Systemic sclerosis (SSc) is an autoimmune disorder causing progressive fibrosis of internal organs and skin, leading to increased thickness and rigidity. It frequently results in malnutrition, which can decrease survival rates and physical performance, while also imposing financial burdens on healthcare systems and society. Multimodal nutritional interventions may encompass various approaches, including nutritional counselling, consumption of oral nutritional supplements and disease-specific dietary regimens based on nutritional needs. The present clinical trial is designed to examine the effectiveness of multimodal nutritional intervention on nutritional status, quality of life, food intake, body composition and fatigue in patients with SSc.

This is a parallel, randomised, placebo-controlled clinical trial that will investigate the impacts of multimodal nutritional interventions in SSc patients. 46 qualified SSc participants will be chosen at random and given multimodal nutritional intervention or dietary recommendations for a period of 8 weeks. The primary outcomes of this study are changes in nutritional status and quality of life. The secondary outcomes include changes in body composition, fatigue, body weight, body mass index and calf circumference. Statistical analysis will be conducted using the SPSS software (Version 24).

The current trial received approval from the Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.MEDICINE.REC.1403.345). The findings will be submitted to international, peer-reviewed publications and presented at national and international conferences.

IRCT20220208053971N4.

The Core Outcome Measures for Improving Dementia Care (COM-IC) project aims to develop a core outcome set for measuring the quality of care provided to people living with dementia in routine care settings. In a previous stage of the project, 17 core outcomes were identified. This study is the next step, aiming to review the literature to identify existing or recommended, validated scales for measuring the identified core outcomes.

A rapid review

Six electronic databases (PubMed, Embase (Elsevier), CINAHL Complete (EBSCOhost), APA PsycINFO (EBSCOhost), Web of Science (Clarivate) and Scopus (Elsevier) were searched. Searches were completed on 12 July 2024.

Peer-reviewed systematic reviews or original validation studies of scales measuring dignity; engagement in advance care planning; pain; quality of life; feeling safe and secure; emotional well-being; diagnosis of dementia; behavioural and psychological symptoms of dementia; the importance of relationships; meaningful activities; hygiene and comfort; resource utilisation and safety incidents for people living with dementia were included. Peer-reviewed systematic reviews or original validation studies of the scales to measure informal carers’ quality of life, their educational opportunities, formal carers’ morale and dementia-specific qualifications were also included. All studies were required to have been conducted among people living with dementia or carers, as appropriate, and to have full texts available in English.

Data on the scale’s name, the number of subscales, subscales’ names, the number of items, response options, scoring, estimated time to complete the scale, recommended frequency of data collection and the setting where the scale was first validated were extracted. Findings are presented in figures, tables and narrative texts.

A total of 88 validated scales were identified. No scales measuring dignity, engagement in advance care planning, feeling safe and secure, hygiene or safety incidents were validated for people living with dementia. No scale was identified to measure the importance of relationships for people living with dementia, the formal carers’ dementia-specific qualifications or the educational opportunities for informal carers. The review also describes the 50 recommended or validated scales.

Several validated or recommended scales exist to measure core outcomes identified as important for assessing the quality of care provided to people living with dementia in routine care settings. This review offers COM-IC stakeholders and other potential users with information on the validated/recommended scales to measure these core outcomes.

Our objective was to examine the barriers and facilitators encountered by primary and secondary healthcare professionals when collaborating at the care continuum between primary and secondary care. We aimed to identify specific challenges, observed benefits and proposed changes. By analysing these experiences and identifying opportunities for redesign, we aimed to define specific domains that could improve collaboration, thereby supporting sustainable access to and quality of care in the face of rising demand and constrained resources.

A qualitative exploratory study using semi-structured interview data guided by two domains of the Consolidated Framework for Implementation Research (CFIR), including Inner Setting—Tension for Change and Individual Characteristics, as well as selected implementation outcomes defined by Proctor et al, all viewed through a service (re)design lens.

Consultation and communication between primary and secondary healthcare professionals in a Dutch urbanised area.

37 users of collaboration services (eg, telephone, correspondence) were interviewed between August 2021 and October 2022, including 14 general practitioners (GPs) (10 females, 4 males) and 23 specialists (10 females, 13 males).

Four key domains with subthemes, subdivided per operation and CFIR domain, were identified as central to optimising the collaboration of professionals within the primary-secondary care continuum: (1) software and record integration; (2) seamless personal interaction; (3) eliminating a sense of ‘us vs them’ and (4) gaps in continuity of care.

This study reveals that healthcare professionals in both primary and secondary care face similar collaboration challenges due to system-level issues and inadequate collaboration tools, leading to increased workload, miscommunication and reduced quality of care. Improving collaboration between GPs and specialists requires not only adjustments to individual services, but a comprehensive overhaul of the referral and back-referral process. A more integrated approach, addressing key domains, is crucial for enhancing care quality, streamlining workflows and improving health outcomes.

Gluteal tendon tears—frequently dubbed the ‘rotator cuff tears of the hip’—are a common but often underdiagnosed cause of lateral hip pain and abductor dysfunction, especially in middle-aged to older women. While both open and endoscopic repair techniques are used, current literature suggests similar functional outcomes but higher complication rates following open repair. However, evidence is mainly derived from small retrospective case series, and no randomised trials exist. This systematic review and multilevel meta-analysis aims to compare the efficacy, safety and complication profiles of endoscopic versus open gluteal tendon repair.

A comprehensive literature search will be conducted across PubMed, Embase, CENTRAL and Epistemonikos without language or date restrictions. Eligible studies include randomised controlled trials and observational studies reporting on open or endoscopic gluteal tendon repair. Primary outcomes will include pain, functional scores and complication rates. Risk of bias will be assessed using the RoB 2 tool for RCTs and ROBINS-I for non-randomised studies. A three-level random-effects meta-analysis will be performed using inverse variance weighting and Hartung-Knapp adjustments. Heterogeneity will be quantified using the I² statistic.

Ethical approval is not required for this secondary analysis of published data. Results will be disseminated via peer-reviewed publication and conference presentations.

The review will commence immediately after acceptance of this study protocol in BMJ Open. The systematic review and multilevel meta-analysis will be conducted as efficiently as possible, with anticipated completion approximately 3–6 months after initiation.

CRD420251088765

To construct a data-driven composite from (a subset of) currently used quality indicators for oesophagogastric cancer surgery and to evaluate whether this approach enhances the reliability of between-hospital comparisons on outcome relative to the expert-driven composite indicator ‘textbook outcome (TO)’.

In this retrospective cohort study, we applied Item Response Theory (IRT) to construct a data-driven continuous composite indicator reflecting a single latent variable—the quality of surgical care—and estimated latent variable scores for all individual patients. Reliability was compared between the expert-driven (TO) and data-driven (IRT) composite indicators.

All Dutch hospitals providing oesophagogastric cancer surgery.

All patients who underwent oesophagectomy (n=3588) or gastrectomy (n=1782) between 2018 and 2022 as registered in the Dutch Upper GI Cancer Audit (DUCA).

We evaluated the reliability of between-hospital comparisons using ‘rankability’, which quantifies the proportion of observed variation in indicator scores between hospitals not attributable to chance.

Seven out of 15 quality indicators were included in the IRT composite indicator. Most of the patients were assigned the artificial maximum of the continuous quality score (ie, ceiling effect), resulting in similar average hospital scores. Relative to TO, rankability increased when using the IRT composite for oesophagectomy (57% vs 41%) but declined for gastrectomy (38% vs 47%).

The selected seven quality indicators for oesophageal and gastric cancer surgery represent a single latent variable but are not yet optimal for differentiating surgical care quality due to ceiling effects. Despite using fewer indicators, the continuous IRT score showed a promising increase in rankability for oesophagectomy, suggesting that data-driven composite indicators may enhance hospital benchmarking reliability.

Adolescence is a critical period marked by rapid brain development and the onset of many mental health disorders. Brain MRI studies during adolescence, especially when paired with behavioural phenotypes and information about genetic risk factors, hold promise to advance early identification of mental health risk and spur the creation of targeted treatments to improve patient function, prognosis and quality of life. However, prospective neuroimaging is costly and time-intensive, and individuals who participate may not be reflective of the general population. These challenges are compounded when examining adolescents, as many families lack the time, energy or resources to participate in studies that use research-grade imaging. Repurposing clinical MRIs obviates many of the challenges of neuroimaging research. Here, we describe the brain-behaviour-genetics study protocol. This protocol describes procedures used to recruit participants with recent high-quality clinical brain MRIs and prospectively acquire genetic and sociobehavioural data, resulting in a highly cost-efficient design that harnesses a vast and underused neuroscientific resource.

The brain-behaviour-genetics protocol aims to recruit 1000 adolescents who have clinical brain MRIs contained in Children’s Hospital of Philadelphia’s electronic health record. One or both parents of the adolescent proband will be recruited when possible. Parents and adolescents will complete a series of self-report scales spanning the domains of mental health, trauma, risk and resilience. Saliva samples will be collected from the adolescent and at least one biological parent, using an at-home saliva collection kit. Subsequent analysis will examine associations between brain development, genetics and behavioural measures in adolescence.

Approval for the study had been obtained from the Children’s Hospital of Philadelphia’s institutional review board (IRB #23–0 20 851). Results will be published in peer-reviewed journals.

Patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA) are considered to have a symptomatic venous thromboembolism (VTE) risk of 1.0%–1.5% despite thromboprophylaxis. Fast-track treatment protocols have substantially lowered the VTE risk in most patients. Hence, the majority of patients may be unnecessarily exposed to the burden and risk of thromboprophylaxis. On the contrary, there are still patients with a high VTE risk who develop VTE despite thromboprophylaxis. Thus, tailored thromboprophylaxis treatment may potentially reduce both VTE and bleeding risk.

The DISTINCT (inDividual, targeted thrombosIS prophylaxis versus the standard ‘one-size-fits-all’ approach in patients undergoing Total hIp or total kNee replaCemenT) trial is a national, multicentre, randomised, multiarm, open-label trial. The main objective is to study whether tailored thromboprophylaxis reduces the occurrence of symptomatic VTE (primary outcome) and major bleeding (primary safety outcome) within 90 days after THA/TKA in comparison with standard thromboprophylaxis. Patients with a low, intermediate or high predicted VTE risk (based on the Thrombosis Risk Prediction following total hip and knee arthroplasty score (TRiP(plasty) score)) will be included in the DISTINCT-1, DISTINCT-2 or DISTINCT-3 studies, respectively. In the DISTINCT-1 trial, 3478 patients will be randomly allocated to receive either in-hospital thromboprophylaxis or standard prophylaxis. In the DISTINCT-2 cohort study, 2500 patients will receive standard prophylaxis. In the DISTINCT-3 trial, 4100 patients will be randomly allocated to receive either 6 weeks of high-dose thromboprophylaxis or standard prophylaxis. Standard prophylaxis consists of a low dose of any approved thromboprophylactic agent for 4 weeks. We hypothesise that (1) the efficacy of in-hospital only thromboprophylaxis is non-inferior in preventing VTE and equally safe compared with standard prophylaxis in patients with a low VTE risk (DISTINCT-1) and (2) prolonged high-dose thromboprophylaxis is superior in preventing VTE as compared with standard prophylaxis in patients with a high VTE risk (DISTINCT-3). Patients with intermediate VTE risk will be observed to evaluate VTE and bleeding rates (DISTINCT-2).

The protocol has been approved by the Medical Research Ethics Committee Leiden-Den Haag-Delft, EU-trial-number 2023-510186-98. Study results will be disseminated through peer-reviewed journals and during international conferences.

NCT06581965.

Patient engagement (PE), or a patient’s participation in their healthcare, is an important component of comprehensive healthcare delivery, yet there is not an existing, publicly available, measurement tool to assess PE capacity and behaviours. We sought to develop a survey to measure PE capacity and behaviours for use in ambulatory healthcare clinics.

Measure development and psychometric evaluation.

A total of 1180 adults in the USA from 2022 to 2024, including 1050 individuals who had indicated they had seen a healthcare provider in the prior 12 months who were recruited nationally via social media across three separate samples; 8 patient advisors and healthcare providers recruited from a large, midwestern US Academic Medical Center; and 122 patients recruited from five participating ambulatory clinics in the Midwestern USA.

An initial survey was developed based on a concept mapping approach with a Project Advisory Board composed of patients, researchers and clinicians. Social media was then used to recruit 540 participants nationally (Sample 1) to complete the initial, 101-item version of the survey to generate data for factor analysis. We conducted exploratory and confirmatory factor analyses to assess model and item fit to inform item reduction, and subsequently conducted cognitive interviews with eight additional participants (patient advisors and providers; Sample 2), who read survey items aloud, shared their thoughts and selected a response. The survey was revised and shortened based on these results. Next, a test–retest survey, also administered nationally via another round of social media recruitment, was administered two times to a separate sample (n=155; Sample 3), 2 weeks apart. We further revised the survey to remove items with low temporal stability based on these results. For clinic administration, research staff approached patients (n=122; Sample 4) in waiting rooms in one of five ambulatory clinics to complete the survey electronically or on paper to determine feasibility of in-clinic survey completion. We engaged in further item reduction based on provider feedback about survey length and fielded a final revised and shortened survey nationally via a final round of social media recruitment (n=355; Sample 5) to obtain psychometric data on this final version.

Cronbach’s alphas, intraclass correlations (ICCs), Comparative Fit Index (CFI), root mean square error of approximation (RMSEA), standardised root mean squared residual (SRMR).

The final PE Capacity Survey (PECS) includes six domains across two scales: ‘engagement behaviours’ (ie, preparing for appointments, ensuring understanding, adhering to care) and ‘engagement capacity’ (ie, healthcare navigation resources, resilience, relationship with provider). The PECS is 18 questions, can be completed during a clinic visit in less than 10 minutes, and produces scores which demonstrate acceptable internal consistency reliability (α=0.72 engagement behaviours, 0.76 engagement capacity), indicating items are measuring the same overarching construct. The scales also had high test–retest reliability (ICC=0.82 behaviours, 0.86 capacity), indicating stability of response over time, and expected dimensionality with high fit indices for the final scales (behaviours: CFI=0.97; RMSEA=0.07; SRMR=0.05; capacity: CFI=0.99; RMSEA=0.06; SRMR=0.06), indicating initial evidence of construct validity.

The PECS is the first known measure to assess patients’ capacity for engagement and represents a step toward informing interventions and care plans that acknowledge a patient’s engagement capacity and supporting engagement behaviours. Future work should be done to validate the measure in other languages and patient populations, and to assess criterion-related validity of the measure against patient outcomes.

‘Hotspotters’ are patients with complex care needs, defined by problems in multiple life domains and high acute care use. These patients often receive mismatched care, resulting in overuse of care and increased healthcare costs. As reliable data on effective interventions for this population are scarce, the goal of this study is to assess the cost-effectiveness of proactive, personalised, integrated care for this group.

The Hotspotters Project is planned as a stepped wedge cluster randomised controlled trial in 20 primary care practices in the Netherlands. All practices and participants will begin with standard care during the control period (2–8 months), followed by an intervention (12 months) consisting of a positive health intake with goal setting, multidisciplinary meetings, a personalised care plan and proactive care management. The study will conclude with a follow-up (2–8 months), resulting in a total study duration of 22 months. We plan to include 200 patients with (a) problems on two or more life domains and (b) at least two acute care encounters in the previous year. Possible Hotspotters are identified using an Adjusted Clinical Groups-based algorithm or via a local primary healthcare team.

Questionnaires and routine care data will be used to gather data on cost-effectiveness, which will then be assessed using multilevel analysis, with levels for the individual, cluster and duration of control period. Secondary outcomes will include psychological outcomes on self-regulation (proactive coping, patient activation, self-efficacy and intention), experience of care (satisfaction, perceived autonomy support and qualitative data from focus groups) and quality of life, qualitative analysis of the Positive Health approach, implementation outcomes and process evaluation including integration of care.

The Ethics Committee of Leiden University Medical Centre granted approval (METC-LDD, P21.123). Results will be shared through peer-reviewed publication and (inter)national conference presentations.

NCT05878054.

High-grade squamous intraepithelial lesions are caused by persistent high-risk human papillomavirus (hr-HPV) infections and are subdivided into cervical intraepithelial neoplasia (CIN) lesions: CIN II (moderate) and CIN III (severe). Current treatment options for CIN II include large loop excision of the transformation zone, imiquimod and expectant management. Each treatment option has its drawbacks, and therefore, a non-invasive treatment is desirable. Preliminary evidence shows that medical-grade honey (MGH) has antiviral activity and might be able to modulate the vaginal microbiome, reduce local inflammation or directly influence the intralesional immune response within cervical tissues. Therefore, this study aims to investigate the possible effect of MGH on hr-HPV clearance and to investigate the possible underlying mechanisms contributing to the regression of CIN II lesions.

This study is performed in the Zuyderland Medical Centre and Maastricht University Medical Centre+. A total of 60 eligible women with newly histologically confirmed CIN II will receive MGH (L-Mesitran Soft) for intravaginal use for 6 months. The primary objective is to investigate the effect of MGH on the hr-HPV clearance after 6 months. Secondary aims are the effect of MGH on the regression of CIN II lesions, clearance of hr-HPV at 12 and 24 months and the role of the vaginal microbiome, local immune system and intravaginal inflammatory status in response to MGH. Moreover, data on quality of life, side effects and compliance will be collected.

Ethical approval from the Medical Ethics Review Committee of the Zuyderland Medical Centre Heerlen has been obtained (NL86044.096.24 on 24 April 2024). The results will be presented to researchers and healthcare professionals through conferences, meetings and publications in international journals.

NCT06219018.

Admission to a surgical intensive care unit (ICU) following major surgery is associated with a number of discomforts, not only related to the disease itself but also to the care provided or the ICU environment itself (lights, sounds, pain, sleep deprivation, thirst, etc). This discomfort is real and can be associated with psychological consequences. We hypothesised that the use of immersive virtual reality (IVR) with HypnoVR is feasible and can help reduce discomfort in intensive care.

The ZION trial is a prospective, monocentric trial randomising 194 patients admitted to a surgical ICU after a major surgery. The inclusion criterion is patients admitted to a surgical ICU for at least 48 hours following major surgery (cardiac, thoracic or major abdominal surgery). Patients will be allocated to the intervention group (n=97) or the control group (n=97). In the intervention group, patients will receive IVR using HypnoVR two times a day during the ICU stay (2–5 days). In the control group, postoperative care will be conducted according to standard care without IVR. The primary endpoint will be the 18-item IPREA (Inconforts des Patients de REAnimation) questionnaire on the day of ICU discharge. The secondary endpoints will include intensity of discomfort symptoms (anxiety, pain, dyspnoea, thirst and sleep deprivation); the 18-Item IPREA Questionnaire assessed daily from randomisation to the V1 follow-up visit (ICU discharge); incidence of delirium; cumulative morphine consumption at ICU discharge; length of ICU stay and anxiety or depression at 1 month after discharge from intensive care and patient experience of device use.

Ethical approval was obtained from the institutional review board of the University Hospital of Amiens (Registration number ID: 2024-A01528-39) in January 2025.

NCT06830369.