Allostatic load modelling, lifestyle and cardiological risk factor: evidence for integrating patient profiling in the optimisation of pharmacological therapies during follow-ups in hospital setting – PLAY-UP cohort study protocol

Introduction
The allostatic load (AL) is a framework for conceptualising the physiological multisystemic impact of prolonged exposure to stress and its related side effects on mental health.
Stress due to AL can influence the development and outcomes of cardiovascular diseases. AL increases the risk of coronary and peripherical artery diseases. AL emerges from the detection of emotional dimensions related to the disease, low psychosocial functioning and high rates of psychopathological signs in patients with hypertension or coronary heart disease.

Method and analysis
The primary endpoint of the PLAY-UP protocol is the implementation of a multidimensional model underlying the clinical treatment of patients with cardiovascular disease through the integration of medical and psychological clinical variables.
PLAY-UP is a cohort study that will last for 24 months. 200 participants will be recruited and divided into three groups: early disease, midterm disease and long disease. All patients will undergo a clinical evaluation based on the detection of biological, medical and psychological indicators and variables. The evaluation battery will comprise three types of measurements: medical, psychological and pharmacological treatments. Clinical and psychological measurements will be processed in an integrated manner through the combination of all variables examined, elaborating the Allostatic Load Index from a longitudinal time perspective. The Allostatic Load Index will be calculated by measuring the z-score.

Ethics and dissemination
Ethical Committee Approval was obtained from CEtRA Abruzzo Region (IT) (ID 0461499/23). The results of the present project will be published in peer-reviewed journals, disseminated electronically and in print, and presented as abstracts and/or personal communications during national and international conferences.

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Novembre 2024

Patient Reported Outcome Measures in cancer care: a hybrid effectiveness-Implementation trial to optimise Symptom control and health service Experience (PROMISE)-protocol for a randomised controlled trial of electronic self-reporting of symptoms versus usual care during and following treatment in patients with cancer

Introduction
Routine collection of patient-reported outcome measures (PROMs) has the potential to inform and improve cancer care. It is now feasible for patients to complete PROMs electronically (ePROMs) providing information about their current levels of symptoms, side effects of treatment and other concerns. PROM scores can be tracked over time allowing more timely identification of problems and more appropriate intervention. Studies have reported clear benefits in patient–clinician communication when PROMs are used and trials in the USA and France found patients randomised to complete regular ePROMs reported better health-related quality of life, had fewer unplanned hospital visits and, importantly, significantly better survival than those randomised to usual care. However, information about the effects on health outcomes and, particularly, the cost-effectiveness of incorporating this information into practice is limited.

Methods and analysis
PROMISE (Patient Reported Outcome Measures in cancer care: a hybrid effectiveness-Implementation trial to optimise Symptom control and health service Experience) is a multicentre, randomised hybrid effectiveness/implementation trial to evaluate the clinical and cost-effectiveness of using ePROMs in routine cancer care to improve patient outcomes. Participants (target sample=572; randomised 1:1 to intervention and control) are adults aged 18 years or older diagnosed with a solid cancer and starting treatment at one of the four study hospitals. The primary outcomes are unplanned hospital presentations and physical/functional well-being at 6 months. We hypothesise that, compared with usual care, patients randomised to use an ePROM tool will have fewer unplanned hospital presentations, report better health-related quality of life and greater satisfaction with their care and that the ePROM tool will be cost-effective. We will also assess implementation and process outcomes consistent with the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) Framework.

Ethics and dissemination
This trial has been approved by the Metro South Human Research Ethics Committee (HREC/2020/QMS/67441). Participants provide written informed consent, including consent for record linkage, prior to completing the baseline questionnaire. Study results will be disseminated via peer-reviewed journals and presentations at scientific conferences and clinical meetings.

Trial registration number
ACTRN12620001290987.

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Novembre 2024

Exploring patient involvement in obstetrics and gynaecology education for medical students: a scoping review protocol

Introduction
It is important to incorporate the patient perspective into healthcare education, as we know that patients are experts in their own conditions. The expertise gained through lived experience serves to complement the theoretical knowledge that healthcare educators can provide. This scoping review aims to explore patient involvement in medical education within obstetrics and gynaecology, a specialty that can provide unique challenges and complexities to patient involvement due to its potentially highly sensitive and intimate nature. The goal of this study is to map the available literature on this topic which will allow for the identification of potential gaps in the provision of training for medical students in this field. The research also aims to highlight challenges that may be associated with patient involvement in this specialty in order to guide future initiatives.

Methods and analysis
The Joanna Briggs Institute scoping review framework and methodology will be used to guide and conduct this scoping review. A systematic search of electronic databases MEDLINE, CINAHL, Embase, Scopus, PsycINFO, ERIC, Google Scholar, Web of Science, African Journals Online, Cochrane Library and SciVerse will be carried out. Articles will be limited to the English language. No geographical limitations will be placed on the search. Literature from 1960 to 2023 will be considered for inclusion which corresponds with the first reports of patient educators used to assist with the demonstration of clinical skills in obstetrics and gynaecology. Relevant academic journals will be hand-searched for the previous 5 years. Identified studies will be screened by two independent reviewers and data extraction carried out by the primary researcher. Key findings will be presented in tables and summarised in narrative form. Findings from the review will be reported according to the PRISMA Extension for Scoping Reviews reporting checklist.

Ethics and dissemination
Ethical approval is not required for this study. The findings from the study will be submitted for publication in peer-reviewed journals and at medical education conferences.

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Novembre 2024

Efficacy and safety of electroacupuncture for metabolic dysfunction-associated fatty liver disease: a study protocol for a multicentre, randomised, sham acupuncture-controlled, patient-blinded clinical trial

Background
Metabolic dysfunction-associated fatty liver disease (MAFLD) is the most common chronic liver disease in the world and carries an increased risk of liver-related events, but no approved medicine. Electroacupuncture has been used to treat non-alcoholic fatty liver disease, but its effect was uncertain because of the poor quality of prior studies. We designed this trial to evaluate the efficacy and safety of electroacupuncture for MAFLD.

Methods/design
This is a multicentre, randomised, sham acupuncture-controlled, patient-blinded clinical trial. Participants will take part in a total of 20 weeks of study, containing three phases: a 4-week run-in period, 12-week treatment (36 sessions of acupuncture) and 4-week follow-up. A total of 144 eligible patients diagnosed with MAFLD will be randomly allocated to the electroacupuncture or sham acupuncture groups. The primary outcome is the percentage of relative liver fat reduction on the MRI proton density fat fraction from baseline to 12 weeks. Secondary outcomes include magnetic resonance elastography, liver and metabolic biomarkers, anthropometry parameters, blinding assessment, credibility and expectancy, and adverse events. All patients who receive randomisation will be included in the intent-to-treat analysis.

Discussion
The finding of this trial will provide evidence of the efficacy and safety of electroacupuncture for the treatment of MAFLD. The results of this study will be published in peer-reviewed journals.

Trial registration number
www.chictr.org.cn, ChiCTR2200060353. It was registered on 29 May 2022.

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Novembre 2024

Attitudes towards patient safety among physicians and nurses in Iranian governmental teaching hospitals: a cross-sectional survey

Objectives
To assess and compare attitudes towards patient safety among physicians and nurses in Iranian governmental teaching hospitals and to identify factors associated with attitudes towards patient safety.

Design
An institution-based, cross-sectional survey was carried out from July to August 2023.

Setting
10 governmental teaching hospitals in Tehran, Iran.

Participants
The study participants comprised a random sample of 186 nurses and 90 physicians who had worked for at least 6 months in their current hospitals.

Outcome measures
The primary outcome measures were mean and SD scores for individual items and the nine main patient safety domains assessed by the Attitudes Toward Patient Safety Questionnaire-III. The secondary outcome measure was the proportion of physicians and nurses who responded positively to each item, expressed as percentages for each group.

Results
Physicians and nurses exhibited moderately positive attitudes towards patient safety (mean scores of 3.79±0.33 and 3.83±0.36, respectively). Both professional groups reported the most positive attitudes in the same dimensions: ‘team functioning’ and ‘working hours as a cause for error’ (mean scores of >4 out of 5). Conversely, the lowest scores were observed in ‘importance of patient safety in the curriculum’, indicating potential gaps in their understanding of patient safety (mean scores of

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Novembre 2024