Development of a Wound Assessment Tool for Use in Adults at End of Life: A Modified Delphi Study.

BACKGROUND: Some patients at end of life (EOL) develop wounds known as Kennedy terminal ulcers, terminal ulcers, and Skin Changes At Life's End. However, there is ambiguity around the defining wound characteristics of these conditions and a lack of validated clinical assessment tools available to identify them. OBJECTIVE: To gain consensus on the definition and characteristics of EOL wounds and establish the face and content validity of a wound assessment tool for use in adults at EOL. METHODS: Using a reactive online Delphi technique, international wound experts reviewed the 20 items in the tool. Over two iterative rounds, experts assessed item clarity, relevance, and importance using a four-point content validity index. The content validity index scores were calculated for each item, with a level of 0.78 or higher signifying panel consensus. RESULTS: Round 1 included 16 panelists (100.0%). The agreement for item relevance and importance ranged from 0.54% to 0.94%, and item clarity scored between 0.25% and 0.94%. Following round 1, four items were removed, and seven others reworded. Other suggestions included changing the tool name and including Kennedy terminal ulcer, terminal ulcer, and Skin Changes At Life's End in the EOL wound definition. In round 2, the now 13 panel members agreed with the final 16 items included and suggested minor wording changes. CONCLUSIONS: This tool could provide clinicians with an initially validated tool to accurately assess EOL wounds and gather much needed empirical prevalence data. Further research is needed to underpin accurate assessment and the development of evidence-based management strategies.

Incidence, Clinical Profile, and Management of Keratitis Caused by Uncommon Species of Pseudomonas at a Tertiary Eye Care Center.

PURPOSE: The purpose of this study was to study the incidence, demographic features, clinical course, profiling, and management of uncommon species of Pseudomonas keratitis (other than Pseudomonas aeruginosa ) at a tertiary eye care center. METHODS: Thirty cases of culture-proven uncommon species of Pseudomonas keratitis between January 2017 and December 2021 were retrospectively studied. The incidence, demographic and clinical profile, predisposing factors, microbial results, treatment, and visual outcomes were analyzed. We evaluated the risk factors for poor treatment outcomes. RESULTS: Among bacterial keratitis cases, uncommon species of Pseudomonas keratitis occurred at a rate of 2.2%. The mean age at presentation was 51.37 years, and the most common predisposing factor was corneal trauma (36.7%). The mean best corrected visual acuity (BCVA) [in log of minimum angle of resolution (logMAR)] at presentation was 1.99, and the mean ulcer size was 5.75 mm. On culture, 56.7% of the cases were identified as Pseudomonas putida , 26.7% as Pseudomonas stutzeri , 10% as Pseudomonas mendocina, and 3.3% each of Pseudomonas oryzihabitans and Pseudomonas alcaligenes . We recorded good treatment responses in 66.7% of cases with the medical therapy of a combination of broad-spectrum antibiotics, whereas 33.3% of cases required surgical intervention. The risk factors for poor clinical outcome were older age, ocular trauma, previous ocular surgeries, poor BCVA at presentation, large ulcer size, delayed treatment, hypopyon, and early complications such as perforation, limbal involvement, and total ulcer. CONCLUSIONS: Uncommon species of pseudomonas keratitis was more closely related to predisposing factors such as corneal trauma and other factors such as previous ocular surgeries, older age, large ulcers, longer duration of treatment, early surgical intervention in complicated cases, and poor visual outcome.

Cost of Treatment of Neuroischemic Ulcers of the Lower Extremity in Patients with Peripheral Artery Disease in the United States.

BACKGROUND: We evaluated the cost of treating neuroischemic ulcers of the lower extremity in patients with peripheral artery disease by using medical and hospital claims records submitted for reimbursement to payers (private insurance, Medicare, Medicaid). METHODS: Adjudicated claims and remittance data on claims that include submitted charges, line items paid by insurers directly to providers and patient payments of copays, deductibles and co-insurance were used. Eligible patients from a commercial database containing more than 60% of US patients with health insurance were analyzed. Patient selection, performed using International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes, yielded a study population of 42,837 unique anonymized patients. RESULTS: Using the metric of "submitted charges" to overcome differences in levels of reimbursement across insurance payers and Medicare/Medicaid, we identified 34,348 patients with ulcers with an average treatment cost of $94,100 per patient ($41,800 annualized) The costliest ulcer subtype was nonpressure ulcer of the heel/midfoot among 13,184 patients with $121,400 per patient ($53,900 annualized), 29% higher than across all ulcer types. The subset of 22,281 ulcer patients who also had a surgical procedure incurred costs of $121,000 per patient ($53,800 annualized). The costliest surgical codes were complications of vascular prosthetic devices, implants, grafts among 6444 patients with $146,900 per patient ($65,300 annualized). The combination of most expensive ulcer and most expensive surgery yielded a cohort of 2355 patients with the highest average cost of $177,400 per patient ($78,800 annualized). CONCLUSIONS: The resource burden for management of neuroischemic ulcers of the lower extremity in patients with peripheral artery disease is substantial. Mitigating this burden may help reduce significant resource utilization.

Correlation between magnetic resonance enterography and ileo-colonoscopy for assessment of disease activity in terminal ileal Crohn's disease.

BACKGROUND: Magnetic resonance enterography (MRE) has emerged as a novel tool for the assessment of disease activity in Crohn's disease (CD). Real world data from Indian subcontinent on performance of MRE in terminal ileal CD are lacking. METHODS: Retrospective analysis of patients with terminal ileal CD who underwent both ileo-colonoscopy and MRE was performed. Ileo-colonoscopy was considered the gold standard for assessment of disease activity. On ileo-colonoscopy, a simple endoscopic score for Crohn's disease (SES-CD) ≥2 was considered active disease; presence of ulcers indicated severe disease. MRE scoring of the disease activity was performed using magnetic resonance index of activity (MARIA) and simplified MARIA (MARIAs). The measure of agreement between ileo-colonoscopy and MRE and comparison of MARIA and MARIAs for assessment of disease activity and sensitivity of MRE to detect mucosal ulcerations were calculated. RESULTS: Seventy patients with terminal ileal CD (mean age 40.74±15.56 years; 71.4% males [n=50]) were evaluated. The sensitivities of MARIA and MARIAs scores to detect active disease were 0.76 and 0.84, respectively. The area under the receiver operating characteristic curve (AUROC) for detecting severe disease was 0.836 (p<0.0001) for MARIA and 0.861 (p<0.0001) for MARIAs. For mild active disease, there was no agreement between SES-CD and MARIA or MARIAs; however, for severe disease, the agreement was fair and moderate for MARIA and MARIAs, respectively. MARIA and MARIAs were comparable for identification of active and severe disease (κ 0.759, p<0.0001 and κ 0.840, p<0.0001, respectively). MRE was 68.18% sensitive to detect mucosal ulcers. CONCLUSION: MRE is a reliable and sensitive tool for detection of endoscopically severe, but not mild, terminal ileal CD.

Oral Bisphosphonates Are Associated With Increased Risk of Severe Acute Kidney Injury in Elderly Patients With Complex Health Needs: A Self-Controlled Case Series in the United Kingdom.

Although oral bisphosphonates (BP) are commonly used, there is conflicting evidence for their safety in the elderly. Safety concerns might trump BP use in older patients with complex health needs. Our study evaluated the safety of BP, focusing on severe acute kidney injury (AKI), gastrointestinal ulcer (GI ulcer), osteonecrosis of the jaw (ONJ), and femur fractures. We used UK primary care data (Clinical Practice Research Datalink [CPRD GOLD]), linked to hospital (Hospital Episode Statistics [HES] inpatient) and ONS mortality data. We included all patients aged >65 with complex health needs and no BP use in the year before study start (January 1, 2010). Complex health needs were defined in three cohorts: an electronic frailty index score ≥3 (frailty cohort), one or more unplanned hospitalization/s (hospitalization cohort); and prescription of ≥10 different medicines in 2009 (polypharmacy cohort). Incidence rates were calculated for all outcomes. Subsequently, all individuals who experienced AKI or GI ulcer anytime during follow-up were included for Self-Controlled Case Series (SCCS) analyses. Incidence rate ratios (IRRs) were estimated separately for AKI and GI ulcer, comparing event rates between BP-exposed and unexposed time windows. No SCCS were conducted for ONJ and femur fractures. We identified 94,364 individuals in the frailty cohort, as well as 78,184 and 95,621 persons in the hospitalization and polypharmacy cohorts. Of those, 3023, 1950, and 2992 individuals experienced AKI and 1403, 1019, and 1453 had GI ulcer/s during follow-up, respectively. Age-adjusted SCCS models found evidence of increased risk of AKI associated with BP use (frailty cohort: IRR 1.65; 95% confidence interval [CI], 1.25-2.19), but no association with GI ulcers (frailty cohort: IRR 1.24; 95% CI, 0.86-1.78). Similar results were obtained for the hospitalization and polypharmacy cohorts. Our study found a 50% to 65% increased risk of AKI associated with BP use in elderly patients with complex health needs. Future studies should further investigate the risk-benefit of BP use in these patients. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Economic and health impacts of Helicobacter pylori eradication strategy for the treatment of peptic ulcer disease: A cost-effectiveness analysis.

BACKGROUND: Most peptic ulcer cases are associated with Helicobacter pylori (H. pylori) infection or the use of nonsteroidal anti-inflammatory drugs (NSAIDs). H. pylori eradication therapy is recommended for the treatment of H. pylori-positive peptic ulcers. We aimed to assess and validate the cumulative economic and health effects of H. pylori eradication strategy for the treatment of peptic ulcers compared with PPI therapy strategy. MATERIALS AND METHODS: We developed a cohort state-transition model for H. pylori eradication strategy and PPI therapy strategy over a lifetime horizon from a healthcare payer perspective. We targeted two hypothetical cohorts of H. pylori-positive patients with gastric and duodenal ulcers aged 20, 30, 40, 50, 60, 70, and 80. The main outcomes were costs, quality-adjusted life-years (QALYs), life expectancy life-years (LYs), incremental cost-effectiveness ratios, ulcer recurrence cases, and ulcer-associated deaths. One-way and probabilistic sensitivity analyses were conducted to assess the impact of uncertainty. RESULTS: In the base-case analysis, H. pylori eradication strategy was less costly with greater benefits than PPI therapy strategy in all age groups. Cost-effectiveness was not sensitive to any variables in all age groups. Sensitivity analyses showed strong robustness of the results. From 2000 to 2020, H. pylori eradication strategy saved US$14.07 billion over a lifetime, increased 8.65 million QALYs and 1.23 million LYs over a lifetime, and prevented 551,298 ulcer recurrence cases and 59,465 ulcer-associated deaths, compared with PPI therapy strategy. CONCLUSIONS: H. pylori eradication strategy not only has contributed significantly to preventing ulcer recurrence and reducing ulcer-associated deaths but also has resulted in great cost savings. All over the world, H. pylori eradication strategy is likely to have yielded a comparable magnitude of economic and health benefits, depending on the epidemiology of H. pylori-related peptic ulcers and the healthcare environment in each country.

Sub-epidermal moisture assessment as an adjunct to visual assessment in the reduction of pressure ulcer incidence.

OBJECTIVE: To assess the effectiveness of sub-epidermal moisture (SEM) assessment technology as an adjunct to visual assessment to reduce pressure ulcer (PU) incidence alongside standard PU care pathways. METHOD: Data were obtained from wards located within 28 institutions in the UK, Canada, Belgium, Spain and Ireland. At each ward, the proportion of patients scanned who were observed to have one or more PUs of Category 2 or above during a pre-Pressure Ulcer Reduction Programme (PURP) implementation period starting between November 2017 and July 2018 was recorded. The proportion of patients scanned who were observed to have one or more PUs of Category 2 or above during a post-PURP implementation period starting between November 2018 and July 2019 was also recorded. A meta-analysis was conducted on the data using wards as the unit of analysis, to facilitate overall estimate of the PURP. A sensitivity study was also conducted to assess the sensitivity of results to data from specific institutions. RESULTS: A synthesised estimate of the overall relative risk (RR) was calculated to be 0.38 (95% confidence interval 0.26 to 0.56). Hence the risk of PU in the post-PURP cohort was about one-third that of the corresponding risk in the pre-PURP cohort. The sensitivity analysis revealed no evidence that any individual ward exerted excessive influence on the findings. CONCLUSION: The analysis has revealed strong evidence that implementation of the PURP was associated with reduction in incidence of Category 2 or above PUs across a wide range of clinical settings.

Cost-effectiveness of dehydrated human amnion/chorion membrane allografts in lower extremity diabetic ulcer treatment.

OBJECTIVE: To evaluate the cost-effectiveness and budget impact of using standard care (no advanced treatment, NAT) compared with an advanced treatment (AT), dehydrated human amnion/chorion membrane (DHACM), when following parameters for use (FPFU) in treating lower extremity diabetic ulcers (LEDUs). METHOD: We analysed a retrospective cohort of Medicare patients (2015-2019) to generate four propensity-matched cohorts of LEDU episodes. Outcomes for DHACM and NAT, such as amputations, and healthcare utilisation were tracked from claims codes, analysed and used to build a hybrid economic model, combining a one-year decision tree and a four-year Markov model. The budget impact was evaluated in the difference in per member per month spending following completion of the decision tree. Likewise, the cost-effectiveness was analysed before and after the Markov model at a willingness to pay (WTP) threshold of $100,000 per quality adjusted life year (QALY). The analysis was conducted from the healthcare sector perspective. RESULTS: There were 10,900,127 patients with a diagnosis of diabetes, of whom 1,213,614 had an LEDU. Propensity-matched Group 1 was generated from the 19,910 episodes that received AT. Only 9.2% of episodes were FPFU and DHACM was identified as the most widely used AT product among Medicare episodes. Propensity-matched Group 4 was limited by the 590 episodes that used DHACM FPFU. Episodes treated with DHACM FPFU had statistically fewer amputations and healthcare utilisation. In year one, DHACM FPFU provided an additional 0.013 QALYs, while saving $3,670 per patient. At a WTP of $100,000 per QALY, the five-year net monetary benefit was $5003. CONCLUSION: The findings of this study showed that DHACM FPFU reduced costs and improved clinical benefits compared with NAT for LEDU Medicare patients. DHACM FPFU provided better clinical outcomes than NAT by reducing major amputations, ED visits, inpatient admissions and readmissions. These clinical gains were achieved at a lower cost, in years 1-5, and were likely to be cost-effective at any WTP threshold. Adoption of best practices identified in this retrospective analysis is expected to generate clinically significant decreases in amputations and hospital utilisation while saving money.

US FDA-validated TLC method with four greenness assessment evaluations for simultaneous determination of prednisolone and esomeprazole in spiked human plasma.

Recently, prednisolone has been used in treating many medical conditions, such as autoimmune diseases and cancer. It is also prescribed to mitigate the respiratory complications caused by COVID-19 infection. It can cause some health complications, such as GIT ulcers, so it should be co-administered with proton-pump inhibitors, such as esomeprazole, to prevent the risk of ulcers. This work aims to develop an ecofriendly and sensitive TLC method for simultaneous determination of esomeprazole and prednisolone in their binary mixtures and spiked human plasma. Separation was performed using a mixture of ethyl acetate, methanol, and ammonia (9.5:0.5:0.1, v/v/v) as an eluting system with UV scanning at 245 nm. Dapoxetine was used as an internal standard to correct the variation during sampling. The resulting Rf values for plasma, esomeprazole, prednisolone, and dapoxetine were 0.03, 0.51, 0.72 and 0.85, respectively. Four greenness assessment tools-national environmental method index, eco-scale assessments, analytical greenness metric approach (AGREE), and green analytical procedure index (GAPI)-were used to evaluate the greenness characteristics of the proposed method to the environment, and the results were acceptable and satisfactory. Validation parameters were checked according to the US FDA guidelines to achieve the international requirements for bioanalytical method validation, and the results were within the accepted ranges.

Magnetically Controlled Capsule Endoscopy for Assessment of Antiplatelet Therapy-Induced Gastrointestinal Injury.

BACKGROUND: Gastrointestinal bleeding is the most frequent major complication of antiplatelet therapy. In patients at low bleeding risk, however, clinically overt gastrointestinal bleeding is relatively uncommon. OBJECTIVES: The authors sought to assess the effects of different antiplatelet regimens on gastrointestinal mucosal injury by means of a novel magnetically controlled capsule endoscopy system in patients at low bleeding risk. METHODS: Patients (n = 505) undergoing percutaneous coronary intervention in whom capsule endoscopy demonstrated no ulcerations or bleeding (although erosions were permitted) after 6 months of dual antiplatelet therapy (DAPT) were randomly assigned to aspirin plus placebo (n = 168), clopidogrel plus placebo (n = 169), or aspirin plus clopidogrel (n = 168) for an additional 6 months. The primary endpoint was the incidence of gastrointestinal mucosal injury (erosions, ulceration, or bleeding) at 6-month or 12-month capsule endoscopy. RESULTS: Gastrointestinal mucosal injury through 12 months was less with single antiplatelet therapy (SAPT) than with DAPT (94.3% vs 99.2%; P = 0.02). Aspirin and clopidogrel monotherapy had similar effects. Among 68 patients without any gastrointestinal injury at randomization (including no erosions), SAPT compared with DAPT caused less gastrointestinal injury (68.1% vs 95.2%; P = 0.006), including fewer new ulcers (8.5% vs 38.1%; P = 0.009). Clinical gastrointestinal bleeding from 6 to 12 months was less with SAPT than with DAPT (0.6% vs 5.4%; P = 0.001). CONCLUSIONS: Despite being at low risk of bleeding, nearly all patients receiving antiplatelet therapy developed gastrointestinal injury, although overt bleeding was infrequent. DAPT for 6 months followed by SAPT with aspirin or clopidogrel from 6 to 12 months resulted in less gastrointestinal mucosal injury and clinical bleeding compared with DAPT through 12 months. (OPT-PEACE [Optimal Antiplatelet Therapy for Prevention of Gastrointestinal Injury Evaluated by Ankon Magnetically Controlled Capsule Endoscopy]; NCT03198741).

The Reliability and Accuracy of Endoscopic Items and Scores Used in the Assessment of the Ileoanal Pouch and Cuff.

BACKGROUND AND AIMS: Currently used endoscopic items for the assessment of pouchitis and cuffitis have deficiencies in reliability and validation. We assessed the reliability and accuracy of new endoscopic items for pouchitis and of the Ulcerative Colitis Endoscopic Index of Severity [UCEIS] for cuffitis. METHODS: Three new endoscopic items were assessed and included in the Monash pouchitis endoscopic subscore: bleeding [absent/contact/spontaneous]; erosions [absent/<10/≥10]; and ulceration [absent/<10%/≥10%]. Three raters evaluated 44 pouchoscopy videos in duplicates, in random order. Intra- and inter-rater reliability of all endoscopic items and UCEIS were assessed. Clinical and histological pouchitis disease activity index [PDAI] subscores were also assessed and faecal calprotectin was measured. RESULTS: All three Monash endoscopic items had substantial intra-rater reliability with intraclass correlation coefficients [ICCs] >0.61 [95% CI >0.61], compared with only ulcers from the currently used PDAI endoscopic subscore, but inter-rater reliability was only substantial for ulceration and no better than those of the currently used endoscopic items. The Monash endoscopic subscore had a strong positive correlation with the reference standard global endoscopic lesion severity r = 0.80 [95% CI 0.80-0.80] and the reference standard PDAI endoscopic subscore r = 0.70 [95% CI 0.67-0.73], which was higher than the correlation observed for the currently used PDAI endoscopic subscore. The UCEIS had substantial intra-rater reliability, but only fair inter-rater reliability and poor diagnostic performance for cuffitis. CONCLUSIONS: The Monash endoscopic items, and endoscopic subscore they generate, have enhanced overall performance compared with the currently used PDAI items and subscore. Further validation and responsiveness to change in disease state are indicated.

A 4-week comparison of capillaroscopy changes, healing effect, and cost-effectiveness of botulinum toxin-A vs prostaglandin analog infusion in refractory digital ulcers in systemic sclerosis.

INTRODUCTION: Systemic sclerosis (SSc) is a systemic multi-organ disease. Raynaud's phenomenon (RP) and digital ulcers (DUs) in SSc patients can be resistant to usual treatments. We studied the clinical benefits, capillaroscopy changes, and cost-effectiveness of local injection of botulinum toxin-A (BTX-A) and intravenous prostaglandin analogs (iloprost/alprostadil) in patients with SSc with resistant DUs. METHOD: In a clinical trial study, we evaluated 26 patients fulfilling the ACR/EULAR SSc criteria with resistant DUs. Visual analog scale of pain and RP, skin color and type of ulcers, and capillaroscopy were assessed before and 1 month after treatment. In the first group, 20 units of BTX-A was injected at the base of each involved fingers by a dermatologist. In the second group, 20 µg iloprost or 60 µg alprostadil was infused daily. The cost of these treatments was compared. RESULT: In 26 patients (43 fingers), there were 16 patients (22 fingers) in the BTX-A and 10 patients (21 fingers) in the prostaglandin group. In 95.5% of the BTX-A and 90.5% of the prostaglandin group, the ulcers were healed. In both groups, a significant decrease in pain was seen (p < 0.0001). Capillaroscopy patterns in both groups were not changed although the microhemorrhages disappeared significantly (p value: BTX-A: 0.03 and prostaglandin: 0.002). The cost was significantly lower in the BTX-A injection group (p < 0.0001). CONCLUSION: Both BTX-A and prostaglandins helped in the healing and pain control of DUs. In capillaroscopy, microhemorrhages were significantly decreased in both groups. In the BTX-A group, the cost was significantly lower as an outpatient treatment and was more time-saving. KEY MESSAGES: • BTX-A and prostaglandin analogs both contributed to the healing of digital tip ulcers and improving the pain • In capillaroscopy, microhemorrhages were significantly decreased or disappeared after both treatments • There was no significant side effect in both groups • Comparing both groups, in the BTX-A group, the cost was significantly lower when performed on an outpatient treatment and more time-saving.

Colon Capsule Endoscopy in the Assessment of Mucosal Healing in Crohn's Disease.

BACKGROUND: Patients with Crohn's disease (CD) undergo frequent endoscopic procedures, with visualization of the gastrointestinal mucosa central to treatment decision-making. Subsequently, a noninvasive alternative to optical colonoscopy (OC) would be welcomed. One such technology is capsule endoscopy, including the PillCam COLON 2 (PCC2), though research validating its use in ileocolonic CD is limited. This study aims to compare PCC2 with ileocolonoscopy (OC) in assessing mucosal CD through use of a standardized scoring system. METHODS: At an Australian tertiary hospital, same-day PCC2 and ileocolonoscopy results of 47 CD patients, with known nonstricturing disease, were prospectively collected and analyzed for correlation and agreement. Deidentified recordings were reported by a single expert gastroenterologist. Mucosal disease was quantified using the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD results of paired endoscopic modalities were compared in total per bowel segment and per SES-CD variable. RESULTS: Of 47 PCC2 recordings, 68% were complete, fully assessing terminal ileum to rectum, and OC was complete in 89%. Correlation (r) between total SES-CD scores was strongest in the terminal ileum (r = 0.77, P < .001), with the SES-CD variable of "ulcer detection" showing the strongest agreement. The PCC2 (vs OC) identified additional ulcers in the terminal ileum; ascending, transverse, and descending colon; and rectum; scores were 5 (1), 5 (3), 1 (1), 2 (1), and 2 (2), respectively. CONCLUSIONS: The PCC2 shows promise in assessing ileocolonic mucosa, especially in proximal bowel segments, with greater reach of visualization in the small bowel. Given the resource and safety considerations raised by the Coronavirus disease 2019 pandemic, capsule endoscopy has particular significance.This article aims to contribute to the limited body of research surrounding the validity of capsule endoscopy technology in assessing ileocolonic mucosa in Crohn's Disease patients. In doing so, an alternative option for patients enduring frequent endoscopies is given potential.

Observed impact of skin substitutes in lower extremity diabetic ulcers: lessons from the Medicare Database (2015-2018).

OBJECTIVE: To evaluate large propensity-matched cohorts to assess outcomes in patients receiving advanced treatment (AT) with skin substitutes for lower extremity diabetic ulcers (LEDUs) versus no AT (NAT) for the management of LEDUs. METHOD: The Medicare Limited Dataset (1 October 2015 through 2 October 2018) were used to retrospectively analyse people receiving care for a LEDU treated with AT or NAT (propensity-matched Group 1). Analysis included major and minor amputations, emergency department (ED) visits and hospital readmissions. In addition, AT following parameters for use (FPFU) was compared with AT not FPFU (propensity-matched Group 2). A paired t-test was used for comparisons of the two groups. For comparisons of three groups, the Kruskal-Wallis test was used. A Bonferroni correction was performed when multiple comparisons were calculated. RESULTS: There were 9,738,760 patients with a diagnosis of diabetes, of whom 909,813 had a LEDU. In propensity-matched Group 1 (12,676 episodes per cohort), AT patients had statistically fewer minor amputations (p=0.0367), major amputations (p<0.0001), ED visits (p<0.0001), and readmissions (p<0.0001) compared with NAT patients. In propensity-matched Group 2 (1131 episodes per cohort), AT FPFU patients had fewer minor amputations (p=0.002) than those in the AT not FPFU group. CONCLUSION: AT for the management of LEDUs was associated with significant reductions in major and minor amputation, ED use, and hospital readmission compared with LEDUs managed with NAT. Clinics should implement AT in accordance with the highlighted parameters for use to improve outcomes and reduce costs.

Cost-minimization analysis of negative pressure wound therapy technologies for the treatment of moderate-to-severe foot infections.

Aim: The objective was to estimate the cost of care associated with two negative pressure wound therapy (NPWT) technologies used to treat patients admitted to the hospital with moderate-to-severe foot infections. Materials & methods: A decision tree simulation model was developed to estimate the hospital costs associated with two different NPWT technologies: Cardinal Health™ PRO (NPWT-C) and V.A.C. ULTA™ (NPWT-K). Clinical data were obtained from a previously completed single-site prospective trial. One-way and probabilistic sensitivity analyses were performed to gauge the robustness of the results. Results: The total expected per-patient costs were US$41,206 (SD: US$8,194) for NPWT-C and US$44,439 (SD: US$8,963) for NPWT-K. Conclusion: This study found that NPWT-C was expected to minimize the total costs over the episode of treatment. Larger and more clinically diverse studies are recommended to confirm these findings.

Visual assessment of digital ulcers in systemic sclerosis analysed by eye tracking: implications for wound assessment.

OBJECTIVES: The assessment of digital ulcers (DUs) in systemic sclerosis (SSc) depends crucially on visual aspects. However, little is known about the differences in visual assessment of these wounds between experts and non-experts or medical lay persons (novices). To develop potential training recommendations for the visual assessment of digital ulcers in SSc, we analysed gaze pattern data during assessment of digital ulcers between assessors with different levels of expertise. METHODS: Gaze pattern data from 36 participants were collected with a mobile eye tracking device. 20 pictures from digital ulcers of SSc patients were presented to each participant. The analysis comprised the scan path, the dwell times (for areas of interest), fixation counts and the entry time for each picture and subject. RESULTS: Most significant differences were found between novices and medically educated groups. Dwell times in the wound area for novices differed statistically significantly from all medically educated groups (1.76s-3.1s less). Above all, novices had lower dwell times in wound margin and wound surrounding and spent more time in other areas (up to 1.92s longer). Correspondingly, they had less fixation points and longer overall scan paths in wound areas. Similar gaze pattern data were generated for medically educated groups. CONCLUSIONS: For the first time, we could analyse the visual assessment of digital ulcers in SSc and detected differences according to levels of medical education and expertise. Adequate training on proper interpretation of changes in all wound areas are warranted to improve wound assessment in digital ulcers.

Population-Based Assessment of Aortic-Related Outcomes in Aortic Dissection, Intramural Hematoma, and Penetrating Aortic Ulcer.

BACKGROUND: The aim of the study was to analyze aortic-related outcomes after diagnosis of aortic dissection (AD), intramural hematoma (IMH), and penetrating aortic ulcer (PAU) from a population-based approach. METHODS: Retrospective review of an incident cohort of AD, IMH, and PAU patients in Olmsted County, Minnesota from 1995 to 2015. Primary end point was aortic death. Secondary end points were subsequent aortic events (aortic intervention, new dissection, or rupture not present at presentation) and first-time diagnosis of an aortic aneurysm. Outcomes were compared with randomly selected population referents matched for age and sex in a 3:1 ratio using Cox proportional hazards regression adjusting for comorbidities. RESULTS: Among 133 patients (77 AD, 21 IMH, and 35 PAU), 57% were males, and mean age was 71.8 years (standard deviation, 14). Median follow-up was 10 years. Of 73 deaths among AD/IMH/PAU patients, 23 (32%) were aortic-related. Estimated freedom from aortic death was 84%, 80%, and 77% at 5, 10, and 15 years. There were no aortic deaths among population referents (adjusted hazard ratio [HR] for aortic death in AD/IMH/PAU, 184.7; 95% confidence interval [95% CI], 10.3-3,299.2; P < 0.001). Fifty (38%) AD/IMH/PAU patients had a subsequent aortic event (aortic intervention, new dissection, or rupture), whereas there were 8 (2%) aortic events among population referents (all elective aneurysm repairs; adjusted HR for any aortic event and aortic intervention in AD/IMH/PAU patients, 33.3; 95% CI, 15.3-72.0; P < 0.001 and 31.5; 95% CI, 14.5-68.4; P < 0.001, respectively). After excluding aortic events/interventions ≤14 days of diagnosis, AD/IMH/PAU patients remained at increased risk of any aortic event (adjusted HR, 10.8; 95% CI, 3.9-29.8; P < 0.001) and aortic intervention (adjusted HR, 9.6; 95% CI, 3.4-26.8; P < 0.001). Among those subjects with available follow-up imaging, the risk of first-time diagnosis of aortic aneurysm was significantly increased for AD/IMH/PAU patients when compared with population referents (adjusted HR, 10.9; 95% CI, 5.4-21.7; P < 0.001 and 8.3; 95% CI, 4.1-16.7; P < 0.001 for thoracic and abdominal aneurysms, respectively) and remained increased when excluding aneurysms that formed within 14 days of AD/IMH/PAU (adjusted HR, 6.2; 95% CI, 1.8-21.1; P = 0.004 and 2.8; 95% CI, 1.0-7.6; P = 0.040 for thoracic and abdominal aneurysms, respectively). CONCLUSIONS: AD/IMH/PAU patients have a substantial risk of aortic death, any aortic event, aortic intervention, and first-time diagnosis of aortic aneurysm that persists even when the acute phase (≤14 days after diagnosis) is uncomplicated. Advances in postdiagnosis treatment are necessary to improve the prognosis in these patients.

Attenuation Coefficient Parameter Computations for Tissue Composition Assessment of Carotid Atherosclerotic Plaque in Vivo.

Quantitative ultrasound has been used to assess carotid plaque tissue composition. Here, we compute the attenuation coefficient (AC) in vivo with the optimum power spectral shift estimator (OPSSE) and reference phantom method (RPM), extract AC parameters and form parametric maps. Differences between OPSSE and RPM AC parameters are computed. Relationships between AC parameters, surgical scores and histopathology assessments are examined. Kendall's τ correlations between OPSSE AC and surgical scores are significant, including those between cholesterol and Standard Deviation (adjusted p = 0.038); thrombus and Minimum (adjusted p = 0.002), Maximum (adjusted p = 0.021) and Standard Deviation (adjusted p = 0.001); ulceration and Average (adjusted p = 0.033), Median (unadjusted p = 0.013), Maximum (unadjusted p = 0.039) and Mode (adjusted p = 0.009). The strongest correlations with histopathology are percentage cholesterol and Median OPSSE (unadjusted p = 0.007); percentage hemorrhage and Minimum OPSSE (adjusted p < 0.001); hemosiderin score and Median OPSSE (adjusted p = 0.010); and percentage calcium and Percentage Non-physical RPM Pixels (unadjusted p = 0.014). Kruskal-Wallis H and Dunn's post hoc tests have the ability to distinguish between groups (p < 0.05). Results suggest AC parameters may assist in vivo evaluation of carotid plaque vulnerability.

EMTALA (Emergency Medical Treatment and Active Labor Act) Obligations: A Case Report and Review of the Literature.

BACKGROUND: The Emergency Medical Treatment and Active Labor Act (EMTALA) was enacted in 1986 in the United States to address "patient dumping," or refusing to provide emergency care to patients and instead transferring them to other hospitals. Under EMTALA, the "reverse-dumping" provision prevents hospitals from refusing patients who require specialized capabilities or facilities if the hospital has the capacity to treat them. Despite this provision, patients continue to be transferred to distant tertiary care centers. METHODS: We reviewed the literature on EMTALA in the context of a critically ill woman with an infection associated with an orthopaedic implant who was rejected from 2 geographically closer tertiary care centers and was ultimately transferred by helicopter ambulance to an academic teaching hospital that was 169 miles away from her home. RESULTS: After transfer to our tertiary care, level-I trauma center, the patient spent 61 days in the intensive care unit; she required 9 operative procedures, which totaled 1,520 minutes of operative time. Eighteen medical specialties and 8 ancillary medical consulting teams were involved in her care. She underwent 1,436 laboratory and 83 radiographic studies. The total reimbursement from Medi-Cal (California's Medicaid program) for her care in our tertiary care center was $463,753; the hospital charges were more than tenfold higher. CONCLUSIONS: Dumping and reverse dumping continue despite compromise of patient care and the high financial burden of the accepting institutions. This may be due to ineffective monitoring and enforcement, lack of uniformity among the courts, and lack of incentive to receive uninsured or poorly funded patients. Under EMTALA, it is difficult for tertiary care centers to argue lack of specialized capabilities or capacity to accept patients, and neither hospitals nor physicians are compensated for the charges of providing care to uninsured or underinsured patients. Moving forward, efforts to better align financial incentives through cost-sharing between community hospitals and tertiary care centers, increased clinician literacy regarding the provisions of EMTALA, and increased transparency with hospital transfers may help improve EMTALA compliance and patient care.