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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.
- Hospital admissions in children with acute respiratory disease in PortugalPublication . Borges, Joana; Rosa, Matilde; Fernandes, Ricardo M.; Nogueira, P. J.; Bandeira, Teresa
- 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
- Performance of the HAS-BLED high bleeding-risk category, compared to ATRIA and HEMORR2HAGES in patients with atrial fibrillation : a systematic review and meta-analysisPublication . Caldeira, Daniel; Costa, João; Fernandes, Ricardo M.; Pinto, Fausto J.; Ferreira, Joaquim JIntroduction: Atrial fibrillation (AF) patients’ major bleeding risk should be evaluated through risk scores such as HAS-BLED, HEMORR2HAGES or ATRIA. These scores were validated in independent studies with different methods. Therefore, we aimed to review and estimate the value added by ATRIA and HEMORR2HAGES compared to HAS-BLED. Methods: Medline and Cochrane Library (July 2013) were searched, as well as reviews and references of obtained articles. We looked for studies reporting data for diagnostic accuracy of HAS-BLED with any of HEMORR2HAGES or ATRIA scores, concerning Major Bleeding events. We determined the sensitivity, specificity, and diagnostic odds ratio (DOR) of ATRIA and HEMORR2HAGES compared to HAS-BLED within the same studies. Random effects meta-analysis was performed in order to derive diagnostic accuracy estimates. Heterogeneity was assessed through I 2 test. Results: Six studies fulfilled inclusion criteria. Five studies evaluated simultaneously HAS-BLED and HEMORR2HAGES. Sensitivity, specificity, and DOR were respectively 0.53 (0.52–0.54), 0.65 (0.65–0.65) and 2.11 (1.91–2.35) for HAS-BLED, and 0.27 (0.26–0.27), 0.89 (0.89–0.89) and 2.90 (2.77–3.04) for HEMORR2HAGES. Four studies compared HAS-BLED with ATRIA. Sensitivity, specificity, and DOR were respectively 0.41 (0.35–0.48), 0.78 (0.76–0.79) and 2.22 (1.08–4.55) for HAS-BLED, and 0.23 (0.17–0.29), 0.91 (0.90–0.91) and 1.98 (1.29–3.03) for ATRIA. Conclusions: The ‘high-risk’ categories of the evaluated major bleeding-risk scores are not sensitive. HAS-BLED, due to its sensitivity (compared to other scores) and ease to apply, is recommended for the assessment of AF patients’ major bleeding risk.
- Perceção e atitudes sobre prescrição racional durante a formação médica : resultados de grupos focais com estudantes de medicina e médicos internosPublication . Boaventura, Isabel; Costa, João; Fernandes, Ricardo M.; Ferreira, Joaquim J.Introduction: Clinical pharmacology educational strategies for medicine students seek to foster skills that range from technical knowledge to the development of behaviors that ensure rational prescribing decisions. The authors present the results of a study to evaluate the perceptions, attitudes and behaviors linked with rational prescribing throughout training. Material and Methods: Four focus groups were held with first, third and fifth year medical students and residents from the first years of various specialties, with a total of 29 participants. A semi-structured questionnaire with open-ended questions was used to facilitate interaction between the participants, alongside case-studies to explore the behaviors associated with therapeutic decisions. Results: The analysis of the references showcased an evolution of concepts throughout academic training. References regarding guidelines and effectiveness emerge during the third year; safety and treatment personalization emerge during the fifth year and specialist training. Efficacy studies, systematic reviews, regulatory documents and online platforms were considered the most relevant sources of information. Discussion: The literature review showcases the need to implement strategies dedicated to the development of adequate skills for rational prescribing. The use of focus groups may be a useful methodology to engage students in self-evaluation of their skills and inform faculty of the perceptions and behaviors of students. Conclusion: This analysis illustrates the awareness of students and young physicians to the need to adapt therapeutic approaches to the characteristics of the patient. These concepts should be reinforced so that young doctors feel more prepared for rational prescription in complex clinical situations.
- Placebo and nocebo responses in restless legs syndrome : a systematic review and meta-analysisPublication . Silva, Maria A.; Duarte, Gonçalo Silva; Camara, Raquel; Rodrigues, Filipe Brogueira; Fernandes, Ricardo M.; Abreu, Daisy; Mestre, Tiago; Costa, João; Trenkwalder, Claudia; Ferreira, Joaquim JObjective: To estimate the placebo and nocebo responses in restless legs syndrome (RLS) and explore their determinants. Methods: Databases were searched up to October 2015. Randomized, double-blind, placebo-controlled trials of patients with RLS were included if quantitative data were extractable in the placebo arm. Placebo response was defined as the within-group change from baseline, using any scale measuring RLS severity or disability. Nocebo response was defined as the proportion of patients experiencing adverse events in the placebo arm. Random-effects meta-analysis was used to pool data. Statistical heterogeneity was assessed with I2 statistic. Several predetermined subgroup and sensitivity analysis were performed. PROSPERO registration number is CRD42015027992. Results: We included 85 randomized controlled trials (5,046 participants). Pooled placebo response effect size was −1.41 (95% confidence interval [CI] −1.56 to −1.25, 64 trials, I2 = 88.1%), corresponding to −6.58 points in the International RLS Study Group Scale (IRLS). Pooled nocebo response was 45.36% (95% CI 40.47%–50.29%, 72 trials; I2 = 89.8%). The placebo and nocebo responses were greater in trials with longer duration, evaluating pharmacologic interventions and idiopathic RLS, and in industry-funded and unpublished studies. The placebo response was considerably smaller in objective as compared to subjective outcomes. In addition, the nocebo response increases proportionally with the placebo response, and has the same predictors. Conclusions: The magnitude of the placebo response in RLS is above the threshold of minimal clinical important difference, and the frequency of adverse events is also considerable. These results are relevant to inform the design and interpretation of future clinical trials.
- Glucocorticoids for acute viral bronchiolitis in infants and young childrenPublication . Fernandes, Ricardo M.; Bialy, Liza M.; Vandermeer, Ben; Tjosvold, Lisa; Plint, Amy C.; Patel, Hema; Johnson, David W.; Klassen, Terry P.; Hartling, LisaBackground: Previous systematic reviews have not shown clear benefit of glucocorticoids for acute viral bronchiolitis, but their use remains considerable. Recent large trials add substantially to current evidence and suggest novel glucocorticoid-including treatment approaches. Objectives: To review the efficacy and safety of systemic and inhaled glucocorticoids in children with acute viral bronchiolitis. Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2012, Issue 12), MEDLINE (1950 to January week 2, 2013), EMBASE (1980 to January 2013), LILACS (1982 to January 2013), Scopus® (1823 to January 2013) and IRAN MedEx (1998 to November 2009). Selection criteria: Randomised controlled trials (RCTs) comparing short-term systemic or inhaled glucocorticoids versus placebo or another intervention in children under 24 months with acute bronchiolitis (first episode with wheezing). Our primary outcomes were: admissions by days 1 and 7 for outpatient studies; and length of stay (LOS) for inpatient studies. Secondary outcomes included clinical severity parameters, healthcare use, pulmonary function, symptoms, quality of life and harms. Data collection and analysis: Two authors independently extracted data on study and participant characteristics, interventions and outcomes. We assessed risk of bias and graded strength of evidence. We meta-analysed inpatient and outpatient results separately using random-effects models. We pre-specified subgroup analyses, including the combined use of bronchodilators used in a protocol. Main results: We included 17 trials (2596 participants); three had low overall risk of bias. Baseline severity, glucocorticoid schemes, comparators and outcomes were heterogeneous. Glucocorticoids did not significantly reduce outpatient admissions by days 1 and 7 when compared to placebo (pooled risk ratios (RRs) 0.92; 95% confidence interval (CI) 0.78 to 1.08 and 0.86; 95% CI 0.7 to 1.06, respectively). There was no benefit in LOS for inpatients (mean difference -0.18 days; 95% CI -0.39 to 0.04). Unadjusted results from a large factorial low risk of bias RCT found combined high-dose systemic dexamethasone and inhaled epinephrine reduced admissions by day 7 (baseline risk of admission 26%; RR 0.65; 95% CI 0.44 to 0.95; number needed to treat 11; 95% CI 7 to 76), with no differences in short-term adverse effects. No other comparisons showed relevant differences in primary outcomes. Authors' conclusions: Current evidence does not support a clinically relevant effect of systemic or inhaled glucocorticoids on admissions or length of hospitalisation. Combined dexamethasone and epinephrine may reduce outpatient admissions, but results are exploratory and safety data limited. Future research should further assess the efficacy, harms and applicability of combined therapy.
- Terapêutica combinada e alternada com Paracetamol e Ibuprofeno para crianças com febrePublication . Sousa, Rodrigo; Costa, João; Carneiro, António Vaz; Fernandes, Ricardo M.
- Imunoestimulantes na prevenção de infeções respiratórias em criançasPublication . Gil, Joana; Costa, João; Carneiro, António Vaz; Fernandes, Ricardo M.