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.

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.

Psychometric Evaluation of the Chinese Recovering Quality of Life (ReQoL) Outcome Measure and Assessment of Health-Related Quality of Life During the COVID-19 Pandemic.

OBJECTIVE: The primary objective was to translate the Recovering Quality of Life (ReQoL) measures from English to traditional Chinese and assess their psychometric properties in Hong Kong (HK) Chinese population. The secondary objective was to investigate the mental health-related quality of life (HRQoL) of this sample during the coronavirus disease 2019 (COVID-19) pandemic. METHOD: Recovering Quality of Life was translated to Traditional Chinese adhering to standard guideline recommended by the official distributors. Five hundred members of the general population were successfully recruited to participate in a telephone-based survey. The following psychometric properties of the ReQoL were evaluated: construct, convergent, and known-group validity and internal consistency and test-retest reliability. The item measurement invariance was assessed on the basis of differential item functioning (DIF). Multiple regression analysis was used to assess the relationship between respondents' characteristics and mental HRQoL. RESULTS: Results of confirmatory factor analysis (CFA) supported a two-factor structure of the ReQoL. The ReQoL showed significant correlations with the other mental health, quality of life, and well-being measures, which indicated a satisfactory convergent validity. Known-group validity confirmed that ReQoL is able to differentiate between people with different mental health status. The (Cronbach's alpha = 0.91 and 0.76 for positive [PF] and negative [NF] factor), and McDonald's omega of 0.89 (PF = 0.94, NF = 0.82) indicated the ReQoL has good reliability as well as test-retest reliability with an intraclass correlation coefficient of 0.75. Four items showed negligible DIF with respect to age. Respondents who were highly educated and without psychological problems reported a high ReQoL score. CONCLUSION: Traditional Chinese ReQoL was shown to be a valid and reliable instrument to assess the recovery-focused quality of life in HK general population. Future studies are needed to appraise its psychometric properties in local people experiencing mental disorders.