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- Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysisPublication . Gates, Allison; Caldwell, Patrina; Curtis, Sarah; Dans, Leonila; Fernandes, Ricardo M.; Hartling, Lisa; Kelly, Lauren E.; Vandermeer, Ben; Williams, Katrina; Woolfall, Kerry; Dyson, Michele P.Objectives: For 300 paediatric trials, we evaluated the reporting of: a data monitoring committee (DMC); interim analyses, stopping rules and early stopping; and adverse events and harm-related endpoints. Methods: For this cross-sectional evaluation, we randomly selected 300 paediatric trials published in 2012 from the Cochrane Central Register of Controlled Trials. We collected data on the reporting of a DMC; interim analyses, stopping rules and early stopping; and adverse events and harm-related endpoints. We reported the findings descriptively and stratified by trial characteristics. Results: Eighty-five (28%) of the trials investigated drugs, and 18% (n=55/300) reported a DMC. The reporting of a DMC was more common among multicentre than single centre trials (n=41/132, 31% vs n=14/139, 10%, p<0.001) and industry-sponsored trials compared with those sponsored by other sources (n=16/50, 32% vs n=39/250, 16%, p=0.009). Trials that reported a DMC enrolled more participants than those that did not (median [range]): 224 (10-60480) vs 91 (10-9528) (p<0.001). Only 25% of these trials reported interim analyses, and 42% reported stopping rules. Less than half (n=143/300, 48%) of trials reported on adverse events, and 72% (n=215/300) reported on harm-related endpoints. Trials that reported a DMC compared with those that did not were more likely to report adverse events (n=43/55, 78% vs 100/245, 41%, p<0.001) and harm-related endpoints (n=52/55, 95% vs. 163/245, 67%, p<0.001). Only 32% of drug trials reported a DMC; 18% and 19% did not report on adverse events or harm-related endpoints, respectively. Conclusions: The reporting of a DMC was infrequent, even among drug trials. Few trials reported stopping rules or interim analyses. Reporting of adverse events and harm-related endpoints was suboptimal.
- Social media for the dissemination of Cochrane child health evidence: evaluation studyPublication . Dyson, Michele P.; Newton, Amanda S.; Shave, Kassi; Featherstone, Robin M.; Thomson, Denise; Wingert, Aireen; Fernandes, Ricardo M.; Hartling, LisaBackground: Health care providers value ready access to reliable synthesized information to support point-of-care decision making. Web-based communities, facilitated by the adoption of social media tools such as Facebook, Twitter, and YouTube, are increasingly being used for knowledge dissemination, bridging the gap between knowledge generation and synthesis and knowledge implementation. Objective: Our objective was to implement and evaluate a structured social media strategy, using multiple platforms, to disseminate Cochrane Child Health evidence to health care providers caring for children. Methods: Our social media strategy had three components: daily "tweets" using the Cochrane Child Health Twitter account, weekly WordPress blog posts, and a monthly journal club on Twitter ("tweet chat"). Each tweet, blog, and journal club shared Cochrane evidence on a child health topic. We evaluated the strategy through (1) Twitter and blog site analytics, (2) traceable link (Bitly) statistics, (3) Altmetric.com scores for promoted evidence, and (4) participant feedback. We also tracked the resources required to write the blog, tweet content, and manage the strategy. Results: The 22-week social media strategy ran between November 2014 and April 2015. We created 25 blog posts, sent 585 tweets, and hosted 3 tweet chats. Monthly blog visits and views and Twitter account followers increased over time. During the study period, the blog received 2555 visitors and 3967 page views from a geographically diverse audience of health care providers, academics, and health care organizations. In total, 183 traceable Bitly links received 3463 clicks, and the Twitter account gained 469 new followers. The most visited and viewed blog posts included gastrointestinal topics (lactose avoidance), research on respiratory conditions (honey for cough and treatments for asthma), and maternal newborn care (skin-to-skin contact). On Twitter, popular topics were related to public health (vaccination) and pain management. We collected Altmetric.com scores for 61 studies promoted during the study period and recorded an average increase of 11 points. Research staff (n=3) contributed approximately 433 hours to promotion activities and planning (6.5 hours each per week) to implement the social media strategy, and study investigators reviewed all content (blog posts and tweets). Conclusions: This study provides empirical evidence on the use of a coordinated social media strategy for the dissemination of evidence to professionals providing health services to children and youth. The results and lessons learned from our study provide guidance for future knowledge dissemination activities using social media tools.
- COVID-19 and the mental health of children with respiratory illnessPublication . Sinha, Ian P.; Murphy, Ruth; Biffin, Holly; Gait, Lucy; Abrams, Elissa M.; Lee, Alice R.; Gray-ffrench, Madeleine; Fernandes, Ricardo M.; Watson, Edward; Hawcut, Daniel B.; Southern, Kevin W.; Brown, AlexandraChildren and young people have been deeply affected by the COVID-19 pandemic. Lockdowns and new ways of living have necessitated massive adjustments. Despite heroic efforts from teachers, there has been a huge impact on education, and children lost the psychosocial benefits of being in school. News coverage is incessant, and polarised narratives and opinions are amplified in social media echo-chambers. In this report, co-authored with an adolescent from our clinic, we discuss the psychological impact of the COVID-19 pandemic on children and young people with respiratory problems.
- Hospital admissions in children with acute respiratory disease in PortugalPublication . Borges, Joana; Rosa, Matilde; Fernandes, Ricardo M.; Nogueira, P. J.; Bandeira, Teresa
- Quality and risk of bias appraisals of systematic reviews are inconsistent across reviewers and centersPublication . Gates, Michelle; Gates, Allison; Duarte, Gonçalo Silva; Cary, Maria; Becker, Monika; Prediger, Barbara; Vandermeer, Ben; Fernandes, Ricardo M.; Pieper, Dawid; Hartling, LisaObjective: The objective of the study was to evaluate the inter-rater and intercenter reliability, usability, and utility of A MeaSurement Tool to Assess systematic Reviews (AMSTAR), AMSTAR 2, and Risk Of Bias In Systematic reviews (ROBIS). Study design and setting: This is a prospective evaluation using 30 systematic reviews of randomized trials, undertaken at three international centers. Results: Reviewers completed AMSTAR, AMSTAR 2, and ROBIS in median (interquartile range) 15.7 (11.3), 19.7 (12.1), and 28.7 (17.4) minutes and reached consensus in 2.6 (3.2), 4.6 (5.3), and 10.9 (10.8) minutes, respectively. Across all centers, inter-rater reliability was substantial to almost perfect for 8/11 AMSTAR, 9/16 AMSTAR 2, and 12/24 ROBIS items. Intercenter reliability was substantial to almost perfect for 6/11 AMSTAR, 12/16 AMSTAR 2, and 7/24 ROBIS items. Intercenter reliability for confidence in the results of the review or overall risk of bias was moderate (Gwet's first-order agreement coefficient (AC1) 0.58, 95% confidence intervals [CI]: 0.30 to 0.85) to substantial (AC1 0.74, 95% CI: 0.30 to 0.85) for AMSTAR 2 and poor (AC1 -0.21, 95% CI: -0.55 to 0.13) to moderate (AC1 0.56, 95% CI: 0.30 to 0.83) for ROBIS. It is not clear whether using the appraisals of any tool as an inclusion criterion would alter an overview's findings. Conclusions: Improved guidance may be needed to facilitate the consistent interpretation and application of the newer tools (especially ROBIS).
- Modified triple Kessler with least risk of elongation among Achilles tendon repair techniques : a systematic review and network meta-analysis of human cadaveric studiesPublication . Diniz, Pedro; Pacheco, Jácome; Fernandes, Ricardo M.; Pereira, Hélder; Ferreira, Frederico Castelo; Kerkhoffs, Gino M. M. J.Purpose: Current treatment recommendations emphasize early loading, with preservation of tendon length and physiologic tension. The objective of this systematic review and network meta-analysis was to compare failure load and elongation after cyclic loading of Achilles tendon repair techniques at time-zero. Methods: The databases PubMed, CENTRAL and Web of Science were searched for all published in-vitro studies comparing Achilles tendon repair techniques, or augmentation with autografts/biomaterials, and reports of failure load or elongation after cyclic loading. Only studies using human cadaveric Achilles tendons and matched pairs, or randomized specimen allocation, were selected for quantitative synthesis. A network meta-analysis per primary outcome was performed. Results were summarized as P score rankings and their validity was assessed using statistical methods. Results: Sixteen studies, comprising 367 tendon repairs, were included. The following repair techniques were used (n = number of studies): Krackow (n = 8), Achillon (n = 4), double Krackow (n = 3), Bunnell (n = 3), Percutaneous Achilles Repair System (n = 3), Percutaneous Achilles Repair System Midsubstance (n = 2), Kessler (n = 3), double Kessler (n = 1), modified triple Kessler (n = 1), triple bundle (n = 1), a multifilament stainless steel cable-crimp technique (n = 1) and a double loop knot stitch (n = 1). Five studies assessed augmentation with autografts/biomaterials. Regarding the failure load, biomaterial augmented Krackow repairs occupied the first four positions in the ranking, followed by the multifilament stainless steel cable-crimp and Percutaneous Achilles Repair System Midsubstance techniques. Concerning elongation after cyclic loading, the triple Kessler was ranked first, followed by the Achillon and Percutaneous Achilles Repair System Midsubstance techniques. A negligible correlation between ranks was found (rs = 0.11; p = 0.75n.s.), meaning that a higher repair tensile strength is not necessarily related to improved performance in regard to avoidance of elongation. Conclusion: In the failure load network meta-analysis, biomaterial augmented Krackow repairs ranked highest, but noticeable statistical heterogeneity was found. Regarding elongation with cyclic loading, the modified triple Kessler stitch showed the highest probability of ranking first.
- Circulating tumor cell detection methods in renal cell carcinoma : a systematic reviewPublication . Palmela Leitão, Tito; Miranda, Miguel; Polido, Joana; Morais, João; Corredeira, Patrícia; Alves, Patrícia; Ribeiro-de-Oliveira, Tiago; Pereira E Silva, Ricardo; Fernandes, Ricardo M.; Ferreira, João; Reis, José Palma; Lopes, Tomé; Costa, LuisCirculating tumor cells (CTCs) have a potential role as the missing renal cell carcinoma (RCC) biomarker. However, the available evidence is limited, and detection methods lack standardization, hindering clinical use. We performed a systematic review on CTC enrichment and detection methods, and its role as a biomarker in RCC. Full-text screening identified 54 studies. Reviewed studies showed wide heterogeneity, low evidence level, and high risk of bias. Various CTC detection platforms and molecular markers have been used, but none has proven to be superior. CTC detection and CTC count seem to correlate with staging and survival outcomes, although evidence is inconsistent. CTC research is still in an exploratory phase, particularly in RCC. Further studies are still necessary to achieve a standardization of techniques, molecular markers, CTC definitions, and terminology. This is essential to ascertain the role of CTCs as a biomarker and guide future liquid biopsy research in RCC.
- Warfarin, acetylsalicylic acid and risk of incident atrial fibrillation in patients with heart failure and sinus rhythm : a meta-analysisPublication . Caldeira, Daniel; Fernandes, Ricardo M.; David, Cláudio; Costa, João; Ferreira, Joaquim J
- Satisfaction of patients with nonvitamin K anticoagulants compared to vitamin K antagonists : a systematic review and meta-analysisPublication . Katerenchuk, Vasyl; Duarte, Gonçalo Silva; Martins E Pereira, Gonçalo; Fernandes, Ricardo M.; Ferreira, Joaquim J; Pinto, Fausto J.; Costa, João; Caldeira, DanielOBJECTIVE: To undertake a systematic review and meta-analysis to assess the satisfaction of patients receiving nonvitamin K anticoagulants (NOACs), compared with vitamin K antagonists (VKAs). METHODS: We searched CENTRAL, MEDLINE, Embase, and Clinicaltrials.gov for randomized controlled trials (RCTs) and observational studies. Two reviewers screened, extracted, and appraised data independently. We pooled data using a random-effects model. Outcome included treatment satisfaction, which was assessed by scores of Duke Anticoagulation Satisfaction Scale (DASS), Anticlot Treatment Scale (ACTS), Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2), or Treatment Satisfaction Questionnaire for Medication version II (TSQM-VII) and their domains reported with 95% confidence intervals (95% CIs). We followed MOOSE and PRISMA guidelines. RESULTS: We included four RCTs and 16 observational studies, enrolling 18,684 participants overall. Compared with VKAs, treatment with NOACs improved the ACTS Burdens score by 4.21 points (95% CI: 2.99-5.43, I 2 = 95%, combined n = 6,180), and ACTS Benefits by 0.49 points (95% CI: 0.18-0.81, I 2 = 85%, combined n = 6,171). Switching from VKAs to NOACs improved the ACTS Burdens score by 5.33 points (95% CI: 3.53-7.14, combined n = 3,097). Compared with VKAs, treatment with NOACs improved the TSQM-VII Global Satisfaction score by 6.86 points (95% CI: 3.00-10.73, combined n = 5,535). CONCLUSION: In patients with nonvalvular atrial fibrillation or venous thromboembolism, NOAC treatment is associated with greater satisfaction compared with VKAs. The switch from VKAs to NOACs was associated with improved patients’ satisfaction. These effects were largely due to a lower degree of treatment burden with NOAC treatment.
- COVID-19 in children : what did we learn from the first wave?Publication . Bogiatzopoulou, Aliki; Mayberry, Huw; Hawcutt, Daniel B.; Whittaker, Elizabeth; Munro, Alasdair; Roland, Damian; Simba, Justus; Gale, Christopher; Felsenstein, Susanna; Abrams, Elissa; Jones, Caroline B.; Lewins, Ian; Rodriguez-Martinez, Carlos R.; Fernandes, Ricardo M.; Stilwell, Philippa A.; Swann, Olivia; Bhopal, Sunil; Sinha, Ian; Harwood, RachelA pandemic caused by the novel coronavirus, severe acute respiratory syndrome - coronavirus 2 (SARS-CoV-2), has caused high rates of mortality, predominantly in adults. Children are significantly less affected by SARS-CoV-2 with far lower rates of recorded infections in children compared to adults, milder symptoms in the majority of children and very low mortality rates. A suspected late manifestation of the disease, paediatric inflammatory multisystem syndrome - temporally associated with SARS-CoV-2 (PIMS-TS), has been seen in small numbers of children and has a more severe disease course than acute SARS-CoV-2. The pandemic has meant that children around the world have been kept off school, isolated from their extended family and friends and asked to stay inside. The UK has been declared as being in an economic recession and unemployment rates are increasing. These indirect effects of SARS-CoV-2 are likely to have a significant impact on many children for years to come. Consolidating the knowledge that has accumulated during the first wave of this pandemic is essential for recognising the clinical signs, symptoms and effective treatment strategies for children; identifying children who may be at increased risk of severe SARS-CoV-2 infection; planning the safe delivery of healthcare and non-health related services that are important for childrens' wellbeing; and engaging in, and developing, research to address the things that are not yet known. This article summarises the evidence that has emerged from the early phase of the pandemic and offers an overview for those looking after children or planning services.