{"text_format":"1","workbook":"xlsx","n_sheets":8,"sheets":["Introduction","Instructions for use","Methodological Information","Essential Standards","Additional Requirements","Output","Glossary and explanations","Data"],"not_rendered":{"charts":0,"images":2,"macros":1,"external_links":0,"defined_names":3,"comments":0,"pivot_tables":1},"unopened":[],"bounds":{"document_bytes":16777216,"sheet_cells":100000,"rows_first":2000,"rows_last":500,"rows_between":2000,"halvings":0,"cell_chars":16384,"cell_head_chars":4096},"cells_cut":0,"cells_raw":0,"read":"whole","date_system":"1900"}

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[null,null,"Introduction to REQueST ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"EUnetHTA WP5b standards in registries draft tool"]
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[null,null,null,null,null,null,"European Network for Health Technology Assessment | Joint Action 3 2016-2020 | www.eunethta.eu"]

{"sheet":"Instructions for use","index":1,"n_rows":46,"n_cols":19,"rows_kept":46,"cut":false,"hidden":false,"merged":[[7,2,7,18],[45,8,45,24]]}
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[null,null,"DRAFT - FOR PUBLIC CONSULTATION"]
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[null,null,"Instructions for use",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"EUnetHTA WP5b2 standards in registries draft tool"]
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[null,null,null,null,null,null,null,null,"European Network for Health Technology Assessment | Joint Action 3 2016-2020 | www.eunethta.eu"]

{"sheet":"Methodological Information","index":2,"n_rows":22,"n_cols":8,"rows_kept":22,"cut":false,"hidden":false,"merged":[[7,2,7,7]]}
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[null,null,"DRAFT - FOR PUBLIC CONSULTATION"]
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[null,null,"Methodological Information",null,null,null,null,"EUnetHTA WP5b standards in registries draft tool"]
[]
[null,null,"Instructions on how to complete the evaluation for 'Methodological Information':\n\nThis section of the survey is designed to collect information on the methodology used and the data contained in the registry. It should be used by the HTA agency, to make sure the methodology and data match the requirements of the HTA's 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 to decide whether or not the registry is suitable for the evidence development required."]
[]
[null,null,"Item number","Area","Item and format required\nTo be completed by the registry owner or using information provided by the registry","Does the information meet the HTA study's needs?\n(Select one option)\nTo be completed by the HTA/decision making body","#","Comments\nTo be completed by the HTA/decision making body"]
[null,null,1,"Type of registry","Specify the type of registry which defines the patient population (disease/condition, pharmaceutical, medical device, procedure, or other),  and all health interventions included in the registry.\nFree text",null,{"$f":"IF(F11=\"Satisfactory\",2,IF(F11=\"Needs development / clarification\",1,IF(F11=\"Unsure/pass\",0.5,IF(F11=\"Not suitable\",0,IF(F11=\"\",\"\")))))","v":""}]
[null,null,2,"Objectives and research questions","Specify the registry objectives and research questions covered by the registry.\nFree text",null,""]
[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",null,""]
[null,null,4,"Duration","Specify the start and, if relevant, final date of data collection (duration). Can the registry be used as a platform for prospective registry studies?\nNumeric",null,""]
[null,null,5,"Size","Provide the total number of patients included with the date when the number was calculated.\nNumeric\n\nProvide the percentage of the eligible patient population which has participated in the registry.\nPercentage",null,""]
[null,null,6,"Inclusion and exclusion criteria","Identify the inclusion and exclusion criteria.\nFree text",null,""]
[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,null,null,null,"European Network for Health Technology Assessment | Joint Action 3 2016-2020 | www.eunethta.eu"]

{"sheet":"Essential Standards","index":3,"n_rows":27,"n_cols":10,"rows_kept":27,"cut":false,"hidden":false,"merged":[[7,2,7,9]]}
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[null,null,"DRAFT - FOR PUBLIC CONSULTATION"]
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[null,null,"Essential Standards",null,null,null,null,null,null,"EUnetHTA WP5b standards in registries draft tool"]
[]
[null,null,"Instructions on how to complete the evaluation for 'Essential Standards':\n\nIf the data and methodology of the registry meet the HTA's needs, the registry is being evaluated against the essential standards.\nEssential 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 should not use the registry 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\nTo be completed by the registry owner or using information provided by the registry","Is the minimum standard met?\n(Select one option)\nTo be completed by the HTA/decision making body","#","Comments\nTo be completed by the HTA/decision making body"]
[null,null,8,"Registry protocol","Registry has a protocol.","Registry has developed a plan or protocol with specified objectives, target population, exposures of interest, primary and secondary outcomes, data sources and linkage 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 protocol.\nDocument file format",null,{"$f":"IF(H11=\"Satisfactory\",2,IF(H11=\"Needs development / clarification\",1,IF(H11=\"Unsure/pass\",0.5,IF(H11=\"Not suitable\",0,IF(H11=\"\",\"\")))))","v":""}]
[null,null,9,"Governance","Registry governance is in place.","At a minimum, steering committee or a governing body with equivalent responsibilities and a data quality team or a governing body with equivalent responsibilities are in place and specified. \nRegistry governance structure should not include employees of the relevant manufacturers, existence of financial contributions in the capital of the manufacturers concerned by the product(s), close relatives that have a position of responsibility within these manufacturing companies or close relatives  with financial interests in the capital of these manufactures.","Describe the registry governance structure.\nFree text",null,""]
[null,null,10,"Quality assurance","Registry has 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.\nFree text",null,""]
[null,null,11,"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.\nDocument file format",null,""]
[null,null,12,"Data collection","Data collection is decribed.","\nThe following information should be provided: information on reporting dynamics, what data needs to be collected and how, and access rights. ","Describe the data collection procedure.\nFree text",null,""]
[null,null,13,"Minimum data set","Registry has a defined minimum data set.","Registry has a defined minimum data set that is able 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.\n\n\n","Provide a minimum data set.\nDocument file format",null,""]
[null,null,14,"Data dictionary","Data set has a data dictionary or similar.","\nData 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\nData 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.\nDocument file format",null,""]
[null,null,15,"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 the national/international data standards that are used for organising, storing, managing or protecting the data sets.\nFree text",null,""]
[null,null,16,"Confounders","Potential confounders are identified.","Techniques to prevent or control the potential counfounders should be specified.","Specify your techniques to prevent or control the potential counfounders.\nFree text",null,""]
[null,null,17,"Data cleaning","\nPlan for cleaning the data is described.","Plan for cleaning the data needs to be described including the time required for cleaning after closure to data submission. The percentage of missing data for the core outcomes has been provided. Explanation whether the ommission of missing data may potentially bias results has been provided.  ","Describe the data cleaning plan.\nFree text",null,""]
[null,null,18,"Protection, security and safeguards","Data security risks, policies and procedures are described. ","The security controls specific for the registry should be specified. ","Describe in detail the data security risks, policies and procedures specific to the registry.\nFree text",null,""]
[null,null,19,"Informed consent","Protection of privacy rights is assured for the persons whose health-related data is recorded.","\nInformed consent document should explain to potential participants:\n• the nature and purpose of the registry,\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), please provide the document (document file format). Or, if regulations exist for the management of data in the absence of informed consent, describe (free text).",null,""]
[]
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[null,null,null,null,null,"European Network for Health Technology Assessment | Joint Action 3 2016-2020 | www.eunethta.eu"]

{"sheet":"Additional Requirements","index":4,"n_rows":19,"n_cols":9,"rows_kept":19,"cut":false,"hidden":false,"merged":[[7,2,7,8]]}
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[null,null,"DRAFT - FOR PUBLIC CONSULTATION"]
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[null,null,"Additional Requirements",null,null,null,null,null,"EUnetHTA WP5b standards in registries draft tool"]
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[null,null,"Instructions on how to complete the evaluation for Additional Requirements:\n\nAdditional Requirements are elements of good practice and evidence quality which are not always practical or feasible to achieve, but are 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 and the specific evidence gap.\nIn this section the HTA agency 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","In your judgement, does this meet your agency's standards?\n(Select one option)\nTo be completed by the HTA/decision making body","#","Comments\nTo be completed by the HTA/decision making body"]
[null,null,20,"Interoperability","Registry shares data with interested parties.\n1. Document file format\n2. Free text\n3. Free text\n4. Free text\n5. Free text","\n1. Data access and sharing procedures documentation is uploaded.\n2. Average time  for answering an information query is specified.\n3. Sharing registry data with interested parties from other countries and/or international organizations is clarified.\n4. Information about internationally agreed minimum data set is provided.\n5. Existence of specific fees in providing access to data is clarified.",null,{"$f":"IF(G11=\"Satisfactory\",2,IF(G11=\"Needs development / clarification\",1,IF(G11=\"Unsure/pass\",0.5,IF(G11=\"Not suitable\",0,IF(G11=\"\",\"\")))))","v":""}]
[null,null,21,"Data sources","All data sources are identified.\nPredefined, multiple choices. If ‘’Other’’ - Free text","\nSources of data are identified.  If the sources of data for the registry are not listed, please select ‘’Other’’ and describe the data sources in text.",null,{"$f":"IF(G12=\"Satisfactory\",2,IF(G12=\"Needs development / clarification\",1,IF(G12=\"Unsure/pass\",0.5,IF(G12=\"Not suitable\",0,IF(G12=\"\",\"\")))))","v":""}]
[null,null,22,"Ethics","An ethical committee is involved in governing the usage of data.\nFree text","\nConsideration of research ethics requirements has been reported. If a research ethics committee approved the working procedures/ protocols of the registry, the process of obtaining approval is described.",null,{"$f":"IF(G13=\"Satisfactory\",2,IF(G13=\"Needs development / clarification\",1,IF(G13=\"Unsure/pass\",0.5,IF(G13=\"Not suitable\",0,IF(G13=\"\",\"\")))))","v":""}]
[]
[]
[]
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[]
[null,null,null,null,null,"European Network for Health Technology Assessment | Joint Action 3 2016-2020 | www.eunethta.eu"]

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[null,null,"DRAFT - FOR PUBLIC CONSULTATION"]
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[null,null,"Output",null,null,null,"EUnetHTA WP5b standards in registries draft tool"]
[]
[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,"Unsure / pass"]
[]
[null,null,null,null,null,"Not suitable"]
[]
[]
[null,null,"Area","Item","Individual score","Area score","Maximum score"]
[null,null,"Methodological Information","1. Type of registry",{"$f":"'Methodological Information'!G11","v":""},{"$f":"SUM(E23:E29)","v":0},14]
[null,null,null,"2. Objectives and research questions",{"$f":"'Methodological Information'!G12","v":""}]
[null,null,null,"3. Setting",{"$f":"'Methodological Information'!G13","v":""},null,null,null,null,"."]
[null,null,null,"4. Duration",{"$f":"'Methodological Information'!G14","v":""}]
[null,null,null,"5. Size",{"$f":"'Methodological Information'!G15","v":""}]
[null,null,null,"6. Inclusion and exclusion criteria",{"$f":"'Methodological Information'!G16","v":""}]
[null,null,null,"7. Follow-up",{"$f":"'Methodological Information'!G17","v":""}]
[null,null,"Essential Standards","8. Registry protocol",{"$f":"'Essential Standards'!I11","v":""},{"$f":"SUM(E30:E41)","v":0},24]
[null,null,null,"9. Governance structure",{"$f":"'Essential Standards'!I12","v":""}]
[null,null,null,"10. Quality assurance",{"$f":"'Essential Standards'!I13","v":""}]
[null,null,null,"11. Financing",{"$f":"'Essential Standards'!I14","v":""}]
[null,null,null,"12. Data collection",{"$f":"'Essential Standards'!I15","v":""}]
[null,null,null,"13. Minimum data set",{"$f":"'Essential Standards'!I16","v":""}]
[null,null,null,"14. Data dictionary",{"$f":"'Essential Standards'!I17","v":""}]
[null,null,null,"15. Standard definitions, terminology and specifications",{"$f":"'Essential Standards'!I18","v":""}]
[null,null,null,"16. Confounders",{"$f":"'Essential Standards'!I19","v":""}]
[null,null,null,"17. Data cleaning",{"$f":"'Essential Standards'!I20","v":""}]
[null,null,null,"18. Protection, security and safeguards",{"$f":"'Essential Standards'!I21","v":""}]
[null,null,null,"19. Informed consent",{"$f":"'Essential Standards'!I22","v":""}]
[null,null,"Additional Requirements","20. Interoperability readiness",{"$f":"'Additional Requirements'!H11","v":""},{"$f":"SUM(E42:E44)","v":0},6]
[null,null,null,"21. Data sources",{"$f":"'Additional Requirements'!H12","v":""}]
[null,null,null,"22. Ethical committee",{"$f":"'Additional Requirements'!H13","v":""}]
[]
[]
[]
[]
[]
[null,null,null,"European Network for Health Technology Assessment | Joint Action 3 2016-2020 | www.eunethta.eu"]

{"sheet":"Glossary and explanations","index":6,"n_rows":34,"n_cols":7,"rows_kept":34,"cut":false,"hidden":false,"merged":[[33,4,33,5]]}
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[null,null,"DRAFT - FOR PUBLIC CONSULTATION"]
[]
[]
[null,null,"Glossary",null,null,null,"EUnetHTA WP5b standards in registries draft tool"]
[]
[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. Available from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf"]
[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 category or type to which your registry belongs with respect to its intended purpose(s). Provide information about the disease or condition, pharmaceutical product, device or diagnostic technology, or medical or surgical procedure of interest to your registry. In addition, specify the health interventions included in the registry.","Methodological information - REQueST. Categories developed for this programme of work"]
[null,null,"Objectives and research questions","Methodological Information","The objective is the question to be addressed through the registry which together achieve the overarching purpose(s) of the registry.\n\nThe research question is the purpose and objective of the registry shaped into a researchable question.","Specify the primary and secondary objectives and research questions of 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. Available from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf"]
[null,null,"Setting","Methodological Information","The geographical area 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).","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","Length of time that the registry is expected to collect data in order to achieve its purpose.","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 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,"Registry protocol","Essential Standards","The plan or set of steps to be followed in a study.","Documenting registry policies and procedures enables the registry to become more process dependent than person dependent, potentially enhancing data quality, stability and reliability. \n","http://htaglossary.net/protocol"]
[null,null,"Governance","Essential Standards","An organizational 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. Available from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.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 [Internet]. Available from: http://www.encepp.eu/standards_and_guidances/methodologicalGuide.shtml\nhttps://effectivehealthcare.ahrq.gov/sites/default/files/pdf/registries-guide-2nd-edition_research.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. Available from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf"]
[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. \n\nThe registry should find resources for continuous data collection. Also, the data recorded should address relevant efficacy and safety outcomes and important patient characteristics.\n\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. Available from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf    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 contains 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. Available from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf    https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/registries-guide-2nd-edition_research.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.\n\nThe data dictionary should define elements needed to answer the researche questions and objectives.","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. Available from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf"]
[null,null,"Confounders","Essential Standards","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,"Data cleaning","Essential Standards","Data control and cleaning of patient registries is the process by which erroneous data are removed or fixed and missing data are filled.","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. Available 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,"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. Available from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf"]
[null,null,"Interoperability readiness","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. Available 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. Available 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. Available from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/patient_registries_guidelines_en.pdf"]
[]
[]
[null,null,null,null,"European Network for Health Technology Assessment | Joint Action 3 2016-2020 | www.eunethta.eu"]

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