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[]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Acknowledgements"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,"The REQueST tool has been developed by the following EUnetHTA partners:"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Role",null,"Organisation"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Authors",null,"National Institute for Health and Care Excellence, NICE (UK)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Croatian Institute of Public Health, HZJZ (Croatia)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Agency for Health Quality and Assessment of Catalonia, AQuAS (Spain)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"French National Authority for Health (Haute Autorité de Santé), HAS (France) - work package lead"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Co-authors",null,"Italian Medicines Agency, AIFA (Italy)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Galician Agency for Health Technology Assessment, avalia-t (Spain)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"National Authority of Medicines and Health Products, INFARMED (Portugal)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Reviewers",null,"Agencia Española de Medicamentos y Productos Sanitarios, AEMPS (Spain)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Agenzia Nazionale per i Servizi Sanitari Regionali, Agenas (Italy)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Agency for Health Technology Assessment and Tariff System, AOTMiT (Poland)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Azienda Zero, AZIENDA (Italy)"]
[null,null,null,null,"Joint Action 3",null,null,null,null,null,null,null,null,null,null,null,"Ministero della Salute, DGFDM IT (Italy)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"National Evaluation Center of Quality and Technology, EKAPTY (Greece)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Finnish Medicines Agency, FIMEA (Finland)"]
[null,null,"MILESTONE",null,null,null,null,null,null,null,null,null,null,null,null,null,"Federal Office of Public Health, FOPH (Switzerland)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Institute for Quality and Efficiency in Health Care, IQWIG (Germany)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"National Institute of Health, ISS (Italy)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices, JAZMP (Slovenia)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"National Institute of Public Health, NIJZ (Slovenia)"]
[null,null,"Milestone 5.15 Final validated Standards Tool for Registries in HTA prepared ",null,null,null,null,null,null,null,null,null,null,null,null,null,"National Institute of Pharmacy and Nutrition, NIPN (Hungary)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Norwegian Medicines Agency, NoMA (Norway)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"National School of Public Health Management and Professional Development, NSPHMPDB (Romania)"]
[null,null,"Date of submission",null,null,"2019-09-30",null,null,null,null,null,null,null,null,null,null,"Swiss Network for Health Technology Assessment, SNHTA (Switzerland)"]
[null,null,"Work package",null,null,5,null,null,null,null,null,null,null,null,null,null,"Dental and Pharmaceutical Benefits Agency, TLV (Sweden)"]
[null,null,"Activity Centre",null,null,"Post-Launch Evidence Generation (PLEG) and Registries – Strand B2",null,null,null,null,null,null,null,null,null,null,"University Hospital A. Gemelli, UCSC GEMELLI (Italy)"]
[null,null,"Author(s)",null,null,"National Institute for Health and Care Excellence, NICE (UK)",null,null,null,null,null,null,null,null,null,null,"National Health Care Institute, ZIN (The Netherlands)"]
[null,null,null,null,null,"Croatian Institute of Public Health, HZJZ (Croatia)"]
[null,null,null,null,null,"Agency for Health Quality and Assessment of Catalonia, AQuAS (Spain)",null,null,null,null,null,null,null,null,"The following external organisations provided comments on the REQueST tool:"]
[null,null,null,null,null,"French National Authority for Health (Haute Autorité de Santé), HAS ",null,null,null,null,null,null,null,null,"Role",null,"Organisation"]
[null,null,null,null,null,"(France) - work package lead",null,null,null,null,null,null,null,null,"Stakeholder\nand/or\npublic\nconsultees",null,"Alliance for Regenerative Medicine, ARM"]
[null,null,"Dissemination level",null,null,"Public",null,null,null,null,null,null,null,null,null,null,"Analysis Group (USA)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"European Association of Hospital Pharmacists, EAHP"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry, COCIR"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"European Federation of Pharmaceutical Industries and Associations, EFPIA"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"European Federation of Statisticians in the Pharmaceutical Industry, EFSPI"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"European Forum for Primary Care, EFPC"]
[null,null,"Revision History",null,null,null,null,null,null,null,null,null,null,null,null,null,"European Free Trade Association, EFTA"]
[null,null,"Revision no.",null,"Date",null,"Author",null,null,null,null,null,null,null,null,null,"European Medicines Agency, EMA"]
[null,null,1,null,"2017-09-06",null,"Maja Valentić (MV) (HZJZ)",null,null,null,null,null,null,null,null,null,"European Organisation for Rare Diseases, EURORDIS"]
[null,null,2,null,"2017-12-22",null,"MV, Hannah Patrick (HP) (NICE)",null,null,null,null,null,null,null,null,null,"European Organisation for Research and Treatment of Cancer, EORTC"]
[null,null,5,null,"2018-07-12",null,"MV, HP, Helen Powell (HeP) (NICE), Irena Guzina (IG) (HAS)",null,null,null,null,null,null,null,null,null,"European Patients' Forum, EPF"]
[null,null,7,null,"2019-04-17",null,"HP, HeP",null,null,null,null,null,null,null,null,null,"European Public Health Association, EUPHA"]
[null,null,8,null,"2019-05-25",null,"MV, HP, HeP, Emmanuel Gimenez (EG) (AQuAS) ",null,null,null,null,null,null,null,null,null,"European Society of Cardiology, ESC"]
[null,null,9.1,null,"2019-05-03",null,"MV, HP, HeP, IG, Jae Long (JL) (NICE)",null,null,null,null,null,null,null,null,null,"European Union of General Practitioners, UEMO"]
[null,null,9.6999999999999993,null,"2019-09-30",null,"Maja Valentić (HZJZ), Hannah Patrick (NICE), Helen Powell (NICE), Irena Guzina (HAS)",null,null,null,null,null,null,null,null,null,"ICON Commercialisation & Outcomes (Ireland)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Office for Life Sciences, OLS (UK)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Red Argentina Pública de Evaluación de Tecnología Sanitaria (Argentina)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Synergus RWE (Sweden)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"University of Manchester (UK)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"University of Zurich (Switzerland)"]
[]
[null,null,"European Network for Health Technology Assessment | Joint Action 3 2016-2020 | www.eunethta.eu"]

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[]
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[null,null,"Introduction to REQueST ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Registry Evaluation and Quality Standards Tool (REQueST)"]
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[null,null,"European Network for Health Technology Assessment | Joint Action 3 2016-2020 | www.eunethta.eu"]

{"sheet":"Instructions for use","index":2,"n_rows":43,"n_cols":19,"rows_kept":43,"cut":false,"hidden":false,"merged":[[7,2,7,18],[42,2,42,18]]}
[]
[]
[]
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[null,null,"Instructions for use",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Registry Evaluation and Quality Standards Tool (REQueST)"]
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[null,null,"European Network for Health Technology Assessment | Joint Action 3 2016-2020 | www.eunethta.eu"]

{"sheet":"Methodological Information","index":3,"n_rows":24,"n_cols":10,"rows_kept":24,"cut":false,"hidden":false,"merged":[[7,2,7,8],[23,2,23,8]]}
[]
[]
[]
[]
[]
[null,null,"Methodological Information",null,null,null,null,null,"Registry Evaluation and Quality Standards Tool (REQueST)"]
[]
[null,null,"Instructions on how to complete the evaluation for 'Methodological Information':\n\nThis section of the tool is designed to collect information on the methodology used and the data contained in the registry. It should be used by the HTA agency or regulator, to make sure the methodology and data match the requirements of the evidence gap or research question(s). Although the questions do not provide insight into the quality of the registry, they should be answered in order to allow the HTA agency/regulator to decide whether or not the registry is suitable for the evidence development required."]
[]
[null,null,"Item number","Area","Item and format required\n","Column to be completed by the registry owner - with hyperlinks to relevant online documents where possible","Does the information meet the HTA agency/regulator's needs?\n(Select one option)\nTo be completed by the HTA agency/regulator","#","Comments\nTo be completed by the HTA agency/regulator"]
[null,null,1,"Type of registry","Specify the type of registry which defines the patient population, all the health interventions included in the registry and the registry objectives (primary and secondary).\nFree text/short summary  + online link",null,null,{"$f":"IF(G11=\"Satisfactory\",2,IF(G11=\"Needs development / clarification\",1,IF(G11=\"Not suitable\",0)))","v":false}]
[null,null,2,"Use for registry-based studies and previous publications","Can the registry be used as a platform for prospective registry-based studies? Provide weblink to publications.\nFree text/short summary + online link",null,null,false]
[null,null,3,"Geographical and organisational setting","Specify the geographical area of the registry and organisational setting. List the data providers (type of providers and the number of sites) participating in the registry.\nFree text/short summary + online link",null,null,false]
[null,null,4,"Duration","Specify the start and, if relevant, final date of data collection (duration). \nIndicate if the content (e.g. variables or coding) of the registry has changed in any significant way over time)\nNumeric and free text",null,null,false]
[null,null,5,"Size","Provide the total number of patients included in the registry. When was this number calculated?\nNumeric and date\nProvide the percentage of the patient population who meet selection criteria and who have participated in the registry.\nPercentage and free text explanation if necessary",null,null,false]
[null,null,6,"Inclusion and exclusion criteria","List the inclusion and exclusion criteria.\nFree text/short summary + online link",null,null,false]
[null,null,7,"Follow-up","Describe the methodology for the follow-up. What is the average follow-up period per patient in months? How do you predict and prevent loss to follow-up?\nFree text",null,null,false]
[null,null,8,"Confounders","Are data relating to potential confounders collected and identified for a specific registry use as appropriate. Specify techniques to prevent or control the potential confounders.\nFree text",null,null,false,null,{"$f":"IF(I18=\"Satisfactory\",2,IF(I18=\"Needs development / clarification\",1,IF(I18=\"Unsure/pass\",0.5,IF(I18=\"Not suitable\",0,IF(I18=\"\",\"\")))))","v":""}]
[]
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[null,null,"European Network for Health Technology Assessment | Joint Action 3 2016-2020 | www.eunethta.eu"]

{"sheet":"Essential Standards","index":4,"n_rows":28,"n_cols":11,"rows_kept":28,"cut":false,"hidden":false,"merged":[[7,2,7,10],[27,2,27,10]]}
[]
[]
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[]
[]
[null,null,"Essential Standards",null,null,null,null,null,null,null,"Registry Evaluation and Quality Standards Tool (REQueST)"]
[]
[null,null,"Instructions on how to complete the evaluation for 'Essential Standards':\n\nIf the data and methodology of the registry meet the HTA agency/regulator's needs, the registry is being evaluated against the 'Essential Standards'.\n'Essential Standards' are the minimum requirements for every registry. They are universal, essential elements of good practice and evidence quality. Unless all essential criteria are satisfactorily demonstrated to be met, the HTA agency/regulator should not use the register for evidence development.\nIn this section the evaluation is done by comparing the level of evidence given to the minimum essential standard.\n"]
[]
[null,null,"Item number","Area","Minimum standard","Assessment criteria","Item and format required\n","Column to be completed by the registry owner - with hyperlinks to relevant online documents where possible","Is the minimum standard met?\n(Select one option)\nTo be completed by the HTA agency/regulator","#","Comments\nTo be completed by the HTA agency/regulator"]
[null,null,9,"Registry aims and methodology","Registry has stated aims, objectives and methodology.","Registry has specified objectives, target population, exposures of interest, primary and secondary outcomes, data sources, linkage (and analysis plans if any). \nIf the documentation is more than 5 years old, the current status should be checked with the registry coordinator or participant.","Provide the registry documentation of aims, objectives and methodology.\nDocument file format",null,null,{"$f":"IF(I11=\"Satisfactory\",2,IF(I11=\"Needs development / clarification\",1,IF(I11=\"Not suitable\",0)))","v":false}]
[null,null,10,"Governance","Registry governance is in place.","An independent steering committee or a governing body and a data quality team with specified responsibilities are in place. These should include patient representation.\nRegistry governance should have an audited process for declarations of interest covering all financial contributions to the work. Employees of the relevant manufacturers, close relatives who have a position of responsibility within these manufacturing companies or close relatives with financial interests in the capital of these manufacturers could have a declared role in data analysis for the specified HTA project as long as the declared interests are considered not to affect the validity of the data.","Describe the registry governance structure. Provide documentation of the research ethics approval (or equivalent as appropriate) and all declarations of interest.\nFree text",null,null,false]
[null,null,11,"Informed consent","Protection of privacy rights is assured for the persons whose health-related data is recorded.","The informed consent document should explain to potential participants:\n• the nature, purpose of the registry and whether secondary analyses may be undertaken,\n• why they are candidates for participating in the registry,\n• what risks, benefits, and alternatives are associated with the participation\n• what rights they have as research subjects.\n\nIf the documentation is more than 5 years old, the current status should be checked with the registry holder.\n","If the registry requires individual informed consent for recording personal data (registry's primary purpose), provide the consent document (document file format). Or, if regulations exist for the management of data in the absence of informed consent, describe authorisation received for this.\nFree text",null,null,false]
[null,null,12,"Data dictionary","The data set has a data dictionary or similar.","The data dictionary should contain identifying attributes (name, ID), definitional attribute (definition of data element, where also the purpose of the data element is described), and representational attributes (permissible values, representation class, data type, format).\n\nThe data dictionary defines terms needed to answer the registry's research questions and objectives.\nIf the documentation is more than 5 years old, the current status should be checked with the registry coordinator or participant.","Provide a documented data dictionary. Check that the data dictionary can be expanded as necessary for a specific purpose.\nDocument file format",null,null,false]
[null,null,13,"Minimum data set","The registry has a defined minimum data set.","The registry has a defined minimum data set that is able to answer the registry’s research questions and objectives. If new fields are required for a specific purpose, the registry is able and willing to make the necessary changes.\nIf the documentation is more than 5 years old, the current status should be checked with the registry coordinator or participant.","Provide a minimum data set.\nDocument file format",null,null,false]
[null,null,14,"Standard definitions, terminology and specifications","Standard definitions, terminology and specifications are being used. ","Name of the standard, category of data (diagnosis, procedure, medication) and usage of the standard (organising, storing, managing or protecting the data sets) should be provided.","Specify national/international data standards used for organising, storing, managing and protecting the data sets.\nFree text",null,null,false]
[null,null,15,"Data collection","Data collection is described.","Data collection methods are realistic (e.g. software requirements acceptable to submitters)  for the proposed population and treating centres with clear access rights.","Describe the data collection procedure, pathway of submission, how data are submitted and access rights to the registry. \nFree text/flow chart",null,null,false]
[null,null,16,"Quality assurance","The registry has a quality assurance plan including assured delivery of continuous and comprehensive data submission.","Quality assurance activities relevant for the registry need to described.","Specify the quality assurance activities. Provide at a minimum details of data validation methods, accuracy checks, routine completeness and coverage estimates.\nFree text",null,null,false]
[null,null,17,"Data cleaning","A plan for cleaning the data is described. ","There is a plan for cleaning the data that includes the time required for cleaning after closure to data submission. ","Describe the data cleaning plan.\nFree text",null,null,false]
[null,null,18,"Missing data","A plan to manage missing data is described.","The percentage of missing data for the core outcomes has been provided. An explanation is given for whether missing data may potentially bias results. ","Describe the analytical plan for missing data (complete analysis or imputation?)\nFree text",null,null,false]
[null,null,19,"Financing","The financing of the registry is transparently presented.","Financial security to the end of the evidence development period should be demonstrated in the financial plan, solvency with a summary of income and expenditure for the previous 2 years is recommended. Also, funding sources are identified and the approx. proportions (%) of total sum from each funding source is indicated. \nIf the documentation is more than 5 years old, the current status should be checked with registry coordinator or participant.","Provide a financial plan (or similar) of the registry. Demonstrate financial security for proposed evidence development period.\nDocument file format",null,null,false]
[null,null,20,"Protection, security and safeguards","Data security risks, policies and procedures are described. The registry has a policy for data sharing.","The security controls specific for the registry should be specified. Risks should be identified and appropriate mitigation described. ","Describe in detail the data security risks, policies and procedures specific to the registry. \nFree text",null,null,false]
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[null,null,"European Network for Health Technology Assessment | Joint Action 3 2016-2020 | www.eunethta.eu"]

{"sheet":"Additional Requirements","index":5,"n_rows":19,"n_cols":10,"rows_kept":19,"cut":false,"hidden":false,"merged":[[7,2,7,9],[18,2,18,9]]}
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[null,null,"Additional Requirements",null,null,null,null,null,null,"Registry Evaluation and Quality Standards Tool (REQueST)"]
[]
[null,null,"Instructions on how to complete the evaluation for 'Additional Requirements':\n\n'Additional Requirements' are useful extra items of information, relevant to evidence quality but which are not always practical or feasible to achieve. They may be useful to consider in planning and evaluating registries for specific purposes. \nEvaluation of the 'Additional Requirements' depends on the requirements of an individual HTA agency or regulator and the specific evidence gap.\nIn this section the HTA agency/regulator  judges whether the level of evidence given is enough and whether the information meets its requirements.\n"]
[]
[null,null,"Item number","Area","Standard/requirement and format of the requested data","Assessment criteria","Column to be completed by the registry owner - with hyperlinks to relevant online documents where possible","Does the information meet the HTA agency/regulator's needs?\n(Select one option)\nTo be completed by the HTA agency/regulator","#","Comments\nTo be completed by the HTA agency/regulator"]
[null,null,21,"Interoperability and readiness for data linkage","Registry shares data with interested parties.\n1. Document file format\n2. Free text\n3. Free text\n4. Free text\n5. Free text","1. Data access and sharing procedures documentation are uploaded.\n2. Average time to answer an information query and to undertake data linkage is specified.\n3. Statements regarding usage of data and consent for data sharing (and with whom) are provided. These cover sharing of registry data with interested parties from other countries and/or international organisations.\n4. Technical standards, data structure, and standard sets for measuring health outcomes and Internationally agreed minimum data set is specified.\n5. Existence of specific fees in providing access to data and data linkage are clarified.",null,null,{"$f":"IF(H11=\"Satisfactory\",2,IF(H11=\"Needs development / clarification\",1,IF(H11=\"Not suitable\",0)))","v":false}]
[null,null,22,"Data sources","All data sources are identified.\nPredefined, multiple choices. If 'Other' - Free text","Sources of data are identified. If the sources of data for the registry are not listed, please select 'Other' and describe the data sources in text. ",null,null,{"$f":"IF(H12=\"Satisfactory\",2,IF(H12=\"Needs development / clarification\",1,IF(H12=\"Not suitable\",0)))","v":false}]
[null,null,23,"Ethics","An ethical committee is involved in governing the usage of data.\nFree text","Consideration of research ethics requirements has been reported. If a research ethics committee approved the working procedures/ methodology of the registry, the process of obtaining approval is described.",null,null,{"$f":"IF(H13=\"Satisfactory\",2,IF(H13=\"Needs development / clarification\",1,IF(H13=\"Not suitable\",0)))","v":false}]
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[null,null,"European Network for Health Technology Assessment | Joint Action 3 2016-2020 | www.eunethta.eu"]

{"sheet":"Output","index":6,"n_rows":48,"n_cols":10,"rows_kept":48,"cut":false,"hidden":false,"merged":[[19,6,25,6],[27,6,38,6],[39,6,41,6],[40,2,41,2],[47,2,47,4],[27,5,38,5],[39,5,41,5],[7,2,7,5],[19,5,25,5]]}
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[null,null,"Output",null,null,null,"Registry Evaluation and Quality Standards Tool (REQueST)"]
[]
[null,null,"Instructions\n\nIndividual scores are automatically copied from the 'Methodological Information', 'Essential Standards' and 'Additional Requirements' worksheets. The area score is automatically generated by the tool."]
[]
[null,null,"Registry name:","[Registry holder to complete]"]
[null,null,"Date of assessment:","[Registry holder to complete]"]
[]
[null,null,null,"Key:",null,"Satisfactory"]
[]
[null,null,null,null,null,"Needs development / clarification"]
[]
[null,null,null,null,null,"Not suitable"]
[]
[null,null,"Area","Item","Colour rating"]
[null,null,"Methodological Information","1. Type of registry",{"$f":"'Methodological Information'!H11","v":false}]
[null,null,null,"2. Use for registry-based studies and previous publications",{"$f":"'Methodological Information'!H12","v":false}]
[null,null,null,"3. Geographical and organisational setting",{"$f":"'Methodological Information'!H13","v":false},null,null,null,null,"."]
[null,null,null,"4. Duration",{"$f":"'Methodological Information'!H14","v":false}]
[null,null,null,"5. Size",{"$f":"'Methodological Information'!H15","v":false}]
[null,null,null,"6. Inclusion and exclusion criteria",{"$f":"'Methodological Information'!H16","v":false}]
[null,null,null,"7. Follow-up",{"$f":"'Methodological Information'!H17","v":false}]
[null,null,null,"8. Confounders",{"$f":"'Methodological Information'!H18","v":false}]
[null,null,"Essential Standards","9. Registry aims and methodology",{"$f":"'Essential Standards'!J11","v":false}]
[null,null,null,"10. Governance",{"$f":"'Essential Standards'!J12","v":false}]
[null,null,null,"11. Informed consent",{"$f":"'Essential Standards'!J13","v":false}]
[null,null,null,"12. Data dictionary",{"$f":"'Essential Standards'!J14","v":false}]
[null,null,null,"13. Minimum data set",{"$f":"'Essential Standards'!J15","v":false}]
[null,null,null,"14. Standard definitions, terminology and specifications",{"$f":"'Essential Standards'!J16","v":false}]
[null,null,null,"15. Data collection",{"$f":"'Essential Standards'!J17","v":false}]
[null,null,null,"16. Quality assurance",{"$f":"'Essential Standards'!J18","v":false}]
[null,null,null,"17. Data cleaning",{"$f":"'Essential Standards'!J19","v":false}]
[null,null,null,"18. Missing data",{"$f":"'Essential Standards'!J20","v":false}]
[null,null,null,"19. Financing",{"$f":"'Essential Standards'!J21","v":false}]
[null,null,null,"20. Protection, security and safeguards",{"$f":"'Essential Standards'!J22","v":false}]
[null,null,"Additional Requirements","21. Interoperability and readiness for data linkage",{"$f":"'Additional Requirements'!I11","v":false}]
[null,null,null,"22. Data sources",{"$f":"'Additional Requirements'!I12","v":false}]
[null,null,null,"23. Ethics",{"$f":"'Additional Requirements'!I13","v":false}]
[]
[]
[]
[]
[]
[null,null,"European Network for Health Technology Assessment | Joint Action 3 2016-2020 | www.eunethta.eu"]

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[null,null,"Glossary and explanations",null,null,null,"Registry Evaluation and Quality Standards Tool (REQueST)"]
[]
[null,null,"Term","Area","Definition","Explanation for use in REQueST","Reference source"]
[null,null,"Registry","General","An organised system that collects data and information on a group of people defined by a particular disease, condition, exposure or health-related service and followed over time, and that serves a pre-determined scientific, clinical and/or public health (policy) purpose.","'Registry' is the organisation and system that supports one or a number of individual databases or 'registers'. In the EUnetHTA JA3 WP5B deliverables, the term 'register' will be used only to indicate the list of items, names or other data of interest.","Zaletel M, Kralj M (Eds). Methodological guidelines and recommendations for efficient and rational governance of patient registries. 2015. National Institute of Public Health, Ljubljana.\nAvailable from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf\n\nhttps://www.ema.europa.eu/en/human-regulatory/post-authorisation/patient-registries"]
[null,null,"Registry-based study protocol","General","The plan or set of steps to be followed in a study.","The methodology of registry-based studies should be consistent with the registry policies and procedures.\n","http://htaglossary.net/protocol\n\nENCePP, European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ENCePP Guide on Methodological Standards in Pharmacoepidemiology. \nAvailable from: http://www.encepp.eu/standards_and_guidances/methodologicalGuide.shtml"]
[null,null,"Type of registry","Methodological Information","REQueST uses the following patient registry classifications: \n• A disease or condition registry is a registry defined by patients with a common disease or condition. \n• A pharmaceutical registry is a registry defined by patients who take or have taken a particular pharmaceutical product. \n• A medical technology registry is a registry defined by patients who have been exposed to a particular device or diagnostic technology.\n• A procedural registry is a registry defined by patients who have undergone a particular medical or surgical procedure.\nOther registries collect patient data relating to a health-related service, reimbursement/ insurance/sales information, inclusion in a clinical trials or receiving routine care.","Specify the type of registry which defines the patient population, all health interventions included in the registry, and the registry objectives (primary and secondary).","Methodological information - REQueST. Categories developed for this programme of work.\n\nENCePP, European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ENCePP Resources Database. \nAvailable from: http://www.encepp.eu/encepp/resourcesDatabase.jsp"]
[null,null,"Use for registry-based studies and previous publications","Methodological Information","The registry should have primary and secondary objectives. ","The registry objectives may include the possibility of running a registry-based study which would have its own aims and objectives (consistent with those of the registry but usually answering a specific research question or evidence gap).","Zaletel M, Kralj M (Eds). Methodological guidelines and recommendations for efficient and rational governance of patient registries. 2015. National Institute of Public Health, Ljubljana. \nAvailable from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf\n\nhttp://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-160930-principles-system-registries.pdf"]
[null,null,"Geographical and organisational setting","Methodological Information","The geographical area and organisational setting from which the registry recruits investigators and patients as well as collects data.\nExamples of types of data providers: Clinical units (within hospitals, practices, outpatient clinics etc); Laboratories/central services (biochemistry, pathological services, genetic, Rx, etc); Discharge registries; Patients and families; Patients’ groups (associations/federations); Disability registries; Centres of expertise; Birth registries; Cause of death registries; Insurance funds (public and private). REQueST was originally designed as a tool for Health Technology Assessment (HTA) but its principles are applicable to regulatory and academic work and therefore it may be used in wide contexts.  ","Specify whether the registry is run on local, national or international level and which geographical area the registry covers. Also provide the type of data providers participating in the registry.","https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/registries-guide-2nd-edition_research.pdf"]
[null,null,"Duration","Methodological Information","Specify the start and, if relevant, final date of data collection (duration). \nIndicate if the content (e.g. variables or coding) of the registry has changed in any significant way over time).","No additional explanation.","https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/registries-guide-2nd-edition_research.pdf"]
[null,null,"Size","Methodological Information","Description of the absolute number and proportion of the eligible population which is recruited into the registry.","No additional explanation.","https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/registries-guide-2nd-edition_research.pdf"]
[null,null,"Inclusion and exclusion criteria","Methodological Information","The inclusion criteria are the set of conditions that a patient must meet to be eligible for inclusion in a registry, and generally include geographic, demographic, disease-specific, time-specific, laboratory-specific, and other criteria. \nThe exclusion criteria are the criteria that disqualify patients from inclusion in the registry.","An example of how to answer this item:\n\nRegistry example: The Pulmonary Fibrosis Foundation Patient Registry (source: https://www.pulmonaryfibrosis.org/medical-community/pff-patient-registry)\n\nInclusion criteria:\n1. 18 years old or older. \n2. Understand and sign the informed consent document.\n3. ILD diagnosis must be made/confirmed at a participating Registry center. \na. The diagnostic evaluation must include, at a minimum, a medical history, physical examination, pulmonary function testing and a computerized tomography (CT) scan of the chest. \nb. If patients exhibit another pulmonary disease (such as emphysema or asthma), the primary disease must be ILD. \n4. Anticipated additional follow up at the Registry center within one year. \n\nExclusion Criteria \n1. Diagnosed with: \na. Sarcoid \nb. Lymphangioleiomyomatosis (LAM) \nc. Pulmonary alveolar proteinosis (PAP) \nd. Cystic fibrosis (CF) \ne. Amyloidosis.\n","Zaletel M, Kralj M (Eds). Methodological guidelines and recommendations for efficient and rational governance of patient registries. 2015. National Institute of Public Health, Ljubljana. Available from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf"]
[null,null,"Follow-up","Methodological Information","The period of patient observation for a registry. It can be sub-classified as follows:\n• Active follow-up is the period of registry patient observation where information is obtained directly from the registry patients.\n• Passive follow-up is the period of registry patient observation where information is obtained from linkage to existing database.\n\n\n\n\n\n","The methodology for the follow-up can be described as active follow-up, passive follow-up or mixed follow-up. ","Zaletel M, Kralj M (Eds). Methodological guidelines and recommendations for efficient and rational governance of patient registries. 2015. National Institute of Public Health, Ljubljana. Available from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf"]
[null,null,"Confounders","Methodological Information","Confounding factors are variables that influence both the exposure to treatment and the outcome in the analyses and can confuse analysis, results and interpretation of causality.","Confounding can include patient factors, provider factors, and system factors. Control of confounding factors can be done in the design and analysis phases. While it is not possible to identify all confounding factors in the advance of data construction, it is desirable to give serious thought to what will be important and how the necessary data can be collected.","https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/registries-guide-2nd-edition_research.pdf"]
[null,null,"Registry aims and methodology","Essential Standards","The stated aims, objectives and methodology of the registry.","Documenting registry policies and procedures enables the registry to become more process dependent than person dependent, potentially enhancing data quality, stability and reliability. ","Zaletel M, Kralj M (Eds). Methodological guidelines and recommendations for efficient and rational governance of patient registries. 2015. National Institute of Public Health, Ljubljana.\nAvailable from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf\n\nENCePP, European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ENCePP Guide on Methodological Standards in Pharmacoepidemiology. \nAvailable from: http://www.encepp.eu/standards_and_guidances/methodologicalGuide.shtml"]
[null,null,"Governance","Essential Standards","An organisational foundation of patient registries, mostly concerned with guidance and decision making. ","Registries fulfil governance roles in a variety of ways, for example, through a project management team, clinical/subject matter board, scientific committee, data collection and database management board, legal/patient privacy team, quality assurance team etc. Many of the roles could be assumed by a single committee (e.g., a steering committee). Whichever model is adopted, it must accommodate all of the working constituencies and provide a mechanism for those individuals to work together to achieve the goals of the registry. \n\nManaging conflicts of interest is vital to transparency of governance.\n\n\n","Zaletel M, Kralj M (Eds). Methodological guidelines and recommendations for efficient and rational governance of patient registries. 2015. National Institute of Public Health, Ljubljana.\nAvailable from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf"]
[null,null,"Informed consent","Essential Standards","A person's agreement to allow personal data to be provided to the registry. ","Securing the privacy of the patients or research subjects is an essential task when establishing and maintaining a patient registry or when conducting registry-based research. Moreover, when processing personal data, the data controller has to take into account not only legal, but also ethical perspectives. Informed consent refers to a person's agreement to allow personal data to be provided for the registry. ","Zaletel M, Kralj M (Eds). Methodological guidelines and recommendations for efficient and rational governance of patient registries. 2015. National Institute of Public Health, Ljubljana. \nAvailable from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf"]
[null,null,"Data dictionary","Essential Standards","Set of information describing the data elements and how those data elements are interpreted. The data dictionary contains a detailed description of each variable used by the registry, including the source of the variable, coding information if used, and normal ranges if relevant. ","Data elements should be well-documented and readily accessible to everyone who is interested in a registry’s data set. Well-documented and transparent data elements give an understanding of the collected data and ensure consistency in the data collection process. Therefore it is important that a registry establishes an inventory of all data elements/variables included in the registry.\nThe data dictionary should define elements needed to answer the research questions and objectives.","https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/registries-guide-2nd-edition_research.pdf"]
[null,null,"Minimum data set","Essential Standards","List of data elements/variables that are essential to collect the data for any case/subject.","As a minimum, registry planners must account for the minimum data set when calculating the resource needs and overall design of the registry. \nIt is recommended that a minimum data set should contain the following information: identifying attributes (name, ID), definitional attribute (definition of data element, where also the purpose of the data element is described), and representational attributes (permissible values, representation class, data type, format). ","Zaletel M, Kralj M (Eds). Methodological guidelines and recommendations for efficient and rational governance of patient registries. 2015. National Institute of Public Health, Ljubljana.\nAvailable from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf\n https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/registries-guide-2nd-edition_research.pdf"]
[null,null,"Standard definitions, terminology and specifications","Essential Standards","Essential standards are common registry data elements which facilitate consistency, comparability, data exchange and reuse.","It is important to ensure that the specifications of the data are consistent with national and international data standards. This avoids duplication of effort and the development of conflicting data standards. Designing the registry with respect to national and international standards is essential for improving data quality. \nSome examples of data standards are: terminology standards (CTS2 standard, SNOMED-CT, ICD10, ATC, LOINC, ICPC-2, ICHI, ICF, DRG), structure/exchange standards (OpenEHR, HL7 RIM CDA, C-CDA, HL7 FHIR, I2b2, ISO/CEN 13606, Clinical information modelling initiative), metadata standards (ISO/CEN Metadata standard 11179, Dublin Core Metadata).\n","Zaletel M, Kralj M (Eds). Methodological guidelines and recommendations for efficient and rational governance of patient registries. 2015. National Institute of Public Health, Ljubljana. \nAvailable from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf\n                                                                                                                                                                                                                                                                                             https://www.ichom.org/"]
[null,null,"Data collection","Essential Standards","The process of gathering data to get a complete and accurate picture of an area of interest of the registry.","The registry should have a detailed procedure plan for the entire data collection and provide methodological guides/standard instructions and rules for data collectors/providers and other data users. This typically includes information on reporting dynamics, which data need to be collected and how, means of data transmission, established controls for the acquired data (e.g. readability of data, adequacy of records and their number) and access rights. \nThe registry should find resources for continuous data collection. \n\n\n\n","Zaletel M, Kralj M (Eds). Methodological guidelines and recommendations for efficient and rational governance of patient registries. 2015. National Institute of Public Health, Ljubljana.\nAvailable from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf \n\nhttps://effectivehealthcare.ahrq.gov/sites/default/files/pdf/registries-guide-2nd-edition_research.pdf"]
[null,null,"Quality assurance","Essential Standards","Quality standards for the registry data, procedures and computerised systems to be followed in order to meet the quality requirements.","Registry planners should consider how to ensure quality to a level sufficient for the intended purpose(s) and how to develop appropriate quality assurance plans for their registries. Those conducting the registry should assess and report on those quality assurance activities.","ENCePP, European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ENCePP Guide on Methodological Standards in Pharmacoepidemiology. \nAvailable from: http://www.encepp.eu/standards_and_guidances/methodologicalGuide.shtml\n\nhttps://effectivehealthcare.ahrq.gov/sites/default/files/pdf/registries-guide-2nd-edition_research.pdf"]
[null,null,"Data cleaning","Essential Standards","Data control and cleaning of patient registries is the process by which erroneous data are removed or fixed.","The plan for cleaning the data should take into account the following types of data anomalies: lack of data, duplicates, data inconsistency and out-of-range values. Data quality reporting should include assessments of population coverage, validity and reliability of measurements.","Zaletel M, Kralj M (Eds). Methodological guidelines and recommendations for efficient and rational governance of patient registries. 2015. National Institute of Public Health, Ljubljana.\nAvailable from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf"]
[null,null,"Missing data  ","Essential Standards","The process by which missing data are filled.","Missing data should be treated with care to avoid the potential introduction of bias. The analytical plan for missing data (complete analysis or imputation) should take into account the size of the data set and the reasons why data are missing (random or otherwise). Linking to external databases can provide a source to fill missing values. Special codes or flag variables should be set to distinguish corrected fields.","Zaletel M, Kralj M (Eds). Methodological guidelines and recommendations for efficient and rational governance of patient registries. 2015. National Institute of Public Health, Ljubljana.\nAvailable from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf"]
[null,null,"Financing","Essential Standards","Financial resources used to ensure the sustainability, continued relevance and maximum impact of the data for which the registry coordinators are responsible. ","The financial plan should take into account initial development of the registry including infrastructure, database, user training costs, etc., and longer-term maintenance including periodic evaluations and additional analyses. \n\n\n\n","Zaletel M, Kralj M (Eds). Methodological guidelines and recommendations for efficient and rational governance of patient registries. 2015. National Institute of Public Health, Ljubljana. \nAvailable from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf"]
[null,null,"Protection, security and safeguards","Essential Standards","Measures implemented in order to maintain the privacy of participants enrolled in a registry and data confidentiality.","All security measures should be contained in a document that describes in detail the data security risks, policies, and procedures specific to that registry. International standard ISO/IEC 27002 includes a range of activities related to security policies, processes, procedures, organisational structures, software and hardware. Some of the controls are: \na) Administrative information security policy controls which provide direction and support for information security, in accordance with business and legal requirements, and initiate the implementation and operation of information security within registry systems; (b) Human resource security controls which ensure that staff and contractors understand their responsibilities; (c) Access controls which limit access to information and information processing facilities; (d) Cryptography controls which ensure proper and effective use of cryptography in order to protect the confidentiality, authenticity and/or integrity of information; (e) Physical and environmental security controls which prevent unauthorised physical access and damage to, as well as interference with information and information processing facilities. ","https://www.iso27001security.com/html/27002.html#StructureAndFormatOfISO17799"]
[null,null,"Interoperability and readiness for data linkage","Additional Requirements","In the broadest sense, stands for “ability to operate with others”. It can be applied to any situation where two or more entities achieve their goals or purpose by successfully interchanging services.","Sharing registry data with other interested parties signifies the registry's willingness to connect with others for mutual benefit, along with a certain level of interoperability. \n\nProcedures for granting access to or sharing data in a cross-border context must be in place, preferably including pre-defined response time targets. An organisational culture oriented towards, as well as appreciative of, data utilisation beyond its own remits, combined with appropriate resourcing are essential elements in achieving a high level of preparedness. Collaboration with other registry holders is advisable, in order to exchange experiences, advice and ideas. ","Zaletel M, Kralj M (Eds). Methodological guidelines and recommendations for efficient and rational governance of patient registries. 2015. National Institute of Public Health, Ljubljana. \nAvailable from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf"]
[null,null,"Data sources"," Additional Requirements","Modes of data collection for the registry.","The registry should take into account the technological aspect of data collection (e.g. paper-based forms, web-based data entry) and be aware of advantages and disadvantages of both paper-based and electronic approaches. Important characteristics of paper-based methods is that they are inexpensive and easy to create and develop, but in the registry’s whole process they involve a substantial cost because they need to be recorded in an electronic way. Although the design of bespoke electronic solutions can be expensive, their advantages are those of connectivity, error minimisation and reduction of duplication.","Zaletel M, Kralj M (Eds). Methodological guidelines and recommendations for efficient and rational governance of patient registries. 2015. National Institute of Public Health, Ljubljana. \nAvailable from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf"]
[null,null,"Ethical committee","Additional Requirements","Group of people whose role is advising on the efficient and secure collection and sharing of health information, evaluating information resources and publishing information about the delivery and performance of a registry","While this aspect is not critical in a functional sense, there is an obligation to ensure that the registry complies with relevant ethical requirements. ","Zaletel M, Kralj M (Eds). Methodological guidelines and recommendations for efficient and rational governance of patient registries. 2015. National Institute of Public Health, Ljubljana.\nAvailable from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf"]
[]
[null,null,"European Network for Health Technology Assessment | Joint Action 3 2016-2020 | www.eunethta.eu"]

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[null,null,"FAQs","Registry Evaluation and Quality Standards Tool (REQueST)"]
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[null,null,"Question","Response"]
[null,null,"Who by, and for what purposes, is the tool designed to be used?","REQueST is designed to be used by i) registry owners to assess the quality of their registry, and ii) international organisations considering whether to use registry data in evidence development for HTA and regulatory monitoring. The purpose is to highlight areas of a registry that need improvement in order to maximise the quality of its data and ensure that those data can be used for HTA and regulatory purposes."]
[null,null,"Will REQueST be used to generate evidence for HTA agencies or regulators, or to evaluate evidence submitted by others to those bodies.","REQueST is designed to enable registry owners to develop robust data collection and analyses for use by HTA agencies and regulators. In line with this it should be used by HTA agencies and regulators to transparently assess the quality of data from registries. "]
[null,null,"What should the requirements for acceptance of criteria be? ","Evaluation is done by comparing the information provided by the registry to the standard set out in the tool. The rigor of requirements should be appropriate to the nature of the technology and circumstance. They may increase as the phases of development are implemented. NB the reader should consult the vision paper for more information on the phases. "]
[null,null,"Are confounding data considered in REQueST, and how?","It is not possible to identify specific confounders for a whole registry. Confounders apply rather for registry-based studies addressing specific research questions. However, there may be cases in which confounders can be identified a priori. In registry-based studies, data are needed to distinguish between objectives of a descriptive nature like treatment patterns or prevalence or incidence of a condition, and studies with comparative effectiveness purposes where confounding is an important consideration."]
[null,null,"Is REQueST evidence based?","PARENT is the main evidence reference for REQueST - further explanations are provided in the 'Glossary and explanations' worksheet."]
[null,null,"Is REQueST designed to assess registry-based studies or Registries?","REQueST is designed to assess the quality of registries. Additional work would be required to review a proposed registry based study."]
[null,null,"How does REQueST fit into the landscape of emerging guidance on registries?","REQueST is designed to be a simple tool that is based on international published guidance on registry methodology. It provides a transparent, clear summary of the strengths and weaknesses of a registry that users may wish to approach for purposes such as registry based studies, audit, simple data collection etc."]
[null,null,"The 'Additional Requirements' should be essential. Why are they not all listed under 'Essential Standards'?","The issues are covered at a basic level in Essential Standards but more, study-specific requirements may be required e.g. not all registry data are intended to be shared across borders and not all registry data require research ethics approval (if intended for audit purposes only)."]
[]
[null,null,"European Network for Health Technology Assessment | Joint Action 3 2016-2020 | www.eunethta.eu"]

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