bluuebunny/crossref_metadata_2025 huggingface dataset:
Implementation of a data control framework to ensure confidentiality, integrity, and availability of high-quality real-world data (RWD) in the NeuroTransData (NTD) registry
Authors: Wehrle Knut , Tozzi Viola , Braune Stefan , Roßnagel Fabian , Dikow Heidi , Paddock Silvia , Bergmann Arnfin , van Hövell Philip
Published: March 2022

Objective

To implement a dynamic data management and control framework that meets the multiple demands of high data quality, rigorous information technology security, and flexibility to continuously incorporate new methodology for a large disease registry.

Materials and Methods

Guided by relevant sections of the COBIT framework and ISO 27001 standard, we created a data control framework supporting high-quality real-world data (RWD) studies in multiple disease areas. We first mapped and described the entire data journey and identified potential risks for data loss or inconsistencies. Based on this map, we implemented a control framework adhering to best practices and tested its effectiveness through an analysis of random data samples. An internal strategy board was set up to regularly identify and implement potential improvements.

Results

We herein describe the implementation of a data management and control framework for multiple sclerosis, one disease area in the NeuroTransData (NTD) registry that exemplifies the dynamic needs for high-quality RWD analysis. Regular manual and automated analysis of random data samples at multiple checkpoints guided the development and implementation of the framework and continue to ensure timely identification of potential threats to data accuracy.

Discussion and conclusions

High-quality RWD, especially those derived from long-term disease registries, are of increasing importance from regulatory and reimbursement perspectives, requiring owners to provide data of comparable quality to clinical trials. The framework presented herein responds to the call for transparency in real-world analyses and allows doctors and patients to experience an immediate benefit of the collected data for individualized optimal care.
Combining frog-leg lateral view may serve as a more sensitive X-ray position in monitoring collapse in osteonecrosis of the femoral head
Authors: Wei Qiu-Shi , He Min-Cong , He Xiao-Ming , Lin Tian-Ye , Yang Peng , Chen Zhen-Qiu , Zhang Qing-Wen , He Wei
Published: March 2022

Load-bearing capacity of the bone structures of anterolateral weight-bearing area plays an important role in the progressive collapse in osteonecrosis of the femoral head (ONFH). The purpose of this study is to assess the efficacy of combined evaluation of anteroposterior (AP) and frog-leg lateral (FLL) view in diagnosing collapse. Between December 2016 and August 2018, a total of 478 hips from 372 patients with ONFH (268 male, 104 female; mean age 37.9 ± 11.4 years) were retrospectively evaluated. All patients received standard AP and FLL views of hip joints. Japanese Investigation Committee (JIC) classification system was used to classify necrotic lesion in AP view. Anterior necrotic lesion was evaluated by FLL view. All patients with pre-collapse ONFH underwent non-operative hip-preserving therapy. The collapse rates were calculated and compared with Kaplan–Meier survival analysis with radiological collapse as endpoints. Forty-four (44/478, 9.2%) hips were classified as type A, 65 (65/478, 13.6%) as type B, 232 (232/478, 48.5%) as type C1 and 137 (137/478, 28.7%) as type C2. Three hundred cases (300/478, 62.5%) were collapsed at the initial time point. Two hundred and twenty six (226/300, 75.3%) hips and 298 (298/300, 99.3%) hips collapse were identified with AP view and FLL view, respectively. An average follow-up of 37.0 ± 32.0 months was conducted to evaluate the occurrence of collapse in 178 pre-collapse hips. Collapses occurred in 89 hips (50.0%). Seventy-seven (77/89, 86.5%) hips were determined with AP view alone and 85 (85/89, 95.5%) hips were determined with the combination of AP and FLL views. The collapse rates at five years were reported as 0% and 0%, 16.2% and 24.3%, 58.3% and 68.1% and 100% and 100% according to AP view alone or combination of AP and FLL views for types A, B, C1 and C2, respectively. The collapse can be diagnosed more accurately by combination of AP and FLL views. Besides, JIC type A and type B ONFH can be treated with conservative hip preservation, but pre-collapse type C2 ONFH should be treated with joint-preserving surgery. Type C1 needs further study to determine which subtype has potential risk of collapse.
Bringing PROMIS to Early Childhood: Introduction and Qualitative Methods for the Development of Early Childhood Parent Report Instruments
Authors: Cella David , Blackwell Courtney K , Wakschlag Lauren S
Published: March 2022

Objective

Provide an overview of the Patient-Reported Outcomes Measurement Information System (PROMIS®) Early Childhood Parent Report measurement development project and describe its qualitative methods.

Methods

The PROMIS Early Childhood (PROMIS EC) initiative used the PROMIS mixed-methods approach to patient-reported outcome development, with insight from the developmental specification framework to create parent report measures appropriate for assessing young children’s health-related quality of life. Qualitative methods to develop these instruments included expert input, literature and measure review, and parent concept elicitation and cognitive interviews to confirm the measure frameworks, item understandability, and developmental appropriateness.

Results

Twelve measures resulted from the PROMIS EC initiative. These parent report instruments cover young children’s physical, mental, and social health.

Conclusions

The new PROMIS EC Parent Report instruments offer clinicians and researchers brief and psychometrically robust tools to evaluate young children’s physical, mental, and social health outcomes. Aligned with the PROMIS Pediatric instruments, the early childhood versions enable coherent lifespan measurement starting at age 1 while maintaining developmental sensitivity.
Measuring PROMIS® Physical Activity and Sleep Problems in Early Childhood
Authors: Lai Jin-Shei , Blackwell Courtney K , Tucker Carole A , Jensen Sally E , Cella David
Published: March 2022

Objective

Physical activity (PA) and sleep are leading health indicators for individuals of all ages. Monitoring young children’s PA and sleep using psychometrically sound instruments could help facilitate timely interventions to promote healthy development. This article describes the development of the PROMIS® Early Childhood (EC) Parent Report Physical Activity (PA) and Sleep Problems (SP) measures for children aged 1–5 years.

Methods

Item pools were generated by interviewing parents, input from content experts, and literature review. Data from a U.S. general population sample were used to determine factor structures of item pools via factor analytic approaches, estimate item parameters via item response theory (IRT) models, and establish norms. Pearson correlations were used to evaluate across-domain associations. Analysis of variance was used and known-groups’ validity of PA and SP by comparing their scores to PROMIS EC Parent Report Global Health: child’s physical, emotional, and mental conditions.

Results

Initial item pools consisted of 19 and 26 items for PA and SP, respectively. Factor analyses’ results supported unidimensionality of 5 and 16 items measuring PA and SP, respectively, which were then calibrated using IRT. Norms were established by centering to a probability-based U.S. general population. Computerized adaptive testing algorithms were established. Some analyses supported initial measure validity.

Conclusions

The PROMIS EC PA calibrated scale and SP item banks are user-friendly and brief, yet produce precise scores. Both measures enable psychometrically sound assessment of PA behavior and sleep problems. Future studies to comprehensively evaluate the validity of these two measures are warranted.
Measuring PROMIS® Well-Being in Early Childhood
Authors: Blackwell Courtney K , Kallen Michael A , Lai Jin-Shei , Bevans Katherine B , Wakschlag Lauren S , Cella David
Published: March 2022

Objective

Expand the current Patient-Reported Outcome Measurement Information System (PROMIS®) well-being measures to early childhood (1–5 years) using best practices from PROMIS and developmental science.

Methods

Qualitative methods included expert input, literature and measure review, and parent interviews to confirm measure frameworks, item understandability, and developmental appropriateness. Quantitative methods included two waves of field testing and item response theory (IRT)-based psychometric evaluation of reliability and validity, as well as IRT centering and item calibration. Correlational analyses with other PROMIS Early Childhood (EC) Parent Report measures and known-group differences analyses by health status were conducted to evaluate construct validity. All measures were normed to the general U.S. population.

Results

Qualitative results suggested three primary early childhood well-being domains: Positive Affect, Engagement, and Self-Regulation. Quantitative results revealed a unidimensional factor structure for Positive Affect and multidimensional factor structures for Engagement and Self-Regulation, both of which had two factors accounting for >10% of modeled variance reflecting unique unidimensional domains. This resulted in five final PROMIS EC well-being measures: Positive Affect, Engagement—Curiosity, Engagement—Persistence, Self-Regulation—Flexibility, and Self-Regulation—Frustration Tolerance. Correlations and known-groups differences analyses showed robust construct validity across a range of chronic health conditions.

Conclusions

The new PROMIS EC Parent Report well-being measures offer clinicians and researchers a brief, efficient, and precise way to evaluate young children’s well-being. All five measures include only positively valanced item content, which pushes the field to evaluate the presence of children’s positive assets rather than the absence of problems.
The effective reproductive number of the Omicron variant of SARS-CoV-2 is several times relative to Delta
Authors: Liu Ying , Rocklöv Joacim
Published: March 2022

Our review found the effective reproduction number and basic reproduction number of the Omicron variant elicited 3.8 and 2.5 times higher transmissibility than the Delta variant, respectively. The Omicron variant has an average basic and effective reproduction number of 8.2 and 3.6.
Towards improved dynamic photosynthesis in C3 crops by utilizing natural genetic variation
Authors: Sakoda Kazuma , Adachi Shunsuke , Yamori Wataru , Tanaka Yu
Published: March 2022

Under field environments, fluctuating light conditions induce dynamic photosynthesis, which affects carbon gain by crop plants. Elucidating the natural genetic variations among untapped germplasm resources and their underlying mechanisms can provide an effective strategy to improve dynamic photosynthesis and, ultimately, improve crop yields through molecular breeding approaches. In this review, we first overview two processes affecting dynamic photosynthesis, namely (i) biochemical processes associated with CO2 fixation and photoprotection and (ii) gas diffusion processes from the atmosphere to the chloroplast stroma. Next, we review the intra- and interspecific variations in dynamic photosynthesis in relation to each of these two processes. It is suggested that plant adaptations to different hydrological environments underlie natural genetic variation explained by gas diffusion through stomata. This emphasizes the importance of the coordination of photosynthetic and stomatal dynamics to optimize the balance between carbon gain and water use efficiency under field environments. Finally, we discuss future challenges in improving dynamic photosynthesis by utilizing natural genetic variation. The forward genetic approach supported by high-throughput phenotyping should be introduced to evaluate the effects of genetic and environmental factors and their interactions on the natural variation in dynamic photosynthesis.
The cosmic web connection to the dark matter halo distribution through gravity
Authors: Kitaura F-S , Balaguera-Antolínez A , Sinigaglia F , Pellejero-Ibáñez M
Published: March 2022

This work investigates the connection between the cosmic web and the halo distribution through the gravitational potential at the field level. We combine three fields of research, cosmic web classification, perturbation theory expansions of the halo bias, and halo (galaxy) mock catalogue making methods. In particular, we use the invariants of the tidal field and the velocity shear tensor as generating functions to reproduce the halo number counts of a reference catalogue from full gravity calculations, populating the dark matter field on a mesh well into the non-linear regime ($3\, h^{-1}\, {\rm Mpc}$ scales). Our results show an unprecedented agreement with the reference power spectrum within 1 per cent up to $k=0.72\, h\, {\rm Mpc}^{-1}$. By analysing the three-point statistics on large scales (configurations of up to $k=0.2\, h\, {\rm Mpc}^{-1}$), we find evidence for non-local bias at the 4.8σ confidence level, being compatible with the reference catalogue. In particular, we find that a detailed description of tidal anisotropic clustering on large scales is crucial to achieve this accuracy at the field level. These findings can be particularly important for the analysis of the next generation of galaxy surveys in mock galaxy production.
Ravel’s Octatonic Scripts
Authors: Blättler Damian
Published: March 2022

This article investigates the use of octatonic chord progressions at deeper structural levels in the music of Maurice Ravel. Octatonic chord progressions are successions of triads and seventh chords derived from a single octatonic collection that are incompatible with other scales. These are shown to form the foundation for large spans of music, even when their constituent chords are embellished with non-octatonic macroharmony; the Discrete Fourier Transform is used to distinguish between the octatonicity of an underlying progression and the various surface colors that adorn it. Deeper-level octatonic chord progressions are woven into the formal scripts of several of Ravel’s major compositions: the two piano concerti, the Violin Sonata, and the Rapsodie espagnole. In these pieces, long-range motion through octatonic progressions undergirds entire sections or movements, and interacts with other elements of the work to create dynamic formal processes.
Asymmetric information, strategic transfers, and the design of long-term care policies
Authors: Canta Chiara , Cremer Helmuth
Published: March 2022

We study the optimal design of social long-term care (LTC) insurance when the utility of informal caregivers is taken into account. Informal care is exchange-based. Children’s cost of providing care is continuously distributed over some interval and is not observable. Parents choose a rule specifying transfers conditional on the level of informal care. We study first uniform provision of LTC and then a nonlinear policy depending on family transfers. In both cases, informal care increases with the children’s welfare weight. Our theoretical analysis is completed by calibrated numerical solutions. Uniform public care should represent up to 40% of total care but its share decreases to about 30% as the weight of children increases. In the nonlinear case, public care increases with the children’s cost of providing care at a faster rate when children’s weight in social welfare is higher. It represents 100% of total care for families with high-cost children.
Detection of HIV Virologic Failure and Switch to Second-Line Therapy: A Systematic Review and Meta-analysis of Data From Sub-Saharan Africa
Authors: Bernabé Kerlly J , Siedner Mark , Tsai Alexander C , Marconi Vincent C , Murphy Richard A
Published: March 2022

Background

The late recognition of virologic failure (VF) places persons with HIV in Sub-Saharan Africa at risk for HIV transmission, disease progression, and death. We conducted a systematic review and meta-analysis to determine if the recognition and response to VF in the region has improved.

Methods

We searched for studies reporting CD4 count at confirmed VF or at switch to second-line antiretroviral therapy (ART). Using a random-effects metaregression model, we analyzed temporal trends in CD4 count at VF—or at second-line ART switch—over time. We also explored temporal trends in delay between VF and switch to second-line ART.

Results

We identified 26 studies enrolling patients with VF and 10 enrolling patients at second-line ART switch. For studies that enrolled patients at VF, pooled mean CD4 cell count at failure was 187 cells/mm3 (95% CI, 111 to 263). There was no significant change in CD4 count at confirmed failure over time (+4 cells/year; 95% CI, –7 to 15). Among studies that enrolled patients at second-line switch, the pooled mean CD4 count was 108 cells/mm3 (95% CI, 63 to 154). CD4 count at switch increased slightly over time (+10 CD4 cells/year; 95% CI, 2 to 19). During the same period, the mean delay between confirmation of VF and switch was 530 days, with no significant decline over time (–14 days/year; 95% CI, –58 to 52).

Conclusions

VF in Africa remains an event recognized late in HIV infection, a problem compounded by ongoing delays between VF and second-line switch.
Excellent Traits in Public Health: Virtuous Structures and the Structure of Virtue
Authors: Meagher Karen M
Published: March 2022

MacKay’s Public Health Virtue Ethics offers a distinctive approach to public health ethics, with social structures at the forefront. MacKay’s helpful overview of the recent literature considers three distinct referents for ascribing virtues in public health ethics: (i) individuals, such as public health practitioners, (ii) social structures, such as public health institutions and policies and (iii) the communities affected by public health policy. While MacKay is interested in virtuous structures, I am interested in the structure of virtue as a precursor to this approach. In this commentary, I seek to unpack the structure of virtue itself, to delineate what various accounts of public health virtues offer, including MacKay’s new account. For such clarity, I turn to David Pears’ neo-Aristotelian essay on moral courage, in which he distinguishes external goals, internal goals and countergoals. Additional virtue vocabulary advances discussion of how the moral psychology of virtue traditions can be best adapted to public health professions, policy and practice.
Development and carotenoid synthesis in dark-grown carrot taproots require PHYTOCHROME RAPIDLY REGULATED1
Authors: Arias Daniela , Ortega Angélica , González-Calquin Christian , Quiroz Luis Felipe , Moreno-Romero Jordi , Martínez-García Jaime F , Stange Claudia
Published: March 2022

Light stimulates carotenoid synthesis in plants during photomorphogenesis through the expression of PHYTOENE SYNTHASE (PSY), a key gene in carotenoid biosynthesis. The orange carrot (Daucus carota) synthesizes and accumulates high amounts of carotenoids in the taproot that grows underground. Contrary to other organs, light impairs carrot taproot development and represses the expression of carotenogenic genes, such as DcPSY1 and DcPSY2, reducing carotenoid accumulation. By means of RNA sequencing, in a previous analysis, we observed that carrot PHYTOCHROME RAPIDLY REGULATED1 (DcPAR1) is more highly expressed in the underground grown taproot compared with those grown in light. PAR1 is a transcriptional cofactor with a negative role in shade avoidance syndrome regulation in Arabidopsis (Arabidopsis thaliana) through the dimerization with PHYTOCHROME-INTERACTING FACTORs (PIFs), allowing a moderate synthesis of carotenoids. Here, we show that overexpressing AtPAR1 in carrot increases carotenoid production in taproots grown underground as well as DcPSY1 expression. The high expression of AtPAR1 and DcPAR1 led us to hypothesize a functional role of DcPAR1 that was verified through in vivo binding to AtPIF7 and overexpression in Arabidopsis, where AtPSY expression and carotenoid accumulation increased together with a photomorphogenic phenotype. Finally, DcPAR1 antisense carrot lines presented a dramatic decrease in carotenoid levels and in relative expression of key carotenogenic genes as well as impaired taproot development. These results suggest that DcPAR1 is a key factor for secondary root development and carotenoid synthesis in carrot taproot grown underground.
Efficacy and safety of obinutuzumab in systemic lupus erythematosus patients with secondary non-response to rituximab
Authors: Arnold Jack , Dass Shouvik , Twigg Sarah , Jones Colin H , Rhodes Ben , Hewins Peter , Chakravorty Mithun , Courtney Phil , Ehrenstein Michael , Md Yusof Md Yuzaiful , Vital Edward M
Published: March 2022

Objectives

Secondary inefficacy with infusion reactions and anti-drug antibodies (secondary non-depletion nonresponse, 2NDNR) occurs in 14% of SLE patients receiving repeated rituximab courses. We evaluated baseline clinical characteristics, efficacy and safety of obinutuzumab, a next-generation humanized type-2 anti-CD20 antibody licensed for haematological malignancies in SLE patients with 2NDNR to rituximab.

Methods

We collated data from SLE patients receiving obinutuzumab for secondary non-response to rituximab in BILAG centres. Disease activity was assessed using BILAG-2004, SLEDAI-2K and serology before, and 6 months after, obinutuzumab 2× 1000 mg infusions alongside methylprednisolone 100 mg.

Results

All nine patients included in the study received obinutuzumab with concomitant oral immunosuppression. At 6 months post-obinutuzumab, there were significant reductions in median SLEDAI-2K from 12 to 6 (P = 0.014) and total BILAG-2004 score from 21 to 2 (P = 0.009). Complement C3 and dsDNA titres improved significantly (both P = 0.04). Numerical, but not statistically significant improvements were seen in C4 levels. Of 8/9 patients receiving concomitant oral prednisolone at baseline (all >10 mg/day), 5/8 had their dose reduced at 6 months. Four of nine patients were on 5 mg/day and were in Lupus Low Disease Activity State following obinutuzumab. After obinutuzumab, 6/9 patients with peripheral B cell data achieved complete depletion, including 4/4 assessed with highly sensitive assays. Of the nine patients, one obinutuzumab non-responder required CYC therapy. One unvaccinated patient died from COVID-19.

Conclusions

Obinutuzumab appears to be effective and steroid-sparing in renal and non-renal SLE patients with secondary non-response to rituximab. These patients have severe disease with few treatment options but given responsiveness to B cell depletion, switching to humanized type-2 anti-CD20 therapy is a logical approach.
Developmental responses and survival ofAnopheles stephensilarval stages at different salinity levels
Authors: Jude Justin , Gunathilaka Nayana , Udayanaga Lahiru , Fernando Deepika , Premarathne Prasad , Wickremasinghe Rajitha , Abeyewickreme Wimaladharma
Published: March 2022

Background

Anopheles stephensi is a newly invaded vector in Sri Lanka. It has been identified in coastal areas in the northern and eastern parts of the country and evidences the ability to breed in brackish water environments.

Methods

Laboratory investigations were conducted with batches of 100 first and third instar larvae exposed to a salinity gradient (0–40 ppt). Survival rates at 1 h, 24 h and until pupation were recorded for first and third instar larvae at different salinity levels. The experiment was repeated four times for both instars. Data were analysed using the general linear model and probit analysis.

Results

Significant variations in adult emergence were observed from both larval stages at different salinity levels (p<0.05). The highest pupation rates were observed at 2.5 ppt salinity. The survival rate of first instar larvae after 24 h of salinity exposure was >80% up to 12.5 ppt, while 100% mortality was observed for from the ≥25 ppt level of salinity. More than 90% of the third instar larvae pupated from salinity levels <15 ppt. The lowest survival rate was reported as 15.8±2.47% at 25 ppt.

Conclusions

This indicates a high potential of increasing density of A. stephensi in coastal ecosystems in lagoons and other saline water bodies. Hence it is high time to redesign vector control interventions for vector breeding in coastal ecosystems.
Surgical management of a calzone-like posttraumatic infolding of a 10-year-old LASIK flap
Authors: Elahi Sina , Mazharian Adrien , Gatinel Damien
Published: March 2022

Introduction:

The popularity of femtosecond laser–assisted in situ keratomileusis (LASIK) has increased, but flap-related complications such as trauma and possibility of displacement, even years after surgery with complications such as striae, diffuse lamellar keratitis, and epithelial ingrowth, may still be challenging.

Patient and Clinical Findings:

A 45-year-old woman was referred a week after trauma and flap displacement on a 10-year-long myopic LASIK correction. Corrected distance visual acuity was 20/30 (0, −2.25 at 35 degrees) due to epithelial ingrowth involving the visual axis. The external third of the flap was rolled inward (calzone-like), exposing the underlying edematous stroma associated with dense fibrosis at the level of the roll.

Diagnosis, Intervention and Outcomes:

Emergency flap surgical revision was performed using a technique of mechanical debridement and a 20% alcohol-dipped sponge application to help with epithelial cells lysis, and fibrin glue was applied on the flap. Uncorrected distance visual acuity was restored and examination revealed a stable, well-apposed flap, without epithelial cell ingrowth, and an otherwise unremarkable examination.

Conclusions:

This study showed the 10-month-efficacy of a combined approach of mechanical debridement, ethanol-based cell lysis, and fibrin glue in traumatic 10-year-old-flap management with infolding or invagination and extensive epithelial ingrowth.
Macular phototoxicity after corneal crosslinking
Authors: Alfayyadh Mohammed A. , AlAbdulhadi Halla A. , Ahad Muhammad A.
Published: March 2022

Introduction:

Keratoconus is a progressive degenerative corneal disease of variable severity. Its management includes medical and surgical treatment. Corneal crosslinking (CXL) is being increasingly used to stabilize the condition. Macular phototoxicity is a well-known side effect of light exposure; however, its incidence after treatment with riboflavin and UV light is unknown. This study reported the clinical features of a patient with macular phototoxicity after UV-A exposure and described the structural and angiographic retinal changes observed in the patient.

Patient, Clinical Findings, and Diagnosis:

A 37-year-old man with keratoconus underwent corneal refractive surgery (topography-guided custom ablation with accelerated and high-fluence CXL). Postoperatively, he had decreased vision in the operated eye. Ophthalmoscopy, spectral-domain optical coherence tomography, and fluorescein angiography revealed retinal pigment epithelial changes, ellipsoid zone disruption, and window defects, respectively. The patient was diagnosed with macular phototoxicity. The corrected distance visual acuity stabilized at 20/100 after 6 months.

Conclusions:

Macular phototoxicity may occur after UV-A exposure during CXL. The use of accelerated and high-fluence protocols might have contributed to its occurrence in this patient.
Hydration Interventions Among Agricultural Workers
Authors: Chicas Roxana , Suarez Jonathan , Elon Lisa , Xiuhtecutli Nezahualcoyotl , House Madelyn C. , Berra Liris , Sands Jeff M. , Hertzberg Vicki , McCauley Linda
Published: March 2022

Objective:

To estimate the impact of hydration interventions on postworkday hydration status and incidence of acute kidney injury (AKI).

Methods:

Thirty agricultural workers were first monitored on a workday without any interventions. On the intervention workday, the same workers were randomized to one of two groups: 169 ounces (oz) (5 L) of plain water (n = 16) or 169 oz (5L) of water with electrolytes (n = 14).

Results:

No participants in the electrolyte group had an estimate glomerular filtration rate (eGFR) at the end of the workday of less than 90 mL/min/1.73 m2 or met the criteria for AKI in comparison to the water group (eGFR < 90: 15%; AKI: 23%) or the control group (eGFR < 90: 28%; AKI: 18%).

Conclusion:

The study showed that drinking water with electrolytes may lower the risk for development of AKI among agricultural workers.
Impact of Residual Limb Volume Loss on Socket Internal Pressures: A Preliminary Study
Authors: Sirrs Díaz Nora Emilia , Galván-Duque Carlos , Zavaleta José Luis , Letechipia Moreno Jorge
Published: March 2022

Introduction

Daily volume loss of residual limb is a condition that most prosthetic users face, negatively affecting their life. One of the consequences is the loss of contact between the residual limb and the socket, which modifies internal pressures.

Objective

The aim of this study was to study how the loss of volume of the residual limb affects socket adjustment through measuring pressures inside the socket.

Study design

The study design is prospective longitudinal.

Materials and Methods

Four subjects with unilateral transtibial amputation, with at least 1 year of prosthetic use, and walking with a comfortable prosthesis participated in this study. The pressure between the socket and the subject's residual limb was measured with an FSocket System (Tekscan). Residual limb volume was measured before and after each test with two different methods: optical scanning (Structure Sensor, Occipital) and conical frustum model. Sanders' protocol for volume loss was followed (Sanders et al. J Rehabil Res Dev. 2012;49:1467–1478). Volume changes in the residual limb and socket internal pressures were analyzed.

Results/Discussion

The pressure graph obtained is consistent with Sanders' volume graphs. The pressure distribution inside the socket is lost after 5 hours of use of the prosthetic device; this can be related to volume loss and alignment. The only area where the pressure increases is in the distal zone, given that once the prosthetic fit is lost, weight bearing is transferred to the socket's distal section (mean volume loss, intrasession −3%; mean pressure loss, intrasession −39%).

Conclusions

The study suggests that a small change in the volume can cause a change in the distribution of pressures inside the socket, indicating that the prosthetic fit may be compromised. For patient follow-up, measuring pressure inside the socket could be a useful indicator of socket misfit.

Clinical Relevance

Daily volume changes in the prosthesis can produce pressures that lead to pain, injuries, an inefficient gait, and prosthesis abandonment. Consequently, it is important to understand the behavior of the pressures inside the socket and the influence of the daily changes of volume on the socket adjustment to design better strategies and techniques of daily volume changes management.
Enlarged Vestibular Aqueduct: Disease Characterization and Exploration of Potential Prognostic Factors for Cochlear Implantation
Authors: Saeed Haroon S. , Rajai Azita , Nash Robert , Saeed Shakeel R. , Stivaros Stavros M. , Black Graeme , Bruce Iain A.
Published: March 2022

Objectives:

There is an unmet need to match the anticipated natural history of hearing loss (HL) in enlarged vestibular aqueduct (EVA) with clinical management strategies. The objectives of this study are therefore to provide a detailed case characterization of an EVA cohort and explore the relationship between candidate prognostic factors and timing of cochlear implant (CI) surgery.

Study Design:

A multicenter retrospective review of patients diagnosed with EVA.

Setting:

Patient data recruitment across three CI centers in the UK.

Patients:

One hundred fifty patients with a radiological diagnosis of EVA from January 1995 to January 2021.

Main Outcome Measures:

Age at audiological candidacy for CI and age at first implant surgery.

Results:

EVA was predominately a bilateral condition (144/ 150) with increased prevalence in women (M:F, 64:86). 51.7% of patients failed new-born hearing screening, with 65.7% having HL diagnosed by 1 year. Initial moderate to severe and severe to profound HL were reported most frequently. In 123 patients, median age that audiological candidacy for CI was met for at least one ear was 2.75 years. Median age at first CI was 5 years (140/150).

Pendred syndrome (confirmed in 73 patients) and ethnicity, were not significantly associated with earlier CI surgery. Multivariate linear regression demonstrated that male patients have first CI surgery significantly earlier than females (coefficient −0.43, 95% CI [−0.82, −0.05), p-value = 0.028).

Conclusions:

This large UK EVA cohort provides evidence that patients should be closely monitored for CI candidacy within the first 3 years of life. Significantly, male gender is emerging as an independent prognostic factor for earlier assessment and first CI surgery.
Accuracy of 2D BLADE Turbo Gradient- and Spin-Echo Diffusion Weighted Imaging for the Diagnosis of Primary Middle Ear Cholesteatoma
Authors: Lin Mengyan , Sha Yan , Sheng Yaru , Chen Wei
Published: March 2022

Objective

To evaluate the diagnostic accuracy of 2D BLADE turbo gradient- and spin-echo diffusion weighted imaging (TGSE BLADE DWI) for primary middle ear cholesteatoma diagnosis, using qualitative and quantitative methods.

Study Design

Retrospective case series.

Setting

University hospital.

Patients

Participants included those with suspected primary middle ear cholesteatoma after assessment by clinical otorhinolaryngologists combined with magnetic resonance imaging (MRI) examination. Finally, of the 85 ears from 65 patients enrolled in the study, 73 had cholesteatoma, and 12 had otitis media.

Intervention

Two radiologists independently assessed images and measured apparent diffusion coefficient (ADC) values. Sensitivity, specificity and accuracy were evaluated. Kappa (k) statistics, the intraclass correlation coefficient (ICC), the Kolmogorov–Smirnov normality test, the independent t test, and receiver operating characteristic (ROC) analysis were used for statistical analysis. Pair-wise comparison of the area under the ROC curve (AUC) was also performed using the Delong test.

Main Outcome Measures

Imaging and histopathologic findings.

Results

The mean ADC value of cholesteatoma group (mean, 0.923 ± 0.246 × 10–3 mm2/s) was significantly lower than that of noncholesteatoma group (mean, 1.744 ± 0.205 × 10–3 mm2/s; p < 0.001). In ≤3 mm cholesteatoma group, the AUC of qualitative DWI was 0.846; the sensitivity, specificity, and accuracy for diagnosing cholesteatoma were 69.23%, 100%, and 84%, respectively; while the AUC of quantitative diagnosis was significantly increased to 1.0 (p = 0.0209); and based on the optimal threshold of ADC, ≤1.352 × 10–3 mm2/s, the sensitivity, specificity and accuracy improved to 100%. For >3 mm cholesteatoma group, there were no significant differences in diagnostic performance. Excellent interobserver agreement and ICC for the qualitative and quantitative evaluations (k = 0.90 and ICC = 0.80, respectively) was noted between reviewers.

Conclusion

TGSE BLADE DWI is useful for the detection of primary middle ear cholesteatomas, especially ≤3 mm lesions.
A Healthcare Physician Can Be Trained to Perform Intestinal Ultrasound in Children With Inflammatory Bowel Disease
Authors: van Wassenaer Elsa A. , van Rijn Rick R. , de Voogd Floris A.E. , Noels Floor L. , Deurloo Eline E. , van Schuppen Joost , Verbeke Jonathan I.M.L. , Gecse Krisztina B. , D'Haens Geert R. , Benninga Marc A. , Koot Bart G.P. ,   RAINBOW‐group
Published: March 2022

Objectives:

Training healthcare physicians to perform intestinal ultrasound (IUS) during outpatient visits with equal accuracy as radiologists could improve clinical management of IBD patients. We aimed to assess whether a healthcare‐physician can be trained to perform IUS, with equal accuracy compared with experienced radiologists in children with iBD, and to assess inter‐observer agreement.

Methods:

Consecutive children, 6 to 18 years with IBD or suspicion of IBD, who underwent ileo‐colonoscopy were enrolled. iUS was performed independently by a trained healthcare‐physician and a radiologist in 1 visit. Training existed of an international training curriculum for IUS. Operators were blinded for each other's IUS, and for the ileocolonoscopy. Difference in accuracy of IUS by the healthcare‐physician and radiologist was assessed using areas under the ROC curve (AUROC). Inter‐observer variability was assessed in terminal ileum (TI), transverse colon (TC) and descending‐colon (DC), for disease activity (ie, bowel wall thickness [BWT] >2 mm with hyperaemia or fat‐proliferation, or BWT >3 mm).

Results:

We included 73 patients (median age 15, interquartile range [IQR]:13–17, 37 [51%] female, 43 [58%] with Crohn disease). AUROC ranged between 0.71 and 0.81 for the healthcare‐physician and between 0.67 and 0.79 for radiologist (P > 0.05). Inter‐observer agreement for disease activity per segment was moderate (K: 0.58 [SE: 0.09], 0.49 [SE: 0.12], 0.52 [SE: 0.11] respectively for TI, TC, and DC).

Conclusions:

A healthcare‐ physician can be trained to perform IUS in children with IBD with comparable diagnostic accuracy as experienced radiologists. The interobserver agreement is moderate. Our findings support the usage of IUS in clinical management of children with IBD.
Development of a Health Literacy Workshop
Authors: Ladd Dana L. , Everette Sharon S.
Published: March 2022

A consumer health librarian and nurse educators collaborated to conduct health literacy workshops to teach healthcare providers skills to reduce the health literacy burden of their patients. The workshop content included health literacy overview, patient literacy levels, teach-back, evaluation of patient educational materials, and finding consumer health information. Forty-eight healthcare providers registered, and 39 in total attended one of five workshops and represented eight healthcare disciplines. Feedback from the workshops was positive.
Ibalizumab shows in-vitro activity against group A and group B HIV-2 clinical isolates
Authors: Le Hingrat Quentin , Collin Gilles , Bachelard Antoine , Ghosn Jade , Chalal Solayah , Pacanowski Jérôme , Peytavin Gilles , Weinheimer Steven , Marsolais Christian , Damond Florence , Matheron Sophie , Charpentier Charlotte , Descamps Diane ,   and the ANRS CO5 HIV-2 cohort
Published: March 2022

Objective:

Treatment of multidrug-resistant HIV-2 is an emerging issue, because of the rapid selection of mutations at time of virological failure and the low number of antiretrovirals active on HIV-2. The aim of this study was to determine the susceptibility of HIV-2 primary isolates to ibalizumab, a long-acting monoclonal antibody that binds to CD4 that is approved for the treatment of MDR HIV-1.

Methods:

In-vitro phenotypic susceptibility of 16 HIV-2 primary isolates was measured using a modified version of the ANRS peripheral blood mononuclear cells (PBMC) assay. Susceptibility to ibalizumab was assessed through 50% inhibitory concentrations and maximum percentage inhibitions (MPI), and gp105 was sequenced to look for determinants of reduced susceptibility.

Results:

Ibalizumab inhibited viral replication of all 16 isolates, with a median IC50 value of 0.027 μg/ml (range = 0.001–0.506 μg/ml), and a median MPI of 93%. Although two isolates presented higher IC50 (above 0.1 μg/ml), they did not exhibit a loss of potential N-linked glycosylation sites in V5 loop, as reported in HIV-1 strains with reduced susceptibility. However, both presented shorter V1 and V2 loops than the HIV-2 reference strain.

Conclusion:

Ibalizumab inhibits HIV-2 replication, with IC50 and MPI in the range of those reported for HIV-1. These in vitro data support the use of ibalizumab in patients with MDR HIV-2, in combination with an optimized background regimen.
A Two-Stage Training Program for Auricular Framework Fabrication Practicing Using Three-Dimensional Printing Silicone Ribs and Porcine Costal Cartilage
Authors: Tao Ran , Dong Weiwei , Sun Pengfei , Xue Chunyu , Pan Bo
Published: March 2022

Background:

The manufacture of cartilage framework is a key element in the success of total ear reconstruction. Appropriate training can improve cartilage curving and fabricating skills, which is especially helpful for the novice clinicians. Based on threedimensional printing silicone model and porcine rib cartilage, the authors have designed a 2-stage training program to improve skills and cosmetic cognition for ear reconstruction.

Methods:

The training program includes 2 successive stages. In the first stage, trainees completed observation of framework fabrication, design and sculpturing practice on silicone rib models. Porcine costal cartilages are used for fabrication in the second stage. After that, the framework was put in a latex glove connected with a suction to simulate the skin cover procedure in operation.

Results:

At the end of the training program, all trainees could fabricate an ear-shaped cartilage framework successfully. Their cosmetic cognitions of the ear have also improved.

Conclusions:

Based on three-dimensional printing silicone model and porcine rib cartilage, the authors have designed a 2-stage training program to improve trainee’s carving techniques and cosmetic cognition for ear reconstruction. The authors believe that this training program is helpful in training, practicing and teaching activities of framework fabrication in total ear reconstruction.
The Efficiency of Different Arthroscopic Discopexy Techniques Based on Clinical and Radiographic Findings: A Systematic Review
Authors: Pliavga Vykintas , Šakalys Dovydas , Leketas Marijus
Published: March 2022

The aim of this systematic review was to evaluate the effectiveness of different temporomandibular joint arthroscopic discopexy techniques.

The systematic review was conducted according to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement and an electronic search was performed using MEDLINE (PubMed), The Cochrane Library, ScienceDirect databases using a combination of the terms ‘‘discopexy,’’ ‘‘disc recapture,’’ ‘‘disc fixation,’’ and ‘‘temporomandibular joint’’ to identify clinical trials published from 2010.

In total, 493 records were screened, of which only 9 fulfilled the inclusion criteria and were included in qualitative data synthesis.

The results of clinical findings evaluation showed that arthroscopic discopexy statistically significantly improved levels of pain (VAS) and maximum interincisal opening whereas magnetic resonance imaging evaluation showed disc position improvement of up to 90% to 100%.

In conclusion, this review provides the evidence of the potential benefits of arthroscopic disc fixation in the treatment of patients with internal derangements : reduced pain, increased maximum interincisal opening, and improved disc position evaluated by magnetic resonance imaging, whereas disc fixation using suturing techniques seems to be the most appropriate method.
Emergency department return visits and hospital admissions in trauma team assessed patients initially discharged from the emergency department: A population-based cohort study
Authors: Evans Christopher C.D. , Li Wenbin , Balari Pardis , Ma Jennifer , Brogly Susan B.
Published: March 2022

BACKGROUND

Many injured patients are transported directly to trauma centers, found to be minimally injured, and discharged directly home from the emergency department (ED). Our objectives were to characterize the short-term outcomes in this discharged patient population and to identify patient factors predictive of ED return visits.

METHODS

We conducted a retrospective population-based cohort study using linked administrative data sets involving patients assessed at trauma centers in Ontario, Canada between April 1, 2009, and March 31, 2020. Patients who were assessed by a trauma team and discharged directly home from ED were included. The primary outcome was the percentage of patients with an ED return visit within 14 days. We used multivariate logistic regression analyses to identify patient characteristics predictive of at least one ED return visit.

RESULTS

There were 5,550 patients included in the study. A total of 1,004 (18.1%) of patients had at least one ED return visit, but only 100 patients (1.8%) were admitted to hospital following initial discharge. Common reasons for ED return visits included wound care concerns (17.2%), head injury complaints (15.6%), and substance misuse (6.8%). Rural residence (odds ratio [OR], 1.83; 95% CI, 1.45–2.29), history of anxiety disorder (OR, 2.05; 95% CI, 1.54–2.73), high baseline ED usage (OR, 2.58; 95% CI, 2.03–3.28), penetrating injury (OR, 1.42; 95% CI, 1.20–1.68), and extremity fracture (OR, 1.52; 95% CI, 1.24–1.88) predicted return visits.

CONCLUSION

Patients discharged directly have high rates of ED return visits but low rates of hospital admission or delayed surgical intervention. Trauma services should expand quality assurance initiatives to capture return visits, understand any gaps in clinical service provision, and aim to minimize unnecessary ED return visits.

LEVEL OF EVIDENCE

Prognostic/Epidemiological; Level IV.
FFP maintains normal coagulation while Kcentra induces a hypercoagulable state in a porcine model of pulmonary contusion and hemorrhagic shock
Authors: Dixon Alexandra , Beiling Marissa , Smith Sawyer , Behrens Brandon , Appleman Luisa , Rick Elizabeth , Murphy James , Madtson Brianne , McCully Belinda , Goodman Andrew , Kanlerd Amonpon , Schaller Traci , Subramanian Sarayu , Trivedi Alpa , Pati Shibani , Schreiber Martin
Published: March 2022

BACKGROUND

Moderate injury can lead to a coagulopathy. Fresh frozen plasma (FFP) corrects coagulopathy by means of a balanced array of clotting factors. We sought to compare the late effects of FFP and a prothrombin complex concentrate (PCC) on the coagulopathy of trauma using a porcine model of pulmonary contusion (PC) and hemorrhagic shock (HS) designed to evaluate the organ protective effects of these treatments.

METHODS

Female Yorkshire swine (40–50 kg) were randomized to receive PC + HS or control (instrumented and uninjured). A blunt PC was created using a captive bolt gun. To induce HS, a liver crush injury was performed. Eighty minutes after injury, swine were treated with 25 U·kg−1 PCC, 1 U FFP, or 50 mL lactated Ringer’s vehicle in a blinded manner. Arterial blood samples were drawn every 6 hours. Swine were euthanized 48 hours postinjury. Data were analyzed by Pearson χ2, analysis of variance and Kruskal-Wallis tests with Tukey’s or Mann-Whitney U tests for post hoc analysis.

RESULTS

Twenty-seven swine received PC + HS, 3 groups of 9 per group received PCC, FFP, or vehicle. Nine were noninjured controls. When compared with control, PC + HS swine had significantly shortened R time at 6 hours, 36 hours, and 42 hours, decreased LY30 at 12 hours, shortened K time at 30 hours and reduced α angle at 42 hours. PC + HS swine showed significant differences between treatment groups in K and α angle at 3 hours, LY30 at 12 hours and 18 hours, and MA at 12 hours, 18 hours, and 30 hours. Post hoc analysis was significant for higher α angle in PCC versus vehicle at 3 hours, higher MA in vehicle versus PCC at 12 hours and 18 hours, and higher LY30 in PCC versus vehicle at 18 hours (p < 0.012) with no significant differences between FFP and vehicle.

CONCLUSION

Severe injury with HS induced a coagulopathy in swine. While FFP maintained normal coagulation following injury, PCC induced more rapid initial clot propagation in injured animals.