Open AccessA Novel Mixed-Methods Platform Study Protocol for Investigating New Surgical Devices, with Embedded Shared Learning: Ibra-net Breast Lesion Localisation Study
Author(s) -
Hannah L. Bromley,
Rajiv Dave,
Chris Holcombe,
Shelley Potter,
Anthony Maxwell,
Cliona C. Kirwan,
Senthurun Mylvaganam,
Suzanne Elgammal,
Jenna Morgan,
Sue Down,
Tahir Masudi,
Amtul Sami,
Nicola Barnes,
James Harvey
Publication year - 2021
Publication title -
international journal of surgery protocols
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.291
H-Index - 4
ISSN - 2468-3574
DOI - 10.29337/ijsp.136
Subject(s) - medicine , protocol (science) , intervention (counseling) , thematic analysis , medical physics , focus group , qualitative research , nursing , pathology , alternative medicine , social science , marketing , sociology , business
New medical devices must have adequate research, such that outcomes are known, enabling patients to be consented with knowledge of the safety and efficacy of the device to be implanted. Device trials are challenging due to the learning curve and iterative assessment of best practice. This study is designed to pilot a national collaborative approach to medical device introduction by breast surgeons in the UK, using breast localisation devices as an exemplar. The aim is to develop an effective and transferable surgical device platform protocol design, with embedded shared learning.