bluuebunny/crossref_metadata_2025_split huggingface dataset:
Ventilator-Associated Lower Respiratory Tract Bacterial Infections in COVID-19 Compared With Non-COVID-19 Patients*
Authors: Hedberg Pontus , Ternhag Anders , Giske Christian G. , Strålin Kristoffer , Özenci Volkan , Johansson Niclas , Spindler Carl , Hedlund Jonas , Mårtensson Johan , Nauclér Pontus 
Published: February 2022

OBJECTIVES:
Ventilator-associated lower respiratory tract infections (VA-LRTIs) are associated with prolonged length of stay and increased mortality. We aimed to investigate the occurrence of bacterial VA-LRTI among mechanically ventilated COVID-19 patients and compare these findings to non-COVID-19 cohorts throughout the first and second wave of the pandemic.

DESIGN:
Retrospective cohort study.

SETTING:
Karolinska University Hospital, Stockholm, Sweden.

PATIENTS:
All patients greater than or equal to 18 years treated with mechanical ventilation between January 1, 2011, and December 31, 2020.

INTERVENTIONS:
None.

MEASUREMENTS AND MAIN RESULTS:
The cohort consisted of 20,223 ICU episodes (479 COVID-19), with a VA-LRTI incidence proportion of 30% (129/426) in COVID-19 and 18% (1,081/5,907) in non-COVID-19 among patients ventilated greater than or equal to 48 hours. The median length of ventilator treatment for COVID-19 patients was 10 days (interquartile range, 5–18 d), which was significantly longer than for all other investigated specific diagnoses. The VA-LRTI incidence rate per 1,000 ventilator days at risk was 31 (95% CI, 26–37) for COVID-19 and 34 (95% CI, 32–36) for non-COVID-19. With COVID-19 as reference, adjusted subdistribution hazard ratios for VA-LRTI was 0.29–0.50 (95% CI, < 1) for influenza, bacterial pneumonia, acute respiratory distress syndrome, and severe sepsis, but 1.38 (95% CI, 1.15–1.65) for specific noninfectious diagnoses. Compared with COVID-19 in the first wave of the pandemic, COVID-19 in the second wave had adjusted subdistribution hazard ratio of 1.85 (95% CI, 1.14–2.99). In early VA-LRTI Staphylococcus aureus was more common and Streptococcus pneumoniae, Haemophilus influenzae, and Escherichia coli less common in COVID-19 patients, while Serratia species was more often identified in late VA-LRTI.

CONCLUSIONS:
COVID-19 is associated with exceptionally long durations of mechanical ventilation treatment and high VA-LRTI occurrence proportions. The incidence rate of VA-LRTI was compared with the pooled non-COVID-19 cohort, however, not increased in COVID-19. Significant differences in the incidence of VA-LRTI occurred between the first and second wave of the COVID-19 pandemic.
Effects of Carbon Fiber Foot Plate on Able-bodied Gait: Pilot Study
Authors: Premprasopchok Yuparat , Sukthomya Sasithon , Petmunee Wareerat , Rayothee Pitchaya , Permpool Kwannate , Eh Saw Naing Naing , Utami Feryanda 
Published: February 2022

ABSTRACT

Introduction
Foot orthoses have injury prevention and human performance benefits. The carbon fiber foot plate (CFFP) is a possible orthotic intervention for preventing foot injury and enhancing sports performance. However, the cost of these devices is generally acceptable for developed settings but might serve as a barrier for use in developing settings. In this study, we aimed to develop an affordable locally custom-made CFFP and evaluate its function along with subjective feedback.

Materials and Methods
Three types of foot plates were designed each with a unique layup and fabric orientation. Carbon fiber preimpregnated with activated resin was used for foot plate fabrication. Three participants were provided with each prototype of the foot plate. Outcome measurements include walking speed (20-m walk test [20MWT]), treadmill jogging energy expenditure, and user feedback.

Results
The 20MWT self-selected speed increased for two participants with the CFFP. The maximum average walking speed increased in two participants with CFFP prototype B (8%–11%). Moreover, the average increase of walking speed for prototypes A and C were 2%–2.6% and 4%–4.6%, respectively. The third participant showed a 5% reduction of speed with CFFP prototype B and 3%–5% with prototypes A and B. For all participants, no improvements of energy expenditure were observed with all prototypes compared to without foot plate. Conversely, an increase in energy expenditure was found with all prototypes at all speeds. The subjective feedback in each prototype showed that all participants were satisfied with the CFFP prototype A, but the first participant was identified with metatarsal head pain.
Prototype B also evidenced a consensus among participants with increased comfort compared with prototype A, especially at the metatarsal heads.

Conclusions
The study describes the development and effects of using three types of CFFPs. Although prototypes increased the energy expenditure, prototype B improved walking speed. Prototypes A and B were useful and accepted by all participants. Further exploration is required in a larger heterogeneous sample of able-bodied persons and sport-specific athletes.

Clinical Relevance
The study demonstrates the effect of the CFFP on walking ability, which can better inform the clinician when considering the prescription for patients with foot problems and sports activities.
Association of a telephone triage service for emergency patients with better outcome: a population-based study in Osaka City, Japan
Authors: Katayama Yusuke , Kitamura Tetsuhisa , Nakao Shunichiro , Tanaka Kenta , Himura Hoshi , Deguchi Ryo , Tai Shunsuke , Tsujino Junya , Mizobata Yasumitsu , Shimazu Takeshi , Nakagawa Yuko 
Published: February 2022

Objective
Telephone triage service in emergency care has been introduced in many countries, and it is important to determine the effect of telephone triage service on the outcome of emergency patients. The aim of this study was to evaluate the effect of telephone triage service on the outcome of emergency patients using propensity score.

Methods design, settings, and participants
This was a retrospective study with a study period from January 2016 to December 2019. We included all patients transported by ambulances of the Osaka Municipal Fire Department during study period.

Exposure
Telephone triage service.

Outcome measures and analysis
The main outcome of this study was unfavorable outcome following use of the telephone triage service. In this study, unfavorable outcome was defined as patients who were admitted, transferred, or died after care in the emergency department. Propensity scores were calculated using a logistic regression model with 12 variables that were present before the telephone triage service was used or were indicative of the patient’s condition. Data analyses were not only propensity score matching but also a multivariable logistic regression model and regression model with propensity score as a covariate.

Main results
The number of patients eligible for analyses was 707 474. Of these patients, 8008 (1.0%) used the telephone triage services and 699 466 patients (99.0%) did not use it. The number of patients with an unfavorable outcome was 407 568 (57.6%) in the total cohort. Of them, 2305 patients (28.8%) used the telephone triage service and 297 601 patients (42.5%) did not use it. For propensity score matching, 8008 patients were matched from each group. Use of the telephone triage service was inversely associated with unfavorable outcome in a multivariate logistic regression model with propensity score as a covariate [adjusted odds ratio (OR) 0.874; 95% confidence interval (CI), 0.831–0.919] and propensity score matching (crude OR, 0.875; 95% CI, 0.818–0.936).

Conclusions
This study revealed that the use of the telephone triage service in Osaka city, Japan was associated with better outcomes of patients transported by ambulance.
The Prescription Drug User Fee Act
Authors: Mitchell Aaron P. , Trivedi Niti U. , Bach Peter B. 
Published: February 2022

Background:
The Prescription Drug User Fee Act (PDUFA) is due for reauthorization in 2022. Beyond creating the user fee program which now generates a majority of the Food and Drug Administration (FDA) Human Drugs Program budget, PDUFA has made numerous additional changes to FDA policy during its 29-year history. FDA’s budgetary dependence on user fees may advantage the industry in negotiating favorable policy changes through PDUFA.

Methods:
The full texts of all prior PDUFA reauthorization bills and all submitted public comments and meeting minutes for the 2022 reauthorization were reviewed. Provisions affecting FDA regulatory authority and processes were identified.

Findings:
PDUFA legislation has instituted a broad range of changes to FDA policy, including evidentiary standards for drug approval, accelerated pathways for approval, industry involvement in FDA decision-making, rules regarding industry information dissemination to providers, and market entry of generic drugs. Negotiations over the 2022 reauthorization suggest that industry priorities include increased application of real-world evidence, regulatory certainty, and increased communication between FDA and industry during the drug application process.

Conclusions:
The need for PDUFA reauthorization every 5 years has created a recurring legislative vehicle through which far-ranging changes to FDA have been enacted, reshaping the agency’s interactions and relationship with the regulated industry. The majority of policy changes enacted through PDUFA legislation have favored industry through decreasing regulatory standards, shortening approval times, and increasing industry involvement in FDA decision-making. FDA’s budgetary dependence on the industry, the urgency of each PDUFA reauthorization’s passage to maintain uninterrupted funding, and the industry’s required participation in PDUFA negotiations may advantage the industry.
Landscape of Pediatric Endoscopic Ultrasound in a United States Tertiary Care Medical Center
Authors: Barakat Monique T. , Cagil Yasemin , Gugig Roberto 
Published: February 2022

ABSTRACTBackground:Endoscopic ultrasound (EUS) is a commonly used radiation‐sparing procedure in adult patients for diagnostic sampling of gastrointestinal lesions and fluid collections, gastric variceal hemostasis, biliary/pancreatic duct drainage, and endo‐surgical interventions. Integration of EUS in pediatrics is still in its infancy with limited data regarding its use. The present study analyzes utilization, diagnostic and therapeutic roles of pediatric EUS and evolution in these parameters over time.Methods:Records of patients 18 years or younger from 2009 to 2020 at our tertiary pediatric care center were retrospectively identified. Patient demographics, symptoms, laboratory studies, EUS indications and interventions, and clinical outcomes of the procedures were analyzed. Statistical analysis was performed using Student t‐test, Pearson's chisquare and Fisher exact tests.Results:306 EUS procedures were performed during the study period, for 279 pediatric patients. These included 287 (93.8%) upper EUS and 19 (6.2%) lower EUS. Two hundred and twenty‐nine procedures were diagnostic (74.8%) and 77 were therapeutic (25.2%). EUS indications included evaluation and therapy of the pancreaticobiliary region (231, 75.5%), subepithelial or regional lesion (54, 17.8%), celiac plexus block (19, 6.2%) and hemostasis (14, 4.5%). Diagnostic sampling was performed in 52 of these EUS procedures, with a 96.2% diagnostic yield. 98.7% of therapeutic procedures were technically successful and there were no associated adverse events.Conclusion:The diagnostic and therapeutic role for EUS in adults has expanded dramatically, however the role of EUS in pediatrics is not well‐defined. In this, the largest pediatric EUS study to date, our data support the safety and utility of diagnostic and therapeutic EUS in pediatrics.
Randomized Controlled Trial of Interactive Spaced Education to Support Constipation Management by Pediatric Primary Care Providers
Authors: Mallon Daniel , Fei Lin , Farrell Michael , Anderson Jeffrey B. , Klein Melissa 
Published: February 2022

ABSTRACTIntroduction:Integrating continuing medical education and quality improvement (QI) initiatives is challenging. We aimed to compare one method, Interactive Spaced Education (ISE/QI), with standard (sTD/Qi) education embedded within a constipation management Qi initiative.Methods:We conducted a randomized, controlled study to compare ISE/QI and STD/QI education. Pediatric primary care providers (PCPs) were recruited from a network of local private practices. The QI initiative was implemented with all providers before education interventions. ISE/QI participants received questions by email weekly, provided answers, received feedback, and repeated questions over a 4‐month period. The STD/QI group received a Power Point with the same educational content. Pre‐ and post‐surveys evaluated usability, self‐assessed confidence, and practice changes while quizzes evaluated knowledge. Process control charts tracked subsequent visits to gastroenterology (GI).Results:Of the 212 eligible PCPs, 101 (48%) enrolled, with 49 PCPs in the ISE/QI arm and 52 in STD/QI education arm. Quiz scores improved in the ISE/QI arm with a strong effect size (Cohen d 1.76). Mean increase in confidence managing difficult cases was higher in the ISE/QI group (1.84 vs 1.21, P = 0.030). ISE/QI participants were more likely to rate the activity better than most online education (odds ratio [OR] 18.1, P < 0.0001) and incorporate practice changes (OR 3.35, P = 0.0152). Visits to GI decreased among the entire population, but the effect on GI visits within each education arm was mixed.Conclusions:ISE/QI improved knowledge and confidence managing difficult cases. ISE/QI participants reported higher likelihood to change practice, but no differences were seen in GI referrals.
Ledipasvir‐sofosbuvir in Adolescents With Chronic Hepatitis C and Hematological Malignancies Undergoing Chemotherapy
Authors: El‐Sayed Manal Hamdy , Ebeid Fatma S. Elsayed , Zekri Abdel‐Rahman , Massetto Benedetta , Kersey Kathryn , Zhang Fangqiu , Gaggar Anuj , Elsayed Walaa , El‐Haddad Alaa 
Published: February 2022

ABSTRACTObjectives:In children with hematological malignancies, chronic hepatitis C virus (HCV) infection has been associated with more rapid liver disease progression and higher risk of malignancy relapse due to chemotherapy interruption. We evaluated the safety and efficacy of ledipasvir‐sofosbuvir for 12weeks in these patients.Methods:In a phase 2, open‐label study, at one site in Egypt, patients ages 12‐<18years with chronic HCV genotype 1 or 4 infection undergoing maintenance chemotherapy for hematological malignancies received ledipasvir‐sofosbuvir (90 mg/400 mg) once daily for 12weeks. The efficacy endpoint was sustained virologic response 12 weeks after treatment (SVR12). Safety was assessed by the incidence of adverse events and clinical and laboratory data, including HCV flares defined as alanine aminotransferase >3‐fold increase from Day 1 and HCV RNA elevation >1 × log10 from Day 1.Results:Of the 19 adolescents enrolled and treated, median age was 14 years (range 12–17), 84% (16/19) were male, and all had HCV genotype 4 and were HCV treatment naive. All patients completed treatment and achieved SVR12 (19/19, 100%, 95% confidence interval, 82–100). Common adverse events were pyrexia (5/19, 26%), diarrhea (4/19, 21%), and headache (4/19, 21%). Three patients experienced serious adverse events of pneumonia (two patients), and osteoarthritis and diarrhea (one patient); none were considered related to study drug. No patient experienced HCV flares.Conclusions:Ledipasvir‐sofosbuvir was well‐tolerated and efficacious in adolescents with chronic HCV genotype 4 and leukemia undergoing maintenance chemotherapy. These data support the use of this interferon and ribavirin‐free regimen in adolescents with hematological malignancies.
Simplified Magnetic Resonance Index of Activity Is Useful for Terminal Ileal but not Colonic Disease in Pediatric Crohn Disease
Authors: Lepus Chelsea A. , Moote Douglas J. , Bao Shanshan , Mosha Maua H. , Hyams Jeffrey S. 
Published: February 2022

ABSTRACTBackground:Ileocolonoscopy (IC) detects mucosal inflammation and magnetic resonance enterography (MRE) detects transmural inflammation in Crohn disease (CD). We aimed to evaluate the relationship between the simplified magnetic resonance index of activity (MARIAs) and measures of inflammation by IC in children with newly diagnosed CD.Methods:Retrospective review of 140 patients 6–18 years of age with CD who had baseline IC and MRE within 5 weeks of diagnosis. MARIAs was calculated for each intestinal segment (terminal ileum [TI], ascending colon, transverse colon, descending colon, sigmoid colon, rectum), defined as (1 × thickness > 3 mm) + (1 × edema) + (1 × fat stranding) + (2 × ulcers). Sensitivity and specificity were derived using receiver operating characteristic (ROC) curves to compare MARIAs to IC findings.Results:Using IC as the reference standard, the cutoff MARIAs ≥1 identified TI segments with active inflammation with 84% sensitivity, 73% specificity, 85% positive predictive value (PPV), 70% negative predictive value (NPV), and area under the curve (AUC) 0.782 (95% confidence interval [CI] 0.689–0.876). The cutoff MARIAs ≥2 identified TI segments with severe lesions with 87% sensitivity, 76% specificity, 87% PPV, 76% NPV, and AUC 0.814 (95% CI 0.712–0.916). There was poor sensitivity for all colonic segments.Conclusion:The MARIAs is feasible and accurate in reflecting disease activity in the TI, but not in the colon, in children with newly diagnosed CD. Although the MARIAs may be useful for monitoring TI disease activity over time, full assessment continues to require both IC and MRE.
Experiences With COVID-19
Authors: Prokop Jackie , Reid Catherine , Palmateer Brandon 
Published: February 2022

Background
Millions of Americans have tested positive for COVID-19. The illness has a range of clinical symptoms with varying degrees of symptom severity; there is limited research about the lived experience of having COVID-19.

Objective
The study aim was to understand the lived experience of having COVID-19, provide detail on the length and severity of symptoms as well as coping mechanisms of those with the illness, and identify issues individuals face when accessing healthcare.

Methods
This phenomenological qualitative study included semistructured interviews of 45 people ages 18 years and older living in the United States who tested positive for COVID-19. Inductive content analysis was employed for subjective interpretation of the text through a systematic coding classification to identify themes for analysis and conclusions.

Results
This study details a variety of symptom presentations of individuals who tested positive for COVID-19 as well as mental health concerns related to fear and living with COVID-19.

Discussion
Individuals expressed varying emotions when finding they tested positive for COVID-19. Many conveyed fear of having COVID-19 and indicated it was a traumatic experience. This fear is an important clinical finding that policymakers and providers should consider when treating acute and chronic COVID-19 patients. Finally, many participants, commonly referred to as “long haulers,” experienced ongoing and lingering symptoms highlighting an area in need of further research.
Case Report: Acute Corneal Hydrops despite Accelerated Transepithelial Corneal Cross-linking
Authors: Meyer Jay J. , Gokul Akilesh 
Published: February 2022

SIGNIFICANCE
Corneal cross-linking is a well-established treatment to reduce or halt the progression of keratoconus. This case demonstrates that acute corneal hydrops may develop several years after corneal cross-linking even despite apparent treatment effect with corneal flattening, and patients should be monitored accordingly.

PURPOSE
This study aimed to describe a case of continued progression in the form of corneal hydrops despite prior corneal cross-linking and evidence of treatment effect.

CASE REPORT
A 19-year-old woman underwent bilateral accelerated transepithelial corneal cross-linking for progressive keratoconus. At 2 years after the procedure, significant flattening of the central cornea of >3 D was measured in the left eye, indicating a significant treatment response, although continued thinning was noted on tomography. At 3.5 years after the procedure, this eye developed acute corneal hydrops with subsequent corneal scarring necessitating corneal transplantation.

CONCLUSIONS
Patients should continue to be monitored for several years after corneal cross-linking, and retreatment should be considered if there is progressive corneal thinning.
Successive Wave Analysis to Assess Nonresponse Bias in a Statewide Random Sample Testing Study for SARS-CoV-2
Authors: Duszynski Thomas J. , Fadel William , Dixon Brian E. , Yiannoutsos Constantin , Halverson Paul K. , Menachemi Nir 
Published: February 2022

Introduction:
Nonresponse bias occurs when participants in a study differ from eligible nonparticipants in ways that can distort study conclusions. The current study uses successive wave analysis, an established but underutilized approach, to assess nonresponse bias in a large-scale SARS-CoV-2 prevalence study. Such an approach makes use of reminders to induce participation among individuals. Based on the response continuum theory, those requiring several reminders to participate are more like nonrespondents than those who participate in a study upon first invitation, thus allowing for an examination of factors affecting participation.

Methods:
Study participants from the Indiana Population Prevalence SARS-CoV-2 Study were divided into 3 groups (eg, waves) based upon the number of reminders that were needed to induce participation. Independent variables were then used to determine whether key demographic characteristics as well as other variables hypothesized to influence study participation differed by wave using chi-square analyses. Specifically, we examined whether race, age, gender, education level, health status, tobacco behaviors, COVID-19–related symptoms, reasons for participating in the study, and SARS-CoV-2 positivity rates differed by wave.

Results:
Respondents included 3658 individuals, including 1495 in wave 1 (40.9%), 1246 in wave 2 (34.1%), and 917 in wave 3 (25%), for an overall participation rate of 23.6%. No significant differences in any examined variables were observed across waves, suggesting similar characteristics among those needing additional reminders compared with early participants.

Conclusions:
Using established techniques, we found no evidence of nonresponse bias in a random sample with a relatively low response rate. A hypothetical additional wave of participants would be unlikely to change original study conclusions. Successive wave analysis is an effective and easy tool that can allow public health researchers to assess, and possibly adjust for, nonresponse in any epidemiological survey that uses reminders to encourage participation.