"based On The Preparation Of The Clinical Outcome Of Stroke Spastic Paralysis Patients Report Rating Scale Preliminary Inspection

BackgroundPeople think much of the function of Clinician-Reported outcomes,Physiological outcomes and Caregiver-Reported outcomes in Patient Outcomes Assessment Sources in the past. But with the change of medicine pattern, the importance of Patient Reported Outcomes (PRO) is waken up to people gradually. The results from Physiological outcomes and Caregiver-Reported outcomes are probably not consistent with patients' function and sensation. Therefore, how to measure PRO is an unavoidable problem for evaluating clinical treatment efficacy at the present time.Scale is used to assess the items of PRO which is accepted by international medical experts and it is applicable extensively. PRO instruments provide patients' information for doctors which is not found by chemical and physical methods. The development and assessment about PRO instruments are accounted in 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. It is an important problem for us to develop Chinese characteristic PRO instruments and set up Computer Assistant Testing (CAT) following PRO research abroad.Most of apoplexy patients have suffered limb spastic-paralysis for a long time, which impacts their activity and emotion seriously. However, the instruments of evaluating apoplexy spastic-paralysis used come from abroad mostly. These instruments are not special for apoplexy spastic-paralysis patients, and that there is a lack of patients' experience. Therefore, it is urgent to develop a PRO instrument specially for apoplexy spastic-paralysis patients.ObjectiveTo develop and assess the "self-evaluating instrument based on Patient Reported Outcomes for apoplexy spastic-paralysis patients".ThinkingAccording to the research target of PRO, researchers defined the concepts what to measure and operationalized the conception of apoplexy spastic-paralysis patients' reported outcomes. The indexes to be measured for the scale came into being. Then we optimized the indexes and developed the instrument's conceptual framework. After amending the questions again and again, we confirmed the item pool. With the heading and the direction accomplished, the research group developed the draft of the scale. Patients received investigation. With data collection, we analyzed the appropriate patients for the instrument and assessed the measurement. At last, researchers confirmed the "self-evaluating instrument based on Patient Reported Outcomes for apoplexy spastic-paralysis patients".Methods1. Development of the Conceptual Framework Employing the social research method and referring to the technology of scale, we had cofirmed the symptom indexes. Based on the foregoing research, according to the research target of PRO, instrument developers operationalized the conception of apoplexy spastic-paralysis patients' reported outcomes and added the indexes about psychology and sociology based on patient interviews along with reviews of the literature and expert opinion. Based on the indexes to be measured, the items were raised. Compiling the questions and options and making patients fill in the questionnaire. Patients evaluated the catholicity and representative of each item and the experts of neurology and psychology evaluated whether the item was useful to interpret the domains of the general concept. Referring to the opinions of the patients and experts, we optimized the indexes, choosed the concepts and domains to be measured and developed the conceptual framework.2. Formation of the Item Pool After redacting the questions and answers, we examined the procedures used with patients to determine readability and understanding of the items included in PRO instrument. Also, some neurology and psychology experts approved content and expression of each item. The instrument was amended time and again until patients understood and accepted it entirely. Finally, all items formed the item pool.3. Design the draft of PRO instrument Analysing response options, with the heading and the direction accomplished, our research group designed the draft of "self-evaluating instrument based on Patient Reported Outcomes for apoplexy spastic-paralysis patients".4. Test of the draft The research group developed the instrument instructions and training given to the interviewer or persons supervising PRO data collection. The patients with apoplexy spastic-paralysis were enrolled in the clinical trial. Collecting and clearing up the data, the research group analyzed the patients who were suitable for the scale. Our research group used the SPSS 11.5 software to analyse the reliability, validity and responsibility with the authentic data.5. Confirmation of the instrument With the test outcomes, we confirmed the "self-evaluating instrument based on Patient Reported Outcomes for apoplexy spastic-paralysis patients", founded the basic of PRO instrument practice.Results1. We developed the "self-evaluating instrument based on Patient Reported Outcomes for apoplexy spastic-paralysis patients". The domains of the scale includes symptom,feelings and sociality. The symptom domain has two parts with subjective symptom and objective symptom. The subjective part has five symptoms, such as pain,numbness,freeze,heaviness,tiredness. The objective part has four symptoms, such as tremble,tumefaction,clonus,sweatiness. There are six items about feelings, including cry,impatience,irascibility,depression,confidence,worry. The following items, for instance, activity,interest,relationship and economy, adhere to sociality domain.2.We analyzed the patients who received investigation. The instrument does not aim atthe patients who were relaxant paralysis. Alogia and Dementia impacted the apoplexyspastic-paralysis patients who fill in the instrument. The patients filled in the instrumentcorrectly were without alogia or midding and serious dementia. The researchers identified theintended population: According to the Diagnoses Criterion about Cerebrovascular disease, itis approved to cerebral infarction or cerebral hemorrhage by CT or MRI and the patientssuffer hemiplegia,part paralysis or quadriplegia. Furthuremore, the patients who meet thefollowing conditions, such as without examination, viscera impairment and psychopathy. Thepatients must be apprehensive and have good memory to some certain and can expressthemselves correctly. The limb with broken of the patients is freezing. Finally, the patients arewilling to attend the research.3.We examined the reliability, validity and responsibility of the scale with the authenticdata, 106 cases. The statistical results show that the split-half reliability coefficients were0.9047,0.9396; and the Cronbach's a coefficients were 0.8741,0.9003 respectively for thetotal scale. The results suggested that the scale has perfect internal consistency. We exploredthe structure by Factor Analysis, and validated it by Clustering Analysis.As a result, theoutcome was consistent with the forecast of three domains. The analysis of validity indicatedthat the validity is accord with the standard. The recall period is two weeks, and the result ofresponsibility showed the scale could reflect the change of patients' health state, viz. theresponsibility is good. Thus, we tested the PRO instrument.Disscussion1. Referring methods of social research and the knowledge of developing scale, researchers assured the scientific development of the scale; getting the items by clinical visit and exploring the intra-structure by statistics, researchers made the scale comprehensive and rational; controlling the operation regularly and optimizing the data carefully, researchers insured the data is true; the result of assessing the instrument is good, which founded the basic of its practice. 2. Principle of humanity is our foundation. Thinking much of patients' subjective experience and making the public more fully involved and empowered in the research process are primary characteristic. We quantized the clinical symptoms,feelings and society and transformed them to measurable objective indexes. We developed and tested the "self-evaluating instrument based on Patient Reported Outcomes for apoplexy spastic-paralysis patients". The locale investigation suggested the instrument may show the change of the patients' health state. Therefore, it is possible to assess the therapy effect of apoplexy spastic-paralysis with a PRO instrument. The research will provide reference for exploring the methodology of chronic diseases' evaluating system.3. It is important for TCM to people-oriented treatment. Inquiring of TCM is a main method to acquiring clinical information and treatment guidance. There are intrinsic correlation between PRO and clinical evaluation of TCM. It is meaningful for developing traditional treatment of TCM by PRO instrument to evalue clinical outcomes.4. There were some shortcomings in this research. We did not analyse weight and evaluation of each item. The instrument is short of patients' satisfaction domain. Researchers should make up the above shortcomings of the scale. After confirming the formal instrument, we should develop the countrywide model. We will facilitate Computer Assistant Testing (CAT) to apply to clinical evaluation of apoplexy spastic-paralysis.