Design, validation and implementation of the Post-Acute (long) COVID-19 Quality of Life (PAC-19QoL) instrument in the PAC-19QoLReg patient registry
Abstract Background To design, validate and implement a Post-Acute (long) COVID-19 disease-specific quality of life instrument, (the PAC-19QoL), in a dedicated patient registry, PAC-19QoLReg, to observe changes in quaQoL over a 12-month period. Methods The Jandhyala Method was used to identify indicators of long COVID quality of life. The resulting PAC-19QoL was validated with a control group of unaffected participants and finally implemented in the dedicated 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 in their quality of life. Results Forty-four Quality of Life Indicators (QoLI) across four domains – psychological, physical, emotional and work-related – 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