Institute of Social Medicine and Health Systems Research, Medical Faculty, Otto-von-Guericke University Magdeburg, Leipziger Str. 44, 39120, Magdeburg, Germany.
Qual Life Res. 2023 Aug;32(8):2137-2153. doi: 10.1007/s11136-023-03358-5. Epub 2023 Feb 16.
To conduct a systematic review of the quality of existing patient-reported outcome measures (PROMs) for use in women with uncomplicated urinary tract infections (UTIs) applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology, and to derive recommendations for their use in future research.
A systematic literature search was performed in PubMed and Web of Science. Studies reporting on the development and/or validation of any PROMs for uncomplicated UTIs in women were considered eligible. We evaluated the methodological quality of each included study using the COSMIN Risk of Bias Checklist, and further applied predefined criteria for good measurement properties. Finally, we graded the evidence and derived recommendations for the use of the included PROMs.
Data from 23 studies reporting on six PROMs were included. From those, the Acute Cystitis Symptom Score (ACSS) and the Urinary Tract Infection-Symptom and Impairment Questionnaire (UTI-SIQ-8) can be recommended for further use. Both instruments showed sufficient content validity. We further found high-quality evidence for sufficient internal consistency of the UTI-SIQ-8, while this criterion was not assessed for the ACSS due to a formative measurement model. All other PROMs have the potential to be recommended for use, but require further validation.
The ACSS and the UTI-SIQ-8 have the potential to be recommended for use in women with uncomplicated UTIs in future clinical trials. For all included PROMs, further validation studies are indicated.
PROSPERO.
应用共识基础的健康测量仪器选择标准（COSMIN）方法，对用于治疗单纯性尿路感染（UTI）女性的现有患者报告结局测量（PROM）工具的质量进行系统评价，并为未来的研究提供使用这些工具的建议。
在 PubMed 和 Web of Science 中进行了系统的文献检索。报告任何用于女性单纯性 UTI 的 PROM 开发和/或验证的研究都被认为符合入选标准。我们使用 COSMIN 偏倚风险清单评估了每个纳入研究的方法学质量，并进一步应用了良好测量特性的预定义标准。最后，我们对纳入的 PROM 的证据进行了分级，并提出了使用建议。
纳入了 23 项研究的数据，这些研究报告了 6 种 PROM。其中，急性膀胱炎症状评分（ACSS）和尿路感染症状和障碍问卷（UTI-SIQ-8）可推荐进一步使用。这两种工具均具有充分的内容有效性。我们还发现 UTI-SIQ-8 的内部一致性具有高质量的证据，而由于形成性测量模型，ACSS 未评估这一标准。所有其他 PROM 都有可能被推荐使用，但需要进一步验证。
ACSS 和 UTI-SIQ-8 有可能被推荐用于未来的临床试验中治疗单纯性 UTI 的女性。所有纳入的 PROM 都需要进一步的验证研究。
PROSPERO。
