The Cost-Effectiveness of Smoking Cessation Programs for Prevention of Wound Complications Following Total Ankle Arthroplasty: A Break-Even Analysis.

Background: Tobacco use significantly increases the rate of wound complications in patients undergoing total ankle arthroplasty (TAA). Preoperative optimization through smoking cessation programs significantly minimizes the rate of infection and improves wound healing in arthroplasty procedures. Despite its utility, minimal research has examined the cost-effectiveness of preoperative smoking cessation programs to reduce the need for extracapsular irrigation and debridement (I&D) due to wound complications following TAA. Methods: The cost of an I&D procedure was obtained from our institution's purchasing records. Baseline wound complication rates among tobacco users who have undergone TAA and smoking cessation program cost were obtained from literature. A break-even economic analysis was performed to determine the absolute risk reduction (ARR) to economically justify the implementation of preoperative smoking cessation programs. Different smoking cessation program and I&D costs were tested to account for variations in each factor. ARR was then used to calculate the number needed to treat (NNT) to prevent a single I&D while remaining cost-effective. Results: Smoking cessation programs were determined to be economically justified if it prevents 1 I&D surgery out of 8 TAAs among tobacco users (ARR = 12.66%) in the early postoperative period (<30 days). ARR was the same at the literature high (27.3%) and weighted literature average (13.3%) complication rates when using the cost of I&D surgery at our institution ($1757.13) and the literature value for a smoking cessation program ($222.45). Cost-effectiveness was maintained with higher I&D surgery costs and lower costs of smoking cessation treatment. Conclusion: Our model's input data suggest that the routine use of smoking cessation programs among tobacco users undergoing TAA is cost-effective for risk reduction of I&D surgery in the early postoperative period. This intervention was also found to be economically warranted with higher I&D costs and lower smoking cessation program costs than those found in the literature and at our institution.Level of Evidence: Level III, economic and decision analysis.

Anaerobic Wastewater Treatment and Potable Reuse: Energy and Life Cycle Considerations.

Anaerobic secondary treatment has the potential to facilitate energy-positive operations at wastewater treatment plants, but post-treatment of the anaerobic effluent is needed to recover dissolved methane and nutrients and remove sulfide. In this study, a life cycle assessment was conducted to compare hypothetical full-scale wastewater treatment trains and direct potable reuse trains that combine the staged anaerobic fluidized membrane bioreactor (SAF-MBR) with appropriate post-treatment. We found that anaerobic wastewater treatment trains typically consumed less energy than conventional aerobic treatment, but overall global warming potentials were not significantly different. Generally, recovery of dissolved methane for energy production resulted in lower life cycle impacts than microbial transformation of methane, and microbial oxidation of sulfide resulted in lower environmental impacts than chemical precipitation. Use of reverse osmosis to produce potable water was also found to be a sustainable method for nutrient removal because direct potable reuse trains with the SAF-MBR consumed less energy and had lower life cycle impacts than activated sludge. Moving forward, dissolved methane recovery, reduced chemical usage, and investments that enable direct potable reuse have been flagged as key research areas for further investigation of anaerobic secondary treatment options.

Sequential early-life viral infections modulate the microbiota and adaptive immune responses to systemic and mucosal vaccination.

Increasing evidence points to the microbial exposome as a critical factor in maturing and shaping the host immune system, thereby influencing responses to immune challenges such as infections or vaccines. To investigate the effect of early-life viral exposures on immune development and vaccine responses, we inoculated mice with six distinct viral pathogens in sequence beginning in the neonatal period, and then evaluated their immune signatures before and after intramuscular or intranasal vaccination against SARS-CoV-2. Sequential viral infection drove profound changes in all aspects of the immune system, including increasing circulating leukocytes, altering innate and adaptive immune cell lineages in tissues, and markedly influencing serum cytokine and total antibody levels. Beyond these immune responses changes, these exposures also modulated the composition of the endogenous intestinal microbiota. Although sequentially-infected mice exhibited increased systemic immune activation and T cell responses after intramuscular and intranasal SARS-CoV-2 immunization, we observed decreased vaccine-induced antibody responses in these animals. These results suggest that early-life viral exposures are sufficient to diminish antibody responses to vaccination in mice, and highlight their potential importance of considering prior microbial exposures when investigating vaccine responses.

Factors Associated With Amputation Following Ankle Fracture Surgery.

Patients with diabetes mellitus (DM) are at increased risk of complications following ankle fracture surgery. Previous research suggests that patients of low socioeconomic status are at increased risk of amputation following orthopedic complications. The purpose of this research was to determine if low socioeconomic status increases risk of below-knee amputation (BKA) following ankle fractures among patients with DM. The National Inpatient Sample (NIS) was queried from 2010 to 2014 to identify 125 diabetic patients who underwent ankle fracture surgical fixation followed by BKA. Two cohorts (BKA vs no BKA) and a multivariate logistic regression model were created to compare the effects of independent variables, including age, sex, race, primary payer, median household income by ZIP code, hospital location/teaching status, and comorbidities. The most predictive variables for BKA were concomitant peripheral vascular disease (odds ratio [OR] 5.35, 95% confidence interval [CI] 3.51-8.15), history of chronic diabetes-related medical complications (OR 3.29, CI 2.16-5.01), age in the youngest quartile (OR 2.54, CI 1.38-4.67), and male sex (OR 2.28, CI 1.54-3.36). Patient race and median household income were not significantly associated with BKA; however, risk of BKA was greater among patients with Medicaid (OR 2.23, CI 1.09-4.53) or Medicare (OR 1.85, CI 1.03-3.32) compared to privately insured patients. Diabetic inpatients with Medicaid insurance are at over twice the odds of BKA compared to privately insured patients following ankle fracture. Furthermore, peripheral vascular diseases, uncontrolled diabetes, younger age, and male sex each independently increase risk of BKA.

Efficacy of a novel online integrated treatment for problem gambling and tobacco smoking: Results of a randomized controlled trial.

Background and aims: Problem gambling and tobacco use are highly comorbid among adults. However, there are few treatment frameworks that target both gambling and tobacco use simultaneously (i.e., an integrated approach), while also being accessible and evidence-based. The aim of this two-arm open label RCT was to examine the efficacy of an integrated online treatment for problem gambling and tobacco use. Methods: A sample of 209 participants (Mage = 37.66, SD = 13.81; 62.2% female) from North America were randomized into one of two treatment conditions (integrated [n = 91] or gambling only [n = 118]) that lasted for eight weeks and consisted of seven online modules. Participants completed assessments at baseline, after treatment completion, and at 24-week follow-up. Results: While a priori planned generalized linear mixed models showed no condition differences on primary (gambling days, money spent, time spent) and secondary outcomes, both conditions did appear to significantly reduce problem gambling and smoking behaviours over time. Post hoc analyses showed that reductions in smoking and gambling craving were correlated with reductions in days spent gambling, as well as with gambling disorder symptoms. Relatively high (versus low) nicotine replacement therapy use was associated with greater reductions in gambling behaviours in the integrated treatment condition. Discussion and conclusions: While our open label RCT does not support a clear benefit of integrated treatment, findings suggest that changes in smoking and gambling were correlated over time, regardless of treatment condition, suggesting that more research on mechanisms of smoking outcomes in the context of gambling treatment may be relevant.

Few Randomized Controlled Trials in Spine Surgery in the United States Include Sociodemographic Patient Data: A Systematic Review.

INTRODUCTION: The importance of sociodemographic factors such as race, education, and income on spine surgery outcomes has been well established, yet the representation of sociodemographic data within randomized controlled trials (RCTs) in spine literature remains undefined in the United States (U.S). METHODS: Medical literature was reviewed within PubMed for RCTs with "spine" in the title or abstract published within the last 8 years (2014 to 2021) in seven major spine journals. This yielded 128 results, and after application of inclusion criteria (RCTs concerning adult spine pathologies conducted in the U.S), 54 RCTs remained for analysis. Each article's journal of publication, year of publication, and spinal pathology was recorded. Pathologies included cervical degeneration, thoracolumbar degeneration, adult deformity, cervical trauma, and thoracolumbar trauma. Sociodemographic variables collected were race, ethnicity, insurance status, income, work status, and education. The Fisher's exact test was used to compare inclusion of sociodemographic data by journal, year, and spinal pathology. RESULTS: Sociodemographic data were included in the results and in any section of 57.4% (31/54) of RCTs. RCTs reported work status in 25.9% (14/54) of results and 38.9% (21/54) of RCTs included work status in any section. Income was included in the results and mentioned in any section in 13.0% (7/54) of RCTs. Insurance status was in the results or any section of 9.3% (5/54) and 18.5% (10/54) of RCTs, respectively. There was no association with inclusion of sociodemographic data within the results of RCTs as a factor of journal ( P = 0.337), year of publication ( P = 0.286), or spinal pathology ( P = 0.199). DISCUSSION: Despite evidence of the importance of sociodemographic factors on the natural history and treatment outcomes of myriad spine pathologies, this study identifies a surprising absence of sociodemographic data within contemporary RCTs in spine surgery. Failure to include sociodemographic factors in RCTs potentially bias the generalizability of outcome data.

Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database.

STUDY DESIGN: Cross-Sectional Analysis. OBJECTIVES: To summarize medical device reports (MDRs) between August 1, 2017 and November 30, 2021 relating to robot-assisted spine systems within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA). METHODS: The MAUDE database was abstract for all MDRs relating to each FDA-approved robot-assisted spine system. Event descriptions were reviewed and characterized into specific event types. Outcome measures include specific robot-assisted spine systems and reported events as detailed by the MDRs. All data is de-identified and in compliance with the Health Insurance Portability and Accountability Act (HIPAA). RESULTS: There were 263 MDRs consisting of 265 reported events. Misplaced screws represented 61.5% (n = 163) of reported events. Of the 163 reported events, 57.1% (n = 93) described greater than 1 misplaced screw, 15.3% (n = 25) required return to the operating room, 8.6% (n = 14) resulted in neurologic injury, 4.3% (n = 7) resulted in dural tear, and 1.2% (n = 2) resulted in hemorrhage or bleeding. Reported events other than misplaced screws included system imprecision detected prior to screw placement (58/265, 21.9%), mechanical failure (23/265, 8.7%), and software failure (18/265, 6.8%). CONCLUSIONS: As more robot-assisted spine systems gain FDA approval and the adoption of these systems continues to grow, documenting and understanding the range of reported events associated with each "tool" is imperative to balancing patient safety with surgical innovation. This study of the MAUDE database provides a unique summary of reported events associated with robot-assisted spine systems that is not directly linked to a research setting.

Outcomes After Transfer of Pediatric Trauma Patients: Does Everyone Need to Visit the Trauma Bay?

INTRODUCTION: Critically injured children and teens often present to adult trauma centers or nontrauma facilities prior to transfer to a pediatric trauma center. For pediatric patients wanting transfer to the intensive care unit (ICU), there is little data to guide which can be safely transferred directly to the unit, and which should be evaluated first in the trauma bay. METHODS: We used our institutional trauma registry to evaluate transferred trauma patients over a three year period. We compared time to imaging, time to operating room, and overall mortality between the group evaluated first in the emergency room and those transferred directly to the ICU. RESULTS: When adjusted for other variables, there was no increased mortality in those transferred directly to the ICU. While there was a higher nonadjusted mortality in those transferred to the ICU (13% versus 3.7%), these nonsurvivors had a lower GCS (3 versus 13), higher Pediatric Risk of Mortality scores, and a high rate of severe head trauma. There was no significant delay in ordered imaging or procedures. CONCLUSIONS: In patients, who have been assessed at another institution prior to transfer to the pediatric ICU, transfer directly to the ICU, bypassing the emergency department, does not delay interventions and does not appear to worsen outcomes.

Elbow Osteochondral Allograft Transplantation and Lateral Ulnar Collateral Ligament Repair with Internal Brace: A Case Report.

CASE: A 23-year-old woman with an Osborne-Cotterill lesion and posterolateral rotatory instability (PLRI) of the elbow was treated with osteochondral allograft transplantation (OCA) and lateral ulnar collateral ligament (LUCL) repair with internal brace. Two years after surgery, she reported resolution of pain and returned to all recreational activities. She reported no mechanical symptoms and no episodes of postoperative instability. CONCLUSION: PLRI can present with an Osborne-Cotterill lesion in addition to LUCL injury. The purpose of this case report was to describe the use of OCA to manage bony defects in the capitellum in addition to LUCL repair for patients with PLRI.

Development and Feasibility of a Web-Based Decision Aid for Patients With Ulcerative Colitis: Qualitative Pilot Study.

BACKGROUND: Shared decision making (SDM) is becoming an important part of ulcerative colitis (UC) management because of the increasing complexity of available treatment choices and their trade-offs. The use of decision aids (DA) may be effective in increasing patients' participation in UC management but their uptake has been limited due to high attrition rates and lack of a participatory approach to their design and implementation. OBJECTIVE: The primary aim of this study is to explore the perspectives of Australian patients and their clinicians regarding the feasibility and acceptability of myAID, a web-based DA, in informing treatment decisions in UC. The secondary aim is to use the findings of this pilot study to inform the design of a cluster randomized clinical trial (CRCT) to assess the efficacy of the DA compared with usual care. METHODS: myAID, a DA was designed and developed using a participatory approach by a multidisciplinary team of clinicians, patients, and nonmedical volunteers. A qualitative pilot study to evaluate the DA, involving patients with UC facing new treatment decisions and inflammatory bowel disease clinicians, was undertaken. RESULTS: A total of 11 patients with UC and 15 clinicians provided feedback on myAID. Themes explored included the following: Acceptability and usability of myAID-myAID was found to be acceptable by the majority of clinicians as a tool to facilitate SDM, uptake was thought to vary depending on clinicians' approaches to patient education and practice, potential to overcome time restrictions associated with outpatient clinics was identified, presentation of unbiased information enabling patients to digest information at their own pace was noted, and potential to provoke anxiety among patients with a new diagnosis or mild disease was raised; Perceived role and usefulness of myAID-discordance was observed between patients who prioritized voicing preferences and clinicians who prioritized treatment adherence, and myAID facilitated early discussion of medical versus surgical treatment options; Target population and timing of use-greatest benefit was perceived at the time of initiating or changing treatment and following commencement of immunosuppressive therapy; and Potential concerns and areas for improvement-some perceived that use of myAID may precipitate anxiety by increasing decisional conflict and impact the therapeutic relationship between patient and the clinician and may increase resource requirements. CONCLUSIONS: These preliminary findings suggest that patients and clinicians consider myAID as a feasible and acceptable tool to facilitate SDM for UC management. These pilot data have informed a participatory approach to the design of a CRCT, which will evaluate the clinical efficacy of myAID compared with usual care. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry ACTRN12617001246370; http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617001246370.

A Web-Based Decision Aid (myAID) to Enhance Quality of Life, Empowerment, Decision Making, and Disease Control for Patients With Ulcerative Colitis: Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: Patients with ulcerative colitis (UC) often face complex treatment decisions. Although shared decision making (SDM) is considered important, tools to facilitate this are currently lacking for UC. A recent pilot study of a novel Web-based decision aid (DA), my Actively Informed Decision (myAID), has suggested its acceptability and feasibility for informing treatment decisions and facilitating SDM in clinical practice. OBJECTIVE: This paper describes the study protocol of the myAID study to assess the clinical impact of systematic implementation of myAID in routine UC management. METHODS: The myAID study is a multicenter, cluster randomized controlled trial (CRCT) involving 22 Australian sites that will assess the clinical efficacy of routine use of myAID (intervention) against usual care without access to myAID (control) for UC patients. Participating sites (clusters) will be randomly allocated in a 1:1 ratio between the 2 arms. Patients making a new treatment decision beyond 5-aminosalicylate agents will be eligible to participate. Patients allocated to the intervention arm will view myAID at the time of recruitment and have free access to it throughout the study period. The effect of the myAID intervention will be assessed using the results of serial Web-based questionnaires and fecal calprotectin at baseline, 2 months, 6 months, and 12 months. A Web-based questionnaire within 2-4 weeks of referral will determine early change in quality of decision making and anxiety (both arms) and intervention acceptability (intervention arm only). RESULTS: Study recruitment and funding began in October 2016, and recruitment will continue through 2020, for a minimum of 300 study participants at baseline at the current projection. The primary outcome will be health-related quality of life (Assessment of Quality of Life-8D), and secondary outcomes will include patient empowerment, quality of decision making, anxiety, work productivity and activity impairment, and disease activity. In addition, we aim to determine the predictors of UC treatment decisions and outcomes and the cost-effectiveness of implementing myAID in routine practice. Feedback obtained about myAID will be used to determine areas for improvement and barriers to its implementation. Completion of data collection and publication of study results are anticipated in 2021. CONCLUSIONS: myAID is a novel Web-based DA designed to facilitate SDM in UC management. The results of this CRCT will contribute new evidence to the literature in comparing outcomes between patients who routinely access such decision support intervention versus those who do not, across multiple large inflammatory bowel disease centers as well as community-based private practices in Australia. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry ACTRN12617001246370 http://anzctr.org.au/Trial/ Registration/TrialReview.aspx?ACTRN=12617001246370. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15994.

Granular sludge is a preferable inoculum for the biochemical methane potential assay for two complex substrates.

The biochemical methane potential (BMP) assay is a standard method for characterizing biomethane potential and anaerobic biodegradability organic waste streams. Therefore, the BMP protocol must be standardized to reliably compare these parameters for various substrates. Here, the effect of inoculum selection on biomethane potential was investigated through BMP tests using two different substrates and inocula obtained from four different anaerobic digesters. It was found that inocula in the form of granular sludge yielded overall higher biomethane potential and generally had faster kinetics than suspended biomass. Furthermore, acclimation of inocula to substrate appeared to have little effect on degradation rates, and co-inoculation (with both suspended and granular biomass) did not perform better than single inoculation (e.g., with suspended sludge alone). These results emphasize the role of granular sludge as an preferable inoculum for BMP assay.

Wildfire prevention through prophylactic treatment of high-risk landscapes using viscoelastic retardant fluids.

Polyphosphate fire retardants are a critical tactical resource for fighting fires in the wildland and in the wildland-urban interface. Yet, application of these retardants is limited to emergency suppression strategies because current formulations cannot retain fire retardants on target vegetation for extended periods of time through environmental exposure and weathering. New retardant formulations with persistent retention to target vegetation throughout the peak fire season would enable methodical, prophylactic treatment strategies of landscapes at high risk of wildfires through prolonged prevention of ignition and continual impediment to active flaming fronts. Here we develop a sprayable, environmentally benign viscoelastic fluid comprising biopolymers and colloidal silica to enhance adherence and retention of polyphosphate retardants on common wildfire-prone vegetation. These viscoelastic fluids exhibit appropriate wetting and rheological responses to enable robust retardant adherence to vegetation following spray application. Further, laboratory and pilot-scale burn studies establish that these materials drastically reduce ignition probability before and after simulated weathering events. Overall, these studies demonstrate how these materials actualize opportunities to shift the approach of retardant-based wildfire management from reactive suppression to proactive prevention at the source of ignitions.

Developing a Standard Set of Patient-Centred Outcomes for Inflammatory Bowel Disease-an International, Cross-disciplinary Consensus.

BACKGROUND AND AIMS: Success in delivering value-based healthcare involves measuring outcomes that matter most to patients. Our aim was to develop a minimum Standard Set of patient-centred outcome measures for inflammatory bowel disease [IBD], for use in different healthcare settings. METHODS: An international working group [n = 25] representing patients, patient associations, gastroenterologists, surgeons, specialist nurses, IBD registries and patient-reported outcome measure [PROM] methodologists participated in a series of teleconferences incorporating a modified Delphi process. Systematic review of existing literature, registry data, patient focus groups and open review periods were used to reach consensus on a minimum set of standard outcome measures and risk adjustment variables. Similar methodology has been used in 21 other disease areas [www.ichom.org]. RESULTS: A minimum Standard Set of outcomes was developed for patients [aged ≥16] with IBD. Outcome domains included survival and disease control [survival, disease activity/remission, colorectal cancer, anaemia], disutility of care [treatment-related complications], healthcare utilization [IBD-related admissions, emergency room visits] and patient-reported outcomes [including quality of life, nutritional status and impact of fistulae] measured at baseline and at 6 or 12 month intervals. A single PROM [IBD-Control questionnaire] was recommended in the Standard Set and minimum risk adjustment data collected at baseline and annually were included: demographics, basic clinical information and treatment factors. CONCLUSIONS: A Standard Set of outcome measures for IBD has been developed based on evidence, patient input and specialist consensus. It provides an international template for meaningful, comparable and easy-to-interpret measures as a step towards achieving value-based healthcare in IBD.

Proline-Based Cyclic Dipeptides from Korean Fermented Vegetable Kimchi and from Leuconostoc mesenteroides LBP-K06 Have Activities against Multidrug-Resistant Bacteria.

Lactobacillus plantarum and Leuconostoc mesenteroides play a prominent role as functional starters and predominant isolates in the production of various types of antimicrobial compound-containing fermented foods, especially including kimchi. In the case of the bioactive cyclic dipeptides, their racemic diastereomers inhibitory to bacteria and fungi have been suggested to come solely from Lactobacillus spp. of these strains. We previously demonstrated the antifungal and antiviral activities of proline-based cyclic dipeptides, which were fractionated from culture filtrates of Lb. plantarum LBP-K10 originated from kimchi. However, cyclic dipeptides have not been identified in the filtrates, either from cultures or fermented subject matter, driven by Ln. mesenteroides, which have been widely used as starter cultures for kimchi fermentation. Most importantly, the experimental verification of cyclic dipeptide-content changes during kimchi fermentation have also not been elucidated. Herein, the antibacterial fractions, including cyclo(Leu-Pro) and cyclo(Phe-Pro), from Ln. mesenteroides LBP-K06 culture filtrates, which exhibited a typical chromatographic retention behavior (tR), were identified by using semi-preparative high-performance liquid chromatography and gas chromatography-mass spectrometry. Based on this finding, the proline-based cyclic dipeptides, including cyclo(Ser-Pro), cyclo(Tyr-Pro), and cyclo(Leu-Pro), were additionally identified in the filtrates only when fermenting Chinese cabbage produced with Ln. mesenteroides LBP-K06 starter cultures. The detection and isolation of cyclic dipeptides solely in controlled fermented cabbage were conducted under the control of fermentation-process parameters concomitantly with strong CDP selectivity by using a two-consecutive-purification strategy. Interestingly, cyclic dipeptides in the filtrates, when using this strain as a starter, increased with fermentation time. However, no cyclic dipeptides were observed in the filtrates of other fermented products, including other types of kimchi and fermented materials of plant and animal origin. This is the first report to conclusively demonstrate evidence for the existence of antimicrobial cyclic dipeptides produced by Ln. mesenteroides in kimchi. Through filtrates from lactic acid bacterial cultures and from fermented foods, we have also proved a method of combining chromatographic fractionation and mass spectrometry-based analysis for screening cyclic dipeptide profiling, which may allow evaluation of the fermented dairy foods from a new perspective.

Coupling hydrothermal liquefaction and anaerobic digestion for energy valorization from model biomass feedstocks.

Hydrothermal liquefaction converts food waste into oil and a carbon-rich hydrothermal aqueous phase. The hydrothermal aqueous phase may be converted to biomethane via anaerobic digestion. Here, the feasibility of coupling hydrothermal liquefaction and anaerobic digestion for the conversion of food waste into energy products was examined. A mixture of polysaccharides, proteins, and lipids, representing food waste, underwent hydrothermal processing at temperatures ranging from 200 to 350°C. The anaerobic biodegradability of the hydrothermal aqueous phase was examined through conducting biochemical methane potential assays. The results demonstrate that the anaerobic biodegradability of the hydrothermal aqueous phase was lower when the temperature of hydrothermal processing increased. The chemical composition of the hydrothermal aqueous phase affected the anaerobic biodegradability. However, no inhibition of biodegradation was observed for most samples. Combining hydrothermal and anaerobic digestion may, therefore, yield a higher energetic return by converting the feedstock into oil and biomethane.