Studies Using Core Outcome Measurement Set

Click to Enlarge

A NIH National Heart, Lung, and Blood Institute working group recommended this core outcome measurement set (COMS) for all studies evaluating post-hospital patient outcomes. PubMed

Below are example publications and study protocols that report all components of the Core Outcome Measurement Set (COMS) for post-hospital research of acute respiratory failure survivors.

To have publications and study protocols added to this list, please email us at improvelto@jhmi.edu or via our contact us page. 

Publications:

Minimum COMS

  • Cox CE, Hough CL,…,Porter LS. Effects of a telephone- and web-based coping skills training program compared to an education program for survivors of critical illness and their family members: a randomized clinical trial. American Journal of Respiratory and Critical Care Medicine. 2018; 197(1):66-78. PubMed
  • Derry HM, Lief L, Woubeshet N, Schenck EJ, Kakarala S, LaFond E, Berlin DA, Prigerson HG. Peritraumatic Stress Symptoms during Early Post-ICU Recovery. Ann Am Thorac Soc. Sep 1 2020. PubMed
  • Demoule A, Hajage D,…, Similowski T. Prevalence, intensity and clinical impact of dyspnea in critically ill patients receiving invasive ventilation. Am J Respir Crit Care Med. 2022 Jan 21. In Press PubMed (SF-36 instead of EQ-5D)
  • Geense WW, Zegers M, Peters MAA, Ewalds E, Simons KS, Vermeulen H, van der Hoeven JG, van den Boogaard M. New Physical, Mental, and Cognitive Problems 1-year Post-ICU: A Prospective Multicenter Study. Am J Respir Crit Care Med. 2021 Feb 1. PubMed (SF-36 instead of EQ-5D)
  • Geense WW, Zegers MAA, Vermeulen H, van den Boogaard M, van der Hoeven J. MONITOR-IC study, a mixed methods prospective multicenter controlled cohort study assessing 5-year outcomes of ICU survivors and related healthcare cost: a study protocol. BMJ Open. 2017 Nov 14;7(11):e018006. doi: 10.1136/bmjopen-2017-018006. PMID: 29138206; PMCID: PMC5695418. PubMed (SF-36 instead of EQ-5D)
  • Heesakkers H, Hoeven JG,…, Boogaard M. Mental health symptoms in family members of COVID-19 ICU survivors 3 and 12 months after ICU admission: a multicentre prospective cohort study. Intensive Care Medicine. 2022 Feb 1. Article PubMed (SF-12 instead of EQ-5D)
  • Hellemons ME, Huijts S,…,Aerts JGJV. Persistent health problems beyond pulmonary recovery up to 6 months after hospitalization for COVID-19: a longitudinal study of respiratory, physical, and psychological outcomes. Annals of the American Thoracic Society. 2022 Apr;19(4):551-561. ArticlePubMed (SF-36 instead of EQ-5D)
  • Hodgson CL, Udy AA,…, Cooper DJ. The impact of disability in survivors of critical illness. Intensive Care Med. 2017. PubMed
  • McGregor G, Sandhu H,…, Underwood M. Rehabilitation Exercise and psycholoGical support After COVID-19 InfectioN (REGAIN): a structured summary of a study protocol for a randomized controlled trail. Trials. 2021; 22:8. Article PubMed
  • Tripathy S, Acharya SP,…, Kar N. Post traumatic stress symptoms, anxiety, and depression in patients after intensive care unit discharge-a longitudinal cohort study from a LMIC tertiary care centre. BMC Psychiatry. 2020; 20(1):220. Article PubMed
  • Tripathy S, Kar N,…, Singh SK. ICU memories and patient outcomes in a low middle-income country: a longitudinal cohort study. Crit Care Med. 2021; 49(10):e978-e988. Article PubMed
  • Unoki T, Sakuramoto H, Uemura S,…, Masuda Y. Prevalence of and risk factors for post-intensive care syndrome: Multicenter study of patients living at home after treatment in 12 Japanese intensive care units, SMAP-HoPe study. 2021.16(5):e0252167. doi: 10.1371/journal.pone.0252167. Article; PubMed (in Japanese)
  • van Gelder TG, Lalmohamed A, …, Slooter AJC. Systemic glucocorticoid use during ICU admission and symptoms of posttraumatic stress disorder in intensive care unit survivors. Intensive Care Med. 2022 Jun;48(6):762-764. doi: 10.1007/s00134-022-06725-x. PubMed |
  • Wang S, Xin H, Chung C,…, Hu RF. Effect of an ICU diary on psychiatric disorders, quality of life, and sleep quality among adult cardiac surgical ICU survivors: a randomized controlled trial. Critical Care. 2020. 24(1). 81. PubMed (SF-36 instead of EQ-5D)
  • Watanabe S, Liu K,…, Kotani T. Association between early mobilization in the ICU and psychiatric symptoms after surviving a critical illness: a multi-center prospective cohort study. Journal of Clinical Medicine. 2022; 11(9):2587. doi: 10.3390/jcm11092587.  
  • Wong HZ, Brusseleers M,…, Gluck S. Mixed-mode versus paper surveys for patient-reported outcomes after critical illness: a randomised controlled trial. Australian Critical Care. 2022. 35(3):286-293. PubMed |

Minimum COMS + SF-36

  • Berney S, Hopkins RO, Rose JW, Koopman R, Puthucheary Z, Gordon I, Colantuoni E, Parry SM, Needham DM, Denehy L. Functional electrical stimulation in-bed cycle ergometry in mechanically ventilated patients: a multicenter randomized controlled trial. Thorax. 2020; Dec 15;
  • Dinglas VD, Hopkins RO,…, Needham DM. One-year outcomes of rosuvastatin vs. placebo in sepsis-associated acute respiratory distress syndrome:  prospective follow-up of SAILS randomized trial. Thorax. 2016; 71: 401-410. PubMed
  • Needham DM, Dinglas VD, Bienvenu OJ, Colantuoni E, Wozniak AW, Rice TW, Hopkins RO.  One year outcomes of initial trophic vs full enteral feeding in acute lung injury patients:  prospective follow-up of the EDEN randomized trial. British Medical Journal. 2013; Mar 19;346:f1532.  PMCID: PMC3601941
  • Ruhl AP, Huang M,…, Needham DM. Health care resource use and costs in long-term survivors of ARDS: a 5-year longitudinal cohort study. Critical Care Medicine. 2017;45:196-204. PubMed
  • Tramm R, Ilic D, Sheldrake J, Pellegrino V, Hodgson C. Recovery, risks, and adverse health outcomes in year 1 after extracorporeal membrane oxygenation. American Journal of Critical Care. 2017;26(4):311-319. PubMed
  • Vlake JH, Van Bommel J,…,Michel E. Psychologic distress and quality of life after ICU treatment for coronavirus disease 2019: a multicenter, observational cohort study. Critical Care Explorations. 2021; 3(8): e0497. PubMed

Minimum COMS + MoCA

  • Hodgson, C.L., Higgins, A.M…, The PREDICT Study Investigators. Comparison of 6-month outcomes of sepsis versus non-sepsis critically ill patients receiving mechanical ventilation. Critical Care. 2022 Jun 13;26(1):174. PubMed
  • Maley JH, Sandsmark DK,…,Lane-Fall MB. Six-month impairment in cognition, mental health, and physical function following COVID-19-associated respiratory failure. Critical Care Explorations. 2022 Mar 28;4(4):e0673. PubMed |
  • Rousseau AF, Minguet P,…,Misset B. Post-intensive care syndrome after a critical COVID-19: cohort study from a Belgian follow-up clinic.  Intensive Care. 2021. 11:118.  PubMed

Study Protocols:

  • A2B Trial – detailed information found at ClinicalTrials.gov (Minimum COMS + MoCA-Blind)
  • APICS – detailed information found at ClinicalTrials.gov (Minimum COMS + MoCA-Blind)
  • APICS-COVID – detailed information found at ClinicalTrials.gov (Minimum COMS + MoCA-Blind)
  • BEHAB – detailed information found at ClinicalTrials.gov (Minimum COMS + MoCA-Blind)
  • COVID-Recovery – detailed information found at ClinicalTrials.gov (Minimum COMS + MoCA-Blind)
  • GRAIL – detailed information found at ClinicalTrials.gov (Minimum COMS)
  • icuRESOLVE – detailed information found at ANZCTR.org.au (Minimum COMS)
  • IMPACCT COVID-19-detailed information found at ClinicalTrials.gov (Minumum COMS +MoCA-Blind)
  • NEXIS Study – detailed information found at ClinicalTrials.gov (Minimum COMS + MoCA-Blind)
  • PRECISe Trial – detailed information found at ClinicalTrials.gov (Minimum COMS + SF36)
  • PREDICT Study – detailed information found at ClinicalTrials.gov (Minimum COMS + MoCA-Blind)
  • PSBPS Study – detailed information found at ClinicalTrials.gov (Minimum COMS + MoCA-Blind)
  • TEAM III – detailed information found at ClinicalTrials.gov (Minimum COMS + MoCA-Blind)
  • Quality of Life and Patient-centered Outcomes After Hospitalization for COVID-19 – Detailed information found at ClinicalTrials.gov (Minimum COMS)