{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T11:02:04Z","timestamp":1789556524109,"version":"build-2803163510"},"reference-count":30,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2026,4,4]],"date-time":"2026-04-04T00:00:00Z","timestamp":1775260800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Health South-East research programme in Norway","award":["2017205"],"award-info":[{"award-number":["2017205"]}]},{"DOI":"10.13039\/501100005416","name":"Research Council of Norway","doi-asserted-by":"publisher","award":["302454"],"award-info":[{"award-number":["302454"]}],"id":[{"id":"10.13039\/501100005416","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007405","name":"Danish Heart Foundation","doi-asserted-by":"publisher","award":["18-R124-A8323-22091"],"award-info":[{"award-number":["18-R124-A8323-22091"]}],"id":[{"id":"10.13039\/100007405","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100009708","name":"Novo Nordisk Foundation","doi-asserted-by":"publisher","award":["NNF18OC0034582"],"award-info":[{"award-number":["NNF18OC0034582"]}],"id":[{"id":"10.13039\/501100009708","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,9,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Registry-based randomized clinical trials are increasingly applied in clinical research, providing advantages in feasibility and data capture. However, registry-based data may introduce bias through misclassification or missing information.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and results<\/jats:title>\n                    <jats:p>In the BETAMI-DANBLOCK trial, 5574 patients with myocardial infarction (MI) and no heart failure were randomized to beta-blocker or no beta-blocker therapy. The primary endpoint events (all-cause mortality, MI, ischemic stroke, heart failure, unplanned coronary revascularization, and malignant ventricular arrhythmias) were identified from the Danish\/Norwegian national patient registries, self-reported questionnaires, and medical records. All registry-identified events, except all-cause mortality, underwent blinded adjudication. We compared non-adjudicated and adjudicated events by calculating incidence rates and hazard ratios (HRs) for beta-blocker therapy vs. controls. National registries captured 99.7% of primary endpoint events registered by self-report and medical records. Of the primary endpoint events identified through the registries, 75% were confirmed by adjudication (incidence rate 6.23 vs. 4.43\/100 person-years). The confirmation rate was lower during the first 6 months and varied by event type (from 92% for ischaemic stroke to 45% for unplanned coronary revascularizations and heart failure). Estimated treatment effects were consistent for the primary endpoint with non-adjudicated and adjudicated events (HR 0.88, 95% confidence interval (CI): 0.78\u20130.98 and HR 0.85, 95% CI: 0.75\u20130.98, respectively), with no apparent differences across event types except for heart failure and revascularization.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Registry data provided effect estimates of beta-blockers comparable to adjudicated data. However, adjudication substantially reduced the number of cardiovascular endpoint events and event-specific misclassification appeared, particularly during the first months after the index event.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>BETAMI-DANBLOCK ClinicalTrials.gov numbers, NCT03646357 and NCT03778554<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ehjqcco\/qcag055","type":"journal-article","created":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T11:38:02Z","timestamp":1774957082000},"page":"903-911","source":"Crossref","is-referenced-by-count":1,"title":["Validating national registry data for randomized trials: comparison of registry-derived cardiovascular events with and without adjudication in the BETAMI-DANBLOCK trial"],"prefix":"10.1093","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7667-7080","authenticated-orcid":false,"given":"Therese Lucia Friis","family":"Holmager","sequence":"first","affiliation":[{"name":"Department of Cardiology, Copenhagen University Hospital\u2014Bispebjerg and Frederiksberg , Nordre Fasanvej 57, Copenhagen 2000 Frederiksberg ,","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9608-7902","authenticated-orcid":false,"given":"Anna Meta Dyrvig","family":"Kristensen","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Copenhagen University Hospital\u2014Bispebjerg and Frederiksberg , Nordre Fasanvej 57, Copenhagen 2000 Frederiksberg ,","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4535-5043","authenticated-orcid":false,"given":"Morten Wang","family":"Fagerland","sequence":"additional","affiliation":[{"name":"Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital , 0372 Oslo ,","place":["Norway"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1513-8793","authenticated-orcid":false,"given":"Dan","family":"Atar","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Oslo University Hospital Ullevaal , 0450 Oslo ,","place":["Norway"]},{"name":"Institute of Clinical Medicine, Faculty of Medicine, University of Oslo , 0372 Oslo ,","place":["Norway"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8760-8323","authenticated-orcid":false,"given":"Michael","family":"Hecht Olsen","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine, University of Copenhagen , 2200 Copenhagen ,","place":["Denmark"]},{"name":"Department of Internal Medicine 1, Holb\u00e6k Hospital , 4300 Holb\u00e6k ,","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arnhild","family":"Bakken","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Oslo University Hospital Ullevaal , 0450 Oslo ,","place":["Norway"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6141-2162","authenticated-orcid":false,"given":"John","family":"Munkhaugen","sequence":"additional","affiliation":[{"name":"Department of Medicine, Drammen Hospital, Vestre Viken Hospital Trust , 3004 Drammen ,","place":["Norway"]},{"name":"Department of Behavioural Medicine, Faculty of Medicine, University of Oslo , 0372 Oslo ,","place":["Norway"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva","family":"Prescott","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Copenhagen University Hospital\u2014Bispebjerg and Frederiksberg , Nordre Fasanvej 57, Copenhagen 2000 Frederiksberg ,","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,4,4]]},"reference":[{"key":"2026091606023386400_qcag055-B1","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1016\/j.jclinepi.2016.08.003","article-title":"Registry-based randomized controlled trials- what are the advantages, challenges, and areas for future research?","volume":"80","author":"Li","year":"2016","journal-title":"J Clin Epidemiol"},{"key":"2026091606023386400_qcag055-B2","doi-asserted-by":"crossref","first-page":"375","DOI":"10.1186\/s13063-024-08209-3","article-title":"Registry-based randomised controlled trials: conduct, advantages and challenges\u2014a systematic review","volume":"25","author":"Shiely","year":"2024","journal-title":"Trials"},{"key":"2026091606023386400_qcag055-B3","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1080\/03009734.2018.1516706","article-title":"When do we need clinical endpoint adjudication in clinical trials?","volume":"124","author":"Held","year":"2019","journal-title":"Ups J Med Sci"},{"key":"2026091606023386400_qcag055-B4","doi-asserted-by":"crossref","first-page":"e012832","DOI":"10.1136\/bmjopen-2016-012832","article-title":"Positive predictive value of cardiovascular diagnoses in the Danish national patient registry: a validation study","volume":"6","author":"Sundb\u00f8ll","year":"2016","journal-title":"BMJ Open"},{"key":"2026091606023386400_qcag055-B5","doi-asserted-by":"crossref","first-page":"E007963","DOI":"10.1161\/CIRCOUTCOMES.121.007963","article-title":"Characteristics and quality of national cardiac registries: a systematic review","volume":"14","author":"Dawson","year":"2021","journal-title":"Circ Cardiovasc Qual Outcomes"},{"key":"2026091606023386400_qcag055-B6","doi-asserted-by":"crossref","first-page":"675","DOI":"10.2147\/CLEP.S321293","article-title":"Validating acute myocardial infarction diagnoses in national health registers for use as endpoint in research: the Troms\u00f8 study","volume":"13","author":"Varmdal","year":"2021","journal-title":"Clin Epidemiol"},{"key":"2026091606023386400_qcag055-B7","doi-asserted-by":"crossref","first-page":"1042","DOI":"10.1177\/14034948211021191","article-title":"Data from national health registers as endpoints for the Troms\u00f8 study: correctness and completeness of stroke diagnoses","volume":"51","author":"Varmdal","year":"2023","journal-title":"Scand J Public Health"},{"key":"2026091606023386400_qcag055-B8","doi-asserted-by":"crossref","first-page":"197","DOI":"10.1016\/j.ahj.2013.12.032","article-title":"Agreement between public register and adjudication committee outcome in a cardiovascular randomized clinical trial","volume":"168","author":"Kj\u00f8ller","year":"2014","journal-title":"Am Heart J"},{"key":"2026091606023386400_qcag055-B9","doi-asserted-by":"crossref","first-page":"735","DOI":"10.1097\/EDE.0000000000000688","article-title":"Validity of cardiovascular disease event ascertainment using linkage to UK hospital records","volume":"28","author":"Kivim\u00e4ki","year":"2017","journal-title":"Epidemiology"},{"key":"2026091606023386400_qcag055-B10","doi-asserted-by":"crossref","first-page":"237","DOI":"10.1007\/s10654-009-9335-x","article-title":"Validity of coronary heart diseases and heart failure based on hospital discharge and mortality data in The Netherlands using the cardiovascular registry Maastricht cohort study","volume":"24","author":"Merry","year":"2009","journal-title":"Eur J Epidemiol"},{"key":"2026091606023386400_qcag055-B11","first-page":"1","article-title":"The validity of the diagnosis of heart failure (I50.0-I50.9) in the Danish national patient register","volume":"65","author":"Delekta","year":"2018","journal-title":"Dan Med J"},{"key":"2026091606023386400_qcag055-B12","first-page":"2394","article-title":"Validity of heart failure diagnoses, treatments, and readmissions in the Danish national patient registry","volume":"9","author":"Bonnesen","year":"2024","journal-title":"Int J Popul Data Sci"},{"key":"2026091606023386400_qcag055-B13","doi-asserted-by":"crossref","first-page":"120","DOI":"10.1016\/j.ahj.2022.03.005","article-title":"Independence of clinical events committees: a consensus statement from clinical research organizations","volume":"248","author":"Spitzer","year":"2022","journal-title":"Am Heart J"},{"key":"2026091606023386400_qcag055-B14","doi-asserted-by":"crossref","first-page":"1901","DOI":"10.1056\/NEJMoa2505985","article-title":"Beta-blockers after myocardial infarction in patients without heart failure","volume":"393","author":"Munkhaugen","year":"2025","journal-title":"N Engl J Med"},{"key":"2026091606023386400_qcag055-B15","doi-asserted-by":"crossref","first-page":"175","DOI":"10.1093\/ehjcvp\/pvad093","article-title":"The Danish-Norwegian randomized trial on beta-blocker therapy after myocardial infarction: design, rationale, and baseline characteristics","volume":"10","author":"Kristensen","year":"2024","journal-title":"Eur Heart J Cardiovasc Pharmacother"},{"key":"2026091606023386400_qcag055-B16","doi-asserted-by":"crossref","first-page":"30","DOI":"10.1177\/1403494811401482","article-title":"The Danish national patient register","volume":"39","author":"Lynge","year":"2011","journal-title":"Scand J Public Health"},{"key":"2026091606023386400_qcag055-B17","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1177\/1403494819859737","article-title":"The Norwegian Patient Registry and the Norwegian Registry for Primary Health Care: research potential of two nationwide health-care registries","volume":"48","author":"Bakken","year":"2020","journal-title":"Scand J Public Health"},{"key":"2026091606023386400_qcag055-B18","doi-asserted-by":"crossref","first-page":"961","DOI":"10.1161\/CIRCULATIONAHA.117.033502","article-title":"2017 cardiovascular and stroke endpoint definitions for clinical trials","volume":"137","author":"Hicks","year":"2018","journal-title":"Circulation"},{"key":"2026091606023386400_qcag055-B19","doi-asserted-by":"crossref","first-page":"e618","DOI":"10.1161\/CIR.0000000000000617","article-title":"Fourth universal definition of myocardial infarction (2018)","volume":"138","author":"Thygesen","year":"2018","journal-title":"Circulation"},{"key":"2026091606023386400_qcag055-B20","doi-asserted-by":"crossref","first-page":"128","DOI":"10.1056\/NEJMoa2112299","article-title":"Fractional flow reserve\u2013guided PCI as compared with coronary bypass surgery","volume":"386","author":"Fearon","year":"2022","journal-title":"N Engl J Med"},{"key":"2026091606023386400_qcag055-B21","doi-asserted-by":"crossref","first-page":"1845","DOI":"10.1056\/NEJMoa2104508","article-title":"Angiotensin receptor\u2013neprilysin inhibition in acute myocardial infarction","volume":"385","author":"Pfeffer","year":"2021","journal-title":"N Engl J Med"},{"key":"2026091606023386400_qcag055-B22","first-page":"e210","article-title":"2017 AHA\/ACC\/HRS guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: executive summary","volume":"138","author":"Al-Khatib","year":"2018","journal-title":"Circulation"},{"key":"2026091606023386400_qcag055-B23","doi-asserted-by":"crossref","first-page":"1200","DOI":"10.1001\/jama.2019.1696","article-title":"In-hospital cardiac arrest: a review","volume":"321","author":"Andersen","year":"2019","journal-title":"JAMA\u2014J Am Med Assoc"},{"key":"2026091606023386400_qcag055-B24","doi-asserted-by":"crossref","first-page":"124","DOI":"10.1016\/j.ahj.2018.04.011","article-title":"International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: rationale and design","volume":"201","author":"Maron","year":"2018","journal-title":"Am Heart J"},{"key":"2026091606023386400_qcag055-B25","doi-asserted-by":"crossref","first-page":"22","DOI":"10.1177\/1403494810387965","article-title":"The Danish Civil Registration System","volume":"39","author":"Pedersen","year":"2011","journal-title":"Scand J Public Health"},{"key":"2026091606023386400_qcag055-B26","doi-asserted-by":"crossref","first-page":"1132","DOI":"10.1056\/NEJMoa1706443","article-title":"Bivalirudin versus heparin monotherapy in myocardial infarction","volume":"377","author":"Erlinge","year":"2017","journal-title":"N Engl J Med"},{"key":"2026091606023386400_qcag055-B27","doi-asserted-by":"crossref","first-page":"1240","DOI":"10.1056\/NEJMoa1706222","article-title":"Oxygen therapy in suspected acute myocardial infarction","volume":"377","author":"Hofmann","year":"2017","journal-title":"N Engl J Med"},{"key":"2026091606023386400_qcag055-B28","doi-asserted-by":"crossref","first-page":"149","DOI":"10.1016\/j.ahj.2025.04.028","article-title":"Data quality assessment in the SWEDEHEART registry: insights from serial audits on completeness and accuracy","volume":"288","author":"Leosdottir","year":"2025","journal-title":"Am Heart J"},{"key":"2026091606023386400_qcag055-B29","doi-asserted-by":"crossref","first-page":"113","DOI":"10.3109\/08037059209077502","article-title":"Prospective randomized open blinded End-point (PROBE) study. A novel design for intervention trials","volume":"1","author":"Hansson","year":"1992","journal-title":"Blood Press"},{"key":"2026091606023386400_qcag055-B30","doi-asserted-by":"crossref","first-page":"14","DOI":"10.1177\/1403494817702336","article-title":"Nordic registry-based cohort studies: possibilities and pitfalls when combining Nordic registry data","volume":"45","author":"Maret-Ouda","year":"2017","journal-title":"Scand J Public Health"}],"container-title":["European Heart Journal - Quality of Care and Clinical Outcomes"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ehjqcco\/advance-article-pdf\/doi\/10.1093\/ehjqcco\/qcag055\/67786834\/qcag055.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ehjqcco\/article-pdf\/12\/6\/903\/67786834\/qcag055.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ehjqcco\/article-pdf\/12\/6\/903\/67786834\/qcag055.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T10:02:40Z","timestamp":1789552960000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ehjqcco\/article\/12\/6\/903\/8586802"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,4]]},"references-count":30,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2026,4,4]]},"published-print":{"date-parts":[[2026,9,16]]}},"URL":"https:\/\/doi.org\/10.1093\/ehjqcco\/qcag055","relation":{},"ISSN":["2058-5225","2058-1742"],"issn-type":[{"value":"2058-5225","type":"print"},{"value":"2058-1742","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,9]]},"published":{"date-parts":[[2026,4,4]]}}}