TY - JOUR
T1 - Which outcomes are most important to measure in patients with COVID-19 and how and when should these be measured? Development of an international standard set of outcomes measures for clinical use in patients with COVID-19
T2 - A report of the International Consortium for Health Outcomes Measurement (ICHOM) COVID-19 Working Group
AU - Seligman, William H.
AU - Fialho, Luz
AU - Sillett, Nick
AU - Nielsen, Christina
AU - Baloch, Farhala M.
AU - Collis, Philip
AU - Demedts, Ingel K.M.
AU - Fleck, Marcelo P.
AU - Floriani, Maiara A.
AU - Gabriel, Lucinda E.K.
AU - Gagnier, Joel J.
AU - Keetharuth, Anju
AU - Londral, Ana
AU - Ludwig, Ingvar I.L.
AU - Lumbreras, Carlos
AU - Moscoso Daza, Alejandro
AU - Muhammad, Nasreen
AU - Nader Bastos, Gisele A.
AU - Owen, Christine W.
AU - Powers, John H.
AU - Russell, Anne Marie
AU - Smith, Michaela K.
AU - Wang, Tracy Y.P.
AU - Wong, Evan K.
AU - Woodhouse, Douglas C.
AU - Zimlichman, Eyal
AU - Brinkman, Kees
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2021/11/15
Y1 - 2021/11/15
N2 - Objectives: The COVID-19 pandemic has resulted in widespread morbidity and mortality with the consequences expected to be felt for many years. Significant variation exists in the care even of similar patients with COVID-19, including treatment practices within and between institutions. Outcome measures vary among clinical trials on the same therapies. Understanding which therapies are of most value is not possible unless consensus can be reached on which outcomes are most important to measure. Furthermore, consensus on the most important outcomes may enable patients to monitor and track their care, and may help providers to improve the care they offer through quality improvement. To develop a standardised minimum set of outcomes for clinical care, the International Consortium for Health Outcomes Measurement (ICHOM) assembled a working group (WG) of 28 volunteers, including health professionals, patients and patient representatives. Design: A list of outcomes important to patients and professionals was generated from a systematic review of the published literature using the MEDLINE database, from review of outcomes being measured in ongoing clinical trials, from a survey distributed to patients and patient networks, and from previously published ICHOM standard sets in other disease areas. Using an online-modified Delphi process, the WG selected outcomes of greatest importance. Results: The outcomes considered by the WG to be most important were selected and categorised into five domains: (1) functional status and quality of life, (2) mental functioning, (3) social functioning, (4) clinical outcomes and (5) symptoms. The WG identified demographic and clinical variables for use as case-mix risk adjusters. These included baseline demographics, clinical factors and treatment-related factors. Conclusion: Implementation of these consensus recommendations could help institutions to monitor, compare and improve the quality and delivery of care to patients with COVID-19. Their consistent definition and collection could also broaden the implementation of more patient-centric clinical outcomes research.
AB - Objectives: The COVID-19 pandemic has resulted in widespread morbidity and mortality with the consequences expected to be felt for many years. Significant variation exists in the care even of similar patients with COVID-19, including treatment practices within and between institutions. Outcome measures vary among clinical trials on the same therapies. Understanding which therapies are of most value is not possible unless consensus can be reached on which outcomes are most important to measure. Furthermore, consensus on the most important outcomes may enable patients to monitor and track their care, and may help providers to improve the care they offer through quality improvement. To develop a standardised minimum set of outcomes for clinical care, the International Consortium for Health Outcomes Measurement (ICHOM) assembled a working group (WG) of 28 volunteers, including health professionals, patients and patient representatives. Design: A list of outcomes important to patients and professionals was generated from a systematic review of the published literature using the MEDLINE database, from review of outcomes being measured in ongoing clinical trials, from a survey distributed to patients and patient networks, and from previously published ICHOM standard sets in other disease areas. Using an online-modified Delphi process, the WG selected outcomes of greatest importance. Results: The outcomes considered by the WG to be most important were selected and categorised into five domains: (1) functional status and quality of life, (2) mental functioning, (3) social functioning, (4) clinical outcomes and (5) symptoms. The WG identified demographic and clinical variables for use as case-mix risk adjusters. These included baseline demographics, clinical factors and treatment-related factors. Conclusion: Implementation of these consensus recommendations could help institutions to monitor, compare and improve the quality and delivery of care to patients with COVID-19. Their consistent definition and collection could also broaden the implementation of more patient-centric clinical outcomes research.
KW - COVID-19
KW - International health services
KW - Quality in healthcare
UR - http://www.scopus.com/inward/record.url?scp=85120162043&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-051065
DO - 10.1136/bmjopen-2021-051065
M3 - Article
C2 - 34782342
AN - SCOPUS:85120162043
SN - 2044-6055
VL - 11
JO - BMJ open
JF - BMJ open
IS - 11
M1 - e051065
ER -