Systematic review and quality assessment of clinical and economic evidence for superabsorbent wound dressings in a population with chronic ulcers.

Effective exudate management is key for optimal ulcer healing. Superabsorbent dressings are designed to have high fluid handling capacity, reduced risk of exudate leakage, fluid retention under compression, and to sequester harmful exudate components. This study aimed to systematically identify existing evidence for the clinical efficacy and cost-effectiveness of superabsorbent dressings for the treatment of moderate-to-highly exudating chronic ulcers of various etiologies. The aim is focused on examining the 'class' effect of all superabsorbers, not any particular dressing. Clinical and cost effectiveness systematic reviews were conducted, searching Embase, MEDLINE, the Cochrane Library, and the Cumulative Index to Nursing and Allied Health Literature. The Cost Effectiveness Analysis Registry and Econ papers were also searched for the economic review. Outcomes of interest included ulcer closure, dressing properties, hospital- and infection-related outcomes, safety, and economic outcomes. Fourteen studies were included in the clinical systematic review. Eleven were case series, with one randomised controlled trial, one retrospective matched observational study, and one retrospective cohort study. The studies investigated eight superabsorbent dressings and were heterogeneous in their patient population and outcomes. Superabsorbent dressings may result in favourable outcomes, including reductions in frequency of dressing change and pain scores. As most studies were case series, drawing firm conclusions was difficult due to absence of a comparator arm. The economic systematic review identified seven studies, five of which were cost-utility analyses. These suggested superabsorbent dressings are a more cost-effective option for the treatment of chronic ulcers compared with standard dressings. However, the small number and low quality of studies identified in both reviews highlights the need for future research.

Prognostic models for clinical outcomes in patients with venous leg ulcers: A systematic review.

OBJECTIVE: The purpose of this review was to identify prognostic models for clinical application in patients with venous leg ulcers (VLUs). METHODS: Literature searches were conducted in Embase, Medline, Cochrane, and CINAHL databases from inception to December 22, 2021. Eligible studies reported prognostic models aimed at developing, validating, and adjusting multivariable prognostic models that include multiple prognostic factors combined, and that predicted clinical outcomes. Methodological quality was assessed using the CHARMS checklist and PROBAST short form questionnaire. RESULTS: Thirteen studies were identified, of which three were validation studies of previously published models, four reported derivation and validation of models, and the remainder reported derivation models only. There was substantial heterogeneity in the model characteristics, including 11 studies focused on wound healing outcomes reporting 91 different predictors. Three studies shared similar predicted outcomes, follow-up timepoint and used a Cox proportional hazards model. However, these models reported different predictor selection methods and different predictors and it was therefore not feasible to summarize performance, such as discriminative ability. CONCLUSIONS: There are no standout risk prediction models in the literature with promising clinical application for patients with VLUs. Future research should focus on developing and validating high-performing models in wider VLU populations.

Umbrella review and meta-analysis of reconstructed individual patient data of mortality following conventional endovascular and open surgical repair of infrarenal abdominal aortic aneurysm.

OBJECTIVES: This umbrella review aims to quality assess published meta-analyses, conduct a de-novo meta-analysis of the available randomized control trials (RCTs), and test the hypothesis that there is a long-term difference in mortality between OSR and EVAR. METHODS: A systematic search was conducted in MEDLINE and EMBASE's bibliographic databases (June 2022). Data were extracted using standardized extraction forms. The methodological quality of publications was assessed using the ROBIS tool. Data were analyzed with 'one-stage' and 'two-stage' approaches. RESULTS: According to two-stage analysis, EVAR has significantly favorable mortality for up to four years (increasing evidence). Subsequently, until the longest available time period, there is no difference between EVAR and OSR; all the results are statistically non-significant.In one stage analysis, the Cox model demonstrated a non-significant (weak evidence) hazard ratio of 1.03 (95% confidence interval [CI]: 0.94-1.12) in favor of OSR. The best-fitting parametric model (generalized gamma), leads to an hazard ratio of 0.97 (95% CI: 0.93-1.01) in favor of EVAR, with the results approaching significance (weak evidence). CONCLUSION: The results of this umbrella systematic review and meta-analysis failed to demonstrate any difference in long-term mortality following planned EVAR, compared with OSR of infrarenal AAA.

Individualized Risk Prediction for Improved Chronic Wound Management.

Significance: Chronic wounds are associated with significant morbidity, marked loss of quality of life, and considerable economic burden. Evidence-based risk prediction to guide improved wound prevention and treatment is limited by the complexity in their etiology, clinical underreporting, and a lack of studies using large high-quality datasets. Recent Advancements: The objective of this review is to summarize key components and challenges in the development of personalized risk prediction tools for both prevention and management of chronic wounds, while highlighting several innovations in the development of better risk stratification. Critical Issues: Regression-based risk prediction approaches remain important for assessment of prognosis and risk stratification in chronic wound management. Advances in statistical computing have boosted the development of several promising machine learning (ML) and other semiautomated classification tools. These methods may be better placed to handle large number of wound healing risk factors from large datasets, potentially resulting in better risk prediction when combined with conventional methods and clinical experience and expertise. Future Directions: Where the number of predictors is large and heterogenous, the correlations between various risk factors complex, and very large data sets are available, ML may prove a powerful adjuvant for risk stratifying patients predisposed to chronic wounds. Conventional regression-based approaches remain important, particularly where the number of predictors is relatively small. Translating estimated risk derived from ML algorithms into practical prediction tools for use in clinical practice remains challenging.

Challenges around quantifying uncertainty in a holistic approach to hard-to-heal wound management: Health economic perspective.

Treatment of hard-to-heal wounds involves a holistic approach for choosing between available treatment options. However, evidence for informing these choices is sparse, introducing uncertainty into decisions about the optimum treatment pathways that reflect the vast heterogeneity in this patient population. This paper discusses the existing clinical and health economic literature in order to provide insight into sources of uncertainty in the evaluation of the holistic approach to management of the hard-to-heal wounds, and how this uncertainty can be appropriately reflected in research. We identified three key sources of uncertainty in the evaluation of chronic wound treatments, namely heterogeneity in aetiology and patient populations, heterogeneity in treatment pathways, and challenges around capturing all relevant outcomes. Reflecting these complexities requires sophisticated modelling of treatment sequencing and long-term outcomes. The paper discusses how the scope specification, scenario analyses, and sensitivity analyses can be used to fully characterise analytical uncertainty.

Superabsorbent Wound Dressing for Management of Patients With Moderate-to-Highly Exuding Chronic Leg Ulcers: An Early Stage Model-Based Benefit-Harm Assessment.

The aim of the research is to assess the benefit-harm of superabsorbent polymers wound dressings based on polyacrylate polymers (SAPs) compared with standard of care (SoC) dressing mix for patients with moderate-to-highly exuding hard-to-heal leg ulcers. The SoC dressings mix was composed of other superabsorbents in 29% of cases, antimicrobials 26%, foams 20%, alginates 5%, and other dressings 19% weighted according to their frequency. We have used the decision-analytic modeling method, Markov process, as an adequate analytical solution for medical prognosis. We have combined the systematic literature search to identify the most relevant inputs for the analysis, with available patient-level clinical data concerning benefits of superabsorbent to generate a robust prediction of patient-relevant outcomes, including healing rates and health-related quality of life. Besides, we have qualitatively described adverse events associated with those treatments. Our research indicates that SAPs when compared with SoC dressing mix in a patient with moderate-to-highly excluding leg ulcers are leading to an improved healing rate with an absolute risk difference of 2.20% in 6 months and a relative risk of 1.07 in favor of SAP dressings. The attributable fraction among those exposed to SAP dressings of 6.6%, meaning that 6.6% of the healed ulcers could be attributed to having had the SAP dressing treatment instead of the SoC dressing treatment. Besides, SAP dressings lead to improved quality of life measured as incremental quality-adjusted life weeks (QALWs) of 0.13 QALWs.

Superabsorbent wound dressings versus foams dressings for the management of moderate-to-highly exuding venous leg ulcers in French settings: An early stage model-based economic evaluation.

Venous leg ulcers (VLUs) are the most common hard-to-heal ulcers associated with the high humanistic and economic burden. Especially clinically challenging are moderate-to-highly exuding venous leg ulcers, and current management guidelines recommend several different wound dressings for this indication. The study aimed to determine the cost-effectiveness of managing moderate-to-highly exuding venous leg ulcers with superabsorbent wound dressings versus foams dressings in French settings from Haute Autorité de Santé perspective. For evidence synthesis decision-analytic model was developed in line with international and French good modelling practices recommendations. All model inputs were informed by data identified through systematic literature reviews that, in our best knowledge, represent the best available evidence at this moment. According to the prediction from this early stage health economic evaluation, using superabsorbent wound dressings versus foam dressings mix in patients with moderate-to-highly exuding leg ulcers in French settings will result in an improved healing rate of 2.58%, incremental HRQoL of 0.143 QALWs and total direct cost savings of € 435 (USD 473) per patient over six months period. The clinical outcomes results from this evaluation are in line with management guidelines that have recommended superabsorbent wound dressings as a first-line choice in the therapy of moderate-to-highly exuding venous leg ulcers. In addition, this evaluation demonstrates that using superabsorbent wound dressings will also lead to economic savings from the Haute Autorité de Santé perspective.

Burden and severity of disease of aromatic L-amino acid decarboxylase deficiency: a systematic literature review.

OBJECTIVE: The objective was to investigate the severity of aromatic L-amino acid decarboxylase deficiency (AADCd) as reported in the published literature and to collate evidence of the clinical manifestations of AADCd, and the impact of the disease on patients, caregivers, and healthcare systems. METHODS: Published articles reporting severity of disease or disease impact were eligible for inclusion in this review. Articles were searched in MEDLINE, EMBASE, Cochrane CENTRAL, TRIP medical, and CRD databases in October 2021. The quality of the included studies was investigated using a modified version of the grading system of the Centre for Evidence-Based Medicine (CEBM). Descriptive data of the literature was extracted and a narrative synthesis of the results across studies was conducted. This review is reported according to the PRISMA reporting guidelines for systematic reviews. RESULTS: The search identified 970 unique reports, of which 59 met eligibility criteria to be included in the review. Of these, 48 included reports provided details on the clinical manifestations of AADCd. Two reports explored the disease impact on patients, while four described the impact on caregivers. Five reports assessed the impact on healthcare systems. Individuals with AADCd experience very severe clinical manifestations regardless of motor milestones achieved, and present with a spectrum of other complications. Individuals with AADCd present with very limited function, which, in combination with additional complications, substantially impact the quality-of-life of individuals and their caregivers. The five studies which explore the impact on the healthcare system reported that adequate care of individuals with AADCd requires a vast array of medical services and supportive therapies. CONCLUSIONS: Irrespective of the ambulatory status of individuals, AADCd is a debilitating disease that significantly impacts quality-of-life for individuals and caregivers. It impacts the healthcare system due to the need for complex coordinated activities of a multidisciplinary specialist team.

Cost-effectiveness analysis of superabsorbent wound dressings in patients with moderate-to-highly exuding leg ulcers in Germany.

The study aims to estimate the cost-effectiveness of superabsorbent wound dressings compared to the standard-of-care (SoC) dressings mix for treatment of patients with moderate-to-highly exuding leg ulcers in the German healthcare settings. A model-based cost-effectiveness analysis was conducted from the German statutory health insurance perspective, following German specific and international recommendations of good research practice. An individual-level (microsimulation) state-transition model has been used with a cycle length of 1 week and time horizon of 6 months. Several comprehensive systematic reviews were conducted to inform all model inputs, including clinical parameters, efficacy, quality of life, resources utilisation, and cost inputs. In addition, primary data from two clinical trials were used. Based on this cost-effectiveness analysis, using superabsorbent wound dressings instead of the SoC dressings of patients with moderate-to-highly exuding leg ulcers in Germany can lead to an improved healing rate of 2.57% (benefit ratio 1.08), improved health-related quality of life of 0.152 quality-adjusted life weeks, and total direct cost savings of €771 per patient in 6 months. Robustness of results was confirmed in sensitivity and scenario analyses.

Adverse events in second- and third-line treatments for acute and chronic graft-versus-host disease: systematic review.

BACKGROUND: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is associated with an increased risk of graft-versus-host disease (GvHD), a strong prognostic predictor of early mortality within the first 2 years following allo-HSCT. The objective of this study was to describe the harm outcomes reported among patients receiving second- and third-line treatment as part of the management for GvHD via a systematic literature review. METHODS: A total of 34 studies met the systematic review inclusion criteria, reporting adverse events (AEs) across 12 different second- and third-line therapies. RESULTS: A total of 14 studies reported AEs across nine different therapies used in the treatment of acute GvHD (aGvHD), 17 studies reported AEs of eight different treatments for chronic GvHD (cGvHD) and 3 reported a mixed population. Infections were the AE reported most widely, followed by haematologic events and laboratory abnormalities. Reported infections per patient were lower under extracorporeal photopheresis (ECP) for aGvHD (0.267 infections per patient over 6 months) relative to any of the therapies studied (ranging from 0.853 infections per patient per 6 months under etanercept up to 1.998 infections per patient on inolimomab). CONCLUSION: The reported incidence of infectious AEs in aGvHD and grade 3-5 AEs in cGvHD was lower on ECP compared with pharmaceutical management.

Bariatric surgery for patients with type 2 diabetes mellitus requiring insulin: Clinical outcome and cost-effectiveness analyses.

BACKGROUND: Although bariatric surgery is well established as an effective treatment for patients with obesity and type 2 diabetes mellitus (T2DM), there exists reluctance to increase its availability for patients with severe T2DM. The aims of this study were to examine the impact of bariatric surgery on T2DM resolution in patients with obesity and T2DM requiring insulin (T2DM-Ins) using data from a national database and to develop a health economic model to evaluate the cost-effectiveness of surgery in this cohort when compared to best medical treatment (BMT). METHODS AND FINDINGS: Clinical data from the National Bariatric Surgical Registry (NBSR), a comprehensive database of bariatric surgery in the United Kingdom, were extracted to analyse outcomes of patients with obesity and T2DM-Ins who underwent primary bariatric surgery between 2009 and 2017. Outcomes for this group were combined with data sourced from a comprehensive literature review in order to develop a state-transition microsimulation model to evaluate cost-effectiveness of bariatric surgery versus BMT for patients over a 5-year time horizon. The main outcome measure for the clinical study was insulin cessation at 1-year post-surgery: relative risks (RR) summarising predictive factors were determined, unadjusted, and after adjusting for variables including age, initial body mass index (BMI), duration of T2DM, and weight loss. Main outcome measures for the economic evaluation were total costs, total quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER) at willingness-to-pay threshold of GBP£20,000. A total of 2,484 patients were eligible for inclusion, of which 1,847 had 1-year follow-up data (mean age of 51 years, mean initial BMI 47.2 kg/m2, and 64% female). 67% of patients no longer required insulin at 1-year postoperatively: these rates persisted for 4 years. Roux-en-Y gastric bypass (RYGB) was associated with a higher rate of insulin cessation (71.7%) than sleeve gastrectomy (SG; 64.5%; RR 0.92, confidence interval (CI) 0.86-0.99) and adjustable gastric band (AGB; 33.6%; RR 0.45, CI 0.34-0.60; p < 0.001). When adjusted for percentage total weight loss and demographic variables, insulin cessation following surgery was comparable for RYGB and SG (RR 0.97, CI 0.90-1.04), with AGB having the lowest cessation rates (RR 0.55, CI 0.40-0.74; p < 0.001). Over 5 years, bariatric surgery was cost saving compared to BMT (total cost GBP£22,057 versus GBP£26,286 respectively, incremental difference GBP£4,229). This was due to lower treatment costs as well as reduced diabetes-related complications costs and increased health benefits. Limitations of this study include loss to follow-up of patients within the NBSR dataset and that the time horizon for the economic analysis is limited to 5 years. In addition, the study reflects current medical and surgical treatment regimens for this cohort of patients, which may change. CONCLUSIONS: In this study, we observed that in patients with obesity and T2DM-Ins, bariatric surgery was associated with high rates of postoperative cessation of insulin therapy, which is, in turn, a major driver of overall reductions in direct healthcare cost. Our findings suggest that a strategy utilising bariatric surgery for patients with obesity and T2DM-Ins is cost saving to the national healthcare provider (National Health Service (NHS)) over a 5-year time horizon.

Cost-effectiveness of superabsorbent wound dressing versus standard of care in patients with moderate-to-highly exuding leg ulcers.

OBJECTIVE: To determine the cost-effectiveness/utility of a superabsorbent wound dressing (Zetuvit Plus Silicone) versus the current standard of care (SoC) dressings, from the NHS perspective in England, in patients with moderate-to-high exudating leg ulcers. METHOD: A model-based economic evaluation was conducted to analyse the cost-effectiveness/utility of a new intervention. We used a microsimulation state-transition model with a time horizon of six months and a cycle length of one week. The model uses a combination of incidence base and risk prediction approach to inform transition probabilities. All clinical efficiency, health-related quality of life (HRQoL), cost and resource use inputs were informed by conducting a systematic review of UK specific literature. RESULTS: Treatment with the superabsorbent dressing leads to a total expected cost per patient for a six month period of £2887, associated with 15.933 expected quality adjusted life weeks and 10.9% healing rate. When treated with SoC, the total expected cost per patient for a six month period is £3109, 15.852 expected quality adjusted life weeks and 8% healing rate. Therefore, the superabsorbent dressing leads to an increase in quality-adjusted life weeks, an increase in healing rate by 2.9% and a cost-saving of £222 per single average patient over six months. Results of several scenario analyses, one-way deterministic sensitivity analysis, and probabilistic sensitivity analysis confirmed the robustness of base-case results. The probabilistic analysis confirmed that, in any combination of variable values, the superabsorbent dressing leads to cost saving results. CONCLUSION: According to the model prediction, the superabsorbent dressing leads to an increase in health benefits and a decrease in associated costs of treatment.

Congenital heart defect repair with ADAPT tissue engineered pericardium scaffold: An early-stage health economic model.

OBJECTIVE: The objective of this study was to evaluate the cost effectiveness of tissue engineered bovine tissue pericardium scaffold (CardioCel) for the repair of congenital heart defects in comparison with surgery using xenogeneic, autologous, and synthetic patches over a 40-year time horizon from the perspective of the UK National Health Service. METHODS: A six-state Markov state-transition model to model natural history of disease and difference in the interventional effect of surgeries depending on patch type implanted. Patches differed regarding their probability of re-operation due to patch calcification, based on a systematic literature review. Transition probabilities were based on the published literature, other clinical inputs were based on UK registry data, and cost data were based on UK sources and the published literature. Incremental cost-effectiveness ratio (ICER) was determined as incremental costs per quality adjusted life years (QALY) gained. We used a 40-year analytic time-horizon and adopted the payer perspective. Comprehensive sensitivity analyses were performed. RESULTS: According to the model predictions, CardioCel was associated with reduced incidence of re-operation, increased QALY, and costs savings compared to all other patches. Cost savings were greatest compared to synthetic patches. Estimated cost savings associated with CardioCel were greatest within atrioventricular septal defect repair and lowest for ventricular septal defect repair. Based on our model, CardioCel relative risk for re-operations is 0.938, 0.956and 0.902 relative to xenogeneic, autologous, and synthetic patches, respectively. CONCLUSION: CardioCel was estimated to increase health benefits and save cost when used during surgery for congenital heart defects instead of other patches.

Systematic assessment of decision-analytic models evaluating diagnostic tests for acute myocardial infarction based on cardiac troponin assays.

INTRODUCTION: Despite the emphasis on the clinical importance of cardiac troponin assays (cTn), there are insufficient cost-effectiveness comparisons of various troponin test protocols for the diagnosis of myocardial infarction (MI). Therefore, the purpose of the review was to identify and systematically assess published economic evaluations using decision-analytic models for diagnostic testing strategies based on cTn and to make recommendations for the development of future models. AREAS COVERED: MEDLINE, Science Direct, Cochrane Database, CRD Database, and gray literature were screened for full economic evaluation studies with relevant clinical outcomes over a defined time horizon addressing a population with suspected MI and comparison of different diagnostic test strategies. Standardized forms for data extraction and evidence tables were used for the summary of study design, methodological framework and data sources. Studies were assessed for quality using the CHEERS and the BMJ checklists. EXPERT COMMENTARY: Although there are 11 identified studies and several well-designed models, there remains a need for decision-analytic models including differential diagnosis for acute MI, different health facility configurations, clinician preferences, and behavioral components, and in the top of the subgroup analyses additional important personalized medicine aspects.

Relationship between the Manner of Mobile Phone Use and Depression, Anxiety, and Stress in University Students.

Objectives: There is insufficient evidence regarding the potential risk of mobile phone use on mental health. Therefore, the aim of this research was to examine the relationship between mobile phone use and mental health by measuring the levels of depression, anxiety, and stress among university students in Serbia and Italy. Methods: This cross-sectional study was carried out at two distinguished universities in Serbia and Italy from March to May of the 2015/2016 academic year and included 785 students of both genders. The questionnaire was compiled and developed from different published sources regarding the manner and intensity of mobile phone use, along with the Depression Anxiety Stress Scale (DASS 42) for measuring psychological health. The statistical analysis of the data included the application of binary logistic regression and correlation tests. Results: Statistical analysis indicates that anxiety symptoms are somewhat more present in younger students (odds ratio (OR) = 0.86, 95% confidence interval (CI): 0.76-0.96), in those who send more text messages SMSs (OR = 1.15, 95% CI: 1.11-1.31), and in those who browse the internet less frequently (OR = 0.84, 95% CI: 0.73-0.95). Stress is more common in students who make fewer calls a day (OR = 0.79, 95% CI: 0.64-0.97), as well in those who spend more time talking on the mobile phone per day (OR = 1.28, 95% CI: 1.12-1.56). The strongest predictor of high stress levels was keeping the mobile phone less than 1 m away during sleeping (OR = 1.48, 95% CI: 1.12-2.08). Conclusions: The results indicated that the intensity and modality of mobile phone use could be a factor that can influence causal pathways leading to mental health problems in the university student population.

Knowledge, Attitudes Toward, and Acceptability of Genetic Modification among Western Balkan University Students of Life Sciences (AGREE Study).

BACKGROUND: There are still no data on the attitudes and acceptance of genetic modification (GM) food in European developing countries, such as the Western Balkan countries. The aim of the study was to assess the knowledge, attitudes, and acceptance of GM but also to shed light on the multifactorial process leading to acceptance of genetic modifications among Western Balkan students of life sciences. METHODS: In this cross-sectional study, the final study population sample was composed of 1251 university students. The instrument for data collection was a questionnaire consisting of 49 items composed of 5 sections taken from the literature. Attitudes toward GM were analyzed by using Q-mode factor analysis and principal component analysis was run for the assessment of perception of personal health risks. The acceptability of GM was analyzed in binary probit models assessing the acceptability of GM products in different areas of application with Q models, sociodemographic variables, perception of personal health risks factors, respondents' knowledge about biotechnology, gender, and age as explanatory variables. RESULTS: This study demonstrated that students of life sciences supported the implementation of GM in industry and medicine production but not in food production. Their acceptance was most influenced by 3 out of 5 attitude models that were identified (p < 0.0001). Regarding the perception of personal health risks, the factor "credence risks" was seen as a negative predictor of acceptance of GM in industry and food production (p < 0.05). The main knowledge predictor of rejecting GM was misconception, whereas real knowledge had no impact (p < 0.0001). CONCLUSION: The AGREE study provided the first rough picture of the knowledge, attitudes, and acceptance of GM in this area. Given the target population, it could be expected that the general population's acceptance of all observed elements, especially knowledge, would be lower.

Organizational commitment and job satisfaction among nurses in Serbia: a factor analysis.

BACKGROUND: One of the basic prerequisites of efficient organizational management in health institutions is certainly monitoring and measuring satisfaction of employees and their commitment to the health institution in which they work. The aim of this article was to identify and test factors that may have a predictive effect on job satisfaction and organizational commitment. METHODS: We conducted a cross-sectional study that included 1,337 nurses from Serbia. Data were analyzed by using exploratory factor analysis, multivariate regressions, and descriptive statistics. RESULTS: The study identified three major factors of organizational commitment: affective commitment, disloyalty, and continuance commitment. The most important predictors of these factors were positive professional identification, extrinsic job satisfaction, and intrinsic job satisfaction (p < .0001). Predictors significantly affecting both job satisfaction and organizational commitment were identified as well; the most important of which was positive professional identification (p < .0001). CONCLUSIONS: This study identified the main factors affecting job satisfaction and organizational commitment of nurses, which formed a good basis for the creation of organizational management policy and human resource management policy in health institutions in Serbia.