Developing a patient-oriented realist evaluation for COVID-19 vaccine implementation in Saskatchewan: a methodologic framework.

Background There is an urgent need to inform decision-making and safe delivery of vaccines in a timely manner. Our objective is to describe the methods we used to perform a patient-oriented realist evaluation of COVID-19 vaccination implementation in Saskatchewan, Canada, in order to understand the underlying mechanisms and contexts of vaccination implementation and vaccine uptake. Methods This methodology paper describes a patient-oriented, realist, mixed-method evaluation to assess COVID-19 vaccination implementation in Regina, Saskatoon and Prince Albert, Saskatchewan. The study comprised 3 iterative phases guided by Realist And Meta-narrative Evidence Synthesis: Evolving Standards II (RAMESES II). In phase 1 (January-February 2021), we developed the initial program theory, in phase 2 (March-May 2021), we tested and refined the initial program theory, and in phase 3 (June-July 2021), we established the final program theory. Three patient and family partners with different backgrounds and experiences were selected purposively from various locations (urban and rural) in Saskatchewan to engage collaboratively in the evaluation. Data analysis and synthesis occurred at all 3 phases of the project. We analysed qualitative data from phases 2 and 3 using a "retroductive" approach. We used quantitative data to compare outcomes from the 3 sites. Interpretation This protocol describes how we developed a final program theory for COVID-19 vaccination implementation with patient and family partners to show for whom, under what circumstances, how and why Saskatchewan's COVID-19 vaccination program has led to vaccine uptake. With patient and family partners' engagement, the evaluation findings will be shared with the Saskatchewan Health Authority and provincial government policy-makers and communications departments, published in peer-reviewed journals, presented at provincial or national conferences, and disseminated through any additional media identified by the patient and family partners.