Identification of outcomes to inform the development of a core outcome set for surgical innovation: a targeted review of case studies of novel surgical devices
Jane M Blazeby,
Angus G K McNair,
Natalie S Blencowe,
Nicholas Wilson,
Barry G Main,
Shelley Potter,
Kerry N L Avery,
Matthew J Edmondson,
Rhiannon C Macefield,
Christin Hoffmann,
Rachael L Miller,
Emily N Kirkham
Affiliations
Jane M Blazeby
1National Institute for Health Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK
Angus G K McNair
National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK
Natalie S Blencowe
National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK
Nicholas Wilson
Population Health Sciences, University of Bristol, Bristol, UK
Barry G Main
7 Bristol Dental School, University of Bristol, Bristol, UK
Shelley Potter
National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK
Kerry N L Avery
National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK
Matthew J Edmondson
2 Anaesthetics Department, Musgrove Park Hospital, Somerset NHS Foundation, Taunton, UK
Rhiannon C Macefield
National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK
Christin Hoffmann
National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK
Rachael L Miller
1 National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK
Emily N Kirkham
4 Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK
Objective Outcome selection and reporting in studies of novel surgical procedures and devices lacks standardisation, hindering safe and effective evaluation. A core outcome set (COS) to measure and report in all studies of surgical innovation is needed. We explored outcomes in a specific sample of innovative surgical device case studies to identify outcome domains specifically relevant to innovation to inform the development of a COS.Design A targeted review of 11 purposive selected case studies of innovative surgical devices.Methods Electronic database searches in PubMed (July 2018) identified publications reporting the introduction and evaluation of each device. Outcomes were extracted and categorised into domains until no new domains were conceptualised. Outcomes specifically relevant to evaluating innovation were further scrutinised.Results 112 relevant publications were identified, and 5926 outcomes extracted. Heterogeneity in study type, outcome selection and reporting was observed across surgical devices. Categorisation of outcomes was performed for 2689 (45.4%) outcomes into five broad outcome domains. Outcomes considered key to the evaluation of innovation (n=66; 2.5%) were further categorised as surgeon/operator experience (n=40; 1.5%), unanticipated events (n=15, 0.6%) and modifications (n=11; 0.4%).Conclusion Outcome domains unique to evaluating innovative surgical devices have been identified. Findings have been combined with multiple other data sources relevant to the evaluation of surgical innovation to inform the development of a COS to measure and report in all studies evaluating novel surgical procedures/devices.
