Prognostic nutritional index in the prediction of adverse cardiac and cerebrovascular events in ST-segment elevation myocardial infarction patients with type 2 diabetes mellitus in Urumqi, China: a retrospective cohort study

Objective
Prognostic nutritional index (PNI) is an index for assessing nutritional and immune status. The aim of this study is to investigate the predictive value of PNI for long-term major adverse cardiac and cerebrovascular events (MACCE) in ST-segment elevation myocardial infarction (STEMI) patients with type 2 diabetes mellitus (T2DM).

Design, setting and participants
This retrospective cohort study analysed 1582 STEMI patients with T2DM who underwent percutaneous coronary intervention from January 2015 to June 2023 in Urumqi, China. Patients were followed up for MACCE.

Primary and secondary outcome measures
The primary endpoint was new-onset MACCE including all-cause death, non-fatal MI and non-fatal stroke.

Results
This study ultimately included 1582 patients for analysis with a median follow-up period of 48 months (IQR: 24–84 months) and 282 patients (17.8%) developed MACCE. Of them, 138 (8.7%), 84 (5.3%) and 60 (3.8%) patients developed all-cause death, a non-fatal MI and a non-fatal stroke, respectively. Incidences of MACCE and all-cause death conversely correlated with PNI. Kaplan-Meier curves showed a significant difference in all components of MACCE between PNI quartiles (p

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[Viewpoint] Patient-reported outcomes (PROs) as personalised cancer care: report from a 2023 Australian consensus meeting (PROActive)

This viewpoint reports on the outcomes of the 2023 Australian interest holder meeting on the use of patient-reported outcomes (PROs) in cancer care and discusses its findings in the context of the significant national investment into the collection of PRO data in Australia. The interest holders emphasised the importance for PRO data collection to be relevant to the care of individual patients and personalised to their needs and preferences to ensure direct impact on patients’ care and outcomes. They also prioritised the coordination and integration of various PRO collection efforts to improve patient outcomes and care quality.

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Protocol for 'Re: CBT Dialysis: a realist evaluation–why, for whom and in what circumstances does cognitive behaviour therapy work for people with depressive symptoms receiving dialysis?

Introduction
Nearly 40% of adults receiving life-saving dialysis for kidney failure report depressive symptoms. With more than 40 000 Canadians on dialysis, this is a significant health burden. Cognitive behavioural therapy (CBT) has been shown to be effective for treating depressive symptoms; however, it is rarely considered or used for people receiving dialysis. The aim of this realist study is to evaluate and explain how, why, for whom and in what circumstances therapist-guided and remotely delivered CBT works in order to provide equitable mental healthcare to individuals with depressive symptoms receiving dialysis.

Methods and analysis
The project will include a realist synthesis, a quantitative cohort study and a realist evaluation. Realist methodology is a theory-driven approach that seeks to explain how generative mechanisms are shaped by contextual features, giving rise to outcome patterns. We will begin by developing an initial programme theory (IPT) from the literature and interviews with CBT therapists to understand how CBT is intended to work and for whom. We will use data from the quantitative cohort study to identify contexts that may shape outcome patterns in CBT for people receiving dialysis. This includes previously collected survey data and data from a longitudinal cohort study, both sourced from people across Canada undergoing dialysis. We will test and refine the IPT using data from a realist evaluation and existing literature. The realist evaluation will involve participants from the quantitative cohort study who received therapist-guided, remotely delivered CBT.

Ethics and dissemination
Ethical approvals have been granted. We have planned a wide range of dissemination strategies: journal manuscripts and conference presentations, executive memos for administrators of renal programmes in Canada, an online inventory of resources for depressive symptoms and presentations of findings together with patient partners at all participating sites.

PROSPERO registration number
CRD42023476184.

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Patient-Reported Incident Measure (PRIM) tools for reporting patient safety incidents: protocol for a scoping review

Introduction
Patient safety incidents during healthcare cause a high burden and mortality, but many go unreported. Involving patients and caregivers in the identification and reporting of safety incidents would add value to the current incident reporting systems used by health professionals. Identifying and analysing patient safety incidents is essential to prevent future events, allowing organisations to apply a learning-from-error approach and to implement improvement plans. Patient-Reported Incident Measures are tools for patients and caregivers to report safety issues related to their healthcare. In accordance with WHO’s patient safety taxonomy, the term patient safety incidents is used throughout this protocol to encompass events that do and do not reach the patient, including what are commonly referred to as near misses and adverse events. We aim to identify and describe the published literature about tools for patients or caregivers to report patient safety incidents in healthcare.

Methods and analysis
We will conduct a scoping review. We have developed inclusion criteria using the PCC (population, concept and context) format, where population includes adult patients or caregivers; concept refers to documents describing formal tools used to report patient safety incidents; and context includes any healthcare setting, such as hospitals or mental health centres, during or immediately after care. The scoping review will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines. Evidence sources include primary research, systematic reviews, meta-analyses, conference abstracts, letters, guidelines, as well as policy documents, reports, blogs and websites, without language restriction. An initial database search in Medline, Embase, CINAHL, and Cochrane Library from database inception up to June 2023 identified 4500 initial citations, of which 4103 were selected for evaluation after duplicates were removed. We will supplement the search by checking the reference lists of included studies for additional sources of evidence and an additional search in Google to identify non-peer-reviewed documents. This initial search will be updated before completing the review. We will use a self-created data collection form for data extraction and perform a narrative synthesis to integrate and summarise the review findings. We will describe the general characteristics of the tool: setting, scope, format, content, type of patient safety incident and severity, the moment of notification, relation to patient safety incident reporting and learning systems, development process, testing, validation, or piloting, among other characteristics. As a result of this scoping review, we intend to provide an index of patient/caregiver-reported safety notification tools and a list of descriptive or evaluation studies.

Ethics and dissemination
We will only use published data. Approval from the human research ethics committee is not required. The results of this scoping review will be submitted for publication in an international peer-reviewed journal and scientific meetings. Findings will also be disseminated through digital science platforms and academic social media.

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Understanding disparities in access to and quality of surgical care for African, Caribbean and Black communities in high-income countries with universal healthcare: a scoping review protocol

Introduction
African, Caribbean and Black (ACB) communities experience disparities in health outcomes, with higher rates of chronic diseases, such as heart disease and stroke, and lower self-reported health status compared to their White counterparts. Barriers to timely access to healthcare services further exacerbate these inequities. Some studies link racialisation to surgical disparities and subpar surgical outcomes. However, the findings are diverse, and there is no synthesis of the evidence on disparities in surgical care for ACB patients in high-income countries with universal healthcare systems. The objective of the scoping review is to systematically describe, characterise and map the existing literature on disparities in the access to and quality of surgical care among ACB patients in high-income countries with universal healthcare systems, and to identify gaps in the literature on surgical access and quality of surgical care in ACB patients.

Methods and analysis
The scoping review will follow the Joanna Briggs Institute methodology and report according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. The search strategy will be customised for each database (MEDLINE, Embase, CINAHL, APA PsycINFO and Cochrane Library) using terms for ACB and surgery. Grey literature and references from included studies will be searched for additional sources, with no limitations on publication date or language. All study designs will be eligible. Two independent reviewers will screen titles, abstracts and full texts in duplicate for eligibility. One reviewer will chart data, with a second reviewer validating the data charted. The findings will be synthesised, quantitatively summarised using descriptive statistics and qualitatively analysed through thematic analysis.

Ethics and dissemination
Ethics approval is not required as the study utilises published data. The dissemination of the findings will inform future research and improve understanding of the surgical care experiences of ACB patients. Dissemination will target academics and healthcare professionals through publications, presentations and workshops.

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Estimating diagnostic delay in patients with pituitary adenomas in Sweden: a cross-sectional study

Objective
A delayed diagnosis of pituitary adenomas (PAs) can lead to increased morbidity and reduced quality of life. The aim was to estimate diagnostic delay and investigate the concordance between patient-reported symptoms and the medical record documentation in patients with PA.

Design
Cross-sectional study.

Setting
Seven university hospitals.

Participants
654 patients: non-functioning PA (NFPA, 314), prolactinoma (118), acromegaly (164) and Cushing’s Disease (CD, 58).

Data collection
Questionnaires and medical record extraction.

Primary and secondary outcomes
Type of first healthcare contact, delay of PA diagnosis and patient-reported symptoms and symptoms documented in medical records.

Results
First healthcare contact was usually a general practitioner. Estimated time from symptoms to diagnosis varied from 10 years (9%). The longest diagnostic delays were observed in acromegaly and CD. A longer delay was observed in women compared with men (p0.6) and for menstrual irregularities in prolactinomas (Cohen’s kappa >0.7).

Conclusion
We report a large variation in symptom duration before diagnosis with a substantial diagnostic delay in patients with CD and acromegaly. An increased awareness about endocrine diseases in the general population and health professionals may contribute to earlier diagnosis of pituitary adenomas.

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Treatment burden and medication adherence among older patients in comprehensive specialised hospitals in the Amhara Region in Ethiopia: a multicentre, cross-sectional study

Objectives
Due to numerous comorbidities, complicated medical regimens and age-related difficulties, older adults frequently confront substantial treatment burdens and poor medication adherence, which could result in poor health outcomes. This study assessed the treatment burden and medication adherence among older adults in comprehensive specialised hospitals in the Amhara Region in Ethiopia.

Design
A multicentre hospital-based cross-sectional study was conducted from 30 March to 30 July 2024.

Setting
The study was conducted at four comprehensive specialised hospitals in Northwest Ethiopia.

Participants
Patients were ≥65 years old, diagnosed with two chronic illnesses and were receiving medical attention for the relevant issue.

Outcome measures
This study employed the Multimorbidity Treatment Burden Questionnaire to assess treatment burden and the General Medication Adherence Scale to assess medication adherence. Data analysis was conducted using STATA version 17. Linear and binary logistic regressions were used to analyse the dependent variables of treatment burden and medication adherence to the determining factors, respectively.

Results
422 patients took part in this study. Regarding treatment burden, 75% report a high burden. Of the patients, 32.20% adhered well, whereas 67.80% did not. The medication regimen complexity index (MRCI; β=0.029, 95% CI 0.001 to 0.058; p=0.047), age (β=0.027, 95% CI 0.009 to 0.044; p=0.004) and number of medications (β=0.168, 95% CI 0.045 to 0.291; p=0.007) were associated with higher treatment burden. Variables associated with medication non-adherence included rural residence (adjusted OR 2.249, 95% CI, 1.356 to 3.732; p=0.002), care provided by relatives (1.744, 1.055 to 2.883; p=0.030), moderate Charlson comorbidity index (CCI; 2.241, 1.220 to 4.117; p=0.009), severe CCI (6.953, 3.526 to 13.715; p=0.000), polypharmacy (1.615, 1.055 to 3.230; p=0.044) and treatment burden (1.501, 1.023 to 3.090; p=0.015).

Conclusion
Of the older adult patients enrolled in this study, three-quarters had a high treatment burden, and more than two-thirds had poor adherence. A high treatment burden was associated with age, medication use and MRCI, whereas non-adherence was associated with self-management, residency, CCI, medication use, MRCI and treatment burden.

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Impact of 2014 Japanese practice guidelines on treatment patterns in patients with myasthenia gravis: an insurance claims database study

Objectives
To evaluate changes in oral corticosteroid (OCS) use after the publication of the 2014 Japanese clinical practice guidelines for myasthenia gravis (MG).

Design
Retrospective cohort study performed in three Japanese health insurance databases: the JMDC database between 2005 and 2021; the DeSC database covering the National Health Insurance (NHI) and the DeSC database covering the Late-Stage Elderly Healthcare Service (LSEHS) between 2014 and 2021. Achievement of OCS ≤5 mg/day was defined as ≥90 days of consecutive OCS ≤5 mg/day during follow-up, without any gap longer than 60 days between two consecutive claims. The time to achieve OCS ≤5 mg/day was estimated using Kaplan-Meier survival analysis.

Setting
Real-world treatment setting in Japan.

Participants
Patients aged ≥16 years with a record of MG (International Classification of Diseases 10th edition code: G70.0) with a serological test, who had baseline period ≥180 days before inclusion with no MG claim and who started immunotherapy (including OCS) within 90 days of MG diagnosis.

Outcome measures
Prescription of OCS and other therapies for MG.

Results
Overall, 811 patients were included. The mean age was 49 years in the JMDC, 61 years in the NHI and 80 years in the LSEHS. In the JMDC, the median time to achieve OCS ≤5 mg/day was significantly shorter (p=0.042; log-rank test) in patients included in 2015 or later (11.0 months) than in patients included before 2015 (17.9 months). The median time to achieve OCS ≤5 mg/day was shorter in the LSEHS (6.5 months) than in the JMDC (11.0 months) and the NHI (11.7 months).

Conclusions
Faster tapering of the OCS dose was observed in patients starting treatment after the publication of the 2014 guidelines, although use of higher-dose OCS remained widespread after this date. This highlights the need to improve awareness of guidelines by healthcare providers in order to decrease the burden of higher-dose OCS.

Trial registration number
Clinical Trials Registry (UMIN-CTR): UMIN000051155; Post-results.

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Exploring cognitive function and postoperative neurocognitive recovery after cardiac surgery in older adults (ECPON): a protocol for an observational study

Introduction
Cardiovascular disease is one of the most common health issues facing the older population, and the number of older adults undergoing cardiac surgery is expected to increase. Postoperative neurocognitive impairment is a frequent and often unrecognised complication that can adversely affect a patient’s recovery, quality of life and daily activities, as well as impact the lives of their family members. Patients may express cognitive difficulties as a feeling of ‘not being the same since the operation’. This study aims to investigate the factors that influence neurocognitive function and patient-reported cognitive symptoms among patients aged 65 and older following cardiac surgery, and explore the impact on the overall postoperative recovery. Additionally, the study aims to describe the perspectives of close relatives on the recovery process.

Methods and analysis
A longitudinal observational study with a mixed-methods approach will be conducted in two thoracic surgical departments in Sweden. A total of 220 patients and 1 close relative for each patient will participate. Neurocognitive function will be assessed preoperatively and at 1, 3 and 6 months postoperatively using a digitalised neurocognitive test battery. We will also evaluate postoperative patient-reported cognitive symptoms and signs, delirium, frailty, health-related quality of life, depression, perceived self-efficacy, fatigue and functional capacity. Each patient’s close relative will assess the observed cognitive function and report on caregiver burden. At the 6-month mark, a purposive sample of patients and their close relatives will be interviewed to explore their experiences of postoperative cognitive recovery.

Ethics and dissemination
The study has been approved by the Swedish Ethical Review Authority (Reference number: 2024-03380-01) and will adhere to the Helsinki Declaration and its amendments. The results will be disseminated through peer-reviewed journals and scientific conferences, as well as presented in various popular science forums and patient organisations.

Trial registration number
NCT06469515; Pre-results.

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Associations of educational level with ECG-derived cardiovascular ageing in a population-based cohort: a mediation analysis from the Tromso Study

Objective
To assess the association between educational level and cardiovascular age acceleration metric derived from ECG, and to determine whether this association is mediated by established cardiovascular disease (CVD) risk factors.

Design
Prospective population-based cohort study (the Tromsø Study).

Setting
General population of the Tromsø municipality, Norway.

Participants
The study sample consisted of 4367 participants of the Tromsø Study, who took part in both Tromsø6 (2007–2008) and Tromsø7 (2015–2016), had a 12-lead ECG obtained at Tromsø7 and did not report a history of heart attack, stroke or atrial fibrillation.

Primary outcome measures
-age, a biomarker of cardiovascular ageing, is defined as the difference (in years) between an individual’s ECG-predicted heart age and their chronological age. ECG-predicted heart age was estimated using a previously validated deep neural network.

Results
Our findings indicate an inverse association between education and -age, with a regression coefficient per increment increase in education of –0.24 (95% CI –0.41 to –0.07) in the overall sample, –0.38 (95% CI –0.59 to –0.16) for women and –0.04 (95% CI –0.31 to 0.23) for men. Participants with the highest level of education (university/college for 4 or more years) had the lowest estimated -age with a regression coefficient of –0.69 years (95% CI –1.23 to –0.16) compared with the group with primary education for the overall sample, –1.05 years (95% CI –1.73 to –0.37) for women and –0.15 years (95% CI –1.03 to 0.73) for men. CVD risk factors mediated up to 75% of the association between overall education and -age, and 80% of the association among those with the highest education level (university/college for 4 or more years). Among women, 50% of the effect of overall education on -age was mediated by CVD risk factors, rising to 53% in the category with the highest level of education. However, in the subsample of men, there was no significant association between education and -age, and the mediation analysis produced natural direct and indirect effects pointing in opposite directions.

Conclusions
Cardiovascular ageing is inversely associated with educational level, an effect that appears to be largely mediated through established risk factors.

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Development of prediction models for screening depression and anxiety using smartphone and wearable-based digital phenotyping: protocol for the Smartphone and Wearable Assessment for Real-Time Screening of Depression and Anxiety (SWARTS-DA) observational study in Korea

Introduction
Depression and anxiety are highly prevalent mental health conditions that significantly affect quality of life and cause societal burdens. However, their detection and diagnosis rates remain low owing to the limitations of the current screening methods. With rapid technological advancements and the proliferation of consumer-grade wearable devices and smartphones, their integration into digital phenotyping research has enabled the unobtrusive screening for depression and anxiety in natural settings. The Smartphone and Wearable Assessment for Real-Time Screening of Depression and Anxiety study aims to develop prediction algorithms to identify individuals at risk for depressive and anxiety disorders, as well as those with mild-to-severe levels of either condition or both. By collecting comprehensive data using smartphones and smartwatches, this study aims to facilitate the translation of artificial intelligence-based early detection research into clinical impact, thereby potentially enhancing patient care through more accurate and timely interventions.

Methods and analysis
This cross-sectional observational study will enrol up to 2500 participants (at least 1000) aged 19-59 years from South Korea via social media outreach and clinical referrals. The eligible participants must use a compatible smartphone. Each participant will be followed up for 4 weeks. Data will be collected using a custom-developed smartphone application called PixelMood. Active data collection will include daily, weekly and monthly self-report questionnaires incorporating validated scales, such as the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7. Passive data from smartphones include information on physical activity, location, ambient light and smartphone usage patterns. Optionally, participants using the Apple Watch or Galaxy Watch devices can provide additional data on physiological responses and sleep health. The primary outcome will be the development of machine-learning algorithms to predict depression and anxiety based on these digital biomarkers. We will employ various machine-learning techniques, including random forest, support vector machine and deep-learning models. The secondary outcomes will include the association between digital biomarkers and clinical measures, and the feasibility and acceptability of data collection methods. Various features characterising mobile usage behaviours, physical/social activity, sleep patterns, resting physiological states and circadian rhythms will be exploited to serve as potential digital phenotyping markers. Advanced machine-learning and deep-learning techniques will be applied to multimodal data for model generation.

Ethics and dissemination
This study protocol was reviewed and approved by the Institutional Review Board of the Korea University Anam Hospital (approval number: 2023AN0506). The results of this study will be disseminated via multiple channels. The findings will be presented at local, national and international conferences in relevant fields, such as psychiatry, psychology and digital health. Manuscripts detailing the study results will be submitted to peer-reviewed journals for publication.

Trial registration number
The present study was registered with the Clinical Research Information Service (CRIS, https://cris.nih.go.kr; identifier: KCT0009183).

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