A systematic review to identify and collate factors influencing patient journeys through clinical trials.

Patient-centred trial design and delivery; improves recruitment and retention; increases participant satisfaction; encourages participation by a more representative cohort; and allows researchers to better meet participants' needs. Research in this area mostly focusses on narrow facets of trial participation. We aimed to systematically identify the breadth of patient-centred factors influencing participation and engagement in trials, and collate them into a framework. Through this we hoped to assist researchers to identify factors that could improve patient-centred trial design and delivery. Robust qualitative and mixed methods systematic reviews are becoming increasingly common in health research. The protocol for this review was prospectively registered on PROSPERO, CRD42020184886. We used the SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, Research Type) framework as a standardised systematic search strategy tool. 3 databases were searched as well as references checking, and thematic synthesis was conducted. Screening agreement was performed and code and theme checking were conducted by 2 independent researchers. Data were drawn from 285 peer-reviewed articles. 300 discrete factors were identified, and sorted into 13 themes and subthemes. The full catalogue of factors is included in the Supplementary Material. A summary framework is included in the body of the article. This paper focusses on outlining common ground that themes share, highlighting critical features, and exploring interesting points from the data. Through this, we hope researchers from multiple specialities may be better able to meet patients' needs, protect patients' psychosocial wellbeing, and optimise trial recruitment and retention, with direct positive impact on research time and cost efficiency.

Clinical and epidemiological characteristics of children with COVID-19 in Selangor, Malaysia.

Objective: To describe the clinical and epidemiological characteristics of children diagnosed with coronavirus disease 2019 (COVID-19) at Hospital Sungai Buloh, Selangor, Malaysia. Methods: A retrospective observational study was performed on children aged <12 years diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection between January 25 and December 31, 2020. A comparative analysis was undertaken between asymptomatic and symptomatic children, as well as a sub-analysis of their caretakers' COVID-19 status. Results: A total of 1498 children were included, 48.7% female and 51.3% male. Their mean age was 5.6 years (standard deviation 3.5 years). Overall, 82.3% were detected through contact tracing of positive family members or from the same household. Fifty-seven percent were asymptomatic. The most common symptoms reported were fever, nasal congestion/rhinorrhoea, and cough. Compared to asymptomatic children, those who were symptomatic had higher reported comorbidities, lower total white blood cell (WBC), absolute lymphocyte, and absolute neutrophil counts, raised C-reactive protein (CRP), and raised aspartate transaminase (P < 0.05). The median duration of illness was 10 days (interquartile range 3 days). Overall outcomes were good. Only 19 (8.2%) negative caretakers seroconverted prior to discharge. Conclusions: The majority of the children in the State of Selangor experienced mild COVID-19 illness in 2020, and they did not appear to be key drivers in the transmission of the disease.

New drug controls and reduced hospital presentations due to novel psychoactive substances in Edinburgh.

AIMS: Recreational use of novel psychoactive substance (NPS) has become increasingly common. We aimed to assess the association of national legislation and local trading standards activity with hospital presentations. METHODS: We established observational cohorts of patients with recreational drug toxicity presenting to Edinburgh Royal Infirmary and dying with detectable recreational drugs in Edinburgh. We assessed associations with two temporary class drug-orders (April 2015: methylphenidates, Nov 2015: methiopropamine), the Psychoactive Substances Act (June 2016), and trading standards forfeiture orders (October 2015). RESULTS: The methylphenidate temporary class drug-order was associated with rapid 46.7% (P = 0.002) and 21.0% (P = 0.003) reductions in presentations and admissions, respectively, for NPS drug toxicity, comparing 12 months before with 6 months after. The change was greatest for ethylphenidate toxicity (96.7% reduction in admissions, P < 0.001) that was partly offset by a tripling in synthetic cannabinoid receptor agonist cases (P < 0.001) over the next 6 months. This increase reversed following trading standards activity removing all NPS drugs from local shops in October 2015, associated with 64.3% (P < 0.001) and 83.7% (P < 0.001) reductions in presentations and admissions, respectively, for all NPS drugs over the next 12 months. The effect was sustained and associated with a reduced postmortem detection of stimulant NPS drugs. The two interventions prevented an estimated 557 (95% confidence interval 327-934) NPS admissions during 2016, saving an estimated £303 030 (£177 901-508 133) in hospital costs. CONCLUSIONS: We show here that drug legislation and trading standards activity may be associated with effective and sustained prevention. Widespread adoption of trading standards enforcement, together with focused legislation, may turn the tide against these highly-damaging drugs.

Prescription patterns of inhaled corticosteroids for preschool children--A Norwegian register study.

BACKGROUND: Although guidelines for treatment of wheeze and asthma in preschool children are available, symptoms are overlapping and it may be difficult to decide which children should be given inhaled corticosteroids (ICS). Previous studies suggest an inappropriate prescription pattern of ICS in this age group. We studied time trends of ICS use in preschool children in Norway during 2004-2013 by age, gender and physician specialty, and the persistence of ICS use during preschool years. METHODS: Data were drawn from the Norwegian Prescription Database. The study population consisted of children ≤5 years who were prescribed ICS (alone or in combination) during 2004-2013. RESULTS: The one-year prevalence of ICS use was generally high, and increased from 2004 to 2010, but decreased thereafter. The prevalence was highest in 2-year-olds (boys 12.9% and girls 9.3% in 2010) and declined by age, and higher among boys in all ages. 40-50% of ICS users received only one prescription per year. The share of children with persistent use of ICS over several preschool years was low, irrespective of the age at the first prescription. The majority of prescriptions were given by general practitioners, increasing during the study period. CONCLUSIONS: The prevalence of ICS prescription for preschool children was high, but with low persistence, suggesting that ICS are frequently given for intermittent asthma-like symptoms. Asthma guidelines suggest a restrictive use of ICS during the first years of life, and the results may call for actions to better implement these guidelines.

Aspectos clínicos e epidemiológicos da insuficiência cardíaca / Clinical and epidemilogical aspects of heart failure

Demonstração dos dados clínicos e epidemiológicos de um pequeno, mas representativo número de pacientes atendidos no ambulatório de Cardiologia do Hospital Universitário da Universidade Federal de Juiz de Fora (HU-CAS-UFJF), portadores de Insuficiência Cardíaca (IC), a fim de traçar um paralelo com os dados obtidos no DATASUS e na literatura mundial. Utilizou-se um questionário para definição das características clínicas: sintomas, classe funcional (CF), sexo, idade, raça, medicamentos em uso, resposta terapêutica e etiologia da IC. Todos os pacientes realizaram eletrocardiograma de repouso (ECG) e ecocardiograma bidimensional com doppler. No período de novembro de 2005 a maio de 2006, 35 pacientes com IC foram avaliados. Houve predominância do sexo masculino (60%), a idade variou de 20 a 87 anos e em 28 pacientes se observou excelente resposta terapêutica (CF I), com 3 pacientes em cada uma das CFs II e III, e apenas 1 na CF IV. O ECG mostrou bloqueio do ramo esquerdo (BRE) em 25,7%, fibrilação atrial (FA) em 20%, sobrecarga atrial esquerda (SAE) em 11,42% e hipertrofia ventricular esquerda (HVE) em 11,42%. O ECG foi normal em 8,57%. A fração de ejeção do ventrículo esquerdo (FEVE) esteve reduzida em 28 pacientes (80%). A etiologia mais frequente foi cardiopatia hipertensiva (40%), seguida de miocardiopatia dilatada idiopática (25,72%) e da cardiopatia isquêmica (14%). A síndrome da IC tem diferentes aspectos epidemiológicos regionais, principalmente, na diversidade etiopatogênica, com aumento progressivo de causa aterogênica à medida que se obtém maior desenvolvimento industrial e urbano.

The aim of this study was to investigate clinical and epidemiological data of a small, albeit representative, sample of patients with heart failure (HF), seen at the Cardiology Unity of the Teaching Hospital of the Federal University of Juiz de Fora. These data were compared to those from the world literature. There was a questionnaire to check the following clinical features: symptoms, functional class, sex, age, ethnicity, drugs in use, therapeutic response and the etiology of HF. All the patients underwent electrocardiography at rest and uni e bidimensional Doppler echocardiography. From November 2005 to May 2006, 35 patients with HF were evaluated. 60% were men (age range: 20-87 years), and 28 had a good response to drugs, being classified in functional class I. Classes II and III had 3 patients each. Only 1 patient was in class IV. ECG revealed left bundle branch block in 25.7% of the patients, atrial fibrillation in 20%, left atrial enlargement in 11.42% and left ventricular enlargement in 11.42%. The ECG was normal in 8.57%. Left ventricular ejection fraction was reduced in 28 patients (80%). The most frequent etiology was hypertensive cardiomyopathy (40%), followed by idiopathic dilated cardiomyopathy (25.72%) and ischemic cardiomyopathy (14%). The Framingham study also showed a high prevalence of hypertensive cardiomyopathy as the cause of heart failure. However, due to better blood pressure control, ischemic disease has been the main cause of heart failure in adults in industrially developed and urban regions.