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- Juszczak, Edmund, et al.
(författare)
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Introducing the CONsolidated Standards of Reporting Trials (CONSORT) statement for randomised controlled trials (RCTs) using cohorts and routinely collected health data
- 2019
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Ingår i: Trials. - : BMC. - 1745-6215. ; 20:Suppl. 1, s. 131-131
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Background: Randomised controlled trials (RCTs) are increasingly being conducted using existing sources of data, such as cohorts, administrative databases, disease registries and electronic health records. RCTs conducted using existing data sources require additional information to be reported. This reporting guideline is an extension of the 2010 version of the Consolidated Standards of Reporting Trials (CONSORT) Statement for RCTs using cohorts and routinely collected health data.Methods: A long-list of potential items for the checklist was identified through two methods: firstly, modifications to the current CONSORT checklist were generated using existing reporting guidelines, including the Reporting of Observational Studies in Epidemiology (STROBE) and REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Secondly, ascoping review of RCTs conducted in the last decade using cohorts and routinely collected health data facilitated the modification and identification of other potential items. Using the long-list, a three-stage Delphi exercise was conducted to assess the importance of each item for inclusion in the final extension checklist, which was finalised at a face-to-face meeting of experts.Results: A long-list of 27 items was created and 125 experts registered for the three-round Delphi exercise (92, 77 and 62 experts participated in each round respectively). Consensus was reached on 21 out of 27 items. The results of the Delphi exercise informed a face-to-face consensus meeting in May 2019; core items to be included in the extension checklist were finalised at this meeting. Corresponding explanations of extensions and new items with examples of good reporting were developed subsequently.Conclusion: The guideline checklist can facilitate transparent reporting of RCTs using cohorts and routinely collected health data, to assist evaluations of rigour and reproducibility, enhance understanding of the methodology, and make the results more useful for clinicians, journal editors, reviewers, guideline authors, and funders.
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- Lundin, Magnus, et al.
(författare)
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Left ventricular global wall thickness is easily calculated, detects and characterizes hypertrophy, and has prognostic utility
- 2019
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- BACKGROUND: Cardiovascular magnetic resonance (CMR) can be used to measure left ventricular end-diastolic volume (LVEDV) and left ventricular mass (LVM). However, there is currently no good way to measure the normality of LVM in relation to a given LVEDV. We hypothesized that a simple measure of left ventricular global wall thickness (GWT) would be accurate, beneficial for detecting and characterizing hypertrophy, and have prognostic significance.METHODS: Subjects underwent CMR at 1.5T, including healthy volunteers (n=99) and patients assessed for heart disease (n=2828).RESULTS: GWT calculated from LVEDV and LVM had excellent agreement with measured mean end-diastolic wall thickness of the entire left ventricle (bias 0.01±0.23mm). GWT was most predictive of death or hospitalization for heart failure in patients with normal findings by CMR (n=326, log-rank 26.8, p<0.001, median [interquartile range] follow-up 5.8 [5.0–6.7] years). GWT indexed to body surface area (GWTi) was most predictive of outcomes in patients with normal LVEDV index (n=1352, log-rank 36.4, p<0.001, follow-up 5.5 [4.1–6.5] years). Patients with concentric remodeling had worse prognosis than the normal patients (p=0.02), and the patients with hypertrophy had worse prognosis than both normal patients (p<0.001) and patients with concentric remodeling (p=0.045), see Figure 1. Of patients with suspected heart disease but normal CMR findings regarding left ventricular volumes, function, mass, and scar, 22% were found to have increased mean GWTi corresponding to concentric remodeling, see Figure 2.CONCLUSIONS: Left ventricular GWT is an intuitive measure that can be easily calculated from mass and volume with high accuracy, and has prognostic utility in patients with normal CMR findings. Also, GWTi classifies hypertrophy as concentric or eccentric, and detects concentric remodeling in a substantial portion of patients with otherwise normal findings.
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