Potentially Life-Threatening Emergencies and Near-Misses as a Framework for Quality and Safety Measurement in Gynaecological Emergency Care: Results of the URGO Multicentre Prospective Study

Several acute gynaecological (including pelvic or early pregnancy-related) conditions may be responsible for severe complications or death. Accordingly, a precise list of these conditions might be provide relevant outcomes for measuring processes and their relation to diagnostic errors in gynaecological emergencies. Methods: This multicentre study including 21 gynaecological emergency departments (G-EDs) in France and Belgium began with a modified Delphi procedure (in 2014) among health-care providers to define relevant combinations of gynaecological potentially life-threatening emergencies (G-PLEs) and near-misses. A prospective case-cohort study (March 9-April 13, 2015) then assessed their relative frequencies and analysed the risks among women of reproductive age with acute pelvic pain (APP) consulting at these G-EDs. Findings: Delphi procedure identified eight G-PLEs, defined as painful conditions at high risk of rapid deterioration and potentially threatening to life or fertility, and 17 near-miss criteria (adapted from similar obstetric standards). Among the 3825 women with APP, 130 (3*5%, 95% CI [3*0-4*1]) were diagnosed with a G-PLE. most common G-PLEs were complicated ectopic pregnancies with severe bleeding, complicated pelvic inflammatory disease, adnexal torsion, haemorrhagic miscarriage, and complicated appendicitis. Controls were the 225 women hospitalised for a non-G-PLE condition and a random sample of 381 outpatients. Diagnostic errors occurred more frequently among women with G-PLEs than among controls. Of the women with G-PLEs, 26 (20*6%) met near-miss criteria, compared with 6 with non-G-PLE conditions (1*6%), OR 25*6 (95% CI [10*9-70*7]). Interpretation: G-PLEs are a group of frequently encountered and serious conditions that may present diagnostic challenges in women consulting for APP at G-EDs. Routine tracking of G-PLEs and near-miss is feasible and may serve as a useful framework for research and actions to improve quality of care in this setting. Funding Statement: study was funded by a grant from the Programme de Recherche sur la Performance du systeme des Soins - PREPS 2012 (Ministere de la Sante, 12-002-0081 Prof. Fauconnier). sponsor was Assistance Publique - Hopitaux de Paris (Shoreh Azimi, Departement de la Recherche Clinique et du Developpement). URGO Study was also supported by Versailles-Saint399 Quentin University and its Institut de Recherche en Sante de la Femme (IRSF). Declaration of Interests: authors declare: The authors did not report any disclosure of interest for the present study. Ethics Approval Statement: No written informed consent was required by French law for this observational, non-interventional study 242 (Huriet-Serusclat law, 20 December 1998). However, all women received information about it study and 243 could decline to participate. Ethics Committee of Ile-de-France, VII approved the study.