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A novel advanced synthetic bioactive glass matrix was studied in patients with non-healing diabetic foot ulcers (DFUs). Bioactive glasses can be constructed to be biocompatible, with water-soluble materials in multiple geometries including fibre scaffolds that mimic the 3D architecture of a fibrin clot. In this trial, chronic, Wagner Grade 1 DFUs were randomised to receive borate-based bioactive glass Fibre Matrix (BBGFM) plus standard of care (SOC) therapy for 12 weeks or SOC alone. The primary study endpoint was the proportion of subjects that obtained complete wound closure at 12 weeks. Secondary endpoints included time to achieve complete wound closure at 12 weeks. In the modified intent-to-treat (mITT) analysis, 48% (32/67) treated with BBGFM plus SOC healed at 12 weeks compared to 24% (16/66) with SOC alone (p = 0.007). In the per protocol (PP) population, 73% (32/44) of subjects treated with BBGFM plus SOC healed versus 42% (16/38) in the SOC group (p = 0.007). Based on the success of this trial, BBGFM demonstrates faster healing of DFUs compared to SOC and should be considered in the treatment armamentarium for Wagner Grade 1 DFUs. Future trials should investigate the use of BBGFM for healing deeper chronic DFUs, other wound aetiologies, or complex surgical wounds.
The use of invasive life support in patients with a prolonged critical illness clearly saves lives but carries substantial risks, including intensive care unit-acquired weakness (ICUAW) and long-term disability. Early mobilisation might improve outcomes, yet the evidence is conflicting and complicated by the lack of a responsive outcome measurement to detect change in critically ill patients’ physical function and activity. The Chelsea Critical Care Physical Assessment tool (CPAx) is a valid and reliable instrument for patients at risk of ICUAW. However, its ability to measure change over time (responsiveness) and the minimal clinically important difference (MCID) have not yet been rigorously investigated.
The primary objective of this prospective, international, multicentre, longitudinal cohort study is to investigate responsiveness and to establish the MCID of the CPAx during the ‘intensive care unit (ICU) period’, from ICU baseline to ICU discharge, and ‘hospital period’, from ICU to hospital discharge. Adults with any critical illness who are mechanically ventilated for at least 72 hours, expected to remain in ICU (≥48 hours) and being treated by a physiotherapist are eligible for study inclusion. Functional measurements, including the CPAx and a global rating of change (GRC) scale, will be collected during routine physiotherapy. Responsiveness will be evaluated primarily using the GRC as an anchor to distinguish changed from unchanged/deteriorated patients (criterion validity). As such, the magnitude of change will be analysed with receiver operating characteristics. Additionally, construct validity will be explored with correlation coefficients and effect sizes to confirm/reject a priori formulated hypotheses. MCID will be investigated with anchor-based and distribution-based methods. We plan to recruit 120 patients across three sites in Australia and Switzerland.
Ethical approval has been obtained from each local ethics committee (Canton of Bern, Switzerland (2024-00346), Monash Health, Australia (HREC/106143/MonH-2024-438474(v3)), the Alfred, Australia (490/24)). The results will be disseminated through international/national conferences, peer-reviewed journals and social media. The high quality, rigorous testing of the CPAx could benefit researchers, clinicians and patients.
Shared decision-making (SDM) between clinicians and patients is considered ‘best practice’. There is limited evidence regarding SDM in surgery, particularly in the emergency setting. Emergency SDM may be particularly challenging due to: time pressures, the patient’s underlying condition and the nature of the patient-surgeon interaction. However, emergency surgery arguably has a greater need for SDM due to the likelihood of disparate outcomes from intervention, which is dependent on the various treatment options available. This is necessary for patients to make informed decisions regarding their treatment of surgical pathology. The primary objective of this scoping review is to understand the extent and type of evidence in relation to SDM in emergency surgery to determine methods for improving SDM.
Any studies reporting SDM in emergency surgery on adult patients (age >18 years) will be included. EMBASE, Medline, Cochrane, CINAHL and Scopus databases will be searched for articles with no language or date limits. Studies will be screened by two independent reviewers, with consensus met prior to data extraction. Data extracted to include study design, details of study population, tools used to measure SDM, prevalence of SDM and barriers and enablers for SDM.
A systematic narrative synthesis will be performed following JBI (Joanna Briggs Institute) guidance. These will summarise findings of included studies. The findings may inform future research into facilitating implementation of SDM in emergency surgery.
This study does not require ethical approval. Final findings will be submitted for peer-reviewed publication and presentation at surgical conferences.
The Belgian healthcare system is to a large extent hospital-centred, prompting government initiatives to shift care towards patient’s homes and reduce hospital stays. To avoid unnecessary hospital stays and offer alternative and innovative forms of care, the Belgian federal health authorities selected five pilot projects for transmural care for chronically ill children. Guided by the Medical Research Council framework, this study aims to evaluate the paediatric transmural care projects to inform new models for paediatric care.
Using a mixed-methods realist evaluation, the study comprises three phases: (1) initial programme theory development, (2) initial programme theory testing and (3) programme theory refinement. In a first phase, the initial programme theory rooted in the normalisation process theory will be refined from insights retrieved from document review and focus group interviews with healthcare professionals. In the second phase, the initial programme theory will be tested using empirical data. Routine data and questionnaires will examine whether characteristics of participants and outcomes are in line with the quintuple aim framework. Focus groups with children, parents and stakeholders, and document analysis will be used to evaluate the structure of the intervention, examine the process and context, and understand more in-depth the outcomes. A budget impact analysis will be used to assess whether the pilot project is affordable. In a third phase, qualitative and quantitative data will be analysed using a convergent mixed-methods model, involving continuous triangulation of multiple data sets to facilitate greater understanding of the context and refinement of the programme theory.
The study protocol was reviewed and approved by the Ethics Committee of the Ghent University Hospital (Belgian Registration Number B6702024000193) after consultation with all Ethics Committees of the participating hospitals. Written informed consent will be obtained from participants or their legal representatives prior to data collection. Participant confidentiality will be maintained throughout the study. Study results will be published in international peer-reviewed journals and will be presented at national and international conferences. The general population will be informed of the aggregated results.
ClinicalTrials.gov, NCT06679595.
by Stephen Mensah Arhin, Kwesi Boadu Mensah, Isaac Tabiri Henneh, Felix Yirdong, Evans Kofi Agbeno, Charles Ansah, Martins Ekor
BackgroundPsychological distress and social burdens associated with infertility among couples have been well-documented. However, little is known about the specific coping strategies employed by couples in low-middle-income countries such as Ghana, in the aftermath of unsuccessful infertility treatment attempts. In this qualitative study, we explored specific coping strategies patients adopt to address psychological distress related to unsuccessful treatment for infertility.
MethodsA semi-structured interview approach was used to elicit qualitative responses from 18 fertility clients after unsuccessful treatment at four fertility clinics in Ghana. Thematic analysis (TA) was used to examine the coping strategies adopted by participants in response to psychological distress associated with infertility treatment failures. This allowed us to explore potential culturally specific coping strategies employed by participants in response to infertility-related psychological distress.
ResultsThe themes that emerged as coping strategies in response to infertility-related psychological distress were diversional activities, intrapersonal cognitive reframing, social isolation, familial support, religious coping, avoidance-focused coping strategies, seeking encouragement, and professional help.
ConclusionThe findings from this study indicate that coping strategies that involve isolating oneself may not provide lasting emotional relief for individuals experiencing infertility. Relational activities contribute positively to coping. This is relevant in helping health professionals in the management of infertility treatment failures, which may include setting up support groups of similar experiences to draw strength from each. Furthermore, the results underscore the need to integrate psychological interventions into the counseling of couples following an unsuccessful infertility treatment. The clinical and research implications of these findings are discussed.
by Basile Chrétien, Andry Rabiaza, Nishida Kazuki, Sophie Fedrizzi, Marion Sassier, Charles Dolladille, Joachim Alexandre, Xavier Humbert
IntroductionRecent literature has reported instances of drug associated with hypertension with serotonin reuptake inhibitors (SRIs). Nonetheless, the association between SRIs and hypertension development is the subject of ongoing debate. It remains uncertain whether this is indicative of a class effect, and if dose-effect exist. To investigate the potential class effect associating SRIs with hypertension reporting, we utilized real-world data from VigiBase®, the World Health Organization (WHO) pharmacovigilance database.
MethodsWe conducted an updated disproportionality analysis within VigiBase® to identify a signal of hypertension reporting with individual SRIs by calculating adjusted reporting odds ratios (aRORs) within a multivariate case/non-case study design. Additionally, we explored the presence of a dose-effect relationship.
ResultsThe database contained 13,682 reports of SRI associated with hypertension (2.2%), predominantly in women (70.0%). Hypertension was most reported in the 45-64 years old age group (44.8%). A total of 3,879 cases were associated with sertraline, 2,862 with fluoxetine, 2,516 with citalopram, 2,586 with escitalopram, 2,441 with paroxetine, 201 with fluvoxamine and 8 with zimeldine.A significant ROR was observed for all SRIs in both univariate (RORs ranging from 1.39 to 1.54) and multivariable analyses (aRORs ranging from 1.16 to 1.40) after adjustments for age group, sex, concurrent antihypertensive medication and drugs knowns to induce hypertension, except for fluvoxamine and zimeldine. No dose-response relationship was identified.
ConclusionThis investigation, conducted under real life conditions, unveils a notable pharmacovigilance safety signal associating SRI usage with hypertension reporting. No dose-response effect was detectable. Further longitudinal studies are warranted.
by Tamara Taggart, Allison Mathews, Toni Junious, Joseph A. Lindsey, Andrea Augustine, Charles Debnam, Yavonne Boyd, Seraiya Wright, Joseph D. Tucker, Manya Magnus
HIV incidence among young people (Black and Latinx women and men who have sex with men ages 16–24 years), in the United States is high. Traditional top-down approaches for pre-exposure prophylaxis (PrEP) social marketing are not effectively reaching this population. Crowdsourcing is a promising approach to engaging young people in the development of innovative solutions to raise awareness and use of PrEP among those at highest risk of HIV. This study engaged young people in the design and evaluation of an online crowdsourcing contest to promote PrEP among Washington, DC youth. The contest used standard methods recommended by the World Health Organization and feedback from our community partners. Online recruitment using social media elicited online votes and survey responses. We analyzed cross-sectional surveys using descriptive statistics, and semi-structured interviews with contest participants using thematic coding to explore barriers and facilitators to contest engagement. Approximately 82% of entries were from young people in DC. A convenience sample of 181 people voted on their favorite crowdsourced PrEP messages and shared their awareness and attitudes about PrEP. The contest website received 2,500 unique visitors and 4,600 page views. Themes from semi-structured interviews (n = 16) included the need for more community engagement in developing PrEP messaging and positive attitudes towards crowdsourcing. Survey data (n = 887) showed that the crowdsourced messages were well-liked and resonated with the community. Most preferred to see PrEP messages in social media (23%), email (17%) and videos (14%). Approximately 70% of survey participants reported that after viewing the crowdsourced message they would talk to their sexual partner or medical provider (63%) about PrEP, use PrEP (58%), and learn more about PrEP (56%). Crowdsourced messages solicit substantial online viewership. More implementation research is needed to understand the public health impact of integrating social media, crowdsourcing, and community engagement to develop PrEP promotional messages.As the incidence of diabetic foot ulcers (DFU) increases, better treatments that improve healing should reduce complications of these ulcers including infections and amputations. We conducted a randomized controlled trial comparing outcomes between a novel purified reconstituted bilayer membrane (PRBM) to the standard of care (SOC) in the treatment of non-healing DFUs. This study included 105 patients who were randomized to either of two treatment groups (n = 54 PRBM; n = 51 SOC) in the intent to treat (ITT) group and 80 who completed the study per protocol (PP) (n = 47 PRBM; n = 33 SOC). The primary endpoint was the percentage of wounds closed after 12 weeks. Secondary outcomes included percent area reduction, time to healing, quality of life, and cost to closure. The DFUs that had been treated with PRBM healed at a higher rate than those treated with SOC (ITT: 83% vs. 45%, p = 0.00004, PP: 92% vs. 67%, p = 0.005). Wounds treated with PRBM also healed significantly faster than those treated with SOC with a mean of 42 versus 62 days for SOC (p = 0.00074) and achieved a mean wound area reduction within 12 weeks of 94% versus 51% for SOC (p = 0.0023). There were no adverse events or serious adverse events that were related to either the PRBM or the SOC. In comparison to the SOC, DFUs healed faster when treated with PRBM. Thus, the use of this PRBM is an effective option for the treatment of chronic DFUs.
We report the first clinical evaluation of a new enzymatic wound debridement product containing tarumase in venous leg ulcer patients. As a first-in-human study, this was a prospective, open-label, multi-centre, dose escalation study across five dose cohorts and involving a total of 43 patients treated three times weekly for up to 4 weeks (12 applications). The primary and secondary endpoints of the study were to assess the systemic safety, local tolerability, and early proof of concept both for wound debridement and healing. Results indicated that the tarumase enzyme was well tolerated when applied topically to wounds, with no indications of systemic absorption, no evidence of antibody generation, and no systemic effects on coagulation pathways. Locally, there was no evidence of pain on application, no local itching, no increases in erythema, oedema, exudate or bleeding and only a few treatment emergent adverse events were reported. As the concentration of tarumase was escalated, trends towards faster and improved effectiveness of wound debridement were observed, especially in patients with significant slough at baseline. Trends towards faster rates of healing were also noted based on observations of increased granulation tissue, increased linear healing and reduction in surface area over the 4-week treatment period.
A novel autologous heterogeneous skin construct (AHSC) was previously shown to be effective versus standard of care (SOC) treatment in facilitating complete wound healing of Wagner 1 diabetic foot ulcers in an interim analysis of 50 patients previously published. We now report the final analysis of 100 patients (50 per group), which further supports the interim analysis findings. Forty-five subjects in the AHSC treatment group received only one application of the autologous heterogeneous skin construct, and five received two applications. For the primary endpoint at 12 weeks, there were significantly more diabetic wounds closed in the AHSC treatment group (35/50, 70%) than in the SOC control group (17/50, 34%) (p = 0.00032). A significant difference in percentage area reduction between groups was also demonstrated over 8 weeks (p = 0.009). Forty-nine subjects experienced 148 adverse events: 66 occurred in 21 subjects (42%) in the AHSC treatment group versus 82 in 28 SOC control group subjects (56.0%). Eight subjects were withdrawn due to serious adverse events. Autologous heterogeneous skin construct was shown to be an effective adjunctive therapy for healing Wagner 1 diabetic foot ulcers.
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