Protocol to develop a core outcome set in incisional hernia surgery: the HarMoNY Project
Introduction Incisional hernia has an incidence of up to 20% following laparotomy and is associated with significant morbidity and impairment of quality of life. A variety of surgical strategies including techniques and mesh types are available to manage patients with incisional hernia. Previous wor...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/12/e059463.full |
| _version_ | 1828272633281511424 |
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| author | Ben Griffiths Neil Smart Lisa Massey Manuel López-Cano Marc Miserez Deena Harji Agneta Montgomery Christophe Thomas Stavros Antoniou Harsha Chandraratan B Todd Heniford Liam Horgan Ferdinand Koeckerling Filip Muysoms Benjamin Poulose Wolfgang Reinpold |
| author_facet | Ben Griffiths Neil Smart Lisa Massey Manuel López-Cano Marc Miserez Deena Harji Agneta Montgomery Christophe Thomas Stavros Antoniou Harsha Chandraratan B Todd Heniford Liam Horgan Ferdinand Koeckerling Filip Muysoms Benjamin Poulose Wolfgang Reinpold |
| author_sort | Ben Griffiths |
| collection | DOAJ |
| description | Introduction Incisional hernia has an incidence of up to 20% following laparotomy and is associated with significant morbidity and impairment of quality of life. A variety of surgical strategies including techniques and mesh types are available to manage patients with incisional hernia. Previous works have reported significant heterogeneity in outcome reporting for abdominal wall herniae, including ventral and inguinal hernia. This is coupled with under-reporting of important clinical and patient-reported outcomes. The lack of standardisation in outcome reporting contributes to reporting bias, hinders evidence synthesis and adequate data comparison between studies. This project aims to develop a core outcome set (COS) of clinically important, patient-oriented outcomes to be used to guide reporting of future research in incisional hernia.Methods This project has been designed as an international, multicentre, mixed-methods project. Phase I will be a systematic review of current literature to examine the current clinical and patient-reported outcomes for incisional hernia and abdominal wall reconstruction. Phase II will identify the outcomes of importance to all key stakeholders through in depth qualitative interviews. Phase III will achieve consensus on outcomes of most importance and for inclusion into a COS through a Delphi process. Phase IV will achieve consensus on the outcomes that should be included in a final COS.Ethics and dissemination The adoption of this COS into clinical and academic practice will be endorsed by the American, British and European Hernia Societies. Its utilisation in future clinical research will enable appropriate data synthesis and comparison and will enable better clinical interpretation and application of the current evidence base. This study has been registered with the Core Outcome Measures in Effectiveness Trials initiative.PROSPERO registration number CRD42018090084. |
| first_indexed | 2024-04-13T06:09:40Z |
| format | Article |
| id | doaj.art-56dcd65c280345819a25a327a50ef591 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-13T06:09:40Z |
| publishDate | 2022-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-56dcd65c280345819a25a327a50ef5912022-12-22T02:59:06ZengBMJ Publishing GroupBMJ Open2044-60552022-12-01121210.1136/bmjopen-2021-059463Protocol to develop a core outcome set in incisional hernia surgery: the HarMoNY ProjectBen Griffiths0Neil Smart1Lisa Massey2Manuel López-Cano3Marc Miserez4Deena Harji5Agneta Montgomery6Christophe Thomas7Stavros Antoniou8Harsha Chandraratan9B Todd Heniford10Liam Horgan11Ferdinand Koeckerling12Filip Muysoms13Benjamin Poulose14Wolfgang Reinpold15Great Ormond Street HospitalExeter Surgical Health Services Research Unit (HeSRU), Royal Devon & Exeter Hospital, Exeter, Devon, UK2 Surgery, Royal Devon and Exeter NHS Foundation Trust, Exeter, UKAbdominal Wall Surgery Unit, Department of General Surgery, Hospital Universitari Vall d`Hebron, Universitat Autònoma de Barcelona, Barcelona, SpainAbdominal Surgery, Leuven University Hospitals Leuven, Leuven, Flanders, Belgium1 Newcastle Centre for Bowel Disease, Royal Victoria Infirmary, Newcastle Upon Tyne, UK2Department of Surgery, Skåne University Hospital, Malmö, SwedenNorthern Surgical Trainees Research Association, Newcastle, UKMediterranean Hospital of Cyprus, Limassol, CyprusGeneral Surgery, Notra Dame University, Murdoch, Western Australia, AustraliaCarolinas Medical Center, Charlotte, North Carolina, USANorthumbria Healthcare NHS Foundation Trust, North Shields, UKVivantes, Berlin, GermanyMaria Middelares, Ghent, BelgiumThe Ohio State University Wexner Medical Center, Columbus, Ohio, USAGross Sand Hospital, Hamburg, UKIntroduction Incisional hernia has an incidence of up to 20% following laparotomy and is associated with significant morbidity and impairment of quality of life. A variety of surgical strategies including techniques and mesh types are available to manage patients with incisional hernia. Previous works have reported significant heterogeneity in outcome reporting for abdominal wall herniae, including ventral and inguinal hernia. This is coupled with under-reporting of important clinical and patient-reported outcomes. The lack of standardisation in outcome reporting contributes to reporting bias, hinders evidence synthesis and adequate data comparison between studies. This project aims to develop a core outcome set (COS) of clinically important, patient-oriented outcomes to be used to guide reporting of future research in incisional hernia.Methods This project has been designed as an international, multicentre, mixed-methods project. Phase I will be a systematic review of current literature to examine the current clinical and patient-reported outcomes for incisional hernia and abdominal wall reconstruction. Phase II will identify the outcomes of importance to all key stakeholders through in depth qualitative interviews. Phase III will achieve consensus on outcomes of most importance and for inclusion into a COS through a Delphi process. Phase IV will achieve consensus on the outcomes that should be included in a final COS.Ethics and dissemination The adoption of this COS into clinical and academic practice will be endorsed by the American, British and European Hernia Societies. Its utilisation in future clinical research will enable appropriate data synthesis and comparison and will enable better clinical interpretation and application of the current evidence base. This study has been registered with the Core Outcome Measures in Effectiveness Trials initiative.PROSPERO registration number CRD42018090084.https://bmjopen.bmj.com/content/12/12/e059463.full |
| spellingShingle | Ben Griffiths Neil Smart Lisa Massey Manuel López-Cano Marc Miserez Deena Harji Agneta Montgomery Christophe Thomas Stavros Antoniou Harsha Chandraratan B Todd Heniford Liam Horgan Ferdinand Koeckerling Filip Muysoms Benjamin Poulose Wolfgang Reinpold Protocol to develop a core outcome set in incisional hernia surgery: the HarMoNY Project BMJ Open |
| title | Protocol to develop a core outcome set in incisional hernia surgery: the HarMoNY Project |
| title_full | Protocol to develop a core outcome set in incisional hernia surgery: the HarMoNY Project |
| title_fullStr | Protocol to develop a core outcome set in incisional hernia surgery: the HarMoNY Project |
| title_full_unstemmed | Protocol to develop a core outcome set in incisional hernia surgery: the HarMoNY Project |
| title_short | Protocol to develop a core outcome set in incisional hernia surgery: the HarMoNY Project |
| title_sort | protocol to develop a core outcome set in incisional hernia surgery the harmony project |
| url | https://bmjopen.bmj.com/content/12/12/e059463.full |
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