bluuebunny/crossref_metadata_2025 huggingface dataset:
Design and analysis of group-sequential clinical trials based on a modestly weighted log-rank test in anticipation of a delayed separation of survival curves: A practical guidance
Authors: Magirr Dominic , Jiménez José L
Published: March 2022

Background:

A common feature of many recent trials evaluating the effects of immunotherapy on survival is that non-proportional hazards can be anticipated at the design stage. This raises the possibility to use a statistical method tailored towards testing the purported long-term benefit, rather than applying the more standard log-rank test and/or Cox model. Many such proposals have been made in recent years, but there remains a lack of practical guidance on implementation, particularly in the context of group-sequential designs. In this article, we aim to fill this gap.

Methods:

We illustrate how the POPLAR trial, which compared immunotherapy versus chemotherapy in non-small-cell lung cancer, might have been re-designed to be more robust to the presence of a delayed effect using the modestly-weighted log-rank test in a group-sequential setting.

Conclusion:

We provide step-by-step instructions on how to analyse a hypothetical realization of the trial, based on this new design. Basic theory on weighted log-rank tests and group-sequential methods is covered, and an accompanying R package (including vignette) is provided.
Incorporating estimands into clinical trial statistical analysis plans
Authors: Kang Minhee , Kendall Michelle A , Ribaudo Heather , Tierney Camlin , Zheng Lu , Smeaton Laura , Lindsey Jane C
Published: March 2022

Background:

International Council for Harmonisation (ICH) E9 Statistical Principles for Clinical Trials was developed as a consensus guidance document to encourage worldwide harmonization of the principles of statistical methodology in clinical trials. Addendum E9 (R1) clarified and extended ICH E9 with a focus on estimands and sensitivity analyses. Since the release of E9 (R1), clinical trial protocols have included estimands, but there is variation in how they are presented. Statistical analysis plans (SAPs) are increasingly becoming publicly available (e.g. posting on ClinicalTrials.gov) and present an opportunity to link estimands with planned analyses to present the alignment of trial objectives, design, conduct, and analysis.

Methods:

A table format was used to create a template for inclusion in SAPs that satisfies ICH E9 (R1) guidance to align statistical analysis to the estimand. The template provides a consistent structure for presentation of estimands and the associated analysis, and is applicable to a wide range of trial designs. We illustrate use of the template with a hypothetical clinical trial in HIV-1.

Results:

The estimand-to-analysis table template starts with the study objective describing the clinical question of interest as written in the trial protocol. The remainder of the table describes each attribute of the estimand (treatment, target population, variable, intercurrent events, and population-level summary) in the left column (ESTIMAND), while the right column describes how each attribute will be handled using the data collected in the clinical trial (ANALYSIS). The template was applied to a hypothetical, early-phase single-arm trial, modeled after a pediatric trial in HIV, where the objective was to determine the safety of a new antiretroviral drug as part of a combination antiretroviral treatment regimen in the pediatric population. Three intercurrent events were illustrated in the table: death, premature treatment discontinuation before 24 weeks, and pregnancy. An estimand-to-analysis table from a grant application that addresses the primary objective of a placebo-controlled randomized trial is also presented to demonstrate an alternative usage.

Conclusion:

We found the template to be useful in study design, providing a snapshot of the objective, target population, potential intercurrent events, analysis plan, and considerations for missing data in one place and facilitating discussion among stakeholders. The proposed standardized presentation of estimand attributes and analysis considerations in SAPs will provide guidance to SAP authors and consistency across studies to facilitate reviews.
Random effect misspecification in stepped wedge designs
Authors: Voldal Emily C , Xia Fan , Kenny Avi , Heagerty Patrick J , Hughes James P
Published: March 2022

Stepped wedge cluster randomized trials are often analysed using linear mixed effects models that may include random effects for cluster, time and/or treatment. We investigate the impact of misspecification of the random effects structure of the model. Specifically, we considered two cases of misspecification of the random effects in a cross-sectional stepped wedge cluster randomized trials model – fit a linear mixed effects model with random time effects but the true model includes random treatment effects (case 1) or fit a linear mixed effects model with random treatment effect but the true model includes random time effects (case 2) – and derived the variance of the estimated treatment effect under misspecification. We defined two measures of the effect of misspecification: validity and efficiency. Validity is the ratio of the model-based variance of the treatment effect from the mis-specified model divided by the true variance of the treatment effect from the mis-specified model (based on a sandwich estimate of the variance). Efficiency is the ratio of the model-based variance of the treatment effect from the correctly specified model divided by the true variance of the treatment effect from the mis-specified model. We found that validity is less than 1.0 (anti-conservative) in almost all situations investigated with the exception of case 1 with two sequences, when validity could be greater than 1.0. Efficiency is less than 1 in all cases and depends on the intracluster correlation coefficient, the relative magnitude of the variance of the misclassified variance component, and the number of sequences. In general, there is no universal recommendation as to the most robust approach except for the case of a classic stepped wedge cluster randomized trial with only 2 sequences, where fitting a random time model is less likely to lead to anti-conservative inference compared with fitting a random intervention model.
The effect of metabolic syndrome and/or hyperglycemia on outcomes of acute ischemic stroke patients treated with intravenous thrombolysis
Authors: Duan Zuowei , Wei Xiu’e , Liu Haiyan , Zhai Yujia , Hu Ting , Xu Jiang , Liu Tengfei , Yang Ming , Rong Liangqun
Published: March 2022

Backgrounds and Objectives:

The impact of metabolic syndrome (MetS)/hyperglycemia on the clinical outcomes of ischemic stroke treated with intravenous thrombolysis (IVT) remains controversial. This study aimed to determine the risks conferred by MetS and hyperglycemia to clinical outcomes in acute ischemic stroke patients treated with IVT.

Method:

Three hundred forty-three ischemic stroke patients treated with IVT were prospective recruited and stratified into four groups: neither, MetS only, hyperglycemia only, or both. The primary outcome was the 3-month poor functional outcome (PFO) which was defined as a 3-month modified Rankin Score (mRS) score ≧3. The secondary outcome included the hemorrhagic transformation (HT) and symptomatic intracranial hemorrhage (sICH) after IVT.

Results:

MetS was recognized in 197 (57.43%) patients. During the first 24 h after IVT, 44 (12.83%) patients had HT, of which 17 had sICH. Three-month PFO was found in 98 (28.57%) patients. After adjustment for potential confounders, MetS (odds ratio (OR) = 3.140, 95% confidence interval (CI) = 1.724–5.718) was independently associated with PFO. However, neither MetS nor its components were associated with 24-h HT or sICH. In the further subgroup analysis, we used the “neither” group as reference and found that the presence of both MetS and hyperglycemia (OR = 3.192, 95% CI = 1.338–7.615) and the presence of hyperglycemia only (OR = 2.097, 95% CI = 1.052–4.179) were significantly related to the 3-month PFO.

Conclusion:

MetS is an independent risk factor on 3-month PFO in acute ischemic stroke patients treated with IVT. Compared with “neither,” hyperglycemia only or concurrent with MetS was associated with an elevated risk of PFO after receiving IVT.
Vedolizumab has longer persistence than infliximab as a first-line biological agent but not as a second-line biological agent in moderate-to-severe ulcerative colitis: real-world registry data from the Persistence Australian National IBD Cohort (PANIC) study
Authors: Pudipeddi Aviv , Ko Yanna , Paramsothy Sudarshan , Leong Rupert W.
Published: March 2022

Background:

The choice between infliximab (IFX) and vedolizumab (VED) as a first-line biological agent in moderate-to-severe ulcerative colitis (UC) can be difficult. Second-line vedolizumab (VED) efficacy may decline following prior infliximab (IFX) treatment failure in UC patients. However, it is not known whether second-line IFX efficacy declines after failure of first-line VED.

Aims:

We aimed to compare first-line and second-line persistence of IFX and VED, in particular whether second-line IFX persistence declines after failure of first-line VED.

Methods:

Persistence of IFX and VED was analysed from the Australian Pharmaceutical Benefits Scheme registry data as either first- or second-line treatment in UC. Propensity score matching (1:1) was conducted in the comparison of first-line treatments. Cox proportional hazard regression analysis was used to identify significant predictors and expressed as a hazard ratio (HR and 95% CI).

Results:

There were 420 subjects with moderate-to-severe UC who received either first-line IFX ( n = 251) or VED ( n = 169), with 774 patient-years of follow-up. First-line VED had significantly longer persistence than first-line IFX (>50.2 versus 22.2 months, p = 0.001). Fifty-three subjects failed first-line IFX and swapped to second-line VED (IFX→VED group). Twenty-two subjects failed first-line VED group and swapped to second-line IFX (VED→IFX group). First-line VED persistence was significantly longer than second-line VED (>50.2 versus 32.0 months, p = 0.03), but first-line IFX persistence was not statistically significantly different to second-line IFX (27.6 months versus  > 38.6 months, p = 0.30). Immunomodulator co-therapy was significantly associated with a lower risk of nonpersistence of first-line VED (HR: 0.55, 95% CI: 0.33–0.89, p = 0.02) and IFX (HR: 0.63,95%CI: 0.33–0.92, p = 0.02).

Conclusion:

VED had a significantly longer persistence than IFX as first-line biological agent but does not disadvantage second-line IFX use in moderate-to-severe UC. VED after IFX is associated with significantly poorer persistence. VED, therefore, should be considered as the first-line biological agent of choice in UC.
PQQ Supplementation and SARS-CoV-2 Spike Protein-Induced Heart Inflammation
Authors: Boretti Alberto
Published: March 2022

SARS-CoV-2 spike protein-induced heart inflammation may originate from either COVID-19 infection or the administration of COVID-19 mRNA vaccines. As pyrroloquinoline quinone (PQQ) is a scavenger of free radicals, redox cofactor, and antioxidant which supports cognitive and mitochondrial functions, supplementation with PQQ could have a positive effect to reduce heart inflammation after COVID-19 mRNA vaccines. However, there is no evidence yet for this opportunity in the literature. Cellular and animal model results are missing. Similarly, no clinical trials have been conducted. While it is recommended to measure the levels of the cardiac biomarkers before and after COVID-19 vaccination, no recommendation can be made about supplementation with PQQ, which, however, we note has no contraindication.
The critical intersection between child reintegration and community connectedness: An experience from Guatemala
Authors: Guillermo Vanessa , Santos de Ucles Sully , Bunkers Kelley
Published: March 2022

A 2019 census of residential care facilities in Guatemala found 3863 children in residential care and that 97% of these children had at least one living relative. The census clearly indicates that children in the facilities are not orphans and the possibility of reunification, if appropriate processes and services are in place to support the child and parent/caregiver before, during, and after reunification, is possible. We (the authors) played a key role in designing a case management process to support the reunification of children from residential care back into families with the end goal being successful reintegration. A series of wellbeing domains were designed to help understand and measure what successful reintegration would include within the case management system. Informed by a case review of 36 Guatemalan children supported to reintegrate into families, and interviews with social workers and psychologists engaged in the process, this article explores the role of the “community connectedness” wellbeing domain. We explore how community connectedness or lack thereof, can contribute to child and parent/caregiver wellbeing and successful reintegration—the different types of community connectedness and who/what was involved in establishing and fostering these connections. With growing interest in reintegration efforts globally, efforts to better understand the unique role that community connectedness has in overall family wellbeing is well timed. Whilst the topic has been explored in post conflict settings with children and youth previously engaged in armed conflict, experiences of reintegration from residential care facilities in non-emergency contexts is limited, including in Spanish speaking contexts.
Determinants of practice of birth preparedness and complication readiness among pregnant women in Sodo Zuria District, Southern Ethiopia: Content analysis using Poisson’s regression
Authors: Haile Dereje , Wolde Jegnaw , Yohannes Dereje
Published: March 2022

Objectives:

Every pregnancy can face risk. One of the World Health Organization recommendations for health promotion interventions for maternal and newborn health was to increase birth preparedness and complication readiness. The main objective of this recommendation was to increase the use of skilled care at birth and to increase the timely use of facility care for obstetric and newborn complications. However, to the best of our knowledge, there is a dearth of documented evidence on the magnitude of birth preparedness and complication readiness and factors associated with it in our study area. Thus, the aim of this study was to identify factors affecting the practice of birth preparedness and complication readiness.

Methods:

A community-based cross-sectional study was carried out from 15 February to 15 March 2020. A total of 698 pregnant women were randomly selected and interviewed using a pretested semi-structured questionnaire. A multivariate generalized linear regression with Poisson link was carried out to see the effect of each independent variable on the dependent variable.

Result:

Of the sampled 710 participants, 698 participated, which made a response rate of 98.3%. The mean score of practice of birth preparedness and complication readiness was 3.3 (standard deviation = 1.8). Mothers who used pre-pregnancy contraception methods (adjusted odds ratio = 1.22 (95% confidence interval = 1.09, 1.37)), used bare feet as a mode of transportation (adjusted odds ratio = 1.11 (95% confidence interval = 1.01, 1.21)), used more antenatal care content (adjusted odds ratio = 1.09 (95% confidence interval = 1.06, 1.13)), and whose husbands were educated at the primary level of education (adjusted odds ratio = 1.19 (95% confidence interval = 1.03, 1.37)) were predictors in multivariable general.

Conclusion:

The mean score and overall practice of birth preparedness and complication readiness were low. This study revealed a low level of birth preparedness and complication readiness. In order to improve access to lifesaving care for women and neonates, there is a pressing need for implementation of existing strategies to increase practice of birth preparedness and complication readiness.
Understanding consumer practices in response to high cost of living
Authors: Pothin Gaëlle , Bachouche Hajer , Camelis Christèle , Sabri Ouidade
Published: March 2022

The objective of this article is twofold: (1) to develop a better understanding of “high cost of living” by a clear definition of the concept and (2) to report on the different adaptive strategies developed by individuals in reaction. Relying on a triangulation of three data collections from Reunionese consumers (12 exploratory interviews, a netnography, and 14 interviews with photo-elicitation), this study shows that the perception of high cost of living is at the origin of a feeling of loss of power (i.e. disempowerment). To regain control over their consumption, consumers develop adaptive strategies to live with and/or fight against high cost of living. This regaining of power or re-empowerment occurs both at the individual and collective levels (community, collaborative, or societal).
First report of phaeohyphomycosis caused by Phialophora americana in a domestic cat from Argentina
Authors: Borrás Pablo , Messina Fernando , Abrantes Rubén , Iachini Ricardo , Minatel Leonardo , Santiso Gabriela
Published: March 2022

Case summary

A 10-year-old male neutered domestic shorthair cat from Quilmes (Province of Buenos Aires, Argentina) presented at the Infectious Diseases and Parasitology Unit with a hyperpigmented nodule of 5 cm diameter on the nasal plane with a small ulceration of more than 1 year’s evolution. A scaly and hyperpigmented alopecic lesion of 3 cm in diameter was found on the lower edge of the tail. The patient was under immunosuppressive therapy with corticosteroids for lymphoplasmacytic duodenitis. Samples of the lesion present on the nasal plane were taken under a surgical procedure. In the wet mount preparations, pigmented irregular hyphae were observed. They developed dark colonies when cultured on Sabouraud medium. On micromorphology, structures compatible with Phialophora species were identified. PCR and sequencing of ITS (ITS1-5.8S-ITS2) confirmed Phialophora americana as the etiologic agent. A therapeutic scheme that included a combination of itraconazole oral solution (1.5 mg/kg PO q12h) with terbinafine (30 mg/kg PO q24h) was indicated for a period of 10 months. The patient died of complications resulting from its underlying disease.

Relevance and novel information

As far as the authors are aware, this is the first study to report P americana as an etiologic agent of phaeohyphomycosis in cats. In this case study, the species was identified using molecular tests.
Workplace Incivility and Employees’ Personal Initiative: A Moderated Mediation Model of Emotional Exhaustion and Meaningful Work
Authors: Gui Wenjing , Bai Qiyu , Wang Lei
Published: March 2022

Workplace incivility has many negative effects, but its impact on personal initiative and related mechanisms are still unclear. Drawing from conservation of resource theory, we tested the relationship between workplace incivility, emotional exhaustion, meaningful work, and personal initiative. The results from three-wave lagged and multisource data ( N = 229) indicated that workplace incivility was negatively correlated with personal initiative, and this relationship was mediated by emotional exhaustion. In addition, meaningful work attenuated the relationship between workplace incivility and personal initiative. The findings reveal that workplace incivility hurts employees’ personal initiative in the organizational context by depleting individuals’ emotional resources, leading to emotional exhaustion, while meaningful work is a critical cognitive resource that can buffer this relationship. Implications for theory and practice are discussed.
Teachers of Special Education and Assistive Technology: Teachers’ Perceptions of Knowledge, Competencies and Professional Development
Authors: Alsolami Abdulaziz S.
Published: March 2022

The main aim of this study is to quantitatively investigate special education teachers’ use of Assistive Technology (AT) in special education through a questionnaire distributed to special education teachers in the Jeddah School District. In all, 64 questionnaires were included in data analysis, which found that teachers have a moderate level of AT knowledge and skills and a moderate knowledge of AT concepts and terms, and felt moderately confident about identifying a variety of AT devices. Moreover, 90% of respondents are strongly interested in receiving more training on AT, preferably through one-on-one individualized instruction and attendance at workshops or conferences. This study recommends AT training as having special importance in preparing a conducive educational environment for students with disabilities, for as the professional development of teachers’ competency has a significant influence on teaching students with disabilities, this would better enable teachers to integrate AT into the school curriculum.
Constructing Hakka Ethnic Identity Through Narrative Genealogy Writing
Authors: Chang Chen-Chi , Lin Yu-Hsun
Published: March 2022

Ethnic identity exists within multiple cultural societies and is beneficial for individuals of an ethnic minority to build eudaimonic well-being. For ethnic identity research concerning ethnic minorities, it is critical to understand the drivers and effects of ethnic identity on eudaimonic well-being. Drawing on the perspective of narrative identity development, this study aims to investigate whether narrative writing of genealogy and a life story would improve the ethnic identity for the individuals of the Hakka ethnic minority and consequently facilitate fostering in them eudaimonic well-being. A total of 128 Hakka participants with the experience of writing genealogy were recruited by purposive sampling. The findings support the proposition that minorities through narrative genealogy writing about their identity can lead them to identify with their family and ethnic group, and thereby foster in them a sense of eudaimonic well-being. The Hakka minority can construct their ethnic identity through narrative genealogy writing.
“We’re Away From Everything”: Understanding the Struggles Faced by Internationalized Schools in Non-Urban Contexts in China
Authors: Poole Adam , Liujinya Yang , Yue Shi
Published: March 2022

This paper reports on an emerging type of international school, which we refer to as the Chinese internationalized school. This school caters to Chinese citizens and aspires to offer a fusion of national and international curricula. The majority of internationalized schools in China are to be found in large metropolitan centers. Accordingly, the literature has focused on relatively affluent urban centers, such as Shanghai, Suzhou, and Beijing. However, in recent years, internationalized schools have started to emerge outside of metropolitan areas in what have been described as tier-3 and 4 cities, which could also be described as non-urban or rural contexts, due to their remote location and proximity from metropolitan centers. This study adds to the scholarship on internationalized schooling in China by focusing on the struggles that schools in a non-urban contexts are likely to face. Focusing on one school, our interviews with 16 teachers and the school’s principal revealed that the school’s remote location made recruiting students and teachers problematic. Moreover, the effects of COVID-19 compounded this issue, with many prospective students abandoning their plans to study abroad and instead choosing to study in a local school offering the Chinese national curriculum. As a result, the school was forced to recruit students who did not possess the necessary English language ability to access the content of the Cambridge curriculum. This created a washback effect, which impacted on students’ academic achievement, their motivation, and the teaching strategies employed by the teachers. The paper concludes by considering what implications the findings might have for teachers and school leaders in internationalized schools in non-urban contexts.
Let Us Now Praise Mountain Lions: Revisiting Edward Abbey in the Santa Monica Mountains
Authors: Cappelli Mary Louisa
Published: March 2022

More than 50 years have passed since Edward Abbey published Desert Solitaire—his persuasive tribute to the preservation of wilderness and wildlife, and over 30 years since he penned. In Praise of Mountain Lions: Original Praises (1984), Abbey predicted how hyper-urbanization and anthropogenic stressors would lead to habitat fragmentation and to an extinction vortex among mountain lion populations. In this essay, I engage in an interdisciplinary approach employing Edward Abbey’s esthetic theory, political ideologies, and polemic land ethic to examine the urgent plight of mountain lions struggling to survive today in the Santa Monica Mountains. It is my hope that the synthesis of Edward Abbey’s political admonitions will contribute to the emerging body of interdisciplinary environmental literary criticism and research to advocate for the protection of mountain lions in urbanized landscapes.
Teaching Entrepreneurship Education (EE) Online During Covid-19 Pandemic: Lessons learned from a Participatory Action Research (PAR) in a Malaysian Public University
Authors: Lee Kenny Cheah Soon
Published: March 2022

This article focuses on a Participatory Action Research (PAR) project that was carried out in a Malaysian Public University during three series of lockdowns during the Covid-19 pandemic. During that time, all higher education institutes in Malaysia were barred from conducting face-to-face lectures that resorted to fully online learning throughout two semesters during the academic session of 2020 to 2021. As an educator, I was primary concerned about their achievement in learning outcomes and knowledge transfer through online learning of the Entrepreneurship Education (EE) Course. Therefore, this PAR described my critical reflections on my students’ feedbacks from the analysis of my online video lessons, online student forums, and open-ended online surveys regarding their sentiments and perceptions on their learning experience. Ultimately, this PAR is to help me improve my teaching skills, to highlight gaps in the course content and suggest strategies of delivery in the future. As such, this article concludes by highlighting the mismatch between learning gaps, the extent the EE course learning outcomes address the students’ personal obstacles in entrepreneurship and my future strategies to mitigate the challenges of entrepreneurship education.
The Importance of Early Pericardiectomy in Mulibrey Nanism Syndrome, a Case Report
Authors: Cordova Sanchez Andres , Vasigh Mostafa , Carhart Robert
Published: March 2022

Mulibrey (Muscle-Liver-Brain-Eye) Nanism syndrome is an extremely rare genetic disorder with multiorgan involvement. Constrictive pericarditis and diastolic dysfunction are the most common causes of mortality. We present a case of a patient with Mulibrey nanism syndrome who underwent pericardiectomy at 12 years old and was able to live 44 years more with relatively stable and asymptomatic diastolic congestive heart failure (CHF). This case highlights the importance of early recognition and treatment of constrictive pericarditis in these patients.
Chronic lymphocytic leukemia and light chain proximal tubulopathy: A rare presentation of a common disease
Authors: Klomjit Nattawat , Zand Ladan , Grande Joseph P , Leung Nelson
Published: March 2022

Chronic lymphocytic leukemia (CLL) is the most common leukemia in developed countries. Kidney injuries related to CLL can occur via several mechanisms. Approximately 30%–40% of CLL patients with a kidney biopsy have monoclonal-protein related lesions. However, such lesions mostly involve glomeruli with only rare instances of tubule-interstitial disorders. There is only a single case report of a CLL patient who presented with crystalline light chain proximal tubulopathy (LCPT). Fanconi syndrome (FS) may provide clinical clues in these patients. We report a case of a CLL patient who presented with hypokalemia in the setting of advanced kidney failure in which serum monoclonal IgG kappa was detected. The patient demonstrated typical signs and symptoms of FS. The urinary retinol binding protein was also extremely elevated (638 times upper normal limit). A kidney biopsy revealed non-crystalline LCPT with CLL infiltration. FS in CLL is an extremely rare presentation, as only four cases had been previously reported. Of these, only a single case had crystalline LCPT. Our case is the first report of non-crystalline LCPT in a CLL patient. Obinutuzumab and Venetoclax were started to address the CLL, and an improvement in kidney function was noted thereafter.
Full-Thickness Massive Rotator Cuff Repair With a Dermal Allograft Using CuffMend Augmentation Technique
Authors: Dasari Suhas P. , Fortier Luc M. , Bodendorfer Blake M. , DeFroda Steven F. , Cole Brian J. , Verma Nikhil N.
Published: March 2022

Background:

Rotator cuff repair using graft augmentation for large-to-massive, full-thickness rotator cuff tears has been reported to have improved clinical outcomes relative to other therapeutic interventions. Although an effective and promising technique, graft augmentation can be technically challenging, particularly with deployment and positioning of the graft. CuffMend is a user-friendly rotator cuff augmentation technique that combines a decellularized dermal allograft with a novel graft deployment device, tendon anchor, and set of lateral knotless, tension-able anchors to allow for a reliable and stable implantation of the graft.

Indications:

Graft augmentation using CuffMend is indicated for tears with a high risk of retear or incomplete healing. This includes revision tears, poor-quality degenerative tissue, and massive full-thickness rotator cuff tears. Severe glenohumeral osteoarthritic change is the primary contraindication to this technique.

Technique Description:

The rotator cuff is reduced medially and secured using 3 anchors with sutures passed in a mattress configuration. Graft augmentation is then performed using the CuffMend graft spreader that facilitates placement and attachment of the graft onto the repaired tendon.

Results:

The patient is recovering as expected and started physical therapy 1 month postoperatively. He is able to perform light activities of daily living and reach the top of his head for daily self-care without pain. He will begin strengthening at 12 weeks postoperatively.

Discussion/Conclusion:

CuffMend is a new graft augmentation technique that uses a novel graft deployment device for consistent and precise deployment of a decellularized dermal allograft. This facilitates an expedited repair using the graft augmentation technique for optimal clinical and biomechanical outcomes in patients with rotator cuff tears with high risk of retear.
The Role of Enhanced Recovery After Surgery Protocols in Cleft and Craniofacial Surgery: Update From the American Society of Craniofacial Surgeons
Authors: Oh Albert K. , Yu Jack C. , Singh Davinder J.
Published: March 2022

Enhanced Recovery After Surgery, or ERAS, was described by Kehlet in the 1990s. At first these programs focus on addressing preoperative, intraoperative, and postoperative factors to improve surgical outcomes in cardiac and colorectal procedures. Over the ensueing decades, many other surgical specialties within orthopedic surgery, gynecology, and surgical oncology have adopted the ERAS concepts and developed ERAS protocols. The ERAS approach is evidence-based, data-driven, leveraging group experience, and group intelligence. Recognizing the lack of ERAS protocols in craniomaxillofacial surgery, efforts for their development begun in 2019, jointly between members of the American Society of Craniofacial Surgeons (ASCFS) and the American Society of Maxillofacial Surgeons (ASMS). To date, ERAS protocols for the following procedures have been developed and released during national meetings: repair of cleft lip, palatoplasty, secondary alveolarbone graft, orthognathic surgery, and fronto-orbital advancement. The ERAS protocols address 4 phases: pre-hospital, pre-operative, intra-operative, and post-operative. These are living documents in that there is a closed feedback loop with interative evaluation followed by modification. As technology improves and more data become available, better treatments should replace existing ones. These protocols are developed by craniofacial surgeons for craniofacial units to improve patient outcomes.
Abbreviated Ultrasonography Examination Protocols for COVID-19 Patients: A Streamlined Process to Reduce Staff Exposure
Authors: Luna Cibele , Estanga Indira , Patricia Castillo Rosa
Published: March 2022

Objective:

The primary goal of this article is to show that an abbreviated ultrasonography (US) examination protocols can decrease imaging time and staff exposure.

Materials and Methods:

This is a single-center institutional review board (IRB)-approved retrospective cohort study in which 39 patients, positive for 2019 coronavirus disease (COVID-19), underwent an abbreviated US examination protocol from April to May 2020. Radiologists, specializing in body imaging, created these protocols. Descriptive statistics were performed, including the mean duration of the abbreviated US protocols and the mean duration of the standard US protocols, as a control group.

Results:

The abbreviated US protocols resulted in a significant time reduction ( P < .05) compared with the regular protocol duration.

Conclusion:

As radiology services face this unprecedented pandemic, implementing reduced US protocols can result in safer practices decreasing staff exposure.
New developments in tuberculosis diagnosis and treatment
Authors: Gill Cara M. , Dolan Lorraine , Piggott Laura M. , McLaughlin Anne Marie
Published: March 2022

Tuberculosis (TB) is a major cause of morbidity and mortality worldwide. It is estimated that 25% of the world's population are infected withMycobacterium tuberculosis, with a 5–10% lifetime risk of progression into TB disease. Early recognition of TB disease and prompt detection of drug resistance are essential to halting its global burden. Culture, direct microscopy, biomolecular tests and whole genome sequencing are approved methods of diagnosis; however, their widespread use is often curtailed owing to costs, local resources, time constraints and operator efficiency. Methods of optimising these diagnostics, in addition to developing novel techniques, are under review. The selection of an appropriate drug regimen is dependent on the susceptibility pattern of the isolate detected. At present, there are 16 new drugs under evaluation for TB treatment in phase I or II clinical trials, with an additional 22 drugs in preclinical stages. Alongside the development of these new drugs, most of which are oral medications, new shorter regimes are under evaluation. The aim of these shorter regimens is to encourage patient adherence, and prevent relapse or the evolution of further drug resistance. Screening for TB infection, especially in vulnerable populations, provides an opportunity for intervention prior to progression towards infectious TB disease. New regimens are currently under evaluation to assess the efficacy of shorter durations of treatment in this population. In addition, there is extensive research into the use of post-exposure vaccinations in this cohort. Worldwide collaboration and sharing of expertise are essential to our ultimate aim of global eradication of TB disease.

Educational aims

Differentiate between TB infection and TB disease.

Understand the different methods of diagnosing TB disease and resistance.

Recognise the different drugs and regimens currently in use for TB disease.

Be able to discuss risk of TB disease in TB infection, and assist patients in making an informed decision on treatment for TB infection.
How COVID-19 interacts with interstitial lung disease
Authors: Myall Katherine J. , Martinovic Jennifer L. , West Alex
Published: March 2022

The global pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has had far-reaching impacts on patients with interstitial lung disease (ILD), from diagnosis to management. In addition, after infection, persistent parenchymal change is associated with ongoing symptoms and functional impairment even in patients without pre-existing lung disease. The challenge of investigating and treating these patients has often fallen to ILD physicians. This review therefore seeks to explore the relationship between COVID-19 and the interstitium, as well as the model of care for patients with pre-existing ILD and those patients with persistent disease following recovery from their initial infection.

Educational aims

To understand the impact of the COVID-19 pandemic on patients with existing interstitial lung disease.

To explore the development of interstitial lung disease after COVID-19 infection.
Calcitonin gene-related peptide receptor antagonist BIBN4096BS regulates synaptic transmission in the vestibular nucleus and improves vestibular function via PKC/ERK/CREB pathway in an experimental chronic migraine rat model
Authors: Tian Ruimin , Zhang Yun , Pan Qi , Wang Yunfeng , Wen Qianwen , Fan Xiaoping , Qin Guangcheng , Zhang Dunke , Chen Lixue , Zhang Yixin , Zhou Jiying
Published: March 2022

Background

Vestibular symptoms are frequently reported in patients with chronic migraine (CM). However, whether vestibular symptoms arise through overlapping neurobiology of migraine remains to be elucidated. The neuropeptide calcitonin gene-related peptide (CGRP) and CGRP1 receptor play important pathological roles in facilitating central sensitization in CM. Therefore, we aimed to investigate whether CGRP1 receptor contributes to vestibular dysfunction after CM by improving synaptic transmission in the vestibular nucleus (VN).

Methods

A CM rat model was established by recurrent intermittent administration of nitroglycerin (NTG). Migraine- and vestibular-related behaviors were assessed. CGRP1 receptor specific antagonist, BIBN4096BS, and protein kinase C (PKC) inhibitor chelerythrine chloride (CHE) were administered intracerebroventricularly. The expressions of CGRP and CGRP1 receptor components, calcitonin receptor-like receptor (CLR) and receptor activity modifying protein 1 (RAMP1) were evaluated by western blot, immunofluorescent staining and quantitative real-time polymerase chain reaction in the vestibular nucleus (VN). Synaptic associated proteins and synaptic morphological characteristics were explored by western blot, transmission electron microscope, and Golgi-cox staining. The expressions of PKC, phosphorylated extracellular signal regulated kinase (p-ERK), phosphorylated cAMP response element-binding protein at serine 133 site (p-CREB-S133) and c-Fos were detected using western blot or immunofluorescent staining.

Results

The expressions of CGRP, CLR and RAMP1 were significantly upregulated in CM rats. CLR and RAMP1 were expressed mainly in neurons. BIBN4096BS treatment and PKC inhibition alleviated mechanical allodynia, thermal hyperalgesia and vestibular dysfunction in CM rats. Additionally, BIBN4096BS treatment and PKC inhibition markedly inhibited the overexpression of synaptic associated proteins and restored the abnormal synaptic structure in VN after CM. Furthermore, BIBN4096BS treatment dysregulated the expression levels of PKC, p-ERK and p-CREB-S133, and attenuated neuronal activation in VN after CM.

Conclusions

The present study demonstrated that CGRP1 receptor inhibition improved vestibular function after CM by reversing the aberrant synaptic transmission via downregulating PKC/ERK/CREB signaling pathway. Therapeutic interventions by inhibiting CGRP/CGRP1 signaling may be a new target for the treatment of vestibular symptoms in CM.
Global analysis of switchgrass (Panicum virgatum L.) transcriptomes in response to interactive effects of drought and heat stresses
Authors: Hayford Rita K. , Serba Desalegn D. , Xie Shaojun , Ayyappan Vasudevan , Thimmapuram Jyothi , Saha Malay C. , Wu Cathy H. , Kalavacharla Venu Kal
Published: March 2022

Background

Sustainable production of high-quality feedstock has been of great interest in bioenergy research. Despite the economic importance, high temperatures and water deficit are limiting factors for the successful cultivation of switchgrass in semi-arid areas. There are limited reports on the molecular basis of combined abiotic stress tolerance in switchgrass, particularly the combination of drought and heat stress. We used transcriptomic approaches to elucidate the changes in the response of switchgrass to drought and high temperature simultaneously.

Results

We conducted solely drought treatment in switchgrass plant Alamo AP13 by withholding water after 45 days of growing. For the combination of drought and heat effect, heat treatment (35 °C/25 °C day/night) was imposed after 72 h of the initiation of drought. Samples were collected at 0 h, 72 h, 96 h, 120 h, 144 h, and 168 h after treatment imposition, total RNA was extracted, and RNA-Seq conducted. Out of a total of 32,190 genes, we identified 3912, as drought (DT) responsive genes, 2339 and 4635 as, heat (HT) and drought and heat (DTHT) responsive genes, respectively. There were 209, 106, and 220 transcription factors (TFs) differentially expressed under DT, HT and DTHT respectively. Gene ontology annotation identified the metabolic process as the significant term enriched in DTHT genes. Other biological processes identified in DTHT responsive genes included: response to water, photosynthesis, oxidation-reduction processes, and response to stress. KEGG pathway enrichment analysis on DT and DTHT responsive genes revealed that TFs and genes controlling phenylpropanoid pathways were important for individual as well as combined stress response. For example, hydroxycinnamoyl-CoA shikimate/quinate hydroxycinnamoyl transferase (HCT) from the phenylpropanoid pathway was induced by single DT and combinations of DTHT stress.

Conclusion

Through RNA-Seq analysis, we have identified unique and overlapping genes in response to DT and combined DTHT stress in switchgrass. The combination of DT and HT stress may affect the photosynthetic machinery and phenylpropanoid pathway of switchgrass which negatively impacts lignin synthesis and biomass production of switchgrass. The biological function of genes identified particularly in response to DTHT stress could further be confirmed by techniques such as single point mutation or RNAi.
The effect of continuous intercostal nerve block vs. single shot on analgesic outcomes and hospital stays in minimally invasive direct coronary artery bypass surgery: a retrospective cohort study
Authors: Yao Youxiu , Xu Mao
Published: March 2022

Background

Minimally invasive direct coronary artery bypass (MIDCAB) grafting surgery is accompanied by severe pain. Although continuous intercostal nerve block (CINB) has become one of the multimodal analgesic techniques in single port thoracoscopic surgery, its effects on MIDCAB are unclear. The purpose of this study was to compare the effects of CINB and single shot on analgesic outcomes and hospital stays in patients undergoing MIDCAB in a real-world setting.

Methods

A retrospective cohort study was carried out at Peking University Third Hospital, China. Two hundred and sixteen patients undergoing MIDCAB were divided into two groups: a CINB group and a single block (SI) group. The primary outcome was postoperative maximal visual analog scale (VAS); secondary outcomes included the number of patients with maximal VAS ≤ 3, the demand for and consumed doses of pethidine and tramadol, and the length of intensive care unit (ICU) and hospital stays. The above data and the area under the VAS curve in the 70 h after extubation for the two subgroups (No. of grafts = 1) were also compared.

Results

The maximum VAS was lower in the CINB group, and there were more cases with maximum VAS ≤ 3 in the CINB group: CINB 52 (40%) vs. SI 17 (20%), P = 0.002. The percentage of cases requiring tramadol and pethidine was less in CINB, P = 0.001. Among all patients, drug doses were significantly lower in the CINB group [tramadol: CINB 0 (0–100) mg vs. SI 100 (0–225) mg, P = 0.0001; pethidine: CINB 0 (0–25) mg vs. SI 25 (0–50) mg, P = 0.0004]. Further subgroup analysis showed that the area under the VAS curve in CINB was smaller: 28.05 in CINB vs. 30.41 in SI, P = 0.002. Finally, the length of ICU stay was shorter in CINB than in SI: 20.5 (11.3–26.0) h vs. 22.0 (19.0–45.0) h, P = 0.011.

Conclusions

CINB is associated with decreased demand for rescue analgesics and shorter length of ICU stay when compared to single shot intercostal nerve block. Additional randomized controlled trial (RCT) is needed to support these findings.
Predictors of pre-hospital vs. hospital mortality due to road traffic injuries in an Iranian population: results from Tabriz integrated road traffic injury registry
Authors: Homayoun Sadeghi-Bazargani , Milad Jamali-Dolatabad , Mina Golestani , Parvin Sarbakhsh
Published: March 2022

Background

Road Traffic Injuries (RTIs) is considered as one of the main health challenges and causes of mortality, worldwide and especially in Iran. Predicting the place where RTIs-related death takes place is vital in decreasing this type of mortality. The purpose of the present study was to identify the predictors of RTI fatalities with respect to the place of death (hospital vs. pre-hospital) during the recent decade in East Azerbaijan Province, Iran.

Methods

Overall, 7347 RTI fatalities were retrieved from the road traffic injuries registry which is supported by the Forensic Medicine Organization in East Azerbaijan. Among these cases, 2758(37.5%)) were hospital deaths. The registered variables of these cases were analysed using bivariate and multiple logistic regression (STATA version 15).

Results

Out of 7347 deaths, 5862 (79.8%) were men and the rest were women 1485 (20.2%).The mean age was 40.3 (SD = 20.8). Of the total number of cases, 2758 (37.5%) died in hospital death and the rest 4589 (62.5) were pre-hospital death. According to the results of the present study, inter-city RTI (OR = 1.7, CI 95% = (1.5–2)) and RTIs inside the city of Tabriz (OR = 1.4, CI 95% = (1.2–1.6)) increases the chance of hospitals death. In addition, having a heavy counterpart vehicle compared to no counterpart vehicle decreased the chances of hospitals death (OR = 0.46, CI 95% = (0.39–0.55)) while motorcycle or bike counterpart vehicle compared to no counterpart vehicle increased the chances of hospital death (OR = 2.26, CI 95% = (1.59–3.22)). Also the users of the motorcycle or bike vehicle compared to the pedestrians increased the chances of hospital death (OR = 1.43, CI 95% = (1.19–1.71)) while any the other vehicle users compared to the pedestrians have significantly lower chances for hospital death. Other factors that increased hospitals death were transferring injured people by ambulance (OR = 1.3, CI 95% = (1.1–1.6)) and being elderly (OR = 1.5, CI 95% = (1.2–1.7)). Moreover, it was found that the annual trend of change in hospital death is strongly affected by the above-identified factors.

Conclusions

The effective predictors in hospital death were RTI location, type of counterpart vehicle, used vehicles and lighting condition. The identified factors related to the location of deaths by RTI can be divided into the RTI severity-related factors as well as factors related to the services quality and speed of delivery. According to the present results, through professional training of people in the field and providing immediate assistance in RTIs pre-hospital mortality can be significantly prevented.