International development and implementation of a core measurement set for research and audit studies in implant-based breast reconstruction: a study protocol
| Autor: | Sherif Wilson, Yazan Masannat, Joerg Heil, Joanna Skillman, Kerry N L Avery, Shelley Potter, Walter P. Weber, Charlotte F Davies, Steven Thrush, Lisa Whisker, Chris Metcalfe, Eva Weiler-Mithoff, Jane M Blazeby, Christopher Holcombe, Raghavan Vidya |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Consensus Delphi Technique Endpoint Determination Breast Implants Mammaplasty Delphi method Audit breast tumours BTC (Bristol Trials Centre) Outcome (game theory) Face-to-face Outcome Assessment Health Care Medicine Humans Medical physics computer.programming_language Protocol (science) Research ethics Clinical Audit business.industry General Medicine breast surgery plastic & reconstructive surgery Systematic review Surgery Female business computer Delphi |
| Zdroj: | BMJ Open Potter, S, Davies, C, Holcombe, C, Weiler Mithoff, E, Skillman, J, Vidya, R, Masannat, Y, Weber, W, Heil, J, Wilson, S, Thrush, S, Whisker, L, Blazeby, J, Metcalfe, C & Avery, K 2020, ' International development and implementation of a core measurement set for research and audit studies in implant-based breast reconstruction : A study protocol ', BMJ Open, vol. 10, no. 1, e035505 . https://doi.org/10.1136/bmjopen-2019-035505 |
| ISSN: | 2044-6055 |
| Popis: | IntroductionOutcome reporting in research studies of breast reconstruction is inconsistent and lacks standardisation. The results of individual studies therefore cannot be meaningfully compared or combined limiting their value. A core outcome set (COS) has been developed to address these issues and identified 11 key outcomes to be measured and reported in all future research and audit studies in reconstructive breast surgery (RBS). A COS represents what key outcomes should be measured. The next step is to determine how and when this should be done. The aim of this study is to develop a core measurement set (CMS) for use in research and audit studies in implant-based breast reconstruction.Methods and analysisThe CMS will be developed in accordance with the guidance developed by the Core Outcome Measures in Effectiveness Trials initiative (COMET) and COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) group for the selection of outcome measurement instruments (OMIs) for relevant outcome domains included in the RBS COS. This will involve three phases with strategies to promote implementation as a final additional phase. The phases are (1) conceptual considerations in which the target population, procedures and settings are defined; (2) systematic reviews to identify existing clinical, patient-reported and cosmetic OMIs and, if appropriate, assess their quality using COSMIN methodology; (3) a modified Delphi process including sequential Delphi surveys involving approximately 100 healthcare professionals and a face to face consensus meeting to agree and ratify which outcome definitions and OMIs should be used and standardised time points for assessment; (4) strategies to promote dissemination and adoption of the CMS.Ethics and disseminationEthical approval has been granted by University of Bristol Faculty Research Ethics Committee FREC ID 60221. Dissemination strategies will include scientific meeting presentations and peer-reviewed journal publications. Implementation activities will include engagement with journal editors and funders to promote uptake and use of the CMS. |
| Databáze: | OpenAIRE |
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