Requests For Use Research Articles

WITHDRAWN: Post-Brexit implications: Review of marketing authorisations in Malta

Geopolitical incidences such as Brexit can have a significant impact on the stability of the pharmaceutical supply chain and availability of medicines in a small island state like Malta. During Brexit amendments in existing policies in the medicine supply chain were required in Malta and requests for exemptions from the requirement of a marketing authorization (MA) through application of Article 20 of the Maltese Medicines Act could be made. The study aimed to understand whether Brexit affected medicine availability in Malta by identifying which medicines are not available post-Brexit. Review of the (i) Maltese Government Formulary List (GFL) and (ii) Malta Medicines Authority (MMA) database was undertaken and statuses of MA of medicines were identified. Availability of medicines with Withdrawn or Invalidated MA from the UK via alternative routes was checked. For medicinal products in the GFL, 11 had MAs previously held in the UK and for 4 of them, there were no requests for use of Article 20. Review of the MMA database identified 542 MAs with MA holders based in the UK that were withdrawn by companies and 544 MAs that were Invalidated MAs from the UK because they no longer met requirements in the EU legislation. The study sheds light on the impact of Brexit on availability of medicines which have a MA in Malta.

Assessment of the feed additive consisting of endo-1,4-β-xylanase produced by Trichoderma reeseiCBS 143953 and endo-1,3(4)-β-glucanase produced by T. reeseiCBS 143945 (Axtra® XB 201 TPT/L) for poultry and pigs for renewal of its authorisation (Danisco (UK) Ltd).

Following a request from the European Commission, the EFSA Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the renewal of the authorisation of endo-1,4-β-xylanase produced by Trichoderma reesei CBS 143953 and endo-1,3(4)-β-glucanase produced by T. reesei CBS 143945 (Axtra® XB 201 TPT/L) as a zootechnical feed additive (digestibility enhancers) for poultry and pigs. The endo-1,4-β-xylanase and endo-1,3(4)-β-glucanase are produced by a genetically modified strain of T. reesei and a non-genetically modified strain of T. reesei, respectively. The applicant also requested a reduction of the minimum recommended level for turkeys for fattening and the extension of use to other species/categories. The Panelconcluded that the additive complies with the conditions of the current authorisation. There is no new evidence that would lead the FEEDAP Panelto reconsider previous conclusions on the safety of the additive. These conclusions apply also to the new target species/categories for which a request of use was made, suckling piglets. The Panelconcluded that the additive should be considered irritant to eyes and a respiratory sensitiser. However, no conclusions could be drawn on the skin irritancy/sensitisation potential of the additive. No change in the authorisation conditions were requested for poultry species (other than turkeys), weaned piglets, pigs for fattening, sows and minor porcine species; therefore there was no need for an assessment on the efficacy of the additive for those species/categories. The Panelconcluded that the additive has the potential to be efficacious in turkeys for fattening/reared for breeding and in suckling piglets (for the period in which solid feed is administered) at an intended level of 610 xylanase U/kg and 76 glucanase U/kg feed. However, the Panelnoted that the actual effective level used in the studies supporting this conclusion was approximately 50% higher than the intended level.

Overview of the Characteristics of the Modular Industry and Barriers to its Increased Market Share

Modular and offsite construction approaches reduce project duration and cost by synchronizing offsite and onsite work. Project activities are undertaken in a controlled offsite facility to minimize the effects of inclement weather and site disruptions, while meeting safety and quality requirements. To study the characteristics of modular and offsite construction, questionnaires have been conducted during the last decade by many organizations, including the Modular Building Institute (MBI), the Buildoffsite campaigning organization in the United Kingdom, the Canadian Manufactured Housing Institute, the National Institute of Building Sciences, McGraw-Hill Construction, and the Fails Management Institute. This paper introduces comprehensive analysis of the results of a questionnaire survey carried out in collaboration between members of the Department of Building, Civil & Environmental Engineering at Concordia University, the Modular Building Institute, NRB Inc., and the Department of Civil & Environmental Engineering at the University of Alberta. The questionnaire focuses on two issues: (1) the characteristics of the modular and offsite construction industry, and (2) the barriers against increased market share in this industry. For the latter, an effort was made to address a set of five factors identified in a workshop on the topic of challenges and opportunities for modular construction in Canada held in Montréal in 2015 to analyze barriers to growth of modular construction in the Canadian context. Key findings of this survey include requests for use of a separate building code for modular construction design, innovative financing and insurance solutions, standards that consider procurement regulations, and for financial institutions to create lending programs suited for modular construction.

Safety and efficacy of the feed additive consisting of endo-1,4-beta-xylanase produced by Trichoderma reeseiCBS 143953 (Danisco Xylanase 40000 G/L) for poultry and porcine species (Danisco Animal Nutrition).

Danisco Xylanase 40000 G/L is the trade name of the feed additive under assessment and contains endo‐1,4‐beta‐xylanase produced by a genetically modified strain of Trichoderma reesei. It is authorised for use in chickens for fattening, laying hens, ducks, turkeys for fattening, all minor poultry species, weaned piglets and pigs for fattening. This scientific opinion concerns the request for the renewal of the authorisation of the additive for the species/categories for which there is an authorisation, a reduction of the minimum recommended level in turkeys for fattening and the extension of use to all poultry species (other than ducks) for fattening or reared for laying/breeding and for laying, suckling piglets and minor growing porcine species. The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation. There is no new evidence that would lead the EFSA Panel on Additives and products or Substances used in Animal Feed (FEEDAP) to reconsider previous conclusions that the additive remains safe for the animal species/categories, the consumer and the environment under the authorised conditions of use. This conclusion applies also to the new target species/categories for which a request of use is made. The additive is not irritant to skin but should be considered as a possible eye irritant and, in common with other proteinaceous substances, respiratory sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation for chickens for fattening, laying hens, ducks, all minor poultry species, weaned piglets and pigs for fattening. The additive has the potential to be efficacious at 625 U/kg complete feed in all poultry species for fattening (including turkeys) or reared for laying/breeding, and for laying and 2,000 U/kg complete feed in suckling piglets and all minor growing porcine species.

Safety and efficacy of the feed additive consisting of Clostridium butyricum FERM BP-2789 (Miya-Gold® S) for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), piglets (suckling and weaned) and minor porcine species (Miyarisan Pharmaceutical Co. Ltd.).

The feed additive under assessment (trade name: Miya‐Gold® S) is based on viable spores of Clostridium butyricum FERM BP‐2789. It is authorised for use in minor avian species (excluding laying birds), weaned piglets and minor weaned porcine species, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. This opinion concerns the request for renewal of the authorisation of Miya‐Gold® S for the species/categories for which an authorisation exists, the use in chickens for fattening, for which the previous authorisation had expired, and the extension of use to suckling piglets and suckling minor porcine species. The applicant provided evidence that the additive currently in the market complies with the conditions of authorisation. There is no new evidence that would lead the Panel to reconsider previous conclusions that Miya‐Gold® S remains safe for the animal species/categories, the consumer and the environment under the current and previously authorised conditions of use. This conclusion applies also to the new target species for which a request of use is made. Regarding the safety for the user, the Panel concluded that the additive is not irritant to skin and eyes and that sensitisation via respiratory route cannot be excluded. There is no need for assessing the efficacy of Miya‐Gold® S in the context of the renewal of the authorisation in chickens reared for laying, turkeys for fattening and reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species. The additive has the potential to be efficacious in chickens for fattening, suckling piglets and suckling minor porcine species at the level of 2.5 × 108 CFU/kg complete feedingstuff. Miya‐Gold® S is compatible with decoquinate, diclazuril, lasalocid, maduramicin ammonium, narasin, narasin/nicarbazin, monensin sodium, robenidine, salinomycin sodium and semduramicin.

Developing the model of reliability of a complex technical system of repeated use with a complex operating mode

Solving the problems of setting requirements to the reliability of complex technical systems for various purposes presupposes their classification according to the features characterizing the purpose, modes of use, etc. According to the modes of use, systems are divided into objects of continuous long-term use, repeated cyclic use, and single-use. The objects of repeated cyclic use include the systems operating in cycles. Durations of the periods of work and pause in the cycle are considered deterministic values. Technological and/or technical maintenance is carried out in pauses between the operation periods. In addition to the known classification, it was proposed to introduce a group of systems of repeated use with a complex operating mode. A complex mode is understood as a mode that includes waiting for a request of the system use and executing the request after it arrives at a random time. An analytical model of reliability of such a system has been developed in the form of a ratio for a non-stationary total coefficient of operational readiness. This model describes the processes of the system functioning in the intervals of waiting and use. In this case, the duration of the intervals of waiting and/or execution of the request are random values. Ratios for this indicator were obtained for three options of specifying the functions of distribution of durations of waiting in a turn-on condition and fulfilling the request for use. The developed model makes it possible to set requirements for reliability and maintainability of the systems with a complex operating mode. The results of modeling the dependences of the operational indicators of reliability on parameters of the functions of distribution of durations of waiting and executing the request were obtained for different distributions. Recommendations were formulated concerning the substantiation of the requirements to reliability and maintainability of the systems under consideration

The Relationship Of Demand Utilization Of Health Service With Patient Satisfaction At Inpatient Care Unit Of Anuntaloko General Hospital

Hospital is a comprehensive form of health service institution, includes aspects of promotive, preventive, curative and rehabilitation, as well as a public health referral center. Demand on healthcare service theory consists of revenue, visit cost and service quality. Anuntaloko Regional General Hospital Parigi Moutong Regency is a referral center and regionalization hospital in Central Sulawesi Province, which the number of visits in 2016 to 2018 in a row were 19.186, 10.971 and 12.954. The study was purposed to determined Relation Between Requests for Use of Health Service and Patient Satisfaction on Inpatient Care Unit at Anuntaloko Regional General Hospital Parigi Moutong Regency. This was a quatitative analysis research with the cross sectional study approach. The population was patients on Inpatient Care Unit of Anuntaloko Regional General Hospital which amounted to 12.954 sampels and through purposive sampling technique. Data was analyzed univariate and bivariate variables using Chi-Square Test. The results showed that there are relation between revenue (p=0,002), visit cost (p=0,002) and service quality (p=0,000) with patients satisfaction on Inpatient Care Unit at Anuntaloko Regional General Hospital Parigi Moutong Regency. The Anuntaloko Regional General Hospital Parigi Moutong Regency is expected to observe routinly so that maintaining the service quality of the good things and improving the service quality of the lack variabels.

Abstract P1-15-08: Real world data on treatment patterns before and after reporting of the KATHERINE trial: A phase 3 study of adjuvant Ado-trastuzumab emtansine (TDM1) versus trastuzumab in early stage HER+ breast cancer

Abstract BACKGROUND: At SABCS 2018 and simultaneous publication in the NEJM, results of the phase 3 KATHERINE clinical trial comparing TDM1 vs trastuzumab as adjuvant therapy in patients with HER2-positive early-stage breast cancer with residual invasive disease after receiving neoadjuvant chemotherapy and trastuzumab, showed that TDM1 reduced the risk of invasive recurrence or death by 50%. We sought to determine the effect of the release of this data on clinical practice of general medical oncologists in the US by comparing the requests for treatment authorization for TDM1 in the quarters preceding and following SABCS 2018. METHODS: data from a pre-authorization platform used by multiple commercial insurance companies in the US (Eviti) was analyzed. Analysis for request for use of TDM1 was limited to 2nd and 3rd line of therapy in patients with a diagnosis of HER2+ breast cancer in stage <4 patients. Between 1/1/2018 and 6/30/2019, 29,525 breast cancer treatment plans were identified, of which 7,969 were identified as HER2-NEU+ (27%), either IHC3+ or FISH+. TDM1 was prescribed at any line of therapy in 886 patients (11%). RESULTS: Before April 5th 2019, when the adjuvant TDM1 regimen was published, users who entered the drug would have to pick one of the other 2 TDM1 regimens (1st line or 2nd line+). They could change the line of therapy to adjuvant if appropriate. TDM1 authorizations are shown in TABLE 1, indicating an immediate increase in TDM1 use in the quarter following SABCS and based on the quarter 2, 2019 data showing a 42% adjuvant-use rate, we model that 99 cases would have received adjuvant TDM1 in Q1 2019 after 0 in Q4 2018. Q 1, 2018Q 2, 2018Q 3, 2018Q 4, 2018Q 1, 2019Q 2, 2019TDM1 Adjuvant097TDM1 First Line11178195925TDM1 Second Line+104939276177108 CONCLUSIONS: Clinical uptake of practice changing data presented at SABCS 2018 regarding TDM1 was relatively rapid. SABCS and rapid simultaneous publication serves as an important and effective mechanism to communicate practice changing clinical data to practicing oncologists in the US. Citation Format: Neil Margolis, Vlad Kozlovsky, William Flood, Sandeep Reddy. Real world data on treatment patterns before and after reporting of the KATHERINE trial: A phase 3 study of adjuvant Ado-trastuzumab emtansine (TDM1) versus trastuzumab in early stage HER+ breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-15-08.

Real-world data on treatment patterns of advanced CRC in third-line and beyond.

56 Background: NCCN guidelines state “regorafenib (Stivarga) [REG], and Trifluridine+Tipiracil (Lonsurf) [LON] are treatment options for patients who have progressed through all available regimens”. Available clinical trial data has not established whether recycling of prior regimens (oxaliplatin/irinotecan/5FU) with exchange of biologics (bevacizumab, ziv-aflibercept, cetuximab, panitumumab) is superior to changing class of therapy with oral well tolerated agents such as REG and LON. Methods: Data from a pre-authorization platform used by multiple commercial insurance companies in the US (Eviti) was analyzed. 6325 treatment plans of advanced CRC patients were evaluated. Analysis for request for use of REG and LON was limited to third-line and later of therapy in patients with a diagnosis of advanced CRC patients. Results: Of 394 treatment plans beyond second-line of therapy, REG was preferred over LON (239 v 155). Excluding growth factors, anti-emetics, and leucovorin, REG and LON were the 9th and 13th most frequently requested drugs in this clinical setting. Irinotecan was the most commonly requested drug in this setting at >10x the frequency of REG. Ramucirumab was requested more often than REG, and Pembrolizumab, Nivolumab, and Ziv-aflibercept were more requested than LON. HEOR models that included expected supportive care drugs and medication complication management fees estimated the cost of REG at $62,515 per patient versus LON at $26,596 with similar duration of therapy. Conclusions: Therapeutic preferences exist in third-line and later treatment of advanced CRC patients which cannot be fully explained by clinical trial outcome differences, HEOR cost differences, or NCCN guideline preferences. Recycling of chemotherapy and biologics in the late line setting is common and occurs more frequently than switching to a drug regimen with an alternative mechanism of action.

1404. The FilmArray Meningitis/Encephalitis (FA ME) May Be of Higher Yield in the Immunocompromised Patient Population

BackgroundThe FilmArray® Meningitis/Encephalitis (FA ME) panel is a PCR-based assay that rapidly detects 14 pathogens directly from CSF specimens. After the introduction of this assay at our institution, there was a steady increase in requests for use; however, the positivity rate remained stable. We sought to understand the characteristics of the patients most likely to have a positive FA ME panel, with particular interest in the immune status of each patient.MethodsA retrospective chart review was conducted on 124 patients with suspected infectious meningitis/encephalitis at a large academic tertiary referral center who received FA ME testing between October 2016 and November 2018. Patients were considered immunocompromised if they had received chemotherapy, were solid-organ transplant recipients, or were diagnosed with HIV, autoimmune diseases on immunosuppressants, uncontrolled diabetes, cirrhosis, or hematologic malignancy. Clinical CNS infection was determined using chart review based on culture, serologic, or molecular data.Results60 (48%) patients were immunocompromised and 64 (52%) patients were immunocompetent. Clinical CNS infection occurred in ~25% of immunocompetent (17, 26%) and immunocompromised (17, 28%) patients. However, only 6 immunocompetent patients were found to have a positive FA ME; this accounts for only 35% of the total number of positive FA ME assays during this study period (P = 0.08). Notably, 4 out of 6 patients with cryptococcal meningitis had false-negative results on the FA ME.ConclusionIn spite of the relatively small sample size, there was a trend toward significance in the accurate yield of the FA ME panel in the immunocompromised population compared with the immunocompetent. Our immunocompromised patients appear to be more likely to have an infection which is tested for on the panel. The rates of confirmed CNS infections in both populations were very similar, indicating that immunocompromised patients may benefit more from use of this assay. In our study, immunocompetent patients were more likely to have West Nile infection, for example, which is not on the panel. Additionally, had cryptococcal meningitis been accurately diagnosed by the FA ME, an even greater number of immunocompromised patients would have had a positive FA ME. Disclosures All authors: No reported disclosures.

"As Long as You Ask": A Qualitative Study of Biobanking Consent-Oncology Patients' and Health Care Professionals' Attitudes, Motivations, and Experiences-the B-PPAE Study.

Consent to biobanking remains controversial, with little empirical data to guide policy and practice. This study aimed to explore the attitudes, motivations, and concerns of both oncology patients and health care professionals (HCPs) regarding biobanking. Qualitative interviews were conducted with oncology patients and HCPs purposively selected from five Australian hospitals. Patients were invited to give biobanking consent as part of a clinical trial and/or for future research were eligible. HCPs were eligible if involved in consenting patients to biobanking or to donate specimens to clinical trials. Twenty-two patients participated, with head and neck (36%) and prostate (18%) the most common cancer diagnoses; all had consented to biobanking. Twenty-two HCPs participated, from across eight cancer streams and five disciplines. Themes identified were (a) biobanking is a "no brainer"; (b) altruism or scientific enquiry; (c) trust in clinicians, science, and institutions; (d) no consent-just do it; (e) respecting patient choice ("opt-out"); (f) respectful timing of the request; (g) need for emotional/family support; (h) context of the biobanking request matters; and (i) factors for biobanking success. These findings reinforced previous findings regarding high public trust in, and support for, biobanking. An initial opt-in consent approach with the option of later opt-out was favored by patients to respect and recognize donor generosity, whereas HCPs preferred an upfront opt-out model. Factors impacting biobanking success included the context of the request for use in a trial or specific research question, pre-existing patient and HCP rapport, a local institution champion, and infrastructure. Patients and health care professionals (HCPs) who experienced cancer biobanking consent were overwhelmingly supportive of biobanking. The motivations and approaches to seeking consent were largely mirrored between the groups. The findings of this study support the opt-in model of biobanking favored by patients; however, HCPs preferred an opt-out model. Both groups recognize the importance of making the request for biobanking at an appropriate time, preferably with emotional or family support, and respecting the timing of the request and privacy of the patient. Biobanking success can be promoted by hospital departments with a research focus by identifying an institutional biobanking champion and ensuring local infrastructure is available.

Modular Industry Characteristics and Barriers to its Increased Market Share

Modular and offsite construction reduces project duration and cost by synchronizing offsite and onsite work. Project activities are constructed in a controlled offsite facility to minimize effects of inclement weather and site disruptions, while meeting safety and quality requirements. In recent years, many organizations have conducted questionnaires to study characteristics of modular and offsite construction, such as the Modular Building Institute (MBI), Buildoffsite campaigning organisation in the UK, Canadian Manufactured Housing Institute (CMHI), National Institute of Building Sciences, McGraw-Hill Construction, and Fails Management Institute (FMI). This paper introduces a summary of results for a new questionnaire carried out in collaboration between the Department of Building, Civil and Environmental Engineering (BCEE) at Concordia University, MBI, Niagara Relocatable Buildings, Inc. (NRB) in Canada, and the Nasseri School of Building Science and Engineering at the University of Alberta. This questionnaire focuses on two issues: (1) the characteristics of the modular and offsite construction industry, and (2) detected barriers to the increased market share of this industry. For the latter, effort was made to address five factors emanated from a workshop on äóěChallenges and opportunities for modular construction in Canadaäóť held in Montreal in October 2015 to analyze barriers to growth of modular construction in Canada. Key findings of this questionnaire include requests for use of a separate code of modular construction design, innovative financing and insurance solutions, standards that consider procurement regulations, and lending institutions that partner with financial houses to create special lending programs for modular construction.

The appropriate use of human albumin in a Brazilian University Hospital: therapeutic indication and dosage regimen

The objective of the study was to evaluate the use of human albumin in a Brazilian university hospital, in compliance with the institutional protocol and other clinical guidelines, taking into account the therapeutic indications and the dosage regimens. Data was obtained from the pharmacy dispensing records of human albumin, the requests for use it and, when available, the patient’s records between January and October 2017. After evaluation the therapeutic indications and the dosage regimens were classified as “appropriate” and “inappropriate”. The analysis of 98 requests showed that, when compared to the institutional protocol, 54 (55.1%) requests had an inappropriate therapeutic indication. However, when a comparison was made between 25 medical records (54 requests) and other clinical guidelines, it was observed that the therapeutic indication had none classified as inappropriate. In addition, 16 (29.7%) requests were considered inappropriate in relation to dosage regimens. From these results, it was possible to conclude that although the use of human albumin in the hospital was associated to a clinical protocol, it was outdated. Thus, it is possible to affirm that not only the adoption of a clinical protocol, but its periodical updating is an important strategy to promote the rational use of drugs.

Development of Animation Projector System and Usefulness in Pediatric Head CT

The restlessness of young children often causes motion artifacts on CT images. We devised a new animation projector system (CT Theater) that enables a child to view an animation during a pediatric head CT examination. The purpose of this study is to assess the usefulness on a children of a video viewed during a head CT scan. Children of 3-10 years old who underwent head CT (SOMATOM Definition Flash, SOMATOM Force; Siemens) were analyzed for a period from 6 months before, to 6 months after, introduction of the projector system (before: n=46, after: n=29). Mobile projector (MP-CL1; Sony) connected with tablet device (iPad; Apple) was put on the CT table near the child's head. An animation was projected on the child's line of sight inside the gantry. The animation is projected on the line of sight of the child such that the projector moves with the child on the table. The number of requests for use made by children was 28/29 (96.6%). The presence of images without motion artifacts decreased significantly after introduction (before/after introduction: 84.8% vs 100%, p=0.03). The overall examination success rate tended to increase after introduction (84.8% vs 92.9%, p=0.26). The overall examination time was significantly reduced (92.4±42.4 s vs 65.1±47.3 s, p<0.001). We developed an animation projector system that shortened examination time and decreased motion artifacts in pediatric head CT.

Phase I–III development of the EORTC QLQ-ANL27, a health-related quality of life questionnaire for anal cancer

Background and purposeThere is currently no health-related quality of life (HRQoL) measure specific to anal cancer. Our objective was to develop an anal cancer HRQoL module to supplement the EORTC QLQ-C30 questionnaire using EORTC Quality of Life Group Guidelines. Materials and methodIn order to generate a list of HRQoL issues facing anal cancer patients treated with chemoradiotherapy (CRT), we systematically reviewed the literature and conducted semi-structured interviews with patients and health care professionals (HCPs). Our list was then operationalised into questions using the EORTC Item Library. The provisional question list was pilot tested alongside the EORTC QLQ-C30 with patients from 11 centres across 8 countries. ResultsFrom our literature review and interviews with 43 patients, we generated a list of 197 issues. The list was then refined to 134 issues and reviewed by 34 HCPs and 10 patients. This review resulted in the retention of 65 issues which were used in the draft questionnaire tested by 100 patients. Our analyses led to the modification and removal of questions resulting in a 27 item questionnaire, the EORTC QLQ-ANL27. ConclusionWe have developed a 27 item questionnaire to supplement the EORTC QLQ-C30, for use with patients treated for anal cancer. This has been pilot tested and is now available upon request for use in clinical trials as well as clinical practice in 8 languages (http://groups.eortc.be/qol/).

The Seed to Supper Program and Its Effect on Low-Income Beginning Gardeners in Oregon

Extension and community partner organizations work together to address complex problems such as food insecurity. One effort showing high levels of success in Oregon is the Seed to Supper program. This classroom-based beginning gardening curriculum targets low-income adults. Program participants indicated reducing their grocery bills as a result of growing their own food and eating more fruits and vegetables than usual during the growing season. Additionally, the program has increased participant awareness that Supplemental Nutrition Assistance Program benefits can be used to purchase seeds or transplants. The curriculum is available on request for use by other state Extension offices.

“There is No Need for Translation: She Understands”: Teachers’ Mediation Strategies in a Bilingual Preschool Classroom

In this study, we explored how major theoretical principles and concepts in the mediation strategies of Vygotsky's sociocultural theory are realized in an Arabic−Hebrew preschool in Israel. The aim of this study was to examine how teachers encourage children to use their second language (L2) during teacher−child conversations. In particular, as a response to relatively low motivation for L2 (Arabic) use, the teachers’ mediation was intended to encourage children to use Arabic.The study participants were one Hebrew model teacher, one Arabic model teacher, and children using either Hebrew or Arabic as their first language (L1). We applied a thematic analysis as the methodological framework. Data were collected during one academic year, including video recordings of the teacher−child conversations, and were analyzed quantitatively and qualitatively. The following content categories were extracted: explicit request for use of the L2, managing the children's demand for direct translation, the teacher as a model for the L2 learner, and contributions from language experts. The observation showed that the teachers applied diverse mediation strategies, such as scaffolding, identification of the child's zone of proximal development, and modeling. Avoidance of direct translation was intended to activate children's zone of proximal development and to boost their involvement in L2 learning.

Rapid HIV test in family practice

BackgroundThe 2010-2014 HIV/AIDS French program recommends using HIV rapid diagnostic tests in family practice. Our aim was to assess the acceptability and feasibility of the RDT in family practice in France. MethodsThe first part of this study was to determine the opinions of family practitioners (FPs) concerning the news guidelines for screening and the possible use of rapid HIV tests in their practice. The second part was a feasibility study of the actual use of rapid HIV tests given to FPs during six months. The third part was a qualitative analysis of experience feedback to determine the impediments to using rapid HIV tests. ResultsSeventy-seven percent of the 352 FPs interviewed were favorable to rapid HIV tests use. The three main impediments were: misinterpretation of test result, complexity of quality control, and lack of training: 23 of the 112 FPs having volunteered to evaluate the rapid HIV tests followed the required training session. Sixty-nine tests were handed out, and three rapid HIV tests were used; the qualitative study involved 12 FPs. The participants all agreed on the difficult use of rapid HIV tests in daily practice. The main reasons were: too few opportunities or requests for use, complex handling, difficulties in proposing the test, fear of having to announce seropositivity, significantly longer consultation. ConclusionAlthough FPs are generally favorable to rapid HIV tests use in daily practice, the feasibility and contribution of rapid HIV tests are limited in family practice.

SurgiCal Obesity Treatment Study (SCOTS): protocol for a national prospective cohort study of patients undergoing bariatric surgery in Scotland

IntroductionThe efficacy of bariatric surgery for large-scale, long-term weight loss is well established. However, many questions remain over the continual benefits and cost-effectiveness of that weight loss for overall health,...

Optimisation of technological transport in quarries using application software

One of basic conditions of transport optimising in a quarry is effective use of machinery and minimising of downtimes to be occurred. This condition may be reached good organisation and operation management of loading and transporting. Expenses for optimum management and organisation of transport are growing with increasing mining capacity and amount of mechanisms used within the transporting system. For larger installations, there is a request for use of computer applications to solve tasks related to optimisation of the transport system. In this paper a proposal is presented for transport optimisation in a particular quarry operation using electronic information collection to be performed by means of PDA device and applied software developed for transport management needs.