Digital health interventions (DHIs) show considerable promise in supporting hypertension self-management by promoting preventative care and self-monitoring. While their efficacy is increasingly evident, the long-term uptake, acceptance and sustained engagement with these tools are frequently challenged by issues such as usability, trust and varying user experiences. This review aims to synthesise qualitative evidence to identify barriers and facilitators and the key factors that impact the adoption, acceptance and engagement with DHIs for hypertension self-management.

Systematic review of qualitative literature using thematic analysis following Cochrane’s qualitative and implementation methods guidance.

PubMed, PsycInfo, Web of Science and the Cochrane Library were searched in February 2025.

The searches included relevant qualitative and mixed-methods studies on the use of digital devices for hypertension management, which described the barriers and facilitators associated with these tools. We included studies published from 2015 to 2025 to capture relevant evidence. Only studies published in English with a qualitative approach were included.

From an initial 10 943 identified publications, 15 met our inclusion criteria, primarily originating from Europe and the USA, exploring diverse racial and ethnic group experiences. Our thematic synthesis revealed 7 analytical and 22 descriptive themes detailing barriers and facilitators encountered by patients with hypertension, healthcare providers (HCPs) and caregivers. These themes covered technology utilisation, design components, linguistic and cultural relevance, healthcare factors, trust and credibility and interpersonal interactions.

Our analysis underscores that factors such as the usability, design and relevance of social support profoundly influence the uptake and acceptance of DHIs in hypertension self-management among patients, caregivers and HCPs.

CRD42023480389.

Although several systematic reviews and meta-analyses have demonstrated the benefits of exercise interventions in older adults with frailty, the potential harm associated with these interventions has not been systematically synthesised. This systematic review aims to examine the adverse events reported in exercise intervention trials involving older adults with frailty and to compare the risk of adverse events between the intervention and control groups.

Searches will be performed in four electronic databases (PubMed, Cochrane Library, Web of Science and SPORTDiscus) for published trials. Eligible studies will be randomised controlled trials of exercise interventions, including older adults with frailty aged ≥60 years, with frailty identified using a validated method. Five reviewers and three referees, all with expertise in exercise interventions, will be assigned to three independent review teams to ensure efficient screening. Reviewers will independently screen titles, abstracts and full texts using Rayyan, and then extract trial and adverse event data into an Excel spreadsheet. The risk of bias in eligible trials will be assessed using the Cochrane Risk of Bias 2 (RoB-2) tool. The referees will resolve any disagreements between the two reviewers throughout the screening, data extraction and risk-of-bias assessment processes. The primary outcome is adverse events, defined as any unfavourable, unintended signs, symptoms or disease that occurred during the study period. An independent biostatistician will perform a random-effects meta-analysis using a generalised linear mixed model with a binomial likelihood and a logit link to estimate the pooled risk ratios (RRs) for adverse events in the intervention group relative to the control group. Publication bias will be evaluated using funnel plots and Egger’s regression test. Depending on the number of available studies, subgroup analyses will be conducted to examine differences in RRs according to the study quality, duration of intervention, exercise frequency, setting and supervision.

Ethical approval was not required because we did not use specific patient data. The findings of the systematic review and meta-analysis will be disseminated through publication in a peer-reviewed journal and presentation at appropriate conferences.

CRD420251180645.

To examine whether the use of a venous access-site closure device is associated with the occurrence of postoperative nausea and vomiting (PONV) after atrial fibrillation (AF) ablation under propofol sedation.

Observational study.

A single-centre retrospective observational study in Okayama, Japan.

We retrospectively analysed consecutive patients who underwent AF ablation under deep propofol sedation with adaptive servo-ventilation. A total of 686 patients were included. Patients were managed using a standardised sedation protocol with or without low-dose pentazocine. Patients treated with conventional manual compression for haemostasis (n=383) were compared with those treated using a venous access-site closure device (n=303).

Postprocedural bed rest duration and the incidence and timing of PONV were compared between groups. Associations between closure device use and PONV were evaluated using logistic regression analysis.

The primary outcome was the occurrence of PONV following AF ablation.

All procedures were completed under propofol sedation without conversion to general anaesthesia. The duration of postprocedural bed rest was shorter in the device group than in the conventional-compression group (mean difference –14.7 hours, 95% CI –15.2 to –14.0).

PONV occurred in 6/303 patients (2.0%) in the device group and 20/383 patients (5.2%) in the conventional-compression group, corresponding to a relative risk of 0.38 (95% CI 0.15 to 0.93), an OR 0.25 (95% CI 0.10 to 0.62) and a risk difference of –3.2% (95% CI –6.0% to –0.5%).

In multivariable analysis, use of a venous closure device was associated with a lower likelihood of PONV.

In this single-centre observational study, use of a venous access-site closure device was associated with a lower occurrence of PONV after AF ablation under propofol sedation. These findings suggest that postprocedural management strategies enabling earlier mobilisation may be associated with improved patient comfort; however, causal inference is limited by the observational design.

The establishment of an effective strategy for recurrence prevention following curative treatment for hepatocellular carcinoma (HCC), including radiotherapy, remains a critical unmet clinical need. Despite favourable local control and safety profiles, recurrence after particle therapy remains a major challenge, highlighting the need for effective adjuvant strategies to improve long-term outcomes. The present phase Ib/II trial is designed to evaluate the safety and efficacy of atezolizumab plus bevacizumab (Atezo+Bev) administered after carbon-ion radiotherapy (C-ion RT) in patients with unresectable non-metastatic large HCC. This study aims to explore the potential of this multimodal approach as a novel adjuvant strategy to improve outcomes in patients at high risk of recurrence.

This is a phase Ib/II, single-arm clinical trial designed to evaluate the safety and efficacy of adjuvant Atezo+Bev following C-ion RT in patients with HCC. Eligible patients will be enrolled in the first registration phase. C-ion RT (60 Gy) will be administered over four consecutive treatment days ideally within one calendar week. Patients will receive a combination of atezolizumab (1200 mg) and bevacizumab (15 mg/kg) administered intravenously every 21 days for one treatment cycle. The primary endpoint of the phase Ib part is the proportion of patients with dose-limiting toxicity (DLT). DLT is defined as prespecified toxicities associated with the investigational drug among the adverse events that occurred from the start date of the investigational drug (Day 1) to Day 21. If there is one or fewer cases of DLT out of six cases, the trial will proceed to the phase II part. The primary endpoint of the phase II part is the 1-year recurrence-free survival rate.

This study was approved by the ethics committee of two participating institutions (Chiba University Hospital (approval No. 2024021) and National Institute for Quantum and Radiological Science and Technology, QST Hospital (approval No. C24-001)). Trial results will be reported in a peer-reviewed journal publication.

jRCT2031240284.

Fibromyalgia is a polysymptomatic central sensitisation disorder characterised by widespread pain, fatigue, sleep disturbances and neuropsychiatric features. Hyperbaric oxygen therapy modulates neuroinflammation, mitochondrial function and neuroplasticity, thereby yielding analgesic and functional benefits.

Evaluate the efficacy and optimal timing of hyperbaric oxygen therapy as an adjunct to standard care for fibromyalgia.

This single-centre, randomised, cross-over group, assessor-blinded clinical trial was conducted in the Department of Rheumatology at the University Hospital of the Federal University of Juiz de Fora, Juiz de Fora, Brazil, and adhered to Consolidated Standards of Reporting Trials (CONSORT) guidelines. Women (18–70 years) with a diagnosis of fibromyalgia for ≥2 years were randomised 1:1 to early hyperbaric oxygen therapy plus standard care or standard care alone (delayed group). Intention-to-treat (ITT) analysis was conducted with all 56 participants (mean age: 51.0±9.8 years; mean body mass index: 30.5±5.1 kg/m²).

Standardised care (education, exercise and pharmacotherapy) plus hyperbaric oxygen therapy was delivered at 2.3 atmospheres absolute for 90 min, five times per week, over 8 weeks (total 32–40 sessions). The early group received hyperbaric oxygen therapy during weeks 0–8, while the delayed group received it during weeks 8–16, following the same protocol.

Primary endpoints included the Fibromyalgia Impact Questionnaire-Brazilian Portuguese (FIQR-Br), the pain visual analogue scale (VAS) and the Symptoms Assessment Scale-40 (EAS-40) for psychopathology. Secondary endpoints included the 12-Item Short-Form Health Survey (SF-12) physical and mental components and adverse effects. Assessments were conducted at baseline, 8 weeks and 16 weeks, and analysed using a mixed-design 2x3 analysis of variance (group: early vs delayed; time: baseline, 8 weeks and 16 weeks) with Greenhouse-Geisser corrections as needed, followed by Bonferroni post hoc tests. Missing data were assessed using Little’s missing completely at random (MCAR), and considering the ITT analysis, the means imputed for missing data were estimated through expectation maximisation. Effect sizes were reported as partial ² and Cohen’s d with α=0.05.

44 participants completed the study, and the overall withdrawal rate was 21.4% with no baseline between-group differences. Significant time effects were observed for all primary outcomes and the SF-12 outcome (pxtime interactions were significant for FIQR-Br, VAS, EAS-40 and SF-12 physical and mental (p≤0.02; interaction ² up to 0.23), indicating improvements during active hyperbaric oxygen therapy exposure. Compared with standard care alone over 8 weeks, combined treatment achieved greater gains: FIQR-Br, –31.1% vs –14.4%; VAS, –54.0% vs –33.5%; EAS-40, –28.4% vs –3.7%; SF-12 physical, +39.1% vs +14.8%; SF-12 mental, +57.4% vs +31.9%. Large within-group effect sizes were observed (eg, VAS d=2.5–2.7; FIQR-Br d=1.4–1.7). Efficacy was equivalent regardless of time started, and the benefits converged by the end of each hyperbaric oxygen therapy phase. After stopping hyperbaric oxygen therapy, the FIQR-Br and SF-12 mental component scores regressed towards standard care levels, whereas residual improvements persisted for up to 8 weeks in VAS, EAS-40 and SF-12 physical component scores. Adverse events were infrequent; one case of otalgia required extended management. Withdrawals were primarily due to non-compliance or intolerance to chamber confinement. No serious or unexpected safety concerns were reported.

Hyperbaric oxygen therapy, delivered under a standardised protocol, is an effective and well-tolerated adjunct to multimodal fibromyalgia care. Timing can be individualised: early initiation for rapid relief or stepped introduction after optimised usual care, with comparable overall efficacy. The durability of the benefit appears to be exposure dependent, and maintenance or booster schedules merit further evaluation.

RBR-6prps8g.

To develop a simple screening scale to predict depression after discharge in patients with acute coronary syndrome after percutaneous coronary intervention (ACS-PCI) and to verify its reliability, validity and cutoff value.

Prospective longitudinal study was conducted 1 week and 3 months after discharge.

Two hospitals where PCI is performed in Japan.

A total of 183 patients were potential candidates for the survey, of whom 42 provided valid responses (response rate: 23.0%).

The number of items was reduced from 14 to 12 with item-total correlations and principal component analysis. Cronbach’s alpha coefficient was 0.832 and the intraclass correlation coefficient (1, 2) was 0.811 (95% CI 0.650 to 0.898). Significant correlations were observed for concurrent validity (r=0.699, p

This study developed a simple screening scale for predicting postdischarge depression in patients with ACS-PCI (SDACS-12) and demonstrated its reliability, validity and predictive ability with 12 items. Nevertheless, its results should be interpreted cautiously given the moderate variance explained by PCA and the low specificity and PPV.

In sub-Saharan African countries, the population-based assisted vaginal birth (AVB) rate is approximately 1% as compared with 16% in Western Europe. Consequently, women experiencing prolonged labour often face limited access to prompt intervention, leading to maternal and perinatal complications or unnecessary caesarean sections (CS). The OdonAssist device has been developed to be safe, user-friendly and more acceptable than currently used AVB devices. We propose to conduct a study in Ethiopia to evaluate if the implementation of this innovation is feasible and may contribute to improving the access to AVB while reducing unnecessary CSs.

We designed a single-centre feasibility study at Saint Luke Catholic Hospital (Wolisso, Ethiopia), a secondary facility where AVB is routinely performed by midwives and health officers under gynaecologist supervision, reflecting the local health system. Following a quasi-experimental design, we will include three groups of 20 women: an intervention group (OdonAssist), a vacuum extraction cohort and a control group of second-stage CS (performed without a prior trial of instrumental birth). The primary objective is to assess the clinical and methodological feasibility of the OdonAssist by collecting preliminary data on safety, acceptability and quantifying potential efficacy relative to the current standard of care. An exploratory economic evaluation of direct healthcare costs will be performed.

Approved by the Oromia Regional Health Bureau. The study results will be published in peer-reviewed journals to inform future impact evaluations of the OdonAssist device in global maternal and perinatal health.

NCT06918509.

Type 2 diabetes (T2D) presents a global healthcare burden. Despite widespread use of non-insulin glucose lowering therapies, many individuals still require insulin to achieve recommended target glycated haemoglobin (HbA1c). Insulin injections improve HbA1c but can lead to problematic hypoglycaemia. The objective of this study is to determine whether fully closed-loop insulin delivery improves HbA1c at 26 weeks compared with standard insulin therapy with continuous glucose monitoring (CGM) in adults with T2D.

This study adopts an open-label, multinational, randomised, single-period parallel design and aims to randomise 224 adults with T2D to either standard insulin therapy with CGM (control group) or fully closed-loop insulin delivery (intervention group) for a period of 26 weeks. Participants will complete a run-in period of 2–3 weeks wearing a masked CGM followed by randomisation to either the control or intervention group. The primary endpoint is the between-group difference in HbA1c at 26 weeks. Key endpoints include time in target glucose range (3.9–10.0 mmol/L), mean sensor glucose, time above range (>10.0 mmol/L) and non-inferiority for time below target (

The study has received ethical approval from the East of England Cambridgeshire and Hertfordshire Research Ethics Committee (24/EE/0149) in the UK. Ethical approval for non-UK site has been obtained by local Research Ethics Committees.

Results will be disseminated by peer-reviewed publications and conference presentations, and findings will be shared with people living with diabetes, healthcare providers and relevant stakeholders.

NCT06579404.

Heart failure occasionally develops after transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS), despite procedural success. Most cases present with mildly reduced or preserved left ventricular ejection fraction (LVEF), underscoring the role of diastolic dysfunction. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have shown benefits across the heart failure spectrum, independent of LVEF. The purpose of this randomised controlled trial is to determine whether adding a SGLT2 inhibitor to conventional medications improves LV diastolic function in patients with preserved LVEF after TAVI.

This study is a prospective, single-centre, open-label, randomised, parallel-group, two-arm trial enrolling patients with mildly reduced or preserved LVEF (≥40%) undergoing TAVI for severe AS. Participants will be randomised in a 1:1 ratio to receive either conventional medications plus empagliflozin or conventional medications alone. In the empagliflozin group, participants will receive conventional medical therapy plus empagliflozin 10 mg orally once daily, initiated 4 weeks after TAVI. Empagliflozin treatment will continue throughout the study period. Participants in the control group will receive conventional medications without empagliflozin. The primary endpoint is the change in E/e’, assessed by echocardiography from treatment initiation at 4 weeks post TAVI (day 1) to day 168 (week 24). Each group will include 50 patients, totalling 100 patients.

Ethical approval for this study has been obtained from the Chiba University Hospital Certified Clinical Research Review Board (CRB0111-25).

jRCT1031250190.

Chronic central serous chorioretinopathy (CSC) can cause progressive and permanent vision loss. Although photodynamic therapy (PDT) is a primary treatment option globally, it is not approved for CSC worldwide, limiting therapeutic access. The REPLAY trial is a phase III, investigator-initiated trial to evaluate the efficacy and safety of reduced-fluence PDT (rf-PDT) for chronic CSC to seek the first regulatory approval globally.

This study comprises two cohorts. The ‘untreated cohort’ is a multicentre, randomised, placebo-controlled, double-masked trial involving 60 patients with untreated, fovea-involving chronic CSC, randomised 2:1 to receive a single rf-PDT or placebo treatment. The ‘previously treated cohort’ is a single-arm, open-label trial for up to 10 patients with recurrent CSC after PDT. The primary endpoint for both cohorts is the proportion of eyes with a complete resolution of subfoveal fluid at 12 weeks post-treatment, assessed by optical coherence tomography. Secondary endpoints include changes in best-corrected visual acuity, central choroidal thickness, recurrence rates and incidence of adverse events over a 48 week follow-up.

The study protocol was approved by the Kyoto University Hospital Institutional Review Board, IRB of Chiba University Hospital, Tokyo Women’s Medical University Institutional Review Board and Institutional Review Board of Kansai Medical University Hospital. Written informed consent is obtained from all participants. The results will be disseminated through publication in a peer-reviewed journal and presentations at scientific conferences.

jRCT2051230156 (URL: https://jrct.mhlw.go.jp/latest-detail/jRCT2051230156).

In the USA, an estimated 40–50 million operations are performed annually, with high rates of adverse events. Since the 1980s, report cards have been used for outcome measures and to improve safety of surgical care. As part of Making Healthcare Safer IV—an initiative aimed at publishing evidence-based reviews as they are completed to help healthcare leaders, researchers and policymakers act more quickly on evidence-supported practices—we performed an updated review on the certainty of evidence on patient safety practices related to the use of surgical report cards and outcome measurements.

Systematic review using the Grade of Recommendations Assessment, Development and Evaluation (GRADE) approach.

PubMed, Web of Science, Scopus and the Cochrane Library were searched from November 2011 to May 2023.

We included primary research studies (randomised control trials or observational studies with a comparison group, including pre–post studies) or observational studies that investigated a surgical report card in adult or paediatric surgical patients at the hospital or surgeon level in inpatient or outpatient settings. Excluded studies included: narrative reviews, scoping reviews, editorials, commentaries, abstracts, studies that measured only patient knowledge or levels of engagement or studies using local surgical dashboard data.

Screening and eligibility were done in duplicate, while data extraction was done by one reviewer and checked by a second reviewer. Specific items in the Risk Of Bias In Non-randomised Studies - of Interventions tool and a modification of the National Institutes of Health Tool were used to assess for bias in studies. Two reviewers assessed each study for risk of bias. A modified version of the GRADE framework was used to assess the certainty of evidence.

We identified 19 studies that met the inclusion criteria: 13 primary research studies and 6 descriptive studies of surgical collaboratives. Of the primary studies, nine used a pre–post or longitudinal study design and four used a regression discontinuity or concurrent controlled design. Seven of the studies were about the American College of Surgeons National Surgical Quality Improvement Project. Five studies were from single institutions and the remainder included nine to greater than 700 hospitals. Pre–post studies of report cards that prompted quality improvement (QI) programmes all reported improvements in outcomes, longitudinal studies reported benefits in some but not all outcomes and one in four controlled before-and-after studies reported a statistically significant mortality benefit. All studies, except for one, were at moderate or high risk of bias. Six collaboratives were identified with preliminary data.

Based on the above evidence, the theoretical rationale and parallel evidence in other settings, we judged that it was moderate certainty that report cards and outcomes measurements can improve surgical outcomes. However, given the evidence from studies where report cards were actively linked to institutional QI initiatives, we recommend that outcome data must be paired with actionable QI efforts to meaningfully improve patient outcomes.

To examine trends and demographic characteristics of syphilis incidence in Japan using a large nationwide claims database with family linkage, with particular focus on differences by sex, age, HIV status and family relationships.

Retrospective cohort study.

JMDC claims database (JMDC Inc, Tokyo, Japan), a nationwide administrative claims database in Japan, using data from 2016 to 2023.

Individuals aged 16–59 years enrolled in the JMDC database, including employees of medium-to-large companies and their dependents (n=12.5 million).

Syphilis cases were defined by International Classification of Diseases, 10th Revision (ICD-10) codes (A50–A53) with concurrent treatment with relevant antibiotics. We determined syphilis incidence rates per 100 000 person-years, stratified by sex, age, HIV status and family relationships. We also investigated within-couple concordance patterns and reinfection rates.

Among 16.4 million individuals, 9357 syphilis infections were identified among 8881 individuals. Incidence increased markedly during the pandemic, reaching 48.2 (men) and 12.9 (women) per 100 000 person-years in 2023. Men showed consistently high incidence in their 20s–50s, whereas female incidence peaked in the 10s–20s. Among 2 294 184 married couples, dependent women (ie, housewives) showed comparably high incidence to age-matched men (10–20 per 100 000 person-years). In 1286 couples with at least one syphilis case, 12.4% of wives in their 20s were also diagnosed, compared with 2%–3% in older groups. In 20s couples, the proportion of syphilis among wives only and husbands only was similar. Subgroup analysis revealed notably high incidence among unmarried female dependent youths (2022: 66.7 per 100 000 person-years). Individuals living with HIV had substantially elevated incidence (3000–15 000 per 100 000 person-years) and reinfection rates.

Using a large claims database with family linkage, we found that while male syphilis incidence remained dominant, high rates were also observed among dependent women and youths. These findings suggest that syphilis risk may extend beyond traditionally recognised high-risk populations and emphasise the need for targeted screening and preventive strategies in broader demographic groups.

Diabetes is a chronic disease characterised by elevated blood sugar levels, which can lead to damage across various body systems. Bangladesh has the second highest number of adults with diabetes in South Asia and faces a significant economic burden from this condition. The objective of this study was to investigate the economic burden of diabetes and its associated factors among patients with diabetes registered at a tertiary-level diabetes hospital in the Rajshahi region of Bangladesh.

This was a cross-sectional hospital-based study.

Primary data were collected from patients with diabetes at a tertiary-level diabetes hospital in Bangladesh.

The study recruited 400 patientswith diabetes, who were randomly selected. The economic burden was assessed using the Catastrophic Health Expenditure (CHE) threshold of ≥10% of household income. Descriptive statistics, 2 tests, t-tests, linear regression and binary logistic regression were employed for analysis, with statistical significance set at p

The proportion of diabetes-related burden among patients with diabetes was 50.7%. 95.8% of patients had type 2 diabetes, and over half (52.5%) were overweight or obese. Treatment costs were significantly associated with diabetes duration, insulin use and age (35–55 vs ≥56 years). The economic burden was strongly associated with lower income levels (poor income and middle income vs high income) and longer diabetes duration. Participants not adhering to a healthy diet had 43% lower odds of experiencing economic burden than those following a healthy diet.

Approximately half of the patients experienced catastrophic health expenditure due to diabetes, indicating a substantial economic burden in the Rajshahi region of Bangladesh. This burden was significantly higher among lower-income and middle-income groups and patients with longer disease duration, and treatment-related factors such as insulin use were associated with greater financial strain. These findings emphasise the need for targeted financial protection strategies, including subsidised care and preventive interventions.