Design, validation and implementation of the post-acute (long) COVID-19 quality of life (PAC-19QoL) instrument

BACKGROUND: The novel coronavirus (SARS-CoV-2) has led to a global pandemic, resulting in a disease termed COVID-19, which commonly presents in adults as a typical infection of the upper respiratory tract. Although the disease is often acute, one in ten patients can continue to be affected for weeks or months, resulting in a state called long COVID. Existing evidence suggests there are no patient-centred instruments for capturing the impact of long COVID on the quality of life of people affected. METHODS: The Jandhyala Method was used to identify indicators of long COVID quality of life. The resulting post-acute (long) COVID-19 Quality of Life (PAC-19QoL) instrument was validated with a control group of unaffected participants and finally implemented in the dedicated patient registry, PAC-19QoLReg. PARTICIPANTS: 15 participants suffering from long COVID, who have been positively diagnosed with COVID-19, either via diagnostic or antibody tests and a validation control group of 16 healthy participants who have not suffered from COVID-19. MAIN OUTCOME MEASURES: Indicators submitted by participants with long COVID that address the specific impact of the illness on their quality of life. RESULTS: Forty-four Quality of Life Indicators (QoLI) across four domains, namely, psychological, physical, social, and work, were agreed by the participants with long COVID to be relevant for the assessment of their quality of life (CI > 0.5). The validation stage identified 35/44 QoLIs that differentiated between the two groups, with a statistically significant difference between the mean QoLI Likert Scores (p < 0.05). CONCLUSIONS: The PAC-19QoL instrument and PAC-19QoLReg prospective observational cohort clinical study will enable an understanding of disease progression, on and off treatment, on the quality of life of patients with long COVID beyond simple symptomatology. Trial registration: ClinicalTrials.gov Identifier NCT04586413; 14th October 2020.