Registry-based randomised clinical trials: a remedy for evidence-based diabetes care?

Article Orthopedics

Study protocol: The SunBurst trial-a register-based, randomized controlled trial on thoracolumbar burst fractures

Simon Blixt et al.

Summary: This study aims to compare the outcomes of surgical and non-surgical treatment for thoracolumbar burst fractures. The primary outcome measure is the Oswestry Disability Index (ODI) at 1 year after injury.

ACTA ORTHOPAEDICA (2022)

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Editorial Material Endocrinology & Metabolism

Summary of Revisions: Standards of Medical Care in Diabetes-2022

DIABETES CARE (2022)

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Article Endocrinology & Metabolism

Cardiovascular risk profiles: A cross-sectional study evaluating the generalizability of the glucagon-like peptide-1 receptor agonist cardiovascular outcome trials REWIND, LEADER and SUSTAIN-6 to the real-world type 2 diabetes population in the United Kingdom

Joanne Webb et al.

Summary: The study found that the cardiovascular criteria related to the REWIND trial were more representative of the real-world population of patients with type 2 diabetes in the UK compared to LEADER and SUSTAIN-6, with a higher proportion of patients meeting the CV and combined CV/core criteria.

DIABETES OBESITY & METABOLISM (2022)

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Article Medicine, General & Internal

Cardiovascular Outcomes in Patients Initiating First-Line Treatment of Type 2 Diabetes With Sodium-Glucose Cotransporter-2 Inhibitors Versus Metformin A Cohort Study

Hojin Shin et al.

Summary: This study aimed to evaluate cardiovascular outcomes of first-line SGLT-2i versus metformin treatment in patients with type 2 diabetes. The results showed that there was no significant difference in the risk for myocardial infarction, stroke, and mortality between patients receiving SGLT-2i and those receiving metformin. However, the risk for heart failure and mortality was lower in patients receiving SGLT-2i. The safety profiles were similar between the two treatment groups, except for a higher risk of genital infections in patients receiving SGLT-2i.

ANNALS OF INTERNAL MEDICINE (2022)

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Article Endocrinology & Metabolism

A registry-based randomised trial comparing an SGLT2 inhibitor and metformin as standard treatment of early stage type 2 diabetes (SMARTEST): Rationale, design and protocol

Johan Sundstrom et al.

Summary: The study aims to compare the effectiveness of the SGLT2 inhibitor dapagliflozin and metformin as first-line medication for T2D, investigating their ability to prevent complications in early stage T2D patients.

JOURNAL OF DIABETES AND ITS COMPLICATIONS (2021)

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Review Ethics

Digital tools in the informed consent process: a systematic review

Francesco Gesualdo et al.

Summary: Through a systematic review, it was found that digital technologies for informed consent did not negatively affect any outcomes, and overall, multimedia tools seem to be more desirable. Multimedia tools had a greater impact than videos alone. The presence of a researcher in research IC processes may enhance the efficacy of different outcomes.

BMC MEDICAL ETHICS (2021)

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Article Cardiac & Cardiovascular Systems

Cardiorenal and other diabetes related outcomes with SGLT-2 inhibitors compared to GLP-1 receptor agonists in type 2 diabetes: nationwide observational study

Moa Lugner et al.

Summary: This observational study indicated that treatment with GLP-1RA and SGLT-2i result in very similar cardiorenal outcomes. In the short term, treatment with GLP-1RA seem to be associated with lower risks of stroke and peripheral artery disease, whereas SGLT-2i seem to be nominally associated with lower risk of heart failure and total mortality.

CARDIOVASCULAR DIABETOLOGY (2021)

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Article Cardiac & Cardiovascular Systems

Transposition of cardiovascular outcome trial effects to the real-world population of patients with type 2 diabetes

V Sciannameo et al.

Summary: Transposing CVOT results to the population of T2D patients in real-world clinical practice showed that the cardiovascular protective effects of glucose-lowering medications tested in CVOTs can be transferred.

CARDIOVASCULAR DIABETOLOGY (2021)

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Article Medicine, General & Internal

Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease

W. S. Jones et al.

Summary: In a pragmatic trial involving patients with established cardiovascular disease, no significant differences were found in cardiovascular events or major bleeding between patients assigned to daily 81 mg and those assigned to 325 mg of aspirin.

NEW ENGLAND JOURNAL OF MEDICINE (2021)

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Article Endocrinology & Metabolism

Comparative effectiveness and safety of sodium-glucose cotransporter-2 inhibitors versus metformin in patients with type 2 diabetes: An observational study using data from routine care

Michael Fralick et al.

Summary: In treatment-naive patients with type 2 diabetes, newly prescribed SGLT2 inhibitors showed a slightly lower rate of cardiovascular events compared to metformin, but had higher risks of genital infections and diabetic ketoacidosis. Larger cohort studies and long-term clinical trials are needed to fully assess the risk-benefit profile of SGLT2 inhibitors as first-line therapy for adults with type 2 diabetes mellitus.

DIABETES OBESITY & METABOLISM (2021)

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Article Endocrinology & Metabolism

The efficacy and safety of novel classes of glucose-lowering drugs for cardiovascular outcomes: a network meta-analysis of randomised clinical trials

Donna Shu-Han Lin et al.

Summary: SGLT2i and GLP-1RA are superior to DPP-4i in terms of cardiovascular and renal outcomes. GLP-1RA is the only drug class that reduces the risk of stroke. SGLT2i is superior in reducing hospitalisation for heart failure (HHF) and renal outcomes.

DIABETOLOGIA (2021)

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Review Public, Environmental & Occupational Health

Nordic Health Registry-Based Research: A Review of Health Care Systems and Key Registries

Kristina Laugesen et al.

Summary: The Nordic countries provide unique opportunities for joint health registry-based research, but challenges such as cross-border data sharing hinder the full exploitation of their potential. Clear legal pathways and practical frameworks are needed for future collaboration.

CLINICAL EPIDEMIOLOGY (2021)

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Article Medicine, General & Internal

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)

Tesfaye H. Leta et al.

Summary: The current evidence on the efficacy of antibiotic-loaded bone cement in reducing the risk of periprosthetic joint infections after primary joint reconstruction is insufficient, leading to the design of a randomized controlled trial to investigate its effects.

BMJ OPEN (2021)

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Article Cardiac & Cardiovascular Systems

2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD

Francesco Cosentino et al.

EUROPEAN HEART JOURNAL (2020)

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Editorial Material Pharmacology & Pharmacy

Overcoming Regulatory Aversion to Novel Methods of Evidence Generation

Elodie Baumfeld Andre et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2020)

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Article Endocrinology & Metabolism

Enrolment criteria for diabetes cardiovascular outcome trials do not inform on generalizability to clinical practice: The case of glucagon-like peptide-1 receptor agonists

Veronica Sciannameo et al.

DIABETES OBESITY & METABOLISM (2020)

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Article Endocrinology & Metabolism

Sodium-glucose co-transporter-2 inhibitor cardiovascular outcome trials and generalizability to English primary care

W. Hinton et al.

DIABETIC MEDICINE (2020)

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Article Endocrinology & Metabolism

2019 update to: Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

John B. Buse et al.

DIABETOLOGIA (2020)

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Article Orthopedics

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

Olof Wolf et al.

ACTA ORTHOPAEDICA (2020)

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Article Endocrinology & Metabolism

Risk of cardiovascular events and death associated with initiation of SGLT2 inhibitors compared with DPP-4 inhibitors: an analysis from the CVD-REAL 2 multinational cohort study

Shun Kohsaka et al.

Lancet Diabetes & Endocrinology (2020)

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Review Medicine, General & Internal

The Lancet Commission on diabetes: using data to transform diabetes care and patient lives

Juliana C. N. Chan et al.

LANCET (2020)

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Review Medicine, General & Internal

Metformin monotherapy for adults with type 2 diabetes mellitus

Filip Gnesin et al.

COCHRANE DATABASE OF SYSTEMATIC REVIEWS (2020)

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Article Respiratory System

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

Josefin Sundh et al.

BMC PULMONARY MEDICINE (2019)

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Article Medicine, General & Internal

Pragmatic clinical trials in the context of regulation of medicines

Rolf Gedeborg et al.

UPSALA JOURNAL OF MEDICAL SCIENCES (2019)

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Review Cardiac & Cardiovascular Systems

Review of cardiovascular outcomes trials of sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists

Emily J. North et al.

CURRENT OPINION IN CARDIOLOGY (2019)

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Article Endocrinology & Metabolism

Dapagliflozin and cardiovascular mortality and disease outcomes in a population with type 2 diabetes similar to that of the DECLARE-TIMI 58 trial: A nationwide observational study

Anna Norhammar et al.

DIABETES OBESITY & METABOLISM (2019)

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Article Cardiac & Cardiovascular Systems

Prediction of individual life-years gained without cardiovascular events from lipid, blood pressure, glucose, and aspirin treatment based on data of more than 500 000 patients with Type 2 diabetes mellitus

Gijs F. N. Berkelmans et al.

EUROPEAN HEART JOURNAL (2019)

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Editorial Material Medicine, General & Internal

Real-world studies no substitute for RCTs in establishing efficacy

Hertzel C. Gerstein et al.

LANCET (2019)

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Article Medicine, Research & Experimental

Hysterectomy and opportunistic salpingectomy (HOPPSA): study protocol for a register-based randomized controlled trial

Annika Idahl et al.

TRIALS (2019)

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Article Endocrinology & Metabolism

Use of liraglutide and risk of major cardiovascular events: a register-based cohort study in Denmark and Sweden

Henrik Svanstrom et al.

LANCET DIABETES & ENDOCRINOLOGY (2019)

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Article Endocrinology & Metabolism

Effective translation of a type-2 diabetes primary prevention programme into routine primary care: The PreDE cluster randomised clinical trial

Alvaro Sanchez et al.

DIABETES RESEARCH AND CLINICAL PRACTICE (2018)

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Article Medicine, General & Internal

Sodium glucose cotransporter 2 inhibitors and risk of serious adverse events: nationwide register based cohort study

Peter Ueda et al.

BMJ-BRITISH MEDICAL JOURNAL (2018)

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Article Endocrinology & Metabolism

Different patterns of second-line treatment in type 2 diabetes after metformin monotherapy in Denmark, Finland, Norway and Sweden (D360 Nordic): A multinational observational study

Frederik Persson et al.

ENDOCRINOLOGY DIABETES & METABOLISM (2018)

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Article Public, Environmental & Occupational Health

The Swedish cause of death register

Hannah Louise Brooke et al.

EUROPEAN JOURNAL OF EPIDEMIOLOGY (2017)

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Article Cardiac & Cardiovascular Systems

Efficient design of clinical trials and epidemiological research: is it possible?

Michael S. Lauer et al.

NATURE REVIEWS CARDIOLOGY (2017)

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Article Medicine, General & Internal

Oxygen Therapy in Suspected Acute Myocardial Infarction

Robin Hofmann et al.

NEW ENGLAND JOURNAL OF MEDICINE (2017)

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Article Medicine, General & Internal

Bivalirudin versus Heparin Monotherapy in Myocardial Infarction

D. Erlinge et al.

NEW ENGLAND JOURNAL OF MEDICINE (2017)

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Article Medicine, General & Internal

Mortality and Cardiovascular Disease in Type 1 and Type 2 Diabetes

Aidin Rawshani et al.

NEW ENGLAND JOURNAL OF MEDICINE (2017)

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Article Medicine, General & Internal

Closure of mesenteric defects in laparoscopic gastric bypass: a multicentre, randomised, parallel, open-label trial

Erik Stenberg et al.

LANCET (2016)

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Review Medicine, General & Internal

Pragmatic Trials

Ian Ford et al.

NEW ENGLAND JOURNAL OF MEDICINE (2016)

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Article Endocrinology & Metabolism

Cardiovascular disease and mortality in patients with type 2 diabetes after bariatric surgery in Sweden: a nationwide, matched, observational cohort study

Bjorn Eliasson et al.

LANCET DIABETES & ENDOCRINOLOGY (2015)

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Article Medicine, General & Internal

Review of 103 Swedish Healthcare Quality Registries

L. Emilsson et al.

JOURNAL OF INTERNAL MEDICINE (2015)

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Article Cardiac & Cardiovascular Systems

A Registry-Based Randomized Trial Comparing Radial and Femoral Approaches in Women Undergoing Percutaneous Coronary Intervention The SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) Trial

Sunil V. Rao et al.

JACC-CARDIOVASCULAR INTERVENTIONS (2014)

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Article Medicine, General & Internal

Outcomes 1 Year after Thrombus Aspiration for Myocardial Infarction

Bo Lagerqvist et al.

NEW ENGLAND JOURNAL OF MEDICINE (2014)

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Article Endocrinology & Metabolism

Structured personal care of type 2 diabetes: a 19 year follow-up of the study Diabetes Care in General Practice (DCGP)

L. J. Hansen et al.

DIABETOLOGIA (2013)

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Review Public, Environmental & Occupational Health

External review and validation of the Swedish national inpatient register

Jonas F. Ludvigsson et al.

BMC PUBLIC HEALTH (2011)

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Article Endocrinology & Metabolism

Additive effects of glycaemia and dyslipidaemia on risk of cardiovascular diseases in type 2 diabetes: an observational study from the Swedish National Diabetes Register

S. Gudbjornsdottir et al.

DIABETOLOGIA (2011)

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Database Review Cardiac & Cardiovascular Systems

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

Tomas Jernberg et al.

HEART (2010)

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Article Endocrinology & Metabolism

Risk Prediction of Cardiovascular Disease in Type 2 Diabetes

Jan Cederholm et al.

DIABETES CARE (2008)

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Article Public, Environmental & Occupational Health

The new Swedish Prescribed Drug Register -: Opportunities for pharmacoepidemiological research and experience from the first six months

Bjorn Wettermark et al.

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY (2007)

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MA Hernán et al.

JOURNAL OF EPIDEMIOLOGY AND COMMUNITY HEALTH (2006)

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Article Endocrinology & Metabolism

The national diabetes register in Sweden -: An implementation of the St. Vincent declaration for quality improvement in diabetes care

S Gudbjörnsdottir et al.

DIABETES CARE (2003)

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Registry-based randomised clinical trials: a remedy for evidence-based diabetes care?

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