A systematic review and meta-analysis of the clinimetric properties of the core outcome measurement instruments for clinical effectiveness trials of nutritional and metabolic interventions in critical illness (CONCISE)

Davies TW 1 , Kelly E 2 , van Gassel RJJ 3 , van de Poll MCG 3 , Gunst J 4 , Casaer MP 4 Show all authors , Christopher KB 5 , Preiser JC 6 , Hill A 7 , Gundogan K 8 , Reintam-Blaser A 9 , Rousseau AF 10 , Hodgson C 11 , Needham DM 12 , Schaller SJ 13 , McClelland T 2 , Pilkington JJ 14 , Sevin CM 15 , Wischmeyer PE 16 , Lee ZY 17 , Govil D 18 , Chapple L 19 , Denehy L 20 , Montejo-González JC 21 , Taylor B 22 , Bear DE 23 , Pearse RM 2 , McNelly A 2 , Prowle J 2 , Puthucheary ZA 2

Affiliations 

  • 1 Faculty of Medicine & Dentistry, Queen Mary University of London, London, EC1M 6BQ, UK. thomas.davies6@nhs.net
  • 2 Faculty of Medicine & Dentistry, Queen Mary University of London, London, EC1M 6BQ, UK
  • 3 Department of Intensive Care Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre+, Maastricht, The Netherlands
  • 4 Clinical Department and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, 3000, Louvain, Belgium
  • 5 Division of Renal Medicine, Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, MA, USA
  • 6 Medical Direction, Erasme University Hospital, Universite Libre de Bruxelles, Brussels, Belgium
  • 7 Department of Intensive Care Medicine, University Hospital RWTH, 52074, Aachen, Germany
  • 8 Division of Intensive Care Medicine, Department of Internal Medicine, Erciyes University School of Medicine, Kayseri, Turkey
  • 9 Department of Anaesthesiology and Intensive Care, University of Tartu, Tartu, Estonia
  • 10 Department of Intensive Care, University Hospital of Liège, Liege, Belgium
  • 11 Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, 3/553 St Kilda Rd, Melbourne, VIC, 3004, Australia
  • 12 Outcomes After Critical Illness and Surgery (OACIS) Research Group, Johns Hopkins University, Baltimore, MD, USA
  • 13 Department of Anesthesiology and Intensive Care Medicine (CVK, CCM), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, Berlin Institute of Health, Berlin, Germany
  • 14 Centre for Bioscience, Manchester Metropolitan University, John Dalton Building, Chester Street, Manchester, UK
  • 15 Department of Medicine, Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA
  • 16 Department of Anesthesiology, Duke University School of Medicine, DUMC, Box 3094 Mail # 41, 2301 Erwin Road, Durham, NC, 5692 HAFS27710, USA
  • 17 Department of Anesthesiology, University of Malaya, Kuala Lumpur, Malaysia
  • 18 Institute of Critical Care and Anesthesia, Medanta: The Medicty, Gurugram, Haryana, India
  • 19 Adelaide Medical School, Faculty of Health and Medical Sciences, The University of Adelaide, Adelaide, SA, Australia
  • 20 School of Health Sciences, The University of Melbourne, Melbourne, Australia
  • 21 Instituto de Investigación I+12, Hospital Universitario, 12 de Octubre, Madrid, Spain
  • 22 Department of Research for Patient Care Services, Barnes-Jewish Hospital, St. Louis, MO, USA
  • 23 Department of Critical Care, Guy's and St Thomas' NHS Foundation Trust, London, UK
Crit Care, 2023 Nov 20;27(1):450.
PMID: 37986015 DOI: 10.1186/s13054-023-04729-7

Abstract

BACKGROUND: CONCISE is an internationally agreed minimum set of outcomes for use in nutritional and metabolic clinical research in critically ill adults. Clinicians and researchers need to be aware of the clinimetric properties of these instruments and understand any limitations to ensure valid and reliable research. This systematic review and meta-analysis were undertaken to evaluate the clinimetric properties of the measurement instruments identified in CONCISE.

METHODS: Four electronic databases were searched from inception to December 2022 (MEDLINE via Ovid, EMBASE via Ovid, CINAHL via Healthcare Databases Advanced Search, CENTRAL via Cochrane). Studies were included if they examined at least one clinimetric property of a CONCISE measurement instrument or recognised variation in adults ≥ 18 years with critical illness or recovering from critical illness in any language. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist for systematic reviews of Patient-Reported Outcome Measures was used. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses were used in line with COSMIN guidance. The COSMIN checklist was used to evaluate the risk of bias and the quality of clinimetric properties. Overall certainty of the evidence was rated using a modified Grading of Recommendations, Assessment, Development and Evaluation approach. Narrative synthesis was performed and where possible, meta-analysis was conducted.

RESULTS: A total of 4316 studies were screened. Forty-seven were included in the review, reporting data for 12308 participants. The Short Form-36 Questionnaire (Physical Component Score and Physical Functioning), sit-to-stand test, 6-m walk test and Barthel Index had the strongest clinimetric properties and certainty of evidence. The Short Physical Performance Battery, Katz Index and handgrip strength had less favourable results. There was limited data for Lawson Instrumental Activities of Daily Living and the Global Leadership Initiative on Malnutrition criteria. The risk of bias ranged from inadequate to very good. The certainty of the evidence ranged from very low to high.

CONCLUSIONS: Variable evidence exists to support the clinimetric properties of the CONCISE measurement instruments. We suggest using this review alongside CONCISE to guide outcome selection for future trials of nutrition and metabolic interventions in critical illness.

TRIAL REGISTRATION:  PROSPERO (CRD42023438187). Registered 21/06/2023.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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