Diabetes affects ~10% of the world’s population and is rising. Treatment costs in the UK are ~15% of the NHS budget. Diabetes-related complications can be lowered through better evidence-based clinician management and patient self-management. MyWay intelligence quotient (MWIQ) is an electronic platform that will provide clinical decision support around the diagnosis and treatment of patients with diabetes. This study evaluates the safety and clinical performance (clinical appropriateness/applicability, clinical impact and clinical usability) of MWIQ.
The system will be implemented in real time in four to seven general practitioner (GP) practices. Clinicians with diabetes expertise will be recruited as validators, who will inspect records to ensure system robustness before use, and up to 14 healthcare professionals will use and evaluate the system.
Quantitative and qualitative analyses will be triangulated to assess the MWIQ system. Assessment of clinical outcomes will be made using pseudonymised routinely collected clinical data, including adherence to quality performance indicators, diabetes diagnosis, diabetes investigations (eg, genetic testing), HbA1c, blood pressure, body mass index, cholesterol and foot risk score for the diabetes population concerned. Clinical and validator participants will also submit a weekly questionnaire, and these, along with interviews, which are scheduled during the testing process, will be analysed to provide data on the utility, safety and usability of the system.
This study was approved, 08/01/2024, by the North of Scotland Research Ethics Committee (REC), IRAS project ID: 305267, REC, reference 23/NS/0134. The study has gained confidentiality advisory group (CAG) support (reference: 24/CAG/0002), medicines and healthcare products regulatory agency (MHRA) and health research authority (27/08/2024) approvals.
Findings will be reported to (1) The funding body, (2) The participating GP practices, (3) The study PPIE group, (4) The MHRA to support a submission for recognition as a class 2 CE/UKCA marked device, (5) Presented at local, national and international conferences and (6) Disseminated by peer-reviewed publications.
Squamous cell carcinoma and multiple actinic keratoses caused by solar ultraviolet radiation (UVR) are among the most frequently recognised occupational diseases in Germany. Employees who regularly work outdoors, for example, in the construction industry, agriculture, forestry and gardening, are at a higher risk of developing occupational skin cancer. However, sun-safety behaviour in outdoor workers is currently insufficient. Therefore, this study aims to investigate the effectiveness of an intervention to increase sunscreen use among outdoor workers.
In this non-randomised, controlled intervention study, 234 outdoor workers from different companies in industries with outdoor working activities based in Germany will be included. The study population, aged 18 years and above, has to be intensively exposed to solar UVR of regularly 1 hour or more per day. The intervention group will receive a sunscreen package as well as health education. The control group follows the practice in their companies (‘treatment-as-usual’). At the beginning of the study, after 3 months and at the end of the study (after 6 months), both groups filled in different questionnaires. In addition, stratum corneum (SC) samples will be collected at the beginning and after 3 months. The primary outcome—increase in the frequency of sunscreen use during work and in leisure time—will be assessed from data on self-reported sunscreen use. The secondary outcomes include sun protection behaviour, knowledge about sun protection and skin cancer, and acceptance of the provided sunscreens. Further secondary outcomes include internal UV dose and UV-related immune response, determined by the levels of SC biomarkers. Data will be analysed using both descriptive and inferential methods.
The study protocol followed the principles of the Declaration of Helsinki (2013) and was approved by the Ethics Committee of Osnabrück University, Germany (reference Ethik-37/2024). Study results will be disseminated through peer-reviewed publications and conference presentations.
DRKS00035178.
Current guideline-recommended antibiotic treatment durations for ventilator-associated pneumonia (VAP) are largely standardised, with limited consideration of individual patient characteristics, pathogens or clinical context. This one-size-fits-all approach risks both overtreatment—promoting antimicrobial resistance and adverse drug events—as well as undertreatment, increasing the likelihood of pneumonia recurrence and sepsis-related complications. There is a critical need for VAP-specific biomarkers to enable individualised treatment strategies. The Ventilator-associated pneumonia Biomarker Evaluation (VIBE) study aims to identify a dynamic alveolar biomarker signature associated with treatment response, with the goal of informing personalised antibiotic duration in future clinical trials.
VIBE is a prospective, observational, case-cohort study of 125 adult patients with VAP in Michigan Medicine University Hospital intensive care units. Study subjects will undergo non-bronchoscopic bronchoalveolar lavage on the day of VAP diagnosis (Day 1) and then on Days 3 and 5. Alveolar biomarkers (quantitative respiratory culture bioburden, alveolar neutrophil percentage and pathogen genomic load assessed via BioFire FilmArray polymerase chain reaction) will be assessed. An expert panel of intensivists, blinded to biomarker data, will adjudicate each patient’s Day 10 outcome as VAP clinical cure (control) or treatment failure (case). Absolute biomarker levels and mean-fold changes in biomarker levels will be compared between groups. Data will be used to derive a composite temporal alveolar biomarker signature predictive of VAP treatment failure.
Ethical approval was obtained from the University of Michigan Institutional Review Board (IRB #HUM00251780). Informed consent will be obtained from all study participants or their legally authorised representatives. Findings will be disseminated through peer-reviewed publications, conferences and feedback into clinical guidelines committees.
To assess the feasibility of conducting a definitive randomised controlled trial (RCT) to test the clinical and cost-effectiveness of a tailored exercise intervention compared with usual care for people aged 80 years and older with hip and/or knee osteoarthritis (OA) and comorbidities.
Two-arm, parallel-design, multicentre, pragmatic, feasibility RCT.
Four National Health Service outpatient physiotherapy services across England.
Adults aged 80 years and over with clinical hip and/or knee OA and ≥1 comorbidity.
Participants were randomised 1:1 via a central web-based system to be offered: (1) a 12-week tailored exercise programme or (2) usual care. Participants and outcome assessors were not blinded to treatment allocation.
(1) Ability to screen and recruit participants; (2) retention of participants at 14-week follow-up; (3) intervention fidelity (proportion of participants who received ≥4 intervention sessions as per protocol) and (4) participant engagement (assessed by home exercise adherence).
Between 12 May 2022 and 26 January 2023, 133 potential participants were screened, of whom 94 were eligible. The main reasons for ineligibility were symptoms not consistent with hip or knee OA (10/39, 25.6%) or already having had a physiotherapy appointment (8/39, 20.5%). 51 of 94 (54%) eligible participants were recruited. Participants had a mean age of 84 years (SD 3.5), 31 (60.8%) were female and 96.1% reported their ethnicity as White British (n=49/51). 45 of 51 participants (88%) provided outcome data at the 14-week follow-up time point. Four or more intervention sessions were attended by 13/25 (52%) participants. Home exercise log completion declined over time: 6/23 participants (26.1%) returned completed exercise logs for all 12 weeks. The median number of days home exercises were recorded each week was 5 (range 0–7).
This study demonstrated that a definitive trial would be feasible. Before proceeding, modifications to ensure recruitment of a diverse population and intervention fidelity should be addressed.
by Connie Nait, Simple Ouma, Saadick Mugerwa Ssentongo, Boniface Oryokot, Abraham Ignatius Oluka, Raymond Kusiima, Victoria Nankabirwa, John Bosco Isunju
BackgroundDespite advances in HIV care, viral load suppression (VLS) among adolescents living with HIV (ALHIV) in Uganda continue to lag behind that of adults, even with the introduction of dolutegravir (DTG)-based regimens, the Youth and Adolescent Peer Supporter (YAPS) model, and community-based approaches. Understanding factors associated with HIV viral load non-suppression in this population is critical to inform HIV treatment policy. This study assessed the prevalence and predictors of viral load non-suppression among ALHIV aged 10–19 years on DTG-based ART in Soroti City, Uganda.
MethodsWe conducted a cross-sectional study among 447 ALHIV attending three urban HIV clinics in Soroti City. Data were abstracted using a structured questionnaire and analyzed in STATA 15.0. Modified Poisson regression with robust error variance was used to identify predictors of viral load non-suppression. Adjusted relative risks (aRR) and 95% confidence intervals (CIs) were reported, with statistical significance set at p ≤ 0.05.
ResultsOf the 447 participants, 53.5% were female, with a median age of 16 years (IQR: 14.0–17.6). The majority (72.9%) were from Soroti district and had been on DTG-based ART for a median of 42.5 months (IQR: 37.0–48.0). Most were receiving multi-month dispensing (MMD) (75.2%) and were active in care (98%). The prevalence of viral load non-suppression was 19.2% (86/447). Independent predictors of non-suppression included older age (15–19 vs. 10–14 years) (aRR: 1.69; 95% CI: 1.08–2.67), male sex (aRR: 1.48; 95% CI: 1.05–2.11), prior non-suppression before switching to DTG (aRR: 1.76; 95% CI: 1.19–2.59), use of non-fixed dose DTG regimens (aRR: 2.03; 95% CI: 1.23–3.33), history of poor adherence (aRR: 4.36; 95% CI: 2.05–9.26), and not receiving MMD (aRR: 2.83; 95% CI: 1.93–4.15).
ConclusionNearly one in five adolescents on DTG-based ART in Soroti City had viral non-suppression, despite optimized treatment regimens. Targeted interventions−particularly enhanced adherence counseling for older and male adolescents, expanding MMD coverage, and provision of fixed-dose regimens−are urgently needed to improve VLS among ALHIV. These findings underscore the need for adolescent-centered HIV care strategies to close the viral suppression gap and advance progress towards epidemic control.
Dynamic and complex health systems require innovative and adaptive solutions to support patient safety and achieve equitable health outcomes for Indigenous populations. Understanding the ways by which Indigenous (and specifically Māori) nurse practitioners (NPs) practice patient safety is key to enhancing Indigenous health outcomes in predominantly westernized healthcare systems.
To describe Māori NPs perspectives on patient safety when caring for Māori and understand how Māori NPs deliver safe health care.
A group of five Māori NPs worked alongside a Māori nurse researcher to explore their perceptions of patient safety. Together, they held an online hui (focus group) in early 2024. Data were analysed collectively, informed by kaupapa Māori principles, using reflexive thematic analysis.
Māori NP experiences, expressions and understandings of patient safety envelop cultural safety and have many facets that are specific to the needs of Māori populations. The three themes showed: (1) Te hanga a te mahi: the intersection of cultural and clinical expertise; (2) Mātauranga tuku iho: the knowledge from within, where safe practice was strongly informed by traditional knowledge and cultural practice; (3) Te Ao hurihuri: walking in two worlds, where Māori NPs navigated the westernized health system's policies and practices while acting autonomously to advocate for and deliver culturally safe care.
The Māori NP lens on patient safety is vital for promoting culturally responsive and effective health care. By recognizing the unique needs of Māori patients and families and incorporating cultural perspectives into practice, Māori NPs contribute to a more comprehensive and inclusive approach to patient safety that goes beyond westernized principles and practices.
No patient or public contribution.
by Grant L. Austin, Feng Wang, Steven Q. Le, Alexander Sorensen, Shan Li, Lai C. Foong, Srikanth Singamsetty, Jill Wood, Tsui-Fen Chou, Patricia I. Dickson
Mucopolysaccharidosis type IIID (MPS IIID; Sanfilippo D) is caused by biallelic pathogenic variants in N-acetylglucosamine-6-sulfatase (GNS), which participates in catabolism of heparan sulfate (HS) glycosaminoglycans. Characterization of MPS IIID disease at a cellular level has not been robustly achieved. We used unbiased quantitative proteomics to establish a cellular phenotype for MPS IIID mice. Recombinant human GNS (rhGNS), a variant of which previously demonstrated single dose efficacy in MPS IIID human fibroblasts and in MPS IIID neonatal mice, was used to establish a repeat dosing schedule to treat MPS IIID mice. Adult Gns KO mice or heterozygous carriers were treated via intracerebroventricular (ICV) injections and received 3, 30, or 200 μg rhGNS in 4 doses over 2 weeks or vehicle. Twenty-four hours after the final dose, HS in brain and CSF showed dose-dependent reductions, reaching carrier levels in the higher dose groups. Furthermore, the proteomic perturbations that we described were corrected by rhGNS treatment. Next, Gns KO or carrier adult mice were treated via ICV and received 3, 30 or 200 μg rhGNS or vehicle once every two weeks (Day 1, 15, 29, 43, 57, 71, 85) and were euthanized on day 91. Following treatment, total HS and MPS IIID-specific HS (GlcNAc6S) showed dose-dependent reductions in brain and CSF and markers of neuroinflammation were substantially reduced. ICV enzyme replacement therapy with rhGNS restores CNS pathology of adult MPS IIID mice even with treatment at 14-day intervals, demonstrating preclinical efficacy for MPS IIID.Commentary on: Jabbie L, Walshe C, Ahmed F (2023). The views and perceptions of training in physical health care amongst mental health nurses, managers of mental health nurses and trainers: A systematically constructed narrative synthesis. International Journal of Mental Health Nursing. DOI: 10.1111/inm.13253.
The authors of this narrative review conclude that mental health nurses’ preparation for delivering physical healthcare interventions is suboptimal and requires regular supplementation. There is a need to establish what level of proficiency in physical healthcare skills mental health nurses require.
People with severe mental illness, notably those with psychosis, live 10 years less than the general population. Most premature death is from natural causes, chiefly cardiovascular disease and cancer.
by Anna Novotna, Klara Horackova, Jana Soukupova, Petra Zemankova, Petr Nehasil, Pavel Just, Ludek Voska, Petra Kleiblova, Silvie Rajnochova Bloudickova
IntroductionRenal cell carcinoma (RCC) is one of the most prevalent cancers in kidney transplant recipients (KTR). The hereditary background of RCC in native kidneys has been determined, implicating its clinical importance.
Materials and methodsThis retrospective single-center pilot study aimed to identify a potential genetic predisposition to RCC of the transplanted kidney and outcome in KTR who underwent single kidney transplantation between January 2000 and December 2020 and manifested RCC of the transplanted kidney. Next-generation sequencing (NGS) based germline genetic analysis from peripheral blood-derived genomic DNA (gDNA) was performed in both the recipient and donor using a gene panel targeting 226 cancer predisposition genes.
ResultsThe calculated incidence of RCC of the transplanted kidney among 4146 KTR was 0.43%. In fifteen KTR and donors, NGS was performed. The mean KTR age at transplantation and the diagnosis of RCC was 50.3 years (median 54; 5–67 years) and 66 years (median 66; 24–79 years), respectively. The mean donor age at transplantation and graft age at RCC diagnosis was 39.7 years (median 42; 7–68 years) and 50.2 years (median 46; 20–83 years), respectively. The mean follow-up after RCC diagnosis was 47 months (median 39.1; 0–112 months). Papillary RCC was the most prevalent (n = 8), followed by clear cell RCC (n = 6) and unspecified RCC (n = 1). Thirteen RCCs were low-stage (pT1a/b) diseases, one was pT3, and one was of unknown stage. Most RCC was higher graded. No germline pathogenic cancer-predisposition variant was found in either KTR or donors except for several variants of uncertain significance.
ConclusionRCC of the transplanted kidney is very rare. Germline cancer-predisposition testing has identified several variants of uncertain significance, but no germline genetic predisposition to graft RCC in KTR. Further research is needed to assess the clinical relevance of genetic testing for cancer risk in KTR.
by Ahmad Sofi-Mahmudi, Eero Raittio, Yeganeh Khazaei, Javed Ashraf, Falk Schwendicke, Sergio E. Uribe, David Moher
BackgroundAccording to the FAIR principles (Findable, Accessible, Interoperable, and Reusable), scientific research data should be findable, accessible, interoperable, and reusable. The COVID-19 pandemic has led to massive research activities and an unprecedented number of topical publications in a short time. However, no evaluation has assessed whether this COVID-19-related research data has complied with FAIR principles (or FAIRness).
ObjectiveOur objective was to investigate the availability of open data in COVID-19-related research and to assess compliance with FAIRness.
MethodsWe conducted a comprehensive search and retrieved all open-access articles related to COVID-19 from journals indexed in PubMed, available in the Europe PubMed Central database, published from January 2020 through June 2023, using the metareadr package. Using rtransparent, a validated automated tool, we identified articles with links to their raw data hosted in a public repository. We then screened the link and included those repositories that included data specifically for their pertaining paper. Subsequently, we automatically assessed the adherence of the repositories to the FAIR principles using FAIRsFAIR Research Data Object Assessment Service (F-UJI) and rfuji package. The FAIR scores ranged from 1–22 and had four components. We reported descriptive analysis for each article type, journal category, and repository. We used linear regression models to find the most influential factors on the FAIRness of data.
Results5,700 URLs were included in the final analysis, sharing their data in a general-purpose repository. The mean (standard deviation, SD) level of compliance with FAIR metrics was 9.4 (4.88). The percentages of moderate or advanced compliance were as follows: Findability: 100.0%, Accessibility: 21.5%, Interoperability: 46.7%, and Reusability: 61.3%. The overall and component-wise monthly trends were consistent over the follow-up. Reviews (9.80, SD = 5.06, n = 160), articles in dental journals (13.67, SD = 3.51, n = 3) and Harvard Dataverse (15.79, SD = 3.65, n = 244) had the highest mean FAIRness scores, whereas letters (7.83, SD = 4.30, n = 55), articles in neuroscience journals (8.16, SD = 3.73, n = 63), and those deposited in GitHub (4.50, SD = 0.13, n = 2,152) showed the lowest scores. Regression models showed that the repository was the most influential factor on FAIRness scores (R2 = 0.809).
ConclusionThis paper underscored the potential for improvement across all facets of FAIR principles, specifically emphasizing Interoperability and Reusability in the data shared within general repositories during the COVID-19 pandemic.
To conceptualise experiences and perceptions of cancer nurses' potential for occupational exposure when dealing with cytotoxic drugs (CDs).
A mixed methods systematic review with framework synthesis.
A literature search was conducted in February 2022 in CINAHL PubMed, Web of Science, Ovid Nursing, and PsycINFO, and it was reported using the PRISMA guidance.
A synthesis of 38 studies revealed new categories of perceived solutions, side effects, and risky behaviour as well as three levels of experience and perception: individual, shared, and cultural, rather than the a priori theory.
The review conclude that individuals espouse safe handling and administration of CDs. Synthesis highlights a complex interplay between self-reported perception and the observed experience of potential occupational exposure to cytotoxic drugs.
The framework synthesis highlights the difference between the perception of espoused practice and the experience of practice. Observation and risk assessment must be used to enhance safe practice. Organisations must take seriously the perception and experience of the adverse effects of administering cytotoxic drugs to support cancer nurses.
Joanna Briggs Institute's (JBI) methodology for systematic reviews and framework synthesis indexed studies deductively and inductively.
No patient or public contribution.
PROSPERO: CRD42022289276
To generate, test and refine programme theories that emerged from a rapid realist review investigating practising UK Nurses' and Midwives' experiences of effective leadership strategies during the COVID-19 pandemic.
The realist review of literature generated six tentative theories of healthful leadership practices reflecting, working with people's beliefs and values; being facilitative; multiple means of communication and; practical support. The review yielded little insight into the actual impact of the leadership approaches advocated.
A realist study, informed by person-centredness using mixed-methods. Online survey (n = 328) and semi-structured interviews (n = 14) of nurses and midwives across the UK in different career positions/specialities. Quantitative data analysed using descriptive statistics and exploratory factor analysis. Framework analysis for qualitative data using context (C), mechanism (M), outcome (O) configurations of the tentative theories.
Three refined theories were identified concerning: Visibility and availability; embodying values and; knowing self. Healthful leadership practices are only achievable within organisational cultures that privilege well-being.
Leaders should intentionally adopt practices that promote well-being. ‘Knowing self’ as a leader, coaching and mentoring practice development is important for leadership development.
Nurses who feel valued, heard, cared for and safe are more likely to remain in clinical practice. Job satisfaction and being motivated to practice with confidence and competence will impact positively on patient outcomes.
The study addresses the role of leadership in developing healthful workplace cultures. The main findings were six leadership practices that promote healthful cultures. The research will have an impact on strategic and clinical leaders, nurses and midwives.
This study used EQUATOR checklist, RAMASES II as reporting standards for realist evaluations.
No patient or public contribution.