Irene Göttgens

Human Centered Design in Health Research 133 5 In this review the diverse reporting formats challenged our ability to assess the quality of the studies from an evidence-based perspective. While initial guidelines have been proposed to improve reporting of design studies in health research, this is still an area in development.[14] The guidelines by Bazzano et al (2020) represent a first detailed overview of reporting items for health research that include design approaches. Although we acknowledge that this reporting guideline is an important first step towards improving transparency, evaluability, and wider dissemination of design approaches in health research, it is, however, debatable whether the application of these guidelines is feasible in the context of health research manuscripts. The level of detail that the Bazzano guidelines propose, implies that the design research component should be reported as a standalone article, separate from the connected empirical studies. Many of the design studies included in this review offered limited details about their multi-method design cycles, possibly due to the word count limits most scientific journals apply. It would be almost impossible to describe a multi-method design process in adequate detail and report effectively on the research and design outcomes in a single manuscript. Applying the Bazzano guidelines with rigor is likely to result in the reporting of separate design cycles across multiple manuscripts and essential findings for the design process may appear fragmented or be lost among the reports that are published separately. It could be argued, however, that the separate publication of multiple waves of data collections in design research is preferable for both researchers and reviewers to support the validity, reliability, and reproducibility of design-based health research. Rather than aiming for complex integrated manuscripts, multiple publications would allow researchers to report in more detail on both methods and findings, also allowing for easier critical appraisal and quality assessment by reviewers. Beside traditional research articles, innovative publication formats such as registered reports could be used to submit design research protocols and results which are judged on their methodological robustness, rather than the potential novelty of the findings.[114] To address the issue of potential fragmented data publication, we recommend registering the design research protocols in a research registry. This would allow for systematic referencing to previous design activities, even when results are not published, yet. Active engagement of stakeholders is one of the key principles of the human-centred design approach. Stakeholders can be defined as: “individuals, organizations or communities that have a direct interest in the process and outcomes of a project, research or policy endeavour”.[115] In healthcare innovation the engagement of diverse stakeholders is essential to the development of a shared agenda for responsible innovation and for the co-creation of social value.[116] However, a multi-stakeholder

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