Conectar
by Mengsi Peng, Peng Shen, Kyung-In Joung, Kwang Joon Kim
BackgroundAlthough metformin is the first-line medicine for type 2 diabetes (T2D), its safety profile in adolescents remains poorly understood. This study seeks to investigate the adverse events linked to metformin use in adolescents diagnosed with T2D.
MethodsData from the Food and Drug Administration Adverse Event Reporting System (FAERS), spanning Q1 2004 to Q2 2024, were retrospectively analyzed in this study. Adverse reactions were standardized using the Medical Dictionary for Regulatory Activities, then significant adverse drug reaction signals were identified through disproportionality analysis employing reporting odds ratio (ROR) and information component (IC) methods.
ResultsOf 17,956,653 FAERS reports, 80,187 involved metformin, including 973 in adolescents (10–19 years), with 174 cases were identified with a T2D indication. Analysis at the system organ class level revealed that congenital, familial, and genetic disorders [ROR: 8.8 (4.0, 19.3); IC: 2.2 (1.1, 2.9)] and pregnancy conditions [ROR: 4.9 (2.5, 9.5); IC: 1.8 (0.8, 2.5)] showed the most significant signals. At the preferred term (PT) level, three signals were identified across all sexes and subgroups: treatment noncompliance [ROR: overall 4.14 (2.44, 7.02), male 4.27 (2.00, 9.12), and female 4.65 (2.22, 9.74); IC: overall 1.67 (0.88, 2.22), male 1.60 (0.46, 2.36), and female 1.74 (0.60, 2.50)], lactic acidosis [IC: overall 2.99 (1.91, 3.72), male 2.53 (0.76, 3.61), and female 2.76 (1.34, 3.67)], and gastrointestinal disorder [ROR: overall 13.09 (4.73, 36.23), male 54.33 (6.05, 487.96), female 5.34 (1.10, 25.84)]. Neurological disorders were observed only in males, while pregnancy-related adverse effects and renal disorders occurred exclusively in females. Additionally, the study identified potential new signals not documented in metformin labeling, including areflexia, muscle weakness, ataxia, decreased vibratory sense, rhabdomyolysis, substance use, and axillary pain.
ConclusionThe study reveals a complex safety profile of metformin in adolescents with T2D, warranting further research to confirm risks.
by Yong Jae Lee, Nam Kyeong Kim, Kidong Kim, Chel Hun Choi, Keun Ho Lee, Jong-Min Lee, Kwang Beom Lee, Dong Hoon Suh, Sunghoon Kim, Min Kyu Kim, Seok Ju Seong, Myong Cheol Lim
ObjectiveTo identify the effect of fascial closure using barbed sutures on the incidence of incisional hernia in patients undergoing elective midline laparotomy for gynecological diseases.
MethodsIn this multicenter, non-blind randomized controlled trial conducted from February to December 2021, patients with a BMI 2 and aged >18 years, scheduled for midline laparotomy, were randomly assigned to receive either barbed (experimental) or non-barbed sutures (control) for fascial closure. The primary outcome was the cumulative incidence rate of incisional hernia up to 1-year post-surgery. Secondary outcomes included incisional hernia up to 2-years post-surgery, wound complications, and postoperative pain assessed by Brief Pain Inventory-Korean scores, and Numeric Rating Scale.
ResultsOut of 174 patients (experimental, 86; control, 88), 36 were excluded due to dropout or loss to follow-up, leaving 138 patients (experimental, 67; control, 71) included in the analysis. The groups were balanced in terms of cancer surgeries, mean wound length, and mean surgery time. The cumulative incidence rates of incisional hernia up to 1-year (0.0% vs. 1.4%; p > 0.999) and 2-years (0.0% vs. 3.4%, p = 0.496) post-surgery did not differ significantly between the experimental and control groups. Additionally, no significant differences were observed in the incidence of wound dehiscence 4 weeks post-surgery, cumulative incidences of wound dehiscence and wound infection up to 4 weeks post-surgery, or postoperative pain scores between the groups.
ConclusionsFascial closure using barbed sutures resulted in no cases of incisional hernia up to 2-years post-surgery, but did not demonstrate a significant reduction in incisional hernia rates compared with the non-barbed suture.
Trial registrationClinicalTrials.gov NCT04643197
Saskatchewan is facing a public health crisis driven by high rates of HIV, syphilis and hepatitis C virus (HCV) infections, particularly among people who use drugs. Injection drug use is a major contributor to these syndemic infections, exacerbated by structural barriers such as stigma, poverty and limited culturally safe healthcare. Innovative, community-informed approaches are urgently needed to improve prevention, testing and linkage to care.
This study will implement a rapid assessment and response system in Regina, Saskatchewan, Canada, integrating geospatial mapping of community needle prevalence with pop-up interventions. Needle hotspot maps will be used to guide the deployment of community-based pop-up events offering point-of-care testing for HIV, syphilis and HCV, alongside education on pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP). A convergent participatory mixed-methods design will be used to evaluate feasibility, acceptability and effectiveness, guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Quantitative data will assess changes in knowledge of PrEP and PEP, satisfaction with the intervention and report new diagnoses and participant demographics descriptively. A qualitative substudy will include 30 participants and will explore experiences with the intervention, barriers to care and perceptions of service delivery.
Ethical approval has been obtained from the research ethics board of the Saskatchewan Health Authority (#24–91). Findings will be disseminated through peer-reviewed publications, conference presentations and community reporting. This study may provide a model of community-based geospatial testing and education that could be scaled up and adapted elsewhere.
Open Science Framework https://doi.org/10.17605/OSF.IO/HVK3B
This study retrospectively reviewed 46 patients undergoing transmetatarsal amputation (TMA) between January 2017 and January 2023 to evaluate complication rates within 6 months and assess the predictive value of the SINBAD classification for re-amputation risk. Patients were categorised based on re-amputation occurrence, and clinical and demographic data were collected. Each case was evaluated using the SINBAD scoring system, with logistic regression used to assess associations. Among the patients, 28 (60.9%) experienced no re-amputation, while 18 (39.1%) underwent re-amputation. Baseline demographics and laboratory findings did not significantly differ between groups. The mean SINBAD score was significantly higher in the re-amputation group (3.67 vs. 2.29; p < 0.001), with logistic regression identifying SINBAD score as an independent predictor (OR 6.76; 95% CI: 2.18–21.02; p < 0.001). A SINBAD score of ≥ 4 was associated with a re-amputation rate of 90.9%. In conclusion, the SINBAD classification proves to be a simple and effective tool for predicting re-amputation post-TMA, facilitating risk stratification and surgical planning for diabetic foot ulcer patients.
To systematically review the existing literature and address the following research question: What are the most effective techniques used to minimise adverse effects resulting from subcutaneous injections of low-molecular-weight heparin among patients with cardiovascular diseases?
A scoping review.
A comprehensive search was conducted across multiple databases, including CINAHL, PubMed, EMBASE and the Cochrane Library, from 1 February 2014 to 31 January 2024. Participants were aged 18 years or older, diagnosed with venous thromboembolism or arterial thromboembolism and had prescribed subcutaneous injections of low-molecular-weight heparin. The collected data were analysed following the Joanna Briggs Institute approach, and it was organised and categorised based on the main objectives of the review.
Twenty studies were eligible, including 1 best practice project, 7 randomised controlled trials and 9 quasi-experimental studies. The techniques under investigation encompassed various aspects, including the injection site, injection duration (e.g., 30 s vs. 10 s), injection method (e.g., needle insertion angle), duration of needle withdrawal after injection, pressure application time and cold pressure. Preliminary evidence suggests that techniques such as using the abdominal site and slower injection rates may help reduce adverse effects. However, the optimal parameters for injection duration, waiting time, pressure and cold application, including the duration of these applications, remain uncertain due to limitations in sample size and heterogeneity in interventions and outcome measures across the studies.
Ensuring the accurate administration of low-molecular-weight heparin is of utmost importance as it plays a critical role in decreasing mortality rates and minimising substantial healthcare costs linked to complications arising from incorrect administration. The findings from the current review have significantly contributed to strengthening the evidence base in this field, providing more robust and reliable information.
This review emphasises the significance of implementing standardised subcutaneous injection techniques for low-molecular-weight heparin in patients with cardiovascular disease in order to reduce complications and enhance patient outcomes.
This study followed the applicable guidelines established by the PRISMA 2020 statement. The PRISMA checklist for systematic reviews was utilised for reporting purposes.
There is no patient or public contribution to declare.
OSF registries: osf.io/phk72
Haemodialysis is a life-sustaining treatment for patients suffering from advanced chronic kidney disease that persists without respite. Adherence to complex haemodialysis regimens demands rigorous self-management. Current literature has suggested the potential of novel telehealth technologies in supporting the self-management of haemodialysis patients, but this remains inconclusive.
To synthesise available evidence to determine the effectiveness of telehealth self-management interventions on the health outcomes of adults undergoing haemodialysis.
A systematic review and meta-analysis (reported according to the PRISMA Guidelines).
Nine electronic databases (PubMed, EMBASE, Cochrane Central Register of Controlled Trials, MEDLINE, CINAHL, PsycINFO, Scopus, Web of Science and ProQuest Dissertations & Theses Global), trial registries and grey literature were searched from inception till 1 December 2023 for randomised controlled trials on the effectiveness of telehealth self-management interventions for haemodialysis patients. Two independent reviewers performed screening, data extraction and risk-of-bias appraisal using Cochrane RoB tool-1. Meta-analyses using Review Manager Web synthesised the interventional effects. Cochrane GRADE assessed the overall quality of evidence.
Fifteen randomised controlled trials (involving 1003 participants) were included. Telehealth self-management interventions had a medium statistically significant effect on improving self-efficacy (SMD = 0.54, 95% CI [0.25, 0.83], Z = 3.69, p = 0.0002). Additional meta-analyses for the outcomes of knowledge, treatment adherence, health-related quality of life, inter-dialytic weight gain and serum electrolyte levels were non-statistically significant but appeared promising to be improved by telehealth self-management. The overall certainty of evidence for all outcomes was very low.
This review provided insights into the clinical importance of telehealth self-management interventions in self-efficacy enhancement among haemodialysis patients. Future researchers are encouraged to optimise telehealth components relevant to the worldwide needs and cultural diversity of adults undergoing haemodialysis.
Adoption of technological healthcare delivery is vital in establishing positive health outcomes and sustainability of routine patient care pathways.
None.
Registration: PROSPERO CRD42024438860
To synthesize evidence regarding the effectiveness of technology-based psychosocial interventions in improving health-related outcomes among family caregivers of stroke survivors.
A systematic review and meta-analysis was reported by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
Randomized controlled trials that investigated the effects of psychosocial interventions delivered through information and communication technologies on self-efficacy, caregiving competence, caregiver burden, perceived social support, anxiety, depression, health-related quality of life and cost-effectiveness were included. Two researchers independently selected studies, extracted data, and appraised the quality of the included studies. Subgroup analysis, sensitivity analysis, and narrative synthesis were conducted.
Ten electronic databases (PubMed, CENTRAL, Web of Science, Scopus, CINHAL, Embase, Institution of Electrical Engineers Xplore, Ovid Medline, PsycINFO, ProQuest Dissertations and Thesis) were searched up to February 2023.
Nineteen studies involving 1717 participants fulfilled the eligibility criteria. Technology-based psychosocial interventions significantly improved self-efficacy (SMD = .62), caregiving competence (SMD = .55), depression (SMD = −.25) and anxiety (SMD = −.35). However, perceived social support, caregiver burden, and health-related quality of life did not show significant improvements. Subgroup analyses revealed that the interventions, lasting from 4 to 6 weeks and encompassing comprehensive contents, exhibited larger effect sizes. None of the studies measured cost-effectiveness.
The technology-based psychosocial interventions are effective in enhancing self-efficacy and caregiving competence, as well as alleviating anxiety, and depression among family caregivers of stroke survivors. Future research should investigate interventions delivered through various digital platforms using well-designed RCTs with in-depth qualitative data collection and measurement of health and cost-effectiveness outcomes.
Through psychosocial interventions, healthcare providers in clinical and community settings, particularly nurses, could incorporate technologies into current stroke care practices.
It is not applicable as this is a systematic review.
The protocol was registered on PROSPERO (CRD42023402871).
FreshRSS 