Evidence map›Paper›PMID 35933433›Full record

SynthesisCritical care (London, England)2022

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 and 21 more

Registry-linked trialOpen access · goldAbstract readSystematic ReviewConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Critical care (London, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05531305 (Longitudinal Changes in Muscle Mass After Intensive Care), which is not on this map. Cited by 34 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 5 pooled it
28.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05531305 nacompletednot on this map

Longitudinal Changes in Muscle Mass After Intensive Care: a Pilot Feasibility Study.

TypeinterventionalSponsorKarolinska University HospitalRan2022 to 2023Enrolled35ConditionsCritical Illness, Muscle LossArmsMuscle ultrasound, Indirect calorimetry, Hand dynamometry, MRC Sum Score
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 5 syntheses or guidelines pooled it, 77 citations in OpenAlex.

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  11. Core outcome sets and trials of nutrition and metabolism interventions.Current opinion in clinical nutrition and metabolic care · 2026
    Review
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  14. Observational
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  16. Physical Activity Monitoring in Children in the 1-Year After 3 or More Days of Invasive Ventilation: Feasibility of Using Accelerometers.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

31 authors at 20 institutions in 14 countries.

T W DaviesWilliam Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
R J J van GasselDepartment of Intensive Care Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre+, Maastricht, The Netherlands.
M van de PollDepartment of Intensive Care Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre+, Maastricht, The Netherlands.
J GunstClinical Department and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.
M P CasaerClinical Department and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.
K B ChristopherDivision of Renal Medicine, Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, USA.
J C PreiserMedical Direction, Erasme University Hospital, Universite Libre de Bruxelles, Brussels, Belgium.
A HillDepartments of Intensive Care and Anesthesiology, University Hospital RWTH Aachen University, 52074, Aachen, Germany.
K GundoganDivision of Intensive Care Medicine, Department of Internal Medicine, Erciyes University School of Medicine, Kayseri, Turkey.
A Reintam-BlaserDepartment of Anaesthesiology and Intensive Care, University of Tartu, Tartu, Estonia.
A F RousseauDepartment of Intensive Care, University Hospital of Liège, Liege, Belgium.
C HodgsonAustralian 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.
D M NeedhamOutcomes After Critical Illness and Surgery (OACIS) Research Group, Johns Hopkins University, Baltimore, MD, USA.
M CastroClinical Nutrition, Hospital Israelita Albert Einstein, Sao Paulo, Brazil.
S SchallerDepartment of Anesthesiology and Operative Intensive Care Medicine (CVK, CCM), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, Berlin Institute of Health, Berlin, Germany.
T McClellandWilliam Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
J J PilkingtonCentre for Bioscience, Manchester Metropolitan University, John Dalton Building, Chester Street, Manchester, UK.
C M SevinDepartment of Medicine, Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
P E WischmeyerDepartment of Anesthesiology, Duke University School of Medicine, DUMC, Box 3094 Mail # 41, 2301 Erwin Road, Durham, NC, 5692 HAFS27710, USA.
Z Y LeeDepartment of Anesthesiology, University of Malaya, Kuala Lumpur, Malaysia.
D GovilInstitute of Critical Care and Anesthesia, Medanta: The Medicty, Gurugram, Haryana, India.
A LiDivision of Respiratory and Critical Care Medicine, Department of Medicine, National University Hospital, National University Health System, Singapore, Singapore.
L ChappleAdelaide Medical School, Faculty of Health and Medical Sciences, The University of Adelaide, Adelaide, SA, Australia.
L DenehyThe University of Melbourne, School of Health Sciences, Melbourne, Australia.
J C Montejo-GonzálezDepartment of Intensive Care Medicine, Hospital Universitario 12 de Octubre, Madrid, Spain.
B TaylorDepartment of Research for Patient Care Services, Barnes-Jewish Hospital, St. Louis, MO, USA.
D E BearDepartment of Critical Care and Department of Nutrition and Dietetics, Guy´S and St Thomas' NHS Foundation Trust, London, UK.
R PearseWilliam Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
A McNellyWilliam Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
J ProwleWilliam Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Z A PuthuchearyWilliam Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK. z.puthucheary@qmul.ac.uk.
William Harvey Research Institute · GBKU Leuven · BEMaastricht University Medical Centre · NLRoyal London Hospital · GBBarnes-Jewish Hospital · USBrigham and Women's Hospital · USCharité - Universitätsmedizin Berlin · DEDuke University · USErciyes University · TRGuy's and St Thomas' NHS Foundation Trust · GBHospital Israelita Albert Einstein · BRHospital Universitario 12 De Octubre · ESJohns Hopkins Medicine · USManchester Metropolitan University · GBMedanta The Medicity · INNational University Hospital · SGPeter MacCallum Cancer Centre · AUQueen Mary University of London · GBRWTH Aachen University · DEThe Alfred Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinical 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.

methodsAn 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.

resultsIn 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).

conclusionThe 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.

Indexed as

Activities of Daily LivingCritical IllnessAdultDelphi TechniqueHumansMultiple Organ FailureOutcome Assessment, Health CareResearch DesignTreatment OutcomeCore outcome setCritical illnessDelphiMetabolismNutrition

Identifiers

PMID35933433
PMCPMC9357332
OpenAlexW4290052798

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.