{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T17:45:13Z","timestamp":1778694313697,"version":"3.51.4"},"reference-count":22,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,7,15]],"date-time":"2022-07-15T00:00:00Z","timestamp":1657843200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,7,15]],"date-time":"2022-07-15T00:00:00Z","timestamp":1657843200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100002347","name":"Bundesministerium f\u00fcr Bildung und Forschung","doi-asserted-by":"publisher","award":["01ZZ1801A-M"],"award-info":[{"award-number":["01ZZ1801A-M"]}],"id":[{"id":"10.13039\/501100002347","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Universit\u00e4tsmedizin Greifswald"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Med Inform Decis Mak"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Data collected during routine health care and ensuing analytical results bear the potential to provide valuable information to improve the overall health care of patients. However, little is known about how patients prefer to be informed about the possible usage of their routine data and\/or biosamples for research purposes before reaching a consent decision. Specifically, we investigated the setting, the timing and the responsible staff for the information and consent process.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We performed a quasi-randomized controlled trial and compared the method by which patients were informed either in the patient admission area following patient admission by the same staff member (Group A) or in a separate room by another staff member (Group B). The consent decision was hypothetical in nature. Additionally, we evaluated if there was the need for additional time after the information session and before taking the consent decision. Data were collected during a structured interview based on questionnaires where participants reflected on the information and consent process they went through.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Questionnaire data were obtained from 157 participants in Group A and 106 participants in Group B. Overall, participants in both groups were satisfied with their experienced process and with the way information was provided. They reported that their (hypothetical) consent decision was freely made. Approximately half of the interested participants in Group B did not show up in the separate room, while all interested participants in Group A could be informed about the secondary use of their routine data and left-over samples. No participants, except for one in Group B, wanted to take extra time for their consent decision. The hypothetical consent rate for both routine data and left-over samples was very high in both groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The willingness to support medical research by allowing the use of routine data and left-over samples seems to be widespread among patients. Information concerning this secondary data use may be given by trained administrative staff immediately following patient admission. Patients mainly prefer making a consent decision directly after information is provided and discussed. Furthermore, less patients are informed when the process is organized in a separate room.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s12911-022-01922-6","type":"journal-article","created":{"date-parts":[[2022,7,15]],"date-time":"2022-07-15T18:03:35Z","timestamp":1657908215000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Secondary use of health care data and left-over biosamples within the \u2018Medical Informatics Initiative\u2019 (MII): a quasi-randomized controlled evaluation of patient perceptions and preferences regarding the consent process"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5987-9679","authenticated-orcid":false,"given":"Sybille","family":"Roschka","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Torsten","family":"Leddig","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mandy","family":"Bullerjahn","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gesine","family":"Richter","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wenke","family":"Liedtke","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin","family":"Langanke","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wolfgang","family":"Hoffmann","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,7,15]]},"reference":[{"issue":"3","key":"1922_CR1","doi-asserted-by":"publisher","first-page":"368","DOI":"10.14236\/jhi.v22i3.177","volume":"22","author":"S de Lusignan","year":"2015","unstructured":"de Lusignan S, Crawford L, Munro N. Creating and using real-world evidence to answer questions about clinical effectiveness. J Innov Health Inform. 2015;22(3):368\u201373.","journal-title":"J Innov Health Inform"},{"key":"1922_CR2","unstructured":"Medical Informatics Initiative Germany. Medical informatics: strengthening research and advancing healthcare. https:\/\/www.medizininformatik-initiative.de\/en\/start. Accessed 11 May 2020."},{"issue":"S 01","key":"1922_CR3","doi-asserted-by":"publisher","first-page":"e50","DOI":"10.3414\/ME18-03-0003","volume":"57","author":"SC Semler","year":"2018","unstructured":"Semler SC, Wissing F, Heyder R. German Medical Informatics Initiative. Methods Inf Med. 2018;57(S 01):e50\u20136.","journal-title":"Methods Inf Med"},{"key":"1922_CR4","doi-asserted-by":"publisher","first-page":"176","DOI":"10.1186\/s12967-015-0545-6","volume":"13","author":"M Bialke","year":"2015","unstructured":"Bialke M, Penndorf P, Wegner T, et al. A workflow-driven approach to integrate generic software modules in a Trusted Third Party. J Transl Med. 2015;13:176.","journal-title":"J Transl Med"},{"key":"1922_CR5","doi-asserted-by":"publisher","first-page":"86","DOI":"10.1186\/s12967-020-02257-4","volume":"18","author":"C Hampf","year":"2020","unstructured":"Hampf C, Geidel L, Zerbe N, et al. Assessment of scalability and performance of the record linkage tool E-PIX\u00ae in managing multi-million patients in research projects at a large university hospital in Germany. J Transl Med. 2020;18:86.","journal-title":"J Transl Med"},{"key":"1922_CR6","doi-asserted-by":"publisher","first-page":"256","DOI":"10.1186\/s12967-018-1631-3","volume":"16","author":"M Bialke","year":"2018","unstructured":"Bialke M, Bahls T, Geidel L, et al. MAGIC: once upon a time in consent management\u2014a FHIR\u00ae tale. J Transl Med. 2018;16:256.","journal-title":"J Transl Med"},{"key":"1922_CR7","doi-asserted-by":"publisher","first-page":"7","DOI":"10.1186\/s41231-021-00086-1","volume":"6","author":"C Hampf","year":"2021","unstructured":"Hampf C, Bialke M, Geidel L, et al. A survey on the current status and future perspective of informed consent management in the MIRACUM consortium of the German Medical Informatics Initiative. Transl Med Commun. 2021;6:7.","journal-title":"Transl Med Commun"},{"issue":"1","key":"1922_CR8","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/s40504-019-0096-3","volume":"16","author":"D Hallinan","year":"2020","unstructured":"Hallinan D. Broad consent under the GDPR: an optimistic perspective on a bright future. Life Sci Soc Policy. 2020;16(1):1.","journal-title":"Life Sci Soc Policy"},{"issue":"3","key":"1922_CR9","doi-asserted-by":"publisher","first-page":"226","DOI":"10.1093\/phe\/phr020","volume":"4","author":"M Sheehan","year":"2011","unstructured":"Sheehan M. Can broad consent be informed consent? Public Health Ethics. 2011;4(3):226\u201335.","journal-title":"Public Health Ethics"},{"issue":"9","key":"1922_CR10","doi-asserted-by":"publisher","first-page":"34","DOI":"10.1080\/15265161.2015.1062162","volume":"15","author":"C Grady","year":"2015","unstructured":"Grady C, Eckstein L, Berkman B, et al. Broad consent for research with biological samples: workshop conclusions. Am J Bioeth. 2015;15(9):34\u201342.","journal-title":"Am J Bioeth"},{"key":"1922_CR11","unstructured":"AG Consent des Nationalen Steuerungsgremiums der MII des BMBF. Handreichung zur Anwendung der national harmonisierten Patienteninformations- und Einwilligungsdokumente zur Sekund\u00e4rnutzung von Patientendaten, Version 1.6d vom 16.04.2020. https:\/\/www.medizininformatik-initiative.de\/sites\/default\/files\/2020-04\/MII_AG-Consent_Handreichung_v0.9d.pdf. Accessed 11 May 2020."},{"key":"1922_CR12","unstructured":"AG Consent des Nationalen Steuerungsgremiums der MII des BMBF. Begr\u00fcndung f\u00fcr eine krankheits\u00fcbergreifende Zweckbestimmung in den Einwilligungserkl\u00e4rungen der Medizininformatik-Initiative, Version 0.3 vom 21.09.2018. https:\/\/www.medizininformatik-initiative.de\/sites\/default\/files\/2018-11\/MII_AG-Consent_Begruendung-Krankheits\u00fcbergreifender-Consent.pdf. Accessed 11 May 2020."},{"key":"1922_CR13","unstructured":"AG Consent des Nationalen Steuerungsgremiums der MII des BMBF. 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Perspect Clin Res. 2017;8(3):107\u201312.","journal-title":"Perspect Clin Res"},{"issue":"5","key":"1922_CR16","doi-asserted-by":"publisher","first-page":"485","DOI":"10.1016\/S1470-2045(08)70128-1","volume":"9","author":"M Jefford","year":"2008","unstructured":"Jefford M, Moore R. Improvement of informed consent and the quality of consent documents. Lancet Oncol. 2008;9(5):485\u201393.","journal-title":"Lancet Oncol"},{"issue":"6","key":"1922_CR17","doi-asserted-by":"publisher","first-page":"841","DOI":"10.1038\/s41431-019-0340-6","volume":"27","author":"G Richter","year":"2019","unstructured":"Richter G, Borzikowsky C, Lieb W, Schreiber S, Krawczak M, Buyx A. Patient views on research use of clinical data without consent: legal, but also acceptable? 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Biopreserv Biobank. 2014;12(6):409\u201314.","journal-title":"Biopreserv Biobank"},{"issue":"9295","key":"1922_CR22","doi-asserted-by":"publisher","first-page":"1772","DOI":"10.1016\/S0140-6736(01)06805-2","volume":"358","author":"S Joffe","year":"2001","unstructured":"Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001;358(9295):1772\u20137.","journal-title":"Lancet"}],"container-title":["BMC Medical Informatics and Decision Making"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12911-022-01922-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12911-022-01922-6\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12911-022-01922-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,9,29]],"date-time":"2024-09-29T06:30:26Z","timestamp":1727591426000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcmedinformdecismak.biomedcentral.com\/articles\/10.1186\/s12911-022-01922-6"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,7,15]]},"references-count":22,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2022,12]]}},"alternative-id":["1922"],"URL":"https:\/\/doi.org\/10.1186\/s12911-022-01922-6","relation":{},"ISSN":["1472-6947"],"issn-type":[{"value":"1472-6947","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,7,15]]},"assertion":[{"value":"12 January 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 July 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"15 July 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study including the procedure for verbal consent was approved by the local Research Ethics Committee of the University Medicine Greifswald, Germany (Reg. No. BB 082\/19). All participants (patients or legal representatives, where applicable) provided informed verbal consent to participate in this study. To guarantee anonymity of our participants, no written consent documentation was created. By implementing a verbal consent for study participation, the simulation of the overall process (inpatient admission and subsequent conversation and interview for MII consent) was interrupted as little as possible and thus the validity of the data was threatened as little as possible. Study participants had the opportunity to discontinue their participation in the study at any time. Verbal information or non-answering of (further) questions was sufficient in this regard. Any consent given for the scientific use of routine health data and left-over biosamples remains purely hypothetical.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"184"}}