Background: A patient decision aid (PtDA) can support shared decision making (SDM) in preference-sensitive care,
with more than one clinically applicable treatment option. The development of a PtDA is a complex process, involving
several steps, such as designing, developing and testing the draft with all the stakeholders, known as alpha testing. This
is followed by testing in ‘real life’ situations, known as beta testing, and then finalising the definite version.
Our aim was developing and alpha testing a PtDA for primary treatment of early stage breast cancer, ensuring that the
tool is considered relevant, valid and feasible by patients and professionals.
Methods: Our qualitative descriptive study applied various methods including face-to-face think-aloud interviews,
a focus group and semi-structured telephone interviews. The study population consisted of breast cancer patients facing
the choice between breast-conserving therapy with or without preceding neo-adjuvant chemotherapy and mastectomy,
and professionals involved in breast cancer care in dedicated multidisciplinary breast cancer teams.
Results: A PtDA was developed in four iterative test rounds, taking nearly 2 years, involving 26 patients and
26 professionals. While the research group initially opted for simplicity for the sake of implementation, the
clinicians objected that the complexity of the decision could not be ignored. Other topics of concern were
the conflicting views of professionals and patients regarding side effects, the amount of information and
how to present it.
Conclusion: The development was an extensive process, because the professionals rejected the simplifications proposed
by the research group. This resulted in the development of a completely new draft PtDA, which took double the expected
time and resources. The final version of the PtDA appeared to be well-appreciated by professionals and patients, although
its acceptability will only be proven in actual practice (beta testing)