BREAST-Q | BREAST CANCER

CONCEPT-DRIVEN APPROACH

The BREAST-Q is a rigorously developed patient-reported outcome measure for use in cosmetic and reconstructive breast surgery and clinical practice. The BREAST-Q was developed from concept elicitation interviews with 48 women having different forms of breast surgery (augmentation, reduction, and reconstruction). To establish content validity, we conducted focus groups and pilot testing with 58 women, and final cognitive debriefing interviews with 30 women. We also obtained input from clinical experts. The BREAST-Q was then field-tested in a sample of 1950 women (1085 reconstruction). A further psychometric validation study was performed in an independent sample of 817 women (358 reconstruction). Since its publication in 2009, the BREAST-Q has been licensed for use by more than 4000 clinicians and researchers in >75 countries.

MODULAR DESIGN

The BREAST-Q conceptual framework covers 2 domains: quality of life, and patient satisfaction. We developed independent modules for breast cancer (mastectomy, breast-conserving therapy, reconstruction), augmentation, and reduction/mastopexy. Each module is composed of multiple independently functioning scales. The variety of scales provides flexibility to choose the subset of scales best suited to measure the outcomes of interest in any given study or clinical situation. The modular structure, with individually scored scales, offers an advantage of adding new scales to fill any gap as these are identified. To this end, our team recently performed 58 new concept elicitation interviews with women with breast cancer, and developed new scales for the reconstruction module, and utility module for use in health economic studies. We are also developing a breast implant illness module.

Advancing Knowledge &
Improving Health Outcomes

Research

Publications involving 1000s of women from numerous countries.

Industry

Qualified by USA FDA as Medical Device Development Tool (MDDT) for use in research studies.

Benchmarking

Included in ICHOM Breast Cancer Standard Set to enable hospitals around the world to compare outcomes.

Patient Care

Built into electronic health records in multiple hospitals around the world.

SCALE STRUCTURE

The BREAST-Q module for women who undergo treatment for breast cancer includes multiple independently functioning scales that measure expectations, outcomes, and experience of health care from the patient perspective. New scales recently developed measure breast sensation, animation deformity, cancer worry, fatigue and impact on work. Clinicians and researchers are able to administer the subset of scales relevant to their situation.

In August 2020, the US Food and Drug Administration qualified the BREAST-Q Reconstruction Module as a medical device development tool (MDDT) to aid in the assessment of certain medical devices (eg, breast implants). More specifically, 4 scales from the BREAST-Q Reconstruction Module were qualified: Satisfaction with Breasts, Physical Well-being (Chest), Psychosocial Well-being, Sexual Well-being.

EXPECTATIONS

Given before surgery, this set of scales measures the expectations of the patient in terms of the process and outcome of surgery.

PSYCHOSOCIAL WELL-BEING

Measures psychosocial well-being with items that ask about body image and a woman’s confidence in social settings.

PHYSICAL WELL-BEING

Measures pain or tightness and difficulty with mobility, such as lifting arms.

SEXUAL WELL-BEING

Asks about feelings of sexual attractiveness, sexual confidence, and comfort level during sex.

SATISFACTION WITH BREASTS

Items cover breast size, how bras fit, and appearance in the mirror clothed or unclothed, as well as how the breasts feel to the touch.

EXPERIENCE OF CARE

These scales measure satisfaction with information and with members of the healthcare team, i.e., surgeon, radiation oncologist, medical team, and office staff.

BREAST CANCER FRAMEWORK

CO-DEVELOPERS

Dr Anne Klassen

McMaster University, CA

Dr Andrea Pusic

Brigham and Women’s Hospital, US

Dr Stefan Cano

Modus Outcomes, UK