{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,6]],"date-time":"2026-04-06T20:03:49Z","timestamp":1775505829087,"version":"3.50.1"},"reference-count":6,"publisher":"BMJ","issue":"7","license":[{"start":{"date-parts":[[2023,7,27]],"date-time":"2023-07-27T00:00:00Z","timestamp":1690416000000},"content-version":"unspecified","delay-in-days":26,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010677","name":"H2020 Health","doi-asserted-by":"publisher","award":["733001"],"award-info":[{"award-number":["733001"]}],"id":[{"id":"10.13039\/100010677","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"published-print":{"date-parts":[[2023,7]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Linking healthcare data sets can create valuable resources for research, particularly when investigating rare exposures or outcomes. However, across Europe, the permissions processes required to access data can be complex. This paper documents the processes required by the EUROlinkCAT study investigators to research the health and survival of children with congenital anomalies in Europe.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Eighteen congenital anomaly registries in 14 countries provided information on all the permissions required to perform surveillance of congenital anomalies and to link their data on live births with available vital statistics and healthcare databases for research. Small number restrictions imposed by data providers were also documented.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The permissions requirements varied substantially, with certain registries able to conduct congenital anomaly surveillance as part of national or regional healthcare provision, while others were required to obtain ethics approvals or informed consent. Data linkage and analysis for research purposes added additional layers of complexity for registries, with some required to obtain several permissions, including ethics approvals to link the data. Restrictions relating to small numbers often resulted in a registry\u2019s data on specific congenital anomalies being unusable.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The permissions required to obtain and link data on children with congenital anomalies varied greatly across Europe. The variation and complexity present a significant obstacle to the use of such data, especially in large data linkage projects. Furthermore, small number restrictions severely limited the research that could be performed for children with specific rare congenital anomalies.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2023-071687","type":"journal-article","created":{"date-parts":[[2023,7,27]],"date-time":"2023-07-27T15:40:24Z","timestamp":1690472424000},"page":"e071687","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Ethics and legal requirements for data linkage in 14 European countries for children with congenital anomalies"],"prefix":"10.1136","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5998-2860","authenticated-orcid":false,"given":"Hugh","family":"Claridge","sequence":"first","affiliation":[]},{"given":"Joachim","family":"Tan","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1206-3637","authenticated-orcid":false,"given":"Maria","family":"Loane","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0430-2594","authenticated-orcid":false,"given":"Ester","family":"Garne","sequence":"additional","affiliation":[]},{"given":"Ingeborg","family":"Barisic","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4858-6456","authenticated-orcid":false,"given":"Clara","family":"Cavero-Carbonell","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0206-5874","authenticated-orcid":false,"given":"Carlos","family":"Dias","sequence":"additional","affiliation":[]},{"given":"Miriam","family":"Gatt","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5691-2987","authenticated-orcid":false,"given":"Susan","family":"Jordan","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4031-4915","authenticated-orcid":false,"given":"Babak","family":"Khoshnood","sequence":"additional","affiliation":[]},{"given":"Sonja","family":"Kiuru-Kuhlefelt","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2482-1690","authenticated-orcid":false,"given":"Kari","family":"Klungsoyr","sequence":"additional","affiliation":[]},{"given":"Olatz","family":"Mokoroa Carollo","sequence":"additional","affiliation":[]},{"given":"Vera","family":"Nelen","sequence":"additional","affiliation":[]},{"given":"Amanda J","family":"Neville","sequence":"additional","affiliation":[]},{"given":"Anna","family":"Pierini","sequence":"additional","affiliation":[]},{"given":"Hanitra","family":"Randrianaivo","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9437-2790","authenticated-orcid":false,"given":"Anke","family":"Rissmann","sequence":"additional","affiliation":[]},{"given":"David","family":"Tucker","sequence":"additional","affiliation":[]},{"given":"Hermien","family":"de Walle","sequence":"additional","affiliation":[]},{"given":"Wladimir","family":"Wertelecki","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7164-612X","authenticated-orcid":false,"given":"Joan K","family":"Morris","sequence":"additional","affiliation":[]}],"member":"239","published-online":{"date-parts":[[2023,7,27]]},"reference":[{"key":"2023072708401282000_13.7.e071687.1","doi-asserted-by":"crossref","unstructured":"Taylor JA , Crowe S , Espuny Pujol F , et al . The road to hell is paved with good intentions: the experience of applying for national data for linkage and suggestions for improvement. BMJ Open 2021;11:e047575. doi:10.1136\/bmjopen-2020-047575","DOI":"10.1136\/bmjopen-2020-047575"},{"key":"2023072708401282000_13.7.e071687.2","doi-asserted-by":"crossref","first-page":"539","DOI":"10.1111\/imj.14244","article-title":"Health data linkage research in Australia remains challenging","volume":"49","author":"Palamuthusingam","year":"2019","journal-title":"Intern Med J"},{"key":"2023072708401282000_13.7.e071687.3","doi-asserted-by":"publisher","DOI":"10.1111\/j.1475-6773.2010.01142.x"},{"key":"2023072708401282000_13.7.e071687.4","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2005.04.024"},{"key":"2023072708401282000_13.7.e071687.5","doi-asserted-by":"crossref","first-page":"785","DOI":"10.1016\/j.athoracsur.2018.04.049","article-title":"Surgical management and outcomes of Ebstein anomaly in neonates and infants: a society of thoracic surgeons congenital heart surgery database analysis","volume":"106","author":"Holst","year":"2018","journal-title":"Ann Thorac Surg"},{"key":"2023072708401282000_13.7.e071687.6","doi-asserted-by":"crossref","first-page":"677","DOI":"10.1017\/S1047951116001025","article-title":"The changing epidemiology of Ebstein\u2019s anomaly and its relationship with maternal mental health conditions: a European registry-based study","volume":"27","author":"Boyle","year":"2017","journal-title":"Cardiol Young"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2023-071687","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,7,27]],"date-time":"2023-07-27T15:40:33Z","timestamp":1690472433000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2023-071687"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,7]]},"references-count":6,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2023,7,27]]},"published-print":{"date-parts":[[2023,7]]}},"alternative-id":["10.1136\/bmjopen-2023-071687"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2023-071687","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,7]]}}}