Electronic informed consent: effects on enrolment, practical and economic benefits, challenges, and drawbacks-a systematic review of studies within randomized controlled trials.

BACKGROUND: Enrolment is one of the most challenging aspects of conducting clinical trials, preceded by the process of informed consent (IC). Different strategies to improve recruitment in clinical trials have been used, including electronic IC. During COVID-19 pandemic, barriers to enrolment have been evident. Although digital technologies were acknowledged as the future of clinical research and potential advantages were shown for recruitment, electronic informed consent (e-IC) has not yet been globally adopted. The purpose of this review is to investigate the effect of using e-IC on enrolment, practical and economic benefits, challenges, and drawbacks when compared to traditional informed consent, through a systematic review. METHODS: Embase, Global Health Library, Medline, and The Cochrane Library databases were searched. No limit was set for publication date, age, sex, or study design. We included all studies within a randomized controlled trial (RCT), published in English, Chinese or Spanish, evaluating the electronic consent process used in the parent RCT. Studies were included if any of the three components ((i) information provision, (ii) participant's comprehension, (iii) signature) of the IC process was designed as electronic, whether administered remotely or face-to-face. The primary outcome was the rate of enrolment to the parent trial. Secondary outcomes were summarized according to the various findings reported on the use of electronic consent. RESULTS: From a total of 9069 titles, 12 studies were included in the final analysis with a total of 8864 participants. Five studies of high heterogeneity and risk of bias showed mixed results on the efficacy of e-IC on enrolment. Data of included studies suggested e-IC could improve comprehension and recall of study-related information. Meta-analysis could not be conducted due to different study designs and outcome measures and the predominantly qualitative findings. CONCLUSION: Few published studies have investigated the impact of e-IC on enrolment and findings were mixed. e-IC may improve participant's comprehension and recall of information. High-quality studies are needed to evaluate the potential benefit of e-IC to increase clinical trial enrolment. TRIAL REGISTRATION: PROSPERO CRD42021231035 . Registration date: 19-Feb-2021.

Appearance of COVID-19 pneumonia on 1.5 T TrueFISP MRI.

OBJECTIVE: To evaluate the performance of 1.5 T true fast imaging with steady state precession (TrueFISP) magnetic resonance imaging (MRI) sequences for the detection and characterization of pulmonary abnormalities caused by coronavirus disease 2019 (COVID-19). MATERIALS AND METHODS: In this retrospective single-center study, computed tomography (CT) and MRI scans of 20 patients with COVID-19 pneumonia were evaluated with regard to the distribution, opacity, and appearance of pulmonary lesions, as well as bronchial changes, pleural effusion, and thoracic lymphadenopathy. McNemar's test was used in order to compare the COVID-19-associated alterations seen on CT with those seen on MRI. RESULTS: Ground-glass opacities were better visualized on CT than on MRI (p = 0.031). We found no statistically significant differences between CT and MRI regarding the visualization/characterization of the following: consolidations; interlobular/intralobular septal thickening; the distribution or appearance of pulmonary abnormalities; bronchial pathologies; pleural effusion; and thoracic lymphadenopathy. CONCLUSION: Pulmonary abnormalities caused by COVID-19 pneumonia can be detected on TrueFISP MRI sequences and correspond to the patterns known from CT. Especially during the current pandemic, the portions of the lungs imaged on cardiac or abdominal MRI should be carefully evaluated to promote the identification and isolation of unexpected cases of COVID-19, thereby curbing further spread of the disease.

OBJETIVO: Avaliar o desempenho da ressonância magnética (RM) de 1,5 T true fast imaging with steady state precession (TrueFISP) para detecção e caracterização de anormalidades pulmonares causadas por doença do coronavírus 2019 (COVID-19). MATERIAIS E MÉTODOS: Neste estudo retrospectivo unicêntrico, imagens de tomografia computadorizada (TC) e RM de 20 pacientes com pneumonia COVID-19 foram avaliadas em relação a distribuição, opacidade e forma das lesões pulmonares, anormalidades brônquicas, derrame pleural e linfadenopatia torácica. O teste de McNemar foi usado para comparar os achados associados à COVID-19 na TC e na RM. RESULTADOS: As opacidades em vidro fosco foram mais bem visualizadas na TC do que na RM (p = 0,031). Não foram encontradas diferenças estatisticamente significantes entre TC e RM em relação aos outros aspectos, ou seja, visualização de consolidações e espessamento septal interlobular/intralobular, distribuição ou forma de anormalidades pulmonares, doenças brônquicas, derrame pleural ou linfadenopatia torácica. CONCLUSÃO: As anomalias pulmonares causadas pela pneumonia por COVID-19 podem ser detectadas nas sequências TrueFISP e correspondem aos padrões conhecidos da TC. Especialmente em face da pandemia atual, as porções de imagem dos pulmões na RM cardíaca ou abdominal devem ser cuidadosamente avaliadas para apoiar a identificação e o isolamento de casos inesperados de COVID-19 e, assim, conter a disseminação.