Abstract P2-19-08: Phase III development of the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) module for women undergoing breast reconstruction: The EORTC QLQ-BRR26
Authors: Winters ZE , Balta V , Thomson HJ , Llewellyn-Bennett R , Oberguggenberger A , Sinove Y , Nava M , Bruno N , Sandelin K , Unukovych D , Blondeel P , Brandberg Y , Johansson H 
Published: August 2014

Abstract
Introduction: Comprehensive outcome assessments after breast reconstruction (BRR) require surgery- specific Patient Reported Outcomes Measures (PROMS). Completion of early Phases I-II development resulted in a 31-item questionnaire comprising 5 hypothesised scales and (numbers of items) : Treatment /surgery related symptoms (4), body image (3), sexuality (4), cosmetic outcomes (breast, n = 7, donor site, n = 5, nipple, n = 6) and overall satisfaction (2). Current evidence shows no BRR-specific PROM, with the further validation of the BREAST-Q, currently the only PROM. The aim of this study was Phase III pre-testing of a BRR questionnaire assessing patients’ health related quality of life (HRQL) before and after BRR, in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC). Pre-testing assessed the relevance, acceptability and redundancy of questions in all types of BRRs. This PROM is intended for use alongside the EORTC QLQ-C30, and QLQ-BR23 in women treated for breast cancer before and after mastectomy and all BRR types.
Methods: The EORTC BRR HRQL subgroup applied decision-making rules to each question according to eight EORTC criteria comprising 1. priority, 2. relevance and 3. difficulty /consistency across five European languages and cultures. Descriptive statistics used HRQL score criteria: 4. mean &gt;1.5, 5. range &gt;2, 6. floor and ceiling effects &gt;10%, 7. prevalence ratios &gt;30% and 8. compliance &gt;95%.
197 patients (UK, Austria, Belgium, Italy, Sweden) were recruited: 47 prospectively completing pre- and post-BRR questionnaires, and 150 retrospectively reporting only post-BRR questionnaires. 189 patients underwent qualitative debriefing interviews. Preliminary psychometric analyses performed multi-trait scaling using EORTC QLQ-C30 and QLQ- BR23 that were used in final decisions on items and scales.
Results: 31 questions /items fulfilled ‘relevance’, with none producing ‘difficulties’. Ten items were not a ‘priority’ in 10% of respondents. Of these, two questions comprising ‘muscle twitching in affected breast’ and ‘problem with donor site swelling’ were deleted, fulfilling less than 5 out of 8 criteria. Deletions of three redundant items comprised ‘weak arm’, which correlated significantly to QLQ-BR23; and ‘shape’ and ‘colour’ of affected nipple with similarities to ‘overall nipple appearance’. Descriptive statistics and clinical judgment reduced the module to 26 items conceptualized into three scales (and items): Disease Treatment /Surgery related symptoms (2), Sexuality (5), and Cosmetic outcomes (breast, n = 10, donor site, n = 4, nipple, n = 4) within the EORTC QLQ-BRR26. The body image and overall satisfaction scales were dropped, with their respective items incorporated into other scales.
Discussion: The QLQ-BRR26 has completed phase III development and is available for psychometric validation in a large field international sample that aims to recruit 450 patients across 17 European centres. Psychometric testing will be finalised in Phase IV including the evaluation of the questionnaires’ responsiveness to the effects of BRR subgroups with comparisons to the BREAST-Q.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P2-19-08.