Development Of TCM Evaluation Scale For Patients With Chronic Obstructive Pulmonary Disease "Reported By Patients"

Objective:To constitute a patient reported outcome (PRO) Instruments for COPD with characters of Traditional Chinese Medicine(TCM).It may be used to estimate of curative effect of TCM for COPD patients about PRO.In this study methods and steps of constituting scale will be further perfected. Ways of quality control will so.Methods:1.In virtue of study ways of scales field in domestic and overseas,concept of PRO and its domains meaning will be determined,combining with Chinese cultural background and a COPD’s clinical traits in TCM.Items were screened out to form items pool. Asking and replying forming in the items of profile.a yardstick of their reaction and layout of the scale were established at the same time. The items of scale were disposed properly by means of experts’ comments, small-scale pretest and regular pretests. To simplify and optimize the items further, a series of statistical methods were used to all-around analyze pretested results of the instruments, so PRO Instruments for COPD with characters of TCM was formed finally.2.In this study, on the basis of following PRO methods and steps, conventional ways were decomposed and composed renewedly, a new methods or step was formed(it including four steps). Some conventional steps were fined and deepened further. Some new statistical methods, such as collinarity diagnosis, component matrix and etc, were introduced into this study.3.In the course of the scale’s study, mainly by means of quoting and proving fully, cultivating conners, spreading propaganda among the patients seriously, complying with the principle of clinical scientific research, regular and non-scheduled examining of quality controller and so on, we insured the scale study favourable and ensured its quality.Results:Setting of domains and items of instruments:At the same time of concept of PRO about COPD patients was established, we established syndromic domain of TCM,physical, mental, individual life domains(including environment) and remedial satisfaction as the domains of this instruments.Its items were simplified and optimized many time and finally they were cut down to37items. Inthem there12items in syndromic domain of TCM,5items respectively in physical,4items respectively mental,7items respectively in individual life domains,7items respectively in remedial satisfaction. There are two items as whole ones in the instruments. They constituted QOLISP together.Conclusions:1. Multidimensional ways were used to compile and constitute this instruments. It includes five domains of syndromic domain of TCM,physical, mental, individual life domains(including environment) and remedial satisfaction.It tally with accepted guide rule of constituting PRO scales and has some idiocratic content of TCM. After the items were processed many times by means of increasing, deleting, modify, merging, adjusting and spoken language ways, and a serial of statistical measures and etc, the items’ quality of the instruments was markedly raised.2. On the basis of following common methods and steps of PRO study, conventional ways were further fined,deepened and specialized. A new way of PRO Instruments for COPD with characters of TCM was formed with clearer, more concrete and easier operational steps. Some new statistical methods were introduced into this study.3. The methods of quality control are valid and feasible In this study. It insures the instruments study and its clinical probation go on wheels, so this insure quality of the instruments be good. A suit of new applied methods of quality control come into being in practice.4.Accepted, callback and accomplished rates of this instruments are very good. Its accomplished time is not long. So its clinical feasibility is good.