Comparative efficacy and complication rates after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE Group
Introduction Local treatments for cervical intraepithelial neoplasia (CIN) and microinvasive disease remove or ablate a cone-shaped part of the uterine cervix containing the abnormal cells. A trend toward less radical techniques has raised concerns that this may adversely impact the rates of precanc...
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BMJ Publishing Group
2019-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/8/e028008.full |
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| author | Orestis Efthimiou Georgia Salanti Huseyin Naci Philip Bennett Antonios Athanasiou Areti Angeliki Veroniki Ilkka Kalliala Sarah Bowden Maria Paraskevaidi Pierre Martin-Hirsch Evangelos Paraskevaidis Maria Kyrgiou |
| author_facet | Orestis Efthimiou Georgia Salanti Huseyin Naci Philip Bennett Antonios Athanasiou Areti Angeliki Veroniki Ilkka Kalliala Sarah Bowden Maria Paraskevaidi Pierre Martin-Hirsch Evangelos Paraskevaidis Maria Kyrgiou |
| author_sort | Orestis Efthimiou |
| collection | DOAJ |
| description | Introduction Local treatments for cervical intraepithelial neoplasia (CIN) and microinvasive disease remove or ablate a cone-shaped part of the uterine cervix containing the abnormal cells. A trend toward less radical techniques has raised concerns that this may adversely impact the rates of precancerous and cancerous recurrence. However, there has been no strong evidence to support such claims. We hereby describe a protocol of a systematic review and network meta-analysis that will update the evidence and compare all relevant treatments in terms of efficacy and complications.Methods and analysis Literature searches in electronic databases (CENTRAL, MEDLINE, EMBASE) or trial registries will identify published and unpublished randomised controlled trials (RCTs) and cohort studies comparing the efficacy and complications among different excisional and ablative techniques. The excisional techniques include cold knife, laser or Fischer cone, large loop or needle excision of the transformation zone and the ablative radical point diathermy, cryotherapy, cold coagulation or laser ablation. The primary outcome will be residual/recurrent disease defined as abnormal histology or cytology of any grade, while secondary outcomes will include treatment failure rates defined as high-grade histology or cytology, histologically confirmed CIN1+ or histologically confirmed CIN2+, human papillomavirus positivity rates, involved margins rates, bleeding and cervical stenosis rates. We will assess the risk of bias in RCTs and observational studies using tools developed by the Cochrane Collaboration. Two authors will independently assess study eligibility, abstract the data and assess the risk of bias. Random-effects meta-analyses and network meta-analyses will be conducted using the OR for dichotomous outcomes and the mean difference for continuous outcomes. The quality of the evidence for the primary outcome will be assessed using the CINeMA (Confidence In Network Meta-Analysis) tool.Ethics and dissemination Ethical approval is not required. We will disseminate findings to clinicians, policy-makers, patients and the public.PROSPERO registration number CRD42018115508. |
| format | Article |
| id | doaj-art-569d27d1d4dc4cb4a45e564e904b4b82 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-08-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-569d27d1d4dc4cb4a45e564e904b4b822025-08-20T02:48:09ZengBMJ Publishing GroupBMJ Open2044-60552019-08-019810.1136/bmjopen-2018-028008Comparative efficacy and complication rates after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE GroupOrestis Efthimiou0Georgia Salanti1Huseyin Naci2Philip Bennett3Antonios Athanasiou4Areti Angeliki Veroniki5Ilkka Kalliala6Sarah Bowden7Maria Paraskevaidi8Pierre Martin-Hirsch9Evangelos Paraskevaidis10Maria Kyrgiou11Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland4 Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerlandassociate professor3Rheumatology and Radiology departments at hospitals at Zealand, Jutland and Funen, Copenhagen, Slagelse, Aarhus, Silkeborg, Odense, Hjørring and Graasten, Denmarkclinical research fellowKnowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael’s Hospital, Unity Health Toronto, Toronto, Ontario, Canada5 Department of Obstetrics and Gynaecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland1 Department of Surgery and Cancer, Faculty of Medicine, Institute of Reproductive and Developmental Biology, Imperial College London, London, UKDepartment of Metabolism, Digestion and Reproduction, Faculty of Medicine, Institute of Reproductive and Developmental Biology, Imperial College, London, UK7 Department of Gynaecologic Oncology, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK8 Department of Obstetrics and Gynaecology, University of Ioannina and University Hospital of Ioannina, Ioannina, Greeceprofessor of gynaecological oncology, Institute of Reproductive and Developmental BiologyIntroduction Local treatments for cervical intraepithelial neoplasia (CIN) and microinvasive disease remove or ablate a cone-shaped part of the uterine cervix containing the abnormal cells. A trend toward less radical techniques has raised concerns that this may adversely impact the rates of precancerous and cancerous recurrence. However, there has been no strong evidence to support such claims. We hereby describe a protocol of a systematic review and network meta-analysis that will update the evidence and compare all relevant treatments in terms of efficacy and complications.Methods and analysis Literature searches in electronic databases (CENTRAL, MEDLINE, EMBASE) or trial registries will identify published and unpublished randomised controlled trials (RCTs) and cohort studies comparing the efficacy and complications among different excisional and ablative techniques. The excisional techniques include cold knife, laser or Fischer cone, large loop or needle excision of the transformation zone and the ablative radical point diathermy, cryotherapy, cold coagulation or laser ablation. The primary outcome will be residual/recurrent disease defined as abnormal histology or cytology of any grade, while secondary outcomes will include treatment failure rates defined as high-grade histology or cytology, histologically confirmed CIN1+ or histologically confirmed CIN2+, human papillomavirus positivity rates, involved margins rates, bleeding and cervical stenosis rates. We will assess the risk of bias in RCTs and observational studies using tools developed by the Cochrane Collaboration. Two authors will independently assess study eligibility, abstract the data and assess the risk of bias. Random-effects meta-analyses and network meta-analyses will be conducted using the OR for dichotomous outcomes and the mean difference for continuous outcomes. The quality of the evidence for the primary outcome will be assessed using the CINeMA (Confidence In Network Meta-Analysis) tool.Ethics and dissemination Ethical approval is not required. We will disseminate findings to clinicians, policy-makers, patients and the public.PROSPERO registration number CRD42018115508.https://bmjopen.bmj.com/content/9/8/e028008.full |
| spellingShingle | Orestis Efthimiou Georgia Salanti Huseyin Naci Philip Bennett Antonios Athanasiou Areti Angeliki Veroniki Ilkka Kalliala Sarah Bowden Maria Paraskevaidi Pierre Martin-Hirsch Evangelos Paraskevaidis Maria Kyrgiou Comparative efficacy and complication rates after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE Group BMJ Open |
| title | Comparative efficacy and complication rates after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE Group |
| title_full | Comparative efficacy and complication rates after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE Group |
| title_fullStr | Comparative efficacy and complication rates after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE Group |
| title_full_unstemmed | Comparative efficacy and complication rates after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE Group |
| title_short | Comparative efficacy and complication rates after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE Group |
| title_sort | comparative efficacy and complication rates after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer protocol for a systematic review and network meta analysis from the circle group |
| url | https://bmjopen.bmj.com/content/9/8/e028008.full |
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