Inova / Charité Enteryx / Revive (KCCQ) Kansas City Cardiomyopathy Questionnaire Revive. Owestry disability index - PDF

SF36 Inova / Charité SF12 Enteryx / Revive (KCCQ) Kansas City Cardiomyopathy Questionnaire Revive EQ-5D Revive Owestry disability index Charite Charlson score Revive Euroscore Sicilian Registry / Taxus

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SF36 Inova / Charité SF12 Enteryx / Revive (KCCQ) Kansas City Cardiomyopathy Questionnaire Revive EQ-5D Revive Owestry disability index Charite Charlson score Revive Euroscore Sicilian Registry / Taxus PCI Sicilian Registry IIEF Endocare Continence Score Endocare IPSS Questionnaire Endocare UFS QOL UFE (Uterine Fibroid Symptom and Quality of Life questionnaire) Score and e-crf Score implementation in e-registry a big challenge for KIKA Introduction Nowadays more and more clinicians think that it is not possible to separate disease from individual personal and social context. In addition risk models are used in order to support surgical/medical decision As a consequence health related life quality score implementation in e-crf going to increase Score data in medical registry Score characteristic Assesment/Decision Tool Scores are designed for assesment Assesment is performed to make decision Demanding data collection The user needs immediatly the results The data collection has to be performed at once The patient becomes the person we are speaking to Expertise and data score management We need to develop an expertise in implementation of score on line To capitalize on our experience and knowledge Centralized information on the score That s why we are implementing Eventa librairy Eventa Library is being implemented in order to set up score standard SOPs for score implementation in project You are welcome to send your comments at : subject:eventa Library Risk model Purpose: this type of score going to provide predictive value based on risk factor (for Euroscore European System for Cardiac Operative Risk Evaluation a mortality predictive value is calculated in adult cardiac surgery) Method The different types of score : patients undergoing open heart surgery has been observed. Risk factors have been defined by statistic analysis method. From this cohorte observation the risk model Euroscore has been created for an European population Scientific Validation Euroscore has been validated in several country by trial comparing predictive value of Euroscore with local model or previous system Euroscore translation has been also validated taking into account the cultural difference and / or the difference of population This score is now widely use in Europe and elsewhere. It has been well validated and now is becoming a reference tool for surgical decision making. Some think Euroscore could be an international standard which can be used as a benchmark for risk assessment in inter-hospital and international studies Quality of life assesment Purpose: A state of complete physical, mental, and social wellbeing and not merely the absence of disease. It is also agreed that HRQL is multi-dimensional, subjective and, ideally selfadministrated The scale can be a generic one or aimed at a specific disease Method The height health concept the most used was selected in order to build the SF36. Those concepts have been also chosen because there the most affected by deases and treatements. A first selection of 149 items has been performed. And the SF36 form is based on this selection Scientific Validation The validity of the content of SF36 has been compared with that of other widely used generic health survey The score has to be validated in the specific disease, in the population, in the language SF36 is not aimed to measure sleep adequacy cognitive functioning, sexual functioning, health distress, family functioning, self esteem, eating, recreation and hobbies, communication, and symptoms and problems that are specific to a particular condition Score already set up in Eventa Euroscore: Item presentation Type of information collected Algorithm Missing data Management score calculation Algorithm reference Validation Eventa library Score implementation in Registry SF36 Item presentation Type of information collected Algorithm Subscale Missing data Management Total score calculation Algorithm reference Validation Eventa library Score implementation in Registry Score Management on line Design and Data Collection for e-score Form Adaptation to web tool of a validated form Guideline for the e-crf conception Standard form Scientific references Clear process for the data collection Data Entry Signature SDV Data validation Data correction Score data analysis Descriptive statistics on line type of statistics Objective of online statistics Data score validation Internal consistency Missing data Warning set up according the logistic rules Consistency with other e-crf data Consistency between the data of the score Statistics for e-score Plan the statistics on line Number of score completed by visit Means of the score by visit Means of difference between baseline and follow up visit Final statistic report Clear Statistic Plan analysis objective Programmed by SAS at the end of the study but can be put on line in PDF format Administrative Guidance Guidance EAMEA Draft for HRQL HRQL and Guidance Guidance FDA Secondary end point Link to specific deases (oncology) The phase III cannot be based only on HRQL (PRO) Patient report outcome To collect the patient feedback on the treatment Collect data from the patient Because the trials are now taking into account the patient point of view Conclusion We need: Some tools should be implemented to have the most accurate data for the score Check list to propose efficient full process since data collection to data analysis Plan statistics on line Include statistic analysis in the final statistic plan Internal rules to adapt the paper score to the web technology Standardized score the one way to improve scoring on line We need to follow regulation evolution guidance to be compliant (best will be participate to elaboration to the guidance) References for additional information Regulatory documents EMEA (European Medicines Agency) European guidance document for assessment of Health-Related Quality of life in clinical trials Refection paper on the regulatory guidance for the use of healthrelated quality of life measures in the evaluation of medicinal product Websites: Meeting comity Articles Measuring quality of life Using quality of life measure in the clinical setting ESULTFORMAT=&andorexactfulltext=and&searchid= _7333&stored_sear ch=&firstindex=0&sortspec=relevance&volume=322&firstpage=1297&resourcetype=1 The logistic EuroScore Validation of European System for Cardiac Operative Risk Evaluation (EuroScore) in North American cardiac surgery Any Question?
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