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- A critique of the fragility indexPublication . Machado, Tiago; Duarte, Gonçalo Silva; Gonçalves, Nilza C.; Ferreira, Joaquim J.; Costa, JoãoIn The Lancet Oncology , Joseph Del Paggio and Ian Tannock report on a retrospective analysis of the fragility indices of phase 3 trials used by the US Food and Drug Administration (FDA) to approve anticancer drugs. 1 The authors conclude that “many phase 3 randomised controlled trials supporting FDA-approved anticancer drugs have a low fragility index, challenging confidence for concluding their superiority over control treatments.” Although this interpretation is interesting, we would like to draw attention to several points.
- Incidence and prevalence of thoracic aortic aneurysms: a systematic review and meta-analysis of population-based studiesPublication . Melo, Ryan; Duarte, Gonçalo Silva; Lopes, Alice; Alves, Mariana; Caldeira, Daniel; Fernandes E Fernandes, Ruy; Pedro, Luís MThoracic aortic aneurysms (TAA) may grow asymptomatically until they rupture, with a mortality over 90%. The true incidence and prevalence of this condition is uncertain and epidemiologic data is scarce, understudied and dispersed. Therefore, we aimed to conduct a systematic review and meta-analysis of the incidence and prevalence of TAAs in population-based studies. We searched MEDLINE, EMBASE and CENTRAL from inception to October 2020 for all population-based studies reporting on incidence and/or prevalence of TAAs. Data were pooled using a random effects model. The main outcome was the overall available worldwide incidence and prevalence of TAAs. The secondary outcomes were to evaluate the incidence of ruptured TAAs, differences in the location of these aneurysms (either ascending, arch or descending aorta) and differences in prevalence/incidence across different study designs. Twenty-two studies were included in the review and meta-analysis. The pooled incidence and prevalence of TAAs was 5.3 per 100,000 individuals/year (95% confidence interval [CI]: 3.0; 8.3) and 0.16% (95% CI: 0.12; 0.20), respectively. The pooled incidence of ruptured aneurysms was 1.6 per 100,000 individuals/year (95% CI: 1.3; 2.1). We found a significant difference of the prevalence in autopsy-only studies, which was 0.76% (95% CI: 0.47; 1.13) and the prevalence of TAAs dropped down to 0.07% (95% CI: 0.05;0.11) when these studies were excluded from the overall analysis. The current epidemiologic information provided serve as a base for future public-health decisions. The lack of well-design population-base studies and the limitations encountered serve as calling for future research in this field.
- Synchronous and metachronous thoracic aortic aneurysms in patients with abdominal aortic aneurysms : a systematic review and meta‐analysisPublication . Melo, Ryan; Duarte, Gonçalo Silva; Lopes, Alice; Alves, Mariana; Caldeira, Daniel; Fernandes, Ruy Fernandes e; Pedro, Luís MBackground: The prevalence of thoracic aortic aneurysms (TAA) in patients with known abdominal aortic aneurysms (AAA) is not well known and understudied. Our aim was to conduct a systematic review and meta‐analysis of the overall prevalence of synchronous and metachronous TAA (SM‐TAA) in patients with a known AAA and to understand the characteristics of this sub‐population. Methods and Results: We searched MEDLINE, EMBASE, and CENTRAL (Cochrane Central Register of Controlled Trials) from inception to November 2019 for all population‐based studies reporting on the prevalence of SM‐TAAs in a cohort of patients with AAA. Article screening and data extraction were performed by 2 authors and data were pooled using a random‐effects model of proportions using Freeman‐Tukey double arcsine transformation. The main outcome was the prevalence of SM‐TAAs in patients with AAAs. Secondary outcomes were the prevalence of synchronous TAAs, metachronous TAAs, prevalence of TAAs in patients with AAA according to the anatomic location (ascending, arch, and descending) and the differences in prevalence of these aneurysms according to sex and risk factors. Six studies were included. The pooled‐prevalence of SM‐TAA in AAA patients was 19.2% (95% CI, 12.3–27.3). Results revealed that 15.2% (95% CI, 7.1–25.6) of men and 30.7% (95% CI, 25.2–36.5) of women with AAA had an SM‐TAA. Women with AAA had a 2‐fold increased risk of having an SM‐TAA than men (relative risk [RRs], 2.16; 95% CI, 1.32–3.55). Diabetes mellitus was associated with a 43% decreased risk of having SM‐TAA (RRs, 0.57; 95% CI, 0.41–0.80). Conclusions: Since a fifth of AAA patients will have an SM‐TAA, routine screening of SM‐TAA and their clinical impact should be more thoroughly studied in patients with known AAA.
- 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).
- Cardiovascular events reported in randomized controlled trials in restless legs syndromePublication . Duarte, Gonçalo Silva; Alves, Mariana; Silva, Maria A.; Câmara, Raquel; Caldeira, Daniel; Ferreira, Joaquim J.Objective: Evaluate the frequency of cardiovascular adverse events reported in randomized controlled trials (RCT) in Restless Leg Syndrome (RLS). 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. The primary outcome was cardiovascular adverse events defined as cardiac diseases, blood pressure abnormalities, syncope, cerebrovascular diseases, thromboembolic events, and sudden death. The pooled estimated prevalence of cardiovascular (CV) adverse events (AE) and respective 95% confidence interval (CI) was determined by using a meta-analysis. Results: In sum, 28 RCT (2515 participants in the placebo arm and 4223 participants in the intervention arm) reported CV AE. The pooled estimated prevalence of CV AE was 0.61% (95% CI 0.31 to 0.91; I2 ¼ 0%) in the placebo arm and 0.68% (95%CI 0.40 to 0.96; I2 ¼ 18.25%) in the intervention arm. The frequency of major CV events (myocardial infarction, stroke and peripheral artery disease) was 0.49% (95%CI 0.22 to 0.77; I2 ¼ 0%) and 0.33% (95% CI 0.16 to 0.50; I2 ¼ 0%) in the placebo and intervention arm, respectively. Conclusions: The frequency of major cardiovascular events in the RLS trials is not negligible, particularly when considering the young age of these patients.
- 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.
- Prognostic value of phrenic nerve conduction study in amyotrophic lateral sclerosis : systematic review and meta-analysisPublication . Silva, Cláudia; Rodrigues, Filipe Brogueira; Duarte, Gonçalo Silva; Costa, João; Carvalho, MamedeObjectives: To assess the prognostic value of phrenic nerve conduction (PNC) in amyotrophic lateral sclerosis (ALS). Methods: We conducted a systematic review to identify studies reporting on PNC, and mortality and/or forced vital capacity (FVC) in patients with ALS. We searched Medline, EMBASE, and Web of Science. Two independent authors selected studies and extracted data. Risk of bias was assessed using the QUIPS tool. Hazard-ratios and correlation coefficients were pooled using a random effects generic inverse-variance model. Evidence quality was evaluated with GRADE. Results: In the pooled analysis, patients with CMAP-amplitude equal or below 0.4 mV are 2.021 more likely to die over the studied period (95%CI 1.161–3.522; I 2 = 55.9%; 338 participants). CMAP-amplitude showed a moderate positive correlation with FVC (r = 0.400, 95%CI = 0.226–0.550; I 2 = 69.77%; 381 participants). However, there was a weak negative correlation between CMAP-latency and FVC (r = 0.235; 95%CI = 0.447 to 0.024; I 2 = 15.92%; 112 participants). Conclusions: There is moderate-quality evidence that CMAP-amplitude of the PNC is correlated with FVC. Results favour a predictive value for mortality, but the risk of bias is high. Significance: PNC is a simple test that should be considered to assess respiratory function in ALS, especially in patients with bulbar involvement or cognitive impairment.
- Tetrabenazine versus deutetrabenazine for Huntington's disease : twins or distant cousins?Publication . Rodrigues, Filipe Brogueira; Duarte, Gonçalo Silva; Costa, João; Ferreira, Joaquim J; Wild, Edward J.Background: Tetrabenazine is the only US Food and Drug Administration‐approved drug for Huntington's disease, and deutetrabenazine was recently tested against placebo. A switching‐trial from tetrabenazine to deutetrabenazine is underway, but no head‐to‐head, blinded, randomized controlled trial is planned. Using meta‐analytical methodology, the authors compared these molecules. Methods: RCTs comparing tetrabenazine or deutetrabenazine with placebo in Huntington's disease were searched. The authors assessed the Cochrane risk‐of‐bias tool, calculated indirect treatment comparisons, and applied the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. Results: The evidence network for this report comprised 1 tetrabenazine trial and 1 deutetrabenazine trial, both against placebo. Risk of bias was moderate in both. Participants in the tetrabenazine and deutetrabenazine trials did not differ significantly on motor scores or adverse events. Depression and somnolence scales significantly favored deutetrabenazine. Conclusion: There is low‐quality evidence that tetrabenazine and deutetrabenazine do not differ in efficacy or safety. It is important to note that these results are likely to remain the only head‐to‐head comparison between these 2 compounds in Huntington's disease.
- 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.
- Morphine in acute coronary syndrome : systematic review and meta-analysisPublication . Duarte, Gonçalo Silva; Nunes-Ferreira, Afonso; Rodrigues, Filipe Brogueira; Pinto, Fausto J.; Ferreira, Joaquim J.; Costa, João; Caldeira, DanielObjective: Morphine is frequently used in acute coronary syndrome (ACS) due to its analgesic effect, it being recommended in the main cardiology guidelines in Europe and the USA. However, controversy exists regarding its routine use due to potential safety concerns. We conducted a systematic review of randomised-controlled trials (RCTs) and observational studies to synthesise the available evidence. Design: Systematic review and meta-analysis. Data sources: CENTRAL, MEDLINE, EMBASE and trial registries. Eligibility criteria for selecting studies: We included RCTs and observational studies evaluating the impact of morphine in cardiovascular outcomes or platelet reactivity measures. Data extraction and synthesis: Data were screened, extracted and appraised by two independent reviewers. The data were pooled results using a random-effects model. Outcomes included in-hospital mortality, major adverse cardiovascular events (MACE), platelet reactivity (using VerifyNow) and bleeding, reported as relative risk (RR) with 95%CI. We assessed the confidence in the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. We followed the Metaanalysis Of Observational Studies in Epidemiology and Preferred Reporting Items for Systematic Reviews and MetaAnalyses guidelines. Results: Five RCTs and 12 observational studies were included, enrolling 69 993 participants. Pooled results showed an increased risk of in-hospital mortality (RR 1.45 [95% CI 1.10 to 1.91], low GRADE confidence), MACE (RR 1.21, 95%CI 1.02 to 1.45) and an increased platelet reactivity at 1 and 2 hours (59.37 platelet reactivity units [PRU], 95%CI 36.04 to 82.71; 68.28 PRU, 95%CI 37.01 to 99.55, high GRADE confidence) associated with morphine. We found no significant difference in the risk of bleeding. We found no differences in subgroup analyses based on study design and ACS subtype. Conclusions: Morphine was associated with an increased risk of in-hospital mortality and MACE but the high risk of bias leads to low result confidence. There is high confidence that morphine decreases the antiplatelet effect of P2Y12 inhibitors.
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