Evidence map›Paper›PMID 25781411›Full record

ReviewNature reviews. Cardiology2015

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

Stefan James, Sunil V Rao, Christopher B Granger

6 registry-linked trialsAbstract readReview
PubMed Publisher
In one paragraph

Review in Nature reviews. Cardiology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 143 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
143citing papers in PubMed, 6 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01787110 phase3completednot on this map

DETermination of the Role of OXygen in Suspected Acute Myocardial Infarction (DETO2X-AMI) Based on the SWEDEHEART Registry

TypeinterventionalSponsorKarolinska InstitutetRan2013 to 2016Enrolled6,629ConditionsAcute Coronary Syndrome, Non-ST Elevation (NSTEMI) Myocardial Infarction, Acute ST Segment Elevation Myocardial Infarction, Angina, UnstableArmsOxygen
NCT04067297 naactive not recruitingnot on this mapstarted 2019, after this paper: background citation

Using Big Data to Conduct Innovative Cardiovascular Clinical Trials: The Community Heart Outcomes Improvement and Cholesterol Education Study (CHOICES)

TypeinterventionalSponsorInstitute for Clinical Evaluative SciencesRan2019 to 2027Enrolled500,000ConditionsCardiovascular Diseases, Cardiovascular Risk Factor, DyslipidemiasArmsLipid management toolbox
NCT04242966 phase3withdrawnnot on this mapstarted 2020, after this paper: background citation

The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-based Randomized Trial: The EFFORT Ultrasound a Sub-study

TypeinterventionalSponsorClinical Evaluation Research Unit at Kingston General HospitalRan2020 to 2022Enrolled0ConditionsCritical Illness, MalnutritionArmsUsual Care, Higher Protein/Amino Acid Group, Ultrasound measure
NCT04633603 enrolling by invitationnot on this mapstarted 2020, after this paper: background citation

LázBarát™ (FeverFriend™) Projekt: Attitude Toward Fever and Its Change in the Healthcare System

Typeobservational_patient_registrySponsorUniversity of PecsRan2020 to 2028Enrolled10,000ConditionsFever, Anxiety, Help-Seeking Behavior, Virus DiseasesArmsFeverFriend mobile application
NCT05003180 naactive not recruitingnot on this mapstarted 2021, after this paper: background citation

SunBurst (StUdy oN Burst Fractures) - a National, Multicenter, Register-based, Randomized Controlled Trial on Thoracolumbar Burst Fractures

TypeinterventionalSponsorUppsala UniversityRan2021 to 2036Enrolled202ConditionsThoracolumbar Burst FractureArmsSurgical stabilization
NCT07081737 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

The Future of Pain Management: Can Person-centred and Precision AI-Based Decision Support Enhance Interdisciplinary Rehabilitation for Chronic Pain?

TypeinterventionalSponsorBjorn AngRan2026 to 2029Enrolled400ConditionsPain, Chronic, Chronic Pain, Widespread, Pain ManagementArmsInterdisciplinary treatment (IDT) + Clinical Decision Support System (CDSS), Interdisciplinary treatment (IDT)
3 · Its place in the literature

Who cites it

143 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  6. Dementia registries around the globe and their applications: A systematic review.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2017
    Pooled it
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  8. Two-year outcomes of left bundle branch area pacing versus traditional right ventricular pacing in middle-aged adults: a registry-based trial.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025
    Trial
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83 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Stefan JamesUppsala Clinical Research Center, Uppsala University Hospital, Dag Hammarskjölds väg 14B, 75237 Uppsala, Sweden.
Sunil V RaoThe Duke Clinical Research Institute, Duke University Medical Center, 2301 Erwin Road, Durham, NC 27710, USA.
Christopher B GrangerThe Duke Clinical Research Institute, Duke University Medical Center, 2301 Erwin Road, Durham, NC 27710, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

CardiologyRandomized Controlled Trials as TopicRegistriesResearch DesignHumans

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.