An initiative of the International Rare Diseases Research Consortium-IRDiRC Spanish Rare Diseases Registries Research Network - SpainRDR https://spainrdr.isciii.es.

Slides:



Advertisements
Similar presentations
ENTITIES FOR A UN SYSTEM EVALUATION FRAMEWORK 17th MEETING OF SENIOR FELLOWSHIP OFFICERS OF THE UNITED NATIONS SYSTEM AND HOST COUNTRY AGENCIES BY DAVIDE.
Advertisements

Module N° 4 – ICAO SSP framework
Supporting National e-Health Roadmaps WHO-ITU-WB joint effort WSIS C7 e-Health Facilitation Meeting 13 th May 2010 Hani Eskandar ICT Applications, ITU.
Protocol Development.
USG INFORMATION SECURITY PROGRAM AUDIT: ACHIEVING SUCCESSFUL AUDIT OUTCOMES Cara King Senior IT Auditor, OIAC.
Brian A. Harris-Kojetin, Ph.D. Statistical and Science Policy
Quality Improvement/ Quality Assurance Amelia Broussard, PhD, RN, MPH Christopher Gibbs, JD, MPH.
Enhancing Data Quality of Distributive Trade Statistics Workshop for African countries on the Implementation of International Recommendations for Distributive.
Laboratory Personnel Dr/Ehsan Moahmen Rizk.
Quality evaluation and improvement for Internal Audit
Purpose of the Standards
Management of Communication and Information Chapter -MCI
Standards and Guidelines for Quality Assurance in the European
4. Quality Management System (QMS)
Chapter 7 Database Auditing Models
Internal Auditing and Outsourcing
The use and convergence of quality assurance frameworks for international and supranational organisations compiling statistics The European Conference.
Information Security Compliance System Owner Training Richard Gadsden Information Security Office Office of the CIO – Information Services Sharon Knowles.
Community Feedback and Involvement in [Health Department’s] Proposed Data to Care Program [Name of Provider Session Date of Provider Session]
Health promotion and health education programs. Assumptions of Health Promotion Relationship between Health education& Promotion Definition of Program.
Basics of OHSAS Occupational Health & Safety Management System
Elements of Clinical Trial Quality Assurance Regulatory Coordinator –SCTR SUCCESS Center QA Monitor – NIDA Clinical Trials Network Stephanie Gentilin,
Slide 1 D2.TCS.CL5.04. Subject Elements This unit comprises five Elements: 1.Define the need for tourism product research 2.Develop the research to be.
RAISING THE BAR Meeting CSA Guidelines And Preparing for Health Canada
Quality assurance activities at EUROSTAT CCSA Conference Helsinki, 6-7 May 2010 Martina Hahn, Eurostat.
Future Use of Stored Samples & Data and the NIH Policy on GWAS and dbGaP NIAID/DAIDS Dione Washington, M.S. -- ProPEP Sudha Srinivasan, Ph.D.-- TRP Tanisha.
Module N° 8 – SSP implementation plan. SSP – A structured approach Module 2 Basic safety management concepts Module 2 Basic safety management concepts.
Encounter Data Validation: Review and Project Update August 25, 2015 Presenters: Amy Kearney, BA Director, Research and Analysis Team Thomas Miller, MA.
Paris Project Meeting January 2012 Item – Statistics Objective 5 B. Proia With financial support from Criminal Justice Programme 2008 European Commission.
Product Development Chapter 6. Definitions needed: Verification: The process of evaluating compliance to regulations, standards, or specifications.
Certification and Accreditation CS Phase-1: Definition Atif Sultanuddin Raja Chawat Raja Chawat.
How to Get Started with JCI Accreditation. 2 The Accreditation Journey: General Suggestions The importance of leadership commitment: Board, CEO, and clinical.
Database Security and Auditing: Protecting Data Integrity and Accessibility Chapter 7 Database Auditing Models.
Assessing The Development Needs of the Statistical System NSDS Workshop, Trinidad and Tobago, July 27-29, 2009 Presented by Barbados.
April_2010 Partnering initiatives at country level Proposed partnering process to build a national stop tuberculosis (TB) partnership.
Programme Performance Criteria. Regulatory Authority Objectives To identify criteria against which the status of each element of the regulatory programme.
1 Status of PSC recommendations (January December 2007) Portfolio Committee on Public Service and Administration 14 March 2008.
CHAPTER V Health Information. Updates on new legislation (1)  Decision No.1605/2010/QĐ-TTg approving the National Program for Application of information.
Shaping a Health Statistics Vision for the 21 st Century 2002 NCHS Data Users Conference 16 July 2002 Daniel J. Friedman, PhD Massachusetts Department.
Riga’s AC Baseline Review Säästva Eesti Institute Heidi Tuhkanen, SEI-Tallinn Centre
1 The Future Role of the Food and Veterinary Office M.C. Gaynor, Director, FVO EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate.
Consultant Advance Research Team. Outline UNDERSTANDING M&E DATA NEEDS PEOPLE, PARTNERSHIP AND PLANNING 1.Organizational structures with HIV M&E functions.
International Security Management Standards. BS ISO/IEC 17799:2005 BS ISO/IEC 27001:2005 First edition – ISO/IEC 17799:2000 Second edition ISO/IEC 17799:2005.
2015 Pipeline Safety Trust Conference November 20 th, 2015 | New Orleans, LA API RP 1175 Pipeline Leak Detection Program Management – New RP Highlights.
United Nations Oslo City Group on Energy Statistics OG7, Helsinki, Finland October 2012 ESCM Chapter 8: Data Quality and Meta Data 1.
Project Management Project Integration Management Minder Chen, Ph.D. CSU Channel Islands
SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC.
It was found in 1946 in Geneva, Switzerland. its main purpose is to promote the development of international standards to facilitate the exchange of goods.
Copyright 2010, The World Bank Group. All Rights Reserved. Recommended Tabulations and Dissemination Section B.
An initiative of the International Rare Diseases Research Consortium-IRDiRC Spanish Rare Diseases Registries Research Network - SpainRDR
An initiative of the International Rare Diseases Research Consortium-IRDiRC Spanish Rare Diseases Registries Research Network - SpainRDR
An initiative of the International Rare Diseases Research Consortium-IRDiRC Spanish Rare Diseases Registries Research Network – SpainRDR. Inventory of.
 Principles;  Moral;  Beliefs;  Moral values; and  “A set of principles of right conduct”
An initiative of the International Rare Diseases Research Consortium-IRDiRC Spanish Rare Diseases Registries Research Network - SpainRDR
Session 2: Developing a Comprehensive M&E Work Plan.
Alex Ezrakhovich Process Approach for an Integrated Management System Change driven.
Training for organisations participating in Peer Review of Paediatric Diabetes.
Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Program Performance Criteria.
Data Coordinating Center University of Washington Department of Biostatistics Elizabeth Brown, ScD Siiri Bennett, MD.
MEASURE Evaluation Data Quality Assurance Workshop Session 3 Introduction to Routine Data Quality Assessment.
GCP (GOOD CLINICAL PRACTISE)
Steps in development of action plans ITC-ILO/ACTRAV Course A3 – Trade Union Training on Information Management for Trade Union Organization, Research.
1 CASE Computer Aided Software Engineering. 2 What is CASE ? A good workshop for any craftsperson has three primary characteristics 1.A collection of.
The role of the ECCP (1) The involvement of all relevant stakeholders – public authorities, economic and social partners and civil society bodies – at.
Albania 2021 Population and Housing Census - Plans
How to conduct Effective Stage-1 Audit
Data collection and validation support for the management of the ESF
STEPS Site Report.
Module 1.1 Overview of Master Facility Lists in Nigeria
Presentation transcript:

An initiative of the International Rare Diseases Research Consortium-IRDiRC Spanish Rare Diseases Registries Research Network - SpainRDR Josep Jiménez Servei Català de la Salut Madrid, March 2013 Quality assessment and WP4. Quality assessment and ethical and legal issues

WP4. Aims SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC It will also develop a framework to ensure data protection and compliance with ethical issues, as well as patient participation in all network activities. This WP seeks to optimise the quality of population health registries for rare diseases in Spain, by ensuring that participatory regions and centres follow pre-established procedures aimed at increasing homogeneity and minimising inaccuracy and incompleteness of data.

WP4. Tasks T17 Analysing the legal framework of health registries and translating this to RD registries T18 Establishing the approriateness of and degree of agreement between ethical principles and pthe issues raised by the development of the National RD Registry, under the overall supervision of the IIER Ethics ommittee, taking its ethical guidelines for RD registry reporting as reference SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC T15 Developing SOPs for data collection and validation T16 Defining a quality assessment framework to improve data accuracy and completeness. A set of indicators to assess quality of registries will be drawn up in accordance with the EPIRARE quality indicator project

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC T15 Developing SOPs for data collection and validation

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC Developing SOPs for data collection and validation T15. Developing SOPs for data collection and validation Topics involved in a whole RD registry process Background and fundamental bases General and specific aims Geographical and long-term settings Target and study populations Design Case-definition Case inclusion and exclusion criteria Sources of cases List of covariables Data model and data dictionary Identification of disease codes and covariables codification Statistical analysis plan Operating manual (including SOPs and report forms) Training Pilot testing Data collection Data storing, access and safety Data delivery Quality control procedures Reporting Governance Patient involvement Long-term funding Ethical and legal issues External assessment Building consensus and synergies for the registration of rare diseases patients in Europe: the EPIRARE project. Leadership by Domenica Taruscio, CNMR, ISS

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC Developing SOPs for data collection and validation T15. Developing SOPs for data collection and validation The operating manual should contain a set of standardized procedures that should describe all type of activities regarding data collection, cleaning, storage, management, analyses and reporting. Difficulties and troubles have to be prevented, and alternate options should be included in each procedure. Each Autonomous Community (AC) should develop a set of SOPs adapted to its context, but common elements need to be defined to ensure homogeneity The SOPs should be reviewed and updated periodically The quality assurance process is based on the SOPs

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC Developing SOPs for data collection and validation T15. Developing SOPs for data collection and validation 1. Policy and procedure maintenanceSchedule for reviewing and updating, responsibilities, communication of changes,… 2. General documentationGeneral registry information, project report, key contacts, agreements (partners, patient registries,…), advisory boards, committees, legislation, … 3. Catalogues and classificationsRD list and codifications, data sources, common data elements, variable dictionary,… 4. Registry operating system and data management Hardware, software, data security,… 5. Data processing operationsReporting requirements, case ascertainment, case completeness, data entry, resolution of conflicting information, death clearance, consolidation of data, processing management reports,… 6. Ethic rulesConfidenciality, informed consent,… 7. Quality controlQuality assessment plan Operating manual

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC SpainRDR Network Flowchart AC RD Registry (RD Aplication)) External Reporting Sources (Patient Registries, Health Registries, etc) Integrated data environment Consolidated data environment AC RD Registry AC File SpainRDR File AC Procedures: A.Analysis of each data source B.Integration of sources and data management C.Consolidation of the AC database D.Generation of the exchange file G. Correction of errors and updating the AC registry CC Procedures: E. Analysis of each AC exchange file F. Generation of the response file Data analysis environment (source) I SpainRDR IIER A A B C D E F G Autonomous Community (AC) SpainRDR Coordination Center

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC Developing SOPs for data collection and validation T15. Developing SOPs for data collection and validation AC SOPs Data entry: Data structure User’s manual Procedures manual Data sources: Source analysis Data integration and management procedures Consolidation of the database Security document CC SOPs Importation of AC files Generation of AC errors and queries file External data sources Data process and management Security document Correction of errors and queries response AC registry updating Generation of the AC exchange file

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC Developing SOPs for data collection and validation T15. Developing SOPs for data collection and validation AC SOPs Data entry: Data structure User’s manual Procedures manual Data sources: Source analysis Data integration and management procedures Consolidation of the database Security document CC SOPs Importation of AC files Generation of AC errors and queries file External data sources Data process and management Security document Correction of errors and queries response AC registry updating Generation of the AC exchange file AC diversity: -Health care models -Information systems COMPLEXITY HETEROGENEITY RD list Multiplicity of sources: -Interoperability -Pacient identification -RD codification -Values conflicts -Access to the data source Common elements are needed to ensure homogeneity

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC Developing SOPs for data collection and validation T15. Developing SOPs for data collection and validation SOP structure Cover: SOP Ref No SOP title Category Version Date issued Valid until Author(s) Approved by Modification history Contents: Purpose Scope Responsibility Procedure References Appendices

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC T16 Defining a quality assessment framework to improve data accuracy and completeness

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC Defining a quality assessment framework T16. Defining a quality assessment framework Data quality Features and characteristics of a data set, that bear on its ability to satisfy the needs that result from the intended use of the data. Quality Assurance (QA) Activities undertaken before data collection to ensure that the data are of the highest possible quality at the time of collection Quality Control (QC) Activities undertaken during and after data collection aimed at identifiying and correcting sources of data errors Quality Assessment (Qass) Process of quality evaluation of the consolidated database Quality Results (QR) Value or set of values resulting from applying a data quality measure Quality Indicators (QInd) List of quality measurements

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC Defining a quality assessment framework T16. Defining a quality assessment framework Quality DesignQuality Process QA (Quality Assurance)QC (Quality Control)QAss (Quality Assessment)QR (Quality Results) Quality assurance of: 1.Data:  Completeness of cover  Completeness of detail  Accuracy of detail  Accuracy of reporting  Accuracy of interpretation 2.Registry procedures (Procedure Manual) 3.Computerized systems 4.Security and confidentiality 5.Pilot Phase Design Necessity of:  Case-definition and case- inclusion/case-exclusion criteria  Sources of cases (analysis of sources of information)  List of co-variables, data dictionary and codification  Rules and documentation (Procedural Manual + Pilot Phase)  Good coding systems (only one code is allocated for each appropriate term)  Standards (Ex: maximum % tolerable error in sex, dates,...) Describe rules and procedures to measure and evaluate data quality in the following areas: 1.Completeness 2.Comparability 3.Validity of accuracy 4.Timeliness 5.Data source evaluation 6.Security and confidentiality Quality control measures can be:  Continuous: formal on-going program which forms part of the registry standard procedures (computer checks for data quality)  Occasional: ad hoc survey to address specific questions of data quality Achieved high-quality data. Periodic quality assessment of quality control activities. Finding and solving problems: Problems in case selection and case ascertainment Errors in coding, data entry, data transformation, accuracy Data consistency across sites and over time International errors Data security and confidentiality Follow-up (ex.: mortality) Timeliness (ensure quality data) Reporting Coordination  Internal and external assessment of procedures and quality control strategies  Use of standardized data report form (DRRF) 1.Validity of results 2.Timeliness (Data delivery) 3.Reporting  Internal and external validity: o Internal: without bias (accuracy of measurements) o External: consistency and coherence of results  Use of standardized data reporting QInd (Quality Indicators) Registry Establishment IndicatorsData Collection Indicators –Data accuracy and data completeness-Data result Indicators Goal: 1.Provide assessment of quality and disparity 2.Provide baselines to track progress 3.Identify information gaps 4.Emphasize interdependence 5.Emphasize interdependence of quality and disparities 6.Promote awareness and change

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC Defining a quality assessment framework T16. Defining a quality assessment framework Quality assessment plan Based on (or included in) the operating manual Pre-requisites for quality assessment Quality assurance activities: case-definition and inclusion criteria, minimum set of data, data dictionary, data collection protocols, data checks, training and motivation, … Quality control activities: assessment of completeness, accuracy of detail, validation checks, consistency checks, errors correction,… Quality assessment activities: data audits, variability analysis (by site and over time), validity audits, completeness of cover, … Quality improvement methods: feedback of quality reports, feedback of results and recommendations, timeliness, reporting, coordination,… Occasional ad-hoc measures Quality indicators list

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC Defining a quality assessment framework T16. Defining a quality assessment framework Arts DGT, De Keizer NF, Scheffer GJ. Defining and Improving Data Quality in Medical Registries: A Literature Review, Case Study, and Generic Framework. J Am Med Inform Assoc. 2002;9:600–11

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC Defining a quality assessment framework T16. Defining a quality assessment framework Register evaluation: Assessment of the public health importance of the topic (RD) Description of the systems used and their objectives Description of the uses and other outputs of the register Description of the resources used to operate the system Evaluation of the system against each of the register attributes Summary of whether the system is meeting its objectives and any modifications required Examination at intervals of the value of the register to ensure that the objectives still hold and being met.

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC Defining a quality assessment framework T16. Defining a quality assessment framework Define Purpose Develop Study Plan Design Protocol (SOPs development) Conduct Study Identify Improvement Opportunities Evaluate Improvements Implement Improvements (SOPs improvement) Report Study Findings QA QC QAss QR QA QC QAss Quality Control Quality Improvement Analyze Study Procedures Analyze Study Data QInd

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC T15/T16 Pilot study evaluation Assessment of proceduresMarch 2013 Set of common elements for developing SOPs Review of procedures and development of new ones Discussion and approval April-Juny 2013 Proposal of a quality indicators list Design of quality improvement methods Discussion and approval April-Juny 2013 Workplan proposal

Thank you very much! SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC