Assessment Committee Research Articles

Multicenter validation of the American Association for the Surgery of Trauma grading scale for acute cholecystitis.

The American Association for the Surgery of Trauma (AAST) patient assessment committee has created grading systems for emergency general surgery diseases to assist with clinical decision making and risk adjustment during research. Single-institution studies have validated the cholecystitis grading system as associated with patient outcomes. Our aim was to validate the grading system in a multi-institutional fashion and compare it with the Parkland grade and Tokyo Guidelines for acute cholecystitis. Patients presenting with acute cholecystitis to 1 of 8 institutions were enrolled. Discrete data to assign the AAST grade were collected. The Parkland grade was collected prospectively from the operative surgeon from four institutions. Parkland grade, Tokyo Guidelines, AAST grade, and the AAST preoperative grade (clinical and imaging subscales) were compared using linear and logistic regression to the need for surgical "bailout" (subtotal or fenestrated cholecystectomy, or cholecystostomy), conversion to open, surgical complications (bile leak, surgical site infection, bile duct injury), all complications, and operative time. Of 861 patients, 781 underwent cholecystectomy. Mean (SD) age was 51.1 (18.6), and 62.7% were female. There were six deaths. Median AAST grade was 2 (interquartile range [IQR], 1-2), and median Parkland grade was 3 (interquartile range [IQR], 2-4). Median AAST clinical and imaging grades were 2 (IQR, 2-2) and 1 (IQR, 0-1), respectively. Higher grades were associated with longer operative times, and worse outcomes although few were significant. The Parkland grade outperformed the AAST grade based on area under the receiver operating characteristic curve. The AAST cholecystitis grading schema has modest discriminatory power similar to the Tokyo Guidelines, but generally lower than the Parkland grade, and should be modified before widespread use. Diagnostic study, level IV.

Expert consensus on prenatal fluorescence in situ hybridization

Although non-invasive prenatal testing has been widely used, it has certain limitations. As the gold standard of prenatal diagnosis, G-banding karyotype analysis is time-consuming and laborious. Fluorescence in situ hybridization (FISH), as a method for detecting samples with non-radioactive signals, does not require cell culture and has a short turnover time, and can diagnose aneuploidies of chromosomes 13, 18, 21, X, Y with efficiency, which can solve the problems such as insufficient testing ability and long diagnosis period for karyotype analysis. To standardize the procedures of prenatal FISH assay and enhance laboratory quality management, the Expert Committee of the Prenatal Screening and Diagnosis Laboratory of the Clinical Test Center of the National Health Commission and the Inter-laboratory Quality Assessment Committee of the Neonatal Genetic and Metabolic Disease Screening Laboratory have formulated this consensus.

To Increase Diversity, Medicine Should Rethink USMLE Scores, Psychiatrists Say

To Increase Diversity, Medicine Should Rethink USMLE Scores, Psychiatrists Say

University of Minnesota Medical School.

University of Minnesota Medical School.

Medical University of South Carolina College of Medicine.

Medical University of South Carolina College of Medicine.

Dell Medical School at the University of Texas, Austin.

Dell Medical School at the University of Texas, Austin.

Queen's University Faculty of Health Sciences.

Queen's University Faculty of Health Sciences.

Florida International University Herbert Wertheim College of Medicine.

Florida International University Herbert Wertheim College of Medicine.

Drug-induced skin ulcers: A disproportionality analysis from the WHO pharmacovigilance database

Drug-induced skin ulcers: A disproportionality analysis from the WHO pharmacovigilance database

National hospital quality measures for surgical site infections in South Korea: a survey among 20 expert physicians

BackgroundSurgical site infection (SSI) is recognized as an important quality indicator for patient safety. In Korea, the use of prophylactic antibiotics for surgery is conducted as a national quality measures related to SSI prevention. The objective of the present study was to investigate physicians’ perceptions of hospital quality measures for SSI as well as identify obstacles that might hinder its implementation in South Korea.MethodOnline-based questionnaires were administered twice. Twenty physician experts who were members of the Healthcare Review and Assessment Committee that was constituted for the “Assessment of prophylactic use of antibiotics for surgery” participated in the study. The first survey comprised open-ended questions that were designed to elicit the physician who could hinder the implementation of SSI indicators. The second survey, which was developed on the basis of the initial survey’s results, consisted of 10 closed-ended questions about the feasibility of objective perception and the need for subjectivity, with regard to SSI.ResultsFrom among the 20 physicians, we collected data from 16 respondents in the first survey (response rate of 80%) and 15 respondents in the second survey (response rate of 75%).Thirty-one percent of the respondents supported hospital SSI evaluations, and 69% expressed objections. The obstacles that were perceived as being able to hinder hospital SSI evaluations pertained to difficulties in collecting data, unavailability of information, possibility of underreporting, and redundancy of the inquiry undertaken by the Korean National Healthcare-associated Infections Surveillance System-SSI. Physician experts provide significantly higher ratings for the clinical indicator, rate of readmission due to SSI, both in terms of feasibility and need, when evaluating the results of SSI prevention in hospitals.ConclusionThe results of this study show that physicians perceive the need for QI development of hospital SSI measurements to prevent nation-wide SSIs in Korea. However, the feasibility of hospital SSI measurements is low. To develop QIs of hospital SSIs using health insurance claims data, it is necessary to develop a methodology for claims data-based surveillance systems and a data collection system in order to increase the sensitivity and validity of post-operative SSI detection.

Study Design of the Nationwide Japanese Lead Extraction (J-LEX) Registry: Protocol for a Prospective, Multicenter, Open Registry.

BackgroundTransvenous lead extractions (TLEs) in Japan have grown to become the standard therapy since the approval of the laser extraction system in 2008. However, little is known about the current indications, methods, success rate, and acute complications in the real‐world setting.MethodsThe Japanese Lead EXtraction (J‐LEX) registry is a nationwide, multicenter, observational registry, performed by the Japanese Heart Rhythm Society (JHRS) in collaboration with the National Cerebral and Cardiovascular Center. This study is a nationwide registry ordered by the JHRS and its data are collected prospectively using the Research Electronic Data Capture (REDCap) system. The acute success rate at discharge and complications associated with TLEs will be collected in all cases. Based on the provided information, the annual incidence and predictive factors for the outcomes will be investigated by the Event Assessment Committee (EAC). This registry started in July 2018 and the number of participating medical institutions will be more than 50 hospitals and the target number of procedures will be 500‐1000 per year. We will also compare the results with other registries in foreign countries.ResultThe results of this study are currently under investigation.ConclusionThe J‐LEX registry will provide real‐world data regarding the results and complications of TLEs for the various types of indications, methods, and performing hospitals in Japan.

Faculty Perceptions of Research Assessment at Virginia Tech

In the spring of 2019, survey research was conducted at Virginia Polytechnic Institute and State University (Virginia Tech), a large, public, Carnegie-classified R1 institution in southwest Virginia, to determine faculty perceptions of research assessment as well as how and why they use researcher profiles and research impact indicators. The Faculty Senate Research Assessment Committee (FSRAC) reported the quantitative and qualitative results to the Virginia Tech Board of Visitors to demonstrate the need for systemic, political, and cultural change regarding how faculty are evaluated and rewarded at the university for their research and creative projects. The survey research and subsequent report started a gradual process to move the university to a more responsible, holistic, and inclusive research assessment environment. Key results from the survey, completed by close to 500 faculty from across the university, include: a.) the most frequently used researcher profile systems and the primary ways they are used (e.g., profiles are used most frequently for showcasing work, with results indicating that faculty prefer to use a combination of systems for this purpose); b.) the primary reasons faculty use certain research impact indicators (e.g., number of publications is frequently used but much more likely to be used for institutional reasons than personal or professional reasons); c.) faculty feel that research assessment is most fair at the department level and least fair at the university level; and d.) faculty do not feel positively towards their research being assessed for the allocation of university funding.

Teaming up to Teach Teamwork in an LIS Master’s Degree Program

Abstract
 Objective – Collaboration and working in teams are key aspects of all types of librarianship, but library and information studies (LIS) students often perceive teamwork and group work negatively. LIS schools have a responsibility to prepare graduates with the skills and experiences to be successful working in teams in the field. Through a grant from the university office of assessment, the assessment committee at the University of Rhode Island Graduate School of Library and Information Studies explored their department’s programmatic approach to teaching teamwork in the MLIS curriculum.
 Methods – This research followed a multi-method design including content analysis of syllabi, secondary analysis of student evaluation of teaching (SET) data, and interviews with alumni. Syllabi were analyzed for all semesters from fall 2010 to spring 2016 (n = 210), with 81 syllabi further analyzed for details about their team assignments. Some data was missing from the dataset of SETs purchased from the vendor, resulting in a dataset of 39 courses with SET data available. Interviews were conducted with a convenience sample of alumni about their experiences with teamwork in the LIS program and their view of how well the LIS curriculum prepared them for teamwork in their careers (n = 22).
 Results – Findings indicate that, although alumni remembered teamwork happening too often, it was required in just over one-third of courses in the sample period (fall 2010 to spring 2016), and teamwork accounted for about one-fifth of assignments in each of these courses. Alumni reported mostly positive experiences with teamwork, reflecting that teamwork assignments are necessary for the MLIS program because teamwork is a critical skill for librarianship. Three themes emerged from the findings: alumni perceived teamwork to be important for librarians and therefore for the MLIS program, despite this perception there is also a perception that the program has teamwork in too many courses, and questions remain about whether faculty perceive teaching teamwork as important and how to teach teamwork skills in the MLIS curriculum.
 Conclusions – Librarians need to be able to collaborate internally and externally, but assigning team projects does not guarantee students will develop the teamwork skills they need. An LIS program should be proactive in teaching skills in scheduling, time management, personal accountability, and peer evaluation to prepare students to be effective collaborators in their careers.

Are Your Quality Assessment and Assurance Documents Safe From Prying Eyes?

Are Your Quality Assessment and Assurance Documents Safe From Prying Eyes?

Phase Ib study of CPX-351 lower-intensity therapy (LIT) plus venetoclax as first-line treatment for patients with AML who are unfit for intensive chemotherapy (IC).

TPS7567 Background: CPX-351 (Vyxeos; daunorubicin and cytarabine liposome for injection) is approved by the FDA and EMA for the treatment of adults with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes. In a phase 3 study in patients (pts) aged 60-75 y with newly diagnosed high-risk/secondary AML who were fit for IC, CPX-351 significantly improved median survival versus 7+3 cytarabine/daunorubicin and had a comparable safety profile. However, it may not be appropriate to administer CPX-351 at the label dosage in pts unfit for IC. Venetoclax, a BCL-2 inhibitor, has clinical efficacy in combination with low-dose cytarabine in AML pts unfit for IC, and preclinical data suggest a rationale for combining CPX-351 and venetoclax. This study thus evaluates CPX-351 LIT in combination with venetoclax in AML pts unfit for IC. Methods: This is an open-label, multicenter, 2-part, phase 1b study (NCT04038437) to determine the maximum tolerated dose (MTD) and evaluate the safety, efficacy, and pharmacokinetics of CPX-351 LIT plus venetoclax. Key eligibility criteria are shown in the Table. In the dose-escalation phase (3+3 design), up to 24 pts will receive CPX-351 (dose levels: 20, 40, 60, and 75 units/m2) on Days 1 and 3 plus venetoclax 400 mg on Days 2-21 of each cycle to determine the MTD, with each dose escalation confirmed by a safety assessment committee. Pts who achieve complete or partial remission after 1 or 2 cycles may receive up to 4 similar cycles of CPX-351 plus venetoclax. In the expansion phase, an additional 20 pts will be treated at the MTD. All pts are assessed for response by morphology and minimal residual disease testing, and are monitored for safety (until 1 month after end of treatment) and survival (up to 1 year after start of treatment). The study is ongoing and actively enrolling pts. Clinical trial information: NCT04038437 . [Table: see text]

A probabilistic seismic hazard assessment for Wylfa Newydd, a new nuclear site in the United Kingdom

This study presents the probabilistic seismic hazard assessment (PSHA) for a nuclear site in the UK, Wylfa Newydd. The PSHA was defined at a bedrock horizon with shear wave velocity of 3000 m/s and developed to capture the centre, body and range of the technical defensible interpretations. Although not a formal SSHAC (Senior Seismic Hazard Assessment Committee) process, the PSHA met all the SSHAC Level 2 requirements with some aspects of SSHAC Level 3 and 4. Two base source models were developed: SM1 mainly driven by the observed seismicity and SM2 guided by the geology and tectonics. To capture epistemic uncertainty, variations of boundaries were included in the logic tree, resulting in five different models. Based on the selection discussed by Villani et al. (Bull Seismol Soc Am 109(4):1378–1400, 2019), four empirical models adjusted to the hard rock site conditions of Wylfa Newydd and a site-specific stochastic GMPE, developed within this project, were adopted in the logic tree for the median prediction. For all GMPEs a logic tree for the single-station sigma model was adopted. The PSHA resulted in a mean peak ground acceleration value for annual probability of exceedance of 10−4 of 0.192 g. The comparison of the mean 10−4 uniform hazard spectrum with the traditional piecewise linear design spectrum showed significant conservatism up to 20 Hz and underestimation at higher frequencies. To overcome this limitation, a performance-based design spectrum, following US practice (ASCE/SEI 43-05), was therefore recommended; this marks a significant difference to the traditional UK design practice.

SAGES TAVAC safety and efficacy analysis confocal laser endomicroscopy.

Confocal laser endomicroscopy (CLE) is a novel endoscopic adjunct that allows real-time in vivo histological examination of mucosal surfaces. By using intravenous or topical fluorescent agents, CLE highlights certain mucosal elements that facilitate an optical biopsy in real time. CLE technology has been used in different organ systems including the gastrointestinal tract. There has been numerous studies evaluating this technology in gastrointestinal endoscopy, our aim was to evaluate the safety, value, and efficacy of this technology in the gastrointestinal tract. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Technology and Value Assessment Committee (TAVAC) performed a PubMed/Medline database search of clinical studies involving CLE in May of 2018. The literature search used combinations of the keywords: confocal laser endomicroscopy, pCLE, Cellvizio, in vivo microscopy, optical histology, advanced endoscopic imaging, and optical diagnosis. Bibliographies of key references were searched for relevant studies not covered by the PubMed search. Case reports and small case series were excluded. The manufacturer's website was also used to identify key references. The United States Food and Drug Administration (U.S. FDA) Manufacturer And User facility and Device Experience (MAUDE) database was searched for reports regarding the device malfunction or injuries. The technology offers an excellent safety profile with rare adverse events related to the use of fluorescent agents. It has been shown to increase the detection of dysplastic Barrett's esophagus, gastric intraepithelial neoplasia/early gastric cancer, and dysplasia associated with inflammatory bowel disease when compared to standard screening protocols. It also aids in the differentiation and classification of colorectal polyps, indeterminate biliary strictures, and pancreatic cystic lesions. CLE has an excellent safety profile. CLE can increase the diagnostic accuracy in a number of gastrointestinal pathologies.

Drug provision and health technology assessment in France

The article presents the description of structural, organizational and methodological issues of health technology assessment (HTA) of French drugs as well as the state-reimbursable list of drugs. The HTA is conducted by an independent public body – French National Authority for Health (HAS). HAS evaluates medical products, procedures, services and technologies from a medical and economic points of view to make cost recovery decisions. HAS consists of two committees providing HTA: Transparency Committee and the Economic and Public Health Assessment Committee. Thus, the French HTA consists of two separate components within the same agency. The result of HAS evaluation of a drug is a conclusion on the level of clinical value and clinical added value, as well as the methodological quality of the studies and the size of the target patient population. Based on the evaluation results, HAS gives recommendations for the National Union of Health Insurance Funds, the Economic Committee for Healthcare Products and Ministry of Health and publishes its opinion on the HAS website. HAS decisions are of a recommendatory nature – the final decision whether to include the drug in reimbursement lists are made by the Ministry of Health and published in the Official Journal of French republic.

Development of the Constructive Alignment Evaluation Instrument for Lecturers of Teachers Education Institutes

This study was conducted to build the constructs and sub-constructs for the Constructive Alignment Evaluation Instrument (CAEI) for lecturers of Teachers Education Institutes (TEIs) based on the experts' views. Interviews involving a total of five experts from TEIs in Malaysia were conducted using purposive sampling. The experts involved were Chairman of the TEI Assessment Committee, Internal Examiner Expert, Chairman of the MQA Committee, Chairman of the ISO Secretariat and Assessment Coordinator of the Department. The interview data was analyzed thematically using Nvivo software. Based on the interview, it was found that there were certain shortcomings to be addressed in the implementation of constructive alignment among TEIs’ lecturers. The constructs driven from the interview were knowledge and practice, comprising a total of six sub-constructs, namely, Learning Outcomes, Teaching and Learning Activities, Assessment of Assignment, Evaluation and Grading, Learning Context and Students Learning Time. The sub-construct of learning outcomes consists of four elements; Programme Educational Objectives, Programme Learning Outcomes, Teaching Taxonomy, and Course Learning Outcomes. The sub-construct of Teaching and Learning Activities is also divided into four elements; Teaching and Learning Planning, Mapping of Knowledge Type, Interactive Teaching and Class Management. Meanwhile, the subconstruct of assessment assignment contains elements such as Formative and Summative, Authenticating, Converging and Diverging Assessments and Bloom's Taxonomy. As for Students Learning Time, its sub-construct includes elements of Implementation of Learning Hours, Credit and Learning Load. The sub-construct of Evaluation and Grading contains elements of Validity and Reliability, Criterion References, Norm References and Evaluation Based on Learning Outcomes. Finally, the sub-construct of Learning Context is divided into five elements, Metacognitive Control, Reflective Learning, Teaching Quality and Student Activity, Formative Feedback and Motivational Approach. Based on the results obtained, the constructive alignment evaluation instrument should include all the constructs and sub-constructs identified.

Mechanism of Action of TiO2: Recommendations to Reduce Uncertainties Related to Carcinogenic Potential.

The Risk Assessment Committee of the European Chemicals Agency issued an opinion on classifying titanium dioxide (TiO2) as a suspected human carcinogen upon inhalation. Recent animal studies indicate that TiO2 may be carcinogenic through the oral route. There is considerable uncertainty on the carcinogenicity of TiO2, which may be decreased if its mechanism of action becomes clearer. Here we consider adverse outcome pathways and present the available information on each of the key events (KEs). Inhalation exposure to TiO2 can induce lung tumors in rats via a mechanism that is also applicable to other poorly soluble, low-toxicity particles. To reduce uncertainties regarding human relevance, we recommend gathering information on earlier KEs such as oxidative stress in humans. For oral exposure, insufficient information is available to conclude whether TiO2 can induce intestinal tumors. An oral carcinogenicity study with well-characterized (food-grade) TiO2 is needed, including an assessment of toxicokinetics and early KEs.