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Introduction: The aim was to determine the cost-effectiveness and cost-utility of additional hyperbaric oxygen therapy (HBOT) compared to standard care (SC) for ischaemic diabetic foot ulcers (DFUs) regarding limb salvage and health status., Methods: An economic analysis was conducted, comprising cost-effectiveness and cost-utility analyses, with a 12-month time horizon, using data from the DAMO₂CLES multicentre randomised clinical trial. Cost-effectiveness was defined as cost per limb saved and cost-utility as cost per quality-adjusted life year (QALY). The difference in cost effectiveness between HBOT+SC and SC alone was determined via an incremental cost-effectiveness ratio (ICER)., Results: One-hundred and twenty patients were included, with 60 allocated to HBOT+SC and 60 to SC. No significant cost difference was found in the intention-to-treat analysis: €3,791 (bias corrected and accelerated [BCA] 95% CI, €3,556 - €-11,138). Cost per limb saved showed an ICER of €37,912 (BCA 95% CI €-112,188 - €1,063,561) for HBOT+SC vs. SC. There was no significant difference in mean QALYs: 0.54 for HBOT+SC vs. 0.56 for SC alone (-0.02; BCA 95% CI -0.11-0.08). This resulted in a cost-utility of minus €227,035 (BCA 95% CI €-361,569,550 - €-52,588) per QALY. Subgroup analysis for Wagner stages III/IV showed an ICER of €19,005 (BCA 95%CI, -€18,487 - €264,334) while HBOT did not show any benefit for Wagner stage II., Conclusions: HBOT as an adjunct to SC showed no significant differences in costs and effectiveness for patients with DFUs regarding limb salvage and health status. However, for patients with Wagner stage III/IV ischaemic DFUs there was a trend towards better effectiveness and cost-effectiveness., Competing Interests: No conflicts of interest were declared., (Copyright: This article is the copyright of the authors who grant Diving and Hyperbaric Medicine a non-exclusive licence to publish the article in electronic and other forms.)

In the Netherlands the primary care (General Practitioner or homecare nurse) encounter a variety of wounds ranging from traumatic to diabetic foot ulcers. According to a recent study 82.4% of the patients with a wound can be treated in a primary setting with the GP as medical supervisor. The remaining 17.6% of patients need more extensive care including advice by a specialised doctor, diagnosis and treatment. Prompt analyses and treatment of underlying causes by specialised doctors in a multidisciplinary setting is necessary for treating patients with complicated wound. This article describes the impact of Electronic Health Consultation on all wounds treated in the primary care. And describes the effect on the duration until referral to the hospital and the influence on the amount of unnecessary referrals to the hospital. All data was collected prospectively from June 2020 until October 2021. The study involved a process where primary care could seek advice from a Wound Physician at the Alrijne Wound Centre through a specialised Electronic Health Consultation. A total of 118 patients were analysed. 41/118 (34.7%) patients required a physical consultation with analysis and treatment in the hospital, after teleconsultation. The remaining 77/118 (65.3%) could be treated in primary care after Electronic Health Consultation. The mean duration of wound existence until Electronic Health Consultation was 39.3 days (range 5-271, SD: 38.5). 3/41 (7.3%) of the referrals were unnecessary. Electronic Health Consultation serves as a valuable and efficient tool for enhancing wound care, ultimately contributing to improved patient management and resource allocation within the healthcare system. This article describes the impact of Electronic Health Consultation on all wounds treated in the primary care and the influence on the duration until referral to the hospital and the influence on the amount of unnecessary referrals to the hospital., (© 2024 The Wound Healing Society.)

Funding of research by industry in general can lead to sponsorship bias. The aim of the current study was to conduct an initial exploration of the impact of sponsorship bias in observational alcohol research by focusing on a broad spectrum of health outcomes. The purpose was to determine whether the outcome depended on funding source. We focused on moderate alcohol consumption and used meta-analyses that are the basis of several international alcohol guidelines. These meta-analyses included observational studies that investigated the association of alcohol consumption with 14 different health outcomes, including all-cause mortality, several cardiovascular diseases and cancers, dementia, and type 2 diabetes. Subgroup analyses and metaregressions were conducted to investigate the association between moderate alcohol consumption and the risk of different health outcomes, comparing findings of studies funded by the alcohol industry, ones not funded by the alcohol industry, and studies with an unknown funding source. A total of 386 observational studies were included. Twenty-one studies (5.4%) were funded by the alcohol industry, 309 studies (80.1%) were not funded by the alcohol industry, and for the remaining 56 studies (14.5%) the funding source was unknown. Subgroup analyses and metaregressions did not show an effect of funding source on the association between moderate alcohol intake and different health outcomes. In conclusion, only a small proportion of observational studies in meta-analyses, referred to by several international alcohol guidelines, are funded by the alcohol industry. Based on this selection of observational studies the association between moderate alcohol consumption and different health outcomes does not seem to be related to funding source., (Copyright © The Author(s) on behalf of the American Society for Nutrition 2020.)

Diabetic foot ulcers are a common complication of diabetes, which affects 25% of patients and may ultimately lead to amputation of affected limbs. Research suggests hyperbaric oxygen therapy improves healing of these ulcers. However, this has not been reflected in previous reviews, possibly because they did not differentiate between patients with and without peripheral arterial occlusive disease. Therefore, we performed a systematic review of published literature in the MEDLINE, Embase, and Cochrane CENTRAL databases on nonischemic diabetic foot ulcers with outcome measures including complete ulcer healing, amputation rate (major and minor), and mortality. Seven studies were included, of which two were randomized clinical trials. Two studies found no difference in major amputation rate, whereas one large retrospective study found 2% more major amputations in the hyperbaric oxygen group. However, this study did not correct for baseline differences. Two studies showed no significant difference in minor amputation rate. Five studies reporting on complete wound healing showed no significant differences. In conclusion, the current evidence suggests that hyperbaric oxygen therapy does not accelerate wound healing and does not prevent major or minor amputations in patients with a diabetic foot ulcer without peripheral arterial occlusive disease. Based on the available evidence, routine clinical use of this therapy cannot be recommended. However, the available research for this specific subgroup of patients is scarce, and physicians should counsel patients on expected risks and benefits. Additional research, focusing especially on patient selection criteria, is needed to better identify patients that might profit from this therapy modality., (© 2019 The Authors. Wound Repair and Regeneration published by Wiley Periodicals, Inc. on behalf of by the Wound Healing Society.)

Background: Diabetic foot ulcers (DFUs) are frequently associated with peripheral arterial occlusive disease (PAOD) and may ultimately lead to amputations of the lower extremity. Adjuvant hyperbaric oxygen treatment (HBOT) might foster better wound healing and lower amputation rates in patients with DFU and PAOD. A systematic review was conducted to assess the effects of HBOT as an adjunctive therapy to standard treatment for patients with DFUs with PAOD., Methods: Systematic review using the MEDLINE, EMBASE, and Cochrane CENTRAL databases (from inception to October 2018). All original, comparative studies on the effect of HBOT on DFUs with PAOD were eligible. The primary outcome measures were amputation rate, amputation-free survival, complete ulcer healing, and mortality., Results: Eleven studies, totaling 729 patients, were included for analysis, including 7 randomized clinical trials, 2 controlled clinical trials, and 2 retrospective cohorts. Four were used for quantitative synthesis. Meta-analysis showed a significantly fewer major amputations in the HBOT group (10.7% vs 26.0%; risk difference, -15%; 95% confidence interval [CI], -25 to -6; P = .002; number needed to treat, 7; 95% CI, 4-20). No difference was found for minor amputations (risk difference, 8%; 95% CI, -13 to 30; P = .46). Three studies reporting on complete wound healing showed contrasting results. No significant difference was found for mortality or amputation-free survival., Conclusions: Current evidence shows that adjuvant HBOT improves major amputation rate, but not wound healing, in patients with DFUs and PAOD. Given the wide range of patients included in the trials, better patient selection may help define which patients with DFUs and PAOD benefit most from HBOT as standard adjunctive treatment., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Competency standards for clinical research professionals are being developed across the enterprise, based largely on the Core Competency Framework put forth by the Joint Task Force for Clinical Trial Competency (JTF). In late 2016, representatives from organizations around the world convened at a workshop hosted by the Multi-Regional Clinical Trial Center of Brigham and Women's Hospital and Harvard (MRCT Center) to discuss their use of the standards. A number of modifications were suggested that resulted in the publication of JTF Framework 2.0. Another suggested evolution of the Framework was to consider "leveling" the competencies, to reflect the increase in competency that occurs as individuals progress in their careers. This paper describes the process utilized and final outcome of this work. The leveled competencies, defined as the Fundamental, Skilled, and Advanced levels, and the included examples are expected to provide better-defined tools and resources to organizations that are creating educational and training programs, standardized role descriptions, or professional progression planning for clinical research professionals.

Background: Colorectal cancer is the third most common form of cancer and colorectal surgery is the treatment of choice in local disease. Anastomotic leakage following colorectal surgery is a major complication with a high incidence and mortality. Adjuvant hyperbaric oxygen treatment (HBOT) may be associated with reduction of anastomotic leakage. A systematic review was conducted regarding HBOT as an adjunctive therapy to colorectal surgery., Methods: Systematic review (1900-2017) using PubMed, Cochrane, EMBASE, Web of Science and EMCARE. All original published studies on the effect of HBOT as an adjunctive therapy for colorectal surgery with the creation of an anastomosis were considered., Results: Thirteen small animal trials were included for qualitative synthesis. We found no human trials. Eleven trials used bursting pressure whilst eight used hydroxyproline levels as a marker for collagen synthesis as primary outcome to assess the strength of the anastomosis. A meta-analysis performed for normal and ischaemic anastomoses showed that postoperative HBOT improves bursting pressure and hydroxyproline levels significantly in both normal (p ≤ 0.001 and p = 0.02) and ischaemic anastomoses (p ≤ 0.001 and p = 0.04)., Conclusion: Postoperative HBOT has a positive effect on colorectal anastomoses in rats. Further research should focus on a larger systematic animal study., (Copyright: This article is the copyright of the authors who grant Diving and Hyperbaric Medicine a non-exclusive licence to publish the article in electronic and other forms.)

Background: Many families rely on child care outside the home, making these settings important influences on child development. Nearly 1.5 million children in the U.S. spend time in family child care homes (FCCHs), where providers care for children in their own residences. There is some evidence that children in FCCHs are heavier than those cared for in centers. However, few interventions have targeted FCCHs for obesity prevention. This paper will describe the application of the Intervention Mapping (IM) framework to the development of a childhood obesity prevention intervention for FCCHs, Methods: Following the IM protocol, six steps were completed in the planning and development of an intervention targeting FCCHs: needs assessment, formulation of change objectives matrices, selection of theory-based methods and strategies, creation of intervention components and materials, adoption and implementation planning, and evaluation planning, Results: Application of the IM process resulted in the creation of the Keys to Healthy Family Child Care Homes program (Keys), which includes three modules: Healthy You, Healthy Home, and Healthy Business. Delivery of each module includes a workshop, educational binder and tool-kit resources, and four coaching contacts. Social Cognitive Theory and Self-Determination Theory helped guide development of change objective matrices, selection of behavior change strategies, and identification of outcome measures. The Keys program is currently being evaluated through a cluster-randomized controlled trial, Conclusions: The IM process, while time-consuming, enabled rigorous and systematic development of intervention components that are directly tied to behavior change theory and may increase the potential for behavior change within the FCCHs.

Background: Community-based interventions are promising approaches to obesity prevention, but few studies have prospectively evaluated them. The aim of this study was to evaluate a natural experiment—a community intervention designed to promote active living and decrease obesity within a small southern town., Methods: In 2011, community leaders implemented the Mebane on the Move intervention—a community-wide effort to promote physical activity (PA) and decrease obesity among residents of Mebane, North Carolina. We measured child PA and BMI before and after the intervention, using a nearby town not implementing an intervention as the comparison. In total, we assessed 64 children from Mebane and 40 from the comparison community 6 months before, as well as 34 and 18 children 6 months after the intervention. We assessed PA with accelerometers worn for 7 days and calculated BMI z-scores using children's height and weight. We conducted multivariable linear regressions examining pre- to postintervention change in minutes of PA and BMI z-score, adjusting for confounders., Results: At follow-up, children in Mebane modestly increased their moderate-to-vigorous PA (1.3 minutes per hour; 95% confidence interval (CI): 0.2, 2.3; p=0.03) and vigorous activity (0.8 minutes per hour; 95% CI: 0.1, 1.5; p=0.04) more than comparison children. In intervention children, BMI z-scores decreased 0.5 units (kg/m(2); 95% CI: -0.9, -0.02; p=0.045), compared to children in the comparison community., Conclusions: We observed positive effects on PA level and weight status of children in Mebane, despite high rates of attrition, suggesting that the community-based intervention may have been successful.

Background: This study examined whether objective measures of food, physical activity and built environment exposures, in home and non-home settings, contribute to children's body weight. Further, comparing GPS and GIS measures of environmental exposures along routes to and from school, we tested for evidence of selective daily mobility bias when using GPS data., Methods: This study is a cross-sectional analysis, using objective assessments of body weight in relation to multiple environmental exposures. Data presented are from a sample of 94 school-aged children, aged 5-11 years. Children's heights and weights were measured by trained researchers, and used to calculate BMI z-scores. Participants wore a GPS device for one full week. Environmental exposures were estimated within home and school neighbourhoods, and along GIS (modelled) and GPS (actual) routes from home to school. We directly compared associations between BMI and GIS-modelled versus GPS-derived environmental exposures. The study was conducted in Mebane and Mount Airy, North Carolina, USA, in 2011., Results: In adjusted regression models, greater school walkability was associated with significantly lower mean BMI. Greater home walkability was associated with increased BMI, as was greater school access to green space. Adjusted associations between BMI and route exposure characteristics were null. The use of GPS-actual route exposures did not appear to confound associations between environmental exposures and BMI in this sample., Conclusions: This study found few associations between environmental exposures in home, school and commuting domains and body weight in children. However, walkability of the school neighbourhood may be important. Of the other significant associations observed, some were in unexpected directions. Importantly, we found no evidence of selective daily mobility bias in this sample, although our study design is in need of replication in a free-living adult sample.

Objective: To present the short-term follow-up findings of the Steps to Health study, a randomized trial to evaluate the effectiveness of two employee weight management programs offered within Duke University and the Health System., Methods: A total of 550 obese (body mass index, ≥30 kg/m2) employees were randomized 1:1 between January 2011 and June 2012 to the education-based Weight Management (WM) or the WM+ arm, which focused on behavior modification. Employees were contacted to complete a follow-up visit approximately 14 months after baseline., Results: There were no clinically, or statistically, meaningful differences between arms, but there were modest reductions in body mass index, and positive, meaningful changes in diet and physical activity for both arms., Conclusions: The modest positive effects observed in this study may suggest that to achieve weight loss through the workplace more intensive interventions may be required.

Background: Young children's physical activity (PA) is influenced by their child care environment. This study assessed PA practices in centers from Massachusetts (MA) and Rhode Island (RI), compared them to best practice recommendations, and assessed differences between states and center profit status. We also assessed weather-related practices., Methods: Sixty percent of MA and 54% of RI directors returned a survey, for a total of 254. Recommendations were 1) daily outdoor play, 2) providing outdoor play area, 3) limiting fixed play structures, 4) variety of portable play equipment, and 5) providing indoor play area. We fit multivariable linear regression models to examine adjusted associations between state, profit status, PA, and weather-related practices., Results: MA did not differ from RI in meeting PA recommendations (β = 0.03; 0.15, 0.21; P = .72), but MA centers scored higher on weather-related practices (β = 0.47; 0.16, 0.79; P = .004). For-profit centers had lower PA scores compared with nonprofits (β = -0.20; 95% CI: -0.38, -0.02; P = .03), but they did not differ for weather (β = 0.12; -0.19, 0.44; P = .44)., Conclusions: More MA centers allowed children outside in light rain or snow. For-profit centers had more equipment—both fixed and portable. Results from this study may help inform interventions to increase PA in children.