Stroke Spastic Hemiplegia Pro Scale Revised, And Reliability, Validity, And Responsiveness Testing,

BackgroundPatient Reported Outcomes(PRO) refers to get information reported directly from patients through interviews,self-assessment questionnaire or other data capture tools,such as the dairy of the patient's daily life,health status and treatment measures.Based on psychological theory and methods,PRO is scientific means in assessing the clinical outcome. Because PRO emphasis on patients' feeling,the application of PRO help doctors understand a patient's health status more clearly and make better clinical decisions.The information doctors collected could be used in scientific researches and play a role in improving patient's quality of life.Stroke is a disease with high disability rate.Statistics show that among the survival who suffered from stroke in the first week,73%- 86%of them have hemiplegia or monoplegia, 71%-77%have difficulties in moving and 47%can't sit by themselves,which has seriously affected the quality of life.Existing scales for stroke patients focus on patient's spasticity, quality of life and activities of daily life and put less emphasis on what patients reported.At the same time,most of the scales we used are translations from other languages,which are not suitable for Chinese patients because of the cultural background barrier.So the measuring scale based on the clinical outcome must be developed.In the former research,according to the Guidance for Industry Patient-Reported Outcome Measures:Use in Medical Product Development to Support Labeling Claims drafted by U.S.Food and Drug Administration in February 2006,we have developed the PRO scale and managed clinical test for the first.The results show that the scale has good reliability,validity and responsibility.This time,we adjusted the items of the scale and made the clinical test for the second time.Statistics obtained during the test were analyzed.ObjectiveAdjust the items and analyze the reliability,validity and responsibility of the scale.Methods1.Response options.Take the 5-point Likert Scale as the response option of Patient Reported Outcomes for apoplexy spastic-paralysis patients by literature searching and expert consulting.2.Evaluation of the item. By group discussion,literature searching and expert consulting,the evaluation of the item was changed from"1-5"to"0-4".3.Item Adjusting.According to former research,delete 3items which influenced the Cronbach's of the scale.Improve the scale with cognitive interview.Make the outline of cognitive interview,go on with the interview and make recording at the time.Adjust the items according to the interview.After adjustment,the scale contains 16 items,which are divided into 3 domains. The scale take 5-point Likert scale as its response option and the value of each item is from 0 to 4.4.Clinical test.Make investigator manual and get the investigators trained.Begin the clinical test with PRO scale and 3 other scales(Barthel,SS-QOL,Ashworth).During the test,the monitor is responsible for regular inspections of the quality the investigation in each center.Sieve the data and analyze the reliability,validity and responsibility of the scale with SPSS 11.5.5.Scale confirmation.In accordance with the result of data analysis,finally confirm the scale based on Patient Reported Outcomes for apoplexy spastic-paralysis patients.Results1.The scale based on Patient Reported Outcomes for apoplexy spastic-paralysis patients was confirmed,which included three domains(16 items).The value of the answers was changed from 1-5 to 0-4.2.Make further analysis to the patients who received investigation and it was founded that the scale had better reponsibility when it was used to patients who are less educated,stayed in BrunstromⅢand with a disease course less than 6 months.3.Data of the 109 cases was analyzed and results show that the split-half reliability coefficients were 0.820,0.883,and the Cronbach's a coefficients of the scale were all above 0.7.With the effect size as 0.35,the scale has a good responsibility.The analysis of validity indicates that the scale is of high corelation with SS-QOL and Barthel Index,and is of little corelation with modified Ashworth scale.The result also shows that the scale has better construct validity when it is divided into 3 domains.4.The scale based on Patient Reported Outcomes for apoplexy spastic-paralysis patients has better reliability and construct validity when its value of item is "0-4" than that of"1-5".Discussion1.The scale based on Patient Reported Outcomes for apoplexy spastic-paralysis patients aims to measure patients' feeling from 3 aspects of symptoms,mental state and social function.Statistics show that the scale has good reliability and responsibility,and it is of high corelation with SS-QOL and Barthel Index,and is of little corelation with modified Ashworth scale.These 4 scales put emphasis on patients' feeling,quality of life,daily ability and spasticity respectively.To patients spasticity of certain extent can help them to do things sometimes,so the results are in accordance to the practice.High corelation with SS-QOL and Barthel Index tells the scale attaches importance to patients' feeling,quality of life and daily ability.Results also show that the scale has better construct validity when it is divided into 3 domains.2.Structural Equatio Modeling(SEM) and cognitive interview were used in the research. With the change of medical model,indicators of sociology and psychology appear in medical research,which are latent variables and cannot be observed directly.Traditional linear regression analysis cannot solve this problem while SEM can.For few people learn about this method,it is seldom used in researches.We tried to test the scale's construct validity with SEM and achieved satisfactory results.3.Because of the limitation of time,the sample size is not big enough and the results of SEM are influenced accordingly.Meanwhile,item response theory(IRT) is an advanced statistical method to test the scale,but it cannot be used here also because of the sample size.In coming research sample size could be enlarged to do the statistics with the two methods above. And control group(take no treatment) could be set to compare the results of two groups of patients.ConclusionThe scale based on Patient Reported Outcomes for apoplexy spastic-paralysis patients is of good reliability,validity and responsibility.It could be used in clinical work after further adjustment.