Outcomes for Pressure Ulcer Trials (OUTPUTs): protocol for the development of a core domain set for trials evaluating the clinical efficacy or effectiveness of pressure ulcer prevention interventions
Abstract Background Core outcome sets (COS) are being developed in many clinical areas to increase the quality and comparability of clinical trial results as well as to ensure their relevance for patients. A COS represents an agreed standardized set of outcomes that describes the minimum that should...
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| Format: | Article |
| Language: | English |
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BMC
2019-07-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-019-3543-9 |
| _version_ | 1819147034114916352 |
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| author | Anna Lechner Jan Kottner Susanne Coleman Delia Muir Heather Bagley Dimitri Beeckman Wendy Chaboyer Janet Cuddigan Zena Moore Claudia Rutherford Jochen Schmitt Jane Nixon Katrin Balzer |
| author_facet | Anna Lechner Jan Kottner Susanne Coleman Delia Muir Heather Bagley Dimitri Beeckman Wendy Chaboyer Janet Cuddigan Zena Moore Claudia Rutherford Jochen Schmitt Jane Nixon Katrin Balzer |
| author_sort | Anna Lechner |
| collection | DOAJ |
| description | Abstract Background Core outcome sets (COS) are being developed in many clinical areas to increase the quality and comparability of clinical trial results as well as to ensure their relevance for patients. A COS represents an agreed standardized set of outcomes that describes the minimum that should be consistently reported in all clinical trials of a defined area. It comprises a core domain set (defining what core outcomes should be measured) and a core measurement set (defining measurement/assessment instruments for each core domain). For pressure ulcer prevention trials a COS is lacking. The great heterogeneity of reported outcomes in this field indicates the need for a COS. Methods/design The first part of this project aims to develop a core domain set by following established methods, which incorporates four steps: (1) definition of the scope, (2) conducting a scoping review, (3) organizing facilitated workshops with service users, (4) performing Delphi surveys and establishing consensus in a face-to-face meeting with different stakeholders. Discussion After achieving consensus on the core domain set, further work will be undertaken to determine a corresponding core measurement set. This will lead to better pressure ulcer prevention research in the future. There are a number of methodological challenges in the field of COS development. To meet these challenges and to ensure a high-quality COS, the OUTPUTS project affiliates to current standards and works in close collaboration with international experts and with existing international service user groups. Trial registration The OUTPUTs project is registered in the COMET database: (http://www.comet-initiative.org/studies/details/283). Registered on 2015. |
| first_indexed | 2024-12-22T13:23:24Z |
| format | Article |
| id | doaj.art-9a679cb1f0d145ed8ce38815980a27a3 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-22T13:23:24Z |
| publishDate | 2019-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-9a679cb1f0d145ed8ce38815980a27a32022-12-21T18:24:24ZengBMCTrials1745-62152019-07-012011910.1186/s13063-019-3543-9Outcomes for Pressure Ulcer Trials (OUTPUTs): protocol for the development of a core domain set for trials evaluating the clinical efficacy or effectiveness of pressure ulcer prevention interventionsAnna Lechner0Jan Kottner1Susanne Coleman2Delia Muir3Heather Bagley4Dimitri Beeckman5Wendy Chaboyer6Janet Cuddigan7Zena Moore8Claudia Rutherford9Jochen Schmitt10Jane Nixon11Katrin Balzer12Department of Dermatology and Allergy, Clinical Research Center for Hair and Skin Science, Charité – Universitätsmedizin BerlinDepartment of Dermatology and Allergy, Clinical Research Center for Hair and Skin Science, Charité – Universitätsmedizin BerlinInstitute of Clinical Trials Research, Clinical Trials Research Unit, University of LeedsInstitute of Clinical Trials Research, Clinical Trials Research Unit, University of LeedsClinical Trials Research Centre (CTRC), North West Hub for Trials Methodology, University of LiverpoolUniversity Centre for Nursing and Midwifery, Ghent UniversitySchool of Nursing & Midwifery, Menzies Health Institute Queensland, Griffith University and Gold Coast Hospital and Health ServiceCollege of Nursing, University of Nebraska Medical CenterRoyal College of Surgeons in IrelandFaculty of Science, Quality of Life Office, School of Psychology, University of SydneyCentre for Evidence-based Healthcare, Medical Faculty Carl Gustav Carus, Technical University DresdenInstitute of Clinical Trials Research, Clinical Trials Research Unit, University of LeedsInstitute of Clinical Trials Research, Clinical Trials Research Unit, University of LeedsAbstract Background Core outcome sets (COS) are being developed in many clinical areas to increase the quality and comparability of clinical trial results as well as to ensure their relevance for patients. A COS represents an agreed standardized set of outcomes that describes the minimum that should be consistently reported in all clinical trials of a defined area. It comprises a core domain set (defining what core outcomes should be measured) and a core measurement set (defining measurement/assessment instruments for each core domain). For pressure ulcer prevention trials a COS is lacking. The great heterogeneity of reported outcomes in this field indicates the need for a COS. Methods/design The first part of this project aims to develop a core domain set by following established methods, which incorporates four steps: (1) definition of the scope, (2) conducting a scoping review, (3) organizing facilitated workshops with service users, (4) performing Delphi surveys and establishing consensus in a face-to-face meeting with different stakeholders. Discussion After achieving consensus on the core domain set, further work will be undertaken to determine a corresponding core measurement set. This will lead to better pressure ulcer prevention research in the future. There are a number of methodological challenges in the field of COS development. To meet these challenges and to ensure a high-quality COS, the OUTPUTS project affiliates to current standards and works in close collaboration with international experts and with existing international service user groups. Trial registration The OUTPUTs project is registered in the COMET database: (http://www.comet-initiative.org/studies/details/283). Registered on 2015.http://link.springer.com/article/10.1186/s13063-019-3543-9Core domain setCore outcome setPressure ulcerPreventionScoping reviewDelphi |
| spellingShingle | Anna Lechner Jan Kottner Susanne Coleman Delia Muir Heather Bagley Dimitri Beeckman Wendy Chaboyer Janet Cuddigan Zena Moore Claudia Rutherford Jochen Schmitt Jane Nixon Katrin Balzer Outcomes for Pressure Ulcer Trials (OUTPUTs): protocol for the development of a core domain set for trials evaluating the clinical efficacy or effectiveness of pressure ulcer prevention interventions Trials Core domain set Core outcome set Pressure ulcer Prevention Scoping review Delphi |
| title | Outcomes for Pressure Ulcer Trials (OUTPUTs): protocol for the development of a core domain set for trials evaluating the clinical efficacy or effectiveness of pressure ulcer prevention interventions |
| title_full | Outcomes for Pressure Ulcer Trials (OUTPUTs): protocol for the development of a core domain set for trials evaluating the clinical efficacy or effectiveness of pressure ulcer prevention interventions |
| title_fullStr | Outcomes for Pressure Ulcer Trials (OUTPUTs): protocol for the development of a core domain set for trials evaluating the clinical efficacy or effectiveness of pressure ulcer prevention interventions |
| title_full_unstemmed | Outcomes for Pressure Ulcer Trials (OUTPUTs): protocol for the development of a core domain set for trials evaluating the clinical efficacy or effectiveness of pressure ulcer prevention interventions |
| title_short | Outcomes for Pressure Ulcer Trials (OUTPUTs): protocol for the development of a core domain set for trials evaluating the clinical efficacy or effectiveness of pressure ulcer prevention interventions |
| title_sort | outcomes for pressure ulcer trials outputs protocol for the development of a core domain set for trials evaluating the clinical efficacy or effectiveness of pressure ulcer prevention interventions |
| topic | Core domain set Core outcome set Pressure ulcer Prevention Scoping review Delphi |
| url | http://link.springer.com/article/10.1186/s13063-019-3543-9 |
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