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OBJECTIVE The goal of this study was to assess the social determinants that influence access and outcomes for pediatric neurosurgical care for patients with Chiari malformation type I (CM-I) and syringomyelia (SM). METHODS The authors used retro- and prospective components of the Park-Reeves Syringomyelia Research Consortium database to identify pediatric patients with CM-I and SM who received surgical treatment and had at least 1 year of follow-up data. Race, ethnicity, and insurance status were used as comparators for preoperative, treatment, and postoperative characteristics and outcomes. RESULTS A total of 637 patients met inclusion criteria, and race or ethnicity data were available for 603 (94.7%) patients. A total of 463 (76.8%) were non-Hispanic White (NHW) and 140 (23.2%) were non-White. The non-White patients were older at diagnosis (p = 0.002) and were more likely to have an individualized education plan (p < 0.01). More non-White than NHW patients presented with cerebellar and cranial nerve deficits (i.e., gait ataxia [p = 0.028], nystagmus [p = 0.002], dysconjugate gaze [p = 0.03], hearing loss [p = 0.003], gait instability [p = 0.003], tremor [p = 0.021], or dysmetria [p < 0.001]). Non-White patients had higher rates of skull malformation (p = 0.004), platybasia (p = 0.002), and basilar invagination (p = 0.036). Non-White patients were more likely to be treated at low-volume centers than at high-volume centers (38.7% vs 15.2%; p < 0.01). Non-White patients were older at the time of surgery (p = 0.001) and had longer operative times (p < 0.001), higher estimated blood loss (p < 0.001), and a longer hospital stay (p = 0.04). There were no major group differences in terms of treatments performed or complications. The majority of subjects used private insurance (440, 71.5%), whereas 175 (28.5%) were using Medicaid or self-pay. Private insurance was used in 42.2% of non-White patients compared to 79.8% of NHW patients (p < 0.01). There were no major differences in presentation, treatment, or outcome between insurance groups. In multivariate modeling, non-White patients were more likely to present at an older age after controlling for sex and insurance status (p < 0.01). Non-White and male patients had a longer duration of symptoms before reaching diagnosis (p = 0.033 and 0.004, respectively). CONCLUSIONS Socioeconomic and demographic factors appear to influence the presentation and management of patients with CM-I and SM. Race is associated with age and timing of diagnosis as well as operating room time, estimated blood loss, and length of hospital stay. This exploration of socioeconomic and demographic barriers to care will be useful in understanding how to improve access to pediatric neurosurgical care for patients with CM-I and SM.

OBJECTIVE The condylar–C2 sagittal vertical alignment (C-C2SVA) describes the relationship between the occipitoatlantal joint and C2 in patients with Chiari malformation type I (CM-I). It has been suggested that a C-C2SVA ≥ 5 mm is predictive of the need for occipitocervical fusion (OCF) or ventral brainstem decompression (VBD). The authors’ objective was to validate the predictive utility of the C-C2SVA by using a large, multicenter cohort of patients. METHODS This validation study used a cohort of patients derived from the Park-Reeves Syringomyelia Research Consortium; patients < 21 years old with CM-I and syringomyelia treated from June 2011 to May 2016 were identified. The primary outcome was the need for OCF and/or VBD. After patients who required OCF and/or VBD were identified, 10 age- and sex-matched controls served as comparisons for each OCF/VBD patient. The C-C2SVA (defined as the position of a plumb line from the midpoint of the O–C1 joint relative to the posterior aspect of the C2–3 disc space), pBC2 (a line perpendicular to a line from the basion to the posteroinferior aspect of the C2 body), and clival-axial angle (CXA) were measured on sagittal MRI. The secondary outcome was the need for ≥ 2 CM-related operations. RESULTS Of the 206 patients identified, 20 underwent OCF/VBD and 14 underwent repeat posterior fossa decompression. A C-C2SVA ≥ 5 mm was 100% sensitive and 86% specific for requiring OCF/VBD, with a 12.6% misclassification rate, whereas CXA < 125° was 55% sensitive and 99% specific, and pBC2 ≥ 9 was 20% sensitive and 88% specific. Kaplan-Meier analysis demonstrated that there was a significantly shorter time to second decompression in children with C-C2SVA ≥ 5 mm (p = 0.0039). The mean C-C2SVA was greater (6.13 ± 1.28 vs 3.13 ± 1.95 mm, p < 0.0001), CXA was lower (126° ± 15.4° vs 145° ± 10.7°, p < 0.05), and pBC2 was similar (7.65 ± 1.79 vs 7.02 ± 1.26 mm, p = 0.31) among those who underwent OCF/VBD versus decompression only. The intraclass correlation coefficient for the continuous measurement of C-C2SVA was 0.52; the kappa value was 0.47 for the binary categorization of C-C2SVA ≥ 5 mm. CONCLUSIONS These results validated the C-C2SVA using a large, multicenter, external cohort with 100% sensitivity, 86% specificity, and a 12.6% misclassification rate. A C-C2SVA ≥ 5 mm is highly predictive of the need for OCF/VBD in patients with CM-I. The authors recommend that this measurement be considered among the tools to identify the “high-risk” CM-I phenotype.

OBJECTIVE Posterior fossa decompression with duraplasty (PFDD) is commonly performed for Chiari I malformation (CM-I) with syringomyelia (SM). However, complication rates associated with various dural graft types are not well established. The objective of this study was to elucidate complication rates within 6 months of surgery among autograft and commonly used nonautologous grafts for pediatric patients who underwent PFDD for CM-I/SM. METHODS The Park-Reeves Syringomyelia Research Consortium database was queried for pediatric patients who had undergone PFDD for CM-I with SM. All patients had tonsillar ectopia ≥ 5 mm, syrinx diameter ≥ 3 mm, and ≥ 6 months of postoperative follow-up after PFDD. Complications (e.g., pseudomeningocele, CSF leak, meningitis, and hydrocephalus) and postoperative changes in syrinx size, headaches, and neck pain were compared for autograft versus nonautologous graft. RESULTS A total of 781 PFDD cases were analyzed (359 autograft, 422 nonautologous graft). Nonautologous grafts included bovine pericardium (n = 63), bovine collagen (n = 225), synthetic (n = 99), and human cadaveric allograft (n = 35). Autograft (103/359, 28.7%) had a similar overall complication rate compared to nonautologous graft (143/422, 33.9%) (p = 0.12). However, nonautologous graft was associated with significantly higher rates of pseudomeningocele (p = 0.04) and meningitis (p < 0.001). The higher rate of meningitis was influenced particularly by the higher rate of chemical meningitis (p = 0.002) versus infectious meningitis (p = 0.132). Among 4 types of nonautologous grafts, there were differences in complication rates (p = 0.02), including chemical meningitis (p = 0.01) and postoperative nausea/vomiting (p = 0.03). Allograft demonstrated the lowest complication rates overall (14.3%) and yielded significantly fewer complications compared to bovine collagen (p = 0.02) and synthetic (p = 0.003) grafts. Synthetic graft yielded higher complication rates than autograft (p = 0.01). Autograft and nonautologous graft resulted in equal improvements in syrinx size (p < 0.0001). No differences were found for postoperative changes in headaches or neck pain. CONCLUSIONS In the largest multicenter cohort to date, complication rates for dural autograft and nonautologous graft are similar after PFDD for CM-I/SM, although nonautologous graft results in higher rates of pseudomeningocele and meningitis. Rates of meningitis differ among nonautologous graft types. Autograft and nonautologous graft are equivalent for reducing syrinx size, headaches, and neck pain.

Background and purpose Risk prediction with the Global Registry of Acute Coronary Events (GRACE) risk model is guideline-recommended in acute coronary syndrome (ACS) patients. However, the performance of more contemporary scores derived from ACTION (Acute Coronary Treatment and Intervention Outcomes Network) and National Cardiovascular Data (NCDR) registries remains incompletely understood. We aimed to compare these models in German ACS patients. Methods and results A total of 1567 patients with (Non-)ST-segment elevation myocardial infarction (NSTEMI: 1002 patients, STEMI: 565 patients) undergoing invasive management at University Hospital Dusseldorf (Germany) from 2014 to 2018 were included. Overall in-hospital mortality was 7.5% (NSTEMI 3.7%, STEMI 14.5%). Parameters for calculation of GRACE 1.0, GRACE 2.0, ACTION and NCDR risk models and in-hospital mortality were assessed and risk model performance was compared. The GRACE 1.0 risk model for prediction of in-hospital mortality discriminated risk superior (c-index 0.84) to its successor GRACE 2.0 (c-index 0.79, pGRACE1.0vsGRACE2.0 = 0.0008). The NCDR model performed best in discrimination of risk in ACS overall (c-index 0.89; pACTIONvsNCDR Conclusions In a contemporary German patient population with ACS, modern NCDR and ACTION risk models showed superior performance in prediction of in-hospital mortality compared to the gold-standard GRACE model.

Background Previous research from our center has shown that 27% of the pediatric trauma transfers from referring facilities are potentially preventable. Our hospital is the only level 1 pediatric trauma center (PTC) in our state, and we are developing a pediatric trauma telehealth network to help keep certain injured children closer to home. We instituted a pediatric trauma telehealth program with a partnering community-based hospital in our state and aim to report our experience over the first year. Methods All pediatric trauma patients that presented to our partnering hospital from January 2019 to February 2020 were reviewed. Disposition was: a) telehealth consultation, b) admission to the children's unit without a telehealth consultation per our head trauma protocol, or c) transfer without telehealth consultation. Data on demographics, hospital course, and disposition were collected via chart review. Results Eight patients underwent telehealth consults and another 8 patients were admitted to the partnering hospital's children's unit based on the head trauma protocol without a telehealth consult. Patient's ages ranged from 7 months to 15 years. Of the patients that underwent telehealth consult, 7 presented with a head injury and 1 presented with a rib fracture/small pneumothorax. The patient with a pneumothorax was observed for 6 h and discharged home after a repeat chest x-ray was stable. All 15 patients with head injuries were observed and discharged from either the emergency department or children's unit after passing concussion testing. No patients required transfer to our PTC after observation, and none were readmitted. Fifty-six patients were transferred without telehealth consultation, and 3 of these patients could potentially have avoided transfer with a telehealth consultation. Conclusions Telehealth in pediatric trauma can be a safe mechanism for preventing the transfer of patients that can be safely observed at a partnering hospital. From a facility that transfers an average of 30 trauma patients per year to our hospital, this program prevented 16 such transfers. Development of a head trauma protocol in collaboration with a pediatric neurosurgeon leads to an unexpected number of patients being admitted to the partnering hospital for observation without utilization of a telehealth consultation. Type of study Retrospective study. Level of evidence III

Introduction Since January 2002, pre-deployment training of forward resuscitative and surgical units has taken place at the U.S. Army Trauma Training Center (ATTC) in Miami, FL. In June 2019, the 240th Forward Resuscitative Surgical Team (FRST) conducted the first pre-deployment Surgical Readiness Training Exercise (SURGRETE) in San Pedro Sula, Honduras, to allow the team to rehearse in a resource-constrained environment more similar to that expected on deployment. The purpose of this study is to describe and compare the pre-deployment training experiences of the 240th FRST during their SURGRETE in Honduras and ATTC rotation in Miami, FL. Materials and Methods A descriptive analysis of prospectively collected data was performed for surgical cases, trauma resuscitations, and nonsurgical procedures by the 240th FRST over a 2-week SURGRETE in Honduras and 2-week ATTC rotation in Miami, FL. Items accomplished within the Individual Critical Task Lists (ICTLs) of key clinical providers on the team (general surgeon, orthopedic surgeon, emergency medicine physician, and Certified Registered Nurse Anesthetist) were identified and compared to those accomplished at the ATTC. Results During the SURGRETE in Honduras, 64 surgical cases, 1 trauma resuscitation, 2 Advanced Cardiac Life Support codes, and 213 nonsurgical procedures were performed collectively by the team. During ATTC rotation, the team performed a combined total of 10 surgical cases, 6 trauma resuscitations, and 56 nonsurgical procedures. For each key clinical provider, more of their assigned ICTLs were conducted during the Honduras SURGRETE than during ATTC rotation. The ATTC, however, offered more cases of acute life-threatening trauma. Conclusion Appropriately planned SURGRETEs can provide a concentrated case volume in a resource-constrained setting and challenge the team to consider definitive management algorithms. The cases performed may not necessarily reflect the type and acuity of operations performed in a deployed environment; however, they facilitate repetition of basic skills, team cohesion, and cross-training. The SURGRETE experience could be improved by locating a facility with a trauma-dominant patient population that allows increased autonomy of U.S. physicians.

BACKGROUND: Occipital-cervical fusion (OCF) and ventral decompression (VD) may be used in the treatment of pediatric Chiari-1 malformation (CM-1) with syringomyelia (SM) as adjuncts to posterior fossa decompression (PFD) for complex craniovertebral junction pathology. OBJECTIVE: To examine factors influencing the use of OCF and OCF/VD in a multicenter cohort of pediatric CM-1 and SM subjects treated with PFD. METHODS: The Park-Reeves Syringomyelia Research Consortium registry was used to examine 637 subjects with cerebellar tonsillar ectopia ≥ 5 mm, syrinx diameter ≥ 3 mm, and at least 1 yr of follow-up after their index PFD. Comparisons were made between subjects who received PFD alone and those with PFD + OCF or PFD + OCF/VD. RESULTS: All 637 patients underwent PFD, 505 (79.2%) with and 132 (20.8%) without duraplasty. A total of 12 subjects went on to have OCF at some point in their management (PFD + OCF), whereas 4 had OCF and VD (PFD + OCF/VD). Of those with complete data, a history of platybasia (3/10, P = .011), Klippel-Feil (2/10, P = .015), and basilar invagination (3/12, P

BACKGROUND AND OBJECTIVES STIs present a significant threat to individual and public health, disproportionately affecting youth. The study aimed to evaluate (a) the prevalence of asymptomatic Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections among youth using a rapid assay platform, (b) the participants' sexual behaviour and STI knowledge, (c) the utility of the rapid assay in reducing diagnosis-to-treatment time. METHODS In this study, 272 subjects (14-31 years) were included between 12/2016 and 7/2018. A questionnaire was used to collect sociodemographic data, sexual behaviour and STI knowledge. Prevalence of CT and NG infections were tested from oral, vaginal and anal swabs for women and oral, anal swabs and urine for men, using the Cepheid Xpert® CT/NG assay. Time intervals between (i) test to the time the patient were informed of the result (turn around time - TAT) and (ii) test to therapy initiation was documented. RESULTS Of the 272 subjects (48.9% female, 48.9% male, undisclosed 2.2%), 56.6 % reported university education. 46.6% were men who have sex with men (MSM), and 47.4% of women and 63.1% of men had anal intercourse. 59.9% had previously been tested for HIV, while only 39.7% had for CT, 20.6% for NG. Among these asymptomatic youth 7.7% were positive for CT and 5.5% for NG. The localization of CT were 3.7% genital, 5.5% anal and 2.2% oral, while the corresponding localization of NG were 0.4%, 2.9%, 4.4% respectively. 91.8% of the participants were informed of a positive result within 24 h with a median TAT of 03:09 h. 73.3% initiated therapy within 24 h, with a median time from testing to therapy initiation being 06:50 h. CONCLUSION Asypmtomatic CT and NG infections are common and often not tested in persons at risk. The Cepheid Xpert® CT/NG assay is an effective strategy as it reduces STI diagnosis-to-treatment time to less than a day.

Objectives: Adolescents and young adults account for 50% of new infections with sexually transmitted infection (STI), while representing only 25% of the sexually active population. An evaluation of sexual behavior, STI knowledge and infection among youth of different age groups is relevant to formulate effective sexual health strategies. Methods: In this monocentric, open, prospective cross-sectional study, 268 asymptomatic subjects (14–30 years) were partitioned into three cohorts I: 14–19 (n = 42), II: 20–25 (n = 147) and III: 25-30 (n = 79) years. A comparative analysis of their sexual behavior and STI knowledge was performed using a 21-item questionnaire at the WIR-Center for Sexual Health and Medicine. Prevalence of chlamydia and gonococcal infections were tested, using the Cepheid Xpert® CT/NG assay. Results: The three age-specific cohorts showed statistically significant differences in their relationship status, their sexual contacts and the number of life-time sexual partners. Independent of age, men who have sex with men had greater number of sexual partners across all age groups. Although >95% of participants were aware of HIV in all age groups, the corresponding awareness of non-HIV STI was consistently lower in cohort I. The awareness of trichomonas, mycoplasma and candida in particular was

Anorexia nervosa (AN) is a life‐threatening eating disorder, characterised by persistent pathological weight loss behaviours and an intense fear of weight gain and food consumption. Although there is an abundance of scientific theories on the neurobiological, psychological and sociocultural factors thought to be involved in the maintenance of AN, there is little experimental research testing these ideas. The need for theory firmly grounded in empirical evidence becomes strikingly clear when we consider that current treatments for patients with AN are limited in their effectiveness, and relapse after treatment is common.

OBJECTIVEFactors associated with syrinx size in pediatric patients undergoing posterior fossa decompression (PFD) or PFD with duraplasty (PFDD) for Chiari malformation type I (CM-I) with syringomyelia (SM; CM-I+SM) are not well established.METHODSUsing the Park-Reeves Syringomyelia Research Consortium registry, the authors analyzed variables associated with syrinx radiological outcomes in patients (< 20 years old at the time of surgery) with CM-I+SM undergoing PFD or PFDD. Syrinx resolution was defined as an anteroposterior (AP) diameter of ≤ 2 mm or ≤ 3 mm or a reduction in AP diameter of ≥ 50%. Syrinx regression or progression was defined using 1) change in syrinx AP diameter (≥ 1 mm), or 2) change in syrinx length (craniocaudal, ≥ 1 vertebral level). Syrinx stability was defined as a < 1-mm change in syrinx AP diameter and no change in syrinx length.RESULTSThe authors identified 380 patients with CM-I+SM who underwent PFD or PFDD. Cox proportional hazards modeling revealed younger age at surgery and PFDD as being independently associated with syrinx resolution, defined as a ≤ 2-mm or ≤ 3-mm AP diameter or ≥ 50% reduction in AP diameter. Radiological syrinx resolution was associated with improvement in headache (p < 0.005) and neck pain (p < 0.011) after PFD or PFDD. Next, PFDD (p = 0.005), scoliosis (p = 0.007), and syrinx location across multiple spinal segments (p = 0.001) were associated with syrinx diameter regression, whereas increased preoperative frontal-occipital horn ratio (FOHR; p = 0.007) and syrinx location spanning multiple spinal segments (p = 0.04) were associated with syrinx length regression. Scoliosis (HR 0.38 [95% CI 0.16–0.91], p = 0.03) and smaller syrinx diameter (5.82 ± 3.38 vs 7.86 ± 3.05 mm; HR 0.60 [95% CI 0.34–1.03], p = 0.002) were associated with syrinx diameter stability, whereas shorter preoperative syrinx length (5.75 ± 4.01 vs 9.65 ± 4.31 levels; HR 0.21 [95% CI 0.12–0.38], p = 0.0001) and smaller pB-C2 distance (6.86 ± 1.27 vs 7.18 ± 1.38 mm; HR 1.44 [95% CI 1.02–2.05], p = 0.04) were associated with syrinx length stability. Finally, younger age at surgery (8.19 ± 5.02 vs 10.29 ± 4.25 years; HR 1.89 [95% CI 1.31–3.04], p = 0.01) was associated with syrinx diameter progression, whereas increased postoperative syrinx diameter (6.73 ± 3.64 vs 3.97 ± 3.07 mm; HR 3.10 [95% CI 1.67–5.76], p = 0.003), was associated with syrinx length progression. PFD versus PFDD was not associated with syrinx progression or reoperation rate.CONCLUSIONSThese data suggest that PFDD and age are independently associated with radiological syrinx improvement, although forthcoming results from the PFDD versus PFD randomized controlled trial (NCT02669836, clinicaltrials.gov) will best answer this question.

Currarino syndrome is an autosomal dominant condition with variable expressivity and penetrance that is associated with several classic features: sacral dysgenesis, presacral mass, and/or anorectal anomalies. The authors present a unique case in which the patient’s initial presentation was a CSF leak from a sinus tract. The sinus tract was identified and disconnected from the thecal sac, obliterating the anterior sacral meningocele. This case represents a unique scenario in which Currarino syndrome manifested as a CSF leak from a dermal sinus tract.

Regular physical activity is associated with better physical and mental health outcomes as well as higher quality of life. This pilot randomized controlled trial examined whether approach bias modification, an economical and easily accessible computerized cognitive training, could increase objectively and subjectively measured physical activity in individuals aiming for more physical activity. Forty healthy volunteers of normal weight were randomly allocated to six sessions of approach bias modification or no treatment. The approach bias modification adopted an implicit learning paradigm that trained participants to show approach behavior in response to visual cues of physical activity. Approach bias modification did not increase objectively and subjectively measured physical activity.

Objective Previous research has found increasing evidence for difficulties in emotion recognition ability (ERA) and social cognition in anorexia nervosa (AN), and recent models consider these factors to contribute to the development and maintenance of the disorder. However, there is a lack of experimental studies testing this hypothesis. Therefore, the present proof-of-concept study examined whether ERA can be improved by a single session of a computerized training in AN, and whether this has short-term effects on eating disorder symptoms. Method Forty inpatients (22.20 ± 7.15 years) with AN were randomly assigned to receive a single session of computerized training of ERA (TERA) or a sham training (training the recognition of different types of clouds). ERA, self-reported eating disorder symptoms, and body mass index (BMI) were assessed within 3 days before and after training. Results After training, both groups showed improved ERA, reduced self-reported eating disorder symptoms, and an increased BMI. As compared to patients in the control group, patients who received TERA showed greater improvements in ERA and self-reported eating disorder symptoms. Discussion ERA can be effectively trained in patients with AN. Moreover, short-term improvements in self-reported eating disorder symptoms provide tentative support for the hypothesis that difficulties in ERA contribute to the maintenance of AN, and that specific trainings of ERA hold promise as an additional component in AN treatment. Future studies are needed to replicate these findings in larger samples, and to investigate long-term effects and transfer into real-world settings.

Background Best practice guidelines for verifying fittings of bone-anchored hearing devices (BAHD) recommend using aided sound-field thresholds (ASFT), but express caution regarding the variables impacting obtaining valid and reliable ASFTs.1 Recently, a skull simulator was introduced to facilitate programming BAHD devices in force level (FL) to desired sensation level-bone conduction devices (skull simulator/DSL-BCD)2 3 targets in a hearing aid analyzer. Currently, no evidence is available reporting if differences in measured FL using the manufacturer first-fit (FF) and word recognition in quiet, sentence reception threshold in noise, and subjective outcomes are present for a BAHD programmed using ASFT versus programmed using skull simulator/DSL-BCD targets. Purpose The aim of this study was to examine if significant differences were present in FL using the FF and word recognition in quiet at 50 and 65 decibel of sound pressure level (dB SPL), sentence reception threshold in noise and subjective outcomes using the abbreviated profile of hearing aid benefit (APHAB), and speech, spatial, and qualities of hearing (SSQ) between a BAHD fit using ASFT or skull simulator/DSL-BCD targets. Research Design A double-blind randomized crossover design with 15 adults having unilateral sensorineural hearing loss. All participants were successful users of the Cochlear America Baha 5. Data Collection and Analysis Baha Power 5 devices were fit using FF, ASFT, and skull simulator/DSL-BCD targets. Order of the three fitting strategies was randomly assigned and counter-balanced. Results No significant differences were found for a BAHD device programmed using ASFT versus skull simulator/DSL-BCD targets for consonant-nucleus-consonant words in quiet at 50 or 65 dB SPL, sentence reception threshold in noise, the APHAB or SSQ. There were, however, significant differences, at primarily 500 to 2,000 Hz in measured FLs between the FF, ASFT, and skull simulator/DSL-BCD targets at 50 and 65 dB SPL. Conclusions There were no significant differences in subject performance with two speech measures and subjective responses to two questionnaires for BAHD fittings using ASFT versus using skull simulator/DSL-BCD targets. Differences in FL between the three fitting strategies were present primarily at 500 to 2,000 Hz. Limitations of the study are highlighted along with situations where the skull simulator can play a significantly beneficial role when fitting BAHD devices.

BACKGROUND: Using data from the COHERE collaboration, we investigated whether primary prophylaxis for pneumocystis pneumonia (PcP) might be withheld in all patients on antiretroviral therapy (ART) with suppressed plasma human immunodeficiency virus (HIV) RNA (≤400 copies/mL), irrespective of CD4 count. METHODS: We implemented an established causal inference approach whereby observational data are used to emulate a randomized trial. Patients taking PcP prophylaxis were eligible for the emulated trial if their CD4 count was ≤200 cells/µL in line with existing recommendations. We compared the following 2 strategies for stopping prophylaxis: (1) when CD4 count was >200 cells/µL for >3 months or (2) when the patient was virologically suppressed (2 consecutive HIV RNA ≤400 copies/mL). Patients were artificially censored if they did not comply with these stopping rules. We estimated the risk of primary PcP in patients on ART, using the hazard ratio (HR) to compare the stopping strategies by fitting a pooled logistic model, including inverse probability weights to adjust for the selection bias introduced by the artificial censoring. RESULTS: A total of 4813 patients (10 324 person-years) complied with eligibility conditions for the emulated trial. With primary PcP diagnosis as an endpoint, the adjusted HR (aHR) indicated a slightly lower, but not statistically significant, different risk for the strategy based on viral suppression alone compared with the existing guidelines (aHR, 8; 95% confidence interval, 6-1.1; P = .2). CONCLUSIONS: This study suggests that primary PcP prophylaxis might be safely withheld in confirmed virologically suppressed patients on ART, regardless of their CD4 count., SCOPUS: ar.j, info:eu-repo/semantics/published

Study Design:Systematic literature review.Objectives:To comprehensively review the S2-alar iliac (S2-AI) screw technique for pelvic fixation in pediatric neuromuscular scoliosis.Methods:Articles identified from the PubMed and EMBASE databases were reviewed for relevance and applicability, and the studies were summarized.Results:Eight articles met the inclusion criteria. A total of 277 pediatric patients underwent spinopelvic fixation using S2-AI fixation for neuromuscular scoliosis; the mean follow-up was 3 years (range = 0.75-6 years). Six articles had level III evidence (5 retrospective cohort studies, 1 observational study), and 2 articles had level IV evidence (case series). Wound complications occurred in 34 (12.2%) patients. Instrumentation complications occurred in 36 patients (13.0%), including lucency around the screw (6.5%), screw fracture (3.6%), disengaging of the set/screw or rod from the tulip head (2.8%), and screw displacement (0.7%). Three patients (1.1%) required reoperation for instrumentation failures. The overall reoperation rate—including 3 hardware replacements and 3 cases of L5-S1 pseudarthrosis—was 2.1%. The mean Cobb angle correction was 51.4°, and the mean pelvic obliquity correction was 14.8°; deformity correction was maintained at 3- and 5-year follow-ups. There were 10 (3.6%) cases of implant prominence/implant-related pain, 1 case of sacroiliac joint pain (resolved with longer screw placement), and no major neurological or vascular complications secondary to S2-AI screw placement.Conclusions:This review suggests that the use of S2-AI screws in pediatric neuromuscular scoliosis is efficacious with a reasonable safety profile and provides a useful technique for pelvic fixation in children with scoliosis.

Guidelines recommend adjunct glycoprotein IIb/IIIa inhibitors (GPIs) only in selected patients with acute ST-segment elevation myocardial infarction (STEMI). This study aimed to evaluate routine GPI use in STEMI treated with primary percutaneous coronary intervention.Online databases were searched for randomized controlled trials of routine GPI vs control therapy in STEMI. Data from retrieved studies were abstracted and evaluated in a comprehensive meta-analysis. Twenty-one randomized controlled trials with 8585 patients were included: 10 trials randomized tirofiban, 9 abciximab, 1 trial eptifibatide, and 1 trial used abciximab+tirofiban; only 1 trial used dual antiplatelet therapy with prasugrel/ticagrelor.Routine GPI use was associated with a significant reduction in all-cause mortality at 30 days (2.4% [GPI] vs 3.2%; risk ratio [RR], 0.72; P = 0.01) and 6 months (3.7% vs 4.8%; RR, 0.76; P = 0.02), and a reduction in recurrent myocardial infarction (1.1% vs 2.1%; RR, 0.55; P = 0.0006), repeat revascularization (2.5% vs 4.1%; RR, 0.63; P = 0.0001), thrombolysis in myocardial infarction flow3 after percutaneous coronary intervention (5.4% vs 8.2%; RR, 0.61; P0.0001), and ischemic stroke (RR, 0.42; P = 0.04). Major (4.7% vs 3.4%; RR, 1.35; P = 0.005) and minor bleedings (7.2% vs 5.1%; RR, 1.39; P = 0.006) but not intracranial bleedings (0.1% vs 0%; RR, 2.7; P = 0.37) were significantly increased under routine GPI.Routine GPI administration in STEMI resulted in a reduction in mortality, driven by reductions in recurrent ischemic events-however predominantly in pre-prasugrel/ticagrelor trials. Trials with contemporary STEMI management are needed to confirm these findings.

The complex Chiari, characterized by abnormal craniocervical bony anatomy in addition to Chiari tonsillar herniation, is a relatively recent addition to the concepts surrounding the Chiari literature. The primary findings of complex Chiari include craniocervical kyphosis and retroflexed odontoid, both of which can be described with radiographic measurements. This manuscript will outline the background literature regarding Chiari craniocervical morphometrics and supply an algorithm for the general management of complex Chiari patients.

Background: Patients with chronic kidney disease (CKD) and atrial fibrillation have increased risks for stroke and bleeding under oral anticoagulation (OAC). We investigated an alternative therapy of percutaneous left atrial appendage occlusion (LAAO) in CKD patients in this study.Methods: Consecutive patients undergoing LAAO were included in a retrospective analysis and stratified for kidney function into CKD/Non-CKD groups (cutoff eGFR 60 ml/min). Procedural characteristics, in-hospital and follow-up events were analysed and compared between groups.Results: LAAO was performed in 146 patients (81 CKD; 65 Non-CKD), mean follow-up was 391 days. Groups differed in eGFR (40.1 (CKD) vs. 75.1 (Non-CKD) ml/min) and CHA2DS2VASc scores (4.65 ± 1.3 (CKD) vs. 4.06 ± 1.4 (Non-CKD)). Procedural success was 98.6%, contrast-induced acute kidney injury was significantly more frequent in CKD patients (11.1% vs. 0%; p = .004). Follow-up mortality was higher in CKD (10.5/100 PY vs. 4.2/100 PY; p = .156). Follow-up stroke rates were 2.3/100 (CKD) patient-years (PY) and 1.4/100 PY (Non-CKD) (p = 1.000), corresponding to a relative risk reduction (RRR) of 60% (all), 68% (CKD) and 71% (Non-CKD) compared to expected stroke rates. Follow-up major bleeding rates were 3.5/100 PY (CKD) and 4.2/100 PY (Non-CKD), corresponding to RRR of 57% (all), 61% (CKD) and 53% (Non-CKD) compared to OAC.Conclusions: Left atrial appendage occlusion shows comparable efficacy for stroke and bleeding prevention in CKD and Non-CKD patients. CKD patients experience more adverse events during follow-up and a significantly increased risk for periprocedural contrast-induced acute kidney injury.

The use of intraoperative MRI (iMRI) during treatment of gliomas may increase extent of resection (EOR), decrease need for early reoperation, and increase progression-free and overall survival, but has not been fully validated, particularly in the pediatric population. To assess the accuracy of iMRI to identify residual tumor in pediatric patients with glioma and determine the effect of iMRI on decisions for resection, complication rates, and other outcomes. We retrospectively analyzed a multicenter database of pediatric patients (age ≤ 18 years) who underwent resection of pathologically confirmed gliomas. We identified 314 patients (mean age 9.7 ± 4.6 years) with mean follow-up of 48.3 ± 33.6 months (range 0.03–182.07 months) who underwent surgery with iMRI. There were 201 (64.0%) WHO grade I tumors, 57 (18.2%) grade II, 24 (7.6%) grade III, 9 (2.9%) grade IV, and 23 (7.3%) not classified. Among 280 patients who underwent resection using iMRI, 131 (46.8%) had some residual tumor and underwent additional resection after the first iMRI. Of the 33 tissue specimens sent for pathological analysis after iMRI, 29 (87.9%) showed positive tumor pathology. Gross total resection was identified in 156 patients (55.7%), but this was limited by 69 (24.6%) patients with unknown EOR. Analysis of the largest multicenter database of pediatric gliomas resected using iMRI demonstrated additional tumor resection in a substantial portion of cases. However, determining the impact of iMRI on EOR and outcomes remains challenging because iMRI use varies among providers nationally. Continued refinement of iMRI techniques for use in pediatric patients with glioma may improve outcomes.

Background Bariatric surgery provides sustained weight loss and improves comorbidities. However, long term data has shown that patients gradually regain weight after 1 year. Several factors have been associated with poor weight loss after bariatric surgery. Objective Our goal is to investigate factors associated with poor weight loss following laparoscopic sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB). Setting Military academic medical center. Methods Retrospective review of 247 patients who underwent laparoscopic SG or RYGB between 2010–2012 at Eisenhower Army Medical Center and followed for 5 years postoperatively. Factors of age, type of surgery, sex, hypertension, depression, and type 2 diabetes (T2D) are analyzed in univariate and multivariate analysis with percent total weight loss (%TWL) and Body Mass Index (BMI) change as primary endpoints measured at 3 and 5 years. Results Average BMI change are maximized at 1 year and decreased at 3 and 5 years post-surgery. Age, diabetes, hypertension and type of surgery significantly influenced weight loss at 3 and 5 years on univariate analysis. However, patients with diabetes, hypertension and sleeve gastrectomy were significantly older than comparable control group. Multivariable analysis showed that age and type of surgery, not diabetes or hypertension, were associated with poor %TWL and BMI change at 3 and 5 years. Conclusion While presence of hypertension and diabetes initially appeared to be associated with weight recidivism, their impacts were negligible on multivariable analysis. However, age and sleeve gastrectomy are independent risk factors. Our data can be used to counsel patients on expected weight loss after bariatric surgery.

Food allergies are a growing worldwide concern and the contamination of products with food allergens represents a significant health risk to allergic consumers. With the introduction of reference doses, quantitative methods are needed for the monitoring of allergen levels, and the potential of LC-MS/MS is of hugely growing interest. In this study, we demonstrate that relevant food matrices (bakery products and chocolates) and thermal food processing substantially influence the quantification of 18 marker peptides from various nut and peanut allergens via targeted proteomics. In addition, we characterize the individual release kinetics of marker peptides and provide examples for metastable marker peptide candidates. Matrix recovery rates overall ranged between 15 and 250% with the observed variation being linked to the individual peptide structure as well as to specific matrix interferences. In contrast, thermal processing considerably influences the detectability of allergens on the protein level as different marker peptides from the identical parent allergen are similarly affected, leading to a loss in signal of up to 83% in extreme cases after a 45-min simulated baking. Provided data are finally used for evaluation of different calibrators as well as the overall potential and challenges of LC-MS for the absolute quantification of food allergens. SIGNIFICANCE: With the scientific discussion moving towards a risk-based management of food allergens, including the establishment of threshold doses, robust methods for the absolute quantification of allergens in food samples are urgently needed. Because the currently used antibody- and DNA-based technologies show severe limitations in terms of specificity and reproducibility, LC-MS has emerged as a promising alternative. Its application to absolute quantification, however, first requires an understanding of the various impacts that affect quantification results, including different food matrices, sample preparation, and thermal processing of foodstuffs. Knowledge of these factors, which are assessed as part of a comprehensive survey in this study, is also an important prerequisite to evaluate means of calibration for an LC-MS-based quantification of food allergens.

Oral cancer therapy is associated with a loss in health-related quality of life (HRQOL) and can also lead to post-traumatic growth (PTG). The current study analyzed the relationship between HRQOL, PTG and influencing clinical factors after treatment. The coherent clinical data of 15 patients were retrospectively analyzed over a 1-year study period. HRQOL and PTG were studied using the University of Washington Quality of Life Version 4 (UW-QOL v4) and Posttraumatic Growth Inventory (PTGI) questionnaires. The results revealed that HRQOL was significantly decreased in a pre- to postoperative manner (P=0.011). Sex demonstrated a nearly significant effect on HRQOL (P=0.058). PTG was experienced the most after surgery, and continuously decreased over the 1-year study period. Patient age had a significant effect on PTG (P=0.040). A significant correlation was also established between HRQOL and PTG (P

The purpose of this study was to assess the quality of articles utilizing large administrative databases to answer questions related to pediatric spinal neurosurgery by quantifying their adherence to standard reporting guidelines. A systematic literature search was conducted with search terms including “pediatric” and “neurosurgery,” associated neurosurgical diagnoses, and the names of known databases. Study abstracts were reviewed to identify clinical studies involving pediatric populations, spine-related pathology or procedures, and large administrative databases. Included studies were graded using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) criteria. A total of 28 papers of the initial 1496 identified met inclusion criteria. These papers involved 10 databases and had a mean study period of 11.46 ± 12.27 years. The subjects of these research papers were undergoing treatment of scoliosis (n = 5), spinal cord injury (n = 5), spinal cord tumors (n = 9), and spine surgery in general (n = 9). The mean STROBE score was 19.41 ± 2.02 (out of 22). Large administrative databases are commonly used within pediatric spine-related neurosurgical research to cover a broad spectrum of research questions and study topics. The heterogeneity of research to this point encourages the continued use of large databases to better understand treatment and diagnostic trends, perioperative and long-term outcomes, and rare pathologies within pediatric spinal neurosurgery.

OBJECTIVE This study explored participants' experience of approach bias modification training (ABM) with transcranial Direct Current Stimulation (tDCS) for binge eating disorder (BED) within a randomised controlled trial (RCT). A subset of participants who completed the RCT were interviewed to attain feedback on treatment experience and outcomes. METHOD 15 participants with BED who completed the RCT were recruited, using purposive sampling. Participants received six sessions of concurrent ABM training with either real or sham tDCS. Semi-structured interviews relating to study experience and treatment outcomes were conducted and data were analysed thematically. RESULTS The combined ABM and tDCS intervention was deemed acceptable and worthwhile by participants interviewed across both intervention groups. Negative preconceptions of tDCS were an initial deterrent to study participation for some, yet the brain stimulation experience was found to be tolerable. Minor and transient sensations and side effects attributed to tDCS were reported by most participants during and after stimulation, in addition to less pleasant aspects of ABM training, with no significant adverse effects reported by interviewees. Positive outcomes were described by participants across both intervention groups, relating to changes in BED symptoms and to broader beneficial effects on associated cognitive and emotional factors. Two participants experienced a shift in autonomy, attributed to tDCS and the combined intervention respectively. CONCLUSIONS Adults with symptoms of BED found concurrent ABM and tDCS sessions to be acceptable, despite initial apprehension about the safety of tDCS. Findings are relevant to the neuroethics literature and may inform science communication strategies on neuromodulation treatments.

Objectives: The aim of the study was to determine the time to, and risk factors for, triple-class virological failure (TCVF) across age groups for children and adolescents with perinatally acquired HIV infection and older adolescents and adults with heterosexually acquired HIV infection. Methods: We analysed individual patient data from cohorts in the Collaboration of Observational HIV Epidemiological Research Europe (COHERE). A total of 5972 participants starting antiretroviral therapy (ART) from 1998, aged < 20 years at the start of ART for those with perinatal infection and 15–29 years for those with heterosexual infection, with ART containing at least two nucleoside reverse transcriptase inhibitors (NRTIs) and a nonnucleoside reverse transcriptase inhibitor (NNRTI) or a boosted protease inhibitor (bPI), were followed from ART initiation until the most recent viral load (VL) measurement. Virological failure of a drug was defined as VL > 500 HIV-1 RNA copies/mL despite ≥ 4 months of use. TCVF was defined as cumulative failure of two NRTIs, an NNRTI and a bPI. Results: The median number of weeks between diagnosis and the start of ART was higher in participants with perinatal HIV infection compared with participants with heterosexually acquired HIV infection overall [17 (interquartile range (IQR) 4–111) vs. 8 (IQR 2–38) weeks, respectively], and highest in perinatally infected participants aged 10–14 years [49 (IQR 9–267) weeks]. The cumulative proportion with TCVF 5 years after starting ART was 9.6% [95% confidence interval (CI) 7.0−12.3%] in participants with perinatally acquired infection and 4.7% (95% CI 3.9−5.5%) in participants with heterosexually acquired infection, and highest in perinatally infected participants aged 10–14 years when starting ART (27.7%; 95% CI 13.2−42.1%). Across all participants, significant predictors of TCVF were those with perinatal HIV aged 10–14 years, African origin, pre-ART AIDS, NNRTI-based initial regimens, higher pre-ART viral load and lower pre-ART CD4. Conclusions: The results suggest a beneficial effect of starting ART before adolescence, and starting young people on boosted PIs, to maximize treatment response during this transitional stage of development., 0, SCOPUS: ar.j, FLWOA, info:eu-repo/semantics/published

Objective Very brief exposure to masked images of spider stimuli can facilitate approach behaviour towards spiders in fearful subjects. We hypothesized that a similar effect might occur for fear of food in patients with anorexia nervosa (AN), possibly offering a new treatment approach, with advantages over other methods of food exposure. Methods Patients with AN (n = 60) were randomly assigned to one of three experimental conditions and received a single session of exposure to either masked and very briefly presented food images, clearly visible food images, or masked non-food images (i.e. household items). Effects of the three exposure conditions on fear of food and food avoidance were examined. Results Contrary to our expectations, very brief food cue exposure was not superior to the control conditions regarding fear of food and approach behaviour towards food immediately after the intervention and body mass index four weeks later. Conclusion This finding suggests important differences between fear of food in AN and specific phobias such as fear of spiders. The absence of an effect reveals limitations of the very brief exposure method, which might be better suited for evolutionarily relevant threat stimuli.

The incidence of hepatocellular carcinoma (HCC) in patients co-infected with HIV and hepatitis B virus (HBV) or hepatitis C virus (HCV) is increasing. In patients with cirrhosis, guidelines recommend HCC screening every 6 months. We assessed compliance with HCC screening guidelines in cirrhotic HBV/HCV-HIV-co-infected patients. HBV/HCV-HIV-co-infected patients with cirrhosis were enrolled from 4 European prospective cohorts participating in the COHERE collaboration, followed from 1 January 2005-1 January 2015. Assessment of liver cirrhosis was based on clinical diagnosis and liver biopsy or Fibroscan. Compliance with HCC screening guidelines was defined as one ultrasound every 6 months. Generalized estimating equation models adjusted for repeated measurements were fitted to determine predictors of low compliance. Different sensitivity analyses were performed and validation of the data was carried out by randomly checking 10% of each cohort's data. 646 HIV-patients with the diagnosis of cirrhosis were included: 518 (80%) HCV-, 85 (13%) HBV- and 43 (7%) HBV/HCV-co-infected. Median age at cirrhosis diagnosis was 44 years, median follow-up time since diagnosis was 5.3 years. Screening

Objective: Recent models of anorexia nervosa (AN) emphasise the role of reduced emotion recognition ability (ERA) in the development and maintenance of the disorder. However, methodological limitations impede conclusions from prior research. The current study tries to overcome these limitations by examining ERA with an audio-visual measure that focuses strictly on multimodal nonverbal cues and allows to differentiate between ERA for different emotion categories. Method: Forty women with AN and 40 healthy women completed the Geneva Emotion Recognition Test. This test includes 83 video clips in which 10 actors express 14 different emotions while saying a pseudo-linguistic sentence without semantic meaning. All clips contain multimodal nonverbal cues (i.e., prosody, facial expression, gestures, and posture). Results: Patients with AN showed poorer ERA than the healthy control group (d = 0.71), particularly regarding emotions of negative valence (d = 0.26). Furthermore, a lower body weight (r = 0.41) and longer illness duration (�� = -0.32) were associated with poorer ERA in the AN group. Conclusions: Using an ecologically valid instrument, the findings of the study support illness models emphasising poor ERA in AN. Directly addressing ERA in the treatment of AN with targeted interventions may be promising. Keywords: eating disorder; emotion recognition; social cognition; socio-emotional processing; theory of mind.

Background HIV and hepatitis C virus (HCV) have shared routes of transmission among men who have sex with men (MSM). Routine testing facilitates early diagnosis and treatment, thereby preventing morbidity and onward transmission. We evaluated factors associated with HIV and HCV testing in a behaviorally vulnerable cohort of predominantly MSM. Methods From June 2018 through June 2019, the BRAHMS study enrolled adults at ten German outpatient clinics that serve gender and sexual minority populations. Participants completed behavioral questionnaires that captured prior experience with HIV and HCV testing. Multivariable robust Poisson regression was used to evaluate factors potentially associated with testing in the previous 6 months. Results Among 1017 participants with median age 33 (interquartile range 28–39) years, 1001 (98.4%) reported any lifetime history of HIV testing and 787 (77.4%) reported any HCV testing, including 16 (1.6%) known to be living with HCV. Testing within the last 6 months was reported by 921 (90.6%) and 513 (50.4%) for HIV and HCV, respectively. Recent HIV testing was more common among participants with higher education level and recent HCV testing. Recent HCV testing was more common among participants with non-cisgender identity, lifetime history of illicit drug use, hepatitis B immunity or infection, and recent HIV testing. Conclusion Prior testing for HIV was common in this cohort, but interventions are needed to improve HCV risk stratification and access to testing. HIV testing infrastructure can be successfully leveraged to support HCV testing, but differentiated preventive care delivery is needed for some vulnerable populations.

Summary Chiari I malformation (CM1), the displacement of the cerebellum through the foramen magnum into the spinal canal, is one of the most common pediatric neurological conditions. Individuals with CM1 can present with neurological symptoms, including severe headaches and sensory or motor deficits, often as a consequence of brainstem compression or syringomyelia (SM). We conducted whole-exome sequencing (WES) on 668 CM1 probands and 232 family members and performed gene-burden and de novo enrichment analyses. A significant enrichment of rare and de novo non-synonymous variants in chromodomain (CHD) genes was observed among individuals with CM1 (combined p = 2.4 × 10−10), including 3 de novo loss-of-function variants in CHD8 (LOF enrichment p = 1.9 × 10−10) and a significant burden of rare transmitted variants in CHD3 (p = 1.8 × 10−6). Overall, individuals with CM1 were found to have significantly increased head circumference (p = 2.6 × 10−9), with many harboring CHD rare variants having macrocephaly. Finally, haploinsufficiency for chd8 in zebrafish led to macrocephaly and posterior hindbrain displacement reminiscent of CM1. These results implicate chromodomain genes and excessive brain growth in CM1 pathogenesis.

Background Contrast-induced nephropathy (CIN) is a major adverse event in patients undergoing coronary angiography. The Mehran risk model is the gold-standard for CIN risk prediction. However, its performance in comparison to more contemporary National Cardiovascular Data Registry-Acute Kidney Injury (NCDR-AKI) risk models remains unknown. We aimed to compare both in this study. Methods and results Predictions of Mehran and NCDR-AKI risk models and clinical events of CIN and need for dialysis were assessed in a total of 2067 patients undergoing coronary angiography with or without percutaneous coronary intervention. Risk models were compared regarding discrimination (receiver operating characteristic analysis), net reclassification improvement (NRI) and calibration (graphical and statistical analysis). The NCDR risk model showed superior risk discrimination for predicting CIN (NCDR c-index 0.75, 95% CI 0.72–0.78; vs. Mehran c-index 0.69, 95% CI 0.66–0.72, p NCDRvsMehran Conclusion In German patients undergoing coronary angiography, the modern NCDR risk model for predicting contrast-induced nephropathy showed superior discrimination compared to the Mehran model while showing less accurate calibration. Results for the outcome ‘need for dialysis’ were equivocal. Graphic abstract

Introduction and purpose Patient risk in non-ST-segment elevation myocardial infarction (NSTEMI) depends on clinical setting, individual patient variables and procedural characteristics. Standardized risk-adjusted periprocedural management for catheterization procedures using a Standard Operating Procedure (SOP) was investigated to evaluate associations with in-hospital clinical outcomes. Methods In 01/2018, our heart center established an SOP for coronary catheterization procedures in NSTEMI, targeting 1) standardized pre-procedural risk assessment using National Cardiovascular Data Registry (NCDR) risk models, and 2) standardized post-procedural risk-adjusted safety measures, including advanced patient monitoring (intermediate/intensive care) and use of vascular closure devices. All patients presenting with invasively-managed NSTEMI in 2018 were retrospectively evaluated for SOP-based pre-procedural risk scoring, SOP-based post-procedural management and in-hospital clinical outcomes of mortality, major bleeding (MB, according to BARC ≥3) and acute kidney injury (AKI, according to KDIGO). Results A total of 430 patients (age 72±12 years, 71% male, BMI 27±5) presenting with NSTEMI from 01 to 12/2018 were included, 9.8% presented in cardiogenic shock and 4.7% had suffered a preclinical cardiac arrest. Overall in-hospital mortality was 3.7%, MB occurred in 6.5%. 207 patients (48.1%, SOP+ group) had received both 1) pre-procedural risk assessment and 2) post-procedural risk-adjusted safety measures; the other 223 patients (51.9%, SOP- group) had not received either 1) or 2). There were no significant differences in baseline characteristics and prior-existing medical conditions between groups, however, significantly more patients in SOP- group were treated in emergency settings (39.9% vs. 21.7%, p=0.004). However, significantly more patients in SOP- were treated in emergency settings at higher risk (39.9% (SOP-) vs. 21.7% (SOP+); p Conclusion Standardized risk management in invasively managed NSTEMI was associated with significantly lower rates of in-hospital major bleedings. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Junior Clinician Scientist Track, Medical faculty, Heinrich-Heine-University Düsseldorf, Germany

Background Iron is essential to the mitochondrial energy production in cardiomyocytes and its depletion is negatively associated with symptoms, functional capacity, quality of life and outcomes in patients with heart failure – independent of anemia. The relevance of iron deficiency in adults with congenital heart disease however has not been evaluated to date, and we thus aimed to evaluate it in an all-comer cohort of patients with congenital heart disease in correlation with symptoms and functional capacity. Methods and results 527 patient cases from one referral center over 2 years were evaluated concerning their iron status, anemia, functional capacity and ejection fraction of their systemic ventricle. 264 were female, 94 had a shunt lesion, 96 had left-sided obstructive lesions, 181 right-sided lesions, while 108 were considered to have complex lesions and 28 were cyanotic. The median age was 34 years, the mean BMI was 25.2±5 kg/m2, 429 patients had a normal ejection fraction and 34 moderately and severely depressed. 35 patients were classified as NYHA III, and 56 as NYHA II, while their functional capacity was evaluated via cardiopulmonary testing with a mean VO2max/kg of 22.6±6.5 and mean 69±17% of the expected. The mean serum iron concentration was 99.4±42.3 mcg/dL, their mean transferrin saturation was 27.36±13%, the mean ferritin concentration was 130.8±185 ng/mL, the mean soluble transfer factor was 1.3±0.66 mg/l and their mean Hemoglobin 14.8±2 mg/dL, while the mean MCV was 88±5.3 and the mean MCHC 33.7±1.4. 40 patients were anemic according to the WHO definition for anemia, in 28 of those patients that was already known. Iron deficiency according to stratified according to ferritin was present in 53 patients. However, when stratified according to the heart failure guidelines definition for iron deficiency 299 patients were found affected. Using the soluble transferrin receptor (sTfR) and sTfR-ferritin index iron deficiency was suspected in 10 additional individuals. Iron deficiency was associated with the ejection fraction (p=0.0001) - patients with moderately or severely depressed systemic ventricular function more often were diagnosed with iron deficiency (p=0.007)-, while it did not correlate with functional NYHA classification (p=0.622) or functional capacity (p=0.1 and 0.057). Iron deficiency was also not found significantly different amongst congenital defects but did correlate with all laboratory iron studies. Conclusions In this ambulatory population of adults with congenital heart disease we found an association of ejection fraction with iron deficiency, however no association of iron deficiency with functional capacity. The question arising is if a new definition of iron deficiency anemia in congenital heart disease similar to heart failure would be of clinical value. Funding Acknowledgement Type of funding source: None

Background Uninterrupted anticoagulation during catheter ablation of atrial fibrillation (CAAF) became standard of care after positive results of trials investigating vitamin K antagonists (VKA). Previous studies and meta-analyses of uninterrupted direct oral anticoagulants (DOAC) vs. VKA have given controversial results. We thus aimed to elucidate the risks and benefits of uninterrupted DOAC vs. VKA during CAAF in an updated meta-analysis of randomized controlled trials (RCTs). Methods Online databases were searched for RCTs comparing uninterrupted DOAC to VKA in patients undergoing CAAF until September 2019. Data from retrieved studies were analysed in a comprehensive meta-analysis. Primary safety outcome was major bleeding; primary efficacy outcome was stroke or transient ischemic attack (TIA). Secondary outcomes included a composite of major bleeding and stroke or TIA, minor bleeding, acute cerebral lesions on magnetic resonance imaging (ACL) and mortality. Results Six eligible RCTs comprising 2,369 patients were included. Pooled meta-analysis showed no significant differences in DOAC vs. VKA concerning the rates of major bleeding (2.2% vs. 3.8%; odds ratio (OR) 0.69, 95% confidence interval (CI) 0.30–1.56; p=0.37) and stroke or TIA (0.2% vs. 0.2%; OR 0.97, CI 0.20–4.72; p=0.97). There were no significant differences found in secondary outcomes (OR 0.73, p=0.49 for composite of major bleeding and stroke or TIA; OR 1.08, p=0.52 for minor bleeding; OR 1.12, p=0.59 for ACL; and OR=0.60, p=0.64 for all-cause mortality). Conclusion Our meta-analysis suggests that uninterrupted periprocedural anticoagulation with DOAC or VKA is characterized by a similar risk/benefit ratio in patients undergoing CAAF with comparable rates of major bleeding and stroke. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): Medical faculty of the Heinrich-Heine-University Düsseldorf, Germany

OBJECTIVE Scoliosis is common in patients with Chiari malformation type I (CM-I)–associated syringomyelia. While it is known that treatment with posterior fossa decompression (PFD) may reduce the progression of scoliosis, it is unknown if decompression with duraplasty is superior to extradural decompression. METHODS A large multicenter retrospective and prospective registry of 1257 pediatric patients with CM-I (tonsils ≥ 5 mm below the foramen magnum) and syrinx (≥ 3 mm in axial width) was reviewed for patients with scoliosis who underwent PFD with or without duraplasty. RESULTS In total, 422 patients who underwent PFD had a clinical diagnosis of scoliosis. Of these patients, 346 underwent duraplasty, 51 received extradural decompression alone, and 25 were excluded because no data were available on the type of PFD. The mean clinical follow-up was 2.6 years. Overall, there was no difference in subsequent occurrence of fusion or proportion of patients with curve progression between those with and those without a duraplasty. However, after controlling for age, sex, preoperative curve magnitude, syrinx length, syrinx width, and holocord syrinx, extradural decompression was associated with curve progression > 10°, but not increased occurrence of fusion. Older age at PFD and larger preoperative curve magnitude were independently associated with subsequent occurrence of fusion. Greater syrinx reduction after PFD of either type was associated with decreased occurrence of fusion. CONCLUSIONS In patients with CM-I, syrinx, and scoliosis undergoing PFD, there was no difference in subsequent occurrence of surgical correction of scoliosis between those receiving a duraplasty and those with an extradural decompression. However, after controlling for preoperative factors including age, syrinx characteristics, and curve magnitude, patients treated with duraplasty were less likely to have curve progression than patients treated with extradural decompression. Further study is needed to evaluate the role of duraplasty in curve stabilization after PFD.

Background The area under the concentration-time curve over 24 hours (AUC24 ) is frequently utilized to monitor tobramycin exposure in children with cystic fibrosis (CF). An understanding of exposure target achievement during clinical implementation of an AUC24 based approach in children is limited. Methods A retrospective chart review was performed in children with CF treated with once daily tobramycin and drug concentration monitoring at a pediatric CF center. During clinical care AUC24 was estimated using a traditional log-linear regression approach (LLR). AUC24 was also estimated retrospectively using a pharmacokinetic model-based Bayesian forecasting approach (BF). AUC24 achievement after both approaches were compared. Results In 77 treatment courses (mean age, 12.7 ± 5.0 years), a target AUC24 100 to 125 mg h/L was achieved after starting dose in 21 (27%) and after initial dose adjustment in 35 (45%). In the first 7 days of treatment, 24 (32%) required ≥3 dose adjustments, and the mean number of drug concentrations measured was 7.1 ± 3.2. Examination of a BF approach demonstrated adequate prediction of measured tobramycin concentrations (median bias -2.1% [95% CI -3.1 to -1.4]; median precision 7.6% [95% CI, 7.1%-8.2%]). AUC24 estimates utilizing the BF approach were higher than the LLR approach with a mean difference of 6.4 mg h/L (95% CI, 4.8 to 8.0 mg h/L). Conclusions Achievement of a narrow AUC24 target is challenging during clinical care, and dose individualization is needed in most children with CF. Implementing a BF approach for estimating AUC24 in children with CF is supported.

Objective Patients with anorexia nervosa (AN) often show difficulties in the perception, expression, and regulation of emotions and a strong avoidance of aversive feelings. According to psychobiological models, dietary restraint and accompanying weight loss may serve as a maladaptive mechanism of emotion regulation by attenuating aversive emotional states in AN, thereby contributing to the maintenance of the disorder. Method Twenty-seven women with AN and 26 age-matched healthy women were shown short film-clips to elicit fear, sadness, amusement, and neutral emotional states. Eyeblink startle response was measured by electromyography in reaction to startle-eliciting acoustic stimuli presented 12 times binaurally during each film-clip. Results As compared to healthy controls, patients with AN showed a blunted startle response to the fear- but not to the sadness-eliciting stimulus. Discussion The findings support the assumption that underweight is associated with attenuated emotional reactivity to fear-eliciting material in AN. This is in line with the hypothesis that starvation and low body weight constitute a maladaptive mechanism of emotion regulation in AN, contributing to the maintenance of the disorder.

Dropping out of psychotherapeutic treatment (i.e., the patient ending treatment unilaterally) poses a problem for patients, therapists, and the health care sector. Previous research showed that changes in symptom severity and general change mechanisms (GCMs), such as interpersonal experiences, intrapersonal experiences, and problem actuation, might be related to drop-out. We investigated the relationship of these predictors and drop-out in a sample of 724 patients (21.1% drop-out) receiving cognitive-behavioral therapy in routine care from a German outpatient clinic. Survival analysis was used to account for the longitudinal nature of the data created by routine outcome monitoring and to deal with the time varying predictors, GCMs, and changes in symptom severity. As outcome, we predicted the risk of dropping out. Results showed that patient- and therapist-rated interpersonal experiences, which include alliance, significantly predicted the risk for drop-out. Contrary to previous research, intrapersonal experiences and symptom severity change did not predict drop-out. Overall, GCMs and symptom severity change accounted for 3.8% of explained variance in the outcome. These results entail that it is important to monitor interpersonal experiences over the course of treatment to identify patients at risk for drop-out. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

OBJECTIVEThe authors’ objective was to better understand the anatomical load-bearing relationship between the atlantooccipital joint and the upper cervical spine and its influence on the clinical behavior of patients with Chiari malformation type I (CM-I) and craniocervical pathology.METHODSIn a single-center prospective study of patients younger than 18 years with CM-I from 2015 through 2017 (mean age 9.91 years), the authors measured the occipital condyle–C2 sagittal vertebral alignment (C–C2SVA; defined as the position of a plumb line from the midpoint of the occiput (C0)–C1 joint relative to the posterior aspect of the C2–3 disc space), the pB–C2 (a line perpendicular to a line from the basion to the posteroinferior aspect of the C2 body on sagittal MRI), and the CXA (clivoaxial angle). Control data from 30 patients without CM-I (mean age 8.97 years) were used for comparison. The primary outcome was the need for anterior odontoid resection and/or occipitocervical fusion with or without odontoid reduction. The secondary outcome was the need for two or more Chiari-related operations.RESULTSOf the 60 consecutive patients with CM-I identified, 7 underwent anterior odontoid resection or occipitocervical fusion and 10 underwent ≥ 2 decompressive procedures. The mean C–C2SVA was greater in the overall CM-I group versus controls (3.68 vs 0.13 mm, p < 0.0001), as was the pB–C2 (7.7 vs 6.4 mm, p = 0.0092); the CXA was smaller (136° vs 148°, p < 0.0001). A C–C2SVA ≥ 5 mm was found in 35% of CM-I children and 3.3% of controls (p = 0.0006). The sensitivities and specificities for requiring ventral decompression/occipitocervical fusion were 100% and 74%, respectively, for C–C2SVA ≥ 5 mm; 71% and 94%, respectively, for CXA < 125°; and 71% and 75%, respectively, for pB–C2 ≥ 9 mm. The sensitivities and specificities for the need for ≥ 2 decompressive procedures were 60% and 70%, respectively, for C–C2SVA ≥ 5 mm; 50% and 94%, respectively, for CXA < 125°; and 60% and 76%, respectively, for pB–C2 ≥ 9 mm. The log-rank test demonstrated significant differences between C–C2SVA groups (p = 0.0007) for the primary outcome. A kappa value of 0.73 for C–C2SVA between raters indicated substantial agreement.CONCLUSIONSA novel screening measurement for craniocervical bony relationships, the C–C2SVA, is described. A significant difference in C–C2SVA between CM-I patients and controls was found. A C–C2SVA ≥ 5 mm is highly predictive of the need for occipitocervical fusion/ventral decompression in patients with CM-I. Further validation of this screening measurement is needed.

Background To date, no studies have successfully shown that a highly specific, blood-based tumour marker to detect clinically relevant HPV-induced disease could be used for screening, monitoring therapy response or early detection of recurrence. This study aims to assess the clinical performance of a newly developed HPV16-L1 DRH1 epitope-specific serological assay. Methods In a multi-centre study sera of 1486 patients (301 Head and Neck Squamous Cell Carcinoma (HNSCC) patients, 12 HIV+ anal cancer patients, 80 HIV-positive patients, 29 Gardasil-9-vaccinees, 1064 healthy controls) were tested for human HPV16-L1 DRH1 antibodies. Analytical specificity was determined using WHO reference-sera for HPV16/18 and 29 pre- and post-immune sera of Gardasil-9-vaccinees. Tumour-tissue was immunochemically stained for HPV-L1-capsidprotein-expression. Findings The DRH1-competitive-serological-assay showed a sensitivity of 95% (95% CI, 77.2–99.9%) for HPV16-driven HNSCC, and 90% (95% CI, 55.5–99.7%) for HPV16-induced anal cancer in HIV-positives. Overall diagnostic specificity was 99.46% for men and 99.29% for women ≥ 30 years. After vaccination, antibody level increased from average 364 ng/ml to 37,500 ng/ml. During post-therapy-monitoring, HNSCC patients showing an antibody decrease in the range of 30–100% lived disease free over a period of up to 26 months. The increase of antibodies from 2750 to 12,000 ng/ml mirrored recurrent disease. We can also show that the L1-capsidprotein is expressed in HPV16-DNA positive tumour-tissue. Interpretation HPV16-L1 DRH1 epitope-specific antibodies are linked to HPV16-induced malignant disease. As post-treatment biomarker, the assay allows independent post-therapy monitoring as well as early diagnosis of tumour recurrence. An AUC of 0.96 indicates high sensitivity and specificity for early detection of HPV16-induced disease. Funding The manufacturer provided assays free of charge.

Allergic reactions to food are among the major food safety concerns in industrialized countries, and it is estimated that approximately 5% of the population suffers from immunoglobulin-E-mediated food allergy. High-resolution mass spectrometry has become one of the most important techniques for the molecular characterization of allergens, including structural modification, degradation in the gastrointestinal environment, or identification of suitable marker peptides for the development of novel analytical approaches, in the past decade. This perspective aims to briefly summarize the current situation and discuss future developments.

Background Aspirin is a key element in prevention of cardiovascular and thromboembolic events. During non-cardiac surgery however, its balance of bleeding risks and benefits remains unclear. Methods A systematic review and meta-analysis of randomized controlled trials was performed. Online databases were screened for clinical trials randomizing aspirin to no aspirin therapy in non-cardiac surgery. Clinical outcomes of all-cause mortality and cardiovascular mortality, arterial ischemic events, venous thromboembolic events and bleeding events were separately evaluated. Results Seven RCTs comprising 28,302 patients were included. All-cause mortality (3.7% vs. 3.8%; odds ratio (OR) 0.97, CI 0.86–1.10) and cardiovascular mortality (2.0% vs. 2.1%, OR 0.92; CI 0.78–1.09) were not different in aspirin vs. no aspirin groups. Arterial ischemic events showed no differences, including myocardial infarction (2.5% (aspirin) vs. 2.5% (no aspirin)), cerebrovascular events (0.6% (aspirin) vs. 0.6% (no aspirin)) and peripheral arterial events (0.2% (aspirin) vs. 0.3% (no aspirin)). Aspirin significantly reduced the risk for venous thromboembolic events (VTE; 1.5% (aspirin) vs. 2.0% (no aspirin); OR 0.74, CI 0.59–0.94, p =0.02). Perioperative major bleeding was significantly more frequent in aspirin groups (4.4% vs. 3.7%; OR 1.18, CI 1.05 to 1.33, p =0.007). Conclusion Aspirin remained neutral with respect to overall survival, cardiovascular mortality and arterial ischemic events. It reduced venous thromboembolic events at the expense of perioperative major bleedings. Thus, this analysis supports recommendations against perioperative aspirin continuation/initiation in cardiovascular disease patients at intermediate risk, as well as recommendations of aspirin for VTE prophylaxis in orthopedic patients only.

A distorted body image and pronounced body dissatisfaction are hallmarks of anorexia nervosa (AN) that typically result in dietary restraint and compensatory behaviours. Cognitive biases such as negative interpretation bias are considered key maintaining factors of these maladaptive cognitions and behaviours. However, little attention has been paid to empirical tests whether negative interpretation bias exists in AN and to what degree it is associated with symptom severity. Participants in the present study were 40 women with AN and 40 healthy women with no history of an eating disorder. Body-related negative interpretation bias (i.e., a tendency to interpret ambiguous information about the own body in a negative way) was measured by a Scrambled Sentences Task. Patients with AN showed a stronger body-related negative interpretation bias than healthy controls. Within both groups, negative interpretation bias correlated strongly and positively with AN symptom severity and these effects were not moderated by levels of depressive symptoms. The findings support the idea that biased interpretation of body-related information is associated with the specific psychopathology of AN. Targeted, computerised interventions (e.g. interpretation bias modification) may help to alter these dysfunctional cognitive schemas that lie at the heart of AN.

This guideline updates the 2010 European guideline for the management of hepatitis B and C virus infections. It is primarily intended to provide advice on testing, prevention and initial management of viral hepatitis B and C for clinicians working in sexual health clinical settings in European countries. The guideline is in a new question and answer format based on clinical situations, from which population/intervention/comparison/outcome questions were formulated. Updates cover areas such as epidemiology, point-of-care tests for hepatitis B, hepatitis C risk and ‘chemsex’, and HIV pre-exposure prophylaxis and hepatitis B. We have also included a short paragraph on hepatitis E noting there is no evidence for sexual transmission. The guideline has been prepared in accordance with the Europe protocol for production available at http://www.iusti.org/regions/europe/pdf/2017/ProtocolForProduction2017.pdf

Allergy to sesame seeds is a food allergy of high relevance due to its high abundance and the potential to elicit allergenic reactions, possibly resulting in anaphylaxis. The major sesame allergen Ses i 1 is a 2S albumin belonging to the family of seed storage proteins and despite its high allergenicity, comprehensive knowledge about Ses i 1 variants is still lacking. We, therefore, performed a detailed sequence analysis and characterized the C- and N-terminal ragged clipping of the small and large subunit of Ses i 1 using high-resolution mass spectrometry and the combination of bottom–up, middle–down, and top–down proteomic approaches. We detected extensive clipping at the C-terminus of the large (3–9 aa) and the small subunit (0–7 aa). In addition, the N-terminal conversion from glutamine to pyroglutamate and limited N-terminal clipping was confirmed for both subunits. Furthermore, we observed a sequence conflict at position 147 of Ses i 1 as well as a sequence shift of the large subunit compared to the reference sequence of the precursor.

Background Heightened sensitivity towards reward and insensitivity towards disadvantageous consequences may constitute a driving factor underlying unrestricted food intake and consequent weight gain in people with overweight and obesity. Therefore, the present study applied a behavioral economics approach to investigate the potential contribution of poor reward-related decision making to unsuccessful long-term weight loss maintenance (i.e. weight cycling). Based on previous research, it was expected that successful long-term weight loss maintainers would show a better performance in a gambling task than their less successful counterparts. Methods Reward-related decision making was assessed post hoc using the Game of Dice Task in a total of 33 overweight and obese women who had either (a) successfully maintained initial weight loss of at least 10% of their body weight over one year or (b) had regained weight until at least their initial body weight prior to weight reduction (i.e. showed weight cycling). Results The groups did not differ in terms of age, current body weight, magnitude of initial weight reduction, educational level, and global intelligence level. As hypothesized, however, the group of successful long-term weight loss maintainers performed significantly better (i.e. showed less impulsive, more advantageous choices) in the Game of Dice Task than their less successful counterparts. Conclusions The findings suggest that poor reward-related decision making is associated with weight cycling which is considered a key concern in weight loss treatments for overweight and obesity. Furthermore, the findings speak in favor of specific psychological interventions that are designed to bolster reward-related decision making.

The bilateral sagittal split mandibular osteotomy (BSSMO), a common maxillofacial technique for expanding the oropharynx during treatment of micrognathia, is a rarely employed but useful adjunct to improve surgical access to the ventral cervical spine in children. Specifically, it provides enhanced exposure of the craniocervical junction in the context of midface hypoplasia, and of the subaxial cervical spine in children with severe kyphosis. The authors describe their technique for BSSMO and evaluate long-term outcomes in patients. The pediatric neurosurgical database at a single center was queried to identify children who underwent BSSMO as an adjunct to cervical spine surgery over a 22-year study period (1993–2015). The authors retrospectively reviewed clinical and radiographic data in all patients. The authors identified 5 children (mean age 5.3 ± 3.1 years, range 2.1–10.0 years) who underwent BSSMO during cervical spine surgery. The mean clinical follow-up was 3.0 ± 1.9 years. In 4 children, BSSMO was used to increase the size of the oropharynx and facilitate transoral resection of the odontoid and anterior decompression of the craniocervical junction. In 1 patient with subaxial kyphosis and chin-on-chest deformity, BSSMO was used to elevate the chin, improve anterior exposure of the subaxial cervical spine, and facilitate cervical corpectomy. Careful attention to neurovascular structures, including the inferior alveolar nerve, lingual nerve, and mental branch of the inferior alveolar artery, as well as minimizing tongue manipulation and compression, are critical to complication avoidance. The BSSMO is a rarely used but extremely versatile technique that significantly enhances anterior exposure of the craniocervical junction and subaxial cervical spine in children in whom adequate visualization of critical structures is not otherwise possible.

Sudden cardiac death (SCD) is frequent in patients with heart failure due to dilated cardiomyopathy (DCM). Implantable cardioverter/defibrillator (ICD) device therapy is currently used for primary prevention. However, publication of the DANISH trial has recently given reason for doubt, showing no significant improvement in all-cause mortality in comparison to contemporary medical therapy. We performed a meta-analysis of all randomized controlled trials comparing ICD therapy to medical therapy (MT) for primary prevention in DCM. The primary outcome was all-cause mortality; secondary analyses were performed on sudden cardiac death, cardiovascular death and non-cardiac death. Five trials including a total of 2992 patients were included in the pooled analysis. Compared to contemporary medical treatment there was a significant mortality reduction with ICD device therapy [odds ratio (OR) 0.77, 95% confidence interval (CI) 0.64–0.93; p = 0.006]. SCD was decreased significantly (OR 0.43, CI 0.27–0.69; p = 0.0004), while cardiovascular death and non-cardiac death showed no differences. Sensitivity analyses showed no influence of amiodarone therapy on overall results. Analysis of MT details revealed the DANISH population to adhere the most to current guideline recommendations. In addition, it was the only study including a substantial amount of CRT devices (58%). Our meta-analysis of all available randomized evidence shows a survival benefit of ICD therapy for primary prevention in DCM. DANISH results suggest an attenuation of this ICD advantage when compared to contemporary medical and cardiac resynchronization therapy. Until larger trials have confirmed this finding, ICD therapy should remain the recommendation for primary prevention of SCD in DCM.