Section for Ethics and Health Economics, Department of Global Public Health and Primary Care, Faculty of Health Sciences, University of Bergen, 5020, Bergen, Norway.
Dental Biomaterials Adverse Reaction Unit, NORCE Norwegian Research Centre AS, Bergen, Norway.
Health Qual Life Outcomes. 2021 Apr 17;19(1):125. doi: 10.1186/s12955-021-01762-4.
BACKGROUND: Evidence of health utility changes in patients who suffer from longstanding health complaints attributed to dental amalgam fillings are limited. The change in health utility outcomes enables calculating quality-adjusted life-year (QALY) and facilitates the comparison with other health conditions. The purpose of this study was to estimate the validity and responsiveness of the EQ-5D-5L and SF-6D utilities following removal of dental amalgam fillings in patients with health complaints attributed to their amalgam fillings, and examine the ability of these instruments to detect minimally important changes over time. METHODS: Patients with medically unexplained physical symptoms, which they attributed to dental amalgam restorations, were recruited to a prospective cohort study in Norway. Two health state utility instruments, EQ-5D-5L and SF-6D, as well as self-reported general health complaints (GHC-index) and visual analogue scale (EQ-VAS) were administered to all patients (n = 32) at baseline and at follow-up. The last two were used as criteria measures. Concurrent and predictive validities were examined using correlation coefficients. Responsiveness was assessed by the effect size (ES), standardized response mean (SRM), and relative efficiency. Minimally important change (MIC) was examined by distribution and anchor-based approaches. RESULTS: Concurrent validity of the EQ-5D-5L was similar to that of SF-6D utility. EQ-5D-5L was more responsive than SF-6D: the ES were 0.73 and 0.58 for EQ-5D-5L and SF-6D, respectively; SRM were 0.76 and 0.67, respectively. EQ-5D-5L was more efficient than SF-6D in detecting changes, but both were less efficient compared to criteria-based measures. The estimated MIC of EQ-5D-5L value set was 0.108 and 0.118 based on distribution and anchor-based approaches, respectively. The corresponding values for SF-6D were 0.048 and 0.064, respectively. CONCLUSIONS: In patients with health complaints attributed to dental amalgam undergoing amalgam removal, both EQ-5D-5L and SF-6D showed reasonable concurrent and predictive validity and acceptable responsiveness. The EQ-5D-5L utility appears to be more responsive compared to SF-6D. Trial registration The research was registered at ClinicalTrials.gov., NCT01682278. Registered 10 September 2012, https://clinicaltrials.gov/ct2/show/NCT01682278 .
背景：长期患有归因于银汞合金填充物的健康问题的患者的健康效用变化的证据有限。健康效用结果的变化可以计算质量调整生命年（QALY），并有助于与其他健康状况进行比较。本研究的目的是估计在归因于银汞合金填充物的健康问题的患者中去除银汞合金填充物后，EQ-5D-5L 和 SF-6D 效用的有效性和反应性，并检查这些工具随时间检测最小重要变化的能力。
方法：挪威招募了患有医学上无法解释的身体症状的患者，这些症状归因于牙科汞合金修复体，这些患者参与了一项前瞻性队列研究。所有患者（n=32）在基线和随访时均接受了两种健康状态效用工具（EQ-5D-5L 和 SF-6D）以及自我报告的一般健康投诉（GHC-index）和视觉模拟量表（EQ-VAS）。后两者用作标准措施。使用相关系数检查同时和预测有效性。通过效应量（ES）、标准化反应均值（SRM）和相对效率评估反应性。通过分布和基于锚的方法检查最小重要变化（MIC）。
结果：EQ-5D-5L 的同时效性与 SF-6D 效用相似。EQ-5D-5L 比 SF-6D 更具反应性：EQ-5D-5L 的 ES 分别为 0.73 和 0.58，SF-6D 的 ES 分别为 0.76 和 0.67。EQ-5D-5L 在检测变化方面比 SF-6D 更有效，但与基于标准的措施相比，两者都效率较低。基于分布和基于锚的方法，EQ-5D-5L 值集的估计 MIC 分别为 0.108 和 0.118。SF-6D 的相应值分别为 0.048 和 0.064。
结论：在接受汞合金去除治疗的归因于汞合金的健康问题患者中，EQ-5D-5L 和 SF-6D 均表现出合理的同时效性和预测效性以及可接受的反应性。与 SF-6D 相比，EQ-5D-5L 似乎更具反应性。
试验注册：该研究在 ClinicalTrials.gov 上注册，NCT01682278。2012 年 9 月 10 日注册，https://clinicaltrials.gov/ct2/show/NCT01682278。
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