Development of an electronic patient-reported outcome questionnaire for use at post-stroke follow-up: a complex intervention and programme theory development

Background: Stroke is a leading cause of death and disability globally, with aphasia affecting one-third of survivors, significantly impacting their quality of life. Digital health solutions like electronic Patient-Reported Outcome (ePRO) questionnaires can improve patient engagement by allowing patients to prepare for post-stroke consultations and communicate their difficulties in a digital format. However, survivors with aphasia, may struggle to use these technologies and internet-based tools due to navigation and comprehension difficultie potentially exacerbating healthcare inequities.Therefore, ePRO-questionnaires should be tailored for people with aphasia, to ensure they can benefit from their use. Aims: This methodological article provide insights into the development process of the Electronic Patient-Reported Outcome (e-PRO) questionnaire; Aphasia Customized electronic-PRO (ACe-PRO) intervention, an ePRO-questionnaire tailored for stroke survivors with aphasia by implementing aphasia friendly and accessibility principles. We outline the complex development steps, the guiding framework, and how contextual factors and stakeholder involvment informed the tailoring of ACe-PRO. Methods & Procedures: The development of ACe-PRO was guided by the UK Medical Research Council’s (MRC) framework for complex interventions and informed by a programme theory outlineing the mechanisms by which ACe-PRO would facilitate communication and improve consultations for peope with aphasia. The intervention was iteratively developed with input from key stakeholders (patients, healthcare professionals, and technical experts) and integrated into the electronic health record system EPIC used in the involved Danish stroke wards. Outcomes & Results: Developing ACe-PRO was a complex, iterative process requiring solutions for multiple challenges unique to aphasia in the post-stroke consultation context. Ongoing stakeholder involvement was pivotal in refining the tool, ensuring it aligned with clinical requirements and user needs. The integration into EPIC presented technical challenges carefully managed to maintain the tool’s perceived usability. This development highlights the intricate and multifaceted nature of creating a ePRO tailored to a vulnerable patient population and the need to adapt to both clinical and technical constraints. ACe-PRO’s efficacy remains to be tested. Conclusions: The development of ACe-PRO highlights the importance of robust theoretical frameworks, a strong evidence base, and stakeholder input. Adhering to these principles provide a solid foundation for feasibility testing ACe-PRO was developed with a focus on accessibility, for those with communicative and cognitive difficulties. Despite integration challenges, this rigorous approach was crucial in preparing the tool for clinical use. Future efforts will refine the tool and address technical issues to ensure usability in practice.