School of Clinical Sciences and Breast Reconstruction Patient Reported and Clinical Outcomes Research Group, School of Clinical Sciences, University of Bristol and North Bristol NHS Trust, Southmead Hospital, Bristol, Departments of.
Br J Surg. 2014 Mar;101(4):371-82. doi: 10.1002/bjs.9397. Epub 2014 Jan 29.
Comprehensive outcome assessments after breast reconstruction (BRR) require surgery-specific patient-reported outcome measures. The aims of this study were to assess the relevance, acceptability and redundancy of questions/items (phase III pretesting) of a new BRR questionnaire evaluating patients' health-related quality of life before and after BRR. Phase III occurred in collaboration with the European Organization for Research and Treatment of Cancer (EORTC) following earlier development phases that identified 31 items.
The EORTC BRR subgroup applied decision-making rules to each question according to eight EORTC criteria. A total of 197 patients (from the UK, Austria, Belgium, Italy and Sweden) were recruited. Forty-seven patients completed pre- and post-BRR questionnaires prospectively, and 150 reported post-BRR questionnaires only retrospectively. Qualitative debriefing interviews were undertaken in 189 patients. Preliminary psychometric analyses were performed.
Thirty-one items fulfilled 'relevance', with none producing 'difficulties'. Ten items were not a priority for 10 per cent of respondents. Of these, two questions concerning muscle twitching in the affected breast and problem with donor-site swelling were deleted. Three redundant items were deleted: weakness in arm, which correlated significantly to the Quality of Life Questionnaire (QLQ) BR23 breast questionnaire, and shape and colour of the affected nipple. Descriptive statistics reduced the module to 26 items conceptualized into three provisional scales (disease treatment/surgery-related symptoms, sexuality and cosmetic outcome) within the newly completed questionnaire, EORTC QLQ-BRR26.
The QLQ-BRR26 is available for psychometric validation in a large-field international sample. The intended use for QLQ-BRR26 is alongside EORTC QLQ-C30 and QLQ-BR23, in women treated by mastectomy for breast cancer and undergoing all types of BRR.
乳房重建（BRR）后的综合结果评估需要特定于手术的患者报告结果测量。本研究的目的是评估一种新的 BRR 问卷评估 BRR 前后患者健康相关生活质量的问题/项目的相关性、可接受性和冗余性（第三阶段预测试）。第三阶段是在 EORTC 早期开发阶段之后进行的，该阶段确定了 31 个项目。
EORTC BRR 小组根据 EORTC 的八项标准，对每个问题应用决策规则。共有 197 名患者（来自英国、奥地利、比利时、意大利和瑞典）入组。47 名患者前瞻性地完成了 BRR 前后问卷，150 名患者仅回顾性地报告了 BRR 后问卷。对 189 名患者进行了定性深入访谈。进行了初步心理测量分析。
31 个项目符合“相关性”，没有一个项目产生“困难”。有 10 个项目对 10%的受访者不是优先事项。其中，两个关于受影响乳房肌肉抽搐和供体部位肿胀问题的问题被删除。删除了三个冗余项目：手臂无力，与生活质量问卷（QLQ）BR23 乳房问卷显著相关，以及受影响乳头的形状和颜色。描述性统计将该模块减少到 26 个项目，这些项目在新完成的问卷 EORTC QLQ-BRR26 中概念化为三个暂定量表（疾病治疗/手术相关症状、性和美容结果）。
QLQ-BRR26 可用于大样本国际样本的心理测量验证。QLQ-BRR26 的预期用途是与 EORTC QLQ-C30 和 QLQ-BR23 一起使用，用于接受乳腺癌乳房切除术治疗并接受所有类型 BRR 的女性。
