Twiddy, M. orcid.org/0000-0002-3794-1598, Jackson, R. orcid.org/0000-0003-1368-4336, Gordon, K. orcid.org/0000-0003-1483-0657 et al. (4 more authors) (2025) Developing a surgical trial intervention protocol: using qualitative methods in the operating theatre. Trials, 26 (1). 368. ISSN: 1745-6215
Abstract
Introduction
Surgery is a complex intervention, so it is important to establish standards for both the standard and ‘novel’ procedures in randomized controlled trials (RCTs) that demonstrate that interventions are delivered as intended to fully understand and explain trial results. This study set out to identify and agree the key steps of a surgical intervention to be tested in the ‘near infrared fluorescent imaging in thyroid surgery’ (NIFTy) RCT to inform development of the surgical protocol, and trial materials.
Method
Qualitative case studies of surgeries were undertaken prior to undertaking an RCT to evaluate the potential of a device to reduce post-surgical hypoparathyroidism. Each case study involved non-participant observation, video capture of total and completion thyroidectomies, and interviews with surgeons. A typology of operative steps was constructed. Two surveys were undertaken (1) to identify current practice around parathyroid identification; and (2) to determine surgeon views on the surgical steps. An international expert panel of six clinicians met to review findings and agree on the surgical steps (mandatory/optional) for operations in the RCT, including timing for use of fluorescence and the data items to be collected.
Results
Ten case studies were undertaken. Video, observation and interview data found differences in surgical approach were driven only by pathology. A typology detailing the surgical steps and points where imaging could be used was developed. Sixty-four surgeons responded to survey 1; three-quarters always looked for parathyroid glands when operating. Forty surgeons responded to survey 2; capsular dissection of the thyroid lobe, preservation of parathyroid pedicle, and clinical assessment were important for parathyroid preservation. The expert panel agreed the key surgical components. These informed key data collection in NIFTy. Two specific surgical steps were strongly recommended and three mandated.
Conclusion
Qualitative research in the operating theatre, prior to RCT allowed the identification of key components of the surgical intervention. The surveys and expert panel provided certainty about the acceptability of the surgical protocol and identified the core data to collect to evidence surgical decision making prior to embarking on the RCT. This qualitative process achieved clinical buy-in, improved trial conduct and allowed full explanation of the subsequent trial results.
Trial registration
ISRCTN59074092. Registration date: 07/03/2022.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © The Author(s) 2025. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. |
Keywords: | Randomised controlled trial; Qualitative research methods; Surgery; Intervention standardization; Consensus |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Medicine and Population Health |
Date Deposited: | 29 Sep 2025 14:44 |
Last Modified: | 29 Sep 2025 14:44 |
Status: | Published |
Publisher: | Springer Science and Business Media LLC |
Refereed: | Yes |
Identification Number: | 10.1186/s13063-025-09088-y |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:232339 |