Observational studies play a pivotal role in understanding population health trends and informing public health policy. However, many such studies inadequately address dimensions of health inequality, potentially perpetuating existing disparities. There is currently no comprehensive overview of frameworks specifically designed to integrate health-inequality constructs into observational public health research. This protocol outlines the methodology of the scoping review, which aims to identify, describe and critically evaluate existing frameworks that explicitly incorporate health inequalities within observational studies.
We will conduct this scoping review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. Six electronic databases (PubMed, Embase, Scopus, Web of Science, Global Health and CINAHL) and eligible grey literature sources will be searched using a combination of keywords and subject headings related to health inequalities, observational study design and frameworks. Two independent reviewers will perform title/abstract screening and full-text eligibility assessment using Rayyan, while discrepancies will be resolved by consultation with a third reviewer. Findings will be synthesised narratively.
As this study involves analysis of publicly available literature, formal ethical approval is not required. Results will be disseminated through publication in a peer-reviewed journal, presentations at relevant conferences and communication with key stakeholders in public health and equity research. The results will also be shared directly with charities and local organisations which focus on addressing health inequalities. By providing a comprehensive map of existing frameworks, this review will inform researchers on best practices for embedding health-inequality considerations in observational studies and support the development of more equitable research methodologies.
Recurrent pregnancy loss (RPL) is defined as the occurrence of two or more spontaneous pregnancy losses from the time of conception until 24 weeks of gestation. Currently, an underlying cause can be identified in only a minority of the losses. Potentially, an impaired maternal immune response targeting the semiallograft pregnancy may lead to miscarriage. While prior studies have explored the use of immune-suppressing corticosteroids to modulate the maternal immune system and hopefully improve pregnancy outcome, the absence of sufficiently powered randomised controlled trials (RCT) underscores the need for further research. The primary aim of this study is to evaluate if prednisolone administration in early pregnancy (20 mg daily for 6 weeks, then tapering doses for 2 weeks) in women with unexplained RPL leads to a higher live birth rate (LBR) in comparison to placebo. Additionally, the study assesses the tolerability, safety and the cost-effectiveness of this intervention. Finally, we will explore the effect of prednisolone in various subgroups (based on maternal age, number of previous pregnancy losses, presence of specific antibodies and pre-pregnancy endometrial immune cell level).
This ongoing multicentre, double-blind RCT will randomise 490 women with unexplained RPL and pregnancy
This study was submitted under the Clinical Trial Regulation (CTR) in Clinical Trials Information System (CTIS) for assessment by the Central Committee on Research Involving Human Subjects (CCMO) under Clinical Trial number: 2023-503220-76-01. It received full approval on 29/01/2024. Study findings will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results by publishing them on the publicly available website of the study.
This trial is registered in ClinicalTrials.gov (ID NCT05725512) and in CTIS (2023-503220-76-01).
The objective is to explore patients’ perceptions on the management of atrial fibrillation (AF) and associated comorbidities.
A descriptive qualitative study involving in-depth individual interviews, analysed using Braun and Clarke's approach to Reflexive Thematic Analysis.
Cardiology departments in teaching hospitals in five geographically diverse European countries—Belgium, Greece, Poland, Spain and the Netherlands.
30 adults aged 65 years or older, diagnosed with AF, with two or more confirmed comorbidities were interviewed.
The average age was 73 years, 37% were women and the most common comorbidity was hypertension (n=26, 87%), followed by hypercholesterolaemia (n=12, 40%), obesity (n=10, 33%), hypothyroidism (n=9, 30%) and diabetes (n=7, 23%). Three main themes were identified: (1) navigating the diagnosis path and adapting to life with AF, (2) normalising symptoms and treatment burden and (3) striving to build a therapeutic relationship.
Respondents had some knowledge about the relationship between comorbidities and AF but lacked understanding of how these comorbidities related to AF. Participants raised concerns regarding their medications, especially anticoagulants, with a desire to be given more information about them. Participants were motivated to make lifestyle adjustments but reported a lack of education and advice on how to implement and maintain these lifestyle changes. Overall, participants were very satisfied with their cardiology/AF teams, and they emphasised the importance of a person-centred approach. There was a perceived disjointedness to healthcare systems, with some reporting multiple appointments at different locations, leading to participants being frustrated and highlighting the lack of integrated care.
In-depth interviews provided an excellent platform to explore the perceptions and experiences of patients living with AF and associated comorbidities and highlighted the lack of an integrated approach to multimorbid AF management.