Assessing the clinical effectiveness of breast reconstruction through patient-reported outcome measures.

Breast cancer remains the most common malignancy in women worldwide. Early detection and treatment means that over 70 per cent survive for more than 10 years, with approximately 60 per cent of women predicted to be alive 20 years following their initial diagnosis1. There is an increasing focus on the issues of ‘survivorship’ and the impact of surgical and other treatments on patients’ health-related quality of life (HRQoL). Although the growing practice of oncoplastic breast surgery has increased the use of breast conservation therapy for stage I and II disease, about a third of the 44 000 women diagnosed annually with breast cancer in the UK have mastectomy recommended or choose it as their preferred option1,2. In assessing clinical effectiveness, evidence of the importance of considering not only patient morbidity and mortality, but also patient perceptions of the results of surgery is increasing3. The growth of research into patient-reported outcome measures (PROMs) is based on the main goal of breast reconstruction to satisfy the patient with respect to psychosocial sequelae, physical function and perception of the aesthetic result3. PROMs are questionnaires that quantify HRQoL and/or other significant outcome variables, such as patient satisfaction3. The US Food and Drug Administration has defined PROMs as a ‘measurement of any aspect of a patient’s health status that comes directly from the patient’3. PROMs should assess the impact of disease, treatment and surgical intervention on various aspects of outcome. They should be clinically meaningful, scientifically sound and practical3,4. PROMs may differ significantly from those recorded by a clinical evaluator, and are important complementary assessments of clinical effectiveness. HRQoL measurement covers the impact of breast cancer and its treatment on some aspect of physical or psychological well-being or function, for example physical, role, cognitive or social5. There is a an underlying belief that mastectomy has important consequences on a patient’s quality of life, including psychosocial, physical, aesthetic, body image and sexual effects6. The evidence for this, however, remains equivocal, based on a systematic review of HRQoL outcomes in all types of immediate and delayed breast reconstructions from 1978 to 20097. Thirty-four studies were included and evaluated according to the Efficace criteria, which define a minimum standard checklist for quality of methodological reporting of HRQoL8. The quality of the evidence was still generally poor with only 13 level I (n = 2) and level II (n = 11) studies. Although some used breast cancerspecific instruments that have been validated in line with internationally accepted criteria for assessing HRQoL, including the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B), the European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23) and the Body Image Scale, none has been specifically validated inwomen undergoing breast reconstruction7. They may prove valid and reliable, but have not been designed specifically to reflect changes resulting from breast reconstruction4. A systematic review to identify PROMs developed and validated for use in cosmetic and reconstructive breast surgery revealed that only seven of 227 PROMsmeasuring satisfaction and/or breast-related quality of life had undergone development and validation in a cosmetic or reconstructive breast surgery population4. Of these, only two were applicable to breast reconstruction, both related to the Michigan Breast ReconstructionOutcomes Study (MBROS). One examined patient satisfaction (MBROS-S) and the other body image (MBROSI)4. Neither questionnaire, however, was developed in keeping with current internationally accepted criteria, nor did they specifically address key issues relating to either the donor site, nipple reconstruction or the reconstructed breast. As they were developed exclusively in the context of expander/implant or transverse rectus abdominis myocutaneous flap reconstruction, neither has been validated across the spectrum of breast reconstructive procedures such as preservation of the skin envelope and/or nipple-sparing mastectomy with a variety of immediate breast reconstructionmethods, and delayed methods that relate to the use of implantonly, implant-assisted tissue flaps or