Evidence related to a vegetarian diet and metabolic dysfunction-associated steatotic liver disease: protocol for a scoping review.

INTRODUCTION: Metabolic dysfunction-associated fatty liver disease (MASLD) is the hepatic manifestation of metabolic syndrome and the leading cause of chronic liver disease worldwide. Given that there is no pharmacological treatment for MASLD, it is imperative to understand whether lifestyle modifications may improve biochemical and pathological outcomes. One commonly proposed dietary modification is the Mediterranean diet; however, vegetarianism may also be a promising intervention. Vegetarianism has been shown to be associated with reduced morbidity and mortality in metabolic syndrome outcomes in coronary artery disease and diabetes; however, the relationship between vegetarian diet and MASLD is less clear. In this scoping review, we will provide a comprehensive overview of the current body of evidence related to a vegetarian diet and MASLD. METHODS AND ANALYSIS: The aim of this scoping review is to describe and summarise the current body of evidence related to MASLD and a vegetarian diet. This review will be conducted using Arksey and O'Malley's framework. The literature review will be conducted using the following databases: SCOPUS, Web of Science, CINAHL-Plus, Cochrane Library and Medline. No restriction will be made on publication date. Included studies will encompass clinical trials and observational designs that examine effects or association of vegetarian diet in adults (≥16 years) and report on the incidence, prevalence or progression of MASLD. Grey literature, non-human studies and articles focusing on changes in a specific food or nutraceutical will be excluded. Articles must have an English-language abstract available to be considered for inclusion. Screening and data extraction will be conducted by two independent reviewers. The findings will be summarised with descriptive statistics. ETHICS AND DISSEMINATION: Approval from a medical ethics committee is not required for this review. Once the review is complete, the findings will be submitted to a peer-reviewed journal.

NutriSup-PPN: A pilot randomized control trial of oral nutritional supplementation (ONS) and peripheral parenteral nutrition (PPN) in canadian, malnourished, hospitalized patients.

BACKGROUND & AIMS: Hospitalized malnourished patients experience poor outcomes. Our study determined the feasibility of a novel nutritional care pathway which both rapidly identifies and treats malnourished medical inpatients accounting for the obstacles in nutritional optimization. In our interventional arm, we utilize peripheral parental nutrition (PPN) followed by oral nutritional supplementation (ONS) on a composite outcome of 30 day readmission, mortality and continued admission, as well other important clinical and nutritional outcomes. The study was registered under ClinicalTrials.gov Identifier no. NCT02632630. METHODS: NutriSUP-PPN was a 2 × 2 factorial pilot randomized trial. In two large Canadian hospitals, we recruited 100 adult patients >18 years, < 48 h from admission to a general medicine ward who were moderately or severely malnourished. Patients received: 1. PPN for 5 days and then enhanced ONS until 30 days post randomization; 2. PPN for 5 days and then standard ONS until 30 days; 3. Standard care for intravenous (IV) fluid administration for 5 days and then enhanced ONS until 30 days; 4. Standard care for IV fluid administration for 5 days and standard ONS until 30 days. Our primary outcome was a composite of 30 day readmission, continued admission and mortality. RESULTS: There was no significant differences in the composite outcome of 30 day readmission, continued admission or mortality between any interventional group and control. We did however note a trend in the PPN + ONS arm where only 4/22 patients versus 10/24 patients (p = 0.16) in the control (no PPN, no enhanced ONS) experienced an adverse outcome which was largely driven by a reduction of readmission in the ONS + PPN arm We demonstrated feasibility in recruitment, adherence to protocol, and safety. The incidence of sepsis was greater in the PPN arm compared to control (15.5% versus 4.2%) but was not statistically significant. Improvement in nutritional status for interventional arms were not significant compared to control. However, there was a trend of improvement in preventing decline of nutritional status in both the enhanced ONS arm and PPN + enhanced ONS arm. CONCLUSION: There are signals in our data, which suggest that the combination of PPN with ONS may improve both clinical and nutritional outcomes compared to PPN or ONS alone. We posit that a large, multi-center, definitive randomized control trial is now justified to determine if PPN for up to 5 days along with 30 days of ONS, versus standard of care, will improve a composite outcome of death, continued admission, and readmission at 30 days. However, because PPN was associated with a non-statistically significant increase in episodes of sepsis, future studies should ensure that sepsis episodes are well documented and monitored closely by the data safety monitoring board.

Associations of long chain polyunsaturated fatty acids with bone mineral density and bone turnover in postmenopausal women.

PURPOSE: The immunomodulatory properties of n-3 long chain polyunsaturated fatty acids (LCPUFA) are reported to reduce bone loss through alteration of bone remodelling and n-3 LCPUFA, therefore, may benefit bone health in post-menopausal women, a vulnerable group at high risk of osteoporosis. METHODS: Measures of bone mineral density (BMD) were determined using dual energy X-ray absorptiometry (DEXA) in 300 post-menopausal women. The bone turnover markers osteocalcin (OC), C-terminal telopeptides of type 1 collagen (CTX) and total alkaline phosphatase were quantified in serum along with urinary creatinine corrected deoxypyridinoline (DPD/Cr) and CTX/Cr and the CTX:OC ratio calculated. Total serum n-6 PUFA (LA + AA) and n - 3 LCPUFA (ALA + EPA + DPA + DHA) were measured and the n - 6:n - 3 ratio was calculated. RESULTS: Mean (SD) age and body mass index (BMI) were 61 (6.4) years and 27.4 (4.8) kg/m2, respectively with participants being 12.6 (7.6) years post-menopause. Multiple regression analysis identified no association between n-3 LCPUFA and any of the measures of T-score or BMD albeit a significant positive association between total n - 3 LCPUFA and femur BMD (ß = 0.287; p = 0.043) was observed within those women with a low n - 6:n - 3 ratio. There was a significant inverse association between ALA and urinary DPD/Cr (ß = - 0.141; p = 0.016). CONCLUSION: A favourable low n - 6:n - 3 ratio was associated with higher femur BMD and a higher n - 3 LCPUFA (ALA) was associated with lower bone resorption. These results support a beneficial role for n - 3 LCPUFA in reducing postmenopausal bone resorption and favourably influencing BMD. TRIAL NUMBER & DATE OF REGISTRATION: ISRCTN63118444, 2nd October 2009, "Retrospectively registered".

Vitamin D deficiency in nursing home residents: a systematic review.

CONTEXT: Vitamin D deficiency is a global public health issue, particularly in nursing home residents. OBJECTIVE: This review critically summarizes the prevalence of vitamin D deficiency in nursing home residents worldwide. In addition, it outlines the effect of vitamin D intervention, alone or in combination with other nutrients or therapies, on improving vitamin D status and associated health outcomes in nursing home residents. DATA SOURCES, EXTRACTION, AND ANALYSIS: Searches were conducted of electronic databases for articles published from 2010 to May 2021. After screening of the 366 papers initially identified, 58 articles were included. CONCLUSIONS: A paucity of observational studies in nursing homes suggests a high prevalence of vitamin D deficiency ranging from 8% [25(OH)D <25 nmol/L], up to 94% [25(OH)D <50 nmol/L] in some cohorts where supplement use was low. Reported factors associated with deficiency and suboptimal vitamin D status include lack of sunlight exposure, poor dietary intake of vitamin D, limited vitamin D food fortification, frailty, poor renal function, and low use of vitamin D supplements. Residents who are severely deficient, deficient, or insufficient in vitamin D require remedial vitamin D supplementation prior to maintenance supplementation at doses >800 IU/day. High-dose vitamin D supplementation may reduce respiratory illness; however, supportive data are limited. Oral nutritional supplements, in combination with exercise, may benefit physical function and performance, whereas supplementation with vitamin D- and calcium-fortified foods has been associated with improved quality of life and reduced bone resorption. Globally, vitamin D deficiency is highly prevalent in nursing home residents. There is an urgent need for standardized dietary and supplementation guidelines to prevent deficiency in this vulnerable group.

Pain Reduction With AbobotulinumtoxinA for the Treatment of Hallux Valgus in Adult Participants: Results of a Randomized and Placebo-Controlled Phase 2 Trial.

AbobotulinumtoxinA (aboBoNT-A, Dysport® [Ipsen, Paris, France]) inhibits acetylcholine release at the neuromuscular junction and may modulate pain signaling in hallux valgus (HV). This randomized study (NCT03569098) included a double-blind phase (aboBoNT-A 300U, 500U or placebo injections into forefoot muscles) and an open-label aboBoNT-A treatment period in participants with an HV diagnosis and no HV surgery. The primary endpoint was change from baseline in numeric pain rating scale (NPRS) score at week 8. Secondary endpoints included change in NPRS (other time points) and proportion of participants with ≥20% reduction from baseline NPRS (responders). Post-hoc analyses assessed number of days in a 7-day evaluation period that participants spent in a lower pain state than at baseline. Participants received aboBoNT-A 300U (n = 63), 500U (n = 60) or placebo (n = 63). Superiority to placebo was not observed with either aboBoNT-A dose at week 8, thus the primary endpoint was unmet. At week 12, a trend toward efficacy was observed with aboBoNT-A 500U versus placebo and the proportion of participants with ≥20% reduction from baseline NPRS was greater with aboBoNT-A 500U versus placebo (p = .006). Participants in the aboBoNT-A 500U group spent more days with lower NPRS than their lowest baseline score, and with NPRS ≥2 points lower than their mean baseline NPRS at weeks 8 and 12 versus placebo (all p < .05; post-hoc). AboBoNT-A was well tolerated. Although the primary endpoint was unmet, other endpoints showed a nominal advantage for aboBoNT versus placebo for treatment of HV-related pain, particularly at week 12. Further clinical evaluation is needed to establish whether botulinum toxins represent a viable non-operative treatment option for HV-associated pain. PLAIN LANGUAGE SUMMARY: Hallux valgus is the medical name for a bunion, a foot deformity that can worsen over time. Patients with bunions experience pain and walking can become difficult, which can affect their quality of life. Foot support aids (e.g., braces, splints and inserts) are available, but surgery is the standard treatment. This study looked at how injections of a specific type of botulinum toxin, called abobotulinumtoxinA or "aboBoNT-A", into the foot may help to reduce pain in patients with bunions. The study included 186 patients aged 18 to 75 years who had not had surgery on their bunion. The researchers looked at how well the injections worked using scales that measure the pain levels the patient experienced. The main outcome was whether patients who had aboBoNT-A injections had less pain after 8 weeks than they did before treatment. The study included patients who were injected with saltwater (no treatment) to check that any treatment effect was real. Researchers also looked at the results after 12 weeks, as well as how many patients had less pain after treatment than before and how many days in a given week patients experienced less pain after treatment than they did before. There was no reduction in pain levels with aboBoNT-A injections after 8 weeks compared with no treatment. However, the other study outcomes suggested that aboBoNT-A resulted in a small benefit compared with no treatment, especially after 12 weeks. Further medical research is needed to establish whether botulinum toxins represent an alternative treatment to surgery for the pain associated with bunions.

Comment on Chao, H.-C. Zinc Deficiency and Therapeutic Value of Zinc Supplementation in Pediatric Gastrointestinal Diseases. Nutrients 2023, 15, 4093.

We appreciate the recent review article by Chao H.-C. [...].

Cost-effectiveness of vitamin D3 supplementation in older adults with vitamin D deficiency in Ireland.

Background: This study investigated the cost-effectiveness of vitamin D3 supplementation in older adults in Ireland, with year-round vitamin D deficiency (serum 25-hydroxyvitamin D concentration <30 nmol/L) (13% of Irish adults), from the perspective of the Health Service Executive. Methods: Three age groups were investigated: (1) ≥50 years, (2) ≥60 years and (3) ≥70 years. Based on the clinical literature, vitamin D3 supplementation may: (1) decrease all-cause mortality by 7% and (2) reduce hip fractures by 16% and non-hip fractures by 20%. A discount rate of 4% was applied to life years and quality-adjusted life years (QALYs) gained, and healthcare costs. The annual healthcare costs per patient used in the model are based on the average annual health resource use over the 5-year time horizon of the model. Results: The cost/QALY estimates in all three age groups are below the usually acceptable cost-effectiveness threshold of €20 000/QALY. The most cost-effective and least costly intervention was in adults ≥70 years. For this age group, the average annual costs and outcomes would be approximately €5.6 million, 1044 QALYs gained, with a cost/QALY of approximately €5400. The results are most sensitive to the mortality risk reduction following vitamin D3 supplementation. Conclusion: The cost-effectiveness of vitamin D3 supplementation is most robust in adults ≥70 years. Clinical uncertainty in the magnitude of the benefits of vitamin D3 supplementation could be further addressed by means of: (1) performing a clinical research study or (2) conducting a pilot/regional study, prior to reaching a decision to invest in a nationwide programme.

Vitamin D and Bone Health of Older Adults within Care Homes: An Observational Study.

Limited studies have reported vitamin D status and health outcomes in care home residents, a group at risk of vitamin D deficiency. This study investigated serum 25-hydroxyvitamin D (25-OHD) concentrations in older adults within care homes in Northern Ireland (NI) and its association with musculoskeletal health (ultrasound T-score, muscle strength, Timed Up & Go test (TUG)), bone turnover markers (BTMs), and immune function markers. A total of 87 participants were recruited with mean ± SD age 83.2 ± 7.9 years. Mean ± SD serum 25-OHD concentration (n 69) was 49.52 ± 35.58 nmol/L. Vitamin D deficiency (25-OHD <25 nmol/L) was observed in 34.8% (n 24) of participants with 17.4% (n 12) classified as insufficient (25-OHD 25−50 nmol/L) and 47.8% (n 33) as sufficient (25-OHD >50 nmol/L). 25-OHD concentration was not an independent predictor of T-score, muscle strength, TUG, or inflammatory cytokines. After adjusting for covariates, a significant negative association was observed between 25-OHD concentration and the BTMs; osteocalcin (ß = −0.395; p = 0.001), procollagen type 1 N propeptide (P1NP) (ß = −0.320; p = 0.012), and C-terminal telopeptide of type 1 collagen (CTX) (ß = −0.377; p = 0.003). Higher 25-OHD concentration was positively associated with use of vitamin D ± calcium supplementation (ß = 0.610; p < 0.001). Vitamin D deficiency and insufficiency were highly prevalent in this sample of care home residents in NI. Higher 25-OHD concentration was associated with greater supplement use and with reduced bone turnover, which in this population is linked with reduced bone loss. These findings emphasize the need for a mandatory vitamin D ± calcium supplementation policy specific for care home residents.

Knowledge gaps in the management of refractory reflux-like symptoms: Healthcare provider survey.

BACKGROUND: Refractory reflux-like symptoms have a substantial impact on patients and healthcare providers. The aim of the survey was to qualitatively assess the needs and attitudes of practicing clinicians around the management of refractory reflux symptoms and refractory gastroesophageal reflux disease (rGERD). METHODS: An International Working Group for the Classification of Oesophagitis (IWGCO) steering committee invited clinicians to complete an online survey including 17 questions. KEY RESULTS: Of the 113 clinicians who completed the survey, 70% were GIs, 20% were primary care physicians, and 10% were other specialties. Functional heartburn was considered the most common reason for an incomplete response to proton pump inhibitor (PPI) therapy (82%), followed by stress/anxiety (69%). More GIs identified esophageal hypersensitivity as a cause, while more non-GIs identified esophageal dysmotility and non-reflux-related esophageal conditions. As the first step, most clinicians would order investigations (70-88%). Overall, 72% would add supplemental therapy for patients with partial response, but only 58% for those with non-response. Antacid/alginate was the most common choice overall, while non-GIs were more likely to add a prokinetic than were GIs (47.8 vs. 24.1%). Approximately 40% of clinicians would switch PPIs in patients with partial response, but only 29% would do so in non-responders. Preferences for long-term therapy were highly variable. The most common initial investigation was upper endoscopy. Choice of esophageal manometry and pH monitoring was more variable, with no clear preference for whether pH monitoring should be conducted on, or off, PPI therapy. CONCLUSIONS AND INFERENCES: The survey identified a number of challenges for clinicians, especially non-GI physicians, treating patients with refractory reflux-like symptoms or rGERD on a daily basis.

Effect of Ion Irradiation on Nanoindentation Fracture and Deformation in Silicon Carbide.

Silicon carbide is desirable for many nuclear applications, making it necessary to understand how it deforms after irradiation. Ion implantation combined with nanoindentation is commonly used to measure radiation-induced changes to mechanical properties; hardness and modulus can be calculated from load-displacement curves, and fracture toughness can be estimated from surface crack lengths. Further insight into indentation deformation and fracture is required to understand the observed changes to mechanical properties caused by irradiation. This paper investigates indentation deformation using high-resolution electron backscatter diffraction (HR-EBSD) and Raman spectroscopy. Significant differences exist after irradiation: fracture is suppressed by swelling-induced compressive residual stresses, and the plastically deformed region extends further from the indentation. During focused ion beam cross-sectioning, indentation cracks grow, and residual stresses are modified. The results clarify the mechanisms responsible for the modification of apparent hardness and apparent indentation toughness values caused by the compressive residual stresses in ion-implanted specimens. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11837-021-04636-8.

Home parenteral nutrition patients on mixed oil lipid emulsion have a higher rate of hospitalizations compare to those on soybean oil- a prospective 2-year cohort study.

BACKGROUND & AIMS: Mixed oil intravenous lipid emulsion (MO ILE) that contains 30% soybean oil (SO), 30% medium chain triglycerides, 25% olive oil and 15% fish oil can benefit hospitalized patients receiving parenteral nutrition (PN) but there are very few studies on its long-term use. Our goal was to evaluate the clinical outcomes of adults receiving home PN (HPN) with MO versus those receiving SO ILE over a 2-year period. METHOD: This is a retrospective analysis of data collected prospectively from a cohort of patients recorded in the Canadian HPN Registry over a 2-year period. HPN patients from academic programs across Canada were entered in the Registry according to a validated protocol. For this study, demographic, nutritional, laboratory and clinical data were extracted from January 1st 2015, when MO lipid emulsion became available in Canada, to July 24th 2019. Clinical data for each patient included: number of hospitalizations, number of hospitalizations related to HPN and number of hospitalization days related to HPN, over a year; incidence of line sepsis per 1000 catheter days and mortality. Data are presented as median (1st, 3rd quartile) for continuous variables and frequency (percentage) for categorical variables. Comparisons between groups were performed using two sample t-test or Wilcoxon Rank Sum tests for continuous variables and Chi-square tests or Fisher's exact tests for categorical variables. Univariate and multiple linear regressions were also carried out. Statistical significance is set at a p-value <0.05. RESULTS: A total of 120 patients were included (MO n = 68, SO n = 52). Significant differences at baseline between the two groups were a higher use of Hickman line (62.12% vs 42%, p = 0.038) and more western Canada based hospital care with MO (75% vs 42.31%, p = 0.0002). The MO group had significantly more hospitalizations (p = 0.001), more hospitalizations related to HPN (p = 0.012) and more hospitalization days related to HPN (p = 0.016) per patient per year compared to SO patients. There was no significant difference between groups for line sepsis per 1000 catheter days (MO: 0.05 (0.0, 1.0) vs SO: 0.0 (0.0, 0.22), p = 0.053) or mortality. All other variables, including biochemical variables, were similar between groups. In a multiple regression analysis, the following factors were significantly associated with a greater number of hospitalizations per patient per year: use of MO, high blood glucose from the last recorded value and having died by the end of the study period. CONCLUSION: This 2-year prospective cohort study suggests an increased risk of hospitalization in HPN patients receiving MO lipid emulsion. The long-term effect of using MO lipid emulsion in HPN patients should be further evaluated using a large randomized controlled trial. THE STUDY WAS REGISTERED IN CLINICALTRIALS.GOV: (NCT02299466).

Molecular Biomarkers of Oxygen Therapy in Patients with Diabetic Foot Ulcers.

Hyperbaric oxygen therapy (HBOT) and topical oxygen therapy (TOT) including continuous diffuse oxygen therapy (CDOT) are often utilized to enhance wound healing in patients with diabetic foot ulcerations. High pressure pure oxygen assists in the oxygenation of hypoxic wounds to increase perfusion. Although oxygen therapy provides wound healing benefits to some patients with diabetic foot ulcers, it is currently performed from clinical examination and imaging. Data suggest that oxygen therapy promotes wound healing via angiogenesis, the creation of new blood vessels. Molecular biomarkers relating to tissue inflammation, repair, and healing have been identified. Predictive biomarkers can be used to identify patients who will most likely benefit from this specialized treatment. In diabetic foot ulcerations, specifically, certain biomarkers have been linked to factors involving angiogenesis and inflammation, two crucial aspects of wound healing. In this review, the mechanism of how oxygen works in wound healing on a physiological basis, such as cell metabolism and growth factor signaling transduction is detailed. Additionally, observable clinical outcomes such as collagen formation, angiogenesis, respiratory burst and cell proliferation are described. The scientific evidence for the impact of oxygen on biomolecular pathways and its relationship to the outcomes in clinical research is discussed in this narrative review.

Wound Bed Preparation 2021.

GENERAL PURPOSE: To present the 2021 update of the Wound Bed Preparation paradigm. TARGET AUDIENCE: This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care. LEARNING OBJECTIVES/OUTCOMES: After participating in this educational activity, the participant will: 1. Apply wound assessment strategies. 2. Identify patient concerns about wound care. 3. Select management options for healable, nonhealable, and maintenance wounds.

Wound Bed Preparation is a paradigm to optimize chronic wound treatment. This holistic approach examines the treatment of the cause and patient-centered concerns to determine if a wound is healable, a maintenance wound, or nonhealable (palliative). For healable wounds (with adequate blood supply and a cause that can be corrected), moisture balance is indicated along with active debridement and control of local infection or abnormal inflammation. In maintenance and nonhealable wounds, the emphasis changes to patient comfort, relieving pain, controlling odor, preventing infection by decreasing bacteria on the wound surface, conservative debridement of slough, and moisture management including exudate control. In this fourth revision, the authors have reformulated the model into 10 statements. This article will focus on the literature in the last 5 years or new interpretations of older literature. This process is designed to facilitate knowledge translation in the clinical setting and improve patient outcomes at a lower cost to the healthcare system.

The Potential Role of Sensors, Wearables and Telehealth in the Remote Management of Diabetes-Related Foot Disease.

Diabetes-related foot disease (DFD), which includes foot ulcers, infection and gangrene, is a leading cause of the global disability burden. About half of people who develop DFD experience a recurrence within one year. Long-term medical management to reduce the risk of recurrence is therefore important to reduce the global DFD burden. This review describes research assessing the value of sensors, wearables and telehealth in preventing DFD. Sensors and wearables have been developed to monitor foot temperature, plantar pressures, glucose, blood pressure and lipids. The monitoring of these risk factors along with telehealth consultations has promise as a method for remotely managing people who are at risk of DFD. This approach can potentially avoid or reduce the need for face-to-face consultations. Home foot temperature monitoring, continuous glucose monitoring and telehealth consultations are the approaches for which the most highly developed and user-friendly technology has been developed. A number of clinical studies in people at risk of DFD have demonstrated benefits when using one of these remote monitoring methods. Further development and evidence are needed for some of the other approaches, such as home plantar pressure and footwear adherence monitoring. As yet, no composite remote management program incorporating remote monitoring and the management of all the key risk factors for DFD has been developed and implemented. Further research assessing the feasibility and value of combining these remote monitoring approaches as a holistic way of preventing DFD is needed.

Is Reconstruction of Unstable Midfoot Charcot Neuroarthropathy Cost Effective from a US Payer's Perspective?

BACKGROUND: Charcot neuroarthropathy is a morbid and expensive complication of diabetes that can lead to lower extremity amputation. Current treatment of unstable midfoot deformity includes lifetime limb bracing, primary transtibial amputation, or surgical reconstruction of the deformity. In the absence of a widely adopted treatment algorithm, the decision to pursue more costly attempts at reconstruction in the United States continues to be driven by surgeon preference. QUESTIONS/PURPOSES: To examine the cost effectiveness (defined by lifetime costs, quality-adjusted life-years [QALYs] and incremental cost-effectiveness ratio [ICER]) of surgical reconstruction and its alternatives (primary transtibial amputation and lifetime bracing) for adults with diabetes and unstable midfoot Charcot neuroarthropathy using previously published cost data. METHODS: A Markov model was used to compare Charcot reconstruction and its alternatives in three progressively worsening clinical scenarios: no foot ulcer, uncomplicated (or uninfected) ulcer, and infected ulcer. Our base case scenario was a 50-year-old adult with diabetes and unstable midfoot deformity. Patients were placed into health states based on their disease stage. Transitions between health states occurred annually using probabilities estimated from the evidence obtained after systematic review. The time horizon was 50 cycles. Data regarding costs were obtained from a systematic review. Costs were converted to 2019 USD using the Consumer Price Index. The primary outcomes included the long-term costs and QALYs, which were combined to form ICERs. Willingness-to-pay was set at USD 100,000/QALY. Multiple sensitivity analyses and probabilistic analyses were performed to measure model uncertainty. RESULTS: The most effective strategy for patients without foot ulcers was Charcot reconstruction, which resulted in an additional 1.63 QALYs gained and an ICER of USD 14,340 per QALY gained compared with lifetime bracing. Reconstruction was also the most effective strategy for patients with uninfected foot ulcers, resulting in an additional 1.04 QALYs gained, and an ICER of USD 26,220 per QALY gained compared with bracing. On the other hand, bracing was cost effective in all scenarios and was the only cost-effective strategy for patents with infected foot ulcers; it resulted in 6.32 QALYs gained and an ICER of USD 15,010 per QALY gained compared with transtibial amputation. As unstable midfoot Charcot neuroarthropathy progressed to deep infection, reconstruction lost its value (ICER USD 193,240 per QALY gained) compared with bracing. This was driven by the increasing costs associated with staged surgeries, combined with a higher frequency of complications and shorter patient life expectancies in the infected ulcer cohort. The findings in the no ulcer and uncomplicated ulcer cohorts were both unchanged after multiple sensitivity analyses; however, threshold effects were identified in the infected ulcer cohort during the sensitivity analysis. When the cost of surgery dropped below USD 40,000 or the frequency of postoperative complications dropped below 50%, surgical reconstruction became cost effective. CONCLUSIONS: Surgeons aiming to offer both clinically effective and cost-effective care would do well to discuss surgical reconstruction early with patients who have unstable midfoot Charcot neuroarthropathy, and they should favor lifetime bracing only after deep infection develops. Future clinical studies should focus on methods of minimizing surgical complications and/or reducing operative costs in patients with infected foot ulcers. LEVEL OF EVIDENCE: Level II, economic and decision analysis.

Getting fit for hip and knee replacement: a protocol for the Fit-Joints pilot randomized controlled trial of a multi-modal intervention in frail patients with osteoarthritis.

BACKGROUND: Joint replacement provides significant improvements in pain, physical function, and quality of life in patients with osteoarthritis. With a growing body of evidence indicating that frailty can be treated, it is important to determine whether targeting frailty reduction in hip and knee replacement patients improves post-operative outcomes. OBJECTIVES: The primary objective is to examine the feasibility of a parallel group RCT comparing a preoperative multi-modal frailty intervention to usual care in pre-frail/frail older adults undergoing elective unilateral hip or knee replacements. The secondary objectives areTo explore potential efficacy of the multi-modal frailty intervention in improving frailty and mobility between baseline and 6 weeks post-surgery using Fried frailty phenotype and short performance physical battery (SPPB) respectively.To explore potential efficacy of the multi-modal frailty intervention on post-operative healthcare services use. METHODS/DESIGN: In a parallel group pilot RCT, participants will be recruited from the Regional Joint Assessment Program in Hamilton, Canada. Participants who are (1) ≥ 60 years old; (2) pre-frail (score of 1 or 2) or frail (score of 3-5; Fried frailty phenotype); (3) having elective unilateral hip or knee replacement; and (4) having surgery wait times between 3 and 10 months will be recruited and randomized to either the intervention or usual care group. The multi-modal frailty intervention components will include (1) tailored exercise program (center-based and/or home-based) with education and cognitive behavioral change strategies; (2) protein supplementation; (3) vitamin D supplementation; and (4) medication review. The main comparative analysis will take place at 6 weeks post-operative. The outcome assessors, data entry personnel, and data analysts are blinded to treatment allocation. Assessments: feasibility will be assessed by recruitment rate, retention rate, and data collection completion. Frailty and healthcare use and other clinical outcomes will be assessed. The study outcomes will be collected at the baseline, 1 week pre-operative, and 6 weeks and 6 months post-operative. DISCUSSION: This is the first study to examine the feasibility of multi-modal frailty intervention in pre-frail/frail older adults undergoing hip or knee replacement. This study will inform the planning and designing of multi-modal frailty interventional studies in hip and knee replacement patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT02885337.

Externalizing Metaphors Therapy and Innovative Moments: A Four-Session Treatment Group for Anxiety.

The zeitgeist for brief services psychotherapy efficacy is well underway within the individual and family therapy treatment modalities. However, this paradigm shift, to produce clinically significant mental health outcomes in a much shorter time, has evolved to a much lesser degree within the treatment group format. Longer-term treatment group protocols typically do not match treatment-seeking behaviors with high dropout rates for clients. The current authors describe a structured, four-session treatment protocol that integrates the tenets of Externalizing Metaphors Therapy (EMT) with Innovative Moments (IMs) in addressing anxiety for children and youth. EMT is based upon the externalization of problems, transformation of metaphoric imagery, and the shifting of underlying maladaptive emotional schemas. It is suggested that treatment outcomes are enhanced through the integration of three IMs between-session exercises.

The Effectiveness of Calf Muscle Electrostimulation on Vascular Perfusion and Walking Capacity in Patients Living With Type 2 Diabetes Mellitus and Peripheral Artery Disease.

The aim of the study was to explore calf muscle electrostimulation on arterial inflow and walking capacity in claudicants with peripheral artery disease and diabetes mellitus. A prospective, 1-group, pretest-posttest study design was used on 40 high-risk participants (n = 40) who exhibited bilateral limb ischemia (ankle brachial pressure index [ABPI] <0.90), diabetes mellitus, and calf muscle claudication. A program of calf muscle electrical stimulation with varying frequency (1-250 Hz) was prescribed for 1 hour per day for 12 weeks. Spectral waveforms analysis, ABPI, absolute claudication distance (ACD), and thermographic temperature patterns across 4 specified regions of interest (hallux, medial forefoot, lateral forefoot, heel) at rest and after exercise, were recorded at baseline and following intervention to evaluate for therapeutic outcomes. A significant improvement in ACD and ABPI was registered following the intervention ( P = .000 and P = .001, respectively). Resting foot temperatures increased significantly ( P = .000) while the postexercise temperature drops were halved across all regions at follow-up, with hallux ( P = .005) and lateral forefoot ( P = .038) reaching statistical significance. Spectral Doppler waveforms were comparable ( P = .304) between both serial assessments. Electrical stimulation of varying frequency for 1 hour per day for 12 consecutive weeks registered statistically significant improvement in outcome measures that assess arterial inflow and walking capacity in claudicants with diabetes mellitus. These results favor the use of electrostimulation as a therapeutic measure in this high-risk population.

Using Plantar Electrical Stimulation to Improve Postural Balance and Plantar Sensation Among Patients With Diabetic Peripheral Neuropathy: A Randomized Double Blinded Study.

OBJECTIVE: People with diabetic peripheral neuropathy (DPN) often exhibit deteriorations in motor-performance mainly due to lack of plantar-sensation. The study explored effectiveness of plantar electrical-stimulation therapy to enhance motor-performance among people with DPN. DESIGN AND METHODS: Using a double-blinded model, 28 volunteers with DPN (age: 57.8 ± 10.2 years) were recruited and randomized to either intervention (IG: n = 17) or control (CG: n = 11) group. Both groups received identical plantar-stimulation devices for six weeks of daily use at home; however, only the IG devices were set to deliver stimulation. Balance (ankle, hip, and center of mass [COM] sway) and gait (stride velocity [SV], stride time [ST], stride length [SL], and cadence) were measured using validated wearable sensors. Outcomes were assessed at baseline and at six-week. Clinical assessment including vascular as measured by ankle-brachial-index (ABI) and plantar-sensation as quantified by vibratory plantar threshold (VPT) were also measured at baseline and six weeks. RESULTS: No difference were observed between groups for baseline characteristics ( P > .050). Posttherapy, ankle and COM sway with eyes open were significantly improved ( P < .05, Cohen's effect size d = 0.67-0.76) in the IG with no noticeable changes in CG. All gait parameters were significantly improved in the IG with highest effect size observed for cadence ( d = 1.35, P = .000). Results revealed improvement in VPT ( P = .004, d = 1.15) with significant correlation with stride velocity improvement ( r = .56, P = .037). ABI was improved in the IG in particulate among those with ABI>1.20 ( P = .041, d = 0.99) Conclusion: This study suggests that daily home use of plantar electrical-stimulation may be a practical means to enhance motor-performance and plantar-sensation in people with DPN.