CoV-Sym: The development of a psychometrically validated patient reported outcome measure for COVID-19

Abstract

<b>Background:</b> Patient reported outcome measures (PROMs) provide a standardised method to capture patient perspectives which can be used in comparative effectiveness research to inform the evaluation of treatment. Thus far, PROMs have focussed on the long-term sequelae of COVID-19 rather than the acute illness and initial recovery period. <b>Aim:</b> To design a psychometrically validated COVID-19 specific PROM to be used in the acute and recovery phase of illness. <b>Methods:</b> A review of existing literature, evaluation of existing PROMs, input from local experts (<i>n</i>=15) and in-depth qualitative concept elicitation interviews with patients (<i>n</i>=8) were used to create a conceptual framework which informed the generation of items included in the PROM. Cognitive interviews with patients (<i>n</i>=8) were then used to develop and refine the items for inclusion in the PROM and confirm the content and face validity of the draft tool. A nominal group meeting of the expert panel (<i>n</i>=6) was held to confirm the final items for inclusion. <b>Results:</b> The CoV-Sym PROM consists of 19 domains and 44 items which are scored using a five-point Likert scale to enable objective measurement of patients’ symptomatic recovery from acute COVID-19 illness. Questions address physical, psychological and social domains. Cognitive interviews revealed acceptable content and face validity. <b>Conclusion:</b> With the involvement of both patients and experts in the development and validation process, we have created the first COVID-19 specific PROM to measure patient’s symptomatic recovery from acute COVID-19 infection. It is ready for further psychometric testing to confirm reliability and responsiveness, the results of which will be presented.