Development and content validation of the Long COVID/ post-acute sequelae of COVID-19 (PASC) patient-reported outcome (PRO) instrument
Abstract Background Post-acute sequelae of COVID-19 (PASC) or Long COVID is a post-viral complication of SARS-CoV-2 infection, causing ongoing symptoms and impaired function over a prolonged period of time. There is limited understanding of how the signs and symptoms of Long COVID/PASC affect patien...
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SpringerOpen
2025-08-01
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| Series: | Journal of Patient-Reported Outcomes |
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| Online Access: | https://doi.org/10.1186/s41687-025-00942-w |
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| author | Dale Chandler Benjamin Abramoff Candace Bramson Joseph. C. Cappelleri Aishwarya Chohan Magdalena Harrington Hiba Jamal Jillian Lusk Iyar Mazar Roger Paredes Sophi Tatlock Andrew Ustianowski Edward Weinstein Ruth Mokgokong |
| author_facet | Dale Chandler Benjamin Abramoff Candace Bramson Joseph. C. Cappelleri Aishwarya Chohan Magdalena Harrington Hiba Jamal Jillian Lusk Iyar Mazar Roger Paredes Sophi Tatlock Andrew Ustianowski Edward Weinstein Ruth Mokgokong |
| author_sort | Dale Chandler |
| collection | DOAJ |
| description | Abstract Background Post-acute sequelae of COVID-19 (PASC) or Long COVID is a post-viral complication of SARS-CoV-2 infection, causing ongoing symptoms and impaired function over a prolonged period of time. There is limited understanding of how the signs and symptoms of Long COVID/PASC affect patients’ lives and how to measure them, which is essential when developing care strategies. This study aimed to develop and evaluate the content validity for a novel patient-reported outcome (PRO) instrument in Long COVID/PASC through qualitative research, which was informed by the patient experience of Long COVID/PASC and both patient and clinician input. Methods A review of literature and PRO instruments developed for Long COVID/PASC identified measurement gaps for the context of use (i.e., weekly assessment of signs/symptoms in clinical trial research). This informed the development of the preliminary Long COVID/PASC PRO instrument, which was tested via patient interviews (combined concept elicitation and cognitive debriefing) to align with regulatory standards, and discussions with clinical experts were conducted to provide clinical insights. The final instrument was modified based on this input to further promote its content validity. Results Thirty participants were interviewed about their Long COVID/PASC experiences. Participants most frequently reported experiencing tiredness after physical activity (n = 29/30; 97%), general tiredness (n = 28/30; 93%), shortness of breath (n = 25/30; 83%), cough (n = 23/30; 77%) and muscle/body aches (n = 23/30; 77%). All participants reported that Long COVID/PASC had an impact on their health-related quality of life. Almost all (n = 27/28; 96%) sign/symptom concepts were reported in the first three sets of interviews suggesting conceptual saturation was achieved. Items, response options and the recall period of the preliminary Long COVID/PASC PRO instrument were understood as intended (≥ 90%) and relevant to most participants across both rounds (≥ 47%). Modifications were made to the instrument following patient input, resulting in the 18-item Long COVID/PASC instrument. Clinician input (n = 3) corroborated participant interview results, supporting the content validity of the Long COVID/PASC PRO instrument. Conclusion The Long COVID/PASC PRO instrument has been developed in line with regulatory standards and the qualitative evidence demonstrated strong content validity in a Long COVID/PASC population. Research to evaluate psychometric properties will provide further evidence of the instrument’s measurement properties. |
| format | Article |
| id | doaj-art-bb32dbf0f72f4567be7f74fd2d13c592 |
| institution | Kabale University |
| issn | 2509-8020 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | Journal of Patient-Reported Outcomes |
| spelling | doaj-art-bb32dbf0f72f4567be7f74fd2d13c5922025-08-24T11:32:37ZengSpringerOpenJournal of Patient-Reported Outcomes2509-80202025-08-019111210.1186/s41687-025-00942-wDevelopment and content validation of the Long COVID/ post-acute sequelae of COVID-19 (PASC) patient-reported outcome (PRO) instrumentDale Chandler0Benjamin Abramoff1Candace Bramson2Joseph. C. Cappelleri3Aishwarya Chohan4Magdalena Harrington5Hiba Jamal6Jillian Lusk7Iyar Mazar8Roger Paredes9Sophi Tatlock10Andrew Ustianowski11Edward Weinstein12Ruth Mokgokong13Patient-Centered Outcomes, Adelphi Values LtdUniversity of PennsylvaniaPfizer IncPfizer IncPatient-Centered Outcomes, Adelphi Values LtdPfizer IncPatient-Centered Outcomes, Adelphi Values LtdPfizer IncPfizer IncDepartment of Infectious Diseases, Hospital Germans Trias i Pujol and irsiCaixaPatient-Centered Outcomes, Adelphi Values LtdRegional Infectious Diseases Unit, North Manchester General HospitalPfizer IncPfizer LtdAbstract Background Post-acute sequelae of COVID-19 (PASC) or Long COVID is a post-viral complication of SARS-CoV-2 infection, causing ongoing symptoms and impaired function over a prolonged period of time. There is limited understanding of how the signs and symptoms of Long COVID/PASC affect patients’ lives and how to measure them, which is essential when developing care strategies. This study aimed to develop and evaluate the content validity for a novel patient-reported outcome (PRO) instrument in Long COVID/PASC through qualitative research, which was informed by the patient experience of Long COVID/PASC and both patient and clinician input. Methods A review of literature and PRO instruments developed for Long COVID/PASC identified measurement gaps for the context of use (i.e., weekly assessment of signs/symptoms in clinical trial research). This informed the development of the preliminary Long COVID/PASC PRO instrument, which was tested via patient interviews (combined concept elicitation and cognitive debriefing) to align with regulatory standards, and discussions with clinical experts were conducted to provide clinical insights. The final instrument was modified based on this input to further promote its content validity. Results Thirty participants were interviewed about their Long COVID/PASC experiences. Participants most frequently reported experiencing tiredness after physical activity (n = 29/30; 97%), general tiredness (n = 28/30; 93%), shortness of breath (n = 25/30; 83%), cough (n = 23/30; 77%) and muscle/body aches (n = 23/30; 77%). All participants reported that Long COVID/PASC had an impact on their health-related quality of life. Almost all (n = 27/28; 96%) sign/symptom concepts were reported in the first three sets of interviews suggesting conceptual saturation was achieved. Items, response options and the recall period of the preliminary Long COVID/PASC PRO instrument were understood as intended (≥ 90%) and relevant to most participants across both rounds (≥ 47%). Modifications were made to the instrument following patient input, resulting in the 18-item Long COVID/PASC instrument. Clinician input (n = 3) corroborated participant interview results, supporting the content validity of the Long COVID/PASC PRO instrument. Conclusion The Long COVID/PASC PRO instrument has been developed in line with regulatory standards and the qualitative evidence demonstrated strong content validity in a Long COVID/PASC population. Research to evaluate psychometric properties will provide further evidence of the instrument’s measurement properties.https://doi.org/10.1186/s41687-025-00942-wCognitive debriefing (CD)Concept elicitation (CE)Content validityPatient-reported outcome (PRO)Qualitative interviewsLong COVID |
| spellingShingle | Dale Chandler Benjamin Abramoff Candace Bramson Joseph. C. Cappelleri Aishwarya Chohan Magdalena Harrington Hiba Jamal Jillian Lusk Iyar Mazar Roger Paredes Sophi Tatlock Andrew Ustianowski Edward Weinstein Ruth Mokgokong Development and content validation of the Long COVID/ post-acute sequelae of COVID-19 (PASC) patient-reported outcome (PRO) instrument Journal of Patient-Reported Outcomes Cognitive debriefing (CD) Concept elicitation (CE) Content validity Patient-reported outcome (PRO) Qualitative interviews Long COVID |
| title | Development and content validation of the Long COVID/ post-acute sequelae of COVID-19 (PASC) patient-reported outcome (PRO) instrument |
| title_full | Development and content validation of the Long COVID/ post-acute sequelae of COVID-19 (PASC) patient-reported outcome (PRO) instrument |
| title_fullStr | Development and content validation of the Long COVID/ post-acute sequelae of COVID-19 (PASC) patient-reported outcome (PRO) instrument |
| title_full_unstemmed | Development and content validation of the Long COVID/ post-acute sequelae of COVID-19 (PASC) patient-reported outcome (PRO) instrument |
| title_short | Development and content validation of the Long COVID/ post-acute sequelae of COVID-19 (PASC) patient-reported outcome (PRO) instrument |
| title_sort | development and content validation of the long covid post acute sequelae of covid 19 pasc patient reported outcome pro instrument |
| topic | Cognitive debriefing (CD) Concept elicitation (CE) Content validity Patient-reported outcome (PRO) Qualitative interviews Long COVID |
| url | https://doi.org/10.1186/s41687-025-00942-w |
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