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. 2021 Nov 15;11(11):e051065.
doi: 10.1136/bmjopen-2021-051065.

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: a report of the International Consortium for Health Outcomes Measurement (ICHOM) COVID-19 Working Group

William H Seligman  1 , Luz Fialho  2 , Nick Sillett  2 , Christina Nielsen  2 , Farhala M Baloch  3 , Philip Collis  4 , Ingel K M Demedts  5 , Marcelo P Fleck  6 , Maiara A Floriani  7 , Lucinda E K Gabriel  8 , Joel J Gagnier  9 , Anju Keetharuth  10 , Ana Londral  11 , Ingvar I L Ludwig  12 , Carlos Lumbreras  13 , Alejandro Moscoso Daza  14 , Nasreen Muhammad  3 , Gisele A Nader Bastos  7 , Christine W Owen  15 , John H Powers  16 , Anne-Marie Russell  17 , Michaela K Smith  18 , Tracy Y-P Wang  19 , Evan K Wong  20 , Douglas C Woodhouse  21 , Eyal Zimlichman  22 , Kees Brinkman  23
Affiliations

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: a report of the International Consortium for Health Outcomes Measurement (ICHOM) COVID-19 Working Group

William H Seligman et al. BMJ Open. .

Abstract

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.

Keywords: COVID-19; international health services; quality in healthcare.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Timeline and data collection process.
Figure 2
Figure 2
Follow-up timeline and data collection guidance. PROM, patient-reported outcome measure.
See this image and copyright information in PMC

References

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