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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Prognostic ability of the haemoglobin-to-red blood cell distribution width ratio in predicting in-hospital mortality: a retrospective, longitudinal, observational study among elderly patients with acute ischaemic stroke

Objective
To evaluate the prognostic ability of the haemoglobin-to-red blood cell distribution width ratio in predicting in-hospital mortality among elderly patients diagnosed with acute ischaemic stroke.

Design
Retrospective, longitudinal, observational study using a hospital-based database.

Setting
Claims data from 1 January 2014 until 31 January 2020 were extracted from the database of two hospitals affiliated with Nanjing University.

Participants
Patients aged ≥80 years who were diagnosed with acute ischaemic stroke, excluding those with cancers or other malignant diseases.

Outcome measures
Patients were stratified into three groups based on the tertiles of the haemoglobin-to-red blood cell distribution width ratio. The dose-dependent relationship between this ratio and in-hospital mortality risk was determined with robust locally weighted regression analyses and restrictive cubic spline on continuous variables. The primary endpoint was defined as all-cause mortality during the hospital stay, and the secondary endpoint centred on the duration of the hospital stay.

Results
A total of 606 patients constituted the dataset for the conclusive analysis (mean age, 84.6 ± 3.2 years; female, 40.3%). The haemoglobin-to-red blood cell distribution width ratio was categorised into three tertiles (T1, 8.34). After adjusting for relevant demographic and clinical variables, a statistically significant inverse correlation was observed between higher ratios and lower risk of in-hospital mortality, with HRs of 0.48 (95% CI, 0.34 to 0.68) for T2:T1 and 0.14 (95% CI, 0.08 to 0.23) for T3:T1. A dose-dependent relationship was evident between the haemoglobin-to-red blood cell distribution width ratio and in-hospital mortality risk. The sensitivity analysis indicated that no attenuation was observed in the HR in both non-anaemic and anaemic cases. The results also indicated that a shorter length of hospital stay was associated with a higher haemoglobin-to-red blood cell distribution width ratio.

Conclusions
A high haemoglobin-to-red blood cell distribution ratio may be an independent protective factor for in-hospital mortality and reduced length of stay in elderly patients suffering from acute ischaemic stroke.

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Economic evaluation of a lifestyle intervention for individuals with overweight or obesity suffering from chronic low back pain (the BO2WL trial): a protocol for a health economic analysis

Introduction
Low back pain (LBP) is highly prevalent across the Western world, including Switzerland (CH) and Belgium (BE), with women experiencing higher disability rates than men. Chronic LBP (CLBP), persisting beyond 3 months, leads to diminished health-related quality of life and increased healthcare and societal costs. Evidence indicates a direct relationship between body mass index (BMI) and CLBP severity, with high BMI significantly driving LBP-related healthcare expenses. Current evidence supports combining pain neuroscience education (PNE) with cognition-targeted exercise therapy (CTET) to effectively manage CLBP.
An economic evaluation alongside a randomised controlled trial, entitled ‘Lifestyle Intervention in Overweight/Obese CLBP Patients: an International Multi-centre RCT’ (BO2WL), will be conducted in CH and BE. It aims to evaluate the addition of a lifestyle intervention to PNE and CTET compared with PNE and CTET alone for treating individuals with CLBP and overweight or obesity. This protocol outlines the details of the economic evaluation of this trial.

Methods and analysis
The trial consists of a 14-week intervention followed by a 52-week post-intervention follow-up. Primary outcomes include direct and indirect costs, as well as quality-adjusted life years and pain intensity. Cost data will be converted into 2026 Belgium (BE) and 2026 Swiss Francs (CHF) for CH, with a discount rate of 3.5%. Incremental cost-utility and cost-effectiveness ratios will be calculated from a societal perspective for each country.

Ethics and dissemination
Ethics approval was obtained by the local ethics committees (Bern, CH: project ID 2022–02210; Brussels and Geel, BE: BUN 1432022000296). Results of the main trial and economic evaluation will be submitted for publication in a peer-reviewed journal.

Trial registration number
NCT05811624.

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Medicines support and social prescribing to address patient priorities in multimorbidity (MIDAS): protocol for a definitive, multi-arm, cluster randomised, controlled trial in Irish general practice

Background
There is increasing awareness of the impact of living with multiple long-term conditions (referred to as multimorbidity) on patients and health systems. Managing multimorbidity remains a challenge for primary care providers; necessitating tailored interventions that are both clinically and cost effective. In the Irish health system, two pilot trials have demonstrated promising results for patients living with multimorbidity. The first, MultimorbiditY COllaborative Medication Review And DEcision making (MyComrade), involved pharmacists supporting the management of polypharmacy, and the second, Link MultiMorbidity (LinkMM), involved link workers delivering social prescribing. This definitive trial aims to evaluate the clinical and cost effectiveness of both these interventions, as well as conduct a process evaluation.

Methods
This is a pragmatic, multi-arm, definitive, cluster randomised controlled trial in Irish general practices. The trial will include three arms: (1) MyComrade; (2) LinkMM and (3) usual care, acting as an efficient shared control arm for both interventions. For this trial, 672 patients will be recruited from 48 general practices. The eligibility criteria for the patients will be: (1) over 18 years of age; (2) has two or more chronic conditions; (3) taking 10 or more regular medicines and (4) attending their general practice team for chronic disease management. Outcome data will be collected for all participants, across all trial arms at baseline and 6 months. Primary outcomes include the number of medicines (reflecting the MyComrade intervention) and patient capability (reflecting the LinkMM intervention). Secondary outcomes include proportions and types of potentially inappropriate medications, patient experience of care, patient activation, self-rated health, health-related quality of life, mortality and healthcare utilisation. Quantitative and qualitative data will be collected to inform the process evaluation. Additionally, an economic evaluation will be conducted to evaluate the cost-effectiveness of both interventions compared with the control arm.

Ethics and dissemination
The trial protocol was approved by the Irish College of General Practice (ICGP) Ethical Review Board (ref: ICGP_Rec_2023_016). A formal knowledge dissemination plan has been developed for the trial, which includes peer-reviewed publications, conference presentations and reports to healthcare professionals, commissioners and policymakers.

Trial registration number
ISRCTN11585238.

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What is the added value of handsearching Hungarian medical journals and grey literature for identifying controlled clinical trials? Protocol for a meta-epidemiological study

Introduction
Randomised controlled trials (RCTs) are considered the gold standard for evaluating the efficacy and safety of healthcare interventions. For valid systematic reviews and evidence-based clinical guidelines, it is essential that results of all eligible RCTs are accessible. However, articles about trials published in languages other than English are often not listed in well-known and open trial databases like Medline and therefore scarcely findable. Handsearching national journals is an important approach to identify these articles and enhance their global visibility. Consequently, the results of trials conducted and published in non-English-speaking countries are not lost but rather integrated into the global body of evidence.
The present study aims to evaluate the benefits of extensive handsearching in Hungary and to identify key medical fields for future efforts. We will also assess the extent of grey literature in Hungary. We will appraise the risk of bias in the identified RCTs and controlled clinical trials (CCTs; indicating quasi-randomised or possibly randomised controlled trials) and examine the reporting quality of articles in Hungarian medical journals. Additionally, we will explore whether the automation tool Paperfetcher, recommended by Cochrane for handsearching, can effectively support these efforts in a non-English language context.

Methods and analysis
We will conduct a cover-to-cover handsearch of all Hungarian medical journals publishing content in the year 2023 to identify all controlled clinical trials, including RCTs, CCTs and non-RCTs, which are trials that use a clearly non-random method for allocating participants to groups. We will also search conference proceedings submitted to the Hungarian National Széchényi Library, abstract supplements from journals available via the Hungarian Medical Bibliography database, preprints available on medRxiv, Hungarian theses and dissertations, as well as Google Scholar to identify grey literature.
Two independent researchers will screen the identified records, assess their eligibility, extract data and evaluate the risk of bias and reporting quality according to the CONSORT statement. To verify the availability of reports and publications derived from the identified trials in electronic databases, we will systematically search MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), Embase and Scopus. All identified RCTs and CCTs not yet included in CENTRAL will be added to the database. Additionally, we will compare handsearching supported by the Paperfetcher tool with unsupported handsearching to evaluate the tool’s effectiveness in a Hungarian language context.

Ethics and dissemination
Since the publication resulting from the handsearching activity is a retrospective review of publicly available sources of evidence, ethical approval is not required. The study findings will be submitted for publication in a peer-reviewed journal and will be presented at international conferences.

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Factors influencing career plateau in nurses: a protocol for systematic review and meta-analysis

Introduction
Career plateau is a situation that has many negative effects on individual nurses, nursing management and nursing profession. Despite global research examining career plateaus among nurses, a comprehensive data synthesis on its prevalence and influential factors is still missing. The study aims to systematically analyse the prevalence of career plateau in nurses and explore the related influencing factors.

Methods and analysis
The anticipated start date for the study is December 2025, and the anticipated end date is August 2027. We will search PubMed, Web of Science, Embase, PsycINFO, CINAHL, Scopus, the China National Knowledge Infrastructure, the Wanfang database and the China Biomedical Literature Database (SinoMed) from the establishment of the database to the present for studies on the prevalence and influencing factors of career plateau in nurses. Two researchers will independently conduct literature screening and data extraction. They will evaluate the quality of the included studies using the Joanna Briggs Institute critical appraisal tool and the mixed-methods appraisal tool. If possible, we will conduct a meta-analysis, which is according to the data heterogeneity. If the heterogeneity is too large to be resolved, we will present them narratively and descriptively according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria, summarise status and influencing factors of the career plateau in nurses.

Ethics and dissemination
No formal ethics approval is required for this protocol and no primary data will be collected. The results will be disseminated through peer-reviewed journals and presented at conferences.

PROSPERO registration number
CRD42024545439.

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Barriers and facilitators to offering palliative care to patients with heart failure: a mixed-methods systematic review using the COM-B model and theoretical domains framework

Objectives
Despite palliative care (PC) potentially improving quality of life, only a tiny proportion of patients with heart failure (HF) are receiving PC. Globally, PC for HF patients faces several challenges; however, a systematic assessment of the barriers and facilitators to PC of patients suffering from HF is lacking. We aimed to identify barriers and facilitators to offering PC to HF patients.

Design
The mixed-methods systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement.

Data sources
PubMed, CINAHL, MEDLINE, PsycINFO, Web of Science were searched from onset of literature database to 24 March 2025.

Eligibility criteria
We included both qualitative studies and quantitative studies addressing barriers and facilitators to offering PC to patients with HF reported by healthcare providers, patients, family members and caregivers.

Data extraction and synthesis
Data extraction was done independently by two reviewers, and quality assessment was completed using the mixed-methods appraisal tool. The Capabilities-Opportunities-Motivations-Behaviour (COM-B) model and the Theoretical Domain Framework (TDF) were used to identify potential barriers and facilitators.

Results
48 studies were included out of 4168. 289 items related to barriers and 88 items related to facilitators were categorised into 72 themes. These themes were found to align with at least one of the 14 TDF domains and the COM-B model. ‘Environmental context and resources’ (eg, lack of time, human, facilities and equipment resources; 77.2% of barriers vs 22.8% of facilitators), ‘knowledge’ (eg, insufficient awareness and knowledge of PC and/or needs; 91.8% of barriers vs 8.2% of facilitators) and “‘social influences’ (eg, limited communication and collaboration between healthcare professionals; 58.7% of barriers vs 41.3% of facilitators) were the three TDF domains that encoded the largest amount of data.

Conclusions
This review identified key barriers to PC for HF patients, primarily involving resource limitations, knowledge gaps and poor interdisciplinary collaboration. Findings highlight the need for targeted interventions addressing systemic and knowledge-related challenges.

PROSPERO registration number
CRD42023484807.

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