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Mu2e at Fermilab will search for charged lepton flavor violation via thecoherent conversion process mu- N --> e- N with a sensitivity approximatelyfour orders of magnitude better than the current world's best limits for thisprocess. The experiment's sensitivity offers discovery potential over a widearray of new physics models and probes mass scales well beyond the reach of theLHC. We describe herein the conceptual design of the proposed Mu2e experiment.This document was created in partial fulfillment of the requirements necessaryto obtain DOE CD-1 approval, which was granted July 11, 2012.

Background: Vitiligo lesions are often challenging to repigment with conventional medical therapies. Surgical autologous melanocyte transfer methods can be utilized for stable vitiligo but demand specialized skills and equipment. A point-of-care autologous cell harvesting device was designed enabling simple preparation of autologous skin cell suspension (ASCS) containing melanocytes, keratinocytes, and fibroblasts providing a straightforward approach for cellular transplantation., Objective: To evaluate the safety and effectiveness of ASCS for repigmentation of stable vitiligo lesions among adults., Methods: A US multicenter, randomized, within-subject controlled trial compared ASCS to narrow band ultraviolet B only (Control) in similar vitiligo lesions. ASCS was applied after laser skin resurfacing and followed by narrow band ultraviolet B treatment. The primary effectiveness endpoint was the proportion of lesions achieving ≥80% repigmentation at week-24. Repigmentation durability was assessed at week-52., Results: Among 25 subjects, 36% of ASCS-treated lesions achieved ≥80% repigmentation at week-24 compared to 0% for Control (P < .025), with durability through week-52. The safety profile of ASCS was acceptable, with favorable patient- and investigator-reported outcomes., Limitations: Study sample size limited robust subgroup analyses., Conclusion: Application of ASCS has potential as a treatment for repigmentation of stable vitiligo lesions with the potential to improve health-related quality of life and reduce burden of disease., Competing Interests: Conflicts of interest Dr Hamzavi has served as an advisory board member for AbbVie; a consultant for Boehringer Ingelheim, AVITA Medical, Galderma Laboratories LP, Incyte, Pfizer, and UCB; a principal investigator for AVITA, Bayer, Estée Lauder, Ferndale Laboratories, Incyte Corporation, Lenicura, L’Oréal, Pfizer, and Unigen; immediate past president of the HS Foundation; and a board member of the Global Vitiligo Foundation. Dr Ganesan is an investigator for AVITA and AbbVie. Dr Mahmoud is an investigator for AVITA. Dr Munavalli is an investigator and speaker for AVITA. Dr Kahn is an investigator and speaker for AVITA and Vericel Inc, a DSMB consultant for Polynovo, and an investigator and medical monitor for Spectral MD. Dr Huang has served on an advisory panel for Incyte and as an investigator for Abbvie. Dr Waibel has served as an advisory board member for Bellamia, Cytrellis Biosystems, and RegenX; a consultant for Allergan, Candela, Cytrellis Biosystems, P&G, Skinceuticals, and Turn.Bio; an investigator for Amgen, ArgenX, Bristol Myers Squibb, Cytrellis Biosystems, Eli Lily, Emblation, Galderma, Horizon, Janssen, Neuronetics, Pfizer, RegenX, Sanofi, Skincueticals, and Shanghi Biopharma, PWB; a speaker for Candela and Eli Lily; she has received a Veterans Affairs Merit Grant - Amputated Veterans. Dr Elbuluk has served as a consultant, advisory board member, and/or speaker for AVITA, Incyte, VisualDx, La Roche Posay, Beiersdorf, Unilever, Allergan, Eli Lilly, Galderma, Pfizer, Takeda, AbbVie, Janssen, Sanofi, L’Oreal, McGraw Hill, Dior, Medscape; she has grant funding from Pfizer, has received royalties from McGraw-Hill and has stock options in VisualDx. Dr Pandya has served as an investigator for Incyte, AVITA, Clinuvel; a consultant for AbbVie, AVITA, Boehringer Ingelheim, Immune Tolerance Network, Incyte, Lilly, Pfizer, Sun, Thalocan, WCG, Villaris, Vimela, Vyne; and has partial owndership of Tara Medical. Drs Weiss, Ahmed, Robinson, Goldman, A. Desai and S. Desai have no conflicts of interest to declare., (Copyright © 2024 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Fecal Microbiota Transplant (FMT) has shown some success in treating inflammatory bowel diseases (IBD). There is emerging evidence that host engraftment of donor taxa is a tenet of successful FMT. We undertook a double-blind, randomized, placebo-controlled pilot study to characterize the response to FMT in children and young adults with mild to moderate active Crohn's disease (CD) and ulcerative colitis (UC). Subjects with CD or UC were randomized to receive antibiotics and weekly FMT or placebo in addition to baseline medications. We enrolled 15 subjects aged 14-29 years. Four subjects had CD, and 11 had UC. Subjects exhibited a wide range of microbial diversity and donor engraftment. Specifically, engraftment ranged from 26 to 90% at week 2 and 3-92% at 2 months. Consistent with the current literature, increases over time of both alpha diversity (p < 0.05) and donor engraftment (p < 0.05) correlated with improved clinical response. We discovered that the post-antibiotic but pre-FMT time point was rich in microbial correlates of eventual engraftment. Greater residual alpha diversity after antibiotic treatment was positively correlated with engraftment and subsequent clinical response. Interestingly, a transient rise in the relative abundance of Lactobacillus was also positively correlated with engraftment, a finding that we recapitulated with our analysis of another FMT trial., (© 2024. The Author(s).)

CO2 ablative fractional laser (CO2 AFL) therapy is a safe and effective procedure when used in the treatment of hypertrophic scars for burn patients. It has a high patient satisfaction rate and a minimal side effect profile, typically consisting of postoperative pain, irritation, surgical site inflammation, and, in rare cases, infection. Although prophylactic antibiotics have historically been recommended, there is a paucity of literature on the topic and recent studies indicate that they may be unnecessary in routine cases. In this retrospective, single center descriptive study, 230 cases in patients with hypertrophic burn scars treated with CO2 AFL therapy were compared. 28 cases were with the use of prophylactic antibiotics and 201 cases were without the use of prophylactic antibiotics. We found that there was no significant association between the use of antibiotics and the prevention of topical skin infection in cases treated with CO2 AFL therapy (p=1). Therefore, we conclude that the omission of prophylactic antibiotics is not associated with an increased risk of infection and recommend that prophylactic antibiotics should not be indicated in the setting of routine CO2 AFL therapy for patients with hypertrophic burn scars., (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Burn Association. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Despite differing etiologies, acute thermal burn injuries and full-thickness (FT) skin defects are associated with similar therapeutic challenges. When not amenable to primary or secondary closure, the conventional standard of care (SoC) treatment for these wound types is split-thickness skin grafting (STSG). This invasive procedure requires adequate availability of donor skin and is associated with donor site morbidity, high healthcare resource use (HCRU), and costs related to prolonged hospitalization. As such, treatment options that can facilitate effective healing and donor skin sparing have been highly anticipated. The RECELL ® Autologous Cell Harvesting Device facilitates preparation of an autologous skin cell suspension (ASCS) for the treatment of acute thermal burns and FT skin defects. In initial clinical trials, the approach showed superior donor skin-sparing benefits and comparable wound healing to SoC STSG among patients with acute thermal burn injuries. These findings led to approval of RECELL for this indication by the US Food and Drug Administration (FDA) in 2018. Subsequent clinical evaluation in non-thermal FT skin wounds showed that RECELL, when used in combination with widely meshed STSG, provides donor skin-sparing advantages and comparable healing outcomes compared with SoC STSG. As a result, the device received FDA approval in June of 2023 for treatment of FT skin defects caused by traumatic avulsion or surgical excision or resection. Given that health economic advantages have been demonstrated for RECELL ± STSG versus STSG alone when used for burn therapy, it is prudent to examine similarities in the burn and FT skin defect treatment pathways to forecast the potential health economic advantages for RECELL when used in FT skin defects. This article discusses the parallels between the two indications, the clinical outcomes reported for RECELL, and the HCRU and cost benefits that may be anticipated with use of the device for non-thermal FT skin defects., (© 2024. The Author(s).)

Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) exist on a spectrum of autoimmune conditions which cause epidermal detachment and keratinocyte necrosis. Due to the rare incidence of these conditions, a dramatic heterogeneity in treatment algorithms exists. To better appreciate pharmacologic immunosuppressive therapies' impact on survival, the authors queried a multi-institutional data network. Data for this study was extracted from TriNetX Research Network, a platform that contains ICD-9/ICD-10 coding data from a consortium of international healthcare organizations. Seventy-one institutions were queried to identify adult patients diagnosed with SJS, TEN or SJS-TEN Overlap. Cohorts were created based on the therapy received: systemic steroids (SS), diphenhydramine (DH), cyclosporine (CS), intravenous immunoglobulin (IVIG), tumor necrosis factor alpha inhibitors (TNFαi), or a combination of treatments. Cohorts were then propensity matched with patients who received supportive care. Patients who only received one of the above treatments showed no significant reduction in 90-day mortality. Patients who received CS or IVIG as part of their multitherapy showed a significantly increased risk of death when compared to supportive care (CS: RR = 1.583, 95% CI [1.119, 2.240]; IVIG: RR = 2.132, 95% CI [1.485, 3.059]). Despite their frequent utilization, this study's analysis suggests that none of these therapies confer significant 90-day mortality survival over supportive care alone. These results highlight the heterogeneity of therapies and emphasize the need for critical prospective appraisal of their outcomes in SJS and TEN., Competing Interests: Declaration of competing interest The authors declare that they have no conflicts of interest., (Copyright © 2023 Elsevier Ltd and International Society of Burns Injuries. All rights reserved.)

Minimally invasive surgery is becoming the standard of care across surgical subspecialties. Several new "minimally invasive" options for burn debridement and autografting exist. Enzymatic bromelain-based debridement (BBD) and autologous skin cell spray (ASCS) have independently proven to reduce the rate of split-thickness skin grafting (STSG) and decrease donor site size when grafting is performed. There is a paucity in the literature regarding the combination of these two therapies. The purpose of this study is to characterize a cohort of patients treated with both BBD and ASCS and qualitatively compare data to expected outcomes without these therapies. This retrospective study of a single academic burn center's experience using BBD and ASCS together included 13 patients with a total burn surface area (TBSA) from 1-30% and all had >50% deep partial thickness. All patients received BBD and ASCS. Deeper burns additionally received STSG with ASCS overspray. Median burn size was 14% TBSA (IQR:5.45,20), donor site size was 225 sq cm (IQR:28.5,556.5), and ratio of donor site area to total treatment area of 0.082 (IQR: 0.039, 0.241) was observed. Median observed length of stay (LOS) was 19 days (IQR:10,27), expected LOS was 15.4 days, and O/E ratio 1.06. Donor sites in both groups of patients were much smaller than expected versus treatment with conventional meshed STSG alone and length of stay is lower than expected based on burn size. An emphasis on expenses and scar development will guide future studies into the patient subset and wound features that are best for this combination treatment., (© 2023 Euro-Mediterranean Council for Burns and Fire Disasters.)

Fecal microbiota transplantation (FMT) involves the delivery of an entire microbial community from a healthy donor to a recipient with the intention of ameliorating or curing a specific disease. Current evidence strongly supports a role for FMT in the treatment of Clostridiodes difficile infection, with cure rates of approximately 80% to 90%. This success has led to increasing attention for FMT as a potential therapeutic intervention for other conditions associated with disturbances of the intestinal microbiome, including inflammatory bowel diseases, autism spectrum disorder, and obesity. This clinical report endorses the joint society statement by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, and the European Society for Pediatric Gastroenterology, Hepatology and Nutrition and is meant to provide the general pediatrician with a broad overview to enable appropriate guidance to families seeking FMT as treatment of a child's condition., (Copyright © 2023 by the American Academy of Pediatrics.)

Background: Fecal microbiota transplant (FMT) is an effective treatment for recurrent Clostridioides difficile infection (CDI). Safety concerns around FMT are increased in immunocompromised populations, such as solid organ transplant (SOT) recipients. Outcomes among adult SOT recipients suggest FMT is efficacious and safe; however, pediatric SOT data are lacking., Methods: We describe the efficacy and safety of FMT among pediatric SOT recipients in a single-center retrospective study from March 2016 to December 2019. Successful FMT was defined as no recurrence of CDI within 2 mo of FMT. We identified 6 SOT recipients ages 4-18 y who received FMT a median of 5.3 y post-SOT., Results: Success after a single FMT was 83.3%. One liver recipient did not achieve cure after 3 FMTs and remains on low-dose vancomycin. One serious adverse event (SAE) occurred; cecal perforation and bacterial peritonitis occurred following colonoscopic FMT coordinated with intestinal biopsy in a kidney transplant recipient. He achieved full recovery and CDI cure. There were no other SAEs. There were no adverse events related to immunosuppression or transplantation status including: bacteremia, cytomegalovirus activation or reactivation, allograft rejection, or allograft loss., Conclusions: In this limited series, efficacy of FMT in pediatric SOT is comparable to efficacy in the general pediatric recurrent CDI population. There may be an increased risk of procedure-related SAE in SOT patients and larger cohort studies are needed., Competing Interests: K.P.D. has served as a consultant for CareDx. N.M.R. serves on a Safety Review Committee for Dicerna Pharmaceuticals. The other authors declare no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

With the approval and development of narrow-spectrum antibiotics for the treatment of Clostridioides difficile infection (CDI), the primary endpoint for treatment success of CDI antibiotic treatment trials has shifted from treatment response at end of therapy to sustained response 30 days after completed therapy. The current definition of a successful response to treatment (three or fewer unformed bowel movements [UBMs] per day for 1-2 days) has not been validated, does not reflect CDI management, and could impair assessments for successful treatment at 30 days. We propose new definitions to optimise trial design to assess sustained response. Primarily, we suggest that the initial response at the end of treatment be defined as (1) three or fewer UBMs per day, (2) a reduction in UBMs of more than 50% per day, (3) a decrease in stool volume of more than 75% for those with ostomy, or (4) attainment of bowel movements of Bristol Stool Form Scale types 1-4, on average, by day 2 after completion of primary CDI therapy (ie, assessed on day 11 and day 12 of a 10-day treatment course) and following an investigator determination that CDI treatment can be ceased., Competing Interests: Declaration of interests AMS is supported by career development awards from the US Veteran Affairs and Institute for Translational Medicine, serves on an advisory board for Recursion Pharmaceuticals, and has accepted honoraria from the American Society of Healthcare Pharmacists and the Academy for Continued Healthcare Learning. CDA has been supported by an investigator-initiated grant from Merck; serves on advisory boards for Cidara Therapeutics, Merck, and AiCuris; and has accepted honoraria from the American Society of Healthcare Pharmacists and the Academy for Continued Healthcare Learning. OAC has grants from Amplyx, Basilea, German Federal Ministry of Education and Research, Cidara, German Center for Infection Research, Commission's Directorate-General for Research and Innovation (101037867), F2G, Gilead, Matinas, MedPace, Merck Sharp & Dohme, Mundipharma, Octapharma, Pfizer, and Scynexis, has accepted consulting fees from AbbVie, Amplyx, Biocon, Biosys, Cidara, Da Volterra, Gilead, IQVIA, Janssen, Matinas, MedPace, Menarini, Molecular Partners, Mycoses Study Group Education & Research Consortium, Noxxon, Octapharma, Pardes, Pfizer, Pharmaceutical Security Institute, Scynexis, and Seres Therapeutics; has accepted speakernhonoraria from Abbot, AbbVie, Al-Jazeera Pharmaceuticals, Astellas, Gilead, Grupo Biotoscana/United Medical/Knight, Hikma, MedScape, MedUpdate, Merck/MSD, Mylan, Noscendo, Pfizer, and Shionogi; has served as an expert witness for Cidara; has participated on advisory boards for Actelion, Allecra, Cidara, Entasis, IQVIA, Janssen, MedPace, Paratek, PSI, Pulmocide, Shionogi, and the Prime Meridian Group; has filed for a patent with the German Patent and Trade Mark Office (Geschlossene Inkubationssysteme mit verbessertem Atemwegszugang für Untersuchungsvorrichtungen, DE 10 2021 113 007.7); has stock in CoRe Consulting; and has non-financial interests in the European Confederation of Medical Mycology, International Society for Human and Animal Mycology, Mycoses Study Group Education & Research Consortium, and Wiley Publishing. KWG is funded by investigator-initiated awards from Summit Therapeutics, Acurx, Paratek, and Seres Therapeutics. DNG has grants from the US Centers for Disease Control and Prevention and US Veteran Affairs, a licensing agreement with Destiny Pharma, and has accepted consulting fees from Destiny Pharma. SJ is funded by grants from Paratek and Destiny Pharma, has accepted consulting fees from Bio-K+, Acurx, Ferring Pharmaceuticals, and Summit Therapeutics, and serves on the data safety monitoring board for Pfizer. SAK is funded by the Crohn's and Colitis Foundation, the Mooney Family Initiative for Translational and Clinical Studies in Rare Diseases Translational Research Program, Cures Within Reach, and the National Institute of Allergy and Infectious Diseases; has accepted consulting fees from Guidepoint; has accepted honoraria from the Louisiana Academy of Nutrition & Diabetics and Boston IBD; has accepted travel support from the Crohn's and Colitis and Helmsley Foundations; serves on the Peggy Lillis Foundation advisory board; and holds Eli Lilly stock. CPK has grant funding from Milky Way Life Sciences, Pfizer, National Institutes of Health (NIH), Merck, and Takeda Pharmaceuticals; has accepted consulting fees from Artugen, Facile Therapeutics, Ferring Pharmaceuticals, Finch Therapeutics, Pfizer, Milky Way Life Sciences, RVAC Medicines, Seres Therapeutics, and Summit Therapeutics; has a patent with Quanterix; serves on the advisory board for Finch Therapeutics; is secretary for the Foundation for Celiac Disease Outcome Measures; and has stock in First Light and Cour Pharmaceuticals. CRK has grant funding from the NIH; has accepted consulting fees from Sebela Pharmaceuticals; and has accepted speakers honoraria from the American College of Gastroenterology. LKK has research funding from Merck. TL has accepted funding from Summit, Crestone, MGB Biopharma, Actelion, Cubist/Merck, Seres Therapeutics, and Vedanta Biosciences; and has accepted consulting fees from MGB Biopharma and Seres Therapeutics. MJGTV has received grants from MSD, Heel, Biontech, and Roche; has accepted consulting fees from MaaT, Tillots, MSD/Merck, FAV00B, Dr Regenold, Roche, and EUMEDICA; and has accepted honoraria from Merck/MSD, 3M, Ferring Pharmaceuticals, Astellas, Uniklinik Karlsruhe, Uniklinik Köln, Akademia für Infektionsmedizin, Klinikum Essen, Pfizer, Universitätsklinikum Heidelberg, Uniklinik Frankfurt, Landesärztekammer Hessen, Janssen, Institut Merieux, Forum für medizinische Fortildung, Universitätsklinikum Freburg, Berliner Dialy Seminar, Zertifikatskurs PTA im Krankenhaus, Falk Foundation, St Johannes Hospital, DiaLog Service, CED Service, Ärtzekammer Niedersachsen, St Josef Hospital, Limbach Grupe SE, SUMIT OZFORD, EUMDEICA Kit Kongress, Tillots Pharma, Helios Lkiniken, Lahn-Dill-Kliniken, and Gilead. MHW has research support from Almirall, Da Volterra, EnteroBiotix, GlaxoSmithKline (GSK), Merck, MicroPharm, Nabriva, Paratek, Pfizer, Seres Therapeutics, Summit Therapeutics, The European Tissue Symposium, Tillotts, IMI2 (EU Horizon 2020), and EFPIA partners; has accepted consulting fees from AiCuris, Bayer, Crestone, Da Volterra, Deinove, Destiny Pharma, EnteroBiotix, The European Tissue Symposium, Ferring, GSK, Menarini, Merck, Nestlé, Paion, Paratek, Pfizer, Phico Therapeutics, Qpex Biopharma, Seres, Surface Skins, Summit, Tillotts, and Vaxxilon/Idorsia; and has accepted speakers honoraria from Merck, Pfizer, Seres, and Tillotts. ERD is funded by grants from Synthetic Biologics and Ferring Pharmaceuticals and has accepted consulting fees from Pfizer, Merck, Ferring Pharmaceuticals, Abbott, GSK, Seres Therapeutics, and Summit Therapeutics. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Objectives: We sought to evaluate the safety and effectiveness of fecal microbiota transplantation (FMT) for recurrent Clostridioides difficile infection (CDI) in pediatric immunocompromised (IC) patients., Methods: This is a multicenter retrospective cohort study of pediatric participants who underwent FMT between March 2013 and April 2020 with 12-week follow-up. Pediatric patients were included if they met the definition of IC and were treated with FMT for an indication of recurrent CDI. We excluded patients over 18 years of age, those with incomplete records, insufficient follow-up, or not meeting study definition of IC. We also excluded those treated for Clostridioides difficile recurrence without meeting the study definition and those with inflammatory bowel disease without another immunocompromising condition., Results: Of 59 pediatric patients identified at 9 centers, there were 42 who met inclusion and no exclusion criteria. Included patients had a median age of 6.7 years. Etiology of IC included: solid organ transplantation (18, 43%), malignancy (12, 28%), primary immunodeficiency (10, 24%), or other chronic conditions (2, 5%). Success rate was 79% after first FMT and 86% after 1 or more FMT. There were no statistically significant differences in patient characteristics or procedural components when patients with a failed FMT were compared to those with a successful FMT. There were 15 total serious adverse events (SAEs) in 13 out of 42 (31%) patients that occurred during the follow-up period; 4 (9.5%) of which were likely treatment-related. There were no deaths or infections with multidrug resistant organisms during follow-up and all patients with a SAE fully recovered., Conclusions: The success rate of FMT for recurrent CDI in this pediatric IC cohort is high and mirrors data for IC adults and immunocompetent children. FMT-related SAEs do occur (9.5%) and highlight the need for careful consideration of risk and benefit., Competing Interests: The authors report no conflicts of interest., (Copyright © 2023 by European Society for European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.)

Competing Interests: S.A.K. reports no conflicts of interest.

Many reports pertaining to burns from e-cigarette battery explosions exist, as do injuries from smoking conventional cigarettes while on home-oxygen therapy. However, literature regarding burn injuries from e-cigarettes while on oxygen therapy is limited. The heating coil of the device can rise to temperatures that facilitates ignition of oxygen. The purpose of this study is to describe and characterize this novel and under-reported mechanism of injury. This study was a descriptive review of 2013-2016 National Burn Repository (NBR) data, with a query for "oxygen," "O2," "electronic cigarettes," and various permutations/abbreviations/misspellings. Demographics, injury characteristics, and outcomes were reported. Also, a Google search for lay-press articles and a PubMed/Scopus search using similar terms was conducted to find literature. Of approximately 60,000 NBR entries, 8 records of injury while smoking e-cigarettes on oxygen were found. Patients were predominantly male, 63 ± 9 years old, with 3.4% ± 4 TBSA burns, and LOS of 5.8 ± 7 days (an LOS O/E ratio of 1.5). Two patients sustained full-thickness burns (0.5% and 11% TBSA). Three were intubated, with mean of 3.33 ventilator-days. Most injuries occurred at home (88%). All patients survived. A google search revealed five lay-press articles. Only three partially relevant scientific articles were found to only mention the phenomenon, without granular data. Although uncommon, smoking e-cigarettes on supplemental oxygen can result in injury without a lithium-ion battery explosion. Limitations in the database may have resulted in underestimation of injuries. A paucity of relevant literature exists, necessitating more research. Patients who receive home-O2 should be warned about this potential danger., (© The Author(s) 2023. Published by Oxford University Press on behalf of the American Burn Association. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Fecal microbiota transplantation (FMT) is a rapidly growing therapy aimed at reconstituting the dysbiotic microbiota of a patient with the beneficial stool microbiota of a healthy individual. The efficacy rates of FMT are very robust for recurrent Clostridioides difficile infection in both children and adults. Although complications of FMT have been reported, it is generally believed to be a safe procedure. Novel indications for FMT are being studied, with the hope that ultimately it may be useful for a variety of disorders. As this field continues to grow, however, it is necessary to consider efficacy, safety, and innovation across the lifespan. There are unique concerns regarding FMT as it pertains to children, adults, and the elderly. In this review, we seek to update clinicians, researchers, and regulators on how these factors must be balanced across the lifespan as we move forward with this innovative therapy., (Copyright © 2023 by The American College of Gastroenterology.)

Objectives: To compare the incidence, epidemiology, testing patterns, treatment, and outcomes of Clostridioides difficile infection (CDI) among hospitalized pediatric patients from 2013 to 2019., Study Design: The Pediatric Health Information System database was queried for patient admissions (age 0-17 years) with International Classification of Diseases, 9th and 10th edition, codes for diagnoses of CDI with a billing code for a CDI-related antibiotic treatment., Results: We identified 17 142 pediatric patients, representing 23 052 admissions, with CDI. The adjusted annual CDI incidence decreased over the study period from 7.09 cases per 10 000 patient-days (95% CI, 6.15-8.18) in 2013 to 4.89 cases per 10 000 patient-days (95% CI, 4.03-5.93) in 2019 (P < .001). C difficile-specific testing also decreased during the study period (P < .001). Chronic gastrointestinal conditions (36%) and malignancy (32%) were the most common comorbidities in CDI encounters. Oral metronidazole use decreased during the study period (P < .01) and oral vancomycin use increased (P < .001)., Conclusions: Our study demonstrates a decrease in CDI incidence in hospitalized pediatric patients, a notable change from prior studies, although this may have been influenced by altered testing patterns. We found a high incidence of CDI in patients with cancer and gastrointestinal conditions: groups that warrant targeted evaluation of CDI prevention and treatment., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Increasingly, in the United States, the prescribing of high-cost drugs has become a challenge for physicians and other practitioners. Such drugs are highly regulated by third-party payers (aka insurance), as well as pharmacy benefit managers. Not infrequently, a clinician prescribing a medication will have the payment for the prescription denied by the third-party payer, with the end result being a delay in getting a medically necessary medication to a patient. This article highlights the challenges involved in the prior authorization and denial process, with a focus on pediatric inflammatory bowel disease. The article reviews the role of pharmacy benefits managers in restricting access to drugs, and the reasons why denials of medically necessary medications may occur. The article also provides information on how to appeal denials, how to write a letters of medical necessity, and how to conduct a proper peer-to-peer review. Advocacy from patients and clinicians will be important, as we want to reform the process in the future., Competing Interests: In the last 3 years, Dr Bousvaros has served as a consultant to Takeda, Eli Lilly, and Best Doctors. He has been a site or coinvestigator investigator on protocols sponsored by Prometheus, Janssen, Abbvie, Pfizer, Takeda, Buhlmann, Arena, Eli Lilly, Bristol Myers Squibb, PROCISE diagnostics. Dr Kahn reports no conflicts of interest., (Copyright © 2022 by European Society for European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.)

Background & Objectives: Cyanide poisoning can occur due to exposure to smoke in closed-space fires. With no point of care cyanide test at the scene of a fire, first responders and clinicians base decisions to treat with cyanide antidote on patient history, clinical signs, and other indirect data points that have not been proven to correspond with actual systemic levels of cyanide. The aim of this exploratory study was to determine the economic implications of treating patients with known or suspected cyanide poisoning due to smoke inhalation with hydroxocobalamin., Methods: A decision analysis model was developed from the US hospital perspective. Healthcare resource utilization was estimated from a retrospective evaluation of clinical outcomes in hydroxocobalamin-treated patients and in historical controls without hydroxocobalamin use (Nguyen, et al. 2017). Epidemiologic parameters and costs were estimated from the published literature, and publicly-available hospital charges were identified. Outcomes reported in the analysis included expected healthcare resource utilization in the US population and per-patient costs with and without the use of hydroxocobalamin. A cost-to-charge ratio was applied so that all costs would reflect hospital costs rather than hospital charges. Deterministic sensitivity analysis was performed to identify the most influential model parameters. All costs were reported in 2017 US dollars., Results: Use of hydroxocobalamin reduces healthcare resource utilization and contributes to decreased per-patient hospital costs ($15,381 with hydroxocobalamin treatment versus $22,607 with no cyanide antidote). The most substantive cost-savings resulted from decreased hospital length of stay (i.e., intensive care unit [ICU] and non-ICU). Costs attributed to mechanical ventilation also decreased with use of hydroxocobalamin. A univariate sensitivity analysis demonstrated that the most impactful variables in the cost analysis were related to hospital length of stay (ICU followed by non-ICU stay), followed by the daily cost of ICU stay., Conclusions: Use of hydroxocobalamin in patients with known or suspected cyanide poisoning from closed-space fire smoke inhalation may decrease hospital costs and contribute to more efficient healthcare resource utilization., Competing Interests: Conflict of interest statement This study was sponsored by Pfizer. Jennifer M. Stephens and Jyoti Aggarwal are employees of Open Health who were paid consultants to Pfizer in connection with this study. Jennifer M Stephens owns Open Health stock. Steven N. Michalopoulos was an employee of Open Health during the time of the research and was a paid consultant to Pfizer in connection with this study. Steven A. Kahn was an employee of University of South Alabama Medical Center, Arnold Luterman Regional Burn Center during the time of the research and is now an employee at the Medical University of South Carolina, and was a consultant to Pfizer in connection with this study. Donna Dalton is an employee of Syneos Health who was a paid contractor to Pfizer in connection with this study. Kafi N. Sanders is an employee of Pfizer and Drew E. Lewis was an employee of Pfizer/Viatris at the time of research and manuscript writing. Presented in part at American College of Emergency Physicians, October 2017., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Children with inflammatory bowel disease [IBD] are disproportionally affected by recurrent Clostridioides difficile infection [rCDI]. Although faecal microbiota transplantation [FMT] has been used with good efficacy in adults with IBD, little is known about outcomes associated with FMT in paediatric IBD., Methods: We performed a retrospective review of FMT at 20 paediatric centres in the USA from March 2012 to March 2020. Children with and without IBD were compared with determined differences in the efficacy of FMT for rCDI. In addition, children with IBD with and without a successful outcome were compared with determined predictors of success. Safety data and IBD-specific outcomes were obtained., Results: A total of 396 paediatric patients, including 148 with IBD, were included. Children with IBD were no less likely to have a successful first FMT then the non-IBD affected cohort [76% vs 81%, p = 0.17]. Among children with IBD, patients were more likely to have a successful FMT if they received FMT with fresh stool [p = 0.03], were without diarrhoea prior to FMT [p = 0.03], or had a shorter time from rCDI diagnosis until FMT [p = 0.04]. Children with a failed FMT were more likely to have clinically active IBD post-FMT [p = 0.002] and 19 [13%] patients had an IBD-related hospitalisation in the 3-month follow-up., Conclusions: Based on the findings from this large US multicentre cohort, the efficacy of FMT for the treatment of rCDI did not differ in children with IBD. Failed FMT among children with IBD was possibly related to the presence of clinically active IBD., (© The Author(s) 2021. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objective To examine the relationship between perceived effect of inflammatory bowel diseases (IBD) on high school academics and college planning on college adjustment. Participants: Participants (N = 97) were college students with IBD. Methods: Participants completed an online survey including the Student Adaptation to College Questionnaire and study-developed questions assessing the perceived impact of their diagnosis on their high school academics and college planning. Results: Most participants reported average college adjustment across domains, except personal-emotional adjustment with 47% of participants falling within the very low to low ranges. Nearly half reported IBD impacted their choice of college (49%). The impact of IBD on college planning was most consistently associated with domains of college adjustment. Conclusions: IBD severely impacts college planning, decision-making, and adjustment in college-bound youth. Perceiving that having a chronic illness impacts college planning may result in greater difficulty with academic adjustment, attachment to the institution, and social adjustment during college.

Competing Interests: The authors report no conflicts of interest.

With the rising rates of Clostridioides (Clostridium) difficile infection (CDI) in children, recognizing the limitations of CDI-directed antibiotic therapy, especially in recurrent CDI (rCDI), is important. Fecal microbiota transplantation (FMT), which directly targets the underlying gut dysbiosis present in rCDI, is an important treatment option to consider in rCDI. This article will summarize indications, procedures, effectiveness, and the safety of FMT for rCDI in pediatric patients. [ Pediatr Ann. 2021;50(12):e515-e521.] .

Abstract: Fecal microbiota transplantation (FMT) is currently the most effective but loosely regulated therapy, for recurrent Clostridioides difficile infection (rCDI) in pediatrics. Over the last 2 years, there have been mounting challenges in the ability to provide FMT to pediatric patients. Firstly, an Food and Drug Administration (FDA) safety alert in 2019 reported transmission of a multidrug resistant organism from FMT donor to recipient resulting in the death of 1 patient. Secondly, the coronavirus disease 2019 (COVID-19) pandemic induced further safety and regulatory challenges. Biotherapeutics are promising and more readily regulated treatment options for rCDI, which may replace FMT in the near future for adults upon regulatory agency approvals. Such approvals, however, are expected to be significantly delayed for children, raising concerns for limited access to effective treatment for children with rCDI. In this commentary, we discuss the recent challenges and future directions of FMT and microbial therapeutics in children with rCDI., Competing Interests: The authors report no conflicts of interest., (Copyright © 2021 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.)

Introduction: The impact of the 2019 US Food and Drug Administration safety alert involving transmission of multidrug resistant organisms through fecal microbiota transplantation (FMT), and the COVID-19 pandemic on the use of FMT in children, is unknown., Methods: A survey of pediatric gastroenterologists performing FMT for Clostridioides difficile infection was conducted., Results: Of 36 respondents, 17 (47%) and 30 (83%) changed their FMT practices related to the US Food and Drug Administration safety alert and COVID-19 pandemic, respectively, with 22 (61%) of programs halted., Discussion: The US Food and Drug Administration safety alert and COVID-19 pandemic have substantially influenced the availability and access of FMT for children., (Copyright © 2021 by The American College of Gastroenterology.)

Herpes simplex virus (HSV) is common in the population and reactivation of latent infection often occurs in times of physiologic stress, including postburn injury. Active HSV infection complicates burn injury recovery and increases morbidity. A retrospective chart review of high-risk burn patients (≥20%TBSA and/or facial burns) who had screening HSV immunoglobulin titers drawn from 2015 to 2018 was conducted. Titer levels and morbidity-related outcomes were compared between patients who developed active infection and those who did not. Fifty-six patients had serum HSV titers measured. Twenty-nine patients (52%) developed clinical signs of HSV infection, almost all of which (97%) suffered facial burns. Titers were ordered on median hospital day 1.5 (0.00-4.0) and infection occurred on day 8.0 (2.0-16). Median HSV-1,2 IgM titers were significantly increased in patients who developed clinically active HSV infection (0.71 [0.44-1.1] vs 0.52 [0.34-0.74], P = .02). Median HSV-1 IgG (P = .65) and HSV-2 IgG titers (P = .97) were not different between groups. Patients who developed active infection had a comparable hospital length of stay (27 [9.5-40] days vs 20 [8.0-28] days, P = .17) and ICU length of stay (26 [13-49] days vs 19 [11-27] days, P = .09) to those who did not develop infection. There was no difference in mortality. Increased HSV-1 and 2 IgM screening levels were associated with an increased risk of developing active HSV infection, and offer a specific screening modality in high-risk patients. Elevated IgM titers warrant further consideration for administration of HSV prophylaxis, as earlier intervention may prevent infection onset and minimize morbidity., (© The Author(s) 2021. Published by Oxford University Press on behalf of the American Burn Association. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: Burn injury and reconstructive operations often result in severe pain, particularly at skin graft donor sites. Traditional local anesthetics administered intraoperatively control pain at donor sites, but the duration of action is short. Liposomal bupivacaine, a novel local anesthetic, can provide sustained-release analgesia for 72h. The primary aim of this study was to describe the efficacy of liposomal bupivacaine for postoperative donor site pain control for patients undergoing skin graft procedures., Methods: A retrospective cohort study was performed on patients who received a donor site liposomal bupivacaine field block and was compared to a matched control. Patients rated donor site pain on post-operative day 0 and 1, and stated whether the donor or graft site was more painful., Results: Fifty-eight patients were included. Twenty-nine patients received liposomal bupivacaine. Eighty-six percent of patients in the treatment group rated donor site pain as three or less on postoperative day 0 and 1, compared to 3.4% in the control (p<0.0001). Also, 76% of patients in the treatment group stated donor site pain was less than graft site pain, compared to 3.4% in the control (p<0.0001)., Conclusion: Patients who received liposomal bupivacaine reported less postoperative donor site pain and found the donor site to be less bothersome without major complications. Liposomal bupivacaine may be a safe and promising agent for prolonging postoperative analgesia and minimizing donor site pain., (Copyright © 2020. Published by Elsevier Ltd.)

Background: As the reliability of fecal calprotectin (Fcal) remains debatable to detect endoscopic ulcerations in patients with pure ileal Crohn's disease (CD), we aimed to compare its performances with those observed in patients with colonic or ileocolonic location., Methods: Using a prospectively maintained database, we analyzed 123 CD patients with Fcal measurement and ileocolonoscopy performed within 1 month with no therapeutic intervention during this interval. Receiver operating characterstic curves (ROC) were used to determine the best Fcal threshold to detect endoscopic ulcerations, taking into account the clinical relevance and usual recommended indices. Sensitivity, specificity, and positive (PPV) and negative predictive values (NPV) were presented with 95% confidence intervals., Results: The mean Fcal level was significantly higher in patients with endoscopic ulcerations in the L1 group (P = 0.025) and the L2-L3 group (P < 0.001). Using ROC curves, Fcal >200 µg/g and Fcal >250 µg/g were the best thresholds to detect endoscopic ulcerations in the L1 group (sensitivity = 75.0, 95% CI, 47.6-92.7; specificity = 87.5, 95% CI, 67.6-97.3; PPV = 80.0, 95% CI, 51.9-95.7; and NPV = 84.0; 95% CI, 63.9-95.5) and in the L2-L3 group (sensitivity = 84.1 95% CI, 69.9-93.4; specificity = 74.4, 95% CI, 57.9-87.0; PPV = 78.7, 95% CI, 64.3-89.3, and NPV = 80.6, 95% CI, 64.0-91.8), respectively. We compared the AUC between L1 and L2-L3 groups, and no difference was shown (0.89 vs 0.84, respectively, P = 0.46). We also compared 2-by-2 sensitivity, specificity, PPV, NPV, and accuracy and we did not observe any significant difference., Conclusion: Fecal calprotectin is highly effective to detect endoscopic ulcerations regardless of CD location but requires a lower cutoff value in patients with pure ileal involvement., (© 2020 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Providing adequate analgesia during burn wound care is essential to patient-centered care. Both oral and intravenous (IV) ketamine are often used for analgesia and sedation. Ketamine may improve analgesia and decrease opioid requirements for burn wound care. Oral ketamine wafers and tablets have been used as a safe alternative internationally but are unavailable in the United States. The purpose of this study was to compare opioid usage and patient satisfaction scores in patients with and without the use of oral injectable ketamine for burn wound care, with each patient serving as their own control. Ketamine, opioid, and benzodiazepine dosages recorded during dressing changes were compared to dressing changes without ketamine use that occurred before and after ketamine-associated sessions in each patient. Fourteen patients received oral ketamine at a median (interquartile range [IQR]) dose of 2.5 (2.2-2.7) mg/kg. Ketamine use significantly decreased opioid requirements when compared to wound care sessions that did not use ketamine both before (50 [IQR: 30-75] mg vs 75 [IQR: 46-91] mg median IV morphine equivalents, P = .0097) and after (50 [IQR: 30-75] mg vs 63 [IQR: 50-96] mg median IV morphine equivalents, P = .0042) the ketamine-associated sessions. One patient experienced hallucinations, and no adverse events were observed. Hence, oral administration of injectable ketamine was associated with a decrease in opioid requirements during dressing changes. Additionally, ketamine use improved patient satisfaction ( P = .0034). Preliminary data suggest this promising analgesia method is safe and effective for burn wound care.

Objective: To report experience with fecal microbiota transplantation (FMT) for recurrent Clostridioides difficile infection (rCDI) and provide recommendations for management of rCDI and donor testing during the COVID-19 pandemic., Methods: A retrospective study of patients with rCDI who underwent FMT from May 26, 2020, to September 30, 2020, with stool from well-screened donors with health and infectious screening and a newly implemented strategy for COVID-19 screening with every 2-week bookend testing with stool quarantine. Patients were followed up for development of rCDI and COVID-19., Results: Of the 57 patients who underwent FMT for rCDI, 29 were tested for COVID-19 via nasopharyngeal polymerase chain reaction (PCR) and 22 via serology. All results were negative, except for 1 positive serology. Donor testing every 2 weeks for COVID-19 via serology and nasopharyngeal swab PCR was negative, except for 2 donors at 1 center who were excluded. Three patients had rCDI after FMT, and 1 underwent repeat FMT. One patient developed respiratory symptoms suggestive of COVID-19 and tested negative via nasopharyngeal PCR. Eleven patients who underwent COVID-19 testing for elective procedures or hospitalizations tested negative. No SARS-CoV-2 transmission was noted., Conclusions: With appropriate donor screening, FMT can be performed safely for rCDI during the COVID-19 pandemic. Development of a validated stool assay for SARS-CoV-2 will simplify this process further., (Copyright © 2021 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Coronavirus disease 2019 is associated with a postinfectious multisystem inflammatory syndrome in children (MIS-C). This syndrome is marked by cytokine storm and multiorgan dysfunction, often affecting the gastrointestinal tract, the heart, and the hematopoietic system. We describe the case of a 16-year-old boy with an initial presentation of severe inflammatory bowel disease and concurrent MIS-C. He presented with abdominal pain, diarrhea, and hematochezia and met criteria for the systemic inflammatory response syndrome. Laboratory inflammatory profiling revealed markedly elevated ferritin, D-dimer, C-reactive protein, soluble interleukin 2, and interleukin 6 levels. Endoscopy and colonoscopy revealed severe active gastroduodenitis, patchy colitis, and a normal-appearing terminal ileum. The patient was treated with a combination of steroids, intravenous immunoglobulin, and infliximab, and his symptoms slowly resolved over a 3-week period. In this case, we describe coincident MIS-C with a remarkably severe and difficult-to-treat initial presentation of inflammatory bowel disease and highlight the need to investigate the effect of coronavirus disease 2019 and MIS-C on inflammatory disorders., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2021 by the American Academy of Pediatrics.)

Background & Aims: Fecal microbiota transplantation (FMT) is used commonly for treatment of Clostridioides difficile infections (CDIs), although prospective safety data are limited and real-world FMT practice and outcomes are not well described. The FMT National Registry was designed to assess FMT methods and both safety and effectiveness outcomes from North American FMT providers., Methods: Patients undergoing FMT in clinical practices across North America were eligible. Participating investigators enter de-identified data into an online platform, including FMT protocol, baseline patient characteristics, CDI cure and recurrence, and short and long-term safety outcomes., Results: Of the first 259 participants enrolled at 20 sites, 222 had completed short-term follow-up at 1 month and 123 had follow-up to 6 months; 171 (66%) were female. All FMTs were done for CDI and 249 (96%) used an unknown donor (eg, stool bank). One-month cure occurred in 200 patients (90%); of these, 197 (98%) received only 1 FMT. Among 112 patients with initial cure who were followed to 6 months, 4 (4%) had CDI recurrence. Severe symptoms reported within 1-month of FMT included diarrhea (n = 5 [2%]) and abdominal pain (n = 4 [2%]); 3 patients (1%) had hospitalizations possibly related to FMT. At 6 months, new diagnoses of irritable bowel syndrome were made in 2 patients (1%) and inflammatory bowel disease in 2 patients (1%)., Conclusions: This prospective real-world study demonstrated high effectiveness of FMT for CDI with a good safety profile. Assessment of new conditions at long-term follow-up is planned as this registry grows and will be important for determining the full safety profile of FMT., (Copyright © 2021. Published by Elsevier Inc.)

Burn care and medical education have undergone dramatic changes. Trauma has over seven courses covering fundamentals, whereas burns has one. Our goal was to develop a course to meet the needs of healthcare professionals requiring more advanced burn management training. A survey was distributed to burn physicians, nurses, therapists, administrators, and survivors, to assess the perceived proficiency of those managing adult and pediatric patients. Procedure simulators were developed, and a course was designed and delivered. An after-course survey of participants captured how this course filled identified knowledge gaps. A total of 188 initial surveys were sent to individuals involved in burn care. A diverse pool of 109 individuals participated (58% response rate). Survey results by providers demonstrated the lowest self-rated proficiency scores at managing large pediatric burns and frostbite. Nonphysicians reported low proficiency in developing wound treatment algorithms, performing escharotomies, and aftercare/reintegration. Following rigorous curriculum development, the course was conducted, and after-course surveys noted students' improved understanding of managing burn injuries, ability to troubleshoot, confidence to manage patients, and their recommending the course to a peer. Providing quality care beyond the initial assessment and stabilization of a burn-injured patient requires additional skills and knowledge. Providers that are uncomfortable or challenged in providing this care may benefit from additional training. Initial data show that a course, such as this one, provides the education necessary to fill the most commonly reported gaps in knowledge and skills. Further work is being invested to develop disaster management skills, assessment components, and further determine course validity., (© The Author(s) 2020. Published by Oxford University Press on behalf of the American Burn Association. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Severe burn injury requires significant volume resuscitation, but over-resuscitation can be deadly. Accurate resuscitation of obese patients is challenging due to the decreased vascularity of adipose tissue. This study compares an adjusted ideal body weight index formula with fresh frozen plasma rescue to historical controls resuscitated with Parkland-based resuscitation. A retrospective review was conducted of adult patients admitted to our regional burn center with ≥ 20% total body surface area (TBSA) burns from 2010 to 2017 who survived more than 48 hours. Historical controls were resuscitated with Parkland-based resuscitation with occasional albumin. The adjusted ideal body weight (AIBW) patients were resuscitated with 2-4 mL/kg/%TBSA using an adjusted ideal body weight with fresh frozen plasma (FFP) rescue. Outcomes were compared with nonparametric statistics. A total of 161 patients met inclusion criteria: 40 patients received AIBW resuscitation and 121 patients were included as controls. The AIBW group received less fluid (3.30 vs. 4.15 mL/kg/%TBSA, p<0.001). A significant reduction in acute kidney injury requiring dialysis in the AIBW group was appreciated (5% vs. 19%, p=0.03) with improved mortality in AIBW patients as well (5% vs. 20%, p=0.03). Using an adjusted ideal body weight with FFP rescue to resuscitate patients with severe burn injury leads to a significant reduction in fluid administration without increase in acute kidney injury requiring dialysis and with improved mortality., (Copyright © 2020 Euro-Mediterranean Council for Burns and Fire Disasters.)

Intro: There were over 60 firefighter line of duty deaths and roughly 30,000 injuries in the United States in 2016. Modern thermoprotective gear has reduced the risks firefighters face from both thermal and inhalation injury, but must be used properly to be effective. The purpose of this study is to examine gear use and associated injury in firefighters., Methods: Surveys were distributed with questions about demographics, gear usage, and maintenance practices. If previously injured, firefighters described the injury, treatment, and recovery., Results: Of the 50 surveys distributed, 37 were returned (72%). A majority of respondents (70%) reported wearing incomplete gear. Those who reported injury were more likely to have omitted gear (81% vs 45%). For all respondents, the items most commonly omitted were hood (58%), gloves (22%), and earflaps (22%). Regular cleaning of gear was not practiced by 39% of burned respondents and 46% had not had their gear sized within 2 years. Serious burns were reported by 41% of respondents. Mean burn size was 7% total body surface area (TBSA), and 11% reported self-treating their burns, including 63.5% who continued to work despite suffering a 2nd or 3rd degree burn injury. Only 17% were treated at a burn center, and this group missed anywhere from two shifts to 8 months of work., Conclusions: Firefighters risk injury by omitting gear and not adhering to National Fire Protection Association (NFPA) guidelines on gear sizing, maintenance, and station wear. Firefighters also frequently self-treat serious burns despite unique considerations regarding re-injury. National trends related to gear use and injury risk should be studied further, and standards should be developed for ensuring safe return to work., (Copyright © 2019 Elsevier Ltd and ISBI. All rights reserved.)

Background & Aims: Fecal microbiota transplantation (FMT) is commonly used to treat Clostridium difficile infection (CDI). CDI is an increasing cause of diarrheal illness in pediatric patients, but the effects of FMT have not been well studied in children. We performed a multi-center retrospective cohort study of pediatric and young adult patients to evaluate the efficacy, safety, and factors associated with a successful FMT for the treatment of CDI., Methods: We performed a retrospective study of 372 patients, 11 months to 23 years old, who underwent FMT at 18 pediatric centers, from February 1, 2004, to February 28, 2017; 2-month outcome data were available from 335 patients. Successful FMT was defined as no recurrence of CDI in the 2 months following FMT. We performed stepwise logistic regression to identify factors associated with successful FMT., Results: Of 335 patients who underwent FMT and were followed for 2 months or more, 271 (81%) had a successful outcome following a single FMT and 86.6% had a successful outcome following a first or repeated FMT. Patients who received FMT with fresh donor stool (odds ratio [OR], 2.66; 95% CI, 1.39-5.08), underwent FMT via colonoscopy (OR, 2.41; 95% CI, 1.26-4.61), did not have a feeding tube (OR, 2.08; 95% CI, 1.05-4.11), or had 1 less episode of CDI before FMT (OR, 1.20; 95% CI, 1.04-1.39) had increased odds for successful FMT. Seventeen patients (4.7%) had a severe adverse event during the 3-month follow-up period, including 10 hospitalizations., Conclusions: Based on the findings from a large multi-center retrospective cohort, FMT is effective and safe for the treatment of CDI in children and young adults. Further studies are required to optimize the timing and method of FMT for pediatric patients-factors associated with success differ from those of adult patients., (Copyright © 2020 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Although faecal microbiota transplantation (FMT) has a well-established role in the treatment of recurrent Clostridioides difficile infection (CDI), its widespread dissemination is limited by several obstacles, including lack of dedicated centres, difficulties with donor recruitment and complexities related to regulation and safety monitoring. Given the considerable burden of CDI on global healthcare systems, FMT should be widely available to most centres.Stool banks may guarantee reliable, timely and equitable access to FMT for patients and a traceable workflow that ensures safety and quality of procedures. In this consensus project, FMT experts from Europe, North America and Australia gathered and released statements on the following issues related to the stool banking: general principles, objectives and organisation of the stool bank; selection and screening of donors; collection, preparation and storage of faeces; services and clients; registries, monitoring of outcomes and ethical issues; and the evolving role of FMT in clinical practice,Consensus on each statement was achieved through a Delphi process and then in a plenary face-to-face meeting. For each key issue, the best available evidence was assessed, with the aim of providing guidance for the development of stool banks in order to promote accessibility to FMT in clinical practice., Competing Interests: Competing interests: JRA received grants from, and consulted for, Finch Therapeutics and Merck and Co. GC, GI, FS and LM received grants in the field of faecal microbiota transplantation (FMT) from the Italian Ministry of Health. SPC received fees from Shire, Ferring, Microbiotica, Pfizer and Janssen. MF is consultant to Finch Therapeutics Group and DSMB member for Rebiotix. AH has served as consultant, advisory board member or speaker for AbbVie, Atlantic, Bristol-Myers Squibb, Celltrion, Falk, Ferring, Janssen, MSD, Napp Pharmaceuticals, Pfizer, Pharmacosmos, Shire and Takeda; she also serves on the Global Steering Committee for Genentech. ZK is an employee/shareholder at Finch Therapeutics and advisor/consultant at OpenBiome. JK and EJK received research grants from Vedanta Bioscences, Boston, USA. CPK is a clinical site for the PRISM FMT trial conducted by Finch Therapeutics. HS received unrestricted study grants: Danone, Biocodex, Enterome; board membership, consultancy or lecture fees: Carenity, Abbvie, Astellas, Danone, Ferring, Mayoly Spindler, MSD, Novartis, Roche, Tillots, Enterome, Maat, BiomX, Biose, Novartis, Takeda; co-funder of Exeliom Biosciences. All the remaining authors have nothing to declare., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims: To assess faecal calprotectin [Fcal] levels before and after therapeutic de-escalation, to predict clinical relapse in patients with inflammatory bowel disease [IBD]., Methods: From a prospectively maintained database, we enrolled 160 IBD patients [112 Crohn's disease/48 ulcerative colitis] in clinical remission, with Fcal measured within 8 weeks before therapeutic de-escalation. Clinical relapse was defined using the Harvey-Bradshaw index or Simple Clinical Colitis Activity Index., Results: Using a receiver operating characteristic [ROC] curve, Fcal >100 µg/g was the best threshold to predict clinical relapse after therapeutic de-escalation (area under the curve [AUC] = 0.84). In multivariate analysis, clinical remission >6 months before therapeutic de-escalation (hazard ratio [HR] = 0.57 [0.33-0.99]; p = 0.044) was associated with decreased risk of relapse, whereas current steroid medication ( = 1.67[1.00-2.79]; p <0.0001) was a risk factor. Fcal >100 µg/g was predictive of clinical relapse (HR = 3.96 [2.47-6.35]; p < 0.0001) in the whole cohort but also in patients receiving anti-tumour necrosis factor [TNF] agents [n = 85 patients; p <0.0001], anti-integrins [n = 32; p = 0.003], or no biologics [n = 43; p = 0.049], or attempting to discontinue steroids [n = 37; p = 0.001]. One patient [1/98] and seven patients [7/88, 8.0%] with baseline Fcal <100 µg/g relapsed within 3 months and 6 months after therapeutic de-escalation, respectively. A total of 74 Fcal measurements were performed in 52 patients after therapeutic de-escalation. Monitoring Fcal >200 µg/g [ROC curve with AUC = 0.96] was highly predictive of clinical relapse in multivariate analysis ([HR = 31.8 [3.5-289.4], p = 0.002). Only two relapses [2/45, 4.4%] occurred within 6 months while Fcal <200 µg/g., Conclusions: Fcal level is highly accurate to predict and monitor the risk of relapse after therapeutic de-escalation in IBD patients and could be used in daily practice., (Copyright © 2019 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)