Evaluating the high-volume, low-complexity surgical hub programme:a qualitative research protocol and further reflection on designing big, complex qualitative studies

In this paper, we outline our qualitative protocol for the largest, independent, mixed-method, evaluation of the High Volume-Low Complexity Surgical Hubs programme in England – The MEASURE study. In addition to serving as a protocol paper, we outline the key methodological considerations and adaptations that are needed when designing big qualitative studies – complex (multi-site, multi-stakeholder), multi-method (e.g. interviews, observations, documents) qualitative research involving a large number of participations (n=100+). This paper expands on our previous methodological work, where we used our experience of undertaking a big qualitative study as part of a mixed-method evaluation of a national emergency care-based initiative, to outline the methodological considerations and uncertainties for designing and analysing “big” qualitative studies. In this paper, we put these considerations into practice by providing a transparent account of our qualitative study design. The methodological reflections which we present are centred around the areas where we feel there is the most uncertainty for big qualitative research: study design, sampling (of case sites and stakeholders) and analysis. Underpinning this uncertainty are broader challenges which utilising this approach incite. Namely, that striving for both breadth (national-level insights) and depth (local variation and context), challenges paradigmatic norms and expectations and forces either methodological innovation, or the adaption of existing qualitative methods. We hope this paper provides transparency and insight into an area of qualitative research which has, potentially due to a perception of “safety in numbers” been inherently trusted and rarely scrutinised. Ultimately, we hope that by providing a transparent account of our study design and the challenges we have faced that we continue to encourage discussion and innovation in this evolving area of qualitative research.