Z E Winters1,2,3, M Afzal1, C Rutherford3, B Holzner4, G Rumpold5, R A da Costa Vieira6, S Hartup7, K Flitcroft8, V Bjelic-Radisic9, A Oberguggenberger4, M Panouilleres10, M Mani11, G Catanuto12, M Douek13, J Kokan14, P Sinai1, M T King3,15. 1. Breast Cancer Surgery Patient-Reported and Clinical Outcomes Research Group, University of Bristol, School of Clinical Sciences, Southmead Hospital, Bristol, UK. 2. Surgical and Interventional Trials Unit, Division of Surgical Sciences, University College London, London, UK. 3. Quality of Life Office, School of Psychology, Faculty of Science, University of Sydney, New South Wales, Australia. 4. Department of Psychiatry, Psychotherapy and Psychosomatics, Medical University of Innsbruck, Innsbruck, Austria. 5. Department of Medical Psychology, Evaluation Software Development, Rum, Austria. 6. Department of Oncology, Barretos Cancer Hospital, Sao Paolo, Brazil. 7. St James's University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK. 8. Breast and Surgical Oncology, Poche Centre, University of Sydney, New South Wales, Australia. 9. Department of Breast Surgery and Gynaecology, Medical University Graz, Graz, Austria. 10. Department of Plastic Surgery, Besançon University Hospital, Besançon, France. 11. Department of Surgical Sciences, Plastic and Reconstructive Surgery, Uppsala University, Uppsala, Sweden. 12. Multidisciplinary Breast Care, Cannizzaro Hospital, Catania, Italy. 13. Department of Surgical Oncology, Guy's Hospital, London, London, UK. 14. Cancer Resource Centre, Macclesfield Hospital, Macclesfield, UK. 15. Sydney Medical School, Faculty of Medicine, University of Sydney, New South Wales, Australia.
Abstract
BACKGROUND: The aim was to carry out phase 4 international field-testing of the European Organisation for Research and Treatment of Cancer (EORTC) breast reconstruction (BRECON) module. The primary objective was finalization of its scale structure. Secondary objectives were evaluation of its reliability, validity, responsiveness, acceptability and interpretability in patients with breast cancer undergoing mastectomy and reconstruction. METHODS: The EORTC module development guidelines were followed. Patients were recruited from 28 centres in seven countries. A prospective cohort completed the QLQ-BRECON15 before mastectomy and the QLQ-BRECON24 at 4-8 months after reconstruction. The cross-sectional cohort completed the QLQ-BRECON24 at 1-5 years after reconstruction, and repeated this 2-8 weeks later (test-retest reliability). All participants completed debriefing questionnaires. RESULTS: A total of 438 patients were recruited, 234 in the prospective cohort and 204 in the cross-sectional cohort. A total of 414 reconstructions were immediate, with a comparable number of implants (176) and donor-site flaps (166). Control groups comprised patients who underwent two-stage implant procedures (72, 75 per cent) or delayed reconstruction (24, 25 per cent). Psychometric scale validity was supported by moderate to high item-own scale and item-total correlations (over 0·5). Questionnaire validity was confirmed by good scale-to-sample targeting, and computable scale scores exceeding 50 per cent, except nipple cosmesis (over 40 per cent). In known-group comparisons, QLQ-BRECON24 scales and items differentiated between patient groups defined by clinical criteria, such as type and timing of reconstruction, postmastectomy radiotherapy and surgical complications, with moderate effect sizes. Prospectively, sexuality and surgical side-effects scales showed significant responsiveness over time (P < 0·001). Scale reliability was supported by high Cronbach's α coefficients (over 0·7) and test-retest (intraclass correlation more than 0·8). One item (finding a well fitting bra) was excluded based on high floor/ceiling effects, poor test-retest and weak correlations in factor analysis (below 0·3), thus generating the QLQ-BRECON23 questionnaire. CONCLUSION: The QLQ-BRECON23 is an internationally validated tool to be used alongside the EORTC QLQ-C30 (cancer) and QLQ-BR23 (breast cancer) questionnaires for evaluating quality of life and satisfaction after breast reconstruction.
BACKGROUND: The aim was to carry out phase 4 international field-testing of the European Organisation for Research and Treatment of Cancer (EORTC) breast reconstruction (BRECON) module. The primary objective was finalization of its scale structure. Secondary objectives were evaluation of its reliability, validity, responsiveness, acceptability and interpretability in patients with breast cancer undergoing mastectomy and reconstruction. METHODS: The EORTC module development guidelines were followed. Patients were recruited from 28 centres in seven countries. A prospective cohort completed the QLQ-BRECON15 before mastectomy and the QLQ-BRECON24 at 4-8 months after reconstruction. The cross-sectional cohort completed the QLQ-BRECON24 at 1-5 years after reconstruction, and repeated this 2-8 weeks later (test-retest reliability). All participants completed debriefing questionnaires. RESULTS: A total of 438 patients were recruited, 234 in the prospective cohort and 204 in the cross-sectional cohort. A total of 414 reconstructions were immediate, with a comparable number of implants (176) and donor-site flaps (166). Control groups comprised patients who underwent two-stage implant procedures (72, 75 per cent) or delayed reconstruction (24, 25 per cent). Psychometric scale validity was supported by moderate to high item-own scale and item-total correlations (over 0·5). Questionnaire validity was confirmed by good scale-to-sample targeting, and computable scale scores exceeding 50 per cent, except nipple cosmesis (over 40 per cent). In known-group comparisons, QLQ-BRECON24 scales and items differentiated between patient groups defined by clinical criteria, such as type and timing of reconstruction, postmastectomy radiotherapy and surgical complications, with moderate effect sizes. Prospectively, sexuality and surgical side-effects scales showed significant responsiveness over time (P < 0·001). Scale reliability was supported by high Cronbach's α coefficients (over 0·7) and test-retest (intraclass correlation more than 0·8). One item (finding a well fitting bra) was excluded based on high floor/ceiling effects, poor test-retest and weak correlations in factor analysis (below 0·3), thus generating the QLQ-BRECON23 questionnaire. CONCLUSION: The QLQ-BRECON23 is an internationally validated tool to be used alongside the EORTC QLQ-C30 (cancer) and QLQ-BR23 (breast cancer) questionnaires for evaluating quality of life and satisfaction after breast reconstruction.
Authors: Elles M F van de Voort; Taco M A L Klem; Gerson M Struik; Erwin Birnie; Renata H J A Sinke; Ali Ghandi Journal: Br J Radiol Date: 2020-07-20 Impact factor: 3.039
Authors: Ankur Khajuria; Max Prokopenko; Max Greenfield; Oliver Smith; Andrea L Pusic; Afshin Mosahebi Journal: Plast Reconstr Surg Glob Open Date: 2019-10-28
Authors: Soo-Kyung Bok; Youngshin Song; Ancho Lim; Hyunsuk Choi; Hyunkyung Shin; Sohyun Jin Journal: Int J Environ Res Public Health Date: 2020-12-08 Impact factor: 3.390
Authors: Walter P Weber; Martin Haug; Christian Kurzeder; Vesna Bjelic-Radisic; Rupert Koller; Roland Reitsamer; Florian Fitzal; Jorge Biazus; Fabricio Brenelli; Cicero Urban; Régis Resende Paulinelli; Jens-Uwe Blohmer; Jörg Heil; Jürgen Hoffmann; Zoltan Matrai; Giuseppe Catanuto; Viviana Galimberti; Oreste Gentilini; Mitchel Barry; Tal Hadar; Tanir M Allweis; Oded Olsha; Maria João Cardoso; Pedro F Gouveia; Isabel T Rubio; Jana de Boniface; Tor Svensjö; Susanne Bucher; Peter Dubsky; Jian Farhadi; Mathias K Fehr; Ilario Fulco; Ursula Ganz-Blättler; Andreas Günthert; Yves Harder; Nik Hauser; Elisabeth A Kappos; Michael Knauer; Julia Landin; Robert Mechera; Francesco Meani; Giacomo Montagna; Mathilde Ritter; Ramon Saccilotto; Fabienne D Schwab; Daniel Steffens; Christoph Tausch; Jasmin Zeindler; Savas D Soysal; Visnu Lohsiriwat; Tibor Kovacs; Anne Tansley; Lynda Wyld; Laszlo Romics; Mahmoud El-Tamer; Andrea L Pusic; Virgilio Sacchini; Michael Gnant Journal: Breast Cancer Res Treat Date: 2018-09-04 Impact factor: 4.872