You are here

  • Home
  • Archive
  • Volume 14, Issue 7
  • Development of a core data set for describing, measuring and reporting the learning curve in studies of novel invasive procedures: study protocol

Article Text

Article menu

Download PDFPDF

Surgery
Protocol
Development of a core data set for describing, measuring and reporting the learning curve in studies of novel invasive procedures: study protocol
  1. Jozel Ramirez1,2,
  2. Christin Hoffmann1,
  3. Neil Corrigan3,
  4. Matthew Kobetic1,4,
  5. Rhiannon Macefield1,
  6. Daisy Elliott1,
  7. Jane Blazeby1,
  8. Shelley Potter1,
  9. Deborah D Stocken3,
  10. Kerry Avery1,
  11. Natalie S Blencowe1
  1. 1National 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. 2North Bristol NHS Trust, Bristol, UK
  3. 3Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
  4. 4University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
  1. Correspondence to Dr Jozel Ramirez; jozel.ramirez{at}bristol.ac.uk

Abstract

Introduction 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.

Methods A core data set will be developed using methods adapted from the Core Outcome Measures in Effectiveness Trials 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 (eg, clinical innovators, clinicians, patients, methodologists, statisticians, journal editors and governance representatives) 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.

Ethics and dissemination The study is approved by an Institutional Ethics Committee at the University of Bristol (ref: 111362). Participants will complete written informed consent to participate. Dissemination strategies include scientific meeting presentations, peer-reviewed journal publications, patient engagement events, use of social media platforms, workshops and other events.

  • SURGERY
  • Adult surgery
  • Minimally invasive surgery
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2024-084252

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • X @jozelramirez20, @CS_Hoffmann, @NPCorrigan, @CSR_Bris, @daisy__elliott, @drshelleypotter, @KnlAvery, @NatalieBlencowe

    • Contributors NSB conceived and initiated the study. JR, NSB and CH designed the study and wrote the protocol. JR wrote the first draft of this manuscript. NSB and JB provided joint senior oversight. JR, CH, NC, MK, RM, DE, JB, SP, DDS, KA and NSB critically revised the protocol and manuscript. All authors have given final approval of the version to be published.

    • Funding 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 (NIHR203315). The views expressed are those of the author(s) and not necessarily those of the NIHR, the Department of Health and Social Care, the UK National Health Service, the Royal College of Surgeons England or the Medical Research Council (MRC). JR and MK are NIHR Academic Clinical Fellows. JB is an NIHR Senior Investigator. NSB is an MRC Clinician Scientist and SP is an NIHR Clinician Scientist.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, conduct, reporting or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.