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.
This asset is part of our #corporatesocialresponsibility program and highlights our commitment to improving #construct measurement in #clinicaltrials, #clinicalstudies and #realworldevidence in those living with disease.
This has been the driving force behind the generation of this new scale for assessing #qualityoflife life in patients with post-acute #longcovid-19, the first disease-specific measure for this outcome in this population. Additionally, we have demonstrated how applying #Neutraltheory via the #jandhyalamethod can develop a disease-specific quality of life instrument.
We are pleased to announce that it is now implemented in the dedicated #patientregistry, the PAC-19QoLReg (ClinicalTrials.gov Identifier: NCT04586413).
Through the creation of this measure and #registry, we hope to improve the monitoring of quality-of-life #outcomes resulting from various treatments in this population and contribute towards a better understanding of disease progression and #diseasemanagement. Contact us at Medialis Ltd to find out how our approach can be used to improve construct measurement in your area of interest and join us in #ImprovingPatientOutcomes. #covid #health #medicalaffairs #clinicalresearch #pharmaceuticals
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