Registry-based randomized clinical trials—a new clinical trial paradigm

ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction—Executive Summary

Antman, E. M., Anbe, D. T., Armstrong, P. W., Bates, E., Green, L. A., Hand, M. M., Hochman, J. S., Krumholz, H. M., Kushner, F. G., Lamas, G. A., et al. (2004) · Circulation · doi:10.1161/01.cir.0000134791.68010.fa · Cited by 8,345 · see citing works

Prasugrel versus clopidogrel in patients with acute coronary syndromes

Wiviott, S. D., Braunwald, E., McCabe, C. H., Montalescot, G., Ruzyllo, W., Gottlieb, S., Neumann, F.-J., Ardissino, D., De Servi, S., Murphy, S. A., et al. (2007) · New England Journal of Medicine · doi:10.1056/nejmoa0706482 · Cited by 6,790 · see citing works

2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction

O’Gara, P. T., Kushner, F. G., Ascheim, D. D., Casey, D. E., Chung, M. K., de Lemos, J. A., Ettinger, S. M., Fang, J. C.-T., Fesmire, F. M., Franklin, B. A., et al. (2012) · Circulation · doi:10.1161/cir.0b013e3182742cf6 · Cited by 4,763 · see citing works

A comparison of observational studies and randomized, controlled trials.

Benson, K., & Hartz, A. J. (2000) · New England Journal of Medicine · doi:10.1056/nejm200006223422506 · Cited by 2,347 · see citing works

Long-Term Outcomes with Drug-Eluting Stents versus Bare-Metal Stents in Sweden

Lagerqvist, B., James, S. K., Stenestrand, U., Lindbäck, J., Nilsson, T., & Wallentin, L. C. (2007) · New England Journal of Medicine · doi:10.1056/nejmoa067722 · Cited by 1,197 · see citing works

Thrombus Aspiration during ST-Segment Elevation Myocardial Infarction

Fröbert, O., Lagerqvist, B., Olivecrona, G. K., Ömerovic, E., Guðnason, Þ., Mæng, M., Aasa, M., Angerås, O., Calais, F., Danielewicz, M., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1308789 · Cited by 1,152 · see citing works

Scientific evidence underlying the ACC/AHA clinical practice guidelines.

Tricoci, P. (2009) · JAMA · doi:10.1001/jama.2009.205 · Cited by 908 · see citing works

The Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART)

Jernberg, T., Attebring, M. F., Hambræus, K., Ivert, T., James, S. K., Jeppsson, A., Lagerqvist, B., Lindahl, B., Stenestrand, U., & Wallentin, L. C. (2010) · Heart · doi:10.1136/hrt.2010.198804 · Cited by 773 · see citing works

Cardiovascular, bleeding, and mortality risks in elderly medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation

Graham, D. J., Reichman, M. E., Wernecke, M., Zhang, R., Southworth, M. R., Levenson, M., Sheu, T.-C., Mott, K., Goulding, M. R., Houstoun, M., et al. (2015) · Circulation · doi:10.1161/circulationaha.114.012061 · Cited by 644 · see citing works

The Patient-Centered Outcomes Research Institute

Newhouse, R. P., Barksdale, D. J., & Miller, J. A. (2014) · Nursing Research · doi:10.1097/nnr.0000000000000070 · Cited by 608 · see citing works

The Randomized Registry Trial — The Next Disruptive Technology in Clinical Research?

Lauer, M. S., & D'Agostino, R. B. (2013) · New England Journal of Medicine · doi:10.1056/nejmp1310102 · Cited by 497 · see citing works

A comparison of observational studies and randomized, controlled trials

Benson, K., & Hartz, A. J. (2000) · American Journal of Ophthalmology · doi:10.1016/s0002-9394(00)00754-6 · Cited by 456 · see citing works

Outcomes 1 Year after Thrombus Aspiration for Myocardial Infarction

Lagerqvist, B., Fröbert, O., Olivecrona, G. K., Guðnason, Þ., Mæng, M., Alström, P., Andersson, J. S. O., Calais, F., Carlsson, J., Collste, O., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1405707 · Cited by 393 · see citing works

Long-Term Safety and Efficacy of Drug-Eluting versus Bare-Metal Stents in Sweden

James, S. K., Stenestrand, U., Lindbäck, J., CARLSSON, J., Scherstén, F., Nilsson, T., Wallentin, L. C., & Lagerqvist, B. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0809902 · Cited by 237 · see citing works

Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia (TASTE trial). A multicenter, prospective, randomized, controlled clinical registry trial based on the Swedish angiography and angioplasty registry (SCAAR) platform. Study design and rationale

Fröbert, O., Lagerqvist, B., Guðnason, Þ., Thuesen, L., Svensson, R., Olivecrona, G. K., & James, S. K. (2010) · American Heart Journal · doi:10.1016/j.ahj.2010.08.040 · Cited by 187 · see citing works

Specific barriers to the conduct of randomized trials

Duley, L., Antman, K. H., Arena, J. P., Avezum, Á., Blumenthal, M., Bosch, J., Chrolavicius, S., Li, T., Ôunpuu, S., Pérez, A. C., et al. (2008) · Clinical Trials · doi:10.1177/1740774507087704 · Cited by 177 · see citing works

The NCDR CathPCI Registry: a US national perspective on care and outcomes for percutaneous coronary intervention

Moussa, I. D., Hermann, A., Messenger, J. C., DEHMER, G. J., Weaver, W. D., Rumsfeld, J. S., & Masoudi, F. A. (2013) · Heart · doi:10.1136/heartjnl-2012-303379 · Cited by 130 · see citing works

Randomized Clinical Trials — Removing Unnecessary Obstacles

Reith, C. A., Landray, M., Devereaux, P. J., Bosch, J., Granger, C. B., Baigent, C., Califf, R. M., Collins, R., & Yusuf, S. (2013) · New England Journal of Medicine · doi:10.1056/nejmsb1300760 · Cited by 123 · see citing works

Comparison of two drug-eluting balloons: a report from the SCAAR registry

Bondesson, P., Lagerqvist, B., James, S. K., Olivecrona, G. K., Venetsanos, D., & Harnek, J. (2012) · EuroIntervention · doi:10.4244/eijv8i4a70 · Cited by 90 · see citing works

The imperative of overcoming barriers to the conduct of large, simple trials.

Eapen, Z. J., Lauer, M. S., & Temple, R. J. (2014) · JAMA · doi:10.1001/jama.2014.1030 · Cited by 89 · see citing works

Embedding a randomized clinical trial into an ongoing registry infrastructure: Unique opportunities for efficiency in design of the Study of Access site For Enhancement of Percutaneous Coronary Intervention for Women (SAFE-PCI for Women)

Hess, C. N., Rao, S. V., Kong, D. F., Aberle, L. H., Anstrom, K. J., Gibson, C. M., Gilchrist, I. C., Jacobs, A. K., Jolly, S. S., Mehran, R., et al. (2013) · American Heart Journal · doi:10.1016/j.ahj.2013.06.013 · Cited by 81 · see citing works

DETermination of the role of OXygen in suspected Acute Myocardial Infarction trial

Hofmann, R., James, S. K., Svensson, L. A., Witt, N., Frick, M., Lindahl, B., Östlund, O., Ekelund, U. E. G., Erlinge, D., Herlitz, J. D., et al. (2013) · American Heart Journal · doi:10.1016/j.ahj.2013.09.022 · Cited by 70 · see citing works

2012 ESC STEMI guidelines and reperfusion therapy

Steg, P. G., James, S. K., & Gersh, B. J. (2013) · Heart · doi:10.1136/heartjnl-2013-304498 · Cited by 56 · see citing works

The 2011 outcome from the Swedish Health Care Registry on Heart Disease (SWEDEHEART)

Harnek, J., Nilsson, J., Friberg, Ö., James, S. K., Lagerqvist, B., Hambræus, K., Cider, Å., Svennberg, L., Attebring, M. F., Held, C., et al. (2013) · Scandinavian Cardiovascular Journal · doi:10.3109/14017431.2013.780389 · Cited by 41 · see citing works

Cardiovascular registries: a novel platform for randomised clinical trials

James, S. K., Fröbert, O., & Lagerqvist, B. (2012) · Heart · doi:10.1136/heartjnl-2012-301727 · Cited by 35 · see citing works

Outcome of Drug-Eluting Versus Bare-Metal Stenting Used According to On- and Off-Label Criteria

CARLSSON, J., James, S. K., Lindbäck, J., Scherstén, F., Nilsson, T., Stenestrand, U., & Lagerqvist, B. (2009) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2008.09.067 · Cited by 32 · see citing works

Event detection using population-based health care databases in randomized clinical trials: a novel research tool in interventional cardiology

Thuesen, L., Jensen, L. O., Tilsted, H. H., Mæng, M., Terkelsen, C. J., Thayssen, P., Ravkilde, J., Christiansen, E. H., Bøtker, H. E., Madsen, M., et al. (2013) · Clinical Epidemiology · doi:10.2147/clep.s44651 · Cited by 26 · see citing works

When It Comes to Trials, Do We Get What We Pay For?

Devereaux, P. J., & Yusuf, S. (2013) · New England Journal of Medicine · doi:10.1056/nejme1310554 · Cited by 13 · see citing works

2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA)

Mancia, G., Kreutz, R., Brunström, M., Burnier, M., Grassi, G., Januszewicz, A., Muiesan, M. L., Tsioufis, K., Agabiti-Rosei, E., Algharably, E. A. E., et al. (2023) · Journal of Hypertension · doi:10.1097/hjh.0000000000003480 · Cited by 3,473 · see citing works

Registries for Evaluating Patient Outcomes: A User’s Guide

(2020) · doi:10.23970/ahrqepcregistries4 · Cited by 968 · see citing works

Electronic health records to facilitate clinical research

Cowie, M. R., Blomster, J. I., Curtis, L. H., Duclaux, S., Ford, I., Fritz, F., Goldman, S., Janmohamed, S., Kreuzer, J., Leenay, M., et al. (2017) · Clinical Research in Cardiology · doi:10.1007/s00392-016-1025-6 · Cited by 651 · see citing works

The Magic of Randomization versus the Myth of Real-World Evidence

Collins, R., Bowman, L. J., Landray, M., & Peto, R. (2020) · New England Journal of Medicine · doi:10.1056/nejmsb1901642 · Cited by 481 · see citing works

Neural Natural Language Processing for unstructured data in electronic health records: A review

Li, I., Pan, J. N., Goldwasser, J., Verma, N., Wong, W. P., Nuzumlalı, M. Y., Rosand, B., Li, Y., Zhang, M. M., Chang, D., et al. (2022) · Computer Science Review · doi:10.1016/j.cosrev.2022.100511 · Cited by 262 · see citing works

Registry-based randomized controlled trials- what are the advantages, challenges, and areas for future research?

Li, G., Sajobi, T. T., Menon, B. K., Korngut, L. W., Lowerison, M. W., James, M. T., Wilton, S. B., Williamson, T. S., Gill, S. J., Drogos, L. L., et al. (2016) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2016.08.003 · Cited by 247 · see citing works

Levels of Evidence Supporting American College of Cardiology/American Heart Association and European Society of Cardiology Guidelines, 2008-2018

Fanaroff, A. C., Califf, R. M., Windecker, S., Smith, S. C., & Lopes, R. D. (2019) · JAMA · doi:10.1001/jama.2019.1122 · Cited by 228 · see citing works

Recommendations for Improving the Quality of Rare Disease Registries

Kodra, Y., Weinbach, J., de la Paz, M. P., Coi, A., Lemonnier, S. L., van Enckevort, D., Roos, M., Jacobsen, A., Ronald Cornet, A., Ahmed, S. F., et al. (2018) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph15081644 · Cited by 190 · see citing works

Early Versus Delayed Non–Vitamin K Antagonist Oral Anticoagulant Therapy After Acute Ischemic Stroke in Atrial Fibrillation (TIMING): A Registry-Based Randomized Controlled Noninferiority Study

Oldgren, J., Åsberg, S., Hijazi, Z., Wester, P. O., Bertilsson, M., Norrving, B. G., & Collaborators, F. T. N. T. (2022) · Circulation · doi:10.1161/circulationaha.122.060666 · Cited by 183 · see citing works

Considerations for Integration of Perioperative Electronic Health Records Across Institutions for Research and Quality Improvement: The Approach Taken by the Multicenter Perioperative Outcomes Group

Colquhoun, D. A., Shanks, A. M., Kapeles, S. R., Shah, N. J., Saager, L., Vaughn, M. T., Buehler, K., Burns, M. L., Tremper, K. K., Freundlich, R. E., et al. (2020) · Anesthesia & Analgesia · doi:10.1213/ane.0000000000004489 · Cited by 148 · see citing works

GLP-1 receptor agonists and SGLT2 inhibitors for older people with type 2 diabetes: a systematic review and meta-analysis

Karagiannis, T., Tsapas, A., Athanasiadou, E., Avgerinos, I., Liakos, A., Matthews, D. R., & Bekiari, E. (2021) · Diabetes Research and Clinical Practice · doi:10.1016/j.diabres.2021.108737 · Cited by 146 · see citing works

The Swedish Heart Failure Registry: a living, ongoing quality assurance and research in heart failure

Savarese, G., Vaško, P., Jonsson, Å., Edner, M., Dahlström, U., & Lund, L. H. (2018) · Upsala Journal of Medical Sciences · doi:10.1080/03009734.2018.1490831 · Cited by 146 · see citing works

Toward Establishing Core Outcome Domains For Trials in Kidney Transplantation

Tong, A., Gill, J., Budde, K., Marson, L., Reese, P. P., Rosenbloom, D., Rostaing, L. P. E., Wong, G., Josephson, M. A., Pruett, T. L., et al. (2017) · Transplantation · doi:10.1097/tp.0000000000001774 · Cited by 139 · see citing works

CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration

Kwakkenbos, L., Imran, M., McCall, S. J., McCord, K. A., Fröbert, O., Hemkens, L. G., Zwarenstein, M., Relton, C., Rice, D. B., Langan, S., et al. (2021) · BMJ · doi:10.1136/bmj.n857 · Cited by 136 · see citing works

Continuing versus suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: Impact on adverse outcomes in hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)--The BRACE CORONA Trial

Lópes, R. D., Macedo, A. V. S., Silva, P. G. M. D. B. E., Moll-Bernardes, R. J., Feldman, A., Arruda, G. D. S., de Souza, A. S., de Albuquerque, D. C., Barbosa, L. M., Santos, M. F., et al. (2020) · American Heart Journal · doi:10.1016/j.ahj.2020.05.002 · Cited by 137 · see citing works

Comparison of hernia registries: the CORE project

Kyle-Leinhase, I., KÖckerling, F., Jørgensen, L. N., Montgomery, A. K., Gillion, J. ‐., Rodriguez, J. A. P., Hope, W. W., & Muysoms, F. E. (2018) · Hernia · doi:10.1007/s10029-017-1724-6 · Cited by 124 · see citing works

R-IDEAL: A Framework for Systematic Clinical Evaluation of Technical Innovations in Radiation Oncology

Verkooijen, H. M., Kerkmeijer, L. G. W., Fuller, C. D., Huddart, R. A., Finn, C. F., Verheij, M., Mook, S., Sahgal, A., Hall, E., & Schultz, C. (2017) · Frontiers in Oncology · doi:10.3389/fonc.2017.00059 · Cited by 121 · see citing works

The value of pragmatic and observational studies in health care and public health

Barnish, M. S., & Turner, S. (2017) · Pragmatic and Observational Research · doi:10.2147/por.s137701 · Cited by 118 · see citing works

Lifespan Perspective on Congenital Heart Disease Research

Diller, G., Arvanitaki, A., Opotowsky, A. R., Jenkins, K. J., Moons, P., Kempny, A., Tandon, A. A., Redington, A. N., Khairy, P., Mital, S. R., et al. (2021) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2021.03.012 · Cited by 114 · see citing works

Treatment Strategies for Cardiomyopathy in Children: A Scientific Statement From the American Heart Association

Bogle, C., Colan, S. D., Miyamoto, S. D., Choudhry, S., Hernandez, N. B., Brickler, M. M., Feingold, B., Lal, A. K., Lee, T. M., Canter, C. E., et al. (2023) · Circulation · doi:10.1161/cir.0000000000001151 · Cited by 111 · see citing works

Using digital technologies in clinical trials: Current and future applications

Rosa, C., Marsch, L. A., Winstanley, E. L., Brunner, M., & Campbell, A. N. C. (2020) · Contemporary Clinical Trials · doi:10.1016/j.cct.2020.106219 · Cited by 106 · see citing works

Perspective: Limiting Dependence on Nonrandomized Studies and Improving Randomized Trials in Human Nutrition Research: Why and How

Trepanowski, J. F., & Ioannidis, J. P. A. (2018) · Advances in Nutrition · doi:10.1093/advances/nmy014 · Cited by 106 · see citing works

Report of the Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) Consensus Workshop on Establishing a Core Outcome Measure for Hemodialysis Vascular Access

Viecelli, A. K., Tong, A., O’Lone, E., Ju, A., Hanson, C. S., Sautenet, B., Craig, J. C., Manns, B., Howell, M., Chemla, E. S., et al. (2018) · American Journal of Kidney Diseases · doi:10.1053/j.ajkd.2017.12.003 · Cited by 102 · see citing works

Registry-based randomized controlled trials merged the strength of randomized controlled trails and observational studies and give rise to more pragmatic trials

Mathes, T., Bühn, S., Prengel, P., & Pieper, D. (2017) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.09.017 · Cited by 96 · see citing works

Dementia registries around the globe and their applications: A systematic review

Krysinska, K. E., Sachdev, P. S., Breitner, J. C. S., Kivipelto, M., Kukull, W. A., & Brodaty, H. (2017) · Alzheimer s & Dementia · doi:10.1016/j.jalz.2017.04.005 · Cited by 94 · see citing works

Defining key design elements of registry-based randomised controlled trials: a scoping review

Karanatsios, B., Prang, K.-H., Verbunt, E., Yeung, J. M. C., Kelaher, M., & Gibbs, P. (2020) · Trials · doi:10.1186/s13063-020-04459-z · Cited by 92 · see citing works

Eculizumab Use for Kidney Transplantation in Patients With a Diagnosis of Atypical Hemolytic Uremic Syndrome

Siedlecki, A. M., Isbel, N. M., Walle, J. V., Eggleston, J. J., Cohen, D. J., Licht, C. P. B., Frémeaux‐Bacchi, V., Ariceta, G., Ardissino, G., Fakhouri, F., et al. (2018) · Kidney International Reports · doi:10.1016/j.ekir.2018.11.010 · Cited by 90 · see citing works

Registry-Based Pragmatic Trials in Heart Failure: Current Experience and Future Directions

Lund, L. H., Oldgren, J., & James, S. K. (2017) · Current Heart Failure Reports · doi:10.1007/s11897-017-0325-0 · Cited by 89 · see citing works

Generating comparative evidence on new drugs and devices after approval

Cipriani, A., Ioannidis, J. P. A., Rothwell, P. M., Glasziou, P., Li, T., Hernandez, A. F., Tomlinson, A., Simes, R. J., & Naci, H. (2020) · The Lancet · doi:10.1016/s0140-6736(19)33177-0 · Cited by 87 · see citing works

The Changing Landscape of Randomized Clinical Trials in Cardiovascular Disease

Jones, W. S., Roe, M. T., Antman, E. M., Pletcher, M. J., Harrington, R. A., Rothman, R. L., Oetgen, W. J., Rao, S. V., Krucoff, M. W., Curtis, L. H., et al. (2016) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2016.07.781 · Cited by 86 · see citing works

Using real-world data to monitor and improve quality of care in coronary artery disease: results from the Netherlands Heart Registration

Timmermans, M. J. C., Houterman, S., Daeter, E. J., Danse, P. W., Li, W. W. L., Lipšic, E., Roefs, M. M., & van Veghel, D. (2022) · Netherlands Heart Journal · doi:10.1007/s12471-022-01672-0 · Cited by 86 · see citing works

Technology-Enabled Clinical Trials

Marquis‐Gravel, G., Roe, M. T., Turakhia, M. P., Boden, W. E., Temple, R., Sharma, A., Hirshberg, B., Slater, P., Craft, N. A., Stockbridge, N., et al. (2019) · Circulation · doi:10.1161/circulationaha.119.040798 · Cited by 85 · see citing works

Value Creation Through Artificial Intelligence and Cardiovascular Imaging: A Scientific Statement From the American Heart Association

Hanneman, K., Playford, D., Dey, D., van Assen, M., Mastrodicasa, D., Cook, T. S., Gichoya, J. W., Williamson, E. E., Rubin, G. D., & on behalf of the American Heart Association Council on Cardiovascular Radiology and Intervention; and Council on Lifelong Congenital Heart Disease and Heart Health in the Young (2024) · Circulation · doi:10.1161/cir.0000000000001202 · Cited by 72 · see citing works

A Pragmatic Randomized Feasibility Trial of Influenza Vaccines

Johansen, N. D., Modin, D., Nealon, J., Samson, S., Salamand, C., Loiacono, M. M., Larsen, C. S., Jensen, A. M. R., Landler, N. E., Claggett, B. L., et al. (2023) · NEJM Evidence · doi:10.1056/evidoa2200206 · Cited by 70 · see citing works

Burst Spinal Cord Stimulation: A Clinical Review

Kirketeig, T., Schultheis, B. C., Zuidema, X., Hunter, C., & Deer, T. R. (2019) · Pain Medicine · doi:10.1093/pm/pnz003 · Cited by 63 · see citing works

Biologics registers in RA: methodological aspects, current role and future applications

Nikiphorou, E., Buch, M. H., & Hyrich, K. L. (2017) · Nature Reviews Rheumatology · doi:10.1038/nrrheum.2017.81 · Cited by 64 · see citing works

The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry‐Based Randomized Trial: The EFFORT Trial

Heyland, D. K., Patel, J. J., Bear, D. E., Sacks, G. S., Nixdorf, H., Dolan, J., Aloupis, M., Licastro, K., Jovanović, V., Rice, T. W., et al. (2018) · Journal of Parenteral and Enteral Nutrition · doi:10.1002/jpen.1449 · Cited by 63 · see citing works

Natural Language Processing for Mimicking Clinical Trial Recruitment in Critical Care: A Semi-Automated Simulation Based on the LeoPARDS Trial

Tissot, H. C., Shah, A. D., Brealey, D., Harris, S., Agbakoba, R., Folarin, A., Romao, L., Roguski, L., Dobson, R., & Asselbergs, F. W. (2020) · IEEE Journal of Biomedical and Health Informatics · doi:10.1109/jbhi.2020.2977925 · Cited by 61 · see citing works

Artificial intelligence in spine surgery

Benzakour, A., Altsitzioglou, P., D, J.-M. L. M., Ahmad, A. A., Mavrogenis, A. F., & Benzakour, T. (2022) · International Orthopaedics · doi:10.1007/s00264-022-05517-8 · Cited by 59 · see citing works

Magnetic resonance imaging (MRI) guided proton therapy: A review of the clinical challenges, potential benefits and pathway to implementation

Pham, T. T., Whelan, B., Oborn, B. M., Delaney, G. P., Vinod, S. K., Brighi, C., Barton, M. B., & Keall, P. (2022) · Radiotherapy and Oncology · doi:10.1016/j.radonc.2022.02.031 · Cited by 56 · see citing works

Leveraging electronic health records for clinical research

Raman, S. R., Curtis, L. H., Temple, R., Andersson, T., Ezekowitz, J. A., Ford, I., James, S. K., Marsolo, K. A., Mirhaji, P., Rocca, M., et al. (2018) · American Heart Journal · doi:10.1016/j.ahj.2018.04.015 · Cited by 51 · see citing works

Thrombus aspiration in acute myocardial infarction

Mahmoud, K. D., & Zijlstra, F. (2016) · Nature Reviews Cardiology · doi:10.1038/nrcardio.2016.38 · Cited by 50 · see citing works

Long-Term Oxygen Therapy 24 vs 15 h/day and Mortality in Chronic Obstructive Pulmonary Disease

Ahmadi, Z., Sundh, J., Hermansson, A. B., & Ekström, M. P. (2016) · PLoS ONE · doi:10.1371/journal.pone.0163293 · Cited by 50 · see citing works

Registries: Big data, bigger problems?

Rubinger, L., Ekhtiari, S., Gazendam, A., & Bhandari, M. (2021) · Injury · doi:10.1016/j.injury.2021.12.016 · Cited by 48 · see citing works

Role of Big Data in Cardiovascular Research

Weintraub, W. S. (2019) · Journal of the American Heart Association · doi:10.1161/jaha.119.012791 · Cited by 48 · see citing works

Acute pancreatitis patient registry to examine novel therapies in clinical experience (APPRENTICE): an international, multicenter consortium for the study of acute pancreatic

Papachristou, G. I. (2016) · Annals of Gastroenterology · doi:10.20524/aog.2016.0109 · Cited by 48 · see citing works

The what, when and how of orthopaedic registers: an introduction into register-based research

Varnum, C., Pedersen, A. B., Gundtoft, P. H., & Overgaard, S. (2019) · EFORT Open Reviews · doi:10.1302/2058-5241.4.180097 · Cited by 46 · see citing works

The pancreatic surgery registry (StuDoQ|Pancreas) of the German Society for General and Visceral Surgery (DGAV) – presentation and systematic quality evaluation

Wellner, U., Klinger, C., Lehmann, K., Buhr, H., Neugebauer, E., & Keck, T. (2017) · Trials · doi:10.1186/s13063-017-1911-x · Cited by 45 · see citing works

Lifestyle modifications for non-alcohol related fatty liver disease: a network meta-analysis

Buzzetti, E., Linden, A. H., Best, L. M., Madden, A. M., Roberts, D. A., Chase, T. J. G., Freeman, S. C., Cooper, N. J., Sutton, A. J., Fritche, D., et al. (2018) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd013156 · Cited by 48 · see citing works

Exploring new uses for existing drugs: innovative mechanisms to fund independent clinical research

Verbaanderd, C., Rooman, I., & Huys, I. (2021) · Trials · doi:10.1186/s13063-021-05273-x · Cited by 45 · see citing works

Twenty Years of Get With The Guidelines-Stroke: Celebrating Past Successes, Lessons Learned, and Future Challenges

Reeves, M. J., Fonarow, G. C., Smith, E. E., Sheth, K. N., Messe, S. R., & Schwamm, L. H. (2024) · Stroke · doi:10.1161/strokeaha.124.046527 · Cited by 44 · see citing works

Prevention of heart failure after acute myocardial infarction

Udell, J. A., Bahit, M. C., Campbell, P., Butler, J., Chopra, V., Bayés‐Genís, A., Bozkurt, B., Petrie, M. C., & Vaduganathan, M. (2025) · The Lancet · doi:10.1016/s0140-6736(25)01394-7 · Cited by 46 · see citing works

Ticagrelor and Aspirin or Aspirin Alone after Coronary Surgery for Acute Coronary Syndrome

Jeppsson, A., James, S. K., Møller, C. H., Malm, C. J., Dalén, M., Vánky, F. B., Modrau, I. S., Andersen, K. K., Anttila, V., Atroshchenko, G. V., et al. (2025) · New England Journal of Medicine · doi:10.1056/nejmoa2508026 · Cited by 44 · see citing works

Analysis of a Systematic Review About Blue Light–Filtering Intraocular Lenses for Retinal Protection

Downie, L. E., Wormald, R., Evans, J. R., Virgili, G., Keller, P. R., Lawrenson, J. G., & Li, T. (2019) · JAMA Ophthalmology · doi:10.1001/jamaophthalmol.2019.0019 · Cited by 44 · see citing works

Creating a culture of health: evolving healthcare systems and patient engagement

Lindblad, S., Ernestam, S., Citters, A. D. V., Lind, C., Morgan, T., & Nelson, E. C. (2016) · QJM · doi:10.1093/qjmed/hcw188 · Cited by 43 · see citing works

Re‐inventing the randomized controlled trial in medical oncology: The registry‐based trial

Foroughi, S., Wong, H., Gately, L., Lee, M., Simons, K., Tie, J., Burgess, A. W., & Gibbs, P. (2018) · Asia-Pacific Journal of Clinical Oncology · doi:10.1111/ajco.12992 · Cited by 43 · see citing works

Registry randomised trials: a methodological perspective

Doherty, D. A., Tong, S. Y. C., Reilly, J. R., Shrapnel, J., McDonald, S. P., Ahern, S., Harris, I. A., Tam, C. S., Brennan, A., Hodgson, C. L., et al. (2023) · BMJ Open · doi:10.1136/bmjopen-2022-068057 · Cited by 42 · see citing works

Taking Systems Medicine to Heart

Trachana, K., Bargaje, R., Glusman, G., Price, N. D., Huang, S., & Hood, L. E. (2018) · Circulation Research · doi:10.1161/circresaha.117.310999 · Cited by 41 · see citing works

Understanding The Strengths And Weaknesses Of Public Reporting Of Surgeon-Specific Outcome Data

Burns, E. M., Pettengell, C., Athanasiou, T., & Darzi, A. W. (2016) · Health Affairs · doi:10.1377/hlthaff.2015.0788 · Cited by 41 · see citing works

David G. Sherman Lecture Award: 15-Year Experience of the Nationwide Multicenter Stroke Registry in Korea

Bae, H., Kim, J. Y., Kang, J., Kim, B. J., Han, M., Choi, K., Kim, J., Park, M., Cho, K., Kim, B.-K., et al. (2022) · Stroke · doi:10.1161/strokeaha.122.039212 · Cited by 40 · see citing works

Long-Term Oxygen Therapy for 24 or 15 Hours per Day in Severe Hypoxemia

Ekström, M. P., Andersson, A., Papadopoulos, S., Kipper, T., Pedersen, B., Kricka, O., Sobrino, P., Runold, M., Palm, A., Blomberg, A., et al. (2024) · New England Journal of Medicine · doi:10.1056/nejmoa2402638 · Cited by 39 · see citing works

Low risk pragmatic trials do not always require participants’ informed consent

Dal‐Ré, R., Avendaño, C., Bloechl‐Daum, B., de Boer, A., Eriksson, S., Fuhr, U., Holm, S., James, S. K., Mentz, R. J., Perucca, E., et al. (2019) · BMJ · doi:10.1136/bmj.l1092 · Cited by 39 · see citing works

Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data

Kwakkenbos, L., Juszczak, E., Hemkens, L. G., Sampson, M., Fröbert, O., Relton, C., Gale, C., Zwarenstein, M., Langan, S., Moher, D., et al. (2018) · Research Integrity and Peer Review · doi:10.1186/s41073-018-0053-3 · Cited by 36 · see citing works

Study protocol: The DUALITY trial—a register-based, randomized controlled trial to investigate dual mobility cups in hip fracture patients

Wolf, O., Mukka, S., Notini, M., Möller, M., Hailer, N. P., & the DUALITY GROUP (2020) · Acta Orthopaedica · doi:10.1080/17453674.2020.1780059 · Cited by 38 · see citing works

Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative

Dember, L. M., Archdeacon, P., Krishnan, M., Lacson, E. K., Jr., Ling, S. M., Roy‐Chaudhury, P., Smith, K. A., & Flessner, M. F. (2016) · Journal of the American Society of Nephrology · doi:10.1681/asn.2016030340 · Cited by 37 · see citing works

Impact of hip arthroplasty registers on orthopaedic practice and perspectives for the future

Varnum, C., Pedersen, A. B., Rolfson, O., Rogmark, C., Furnes, O. N., Hallan, G., Mäkelä, K. T., de Steiger, R. N., Porter, M., & Overgaard, S. (2019) · EFORT Open Reviews · doi:10.1302/2058-5241.4.180091 · Cited by 37 · see citing works

The effect of multimedia-based nursing visit on preoperative anxiety and vital signs in patients undergoing lumbar disc herniation surgery: A randomised clinical trial

Zarei, B., Valiee, S., Nouri, B., Khosravi, F., & Fathi, M. (2018) · Journal of Perioperative Practice · doi:10.1177/1750458917742045 · Cited by 36 · see citing works

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

Fraser, A. G., Nelissen, R. G. H. H., Kjærsgaard‐Andersen, P., Szymański, P., Melvin, T., Piscoi, P., CORE-MD Investigators, Fraser, A. G., Szymański, P., Gale, C. P., et al. (2021) · European Heart Journal - Quality of Care and Clinical Outcomes · doi:10.1093/ehjqcco/qcab059 · Cited by 36 · see citing works

Long-term health outcomes for patients with obstructive sleep apnea: placing the Agency for Healthcare Research and Quality report in context—a multisociety commentary

Patil, S. P., Billings, M. E., Bourjeily, G. R., Collop, N. A., Gottlieb, D. J., Johnson, K. G., Kimoff, R. J., & Pack, A. I. (2023) · Journal of Clinical Sleep Medicine · doi:10.5664/jcsm.10832 · Cited by 39 · see citing works

Addressing the Unmet Needs of Measuring Vascular Ageing in Clinical Practice—European COoperation in Science and Technology Action VascAgeNet

Climie, R. E., Mayer, C. C., Bruno, R. M., & Hametner, B. (2020) · Artery Research · doi:10.2991/artres.k.200328.001 · Cited by 35 · see citing works

Comparing Effect Estimates in Randomized Trials and Observational Studies From the Same Population: An Application to Percutaneous Coronary Intervention

Matthews, A., Szummer, K. E., Dahabreh, I. J., Lindahl, B., Erlinge, D., Feychting, M., Jernberg, T., Berglund, A., & Hernán, M. Á. (2021) · Journal of the American Heart Association · doi:10.1161/jaha.120.020357 · Cited by 33 · see citing works

Validation study: evaluation of the metrological quality of French hospital data for perinatal algorithms

Goueslard, K., Cottenet, J., Benzenine, É., Tubert‐Bitter, P., & Quantin, C. (2020) · BMJ Open · doi:10.1136/bmjopen-2019-035218 · Cited by 32 · see citing works

Design and rationale of the NetherLands registry of invasive Coronary vasomotor Function Testing (NL-CFT)

Crooijmans, C., Jansen, T. P. J., Konst, R. E., Woudstra, J., Appelman, Y., den Ruijter, H. M., Onland‐Moret, N. C., Meeder, J. G., de Vos, A. M. J., Paradies, V., et al. (2023) · International Journal of Cardiology · doi:10.1016/j.ijcard.2023.02.043 · Cited by 31 · see citing works

The use of real-world evidence for evaluating anti–vascular endothelial growth factor treatment of neovascular age-related macular degeneration

Talks, J. S., Daïen, V., Finger, R. P., Eldem, B. M., Sakamoto, T., Cardillo, J. A., Mitchell, P., Wong, T. Y., & Korobelnik, J. (2019) · Survey of Ophthalmology · doi:10.1016/j.survophthal.2019.02.008 · Cited by 30 · see citing works

Prediction of 3-year all-cause and cardiovascular cause mortality in a prospective percutaneous coronary intervention registry: Machine learning model outperforms conventional clinical risk scores

Călburean, P., Grebenișan, P., Nistor, I.-A., Pál, K., Vacariu, V., Drincal, R.-K., Țepeș, O., Bârlea, I., Şuş, I., Somkereki, C., et al. (2022) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2022.03.028 · Cited by 31 · see citing works

Registry-based randomised clinical trial: efficient evaluation of generic pharmacotherapies in the contemporary era

Yndigegn, T., Hofmann, R., Jernberg, T., & Gale, C. P. (2018) · Heart · doi:10.1136/heartjnl-2017-312322 · Cited by 31 · see citing works

The present and future of cardiac arrest care: international experts reach out to caregivers and healthcare authorities

Nolan, J. P., Berg, R. A., Callaway, C. W., Morrison, L. J., Nadkarni, V., Perkins, G. D., Sandroni, C., Skrifvars, M. B., Soar, J., Sunde, K., et al. (2018) · Intensive Care Medicine · doi:10.1007/s00134-018-5230-9 · Cited by 30 · see citing works

STAIR X

Liebeskind, D. S., Derdeyn, C. P., Wechsler, L. R., Albers, G. W., Ankerud, E. P., Boltze, J., Broderick, J. P., Campbell, B. C. V., Elkind, M. S. V., En’Wezoh, D. C., et al. (2018) · Stroke · doi:10.1161/strokeaha.118.021424 · Cited by 30 · see citing works

Opportunities and barriers for pragmatic embedded trials: Triumphs and tribulations

Ramsberg, J., & Platt, R. G. (2017) · Learning Health Systems · doi:10.1002/lrh2.10044 · Cited by 28 · see citing works

Antibiotic-Loaded Bone Cement in Prevention of Periprosthetic Joint Infections in Primary Total Knee Arthroplasty: A Register-based Multicentre Randomised Controlled Non-inferiority Trial (ALBA trial)

Leta, T. H., Gjertsen, J., Dale, H., Hallan, G., Lygre, S. H. L., Fenstad, A. M., Dyrhovden, G. S., Westberg, M., Wik, T. S., Jakobsen, R. B., et al. (2021) · BMJ Open · doi:10.1136/bmjopen-2020-041096 · Cited by 29 · see citing works

Relationship between therapeutic effects on infarct size in acute myocardial infarction and therapeutic effects on 1-year outcomes: A patient-level analysis of randomized clinical trials

Selker, H. P., Udelson, J. E., Ruthazer, R., D’Agostino, R. B., Nichols, M., Ben‐Yehuda, O., Eitel, I., Granger, C. B., Jenkins, P., Maehara, A., et al. (2017) · American Heart Journal · doi:10.1016/j.ahj.2017.02.028 · Cited by 29 · see citing works

Epidemiology of donors and recipients: lessons from the SCANDAT database

Edgren, G., & Hjalgrim, H. (2017) · Transfusion Medicine · doi:10.1111/tme.12487 · Cited by 28 · see citing works

Two-year outcomes of left bundle branch area pacing versus traditional right ventricular pacing in middle-aged adults: a registry-based trial

Bertini, M., Canovi, L., Vitali, F., Marcantoni, L., Pastore, G., Volpicelli, M., Munciguerra, O., Biffi, M., Ziacchi, M., Rossi, L. C., et al. (2025) · EP Europace · doi:10.1093/europace/euaf181 · Cited by 28 · see citing works

Stroke prevention in atrial fibrillation: re-defining ‘real-world data’ within the broader data universe

Fanaroff, A. C., Steffel, J., Alexander, J. H., Lip, G. Y. H., Califf, R. M., & Lópes, R. D. (2018) · European Heart Journal · doi:10.1093/eurheartj/ehy236 · Cited by 27 · see citing works

Time to Shock the System: Moving Beyond the Current Paradigm for Primary Prevention Implantable Cardioverter‐Defibrillator Use

Merchant, F. M., Levy, W. C., & Kramer, D. B. (2020) · Journal of the American Heart Association · doi:10.1161/jaha.119.015139 · Cited by 27 · see citing works

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE–MD (Coordinating Research and Evidence for Medical Devices)

Fraser, A. G., Nelissen, R. G. H. H., Kjærsgaard‐Andersen, P., Szymański, P., Melvin, T., Piscoi, P., & On behalf of the CORE–MD Investigators (see Appendix) (2021) · EFORT Open Reviews · doi:10.1302/2058-5241.6.210081 · Cited by 27 · see citing works

Architecture of the Japan Ischemic Heart Disease Multimodal Prospective Data Acquisition for Precision Treatment (J-IMPACT) System

Matoba, T., Kohro, T., Fujita, H., Nakayama, M., Kiyosue, A., Miyamoto, Y., Nishimura, K., Hashimoto, H., Antoku, Y., Nakashima, N., et al. (2019) · International Heart Journal · doi:10.1536/ihj.18-113 · Cited by 26 · see citing works

Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative

Mikita, J. S., Mitchel, J. T., Gatto, N. M., Laschinger, J. C., Tcheng, J. E., Zeitler, E. P., Swern, A. S., Flick, E. D., Dowd, C., Lystig, T., et al. (2020) · Therapeutic Innovation & Regulatory Science · doi:10.1007/s43441-020-00185-5 · Cited by 26 · see citing works

Rationale and Design of the ISOLATION Study: A Multicenter Prospective Cohort Study Identifying Predictors for Successful Atrial Fibrillation Ablation in an Integrated Clinical Care and Research Pathway

Verhaert, D. V. M., Linz, D., Chaldoupi, S., Westra, S. W., den Uijl, D. W., Philippens, S., Kerperien, M., Habibi, Z., Vorstermans, B. J. G. H., ter Bekke, R. M. A., et al. (2022) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2022.879139 · Cited by 26 · see citing works

AcT Trial: Protocol for a Pragmatic Registry‐Linked Randomized Clinical Trial

Sajobi, T. T., Singh, N., Almekhlafi, M., Buck, B. H., Ademola, A., Coutts, S. B., Deschaintre, Y., Khosravani, H., Appireddy, R., Moreau, F., et al. (2022) · Stroke Vascular and Interventional Neurology · doi:10.1161/svin.122.000447 · Cited by 27 · see citing works

Assessing the Nationwide Impact of a Registry-Based Randomized Clinical Trial on Cardiovascular Practice

Buccheri, S., Sarno, G., Fröbert, O., Guðnason, Þ., Lagerqvist, B., Lindholm, D. P., Mæng, M., Olivecrona, G. K., & James, S. K. (2019) · Circulation Cardiovascular Interventions · doi:10.1161/circinterventions.118.007381 · Cited by 26 · see citing works

REgistry-based randomized controlled trial of treatment and Duration and mortality in long-term OXygen therapy (REDOX) study protocol

Sundh, J., Hermansson, A. B., Ahmadi, Z., Blomberg, A., Janson, C., Currow, D. C., McDonald, C. F., McCaffrey, N., & Ekström, M. P. (2019) · BMC Pulmonary Medicine · doi:10.1186/s12890-019-0809-7 · Cited by 25 · see citing works

Informed consent in pragmatic trials: results from a survey of trials published 2014–2019

Zhang, J. Z., Nicholls, S. G., Carroll, K. A., Nix, H. P., Goldstein, C. E., Hey, S. P., Brehaut, J., McLean, P. C., Weijer, C., Fergusson, D. A., et al. (2021) · Journal of Medical Ethics · doi:10.1136/medethics-2021-107765 · Cited by 25 · see citing works

New Approaches to Conducting Randomized Controlled Trials

Fanaroff, A. C., Califf, R. M., & Lópes, R. D. (2020) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2019.11.043 · Cited by 25 · see citing works

Registry-based randomised controlled trials: conduct, advantages and challenges—a systematic review

Shiely, F., O Shea, N., Murphy, E., & Eustace, J. (2024) · Trials · doi:10.1186/s13063-024-08209-3 · Cited by 24 · see citing works

Feasibility of randomizing Danish citizens aged 65–79 years to high-dose quadrivalent influenza vaccine vs. standard-dose quadrivalent influenza vaccine in a pragmatic registry-based setting: rationale and design of the DANFLU-1 Trial

Johansen, N. D., Modin, D., Nealon, J., Samson, S., Salamand, C., Larsen, C. S., Claggett, B. L., Solomon, S. D., Landray, M., Gislason, G., et al. (2022) · Pilot and Feasibility Studies · doi:10.1186/s40814-022-01044-w · Cited by 24 · see citing works

Leveraging Artificial Intelligence and Synthetic Data Derivatives for Spine Surgery Research

Greenberg, J. K., Landman, J. M., Kelly, M. P., Pennicooke, B. H., Molina, C. A., Foraker, R. E., & Ray, W. Z. (2022) · Global Spine Journal · doi:10.1177/21925682221085535 · Cited by 24 · see citing works

Assessing the Eligibility Criteria in Phase III Randomized Controlled Trials of Drug Therapy in Heart Failure With Preserved Ejection Fraction: The Critical Play-Off Between a “Pure” Patient Phenotype and the Generalizability of Trial Findings

Patel, H. C., Hayward, C., Dungu, J. N., Papadopoulou, S. A., Saidmeerasah, A., Ray, R., Mario, C. D., Shanmugam, N., Cowie, M., & Anderson, L. J. (2017) · Journal of Cardiac Failure · doi:10.1016/j.cardfail.2017.04.006 · Cited by 24 · see citing works

Data standards for acute coronary syndrome and percutaneous coronary intervention: the European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart)

Batra, G., Aktaa, S., Wallentin, L. C., Maggioni, A. P., Ludman, P., Erlinge, D., Casadei, B., & Gale, C. P. (2022) · European Heart Journal · doi:10.1093/eurheartj/ehac133 · Cited by 23 · see citing works

No-touch vein grafts in coronary artery bypass surgery: a registry-based randomized clinical trial

Thelin, S., Modrau, I. S., Duvernoy, O., Dalén, M., Dreifaldt, M., Ericsson, A. B., Friberg, Ö., Holmgren, A., Nielsen, P. H., Hultkvist, H., et al. (2025) · European Heart Journal · doi:10.1093/eurheartj/ehaf018 · Cited by 22 · see citing works

Registry-based randomised controlled trials: conduct, advantages and challenges—a systematic review

Shiely, F., O Shea, N., Murphy, E., & Eustace, J. (2024) · Trials · doi:10.1186/s13063-024-08209-3 · Cited by 24 · see citing works

Registry-Based Randomized Controlled Trials: Conduct, Advantages and Challenges – A Systematic Review.Preprint

Shea, N. O., Eustace, J. A., Murphy, E., & Shiely, F. (2022) · Research Square · doi:10.21203/rs.3.rs-1485391/v1 · Cited by 1 · see citing works

Defining key design elements of registry-based randomised controlled trials: a scoping review

Karanatsios, B., Prang, K.-H., Verbunt, E., Yeung, J. M. C., Kelaher, M., & Gibbs, P. (2020) · Trials · doi:10.1186/s13063-020-04459-z · Cited by 92 · see citing works

Registry randomized controlled trials: the future of surgical trials?

Arafat, Y., Wei, M. Y.-K., Karanatsios, B., Mendis, S. R., Gibbs, P., & Yeung, J. M. C. (2023) · ANZ Journal of Surgery · doi:10.1111/ans.18458 · Cited by 1 · see citing works

Registry-based Randomized Controlled Trials (RRCTs): characteristics, potential use options and potential limitations

Urban, L., Pieper, D., Haller, N., Munschek, S., & Mathes, T. (2024) · German Medical Science (German Research Foundation) · doi:10.3205/24ebm005