Digitalisation in healthcare has resulted in fragmented solutions and limited interoperability. The Fast Healthcare Interoperability Resources (FHIR) standard is increasingly adopted to enable standardised data exchange, yet its complexity creates usability challenges for clinicians and developers. To address these challenges, this study evaluates the usability of an enhanced FHIR Questionnaire Resource Editor designed to improve workflow efficiency, accessibility and user satisfaction in creating and managing healthcare questionnaires.

This mixed-methods usability evaluation will recruit 10 healthcare professionals and/or informatics experts via convenience sampling. The study will consist of four general phases: (1) an initial session to familiarise users with the tool; (2) a task analysis phase supported by eye-tracking to identify strengths and weaknesses; (3) retrospective think-aloud interviews to explore strategies used during tasks and (4) completion of a validated usability questionnaire, such as the System Usability Scale, to quantify user satisfaction. We will analyse quantitative data using descriptive and inferential statistics. Qualitative feedback will be examined through thematic analysis and affinity mapping. The primary outcome is to assess the editor’s usability and accessibility and to identify areas for improvement.

This study protocol has been reviewed and approved by the Ethics Committee of the Medical Faculty at the University of Würzburg (ethikkommission@uni-wuerzburg.de) under approval number (24/24-sc). All participants will provide informed consent. Results will be disseminated through peer-reviewed journals, conferences and open-access platforms to inform future iterations of FHIR-based tools.

Persistent pain after finishing breast cancer treatment is a common and disabling problem. The current state-of-the-art pain management advocates, in addition to biomedical (non-)pharmacological approaches, a biopsychosocial rehabilitation approach to address persistent pain, combining pain science education with promoting an active lifestyle through self-regulation techniques. We propose testing an innovative eHealth self-management support programme for this purpose in the breast cancer population with persistent pain after finishing cancer treatment. This delivery mode is believed to reduce barriers to pain self-management by providing timely, safe and cost-effective assistance addressing the biopsychosocial needs of patients. Utilising a chatbot format, the eHealth programme delivers pain science education and promotes physical activity (PA), personalised through decision-tree-based algorithms to support pain self-management. The programme aims to empower patients with understanding, coping skills and self-management techniques to reduce pain-related disability and enhance participation in daily life. The primary objective is to determine programme effectiveness compared with (1) usual care (superiority) and (2) a similar face-to-face pain self-management support programme (non-inferiority).

A pragmatic, three-arm randomised controlled trial was started in April 2024 at the University Hospitals of Antwerp and Leuven and primary care settings in Belgium. Participants are breast cancer survivors with persistent pain after finishing cancer treatment. Two hundred seventy participants will be randomised to one of three trial arms: (1) eHealth self-management support programme, (2) usual care or (3) a face-to-face self-management support programme. The ‘eHealth self-management support programme’ begins with a pain science education (PSE) module to initially convey key pain-related concepts and provide personalised pain management tips. Then, the programme progresses to daily activity planning to promote an active lifestyle. Guided by the Health Action Process Approach (HAPA) model, participants set and review daily activity goals and track progress. The eHealth self-management programme uses a chatbot and is accessible on any digital device. The ‘usual care programme’ involves sending the participants a study-specific brochure by postal mail and does not include any formal PSE and/or PA programmes. They may pursue or continue self-initiated care. In Belgium, usual care primarily involves pharmacological treatment, general advice on PA and the provision of informational brochures. The ‘face-to-face self-management support programme’ mirrors the eHealth intervention, combining PSE with PA coaching. It starts with three individual sessions with a trained physical therapist for biopsychosocial assessment and PSE, followed by six sessions on goal setting and active lifestyle coaching. The educational content is delivered both verbally and in written form. The primary outcome will be pain-related disability 6 months after baseline assessment. As a key secondary outcome, the effect on pain beliefs and attitudes will be investigated after the educational part of the eHealth and face-to-face programme (ie, at 6 weeks after baseline). Other secondary outcomes related to other dimensions of pain and physical-, psychosocial- and health-economic outcomes will be assessed at 12 weeks and 6 and 12 months after baseline as well.

The study will be conducted in accordance with the Declaration of Helsinki (2024). The protocol has been approved by the ethical committee of the University Hospitals of Leuven and Antwerp. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses. Ethical Committee of the University Hospitals Leuven and Antwerp: BUN B3002023000132.

ClinicalTrials.gov Identifier: NCT06308029.

Exacerbations of chronic obstructive pulmonary disease (COPD) can lead to reduced lung function and worse clinical outcomes. Previous studies have reported associations between severe exacerbations and increased risk of hospitalisation and/or mortality. This meta-analysis examined the impact of moderate exacerbations on the risk of future exacerbations and all-cause mortality.

This meta-analysis included seven observational studies from the EXACOS (EXAcerbations of COPD and their OutcomeS)/AVOIDEX (Impact of AVOIDing EXacerbations of COPD) programme studies.

This meta-analysis used data from regional claims databases or electronic healthcare records from seven countries.

The individual studies included patients with a diagnosis of COPD and ≥12 months of data availability before (regarded as baseline) and after the index (ie, the date of the first COPD diagnosis), with postindex data considered the follow-up period.

The number of COPD exacerbations experienced during the baseline period (ie, the exposure variable) was used to categorise patients into the following groups: no exacerbations, one moderate exacerbation only or two or more moderate/severe exacerbations. Outcomes assessed included risk of COPD exacerbations and all-cause mortality during follow-up as a function of baseline exacerbations. For meta-analyses, all rate ratios (RRs) were log-transformed, and associations were pooled across studies using random-effects meta-analysis models.

Among 2 733 162 patients with COPD, one moderate exacerbation was significantly associated with a twofold increased risk of future exacerbations compared with having no exacerbations during baseline, with pooled RRs (95% CIs) of 2.47 (1.47 to 4.14) at 1 year, 2.49 (1.38 to 4.49) at 2 years and 2.38 (1.30 to 4.34) at 3 years postindex. The pooled RR (95% CI) for all-cause mortality was 1.30 (1.05 to 1.62), indicating a 30% increase in risk following one moderate exacerbation versus no exacerbations.

Preventing moderate exacerbations in patients with COPD should be a priority that may improve patient trajectories and outcomes.

For every 100 women having a vaginal birth, approximately four will experience a severe (third-degree or fourth-degree) perineal tear. Severe perineal tears are associated with significant short-term and long-term consequences if not recognised and repaired. There are global efforts to reduce incidence of severe perineal tears including initiatives to strengthen education and training of clinicians in perineal anatomy and perineal tear assessment and classification. This systematic review aimed to describe and evaluate the effectiveness of these initiatives.

Systematic review, reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

Medline (Ovid), CINAHL Complete (EBSCO), MIDIRS and EMBASE (Ovid) were searched through 15 February 2024.

Studies reporting simple or complex interventions aimed at improving the skills and knowledge of clinicians in perineal anatomy and/or the clinical assessment and classification of perineal tears were eligible.

Two reviewers independently screened studies for eligibility and appraised the quality of individual studies using the Cochrane Risk of Bias (RoB) 2.0 tool or Risk of Bias in Non-Randomised Studies of Interventions (ROBINS-I) tool.

In total, 7645 citations were screened and 39 studies included. We identified nine unique interventions including training programmes, short workshops and senior obstetrician supervision. Many studies were from high-income countries, in primary care settings and at high risk of bias.

Effective education included practical components, such as hands-on skills and training in perineal anatomy, assessment and classification, rather than senior supervision alone. Ongoing review of practice appears to be crucial for maintaining knowledge and skills. Future research should focus on interventions tailored to limited-resource settings, and the optimal length and intensity of training programmes to assess and classify perineal tears.

CRD42020185431.

Breast cancer is the most common form of cancer in women. A considerable number of women with breast cancer who have been treated with chemotherapy subsequently develop neurological symptoms such as concentration and memory difficulties (also known as ‘chemobrain’). Currently, there are no validated therapeutic approaches available to treat these symptoms. Cognitive training holds the potential to counteract cognitive impairment. Combining cognitive training with concurrent transcranial direct current stimulation (tDCS) could enhance and maintain the effects of this training, potentially providing a new approach to treat post-chemotherapy subjective cognitive impairment (PCSCI). With this study, we aim to investigate the effects of multi-session tDCS over the left dorsolateral prefrontal cortex in combination with cognitive training on cognition and quality of life in women with PCSCI.

The Neuromod-PCSCI trial is a monocentric, randomised, double-blind, placebo-controlled study. Fifty-two women with PCSCI after breast cancer therapy will receive a 3-week tDCS-assisted cognitive training with anodal tDCS over the left dorsolateral prefrontal cortex (target intervention), compared with cognitive training plus sham tDCS (control intervention). Cognitive training will consist of a letter updating task. Primary outcome will be the performance in an untrained task (n-back task) after training. In addition, feasibility, safety and tolerability, as well as quality of life and performance in additional untrained tasks will be investigated. A follow-up visit will be performed 1 month after intervention to assess possible long-term effects. In an exploratory approach, structural and functional MRI will be acquired before the intervention and at post-intervention to identify possible neural predictors for successful intervention.

Ethical approval was granted by the ethics committee of the University Medicine Greifswald (BB236/20). Results will be available through publications in peer-reviewed journals and presentations at national and international conferences.

ClinicalTrials.gov; NCT04817566, registered on 26 March 2021.