Development of a core data set for describing, measuring and reporting the learning curve in studies of novel invasive procedures

The introduction of novel surgical techniques and procedures remains poorly regulated and standardised. Although the learning curve associated with invasive procedures is a critical part of innovation, it is currently inconsistently defined, measured and reported. This study aims to develop a core data set that can be applied in all studies describing or measuring the learning curve in novel invasive procedures.

A core data set will be developed using methods adapted from the Core Outcome Measures in Effectiveness Trials (COMET) initiative. The study will involve three phases:
1. Identification of a comprehensive list of data items through a) an umbrella review of existing systematic reviews on the learning curve in surgery and b) qualitative interviews with key stakeholders.
2. Key stakeholders (e.g. clinical innovators, clinicians, methodologists, statisticians, journal editors, governance representatives, patients) will complete a Delphi survey to score the importance of each data item, generating a shortened list.
3. Consensus meeting(s) with stakeholders to discuss and agree on the final core data set.

A generic core outcome set for surgical innovation has recently been developed (the COHESIVE core outcome set) to specify what outcomes are important (https://bmjopen.bmj.com/content/9/9/e029574.long). Operators’/surgeons’ experience of performing an innovative procedure was identified as one of eight core outcome domains and a recommended next step is to identify how it should be measured. Detailed guidance for describing, measuring and reporting the learning curve in surgical innovation can complement this work to ultimately improve standardisation and promote robust evaluation in this area.

Contributors

Ramirez, Jozel (1,3) - principal investigator/first author
Hoffmann, Christin (1)
Corrigan, Neil (2)
Kobetic, Matthew (1,4)
Macefield, Rhiannon (1)
Elliott, Daisy (1)
Blazeby, Jane (1)
Potter, Shelley (1,3)
Stocken, Deborah D (2)
Avery, Kerry (1)
Blencowe, Natalie S (1) - supervisor

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
2. Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
3. North Bristol NHS Trust, Bristol, UK
4. University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK

Further Study Information

Current Stage: Ongoing
Date: January 2023 - January 2025
Funding source(s): This study was supported by the National Institute for Health and Care Research (NIHR) Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. JR and MK are NIHR Academic Clinical Fellows. JB is an NIHR Senior Investigator. NB is an MRC Clinician Scientist and SP is an NIHR Clinician Scientist.

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Method(s)

- Consensus meeting
- Delphi process
- Interview
- Survey
- Systematic review

Methods for developing the core data set will be divided into 3 phases (described in more detail in the brief summary above):

Phase 1: Content elicitation and generation of long list of items (systematic review and qualitative interviews)
Phase 2: Delphi questionnaire surveys and data prioritisation
Phase 3: Consensus meeting(s) and finalisation of core data set

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