The ageing population in Europe is experiencing a significant rise in urinary incontinence (UI), which affects millions and incurs substantial healthcare costs. While conservative treatment (eg, behavioural strategies, pelvic floor exercises) can help manage UI, there is a need for evidence-based eHealth solutions to improve adherence and treatment outcomes. The KOKU Bladder project aims to co-create, develop and test an eHealth intervention to improve bladder health (BH) and UI in adults aged 50 and over.
Phase 1 will consist of the co-creation and technological development of the eHealth solution. First, a rapid review will be undertaken to identify eHealth solutions (ie, technologies and websites), including behaviour change techniques (BCTs) and elements of gamification for self-management of BH and UI in adults aged 50 and over. Also, a consultation with eight experts on BH/UI and/or BCTs will be conducted to explore recommendations for the new eHealth solution. The PROSECO framework will facilitate an assessment of the co-creation process. Phase 1 will additionally include the conduction of at least six focus groups, to be held in Kaunas (Lithuania), Catalonia (Spain) and Manchester (UK) to co-create the contents of the digital solution. Each focus group will include 10–12 community-dwelling adults aged 50+, with different physical conditions and continence status, as well as health professionals and other stakeholders. The information collected will be analysed thematically. First, we will hold three focus groups, one in each country, to find out the opinion of the participants. Once the focus groups are finished and the first version of the technological solution is created, participants will test it and provide feedback in three additional focus groups. Participants’ opinions will be taken into account to make modifications to the solution and co-create the final version. Gamification methods and the Honeycomb model for user experience will be followed in order to achieve a technological solution that is adequate for its target population.
Phase 2 will consist of a multicentre pilot study with a mixed method (quantitative and qualitative) approach to assess the feasibility and acceptability of the newly developed technological solution. At least 120 participants (40 per country) will be recruited and randomised into two groups: intervention (KOKU Bladder) and control (indirect health education). The primary outcome will be the severity of UI, according to the International Consultation on Incontinence Questionnaire-UI short form. Secondary outcomes will include quality of life (EuroQol 5-Dimension, 5-Level), life-impact related to UI (Incontinence Impact Questionnaire-7), lower urinary tract symptoms (Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-10 (LURN SI-10)), International Consultation Questionnaire on Incontinence Bowel Score, Patient Global Impression of Improvement; levels of physical activity and sedentary behaviour (accelerometer), as well as satisfaction with treatment (Client Satisfaction Questionnaire (CSQ-8)). The latter, together with recruitment, adherence, retention, attrition and data loss, will be used for measuring intervention feasibility and acceptability. Statistical and clinical significance, as well as effect size, will be calculated.
The project is approved by the Research Ethics Committee of IRIS-CC approved the project on 9 January 2025 (code 24/095), the Research Ethics Committee of Hospital Universitari Arnau de Vilanova of Lleida on 27 January 2025 (CEIC-3201), the Commission on Research Ethics of Lithuania on 3 March 2025 (SMTEK-31) and the Research Ethics Committee 3 of the University of Manchester on 13 August 2025 (2025-23619-43258). Participation and withdrawal will be voluntary. Informed consent will be obtained from candidates willing to join the project. Study results will be disseminated via publication of scientific articles, presentations at professional workshops, webinars and congresses, as well as through social media and lay summaries for participants and the general public.
CRD42024597624.
To determine whether postponing daily medical rounds to provide additional preparation time for residents reduces round duration and alters time allocation during rounds, with the hypothesis that increased preparation leads to more efficient rounds without reducing patient contact.
Time and motion study with a before-and-after comparison.
Internal medicine division of Lausanne University Hospital, a Swiss tertiary teaching hospital.
75 residents; 60% women; mean age of 29.6 years and 3.0 years of training.
In 2017, the daily work schedule was reorganised by postponing rounds from 09:00 to 10:00 and moving educational sessions to the afternoon, thereby freeing 90 min to prepare patient cases before rounds.
The primary outcome was the duration of rounds and the proportion thereof spent with patients, using computer systems or in discussion with colleagues. Secondary outcomes included the detailed distribution of resident activities during the officially scheduled round period, particularly time dedicated to supervision, teaching and administrative tasks.
Round duration decreased from 142 min per shift (95% CI 128 to 156) in 2015 to 112 min (95% CI 101 to 124) in 2018 (p=0.001). The proportion of round time spent directly with patients remained stable at 47%. Computer use during rounds decreased from 43% to 32% (p
Postponing rounds to allow more preparation time was associated with shorter, possibly more efficient rounds, reduced computer use in patient presence and increased supervision and teaching.
ISRCTN69703381,
A synthesis and appraisal of the recommendations for biomarkers in practice guidelines concerning sepsis is required to consolidate evidence-based practice. We generated an evidence gap map (EGM) on the use of biomarkers for managing adults with sepsis.
Scoping review.
MEDLINE, Guidelines International Network, Pan American Health Organization, Trip Database and UpToDate were searched from 2016 to March 2025.
Guidance documents (GD) that searched at least one literature source and provided clinical recommendations for the use of biomarkers for the management (diagnosis and prognosis, including treatment response) of adults with sepsis.
Two reviewers independently applied the eligibility criteria and extracted data. We used the AGREE-II (Appraisal of Guidelines for Research and Evaluation) tool to assess the GD quality. GDs that scored ≥50% on the AGREE-II 'Rigour of development' domain were considered robust. We also applied the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system to evaluate if the recommendations were strong or conditional.
We found 10 GDs, with only half (4/8) having a robust methodology. There were 31 recommendations concerning biomarkers. Among these, 24 (77.4%) recommendations were about single biomarkers, with lactate (23; 74.2%) and procalcitonin (8; 25.8%) most frequently recommended. Biomarker testing focused on prognosis in 28 (90.3%) recommendations. Overall, 16 (51.6%) recommendations were graded strong and 13 (42.0%) were conditional, which we displayed in an EGM.
The methodology of GDs concerning adult sepsis was poor. Our review calls for more prudent use of biomarkers in specific prognostic scenarios and in combination with standard clinical assessments. Enhancing the methodological quality of future GDs is essential to generate more valid and robust recommendations for optimising patient care.
Intensive care units (ICUs) manage patients with or likely to have one or more life-threatening acute organ failures that might require the use of invasive supportive therapies. The use of physical restraint is frequent, with rates up to 50%, and usually initiated to maintain patient safety especially if the patient is agitated. Physical restraints have been associated with delirium, post-traumatic stress disorder and physical injuries while restricting patients’ individual freedom. Moreover, the incidence of invasive therapeutic devices’ self-removal by patients might not be decreased by physical restraint use. No recommendation is available concerning ICU patients and physical restraint management, despite being a daily practice. The main objective is to evaluate whether a strategy aimed at decreasing physical restraint use in ICU patients with that of a strategy based on routine and subjective caregivers’ decision is safe and efficient.
ARBORea is a multicentre randomised, stepped-wedge trial testing an innovative, dedicated web-based, multiprofessionally developed, experts validated, nursing management strategy in comparison with standard care. The primary outcome is physical restraint use rate (effectiveness) measured at least every 8 hours and incidents’ rate (tolerance) defined as the rate of incidents attributable to non-compliance, corresponding to the deterioration or self-removal of critical devices, a fall or self-aggressive or heteroaggressive behaviours. Planned enrolment is 4000 ICU adult participants at 20 French academic and non-academic centres. Safety and long-term outcomes will be evaluated.
Trial results will be reported according to the Consolidated Standards of Reporting Trials 2010 guidelines. Findings will be published in peer-reviewed journals and presented at local, national and international meetings and conferences to publicise and explain the research to clinicians, commissioners and service users. The trial is funded by the French Ministry of Health and has been approved by the French local ethics committee (Comité de Protection des Personnes Sud-Ouest et Outre-Mer 2, Toulouse, France with registration number: 2020-A02904-35).
(ClinicalTrials.gov) NCT04957238 on 12 July 2021 before first inclusion in study.