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A purified reconstituted bilayer matrix shows improved outcomes in treatment of non‐healing diabetic foot ulcers when compared to the standard of care: Final results and analysis of a prospective, randomized, controlled, multi‐centre clinical trial

Abstract

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.

Multicomponent processes to identify and prioritise low-value care in hospital settings: a scoping review

Por: Tyack · Z. · Carter · H. · Allen · M. · Senanayake · S. · Warhurst · K. · Naicker · S. · Abell · B. · McPhail · S. M.
Objectives

This scoping review mapped and synthesised original research that identified low-value care in hospital settings as part of multicomponent processes.

Design

Scoping review.

Data sources

Electronic databases (EMBASE, PubMed, CINAHL, PsycINFO and Cochrane CENTRAL) and grey literature were last searched 11 July and 3 June 2022, respectively, with no language or date restrictions.

Eligibility criteria

We included original research targeting the identification and prioritisation of low-value care as part of a multicomponent process in hospital settings.

Data extraction and synthesis

Screening was conducted in duplicate. Data were extracted by one of six authors and checked by another author. A framework synthesis was conducted using seven areas of focus for the review and an overuse framework.

Results

Twenty-seven records were included (21 original studies, 4 abstracts and 2 reviews), originating from high-income countries. Benefit or value (11 records), risk or harm (10 records) were common concepts referred to in records that explicitly defined low-value care (25 records). Evidence of contextualisation including barriers and enablers of low-value care identification processes were identified (25 records). Common components of these processes included initial consensus, consultation, ranking exercise or list development (16 records), and reviews of evidence (16 records). Two records involved engagement of patients and three evaluated the outcomes of multicomponent processes. Five records referenced a theory, model or framework.

Conclusions

Gaps identified included applying systematic efforts to contextualise the identification of low-value care, involving people with lived experience of hospital care and initiatives in resource poor contexts. Insights were obtained regarding the theories, models and frameworks used to guide initiatives and ways in which the concept ‘low-value care’ had been used and reported. A priority for further research is evaluating the effect of initiatives that identify low-value care using contextualisation as part of multicomponent processes.

Did the COVID-19 pandemic affect levels of burnout, anxiety and depression among doctors and nurses in Bangladesh? A cross-sectional survey study

Por: Hutchings · H. A. · Rahman · M. · Carter · K. · Islam · S. · O'Neill · C. · Roberts · S. · John · A. · Fegan · G. · Dave · U. · Hawkes · N. · Ahmed · F. · Hasan · M. · Azad · A. K. · Rahman · M. M. · Kibria · M. G. · Rahman · M. M. · Mia · T. · Akhter · M. · Williams · J. G.
Introduction

COVID-19 has caused severe disruption to clinical services in Bangladesh but the extent of this, and the impact on healthcare professionals is unclear. We aimed to assess the perceived levels of anxiety, depression and burnout among doctors and nurses during COVID-19 pandemic.

Methods

We undertook an online survey using RedCap, directed at doctors and nurses across four institutions in Bangladesh (The Sheikh Russel Gastro Liver Institute & Hospital (SRNGIH), Dhaka Medical College Hospital (DMCH), Mugda Medical College Hospital (MMCH) and M Abdur Rahim Medical College (MARMC) Hospital). We collected information on demographics, awareness of well-being services, COVID-19-related workload, as well as anxiety, depression and burnout using two validated questionnaires: the Hospital Anxiety and Depression Scale (HADS) and the Maslach Burnout Inventory (MBI).

Results

Of the 3000 participants approached, we received responses from 2705 (90.2%). There was a statistically significant difference in anxiety, depression and burnout scores across institutions (p

Conclusion

We identified a high prevalence of perceived anxiety, depression and burnout among doctors and nurses during the COVID-19 pandemic. This was worse in staff engaged in COVID-19-related activities. These findings could help healthcare organisations to plan for future similar events.

Prevalence and short-term change in symptoms of anxiety and depression following bariatric surgery: a prospective cohort study

Objectives

Bariatric surgery is an effective treatment for severe obesity that leads to significant physical health improvements. Few studies have prospectively described the short-term impact of surgery on mental health using standardised case-finding measures for anxiety or depressive disorders. This study describes the prevalence and short-term course of these conditions following surgery.

Design

Prospective observational cohort study.

Setting

12 National Health Service centres in England.

Participants

Participants studied took part in the By-Band-Sleeve study, a multicentre randomised controlled trial evaluating the surgical management of severe obesity. We included participants who had undergone surgery (gastric bypass, gastric band or sleeve gastrectomy) within 6 months of randomisation.

Primary and secondary outcome measures

Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline and 12 months post-randomisation. Sociodemographic variables collected at prerandomisation included body mass index, age, sex, ethnicity, marital status, tobacco use, employment status and income band.

Results

In our sample of 758 participants, 94.5% (n 716) and 93.9% (n 712) had completed baseline anxiety (HADS-A) and depression (HADS-D) subscales. At pre-randomisation 46.1% (n 330/716, 95% CI 42.4% to 49.7%) met clinical case criteria for anxiety and 48.2% (n 343/712, 95% CI 44.5% to 51.8%) for depression. Among participants returning completed 12 months post-randomisation questionnaires (HADS-A n 503/716, HADS-D n 498/712), there was a significant reduction in the proportion of clinical cases with anxiety (–9.5%, 95% CI –14.3% to -4.8% p

Conclusions

Almost half of people undergoing bariatric surgery had underlying anxiety or depressive symptoms. In the short term, these symptoms appear to substantially improve. Future work must identify whether these effects are sustained beyond the first post-randomisation year.

Trial registration number

NCT02841527 and ISRCTN00786323.

Direct-to-consumer tests advertised online in Australia and their implications for medical overuse: systematic online review and a typology of clinical utility

Por: Shih · P. · Ding · P. · Carter · S. M. · Stanaway · F. · Horvath · A. R. · Langguth · D. · Saad · M. · St John · A. · Bell · K.
Objectives

The objective of this study is to map the range and variety of direct-to-consumer (DTC) tests advertised online in Australia and analyse their potential clinical utility and implications for medical overuse.

Design

Systematic online search of DTC test products in Google and Google Shopping. DTC test advertisements data were collected and analysed to develop a typology of potential clinical utility of the tests at population level, assessing their potential benefits and harms using available evidence, informed by concepts of medical overuse.

Results

We identified 484 DTC tests (103 unique products), ranging from $A12.99 to $A1947 in cost (mean $A197.83; median $A148.50). Using our typology, we assigned the tests into one of four categories: tests with potential clinical utility (10.7%); tests with limited clinical utility (30.6%); non-evidence-based commercial ‘health checks’ (41.9%); and tests whose methods and/or target conditions are not recognised by the general medical community (16.7%). Of the products identified, 56% did not state that they offered pretest or post-test consultation, and 51% did not report analytical performance of the test or laboratory accreditation.

Conclusions

This first-in-Australia study shows most DTC tests sold online have low potential clinical utility, with healthy consumers constituting the main target market. Harms may be caused by overdiagnosis, high rates of false positives and treatment decisions led by non-evidence-based tests, as well as financial costs of unnecessary and inappropriate testing. Regulatory mechanisms should demand a higher standard of evidence of clinical utility and efficacy for DTC tests. Better transparency and reporting of health outcomes, and the development of decision-support resources for consumers are needed.

An examination of retracted articles in nursing literature

Abstract

Introduction

The output of scholarly publications in scientific literature has increased exponentially in recent years. This increase in literature has been accompanied by an increase in retractions. Although some of these may be attributed to publishing errors, many are the result of unsavory research practices. The purposes of this study were to identify the number of retracted articles in nursing and reasons for the retractions, analyze the retraction notices, and determine the length of time for an article in nursing to be retracted.

Design

This was an exploratory study.

Methods

A search of PubMed/MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, and Retraction Watch databases was conducted to identify retracted articles in nursing and their retraction notices.

Results

Between 1997 and 2022, 123 articles published in the nursing literature were retracted. Ten different reasons for retraction were used to categorize these articles with one-third of the retractions (n = 37, 30.1%) not specifying a reason. Sixty-eight percent (n = 77) were retracted because of an actual or a potential ethical concern: duplicate publication, data issues, plagiarism, authorship issues, and copyright.

Conclusion

Nurses rely on nursing-specific scholarly literature as evidence for clinical decisions. The findings demonstrated that retractions are increasing within published nursing literature. In addition, it was evident that retraction notices do not prevent previously published work from being cited. This study addressed a gap in knowledge about article retractions specific to nursing.

Associations of general and central adiposity with hypertension and cardiovascular disease among South Asian populations: a systematic review and meta-analysis

Por: Re · F. · Oguntade · A. S. · Bohrmann · B. · Bragg · F. · Carter · J. L.
Background

The relevance of measures of general and central adiposity for cardiovascular disease (CVD) risks in populations of European descent is well established. However, it is less well characterised in South Asian populations, who characteristically manifest larger waist circumferences (WC) for equivalent body mass index (BMI). This systematic review and meta-analysis provide an overview of the literature on the association of different anthropometric measures with CVD risk among South Asians.

Methodology

MEDLINE and Embase were searched from 1990 to the present for studies in South Asian populations investigating associations of two or more adiposity measures with CVD. Random-effects meta-analyses were conducted on the associations of BMI, WC and waist-to-hip ratio (WHR) with blood pressure, hypertension and CVD. Quality assessment was performed using the Newcastle-Ottawa scale.

Results

Titles and abstracts were screened for 7327 studies, yielding 147 full-text reviews. The final sample (n=30) included 2 prospective, 5 case-control and 23 cross-sectional studies. Studies reported generally higher risks of hypertension and CVD at higher adiposity levels. The pooled mean difference in systolic blood pressure (SBP) per 5 kg/m2 higher BMI was 3 mmHg (2.90 (95% CI 1.30 to 4.50)) and 6 mmHg (6.31 (95% CI 4.81 to 7.81) per 13 cm larger WC. The odds ratio (OR) of hypertension per 5 kg/m2 higher BMI was 1.33 (95% CI 1.18 to 1.51), 1.45 (95% CI 1.05 to 1.98) per 13 cm larger WC and 1.22 (95% CI 1.04 to 1.41) per 0.1-unit larger WHR. Pooled risk of CVD for BMI-defined overweight versus healthy-weight was 1.65 (95% CI 1.55 to 1.75) and 1.48 (95% CI 1.21 to 1.80) and 2.51 (95% CI 0.94 to 6.69) for normal versus large WC and WHR, respectively. Study quality was average with significant heterogeneity.

Conclusions

Measures of both general and central adiposity had similar, strong positive associations with the risk of CVD in South Asians. Larger prospective studies are required to clarify which measures of body composition are more informative for targeted CVD primary prevention in this population.

A multicenter, randomized controlled clinical trial evaluating the effects of a novel autologous heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Final analysis

Abstract

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.

Lifestyle behaviours and associated factors among people with type 2 diabetes attending a diabetes clinic in Ningbo, China: A cross-sectional study

by Naomi Carter, Jialin Li, Miao Xu, Li Li, Shengnan Xu, Xuelan Fan, Shuyan Zhu, Prit Chahal, Kaushik Chattopadhyay

The burden of type 2 diabetes (T2DM) in China is significant and growing, and this is reflected in high rates of T2DM in the city of Ningbo, China. Consequent impacts on morbidity, mortality, healthcare expenditure, and health-related quality of life, make this a problem of the utmost importance to address. One way to improve T2DM outcomes is to address lifestyle behaviours that may affect prognosis and complications, such as physical activity levels, dietary habits, smoking status, and alcohol intake. A cross-sectional survey was undertaken to describe the prevalence of being physically active, having a healthy diet, currently smoking, and currently drinking alcohol among people living with T2DM attending a diabetes clinic in Ningbo, China. Regression analysis was used to determine the factors associated with these lifestyle behaviours. We found a high prevalence of a healthy diet (97.8%, 95% CI 96.5–98.7%). Prevalence of being physically active (83.4%, 95% CI 80.6–85.9%), smoking (21.6%, 95% CI 18.8–24.6%), and alcohol drinking (32.9%. 95% CI 29.6–36.2%) appeared in keeping with those of the general population. Marked associations were demonstrated between male sex and smoking (OR 41.1, 95% CI 16.2–139.0), and male sex and alcohol drinking (OR 4.00, 95% CI 2.62–6.20). Correlation between lifestyle factors was demonstrated including between alcohol drinking and smoking, and between physical activity and reduced smoking. General diabetes self-management education programmes that address multiple lifestyle risk factors simultaneously may be beneficial in this population. Specific interventions targeting smoking cessation and reduction in alcohol drinking may be of benefit to men living with T2DM attending a diabetes clinic in Ningbo.

Dietary replacement of soybean meal with black soldier fly larvae meal in juvenile <i>Labeo rohita</i> and <i>Catla catla</i>: Effects on growth, nutritional quality, oxidative stress biomarkers and disease resistance

by Shafaq Fatima, Ayesha Afzal, Hamna Rashid, Saba Iqbal, Rosheen Zafar, Komal Khalid, Ayman Rauf, Maryam Majeed, Aqsa Malik, Chris G. Carter

This experiment aimed to investigate the effects of partial substitution of crude protein from soybean meal (SBM) with black soldier fly (Hermetia illucens) larvae meal (BSFLM) in juvenile rohu (Labeo rohita) and catla (Catla catla). Four isonitrogenous diets (23% crude protein) were formulated to replace 0% (T0), 40% (T40), 80% (T80) and 100% (T100) crude protein from SBM with BSFLM. Triplicate groups of each species (10 fish per replicate) were fed in an eight week growth experiment. After final sampling (n = 20 fish per dietary group), the remaining fish were exposed to bacterial (Staphylococcus aureus) challenge (0.80 CFU/ml) for 15 days. Rohu fed with BSFLM substituted diets showed significantly higher growth and feed conversion ratio as compared to those in T0. Catla fed with BSFLM substituted diets showed slightly higher growth indices. The growth response of rohu to BSFLM substitution was better than that noted in catla in all groups. The chemical composition, amino acids and fatty acids profile, haematological and biochemical parameters, levels of liver function enzymes measured in T0, T40, T80 and T100 were similar between four dietary groups in both species. However, the maximum value of cholesterol and triglycerides were noted in T100 both in catla and rohu. The values of lauric acid, α-linolenic acid, decosahexanoic acid, n3:n6 fatty acids ratio progressively increased with dietary increase of BSFLM in both species. At end of the growth experiment, the levels of catalase, superoxide dismutase and lysozyme increased linearly with the inclusion of BSFLM in both species while malondialdehyde showed similar values between different groups. However, catalase, and superoxide dismutase increased (T0

Provider cultural competence and humility in healthcare interactions with transgender and nonbinary young adults

Abstract

Purpose

Transgender and nonbinary (TGNB) patients experience many barriers when seeking quality healthcare services, including ineffective communication and negative relationships with their providers as well as a lack of provider competence (including knowledge, training, and experience) and humility (engagement in the process of self-reflection and self-critique) in treating TGNB individuals. The purpose of this qualitative study was to identify factors associated with cultural competence and humility that facilitate and impede effective relationships between TGNB young adults and their healthcare providers.

Methods

Data came from individual interviews with 60 young adults aged 18 to 24 from Florida who self-identified as transgender or nonbinary. We analyzed the data using inductive thematic approaches, and a feminist perspective, to identify themes associated with patient-provider relationships.

Conclusions

We identified 4 themes related to patient-provider relationships: (1) Participants indicated effective patient-provider communication and relationships are facilitated by providers requesting and utilizing TGNB patients' correct names and personal pronouns. (2) Participant narratives conveyed their preferences that providers “follow their lead” in terms of how they described their own anatomy, reinforcing the utility of cultural humility as an approach for interactions with TGNB patients (3) Participants discussed the detrimental effects of TGNB patients having to educate their own providers about their identities and needs, suggesting clinicians' competence regarding gender diversity is paramount to fostering and maintaining patient comfort. (4) Finally, participants' responses indicated concerns regarding the confidentiality and privacy of the information they provided to their providers, suggesting a lack of trust detrimental to the process of building rapport between patients and their providers.

Clinical Relevance

Our findings indicate balancing the use of cultural humility and cultural competence during clinical encounters with TGNB young adults can enhance patients' experiences seeking healthcare. Nursing education is often devoid of focus on caring for transgender and nonbinary persons. Additional provider training and education on approaching clinical encounters with TGNB patients with cultural humility and competence should improve patient-provider communication and relationships, leading to a higher quality of patient care.

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