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10.1007/s40271-022-00591-x

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suck abstract from ncbi


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pmid35857266      Patient 2022 ; 15 (6): 703-713
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  • Development of an Item Bank to Assess Patient-Reported Outcomes: Signs, Symptoms, and Impacts of COVID-19 #MMPMID35857266
  • Reaney M; Turnbull J; Paty J; Heuer K; Gwaltney C
  • Patient 2022[Nov]; 15 (6): 703-713 PMID35857266show ga
  • BACKGROUND AND OBJECTIVE: Patients experience a wide range of signs, symptoms, and impacts related to coronavirus disease 2019 (COVID-19). A patient-reported outcome (PRO) item bank that measures the most relevant patient experiences is needed to fully evaluate treatment benefit in COVID-19 clinical trials. METHODS: A review of the literature and social media informed a novel PRO item bank of COVID-19 signs, symptoms, and impacts and general pandemic impacts. Twenty 1:1 concept elicitation and cognitive debriefing interviews were conducted with adults in the US who had symptomatic COVID-19. A conceptual model was developed and the PRO item bank refined following interviews. RESULTS: A heterogenous set of signs, symptoms, and impacts of COVID-19, as well as impacts associated with the pandemic overall, was identified. Fifty-five short-term and long-term signs and symptom items, 26 items assessing disease-related impacts, and seven items evaluating pandemic-related impacts are included in the item bank. CONCLUSIONS: The novel and preliminarily content-valid IQVIA COVID-19 Daily Diary Item Bank((c)) and the IQVIA COVID-19 Weekly Diary Item Bank((c)) were developed to measure signs and symptoms, their associated severity, and disease-related and pandemic-related impacts. The items are arranged in seven groups and can be individually selected based on research needs.
  • |*COVID-19[MESH]
  • |*Patient Reported Outcome Measures[MESH]
  • |Adult[MESH]
  • |Humans[MESH]
  • |Quality of Life/psychology[MESH]


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