FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus fuentes RSS

Antipsychotics for Parkinsons disease: a protocol for a systematic review with network meta-analysis and trial sequential analysis

Por: Petersen · J. J. · Kamp · C. B. · Juul · S. · Bjerg · J. L. · Sillassen · C. D. B. · Faltermeier · P. · Salvesen · L. · Hejl · A.-M. · Bech · S. · Lokkegaard · A. · Jakobsen · J. C.
Introduction

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.

Methods and analysis

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 Published and unpublished randomised clinical trials comparing antipsychotics to any control (placebo, standard care or other antipsychotics) in patients with Parkinson’s disease will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.

Ethics and dissemination

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 registration number

PROSPERO ID: CRD42025633985. Available from https://www.crd.york.ac.uk/PROSPERO/view/CRD42025633985.

Cardiovascular effects of incretin-based drugs in patients with and without a history of heart failure: a protocol for a systematic review, meta-analysis and trial sequential analysis of randomised controlled trials

Por: El-Sheikh · M. · Sillassen · C. D. B. · Wisborg · F. D. · Hove · J. D. · Dirksen · C. · Lee · M. M. Y. · Jakobsen · J. C. · Grand · J.
Background

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).

Methods and analysis

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).

Ethics and dissemination

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.

PROSPERO registration number

CRD420251003374.

Transcranial direct current stimulation combined with physical exercise in knee osteoarthritis: a protocol for a randomised controlled clinical trial

Por: Lima · V. B. · Silva · C. A. M. · Silva · S. G. D. d. · Macedo · L. d. B. · de Souza · M. C. · Lins · C. A. d. A. · de Souza · C. G.
Introduction

Osteoarthritis (OA) is a degenerative and progressive joint condition causing pain and disability. Physical exercise is recognised as the most effective intervention since individuals with this condition often experience muscle weakness, balance deficits and chronic pain. Additionally, knee osteoarthritis (KOA) is associated with central sensitisation, contributing to chronic pain conditions. Transcranial Direct Current Stimulation (tDCS), a non-invasive neuromodulation technique, has been employed to induce changes in pain perception by altering cortical excitability, potentially reducing chronic pain.

Methods and analysis

This is a protocol for a randomised controlled trial. Participants will be allocated to two groups: G1 (active tDCS combined with exercise) and G2 (sham tDCS combined with exercise). The intervention protocol will last for 5 weeks, with two sessions per week on non-consecutive days. Pain intensity will be assessed as the primary outcome using the Numeric Rating Scale (NRS). The sample size was calculated based on a minimum clinically important difference of 3 points on the NRS between groups, with a statistical power of 80% and a significance level of 5%. Secondary outcomes will include physical function and global perceived change.

Ethics and dissemination

This protocol was approved by the Research Ethics Committee of the Trairi School of Health Sciences, Federal University of Rio Grande do Norte (Approval Number: 6.801.827), and it is in accordance with the Declaration of Helsinki for human research. Results will be published in peer-reviewed journals and presented at scientific events. This trial is registered in the Brazilian Clinical Trials Registry.

Trial registration number

Brazilian Clinical Trials Registry (RBR-5pb2g33).

Quality of care for people with chronic kidney disease: a systematic review and meta-analysis

Por: Ketema · D. B. · Wallace · H. · Hailu · W. · Badve · S. V. · Ronksley · P. · Neuen · B. L. · Pecoits-Filho · R. · Gallagher · M. · Kotwal · S. · Perkovic · V. · Joshi · R. · Jun · M.
Objectives

Guideline-based strategies to prevent chronic kidney disease (CKD) progression and complications are available, yet their implementation in clinical practice is uncertain. We aimed to synthesise the available evidence on the concordance of CKD care with clinical guidelines to identify gaps and inform future CKD care.

Design

Systematic review and meta-analysis.

Data sources, participants, and outcomes

We systematically searched MEDLINE (OVID), EMBASE (OVID) and CINAHL (EBSCOhost) (to 18 July 2025) for observational studies of adults with CKD reporting data on the quality of CKD care. We assessed data on quality indicators of CKD care across domains that related to patient monitoring (glomerular filtration rate and albuminuria), medications use (ACE inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), statins) and treatment targets (blood pressure (BP) and HbA1c). Pooled estimates (95% CI) of the percentage of patients who met the quality indicators for CKD care were estimated using random effects model.

Results

59 studies across 24 countries, including a total of 3 003 641 patients with CKD, were included. Across studies, 81.3% (95% CI: 75% to 87.6%) of patients received eGFR monitoring, 47.4% (95% CI: 40.0% to 54.7%) had albuminuria testing, and 90% (95% CI: 84.3% to 95.9%) had BP measured. ACEIs/ARBs were prescribed among 56.7% (95% CI: 51.5% to 62%), and statins among 56.6% (95% CI: 48.9% to 64.3%) of patients. BP (systolic BP ≤140/90 mm Hg) and HbA1c (

Conclusions

Current evidence shows substantial variation in CKD care quality globally. Guideline-concordant care varied according to quality measures and across patient groups, with gaps in indicators like albuminuria testing. These findings underscore the need for effective quality improvement strategies to address gaps in CKD care, including increased albuminuria testing for risk stratification, together with systematic measures for monitoring care quality.

PROSPERO registration number

CRD42023391749.

The Economic and societal burden associated with drug-resistant epilepsy in the Netherlands: an AIM@EPILEPSY burden-of-disease study protocol

Por: Elabbasy · D. · Evers · S. · Majoie · M. H. J. M. · Schijns · O. E. M. G. · MRabet · L. · van Kranen-Mastenbroek · V. H. J. M. · Eekers · D. B. P. · Houben · R. · Hendriks · M. · Colon · A. · van Mastrigt · G. A. P. G.
Background

Living with epilepsy, especially drug-resistant epilepsy (DRE), imposes several challenges for people diagnosed with the condition. These challenges include the physical and mental implications of epilepsy on both caregivers and patients with epilepsy. For the more than 120 000 individuals living with this neurological disorder in the Netherlands, along with their families, daily activities become hazardous, limited and costly, significantly affecting their health-related quality of life (HRQoL). As data on the burden of epilepsy in the Netherlands are lacking, studies attempting to capture the impact of epilepsy on individuals, caregivers and society are needed to enhance understanding and help address the burden of epileptic seizures.

Methods and analysis

The study is part of the AIM@EPILEPSY project. The project aims to develop a planning suite enabling cost-saving, minimally invasive treatment for epilepsy. By surveying 330 people with epilepsy and an anticipated sample of 150–200 informal caregivers across the Netherlands, using standardised questionnaires focusing on associated societal costs and the impact on HRQoL, this bottom-up, prevalence-based prospective study aims to understand the societal burden of DRE in the Netherlands. The data will be collected at 0, 3, 6 and 12 months of follow-up. The study results will describe the economic impact of epilepsy, focusing on cost-of-illness () and HRQoL (utilities) in the Netherlands.

Ethics and dissemination 

The proposed study was approved by the Maastricht University Medical Ethics Review Committee (Approval reference: FHML-REC/2024/067/Amendment/2024_16). The result of the study is planned to be published in a peer-reviewed journal and presented at international and local scientific conferences.

Geographical patterns of tuberculosis notification rates and their association with socioeconomic factors in Nepal: a spatial cross-sectional study (2020-2023)

Por: Mahato · R. K. · Htike · K. M. · Koro · A. B. · Sornlorm · K. · Yadav · R. K. · Kafle · A. · Sharma · V. · Singh · D. B. · Laohasiriwong · W.
Objectives

To identify the patterns of tuberculosis (TB) notification rates and examine their relationship with social and economic determinants in Nepal between 2020 and 2023.

Design

Cross-sectional study.

Setting

Nepal.

Participants

All TB cases across all ages.

Primary outcome

Prevalence of TB cases.

Methods

This cross-sectional spatial analysis used the data set of the National Tuberculosis Control Centre, Nepal, covering the Fiscal Year (FY) 2020–2021 to 2022–2023. Moran’s I and Local Indicators of Spatial Association were employed to detect the spatial autocorrelation between the prevalence of TB and associated social and demographic factors.

Results

The overall prevalence rate for TB in FY 2020–2021 was 98.08 per 100 000 population. This increased to 129.82 per 100 000 population in FY 2021–2022, followed by a slight decrease to 128.39 per 100 000 population in FY 2022–2023. The highest TB prevalence was observed in Kathmandu, with 146 cases per 100 000 population in 2020–2021, and in Dang district, the rate decreased from 215–191 per 100 000 population. We investigated the spatial patterns of TB prevalence and highlighted the geographic areas in each district in Nepal from 2021 to 2023 with Moran’s I of 0.558, 0.614 and 0.596, respectively. The consistent identification of High-High clusters in specific districts like Banke, Kapilbastu and Parsa across all 3 years periods highlighted persistent high-risk areas for TB transmission in Nepal.

Conclusions

This study emphasised the strong spatial associations and the complex, diverse aspects of TB transmission shaped by demographic and socioeconomic factors. Our results highlighted the need for tailored public health approaches that account for specific social determinants to address TB effectively.

Triple cardiovascular disease detection with an artificial intelligence-enabled stethoscope (TRICORDER): design and rationale for a decentralised, real-world cluster-randomised controlled trial and implementation study

Por: Kelshiker · M. A. · Bächtiger · P. · Mansell · J. · Kramer · D. B. · Nakhare · S. · Almonte · M. T. · Alrumayh · A. · Petri · C. F. · Peters · A. · Costelloe · C. · Falaschetti · E. · Barton · C. · Al-Lamee · R. · Majeed · A. · Plymen · C. M. · Peters · N. S.
Introduction

Early detection of cardiovascular disease in primary care is a public health priority, for which the clinical and cost-effectiveness of an artificial intelligence-enabled stethoscope that detects left ventricular systolic dysfunction, atrial fibrillation and cardiac murmurs is unproven but potentially transformative.

Methods and analysis

TRICORDER is a pragmatic, two-arm, multi-centre (decentralised), cluster-randomised controlled trial and implementation study. Up to 200 primary care practices in urban North West London and rural North Wales, UK, will be randomised to usual care or to have artificial intelligence-enabled stethoscopes available for use. Primary care clinicians will use the artificial intelligence-enabled stethoscopes at their own discretion, without patient-level inclusion or exclusion criteria. They will be supported to do so by a clinical guideline developed and approved by the regional health system executive board. Patient and outcome data will be captured from pooled primary and secondary care records, supplemented by qualitative and quantitative clinician surveys. The coprimary endpoints are (i) difference in the coded incidence (detection) of heart failure and (ii) difference in the ratio of coded incidence of heart failure via hospital admission versus community-based diagnostic pathways. Secondary endpoints include difference in the incidence of atrial fibrillation and valvular heart disease, cost-consequence differential, and prescription of guideline-directed medical therapy.

Ethics and dissemination

This trial has ethical approval from the UK Health Research Authority (23/LO/0051). Findings from this trial will be disseminated through publication of peer-reviewed manuscripts, presentations at scientific meetings and conferences with local and national stakeholders.

Trial registration number

NCT05987670

Building rural health research capacity: protocol for a realist review

Por: Young · C. · Patey · C. · Norman · P. · Geetha Manukumar · A. · Carson · D. B. · Swab · M. · Asghari · S.
Introduction

While individuals living in rural areas often have poorer health outcomes and reduced access to healthcare services compared with those in urban areas, there is a disproportionate gap in research examining rural health issues and identifying solutions to healthcare challenges. This is likely due to the numerous barriers to conducting rural health research, including the centralisation of research in urban areas and limited trained personnel and resources to conduct research in rural communities. This realist review aims to identify articles focused on building rural health research capacity and develop an evidence-based framework to be used by researchers, clinicians and policymakers to improve rural health services and well-being for rural populations.

Methods and analysis

We will conduct a realist review using the following steps: (1) develop a search strategy, (2) conduct article screening and study selection, (3) perform data extraction, quality appraisal and synthesis, (4) engage stakeholders for feedback on our findings and (5) report our findings and engage in knowledge translation. Search terms include variations of the terms ‘research’, ‘capacity building’ and ‘rural’. Databases include (since inception) Ovid MEDLINE, Embase, CINAHL Plus, APA PsycINFO, ERIC and Scopus. A separate search of the same databases was also designed to identify relevant theories or frameworks related to research capacity building, using variations of the terms ‘research’, "‘capacity building’, ‘theory’ and ‘framework’. Studies will be screened by title and abstract and full text by two research team members and included based on their relevance to rural health research capacity building. We will exclude articles not published in English. We will also search the grey literature to identify rural health research centres, networks or training programmes that have not been described in the academic literature. Two research team members will extract relevant data from included studies and perform a qualitative analysis based on guidelines for realist reviews.

Ethics and dissemination

This review does not require ethical approval as it draws on secondary data that is publicly available. The findings will be disseminated at academic conferences, published in peer-reviewed journals and summarised in a lay report for individuals interested in developing strategies, programmes or policies to improve rural health research. The results will inform individuals developing rural health research training programmes, establishing rural research centres, or others interested in building rural health research capacity.

PROSPERO registration number

CRD42023444072.

Adverse effects with tirzepatide: a protocol for a systematic review with meta-analysis and Trial Sequential Analysis

Por: Sillassen · C. D. B. · Petersen · J. J. · Kamp · C. B. · Grand · J. · Dominguez · H. · Frolich · A. · Gaede · P. H. · Gluud · C. · Mathiesen · O. · Jakobsen · J. C.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

This protocol does not present any results. Findings of this systematic review will be published in international peer-reviewed scientific journals.

PROSPERO registration number

CRD42024599035.

❌