Protocol for the development of a core outcome set for autologous fat grafting to the breast.

INTRODUCTION: One in eight women will develop breast cancer in their lifetime. Reconstruction is routinely offered to patients and can be autologous and/or implant based. One area of growing interest in autologous fat grafting (AFG). Our group recently published a systematic review and meta-analysis of this topic which showed 51 different outcomes were being utilized in the published literature, with substantial heterogeneity in their definitions.

METHODS AND ANALYSIS: A Delphi consensus exercise amongst key stakeholders will be conducted using the long list of 51 outcomes generated through our previous work. We will first group these according to the six domains previously identified; oncological, clinical, aesthetic and functional, patient-reported, process and radiological. Through sequential rounds of voting, the long list of outcomes will be narrowed down using predefined rules of agreement.

ETHICS AND DISSEMINATION: No patients will be involved in this study and ethical approval is not required. The research will be published in a peer-reviewed journal. It will also be presented at national and international conferences in the fields of plastic, reconstructive and aesthetic surgery as well as breast surgery and at more general surgical and methodological conferences. It will be disseminated electronically and in print. Brief reports of the review findings will be disseminated directly to the appropriate audiences of surgeons and societies through email and other modes of communication.