Purpose

There is a wide selection of instruments and questionnaires available, but many are time consuming in their administration, for patients, practitioners and researchers alike. The Core Outcome Measures Index (COMI) is a short, self-administrated, multidimensional instrument translated into several languages that covers five domains recommended in the assessment of outcome in patients with low-back pain. The purpose of this study was to cross-culturally adapt the COMI from English to Swedish and to test the face and construct validity and reproducibility of its results in patients with low-back pain.

Methods

Participants (n = 102) were included from primary and secondary care. The participants reported moderate pain and disability levels. All participants filled in the COMI, the Oswestry Disability Index and the EQ5D at baseline. Forty-nine filled in the COMI again after 7 days for the reproducibility part of the study.

Results

The instrument was successfully forward and back-translated. In the validation process, there were low floor/ceiling effects, with the exception of the symptom-specific well-being (floor) and work disability (ceiling) items. The specific COMI domains and whole score correlated significantly with the chosen reference scale scores to the hypothesised extent (Rho 0.30–0.60 and > 0.60 respectively). COMI reached ICC 0.63 (95% CI 0.42–0.77) in the reproducibility test and the separate items, ICC 0.41–0.78.

Conclusions

The Swedish COMI shows acceptable psychometric properties and is thus suitable to use as a short instrument for measuring important domains in patients with low-back pain. A future study should investigate the instrument's sensitivity to measure change after treatment.

Graphic abstract

These slides can be retrieved under Electronic Supplementary Material.

中文翻译：

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跨文化适应和瑞典语版《核心结果指标》对低腰痛的验证。

目的

有多种工具和问卷可供选择，但是对于患者，从业人员和研究人员而言，许多工具和问卷在管理上都很耗时。核心成果评估指数（COMI）是一种简短的，自我管理的多维工具，已翻译成多种语言，涵盖了腰背痛患者评估结局时推荐的五个领域。这项研究的目的是使COMI从英语到瑞典语跨文化适应，并测试脸部，并在腰背痛患者中构建其结果的有效性和可重复性。

方法

参加者（n  = 102）来自初级和二级保健。参与者报告中度疼痛和残疾水平。所有参与者均在基线时填写了COMI，Oswestry残疾指数和EQ5D。7天后在研究的可重复性部分中再次填充COMI。

结果

仪器已成功地向前和向后翻译。在验证过程中，地板/天花板效果低，除了症状特定的幸福感（地板）和工作障碍（天花板）以外。特定的COMI域和整体评分与所选参考量表评分在假设的范围内显着相关（分别为Rho 0.30–0.60和> 0.60）。在重现性测试中，COMI达到ICC 0.63（95％CI 0.42–0.77），而单独的项目ICC 0.41-0.78。

结论

瑞典的COMI具有可接受的心理测量特性，因此适合用作测量腰背痛患者重要部位的简短仪器。未来的研究应调查该仪器在治疗后测量变化的敏感性。

图形摘要

这些幻灯片可以在电子补充材料下找到。