To summarise the evidence on long-term and infrequent harms following selected spinal and paraspinal injections and denervation procedures for chronic non-cancer spine pain.

Systematic review and meta-analysis.

MEDLINE, EMBASE and Cumulative Index to Nursing and Allied Health Literature from inception to October 2023.

Non-randomised studies reporting on harms of selected interventional procedures administered to adults living with chronic axial or radicular non-cancer spine pain with ≥4 weeks of follow-up.

A parallel guideline panel provided input on the scope, design and interpretation of this systematic review, including selection of adverse events for consideration. Systematic literature screening, data abstraction and risk of bias appraisal were conducted independently and in duplicate by pairs of reviewers. We used random-effects models for all meta-analyses and the Grading of Recommendations Assessment, Development and Evaluation approach to evaluate the certainty of evidence.

We included 60 longitudinal studies (56 non-comparative, 4 comparative) that enrolled 4966 patients with chronic non-cancer spine-related pain. 31 studies investigated radiofrequency ablation or denervation, 22 epidural injections and 11 joint injections or nerve blocks. Low certainty evidence suggests that joint targeted steroid injection and epidural steroid injection for chronic spine pain may result in temporary altered level of consciousness (incidence: 2.1%; 95% CI 1.1% to 4.0%), joint radiofrequency nerve ablation, joint targeted steroid injection and epidural injection of local anaesthetic and steroids may result in deep infection (incidence: 0.7%; 95% CI 0.3% to 2.0%), epidural steroid injection, joint radiofrequency nerve ablation and joint targeted injection of local anaesthetic and steroids may result in dural puncture (incidence: 1.4%; 95% CI 0.5% to 4.3%), and dorsal root ganglion radiofrequency and joint radiofrequency nerve ablation with or without joint-targeted injection of steroids may result in prolonged pain or stiffness (incidence: 8.6%; 95% CI 6.3% to 11.6%). Several interventional procedures may result in metabolic complications and prolonged sensory deficits, but the supporting evidence was only very low certainty. Most complications resolved spontaneously or with conservative management.

Low certainty evidence suggests that several common interventional procedures for chronic spine pain show risk of deep infection, dural puncture, temporary altered level of consciousness and prolonged pain or stiffness. Other harms are uncertain due to very low certainty evidence, and catastrophic outcomes were not reported in the small studies that contributed to our analyses.

The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) was the first to show that multidomain lifestyle interventions can enhance brain health and reduce cognitive decline. However, the clinical effectiveness and delivery of the FINGER model within primary care settings remain unexplored. This paper presents the protocol for the STRONGER 60+trial, which aims to evaluate both the clinical effectiveness and real-world delivery of an adapted FINGER-based intervention in primary care.

This 6-month randomised controlled clinical effectiveness trial will be conducted in primary care and will include adults aged 60 and older with vascular or lifestyle-related risk factors for dementia. A total of 80 participants will be randomised to either a structured, supervised multidomain lifestyle intervention or a self-guided version of the same programme. The intervention includes nutritional guidance, physical exercise, cognitive training, social engagement and management of vascular and metabolic risk factors. Data will be collected at baseline, 6 months (primary endpoint) and 12 months post-randomisation. The primary outcome is the change in a composite healthy lifestyle score at 6 months. In addition, the study will explore delivery processes and stakeholder (participant and healthcare professional) perspectives using both qualitative and quantitative methods.

The study has been approved by the Swedish Ethical Review Authority (approval numbers: 2020–05785, 2021–06413-02, 2022–05454-02) and will follow the principles of the Declaration of Helsinki. Ethical procedures for informed consent, confidentiality and data management will be strictly observed. Results will be disseminated through scientific publications, conferences and targeted outreach to healthcare professionals and the general public.

NCT07117916.

Diabetic foot is an infection, ulceration or destruction of the tissue of the foot of a person diagnosed with diabetes mellitus (DM). Diabetic foot ulcer (DFU) is a major and preventable complication of DM. Adequate knowledge and foot self-care practices are crucial to reduce the risk of DFU complications, particularly in resource-limited healthcare settings.

To assess the knowledge and practices related to foot self-care and associated factors among individuals diagnosed with diabetes attending diabetic clinics at all base hospitals in Colombo District, Sri Lanka.

An analytical cross-sectional study was conducted among 423 individuals diagnosed with diabetes attending the diabetic clinic at all three base hospitals in Colombo district, from January 2023 to March 2024 (study period). Participants were selected by using a systematic random sampling. Data were collected using a validated and pre-tested interviewer-administered questionnaire. Descriptive and inferential analyses were performed using Statistical Packages for Social Sciences V.26 software. Associations were examined using ² tests, independent sample t-tests and one-way ANOVA (Analysis of Variance), with a p value

The majority of the participants were females (71.2%). Among the participants, 33.8% of them had a poor level of knowledge regarding foot self-care. Knowledge level was significantly associated with the participants’ family history of diabetes and the hospital where they attended the clinic (p

Nearly one-third of participants demonstrated poor knowledge of foot self-care, despite over half exhibiting satisfactory foot-care practices. This gap highlights the need for targeted education to boost awareness and promote consistent foot care, which is a key step in preventing diabetic foot complications and improving long-term outcomes for individuals diagnosed with diabetes.

Stroke is one of the top causes of disability in Malaysia, yet caregivers have limited access to structured, culturally tailored education to support poststroke care.

To develop and validate the CaknaStrok Education Package (CEP), a blended learning intervention comprising a printed guidebook and a trilingual mobile health application for informal stroke caregivers in Malaysia.

Methodological study involving the development and validation of a caregiver education programme guided by the Analyse, Design, Develop, Implement, Evaluate (ADDIE) instructional design framework.

Development and validation were conducted in Malaysia between January 2022 and December 2023. Both experts and caregivers were recruited from two tertiary hospitals on the East Coast of Malaysia, with caregivers identified from inpatient wards and outpatient clinics at these hospitals.

Content validation involved 10 multidisciplinary experts. Face validation involved 14 informal stroke caregivers who met eligibility criteria, and all completed the study.

CEP was developed based on prior needs assessment and expert input. Content validation was undertaken using the Content Validity Index (CVI) and face validation using the Face Validity Index (FVI), both assessed on a four-point Likert scale. Qualitative feedback was also obtained from the participants.

CEP consists of six modules delivered via a printed guidebook and a trilingual app with videos, assessment tools and local resources. Experts rated the content highly valid (Scale-level (S)-CVI/the average method (Ave): 0.97–0.99 across domains). Caregivers reported strong acceptability (S-FVI/Ave: 0.95–0.99). Qualitative feedback from experts and caregivers informed refinements to content clarity, usability and presentation, including improved navigation, consistent language use and enhanced visual design. Suggestions requiring substantial structural changes were documented for future iterations.

The CEP shows strong content and face validity as a blended caregiver education tool. By combining printed and digital formats, CEP addresses cultural and access challenges and provides a scalable model for stroke caregiver education in Malaysia. Further pilot or feasibility studies are warranted to evaluate usability, engagement and implementation in real-world settings prior to effectiveness evaluation.

Primary sclerosing cholangitis (PSC) is the classical hepatobiliary manifestation of inflammatory bowel disease (IBD). No therapy currently halts disease progression. The strong gut–liver axis implicated in PSC pathogenesis supports the investigation of microbiome-targeted treatments. Oral vancomycin (OV), an antibiotic with potential immunomodulatory properties, has shown encouraging results in improving clinical symptoms and liver biochemistry in PSC. However, prospective data on its safety and efficacy remain limited.

Oral Vancomycin for primary sclerosing Cholangitis in ITaly (VanC-IT) is a phase II, dose-finding, randomised, placebo-controlled, trial designed to evaluate the efficacy and safety of OV in patients with PSC, with or without underlying IBD. Adults and adolescents aged 15–75 years will be enrolled following a 10-week screening and run-in period and randomised in a 1:1:1 ratio to receive either placebo, OV 750 mg/day or OV 1500 mg/day for 24 weeks. Randomisation will be stratified by baseline liver stiffness (

The protocol has been approved by the Ethics Committee CE Brianza on 10 February 2023, number 4017. Trial registration number NCT05876182. Participants will be required to provide written informed consent. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.

NCT05876182.

This study examined factors associated with the use of Indonesia’s National Health Insurance (NHI) among its beneficiaries in Maluku province.

Cross-sectional study.

The individual-level data were derived from the 2021 Social Health Insurance Sample Data. National health reports of Indonesia were used to provide the district-level variables. We performed multivariable logistic regression analyses to identify factors associated with NHI use among its beneficiaries in Maluku province.

Data were collected from 31 517 NHI beneficiaries registered in Maluku.

The primary outcome was the use of NHI insurance when accessing healthcare services (yes/no).

Only 14.79% of NHI beneficiaries in Maluku had ever used their insurance for healthcare services. Individual factors associated with higher NHI use included being under 60 years, females (adjusted OR (aOR)=1.29, p

Strengthening primary healthcare accessibility, improving the distribution of healthcare workers and addressing socioeconomic and geographical disparities are essential to ensure that the NHI scheme achieves equitable use across all regions in Maluku and other areas with similar settings.

Children from refugee families resettled in the USA face higher risks of serious mental health challenges compared with their native-born peers. Research shows that refugee youth in high-income countries frequently suffer from trauma-associated disorders such as post-traumatic stress disorder (PTSD), depression and anxiety. The high prevalence of trauma-associated mental health problems among these youth may be attributed to their own trauma exposure, especially if born in conflict zones, and post-resettlement challenges like poverty, acculturation difficulties, racism and discrimination. However, they may also suffer from the effects of intergenerational trauma, where parental war trauma impacts them. This study aims to adapt and test an intervention addressing intergenerational trauma-related emotional and behavioural health outcomes among US-born children of refugee parents in Omaha and Lincoln, Nebraska.

This is a two-arm cluster randomised type I hybrid effectiveness-implementation trial. Guided by the Social Action and Family Systems theories and applying them to the intergenerational transmission of trauma framework, the combination intervention consists of family strengthening model delivered through multiple family groups+peer mentoring programme called TeenAge Health Consultants (TAHC) adapted for delivery in virtual environment (Virtual TAHC). A total of 154 US-born adolescents of parent resettled as refugees (77 per study arm), ages 14–17 and at least one biological parent per youth (dyads) will be recruited from four comparable communities utilising community-based participatory research approach and randomised to usual care or intervention group. The intervention will be implemented for up to 16 weeks, with assessments at baseline, after intervention completion and 6 months follow-up. To determine study feasibility, we will use binary metrics of participant enrolment of 70% or more and retention of 80% or more at 12 months. To assess study acceptability, we will determine participant satisfaction with the study based on the Client Satisfaction Questionnaire (CSQ-8). To maximise rigour, our analyses will follow an intention-to-treat (ITT) approach. For primary inferential analyses, we will fit two-level generalised linear mixed models to continuous primary outcomes. The models will include fixed effects for study arm, time and their interaction terms. We will perform time-averaged comparisons of post-baseline repeatedly measured observations across study arms to examine intervention effects over the duration of the postintervention study period. To delineate barriers and facilitators to implementation and implementation strategies, we will apply a more integrative approach, using both inductive and deductive approaches guided by the grounded theory and integrative theory that combines both deductive and inductive approaches. Finally, we will integrate findings from the quantitative and qualitative analysis to provide additional explanation and context for our quantitative findings.

Voluntary written informed assent and consent will be obtained from all participants, adolescents and their parents, respectively. All study procedures received approval from Washington University in St. Louis Institutional Review Board (IRB #202307081).

Study findings will be disseminated through publications in scientific journals and presentations at national and international conferences. We also plan to provide community education about the study through a dissemination conference at the end of the study.

NCT06176638.

Equitable access to healthcare technology is a major public health issue. For adults with type 2 diabetes (T2D), continuous glucose monitoring (CGM) technology can improve diabetes self-management and clinical outcomes. Even though CGM is now recommended by professional guidelines for all patients with diabetes on insulin therapy, evidence suggests that CGM is underutilised and inequitably prescribed across health systems. As CGM is an emergent technology, it is vital to understand what approaches have been studied to overcome inequities in CGM access for adults with T2D, what aspects of equitable access have yet to be addressed and what are facilitators and barriers to CGM access at the individual, facility and health system levels.

We will use the Joanna Briggs Institute’s revised scoping review framework to conduct our analysis. The protocol is registered with Open Science Framework (https://osf.io/z2exn). We will search for peer-reviewed literature containing empirical evidence for the facilitators and barriers to equitable access to CGM technology for patients with T2D. Findings will be organised according to research objectives and the Framework for Digital Health Equity, and summarised using narrative synthesis of descriptive statistics for quantitative findings, and themes for qualitative findings. This review will be conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews.

The findings from this review will provide valuable information and support for future research into the equitable implementation and use of CGM for patients with T2D. We will disseminate findings at conferences and publish in a peer-reviewed journal.

https://osf.io/z2exn.