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腰痛患者的临床评估研究
 
硕士研究生:刘 
      师:罗卓荆   教授
第四军医大学西京医院骨科,西安 710032
 
 
研究背景 腰痛(LBP)是骨科常见的症状之一。产生腰痛的病因和机制有很多种。腰痛患者的生活质量受到疾病的巨大影响。临床上,为了更好的评估腰痛患者的病,选择合适的治疗手段和比较治疗效果,制定出了多种以患者生活质量为中心的问卷调查表。由于这些量表多为英语,并针对欧美患者设计。所以,正确使用这些评估工具的前提之一是将其有效合理地翻译并改编成本国语言。
目的Oswestry功能障碍指数(Oswestry Disability Index, ODI)翻译和改编为简体中文版(simplified Chinese version of the ODI, SCODI),并进一步在实际临床中来评估中国腰痛患者的病情程度。
方法首先,由英语专业的本国人员和英美籍留学生共同将最新英文版本的ODI2.1a)按照国际上标准的参考原则翻译成中文,并进行不同语种之间交叉式翻译,目的是在最大程度上降低不同语种所带来的理解差异。然后,在40例门诊腰痛患者中试用SCODI,证明翻译改编工作的可靠性和正确性;最后,进行临床大样本研究,对179例下腰痛患者(包括140例门诊病人和39例病房病人)分别进行SCODI36条目简明量表(Short Form 36, SF-36)和疼痛视觉模拟评分(Visual Analog Scale, VAS)的评价及问卷调查。分析各调查表评分结果及之间的相关性,计算出进过改编简体中文版ODI的效度和信度。
结果经过一个标准的四部翻译改编过程,我们得出了简体中文试用版ODI。在随后的临床试用阶段中,40例门诊患者表示均能正确地理解SCODI。在最后的大样本研究中,内部一致性Cronbach’s alpha0.93,信度测验的同类相关系数(intraclass correlation coefficient, ICC)结果为0.99。效度测验中SCODISF-368个维度密切相关,尤其是在躯体功能方面(r= 0.78, p<0.001);与VAS在一定程度上相关(r=0.69, p<0.001)。通过比较本次试验和国外同类研究中的ODISF36VAS的相关性结果,发现SCODI很好的保持了原ODI的评估能力。同时,通过比较门诊和病房待手术患者组,急性和慢性腰痛患者组之间各量表评分的差异,总结出了一些对腰痛患者临床诊断、治疗及术后预测有帮助的结论。
结论 通过本次针对ODI的改编和效度信度测量试验,我们得到了SCODI。经过临床实际测试,我们验证了SCODI在保证原版本有效性的基础上,能够正确的被中国患者所理解。本次试验一方面为我国临床工作中广泛开展腰痛患者病情评估提供了有效的工具,另一方面对将来我国腰痛患者进一步临床研究有重要意义。
 
关键词腰痛;Oswestry功能障碍指数;效度;信度;患者评估;健康质量
 
 
 
Objectives: The objective of this study was to translate and adapt the Oswestry Disability Index (ODI) into simplified Chinese and to then validate its use in Chinese patients with low back pain (LBP).
Methods: Translation and cross-cultural adaptation of the latest version of the ODI (2.1a) were performed following instructions from the published international guidelines. The translation procedure included forward translation, back translation, and a discussion among experts. The pre-final version was tested in 40 outpatients with LBP. Then, 179 patients with LBP, including 140 outpatients and 39 inpatients, participated in the final test. They finished the SCODI, the Short Form 36, and the Visual Analog Scale (VAS). Those 39 inpatients also finished a second ODI questionnaire within 24 hours. Lastly, the SCODI and TCODI were tested in another 25 inpatients for comparison.
Results: All of the patients in the pre-final test understood the simplified Chinese version correctly. In the final test, Cronbach’s alpha for internal consistency was 0.93. A very high intraclass correlation coefficient was observed (ICC= 0.99) in the test-retest group. The SCODI showed a significant correlation with the eight subscales of the Short Form 36, especially in physical functioning (r= 0.78, p<0.001). There was a moderate correlation between the ODI scores and the VAS (r=0.69, p<0.001). A significant difference in the mean score was demonstrated between the SCODI and the TCODI. Patients who participated in the comparison test all agreed that the SCODI was easier to understand than the TCODI.
Conclusion: The results showed that the translation and adaptation were successful. The SCODI has proven to be valid and reliable when used in the simplified Chinese speaking population.

KEY WORDS: Low back pain, Oswestry disability index, reliability, validitypatients assessmentQuitily of life

腰痛患者的临床评估研究
 
硕士研究生:刘 
      师:罗卓荆   教授
第四军医大学西京医院骨科,西安 710032
 
 
研究背景 腰痛(LBP)是骨科常见的症状之一。产生腰痛的病因和机制有很多种。腰痛患者的生活质量受到疾病的巨大影响。临床上,为了更好的评估腰痛患者的病,选择合适的治疗手段和比较治疗效果,制定出了多种以患者生活质量为中心的问卷调查表。由于这些量表多为英语,并针对欧美患者设计。所以,正确使用这些评估工具的前提之一是将其有效合理地翻译并改编成本国语言。
目的Oswestry功能障碍指数(Oswestry Disability Index, ODI)翻译和改编为简体中文版(simplified Chinese version of the ODI, SCODI),并进一步在实际临床中来评估中国腰痛患者的病情程度。
方法首先,由英语专业的本国人员和英美籍留学生共同将最新英文版本的ODI2.1a)按照国际上标准的参考原则翻译成中文,并进行不同语种之间交叉式翻译,目的是在最大程度上降低不同语种所带来的理解差异。然后,在40例门诊腰痛患者中试用SCODI,证明翻译改编工作的可靠性和正确性;最后,进行临床大样本研究,对179例下腰痛患者(包括140例门诊病人和39例病房病人)分别进行SCODI36条目简明量表(Short Form 36, SF-36)和疼痛视觉模拟评分(Visual Analog Scale, VAS)的评价及问卷调查。分析各调查表评分结果及之间的相关性,计算出进过改编简体中文版ODI的效度和信度。
结果经过一个标准的四部翻译改编过程,我们得出了简体中文试用版ODI。在随后的临床试用阶段中,40例门诊患者表示均能正确地理解SCODI。在最后的大样本研究中,内部一致性Cronbach’s alpha0.93,信度测验的同类相关系数(intraclass correlation coefficient, ICC)结果为0.99。效度测验中SCODISF-368个维度密切相关,尤其是在躯体功能方面(r= 0.78, p<0.001);与VAS在一定程度上相关(r=0.69, p<0.001)。通过比较本次试验和国外同类研究中的ODISF36VAS的相关性结果,发现SCODI很好的保持了原ODI的评估能力。同时,通过比较门诊和病房待手术患者组,急性和慢性腰痛患者组之间各量表评分的差异,总结出了一些对腰痛患者临床诊断、治疗及术后预测有帮助的结论。
结论 通过本次针对ODI的改编和效度信度测量试验,我们得到了SCODI。经过临床实际测试,我们验证了SCODI在保证原版本有效性的基础上,能够正确的被中国患者所理解。本次试验一方面为我国临床工作中广泛开展腰痛患者病情评估提供了有效的工具,另一方面对将来我国腰痛患者进一步临床研究有重要意义。
 
关键词腰痛;Oswestry功能障碍指数;效度;信度;患者评估;健康质量
 
 
 
Objectives: The objective of this study was to translate and adapt the Oswestry Disability Index (ODI) into simplified Chinese and to then validate its use in Chinese patients with low back pain (LBP).
Methods: Translation and cross-cultural adaptation of the latest version of the ODI (2.1a) were performed following instructions from the published international guidelines. The translation procedure included forward translation, back translation, and a discussion among experts. The pre-final version was tested in 40 outpatients with LBP. Then, 179 patients with LBP, including 140 outpatients and 39 inpatients, participated in the final test. They finished the SCODI, the Short Form 36, and the Visual Analog Scale (VAS). Those 39 inpatients also finished a second ODI questionnaire within 24 hours. Lastly, the SCODI and TCODI were tested in another 25 inpatients for comparison.
Results: All of the patients in the pre-final test understood the simplified Chinese version correctly. In the final test, Cronbach’s alpha for internal consistency was 0.93. A very high intraclass correlation coefficient was observed (ICC= 0.99) in the test-retest group. The SCODI showed a significant correlation with the eight subscales of the Short Form 36, especially in physical functioning (r= 0.78, p<0.001). There was a moderate correlation between the ODI scores and the VAS (r=0.69, p<0.001). A significant difference in the mean score was demonstrated between the SCODI and the TCODI. Patients who participated in the comparison test all agreed that the SCODI was easier to understand than the TCODI.
Conclusion: The results showed that the translation and adaptation were successful. The SCODI has proven to be valid and reliable when used in the simplified Chinese speaking population.

KEY WORDS: Low back pain, Oswestry disability index, reliability, validitypatients assessmentQuitily of life

腰痛患者的临床评估研究
 
硕士研究生:刘 
      师:罗卓荆   教授
第四军医大学西京医院骨科,西安 710032
 
 
研究背景 腰痛(LBP)是骨科常见的症状之一。产生腰痛的病因和机制有很多种。腰痛患者的生活质量受到疾病的巨大影响。临床上,为了更好的评估腰痛患者的病,选择合适的治疗手段和比较治疗效果,制定出了多种以患者生活质量为中心的问卷调查表。由于这些量表多为英语,并针对欧美患者设计。所以,正确使用这些评估工具的前提之一是将其有效合理地翻译并改编成本国语言。
目的Oswestry功能障碍指数(Oswestry Disability Index, ODI)翻译和改编为简体中文版(simplified Chinese version of the ODI, SCODI),并进一步在实际临床中来评估中国腰痛患者的病情程度。
方法首先,由英语专业的本国人员和英美籍留学生共同将最新英文版本的ODI2.1a)按照国际上标准的参考原则翻译成中文,并进行不同语种之间交叉式翻译,目的是在最大程度上降低不同语种所带来的理解差异。然后,在40例门诊腰痛患者中试用SCODI,证明翻译改编工作的可靠性和正确性;最后,进行临床大样本研究,对179例下腰痛患者(包括140例门诊病人和39例病房病人)分别进行SCODI36条目简明量表(Short Form 36, SF-36)和疼痛视觉模拟评分(Visual Analog Scale, VAS)的评价及问卷调查。分析各调查表评分结果及之间的相关性,计算出进过改编简体中文版ODI的效度和信度。
结果经过一个标准的四部翻译改编过程,我们得出了简体中文试用版ODI。在随后的临床试用阶段中,40例门诊患者表示均能正确地理解SCODI。在最后的大样本研究中,内部一致性Cronbach’s alpha0.93,信度测验的同类相关系数(intraclass correlation coefficient, ICC)结果为0.99。效度测验中SCODISF-368个维度密切相关,尤其是在躯体功能方面(r= 0.78, p<0.001);与VAS在一定程度上相关(r=0.69, p<0.001)。通过比较本次试验和国外同类研究中的ODISF36VAS的相关性结果,发现SCODI很好的保持了原ODI的评估能力。同时,通过比较门诊和病房待手术患者组,急性和慢性腰痛患者组之间各量表评分的差异,总结出了一些对腰痛患者临床诊断、治疗及术后预测有帮助的结论。
结论 通过本次针对ODI的改编和效度信度测量试验,我们得到了SCODI。经过临床实际测试,我们验证了SCODI在保证原版本有效性的基础上,能够正确的被中国患者所理解。本次试验一方面为我国临床工作中广泛开展腰痛患者病情评估提供了有效的工具,另一方面对将来我国腰痛患者进一步临床研究有重要意义。
 
关键词腰痛;Oswestry功能障碍指数;效度;信度;患者评估;健康质量
 
 
 
Objectives: The objective of this study was to translate and adapt the Oswestry Disability Index (ODI) into simplified Chinese and to then validate its use in Chinese patients with low back pain (LBP).
Methods: Translation and cross-cultural adaptation of the latest version of the ODI (2.1a) were performed following instructions from the published international guidelines. The translation procedure included forward translation, back translation, and a discussion among experts. The pre-final version was tested in 40 outpatients with LBP. Then, 179 patients with LBP, including 140 outpatients and 39 inpatients, participated in the final test. They finished the SCODI, the Short Form 36, and the Visual Analog Scale (VAS). Those 39 inpatients also finished a second ODI questionnaire within 24 hours. Lastly, the SCODI and TCODI were tested in another 25 inpatients for comparison.
Results: All of the patients in the pre-final test understood the simplified Chinese version correctly. In the final test, Cronbach’s alpha for internal consistency was 0.93. A very high intraclass correlation coefficient was observed (ICC= 0.99) in the test-retest group. The SCODI showed a significant correlation with the eight subscales of the Short Form 36, especially in physical functioning (r= 0.78, p<0.001). There was a moderate correlation between the ODI scores and the VAS (r=0.69, p<0.001). A significant difference in the mean score was demonstrated between the SCODI and the TCODI. Patients who participated in the comparison test all agreed that the SCODI was easier to understand than the TCODI.
Conclusion: The results showed that the translation and adaptation were successful. The SCODI has proven to be valid and reliable when used in the simplified Chinese speaking population.

KEY WORDS: Low back pain, Oswestry disability index, reliability, validitypatients assessmentQuitily of life

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