Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE)

T. W. Davies; R. J.J. van Gassel; M. van de Poll; J. Gunst; M. P. Casaer; K. B. Christopher; J. C. Preiser; A. Hill; K. Gundogan; A. Reintam-Blaser; A. F. Rousseau; C. Hodgson; D. M. Needham; M. Castro; S. Schaller; T. McClelland; J. J. Pilkington; C. M. Sevin; P. E. Wischmeyer; Z. Y. Lee; D. Govil; A. Li; L. Chapple; L. Denehy; J. C. Montejo-González; B. Taylor; D. E. Bear; R. Pearse; A. McNelly; J. Prowle; Z. A. Puthucheary

doi:10.1186/s13054-022-04113-x

Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE)

T. W. Davies, R. J.J. van Gassel, M. van de Poll, J. Gunst, M. P. Casaer, K. B. Christopher, J. C. Preiser, A. Hill, K. Gundogan, A. Reintam-Blaser, A. F. Rousseau, C. Hodgson, D. M. Needham, M. Castro, S. Schaller, T. McClelland, J. J. Pilkington, C. M. Sevin, P. E. Wischmeyer, Z. Y. LeeD. Govil, A. Li, L. Chapple, L. Denehy, J. C. Montejo-González, B. Taylor, D. E. Bear, R. Pearse, A. McNelly, J. Prowle, Z. A. Puthucheary

School of Medicine

Research output: Contribution to journal › Article › peer-review

Abstract

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.

Original language	English (US)
Article number	240
Journal	Critical Care
Volume	26
Issue number	1
DOIs	https://doi.org/10.1186/s13054-022-04113-x
State	Published - Dec 2022

Keywords

Core outcome set
Critical illness
Delphi
Metabolism
Nutrition

ASJC Scopus subject areas

Critical Care and Intensive Care Medicine

Access to Document

10.1186/s13054-022-04113-x

Cite this

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., ... Puthucheary, Z. A. (2022). Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE). Critical Care, 26(1), Article 240. https://doi.org/10.1186/s13054-022-04113-x

Davies, TW, van Gassel, RJJ, van de Poll, M, Gunst, J, Casaer, MP, Christopher, KB, Preiser, JC, Hill, A, Gundogan, K, Reintam-Blaser, A, Rousseau, AF, Hodgson, C, Needham, DM, Castro, M, Schaller, S, McClelland, T, Pilkington, JJ, Sevin, CM, Wischmeyer, PE, Lee, ZY, Govil, D, Li, A, Chapple, L, Denehy, L, Montejo-González, JC, Taylor, B, Bear, DE, Pearse, R, McNelly, A, Prowle, J & Puthucheary, ZA 2022, 'Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE)', Critical Care, vol. 26, no. 1, 240. https://doi.org/10.1186/s13054-022-04113-x

@article{3b1b0cc68b844130b3b7ba9687f0dec9,

title = "Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE)",

abstract = "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 {\textquoteleft}essential{\textquoteright} 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 {\textquoteleft}essential{\textquoteright} 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 {\textquoteleft}essential{\textquoteright} measurement instruments reached consensus for survival and activities of daily living, and {\textquoteleft}recommended{\textquoteright} 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 {\textquoteleft}recommended,{\textquoteright} but not {\textquoteleft}essential,{\textquoteright} 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.",

keywords = "Core outcome set, Critical illness, Delphi, Metabolism, Nutrition",

author = "Davies, {T. W.} and {van Gassel}, {R. J.J.} and {van de Poll}, M. and J. Gunst and Casaer, {M. P.} and Christopher, {K. B.} and Preiser, {J. C.} and A. Hill and K. Gundogan and A. Reintam-Blaser and Rousseau, {A. F.} and C. Hodgson and Needham, {D. M.} and M. Castro and S. Schaller and T. McClelland and Pilkington, {J. J.} and Sevin, {C. M.} and Wischmeyer, {P. E.} and Lee, {Z. Y.} and D. Govil and A. Li and L. Chapple and L. Denehy and Montejo-Gonz{\'a}lez, {J. C.} and B. Taylor and Bear, {D. E.} and R. Pearse and A. McNelly and J. Prowle and Puthucheary, {Z. A.}",

note = "Publisher Copyright: {\textcopyright} 2022, The Author(s).",

year = "2022",

month = dec,

doi = "10.1186/s13054-022-04113-x",

language = "English (US)",

volume = "26",

journal = "Critical Care",

issn = "1364-8535",

publisher = "BioMed Central",

number = "1",

}

TY - JOUR

T1 - Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness

T2 - an international modified Delphi consensus study evaluation (CONCISE)

AU - Davies, T. W.

AU - van Gassel, R. J.J.

AU - van de Poll, M.

AU - Gunst, J.

AU - Casaer, M. P.

AU - Christopher, K. B.

AU - Preiser, J. C.

AU - Hill, A.

AU - Gundogan, K.

AU - Reintam-Blaser, A.

AU - Rousseau, A. F.

AU - Hodgson, C.

AU - Needham, D. M.

AU - Castro, M.

AU - Schaller, S.

AU - McClelland, T.

AU - Pilkington, J. J.

AU - Sevin, C. M.

AU - Wischmeyer, P. E.

AU - Lee, Z. Y.

AU - Govil, D.

AU - Li, A.

AU - Chapple, L.

AU - Denehy, L.

AU - Montejo-González, J. C.

AU - Taylor, B.

AU - Bear, D. E.

AU - Pearse, R.

AU - McNelly, A.

AU - Prowle, J.

AU - Puthucheary, Z. A.

PY - 2022/12

Y1 - 2022/12

N2 - 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.

AB - 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.

KW - Core outcome set

KW - Critical illness

KW - Delphi

KW - Metabolism

KW - Nutrition

UR - http://www.scopus.com/inward/record.url?scp=85135457615&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85135457615&partnerID=8YFLogxK

U2 - 10.1186/s13054-022-04113-x

DO - 10.1186/s13054-022-04113-x

M3 - Article

C2 - 35933433

AN - SCOPUS:85135457615

SN - 1364-8535

VL - 26

JO - Critical Care

JF - Critical Care

IS - 1

M1 - 240

ER -

Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE)

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this