bluuebunny/crossref_metadata_2025_split huggingface dataset:
Developing medical device technologies from users' perspectives: A theoretical framework for involving users in the development process
Authors: Shah Syed Ghulam Sarwar , Robinson Ian , AlShawi Sarmad 
Published: October 2009

Objectives: The aim of this study was to suggest an acceptable and generic theoretical framework for involving various types of users in the medical device technology (MDT) development process (MDTDP).Methods: The authors propose a theoretical framework suggesting different routes, methods and stages through which various types of medical device users can be involved in the MDTDP.Results: The suggested framework comprises two streams of users’ involvement in MDT development, that is, what might be called the end users’ stream and the professional users’ stream for involving these two groups respectively in the process of developing both simple and more complex and innovative medical devices from conceptualization through to the market deployment. This framework suggests various methods that can be used for users’ involvement at different stages of the MDT lifecycle. To illustrate the application of the framework, several MDT development scenarios and device exemplars are presented.Conclusions: Development of medical devices from users’ perspectives requires not only the involvement of healthcare professionals but also that of the ultimate end users, that is, patients, people with disabilities and/or special needs, and their caregivers. The evidence shows that such end users quickly discard devices that do not fulfill their personal expectations, even though both manufacturers and healthcare professionals may consider those end users’ requirements met. Developers and manufacturers need to recognize this potent potential discrepancy between the parties involved, and involve end users and professional healthcare staff directly in the MDTDP. The framework, the authors contend, is a step forward in helping medical device manufacturers plan and make decisions about users’ involvement at different stages of the MDTDP.
A content analysis of health technology assessment programs in Latin America
Authors: Arellano Luis E. , Reza Mercedes , Blasco Juan Antonio , Andradas Elena 
Published: October 2009

Objectives:Health Technology Assessment (HTA) is a relatively new concept in Latin America (LA). The objectives of this exploratory study were to identify HTA programs in LA, review HTA documents produced by those programs, and assess the extent to which HTA aims are being achieved.Methods:An electronic search through two databases was performed to identify HTA programs in LA. A content analysis was performed on HTA documents (n= 236) produced by six programs between January 2000 and March 2007. Results were analyzed by comparing document content with the main goals of HTA.Results:The number of HTA documents increased incrementally during the study period. The documents produced were mostly short HTA documents (82 percent) that assessed technologies such as drugs (31 percent), diagnostic and/or screening technologies (18 percent), or medical procedures (18 percent). Two-thirds (66 percent) of all HTA documents addressed issues related to clinical effectiveness and economic evaluations. Ethical, social, and/or legal issues were rarely addressed (<1 percent). The two groups most often targeted for dissemination of HTA information were third-party payers (55 percent) or government policy makers (41 percent).Conclusions:This study showed that while HTA programs in LA have attempted to address the main goals of HTA, they have done so through the production of short documents that focus on practical high-technology areas of importance to two specific target groups. Clinical and economic considerations still take precedence over ethical, social, and/or legal issues. Thus, an integrated conceptual framework in LA is wanting.
Knowledge network for medical technology management in Mexico
Authors: Licona Fabiola Martínez , Leehan Joaquín Azpiroz , Méndez Miguel Cadena , Yuriar Salvador Duarte , Salazar Raúl Molina , Gilmore Amador Terán 
Published: October 2009

Objectives: The role of biomedical engineers (BMEs) has changed widely over the years, from managing a group of technicians to the planning of large installations and the management of medical technology countrywide. As the technology has advanced, the competence of BMEs has been challenged because it is no longer possible to be an expert in every component of the technology involved in running a hospital. Our approach has been to form a network of professionals that are experts in different fields related to medical technology, where work is coordinated to provide high quality services at the planning and execution stages of projects related to medical technology.Methods: A study of the procedures involved in the procurement of medical technology has been carried out over the years. These experiences have been compared with several case studies where the approach to problem solving in this area has been multidisciplinary. Planning and execution phases of projects involving medical technology management have been identified.Results: After several instances of collaboration among experts from different fields, a network for management of healthcare technology has been formed at our institution that incorporates the experience from different departments that were dealing separately with projects involving medical technology.Conclusions: This network has led us to propose this approach to solve medical technology management projects, where the strengths of each subgroup complement each other. This structure will lead to a more integrated approach to healthcare technology management and will ensure higher quality solutions.
Quality of trials reported as conference abstracts in China: How well are they reported?
Authors: Duan Yurong , Li Jing , Ai Changlin , Chen Yaolong , Chen Peixian , Zhang Mingming , Hopewell Sally 
Published: October 2009

Objectives: Clear, transparent, and sufficiently detailed abstracts of journal articles and conference abstracts are important because readers often base their assessment of a trial on such information. There are concerns over the reliability and quality of trials published only in the proceedings of scientific meetings. This study aims to assess the reporting quality of abstracts of randomized trials published in Chinese medical conference abstracts.Methods: Conference abstracts reporting randomized trials included in the China National Knowledge Infrastructure (CNKI) in 2007 were identified. A revised checklist (based on the CONSORT extension for reporting randomized controlled trials in journal and conference abstracts) was used to assess the reporting quality of these conference abstracts.Results: A total of 567 conference abstracts of randomized trials were identified. Some aspects were well reported, including 94 percent of authors contact details, 83 percent of trial interventions and 78 percent of control interventions, 62 percent of participant eligibility criteria, and 66 percent the number of participants randomized to each group. Other areas were very poorly reported: only 1 percent identified the study as randomized in the abstract title, 2 percent reported the trial design, and only 7 percent reported on blinding. No details of allocation concealment, trial registration, or funding were reported.Conclusion: The information given for trials in conference proceedings in China is very poor, especially in some aspects of methodological quality, trial registration, and funding source. The quality of conference abstracts for trials should be improved to further facilitate understanding of their conduct and validity.
Systematic review of economic evidence for the detection, diagnosis, treatment, and follow-up of colorectal cancer in the United Kingdom
Authors: Tappenden Paul , Chilcott Jim , Brennan Alan , Pilgrim Hazel 
Published: October 2009

Objectives: The aim of this study was to examine the availability and consistency of economic evidence for the detection, diagnosis, treatment, and follow-up of colorectal cancer.Methods: A systematic review of UK economic evaluations of colorectal cancer interventions was undertaken. Searches were undertaken across ten electronic databases. Studies were critically appraised through reference to a conceptual model of UK colorectal cancer services.Results: Forty-seven studies met the inclusion criteria. There is a substantial economic evidence base surrounding population-level colorectal screening, surgical procedures, and cytotoxic therapies for the adjuvant and palliative treatment of colorectal cancer. There is limited evidence concerning the diagnosis of suspected colorectal cancer, curative treatments for metastatic disease and follow-up regimens for nonmetastatic disease. No studies were identified relating to the economics of radiotherapy, surveillance of increased-risk groups, end-of-life care, or the management of hereditary colorectal cancer. Where evidence is available, studies are subject to important differences concerning treatment options, decision criteria, and incongruent assumptions concerning the disease and its management.Conclusions: Across many aspects of the colorectal cancer service, current practice appears to have emerged without the consideration or support of economic evidence. There is a need to develop a common understanding how colorectal cancer models should be structured and implemented.
Cost-effectiveness of prophylaxis against on-demand treatment in boys with severe hemophilia A in Iran
Authors: Daliri Aliasghar Ahmad Kia , Haghparast Hassan , Mamikhani Jahanara 
Published: October 2009

Objective: The aim of this study was to assess the incremental cost-effectiveness of on-demand versus prophylactic hemophilia therapy in Iran from a third-party payers’ perspective.Methods: A retrospective chart review of twenty-five type A hemophiliacs who were treated in three hemophilia treatment centers was conducted. The patients were boys 0–9 years old receiving one of two treatments: (i) prophylaxis with concentrate at clinic; (ii) concentrate at clinic as on-demand. Fourteen boys received on-demand infusions for bleeding events, and eleven boys received infusions prophylaxis. Data were extracted from documents in the hemophilia treatment centers during a period of approximately 6 months.Results: The patients receiving prophylactic treatment had fewer bleeding events each month (mean, 0.26 versus 2.74) but used more concentrate (225.31 versus 87.20 units/kg per month). Average monthly cost per patient in the prophylaxis group was approximately 1.9 times higher than in the on-demand group. Compared with on-demand infusion, prophylaxis costs 3,201,656 Rials (€213.45) per bleeding event prevented.Conclusion: Prophylactic care markedly reduces the number of bleeding episodes, but at considerable cost.
How well do search filters perform in identifying economic evaluations in MEDLINE and EMBASE
Authors: Glanville Julie , Kaunelis David , Mensinkai Shaila 
Published: October 2009

Objectives: Health technology assessment (HTA) agencies assessing the cost-effectiveness of healthcare technologies seek evidence from economic evaluations. As well as searching economic evaluation databases, researchers often search MEDLINE and EMBASE, using search filters whose current performance is unclear. We assessed the performance of search filters in identifying economic evaluations from MEDLINE and EMBASE.Methods: A gold standard of economic evaluations was compiled from National Health Service Economic Evaluation Database (NHS EED) records for 2000, 2003, and 2006. Corresponding records were retrieved in MEDLINE and EMBASE. Search filters were identified from the InterTASC Information Specialists’ SubGroup Web site and from Canadian Agency for Drugs and Technologies in Health (CADTH) Information Services. The sensitivity and precision of search filters in retrieving gold standard records from MEDLINE and EMBASE were tested.Results: A total of 2,070 full economic evaluations were identified from NHS EED. Of these, 1,955 records were available in Ovid MEDLINE and 1,873 were available in Ovid EMBASE. Thirteen MEDLINE and eight EMBASE filters were identified. NHS Quality Improvement Scotland (full and brief filters), the NHS EED and Royle and Waugh filters achieved over 0.99 sensitivity in MEDLINE. NHS Quality Improvement Scotland, CADTH, Royle and Waugh, and NHS EED filters achieved greater than 0.99 sensitivity in EMBASE. Filters demonstrated low precision.Conclusions: This research provided new performance data on search filters to identify economic evaluations in MEDLINE and EMBASE. It demonstrated that highly sensitive economic evaluation filters are available, but that precision is low, yielding perhaps 5 relevant records per 100 records scanned.
Development of health technology assessment in Central Europe
Authors: Kárpáti Krisztián , Sándor János 
Published: October 2009

Once upon a time in the 1990s, if you wanted to do HTA in the Central and Eastern European countries (CEEs), you got yourself invited by Egon Jonsson and travelled to Stockholm to learn how to do HTA. There you met him and Prof. Banta and other HTA professionals from all over the world—very importantly, motivated healthcare professionals from all CEEs who were eager to learn HTA. These eminent founding fathers were always available, and were never tired if help or assistance was needed. During that time, the telephone number of HTA was known and used extensively, making it a real, living, informal HTA network. Formal HTA collaborations organized by them and funded by the European Commission, such as EUR-ASSESS, HTA EUROPE, ECHTA/ECAHI, were also crucial . . .
Point-source outbreak of coccidioidomycosis in construction workers
Authors: CUMMINGS K. C. , McDOWELL A. , WHEELER C. , McNARY J. , DAS R. , VUGIA D. J. , MOHLE-BOETANI J. C. 
Published: October 2009

SUMMARYCoccidioidomycosis results from inhaling spores of the fungusCoccidioidesspp. in soil or airborne dust in endemic areas. We investigated an outbreak of coccidioidomycosis in a 12-person civilian construction crew that excavated soil during an underground pipe installation on Camp Roberts Military Base, California in October 2007. Ten (83·3%) workers developed symptoms of coccidioidomycosis; eight (66·7%) had serologically confirmed disease, seven had abnormal chest radiographs, and one developed disseminated infection; none used respiratory protection. A diagnosis of coccidioidomycosis in an eleventh worker followed his exposure to the outbreak site in 2008. Although episodic clusters of infections have occurred at Camp Roberts, the general area is not associated with the high disease rates found in California's San Joaquin Valley. Measures to minimize exposure to airborne spores during soil-disrupting activities should be taken before work begins in any coccidioides-endemic area, including regions with only historic evidence of disease activity.
Epidemiology and characterization ofStaphylococcus epidermidisisolates from humans, raw bovine milk and a dairy plant
Authors: JAGLIC Z. , MICHU E. , HOLASOVA M. , VLKOVA H. , BABAK V. , KOLAR M. , BARDON J. , SCHLEGELOVA J. 
Published: October 2009

SUMMARYGeographically relatedStaphylococcus epidermidisisolates from human patients (n=30), dairy farms (farmers and individual raw milk from cattle,n=36) and a dairy plant (n=55) were examined for epidemiological relatedness by pulsed-field gel electrophoresis and, usingin vitromethods, for the ability to produce biofilm and antimicrobial resistance. Methicillin-resistant isolates (MRSE) were also identified and characterized. Isolates from farmers and dairy cattle were found to be genetically related, while isolates from human patients were highly diverse. Some dairy plant isolates (18·2%) were closely related to those from dairy farms. Biofilm production and resistance to antimicrobial agents were most typical for isolates from human patients, of which 76·7% were MRSE. Methicillin resistance was also widespread in farm-related isolates (61·1%). This study indicates the possible transmission ofS. epidermidisbetween cattle and farmers. Dairy products were not proven to be an important source of either human infections or methicillin-resistant strains.
The epidemiology of primary amoebic meningoencephalitis in the USA, 1962–2008
Authors: YODER J. S. , EDDY B. A. , VISVESVARA G. S. , CAPEWELL L. , BEACH M. J. 
Published: October 2009

SUMMARYNaegleria fowleri, a free-living, thermophilic amoeba ubiquitous in the environment, causes primary amoebic meningoencephalitis (PAM), a rare but nearly always fatal disease of the central nervous system. While case reports of PAM have been documented worldwide, very few individuals have been diagnosed with PAM despite the vast number of people who have contact with fresh water whereN. fowlerimay be present. In the USA, 111 PAM case-patients have been prospectively diagnosed, reported, and verified by state health officials since 1962. Consistent with the literature, case reports reveal thatN. fowleriinfections occur primarily in previously healthy young males exposed to warm recreational waters, especially lakes and ponds, in warm-weather locations during summer months. The annual number of PAM case reports varied, but does not appear to be increasing over time. Because PAM is a rare disease, it is challenging to understand the environmental and host-specific factors associated with infection in order to develop science-based, risk reduction messages for swimmers.
Emergence and disappearance of W135 meningococcal disease
Authors: WILDER-SMITH A. , CHOW A. , GOH K.-T. 
Published: October 2009

SUMMARYW135 meningococcal disease was imported into Singapore in 2000 via Hajj pilgrims. Previous studies have showed sustained carriage of W135 with the potential for further transmission within communities. We therefore set out to determine whether W135 meningococcal disease would become endemic in Singapore after its introduction in 2000. Cases occurred until 2003, but no further cases have been reported since 2004.
Temporal and farm-management-associated variation in the faecal-pat prevalence ofCampylobacter jejuniin ruminants
Authors: GROVE-WHITE D. H. , LEATHERBARROW A. J. H. , CRIPPS P. J. , DIGGLE P. J. , FRENCH N. P. 
Published: October 2009

SUMMARYIn a 2-year longitudinal study of adult animals on 15 dairy farms and four sheep farms in Lancashire, UK.C. jejuniwas isolated from all farms, although not on every occasion. Faecal samples were collected and cultured using standard techniques for isolation ofCampylobacter. Assignment to species was via PCR assays. Peak prevalence ofC. jejuniin both cattle and sheep was observed during the summer and in cattle this apparent seasonality was associated with grazing pasture [odds ratio (OR) 2·14], while in sheep it was independent of grazing. Increased prevalence was associated with increased milk yield (OR 1·05) and herd size (OR 1·01) in dairy cattle, and with increased stocking density (OR 1·29) and pasture quality (OR 2·16) in sheep. There was considerable variation in prevalence between farms but no evidence of large-scale spatial variation. The association betweenC. jejuniprevalence and diet in dairy cattle deserves further investigation.
Global ecological patterns in uncultured Archaea
Authors: Auguet Jean-Christophe , Barberan Albert , Casamayor Emilio O 
Published: October 2009

Abstract
We have applied a global analytical approach to uncultured Archaea that for the first time reveals well-defined community patterns along broad environmental gradients and habitat types. Phylogenetic patterns and the environmental factors governing the creation and maintenance of these patterns were analyzed for c. 2000 archaeal 16S rRNA gene sequences from 67 globally distributed studies. The sequences were dereplicated at 97% identity, grouped into seven habitat types, and analyzed with both Unifrac (to explore shared phylogenetic history) and multivariate regression tree (that considers the relative abundance of the lineages or taxa) approaches. Both phylogenetic and taxon-based approaches showed salinity and not temperature as one of the principal driving forces at the global scale. Hydrothermal vents and planktonic freshwater habitats emerged as the largest reservoirs of archaeal diversity and consequently are promising environments for the discovery of new archaeal lineages. Conversely, soils were more phylogenetically clustered and archaeal diversity was the result of a high number of closely related phylotypes rather than different lineages. Applying the ecological concept of ‘indicator species’, we detected up to 13 indicator archaeal lineages for the seven habitats prospected. Some of these lineages (that is, hypersaline MSBL1, marine sediment FCG1 and freshwater plSA1), for which ecological importance has remained unseen to date, deserve further attention as they represent potential key archaeal groups in terms of distribution and ecological processes. Hydrothermal vents held the highest number of indicator lineages, suggesting it would be the earliest habitat colonized by Archaea. Overall, our approach provided ecological support for the often arbitrary nomenclature within uncultured Archaea, as well as phylogeographical clues on key ecological and evolutionary aspects of archaeal biology.
Annual Incidence of Latent Tuberculosis Infection among Newly Employed Nurses at a Tertiary Care University Hospital
Authors: Lee Kwangha , Han Min Kyoung , Choi Hye Ran , Choi Chang-Min , Oh Yeon-Mok , Lee Sang Do , Kim Woo Sung , Kim Dong Soon , Woo Jun Hee , Shim Tae Sun 
Published: October 2009

Objective.To investigate the annual rate of tuberculosis (TB) infection among newly employed nurses using both tuberculin skin test (TST) and QuantiFERON-TB Gold (QFT-G; Cellestis Limited) assay.Design.A prospective cohort study involving newly employed nurses.Setting.A tertiary care university hospital in South Korea.Methods.All participants (n = 196) were tested with the TST and QFT-G assay at baseline. After 1 year, the TST and QFT-G assay were reperformed for subjects who had negative TST results at baseline and for all subjects, respectively.Results.The baseline TST and QFT-G assays were positive for 101 subjects (51.5%) and 28 subjects (14.3%), respectively; 22 subjects (11.2%) had positive results of both tests. Although the overall between-test agreement was 54.9% (κ = 0.151 [95% confidence interval, 0.047–0.245]), agreement improved to 78.5% (κ = 0.462 [95% confidence interval, 0.007–0.917]) for subjects who had not received bacille Calmette-Guérin vaccination. After 1 year, the TST yielded positive results for 16 (21.3%) of 75 nurses with negative baseline results, and the QFT-G assay yielded positive results for 21 (14.4%) of 146 subjects with negative baseline Results. Collectively, 5 subjects (3.0%) experienced conversion to positive results with both tests, and 32 subjects (18.9%) experienced conversion to positive results with one of the tests. Neither the employing hospital department nor exposure to patients with TB affected test conversion status.Conclusions.The poor overall agreement between TST and QFT-G results may have been caused by the confounding effect of bacille Calmette-Guérin vaccination. The annual risk of TB infection among newly employed nurses was at least 3% on the basis of results of both the TST and QFT-G test. Stricter preventive strategies against TB spread should be implemented in our hospital.