ORCID Profile
0000-0002-5985-0670
Current Organisations
University of Oxford
,
University of Toronto
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Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 12-10-2021
DOI: 10.1161/CIRCULATIONAHA.121.056680
Abstract: The optimal duration of antiplatelet therapy (APT) in patients at high bleeding risk with or without oral anticoagulation (OAC) after coronary stenting remains unclear. In the investigator-initiated, randomize, open-label MASTER DAPT trial (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen), 4579 patients at high bleeding risk were randomized after 1-month dual APT to abbreviated or nonabbreviated APT strategies. Randomization was stratified by concomitant OAC indication. In this subgroup analysis, we report outcomes of populations with or without an OAC indication. In the population with an OAC indication, patients changed immediately to single APT for 5 months (abbreviated regimen) or continued ≥2 months of dual APT and single APT thereafter (nonabbreviated regimen). Patients without an OAC indication changed to single APT for 11 months (abbreviated regimen) or continued ≥5 months of dual APT and single APT thereafter (nonabbreviated regimen). Coprimary outcomes at 335 days after randomization were net adverse clinical outcomes (composite of all-cause death, myocardial infarction, stroke, and Bleeding Academic Research Consortium 3 or 5 bleeding events) major adverse cardiac and cerebral events (all-cause death, myocardial infarction, and stroke) and type 2, 3, or 5 Bleeding Academic Research Consortium bleeding. Net adverse clinical outcomes or major adverse cardiac and cerebral events did not differ with abbreviated versus nonabbreviated APT regimens in patients with OAC indication (n=1666 hazard ratio [HR], 0.83 [95% CI, 0.60–1.15] and HR, 0.88 [95% CI, 0.60–1.30], respectively) or without OAC indication (n=2913 HR, 1.01 [95% CI, 0.77–1.33] or HR, 1.06 [95% CI, 0.79–1.44] P interaction =0.35 and 0.45, respectively). Bleeding Academic Research Consortium 2, 3, or 5 bleeding did not significantly differ in patients with OAC indication (HR, 0.83 [95% CI, 0.62–1.12]) but was lower with abbreviated APT in patients without OAC indication (HR, 0.55 [95% CI, 0.41–0.74] P interaction =0.057). The difference in bleeding in patients without OAC indication was driven mainly by a reduction in Bleeding Academic Research Consortium 2 bleedings (HR, 0.48 [95% CI, 0.33–0.69] P interaction =0.021). Rates of net adverse clinical outcomes and major adverse cardiac and cerebral events did not differ with abbreviated APT in patients with high bleeding risk with or without an OAC indication and resulted in lower bleeding rates in patients without an OAC indication. URL: www.clinicaltrials.gov Unique identifier: NCT03023020.
Publisher: Springer Science and Business Media LLC
Date: 24-08-2020
DOI: 10.1186/S13063-020-04641-3
Abstract: Primary objective: To estimate the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization. Secondary objectives: To examine whether the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization varies between subgroups related to treatment characteristics, disease severity at the time of randomization, patient characteristics, or risk of bias. To examine the effect of corticosteroids compared with usual care or placebo on serious adverse events. Prospective meta-analysis of randomized controlled trials. Both placebo-controlled and open-label trials are eligible. Hospitalised, critically ill patients with suspected or confirmed COVID-19. Intervention groups will have received therapeutic doses of a steroid (dexamethasone, hydrocortisone or methylprednisolone) with IV or oral administration immediately after randomization. The comparator groups will have received standard of care or usual care or placebo. All-cause mortality up to 28 days after randomization. Systematic searching of clinicaltrials.gov , EudraCT, the WHO ISRCTN registry, and the Chinese clinical trials registry. Additionally, research and WHO networks will be asked for relevant trials. These will be based on the Cochrane RoB 2 tool, and will use structured information provided by the trial investigators on a form designed for this prospective meta-analysis. We will use GRADE to assess the certainty of the evidence. Trial investigators will provide data on the numbers of participants who did and did not experience each outcome according to intervention group, overall and in specified subgroups. We will conduct fixed-effect (primary analysis) and random-effects (Paule-Mandel estimate of heterogeneity and Hartung-Knapp adjustment) meta-analyses. We will quantify inconsistency in effects between trials using I 2 statistics. Evidence for subgroup effects will be quantified by ratios of odds ratios comparing effects in the subgroups, and corresponding interaction p-values. Comparisons between subgroups defined by trial characteristics will be made using random-effects meta-regression. Comparisons between subgroups defined by patient characteristics will be made by estimating trial-specific ratios of odds ratios comparing intervention effects between subgroups then combining these using random-effects meta-analysis. Steroid interventions will be classified as high or low dose according to whether the dose is greater or less than or equal to 400 mg hydrocortisone per day or equivalent. We will use network meta-analysis methods to make comparisons between the effects of high and low dose steroid interventions (because one trial randomized participants to both low and high dose steroid arms). CRD42020197242 The full protocol for this prospective meta-analysis is attached as an additional file, accessible from the Trials website (Additional file 1). To expedite dissemination of this material, the familiar formatting has been eliminated this Letter serves as a summary of the key elements of the full protocol for the systematic review.
Publisher: BMJ
Date: 28-08-2007
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 15-03-2022
DOI: 10.1161/CIRCULATIONAHA.121.057687
Abstract: The clinical implications of hypertension in addition to a high prevalence of both uncontrolled blood pressure and medication nonadherence promote interest in developing device-based approaches to hypertension treatment. The expansion of device-based therapies and ongoing clinical trials underscores the need for consistency in trial design, conduct, and definitions of clinical study elements to permit trial comparability and data poolability. Standardizing methods of blood pressure assessment, effectiveness measures beyond blood pressure alone, and safety outcomes are paramount. The Hypertension Academic Research Consortium (HARC) document represents an integration of evolving evidence and consensus opinion among leading experts in cardiovascular medicine and hypertension research with regulatory perspectives on clinical trial design and methodology. The HARC document integrates the collective information among device-based therapies for hypertension to better address existing challenges and identify unmet needs for technologies proposed to treat the world’s leading cause of death and disability. Consistent with the Academic Research Consortium charter, this document proposes pragmatic consensus clinical design principles and outcomes definitions for studies aimed at evaluating device-based hypertension therapies.
Publisher: SAGE Publications
Date: 18-12-2018
Abstract: Increased thickness of subchondral acetabular bone with associated articular cartilage thinning in hips with femoroacetabular (FAI) cam impingement has been observed on magnetic resonance imaging (MRI). Dynamic attrition by the cam deformity moving into the acetabulum may potentiate trans-articular shear stresses thus causing these subchondral bone changes. We aimed to quantify the hypertrophic changes of subchondral acetabular bone in patients with cam-type FAI. MRI studies were performed on an asymptomatic population of young Swiss army recruits. Subjects underwent clinical examination and completed questionnaires before undergoing an MRI of the hip. Cam deformities were graded and the dimensions of the acetabular subchondral bone quantified. Univariate linear regression was used to determine the association between the presence of cam deformities and the degree of subchondral acetabular sclerosis. There was a strong association between cam deformities and the thickness, area and shape of subchondral sclerosis. The main increase in hypertrophy was observed in the antero-superior acetabulum where impingement typically occurs. The subchondral sclerosis was 0.66 mm thicker in cam-type deformities than in hips without cam-type deformities (95% CI, 0.38-0.93, Mechanical stress in the antero-superior acetabular area is elevated in hips with a cam-type deformity. The study supports the concept that cam-type deformity induced stress leads to hypertrophy of subchondral acetabular bone in the area of impingement. This is collocated with the clinically observed cartilage damage caused by the cam mechanism.
Publisher: American Medical Association (AMA)
Date: 06-10-2020
Publisher: American Medical Association (AMA)
Date: 26-05-2015
Publisher: Oxford University Press (OUP)
Date: 26-08-2017
DOI: 10.1093/EJCTS/EZX334
Publisher: European Respiratory Society (ERS)
Date: 31-08-2019
Publisher: Oxford University Press (OUP)
Date: 26-08-2017
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 21-07-2020
Abstract: Loss to follow‐up ( LTFU ) is common in randomized controlled trials. However, its potential impact on primary outcomes from cardiovascular randomized controlled trials is not known. We conducted a prospective systematic review ( PROSPERO : CRD 42019121959) for randomized controlled trials published in 8 leading journals over 5 years from January 2014 to December 2018. Extent, reporting, and handling of LTFU data were recorded, and the proportion of a trial's primary outcome results that lose statistical significance was calculated after making plausible assumptions for the intervention and control arms. These assumptions could drive differential treatment effects between the groups considering relative event incidence between LTFU participants and those included in the primary outcome. We identified 117 randomized controlled trials of which 91 (78%) trials reported LTFU , 23 (20%) reported no LTFU , and 3 (3%) trials did not report on whether LTFU occurred. The median percentage of study participants lost to follow‐up was 2% (interquartile range, 0.33%–5.3%). Only 10 trials (9%) had a low cluster of risk factors for impairment in trial quality. The percentage of trials losing statistical significance varied from 2% when the relative event incidence for LTFU between the randomized groups was 1 for the intervention arm and 1.5 for the control arm to 16% when the relative event incidence was 3 for the intervention arm and 1 for the control arm. Almost 1 in 6 (16%) cardiovascular randomized trials published in leading journals may have a change in the primary outcome if plausible assumptions are made about differential event rates of participants lost to follow up. There is scope for improvement arising from LTFU in randomized trials in cardiovascular medicine. URL : www.crd.york.ac.uk rospero Unique identifier: CRD 42019121959.
Publisher: Oxford University Press (OUP)
Date: 24-07-2023
Publisher: Oxford University Press (OUP)
Date: 26-08-2017
Publisher: Massachusetts Medical Society
Date: 27-09-2018
Publisher: Wiley
Date: 17-11-2022
DOI: 10.1111/DOM.14591
Abstract: To characterize the association between diabetes and transfusion and clinical outcomes in cardiac surgery, and to evaluate whether restrictive transfusion thresholds are harmful in these patients. The multinational, open‐label, randomized controlled TRICS‐III trial assessed a restrictive transfusion strategy (haemoglobin [Hb] transfusion threshold g/L) compared with a liberal strategy (Hb g/L for operating room or intensive care unit or g/L for ward) in patients undergoing cardiac surgery on cardiopulmonary bypass with a moderate‐to‐high risk of death (EuroSCORE ≥6). Diabetes status was collected preoperatively. The primary composite outcome was all‐cause death, stroke, myocardial infarction, and new‐onset renal failure requiring dialysis at 6 months. Secondary outcomes included components of the composite outcome at 6 months, and transfusion and clinical outcomes at 28 days. Of the 5092 patients analysed, 1396 (27.4%) had diabetes (restrictive, n = 679 liberal, n = 717). Patients with diabetes had more cardiovascular disease than patients without diabetes. Neither the presence of diabetes (OR [95% CI] 1.10 [0.93‐1.31]) nor the restrictive strategy increased the risk for the primary composite outcome (diabetes OR [95% CI] 1.04 [0.68‐1.59] vs. no diabetes OR 1.02 [0.85‐1.22] P interaction = .92). In patients with versus without diabetes, a restrictive transfusion strategy was more effective at reducing red blood cell transfusion (diabetes OR [95% CI] 0.28 [0.21‐0.36] no diabetes OR [95% CI] 0.40 [0.35‐0.47] P interaction = .04). The presence of diabetes did not modify the effect of a restrictive transfusion strategy on the primary composite outcome, but improved its efficacy on red cell transfusion. Restrictive transfusion triggers are safe and effective in patients with diabetes undergoing cardiac surgery.
Publisher: The Journal of Rheumatology
Date: 15-09-2015
Abstract: To assess the current state of reporting of pain outcomes in Cochrane reviews on chronic musculoskeletal painful conditions and to elicit opinions of patients, healthcare practitioners, and methodologists on presenting pain outcomes to patients, clinicians, and policymakers. We identified all reviews in the Cochrane Library of chronic musculoskeletal pain conditions from Cochrane review groups (Back, Musculoskeletal, and Pain, Palliative, and Supportive Care) that contained a summary of findings (SoF) table. We extracted data on reported pain domains and instruments and conducted a survey and interviews on considerations for SoF tables (e.g., pain domains, presentation of results). Fifty-seven SoF tables in 133 Cochrane reviews were eligible. SoF tables reported pain in 56/57, with all presenting results for pain intensity (20 different outcome instruments), pain interference in 8 SoF tables (5 different outcome instruments), and pain frequency in 1 multiple domain instrument. Other domains like pain quality or pain affect were not reported. From the survey and interviews [response rate 80% (36/45)], we derived 4 themes for a future research agenda: pain domains, considerations for assessing truth, discrimination, and feasibility clinically important thresholds for responder analyses and presenting results and establishing hierarchies of outcome instruments. There is a lack of standardization in the domains of pain selected and the manner that pain outcomes are reported in SoF tables, h ering efforts to synthesize evidence. Future research should focus on the themes identified, building partnerships to achieve consensus and develop guidance on best practices for reporting pain outcomes.
Publisher: Elsevier BV
Date: 2013
Publisher: BMJ
Date: 13-05-2014
DOI: 10.1136/BMJ.G3009
Publisher: The Journal of Rheumatology
Date: 05-2015
Abstract: Although protocol registration for systematic reviews is still not mandatory, reviewers should be strongly encouraged to register the protocol to identify the methodological approach, including all outcomes of interest. This will minimize the likelihood of biased decisions in reviews, such as selective outcome reporting. A group of international experts convened to address issues regarding the need to develop hierarchical lists of outcome measurement instruments for a particular outcome for metaanalyses. Multiple outcome measurement instruments exist to measure the same outcome. Metaanalysis of knee osteoarthritis (OA) trials, and the assessment of pain as an outcome, was used as an exemplar to assess how Outcome Measures in Rheumatology (OMERACT), the Cochrane Collaboration, and other international initiatives might contribute in this area. The meeting began with formal presentations of background topics, empirical evidence from the literature, and a brief introduction to 2 existing hierarchical lists of pain outcome measurement instruments recommended for metaanalyses of knee OA trials. After discussions, most participants agreed that there is a need to develop a methodology for generation of hierarchical lists of outcome measurement instruments to guide metaanalyses. Tools that could be used to steer development of such a prioritized list are the COSMIN checklist (COnsensus-based Standards for the selection of health status Measurement Instruments) and the OMERACT Filter 2.0. We list meta-epidemiological research agenda items that address the frequency of reported outcomes in trials, as well as methodologies to assess the best measurement properties (i.e., truth, discrimination, and feasibility).
Publisher: Elsevier BV
Date: 2018
Publisher: BMJ
Date: 12-10-2016
DOI: 10.1136/BMJ.I4919
Publisher: Springer Science and Business Media LLC
Date: 25-11-2021
DOI: 10.1038/S41467-021-27215-6
Abstract: Identifying febrile children at risk of sepsis in low-resource settings can improve survival, but recognition triage tools are lacking. Here we test the hypothesis that measuring circulating markers of immune and endothelial activation may identify children with sepsis at risk of all-cause mortality. In a prospective cohort study of 2,502 children in Uganda, we show that Soluble Triggering Receptor Expressed on Myeloid cells-1 (sTREM-1) measured at first clinical presentation, had high predictive accuracy for subsequent in-hospital mortality. sTREM-1 had the best performance, versus 10 other markers, with an AUROC for discriminating children at risk of death of 0.893 in derivation (95% CI 0.843–0.944) and 0.901 in validation (95% CI 0.856–0.947) cohort. sTREM-1 cutoffs corresponding to a negative likelihood ratio (LR) of 0.10 and a positive LR of 10 classified children into low (1,306 children, 53.1%), intermediate (942, 38.3%) and high (212, 8.6%) risk zones. The estimated incidence of death was 0.5%, 3.9%, and 31.8%, respectively, suggesting sTREM-1 could be used to risk-stratify febrile children. These findings do not attempt to derive a risk prediction model, but rather define sTREM-1 cutoffs as the basis for rapid triage test for all cause fever syndromes in children in low-resource settings.
Publisher: Massachusetts Medical Society
Date: 28-10-2021
Publisher: BMJ
Date: 02-2017
Location: United Kingdom of Great Britain and Northern Ireland
Location: Switzerland
Location: Switzerland
No related grants have been discovered for Peter Jüni.