Multicentre double-blind randomised controlled trial of systematic corticosteroid therapy in patients with acute exacerbations of chronic obstructive pulmonary disease admitted to hospital with higher eosinophil levels: the ECHO protocol.

INTRODUCTION: Corticosteroid is one of the most commonly used medications in patients with acute exacerbations of chronic obstructive pulmonary disease (AECOPD). The increasing understanding of these side-effects of systematic corticosteroids and their better response to treatment among patients with COPD with higher blood eosinophil counts has led to an interest in a more targeted approach to systematic corticosteroid treatment. However, there is a lack of evidence from high-quality randomised controlled trial (RCT) studies about whether initial systematic corticosteroids should be given to patients with AECOPD with elevated eosinophilia. The aim of the present research was to test this hypothesis. METHODS AND ANALYSIS: This is a multicentre, double-blind, superiority RCT in the respiratory departments of 12 general hospitals in China. It is anticipated that 456 patients with AECOPD with a blood eosinophil count >2% or >300 cells/µL at admission will be recruited. Eligible patients will be randomised (1:1) to the intervention group receiving 40 mg oral prednisone daily or identical-appearing placebo (control group) for five consecutive days. Follow-up visits are performed during hospitalisation, followed by clinic interviews on days 30, 60 and 90 after discharge. The primary outcome is treatment failure rates comprising requiring or receiving invasive or non-invasive mechanical ventilation, requiring or transferring to intensive care unit during the index hospitalisation, length of index hospitalisation longer than 14 days, death during the index hospitalisation or within 30 days after discharge and readmission with acute exacerbations of COPD within 30 days after discharge. The results of this trial will provide insight into the value of using blood eosinophil counts as a biomarker of eosinophilic exacerbation and initiating systematic corticosteroid treatment for patients with AECOPD with higher eosinophil levels. ETHICS AND DISSEMINATION: This study was approved by Beijing Chaoyang Hospital Institutional Review Board (approval number: 2020-KE-544) and the main results and secondary results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05059873.

Researching the hard-to-reach: a scoping review protocol of digital health research in hidden, marginal and excluded populations.

INTRODUCTION: There is a significant growth in the use of digital technology and methods in health-related research, further driven by the COVID-19 pandemic. This has offered a potential to apply digital health research in hidden, marginalised and excluded populations who are traditionally not easily reached due to economic, societal and legal barriers. To better inform future digital health studies of these vulnerable populations, we proposed a scoping review to comprehensively map published evidence and guidelines on the applications and challenges of digital health research methods to hard-to-reach communities. METHODS AND ANALYSIS: This review will follow the Arksey and O' Malley methodological framework for scoping reviews. The framework for the review will employ updated methods developed by the Joanna Briggs Institute including the Preferred Reporting Items for Systematic reviews and Meta-Analysis Scoping Review checklist. PubMed, the Cochrane Library, PsycINFO, Google Scholar and Greenfile are the identified databases for peer-reviewed quantitative and qualitative studies in-scope of the review. Grey literature focused on guidance and best practice in digital health research, and hard-to-reach populations will also be searched following published protocols. The review will focus on literature published between 1 February 2012 and 1 February 2022. Two reviewers are engaged in the review. After screening the title and abstract to determine the eligibility of each article, a thorough full-text review of eligible articles will be conducted using a data extraction framework. Key extracted information will be mapped in tabular and visualised summaries to categorise the breadth of literature and identify key digital methods, including their limitations and potential, for use in hard-to-reach populations. ETHICS AND DISSEMINATION: This scoping review does not require ethical approval. The results of the scoping review will consist of peer-reviewed publications, presentations and knowledge mobilisation activities including a lay summary posted via social media channels and production of a policy brief.