Ricardo M Fernandes

University of Lisbon | UL · Pediatrics & Clinical Pharmacology and Therapeutics Faculty of Medicine

To characterize the magnitude of the placebo response in trials of migraine therapy in children and adolescents, and to identify its determinants. MEDLINE and CENTRAL were searched through November 2006 for randomized controlled trials or controlled clinical trials of pediatric acute migraine pharmacologic treatment that included a placebo comparat...

Objectives: For child health randomized controlled trials (RCTs) published in 2012, we aimed to describe design and reporting characteristics and evaluate changes since 2007; assess the association between trial design and registration and risk of bias (RoB); and assess the association between RoB and effect size. Study design: For 300 RCTs, we...

Background: Overviews of reviews (i.e., overviews) compile information from multiple systematic reviews to provide a single synthesis of relevant evidence for healthcare decision-making. Despite their increasing popularity, there are currently no systematically developed reporting guidelines for overviews. This is problematic because the reporting...

The need for information about new and existing drugs used in children was recognized in the European Union (EU) with the implementation of the Paediatric Regulation in 2007. In 2017, the 10-year review of the Paediatric Regulation identified barriers to the conduct of clinical trials, including delays in setting up and completing paediatric trials...

* Abbreviations: DMC — : data monitoring committee Children are generally regarded as “vulnerable individuals.” There has long been reluctance to perform research in children except in limited settings such as pediatric cancer and vaccine development. However, avoidance of trials in children has resulted in uncertainty regarding efficacy, safety,...

Background/aims Due to a lack of standard pediatric prescribing information, medicines are often used in a dosage form or for an indication that has not been investigated in children. Pediatric clinical trial research networks aim to facilitate the timely availability of innovative drugs for children by developing standardized trial facilitation an...

Background Despite global efforts to improve paediatric clinical trials, significant delays continue in paediatric drug approvals. Collaboration between research networks is needed to address these delays. This paper is a first step to promote interoperability between paediatric networks from different jurisdictions by comparing drivers for, and co...

To identify priority areas to improve the design, conduct, and reporting of pediatric clinical trials, the international expert network, Standards for Research (StaR) in Child Health, was assembled and published the first 6 Standards in Pediatrics in 2012. After a recent review summarizing the 247 publications by StaR Child Health authors that high...

Background Although economic evaluations (EEs) have been increasingly applied to medical devices, little discussion has been conducted on how the different health realities of specific populations may impact the application of methods and the ensuing results. This is particularly relevant for pediatric populations, as most EEs on devices are conduc...

Background Although economic evaluations (EEs) have been increasingly applied to medical devices, little discussion has been conducted on how the different health realities of specific populations may impact the application of methods and the ensuing results. This is particularly relevant for pediatric populations, as most EEs on devices are conduc...

Rationale There is significant practice variation in acute paediatric asthma, particularly severe exacerbations. It is unknown whether this is due to differences in clinical guidelines. Objectives To describe and compare the content and quality of clinical guidelines for the management of acute exacerbations of asthma in children between geographi...

Introduction The high failure rate of industry-driven pediatric clinical trials leads to insufficient timely labeling of drugs in children and a lack of scientific evidence, resulting in the persistently high off-label drug use. National clinical trial networks can facilitate collaboration between sites, investigators, and experts, increasing the l...

Background Despite global efforts to improve paediatric clinical trials, significant delays continue in paediatric drug approvals. Collaboration between research networks is needed to address these delays. This paper is a first step to promote interoperability between paediatric networks from different jurisdictions by comparing drivers for, and co...

Background: Data monitoring committees advise on clinical trial conduct through appraisal of emerging data to ensure participant safety and scientific integrity. While consideration of their use is recommended for trials performed with vulnerable populations, previous research has shown that data monitoring committees are reported infrequently in...

Introduction Between 50 and 96% of drugs prescribed to neonatal and paediatric populations are used off-label, creating a clear need for clinical pharmacology studies and subsequent labelling. Key to the successful future of paediatric drug development is creating a collaborative community of professionals focusing on neonatal/paediatric clinical p...

Background Acute exacerbations of asthma are common in children, however, treatment decisions for severe exacerbations are challenging due to a lack of robust evidence. In order to create more robust research, a core set of outcome measures needs to be developed. In developing these outcomes, it is important to understand the views of clinicians wh...

Setting‐up a high quality, compliant and efficient pharmacovigilance (PV) system in multi‐country clinical trials can be more challenging for academic sponsors than for companies. To ensure the safety of all participants in academic studies and that the PV system fulfils all regulations, we set up a centralized PV system that allows sponsors to del...

Objectives We aimed to evaluate the international variation in the use of evidence-based management (EBM) in bronchiolitis. We hypothesised that management consistent with full-EBM practices is associated with the research network of care, adjusted for patient-level characteristics. Secondary objectives were to determine the association between ful...

Introduction Over the last years, the number of systematic reviews published is steadily increasing due to the global interest in this type of evidence synthesis. However, little is known about the characteristics of this research published in Portuguese medical journals. This study aims to evaluate the publication trends and overall quality of the...

Setting-up a high quality and efficient pharmacovigilance (PV) system in multi-country clinical trials can be more challenging for academic sponsors than for industrials. Generating high-quality safety data, compliant with legal and regulatory standards such as European or World Health Organization (WHO), places special requirements on the PV syste...

Objective To develop a reporting guideline for overviews of reviews of healthcare interventions. Design Development of the preferred reporting items for overviews of reviews (PRIOR) statement. Participants Core team (seven individuals) led day-to-day operations, and an expert advisory group (three individuals) provided methodological advice. A pa...

Background Some patients with chronic coronary syndromes undergo invasive procedures but the efficacy of such interventions remains to be robustly established by randomised sham-controlled trials (RCTs). Purpose To determine the sham effect in patients with chronic coronary syndromes enrolled in RCTs by performing a systematic review and meta-anal...

Children exposed to various indoor and outdoor allergens are placed at an increased risk of developing asthma in later life, with sensitization in these individuals being a strong predictor of disease morbidity. In addition, aeroallergen exposure influences asthma outcomes through an interplay with adverse determinants of health. The goal of this r...

The publication of systematic reviews has rapidly increased making it challenging to remain apprised of and interpret evidence from their growing number. A newer form of evidence synthesis, overview of reviews, synthesizes evidence from multiple systematic reviews. Authors would benefit from evidence- and consensus-based guidance for the complete a...

The Preferred Reporting Items for Overviews of Reviews (PRIOR) statement provides an evidence-based reporting guideline developed using established, rigorous methods that involved a four-stage process (project launch, evidence reviews, modified Delphi exercise, development of the reporting guideline) and an international stakeholder group represent...

Objectives The objective of this study was to develop a core outcome set (COS) for use in future clinical trials in bronchiolitis. We wanted to find out which outcomes are important to healthcare professionals (HCPs) and to parents and which outcomes should be prioritised for use in future clinical trials. Design and setting The study used a syste...

Objective To capture the early effects of the SARS-CoV-2 pandemic on pediatric clinical research. Study design Pediatric clinical research networks from 20 countries and 50 of their affiliated research sites completed two surveys over one month from early May to early June 2020. Networks liaised with their affiliated sites and contributed to the i...

Background: Poor medication adherence is a major challenge in asthma and objective assessment of inhaler adherence is needed. InspirerMundi app aims to monitor inhaler adherence while turning it into a positive experience through gamification and social support. Objective: We assessed the medium-term feasibility of the InspirerMundi app to monitor...

PurposeCurrent 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 We...

Context: Uncertainty exists as to which treatments are most effective for bronchiolitis, with considerable practice variation within and across health care sites. Objective: A network meta-analysis to compare the effectiveness of common treatments for bronchiolitis in children aged ≤2 years. Data sources: Medline, Embase, Cochrane Central Regi...

Circulating 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 id...

Introduction: Over the last years, the number of systematic reviews published is steadily increasing due to the global interest in this type of evidence synthesis. However, little is known about the characteristics of this research published in Portuguese medical journals. This study aims to evaluate the publication trends and overall quality of th...

We aimed to identify persistent asthma phenotypes among adolescents and to evaluate longitudinally asthma-related outcomes across phenotypes. Adolescents (13–17 years) from the prospective, observational, and multicenter INSPIRERS studies, conducted in Portugal and Spain, were included (n = 162). Latent class analysis was applied to demographic, en...

[This corrects the article DOI: 10.1016/j.paed.2020.09.005.].

Aims: To identify distinct asthma control clusters based on Control of Allergic Rhinitis and Asthma Test (CARAT) and to compare patients’ characteristics among these clusters. Methods: Adults and adolescents (≥13 years) with persistent asthma were recruited at 29 Portuguese hospital outpatient clinics, in the context of two observational studies of...

The novel coronavirus disease‐2019 (COVID‐19), caused by the pathogen severe acute respiratory syndrome‐CoV‐2, is causing a global pandemic, with over 26.9 million cases and 880,000 deaths as of September 6, 2020. While there has been speculation and observational research about the impact of COVID‐19 on asthma, much remains unknown. The goal of th...

Fluoroquinolone use has been associated with collagen disease events, raising safety concerns. We hypothesized that the use of fluoroquinolones is associated with aortic aneurysm (AA) and aortic dissection or rupture (AD/AR). We performed a systematic review with meta-analyses on studies published until March 2019. Seven observational studies were...

Objective 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,...

Objective: The objective of the study was to assess the variability in the management of paediatric MHT in European emergency departments (EDs). Methods: This was a multicentre retrospective study of children ≤18 years old with minor head trauma (MHT) (Glasgow Coma Scale ≥14) who presented to 15 European EDs between 1 January 2013 and 31 Decembe...

Background Bronchiolitis is a major cause of admission to hospital in children. Non-invasive ventilation (NIV) support with continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) oxygen is routinely used for infants in the UK with bronchiolitis. Objective To establish UK paediatric practice regarding management of bronchiolit...

During the Covid19 pandemic there has been much discussion about in-hospital procedures that may generate aerosols. One such procedure, that has led to confusion and concern, is nebulisation of children. In this paper, we discuss the evidence around whether nebulisation procedures generate aerosols, and offer strategies around nebulisation of child...

A 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 ve...

Background and objectives: International patterns of antibiotic use and laboratory testing in bronchiolitis in emergency departments are unknown. Our objective is to evaluate variation in the use of antibiotics and nonindicated tests in infants with bronchiolitis in 38 emergency departments in Pediatric Emergency Research Networks in Canada, the U...

Objective: To evaluate the interrater and inter-centre reliability, usability, and utility of AMSTAR, AMSTAR 2, and ROBIS. Study design and setting: Prospective evaluation using 30 systematic reviews of randomized trials, undertaken at three international centres. Results: Reviewers completed AMSTAR, AMSTAR 2, and ROBIS in median (IQR) 15.7 (1...

The novel severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) pandemic poses a serious threat to public health and local economies around the globe. This has created an urgent need to identify effective medications for its prevention and treatment (1). Among these treatments, the off‐label use of hydroxychloroquine (HCQ), a less toxic deri...

Background: Acute severe childhood asthma is an infrequent, but potentially life-threatening emergency condition. There is a wide range of different approaches to this condition, with very little supporting evidence, leading to significant variation in practice. To improve knowledge in this area, there must first be consensus on how to conduct cli...

Background: Functional mobility (FM) is a person's ability to move to accomplish activities of daily living; it bridges the concepts of mobility and functional ability. There is frequently a loss of FM in Parkinson's disease (PD). Several instruments have been used to assess this concept in PD; however, there is no consensus on which are the most...

Background Clinical guidelines advise against pharmacotherapy in bronchiolitis. However, little is known about global variation in prescribing practices for bronchiolitis at discharge from emergency departments. We aimed to evaluate global variation in prescribing practice (ie, inhaled salbutamol, or oral or inhaled corticosteroids) for infants wit...

Objective We aimed to compare patient's and physician's ratings of inhaled medication adherence and to identify predictors of patient-physician discordance. Design Baseline data from two prospective multicentre observational studies. setting 29 allergy, pulmonology and paediatric secondary care outpatient clinics in Portugal. Participants 395 patie...

Importance Parkinson disease (PD) manifests by motor and nonmotor symptoms, which may be preceded by mood disorders by more than a decade. Bipolar disorder (BD) is characterized by cyclic episodes of depression and mania. It is also suggested that dopamine might be relevant in the pathophysiology of BD. Objective To assess the association of BD wi...

Background. Acute severe childhood asthma is an infrequent, but potentially life-threatening emergency presentation. There is a wide range of different approaches to this condition, with very little supporting evidence, leading to significant variation in practice. To improve knowledge in this area, there must first be consensus on how to conduct c...

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 throu...

IntroductionSpirometry is a key component of the asthma managementguidelines’ workup for diagnosis, assessment and monitoringof severity and control.1However, evidence from practicepattern studies and surveys suggests there is limited use ofspirometry in patients of all ages with asthma,2for reasonsthat remain unclear.3,4In Portugal, the National P...

Background. Acute severe childhood asthma is an infrequent, but potentially life-threatening emergency presentation. There is a wide range of different approaches to this condition, with very little supporting evidence, leading to significant variation in practice. To improve knowledge in this area, there must first be consensus on how to conduct c...

Background: Bronchiolitis is the leading cause of hospital admission for respiratory disease among infants aged <1 year. Clinical practice guidelines can benefit patients by reducing the performance of unnecessary tests, hospital admissions, and treatment with lack of a supportive evidence base. This review aimed to identify current clinical pract...

Objective Adverse events (AEs) associated with short-term corticosteroid use for respiratory conditions in young children. Design Systematic review of primary studies. Data sources Medline, Cochrane CENTRAL, Embase and regulatory agencies were searched September 2014; search was updated in 2017. Eligibility criteria Children <6 years with acute...

In this article, the Group Chairs and early career members of the European Respiratory Society (ERS) Paediatric Assembly highlight some of the most interesting findings in the field of paediatrics which were presented at the 2018 international ERS Congress.

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 C...

Background Overviews of reviews of healthcare interventions (overviews) integrate information from multiple systematic reviews (SRs) to provide a single synthesis of relevant evidence for decision-making. Overviews may identify multiple SRs that examine the same intervention for the same condition and include some, but not all, of the same primary...

Background Overviews of reviews (overviews) compile information from multiple systematic reviews (SRs) to provide a single synthesis of relevant evidence for decision-making. Overviews may identify multiple SRs that examine the same intervention for the same condition and include some, but not all, of the same primary studies. There is currently li...

Background: Bronchiolitis is an acute lower respiratory infection which predominantly affects young children. Treatment for bronchiolitis is limited to supportive therapy. Nasal oxygen therapy is part of routine care, and delivery now incorporates varying levels of non-invasive continuous positive airway pressure and/or high-flow nasal cannula oxy...