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We present a dataset of six metagenomes and 323 metagenome assembled genomes (MAGs) describing the microbial community of anaerobic digesters at three Canadian pulp and paper mills. Our objective was to assess the coding potential of the microbial community and obtain draft genomes of key organisms in the digesters.

The long-term health effects of football (soccer) have received significant attention in recent years. While brain health is currently the focus of this interest, potential long-term risks or benefits related to cardiovascular and metabolic diseases and cancer are also of interest to sports medicine professionals. However, studies assessing the overall health risks for professional football players remain scarce. We introduce 'SoccHealth', a satellite project to the German National Cohort (NAKO), Germany's largest population-based cohort study. SoccHealth examined 348 former professional football players aged 40-69 using the infrastructure and comprehensive examination programme of NAKO. The German Statutory Accidental Insurance for Professional Athletes identified and invited male players, while female players were recruited among former national team members. Details of the examination programme and the sociodemographic and career-related characteristics of the participants are described. The identical examination programme for the NAKO participants provides the opportunity to draw general population controls according to various definitions and focus on the respective research question to be analysed. This report delineates one approach to evaluate the long-term health effects of football across a broad range of diseases., Competing Interests: Senior author TM is chairman of the DFB's and the European Football Confederation's (UEFA's) medical committee as well as DFL's working group 'Medicine in Professional Football'. All other authors have nothing to declare., (Copyright © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: Portable near-infrared spectroscopy devices allow measurements of muscle oxygen saturation (SmO 2 ) in real time and non-invasively. To use NIRS for typical applications including intensity control and load monitoring, the day-to-day variability needs to be known to interpret changes confidently. This study investigates the absolute and relative test-retest reliability of the Moxy Monitor and investigates side differences of SmO 2 at the vastus lateralis muscle of both legs in cyclists., Methods: Twelve trained cyclists and triathletes completed 3 incremental step tests with 5 min step duration starting at 1.0 W/kg with an increase of 0.5 W/kg separated by 2-7 days. SmO 2 was averaged over the last minute of each stage. For all power outputs, the intra-class coefficient (ICC), the standard error of measurement (SEM) and the minimal detectable change (MDC) were calculated. Dominant and non-dominant leg SmO 2 were compared using a three-factor ANOVA and limits of agreement (LoA)., Results: ANOVA showed no significant systematic differences between trials and side. For both legs and all intensities, the ICC ranged from 0.79 to 0.92, the SEM from 5 to 9% SmO 2 and the MDC from 14 to 18% SmO 2 . The bias and LoA between both legs were -2.0% ± 19.9% SmO 2 ., Conclusion: Relative reliability of SmO 2 was numerically good to excellent according to current standards. However, it depends on the specific analytical goal whether the test-retest reliability is deemed sufficient. Wide LoA indicate side differences in muscle oxygenation during exercise unexplained by leg dominance., (© 2024. The Author(s).)

Pathogenic variants in the Cu/Zn superoxide dismutase (SOD1) gene can be detected in approximately 2% of sporadic and 11% of familial amyotrophic lateral sclerosis (ALS) patients in Europe. We analyzed the clinical phenotypes of 83 SOD1-ALS patients focusing on patients carrying the most frequent (likely) pathogenic variants (R116G, D91A, L145F) in Germany. Moreover, we describe the effect of tofersen treatment on ten patients carrying these variants. R116G patients showed the most aggressive course of disease with a median survival of 22.0 months compared to 198.0 months in D91A and 87.0 months in L145F patients (HR 7.71, 95% CI 2.89-20.58 vs. D91A; p < 0.001 and HR 4.25, 95% CI 1.55-11.67 vs. L145F; p = 0.02). Moreover, R116G patients had the fastest median ALSFRS-R progression rate with 0.12 (IQR 0.07-0.20) points lost per month. Median diagnostic delay was 10.0 months (IQR 5.5-11.5) and therefore shorter compared to 57.5 months (IQR 14.0-83.0) in D91A (p < 0.001) and 21.5 months (IQR 5.8-38.8) in L145F (p = 0.21) carriers. As opposed to D91A carriers (50.0%), 96.2% of R116G (p < 0.001) and 100.0% of L145F (p = 0.04) patients reported a positive family history. During tofersen treatment, all patients showed a reduction of neurofilament light chain (NfL) serum levels, independent of the SOD1 variant. Patients with SOD1-ALS carrying R116G, D91A, or L145F variants show commonalities, but also differences in their clinical phenotype, including a faster progression rate with shorter survival in R116G, and a comparatively benign disease course in D91A carriers., (© 2024. The Author(s).)

The human microbiome emerges as a promising reservoir for diagnostic markers and therapeutics. Since host-associated microbiomes at various body sites differ and diseases do not occur in isolation, a comprehensive analysis strategy highlighting the full potential of microbiomes should include diverse specimen types and various diseases. To ensure robust data quality and comparability across specimen types and diseases, we employ standardized protocols to generate sequencing data from 1931 prospectively collected specimens, including from saliva, plaque, skin, throat, eye, and stool, with an average sequencing depth of 5.3 gigabases. Collected from 515 patients, these samples yield an average of 3.7 metagenomes per patient. Our results suggest significant microbial variations across diseases and specimen types, including unexpected anatomical sites. We identify 583 unexplored species-level genome bins (SGBs) of which 189 are significantly disease-associated. Of note, the existence of microbial resistance genes in one specimen was indicative of the same resistance genes in other specimens of the same patient. Annotated and previously undescribed SGBs collectively harbor 28,315 potential biosynthetic gene clusters (BGCs), with 1050 significant correlations to diseases. Our combinatorial approach identifies distinct SGBs and BGCs, emphasizing the value of pan-body pan-disease microbiomics as a source for diagnostic and therapeutic strategies., (© 2024. The Author(s).)

Purpose: Adequate physical fitness is a key requirement for elite footballers. Maximal fitness tests are the standard for evaluating fitness but are often fatiguing and time consuming. This study investigated the ability of various minimally invasive protocols to reflect changes in standard parameters of football players' physical fitness., Methods: Twenty-one elite junior footballers performed 2 standard fitness tests (stepwise incremental treadmill test with blood-lactate and heart-rate [HR] measurements and Yo-Yo Intermittent Recovery 1 test) and various proxy fitness evaluations (submaximal runs with measurement of exercise HR and HR recovery and external-to-internal load ratios with data collected during match play) 3 times over the course of 19 weeks. Changes in the standard parameters were compared with changes in proxy parameters., Results: Changes in maximal endurance performance showed small to moderate associations with HR-based proxy parameters (r = -.1 to -.46; P = .004-.56), whereas changes in the running velocity at anaerobic threshold had trivial to moderate associations (r = -.07 to -.39; P = .01-.67). Alterations in HR recovery following 2 short, submaximal runs were very largely correlated with changes in the running velocity corresponding to an HR of 170 beats·min-1 (r = -.74 and r = -.75; P < .001). Changes in external-to-internal load ratios derived from match play were not significantly correlated with changes in any of the standard parameters (r = -.03 to .31; P > .05)., Conclusions: Parameters of maximal running performance and parameters describing physiological thresholds do not seem to be adequately captured by different minimally invasive protocols. In contrast, HR recovery following short, submaximal runs may be a valid tool to monitor changes in aerobic endurance adaptations.

Objective: To explore the perspectives of young adult males with spina bifida (SB) on their fertility potential and parenthood., Methods: Semi-structured qualitative interviews were conducted between 2/2021 and 5/2021 with men ≥18 years of age with SB on perspectives on fertility potential and parenthood. Demographic and clinical characteristics were obtained from a survey and chart review. Interviews were transcribed verbatim and assessed through conventional content analysis framework., Results: Of 30 eligible individuals approached, 20 agreed to participate. Median age was 22.5 years (range 18-29), and 80% had myelomeningocele. Most reported not being in a relationship (14/20, 70%), not being currently sexually active (13/20, 65%), and no participant reported a history of paternity. Many reported a desire for future fertility. Uncertainty and areas of concern were identified regarding their physiologic and psychosocial ability to be a parent. Perceived barriers to achieving parenthood included (1) uncertainty around fertility potential and the hereditary nature of SB; and (2) concerns with being a parent and raising a child. Facilitators to help overcome uncertainty, such as gaining knowledge on fertility testing options and understanding means of preventing neural tube defects, were identified. Participants expressed the importance of strong peer and family support to help overcome challenges related to parenthood., Conclusion: Men with SB are interested in future fertility, yet uncertainty exists around the physiologic and psychosocial ability to be a parent. Facilitators to help overcome uncertainty and concerns should be a focus of patient counseling around future fertility with young men with SB., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Elastography is an emerging diagnostic technique that uses conventional imaging modalities such as sonography or magnetic resonance imaging to quantify tissue stiffness. However, different elastography methods provide different stiffness values, which require calibration using well-characterized phantoms or tissue samples. A comprehensive, fast, and cost-effective elastography technique for phantoms or tissue samples is still lacking. Therefore, we propose ultrasound Bessel-fit-based time harmonic elastography (B-THE) as a novel tool to provide rapid feedback on stiffness-related shear wave speed (SWS) and viscosity-related wave penetration rate (PR) over a wide range of harmonic vibration frequencies. The method relies on external induction and B-mode capture of cylindrical shear waves that satisfy the Bessel wave equation for efficient fit-based parameter recovery. B-THE was demonstrated in polyacrylamide phantoms in the frequency range of 20-200 Hz and was cross-validated by magnetic resonance elastography (MRE) using clinical 3-T MRI and compact 0.5-T tabletop MRI scanners. Frequency-independent material parameters were derived from rheological models and validated by numerical simulations. B-THE quantified frequency-resolved SWS and PR 13 to 176 times faster than more expensive clinical MRE and tabletop MRE and have a good accuracy (relative deviation to reference: 6 %, 10 % and 4 % respectively). Simulations of liver-mimicking material phantoms showed that a simultaneous fit of SWS and PR based on the fractional Maxwell rheological model outperformed a fit on PR solely. B-THE provides a comprehensive and fast elastography technique for the quantitative characterization of the viscoelastic behavior of soft tissue mimicking materials., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests. Ingolf Sack reports financial support was provided by German Research Foundation. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objective: This study aimed to identify potential changes in cardiorespiratory fitness among athletes who had previously been infected with SARS-CoV-2., Methods: In this prospective observational multicenter hybrid study (CoSmo-S), cardiopulmonary exercise testing on treadmills or bicycle ergometers involving 2314 athletes (39.6% female) was conducted. German federal squad members (59.6%) and non-squad athletes were included in the study. 1170 (37.2% female) subjects were tested positive for SARS-CoV-2 via PCR from which we had pre-SARS-CoV-2 infection examinations available for 289 subjects. Mixed effect models were employed to analyze amongst others the following dependent variables: Power output at individual anaerobic threshold (POIAT/kg), maximal power output (POmax/kg), measured V̇O2max/kg, heart rate at individual anaerobic threshold (HRIAT) and maximal heart rate (HRmax)., Results: A SARS-CoV-2 infection was associated with a decrease in POIAT/kg (-0.123 W/kg, p < 0.001), POmax/kg (-0.099 W/kg, p = 0.002), measured V̇O2max/kg (-1.70 ml/min/kg, p = 0.050) and an increase HRIAT (2.50 b/min, p = 0.008), HRmax (2.59 b/min, p < 0.001) within the first 60 days after SARS-CoV-2 infection. Using the pandemic onset in Germany as longitudinal reference point, the healthy control group showed no change over time in these variables respectively an increase in POmax (+0.126 W/kg, p = 0.039) during the first 60 days after the reference point. Subgroup analyses showed that both squad members and endurance athletes experienced greater decreases in cardiorespiratory fitness compared to non-squad members respectively athletes from explosive power sports., Conclusions: A SARS-CoV-2 infection is associated with a decline in cardiorespiratory fitness in athletes for approximately 60 days. Potential factors contributing to this outcome seem to be cardio-pulmonary and vascular alterations in consequence of SARS-CoV-2. A minor effect on cardiorespiratory fitness has training interruption due to acute symptoms and/or quarantine., Competing Interests: Conflict of Interest and Funding Source: This work is supported by the Bundesinstitut für Sportwissenschaft (BISp), FKZ 2521BI0106. KR is the owner of the software company "Ergonizer Software e.K., Germany". CR received grants from the Heinz Nixdorf Westfalian Foundation and honoraria from the German Football Association (DFB) and Union of European Football Association (UEFA) in the past 3 years., (Copyright © 2024 by the American College of Sports Medicine.)

Background: Injury risk in professional football (soccer) is increased in the weeks following return-to-play (RTP). However, the time course of injury risk after RTP (the hazard curve) as well as its influencing factors are largely unknown. This knowledge gap, which is arguably due to the volatility of instantaneous risk when calculated for short time intervals, impedes on informed RTP decision making and post-RTP player management., Objectives: This study aimed to characterize the hazard curve for non-contact time-loss injuries after RTP in male professional football and to investigate the influence of the severity of the index injury and playing position., Methods: Media-based injury records from the first German football league were collected over four seasons as previously published. Time-to-event analysis was employed for non-contact time-loss injury after RTP. The Kaplan-Meier survival function was used to calculate the cumulative hazard function, from which the continuous hazard function was retrieved by derivation., Results: There were 1623 observed and 1520 censored events from 646 players analyzed. The overall shape of the hazard curve was compatible with an exponential decline of injury risk, from an approximately two-fold level shortly after RTP towards baseline, with a half-time of about 4 weeks. Interestingly, the peak of the hazard curve was slightly delayed for moderate and more clearly for severe index injuries., Conclusions: The time course of injury risk after RTP (the hazard curve) can be characterized based on the Kaplan-Meier model. The shape of the hazard curve and its influencing factors are of practical as well as methodological relevance and warrant further investigation., (© 2024. The Author(s).)

Objective : To report the frequency of pathogenic SOD1 gene variants in a screening program in amyotrophic lateral sclerosis (ALS), and the clinical practice of transition to an expanded access program (EAP) of tofersen treatment. Methods : From October 2021 to February 2024, at 11 ALS centers in Germany genetic testing for SOD1 , FUS , TARDBP, and C9orf72 was performed. Patients were offered to opt for notification either about all genetic variants or SOD1 variants relevant for tofersen therapy. The transition to the EAP with tofersen was assessed. Results : 1935 patients were screened (94.7% sporadic ALS). 48.8% ( n  = 928) opted for notification of treatment-relevant information. Genetic variants were found as follows: SOD1 (likely) pathogenic variants (class 4/5) 1.8% ( n  = 34), variants of unknown significance (class 3) 0.8% ( n  = 16), FUS (class 4/5) 0.9% ( n  = 17) , TARDBP (class 4/5) 1.3% ( n  = 25), C9orf72 hexanucleotide repeat expansion 7.0% ( n  = 135). In SOD1 -ALS (encompassing class 3-5 variants, n  = 50), 68.0% ( n  = 34) reported a negative family history. 74.0% ( n  = 37) of SOD1 -ALS patients - which represent 1.9% of all participants of the screening program - were transitioned to tofersen. Median duration from start of genetic testing to treatment was 94 days (57 to 295 days). Eight patients declined treatment whereas five individuals died before initiation of therapy. Conclusion : The finding of SOD1 variants in patients with a negative family history underscores the need for a broad genetic screening in ALS. In SOD1 -ALS, the treatment option with tofersen was mostly utilized. The wide range in the transition time to tofersen calls for a SOD1 -ALS management program.

Objective: Systemic immune, inflammatory, and nutritional indices are prognostic across multiple tumor sites. Comprehensive analysis of these markers in patients with locally advanced cervical cancer (LACC) treated with definitive (chemo)radiotherapy [(C)RT] is limited and may assist with future prognostication., Methods: For this retrospective cohort study, patients with LACC treated with definitive (C)RT were identified from a comprehensive cancer center's clinicopathological database. Pre-treatment indices were derived including systemic immune-inflammation index (SII), platelet lymphocyte ratio (PLR), neutrophil lymphocyte ratio (NLR), monocyte lymphocyte ratio (MLR), albumin to alkaline phosphatase ratio (AAPR) and prognostic nutritional index (PNI). Univariate analysis was performed for PFS and OS. ROC curves were analyzed to determine optimal cut points. PFS and OS were assessed by the Kaplan-Meier method and Log-Rank test. Multivariate analysis was performed using Cox regression., Results: 196 patients were identified: median follow-up 7 years (IQR 2-11). Higher SII (≤700 vs >700; p = 0.01), higher PLR (≤ 250 vs >250; p < 0.001) and higher NLR (≤ 5 vs >5; p = 0.003) were associated with worse PFS. Higher SII (≤700 vs >700: p = 0.02), higher PLR (≤ 250 vs >250: p < 0.001) and higher NLR (≤ 5 vs >5; p = 0.01) were associated with worse OS. On multivariate analysis, SII, NLR and PLR were independently associated with PFS. SII and PLR were independently associated with OS., Conclusions: SII and PLR were independently associated with PFS and OS in patients with LACC treated with definitive (C)RT. NLR was independently associated with PFS. High inflammatory state is associated with shorter survival suggesting this as a target for interventions if validated in future studies., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: MK is a consultant for Helix Biopharma (outside the scope of this study). MK is an Editorial Board Member for Gynecologic Oncology and was not involved in the editorial review or the decision to publish this article. The other authors have no relevant financial or non-financial interests to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Introduction: Magnetic Resonance Elastography (MRE) allows the non-invasive quantification of tumor biomechanical properties in vivo . With increasing incidence of brain metastases, there is a notable absence of appropriate preclinical models to investigate their biomechanical characteristics. Therefore, the purpose of this work was to assess the biomechanical characteristics of B16 melanoma brain metastases (MBM) and compare it to murine GL261 glioblastoma (GBM) model using multifrequency MRE with tomoelastography post processing., Methods: Intracranial B16 MBM (n = 6) and GL261 GBM (n = 7) mouse models were used. Magnetic Resonance Imaging (MRI) was performed at set intervals after tumor implantation: 5, 7, 12, 14 days for MBM and 13 and 22 days for GBM. The investigations were performed using a 7T preclinical MRI with 20 mm head coil. The protocol consisted of single-shot spin echo-planar multifrequency MRE with tomoelastography post processing, contrast-enhanced T1- and T2-weighted imaging and diffusion-weighted imaging (DWI) with quantification of apparent diffusion coefficient of water (ADC). Elastography quantified shear wave speed (SWS), magnitude of complex MR signal (T2/T2*) and loss angle (φ). Immunohistological investigations were performed to assess vascularization, blood-brain-barrier integrity and extent of glucosaminoglucan coverage., Results: Volumetric analyses displayed rapid growth of both tumor entities and softer tissue properties than healthy brain (healthy: 5.17 ± 0.48, MBM: 3.83 ± 0.55, GBM: 3.7 ± 0.23, [m/s]). SWS of MBM remained unchanged throughout tumor progression with decreased T2/T2* intensity and increased ADC on days 12 and 14 (p<0.0001 for both). Conversely, GBM presented reduced φ values on day 22 (p=0.0237), with no significant alterations in ADC. Histological analysis revealed substantial vascularization and elevated glycosaminoglycan content in both tumor types compared to healthy contralateral brain., Discussion: Our results indicate that while both, MBM and GBM, exhibited softer properties compared to healthy brain, imaging and histological analysis revealed different underlying microstructural causes: hemorrhages in MBM and increased vascularization and glycosaminoglycan content in GBM, further corroborated by DWI and T2/T2* contrast. These findings underscore the complementary nature of MRE and its potential to enhance our understanding of tumor characteristics when used alongside established techniques. This comprehensive approach could lead to improved clinical outcomes and a deeper understanding of brain tumor pathophysiology., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Janas, Jordan, Bertalan, Meyer, Bukatz, Sack, Senger, Nieminen-Kelhä, Brandenburg, Kremenskaia, Krantchev, Al-Rubaiey, Mueller, Koch, Boehm-Sturm, Reiter, Zips, Vajkoczy and Acker.)

Objective: To evaluate the efficacy of the Fédération Internationale de Football Association (FIFA) cooling break policy against alternative cooling configurations in attenuating thermal strain during simulated football in the heat., Methods: 12 males (age: 27±6 years, V̇O 2peak : 61±7 mL/kg/min) completed five 90 min intermittent treadmill football match simulations in 40°C and 41% relative humidity (32°C wet-bulb globe temperature) with different cooling configurations: regular match without cooling breaks (REG), 3 min breaks without cooling (BRK no-cool ), 3 min breaks with cooling (BRK cool : current FIFA policy; chilled fluid ingestion and ice towel across neck and shoulders), 5 min extended half-time without cooling breaks (ExtHT only ) and 3 min cooling breaks with 5 min ExtHT (ExtHT cool ). Rectal temperature (T re ), heart rate, whole-body sweat rate (WBSR) and rating of perceived exertion (RPE) were recorded. Data are presented as mean (95% CIs)., Results: Final T re was lower in BRK no-cool (0.20°C (0.01, 0.39), p=0.038), BRK cool (0.39°C (0.21, 0.57), p<0.001) and ExtHT cool (0.40°C (0.22, 0.58), p<0.001) than REG (39.1°C (38.8, 39.3)). Mean T re was lower in ExtHT cool (38.2°C (38.0, 38.4)) than BRK cool (38.3°C (38.1, 38.5), p=0.018), BRK no-cool and ExtHT only (38.4°C (38.2, 38.6), p<0.001) and REG (38.5°C (38.3, 38.7), p<0.001). Mean heart rate was lower during BRK cool (6 beats/min (4, 7), p<0.001) and ExtHT cool (7 beats/min (6, 8), p<0.001) compared with REG. WBSR was comparable across trials (p ≥ 0.07) and RPE was attenuated during BRK cool (0.4 (0.1, 0.7), p=0.004) and ExtHT cool (0.5 (0.2, 0.7), p=0.002), compared with REG., Conclusion: BRK cool and ExtHT cool attenuated thermal, cardiovascular and perceptual strain during a simulated football match in the heat. Additional strategies may be required in field settings or under harsher conditions., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

A medium-to-high level of physical activity (PA) may have at least a short-term positive effect on psychopathology in children and adolescents. Hence, the objective of this study was to investigate the long-term effects of PA in non-adult age groups on their general mental health problems and/or ADHD symptoms, using trajectories of concurrent development over a period of 10 years. This study employed data from the German Health Interview and Examination Survey for Children and Adolescents (KiGGS) collected at three time points (baseline, Wave 1, Wave 2, over 10 years) from 17,640 children and adolescents. Using parent-reported data from the Strengths and Difficulties Questionnaire (SDQ), different developmental trajectories of general mental health problems (SDQ-total) and ADHD symptoms (SDQ-H/I) were identified with latent class mixed models (LCMM) statistics. This was also applied to parent- and self-reported data of three levels of PA. The latter was assessed according to WHO recommendations. The joint probability of class membership for SDQ-total as well as ADHD symptoms with PA was calculated to generate the concurrent developmental trajectories between variables. Results showed a 4-class trajectory model for both SDQ-total and ADHD symptoms among boys and girls. The majority of children and adolescents showed "low general difficulties" and "low ADHD symptoms" over the period of 10 years. Three distinct trajectories in boys and four distinct trajectories in girls were found for PA. Most of the participants showed an "increasing-decreasing activity" trajectory. No statistically significant correlations were found between the different SDQ-total or ADHD symptom trajectories and the trajectories of PA in the two genders. Taken together, our findings did not indicate any significant relationship between waxing and waning PA course over 10 years and various classes of mental health problems for children and adolescents. In contrast to our cross-sectional findings, no steady long-term medium/high-level of PA was present, which could (at least partly) explain the non-significant findings., (© 2024. The Author(s).)

Introduction/aims: In amyotrophic lateral sclerosis (ALS) caused by SOD1 mutations (SOD1-ALS), tofersen received accelerated approval in the United States and is available via expanded access programs (EAP) outside the United States. This multicenter study investigates clinical and patient-reported outcomes (PRO) and serum neurofilament light chain (sNfL) during tofersen treatment in an EAP in Germany., Methods: Sixteen SOD1-ALS patients receiving tofersen for at least 6 months were analyzed. The ALS progression rate (ALS-PR), as measured by the monthly change of the ALS functional rating scale-revised (ALSFRS-R), slow vital capacity (SVC), and sNfL were investigated. PRO included the Measure Yourself Medical Outcome Profile (MYMOP2), Treatment Satisfaction Questionnaire for Medication (TSQM-9), and Net Promoter Score (NPS)., Results: Mean tofersen treatment was 11 months (6-18 months). ALS-PR showed a mean change of -0.2 (range 0 to -1.1) and relative reduction by 25%. Seven patients demonstrated increased ALSFRS-R. SVC was stable (mean 88%, range -15% to +28%). sNfL decreased in all patients except one heterozygous D91A-SOD1 mutation carrier (mean change of sNfL -58%, range -91 to +27%, p < .01). MYMOP2 indicated improved symptom severity (n = 10) or yet perception of partial response (n = 6). TSQM-9 showed high global treatment satisfaction (mean 83, SD 16) although the convenience of drug administration was modest (mean 50, SD 27). NPS revealed a very high recommendation rate for tofersen (NPS +80)., Discussion: Data from this EAP supported the clinical and sNfL response to tofersen in SOD1-ALS. PRO suggested a favorable patient perception of tofersen treatment in clinical practice., (© 2024 The Author(s). Muscle & Nerve published by Wiley Periodicals LLC.)

People constantly compare their appearance and well-being to that of other individuals. However, a measure of social comparison of well-being is lacking and existing appearance-related social comparison assessment is limited to comparison tendency using predefined social situations. This limits our understanding of the role of social comparison in appearance and well-being. Therefore, we developed the Scale for Social Comparison of Appearance (SSC-A) and the Scale for Social Comparison of Well-Being (SSC-W) to assess upward and downward social comparisons with regard to (a) frequency, (b) perceived discrepancy to the standard, and (c) engendered affective impact during the last 3 weeks. In one longitudinal and three cross-sectional studies ( N s = 500-1,121), we administered the SSC-A or SSC-W alongside measures of appearance social comparison, body satisfaction, self-concept, social rank, well-being, envy, rumination, depression, and anxiety. Confirmatory factor analyses supported the expected two-factor model representing upward and downward social comparison for both scales. Overall, upward comparison displayed the anticipated associations with the measured constructs, whereas downward comparison showed mostly small or nonsignificant correlations with the validators. The SSC-A and SSC-W are efficient measures of social comparison for appearance and well-being with good evidence for their reliability and validity in our samples.