Evidence-based personalised medicine in critical care: a framework for quantifying and applying individualised treatment effects in patients who are critically ill

Elizabeth S Munroe¹, Alexandra Spicer², Andrea Castellvi-Font³, Ann Zalucky⁴, Jose Dianti⁵, Emma Graham Linck⁶, Victor Talisa⁷, Martin Urner⁸, Derek C Angus⁷, Elias Baedorf-Kassis⁹, Bryan Blette¹⁰, Lieuwe D Bos¹¹, Kevin G Buell¹², Jonathan D Casey¹³, Carolyn S Calfee¹⁴, Lorenzo Del Sorbo¹⁵, Elisa Estenssoro¹⁶, Niall D Ferguson¹⁷, Rachel Giblon¹⁸, Anders Granholm¹⁹, Michael O Harhay²⁰, Anna Heath¹⁸, Carol Hodgson²¹, Timothy Houle²², Cong Jiang²³, Lina Kramer¹¹, Patrick R Lawler²⁴, Aleksandra Leligdowicz²⁵, Fan Li²⁶, Kuan Liu²⁷, Amelia Maiga²⁸, David Maslove²⁹, Colin McArthur³⁰, Daniel F McAuley³¹, Ary Serpa Neto³², Charissa Oosthuysen¹⁵, Anders Perner¹⁹, Hallie C Prescott³³, Bram Rochwerg³⁴, Sarina Sahetya³⁵, Mariia Samoilenko²³, Mireille E Schnitzer³⁶, Kevin P Seitz¹³, Faraaz Shah³⁷, Manu Shankar-Hari³⁸, Pratik Sinha³⁹, Arthur S Slutsky⁴⁰, Edward T Qian¹³, Steve A Webb²¹, Paul J Young⁴¹, Fernando G Zampieri⁴², Ryan Zarychanski⁴³, Eddy Fan¹⁷, Matthew W Semler¹³, Matthew Churpek⁴⁴, Ewan C Goligher⁴⁵; Platform of Randomized Adaptive Clinical Trials in Critical Illness (PRACTICAL) investigators; Evidence-based Individualized Treatment Effects (EvITE) Group

Affiliations

¹ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
² Division of Pulmonary and Critical Care, Department of Medicine, University of Wisconsin-Madison, Madison, WI, USA.
³ Department of Critical Care, Hospital del Mar, and Critical Illness Research Group (GREPAC), Hospital del Mar Research Institute (IMIM), Barcelona, Spain; Division of Respirology, Department of Medicine, University Health Network, Toronto, ON, Canada; Toronto General Hospital Research Institute, Toronto, ON, Canada.
⁴ Department of Critical Care Medicine, Snyder Institute for Chronic Diseases, Cumming School of Medicine, University of Calgary and Alberta Health Services, Foothills Medical Center, Calgary, AB, Canada; Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, University of California San Francisco, San Francisco, CA, USA.
⁵ Division of Respirology, Department of Medicine, University Health Network, Toronto, ON, Canada; Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
⁶ School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.
⁷ Center for Reasearch, Investigation, and Systems Modeling of Acute Illness, Department of Critical Care Medicine, University of Pittsburgh, PA, USA.
⁸ Toronto General Hospital Research Institute, Toronto, ON, Canada; Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada; Department of Anesthesiology & Pain Medicine, University of Toronto, Toronto, ON, Canada.
⁹ Department of Medicine, Harvard Medical School, Boston, MA, USA.
¹⁰ Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
¹¹ Department of Intensive Care and Laboratory of Experimental Intensive Care and Anesthesiology, Amsterdam, Netherlands.
¹² Division of Pulmonary and Critical Care, Department of Medicine, University of Chicago, Chicago, IL, USA.
¹³ Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
¹⁴ Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, University of California San Francisco, San Francisco, CA, USA.
¹⁵ Division of Respirology, Department of Medicine, University Health Network, Toronto, ON, Canada.
¹⁶ Hospital Interzonal San Martin de La Plata, Buenos Aires, Argentina.
¹⁷ Division of Respirology, Department of Medicine, University Health Network, Toronto, ON, Canada; Toronto General Hospital Research Institute, Toronto, ON, Canada; Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
¹⁸ Division of Biostatistics, University of Toronto, Toronto, ON, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
¹⁹ Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
²⁰ Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
²¹ Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.
²² Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
²³ Faculté of Pharmacie, Université de Montréal, Montreal, QC, Canada.
²⁴ Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada; Division of Cardiology, Department of Medicine, McGill University Health Centre, Montreal, QC, Canada.
²⁵ Division of Critial Care Medicine, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
²⁶ Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.
²⁷ Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, ON, Canada.
²⁸ Division of Acute Care Surgery, Department of Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.
²⁹ Department of Critical Care Medicine, Queen's University, Kingston, ON, Canada.
³⁰ Department of Critical Care Medicine, Te Toka Tumai Auckland City Hospital, Auckland, New Zealand.
³¹ Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, Northern Ireland.
³² Department of Intensive Care, Austin Hospital, Melbourne, VIC, Australia; Department of Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paolo, Brazil; Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.
³³ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA; VA Center for Clinical Management Research, Ann Arbor, MI, USA.
³⁴ Department of Medicine, McMaster University, Hamilton, ON, Canada.
³⁵ Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
³⁶ Faculté of Pharmacie, Université de Montréal, Montreal, QC, Canada; Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal, QC, Canada.
³⁷ Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
³⁸ Centre for Inflammation Research, Institute for Regeneration and Repair, The University of Edinburgh, Edinburgh, UK.
³⁹ Department of Anesthesiology, Washington University School of Medicine in St Louis, St Louis, MO, USA.
⁴⁰ Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
⁴¹ Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia; Intensive Care Unit, Wellington Hospital, Wellington, New Zealand; Medical Research Institute of New Zealand, Wellington, New Zealand; Department of Critical Care, University of Melbourne, Melbourne, VIC, Australia.
⁴² Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton, AB, Canada.
⁴³ Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.
⁴⁴ Division of Pulmonary and Critical Care, Department of Medicine, University of Wisconsin-Madison, Madison, WI, USA; School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.
⁴⁵ Division of Respirology, Department of Medicine, University Health Network, Toronto, ON, Canada; Toronto General Hospital Research Institute, Toronto, ON, Canada; Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada. Electronic address: ewan.goligher@utoronto.ca.

PMID: 40250459
PMCID: PMC12362495 (available on 2026-04-15)
DOI: 10.1016/S2213-2600(25)00054-2

Review

Evidence-based personalised medicine in critical care: a framework for quantifying and applying individualised treatment effects in patients who are critically ill

Elizabeth S Munroe et al. Lancet Respir Med. 2025 Jun.

. 2025 Jun;13(6):556-568.

doi: 10.1016/S2213-2600(25)00054-2. Epub 2025 Apr 15.

Authors

Affiliations

¹ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
² Division of Pulmonary and Critical Care, Department of Medicine, University of Wisconsin-Madison, Madison, WI, USA.
³ Department of Critical Care, Hospital del Mar, and Critical Illness Research Group (GREPAC), Hospital del Mar Research Institute (IMIM), Barcelona, Spain; Division of Respirology, Department of Medicine, University Health Network, Toronto, ON, Canada; Toronto General Hospital Research Institute, Toronto, ON, Canada.
⁴ Department of Critical Care Medicine, Snyder Institute for Chronic Diseases, Cumming School of Medicine, University of Calgary and Alberta Health Services, Foothills Medical Center, Calgary, AB, Canada; Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, University of California San Francisco, San Francisco, CA, USA.
⁵ Division of Respirology, Department of Medicine, University Health Network, Toronto, ON, Canada; Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
⁶ School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.
⁷ Center for Reasearch, Investigation, and Systems Modeling of Acute Illness, Department of Critical Care Medicine, University of Pittsburgh, PA, USA.
⁸ Toronto General Hospital Research Institute, Toronto, ON, Canada; Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada; Department of Anesthesiology & Pain Medicine, University of Toronto, Toronto, ON, Canada.
⁹ Department of Medicine, Harvard Medical School, Boston, MA, USA.
¹⁰ Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
¹¹ Department of Intensive Care and Laboratory of Experimental Intensive Care and Anesthesiology, Amsterdam, Netherlands.
¹² Division of Pulmonary and Critical Care, Department of Medicine, University of Chicago, Chicago, IL, USA.
¹³ Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
¹⁴ Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, University of California San Francisco, San Francisco, CA, USA.
¹⁵ Division of Respirology, Department of Medicine, University Health Network, Toronto, ON, Canada.
¹⁶ Hospital Interzonal San Martin de La Plata, Buenos Aires, Argentina.
¹⁷ Division of Respirology, Department of Medicine, University Health Network, Toronto, ON, Canada; Toronto General Hospital Research Institute, Toronto, ON, Canada; Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
¹⁸ Division of Biostatistics, University of Toronto, Toronto, ON, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
¹⁹ Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
²⁰ Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
²¹ Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.
²² Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
²³ Faculté of Pharmacie, Université de Montréal, Montreal, QC, Canada.
²⁴ Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada; Division of Cardiology, Department of Medicine, McGill University Health Centre, Montreal, QC, Canada.
²⁵ Division of Critial Care Medicine, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
²⁶ Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.
²⁷ Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, ON, Canada.
²⁸ Division of Acute Care Surgery, Department of Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.
²⁹ Department of Critical Care Medicine, Queen's University, Kingston, ON, Canada.
³⁰ Department of Critical Care Medicine, Te Toka Tumai Auckland City Hospital, Auckland, New Zealand.
³¹ Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, Northern Ireland.
³² Department of Intensive Care, Austin Hospital, Melbourne, VIC, Australia; Department of Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paolo, Brazil; Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.
³³ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA; VA Center for Clinical Management Research, Ann Arbor, MI, USA.
³⁴ Department of Medicine, McMaster University, Hamilton, ON, Canada.
³⁵ Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
³⁶ Faculté of Pharmacie, Université de Montréal, Montreal, QC, Canada; Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal, QC, Canada.
³⁷ Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
³⁸ Centre for Inflammation Research, Institute for Regeneration and Repair, The University of Edinburgh, Edinburgh, UK.
³⁹ Department of Anesthesiology, Washington University School of Medicine in St Louis, St Louis, MO, USA.
⁴⁰ Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
⁴¹ Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia; Intensive Care Unit, Wellington Hospital, Wellington, New Zealand; Medical Research Institute of New Zealand, Wellington, New Zealand; Department of Critical Care, University of Melbourne, Melbourne, VIC, Australia.
⁴² Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton, AB, Canada.
⁴³ Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.
⁴⁴ Division of Pulmonary and Critical Care, Department of Medicine, University of Wisconsin-Madison, Madison, WI, USA; School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.
⁴⁵ Division of Respirology, Department of Medicine, University Health Network, Toronto, ON, Canada; Toronto General Hospital Research Institute, Toronto, ON, Canada; Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada. Electronic address: ewan.goligher@utoronto.ca.

PMID: 40250459
PMCID: PMC12362495 (available on 2026-04-15)
DOI: 10.1016/S2213-2600(25)00054-2

Abstract

Clinicians aim to provide treatments that will result in the best outcome for each patient. Ideally, treatment decisions are based on evidence from randomised clinical trials. Randomised trials conventionally report an aggregated difference in outcomes between patients in each group, known as an average treatment effect. However, the actual effect of treatment on outcomes (treatment response) can vary considerably between individuals, and can differ substantially from the average treatment effect. This variation in response to treatment between patients-heterogeneity of treatment effect-is particularly important in critical care because common critical care syndromes (eg, sepsis and acute respiratory distress syndrome) are clinically and biologically heterogeneous. Statistical approaches have been developed to analyse heterogeneity of treatment effect and predict individualised treatment effects for each patient. In this Review, we outline a framework for deriving and validating individualised treatment effects and identify challenges to applying individualised treatment effect estimates to inform treatment decisions in clinical care.

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Conflict of interest statement

Declaration of interests ESM reports grant funding from the US National Institutes of Health (NIH; grant numbers T32HL007749, F32HL172463, and L30HL170379). AS reports grants through her institution from NIH (National Heart, Lung, and Blood Institute [NHLBI] grant number R01HL157262-02 and National Institute of General Medical Sciences [NIGMS] grant number R01GM123193) and US Department of Defense (DOD; grant number PRMRP W81XWH-21-1-0009). EGL received grant funding from NIH (grant numbers T155T15LM007359 and NHLBI R01HL157262). MU received funding from the Canadian Institutes of Health Research (CIHR) and the Interdepartmental Division of Critical Care Medicine at the University of Toronto (ON, Canada). DCA received grant funding from NIH (grant number NIGMS R01GM141081); and personal fees from Abionyx, AM-Pharma, Bayer, Inotrem, and Spectral. VT, DCA, and FS receive grant funding from NIH (grant number R01GM141081). LDB reports being on the advisory board of Sobi NL, Impentri, Novartis, AstraZeneca, and CSL Behring; received grant funding (via institution) from Volition and Santhera; received grant funding from Longfonds, Innovative Medicine Initiative, Amsterdam University Medical Center, Health Holland via Longfond, and ZonMw; and received personal fees (via institution) from Scailyte. KGB received grant funding from NIH–NHLBI (grant number T32HL007605). CSC is a council member of the International Sepsis Forum; reports grants through her institution from NIH, Roche Genentech, and Quantum Leap Healthcare; received personal fees from Vasomune, Gen1e Life Sciences, NGM Bio, Cellenkos, Calcimedica, Arrowhead, EnliTISA, and Novartis; has a patent on metagenomic sequencing for sepsis diagnosis issued through the Regents of the University of California (CA, USA) and Chan Zuckerberg BioHub; and was supported by an NHLBI grant (R35HL140026). LDS reports grant funding through his institution from the Canadian Mount Sinai Hospital University Health Network Academic Medical Organization Innovation Fund and CIHR; and has applied for a patent for biomarkers for detecting of outcome or risk of patients with a respiratory illness. AG received grant funding through his institution from Sygeforsikringen “danmark”, the Novo Nordisk Foundation, and the Independent Research Fund Denmark for other projects. AH reports grant funding as Canada Research Chair in Statistical Design and from the Natural Sciences and Engineering Research Council of Canada. MOH received grant funding from NIH (grant numbers U01HL168419 and R01HL168202); and personal fees from Elsevier, the American Thoracic Society, Unlearn.AI, and Guidepoint. CJ reports grant funding from the CIHR; and a postdoctoral fellowship awarded by the StatLab at the Centre de Recherches Mathématique. PRL received financial support from the Fonds de Recherche de Quebec. FL reports grant funding from NIH–NHLBI (grant number R01HL168202) and the Patient-Centered Outcomes Research Institute (PCORI; ME-2020C3-21072, ME-2020C1-19220, and ME-2022C2-27676); and has received personal fees from PCORI as a consultant. AM reports grant funding from NIH (grant number 1K23GM150110) and the American College of Surgeons. DFM reports personal fees for consultancy for acute respiratory distress syndrome from GlaxoSmithKline, Boehringer Ingelheim, Novartis, Bayer, Aptarion, Direct Biologics, Eli Lilly, Sobi, and Aviceda; and personal fees for sitting on a data and safety monitoring board (DSMB) from Vir Biotechnology and Faron Pharmaceuticals; his institution has received funds from grants from the National Institute for Health and Care Research (NIHR), Wellcome Trust, UK Medical Research Council, Innovate UK, Randox, Novavax, and Northern Ireland Health and Social Care R&D Division, all unrelated to this work; has a patent (issued to institution) for a treatment for acute respiratory distress syndrome; and is NIHR Scientific Director for Research Programmes. AP received grant funding through his institution from the Novo Nordisk Foundation, Sygeforsikringen, and the Independent Research Fund Denmark. HCP reports being on the DSMB of the AID-ICU trial and SMARA trial; is co-chair of the Surviving Sepsis Campaign Guidelines; and received grants from the NIH–NHLBI, Agency for Healthcare Research and Quality, US Veterans Affairs, Blue Cross Blue Shield of Michigan, and US Centers for Disease Control and Prevention. ASS reports personal fees for speaking, or consultancy from Draeger Medical, Predicate, SafeBVM, SaNOtize, Sensory Cloud, and Stimit; sits on the Board of Thornhill Medical and De Motu Cordis; chairs the DSMBs of the PREVENT VILI (NIH-sponsored), RheSolve (Galvanize Therapeutics), and BREATHE-3 (Apreo Health) trials; and reports shares in Thornhill Medical, De Motu Cordis, Signal 1, SafeBVM, and Sensory Cloud. SS received grant funding through her institution from the NIH–NHLBI and DOD; and personal fees from Getinge. MS reports financial support from her tier 2 Canada Research Chair in Causal Inference and Machine Learning. KPS received grant funding from the NIH–NHLBI (grant number T32HL087738). FGZ received personal fees from Baxter Hospitalar. RZ received grant funding from the CIHR, Research Manitoba, and Octapharma. EF is supported by grants from the CIHR; and reports personal fees for speaking or consultancy from Aerogen, ALung Technologies, Baxter, Boehringer Ingelheim, Getinge, Inspira, Mallinckrodt, and Vasomune. MC received grant funding through his institution from the NIH–NHLBI (grant number R01HL157262-02), NIH–National Institute of Diabetes and Digestive Kidney Diseases (grant number R01DK126933A-01), NIH–NIGMS (grant numbers R35-13362546 and R01GM123193), and the DOD (grant number PRMRP W81XWH-21-1-0009); has a patent issued for a risk stratification algorithm (eCART) and receives royalties through his institution. ECG receives salary support and operating grant funds from the National Sanitarium Association; received grants from the CIHR; reports personal fees for speaking or consultancy from Getinge, Vyaire, Lungpacer, Stimit, Bioage, Heecap, Baxter, Zoll, and Drager; is on the advisory board of Getinge, Lungpacer, and Heecap; is on the DSMB of HiOX-SR; and received grant funding through his institution from the CIHR and National Sanitarium Association. All other authors declare no competing interests.

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Evidence-based personalised medicine in critical care: a framework for quantifying and applying individualised treatment effects in patients who are critically ill

Affiliations

Evidence-based personalised medicine in critical care: a framework for quantifying and applying individualised treatment effects in patients who are critically ill

Authors

Affiliations

Abstract

Conflict of interest statement

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical