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Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE)
BACKGROUND: Clinical research on nutritional and metabolic interventions in critically ill patients is heterogenous regarding time points, outcomes and measurement instruments used, impeding intervention development and data syntheses, and ultimately worsening clinical outcomes. We aimed to identify...
| Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
BioMed Central
2022
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9357332/ https://www.ncbi.nlm.nih.gov/pubmed/35933433 http://dx.doi.org/10.1186/s13054-022-04113-x |
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| author | Davies, T. W. van Gassel, R. J. J. van de Poll, M. Gunst, J. Casaer, M. P. Christopher, K. B. Preiser, J. C. Hill, A. Gundogan, K. Reintam-Blaser, A. Rousseau, A. F. Hodgson, C. Needham, D. M. Castro, M. Schaller, S. McClelland, T. Pilkington, J. J. Sevin, C. M. Wischmeyer, P. E. Lee, Z. Y. Govil, D. Li, A. Chapple, L. Denehy, L. Montejo-González, J. C. Taylor, B. Bear, D. E. Pearse, R. McNelly, A. Prowle, J. Puthucheary, Z. A. |
| author_facet | Davies, T. W. van Gassel, R. J. J. van de Poll, M. Gunst, J. Casaer, M. P. Christopher, K. B. Preiser, J. C. Hill, A. Gundogan, K. Reintam-Blaser, A. Rousseau, A. F. Hodgson, C. Needham, D. M. Castro, M. Schaller, S. McClelland, T. Pilkington, J. J. Sevin, C. M. Wischmeyer, P. E. Lee, Z. Y. Govil, D. Li, A. Chapple, L. Denehy, L. Montejo-González, J. C. Taylor, B. Bear, D. E. Pearse, R. McNelly, A. Prowle, J. Puthucheary, Z. A. |
| author_sort | Davies, T. W. |
| collection | PubMed |
| description | BACKGROUND: Clinical research on nutritional and metabolic interventions in critically ill patients is heterogenous regarding time points, outcomes and measurement instruments used, impeding intervention development and data syntheses, and ultimately worsening clinical outcomes. We aimed to identify and develop a set of core outcome domains and associated measurement instruments to include in all research in critically ill patients. METHODS: An updated systematic review informed a two-stage modified Delphi consensus process (domains followed by instruments). Measurement instruments for domains considered ‘essential’ were taken through the second stage of the Delphi and a subsequent consensus meeting. RESULTS: In total, 213 participants (41 patients/caregivers, 50 clinical researchers and 122 healthcare professionals) from 24 countries contributed. Consensus was reached on time points (30 and 90 days post-randomisation). Three domains were considered ‘essential’ at 30 days (survival, physical function and Infection) and five at 90 days (survival, physical function, activities of daily living, nutritional status and muscle/nerve function). Core ‘essential’ measurement instruments reached consensus for survival and activities of daily living, and ‘recommended’ measurement instruments for physical function, nutritional status and muscle/nerve function. No consensus was reached for a measurement instrument for Infection. Four further domains met criteria for ‘recommended,’ but not ‘essential,’ to measure at 30 days post-randomisation (organ dysfunction, muscle/nerve function, nutritional status and wound healing) and three at 90 days (frailty, body composition and organ dysfunction). CONCLUSION: The CONCISE core outcome set is an internationally agreed minimum set of outcomes for use at 30 and 90 days post-randomisation, in nutritional and metabolic clinical research in critically ill adults. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13054-022-04113-x. |
| format | Online Article Text |
| id | pubmed-9357332 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2022 |
| publisher | BioMed Central |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-93573322022-08-08 Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE) Davies, T. W. van Gassel, R. J. J. van de Poll, M. Gunst, J. Casaer, M. P. Christopher, K. B. Preiser, J. C. Hill, A. Gundogan, K. Reintam-Blaser, A. Rousseau, A. F. Hodgson, C. Needham, D. M. Castro, M. Schaller, S. McClelland, T. Pilkington, J. J. Sevin, C. M. Wischmeyer, P. E. Lee, Z. Y. Govil, D. Li, A. Chapple, L. Denehy, L. Montejo-González, J. C. Taylor, B. Bear, D. E. Pearse, R. McNelly, A. Prowle, J. Puthucheary, Z. A. Crit Care Research BACKGROUND: Clinical research on nutritional and metabolic interventions in critically ill patients is heterogenous regarding time points, outcomes and measurement instruments used, impeding intervention development and data syntheses, and ultimately worsening clinical outcomes. We aimed to identify and develop a set of core outcome domains and associated measurement instruments to include in all research in critically ill patients. METHODS: An updated systematic review informed a two-stage modified Delphi consensus process (domains followed by instruments). Measurement instruments for domains considered ‘essential’ were taken through the second stage of the Delphi and a subsequent consensus meeting. RESULTS: In total, 213 participants (41 patients/caregivers, 50 clinical researchers and 122 healthcare professionals) from 24 countries contributed. Consensus was reached on time points (30 and 90 days post-randomisation). Three domains were considered ‘essential’ at 30 days (survival, physical function and Infection) and five at 90 days (survival, physical function, activities of daily living, nutritional status and muscle/nerve function). Core ‘essential’ measurement instruments reached consensus for survival and activities of daily living, and ‘recommended’ measurement instruments for physical function, nutritional status and muscle/nerve function. No consensus was reached for a measurement instrument for Infection. Four further domains met criteria for ‘recommended,’ but not ‘essential,’ to measure at 30 days post-randomisation (organ dysfunction, muscle/nerve function, nutritional status and wound healing) and three at 90 days (frailty, body composition and organ dysfunction). CONCLUSION: The CONCISE core outcome set is an internationally agreed minimum set of outcomes for use at 30 and 90 days post-randomisation, in nutritional and metabolic clinical research in critically ill adults. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13054-022-04113-x. BioMed Central 2022-08-06 /pmc/articles/PMC9357332/ /pubmed/35933433 http://dx.doi.org/10.1186/s13054-022-04113-x Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
| spellingShingle | Research Davies, T. W. van Gassel, R. J. J. van de Poll, M. Gunst, J. Casaer, M. P. Christopher, K. B. Preiser, J. C. Hill, A. Gundogan, K. Reintam-Blaser, A. Rousseau, A. F. Hodgson, C. Needham, D. M. Castro, M. Schaller, S. McClelland, T. Pilkington, J. J. Sevin, C. M. Wischmeyer, P. E. Lee, Z. Y. Govil, D. Li, A. Chapple, L. Denehy, L. Montejo-González, J. C. Taylor, B. Bear, D. E. Pearse, R. McNelly, A. Prowle, J. Puthucheary, Z. A. Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE) |
| title | Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE) |
| title_full | Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE) |
| title_fullStr | Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE) |
| title_full_unstemmed | Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE) |
| title_short | Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE) |
| title_sort | core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified delphi consensus study evaluation (concise) |
| topic | Research |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9357332/ https://www.ncbi.nlm.nih.gov/pubmed/35933433 http://dx.doi.org/10.1186/s13054-022-04113-x |
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