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Parkinson’s disease is a neurological disease with a rising incidence and prevalence. Patients with Parkinson’s disease may receive antipsychotics, for example, due to Parkinson’s disease psychosis. Parkinson’s disease psychosis is characterised by visual hallucinations and other psychotic symptoms. To date, no systematic review has evaluated the effects of antipsychotics in patients with Parkinson’s disease. Therefore, this review aims to assess the beneficial and harmful effects of antipsychotics for Parkinson’s disease.
This is a protocol for a systematic review. A search specialist will perform a search in major medical databases (eg, MEDLINE (Medical Literature Analysis and Retrieval System Online), EMBASE (Excerpta Medica database), CENTRAL (Cochrane Central Register of Controlled Trials)) and clinical trial registries. Published and unpublished randomised clinical trials comparing antipsychotics to any control (placebo, standard care or other antipsychotics) in patients with Parkinson’s disease will be included. Two review authors will independently extract data and conduct risk of bias assessments with the Cochrane Risk of Bias tool—V.2. Primary outcomes will be all-cause mortality, serious adverse events and significant falls. Secondary outcomes will be hospitalisations, non-serious adverse events, Unified Parkinson’s Disease Rating Scale total score and psychotic symptoms using any valid symptom scale. Data will be synthesised by aggregate meta-analysis, trial sequential analysis and network meta-analysis. Several subgroup analyses are planned. An eight-step procedure will be used to assess if the thresholds for clinical significance are crossed, and the certainty of the evidence will be assessed by GRADE (Grading of Recommendations Assessment, Development and Evaluations) and CiNeMA (Confidence in Network Meta-Analysis) approach.
This protocol does not include results, and ethics approval is not required for the project. The findings from the systematic review will be published in international peer-reviewed scientific journals.
PROSPERO ID: CRD42025633985. Available from https://www.crd.york.ac.uk/PROSPERO/view/CRD42025633985.
Gender-based violence is a worldwide health and social problem with negative short- and long-term health impacts. Sexual and gender minority people experience more gender-based violence and significant barriers to support. These populations are often not included in, or are actively excluded from, gender-based violence research, and sexual orientation and gender are generally poorly measured and reported. One recommendation put forth to improve the evidence base with regard to sexual and gender diversity is higher standards of research and reporting by academic journals. Given the leading role of nurse researchers in this area of women's health, this is a topic of particular importance for nursing research and education.
We examined the sexual and gender diversity-related guidance provided by academic violence journals to authors, editors and peer-reviewers.
We conducted a descriptive document analysis. Two researchers independently searched for, and coded, guidance related to sexual and gender diversity from 16 websites of academic journals focused on violence research.
While most journals included some mention of diversity or inclusion, only about half provided in-depth guidance for authors, editors and/or peer-reviewers. Guidance related to gender was more common than guidance for sexual diversity. The journals gave varied prominence to diversity-related guidance, and it was often difficult to locate.
To reflect the spectrum of lived experiences of gender and sexuality, publishers must actively direct authors, editors and reviewers to include, measure and report these experiences. This has not yet been fully achieved in the important area of gender-based violence research, and is of direct concern to nurse researchers who contribute significantly to this body of knowledge.
Incretin-based drugs, including glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RAs, are increasingly used in the management of type 2 diabetes mellitus and obesity. While these agents have shown cardiovascular benefits, their effects on both cardiovascular outcomes and cardiac structure and function remain uncertain—particularly in patients with and without a history of heart failure (HF).
We will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials (CENTRAL), Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica Database (EMBASE), Latin American and Caribbean Health Sciences Literature (LILACS), Science Citation Index Expanded (SCI-EXPANDED) and Conference Proceedings Citation Index-Science (CPCI-S)), as well as clinical trial registries from their inception and onwards to identify relevant randomised trials. The literature search is scheduled for July 2025. Two review authors will independently extract data and assess risk of bias. We will include randomised controlled trials assessing the effects of cagrilintide/semaglutide, liraglutide, semaglutide and tirzepatide in patients with and without a history of HF. The primary outcome will be cardiovascular mortality. Secondary outcomes will include HF hospitalisation, myocardial infarction, stroke, heart rate, systolic blood pressure, N-terminal pro B-type natriuretic peptide, left ventricular ejection fraction, left ventricular end-diastolic volume and left ventricular end-systolic volume. Data will be synthesised by aggregate data meta-analyses and trial sequential analysis. Risk of bias will be assessed with the Cochrane Risk of Bias tool, version 2, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations (GRADE).
As this study is a systematic review based on secondary analysis of published data, ethical approval is not required. Findings will be published in international peer-reviewed scientific journals.
CRD420251003374.
Sugar-sweetened beverages (SSBs) are sugary drinks such as sodas, fruit drinks and sweetened teas and are the leading source of added sugars in the American diet. SSBs are also linked to chronic diseases like type 2 diabetes, cardiovascular disease and certain cancers. Despite their well-known health risks, SSB consumption remains high in the United States of America (USA), with 63% of adults consuming them daily, often exceeding the recommended limit of 50 g of added sugar per day. Though efforts to reduce SSB intake through educational programmes, policy initiatives and taxes exist, further research is needed to assess the effectiveness of interventions to reduce SSB consumption in the USA. Understanding the role of behavioural interventions in lowering SSB consumption among adults is critical to address public health strategies.
The proposed scoping review will be conducted in accordance with the Joanna Briggs Institute methodological framework for scoping reviews. An advanced search will be conducted in three electronic databases: PubMed, PsycINFO and Scopus. The reference lists of included studies will also be reviewed to identify additional relevant literature. All identified citations will be compiled in EndNote, and duplicate citations will be eliminated. Identification of studies will occur through the three-step search process: (1) initial screening of studies according to inclusion criteria, (2) eligibility determined through full-text assessment and (3) inclusion of qualified studies meeting the criteria. To be included, studies must report on an existing behavioural intervention to reduce SSB consumption. All studies will undergo screening by two independent reviewers. Any disagreements that arise will be resolved through discussion or with an additional reviewer. A data extraction tool has been developed to extract relevant data from all eligible studies. The extracted data will be presented in a diagrammatic form, alongside a narrative summary, in line with Preferred Reporting Items for Systematic Reviews and Meta-Analysis: extension for Scoping Reviews reporting guidelines.
Ethics approval was not sought as all data will be collected from published literature. We will present our findings at relevant conferences and submit manuscripts for publication in peer-reviewed journals.
Non-communicable diseases (NCDs), such as diabetes, cardiovascular diseases and cancer, are major global public health concerns. Diet quality—particularly the consumption of ultra-processed foods—has been associated with increased risk of NCDs. Traditional cohort studies are often expensive and logistically complex. The NutriNet-Brasil cohort leverages a web-based approach, offering a cost-effective and practical solution for comprehensive data collection and long-term follow-up.
Recruitments began in January 2020 through mass media, social media campaigns and collaborations with health organisations. Eligible participants are adults (aged ≥18 years) living in Brazil with internet access. Participants complete self-administered online questionnaires covering dietary intake, health status and other health determinants. Dietary assessment is based on the Nova classification system, which categorises foods by their level of processing.
Over 88 000 participants have completed the initial questionnaire. The cohort is predominantly women (79.9%) and highly educated (67.9% had completed higher education). The web-based design enabled the development and application of innovative dietary assessment tools, including the Nova24h and the Nova24hScreener, specifically designed to evaluate food processing levels. These tools have shown good performance in capturing dietary patterns and are central to the cohort’s aim. The online platform facilitates efficient recruitment, data collection and participant retention.
NutriNet-Brasil is pioneering the development of web-based cohort methodologies and instruments tailored to food processing research. Future work includes leveraging collaborations with national and international research centres to conduct multidisciplinary analyses and inform public health policies.
Sarcopenia, osteoporosis and osteosarcopenia are conditions prevalent in ageing that impair muscle strength and bone density, increasing the risks of fractures, falls, disability and mortality. Recent studies highlight the benefits of milk protein supplementation (MPS) combined with exercises to improve musculoskeletal health in the older population. This systematic review protocol will enable the production of a compilation of evidence that will elucidate the effects of MPS combined with aerobic exercise, resistance exercise or both on the musculoskeletal function of older individuals with these three conditions.
Studies will be selected from electronic databases, including PubMed/MEDLINE, EMBASE, Scopus, Web of Science and the Cochrane Library, without restrictions on language or publication date. The outcomes evaluated will include muscle mass, muscle strength, BMD and physical performance after combined interventions of MPS and physical exercise of any type. The risk of bias will be assessed using the Cochrane Risk of Bias 2 tool. The Grading of Recommendations Assessment, Development and Evaluation approach will be used to classify the certainty of the evidence into four levels: high, moderate, low and very low. Meta-analysis will be performed given the homogeneity of the studies, using random effects methods in the face of the expected heterogeneity. The standardised mean difference (SMD) will be used for continuous data, and the I² index will assess heterogeneity (I² > 50%). Sensitivity analysis, ‘leave one out’ and a strategy for dealing with missing data will be carried out. Statistical analysis will be conducted using the STATA 18 software with a 95% CI and p
Formal ethical approval will not be required as primary data collection will not be performed. The results will be disseminated through peer-reviewed publications and presentations at conferences dedicated to the relevant field of study.
CRD42024555933.
We aimed to address an evidence gap by investigating the clinical impact of sex differences on long-term outcomes after primary percutaneous coronary intervention (pPCI) for acute ST-elevation myocardial infarction.
Systematic review and meta-analysis.
Medline, Scopus and EMBASE were searched through August 2024. Eligibility criteria for selecting studies. We included adjusted observational studies reporting HRs, comparing long-term clinical outcomes (beyond 1 year) between women and men undergoing pPCI for ST-elevation myocardial infarction.
Two independent reviewers extracted data and assessed risk of bias using the ROBINS I (Risk Of Bias In Non-randomised Studies - of Interventions) tool. Data were pooled using generic inverse-variance weighting, computing risk estimates with 95% CIs. Heterogeneity was assessed (Cochran Q statistic) and quantified (I2 statistic).
22 observational studies globally encompassing 358 140 patients (169 659 women vs 188 490 men) were included in the quantitative analysis. After a median follow-up of 3.3 years, no significant differences in terms of all-cause mortality were reported after multivariable adjustments (adjusted HR, adjHR 1.06, 95% CI 0.99 to 1.14, p=0.10). Women had a higher rate of cardiac death compared with men after multivariable adjustments (adjHR 1.86, 95% CI 1.25 to 2.77, p=0.002). No other significant differences in terms of recurrent MI, stent thrombosis and target vessel revascularisation persisted between women and men after multivariable adjustments.
Women undergoing pPCI for acute ST-elevation myocardial infarction experience an increased risk of cardiac death compared with men after a long-term follow-up.
CRD42024580932.
The prevalence of women with primary dysmenorrhoea is high and negatively impacts physical and mental health. The intense cyclic episodes of pain generate central nervous system dysfunctional processing. In this sense, strategies focused on the central nervous system are important to re-establish normal functioning. Home-based self-administered transcranial direct current stimulation (tDCS) emerges as a strategy to modulate dysfunctional brain areas and improve the symptoms. This protocol aims to evaluate the effects of home-based self-administered tDCS for pain, premenstrual symptoms, physical performance, quality of life, electroencephalography and patient global impression in women affected by primary dysmenorrhoea.
This is a single-centre, parallel, randomised, double-blinded clinical trial protocol. 40 women affected by primary dysmenorrhoea will be randomised into two groups (active-tDCS or sham-tDCS). Then, 20 consecutive sessions of home-based self-administered tDCS will be performed. The assessments will occur at five time points: baseline, after the 20th sessions, at the first, second and third cycles after tDCS interventions (follow-ups). Primary outcome will be pain according to visual analogue scale. Quality of life, premenstrual symptoms screening, depression, anxiety, physical performance, electroencephalography and participants’ satisfaction will be the secondary outcomes. A mixed analysis of variance will calculate the effect of stimulation.
The study was approved by the ethics committee of the Federal University of Rio Grande do Norte (No. 6.037.756) and registered in the Brazilian Clinical Trials Registry (n° RBR-747k8vb). Participants may withdraw at any time without penalty. Free support will be available from the lead researcher if needed. All procedures will follow Good Clinical Practice and international ethical standards.
The principal aim of this study was to investigate differences in the characteristics and physiological parameters of critically ill patients who underwent interhospital transportation.
Prospective observational cohort study.
Multicentre study within the Euregio Meuse-Rhine, including Dutch and German hospitals.
A representative sample of critically ill adult patients who underwent interhospital transport accompanied by a physician was included.
None.
Data on patient characteristics, transport logistics, interventions and adverse events were recorded using an online questionnaire. The cohort was divided into Dutch and German subsets and further stratified based on the transportation modality. Descriptive statistics were utilised to present the cohort characteristics.
Dutch patients (89%) were mainly transported by mobile intensive care unit (MICU). For the present investigation, in Germany, the Intensivtransportwagen was included in this MICU category, whereas German patients (48%) were mainly transported by intensive care ambulance (ICA). An intensivist accompanied most transports in the Netherlands, whereas various specialists transported patients in Germany. Interventions were primarily performed in the MICU for Dutch patients and in the ICA for German patients. Adverse events were reported in 5% of the cases.
These comprehensive data provide insights into the transportation differences of critically ill patients. This serves as a foundation for future investigations concerning the quality and efficacy of interhospital transportation.
This study was registered in the Dutch National Trial Registration (NTR4937).
Molar incisor hypomineralisation (MIH) is a qualitative developmental defect of the enamel with a complex, multifactorial nature and a significant genetic component. Individuals with MIH have a compromised stomatognathic system manifested by muscle hyperactivity under postural and dynamic conditions. However, there is a gap in knowledge on the specific functional abnormalities that these individuals experience. Early identification and intervention, with a focus on the prevention of orofacial dysfunctions and deviations in facial growth and development, are aspects of the utmost importance. Therefore, the aim of the proposed study is to perform a comparative analysis of orofacial functions with an emphasis on breathing and chewing patterns in individuals with and without MIH. The secondary objective is to assess whether dentin hypersensitivity and the severity of MIH lesions are associated with alterations in orofacial functions.
Assessments will be performed using the Nordic Orofacial Test-Screening (NOT-S). Descriptive analyses will characterise the sample. The Shapiro-Wilk test will assess normality. For normally distributed data, analysis of variance and Tukey’s post hoc test will be used. For non-normal data, the Mann-Whitney U test will be applied. The 2 test will analyse categorical variables and compare NOT-S domains between groups. Potential confounders (eg, age, sex, socioeconomic status) will be controlled through stratification or as covariates. Logistic and Poisson regressions will model associations for categorical and count-based outcomes, respectively. Statistical significance will be set at p
This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 83969924.2.0000.5511; approval date: 22 November 2024). Participants will agree to take part in the study by signing an informed consent form. The findings will be published in a peer-reviewed journal. The collected data will be available on request.
This study aimed to compare the perceptions of quality of life (QoL) and mental health among medical students and their peers in other university courses in Brazil through a cross-sectional analysis. We hypothesised that medical students face greater psychological challenges due to the demanding nature of their academic workload. Previous studies have indicated that medical training is associated with a decline in empathy and an increase in stress and anxiety, particularly during the clinical phase, when students face greater exposure to patient care and emotionally demanding experiences. These factors contribute to decreased psychological well-being, highlighting the need for targeted interventions in medical education. To address these challenges, this study investigates the specific impact of medical education on students’ mental health and QoL, aiming to identify potential structural changes that could mitigate these negative outcomes.
A cross-sectional study was conducted in private higher education institutions in Brazil.
Data were collected online via the QuestionPro platform in August 2024, encompassing 32 units located across 14 states and 4 geographic regions in Brazil.
The sample included 10 844 students, 33.7% of whom were enrolled in medicine and 66.3% in other fields (administration, agronomy, agribusiness, systems analysis and development, architecture, architecture and urbanism, biomedicine, computer science, accounting, economics, social communication/advertising and propaganda, law, physical education, nursing, civil engineering, computer engineering, production engineering, electrical engineering, mechatronics engineering, aesthetics and cosmics, pharmacy, physics, physiotherapy, speech, speech therapy, environmental management, commercial management, human resources management, financial management, history, Portuguese-English literature, logistics, marketing, mathematics, veterinary medicine, nutrition, dentistry, pedagogy, management processes, psychology, advertising and propaganda, computer networks, social work, information systems and theology). The inclusion criterion was as follows: regularly enrolled students. The exclusion criteria were refusal to provide consent and incomplete questionnaires.
The margin of error, calculated as 0.9 percentage points at a 95% CI, was based on a population of 74 684 students enrolled in the private institutions participating in the study.
Primary outcomes included QoL assessment via the WHOQOL-Brief Version and a customised questionnaire developed by the researchers. This questionnaire evaluated variables such as inclusion, accessibility, sports practices, adaptation and satisfaction with undergraduate training. Secondary outcomes assessed factors such as risky substance use, academic satisfaction and mental health conditions, including symptoms of anxiety and depression.
Medical students exhibited significant declines in physical QoL (64.5–57.1, p
This study reveals that medical students in Brazil experience a significant decline in QoL and mental health, particularly in the psychological and physical domains, as they progress through their academic journey. The higher prevalence of anxiety, depression and substance use among medical students than among peers in other fields underscores the intense emotional and academic pressures within medical education. These statistically significant findings highlight the critical need for comprehensive mental health support, curriculum adjustments to promote well-being and inclusive institutional policies. Implementing such measures is vital to enhance student welfare and foster resilient future healthcare professionals. Longitudinal research is necessary to assess the long-term impact of these interventions and to further explore systemic inequalities affecting student well-being.
Development of clinical skills in areas, such as exercise risk stratification, testing, prescription, monitoring and outcome assessment, is vital for patient safety and clinical effectiveness in clinical exercise physiology (CEP). This study explored how current CEP courses are being taught and assessed and to identify potential best practice recommendations from a variety of stakeholders
Qualitative methods were employed to explore the thoughts of CEPs, academics and current students regarding the teaching and assessment of CEPs in the UK. Research design involved (1) semistructured interviews with students (n=16) and (2) focus groups with academics (n=8) and CEP (n=5) stakeholders. Data obtained were audio recorded using a portable Dictaphone and transcribed verbatim, then thematically analysed manually.
Three themes: (1) in situ learning/real-world practice (working with patients and specialist practitioners); (2) programme design (scaffold learning and integrated modules) and (3) teaching approach (simulated learning and research competency) were generated concerning teaching methods and approaches across CEP postgraduate degrees. The current use of simulated tasks for the delivery of taught content was identified as lacking effectiveness, with clinical placements identified as being the most important source of knowledge and skill attainment due to the real-world exposure to patients and practitioners. Clinical placements and simulated learning were recognised as the two main methods of problem-based learning used to develop student knowledge, skills and competency to practice. Two themes (placement tariffs/assessors in situ and role play/simulation) were identified for the assessment of students.
Clinical placements remain the optimal method for developing the knowledge, skills and competency to practice for student CEPs. However, suitable placements remain limited, and novel approaches such as university-led exercise services require consideration for student competency development. A standardised and accredited training pathway from undergraduate through to postgraduate level should be explored to allow student competency to be developed over a longer period, to enhance knowledge, skills and competency on graduation and registration.
The coronary artery calcium (CAC) scan serves as a crucial tool in assessing the risk of coronary atherosclerosis in patients with hyperlipidaemia, particularly when there is ambiguity surrounding pharmacotherapy decisions. In addition to CAC, advanced glycation end products (AGEs), glycated proteins and lipids involved in ageing are emerging as markers for atherosclerosis. However, the relationship between AGEs score and CAC scores has not been evaluated to date. Our primary objective is to evaluate abnormal CAC scores in patients with low and borderline ASCVD risk and normal low-density lipoprotein cholesterol (LDL-C) levels ≤100 mg/dL. The secondary objective is to explore potential associations between CAC and AGEs scores.
We will retrospectively review health records of adult patients seen at the General Internal Medicine Executive Health Program (Mayo Clinic; Rochester, Minnesota) between 1 September 2023 and 31 March 2024, where all patients were offered the option of a baseline CAC scan. For our primary aim, we will determine the percentage of patients with low and borderline 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk, not receiving pharmacotherapy for hyperlipidaemia, who have LDL-C levels ≤100 mg/dL and have an abnormal CAC score. For our secondary aim, we will examine potential associations between CAC and AGEs scores.
This study was determined to be exempt from institutional review board approval (ID 24–0 03 921; 45 CFR 46.104d, category/subcategory 4(iii)) at the Mayo Clinic, Rochester. The findings of this study will be published in a peer-reviewed journal.
The combination of a reduction in the Danish hospital bed count, the shortage of hospital staff and demographic changes challenges the Danish hospital capacity. This was further highlighted during the COVID-19 pandemic when hospitals worldwide were overwhelmed by infected patients requiring acute hospital care. To address these challenges, a hospital-at-home (HaH) programme offers an alternative to conventional in-hospital admission. Furthermore, HaH has the potential to improve patient outcomes, reduce costs and increase patient satisfaction. However, few studies have evaluated HaH in a Scandinavian setting, and this article describes the protocol for a randomised controlled trial (RCT) comparing an HaH model with continued conventional in-hospital admission. The main aim of the trial is to evaluate physical activity level and mental wellbeing in patients admitted at home compared with conventionally admitted patients.
110 clinically stable patients from two internal medical wards at Nordsjaellands Hospital in Denmark will be included and randomised in a ratio of 1:1 to either continued conventional in-hospital admission (control group) or virtual HaH model (intervention group). The control group will receive standard hospital treatment, and the intervention group will be transferred home for continued treatment (eg, intravenous antibiotics or oxygen treatment). The primary outcome measures are physical activity assessed using daily step count (during the first 24 hours after inclusion, as an intermediary indicator of the risk of adverse events) and treatment satisfaction (assessed using a patient satisfaction survey). Secondary outcome measures are adverse events of special interest, escalation of care, readmission rate postdischarge (30 days and 90 days), mortality (associated and 7 days, 30 days and 90 days postdischarge), process data (eg, the number of teleconsultations) and a health economic evaluation.
The study was approved by the Danish Research Ethics Committees (no. 2303051) and the Danish Medicines Agency (CIV-23-03-042542) and will be monitored by the Copenhagen University Hospital Good Clinical Practice unit. Results will be published in peer-reviewed journals and presented at relevant national and international conferences. We also plan to communicate the results to relevant stakeholders in the Danish healthcare system.
Children with Medical Complexities (CMC) often require 24/7 expert care, which frequently necessitates prolonged (re)admissions to a university medical centre (UMC), thereby impeding discharge to home. The transition from hospital to home for CMC is a multifaceted process with numerous challenges and obstacles. This protocol describes the evaluation of an innovative transitional care unit (TCU), where families can stay together in a home-like environment between hospital and home. Under the supervision of healthcare professionals, parents are supported in preparing for a sustainable home situation. We hypothesise that an intermediate stay at the Jeroen Pit Huis (JPH) will have a favourable effect on healthcare consumption, patient, parent and family-relevant outcomes in comparison to discharge directly from a hospital ward to home. Therefore, the purpose of this study is to compare the transition via the TCU JPH versus transition from hospital ward to home as provided elsewhere for CMC patients in the Netherlands.
This observational prospective cohort study compares patients who transition directly from hospital to home with those who transition via the TCU. The control group comprises five UMCs in the Netherlands. Data will be collected by extracting information from electronic health records and through online questionnaires. Parents complete questionnaires at three time points: on discharge home, 3 months and 12 months postdischarge. Bayesian inverse probability weighting will be used to control for confounding effects and analyse the results.
Ethical approval was granted by the Amsterdam UMC Medical Ethics Committee (W20_220#20.007). The need for ethical approval was waived by all other participating UMCs. Results will be disseminated through peer-reviewed scientific journals and conference presentations. The insights gained from this study will contribute to the development of a national care pathway to enhance transitional care for CMC and their families in the future.
NCT06599398 (ClinicalTrials.gov) - Bridging Hospital to Home for CMC and Their Families.
Cardiovascular diseases remain the leading cause of mortality worldwide. Tirzepatide is approved for the treatment of type 2 diabetes mellitus and overweight and is increasingly used. The adverse effects with tirzepatide may not be disease-specific and have not been assessed previously.
We will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica database (EMBASE), Latin American and Caribbean Health Sciences Literature (LILACS), Science Citation Index Expanded (SCI-EXPANDED), Conference Proceedings Citation Index—Science (CPCI-S)) and clinical trial registries from their inception and onwards to identify relevant randomised clinical trials. We expect to conduct the literature search in January 2025. Two review authors will independently extract data and perform risk of bias assessments. We will include randomised clinical trials comparing tirzepatide versus placebo or no intervention in all patient groups with an increased risk of cardiovascular events. Primary outcomes will be all-cause mortality and serious adverse events. Secondary outcomes will be myocardial infarction, stroke, all-cause hospitalisation and non-serious adverse events. Data will be synthesised by meta-analyses and Trial Sequential Analysis, risk of bias will be assessed with the Cochrane Risk of Bias tool—version 2. We will systematically assess if the thresholds for statistical and clinical significance are crossed, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations.
This protocol does not present any results. Findings of this systematic review will be published in international peer-reviewed scientific journals.
CRD42024599035.
To provide evidence of the cost savings of a quality improvement (QI) initiative preventing healthcare-associated infections (HAIs) in critical care settings.
A micro-costing study focused on financial data related to a nationwide multicentric project preventing central line-associated bloodstream infection (CLABSI), ventilator-associated pneumonia (VAP) and catheter-associated urinary tract infection (CAUTI).
Brazilian public healthcare system.
Adult, paediatric and neonatal intensive care units (ICUs) participating in the QI initiative.
This collaborative QI project implemented a multifaceted strategy to enhance infection-control measures. Participating ICUs reported the number of patients with and without HAIs and information on each HAI’s aggregate average cost (AC), which was analysed following the Brazilian Ministry of Health’s micro-costing guidelines. The 1-year preintervention period evidenced an aggregated AC in adult, paediatric and neonatal ICUs, respectively, of Intl$21 763.5 (95% CI 20 683.6 to 22 843.0), Intl$34 062.4 (95% CI 25 819.6 to 42 304.9) and Intl$32 903.2 (95% CI 29 203.6 to 36 602.4) for CLABSI; Intl$25 202.5 (95% CI 24 276.6 to 26 127.8), Intl$44 753.6 and Intl$17 238.4 for VAP and Intl$19 166.3 (95% CI 17 676.2 to 20 656.1) and Intl$55 873.3 (95% CI 43 563.1 to 68 183.1) for CAUTI (not included neonatal ICUs).
The cost savings were estimated using the HAIs prevented—expenses avoided—during the QI intervention period from September 2021 to December 2023. The HAIs prevented were estimated using the difference between observed and predicted infections based on the aggregated preintervention baseline.
Of the 188 participating ICUs, 31 voluntarily completed and provided the requested financial data with 100% accuracy. Considering the prevented 7342 HAIs for adult, paediatric and neonatal ICUs, respectively: 1647, 86 and 205 CLABSI; 3775, 114 and 118 VAP; and 1377 and 20 CAUTI, we estimated a saving of Intl$175.3 million (95% CI 153.2 to 180.9 million) to the Brazilian unified health system and a resultant estimated return on investment (ROI) of 890%.
This QI collaborative is a value-based initiative preventing HAIs in adult, paediatric and neonatal ICUs in South American settings. The substantial cost savings and a remarkable ROI underscore the economic viability of investing in comprehensive QI infection prevention strategies.
Osteoarthritis (OA) is a multifactorial disease in which low-grade inflammation is considered to play a pivotal role. Although colchicine is a widely used anti-inflammatory drug in the treatment of gout, its effect in OA is still disputed due to inconsistent results of short-term clinical trials. Therefore, we aim to evaluate the effect of long-term colchicine 0.5 mg once daily on the incidence of knee or hip replacements in patients with knee or hip OA.
The ECHO trial is a prospective, multicentre, randomised, double-blind, placebo-controlled, phase III trial in which 1200 participants with knee or hip OA tolerant to colchicine during a 30-day run-in period will be 1:1 randomised to colchicine 0.5 mg once daily or matching placebo using concealed allocation. The primary endpoint is the time from randomisation to the first knee or hip replacement assessed up to 4.5 years. Secondary endpoints include course of pain, physical function, joint space narrowing, low-grade inflammation, quality of life, clinical or radiological onset of OA in a new joint group other than present at baseline, number of participants using pain medication during the study, onset of new cardiovascular events (ie, myocardial infarction, ischaemia-driven coronary revascularisation, ischaemic stroke, peripheral artery disease or cardiovascular death) and direct and indirect costs related to treatment and disease burden due to OA. Harm-related endpoints include the number of (serious) adverse events, the number of withdrawals due to (serious) adverse events and changes in laboratory data (ie, serum creatinine, estimated glomerular filtration rate and alanine transferase) throughout the study. The primary analysis will be performed according to the intention-to-treat principle.
This trial has been approved by the Medical Ethics Review Committee East-Netherlands. Findings will be presented at scientific meetings and published in a peer-reviewed scientific journal.
Huge advances in rheumatoid arthritis (RA) treatment mean an increasing number of patients now achieve disease remission. However, long-term treatments can carry side effects and associated financial costs. In addition, some patients still experience painful and debilitating disease flares, the mechanisms of which are poorly understood. High rates of flare and a lack of effective prediction tools can limit attempts at treatment withdrawal. The BIOlogical Factors that Limit sustAined Remission in rhEumatoid arthritis (BIO-FLARE) experimental medicine study was designed to study flare and remission immunobiology. Here, we present the clinical outcomes and predictors of drug-free remission and flare, and develop a prediction model to estimate flare risk.
BIO-FLARE was a multicentre, prospective, single-arm, open-label experimental medicine study conducted across seven National Health Service Trusts in the UK. Participants had established RA in clinical remission (disease activity score in 28 joints with C reactive protein (DAS28-CRP)
The intervention was disease-modifying anti-rheumatic drug cessation, followed by observation for 24 weeks or until flare, with clinical and immune monitoring.
The primary outcome measure was the proportion of participants experiencing a confirmed flare, defined as DAS28-CRP≥3.2 or DAS28-CRP≥2.4 twice within 2 weeks, and time to flare. Exploratory predictive modelling was also performed using multivariable Cox regression to understand risk factors for flare.
121 participants were recruited between September 2018 and December 2020. Flare rate by week 24 was 52.3% (95% CI 43.0 to 61.7), with a median (IQR) time to flare of 63 (41–96) days. Female sex, baseline methotrexate use, anti-citrullinated peptide antibody level and rheumatoid factor level were associated with flare. An exploratory prediction model incorporating these variables allowed estimation of flare risk, with acceptable classification (C index 0.709) and good calibration performance.
The rate of flare was approximately 50%. Several baseline clinical parameters were associated with flare. The BIO-FLARE study design provides a robust experimental medicine model for studying flare and remission immunobiology.
ISRCTN registry 16371380
In the context of global population ageing, there is a continuous and significant increase in the average age of nursing professionals. However, evidence indicates that age bias may hinder older workers’ access to the necessary support to remain active in the workforce.
This scoping review aims to map and characterise the scientific literature on age bias directed at older nursing professionals in the workplace, conducted using the Joanna Briggs Institute methodology for scoping reviews and aligned with the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. Databases include MEDLINE (PubMed), CINAHL (EBSCOhost), LILACS, Scopus, APA PsycInfo and grey literature in Google Scholar. Two independent reviewers will screen titles and abstracts, followed by a full-text review of potentially relevant articles. Another reviewer will reconcile discrepancies. Two independent reviewers will extract data from the included articles using a data extraction tool developed for this review. The results will be tabulated and presented in a diagram and/or tables and summarised to explicitly address the review’s objective.
Findings will be disseminated through professional networks, conference presentations and publication in a scientific journal.
FreshRSS 