Background The respiratory illness caused by SARS‐CoV‐2 infection continues to present diagnostic challenges. Our 2020 edition of this review showed thoracic (chest) imaging to be sensitive and moderately specific in the diagnosis of coronavirus disease 2019 (COVID‐19). In this update, we include new relevant studies, and have removed studies with case‐control designs, and those not intended to be diagnostic test accuracy studies. Objectives To evaluate the diagnostic accuracy of thoracic imaging (computed tomography (CT), X‐ray and ultrasound) in people with suspected COVID‐19. Search methods We searched the COVID‐19 Living Evidence Database from the University of Bern, the Cochrane COVID‐19 Study Register, The Stephen B. Thacker CDC Library, and repositories of COVID‐19 publications through to 30 September 2020. We did not apply any language restrictions. Selection criteria We included studies of all designs, except for case‐control, that recruited participants of any age group suspected to have COVID‐19 and that reported estimates of test accuracy or provided data from which we could compute estimates. Data collection and analysis The review authors independently and in duplicate screened articles, extracted data and assessed risk of bias and applicability concerns using the QUADAS‐2 domain‐list. We presented the results of estimated sensitivity and specificity using paired forest plots, and we summarised pooled estimates in tables. We used a bivariate meta‐analysis model where appropriate. We presented the uncertainty of accuracy estimates using 95% confidence intervals (CIs). Main results We included 51 studies with 19,775 participants suspected of having COVID‐19, of whom 10,155 (51%) had a final diagnosis of COVID‐19. Forty‐seven studies evaluated one imaging modality each, and four studies evaluated two imaging modalities each. All studies used RT‐PCR as the reference standard for the diagnosis of COVID‐19, with 47 studies using only RT‐PCR and four studies using a combination of RT‐PCR and other criteria (such as clinical signs, imaging tests, positive contacts, and follow‐up phone calls) as the reference standard. Studies were conducted in Europe (33), Asia (13), North America (3) and South America (2); including only adults (26), all ages (21), children only (1), adults over 70 years (1), and unclear (2); in inpatients (2), outpatients (32), and setting unclear (17). Risk of bias was high or unclear in thirty‐two (63%) studies with respect to participant selection, 40 (78%) studies with respect to reference standard, 30 (59%) studies with respect to index test, and 24 (47%) studies with respect to participant flow. For chest CT (41 studies, 16,133 participants, 8110 (50%) cases), the sensitivity ranged from 56.3% to 100%, and specificity ranged from 25.4% to 97.4%. The pooled sensitivit...
Background: Adherence to study registration and reporting best practices are vital to foster evidence-based medicine. Poor adherence to these standards in clinical trials conducted in Canada would be detrimental to patients, researchers, and the public alike. Methods: All registered clinical trials on ClinicalTrials.gov conducted in Canada as of 2009 and completed by 2019 were identified. A cross-sectional analysis of those trials assessed prospective registration, subsequent result reporting in the registry, and subsequent publication of study findings. The lead sponsor, phase of study, clinical trial site location, total patient enrollment, number of arms, type of masking, type of allocation, year of completion, and patient demographics were examined as potential effect modifiers to these best practices. Results: A total of 6,720 trials met the inclusion criteria. From 2009-2019, 59% (n=3,967) of them were registered prospectively and 39% (n=2,642) reported their results in the registry. Of the trials registered between 2009-2014, 55% (n=1,482) were subsequently published in an academic journal. Of the 3,763 trials conducted exclusively in Canada, 3% (n=123) met all 3 criteria of: prospective registration, reporting in the registry, and publishing findings. In contrast, of the remaining 2,957 trials with both Canadian and international sites, 41% (n=1,238) had an overall compliance to these three criteria. Overall, the odds of having adherence to all three practices concurrently in Canadian trials decreases by 95% when compared to international trials (OR = 0.05; 95CI: 0.04 – 0.06). Conclusion: Canadian clinical trials substantially lacked adherence to study registration and reporting best practices. Knowledge of this widespread non-compliance should motivate stakeholders in the Canadian clinical trials ecosystem to address and continue to monitor this problem. The data presented provides a baseline against which to compare any improvement in the registration and reporting of clinical trials in Canada.
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