| 1BackgroundsLumbar 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.2ObjectiveTo 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.3MethodsAccording 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.4Results4.1The development of the PRO scale for low back and leg painRefering 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 application4.2.1Feasibility analysis of the scaleAcceptance 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 evaluationTest-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 evaluationContent 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 evaluationIn 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.5ConclusionThe 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.6InnovationsThe 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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