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

Abstract

ObjectivesThe 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.DesignA 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.ResultsThe 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.ConclusionImplementation 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.

Improvement of immune dysregulation in individuals with long COVID at 24-months following SARS-CoV-2 infection

“…The inclusion of three of the commonest symptoms of LC however ensures that these findings are broadly relevant, as is the inclusion of predominantly community managed patients with mild illness. The use of patient-reported symptoms (rather than clinical measures) is in line with the International Consortium for Health Outcomes Measurement COVID-19 standard set 33 , focusing primarily on outcomes that matter to patients. Our cohort mainly consists of patients who had acute infections of mild to moderate severity.…”

Content validity and psychometric properties of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus©) instrument in patients with COVID-19

“…Recently, FLU-PRO Plus was endorsed as an outcome measure by the International Consortium for Health Outcomes Measurement COVID-19 Working Group, further supporting its integration into research activities and in assessing COVID-19 symptoms [23]. Based on our findings and use of the FLU-PRO Plus in the COMET-ICE trial, the instrument is suitable for use in observational studies, clinical trials of COVID-19 treatments, and clinical practice with the purpose of evaluating COVID-19 symptoms and improvements, directly from the patient perspective.…”

Recommendations and effects of rehabilitation programs in older adults after hospitalization for COVID-19: A scoping review

“…Therefore, a multidisciplinary evaluation is important to identify and treat the different long-term symptoms in individuals who were infected with COVID-19 30 . For this reason, to monitor post-COVID-19 condition, the International Consortium for Health Outcomes Measurement COVID-19 Working Group has proposed to asses five domains: functional status and quality of life, mental functioning, social functioning, clinical outcomes, and symptoms 31 . On the other hand, the European Respiratory Society has developed a multidisciplinary statement to optimize clinical follow-up care in patients with post-COVID-19 condition that includes an intervention to improve quality of life and functional performance in daily life activities 30 .…”

“…30 For this reason, to monitor post-COVID-19 condition, the International Consortium for Health Outcomes Measurement COVID-19 Working Group has proposed to asses five domains: functional status and quality of life, mental functioning, social functioning, clinical outcomes, and symptoms. 31 On the other hand, the European Respiratory Society has developed a multidisciplinary statement to optimize clinical follow-up care in patients with post-COVID-19 condition that includes an intervention to improve quality of life and functional performance in daily life activities. 30 Likewise, the Stanford Hall consensus statement for post-COVID-19 rehabilitation has proposed a multidisciplinary intervention for the rehabilitation of these patients, including physical therapy, psychologic therapy, and nutritional advice.…”