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Article History

Accepted: 31 July 2022

First Online: 6 September 2022

Declarations

:

: OBS Cymru was funded by an Efficiency Through Technology grant from the Welsh Government. It was supported by Improvement Cymru (the national improvement body for NHS Wales) and the Wales Deanery through Clinical Leadership Fellows. Werfen loaned 10 Rotem Sigma devices to sites in Wales for the duration of the project and subsidised reagents required to perform assays. Werfen provided technical support, maintenance and annual service of all 12 Welsh devices, funded through the Welsh Government grant. The funders had no role in the study design, collection, analysis and interpretation of the data; writing of the report; and the decision to submit the paper for publication.

: RE Collis has received research support from CSL Behring, Werfen and Haemonetics. PW Collins has received honoraria from CSL Behring and Werfen and research support from CSL Behring, Werfen and Haemonetics. He has received support to attend a conference from CSL Behring. All other authors have no conflicts of interest to declare.

: In the UK, the need for submission to an ethics committee is governed by the Health Research Authority. The data published in this paper comply with the definition of service evaluation and, therefore, according to the rules in the UK, it did not require research ethics committee review or individual consent to report data []. It is the role of the lead research and development office to determine whether a project fulfils the criteria for research or service evaluation. In this case, the lead research and development office was at the Cardiff and Vale University Health Board and they concluded that the OBS Cymru quality improvement project was service evaluation according to NHS guidance. E-mail confirmation of this decision is included in the supplementary materials.

: Not applicable.

: Not applicable.

: Patient-level data cannot be made available; however, the STATA code and Excel model may be made available on request.

: Not applicable.

: RC and PC led the research under-pinning OBS Cymru, SB and RC obtained funding. SB, CS, KJ, MJ and RC designed OBS Cymru. SB and RC led the quality project. CS, KJ, MJ and PC managed the quality project. CS, KJ and MJ collected the clinical data. MD was responsible for health economic methodology, with contributions from SOC and GCR. SB, CS, KJ, RC and PC provided clinical expertise for health economic inputs. SOC and GCR critically reviewed the health economic analysis. MD, SB and SOC wrote the initial drafts of the manuscript. All authors contributed to revisions of the manuscript and all authors read and approved the final version.