Abstract Background Hospital professionals face mental health challenges caused by the high demands of their work. Mindfulness meditation (MM) is a nonpharmacological practice with promising effects in promoting mental health and well-being across various hospital professionals. However, the benefits obtained from its implementation in the context of real work in hospital departments are understudied. Objective The aims of this pilot study are to implement and evaluate, at both the individual and collective levels, the exploratory outcomes of a workplace-based mindfulness intervention developed participatively for hospital teams in a French university hospital. The feasibility of the implementation of the intervention, the influence of the work environment, and the mechanisms through which it produces its effects will also be assessed. Methods For this prospective interventional study, a preliminary co-construction with the stakeholders (a task force with professionals and management) made it possible to develop and adapt the intervention to the needs and capacities of the professionals, using the intervention mapping model for health program planning. Inclusion and an MM information meeting were proposed to 8 hospital departments, which were then randomized into 2 parallel cluster groups (intervention or control group). In the intervention group, an MM test session was proposed before committing to the MM program (10 one-hour sessions) for a maximum of 15 professionals per department. A convergent mixed methods design with concomitant quantitative and qualitative data collection was used, before integration of findings. Quantitative evaluation was based on a comparison of “before-after” measurements, with a comparison between intervention and control groups. The primary exploratory outcome was the evolution of psychological flourishing at work, which was measured using the adapted and validated French-language scale Psychological Flourishing at Work (EEPMT-8), to which the Professional Life Satisfaction Scale (ÉSVP-5) was added, to form a new 13-item Psychological Flourishing at Work Scale (EEPMT-13). Realist evaluation by qualitative methods explored the influence of contexts on the implementation (barrier and facilitators), and the links between context, mechanisms, and effects of MM. The study was approved by the Sud-Est VI ethics committee (Clermont Ferrand, France). Results Funding was obtained in October 2021 and June 2024. This study was conducted from May 2024 to June 2025. As of May 2024, 108 participants were enrolled. Analyses are in progress. Results are expected to be published by the end of 2026. Conclusions Participative approaches are essential for a challenged, tailored implementation of a workplace-based mindfulness intervention in hospital teams. The evaluation of the intervention with mixed methods and the characterization of both individual and organizational levels are aligned with the recommendations to evaluate a complex intervention in a workplace; challenges include the use of an innovative primary endpoint and methodological pluralism to plan for scalability at a subsequent stage.
Peer support interventions in oncology have shown potential benefits for patients, including reduced psychological distress, improved empowerment, and enhanced care experience. However, the integration of Accompanying Patients (APs), trained individuals with personal experience of cancer into clinical teams remains variable, and the mechanisms underlying their impact are not fully understood. In France, although peer support initiatives are emerging, they often lack structure, evaluation, and coordination. Building on the PAROLE-Onco model developed in Quebec, this study aims to adapt, implement, and evaluate a structured peer-support program within the French healthcare system. This study will use a mixed-methods, multiple-case design across ten oncology units with four organizational contexts. Quantitative data will be collected through validated questionnaires administered at baseline, 1 month, and 6 months for patients, or at inclusion, 1 month and 30 months for APs and healthcare professionals. Outcomes include quality of life (EORTC QLQ-C30), psychological well-being (HADS), empowerment (CASE-Cancer), care experience (PPE-15), patient-professional relationship (CADICEE), and professional perceptions of APs integration. Qualitative data will be gathered through semi-structured interviews, non-participant observations of meetings, and document analysis. This will explore the experiences of patients, APs, and professionals; the organizational adaptations and, the ethical and professional considerations associated with the program. Implementation fidelity, contextual adaptations, and stakeholders’ engagement will be systematically assessed. This study will provide an in-depth understanding of the integration processes and impacts of peer-support interventions in oncology care. By examining both patient-centered outcomes and organizational dynamics, it aims to identify key factors that facilitate sustainable integration of APs into clinical practice. Findings will inform strategies for scaling up and adapting peer-to-peer support programs across diverse healthcare settings, contributing to the strengthening of patient partnership and participatory approaches in cancer care. Trial is registered under Clinical Trails Registry – France (NCT06817655), registered on 10th February 2025.
PURPOSE:Stroke survivors and caregivers often lack support during the hospital-to-home transition, affecting psychosocial recovery. We assessed the feasibility and acceptability of a patient-centered transition program focused on psychosocial recovery. METHODS:A pilot randomized controlled trial compared a transition program (combining an information platform and case manager follow-up) with usual care. The feasibility and implementation of the intervention were evaluated according to Medical Research Council recommendations. Acceptability, adaptability and satisfaction were studied in the intervention group during semi-structured interviews. RESULTS:28 stroke survivors and 9 caregivers completed the program. All participants in the intervention group attended at least 3 of the 4 scheduled follow-ups with the case-manager, validating the feasibility and acceptability of the program. Overall, 11 of 15 participants consulted the platform, with the maximum number of views on the "administrative procedures" page. The needs expressed during the case manager follow-ups were 39.1% social, 33.7% medical, and 27.2% psychological. Participants expressed satisfaction with the support and information they received. However, few caregivers took advantage of the support offered. CONCLUSIONS:Findings indicate that the Navistroke transition program is feasible and acceptable for stroke survivors and caregivers and helped optimize before assessing its efficacy in a larger trial. REGISTRATION:NCT05928832 https://clinicaltrials.gov/study/NCT05928832?term=NCT05928832&rank=1.
Abstract Background and aims Stroke survivors and their caregivers face lack of support and information increasing their psychosocial burden. We developed and evaluated the Navistroke post-stroke transition program to improve post-stroke participation. We aimed to test the feasibility of involving stroke survivors and caregivers and describe the process and the impact on research. Methods The project was underpinned by the Medical Research Council guidance and the Montreal model for patient engagement. It comprised 3 steps with increasing levels of involvement. Step1 followed a user centered design approach to codesign the intervention through workshops and consultations to test early prototypes. Step2 involved a feasibility study using consultation method to assess acceptability. Step3 assessed the impact of the program, in collaboration with a patient committee that guided the key methodological choices and overall project direction. Results The involvement levels of stroke survivors evolved across the 3 steps. In step 1, 6 stroke survivors and 6 caregivers fully co-designed the intervention to ensure that it reflected post-discharge needs. In step 2, 15 stroke survivors and 5 caregivers shared their experiences to refine the intervention and research project. In step 3, involvement shifted to co-decision, with the creation of a patient committee reviewing study outcomes, guiding measurement choices, and informing intervention delivery. Conclusions Stroke survivor involvement is feasible and valuable at every stage of a research project and should be actively considered by researchers. Although continuous involvement can be challenging, using different levels of engagement offers feasible ways to meaningfully integrate patients throughout the process. Conflict of interest Marion Delvallée: nothing to disclose; Mathilde Marchal: nothing to disclose; Anne Termoz: nothing to disclose; Ouazna Habchi: nothing to disclose; Laurent Derex: nothing to disclose; Anne-Marie Schott: nothing to disclose; Julie Haesebaert: nothing to disclose
OBJECTIVES:Accompanying Patients (APs) are individuals with lived experience of cancer who provide emotional, informational, and navigational support to patients. However, peer-to-peer support interventions in oncology remain inconsistently developed and rarely integrated into clinical practice in France. This study aims (1) to co-design a context-sensitive peer-to-peer support intervention for oncology units, (2) to identify institutional enablers and barriers to implementation, and (3) to develop tailored implementation pathways using implementation science frameworks. METHODS:A multi-site participatory study was conducted in nine oncology units across four French healthcare institutions. Eight patient partners were involved as co-researchers contributing to study design, facilitation of co-design workshops, and iterative model refinement. A structured co-design methodology guided four interactive workshops per unit. Data were collected through workshop materials, observation notes, and co-researcher reflections, and analyzed thematically using the Consolidated Framework for Implementation Research (CFIR) framework, and the resulting intervention was described using the Template for Intervention Description and Replication (TIDieR). RESULTS:Twenty workshops involving 60 stakeholders (APs, healthcare professionals and managers) resulted in the co-construction of a peer-to-peer support model aligned with local care structures. Three key outputs emerged: (1) a shared definition of the APs role, including expected psychosocial competencies and training needs; (2) identification of institutional enablers and barriers to implementation, such as leadership support, physical environment constraints, and role legitimacy; and (3) tailored implementation pathways, including onboarding, supervision, and integration into care processes. The resulting PaRole OncO France (PROOF) model was designed to be adaptable while preserving core components. CONCLUSION:This study demonstrates the feasibility and value of co-designing a peer-to-peer support intervention in oncology, grounded in lived experience and local context. PRACTICE IMPLICATIONS:The PROOF model offers a replicable framework for integrating APs into cancer care teams. Findings provide actionable guidance for institutions seeking to implement sustainable, patient-partnered peer-to-peer support programs.
BACKGROUND:Patient and public involvement (PPI) in research is required to improve the relevance, feasibility, and interpretability. However, research on PPIs in pharmacoepidemiology (PE) is still limited. This study aimed to provide an overview of PPI implementation in pharmacoepidemiology through an environmental scan. METHODS:The environmental scan combined systematic reviews and expert interviews. A systematic review was conducted in MEDLINE, EMBASE, and the Cochrane Library from January 1, 2010, to June 30, 2023, to identify PE studies in which PPIs were mentioned. An additional review covered British Medical Journal's (BMJ) original articles from January 1, 2019, to June 30, 2023, via a similar method. In parallel, a cross-sectional study was conducted with a standardized questionnaire for French PE research teams, involving interviews via videoconference. RESULTS:We identified 3615 references for screening, among which 232 were selected for full-text screening. However, no studies have reported the use of PPIs in PE studies. The additional BMJ review identified 1058 references, 74 of which met the full-text selection criteria, and eight were included. Of 13 French PE research teams surveyed, three had prior PPI experience, and 12 affirmed the relevance of PPI in PE. The respondents identified barriers such as PE's complexity (n = 9). They suggested training for patients (n = 9) and collaboration with specialist teams (n = 5) to facilitate PPI. CONCLUSION:Our environmental scan highlighted the emergence and relevance of PPIs in PE studies, even though they are still uncommon. Tools are needed to acculture and assist PE researchers in engaging in PPIs.
OBJECTIVE:Acute symptomatic seizures (ASyS) occur in up to 30% of patients with intracerebral hemorrhage (ICH) when continuous electroencephalography (cEEG) is used, potentially worsening outcomes. Identification of early EEG biomarkers of ASyS may help guide personalized antiseizure medication (ASM) prophylaxis. Here, we aimed to describe early interictal EEG patterns, their dynamics, and their association with seizure risk, considering the effect of prophylactic levetiracetam. METHODS:This prospective analysis used data from the PEACH phase 3 trial (2017-2020), which enrolled adults with acute spontaneous supratentorial ICH, randomized to receive levetiracetam or placebo. Patients underwent systematic 48-h cEEG within 48 h of symptom onset. Electrographic seizures and interictal EEG patterns were analyzed using standardized terminology of the American Clinical Neurophysiology Society. Associations between rhythmic and periodic patterns (RPPs) and seizures with clinical and radiological variables were assessed using univariate analyses. We also conducted exploratory testing of the CAV (cortical involvement, age < 65 years, volume > 10 mL) score for predicting ASyS, incorporating RPPs and ASM exposure. RESULTS:Forty-two patients were included (median [Q1-Q3] age = 72 [60-79] years, 29% women), 19 in the levetiracetam group. Interictal EEG abnormalities were common and not influenced by ASM, including background asymmetry (73%), sporadic epileptiform discharges (62%), and RPPs (52%). RPPs were associated with ICH volume (p = .039) and cortical involvement (p = .003). Among patients with RPPs, 50% developed ASyS (20% in those treated with ASM vs. 75% in untreated patients, p = .030). Most patients (91.7%) with seizures had RPPs that preceded seizures, in >90% cases by 12 (Q1-Q3 = 4-25) h. Integrating RPPs into the CAV model led to an improvement of ASyS prediction (area under the curve = .949 vs. .918, p = .53) that was statistically nonsignificant. SIGNIFICANCE:RPPs are strong markers of ictogenesis in acute ICH and precede ASyS, thus offering a potential therapeutic window. These findings support the use of early cEEG for risk stratification and personalized ASM prophylaxis.
BACKGROUND:Adherence to post-stroke secondary prevention medications mitigates recurrence risk. This study aimed to measure adherence to secondary prevention medications during 3 years post-ischemic stroke/transient ischemic attack, using prescription and dispensing data, and identify factors associated with suboptimal adherence. METHODS:This multicenter, prospective, cohort study involved patients from the STROKE 69 cohort, which included all consecutive patients with suspected acute stroke admitted between November 2015 and December 2016 to any emergency department or stroke center in the Rhône area in France. Prescription data for antihypertensive agents, antidiabetic agents, lipid-lowering drugs, and antithrombotics were collected. Dispensing data were provided by the French regional reimbursement database. Adherence was calculated using the continuous medication acquisition index. Associations between suboptimal adherence and potential influencing factors across the World Health Organization's five dimensions were explored through univariate and multivariate analyses. RESULTS:From 1512 eligible patients, 365 were included. Optimal adherence to overall treatment (≥90%) was observed in 61%, 62%, and 65% of patients in the first, second, and third years, respectively. Education level (high school diploma or higher: OR = 3.24, 95% CI [1.49; 7.36]) and depression (Hospital Anxiety and Depression Scale-Depression scores 8-10: OR = 1.90, 95% CI [1.05; 3.44]) were significantly associated with suboptimal adherence. CONCLUSIONS:Overall adherence to secondary prevention medications was fairly good. Having an initial diagnosis of transient ischemic attack, a high level of education, or depression was associated with increased odds of suboptimal adherence, while having a history of heart rhythm disorder was associated with lower odds.
Study Objective: The present study is aimed at providing an assessment of the changes in burnout, job strain, isostrain, sleepiness, and fatigue levels over time and identifying factors associated with these symptoms among healthcare workers in French emergency departments (EDs). Method: We conducted a prospective, multicenter study in four EDs and an emergency medical service. Participants completed questionnaires at inclusion and at 90 days to assess burnout, job strain, isostrain, sleepiness, and fatigue. Results: A total of 211 respondents (43.5%) completed the questionnaires at inclusion. At the beginning of the study, 84 (40.8%) participants presented symptoms of burnout, 86 (43.2%) had symptoms of job strain, and 58 (29.4%) of isostrain. Forty-two (20.1%) healthcare workers presented symptoms of sleepiness, and 8 (3.8%) had symptoms of fatigue. We found that symptoms of burnout were more frequent for healthcare workers with a previous psychiatric history (55.3% vs. 39.1%, p = 0.02) and were lower among participants who had at least one dependent child (33.1% vs. 48.3%, p = 0.013). Symptoms of job strain were higher among administrative staff compared to physicians (55.6% vs. 28.7%, p = 0.01) and among healthcare workers with managerial responsibilities compared to those without (45.6% vs. 28.8%, p = 0.015). Symptoms of isostrain were higher among administrative staff (42.3%) compared to paramedics (34.1%) and physicians (19.8%, p = 0.026). Conclusion: We identified that potential factors associated with the emergence of symptoms of burnout and job strain are suggested, underlining several areas of improvement for the prevention against mental health disorders in the specific population of ED healthcare workers. Trial Registration: ClinicalTrials.gov identifier: NCT04383886.
Background During the hospital-to-home transition, stroke survivors and their caregivers face a significant lack of support and information which impacts their psychosocial recovery. We aimed to co-design a program combining individual support by a trained case-manager (dedicated professional providing individual support) and an online information platform to address needs of stroke survivors and caregivers. Methods A two-step methodology was used. The first step followed a “user-centered design” approach during four workshops with stroke survivors, caregivers, and healthcare professionals to develop the platform and define the case-manager profile. The second step was a usability test of the platform following a Think Aloud method with patients and caregivers. The workshops and interviews were analyzed following a qualitative thematic analysis. The analysis of Think Aloud interviews was based on User Experience Honeycomb framework by Morville. Results Eight participants attended the workshops: two patients, two caregivers, three nurses, and a general practitioner. Activities, training, and skills of the case-manager were defined according to stroke survivors and caregivers needs. Name, graphics, navigation, and content of the platform were developed with the participants, a developer and a graphic designer. The usability of the platform was tested with 5 patients and 5 caregivers. The Think Aloud confirmed satisfaction with graphics and content but a need for improvement regarding the navigability. An update of the platform was conducted in order to answer the needs expressed by participants. Conclusion We developed, with a participatory approach, a patient-centered transition program, which will be evaluated in a randomized controlled trial.
Introduction The decisions of withholding or withdrawing life-sustaining treatments are difficult to make in the context of emergency departments (EDs) because most patients are unable to communicate. Relatives are thus asked to participate in the decision‐making process, although they are unprepared to face such situations. We therefore aimed to develop a standardised intervention for announcing decisions of withholding or withdrawing life-sustaining treatments in EDs and assess the efficacy of the intervention on the stress of relatives.Methods and analysis The DISCUSS trial is a multicentre stepped-wedge cluster randomised study and will be conducted at nine EDs in France. A standardised intervention based on human simulation will be codesigned with partner families and implemented at three levels: the relatives, the healthcare professionals (HCP) and the EDs. The intervention will be compared with a control based on treatment as usual. A total of 538 families are planned to be included: 269 in the intervention group and 269 in the control group. The primary endpoint will be the symptoms of post-traumatic stress disorder (PTSD) at 90 days. The secondary endpoints will be symptoms of PTSD at 7 and 30 days, diagnosis of PTSD at 90 days and anxiety and depression scores at 7, 30 and 90 days. Satisfaction regarding the training, the assertiveness in communication and real-life stress of HCPs will be measured at 90 days.Ethics and dissemination This study was approved by the ethics committee Est III from Nancy and the French national data protection authority. All relatives and HCPs will be informed regarding the study objectives and data confidentiality. Written informed consent will be obtained from participants, as required by French law for this study type. The results from this study will be disseminated at conferences and in a peer-reviewed journal.Trial registration number NCT06071078.
Background After discharge home, stroke survivors and their informal caregivers face a significant lack of support and information which accentuates their psychosocial burden. Online resources might provide this support and address psychosocial needs, but existing online stroke programmes mainly target functional rehabilitation. We aimed to map the existing literature on online resources that have been evaluated in stroke rehabilitation and aimed at reducing psychosocial impact in stroke survivors and informal caregivers. Methods MEDLINE was searched (2010–2024) to identify studies investigating online resources targeting psychosocial health. Studies were selected and extracted independently by two reviewers. We described the content, use, and psychosocial impact of these interventions using a narrative approach. Results Eleven studies were included in the review, reporting 10 online resources (two studies relating to the same resource). Online resources were heterogeneous: eight information/resources websites, one mobile app, and one forum. Five online resources were dedicated to stroke survivors, four to stroke survivors and their informal caregivers, and one to informal caregivers. Two randomized controlled trials reported a significant decrease in depressive symptoms associated with the use of online resources. Stroke survivors and informal caregivers find online resources useful and acceptable to address their psychosocial needs. Conclusions Few online stroke resources have been designed and evaluated to support post-stroke psychosocial rehabilitation. Further larger-scale research needs to study the impact of these interventions on psychosocial recovery over time.
Abstract Introduction Mental health in the workplace is a public health issue. Participatory development in health program planning is recommendend to develop complex interventions. The aim was to develop a workplace-based Mindfulness Meditation program (MMP) adapted to a university hospital in France. Methods Following the Intervention Mapping protocol, a taskforce gathering 24 hospital professionals (doctors, paramedics, supervisors, administrative staff) and 10 scientists (researchers and meditation experts) was set up in May 2022 at Lyon University hospital. The needs assessment involved a literature review and 12 individual interviews with hospital professionals. The program’s logic model was developed during 4 participative workshops (with an initiation to meditation practice) with stakeholders. A qualitative content analysis was carried out with MAXQDA. Results The qualitative analysis highlighted important dimensions, such as lack of time, psychosocial hazards, leadership, teamwork, and representations of meditation. A MMP was developed to fit the hospital context. A meditation group of 15 professionals per department (all job categories, including management) will attend 10 collective practice sessions (1h) over 3 months. sessions are considered as working hours although positioned outside the department’s operating schedule (continuity of care). A stepwise recruitment will proceed through information and experience of meditation prior to enrollement on a voluntary basis. Discussion The participatory process revealed several barriers and facilitators enabling to develop a program adapted to the context, increasing its relevance and acceptability. Conclusion The program’s evaluation will proceed with a cluster randomized trials (8 departments) combined with a realist evaluation of the effects produced by the mechanisms activated according to the context.
(1) Background: A substantial proportion of COVID-19 patients continue to experience long-lasting effects that hamper their quality of life. The objectives of this study were (1) to report the prevalence of persistent clinical symptoms 6–12 months after the onset of COVID-19 and (2) to identify potential factors at admission associated with the occurrence of long COVID. (2) Methods: A prospective study was conducted among COVID-19 adult patients, hospitalized in four French university hospitals. Patients were invited to two ambulatory follow-up medical visits, 6–8 months (visit #1) and one year (visit #2) after the onset of their COVID-19. A multivariate logistic regression was performed to assess factors associated with long COVID. (3) Results: In total, 189 patients participated in this study (mean age of 63.4 years). BMI > 30 kg/m2 (aOR 3.52), AST levels between 31 and 42 U/L (aOR 8.68), and AST levels > 42 U/L (aOR 3.69) were associated with persistent clinical symptoms at visit #1. Anosmia (aOR 13.34), AST levels between 31 and 42 U/L (aOR 10.27), stay in ICU (aOR 5.43), pain (aOR 4.31), and longer time before hospitalization (aOR 1.14) were significantly associated with persistent clinical symptoms at visit #2. Patients with ageusia (aOR 0.17) had a lower risk of long COVID. (4) Conclusions: This study showed that some patients experienced persistent clinical symptoms one year after COVID-19 onset that were associated with some determinants at the acute phase/stage.
BACKGROUND:Post-stroke social participation is a major determinant of quality of life and life satisfaction. However, few data relating to participation determinants are available, especially the influence of psychological factors and factors related to the living environment.OBJECTIVES:This study investigated determinants of post-stroke social participation within the International Classification of Functioning, Disability and Health framework.METHODS:We contacted people with stroke who had been hospitalized in the Rhône County, included in a previous cohort study, were aged ≥18 years and were not institutionalized. The primary outcome was social participation measured with the Stroke Impact Scale (SIS) 2.0. We performed multiple hierarchical linear regressions to test the following predictors: clinical factors (stroke-related variables, limitations in Activities of Daily Living [ADL]/Instrumental ADL), personal factors (sociodemographic factors, coping strategies) and environmental factors (satisfaction with social relationships and living environment).RESULTS:Among the 352 participants, 63% were men, and mean age was 68.7(SD 14.5) years. In the last multivariate model, variables associated with higher levels of social participation were the use of the positive thinking coping strategy (B (SD)=1.17(0.52), p = 0.03), higher perceived satisfaction with the living environment (B (SD)=0.17(0.07), p = 0.03) and fewer perceived activity limitations (B (SD)=0.55 (0.06), p < 0.001). Conversely, the seeking social support coping style (B (SD)= -1.98 (0.60), p = 0.001), and a higher number of stroke-related sequelae (B (SD)= -1.93(0.53), p = 0.001) were associated with lower social participation.CONCLUSIONS:The identification of potentially modifiable personal and environmental factors that influence social participation provides elements to strengthen existing rehabilitation programs and opens the way for possible psychosocial interventions.