Mishra Eleanor K, Stanton Andrew
Respiratory Medicine, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, GBR.
Faculty of Medicine and Health Science, University of East Anglia, Norwich, GBR.
Cureus. 2024 Jan 17;16(1):e52430. doi: 10.7759/cureus.52430. eCollection 2024 Jan.
Pleural effusions cause breathlessness, decreased activity levels, and impaired quality of life. Clinical trials of drainage of pleural effusion use patient-reported outcome measures (PROMs) to assess these variables. This systematic review aimed to identify which PROMs have been used in clinical trials in pleural effusions, what variables were assessed, whether they were responsive to pleural interventions, and whether they have been validated in patients with pleural effusions, including a defined minimal clinically important difference (MCID). A systematic review was performed to identify relevant clinical trials from Medline, EMBASE, Emcare, and CINAHL and data were extracted. From 329 abstracts, 29 clinical trials of pleural effusion drainage that used PROMs as an outcome measure were identified. A total of 16 different PROMs were used. The most used PROMs were unidimensional measurements of breathlessness, particularly the visual analogue scale for dyspnoea (VASD), all of which nearly showed improvements in breathlessness following pleural fluid drainage. Other variables commonly assessed included activity levels and health-related quality of life. Multidimensional PROMs showed inconsistent responsiveness to pleural fluid drainage. Only the VASD was validated in this patient group with a defined MCID. A range of PROMs are used in clinical trials of pleural fluid drainage. No single PROM measures all the outcomes of interest. Unidimensional measurements of breathlessness are responsive to pleural fluid drainage. Only the VASD is validated with an MCID. There is a need for properly validated, response PROMs which measure the key outcomes of interest in this patient group.
胸腔积液会导致呼吸急促、活动水平下降及生活质量受损。胸腔积液引流的临床试验采用患者报告结局指标（PROMs）来评估这些变量。本系统评价旨在确定哪些PROMs已用于胸腔积液的临床试验、评估了哪些变量、它们对胸腔干预措施是否有反应，以及它们是否在胸腔积液患者中得到验证，包括确定的最小临床重要差异（MCID）。进行了一项系统评价，以从Medline、EMBASE、Emcare和CINAHL中识别相关临床试验并提取数据。从329篇摘要中，识别出29项以PROMs作为结局指标的胸腔积液引流临床试验。总共使用了16种不同的PROMs。使用最多的PROMs是对呼吸急促的单维测量，尤其是呼吸困难视觉模拟量表（VASD），所有这些量表几乎都显示胸腔积液引流后呼吸急促有所改善。其他常见评估变量包括活动水平和健康相关生活质量。多维PROMs对胸腔积液引流的反应不一致。只有VASD在该患者组中得到验证且有确定的MCID。一系列PROMs用于胸腔积液引流的临床试验。没有单一的PROM能测量所有感兴趣的结局。对呼吸急促的单维测量对胸腔积液引流有反应。只有VASD通过MCID得到验证。需要有经过适当验证的、能反映该患者组关键感兴趣结局的反应性PROMs。
