Self-advocacy is associated with positive health outcomes, which is a central issue in chronic disease management. This study attempted to define self-advocacy operationally and conduct a mixed-methods analysis of self-advocacy among stroke patients in China.

Schwartz-Barcott and Kim’s method was used to clarify the concept of self-advocacy.

Two hospitals in Zhengzhou and Luoyang City, Henan Province, China.

A total of 12 stroke patients were recruited and interviewed face to face from October 2023 to December 2023.

A three-phase method (theoretical phase, fieldwork phase and final analysis phase) was employed to conduct the mixed concept analysis. In the theoretical phase, a literature search was conducted using PubMed, Web of Science, EBSCO, Embase, PsycINFO, CNKI, Wanfang database, VIP database and CBMdisc. 38 articles in databases were evaluated without time limits up to August 2023. In the fieldwork phase, semistructured interviews were used to interview the 12 participants who were chosen using purposive sampling. In the final analysis phase, the results from both the initial and second phases were integrated.

The review of literature in the theoretical phase determined the attributes of the concept, including ‘self-cognition’, ‘self-decision making’, ‘effective communication’, ‘social connection’. In the field study phase, attributes such as ‘self-awareness’, ‘self-care knowledge and abilities’ and ‘seeking support’ were added. In the final analysis phase, self-advocacy was finally defined as five attributes: ‘self-awareness’, ‘self-care level’, ‘self-decision-making’, ‘effective communication’ and ‘seeking support’.

Self-advocacy was defined as the capacity of stroke patients to comprehend and articulate their personal needs and care preferences, make proactive and meaningful decisions, engage in effective communication with healthcare providers and derive strength by seeking support from others.

Patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA) are considered to have a symptomatic venous thromboembolism (VTE) risk of 1.0%–1.5% despite thromboprophylaxis. Fast-track treatment protocols have substantially lowered the VTE risk in most patients. Hence, the majority of patients may be unnecessarily exposed to the burden and risk of thromboprophylaxis. On the contrary, there are still patients with a high VTE risk who develop VTE despite thromboprophylaxis. Thus, tailored thromboprophylaxis treatment may potentially reduce both VTE and bleeding risk.

The DISTINCT (inDividual, targeted thrombosIS prophylaxis versus the standard ‘one-size-fits-all’ approach in patients undergoing Total hIp or total kNee replaCemenT) trial is a national, multicentre, randomised, multiarm, open-label trial. The main objective is to study whether tailored thromboprophylaxis reduces the occurrence of symptomatic VTE (primary outcome) and major bleeding (primary safety outcome) within 90 days after THA/TKA in comparison with standard thromboprophylaxis. Patients with a low, intermediate or high predicted VTE risk (based on the Thrombosis Risk Prediction following total hip and knee arthroplasty score (TRiP(plasty) score)) will be included in the DISTINCT-1, DISTINCT-2 or DISTINCT-3 studies, respectively. In the DISTINCT-1 trial, 3478 patients will be randomly allocated to receive either in-hospital thromboprophylaxis or standard prophylaxis. In the DISTINCT-2 cohort study, 2500 patients will receive standard prophylaxis. In the DISTINCT-3 trial, 4100 patients will be randomly allocated to receive either 6 weeks of high-dose thromboprophylaxis or standard prophylaxis. Standard prophylaxis consists of a low dose of any approved thromboprophylactic agent for 4 weeks. We hypothesise that (1) the efficacy of in-hospital only thromboprophylaxis is non-inferior in preventing VTE and equally safe compared with standard prophylaxis in patients with a low VTE risk (DISTINCT-1) and (2) prolonged high-dose thromboprophylaxis is superior in preventing VTE as compared with standard prophylaxis in patients with a high VTE risk (DISTINCT-3). Patients with intermediate VTE risk will be observed to evaluate VTE and bleeding rates (DISTINCT-2).

The protocol has been approved by the Medical Research Ethics Committee Leiden-Den Haag-Delft, EU-trial-number 2023-510186-98. Study results will be disseminated through peer-reviewed journals and during international conferences.

NCT06581965.

Vaccination has been an effective public health intervention for immunising individuals against many common communicable and non-communicable diseases. However, there is limited information on the efficacy of vaccination among patients undergoing dialysis or patients with chronic kidney disease (CKD). The objective of this review is to assess the effectiveness of vaccination within dialysis and CKD patient populations.

This will be a systematic review of studies assessing the effectiveness of vaccination among CKD and dialysis patients. Relevant studies will be identified using MEDLINE, Embase, Scopus and Cochrane Library. All searches will be conducted from database inception to October 2025. Only observational studies such as cohort, prospective, retrospective and cross-sectional studies will be included. Data pertaining to patient outcomes and study design will be extracted. A narrative synthesis will be conducted as well as a meta-analysis if data permitting this analysis is extracted from included studies.

Since data collection will be conducted by examining existing studies, no ethical approval or consent will be required. The results of this review will be published in a peer-reviewed journal as well as presented at seminars, conferences and symposiums.

This review protocol has been registered in International Prospective Register of Systematic Reviews (PROSPERO), registration number CRD42025648534.

Informal caregivers play a vital role in caring for individuals who choose to spend the end of their life at home. However, this caregiving role often imposes considerable physical, emotional, social and financial burdens that can negatively impact caregivers’ quality of life. A comprehensive understanding of the breadth of interventions designed to support caregivers of individuals receiving home-based palliative and end-of-life care is essential, along with insights into how these interventions are perceived by those who have received them. The objective of this review is to synthesise existing evidence on the effectiveness and appropriateness of interventions that support informal caregivers of patients receiving home-based palliative care in order to address the caregivers’ needs and improve their quality of life. Additionally, this review aims to explore the acceptability and perceived benefits of these interventions from the perspectives of informal caregivers who have received them.

A comprehensive search will be performed in the following databases: MEDLINE (PubMed), CINAHL, PsycINFO, Web of Science, Scopus, Cairn.info, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL). This review will include studies that focus on adult informal caregivers of adult patients with serious life-threatening illnesses receiving home-based palliative care. Interventional studies that employed quantitative, qualitative and mixed-methods approaches will be considered. Quantitative studies will include randomised controlled trials (RCTs) and experimental and quasi-experimental designs. Qualitative studies will encompass research that explores informal caregivers’ experiences with the interventions, perceived benefits and barriers and enablers influencing intervention effectiveness. Mixed-methods studies using convergent, embedded or sequential designs will also be included.

The search will include studies published in English or French, with no restrictions on the publication period. Study selection, critical appraisal and data extraction will be conducted independently by two reviewers to ensure methodological rigour. This review will adhere to the Joanna Briggs Institute guidelines for mixed-methods systematic reviews, using a convergent segregated approach. Findings will be reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines.

Ethical review is not required for this study, as it is a literature review that does not involve the collection of primary data. The findings of this review will be disseminated to the scientific community through conference presentations and peer-reviewed publications. Additionally, lay summaries will be prepared and shared with the general public and relevant stakeholders.

PROSPERO, registration number CRD420251006612.

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.

Approximately, 20 million older adults undergo major elective surgery annually, yet less than 10% engage in advance care planning (ACP). This is a critical missed opportunity to optimally engage in patient-aligned medical decisions and communications in the perioperative setting. The PREPARE ACP programme (easy-to-read advance directives (ADs) and a patient-directed, online ACP programme) has been shown to increase ACP documentation and patient and clinician empowerment to discuss ACP. Yet, a gap remains in extending PREPARE’s use to surgical populations. We hypothesise that by delivering PREPARE in a patient-facing electronic health record (EHR) centric presurgery workflow for older adults, supported by automated patient reminders and outreach from a healthcare navigator (HCN), we can enable patients and/or surgical teams to engage in ACP discussions.

This is a three-site, single-blinded, pragmatic randomised trial comparing increasing intensity of ACP-focused, patient-facing EHR messaging and HCN support. The outreach occurs prior to a new presurgical clinic visit. We will enrol 6000 patients (2000 each site) aged 65 and older and randomise them equally to the following study arms: (Arm 1) ACP-related cover letter and PREPARE URL information sent via patient portal and postal mail (includes cover letter, AD and PREPARE pamphlet); (Arm 2) Arm 1 plus reminder message via text or MyChart message and (Arm 3) Arm 2 plus HCN outreach and support. The primary outcome is clinically meaningful ACP documentation in the EHR (ie, surrogate designation, documented discussions and ADs) within 6 months of the new surgical visit. The rate of ACP documentation will be compared between treatment groups using generalised estimating equations. Secondary outcomes include a validated four-item ACP engagement survey, administered 2 weeks after the presurgical visit and 6 months later. All analyses will follow the intention-to-treat principle and recent Consolidated Standards of Reporting Trials guidelines.

The study will be conducted according to the Declaration of Helsinki, Protection of Human Volunteers (21 Code of Federal Regulations (CFR) 50), Institutional Review Boards (21 CFR 56) and Obligations of Clinical Investigators (21 CFR 312). The protocol and consent form were reviewed and approved by Advarra, an National Insitutes of Health (NIH)-approved, commercial, centralised Institutional Review Board (IRB). The IRB/Independent Ethics Committee of each participating centre reviewed and approved the protocol and consent and obtained reliance agreements with Advarra prior to study initiation. The study is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of the study will be disseminated to both academic and community stakeholders, complying with all applicable privacy laws.

ClinicalTrials.gov ID: NCT06090552.

Advarra Pro 00070994.

23-38948.

Protocol Date: 24 October 2024. Protocol Version: 4.

Adolescence and youth are periods of significant maturational changes, which seem to involve greater susceptibility to disruptive events in the brain, such as binge drinking (BD). This pattern—characterised by repeated episodes of alcohol intoxication—is of particular concern, as it has been associated with significant alterations in the developing brain. Recent evidence indicates that alcohol may also induce changes in gut microbiota composition and that such disturbances can lead to impairments in both brain function and behaviour. Moreover, there is evidence suggesting that microbiota-targeted interventions (psychobiotics) may help mitigate alcohol-induced damage in individuals with chronic alcohol use, positively influencing cognitive and brain functioning. However, the triadic relationship between BD, gut microbiota and brain structure/function, as well as the therapeutic potential of gut microbiota-targeted interventions in young binge drinkers, remains largely unexplored.

This double-blind, parallel, randomised controlled study aims to evaluate whether a BD pattern disrupts gut microbiota diversity in young college students (primary outcome). Additionally, it seeks to determine whether alcohol-induced alterations in the microbial composition and function are associated with immunological, cognitive, neurostructural and neurofunctional impairments (secondary outcomes). A total of 82 college students (36 non/low drinkers and 46 binge drinkers (BDs)), matched for age and sex, will be recruited from the University of Minho (Portugal). During the pre-intervention phase, all participants will undergo a comprehensive assessment protocol, including gut microbiota profiling, measurement of inflammatory markers, neuropsychological testing and structural and functional MRI. BDs will then be randomly assigned to a 6-week intervention with either a prebiotic (inulin) or a placebo (maltodextrin). Post-intervention assessment will mirror the baseline protocol, and craving and alcohol use will be monitored for 3 months.

The present protocol was approved by the Ethics Committee for Social and Human Sciences of the University of Minho (CEICSH 078/2022), ensuring compliance with national and international ethical guidelines, including the Declaration of Helsinki. Participation is voluntary and preceded by informed consent, with confidentiality and data processing safeguarded in accordance with the General Data Protection Regulation. All procedures are safe and non-invasive, and the prebiotics used are recognised as food ingredients in Europe, hold Generally Recognized as Safe status in the USA and are classified as dietary fibres by the Food and Drug Administration. Findings will be disseminated in national and international scientific forums, with preference for publication in open-access, peer-reviewed journals.

NCT05946083

Digital therapeutics (DTx) show promise in bridging mental healthcare gaps. However, treatment selection often relies on availability and trial-and-error, prolonging suffering and increasing costs. Personalised prediction models could help identify individuals benefiting most from specific DTx.

The aim of this secondary analysis was to establish a machine learning-based prediction model for positive treatment outcomes in patients with depressive or anxiety symptoms after 8 weeks of internet-delivered cognitive behavioural therapy (iCBT).

We analysed a large real-world dataset of patients from the online therapy unit iCBT programme in Saskatchewan, Canada (2013–2021). Clinically significant changes in depressive symptoms or anxiety were measured using the Patient Health Questionnaire-9 (PHQ-9) and the Generalised Anxiety Disorder-7 (GAD-7). We trained six prediction models using sociodemographic and mental health-related factors at baseline, compared model performances and calculated Shapley values for feature importance.

Data from 4175 patients using 34 features for prediction, identified by least absolute shrinkage and selection operator regression, showed the Gradient Boosted Model (gbm) and logistic regression (log) performed best, with balanced accuracies of 0.76, 95% CI (0.70 to 0.83) and 0.70, 95% CI (0.63 to 0.77). Shapley values indicated GAD-7 scores at baseline as the most important predictor of clinically significant improvement, along with mental health history and sociodemographic variables.

The gbm and log models achieved comparable accuracy in predicting clinically significant improvement after iCBT, supporting the use of simpler, interpretable methods in clinical practice.

These findings could help improve mental health treatment selection, iCBT assignment, enhance effectiveness and optimise treatment for patients.

NCT05758285.

Fostering well-being and positive mental states are major aims of many strategies for the promotion of public mental health. Such strategies become increasingly important since many people worldwide suffer from psychological distress and mental disorders, resulting in substantial individual and societal costs. Within the last years, there is a shift from strategies solely focusing on the reduction of mental distress to those also aiming at the promotion of positive mental states. Correlates, that is, psychosocial resources, of positive mental states may represent a starting point for those interventions. To date, a comprehensive systematic review on those correlates is still missing as well as knowledge on culture-related differences.

A systematic review and meta-analysis on the longitudinal link between psychosocial resources (eg, income, optimism, social support and community coherence) and hedonic and eudaimonic positive mental states (eg, life satisfaction, happiness and forward-looking attitude) will be conducted. Using Hofstede’s dimensions of culture and global metrics of Education, Industrialisation, Richness and Democratic values (EIRDness), we will examine culture-related moderators of these associations. The systematic review will be conducted following standards of the Cochrane Collaboration and will be reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyse guidelines. Literature searches for primary studies will be carried out across four databases (APA PsycNet, Embase, Scopus and the Web of Science Core Collection), including all publications up to 27 January 2025. Screening at the level of titles and abstracts will be performed with the help of artificial intelligence software (ASReview). Study quality will be assessed using an adapted version of the Newcastle Ottawa Scale. We will employ multilevel meta-analyses of correlation coefficients, with cultural variables being examined as moderators.

This systematic review does not require ethics approval, as it solely uses previously published data. Materials and data used for this review will be shared via open repositories (https://osf.io/2xkhs/). Results will be published in an international, peer-reviewed journal and presented at conferences including plain language summaries.

https://doi.org/10.17605/OSF.IO/K7X52