Patients help decide on study endpoints
In the first prospective study of theOncoplastic Breast Consortium (OPBC), patient representatives clearly prioritised the measurement of quality of life as the primary andpoint. To them, this aspect of implant-based breast reconstruction after mastectomy was most important.
The OPBC-02 PREPEC study is looking at breast reconstruction using implants after mastectomy. However, it is currently unknown whether positioning the implant anterior (prepectoral) or posterior (subpectoral) to the pectoral muscle is better for patients.
Patient representatives from the OPBC were instrumental in developing the study design and selecting the study endpoints. The fact that this study is primarily focused on measuring quality of life is due to their influence. In addition, the study evaluates safety, satisfaction, aesthetics and distress for patients in the two comparison groups.
Prof. Walter P. Weber, study director and founder of the OPBC, an international body for the continuous improvement of oncoplastic breast surgery, summarises his experience of working with patient representatives in the planning of new studies as follows: "I have learned that patient representatives have high expectations of the treating physicians and want only the best for themselves and their colleagues. They are highly motivated and committed."
Walter P. Weber formulates his recommendations for involving patients in the planning and development of new studies as follows: "First, it is important to seek the opinion of patients as early as possible. When it comes to a specific study, the most important question is whether the endpoint is relevant from the patient's perspective. Secondly, one should discuss the feasibility of the study, because in the end a study will only be successful if the effort of participation is acceptable. The recruitment rate and drop-out rate depend on this. Patients must be able to stand by the study."
PRE- versus sub-PECtoral implant-based breast reconstruction after skin- and nipple-sparing mastectomy: A pragmatic, multicenter, randomized, superiority trial
Prof. Walter P. Weber, Elisabeth A. Kappos, University Hospital Basel
Prof. Yves harder, Ospedale Regionale di Lugano
9 breast centers in Switzerland and 16 centers in Europe, the USA and South America
Number of planned patients
Follow-up until 2032
Prioritisation of study endpoints, choice of study design
Methodological Consulting, Regulatory Affairs, Project Management, Data Management, Monitoring, PPI Consulting
SNF IICT, Cancer Research Switzerland, Krebsliga beider Basel
"Our patient representatives are an absolute added value because they ensure that we focus on the really relevant issues. What unites us is the fight against the disease and for optimal patient care."
Prof. Walter P. Weber, Medical Department Head, Chief of Breast Surgery, University Hospital Basel, Founder of the Oncoplastic Breast Consortium (OPBC).