Impact of wound duration on diabetic foot ulcer healing: evaluation of a new sucrose octasulfate wound dressing.

OBJECTIVE: A common and frequent complication of diabetes is diabetic foot ulcers (DFU), which can have high treatment costs and severe adverse events. This study aims to evaluate the effects of wound duration on wound healing and the impact on costs, including treatment with a new sucrose octasulfate dressing compared with a control dressing. METHOD: Based on the Explorer study (a two-armed randomised double-blind clinical trial), a cost-effectiveness analysis compared four different patient groups distinguished by their wound duration and additionally two DFU treatment options: a sucrose octasulfate dressing and a neutral dressing (as control). Clinical outcomes and total direct costs of wound dressings were evaluated over 20 weeks from the perspective of the Social Health Insurance in Germany. Simulation of long-term outcomes and costs were demonstrated by a five cycle Markov model. RESULTS: The results show total wound healing rates between 71% and 14.8%, and direct treatment costs for DFU in the range of €2482-3278 (sucrose octasulfate dressing) and €2768-3194 (control dressing). Patients with a wound duration of ≤2 months revealed the highest wound healing rates for both the sucrose octasulfate dressing and control dressing (71% and 41%, respectively) and had the lowest direct treatment costs of €2482 and €2768, respectively. The 100-week Markov model amplified the results. Patients with ≤2 months' wound duration achieved wound healing rates of 98% and 88%, respectively and costs of €3450 and €6054, respectively (CE=€3520, €6864). Sensitivity analysis revealed that the dressing changes per week were the most significant uncertainty factor. CONCLUSION: Based on the findings of this study, early treatment of DFU with a sucrose octasulfate dressing is recommended from a health economic view due to lower treatment costs, greater cost-effectiveness and higher wound healing rates.

Cost-effectiveness of TLC-sucrose octasulfate versus control dressings in the treatment of diabetic foot ulcers.

OBJECTIVE: Diabetes is one of the most widespread diseases in Germany. Common complications are diabetic foot ulcers (DFU), which are associated with a cost-intensive treatment and serious adverse events, such as infections, amputations. This cost-effectiveness analysis compares two treatment options for patients with DFU: a TLC-NOSF dressing versus a neutral dressing, assessed through a European double-blind randomised controlled trial (RCT), Explorer. METHODS: The evaluation of the clinical outcomes was associated to direct costs (costs for dressings, nursing time, hospitalisation etc.) of both dressings, from the perspective of the statutory health insurance in Germany. Due to the long mean healing time of a DFU, the observation period was extended from 20 to 100 weeks in a Markov model. RESULTS: After 20 weeks, and with complete closure as a primary endpoint, the model revealed direct treatment costs for DFU of €2,864.21 when treated with a TLC-NOSF dressing compared with €2,958.69 with the neutral control dressing (cost-effectiveness: €6,017.25 versus €9,928.49). In the Markov model (100 weeks) the costs for the TLC-NOSF dressing were €5,882.87 compared with €8,449.39 with the neutral dressing (cost-effectiveness: €6,277.58 versus €10,375.56). The robustness of results was underlined by several sensitivity analyses for varying assumptions. The frequency of weekly dressing changes had the most significant influence in terms of parameter uncertainty. CONCLUSION: Overall, the treatment of DFU with a TLC-NOSF dressing is supported from a health economic perspective, because both the treatment costs and the cost-effectiveness were superior compared with the neutral wound dressing.

Weight bias internalization, emotion dysregulation, and non-normative eating behaviors in prebariatric patients.

OBJECTIVE: Weight bias internalization (WBI) is associated with eating disorder psychopathology and non-normative eating behaviors among individuals with overweight and obesity, but has rarely been investigated in prebariatric patients. Based on findings demonstrating a relationship between emotion dysregulation and eating behavior, this study sought to investigate the association between WBI and eating disorder psychopathology as well as non-normative eating behaviors (i.e., food addiction, emotional eating, and eating in the absence of hunger), mediated by emotion dysregulation. METHOD: Within a consecutive multicenter study, 240 prebariatric patients were assessed using self-report questionnaires. The mediating role of emotion dysregulation was examined using structural equation modeling. RESULTS: The analyses yielded no mediational effect of emotion dysregulation on the association between WBI and eating disorder psychopathology. However, emotion dysregulation fully mediated the associations between WBI and emotional eating as well as eating in the absence of hunger. Further, emotion dysregulation partially mediated the relationship between WBI and food addiction symptoms. DISCUSSION: Prebariatric patients with high levels of WBI are at risk for non-normative eating behaviors, especially if they experience emotion regulation difficulties. These findings highlight the importance of interventions targeting WBI and improving emotion regulation skills for the normalization of eating behavior in prebariatric patients.

Nonnormative eating behavior and psychopathology in prebariatric patients with binge-eating disorder and night eating syndrome.

BACKGROUND: Binge-eating disorder (BED) as a distinct eating disorder category and night eating syndrome (NES) as a form of Other Specified Feeding or Eating Disorders were recently included in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). This study sought to investigate the prevalence of BED and NES and associations with various forms of nonnormative eating behavior and psychopathology in prebariatric patients. Within a consecutive multicenter registry study, patients in 6 bariatric surgery centers in Germany were recruited. METHODS: Overall, 233 prebariatric patients were assessed using the Eating Disorder Examination and self-report questionnaires. Assessment was unrelated to clinical procedures. RESULTS: Diagnostic criteria for full-syndrome BED and NES were currently met by 4.3% and 8.2% of prebariatric patients, respectively. In addition, 8.6% and 6.9% of patients met subsyndromal BED and NES criteria, respectively. Co-morbid BED and NES diagnoses were present in 3.9% of patients. In comparison to patients without any eating disorder symptoms, patients with BED and NES reported greater emotional eating, eating in the absence of hunger, and more symptoms of food addiction. Moreover, differences between patients with BED and NES emerged with more objective binge-eating episodes and higher levels of eating concern, weight concern, and global eating disorder psychopathology in patients with BED. CONCLUSION: BED and NES were shown to be prevalent among prebariatric patients, with some degree of overlap between diagnoses. Associations with nonnormative eating behavior and psychopathology point to their clinical significance and discriminant validity.

Influences of general self-efficacy and weight bias internalization on physical activity in bariatric surgery candidates.

BACKGROUND: Physical activity (PA) seems to be important for long-term weight loss after bariatric surgery; however, studies provide evidence for insufficient PA levels in bariatric patients. Research found self-efficacy to be associated with PA and weight bias internalization, for which an influence on mental and physical health has been shown in recent studies. The purpose of the present study was to investigate the influence of general self-efficacy on PA, mediated by weight bias internalization. METHODS: In 179 bariatric surgery candidates, general self-efficacy, weight bias internalization, and different intensities of PA were assessed by self-report questionnaires. Structural equation modeling was used to analyze the assumed mediational relationship. RESULTS: After controlling for sociodemographic variables, weight bias internalization fully mediated the association between general self-efficacy and moderate-intense as well as vigorous-intense PA. Lower general self-efficacy predicted greater weight bias internalization, which in turn predicted lower levels of moderate-intense and vigorous-intense PA. CONCLUSIONS: The results suggest an influence of weight bias internalization on preoperative PA in bariatric surgery candidates. Subsequently, implementation of interventions addressing weight bias internalization in the usual treatment of bariatric surgery candidates might enhance patients' preoperative PA, while longitudinal analyses are needed to further examine its predictive value on PA after bariatric surgery.

Quality of care in chronic leg ulcer in the community: introduction of quality indicators and a scoring system.

BACKGROUND: Treatment of chronic wounds is complex, particularly as a standard for the assessment and evaluation of quality of care is missing. OBJECTIVES: To develop indicators for quality of care in chronic wounds in general, and to evaluate the quality of care in leg ulcers in Hamburg, Germany, in particular. METHODS: Twenty indicators were derived from a national Delphi expert consensus to compute a single index of quality of care. This index was applied in a cross-sectional study involving a large spectrum of care providers and leg ulcer patients in the community. Trained wound experts interviewed and examined the patients, who had to complete standardized questionnaires. RESULTS: On average, 64% of the quality criteria were met in the consecutive sample of 502 patients with chronic leg ulcers of any origin; 75% of the patients were satisfied with their wound care. Predictors of quality of care are presented. CONCLUSIONS: This instrument is feasible, valid and ready for comparisons of patient groups, regions and care systems, and for optimization processes in wound care.

Combined alpha-methylacyl coenzyme A racemase/p53 analysis to identify dysplasia in inflammatory bowel disease.

Identification of dysplasia in inflammatory bowel disease represents a major challenge for both clinicians and pathologists. Clear diagnosis of dysplasia in inflammatory bowel disease is sometimes not possible with biopsies remaining "indefinite for dysplasia." Recent studies have identified molecular alterations in colitis-associated cancers, including increased protein levels of alpha-methylacyl coenzyme A racemase, p53, p16 and bcl-2. In order to analyze the potential diagnostic use of these parameters in biopsies from inflammatory bowel disease, a tissue microarray was manufactured from colons of 54 patients with inflammatory bowel disease composed of 622 samples with normal mucosa, 78 samples with inflammatory activity, 6 samples with low-grade dysplasia, 12 samples with high-grade dysplasia, and 66 samples with carcinoma. In addition, 69 colonoscopic biopsies from 36 patients with inflammatory bowel disease (28 low-grade dysplasia, 8 high-grade dysplasia, and 33 indefinite for dysplasia) were included in this study. Immunohistochemistry for alpha-methylacyl coenzyme A racemase, p53, p16 and bcl-2 was performed on both tissue microarray and biopsies. p53 and alpha-methylacyl coenzyme A racemase showed the most discriminating results, being positive in most cancers (77.3% and 80.3%) and dysplasias (94.4% and 94.4%) but only rarely in nonneoplastic epithelium (1.6% and 9.4%; P < .001). Through combining the best discriminators, p53 and alpha-methylacyl coenzyme A racemase, a stronger distinction between neoplastic tissues was possible. Of all neoplastic lesions, 75.8% showed a coexpression of alpha-methylacyl coenzyme A racemase and p53, whereas this was found in only 4 of 700 nonneoplastic samples (0.6%). alpha-methylacyl coenzyme A racemase/p53 coexpression was also found in 10 of 33 indefinite for dysplasia biopsies (30.3 %), suggesting a possible neoplastic transformation in these cases. Progression to dysplasia or carcinoma was observed in 3 of 10 p53/alpha-methylacyl coenzyme A racemase-positive, indefinite-for-dysplasia cases, including 1 of 7 cases without and 2 of 3 cases with p53 mutation. It is concluded that combined alpha-methylacyl coenzyme A racemase/p53 analysis may represent a helpful tool to confirm dysplasia in inflammatory bowel disease.