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To explore the long-term communicative experiences of tracheostomised ICU survivors 12 months after discharge; to identify facilitators and barriers to communication with caregivers, family members, and healthcare professionals; to describe coping and communicative adaptation strategies; and to assess perceived quality of life and self-esteem.
This is a qualitative-dominant mixed methods study based on a multicentre Italian sample.
Twenty-three adult patients from several Italian hospitals were interviewed using a semi-structured guide 12 months after discharge. Qualitative data were analysed using reflexive thematic analysis. Quantitative data were collected through the EQ-5D-5L, EQ-VAS, and Visual Analogue Self-Esteem Scale (VASES), and analysed using descriptive statistics to explore patterns of QoL and self-esteem.
Four major themes emerged: (1) A body that speaks no more, reflecting the initial experience of voicelessness and emotional isolation; (2) Finding new ways to be heard, describing adaptive communicative strategies and the supportive role of family; (3) When the voice returns, so does life, highlighting the transformative meaning of regaining one's voice; and (4) Living differently, capturing long-term psychological and social adjustments. Quantitative data confirmed reduced self-esteem and QoL (mean EQ-5D index = 0.61; EQ-VAS = 58.4; VASES = 54.2). Integrated findings revealed that communication impairment remained a determinant of reduced well-being 1 year after discharge.
This is the first Italian study to investigate in depth the communicative trajectories of tracheostomised ICU survivors. Findings highlight the crucial role of voice recovery in emotional adjustment and quality of life, supporting the need for structured, multidisciplinary post-ICU follow-up focused on communication and psychosocial rehabilitation.
These findings support health professionals in developing individualised post-ICU interventions to restore communication, improve QoL, and enhance social reintegration.
COREQ checklist was followed.
No patient or public contribution.
Diagnostic stewardship is an emerging concept, so far primarily associated with microbiology, specifically antibiotic stewardship. However, its core idea, ensuring ‘the right test at the right time for the right patient’, holds relevance across all areas of clinical medicine. By optimising the diagnostic process, diagnostic stewardship aims to enhance clinical decision-making and promote more effective, efficient and patient-centred care. Key objectives are the reduction of diagnostic errors, namely overdiagnosis, underdiagnosis and misdiagnosis, as well as optimal resource management. The aim of our review was to establish whether and how diagnostic stewardship has been implemented outside the area of antibiotic stewardship.
This scoping review will be conducted in accordance with the Joanna Briggs Institute (JBI) guidelines and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews (PRISMA-ScR) checklist. Medline, Embase, Web of Science, Scopus, Google Scholar and Proquest Thesis and Dissertation will be searched using a search strategy based on the population, concept, context (PCC) framework, adding an outcome variable. Studies will be screened by two independent reviewers and reported using the PRISMA flowchart. Included will be studies starting from 2015, which will describe stewardship interventions in different diagnostic modalities. Excluded will be results regarding antimicrobial stewardship. No language restriction will be applied. Information on the definition and application of the concept of diagnostic stewardship, as well as general study characteristics, will be extracted using a previously developed and piloted data extraction form. Extracted data will be analysed and reported using narrative and descriptive analysis.
Ethics approval is not required for this scoping review. Dissemination activities include peer-reviewed journal publication and conference presentations.
This study aims to determine the medico-social factors that predicted workers’ low work ability (LWA) leading to long-term absenteeism and permanent medical unfitness for work.
This was a cross-sectional analysis based on a cohort of workers followed up by an occupational health service in the south of France.
Employees visited by the service completed the Work Ability Index (WAI), a self-administered questionnaire. A score of 26 points or more defines high work ability while a score of 25 points or less defines LWA (scoring from 6 to 50 points). Occupational and medico-social data were obtained from computerised medical records. Logistic regression models were applied.
Of the 2104 WAIs completed the baseline questionnaire, the factors most associated with LWA were mental disorders (OR: 3.46), adaptation of the workstation (OR: 2.88) and long/iterative stoppages (OR: 2.87). Blue collar (OR: 2.50), white collar (OR: 2.34), permanent contracts (OR: 1.79), disability (OR: 2.63), recognition as a disabled worker (OR: 2.37), musculoskeletal disorders of the neck (OR: 2.52) and back (OR: 1.69) also appear to be associated with a risk of LWA.
White-collar and blue collar workers affected by mental disorders and musculoskeletal disorders of the neck and back appear to be significantly associated with a risk of LWA. To adjust LWA preventive measures, future studies are needed to discuss further these risk factors.
To adapt an instrument to measure patient safety culture, as rated by home care workers, and examine its psychometric properties.
A multicentre cross-sectional psychometric study.
We adapted the Nursing Home Survey SOPS to measure safety culture in home care. The questionnaire was translated to French following the Translation, Review, Adjudication, Pretest and Documentation (TRAPD) approach. Experts in home care evaluated the content validity of the adapted and translated instrument. To pre-test the questionnaire, we conducted cognitive interviews. We invited home care workers from two home care agencies in the French-speaking region of Switzerland to participate in the cross-sectional study from November to December 2024. We performed confirmatory factor analysis using the R package ‘lavaan’ and assessed convergent, discriminant and known-groups validity.
Eight experts assessed the content validity of the adapted and translated instrument. Responses from 672 home care workers were analysed. Except for compliance with procedures, all dimensions showed acceptable or good internal consistency. Regarding construct validity, first-order and second-order level confirmatory factor analysis showed acceptable model fit. Safety culture correlated with overall patient safety rating and psychosocial safety climate. Regarding known-groups validity, participants who do not work directly with clients most of the time, and those willing to recommend the organisation rated the safety culture higher.
The psychometric evaluation indicated that the adapted instrument can be used as a valid and targeted tool to assess patient safety climate/culture in Swiss French-speaking home care agencies.
The existence of an adapted and validated instrument for use in home care enables managers to monitor safety culture and develop interventions to improve it and consequently ensure patient safety.
To the best of our knowledge, there was no instrument specifically targeting the measurement of patient safety culture in the home care setting. The adapted instrument for home care showed to be a valid tool to provide information about safety culture in this setting. The availability of an instrument to measure safety culture in the home care setting can promote its monitoring, raise awareness of safety culture among staff, help managers prioritise key aspects for culture change, and thus improve patient safety. A wider adoption of the same instrument could also facilitate comparative analyses.
We used the COSMIN guidelines for the psychometric evaluation of the instrument and the STROBE reporting guidelines for the cross-sectional study.
This study did not include patient or public involvement in its design, conduct or reporting.
To assess the feasibility and preliminary effectiveness of ‘Partners for Patient Safety’ (P4PS) programme for strengthening competencies and patient engagement at the organisational level.
Prospective study with three measurement points (baseline, interim and follow-up) and an explanatory sequential mixed methods approach for formative and process evaluation.
Oncology-focused patient and family advisory councils (PFACs) integrated into healthcare organisations and networks in five German federal states.
Initially, 36 stakeholders of six PFACs were recruited. At follow-up, 27 participated in all intervention modules and completed all surveys. From those, 14 participated in follow-up interviews.
The P4PS programme consists of two sequentially implemented modules: (1) an e-learning module and (2) a 4-hour on-site workshop. The programme focuses on the following topics: patient safety (PS), communication strategies and PFAC engagement in respective care organisations.
Primary outcome measures were feasibility domains, assessed via standardised (acceptability, appropriateness, feasibility) and self-developed measures (relevance, acceptability and social validity, complexity and practicability, demand and implementation, and adaptability). Secondary outcome measure was preliminary effectiveness, measured via changes in self-assessed competencies in PS, communication and engagement.
Feasibility ratings were high across standardised and self-developed measures (median range: 4–5 of 5). Qualitative data showed P4PS programme’s practical relevance, need for organisational support and its adaptability across PFAC contexts. Effectiveness analyses showed significant improvements in PS competencies (adjusted pV) and selected domains of PFAC engagement (adjusted pd=–0.77 to –1.37). Participants expressed strong expectations for future improvements in competencies regarding PS, communication and PFAC engagement.
This P4PS programme showed high feasibility and effectiveness, it increased key competencies, clarified roles and promoted active PFAC engagement in PS. Future work needs to address organisational support and sustainable implementation with application to context as well as long-term evaluation across different care settings.
DRKS00034733; German Clinical Trials Register.
There is an absence of real-world evidence, especially from low- and middle-income countries (LMICs), on the implementation successes and challenges of COVID-19 Test and Treat (T&T) programmes. In 2022, nirmatrelvir/ritonavir was provided as standard of care for mild to moderate COVID-19 treatment in eight LMICs (Ghana, Kenya, Laos, Malawi, Nigeria, Rwanda, Uganda and Zambia). This manuscript describes a research protocol to study novel drug introduction during the COVID-19 health emergency, with implications and learnings for future pandemic preparedness. The goal of the study is to provide simultaneous programme learnings and improvements with programme rollout, to fill a gap in real-world implementation data on T&T programmes of oral antiviral treatment for COVID-19 and inform programme implementation and scale-up in other LMICs.
This multiple methods implementation research study is divided into three components to address key operational research objectives: (1) programme learnings, monitoring and evaluation; (2) patient-level programme impact; and (3) key stakeholder perspectives. Data collection will occur for a minimum of 6 months in each country up to the end of grant. Quantitative data will be analysed using descriptive statistics for each country and then aggregated across the programme countries. Stakeholder perspectives will be examined using the Consolidated Framework for Implementation Research implementation science framework and semistructured interviews.
This study was approved by the Duke University Institutional Review Board (Pro00111388). The study was also approved by the local institutional review boards in each country participating in individual-level data collection (objectives 2 and 3): Ghana, Malawi, Rwanda, Nigeria and Zambia. The study’s findings will be published in peer-reviewed journals and disseminated through dialogue events, national and international conferences and through social media.
Histopathological evaluation of prostate biopsies using the Gleason scoring system is critical for prostate cancer diagnosis and treatment selection. However, grading variability among pathologists can lead to inconsistent assessments, risking inappropriate treatment. Similar challenges complicate the assessment of other prognostic features like cribriform cancer morphology and perineural invasion. Many pathology departments are also facing an increasingly unsustainable workload due to rising prostate cancer incidence and a decreasing pathologist workforce coinciding with increasing requirements for more complex assessments and reporting. Digital pathology and artificial intelligence (AI) algorithms for analysing whole slide images show promise in improving the accuracy and efficiency of histopathological assessments. Studies have demonstrated AI’s capability to diagnose and grade prostate cancer comparably to expert pathologists. However, external validations on diverse data sets have been limited and often show reduced performance. Historically, there have been no well-established guidelines for AI study designs and validation methods. Diagnostic assessments of AI systems often lack preregistered protocols and rigorous external cohort sampling, essential for reliable evidence of their safety and accuracy.
This study protocol covers the retrospective validation of an AI system for prostate biopsy assessment. The primary objective of the study is to develop a high-performing and robust AI model for diagnosis and Gleason scoring of prostate cancer in core needle biopsies, and at scale evaluate whether it can generalise to fully external data from independent patients, pathology laboratories and digitalisation platforms. The secondary objectives cover AI performance in estimating cancer extent and detecting cribriform prostate cancer and perineural invasion. This protocol outlines the steps for data collection, predefined partitioning of data cohorts for AI model training and validation, model development and predetermined statistical analyses, ensuring systematic development and comprehensive validation of the system. The protocol adheres to Transparent Reporting of a multivariable prediction model of Individual Prognosis Or Diagnosis+AI (TRIPOD+AI), Protocol Items for External Cohort Evaluation of a Deep Learning System in Cancer Diagnostics (PIECES), Checklist for AI in Medical Imaging (CLAIM) and other relevant best practices.
Data collection and usage were approved by the respective ethical review boards of each participating clinical laboratory, and centralised anonymised data handling was approved by the Swedish Ethical Review Authority. The study will be conducted in agreement with the Helsinki Declaration. The findings will be disseminated in peer-reviewed publications (open access).
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