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Paediatric asthma control under a community management model in China: a protocol for a prospective multicentre cohort study.

ABSTRACT: INTRODUCTION:Childhood asthma is globally one of the most common respiratory disorders and accounts for more school absences and more hospitalizations than any other chronic illness. The worldwide economic burden of this disease exceeds those of HIV/AIDS and tuberculosis combined. Proper intervention and effective management is of paramount importance for the control and prognosis of paediatric asthma. Unfortunately, the rate of uncontrolled and partially controlled paediatric asthma in China is >90%. This study will use a new management model to investigate the status of asthma control and the adherence of patients to a medication protocol. METHODS:This prospective, multicentre, observational study will be conducted at 15 hospitals on children (n=800) diagnosed with asthma. Each patient will be assigned to either the nearest community hospital or Shanghai Children's Medical Center, whichever is closer to the patient's home, according to the decision of parents. Participants were divided into two groups: tertiary care hospital (Shanghai Children's Medical Center) follow-up group and community hospital follow-up group. The primary outcome will be the difference in the proportion of controlled, partially controlled and uncontrolled asthma among the two groups. Secondary outcomes will be the differences in adherence rate, lung function, exacerbations, growth development, total asthma-related unscheduled visits, days absent from school and loss of working days for the patient's caregiver. Data will be analysed on an intention-to-treat and a per-protocol basis. ETHICS AND DISSEMINATION:Ethics approval was obtained from the Institutional Review Board of Shanghai Children's Medical Center affiliated with Shanghai Jiao Tong University of Medicine. We plan to publish the results of this study in a peer-reviewed journal article.

SUBMITTER: Xu J

PROVIDER: S-EPMC5724237 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Paediatric asthma control under a community management model in China: a protocol for a prospective multicentre cohort study.

Xu Juan J Yin Yong Y Zhang Hao H Zhong Wen Wei WW Zhang Lei L Zhang Jing J Yuan Shu Hua SH Zhang Fen F Zhao Li Xia LX

BMJ open 20170804 8

<h4>Introduction</h4>Childhood asthma is globally one of the most common respiratory disorders and accounts for more school absences and more hospitalizations than any other chronic illness. The worldwide economic burden of this disease exceeds those of HIV/AIDS and tuberculosis combined. Proper intervention and effective management is of paramount importance for the control and prognosis of paediatric asthma. Unfortunately, the rate of uncontrolled and partially controlled paediatric asthma in ...[more]

PMID: 28780547

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Project description:INTRODUCTION:Acute chest pain represents a major healthcare burden in emergency departments (ED) throughout the world. Among these patients, rapidly determining whether an acute coronary syndrome (ACS) is evolving remains difficult. In China, there are limited data correlating the baseline characteristics, evaluation and management of ED patients with acute chest pain and ACS-related symptoms with clinical outcomes. Nor has there been an evaluation of outcomes at different levels of hospitals. The Evaluation and Management of Patients with Acute ChesT pain in China (EMPACT) study will address this evidence gap through a regional representative prospective registry. METHODS AND ANALYSIS:Twenty-two public hospitals with ED in Shandong province have been selected based on a stratified random sampling approach. A total of 10?000 patients with acute chest pain or suspected ACS presenting to the ED will be consecutively enrolled from January 2016 to September 2017. Episodes of care will be evaluated for key performance measures such as the time to first ECG, receipt of troponin testing, receipt of reperfusion therapy for ST segment elevation ACS and provision of angiography for troponin-positive patients. All patients will be assessed for the composite endpoint of adjudicated major adverse cardiac events in 30 days after presentation, including death from all causes, non-fatal myocardial infarction, urgent revascularisation, stroke, cardiac arrest and cardiogenic shock. The secondary outcomes include revisit to ED and rehospitalisation within 30 days. ETHICS AND DISSEMINATION:Ethics approval was obtained at all participating centres. The registry is the first attempt to comprehensively evaluate the current emergency care of acute chest pain from a regional representative sample in China. Findings will allow new opportunities to facilitate the clinical quality improvements and ultimately reduce the mortality in patients with acute chest pain and suspected ACS. TRIAL REGISTRATION NUMBER:NCT02536677; Pre-results.

Project description:INTRODUCTION:The treatment decision and long-term outcomes of previously untreated cerebral cavernous malformation (U-CCM) are still controversial. Therefore, we are conducting a nationwide multicentre prospective registry study in China to determine the natural history and effect of surgical treatment on long-term outcomes in Chinese people with U-CCM. METHODS AND ANALYSIS:This study was started on 1 January 2018 and is currently ongoing. It is a cohort follow-up study across a 5-year period. Patients will be followed up for at least 3 years after inception. Patients with U-CCM will be enrolled from 24 Grade III, level A hospitals distributed all over China. The cohort size is estimated to be 1200 patients. Patients are registered in surgically treated group and conservatively treated group. Clinical characteristics, radiology information and laboratory data are prospectively collected using an electronic case report form through an electronic data capture system. The primary outcome of this study is poor clinical outcome at the last follow-up (modified Rankin Scale score >2 lasting at least 1 year). The secondary outcome includes symptomatic haemorrhage, drug refractory epilepsy, focal neurological deficits, morbidity and all-cause mortality during follow-up. Univariate and multivariate regression analysis will be performed to determine the risk factors for poor outcomes in all patients, and to estimate the effect of surgery. Life tables, Kaplan-Meier estimates, log-rank test and proportional hazards Cox regression will be used to analyse the follow-up data of conservatively treated patients to determine the natural history of U-CCM. Initial presentation and location of U-CCM are prespecified subgroup factors. ETHICS AND DISSEMINATION:The study protocol and informed consent form have been reviewed and approved by the Research Ethical Committee of First Affiliated Hospital of Fujian Medical University (FAHFMU-2018-003).Written informed consent will be obtained from each adult participant or from the guardian of each paediatric participant. The final results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT03467295.

Project description:IntroductionHyperkalaemia (HK) is a potentially life-threatening electrolyte imbalance associated with several adverse clinical outcomes and is common in patients with kidney failure. However, there is no evidence on the occurrence, recurrence and treatment of HK in patients on haemodialysis (HD) in China.Methods and analysisThe HK Prevalence, Recurrence, and Treatment in Haemodialysis Study is a prospective, multicentre, observational, cohort study being conducted across 15-18 sites in China. Approximately 600 patients with end-stage kidney disease on HD are anticipated to be enrolled and will be followed up for 24 weeks. Patients will be in the long interdialytic interval (LIDI) at enrolment and will receive follow-up care every 4 weeks in LIDI for pre-dialysis and post-dialysis (at enrolment only) serum potassium measurements. To obtain pre-dialysis serum potassium levels in the short interdialytic interval (SIDI), a follow-up visit will be performed in the SIDI during the first week. Information on concomitant medications, blood gas analysis and biochemistry measurements will be obtained at enrolment and at each follow-up visit. The primary endpoint will be the proportion of patients experiencing HK (defined as serum potassium level >5.0 mmol/L) at the study enrolment or during the 24-week follow-up. The key secondary endpoint will be the proportion of patients experiencing HK recurrence (defined as any HK event after the first HK event) within 1-6 months (if applicable) during the 24-week follow-up, including enrolment assessment.Ethics and disseminationThis study has been approved by Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee (2020-040). Other participating subcentres must also obtain ethics committee approval prior to the start of the study. The Good Clinical Practice regulations shall be strictly followed during the test implementation. Amendments to the protocol will be reviewed by the ethics committees. Written informed consent will be obtained from all participants before collection of any patient data and patient information. The findings of this study will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberClinicalTrials.gov Registry (NCT04799067).

Project description:INTRODUCTION:Hospitalised patients with nasogastric/nasoenteric tube (NGT/NET) are at constant risk of incidents; therefore, healthcare professionals need to routinely monitor risks and adopt strategies for patient safety and quality of care. AIM:This study aimed to evaluate the NGT/NET-related incidents in hospitalised patients and associated factors. METHODS:This is a multicentre study, with a prospective cohort design. Data will be collected at the general medical ward of seven Brazilian hospitals in the north, northeast, southeast and south. The sample will consist of 391 patients that require an NGT/NET during hospitalisation. Three different methods will be used to identify the incidents: (1) healthcare professionals and patients/caregivers will be required to report any NGT/NET-related incidents; (2) researchers will visit the wards to get information about the incidents with healthcare professionals and patients/caregivers; (3) the researchers will review the medical records looking for information on the occurrence of any NGT/NET-related incidents. Demographic, clinical and therapeutic details will be obtained from the medical records and will be registered in an electronic data collection tool developed for the purposes of this study. The complexity of patients will be assessed by the Patient Classification System, and the severity of comorbid diseases will be assessed through the Charlson Comorbidity Index. IMPLICATION FOR PRACTICE:The results may encourage the use of evidence effectively to influence the scientific foundation for clinical practice and the development of evidence-based policies that will prevent, manage and eliminate complications caused by NGT/NET-related incidents, and improve the quality and safety of care provided to hospitalised patients. ETHICS AND DISSEMINATION:The study has been approved by the Research Ethics Committee. Detailed information about the study can be provided by the principal investigator. The findings will be reported through academic journals, seminar and conference presentations, social media, print media, the internet and community/stakeholder engagement activities.

Project description:IntroductionCrohn's disease and ulcerative colitis are common chronic idiopathic inflammatory bowel diseases (IBD), which cause considerable morbidity. Although the precise mechanisms of disease remain unclear, evidence implicates a strong multidirectional interplay between diet, environmental factors, genetic determinants/immune perturbations and the gut microbiota. IBD can be brought into remission using a number of medications, which act by suppressing the immune response. However, none of the available medications address any of the underlying potential mechanisms. As we understand more about how the microbiota drives inflammation, much interest has focused on identifying microbial signals/triggers in the search for effective therapeutic targets. We describe the establishment of the Australian IBD Microbiota (AIM) Study, Australia's first longitudinal IBD bioresource, which will identify and correlate longitudinal microbial and metagenomics signals to disease activity as evaluated by validated clinical instruments, patient-reported surveys, as well as biomarkers. The AIM Study will also gather extensive demographic, clinical, lifestyle and dietary data known to influence microbial composition in order to generate a more complete understanding of the interplay between patients with IBD and their microbiota.MethodsThe AIM Study is an Australian multicentre longitudinal prospective cohort study, which will enrol 1000 participants; 500 patients with IBD and 500 healthy controls over a 5-year period. Assessment occurs at 3 monthly intervals over a 24-month period. At each assessment oral and faecal samples are self-collected along with patient-reported outcome measures, with clinical data also collected at baseline, 12 and 24 months. Intestinal tissue will be sampled whenever a colonoscopy is performed. Dietary intake, general health and psychological state will be assessed using validated self-report questionnaires. Samples will undergo metagenomic, transcriptomic, proteomic, metabolomic and culturomic analyses. Omics data will be integrated with clinical data to identify predictive biomarkers of response to therapy, disease behaviour and environmental factors in patients with IBD.Ethics and disseminationEthical approval for this study has been obtained from the South Eastern Sydney Local Health District Research Ethics Committee (HREC 2019/ETH11443). Findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals.Trial registration numberACTRN12619000911190.

Project description:IntroductionAdverse events (AEs), defined as unintended patient harm related to healthcare provided rather than an underlying medical condition, represent a significant threat to patient safety and public health. The emergency department (ED) is a high-risk patient safety setting for many reasons including presentation 'outside of regular hours', high patient volumes, and a chaotic work environment. Children have also been identified as particularly vulnerable to AEs. Despite the identification of the ED as a high-risk setting and the vulnerability of the paediatric population, little research has been conducted regarding paediatric patient safety in the ED. The study objective is to generate an estimate of the risk and type of AEs, as well as their preventability and severity, for children seen in Canadian paediatric EDs.Methods and analysisThis multicentre, prospective cohort study will enrol patients under 18 years of age from nine paediatric EDs across Canada. A stratified cluster random sampling scheme will be used to ensure patients recruited are representative of the overall ED population. A rigorous, standardised two-stage process will be used for AE identification. The primary outcome will be the proportion of children with AEs associated with ED care in the 3 weeks following the ED visit. Secondary outcomes will include the proportion of children with preventable AEs and the types and severity of AEs. We will aim to recruit 5632 patients over 1 year and this will allow us to detect a proportion of patients with an AE of 5% (to within an absolute margin of error of 0.6%).Ethics and disseminationEthics approval has been obtained from participating sites. Results will be disseminated through presentations, peer review publications, linkages with emergency research network and a webinars for key knowledge user groups.Trial registration numberThis study is registered at Clinicaltrials.gov (NCT02162147; https://clinicaltrials.gov/ct2/show/NCT02162147).

Project description:IntroductionClinical recommendations for childhood asthma are often based on data extrapolated from studies conducted in adults, despite significant differences in mechanisms and response to treatments. The Paediatric Asthma in Real Life (PeARL) Think Tank aspires to develop recommendations based on the best available evidence from studies in children. An overview of systematic reviews (SRs) on paediatric asthma maintenance management and an SR of treatments for acute asthma attacks in children, requiring an emergency presentation with/without hospital admission will be conducted.Methods and analysisStandard methodology recommended by Cochrane will be followed. Maintenance pharmacotherapy of childhood asthma will be evaluated in an overview of SRs published after 2005 and including clinical trials or real-life studies. For evaluating pharmacotherapy of acute asthma attacks leading to an emergency presentation with/without hospital admission, we opted to conduct de novo synthesis in the absence of adequate up-to-date published SRs. For the SR of acute asthma pharmacotherapy, we will consider eligible SRs, clinical trials or real-life studies without time restrictions. Our evidence updates will be based on broad searches of Pubmed/Medline and the Cochrane Library. We will use A MeaSurement Tool to Assess systematic Reviews, V.2, Cochrane risk of bias 2 and REal Life EVidence AssessmeNt Tool to evaluate the methodological quality of SRs, controlled clinical trials and real-life studies, respectively.Next, we will further assess interventions for acute severe asthma attacks with positive clinical results in meta-analyses. We will include both controlled clinical trials and observational studies and will assess their quality using the previously mentioned tools. We will employ random effect models for conducting meta-analyses, and Grading of Recommendations Assessment, Development and Evaluation methodology to assess certainty in the body of evidence.Ethics and disseminationEthics approval is not required for SRs. Our findings will be published in peer reviewed journals and will inform clinical recommendations being developed by the PeARL Think Tank.Prospero registration numbersCRD42020132990, CRD42020171624.

Dataset Information

Paediatric asthma control under a community management model in China: a protocol for a prospective multicentre cohort study.

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Paediatric asthma control under a community management model in China: a protocol for a prospective multicentre cohort study.

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