Postgraduate medicine · 2025
Feasibility of a virtual, prospective real-world data study in acute rhinosinusitis.
СтатьяНазвание и аннотация: Перевод в очереди
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Bittner Claudia B, Plach Michael, Hoch Stefan, Steindl Hubert, Klein Lisa, Kruse Tobias, Abels Christoph, Bachert Claus
Аннотация
OBJECTIVES: This exploratory study evaluated the feasibility of solely virtually recruiting patients with symptoms suggestive of acute rhinosinusitis (ARS) and whether a questionnaire-based study on disease history, use of over-the-counter (OTC) medications and symptom burden in ARS can provide plausible and meaningful results.
METHODS: The study was advertised via Google Ads and on social media (Facebook, Instagram, and TikTok). Its questionnaire contained 20 questions regarding disease history and use of OTC medicinal products such as BNO 1016 (Sinupret® extract). Symptomatic burden and disease impact were evaluated by patient-reported outcome measures (PROMs), i.e. the major symptom score in a patient-assessed form (MSSPAT) and bothersomeness of symptoms on a numerical rating scale (NRS). A subgroup of participants also completed the Sino-Nasal Outcome Test-20 German Adapted Version (SNOT-20 GAV). Analyses on correlation of PROMs and parameters that influence outcomes of PROMs were performed after the study.
RESULTS: During 8 weeks in winter/spring 2024, 2889 people wanted to participate in the study, 2032 (70.3%) participants over the age of 16 and with a history of ARS were finally included. There was a great willingness to participate and complete the study, as 93.7% of eligible starters also completed the study. The majority of included participants were female (83.7%) and between 25 and 54 years old (52.6%). PROMs were well accepted by participants and provided plausible results (mean MSSPAT: 8.3 score points; NRS in 86.6% rated with at least 5; mean SNOT-20 GAV: 45.5 score points). Moreover, PROM scores correlated with each other, indicating their validity for assessing ARS disease burden and impact also in a real-world setting.
CONCLUSION: This feasibility study showed that it appears indeed possible to generate real-world data (RWD) in ARS in a solely virtual setting. We are planning a larger prospective virtual RWD study as the next step to gain deeper insights into the treatment course of ARS.
METHODS: The study was advertised via Google Ads and on social media (Facebook, Instagram, and TikTok). Its questionnaire contained 20 questions regarding disease history and use of OTC medicinal products such as BNO 1016 (Sinupret® extract). Symptomatic burden and disease impact were evaluated by patient-reported outcome measures (PROMs), i.e. the major symptom score in a patient-assessed form (MSSPAT) and bothersomeness of symptoms on a numerical rating scale (NRS). A subgroup of participants also completed the Sino-Nasal Outcome Test-20 German Adapted Version (SNOT-20 GAV). Analyses on correlation of PROMs and parameters that influence outcomes of PROMs were performed after the study.
RESULTS: During 8 weeks in winter/spring 2024, 2889 people wanted to participate in the study, 2032 (70.3%) participants over the age of 16 and with a history of ARS were finally included. There was a great willingness to participate and complete the study, as 93.7% of eligible starters also completed the study. The majority of included participants were female (83.7%) and between 25 and 54 years old (52.6%). PROMs were well accepted by participants and provided plausible results (mean MSSPAT: 8.3 score points; NRS in 86.6% rated with at least 5; mean SNOT-20 GAV: 45.5 score points). Moreover, PROM scores correlated with each other, indicating their validity for assessing ARS disease burden and impact also in a real-world setting.
CONCLUSION: This feasibility study showed that it appears indeed possible to generate real-world data (RWD) in ARS in a solely virtual setting. We are planning a larger prospective virtual RWD study as the next step to gain deeper insights into the treatment course of ARS.