Shah Hiral Anil, Dritsaki Melina, Pink Joshua, Petrou Stavros
Public Health Foundation of India, Delhi NCR, India.
Oxford Clinical Trials Research Unit, Nuffield Department of Orthopeadics, Rheumatology and Musculosceletal Sciences, University of Oxford, Oxford, OX3 7HE, UK.
Health Qual Life Outcomes. 2016 Jan 27;14:15. doi: 10.1186/s12955-016-0417-7.
The aim of this study was to assess the psychometric properties of the EQ-5D-3 L, the SF-12 v2 and its preference based derivative the SF-6D, and the St Georges Respiratory Questionnaire (SGRQ), in patients diagnosed with Acute Respiratory Distress Syndrome (ARDS).
Data from the Oscillation in ARDS (OSCAR) randomised unblinded clinical trial of 795 patients diagnosed with ARDS provided the foundation of this secondary psychometric analysis. The three source patient reported outcome measures (PROMs) (EQ-5D-3 L, SF-12 and SGRQ) were collected at both 6 and 12 months post randomisation. All measures were tested for acceptability, reliability, internal consistency, validity and responsiveness. Data from responders at 6 months was used to test for acceptability, reliability, known groups validity and internal responsiveness. Data from patients who responded at both 6 and 12 months was used to test for convergent validity and external responsiveness.
Rates of response at both 6 and 12 months post randomisation were 89.88 % for the EQ-5D-3 L, 77.38 % for the SF-6D, 71.43 % for both the physical and mental components of the SF-12 and 38.10 % for the SGRQ. All measures had a Cronbach's Alpha statistic higher than 0.7. For known group's validity, there was no difference in mean summary or utility scores between known groups for all PROMs with minimal effect sizes. All three source measures showed strong convergent and discriminant validity. There was consistent evidence that the SF-6D is an empirically valid and efficient alternative to the EQ-5D-3 L. The EQ-5D-3 L and SGRQ were more responsive compared to the SF-12 and SF-6D with the EQ-5D-3 L generating greater effect sizes than the SGRQ.
The PROMs explored in this study displayed varying psychometric properties in the context of ARDS. Further research should focus on shortening the SGRQ whilst still maintaining its psychometric properties and mapping between the SGRQ and preference-based measures for future application within economic evaluations of respiratory focused interventions. The selection ofa preferred PROM for evaluative studies within the ARDS context should ultimately depend on the relative importance placed on individual psychometric properties and the importance placed on generation of health utilities for economic evaluation purposes.
本研究旨在评估急性呼吸窘迫综合征（ARDS）患者中EQ-5D-3L、SF-12 v2及其基于偏好的衍生工具SF-6D以及圣乔治呼吸问卷（SGRQ）的心理测量特性。
ARDS振荡（OSCAR）随机非盲临床试验中795例ARDS确诊患者的数据为本次二次心理测量分析提供了基础。三项源患者报告结局指标（PROMs）（EQ-5D-3L、SF-12和SGRQ）在随机分组后6个月和12个月时收集。所有指标均进行了可接受性、信度、内部一致性、效度和反应度测试。6个月时应答者的数据用于测试可接受性、信度、已知组效度和内部反应度。6个月和12个月均有应答的患者的数据用于测试收敛效度和外部反应度。
随机分组后6个月和12个月时，EQ-5D-3L的应答率为89.88%，SF-6D为77.38%，SF-12的身体和心理分量表均为71.43%，SGRQ为38.10%。所有指标的Cronbach's Alpha统计量均高于0.7。对于已知组效度，所有PROMs的已知组间平均汇总或效用得分无差异，效应量极小。所有三项源指标均显示出较强的收敛效度和区分效度。有一致证据表明，SF-6D是EQ-5D-3L在经验上有效且高效的替代工具。与SF-12和SF-6D相比，EQ-5D-3L和SGRQ的反应度更高，EQ-5D-3L产生的效应量大于SGRQ。
本研究中探索的PROMs在ARDS背景下表现出不同的心理测量特性。未来研究应聚焦于缩短SGRQ，同时仍保持其心理测量特性，并明确SGRQ与基于偏好的指标之间的映射关系，以便在以呼吸为重点的干预措施的经济评估中应用。在ARDS背景下的评估研究中，选择首选的PROM最终应取决于对个体心理测量特性的相对重视程度以及对为经济评估目的生成健康效用的重视程度。
