Download This Paper
Preprints with The Lancet is a collaboration between The Lancet Group of journals and SSRN to facilitate the open sharing of preprints for early engagement, community comment, and collaboration. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early-stage research papers that have not been peer-reviewed. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. The findings should not be used for clinical or public health decision-making or presented without highlighting these facts. For more information, please see the FAQs.
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
32 Pages Posted: 13 Jun 2019
More...Abstract
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: The 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. The 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: The study was funded by a grant from the Programme de Recherche sur la Performance du système des Soins - PREPS 2012 (Ministère de la Santé, 12-002-0081 Prof. Fauconnier). The sponsor was Assistance Publique - Hôpitaux de Paris (Shoreh Azimi, Département de la Recherche Clinique et du Développement). The URGO Study was also supported by Versailles-Saint399 Quentin University and its Institut de Recherche en Santé de la Femme (IRSF).
Declaration of Interests: The 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. The Ethics Committee of Ile-de-France, VII approved the study.
Suggested Citation: Suggested Citation