Stergios K Doumouchtsis1,2,3,4,5, Jemina Loganathan6, John Fahmy2, Gabriele Falconi7, Maria Rada8, Abdullatif Elfituri1, Jorge Milhem Haddad9, Vasilios Pergialiotis10, Cornelia Betschart11. 1. Department of Obstetrics and Gynaecology, Epsom and St Helier University Hospitals NHS Trust, Dorking Road, London, UK. 2. St George's University of London, London, UK. 3. Laboratory of Experimental Surgery and Surgical Research "N.S. Christeas", National and Kapodistrian University of Athens, Medical School, Athens, Greece. 4. School of Medicine, American University of the Caribbean, Cupecoy, Sint Maarten. 5. School of Medicine, Ross University, Miramar, Florida, United States. 6. Department of Obstetrics and Gynaecology, Epsom and St Helier University Hospitals NHS Trust, Dorking Road, London, UK. jemina.loganathan@nhs.net. 7. Department of Obstetrics and Gynaecology, San Bortolo Hospital, Vicenza, Italy. 8. 2nd Department of Obstetrics and Gynaecology, "Iuliu Hatieganu", University of Medicine and Pharmacy, Cluj-Napoca, Romania. 9. Department of Obstetrics and Gynecology, School of Medicine, University of São Paulo, Butanta, Brazil. 10. First Department of Obstetrics and Gynecology, Alexandra Hospital, Athens University Medical School, Athens, Greece. 11. Department of Gynecology, University Hospital of Zurich, Frauenklinikstrasse 10, 8091, Zurich, Switzerland.
Abstract
INTRODUCTION AND HYPOTHESIS: In evaluating the effectiveness of interventions in perineal trauma research, outcomes reported by patients should have a prominent focus. There is no international consensus regarding the use of either patient-reported outcomes (PROs) or tools used to determine these outcomes (patient-reported outcome measures, PROMs). The objective was to evaluate the selection, reporting and geographical variations of PROs and PROMs in randomised controlled trials (RCTs) on perineal trauma. METHODS: We performed a systematic review of RCTs in perineal trauma research evaluating outcome and outcome measure reporting. We identified PROs and PROMs and grouped PROs into domains and themes, a classification system based on a medical outcome taxonomy. RESULTS: Of 48 included RCTs, 47 reported PROs. In total, we identified 51 PROs. Outcome reporting consistency was low, with 27 PROs reported only once. Nine PROs were reported more than five times, the most frequent being perineal pain, with no geographical variation in reporting. Four themes encompassing 12 domains were identified. The most frequently reported theme was "Clinical", with 25 PROs grouped within four domains. "Resource use" and "Adverse events" themes were rarely reported, with only five PROs. PROMs also exhibited variation. Most common were visual analogue scale (VAS; 100 mm), Cleveland Clinic Continence Score, The Faecal Incontinence Quality of Life scale, VAS (0-10) and the McGill Pain Questionnaire. CONCLUSIONS: Significant heterogeneity in PROs and PROMs was observed among RCTs. Despite inconsistency, PROs are the most prevalent outcome in perineal trauma research. Patient-reported adverse events are underreported. Their use in determining the effectiveness and safety of interventions makes their integration important in perineal trauma core outcome sets. Identification and grouping of outcomes will assist future core outcome consensus studies.
INTRODUCTION AND HYPOTHESIS: In evaluating the effectiveness of interventions in perineal trauma research, outcomes reported by patients should have a prominent focus. There is no international consensus regarding the use of either patient-reported outcomes (PROs) or tools used to determine these outcomes (patient-reported outcome measures, PROMs). The objective was to evaluate the selection, reporting and geographical variations of PROs and PROMs in randomised controlled trials (RCTs) on perineal trauma. METHODS: We performed a systematic review of RCTs in perineal trauma research evaluating outcome and outcome measure reporting. We identified PROs and PROMs and grouped PROs into domains and themes, a classification system based on a medical outcome taxonomy. RESULTS: Of 48 included RCTs, 47 reported PROs. In total, we identified 51 PROs. Outcome reporting consistency was low, with 27 PROs reported only once. Nine PROs were reported more than five times, the most frequent being perineal pain, with no geographical variation in reporting. Four themes encompassing 12 domains were identified. The most frequently reported theme was "Clinical", with 25 PROs grouped within four domains. "Resource use" and "Adverse events" themes were rarely reported, with only five PROs. PROMs also exhibited variation. Most common were visual analogue scale (VAS; 100 mm), Cleveland Clinic Continence Score, The Faecal Incontinence Quality of Life scale, VAS (0-10) and the McGill Pain Questionnaire. CONCLUSIONS: Significant heterogeneity in PROs and PROMs was observed among RCTs. Despite inconsistency, PROs are the most prevalent outcome in perineal trauma research. Patient-reported adverse events are underreported. Their use in determining the effectiveness and safety of interventions makes their integration important in perineal trauma core outcome sets. Identification and grouping of outcomes will assist future core outcome consensus studies.
Authors: Susan H Oakley; Vivian C Ghodsi; Catrina C Crisp; Maria Victoria Estanol; Lauren B Westermann; Kathleen M Novicki; Steven D Kleeman; Rachel N Pauls Journal: Female Pelvic Med Reconstr Surg Date: 2016 Jul-Aug Impact factor: 2.091
Authors: Ruwan J Fernando; Abdul H Sultan; Christine Kettle; Simon Radley; Peter Jones; P M S O'Brien Journal: Obstet Gynecol Date: 2006-06 Impact factor: 7.661