bluuebunny/crossref_metadata_2025_split huggingface dataset:
The German Version of the Satisfaction with Prosthesis Questionnaire: Translation, Adaptation, Reliability, and Validity in Adults with Major Lower-Limb Amputation
Authors: Wahl Beke , Gutenbrunner Christoph , Greitemann Bernhard , Oergel Marcus , Somoza López Diego , Schiller Jörg , Ranker Alexander 
Published: September 2021

ABSTRACT

Introduction
The aim of this study was to translate and cross-culturally adapt the Satisfaction with Prosthesis Questionnaire (SAT-PRO) into German and to evaluate its validity and reliability.

Materials and Methods
The 2-fold forward and backward translations were carried out according to the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines. Subsequently, the German version of the SAT-PRO was administered to 68 patients with major lower-limb amputation (LLA) fitted with a prosthesis. The internal consistency, floor and ceiling effects, item-to-total correlation, and test-retest reliability were determined. In addition, the standard error of the mean (SEM) and minimal detectable change (MDC) were calculated. Convergent construct validity was assessed by correlation to a Numerical Rating Scale for Satisfaction Level (NRS-SAT), the 36-Item Short-Form Health Survey (SF-36), the Rivermead Mobility Index (RMI), and the Medicare Functional Classification Level (K-Levels). Descriptive subgroup analysis included levels of amputation (transtibial vs. transfemoral persons with amputations) and user type (long-term vs. subacute users).

Results
The mean SAT-PRO total score was 32.27 ± 6.89 (77.6%). Internal consistency was high (Cronbach α = 0.88), and reproducibility demonstrated excellent findings with an intraclass correlation coefficient (ICC2,1) of 0.90 (95% confidence interval [CI], 0.84–0.94). Floor or ceiling effects were not detected. Convergent construct validity indicated a strong correlation to the NRS-SAT (r = 0.89), K-Levels (r = 0.66), and RMI (r = 0.52, all with P < 0.001). Moderate to high correlations were shown to all eight domains of the SF-36 (in a range of r = 0.55 [physical function] to r = 0.39 [mental health], all with P < 0.001). MDC was 2.32 (MDC% = 3.4%).

Conclusions
The translation according to ISPOR guidelines and cross-cultural adaptation of the SAT-PRO into German were successfully conducted in the pilot study. The psychometric testing showed high reliability and validity of the German version of the SAT-PRO. Hence, it can be used as an outcome measure to assess a patient's satisfaction with prosthesis in a German-speaking population.

Clinical Relevance Statement
The SAT-PRO can make an important contribution to the treatment of patients with major LLA. The use of objective measurement parameters and guideline-based translation should be applied to increase the validity and comparability of the data.
Learning Curves for Electromagnetic Navigation Bronchoscopy Using CUSUM Analysis
Authors: Toennesen Louise L. , Vindum Helene H. , Risom Ellen , Pulga Alexis , Nessar Rafi M. , Arshad Arman , Christophersen Alice , Konge Lars , Clementsen Paul F. 
Published: September 2021

Background:
Electromagnetic navigation bronchoscopy (ENB) is a relatively new and technically demanding procedure for the guidance of bronchoscopic biopsy to help locate small lung lesions. The results in experienced hands are well described. However, we do not know the results in unexperienced hands—in other words, we have no knowledge about how fast you can learn the procedure.

Aim:
The aim of this study was to draw learning curves for beginners in ENB using Cumulated Sum (CUSUM) analysis, a method for quantitative evaluation of the learning curves for clinical procedures.

Methods:
Four operators from 3 centers without prior ENB experience were enrolled. The outcome of consecutive ENB procedures was assessed and classified as either diagnostic or nondiagnostic based on sample adequacy. Learning curves were drawn based on diagnostic yield.

Results:
A total of 215 procedures were assessed. For 2 of the operators (operators 1 and 4), at least 25 to 30 procedures were necessary to obtain competency whereas operators 2 and 3 showed more horizontal learning curves indicating an overweight of diagnostic procedures from the beginning.

Conclusion:
Operators achieve competences in ENB at different paces. This must be taken in account when beginners start to learn the procedure. There is a huge need for a structured educational program and a validated test to determine competences.
Timing of renal-replacement therapy in intensive care unit-related acute kidney injury
Authors: Jeong Rachel , Wald Ron , Bagshaw Sean M. 
Published: September 2021

Purpose of review
The optimal timing of renal-replacement therapy (RRT) initiation for the management of acute kidney injury (AKI) in the intensive care unit (ICU) is frequently controversial. An earlier-strategy has biological rationale, even in the absence of urgent indications; however, a delayed-strategy may prevent selected patients from receiving RRT and avoid complications related to RRT.

Recent findings
Previous studies assessing the optimal timing of RRT initiation found conflicting results, contributing to variation in clinical practice. The recent multinational trial, standard vs. accelerated initiation of renal replacement therapy in acute kidney injury (STARRT-AKI) found no survival benefit and a higher risk of RRT dependence with an accelerated compared to a standard RRT initiation strategy in critically ill patients with severe AKI. Nearly 40% of patients allocated to the standard-strategy group did not receive RRT. The Artificial Kidney Initiation in Kidney Injury-2 (AKIKI-2) trial further assessed delayed compared to more-delayed strategies for RRT initiation. The more-delayed strategy did not confer an increase in RRT-free days and was associated with a higher risk of death.

Summary
Early preemptive initiation of RRT in critically ill patients with AKI does not confer clear clinical benefits. However, protracted delays in RRT initiation may be harmful.
Serum Levels of PCSK9 Are Increased in Patients With Active Ulcerative Colitis Representing a Potential Biomarker of Disease Activity
Authors: Marinelli Carla , Zingone Fabiana , Lupo Maria Giovanna , Marin Raffaella , D’Incà Renata , Gubbiotti Alessandro , Massimi Davide , Casadei Cesare , Barberio Brigida , Ferri Nicola , Savarino Edoardo 
Published: September 2021

Background/Goal:
Ulcerative colitis (UC) is characterized by chronic inflammation and progressive course, with potential extraintestinal complications including cardiovascular mortality. Serum proprotein convertase subtilisin/kexin type 9 (PCSK9) levels have been recently recognized as biomarkers of low-grade inflammation and cardiovascular disease. The aim of our study was to evaluate PCSK9 levels in patients with UC and different degrees of disease activity.

Methods:
We prospectively recruited consecutive patients with UC attending our center at the University Hospital of Padua. Demographics, clinical characteristics, and biochemical data, including PCSK9, high sensitivity C-reactive protein, and fecal calprotectin, were recorded. Moreover, endoscopic procedures were performed in all subjects.

Results:
We included 112 patients with UC (mean age=52.62±12.84 y; 52.62% males). Patients with UC and abnormal fecal calprotectin (≥250 µg/g) and/or C-reactive protein (≥3 mg/L) had greater levels of PCSK9 compared with UC patients with normal fecal calprotectin and high sensitivity C-reactive protein (P=0.03 and 0.005, respectively). Higher endoscopic scores in UC were characterized by greater levels of PCSK9 (P=0.03). Furthermore, we found a positive correlation between PCSK9 levels and fecal calprotectin (r=0.18, P=0.04), endoscopic Mayo Score (r=0.25, P=0.007), and UC-Riley Index (r=0.22, P=0.01). We also found a positive correlation between PCSK9 levels and both total and low-density lipoprotein cholesterol values (P<0.05).

Conclusions:
Serum PCSK9 levels are increased in patients with biochemical and endoscopic evidence of active disease in UC. Further longitudinal studies are necessary to evaluate the role of PCSK9 as a potential biomarker of disease activity and cardiovascular risk in UC.
Significance of validated symptom assessment versus breath testing for malabsorption after lactose load in children
Authors: Sterniste Georg , Hammer Karin , Memaran Nima , Huber Wolf-Dietrich , Hammer Johann 
Published: September 2021

Background and objectives
Lactose malabsorption and lactose-induced symptoms are poorly correlated, as shown by breath tests and various symptom assessment methods. Validated assessment is the key to overcome the limitations of biased symptom measurements. We characterized lactose-induced symptoms with the population-specific, validated paediatric carbohydrate perception questionnaire (pCPQ) and their correlation with the history of symptoms (HoS).

Methods
A total of 130 patients with functional gastrointestinal symptoms underwent a lactose hydrogen breath and tolerance test (LBTT) allowing for a diagnosis of malabsorption (M+) and lactose sensitivity (S+). HoS indicative of lactose-induced symptoms (abdominal pain, nausea, bloating, flatulence, diarrhoea) in the 4 weeks preceding the test was determined using a validated questionnaire. The pCPQ was used to score lactose-induced symptoms.

Main results
The LBTT revealed 41 children (31.5%) with lactose malabsorption (M+), 56 (43.1%) with lactose sensitivity (S+) and 24 (18.5%) were M+/S+. Sensitivity correlated with HoS (P < 0.001), regardless of whether malabsorption was detectable. Malabsorption status did not correlate with HoS (NS). The odds of lactose sensitivity significantly increased when abdominal pain [odds ratio (OR) 3.5, confidence interval (CI) 1.6–7.8], nausea (OR 2.3, CI, 1.1–4.9) and flatulence (OR 3.1, CI 1.4–6.8) were reported in the 4 weeks preceding the LBTT. Symptoms after the lactose load were similar for M+/S+ and M−/S+, except for flatulence, which was more frequent in malabsorbers (P < 0.01).

Conclusion
Our findings fit well with the emerging view of the important role of a validated symptom assessment after a lactose load. The determination of symptoms may be more relevant than malabsorption for the clinical outcomes of paediatric patients with lactose-related gastrointestinal symptoms.
Safety and efficacy of sofosbuvir/ledipasvir and sofosbuvir/daclatasvir in the treatment of hepatitis C in patients with decompensated cirrhosis
Authors: El Kassas Mohamed , Abdeen Nermeen , Omran Dalia , Alboraie Mohamed , Salaheldin Mohamed , Eltabbakh Mohamed , Farghaly Rasha , Emadeldeen Mohammed , Afify Shimaa , Sweedy Ahmad , Ghalwash Ahmed , Abbass Amr , Ezzat Sameera , Tahoon Marwa , ELshazly Helmy M. , Hamdy Hassan , Omar Heba 
Published: September 2021

Background
Hepatitis C virus (HCV)-related decompensated cirrhosis is a severe life-threatening illness. The safety of direct-acting antivirals (DAAs) has opened a gate of hope for that subgroup of patients who were previously contraindicated for interferon therapy.

Objective
We aimed at the investigation of the safety and efficacy of different DAAs regimens in the treatment of HCV-related decompensated cirrhosis patients, to determine sustained virological response (SVR)12 rates and to analyze the factors associated with response.

Methods
A retrospective, single-center study including HCV-related decompensated cirrhosis patients who received DAAs. Demographic, laboratory and clinical data were analyzed. The SVR12 rate was the primary outcome measure. Secondary outcomes included the predictors of response, changes in the baseline model for end-stage liver disease and child-turcotte-pugh (CTP) scores, and fibroindices (APRI and fibrosis-4 index) at 12 weeks after treatment.

Results
In total, 145 eligible patients (141 with CTP class B and 4 with class C) were enrolled in this study. SVR12 was achieved by 88.06% (118/134) of efficacy population on different DAAs regimens, Treatment was discontinued in 11 patients because of severe side effects without any deaths. Younger age showed a significant positive association with SVR12.

Conclusions
DAAs can be used for the treatment of HCV-related decompensated liver disease, with acceptable SVR12 rates and safety profiles.
Healthcare practitioners’ diagnostic and treatment practice patterns of nonalcoholic fatty liver disease in Poland: a cross-sectional survey
Authors: Hartleb Marek , Mastalerz-Migas Agnieszka , Kowalski Piotr , Okopień Bogusław , Popovic Branko , Proga Katarzyna , Cywińska-Durczak Beata 
Published: September 2021

Background
Nonalcoholic fatty liver disease (NAFLD) awareness is low. NAFLD diagnosis and management by gastroenterologists (GEs) and general practitioners (GPs) in Poland were evaluated.

Methods
RESTORE was an observational, noninterventional, retrospective cross-sectional survey performed among GEs and GPs with at least 3 years’ experience. Computer-assisted web interviews were completed. GEs provided information from patient records.

Results
Mean experience was 14.2 (95 GEs) and 22.6 (115 GPs) years. Mean patient numbers with liver disorders consulted per month were 36 (13%; GEs) and 51 (6%; GPs); ~50% were patients with NAFLD. All GEs/GPs used ultrasound; most evaluated transaminases and gamma-glutamyl transferase. More GEs used other imaging techniques and a larger spectrum of laboratory tests than GPs. Physician-identified NAFLD key symptoms were similar for GEs/GPs. GEs noticed less obvious symptoms (abdominal discomfort, drowsiness, fatigability, lack of energy) vs. GPs (abdominal pain/discomfort, dyspepsia). Common comorbidities in NAFLD were similar in GE/GP responses. NAFLD interventions by GEs/GPs (% patients) were diet/lifestyle/pharmacological interventions (54%/59%), diet/lifestyle changes alone (41%/31%) or pharmacological interventions alone (5%/10%). The top three criteria for supportive pharmacological selection were efficacy, tolerability and quality of life improvement for GEs/GPs. The five supportive treatments most commonly prescribed by GEs/GPs were essential phospholipids, ursodeoxycholic acid, timonacic, silybinin/silymarin and ornithine + choline. Information from patient records (n = 380) confirmed GEs responses.

Conclusions
NAFLD is not a silent disease as physicians and patients reported many, albeit nonspecific, symptoms. This cross-sectional survey provides important insights into clinical management of NAFLD by GEs and GPs in Poland.
Gastroparesis
Authors: Cangemi David J. , Lacy Brian E. 
Published: September 2021

Purpose of review
This review highlights recent research advances regarding the pathophysiology and treatment of gastroparesis.

Recent findings
Differences in brain activity have been identified on functional MRI imaging in gastroparesis patients with nausea. Abdominal pain is common in patients with gastroparesis and does not correlate with the severity of gastric emptying delay, though may be associated with depression and anxiety. Autonomic dysfunction may play an important role in the pathophysiology of gastroparesis. There is increasing sentiment that gastroparesis should be considered a part of the same spectrum of gastric neuromuscular disorders. The risk of tardive dyskinesia with metoclopramide has likely been significantly overestimated historically. Endoscopic BoTox injection of the pylorus and gastric electrical stimulation remain controversial treatments for gastroparesis. New, highly selective 5-hydroxytryptamine 4 (5-HT4) agonists appear safe and may be effective in improving symptoms of gastric emptying. Long-term data assessing the use of gastric peroral endoscopic myotomy (G-POEM) for the treatment of refractory gastroparesis suggest durable clinical improvement.

Summary
Altered central processing and autonomic dysfunction may be important factors in the pathogenesis of gastroparesis. While the risk of tardive dyskinesia appears much lower than historically advertised, there is increasing hope for novel therapeutics with the advent of new 5-HT4 agonists, neurokinin-1 receptor (N1KR) antagonists, and G-POEM.
The power of lipid registries for cardiovascular disease prevention
Authors: Nishikido Toshiyuki , Ray Kausik K. 
Published: September 2021

Purpose of review
Lipid registry-based research is a valuable tool for assessing current lipid management in patients at risk of cardiovascular disease (CVD). Results of several registries are useful for improving clinical practice highlight gaps between guidelines and their implementation and potential impact on population health. We summarize recent clinical studies based on lipid registries.

Recent findings
Current guidelines for lipid management recommend high-intensity statins and concomitant therapies such as ezetimibe and proprotein convertase subtilisin-kexin type 9 inhibitors for high-risk patients. However, recent observational studies show that the majority of patients received inadequate lipid-lowering therapy (LLT), and the low-density lipoprotein-cholesterol (LDL-C) goal attainment rates are still unsatisfactory.

Summary
There is a clear gap between lipid guidelines and lipid management in clinical practice. Clinical studies based on registry databases represent real-world conditions, as opposed to clinical trials. Contemporary registry data reveal that only half of the patients received high-intensity statins, and less than half achieve the LDL-C <70 mg/dL in secondary prevention. In addition, the major reasons for insufficient therapy have been shown to be not only side effects of LLT, but poor adherence by patients to medication regimens and low use of combination therapies by physicians. The real-world evidence from lipid registries clarifies gaps, areas for focus for implementation, to improve CVD prevention.
Coronavirus disease 2019 in patients with inborn errors of immunity: lessons learned
Authors: Bucciol Giorgia , Tangye Stuart G. , Meyts Isabelle 
Published: September 2021

Purpose of review
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has caused extreme concern for patients with inborn errors of immunity (IEIs). In the first 6  months of the pandemic, the case fatality rate among patients with IEIs resembled that of the general population (9%). This review aims at summarizing what we have learned about the course and outcome of coronavirus disease 2019 (COVID-19) in patients with different IEIs and what this can potentially teach us about the immune mechanisms that could confer protection or predisposition to severe disease.

Recent findings
A total of 649 patients with IEI and COVID-19 have been reported in the last year and a half, spanning all groups of the International Union of Immunological Societies classification of IEIs. For most patients, the underlying IEI does not represent an independent risk factor for severe COVID-19. In fact, some IEI may even be protective against the severe disease due to impaired inflammation resulting in less immune-mediated collateral tissue damage.

Summary
We review the characteristics of SARS-CoV-2 infection in a large number of patients with IEI. Overall, we found that combined immunodeficiencies, immune dysregulation disorders, and innate immune defects impairing type I interferon responses are associated with severe disease course.
The effect of coronavirus disease 2019 on newborns
Authors: Kyle Margaret H. , Dumitriu Dani 
Published: September 2021

Purpose of review
To evaluate the available literature regarding effects of coronavirus disease 2019 (COVID-19) on newborns, ranging from effects related to in utero and perinatal exposure to maternal severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, to pandemic-related stress and socioeconomic changes.

Recent findings
Several large studies and national registries have shown that the risk of vertical transmission from SARS-CoV-2-infected mothers to newborns is rare and does not appear to be related to postnatal care policies such as mother–newborn separation and breastfeeding. Newborns exposed to SARS-CoV-2 in utero are at higher risk for preterm delivery for reasons still under investigation. When newborns do acquire SARS-CoV-2 infection, their disease course is usually mild. Long-term follow-up data are lacking, but preliminary reports indicate that, similarly to prior natural disasters, being born during the pandemic may be associated with developmental risk.

Summary
Although risk of vertical or perinatal transmission is low across a range of postnatal care practices, early indicators suggest developmental risk to the generation born during the pandemic. Long-term follow-up data are critically needed to determine the developmental impact of in utero and early life exposure to SARS-CoV-2 and the COVID-19 pandemic.
Microbiota in heart and lung transplantation: implications for innate-adaptive immune interface
Authors: Bai Yun Zhu , Roberts Sophia H. , Kreisel Daniel , Nava Ruben G. 
Published: September 2021

Purpose of review
Transplantation continues to be the only treatment option for end-stage organ failure when other interventions have failed. Although short-term outcomes have improved due to advances in perioperative care, long-term outcomes continue to be adversely affected by chronic rejection. Little is known about the role microbiota play in modulating alloimmune responses and potentially contributing to graft failure. Initial data have identified a correlation between specific changes of the recipient and/or donor microbiota and transplant outcomes. In this review, we will focus on recent findings concerning the complex interplay between microbiota and the innate immune system after heart and lung transplantation.

Recent findings
Gut microbiome derangements in heart failure promote an inflammatory state and have lasting effects on the innate immune system, with an observed association between increased levels of microbiota-dependent metabolites and acute rejection after cardiac transplantation. The lung allograft microbiome interacts with components of the innate immune system, such as toll-like receptor signalling pathways, NKG2C+ natural killer cells and the NLRP3 inflammasome, to alter posttransplant outcomes, which may result in the development of chronic rejection.

Summary
The innate immune system is influenced by alterations in the microbiome before and after heart and lung transplantation, thereby offering potential therapeutic targets for prolonging allograft survival.
Diagnosis and Management of Oral Extraintestinal Manifestations of Pediatric Inflammatory Bowel Disease
Authors: Shazib Muhammad Ali , Byrd Kevin M. , Gulati Ajay S. 
Published: September 2021

ABSTRACTInflammatory bowel diseases (IBD) represent a group of chronic inflammatory disorders of the gastrointestinal tract that lead to impaired quality of life and substantial health care costs. Up to 50% of pediatric IBD cases present with manifestations in the oral cavity. These may develop in nearly every oral tissue, including the soft tissues, tongue, lips, teeth, and lymph nodes. The goal of this review is to offer a systematic approach to diagnose and manage commonly encountered oral manifestations of pediatric IBD. This knowledge is critical for enhancing the comprehensive care and quality of life of children with these debilitating diseases.