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Articles by Peter Jüni
Pulmonary Vein Isolation Using Pulsed Field Ablation With vs Without Posterior Wall Isolation in Patients With Symptomatic Persistent Atrial Fibrillation : The PIFPAF-PFA Randomized Clinical Trial
Pulmonary Vein Isolation Using Pulsed Field Ablation With vs Without Posterior Wall Isolation in Patients With Symptomatic Persistent Atrial Fibrillation: The PIFPAF-PFA Randomized Clinical Trial Supplement 1. Supplement 2. Statistical Analysis Plan Supplement 3. eAppendix 1. Inclusion and Exclusion Criteria eAppendix 2. Catheter Ablation Procedures eAppendix 3. Implantable Cardiac Monitor Programming eAppendix 4. Analysis of Atrial Arrhythmia Burden eTable 1.
Volume 46 Issue 20
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Cardiovascular Meta-analyses: Fool's Gold or Gold for Fools?
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Authors' reply to Kevin L Hunter. Re: Viscosupplementation for knee osteoarthritis: systematic review and meta-analysis
Dear Editor, As part of regulatory practice, investigators are typically required to provide a causal assessment for serious adverse events experienced by patients [1,2]. For completeness, we provided the verbatim assessments reported for each trial in our web appendix 24 [3].
Viscosupplementation for knee osteoarthritis: systematic review and meta-analysis
Principal findings This systematic review identified 169 trials on 21 163 randomised patients with knee osteoarthritis. The main analysis of the primary outcome was based on 24 large, placebo controlled trials that included 8997 randomised patients with knee osteoarthritis. We found that viscosupplementation was significantly associated with a small reduction in pain intensity compared with placebo, but the difference was less than the minimal clinically important between group difference.
Viscosupplementation for knee osteoarthritis: systematic review and meta-analysis
RESEARCH thebmj BMJ 9722 | doi: 10.1136/bmj-2022-069722 2022;378:e06 11 Research, University Hospital Basel, University of Basel, Switzerland; and Melodi Koşaner Kließ, Program in Health Technology Assessment, University of Glasgow, UK for their translations and data extractions of non-English trials. None of these people was compensated. Written permission has been obtained for all names mentioned. Contributors: TVP and PJ contributed equally to this work.
Viscosupplementation for knee osteoarthritis: systematic review and meta-analysis
Notes Contributors: TVP and PJ contributed equally to this work. BRdC and PJ conceived the idea for the review. BRdC, PJ, and TVP designed, undertook the literature search, and coordinated the study. AA, CAH, DX, LY, PB, and PS gave crucial intellectual input and provided critical revision for the initial protocol and database building. PB and PS contributed to the implementation of the study.
Abbreviated Antiplatelet Therapy in Patients at High Bleeding Risk With or Without Oral Anticoagulant Therapy After Coronary Stenting: An Open-Label, Randomized, Controlled Trial | Circulation
Abstract Background: The optimal duration of antiplatelet therapy (APT) in patients at high bleeding risk with or without oral anticoagulation (OAC) after coronary stenting remains unclear. Methods: In the investigator-initiated, randomized, open-label MASTER DAPT trial, 4579 patients at high bleeding risk were randomized after 1-month dual APT (DAPT) to abbreviated or nonabbreviated APT strategies. Randomization was stratified by concomitant OAC indication.
Single early palliative care intervention added to usual oncology care for patients with advanced cancer: A randomized controlled trial (SENS Trial)
1. Haun, MW, Estel, S, Rucker, G, et al. Early palliative care for adults with advanced cancer. Cochrane Database Syst Rev 2017; 6: CD011129. Google Scholar | Medline 2. Vanbutsele, G, Pardon, K, Van Belle, S, et al. Effect of early and systematic integration of palliative care in patients with advanced cancer: a randomised controlled trial. Lancet Oncol 2018; 19(3): 394–404. Google Scholar | Crossref | Medline 3. Ferrell, BR, Temel, JS, Temin, S, et al.
The Dangers of Ignoring History Lessons During a Pandemic
The global ravages of coronavirus disease 2019 (COVID-19) have directed attention to historical analyses of previous respiratory airborne pandemics, particularly the catastrophic influenza of 1918–1919 (1). Similarities in the epidemiologic characteristics of the 2 diseases left scientists, media, and the general public alike optimistically reaching back for century-spanning teachings.
Public Health Interventions, Epidemic Growth, and Regional Variation of the 1918 Influenza Pandemic Outbreak in a Swiss Canton and Its Greater Regions | Annals of Internal Medicine
The emergence of new viral epidemics is a major challenge for public health, as shown by the coronavirus disease 2019 (COVID-19) pandemic. In most Western countries, none of the global pandemics caused by respiratory viruses after 1920 have reached the severity of the 1889 and 1918 influenza pandemic outbreaks (1). Health policymakers may benefit from examining historical events to increase risk awareness and inform decision making during the COVID-19 pandemic ().
Biomechanical Footwear for Osteoarthritic Knee Pain-Reply
[Skip to Content Landing] Comment & Response October 6, 2020 JAMA. 2020;324(13):1351-1352. doi:10.1001/jama.2020.14825 Original Investigation Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis Stephan Reichenbach, MD, MSc; David T. Felson, MD, MPH; Cesar A. Hincapié, DC, PhD; Sarah Heldner, MD; Lukas Bütikofer, PhD; Armando Lenz, PhD; Bruno R. da Costa, MScPT, PhD; Harald M. Bonel, MD; Richard K. Jones, PhD; Gillian A.
Non-Technical Skills for Surgeons (NOTSS): Critical appraisal of its measurement properties
Highlights • Critical appraisal of NOTSS, a measurement tool for assessing non-technical skills of surgeons is presented. • Tool development included robust item generation, reduction, and scale assignment strategies. • The tool demonstrated strong internal consistency. • Inter-rater reliability increased with greater expertise and number of assessors. • Cross-sectional and longitudinal validity evidence for the tool to serve discriminatory and evaluative functions existed.
Time-varying intensity of mechanical ventilation and mortality in patients with acute respiratory failure: a registry-based, prospective cohort study
Summary Background Mortality in acute respiratory failure remains high despite the use of lung-protective ventilation. Recent studies have shown an association between baseline ventilation parameters (driving pressure or mechanical power) and outcomes for patients with acute respiratory distress syndrome. Strategies focused on limiting these parameters have been proposed to further improve outcomes.
Impact of climate and public health interventions on the COVID-19 pandemic: a prospective cohort study
Research Peter Jüni, Martina Rothenbühler, Pavlos Bobos, Kevin E. Thorpe, Bruno R. da Costa, David N. Fisman, Arthur S. Slutsky and Dionne Gesink CMAJ May 25, 2020 192 (21) E566-E573; DOI: https://doi.org/10.1503/cmaj.200920 Abstract BACKGROUND: It is unclear whether seasonal changes, school closures or other public health interventions will result in a slowdown of the current coronavirus disease 2019 (COVID-19) pandemic.
Biomechanical footwear system reduces pain in knee osteoarthritis
Patients with knee osteoarthritis experienced improved pain at 24 weeks after wearing specially designed footwear affixed with individually calibrated convex pods on the outsoles, according to data published in JAMA. “Biomechanics plays an important role in the development of osteoarthritis of the knee,” Peter Jüni, MD, of the University of Toronto and St. Michael’s Hospital, told Healio Rheumatology.
Impact of climate and public health interventions on the COVID-19 pandemic: A prospective cohort study
Original Articles Peter Jüni, Martina Rothenbühler, Pavlos Bobos, Kevin E. Thorpe, Bruno R. da Costa, David N. Fisman, Arthur S. Slutsky and Dionne Gesink CMAJ May 08, 2020 cmaj.200920; DOI: https://doi.org/10.1503/cmaj.200920 Abstract Background: It is unclear whether seasonal changes, school closures or other public health interventions will result in a slowdown of the current coronavirus disease 2019 (COVID-19) pandemic.
Dyspnoea in the GLOBAL LEADERS trial - Authors' reply
We thank David Martí and Marcelo Sanmartín for their interest in GLOBAL LEADERS. 1 Vranckx P Valgimigli M Juni P et al. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial. Lancet.
Biodegradable-polymer stents versus durable-polymer stents - Authors' reply
The BIOSCIENCE trial 1 Pilgrim T Heg D Roffi M et al. Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE): a randomised, single-blind, noninferiority trial. Lancet. 2014; 384: 2111-2122 was powered to assess non-inferiority for the primary outcome of target lesion failure at 12 months.
Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy
Summary Background Homoeopathy is widely used, but specific effects of homoeopathic remedies seem implausible. Bias in the conduct and reporting of trials is a possible explanation for positive findings of trials of both homoeopathy and conventional medicine. We analysed trials of homoeopathy and conventional medicine and estimated treatment effects in trials least likely to be affected by bias.
Pump, pipes, and filter: do SGLT2 inhibitors cover it all?
Concerns about the growing burden of diabetes are mounting.Temporal analyses suggest that cardiovascular risk in people with diabetes persists and, if anything, is widening for fatal outcomes.The need for interventions to prevent diabetes-related complications is clear.
Interpretation of results of pooled analysis of individual patient data
1 Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data. : of individual patient data from randomised trials comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with multivessel or left main disease.
Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-la
We hypothesised that ticagrelor, in combination with aspirin for 1 month, followed by ticagrelor alone, improves outcomes after percutaneous coronary intervention compared with standard antiplatelet regimens. GLOBAL LEADERS was a randomised, open-label superiority trial at 130 sites in 18 countries.
It Is Time to Initiate Another Breast Cancer Screening Trial
In 2009, the U.S. Preventive Services Task Force triggered a heated debate by recommending biennial mammography screening for women aged 50 to 74 years and individualized decisions about mammography for younger women based on context and personal preferences (1) . The debate calmed somewhat in 2012 when the Independent U.K. Panel on Breast Cancer Screening concluded that, although associated with some overdiagnosis, screening mammography reduced breast cancer mortality (2) .
Does access to clinical study reports from the European Medicines Agency reduce reporting biases? A systematic review and meta-analysis of randomized controlled trials on the effect of erythropoiesis-stimulating agents in cancer patients
Since 2010, the European Medicines Agency (EMA) has provided access to clinical study reports (CSRs). We requested CSRs for randomized controlled trials (RCTs) of erythropoiesis-stimulating agents (ESAs) in cancer patients from EMA and identified RCT publications with literature searches.
Bioresorbable scaffolds: in search of event-free dissolution
2-year outcomes with the Absorb bioresorbable scaffold for treatment of coronary artery disease: a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy
Preprocedural High-Sensitivity Cardiac Troponin T and Clinical Outcomes in Patients With Stable Coronary Artery Disease Undergoing Elective Percutaneous Coronary Intervention
Background— Cardiac troponin detected by new-generation, highly sensitive assays predicts clinical outcomes among patients with stable coronary artery disease (SCAD) treated medically. The prognostic value of baseline high-sensitivity cardiac troponin T (hs-cTnT) elevation in SCAD patients undergoing elective percutaneous coronary interventions is not well established.
Post‐Procedural Troponin Elevation and Clinical Outcomes Following Transcatheter Aortic Valve Implantation
Methods and Results We evaluated 577 consecutive patients with severe aortic stenosis treated with TAVI between 2007 and 2012. Myocardial injury, defined according to the Valve Academic Research Consortium (VARC)‐2 as post‐TAVI cardiac troponin T (cTnT) >15× the upper limit of normal, occurred in 338 patients (58.1%).
Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation
Background The Valve Academic Research Consortium (VARC) has proposed a standardized definition of bleeding in patients undergoing transcatheter aortic valve interventions (TAVI). The VARC bleeding definition has not been validated or compared to other established bleeding definitions so far. Thus, we aimed to investigate the impact of bleeding and compare the predictivity of VARC bleeding events with established bleeding definitions.
Impact of Diabetic Status on Outcomes After Revascularization With Drug-Eluting Stents in Relation to Coronary Artery Disease Complexity
Background— Diabetes mellitus and angiographic coronary artery disease complexity are intertwined and unfavorably affect prognosis after percutaneous coronary interventions, but their relative impact on long-term outcomes after percutaneous coronary intervention with drug-eluting stents remains controversial.
Clinical Outcomes According to Diabetic Status in Patients Treated With Biodegradable Polymer Sirolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents
Background— Ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES) proved noninferior to durable polymer everolimus-eluting stents (DP-EES) for a composite clinical end point in a population with minimal exclusion criteria.
Clinical Impact of Gastrointestinal Bleeding in Patients Undergoing Percutaneous Coronary Interventions
Background— The risk factors and clinical sequelae of gastrointestinal bleeding (GIB) in the current era of drug-eluting stents, prolonged dual antiplatelet therapy, and potent P2Y 12 inhibitors are not well established. We determined the frequency, predictors, and clinical impact of GIB after percutaneous coronary interventions (PCIs) in a contemporary cohort of consecutive patients treated with unrestricted use of drug-eluting stents.
Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland
Methods and Results—In a nationwide, prospective, multicenter cohort study (Swiss Transcatheter Aortic Valve Implantation Registry, NCT01368250), outcomes of consecutive transfemoral transcatheter aortic valve implantation patients treated with the Sapien 3 THV (S3) versus the Sapien XT THV (XT) were investigated. An overall of 153 consecutive S3 patients were compared with 445 consecutive XT patients.
The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials
Julian P T Higgins, senior statistician, Douglas G Altman, director , Peter C Gøtzsche, director , Peter Jüni, head of division , David Moher, senior scientist, Andrew D Oxman, senior researcher, Jelena Savović, postdoctoral fellow, Kenneth F Schulz, vice president, Laura Weeks, research associate, Jonathan A C Sterne, professor of medical statistics and epidemiology Cochrane Bias Methods Group Cochrane Statistical Methods Group Author affiliations Correspondence to: J P T Higgins...
Assessing the quality of controlled clinical trials
Intended for healthcare professionals Toggle navigation The BMJ logo Toggle top menu Assessing the quality...
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