The Division of Orthopaedic Surgery, Department of Surgery, and the Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario.
Can J Surg. 2013 Oct;56(5):E114-20. doi: 10.1503/cjs.004312.
Assessing fracture healing in clinical trials is subjective. The new Function IndeX for Trauma (FIX-IT) score provides a simple, standardized approach to assess weight-bearing and pain in patients with lower extremity fractures. We conducted an initial validation of the FIX-IT score.
We conducted a cross-sectional study involving 50 patients with lower extremity fractures across different stages of healing to evaluate the reliability and preliminary validity of the FIX-IT score. Patients were independently examined by 2 orthopedic surgeons, 1 orthopedic fellow, 2 orthopedic residents and 2 research coordinators. Patients also completed the Short Form-36 version 2 (SF-36v2) questionnaire, and convergent validity was tested with the SF-36v2.
For interrater reliability, the intraclass correlation coefficients ranged from 0.637 to 0.915. The overall interrater reliability for the total FIX-IT score was 0.879 (95% confidence interval 0.828-0.921). The correlations between the FIX-IT score and the SF-36 ranged from 0.682 to 0.770 for the physical component summary score, from 0.681 to 0.758 for the physical function subscale, and from 0.677 to 0.786 for the role-physical subscale.
The FIX-IT score had high interrater agreement across multiple examiners. Moreover, FIX-IT scores correlate with the physical scores of the SF-36. Although additional research is needed to fully validate FIX-IT, our results suggest the potential for FIX-IT to be a reliable adjunctive clinician measure to evaluate healing in lower extremity fractures.
Diagnostic Study Level I.
临床试验中评估骨折愈合情况具有主观性。新型创伤功能指数（Function IndeX for Trauma，FIX-IT）评分提供了一种简单、标准化的方法，用于评估下肢骨折患者的负重和疼痛情况。我们对 FIX-IT 评分进行了初步验证。
我们进行了一项横断面研究，纳入了 50 例不同愈合阶段的下肢骨折患者，以评估 FIX-IT 评分的可靠性和初步有效性。由 2 名骨科医生、1 名骨科住院医师、2 名骨科住院医师和 2 名研究协调员对患者进行独立检查。患者还完成了简明健康状况调查问卷 36 版（Short Form-36 version 2，SF-36v2）问卷，并用 SF-36v2 测试了其收敛效度。
对于组内一致性，组内相关系数范围为 0.637 至 0.915。总 FIX-IT 评分的总体组内一致性为 0.879（95%置信区间为 0.828-0.921）。FIX-IT 评分与 SF-36 的相关性在生理成分综合评分中为 0.682 至 0.770，在生理功能子量表中为 0.681 至 0.758，在身体角色子量表中为 0.677 至 0.786。
FIX-IT 评分在多名检查者之间具有较高的组内一致性。此外，FIX-IT 评分与 SF-36 的生理评分相关。尽管还需要进一步的研究来充分验证 FIX-IT，但我们的结果表明，FIX-IT 有可能成为一种可靠的辅助临床医生评估下肢骨折愈合情况的工具。
诊断研究，I 级。
