Studies Using Core Outcome Measurement Set

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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. 2017. In Press. 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
  • 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. MONITER-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)
  • 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
  • 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)
  • 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)

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

  • 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)