Assessment of a colposcopic scoring system (Swedescore) to reduce the number of cervical biopsies: a protocol for a clinical multicentre non-randomised intervention study in Denmark.

Autor:	Knudsen AS; Department of Clinical Medicine, Aarhus University, Aarhus, Midtjylland, Denmark.; Department of Obstetrics and Gynecology, Gødstrup Hospital, Herning 7400, Denmark., Randrup TH; Department of Obstetrics and Gynecology, Gødstrup Hospital, Herning 7400, Denmark., Kesmodel US; Department of Clinical Medicine, Aarhus University, Aarhus, Midtjylland, Denmark.; Department of Obstetrics & Gynecology, Aalborg University Hospital, Aalborg, The North Denmark Region, Denmark., Booth B; The Research Unit of Obstetrics & Gynecology, Odense University Hospital, Odense University Hospital, Odense, The Region of Southern Denmark, Denmark.; Department of Obstetrics & Gynecology, Randers Regional Hospital, Randers, Denmark., Gustafson L; Department of Public Health Programmes, Randers Regional Hospital, Randers, Denmark.; Department of Obstetrics and Gynecology, Aarhus Universitetshospital, Aarhus, Denmark., Tropé A; Section for Cervical Cancer Screening, Cancer Registry of Norway, Oslo, Norway., Strander B; Department of Obstetrics and Gynecology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden., Nieminen P; Helsinki University, Finland, Helsingin Yliopisto, Helsinki, Finland., Hammer A; Department of Clinical Medicine, Aarhus University, Aarhus, Midtjylland, Denmark ahlauridsen@clin.au.dk.; Department of Obstetrics and Gynecology, Gødstrup Hospital, Herning 7400, Denmark.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Dec 15; Vol. 14 (12), pp. e085382. Date of Electronic Publication: 2024 Dec 15.
DOI:	10.1136/bmjopen-2024-085382
Abstrakt:	Introduction: Colposcopy is a standard procedure for evaluating cervical abnormalities and collecting cervical biopsies. The procedure is associated with intra- and inter-observer variation. A colposcopic scoring system, Swedescore, has been designed to standardise and facilitate colposcopy training. Swedescore has performed well in a routine clinical setting when used by expert colposcopists to find or exclude high-grade lesions. Danish clinical guidelines for colposcopy differ from other countries, as they recommend collecting four cervical biopsies in all women regardless of risk factors or colposcopy findings. Swedescore has never been examined to assess the reduction of cervical biopsies in a real-world clinical setting. This study aims to investigate whether the implementation of Swedescore can optimise the diagnostic work-up for whom the collection of biopsies can be safely omitted or reduced. Methods and Analysis: The design is a clinical multicentre non-randomised intervention study in Denmark. According to a power calculation, we will need to include 586 women referred for colposcopy. Colposcopy with Swedescore will be compared with conventional colposcopy with no Swedescore. Cervical biopsies will be divided into two separate vials (target and random biopsies). The primary outcome will be normal or cervical intraepithelial neoplasia grade 1 detected in cervical biopsies. χ 2 and logistic regression will be used to compare estimates between arms. Ethics and Dissemination: The study protocol has been submitted to the Ethical Committee in Central Denmark region and is not notifiable to the Committee (j.no.: 1-10-72-124-22). Results will be published in a peer-reviewed journal and presented at scientific meetings. Trial Registration Number: NCT05870787. Protocol Version: Version 3 (date 12. November 2024). Competing Interests: Competing interests: AH has received reagents for free from Roche Denmark for another study and a consulting fee from Exeltis. This does not influence the scientific work or the submission of this manuscript. The remaining authors have no conflicts of interest to declare. Inclusion sites have no financial or competing interests in the study. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)
Databáze:	MEDLINE
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