Tuberculosis (TB) remains a significant global health challenge, especially prevalent in the WHO African region. The WHO’s End TB Strategy emphasises effective treatment approaches such as directly observed therapy (DOT), yet the optimal implementation of DOT, whether through health facility-based (HF DOT) or community-based (CB DOT) approaches, remains uncertain.

To conduct a systematic comparison of the effectiveness and cost-effectiveness of Community-Based Directly Observed Treatment (CB DOT) versus Health Facility-Based Directly Observed Treatment (HF DOT) for tuberculosis (TB) treatment in African settings.

We will conduct a systematic review and meta-analysis following Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will search PubMed, Embase, Web of Science, Scopus and the Cochrane Library for articles published up to 30 March 2023, without date restrictions. Eligible studies must be full economic evaluations conducted in African countries, comparing CB DOT to HF DOT regarding treatment outcomes and costs. Exclusion criteria include non-English, non-peer-reviewed or studies lacking caregiver involvement in CB DOT, health facility-based DOT comparison, direct comparability between CB DOT and HF DOT, significant selection bias or non-economic evaluations. Data extraction will be performed independently by reviewers, and meta-analyses will use STATA software. To pool the data, a random-effect model will be applied, and quality assessment of the studies will be conducted.

Ethical approval is not required as the study will use previously published articles available publicly. Findings will be presented at international and national conferences and published in open-access, peer-reviewed journals.

CRD42023443260.

Mental Health Literacy (MHL) is important for improving mental health and reducing inequities in treatment. The Mental Health Literacy Scale (MHLS) is a valid and reliable assessment tool for MHL. This systematic review will examine and compare the measurement properties of the MHLS in different languages, enabling academics, clinicians and policymakers to make informed judgements regarding its use in assessments.

The review will adhere to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology for systematic reviews of patient-reported outcome measures and the Joanna Briggs Institute (JBI) Manual for Evidence Synthesis and will be presented following the Preferred Reporting Items for Systematic reviews and Meta-Analysis 2020 checklist. The review will be conducted in four stages, including an initial search confined to PubMed, a search of electronic scientific databases PsycINFO, CINAHL, Scopus, MEDLINE, Embase (Elsevier), PubMed (NLM) and ERIC, an examination of the reference lists of all papers to locate relevant publications and finally contacting the MHLS original author to identify validation studies that the searches will not retrieve. These phases will assist us in locating studies that evaluate the measurement properties of MHLS across various populations, demographics and contexts. The search will focus on articles published in English between May 2015 and December 2023. The methodological quality of the studies will be evaluated using the COSMIN Risk of Bias checklist, and a comprehensive qualitative and quantitative data synthesis will be performed.

Ethics approval is not required. The publication will be in peer-reviewed journals and presented at national and international conferences.

CRD42023430924.

Children and adolescents with mature B cell non-Hodgkin lymphoma (B-NHL) are treated with short-intensive chemotherapy. The burden of short-term and long-term toxicity is highly relative to its high cure rate in good-risk patients. Although the addition of rituximab to standard lymphome Malin B (LMB) chemotherapy markedly prolongs event-free survival and overall survival in high-risk patients, the benefit of rituximab in good-risk patients remains to be elucidated. This clinical trial will examine whether the addition of rituximab eliminates anthracyclines in good-risk patients without compromising treatment outcomes.

We will perform a single-arm, open-label, multicentre phase II study. Low-risk (stage I – completely resected, stage II abdominal) and intermediate-risk (stages I and II – incompletely resected; stage II – resected, other than abdominal; stage III with LDH x upper limit of normal) patients with newly diagnosed B-NHL are eligible. Low-risk patients receive two courses of R-COM₁P (rituximab, cyclophosphamide, vincristine, methotrexate, prednisolone and intrathecal methotrexate with hydrocortisone), and intermediate-risk patients receive COP (cyclophosphamide, vincristine, prednisolone and intrathecal methotrexate with hydrocortisone) followed by two courses each of R-COM₃P and R-CYM (rituximab, cytarabine, methotrexate and intrathecal methotrexate with hydrocortisone). The primary endpoint is a 3-year event-free survival rate in paediatric patients (

This research was approved by the Certified Review Board at NHO Nagoya Medical Center (Nagoya, Japan) on 21 September 2021. Written informed consent is obtained from all patients and/or their guardians. The results of this study will be disseminated through peer-reviewed publications and conference presentations.

Japan Registry of Clinical Trials, jRCTs041210104.

To identify barriers to hospital participation in controlled cluster trials of clinical decision support (CDS) and potential strategies for addressing barriers.

Qualitative descriptive design comprising semistructured interviews.

Five hospitals in New South Wales and one hospital in Queensland, Australia.

Senior hospital staff, including department directors, chief information officers and those working in health informatics teams.

20 senior hospital staff took part. Barriers to hospital-level recruitment primarily related to perceptions of risk associated with not implementing CDS as a control site. Perceived risks included reductions in patient safety, reputational risk and increased likelihood that benefits would not be achieved following electronic medical record (EMR) implementation without CDS alerts in place. Senior staff recommended clear communication of trial information to all relevant stakeholders as a key strategy for boosting hospital-level participation in trials.

Hospital participation in controlled cluster trials of CDS is hindered by perceptions that adopting an EMR without CDS is risky for both patients and organisations. The improvements in safety expected to follow CDS implementation makes it challenging and counterintuitive for hospitals to implement EMR without incorporating CDS alerts for the purposes of a research trial. To counteract these barriers, clear communication regarding the evidence base and rationale for a controlled trial is needed.

Community-based participatory research (CBPR) is a collaborative research approach that equally engages researchers and community stakeholders throughout all steps of the research process to facilitate social change and increase research relevance. Community advisory boards (CABs) are a CBPR tool in which individuals with lived experience and community organisations are integrated into the research process and ensure the work aligns with community priorities. We seek to (1) explore the best practices for the recruitment and engagement of people with lived experiences on CABs and (2) identify the scope of literature on minimising power dynamics between organisations and community members with lived experience who work on CABs together.

This scoping review will follow the Arksey and O’Malley methodological framework, informed by Levac et al, and will be reported using a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) diagram. Detailed and robust search strategies have been developed for Embase, Medline and PsychINFO. Grey literature references and reference lists of included articles published between 1 January 1990 and 30 March 2023 will be considered. Two reviewers will independently screen references in two successive stages of title/abstract and full-text screening. Conflicts will be decided by consensus or a third reviewer. Thematic analysis will be applied in three phases: open coding, axial coding and abstraction. Extracted data will be recorded and presented in a tabular format and/or graphical summaries, with a descriptive overview discussing how the research findings relate to the research questions. At this time, a preliminary search of peer-reviewed and grey literature has been conducted. Search results for peer-reviewed literature have been uploaded to Covidence for review and appraisal for relevance.

Formal ethics approval is not required for this review. Review findings will inform ongoing and future CBPR community advisory board dynamics.

The protocol has been registered prospectively on the Open Science Framework (https://doi.org/10.17605/OSF.IO/QF5D3)

An increasing number of tracheotomised and/or ventilated patients with high-cost out-of-hospital intensive care needs and, at the same time, a decreasing number of healthcare professionals inevitably lead to challenges in the care of this patient population. In addition, little is known about this population, their health restrictions, needs, patient journeys, care structures and processes. The project ‘Needs, requirements and cross-sectoral care pathways of out-of-hospital ventilated intensive care patients’ (ATME) aims to analyse these aspects and explore current care structures to inform further development of care in line with patients’ needs and requirements.

Qualitative and quantitative methods will be used. In preparation of a semistandardised survey, exploratory interviews will be conducted with tracheotomised and/or ventilated patients with out-of-hospital intensive care needs (TVPOI) (n=15), nursing care providers (n=30), outpatient medical centres, as well as outpatient medical, medical technology and therapeutic care providers (n=35). Three semistandardised survey questionnaires for TVPOI (n=2,000) will be developed and conducted with nursing care facilities (n=250) and outpatient medical centres for mechanical ventilation (n=25). Content analyses will be conducted for qualitative data; survey data will be analysed descriptively. In addition, healthcare claims data will be analysed descriptively to provide information on patient journeys. Three result workshops and one consensus conference will be carried out with representatives of the relevant target groups to analyse the suitability of care structures and to develop recommendations for action to improve TVPOI.

The ATME study received a positive vote from the Ethics Committee of the Osnabrück University of Applied Sciences and is registered in ‘Deutsches Register Klinischer Studien (DRKS)’ (registration number: DRKS00030891). The study results will be presented at national conferences and in relevant peer-reviewed journals. Additionally, study results will be published by the funding institution (the Innovation Committee of the Federal Joint Committee) on their website.

This study aims to investigate the association of ulcerative colitis (UC) with all-cause dementia and assess differences in those with and without a total colectomy.

This Swedish prospective register-based study comprised 4.8 million individuals aged at least 59 years between 1964 and 2018 with the linkage of several Swedish national registers.

Individuals with dementia were defined according to International Classification of Diseases diagnostic codes and Anatomical Therapeutic Classification codes for medication prescriptions. Fitting Cox hazards models, the risk of developing all-cause dementia in individuals with and without UC was estimated. Further, we compared the risk of all-cause dementia among those with and without a colectomy.

Among 4 821 488 individuals (52.6% females) followed for 84.1 million person-years between 1964 and 2018, the incidence rate of all-cause dementia was 63.90 (63.73–64.07) events per 10 000 person-years in individuals without UC, 94.80 (92.04–97.64) among those with UC, 95.01 (92.25–97.86) in those with UC but without colectomy and 63.42 (40.92–98.31) in those with UC and a colectomy. Adjusted Cox models showed an increased all-cause dementia risk in individuals with UC (HR 1.07, 95% CI 1.04 to 1.10). We found no differences between unexposed individuals and those with UC and a colectomy (HR 0.89, 95% CI 0.57 to 1.38).

The findings are consistent with previous evidence suggesting a slightly increased dementia risk among individuals with UC. This study provided no evidence of further risk increase of dementia among those who had a colectomy.

Hormone therapy (HT) is a major adjuvant treatment for breast cancer. Despite their effectiveness, aromatase inhibitors can cause several side effects, including arthralgia in 35%–50% of patients. These side effects frequently lead to the premature discontinuation of HT. Whole-body cryotherapy (WBC) can be used for managing arthritic pain. The primary objective of this study will be to evaluate the effect of WBC on aromatase-induced joint pain, compared with placebo cryotherapy, in patients with hormone-dependent breast cancer receiving adjuvant aromatase inhibitors. The secondary objectives will be to evaluate WBC safety and its effect on analgesic consumption, HT adherence and quality of life.

In this randomised, placebo-controlled, double-blinded clinical trial, 56 patients with aromatase inhibitor-induced joint pain and a Brief Pain Inventory-Short Form (BPI-SF) score ≥3 for the worst pain experienced in the previous week will be randomised into the WBC or placebo cryotherapy arm (10 sessions in each group). The primary outcome will be the BPI-SF score at week 6 post-treatment. The secondary outcomes will include the BPI-SF scores at months 3 and 6 post-treatment, the BPI-SF pain severity index and pain interference index, the Health Assessment Questionnaire score, the number of days of aromatase inhibitor treatment and analgesic consumption in the 15 days before the visits at week 6 and months 3 and 6 after cryotherapy. The incidence of adverse events will also be investigated.

Ethics approval was obtained from the Ethics Committee Est IV of Hospital Civil, Strasbourg, France. Protocol V.5 was approved in December 2022. The results will be disseminated in a peer-reviewed journal and presented at international congresses.

NCT05315011.

We aimed to investigate the regional variations in the number of interventions and surgeries for peripheral artery disease (PAD) and explore the major determinants of the variations.

Cross-sectional study.

The Japanese Ministry of Health, Labour and Welfare National Database and Diagnostic Procedure Combination database in 2018.

The rates of endovascular treatment (EVT), bypass surgery per 100 000 individuals in the population were calculated for all 47 prefectures in Japan. The total annual changes in the rates of EVT and bypass surgery in Japan from 2012 to 2019 were calculated.

A linear regression model was developed with rates of EVT and bypass surgery as dependent variables and regional medical supply in each prefecture as explanatory variables. These regional factors included the rate of percutaneous coronary intervention (PCI) for angina, the numbers of cardiovascular specialists, specialists in cardiac surgery, interventional radiology (IVR) training facilities and cardiovascular surgery training facilities, per 100 000, respectively.

There was a 5.7-fold difference (143 and 25 per 100 000 individuals aged ≥40 years) in the highest and lowest EVT rates. The highest and lowest rates of bypass surgery were 34 and

Considerable regional variations in the rates of revascularisation for PAD were found. Unbalanced presence of medical resources, preference of suppliers and the training system had larger effects on the regional variation in Japan.

Digital health is now routinely being applied in clinical care, and with a variety of clinician-facing systems available, healthcare organisations are increasingly required to make decisions about technology implementation and evaluation. However, few studies have examined how digital health research is prioritised, particularly research focused on clinician-facing decision support systems. This study aimed to identify criteria for prioritising digital health research, examine how these differ from criteria for prioritising traditional health research and determine priority decision support use cases for a collaborative implementation research programme.

Drawing on an interpretive listening model for priority setting and a stakeholder-driven approach, our prioritisation process involved stakeholder identification, eliciting decision support use case priorities from stakeholders, generating initial use case priorities and finalising preferred use cases based on consultations. In this qualitative study, online focus group session(s) were held with stakeholders, audiorecorded, transcribed and analysed thematically.

Fifteen participants attended the online priority setting sessions. Criteria for prioritising digital health research fell into three themes, namely: public health benefit, health system-level factors and research process and feasibility. We identified criteria unique to digital health research as the availability of suitable governance frameworks, candidate technology’s alignment with other technologies in use,and the possibility of data-driven insights from health technology data. The final selected use cases were remote monitoring of patients with pulmonary conditions, sepsis detection and automated breast screening.

The criteria for determining digital health research priority areas are more nuanced than that of traditional health condition focused research and can neither be viewed solely through a clinical lens nor technological lens. As digital health research relies heavily on health technology implementation, digital health prioritisation criteria comprised enablers of successful technology implementation. Our prioritisation process could be applied to other settings and collaborative projects where research institutions partner with healthcare delivery organisations.