This study analysed the clinical outcomes and healthcare costs associated with diabetic foot ulcer (DFU) within a tertiary healthcare centre in Singapore.
This is a retrospective, single-centre study. Patient data were extracted from the hospital’s electronic health system, including demographic, clinical and hospitalisation information. Hospitalisation costs were categorised into DFU-related and other hospitalisation costs. A one-way sensitivity analysis was performed to estimate the total healthcare costs associated with DFU.
Tertiary centre within a population suffering from a diabetic epidemic.
All patients aged 18 years or older who received DFU treatment between January 2019 and December 2023 at the Singapore General Hospital were included.
A total of 2857 DFU patients were included in the study. In-hospital mortality remained stable at 5%–6% annually. Among the cohort, 39.1% underwent minor amputations, 19.6% had major amputations and 9.0% experienced both minor and major amputations. The median length of stay for surgical patients ranged from 10 (IQR 4–24) to 13 days (IQR 6–31), compared with 4 (IQR 2–8) to 5 (IQR 3–9.5) days for non-surgical patients. Total costs per admission for patients with DFU-related surgery ranged from US$28 588.96 to US$34 204.77, while for those without surgery, costs ranged from US$6637.59 to US$7955.23. Total hospitalisation costs for DFU during the study period ranged from US$65.87 million to US$72.16 million. All figures were inflation adjusted to 2023 US dollars.
DFU poses a significant clinical and economic burden in Singapore. Understanding the costs associated with DFU is essential for resource allocation and planning in DFU management.
To provide a contemporary, postpandemic description of UK occupational therapy and physiotherapy practice to rehabilitate the upper limb after stroke.
A national online survey, first undertaken in 2018 (prepandemic), was readministered to describe postpandemic practice.
The survey was distributed to UK-based occupational therapists and physiotherapists working with people after stroke, via professional and social networks.
Shaped by the Template for Intervention Description and Replication Checklist, the survey collected and subsequently analysed the content, frequency and duration of upper limb rehabilitation after stroke.
A total of 122 occupational therapists (n=42) and physiotherapists (n=80) currently working clinically, across in-patient, out-patient and community settings, in the UK completed the survey. Respondents reported treating the upper limb a median of three times a week (IQR 2–4; range 0–6) for a median of 25 min (IQR: 20–35; range 3–60; n=119). Repetitive, functionally-based activities were the most commonly reported interventions for mild (n=93; 81%) and moderate (n=72; 64%) impairment. Stretching (n=73; 66%) and positioning (n=49; 45%) were most frequently reported for severe impairment. In each of the three impairment categories, a larger number of interventions were reported than in the 2018 survey.
While the pandemic promoted the use of virtual interventions, most therapists had returned to face-to-face interventions. The findings highlight that the current reported provision of upper limb therapy continues to be markedly less than the dose shown to be effective. The study provides important data which can be used to judge the success of attempts to align practice with new guidelines and inform ‘usual therapy’ for the upper limb after stroke in comparative studies.
To investigate discrepancies in perceptions regarding the accessibility and availability of rest and relaxation (R&R) spaces between hospital doctors in Scotland and NHS Scotland regional health boards (HBs), with the intention of informing best practices for organisational policy on the provision of R&R spaces both now and in the future.
A qualitative study, through an inhabited institutionalism (II) lens, of semi-structured interviews of hospital doctors across the career continuum in Scotland and all NHS regional HBs in Scotland providing written information relating to R&R space provision.
NHS Scotland during the COVID-19 pandemic and beyond.
Hospital doctors (n=30) who had participated in a larger qualitative study and provided specific insights on R&R spaces. All NHS Scotland regional HBs (n=14).
Although HBs reported the provision of R&R spaces, numerous doctors reported R&R spaces had been removed, relocated or were inaccessible. Furthermore, limited awareness of their availability attributed to inadequate communication, compounded the issue. This divergence between institutional reporting and front-line experience can be interpreted through the lens of II, which posits that institutional polices are often interpreted and implemented differently.
This study emphasises how crucial R&R spaces are to promoting doctors’ well-being especially during the time of high stress. HBs must not only guarantee the accessibility and physical availability of R&R spaces but also enhance their communication regarding the provision.
‘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.
Breast cancer risk can be substantially reduced with risk-reducing medications (RRMeds). Despite their efficacy, and guidelines which support their use for women at substantially increased risk of breast cancer, they are underused. Barriers to their use in Australia include a lack of awareness of RRMeds by women and clinicians, and a primary care workforce that reports a lack of knowledge and confidence in discussing and/or prescribing these medications. In contrast, Australian clinicians have reported specialist support and guidance as a key facilitator. The Preventing Cancer with Medications (PCMed) Telehealth Service was therefore developed to provide this specialist support and to bridge the evidence–implementation gap. The PCMed Service endeavours to increase the appropriate use of RRMeds and support women and their doctors throughout treatment. The aim of this research is to evaluate the effectiveness, adoption, acceptability, feasibility, fidelity and cost of this new Service, and to determine any adaptations that might be required.
The research uses a mixed methods approach. Effectiveness of the PCMed Service will be evaluated by determining whether the PCMed Service is associated with increased uptake of RRMeds compared with historical data. Secondary outcomes include: adoption of the Service, specifically, the proportion of women who attend a PCMed Service consultation; acceptability of the Service for clients and referring clinicians (using a brief survey and semistructured interviews); feasibility and fidelity by evaluating the adherence to the planned Service processes; and the cost, by reporting the difference between funding received per woman and the cost for service delivery.
This study was approved by the institutional Human Research Ethics Committee (EC00235): HREC/101142/PMCC. The findings will inform future iterations of the Service prior to scaling up. Research findings will be disseminated at scientific meetings and in peer-reviewed journals.
Globally, the demand for community palliative care, delivered within the home setting, is rising. Hospice support workers, also referred to as healthcare assistants, play a crucial role in providing this care, but evidence indicates they face challenges relating to inadequate training, isolation and emotional labour. This realist review aims to understand how peer support interventions can support healthcare assistants in delivering hospice care at home.
The realist review will follow a five-step process to explore the research question: (1) locating existing initial programme theories, (2) searching for evidence, (3) selecting and appraising evidence, (4) extracting and organising data and (5) synthesising evidence and drawing conclusions. Comprehensive searches of academic databases (CINAHL, MEDLINE, AMED, Scopus) and grey literature sources will be conducted between November and December 2024, with no restrictions on publication date applied. Search strategies will be iteratively refined, with evidence selected based on relevance and rigour. Data will be extracted and coded using a realist logic model of analysis. The review will develop an explanatory programme theory for peer-to-peer interventions which would identify what, how, for whom, why and in what circumstances peer-to-peer interventions may support delivery of hospice care at home. It will explore the contexts, mechanisms and outcomes of these interventions using context-mechanism-outcome configurations.
Ethical approval is not required as the review involves no primary data collection. This review aims to clarify research gaps, inform next stages of a wider study, policy and practice. Reporting of the findings will adhere to RAMESES publication standards for realist syntheses, ensuring transparency and rigour in reporting. Results will be disseminated through peer-reviewed publications, conference presentations and other strategies identified by the stakeholder group.
CRD42024606133.
Despite parents’ efforts, many children have nutrient-poor diets with insufficient fruit and vegetable consumption. Parents significantly influence children’s eating habits at home through their food parenting practices. Although previous systematic reviews have explored food parenting practices, they were conducted some time ago. Therefore, it is timely to investigate the relationship between autonomy-supportive practices and fruit/vegetable consumption in children aged 2 to 12.
The systematic review and meta-analysis protocol will be conducted by Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. The databases PubMed, Scopus, Web of Science, PsycINFO, EMBASE, LILACS and Google Scholar will be searched with no restrictions on publication year, country or language. In addition to the databases, the search will be supplemented by manual searches of reference lists from the included articles. Studies that assess at least one parental autonomy-supportive food practice and its relationship with fruit and vegetable consumption in healthy children aged 2 to 12 years will be included. Results will be organised in tables and figures. A meta-analysis will be conducted if data availability permits. Risk of bias will be assessed using Joanna Briggs Institute tools. All steps will be conducted independently by two reviewers.
Findings from this review will be important for understanding the influence of parental autonomy-supportive food practices on children’s fruit and vegetable consumption, potentially informing health practices that promote healthy eating habits from childhood. No ethical approval is required for this review, and we plan to publish the findings in a peer-reviewed journal.
CRD42023442680.
Multiple chemical sensitivity (MCS) describes reported adverse reactions to exposure to common chemical agents (solvents, odourants, air pollutants, material or substances) in low doses tolerated by most people. Symptoms involve more than one organ system and responses are triggered by multiple, chemically unrelated substances.
The systematic review will aim to answer six questions: Which definitions of MCS have been validated? What is the diagnostic performance of tools for identifying MCS? What is the prevalence and incidence of MCS? What is the empirical evidence that MCS is a distinct disorder? What is the empirical evidence for underlying biological mechanisms for MCS? What are the effectiveness and safety of treatment and management strategies for MCS?
We will conduct a comprehensive search in 22 multidisciplinary databases for primary and secondary research, research registries and clinical practice guideline repositories. We will reference-mine reviews and included studies, and confer with experts. Screening will be conducted in duplicate against prespecified eligibility criteria. Data abstraction will be pilot tested using detailed data abstraction forms to ensure accuracy and minimise ambiguity. Critical appraisal will be specific to the key question. We will synthesise data in comprehensive tables and figures. Where possible, meta-analysis will use random effects models to determine effect sizes.
This study was determined to be exempt from review (UP-22-00516). The results will be disseminated through a journal manuscript, and the data will be publicly accessible through an online data repository.
CRD420250645577.
Patients with chronic limb-threatening ischaemia (CLTI) are often prescribed clopidogrel in order to reduce their risk of major adverse limb and cardiovascular events. Clopidogrel is metabolised by the CYP2C19 enzyme and genetic variations in CYP2C19 are common. These variants can influence an individual’s ability to metabolise clopidogrel to its active metabolite. Few studies have investigated the relationship between patient genotype and outcomes in vascular surgery. This work aims to establish the relationship between patient genotype and outcomes after revascularisation in patients with CLTI who are prescribed clopidogrel. It will consider whether pharmacogenetics can be used to ensure patients are prescribed effective medications to optimise their outcomes.
This is an observational cohort study of patients undergoing lower limb surgical, endovascular or hybrid revascularisation for CLTI at Manchester University NHS Foundation Trust. Patients taking clopidogrel post-procedure, as well as those prescribed a non-clopidogrel based medication regimen, will be recruited prior to or shortly after revascularisation. Patients will undergo CYP2C19 genotyping and will be followed up using online records. The study has 90% power to detect 114 amputations with a target sample size of 483 participants. The primary outcomes are risk of amputation at 1 year and a composite endpoint for the risk of major adverse limb events (MALE) or death from any cause at 1 year. Secondary outcomes are risk of MALE at 1 year, risk of major adverse cardiovascular events (MACE) or death from any cause at 1 year, death within 30 days of revascularisation, minor re-interventions at 1 year, total number of re-interventions at 1 year and rate of systemic or gastrointestinal bleed at 1 year.
Risk of amputation, MALE and MACE will be analysed using Cox models. All remaining outcomes will be analysed using negative binomial models. Potential competing events for the risk of amputation will be investigated as part of a sensitivity analysis. Patients given a non-clopidogrel-based medication will be compared as an additional analysis.
Manchester University Research Ethics Committee approval obtained as part of the Implementing Pharmacogenetics to Improve Prescribing (IPTIP) trial process (IRAS 305751). The results of the study will be published in a peer-reviewed journal and presented at international conferences.
This work is a sub-protocol for the IPTIP study which is registered as ISRCTN14050335.
Herpes simplex virus 1 (HSV-1) infects approximately two-thirds of the global population under the age of 50 years. Although widely prevalent, the possible implications of HSV-1 in neurodegenerative diseases, especially dementia and Alzheimer’s disease, remain poorly understood. This review seeks to elucidate this association and explore the potential benefits of preventing or treating herpesvirus infections on dementia risk. The goal is to enhance our understanding of HSV-1’s potential role in dementia, which could inform the development of future therapeutic interventions for these conditions.
PubMed, Embase (Elsevier/Ovid), Web of Science, Scopus, Global Health, PsycInfo, Cochrane Library and Clinicaltrials.gov will be searched from the inception of each respective database. Studies that have HSV-1 as an exposure and dementia, or its subtypes, as a primary outcome will be included. Two researchers will independently screen titles, abstracts and full texts, with discrepancies resolved by a third researcher. Systematic data extraction from eligible studies will be performed using a standardised template. Risk of bias of individual studies will be assessed with the Cochrane Collaboration approach. We will assess the overall quality of cumulative evidence using the Grading of Recommendations, Assessment, Development and Evaluations criteria. Statistical analysis will employ a random effects model, and heterogeneity will be determined with Cochrane’s Q test and assessed using I2. Studies will be grouped by population subgroups and dementia subtypes when possible to explore nuances in results. We will consider performing meta-regression if heterogeneity remains after subgroup analyses. All statistical analyses will be conducted using Stata V.18 software (College Station, Texas, USA).
No ethical approval is required since data will be collected from existing studies. The review will be disseminated through peer-reviewed publication and at national and international conferences.
CRD42024516789.
To evaluate if 10 sessions of hyperbaric oxygen treatments (HBOTs) improve short- and long-term health related quality of life, symptoms and physical performance in long covid patients compared with placebo.
Parallel, randomised, placebo-controlled, double-blind trial.
Single-centre, university hospital, Sweden.
Previously healthy subjects aged 18–60 years, diagnosed with long covid were included. We excluded pregnant women, patients with RAND-36 (role limitations due to physical health (RP) and physical functioning (PF)) above 70, diabetes, hypertension and contraindications for HBOT.
Subjects were randomly assigned to 10 sessions of HBOT or sham (placebo) treatments over 6 weeks. HBOT involved 100% oxygen, 2.4 bar, 90 min, placebo medical air, 1.34–1.2 bar. Randomisation (1:1) was done electronically, in blocks stratified by sex and disease severity. Subjects and investigators were blinded to allocation.
Primary endpoints were changes from baseline in RAND-36 PF and RP at 13 weeks. Efficacy was analysed on an intention-to-treat basis. Harms were evaluated according to the actual treatment given.
Between 15 September 2021 and 20 June 2023, 80 subjects (65 women, 15 men) were enrolled and randomised (40 in each group). The trial is completed. The primary endpoint analysis included 79 subjects (40 in HBOT and 39 in control). At 13 weeks, both groups showed improvement, with no significant difference between HBOT and placebo in PF (least square mean difference between groups (LSD), 0.63 (95% CI –7.04 to 8.29), p=0.87) and RP (LSD, 2.35 (95% CI –5.95 to 10.66), p=0.57). Harms: 43 adverse events (AEs), most commonly cough and chest pain/discomfort, occurred in 19 subjects (49%) of the HBOT group and 38 AEs in 18 subjects (44%) of the placebo group, one serious AE in HBOT and one death in the placebo group.
10 HBOT sessions did not show more short-term benefits than placebo for long covid patients. Both groups improved, with a notable sex difference. HBOT has a favourable harm profile.
ClinicalTrials.gov (NCT04842448), EudraCT (2021-000764-30). The trial was funded by Vetenskapsrådet (2022-00834), Region Stockholm (2020-0731, 2022-0674), Hjärt-Lungfonden and OuraHealth Oy.