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
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....
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BMJ Publishing Group
2024-12-01
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| author | Ulrik Schiøler Kesmodel Ameli Tropé Anne Hammer Pekka Nieminen Björn Strander Berit Booth Ane-Kersti Skaarup Knudsen Tina Hovgaard Randrup Line Gustafson |
| author_facet | Ulrik Schiøler Kesmodel Ameli Tropé Anne Hammer Pekka Nieminen Björn Strander Berit Booth Ane-Kersti Skaarup Knudsen Tina Hovgaard Randrup Line Gustafson |
| author_sort | Ulrik Schiøler Kesmodel |
| collection | DOAJ |
| description | 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. χ2 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). |
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| issn | 2044-6055 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-7edfb465040e446286f027cc26fcc2c02025-08-20T02:36:59ZengBMJ Publishing GroupBMJ Open2044-60552024-12-01141210.1136/bmjopen-2024-085382Assessment of a colposcopic scoring system (Swedescore) to reduce the number of cervical biopsies: a protocol for a clinical multicentre non-randomised intervention study in DenmarkUlrik Schiøler Kesmodel0Ameli Tropé1Anne Hammer2Pekka Nieminen3Björn Strander4Berit Booth5Ane-Kersti Skaarup Knudsen6Tina Hovgaard Randrup7Line Gustafson81 Department of Clinical Medicine, Aarhus University, Aarhus, Midtjylland, Denmark8 Section for Cervical Cancer Screening, Cancer Registry of Norway, Oslo, Norway1 Department of Clinical Medicine, Aarhus University, Aarhus, Midtjylland, Denmark10 Helsinki University, Finland, Helsingin Yliopisto, Helsinki, Finland9 Department of Obstetrics and Gynecology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden4 The Research Unit of Obstetrics & Gynecology, Odense University Hospital, Odense University Hospital, Odense, The Region of Southern Denmark, Denmark1 Department of Clinical Medicine, Aarhus University, Aarhus, Midtjylland, Denmark2 Department of Obstetrics and Gynecology, Gødstrup Hospital, Herning 7400, Denmark6 Department of Public Health Programmes, Randers Regional Hospital, Randers, DenmarkIntroduction 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. χ2 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).https://bmjopen.bmj.com/content/14/12/e085382.full |
| spellingShingle | Ulrik Schiøler Kesmodel Ameli Tropé Anne Hammer Pekka Nieminen Björn Strander Berit Booth Ane-Kersti Skaarup Knudsen Tina Hovgaard Randrup Line Gustafson 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/14/12/e085382.full |
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