Evaluation Of Clinical Performance Research Articles

Clinical performance evaluation of the Idylla\u2122 EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer

BackgroundDetection of epidermal growth factor receptor (EGFR) mutations in exons 18–21 is recommended in all patients with advanced Non-small-cell lung carcinoma due to the demonstrated efficiency of the standard therapy with tyrosine kinase inhibitors in EGFR-mutated patients. Therefore, choosing a suitable technique to test EGFR mutational status is crucial to warrant a valid result in a short turnaround time using the lowest possible amount of tissue material.The Idylla™ EGFR Mutation Test is a simple, fast and reliable method designed for the detection of EGFR mutations from formalin-fixed paraffin-embedded samples.The aim of this study was the Clinical Performace Evaluation of the Idylla™ EGFR Mutation Test on the Idylla™ System.MethodsEGFR mutational status was determined on 132 archived formalin-fixed paraffin-embedded tissue sections with Idylla™ technology. Results were compared with the results previously obtained by routine method in the reference lab (Therascreen® EGFR RGQ PCR v2, Qiagen in Molecular Pathology lab, Hospital Universitario Virgen del Rocío de Sevilla).ResultsThe overall agreement between results obtained with the Idylla™ EGFR Mutation Test and the Comparator test method was 95.38% (with 1-sided 95% lower limit of 91.7%) showing Positive Diagnostic Agreement of 93.22% and Negative Diagnostic Agreement of 97.18%, with a Limit Of Detection ≤5%.ConclusionsThe Idylla™ EGFR Mutation Test passed its clinical validity performance characteristics for accuracy.

Immune Correlates of Protection Against Human Cytomegalovirus Acquisition, Replication, and Disease.

Human cytomegalovirus (HCMV) is the most common infectious cause of infant birth defects and an etiology of significant morbidity and mortality in solid organ and hematopoietic stem cell transplant recipients. There is tremendous interest in developing a vaccine or immunotherapeutic to reduce the burden of HCMV-associated disease, yet after nearly a half-century of research and development in this field we remain without such an intervention. Defining immune correlates of protection is a process that enables targeted vaccine/immunotherapeutic discovery and informed evaluation of clinical performance. Outcomes in the HCMV field have previously been measured against a variety of clinical end points, including virus acquisition, systemic replication, and progression to disease. Herein we review immune correlates of protection against each of these end points in turn, showing that control of HCMV likely depends on a combination of innate immune factors, antibodies, and T-cell responses. Furthermore, protective immune responses are heterogeneous, with no single immune parameter predicting protection against all clinical outcomes and stages of HCMV infection. A detailed understanding of protective immune responses for a given clinical end point will inform immunogen selection and guide preclinical and clinical evaluation of vaccines or immunotherapeutics to prevent HCMV-mediated congenital and transplant disease.

Establishment and clinical performance evaluation of 2019 novel coronavirus antibody colloidal gold detection method

Objective To establish a colloidal gold technique assay for the rapid detection of immunoglobulin(Ig) M and IgG antibodies against 2019 novel coronavirus (2019-nCoV) and to evaluate its clinical performance. Methods A total of 278 patients who were treated at Wuhan Hankou Hospital and the People's Hospital of Honghu from February 12, 2020 to February 20, 2020 were collected. According to the diagnostic criteria, 89 patients were confirmed with 2019-nCoV nucleic acid positive diagnosis, and 189 were 2019-nCoV nucleic acid-negative suspected patients. A total of 273 medical examiners from Nanfang Hospital, Southern Medical University from 2015 to 2018 were selected as controls. The serum samples of patients were collected. 2019-nCoV nucleic proteins were obtained from prokaryotic expression vectors. Indirect IgM and IgG colloidal gold techniques were established by using recombinant N protein. 2019-nCoV nucleic acid detection by reverse transcription-polymerase chain reaction (RT-PCR) was used as control. Serum specimens were tested for 2019-nCoV IgM and IgG. The specificity and sensitivity of colloidal gold assay were analyzed. Results The sensitivity and specificity of IgM detection reagents were 78.7% and 98.2%, respectively, those of IgG detection reagents were 73.0% and 99.3%, respectively, and those of IgM combined with IgG detection were 87.6% and 98.2%, respectively. For suspected patients with negative 2019-nCoV nucleic acid, the positive rates of IgM and IgG were 59.8% (113/189) and 52.9% (100/189), respectively, and the positive rate of IgM combined with IgG detection was 66.1% (125/189). Conclusion This reagent of 2019-nCoV antibodies detection (colloidal gold technique) fulfills the requirement for clinical application with high specificity and sensitivity, which can be served as a supplementary detection method for 2019-nCoV nucleic acid detection by RT-PCR. Key words: Coronavirus infection; Novel coronavirus; Gold colloid; Antibodies; Clinical performance

Research Note—Dyadic OSCE Subscales: Measuring Students’ Ability to Work With Parents and LGBTQ Children

ABSTRACT This article presents the results of two pilot studies focused on examining social work students’ ability to interview two clients at once to provide evidence supporting the use of new dyadic subscales. Students participated in a simulation scenario with either a parent and bisexual child or a parent and transgender child. Licensed social workers rated the students by using two dyadic subscales: five items designed to assess students’ communication skills in a dyadic client interview and five items designed to evaluate students’ reflections on their experience facilitating a dyadic client interview. This article provides initial reliability scores and describes how subscale items improved internal consistency for the objective structured clinical examination Performance Rating Scale and Reflection Rating Scale.

Halcyon clinical performance evaluation: A log file-based study in comparison with a C-arm Linac

PurposeThe aim of this study is to compare the dosimetric and mechanical accuracy of Volumetric Modulation Arc Therapy (VMAT) delivery on the Halcyon, a recent ring-shaped Treatment Delivery System (TDS) featuring fast rotating gantry, with a conventional C-arm Linac. MethodsThe comparison was performed via log file analysis, where mechanical parameters of related components was extracted. 480 and 3951 VMAT log files of clinically delivered fractions from a Halcyon and a TrueBeam Linac were analyzed respectively. The relations between mechanical parameters and errors were extensively explored to further investigate the differences between the two Linacs. The mechanical parameter fluctuations were taken into account for dose recalculations, and the Dose Volume Parameters (DVP) on the PTV were evaluated to quantify such dosimetric variations. ResultsThe Multi-Leaf Collimator (MLC) leaf mean Root Mean Square (RMS) errors were 0.028 mm and 0.031 mm for Halcyon and TrueBeam respectively. Maximum systematic error on the MLC leaves introduced by the gravity effect were 0.04 mm and 0.01 mm for the Halcyon and TrueBeam respectively. Thanks to the O-ring design, the Halcyon achieved 0.035° in mean RMS error in gantry angle compared with the 0.065° of the TrueBeam. Overall mechanical errors introduced similar levels of dose-volume parameter variations (about 0.1%) on both Linacs. Conclusion: The Halcyon TDS can achieve similar mechanical leaf positioning accuracy compared with the TrueBeam TDS with a doubled delivery speed. In terms of dosimetric accuracy, The DVP standard deviations on the studied TB are generally larger than that on the Halcyon.

Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses

Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses

Characterization and analytical validation of a new antigenic rapid diagnostic test for Ebola virus disease detection.

Hemorrhagic fever outbreaks are difficult to diagnose and control in part because of a lack of low-cost and easily accessible diagnostic structures in countries where etiologic agents are present. Furthermore, initial clinical symptoms are common and shared with other endemic diseases such as malaria or typhoid fever. Current molecular diagnostic methods such as polymerase chain reaction require trained personnel and laboratory infrastructure, hindering diagnostics at the point of need, particularly in outbreak settings. Therefore, rapid diagnostic tests such as lateral flow can be broadly deployed and are typically well-suited to rapidly diagnose hemorrhagic fever viruses, such as Ebola virus. Early detection and control of Ebola outbreaks require simple, easy-to-use assays that can detect very low amount of virus in blood. Here, we developed and characterized an immunoassay test based on immunochromatography coupled to silver amplification technology to detect the secreted glycoprotein of EBOV. The glycoprotein is among the first viral proteins to be detected in blood. This strategy aims at identifying infected patients early following onset of symptoms by detecting low amount of sGP protein in blood samples. The limit of detection achieved by this sGP-targeted kit is 2.2 x 104 genome copies/ml in plasma as assayed in a monkey analytical cohort. Clinical performance evaluation showed a specificity of 100% and a sensitivity of 85.7% when evaluated with plasma samples from healthy controls and patients infected with Zaire Ebola virus from Macenta, Guinea. This rapid and accurate diagnostic test could therefore be used in endemic countries for early detection of infected individuals in point of care settings. Moreover, it could also support efficient clinical triage in hospitals or clinical centers and thus reducing transmission rates to prevent and better manage future severe outbreaks.

Education promotion based on "mobile technology" in the Critical Care Nursing Department: Four-phase intervention.

INTRODUCTION:Evaluation of students’ clinical performance is an essential part of nursing education. Mobile technology is one of the new methods of evaluation that has opened a new horizon for nursing professors. Therefore, this study aimed to design, implement, and evaluate mobile health technology in critical care nursing department in four-phase intervention.METHODS:This study was a four-stage educational intervention in which all postgraduate students of intensive care nursing in Isfahan University of Medical Sciences participated in the study. The four steps were designing and developing a logbook, needs assessment, designing and implementing an Android app, and evaluating users (students) of the Android app. Subjects’ satisfaction scores were collected using a researcher-made questionnaire with 14 questions. Data were analyzed using SPSS 14 software.RESULTS:In this study, a clinical practice evaluation app was designed at four levels of access (student, professor, department manager, and faculty dean). The results showed that more than half of app users reported this technology in terms of an overall response to the tool (87.5%), tool specificity (100%), the amount of information displayed (75%), page layout (62.5%), information rate (75%), recall information (87.5%), and ease of doing instructions (100%) were positive.CONCLUSION:Evaluation of clinical practice using technology was associated with increasing students’ satisfaction with evaluation method. In addition, this application enabled the simultaneous interaction between the professor with the higher and lower ranks, including the department manager and student and vice versa and the simultaneous recording of this interaction.

The Evaluation of Clinical Pharmacy services Performance at Community Health centers of sebatik island regency of Nunukan province of north Kalimantan (Indonesia-Malaysia Border)

Health is a basic human right and one of the prosperity elements. However, in its implementation, health services are still not relatively optimal, notably for people living in underdeveloped, border, and island regions. This study primarily aimed to examine the performance of clinical pharmacy services based on the rules of the Indonesian Minister of Health Number 74 of 2016 concerning pharmaceutical service standards in the community health center. This study applied a descriptive-correlative model with a quantitative approach carried out in all Sebatik Island community health centers. All data were analyzed based on seven aspects of clinical pharmacy services consisting of assessment and prescription services, drug information service, counseling, patient visit, drug side effects monitoring, drug therapy monitoring, and the use of medical evaluation. Data collection was conducted by observation using a list of viewers, questionnaires, and interviews, equipped with retrospective data through documentary examination to give a clear depiction. The results of this study showed that the performance of clinical pharmacy services at Sebatik Island community health centers was as follows: zero aspect (0%) was at very high criteria, two aspects (29%) were at high criteria, zero aspect (0%) was at medium criteria, two aspects (29%) were at low criteria, and three aspects (43%) were at very low criteria. The average performance of clinical pharmacy services due to the seven aspects was 52% or considered in low level.

Comparative evaluation of clinical performance of two self-etch adhesive systems with total-etch adhesive system in noncarious cervical lesions: An in vivo study.

Background:The growing demands for esthetic restorations have stimulated intensive research in the field of adhesive dentistry. Dental adhesive systems are used to promote adhesion between composite resins and dental structure. In the fundamental principles of adhesion, the primary mechanism contributing to the formation of adhesion is micromechanical bonding between the restoration and the tooth. The bond strength of self-etching adhesives to dentin was found to be almost equal to that of total-etch adhesives. The aim of the present prospective, double-blind, randomized controlled clinical trial was to evaluate and compare the clinical performance of two self-etch adhesive systems with total-etch adhesive system in noncarious cervical lesions (NCCLs).Materials and Methods:In each patient, three teeth were randomly assigned according to the adhesive system used to Group A (total-etch adhesive system), Group B (two-bottle self-etch adhesive system), and Group C (one-bottle self-etch adhesive system). The clinical efficacy of these adhesive systems was determined by evaluating the retention rate, marginal integrity, and postoperative sensitivity at the following three levels: baseline, 6 months, and 18 months by following the Modified USPHS criteria introduced by Vanherle et al.Results:In the present study, the retention rate at 18 month in Group A, Group B, and Group C of 96%, 92%, and 92% was observed, respectively. A marginal integrity at 18 months was 88%, 80%, and 84% for Group A, Group B, and Group C, respectively. Postoperative sensitivity at 18 months was 16%, 12%, and 12% for Group A, Group B, and Group C, respectively.Conclusion:The clinical performance of total-etch and self-etch adhesive systems in NCCLs did not differ significantly with regard to the evaluated parameters – retention, marginal integrity, and postoperative sensitivity.

Clinical evaluation of performance of single unit polyetheretherketone crown restoration-a pilot study

Aim:The aim of this study was to evaluate the clinical performance and patient satisfaction of PEEK Crowns.Setting and Design:In-vivo longitudinal pilot study.Materials and Method:20 PEEK crowns were placed in 20 patients. 11 were placed in the maxilla and 9 were placed in the mandible. All procedural steps were performed by the same operator. The teeth were prepared with a chamfer finish line of 0.8 to 1 mm. The crowns fabricated were luted using resin cement. Using Modified Ryge's Criteria, the crowns were examined for anatomic form, marginal integrity, surface roughness, restoration staining, marginal discoloration and color match at a time interval of 1 week, 1 month, 3 months, 6 months, one year. Patient satisfaction was also evaluated at the same interval using a questionnaire.Statistical Analysis Used:The data collected was evaluated using fisher's exact test.Results:Based on modified Ryge's criteria, almost 90% of the crowns were rated satisfactory. Fracture was registered in only one crown. Slight chipping off was seen in two crowns. No significant difference was seen in any other factors assessed. Slight variation was seen in the periodontal status of 3 patients.Conclusion:Within the limitations of this study the following conclusions were drawn that the PEEK crowns demonstrated by the use of Modified Ryge's Criteria, its capability to produce quality prostheses that were rated satisfactory with a relatively low rate of fracture over the relative mean period of one year.

Practical Application of Assessment Principles in the Development of an Innovative Clinical Performance Evaluation in the Entrustable Professional Activity Era.

Educators have been challenged to create assessments that are competency-based and grounded in accepted standards such as the entrustable professional activities (EPAs). The clinical performance evaluation (CPE) is a commonly utilized assessment modality, which allows multiple evaluators to provide feedback on a learner's performance in the clinical workplace. In this paper, we describe the relevant principles that served as a guide as we developed a new CPE for medical students that fully incorporate EPAs. This may help ease the transition for other institutions looking to introduce a new student CPE.

Exploring Perspectives from Internal Medicine Clerkship Directors in the USA on Effective Narrative Evaluation: Results from the CDIM National Survey.

Clinical performance evaluations play a critical role in determining medical school clerkship grades. This study aimed to provide clarification from clerkship directors in internal medicine on what constitutes an effective and informative narrative description of student performance. In September 2016, the Clerkship Directors in Internal Medicine (CDIM) electronically administered its annual, voluntary, and confidential cross-sectional survey of its US membership. One section of the survey asked six questions regarding the helpful components of an effective narrative evaluation. Respondents were asked to rate the effectiveness of elements contained within narrative evaluations of students. Ninety-five CDIM members responded to the survey with an overall response rate of 74.2%. Descriptions of skills and behaviors were felt to be the most important, followed by a description of the overall synthetic or global assessment level of the student. Descriptions of personality and attitude were the next highest rated feature followed by adjectives describing performance. Length was felt to be the least important component. In free-text comments, several respondents indicated that direct observation of performance and specific examples of skills and behaviors are also desirable. Narrative evaluations of students that explicitly comment on skills, behaviors, and an overarching performance level of the learner are strongly preferred by clerkship directors. Direct observation of clinical performance and giving specific examples of such behaviors give evaluations even more importance. Faculty development on evaluation and assessment should include instruction on these narrative assessment characteristics.

Effects of a Virtual Reality Simulation and a Blended Simulation of Care for Pediatric Patient with Asthma

The purpose of this study was to examine the effects of a virtual reality simulation and a blended simulation on nursing care for children with asthma through an evaluation of critical thinking, problem-solving processes, and clinical performance in both education groups before and after the educational intervention. The participants were 48 nursing students. The experimental group (n=22) received a blended simulation, combining a virtual reality simulation and a high-fidelity simulation, while the control group (n=26) received only a virtual reality simulation. Data were collected from February 25 to 28, 2019 and analyzed using SPSS version 25 for Windows. The pretest and posttest results of each group showed statistically significant improvements in critical thinking, problem-solving processes, and clinical performance. In a comparison of the results of the two education groups, the only statistically significant difference was found for critical thinking. Simulation-based education in child nursing has continued to involve high-fidelity simulations that are currently run in many programs. However, incorporating a new type of blended simulation, combining a virtual reality simulation and a high-fidelity simulation, into the nursing curriculum may contribute to the further development of nursing education.

The Effect of Web-Based Preoperative and Postoperative Patient Care Education on Nursing Students: A Randomized Controlled Study.

This study examined the effect of Web-based preoperative and postoperative patient care education among undergraduate nursing students. This was an experimental, randomized controlled study. The study included 305 nursing students (experimental group: n = 155, control group: n = 150), who were assessed with the following instruments: the Preoperative and Postoperative Care Knowledge Test, Preoperative and Postoperative Care Skill Control List, Clinical Decision Making in Nursing Scale, and Nursing Student Clinical Performance Evaluation Scale. t Tests and χ tests were used to evaluate the data. There was no statistically significant difference between the students' posttest knowledge levels, clinical performance assessment, or clinical decision-making scores. The experimental group was found to perform the skills of "check patient's documents and prophylactic antibiotics when going to surgery" (χ = 4.88; P = .02), "controls the surgical safety checklist (before surgery) before going to surgery" (χ = 10.41; P = .00), and "observes surgical site/dressing (χ = 7.77; P = .00)" at a statistically significantly higher level. The education provided in the Web-based education was equivalent to that provided in traditional education. Thus, Web-based education appears to be a useful tool to educate student nurses in preoperative and postoperative patient care.

Sometimes being wrong is better than always being right

International Journal of Therapy and RehabilitationVol. 26, No. 8 EditorialSometimes being wrong is better than always being rightMassimiliano PolastriMassimiliano PolastriCorrespondence to: Massimiliano Polastri Email: E-mail Address: [email protected]Physiotherapist, Medical Department of Continuity of Care and Disability, Physical Medicine and Rehabilitation, St Orsola University Hospital, Bologna, ItalySearch for more papers by this authorMassimiliano PolastriPublished Online:3 Sep 2019https://doi.org/10.12968/ijtr.2019.0100AboutSectionsView articleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail View article References Eurostat. Healthcare personnel statistics – dentists, pharmacists and physiotherapists. 2016. https://tinyurl.com/y4n2bcr2 (accessed 3 August 2019) Google ScholarHall M, McFarlane LA, Mulholland S. Positive clinical placements: perspectives of students and clinical educators in rehabilitation medicine. Int J Ther Rehabil. 2012;19(10):549–556. https://doi.org/10.12968/ijtr.2012.19.10.549 Link, Google ScholarHammick M. Reading and reviewing the literature. Br J Ther Rehabil. 1994;1(1):43–46. https://doi.org/10.12968/bjtr.1994.1.1.43 Link, Google ScholarHassenkamp AM. Clinical reasoning: a student's nightmare. Br J Ther Rehabil. 1998;5(2):75–77. https://doi.org/10.12968/bjtr.1998.5.2.14218 Link, Google ScholarJacob T, Itzchak EB, Raz O. Stress among healthcare students – a cross disciplinary perspective. Physiother Theory Pract. 2013;29(5):401–412. https://doi.org/10.3109/09593985.2012.734011 Crossref, Google ScholarKirwan GW, Clark CR, Dalton M. Rating of physiotherapy student clinical performance: it is possible to gain assessor consistency? BMC Med Educ. 2019;19(1):32. https://doi.org/10.1186/s12909-019-1459-4 Crossref, Google ScholarThomson D, Patterson D, Chapman H et al.. Exploring the experiences and implementing strategies for physiotherapy students who perceive they have been bullied or harassed on clinical placements: participatory action research. Physiotherapy. 2017;103(1):73–80. https://doi.org/10.1016/j.physio.2015.12.003 Crossref, Google Scholar FiguresReferencesRelatedDetails 2 August 2019Volume 26Issue 8ISSN (online): 1759-779X Metrics History Published online 3 September 2019 Published in print 2 August 2019 Information© MA Healthcare LimitedPDF download

Non-invasive prenatal testing of fetal chromosomal aneuploidies: validation and clinical performance of the veracity test

IntroductionNon-Invasive Prenatal Testing (NIPT) for fetal aneuploidies using cell-free DNA (cfDNA) has been widely adopted in clinical practice due to its improved accuracy. A number of NIPT tests have been developed and validated. The purpose of this study is to evaluate the performance of the Veracity NIPT test for sex chromosome aneuploidy (SCA) detection in singleton pregnancies, autosomal aneuploidy detection in twin pregnancies and evaluation of Veracity clinical performance under routine NIPT conditions in a diverse cohort.MethodsBlinded retrospective study in singleton pregnancies (n = 305); blinded retrospective and prospective study in twin pregnancies (n = 306) and prospective evaluation of clinical performance in singleton and twin pregnancies (n = 10564).ResultsValidation study results for the detection of SCAs in singleton pregnancies exhibited 100% sensitivity and specificity and correctly classified 7 (45,X), 4 (47,XXY), 2 (47,XXX) and 1 (47,XYY) cases. Validation study results for autosomal aneuploidy detection in twin pregnancies exhibited 100% sensitivity and specificity and correctly classified 3 trisomy 21, 1 trisomy 18 and 1 trisomy 13 samples. Clinical performance evaluation of Veracity was performed in 10564 pregnancies with median gestational age of 13 weeks, median maternal age 35 years and median gestational weight of 64 kg. Based on confirmation feedback the PPV for trisomies 21, 18 and 13 was estimated at 100% (95% CI, 92–100%), 100% (95% CI, 69–100%) and 71% (95% CI, 29–96%), respectively. Estimated PPV for Monosomy X was 57% (95%CI, 18–90%), while the NPV for SCA detection was estimated at 100% (95% CI, 99.94–100%).ConclusionVeracity NIPT test is based on a very powerful, highly accurate methodology that can be safely applied in the clinical setting.

Evaluation of clinical performance and success of Fuji II and Fuji IX in restoring occlusal caries of primary molars over a one year follow up: A Randomized Clinical Trial

Introduction: Dental practitioners frequently face a notable challenge in selecting an ideal restorative material. Glass ionomer cement (GIC) has been a frequently used material as a substitute to amalgam in restoring primary dentition. Aim of the study: To clinically evaluate GC Fuji II LC (Light-Cured, Resin-Reinforced Glass Ionomer Restorative) and GC Fuji IX GP EXTRA (Packable Glass Ionomer) when used to restore occlusal caries in lower second primary molars. Materials and Methods: Seventy-six molars in 38 children were included in this study. Inclusion criteria included patients; (1) Free from any medical conditions. (2) Aged 5-7 years old. (3) Reported with bilateral restorable decayed second primary molars with simple occlusal decay. (4) Clinically; no signs of irreversible pulpitis. Split-mouth technique was used and a single operator performed all restorations. Examined restorative materials were randomly allocated to either side of the mouth. Cavities were prepared in the utmost conservative manner. Both Fuji II and Fuji IX were prepared according to manufacturers’ instructions. Clinical assessment was performed after 3, 6, 9 and 12 months according to United States Public Health Services (USPHS) evaluation criteria and rating system. Statistical Analyses included Wilcoxon signed-rank test as well as Friedman’s test followed by Dunn’s test. Results: Among the treated 38 subjects; there were18 boys (47.4%) and 20 girls (52.6%). Mean ± standard deviation values for age were 5.7 ± 0.8 years old with a minimum of 5 and a maximum of 7 years old. After 12 months, a statistically significant difference was noted between marginal adaptation, anatomic form, secondary caries and marginal discoloration scores in the two materials. Conclusions: Fuji II and Fuji IX showed comparable marginal adaptation. Fuji II restorations showed better results regarding anatomic form, secondary caries and marginal discoloration when compared to Fuji IX.

Glass Slippers and Glass Cliffs: Fitting In and Falling Off

A glass ceiling effect exists for women in male-dominated professions. Recent studies also show a glass-cliff effect where senior women can more easily fall from positions of leadership. Transplantation remains a male-dominated specialty. This study investigated gender and the perception of adverse clinical incidents in transplantation. Prospective randomised web-based survey involving five clinical scenarios presenting two versions of episodes with errors or mistakes, with either a male or female as a randomly named protagonist (Set1 and Set2). To address unconscious bias, the study was described as examining actions following clinical adverse incidents in transplantation. Each scenario was followed by 2 closed questions: (1) clinical performance rating and (2) selection of action required. Reasoning was invited (open-text comments). Responses were analyzed using quantitative and qualitative methods. One hundred ninety-one invitees responded; 134 completed questionnaires. There were no statistically significant differences (P > 0.05) in responses between sets for performance ratings or recommended actions. However, for "first solo laparoscopic surgery" scenario, there was some indication that "No Action" was more likely if surgeon was male (P = 0.056). Male responses rated female performance as significantly worse (P = 0.035) for the laboratory-based scenario. One hundred two participants provided open-text comments. Thematic analysis identified 7 themes. Acceptable levels of risk theme demonstrated engendered leadership beliefs, that is, when clinical judgment proved incorrect, males described as forceful but females as needing support. In cases where things went wrong, respondents were more likely to comment females should not have decided to proceed. While gender may no longer be an overt issue in perceived performance of senior staff in transplantation, respondents' use of language and their choice of words display elements of unconscious (covert) engendered views.

Clinical evaluation of performance, biocompatibility, and safety of vitamin E-bonded polysulfone membrane hemodialyzer compared to non-vitamin E-bonded hemodialyzer

The vitamin E-bonded polysulfone membrane hemodialyzer (ViE™-21) was evaluated in a clinical study for regulatory submission. Seventeen patients on hemodialysis were treated with conventional high-flux hemodialyzers for 2 weeks (Pre-ViE phase) and switched to the ViE-21 for 36 sessions (ViE phase) followed by an additional 2 weeks on conventional hemodialyzers (Post-ViE phase). Reduction ratios of urea, creatinine, beta-2-microglobulin, albumin, and ultrafiltration coefficients (KUF) were measured once during the Pre-ViE phase and twice during the ViE phase. Moreover, biocompatibility markers [leucocyte count, platelet count, and activated complement factor (C3a) levels] were evaluated pre-dialysis, 15 min after initiation, and post-dialysis. During the study, type and number of adverse events (AEs), and device malfunctions were recorded. ViE-21 reduction ratios and KUF were not noticeably different than those of conventional hemodialyzers. Fluctuations of leucocyte counts and C3a concentrations were similar using ViE-21 and conventional hemodialyzers; however, the platelet count fluctuation was lower in ViE-21 sessions. The frequency of episodes of hypotension occurring during the ViE phase was lower than that occurring during the Pre- and Post-ViE phases. In conclusion, this study provided performance and safety data of the ViE-21 for regulatory application. The data suggest that vitamin E-bonded hemodialyzers are beneficial in lowering platelet activation and frequency of intradialytic hypotension. Larger randomized controlled trials are needed to confirm these findings.