs, and PAs (n = 5675) from 4 Planned Parenthood affiliates and Kaiser Permanente of Northern California, by using a noninferiority design with a predetermined acceptable risk difference of 2%. All complications up to 4 weeks after the abortion were included. RESULTS Of the 11 487 aspiration abortions analyzed, 1.3% (n = 152) resulted in a complication: 1.8% for NP-, CNM-, and PA-performed aspirations and 0.9% for physician-performed aspirations. The unadjusted risk difference for total complications between NP-CNM-PA and physician groups was 0.87 (95% confidence interval [CI] = 0.45, 1.29) and 0.83 (95% CI = 0.33, 1.33) in a propensity score-matched sample. CONCLUSIONS Abortion complications were clinically equivalent between newly trained NPs, CNMs, and PAs and physicians, supporting the adoption of policies to allow these providers to perform early aspirations to expand access to abortion care.

Standardizing the classification of abortion incidents: the Procedural Abortion Incident Reporting and Surveillance (PAIRS) Framework

OBJECTIVES To develop and validate standardized criteria for assessing abortion-related incidents (adverse events, morbidities, near misses) for first-trimester aspiration abortion procedures and to demonstrate the utility of a standardized framework [the Procedural Abortion Incident Reporting & Surveillance (PAIRS) Framework] for estimating serious abortion-related adverse events. STUDY DESIGN As part of a California-based study of early aspiration abortion provision conducted between 2007 and 2013, we developed and validated a standardized framework for defining and monitoring first-trimester (≤14weeks) aspiration abortion morbidity and adverse events using multiple methods: a literature review, framework criteria testing with empirical data, repeated expert reviews and data-based revisions to the framework. RESULTS The final framework distinguishes incidents resulting from procedural abortion care (adverse events) from morbidity related to pregnancy, the abortion process and other nonabortion related conditions. It further classifies incidents by diagnosis (confirmatory data, etiology, risk factors), management (treatment type and location), timing (immediate or delayed), seriousness (minor or major) and outcome. Empirical validation of the framework using data from 19,673 women receiving aspiration abortions revealed almost an equal proportion of total adverse events (n=205, 1.04%) and total abortion- or pregnancy-related morbidity (n=194, 0.99%). The majority of adverse events were due to retained products of conception (0.37%), failed attempted abortion (0.15%) and postabortion infection (0.17%). Serious or major adverse events were rare (n=11, 0.06%). CONCLUSIONS Distinguishing morbidity diagnoses from adverse events using a standardized, empirically tested framework confirms the very low frequency of serious adverse events related to clinic-based abortion care. IMPLICATIONS The PAIRS Framework provides a useful set of tools to systematically classify and monitor abortion-related incidents for first-trimester aspiration abortion procedures. Standardization will assist healthcare providers, researchers and policymakers to anticipate morbidity and prevent abortion adverse events, improve care metrics and enhance abortion quality.

The effect of facility characteristics on patient safety, patient experience, and service availability for procedures in non-hospital-affiliated outpatient settings: A systematic review

Background Over recent decades, numerous medical procedures have migrated out of hospitals and into freestanding ambulatory surgery centers (ASCs) and physician offices, with possible implications for patient outcomes. In response, states have passed regulations for office-based surgeries, private organizations have established standards for facility accreditation, and professional associations have developed clinical guidelines. While abortions have been performed in office setting for decades, states have also enacted laws requiring that facilities that perform abortions meet specific requirements. The extent to which facility requirements have an impact on patient outcomes—for any procedure—is unclear. Methods and findings We conducted a systematic review to examine the effect of outpatient facility type (ASC vs. office) and specific facility characteristics (e.g., facility accreditation, emergency response protocols, clinician qualifications, physical plant characteristics, other policies) on patient safety, patient experience and service availability in non-hospital-affiliated outpatient settings. To identify relevant research, we searched databases of the published academic literature (PubMed, EMBASE, Web of Science) and websites of governmental and non-governmental organizations. Two investigators reviewed 3049 abstracts and full-text articles against inclusion/exclusion criteria and assessed the quality of 22 identified articles. Most studies were hampered by methodological challenges, with 12 of 22 not meeting minimum quality criteria. Of 10 studies included in the review, most (6) examined the effect of facility type on patient safety. Existing research appears to indicate no difference in patient safety for outpatient procedures performed in ASCs vs. physician offices. Research about specific facility characteristics is insufficient to draw conclusions. Conclusions More and higher quality research is needed to determine if there is a public health problem to be addressed through facility regulation and, if so, which facility characteristics may result in consistent improvements to patient safety while not adversely affecting patient experience or service availability.

Religious hospital policies on reproductive care: what do patients want to know?

Background Religious hospitals are a large and growing part of the American healthcare system. Patients who receive obstetric and other reproductive care in religious hospitals may face religiously‐based restrictions on the treatment their doctor can provide. Little is known about patients’ knowledge or preferences regarding religiously restricted reproductive healthcare. Objective(s) We aimed to assess women’s preferences for knowing a hospital’s religion and religiously based restrictions before deciding where to seek care and the acceptability of a hospital denying miscarriage treatment options for religious reasons, with and without informing the patient that other options may be available. Study Design We conducted a national survey of women aged 18–45 years. The sample was recruited from AmeriSpeak, a probability‐based research panel of civilian noninstitutionalized adults. Of 2857 women invited to participate, 1430 completed surveys online or over the phone, for a survey response rate of 50.1%. All analyses adjusted for the complex sampling design and were weighted to generate estimates representative of the population of US adult reproductive‐age women. We used χ2 tests and multivariable logistic regression to evaluate associations. Results One third of women aged 18–45 years (34.5%) believe it is somewhat or very important to know a hospital’s religion when deciding where to get care, but 80.7% feel it is somewhat or very important to know about a hospital’s religious restrictions on care. Being Catholic or attending religious services more frequently does not make one more or less likely to want this information. Compared with Protestant women who do not identify as born‐again, women of other religious backgrounds are more likely to consider it important to know a hospital’s religious affiliation. These include religious minority women (adjusted odds ratio, 2.17; 95% confidence interval, 1.11–4.27), those who reported no religion/atheist/agnostic (adjusted odds ratio, 2.27; 95% confidence interval, 1.19–4.34), and born‐again Protestants (adjusted odds ratio, 2.38; 95% confidence interval, 1.32–4.28). Religious minority women (adjusted odds ratio, 2.36; 95% confidence interval, 1.01–5.51) and those who reported no religion/atheist/agnostic (adjusted odds ratio, 3.16; 95% confidence interval, 1.42–7.04) were more likely to want to know a hospital’s restrictions on care. More than two thirds of women find it unacceptable for the hospital to restrict information and treatment options during miscarriage based on religion. Women who attended weekly religious services were significantly more likely to accept such restrictions (adjusted odds ratio, 3.13; 95% confidence interval, 1.70–5.76) and to consider transfer to another site an acceptable solution (adjusted odds ratio, 3.22; 95% confidence interval, 1.69–6.12). The question, “When should a religious hospital be allowed to restrict care based on religion?” was asked, and 52.3% responded never; 16.6%, always; and 31.1%,“under some conditions. Conclusion The vast majority of adult American women of reproductive age want information about a hospital’s religious restrictions on care when deciding where to go for obstetrics/gynecology care. Growth in the US Catholic health care sector suggests an increasing need for transparency about these restrictions so that women can make informed decisions and, when needed, seek alternative providers.

Training in aspiration abortion care: An observational cohort study of achieving procedural competence

BACKGROUND Studies in multiple countries have found that the provision of aspiration abortion care by trained nurses, midwives, and other front-line health care workers is safe and acceptable to women. In the United States, most state abortion laws restrict the provision of abortion to physicians; nurse practitioners, nurse-midwives, and physician assistants, can legally perform medication abortion in only twelve states and aspiration abortion in five. Expansion of abortion care by these providers, consistent with their scopes of practice, could help alleviate the increasing difficulty of accessing abortion care in many states. OBJECTIVES This study used a competency-based training model to teach advanced practice clinicians to perform vacuum aspiration for the abortion care. Previous research reporting on the training of providers other than physicians primarily focused on numbers of procedures performed, without assessment of skill competency or clinician confidence. DESIGN In this prospective, observational cohort study, advanced practice clinician trainees were recruited from 23 clinical sites across six partner organizations. Trainees participated in a standardized, competency-based didactic and clinical training program in uterine aspiration for first-trimester abortion. SETTINGS Trainee clinicians needed to be employed by one of the six partner organizations and have an intention to remain in clinical practice following training. PARTICIPANTS California-licensed advanced practice clinicians were eligible to participate in the training if they had at least 12 months of clinical experience, including at least three months of medication abortion provision, and certification in Basic Life Support. METHODS A standardized, competency-based training program consisting of both didactic and clinical training in uterine aspiration for first-trimester abortion was completed by 46 advanced practice clinician participants. Outcomes related to procedural safety and to the learning process were measured between August 2007 and December 2013, and compared to those of resident physician trainees. RESULTS Essentially identical odds of complications occurring from advanced practice clinician-performed procedures were not significantly different than the odds of complications occurring from resident-performed procedures (OR: 0.99; CI: 0.46-2.02; p > 0.05) after controlling for patient sociodemographic and medical history. The number of training days to foundational competence ranged from six to 10, and the number of procedures to competence for those who completed training ranged from 40 to 56 (median = 42.5). CONCLUSIONS A standardized, competency-based trainingprogram can prepare advanced practice clinicians to safely provide first-trimester aspiration abortions. Access to safe abortion care can be enhanced by increasing the number of providers from cadres of clinicians other than physicians.

Radical or routine? Nurse practitioners, nurse-midwives, and physician assistants as abortion providers

Abstract In 2013 California passed legislation that expanded the pool of eligible aspiration abortion providers to include advanced practice nurses, nurse-midwives, and physician-assistants. This law, enacted in 2014, is based on evidence generated by the Health Workforce Pilot Project #171, which examined the safety and effectiveness of aspiration abortion care provided by these clinicians as well as patient acceptability and satisfaction. This evidence and the resulting policy change build on international research and established workforce strategies used to expand access to safe abortion services for women worldwide, representing a radical departure from the legislative trend of constricting access in the United States. Résumé En 2013, la Californie a adopté une législation qui élargissait la liste des professions autorisées à pratiquer les avortements par aspiration pour y inclure les infirmières de pratique avancée, les infirmières sages-femmes et les assistants médicaux. Cette loi, promulguée en 2014, est fondée sur les données générées par le projet pilote n° 171 sur le personnel de santé, qui a examiné la sécurité et l’efficacité de l’avortement par aspiration assuré par ces cliniciens ainsi que l’acceptabilité de la procédure et la satisfaction des patientes. Ces données et le changement de politique en résultant se fondent sur des recherches internationales et des stratégies reconnues de gestion des personnels de santé utilisées pour élargir l’accès à des services d’avortement sûr pour les femmes dans le monde, ce qui tranche radicalement sur la tendance législative à une réduction de l’accès aux États-Unis. Resumen En el año 2013 California aprobó legislación que amplió la reserva de prestadores de servicios de aborto por aspiración elegibles, para incluir enfermeras de práctica avanzada, enfermeras-obstetras y asociados médicos. Esta ley, promulgada en el 2014, se basa en evidencia generada por el Proyecto Piloto de la Fuerza Laboral de Salud No. 171, que examinó la seguridad y eficacia de los servicios de aborto por aspiración proporcionados por estos profesionales de la salud, así como la aceptación y satisfacción por parte de las pacientes. Esta evidencia y la política resultante del cambio se basan en investigaciones internacionales y estrategias establecidas en la fuerza laboral utilizadas para ampliar el acceso a los servicios de aborto seguro para las mujeres mundialmente, lo cual representa un cambio radical en la tendencia legislativa a restringir el acceso en Estados Unidos.