Conectar
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 Published and unpublished randomised clinical trials comparing antipsychotics to any control (placebo, standard care or other antipsychotics) in patients with Parkinson’s disease will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.
To increase the sustainability of healthcare, clinical trials must assess the environmental impact of interventions alongside clinical outcomes. This should be guided by Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) extensions, which will be developed by The Implementing Climate and Environmental Outcomes in Trials Group. The objective of the scoping review is to describe the existing methods for reporting and measuring environmental outcomes in randomised trials. The results will be used to inform the future development of the SPIRIT and CONSORT extensions on environmental outcomes (SPIRIT-ICE and CONSORT-ICE).
This protocol outlines the methodology for a scoping review, which will be conducted in two distinct sections: (1) identifying any existing guidelines, reviews or methodological studies describing environmental impacts of interventions and (2) identifying how environmental outcomes are reported in randomised trial protocols and trial results. A search specialist will search major medical databases, reference lists of trial publications and clinical trial registries to identify relevant publications. Data from the included studies will be extracted independently by two review authors. Based on the results, a preliminary list of items for the SPIRIT and CONSORT extensions will be developed.
This study does not include any human participants, and ethics approval is not required according to the Declaration of Helsinki. The findings from the scoping review will be published in international peer-reviewed journals, and the findings will be used to inform the design of a Delphi survey of relevant stakeholders.
Registered with Open Science 28 of February 2025.
The WHO has declared climate change the defining public health challenge of the 21st century. Incorporating climate and environmental outcomes in randomised trials is essential for enhancing healthcare treatments’ sustainability and safeguarding global health. To implement such outcomes, it is necessary to establish a framework for unbiased and transparent planning and reporting. We aim to develop extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2025) and Consolidated Standards of Reporting Trials (CONSORT 2025) statements by introducing guidelines for reporting climate and environmental outcomes.
This is a protocol for SPIRIT and CONSORT extensions on reporting climate and environmental outcomes in randomised trials termed SPIRIT-Implementing Climate and Environmental (ICE) and CONSORT-ICE. The development of the extensions will consist of five phases: phase 1—project launch, phase 2—review of the literature, phase 3—Delphi survey, phase 4—consensus meeting and phase 5—dissemination and implementation. The phases are expected to overlap. The SPIRIT-ICE and CONSORT-ICE extensions will be developed in parallel. The extensions will guide researchers on how and what to report when assessing climate and environmental outcomes.
The protocol was submitted to the Danish Research Ethics Committees, Denmark in June 2025. Ethics approval is expected in September 2025. The SPIRIT and CONSORT extensions will be published in international peer-reviewed journals.
Fathers of preterm infants wish to be actively involved and attentive in caring for their children. The positive impacts of paternal caregiving on preterm infants’ cognitive and social development have been recognised. Awareness of the need to support fathers during early parenthood is increasing, but fathers may feel excluded when their infants are in the neonatal intensive care unit. Here, we present the protocol for a study involving the development and national implementation of a complex intervention supporting first-time fathers of preterm infants in early parenthood.
The study adheres to the Medical Research Council framework for complex interventions. A multicentre, prospective, non-blinded, quasi-experimental design will be applied to evaluate the effect of a clinical and technology-based intervention targeting both nurses and the fathers. Outcomes from participants enrolled during the control (2023–2024) and intervention (2025–2026) periods, comprising 295 fathers and their partners, will be compared. Effects on parental confidence, stress, depression and mood and family and reflective functioning as well as infants’ emotional and social development will be assessed. A comprehensive process evaluation will be applied using both qualitative and quantitative methods.
The study has been registered at Clinicaltrials.org [no. NCT0 6 116 747 (The SUPPORTED study – First-time Fathers of Preterm Infants), approved on 3 November 2023]. The Danish Data Protection Agency has approved the study (P-2022–792). The findings will be disseminated through peer-reviewed publications.
Given that low retention rates are a prevalent challenge in clinical trials, which ultimately affects trial validity, it is recommended that interventions be developed and evaluated to increase trial retention. In the context of trial retention, incorporating behavioural science is endorsed, as it provides a theoretical foundation for considering human behaviour. We hypothesised that an intervention informed by self-determination theory could increase retention in a randomised allergy trial on intralymphatic immunotherapy, as the support of basic psychological needs for autonomy, competence and relatedness is anticipated to lead to more sustained engagement and better outcomes.
To assess the acceptability and feasibility of the intervention and evaluation design, following the complex intervention framework by the Medical Research Council, before proceeding to a randomised evaluation.
A parallel two-arm randomised feasibility study was conducted within the randomised allergy trial.
All participants at one Danish site were eligible for recruitment.
The intervention was a web app informed by self-determination theory to support the basic psychological needs through its thoughtfully designed features. Participants were allocated unblinded across treatment groups to complete daily online questionnaires over a 100-day period from May to August 2022. All participants received a daily text message with a link for the questionnaires. On completion, participants in the control group received a confirmation message, while participants in the intervention group had a browser with the menu of the web app opened for them. The features within the menu were voluntary to use.
The prespecified assessments included evaluating the recruitment rate, retention rate (which reflected both sustained participation and the proportion of completed daily questionnaire entries), the suitability of outcome measures and the acceptability of the intervention and evaluation design to both participants and staff. Qualitative data were collected through a collaborative learning process with participants from the intervention group in November 2022.
A total of 30 participants were invited, randomly assigned 1:1 and analysed, resulting in a recruitment rate of 100%. None were lost to follow-up as all remained in the study for the entire duration. The response rate was 84.5% in the intervention group and 79.1% in the control group, indicating satisfactory retention. Outcome measures were deemed appropriate. No unintended adverse events were identified. The collaborative learning meetings involved three participants in the first meeting and two in the second, comprising a total of five different individuals. Participants found the intervention acceptable. They used it differently but agreed that its components were useful. Technical issues needed fixing, and voluntary free text boxes and registration of medication dosage should be added.
The intervention and evaluation design were assessed as acceptable and feasible. Technical issues were fixed, and additional response options were added before a randomised evaluation.
ILIT.NU: EudraCT 2020-001060-28. ClinicalTrials.gov NCT05191186.
To explore the experiences of significant others of patients with severe burn injury in the intensive care unit. Specifically, how severe burn injury impacted the significant other and their role within their loved one's life.
This qualitative study employed a Narrative Inquiry approach.
Interviews were undertaken during 2021–2022 with 17 participants who were the significant others of a patient with severe burn injury in the Intensive Care Unit. Recruitment occurred in New South Wales, Australia, from two tertiary hospitals providing care for people with major burns. A narrative inquiry approach was utilised, capturing stories through semi-structured interviews.
Significant others experienced necessary changes in their life in response to the catastrophe. These included advocating, being present and ensuring their loved one's needs were met, while often neglecting themselves. Significant others contemplated their future as a carer to their loved one with severe burn injury, and adjusting their own career, finances and lifestyle, often as a long-term measure. The shifting of their role to carer ultimately transformed and redefined their relationships and lives.
Significant others endure immense trauma when a loved one sustains a severe burn injury. They require support but prioritise the patient by virtue of their critical illness. The life of the significant other is changed as they take on the role of carer and provide support. It is, therefore, imperative that the support needs of significant others are recognised, understood and addressed to ensure their well-being while processing the trauma.
With increased understanding of the significant others' experiences, healthcare providers can adopt a consultative approach, where roles and boundaries can be clearly identified. Through this process, healthcare providers can strengthen rapport and provide targeted support for significant others, as they navigate this traumatic life-altering event.
No patient or public contribution.
Intrathoracic cancers, such as lung cancer, mesothelioma and thymoma, represent diagnostic challenges in primary care. We aimed to summarise evidence on the performance of imaging techniques that could aid the detection of intrathoracic cancers in low prevalence settings.
Systematic review and quality appraisal using Quality Assessment of Diagnostic Accuracy Studies-2 and Grading of Recommendations Assessment, Development and Evaluation.
MEDLINE, Embase and Web of Science were searched with a predesigned search strategy for articles from January 2000 to January 2024.
We included studies relevant for primary care, where participants were suspected of having intrathoracic cancer and reported on at least one diagnostic performance measure. We excluded studies where the cancer diagnosis was already established. Data extraction and synthesis screening were conducted independently by two reviewers. Data extraction and quality appraisal were conducted by one reviewer and checked by a second reviewer.
Out of 30 539 records identified by the database searches, 13 studies were included. There was heterogeneity in the types of cancers, populations included and reported diagnosis pathways for suspected cancers. Imaging modalities investigated included chest X-ray (three studies), computer tomography (CT, six studies), magnetic resonance imaging (two studies), positron emission tomography CT (two studies), ultrasound (two studies) and scintigraphy (one study). Chest X-ray sensitivity reported for lung cancer ranged from 33.3% to 75.9%, with specificity ranging from 83.2% to 95.5%. For CT, reported sensitivity varied from 58% for pleural malignancy to 100% for lung cancer. One study investigating an artificial intelligence tool to detect lung cancer found poor detection performance in a real-world patient cohort.
We found a limited number of studies reporting on the diagnostic performance of usual imaging techniques when used in unselected primary care settings for the diagnosis of intrathoracic cancer in symptomatic patients. There is a need for more studies evaluating such techniques in the general population presenting in primary care, where the prevalence is relatively low. A better understanding of the performance could lead to better detection strategies for intrathoracic cancers in primary care. Intrathoracic cancers, such as lung cancer, mesothelioma and thymoma, represent diagnostic challenges in primary care. We aimed to summarise evidence on the performance of imaging techniques that could aid the detection of intrathoracic cancers in low prevalence settings.
Scoping reviews, mapping reviews and evidence and gap maps (collectively known as ‘big picture reviews’) in health continue to gain popularity within the evidence ecosystem. These big-picture reviews are beneficial for policy-makers, guideline developers and researchers within the field of health for understanding the available evidence, characteristics, concepts and research gaps, which are often needed to support the development of policies, guidelines and practice. However, these reviews often face criticism related to poor and inconsistent methodological conduct and reporting. There is a need to understand which areas of these reviews require further methodological clarification and exploration. The aim of this project is to develop a research agenda for scoping reviews, mapping reviews and evidence and gap maps in health by identifying and prioritising specific research questions related to methodological uncertainties.
A modified e-Delphi process will be adopted. Participants (anticipated N=100) will include patients, clinicians, the public, researchers and others invested in creating a strategic research agenda for these reviews. This Delphi will be completed in four consecutive stages, including a survey collecting the methodological uncertainties for each of the big picture reviews, the development of research questions based on that survey and two further surveys and four workshops to prioritise the research questions.
This study was approved by the University of Adelaide Human Research Ethics Committee (H-2024-188). The results will be communicated through open-access peer-reviewed publications and conferences. Videos and infographics will be developed and placed on the JBI (previously Joanna Briggs Institute) Scoping Review Network webpage.
High-quality clinical practice guidelines and hospital standards on falls prevention and management now exist, yet their implementation into clinical practice is variable. Insights from consumers could help to guide the development of a process to improve the implementation of falls prevention and management, particularly in rehabilitation hospitals where fall rates are high.
A qualitative descriptive study will incorporate semistructured interviews and focus groups to explore the perspectives of hospital consumers on how hospital falls prevention evidence can best be implemented into rehabilitation practice. Thematic analysis of the data will be conducted in NVivo using a six-phase thematic coding process guided by Braun and Clarke. Evaluation and synthesis of the data will also follow the Consolidated Criteria for Reporting Qualitative Research checklist. Consideration of the results from the interviews and focus groups will provide insights into the views of people with lived experience of hospitalisation and falls. Thematic analysis will be supported by direct quotes for each key theme and will highlight how the themes relate to the study aims and the rehabilitation context.
The study was approved by La Trobe University Human Research Ethics Committee (HEC24526). The study will be published in a peer-reviewed journal, and findings will be presented at conferences, workshops and online events.
The increasing prevalence of chronic conditions and multimorbidity places a significant burden on patients and leads to increasing challenges for healthcare systems, especially in primary care. Recognising the multifaceted nature of chronic conditions, the Assessment of Burden of Chronic Conditions (ABCC) tool was developed to support person-centred care, by facilitating shared decision-making and self-management. This study aims to evaluate the cost-effectiveness of the ABCC tool in primary care.
This cost-effectiveness analysis was conducted over 18 months alongside a clustered, two-arm quasi-experimental study in primary care in the Netherlands.
The study included 231 participants diagnosed with chronic obstructive pulmonary disease (COPD), asthma, type 2 diabetes mellitus (T2DM) and/or chronic heart failure (CHF). Of these, 173 were assigned to the intervention group and 58 to the control group.
The intervention group was intended to incorporate the ABCC tool into routine consultations, while the control group had to continue care as usual.
Outcomes were assessed from a societal perspective, including quality-adjusted life years (QALYs) derived via the EuroQol-5D-5L (EQ-5D-5L) questionnaire. Costs were measured using adapted versions of the Productivity Costs Questionnaire (PCQ) and Medical Consumption Questionnaire (MCQ). Sensitivity analyses (SAs) included a healthcare perspective, per-protocol analysis (to account for disruptions caused by COVID-19) and exclusion of home care costs (to address extreme outliers). Moreover, all analyses were performed for well-being-adjusted life years (WALYs), derived from the ICEpop CAPability measure for Adults (ICECAP-A) questionnaire.
The ABCC tool was more expensive and effective than usual care, with an incremental cost-effectiveness ratio (ICER) of 64 525 per QALY and a 29% probability of cost-effectiveness. With the exception of the healthcare perspective, the SAs yielded more favourable outcomes in terms of cost-effectiveness, with ICERs (probability of cost-effectiveness) of 41 484 (31%), 8683 (58%) and 23 905 (48%) for a healthcare perspective, per-protocol analysis and exclusion of home care costs, respectively. Outcomes for QALY and WALY were comparable.
While the primary analysis suggested a relatively low probability of cost-effectiveness, the SAs showed higher probabilities. The per-protocol analysis suggested that the ABCC tool can be cost-effective when actually used.
Thousands of patients with mental illness are admitted to acute adult mental health wards every year in England, where local guidance recommends that all mental health settings be entirely smokefree. Mental health Trusts presently invest substantial effort and resources to implement smoke-free policies and to deliver tobacco dependence treatment to patients. Providing adequate support can help those who smoke remain abstinent or quit smoking during their smoke-free inpatient stay and beyond. At present, little is known about how best to support patients to prevent their return to pre-admission smoking behaviours after discharge from a smoke-free mental health inpatient stay. We have developed an intervention which includes targeted resources to support smoking-related behaviour change in patients following discharge from a smoke-free mental health setting. The aim of this trial is to determine the feasibility of a large-scale clinical trial to test the effectiveness and cost-effectiveness of the SCEPTRE intervention, compared with usual care.
This feasibility study will be an individually randomised, controlled trial in eight National Health Service mental health Trusts recruiting adults (≥18 years) admitted to an acute adult mental health inpatient setting who smoke tobacco on admission, or at any point during their inpatient stay. Consenting participants will be randomised to receive a 12-week intervention consisting of components aimed at promoting or maintaining positive smoking-related behaviour change following discharge from a smoke-free mental health inpatient setting or usual care. Data will be collected at baseline, 3 months and a second timepoint between 4 and 6 months post-randomisation. With 64 participants (32 in each group), the trial will allow a participation rate of 15% and completion rate of 80% to be estimated within a 95% CI of ±3% and ±10%, respectively. The analysis will be descriptive and follow a prespecified plan.
Ethics approval was obtained from the North West—Greater Manchester West Research Ethics Committee. We will share results widely through local, national and international academic, clinical and patient and public involvement networks. The results will be disseminated through conference presentations, peer-reviewed journals and will be published on the trial website: https://sceptreresearch.com/.
Mental health problems are important causes of disability and economic costs worldwide. Randomised clinical trials examining the treatment of mental health disorders measure heterogeneous outcomes, causing difficulties in data synthesis, interpretation and translation into clinical practice. The aim of the Patient Important Outcomes in Psychiatry (PIO-Psych) Initiative is to develop an overarching, transdiagnostic research-based and consensus-based core outcome set for adult mental health disorders.
The development of the PIO-Psych transdiagnostic core outcome set will include three phases: (1) a systematic scoping review of the literature to develop the initial list of outcomes for the Delphi study; (2) a Delphi study in three rounds including people with lived experience of mental health disorders and their relatives, clinicians, researchers and others (administrators, mental healthcare policymakers, philosophers); (3) a hybrid consensus meeting to agree on the final overarching, transdiagnostic core outcome set and corresponding time points of assessment of each outcome.
Ethical approval is not applicable to this study according to the Research Ethics Committee of the Capital Region of Denmark, as it is not an interventional study. All data will be reported anonymously, and it will not be possible to identify study participants. Results will be disseminated via stakeholder and research networks and peer-reviewed publications.
The PIO-Psych Initiative was pre-registered with COMET (Core Outcome Measures for Effectiveness Trials) on 17 May 2024 (https://www.comet-initiative.org/Studies/Details/3125).
Referrals for gender-affirming healthcare services have surged in recent decades, presumably driven by increased visibility, acceptance and reduced barriers to care. Despite these advances, transgender and gender-diverse individuals continue to face significant mental health challenges, including elevated rates of anxiety, depression as well as high prevalence of autistic traits. Gender-affirming hormonal treatment (GAHT) has been suggested to improve mental health and quality of life (QoL) among transgender individuals; however, the short- and long-term treatment effects of GAHT are not yet fully understood. Therefore, this study aims to establish a comprehensive cohort of transgender individuals at the Centre for Gender Identity (CGI), Aalborg University Hospital, Denmark, to enhance understanding and treatment outcomes.
The Transgender Cohort (TraCK) will recruit participants from February 14, 2024, with recruitment occurring continuously alongside yearly follow-up. This single-centre cohort study will include both retrospective and prospective data collection. Transgender individuals referred to CGI will be invited to participate in the study via the Danish digital mail system called e-Boks. Participants must provide informed consent and complete a baseline questionnaire. Data will be collected from self-reported questionnaires and medical records across multiple specialists. Self-reported questionnaires include WHO-Quality of Life BREF, Eating Disorders Examination Questionnaire, Autism Spectrum Quotient, Transgender Congruence Scale, and Gender Minority Stress and Resilience Measure. Medical records will provide information on demographics, mental health, physical health, and gender-affirming treatment details. Data will be managed using REDCap, ensuring compliance with GDPR and the National Data Protection Act.
While recognising the potential privacy risks associated with data collection, the study considers these outweighed by the benefits of advancing knowledge on gender diversity and the impacts of gender-affirming care. The North Jutland Region Ethics Committee reviewed the project, determining no formal approval was needed, but it was registered and approved (no. F2024-012) by the North Jutland Region. Findings will be disseminated through peer-reviewed journals, conferences, and accessible reports for participants.
This study is registered with the North Jutland Region (no. F2024-012). Recruitment and data collection began on February 14, 2024, and will continue alongside yearly follow-up. Keywords Transgender individuals, transgender and gender-diverse, transgender cohort, transgender health, transgender research, cohort study, gender-affirming care.
Targeted oxygenation protocols in mechanically ventilated patients are critical in avoiding the deleterious effects of hypoxaemia and hyperoxaemia. Peripheral oxygen saturation (SpO2) is a practical metric that commonly drives oxygen titration protocols and guidelines but has inaccuracies attributable to patient variability that can lead to occult hypoxaemia. Conversely, arterial oxygen saturation (SaO2) offers accuracy but is costly and invasive. We aim to develop a novel approach to targeted oxygenation that collectively uses the accuracy of SaO2 and the feasibility of SpO2 to mitigate occult hypoxaemia and prevent hyperoxaemia.
The Optimization of Inspired Oxygen during Mechanical Ventilation trial is a pragmatic stepped wedge, open label, cluster-randomised controlled trial of an algorithm-based SpO2-SaO2 electronic alert-based oxygen titration protocol. The intervention arm includes targeted oxygenation via an electronic SpO2-SaO2 driven alert protocol. The control group will be subjected to oxygen titration according to standard practice. Within the intervention arm, patients will be assigned to groups with different SpO2 targets based on the degree of SpO2-SaO2 difference. In the ‘Conserve O2’ group, where SpO2
The protocol was approved by The Ohio State University Institutional Review Board (Protocol # 2023H0016) and is registered at ClinicalTrials.gov (NCT 05923853). Progress and safety of the trial are monitored by an independent Data and Safety Monitoring Board. Study results will be published in peer-reviewed medical journals. This study is being carried out with a waiver of consent as participation in the study presents no more than minimal incremental risk compared with routine clinical care for mechanically ventilated critically ill adults outside of the study.
To evaluate the completeness of reporting of simulation studies on responder analysis methods and simulation performance.
Systematic methodological survey.
We searched Embase, MEDLINE (via Ovid), PubMed and Web of Science Core Collection from inception to 9 October 2023.
We included simulation studies comparing responder analysis methods and assessing simulation performance (bias, accuracy, precision or variance, power, type I and II errors and coverage).
Two independent reviewers extracted data and assessed simulation performance. We used descriptive analyses to summarise reporting quality and simulation performance.
We identified seven simulation studies exploring augmented binary methods, distributional methods and model-based methods. No studies reported the starting seed, occurrence of failures during simulations, the random number generator used and the number of simulations. No studies reported simulation accuracy. Responder analysis results were not significantly influenced by covariate adjustment. Distributional methods remained adaptable even with skewed data. Compared with standard binary methods, augmented binary methods generated increased power and precision. When the threshold is in the tail of the distribution, a simple asymptotic Bayesian (SAB) distributional approach may not reduce uncertainty but can improve precision.
Simulation studies comparing responder analysis methods exhibit suboptimal reporting quality. Compared with standard binary methods, augmented binary methods, distributional methods and model-based methods may be better choices, but there is no best one.
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.
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.
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.
Among lower extremity artery disease (LEAD), symptomatic carotid stenosis (SCS) and abdominal aortic aneurysm (AAA), the disease burden is insufficiently illuminated from a patient and societal perspective. Such knowledge is central to identifying patients at risk of poorer outcomes. Therefore, the Danish Vascular (DanVasc) survey aims to describe self-reported health status, health literacy, medication adherence and loneliness, including changes over time, and investigate characteristics associated with worse self-reported health at baseline and their associations with poorer outcomes within 1 year (healthcare utilisation and mortality) in patients with LEAD, SCS and AAA.
The DanVasc survey, a national prospective cohort study combining survey data measured at several time points with register-based data, includes validated patient-reported outcome measures (PROMs) and ancillary questions developed with patient representatives. Our baseline survey (T0) follows the index contact in vascular outpatient clinics with follow-up surveys determined by the patient’s trajectory: (1) newly referred patients in conservative treatment trajectories; the date for the outpatient visit activates 1-month (T1), 3-month (T2) and 12-month (T3) follow-ups. (2) Patients referred for vascular surgery; the surgery date activates 1-month (T1), 3-month (T2) and 12-month (T3) follow-ups. The included PROMs assess health-related quality of life (HRQoL), anxiety and depression, sleep, frailty status, health literacy, medication adherence and loneliness. For LEAD, a disease-specific PROM evaluates HRQoL. For AAA, disease-specific ancillary questions are added. Additionally, the DanVasc survey includes questions on health behaviour, preventive measures and sexual life. The DanVasc survey will be linked to national registries to obtain socio-demographic information and data on redeemed prescriptions, clinical information, healthcare utilisation, comorbidities and mortality. From December 2023 to December 2024, we aim to recruit approximately 5500 patients from all seven DanVasc surgery departments. Patient characteristics will be reported using descriptive statistics. Changes over time and factors associated with poorer health outcomes will be analysed using linear, logistic and Cox proportional hazard models, presented as univariate and multivariate regressions.
Approval for the collection of medical record data was granted by the Central Denmark Region, acting on behalf of all Danish regions (record 1-45-70-94-22). Consent to participate is obtained prior to answering the survey. Results will be disseminated through peer-reviewed scientific publications and conference presentations, and findings will be shared with patients and relevant stakeholders via public and social media.
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.
Increasing awareness of the high frequency, wide spectrum and disabling nature of symptoms that can persist following COVID-19 infection has prompted the investigation of management strategies. Our study aims to determine the effectiveness of atorvastatin on cognitive function, physical activity, mood, health-related quality of life and features of neurovascular impairment and neuroinflammation in adults with ongoing neurological symptoms after COVID-19 infection.
The STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy study is an ongoing international, investigator-initiated and conducted, multicentre, prospective, randomised, open label, blinded endpoint trial with fixed time points for outcome assessments. A total of 410 participants with long covid neurological symptoms were planned to be randomly assigned to either the intervention group to receive 40 mg atorvastatin for 12 months or to a control group of no treatment, on top of usual care.
This study protocol was designed, implemented and reported, in accordance with the International Conference on Harmonisation guidelines for Good Clinical Practice, the National Health and Medical Research Council of Australia, the National Statement on Ethical Conduct in Human Research and with the ethical principles laid down in the World Medical Association Declaration of Helsinki. Central ethics committee approval was obtained from Sydney Local Health District Royal Prince Alfred Hospital Ethics (No: X21-0113 and 2021/ETH00777 10) in Australia. Site-specific ethics committee approvals were obtained elsewhere before any local study activities. All participants provided written informed consent.
The study protocol is registered at Clinicaltrials.gov (NCT04904536).
FreshRSS 