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Medicine

Introduction Evidence-based recommendations for paediatric community-acquired pneumonia (CAP) diagnosis and management are needed. Uncomplicated CAP is often caused by respiratory viruses, especially in younger children; these episodes self-resolve without antibiotic treatment. Unfortunately, there are no clinical criteria that reliably discriminate between viral and bacterial disease, and so the majority of children diagnosed with CAP are given antibiotics—even though these will often not help and may cause harm. We have developed a novel care pathway that incorporates point-of-care biomarkers, radiographic patterns, microbiological testing and targeted follow-up. The primary study objective is to determine if the care pathway will be associated with less antimicrobial prescribing.Methods and analysis A prospective, before–after, study. Previously well children aged≥6 months presenting to a paediatric emergency department (ED) that have at least one respiratory symptom/sign, receive chest radiography, and are diagnosed with CAP by the ED physician will be eligible. Those with medical comorbidities, recently diagnosed pulmonary infection, or ongoing fever after≥4 days of antimicrobial therapy will be excluded. In the control (before) phase, eligible participants will be managed as per the standard of care. In the intervention (after) phase, eligible participants will be managed as per the novel care pathway. The primary outcome will be the proportion of participants in each phase who receive antimicrobial treatment for CAP. The secondary outcomes include: clinical cure; re-presentation to the ED; hospitalisation; time to resolution of symptoms; drug adverse events; caregiver satisfaction; child absenteeism from daycare/school; and caregiver absenteeism from work.Ethics and dissemination All study documentation has been approved by the Hamilton Integrated Research Ethics Board and informed consent will be obtained from all participants. Data from this study will be presented at major conferences and published in peer-reviewed publications to facilitate collaborations with networks of clinicians experienced in the dissemination of clinical guidelines.Trial registration number NCT05114161.

Pediatrics and RJ1-570

Objective To identify risk factors for severe disease in children hospitalised for SARS-CoV-2 infection.Design Multicentre retrospective cohort study.Setting 18 hospitals in Canada, Iran and Costa Rica from 1 February 2020 to 31 May 2021.Patients Children

Medicine

Medicine

BackgroundWe previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased; (2) the extent to which nonpublished RCTs can be identified in trial registries; and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs.Methods and findingsWe included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study. Pilot, feasibility, and phase 1 studies were excluded. We extracted trial characteristics from each study protocol and systematically searched for corresponding trial registration (if not reported in the protocol) and full text publications until February 2022. For trial registrations, we searched the (i) World Health Organization: International Clinical Trial Registry Platform (ICTRP); (ii) US National Library of Medicine (ClinicalTrials.gov); (iii) European Union Drug Regulating Authorities Clinical Trials Database (EUCTR); (iv) ISRCTN registry; and (v) Google. For full text publications, we searched PubMed, Google Scholar, and Scopus. We recorded whether RCTs were registered, discontinued (including reason for discontinuation), and published. The reporting quality of RCT protocols was assessed with the 33-item SPIRIT checklist. We used multivariable logistic regression to examine the association between the independent variables protocol reporting quality, planned sample size, type of control (placebo versus other), reporting of any recruitment projection, single-center versus multicenter trials, and industry versus investigator sponsoring, with the 2 dependent variables: (1) publication of RCT results; and (2) trial discontinuation due to poor recruitment. Of the 326 included trials, 19 (6%) were unregistered. Ninety-eight trials (30%) were discontinued prematurely, most often due to poor recruitment (37%; 36/98). One in 5 trials (21%; 70/326) remained unpublished at 10 years follow-up, and 21% of unpublished trials (15/70) were unregistered. Twenty-three of 147 investigator-sponsored trials (16%) reported their results in a trial registry in contrast to 150 of 179 industry-sponsored trials (84%). The median proportion of reported SPIRIT items in included RCT protocols was 69% (interquartile range 61% to 77%). We found no variables associated with trial discontinuation; however, lower reporting quality of trial protocols was associated with nonpublication (odds ratio, 0.71 for each 10% increment in the proportion of SPIRIT items met; 95% confidence interval, 0.55 to 0.92; p = 0.009). Study limitations include that the moderate sample size may have limited the ability of our regression models to identify significant associations.ConclusionsWe have observed that rates of premature trial discontinuation have not changed in the past decade. Nonpublication of RCTs has declined but remains common; 21% of unpublished trials could not be identified in registries. Only 16% of investigator-sponsored trials reported results in a trial registry. Higher reporting quality of RCT protocols was associated with publication of results. Further efforts from all stakeholders are needed to improve efficiency and transparency of clinical research.

desk bikes, active workstations, phonological working memory, ADHD, adolescents, Education (General), and L7-991

We investigated the effects of active workstations on cognitive control functions in individuals diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). In a fully counterbalanced randomized control design, we examined the effects of cycling on a desk bike on phonological working memory (WM) in 18 adolescents with ADHD. Adolescents performed a phonological WM test across two separate sessions during which they either cycled or not. It was hypothesized that participants would perform better on the WM task while cycling as compared to seated-rest. Results showed that total WM performance was not affected by desk-bike cycling. Exploratory analyses suggested that cycling during more difficult trials (i.e., high WM demands) is beneficial for WM performance. More research is needed to shed light on how task difficulty moderates the potential compensatory effect of desk-bike cycling on WM performance in adolescent ADHD participants.

cognitive load, measurement methodology, subjective rating scales, visualization, problem solving, Education (General), and L7-991

Cognitive load researchers have used varying subjective techniques based on rating scales to quantify experienced cognitive load. Although it is generally assumed that subjects can introspect on their cognitive processes and have no difficulty in assigning numerical values to the imposed cognitive load, little is known about how visual characteristics of the rating scales influence the validity of the cognitive load measure. In this study we look at validity of four subjective rating scales (within groups) differing in visual appearance by participants rating perceived difficulty and invested mental effort in response to working on simple and complex weekday problems. We used two numerical scales (the nine-point Likert scale most often used in Cognitive load theory research and a Visual Analogue Scale ranging between 0–100%) and two pictorial scales (a scale consisting of emoticons ranging from a relaxed blue-colored face to a stressed red-colored face and an “embodied” scale picturing nine depicted weights from 1–9 kg). Results suggest that numerical scales better reflect cognitive processes underlying complex problem solving while pictorial scales Underlying simple problem solving. This study adds to the discussion on the challenges to quantify cognitive load through various measurement methods and whether subtleties in measurements could influence research findings.

Randomized clinical trials, Trial protocol, Reporting quality, Reporting guideline adherence, Registration, Trial discontinuation, Medicine (General), and R5-920

Abstract Background Clearly structured and comprehensive protocols are an essential component to ensure safety of participants, data validity, successful conduct, and credibility of results of randomized clinical trials (RCTs). Funding agencies, research ethics committees (RECs), regulatory agencies, medical journals, systematic reviewers, and other stakeholders rely on protocols to appraise the conduct and reporting of RCTs. In response to evidence of poor protocol quality, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline was published in 2013 to improve the accuracy and completeness of clinical trial protocols. The impact of these recommendations on protocol completeness and associations between protocol completeness and successful RCT conduct and publication remain uncertain. Objectives and methods Aims of the Adherence to SPIrit REcommendations (ASPIRE) study are to investigate adherence to SPIRIT checklist items of RCT protocols approved by RECs in the UK, Switzerland, Germany, and Canada before (2012) and after (2016) the publication of the SPIRIT guidelines; determine protocol features associated with non-adherence to SPIRIT checklist items; and assess potential differences in adherence across countries. We assembled an international cohort of RCTs based on 450 protocols approved in 2012 and 402 protocols approved in 2016 by RECs in Switzerland, the UK, Germany, and Canada. We will extract data on RCT characteristics and adherence to SPIRIT for all included protocols. We will use multivariable regression models to investigate temporal changes in SPIRIT adherence, differences across countries, and associations between SPIRIT adherence of protocols with RCT registration, completion, and publication of results. We plan substudies to examine the registration, premature discontinuation, and non-publication of RCTs; the use of patient-reported outcomes in RCT protocols; SPIRIT adherence of RCT protocols with non-regulated interventions; the planning of RCT subgroup analyses; and the use of routinely collected data for RCTs. Discussion The ASPIRE study and associated substudies will provide important information on the impact of measures to improve the reporting of RCT protocols and on multiple aspects of RCT design, trial registration, premature discontinuation, and non-publication of RCTs observing potential changes over time.

IRON chelates, VENDOR-managed inventory, SUPPLY chains, THALASSEMIA, and INVENTORY control

Iron chelating therapy (ICT) drugs are prescribed to transfusion dependent thalassaemia (TDT) patients to prevent iron overload complications. The high number of TDT patients in Malaysia strained the public healthcare resources. This paper aims to provide an insight on existing supply chain management of ICT medicines in Malaysia and to explore ways for a more efficient system. A rapid review of literatures was conducted in electronic databases (PubMed, Emerald, Scopus and ScienceDirect) and other relevant Malaysian government documents. Supply of ICT to thalassaemia patients is publicly funded but much availability of oral ICT is restricted due to financial consideration. ICT in Malaysia is supplied through central procurement but purchasing and inventory management are decentralised to each hospital. Vendor-managed inventory system is an ideal option to the inventory management practice in Malaysian public healthcare facilities as it could provide better efficiency and reduces inventory management costs. [ABSTRACT FROM AUTHOR]