Table 1

Mixed-methods research objectives, procedures and analysis

ObjectiveStudy procedureSampling and participantsData analysis
To assess stakeholders’ needs and preferences concerning decision-making about health data use and sharingHospital-based surveyConsecutive sampling at two reference centres for rare diseases of an estimated 200 patients, 500 informal carers, 70 health professionals and 30 technical staffDescriptive and regression analysis, adjusting for confounders
To understand stakeholders’ expectations and perspectives about public and patient involvement in health data decision-making processesQualitative interviewsSubsample of quantitative study selected through heterogeneity sampling including an estimated 30 patients, 30 informal carers, 15 health professionals and 10 technical staffInductive and deductive analysis informed by the Modified Participation Chain Model
To coproduce a model for public and patient involvement in health data governanceScenario-based workshopsSubsample of quantitative study selected through heterogeneity sampling including 8–12 participants per stakeholder group in the intragroup round and three participants per stakeholder group in the mixed-group round (total of 12 participants)Deductive and inductive approach to scenario development followed by inductive analysis of workshops data