Diana Taylor1, Ushma D Upadhyay2, Mary Fjerstad3, Molly F Battistelli2, Tracy A Weitz2, Maureen E Paul4. 1. Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, and School of Nursing, University of California, San Francisco, 1330 Broadway, Suite 1100, Oakland, CA 94612. Electronic address: Diana.Taylor@ucsf.edu. 2. Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, Department of Obstetrics Gynecology and Reproductive Sciences, University of California, San Francisco, 1330 Broadway, Suite 1100, Oakland, CA 94612. 3. National Abortion Federation, 1090 Vermont Avenue NW #1000, Washington, DC 20005. 4. Beth Israel Deaconess Medical Center, Department of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School, 330 Brookline Avenue, Boston, MA 02215.
Abstract
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.
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.
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