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.

Lessons learned

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."

Tips

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."