Institute of Social Medicine and Health Systems Research, Medical Faculty, Otto-von-Guericke University Magdeburg, Leipziger Str. 44, Magdeburg, 39120, Germany.
Health Qual Life Outcomes. 2024 Sep 12;22(1):79. doi: 10.1186/s12955-024-02289-0.
Acute rhinosinusitis (ARS) is a self-limiting inflammation of the nose and sinuses caused by viral or bacterial infections that requires primarily symptomatic treatment. Patient-reported outcome measures (PROMs) are suitable tools for the assessment of the effectiveness of remedies for ARS from the patient's perspective in clinical trials and real-world studies. Data regarding the quality of existing PROMs for ARS are limited.
To conduct a systematic review of the quality of existing disease-specific PROMs for use in adults and children with ARS according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology, and to derive recommendations for use of the identified instruments in future clinical studies.
We systematically searched PubMed, Web of Science and Embase for studies reporting on the development and/or validation of PROMs for ARS. We assessed the methodological quality of each included study, evaluated the quality of measurement properties per PROM and study, and graded the evidence. Based on the overall evidence, we derived recommendations for use of the instruments.
We identified four studies on three PROMs measuring symptoms of ARS and quality of life in adults (Sinonasal Outcome Test-16, SNOT-16; Measurement of Acute Rhinosinusitis, MARS; Rhinosinusitis Quality-of-Life Assessment, RhinoQoL). For ARS in children, we identified two studies on two PROMs measuring symptoms of ARS (Pediatric Rhinosinusitis Symptom Scale, PRSS; Sinus Symptom Questionnaire, S5). Our assessment of measurement properties indicates that all instruments require further validation before they can be unrestrictedly recommended for use in future research (COSMIN category B). In particular, there were no content validity studies for any of the identified instruments, but also data on other important measurement properties, e.g., structural validity, are lacking.
Currently, no PROM for ARS in adults and children can be unrestrictedly recommended based on the evaluation of their quality. Further validation is required for all identified PROMs. Content validation involving patients and experts should be given priority.
急性鼻-鼻窦炎（ARS）是一种由病毒或细菌感染引起的自限性鼻腔和鼻窦炎症，主要需要对症治疗。患者报告的结局测量（PROMs）是从患者角度评估 ARS 治疗效果的合适工具，可用于临床试验和真实世界研究。关于现有 ARS 特定 PROM 的质量数据有限。
根据共识基础的健康测量仪器选择标准（COSMIN）方法，对现有的用于成人和儿童 ARS 的特定疾病 PROM 的质量进行系统评价，并为未来临床研究中使用这些工具提供建议。
我们系统地检索了 PubMed、Web of Science 和 Embase 中关于 ARS 的 PROM 开发和/或验证的研究。我们评估了每个纳入研究的方法学质量，评估了每个 PROM 和研究的测量特性质量，并对证据进行了分级。根据总体证据，我们为仪器的使用提供了建议。
我们确定了四项关于成人 ARS 症状和生活质量的三种 PROM（鼻-鼻窦炎结局测试-16 项，SNOT-16；急性鼻-鼻窦炎测量，MARS；鼻-鼻窦炎生活质量评估，RhinoQoL）的研究。对于儿童 ARS，我们确定了两项关于 ARS 症状的两种 PROM（儿童鼻-鼻窦炎症状量表，PRSS；鼻窦症状问卷，S5）的研究。我们对测量特性的评估表明，所有仪器在广泛推荐用于未来研究之前都需要进一步验证（COSMIN 类别 B）。特别是，没有任何一种确定的仪器进行内容效度研究，但也缺乏其他重要测量特性的数据，例如，结构效度。
目前，基于对其质量的评估，没有一种用于成人和儿童 ARS 的 PROM 可以不受限制地推荐。所有确定的 PROM 都需要进一步验证。应优先考虑涉及患者和专家的内容验证。
