RESUMEN
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.
Asunto(s)
Indicadores de Salud , Mamoplastia , Calidad de Vida , Adulto , Anciano , Estudios Transversales , Europa (Continente) , Femenino , Humanos , Mastectomía , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Satisfacción del Paciente , Estudios Prospectivos , Psicometría , Reproducibilidad de los ResultadosRESUMEN
A 52-year-old lady was seen in the breast clinic after an 8 mm lesion was found in her left breast on screening mammogram. Clinical examination was normal. The left breast mammogram showed an 8 mm rounded density posteriorly in the inner half of breast and ultrasound also showed a 7 mm, well-defined ovoid echogenic lesion (R3, U3). Biopsy confirmed the lesion was fibro-fatty tissue containing a diffuse infiltrate of lymphoid cells macroscopically (B3/4)-findings in line with a diagnosis of a myofibroblastoma. A myofibroblastoma is a rare benign mesenchymal tumour comprising of spindle cells. Most breast myofibroblastomas described in the literature have been excised by wide local excision. In this patient's case, a vacuum-assisted technique was discussed and suggested at the multidisciplinary meeting. It was excised using ultrasound-guided Vacora® breast biopsy system. The lesion was completely excised with the encore biopsy measuring 24 × 17 mm. This is the first documented case of such a technique for the excision of a breast myofibroblastoma. There still is uncertainty about breast myofibroblastomas, their aetiology, associations, and how they are best investigated. Regarding management, vacuum-assisted technique, being less invasive and cheaper than local excisions, is adequate for small lesions.