On August 20, 2020, the U.S. Food and Drug Administration (FDA) announced the qualification of the BREAST-Q Reconstruction Module for breast reconstruction studies through the agency’s Medical Device Development Tool (MDDT) Program. Qualification of the BREAST-Q Reconstruction Module MDDT included the Physical Well-being (Chest), Psychosocial Well-being, Sexual Well-being, and Satisfaction with Breasts scales. More information can be found in this article from the Regulatory Affairs Professionals Society: https://www.raps.org/news-and-articles/news-articles/2020/8/fda-qualifies-decision-tool-for-breast-reconstruct. The FDA announcement can be read here: https://www.fda.gov/news-events/press-announcements/fda-updates-analysis-medical-device-reports-breast-implant-illness-and-breast-implant-associated
Manraj Kaur, PhD candidate supervised by Anne Klassen at McMaster University, won the Student Poster Presentation Award at the 26th Annual International Society for Quality of Life Research (ISOQOL) Conference in California, USA. Manraj presented her research on “Examining content validity of BREAST-Q a decade later to determine relevance and comprehensiveness”. Congratulations Manraj!!!
Anne Klassen and her team were featured in a Plastic Surgery News Magazine (PSN) article highlighting their research funded by the National Endowment for Plastic Surgery (NEPS) Grant through the Plastic Surgery Foundation. The article includes updates on the research project and can be read here: PSN Article on NEPS Grant
Anne Klassen and her team of Program Experts in Canada, USA, Denmark and the Netherlands are thrilled to receive a 7-year CIHR Foundation Grant entitled: “Measuring Outcomes and Experiences of Gender-Affirming Healthcare”. Funding will be used to finish the development of the GENDER-Q and to advance a program of transgender health research. The Foundation Award covers the following flexible multi-phased program of research:
- Phase 1: International qualitative study to develop the GENDER-Q;
- Phase 2: International field-test to refine the scales and develop scoring algorithms;
- Phase 3: Research to measure change for a range of gender-affirming treatments; and
- Phase 4: Research to evaluate the use of the GENDER-Q in clinical practice.
Anne Klassen is recipient of the 2018 Bernard G. Sarnat Excellence in Grant Writing Clinical Research award for her top ranked PSF grant application entitled: “Developing the GENDER-Q to Measure Outcomes for Gender-Affirming Treatment. This grant funds a qualitative study of teens and adults who are seeking or have had any form of gender-affirming treatment.
Q-Portfolio is thrilled to be a FINALIST in the 2019 Safety in Beauty Diamond Awards. These awards, founded 5 years ago by Antonia Mariconda, are given to individuals and groups helping to advance the highest standards of safety in the beauty and aesthetics industry.
Listen to an 11-minute interview with Andrea Pusic where she discusses the Q-Portfolio
Follow the links below to see examples of FDA Label Claims that include the FACE-Q :