Conectar
To explore the impact of acute worsening events (AWEs), defined as clinically relevant deteriorations in peak expiratory flow, reliever use and/or symptoms, on patients’ daily lives and identify behaviours linked to their recognition and management.
A qualitative international substudy was conducted in the Netherlands, Spain, the USA, Canada and the UK (2023–2024).
19 patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) from a randomised clinical trial participated. Interviews, triggered by AWEs and repeated 6 weeks later, were audio-recorded, transcribed and analysed.
Patients varied in identifying bad days, reporting inability to perform physical activities, symptom worsening or the need for add-on treatment. Recognition of AWEs depended on their duration: shorter events (
AWEs significantly impact daily life but vary widely in recognition and thresholds for seeking care. Limited awareness of daily disease variations may contribute to both under-reporting of worsening events to healthcare providers and suboptimal self-management in COPD.
The interaction between the gut microbiota and the host immune system is implicated in the pathogenesis of inflammatory bowel disease, including ulcerative colitis (UC). Targeting the gut microbiota with faecal microbiota transplantation (FMT) from a healthy donor has shown promise in inducing remission in patients with active UC. However, mixed results and protocol heterogeneity have limited its practical application. Our previous Transfer of Faeces in Ulcerative Colitis; Restoring Homeostasis (TURN) trial found a correlation of clinical response with specific strains and butyrate production. Since most gut microbes, including many butyrate producers, are anaerobes, anoxic processing of donor stool may be essential to increase efficacy of FMT in UC. This trial aims to enhance FMT efficacy by applying strict anoxic processing, selecting donors based on microbial composition and using repetitive dual-route administration.
This randomised, double-blind, placebo-controlled, multicentre study evaluates the efficacy of strictly anoxic prepared donor FMT compared with anoxic prepared autologous FMT in patients with mild to moderate active UC. An open-label extension option is available for non-responders in the autologous arm. Included patients will receive 4 weekly FMTs, comprising two double-route administrations (nasoduodenal administration combined with enema) and two single enemas. Donors are selected based on their microbiota profile, informed by our previous TURN trial and literature. A total of 76 patients evaluable for the primary endpoint will be included. The primary endpoint is steroid-free clinical and endoscopic remission at week 8, assessed by the adapted Mayo score. An interim analysis will be conducted midway through the study by a Data Safety Monitoring Board to monitor efficacy and safety. Other outcomes of this study include the evaluation of clinical, endoscopic and histological response. In addition to clinical results, this study aims to provide valuable insights into specific microbial strains, metabolites and mechanisms correlated with response, aiding in the development of future microbial therapies.
Ethics approval was obtained from the medical ethics committee of the Amsterdam University Medical Centre in the Netherlands (reference number 2018_057). All participants will provide written informed consent. The results of the trial will be disseminated through publication in a peer-reviewed journal and presentations at (inter)national conferences.
Prospectively registered in May 2018 in the Dutch Trial Register (NTR/LTR) as NL7770. Assigned NL-OMON52507 following the transition of the Dutch Trial Register to the Overview of Medical Research in the Netherlands. Also registered at ClinicalTrials.gov (NCT05998213).
Shared decision making (SDM) is advocated as an approach for patient-centred asthma care. However, this approach may not always be feasible or preferred by patients and/or healthcare professionals (HCPs). Knowledge and insights into whether and how the preferred collaboration style in medical decision making is discussed and managed during consultations for severe asthma are limited.
To investigate how HCPs’ and patients’ preferred collaboration styles in treatment decision making are experienced, discussed and managed during consultations.
Qualitative research using semi-structured interviews with HCPs specialised in severe asthma and a focus group with severe asthma patients in The Netherlands. Inductive thematic analysis was used, with results reported according to the COREQ checklist.
Four themes concerning HCPs’ and patients’ experiences were identified: (1) overall preference for SDM, yet (2) ambiguity of SDM’s content, (3) variation in application of SDM and (4) friction between medical focus and patient autonomy in SDM. A fifth theme concerned the discussion and management of collaboration style preferences: limited metacommunication. HCPs and patients seem unable to identify each other’s preferences in collaboration styles. Overall, a lack of communication regarding how to collaborate in making treatment decisions was found. Varying views on meaning and content of collaboration styles, especially SDM, and HCPs’ medical focus seemed to contribute to the lack of communication.
With the lack of communication regarding preferences in collaborating, HCPs and patients are likely to miss out on effective collaboration. Future studies should explore how views and preferences regarding HCP-patient collaboration can be bridged.
To better develop and understand the practice of rooming-in in adult care, this study aims to explore the perceptions of the three most important stakeholders: nurses, patients, and family members.
A cross sectional survey study in a university medical centre in the Netherlands.
A convenience sample was drawn from nurses, adult patients, and family members across ten general wards. Data of patients and family members were collected through online questionnaires, developed and validated prior to the study. Their responses were summarised using descriptive statistics. For the nurses, data were obtained by analysing responses to an open-ended question from an existing questionnaire, using thematic analysis.
The sample consisted of 364 nurses, 26 patients, and 35 family members. Thematic analysis of the nursing data revealed four themes: (1) reducing the workload of nurses, (2) optimising patient recovery, (3) unclear policy and inadequate facilities, and (4) complexities for nurses. Regarding the perceptions of patients and family members, more than 75% perceived that rooming-in enhanced patients' sense of safety. Additionally, 54.1% of family members indicated that rooming-in improved their understanding of medical information. For most patients (57.7%) and family members (62.9%), the rules and conditions for rooming-in were not clear. Moreover, 65.7% of family members reported experiencing physical burden. Both patients and family members rated rooming-in with a median of 8 out of 10.
According to nurses, patients, and family members, rooming-in may be beneficial in reducing nurses' workload, enhancing patient safety, and improving family understanding of medical information.
Given the ambiguity surrounding rooming-in policies in adult care, clear guidelines and their implementation are essential for ensuring their success.
Rooming-in can positively contribute to adult care by facilitating family involvement.
STROBE statement.
No patient or public contribution.
To explore the motivations, barriers and potential solutions from professionals’ perspectives for achieving effective interdisciplinary practice, focusing on communication and collaboration to support work participation and facilitate patients’ return-to-work (RTW).
Qualitative exploratory interview study using thematic analysis.
Primary and work-focused healthcare.
22 healthcare professionals, including occupational physicians (n=5), social insurance physicians (n=5), general practitioners (n=7) and occupational physiotherapists (n=5), were purposively recruited. All participants had at least 1 year of experience and were actively involved in patient care.
None.
Identified motivations, experienced barriers and proposed solutions for improving communication and collaboration across disciplines in work-focused healthcare.
Participating healthcare professionals emphasised the importance of early, proactive and person-centred communication across care domains, particularly in complex or stagnating RTW trajectories. Key barriers included a lack of shared knowledge and common goals, limited understanding of each other’s roles, time constraints, fragmented systems and regulatory restrictions. Proposed solutions focused on clearer coordination of care, improved role clarity and development of a secure, cross-domain digital communication platform to streamline information exchange.
Effective work-focused healthcare requires improved interprofessional communication and patient-centred collaboration. This study highlights when collaboration is most valuable, identifies key barriers and outlines feasible practical solutions. Future research should focus on developing and implementing guidelines that clarify communication pathways and coordination mechanisms within interdisciplinary teams.
Providing an overview of the organisation, tasks, and responsibilities of acute and transitional pain services in the Netherlands.
Cross-sectional questionnaire study.
An online questionnaire was sent to representatives of Dutch hospital pain services performing inpatient surgery. It included items on organisation, staffing, education, roles, tasks and responsibilities. Data were analysed descriptively.
Of the surveyed hospitals, 92.2% reported having an acute pain service, while only 6.5% had a transitional pain service. Most pain services (acute pain services 76.3%, transitional pain services 80.0%) are part of the anaesthesiology department. Staffing includes anaesthesiologists, nurses, and/or nurse anaesthetists, with or without pain specialisation. Acute pain service teams monitor complex pain management techniques. Nearly all acute pain services (89.8%) provide pain management training, and 60% monitor hospital-wide pain management quality. All transitional pain services monitored opioid use post-discharge and conducted follow-up calls with patients.
Acute pain services are well established in Dutch hospitals, whereas transitional pain services remain limited. Organisational structures, tasks, and responsibilities vary, with key challenges in staffing, service organisation, and education. Future research should focus on optimising staffing, expanding transitional pain services, the role of the pain nurse, and establishing a national pain management education framework.
This study highlights the significant impact of pain nurses as a central professional within the interdisciplinary team, contributing to quality care and education, ultimately benefiting patients.
This study provides a current overview of pain services in the Netherlands, supporting pain nurses in innovating pain services, highlighting key challenges and opportunities for improvement.
STROBE checklist.
None.
The Circle of Security-Parenting (COS-P) group intervention has demonstrated efficacy in reducing maternal perinatal mental health difficulty (PMHD) symptoms in some contexts. The Circle of Security Intervention (COSI) study, a multisite, individually randomised, single-blind, parallel-arm controlled trial, was conducted in England to assess the clinical effectiveness of COS-P in reducing perinatal psychopathology, parenting and infant development, as well as its acceptability among the National Health Service (NHS) participants and staff. The main aim of this work is to estimate the cost-utility of COS-P plus treatment as usual (TAU) relative to TAU among mothers and birthing parents receiving NHS perinatal mental health services (PMHS) in England.
A within-trial economic evaluation was performed comparing COS-P plus TAU with TAU alone, using data from the COSI trial, which employed a 2:1 randomisation ratio. Analyses were conducted from both NHS and personal social services (PSS) and societal perspectives. A 12-month time horizon was used, consistent with the final trial follow-up.
Secondary care NHS perinatal health services across multiple centres in England.
A total of 371 mothers and birthing parents with PMHD were randomised and had complete economic outcome data; 248 received COS-P plus TAU and 123 received TAU alone. Participants were eligible if they were receiving NHS PMHS; exclusion criteria were defined in the trial protocol.
Participants in the intervention arm received the COS-P group programme in addition to TAU. The control group received TAU alone.
The primary economic outcome was quality-adjusted life years (QALYs) over 12 months, derived from the 5-level EuroQol five-dimensional (EQ-5D-5L) questionnaire - responses. Costs were estimated from NHS and PSS as well as societal perspectives, including healthcare utilisation and productivity losses due to work absence.
Compared with TAU, COS-P was associated with higher costs from both NHS and PSS (£180.58; 95% CI –£1075 to £1436) and societal (£72.94; 95% CI –£1473 to £1619) perspectives. COS-P was marginally less effective in terms of QALYs (–0.01; 95% CI –0.06 to 0.05). Probabilistic sensitivity analyses indicated substantial uncertainty around cost and effectiveness estimates.
On average, COS-P was associated with higher costs and did not demonstrate improvements in health-related quality of life compared with TAU alone. Given the uncertainty surrounding the estimates, further research is warranted to explore potential longer term economic and clinical impacts of COS-P in perinatal mental health settings.
SRCTN18308962.
To evaluate the acceptability and feasibility among nurses of Decubitus Risk Prediction Alerts based on Artificial Intelligence (DRAAI), and to assess the feasibility of the implementation plan.
A process evaluation of a pilot implementation study using mixed methods.
Acceptability and feasibility of DRAAI among nurses from three general wards in a university hospital was assessed via questionnaire. The tailored implementation plan included thirteen strategies distributed over six domains, such as facilitation, continuous evaluation, and educational sessions. Adaptations, acceptability, and feasibility were recorded in field notes.
Fifty-five nurses completed the questionnaire and valued DRAAI's predictions, believing these could contribute to pressure ulcer (PU) prevention. Some initially faced challenges distinguishing between PU risk and PU detection. Most found it feasible to integrate DRAAI into their workflow. Adaptations included adding PU preventive measures to educational sessions and sharing frequently asked questions and answers. Overall, implementation efforts were feasible. DRAAI generated PU risk predictions for 428 unique admitted patients; 128 (30%) patients received at least one at-risk prediction. Regarding fidelity, nearly 80% (101/128) of at-risk predictions were followed by a nursing care plan.
Ongoing involvement and clear communication were crucial for successfully integrating AI into nursing workflows. Although some nurses were concerned that DRAAI might miss at-risk patients, they continued to independently identify at-risk patients.
Implementation of DRAAI served as a prompt for nurses to focus more on PU prevention. While DRAAI shows promise in improving PU prevention, future research is needed to evaluate its clinical impact.
Addressed the challenge of identifying patients at risk for developing pressure ulcers. Demonstrated feasibility and acceptability of implementing AI in clinical practice. Highlighted the need for ongoing support and communication for successful implementation.
None.
Standard for Reporting Implementation Studies (StaRI).
To explore maternity care providers’ attitudes toward regional centralisation of vaginal breech birth (VBB) care and gather their recommendations for maintaining clinical proficiency.
Exploratory qualitative study using semi-structured interviews and thematic analysis.
10 hospital-based maternity care professionals (nine obstetricians and one clinical midwife), purposively sampled to represent experience and institutional diversity.
10 hospital maternity units in a metropolitan region of the Netherlands.
Key themes describing provider attitudes towards two proposed models of centralised care (mobile breech team, designated referral centre) and alternative strategies.
Three core themes emerged: (1) proficiency—providers valued regular exposure, formal training and peer support, expressing concern that centralisation would reduce overall workforce readiness; (2) organisation—concerns included unequal access, staffing burden, legal risks and inefficiencies in mobile teams and (3) alternatives—participants preferred a regional breech network with shared training, joint video review and expert on-call support.
Maternity care providers opposed full centralisation of VBB, favouring a networked model that distributes expertise and preserves local access. These insights highlight the importance of involving frontline providers in service redesign.
Not applicable.
by Sanne H. B. van Dijk, Marjolein G. J. Brusse-Keizer, Bente Rodenburg, Anke Lenferink
IntroductionComorbidities significantly complicate COPD management. Remote monitoring could aid real-time disease and symptom management, assisting both patients with multimorbidity and healthcare professionals (HCPs). This study aimed to explore how insight in patterns of symptom deterioration, derived from remote monitoring, could enhance multimorbid COPD management as perceived by patients and HCPs.
MethodsUsing daily symptom data collected via a mobile diary in the prospective RE-SAMPLE cohort study, patterns of symptom deterioration of COPD, chronic heart failure, anxiety, and depression were visualized per patient (follow-up duration of ≥4 months). Semi-structured individual interviews were conducted with Dutch patients with COPD and ≥1 comorbidity, and with HCPs from pulmonology, cardiology, and medical psychology who were involved in care for patients with multimorbidity. Interviews addressed current multimorbid COPD management, its challenges, and the way pattern visualizations of symptoms deterioration could support disease management. Transcripts were thematically analyzed using an inductive approach.
Results7 patients (69–80 years, 4 men) and 7 HCPs were interviewed in the hospital (patients and HCPs), at home (patients) or online (HCPs). Three overarching themes were identified, representing the elements of multimorbid COPD management that could be supported by the pattern visualizations: 1) relationship between diseases, 2) decision-making, and 3) self-management. According to patients and HCPs, pattern visualizations can be an informative source to explain the relation between COPD and comorbidities, function as a conversation starter facilitating communication between patients and HCPs as well as between medical disciplines, and educate patients in adequately recognizing their care needs.
ConclusionThree elements of personalized multimorbid COPD management were identified through qualitative analysis, which can all be supported by visualizing patterns of symptom deterioration via remote monitoring. The visualizations could enhance patients’ understanding of their diseases, improve shared decision-making, improve in-hospital multidisciplinary collaboration, and support multimorbid COPD (self-)management.
by Lian Trapman, Lea M Dijksman, Jan C. Grutters, Saskia C.C.M. Teunissen, Everlien de Graaf
BackgroundProgressive pulmonary fibrosis is a lethal disease with a survival of 3–5 years with optimal medication treatment. Palliative care and advance care planning are therefore receiving increasing attention in the literature. However, structural implementation in clinical practice is still lacking. The aim of this study was to explore the needs, facilitators, and barriers for communication on the topic of end-of-life preferences of patients from the perspective of healthcare professionals.
MethodsA generic qualitative study was performed with focus groups and individual semi structured interviews with healthcare professionals. Data collection and analysis were performed iteratively. A thematic analysis was performed, following the methods of Braun and Clarke.
ResultsThree focus groups and seven individual semi-structured interviews were conducted. Three themes were generated: (1) a lack of vision on palliative care, resulting in different approaches within the same clinic and showing the need for optimization of collaboration; (2) the importance of a learning-driven environment to support healthcare professionals skills and knowledge; and (3), the central role of the individual professional in developing skills and knowledge.
Conclusions/discussionThis study underscores the importance of behavioral and organizational change in palliative care to optimize conversations exploring values, preferences, and needs for end-of-life care for patients with pulmonary fibrosis. Leveraging the shared motivation of healthcare professionals to provide optimal care, integrating these findings into training and coaching programs can further enhance patient-centered approach in palliative care.
In the Netherlands, approximately 2200 major amputations of the lower extremities are performed each year, the majority in vascular patients. Around 61% of these patients will develop postamputation pain (PAP). PAP is a severe, lifelong, disabling condition profoundly affecting quality of life. During amputations, the common practice is to cut the nerves without employing nerve-surgical techniques to prevent chronic pain due to neuroma formation. In recent years, targeted muscle reinnervation (TMR) has been the most frequently studied technique for treating PAP, inhibiting neuroma formation by rerouting the cut mixed nerve to a functional motor nerve. We hypothesise that a primary TMR procedure during major lower limb amputations will result in a lower prevalence of PAP.
We propose a national, multicentre, randomised, sham-controlled trial comparing TMR with traction neurectomy in major amputations of the lower extremities in patients with vascular disease. 203 patients will be recruited with an indication for a transfemoral to transtibial amputation as a primary or secondary sequela of vascular disease. The subjects are randomly assigned to the TMR group or the traction neurectomy group. PAP will be evaluated 1 year postoperatively as the primary endpoint. Secondary outcomes include quality of life, mobility, neuropathic pain, hospital anxiety and depression, cost-effectiveness and complications.
This study has been reviewed and approved by the local ethical review body, ‘The Medical Ethics Committee Leiden The Hague Delft’, under the reference: P24.073 on 28 November 2024. Results will be published in peer-reviewed journals.
NCT06719245. Dutch trial registry: NL87196.058.24
To explore barriers and facilitators for reducing low-value home-based nursing care.
Qualitative exploratory study.
Seven focus group interviews and two individual interviews were conducted with homecare professionals, managers and quality improvement staff members within seven homecare organizations. Data were deductively analysed using the Tailored Implementation for Chronic Diseases checklist.
Barriers perceived by homecare professionals included lack of knowledge and skills, such as using care aids, interactions between healthcare professionals and general practitioners creating expectations among clients. Facilitators perceived included reflecting on provided care together with colleagues, clearly communicating agreements and expectations towards clients. Additionally, clients' and relatives' behaviour could potentially hinder reduction. In contrast, clients' motivation to be independent and involving relatives can promote reduction. Lastly, non-reimbursement and additional costs of care aids were perceived as barriers. Support from organization and management for the reduction of care was considered as facilitator.
Understanding barriers and facilitators experienced by homecare professionals in reducing low-value home-based nursing care is crucial. Enhancing knowledge and skills, fostering cross-professional collaboration, involving relatives and motivating clients' self-care can facilitate reduction of low-value home-based nursing care.
Implications for profession and patient care: De-implementing low-value home-based nursing care offers opportunities for more appropriate care and inclusion of clients on waitlists.
Addressing barriers with tailored strategies can successfully de-implement low-value home-based nursing care.
The Consolidated Criteria for Reporting Qualitative Research checklist was used.
No patient or public contribution.
Physiotherapists recognise the biopsychosocial model as important in treating chronic pain. However, the adoption of this model in Dutch private practice is limited. Participatory action research, including co-design methods and an explicit perspective on workplace learning, may be helpful in developing a work-integrated learning programme to facilitate the use of a biopsychosocial perspective in private practice physiotherapy.
To give insight into the development of a work-integrated learning programme for private practice physiotherapists in assessing and treating patients with chronic pain from a biopsychosocial perspective.
An interprofessional development team of designers, developers, educational professionals and researchers engaged in a co-design process together with private practice physiotherapists, experts in chronic pain, patients and other relevant stakeholders. In this design process, the team developed several prototypes and the subsequent work-integrated learning programme during three 2-week design sprints, living-lab tests and validation sessions. All available co-design data were structured and analysed by three researchers, resulting in a plan of requirements as a foundation for the work-integrated learning programme.
The data rendered two specific outcomes: (1) a plan of requirements to be used as an educational foundation for the work-integrated learning programme and (2) several prototypes based on the underlying principles that are used in the development and validation of the work-integrated learning programme.
This study shows how co-design methods can be successfully applied to generate insights and develop interventions that bridge theory and practice for physiotherapists working in private practice. The designed prototypes and subsequent distilled plan of requirements for the development of a work-integrated learning programme offer new opportunities to facilitate the transition to working from a biopsychosocial perspective in private practice physiotherapy.
RAAK.PUB06.014.
To assess self-reported practices and knowledge of nurses and prescribers (i.e., physicians and nurse practitioners) on intravenous fluid therapy, and to evaluate how this is documented through a clinical documentation review.
Multicentre cross-sectional study, between April 2022 and July 2022, across 13 wards from four Dutch hospitals.
A survey study was conducted to assess self-reported practices related to intravenous fluid therapy. A 12-item questionnaire evaluated knowledge. To gain insights into documentation practices, a retrospective chart review was performed. Data analysis involved descriptive statistics, with group differences analysed using the chi-squared test or Fisher's exact test, as appropriate.
Three hundred and four healthcare professionals completed the questionnaire (92% nurses). The majority of prescribers (n = 20/25; 80%) expected that nurses would start, stop or change intravenous fluid therapy. Overall, the median number of correct answers to knowledge questions was eight (IQR 7–9, range 0–12); four participants (1%) answered all knowledge questions correctly. Knowledge about the composition of sodium chloride 0.9% solution was limited. Analysis of patient charts revealed that 54% (196/362) received intravenous fluids, most commonly 0.9% sodium chloride infusion (168/195; 86%), although the indication was described in 3% (6/196). Thirty-one percent (61/196) of patients received intravenous fluids to keep the vein open (< 30 mL/h).
The study identified shared responsibility, a knowledge gap, and limited documentation concerning intravenous fluids. Prescribers expect nurses to adjust intravenous fluids without consulting a prescriber, which aligns with what nurses do, although they are not legally authorised. Given the limited documentation of the indication for intravenous fluids, it is plausible that several patients received intravenous fluids unnecessarily.
The perceived shared responsibility presents an opportunity to develop a protocol engaging both prescribers and nurses, aiming to guide more targeted infusion therapy.
Reducing unnecessary infusions to keep-the-vein-open can help eliminate low-value care.
CROSS guideline.
No patient or public contribution.
Ventilation tube insertion for paediatric otitis media (POM), including acute otitis media (AOM) and otitis media with effusion (OME), has been signalled in the past for potential unwarranted treatment variation. Quality improvement initiatives, like Audit & Feedback (A&F), often ignore the care pathway when identifying such variation, possibly overestimating variation at a specific care step. To gain more insight into the effect of prior care steps, this study examined (1) the degree of regional variation in each step of the care pathway (general practitioner (GP) contacts, referrals and surgeries) and (2) investigated the effect of adjusting for prior care steps.
Observational study using general practice electronic health record data linked to specialist claims data.
272 790 children ≤12 years with and without POM registered in 320 GP practices between 2017 and 2018.
Using multilevel logistic regression, the degree of regional variation in each step of the POM care pathway was assessed by calculating the coefficient of variation (CV).
The effect of adjusting for prior care steps was determined by estimating correlations between subsequent care steps and analysing the impact on the CV.
Regional variation in POM treatment was larger in each subsequent step in the care pathway (CV POM GP contacts 0.110; referral 0.179; surgery 0.239). In regions with a higher proportion of children with frequent AOM/persistent OME, referral rates were higher (POM: OR: 1.06; 95% CI: 1.02 to 1.11) and surgical rates were higher (for OME only: OR: 1.08; 95% CI: 1.02 to 1.15). Regional variation in referrals and surgery decreased after adjusting for the regional frequent AOM/persistent OME rate (CV referrals POM 0.103 vs 0.128; CV surgery OME 0.047 vs 0.059).
Regional variation is observed in GP contact rates for POM and is larger in referrals and surgeries. Adjusting for the proportion of frequent AOM/persistent OME significantly reduces regional variation in POM treatment. Future A&F should adjust for prior care processes and develop tailored interventions for quality improvement.
Muscle-invasive bladder cancer (MIBC) is an aggressive type of cancer. About 50% of patients will die from the disease within 5 years despite radical treatment. This implies that in many patients, the disease has already spread at the time of radical treatment, even though imaging shows no signs of metastasis. We hypothesise that the standard local staging method, transurethral resection of the bladder tumour (TURBT), is partly responsible for tumour cell spread. Furthermore, TURBT (and re-TURBT in many patients) contributes to a significant delay to definitive therapy. The aim of this randomised study is to determine whether multiparametric MRI (mpMRI) of the bladder, in combination with a single outpatient bladder tumour biopsy for histological confirmation, is a safer, faster, less costly and, therefore, more cost-effective diagnostic pathway than TURBT to detect or rule out MIBC.
BladParadigm is a two-arm multicentre randomised controlled trial (RCT) conducted in the Netherlands. Over a 3-year period, patients with clinically suspected MIBC without evidence of metastases will be recruited and randomised 1:1 to either TURBT or 3-Tesla mpMRI with same-day outpatient bladder biopsy. The Vesical Imaging Reporting and Data System (VI-RADS) will be used to standardise mpMRI reporting. Patients will undergo definitive treatment based on the results of the TURBT or mpMRI. The study is powered to demonstrate that the mpMRI-based strategy is at least non-inferior to standard TURBT in patients treated with radical cystectomy alone, assuming a relative hazard of 0.55. The required sample size is 360 patients (180 TURBT, 180 mpMRI). The primary outcome is 2-year progression-free survival. Progression will be assessed by imaging, according to the current standard of care. Secondary outcome measures are time to definitive treatment, quality of life (EuroQol 5D-5L), healthcare costs and cost-effectiveness.
This study has received ethical approval from the Medical Ethical Committee Oost-Nederland (NL83685.091.23). All participants will provide written informed consent prior to inclusion. Findings of this study will be disseminated through peer-reviewed, open-access publications, presentations at scientific conferences and stakeholder briefings.
To investigate the effects of active involvement of family caregivers in adult in-hospital care on patients' readmissions, complications, mortality, length of hospital stay, quality of life, psychological distress and activities of daily living, as well as on the satisfaction of patients, HCPs and family caregivers.
Systematic review.
Ovid Medline, Ovid Embase, EBSCO CINAHL, Cochrane Library (from inception to February 2024).
The PRISMA 2020 statement was followed. Prospective controlled studies focusing on active involvement of family caregivers in adult in-hospital care were included. Two independent teams of authors conducted study selection, quality assessment and data extraction.
Thirteen studies were included, comprising 11 randomised controlled trials. The clinical and methodological heterogeneity precluded a meta-analysis. Six of these studies were performed in stroke patients. Some studies reported statistically significant benefits of active family involvement on readmission rates, hospital LOS, ADL, psychological distress for patients and family members, QoL and satisfaction of family caregivers. However, others did not observe differences in these outcomes. For complication rates, mortality and satisfaction of patients and HCPs, no studies demonstrated significant differences between groups.
Further research is needed to provide a conclusive answer as to whether active family caregiver involvement improves outcomes of adult hospitalised patients.
Despite the inconclusive findings of this review, advocating for active involvement of family caregivers in adult in-hospital care fits the perspective of patient- and family-centred care.
As the care of hospitalised adults is shifting to a more family-centric approach, investigating the effects of an active role of family caregivers in adult in-hospital care is necessary. However, the small number of studies available and heterogeneity between studies included in this review hamper firm conclusions. Further evaluations through well-designed studies are required.
Body contouring surgery (BCS) can be applied to reduce the physical and mental burden of excess skin after massive weight loss. Self-reported outcomes of patients are used to assess this burden and to evaluate the effectiveness of BCS. The aim of this study is to clarify what is reflected in self-reports of excess skin after bariatric surgery. We hypothesise that the self-reported burden of excess skin is associated with both objectively assessed excess skin and the disposition to experience negative emotions.
This cross-sectional study will include 68 outpatients presenting at a plastic surgery clinic with a request for BCS. Patients fill out two questionnaires (the BODY-Q and the Sahlgrenska Excess Skin Questionnaire (SESQ)) to measure the size and burden of excess skin as well as the Big Five Inventory (BFI) to measure the disposition towards negative emotionality. Anonymised photographs of excess skin will be rated independently by four plastic surgeons using the Pittsburgh Rating Scale (PRS) Rainbow Classification to establish the objective amount of excess skin. Multiple linear regression analyses will be performed to identify the association of BODY-Q and SESQ scores with objective appraisals of excess skin by plastic surgeons, negative emotionality and demographics. Interobserver agreement for PRS Rainbow Classification will be established by Fleiss’ kappa.
Ethical approval was obtained from the regional medical ethics committee (METC; W20.258) and the institutional review board (Lokale Toetsing, St. Antonius Hospital in Nieuwegein, no. Z23.035). Informed consent of participants will be obtained. The results of this study will be submitted for publication in a peer-reviewed journal.
FreshRSS 