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- Imran, Mahrukh, et al.
(author)
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Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE)
- 2021
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In: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 11:4
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Journal article (peer-reviewed)abstract
- OBJECTIVES: Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist.METHODS: The development process involved five stages: (1) identification of the need for a reporting guideline and project launch; (2) conduct of a scoping review to identify possible modifications to CONSORT 2010 checklist items and possible new extension items; (3) a three-round modified Delphi study involving key stakeholders to gather feedback on the checklist; (4) a consensus meeting to finalise items to be included in the extension, followed by stakeholder piloting of the checklist; and (5) publication, dissemination and implementation of the final checklist.RESULTS: 27 items were initially developed and rated in Delphi round 1, 13 items were rated in round 2 and 11 items were rated in round 3. Response rates for the Delphi study were 92 of 125 (74%) invited participants in round 1, 77 of 92 (84%) round 1 completers in round 2 and 62 of 77 (81%) round 2 completers in round 3. Twenty-seven members of the project team representing a variety of stakeholder groups attended the in-person consensus meeting. The final checklist includes five new items and eight modified items. The extension Explanation & Elaboration document further clarifies aspects that are important to report.CONCLUSION: Uptake of CONSORT-ROUTINE and accompanying Explanation & Elaboration document will improve conduct of trials, as well as the transparency and completeness of reporting of trials conducted using cohorts and routinely collected data.
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| 2. |
- Kwakkenbos, Linda, et al.
(author)
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CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) : checklist with explanation and elaboration
- 2021
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In: The BMJ. - : BMJ Publishing Group Ltd. - 1756-1833 .- 0959-8146. ; 373
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Journal article (peer-reviewed)abstract
- Randomised controlled trials are increasingly conducted as embedded, nested, or using cohorts or routinely collected data, including registries, electronic health records, and administrative databases, to assess if participants are eligible for the trial and to facilitate recruitment, to deliver an embedded intervention, to collect trial outcome data, or a combination of these purposes. This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE). The extension was developed to look at the unique characteristics of trials conducted with these types of data with the goal of improving reporting quality in the long term by setting standards early in the process of uptake of these trial designs. The extension was developed with a sequential approach, including a Delphi survey, a consensus meeting, and piloting of the checklist. The checklist was informed by the CONSORT 2010 statement and two reporting guidelines for observational studies, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement and the REporting of studies Conducted using Observational Routinely collected Data (RECORD) statement. The extension includes eight items modified from the CONSORT 2010 statement and five new items. Reporting items with explanations and examples are provided, including key aspects of trials conducted using cohorts or routinely collected data that require specific reporting considerations.
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| 3. |
- Andell, Pontus, et al.
(author)
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Oxygen therapy in suspected acute myocardial infarction and concurrent normoxemic chronic obstructive pulmonary disease : a prespecified subgroup analysis from the DETO2X-AMI trial.
- 2020
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In: European Heart Journal. - : Oxford University Press (OUP). - 2048-8726 .- 2048-8734. ; 9:8, s. 984-992
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Journal article (peer-reviewed)abstract
- BACKGROUND: The DETermination of the role of Oxygen in suspected Acute Myocardial Infarction (DETO2X-AMI) trial did not find any benefit of oxygen therapy compared to ambient air in normoxemic patients with suspected acute myocardial infarction. Patients with chronic obstructive pulmonary disease may both benefit and be harmed by supplemental oxygen. Thus we evaluated the effect of routine oxygen therapy compared to ambient air in normoxemic chronic obstructive pulmonary disease patients with suspected acute myocardial infarction.METHODS AND RESULTS: =0.77]); there were no significant treatment-by-chronic obstructive pulmonary disease interactions.CONCLUSIONS: Although chronic obstructive pulmonary disease patients had twice the mortality rate compared to non-chronic obstructive pulmonary disease patients, this prespecified subgroup analysis from the DETO2X-AMI trial on oxygen therapy versus ambient air in normoxemic chronic obstructive pulmonary disease patients with suspected acute myocardial infarction revealed no evidence for benefit of routine oxygen therapy consistent with the main trial's findings.CLINICAL TRIALS REGISTRATION: NCT02290080.
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| 8. |
- Lav, Theodor, et al.
(author)
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Non-invasive pressure volume loops derived by cardiovascular magnetic resonance: association between area at risk or infarct size and cardiac hemodynamics at 2-6 days after myocardial infarction
- 2023
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Conference paper (peer-reviewed)abstract
- BackgroundA novel non-invasive method for generation of pressure volume loops (PV-loops) using brachial blood pressure and cardiovascular magnetic resonance (CMR) imaging has recently been presented and validated (1). The non-invasive nature of this method enables calculation of PV-loops in large patient cohorts previously not feasible due to the need of invasive measurements.PurposeThe purpose of the present study was to investigate how cardiac hemodynamics assessed by PV-loop variables such as stroke work, potential energy, contractility and ventriculoarterial coupling is related to myocardium at risk and infarct size in a cohort of patients with acute myocardial infarction (MI).MethodA total of 100 patients with ST-elevation MI (STEMI) were included from the SOCCER, MITOCARE and CHILL-MI trials (2-4). The CHILL-MI cohort (n = 11) was prone to a stricter selection criterion than the SOCCER cohort, including first-time myocardial infarction and no comorbidities. All patients underwent a CMR examination at 2-6 days after MI. Non-invasive PV-loops were generated by combining volumetric CMR data and brachial sphygmomanometric pressure measurements using a recently validated method (1). Maximal elastance (Emax, translated to contractility), stroke work, potential energy and ventriculoarterial coupling (Ea/Emax) were measured from the PV-loops. Myocardium at risk and infarct size were assessed using contrast-enhanced steady state free precession and late gadolinium enhancement images, respectively.ResultsContractility, ventriculoarterial coupling, stroke work and potential energy all correlated to myocardium at risk (Emax: r²=0.25, Ea/Emax: r²=0.36, stroke work: r²=0.21, potential energy: r²=0.10) and infarct size (Emax: r²=0.29, Ea/Emax: r²=0.41, stroke work: r²=0.25, potential energy: r²=0.15) as shown in Figure 1. Furthermore, contractility showed a stronger correlation to myocardium at risk (Emax: r²=0.77) than to infarct size (Emax: r²=0.37) for the CHILL-MI patients as shown in Figure 2.ConclusionNon-invasive CMR derived PV-loop parameters can be used to assess cardiac hemodynamics early after STEMI showing that increased myocardium at risk and infarct size are both associated with an increased ventriculoarterial coupling and potential energy, and a decreased contractility and stroke work. To what extent these hemodynamic parameters provide incremental prognostic information compared to conventional parameters such as ejection fraction and left ventricular dimensions after STEMI remains to be determined.
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| 9. |
- Lundin, Magnus, et al.
(author)
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Prognostic utility and characterization of left ventricular hypertrophy using global thickness
- 2023
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In: Scientific Reports. - 2045-2322. ; 13:1
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Journal article (peer-reviewed)abstract
- Cardiovascular magnetic resonance (CMR) can accurately measure left ventricular (LV) mass, and several measures related to LV wall thickness exist. We hypothesized that prognosis can be used to select an optimal measure of wall thickness for characterizing LV hypertrophy. Subjects having undergone CMR were studied (cardiac patients, n = 2543; healthy volunteers, n = 100). A new measure, global wall thickness (GT, GTI if indexed to body surface area) was accurately calculated from LV mass and end-diastolic volume. Among patients with follow-up (n = 1575, median follow-up 5.4 years), the most predictive measure of death or hospitalization for heart failure was LV mass index (LVMI) (hazard ratio (HR)[95% confidence interval] 1.16[1.12-1.20], p < 0.001), followed by GTI (HR 1.14[1.09-1.19], p < 0.001). Among patients with normal findings (n = 326, median follow-up 5.8 years), the most predictive measure was GT (HR 1.62[1.35-1.94], p < 0.001). GT and LVMI could characterize patients as having a normal LV mass and wall thickness, concentric remodeling, concentric hypertrophy, or eccentric hypertrophy, and the three abnormal groups had worse prognosis than the normal group (p < 0.05 for all). LV mass is highly prognostic when mass is elevated, but GT is easily and accurately calculated, and adds value and discrimination amongst those with normal LV mass (early disease).
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| 10. |
- Mokhtari, Arash, et al.
(author)
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Oxygen therapy in patients with ST elevation myocardial infarction based on the culprit vessel: results from the randomized controlled SOCCER trial
- 2020
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In: BMC Emergency Medicine. - : Springer Science and Business Media LLC. - 1471-227X. ; 20, s. 1-10
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Journal article (peer-reviewed)abstract
- Background: Oxygen (O2) treatment has been a cornerstone in the treatment of patients with myocardial infarction. Recent studies, however, state that supplemental O2 therapy may have no effect or harmful effects in these patients. The aim of this study was thus to evaluate the effect of O2 therapy in patients with ST Elevation Myocardial Infarction (STEMI) based on the culprit vessel; Left Anterior Descending Artery (LAD) or Non-LAD.Methods: This was a two-center, investigator-initiated, single-blind, parallel-group, randomized controlled trial at the Skåne university hospital, Sweden. A simple computer-generated randomization was used. Patients were eitherrandomized to standard care with O2 therapy (10 l/min) or air until the end of the primary percutaneous coronary intervention. The patients underwent a Cardiac Magnetic Resonance Imaging (CMRI) days 2–6. The main outcome measures were Myocardium at Risk (MaR), Infarct Size (IS) and Myocardial Salvage Index (MSI) as measured by CMRI, and median high-sensitive troponin T (hs-cTnT).Results: A total of 229 patients were assessed for eligibility, and 160 of them were randomized to the oxygen or air arm. Because of primarily technical problems with the CMRI, 95 patients were included in the final analyses; 46 inthe oxygen arm and 49 in the air arm. There were no significant differences between patients with LAD and NonLAD as culprit vessel with regard to their allocation (oxygen or air) with regards to MSI, MaR, IS and hs-cTnT.Conclusion: The results indicate that the location of the culprit vessel has probably no effect on the role of supplemental oxygen therapy in STEMI patients.
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