Assessing the patient experience of respiratory syncytial virus infection: development of a patient-reported outcome measure
Abstract Background Respiratory syncytial virus (RSV) causes significant morbidity and mortality in older adults. Despite a number of RSV vaccine candidates in clinical trials, there are no existing disease-specific, self-reported measures that assess the symptoms and severity of RSV infection from...
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| Format: | Article |
| Language: | English |
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BMC
2023-02-01
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| Series: | Health and Quality of Life Outcomes |
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| Online Access: | https://doi.org/10.1186/s12955-022-02066-x |
| _version_ | 1797863493158830080 |
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| author | Carla (DeMuro) Romano Lyn Finelli Sandy Lewis Valerie Williams Emily Martin Matthew Phillips Todd L. Saretsky Josephine Norquist |
| author_facet | Carla (DeMuro) Romano Lyn Finelli Sandy Lewis Valerie Williams Emily Martin Matthew Phillips Todd L. Saretsky Josephine Norquist |
| author_sort | Carla (DeMuro) Romano |
| collection | DOAJ |
| description | Abstract Background Respiratory syncytial virus (RSV) causes significant morbidity and mortality in older adults. Despite a number of RSV vaccine candidates in clinical trials, there are no existing disease-specific, self-reported measures that assess the symptoms and severity of RSV infection from the perspective of adult patients with acute RSV. The objective of this study was to describe the initial conceptualization and development of the RSV Infection, Intensity and Impact Questionnaire (RSV-iiiQ), a new patient-reported outcome measure. Methods A targeted review of the literature identified relevant existing measures, symptoms, and impacts of RSV. A draft version of the RSV-iiiQ was developed based on the Influenza Intensity and Impact Questionnaire (Flu-iiQ) with expert input. Qualitative interviews (N = 20) were conducted with participants to optimize the RSV-iiiQ conceptual model and confirm the content validity of the RSV-iiiQ. Interviews included concept elicitation and a cognitive debriefing assessment. A draft conceptual framework was developed, and the electronic clinical outcome assessment was piloted. All steps of instrument development followed Food and Drug Administration guidance for patient-reported outcomes. Results In-depth concept elicitation interviews followed by cognitive debriefings demonstrated that the content of the items was comprehensive, covered the breadth of RSV symptoms and impacts, and was relevant to the experiences of individuals with RSV. Both the paper and electronic versions of the RSV-iiiQ were easily completed. Minor refinements were made to some items based on participant feedback, and the draft conceptual framework was refined. Conclusions The RSV-iiiQ was developed for use in clinical trials to measure the symptom intensity and impact of acute RSV infection from the perspective of adult patients. The tool was developed in accordance with current regulatory guidance and is useful to support patient-focused drug development. |
| first_indexed | 2024-04-09T22:36:21Z |
| format | Article |
| id | doaj.art-afe382a223984a7f92f004327720f42c |
| institution | Directory Open Access Journal |
| issn | 1477-7525 |
| language | English |
| last_indexed | 2024-04-09T22:36:21Z |
| publishDate | 2023-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Health and Quality of Life Outcomes |
| spelling | doaj.art-afe382a223984a7f92f004327720f42c2023-03-22T12:27:00ZengBMCHealth and Quality of Life Outcomes1477-75252023-02-0121111210.1186/s12955-022-02066-xAssessing the patient experience of respiratory syncytial virus infection: development of a patient-reported outcome measureCarla (DeMuro) Romano0Lyn Finelli1Sandy Lewis2Valerie Williams3Emily Martin4Matthew Phillips5Todd L. Saretsky6Josephine Norquist7RTI Health SolutionsCenter for Observational and Real-World Evidence, Merck and Co., IncRTI Health SolutionsRTI Health SolutionsSchool of Public Health, University of MichiganCenter for Observational and Real-World Evidence, Merck and Co., IncBiostatistics and Research Data Sciences, Patient-Centered Endpoints and Strategy Group, Merck and Co., IncBiostatistics and Research Data Sciences, Patient-Centered Endpoints and Strategy Group, Merck and Co., IncAbstract Background Respiratory syncytial virus (RSV) causes significant morbidity and mortality in older adults. Despite a number of RSV vaccine candidates in clinical trials, there are no existing disease-specific, self-reported measures that assess the symptoms and severity of RSV infection from the perspective of adult patients with acute RSV. The objective of this study was to describe the initial conceptualization and development of the RSV Infection, Intensity and Impact Questionnaire (RSV-iiiQ), a new patient-reported outcome measure. Methods A targeted review of the literature identified relevant existing measures, symptoms, and impacts of RSV. A draft version of the RSV-iiiQ was developed based on the Influenza Intensity and Impact Questionnaire (Flu-iiQ) with expert input. Qualitative interviews (N = 20) were conducted with participants to optimize the RSV-iiiQ conceptual model and confirm the content validity of the RSV-iiiQ. Interviews included concept elicitation and a cognitive debriefing assessment. A draft conceptual framework was developed, and the electronic clinical outcome assessment was piloted. All steps of instrument development followed Food and Drug Administration guidance for patient-reported outcomes. Results In-depth concept elicitation interviews followed by cognitive debriefings demonstrated that the content of the items was comprehensive, covered the breadth of RSV symptoms and impacts, and was relevant to the experiences of individuals with RSV. Both the paper and electronic versions of the RSV-iiiQ were easily completed. Minor refinements were made to some items based on participant feedback, and the draft conceptual framework was refined. Conclusions The RSV-iiiQ was developed for use in clinical trials to measure the symptom intensity and impact of acute RSV infection from the perspective of adult patients. The tool was developed in accordance with current regulatory guidance and is useful to support patient-focused drug development.https://doi.org/10.1186/s12955-022-02066-xRespiratory syncytial virus (RSV)RSV Infection, Intensity and Impact Questionnaire (RSV-iiiQ)SymptomsImpactDisease burden |
| spellingShingle | Carla (DeMuro) Romano Lyn Finelli Sandy Lewis Valerie Williams Emily Martin Matthew Phillips Todd L. Saretsky Josephine Norquist Assessing the patient experience of respiratory syncytial virus infection: development of a patient-reported outcome measure Health and Quality of Life Outcomes Respiratory syncytial virus (RSV) RSV Infection, Intensity and Impact Questionnaire (RSV-iiiQ) Symptoms Impact Disease burden |
| title | Assessing the patient experience of respiratory syncytial virus infection: development of a patient-reported outcome measure |
| title_full | Assessing the patient experience of respiratory syncytial virus infection: development of a patient-reported outcome measure |
| title_fullStr | Assessing the patient experience of respiratory syncytial virus infection: development of a patient-reported outcome measure |
| title_full_unstemmed | Assessing the patient experience of respiratory syncytial virus infection: development of a patient-reported outcome measure |
| title_short | Assessing the patient experience of respiratory syncytial virus infection: development of a patient-reported outcome measure |
| title_sort | assessing the patient experience of respiratory syncytial virus infection development of a patient reported outcome measure |
| topic | Respiratory syncytial virus (RSV) RSV Infection, Intensity and Impact Questionnaire (RSV-iiiQ) Symptoms Impact Disease burden |
| url | https://doi.org/10.1186/s12955-022-02066-x |
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