腰腿痛患者报告结局量表的研制及应用分析
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摘要
1研究背景
腰椎退行性变是一种随年龄改变的生理过程,早在20岁之前椎间盘就已经开始退变。有很多因素可以加快腰椎老化退变的进程,从而引起一系列的症状。腰椎退行性变包括退行性腰椎间盘疾病、腰椎间盘突出、腰椎管狭窄以及退行性腰椎不稳。其中,腰椎间盘突出和腰椎管狭窄常引起腰腿痛的症状。随着社会经济的发展,我国目前已经进入老龄化社会,这使得腰椎退行性变所致腰腿痛成为骨科临床最常见的疾患之一。
关于腰腿痛的治疗,绝大多数患者,尤其是首次发病者,除非有明显的马尾神经损害症状时,采用非手术治疗的方法往往能取得较好的效果。中医学认为本病主要因为气滞血瘀、风寒湿之邪侵袭、肾亏体虚所致。依照中医理论,运用中药、按摩、针灸等中医疗法,常常使患者能够得到满意的疗效。
随着医学模式由经验医学向循证医学发展,验证各种中医疗法的确切疗效是总结实践经验,规范中医临床治疗,并进行深入研究与学术交流的最基本工作。目前中医疗法临床疗效评价以医疗评价(Clinician Based Outcome, CBO)为主,缺少对患者病情与自我功能状态的客观化定量评价。而中医辩证论治的思想在整个诊疗过程中都是围绕着患者的不适进行的,对疗效评价也是以患者不适的改善为依据,所以只从医生角度评价常常不能较全面的反映中医疗法的疗效。患者报告结局(Patient Reported Outcome, PRO)是直接来自于患者的关于自身健康状况和治疗结果的报告,是一种在没有医师或其他人影响下,所进行的患者自身对疾病或健康状况的临床结局测量。引入PRO有助于对中医临床疗效的客观评价,这也是循证医学的需要。同时,PRO也符合中医理论体系的整体观念和辩证论治的基本特点。
国内临床中常用的腰腿痛患者自评量表多引自国外文献,如Oswestry功能障碍指数问卷表(Oswestry Disability Index, ODI)、Roland-Morris功能障碍问卷表(Roland-Morris Disability Questionnaire, RDQ)等,经国内学者翻译及可靠性分析后,再运用于临床。这些量表存在一定的文化差异,有时患者有一定的理解困难,而且它们更侧重于对患者躯体症状和功能活动能力的评价,对患者心理状况评价较欠缺。而这一点又是现代整体医学模式所要求的。
目前国内尚无用于评价中医疗法治疗腰椎退行性变所致腰腿痛临床疗效的PRO量表。前期我们研制了颈肩腰腿疼痛PRO量表,这是一个针对脊柱退行性疾患的普适性量表。虽然前期量表在临床的运用中有较好的信度和效度,但它对腰椎退行性疾患引起的腰腿痛患者病情评价缺少针对性。另外,统计分析结果显示部分条目与量表得分的相关性不大,去除它们时,量表的Cronbach'a系数明显高于原量表Cronbach'a系数值。PRO量表的研制是一个循环反复的过程,这些问题都有待本研究的修正。
本研究继续按照美国食品及药物管理局(Food and Drug Administration, FDA)规定的PRO量表制作原则与流程,通过对前期量表的修订、典型病例访谈、核心小组讨论、专家咨询、借鉴国内外相关量表等方法,形成初步量表,再根据认知访谈的结果对其进行修改,随后进行量表的临床应用测试,分析量表在临床应用中的性能情况。旨在建立一个通俗易懂的、符合我国语言文化特点的、用于评价中医疗法的腰腿痛PRO量表,为中医疗法治疗腰椎退行性变所致腰腿痛提供一个客观化、标准化的疗效评价工具。
2研究目的
研制用以评价中医临床疗效的腰腿痛PRO量表,为中医疗法治疗腰椎退行性变所致腰腿痛提供一个客观化、标准化的疗效评价工具。
3研究内容与方法
按照PRO量表制作的原则与流程,通过对前期量表的修订、典型病例访谈、核心小组讨论、专家咨询、借鉴国内外相关量表等方法,形成初步量表。并对于2010年6月至2010年7月间40例腰腿痛住院患者应用本量表进行认知访谈,通过访谈结果对量表进行修改。
参照新的PRO量表的评价方法,对2010年8月至2012年1月间200例腰腿痛住院患者进行测试。从量表的可行性分析、信度、效度和反应度观察量表在临床应用中的性能情况。
4结果
4.1腰腿痛PRO量表的研制
参照PRO量表制作的原则与流程及前期颈肩腰腿疼痛PRO量表的经验,确定量表的概念框架和域,本量表仍包括躯体症状、功能活动能力、心理状况三个域。利用前期量表修订、典型病例访谈、核心小组讨论、专家咨询、借鉴国内外相关量表等方法进行条目筛选,同时确定条目的应答尺度,制作出一个由三个域十七个条目组成的腰腿痛PRO量表初稿。
利用专门制定的认知访谈手册,对患者进行访谈,逐条目进行认知测试,将被调查者提出的疑问和建议做详细记录。根据调查结果,经过专家讨论,对理解困难的条目进行语言表达上的调整,对条目和应答尺度不一致的地方进行修改,以及对应答尺度中不好区分的条目进行了完善。对条目“您的性生活受影响吗?”,考虑到其涉及病人隐私,回答较困难,通过参考文献、咨询专家,去除该条目。最终形成一个由三个域十六个条目组成的腰腿痛PRO量表。
4.2腰腿痛PRO量表在临床应用中的性能评价
4.2.1量表的可行性分析
量表的接受率和完成率均为100%,绝大多数患者(91.5%)量表完成时间为2-7分钟,完成时间较为理想,本量表完成时间明显少于ODI完成时间(P<0.01)。另外,同ODI对比可见,93.5%的患者认为腰腿痛PRO量表较ODI容易理解。这些说明所研制的腰腿痛PRO量表能够较好的被腰腿痛患者所接受和完成,在临床应用中具有较好的可行性。
4.2.2信度评价
外在信度使用重测信度评价,时间间隔选择为1-2周。首先患者自评病情没有变化,再进行第二次测量。结果显示二次所测量表得分及各域得分间无显著性差异(P>0.05),且有显著相关性(r>0.9)。这说明量表的稳定性较好。
内在信度用Cronbach'α系数和Guttman分半信度系数检验。量表及其各域的Cronbach'α系数均大于0.8,说明量表有较好的内在一致性。而量表及各域的Guttman分半信度系数均大于0.7,说明量表的跨条目的一致性较好。经过内在信度的评价表明腰腿痛PRO量表测量结果有较好的一致性。
4.2.3效度评价
内容效度评价,量表的研制过程中,每一步都经过专家的讨论,以专家的评议作为依据对量表进行修改。另外,经过统计学分析,各条目得分与量表得分相关系数r均大于0.5,每个条目得分与其所属领域得分的相关系数r也均大于0.5,而与其他领域得分的相关系数值均小于与其所属领域得分的相关系数值。由此可见,本量表能够测量本研究所需要测量的概念和领域。
校标关联效度评价中本研究选用的参照量表为ODI,本量表与ODI测量得分的相关系数r>0.8,有较好的校标关联效度。这说明本量表具有评价腰腿痛患者病情的能力。
关于结构效度评价采用目前最为常用的因子分析法进行评价。首先,对量表及各域进行KMO统计量和Bartlett球形检验分析,量表及各域的KMO统计量均大于0.7,说明它们适合做因子分析,而Bartlett球形检验中P值均小于0.01,说明它们中条目间具有相关性。通过对量表和各域提取公因子,根据选取特征值大于或等于1的因子作为公因子的原则,发现量表可以提取三个公因子,而各域均能提取一个公因子,这说明量表和各域间的公因子数一致。再运用最大方差正交旋转的方法,从结果中可看出,三个公因子分别主要与躯体症状域、功能活动能力域、心理状况域中的条目相关,这说明量表的结构与预想的三个维度基本一致,其结构清晰,具有良好的结构效度。
4.2.4反应度评价
为了缩小测量患者病情变化的程度,选择以中医疗法为主的综合保守治疗2周后的患者,且自评病情好转,病情基本治愈的患者除外。测试结果显示,效应尺度为0.67,患者治疗前后腰腿痛PRO量表评分的差异有统计学意义(P<0.01)。由此可见本量表能够较敏感的反映患者病情变化。
5结论
本研究所研制的腰腿痛PRO量表覆盖了躯体症状、功能活动能力和心理状况三个域十六个条目,比较全面地反映了量表的内涵,且语言通俗易懂、易于回答,具有较好的患者认知性。
从量表接受率、完成率和完成时间三个方面分析,以及同ODI对比,证明本量表在临床应用中具有可行性。利用对患者的测试数据进行统计学分析,结果显示本量表具有较好的信度、效度和反应度。
通过以上分析,证实所研制的腰腿痛PRO量表可作为中医疗法治疗腰椎退行性变所致腰腿痛临床疗效的评价工具。
6创新点
国内首次按照FDA规定的PRO量表制作的原则与流程研制出的适用于中医疗法治疗腰椎退行性变所致腰腿痛患者疗效评价的腰腿痛PRO量表。
1Backgrounds
Lumbar vertebral degeneration is a change of physiological process with age. The intervertebral disc degeneration has begun before the age of twenty, and there are many factors which can speed up the aging of lumbar degenerative change process and then cause a series of symptoms. Lumbar vertebral degeneration includes degenerative intervertebral disc disease, lumbar disc herniation, lumbar spinal stenosis and degenerative instability of lumbar spine. And among these diseases, lumbar disc herniation and lumbar spinal stenosis often cause low back and leg pain. With the development of social economy, our country has entered an aging society, which makes low back and leg pain caused by lumbar degeneration become one of the most common orthopedic diseases.
Application of non-surgical treatment for most patients, especially those without cauda equina syndrome, has been proved to have good results. Traditional Chinese Medicine (TCM) holds that the disease is mainly caused by qi stagnation and blood stasis, invasion of exogenous pathogenic factors such as wind, cold, dampness and kidney insufficience, etc. According to TCM theory, patients often get satisfactory curative effect by traditional Chinese medicine, massage, acupuncture, etc.
Nowadays, medicine model is transforming from experienced medicine to evidence-based medicine. Verifying all kinds of TCM therapies is the base for summarizing clinical practice experiences, standardizing the treatment of TCM and furthering research and academic communication. The evaluation of clinical curative effect of TCM therapies gives priority to Clinician Based Outcome (CBO), which lacks of objective quantitative evaluation on patients' condition and functional status. However, syndrome differentiation and treatment of TCM is always concerned with the patients'trouble on which the therapeutic evaluation is also based in the process of the diagnosis and treatment, and therefore it's hard to evalue the treatment of TCM from all sides only by the doctor's evaluation. Patient Reported Outcome (PRO) is an instrument assessing patients'health condition and treatment results, which are collected directly from patients'own evaluation without the influence of doctors and others. So the introduction of PRO is helpful for the objective assessment on clinical efficacy of TCM intervention, and also meets the need of evidence-based medicine. At the same time, PRO also accords with the basic characteristics of TCM theoretical system such as the holism and the syndrome differentiation and treatment.
Self-rating scales on lumbocrural pain often quote from foreign literature domestically, for instance, Oswestry Disability Index (ODI), Roland-Morris Disability Questionnaire (RDQ). They are applied to clinical evaluation after being translated into Chinese and analyzed their reliabilities. However, there are cultural differences in those questionnaires or indexes, which may cause misleading. On the other hand, those scales focus mainly on the evaluation of somatic symptoms and functional activities, and often ignore patients'psychological situation relatively, which is required by the modern overall medical model.
So far, there hasn't been PRO scales used in the evaluation of the treatment of TCM on lumbago and leg pain caused by lumbar degeneration domestically. We developed a PRO scale shoulder neck and lumbocrural pain early which is a generic scale for the whole spinal degenerative diseases. Although early scale in clinical use has a good reliability and validity degree, its evaluation of lumbar degenerative disease patients lacks of pertinence. Besides, statistical analysis showed that the correlation between some items and the total scale is low, and after they were removed, the value of Cronbach'a coefficient of the scale became significantly higher. Since the development of the PRO scale is a circular process, this study will revise these problems.
According to the production principle and process of PRO scales which was issued by U.S. Food and Drug Administration (FDA), the original instrument was formed by revising early scale, interviewing typical cases, focus group discussion, expert consulting, referring to domestic and foreign related instruments, etc. And then the scale was modified on the result of the cognitive interview, which was followed by clinical application in order to analyse the performance of the scale in clinical application. We aimed at developing an objective standardized assessment tool which is easily understandable, and accords with the characteristics of Chinese language and culture, and appraises clinical efficacy of TCM therapies on lumbago and leg pain caused by lumbar degeneration.
2Objective
To develop a low back and leg pain PRO scale used to evaluate the treatment of TCM on lumbocrural pain caused by lumbar degeneration objectively and standardizedly.
3Methods
According to the production principle and process of PRO scales, the original instrument was formed by revising early scale, interviewing typical cases, focus group discussion, expert consulting, referring to domestic and foreign related instruments, etc. And then40inpatients participated in the cognitive interview between June2010and July2010. Finally the scale was modified on the result of the interview.
Referring to evaluation method of new PRO scales,200inpatients were tested by the instrument from August2010to January2012. Its performances in clinical application were observed from feasibility of the scale, reliability, validity and responsibility.
4Results
4.1The development of the PRO scale for low back and leg pain
Refering to the production principle and process of PRO scales, and early experiences of the PRO scale for shoulder neck and lumbocrural pain, the conceptual framework and domains were determined. Domains including somatic symptoms, functional ability, psychological status were covered in the scale yet. Item selection was conducted by interviewing typical cases, focus group discussion, consulting experts, referring to domestic and foreign related scales. Meanwhile, response scales of item were made. The preliminary scale composed of3domains and17items was developed eventually.
The cognitive test was conducted by special developed form made to interview the patients. Items were asked one by one and the questions and advices from respondents were documented in detail. The items that were hard to understand were modified in their language expression; the inconsistency between the items and their response scales was adjusted; the response scales that were hard to differentiate were perfected; and the item "Was your sex life affected?", which involved patients' personal privacy and was difficult to answer was deleted by referring to the literature and consulting the experts. The low back and leg pain PRO scale consisting of three domains and sixteen items was developed eventually.
4.2Performance evaluation of low back and leg pain PRO scale in clinical application
4.2.1Feasibility analysis of the scale
Acceptance rate and completion rate of the instrument were100%. Most patients (91.5%) completed the scale from2minutes to7minutes, and the completion time was significantly less than ODI (P<0.01), so the completion time is sound. Furthermore,93.5%of patients considered that the low back and leg pain PRO scale was easier to understand than ODI. These display that the low back and leg pain PRO scale can be well accepted and completed by patients and has a good feasibility in clinical application.
4.2.2Reliability evaluation
Test-retest reliability was adopted to evaluate external reliability, and time interval was set from one to two weeks. The patients were required to complete the scale after they reported by themselves that their conditions didn't change. The results showed that there were no significant difference (P>0.05) and significant correlation (r>0.9) between the total scores and the scores of each domain. These shows the stability of the scale is fine.
Internal reliability was tested by Cronbach's Alpha coefficient and Guttman split-half reliability coefficient. Cronbach alpha coefficients of the scale and its each domain were greater than0.8, so it wasn't difficult to find that the instrument had good internal consistency. On the other hand, their Guttman split-half reliability coefficiens were more than0.7too, which showed that its consistency across the items was nice. Therefore, low back and leg pain PRO scale is proved to have better consistency by the evaluation of internal reliability.
4.2.3Validity evaluation
Content validity was observed from each step of development process of the scale discussed by experts and its modification based on expert reviews. Besides, the correlation coefficients between the scale and its items were greater than0.5, and the coefficients between each item and its corresponding domain were not less than0.5too, which were more than the coefficients between these items and other fields. Consequently, the concept and the domain measured by the instrument meet the requirements of this study.
ODI was chosen as a reference scale in the evaluation of criterion-related vadility. Measurement results of the instrument had significant correlation (r>0.8)with ODI, which indicated that the scale had a well criterion-related vadility. Therefore, This instrument has the ability of the assessment of the disease in patients with low back and leg pain.
Factor analysis was adopted, which is the most commonly used at present to evalue construct vadility. Firstly, the scale and its domains were tested by KMO and Bartlett's test of sphericity. The KMO values of the scale and its domains were more than0.7, which show that they were suitable for factor analysis. And all P values were less than0.01in Bartlett test, so there was correlation among the items of the instrument and its domains. According to eigenvalue greater than or equal to1chosen as a common factor, three common factors was extracted from the total scale, and each domain had one common factor. As a consequence, it can be concluded that the number of common factors between the scale and the domains is same. Finally, the results showed three common factors were mainly related with three domains of the scale respectively after varimax rotation was used, which indicated that the structure of the scale and the plan of three dimensions were basically identical. Therefore, the instrument has clear structure and good structure validity.
4.2.4Responsibility evaluation
In order to narrow degree of patients' condition changes, the choices were given priority to patients who felt better rather than essentially recovered after two weeks of conservative treatment based on TCM. The test results showed that effect size was0.67, and the scores of the low back and leg pain PRO scale before and after the treatment had stasitical significance (P<0.01). These indicate that the instrument is able to reflect changes of patients' condition sensitively.
5Conclusion
The low back and leg PRO scale covers sixteen items and three domains that include somatic symptoms, functional ability, psychological status. It can fully reflect the connotation of the scale. Its language is popular and easy to be understood and responded, which means it has good patient cognition.
The scale has a nice feasibility in clinical application as being analyzed from acceptance rate, completion rate, completion time and comparison with ODI. Statistics show the instrument has a good reliability, validity and responsibility degree.
The above analysis proves that the low back and leg PRO scale is a good instrument for evaluating the clinical curative effect of TCM therapies applied in lumbago and leg pain caused by lumbar degeneration.
6Innovations
The PRO scale is suitable for evaluating clinical efficacy of TCM therapies on low back and leg pain caused by lumbar degeneration, which has been made domestically for the first time according to production principle and process issued by FDA.
腰椎退行性变是一种随年龄改变的生理过程,早在20岁之前椎间盘就已经开始退变。有很多因素可以加快腰椎老化退变的进程,从而引起一系列的症状。腰椎退行性变包括退行性腰椎间盘疾病、腰椎间盘突出、腰椎管狭窄以及退行性腰椎不稳。其中,腰椎间盘突出和腰椎管狭窄常引起腰腿痛的症状。随着社会经济的发展,我国目前已经进入老龄化社会,这使得腰椎退行性变所致腰腿痛成为骨科临床最常见的疾患之一。
关于腰腿痛的治疗,绝大多数患者,尤其是首次发病者,除非有明显的马尾神经损害症状时,采用非手术治疗的方法往往能取得较好的效果。中医学认为本病主要因为气滞血瘀、风寒湿之邪侵袭、肾亏体虚所致。依照中医理论,运用中药、按摩、针灸等中医疗法,常常使患者能够得到满意的疗效。
随着医学模式由经验医学向循证医学发展,验证各种中医疗法的确切疗效是总结实践经验,规范中医临床治疗,并进行深入研究与学术交流的最基本工作。目前中医疗法临床疗效评价以医疗评价(Clinician Based Outcome, CBO)为主,缺少对患者病情与自我功能状态的客观化定量评价。而中医辩证论治的思想在整个诊疗过程中都是围绕着患者的不适进行的,对疗效评价也是以患者不适的改善为依据,所以只从医生角度评价常常不能较全面的反映中医疗法的疗效。患者报告结局(Patient Reported Outcome, PRO)是直接来自于患者的关于自身健康状况和治疗结果的报告,是一种在没有医师或其他人影响下,所进行的患者自身对疾病或健康状况的临床结局测量。引入PRO有助于对中医临床疗效的客观评价,这也是循证医学的需要。同时,PRO也符合中医理论体系的整体观念和辩证论治的基本特点。
国内临床中常用的腰腿痛患者自评量表多引自国外文献,如Oswestry功能障碍指数问卷表(Oswestry Disability Index, ODI)、Roland-Morris功能障碍问卷表(Roland-Morris Disability Questionnaire, RDQ)等,经国内学者翻译及可靠性分析后,再运用于临床。这些量表存在一定的文化差异,有时患者有一定的理解困难,而且它们更侧重于对患者躯体症状和功能活动能力的评价,对患者心理状况评价较欠缺。而这一点又是现代整体医学模式所要求的。
目前国内尚无用于评价中医疗法治疗腰椎退行性变所致腰腿痛临床疗效的PRO量表。前期我们研制了颈肩腰腿疼痛PRO量表,这是一个针对脊柱退行性疾患的普适性量表。虽然前期量表在临床的运用中有较好的信度和效度,但它对腰椎退行性疾患引起的腰腿痛患者病情评价缺少针对性。另外,统计分析结果显示部分条目与量表得分的相关性不大,去除它们时,量表的Cronbach'a系数明显高于原量表Cronbach'a系数值。PRO量表的研制是一个循环反复的过程,这些问题都有待本研究的修正。
本研究继续按照美国食品及药物管理局(Food and Drug Administration, FDA)规定的PRO量表制作原则与流程,通过对前期量表的修订、典型病例访谈、核心小组讨论、专家咨询、借鉴国内外相关量表等方法,形成初步量表,再根据认知访谈的结果对其进行修改,随后进行量表的临床应用测试,分析量表在临床应用中的性能情况。旨在建立一个通俗易懂的、符合我国语言文化特点的、用于评价中医疗法的腰腿痛PRO量表,为中医疗法治疗腰椎退行性变所致腰腿痛提供一个客观化、标准化的疗效评价工具。
2研究目的
研制用以评价中医临床疗效的腰腿痛PRO量表,为中医疗法治疗腰椎退行性变所致腰腿痛提供一个客观化、标准化的疗效评价工具。
3研究内容与方法
按照PRO量表制作的原则与流程,通过对前期量表的修订、典型病例访谈、核心小组讨论、专家咨询、借鉴国内外相关量表等方法,形成初步量表。并对于2010年6月至2010年7月间40例腰腿痛住院患者应用本量表进行认知访谈,通过访谈结果对量表进行修改。
参照新的PRO量表的评价方法,对2010年8月至2012年1月间200例腰腿痛住院患者进行测试。从量表的可行性分析、信度、效度和反应度观察量表在临床应用中的性能情况。
4结果
4.1腰腿痛PRO量表的研制
参照PRO量表制作的原则与流程及前期颈肩腰腿疼痛PRO量表的经验,确定量表的概念框架和域,本量表仍包括躯体症状、功能活动能力、心理状况三个域。利用前期量表修订、典型病例访谈、核心小组讨论、专家咨询、借鉴国内外相关量表等方法进行条目筛选,同时确定条目的应答尺度,制作出一个由三个域十七个条目组成的腰腿痛PRO量表初稿。
利用专门制定的认知访谈手册,对患者进行访谈,逐条目进行认知测试,将被调查者提出的疑问和建议做详细记录。根据调查结果,经过专家讨论,对理解困难的条目进行语言表达上的调整,对条目和应答尺度不一致的地方进行修改,以及对应答尺度中不好区分的条目进行了完善。对条目“您的性生活受影响吗?”,考虑到其涉及病人隐私,回答较困难,通过参考文献、咨询专家,去除该条目。最终形成一个由三个域十六个条目组成的腰腿痛PRO量表。
4.2腰腿痛PRO量表在临床应用中的性能评价
4.2.1量表的可行性分析
量表的接受率和完成率均为100%,绝大多数患者(91.5%)量表完成时间为2-7分钟,完成时间较为理想,本量表完成时间明显少于ODI完成时间(P<0.01)。另外,同ODI对比可见,93.5%的患者认为腰腿痛PRO量表较ODI容易理解。这些说明所研制的腰腿痛PRO量表能够较好的被腰腿痛患者所接受和完成,在临床应用中具有较好的可行性。
4.2.2信度评价
外在信度使用重测信度评价,时间间隔选择为1-2周。首先患者自评病情没有变化,再进行第二次测量。结果显示二次所测量表得分及各域得分间无显著性差异(P>0.05),且有显著相关性(r>0.9)。这说明量表的稳定性较好。
内在信度用Cronbach'α系数和Guttman分半信度系数检验。量表及其各域的Cronbach'α系数均大于0.8,说明量表有较好的内在一致性。而量表及各域的Guttman分半信度系数均大于0.7,说明量表的跨条目的一致性较好。经过内在信度的评价表明腰腿痛PRO量表测量结果有较好的一致性。
4.2.3效度评价
内容效度评价,量表的研制过程中,每一步都经过专家的讨论,以专家的评议作为依据对量表进行修改。另外,经过统计学分析,各条目得分与量表得分相关系数r均大于0.5,每个条目得分与其所属领域得分的相关系数r也均大于0.5,而与其他领域得分的相关系数值均小于与其所属领域得分的相关系数值。由此可见,本量表能够测量本研究所需要测量的概念和领域。
校标关联效度评价中本研究选用的参照量表为ODI,本量表与ODI测量得分的相关系数r>0.8,有较好的校标关联效度。这说明本量表具有评价腰腿痛患者病情的能力。
关于结构效度评价采用目前最为常用的因子分析法进行评价。首先,对量表及各域进行KMO统计量和Bartlett球形检验分析,量表及各域的KMO统计量均大于0.7,说明它们适合做因子分析,而Bartlett球形检验中P值均小于0.01,说明它们中条目间具有相关性。通过对量表和各域提取公因子,根据选取特征值大于或等于1的因子作为公因子的原则,发现量表可以提取三个公因子,而各域均能提取一个公因子,这说明量表和各域间的公因子数一致。再运用最大方差正交旋转的方法,从结果中可看出,三个公因子分别主要与躯体症状域、功能活动能力域、心理状况域中的条目相关,这说明量表的结构与预想的三个维度基本一致,其结构清晰,具有良好的结构效度。
4.2.4反应度评价
为了缩小测量患者病情变化的程度,选择以中医疗法为主的综合保守治疗2周后的患者,且自评病情好转,病情基本治愈的患者除外。测试结果显示,效应尺度为0.67,患者治疗前后腰腿痛PRO量表评分的差异有统计学意义(P<0.01)。由此可见本量表能够较敏感的反映患者病情变化。
5结论
本研究所研制的腰腿痛PRO量表覆盖了躯体症状、功能活动能力和心理状况三个域十六个条目,比较全面地反映了量表的内涵,且语言通俗易懂、易于回答,具有较好的患者认知性。
从量表接受率、完成率和完成时间三个方面分析,以及同ODI对比,证明本量表在临床应用中具有可行性。利用对患者的测试数据进行统计学分析,结果显示本量表具有较好的信度、效度和反应度。
通过以上分析,证实所研制的腰腿痛PRO量表可作为中医疗法治疗腰椎退行性变所致腰腿痛临床疗效的评价工具。
6创新点
国内首次按照FDA规定的PRO量表制作的原则与流程研制出的适用于中医疗法治疗腰椎退行性变所致腰腿痛患者疗效评价的腰腿痛PRO量表。
1Backgrounds
Lumbar vertebral degeneration is a change of physiological process with age. The intervertebral disc degeneration has begun before the age of twenty, and there are many factors which can speed up the aging of lumbar degenerative change process and then cause a series of symptoms. Lumbar vertebral degeneration includes degenerative intervertebral disc disease, lumbar disc herniation, lumbar spinal stenosis and degenerative instability of lumbar spine. And among these diseases, lumbar disc herniation and lumbar spinal stenosis often cause low back and leg pain. With the development of social economy, our country has entered an aging society, which makes low back and leg pain caused by lumbar degeneration become one of the most common orthopedic diseases.
Application of non-surgical treatment for most patients, especially those without cauda equina syndrome, has been proved to have good results. Traditional Chinese Medicine (TCM) holds that the disease is mainly caused by qi stagnation and blood stasis, invasion of exogenous pathogenic factors such as wind, cold, dampness and kidney insufficience, etc. According to TCM theory, patients often get satisfactory curative effect by traditional Chinese medicine, massage, acupuncture, etc.
Nowadays, medicine model is transforming from experienced medicine to evidence-based medicine. Verifying all kinds of TCM therapies is the base for summarizing clinical practice experiences, standardizing the treatment of TCM and furthering research and academic communication. The evaluation of clinical curative effect of TCM therapies gives priority to Clinician Based Outcome (CBO), which lacks of objective quantitative evaluation on patients' condition and functional status. However, syndrome differentiation and treatment of TCM is always concerned with the patients'trouble on which the therapeutic evaluation is also based in the process of the diagnosis and treatment, and therefore it's hard to evalue the treatment of TCM from all sides only by the doctor's evaluation. Patient Reported Outcome (PRO) is an instrument assessing patients'health condition and treatment results, which are collected directly from patients'own evaluation without the influence of doctors and others. So the introduction of PRO is helpful for the objective assessment on clinical efficacy of TCM intervention, and also meets the need of evidence-based medicine. At the same time, PRO also accords with the basic characteristics of TCM theoretical system such as the holism and the syndrome differentiation and treatment.
Self-rating scales on lumbocrural pain often quote from foreign literature domestically, for instance, Oswestry Disability Index (ODI), Roland-Morris Disability Questionnaire (RDQ). They are applied to clinical evaluation after being translated into Chinese and analyzed their reliabilities. However, there are cultural differences in those questionnaires or indexes, which may cause misleading. On the other hand, those scales focus mainly on the evaluation of somatic symptoms and functional activities, and often ignore patients'psychological situation relatively, which is required by the modern overall medical model.
So far, there hasn't been PRO scales used in the evaluation of the treatment of TCM on lumbago and leg pain caused by lumbar degeneration domestically. We developed a PRO scale shoulder neck and lumbocrural pain early which is a generic scale for the whole spinal degenerative diseases. Although early scale in clinical use has a good reliability and validity degree, its evaluation of lumbar degenerative disease patients lacks of pertinence. Besides, statistical analysis showed that the correlation between some items and the total scale is low, and after they were removed, the value of Cronbach'a coefficient of the scale became significantly higher. Since the development of the PRO scale is a circular process, this study will revise these problems.
According to the production principle and process of PRO scales which was issued by U.S. Food and Drug Administration (FDA), the original instrument was formed by revising early scale, interviewing typical cases, focus group discussion, expert consulting, referring to domestic and foreign related instruments, etc. And then the scale was modified on the result of the cognitive interview, which was followed by clinical application in order to analyse the performance of the scale in clinical application. We aimed at developing an objective standardized assessment tool which is easily understandable, and accords with the characteristics of Chinese language and culture, and appraises clinical efficacy of TCM therapies on lumbago and leg pain caused by lumbar degeneration.
2Objective
To develop a low back and leg pain PRO scale used to evaluate the treatment of TCM on lumbocrural pain caused by lumbar degeneration objectively and standardizedly.
3Methods
According to the production principle and process of PRO scales, the original instrument was formed by revising early scale, interviewing typical cases, focus group discussion, expert consulting, referring to domestic and foreign related instruments, etc. And then40inpatients participated in the cognitive interview between June2010and July2010. Finally the scale was modified on the result of the interview.
Referring to evaluation method of new PRO scales,200inpatients were tested by the instrument from August2010to January2012. Its performances in clinical application were observed from feasibility of the scale, reliability, validity and responsibility.
4Results
4.1The development of the PRO scale for low back and leg pain
Refering to the production principle and process of PRO scales, and early experiences of the PRO scale for shoulder neck and lumbocrural pain, the conceptual framework and domains were determined. Domains including somatic symptoms, functional ability, psychological status were covered in the scale yet. Item selection was conducted by interviewing typical cases, focus group discussion, consulting experts, referring to domestic and foreign related scales. Meanwhile, response scales of item were made. The preliminary scale composed of3domains and17items was developed eventually.
The cognitive test was conducted by special developed form made to interview the patients. Items were asked one by one and the questions and advices from respondents were documented in detail. The items that were hard to understand were modified in their language expression; the inconsistency between the items and their response scales was adjusted; the response scales that were hard to differentiate were perfected; and the item "Was your sex life affected?", which involved patients' personal privacy and was difficult to answer was deleted by referring to the literature and consulting the experts. The low back and leg pain PRO scale consisting of three domains and sixteen items was developed eventually.
4.2Performance evaluation of low back and leg pain PRO scale in clinical application
4.2.1Feasibility analysis of the scale
Acceptance rate and completion rate of the instrument were100%. Most patients (91.5%) completed the scale from2minutes to7minutes, and the completion time was significantly less than ODI (P<0.01), so the completion time is sound. Furthermore,93.5%of patients considered that the low back and leg pain PRO scale was easier to understand than ODI. These display that the low back and leg pain PRO scale can be well accepted and completed by patients and has a good feasibility in clinical application.
4.2.2Reliability evaluation
Test-retest reliability was adopted to evaluate external reliability, and time interval was set from one to two weeks. The patients were required to complete the scale after they reported by themselves that their conditions didn't change. The results showed that there were no significant difference (P>0.05) and significant correlation (r>0.9) between the total scores and the scores of each domain. These shows the stability of the scale is fine.
Internal reliability was tested by Cronbach's Alpha coefficient and Guttman split-half reliability coefficient. Cronbach alpha coefficients of the scale and its each domain were greater than0.8, so it wasn't difficult to find that the instrument had good internal consistency. On the other hand, their Guttman split-half reliability coefficiens were more than0.7too, which showed that its consistency across the items was nice. Therefore, low back and leg pain PRO scale is proved to have better consistency by the evaluation of internal reliability.
4.2.3Validity evaluation
Content validity was observed from each step of development process of the scale discussed by experts and its modification based on expert reviews. Besides, the correlation coefficients between the scale and its items were greater than0.5, and the coefficients between each item and its corresponding domain were not less than0.5too, which were more than the coefficients between these items and other fields. Consequently, the concept and the domain measured by the instrument meet the requirements of this study.
ODI was chosen as a reference scale in the evaluation of criterion-related vadility. Measurement results of the instrument had significant correlation (r>0.8)with ODI, which indicated that the scale had a well criterion-related vadility. Therefore, This instrument has the ability of the assessment of the disease in patients with low back and leg pain.
Factor analysis was adopted, which is the most commonly used at present to evalue construct vadility. Firstly, the scale and its domains were tested by KMO and Bartlett's test of sphericity. The KMO values of the scale and its domains were more than0.7, which show that they were suitable for factor analysis. And all P values were less than0.01in Bartlett test, so there was correlation among the items of the instrument and its domains. According to eigenvalue greater than or equal to1chosen as a common factor, three common factors was extracted from the total scale, and each domain had one common factor. As a consequence, it can be concluded that the number of common factors between the scale and the domains is same. Finally, the results showed three common factors were mainly related with three domains of the scale respectively after varimax rotation was used, which indicated that the structure of the scale and the plan of three dimensions were basically identical. Therefore, the instrument has clear structure and good structure validity.
4.2.4Responsibility evaluation
In order to narrow degree of patients' condition changes, the choices were given priority to patients who felt better rather than essentially recovered after two weeks of conservative treatment based on TCM. The test results showed that effect size was0.67, and the scores of the low back and leg pain PRO scale before and after the treatment had stasitical significance (P<0.01). These indicate that the instrument is able to reflect changes of patients' condition sensitively.
5Conclusion
The low back and leg PRO scale covers sixteen items and three domains that include somatic symptoms, functional ability, psychological status. It can fully reflect the connotation of the scale. Its language is popular and easy to be understood and responded, which means it has good patient cognition.
The scale has a nice feasibility in clinical application as being analyzed from acceptance rate, completion rate, completion time and comparison with ODI. Statistics show the instrument has a good reliability, validity and responsibility degree.
The above analysis proves that the low back and leg PRO scale is a good instrument for evaluating the clinical curative effect of TCM therapies applied in lumbago and leg pain caused by lumbar degeneration.
6Innovations
The PRO scale is suitable for evaluating clinical efficacy of TCM therapies on low back and leg pain caused by lumbar degeneration, which has been made domestically for the first time according to production principle and process issued by FDA.
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