Graduate School, Beijing University of Chinese Medicine, Beijing, 100029, China.
Traditional Chinese Medicine Department of Rheumatism, China-Japan Friendship Hospital, Beijing, 100029, China.
Health Qual Life Outcomes. 2022 Jul 30;20(1):116. doi: 10.1186/s12955-022-02026-5.
Patients who suffered from ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA) often have poor quality of life (QoL) and there has been a substantial increase in research on acceptable questionnaires for assessment of QoL. This systematic review aims at examining the validity and reliability of QoL questionnaires in patients with AS/nr-axSpA.
Randomized controlled trials (RCTs), cohort trials, and cross-sectional trails were retrieved by searching seven databases. Primary outcomes included test-retest reliability and construct validity. Secondary outcomes included internal consistency, structural validity, responsiveness and so on. Data extraction and analyses were conducted according to the Cochrane standards. The Agency for Healthcare Research and Quality (AHRQ) checklists was used to assess the risk of bias for each included study. We used the Consensus-based Standards for the Selection of Health Status Measurement Instruments (COSMIN) to assess the methodological quality and measurement property of included instruments. The quality of evidence on pre-specified outcomes were assessed by the Grades of Recommendations, Development and Evaluation (GRADE) approach.
22 publications containing 10 self-rating instruments were included in this study. Most studies were cross-sectional in design and a total of 3,085 participants were enrolled. 19 studies had moderate to high test-retest reliability. Cronbach's alpha (α) Coefficients were generally high (0.79-0.97) for overall scales. The ankylosing spondylitis quality of life (ASQOL) and evaluation of ankylosing spondylitis quality of life (EASi-QoL) questionnaires showed the strongest measurement properties in high-quality studies. The correlation coefficient for test-retest reliability of the ASQOL questionnaire was 0.85 (95% CI 0.80 to 0.89). The pooled Cronbach's α coefficients of the ASQOL questionnaire and the EASi-QoL questionnaire were high. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional Index (BASFI) were considered as two validity criteria. For the ASQOL and EASi-QoL questionnaire, pooled convergent validity associations with BASDAI and BASFI were low to strong (0.24-0.81).
This study indicated acceptable reliability and stability of included QoL questionnaires. The ASQOL and the EASi-QoL questionnaires are validated and reliable disease-specific questionnaires for the assessment of QoL in patients with AS/nr-axSpA.
患有强直性脊柱炎（AS）或非放射学中轴型脊柱关节炎（nr-axSpA）的患者生活质量（QoL）往往较差，并且已经有大量研究关注可用于评估 QoL 的可接受问卷。本系统评价旨在检查 AS/nr-axSpA 患者 QoL 问卷的有效性和可靠性。
通过搜索七个数据库，检索随机对照试验（RCT）、队列研究和横断面研究。主要结局包括重测信度和结构效度。次要结局包括内部一致性、结构效度、反应度等。根据 Cochrane 标准进行数据提取和分析。使用美国医疗保健研究与质量局（AHRQ）检查表评估每个纳入研究的偏倚风险。我们使用健康状况测量仪器选择共识标准（COSMIN）来评估纳入工具的方法学质量和测量特性。通过推荐、制定和评估分级（GRADE）方法评估预先指定结局的证据质量。
本研究纳入了 22 篇包含 10 种自评量表的文献。大多数研究为横断面设计，共纳入 3085 名参与者。19 项研究具有中等到高度的重测信度。总体量表的 Cronbach's alpha（α）系数通常较高（0.79-0.97）。强直性脊柱炎生活质量问卷（ASQOL）和强直性脊柱炎生活质量评估问卷（EASi-QoL）在高质量研究中表现出最强的测量特性。ASQOL 问卷重测信度的相关系数为 0.85（95%CI 0.80 至 0.89）。ASQOL 问卷和 EASi-QoL 问卷的合并 Cronbach's α 系数较高。 Bath 强直性脊柱炎疾病活动指数（BASDAI）和 Bath 强直性脊柱炎功能指数（BASFI）被认为是两个有效性标准。对于 ASQOL 和 EASi-QoL 问卷，与 BASDAI 和 BASFI 的合并相关性具有低至中度（0.24-0.81）。
本研究表明纳入的 QoL 问卷具有可接受的信度和稳定性。ASQOL 和 EASi-QoL 问卷是评估 AS/nr-axSpA 患者 QoL 的经过验证和可靠的疾病特异性问卷。
