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成人改良脊柱侧凸研究学会疗效评估工具的研究:效度、信度及区分能力

Studies in the modified Scoliosis Research Society Outcomes Instrument in adults: validation, reliability, and discriminatory capacity.

作者信息

Berven Sigurd, Deviren Vedat, Demir-Deviren Sibel, Hu Serena S, Bradford David S

机构信息

Department of Orthopaedic Surgery, University of California, San Francisco, CA, USA.

出版信息

Spine (Phila Pa 1976). 2003 Sep 15;28(18):2164-9; discussion 2169. doi: 10.1097/01.BRS.0000084666.53553.D6.

Abstract

STUDY DESIGN

Observational study of patients with scoliosis and matched controls.

OBJECTIVES

To determine the validity and reliability of the modified Scoliosis Research Society Outcomes Instrument (SRS-22) for use in the assessment of deformity in adults. To demonstrate the discriminate validity of the SRS-22 in differentiating between affected and unaffected adults.

SUMMARY OF BACKGROUND DATA

Spinal deformity has an important impact on the general health status of adults. The magnitude of this impact has been difficult to measure and reported variably in the literature. The development of disease-specific outcomes tools permits improved sensitivity and specificity in measuring the patient's self-assessment of health status. An instrument for measuring disease-specific health status in adults with scoliosis has not been validated.

MATERIALS AND METHODS

Observational study comparing the health status of adults affected by scoliosis and unaffected controls, matched for age, gender, and socioeconomic status. Pearson correlation analysis was used to determine the relationship of each domain within the SRS-22 and SF-36 with radiographic parameters including sagittal balance, coronal balance, and major curve correction. Discriminate validity of the modified SRS instrument was determined by a comparison of means between affected and unaffected cohorts. The validation of the SRS-22 was determined by criterion validity, using correlation analysis with comparable domains of the SF-36. The reliability of the SRS-22 was demonstrated using test-retest parity and Cronbach's alpha test for internal consistency.

RESULTS

One hundred eighty adults were included in the study, 146 with scoliosis and 34 without. Adults with scoliosis scored significantly lower than unaffected controls on every domain of the SRS-22 and the SF-36. The floor and ceiling effect of the SRS-22 were less than observed in the SF-36 instrument. Pearson correlation analysis demonstrated no significant correlation between any radiographic process measure and any specific domain within the SRS-22 or the SF-36 (r < 0.25). Comparison of similar domains in the SRS-22 and the SF-36 demonstrates high correlation between the instruments. Test-retest analysis similarly demonstrates a high degree of reproducibility in each domain (r = 0.83-0.94). Cronbach's alpha test of internal consistency within each domain demonstrates intercorrelation values greater than 0.75 within each domain of the SRS-22.

CONCLUSIONS

Adult scoliosis has a significant and measurable impact on affected patients compared with controls. There is a poor correlation between radiographic parameters of outcome and patient self-assessment of health status. The SRS-22 is a reliable instrument in adults as demonstrated by a high degree of internal consistency and reproducibility. The SRS-22 is a valid instrument for use in adult deformity as demonstrated by the criterion validity assessment with the SF-36. The study supports the use of the SRS-22 in the adult spinal deformity population.

摘要

研究设计

对脊柱侧弯患者及匹配的对照组进行观察性研究。

目的

确定改良版脊柱侧弯研究学会疗效评估工具(SRS-22)用于评估成人脊柱畸形的有效性和可靠性。证明SRS-22在区分受影响和未受影响的成年人方面的区分效度。

背景数据总结

脊柱畸形对成年人的总体健康状况有重要影响。这种影响的程度难以衡量,文献中的报道也各不相同。疾病特异性结局工具的开发提高了测量患者健康状况自我评估的敏感性和特异性。一种用于测量成人脊柱侧弯疾病特异性健康状况的工具尚未得到验证。

材料与方法

观察性研究,比较受脊柱侧弯影响的成年人与年龄、性别和社会经济地位相匹配的未受影响对照组的健康状况。采用Pearson相关分析确定SRS-22和SF-36中每个领域与包括矢状面平衡、冠状面平衡和主弯矫正在内的影像学参数之间的关系。通过比较受影响和未受影响队列的均值来确定改良版SRS工具的区分效度。使用与SF-36可比领域的相关分析,通过效标效度来确定SRS-22的效度。使用重测一致性和Cronbach's alpha检验来证明SRS-22的内部一致性,从而验证其可靠性。

结果

该研究纳入了180名成年人,其中146名患有脊柱侧弯,34名未患。患有脊柱侧弯的成年人在SRS-22和SF-36的每个领域的得分均显著低于未受影响的对照组。SRS-22的地板效应和天花板效应低于SF-36工具中观察到的情况。Pearson相关分析表明,任何影像学测量指标与SRS-22或SF-36中的任何特定领域之间均无显著相关性(r < 0.25)。SRS-22和SF-36中相似领域的比较表明,这两种工具之间具有高度相关性。重测分析同样表明每个领域具有高度的可重复性(r = 0.83 - 0.94)。SRS-22每个领域的内部一致性Cronbach's alpha检验表明,每个领域内的相互关联值大于0.75。

结论

与对照组相比,成人脊柱侧弯对受影响患者有显著且可测量的影响。结局的影像学参数与患者健康状况自我评估之间的相关性较差。SRS-22具有高度的内部一致性和可重复性,证明其在成年人中是一种可靠的工具。通过与SF-36的效标效度评估表明,SRS-22是用于评估成人脊柱畸形的有效工具。该研究支持在成人脊柱畸形人群中使用SRS-22。

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