Definitive Assessment Research Articles

A preliminary study of the clinical significance of folate receptor-positive circulating tumor cell in the management of hepatobiliary-pancreatic cancers.

BackgroundHepatobiliary-pancreatic cancers (HBPs) are highly lethal, partly because of their usually late diagnosis. This multi-center, observational study aimed to explore the clinical significance of folate receptor-positive circulating tumor cell (FR+CTC) as a liquid biopsy approach in the differential diagnosis and management of HBPs.MethodsWe recruited 119 patients suspicious for HBPs and 60 cancer-free healthy individuals in the present study. Patients without definitive pathological assessment or without pre-operative FR+CTC analysis were excluded. FR+CTC was tested prior to surgery or tissue biopsy using the CytoploRare® Detection Kit. Serum biomarkers, including CA 125, CA 19-9, and CEA, were tested in selected patients. Post-operative FR+CTC analysis was also performed in a subset of the patients receiving surgical resection.ResultsWith 8.65 FU/3 mL as the cut-off value, the sensitivity and specificity of FR+CTC in differential diagnosis were 98.1% and 79.1%, respectively. The detection rate of FR+CTC was superior to conventional serum biomarkers (CA 19-9 > CA 125 > CEA). For the 16patients with matched post-operative FR+CTC analysis, FR+CTC levels significantly reduced after surgery (P=0.0084).ConclusionsOur results demonstrated that FR+CTC analysis could be an efficacious non-invasive biomarker in differential diagnosis and surveillance of HBPs, though further investigation with a larger sample size is required.

Endoscopic Recognition and Management Strategies for Malignant Colorectal Polyps: Recommendations of the US Multi-Society Task Force on Colorectal Cancer.

Endoscopic Recognition and Management Strategies for Malignant Colorectal Polyps: Recommendations of the US Multi-Society Task Force on Colorectal Cancer.

Effect of Intensive Urate Lowering With Combined Verinurad and Febuxostat on Albuminuria in Patients With Type 2 Diabetes: A Randomized Trial

Hyperuricemia has been implicated in the development and progression of chronic kidney disease. Verinurad is a novel, potent, specific urate reabsorption inhibitor. We evaluated the effects on albuminuria of intensive urate-lowering therapy with verinurad combined with the xanthine oxidase inhibitor febuxostat in patients with hyperuricemia and type 2 diabetes mellitus (T2DM). Phase 2, multicenter, prospective, randomized, double-blind, parallel-group, placebo-controlled trial. Patients 18 years or older with hyperuricemia, albuminuria, and T2DM. Patients randomly assigned 1:1 to verinurad (9mg) plus febuxostat (80mg) or matched placebo once daily for 24 weeks. The primary end point was change in urinary albumin-creatinine ratio (UACR) from baseline after 12 weeks' treatment. Secondary end points included safety and tolerability and effect on glomerular filtration. 60 patients were enrolled (n=32, verinurad and febuxostat; n=28, placebo). UACRs after treatment with verinurad plus febuxostat were lower than after placebo at 1, 12, and 24 weeks:-38.6% (90% CI,-60.9% to-3.6%),-39.4% (90% CI,-61.8% to-3.8%), and-49.3% (90% CI,-68.2% to-19.0%), respectively. Serum urate levels after treatment with verinurad plus febuxostat were 59.6% and 63.7% lower than after placebo at 12 and 24 weeks, respectively. No clinically meaningful changes were observed in estimated glomerular filtration rate or serum creatinine or serum cystatin C concentrations. Verinurad plus febuxostat was well tolerated. Sample size and study duration were insufficient to evaluate definitive effects of verinurad plus febuxostat on UACR and glomerular filtration. Generalizability was limited by exclusion of patients with stages 4 and 5 chronic kidney disease. Verinurad plus febuxostat reduced albuminuria and lowered serum urate concentrations in patients with T2DM, albuminuria, and hyperuricemia. Definitive assessment of their combined impact on preservation of kidney function awaits larger clinical studies. This study was supported by AstraZeneca. Registered at ClinicalTrials.gov with study number NCT03118739.

Current Cognition Tests, Potential Virtual Reality Applications, and Serious Games in Cognitive Assessment and Non-Pharmacological Therapy for Neurocognitive Disorders.

As the global population ages, the incidence of major neurocognitive disorders (major NCDs), such as the most common geriatric major NCD, Alzheimer’s disease (AD), has grown. Thus, the need for more definitive cognitive assessment or even effective non-pharmacological intervention for age-related NCDs is becoming more and more pressing given that no definitive diagnostics or efficacious therapeutics are currently unavailable for them. We evaluate the current state of the art of cognitive assessment for major NCDs, and then briefly glance ahead at potential application of virtual reality (VR) technologies in major NCD assessment and in cognition training of visuospatial reasoning in a 3D environment, as well as in the alleviation of depression and other symptoms of cognitive disorders. We believe that VR-based technologies have tremendous potentials in cognitive assessment and non-pharmacological therapy for major NCDs.

Valor de la evaluación intraoperatoria del margen quirúrgico para el diagnóstico de margen afecto en cirugía conservadora del cáncer de mama

IntroductionA positive margin in breast-conserving surgery is an important prognostic factor. The aim of this study was to determine the influence of our protocol for the intraoperative assessment of the surgical specimen on the frequency of margin involvement (MI). We also studied the accuracy of our protocol as a diagnostic test of MI. MethodsWe included patients treated with breast-conserving surgery for infiltrating ductal carcinoma in a breast cancer referral centre between 2004 and 2015. Intraoperative assessment consisted of macroscopic inspection of the specimen by a pathologist. MI was defined by ink on tumor. ResultsA total of 799 patients were included. In 312 patients (39%), the margin was considered involved or in danger of involvement and intraoperative widening was performed. MI was confirmed by definitive assessment in 123 of these patients and clear margins were confirmed in 189 patients. In 487 patients, the initial margin was considered disease-free and margin enlargement was not performed. In 459 of these patients (94.2%) subsequent analysis confirmed disease-free margins. In 28 patients, intraoperative assessment suggested disease-free margins but subsequent analysis revealed MI. Without intraoperative margin assessment, the rate of definitive MI would have been 18.9% (151 patients out of 799). Due to intraoperative widening, the rate of definitive MI in infiltrating tumours was decreased from 18.9 to 5.7%. Definitive MI was found in 46 patients, 28 in the group with disease-free margins at the intraoperative assessment and 18 in the group with MI at the intraoperative assessment. The sensitivity of the procedure was 0.81 and specificity was 0.71. The positive predictive value was 0.39 and the negative predictive value was 0.94. ConclusionThe application of our protocol for the intraoperative assessment of infiltrating tumors revealed an MI rate of 5.7%. Moreover, as a diagnostic test, the procedure showed high negative predictive value, allowing selection of patients not requiring margin enlargement in a second intervention.

Alain Robbe-Grillet and Nathalie Sarraute: in the Labyrinths of Metaphors

The article deals with aesthetic and stylistic particularities of the works by A. Robbe-Grillet and N. Sarraute, two famous writers and theorists of the “Nouveau Roman”. This literary movement continues to provoke debates about its interpretation and definitive assessment among foreign and national scientists, indicating the timeliness of the work. The research is based on their criticism and fiction published in the late 1950s – early 1960s. Analysing the literary context and the aesthetic views of the writers allows us to explain causes of their disagreements, to discover similarities and differences between their creative methods. Interpreting the works in the light of the image of labyrinth gives the opportunity to outline the main features of the poetics of Robbe-Grillet and Sarraute from a new angle. The use of metaphor is one of the characteristics that unites the literary practice of these authors. The concept of labyrinth has a number of philosophical and cultural senses, and its consideration is fruitful in order to study the individuality of the “nouveaux romanciers” literary world. The meaning of the image of labyrinth in the texts of “Dans le labyrinthe” and “Le Planétarium” is treated with comparative and hermeneutic methods, definitive and contextual analysis. The labyrinth defines the logic of creating the whole novel of Robbe-Grillet; it is involved in the description of interior and the image-bearing structure of Sarraute’s work. In addition, the metaphor is the basis of the stylistic manner of both authors, in spite of its different functioning in the considered works. As opposed to rudimentary and stereotypical story and characters, the metaphor in their texts serves to represent psychic activities of any person. Interpreting subconscious processes becomes the central content of the French writers’ works. The “nouveaux romanciers” assign to a reader a significant role in expounding their texts, that triggers self-knowledge, as well as philosophical reflections. The study may be of interest for experts in philology, science of culture and philosophy. Keywords: “Nouveau Roman”, metaphor, subconscious, image, interpretation, story, character

Motives for non-adherence to colonoscopy advice after a positive colorectal cancer screening test result: a qualitative study

Setting Participants with a positive faecal immunochemical test (FIT) in screening programs for colorectal cancer (CRC) have a high risk for colorectal cancer and advanced adenomas. They are therefore recommended follow-up by colonoscopy. However, more than ten percent of positively screened persons do not adhere to this advice. Objective To investigate FIT-positive individuals’ motives for non-adherence to colonoscopy advice in the Dutch CRC screening program. Subjects Non-adherent FIT-positive participants of the Dutch CRC screening program. Design We conducted semi structured in-depth interviews with 17 persons who did not undergo colonoscopy within 6 months after a positive FIT. Interviews were undertaken face-to-face and data were analysed thematically with open coding and constant comparison. Results All participants had multifactorial motives for non-adherence. A preference for more personalised care was described with the following themes: aversion against the design of the screening program, expectations of personalised care, emotions associated with experiences of impersonal care and a desire for counselling where options other than colonoscopy could be discussed. Furthermore, intrinsic motives were: having a perception of low risk for CRC (described by all participants), aversion and fear of colonoscopy, distrust, reluctant attitude to the treatment of cancer and cancer fatalism. Extrinsic motives were: having other health issues or priorities, practical barriers, advice from a general practitioner (GP) and financial reasons. Conclusion Personalised screening counselling might have helped to improve the interviewees’ experiences with the screening program as well as their knowledge on CRC and CRC screening. Future studies should explore whether personalised screening counselling also has potential to increase adherence rates. Key points Participants with a positive FIT in two-step colorectal cancer (CRC) screening programs are at high risk for colorectal cancer and advanced adenomas. Non-adherence after an unfavourable screening result happens in all CRC programs worldwide with the consequence that many of the participants do not undergo colonoscopy for the definitive assessment of the presence of colorectal cancer. Little qualitative research has been done to study the reasons why individuals participate in the first step of the screening but not in the second step. We found a preference for more personalised care, which was not reported in previous literature on this subject. Furthermore, intrinsic factors, such as a low risk perception and distrust, and extrinsic factors, such as the presence of other health issues and GP advice, may also play a role in non-adherence. A person-centred approach in the form of a screening counselling session may be beneficial for this group of CRC screening participants.

Definition and Prospective Assessment of Functional Recovery After Liver Transplantation: A New Objective Consensus-Based Metric for Safe Discharge.

Standardized discharge criteria are critical to reduce premature discharge and avoid unnecessary hospital stays. No such criteria exist for patients undergoing liver transplantation (LT). To achieve a consensus-based checklist of criteria for safe patient discharge after LT, this mixed-method study included the following: a systematic literature review and expert discussion to draft a first checklist of post-LT discharge criteria, defining patient recovery and indications for hospital discharge (functional recovery); an exploratory online electronic Delphi (e-Delphi) study; a single-center pilot study to test checklist feasibility; and a final e-Delphi study with an extended interdisciplinary expert panel to validate the final checklist. The first round provided a 10-point discharge checklist with 5 patient-centered items derived from discharge criteria after liver surgery and 5 graft-centered items derived from expert discussion. The restricted panel (9 experts) e-Delphi provided 100% consensus after the second round, with slight modifications to the criteria. During the pilot study, 19 of 45 (42.2%) patients included fulfilled the complete checklist (100% of 10 items) after median (IQR) 16 (8-21) days (functional recovery) and a length of stay of 20 (9-24) days. The item with the lowest completion rate was minimum serum tacrolimus level in the target on 2 consecutive blood samples (n = 21; 47%), achieved at 13 (9-15) days. The extended panel (66 experts) e-Delphi provided 95%-98% consensus after the third round, with slight modifications of the criteria. This study provided substantial consensus on discharge criteria after LT. We anticipate that these criteria will be useful in clinical practice to guide patient discharge and increase the comparability of results between future studies.

Geometry definition and performance assessment of Tesla turbines for ORC

The Tesla turbine - also known as friction, viscous or bladeless turbine - is a peculiar expander, which generates power through viscous entrainment. In the last years, it has gained a renewed appeal due to the rising of distributed power generation applications. Indeed, this expander is not suitable to large size power generation, but it could become a breakthrough technology in the low power ranges, due to its characteristics of low cost and reliability. The current study presents a design approach to the Tesla turbine, applied to organic working fluids (R1233zd(E), R245fa, R1234yf, n-Hexane). Three fundamental geometric parameters are identified (rotor channel width/inlet diameter ratio, rotor outlet/inlet diameter ratio, throat width ratio) and their effects on the performance are analysed. The geometry of the turbine has been defined and the assessment of the performance potential is run, applying a 2D code for the viscous flow solution, considering real compressible fluid properties. For all the investigated working fluids, an efficiency higher than 60% has been achieved, with the defined geometry, under suitable thermo fluid-dynamic conditions.

Choosing pasture maps: An assessment of pasture land classification definitions and a case study of Brazil

Pasture land occupies extensive areas and is increasingly of interest for sustainable intensification, land use diversification, greenhouse gas emission mitigation, and bioenergy expansion. Accurate maps of pasture and other managed land covers are needed for monitoring, intercomparison, assessing potential uses, and planning. Yet, land maps can be generated from different types of classification datasets – i.e. as a land use or land cover type – as well as different sources. In this study our aim was to assess and compare land use and land cover definitions for pasture, and examine variability in the resulting pasture land classification maps. First, we conducted a review of pasture definitions in commonly used mapping databases. We then performed a case study involving Brazil, a dominant global producer of pasture-based livestock. Six geospatial databases were harmonized and compared to each other and to MODIS land cover for Brazil including the Cerrado and Amazon biomes, which are internationally recognized for their ecological value. Total pasture area estimates for Brazil ranged by a factor greater than four, from about 430,000 km2 to over 1.7 million km2. Our analysis showed high variability in pasture land maps depending on the definitions, methods and underlying datasets used to generate them. The results are illustrative of a symptomatic problem for all manage land datasets, demonstrating the need for land categories studies and geospatial data resources that fully define land terms and describe measurable management attributes. Additionally, the suitability of individual geospatial datasets for different types of land mapping must be better described and reported. These recommendations would help bring more consistency in the consideration of managed lands in research, reporting, and policy development, as demonstrated here for pasture land using six case study datasets from multiple sources.

REAL DOUBLE IMAGES VS REAL DOUBLE OBJECTS: OBJECTS NEAR THE PANORAMIC CENTER OF ROTATION PATH PRESENT CONFUSING IMAGING RESULTS

<h3>Background</h3> A 57-year-old male presented for routine dental care without symptoms. Panoramic imaging depicted a large, laminated radiopacity inferior to the right posterior mandible. A similar image was noted on the contralateral side with a blurred, mirrored orientation. A smaller radiopacity was seen medial to the left larger radiopacity; however, no similar radiopacity was seen on the right. A firm, palpable mass was detected along the right lateral neck clinically, with nothing noted on the left side. <h3>Objective</h3> The aim of this study was to explain the potentially confusing imaging results of a sialolith on the panoramic center of rotation path by reviewing panoramic imaging acquisition principles and comparison with cone beam computed tomography (CBCT) results. <h3>Materials and Methods</h3> Panoramic images and a CBCT volume were acquired for implant planning purposes and for definitive assessment of the initial differential diagnosis based on the panoramic images. <h3>Results</h3> Multiple unilateral vs bilateral sialoliths, tonsilloliths, and calcified lymph nodes were considered after initial panoramic acquisition. CBCT confirmed a large sialolith on the right, with an additional, smaller sialolith in a slightly more anterior location on the left. Because of lack of symptoms, no treatment was recommended, and only periodic follow-up was suggested. <h3>Discussion</h3> Although the formation of real single, real double, and ghost images may be easy to understand, distinguishing among these entities sometimes may be challenging. The double-image area is not confined solely to the midline, and the area expands laterally, depending on the diverging path of the center of rotation. A large sialolith on the right side positioned in the lateroposterior aspect of the double-image area yielded a double image on the contralateral side with a mirrored orientation and similar proportions. The left sialolith yielded only a real single image due to the small difference of the anterior position. Objects just anterior to the double image area, but outside the focal trough, may have a similar blurred appearance to a real double image projected from the contralateral side. Recognizing the wider region of the double-image area, as well as proper patient positioning, is important for accurate diagnosis of real double images vs real double objects.

A simplified diagnostic work-up for the detection of gestational diabetes mellitus in low resources settings: achievements and challenges

PurposeModern strategies for the screening and diagnosis of Gestational Diabetes Mellitus (GDM) rely on universal Oral Glucose Tolerance Test (OGTT). However, they are unsustainable in low-income countries. In this study, we aimed at assessing the feasibility of a simplified diagnostic policy.MethodsThe study took place in an urban referral hospital in Freetown, Sierra Leone. During an 11-month period, pregnant women were offered capillary blood test for glucose assessment. They could be screened at any time during pregnancy. GDM was diagnosed if fasting glucose was ≥ 92 mg/dl or if the OGTT was positive. The latter was prescribed only to women presenting after 24 weeks’ gestation with at least one risk factor for GDM and fasting capillary glucose between 85 and 91 mg/dl. A definitive diagnosis required confirmation to this aim, women with values above the thresholds were invited to refer the next working day for repeating the test after fasting overnight.ResultsOverall, 7827 women were referred for screening, of whom 6872 (87%) underwent at least one capillary glucose assessment. However, 895 of those who had a positive test did not return for confirmation. Overall, a definite assessment could be done in 5799 subjects corresponding to 76% (95% CI 75–77%) of those eligible. GDM was diagnosed in 128 women (1.9%, 95% CI 1.6–2.2%). Based on an expected confirmation rate of 22% (calculated from those who referred for confirmation) in the 895 women who did not come back, one could infer that GDM would have been diagnosed in additional 197 women, raising the prevalence to 4.7% (95% CI 4.2–5.3%).ConclusionThree quarters of subjects could be assessed with our approach. Data also suggest that GDM is not rare even if identification of affected cases remains challenging.

Developmental differences in preschoolers’ definition assessment and production

Children are able to assess the quality of information presented to them, most notably in the domains of causal explanations and arguments. However, children are also presented with another form of verbal information—definitions. Very little empirical work has investigated how children assess and produce definitions. Two experiments explored preschoolers’ comprehension and production of definitions. In Experiment 1, a selective trust paradigm was used to assess 3-year-olds’ (n = 28) and 5-year-olds’ (n = 28) endorsements of informative and uninformative definitions. Participants were provided with two informants: one who always provided a circular definition (e.g., “Silly means when you are silly”) and one who always provided a noncircular definition (e.g., “Silly means when you are goofy”). The 5-year-olds endorsed noncircular definitions over circular definitions for both frequent and infrequent words, but they chose to learn only from informants who provided information about infrequent words. The 3-year-olds, on the other hand, did not systematically endorse either definition type. In Experiment 2, new groups of 3-year-olds (n = 25) and 5-year-olds (n = 24) were asked to provide definitions, and their responses were coded for correctness and circularity. Results demonstrated that 5-year-olds provided more definitions than 3-year-olds. In addition, 5-year-olds provided more noncircular definitions than 3-year-olds for infrequent words but not for frequent words. Together, the results from Experiments 1 and 2 suggest that children’s understanding of definitions emerges during the preschool period. This work presents an important first step in addressing an understudied facet of lexical development.

Comparison of modular and traditional UK housing construction: a bibliometric analysis

PurposeHousing completions in the UK have fallen to 125,000 annually, while government targets have risen to 300,000. This dramatic shortfall raises concerns as to whether current traditional construction approaches remain appropriate. This study aims to compare the traditional approach with modular construction, with a view to assessing whether a shift in construction systems offers the potential to alleviate the UK's domestic housing crisis.Design/methodology/approachA comprehensive interpretivist review of the available relevant literature is undertaken on construction methods within the UK; advantages and disadvantages. A bibliometric analysis is conducted to extract trends and findings relevant to the comparison at hand. The database is Web of Science; the analysis software is the VOS viewer.FindingsThe research illustrates that the UK housing market is in a state of crisis. A toxic combination of a rising UK population combined falling rates of housing delivery has resulted in an ever-widening housing supply gap. The construction industry’s capacity to meet this observed dearth in supply is further exacerbated by a number of chronic factors such as: falling participation in the construction sector workforce; lowering skill levels; reducing profitability; time to delivery pressures; and cost blow-outs.Originality/valueWhile much information on the various construction methods are available, including comparative material, this study is the first to assemble the various comparative parameters regarding traditional and modular UK residential construction in one place. Thus, this study provides a definitive assessment of the relative advantages and disadvantages of these forms of construction.

Minimal clinically important differences after subpectoral biceps tenodesis: definition and retrospective assessment of predictive factors

Minimal clinically important differences (MCIDs) at 1 year after subpectoral biceps tenodesis are unknown for the American Shoulder and Elbow Surgeons (ASES) scale, Subjective Shoulder Value (SSV), and visual analog scale (VAS) for pain. Our objectives were to determine MCIDs for these measures at 1 year after biceps tenodesis and to identify preoperative factors that predict attainment of MCIDs. We included 52 patients who underwent arthroscopic débridement, decompression, and mini-open biceps tenodesis from 2016-2018. We analyzed age, sex, body mass index value, arm dominance, diagnosis, range of shoulder motion, and preoperative and 1-year postoperative ASES, SSV, and VAS scores. MCIDs were calculated using a distribution-based method of one-half the standard deviation. Preoperative thresholds predictive of MCIDs were calculated with univariate logistic regression. Multiple logistic regression was used to determine factors that predict MCIDs. Significance was set at a 2-tailed P value of <.05. MCIDs for the ASES, SSV, and VAS were 13, 12, and 1.6 points, respectively. Preoperative ASES score <59 predicted MCID on the ASES (P = .03); VAS score >3 predicted MCID on the VAS (P < .01); external shoulder rotation >40° predicted MCID on the SSV (P = .02); and age >41 years predicted MCID on the VAS (P = .02). At 1 year after débridement, decompression, and biceps tenodesis, MCIDs were 13, 12, and 1.6 points for the ASES, SSV, and VAS, respectively. Patients most likely to attain MCIDs were those aged >41 years, those with the most preoperative pain, and those with the poorest preoperative shoulder function.

Assessment of a demonstrator repository for individual clinical trial data built upon DSpace

Background: Given the increasing number and heterogeneity of data repositories, an improvement and harmonisation of practice within repositories for clinical trial data is urgently needed. The objective of the study was to develop and evaluate a demonstrator repository, using a widely used repository system (DSpace), and then explore its suitability for providing access to individual participant data (IPD) from clinical research. Methods: After a study of the available options, DSpace (version 6.3) was selected as the software for developing a demonstrator implementation of a repository for clinical trial data. In total, 19 quality criteria were defined, using previous work assessing clinical data repositories as a guide, and the demonstrator implementation was then assessed with respect to those criteria. Results: Generally, the performance of the DSpace demonstrator repository in supporting sensitive personal data such as that from clinical trials was strong, with 14 requirements demonstrated (74%), including the necessary support for metadata and identifiers. Two requirements could not be demonstrated (the ability to include de-identification tools and the availabiltiy of a self-attestation system) and three requirements were only partially demonstrated (ability to provide links to de-identification tools and requirements, incorporation of a data transfer agreement in system workflow, and capability to offer managed access through application on a case by case basis). Conclusions: Technically, the system was able to support most of the pre-defined requirements, though there are areas where support could be improved. Of course, in a productive repository, appropriate policies and procedures would be needed to direct the use of the available technical features. A technical evaluation should therefore be seen as indicating a system’s potential, rather than being a definite assessment of its suitability. DSpace clearly has considerable potential in this context and appears a suitable base for further exploration of the issues around storing sensitive data.

Assessment of a demonstrator repository for individual clinical trial data built upon DSpace

Background: Given the increasing number and heterogeneity of data repositories, an improvement and harmonisation of practice within repositories for clinical trial data is urgently needed. The objective of the study was to develop and evaluate a demonstrator repository, using a widely used repository system (DSpace), and then explore its suitability for providing access to individual participant data (IPD) from clinical research. Methods: After a study of the available options, DSpace (version 6.3) was selected as the software for developing a demonstrator implementation of a repository for clinical trial data. In total, 19 quality criteria were defined, using previous work assessing clinical data repositories as a guide, and the demonstrator implementation was then assessed with respect to those criteria. Results: Generally, the performance of the DSpace demonstrator repository in supporting sensitive personal data such as that from clinical trials was strong, with 14 requirements demonstrated (74%), including the necessary support for metadata and identifiers. Two requirements could not be demonstrated (the ability to include de-identification tools and the availabiltiy of a self-attestation system) and three requirements were only partially demonstrated (ability to provide links to de-identification tools and requirements, incorporation of a data transfer agreement in system workflow, and capability to offer managed access through application on a case by case basis). Conclusions: Technically, the system was able to support most of the pre-defined requirements, though there are areas where support could be improved. Of course, in a productive repository, appropriate policies and procedures would be needed to direct the use of the available technical features. A technical evaluation should therefore be seen as indicating a system’s potential, rather than being a definite assessment of its suitability. DSpace clearly has considerable potential in this context and appears a suitable base for further exploration of the issues around storing sensitive data.

A Systematic Review of the Prevalence and Diagnostic Workup of PIK3CA Mutations in HR+/HER2- Metastatic Breast Cancer.

PIK3CA mutation frequency varies among breast cancer (BC) subtypes. Recent evidence suggests combination therapy with the PI3K inhibitor (PI3Ki) alpelisib and endocrine therapy (ET) improves response rates and progression-free survival (PFS) in PIK3CA-mutant, hormone receptor positive (HR+) BC versus ET alone; thus, better understanding the clinical and epidemiologic elements of these mutations is warranted. This systematic review characterizes the PIK3CA mutation epidemiology, type of testing approaches (e.g., liquid or tissue tumor biopsy), and stability/concordance (e.g., consistency in results by liquid versus solid tumor sample, by the same method over time) in patients with HR+/HER2– advanced (locally unresectable) or metastatic disease (HR+/HER2– mBC) and explores performance (e.g., pairwise concordance, sensitivity, specificity, or predictive value) of respective mutation findings. A comprehensive search of PubMed/MEDLINE, EMBASE, Cochrane Central, and select conference abstracts (i.e., AACR, ASCO, SABCS, ECCO, and ESMO conferences between 2014 and 2017) identified 39 studies of patients with HR+, HER2– mBC. The median prevalence of PIK3CA mutation was 36% (range: 13.3% to 61.5%); identified testing approaches more commonly used tissue over liquid biopsies and primarily utilized next-generation sequencing (NGS), polymerase chain reaction (PCR), or Sanger sequencing. There was concordance and stability between tissues (range: 70.4% to 94%) based on limited data. Given the clinical benefit of the PI3Ki alpelisib in patients with PIK3CA mutant HR+/HER2– mBC, determination of tumor PIK3CA mutation status is of importance in managing patients with HR+/HER2– mBC. Prevalence of this mutation and utility of test methodologies likely warrants PIK3CA mutation testing in all patients with this breast cancer subtype via definitive assessment of PIK3CA mutational status.

What is value? Impact assessment of cultural heritage

PurposeThere are currently various methodologies used for carrying out impact assessments of cultural heritage. This paper aims to critically explore the reasons for this diversity and ascertain their varying consistency.Design/methodology/approachThe paper does a comparative analysis of the methodologies used, exploring how they measure up to the theoretical underpinnings of the ecosystem services approach and the cultural values model, considered to be the most comprehensive strategies for assessing the impact of cultural heritage.FindingsThe study reveals that there are few methodologies, and they only inconsistently work upon the theoretical perspectives mentioned earlier. In addition, from the public policy perspective, surprisingly few areas endowed with cultural heritage have been, in one way or another, assessed for impact, perhaps in part due to the lack of adequate methodologies.Research limitations/implicationsThe methods analysed are those that have been made public, which can be found in English. Also, they may be exploratory themselves, so some of the conclusions reached here may have also been found by the analysts themselves. This research serves to provide some scientific groundings for developing a more comprehensive impact assessment method.Practical implicationsThe results of this paper highlight certain glaring absences from current methodologies which invite the development of more definitive cultural impact assessment models. This is possible given the current state of the art, and further research and practice are necessary to develop a more comprehensive cultural values model–based research assessment.Social implicationsBy focussing on the absence of certain indicators on behalf of impact assessment methodologies, this paper sheds light on the overlooked (or under-measured) benefits derived from cultural heritage. Many of the benefits derived from this type of resource find an opportunity to come out in the open, greatly affecting researchers, cultural heritage planners and local communities.Originality/valueThis paper also serves to substantiate a glaring absence within the ecosystem services framework, which is the lack of practical methodologies for measuring some of these service values.

Popularity prediction on vacation rental websites

In the personal house renting scenario, customers usually make quick assessments based on previous customers' reviews, which makes such reviews essential for the business. If the house is assessed as popular, a Matthew effect will be observed as more people will be willing to book it. Due to the lack of definition and quantity assessment measures, however, it is difficult to make a popularity evaluation and prediction. To solve this problem, the concept of house popularity is well defined in this paper. Specifically, the house popularity is decided by inter-event timeand rating score at the same time. To make a more effective prediction over these two correlated variables, a dual-gated recurrent unit (DGRU) is employed. Furthermore, an encoder-decoder framework with DGRU is proposed to perform popularity prediction. Empirical results show the effectiveness of the proposed DGRU and the encoder-decoder framework in two-correlated sequences prediction and popularity prediction, respectively.