bluuebunny/crossref_metadata_2025 huggingface dataset:
Prospective evaluation of anesthetic protocols during pediatric ophthalmic surgery
Authors: Ducloyer Jean-Baptiste , Couret Chloé , Magne Cécile , Lejus-Bourdeau Corinne , Weber Michel , Le Meur Guylène , Lebranchu Pierre
Published: October 2018

Purpose:

To date, no protocol of anesthesia for pediatric ophthalmic surgery is unanimously recognized. The primary anesthetic risks are associated with strabismus surgery, including oculocardiac reflex, postoperative nausea and vomiting, and postoperative pain.

Methods:

This was a prospective, monocentric, observational study conducted in a tertiary pediatric ophthalmic unit. Our anesthetic protocol for strabismus surgery included postoperative nausea and vomiting prevention using dexamethasone and ondansetron. No drug-based prevention of oculocardiac reflex or local/locoregional anesthesia was employed.

Results:

A total of 106 pediatric ophthalmic surgeries completed between November 2015 and May 2016 were analyzed. The mean patient age was 4.4 (range: 0.2–7.3, standard deviation: 2.4) years. Ambulatory rate was 90%. Oculocardiac reflex incidence was 65% during strabismus surgery (34/52), 50% during congenital cataract surgery (4/8), 33% during intramuscular injection of botulinum toxin (1/3), and 0% during other procedures. No asystole occurred. Postoperative nausea and vomiting incidence was 9.6% after strabismus surgery (5/52) and 0% following the other procedures. One child was hospitalized for one night because of persistent postoperative nausea and vomiting. Postoperative pain generally occurred early on in the recovery room and was quickly controlled. Its incidence was higher in patients who underwent strabismus surgery (27%) than in those who underwent other procedures (9%).

Conclusion:

Morbidity associated with ophthalmic pediatric surgery is low and predominantly associated with strabismus surgery. The benefit–risk ratio and cost-effectiveness of oculocardiac reflex prevention should be questioned. Our postoperative nausea and vomiting rate is low, thanks to the use of a well-managed multimodal strategy. Early postoperative pain is usually well-treated but could probably be more effectively prevented.
Towards SoMoLo journalism and SoMoLo activism: case studies of Macau netizens’ digital practices
Authors: Lin Zhongxuan , Zhao Yupei
Published: October 2018

The emergence and convergence of social, mobile and locative technologies have inspired scholars to develop the concept of ‘SoMoLo’ to study the changing forms of journalism and activism in this new context. This study therefore attempts to further develop this concept, rejuvenating the older ‘media and movement’ tradition and especially the ‘journalism and activism’ relationship to explore how and why SoMoLo journalism coexists interdependently with SoMoLo activism. Based on the research methods of virtual ethnography and interviews, we used Macau netizens’ digital practices as case studies to explain how SoMoLo journalism led to SoMoLo activism and its implications for Macau. We believe that this type of ‘local knowledge’ for Macau may reveal possible particularities and diversities of journalism and activism that may be valuable in a global context.
Rethinking archaeologies of pilgrimage
Authors: Jacob Skousen B
Published: October 2018

Pilgrimage instigates relationships between phenomena that produce hierophanies, or sacred, enchanting experiences. In this paper I argue that pilgrimage scholars should focus on the relational qualities of pilgrimage in order to rethink and produce more detailed, sensuous descriptions and analyses of this practice. This can be done by employing “relational approaches,” seen here as perspectives that recognize and prioritize the interconnections among persons, places, things, and substances. I further suggest that focusing on movement, the vitality of places and materials, and the senses is useful in thinking about the relational aspects of pilgrimage. Moreover, archaeologists are well-situated to investigate these phenomena and thus can and should push pilgrimage studies in new directions. I provide a case study of the Emerald Acropolis, an 11th-century Cahokian pilgrimage center. Cahokians traveled to Emerald on certain occasions and, while there, manipulated particular substances—earth and water—in ways that gathered otherworldly powers in affective ways.
It’s the journey not the destination: Maya New Year's pilgrimage and self-sacrifice as regenerative power
Authors: Harrison-Buck Eleanor , Runggaldier Astrid , Gantos Alex
Published: October 2018

This article examines Maya New Year's rites involving pilgrimage and bloodletting. We suggest that ceremonies today that center around the initiation of young men and involve self-sacrifice and long-distance pilgrimage to the mountains and coast may have pre-Hispanic roots. New Year's ceremonies express a core ontological principle of dualistic transformation involving physical change ( jal) from youth to adulthood and transference or replacement ( k’ex) of power in official leadership roles. This distinct way of knowing the world emphasizes one’s reciprocal relationship with it. We conclude that ancient Maya pilgrimage was not about acquiring a particular thing or venerating a specific place or destination. It was about the journey or what Timothy Ingold calls “ambulatory knowing.” The Maya gained cosmological knowledge, linking the movement of their body to the annual path of the sun and their sexuality and human regenerative power to earthly renewal, which required blood to be successful.
Two-stage examinations: Can examinations be more formative experiences?
Authors: Levy Dan , Svoronos Theodore , Klinger Mae
Published: October 2018

Two-stage examinations consist of a first stage in which students work individually as they typically do in examinations (stage 1), followed by a second stage in which they work in groups to complete another examination (stage 2), which typically consists of a subset of the questions from the first examination. Data from two-stage midterm and final examinations are used to assess the extent to which individuals improve their performance when collaborating with other students. On average, the group (stage 2) score was about one standard deviation above the individual (stage 1) score. While this difference cannot be interpreted as the causal effect of two-stage examinations on learning, it suggests that individuals experienced substantial performance gains when working in groups in an examination. This average performance gain was comparable with the average difference between the top performer of the group in stage 1 and the group’s stage 1 average, and was equivalent to about two-thirds of the difference between the “super student” score (i.e. the sum of the maximum score for each question in stage 1) and the group’s stage 1 average. This last result suggests that group collaboration takes substantial (albeit partial) advantage of the aggregate knowledge and skills of the group’s individual members. Student feedback about their experience with two-stage examinations reveal that that these types of examinations are generally perceived to be more helpful for learning and are less stressful than traditional examinations. Finally, using data on group gender compositions, we investigate the potential role of gender dynamics on group efficiency.
Dynamics of testosterone levels in patients with newly detected glucose abnormalities and acute myocardial infarction
Authors: Wang Anne , Arver Stefan , Flanagan John , Gyberg Viveca , Näsman Per , Ritsinger Viveca , Mellbin Linda G
Published: October 2018

Objective:

Low testosterone has been associated with increased cardiovascular risk and glucose abnormalities. This study explored the prevalence of low testosterone, dynamics over time and prognostic implications in acute myocardial infarction patients with or without glucose abnormalities.

Methods:

Male acute myocardial infarction patients (n = 123) and healthy controls (n = 124) were categorised as having normal or abnormal glucose tolerance (impaired glucose tolerance or diabetes) by oral glucose tolerance testing. Testosterone was measured at hospital admission, discharge, 3 and 12 months thereafter in patients. Patients and controls were followed for 11 years for major cardiovascular events (cardiovascular death/acute myocardial infarction/stroke/severe heart failure).

Results:

At hospital admission, more patients had low testosterone (⩽300 ng/dl) and lower median levels than controls (64 vs 28%; p < 0.001 and 243 vs 380 ng/dl; p < 0.01). At the subsequent time points, testosterone had increased to 311, 345 and 357 ng/dl. Patients with abnormal glucose tolerance had the highest prevalence (75%) of low levels. In adjusted Cox regression models, neither total nor free testosterone predicted major cardiovascular events.

Conclusion:

Low testosterone levels were common in male acute myocardial infarction patients in the acute phase, especially in the presence of abnormal glucose tolerance, but increased over time indicating that testosterone measured in close proximity to acute myocardial infarction should be interpreted with caution.
Development of a core outcome set for trials investigating the long-term management of bronchiectasis
Authors: Spargo Maureen , Ryan Cristín , Downey Damian , Hughes Carmel
Published: October 2018

Heterogeneity in outcomes measured in trials limits accurate comparison of bronchiectasis studies. A core outcome set (COS) is an agreed, standardized set of outcomes that should be measured in trials for specific clinical areas. A COS for bronchiectasis could encourage consistency in future studies. An overview of systematic reviews and qualitative study on outcome selection in bronchiectasis informed an initial list of outcomes. A Delphi panel ( n = 86) rated the importance of each outcome from 1 to 9 in 3 sequential questionnaires, as a means to achieve consensus: 1–3 = ‘of limited importance’; 4–6 = ‘important, but not critical’; and 7–9 = ‘critical’. Outcomes rated ‘critical’ by ≥70% of the panel were added to the COS. Eighty-two participants responded to the first questionnaire. Attrition between each questionnaire was 5%. After 3 rounds of questioning, 18 outcomes exceeded the threshold for consensus and were included in the COS. This study has achieved consensus on 18 outcomes that should be measured in trials of interventions for bronchiectasis. Selection of the highest ranked outcomes may represent a pragmatic means for comparison. Further research is required to condense the number of outcomes selected and to determine its relevance to interventions.
Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study
Authors: Ansel Gary M. , Brodmann Marianne , Keirse Koen , Micari Antonio , Jaff Michael R. , Rocha-Singh Krishna , Fernandez Eric J. , Wang Hong , Zeller Thomas ,   for the IN.PACT Global Study Investigators
Published: October 2018

Purpose: To report a post hoc analysis comparing outcomes between subjects who would have been included in the IN.PACT SFA randomized controlled trial vs those who would have been excluded. Methods: The 1406 subjects enrolled in the IN.PACT Global Study ( ClinicalTrials.gov identifier NCT01609296) were retrospectively assigned to a standard-use group (n=281) based on the inclusion and exclusion criteria from the randomized IN.PACT SFA trial; the remaining 1125 patients were assigned to the broader-use group. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated at 12 months. The composite primary safety endpoint was freedom from 30-day device- and procedure-related death plus freedom from 12-month target limb major amputation and clinically-driven target vessel revascularization (CD-TVR). Functional outcomes were evaluated with dedicated questionnaires. Results: Compared with the standard-use cohort, the broader-use lesions were longer, more calcified, and had more popliteal involvement, bilateral disease, and in-stent restenosis (p<0.001 for all). Freedom from 12-month CD-TLR by Kaplan-Meier analysis was 96.6% for the standard-use group and 91.6% for the broader-use group (p=0.005). The safety endpoint was 96.2% in the standard-use group and 91.0% in the broader-use group (p=0.003). The 12-month CD-TLR (3.4% standard-use vs 8.5% broader-use, p=0.004) and CD-TVR (4.2% standard-use vs 9.1% broader-use, p=0.008) were increased in the broader-use group. Twelve-month all-cause mortality was not increased (3.8% standard-use vs 3.4% broader-use, p=0.852). Conclusion: Post hoc analysis of the IN.PACT Global Study of real-world patients demonstrated consistent outcomes with significant clinical improvement to 12 months in subjects with complex lesions typically excluded from a randomized controlled trial.
Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry
Authors: Uberoi Raman , Setacci Carlo , Lescan Mario , Lorido Antonio , Murray David , Szeberin Zoltán , Zubilewicz Tomasz , Riambau Vincent , Chartrungsan Angsu , Tessarek Jörg , Iłżecki Marek , Gortz Hartmuth , Thenholt Matthias , Fattoum Maher , Buz Semih , Cao Piergiorgio , Benevento Domenico , Palasciano Giancarlo , Abdallah Feras , Boyle John , Llagostera Pujol S. , Esteban Carlos , Mosquera Nilo , Sanus Enrique Aracil , Negreira Ignacio Iglesias , Raymakers J.T.F.J. , van Herwaarden Joost , Pitoulias Georgios , Kratimenos Theodoros , Wahlgren Carl Magnus , Forssell Claes , Fulton Greg , Lonn Lars , Pedersen Gustav , Vergara Jorge , Silva Manuel Espindola , Cheng Stephen Wing-Keung , Anh Phan Minh , Calderas Carlos David , Bohan Patrick
Published: October 2018

Purpose:

To evaluate the safety and performance of the Treovance stent-graft.

Methods:

The global, multicenter RATIONALE registry ( ClinicalTrials.gov; identifier NCT03449875) prospectively enrolled 202 patients (mean age 73.0±7.8 years; 187 men) with abdominal aortic aneurysms (AAA) suitable for endovascular aneurysm repair (EVAR) using the Treovance. The composite primary safety endpoint was site-reported all-cause mortality and major morbidity. The primary efficacy outcome was clinical success. Further outcomes evaluated included technical success; stent-graft migration, patency, and integrity; endoleak; and aneurysm size changes.

Results:

Technical success was 96% (194/202); 8 patients had unresolved type I endoleaks at the end of the procedure. There was no 30-day mortality and 1% major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96%) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4%) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6% (95% CI 91.4% to 97.8%). Other estimates were 95.5% (95% CI 91.7% to 97.6%) for freedom from endoleak type I/III and 97.4% (95% CI 94.2% to 98.9%) for freedom from aneurysm expansion. Thirteen (6.4%) patients died; no death was aneurysm related.

Conclusion:

The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting.
Amplitude Instability of Somatosensory Evoked Potentials as an Indicator of Delayed Cerebral Ischemia in a Case of Subarachnoid Hemorrhage
Authors: Spalletti Maddalena , Orzalesi Vanni , Carrai Riccardo , Bucciardini Luca , Cossu Cesarina , Scarpino Maenia , Fainardi Enrico , Marinoni Marinella , Grippo Antonello , Amantini Aldo
Published: October 2018

We describe a 55-year-old male patient with a subarachnoid hemorrhage (SAH) as a result of left middle cerebral artery (MCA) aneurysm rupture, who underwent continuous electroencephalogram (EEG) and somatosensory evoked potential (cEEG-SEP) monitoring that showed an unusual SEP trend pattern. EEG was continuously recorded, and SEPs following stimulation of median nerves were recorded every 50 minutes, with the amplitude and latency of the cortical components automatically trended. An increase in intracranial pressure required a left decompressive craniectomy. cEEG-SEP monitoring was started on day 7, which showed a prolonged (24 hours) instability of SEPs in the left hemisphere. During this phase, left MCA vasospasm was demonstrated by transcranial Doppler (TCD), and computed tomography perfusion (CTP) showed a temporo-parieto-occipital ischemic penumbra. Following intravascular treatment, hypoperfusion and the amplitude of cortical SEPs improved. In our case, a prolonged phase of SEP amplitude instability during vasospasm in SAH correlated with a phase of ischemic penumbra, as demonstrated by CTP. In SAH, SEP instability during continuous monitoring is a pattern of alert that can allow treatments capable of avoiding irreversible neurological deterioration.
What gives them the right? Legal privilege and waivers of consent for research
Authors: Baker Francis X , Merz Jon F
Published: October 2018

Waivers of informed consent for research participation are permitted in the United States under the Common Rule, the Health Insurance Portability and Accountability Act regulations, and the US Food and Drug Administration’s Exception from Informed Consent rule for emergency research. We assess the novel question regarding what legal right researchers have to carry out research procedures on or about another person, be it experimental medical intervention, psychological or social manipulation, or invasion of privacy, without the permission of their subjects. Our analysis frames waivers of consent as a species of presumed consent, and we address the underlying empirical question of whether it is reasonable to believe that subjects from whom no consent is sought would in fact agree, if asked. A scoping review of what is known about participation and refusal rates in United States-based research suggests that a large minority, on average, do not agree to take part in research. Refusal rates vary widely. This suggests that, while researchers may assert the social utility of their studies are high enough to justify waivers, there is reason to suspect that many who would be enrolled under a waiver of consent would not want to be enrolled. We conclude that waivers should be rare and that institutional review boards and researchers must explicitly address study acceptability in the community at large and the target population of their proposed research.
CD11b-activated Src signal attenuates neuroinflammatory pain by orchestrating inflammatory and anti-inflammatory cytokines in microglia
Authors: Yang Mei , Xu Wenyun , Wang Yiru , Jiang Xin , Li Yingke , Yang Yajuan , Yuan Hongbin
Published: October 2018

Neuroinflammation plays an important role in the induction and maintenance of chronic pain. Orchestra of pattern-recognition receptor-induced pro-inflammatory and anti-inflammatory cytokines is critical for inflammation homeostasis. CD11b on macrophages could inhibit toll-like receptor (TLR) activation-induced inflammatory responses. However, the function of CD11b on microglia remains unknown. In the current study, we demonstrated that CD11b-deficient microglia cells produced more inflammatory cytokines, such as interleukin-6 and tumor necrosis factor alpha, while less anti-inflammatory cytokines. Signal transduction assay confirmed that nuclear factor-κB activation was increased in CD11b-deficient microglia cells, which resulted from decreased activation of Src. Inhibition of Src by PP1 increased inflammation in wild-type microglia cells significantly, but not in CD11b-deficient microglia cells. In vivo, CD11b-deficient mice were more susceptible to chronic constrictive injury-induced allodynia and hyperalgesia with significantly more inflammatory cytokines expression. All these results indicated that the regulatory function of CD11b-Src signal pathway on both inflammatory and anti-inflammatory cytokines in microglia cells is a potential target in neuropathic pain treatment.
Mouse mast cells and mast cell proteases do not play a significant role in acute tissue injury pain induced by formalin
Authors: Magnúsdóttir Elín I , Grujic Mirjana , Roers Axel , Hartmann Karin , Pejler Gunnar , Lagerström Malin C
Published: October 2018

Subcutaneous formalin injections are used as a model for tissue injury-induced pain where formalin induces pain and inflammation indirectly by crosslinking proteins and directly through activation of the transient receptor potential A1 receptor on primary afferents. Activation of primary afferents leads to both central and peripheral release of neurotransmitters. Mast cells are found in close proximity to peripheral sensory nerve endings and express receptors for neurotransmitters released by the primary afferents, contributing to the neuro/immune interface. Mast cell proteases are found in large quantities within mast cell granules and are released continuously in small amounts and upon mast cell activation. They have a wide repertoire of proposed substrates, including Substance P and calcitonin gene-related peptide, but knowledge of their in vivo function is limited. We evaluated the role of mouse mast cell proteases (mMCPs) in tissue injury pain responses induced by formalin, using transgenic mice lacking either mMCP4, mMCP6, or carboxypeptidase A3 (CPA3), or mast cells in their entirety. Further, we investigated the role of mast cells in heat hypersensitivity following a nerve growth factor injection. No statistical difference was observed between the respective mast cell protease knockout lines and wild-type controls in the formalin test. Mast cell deficiency did not have an effect on formalin-induced nociceptive responses nor nerve growth factor-induced heat hypersensitivity. Our data thus show that mMCP4, mMCP6, and CPA3 as well as mast cells as a whole, do not play a significant role in the pain responses associated with acute tissue injury and inflammation in the formalin test. Our data also indicate that mast cells are not essential to heat hypersensitivity induced by nerve growth factor.
Scripted communication for service standardisation? What analysis of conversation can tell us about the fast-food service encounter
Authors: Chan Mei Yuit , Chandra-Sagaran Uma
Published: October 2018

In highly routinised service encounter interactions, communication is often guided by service scripts that are the material embodiment of institutional expectations of how the service interaction is to be conducted. However, counter to common belief that scripted communication is well-controlled and homogeneous in its execution, observation of actual talk reveals interesting patterns and variations that reflect the ways in which participants make meaning of and perform their respective roles within the interaction towards achieving the overall goal of the service communication. Applying the analysis of speech functions and sequential order of talk in audio-recorded verbal exchanges between servers and customers at the service counter of a fast-food restaurant, acts in the fast-food service interaction are interpreted and explained in relation to management-prescribed service script, servers’ script-in-use and customers’ script within an institutional discourse framework. Findings from the study have important implications for service management and training as it addresses the tension between the practices on the ground and those sanctioned by the organisation.
Incidence of general surgical procedures in adult patients on extracorporeal membrane oxygenation
Authors: Juthani Biren K , Macfarlan Jennifer , Wu James , Beman Scott , Misselbeck Timothy S
Published: October 2018

Purpose

Extracorporeal membrane oxygenation use may predispose patients to developing conditions that require either consultation with a general surgeon or a general surgical procedure. We aimed to evaluate the incidence and outcomes of adult extracorporeal membrane oxygenation patients who underwent general surgical procedure.

Methods

This was a single institution retrospective study of adult extracorporeal membrane oxygenation patients from 2012 to 2015. Outcomes were compared between patients who underwent general surgical procedure with those that did not.

Results

Of the 115 patients, 54 (46.9%) required a general surgeon while 42 (36.5%) required a general surgical procedure. No significant differences were observed in mortality (35.7% vs. 46.6%; p = 0.256) and extracorporeal membrane oxygenation-related complications (45.7% vs. 32.5%; p = 0.175). Patients with general surgical procedure had longer extracorporeal membrane oxygenation duration (13 vs. 5 days; p < 0.0001), longer length of stay (36 vs. 15 days; p = 0.0005), more wound infections (19.05% vs. 5.5%; p = 0.029), more urinary tract infections (38.1% vs. 10.96%; p = 0.0006), and more pulmonary emboli (19.05% vs. 5.48%; p = 0.029). In general surgical procedure patients, no difference in bleeding complications was observed regardless of anti-coagulation status (29.4% vs. 16%; p = 0.44).

Conclusion

Common general surgical procedures are safe and feasible in adult extracorporeal membrane oxygenation patients. Duration of extracorporeal membrane oxygenation was longer for patients requiring general surgical procedure. Despite the common use of anticoagulants, there was no increase in bleeding events in general surgical procedure patients.
Faculty Attitudes Toward Rhinology Fellowship Training: A Survey of Rhinology Fellowship Programs
Authors: Riley Charles A. , Soneru Christian P. , Husain Qasim , Gray Stacey T. , Senior Brent A. , Tabaee Abtin
Published: October 2018

Background

The number of rhinology fellowship programs has grown rapidly over the past decade. To date, no standardization or accreditation process exists, raising the potential for disparate programs. The attitudes of faculty regarding training are important to elucidate the educational experience of rhinology fellowship.

Methods

An anonymous, web-based survey of rhinology faculty assessed the subjective attitudes toward various domains of fellowship training including surgery, office-based procedures, research, and career development. A 5-point Likert-type scale assessing importance was used (1—not at all important, 5—extremely important).

Results

A total of 34 faculty (response rate 35.8%) completed the survey. The surgical procedures that received the highest mean importance scores were endoscopic surgery for advanced inflammatory disease (median = 5), cerebrospinal fluid leak closure (5), and extended endoscopic sinus surgery (5). The procedures with the lowest scores were nasal valve repair (2), inferior turbinate surgery (3), and open approaches to the sinuses (4). A wide range of responses was noted for the minimum target number of fellow cases for the surveyed procedures. Higher importance scores were noted for direct attending supervision (5) when compared to fellow autonomy (4, P < .001) or shadowing (3.5, P < .001) in the operating room. Higher scores were noted for career preparation in academic (4) versus private practice (3, P < .001) and providing opportunities for clinical (4) versus basic science research (2, P < .001). The majority of faculty felt that there were too many fellowship positions with respect to the market place for private practice (58.8%), academic jobs (85.3%), and overall societal need (61.8%).

Conclusion

A range of faculty attitudes with respect to fellowship training was noted in this study. Continued assessment and refinement of the educational experience in rhinology fellowships is necessary.
Two-Year Follow-Up and Remodeling Kinetics of ChonDux Hydrogel for Full-Thickness Cartilage Defect Repair in the Knee
Authors: Wolf Matthew T. , Zhang Hong , Sharma Blanka , Marcus Norman A. , Pietzner Uwe , Fickert Stefan , Lueth Achim , Albers G. H. Robert , Elisseeff Jennifer H.
Published: October 2018

Objective

To determine performance and repair kinetics of the ChonDux hydrogel scaffold for treating focal articular cartilage defects in the knee over 24 months.

Design

This assessor-blinded trial evaluates ChonDux hydrogel scaffold implantation in combination with microfracture in 18 patients across 6 sites. Male and female patients 18 to 65 years of age with full-thickness femoral condyle defects 2 to 4 cm2 in area were enrolled. Eligible patients received ChonDux treatment followed by rehabilitation. Defect volume fill was evaluated after 3, 6 (primary outcome), 12, 18, and 24 months by assessor blinded magnetic resonance imaging (MRI) analysis. Secondary outcomes were T2-weighted MRI relaxation time and patient surveys via visual analogue scale (VAS) pain and International Knee Documentation Committee (IKDC) knee function scoring.

Results

ChonDux maintained durable tissue restoration over 24 months with final defect percent fill of 94.2% ± 16.3% and no significant loss of fill volume at any time points. Tissues treated with ChonDux maintained T2 relaxation times similar to uninjured cartilage between 12 and 24 months. VAS pain scoring decreased between 1 and 6 weeks, and IKDC knee function scores improved by approximately 30.1 with ChonDux over 24 months.

Conclusion

ChonDux treatment is a safe adjunct to microfracture therapy and promotes stable restoration of full thickness articular cartilage defects for at least 24 months.
Judicial independence as a precondition for mutual trust? The CJEU in Minister for Justice and Equality v. LM
Authors: Bárd Petra , van Ballegooij Wouter
Published: October 2018

This article discusses the relationship between judicial independence and intra-European Union (EU) cooperation in criminal matters based on the principle of mutual recognition. It focuses on the recent judgment by the Court of Justice of the EU in Case C-216/18 PPU Minister for Justice and Equality v. LM. In our view, a lack of judicial independence needs to be addressed primarily as a rule of law problem. This implies that executing judicial authorities should freeze judicial cooperation in the event should doubts arise as to respect for the rule of law in the issuing Member State. Such a measure should stay in place until the matter is resolved in accordance with the procedure provided for in Article 7 TEU or a permanent mechanism for monitoring and addressing Member State compliance with democracy, the rule of law and fundamental rights. The Court, however, constructed the case as a possible violation of the right to a fair trial, the essence of which includes the requirement that tribunals are independent and impartial. This latter aspect could be seen as a positive step forward in the sense that the judicial test developed in the Aranyosi case now includes rule of law considerations with regard to judicial independence. However, the practical hurdles imposed by the Court on the defence in terms of proving such violations and on judicial authorities to accept them in individual cases might amount to two steps back in upholding the rule of law within the EU.
Quality assessment of controlled clinical trials published in Orthopaedics and Traumatology journals in Spanish: An observational study through handsearching and evidence mapping
Authors: Arevalo-Rodriguez Ingrid , Muñoz Edgar , Buitrago-Garcia Diana , Nuñez-González Solange , Montero-Oleas Nadia , Garzón Vanessa , Pardo-Hernandez Hector , Bonfill Xavier
Published: October 2018

Few Orthopaedics and Traumatology journals from Latin America and Spain are indexed in major databases; controlled clinical trials published in these journals cannot be exhaustively retrieved using electronic literature searches. We aimed to identify, describe and assess the quality of controlled clinical trials published in Orthopaedics and Traumatology journals from Latin America and Spain through handsearching and evidence mapping methods. We identified controlled clinical trials published in eligible Orthopaedics/Traumatology journals in Spanish until July 2017 by handsearching. Data were extracted for controlled clinical trials main characteristics and the Cochrane risk of bias tool was used to assess the controlled clinical trials methodological quality. In addition, we mapped the main findings of these trials. As a result, we assessed 5631 references in 29 eligible journals of which 57 were controlled clinical trials (1.0%). Controlled clinical trials were published between 1995 and 2017 at a rate of 2.5 per year. Journals from Spain and Mexico published around 63% of the controlled clinical trials identified. The median sample size of patients enrolled was 60 (range = 30–300 participants). About conditions assessed, 38.5% of controlled clinical trials assessed issues related to knee conditions, 15.7% about hip and 10.5% about trauma or spine. The risk of bias domains most affected was selective reporting bias and random sequence generation. In addition, only two and seven trials had low risk of bias in all items related to participant/personnel and outcome assessment blindings, respectively. More than 40% of studies did not report differences on benefits/harms between the interventions assessed. As a conclusion, the number of controlled clinical trials published in Orthopaedics/Traumatology journals from Latin America and Spain is low. These controlled clinical trials had important methodological shortcomings and were judged as unclear or high risk of bias. These trials are now available in CENTRAL for their potential inclusion in systematic reviews and other documents of synthesis.
Bullous pemphigoid associated with ipilimumab therapy for advanced metastatic melanoma
Authors: Hanley T , Papa S , Saha M
Published: October 2018

Lesson

Immunotherapy is now being routinely used in the management of many cancers. It is therefore vital that all clinicians are aware of the diverse array of cutaneous manifestations that can result from their use, which can vary from mild to life threatening.
Invasion of the Mind Snatchers: A Nation Full of Traumatic Memories
Authors: Loftus Elizabeth F. , Teitcher Jennifer
Published: October 2018

The new national survey by Patihis and Pendergrast (this issue, p. 3) suggests that millions of people may have recovered traumatic memories that they spent large parts of their lives not thinking about. We wondered whether they are better off and suggest that more than a few may be worse off rather than better. Given this risk of therapy, should therapists be warning patients of the potential risks before conducting therapy? The answer is not clear as warning about risks can be risky itself. Overall, we propose that with so many people living with “recovered” memories, future research now needs to address whether they are indeed better off and which methods would help achieve that goal.
Dr Michael Bell: A Surgeon With Boundless Ingenuity
Authors: Sardiwalla Yaeesh , Morris Steven F.
Published: October 2018

Dr Michael Bell was born in Kingston, Ontario, on October 14, 1944. He was always a curious child who exhibited a tendency toward innovation and experimentation. Dr Bell was accepted into the MD program at the University of Toronto graduating in 1969 before completing his plastic surgery residency there. Dr Bell accepted a position bringing hand and microsurgery expertise to the University of Ottawa in 1976. He pioneered the widespread use of local anesthetic for surgery and developed an innovative relationship with Leonard Lee of Lee Valley tools. Canica Design created several surgical products, including an enhanced design on the traditional scalpel handle and wound closure devices. Dr Bell had a passion for making improvements to enable surgeons to advance patient care. He encourages a philosophy of critical thinking that contributes to continued design in plastic surgery. Dr Bell continues to design and craft new devices with alumni of the Lee Valley Tools team.
Japanese Women Managers’ Employee-Oriented Communication Styles: An Analysis Using Constructivist Grounded Theory
Authors: Sueda Kiyoko
Published: October 2018

The number of women managers in Japan remains small, and little empirical research has been conducted on their communication styles. Therefore, this article reports the results of a qualitative study using the constructivist grounded theory to analyze data gathered on the communication styles of Japanese women managers. It enumerates the results of semistructured interviews with 27 participants comprising women managers and their male and female employees in both foreign-affiliated and Japanese companies in various industries. The findings indicate Japanese women managers go beyond the traditional dichotomies drawn between task- and relationship-oriented communication to engage in employee-oriented communication by facilitating an open and friendly work environment while motivating their employees to collaborate as a team to achieve their professional goals. Japanese women managers are often encouraged to communicate in such a style because it reflects the stereotypical female role in Japanese society and, as such, is well received by their colleagues.
Leader strain and follower burnout: Exploring the role of transformational leadership behaviour
Authors: Diebig Mathias , Poethke Ute , Rowold Jens
Published: October 2018

This study contributes to leadership literature by linking leader strain with followers’ level of burnout while considering leaders’ transformational leadership behaviour. The study provides promising insights into the field of leadership theory by shedding light on the nature of leadership under stress. The sample consisted of 294 dyads of leaders and their followers, who provided information on transformational leadership style, levels of perceived strain, and burnout via an online survey. Results show that (1) strained leaders display less transformational leader behaviours, (2) leaders’ transformational behaviours reduce follower burnout, and (3) the relationship between leader strain and follower burnout is mediated by transformational leadership behaviours. This study contributes to the existing literature by exploring the link between leaders’ strain and followers’ burnout within a health-oriented leadership framework, and uncovers direct and indirect effects seen as a result of transformational leadership.
Correlation of the Stiffness of Hepatocellular Carcinoma and Surrounding Liver Parenchyma by Point Shear Wave Elastography
Authors: Chaopathomkul Bundit , Boonsirisak Ornalin , Pongpirul Krit
Published: October 2018

The purpose of this study was to assess the correlation between hepatocellular carcinoma (HCC) and surrounding liver parenchyma stiffness using point shear wave elastography (pSWE). HCC was diagnosed using the criteria of the American Association for the Study of Liver Diseases. Liver fibrosis was classified into three groups (nonsignificant fibrosis, significant fibrosis, and cirrhosis). pSWE was performed on the HCC and the adjacent hepatic parenchyma and was expressed as kilopascal (kPa). A total of 59 HCC patients with 64 tumors were included in the study. The mean stiffnesses of HCC and liver background were 9.25 ± 3.76 and 10.84 ± 4.81 kPa, respectively. There was no statistical significance in HCC stiffness in any stage of liver fibrosis. Low HCC/liver background stiffness ratio was noted in the cirrhotic group and statistically significant in two comparison groups (cirrhosis vs significant fibrosis and cirrhosis vs nonsignificant fibrosis), with P < .001. In this cohort, HCC stiffness alone demonstrated no statistically significant difference in various stages of liver fibrosis.
Preventing clinically important deterioration with single-inhaler triple therapy in COPD
Authors: Naya Ian , Compton Chris , Ismaila Afisi S. , Birk Ruby , Brealey Noushin , Tabberer Maggie , Zhu Chang-Qing , Lipson David A. , Criner Gerard
Published: October 2018

Clinically important deterioration (CID) is a novel composite end-point (lung function, health status, exacerbations) for assessing disease stability in patients with chronic obstructive pulmonary disease (COPD).

We prospectively analysed CID in the FULFIL study. FULFIL (ClinicalTrials.govNCT02345161; randomised, double-blind, double-dummy, multicentre study) compared 24 weeks of once daily, single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 µg with twice daily budesonide/formoterol (BUD/FOR) 400/12 μg in patients aged ≥40 years with symptomatic advanced COPD (Global Initiative for Chronic Obstructive Lung Disease group D). A subset of patients received study treatment for up to 52 weeks. Time to first CID event was assessed over 24 and 52 weeks using two approaches for the health status component: St George's Respiratory Questionnaire and COPD assessment test. FF/UMEC/VI significantly reduced the risk of a first CID event by 47–52%versusBUD/FOR in the 24- and 52-week populations using both CID definitions (p<0.001).

The median time to first CID event was ≥169 days and ≤31 days with FF/UMEC/VI and BUD/FOR, respectively. Only stable patients with no CID at 24 weeks demonstrated sustained clinically important improvements in lung function and health status at 52 weeksversusthose who had experienced CID.

Once daily, single-inhaler FF/UMEC/VI significantly reduced the risk of CIDversustwice daily BUD/FOR with a five-fold longer period without deterioration.
Cancer-Related Cognitive Outcomes Among Older Breast Cancer Survivors in the Thinking and Living With Cancer Study
Authors: Mandelblatt Jeanne S. , Small Brent J. , Luta Gheorghe , Hurria Arti , Jim Heather , McDonald Brenna C. , Graham Deena , Zhou Xingtao , Clapp Jonathan , Zhai Wanting , Breen Elizabeth , Carroll Judith E. , Denduluri Neelima , Dilawari Asma , Extermann Martine , Isaacs Claudine , Jacobsen Paul B. , Kobayashi Lindsay C. , Holohan Nudelman Kelly , Root James , Stern Robert A. , Tometich Danielle , Turner Raymond , VanMeter John W. , Saykin Andrew J. , Ahles Tim
Published: October 2018

Purpose

To determine treatment and aging-related effects on longitudinal cognitive function in older breast cancer survivors.

Methods

Newly diagnosed nonmetastatic breast cancer survivors (n = 344) and matched controls without cancer (n = 347) 60 years of age and older without dementia or neurologic disease were recruited between August 2010 and December 2015. Data collection occurred during presystemic treatment/control enrollment and at 12 and 24 months through biospecimens; surveys; self-reported Functional Assessment of Cancer Therapy-Cognitive Function; and neuropsychological tests that measured attention, processing speed, and executive function (APE) and learning and memory (LM). Linear mixed-effects models tested two-way interactions of treatment group (control, chemotherapy with or without hormonal therapy, and hormonal therapy) and time and explored three-way interactions of ApoE (ε4+ v not) by group by time; covariates included baseline age, frailty, race, and cognitive reserve.

Results

Survivors and controls were 60 to 98 years of age, were well educated, and had similar baseline cognitive scores. Treatment was related to longitudinal cognition scores, with survivors who received chemotherapy having increasingly worse APE scores ( P = .05) and those initiating hormonal therapy having lower LM scores at 12 months ( P = .03) than other groups. These group-by-time differences varied by ApoE genotype, where only ε4+ survivors receiving hormone therapy had short-term decreases in adjusted LM scores (three-way interaction P = .03). For APE, the three-way interaction was not significant ( P = .14), but scores were significantly lower for ε4+ survivors exposed to chemotherapy (−0.40; 95% CI, −0.79 to −0.01) at 24 months than ε4+ controls (0.01; 95% CI, 0.16 to 0.18; P < .05). Increasing age was associated with lower baseline scores on all cognitive measures ( P < .001); frailty was associated with baseline APE and self-reported decline ( P < .001).

Conclusion

Breast cancer systemic treatment and aging-related phenotypes and genotypes are associated with longitudinal decreases in cognitive function scores in older survivors. These data could inform treatment decision making and survivorship care planning.
Black Hair Haptics
Authors: Morrison Amani
Published: October 2018

In the United States, black hair—that is, the hair of African-descended peoples—has a long and fraught political, economic, and social history that informs its contemporary reception: at the interstices of self-making, aesthetic expression, and respectability politics, black hair has been both overdetermined and underexplored as a site of intellectual inquiry. This essay aims to offer a critical examination of natural black hair as a central site of interpersonal negotiation for black women in the United States. Drawing on performance studies, cultural studies, and black feminist studies, I offer black hair haptics as an analytic for the racialized and gendered dimensions of quotidian public interpersonal engagement with black hair as an extension of the black body. I argue that black hair is a unique site of analysis for transgressions of socially appropriate interpersonal interaction.
Raising the status of software in research: A survey-based evaluation of the Software Sustainability Institute Fellowship Programme
Authors: Sufi Shoaib , Jay Caroline
Published: October 2018

Background: This paper reports the results of an evaluation of the Software Sustainability Institute’s Fellowship Programme, which focused on identifying and categorising the benefits that the fellowship has afforded its recipients, via a series of open questions.

Methods: The evaluation took the form of a survey open to people awarded Fellowships between 2012 and 2016, which asked people to report the effect that the programme had had on them, their institutions, their research domains and their careers.

Results: The results show that the Fellowship plays a wide-ranging role in supporting communities of best practice and skills transfer, and that a significant benefit is the way it has raised the profile of software in research, and those people who develop and advocate for it.

Conclusions: The evaluation of the programme has shown the need to support research software in situ and credit the engineers and researchers who are working in this important area that supports reproducibility, reuse and the integrity of research investments.
Lesões de armazenamento durante a conservação de concentrado de hemácias
Authors: Andretta Angélica Teresinha , Justi Amanda , Grando Luciana G. , Siqueira Luciano De O.
Published: October 2018

Introdução: Os Hemocentros realizam diversos procedimentos preconizados pelo Ministério da Saúde (MS) para garantir a qualidade dos hemocomponentes produzidos, os quais devem ser avaliados quanto a parâmetros relacionados à sua funcionalidade ao longo de seu período de armazenamento. Os eritrócitos armazenados em bolsas plásticas à temperatura de 4 ± 2 °C sofrem alterações graduais, sendo conhecidas como lesões de armazenamento. Tais alterações podem inviabilizar a utilização do Concentrado de Hemácias (CH) ou diminuir sua eficácia pós-transfusão. Objetivos: A presente revisão tem por objetivo relatar as principais alterações hematológicas, morfológicas e bioquímicas ocorridas durante o armazenamento de CH. Métodos: Foi realizada uma revisão sistemática de literatura em livros-texto, na legislação vigente e nas bases eletrônicas Lilacs, PubMed e Scielo em publicações relevantes entre os anos de 1986 e 2017. Resultados: Os resultados mostram que eritrócitos sofrem modificações durante seu armazenamento, tais como: alterações morfológicas e bioquímicas, elevação da concentração de potássio e redução da concentração de glicose, as quais podem inviabilizar o uso dos CH e/ou reduzir sua eficácia pós-transfusional. Conclusões: A partir dos resultados apresentados nesta revisão, o monitoramento das lesões de estoque dos CH corrobora a qualidade da terapêutica transfusional.Descritores: Controle de qualidade; Eritrócitos; Serviço de transfusão; Preservação; Transfusão.