The BODY-Q: Eating Module initiative aims to validate new scales for a patient-reported outcome measure (PROM) for bariatric surgery and medical weight loss patients. This Rasch measurement theory-based PROM assesses quality of life, eating habits/feelings, appearance and patient experience with care. Additionally, the PROMs data collected will be paired with clinical data from the electronic health record (EHR) system to generate a bariatric surgery database. This database will inform multiple bariatric surgery-related research programs to improve bariatric surgery care.

Lead Investigators             Danny Mou, MD                     email: dmou2@partners.org

                                              Claire DeVries, MD                 email: cdevries@bwh.harvard.edu

The BREAST-Q© was published in 2009 and is the gold standard PROM for breast cancer surgery. The BREAST-Q© contains 3 Breast Cancer modules (i.e., Mastectomy, Breast-conserving therapy, and Reconstruction) with a range of independently functioning scales that measure aspects of health-related quality of life and satisfaction. As part of a new research effort to fill perceived “gaps” in the set of scales that currently form the BREAST-Q©, our team set out to develop new scales that measure aspects of breast cancer and surgical recovery as well as scales that address the following topics:

Breast Sensation: a persistent challenge to the reconstructive surgeon has been addressing the loss of breast sensation post-mastectomy. With sensory restoration post-breast reconstruction now becoming an important focus of the reconstructive goals, the need for scales that can measure return of sensation is paramount.

Breast Animation Deformity: a complication of sub-pectoral implant placement whereby the breast implant moves upon flexing of the chest muscles. Movement of the implant can range in severity from very minor to an obvious major deformity that can have a huge impact on patient health-related quality of life.

Lymphedema: a complication of axillary lymph node dissection referring to the fibro-adipose deposition and swelling of tissue as a result of having a chronic accumulation of interstitial fluid. Individuals with lymphedema experience persistent pain, decreased function, body image disturbance, and anxiety, resulting in a considerable decline in physical, psychological, and social well-being.

Lead investigator             Elena Tsangaris, Ph.D             email: etsangaris@bwh.harvard.edu

Wounds represent an important health problem and challenge to patients, healthcare professionals, and healthcare systems alike. Wounds vary greatly in terms of their impact on patients’ in terms of recovery and return to usual activities and health-related quality of life (HRQoL). Our team is developing a new PROM to measure outcomes of chronic wounds.

Lead Investigator             Elena Tsangaris, Ph.D      email: etsangaris@bwh.harvard.edu

Migraine headache (MH) is a debilitating disease that leads to significant functional morbidity and poor of health-related quality of life. Traditional therapies for MH include preventative and abortive medications, injectables, and medical devices. More recently, surgery for MH has become available to select candidates who have failed conservative treatment. A standardized tool to report outcomes and improve research efforts in migraine treatment is not available. Our team is developing a new PROM to measure outcomes of migraine treatment.

Lead Investigators           Lisa Gfrerer, MD                                email: lgfrerer@partners.org

                                             Elena Tsangaris, Ph.D                      email: etsangaris@bwh.harvard.edu

Face and upper limb vascularized composite tissue transplantation (VCA) seek to restore function, psychological wellbeing, and social participation for patients who have experienced devastating injuries. Despite good survival outcomes, the lack of suitable PROMs means that the impact of face and upper-extremity VCA and their associated immunotherapies on patients remains unknown. Our team is developing new condition-specific PROMs to assess issues which matter the most to patients and candidates for VCA transplantation.

Lead Investigator             Elena Tsangaris, Ph.D             email: etsangaris@bwh.harvard.edu