Thais R M Lourenço1, Vasilis Pergialiotis2, Constantin M Durnea3,4, Abdullatif Elfituri3, Jorge M Haddad1, Cornelia Betschart5, Gabriele Falconi6, Christiana C Nygaard3,7, Lina Bergstrom8, Mittal Pattel9, Stergios K Doumouchtsis2,3,8. 1. Department of Urogynecology, Clinical Hospital of the University of São Paulo School of Medicine, São Paulo University, São Paulo, Brazil. 2. Laboratory of Experimental Surgery and Surgical Research "N.S. Christeas", Athens University Medical School, Athens, Greece. 3. Department of Obstetrics and Gynecology, Epsom and St Helier University Hospitals NHS Trust, London, UK. 4. Northwick Park Hospital, London North West University Healthcare NHS Trust, London, UK. 5. Department of Gynecology, University Hospital of Zurich, Zurich, Switzerland. 6. Department of Obstetrics and Gynecology, San Bortolo Hospital, Vicenza, Italy. 7. Department of Obstetrics and Gynecology, Hospital São Lucas, Pontifical Catholic University of Rio Grande do Sul, Rio Grande do Sul, Brazil. 8. St George's University of London, London, UK. 9. Imperial College Healthcare NHS Trust, London, UK.
Abstract
BACKGROUND: Recent systematic reviews have demonstrated wide variations on outcome measure selection and outcome reporting in trials on surgical treatments for anterior, apical and mesh prolapse surgery. A systematic review of reported outcomes and outcome measures in posterior compartment vaginal prolapse interventions is highly warranted in the process of developing core outcome sets. OBJECTIVE: To evaluate outcome and outcome measures reporting in posterior prolapse surgical trials. SEARCH STRATEGY: We searched MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL). SELECTION CRITERIA: Randomized trials evaluating the efficacy and safety of different surgical interventions for posterior compartment vaginal prolapse. DATA COLLECTION AND ANALYSIS: Two researchers independently assessed studies for inclusion, evaluated methodological quality, and extracted relevant data. Methodological quality, outcome reporting quality and publication characteristics were evaluated. MAIN RESULTS: Twenty-seven interventional and four follow-up trials were included. Seventeen studies enrolled patients with posterior compartment surgery as the sole procedure and 14 with multicompartment procedures. Eighty-three reported outcomes and 45 outcome measures were identified. The most frequently reported outcomes were blood loss (20 studies, 74%), pain (18 studies, 66%) and infection (16 studies, 59%). CONCLUSIONS: Wide variations in reported outcomes and outcome measures were found. Until a core outcome set is established, we propose an interim core outcome set that could include the three most commonly reported outcomes of the following domains: hospitalization; intraoperative, postoperative urinary, gastrointestinal, vaginal and sexual outcomes; clinical effectiveness. PROSPERO: CRD42017062456.
BACKGROUND: Recent systematic reviews have demonstrated wide variations on outcome measure selection and outcome reporting in trials on surgical treatments for anterior, apical and mesh prolapse surgery. A systematic review of reported outcomes and outcome measures in posterior compartment vaginal prolapse interventions is highly warranted in the process of developing core outcome sets. OBJECTIVE: To evaluate outcome and outcome measures reporting in posterior prolapse surgical trials. SEARCH STRATEGY: We searched MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL). SELECTION CRITERIA: Randomized trials evaluating the efficacy and safety of different surgical interventions for posterior compartment vaginal prolapse. DATA COLLECTION AND ANALYSIS: Two researchers independently assessed studies for inclusion, evaluated methodological quality, and extracted relevant data. Methodological quality, outcome reporting quality and publication characteristics were evaluated. MAIN RESULTS: Twenty-seven interventional and four follow-up trials were included. Seventeen studies enrolled patients with posterior compartment surgery as the sole procedure and 14 with multicompartment procedures. Eighty-three reported outcomes and 45 outcome measures were identified. The most frequently reported outcomes were blood loss (20 studies, 74%), pain (18 studies, 66%) and infection (16 studies, 59%). CONCLUSIONS: Wide variations in reported outcomes and outcome measures were found. Until a core outcome set is established, we propose an interim core outcome set that could include the three most commonly reported outcomes of the following domains: hospitalization; intraoperative, postoperative urinary, gastrointestinal, vaginal and sexual outcomes; clinical effectiveness. PROSPERO: CRD42017062456.
Authors: Thais Regina de Mattos Lourenço; Vasilis Pergialiotis; Constantin M Durnea; Abdullatif Elfituri; Jorge Milhem Haddad; Cornelia Betschart; Gabriele Falconi; Christiana Campani Nygaard; Stergios K Doumouchtsis Journal: Int Urogynecol J Date: 2021-04-08 Impact factor: 2.894