Patient Reported Outcome Measures (PROMs) in breast reconstruction: a prospective cohort study.

One may wonder whether a breast reconstruction after mastectomy is a medically
necessary procedure. In a non-medical necessary intervention, the effectiveness
of the treatment may be difficult to determine. Because ther is limited
evidence for the effectiveness of treatment, there is a risk of suboptimal
care, unnecessary costs and patient will have risk of complications due to
unnecessary surgeries. Patient reported outcome measures are a instrument to
measure whether the procedure will benefit the patient. The patient is asked to
answer a questionnaire, the Breast-Q questionaire will be used in this study.
The Breast-Q questionnaire is divided into 2 domains: quality of life and
satisfaction. Usinn this questionnaire will help us to answer the question:
What is the effectiveness of breast reconstruction (quality of life and
satisfaction) from the perspective of the patient?

The aim of this study is to determine the effectiveness of the treatment
(breast reconstruction) from the perspective of the patient's. By examining the
results, the impact on the well-being and satisfaction, we will be able to
customize the reconstruction to the needs of the woman and provide het with the
best possible guidance, treatment and care.

Prospective cohort study.

The participant may not experience any personal benefit of the study, as it
will take time before conclusions can be drawn from the collected data. The
expectation is that if the objectives of the study have been achevied, the
department will be able to optimize the treatment, support and care for future
patients.
Answering questionnaires may be a confrontational experience. This will be
explained during the recruitment of the participant, so that she has time to
consider this aspect of the study. Of course the participant can always
withdraw from the study.