Cited by 331Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsAdvanced Causal Inference Techniques

The DOI matches its Crossref record; 28 of the 29 references it cites were found in a registry or an index.

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

James, Stefan, Rao, Sunil V., Granger, Christopher B.·2015·Nature Reviews Cardiology

DOI 10.1038/nrcardio.2015.33

Open this paper in CoChat — free account

Abstract

Randomized clinical trials provide the foundation of clinical evidence to guide physicians in their selection of treatment options. Importantly, randomization is the only reliable method to control for confounding factors when comparing treatment groups. However, randomized trials have limitations, including the increasingly prohibitive costs of conducting adequately powered studies. Local and national regulatory requirements, delays in approval, and unnecessary trial processes have led to increased costs and decreased efficiency. Another limitation is that clinical trials involve selected patients who are treated according to protocols that might not represent real-world practice. A possible solution is registry-based randomized clinical trials. By including a randomization module in a large inclusive clinical registry with unselected consecutive enrolment, the advantages of a prospective randomized trial can be combined with the strengths of a large-scale all-comers clinical registry. We believe that prospective registry-based randomized clinical trials are a powerful tool for conducting studies efficiently and cost-effectively.

Integrity signals

Registry

Crossref · 10.1038/nrcardio.2015.33

Cites

28 of 28 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

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 8,348
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
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 4,802
Self-citation
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
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
Self-citation
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
Self-citation
Scientific evidence underlying the ACC/AHA clinical practice guidelines.
Tricoci, P. (2009) · JAMA · doi:10.1001/jama.2009.205 · Cited by 908
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
Self-citation
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
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

Show all 29 references

Research works printed but not linked: 1

Thuesen, L. et al. Event detection using population-based health care databases in randomized clinical trials: a novel research tool in interventional cardiology. Clin. Epidemiol. 5, 357–361 (2013). · DOI

Sorted by citations

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
Registries for Evaluating Patient Outcomes: A User’s Guide
(2020) · doi:10.23970/ahrqepcregistries4 · Cited by 974
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
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 490
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 280
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
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
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
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 184
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
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
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
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 138
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 138
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., 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 138
Self-citation
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
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
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 126
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
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 115
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 115
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 107
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 103
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 92
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
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
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
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 91
Self-citation
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 89
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
Self-citation
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 94
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 86
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
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
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
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
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 62
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
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
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
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 56
Self-citation
Thrombus aspiration in acute myocardial infarction
Mahmoud, K. D., & Zijlstra, F. (2016) · Nature Reviews Cardiology · doi:10.1038/nrcardio.2016.38 · Cited by 50
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
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 53
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
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
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 49
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
Lifestyle modifications for nonalcohol-related fatty liver disease: a network meta-analysis
Buzzetti, E., Linden, A., Best, L. M., Madden, A. M., Roberts, D., Chase, T. J. G., Freeman, S. C., Cooper, N. J., Sutton, A. J., Fritche, D., et al. (2021) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd013156.pub2 · Cited by 46
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 49
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 45
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 48
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 46
Self-citation
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
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
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
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 46
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
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
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
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
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
Self-citation
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 37
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
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
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
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
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
Self-citation
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 42
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
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
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
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
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
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
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
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
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
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 29
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
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
Self-citation
Epidemiology of donors and recipients: lessons from the SCANDAT database
Edgren, G., & Hjalgrim, H. (2017) · Transfusion Medicine · doi:10.1111/tme.12487 · Cited by 29
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
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
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
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
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
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
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
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
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
Self-citation
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
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 27
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
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
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
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
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
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
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
Self-citation

Authors: James, S., Rao, S. V., & Granger, C. B.
Affiliations: Uppsala University Hospital (SE)
Duke Medical Center (US)
Corresponding author: James, Stefan
ORCID: James, Stefan
Rao, Sunil V.
Granger, Christopher B.
Venue: Nature Reviews Cardiology
Publisher: Springer Science and Business Media LLC
Published: 2015-03-17
Volume: 12
Issue: 5
Pages: 312-316
ISSN: 1759-5002 (ISSN-L)
1759-5010
DOI: 10.1038/nrcardio.2015.33
OpenAlex: W2056697517
Cited by: 331
References: 29
Citations by year: 2026: 12 · 2025: 29 · 2024: 33 · 2023: 34 · 2022: 32 · 2021: 46 · 2020: 33 · 2019: 36 · 2018: 35 · 2017: 20 · 2016: 17 · 2015: 3
FWCI: 4.19
Type: journal article
Language: en
Open access: closed
Licence: www.springer.com/tdm (tdm)
Locations: Nature Reviews Cardiology (publishedVersion)
PubMed (publishedVersion)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
Keywords: clinical registries, randomization, confounding adjustment, real-world practice, trial design limitations
MeSH terms: Cardiology, Humans, Registries, Research Design, Randomized Controlled Trials as Topic

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review

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

Abstract

Overview

Integrity signals

Verification

Claims the paper makes

Citations

Cites

Cited by

Related

Metadata

Record

About these checks