Outcome selection, measurement and reporting for new surgical procedures and devices: a systematic review of IDEAL/IDEAL-D studies to inform development of a core outcome set

R. C. Macefield*, N. Wilson, C. Hoffmann, J. M. Blazeby, A. G.K. McNair, K. N.L. Avery, S. Potter

*Corresponding author for this work

Research output: Contribution to journalReview article (Academic Journal)peer-review

9 Citations (Scopus)
45 Downloads (Pure)

Abstract

Background
Outcome selection, measurement and reporting for the evaluation of new surgical procedures and devices is inconsistent and lacks standardization. A core outcome set may promote the safe and transparent evaluation of surgical innovations. This systematic review examined outcome selection, measurement and reporting in studies conducted within the IDEAL (Idea, Development, Exploration, Assessment and Long‐term monitoring) framework to examine current practice and inform the development of a core outcome set for early‐phase studies of surgical procedures/devices.

Methods
Web of Science and Scopus citation searches were performed to identify author‐reported IDEAL/IDEAL‐D studies for any surgical procedure/device. Outcomes were extracted verbatim, including contextual information regarding outcome selection and measurement. Outcomes were categorized to inform a conceptual framework of outcome domains relevant to evaluating innovation.

Results
Some 48 studies were identified. Outcome selection, measurement and reporting varied widely across studies in different IDEAL stages. From 1737 outcomes extracted, 22 domains specific to evaluating innovation were conceptualized under seven broad categories: procedure completion success/failure; modifications; unanticipated events; surgeons' experiences; patients' experiences; resource use specific to the innovative procedure/device; and other innovation‐specific outcomes. Most innovation‐specific outcomes were measured and reported in only a small number of studies.

Conclusion
This review highlighted the need for guidance and standardization in outcome selection and reporting in the evaluation of new surgical procedures/devices. Novel outcome domains specific to innovation have been identified to establish a core outcome set for future evaluations of surgical innovations.
Original languageEnglish
Pages (from-to)1072-1083
Number of pages13
JournalBJS Open
Volume4
Issue number6
Early online date4 Oct 2020
DOIs
Publication statusPublished - Dec 2020

Bibliographical note

Funding Information:
information National Institute for Health Research Bristol Biomedical Research CentreK.N.L.A. and S.P. are joint senior authors. The authors acknowledge the COHESIVE study group and study steering group for their advice while undertaking this review, and K. Chalmers, Bristol Centre for Surgical Research, University of Bristol, for help with screening abstracts. S.P. is a National Institute for Health Research (NIHR) Clinician Scientist (CS-2016-16-019). A.G.K.M. is an NIHR Clinician Scientist (NIHR-CS-2017-17-010). J.M.B. is an NIHR Senior Investigator. This work was funded by the NIHR Biomedical Research Centre at the University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol. This work was supported by the Royal College of Surgeons of England Bristol Surgical Trials Centre and the Medical Research Council (MRC) Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures (ConDuCT-II) Hub for Trials Methodology Research (MR/K025643/1). The views and opinions expressed in this publication are those of the authors and not necessarily those of the UK National Health Service, NIHR, Department of Health and Social Care, Royal College of Surgeons of England or MRC. Disclosure: The authors declare no conflict of interest.

Publisher Copyright:
© 2020 The Authors. BJS Open published by John Wiley & Sons Ltd on behalf of British Journal of Surgery Society.

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