Quantify Research, Stockholm, Sweden.
Osteoporos Int. 2013 Jul;24(7):1991-9. doi: 10.1007/s00198-012-2237-x. Epub 2013 Apr 27.
This study uses data from a previously published randomised trial where balloon kyphoplasty was compared to non-surgical management. Of the improved overall quality of life, 60 % was caused by decreased pain. However, ignoring other dimensions of quality of life would underestimate the procedure's effect.
Acute back pain has been viewed as the most important factor lowering quality of life (QoL) for patients suffering vertebral fractures. The objective of this study was to quantify the impact of different health dimensions on overall QoL using patient-reported outcome measurements (PROMs) collected in Fracture Reduction Evaluation (FREE) trial.
The analysis was based on patients included in the 2-year-long randomised controlled FREE trial studying the efficacy and safety of balloon kyphoplasty procedure (BKP) compared to non-surgical management (NSM). The PROMs included were EQ-5D, Short Form (SF)-36, visual analogue scale (VAS) pain and the Roland-Morris Disability Questionnaire (RMDQ). The health dimensional contribution to the overall QoL improvements was analysed by isolating the impact of each dimension on QoL in the SF-36 and EQ-5D, respectively. A correlation analysis of the QoL improvement was performed to investigate the relationships between the four instruments.
Changes in pain explained 60 % of the quality-adjusted life years (QALY) gained in BKP vs. NSM followed by self-care (17 %), mobility (16 %) and usual activities (10 %) (EQ-5D). Health dimensions capturing the mental state had little impact on the QALY gained. The SF-36 dimensional analysis showed similar results. The correlation analysis showed that the correlation between VAS pain, RMDQ and QALY improvement was fairly weak.
Changes in the pain dimension of health are the most important drivers for changes of overall QoL in patients treated with BKP or NSM. However, ignoring the impact of other dimensions would lead to an underestimation of the actual improvement in overall QoL.
本研究使用了先前发表的一项随机试验的数据，该试验比较了球囊椎体后凸成形术与非手术治疗。整体生活质量的改善中，有 60%是由疼痛减轻引起的。然而，忽略生活质量的其他方面会低估该手术的效果。
急性背痛被认为是导致椎体骨折患者生活质量（QoL）下降的最重要因素。本研究的目的是使用 Fracture Reduction Evaluation（FREE）试验中收集的患者报告结局测量（PROM）来量化不同健康维度对整体 QoL 的影响。
该分析基于纳入为期 2 年的随机对照 FREE 试验的患者，该试验研究了球囊椎体后凸成形术（BKP）与非手术治疗（NSM）相比的疗效和安全性。纳入的 PROM 包括 EQ-5D、Short Form（SF）-36、视觉模拟评分（VAS）疼痛和 Roland-Morris 残疾问卷（RMDQ）。通过分别隔离每个维度对 SF-36 和 EQ-5D 中 QoL 的影响，分析健康维度对整体 QoL 改善的贡献。对 QoL 改善进行相关分析，以调查四种仪器之间的关系。
BKP 与 NSM 相比，疼痛的变化解释了 QALY 获益的 60%（EQ-5D），其次是自理（17%）、活动能力（16%）和日常活动（10%）。捕捉精神状态的健康维度对 QALY 获益的影响很小。SF-36 维度分析得出了类似的结果。相关分析表明，VAS 疼痛、RMDQ 和 QALY 改善之间的相关性相当弱。
治疗 BKP 或 NSM 患者健康的疼痛维度变化是整体 QoL 变化的最重要驱动因素。然而，忽略其他维度的影响会导致对整体 QoL 实际改善的低估。
