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Sample records for case-mix system multicentre

  1. The relationship between effectiveness and costs measured by a risk-adjusted case-mix system: multicentre study of Catalonian population data bases

    Directory of Open Access Journals (Sweden)

    Flor-Serra Ferran

    2009-06-01

    Full Text Available Abstract Background The main objective of this study is to measure the relationship between morbidity, direct health care costs and the degree of clinical effectiveness (resolution of health centres and health professionals by the retrospective application of Adjusted Clinical Groups in a Spanish population setting. The secondary objectives are to determine the factors determining inadequate correlations and the opinion of health professionals on these instruments. Methods/Design We will carry out a multi-centre, retrospective study using patient records from 15 primary health care centres and population data bases. The main measurements will be: general variables (age and sex, centre, service [family medicine, paediatrics], and medical unit, dependent variables (mean number of visits, episodes and direct costs, co-morbidity (Johns Hopkins University Adjusted Clinical Groups Case-Mix System and effectiveness. The totality of centres/patients will be considered as the standard for comparison. The efficiency index for visits, tests (laboratory, radiology, others, referrals, pharmaceutical prescriptions and total will be calculated as the ratio: observed variables/variables expected by indirect standardization. The model of cost/patient/year will differentiate fixed/semi-fixed (visits costs of the variables for each patient attended/year (N = 350,000 inhabitants. The mean relative weights of the cost of care will be obtained. The effectiveness will be measured using a set of 50 indicators of process, efficiency and/or health results, and an adjusted synthetic index will be constructed (method: percentile 50. The correlation between the efficiency (relative-weights and synthetic (by centre and physician indices will be established using the coefficient of determination. The opinion/degree of acceptance of physicians (N = 1,000 will be measured using a structured questionnaire including various dimensions. Statistical analysis: multiple regression

  2. Case Mix Management Systems: An Opportunity to Integrate Medical Records and Financial Management System Data Bases

    OpenAIRE

    Rusnak, James E.

    1987-01-01

    Due to previous systems selections, many hospitals (health care facilities) are faced with the problem of fragmented data bases containing clinical, demographic and financial information. Projects to select and implement a Case Mix Management System (CMMS) provide an opportunity to reduce the number of separate physical files and to migrate towards systems with an integrated data base. The number of CMMS candidate systems is often restricted due to data base and system interface issues. The h...

  3. Case Mix Management Systems: An Opportunity to Integrate Medical Records and Financial Management System Data Bases

    Science.gov (United States)

    Rusnak, James E.

    1987-01-01

    Due to previous systems selections, many hospitals (health care facilities) are faced with the problem of fragmented data bases containing clinical, demographic and financial information. Projects to select and implement a Case Mix Management System (CMMS) provide an opportunity to reduce the number of separate physical files and to migrate towards systems with an integrated data base. The number of CMMS candidate systems is often restricted due to data base and system interface issues. The hospital must insure the CMMS project provides a means to implement an integrated on-line hospital information data base for use by departments in operating under a DRG-based Prospective Payment System. This paper presents guidelines for use in selecting a Case Mix Mangement System to meet the hospital's financial and operations planning, budgeting, marketing, and other management needs, while considering the data base implications of the implementation.

  4. A case-mix classification system for explaining healthcare costs using administrative data in Italy.

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    Corti, Maria Chiara; Avossa, Francesco; Schievano, Elena; Gallina, Pietro; Ferroni, Eliana; Alba, Natalia; Dotto, Matilde; Basso, Cristina; Netti, Silvia Tiozzo; Fedeli, Ugo; Mantoan, Domenico

    2018-03-04

    The Italian National Health Service (NHS) provides universal coverage to all citizens, granting primary and hospital care with a copayment system for outpatient and drug services. Financing of Local Health Trusts (LHTs) is based on a capitation system adjusted only for age, gender and area of residence. We applied a risk-adjustment system (Johns Hopkins Adjusted Clinical Groups System, ACG® System) in order to explain health care costs using routinely collected administrative data in the Veneto Region (North-eastern Italy). All residents in the Veneto Region were included in the study. The ACG system was applied to classify the regional population based on the following information sources for the year 2015: Hospital Discharges, Emergency Room visits, Chronic disease registry for copayment exemptions, ambulatory visits, medications, the Home care database, and drug prescriptions. Simple linear regressions were used to contrast an age-gender model to models incorporating more comprehensive risk measures aimed at predicting health care costs. A simple age-gender model explained only 8% of the variance of 2015 total costs. Adding diagnoses-related variables provided a 23% increase, while pharmacy based variables provided an additional 17% increase in explained variance. The adjusted R-squared of the comprehensive model was 6 times that of the simple age-gender model. ACG System provides substantial improvement in predicting health care costs when compared to simple age-gender adjustments. Aging itself is not the main determinant of the increase of health care costs, which is better explained by the accumulation of chronic conditions and the resulting multimorbidity. Copyright © 2018. Published by Elsevier B.V.

  5. Masquerade Syndrome of Multicentre Primary Central Nervous System Lymphoma

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    Silvana Guerriero

    2011-01-01

    Full Text Available Purpose. In Italy we say that the most unlucky things can happen to physicians when they get sick, despite the attention of colleagues. To confirm this rumor, we report the sad story of a surgeon with bilateral vitreitis and glaucoma unresponsive to traditional therapies. Methods/Design. Case report. Results. After one year of steroidal and immunosuppressive therapy, a vitrectomy, and a trabeculectomy for unresponsive bilateral vitreitis and glaucoma, MRI showed a multicentre primary central nervous system lymphoma, which was the underlying cause of the masquerade syndrome. Conclusions. All ophthalmologists and clinicians must be aware of masquerade syndromes, in order to avoid delays in diagnosis.

  6. [Establishment and Management of Multicentral Collection Bio-sample Banks of Malignant Tumors from Digestive System].

    Science.gov (United States)

    Shen, Si; Shen, Junwei; Zhu, Liang; Wu, Chaoqun; Li, Dongliang; Yu, Hongyu; Qiu, Yuanyuan; Zhou, Yi

    2015-11-01

    To establish and manage of multicentral collection bio-sample banks of malignant tumors from digestive system, the paper designed a multicentral management system, established the standard operation procedures (SOPs) and leaded ten hospitals nationwide to collect tumor samples. The biobank has been established for half a year, and has collected 695 samples from patients with digestive system malignant tumor. The clinical data is full and complete, labeled in a unified way and classified to be managed. The clinical and molecular biology researches were based on the biobank, and obtained achievements. The biobank provides a research platform for malignant tumor of digestive system from different regions and of different types.

  7. Case mix planning in hospitals: a review and future agenda.

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    Hof, Sebastian; Fügener, Andreas; Schoenfelder, Jan; Brunner, Jens O

    2017-06-01

    The case mix planning problem deals with choosing the ideal composition and volume of patients in a hospital. With many countries having recently changed to systems where hospitals are reimbursed for patients according to their diagnosis, case mix planning has become an important tool in strategic and tactical hospital planning. Selecting patients in such a payment system can have a significant impact on a hospital's revenue. The contribution of this article is to provide the first literature review focusing on the case mix planning problem. We describe the problem, distinguish it from similar planning problems, and evaluate the existing literature with regard to problem structure and managerial impact. Further, we identify gaps in the literature. We hope to foster research in the field of case mix planning, which only lately has received growing attention despite its fundamental economic impact on hospitals.

  8. The new system of review by multicentre research ethics committees: prospective study.

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    Tully, J; Ninis, N; Booy, R; Viner, R

    2000-04-29

    To assess the function of the new system of review by multicentre research ethics committees and to highlight areas where improvement is still needed. Prospectively collected data from a multicentre study was examined with respect to the ethics review process. Administrative, financial, and time elements of the review process were audited. A single multicentre research ethics committee and 125 local ethics committees from six regions of England. Time to reply, time to approval, and number of non-local changes to the application requested. Only 40% of local ethics committees considered our study in the manner specified in the 1998 directive. Less than a third of committees replied within the 21 day period stipulated, although committees acting by executive subcommittee replied more quickly than those not acting by executive subcommittee. There was a tendency for executive subcommittees to approve studies in a shorter time. Local ethics committees asked for a large number of non-local changes to the application. The financial cost of applying to multiple ethics committees remains high, mainly because multiple copies of research applications are being requested. The new system of approval by multicentre research ethics committee for multicentre studies was introduced to reduce administrative costs, speed up the process of reviews by multiple research ethics committees, and standardise the conclusions of the local research ethics committees. Since its introduction an improvement has been seen, but the system is not yet universally functioning as intended. Ethics review still remains a hindrance to the financial resources and commencement of national studies. We strongly support the structure of review by multicentre research ethics committees but suggest that the system has yet to achieve its aims.

  9. Medicare and Medicaid Programs; CY 2018 Home Health Prospective Payment System Rate Update and CY 2019 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements. Final rule.

    Science.gov (United States)

    2017-11-07

    This final rule updates the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2018. This rule also: Updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking; implements the third year of a 3-year phase-in of a reduction to the national, standardized 60-day episode payment to account for estimated case-mix growth unrelated to increases in patient acuity (that is, nominal case-mix growth) between calendar year (CY) 2012 and CY 2014; and discusses our efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CY 2014 through CY 2017. In addition, this rule finalizes changes to the Home Health Value-Based Purchasing (HHVBP) Model and to the Home Health Quality Reporting Program (HH QRP). We are not finalizing the implementation of the Home Health Groupings Model (HHGM) in this final rule.

  10. A case study evaluation of ethics review systems for multicentre clinical trials.

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    Hicks, Sian C; James, Rebecca E; Wong, Nicole; Tebbutt, Niall C; Wilson, Kate

    2009-09-07

    To evaluate the difference in time taken for ethics and site governance approval for multicentre clinical trials using two different systems of ethics review. We evaluated the times to final ethics and governance approval for two international, multicentre clinical trials of treatment for metastatic colorectal cancer: the MAX trial, using a non-centralised ethics review system, and the CO.20 trial, using the new New South Wales centralised ethics review system. Time from trial submission to overall study approval. The median time taken to obtain ethics approval for the MAX trial at 16 NSW sites was 100 days (range, 36-161 days). The median time to obtain central ethics approval for the CO.20 trial at 14 NSW sites was 77 days, with an additional 60 days (range 20-79 days) required to obtain site-specific research governance approval. Any difference in time to approval between the review systems was outweighed by the overall time taken. However, the time spent by both the coordinating centre and local sites in collation, submission and correspondence was greatly reduced, and the centralised process allowed for standardised documentation at all study sites.

  11. Oral iloprost in Raynaud's phenomenon secondary to systemic sclerosis : A multicentre, placebo-controlled, dose-comparison study

    NARCIS (Netherlands)

    Black, CM; Halkier-Sorensen, L; Belch, JJF; Ullman, S; Madhok, R; Smit, AJ; Banga, JD; Watson, HR

    Objective. To identify the optimal dose of oral iloprost bn the basis of efficacy and tolerability in patients with Raynaud's phenomenon secondary to systemic sclerosis. Design. Multicentre, randomized, parallel-group comparison of two different doses of oral iloprost and placebo. Setting. European

  12. Spatial Analysis of Case-Mix and Dialysis Modality Associations.

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    Phirtskhalaishvili, Tamar; Bayer, Florian; Edet, Stephane; Bongiovanni, Isabelle; Hogan, Julien; Couchoud, Cécile

    2016-01-01

    ♦ Health-care systems must attempt to provide appropriate, high-quality, and economically sustainable care that meets the needs and choices of patients with end-stage renal disease (ESRD). France offers 9 different modalities of dialysis, each characterized by dialysis technique, the extent of professional assistance, and the treatment site. The aim of this study was 1) to describe the various dialysis modalities in France and the patient characteristics associated with each of them, and 2) to analyze their regional patterns to identify possible unexpected associations between case-mixes and dialysis modalities. ♦ The clinical characteristics of the 37,421 adult patients treated by dialysis were described according to their treatment modality. Agglomerative hierarchical cluster analysis was used to aggregate the regions into clusters according to their use of these modalities and the characteristics of their patients. ♦ The gradient of patient characteristics was similar from home hemodialyis (HD) to in-center HD and from non-assisted automated peritoneal dialysis (APD) to assisted continuous ambulatory peritoneal dialysis (CAPD). Analyzing their spatial distribution, we found differences in the patient case-mix on dialysis across regions but also differences in the health-care provided for them. The classification of the regions into 6 different clusters allowed us to detect some unexpected associations between case-mixes and treatment modalities. ♦ The 9 modalities of treatment available make it theoretically possible to adapt treatment to patients' clinical characteristics and abilities. However, although we found an overall appropriate association of dialysis modalities to the case-mix, major inter-region heterogeneity and the low rate of peritoneal dialysis (PD) and home HD suggest that factors besides patients' clinical conditions impact the choice of dialysis modality. The French organization should now be evaluated in terms of patients' quality of

  13. A multicentre study of 513 Danish patients with systemic lupus erythematosus. I. Disease manifestations and analyses of clinical subsets

    DEFF Research Database (Denmark)

    Jacobsen, S; Petersen, J; Ullman, S

    1998-01-01

    cluster (25%) all had malar rash and half were photosensitive. Follow-up showed that the patients of cluster 2 developed azotaemia, large proteinuria, arterial hypertension and myositis significantly more often than did the rest of the patients, but the mortality was not increased. The risk of developing......A Danish multicentre study was undertaken of the manifestations, infections, thrombotic events, survival and predictive factors of survival in 513 Danish patients with systemic lupus erythematosus (SLE) according to the 1982 classification criteria of the American College of Rheumatology. The mean...

  14. A multicentre study of 513 Danish patients with systemic lupus erythematosus. I. Disease manifestations and analyses of clinical subsets

    DEFF Research Database (Denmark)

    Jacobsen, Søren; Petersen, J; Ullman, S

    1998-01-01

    A Danish multicentre study was undertaken of the manifestations, infections, thrombotic events, survival and predictive factors of survival in 513 Danish patients with systemic lupus erythematosus (SLE) according to the 1982 classification criteria of the American College of Rheumatology. The mean...... duration of follow-up was 8.2 years from diagnosis and 12.8 years from first symptom. This paper describes the most common clinical and laboratory manifestations and their relationship to sex and age at the time of onset and diagnosis. Cluster analysis revealed three clinically defined clusters at the time...

  15. Early Lupus Project - A multicentre Italian study on systemic lupus erythematosus of recent onset.

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    Sebastiani, G D; Prevete, I; Piga, M; Iuliano, A; Bettio, S; Bortoluzzi, A; Coladonato, L; Tani, C; Spinelli, F R; Fineschi, I; Mathieu, A

    2015-10-01

    Systemic lupus erythematosus (SLE) is an autoimmune disease with a high degree of variability at onset that is problematic for a correct and prompt diagnosis. We undertook this project with the purpose of collecting an inception cohort of Italian patients with recent-onset SLE, in order to obtain information on the main clinical and serological characteristics at the beginning of the disease. In this first report we describe the characteristics of this cohort at study entry. All patients with a diagnosis of SLE (1997 ACR criteria) and a disease duration less than 12 months were consecutively enrolled between 1 January 2012 and 31 December 2013 in a multicentre prospective study. Information on clinical and serological characteristics at study entry and then every six months was collected into a specific electronic database. Statistical analysis was performed by means of the Openstat program. Among 122 patients enrolled (103 F) 94.3% were Caucasians. Mean age (SD) of patients at study entry was 37.3 (14.3) years, mean age at disease onset was 34.8 (14.3) years, mean age at diagnosis was 36.9 (14.3) years, and mean disease duration was 2.9 (3.9) months. The frequency of the manifestations included in the 1997 ACR criteria was as follows: ANA 97.5%, immunologic disorders (anti-dsDNA, anti-Sm, antiphospholipid antibodies) 85.2%, arthritis 61.8%, haematologic disorders 55.7%, malar rash 31.1%, photosensitivity 29.5%, serositis 27%, renal disorders 27%, oral/nasal ulcers 11.5%, neurologic disorders 8.2%, and discoid rash 5.7%. The cumulative frequency of mucocutaneous symptoms was 77.8%. At enrolment, autoantibody frequency was: ANA 100%, anti-dsDNA 83.6%, anti-SSA 28%, anticardiolipin 24.5%, anti-nRNP 20.4%, anti-beta2GPI 17.2%, lupus anticoagulant 16.3%, anti-Sm 16%, and anti-SSB 13.1%. In this paper we describe the main clinical and serological characteristics of an Italian inception cohort of patients with recent-onset SLE. At disease onset, mucocutaneous

  16. Using case-mix information in strategic hospital marketing. Deriving market research from patient data.

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    Little, A

    1992-01-01

    Hospital survival requires adaptation, adaptation requires understanding, and understanding requires information. These are the basic equations behind hospital strategic marketing, and one of the answers may lie in hospitals' own patient-data systems. Marketers' and administrators' enlightened application of case-mix information could become one more hospital survival tool.

  17. The economic implications of case-mix Medicaid reimbursement for nursing home care.

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    Grabowski, David C

    2002-01-01

    In recent years, there has been large growth in the nursing home industry in the use of case-mix adjusted Medicaid payment systems that employ resident characteristics to predict the relative use of resources in setting payment levels. Little attention has been paid to the access and quality incentives that these systems provide in the presence of excess demand conditions due to certificate-of-need (CON) and construction moratoria. Using 1991 to 1998 panel data for all certified U.S. nursing homes, a fixed-effects model indicates that adoption of a case-mix payment system led to increased access for more dependent residents, but the effect was modified in excess demand markets. Quality remained relatively stable with the introduction of case-mix reimbursement, regardless of the presence of excess demand conditions. These results suggest that CON and construction moratoria are still important barriers within the nursing home market, and recent quality assurance activities related to the introduction of case-mix payment systems may have been effective.

  18. Association between Health Information Technology and Case Mix Index.

    Science.gov (United States)

    Park, Young-Taek; Lee, Junsang; Lee, Jinhyung

    2017-10-01

    Health information technology (IT) can assist healthcare providers in ordering medication and adhering to guidelines while improving communication among providers and the quality of care. However, the relationship between health IT and Case Mix Index (CMI) has not been thoroughly investigated; therefore, this study aimed to clarify this relationship. To examine the effect of health IT on CMI, a generalized estimation equation (GEE) was applied to two years of California hospital data. We found that IT was positively associated with CMI, indicating that increased IT adoption could lead to a higher CMI or billing though DRG up-coding. This implies that hospitals' revenue could increase around $40,000 by increasing IT investment by 10%. The positive association between IT and CMI implies that IT adoption itself could lead to higher patient billings. Generally, a higher CMI in a hospital indicates that the hospital provides expensive services with higher coding and therefore receives more money from patients. Therefore, measures to prevent upcoding through IT systems should be implemented.

  19. Second generation system development and multi-centre studies of the Elements VR-rehab system

    NARCIS (Netherlands)

    Mumford, N.; Shum, D.; Thomas, P.; Steenbergen, B.; Duckworth, J.; Eldridge, R.; Williams, G.P.; Green, D.; Rogers, J.; Caeyenberghs, K.; Wilson, P.H.

    2015-01-01

    Elements is a table-top virtual reality system designed for rehabilitation of upper-limb function in populations with neuro-cognitive deficits. It includes two sets of virtual task environment (VEs). The first are 'goal-directed VEs' whereby participants move tangible user interfaces (TUIs) to

  20. Does Assisted Living Capacity Influence Case Mix at Nursing Homes?

    OpenAIRE

    Clement, Jan P.; Khushalani, Jaya

    2015-01-01

    Assisted living facilities (ALFs) have grown over the past few decades. If they attract residents with lower care needs away from nursing homes (NHs), NHs may be left with higher case mix residents. We study the relationship between ALF bed market capacity and NH case mix in a state (Virginia) where ALF bed capacity stabilized after a period of growth. Similarly, NH capacity and use had been stable. While it is interesting to study markets in flux, for planning purposes, it is also important ...

  1. QuaDoSta - a freely configurable system which facilitates multi-centric data collection for healthcare and medical research

    Directory of Open Access Journals (Sweden)

    Albrecht, Ulrike

    2007-07-01

    Full Text Available This article describes QuaDoSta (quality assurance, documentation and statistics, a flexible documentation system as well as a data collection and networking platform for medical facilities. The user can freely define the required documentation masks which are easily expandable and can be adapted to individual requirements without the need for additional programming. To avoid duplication, data transfer interfaces can be configured flexibly to external sources such as patient management systems used in surgeries or hospital information systems. The projects EvaMed (Evaluation Anthroposophical Medicine and the Network Oncology are two scientific research projects which have been successfully established as nationally active networks on the basis of QuaDoSta. The EvaMed-Network serves as a modern pharmacovigilance project for the documentation of adverse drug events. All prescription data are electronically recorded to assess the relative risk of drugs. The Network Oncology was set up as a documentation system in four hospitals and seven specialist oncology practices where a complete record of all oncological therapies is being carried out to uniform standards on the basis of the ‘basic documentation for tumour patients’ (BDT developed by the German Cancer Society. The QuaDoSta solution system made it possible to cater for the specific requirements of the presented projects. The following features of the system proved to be highly advantageous: flexible setup of catalogues and user friendly customisation and extensions, complete dissociation of system setup and documentation content, multi-centre networkability, and configurable data transfer interfaces.

  2. Does Assisted Living Capacity Influence Case Mix at Nursing Homes?

    Directory of Open Access Journals (Sweden)

    Jan P. Clement PhD

    2015-05-01

    Full Text Available Assisted living facilities (ALFs have grown over the past few decades. If they attract residents with lower care needs away from nursing homes (NHs, NHs may be left with higher case mix residents. We study the relationship between ALF bed market capacity and NH case mix in a state (Virginia where ALF bed capacity stabilized after a period of growth. Similarly, NH capacity and use had been stable. While it is interesting to study markets in flux, for planning purposes, it is also important to examine what happens after periods of turbulence and adaptation. Our findings show some substitution of ALF for NH care, but the relationship is not linear with ALF market capacity. Communities need to consider the interplay of ALFs and NHs in planning for long-term care services and supports. Policies supporting ALFs may enable care needs to be met in a lower cost setting than the NH.

  3. Adjusting for case mix and social class in examining variation in home visits between practices.

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    Sullivan, Caoimhe O; Omar, Rumana Z; Forrest, Christopher B; Majeed, Azeem

    2004-08-01

    The purpose of this study was to investigate whether adjusting for clinical case mix and social class explains more of the variation in home visits between general practices than adjusting for age and sex alone. The setting was 60 general practices in England and Wales taking part in the 1 year Fourth National Morbidity Survey. The participants comprised 349 505 patients who were registered with one of the participating general practices for at least 180 days, and who had at least one consultation during the period. The outcome measure is whether or not a patient received a home visit in that year. A clinical case mix category (morbidity class) based on 1 year's diagnostic information was assigned to each patient using the Johns Hopkins Adjusted Clinical Groups (ACG) Case Mix System. The social class measure was derived from occupation and employment status and is similar to that of the 1991 UK census. Variations in home visits between practices were examined using multilevel logistic regression models. The variability between practices before and after adjusting for clinical case mix and social class was estimated using the intracluster correlation coefficient (ICC). The overall percentage of patients receiving a home visit over the 1 year study period was 17%, and this varied from 7 to 31% across the 60 practices. The percentage of the total variation in home visits attributable to differences between practices was 2.5% [95% confidence interval (CI) 1.4-3.2%] after adjusting for age and sex. This reduced to 1.6% (95% CI 1.1-2.4%) after taking into account morbidity class. The results were similar when social class was included instead of morbidity class. Morbidity and social class together reduced variation in home visits between practices to 1.5% (95% CI 1.1-2.2%). Age, sex, social class and clinical case mix are strong determinants of home visits in the UK. Adjusting for morbidity and social class results in a small improvement in explaining the variability in

  4. Long-term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study.

    Science.gov (United States)

    Friedl, Alexander; Mühlstädt, Sandra; Zachoval, Roman; Giammò, Alessandro; Kivaranovic, Danijel; Rom, Maximilian; Fornara, Paolo; Brössner, Clemens

    2017-05-01

    To evaluate the long-term effectiveness and safety of the adjustable transobturator male system (ATOMS ® , Agency for Medical Innovations A.M.I., Feldkirch, Austria) in a European-wide multicentre setting. In all, 287 men with stress urinary incontinence (SUI) were treated with the ATOMS device between June 2009 and March 2016. Continence parameters (daily pad test/pad use), urodynamics (maximum urinary flow rate, voiding volume, residual urine), and pain/quality of life (QoL) ratings (visual analogue scale/Leeds Assessment of Neuropathic Symptoms and Signs, International Consultation on Incontinence Questionnaire-Short Form [ICIQ-SF]/Patient Global Impression of Improvement [PGI-I]) were compared preoperatively and after intermediate (12 months) as well as after individual maximum follow-up. Overall success rate, dry rate (ATOMS devices are still functioning; 56 (20%) were removed, the most common reason being local titanium intolerance (41%) and leak/dysfunction (30%). The operating time and continence outcome varied between port generations. In this regard the latest port generation (silicone-covered scrotal port) was superior to its predecessors. Primary implantation (P = 0.002), good physical health (P = 0.001), and no history of radiotherapy (P ATOMS device is safe and shows high treatment efficacy and patient satisfaction in the largest cohort study to date. The latest generation, with its pre-attached silicone-covered scrotal port, is superior to its predecessors. Significantly better results were achieved with primary implantation and in those without a history of radiotherapy. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

  5. Development and implementation of a multi-centre information system for paediatric and infant critical care.

    Science.gov (United States)

    Maybloom, Bruce; Champion, Zahra

    2003-12-01

    With no UK collective information system, a need existed to establish an integrated information system for public and private sector hospitals providing paediatric and infant critical care services. A lack of information in the past made it difficult for those procuring, providing and monitoring services to make informed, evidence-based decisions using reliable integrated data. To develop and implement a collective multi-purpose information system for paediatric and infant critical care that was easily adaptable to any UK infant or paediatric critical care setting. Information outputs had to fulfil policy requirements and meet the needs of stakeholders. Two minimum datasets, corresponding data definitions, survey forms and a user database were developed through a process of consultation by utilising an information partnership. Design, content, development and implementation issues were identified, discussed and resolved through a co-ordinated collaborative process. Data collection was implemented in all London and Brighton National Health Service (NHS) general and cardio-thoracic paediatric intensive care (PIC) units, several private PIC units and one NHS tertiary referral neonatal unit (NNU) 24 months from project start. The development of universal integrated information systems for defined settings of care is achievable within reasonable timeframes; however, successful development and implementation requires working within an information partnership to maximise co-ordination, co-operation and collaboration. Those collecting and using data must be identified and involved in all aspects of development from project start. Financial and manpower resources must be well planned. Datasets should be as small as possible in order to make the collection of complete and valid data realistically achievable. When considering service-based information needs, considerable thought should be given to a multi-purpose; multi-use approach based on the most refined minimum dataset

  6. Multicentric lupus vulgaris

    Directory of Open Access Journals (Sweden)

    Ramachandra S

    1995-01-01

    Full Text Available A 60 year old female patient presented with disseminated tuberculosis. She had multicentric lupus vulgaris and her joints, bones, lymph nodes and lungs were also affected. Haematogenous dissemination was because of her poor health.

  7. Knowledge of medical students on National Health Care System: A French multicentric survey.

    Science.gov (United States)

    Feral-Pierssens, A-L; Jannot, A-S

    2017-09-01

    Education on national health care policy and costs is part of our medical curriculum explaining how our health care system works. Our aim was to measure French medical students' knowledge about national health care funding, costs and access and explore association with their educational and personal background. We developed a web-based survey exploring knowledge on national health care funding, access and costs through 19 items and measured success score as the number of correct answers. We also collected students' characteristics and public health training. The survey was sent to undergraduate medical students and residents from five medical universities between July and November 2015. A total of 1195 students from 5 medical universities responded to the survey. Most students underestimated the total amount of annual medical expenses, hospitalization costs and the proportion of the general population not benefiting from a complementary insurance. The knowledge score was not associated with medical education level. Three students' characteristics were significantly associated with a better knowledge score: male gender, older age, and underprivileged status. Medical students have important gaps in knowledge regarding national health care funding, coverage and costs. This knowledge was not associated with medical education level but with some of the students' personal characteristics. All these results are of great concern and should lead us to discussion and reflection about medical and public health training. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  8. Determinants of unemployment amongst Australian systemic sclerosis patients: results from a multicentre cohort study.

    Science.gov (United States)

    Morrisroe, Kathleen; Huq, Molla; Stevens, Wendy; Rabusa, Candice; Proudman, Susanna M; Nikpour, Mandana

    2016-01-01

    We sought to assess employment status, risk factors for unemployment and the associations of unemployment with patients' health related quality of life (HRQoL). All patients enrolled in a systemic sclerosis (SSc) longitudinal cohort study, completed an employment questionnaire on enrolment. Clinical manifestations were defined based on presence at the time of enrolment. Summary statistics, chi-square tests, univariate and multivariable logistic regression were used to determine the associations of various risk factors with employment. Among 1587 SSc patients, 160 (20%) were unemployed at the time of cohort enrolment excluding retired patients. Of these, 63% had limited disease subtype. Mean (±SD) age at enrollment was 51.9 (±10.4) years; 13 years below the average retirement age in Australia. Mean (±SD) disease duration at recruitment was 11.1 (±10.9) years. Multivariable regression analysis revealed the presence of digital amputation (OR 3.9, 95%CI 1.7-9.1, p=0.002), diffuse disease subtype (OR 2.2, 95%CI 1.3-3.5, p-value=0.002), sicca symptoms (OR 2.7, 95%CI 1.6-4.4, punemployment. Unemployed patients had consistently poorer HRQoL scores in all domains (physical, emotional and mental health) of the SF-36 form than those who were employed. SSc is associated with substantial work disability and unemployment, which is in turn associated with poor quality of life. Raising awareness, identifying modifiable risk factors and implementing employment strategies and work place modifications are possible ways of reducing this burden.

  9. Suboptimal management of central nervous system infections in children: a multi-centre retrospective study

    Directory of Open Access Journals (Sweden)

    Kelly Christine

    2012-09-01

    Full Text Available Abstract Objective We aimed to audit the regional management of central nervous system (CNS infection in children. Methods The study was undertaken in five district general hospitals and one tertiary paediatric hospital in the Mersey region of the UK. Children admitted to hospital with a suspected CNS infection over a three month period were identified. Children were aged between 4 weeks and 16 years old. Details were recorded from the case notes and electronic records. We measured the appropriateness of management pathways as outlined by national and local guidelines. Results Sixty-five children were identified with a median age of 6 months (range 1 month to 15 years. Ten had a CNS infection: 4 aseptic meningitis, 3 purulent meningitis, 3 encephalitis [2 with herpes simplex virus (HSV type 1]. A lumbar puncture (LP was attempted in 50 (77% cases but only 43 had cerebrospinal fluid (CSF available for analysis. Of these 24 (57% had a complete standard set of tests performed. Fifty eight (89% received a third generation cephalosporin. Seventeen (26% also received aciclovir with no obvious indication in 9 (53%. Only 11 (65% of those receiving aciclovir had CSF herpes virus PCR. Seventeen had cranial imaging and it was the first management step in 14. Treatment lengths of both antibiotics and aciclovir were highly variable: one child with HSV encephalitis was only treated with aciclovir for 7 days. Conclusions The clinical management of children with suspected CNS infections across the Mersey region is heterogeneous and often sub-optimal, particularly for the investigation and treatment of viral encephalitis. National guidelines for the management of viral encephalitis are needed.

  10. FDG-PET/CT findings in systemic mastocytosis: a French multicentre study

    Energy Technology Data Exchange (ETDEWEB)

    Djelbani-Ahmed, S. [Assistance Publique - Hopitaux de Paris (APHP), Department of Nuclear Medicine, Avicenne Hospital, Bobigny (France); Paris 13 University, Sorbonne Paris Cite, Bobigny (France); Chandesris, M.O. [Necker Children' s Hospital, APHP, French Reference center for Mastocytosis (Centre de Reference des Mastocytoses, CEREMAST), Paris (France); Necker Children' s Hospital, APHP, Department of Haematology, Paris (France); Paris Descartes University, Sorbonne Paris Cite, Imagine Institute, Paris (France); Mekinian, A.; Fain, O. [Saint Antoine Hospital, Department of Internal Medicine and Inflammation-Immunopathology-Biotherapy Department (DHU i2B), AP-HP, Paris (France); Canioni, D. [Necker Children' s Hospital, APHP, French Reference center for Mastocytosis (Centre de Reference des Mastocytoses, CEREMAST), Paris (France); Paris Descartes University, Sorbonne Paris Cite, Imagine Institute, Paris (France); Necker Children' s Hospital, APHP, Department of Pathology, Paris (France); Brouzes, C. [Necker Children' s Hospital, APHP, French Reference center for Mastocytosis (Centre de Reference des Mastocytoses, CEREMAST), Paris (France); Paris Descartes University, Sorbonne Paris Cite, Imagine Institute, Paris (France); Necker Children' s Hospital, APHP, Laboratory of Haematology, Paris (France); Hanssens, K. [Necker Children' s Hospital, APHP, French Reference center for Mastocytosis (Centre de Reference des Mastocytoses, CEREMAST), Paris (France); Aix-Marseille University, INSERM U1068, Centre de Recherche en Cancerologie de Marseille (Signaling, Hematopoiesis and Mechanism of Oncogenesis), Paoli Calmettes Institute, Marseille (France); Pop, G.; Eder, V. [Assistance Publique - Hopitaux de Paris (APHP), Department of Nuclear Medicine, Avicenne Hospital, Bobigny (France); Durieu, I.; Durupt, S. [Universite de Lyon, Department of Internal and Vascular Medicine, Hospices Civils de Lyon, Groupe Hopitalier Sud, Pierre-Benite (France); Grosbois, B.; Besnard, S. [Rennes University Hospital, Department of Internal Medicine, Rennes (France); Tournilhac, O. [Clermont-Ferrand University Hospital, Department of Internal Medicine, Clermont-Ferrand (France); Beyne-Rauzy, O. [Purpan University Hospital, Department of Internal Medicine, Toulouse (France); Agape, P. [Saint-Denis University Hospital, Department of Oncology and Haematology, Saint-Denis de la Reunion (France); Delmer, A. [Reims University Hospital, Department of Haematology, Reims (France); Ranta, D. [Brabois University Hospital, Department of Haematology, Vandoeuvre les Nancy (France); Jeandel, P.Y. [Nice University Hospital, Department of Internal Medicine, Nice (France); Georgin-Lavialle, S. [Tenon Hospital, Department of Internal Medicine, Paris (France); Frenzel, L.; Hermine, O. [Necker Children' s Hospital, APHP, French Reference center for Mastocytosis (Centre de Reference des Mastocytoses, CEREMAST), Paris (FR); Necker Children' s Hospital, APHP, Department of Haematology, Paris (FR); Paris Descartes University, Sorbonne Paris Cite, Imagine Institute, Paris (FR); Damaj, G. [Necker Children' s Hospital, APHP, French Reference center for Mastocytosis (Centre de Reference des Mastocytoses, CEREMAST), Paris (FR); Caen University Hospital, Department of Haematology, Caen (FR); Lortholary, O. [Necker Children' s Hospital, APHP, French Reference center for Mastocytosis (Centre de Reference des Mastocytoses, CEREMAST), Paris (FR); Paris Descartes University, Sorbonne Paris Cite, Imagine Institute, Paris (FR); Pasteur Institute, Department of Infectious Diseases and Tropical Medicine, Necker Children' s Hospital, APHP, Paris (FR); Soussan, M. [Assistance Publique - Hopitaux de Paris (APHP), Department of Nuclear Medicine, Avicenne Hospital, Bobigny (FR); Paris 13 University, Sorbonne Paris Cite, Bobigny (FR)

    2015-12-15

    Mastocytosis is a clonal haematological disease characterized by uncontrolled proliferation and the activation of mast cells. The value of FDG-PET/CT (FDG-PET) in mastocytosis has yet to be determined. We retrospectively identified patients with an established diagnosis of systemic mastocytosis (SM), according to the WHO criteria, who underwent PET using the French Reference Centre for Mastocytosis database. Semi-quantitative and visual analysis of FDG-PET was performed and compared to the clinico-biological data. Our cohort included 19 adult patients, median age 65 years [range 58-74], including three with smouldering SM (SSM), three with aggressive SM (ASM), 10 with an associated clonal haematological non-mast-cell lineage disease (SM-AHNMD), and three with mast cell sarcoma (MCS). FDG-PET was performed at the time of the SM diagnosis (15/19), to evaluate lymph node (LN) activity (3/19) or the efficacy of therapy (1/19). FDG uptake was observed in the bone marrow (BM) (9/19, 47 %), LN (6/19, 32 %), spleen (12/19, 63 %), or liver (1/19, 5 %). No significant FDG uptake was observed in the SSM and ASM patients. A pathological FDG uptake was observed in the BM of 6/10 patients with SM-AHNMD, appearing as diffuse and homogeneous, and in the LN of 5/10 patients. All 3 MCS patients showed intense and multifocal BM pathological uptake, mimicking metastasis. No correlation was found between the FDG-PET findings and serum tryptase levels, BM mast cell infiltration percentage, and CD30 and CD2 expression by mast cells. FDG uptake does not appear to be a sensitive marker of mast cell activation or proliferation because no significant FDG uptake was observed in most common forms of mastocytosis (notably purely aggressive SM). However, pathological FDG uptake was observed in the SM-AHNMD and in MCS cases, suggesting a role of FDG-PET in their early identification and as a tool of therapeutic assessment in this subgroup of patients. (orig.)

  11. FDG-PET/CT findings in systemic mastocytosis: a French multicentre study

    International Nuclear Information System (INIS)

    Djelbani-Ahmed, S.; Chandesris, M.O.; Mekinian, A.; Fain, O.; Canioni, D.; Brouzes, C.; Hanssens, K.; Pop, G.; Eder, V.; Durieu, I.; Durupt, S.; Grosbois, B.; Besnard, S.; Tournilhac, O.; Beyne-Rauzy, O.; Agape, P.; Delmer, A.; Ranta, D.; Jeandel, P.Y.; Georgin-Lavialle, S.; Frenzel, L.; Hermine, O.; Damaj, G.; Lortholary, O.; Soussan, M.

    2015-01-01

    Mastocytosis is a clonal haematological disease characterized by uncontrolled proliferation and the activation of mast cells. The value of FDG-PET/CT (FDG-PET) in mastocytosis has yet to be determined. We retrospectively identified patients with an established diagnosis of systemic mastocytosis (SM), according to the WHO criteria, who underwent PET using the French Reference Centre for Mastocytosis database. Semi-quantitative and visual analysis of FDG-PET was performed and compared to the clinico-biological data. Our cohort included 19 adult patients, median age 65 years [range 58-74], including three with smouldering SM (SSM), three with aggressive SM (ASM), 10 with an associated clonal haematological non-mast-cell lineage disease (SM-AHNMD), and three with mast cell sarcoma (MCS). FDG-PET was performed at the time of the SM diagnosis (15/19), to evaluate lymph node (LN) activity (3/19) or the efficacy of therapy (1/19). FDG uptake was observed in the bone marrow (BM) (9/19, 47 %), LN (6/19, 32 %), spleen (12/19, 63 %), or liver (1/19, 5 %). No significant FDG uptake was observed in the SSM and ASM patients. A pathological FDG uptake was observed in the BM of 6/10 patients with SM-AHNMD, appearing as diffuse and homogeneous, and in the LN of 5/10 patients. All 3 MCS patients showed intense and multifocal BM pathological uptake, mimicking metastasis. No correlation was found between the FDG-PET findings and serum tryptase levels, BM mast cell infiltration percentage, and CD30 and CD2 expression by mast cells. FDG uptake does not appear to be a sensitive marker of mast cell activation or proliferation because no significant FDG uptake was observed in most common forms of mastocytosis (notably purely aggressive SM). However, pathological FDG uptake was observed in the SM-AHNMD and in MCS cases, suggesting a role of FDG-PET in their early identification and as a tool of therapeutic assessment in this subgroup of patients. (orig.)

  12. Stroke rehabilitation outcome variation in Veterans Affairs rehabilitation units: accounting for case-mix.

    Science.gov (United States)

    Reker, D M; O'Donnell, J C; Hamilton, B B

    1998-07-01

    To assess variation in stroke outcomes and create a case-mix adjustment model for stroke rehabilitation in Veterans Affairs Medical Centers. Observational Within Veteran's Health Administration hospitals, there are 63 acute rehabilitation bedservice units that care for approximately 2,000 stroke patients annually. Functional gain in FIM points, length of stay (LOS), LOS efficiency (FIM gain/LOS). Significant variation in average patient functional gain, LOS, and LOS efficiency was observed among the 37 highest-volume rehabilitation units. Using analysis of covariance, a model was developed that adjusted functional gain and LOS (logged LOS) unit means using 10 potential covariates identified in a literature review and in pilot studies. Four and six covariates, respectively, were retained in the final models for FIM gain and LOS. The R2 for FIM gain and LOS accounted for by rehabilitation unit alone increased from .07 to .31 (FIM gain) and from .13 to .34 (logLOS) with the addition of the significant covariates to each model. As much as 24% of the variation in two important stroke rehabilitation outcomes is attributable to largely immutable patient and system characteristics (eg, patient function on admission, age, days since stroke onset, year of discharge, marital status, and referral source). Hence, controlling for case-mix is critical for accurate comparison of unit outcomes. Further, the variation in LOS efficiency between VA rehabilitation units suggests a large potential for cost and resource utilization savings system-wide.

  13. Changes in diagnostic case mix in psychiatric care in general hospitals, 1980-85.

    Science.gov (United States)

    Kiesler, C A; Simpkins, C

    1992-05-01

    The Hospital Discharge Survey of 1980 and 1985 was used to assess changes in diagnostic case mix of psychiatric inpatient care in short-term, nonfederal general hospitals. Information regarding presence of psychiatric and chemical dependency units was added to both surveys, and information regarding exemption from Medicare's PPS system was noted for 1985. The largest increase was in ICD-9 code 296 (affective disorder), which more than doubled in frequency, along with a similar decrease in Diagnosis-Related Group 426, depressive neurosis. One explanation for this sizable shift was "gaming the system." One cannot conclusively, however, distinguish between gaming the system and the effects of changing professional views of depression during this time period. Other variables potentially contributing to the effect are described as well.

  14. Atypical multicentric reticulohistiocytosis

    Directory of Open Access Journals (Sweden)

    Mittal R

    1998-01-01

    Full Text Available A 38-year-old male had arthritis since 8 years and erythematous papules, plaques, cutaneous and subcutaneous nodules over face, ears, trunk, and extensors of arms since 2 years, Histopathologically, presence of multiple foreign body giant cells confirmed the clinical diagnosis of multicentric reticulohistiocytosis. Unusual associations were: tapered fingers with depressed scars on their tips, low ESR - (5mm 1st hour. Raynaud′s phenomenon and exaggeration of lesions after methotrexate.

  15. Performance of the BacT/Alert Virtuo Microbial Detection System for the culture of sterile body fluids: prospective multicentre study.

    Science.gov (United States)

    She, R C; Romney, M G; Jang, W; Walker, T; Karichu, J K; Richter, S S

    2017-12-20

    Continuous monitoring blood culture systems are commonly used for sterile body fluid cultures. In this multicentre study, we evaluated the performance of the new-generation BacT/Alert Virtuo system compared to the BacT/Alert 3D and conventional culture for the recovery of microorganisms from sterile body fluids. Peritoneal, cerebrospinal, pericardial, pleural and synovial fluids from adult patients submitted for culture were collected from three different centres. Specimens were inoculated into two bottles of the same bottle type (SA, SN, FA Plus or FN Plus) in equal volumes for simultaneous incubation in the Virtuo and 3D instruments. Each specimen was also Gram stained and seeded to solid media. A total of 811 specimens were inoculated to 1257 bottle pairs. The Virtuo and 3D showed equivalent recovery of clinically significant microorganisms (127/155, 81.9%, vs. 126/155, 81.3%, respectively). Solid media cultures recovered fewer pathogens than either continuous monitoring system (95/155, 61.3%, p culture but showed faster detection of growth as a result of design enhancements. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

  16. Multicentric Castleman's Disease in a Child Revealed by Chronic Diarrhea.

    Science.gov (United States)

    Benmiloud, Sarra; Chaouki, Sana; Atmani, Samir; Hida, Moustapha

    2015-01-01

    Multicentric Castleman's disease is a rare benign and unexplained lymphoproliferative disorder that is extremely uncommon in children. It presents with fever, systemic symptoms, generalized lymphadenopathy, and laboratory markers of inflammation. Its treatment is not standardized and its prognosis is poor. We report a novel case of multicentric Castleman's disease in a 13-year-old girl who had presented with chronic diarrhea as the only initial presenting symptom. The diagnosis of celiac or inflammatory bowel diseases was suspected, but two and a half years later, the diagnosis of multicentric Castleman's disease was brought following the appearance of abdominal mass whose biopsy revealed Castleman's disease in the plasma cell form. The outcome was favorable after treatment by corticosteroid, chemotherapy, and surgery. The occurrence of diarrhea as the initial symptom of multicentric Castleman's disease without lymph node involvement is very rare. This case report underlines the diagnostic difficulties and the long interval between onset and diagnosis when diarrhea occurs first.

  17. Definition of a multicentral bond index

    International Nuclear Information System (INIS)

    Giambiagi, M.; Giambiagi, M.S. de; Mundim, K.C.

    1989-01-01

    The tensor character of the first-order density matrix leads to the definition of an MO multicentral bond index for closed-shell systems. It is here applied to three-center bonds. Satisfactory results are obtained for compounds involving 'secondary' bonds, strong and normal hydrogen bonds; the index for the peptide bond is found to be similar to that of strong hydrogen bonds. (author) [pt

  18. Optimisation and validation of a remote monitoring system (Onco-TreC) for home-based management of oral anticancer therapies: an Italian multicentre feasibility study.

    Science.gov (United States)

    Passardi, Alessandro; Rizzo, Mimma; Maines, Francesca; Tondini, Carlo; Zambelli, Alberto; Vespignani, Roberto; Andreis, Daniele; Massa, Ilaria; Dianti, Marco; Forti, Stefano; Piras, Enrico Maria; Eccher, Claudio

    2017-05-29

    Despite the growing number of oral agents available for cancer treatment, their efficacy may be reduced due to the lack of adherence, inappropriate adverse event self-management and arbitrary dose adjustment. The management of anticancer therapies could exponentially benefit from the introduction of mobile health technologies in a highly integrated electronic oncology system. We plan to customise and fine-tune an existing monitoring TreC platform used in different chronic diseases in the oncology setting. This project follows a multistep approach with two major purposes: 1. participatory design techniques driven by Health Literacy and Patient Reported Outcomes principles in order to adapt the system to the oncology setting involving patients and healthcare providers; 2. a prospective training-validation, interventional, non-pharmacological, multicentre study on a series of consecutive patients with cancer (20 and 60 patients in the training and validation steps, respectively) in order to assess system capability, usability and acceptability. The novel Onco-TreC 2.0 is expected to contribute to improving the adherence and safety of cancer care, promoting patient empowerment and patient-doctor communication. Ethical approval was obtained from the Independent Ethics Committees of the participating institutions (CEIIAV protocol Number 2549/2015; reference Number 1315-PU). Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations. ClinicalTrials.gov (NCT02921724); (Pre-results). Other study ID Number: IRST100.18. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  19. Compassionate use of the PASCAL transcatheter mitral valve repair system for patients with severe mitral regurgitation: a multicentre, prospective, observational, first-in-man study.

    Science.gov (United States)

    Praz, Fabien; Spargias, Konstantinos; Chrissoheris, Michael; Büllesfeld, Lutz; Nickenig, Georg; Deuschl, Florian; Schueler, Robert; Fam, Neil P; Moss, Robert; Makar, Moody; Boone, Robert; Edwards, Jeremy; Moschovitis, Aris; Kar, Saibal; Webb, John; Schäfer, Ulrich; Feldman, Ted; Windecker, Stephan

    2017-08-19

    Severe mitral regurgitation is associated with impaired prognosis if left untreated. Using the devices currently available, transcatheter mitral valve repair (TMVr) remains challenging in complex anatomical situations. We report the procedural and 30-day results of the first-in-man study of the Edwards PASCAL TMVr system. In this multicentre, prospective, observational, first-in-man study, we collected data from seven tertiary care hospitals in five countries that had a compassionate use programme in which patients underwent transcatheter mitral valve repair using the Edwards PASCAL TMVr system. Eligible patients were those with symptomatic, severe functional, degenerative, or mixed mitral regurgitation deemed at high risk or inoperable. Safety and efficacy of the procedure were prospectively assessed at device implantation, discharge, and 30 days after device implantation. The key study endpoints were technical success assessed at the end of the procedure and device success 30 days after implantation using the Mitral Valve Academic Research Consortium definitions. Between Sept 1, 2016, and March 31, 2017, 23 patients (median age 75 years [IQR 61-82]) had treatment for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the Edwards PASCAL TMVr system. At baseline, the median EuroScore II score was 7·1% (IQR 3·6-12·8) and the median Society of Thoracic Surgeons predicted risk of mortality for mitral valve repair was 4·8% (2·1-9·0) and 6·8% (2·9-10·1) for mitral valve replacement. 22 (96%) of 23 patients were New York Heart Association (NYHA) class III or IV at baseline. The implantation of at least one device was successful in all patients, resulting in procedural residual mitral regurgitation of grade 2+ or less in 22 (96%) patients. Six (26%) of 23 patients had two implants. Periprocedural complications occurred in two (9%) of 23 patients (one minor bleeding event and one transient ischaemic attack). Despite the anatomical

  20. Reliability assessment of AOSpine thoracolumbar spine injury classification system and Thoracolumbar Injury Classification and Severity Score (TLICS) for thoracolumbar spine injuries: results of a multicentre study.

    Science.gov (United States)

    Kaul, Rahul; Chhabra, Harvinder Singh; Vaccaro, Alexander R; Abel, Rainer; Tuli, Sagun; Shetty, Ajoy Prasad; Das, Kali Dutta; Mohapatra, Bibhudendu; Nanda, Ankur; Sangondimath, Gururaj M; Bansal, Murari Lal; Patel, Nishit

    2017-05-01

    The aim of this multicentre study was to determine whether the recently introduced AOSpine Classification and Injury Severity System has better interrater and intrarater reliability than the already existing Thoracolumbar Injury Classification and Severity Score (TLICS) for thoracolumbar spine injuries. Clinical and radiological data of 50 consecutive patients admitted at a single centre with a diagnosis of an acute traumatic thoracolumbar spine injury were distributed to eleven attending spine surgeons from six different institutions in the form of PowerPoint presentation, who classified them according to both classifications. After time span of 6 weeks, cases were randomly rearranged and sent again to same surgeons for re-classification. Interobserver and intraobserver reliability for each component of TLICS and new AOSpine classification were evaluated using Fleiss Kappa coefficient (k value) and Spearman rank order correlation. Moderate interrater and intrarater reliability was seen for grading fracture type and integrity of posterior ligamentous complex (Fracture type: k = 0.43 ± 0.01 and 0.59 ± 0.16, respectively, PLC: k = 0.47 ± 0.01 and 0.55 ± 0.15, respectively), and fair to moderate reliability (k = 0.29 ± 0.01 interobserver and 0.44+/0.10 intraobserver, respectively) for total score according to TLICS. Moderate interrater (k = 0.59 ± 0.01) and substantial intrarater reliability (k = 0.68 ± 0.13) was seen for grading fracture type regardless of subtype according to AOSpine classification. Near perfect interrater and intrarater agreement was seen concerning neurological status for both the classification systems. Recently proposed AOSpine classification has better reliability for identifying fracture morphology than the existing TLICS. Additional studies are clearly necessary concerning the application of these classification systems across multiple physicians at different level of training and trauma centers to evaluate not

  1. Rural and Urban Differences in Vocational Rehabilitation Case Mix, Delivery Practices, and Employment Outcomes

    Science.gov (United States)

    Ipsen, Catherine; Swicegood, Grant

    2015-01-01

    Purpose: To examine rural and urban differences in Vocational Rehabilitation (VR) case mix, delivery practices, and employment outcomes. Methods: Rehabilitation Services Administration 911 (RSA-911) case data do not include location indicators that allow for rural analyses. We compiled RSA-911 data with county and ZIP code information from 47 VR…

  2. The operating room case-mix problem under uncertainty and nurses capacity constraints.

    Science.gov (United States)

    Yahia, Zakaria; Eltawil, Amr B; Harraz, Nermine A

    2016-12-01

    Surgery is one of the key functions in hospitals; it generates significant revenue and admissions to hospitals. In this paper we address the decision of choosing a case-mix for a surgery department. The objective of this study is to generate an optimal case-mix plan of surgery patients with uncertain surgery operations, which includes uncertainty in surgery durations, length of stay, surgery demand and the availability of nurses. In order to obtain an optimal case-mix plan, a stochastic optimization model is proposed and the sample average approximation method is applied. The proposed model is used to determine the number of surgery cases to be weekly served, the amount of operating rooms' time dedicated to each specialty and the number of ward beds dedicated to each specialty. The optimal case-mix selection criterion is based upon a weighted score taking into account both the waiting list and the historical demand of each patient category. The score aims to maximizing the service level of the operating rooms by increasing the total number of surgery cases that could be served. A computational experiment is presented to demonstrate the performance of the proposed method. The results show that the stochastic model solution outperforms the expected value problem solution. Additional analysis is conducted to study the effect of varying the number of ORs and nurses capacity on the overall ORs' performance.

  3. Levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation (Novasure) in women with heavy menstrual bleeding: a multicentre randomised controlled trial

    NARCIS (Netherlands)

    Herman, Malou C.; van den Brink, Marian J.; Geomini, Peggy M.; van Meurs, Hannah S.; Huirne, Judith A.; Eising, Heleen P.; Timmermans, Anne; Pijnenborg, Johanna M. A.; Klinkert, Ellen R.; Coppus, Sjors F.; Nieboer, Theodoor E.; Catshoek, Ruby; van der Voet, Lucet F.; van Eijndhoven, Hugo W. F.; Graziosi, Giuseppe C. M.; Veersema, Sebastiaan; van Kesteren, Paul J.; Langenveld, Josje; Smeets, Nicol A. C.; van Vliet, Huib A. A. M.; van der Steeg, Jan Willem; Lisman-van Leeuwen, Yvonne; Dekker, Janny H.; Mol, Ben W.; Berger, Marjolein Y.; Bongers, Marlies Y.

    2013-01-01

    Heavy menstrual bleeding is an important health problem. Two frequently used therapies are the levonorgestrel intra-uterine system (LNG-IUS) and endometrial ablation. The LNG-IUS can be applied easily by the general practitioner, which saves costs, but has considerable failure rates. As an

  4. Levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation (Novasure) in women with heavy menstrual bleeding : a multicentre randomised controlled trial

    NARCIS (Netherlands)

    Herman, Malou C.; van den Brink, Marian; Geomini, Peggy M.; van Meurs, Hannah S.; Huirne, Judith A.; Eising, Heleen P.; Timmermans, Anne; Pijnenborg, Johanna M. A.; Klinkert, Ellen R.; Coppus, Sjors F.; Nieboer, Theodoor E.; Catshoek, Ruby; van der Voet, Lucet F.; van Eijndhoven, Hugo W. F.; Graziosi, Giuseppe C. M.; Veersema, Sebastiaan; van Kesteren, Paul J.; Langenveld, Josje; Smeets, Nicol A. C.; van Vliet, Huib A. A. M.; van der Steeg, Jan Willem; Lisman-van Leeuwen, Yvonne; Dekker, Janny H.; Mol, Ben W.; Berger, Marjolein Y.; Bongers, Marlies Y.

    2013-01-01

    Background: Heavy menstrual bleeding is an important health problem. Two frequently used therapies are the levonorgestrel intra-uterine system (LNG-IUS) and endometrial ablation. The LNG-IUS can be applied easily by the general practitioner, which saves costs, but has considerable failure rates. As

  5. Paediatric case mix in a rural clinical school is relevant to future practice.

    Science.gov (United States)

    Wright, Helen M; Maley, Moira A L; Playford, Denese E; Nicol, Pam; Evans, Sharon F

    2017-11-29

    Exposure to a representative case mix is essential for clinical learning, with logbooks established as a way of demonstrating patient contacts. Few studies have reported the paediatric case mix available to geographically distributed students within the same medical school. Given international interest in expanding medical teaching locations to rural contexts, equitable case exposure in rural relative to urban settings is topical. The Rural Clinical School of Western Australia locates students up to 3500 km from the urban university for an academic year. There is particular need to examine paediatric case mix as a study reported Australian graduates felt unprepared for paediatric rotations. We asked: Does a rural clinical school provide a paediatric case mix relevant to future practice? How does the paediatric case mix as logged by rural students compare with that by urban students? The 3745 logs of 76 urban and 76 rural consenting medical students were categorised by presenting symptoms and compared to the Australian Institute of Health and Welfare (AIHW) database Major Diagnostic Categories (MDCs). Rural and urban students logged core paediatric cases, in similar order, despite the striking difference in geographic locations. The pattern of overall presenting problems closely corresponded to Australian paediatric hospital admissions. Rural students logged 91% of cases in secondary healthcare settings; urban students logged 90% of cases in tertiary settings. The top four presenting problems were ENT/respiratory, gastrointestinal/urogenital, neurodevelopmental and musculoskeletal; these made up 60% of all cases. Rural and urban students logged similar proportions of infants, children and adolescents, with a variety of case morbidity. Rural clinical school students logged a mix of core paediatric cases relevant to illnesses of Australian children admitted to public hospitals, with similar order and pattern by age group to urban students, despite major differences

  6. The Nephrocare project: referral, patient case-mix, follow-up and quality of renal care in Nordic renal centres

    DEFF Research Database (Denmark)

    Bergrem, H.; Goransson, L.G.; Asmundsson, P.

    2009-01-01

    OBJECTIVE: Few studies have focused on patients actually attending renal units for their follow-up over time. This study reports the type of prevalent patients (case-mix) with a renal condition being followed up by 19 renal units in the Nordic countries during 1998-99. MATERIAL AND METHODS......: In a joint quality of care development project between the renal societies of the five Nordic countries and the unit for Quality of Health Systems, WHO (Europe), 19 renal units collected data on a random sample of their prevalent patients. RESULTS: At follow-up, 56% had chronic kidney disease (CKD...... prescribed an angiotensin-inhibiting drug. CONCLUSIONS: The data, collected in 1998-99, indicate that there is room for improvement in the quality of care provided by renal units to patients with CKD. The data may serve as a basis for assessing possible change in nephrological practice after the introduction...

  7. Measuring performance in health care: case-mix adjustment by boosted decision trees.

    Science.gov (United States)

    Neumann, Anke; Holstein, Josiane; Le Gall, Jean-Roger; Lepage, Eric

    2004-10-01

    The purpose of this paper is to investigate the suitability of boosted decision trees for the case-mix adjustment involved in comparing the performance of various health care entities. First, we present logistic regression, decision trees, and boosted decision trees in a unified framework. Second, we study in detail their application for two common performance indicators, the mortality rate in intensive care and the rate of potentially avoidable hospital readmissions. For both examples the technique of boosting decision trees outperformed standard prognostic models, in particular linear logistic regression models, with regard to predictive power. On the other hand, boosting decision trees was computationally demanding and the resulting models were rather complex and needed additional tools for interpretation. Boosting decision trees represents a powerful tool for case-mix adjustment in health care performance measurement. Depending on the specific priorities set in each context, the gain in predictive power might compensate for the inconvenience in the use of boosted decision trees.

  8. The Pediatric Home Care/Expenditure Classification Model (P/ECM: A Home Care Case-Mix Model for Children Facing Special Health Care Challenges

    Directory of Open Access Journals (Sweden)

    Charles D. Phillips

    2015-01-01

    Full Text Available Case-mix classification and payment systems help assure that persons with similar needs receive similar amounts of care resources, which is a major equity concern for consumers, providers, and programs. Although health service programs for adults regularly use case-mix payment systems, programs providing health services to children and youth rarely use such models. This research utilized Medicaid home care expenditures and assessment data on 2,578 children receiving home care in one large state in the USA. Using classification and regression tree analyses, a case-mix model for long-term pediatric home care was developed. The Pediatric Home Care/Expenditure Classification Model (P/ECM grouped children and youth in the study sample into 24 groups, explaining 41% of the variance in annual home care expenditures. The P/ECM creates the possibility of a more equitable, and potentially more effective, allocation of home care resources among children and youth facing serious health care challenges.

  9. Resection of the primary tumour versus no resection prior to systemic therapy in patients with colon cancer and synchronous unresectable metastases (UICC stage IV): SYNCHRONOUS - a randomised controlled multicentre trial (ISRCTN30964555)

    International Nuclear Information System (INIS)

    Rahbari, Nuh N; Koch, Moritz; Büchler, Markus W; Kieser, Meinhard; Weitz, Jürgen; Lordick, Florian; Fink, Christine; Bork, Ulrich; Stange, Annika; Jäger, Dirk; Luntz, Steffen P; Englert, Stefan; Rossion, Inga

    2012-01-01

    Currently, it remains unclear, if patients with colon cancer and synchronous unresectable metastases who present without severe symptoms should undergo resection of the primary tumour prior to systemic chemotherapy. Resection of the primary tumour may be associated with significant morbidity and delays the beginning of chemotherapy. However, it may prevent local symptoms and may, moreover, prolong survival as has been demonstrated in patients with metastatic renal cell carcinoma. It is the aim of the present randomised controlled trial to evaluate the efficacy of primary tumour resection prior to systemic chemotherapy to prolong survival in patients with newly diagnosed colon cancer who are not amenable to curative therapy. The SYNCHRONOUS trial is a multicentre, randomised, controlled, superiority trial with a two-group parallel design. Colon cancer patients with synchronous unresectable metastases are eligible for inclusion. Exclusion criteria are primary tumour-related symptoms, inability to tolerate surgery and/or systemic chemotherapy and history of another primary cancer. Resection of the primary tumour as well as systemic chemotherapy is provided according to the standards of the participating institution. The primary endpoint is overall survival that is assessed with a minimum follow-up of 36 months. Furthermore, it is the objective of the trial to assess the safety of both treatment strategies as well as quality of life. The SYNCHRONOUS trial is a multicentre, randomised, controlled trial to assess the efficacy and safety of primary tumour resection before beginning of systemic chemotherapy in patients with metastatic colon cancer not amenable to curative therapy. http://www.controlled-trials.com/ISRCTN30964555

  10. Nontrauma emergency surgery: optimal case mix for general surgery and acute care surgery training.

    Science.gov (United States)

    Cherry-Bukowiec, Jill R; Miller, Barbra S; Doherty, Gerard M; Brunsvold, Melissa E; Hemmila, Mark R; Park, Pauline K; Raghavendran, Krishnan; Sihler, Kristen C; Wahl, Wendy L; Wang, Stewart C; Napolitano, Lena M

    2011-11-01

    To examine the case mix and patient characteristics and outcomes of the nontrauma emergency (NTE) service in an academic Division of Acute Care Surgery. An NTE service (attending, chief resident, postgraduate year-3 and postgraduate year-2 residents, and two physician assistants) was created in July 2005 for all urgent and emergent inpatient and emergency department general surgery patient consults and admissions. An NTE database was created with prospective data collection of all NTE admissions initiated from November 1, 2007. Prospective data were collected by a dedicated trauma registrar and Acute Physiology and Chronic Health Evaluation-intensive care unit (ICU) coordinator daily. NTE case mix and ICU characteristics were reviewed for the 2-year time period January 1, 2008, through December 31, 2009. During the same time period, trauma operative cases and procedures were examined and compared with the NTE case mix. Thousand seven hundred eight patients were admitted to the NTE service during this time period (789 in 2008 and 910 in 2009). Surgical intervention was required in 70% of patients admitted to the NTE service. Exploratory laparotomy or laparoscopy was performed in 449 NTE patients, comprising 37% of all surgical procedures. In comparison, only 118 trauma patients (5.9% of admissions) required a major laparotomy or thoracotomy during the same time period. Acuity of illness of NTE patients was high, with a significant portion (13%) of NTE patients requiring ICU admission. NTE patients had higher admission Acute Physiology and Chronic Health Evaluation III scores [61.2 vs. 58.8 (2008); 58.2 vs. 55.8 (2009)], increased mortality [(9.71% vs. 4.89% (2008); 6.78% vs. 5.16% (2009)], and increased readmission rates (15.5% vs. 7.4%) compared with the total surgical ICU (SICU) admissions. In an era of declining operative caseload in trauma, the NTE service provides ample opportunity for complex general surgery decision making and operative procedures for

  11. 76 FR 68525 - Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2012

    Science.gov (United States)

    2011-11-04

    ... removes two hypertension codes from the HH PPS case-mix system, thereby requiring recalibration of the... to Comments A. Case-Mix Measurement B. Case-Mix Revision to the Case-Mix Weights 1. Hypertension... ``Confined to the Home'' Definition III. Collection of Information Requirements IV. Regulatory Impact...

  12. Multicentric Castleman's disease & HIV infection.

    LENUS (Irish Health Repository)

    Cotter, A

    2009-10-01

    We report the case of a 35 year patient from Nigeria who presented with fever and splenomegaly. The initial diagnosis was Salmonellosis. However, relapsing symptoms lead to a re-evaluation and ultimately a diagnosis of Multicentric Castleman\\'s Disease (MCD). There is no gold standard treatment but our patient responded to Rituximab and Highly active anti-retroviral therapy. MCD is a rare, aggressive disease that should be considered in a HIV positive patient presenting with fever and significant lymphadenopathy.

  13. Epidemiological multicentre study on the education provided to patients with type 2 diabetes mellitus in the Spanish Health Care System. The Forma2 study.

    Science.gov (United States)

    García-Donaire, J A; Franch-Nadal, J; Rodríguez-Fortúnez, P; Labrador-Barba, E; Orera-Peña, M L; Rodríguez de Miguel, M

    The purpose of the present study was to characterize the education that patients with type 2 diabetes mellitus receive, and to identify differences as regards the presence of insulin therapy or not. This crossover, multicentre and descriptive study involved 1066 Spanish physicians who completed a questionnaire on Internet. The physicians that responded had a mean of 26.0 years of experience in healthcare, and mainly worked in a walk-in clinic in an urban area. Physicians rated the level of patient knowledge about their disease on a 5.0 point-scale. Fifty percent of them indicated that they spent between 15 and 30min in educating patients at the time of diagnosis. Previous control with HbA1c>9%, presence of microvascular complications, and a low socio-cultural level, were factors associated with spending more time in education. This is the first study designed to evaluate the education provided to patients with type 2 diabetes mellitus from Spain. The time spent and the individualization of the education are important factors associated with better long-term control of the disease, and thus with the effectiveness of the clinical management. Copyright © 2017 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.

  14. Case-mix tool, costs and effectiveness in improving primary care mental health and substance abuse services.

    Science.gov (United States)

    Riihimäki, Kirsi; Heiska-Johansson, Ainomaija; Ketola, Eeva

    2018-02-01

    Despite its importance in improving care and developing services, high-quality data evaluating cost-effectiveness and services in different case-mix populations is scarce in primary care. The objective was to investigate the service use of those mental health and substance abuse patients, who use lots of services. Primary health care diagnosis-related groups (pDRG) is a tool to evaluate service provider system and improve efficiency, productivity and quality. We viewed all pDRG results available from the year 2015 concerning municipal mental health and substance abuse services. In primary care mental health and substance abuse services, the most common ICD-10-codes were depression and substance abuse. One-fifth of patients produced 57% of costs. Their medium of appointments was 16 per year versus 6 per year of all patients. Only 54% of their diagnoses were recorded in the electronic health records versus 75% of all patients. They made 5.7 different pDRG episodes, including 1.8 episodes of depression, per patient. The average episode cost for this patient group was 301€. pDRG makes health care production transparent also in mental health and substance abuse services. It is easy to identify patients, who use a lot of services and thus induce the majority of costs, and focus on their needs in managing and developing services.

  15. The Nephrocare project: referral, patient case-mix, follow-up and quality of renal care in Nordic renal centres

    DEFF Research Database (Denmark)

    Bergrem, H.; Goransson, L.G.; Asmundsson, P.

    2009-01-01

    OBJECTIVE: Few studies have focused on patients actually attending renal units for their follow-up over time. This study reports the type of prevalent patients (case-mix) with a renal condition being followed up by 19 renal units in the Nordic countries during 1998-99. MATERIAL AND METHODS......: In a joint quality of care development project between the renal societies of the five Nordic countries and the unit for Quality of Health Systems, WHO (Europe), 19 renal units collected data on a random sample of their prevalent patients. RESULTS: At follow-up, 56% had chronic kidney disease (CKD......) not in renal replacement therapy (RRT). Seventeen per cent had haemodialysis (HD), 6% peritoneal dialysis (PD) and 21% a functioning kidney transplant (Tx). In the CKD group, 5.9% were CKD stage 1, 17.6% stage 2, 35.2% stage 3, 25.6% stage 4 and 15.7% stage 5. One-third had known cardiovascular disease, 30...

  16. The use of the BDA Case Mix Model to assess the need for referral of patients to specialist dental services.

    Science.gov (United States)

    AlKindi, N A; Nunn, J

    2016-04-22

    Access to health services is a right for every individual. However, there is evidence that people with disabilities face barriers in accessing dental health. One of the reasons associated with this is the unclear referral pathway existing in the Irish dental health service. The appropriate assignment of patients to relevant services is an important issue to ensure better access to healthcare. This is all the more pertinent because there are only a few trained dental practitioners to provide dental treatment for people with disabilities, as well as even fewer qualified specialists in special care dentistry. The aim of this part of the study was to assess the use of the BDA Case Mix Model to determine the need for referral of patients to specialist dental services, and to determine any association between patient complexity and the need for adjunct measures, such as sedation and general anaesthesia for the management of people with disabilities and complex needs. A retrospective analysis of dental records using the BDA Case Mix Model.Results The results showed that patients with different levels of complexities were being referred to the special care dentistry clinic at the Dublin Dental University Hospital. The results also showed that the need for supportive adjunct measures such as sedation and general anaesthesia was not necessarily the main reason for referring patients to specialist services. The assessment with the BDA Case Mix Model was comprehensive as it looked at many factors contributing to the cases' complexity. Not all categories in the Case Mix Model had significant association with the need for an adjunct.Conclusion The BDA Case Mix Model can be used to measure the need for supportive adjunct measures, such as sedation and general anaesthesia.

  17. Asymptomatic population reference values for three knee patient-reported outcomes measures: evaluation of an electronic data collection system and implications for future international, multi-centre cohort studies.

    Science.gov (United States)

    McLean, James M; Brumby-Rendell, Oscar; Lisle, Ryan; Brazier, Jacob; Dunn, Kieran; Gill, Tiffany; Hill, Catherine L; Mandziak, Daniel; Leith, Jordan

    2018-05-01

    The aim was to assess whether the Knee Society Score, Oxford Knee Score (OKS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) were comparable in asymptomatic, healthy, individuals of different age, gender and ethnicity, across two remote continents. The purpose of this study was to establish normal population values for these scores using an electronic data collection system. There is no difference in clinical knee scores in an asymptomatic population when comparing age, gender and ethnicity, across two remote continents. 312 Australian and 314 Canadian citizens, aged 18-94 years, with no active knee pain, injury or pathology in the ipsilateral knee corresponding to their dominant arm, were evaluated. A knee examination was performed and participants completed an electronically administered questionnaire covering the subjective components of the knee scores. The cohorts were age- and gender-matched. Chi-square tests, Fisher's exact test and Poisson regression models were used where appropriate, to investigate the association between knee scores, age, gender, ethnicity and nationality. There was a significant inverse relationship between age and all assessment tools. OKS recorded a significant difference between gender with females scoring on average 1% lower score. There was no significant difference between international cohorts when comparing all assessment tools. An electronic, multi-centre data collection system can be effectively utilized to assess remote international cohorts. Differences in gender, age, ethnicity and nationality should be taken into consideration when using knee scores to compare to pathological patient scores. This study has established an electronic, normal control group for future studies using the Knee society, Oxford, and KOOS knee scores. Diagnostic Level II.

  18. Why are urban hospital costs so high? The relative importance of patient source of admission, teaching, competition, and case mix.

    OpenAIRE

    Thorpe, K E

    1988-01-01

    This article examines factors accounting for higher costs in urban hospitals as well as their relative contribution to those costs. The costs of urban hospitals are influenced by case mix, wages, competition, the ratio of forecasted to actual admissions, teaching, and the percentage of patients admitted through the emergency room. The bulk of the higher costs in urban hospitals are linked to graduate medical education. Treatment of poor patients and the admission of patients through the emerg...

  19. Hypercalcaemic multicentric lymphoma in a dog presenting as clitoromegaly

    Directory of Open Access Journals (Sweden)

    Anthony B. Zambelli

    2013-12-01

    Full Text Available Clitoromegaly is a clinical manifestation of various local and systemic conditions in all species. The external genitalia are a very rare site of primary or metastatic lymphoma in canines, with only one previously-reported case in a dog and only sparse reports in the medical literature. Lymphoma is also very rare in dogs less than four years of age. This account reports on a T-cell multicentric lymphoma in a 16-month-old Basset hound presented primarily for clitoromegaly. The patient survived for 68 days with cyclophosphamide-vincristine-prednisolone therapy. The causes of clitoromegaly in all species, including humans, are tabulated with references.

  20. Multi-centric universal pseudonymisation for secondary use of the EHR.

    Science.gov (United States)

    Lo Iacono, Luigi

    2007-01-01

    This paper discusses the importance of protecting the privacy of patient data kept in an Electronic Health Record (EHR) in the case, where it leaves the control- and protection-sphere of the health care realm for secondary uses such as clinical or epidemiological research projects, health care research, assessment of treatment quality or economic assessments. The paper focuses on multi-centric studies, where various data sources are linked together using Grid technologies. It introduces a pseudonymisation system which enables a multi-centric universal pseudonymisation, meaning that a patient's identity will result in the same pseudonym, regardless of which participating study center the patient data is collected.

  1. Evaluation of several ultrasonography scoring systems for synovitis and comparison to clinical examination: results from a prospective multicentre study of rheumatoid arthritis.

    Science.gov (United States)

    Dougados, Maxime; Jousse-Joulin, Sandrine; Mistretta, Frederic; d'Agostino, Maria-Antonietta; Backhaus, Marina; Bentin, Jacques; Chalès, Gérard; Chary-Valckenaere, Isabelle; Conaghan, Philip; Etchepare, Fabien; Gaudin, Philippe; Grassi, Walter; van der Heijde, Désirée; Sellam, Jérémie; Naredo, Esperanza; Szkudlarek, Marcin; Wakefield, Richard; Saraux, Alain

    2010-05-01

    To evaluate different global ultrasonographic (US) synovitis scoring systems as potential outcome measures of rheumatoid arthritis (RA) according to the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) filter. To study selected global scoring systems, for the clinical, B mode and power Doppler techniques, the following joints were evaluated: 28 joints (28-joint Disease Activity Score (DAS28)), 20 joints (metacarpophalangeals (MCPs) + metatarsophalangeals (MTPs)) and 38 joints (28 joints + MTPs) using either a binary (yes/no) or a 0-3 grade. The study was a prospective, 4-month duration follow-up of 76 patients with RA requiring anti-tumour necrosis factor (TNF) therapy (complete follow-up data: 66 patients). Intraobserver reliability was evaluated using the intraclass correlation coefficient (ICC), construct validity was evaluated using the Cronbach alpha test and external validity was evaluated using level of correlation between scoring system and C reactive protein (CRP). Sensitivity to change was evaluated using the standardised response mean. Discriminating capacity was evaluated using the standardised mean differences in patients considered by the doctor as significantly improved or not at the end of the study. Different clinimetric properties of various US scoring systems were at least as good as the clinical scores with, for example, intraobserver reliability ranging from 0.61 to 0.97 versus from 0.53 to 0.82, construct validity ranging from 0.76 to 0.89 versus from 0.76 to 0.88, correlation with CRP ranging from 0.28 to 0.34 versus from 0.28 to 0.35 and sensitivity to change ranging from 0.60 to 1.21 versus from 0.96 to 1.36 for US versus clinical scoring systems, respectively. This study suggests that US evaluation of synovitis is an outcome measure at least as relevant as physical examination. Further studies are required in order to achieve optimal US scoring systems for monitoring patients with RA in clinical trials and in clinical

  2. Multicentric Chemodectomata at High Altitude | Nathanson | South ...

    African Journals Online (AJOL)

    Multicentric chemodectomata in the right glomus intravagale and both carotid bodies were excised from a 74year-old woman. These are rare tumours. The patient was born and lived at an altitude of 1 800 m above sea level. The effects of altitude and chronic hypoxia on the carotid bodies are discussed.

  3. Treating KSHV-Associated Multicentric Castleman Disease

    Science.gov (United States)

    In this study, patients with KSHV-associated multicentric Castleman disease will receive IV tocilizumab every other week for up to 12 weeks. Patients who do not benefit may go on to receive high-dose AZT and valganciclovir as well.

  4. Corticosteroid contact allergy: an EECDRG multicentre study

    DEFF Research Database (Denmark)

    Dooms-Goossens, A; Andersen, Klaus Ejner; Brandäo, F M

    1996-01-01

    This article describes the results of an EECDRG multicentre study on contact allergy to corticosteroids. A total of 7238 patients were investigated: 6238 in 13 centres in the course of 1993, and 1000 patients in 1 centre in 1993 and 1994. The 5 corticosteroids tested were budesonide 0.1% pet...

  5. Clinical evaluation of a novel dental implant system as single implants under immediate loading conditions - 4-month post-loading results from a multicentre randomised controlled trial.

    Science.gov (United States)

    Esposito, Marco; Trullenque-Eriksson, Anna; Blasone, Rodolfo; Malaguti, Giuliano; Gaffuri, Cristiano; Caneva, Marco; Minciarelli, Armando; Luongo, Giuseppe

    To evaluate the safety and clinical effectiveness of a novel dental implant system (GENESIS Implant System, Keystone Dental, Massachusetts, USA) using another dental implant system by the same manufacturer as a control (PRIMA Implant System, Keystone Dental). A total of 53 patients requiring at least two single crowns had their sites randomised according to a split-mouth design to receive both implant systems at six centres. If implants could be placed with a torque superior to 40 Ncm they were to be loaded immediately with provisional crowns, otherwise after 3 months of submerged healing. Provisional crowns were replaced by definitive crowns 4 months after initial loading, when the follow-up period for the initial part of this study was completed. Outcome measures were crown/implant failures, complications, pink esthetic score (PES), peri-implant marginal bone level changes, plaque score, marginal bleeding, patients and preference of the clinician. In total 53 PRIMA and 53 GENESIS implants were placed. Three patients dropped out but all of the remaining patients were followed up to 4-months post-loading. No PRIMA implant failed whereas four GENESIS implants failed. Only two complications were reported for PRIMA implants. There were no statistically significant differences for crown/implant failures (difference in proportions = 0.080; P (McNemar test) = 0.125) and complications (difference in proportions = -0.04; P (McNemar test) = 0.500) between the implant systems. There were no differences at 4-months post-loading for plaque (difference = -0.54, 95% CI: -3.01 to 1.93; P (Paired t-test) = 0.660), marginal bleeding (difference = -3.8, 95% CI: -7.63 to 0.019; P (Paired t-test) = 0.051), PES (difference = 0.47, 95% CI: -0.56 to 1.50; P (Paired t-test) = 0.365) and marginal bone level changes (difference in mm = -0.04, 95% CI: -0.33 to 0.26; P (Paired t-test) = 0.795). The majority of the patients (46) had no

  6. Harmonizing SUVs in multicentre trials when using different generation PET systems: prospective validation in non-small cell lung cancer patients

    Energy Technology Data Exchange (ETDEWEB)

    Lasnon, Charline; Quak, Elske [Francois Baclesse Cancer Centre, Nuclear Medicine Department, Caen (France); Desmonts, Cedric [Caen University Hospital, Nuclear Medicine Department, Caen (France); Gervais, Radj; Do, Pascal; Dubos-Arvis, Catherine [Francois Baclesse Cancer Centre, Thoracic Oncology, Caen (France); Aide, Nicolas [Francois Baclesse Cancer Centre, Nuclear Medicine Department, Caen (France); Centre Francois Baclesse, Service de Medecine Nucleaire, Caen cedex 5 (France)

    2013-07-15

    We prospectively evaluated whether a strategy using point spread function (PSF) reconstruction for both diagnostic and quantitative analysis in non-small cell lung cancer (NSCLC) patients meets the European Association of Nuclear Medicine (EANM) guidelines for harmonization of quantitative values. The NEMA NU-2 phantom was used to determine the optimal filter to apply to PSF-reconstructed images in order to obtain recovery coefficients (RCs) fulfilling the EANM guidelines for tumour positron emission tomography (PET) imaging (PSF{sub EANM}). PET data of 52 consecutive NSCLC patients were reconstructed with unfiltered PSF reconstruction (PSF{sub allpass}), PSF{sub EANM} and with a conventional ordered subset expectation maximization (OSEM) algorithm known to meet EANM guidelines. To mimic a situation in which a patient would undergo pre- and post-therapy PET scans on different generation PET systems, standardized uptake values (SUVs) for OSEM reconstruction were compared to SUVs for PSF{sub EANM} and PSF{sub allpass} reconstruction. Overall, in 195 lesions, Bland-Altman analysis demonstrated that the mean ratio between PSF{sub EANM} and OSEM data was 1.03 [95 % confidence interval (CI) 0.94-1.12] and 1.02 (95 % CI 0.90-1.14) for SUV{sub max} and SUV{sub mean}, respectively. No difference was noticed when analysing lesions based on their size and location or on patient body habitus and image noise. Ten patients (84 lesions) underwent two PET scans for response monitoring. Using the European Organization for Research and Treatment of Cancer (EORTC) criteria, there was an almost perfect agreement between OSEM{sub PET1}/OSEM{sub PET2} (current standard) and OSEM{sub PET1}/PSF{sub EANM-PET2} or PSF{sub EANM-PET1}/OSEM{sub PET2} with kappa values of 0.95 (95 % CI 0.91-1.00) and 0.99 (95 % CI 0.96-1.00), respectively. The use of PSF{sub allpass} either for pre- or post-treatment (i.e. OSEM{sub PET1}/PSF{sub allpass-PET2} or PSF{sub allpass-PET1}/OSEM{sub PET2}) showed

  7. Is RoAsT tougher than StEAk?: The effect of case mixing on perception of multi-letter graphemes

    Directory of Open Access Journals (Sweden)

    Jelena Havelka

    2010-03-01

    Full Text Available Case mixing is a technique that is used to investigate the perceptual processes involved in visual word recognition. Two experiments examined the effect of case mixing on lexical decision latencies. The aim of these experiments was to establish whether different case mixing patterns would interact with the process of appropriate visual segmentation and phonological assembly in word reading. In the first experiment, case mixing had a greater effect on response times to words when it led to visual disruption of the multi-letter graphemes (MLGs as well as the overall word shape (e.g. pLeAd, compared to when it disrupted overall word shape only (e.g. plEAd. A second experiment replicated this finding with words in which MLGs represent either the vowel (e.g. bOaST vs. bOAst or the consonant sound (e.g. sNaCK vs. sNAcK. These results confirm that case mixing can have different effect depending on the type of orthographic unit that is broken up by the manipulation. They demonstrate that graphemes are units that play an important role in visual word recognition, and that manipulation of their presentation by case mixing will have a significant effect on response latencies to words in a lexical decision task. As such these findings need to be taken into account by the models of visual word recognition.

  8. [Systemic Antimicrobials Consumption and Expenditures in Departments of Surgery of Multi-Profile Hospitals in the Russian Federation and the Republic of Belarus: Results of Multicentre Pharmacoepidemiological Study].

    Science.gov (United States)

    Belkova, Yu A; Rachina, S A; Kozlov, R S; Mishchenko, V M; Pavlukov, R A; Abubakirova, A I; Berezhanskiy, B V; Eliseeva, E V; Zubareva, N A; Karpov, I A; Kopylova, I A; Palyutin, Sh Kh; Portnyagina, U S; Pribytkova, O V; Samuylo, E K

    2016-01-01

    The results of the systemic antimicrobials (AM) consumption and expenditures assessment in the departments of surgery of multi-profile hospitals in different regions of the Russian Federation and the Republic of Belarus in 2009-2010 based on retrospective collection and analysis of the data from the hospital expenditure notes using ATC/DDD methodology are presented. The average AM consumption and expenditure rates in the above mentioned departments varied from 24.9 DDD/100 bed-days to 61.7 DDD/100 bed-days depending on the department profile, with beta-lactams (cephalosporins and penicillins) share in the consumption being as high as 70-90%, followed by fluoroquinolones and aminoglycosides. Only 55-70% of the consumed AM belonged to the drugs of choice, whereas the improper AM consumption and expenditure rates amounted up to 10-18%. The study outputs can be used for the budget allocation and AM distribution improvement in the departments of surgery, as well as for the development and efficacy control of the local antimicrobial stewardship programs.

  9. Treatment of Children With Central Nervous System Primitive Neuroectodermal Tumors/Pinealoblastomas in the Prospective Multicentric Trial HIT 2000 Using Hyperfractionated Radiation Therapy Followed by Maintenance Chemotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Gerber, Nicolas U., E-mail: nicolas.gerber@kispi.uzh.ch [Department of Pediatric Oncology, University Children' s Hospital, Zurich (Switzerland); Hoff, Katja von; Resch, Anika [Department of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Ottensmeier, Holger [Department of Pediatric Oncology, University of Wuerzburg, Wuerzburg (Germany); Kwiecien, Robert; Faldum, Andreas [Institute of Biostatistics and Clinical Research, University of Muenster (Germany); Matuschek, Christiane [Department of Radiation Oncology, Medical Faculty, Heinrich Heine University of Duesseldorf, Duesseldorf (Germany); Hornung, Dagmar [Department of Radiotherapy and Radio-Oncology, University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Bremer, Michael [Institute for Radiation Therapy and Special Oncology, Hannover Medical School, Hannover (Germany); Benesch, Martin [Division of Pediatric Hematology and Oncology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Graz (Austria); Pietsch, Torsten [Department of Neuropathology, University of Bonn, Bonn (Germany); Warmuth-Metz, Monika [Department of Neuroradiology, University of Wuerzburg, Wuerzburg (Germany); Kuehl, Joachim [Department of Pediatric Oncology, University of Wuerzburg, Wuerzburg (Germany); Rutkowski, Stefan [Department of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Kortmann, Rolf D. [Department of Radiation Oncology, University of Leipzig, Leipzig (Germany)

    2014-07-15

    Purpose: The prognosis for children with central nervous system primitive neuroectodermal tumor (CNS-PNET) or pinealoblastoma is still unsatisfactory. Here we report the results of patients between 4 and 21 years of age with nonmetastatic CNS-PNET or pinealoblastoma diagnosed from January 2001 to December 2005 and treated in the prospective GPOH-trial P-HIT 2000-AB4. Methods and Materials: After surgery, children received hyperfractionated radiation therapy (36 Gy to the craniospinal axis, 68 Gy to the tumor region, and 72 Gy to any residual tumor, fractionated at 2 × 1 Gy per day 5 days per week) accompanied by weekly intravenous administration of vincristine and followed by 8 cycles of maintenance chemotherapy (lomustine, cisplatin, and vincristine). Results: Twenty-six patients (15 with CNS-PNET; 11 with pinealoblastoma) were included. Median age at diagnosis was 11.5 years old (range, 4.0-20.7 years). Gross total tumor resection was achieved in 6 and partial resection in 16 patients (indistinct, 4 patients). Median follow-up of the 15 surviving patients was 7.0 years (range, 5.2-10.0 years). The combined response rate to postoperative therapy was 17 of 20 (85%). Eleven of 26 patients (42%; 7 of 15 with CNS-PNET; 4 of 11 with pinealoblastoma) showed tumor progression or relapse at a median time of 1.3 years (range, 0.5-1.9 years). Five-year progression-free and overall survival rates (±standard error [SE]) were each 58% (±10%) for the entire cohort: CNS-PNET was 53% (±13); pinealoblastoma was 64% (±15%; P=.524 and P=.627, respectively). Conclusions: Postoperative hyperfractionated radiation therapy with local dose escalation followed by maintenance chemotherapy was feasible without major acute toxicity. Survival rates are comparable to those of a few other recent studies but superior to those of most other series, including the previous trial, HIT 1991.

  10. Multicentric Castleman’s Disease in a Child Revealed by Chronic Diarrhea

    Directory of Open Access Journals (Sweden)

    Sarra Benmiloud

    2015-01-01

    Full Text Available Multicentric Castleman’s disease is a rare benign and unexplained lymphoproliferative disorder that is extremely uncommon in children. It presents with fever, systemic symptoms, generalized lymphadenopathy, and laboratory markers of inflammation. Its treatment is not standardized and its prognosis is poor. We report a novel case of multicentric Castleman’s disease in a 13-year-old girl who had presented with chronic diarrhea as the only initial presenting symptom. The diagnosis of celiac or inflammatory bowel diseases was suspected, but two and a half years later, the diagnosis of multicentric Castleman’s disease was brought following the appearance of abdominal mass whose biopsy revealed Castleman’s disease in the plasma cell form. The outcome was favorable after treatment by corticosteroid, chemotherapy, and surgery. The occurrence of diarrhea as the initial symptom of multicentric Castleman’s disease without lymph node involvement is very rare. This case report underlines the diagnostic difficulties and the long interval between onset and diagnosis when diarrhea occurs first.

  11. Planning, budgeting, and controlling--one look at the future: case-mix cost accounting.

    Science.gov (United States)

    Thompson, J D; Averill, R F; Fetter, R B

    1979-01-01

    This paper outlines the system for cost accounting and managerial control which is an extension of the usually accepted departmental costing systems and takes as its units the 383 Diagnosis Related Groups (DRGs) considered to be the hospital's products. It is held that such an approach offers hospital managers a more powerful, analytic, budgeting, and cost-finding tool and offers the opportunity to involve the medical staff in the issues of how their practice patterns are affecting hospital costs.

  12. [Rehabilitation management categories. A new approach to case mix in medical rehabilitation].

    Science.gov (United States)

    Spyra, K; Müller-Fahrnow, W

    1998-06-01

    Creating typical treatment case groups in medical rehabilitation, in short: Rehabilitee Management Categories (RMKs, Rehabilitanden-Management-Kategorien), is a key issue for quality assurance within the frame of modern concepts of Total Quality Management (TQM), not least utilizing current organization and management concepts (Managed Care). So far, the problem of creating highly homogeneous case groups has remained unsolved on the basis of the present methodological framework. Critical prerequisites for any further scientific work on this problem are being established in the field of medical rehabilitation with the help of the Classification of Therapeutic Services (CTS) as well as development of instruments documenting therapy plans for typical rehabilitation case groups, process-relevant quality features and definitions of therapy goals as a basis for quality screening under the Pension Insurance quality assurance programme in medical rehabilitation. These developments have clearly contributed to expanding the theoretical foundations as well as the prerequisites for empirical grounding of Rehabilitee Management Categories in medical rehabilitation under the Pension Insurance scheme. A project for determination of rehabilitation case groups which is based on these developments, is due to start at the Humboldt University and Technical University, Berlin in the near future within a rehab promotion initiative of the German Pension Insurance system in cooperation with the Federal Ministry of Research and Technology. Conceptually, the determination of Rehabilitee Management Categories by far exceeds all previous approaches as (1) it will be generated by an iterative process of empirical service descriptions and theoretical consensus building among experts, (2) not only static parameters but also process-related details will be recorded, and (3) quality requirements will be defined for the rehabilitation process and outcome. As a result, rehabilitation-relevant case

  13. Case-mix and the use of control charts in monitoring mortality rates after coronary artery bypass

    Directory of Open Access Journals (Sweden)

    Mohammed Mohammed A

    2007-04-01

    Full Text Available Abstract Background There is debate about the role of crude mortality rates and case-mix adjusted mortality rates in monitoring the outcomes of treatment. In the context of quality improvement a key purpose of monitoring is to identify special cause variation as this type of variation should be investigated to identify possible causes. This paper investigates agreement between the identification of special cause variation in risk adjusted and observed hospital specific mortality rates after coronary artery bypass grafting in New York hospitals. Methods Coronary artery bypass grafting mortality rates between 1994 and 2003 were obtained from the New York State Department of Health's cardiovascular reports for 41 hospitals. Cross-sectional control charts of crude (observed and risk adjusted mortality rates were produced for each year. Special cause variation was defined as a data point beyond the 99.9% probability limits: hospitals showing special cause variation were identified for each year. Longitudinal control charts of crude (observed and risk adjusted mortality rates were produced for each hospital with data for all ten years (n = 27. Special cause variation was defined as a data point beyond 99.9% probability limits, two out of three consecutive data points beyond 95% probability limits (two standard deviations from the mean or a run of five consecutive points on one side of the mean. Years showing special cause variation in mortality were identified for each hospital. Cohen's Kappa was calculated for agreement between special causes identified in crude and risk-adjusted control charts. Results In cross sectional analysis the Cohen's Kappa was 0.54 (95% confidence interval: 0.28 to 0.78, indicating moderate agreement between the crude and risk-adjusted control charts with sensitivity 0.4 (95% confidence interval 0.17–0.69 and specificity 0.98 (95% confidence interval: 0.95–0.99. In longitudinal analysis, the Cohen's Kappa was 0.61 (95

  14. Productivity growth, case mix and optimal size of hospitals. A 16-year study of the Norwegian hospital sector.

    Science.gov (United States)

    Anthun, Kjartan Sarheim; Kittelsen, Sverre Andreas Campbell; Magnussen, Jon

    2017-04-01

    This paper analyses productivity growth in the Norwegian hospital sector over a period of 16 years, 1999-2014. This period was characterized by a large ownership reform with subsequent hospital reorganizations and mergers. We describe how technological change, technical productivity, scale efficiency and the estimated optimal size of hospitals have evolved during this period. Hospital admissions were grouped into diagnosis-related groups using a fixed-grouper logic. Four composite outputs were defined and inputs were measured as operating costs. Productivity and efficiency were estimated with bootstrapped data envelopment analyses. Mean productivity increased by 24.6% points from 1999 to 2014, an average annual change of 1.5%. There was a substantial growth in productivity and hospital size following the ownership reform. After the reform (2003-2014), average annual growth was productivity growth as around time of the reform. This study addresses the issues of both cross-sectional and longitudinal comparability of case mix between hospitals, and thus provides a framework for future studies. The study adds to the discussion on optimal hospital size. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. Impact of Case Mix Severity on Quality Improvement in a Patient-centered Medical Home (PCMH) in the Maryland Multi-Payor Program.

    Science.gov (United States)

    Khanna, Niharika; Shaya, Fadia T; Chirikov, Viktor V; Sharp, David; Steffen, Ben

    2016-01-01

    We present data on quality of care (QC) improvement in 35 of 45 National Quality Forum metrics reported annually by 52 primary care practices recognized as patient-centered medical homes (PCMHs) that participated in the Maryland Multi-Payor Program from 2011 to 2013. We assigned QC metrics to (1) chronic, (2) preventive, and (3) mental health care domains. The study used a panel data design with no control group. Using longitudinal fixed-effects regressions, we modeled QC and case mix severity in a PCMH. Overall, 35 of 45 quality metrics reported by 52 PCMHs demonstrated improvement over 3 years, and case mix severity did not affect the achievement of quality improvement. From 2011 to 2012, QC increased by 0.14 (P Quality Assurance PCMH level was associated with higher QC for the mental health care domain, whereas case mix severity did not correlate with QC. In multivariate analyses, higher QC correlated with larger practices, greater proportion of older patients, and readmission visits. Rural practices had higher proportions of Medicaid patients, lower QC, and higher QC improvement in interaction analyses with time. The gains in QC in the chronic disease domain, the preventive care domain, and, most significantly, the mental health care domain were observed over time regardless of patient case mix severity. QC improvement was generally not modified by practice characteristics, except for rurality. © Copyright 2016 by the American Board of Family Medicine.

  16. A multi-centre dosimetry audit on advanced radiotherapy in lung as part of the Isotoxic IMRT study

    Directory of Open Access Journals (Sweden)

    Yat Tsang

    2017-10-01

    Conclusion: This multi-centre dosimetry audit of complex IMRT/VMAT delivery provides confidence in the accuracy of modern planning and delivery systems in inhomogeneous tissues. The findings from this study can be used as a reference for future dosimetry audits.

  17. Case-mix and quality indicators in Chinese elder care homes: are there differences between government-owned and private-sector facilities?

    Science.gov (United States)

    Liu, Chang; Feng, Zhanlian; Mor, Vincent

    2014-02-01

    To assess the association between ownership of Chinese elder care facilities and their performance quality and to compare the case-mix profile of residents and facility characteristics in government-owned and private-sector homes. Cross-sectional study. Census of elder care homes surveyed in Nanjing (2009) and Tianjin (2010). Elder care facilities located in urban Nanjing (n = 140, 95% of all) and urban Tianjin (n = 157, 97% of all). A summary case-mix index based on activity of daily living (ADL) limitations and cognitive impairment was created to measure levels of care needs of residents in each facility. Structure, process, and outcome measures were selected to assess facility-level quality of care. A structural quality measure, understaffing relative to resident levels of care needs, which indicates potentially inadequate staffing given resident case-mix, was also developed. Government-owned homes had significantly higher occupancy rates, presumably reflecting popular demand for publicly subsidized beds, but served residents who, on average, have fewer ADL and cognitive functioning limitations than those in private-sector facilities. Across a range of structure, process, and outcome measures of quality, there is no clear evidence suggesting advantages or disadvantages of either ownership type, although when staffing-to-resident ratio is gauged relative to resident case-mix, private-sector facilities were more likely to be understaffed than government-owned facilities. In Nanjing and Tianjin, private-sector homes were more likely to be understaffed, although their residents were sicker and frailer on average than those in government facilities. It is likely that the case-mix differences are the result of selective admission policies that favor healthier residents in government facilities than in private-sector homes. © 2014, Copyright the Authors Journal compilation © 2014, The American Geriatrics Society.

  18. Design and internal validation of an obstetric early warning score: secondary analysis of the Intensive Care National Audit and Research Centre Case Mix Programme database.

    Science.gov (United States)

    Carle, C; Alexander, P; Columb, M; Johal, J

    2013-04-01

    We designed and internally validated an aggregate weighted early warning scoring system specific to the obstetric population that has the potential for use in the ward environment. Direct obstetric admissions from the Intensive Care National Audit and Research Centre's Case Mix Programme Database were randomly allocated to model development (n = 2240) or validation (n = 2200) sets. Physiological variables collected during the first 24 h of critical care admission were analysed. Logistic regression analysis for mortality in the model development set was initially used to create a statistically based early warning score. The statistical score was then modified to create a clinically acceptable early warning score. Important features of this clinical obstetric early warning score are that the variables are weighted according to their statistical importance, a surrogate for the FI O2 /Pa O2 relationship is included, conscious level is assessed using a simplified alert/not alert variable, and the score, trigger thresholds and response are consistent with the new non-obstetric National Early Warning Score system. The statistical and clinical early warning scores were internally validated using the validation set. The area under the receiver operating characteristic curve was 0.995 (95% CI 0.992-0.998) for the statistical score and 0.957 (95% CI 0.923-0.991) for the clinical score. Pre-existing empirically designed early warning scores were also validated in the same way for comparison. The area under the receiver operating characteristic curve was 0.955 (95% CI 0.922-0.988) for Swanton et al.'s Modified Early Obstetric Warning System, 0.937 (95% CI 0.884-0.991) for the obstetric early warning score suggested in the 2003-2005 Report on Confidential Enquiries into Maternal Deaths in the UK, and 0.973 (95% CI 0.957-0.989) for the non-obstetric National Early Warning Score. This highlights that the new clinical obstetric early warning score has an excellent ability to

  19. Perfil de la casuística hospitalaria de la población inmigrante en Barcelona Profile of the hospital case mix of the immigrant population in Barcelona, Spain

    Directory of Open Access Journals (Sweden)

    F. Cots

    2002-10-01

    la envejecida estructura de edad de los pacientes autóctonos y plantea la necesidad de recuperar el mayor peso de los servicios de ginecología-obstetricia y pediatría. El hecho de que exista menor consumo de recursos por alta hospitalaria en la población inmigrante de países de renta baja contradice la relación esperada de inmigrante-peor situación socioeconómica-mayor intensidad de consumo de recursos por alta hospitalaria. Deben proponerse nuevas hipótesis de trabajo y análisis que permitan explicar esta realidad.Objective: Although the immigrant population in cities such as Barcelona has tripled in the last five years, until now the impact of this group on the health system has not been rigorously evaluated. The aim of this study was to compare hospital resource utilization among the immigrant population with that among the native population through case mix, demographic characteristics and hospital day use. Material and methods: We analyzed 15,057 discharges from Hospital del Mar in Barcelona in 2000. This hospital attends 60% of admissions from the Ciutat Vella district. In 2000, 21% of the population of this district were immigrants. Socio-demographic patient characteristics and case mix were compared between the immigrant and the native population. Hospital resource use was compared according to age, case mix (diagnosis related groups and seriousness (severity, complications and comorbidities of the events requiring medical care. Results: The case mix of the immigrant population differed from that of the autochthonous population due to pronounced ge differences and a higher fertility rate. Thirty-three percent of immigrant admissions were for deliveries. The mean cost of discharge of immigrants from low-income countries was 30% lower than that for the remaining discharges. After adjusting for age, case mix and severity, length of stay among the immigrant population was significantly shorter. A 5% reduction was found after adjusting for case mix and a

  20. Comparing the case mix and survival of women receiving breast cancer care from one private provider with other London women with breast cancer: pilot data exchange and analyses.

    Science.gov (United States)

    Davies, Elizabeth A; Coupland, Victoria H; Dixon, Steve; Mokbel, Kefah; Jack, Ruth H

    2016-07-07

    Data from providers of private cancer care are not yet formally included in English cancer registration data. This study aimed to test the exchange of breast cancer data from one Hospital Corporation of America International (HCAI) hospital in London with the cancer registration system and assess the suitability of these data for comparative analyses of case mix and adjusted survival. Data on 199 London women receiving 'only HCAI care', 278 women receiving 'some HCAI care' (HCAI and other services), and 31,234 other London women diagnosed between 2005 and 2011 could be identified and compared. Overall survival was estimated using the Kaplan-Meier method, and Cox regression was used to adjust for age, socioeconomic deprivation, year of diagnosis, stage of disease and recorded treatment. Women receiving 'only HCAI care' were younger, lived in areas of higher affluence (47.8 % vs 27.6 %) and appeared less likely to be recorded as having screen-detected (2.5 % vs 25.0 %) disease than other London women. Women receiving 'some HCAI care' were more similar to 'HCAI only' women. Although HCAI stage of disease data completeness improved during the study period, this was less complete overall than cancer registration data and limited the comparative survival analyses. An apparent survival advantage for 'HCAI only' women compared with other London women (hazard ratio 0.48, 95 % confidence interval (CI): 0.32-0.74) was attenuated and no longer statistically significant after adjustment (0.79, 95 % CI: 0.51-1.21). Women receiving 'some HCAI care' appeared to have higher survival (hazard ratio 0.24, 95 % CI 0.14-0.41) which was attenuated to 0.48 (95 % CI: 0.28-0.80) in the fully adjusted model. Exchange of data between the private cancer sector and the English cancer registration service can identify patients who receive all or some private care. The better survival of women receiving only or some HCAI breast cancer care appears to be at least partly explained by

  1. Cultural Competence Among Italian Nurses: A Multicentric Survey.

    Science.gov (United States)

    Cicolini, Giancarlo; Della Pelle, Carlo; Comparcini, Dania; Tomietto, Marco; Cerratti, Francesca; Schim, Stephanie M; Di Giovanni, Pamela; Simonetti, Valentina

    2015-11-01

    To assess Italian nurses' cultural competence, as they are increasingly called upon to care for people of foreign origins. A cross-sectional, multicentric study. From September 2013 to May 2014, a survey was carried out among Italian nurses. Cultural competence was assessed by the Cultural Competence Assessment tool, translated and adapted to the Italian context. Nurses who completed the survey numbered 1,432; 70.6% were female; 42.6% ranged in age from 41 to 50 years; and 50.0% were bachelor's prepared. More than 50% had participated in some kind of cultural diversity training. Overall, cultural competence was moderate, showing a moderately high level of cultural awareness and sensitivity (mean = 5.41; SD = 0.66) and a moderate level of culturally competent behaviors (mean = 4.33; SD = 1.10). Although Italian nurses' cultural competence was acceptable, given the growing diversity of the patient population, nurses should be better prepared to face the changing health requests. Providing culturally competent care has been associated with improved provider-client communication, higher satisfaction with care, and health status improvement, as full comprehension of health status, adherence to medications and lifestyle recommendations, and appropriate utilization of the health system. Healthcare providers need to be adequately trained to provide culturally competent care. This research provides, for the first time, a report on Italian nurses' levels of cultural competence, and strengthens the current literature underlining the need for continuous education to enhance cultural competence among nurses. © 2015 Sigma Theta Tau International.

  2. Multicentric Giant Cell Tumor of Bone: Synchronous and Metachronous Presentation

    Directory of Open Access Journals (Sweden)

    Reiner Wirbel

    2013-01-01

    Full Text Available A 27-year-old man treated 2.5 years ago for synchronous multicentric giant cell tumor of bone located at the right proximal humerus and the right 5th finger presented now with complaints of pain in his right hip and wrist of two-month duration. Radiology and magnetic resonance revealed multicentric giant cell tumor lesions of the right proximal femur, the left ileum, the right distal radius, and the left distal tibia. The patient has an eighteen-year history of a healed osteosarcoma of the right tibia that was treated with chemotherapy, resection, and allograft reconstruction. A literature review establishes this as the first reported case of a patient with synchronous and metachronous multicentric giant cell tumor who also has a history of osteosarcoma.

  3. Ethical issues: the multi-centre low-risk ethics/governance review process and AMOSS.

    Science.gov (United States)

    Vaughan, Geraldine; Pollock, Wendy; Peek, Michael J; Knight, Marian; Ellwood, David; Homer, Caroline S; Pulver, Lisa Jackson; McLintock, Claire; Ho, Maria T; Sullivan, Elizabeth A

    2012-04-01

    The Australasian Maternity Outcomes Surveillance System (AMOSS) conducts surveillance and research of rare and serious conditions in pregnancy. This multi-centre population health study is considered low risk with minimal ethical impact. To describe the ethics/governance review pathway undertaken by AMOSS. Prospective, descriptive study during 2009-2011 of the governance/ethical review processes required to gain approval for Australian and New Zealand (ANZ) maternity units with more than 50 births per year (n = 303) to participate in AMOSS. Review processes ranged from a single application for 24 NZ sites, a single application for eligible hospitals in two Australian states, full Health Research Ethics Committee (HREC) applications for individual hospitals, through simple letters of support. As of September 2011, 46 full/expedited ethics applications, 131 site governance applications and 136 letters of support requests were made over 33 months, involving an estimated 3261 hours by AMOSS staff/investigators, and an associated resource burden by participating sites, to obtain approval to receive nonidentifiable data from 291 hospitals. The AMOSS research system provides an important resource to enhance knowledge of conditions that cause rare and serious maternal morbidity. Yet the highly variable ethical approval processes required to implement this study have been excessively repetitive and burdensome. This process jeopardises timely, efficient research project implementation, without corresponding benefits to research participants. The resource burden to establish research governance for AMOSS confirms the urgent need for the Harmonisation of Multi-centre Ethical Review (HoMER) to further streamline ethics/governance review processes for multi-centre research. © 2011 The Authors. Australian and New Zealand Journal of Obstetrics and Gynaecology © 2011 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  4. Multiple myeloma in Nigeria: a multi-centre epidemiological and ...

    African Journals Online (AJOL)

    Multiple myeloma in Nigeria: a multi-centre epidemiological and biomedical study. Nkiruka Nnonyelum Odunukwe, Jude Anazoeze Madu, Obigeli Eunice Nnodu, Titilola Stella Akingbola, Inyama Marcus Asuquo, Modupe Taiwo Balogun, Olufunto Olufela Kalejaiye, John Chinawaeze Aneke, Joseph Aondowase Orkuma, ...

  5. A Mobitz type II atrioventricular block in multicentric ischemic stroke ...

    African Journals Online (AJOL)

    Cardiac and cerebrovascular illnesses are major causes of mortality and morbidity. Thromboembolisms, which are the result of cardiac arrhythmia, are important causes of ischemic stroke. In this study, we present a rare case of multicentric ischemic stroke induced by Mobitz type II atrioventricular block. The Pan African ...

  6. A multicentre evaluation of emergency abdominal surgery in South ...

    African Journals Online (AJOL)

    Background. GlobalSurg-1 was a multicentre, international, prospective cohort study conducted to address the global lack of surgical outcomes data. Six South African (SA) hospitals participated in the landmark surgical outcomes study. In this subsequent study, we collated the data from these six local participants and ...

  7. Authorship issues in multi-centre clinical trials

    DEFF Research Database (Denmark)

    Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian

    2015-01-01

    Discussions about authorship often arise in multi-centre clinical trials. Such trials may involve up to hundreds of contributors of whom some will eventually co-author the final publication. It is, however, often impossible to involve all contributors in the manuscript process sufficiently for th...... to the original source....

  8. Authorship issues in multi-centre clinical trials

    DEFF Research Database (Denmark)

    Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian

    2015-01-01

    to qualify for authorship as defined by the International Committee of Medical Journal Editors. Therefore, rules for authorship in multi-centre trials are strongly recommended. We propose two contracts to prevent conflicts regarding authorship; both are freely available for use without pay but with reference...... to the original source....

  9. Authorship issues in multi-centre clinical trials

    DEFF Research Database (Denmark)

    Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian

    2015-01-01

    to qualify for authorship as defined by the International Committee of Medical Journal Editors. Therefore, rules for authorship in multi-centre trials are strongly recommended. We propose two contracts to prevent conflicts regarding authorship; both are freely available for use without pay but with reference...

  10. Multicentre observational study of the Gatekeeper for faecal incontinence.

    Science.gov (United States)

    Ratto, C; Buntzen, S; Aigner, F; Altomare, D F; Heydari, A; Donisi, L; Lundby, L; Parello, A

    2016-02-01

    A variety of therapeutic approaches are available for faecal incontinence. Implantation of Gatekeeper prostheses is a new promising option. The primary endpoint of this prospective observational multicentre study was to assess the clinical efficacy of Gatekeeper implantation in patients with faecal incontinence. Secondary endpoints included the assessment of patients' quality of life, and the feasibility and safety of implantation. Patients with faecal incontinence, with either intact sphincters or internal anal sphincter lesions extending for less than 60° of the anal circumference, were selected. Intersphincteric implantation of six prostheses was performed. At baseline, and 1, 3 and 12 months after implantation, the number of faecal incontinence episodes, Cleveland Clinic Faecal Incontinence, Vaizey and American Medical Systems, Faecal Incontinence Quality of Life Scale and Short Form 36 Health Survey scores were recorded. Endoanal ultrasonography was performed at baseline and follow-up. Fifty-four patients were implanted. After Gatekeeper implantation, incontinence to gas, liquid and solid stool improved significantly, soiling was reduced, and ability to defer defaecation enhanced. All faecal incontinence severity scores were significantly reduced, and patients' quality of life improved. At 12 months, 30 patients (56 per cent) showed at least 75 per cent improvement in all faecal incontinence parameters, and seven (13 per cent) became fully continent. In three patients a single prosthesis was extruded during surgery, but was replaced immediately. After implantation, prosthesis dislodgement occurred in three patients; no replacement was required. Anal implantation of the Gatekeeper in patients with faecal incontinence was effective and safe. Clinical benefits were sustained at 1-year follow-up. © 2015 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.

  11. Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective.

    Science.gov (United States)

    Ezzat, Hanna; Ross, Sue; von Dadelszen, Peter; Morris, Tara; Liston, Robert; Magee, Laura A

    2010-07-30

    For ethical approval of a multicentre study in Canada, investigators must apply separately to individual Research Ethics Boards (REBs). In principle, the protection of human research subjects is of utmost importance. However, in practice, the process of multicentre ethics review can be time consuming and costly, requiring duplication of effort for researchers and REBs. We used our experience with ethical review of The Canadian Perinatal Network (CPN), to gain insight into the Canadian system. The applications forms of 16 different REBs were abstracted for a list of standardized items. The application process across sites was compared. Correspondence between the REB and the investigators was documented in order to construct a timeline to approval, identify the specific issues raised by each board, and describe how they were resolved. Each REB had a different application form. Most (n = 9) had a two or three step application process. Overall, it took a median of 31 days (range 2-174 days) to receive an initial response from the REB. Approval took a median of 42 days (range 4-443 days). Privacy and consent were the two major issues raised. Several additional minor or administrative issues were raised which delayed approval. For CPN, the Canadian REB process of ethical review proved challenging. REBs acted independently and without unified application forms or submission procedures. We call for a critical examination of the ethical, privacy and institutional review processes in Canada, to determine the best way to undertake multicentre review.

  12. Safety and performance of the next generation EnligHTN™ renal denervation system in patients with drug-resistant, uncontrolled hypertension: The EnligHTN III first-in-human multicentre study

    Directory of Open Access Journals (Sweden)

    Stephen G. Worthley

    2015-08-01

    Conclusions: Renal sympathetic denervation using the next generation EnligHTN renal denervation system resulted in safe, rapid, and significant mean office blood pressure reduction that was sustained through 6 months. Future studies will need to address the utility of this system against an appropriate placebo based comparator.

  13. A multicentre ‘end to end’ dosimetry audit for cervix HDR brachytherapy treatment

    International Nuclear Information System (INIS)

    Palmer, Antony L.; Diez, Patricia; Gandon, Laura; Wynn-Jones, Andrea; Bownes, Peter; Lee, Chris; Aird, Edwin; Bidmead, Margaret; Lowe, Gerry; Bradley, David; Nisbet, Andrew

    2015-01-01

    Purpose: To undertake the first multicentre fully ‘end to end’ dosimetry audit for HDR cervix brachytherapy, comparing planned and delivered dose distributions around clinical treatment applicators, with review of local procedures. Materials and methods: A film-dosimetry audit was performed at 46 centres, including imaging, applicator reconstruction, treatment planning and delivery. Film dose maps were calculated using triple-channel dosimetry and compared to RTDose data from treatment planning systems. Deviations between plan and measurement were quantified at prescription Point A and using gamma analysis. Local procedures were also discussed. Results: The mean difference between planned and measured dose at Point A was −0.6% for plastic applicators and −3.0% for metal applicators, at standard uncertainty 3.0% (k = 1). Isodose distributions agreed within 1 mm over a dose range 2–16 Gy. Mean gamma passing rates exceeded 97% for plastic and metal applicators at 3% (local) 2 mm criteria. Two errors were found: one dose normalisation error and one applicator library misaligned with the imaged applicator. Suggestions for quality improvement were also made. Conclusions: The concept of ‘end to end’ dosimetry audit for HDR brachytherapy has been successfully implemented in a multicentre environment, providing evidence that a high level of accuracy in brachytherapy dosimetry can be achieved

  14. Substantial shifts in ranking of California hospitals by hospital-associated methicillin-resistant Staphylococcus aureus infection following adjustment for hospital characteristics and case mix.

    Science.gov (United States)

    Tehrani, David M; Phelan, Michael J; Cao, Chenghua; Billimek, John; Datta, Rupak; Nguyen, Hoanglong; Kwark, Homin; Huang, Susan S

    2014-10-01

    States have established public reporting of hospital-associated (HA) infections-including those of methicillin-resistant Staphylococcus aureus (MRSA)-but do not account for hospital case mix or postdischarge events. Identify facility-level characteristics associated with HA-MRSA infection admissions and create adjusted hospital rankings. A retrospective cohort study of 2009-2010 California acute care hospitals. We defined HA-MRSA admissions as involving MRSA pneumonia or septicemia events arising during hospitalization or within 30 days after discharge. We used mandatory hospitalization and US Census data sets to generate hospital population characteristics by summarizing across admissions. Facility-level factors associated with hospitals' proportions of HA-MRSA infection admissions were identified using generalized linear models. Using state methodology, hospitals were categorized into 3 tiers of HA-MRSA infection prevention performance, using raw and adjusted values. Among 323 hospitals, a median of 16 HA-MRSA infections (range, 0-102) per 10,000 admissions was found. Hospitals serving a greater proportion of patients who had serious comorbidities, were from low-education zip codes, and were discharged to locations other than home were associated with higher HA-MRSA infection risk. Total concordance between all raw and adjusted hospital rankings was 0.45 (95% confidence interval, 0.40-0.51). Among 53 community hospitals in the poor-performance category, more than 20% moved into the average-performance category after adjustment. Similarly, among 71 hospitals in the superior-performance category, half moved into the average-performance category after adjustment. When adjusting for nonmodifiable facility characteristics and case mix, hospital rankings based on HA-MRSA infections substantially changed. Quality indicators for hospitals require adequate adjustment for patient population characteristics for valid interhospital performance comparisons.

  15. Protocol for the mWellcare trial: a multicentre, cluster randomised, 12-month, controlled trial to compare the effectiveness of mWellcare, an mHealth system for an integrated management of patients with hypertension and diabetes, versus enhanced usual care in India.

    Science.gov (United States)

    Jha, Dilip; Gupta, Priti; Ajay, Vamadevan S; Jindal, Devraj; Perel, Pablo; Prieto-Merino, David; Jacob, Pramod; Nyong, Jonathan; Venugopal, Vidya; Singh, Kavita; Goenka, Shifalika; Roy, Ambuj; Tandon, Nikhil; Patel, Vikram; Prabhakaran, Dorairaj

    2017-08-11

    Rising burden of cardiovascular disease (CVD) and diabetes is a major challenge to the health system in India. Innovative approaches such as mobile phone technology (mHealth) for electronic decision support in delivering evidence-based and integrated care for hypertension, diabetes and comorbid depression have potential to transform the primary healthcare system. METHODS AND ANALYSIS: mWellcare trial is a multicentre, cluster randomised controlled trial evaluating the clinical and cost-effectiveness of a mHealth system and nurse managed care for people with hypertension and diabetes in rural India. mWellcare system is an Android-based mobile application designed to generate algorithm-based clinical management prompts for treating hypertension and diabetes and also capable of storing health records, sending alerts and reminders for follow-up and adherence to medication. We recruited a total of 3702 participants from 40 Community Health Centres (CHCs), with ≥90 at each of the CHCs in the intervention and control (enhanced care) arms. The primary outcome is the difference in mean change (from baseline to 1 year) in systolic blood pressure and glycated haemoglobin (HbA1c) between the two treatment arms. The secondary outcomes are difference in mean change from baseline to 1 year in fasting plasma glucose, total cholesterol, predicted 10-year risk of CVD, depression, smoking behaviour, body mass index and alcohol use between the two treatment arms and cost-effectiveness. The study has been approved by the institutional Ethics Committees at Public Health Foundation of India and the London School of Hygiene and Tropical Medicine. Findings will be disseminated widely through peer-reviewed publications, conference presentations and other mechanisms. mWellcare trial is registered with Clinicaltrial.gov (Registration number NCT02480062; Pre-results) and Clinical Trial Registry of India (Registration number CTRI/2016/02/006641). The current version of the protocol is

  16. A developmental hypothesis to explain the multicentricity of breast cancer

    OpenAIRE

    Sharpe, C R

    1998-01-01

    In this article the author proposes that the multicentricity of breast cancer might be explained by a developmental hypothesis. Genetic alterations ("hits") occurring in epithelial stem cells during the development of the breast may be transmitted to populations of daughter cells during growth. As a result, areas of the breast may be predisposed to malignant transformation with the occurrence of further genetic hits. Areas with the same predisposition should be anatomically connected, and ear...

  17. Iohexol in investigations of the spinal canal. Multicentre study

    International Nuclear Information System (INIS)

    Bories, J.

    1988-01-01

    The author presents the results of a multicentric study of Iohexol in investigation of the spinal canal undertaken at the request of Winthrop Laboratories in 32 Radiological departments. The study involved 329 adults of both sexes. It confirmed the excellent quality of results obtained with this preparation in the literature and its excellent tolerance. On the basis of these results Iohexol may be considered to be definitely one of the best currently available preparations for investigation of the spinal canal [fr

  18. Are power calculations useful? A multicentre neuroimaging study

    OpenAIRE

    Suckling, John; Henty, Julian; Ecker, Christine; Deoni, Sean C; Lombardo, Michael V; Baron-Cohen, Simon; Jezzard, Peter; Barnes, Anna; Chakrabarti, Bhismadev; Ooi, Cinly; Lai, Meng-Chuan; Williams, Steven C; Murphy, Declan GM; Bullmore, Edward

    2014-01-01

    There are now many reports of imaging experiments with small cohorts of typical participants that precede large-scale, often multicentre studies of psychiatric and neurological disorders. Data from these calibration experiments are sufficient to make estimates of statistical power and predictions of sample size and minimum observable effect sizes. In this technical note, we suggest how previously reported voxel-based power calculations can support decision making in the design, execution and ...

  19. Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy in TYpe 2 diabetic patients with normoalbuminuria (PRIORITY) : Essential study design and rationale of a randomised clinical multicentre trial

    NARCIS (Netherlands)

    Lindhardt, Morten; Persson, Frederik; Currie, Gemma; Pontillo, Claudia; Beige, Joachim; Delles, Christian; von der Leyen, Heiko; Mischak, Harald; Navis, Gerjan; Noutsou, Marina; Ortiz, Alberto; Ruggenenti, Piero Luigi; Rychlik, Ivan; Spasovski, Goce; Rossing, Peter

    2016-01-01

    Introduction Diabetes mellitus affects 9% of the European population and accounts for 15% of healthcare expenditure, in particular, due to excess costs related to complications. Clinical trials aiming for earlier prevention of diabetic nephropathy by renin angiotensin system blocking treatment in

  20. Multicentric ameboma of the colon mimicking Crohn′s disease

    Directory of Open Access Journals (Sweden)

    Biggs Saravanan Ramachandran

    2015-01-01

    Full Text Available Entamoeba histolytica infection can lead to colitis, colonic perforation abscess, and ameboma formation. Amebic colitis is common in developing countries, with its varied and nonspecific symptoms. Amebomas can occur rarely due to the formation of excess granulation tissue which usually occurs in cecum and ascending colon. A 64-year-old lady presented with abdominal pain and mass in the right side of abdomen. Imaging showed multicentric colonic masses. On colonoscopy multiple stricturizing ulcerated lesions involving cecum, ascending, proximal transverse colon, and splenic flexure were seen, which were suggestive of Crohn′s disease or multicentric neoplasm. Histopathological examination revealed multicentric lesion with focal necrosis and trophozoites of E. histolytica. Diagnosis of ameboma was made and antiamoebic treatment was started. She had full resolution of symptoms. We present this case since it is a case of ameboma, a rare complication of amebic colitis with an extremely rare presentation of multiple ulcerated stricturizing lesions, involving cecum, ascending, transverse colon, and splenic flexure which typically resembled Crohn′s disease.

  1. Are power calculations useful? A multicentre neuroimaging study.

    Science.gov (United States)

    Suckling, John; Henty, Julian; Ecker, Christine; Deoni, Sean C; Lombardo, Michael V; Baron-Cohen, Simon; Jezzard, Peter; Barnes, Anna; Chakrabarti, Bhismadev; Ooi, Cinly; Lai, Meng-Chuan; Williams, Steven C; Murphy, Declan G M; Bullmore, Edward

    2014-08-01

    There are now many reports of imaging experiments with small cohorts of typical participants that precede large-scale, often multicentre studies of psychiatric and neurological disorders. Data from these calibration experiments are sufficient to make estimates of statistical power and predictions of sample size and minimum observable effect sizes. In this technical note, we suggest how previously reported voxel-based power calculations can support decision making in the design, execution and analysis of cross-sectional multicentre imaging studies. The choice of MRI acquisition sequence, distribution of recruitment across acquisition centres, and changes to the registration method applied during data analysis are considered as examples. The consequences of modification are explored in quantitative terms by assessing the impact on sample size for a fixed effect size and detectable effect size for a fixed sample size. The calibration experiment dataset used for illustration was a precursor to the now complete Medical Research Council Autism Imaging Multicentre Study (MRC-AIMS). Validation of the voxel-based power calculations is made by comparing the predicted values from the calibration experiment with those observed in MRC-AIMS. The effect of non-linear mappings during image registration to a standard stereotactic space on the prediction is explored with reference to the amount of local deformation. In summary, power calculations offer a validated, quantitative means of making informed choices on important factors that influence the outcome of studies that consume significant resources. Copyright © 2014 The Authors. Human Brain Mapping Published by Wiley Periodicals, Inc.

  2. Multicentre comparison Of shock efficacy using single-vs. Dual-coil lead systems and Anodal vs. cathodaL polarITY defibrillation in patients undergoing transvenous cardioverter-defibrillator implantation. The MODALITY study.

    Science.gov (United States)

    Baccillieri, Maria Stella; Gasparini, Gianni; Benacchio, Luca; Zorzi, Alessandro; Marras, Elena; Zerbo, Francesca; Tomasi, Luca; Vaccari, Diego; Pastore, Gianni; Bonanno, Carlo; Molon, Giulio; Zanotto, Gabriele; Fusco, Antonio; Carasi, Massimo; Zorzi, Andrea; Calzolari, Vittorio; Ignatiuk, Barbara; Cannas, Sergio; Vaglio, Alessandro; Al Bunni, Muhamad; Pedrini, Antonella; Olivieri, Armando; Rampazzo, Roberta; Minicuci, Nadia; Corrado, Domenico; Verlato, Roberto

    2015-06-01

    An optimal active-can lead configuration during implantable cardioverter defibrillator (ICD) placement is important to obtain an adequate defibrillation safety margin. The purpose of this multicenter study was to evaluate the rate of the first shock success at defibrillation testing according to the type of lead implant (single vs. dual coil) and shock polarity (cathodal and anodal) in a large series of consecutive patients who received transvenous ICDs. This was a multicenter study enrolling 469 consecutive patients. Single- versus dual-coil leads and cathodal versus anodal polarity were evaluated at defibrillation testing. In all cases, the value of the energy for the first shock was set to 20 J less than the maximum energy deliverable from the device. A total of 469 patients underwent defibrillation testing: 158 (34 %) had dual-coil and 311 (66 %) had single-coil lead systems configuration, 254 (54 %) received anodal shock and 215 (46 %) received cathodal shock. In 35 (7.4 %) patients, the shock was unsuccessful. No significant differences in the outcome of defibrillation testing using single- versus dual-coil lead were observed but the multivariate analysis showed an increased risk of shock failure using cathodal shock polarity (OR 2.37, 95 % CI 1.12-5.03). Both single- and dual-coil transvenous ICD lead systems were associated with high rates of successful ICD implantation, and we found no significant differences in ventricular arrhythmias interruption between the two ICD lead systems configuration. Instead, anodal defibrillation was more likely to be successful than cathodal defibrillation.

  3. 99mTc-DTPA aerosol for same-day post-perfusion ventilation imaging: Results of a multicentre study

    International Nuclear Information System (INIS)

    Koehn, H.; Koenig, B.; Bachmayr, S.; Markt, B.; Eber, O.; Lind, P.; Galvan, G.; Rettenbacher, L.; Holm, C.; Ogris, E.

    1993-01-01

    A multicentre study was performed in an attempt to evaluate a submicronic technetium-99m diethylene triamine penta-acetic acid aerosol generated by a newly developed delivery system, the aerosol production equipment (APE nebulizer), for same-day post-perfusion ventilation imaging in patients with clinically suspected pulmonary embolism. Quantitative comparison between the DTPA aerosol and krypton gas demonstrated a close correlation with respect to regional pulmonary distribution of activity and peripheral lung penetration (n=14, r=0.94, P 99m Tc-labelled DTPA aerosol is well suited for fast same-day post-perfusion ventilation imaging in patients with clinical suspicion of pulmonary embolism. (orig.)

  4. Multicentric Castleman’s Disease, Associated with Idiopathic Thrombocytopenic Purpura

    Directory of Open Access Journals (Sweden)

    Ruchi Sood

    2013-01-01

    Full Text Available The most common cause of a neck mass in young adults is hyperplastic lymphadenopathy consequent to infection and inflammation. Castleman’s disease (CD, an unusual benign lymphoproliferative disorder, infrequently causes neck masses. It occurs in unicentric (UCD and multicentric (MCD forms and is associated with human immunodeficiency virus (HIV, human herpes virus 8 (HHV-8, and Kaposi's sarcoma. We present the third known association between MCD and previous immune thrombocytopenia in the absence of HIV and HHV-8 infection and review its association with other autoimmune disorders and attendant implications for pathogenesis. Finally, we summarize the current approach to therapy.

  5. Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study

    OpenAIRE

    Noriega, David; Maestretti, Gianluca; Renaud, Christian; Francaviglia, Natale; Ould-Slimane, Mourad; Queinnec, Steffen; Ekkerlein, Helmut; Hassel, Frank; Gumpert, Rainer; Sabatier, Pascal; Huet, Herv?; Plasencia, Miguel; Theumann, Nicolas; Kunsky, Alexander; Kr?ger, Antonio

    2015-01-01

    This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 ho...

  6. Quality control and data-handling in multicentre studies: the case of the Multicentre Project for Tuberculosis Research

    Directory of Open Access Journals (Sweden)

    Caloto Teresa

    2001-12-01

    Full Text Available Abstract Background The Multicentre Project for Tuberculosis Research (MPTR was a clinical-epidemiological study on tuberculosis carried out in Spain from 1996 to 1998. In total, 96 centres scattered all over the country participated in the project, 19935 "possible cases" of tuberculosis were examined and 10053 finally included. Data-handling and quality control procedures implemented in the MPTR are described. Methods The study was divided in three phases: 1 preliminary phase, 2 field work 3 final phase. Quality control procedures during the three phases are described. Results: Preliminary phase: a organisation of the research team; b design of epidemiological tools; training of researchers. Field work: a data collection; b data computerisation; c data transmission; d data cleaning; e quality control audits; f confidentiality. Final phase: a final data cleaning; b final analysis. Conclusion The undertaking of a multicentre project implies the need to work with a heterogeneous research team and yet at the same time attain a common goal by following a homogeneous methodology. This demands an additional effort on quality control.

  7. Perinatal complications in patients with unisutural craniosynostosis: An international multicentre retrospective cohort study

    NARCIS (Netherlands)

    Cornelissen, Martijn J.; Softeland, Madiha; Apon, Inge; Ladfors, Lars; Mathijssen, Irene M. J.; Cohen-Overbeek, Titia E.; Bonsel, Gouke J.; Kolby, Lars

    2017-01-01

    Purpose Craniosynostosis may lead to hampered fetal head molding and birth complications. To study the interaction between single suture craniosynostosis and delivery complications, an international, multicentre, retrospective cohort study was performed. Materials and methods All infants born

  8. Multicentric Castleman's disease and Kaposi's sarcoma in a cyclosporin treated, HIV-1 negative patient: case report

    NARCIS (Netherlands)

    Bollen, J. M.; Polstra, A. M.; van der Kuyl, A. C.; Weel, J. F.; Noorduyn, L. A.; van Oers, M. H. J.; Cornelissen, M.

    2003-01-01

    BACKGROUND: Multicentric Castleman's disease (MCD) is a rare disease, but is more frequent in AIDS patients. MCD has only been reported twice before in patients receiving immunosuppressive therapy after renal transplantation, and never in patients receiving immunosuppressive therapy without

  9. Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, L.M.; Bloemenkamp, K.W.; Franssen, M.T.; Papatsonis, D.N.; Hajenius, P.J.; Hollmann, M.W.; Woiski, M.D.; Porath, M.; Berg, H.J. van den; Beek, E. van; Borchert, O.W.; Schuitemaker, N.; Sikkema, J.M.; Kuipers, A.H.; Logtenberg, S.L.; Salm, P.C. van der; Oude Rengerink, K.; Lopriore, E.; Akker-van Marle, M.E. van den; Cessie, S. le; Lith, J.M. van; Struys, M.M.; Mol, B.W.; Dahan, A; Middeldorp, J.M.

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an

  10. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M; Bloemenkamp, Kitty W; Franssen, Maureen T; Papatsonis, Dimitri N; Hajenius, Petra J; Hollmann, Markus W; Woiski, Mallory D; Porath, Martina; van den Berg, Hans J; van Beek, Erik; Borchert, Odette W H M; Schuitemaker, Nico; Sikkema, J Marko; Kuipers, A H M; Logtenberg, Sabine L M; van der Salm, Paulien C M; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M Elske; le Cessie, Saskia; van Lith, Jan M; Struys, Michel M; Mol, Ben Willem J; Dahan, Albert; Middeldorp, Johanna M; Oude Rengerink, K

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an

  11. Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M.; Bloemenkamp, Kitty W.; Franssen, Maureen T.; Papatsonis, Dimitri N.; Hajenius, Petra J.; Hollmann, Markus W.; Woiski, Mallory D.; Porath, Martina; van den Berg, Hans J.; van Beek, Erik; Borchert, Odette W. H. M.; Schuitemaker, Nico; Sikkema, J. Marko; Kuipers, A. H. M.; Logtenberg, Sabine L. M.; van der Salm, Paulien C. M.; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M. Elske; le Cessie, Saskia; van Lith, Jan M.; Struys, Michel M.; Mol, Ben Willem J.; Dahan, Albert; Middeldorp, Johanna M.

    2015-01-01

    To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Multicentre randomised controlled equivalence trial. 15 hospitals in the Netherlands. Women with an intermediate to high obstetric risk with an

  12. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M.; Bloemenkamp, Kitty W.; Franssen, Maureen T.; Papatsonis, Dimitri N.; Hajenius, Petra J.; Hollmann, Markus W.; Woiski, Mallory D.; Porath, Martina; van den Berg, Hans J.; van Beek, Erik; Borchert, Odette W. H. M.; Schuitemaker, Nico; Sikkema, J. Marko; Kuipers, A. H. M.; Logtenberg, Sabine L. M.; van der Salm, Paulien C. M.; Rengerink, Katrien Oude; Lopriore, Enrico; van den Akker-van Marle, M. Elske; le Cessie, Saskia; van Lith, Jan M.; Struys, Michel M.; Mol, Ben Willem J.; Dahan, Albert; Middeldorp, Johanna M.

    2015-01-01

    Objective To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Design Multicentre randomised controlled equivalence trial. Setting 15 hospitals in the Netherlands. Participants Women with an

  13. Multicentric Biatrial Myxoma in a Young Female Patient: Case Report

    Science.gov (United States)

    Yoon, Sang Jeong; Park, Soon Chang; You, Yun Pyo; Kim, Bum Yong; Kim, Myong Kon; Jeong, Kyung Tae; Lee, Jae Won

    2000-01-01

    We report a case of multicentric, biatrial cardiac myxoma in a 29-year-old female who complained of exertional dyspnea, abdominal distension and peripheral edema. Any other associated skin lesions, breast mass or endocrine disorder presenting complex form were not seen on her. Also, there was no contributory medical history, hypertension and diabetes mellitus. By using transthoracic echocardiography, we identified a biatrial myxoma attached to the interatrial septum. During surgical excision, we found a large right atrial myxoma with extension through the fossa ovalis into the left atrium and small myxoma attached to the right atrial free wall. After successful resection of interatrial septum and free wall, atrial septal defect was created during the resection and safely repaired by bovine pericardial patch. PMID:11242813

  14. Multicentric Castleman's disease in a child with subpectoral involvement

    Energy Technology Data Exchange (ETDEWEB)

    Kosucu, Polat; Ahmetoglu, Ali; Guemele, Halit Resit [Department of Radiology, Farabi Hospital, Medical School of Karadeniz Technical University, 61080 Trabzon (Turkey); Imamoglu, Mustafa; Cay, Ali [Department of Pediatric Surgery, Farabi Hospital, Medical School of Karadeniz Technical University, Trabzon (Turkey); Cobanoglu, Uemit [Department of Pathology, Farabi Hospital, Medical School of Karadeniz Technical University, Trabzon (Turkey)

    2003-08-01

    Castleman's disease is a benign lymphoproliferative disorder characterised by enlarged hyperplastic lymph nodes. It is rare in children and usually presents as localised disease. Subpectoral involvement has not been previously described in multicentric Castleman's disease in children. We present the CT, US and Doppler US findings of hyaline-vascular type multicentric Castleman's disease in a 5 year-old-boy with masses in the left subpectoral region and supraclavicular and axillary lymphadenopathy. (orig.)

  15. Multicentre performance evaluation of the E170 module for modular analytics.

    Science.gov (United States)

    Bieglmayer, Christian; Chan, Daniel W; Sokoll, Lori; Imdahl, Roland; Kobayashi, Masaji; Yamada, Erike; Lilje, Diana J; Luthe, Hilmar; Meissner, Jochen; Messeri, Gianni; Celli, Alessandra; Tozzi, Paola; Roth, Heinz-Jürgen; Schmidt, Frank-Peter; Mächler, Marie-Luise; Schuff-Werner, Peter; Zingler, Christiana; Smitz, Johan; Schiettecatte, Johan; Vonderschmitt, Dieter J; Pei, Patrick; Ng, Katherine; Ebert, Christoph; Kirch, Peter; Wanger, Michael; McGovern, Margaret; Stockmann, Wolfgang; Kuns, Albert

    2004-01-01

    The E170 module was evaluated at 13 sites in an international multicentre study. The objective of the study was to assess the analytical performance of 49 analytes, and to collect feedback on the system's reliability and practicability. The typical, within-run coefficients of variation (CVs) for most of the quantitative assays ranged between 1 and 2% while a range of 2-4% was achieved with the infectious disease methods. Total precision CVs were found to be within the manufacturer's expected performance ranges, demonstrating good concordance of the system's measuring channels and a high reproducibility during the 2-4-week trial period. The functional sensitivity of 11 selected assays met the clinical requirements (e.g., thyreotroponin (TSH) 0.008 mU/l, troponin T 0.02 microg/l, total prostate-specific antigen (PSA) 0.03 microg/l). The E170 showed no drift during an 8-hour period and no relevant reagent carryover. Accuracy was confirmed by ring trial experiments and method comparisons vs. Elecsys 2010. The reliability and practicability of the system's hardware and software met with, or even exceeded, the evaluator's requirements. Workflow studies showed that E170 can cover the combined workload of various routine analysers in a variety of laboratory environment. Throughput and sample processing time requirements were achieved while personnel 'hands-on-time' could be reduced.

  16. Multicentre prospective evaluation of implant-assisted mandibular removable partial dentures: surgical and prosthodontic outcomes.

    Science.gov (United States)

    Payne, Alan G T; Tawse-Smith, Andrew; Wismeijer, Daniel; De Silva, Rohana K; Ma, Sunyoung

    2017-01-01

    To determine implant survival and prosthodontic maintenance of implant-assisted mandibular removable partial dentures in a multicentre prospective study up to 10 years. Forty-eight participants with mandibular distal extension partial dentures were selected. A control group of 12 New Zealand participants had new conventional mandibular partial dentures made. Three test groups of 36 participants in New Zealand (n = 12), the Netherlands (n = 12) and Colombia (n = 12) had bilateral distal implants placed. Surgical and prosthodontic outcomes were documented with only healing caps placed (Stage 1) and with an attachment system (Stage 2). No implants failed after 3 years. Four late implant failures in three participants occurred in New Zealand (two unilateral implant failures after 5 and 8 years and two bilateral implant failures in the same participant after 6 and 10 years); two unilateral late implant failures occurred in the Netherlands and no late failures in Colombia. Implant survival rate was 92% by 10 years. Resonance frequency measurements were taken at surgery implant stability quotient (ISQ) 62.44 ± 7.46; range 40 - 79), baseline (ISQ 63.22 ± 6.17; range 50 - 74) and after 3 years (ISQ 66.38 ± 6.77; range 55 - 83). In New Zealand and Colombia, measured crestal bone levels were 2.03 ± 0.71 mm and 2.20 ± 0.81 mm, respectively, at baseline and 3 years. For Stage I, principal prosthodontic maintenance issues were loose healing caps among 10 New Zealand participants, four Colombian participants and one Netherlands participant. For Stage 2, matrix activation and overdenture puncture fractures resulted in 41 events (25 participants) in New Zealand over 10 years, whilst over 3 years, there were 14 events in nine Colombian participants and six events in five Netherlands participants. This clinical multicentre research complements previous case reports, case series, retrospective and prospective studies on the notion of implant

  17. Diagnostic and neural analysis of skin cancer (DANAOS). A multicentre study for collection and computer-aided analysis of data from pigmented skin lesions using digital dermoscopy.

    Science.gov (United States)

    Hoffmann, K; Gambichler, T; Rick, A; Kreutz, M; Anschuetz, M; Grünendick, T; Orlikov, A; Gehlen, S; Perotti, R; Andreassi, L; Newton Bishop, J; Césarini, J-P; Fischer, T; Frosch, P J; Lindskov, R; Mackie, R; Nashan, D; Sommer, A; Neumann, M; Ortonne, J P; Bahadoran, P; Penas, P F; Zoras, U; Altmeyer, P

    2003-10-01

    Early detection of melanomas by means of diverse screening campaigns is an important step towards a reduction in mortality. Computer-aided analysis of digital images obtained by dermoscopy has been reported to be an accurate, practical and time-saving tool for the evaluation of pigmented skin lesions (PSLs). A prototype for the computer-aided diagnosis of PSLs using artificial neural networks (NNs) has recently been developed: diagnostic and neural analysis of skin cancer (DANAOS). To demonstrate the accuracy of PSL diagnosis by the DANAOS expert system, a multicentre study on a diverse multinational population was conducted. A calibrated camera system was developed and used to collect images of PSLs in a multicentre study in 13 dermatology centres in nine European countries. The dataset was used to train an NN expert system for the computer-aided diagnosis of melanoma. We analysed different aspects of the data collection and its influence on the performance of the expert system. The NN expert system was trained with a dataset of 2218 dermoscopic images of PSLs. The resulting expert system showed a performance similar to that of dermatologists as published in the literature. The performance depended on the size and quality of the database and its selection. The need for a large database, the usefulness of multicentre data collection, as well as the benefit of a representative collection of cases from clinical practice, were demonstrated in this trial. Images that were difficult to classify using the NN expert system were not identical to those found difficult to classify by clinicians. We suggest therefore that the combination of clinician and computer may potentially increase the accuracy of PSL diagnosis. This may result in improved detection of melanoma and a reduction in unnecessary excisions.

  18. [Multicentric lymphoma in 411 dogs - an epidemiological study].

    Science.gov (United States)

    Ernst, Theresa; Kessler, Martin; Lautscham, Esther; Willimzig, Lisanne; Neiger, Reto

    2016-08-17

    To provide an overview of the epidemiology of canine multicentric lymphoma in Germany. A total of 411 dogs with multicentric malignant lymphoma were retrospectively analysed regarding breed, age, sex, weight and the number of animals dogs with hypercalcaemic lymphoma and B-/T-immunophenotype, and compared to two reference populations (total own clinic population, n   =   52  142; dogs with health insurance in Germany, n   =   123  423). In total, 298 (72.5%) of the 411 dogs belonged to 86 different breeds, while 113 (27.5%) dogs were mixed breed. In comparison to both reference populations, a breed predisposition for the American Pitbull Terrier (odds ratio [OR] 5.2 and 18.5), American Staffordshire Terrier (OR 3.3 and 4.6), Briard (OR 5.6 and 9.5), Bullmastiff (OR 7.8 and 5.0), Irish Setter (OR 3.3 and 4.1) and Rottweiler (OR 2.8 and 3.6) was found. Golden Retrievers (n = 22, OR 1.3 and 0.9) and Bernese Mountain Dogs (n = 22, OR 2.4 and 2.0) were frequently affected in absolute numbers, but when compared to the reference populations an OR < 3 was detected. Mean body weight was 30.2 ± 13.7 kg; only 75 (18%) dogs weighed < 15 kg. Amongst the small dogs (< 15 kg), there was a large number of West Highland White Terriers (n = 12). Mean age of the dogs with lymphoma was 7.9 ± 2.7 years. Dogs weighing ≥ 15 kg were significantly (p < 0.001) younger (7.6 ± 2.4 years) compared to dogs weighing < 15 kg (9.3 ± 3.2 years). Dogs with a B-cell immunophenotype (8.5 ± 2.6 years) were significantly older compared to dogs with a T-cell immunophenotype (6.4 ± 1.8 years) (p < 0.001). There was no gender predisposition (54% male, 46% female). Hypercalcaemia as an indicator of T-cell lymphoma was present in 44 (11.4%) of the dogs. A T-cell and B-cell immunophenotype was found in 20.6% and 79.4% of the dogs, respectively. This study confirms previous data about breed predispositions for canine malignant multicentric

  19. Multicentre dose audit for clinical trials of radiation therapy in Asia.

    Science.gov (United States)

    Mizuno, Hideyuki; Fukuda, Shigekazu; Fukumura, Akifumi; Nakamura, Yuzuru-Kutsutani; Jianping, Cao; Cho, Chul-Koo; Supriana, Nana; Dung, To Anh; Calaguas, Miriam Joy; Devi, C R Beena; Chansilpa, Yaowalak; Banu, Parvin Akhter; Riaz, Masooma; Esentayeva, Surya; Kato, Shingo; Karasawa, Kumiko; Tsujii, Hirohiko

    2017-05-01

    A dose audit of 16 facilities in 11 countries has been performed within the framework of the Forum for Nuclear Cooperation in Asia (FNCA) quality assurance program. The quality of radiation dosimetry varies because of the large variation in radiation therapy among the participating countries. One of the most important aspects of international multicentre clinical trials is uniformity of absolute dose between centres. The National Institute of Radiological Sciences (NIRS) in Japan has conducted a dose audit of participating countries since 2006 by using radiophotoluminescent glass dosimeters (RGDs). RGDs have been successfully applied to a domestic postal dose audit in Japan. The authors used the same audit system to perform a dose audit of the FNCA countries. The average and standard deviation of the relative deviation between the measured and intended dose among 46 beams was 0.4% and 1.5% (k = 1), respectively. This is an excellent level of uniformity for the multicountry data. However, of the 46 beams measured, a single beam exceeded the permitted tolerance level of ±5%. We investigated the cause for this and solved the problem. This event highlights the importance of external audits in radiation therapy. © The Author 2016. Published by Oxford University Press on behalf of The Japan Radiation Research Society and Japanese Society for Radiation Oncology.

  20. EANM/EARL harmonization strategies in PET quantification: from daily practice to multicentre oncological studies

    Energy Technology Data Exchange (ETDEWEB)

    Aide, Nicolas [University Hospital, Nuclear Medicine Department, Caen (France); Caen University, Inserm U1086 ANTICIPE, Caen (France); Lasnon, Charline [Caen University, Inserm U1086 ANTICIPE, Caen (France); Francois Baclesse Cancer Centre, Nuclear Medicine Department, Caen (France); Veit-Haibach, Patrick [University Hospital Zurich, Department of Nuclear Medicine and Department of Diagnostic and Interventional Radiology, Zurich (Switzerland); University Health Network, University of Toronto, Joint Department Medical Imaging, Toronto (Canada); Sera, Terez [University of Szeged, Nuclear Medicine Department, Szeged (Hungary); Sattler, Bernhard [University Hospital of Leipzig, Department of Nuclear Medicine, Leipzig (Germany); Boellaard, Ronald [University of Groningen, University Medical Center Groningen, Department of Nuclear Medicine and Molecular Imaging, Groningen (Netherlands); VU University Medical Center, Department of Radiology and Nuclear Medicine, Amsterdam (Netherlands)

    2017-08-15

    Quantitative positron emission tomography/computed tomography (PET/CT) can be used as diagnostic or prognostic tools (i.e. single measurement) or for therapy monitoring (i.e. longitudinal studies) in multicentre studies. Use of quantitative parameters, such as standardized uptake values (SUVs), metabolic active tumor volumes (MATVs) or total lesion glycolysis (TLG), in a multicenter setting requires that these parameters be comparable among patients and sites, regardless of the PET/CT system used. This review describes the motivations and the methodologies for quantitative PET/CT performance harmonization with emphasis on the EANM Research Ltd. (EARL) Fluorodeoxyglucose (FDG) PET/CT accreditation program, one of the international harmonization programs aiming at using FDG PET as a quantitative imaging biomarker. In addition, future accreditation initiatives will be discussed. The validation of the EARL accreditation program to harmonize SUVs and MATVs is described in a wide range of tumor types, with focus on therapy assessment using either the European Organization for Research and Treatment of Cancer (EORTC) criteria or PET Evaluation Response Criteria in Solid Tumors (PERCIST), as well as liver-based scales such as the Deauville score. Finally, also presented in this paper are the results from a survey across 51 EARL-accredited centers reporting how the program was implemented and its impact on daily routine and in clinical trials, harmonization of new metrics such as MATV and heterogeneity features. (orig.)

  1. Managing acute alcohol withdrawal with Homoeopathy: A prospective, observational, multicentre exploratory study

    Directory of Open Access Journals (Sweden)

    Debadatta Nayak

    2014-01-01

    Full Text Available Background: Alcohol dependence is a common social problem which may be associated with other risk factors and co-morbidities. Abrupt cessation of alcohol intake may provoke an acute alcohol withdrawal phase with varying degrees of signs and symptoms. In conventional medical system, specific pharmacological interventions are used for management of Acute Alcohol Withdrawal (AAW. There exists a need to explore safe and holistic treatment of AAW. The present work reports the results of a prospective, observational, exploratory, multicentre trial (2008-2011 to assess the role of Homoeopathy in AAW. Materials and Methods: Individualised Homoeopathy was given to 112 patients reporting with AAW. The clinical assessment was done for 05 days using Clinical Institute Withdrawal Assessment Scale of Alcohol-Revised (CIWA-Ar. Post-withdrawal phase, quality of life of patients was assessed at end of 01 st , 03 rd and 06 th month using World Health Organisation quality of life (WHOQOL- BREF. Results and Analysis: There was a significant decrease in CIWA-Ar mean scores and increase in quality of life score (P < 0.001. The most common remedies used were Arsenicum album, Lycopodium clavatum, Belladonna, Nux vomica and Pulsatilla. Conclusion: The results of current observational pilot study suggest the promising use of Homoeopathy in the management of acute alcohol withdrawal. Further studies with large sample size and rigorous design are warranted.

  2. Reduced prevalence of obesity in children with primary fructose malabsorption: a multicentre, retrospective cohort study.

    Science.gov (United States)

    Disse, S C; Buelow, A; Boedeker, R-H; Keller, K-M; Kim-Berger, H-S; Wudy, S A; Zimmer, K-P

    2013-08-01

    Studies in animals and in man have demonstrated that excessive consumption of fructose can cause all components of the metabolic syndrome. To investigate the impact of a condition resulting in decreased absorption of fructose, on obesity. In a multicentre study, we analyzed a cohort of paediatric patients with suspected primary fructose malabsorption (FM). Patients with chronic intestinal diseases were excluded. The final cohort comprised 628 patients. 302 patients were diagnosed with primary FM (48.1%). The proportion of obese patients was lower among FM patients, compared to non-FM patients (2.3 vs. 6.1%, P = 0.029). Logistic regression analysis with inclusion of various covariates showed that FM was negatively associated with obesity (OR 0.35, 95% CI [0.13; 0.97]). We discuss several mechanisms involving the metabolic, endocrine and gastrointestinal system. Our data indicate that primary FM is negatively associated with childhood obesity. © 2013 The Authors. Pediatric Obesity © 2013 International Association for the Study of Obesity.

  3. Wilson loops from multicentre and rotating branes, mass gaps and phase structure in gauge theories

    CERN Document Server

    Brandhuber, A.

    1999-01-01

    Within the AdS/CFT correspondence we use multicentre D3-brane metrics to investigate Wilson loops and compute the associated heavy quark-antiquark potentials for the strongly coupled SU(N) super-Yang-Mills gauge theory, when the gauge symmetry is broken by the expectation values of the scalar fields. For the case of a uniform distribution of D3-branes over a disc, we find that there exists a maximum separation beyond which there is no force between the quark and the antiquark, i.e. the screening is complete. We associate this phenomenon with the possible existence of a mass gap in the strongly coupled gauge theory. In the finite-temperature case, when the corresponding supergravity solution is a rotating D3-brane solution, there is a class of potentials interpolating between a Coulombic and a confining behaviour. However, above a certain critical value of the mass parameter, the potentials exhibit a behaviour characteristic of statistical systems undergoing phase transitions. The physical path preserves the c...

  4. Homoeopathic pathogenetic trial of Withania somnifera: A multicentric, double-blind, randomised, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Pritha Mehra

    2017-01-01

    Full Text Available Background: Homoeopathic drug proving being the first step in finding the pathogenetic powers of a drug is an integral part of Homoeopathic system of medicine. Objective: To elicit the pathogenetic response of Withania somnifera in homoeopathic potencies on healthy human provers. Materials and Methods: A multicentre, randomised, double-blind, placebo-controlled trial was conducted at four centres under Central Council for Research in Homoeopathy. Proving was conducted on 63 relatively healthy provers. All the provers were given 12 doses of placebo divided into 4 doses/day for 3 days during the first phase of the trial. After randomisation, 43 provers in the intervention group were given W. somnifera in 6C and 30C potencies in two phases. In the placebo group, 20 provers were administered unmedicated globules. The symptoms and signs manifested during the trial were noted down by the provers, elaborated by the proving masters and the data compilation on W. somnifera was done at proving-cum-data processing cell. Results: Out of 43 provers who were on actual drug trial, only 15 provers manifested 39 symptoms. The symptoms have been manifested predominantly in 30C potency. Among the objective findings, the drug has shown its effect on kidney, ovaries and helminthic infestation. Conclusion: The pathogenetic response elicited during this trial expands the scope of the use of W. somnifera and needs to be further validated by clinical verification study.

  5. Captopril radionuclide test in renovascular hypertension: a European multicentre study

    Energy Technology Data Exchange (ETDEWEB)

    Fommei, E. (Inst. of Clinical Physiology, C.N.R., Multicentre Study Central Office, Pisa (Italy)); Ghione, S. (Inst. of Clinical Physiology, C.N.R., Multicentre Study Central Office, Pisa (Italy)); Hilson, A.J.W. (Inst. of Clinical Physiology, C.N.R., Multicentre Study Central Office, Pisa (Italy)); Mezzasalma, L. (Inst. of Clinical Physiology, C.N.R., Multicentre Study Central Office, Pisa (Italy)); Oei, H.Y. (Inst. of Clinical Physiology, C.N.R., Multicentre Study Central Office, Pisa (Italy)); Piepsz, A. (Inst. of Clinical Physiology, C.N.R., Multicentre Study Central Office, Pisa (Italy)); Volterrani, D. (Inst. of Clinical Physiology, C.N.R., Multicentre Study Central Office, Pisa (Italy)); European Multicentre Study Group

    1993-07-01

    The efficacy of renal scintigraphy with technetium-99m DTPA before and after captopril was evaluated in a multicentre study. All 380 hypertensive patients in the study underwent renal arteriography; 125 had renal arterial stenosis [>=]70%, and 54 had a technically successful intervention to correct the stenosis. The post-captopril study had a sensitivity of 93% and a specificity of 100% for predicting blood pressure response to intervention, if renal function was normal and a combination of quantitative parameters was applied. In the entire population renal artery stenosis [>=]70% was detected with a sensitivity of 83% and a specificity of 93% if renal function was normal. In patients with abnormal renal function the performance of the test was worse, owing to a lower specificity which could be increased by using only time parameters. The performance of the test was optimal when the post-captopril findings were examined; no improvement was achieved by evaluation of the changes induced by captopril from the baseline. The test can thus be simplified by performing only a post-captopril study for routine use: a negative test would exclude a curable form of renovascular hypertension in right angle 80% and a positive test would predict it in right angle 90% of the patients selected for suspicion of the disease. Usefulness of the scintigraphic test for monitoring the clinical results of intervention is suggested by correlating post-intervention outcome with pre- and post-intervention scintigraphic results. (orig./MG)

  6. Multicentric lymphoma in a giant anteater (Myrmecophaga tridactyla).

    Science.gov (United States)

    Sanches, Adrien W D; Werner, Pedro R; Margarido, Tereza C C; Pachaly, Jose R

    2013-03-01

    Neoplastic disease is not well documented in giant anteaters. This report describes a disseminated lymphoma in an adult male giant anteater (Myrmecophaga tridactyla) from the City Zoo of Curitiba, State of Paraná, Brazil. No clinical signs were noticed before its death, except for a slight inappetence. At postmortem examination, pale white to yellow, variably sized nodules infiltrated the heart, liver, and intestinal lymph nodes. Histologically, two distinct cell populations were present in the nodular lesions: one characterized by smaller cells, primarily lymphocytic in nature, and another characterized by larger rounded cells with loose chromatin and frequently indented nuclei resembling histiocytes. Giant binucleated cells were occasionally observed. Mitotic figures numbered 2-3 mitotic figures/x400 field. Both cellular populations presented with moderate pleomorphism, large nuclei, a high nucleus-to-cytoplasm ratio, distinct nucleoli, and coarse nuclear chromatin. The neoplasia was classified as a form of multicentric lymphohistiocytic lymphoma (Rappaport Classification) and as an intermediate grade lymphoma (National Cancer Institute Working Formulation).

  7. Feline primary erythrocytosis: a multicentre case series of 18 cats.

    Science.gov (United States)

    Darcy, Hannah; Simpson, Katherine; Gajanayake, Isuru; Seth, Mayank; McGrotty, Yvonne; Szladovits, Balazs; Glanemann, Barbara

    2018-01-01

    Case series summary A retrospective multicentre case series of feline primary erythrocytosis (PE) was evaluated. The aim was to gain better understanding of disease presentation and progression to guide management and prognostication. Case records were assessed for evidence of increased packed cell volume (PCV; >48%), sufficient investigation to rule out relative and secondary erythrocytosis, and follow-up data for at least 12 months or until death. Eighteen cats were included in the case series. No significant trends in signalment were noted. Seizures and mentation changes were the most common presenting signs (both n = 10). Median PCV was 70% (median total protein concentration of 76 g/l) with no other consistent haematological changes. Sixteen cats survived to discharge. Phlebotomy was performed initially in 15/16 surviving animals and performed after discharge in 10/16. Hydroxyurea was the most common adjunctive therapy, used in 10/16 cats. Of the 16 patients surviving to discharge, 14 patients were still alive at the conclusion of the study (survival time >17 months post-discharge), with the two non-survivors having lived for 5 years or more after diagnosis. PCV, when stabilised, did not correlate with resolution of clinical signs. Relevance and novel information In contrast to perceptions, feline PE was generally well managed via a combination of phlebotomy and medical therapy, with evidence of prolonged survival times. The use of hydroxyurea enabled cessation or repeat phlebotomies.

  8. Multiple sclerosis in Belgian children: A multicentre retrospective study.

    Science.gov (United States)

    Verhelst, Helene; De Waele, Liesbeth; Deconinck, Nicolas; Ceulemans, Berten; Willekens, Barbara; Van Coster, Rudy

    2017-03-01

    Although the diagnosis of multiple sclerosis (MS) in the paediatric population remains challenging, paediatric-onset MS is increasingly recognized worldwide. We report on the clinical and biochemical features of a Belgian multicentre cohort of paediatric MS patients in a national retrospective descriptive study. Twenty one paediatric MS patients from four Belgian University Hospitals were included. In nine patients, onset of MS was before the age of ten years which makes the study cohort of special interest. We report a higher incidence of acute disseminated encephalomyelitis (ADEM)-like first MS attacks and an overall higher proportion of polysymptomatic episodes than in adult and most paediatric cohorts reported in the literature. The clinical presentation in our cohort was rather severe with high median EDSS-score during the first clinical manifestation and barely more than half of our study patients showing full recovery after their first clinical manifestation. Also, a significant proportion of children in our cohort has severe disease progression despite disease modifying therapy and 9.5% of patients showed transition to secondary progressive multiple sclerosis during adolescence. An early and correct diagnosis of paediatric MS is essential to start early adequate treatment. As illustrated by our study cohort, current treatment options in childhood are unsatisfactory. Copyright © 2016 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

  9. Recurrent pericarditis in children and adolescents: a multicentre cohort study.

    Science.gov (United States)

    Imazio, Massimo; Brucato, Antonio; Pluymaekers, Nikki; Breda, Luciana; Calabri, Giovanni; Cantarini, Luca; Cimaz, Rolando; Colimodio, Filomena; Corona, Fabrizia; Cumetti, Davide; Cuccio, Chiara Di Blasi Lo; Gattorno, Marco; Insalaco, Antonella; Limongelli, Giuseppe; Russo, Maria Giovanna; Valenti, Anna; Finkelstein, Yaron; Martini, Alberto

    2016-09-01

    Limited data are available about recurrent pericarditis in children. We sought to explore contemporary causes, characteristics, therapies and outcomes of recurrent pericarditis in paediatric patients. A multicentre (eight sites) cohort study of 110 consecutive cases of paediatric patients with at least two recurrences of pericarditis over an 11-year period (2000-2010) [median 13 years, interquartile range (IQR) 5, 69 boys]. Recurrences were idiopathic or viral in 89.1% of cases, followed by postpericardiotomy syndrome (9.1%) and familial Mediterranean fever (0.9%). Recurrent pericarditis was treated with nonsteroidal anti-inflammatory drugs (NSAIDs) in 80.9% of cases, corticosteroids in 64.8% and colchicine was added in 61.8%. Immunosuppressive therapies were administered in 15.5% of patients after subsequent recurrences. After a median follow-up of 60th months, 528 subsequent recurrences were recorded (median 3, range 2-25). Corticosteroid-treated patients experienced more recurrences (standardized risk of recurrence per 100 person-years was 93.2 for patients treated with corticosteroids and 45.2 for those without), side effects and disease-related hospitalizations (for all P pericarditis developed in 2.7% of patients. Recurrent pericarditis has an overall favourable prognosis in children, although it may require frequent readmissions and seriously affect the quality of life, especially in patients treated with corticosteroids. Colchicine or anakinra therapies were associated with significant decrease in the risk of recurrence.

  10. [Candidemias: multicentre analysis in 16 hospitals in Andalusia (Spain)].

    Science.gov (United States)

    Rodríguez-Hernández, M Jesús; Ruiz-Pérez de Pipaon, Maite; Márquez-Solero, Manuel; Martín-Rico, Patricia; Castón-Osorio, Juan José; Guerrero-Sánchez, Francisca M; Vidal-Verdú, Elisa; García-Figueras, Carolina; Del Arco-Jiménez, Alfonso; Rodríguez-Baño, Jesús; Martín-Mazuelos, Estrella; Cisneros-Herreros, José Miguel

    2011-05-01

    Candidemia is a nosocomial infection with high associated mortality. There have been changes in microbiology, epidemiology and treatment over the last few years, which has led us to analyse our own situation. Prospective, multicentre and observational study. All episodes of candidemia in adult patients seen in 17 Andalusian hospitals from 1 October 2005 to 30 September 2006 were included. Were detected 220 cases, the incidence was 0.58 cases/1,000 hospital discharges. Candida albicans was the most frecuent species (53% of cases). The majority of isolates (89%) was susceptibility to fluconazole. Sepsis was the most frequent clinical manifestation (65.7%). The treatment was inadequate in 38.7% of cases. Overall mortality was 40%. On univarite analysis death was found to be significantly associated with: aged > 60 years, unknown candidemia focus, Pitt score ≥ 2, APACHE II, shock at onset, persistents positive second blood cultures, non-removal of the central venous catheter and Candida species different of C. parasilopsis, among others. In the multivariate analysis death was found to be significantly associated with: aged > 60 years, Pitt score ≥ 2, Candida species different of C.parasilopsis and inadequate treatment. The candidemia clinical epidemiology in our region is similar to other areas and receiving inadequate treatment is the only modifiable risk factor associated with higher odds of mortality. Therefore, this modifiable factor needs to be improved to reduce the mortality. Copyright © 2010 Elsevier España, S.L. All rights reserved.

  11. Calibration test of PET scanners in a multi-centre clinical trial on breast cancer therapy monitoring using 18F-FLT.

    Directory of Open Access Journals (Sweden)

    Francis Bouchet

    Full Text Available A multi-centre trial using PET requires the analysis of images acquired on different systems We designed a multi-centre trial to estimate the value of 18F-FLT-PET to predict response to neoadjuvant chemotherapy in patients with newly diagnosed breast cancer. A calibration check of each PET-CT and of its peripheral devices was performed to evaluate the reliability of the results.11 centres were investigated. Dose calibrators were assessed by repeated measurements of a 68Ge certified source. The differences between the clocks associated with the dose calibrators and inherent to the PET systems were registered. The calibration of PET-CT was assessed with an homogeneous cylindrical phantom by comparing the activities per unit of volume calculated from the dose calibrator measurements with that measured on 15 Regions of Interest (ROIs drawn on 15 consecutive slices of reconstructed filtered back-projection (FBP images. Both repeatability of activity concentration based upon the 15 ROIs (ANOVA-test and its accuracy were evaluated.There was no significant difference for dose calibrator measurements (median of difference -0.04%; min = -4.65%; max = +5.63%. Mismatches between the clocks were less than 2 min in all sites and thus did not require any correction, regarding the half life of 18F. For all the PET systems, ANOVA revealed no significant difference between the activity concentrations estimated from the 15 ROIs (median of difference -0.69%; min = -9.97%; max = +9.60%.No major difference between the 11 centres with respect to calibration and cross-calibration was observed. The reliability of our 18F-FLT multi-centre clinical trial was therefore confirmed from the physical point of view. This type of procedure may be useful for any clinical trial involving different PET systems.

  12. Salmeterol versus slow-release theophylline combined with ketotifen in nocturnal asthma: a multicentre trial. French Multicentre Study Group.

    Science.gov (United States)

    Muir, J F; Bertin, L; Georges, D

    1992-11-01

    We wished to assess the efficacy of inhaled salmeterol (SML; 50 micrograms b.i.d.) compared to a combination of slow-release theophylline and ketotifen p.o. (TK; T 300 mg+K 1 mg b.i.d.) for the treatment of nocturnal asthma. Ninety six patients with nocturnal asthma, (forced expiratory volume in one second (FEV1) 60-90% of predicted value, reversibility > or = 15%, at least two nocturnal awakenings per week) were eligible for a multicentre, double-blind, double-dummy cross-over study (14-day run-in, two successive 28-day treatment periods). Efficacy was assessed as success/failure, success being defined as the complete disappearance of nocturnal symptoms/awakening during the last week of each treatment period. There was a statistically significant difference between SML and TK for this criterion: 46% and 39% success with SML during periods I (first 28-day period) and II (following the cross-over), compared to only 15% and 26% with TK, respectively (p < 0.01). SML was also significantly better for the other criteria (lung function, rescue salbutamol intake during day and night). Side-effects were five times less frequent in SML-treated patients (p < 0.004). Efficacy and tolerance of SML were obviously far better than those of TK in patients with nocturnal asthma.

  13. Multi-Centrality Graph Spectral Decompositions and Their Application to Cyber Intrusion Detection

    Energy Technology Data Exchange (ETDEWEB)

    Chen, Pin-Yu; Choudhury, Sutanay; Hero, Alfred

    2016-03-01

    Many modern datasets can be represented as graphs and hence spectral decompositions such as graph principal component analysis (PCA) can be useful. Distinct from previous graph decomposition approaches based on subspace projection of a single topological feature, e.g., the centered graph adjacency matrix (graph Laplacian), we propose spectral decomposition approaches to graph PCA and graph dictionary learning that integrate multiple features, including graph walk statistics, centrality measures and graph distances to reference nodes. In this paper we propose a new PCA method for single graph analysis, called multi-centrality graph PCA (MC-GPCA), and a new dictionary learning method for ensembles of graphs, called multi-centrality graph dictionary learning (MC-GDL), both based on spectral decomposition of multi-centrality matrices. As an application to cyber intrusion detection, MC-GPCA can be an effective indicator of anomalous connectivity pattern and MC-GDL can provide discriminative basis for attack classification.

  14. Quality assessment in in vivo NMR spectroscopy: V. Multicentre evaluation of prototype test objects and protocols for performance assessment in small bore MRS equipment

    DEFF Research Database (Denmark)

    Howe, F.A.; Canese, R; Podo, F

    1995-01-01

    using ISIS as volume localization sequence in 31P MRS. The results suggested the interest of adopting some of these prototypes for improving the comparison of spectroscopy data obtained from different sites, for providing useful means of quality assurance in experimental MRS, and facilitating......This paper reports the results of multicentre studies aimed at designing, constructing, and evaluating prototype test objects for performance assessment in small-bore MRS systems, by utilizing the test protocols already proposed by the EEC COMAC-BME Concerted Action for clinical MRS equipment...

  15. Development of a Multi-Centre Clinical Trial Data Archiving and Analysis Platform for Functional Imaging

    Science.gov (United States)

    Driscoll, Brandon; Jaffray, David; Coolens, Catherine

    2014-03-01

    Purpose: To provide clinicians & researchers participating in multi-centre clinical trials with a central repository for large volume dynamic imaging data as well as a set of tools for providing end-to-end testing and image analysis standards of practice. Methods: There are three main pieces to the data archiving and analysis system; the PACS server, the data analysis computer(s) and the high-speed networks that connect them. Each clinical trial is anonymized using a customizable anonymizer and is stored on a PACS only accessible by AE title access control. The remote analysis station consists of a single virtual machine per trial running on a powerful PC supporting multiple simultaneous instances. Imaging data management and analysis is performed within ClearCanvas Workstation® using custom designed plug-ins for kinetic modelling (The DCE-Tool®), quality assurance (The DCE-QA Tool) and RECIST. Results: A framework has been set up currently serving seven clinical trials spanning five hospitals with three more trials to be added over the next six months. After initial rapid image transfer (+ 2 MB/s), all data analysis is done server side making it robust and rapid. This has provided the ability to perform computationally expensive operations such as voxel-wise kinetic modelling on very large data archives (+20 GB/50k images/patient) remotely with minimal end-user hardware. Conclusions: This system is currently in its proof of concept stage but has been used successfully to send and analyze data from remote hospitals. Next steps will involve scaling up the system with a more powerful PACS and multiple high powered analysis machines as well as adding real-time review capabilities.

  16. Development of a Multi-Centre Clinical Trial Data Archiving and Analysis Platform for Functional Imaging

    International Nuclear Information System (INIS)

    Driscoll, Brandon; Jaffray, David; Coolens, Catherine

    2014-01-01

    Purpose: To provide clinicians and researchers participating in multi-centre clinical trials with a central repository for large volume dynamic imaging data as well as a set of tools for providing end-to-end testing and image analysis standards of practice. Methods: There are three main pieces to the data archiving and analysis system; the PACS server, the data analysis computer(s) and the high-speed networks that connect them. Each clinical trial is anonymized using a customizable anonymizer and is stored on a PACS only accessible by AE title access control. The remote analysis station consists of a single virtual machine per trial running on a powerful PC supporting multiple simultaneous instances. Imaging data management and analysis is performed within ClearCanvas Workstation® using custom designed plug-ins for kinetic modelling (The DCE-Tool®), quality assurance (The DCE-QA Tool) and RECIST. Results: A framework has been set up currently serving seven clinical trials spanning five hospitals with three more trials to be added over the next six months. After initial rapid image transfer (+ 2 MB/s), all data analysis is done server side making it robust and rapid. This has provided the ability to perform computationally expensive operations such as voxel-wise kinetic modelling on very large data archives (+20 GB/50k images/patient) remotely with minimal end-user hardware. Conclusions: This system is currently in its proof of concept stage but has been used successfully to send and analyze data from remote hospitals. Next steps will involve scaling up the system with a more powerful PACS and multiple high powered analysis machines as well as adding real-time review capabilities.

  17. Sensitivity of imaging for multifocal-multicentric breast carcinoma

    Directory of Open Access Journals (Sweden)

    Viale Giuseppe

    2008-09-01

    Full Text Available Abstract Background This retrospective study aims to determine: 1 the sensitivity of preoperative mammography (Mx and ultrasound (US, and re-reviewed Mx to detect multifocal multicentric breast carcinoma (MMBC, defined by pathology on surgical specimens, and 2 to analyze the characteristics of both detected and undetected foci on Mx and US. Methods Three experienced breast radiologists re-reviewed, independently, digital mammography of 97 women with MMBC pathologically diagnosed on surgical specimens. The radiologists were informed of all neoplastic foci, and blinded to the original mammograms and US reports. With regards to Mx, they considered the breast density, number of foci, the Mx characteristics of the lesions and their BI-RADS classification. For US, they considered size of the lesions, BI-RADS classification and US pattern and lesion characteristics. According to the histological size, the lesions were classified as: index cancer, 2nd lesion, 3rd lesion, and 4th lesion. Any pathologically identified malignant foci not previously described in the original imaging reports, were defined as undetected or missed lesions. Sensitivity was calculated for Mx, US and re-reviewed Mx for detecting the presence of the index cancer as well as additional satellite lesions. Results Pathological examination revealed 13 multifocal and 84 multicentric cancers with a total of 303 malignant foci (282 invasive and 21 non invasive. Original Mx and US reports had an overall sensitivity of 45.5% and 52.9%, respectively. Mx detected 83/97 index cancers with a sensitivity of 85.6%. The number of lesions undetected by original Mx was 165/303. The Mx pattern of breasts with undetected lesions were: fatty in 3 (1.8%; scattered fibroglandular density in 40 (24.3%, heterogeneously dense in 91 (55.1% and dense in 31 (18.8% cases. In breasts with an almost entirely fatty pattern, Mx sensitivity was 100%, while in fibroglandular or dense pattern it was reduced to 45

  18. Data collection using open access technology in multicentre operational research involving patient interviews.

    Science.gov (United States)

    Shewade, H D; Chadha, S S; Gupta, V; Tripathy, J P; Satyanarayana, S; Sagili, K; Mohanty, S; Bera, O P; Pandey, P; Rajeswaran, P; Jayaraman, G; Santhappan, A; Bajpai, U N; Mamatha, A M; Maiser, R; Naqvi, A J; Pandurangan, S; Nath, S; Ghule, V H; Das, A; Prasad, B M; Biswas, M; Singh, G; Mallick, G; Jeyakumar Jaisingh, A J; Rao, R; Kumar, A M V

    2017-03-21

    Conducting multicentre operational research is challenging due to issues related to the logistics of travel, training, supervision, monitoring and troubleshooting support. This is even more burdensome in resource-constrained settings and if the research includes patient interviews. In this article, we describe an innovative model that uses open access tools such as Dropbox, TeamViewer and CamScanner for efficient, quality-assured data collection in an ongoing multicentre operational research study involving record review and patient interviews. The tools used for data collection have been shared for adaptation and use by other researchers.

  19. Authorship issues in multi-centre clinical trials: the importance of making an authorship contract.

    Science.gov (United States)

    Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian; Vinther, Siri

    2015-02-01

    Discussions about authorship often arise in multi-centre clinical trials. Such trials may involve up to hundreds of contributors of whom some will eventually co-author the final publication. It is, however, often impossible to involve all contributors in the manuscript process sufficiently for them to qualify for authorship as defined by the International Committee of Medical Journal Editors. Therefore, rules for authorship in multi-centre trials are strongly recommended. We propose two contracts to prevent conflicts regarding authorship; both are freely available for use without pay but with reference to the original source.

  20. Synchronous Multicentric Giant Cell Tumour of Distal Radius and Sacrum with Pulmonary Metastases

    Directory of Open Access Journals (Sweden)

    Varun Sharma Tandra

    2015-01-01

    Full Text Available Giant cell tumour (GCT is an uncommon primary bone tumour, and its multicentric presentation is exceedingly rare. We report a case of a 45-year-old female who presented to us with GCT of left distal radius. On the skeletal survey, osteolytic lesion was noted in her right sacral ala. Biopsy confirmed both lesions as GCT. Pulmonary metastasis was also present. Resection-reconstruction arthroplasty for distal radius and thorough curettage and bone grafting of the sacral lesion were done. Multicentric GCT involving distal radius and sacrum with primary sacral involvement is not reported so far to our knowledge.

  1. Vulvar cancer in Tunisia: Epidemiological and clinicopathological features multicentric study.

    Science.gov (United States)

    Kehila, Mehdi; Harabi, Souad; Mhiri, Raoudha; Touhami, Omar; Abouda, Hassine Saber; Khlifi, Abdeljalil; Hsairi, Mohamed; Chelli, Dalenda; Derbel, Mohamed; Kebaili, Sahbi; Boujelbane, Nadia; Chaabene, Kais; Chanoufi, Mohamed Badis

    2017-06-01

    To describe for the first time the epidemiologic and clinico-pathologic characteristics of vulvar cancer in Tunisia. Two parts are distinguished in this study: Part1: Multicentric retrospective study about the characteristics of all cancer cases diagnosed during a 17-years period (January 1998-December 2014) in three departments of Gynecology and Obstetrics: one in south Tunisia and two in the capital. Part 2: To determine the Incidence trend of invasive vulvar cancer in North Tunisia 1994-2009, on the basis of North Cancer Registry of Tunisia. A total of 76 cases of vulvar cancer were recorded. The median age at diagnosis was 65.4years and 86.9% of patients were more than 55years old. The symptomatology was dominated by vulvar pruritus in 48.7%. The average size of the tumor was 3.96cm. Stage III was the most frequent (53.7%) followed by stage II (28.3%). Only 10.4% of tumors were at stage I. The most common histologic type of vulvar malignancy was squamous cell carcinoma (SCC) (94.7%). Standardized incidence varied from 1.2/100 000 (1994) to 0.5/100 000 (2009). There was significant decrease of Standardized incidence (APC of -8.8% per year, 95% CI: -5.5%, -9.0%-pTunisia is a rare disease, occurs mostly in elderly women, and is diagnosed at advanced stages. Our findings emphasize that a greater effort should be made to facilitate early diagnosis, as treatment in earlier stages is less extensive and potentially curative. Copyright © 2017 National Cancer Institute, Cairo University. Production and hosting by Elsevier B.V. All rights reserved.

  2. Surgical treatment of acute diverticulitis. A retrospective multicentre study.

    Science.gov (United States)

    Roig, José Vicente; Salvador, Antonio; Frasson, Matteo; Cantos, Míriam; Villodre, Celia; Balciscueta, Zutoia; García-Calvo, Rafael; Aguiló, Javier; Hernandis, Juan; Rodríguez, Rodolfo; Landete, Francisco; García-Granero, Eduardo

    2016-12-01

    To analyze short and medium-term results of different surgical techniques in the treatment of complicated acute diverticulitis (CAD). Multicentre retrospective study including patients operated on as surgical emergency or deferred-urgency with the diagnosis of CAD. A series of 385 patients: 218 men and 167 women, mean age 64.4±15.6 years, operated on in 10 hospitals were included. The median (25 th -75 th percentile) time from symptoms to surgery was 48 (24-72) h, being peritonitis the main surgical indication in a 66% of cases. Surgical approach was usually open (95.1%), and the commonest findings, a purulent peritonitis (34.8%) or pericolonic abscess (28.6%). Hartmann procedure (HP) was the most used technique in 278 (72.2%) patients, followed by resection and primary anastomosis (RPA) in 69 (17.9%). The overall postoperative morbidity and mortality was 53.2% and 13% respectively. Age, immunosupression, presence of general risk factors and faecal peritonitis were associated with increased mortality. Laparoscopic peritoneal lavage (LPL) was associated with an increased reoperation rate frequently involving a stoma, and anastomotic leaks presented in 13.7 patients after RPA, without differences in morbimortality when compared with HP. Median postoperative length of stay was 12 days, and was correlated with age, surgical risk, ASA score, hospital and postoperative complications. Surgery for CAD has important morbidity and mortality and is frequently associated with an end-stoma. Moreover LPL presented high reoperation rates. It seems better to resect and anastomose in most cases, even with an associated protective stoma. Copyright © 2016 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

  3. Multicentric lymphoma in buffaloes in the Amazon region, Brazil

    Directory of Open Access Journals (Sweden)

    Cairo H S De Oliveira

    2016-10-01

    Full Text Available Abstract Background The presence of lymphoma in buffaloes was first reported in India in the 1960s. The disease is similar to Enzootic Bovine Leucosis (EBL caused by Bovine leukemia virus (BLV in cattle; however, according to our results and those of other studies, the etiology of these lymphomas in buffalo do not appear to be associated with BLV. The objectives of this study are to describe four cases of the disease in buffaloes belonging to the same herd in the Amazon region of Brazil and to perform a clinical-anatomopathological, immunohistochemical, and etiological study of the lymphomas. Results Over a period of ten years, four buffaloes were observed presenting progressive weight loss, swelling of peripheral lymph nodes, and nodules in the subcutaneous tissue. Upon necropsy, whitish-colored tumor masses were observed in the form of nodules in the subcutaneous tissue, along with miliary nodules on the serosal surfaces of abdominal and thoracic organs and tumors in lymph nodes and other organs. Neoplastic lymphocyte proliferation was observed through histopathology. An immunohistochemical study revealed that the neoplasias were formed by proliferation of predominantly B lymphocytes. The presence of BLV genome was not detected in the lymphomas when using the real-time PCR technique, nor was it detected through immunohistochemical staining using monoclonal antibodies against two viral proteins. Bovine herpesvirus 6 was not detected in the tumors. However, Bovine immunodeficiency virus (BIV was detected in samples of lymphoma and in the lymph nodes and kidneys of one of the animals. Conclusions The occurrence of lymphoma in buffaloes is reported for the first time in Brazil and is characterized by B-cell multicentric lymphoma. The etiology of the disease does not appear to be associated with BLV; however, the detection of BIV in samples of lymphoma from one sick animal deserves further study, considering the oncogenic potential of this virus.

  4. Ocular and multicentric T-cell lymphoma in horse

    Directory of Open Access Journals (Sweden)

    Mariana C. Oliveira

    2016-11-01

    Full Text Available ABSTRACT. Oliveira M.C., Faleiro R.D., Santos C.C.A., Oliveira G.F., Daoualibi Y., Sonne L., Brito M.F. & Ubiali D.G. [Ocular and multicentric T-cell lymphoma in horse.] Linfoma de células T multicêntrico e ocular em equino. Revista Brasileira de Medicina Veterinária, 38(Supl.2:147-151, 2016. Setor de Anatomia Patológica, Departamento Epidemiologia e Saúde Pública, Universidade Federal Rural do Rio de Janeiro, BR 465 Km 7, Seropédica, RJ 23890-000, Brasil. E-mail: danielubiali@hotmail.com A 10-year-old gelding, mixed breed had body score condition 3 (1-10, with reluctance to move due to the loss of visual acuity in both eyes, right eye swelling and marked dyspnea. The ophthalmic examination showed no response to threat of reflection, objects test or direct reflection and consensus of both eyes. Examination with visor magnifier and Finoff transilluminator revealed buftalmia, hyphema, aqueous flare, corneal neovascularization and posterior synechiae with irregular bulging of the iris in the right eye and aqueous flare, central anterior synechiae and mature cataract in the left eye. It was found corneal integrity in both eyes with the fluorescein test. Urine sample submitted for PCR to Leptospira sp. resulted negative. Euthanasia was performed after unsuccessful treatment attempts. At necropsy there was a mass in the right eyeball, the pleural surface of the diaphragm and the mesentery. There was multifocal to coalescing whitish nodules between 1 and 4 cm in diameter in the lung, filling about 80% of the lungs’ surface, mainly in the ventral region. Morphology of masses was histopathologically compatible with lymphoma. Anti-CD3 antibody resulted positive in all samples analyzed characterizing immunophenotypic T-cell lymphoma.

  5. Impact of siltuximab on patient-related outcomes in multicentric Castleman’s disease

    Directory of Open Access Journals (Sweden)

    Sitenga J

    2018-01-01

    Full Text Available Jenna Sitenga,1 Gregory Aird,1 Aabra Ahmed,1 Peter T Silberstein2 1Division of Education, Creighton University School of Medicine, Omaha, NE, USA; 2Division of Hematology/Oncology, Creighton University School of Medicine, Omaha, NE, USA Abstract: Multicentric Castleman’s disease (MCD is a rare, widespread lymphoproliferative disorder and a life-threatening disease involving hyperactivity of the immune system, excessive proinflammatory cytokine release, immune cell proliferation, and organ system dysfunction. Interleukin-6 (IL-6 is a cytokine that plays a key role in the pathogenesis of MCD, as it is involved in the synthesis of acute-phase reactants and aids in the induction of B-cell proliferation. Siltuximab is an anti-IL-6 chimeric monoclonal antibody that acts as a novel treatment modality to bind to IL-6 with high affinity, thus neutralizing the cytokine bioactivity and inhibiting B-cell proliferation. Clinical trials with siltuximab have shown early clinical promise for patients with MCD for many years, leading to recent US Food and Drug Administration approval as a novel agent for the treatment of MCD. Here, a systematic review was conducted to include 171 cases of MCD patients treated with siltuximab. While traditional treatment methods were able to achieve a 5-year survival rate of only 55%–77%, results of siltuximab treatment demonstrated 5-year survival rates of nearly 96.4% (only 2 deaths reported out of 55 patients with follow-up data. Ultimately, the results from multiple clinical trials have demonstrated that siltuximab is extremely efficacious in alleviating disease symptoms (fatigue, pain, and lymphadenopathy while simultaneously achieving disease remission, thus extending progression-free survival for years longer than the average 5-year survival rates for MCD. Keywords: Castleman’s disease, angiofollicular lymph node hyperplasia, giant lymph node hyperplasia, siltuximab, IL-6 receptor

  6. A multicentre study of motor functional connectivity changes in patients with multiple sclerosis

    NARCIS (Netherlands)

    Valsasina, P.; Rocca, M.A.; Absinta, M.; Sormani, M.P.; Mancini, L.; De Stefano, N.; Rovira, A.; Gass, A.; Enzinger, C.; Barkhof, F.; Wegner, C.; Matthews, P.M.; Filippi, M.

    2011-01-01

    In this multicentre study involving eight European centres, we characterized the spatial pattern of functional connectivity (FC) in the sensorimotor network from 61 right-handed patients with multiple sclerosis (MS) and 74 age-matched healthy subjects assessed with the use of functional magnetic

  7. Low sodium diet and pregnancy-induced hypertension: a multi-centre randomised controlled trial

    NARCIS (Netherlands)

    Knuist, M.; Bonsel, G. J.; Zondervan, H. A.; Treffers, P. E.

    1998-01-01

    To examine the effectiveness of the standard policy in the Netherlands to prescribe a sodium restricted diet to prevent or to treat mild pregnancy-induced hypertension. Multi-centre randomised controlled trial between April 1992 and April 1994. Seven practices of independent midwives and one

  8. Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial

    NARCIS (Netherlands)

    Nauth, A. (Aaron); Creek, A.T. (Aaron T.); Zellar, A. (Abby); Lawendy, A.-R. (Abdel-Rahman); Dowrick, A. (Adam); Gupta, A. (Ajay); Dadi, A. (Akhil); A. van Kampen (A.); Yee, A. (Albert); A.C. de Vries (Alexander); de Mol van Otterloo, A. (Alexander); Garibaldi, A. (Alisha); Liew, A. (Allen); McIntyre, A.W. (Allison W.); Prasad, A.S. (Amal Shankar); Romero, A.W. (Amanda W.); Rangan, A. (Amar); Oatt, A. (Amber); Sanghavi, A. (Amir); Foley, A.L. (Amy L.); Karlsten, A. (Anders); Dolenc, A. (Andrea); Bucknill, A. (Andrew); Chia, A. (Andrew); Evans, A. (Andrew); Gong, A. (Andrew); Schmidt, A.H. (Andrew H.); Marcantonio, A.J. (Andrew J.); Jennings, A. (Andrew); Ward, A. (Angela); Khanna, A. (Angshuman); Rai, A. (Anil); Smits, A.B. (Anke B.); Horan, A.D. (Annamarie D.); Brekke, A.C. (Anne Christine); Flynn, A. (Annette); Duraikannan, A. (Aravin); Stødle, A. (Are); van Vugt, A.B. (Arie B.); Luther, A. (Arlene); Zurcher, A.W. (Arthur W.); Jain, A. (Arvind); Amundsen, A. (Asgeir); Moaveni, A. (Ash); Carr, A. (Ashley); Sharma, A. (Ateet); Hill, A.D. (Austin D.); Trommer, A. (Axel); Rai, B.S. (B. Sachidananda); Hileman, B. (Barbara); Schreurs, B. (Bart); Verhoeven, B. (Bart); Barden, B.B. (Benjamin B.); Flatøy, B. (Bernhard); B.I. Cleffken (Berry); Bøe, B. (Berthe); Perey, B. (Bertrand); Hanusch, B.C. (Birgit C.); Weening, B. (Brad); B. Fioole (Bram); Rijbroek, B. (Bram); Crist, B.D. (Brett D.); Halliday, B. (Brett); Peterson, B. (Brett); Mullis, B. (Brian); Richardson, C.G. (C. Glen); Clark, C. (Callum); Sagebien, C.A. (Carlos A.); C. van der Pol (Carmen); Bowler, C. (Carol); Humphrey, C.A. (Catherine A.); Coady, C. (Catherine); Koppert, C.L. (Cees L.); Coles, C. (Chad); Tannoury, C. (Chadi); DePaolo, C.J. (Charles J.); Gayton, C. (Chris); Herriott, C. (Chris); Reeves, C. (Christina); Tieszer, C. (Christina); Dobb, C. (Christine); Anderson, C.G. (Christopher G.); Sage, C. (Claire); Cuento, C. (Claudine); Jones, C.B. (Clifford B.); Bosman, C.H.R. (Coks H.R.); Linehan, C. (Colleen); C.P. van der Hart (Cor P.); Henderson, C. (Corey); Lewis, C.G. (Courtland G.); Davis, C.A. (Craig A.); Donohue, C. (Craig); Mauffrey, C. (Cyril); Sundaresh, D.C. (D. C.); Farrell, D.J. (Dana J.); Whelan, D.B. (Daniel B.); Horwitz, D. (Daniel); Stinner, D. (Daniel); Viskontas, D. (Darius); Roffey, D.M. (Darren M.); Alexander, D. (David); Karges, D.E. (David E.); Hak, D. (David); Johnston, D. (David); Love, D. (David); Wright, D.M. (David M.); Zamorano, D.P. (David P.); Goetz, D.R. (David R.); Sanders, D. (David); Stephen, D. (David); Yen, D. (David); Bardana, D. (Davide); Olakkengil, D.J. (Davy J); Lawson, D. (Deanna); Maddock, D. (Deborah); Sietsema, D.L. (Debra L.); Pourmand, D. (Deeba); D. den Hartog (Dennis); Donegan, D. (Derek); D. Heels-Ansdell (Diane); Nam, D. (Diane); Inman, D. (Dominic); Boyer, D. (Dory); Li, D. (Doug); Gibula, D. (Douglas); Price, D.M. (Dustin M.); Watson, D.J. (Dylan J.); Hammerberg, E.M. (E. Mark); Tan, E.T.C.H. (Edward T.C.H.); E.J.R. de Graaf (Eelco); Vesterhus, E.B. (Elise Berg); Roper, E. (Elizabeth); Edwards, E. (Elton); E.H. Schemitsch (Emil); E.R. Hammacher (Eric); Henderson, E.R. (Eric R.); Whatley, E. (Erica); Torres, E.T. (Erick T.); Vermeulen, E.G.J. (Erik G.J.); Finn, E. (Erin); E.M.M. van Lieshout (Esther); Wai, E.K. (Eugene K.); Bannister, E.R. (Evan R.); Kile, E. (Evelyn); Theunissen, E.B.M. (Evert B.M.); Ritchie, E.D. (Ewan D.); Khan, F. (Farah); Moola, F. (Farhad); Howells, F. (Fiona); F. de Nies (Frank); F.H.W.M. van der Heijden (Frank); de Meulemeester, F.R.A.J. (Frank R.A.J.); F. Frihagen (Frede); Nilsen, F. (Fredrik); Schmidt, G.B. (G. Ben); Albers, G.H.R. (G.H. Robert); Gudger, G.K. (Garland K.); Johnson, G. (Garth); Gruen, G. (Gary); Zohman, G. (Gary); Sharma, G. (Gaurav); Wood, G. (Gavin); G.W.M. Tetteroo (Geert); Hjorthaug, G. (Geir); Jomaas, G. (Geir); Donald, G. (Geoff); Rieser, G.R. (Geoffrey Ryan); Reardon, G. (Gerald); Slobogean, G.P. (Gerard P.); G.R. Roukema (Gert); Visser, G.A. (Gijs A.); Moatshe, G. (Gilbert); Horner, G. (Gillian); Rose, G. (Glynis); Guyatt, G. (Gordon); Chuter, G. (Graham); Etherington, G. (Greg); Rocca, G.J.D. (Gregory J. Della); Ekås, G. (Guri); Dobbin, G. (Gwendolyn); Lemke, H.M. (H. Michael); Curry, H. (Hamish); H. Boxma (Han); Gissel, H. (Hannah); Kreder, H. (Hans); Kuiken, H. (Hans); H.L.F. Brom; Pape, H.-C. (Hans-Christoph); H.M. van der Vis (Harm); Bedi, H. (Harvinder); Vallier, H.A. (Heather A.); Brien, H. (Heather); Silva, H. (Heather); Newman, H. (Heike); H. Viveiros (Helena); van der Hoeven, H. (Henk); Ahn, H. (Henry); Johal, H. (Herman); H. Rijna; Stockmann, H. (Heyn); Josaputra, H.A. (Hong A.); Carlisle, H. (Hope); van der Brand, I. (Igor); I. Dawson (Imro); Tarkin, I. (Ivan); Wong, I. (Ivan); Parr, J.A. (J. Andrew); Trenholm, J.A. (J. Andrew); J.C. Goslings (Carel); Amirault, J.D. (J. David); Broderick, J.S. (J. Scott); Snellen, J.P. (Jaap P.); Zijl, J.A.C. (Jacco A.C.); Ahn, J. (Jaimo); Ficke, J. (James); Irrgang, J. (James); Powell, J. (James); Ringler, J.R. (James R.); Shaer, J. (James); Monica, J.T. (James T.); J. Biert (Jan); Bosma, J. (Jan); Brattgjerd, J.E. (Jan Egil); J.P.M. Frölke (Jan Paul); J.C. Wille (Jan); Rajakumar, J. (Janakiraman); Walker, J.E. (Jane E.); Baker, J.K. (Janell K.); Ertl, J.P. (Janos P.); de Vries, J.P.P.M. (Jean Paul P.M.); Gardeniers, J.W.M. (Jean W.M.); May, J. (Jedediah); Yach, J. (Jeff); Hidy, J.T. (Jennifer T.); Westberg, J.R. (Jerald R.); Hall, J.A. (Jeremy A.); van Mulken, J. (Jeroen); McBeth, J.C. (Jessica Cooper); Hoogendoorn, J. (Jochem); Hoffman, J.M. (Jodi M.); Cherian, J.J. (Joe Joseph); Tanksley, J.A. (John A.); Clarke-Jenssen, J. (John); Adams, J.D. (John D.); Esterhai, J. (John); Tilzey, J.F. (John F.); Murnaghan, J. (John); Ketz, J.P. (John P.); Garfi, J.S. (John S.); Schwappach, J. (John); Gorczyca, J.T. (John T.); Wyrick, J. (John); Rydinge, J. (Jonas); Foret, J.L. (Jonathan L.); Gross, J.M. (Jonathan M.); Keeve, J.P. (Jonathan P.); Meijer, J. (Joost); J.J. Scheepers (Joris J.); Baele, J. (Joseph); O'Neil, J. (Joseph); Cass, J.R. (Joseph R.); Hsu, J.R. (Joseph R.); Dumais, J. (Jules); Lee, J. (Julia); Switzer, J.A. (Julie A.); Agel, J. (Julie); Richards, J.E. (Justin E.); Langan, J.W. (Justin W.); Turckan, K. (Kahn); Pecorella, K. (Kaili); Rai, K. (Kamal); Aurang, K. (Kamran); Shively, K. (Karl); K.J.P. van Wessem; Moon, K. (Karyn); Eke, K. (Kate); Erwin, K. (Katie); Milner, K. (Katrine); K.J. Ponsen (Kees-jan); Mills, K. (Kelli); Apostle, K. (Kelly); Johnston, K. (Kelly); Trask, K. (Kelly); Strohecker, K. (Kent); Stringfellow, K. (Kenya); Kruse, K.K. (Kevin K.); Tetsworth, K. (Kevin); Mitchell, K. (Khalis); Browner, K. (Kieran); Hemlock, K. (Kim); Carcary, K. (Kimberly); Jørgen Haug, K. (Knut); Noble, K. (Krista); Robbins, K. (Kristin); Payton, K. (Krystal); Jeray, K.J. (Kyle J.); Rubino, L.J. (L. Joseph); Nastoff, L.A. (Lauren A.); Leffler, L.C. (Lauren C.); L.P. Stassen (Laurents); O'Malley, L.K. (Lawrence K.); Specht, L.M. (Lawrence M.); L. Thabane (Lehana); Geeraedts, L.M.G. (Leo M.G.); Shell, L.E. (Leslie E.); Anderson, L.K. (Linda K.); Eickhoff, L.S. (Linda S.); Lyle, L. (Lindsey); Pilling, L. (Lindsey); Buckingham, L. (Lisa); Cannada, L.K. (Lisa K.); Wild, L.M. (Lisa M.); Dulaney-Cripe, L. (Liz); L.M.S.J. Poelhekke; Govaert, L. (Lonneke); Ton, L. (Lu); Kottam, L. (Lucksy); L.P.H. Leenen (Luke); Clipper, L. (Lydia); Jackson, L.T. (Lyle T.); Hampton, L. (Lynne); de Waal Malefijt, M.C. (Maarten C.); M.P. Simons; M. van der Elst (Maarten); M.W.G.A. Bronkhorst (Maarten); Bhatia, M. (Mahesh); M.F. Swiontkowski (Marc ); Lobo, M.J. (Margaret J.); Swinton, M. (Marilyn); Pirpiris, M. (Marinis); Molund, M. (Marius); Gichuru, M. (Mark); Glazebrook, M. (Mark); Harrison, M. (Mark); Jenkins, M. (Mark); MacLeod, M. (Mark); M.R. de Vries (Mark); Butler, M.S. (Mark S.); Nousiainen, M. (Markku); van ‘t Riet, M. (Martijne); Tynan, M.C. (Martin C.); Campo, M. (Martin); M.G. Eversdijk (Martin); M.J. Heetveld (Martin); Richardson, M. (Martin); Breslin, M. (Mary); Fan, M. (Mary); Edison, M. (Matt); Napierala, M. (Matthew); Knobe, M. (Matthias); Russ, M. (Matthias); Zomar, M. (Mauri); de Brauw, M. (Maurits); Esser, M. (Max); Hurley, M. (Meghan); Peters, M.E. (Melissa E.); Lorenzo, M. (Melissa); Li, M. (Mengnai); Archdeacon, M. (Michael); Biddulph, M. (Michael); Charlton, M. (Michael); McDonald, M.D. (Michael D.); McKee, M.D. (Michael D.); Dunbar, M. (Michael); Torchia, M.E. (Michael E.); Gross, M. (Michael); Hewitt, M. (Michael); Holt, M. (Michael); Prayson, M.J. (Michael J.); M.J.R. Edwards (Michael); Beckish, M.L. (Michael L.); Brennan, M.L. (Michael L.); Dohm, M.P. (Michael P.); Kain, M.S.H. (Michael S.H.); Vogt, M. (Michelle); Yu, M. (Michelle); M.H.J. Verhofstad (Michiel); Segers, M.J.M. (Michiel J.M.); M.J.M. Segers (Michiel); Siroen, M.P.C. (Michiel P.C.); M.R. Reed (Mike); Vicente, M.R. (Milena R.); M.M.M. Bruijninckx (Milko); Trivedi, M. (Mittal); M. Bhandari (Mohit); Moore, M.M. (Molly M.); Kunz, M. (Monica); Smedsrud, M. (Morten); Palla, N. (Naveen); Jain, N. (Neeraj); Out, N.J.M. (Nico J.M.); Simunovic, N. (Nicole); Simunovic, N. (Nicole); N.W.L. Schep (Niels); Müller, O. (Oliver); Guicherit, O.R. (Onno R.); O.J.F. van Waes (Oscar); Wang, O. (Otis); P. Doornebosch (Pascal); Seuffert, P. (Patricia); Hesketh, P.J. (Patrick J.); Weinrauch, P. (Patrick); Duffy, P. (Paul); Keller, P. (Paul); Lafferty, P.M. (Paul M.); Pincus, P. (Paul); P. Tornetta III (Paul); Zalzal, P. (Paul); McKay, P. (Paula); Cole, P.A. (Peter A.); de Rooij, P.D. (Peter D.); Hull, P. (Peter); Go, P.M.N.Y.M. (Peter M.N.Y.M.); P. Patka (Peter); Siska, P. (Peter); Weingarten, P. (Peter); Kregor, P. (Philip); Stahel, P. (Philip); Stull, P. (Philip); P. Wittich (Philippe); P.A.R. Rijcke (Piet); P.P. Oprel (Pim); Devereaux, P.J. (P. J.); Zhou, Q. (Qi); Lee Murphy, R. (R.); Alosky, R. (Rachel); Clarkson, R. (Rachel); Moon, R. (Raely); Logishetty, R. (Rajanikanth); Nanda, R. (Rajesh); Sullivan, R.J. (Raymond J.); Snider, R.G. (Rebecca G.); Buckley, R.E. (Richard E.); Iorio, R. (Richard); Farrugia, R.J. (Richard J); Jenkinson, R. (Richard); Laughlin, R. (Richard); R.P.R. Groenendijk (Richard); Gurich, R.W. (Richard W.); Worman, R. (Ripley); Silvis, R. (Rob); R. Haverlag (Robert); Teasdall, R.J. (Robert J.); Korley, R. (Robert); McCormack, R. (Robert); Probe, R. (Robert); Cantu, R.V. (Robert V.); Huff, R.B. (Roger B.); R.K.J. Simmermacher; Peters, R. (Rolf); Pfeifer, R. (Roman); Liem, R. (Ronald); Wessel, R.N. (Ronald N.); Verhagen, R. (Ronald); Vuylsteke, R. (Ronald); Leighton, R. (Ross); McKercher, R. (Ross); R.W. Poolman (Rudolf); Miller, R. (Russell); Bicknell, R. (Ryan); Finnan, R. (Ryan); Khan, R.M. (Ryan M.); Mehta, S. (Samir); Vang, S. (Sandy); Singh, S. (Sanjay); Anand, S. (Sanjeev); Anderson, S.A. (Sarah A.); Dawson, S.A. (Sarah A.); Marston, S.B. (Scott B.); Porter, S.E. (Scott E.); Watson, S.T. (Scott T.); S. Festen (Sebastiaan); Lieberman, S. (Shane); Puloski, S. (Shannon); Bielby, S.A. (Shea A.); Sprague, S. (Sheila); Hess, S. (Shelley); MacDonald, S. (Shelley); Evans, S. (Simone); Bzovsky, S. (Sofia); Hasselund, S. (Sondre); Lewis, S. (Sophie); Ugland, S. (Stein); Caminiti, S. (Stephanie); Tanner, S.L. (Stephanie L.); S.M. Zielinski (Stephanie); Shepard, S. (Stephanie); Sems, S.A. (Stephen A.); Walter, S.D. (Stephen D.); Doig, S. (Stephen); Finley, S.H. (Stephen H.); Kates, S. (Stephen); Lindenbaum, S. (Stephen); Kingwell, S.P. (Stephen P.); Csongvay, S. (Steve); Papp, S. (Steve); Buijk, S.E. (Steven E.); S. Rhemrev (Steven); Hollenbeck, S.M. (Steven M.); van Gaalen, S.M. (Steven M.); Yang, S. (Steven); Weinerman, S. (Stuart); Subash, (); Lambert, S. (Sue); Liew, S. (Susan); S.A.G. Meylaerts (Sven); Blokhuis, T.J. (Taco J.); de Vries Reilingh, T.S. (Tammo S.); Lona, T. (Tarjei); Scott, T. (Taryn); Swenson, T.K. (Teresa K.); Endres, T.J. (Terrence J.); Axelrod, T. (Terry); van Egmond, T. (Teun); Pace, T.B. (Thomas B.); Kibsgård, T. (Thomas); Schaller, T.M. (Thomas M.); Ly, T.V. (Thuan V.); Miller, T.J. (Timothy J.); Weber, T. (Timothy); Le, T. (Toan); Oliver, T.M. (Todd M.); T.M. Karsten (Thomas); Borch, T. (Tor); Hoseth, T.M. (Tor Magne); Nicolaisen, T. (Tor); Ianssen, T. (Torben); Rutherford, T. (Tori); Nanney, T. (Tracy); Gervais, T. (Trevor); Stone, T. (Trevor); Schrickel, T. (Tyson); Scrabeck, T. (Tyson); Ganguly, U. (Utsav); Naumetz, V. (V.); Frizzell, V. (Valda); Wadey, V. (Veronica); Jones, V. (Vicki); Avram, V. (Victoria); Mishra, V. (Vimlesh); Yadav, V. (Vineet); Arora, V. (Vinod); Tyagi, V. (Vivek); Borsella, V. (Vivian); W.J. Willems (Jaap); Hoffman, W.H. (W. H.); Gofton, W.T. (Wade T.); Lackey, W.G. (Wesley G.); Ghent, W. (Wesley); Obremskey, W. (William); Oxner, W. (William); Cross, W.W. (William W.); Murtha, Y.M. (Yvonne M.); Murdoch, Z. (Zoe)

    2017-01-01

    textabstractBackground Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled

  9. Fracture fixation in the operative management of hip fractures (FAITH) : an international, multicentre, randomised controlled trial

    NARCIS (Netherlands)

    Nauth, Aaron; Creek, Aaron T.; Zellar, Abby; Lawendy, Abdel Rahman; Dowrick, Adam; Gupta, Ajay; Dadi, Akhil; van Kampen, Albert; Yee, Albert; de Vries, Alexander C.; de Mol van Otterloo, Alexander; Garibaldi, Alisha; Liew, Allen; McIntyre, Allison W.; Prasad, Amal Shankar; Romero, Amanda W.; Rangan, Amar; Oatt, Amber; Sanghavi, Amir; Foley, Amy L.; Karlsten, Anders; Dolenc, Andrea; Bucknill, Andrew; Chia, Andrew; Evans, Andrew; Gong, Andrew; Schmidt, Andrew H.; Marcantonio, Andrew J.; Jennings, Andrew; Ward, Angela; Khanna, Angshuman; Rai, Anil; Smits, Anke B; Horan, Annamarie D.; Brekke, Anne Christine; Flynn, Annette; Duraikannan, Aravin; Stødle, Are; van Vugt, Arie B.; Luther, Arlene; Zurcher, Arthur W.; Jain, Arvind; Amundsen, Asgeir; Moaveni, Ash; Carr, Ashley; Sharma, Ateet; Hill, Austin D.; Trommer, Axel; Rai, B. Sachidananda; Hileman, Barbara; Schreurs, Bart; Verhoeven, Bart A N; Barden, Benjamin B.; Flatøy, Bernhard; Cleffken, Berry I.; Bøe, Berthe; Perey, Bertrand; Hanusch, Birgit C.; Weening, Brad; Fioole, Bram; Rijbroek, Bram; Crist, Brett D.; Halliday, Brett; Peterson, Brett; Mullis, Brian; Richardson, C. Glen; Clark, Callum; Sagebien, Carlos A.; van der Pol, Carmen C.; Bowler, Carol; Humphrey, Catherine A.; Coady, Catherine; Koppert, Cees L.; Coles, Chad; Tannoury, Chadi; DePaolo, Charles J.; Gayton, Chris; Herriott, Chris; Reeves, Christina; Tieszer, Christina; Dobb, Christine; Anderson, Christopher G.; Sage, Claire; Cuento, Claudine; Jones, Clifford B.; Bosman, Coks H.R.; Linehan, Colleen; van der Hart, Cor P.; Henderson, Corey; Lewis, Courtland G.; Davis, Craig A.; Donohue, Craig; Mauffrey, Cyril; Sundaresh, D. C.; Farrell, Dana J.; Whelan, Daniel B.; Horwitz, Daniel; Stinner, Daniel; Viskontas, Darius; Roffey, Darren M.; Alexander, David; Karges, David E.; Hak, David; Johnston, David; Love, David; Wright, David M.; Zamorano, David P.; Goetz, David R.; Sanders, David; Stephen, David; Yen, David; Bardana, Davide; Olakkengil, Davy J.; Lawson, Deanna; Maddock, Deborah; Sietsema, Debra L.; Pourmand, Deeba; Den Hartog, Dennis; Donegan, Derek; Heels-Ansdell, Diane; Nam, Diane; Inman, Dominic; Boyer, Dory; Li, Doug; Gibula, Douglas; Price, Dustin M.; Watson, Dylan J.; Hammerberg, E. Mark; Tan, Edward C T H; de Graaf, Eelco J.R.; Vesterhus, Elise Berg; Roper, Elizabeth; Edwards, Elton; Schemitsch, Emil H.; Hammacher, Eric R.; Henderson, Eric R.; Whatley, Erica; Torres, Erick T.; Vermeulen, Erik G.J.; Finn, Erin; Van Lieshout, Esther M M; Wai, Eugene K.; Bannister, Evan R.; Kile, Evelyn; Theunissen, Evert B.M.; Ritchie, Ewan D.; Khan, Farah; Moola, Farhad; Howells, Fiona; de Nies, Frank; van der Heijden, Frank H.W.M.; de Meulemeester, Frank R.A.J.; Frihagen, Frede; Nilsen, Fredrik; Schmidt, G. Ben; Albers, G. H.Robert; Gudger, Garland K.; Johnson, Garth; Gruen, Gary; Zohman, Gary; Sharma, Gaurav; Wood, Gavin; Tetteroo, Geert W.M.; Hjorthaug, Geir; Jomaas, Geir; Donald, Geoff; Rieser, Geoffrey Ryan; Reardon, Gerald; Slobogean, Gerard P.; Roukema, Gert R.; Visser, Gijs A.; Moatshe, Gilbert; Horner, Gillian; Rose, Glynis; Guyatt, Gordon; Chuter, Graham; Etherington, Greg; Rocca, Gregory J.Della; Ekås, Guri; Dobbin, Gwendolyn; Lemke, H. Michael; Curry, Hamish; Boxma, Han; Gissel, Hannah; Kreder, Hans; Kuiken, Hans; Brom, Hans L.F.; Pape, Hans Christoph; van der Vis, Harm M.; Bedi, Harvinder; Vallier, Heather A.; Brien, Heather; Silva, Heather; Newman, Heike; Viveiros, Helena; van der Hoeven, Henk; Ahn, Henry; Johal, Herman; Rijna, Herman; Stockmann, Heyn; Josaputra, Hong A.; Carlisle, Hope; van der Brand, Igor; Dawson, Imro; Tarkin, Ivan; Wong, Ivan; Parr, J. Andrew; Trenholm, J. Andrew; Goslings, J Carel; Amirault, J. David; Broderick, J. Scott; Snellen, Jaap P.; Zijl, Jacco A.C.; Ahn, Jaimo; Ficke, James; Irrgang, James; Powell, James; Ringler, James R.; Shaer, James; Monica, James T.; Biert, Jan; Bosma, Jan; Brattgjerd, Jan Egil; Frölke, Jan Paul M.; Wille, Jan; Rajakumar, Janakiraman; Walker, Jane E.; Baker, Janell K.; Ertl, Janos P.; De Vries, Jean-Paul P. M.; Gardeniers, Jean W.M.; May, Jedediah; Yach, Jeff; Hidy, Jennifer T.; Westberg, Jerald R.; Hall, Jeremy A.; van Mulken, Jeroen; McBeth, Jessica Cooper; Hoogendoorn, Jochem M; Hoffman, Jodi M.; Cherian, Joe Joseph; Tanksley, John A.; Clarke-Jenssen, John; Adams, John D.; Esterhai, John; Tilzey, John F.; Murnaghan, John; Ketz, John P.; Garfi, John S.; Schwappach, John; Gorczyca, John T.; Wyrick, John; Rydinge, Jonas; Foret, Jonathan L.; Gross, Jonathan M.; Keeve, Jonathan P.; Meijer, Joost; Scheepers, Joris J.G.; Baele, Joseph; O'Neil, Joseph; Cass, Joseph R.; Hsu, Joseph R.; Dumais, Jules; Lee, Julia; Switzer, Julie A.; Agel, Julie; Richards, Justin E.; Langan, Justin W.; Turckan, Kahn; Pecorella, Kaili; Rai, Kamal; Aurang, Kamran; Shively, Karl; van Wessem, Karlijn; Moon, Karyn; Eke, Kate; Erwin, Katie; Milner, Katrine; Ponsen, Kees Jan; Mills, Kelli; Apostle, Kelly; Johnston, Kelly; Trask, Kelly; Strohecker, Kent; Stringfellow, Kenya; Kruse, Kevin K.; Tetsworth, Kevin; Mitchell, Khalis; Browner, Kieran; Hemlock, Kim; Carcary, Kimberly; Jørgen Haug, Knut; Noble, Krista; Robbins, Kristin; Payton, Krystal; Jeray, Kyle J.; Rubino, L. Joseph; Nastoff, Lauren A.; Leffler, Lauren C.; Stassen, Laurents P.S.; O'Malley, Lawrence K.; Specht, Lawrence M.; Thabane, Lehana; Geeraedts, Leo M.G.; Shell, Leslie E.; Anderson, Linda K.; Eickhoff, Linda S.; Lyle, Lindsey; Pilling, Lindsey; Buckingham, Lisa; Cannada, Lisa K.; Wild, Lisa M.; Dulaney-Cripe, Liz; Poelhekke, Lodewijk M.S.J.; Govaert, Lonneke; Ton, Lu; Kottam, Lucksy; Leenen, Luke P.H.; Clipper, Lydia; Jackson, Lyle T.; Hampton, Lynne; de Waal Malefijt, Maarten C.; Simons, Maarten P.; van der Elst, Maarten; Bronkhorst, Maarten W.G.A.; Bhatia, Mahesh; Swiontkowski, Marc; Lobo, Margaret J.; Swinton, Marilyn; Pirpiris, Marinis; Molund, Marius; Gichuru, Mark; Glazebrook, Mark; Harrison, Mark; Jenkins, Mark; MacLeod, Mark; de Vries, Mark R.; Butler, Mark S.; Nousiainen, Markku; van ‘t Riet, Martijne; Tynan, Martin C.; Campo, Martin; Eversdijk, Martin G.; Heetveld, Martin J.; Richardson, Martin; Breslin, Mary; Fan, Mary; Edison, Matt; Napierala, Matthew; Knobe, Matthias; Russ, Matthias; Zomar, Mauri; de Brauw, Maurits; Esser, Max; Hurley, Meghan; Peters, Melissa E.; Lorenzo, Melissa; Li, Mengnai; Archdeacon, Michael; Biddulph, Michael; Charlton, Michael R; McDonald, Michael D.; McKee, Michael D.; Dunbar, Michael; Torchia, Michael E.; Gross, Michael; Hewitt, Michael; Holt, Michael; Prayson, Michael J.; Edwards, Michael J R; Beckish, Michael L.; Brennan, Michael L.; Dohm, Michael P.; Kain, Michael S.H.; Vogt, Michelle; Yu, Michelle; Verhofstad, Michiel H J; Segers, Michiel J M; Segers, Michiel J M; Siroen, Michiel P.C.; Reed, Mike; Vicente, Milena R.; Bruijninckx, Milko M.M.; Trivedi, Mittal; Bhandari, Mohit; Moore, Molly M.; Kunz, Monica; Smedsrud, Morten; Palla, Naveen; Jain, Neeraj; Out, Nico J.M.; Simunovic, Nicole; Simunovic, Nicole; Schep, Niels W. L.; Müller, Oliver; Guicherit, Onno R.; Van Waes, Oscar J.F.; Wang, Otis; Doornebosch, Pascal G.; Seuffert, Patricia; Hesketh, Patrick J.; Weinrauch, Patrick; Duffy, Paul; Keller, Paul; Lafferty, Paul M.; Pincus, Paul; Tornetta, Paul; Zalzal, Paul; McKay, Paula; Cole, Peter A.; de Rooij, Peter D.; Hull, Peter; Go, Peter M.N.Y.M.; Patka, Peter; Siska, Peter; Weingarten, Peter; Kregor, Philip; Stahel, Philip; Stull, Philip; Wittich, Philippe; de Rijcke, Piet A.R.; Oprel, Pim; Devereaux, P. J.; Zhou, Qi; Lee Murphy, R.; Alosky, Rachel; Clarkson, Rachel; Moon, Raely; Logishetty, Rajanikanth; Nanda, Rajesh; Sullivan, Raymond J.; Snider, Rebecca G.; Buckley, Richard E.; Iorio, Richard; Farrugia, Richard J.; Jenkinson, Richard; Laughlin, Richard; Groenendijk, Richard P R; Gurich, Richard W.; Worman, Ripley; Silvis, Rob; Haverlag, Robert; Teasdall, Robert J.; Korley, Robert; McCormack, Robert; Probe, Robert; Cantu, Robert V.; Huff, Roger B.; Simmermacher, Rogier K J; Peters, Rolf; Pfeifer, Roman; Liem, Ronald; Wessel, Ronald N.; Verhagen, Ronald; Vuylsteke, Ronald J C L M; Leighton, Ross; McKercher, Ross; Poolman, Rudolf W; Miller, Russell; Bicknell, Ryan; Finnan, Ryan; Khan, Ryan M.; Mehta, Samir; Vang, Sandy; Singh, Sanjay; Anand, Sanjeev; Anderson, Sarah A.; Dawson, Sarah A.; Marston, Scott B.; Porter, Scott E.; Watson, Scott T.; Festen, Sebastiaan; Lieberman, Shane; Puloski, Shannon; Bielby, Shea A.; Sprague, Sheila; Hess, Shelley; MacDonald, Shelley; Evans, Simone; Bzovsky, Sofia; Hasselund, Sondre; Lewis, Sophie; Ugland, Stein; Caminiti, Stephanie; Tanner, Stephanie L.; Zielinski, Stephanie M.; Shepard, Stephanie; Sems, Stephen A.; Walter, Stephen D.; Doig, Stephen; Finley, Stephen H.; Kates, Stephen; Lindenbaum, Stephen; Kingwell, Stephen P.; Csongvay, Steve; Papp, Steve; Buijk, Steven E.; Rhemrev, Steven J.; Hollenbeck, Steven M.; van Gaalen, Steven M.; Yang, Steven; Weinerman, Stuart; Lambert, Sue; Liew, Susan; Meylaerts, Sven A.G.; Blokhuis, Taco J.; de Vries Reilingh, Tammo S.; Lona, Tarjei; Scott, Taryn; Swenson, Teresa K.; Endres, Terrence J.; Axelrod, Terry; van Egmond, Teun; Pace, Thomas B.; Kibsgård, Thomas; Schaller, Thomas M.; Ly, Thuan V.; Miller, Timothy J.; Weber, Timothy; Le, Toan; Oliver, Todd M.; Karsten, Tom M.; Borch, Tor; Hoseth, Tor Magne; Nicolaisen, Tor; Ianssen, Torben; Rutherford, Tori; Nanney, Tracy; Gervais, Trevor; Stone, Trevor; Schrickel, Tyson; Scrabeck, Tyson; Ganguly, Utsav; Naumetz, V.; Frizzell, Valda; Wadey, Veronica; Jones, Vicki; Avram, Victoria; Mishra, Vimlesh; Yadav, Vineet; Arora, Vinod; Tyagi, Vivek; Borsella, Vivian; Willems, W. Jaap; Hoffman, W. H.; Gofton, Wade T.; Lackey, Wesley G.; Ghent, Wesley; Obremskey, William; Oxner, William; Cross, William W.; Murtha, Yvonne M.; Murdoch, Zoe

    2017-01-01

    Background Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we

  10. Multicentre evaluation of the Tosoh HbA1c G8 analyser

    NARCIS (Netherlands)

    Chapelle, Jean-Paul; Teixeira, Jelda; Maisin, Diane; Assink, Hans; Barla, Gerhard; Stroobants, An K.; Delzenne, Barend; van den Eshof, Wouter

    2010-01-01

    We report a Dutch-Belgian multicentre evaluation of the Tosoh HLC-723G8 glycohaemoglobin analyser, an ion-exchange HPLC instrument for the separation and quantification of haemoglobin A1c (HbA1c) in whole blood. We evaluated the analytical performances of the Tosoh G8 analyser and compared the

  11. Loss to follow-up in an international, multicentre observational study

    DEFF Research Database (Denmark)

    Mocroft, A; Kirk, O; Aldins, P

    2008-01-01

    OBJECTIVE: The aim of this work was to assess loss to follow-up (LTFU) in EuroSIDA, an international multicentre observational cohort study. METHODS: LTFU was defined as no follow-up visit, CD4 cell count measurement or viral load measurement after 1 January 2006. Poisson regression was used...

  12. The Transfusion Alternatives Preoperatively in Sickle Cell Disease (TAPS) study: a randomised, controlled, multicentre clinical trial

    NARCIS (Netherlands)

    Howard, Jo; Malfroy, Moira; Llewelyn, Charlotte; Choo, Louise; Hodge, Renate; Johnson, Tony; Purohit, Shilpi; Rees, David C.; Tillyer, Louise; Walker, Isabeau; Fijnvandraat, Karin; Kirby-Allen, Melanie; Spackman, Eldon; Davies, Sally C.; Williamson, Lorna M.

    2013-01-01

    No consensus exists on whether preoperative blood transfusions are beneficial in patients with sickle-cell disease. We assessed whether perioperative complication rates would be altered by preoperative transfusion. We did a multicentre, randomised trial. Eligible patients were aged at least 1 year,

  13. Gastro-oesophageal reflux disease in The Netherlands. Results of a multicentre pH study

    NARCIS (Netherlands)

    Smout, A. J.; Geus, W. P.; Mulder, P. G.; Stockbrügger, R. W.; Lamers, C. B.

    1996-01-01

    Information on the relationships between gastro-oesophageal reflux (GOR), reflux symptoms, hiatal hernia (HH) and oesophagitis, and the response to antisecretory treatment is lacking. In a multicentre study endoscopy, ambulatory 24-h pH monitoring and symptom assessment were carried out in 142

  14. Evaluation of the preliminary auditory profile test battery in an international multi-centre study

    NARCIS (Netherlands)

    van Esch, T.E.M.; Kollmeier, B.; Vormann, M.; Lijzenga, J.; Houtgast, T.; Hallgren, M.; Larsby, B.; Athalye, S.P.; Lutman, M.E.; Dreschler, W.A.

    2013-01-01

    Objective: This paper describes the composition and international multi-centre evaluation of a battery of tests termed the preliminary auditory profile. It includes measures of loudness perception, listening effort, speech perception, spectral and temporal resolution, spatial hearing, self-reported

  15. Evaluation of the preliminary auditory profile test battery in an international multi-centre study

    NARCIS (Netherlands)

    van Esch, Thamar E. M.; Kollmeier, Birger; Vormann, Matthias; Lyzenga, Johannes; Houtgast, Tammo; Hällgren, Mathias; Larsby, Birgitta; Athalye, Sheetal P.; Lutman, Mark E.; Dreschler, Wouter A.

    2013-01-01

    This paper describes the composition and international multi-centre evaluation of a battery of tests termed the preliminary auditory profile. It includes measures of loudness perception, listening effort, speech perception, spectral and temporal resolution, spatial hearing, self-reported disability

  16. An international multicentre study on the allergenic activity of air-oxidized R-limonene

    DEFF Research Database (Denmark)

    Bråred Christensson, Johanna; Andersen, Klaus; Bruze, Magnus

    2013-01-01

    Limonene is a common fragrance terpene that, in its pure form, is not allergenic or is a very weak allergen. However, limonene autoxidizes on air exposure, and the oxidation products can cause contact allergy. Oxidized R-limonene has previously been patch tested in multicentre studies, giving 2-3...

  17. Case report 558: Multicentric Klebsiella pneumoniae (Friedlaenders bacillus) osteomyelitis in sickle cell anemia

    Energy Technology Data Exchange (ETDEWEB)

    Malpani, A.R.; Sundaram, M. (Saint Louis Univ., MO (USA). Dept. of Radiology and Orthopedics); Ramani, S.K. (Grant Medical Coll., Bombay (India). Dept. of Radiology)

    1989-08-01

    This patient represents a unique combination of multicentric osteomyelitis due to Klebsiella pneumoniae, lesions in the skull, pathological fracture of a long bone and no evidence of pulmonary disease. That Klebsiella pneumoniae osteomyelitis can occur in sickle cell anemia should be considered when such bone changes are seen. The remarkable resolution on conservative management also needs to be noted. (orig./GDG).

  18. Lung volume reduction coil treatment for patients with severe emphysema : a European multicentre trial

    NARCIS (Netherlands)

    Deslee, Gaetan; Klooster, Karin; Hetzel, Martin; Stanzel, Franz; Kessler, Romain; Marquette, Charles-Hugo; Witt, Christian; Blaas, Stefan; Gesierich, Wolfgang; Herth, Felix J. F.; Hetzel, Juergen; van Rikxoort, Eva M.; Slebos, Dirk-Jan

    2014-01-01

    Background The lung volume reduction (LVR) coil is a minimally invasive bronchoscopic nitinol device designed to reduce hyperinflation and improve elastic recoil in severe emphysema. We investigated the feasibility, safety and efficacy of LVR coil treatment in a prospective multicentre cohort trial

  19. Daily variations in air pollution and respiratory health in a multicentre study: the PEACE project.

    NARCIS (Netherlands)

    Roemer, W.; Hoek, G.; Brunekreef, B.; Haluszka, J.; Kalandidi, A.; Pekkanen, J.

    1998-01-01

    The Pollution Effects on Asthmatic Children in Europe (PEACE) study is a multicentre study of the acute effects of particles with a 50% cut-off aerodynamic diameter of 10 μm (PM10), black smoke (BS), sulphur dioxide (SO2) and nitrogen dioxide (NO2) on the respiratory health of children with chronic

  20. Dislocation of the elbow: a retrospective multicentre study of 86 patients

    NARCIS (Netherlands)

    de Haan, Jeroen; Schep, Niels W. L.; Zengerink, Imme; van Buijtenen, Jesse; Tuinebreijer, Wim E.; den Hartog, Dennis

    2010-01-01

    The objective of this retrospective multicentre cohort study was to prospectively assess the long-term functional outcomes of simple and complex elbow dislocations.We analysed the hospital and outpatient records of 86 patients between 01.03.1999 and 25.02.2009 with an elbow dislocation. After a mean

  1. Dislocation of the Elbow: A Retrospective Multicentre Study of 86 Patients

    NARCIS (Netherlands)

    J. de Haan (Jeroen); J.F. Zengerink; D. den Hartog (Dennis); W.E. Tuinebreijer (Wim); J. Buijtenen (Jesse van); N.W.L. Schep (Niels)

    2010-01-01

    textabstractThe objective of this retrospective multicentre cohort study was to prospectively assess the long-term functional outcomes of simple and complex elbow dislocations.We analysed the hospital and outpatient records of 86 patients between 01.03.1999 and 25.02.2009 with an elbow dislocation.

  2. Prophylactic antibiotic regimens in tumour surgery (PARITY) : a pilot multicentre randomised controlled trial

    NARCIS (Netherlands)

    Ghert, M.; Bhandari, M.; Deheshi, B.; Guyatt, G.; Holt, G.; O'Shea, T.; Randall, R. L.; Thabane, L.; Wunder, J.; Evaniew, N.; McKay, P.; Schneider, P.; Turcotte, R.; Madden, K.; Scott, T.; Sprague, S.; Simunovic, N.; Swinton, M.; Racano, A.; Heels-Ansdell, D.; Buckingham, L.; Rose, P.; Brigman, B.; Pullenayegum, E.; Ghert, M.; Evaniew, N.; Mckay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Biljan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.

    2015-01-01

    Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a

  3. Prophylactic efficacy of lithium administered every second day: a WHO multicentre study

    DEFF Research Database (Denmark)

    Plenge, P; Amin, M; Agarwal, A K

    1999-01-01

    OBJECTIVES: To study the prophylactic efficacy of lithium administered every second day to patients with bipolar disorder or recurrent unipolar depressive disorder. METHODS: The study was carried out as a WHO multicentre study in five different psychiatric clinics: Russia (Moscow), Canada (Montre...

  4. Telemedicine techniques can be used to facilitate the conduct of multicentre trials.

    Science.gov (United States)

    Kennedy, C; Kirwan, J; Cook, C; Roux, P; Stulting, A; Murdoch, I

    2000-01-01

    A multicentre randomized controlled trial was established in Pretoria, Bloemfontein and Edendale in South Africa, and coordinated from London. The purpose of the trial was to determine the efficacy of low-dose beta irradiation of glaucoma. Five communication modalities (telephone, fax, e-mail, videoconferencing and face-to-face meetings) were examined in terms of their benefits in a multicentre trial. The eight stages of the multicentre trial examined were: set-up and training, recruitment, standardization, patient management, data transmission, update and data dissemination, clinical follow-up and monitoring, and publication. On four-point Likert scales for rating the usefulness of the communication modalities at each of the eight stages of the trial (from 0 = not useful to 3 = very useful; maximum score 24) the telephone was given a total score of 10, fax 9, e-mail 13, videoconferencing 15 and face-to-face meetings 9. Telemedicine techniques offer considerable benefits in the coordination of multicentre trials by improving data collection, maintaining the efficacy and monitoring of trials, while potentially offering reduced costs in terms of travel and time. The realtime scrutiny of patient records helps to ensure data uniformity and completeness of data collection. Videoconferencing was most useful when considered as one of several communication tools that can be used to improve the effectiveness of a service or process.

  5. Multicentre evaluation of a novel vaginal dose reporting method in 153 cervical cancer patients

    NARCIS (Netherlands)

    Westerveld, Henrike; de Leeuw, Astrid; Kirchheiner, Kathrin; Dankulchai, Pittaya; Oosterveld, Bernard; Oinam, Arun; Hudej, Robert; Swamidas, Jamema; Lindegaard, Jacob; Tanderup, Kari; Pötter, Richard; Kirisits, Christian

    2016-01-01

    Recently, a vaginal dose reporting method for combined EBRT and BT in cervical cancer patients was proposed. The current study was to evaluate vaginal doses with this method in a multicentre setting, wherein different applicators, dose rates and protocols were used. In a subset of patients from the

  6. Multicentre European study of thalamic stimulation for parkinsonian tremor: a 6 year follow-up

    NARCIS (Netherlands)

    Hariz, M. I.; Krack, P.; Alesch, F.; Augustinsson, L.-E.; Bosch, A.; Ekberg, R.; Johansson, F.; Johnels, B.; Meyerson, B. A.; N'Guyen, J.-P.; Pinter, M.; Pollak, P.; von Raison, F.; Rehncrona, S.; Speelman, J. D.; Sydow, O.; Benabid, A.-L.

    2008-01-01

    To evaluate the results of ventral intermediate (Vim) thalamic deep brain stimulation (DBS) in patients with tremor predominant Parkinson's disease (PD) at 6 years post surgery. This was a prolonged follow-up study of 38 patients from eight centres who participated in a multicentre study, the 1 year

  7. Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies.

    NARCIS (Netherlands)

    Halder, Marlies; Depraetere, Hilde; Delannois, Frédérique; Akkermans, Arnoud; Behr-Gross, Marie-Emmanuelle; Bruysters, Martijn; Dierick, Jean-François; Jungbäck, Carmen; Kross, Imke; Metz, Bernard; Pennings, Jeroen; Rigsby, Peter; Riou, Patrice; Balks, Elisabeth; Dobly, Alexandre; Leroy, Odile; Stirling, Catrina

    2018-01-01

    Within the Innovative Medicines Initiative 2 (IMI 2) project VAC2VAC (Vaccine batch to vaccine batch comparison by consistency testing), a workshop has been organised to discuss ways of improving the design of multi-centre validation studies and use the data generated for product-specific validation

  8. Case report 558: Multicentric Klebsiella pneumoniae (Friedlaenders bacillus) osteomyelitis in sickle cell anemia

    International Nuclear Information System (INIS)

    Malpani, A.R.; Sundaram, M.; Ramani, S.K.

    1989-01-01

    This patient represents a unique combination of multicentric osteomyelitis due to Klebsiella pneumoniae, lesions in the skull, pathological fracture of a long bone and no evidence of pulmonary disease. That Klebsiella pneumoniae osteomyelitis can occur in sickle cell anemia should be considered when such bone changes are seen. The remarkable resolution on conservative management also needs to be noted. (orig./GDG)

  9. Proposal for the standardisation of multi-centre trials in nuclear medicine imaging

    DEFF Research Database (Denmark)

    Dickson, John Caddell; Tossici-Bolt, Livia; Sera, Terez

    2012-01-01

    Multi-centre trials are an important part of proving the efficacy of procedures, drugs and interventions. Imaging components in such trials are becoming increasingly common; however, without sufficient control measures the usefulness of these data can be compromised. This paper describes a framew...

  10. Violent women : A multicentre study into gender differences in forensic psychiatric patients

    NARCIS (Netherlands)

    de Vogel, Vivienne; Stam, Jeantine; Bouman, Yvonne H. A.; Ter Horst, P.R.M.; Lancel, Marike

    2016-01-01

    To gain insight into the relatively small, but increasing group of women in forensic psychiatry, a retrospective multicentre study was started gathering information from the files of 275 female patients of four Dutch forensic psychiatric hospitals on characteristics and violence risk factors.

  11. Active LifestyLe Rehabilitation interventions in aging spinal cord injury (ALLRISC): a multicentre research program.

    Science.gov (United States)

    van der Woude, L H V; de Groot, S; Postema, K; Bussmann, J B J; Janssen, T W J; Post, M W M

    2013-06-01

    With today's specialized medical care, life expectancy of persons with a spinal cord injury (SCI) has considerably improved. With increasing age and time since injury, many individuals with SCI, however, show a serious inactive lifestyle, associated with deconditioning and secondary health conditions (SHCs) (e.g. pressure sores, urinary and respiratory tract infections, osteoporosis, upper-extremity pain, obesity, diabetes, cardiovascular disease) and resulting in reduced participation and quality of life (QoL). Avoiding this downward spiral, is crucial. To understand possible deconditioning and SHCs in persons aging with a SCI in the context of active lifestyle, fitness, participation and QoL and to examine interventions that enhance active lifestyle, fitness, participation and QoL and help prevent some of the SHCs. A multicentre multidisciplinary research program (Active LifestyLe Rehabilitation Interventions in aging Spinal Cord injury, ALLRISC) in the setting of the long-standing Dutch SCI-rehabilitation clinical research network. ALLRISC is a four-study research program addressing inactive lifestyle, deconditioning, and SHCs and their associations in people aging with SCI. The program consists of a cross-sectional study (n = 300) and three randomized clinical trials. All studies share a focus on fitness, active lifestyle, SHCs and deconditioning and outcome measures on these and other (participation, QoL) domains. It is hypothesized that a self-management program, low-intensity wheelchair exercise and hybrid functional electrical stimulation-supported leg and handcycling are effective interventions to enhance active life style and fitness, help to prevent some of the important SHCs in chronic SCI and improve participation and QoL. ALLRISC aims to provide evidence-based preventive components of a rehabilitation aftercare system that preserves functioning in aging persons with SCI.

  12. Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery

    Directory of Open Access Journals (Sweden)

    Bochenek Andrzej

    2011-09-01

    Full Text Available Abstract Background ART is a multi-centre randomised trial of cardiac surgery which provided a unique opportunity to evaluate the data from a large number of centres from a variety of countries. We attempted to assess data quality, including recruitment rates, timeliness and completeness of the data obtained from the centres in different socio-economic strata. Methods The analysis was based on the 2-page CRF completed at the 6 week follow-up. CRF pages were categorised into "clean" (no edit query and "dirty" (any incomplete, inconsistent or illegible data. The timelines were assessed on the basis of the time interval from the visit and receipt of complete CRF. Data quality was defined as the number of data queries (in percent and time delay (in days between visit and receipt of correct data. Analyses were stratified according to the World Bank definitions into: "Developing" countries (Poland, Brazil and India and "Developed" (Italy, UK, Austria and Australia. Results There were 18 centres in the "Developed" and 10 centres in the "Developing" countries. The rate of enrolment did not differ significantly by economic level ("Developing":4.1 persons/month, "Developed":3.7 persons/month. The time interval for the receipt of data was longer for "Developing" countries (median:37 days compared to "Developed" ones (median:11 days (p Conclusions In this study we showed that data quality was comparable between centres from "Developed" and "Developing" countries. Data was received in a less timely fashion from Developing countries and appropriate systems should be instigated to minimize any delays. Close attention should be paid to the training of centres and to the central management of data quality. Trial registration ISRCTN46552265

  13. Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Santos-Rey Koldo

    2011-02-01

    Full Text Available Abstract Background Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life. Methods/design Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment. Discussion This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression. Trial registration ISRCTN trial number

  14. Right Iliac Fossa Pain Treatment (RIFT) Study: protocol for an international, multicentre, prospective observational study.

    Science.gov (United States)

    2018-01-13

    Patients presenting with right iliac fossa (RIF) pain are a common challenge for acute general surgical services. Given the range of potential pathologies, RIF pain creates diagnostic uncertainty and there is subsequent variation in investigation and management. Appendicitis is a diagnosis which must be considered in all patients with RIF pain; however, over a fifth of patients undergoing appendicectomy, in the UK, have been proven to have a histologically normal appendix (negative appendicectomy). The primary aim of this study is to determine the contemporary negative appendicectomy rate. The study's secondary aims are to determine the rate of laparoscopy for appendicitis and to validate the Appendicitis Inflammatory Response (AIR) and Alvarado prediction scores. This multicentre, international prospective observational study will include all patients referred to surgical specialists with either RIF pain or suspected appendicitis. Consecutive patients presenting within 2-week long data collection periods will be included. Centres will be invited to participate in up to four data collection periods between February and August 2017. Data will be captured using a secure online data management system. A centre survey will profile local policy and service delivery for management of RIF pain. Research ethics are not required for this study in the UK, as determined using the National Research Ethics Service decision tool. This study will be registered as a clinical audit in participating UK centres. National leads in countries outside the UK will oversee appropriate registration and study approval, which may include completing full ethical review. The study will be disseminated by trainee-led research collaboratives and through social media. Peer-reviewed publications will be published under corporate authorship including 'RIFT Study Group' and 'West Midlands Research Collaborative'. © Article author(s) (or their employer(s) unless otherwise stated in the text of the

  15. Prevalence of β-thalassemia and other haemoglobinopathies in six cities in India: a multicentre study.

    Science.gov (United States)

    Mohanty, D; Colah, R B; Gorakshakar, A C; Patel, R Z; Master, D C; Mahanta, J; Sharma, S K; Chaudhari, U; Ghosh, M; Das, S; Britt, R P; Singh, S; Ross, C; Jagannathan, L; Kaul, R; Shukla, D K; Muthuswamy, V

    2013-01-01

    The population of India is extremely diverse comprising of more than 3,000 ethnic groups who still follow endogamy. Haemoglobinopathies are the commonest hereditary disorders in India and pose a major health problem. The data on the prevalence of β-thalassemias and other haemoglobinopathies in different caste/ethnic groups of India is scarce. Therefore the present multicentre study was undertaken in six cities of six states of India (Maharashtra, Gujarat, West Bengal, Assam, Karnataka and Punjab) to determine the prevalence of haemoglobinopathies in different caste/ethnic groups using uniform methodology. Fifty-six thousand seven hundred eighty individuals (college students and pregnant women) from different caste/ethnic groups were screened. RBC indices were measured on an automated haematology counter while the percentage of HbA(2), HbF and other abnormal Hb variants were estimated by HPLC on the Variant Hemoglobin Testing System. The overall prevalence of β-thalassemia trait was 2.78 % and varied from 1.48 to 3.64 % in different states, while the prevalence of β-thalassemia trait in 59 ethnic groups varied from 0 to 9.3 %. HbE trait was mainly seen in Dibrugarh in Assam (23.9 %) and Kolkata in West Bengal (3.92 %). In six ethnic groups from Assam, the prevalence of HbE trait varied from 41.1 to 66.7 %. Few subjects with δβ-thalassemia, HPFH, HbS trait, HbD trait, HbE homozygous and HbE β-thalassemia as well as HbS homozygous and HbS-β-thalassemia (India.

  16. Round block technique is a useful oncoplastic procedure for multicentric fibroadenomas.

    Science.gov (United States)

    Lai, Hung-Wen; Kuo, Yao-Lung; Su, Chin-Chen; Chen, Chih-Jung; Kuo, Sou-Jen; Chen, Shou-Tung; Chen, Dar-Ren

    2016-02-01

    Multicentric fibroadenomas, defined as multiple fibroadenomas located at different quadrants of the breast, occur in 10-20% of women with fibroadenoma. The surgical management of multicentric fibroadenomas may be troublesome for surgeons and patients. In this study, we report our preliminary experience using the "round block technique" in the management of women with multicentric fibroadenomas of the breast. Records of patients with breast diseases managed with the round block technique were searched for in the Changhua Christian Hospital oncoplastic breast surgery database. The patients' clinicopathologic characteristics, type of surgery, operation time, blood loss, and complications were recorded. The cosmetic outcome was evaluated by the patient and operating surgeon two months after the surgery. Twenty patients with multicentric fibroadenomas managed by the round block technique comprised the current study cohort. The mean age of the subjects was 36.5 ± 10.4 years. Twelve (60%) patients had tumors on one side of the breast, and eight (40%) had bilateral breast lesions. The average number of tumors removed was 3.3 ± 1.2 (range 2-6) per breast, and mean tumor size was 2.2 ± 0.5 cm. Three (15%) patients developed mild ecchymosis of the breast undergoing operation, which resolved spontaneously. One (5%) patient had partial nipple ischemia/necrosis due to 2 tumors excised near the nipple-areolar complex. The aesthetic results were evaluated as good in 19 (95%) patients and fair in 1 (5%). The round block technique is a useful oncoplastic procedure for the management of multicentric fibroadenomas excised at the same time. Copyright © 2014 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.

  17. Defining safe criteria to diagnose miscarriage: prospective observational multicentre study

    Science.gov (United States)

    Preisler, Jessica; Kopeika, Julia; Ismail, Laure; Vathanan, Veluppillai; Farren, Jessica; Abdallah, Yazan; Battacharjee, Parijat; Van Holsbeke, Caroline; Bottomley, Cecilia; Gould, Deborah; Johnson, Susanne; Stalder, Catriona; Van Calster, Ben; Hamilton, Judith; Timmerman, Dirk

    2015-01-01

    Objectives To validate recent guidance changes by establishing the performance of cut-off values for embryo crown-rump length and mean gestational sac diameter to diagnose miscarriage with high levels of certainty. Secondary aims were to examine the influence of gestational age on interpretation of mean gestational sac diameter and crown-rump length values, determine the optimal intervals between scans and findings on repeat scans that definitively diagnose pregnancy failure.) Design Prospective multicentre observational trial. Setting Seven hospital based early pregnancy assessment units in the United Kingdom. Participants 2845 women with intrauterine pregnancies of unknown viability included if transvaginal ultrasonography showed an intrauterine pregnancy of uncertain viability. In three hospitals this was initially defined as an empty gestational sac <20 mm mean diameter with or without a visible yolk sac but no embryo, or an embryo with crown-rump length <6 mm with no heartbeat. Following amended guidance in December 2011 this definition changed to a gestational sac size <25 mm or embryo crown-rump length <7 mm. At one unit the definition was extended throughout to include a mean gestational sac diameter <30 mm or embryo crown-rump length <8 mm. Main outcome measures Mean gestational sac diameter, crown-rump length, and presence or absence of embryo heart activity at initial and repeat transvaginal ultrasonography around 7-14 days later. The final outcome was pregnancy viability at 11-14 weeks’ gestation. Results The following indicated a miscarriage at initial scan: mean gestational sac diameter ≥25 mm with an empty sac (364/364 specificity: 100%, 95% confidence interval 99.0% to 100%), embryo with crown-rump length ≥7 mm without visible embryo heart activity (110/110 specificity: 100%, 96.7% to 100%), mean gestational sac diameter ≥18 mm for gestational sacs without an embryo presenting after 70 days’ gestation (907/907 specificity: 100%, 99.6% to

  18. E-learning in radiology: an Italian multicentre experience.

    Science.gov (United States)

    Carriero, A; Bonomo, L; Calliada, F; Campioni, P; Colosimo, C; Cotroneo, A; Cova, M; Ettorre, G C; Fugazzola, C; Garlaschi, G; Macarini, L; Mascalchi, M; Meloni, G B; Midiri, M; Mucelli, R Pozzi; Rossi, C; Sironi, S; Torricelli, P; Beomonte, B Zobel; Zompatori, M; Zuiani, C

    2012-12-01

    overcoming all barriers, and technology is also having a positive impact on the approach to teaching. Our multicentre teaching experience merits the following considerations: the quality of the teaching product was certified by the students' judgements of its didactic content and the quality of reception; the economic cost of the teaching had a minimal impact on the post-graduate schools (€ 18 per lesson). In terms of breaking down national barriers, it is to be hoped that the coordination and integration of diagnostic imaging e-learning projects, with the participation of post-graduate schools in different European countries, can be developed not only in a spirit of "cultural sharing" and the exchange of teaching experiences. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  19. Total thyroidectomy with ultrasonic dissector for cancer: multicentric experience

    Directory of Open Access Journals (Sweden)

    Cirocchi Roberto

    2012-04-01

    Full Text Available Abstract Background We conducted an observational multicentric clinical study on a cohort of patients undergoing thyroidectomy for thyroid carcinoma. The aim of this study was to evaluate the benefits of the use of ultrasonic dissector (UAS vs. the use of a conventional technique (vessel clamp and tie in patients undergoing thyroid surgery for cancer. Methods From June 2009 to May 2010 we evaluated 321 consecutive patients electively admitted to undergo total thyroidectomy for thyroid carcinoma. The first 201 patients (89 males, 112 females presenting to our Department underwent thyroidectomy with the use of UAS while the following 120 patients (54 males, 66 females underwent thyroidectomy performed with a conventional technique (CT: vessel clamp and tie. Results The operative time (mean: 75 min in UAS vs. 113 min in CT, range: 54 to 120 min in UAS vs. 68 to 173 min in CT was much shorter in the group of thyroidectomies performed with UAS. The incidence of transient laryngeal nerve palsy (UAS 3/201 patients (1.49%; CT 1/120 patients (0.83% was higher in the group of UAS; the incidence of permanent laryngeal nerve palsy was similar in the two groups (UAS 2/201 patients (0.99% vs. CT 2/120 patients (1.66%. The incidence of transient hypocalcaemia (UAS 17/201 patients (8.4% vs. CT 9/120 patients (7.5% was higher in the UAS group; no relevant differences were reported in the incidence of permanent hypocalcaemia in the two groups (UAS 5/201 patients (2.48% vs. 2/120 patients (1.66%. Also the average postoperative length of stay was similar in two groups (2 days. Conclusion The only significant advantage proved by this study is represented by the cost-effectiveness (reduction of the usage of operating room for patients treated with UAS, secondary to the significant reduction of the operative time. The analysis failed to show any advantages in terms of postoperative transient complications in the group of patients treated with ultrasonic

  20. E-learning in radiology: An Italian multicentre experience

    International Nuclear Information System (INIS)

    Carriero, A.; Bonomo, L.; Calliada, F.; Campioni, P.; Colosimo, C.; Cotroneo, A.; Cova, M.; Ettorre, G.C.; Fugazzola, C.; Garlaschi, G.; Macarini, L.

    2012-01-01

    the band speed and technology of the Internet connection. Conclusions: Technological evolution is overcoming all barriers, and technology is also having a positive impact on the approach to teaching. Our multicentre teaching experience merits the following considerations: the quality of the teaching product was certified by the students’ judgements of its didactic content and the quality of reception; the economic cost of the teaching had a minimal impact on the post-graduate schools (€ 18 per lesson). In terms of breaking down national barriers, it is to be hoped that the coordination and integration of diagnostic imaging e-learning projects, with the participation of post-graduate schools in different European countries, can be developed not only in a spirit of “cultural sharing” and the exchange of teaching experiences.

  1. E-learning in radiology: An Italian multicentre experience

    Energy Technology Data Exchange (ETDEWEB)

    Carriero, A., E-mail: profcarriero@virgilio.it [Istituto di Radiologia Diagnostica ed Interventistica, AOU Maggiore della Carità, Corso Mazzini 18, 28100 Novara (Italy); Bonomo, L., E-mail: lbonomo@rm.unicatt.it [Istituto di Radiologia, Università Cattolica del S.Cuore, Largo Gemelli 8, 00168 Roma (Italy); Calliada, F., E-mail: f.calliada@smatteo.pv.it [Istituto di Radiologia c/o IRCCS Policlinico San Matteo Ospedale Generale Regionale, Piazzale Golgi 27100, Pavia (Italy); Campioni, P., E-mail: paolo.campioni@unife.it [Dipartimento di Scienze Chirurgiche, Radiologiche e Anestesiologiche, Sezione di Diagnostica per Immagini, Università di Ferrara Corso della Giovecca No. 203, 44100, Ferrara (Italy); Colosimo, C., E-mail: colosimo@rm.unicatt.it [Istituto di Radiologia, Università Cattolica del S.Cuore, Largo Gemelli 8, 00168 Roma (Italy); Cotroneo, A., E-mail: ar.cotroneo@rad.unich.it [Istituto di Radiologia, Università degli Studi Di Chieti (Italy); Cova, M., E-mail: cova@gnbts.univ.trieste.it [UCO di Radiologia, Ospedale di Cattinara, Strada di Fiume 447, 34149 Trieste (Italy); Ettorre, G.C., E-mail: g.ettorre@unict.it [Dip. Materno-Infantile e Scienze Radiologiche, Az. Ospedaliero-Universitaria Policlinico, Via S. Sofia 86, 95123 Catania (Italy); Fugazzola, C., E-mail: carlo.fugazzola@uninsubria.it [Dipartimento di Radiologia Ospedale Di Circolo, Viale Borri, No. 57, 21100, Varese (Italy); Garlaschi, G., E-mail: giacomog@unige.it [Dipartimento di Medicina interna e Specialità mediche (DIMI) Via L.B. Alberti, 4, 16132 Genova (Italy); Macarini, L., E-mail: l.macarini@unifg.it [Radiologia Universitaria Ospedali Riuniti di Foggia, Viale Pinto, No. 1, 71100, Foggia (Italy); and others

    2012-12-15

    the band speed and technology of the Internet connection. Conclusions: Technological evolution is overcoming all barriers, and technology is also having a positive impact on the approach to teaching. Our multicentre teaching experience merits the following considerations: the quality of the teaching product was certified by the students’ judgements of its didactic content and the quality of reception; the economic cost of the teaching had a minimal impact on the post-graduate schools (€ 18 per lesson). In terms of breaking down national barriers, it is to be hoped that the coordination and integration of diagnostic imaging e-learning projects, with the participation of post-graduate schools in different European countries, can be developed not only in a spirit of “cultural sharing” and the exchange of teaching experiences.

  2. A multicentre audit of HDR/PDR brachytherapy absolute dosimetry in association with the INTERLACE trial (NCT015662405)

    Science.gov (United States)

    Díez, P.; Aird, E. G. A.; Sander, T.; Gouldstone, C. A.; Sharpe, P. H. G.; Lee, C. D.; Lowe, G.; Thomas, R. A. S.; Simnor, T.; Bownes, P.; Bidmead, M.; Gandon, L.; Eaton, D.; Palmer, A. L.

    2017-12-01

    A UK multicentre audit to evaluate HDR and PDR brachytherapy has been performed using alanine absolute dosimetry. This is the first national UK audit performing an absolute dose measurement at a clinically relevant distance (20 mm) from the source. It was performed in both INTERLACE (a phase III multicentre trial in cervical cancer) and non-INTERLACE brachytherapy centres treating gynaecological tumours. Forty-seven UK centres (including the National Physical Laboratory) were visited. A simulated line source was generated within each centre’s treatment planning system and dwell times calculated to deliver 10 Gy at 20 mm from the midpoint of the central dwell (representative of Point A of the Manchester system). The line source was delivered in a water-equivalent plastic phantom (Barts Solid Water) encased in blocks of PMMA (polymethyl methacrylate) and charge measured with an ion chamber at 3 positions (120° apart, 20 mm from the source). Absorbed dose was then measured with alanine at the same positions and averaged to reduce source positional uncertainties. Charge was also measured at 50 mm from the source (representative of Point B of the Manchester system). Source types included 46 HDR and PDR 192Ir sources, (7 Flexisource, 24 mHDR-v2, 12 GammaMed HDR Plus, 2 GammaMed PDR Plus, 1 VS2000) and 1 HDR 60Co source, (Co0.A86). Alanine measurements when compared to the centres’ calculated dose showed a mean difference (±SD) of  +1.1% (±1.4%) at 20 mm. Differences were also observed between source types and dose calculation algorithm. Ion chamber measurements demonstrated significant discrepancies between the three holes mainly due to positional variation of the source within the catheter (0.4%-4.9% maximum difference between two holes). This comprehensive audit of absolute dose to water from a simulated line source showed all centres could deliver the prescribed dose to within 5% maximum difference between measurement and calculation.

  3. Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study

    Directory of Open Access Journals (Sweden)

    Grant Adrian M

    2006-12-01

    Full Text Available Abstract Background Securing and managing finances for multicentre randomised controlled trials is a highly complex activity which is rarely considered in the research literature. This paper describes the process of financial negotiation and the impact of financial considerations in four UK multicentre trials. These trials had met, or were on schedule to meet, recruitment targets agreed with their public-sector funders. The trials were considered within a larger study examining factors which might be associated with trial recruitment (STEPS. Methods In-depth semi-structured telephone interviews were conducted in 2003–04 with 45 individuals with various responsibilities to one of the four trials. Interviewees were recruited through purposive and then snowball sampling. Interview transcripts were analysed with the assistance of the qualitative package Atlas-ti. Results The data suggest that the UK system of dividing funds into research, treatment and NHS support costs brought the trial teams into complicated negotiations with multiple funders. The divisions were somewhat malleable and the funding system was used differently in each trial. The fact that all funders had the potential to influence and shape the trials considered here was an important issue as the perspectives of applicants and funders could diverge. The extent and range of industry involvement in non-industry-led trials was striking. Three broad periods of financial work (foundation, maintenance, and resourcing completion were identified. From development to completion of a trial, the trialists had to be resourceful and flexible, adapting to changing internal and external circumstances. In each period, trialists and collaborators could face changing costs and challenges. Each trial extended the recruitment period; three required funding extensions from MRC or HTA. Conclusion This study highlights complex financial aspects of planning and conducting trials, especially where multiple

  4. Chikungunya Infection in India: Results of a Prospective Hospital Based Multi-Centric Study

    OpenAIRE

    Ray, Pratima; Ratagiri, Vinod H.; Kabra, Sushil K.; Lodha, Rakesh; Sharma, Sumit; Sharma, B. S.; Kalaivani, Mani; Wig, Naveet

    2012-01-01

    BACKGROUND: Chikungunya (CHIKV) has recently seen a re-emergence in India with high morbidity. However, the epidemiology and disease burden remain largely undetermined. A prospective multi-centric study was conducted to evaluate clinical, epidemiological and virological features of chikugunya infection in patients with acute febrile illness from various geographical regions of India. METHODS AND FINDINGS: A total of 540 patients with fever of up to 7 days duration were enrolled at Karnataka I...

  5. How useful are high vaginal swabs in general practice? Results of a multicentre study.

    Science.gov (United States)

    Jungmann, E; Johnson, A M; Ridgway, G; Durrant, K; Robinson, A J

    2004-04-01

    Vulvovaginal symptoms are a common reason for consultation with a general practitioner (GP). High vaginal swabs (HVS) are used to investigate symptoms, but their usefulness is poorly evaluated and microbiological tests performed vary between laboratories. In this multicentre study of 797 women with genital symptoms attending GPs, diagnostic yield of HVS was poor except for Candida spp. (22%). There is an urgent need to establish the most cost-effective approach for the management of these women.

  6. Multicentric osteolysis with nodulosis and arthropathy (MONA) with cardiac malformation, mimicking polyarticular juvenile idiopathic arthritis

    DEFF Research Database (Denmark)

    Castberg, Filip Christian; Kjaergaard, Susanne; Mosig, Rebecca A

    2013-01-01

    The 'vanishing bone' syndrome multicentric osteolysis with nodulosis and arthropathy (MONA) is a rare chronic skeleton disorder caused by matrix metalloproteinase 2 (MMP2) deficiency, mimicking erosive polyarticular juvenile idiopathic arthritis. MONA is characterised by facial dysmorphism...... six also had congenital cardiac malformations. Despite treatment attempts of our patient with methotrexate, eternacept and prednisolone, serial X-ray studies documented continuous severe bone degeneration. Conclusion: The case documents the natural history of MONA and establishes a link between MMP2...

  7. Multicentre prospective cohort study of body mass index and postoperative complications following gastrointestinal surgery

    OpenAIRE

    Drake, T. M.; Nepogodiev, D.; Chapman, S. J.; Glasbey, J. C.; Khatri, C.; Kong, C. Y.; Claireaux, H. A.; Bath, M. F.; Mohan, M.; McNamee, L.; Kelly, M.; Mitchell, H.; Fitzgerald, J. E.; Harrison, E. M.; Bhangu, A.

    2016-01-01

    BackgroundThere is currently conflicting evidence surrounding the effects of obesity on postoperative outcomes. Previous studies have found obesity to be associated with adverse events, but others have found no association. The aim of this study was to determine whether increasing body mass index (BMI) is an independent risk factor for development of major postoperative complications.MethodsThis was a multicentre prospective cohort study across the UK and Republic of Ireland. Consecutive pati...

  8. Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial

    OpenAIRE

    Nauth, A. (Aaron); Creek, A.T. (Aaron T.); Zellar, A. (Abby); Lawendy, A.-R. (Abdel-Rahman); Dowrick, A. (Adam); Gupta, A. (Ajay); Dadi, A. (Akhil); Kampen, A.; Yee, A. (Albert); Vries, Alexander; de Mol van Otterloo, A. (Alexander); Garibaldi, A. (Alisha); Liew, A. (Allen); McIntyre, A.W. (Allison W.); Prasad, A.S. (Amal Shankar)

    2017-01-01

    textabstractBackground Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a...

  9. i-gel™ supraglottic airway in clinical practice: a prospective observational multicentre study

    OpenAIRE

    Theiler, L.; Gutzmann, M.; Kleine-Brueggeney, M.; Urwyler, N.; Kaempfen, B.; Greif, R.

    2017-01-01

    Background The i-gel™ supraglottic airway device has been studied in randomized controlled studies, but it has not been evaluated in a large prospective patient cohort. Therefore, we performed this prospective multicentre observational study to evaluate success rates, airway leak pressure, risk factors for i-gel failure, and adverse events. Methods With Ethics Committee approval and waiver of patients' consent, data about anaesthesia providers, patient characteristics, and the performance of ...

  10. A new Gauss quadrature for multicentre integrals over STOs in the Gaussian integral transform approach

    International Nuclear Information System (INIS)

    Bouferguene, Ahmed

    2005-01-01

    When computing multicentre integrals over Slater-type orbitals (STOs) by means of the Shavitt and Karplus Gaussian integral transforms (Shavitt and Karplus 1962 J. Chem. Phys. 36 550), one usually ends up with a multiple integral of the form ∫ 0 1 du ∫ 0 1 dv ...∫ 0 ∞ dz F(u, v, ..., z) (Shavitt and Karplus 1965 J. Chem. Phys. 43 398) in which all the integrals are inter-related. The most widely used approach for computing such an integral is to apply a product of Gauss-Legendre quadratures for the integrals over [0, 1] while the semi-infinite term is evaluated by a special procedure. Although numerous approaches have been developed to accurately perform the integration over [0, ∞) efficiently, it is the aim of this work to add a new tool that could be of some benefit in carrying out the hard task of multicentre integrals over STOs. The new approach relies on a special Gauss quadrature referred to as Gauss-Bessel to accurately evaluate the semi-infinite integral of interest. In this work, emphasis is put on accuracy rather than efficiency since its aim is essentially to bring a proof of concept showing that Gauss-Bessel quadrature can successfully be applied in the context of multicentre integrals over STOs. The obtained accuracy is comparable to that obtained with other methods available in the literature

  11. Methyl aminolevulinate photodynamic therapy for onychomycosis: a multicentre, randomized, controlled clinical trial.

    Science.gov (United States)

    Gilaberte, Y; Robres, M P; Frías, M P; García-Doval, I; Rezusta, A; Aspiroz, C

    2017-02-01

    Onychomycosis is a common fungal nail infection that responds poorly to antifungals. To investigate the efficacy and safety of methyl aminolevulinate (MAL) photodynamic therapy (PDT) in the treatment of onychomycosis. A multicentre (3), randomized, placebo-controlled clinical trial compared the effects of three sessions of urea (40%) plus conventional MAL-PDT with urea (40%) plus placebo (red light) photodynamic therapy (pPDT) in onychomycosis patients. Efficacy, both clinical (onychomycosis severity index, OSI) and microbiological, was blindly evaluated after 36 weeks of follow-up. Forty patients were analysed in the trial. Twenty-two received MAL-PDT and 18 pPDT. A complete response (OSI = 0) was observed for four patients (18.18%) in the MAL-PDT group and one (5.56%) in the pPDT group (NTT 7.92, 95% CI: 2.98-9.69, P = 0.23). A decrease in OSI score of over 75% (OSI75) was achieved by 40.91% of the patients in the MAL-PDT group and 16.67% in the pPDT group (P = 0.096). Microbiological cure was achieved by seven patients (31.82%) in the MAL-PDT group and two (11.11%) in the pPDT group (P = 0.178). MAL-PDT resulted in better rates of clinical response [OSI >75%: 53.85% vs. 18.75% (P =0.048)] and microbiological cure [41.56% vs. 7.14% (P = 0.037)] in non-dystrophic vs. dystrophic onychomycosis patients. No significant side-effects were reported. The limitations of the study were the reduced sample size and the unexpected efficacy of the control treatment, which was attributed to the 40% urea pre-treatment. This study did not show significant differences between urea 40% + MAL-PDT and urea 40% + pPDT in the treatment of onychomycosis. However, some results suggest that this treatment may constitute an alternative for dermatophyte and non-dermatophyte mould onychomycosis in patients not eligible for systemic treatment, particularly in the absence of total nail dystrophy. © 2016 European Academy of Dermatology and Venereology.

  12. [Thrombosis during thrombopoietin receptor agonist treatment for immune thrombocytopenia. A French multicentric observational study].

    Science.gov (United States)

    Weber, E; Moulis, G; Mahévas, M; Guy, C; Lioger, B; Durieu, I; Hunault, M; Ramanantsoa, M; Royer, B; Default, A; Pérault-Pochat, M-C; Moachon, L; Bernard, N; Bardy, G; Jonville-Bera, A-P; Geniaux, H; Godeau, B; Cathébras, P

    2017-03-01

    Thrombopoietin-receptor agonists (TPO-RA) are marketed for immune thrombocytopenia (ITP). They have been associated to thrombosis occurrence in randomized controlled trials. However, the characteristics of these thromboses in the real-life practice as well as their management are poorly known. The objectives of this study were to determine the risk factors, circumstances and management of thrombosis occurring during exposure to TPO-RA in ITP. We carried out a multicentre retrospective study in France. Moreover, all cases reported to the French pharmacovigilance system were also analyzed. Overall, 41 thrombosis (13 arterial) in 36 ITP patients (14 males and 22 females, mean age: 59 years) were recorded between January 2009 and October 2015. Twenty patients were treated with romiplostim, 15 with eltrombopag and 1 was treated by both medications. Thirty-three (92%) of the patients had another risk factor for thrombosis. Ten (28%) had an history of thrombosis and 13 (36%) received immunoglobulin in the month preceding the thrombotic event. Three had antiphospholipid antibodies; congenital low-risk thrombophilia was found in 4 cases; 18 patients (50%) were splenectomized. Median platelet count at the time of thrombosis was 172G/l (1-1049G/l). In 22 patients (56%), a good prognosis was associated with the thrombosis and was not linked with TPO-RA withdrawal. Bleeding events occurred in 14% of the patients treated with antiplatelet or anticoagulant drug, including 5% serious events (1 death of intracranial haemorrhage, 1 death of haemorrhagic shock). The thrombotic risk may be carefully assessed before starting TPO-RA in ITP patients. The impact of antiphospholipid antibodies and of congenital thrombophilia remains to be defined. Thrombosis evolution seems independent of TPO-RA management. Bleeding manifestations seem rare. Poor prognosis was mainly due to ischemic sequelae. Copyright © 2016 Société Nationale Française de Médecine Interne (SNFMI

  13. Prevalence and predictors of alcohol use during pregnancy: findings from international multicentre cohort studies.

    Science.gov (United States)

    O'Keeffe, Linda M; Kearney, Patricia M; McCarthy, Fergus P; Khashan, Ali S; Greene, Richard A; North, Robyn A; Poston, Lucilla; McCowan, Lesley M E; Baker, Philip N; Dekker, Gus A; Walker, James J; Taylor, Rennae; Kenny, Louise C

    2015-07-06

    To compare the prevalence and predictors of alcohol use in multiple cohorts. Cross-cohort comparison of retrospective and prospective studies. Population-based studies in Ireland, the UK, Australia and New Zealand. 17,244 women of predominantly Caucasian origin from two Irish retrospective studies (Growing up in Ireland (GUI) and Pregnancy Risk Assessment Monitoring System Ireland (PRAMS Ireland)), and one multicentre prospective international cohort, Screening for Pregnancy Endpoints (SCOPE) study. Prevalence of alcohol use pre-pregnancy and during pregnancy across cohorts. Sociodemographic factors associated with alcohol consumption in each cohort. Alcohol consumption during pregnancy in Ireland ranged from 20% in GUI to 80% in SCOPE, and from 40% to 80% in Australia, New Zealand and the UK. Levels of exposure also varied substantially among drinkers in each cohort ranging from 70% consuming more than 1-2 units/week in the first trimester in SCOPE Ireland, to 46% and 15% in the retrospective studies. Smoking during pregnancy was the most consistent predictor of gestational alcohol use in all three cohorts, and smokers were 17% more likely to drink during pregnancy in SCOPE, relative risk (RR)=1.17 (95% CI 1.12 to 1.22), 50% more likely to drink during pregnancy in GUI, RR=1.50 (95% CI 1.36 to 1.65), and 42% more likely to drink in PRAMS, RR=1.42 (95% CI 1.18 to 1.70). Our data suggest that alcohol use during pregnancy is prevalent and socially pervasive in the UK, Ireland, New Zealand and Australia. New policy and interventions are required to reduce alcohol prevalence both prior to and during pregnancy. Further research on biological markers and conventions for measuring alcohol use in pregnancy is required to improve the validity and reliability of prevalence estimates. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  14. The optimized acupuncture treatment for neck pain caused by cervical spondylosis: a study protocol of a multicentre randomized controlled trial

    Science.gov (United States)

    2012-01-01

    Background Neck pain is one of the chief symptoms of cervical spondylosis (CS). Acupuncture is a well-accepted and widely used complementary therapy for the management of neck pain caused by CS. In this paper, we present a randomized controlled trial protocol evaluating the use of acupuncture for CS neck pain, comparing the effects of the optimized acupuncture therapy in real practice compared with sham and shallow acupuncture. Methods/Design This trial uses a multicentre, parallel-group, randomized, sham acupuncture and shallow acupuncture, controlled single-blind design. Nine hospitals are involved as trial centres. 945 patients who meet inclusion criteria are randomly assigned to receive optimized acupuncture therapy, sham acupuncture or shallow acupuncture by a computerized central randomization system. The interventions past for 4 weeks with eight to ten treatments in total. The group allocations and interventions are concealed to patients and statisticians. The Northwick Park Neck Pain Questionnaire (NPQ) is used as the primary outcome measure, and the McGill Pain Questionnaire (MPQ) and The Short Form (36) Health Survey (SF-36) are applied as secondary outcome measures. The evaluation is performed at baseline, at the end of the intervention, and at the end of the first month and the third month during follow-up. The statistical analyses will include baseline data comparison and repeated measures of analysis of variance (ANOVA) for primary and secondary outcomes of group and time differences. Adverse events (AEs) will be reported if they occur. Discussion This trial is a multicentre randomized control trial (RCT) on the efficacy of acupuncture for CS neck pain and has a large sample size and central randomization in China. It will strictly follow the CONSORT statement and STRICTA extension guideline to report high-quality study results. By setting the control groups as sham and shallow acupuncture, this study attempts to reveal the effects of real acupuncture

  15. The optimized acupuncture treatment for neck pain caused by cervical spondylosis: a study protocol of a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Liang Zhao-Hui

    2012-07-01

    Full Text Available Abstract Background Neck pain is one of the chief symptoms of cervical spondylosis (CS. Acupuncture is a well-accepted and widely used complementary therapy for the management of neck pain caused by CS. In this paper, we present a randomized controlled trial protocol evaluating the use of acupuncture for CS neck pain, comparing the effects of the optimized acupuncture therapy in real practice compared with sham and shallow acupuncture. Methods/Design This trial uses a multicentre, parallel-group, randomized, sham acupuncture and shallow acupuncture, controlled single-blind design. Nine hospitals are involved as trial centres. 945 patients who meet inclusion criteria are randomly assigned to receive optimized acupuncture therapy, sham acupuncture or shallow acupuncture by a computerized central randomization system. The interventions past for 4 weeks with eight to ten treatments in total. The group allocations and interventions are concealed to patients and statisticians. The Northwick Park Neck Pain Questionnaire (NPQ is used as the primary outcome measure, and the McGill Pain Questionnaire (MPQ and The Short Form (36 Health Survey (SF-36 are applied as secondary outcome measures. The evaluation is performed at baseline, at the end of the intervention, and at the end of the first month and the third month during follow-up. The statistical analyses will include baseline data comparison and repeated measures of analysis of variance (ANOVA for primary and secondary outcomes of group and time differences. Adverse events (AEs will be reported if they occur. Discussion This trial is a multicentre randomized control trial (RCT on the efficacy of acupuncture for CS neck pain and has a large sample size and central randomization in China. It will strictly follow the CONSORT statement and STRICTA extension guideline to report high-quality study results. By setting the control groups as sham and shallow acupuncture, this study attempts to reveal the

  16. Building a Multi-centre Clinical Research Facilitation Network: The ARC Experience

    Directory of Open Access Journals (Sweden)

    Ian Nicholson

    2017-06-01

    Full Text Available Introduction: In order to practice evidence-based veterinary medicine, good quality clinical evidence needs to be produced, in order that it can be apprasied systematically by the EBVM network, and used by vets. There is very little good-quality veterinary evidence for most of the veterinary procedures carried out every day across the world. Very few, if any, individuals have all the necessary qualities (case-load, time, research expertise, financial support to be able to systematically produce good-quality, and relevant, clinical research on their own, in a timely manner. The Association for Veterinary Soft Tissue Surgery (AVSTS www.avsts.org.uk is an affiliate group with the British Small Animal Veterinary Association (BSAVA, and functions as a clinical network of like-minded individuals. In 2013 AVSTS sought to create a role for itself in facilitating the production (by its members of multi-centre clinical research of relevance to its members.Materials and methods: Members of AVSTS were asked to join the AVSTS Research Cooperative (ARC, with a veterinary epidemiologist and an experienced multi-centre veterinary clinical researcher (to help with study design and statistical planning, and the Animal Health Trust clinical research ethics committee. An email list was established, and a page was set up on the AVSTS website, to allow information to be disseminated. The AVSTS spring and autumn meetings were used as a regular forum by ARC, to discuss its direction, to generate interest, to create and promote specific studies (in order to widen participation amongst different centres, and to update members about previous studies.Results: Membership of ARC has grown to 224 people, although the epidemiologist left. One multi-centre study has been published, two have been presented and await publication, one has been accepted for presentation, two other studies are gathering data at present, and further studies are in the pipeline. There has been

  17. Changing prevalence patterns in endoscopic and histological diagnosis of gastritis? Data from a cross-sectional Central European multicentre study.

    Science.gov (United States)

    Wolf, Eva-Maria; Plieschnegger, Wolfgang; Geppert, Michael; Wigginghaus, Bernd; Höss, Gabriele M; Eherer, Andreas; Schneider, Nora I; Hauer, Almuthe; Rehak, Peter; Vieth, Michael; Langner, Cord

    2014-05-01

    Traditionally, Helicobacter infection is considered to be the most common cause of gastritis. In the cross-sectional Central European histoGERD trial, we assessed the prevalence of different types of gastritis, correlating histological and endoscopic diagnoses. A total of 1123 individuals participated in an observational multicentre study. Endoscopists classified individuals as positive or negative for gastritis and rendered the putative cause. Pathologists evaluated biopsy specimens based upon the Updated Sydney System. Histological diagnosis of gastritis was made in 639 (56.9%) participants. In all, 210 (18.7%) individuals were diagnosed with Helicobacter gastritis, 215 (19.1%) with post Helicobacter gastritis, 234 (20.8%) with reactive gastropathy, 26 (2.3%) with autoimmune gastritis, and 6 (0.5%) with focally enhanced gastritis related to Crohn's disease. In 46 out of 639 (7.2%) individuals diagnosed with gastritis, combinations of different histological subtypes were noted the most common being reactive gastropathy and post Helicobacter gastritis. Endoscopic diagnosis of gastritis was made in 534 (47.6%) individuals. Reactive gastropathy was more common than active Helicobacter gastritis, and the majority of cases attributable to Helicobacter infection were no longer ongoing, i.e. post Helicobacter gastritis. Agreement between histological and endoscopic diagnoses was better in reactive gastropathy than in Helicobacter gastritis. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  18. Preliminary Results of a Multicentre Study of the UBC Rapid Test for Detection of Urinary Bladder Cancer.

    Science.gov (United States)

    Ecke, Thorsten H; Arndt, Christian; Stephan, Carsten; Hallmann, Steffen; Lux, Oliver; Otto, Thomas; Ruttloff, Jürgen; Gerullis, Holger

    2015-05-01

    UBC Rapid is a test detecting fragments of cytokeratins 8 and 18 in urine. These are cytokeratins frequently overexpressed in tumor cells. We present the first results of a multi-centre study using UBC Rapid in patients with bladder cancer and healthy controls. Clinical urine samples from 92 patients with tumors of the urinary bladder (45 low-grade and 47 high-grade tumors) and from 33 healthy controls were used. Urine samples were analyzed by the UBC Rapid point-of-care (POC) system and evaluated both visually and quantitatively using a concile Omega 100 POC reader. For visual evaluation, different thresholds of band intensity for considering a test as positive were applied. Sensitivities and specificities were calculated by contingency analyses. We found that pathological concentrations by UBC Rapid are detectable in urine of patients with bladder cancer. The calculated diagnostic sensitivity of UBC Rapid in urine was 68.1% for high-grade, but only 46.2% for low-grade tumors. The specificity was 90.9%. The area under the curve (AUC) after receiver-operated curve (ROC) analysis was 0.733. Pathological levels of UBC Rapid in urine are higher in patients with bladder cancer in comparison to the control group (pbladder cancer and controls. Further studies with a greater number of patients will show how valuable these results are. Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

  19. Disease characteristics and management of hospitalised adolescents and adults with community-acquired pneumonia in China: a retrospective multicentre survey.

    Science.gov (United States)

    Chen, Liang; Zhou, Fei; Li, Hui; Xing, Xiqian; Han, Xiudi; Wang, Yiming; Zhang, Chunxiao; Suo, Lijun; Wang, Jingxiang; Yu, Guohua; Wang, Guangqiang; Yao, Xuexin; Yu, Hongxia; Wang, Lei; Liu, Meng; Xue, Chunxue; Liu, Bo; Zhu, Xiaoli; Li, Yanli; Xiao, Ying; Cui, Xiaojing; Li, Lijuan; Uyeki, Timothy M; Wang, Chen; Cao, Bin

    2018-02-15

    To describe the clinical characteristics and management of patients hospitalised with community-acquired pneumonia (CAP) in China. This was a multicentre, retrospective, observational study. 13 teaching hospitals in northern, central and southern China from 1 January 2014 to 31 December 2014 PARTICIPANTS: Information on hospitalised patients aged ≥14 years with radiographically confirmed pneumonia with illness onset in the community was collected using standard case report forms. Resource use for CAP management. Of 14 793 patients screened, 5828 with radiographically confirmed CAP were included in the final analysis. Low mortality risk patients with a CURB-65 score 0-1 and Pneumonia Severity Index risk class I-II accounted for 81.2% (4434/5594) and 56.4% (2034/3609) patients, respectively. 21.7% (1111/5130) patients had already achieved clinical stability on admission. A definite or probable pathogen was identified only in 12.7% (738/5828) patients. 40.9% (1575/3852) patients without pseudomonal infection risk factors received antimicrobial overtreatment regimens. The median duration between clinical stability to discharge was 5.0 days with 30-day mortality of 4.2%. These data demonstrated the overuse of health resources in CAP management, indicating that there is potential for improvement and substantial savings to healthcare systems in China. NCT02489578; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  20. Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug.

    Science.gov (United States)

    Tzikas, Apostolos; Shakir, Samera; Gafoor, Sameer; Omran, Heyder; Berti, Sergio; Santoro, Gennaro; Kefer, Joelle; Landmesser, Ulf; Nielsen-Kudsk, Jens Erik; Cruz-Gonzalez, Ignacio; Sievert, Horst; Tichelbäcker, Tobias; Kanagaratnam, Prapa; Nietlispach, Fabian; Aminian, Adel; Kasch, Friederike; Freixa, Xavier; Danna, Paolo; Rezzaghi, Marco; Vermeersch, Paul; Stock, Friederike; Stolcova, Miroslava; Costa, Marco; Ibrahim, Reda; Schillinger, Wolfgang; Meier, Bernhard; Park, Jai-Wun

    2016-02-01

    To investigate the safety, feasibility, and efficacy of left atrial appendage occlusion (LAAO) with the AMPLATZER Cardiac Plug (ACP) for stroke prevention in patients with atrial fibrillation (AF). Data from consecutive patients treated in 22 centres were collected. A total of 1,047 patients were included in the study. Procedural success was 97.3%. There were 52 (4.97%) periprocedural major adverse events. Follow-up was complete in 1,001/1,019 (98.2%) of successfully implanted patients (average 13 months, total 1,349 patient-years). One-year all-cause mortality was 4.2%. No death at follow-up was reported as device-related. There were nine strokes (0.9%) and nine transient ischaemic attacks (0.9%) during follow-up. The annual rate of systemic thromboembolism was 2.3% (31/1,349 patient-years), which is a 59% risk reduction. There were 15 major bleedings (1.5%) during follow-up. The annual rate of major bleeding was 2.1% (28/1,349 patient-years), which is a 61% risk reduction. Patients with single LAAO on aspirin monotherapy or no therapy and longer follow-up had fewer cerebral and fewer bleeding events. In this multicentre study, LAAO with the ACP showed high procedural success and a favourable outcome for the prevention of AF-related thromboembolism. Modification in antithrombotic therapy after LAAO may result in reduction of bleeding events.

  1. Treatment of multicentric or cranial mediastinal high-grade T-cell lymphoma in dogs with a first-line CCNU-L(-chlorambucil)-CHOP protocol

    NARCIS (Netherlands)

    Ossowska, M.; Teske, E.; Beirens-Van Kuijk, L.; Zandvliet, Maurice; De Vos, J. P.

    2016-01-01

    This retrospective study determined disease free survival (DFS) and progression free survival (PFS) in chemo-naïve dogs with multicentric or cranial mediastinal high-grade T-cell lymphoma, treated with a first-line CCNU-L(-chlorambucil)-CHOP protocol. Of thirteen dogs with multicentric lymphoma,

  2. Multicentre evaluation of the new ORTHO VISION® analyser.

    Science.gov (United States)

    Lazarova, E; Scott, Y; van den Bos, A; Wantzin, P; Atugonza, R; Solkar, S; Carpio, N

    2017-10-01

    Implementation of fully automated analysers has become a crucial security step in the blood bank; it reduces human errors, allows standardisation and improves turnaround time (TAT). We aimed at evaluating the ease of use and the efficiency of the ORTHO VISION ® Analyser (VISION) in comparison to the ORTHO AutoVue ® Innova System (AutoVue) in six different laboratories. After initial training and system configuration, VISION was used in parallel to AutoVue following the daily workload, both automates being based on ORTHO BioVue ® System column agglutination technology. Each participating laboratory provided data and scored the training, system configuration, quality control, maintenance and system efficiency. A total of 1049 individual samples were run: 266 forward and reverse grouping and antibody screens with 10 urgent samples, 473 ABD forward grouping and antibody screens with 22 urgent samples, 160 ABD forward grouping, 42 antibody screens and a series of 108 specific case profiles. The VISION instrument was more rapid than the AutoVue with a mean performing test time of 27·9 min compared to 36 min; for various test type comparisons, the TAT data obtained from VISION was shorter than that from AutoVue. Moreover, VISION analysed urgent STAT samples faster. Regarding the ease of use, VISION was intuitive and user friendly. VISION is a robust, reproducible system performing the most types of analytical determinations needed for pre-transfusion testing today, thus accommodating a wide range of clinical needs. VISION brings appreciated new features that could further secure blood transfusions. © 2017 The Authors. Transfusion Medicine published by John Wiley & Sons Ltd on behalf of British Blood Transfusion Society.

  3. HPV and cofactors for invasive cervical cancer in Morocco: a multicentre case-control study

    OpenAIRE

    Berraho, Mohamed; Amarti-Riffi, Afaf; El-Mzibri, Mohammed; Bezad, Rachid; Benjaafar, Noureddine; Benideer, Abdelatif; Matar, Noureddine; Qmichou, Zinab; Abda, Naima; Attaleb, Mohammed; Znati, Kaoutar; El Fatemi, Hind; Bendahhou, Karima; Obtel, Majdouline; Filali Adib, Abdelhai

    2017-01-01

    Background Limited national information is available in Morocco on the prevalence and distribution of HPV-sub-types of cervical cancer and the role of other risk factors. The aim was to determine the frequency of HPV-sub-types of cervical cancer in Morocco and investigate risk factors for this disease. Methods Between November 2009 and April 2012 a multicentre case-control study was carried out. A total of 144 cases of cervical cancer and 288 age-matched controls were included. Odds-ratios an...

  4. ECSPECT prospective multicentre registry for single-port laparoscopic colorectal procedures

    DEFF Research Database (Denmark)

    Weiss, Helmut; Zorron, R; Vestweber, K-H

    2017-01-01

    patients undergoing single-port colorectal surgery were enrolled from 11 European centres between March 2010 and March 2014. Data were analysed to assess patient-, technique- and procedure-dependent parameters. A validated sex-adjusted risk chart was developed for prediction of single-port colorectal......BACKGROUND: The international multicentre registry ECSPECT (European Consensus of Single Port Expertise in Colorectal Treatment) was established to evaluate the general feasibility and safety of single-port colorectal surgery with regard to preoperative risk assessment. METHODS: Consecutive...

  5. Non conventional psychiatric rehabilitation in schizophrenia using therapeutic riding: the FISE multicentre Pindar project

    Directory of Open Access Journals (Sweden)

    Stefania Cerino

    2011-12-01

    Full Text Available The FISE (Federazione Italiana Sport Equestri Pindar is a multicentre research project aimed at testing the potential effects of therapeutic riding on schizophrenic patients. Twenty-four subjects with a diagnosis of schizophrenia were enrolled for a 1 year-treatment involving therapeutic riding sessions. All subjects were tested at the beginning and at the end of treatment with a series of validated test batteries (BPRS and 8 items-PANSS. The results discussed in this paper point out an improvement in negative symptoms, a constant disease remission in both early onset and chronic disease subjects, as well as a reduced rate of hospitalization.

  6. Pregnancy, chimerism and lupus nephritis: a multi-centre study.

    NARCIS (Netherlands)

    Kremer Hovinga, I.C.; Koopmans, M.; Grootscholten, C.; Wal, A.M. van der; Bijl, M. van der; Derksen, R.H.W.M.; Voskuyl, A.E.; Heer, E. de; Bruijn, J.A.; Berden, J.H.M.; Bajema, I.M.

    2008-01-01

    Chimerism occurs twice as often in the kidneys of women with lupus nephritis as in normal kidneys and may be involved in the pathogenesis of systemic lupus erythematosus. Pregnancy is considered the most important source of chimerism, but the exact relationship between pregnancy, the persistence of

  7. Pregnancy, chimerism and lupus nephritis : a multi-centre study

    NARCIS (Netherlands)

    Hovinga, I. C. L. Kremer; Koopmans, M.; Grootscholten, C.; van der Wal, A. M.; Bijl, M.; Derksen, R. H. W. M.; Voslcuyl, A. E.; de Heer, E.; Bruijn, J. A.; Berden, J. H. M.; Rajema, I. M.

    2008-01-01

    Chimerism occurs twice as often in the kidneys of women with lupus nephritis as in normal kidneys and may he involved in the pathogenesis of systemic lupus erythematosus. Pregnancy is considered the most important source of chimerism, but the exact relationship between pregnancy, the persistence of

  8. Does osteoporosis increase complication risk in surgical fracture treatment? A protocol combining new endpoints for two prospective multicentre open cohort studies

    Directory of Open Access Journals (Sweden)

    Marent Marta

    2010-11-01

    Full Text Available Abstract Background With an ever-increasing elderly population, orthopaedic surgeons are faced with treating a high number of fragility fractures. Biomechanical tests have demonstrated the potential role of osteoporosis in the increased risk of fracture fixation complications, yet this has not been sufficiently proven in clinical practice. Based on this knowledge, two clinical studies were designed to investigate the influence of local bone quality on the occurrence of complications in elderly patients with distal radius and proximal humerus fractures treated by open reduction and internal fixation. Methods/Design The studies were planned using a prospective multicentre open cohort design and included patients between 50 and 90 years of age. Distal radius and proximal humerus fractures were treated with locking compression 2.4 mm and proximal humerus internal locking plates, respectively. Follow-up examinations were planned for 6 weeks, 3 and 12 months as well as a telephone interview at 6 months. The primary outcome focuses on the occurrence of at least one local bone quality related complication. Local bone quality is determined by measuring bone mineral density and bone mineral content at the contralateral radius. Primary complications are categorised according to predefined factors directly related to the bone/fracture or the implant/surgical technique. Secondary outcomes include the documentation of soft tissue/wound or general/systemic complications, clinical assessment of range of motion, and patient-rated evaluations of upper limb function and quality of life using both objective and subjective measures. Discussion The prospective multicentre open cohort studies will determine the value of local bone quality as measured by bone mineral density and content, and compare the quality of local bone of patients who experience a complication (cases following surgery with that of patients who do not (controls. These measurements are novel and

  9. Harmonization process and reliability assessment of anthropometric measurements in the elderly EXERNET multi-centre study.

    Science.gov (United States)

    Gómez-Cabello, Alba; Vicente-Rodríguez, Germán; Albers, Ulrike; Mata, Esmeralda; Rodriguez-Marroyo, Jose A; Olivares, Pedro R; Gusi, Narcis; Villa, Gerardo; Aznar, Susana; Gonzalez-Gross, Marcela; Casajús, Jose A; Ara, Ignacio

    2012-01-01

    The elderly EXERNET multi-centre study aims to collect normative anthropometric data for old functionally independent adults living in Spain. To describe the standardization process and reliability of the anthropometric measurements carried out in the pilot study and during the final workshop, examining both intra- and inter-rater errors for measurements. A total of 98 elderly from five different regions participated in the intra-rater error assessment, and 10 different seniors living in the city of Toledo (Spain) participated in the inter-rater assessment. We examined both intra- and inter-rater errors for heights and circumferences. For height, intra-rater technical errors of measurement (TEMs) were smaller than 0.25 cm. For circumferences and knee height, TEMs were smaller than 1 cm, except for waist circumference in the city of Cáceres. Reliability for heights and circumferences was greater than 98% in all cases. Inter-rater TEMs were 0.61 cm for height, 0.75 cm for knee-height and ranged between 2.70 and 3.09 cm for the circumferences measured. Inter-rater reliabilities for anthropometric measurements were always higher than 90%. The harmonization process, including the workshop and pilot study, guarantee the quality of the anthropometric measurements in the elderly EXERNET multi-centre study. High reliability and low TEM may be expected when assessing anthropometry in elderly population.

  10. MULTICENTRIC T-CELL LYMPHOMA AND CUTANEOUS HEMANGIOSARCOMA IN A CAPTIVE CHEETAH (ACINONYX JUBATUS).

    Science.gov (United States)

    Lindemann, Dana M; Carpenter, James W; Nietfeld, Jerome C; Gonzalez, Estehela; Hallman, Mackenzie; Hause, Ben M

    2015-12-01

    A 13-yr-old intact male cheetah (Acinonyx jubatus) presented for evaluation after a 4-mo history of intermittent lethargy and increased expiratory effort. The clinical signs were initially noted after the diagnosis and death of its 13-yr-old male sibling with solitary hepatic T-cell lymphoma. Physical examination findings included thin body condition, harsh lung sounds, peripheral lymphadenopathy, and a cutaneous mass on the right medial tarsus and scrotum. Excisional biopsies diagnosed well-differentiated cutaneous hemangiosarcomas. Thoracic radiographs revealed a cranial mediastinal mass. Complete blood count and serum biochemical analyses showed a leukocytosis with persistent lymphocytosis, progressive azotemia, and markedly elevated alkaline phosphatase. Because of the cheetah's declining quality of life, euthanasia was elected. Postmortem examination, histopathology, and immunohistochemical staining revealed multicentric T-cell lymphoma. Feline leukemia virus (FeLV) enzyme-linked immunosorbent assay, FeLV polymerase chain reaction (whole blood), and viral metagenomic analysis were negative. This is the first case of cutaneous hemangiosarcoma and multicentric T-cell lymphoma reported in a FeLV-negative cheetah.

  11. Harmonization Process and Reliability Assessment of Anthropometric Measurements in the Elderly EXERNET Multi-Centre Study

    Science.gov (United States)

    Gómez-Cabello, Alba; Vicente-Rodríguez, Germán; Albers, Ulrike; Mata, Esmeralda; Rodriguez-Marroyo, Jose A.; Olivares, Pedro R.; Gusi, Narcis; Villa, Gerardo; Aznar, Susana; Gonzalez-Gross, Marcela; Casajús, Jose A.; Ara, Ignacio

    2012-01-01

    Background The elderly EXERNET multi-centre study aims to collect normative anthropometric data for old functionally independent adults living in Spain. Purpose To describe the standardization process and reliability of the anthropometric measurements carried out in the pilot study and during the final workshop, examining both intra- and inter-rater errors for measurements. Materials and Methods A total of 98 elderly from five different regions participated in the intra-rater error assessment, and 10 different seniors living in the city of Toledo (Spain) participated in the inter-rater assessment. We examined both intra- and inter-rater errors for heights and circumferences. Results For height, intra-rater technical errors of measurement (TEMs) were smaller than 0.25 cm. For circumferences and knee height, TEMs were smaller than 1 cm, except for waist circumference in the city of Cáceres. Reliability for heights and circumferences was greater than 98% in all cases. Inter-rater TEMs were 0.61 cm for height, 0.75 cm for knee-height and ranged between 2.70 and 3.09 cm for the circumferences measured. Inter-rater reliabilities for anthropometric measurements were always higher than 90%. Conclusion The harmonization process, including the workshop and pilot study, guarantee the quality of the anthropometric measurements in the elderly EXERNET multi-centre study. High reliability and low TEM may be expected when assessing anthropometry in elderly population. PMID:22860013

  12. Comprehensive protocol of traceability during IVF: the result of a multicentre failure mode and effect analysis.

    Science.gov (United States)

    Rienzi, L; Bariani, F; Dalla Zorza, M; Albani, E; Benini, F; Chamayou, S; Minasi, M G; Parmegiani, L; Restelli, L; Vizziello, G; Costa, A Nanni

    2017-08-01

    Can traceability of gametes and embryos be ensured during IVF? The use of a simple and comprehensive traceability system that includes the most susceptible phases during the IVF process minimizes the risk of mismatches. Mismatches in IVF are very rare but unfortunately possible with dramatic consequences for both patients and health care professionals. Traceability is thus a fundamental aspect of the treatment. A clear process of patient and cell identification involving witnessing protocols has to be in place in every unit. To identify potential failures in the traceability process and to develop strategies to mitigate the risk of mismatches, previously failure mode and effects analysis (FMEA) has been used effectively. The FMEA approach is however a subjective analysis, strictly related to specific protocols and thus the results are not always widely applicable. To reduce subjectivity and to obtain a widespread comprehensive protocol of traceability, a multicentre centrally coordinated FMEA was performed. Seven representative Italian centres (three public and four private) were selected. The study had a duration of 21 months (from April 2015 to December 2016) and was centrally coordinated by a team of experts: a risk analysis specialist, an expert embryologist and a specialist in human factor. Principal investigators of each centre were first instructed about proactive risk assessment and FMEA methodology. A multidisciplinary team to perform the FMEA analysis was then formed in each centre. After mapping the traceability process, each team identified the possible causes of mistakes in their protocol. A risk priority number (RPN) for each identified potential failure mode was calculated. The results of the FMEA analyses were centrally investigated and consistent corrective measures suggested. The teams performed new FMEA analyses after the recommended implementations. In each centre, this study involved: the laboratory director, the Quality Control & Quality

  13. Job stress, absenteeism and coronary heart disease European cooperative study (the JACE study): Design of a multicentre prospective study

    NARCIS (Netherlands)

    Houtman, I.; Kornitzer, M.; Smet, P. de; Koyuncu, R.; Backer, G. de; Pelfrene, E.; Romon, M.; Boulenguez, C.; Ferrario, M.; Origgi, G.; Sans, S.; Perez, I.; Wilhelmsen, L.; Rosengren, A.; Isacsson, S.-O.; Östergren, P.-O.

    1999-01-01

    Background: The motives, objectives and design of a multicentre prospective study on job stress, absenteeism and coronary heart disease in Europe (the JACE study) is presented in this paper. Some specific gaps in the reviewed literature are explicitly tapped into by the JACE study. Its objectives

  14. A multicentre study to improve clinical interpretation of proteinase-3 and myeloperoxidase anti-neutrophil cytoplasmic antibodies

    DEFF Research Database (Denmark)

    Bossuyt, Xavier; Rasmussen, Niels; van Paassen, Pieter

    2017-01-01

    Objective: The objective of this multicentre study was to improve the clinical interpretation of PR3- and MPO-ANCAs as an adjunct for the diagnosis of ANCA-associated vasculitis (AAV) by defining thresholds and test result intervals based on predefined specificities and by calculating test result...

  15. Complete en bloc urinary exenteration for synchronous multicentric transitional cell carcinoma with sarcomatoid features in a hemodialysis patient

    Directory of Open Access Journals (Sweden)

    Tiberio M. Siqueira Jr

    2006-10-01

    Full Text Available The incidence of transitional cell carcinoma (TCC in patients submitted to hemodialysis is low. The presence of TCC with sarcomatoid features in this cohort is even scarcer. Herein, we describe a very rare case of synchronous multicentric muscle invasive bladder carcinoma with prostate invasion in a hemodialysis patient, submitted to complete en bloc urinary exenteration.

  16. Knowledge of pain management in patients with painful bone metastases : A multicentre randomized trial on pain education

    NARCIS (Netherlands)

    Geerling, J. I.; Reyners, A.; van der Linden, Y.; Mul, V.; Westhoff, P.; de Graeff, A.; Rodenhuis, C.; de Nijs, E.; Muilenburg, T.

    2016-01-01

    Background: Education of patients regarding pain management may improve patient empowerment and, consequently, reduce pain intensity. To investigate the effect of education on pain intensity, a multicentre phase 3 study was conducted between 1-3-2011 and 1-4-2016. A total of 354 patients who

  17. Synchronous multicentric small hepatocellular carcinomas: Defining the capsule on high-frequency intraoperative ultrasonography with pathologic correction

    Energy Technology Data Exchange (ETDEWEB)

    Ahn, Jae Hong; Eom, Dae Woon; Ryu, Dae Shick; Park, Man Soo; Jung, Seung Mun; Choi, Kun Moo; Cheon, Gab Jin; Choi, Soo Jung; Jang, Hyuk Jai [Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung (Korea, Republic of)

    2016-08-15

    The aim of this study was to define the capsules of synchronous multicentric small hepatocellular carcinomas (HCCs) with use of high-frequency intraoperative ultrasonography (IOUS). Among the 131 consecutive patients undergoing hepatic resection and high-frequency IOUS for HCC, 16 synchronous multicentric small HCCs in 13 patients were histologically diagnosed in the resected specimens. High-frequency IOUS and pathologic findings of these lesions were compared, with particular focus on the presence and appearance of the capsule in or around each lesion. Synchronous multicentric small HCCs were pathologically classified into distinctly nodular (n=12) or vaguely nodular (n=4) types. All 12 distinctly nodular HCCs including six subcentimeter lesions showed detectable capsules on high-frequency IOUS and pathology. The capsules appeared as a hypoechoic rim containing hyperechoic foci (n=6), hypoechoic rim (n=5), or hyperechoic rim (n=1) with varying degrees of coverage around each lesion. Histologically, the capsules were composed of a combination of one to four layers consisting of a fibrous capsule, peritumoral fibrosis, prominent small vessels, and entrapped hepatic parenchyma. Synchronous multicentric small HCCs with distinctly nodular type, even at subcentimeter size, can show capsules with varying coverage and diverse echogenicity on high-frequency IOUS.

  18. Postoperative radiotherapy of uterine sarcoma: A multicentric retrospective study

    International Nuclear Information System (INIS)

    Champetier, C.; Cowen, D.; Hannoun-Levi, J.M.; Resbeut, M.; Azria, D.; Salem, N.; Tessier, E.; Ellis, S.

    2011-01-01

    Purpose. - Surgery is the treatment of choice for localized uterine sarcomas. We conducted a retrospective study to define prognostic factors. Patients and methods. - We studied 111 cases of patients treated by adjuvant radiotherapy for uterine sarcoma in seven French centers. The median decline was 31 months. We conducted a univariate analysis to identify factors correlated with local recurrence. The statistically significant factors were studied in multivariate analysis by Cox model. Results. - The median dose of external beam radiotherapy was 45 Gy. Forty-three percent of patients had vaginal vault brachytherapy and 21 % chemotherapy. Only 6.3 % of patients had complications of acute grade III and 8.1 % of long-term sequelae of radiotherapy. The survival rate at 5 years was 74.6 %. They noted 12.6 % of isolated locoregional recurrences, against 29.7 % for distant recurrences, 80 % were pulmonary. Factors correlated with the risk of locoregional relapse were menopausal status (P = 0.045) and surgical margins suspicious or not healthy (P = 0.0095). The chemotherapy did not improve overall survival or disease free survival but the numbers were low. Conclusion. - The postoperative radiotherapy provides good local control in this disease. Brachytherapy is sometimes done, but it does not improve local control. Chemotherapy is not a standard localized stage but the rate of metastatic recurrence calls for the development of strategies involving systemic treatment with radiotherapy. (authors)

  19. [Medication errors in pediatric inpatients: a multicentric prospective study].

    Science.gov (United States)

    Stheneur, C; Armengaud, J-B; Castro, C; Chéron, G; Chevallier, B

    2006-10-01

    To improve the knowledge of medication errors in paediatrics: rate of occurrence, error characteristics, risk factors. Our prospective study included nine uninformed teaching paediatric wards (general paediatrics, emergency departments, intensive care units) using a describing questionnaire built from medical reports analysis (event description, medical issues, contributing personal and structural factors) during a two-months period. Seventy-five questionnaires were collected and analysed. Medical errors reported concerned prescription: 21 cases and administration: 45 cases. Ten errors led to adverse effects. An attributable factor was noted in 39 cases. Concerning prescription errors, no respect to protocol: 11 cases, lack of knowledge: 3 cases, personal communication failure: 3 cases were noted. Concerning administration errors, human mistakes (lack of experience, miscommunication, calculation error): 8 cases, unclear prescription: 6 cases and system flaws: 6 cases were noted. Several attribuable causes were reported in 8 cases. Medication errors in paediatrics inpatients are common and contributing factors intricated. Paediatricians should help hospitals develop effective programs for safety providing medications, reporting medication errors, errors analysis strategy and creating a safe environment of medication for all hospitalised paediatric patients.

  20. [Multicentre study of infection incidence in knee prosthesis].

    Science.gov (United States)

    Jaén, F; Sanz-Gallardo, M I; Arrazola, M P; García de Codes, A; de Juanes, A; Resines, C

    2012-01-01

    To determine the incidence of surgical site infection in knee prosthesis surgical procedure for a follow-up period of one year in twelve hospitals in Madrid region. A prospective study was carried out from January to December 2009 using a national surveillance system called Indicadores Clínicos de Mejora Continua de Calidad. Primary and revision knee joint replacements in patients operated on in the previous year were included. Criteria used to define surgical site infection and patient risk index categories were those established by the Centers for Disease Control and Prevention and National Nosocomial Infections Surveillance. The incidence rates were worked out crude and adjusted by hazard ratio. 2,088 knee prosthesis procedures were analyzed. The overall incidence of surgical site infection was 2.1%. Sixty-five percent of the infections were organ/space. Sixty percent of the infections were identified in the early postoperative period. Of all surgical site infections, 41.9% were microbiologically confirmed. Antibiotic prophylaxis was implemented correctly in 63.3% of the cases. The most important cause of inappropriate prophylaxis was an unsuitable duration in 85.7% of the cases. The presurgical preparation was carried out correctly in 50.3% of surgical operations. The incidence of knee arthroplasty infection was twice as high as in the National Healthcare Safety Network and similar to national rates. In this study, the incidence of infection was within the range of infection rates in other published European studies. Surveillance and control strategies of health care for associated infections allow us to assess trends and the impact of preventive measures. Copyright © 2011 SECOT. Published by Elsevier Espana. All rights reserved.

  1. A clinical prediction rule for meniscal tears in primary care: development and internal validation using a multicentre study.

    Science.gov (United States)

    Snoeker, Barbara Am; Zwinderman, Aeilko H; Lucas, Cees; Lindeboom, Robert

    2015-08-01

    In primary care, meniscal tears are difficult to detect. A quick and easy clinical prediction rule based on patient history and a single meniscal test may help physicians to identify high-risk patients for referral for magnetic resonance imaging (MRI). The study objective was to develop and internally validate a clinical prediction rule (CPR) for the detection of meniscal tears in primary care. In a cross-sectional multicentre study, 121 participants from primary care were included if they were aged 18-65 years with knee complaints that existed for meniscal tear. One diagnostic physical meniscal test and 14 clinical variables were considered to be predictors of MRI outcome. Using known predictors for the presence of meniscal tears, a 'quick and easy' CPR was derived. The final CPR included the variables sex, age, weight-bearing during trauma, performing sports, effusion, warmth, discolouration, and Deep Squat test. The final model had an AUC of 0.76 (95% CI = 0.72 to 0.80). A cut-point of 150 points yielded an overall sensitivity of 86.1% and a specificity of 45.5%. For this cut-point, the positive predictive value was 55.0%, and the negative predictive value was 81.1%. A scoring system was provided including the corresponding predicted probabilities for a meniscal tear. The CPR improved the detection of meniscal tears in primary care. Further evaluation of the CPR in new primary care patients is needed, however, to assess its usefulness. © British Journal of General Practice 2015.

  2. Iron-chelating therapy with deferasirox in transfusion-dependent, higher risk myelodysplastic syndromes: a retrospective, multicentre study.

    Science.gov (United States)

    Musto, Pellegrino; Maurillo, Luca; Simeon, Vittorio; Poloni, Antonella; Finelli, Carlo; Balleari, Enrico; Ricco, Alessandra; Rivellini, Flavia; Cortelezzi, Agostino; Tarantini, Giuseppe; Villani, Oreste; Mansueto, Giovanna; Milella, Maria R; Scapicchio, Daniele; Marziano, Gioacchino; Breccia, Massimo; Niscola, Pasquale; Sanna, Alessandro; Clissa, Cristina; Voso, Maria T; Fenu, Susanna; Venditti, Adriano; Santini, Valeria; Angelucci, Emanuele; Levis, Alessandro

    2017-06-01

    Iron chelation is controversial in higher risk myelodysplastic syndromes (HR-MDS), outside the allogeneic transplant setting. We conducted a retrospective, multicentre study in 51 patients with transfusion-dependent, intermediate-to-very high risk MDS, according to the revised international prognostic scoring system, treated with the oral iron chelating agent deferasirox (DFX). Thirty-six patients (71%) received azacitidine concomitantly. DFX was given at a median dose of 1000 mg/day (range 375-2500 mg) for a median of 11 months (range 0·4-75). Eight patients (16%) showed grade 2-3 toxicities (renal or gastrointestinal), 4 of whom (8%) required drug interruption. Median ferritin levels decreased from 1709 μg/l at baseline to 1100 μg/l after 12 months of treatment (P = 0·02). Seventeen patients showed abnormal transaminase levels at baseline, which improved or normalized under DFX treatment in eight cases. One patient showed a remarkable haematological improvement. At a median follow up of 35·3 months, median overall survival was 37·5 months. The results of this first survey of DFX in HR-MDS are comparable, in terms of safety and efficacy, with those observed in lower-risk MDS. Though larger, prospective studies are required to demonstrate real clinical benefits, our data suggest that DFX is feasible and might be considered in a selected cohort of HR-MDS patients. © 2017 John Wiley & Sons Ltd.

  3. Potential misdiagnosis of dysfibrinogenaemia: Data from multicentre studies amongst UK NEQAS and PRO-RBDD project laboratories.

    Science.gov (United States)

    Jennings, I; Kitchen, S; Menegatti, M; Palla, R; Walker, I; Peyvandi, F; Makris, M

    2017-12-01

    Mutations in fibrinogen (Fgn) genes, causing dysfibrinogenaemia, can result in either a bleeding or thrombophilic diathesis. Dysfibrinogenaemia is infrequently encountered in hospital laboratories, and the utility of different assays in the diagnosis of dysfibrinogenaemia has not previously been explored in a multicentre study. We describe here an exercise in which PRO-RBDD project (prospective data collection on patients with fibrinogen and Factor XIII deficiencies) centres, and UK NEQAS centres, performed investigations for dysfibrinogenaemia. Samples from donors with dysfibrinogenaemia (sample 1: gamma p.Arg301Cys, sample 2: Bbeta166Arg3Cys-Fgn Longmont, sample 3: Aalpha p.Arg35His) and a normal donor were sent to laboratories for investigation for possible dysfibrinogenaemia. Median, coefficient of variation and range were determined for each assay method. Results were returned from 62 UK NEQAS and 24 PRO-RBDD centres. PT, APTT, Clauss fibrinogen and thrombin times were performed by >90% of centres, with 51% performing reptilase times, and 31% fibrinogen antigen. All centres identified samples 1 and 3 as abnormal. However, 39% of centres reported a normal or raised fibrinogen for the Fgn Longmont sample, and marked differences in Clauss fibrinogen results with different reagents were noted for this sample (median 1.01 g/L vs 5.10 g/L for the two mostly widely used reagents). In-house studies suggest that the method of detection of fibrin clot formation may result in different Clauss fibrinogen measurements with FgnLongmont plasma. It is possible that some widely used methodologies, both using optical and mechanical end-point detection systems, will fail to detect this rare fibrinogen variant. © 2017 John Wiley & Sons Ltd.

  4. The impact of injuries study. multicentre study assessing physical, psychological, social and occupational functioning post injury - a protocol

    Directory of Open Access Journals (Sweden)

    Kendrick Denise

    2011-12-01

    Full Text Available Abstract Background Large numbers of people are killed or severely injured following injuries each year and these injuries place a large burden on health care resources. The majority of the severely injured are not fully recovered 12-18 months later. Psychological disorders are common post injury and are associated with poorer functional and occupational outcomes. Much of this evidence comes from countries other than the UK, with differing health care and compensation systems. Early interventions can be effective in treating psychological morbidity, hence the scale and nature of the problem and its impact of functioning in the UK must be known before services can be designed to identify and manage psychological morbidity post injury. Methods/Design A longitudinal multi-centre study of 680 injured patients admitted to hospital in four areas across the UK: Nottingham, Leicester/Loughborough, Bristol and Surrey. A stratified sample of injuries will ensure a range of common and less common injuries will be included. Participants will complete a baseline questionnaire about their injury and pre-injury quality of life, and follow-up questionnaires 1, 2, 4, and 12 months post injury. Measures will include health and social care utilisation, perceptions of recovery, physical, psychological, social and occupational functioning and health-related quality of life. A nested qualitative study will explore the experiences of a sample of participants, their carers and service providers to inform service design. Discussion This study will quantify physical, psychological, social and occupational functioning and health and social care utilisation following a range of different types of injury and will assess the impact of psychological disorders on function and health service use. The findings will be used to guide the development of interventions to maximise recovery post injury.

  5. [Sentinel node biopsy in patients with multifocal and multicentric breast cancer: A 5-year follow-up].

    Science.gov (United States)

    Blanco Saiz, I; López Carballo, M T; Martínez Fernández, J; Carrión Maldonado, J; Cabrera Pereira, A; Moral Alvarez, S; Santamaría Girón, L; Cantero Cerquella, F; López Secades, A; Díaz González, D; Llaneza Folgueras, A; Aira Delgado, F J

    2014-01-01

    Sentinel lymph node biopsy (SLNB) as a staging procedure in multiple breast cancer is a controversial issue. We have aimed to evaluate the efficacy of sentinel node (SN) detection in patients with multifocal or multicentric breast cancer as well as the safety of its clinical application after a long follow-up. A prospective descriptive study was performed. Eighty-nine patients diagnosed of multiple breast cancer (73 multifocal; 16 multicentric) underwent SLNB. These patients were compared to those with unifocal neoplasia. Periareolar radiocolloid administration was performed in most of the patients. Evaluation was made at an average of 67.2 months of follow-up (32-126 months). Scintigraphic and surgical SN localization in patients with multiple breast cancer were 95.5% and 92.1%, respectively. A higher percentage of extra-axillary nodes was observed than in the unifocal group (11.7% vs 5.4%) as well as a significantly higher number of SN per patient (1.70 vs 1.38). The rate of SN localization in multicentric cancer was slightly lower than in multifocal cancer (87.5% vs 93.1%), and the finding of extra-axillary drainages was higher (20% vs 10%). Number of SN per patient was significantly higher in multicentric breast cancer (2.33 vs 1.57). No axillary relapses have been demonstrated in the follow-up in multiple breast cancer patients group. SLNB performed by periareolar injection is a reliable and accurate staging procedure of patients with multiple breast cancer, including those with multicentric processes. Copyright © 2013 Elsevier España, S.L. and SEMNIM. All rights reserved.

  6. Sistema automatizado de hemocultivos Bact-Alert: 5 vs 7 días de incubación: Primer estudio multicéntrico argentino Bact-Alert automatized system for blood cultures: 5 vs 7 days of incubation: First Argentine multicentre study

    Directory of Open Access Journals (Sweden)

    R. Soloaga

    2004-03-01

    cultures by the Bact-Alert system (14,960 FAN aerobics, 3,855 FAN anaerobic, 11,114 standards aerobics, 11,367 standards anaerobic, 12,054 pediatrics and 26,791 FAN pediatrics bottles and 44.235 series from 27.615 patients at eight hospitals of Buenos Aires city, one of La Plata city and three of the Buenos Aires province. A total of 13,657 blood cultures yielded a positive result. Only 181 of them had been detected as positive between the 5th and 7th day of incubation and only 26 (0.19% had clinical significance (Staphylococcus aureus 3; coagulase negative staphylococci 2; Enterococcus faecalis 1; Streptococcus pneumoniae 2; Campylobacter spp 1; Escherichia coli 1; Enterobacter cloacae 1; Enterobacter aerogenes 1; Citrobacter freundii 1; Klebsiella pneumoniae 1; Proteus mirabilis 1; Serratia marcescens 4; yeasts 7, including one strain of Cryptococcus neoformans. Of the total of contaminants, 38% were isolated by the anaerobic standard (65% were Propionibacterium spp and 29% coagulase negative staphylococci, 31.2% by the FAN aerobic (33.3% difphteroids and 28.9% Bacillus spp, 11.8% by the pediatric, 9% by FAN pediatric, 8.33% by aerobic standard and 1.4% by FAN anaerobic bottle. Our results show that the prolonged incubation of blood cultures for more than 5 days using the Bact-Alert system is unnecessary.

  7. Quantification of FDG PET studies using standardised uptake values in multi-centre trials: effects of image reconstruction, resolution and ROI definition parameters

    NARCIS (Netherlands)

    Westerterp, Marinke; Pruim, Jan; Oyen, Wim; Hoekstra, Otto; Paans, Anne; Visser, Eric; van Lanschot, Jan; Sloof, Gerrit; Boellaard, Ronald

    2007-01-01

    PURPOSE: Standardised uptake values (SUVs) depend on acquisition, reconstruction and region of interest (ROI) parameters. SUV quantification in multi-centre trials therefore requires standardisation of acquisition and analysis protocols. However, standardisation is difficult owing to the use of

  8. Quantification of FDG PET studies using standardised uptake values in multi-centre trials : effects of image reconstruction, resolution and ROI definition parameters

    NARCIS (Netherlands)

    Westerterp, Marinke; Pruim, Jan; Oyen, Wim; Hoekstra, Otto; Paans, Anne; Visser, Eric; van Lanschot, Jan; Sloof, Gerrit; Boellaard, Ronald

    Purpose: Standardised uptake values (SUVs) depend on acquisition, reconstruction and region of interest (ROI) parameters. SUV quantification in multicentre trials therefore requires standardisation of acquisition and analysis protocols. However, standardisation is difficult owing to the use of

  9. Quantification of FDG PET studies using standardised uptake values in multi-centre trials: effects of image reconstruction, resolution and ROI definition parameters.

    NARCIS (Netherlands)

    Westerterp, M.; Pruim, J.; Oyen, W.J.G.; Hoekstra, O.; Paans, A.; Visser, E.P.; Lanschot, J.J. van; Sloof, G.; Boellaard, R.

    2007-01-01

    PURPOSE: Standardised uptake values (SUVs) depend on acquisition, reconstruction and region of interest (ROI) parameters. SUV quantification in multi-centre trials therefore requires standardisation of acquisition and analysis protocols. However, standardisation is difficult owing to the use of

  10. Home versus outpatient ultraviolet B phototherapy for mild to severe psoriasis : pragmatic multicentre randomised controlled non-inferiority trial (PLUTO study)

    NARCIS (Netherlands)

    Koek, Mayke B. G.; Buskens, Erik; van Weelden, Huib; Steegmans, Paul H. A.; Bruijnzeel-Koomen, Carla A. F. M.; Sigurdsson, Vigfus

    2009-01-01

    Objective To determine whether ultraviolet B phototherapy at home is equally safe and equally effective as ultraviolet B phototherapy in an outpatient setting for patients with psoriasis. Design Pragmatic multicentre single blind randomised clinical trial (PLUTO study). Setting Dermatology

  11. Sacrospinous hysteropexy versus vaginal hysterectomy with suspension of the uterosacral ligaments in women with uterine prolapse stage 2 or higher: multicentre randomised non-inferiority trial

    NARCIS (Netherlands)

    Detollenaere, R.J.; Boon, J. den; Stekelenburg, J.; Hout, J. in't; Vierhout, M.E.; Kluivers, K.B.; Eijndhoven, H.W. van

    2015-01-01

    OBJECTIVE: To investigate whether uterus preserving vaginal sacrospinous hysteropexy is non-inferior to vaginal hysterectomy with suspension of the uterosacral ligaments in the surgical treatment of uterine prolapse. DESIGN: Multicentre randomised controlled non-blinded non-inferiority trial.

  12. The feasibility of wireless capsule endoscopy in detecting small intestinal pathology in children under the age of 8 years: a multicentre European study

    NARCIS (Netherlands)

    Fritscher-Ravens, A.; Scherbakov, P.; Bufler, P.; Torroni, F.; Ruuska, T.; Nuutinen, H.; Thomson, M.; Tabbers, M.; Milla, P.

    2009-01-01

    Objective: To systematically evaluate the feasibility and methodology to carry out wireless capsule endoscopy (WCE) in children,8 years to define small intestinal pathology. Design: Prospective European multicentre study with negative prior investigation. Patients and interventions: 83 children aged

  13. Development and validation of PRE-DELIRIC (PREdiction of DELIRium in ICu patients) delirium prediction model for intensive care patients: observational multicentre study.

    NARCIS (Netherlands)

    Boogaard, M.W. van den; Pickkers, P.; Slooter, A.J.; Kuiper, M.A.; Spronk, P.E.; Voort, P.H. van der; Hoeven, J.G. van der; Donders, R.; Achterberg, T. van; Schoonhoven, L.

    2012-01-01

    OBJECTIVES: To develop and validate a delirium prediction model for adult intensive care patients and determine its additional value compared with prediction by caregivers. DESIGN: Observational multicentre study. SETTING: Five intensive care units in the Netherlands (two university hospitals and

  14. Simulation-based team training for multi-professional obstetric care teams to improve patient outcome : a multicentre, cluster randomised controlled trial

    NARCIS (Netherlands)

    Fransen, A F; van de Ven, J; Schuit, E; van Tetering, Aac; Mol, B W; Oei, S G

    OBJECTIVE: To investigate whether simulation-based obstetric team training in a simulation centre improves patient outcome. DESIGN: Multicentre, open, cluster randomised controlled trial. SETTING: Obstetric units in the Netherlands. POPULATION: Women with a singleton pregnancy beyond 24 weeks of

  15. Spinal cord stimulation in patients with painful diabetic neuropathy: a multicentre randomised clinical trial

    DEFF Research Database (Denmark)

    de Vos, Cecile C; Meier, Kaare; Zaalberg, Paul Brocades

    2014-01-01

    Painful diabetic neuropathy (PDN) is a peripheral neuropathic pain condition that is often difficult to relieve. Spinal cord stimulation (SCS) is a proven effective therapy for various types of mixed neuropathic conditions, yet effectiveness of SCS treatment for PDN is not well established. To our......D questionnaires also showed that patients in the SCS group, unlike those in the control group, experienced reduced pain and improved health and quality of life after 6 months of treatment. In patients with refractory painful diabetic neuropathy, spinal cord stimulation therapy significantly reduced...... knowledge, ours is the first multicentre randomized controlled trial investigating the effectiveness of SCS in patients with PDN. Sixty patients with PDN in the lower extremities refractory to conventional medical therapy were enrolled and followed for 6 months. They were randomized 2:1 to best conventional...

  16. Attachment Styles of Dermatological Patients in Europe: A Multi-centre Study in 13 Countries.

    Science.gov (United States)

    Szabó, Csanád; Altmayer, Anita; Lien, Lars; Poot, Françoise; Gieler, Uwe; Tomas-Aragones, Lucía; Kupfer, Jörg; Jemec, Gregor B E; Misery, Laurent; Linder, M Dennis; Sampogna, Francesca; van Middendorp, Henriët; Halvorsen, Jon Anders; Balieva, Flora; Szepietowski, Jacek C; Romanov, Dmitry; Marron, Servando E; Altunay, Ilknur K; Finlay, Andrew Y; Salek, Sam S; Dalgard, Florence

    2017-07-06

    Attachment styles of dermatological outpatients and satisfaction with their dermatologists were investigated within the framework of a multicentre study conducted in 13 European countries, organized by the European Society for Dermatology and Psychiatry. Attachment style was assessed with the Adult Attachment Scale. Patient satisfaction with the dermatologist was assessed with an 11-degree scale. A total of 3,635 adult outpatients and 1,359 controls participated in the study. Dermatological outpatients were less able to depend on others, were less comfortable with closeness and intimacy, and experienced similar rates of anxiety in relationships as did the controls. Participants who had secure attachment styles reported stressful life events during the last 6 months significantly less often than those who had insecure attachment styles. Patients with secure attachment styles tended to be more satisfied with their dermatologist than did insecure patients. These results suggest that secure attachment of dermatological outpatients may be a protective factor in the management of stress.

  17. Sensitivity of enhanced MRI for the detection of breast cancer: new, multicentric, residual, and recurrent

    International Nuclear Information System (INIS)

    Davis, P.L.; McCarty, K.S. Jr.

    1997-01-01

    Magnetic resonance imaging (MRI) of the breast brings the advantages of high resolution cross-sectional imaging to breast cancer diagnosis, treatment and research: improved cancer detection, staging, selection of therapy, evaluation of therapeutic response in vivo, detection of recurrence, and even the development of new therapies. Until now breast cancer treatment and research has been impeded by the limited means of evaluating the breast cancer in vivo: primarily clinical palpation and mammography of the breast tumor. A review of the initial studies shows that with the use of paramagnetic contrast agents, MRI has a sensitivity of 96 % for detecting breast cancers. MRI detects multicentric disease with a sensitivity of 98 %, superior to any other modality. The ability of MRI to detect recurrent local breast cancer in the conservatively treated breast is nearly 100 %. MRI is capable of monitoring tumor response to chemotherapy and actually guiding therapeutic interventions such as interstitial laser photocoagulation. (orig.)

  18. Clinical and echocardiographic assessment of the Medtronic Advantage aortic valve prosthesis: the Scandinavian multicentre, prospective study

    DEFF Research Database (Denmark)

    Haaverstad, Rune; Vitale, Nicola; Karevold, Asbjørn

    2006-01-01

    OBJECTIVE: The aim of this report is the prospective, multicentre evaluation of clinical results and haemodynamic performance of the Medtronic Advantage aortic valve prosthesis. METHODS: From April 2001 to June 2003, 166 patients (male:female 125:41; mean (SD) age 61.8 (11.8) years) received...... an aortic advantage valve prosthesis. Complete cumulative follow-up was 242.7 patient-years (maximum 3.2; mean 1.6 years). Postoperatively, patients underwent early (within 30 days) and 1 year transthoracic echocardiography. RESULTS: 30 day mortality was 2.4% (n = 4). Kaplan-Meier estimates of freedom from...... echocardiography. CONCLUSIONS: Haemodynamic performance and early clinical results of Medtronic advantage in the aortic position were satisfactory and comparable with those of other bileaflet valves in current clinical use....

  19. The role of dosimetry audit in lung SBRT multi-centre clinical trials.

    Science.gov (United States)

    Clark, Catharine H; Hurkmans, Coen W; Kry, Stephen F

    2017-12-01

    Stereotactic Body Radiotherapy (SBRT) in the lung is a challenging technique which requires high quality clinical trials to answer the un-resolved clinical questions. Quality assurance of these clinical trials not only ensures the safety of the treatment of the participating patients but also minimises the variation in treatment, thus allowing the lowest number of patient treatments to answer the trial question. This review addresses the role of dosimetry audits in the quality assurance process and considers what can be done to ensure the highest accuracy of dose calculation and delivery and it's assessment in multi-centre trials. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

  20. Multicentre evaluation of a novel vaginal dose reporting method in 153 cervical cancer patients

    DEFF Research Database (Denmark)

    Westerveld, Henrike; de Leeuw, Astrid; Kirchheiner, Kathrin

    2016-01-01

    Background and purpose Recently, a vaginal dose reporting method for combined EBRT and BT in cervical cancer patients was proposed. The current study was to evaluate vaginal doses with this method in a multicentre setting, wherein different applicators, dose rates and protocols were used. Material...... and methods In a subset of patients from the EMBRACE study, vaginal doses were evaluated. Doses at the applicator surface left/right and anterior/posterior and at 5 mm depth were measured. In addition, the dose at the Posterior–Inferior Border of Symphysis (PIBS) vaginal dose point and PIBS±2 cm......, corresponding to the mid and lower vagina, was measured. Results 153 patients from seven institutions were included. Large dose variations expressed in EQD2 with α/β = 3 Gy were seen between patients, in particular at the top left and right vaginal wall (median 195 (range 61–947) Gy/178 (61–980) Gy...

  1. Obstetric risk indicators for labour dystocia in nulliparous women: a multi-centre cohort study

    DEFF Research Database (Denmark)

    Kjaergaard, H.; Olsen, J.; Ottesen, Bent Smedegaard

    2008-01-01

    for dystocia often do not provide diagnostic criteria for the diagnosis. The aim of the present study was to identify obstetric and clinical risk indicators of dystocia defined by strict and explicit criteria. METHODS: A multi-centre population based cohort study with prospectively collected data from 2810...... nulliparous women in term spontaneous labour with a singleton infant in cephalic presentation. Data were collected by self-administered questionnaires and clinical data-records. Logistic regression analyses were used to estimate adjusted Odds Ratios (OR) and 95% confidence intervals (CI) are given. RESULTS...... fetal head-to-cervix contact (1.83, 1.31-2.56). The use of epidural analgesia (5.65, 4.33-7.38) was also associated with dystocia. CONCLUSION: Vaginal examinations at admission provide useful information on risk indicators for dystocia. The strongest risk indicator was use of epidural analgesia...

  2. National multicentre audit of pregnancy status in general surgery admissions in Scotland.

    Science.gov (United States)

    Wilson, Michael S J; Powell-Bowns, Matilda; Robertson, Andrew G; Luhmann, Andreas; Richards, Colin H

    2017-08-01

    Documentation of pregnancy status (PS) is an integral component of the assessment of women of reproductive age when admitted to hospital. Our aim was to determine how accurately PS was documented in a multicentre audit of female admissions to general surgery. A prospective multicentre audit of elective and emergency admissions was performed in 18 Scottish centres between 08:00 on 11 May 2015 and 07:59 on 25 May 2015. The lower age limit was the minimum age for admission to the adult surgical ward and the upper age limit was 55 years. There were 2743 admissions, with 612 (22.3%) women of reproductive age. After 82 exclusions, the final total was 530: 169 (31.9%) elective and 361 (68.1%) emergency. Documentation of PS was achieved in 274 (51.7%) cases: 52 (30.8%) elective and 222 (61.5%) emergency. In 318 (88.1%) of the emergency admissions, the patient had abdominal pain. Of these, 211 (65.1%) had a documented PS. The possibility of pregnancy was established in 237 (44.7%) cases. Establishing the possibility of pregnancy before surgery is poor, particularly in the elective setting. Objective documentation of PS in the emergency setting in those with abdominal pain is also poor. Our study highlights an important safety issue in the management of female patients. We advocate electronic storage of pregnancy test results and new guidelines to cover both elective and emergency surgery. PS should form part of the pre-theatre safety brief and checklist. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  3. An internet-based learning portfolio in resident education: the KOALA multicentre programme.

    Science.gov (United States)

    Fung, M F; Walker, M; Fung, K F; Temple, L; Lajoie, F; Bellemare, G; Bryson, S C

    2000-06-01

    To describe the Computerized Obstetrics and Gynecology Automated Learning Anaalysis (KOALAtrade mark), a multicentre, Internet-based learning portfolio and to determine its effects on residents' perception of their self-directed learning abilities. The KOALA programme allows residents to record their obstetrical, surgical, ultrasound, and ambulatory patient encounters and to document critical incidents of learning or elements of surprise that arose during these encounters. By prompting the student to reflect on these learning experiences, KOALA encourages residents to articulate questions which can be directly pursued through hypertext links to evidence-based literature. Four Canadian residency training programmes participated in the pilot project, from February to May 1997, using a dynamic relational database with a central server. All participants completed the Self-directed Learning Readiness Scale and a learning habits questionnaire. The impact of the KOALA programme on residents' perception of their self-directed learning abilities was measured by comparing KOALA-naive schools (schools 2, 3, and 4) with school 1 (exposed to the KOALA prototype for 1 year). Ordered variables were compared using the Mann-Whitney U test and continuous variables with the Student t test (statistical significance P learning were recorded by 41 residents in the four participating universities. Residents at the exposed school (school 1) had a significantly higher perception of their self-directed learning (P learning was less likely to be from continuing medical education (P learning portfolio with online resources. This Internet-based, multi-user, multicentre learning portfolio has a significant effect on residents' perception of their self-directed learning abilities.

  4. Role of the internet as an information resource before anaesthesia consultation: A French prospective multicentre survey.

    Science.gov (United States)

    Nucci, Bastian; Claret, Pierre-Geraud; Leclerc, Gilles; Chaumeron, Arnaud; Grillo, Philippe; Buleon, Clément; Leprince, Vincent; Raux, Mathieu; Minville, Vincent; Futier, Emmanuel; Lefrant, Jean-Yves; Cuvillon, Philippe

    2017-12-01

    Use of the internet as an information search tool has increased dramatically. Our study assessed preoperative use of the internet by patients to search for information regarding anaesthesia, surgery, pain or outcomes. The aim of this study was to test whether patients used the internet prior to surgery and what kinds of information they looked for (anaesthetic technique, pain, adverse events, outcomes and surgery). Correlation between patient age and information sought about surgery from the internet was also explored. A prospective multicentre observational study. In total, 14 French private and public institutions from May 2015 to January 2016. In total, 3161 adult patients scheduled for elective surgery under regional or general anaesthesia. An anonymous questionnaire was presented to adult patients scheduled for elective surgery under regional or general anaesthesia for completion before the first meeting with the anaesthesiologist. The investigator at each centre completed specific items that the patient could not complete. We defined the primary endpoint as the number of patients who searched for information about their anaesthesia or surgery on the internet by the time of the their preanaesthetic consultation. Of the 3234 questionnaires distributed, responses were received from 3161 patients. Within this respondent sample, 1304 (45%) were professionally active and 1664 (59%) used the internet at least once per day. Among 3098 (98%) patients who answered the question concerning the primary endpoint, 1506 (48%) had searched the internet for information about their health. In total, 784 (25%) used the internet to find information about their surgery and 113 (3.5%) looked for specific information about anaesthesia. Of the 3161, 52% reported difficulty searching for appropriate information about anaesthesia on the internet. 'Daily use of the web' [odds ratio (OR) 2.0; (95% CI: 1.65 to 2.55) P internet was not widely used by patients scheduled for elective

  5. Effects of combined exercise training and electromyostimulation treatments in chronic heart failure: A prospective multicentre study.

    Science.gov (United States)

    Iliou, Marie C; Vergès-Patois, Bénédicte; Pavy, Bruno; Charles-Nelson, Anais; Monpère, Catherine; Richard, Rudy; Verdier, Jean C

    2017-08-01

    Background Exercise training as part of a comprehensive cardiac rehabilitation is recommended for patients with cardiac heart failure. It is a valuable method for the improvement of exercise tolerance. Some studies reported a similar improvement with quadricipital electrical myostimulation, but the effect of combined exercise training and electrical myostimulation in cardiac heart failure has not been yet evaluated in a large prospective multicentre study. Purpose The aim of this study was to determine whether the addition of low frequency electrical myostimulation to exercise training may improve exercise capacity and/or muscular strength in cardiac heart failure patients. Methods Ninety-one patients were included (mean age: 58 ± 9 years; New York Heart Association II/III: 52/48%, left ventricular ejection fraction: 30 ± 7%) in a prospective French study. The patients were randomised into two groups: 41 patients in exercise training and 50 in exercise training + electrical myostimulation. All patients underwent 20 exercise training sessions. In addition, in the exercise training + electrical myostimulation group, patients underwent 20 low frequency (10 Hz) quadricipital electrical myostimulation sessions. Each patient underwent a cardiopulmonary exercise test, a six-minute walk test, a muscular function evaluation and a quality of life questionnaire, before and at the end of the study. Results A significant improvement of exercise capacity (Δ peak oxygen uptake+15% in exercise training group and +14% in exercise training + electrical myostimulation group) and of quality of life was observed in both groups without statistically significant differences between the two groups. Mean creatine kinase level increased in the exercise training group whereas it remained stable in the combined group. Conclusions This prospective multicentre study shows that electrical myostimulation on top of exercise training does not demonstrate any significant

  6. A comparison of functional outcome in patients sustaining major trauma: a multicentre, prospective, international study.

    Directory of Open Access Journals (Sweden)

    Timothy H Rainer

    Full Text Available OBJECTIVES: To compare 6 month and 12 month health status and functional outcomes between regional major trauma registries in Hong Kong and Victoria, Australia. SUMMARY BACKGROUND DATA: Multicentres from trauma registries in Hong Kong and the Victorian State Trauma Registry (VSTR. METHODS: Multicentre, prospective cohort study. Major trauma patients and aged ≥18 years were included. The main outcome measures were Extended Glasgow Outcome Scale (GOSE functional outcome and risk-adjusted Short-Form 12 (SF-12 health status at 6 and 12 months after injury. RESULTS: 261 cases from Hong Kong and 1955 cases from VSTR were included. Adjusting for age, sex, ISS, comorbid status, injury mechanism and GCS group, the odds of a better functional outcome for Hong Kong patients relative to Victorian patients at six months was 0.88 (95% CI: 0.66, 1.17, and at 12 months was 0.83 (95% CI: 0.60, 1.12. Adjusting for age, gender, ISS, GCS, injury mechanism and comorbid status, Hong Kong patients demonstrated comparable mean PCS-12 scores at 6-months (adjusted mean difference: 1.2, 95% CI: -1.2, 3.6 and 12-months (adjusted mean difference: -0.4, 95% CI: -3.2, 2.4 compared to Victorian patients. Keeping age, gender, ISS, GCS, injury mechanism and comorbid status, there was no difference in the MCS-12 scores of Hong Kong patients compared to Victorian patients at 6-months (adjusted mean difference: 0.4, 95% CI: -2.1, 2.8 or 12-months (adjusted mean difference: 1.8, 95% CI: -0.8, 4.5. CONCLUSION: The unadjusted analyses showed better outcomes for Victorian cases compared to Hong Kong but after adjusting for key confounders, there was no difference in 6-month or 12-month functional outcomes between the jurisdictions.

  7. Primary adrenal insufficiency in adult population: a Portuguese Multicentre Study by the Adrenal Tumours Study Group.

    Science.gov (United States)

    Ferreira, Lia; Silva, João; Garrido, Susana; Bello, Carlos; Oliveira, Diana; Simões, Hélder; Paiva, Isabel; Guimarães, Joana; Ferreira, Marta; Pereira, Teresa; Bettencourt-Silva, Rita; Martins, Ana Filipa; Silva, Tiago; Fernandes, Vera; Pereira, Maria Lopes

    2017-11-01

    Primary adrenal insufficiency (PAI) is a rare but severe and potentially life-threatening condition. No previous studies have characterized Portuguese patients with PAI. To characterize the clinical presentation, diagnostic workup, treatment and follow-up of Portuguese patients with confirmed PAI. This multicentre retrospective study examined PAI patients in 12 Portuguese hospitals. We investigated 278 patients with PAI (55.8% were females), with a mean age of 33.6 ± 19.3 years at diagnosis. The most frequent presenting clinical features were asthenia (60.1%), mucocutaneous hyperpigmentation (55.0%) and weight loss (43.2%); 29.1% of the patients presented with adrenal crisis. Diagnosis was established by high plasma ACTH and low serum cortisol in most patients (43.9%). The most common aetiology of PAI was autoimmune adrenalitis (61.0%). There were 38 idiopathic cases. Autoimmune comorbidities were found in 70% of the patients, the most frequent being autoimmune thyroiditis (60.7%) and type 1 diabetes mellitus (17.3%). Seventy-nine percent were treated with hydrocortisone (mean dose 26.3 ± 8.3 mg/day) mostly in three (57.5%) or two (37.4%) daily doses. The remaining patients were treated with prednisolone (10.1%), dexamethasone (6.2%) and methylprednisolone (0.7%); 66.2% were also on fludrocortisone (median dose of 100 µg/day). Since diagnosis, 33.5% of patients were hospitalized for disease decompensation. In the last appointment, 17.2% of patients had complaints (7.6% asthenia and 6.5% depression) and 9.7% had electrolyte disturbances. This is the first multicentre Portuguese study regarding PAI. The results emphasize the need for standardization in diagnostic tests and etiological investigation and provide a framework for improving treatment. © 2017 The authors.

  8. The organisation of physiotherapy for people with multiple sclerosis across Europe: a multicentre questionnaire survey.

    Science.gov (United States)

    Rasova, Kamila; Freeman, Jenny; Martinkova, Patricia; Pavlikova, Marketa; Cattaneo, Davide; Jonsdottir, Johanna; Henze, Thomas; Baert, Ilse; Van Asch, Paul; Santoyo, Carme; Smedal, Tori; Beiske, Antonie Giæver; Stachowiak, Małgorzata; Kovalewski, Mariusz; Nedeljkovic, Una; Bakalidou, Daphne; Guerreiro, José Manuel Alves; Nilsagård, Ylva; Dimitrova, Erieta Nikolikj; Habek, Mario; Armutlu, Kadriye; Donzé, Cécile; Ross, Elaine; Ilie, Ana Maria; Martić, Andrej; Romberg, Anders; Feys, Peter

    2016-10-06

    Understanding the organisational set-up of physiotherapy services across different countries is increasingly important as clinicians around the world use evidence to improve their practice. This also has to be taken into consideration when multi-centre international clinical trials are conducted. This survey aimed to systematically describe organisational aspects of physiotherapy services for people with multiple sclerosis (MS) across Europe. Representatives from 72 rehabilitation facilities within 23 European countries completed an online web-based questionnaire survey between 2013 and 2014. Countries were categorised according to four European regions (defined by United Nations Statistics). Similarities and differences between regions were examined. Most participating centres specialized in rehabilitation (82 %) and neurology (60 %), with only 38 % specialising in MS. Of these, the Western based Specialist MS centres were predominately based on outpatient services (median MS inpatient ratio 0.14), whilst the Eastern based European services were mostly inpatient in nature (median MS inpatient ratio 0.5). In almost all participating countries, medical doctors - specialists in neurology (60 %) and in rehabilitation (64 %) - were responsible for referral to/prescription of physiotherapy. The most frequent reason for referral to/prescription of physiotherapy was the worsening of symptoms (78 % of centres). Physiotherapists were the most common members of the rehabilitation team; comprising 49 % of the team in Eastern countries compared to approximately 30 % in the rest of Europe. Teamwork was commonly adopted; 86 % of centres based in Western countries utilised the interdisciplinary model, whilst the multidisciplinary model was utilised in Eastern based countries (p = 0.046). This survey is the first to provide data about organisational aspects of physiotherapy for people with MS across Europe. Overall, care in key organisational aspects of service

  9. Imaging features of multicentric Castleman's disease in HIV infection

    Energy Technology Data Exchange (ETDEWEB)

    Hillier, J.C. E-mail: chris_julia.hillier@talk21.com; Shaw, P.; Miller, R.F.; Cartledge, J.D.; Nelson, M.; Bower, M.; Francis, N.; Padley, S.P

    2004-07-01

    AIM: To describe the computed tomography (CT) features of human immunodeficiency virus (HIV)-associated Castleman's disease. MATERIALS AND METHODS: Nine HIV-positive patients with biopsy-proven Castleman's disease were studied. Clinical and demographic data, CD4 count, histological diagnosis and human herpes type 8 (HHV8) serology or immunostaining results were recorded. CT images were reviewed independently by two radiologists. RESULTS: CT findings included splenomegaly (n=7) and peripheral lymph node enlargement (axillary n=8, inguinal n=4). All nodes displayed mild to avid enhancement after intravenous administration of contrast material. Hepatomegaly was evident in seven patients. Other features included abdominal (n=6) and mediastinal (n=5) lymph node enlargement and pulmonary abnormalities (n=4). Patterns of parenchymal abnormality included bronchovascular nodularity (n=2), consolidation (n=1) and pleural effusion (n=2). On histological examination eight patients (spleen n=3, lymph node n=9, lung n=1 bone marrow n=1) had the plasma cell variant and one had mixed hyaline-vascular/plasma cell variant. The majority had either positive immunostaining for HHV8 or positive serology (n=8). CONCLUSION: Common imaging features of multicentric Castleman's disease in HIV infection are hepatosplenomegaly and peripheral lymph node enlargement. Although these imaging features may suggest the diagnosis in the appropriate clinical context, they lack specificity and so biopsy is needed for diagnosis. In distinction from multicentric Castleman's disease in other populations the plasma cell variant is most commonly encountered, splenomegaly is a universal feature and there is a strong association with Kaposi's sarcoma.

  10. Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings.

    Science.gov (United States)

    Dickson, Sylvia; Logan, Janet; Hagen, Suzanne; Stark, Diane; Glazener, Cathryn; McDonald, Alison M; McPherson, Gladys

    2013-11-15

    Successful recruitment of participants to any trial is central to its success. Trial results are routinely published, and recruitment is often cited to be slower and more difficult than anticipated. This article reflects on the methodological challenges of recruiting women with prolapse attending United Kingdom (UK) gynaecology outpatient clinics to a multi-centre randomised controlled trial (RCT) of physiotherapy, and the systems put in place in an attempt to address them. Gynaecology outpatients with symptomatic prolapse were to be recruited over a 16-month period from 14 UK hospitals and one New Zealand hospital. Eligible women were informed about the trial by their gynaecologist and informed consent was obtained by the central trial office. Recruitment difficulties were encountered early on, and a number of strategies were employed to try to improve recruitment. Some strategies were more successful than others and they differed in the resources required. Actions that facilitated recruitment included increasing recruiting centres to 23 UK and two international hospitals, good centre support, using processes embedded in clinical practice, and good communication between the trial office, collaborators and participants. Collaborator incentives, whereby staff involved received the benefit immediately, were more successful than a nominal monetary payment per woman randomised. Barriers to recruitment included fewer eligible women than anticipated, patient's preference to receive active treatment rather than allocation to the control group, lack of support staff and high staff turnover. Geographical variations in Primary Care Trust Research Management and Governance approval systems and general practitioner (GP) referral procedures also impacted negatively on recruitment. Our article reflects on the methodological challenges of recruiting to a multi-centre RCT in a UK gynaecology setting. Effective interventions included increasing the number of recruiting centres and

  11. Computers and internet in dental education system of Kerala, South India: A multicentre study

    Directory of Open Access Journals (Sweden)

    Kanakath Harikumar

    2015-01-01

    Full Text Available Computers and internet have exerted a tremendous effect on dental education programs all over the world. A multicenter study was done to assess trends in computer and internet usage among the dental students and faculty members across the South Indian state, Kerala. A total of 347 subjects participated in the study. All participants were highly competent with the use of computers and internet. 72.3% of the study subjects preferred hard copy textbooks to PDF format books. 81.3% of the study subjects thought that internet was a useful adjunct to dental education. 73.8% of the study subjects opined that computers and internet could never be a replacement to conventional classroom teaching. Efforts should be made to provide greater infrastructure with regard to computers and internet such as Wi-Fi, free, unlimited internet access to all students and faculty members.

  12. Demonstration of the metaphylactic use of gamithromycin against bacterial pathogens associated with bovine respiratory disease in a multicentre farm trial

    OpenAIRE

    Baggott, D.; Casartelli, A.; Fraisse, F.; Manavella, C.; Marteau, R.; Rehbein, S.; Wiedemann, M.; Yoon, S.

    2011-01-01

    On five commercial cattle rearing sites across Europe, a total of 802 young cattle at high risk of developing bovine respiratory disease (BRD) associated with the bacterial pathogens Mannheimia haemolytica or Pasteurella multocida and/or Mycoplasma bovis were enrolled into a multicentre, controlled field trial. Half were treated with a single dose of gamithromycin at 6 mg/kg bodyweight by subcutaneous injection and half received an injection of a saline placebo as the control. All animals wer...

  13. A Japanese cross-sectional multicentre study of biomarkers associated with cardiovascular disease in smokers and non-smokers

    OpenAIRE

    L?dicke, Frank; Magnette, John; Baker, Gizelle; Weitkunat, Rolf

    2015-01-01

    Abstract We performed a cross-sectional, multicentre study in Japan to detect the differences in biomarkers of exposure and cardiovascular biomarkers between smokers and non-smokers. Several clinically relevant cardiovascular biomarkers differed significantly between smokers and non-smokers, including lipid metabolism (high-density lipoprotein cholesterol concentrations ? lower in smokers), inflammation (fibrinogen and white blood cell count ? both higher in smokers), oxidative stress (8-epi-...

  14. Multicentric Evaluation of New Commercial Enzyme Immunoassays for the Detection of Immunoglobulin M and Total Antibodies against Hepatitis A Virus▿

    Science.gov (United States)

    Arcangeletti, M. C.; Dussaix, E.; Ferraglia, F.; Roque-Afonso, A. M.; Graube, A.; Chezzi, C.

    2011-01-01

    A multicentric clinical study was conducted on representative sera from 1,738 European and U.S. subjects for the evaluation of new anti-hepatitis A virus enzyme immunoassays from Bio-Rad Laboratories. Comparison with reference DiaSorin S.p.A. tests confirmed the good performance of Bio-Rad assays (99.85% and 99.47% overall agreement in detecting total antibodies and IgM, respectively). PMID:21653739

  15. Advantages of the modified double ring areolar incision over the traditional areolar incision in multicentric breast fibroadenoma surgery.

    Science.gov (United States)

    Zhang, Mingliang; Shen, Gongjin; Zhang, Song; Cui, Zhen; Qian, Jun

    2017-09-01

    This study was conducted to investigate the clinical advantages of modified double ring areola incision (MDRAI) compared to ordinary areola incision (OAI) in multicentric breast fibroadenoma in women. Sixty cases of multicentric benign breast tumor were recruited from the First Affiliated Hospital of Bengbu Medical College from January to December 2016. The cases were divided into two groups according to surgical approach: MDRAI (n = 20) and OAI (n = 40). The operation duration, intraoperative blood loss, drainage time, and postoperative recurrence rate in the first six months were compared. The mean age and tumor locations were not statistically different between the groups (P > 0.05). However, more lesions and larger tumor diameter were found in the MDRAI group than in the OAI group, with statistical difference (P  0.05). However, the intraoperative blood loss was statistically different between the two groups (P < 0.05). All 60 cases received six months of follow-up. Eight recurrent cases were found in the OAI group, but none in the MDRAI group. The recurrence rate was significantly different (χ 2  = 4.62, P < 0.05). Compared with OAI, MDRAI offers greater advantages in the aspects of blood loss and recurrence for the treatment of breast benign tumor, especially for multicentric larger lesions. © 2017 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd.

  16. Prediction of risk of depressive symptoms in menopausal women based on hot flash and sweating symptoms: a multicentre study

    Directory of Open Access Journals (Sweden)

    Zheng YW

    2017-11-01

    Full Text Available Yanwei Zheng,1 Yibei Zhou,1 Jiangshan Hu,1 Jieping Zhu,2 Qi Hua,3 Minfang Tao1 1Department of Gynecology and Obstetrics, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, 2Department of Gynecology and Obstetrics, Shanghai Sixth People’s Hospital East Branch, 3Department of Gynecology and Obstetrics, International Peace Maternal and Child Health Hospital of the China Welfare Institute, Shanghai, People’s Republic of China Objective: The present study aimed to develop a symptom-based (namely, hot flashes and sweating scoring system for predicting the risk of depressive symptoms in menopausal women via a multicentre cross-sectional survey. Methods: The data examined in the present study were obtained from 1,004 women aged 40–60 years who underwent physical examination at A Hospital. The basic information was obtained using a questionnaire-based survey. A self-rating depression scale was used to obtain the depressive symptom scores, while the Kupperman Menopausal Index was used to obtain the scores for the frequency of hot flashes and sweating. A logistic regression model was also established. The resulting β coefficient was employed to calculate and predict the risk of depressive symptoms in these women and a risk scoring system was established. The scoring system was validated using samples from 2 other centers (validation sample 1: B Hospital, 440 women; validation sample 2: C Hospital, 247 women. Results: The scoring system developed to predict the risk of depressive symptoms in menopausal women was based on hot flash and sweating symptoms and associated with menopausal status, hot flash scores, education level (high school education and below and being diabetic. The scoring system yielded a total score of 0–54 points. For women in the study sample, the area under the curve (AUC of depressive symptom risk score was 0.750 (95% CI, 0.708–0.793. Validation sample 1 had an AUC of 0.731 (95% CI, 0.667–0.794, while

  17. Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220

    Directory of Open Access Journals (Sweden)

    Jimenez Carmen

    2005-10-01

    Full Text Available Abstract Background Although the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis. Methods/design Randomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis. The patients will be randomised into two groups: 1 experimental (acupuncture + physiotherapy; 2 control (TENS-placebo + physiotherapy; the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA Scale

  18. [Effectivity and satisfaction with the treatment for dyslipidemia with pitavastatin. Multicentric, descriptive, post authorised and observational study (REINA study)].

    Science.gov (United States)

    Rodríguez Arroyo, Luis Alberto; Díaz Rodríguez, Angel; Pintó Sala, Xavier; Coca Payeras, Antonio; Rius Tarruella, Joan

    2014-01-01

    Evaluating the therapeutical adherence as well as the patient' satisfaction with the treatment should be considered to optimize lipidic control. The REINA Study evaluates the grade of satisfaction in dyslipidemic patients treated with pitavastatin. The current study was observational, descriptive, transversal and multi-centric with patients from our country only. The following data were collected in each case: Morisky-Green test and TSQM-9 for patients older than 18 years old, with dyslipidemia treated with pitavastatin in the last 12 weeks. We studied 6,489 patients (60.0% males) from Primary Health (52.7%) and Specialised Health (47.3%), with age (mean) = 60.9 ± 11.2 years by aleatory sampling. 72.3% of patients achieved an adequate control with 2mg/day of pitavastatin. General satisfaction with the treatment was 73.20 points (95% CI: 58.17-87.23). Patients who followed the treatment (65%) showed better data of satisfaction with the drug (77.70 [95% CI: 65.20-90.20]), of global satisfaction (75.00 [95% CI: 61.50-88.50]) and their satisfaction with the drug efficiency was higher (72.50 [95% CI: 57.70-87.30]) than in the patients who did not finish the treatment (72.70 [95% CI: 59.30-85.74]; 68.5 [95% CI: 53.20-83.80] and 67.80 [95% CI: 53.70-81.90], respectively), P < .0001, without any difference between the two primary care systems. The validation of the satisfaction is a crucial indicator in the evaluation of the services offered in health. Patients with the highest grade of satisfaction present better therapeutical adherence, and such a relation is bidirectional. The individuals who are satisfied and who followed the treatment obtained better clinical results. Pitavastatin is an effective therapeutic alternative for patients with dyslipidemia. Copyright © 2013 Sociedad Española de Arteriosclerosis. Published by Elsevier España. All rights reserved.

  19. Characterization of methicillin-susceptible and -resistant staphylococci in the clinical setting: a multicentre study in Nigeria.

    Science.gov (United States)

    Shittu, Adebayo; Oyedara, Omotayo; Abegunrin, Fadekemi; Okon, Kenneth; Raji, Adeola; Taiwo, Samuel; Ogunsola, Folasade; Onyedibe, Kenneth; Elisha, Gay

    2012-11-02

    The staphylococci are implicated in a variety of human infections; however, many clinical microbiology laboratories in Nigeria do not identify staphylococci (in particular coagulase negative staphylococci - CNS) to the species level. Moreover, data from multi-centre assessment on antibiotic resistance and epidemiology of the staphylococci are not available in Nigeria. This study investigated 91 non-duplicate staphylococcal isolates obtained from the microbiology laboratories of eight hospitals in Nigeria during the period January to April 2010. Identification and antibiotic susceptibility testing was performed using the VITEK 2 system, detection of resistance genes by PCR, and molecular characterization was determined by SCCmec typing, spa and multilocus sequence typing (MLST). All the isolates were susceptible to mupirocin, tigecycline, vancomycin and linezolid, but 72.5% of CNS and 82.3% of Staphylococcus aureus were resistant to cotrimoxazole, while multiresistance was observed in 37 of the 40 CNS isolates. Untypeable SCCmec types (ccrC/Class A mec and ccr-negative/Class C2 mec gene complex) in two methicillin-resistant S. aureus (MRSA) were identified. Additionally, ccr-negative/Class A mec and ccr type 4/Class C2 mec gene complex was detected in one isolate each of S. sciuri and S. haemolyticus, respectively. The S. aureus isolates were classified into 21 spa types including two new types (t8987, t9008) among the methicillin-susceptible S. aureus (MSSA) isolates. Two (CC8-SCCmecnon-typeable and CC88-SCCmec IV) and four (CC8-SCCmec III/IV/V; CC30-SCCmec II/III; CC88-SCCmec IV; and ST152-SCCmecnon-typeable) MRSA clones were identified in Maiduguri (North-East Nigeria) and South-West Nigeria, respectively. The proportion of Panton-Valentine leukocidin (PVL)-positive MSSA was high (44.4%) and 56.3% of these strains were associated with sequence type (ST) 152. The identification of multiresistant mecA positive S. haemolyticus and S. sciuri from clinical samples

  20. Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220

    Science.gov (United States)

    Vas, Jorge; Perea-Milla, Emilio; Mendez, Camila; Galante, Antonia Herrera; Madrazo, Fernando; Medina, Ivan; Ortega, Caridad; Olmo, Victoria; Fernandez, Francisco Perez; Hernandez, Luz; Seminario, Jose Maria; Brioso, Mauricio; Luna, Francisco; Gordo, Isabel; Godoy, Ana Maria; Jimenez, Carmen; Ruiz, Manuel Anselmo; Montes, Joaquin; Hidalgo, Alonso; Gonzalez-Quevedo, Rosa; Bosch, Pablo; Vazquez, Antonio; Lozano, Juan Vicente

    2005-01-01

    Background Although the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). Methods/design Randomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). The patients will be randomised into two groups: 1) experimental (acupuncture + physiotherapy); 2) control (TENS-placebo + physiotherapy); the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA) Scale; as secondary

  1. Inflammatory Bowel Disease Phenotype as Risk Factor for Cancer in a Prospective Multicentre Nested Case-Control IG-IBD Study.

    Science.gov (United States)

    Biancone, Livia; Armuzzi, Alessandro; Scribano, Maria Lia; D'Inca, Renata; Castiglione, Fabiana; Papi, Claudio; Angelucci, Erika; Daperno, Marco; Mocciaro, Filippo; Riegler, Gabriele; Fries, Walter; Meucci, Gianmichele; Alvisi, Patrizia; Spina, Luisa; Ardizzone, Sandro; Petruzziello, Carmelina; Ruffa, Alessandra; Kohn, Anna; Vecchi, Maurizio; Guidi, Luisa; Di Mitri, Roberto; Renna, Sara; Emma, Calabrese; Rogai, Francesca; Rossi, Alessandra; Orlando, Ambrogio; Pallone, Francesco

    2016-08-01

    Cancer risk in inflammatory bowel disease [IBD] is still debated. In a prospective, multicentre, nested case-control study, we aimed to characterise incident cases of cancer in IBD. The role of immunomodulators vs clinical characteristics of IBD as risk factors for cancer was also investigated. From January 2012 to December 2014, each IBD patient with incident cancer was matched with two IBD patients without cancer for: IBD type, gender, and age. Risk factors were assessed by multivariate regression analysis. IBD patients considered numbered 44619: 21953 Crohn's disease [CD], 22666 ulcerative colitis [UC]. Cancer occurred in 174 patients: 99 CD [CD-K], 75 UC [UC-K]. Controls included 198 CD [CD-C], 150 UC [UC-C]. Cancer incidence in IBD was 3.9/1000, higher in CD (4.5/1000 [99/21,953]) than in UC (3.3/1000 [75/22,666]; p = 0.042). Cancers involved: digestive system [36.8%], skin [13.2%], urinary tract [12.1%], lung [8.6%], breast [8%], genital tract [6.9%], thyroid [4.6%], lymphoma [3.5%], others [6.3%]. In CD, penetrating behaviour and combined thiopurines and tumour necrosis factor alpha [TNFα] antagonists were risk factors for cancer overall: odds ratio [OR] (95% confidence interval [CI] 2.33 [1.01-5.47]); 1.97 [1.1-3.5]; and for extracolonic cancers 3.9 [1.56-10.1]; 2.15 [1.17-4.1], respectively. In UC, risk factors were pancolitis and disease-related surgery for cancer overall (OR: 2.52 [1.26-5.1]; 5.09 [1.73-17.1]); disease-related surgery for colorectal cancer [CRC] (OR 3.6 [1.0-12]); and extensive and left-sided vs distal UC for extracolonic cancers (OR: 2.55 [1.15-5.9]; 2.6 [1.04-6.6]), respectively. In a multicentre study, penetrating CD and extensive UC were risk factors for cancer overall. Cancer incidence was higher in CD than in UC. Copyright © 2016 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  2. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China

    Directory of Open Access Journals (Sweden)

    Zheng Hui

    2011-03-01

    Full Text Available Abstract Background In order to evaluate the safety of acupuncture in China objectively, we investigated the adverse events associated with acupuncture based on three multicentre randomized controlled trials (RCTs to assess the safety of acupuncture, identifying the common types of acupuncture adverse events, and analysing the related risk factors for their occurrence. Methods This observational study included patients who received acupuncture from three multicentre RCTs respectively for migraine, functional dyspepsia and Bell's palsy. The 1968 patients and their acupuncturists documented adverse events associated with acupuncture after treatment. We collected data about adverse events due to acupuncture treatment from their case report forms. We analysed the incidence and details of the adverse effects, and studied the risk factors for acupuncture adverse events with non-conditional logistic regression analysis. Results Among the 1968 patients, 74 patients (3.76% suffered at least one adverse event throughout the treatment period. We did not observe the occurrence of serious adverse events. 73 patients with adverse events recovered within 2 weeks through effective treatment such as physiotherapy or self-treatment. A total of 3 patients withdrew because of adverse events. There were 9 types of adverse events related to acupuncture, including subcutaneous haematoma, bleeding, skin bruising and needle site pain. Subcutaneous haematoma and haemorrhage in the needling points were the most common adverse events. Age and gender were related to the occurrence of acupuncture adverse events. The older the patients were, the higher the risk of adverse events was. In addition, male patients had slightly higher risk of an adverse event than female patients. Conclusions Acupuncture is a safe therapy with low risk of adverse events in clinical practice. The risk factors for adverse events (AEs were related to the patients' gender and age and the local

  3. Pregnancies in women with systemic lupus erythematosus and antiphospholipid antibodies

    DEFF Research Database (Denmark)

    Schreiber, K

    2016-01-01

    of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus (PROMISSE) study, so far the largest multicentre cohort study of pregnant women with underlying stable SLE, has given some important answers to long-discussed questions. Future studies on data collected from...

  4. Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study.

    Science.gov (United States)

    Noriega, David; Maestretti, Gianluca; Renaud, Christian; Francaviglia, Natale; Ould-Slimane, Mourad; Queinnec, Steffen; Ekkerlein, Helmut; Hassel, Frank; Gumpert, Rainer; Sabatier, Pascal; Huet, Hervé; Plasencia, Miguel; Theumann, Nicolas; Kunsky, Alexander; Krüger, Antonio

    2015-01-01

    This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score) and in quality of life (increase 21.1% of EQ-VAS score) were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (-5.4 ± 6.3°; p SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery.

  5. Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study

    Directory of Open Access Journals (Sweden)

    David Noriega

    2015-01-01

    Full Text Available This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF of traumatic origin. We enrolled 103 patients (median age: 61.6 years with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS. Secondary outcomes were Oswestry Disability Index (ODI, EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score and in quality of life (increase 21.1% of EQ-VAS score were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (-5.4±6.3°; p<0.001, remained at 12 months (-4.4±6.0°, p=0.002. No adverse events were implant-related and none required device removal. Three patients (2.9% experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery.

  6. MRI of the wrist in juvenile idiopathic arthritis: proposal of a paediatric synovitis score by a consensus of an international working group. Results of a multicentre reliability study

    International Nuclear Information System (INIS)

    Damasio, Maria Beatrice; Mattiuz, Chiara; Magnano, GianMichele; Malattia, Clara; Martini, Alberto; Tanturri de Horatio, Laura; Barbuti, Domenico; Toma, Paolo; Pistorio, Angela; Bracaglia, Claudia; Boavida, Peter; Ording, Lil Sophie Mueller; Juhan, Karen Lambot; Rosendahl, Karen

    2012-01-01

    MRI is a sensitive tool for the evaluation of synovitis in juvenile idiopathic arthritis (JIA). The purpose of this study was to introduce a novel MRI-based score for synovitis in children and to examine its inter- and intraobserver variability in a multi-centre study. Wrist MRI was performed in 76 children with JIA. On postcontrast 3-D spoiled gradient-echo and fat-suppressed T2-weighted spin-echo images, joint recesses were scored for the degree of synovial enhancement, effusion and overall inflammation independently by two paediatric radiologists. Total-enhancement and inflammation-synovitis scores were calculated. Interobserver agreement was poor to moderate for enhancement and inflammation in all recesses, except in the radioulnar and radiocarpal joints. Intraobserver agreement was good to excellent. For enhancement and inflammation scores, mean differences (95 % CI) between observers were -1.18 (-4.79 to 2.42) and -2.11 (-6.06 to 1.83). Intraobserver variability (reader 1) was 0 (-1.65 to 1.65) and 0.02 (-1.39 to 1.44). Intraobserver agreement was good. Except for the radioulnar and radiocarpal joints, interobserver agreement was not acceptable. Therefore, the proposed scoring system requires further refinement. (orig.)

  7. Data privacy management and data quality monitoring in the German Centre for Cardiovascular Research's multicentre TranslatiOnal Registry for CardiomyopatHies (DZHK‐TORCH)

    Science.gov (United States)

    Schwaneberg, Thea; Weitmann, Kerstin; Dösch, Andreas; Seyler, Claudia; Bahls, Thomas; Geidel, Lars; Stahl, Dana; Lee, Mahsa; Kraus, Monika; Katus, Hugo A.

    2017-01-01

    Abstract Aims The multicentric TranslatiOnal Registry for CardiomyopatHies (TORCH) of the German Centre for Cardiovascular Research aims to recruit 2300 patients with non‐ischemic cardiomyopthies. Methods and results The investigations were performed after standard operating procedures. The data are collected in standardized electronic case report forms provided by the data holding of the central data management of the German Centre for Cardiovascular Research using secuTrial (interActive Systems GmbH, Berlin, Germany). The personal‐identifying data and informed consent are collected, stored, and quality‐checked by the independent Trusted Third Party in Greifswald. The quality management of the medical data is performed by the data and quality centre Greifswald. In December 2014, the recruitment for TORCH has started. Currently, data and biomaterial from about 1397 patients and more than 74 500 biomaterial aliquots were collected. Regular study centre‐specific quality reports address completeness and plausibility of data and provide detailed information about current missing or implausible data entries to improve the data quality by using a query management in addition. Conclusions A regular quality control and reporting improve the data quality in TORCH and will support high‐quality data analysis and the translation of research results into routine care. PMID:28742243

  8. Data privacy management and data quality monitoring in the German Centre for Cardiovascular Research's multicentre TranslatiOnal Registry for CardiomyopatHies (DZHK-TORCH).

    Science.gov (United States)

    Schwaneberg, Thea; Weitmann, Kerstin; Dösch, Andreas; Seyler, Claudia; Bahls, Thomas; Geidel, Lars; Stahl, Dana; Lee, Mahsa; Kraus, Monika; Katus, Hugo A; Hoffmann, Wolfgang

    2017-11-01

    The multicentric TranslatiOnal Registry for CardiomyopatHies (TORCH) of the German Centre for Cardiovascular Research aims to recruit 2300 patients with non-ischemic cardiomyopthies. The investigations were performed after standard operating procedures. The data are collected in standardized electronic case report forms provided by the data holding of the central data management of the German Centre for Cardiovascular Research using secuTrial (interActive Systems GmbH, Berlin, Germany). The personal-identifying data and informed consent are collected, stored, and quality-checked by the independent Trusted Third Party in Greifswald. The quality management of the medical data is performed by the data and quality centre Greifswald. In December 2014, the recruitment for TORCH has started. Currently, data and biomaterial from about 1397 patients and more than 74 500 biomaterial aliquots were collected. Regular study centre-specific quality reports address completeness and plausibility of data and provide detailed information about current missing or implausible data entries to improve the data quality by using a query management in addition. A regular quality control and reporting improve the data quality in TORCH and will support high-quality data analysis and the translation of research results into routine care. © 2017 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

  9. Ataluren in patients with nonsense mutation Duchenne muscular dystrophy (ACT DMD): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.

    Science.gov (United States)

    McDonald, Craig M; Campbell, Craig; Torricelli, Ricardo Erazo; Finkel, Richard S; Flanigan, Kevin M; Goemans, Nathalie; Heydemann, Peter; Kaminska, Anna; Kirschner, Janbernd; Muntoni, Francesco; Osorio, Andrés Nascimento; Schara, Ulrike; Sejersen, Thomas; Shieh, Perry B; Sweeney, H Lee; Topaloglu, Haluk; Tulinius, Már; Vilchez, Juan J; Voit, Thomas; Wong, Brenda; Elfring, Gary; Kroger, Hans; Luo, Xiaohui; McIntosh, Joseph; Ong, Tuyen; Riebling, Peter; Souza, Marcio; Spiegel, Robert J; Peltz, Stuart W; Mercuri, Eugenio

    2017-09-23

    Duchenne muscular dystrophy (DMD) is a severe, progressive, and rare neuromuscular, X-linked recessive disease. Dystrophin deficiency is the underlying cause of disease; therefore, mutation-specific therapies aimed at restoring dystrophin protein production are being explored. We aimed to assess the efficacy and safety of ataluren in ambulatory boys with nonsense mutation DMD. We did this multicentre, randomised, double-blind, placebo-controlled, phase 3 trial at 54 sites in 18 countries located in North America, Europe, the Asia-Pacific region, and Latin America. Boys aged 7-16 years with nonsense mutation DMD and a baseline 6-minute walk distance (6MWD) of 150 m or more and 80% or less of the predicted normal value for age and height were randomly assigned (1:1), via permuted block randomisation (block size of four) using an interactive voice-response or web-response system, to receive ataluren orally three times daily (40 mg/kg per day) or matching placebo. Randomisation was stratified by age (DMD trials with the 6-minute walk test as the endpoint. PTC Therapeutics. Copyright © 2017 Elsevier Ltd. All rights reserved.

  10. Haptic-based neurorehabilitation in poststroke patients: a feasibility prospective multicentre trial for robotics hand rehabilitation.

    Science.gov (United States)

    Turolla, Andrea; Daud Albasini, Omar A; Oboe, Roberto; Agostini, Michela; Tonin, Paolo; Paolucci, Stefano; Sandrini, Giorgio; Venneri, Annalena; Piron, Lamberto

    2013-01-01

    Background. Haptic robots allow the exploitation of known motor learning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop, external communication, and graphic rendering for virtual reality) were implemented into a real-time MATLAB/Simulink environment, controlling a five-bar linkage able to provide forces up to 20 [N] at the end effector, used for finger and hand rehabilitation therapies. Clinical (i.e., Fugl-Meyer upper extremity scale; nine hold pegboard test) and kinematics (i.e., time; velocity; jerk metric; normalized jerk of standard movements) outcomes were assessed before and after treatment to detect changes in patients' motor performance. Reorganization of cortical activation was detected in one patient by fMRI. Results and Conclusions. All patients showed significant improvements in both clinical and kinematic outcomes. Additionally, fMRI results suggest that the proposed approach may promote a better cortical activation in the brain.

  11. Impact of 3 Tesla MRI on interobserver agreement in clinically isolated syndrome: A MAGNIMS multicentre study.

    Science.gov (United States)

    Hagens, Marloes Hj; Burggraaff, Jessica; Kilsdonk, Iris D; Ruggieri, Serena; Collorone, Sara; Cortese, Rosa; Cawley, Niamh; Sbardella, Emilia; Andelova, Michaela; Amann, Michael; Lieb, Johanna M; Pantano, Patrizia; Lissenberg-Witte, Birgit I; Killestein, Joep; Oreja-Guevara, Celia; Wuerfel, Jens; Ciccarelli, Olga; Gasperini, Claudio; Lukas, Carsten; Rovira, Alex; Barkhof, Frederik; Wattjes, Mike P

    2018-01-01

    Compared to 1.5 T, 3 T magnetic resonance imaging (MRI) increases signal-to-noise ratio leading to improved image quality. However, its clinical relevance in clinically isolated syndrome suggestive of multiple sclerosis remains uncertain. The purpose of this study was to investigate how 3 T MRI affects the agreement between raters on lesion detection and diagnosis. We selected 30 patients and 10 healthy controls from our ongoing prospective multicentre cohort. All subjects received baseline 1.5 and 3 T brain and spinal cord MRI. Patients also received follow-up brain MRI at 3-6 months. Four experienced neuroradiologists and four less-experienced raters scored the number of lesions per anatomical region and determined dissemination in space and time (McDonald 2010). In controls, the mean number of lesions per rater was 0.16 at 1.5 T and 0.38 at 3 T ( p = 0.005). For patients, this was 4.18 and 4.40, respectively ( p = 0.657). Inter-rater agreement on involvement per anatomical region and dissemination in space and time was moderate to good for both field strengths. 3 T slightly improved agreement between experienced raters, but slightly decreased agreement between less-experienced raters. Overall, the interobserver agreement was moderate to good. 3 T appears to improve the reading for experienced readers, underlining the benefit of additional training.

  12. Problem-solving ability and repetition of deliberate self-harm: a multicentre study.

    Science.gov (United States)

    McAuliffe, Carmel; Corcoran, Paul; Keeley, Helen S; Arensman, Ella; Bille-Brahe, Unni; De Leo, Diego; Fekete, Sandor; Hawton, Keith; Hjelmeland, Heidi; Kelleher, Margaret; Kerkhof, Ad J F M; Lönnqvist, Jouko; Michel, Konrad; Salander-Renberg, Ellinor; Schmidtke, Armin; Van Heeringen, Kees; Wasserman, Danuta

    2006-01-01

    While recent studies have found problem-solving impairments in individuals who engage in deliberate self-harm (DSH), few studies have examined repeaters and non-repeaters separately. The aim of the present study was to investigate whether specific types of problem-solving are associated with repeated DSH. As part of the WHO/EURO Multicentre Study on Suicidal Behaviour, 836 medically treated DSH patients (59% repeaters) from 12 European regions were interviewed using the European Parasuicide Study Interview Schedule (EPSIS II) approximately 1 year after their index episode. The Utrecht Coping List (UCL) assessed habitual responses to problems. Factor analysis identified five dimensions--Active Handling, Passive-Avoidance, Problem Sharing, Palliative Reactions and Negative Expression. Passive-Avoidance--characterized by a pre-occupation with problems, feeling unable to do anything, worrying about the past and taking a gloomy view of the situation, a greater likelihood of giving in so as to avoid difficult situations, the tendency to resign oneself to the situation, and to try to avoid problems--was the problem-solving dimension most strongly associated with repetition, although this association was attenuated by self-esteem. The outcomes of the study indicate that treatments for DSH patients with repeated episodes should include problem-solving interventions. The observed passivity and avoidance of problems (coupled with low self-esteem) associated with repetition suggests that intensive therapeutic input and follow-up are required for those with repeated DSH.

  13. Multicentre validation of IMRT pre-treatment verification: comparison of in-house and external audit.

    Science.gov (United States)

    Jornet, Núria; Carrasco, Pablo; Beltrán, Mercè; Calvo, Juan Francisco; Escudé, Lluís; Hernández, Victor; Quera, Jaume; Sáez, Jordi

    2014-09-01

    We performed a multicentre intercomparison of IMRT optimisation and dose planning and IMRT pre-treatment verification methods and results. The aims were to check consistency between dose plans and to validate whether in-house pre-treatment verification results agreed with those of an external audit. Participating centres used two mock cases (prostate and head and neck) for the intercomparison and audit. Compliance to dosimetric goals and total number of MU per plan were collected. A simple quality index to compare the different plans was proposed. We compared gamma index pass rates using the centre's equipment and methodology to those of an external audit. While for the prostate case, all centres fulfilled the dosimetric goals and plan quality was homogeneous, that was not the case for the head and neck case. The number of MU did not correlate with the plan quality index. Pre-treatment verifications results of the external audit did not agree with those of the in-house measurements for two centres: being within tolerance for in-house measurements and unacceptable for the audit or the other way round. Although all plans fulfilled dosimetric constraints, plan quality is highly dependent on the planner expertise. External audits are an excellent tool to detect errors in IMRT implementation and cannot be replaced by intercomparison using results obtained by centres. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  14. A prospective naturalistic multicentre study of intravenous medications in behavioural emergencies: haloperidol versus flunitrazepam.

    Science.gov (United States)

    Hatta, Kotaro; Nakamura, Mitsuru; Yoshida, Kenichi; Hamakawa, Hiroshi; Wakejima, Toru; Nishimura, Takao; Furuta, Ko; Kawabata, Toshitaka; Hirata, Toyoaki; Usui, Chie; Nakamura, Hiroyuki; Sawa, Yutaka

    2010-06-30

    A prospective naturalistic multicentre study for deep sedation was conducted in intensive care with continuous electrocardiogram (ECG) monitoring. Clinical purpose was enough sedation, which made uncooperative and disrupted patients receive brain computed tomography (CT), magnetic resonance imaging (MRI), or fluid therapy, with minimum drug doses. A first infusion was either haloperidol (HAL group) or flunitrazepam (FNP group). If enough sedation was not achieved, a second infusion, which was the opposite drug to the first infusion, was given. The proportion requiring a second infusion was higher in the HAL group than in the FNP group (82% vs. 36%, PFNP first group (FNP+HAL group) than the HAL first group (HAL+FNP group) (68% [S.D. 17] vs. 54% [S.D. 31], P=0.02). The mean dose of flunitrazepam in the HAL+FNP group was significantly lower than that in the FNP+HAL-group (1.3 mg vs. 3.5 mg, P=0.0003). Thus, in terms of monotherapy and speed of action, flunitrazepam has advantages over haloperidol as a first infusion for deep sedation. Regarding drug dosages, haloperidol has an advantage over flunitrazepam as a first infusion in safety.

  15. The effectiveness of 2-implant overdentures - a pragmatic international multicentre study.

    LENUS (Irish Health Repository)

    Rashid, F

    2011-03-01

    The purpose of this multicentre observational study was to determine patient satisfaction with either conventional dentures or mandibular 2-implant overdentures in a \\'real world\\' setting. Two hundred and three edentulous patients (mean age 68·8 ± 10·4 years) were recruited at eight centres located in North America, South America and Europe. The patients were provided with new mandibular conventional dentures or implant overdentures supported by two implants and ball attachments. At baseline and at 6 months post-treatment, they rated their satisfaction with their mandibular prostheses on 100-mm visual analogue scale questionnaires. One hundred and two (50·2%) participants had valid baseline and 6-month satisfaction data. Although both groups reported improvements, the implant overdenture group reported significantly higher ratings of overall satisfaction, comfort, stability, ability to speak and ability to chew. These results suggest that edentulous patients who choose mandibular implant overdentures have significantly greater improvements in satisfaction, despite their relatively higher cost, than those who choose new conventional dentures.

  16. Multicentre prospective evaluation of implant-assisted mandibular bilateral distal extension removable partial dentures: patient satisfaction.

    Science.gov (United States)

    Wismeijer, Daniel; Tawse-Smith, Andrew; Payne, Alan G T

    2013-01-01

    To compare the levels of patient satisfaction with either conventional mandibular bilateral distal extension partial dentures or those assisted by bilateral distal implants. Forty-eight participants who were dissatisfied with their existing conventional mandibular distal extension dentures opposing complete maxillary dentures were selected for a multicentre prospective study in New Zealand, Colombia and the Netherlands. A control group of 12 participants in New Zealand received conventional mandibular partial dentures. Three test groups involving 36 participants in New Zealand (12), Colombia (12) and the Netherlands (12) received bilateral distal implants in the second molar regions. After conventional loading, the test group participants initially had healing caps placed on the distal implants providing support only, followed after approximately 6 months by ball abutments (retentive anchors) for support and retention. Patient outcomes were determined with questionnaires completed at specific stages of the study for up to 3 years. Visual analogue scale, Likert and oral health impact questionnaires before and after treatment indicated improved results. There were significantly improved parameters of overall satisfaction, stability, chewing and appearance after 3 years (P removable partial dentures are a preferable treatment option for patients with complaints about their conventional distal extension partial dentures. © 2011 John Wiley & Sons A/S.

  17. Multicentre observational study of the natural history of left-sided acute diverticulitis.

    Science.gov (United States)

    Binda, G A; Arezzo, A; Serventi, A; Bonelli, L; Facchini, M; Prandi, M; Carraro, P S; Reitano, M C; Clerico, G; Garibotto, L; Aloesio, R; Sganzaroli, A; Zanoni, M; Zanandrea, G; Pellegrini, F; Mancini, S; Amato, A; Barisone, P; Bottini, C; Altomare, D F; Milito, G

    2012-02-01

    The natural history of acute diverticulitis (AD) is still unclear. This study investigated the recurrence rate, and the risks of emergency surgery, associated stoma and death following initial medical or surgical treatment of AD. The Italian Study Group on Complicated Diverticulosis conducted a 4-year multicentre retrospective and prospective database analysis of patients admitted to hospital for medical or surgical treatment of AD and then followed for a minimum of 9 years. The persistence of symptoms, recurrent episodes of AD, new hospital admissions, medical or surgical treatment, and their outcome were recorded during follow-up. Of 1046 patients enrolled at 17 centres, 743 were eligible for the study (407 recruited retrospectively and 336 prospectively); 242 patients (32·6 per cent) underwent emergency surgery at accrual. After a mean follow-up of 10·7 years, rates of recurrence (17·2 versus 5·8 per cent; P recurrence. There was no association between any of the investigated parameters and subsequent emergency surgery. The risk of stoma formation was below 1 per cent and disease-related mortality was zero in this group. The disease-related mortality rate was 0·6 per cent among patients who had surgical treatment. Long-term risks of recurrent AD or emergency surgery were limited and colectomy did not fully protect against recurrence. Copyright © 2011 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

  18. Haptic-Based Neurorehabilitation in Poststroke Patients: A Feasibility Prospective Multicentre Trial for Robotics Hand Rehabilitation

    Science.gov (United States)

    Daud Albasini, Omar A.; Oboe, Roberto; Tonin, Paolo; Paolucci, Stefano; Sandrini, Giorgio; Piron, Lamberto

    2013-01-01

    Background. Haptic robots allow the exploitation of known motor learning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop, external communication, and graphic rendering for virtual reality) were implemented into a real-time MATLAB/Simulink environment, controlling a five-bar linkage able to provide forces up to 20 [N] at the end effector, used for finger and hand rehabilitation therapies. Clinical (i.e., Fugl-Meyer upper extremity scale; nine hold pegboard test) and kinematics (i.e., time; velocity; jerk metric; normalized jerk of standard movements) outcomes were assessed before and after treatment to detect changes in patients' motor performance. Reorganization of cortical activation was detected in one patient by fMRI. Results and Conclusions. All patients showed significant improvements in both clinical and kinematic outcomes. Additionally, fMRI results suggest that the proposed approach may promote a better cortical activation in the brain. PMID:24319496

  19. Cross sectional survey of multicentre clinical databases in the United Kingdom

    Science.gov (United States)

    Black, Nick; Barker, Marian; Payne, Mary

    2004-01-01

    Objectives To describe the multicentre clinical databases that exist in the United Kingdom, to report on their quality, to explore which organisational and managerial features are associated with high quality, and to make recommendations for improvements. Design Cross sectional survey, with interviews with database custodians and search of electronic bibliographic database (PubMed). Studies reviewed 105 clinical databases across the United Kingdom. Results Clinical databases existed in all areas of health care, but their distribution was uneven—cancer and surgery were better covered than mental health and obstetrics. They varied greatly in age, size, growth rate, and geographical areas covered. Their scope (and thus their potential uses) and the quality of the data collected also varied. The latter was not associated with any organisational characteristics. Despite impressive achievements, many faced substantial financial uncertainty. Considerable scope existed for improvements: greater use of nationally approved codes; more support from relevant professional organisations; greater involvement by nurses, allied health professionals, managers, and laypeople in database management teams; and more attention to data security and ensuring patient confidentiality. With some notable exceptions, the audit and research potential of most databases had not been realised: half the databases had each produced only four or fewer peer reviewed research articles. Conclusions At least one clinical database support unit is needed in the United Kingdom to provide assistance in organisation and management, information technology, epidemiology, and statistics. Without such an initiative, the variable picture of databases reported here is likely to persist and their potential not be realised. PMID:15205292

  20. Making a successful return to work: the UK burden of injury multicentre longitudinal study

    Science.gov (United States)

    Kendrick, Denise; Vinogradova, Yana; Coupland, Carol; Christie, Nicola; Lyons, Ronan A; Towner, Elizabeth

    2012-01-01

    Background Injuries are common and make a significant contribution to sickness absence, but little is known about problems experienced by injured people on return to work (RTW). Aim To quantify work problems on RTW and explore predictors of such problems. Design & setting Multicentre longitudinal study in four UK hospitals. Method Prospective study of injured participants aged 16–65 years who were employed or self-employed prior to the injury and had RTW at 1 or 4 months post injury. Results At 1 month, most (59%) had only made a partial RTW. By 4 months, 80% had fully RTW. Those who had partially RTW had problems related to physical tasks (work limited for median of 25% of time at 1 month, 18% at 4 months), time management (10% at 1 month, 20% at 4 months) and output demands (10% at 1 month, 15% at 4 months). Productivity losses were significantly greater among those with partial than full RTW at 1 month (median 3.3% versus 0.9%, Pproblems and GPs should pay particular attention to identifying work problems in this group and ways of minimising such problems. PMID:22520774

  1. Evaluation of the preliminary auditory profile test battery in an international multi-centre study.

    Science.gov (United States)

    van Esch, Thamar E M; Kollmeier, Birger; Vormann, Matthias; Lyzenga, Johannes; Houtgast, Tammo; Hällgren, Mathias; Larsby, Birgitta; Athalye, Sheetal P; Lutman, Mark E; Dreschler, Wouter A

    2013-05-01

    This paper describes the composition and international multi-centre evaluation of a battery of tests termed the preliminary auditory profile. It includes measures of loudness perception, listening effort, speech perception, spectral and temporal resolution, spatial hearing, self-reported disability and handicap, and cognition. Clinical applicability and comparability across different centres are investigated. Headphone tests were conducted in five centres divided over four countries. Effects of test-retest, ear, and centre were investigated. Results for normally-hearing (NH) and hearing-impaired (HI) listeners are presented. Thirty NH listeners aged 19-39 years, and 72 HI listeners aged 22-91 years with a broad range of hearing losses were included. Test-retest reliability was generally good and there were very few right/left ear effects. Results of all tests were comparable across centres for NH listeners after baseline correction to account for necessary differences between test materials. For HI listeners, results were comparable across centres for the language-independent tests. The auditory profile forms a clinical test battery that is applicable in four different languages. Even after baseline correction, differences between test materials have to be taken into account when interpreting results of language-dependent tests in HI listeners.

  2. Computed tomography versus invasive coronary angiography: design and methods of the pragmatic randomised multicentre DISCHARGE trial

    Energy Technology Data Exchange (ETDEWEB)

    Napp, Adriane E.; Haase, Robert; Schuetz, Georg M.; Rief, Matthias; Katzer, Christoph; Dewey, Marc [Charite - Universitaetsmedizin Berlin, Department of Radiology, Berlin (Germany); Laule, Michael; Dreger, Henryk [Charite - Universitaetsmedizin Berlin, Department of Cardiology, Berlin (Germany); Feuchtner, Gudrun [Medical University Innsbruck, Department of Radiology, Innsbruck (Austria); Friedrich, Guy [Medical University Innsbruck, Department of Cardiology, Innsbruck (Austria); Spacek, Miloslav [University Hospital Motol, Department of Cardiology, Prague (Czech Republic); Suchanek, Vojtech [University Hospital Motol, Department of Radiology, Prague (Czech Republic); Fuglsang Kofoed, Klaus [Rigshospitalet Region Hovedstaden, Department of Radiology and Department of Cardiology, Copenhagen (Denmark); Engstroem, Thomas [Rigshospitalet Region Hovedstaden, Department of Cardiology, Copenhagen (Denmark); Schroeder, Stephen; Drosch, Tanja [ALB FILS KLINIKEN GmbH, Department of Cardiology, Goeppingen (Germany); Gutberlet, Matthias [University of Leipzig Heart Centre, Department of Radiology, Leipzig (Germany); Woinke, Michael [University of Leipzig Heart Centre, Department of Cardiology, Leipzig (Germany); Maurovich-Horvat, Pal; Merkely, Bela [Semmelweis University, MTA-SE Cardiovascular Imaging Center, Heart and Vascular Center, Budapest (Hungary); Donnelly, Patrick [Southeastern Health and Social Care Trust, Department of Cardiology, Belfast (United Kingdom); Ball, Peter [Southeastern Health and Social Care Trust, Department of Radiology, Belfast (United Kingdom); Dodd, Jonathan D. [St. Vincent' s University Hospital and National University of Ireland, Department of Radiology, Dublin (Ireland); Quinn, Martin [St. Vincent' s University Hospital, Department of Cardiology, Dublin (Ireland); Saba, Luca [Azienda Ospedaliero Universitaria di Cagliari, Department of Radiology, Monserrato (Italy); Porcu, Maurizio [Azienda Ospedaliera Brotzu, Department of Cardiology, Cagliari (Italy); Francone, Marco [Sapienza University of Rome, Department of Radiology, Rome (Italy); Mancone, Massimo [Sapienza University of Rome, Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology and Geriatric Sciences, Rome (Italy); Erglis, Andrejs [Paul Stradins Clinical University Hospital, Department of Cardiology, Riga (Latvia); Zvaigzne, Ligita [Paul Stradins Clinical University Hospital, Department of Radiology, Riga (Latvia); Jankauskas, Antanas [Lithuanian University of Health Sciences, Department of Radiology, Kaunas (Lithuania); Sakalyte, Gintare [Lithuanian University of Health Sciences, Department of Cardiology, Kaunas (Lithuania); Haran, Tomasz [Wojewodzki Szpital Specjalistyczny We Wroclawiu, Department of Radiology, Wroclaw (Poland); Ilnicka-Suckiel, Malgorzata [Wojewodzki Szpital Specjalistyczny We Wroclawiu, Department of Cardiology, Wroclaw (Poland); Bettencourt, Nuno; Gama-Ribeiro, Vasco [Centro Hospitalar de Vila Nova de Gaia, Department of Cardiology, Vila Nova de Gaia (Portugal); Condrea, Sebastian; Benedek, Imre [Cardio Med Medical Center, Department of Cardiology, Targu-Mures (Romania); Cemerlic Adjic, Nada [Institute of Cardiovascular Diseases of Vojvodina, Department of Cardiology, Novi Sad, Sremska Kamenica (Serbia); Adjic, Oto [Institute of Cardiovascular Diseases of Vojvodina, Radiology Department Imaging Center, Novi Sad, Sremska Kamenica (Serbia); Rodriguez-Palomares, Jose; Garcia del Blanco, Bruno [Universitat Autonoma de Barcelona, Department of Cardiology (Barcelona Spain), Hospital Universitari Vall d' Hebron, Institut de Recerca (VHIR), Barcelona (ES); Roditi, Giles; Berry, Colin [University of Glasgow, Institute of Cardiovascular and Medical Sciences, Glasgow (GB); Davis, Gershan [Aintree University Hospital, Department of Cardiology, Liverpool (GB); Thwaite, Erica [Aintree University Hospital, Department of Radiology, Liverpool (GB); Knuuti, Juhani [Turku University Hospital and University of Turku, Turku PET Centre, Turku (FI); Pietilae, Mikko [Turku University Hospital, Heart Centre, Turku (FI); Kepka, Cezary [The Institute of Cardiology in Warsaw, Department of Radiology, Warsaw (PL); Kruk, Mariusz [The Institute of Cardiology in Warsaw, Department of Cardiology, Warsaw (PL); Vidakovic, Radosav; Neskovic, Aleksandar N. [Clinical Hospital Center Zemun, Department of Cardiology, Belgrade-Zemun (RS); Diez, Ignacio [Basurto University Hospital, Department of Cardiology, Bilbao (ES); Lecumberri, Inigo [Basurto University Hospital, Department of Radiology, Bilbao (ES); Geleijns, Jacob [Leiden University Medical Center, Department of Radiology, Leiden (NL); Kubiak, Christine [European Clinical Research Infrastructure Network (ECRIN-ERIC), Management Office, Paris (FR); Strenge-Hesse, Anke [University Cologne, European Clinical Research Infrastructure Network (ECRIN-ERIC), National ECRIN office/KKS Network, Cologne (DE); Do, The-Hoang; Froemel, Felix [Charite - Universitaetsmedizin Berlin, Clinical Coordinating Centre, Berlin (DE); Gutierrez-Ibarluzea, Inaki; Benguria-Arrate, Gaizka [Basque Office for Health Technology Assessment, Vitoria-Gasteiz (ES); Keiding, Hans [University of Copenhagen, Department of Economics, Department of Economics, Copenhagen (DK); Mueller-Nordhorn, Jacqueline; Rieckmann, Nina [Charite - Universitaetsmedizin Berlin, Institute of Public Health, Berlin (DE); Walther, Mario; Schlattmann, Peter [Jena University Hospital, Friedrich Schiller University Jena, Institute of Medical Statistics, Computer Sciences and Documentation, Jena (DE); Collaboration: The DISCHARGE Trial Group

    2017-07-15

    More than 3.5 million invasive coronary angiographies (ICA) are performed in Europe annually. Approximately 2 million of these invasive procedures might be reduced by noninvasive tests because no coronary intervention is performed. Computed tomography (CT) is the most accurate noninvasive test for detection and exclusion of coronary artery disease (CAD). To investigate the comparative effectiveness of CT and ICA, we designed the European pragmatic multicentre DISCHARGE trial funded by the 7th Framework Programme of the European Union (EC-GA 603266). In this trial, patients with a low-to-intermediate pretest probability (10-60 %) of suspected CAD and a clinical indication for ICA because of stable chest pain will be randomised in a 1-to-1 ratio to CT or ICA. CT and ICA findings guide subsequent management decisions by the local heart teams according to current evidence and European guidelines. Major adverse cardiovascular events (MACE) defined as cardiovascular death, myocardial infarction and stroke as a composite endpoint will be the primary outcome measure. Secondary and other outcomes include cost-effectiveness, radiation exposure, health-related quality of life (HRQoL), socioeconomic status, lifestyle, adverse events related to CT/ICA, and gender differences. The DISCHARGE trial will assess the comparative effectiveness of CT and ICA. (orig.)

  3. HPV and cofactors for invasive cervical cancer in Morocco: a multicentre case-control study.

    Science.gov (United States)

    Berraho, Mohamed; Amarti-Riffi, Afaf; El-Mzibri, Mohammed; Bezad, Rachid; Benjaafar, Noureddine; Benideer, Abdelatif; Matar, Noureddine; Qmichou, Zinab; Abda, Naima; Attaleb, Mohammed; Znati, Kaoutar; El Fatemi, Hind; Bendahhou, Karima; Obtel, Majdouline; Filali Adib, Abdelhai; Mathoulin-Pelissier, Simone; Nejjari, Chakib

    2017-06-20

    Limited national information is available in Morocco on the prevalence and distribution of HPV-sub-types of cervical cancer and the role of other risk factors. The aim was to determine the frequency of HPV-sub-types of cervical cancer in Morocco and investigate risk factors for this disease. Between November 2009 and April 2012 a multicentre case-control study was carried out. A total of 144 cases of cervical cancer and 288 age-matched controls were included. Odds-ratios and corresponding confidence-intervals were computed by conditional logistic regression models. Current HPV infection was detected in 92.5% of cases and 13.9% of controls. HPV16 was the most common type for both cases and controls. Very strong associations between HPV-sub-types and cervical cancer were observed: total-HPV (OR = 39), HPV16 (OR = 49), HPV18 (OR = 31), and multiple infections (OR = 13). Education, high parity, sexual intercourse during menstruation, history of sexually transmitted infections, and husband's multiple sexual partners were also significantly associated with cervical cancer in the multivariate analysis. Our results could be used to establish a primary prevention program and to prioritize limited screening to women who have specific characteristics that may put them at an increased risk of cervical cancer.

  4. Coping strategies for postpartum depression: a multi-centric study of 1626 women.

    Science.gov (United States)

    Gutiérrez-Zotes, Alfonso; Labad, Javier; Martín-Santos, Rocío; García-Esteve, Luisa; Gelabert, Estel; Jover, Manuel; Guillamat, Roser; Mayoral, Fermín; Gornemann, Isolde; Canellas, Francesca; Gratacós, Mónica; Guitart, Montserrat; Roca, Miguel; Costas, Javier; Ivorra, Jose Luis; Navinés, Ricard; de Diego-Otero, Yolanda; Vilella, Elisabet; Sanjuan, Julio

    2016-06-01

    The transition to motherhood is stressful as it requires several important changes in family dynamics, finances, and working life, along with physical and psychological adjustments. This study aimed at determining whether some forms of coping might predict postpartum depressive symptomatology. A total of 1626 pregnant women participated in a multi-centric longitudinal study. Different evaluations were performed 8 and 32 weeks after delivery. Depression was assessed using the Edinburgh Postnatal Depression Scale (EPDS) and the structured Diagnostic Interview for Genetic Studies (DIGS). The brief Coping Orientation for Problem Experiences (COPE) scale was used to measure coping strategies 2-3 days postpartum. Some coping strategies differentiate between women with and without postpartum depression. A logistic regression analysis was used to explore the relationships between the predictors of coping strategies and major depression (according to DSM-IV criteria). In this model, the predictor variables during the first 32 weeks were self-distraction (OR 1.18, 95 % CI 1.04-1.33), substance use (OR 0.58, 95 % CI 0.35-0.97), and self-blame (OR 1.18, 95 % CI 1.04-1.34). In healthy women with no psychiatric history, some passive coping strategies, both cognitive and behavioral, are predictors of depressive symptoms and postpartum depression and help differentiate between patients with and without depression.

  5. Evidence - competence - discourse: the theoretical framework of the multi-centre clinical ethics support project METAP.

    Science.gov (United States)

    Reiter-Theil, Stella; Mertz, Marcel; Schürmann, Jan; Stingelin Giles, Nicola; Meyer-Zehnder, Barbara

    2011-09-01

    In this paper we assume that 'theory' is important for Clinical Ethics Support Services (CESS). We will argue that the underlying implicit theory should be reflected. Moreover, we suggest that the theoretical components on which any clinical ethics support (CES) relies should be explicitly articulated in order to enhance the quality of CES. A theoretical framework appropriate for CES will be necessarily complex and should include ethical (both descriptive and normative), metaethical and organizational components. The various forms of CES that exist in North-America and in Europe show their underlying theory more or less explicitly, with most of them referring to some kind of theoretical components including 'how-to' questions (methodology), organizational issues (implementation), problem analysis (phenomenology or typology of problems), and related ethical issues such as end-of-life decisions (major ethical topics). In order to illustrate and explain the theoretical framework that we are suggesting for our own CES project METAP, we will outline this project which has been established in a multi-centre context in several healthcare institutions. We conceptualize three 'pillars' as the major components of our theoretical framework: (1) evidence, (2) competence, and (3) discourse. As a whole, the framework is aimed at developing a foundation of our CES project METAP. We conclude that this specific integration of theoretical components is a promising model for the fruitful further development of CES. © 2011 Blackwell Publishing Ltd.

  6. L-Carnitine-supplementation in advanced pancreatic cancer (CARPAN - a randomized multicentre trial

    Directory of Open Access Journals (Sweden)

    Kraft Matthias

    2012-07-01

    Full Text Available Abstract Background Cachexia, a >10% loss of body-weight, is one factor determining the poor prognosis of pancreatic cancer. Deficiency of L-Carnitine has been proposed to cause cancer cachexia. Findings We screened 152 and enrolled 72 patients suffering from advanced pancreatic cancer in a prospective, multi-centre, placebo-controlled, randomized and double-blinded trial to receive oral L-Carnitine (4 g or placebo for 12 weeks. At entry patients reported a mean weight loss of 12 ± 2,5 (SEM kg. During treatment body-mass-index increased by 3,4 ± 1,4% under L-Carnitine and decreased (−1,5 ± 1,4% in controls (p  Conclusion While these data are preliminary and need confirmation they indicate that patients with pancreatic cancer may have a clinically relevant benefit from the inexpensive and well tolerated oral supplementation of L-Carnitine.

  7. Re-dislocation after revision total hip arthroplasty for recurrent dislocation: a multicentre study.

    Science.gov (United States)

    Yoshimoto, Kensei; Nakashima, Yasuharu; Aota, Shigeo; Kaneuji, Ayumi; Fukui, Kiyokazu; Hirakawa, Kazuo; Nakura, Nariaki; Kinoshita, Koichi; Naito, Masatoshi; Iwamoto, Yukihide

    2017-02-01

    Although most case of dislocations after total hip arthroplasty (THA) can be managed with conservative treatment, recurrent dislocation may require surgical intervention. This multicentre study was conducted to evaluate the re-dislocation rate after revision THA for recurrent dislocation, and to determine the risk factors for re-dislocation. We retrospectively reviewed the 88 hips in 88 patients who underwent revision THA for recurrent dislocation at five institutions between 1995 and 2014. The mean patient age at surgery was 68.5 years and the mean follow-up period was 53.1 months. Multivariate logistic regression was performed to identify risk factors for re-dislocation. Sixteen hips in 16 patients (18.2 %) re-dislocated at a mean of 25.5 months (range, 1-83 months) after revision THA. Multivariate analysis identified osteonecrosis of the femoral head (odds ratio [OR] = 5.62 vs. osteoarthritis) and a femoral head size hips required additional revision THA for re-dislocation. The re-dislocation rate after revision THA for recurrent dislocation remains high, suggesting the need for prevention measures. We recommend the use of a femoral head size ≥ 32 mm.

  8. Prospective Multicentre Study on the Epidemiology and Current Therapeutic Management of Severe Bronchiolitis in Spain

    Directory of Open Access Journals (Sweden)

    Jose C. Flores-González

    2017-01-01

    Full Text Available Objective. To determine the epidemiology and therapeutic management of patients with severe acute bronchiolitis (AB admitted to paediatric intensive care units (PICUs in Spain. Design. Descriptive, prospective, multicentre study. Setting. Sixteen Spanish PICUs. Patients. Patients with severe AB who required admission to any of the participating PICUs over 1 year. Interventions. Both epidemiological variables and medical treatment received were recorded. Results. A total of 262 patients were recruited; 143 were male (54.6%, with median age of 1 month (0–23. Median stay in the PICU was 7 days (1–46. Sixty patients (23% received no nebuliser treatment, while the rest received a combination of inhalation therapies. One-quarter of patients (24.8% received corticosteroids and 56.5% antibiotic therapy. High-flow oxygen therapy was used in 14.3% and noninvasive ventilation (NIV was used in 75.6%. Endotracheal intubation was required in 24.4% of patients. Younger age, antibiotic therapy, and invasive mechanical ventilation (IMV were risk factors that significantly increased the stay in the PICU. Conclusions. Spanish PICUs continue to routinely use nebulised bronchodilator treatment and corticosteroid therapy. Despite NIV being widely used in this condition, intubation was required in one-quarter of cases. Younger age, antibiotic therapy, and IMV were associated with a longer stay in the PICU.

  9. Variability in drug use among newborns admitted to NICUs: a proposal for a European multicentre study

    Directory of Open Access Journals (Sweden)

    Laura Cuzzolin

    2014-01-01

    Full Text Available The use of drugs in newborns admitted to NICUs is characterized by a great variability. This widespread phenomenon, observed both within and between different countries, has been highlighted by reporting data on the treatment of neonatal sepsis and PDA throughout Europe: the dosages and the intervals between administrations of ciprofloxacin and fluconazole varied significantly and a wide variation was also observed as regards the use of NSAIDs to treat PDA. Given the unique characteristics of the neonatal population, the use of drugs on an individual basis could be sometimes justified. However, other factors such as the lack of evidence-based guidelines and the common use of drugs in an off-label manner (more than 80% of newborns receive this kind of treatment could contribute to the variability in medicine use, making the neonatal population vulnerable to adverse drug reactions (ADRs and medication errors: the potential ADRs rate, 3 times higher in pediatric wards, is more significantly higher in NICUs and the frequency of medication errors (mostly dose errors widely exceeds the medium value. The differences in clinical practices observed between NICUs need to be addressed at a European level and a multicentre study could be useful to harmonize drug use in newborns.

  10. Perspectives of Cosmesis following Breast Conservation for Multifocal and Multicentric Breast Cancers

    Directory of Open Access Journals (Sweden)

    Mona P. Tan

    2015-01-01

    Full Text Available Background. Contemporary data suggest that breast conservation treatment (BCT for multifocal and multicentric breast cancer (MFMCBC may be appropriate with noninferior local control rates. However, there is a paucity of data to evaluate patient’s satisfaction with cosmetic outcomes after BCT for MFMCBC. This study was performed to bridge this information gap. Methods. All patients treated at the authors’ healthcare facility were included in the study. Patients with MFMCBC who were assessed to be eligible for BCT underwent tumour resection using standard surgical techniques with direct parenchymal closure through a single incision. After at least three years of follow-up, they were invited to participate in a survey regarding their cosmetic outcomes. Results. Of a total of 160 patients, 40 had MFMCBC, of whom 34 (85% underwent successful BCT. Five-year cancer-specific survival and disease-free survival were 95.7%. Twenty of the 34 patients responded to the survey. No patient rated her cosmetic outcome as “poor.” Analysis indicated low agreement between patients’ self-assessment and clinician-directed evaluation of aesthetic results. Conclusion. BCT for MFMCBC is feasible with acceptable survival and cosmetic outcomes. However, there appears to be a disparity between patient and clinician-directed evaluation of cosmetic results which warrant further research.

  11. Atypical presentation of multicentric Castleman disease in a pediatric patient: pleural and pericardial effusion.

    Science.gov (United States)

    Akman, Alkim Oden; Basaran, Ozge; Ozyoruk, Derya; Han, Unsal; Sayli, Tulin; Cakar, Nilgun

    2016-06-01

    Castleman disease (CD) is a rare poorly understood lymphoproliferative disorder. Pediatric onset CD has been reported before. However, most of them have benign unicentric pattern. Multicentric CD (MCD) is quite rare in children. Herein, we report a 13-year-old adolescent boy with MCD of the hyaline vascular variant presenting with pleural and pericardial effusion, which is an uncommon presentation. MCD should be considered in the differential diagnosis of pleural and/or pericardial effusion with unexplained lymph nodes in children. What is Known •Pediatric Castleman disease (CD) most commonly occurs in the unicentric form, which typically is asymptomatic and cured by lymph node excision. •The diagnosis of MCD can be difficult owing to the heterogeneity of presentation and potential for nonspecific multisystem involvement. What is New •A 13-year-old adolescent boy was diagnosed with MCD of the hyaline vascular variant presenting with pleural and pericardial effusion, which is an uncommon presentation. •In a pediatric patient with fever, pleural-pericardial effusion and multiple lymph nodes, MCD should be considered in differantial diagnosis.

  12. Performance of mechanical ventilators at the patient's home: a multicentre quality control study.

    Science.gov (United States)

    Farré, R; Navajas, D; Prats, E; Marti, S; Guell, R; Montserrat, J M; Tebe, C; Escarrabill, J

    2006-05-01

    Quality control procedures vary considerably among the providers of equipment for home mechanical ventilation (HMV). A multicentre quality control survey of HMV was performed at the home of 300 patients included in the HMV programmes of four hospitals in Barcelona. It consisted of three steps: (1) the prescribed ventilation settings, the actual settings in the ventilator control panel, and the actual performance of the ventilator measured at home were compared; (2) the different ventilator alarms were tested; and (3) the effect of differences between the prescribed settings and the actual performance of the ventilator on non-programmed readmissions of the patient was determined. Considerable differences were found between actual, set, and prescribed values of ventilator variables; these differences were similar in volume and pressure preset ventilators. The percentage of patients with a discrepancy between the prescribed and actual measured main ventilator variable (minute ventilation or inspiratory pressure) of more than 20% and 30% was 13% and 4%, respectively. The number of ventilators with built in alarms for power off, disconnection, or obstruction was 225, 280 and 157, respectively. These alarms did not work in two (0.9%), 52 (18.6%) and eight (5.1%) ventilators, respectively. The number of non-programmed hospital readmissions in the year before the study did not correlate with the index of ventilator error. This study illustrates the current limitations of the quality control of HMV and suggests that improvements should be made to ensure adequate ventilator settings and correct ventilator performance and ventilator alarm operation.

  13. The micronutrient intake profile of a multicentre cohort of Australian LAGB patients.

    Science.gov (United States)

    McGrice, Melanie A; Porter, Judi A

    2014-03-01

    Patients who have undergone bariatric surgery have increased risks of developing micronutrient deficiencies. Translational research investigating the actual micronutrient intake of bariatric patients is limited. We examined the micronutrient intake of a multicentre cohort of laparoscopic adjustable gastric banding patients 1 year post-surgery. These data were compared to micronutrient recommendations for the general population. Consecutive patients from three bariatric surgery facilities in Melbourne, Australia, were invited to participate 12 months post-operatively. A validated food frequency questionnaire was posted to 215 prospective participants. Of the 52 participants, micronutrient intakes from food and fluids alone were below population recommendations for calcium, folate, magnesium, potassium, retinol equivalents, thiamin and vitamin E. Males did not meet the recommended intakes for zinc, and iron intakes in pre-menopausal women were insufficient. Intakes lower than recommended levels for these micronutrients suggest inadequate intake of foods from vegetable, dairy, lean meat (or alternatives) and wholegrains. Micronutrient intakes below recommended levels in this patient group can be further explained by their macronutrient intakes that suggested diets of poor nutrient density. Recommendations for supplementation in this group have wide variations, usually having been developed through the presence of clinical and biochemical deficiencies. Nutritional supplementation should be more extensive in scope and dosage than is currently recommended by some professional guidelines. Further long-term studies are needed to explore both macro- and micronutrient intakes on the morbidity and mortality of this patient population.

  14. Diagnostic screening of paroxysmal nocturnal hemoglobinuria: Prospective multicentric evaluation of the current medical indications.

    Science.gov (United States)

    Morado, Marta; Freire Sandes, Alex; Colado, Enrique; Subirá, Dolores; Isusi, Paloma; Soledad Noya, María; Belén Vidriales, María; Sempere, Amparo; Ángel Díaz, José; Minguela, Alfredo; Álvarez, Beatriz; Serrano, Cristina; Caballero, Teresa; Rey, Mercedes; Pérez Corral, Ana; Cristina Fernández Jiménez, María; Magro, Elena; Lemes, Angelina; Benavente, Celina; Bañas, Helena; Merino, Juana; Castejon, Celine; Gutierrez, Olivier; Rabasa, Pilar; Vescosi Gonçalves, Matheus; Perez-Andres, Martin; Orfao, Alberto

    2017-09-01

    Although consensus guidelines have been proposed in 2010 for the diagnostic screening of paroxysmal nocturnal hemoglobinuria (PNH) by flow cytometry (FCM), so far no study has investigated the efficiency of such medical indications in multicentric vs. reference laboratory settings. Here we evaluate the efficiency of consensus medical indications for PNH testing in 3,938 peripheral blood samples submitted to FCM testing in 24 laboratories in Spain and one reference center in Brazil. Overall, diagnostic screening based on consensus medical indications was highly efficient (14% of PNH + samples) both in the multicenter setting in Spain (10%) and the reference laboratory in Brazil (16%). The highest frequency of PNH + cases was observed among patients screened because of bone marrow (BM) failure syndrome (33%), particularly among those with aplastic anemia (AA; 45%) and to a less extent also a myelodysplastic syndrome (MDS; 10%). Among the other individuals studied, the most efficient medical indications for PNH screening included: hemolytic anemia (19%), hemoglobinuria (48%) and unexplained cytopenias (9%). In contrast, only a minor fraction of the patients who had been submitted for PNH testing because of unexplained thrombosis in the absence of cytopenia, were positive (0.4%). In summary, our results demonstrate that the current medical indications for PNH screening by FCM are highly efficient, although improved screening algorithms are needed for patients presenting with thrombosis and normal blood cell counts. © 2016 International Clinical Cytometry Society. © 2016 International Clinical Cytometry Society.

  15. Copper T380A intrauterine device for emergency contraception: a prospective, multicentre, cohort clinical trial.

    Science.gov (United States)

    Wu, S; Godfrey, E M; Wojdyla, D; Dong, J; Cong, J; Wang, C; von Hertzen, H

    2010-09-01

    To determine the effectiveness of the Copper T380A (CuT380A) intrauterine device (IUD) as an emergency contraceptive in women. Prospective, multicentre, cohort clinical trial. Eighteen family planning clinics in China. A cohort of 1963 women, aged 18-44 years, requesting emergency contraception within 120 hours of unprotected sexual intercourse. Women requesting emergency contraception were followed at 1, 3 and 12 months after the insertion of CuT380A. Efficacy of CuT380A as emergency contraception and for up to 12 months of postinsertion use. Insertion complication rates, reported side-effects and continuation rates at 12 months were also recorded. No pregnancies occurred prior to or at the first follow-up visit, making CuT380A 100% effective as emergency contraception in this study. The pregnancy rate over the 12-month period was 0.23 per 100 women. In all, 29 (1.5%) women experienced a difficult IUD insertion process, requiring local anaesthesia or prophylactic antibiotics. No uterine perforations occurred. The main side-effects were increased menstrual bleeding and menstrual disturbances. The 12-month postinsertion continuation rate was 94.0 per 100 woman-years. CuT380A is a safe and effective method for emergency contraception. The advantages of CuT380A include its ability to provide effective, long-term contraception.

  16. Prospective Multicentre Study on the Epidemiology and Current Therapeutic Management of Severe Bronchiolitis in Spain

    Science.gov (United States)

    Mayordomo-Colunga, Juan; Jordan, Iolanda; Miras-Veiga, Alicia; Montero-Valladares, Cristina; Olmedilla-Jodar, Marta; Alcaraz-Romero, Andrés J.; Eizmendi-Bereciartua, Miren; Fernández-Carrión, Francisco; Santiago-Gutierrez, Carmen; Aleo-Luján, Esther; Pérez-Quesada, Sonia; Yun-Castilla, Cristina; Martín, Carmen; Navarro-Mingorance, Álvaro; Goñi-Orayen, Concha

    2017-01-01

    Objective. To determine the epidemiology and therapeutic management of patients with severe acute bronchiolitis (AB) admitted to paediatric intensive care units (PICUs) in Spain. Design. Descriptive, prospective, multicentre study. Setting. Sixteen Spanish PICUs. Patients. Patients with severe AB who required admission to any of the participating PICUs over 1 year. Interventions. Both epidemiological variables and medical treatment received were recorded. Results. A total of 262 patients were recruited; 143 were male (54.6%), with median age of 1 month (0–23). Median stay in the PICU was 7 days (1–46). Sixty patients (23%) received no nebuliser treatment, while the rest received a combination of inhalation therapies. One-quarter of patients (24.8%) received corticosteroids and 56.5% antibiotic therapy. High-flow oxygen therapy was used in 14.3% and noninvasive ventilation (NIV) was used in 75.6%. Endotracheal intubation was required in 24.4% of patients. Younger age, antibiotic therapy, and invasive mechanical ventilation (IMV) were risk factors that significantly increased the stay in the PICU. Conclusions. Spanish PICUs continue to routinely use nebulised bronchodilator treatment and corticosteroid therapy. Despite NIV being widely used in this condition, intubation was required in one-quarter of cases. Younger age, antibiotic therapy, and IMV were associated with a longer stay in the PICU. PMID:28421191

  17. Chikungunya Infection in India: Results of a Prospective Hospital Based Multi-Centric Study

    Science.gov (United States)

    Ray, Pratima; Ratagiri, Vinod H.; Kabra, Sushil K.; Lodha, Rakesh; Sharma, Sumit; Sharma, B. S.; Kalaivani, Mani; Wig, Naveet

    2012-01-01

    Background Chikungunya (CHIKV) has recently seen a re-emergence in India with high morbidity. However, the epidemiology and disease burden remain largely undetermined. A prospective multi-centric study was conducted to evaluate clinical, epidemiological and virological features of chikugunya infection in patients with acute febrile illness from various geographical regions of India. Methods and Findings A total of 540 patients with fever of up to 7days duration were enrolled at Karnataka Institute of Medical Sciences (KIMS), Karnataka (South); Sawai Man Singh Medical College (SMS) Rajasthan (West), and All India Institute of Medical Sciences (AIIMS) New Delhi (North) from June 2008 to May 2009. Serum specimens were screened for chikungunya infection concurrently through RT-PCR and serology (IgM). Phylogenetic analysis was performed using Bioedit and Mega2 programs. Chikungunya infection was detected in 25.37% patients by RT-PCR and/or IgM-ELISA. Highest cases were detected in south (49.36%) followed by west (16.28%) and north (0.56%) India. A difference in proportion of positives by RT-PCR/ELISA with regard to duration of fever was observed (pchikungunya confirmed cases (pchikungunya in high frequencies and severe morbidity in south and west India but rare in north. The study emphasizes the need for continuous surveillance for disease burden using multiple diagnostic tests and also warrants the need for an appropriate molecular diagnostic for early detection of chikungunya virus. PMID:22363413

  18. Multicentre external validation of the BIMC model for solid solitary pulmonary nodule malignancy prediction

    Energy Technology Data Exchange (ETDEWEB)

    Soardi, Gian Alberto; Perandini, Simone; Motton, Massimiliano; Montemezzi, Stefania [AOUI Verona, UOC Radiologia, Ospedale Maggiore di Borgo Trento, Verona (Italy); Larici, Anna Rita; Del Ciello, Annemilia [Universita Cattolica del Sacro Cuore, Dipartimento di Scienze Radiologiche, Roma (Italy); Rizzardi, Giovanna [UO Chirurgia Toracica, Ospedale Humanitas Gavazzeni, Bergamo (Italy); Solazzo, Antonio [UO Radiologia, Ospedale Humanitas Gavazzeni, Bergamo (Italy); Mancino, Laura [UO Pneumologia, Ospedale dell' Angelo di Mestre, Mestre (Italy); Bernhart, Marco [UO Radiologia, Ospedale dell' Angelo di Mestre, Mestre (Italy)

    2017-05-15

    To provide multicentre external validation of the Bayesian Inference Malignancy Calculator (BIMC) model by assessing diagnostic accuracy in a cohort of solitary pulmonary nodules (SPNs) collected in a clinic-based setting. To assess model impact on SPN decision analysis and to compare findings with those obtained via the Mayo Clinic model. Clinical and imaging data were retrospectively collected from 200 patients from three centres. Accuracy was assessed by means of receiver-operating characteristic (ROC) areas under the curve (AUCs). Decision analysis was performed by adopting both the American College of Chest Physicians (ACCP) and the British Thoracic Society (BTS) risk thresholds. ROC analysis showed an AUC of 0.880 (95 % CI, 0.832-0.928) for the BIMC model and of 0.604 (95 % CI, 0.524-0.683) for the Mayo Clinic model. Difference was 0.276 (95 % CI, 0.190-0.363, P < 0.0001). Decision analysis showed a slightly reduced number of false-negative and false-positive results when using ACCP risk thresholds. The BIMC model proved to be an accurate tool when characterising SPNs. In a clinical setting it can distinguish malignancies from benign nodules with minimal errors by adopting current ACCP or BTS risk thresholds and guiding lesion-tailored diagnostic and interventional procedures during the work-up. (orig.)

  19. Current management of intracerebral haemorrhage in China: a national, multi-centre, hospital register study

    Directory of Open Access Journals (Sweden)

    Heeley Emma L

    2011-01-01

    Full Text Available Abstract Background We aimed to examine current practice of the management and secondary prevention of intracerebral haemorrhage (ICH in China where the disease is more common than in Western populations. Methods Data on baseline characteristics, management in-hospital and post-stroke, and outcome of ICH patients are from the ChinaQUEST (QUality Evaluation of Stroke Care and Treatment study, a multi-centre, prospective, 62 hospital registry in China during 2006-07. Results Nearly all ICH patients (n = 1572 received an intravenous haemodiluting agent such as mannitol (96% or a neuroprotectant (72%, and there was high use of intravenous traditional Chinese medicine (TCM (42%. Neurosurgery was undertaken in 137 (9% patients; being overweight, having a low Glasgow Coma Scale (GCS score on admission, and Total Anterior Circulation Syndrome (TACS clinical pattern on admission, were the only baseline factors associated with this intervention in multivariate analyses. Neurosurgery was associated with nearly three times higher risk of death/disability at 3 months post-stroke (odd ratio [OR] 2.60, p Conclusions The management of ICH in China is characterised by high rates of use of intravenous haemodiluting agents, neuroprotectants, and TCM, and of antihypertensives for secondary prevention. The controversial efficacy of these therapies, coupled with the current lack of treatments of proven benefit, is a call for action for more outcomes based research in ICH.

  20. Haptic-Based Neurorehabilitation in Poststroke Patients: A Feasibility Prospective Multicentre Trial for Robotics Hand Rehabilitation

    Directory of Open Access Journals (Sweden)

    Andrea Turolla

    2013-01-01

    Full Text Available Background. Haptic robots allow the exploitation of known motorlearning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop, external communication, and graphic rendering for virtual reality were implemented into a real-time MATLAB/Simulink environment, controlling a five-bar linkage able to provide forces up to 20 [N] at the end effector, used for finger and hand rehabilitation therapies. Clinical (i.e., Fugl-Meyer upper extremity scale; nine hold pegboard test and kinematics (i.e., time; velocity; jerk metric; normalized jerk of standard movements outcomes were assessed before and after treatment to detect changes in patients' motor performance. Reorganization of cortical activation was detected in one patient by fMRI. Results and Conclusions. All patients showed significant improvements in both clinical and kinematic outcomes. Additionally, fMRI results suggest that the proposed approach may promote a better cortical activation in the brain.

  1. Measuring patient-centredness, the neglected outcome in fertility care: a random multicentre validation study.

    Science.gov (United States)

    van Empel, Inge W H; Aarts, Johanna W M; Cohlen, Ben J; Huppelschoten, Dana A; Laven, Joop S E; Nelen, Willianne L D M; Kremer, Jan A M

    2010-10-01

    High-quality fertility care should be effective and safe, but also patient-centred. However, a suitable instrument for measuring patient-centredness is lacking. This study aims to develop and validate an instrument that can reliably measure patient-centredness in fertility care: patient-centredness questionnaire-infertility (PCQ-infertility). The PCQ's content, addressing 53 care aspects, was generated by seven focus groups with 54 infertile patients. Besides background questions, the questionnaire included one 'experience item' and one 'importance item' for each care aspect. Thirty Dutch fertility clinics were invited to participate in the validation study. The questionnaire was sent at random to 1200 infertile couples. Psychometric tests included inter-item and reliability analyses. Importance scores were calculated. The discriminative power was determined using multilevel analysis. The questionnaire was completed by 888 infertile couples (net response 75%) from 29 clinics. The ultimate PCQ-infertility, comprising 46 items and seven subscales, appeared reliable and valid for measuring patient-centredness in fertility care. Of the seven subscales, 'communication' received the best ratings and 'continuity' the worst. 'Honesty and clearness on what to expect from fertility care' appeared most important to patients. Significant differences between clinics were found, even after case-mix adjustment. This study resulted in a valid, reliable and strongly discriminating instrument for measuring patient-centredness in fertility care. The PCQ-infertility can identify shortcomings on patient-centredness and can be adopted for quality improvement. Therefore, fertility care can now be monitored and benchmarked on patient-centredness, as well as on live birth and complication rates.

  2. Randomized multicentre pilot study of sacubitril/valsartan versus irbesartan in patients with chronic kidney disease: United Kingdom Heart and Renal Protection (HARP)- III-rationale, trial design and baseline data.

    Science.gov (United States)

    2017-12-01

    Patients with chronic kidney disease (CKD) are at risk of progression to end-stage renal disease and cardiovascular disease. Data from other populations and animal experiments suggest that neprilysin inhibition (which augments the natriuretic peptide system) may reduce these risks, but clinical trials among patients with CKD are required to test this hypothesis. UK Heart and Renal Protection III (HARP-III) is a multicentre, double-blind, randomized controlled trial comparing sacubitril/valsartan 97/103 mg two times daily (an angiotensin receptor-neprilysin inhibitor) with irbesartan 300 mg one time daily among 414 patients with CKD. Patients ≥18 years of age with an estimated glomerular filtration rate (eGFR) of ≥45 but 20 mg/mmol or eGFR ≥20 but III will provide important information on the short-term effects of sacubitril/valsartan on renal function, tolerability and safety among patients with CKD.

  3. Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial

    DEFF Research Database (Denmark)

    Jespersen, Christian M; Als-Nielsen, Bodil; Damgaard, Morten

    2005-01-01

    OBJECTIVE: To determine if the macrolide clarithromycin affects mortality and cardiovascular morbidity in patients with stable coronary heart disease. DESIGN: Centrally randomised multicentre trial. All parties at all stages were blinded. Analyses were by intention to treat. SETTING: Five...... Copenhagen University cardiology departments and a coordinating centre. PARTICIPANTS: 13,702 patients aged 18 to 85 years who had a discharge diagnosis of myocardial infarction or angina pectoris in 1993-9 and alive in August 1999 were invited by letter; 4373 were randomised. INTERVENTIONS: Two weeks...

  4. Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial

    DEFF Research Database (Denmark)

    Jespersen, CM; Als-Nielsen, B; Damgaard, M

    2006-01-01

    OBJECTIVE: To determine if the macrolide clarithromycin affects mortality and cardiovascular morbidity in patients with stable coronary heart disease. DESIGN: Centrally randomised multicentre trial. All parties at all stages were blinded. Analyses were by intention to treat. SETTING: Five...... Copenhagen University cardiology departments and a coordinating centre. PARTICIPANTS: 13,702 patients aged 18 to 85 years who had a discharge diagnosis of myocardial infarction or angina pectoris in 1993-9 and alive in August 1999 were invited by letter; 4373 were randomised. INTERVENTIONS: Two weeks...

  5. Danazol treatment of benign breast disease: a survey of U.S.A. multi-centre studies.

    Science.gov (United States)

    Brookshaw, J D

    1979-01-01

    514 patients with benign breast disease provided records from multicentre studies in the U.S.A. Results showed that a high proportion responded with either decrease or elimination of symptoms, response usually being apparent 15 to 45 days after commencing treatment. Dosage schedules varied between 50 and 400 mg danazol daily and length of treatment between 15 and 196 days. There was a tendency for patients with more severe symptoms to respond better to the higher dosages, and for the elimination rate for all grades of severity to improve with time. Side effects were not severe, and of the expected type including weight gain, oiliness of skin and hair, and acne.

  6. Fast neutrons in the treatment of head and neck cancers: the results of a multi-centre randomly controlled trial

    International Nuclear Information System (INIS)

    Duncan, W.; Arnott, S.J.; Orr, J.A.; Kerr, G.R.; Schmitt, G.

    1984-01-01

    The results are presented of a multi-centre randomly controlled trial of fast neutron irradiation and mega-voltage X-rays in the treatment of patients with locally advanced squamous cell carcinoma of the head and neck region. No significant difference was observed in local tumour control rates. Salvage surgery was performed in a similar number of patients in the two groups. Late morbidity was also similar in the two treatment groups. Patients in a subgroup with cancer of the larynx treated by photons had a significantly better survival than those in the neutron treated group. (Auth.)

  7. Treatment of multicentric or cranial mediastinal high-grade T-cell lymphoma in dogs with a first-line CCNU-L(-chlorambucil)-CHOP protocol

    OpenAIRE

    Ossowska, M.; Teske, E.; Beirens-Van Kuijk, L.; Zandvliet, Maurice; De Vos, J. P.

    2016-01-01

    This retrospective study determined disease free survival (DFS) and progression free survival (PFS) in chemo-naïve dogs with multicentric or cranial mediastinal high-grade T-cell lymphoma, treated with a first-line CCNU-L(-chlorambucil)-CHOP protocol. Of thirteen dogs with multicentric lymphoma, 92.3% achieved a complete remission (CR), and the median DFS and PFS was 317 and 256 days, respectively. Three dogs had cranial mediastinal lymphoma, and achieved a CR with a median DFS and PFS of 978...

  8. Medical biomodelling in surgical applications: results of a multicentric European validation of 466 cases.

    Science.gov (United States)

    Wulf, J; Vitt, K D; Erben, C M; Bill, J S; Busch, L C

    2003-01-01

    The study started in September 1999 and ended in April 2002. It is based on a questionnaire [www.phidias.org] assessing case-related questions due to the application of stereolithographic models. Each questionnaire contains over 50 items. These variables take into account diagnosis, indications and benefits of stereolithographic models with view on different steps of the surgical procedures: preoperative planning, intraoperative application and overall outcome after surgical intervervention. These questionnaires were completed by the surgeons who performed operation. Over the time course of our multicentric study (30 months), we evaluated 466 cases. The study population consists of n=231 male and n= 235 female patients. 54 surgeons from 9 European countries were involved. There are main groups of diagnosis that related to the use of a model. Most models were used in maxillofacial surgery. The operative planning may help to determine the resection line of tumor and optimize reconstructive procedures. Correction of large calvarian defects can be simulated and implants can be produced preoperatively. Overall in 58 % of all cases a time- saving effect was reported. The study strongly suggests, that medical modeling has utility in surgical specialities, especially in the craniofacial and maxillofacial area, however increasingly in the orthopedic field. Due to our results, medical modeling optimizes the preoperative surgical planning. Surgeons are enabeled to perform realistic and interactive simulations. The fabrication of implants, its design and fit on the model, allow to reduce operation time and in consequence risk and cost of operation. In addition, the understanging of volumetric data is improved, especially if medical models are combined with standart imaging modalities. Finally, surgeons are able to improve communication between their patientents and colleagues.

  9. Results of collagen plug occlusion of anal fistula: a multicentre study of 126 patients.

    Science.gov (United States)

    Blom, J; Husberg-Sellberg, B; Lindelius, A; Gustafsson, U-M; Carlens, S; Oppelstrup, H; Bragmark, M; Yin, L; Nyström, P-O

    2014-08-01

    The Biodesign(®) anal fistula plug was introduced as a means of obliterating the fistula tract and promoting healing through biocompatibility. The results demonstrated unexplained variations from good to bad. This report analysed the results of a retrospective multicentre study. All plug procedures performed in four Stockholm hospitals between June 2006 and June 2010 were identified and studied using a common protocol. The outcome after the first plug-insertion procedure was assessed by chart review performed a minimum of 8 months after plug insertion. Cox proportional-hazards models were used to assess the associations of various factors with fistula healing. One-hundred and twenty-six patients (mean age 47 years) were deemed suitable for the plug procedure. Eighty-five per cent of fistulae were cryptoglandular, 64% of patients were male and a mean of 2.9 previous fistulae procedures had been performed. All patients, except four, had an indwelling seton at the time of the plug procedure, which was performed in accordance with previously established principles of day surgery. After a median of 13 months, 30 (24%) fistulae had closed with no discomfort or secretion reported. The outcome in the four hospitals varied from 13% to 33% with similar numbers of patients in each hospital. A success rate of 12% was observed for patients with anterior fistula compared with 32% for those with posterior tracks [hazard ratio (HR) for successful healing = 2.98; 95% CI: 1.01-8.78) and 41% for those with a lateral internal opening (HR = 3.76; 95% CI: 1.03-13.75). Age, sex and number of previous procedures were not associated with healing. Four independent patient groups showed low success rates after the first plug-insertion procedure. Anterior fistulae were much less likely to heal compared with fistulae in other locations. Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.

  10. Epidural spinal cord stimulation for neuropathic pain: a neurosurgical multicentric Italian data collection and analysis.

    Science.gov (United States)

    Colombo, Elena Virginia; Mandelli, Carlo; Mortini, Pietro; Messina, Giuseppe; De Marco, Nicola; Donati, Roberto; Irace, Claudio; Landi, Andrea; Lavano, Angelo; Mearini, Massimo; Podetta, Stefano; Servello, Domenico; Zekaj, Edvin; Valtulina, Carlo; Dones, Ivano

    2015-04-01

    Spinal cord stimulation (SCS) is a technique used worldwide to treat several types of chronic neuropathic pain refractory to any conservative treatment. The aim of this data collection is to enforce evidence of SCS effectiveness on neuropathic chronic pain reported in the literature and to speculate on the usefulness of the trial period in determining the long-term efficacy. Moreover, the very low percentage of undesired side effects and complications reported in our case series suggests that all implants should be performed by similarly well-trained and experienced professionals. A multicentric data collection on a common database from 11 Italian neurosurgical departments started 3 years ago. Two different types of electrodes (paddle or percutaneous leads) were used. Of 122 patients, 73 % (N = 89) were submitted to a trial period, while the remaining patients underwent the immediate permanent implant (N = 33). Statistical comparisons of continuous variables between groups were performed. Most of the patients (80 %) had predominant pain to their lower limbs, while only 17 % of patients had prevalent axial pain. Significant reduction in pain, as measured by variation in visual analogue scale (VAS) score, was observed at least 1 year after implantation in 63.8 % of the cases, 59.5 % of patients who underwent a test trial and 71.4 % of patients who underwent permanent implant at once. No statistical differences were found between the lower-limb pain group and the axial pain group. No relevant differences in long-term outcomes were observed in previously tested patients compared with patients implanted at once. Through this analysis we hope to recruit new centres, to give more scientific value to our results.

  11. Severe reduction of blood lysosomal acid lipase activity in cryptogenic cirrhosis: A nationwide multicentre cohort study.

    Science.gov (United States)

    Angelico, Francesco; Corradini, Stefano Ginanni; Pastori, Daniele; Fargion, Silvia; Fracanzani, Anna Ludovica; Angelico, Mario; Bolondi, Luigi; Tozzi, Giulia; Pujatti, Pietro Luigi; Labbadia, Giancarlo; Corazza, Gino Roberto; Averna, Maurizio; Perticone, Francesco; Croce, Giuseppe; Persico, Marcello; Bucci, Tommaso; Baratta, Francesco; Polimeni, Licia; Del Ben, Maria; Violi, Francesco

    2017-07-01

    Blood lysosomal acid lipase (LAL) is reduced in non-alcoholic steatohepatitis, which is the major cause of cryptogenic cirrhosis (CC); few data on LAL activity in CC do exist. We investigated LAL activity in a cohort of patients with liver cirrhosis. This is a multicentre cohort study including 274 patients with liver cirrhosis of different aetiology from 19 centres of Internal Medicine, Gastroenterology and Hepatology distributed throughout Italy. Blood LAL activity (nmol/spot/h) was measured with dried blood spot extracts using Lalistat 2. Overall, 133 patients had CC, and 141 patients had cirrhosis by other causes (61 viral, 53 alcoholic, 20 alcoholic + viral, 7 autoimmune). Mean age was 64.2 ± 13.4 years, and 28.5% were women. Patients with CC were older compared to other aetiology-cirrhosis, with a lower Child-Turcotte-Pugh (CTP, p=0.003) and MELD (p=0.009) score, and a higher prevalence of cardio-metabolic risk factors and previous ischemic events. In the whole cohort, median LAL activity value was 0.58 nmol/spot/h, 0.49 and 0.65 in the groups of CC and known-aetiology cirrhosis, respectively (p=0.002). The difference remained significant after adjustment for white blood cells count (p=0.001). Multivariable linear regression analysis showed that CC (vs. known aetiology, Beta = -0.144, p=0.018), platelet count (Beta = 0.398, p < 0.001) and CTP score (Beta = -0.133, p=0.022) were associated with log-LAL activity. Similar results were found using MELD as covariate. We found a marked reduction of LAL activity in patients with cryptogenic cirrhosis compared to the other known aetiologies. A prospective study will clarify the role of LAL in chronic liver diseases. Copyright © 2017 Elsevier B.V. All rights reserved.

  12. Multi-centre audit of VMAT planning and pre-treatment verification.

    Science.gov (United States)

    Jurado-Bruggeman, Diego; Hernández, Victor; Sáez, Jordi; Navarro, David; Pino, Francisco; Martínez, Tatiana; Alayrach, Maria-Elena; Ailleres, Norbert; Melero, Alejandro; Jornet, Núria

    2017-08-01

    We performed a multi-centre intercomparison of VMAT dose planning and pre-treatment verification. The aims were to analyse the dose plans in terms of dosimetric quality and deliverability, and to validate whether in-house pre-treatment verification results agreed with those of an external audit. The nine participating centres encompassed different machines, equipment, and methodologies. Two mock cases (prostate and head and neck) were planned using one and two arcs. A plan quality index was defined to compare the plans and different complexity indices were calculated to check their deliverability. We compared gamma index pass rates using the centre's equipment and methodology to those of an external audit (global 3D gamma, absolute dose differences, 10% of maximum dose threshold). Log-file analysis was performed to look for delivery errors. All centres fulfilled the dosimetric goals but plan quality and delivery complexity were heterogeneous and uncorrelated, depending on the manufacturer and the planner's methodology. Pre-treatment verifications results were within tolerance in all cases for gamma 3%-3mm evaluation. Nevertheless, differences between the external audit and in-house measurements arose due to different equipment or methodology, especially for 2%-2mm criteria with differences up to 20%. No correlation was found between complexity indices and verification results amongst centres. All plans fulfilled dosimetric constraints, but plan quality and complexity did not correlate and were strongly dependent on the planner and the vendor. In-house measurements cannot completely replace external audits for credentialing. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. Performance of the TB-LAMP diagnostic assay in reference laboratories: Results from a multicentre study.

    Science.gov (United States)

    Pham, Thu Hang; Peter, Jonathan; Mello, Fernanda C Q; Parraga, Tommy; Lan, Nguyen Thi Ngoc; Nabeta, Pamela; Valli, Eloise; Caceres, Tatiana; Dheda, Keertan; Dorman, Susan E; Hillemann, Doris; Gray, Christen M; Perkins, Mark D

    2018-03-01

    To evaluate the diagnostic performance of TB-LAMP, a manual molecular tuberculosis (TB) detection method, and provide comparison to the Xpert MTB/RIF assay. In a large multicentre study, two sputum samples were collected from participants with TB symptoms in reference laboratories in Peru, South Africa, Brazil, and Vietnam. Each sample was tested with TB-LAMP. The reference standard consisted of four direct smears, four cultures, and clinical and radiological findings. Individuals negative on conventional tests were followed up after 8 weeks. The Xpert MTB/RIF assay was performed on fresh or frozen samples as a molecular test comparison. A total of 1036 adults with suspected TB were enrolled. Among 375 culture-confirmed TB cases with 750 sputum samples, TB-LAMP detected 75.6% (95% confidence interval (CI) 71.8-79.4%), including 97.9% (95% CI 96.4-99.4%) of smear-positive TB samples and 46.6% (95% CI 40.6-52.7%) of smear-negative TB samples. Specificity in 477 culture-negative participants not treated for TB (954 sputum samples) was 98.7% (95% CI 97.9-99.6%). TB-LAMP test results were indeterminate in 0.3% of cases. TB-LAMP detects nearly all smear-positive and half of smear-negative TB cases and has a high specificity when performed in reference laboratories. Performance was similar to the Xpert MTB/RIF assay. Copyright © 2018 The Author(s). Published by Elsevier Ltd.. All rights reserved.

  14. Aprotinin vs. tranexamic acid in isolated coronary artery bypass surgery: A multicentre observational study.

    Science.gov (United States)

    Deloge, Elsa; Amour, Julien; Provenchère, Sophie; Rozec, Bertrand; Scherrer, Bruno; Ouattara, Alexandre

    2017-05-01

    Aprotinin appears to be more efficacious than lysine analogues to reduce bleeding and transfusion of blood products in high-transfusion-risk cardiac surgical patients. However, in isolated coronary artery bypass graft (CABG) surgery, the results from head-to-head trials remain less conclusive. Our objective was to compare the efficacies and safety of aprotinin and tranexamic acid (TXA) in patients undergoing isolated on-pump CABG. A multicentre before-and-after study pooling individual data from published trials and unpublished data from three other databases. Four tertiary care teaching hospitals (Haut-Lévêque Hospital in Bordeaux, Pitié-Salpêtrière Hospital and Bichat-Claude Bernard Hospital in Paris, and Laennec Hospital in Nantes). We included data of 2496 isolated on-pump CABG surgery patients who received either aprotinin between November 2003 and May 2008 (n = 1267) or TXA between November 2007 and November 2013 (n = 1229). The primary outcome was total blood loss within 24 h after operation. Secondary outcomes were transfusion of blood products, reoperation for bleeding, renal replacement therapy, ICU length of stay and in-hospital mortality. Adjusted mean (SEM) 24-h blood loss after surgery [483 (11) vs. 634 (11) ml, P < 0.0001] and the proportion of patients requiring intraoperative blood product transfusion (32.7 vs. 46.5%, P = 0.01) were lower in aprotinin-treated patients. No difference was observed with regard to reoperations for bleeding, renal replacement therapy and in-hospital mortality. However, patients receiving aprotinin had a significantly shorter adjusted ICU length of stay. In patients undergoing isolated CABG, aprotinin was more effective than TXA in reducing postoperative blood loss, and no safety concerns were identified. The benefits of aprotinin should be considered when evaluating the risk of major blood loss and transfusion in patients scheduled for isolated CABG surgery.

  15. Prospective, Multicentre, Nationwide Clinical Data from 600 Cases of Acute Pancreatitis.

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    Andrea Párniczky

    Full Text Available The aim of this study was to analyse the clinical characteristics of acute pancreatitis (AP in a prospectively collected, large, multicentre cohort and to validate the major recommendations in the IAP/APA evidence-based guidelines for the management of AP.Eighty-six different clinical parameters were collected using an electronic clinical research form designed by the Hungarian Pancreatic Study Group.600 adult patients diagnosed with AP were prospectively enrolled from 17 Hungarian centres over a two-year period from 1 January 2013.With respect to aetiology, biliary and alcoholic pancreatitis represented the two most common forms of AP. The prevalence of biliary AP was higher in women, whereas alcoholic AP was more common in men. Hyperlipidaemia was a risk factor for severity, lack of serum enzyme elevation posed a risk for severe AP, and lack of abdominal pain at admission demonstrated a risk for mortality. Abdominal tenderness developed in all the patients with severe AP, while lack of abdominal tenderness was a favourable sign for mortality. Importantly, lung injury at admission was associated with mortality. With regard to laboratory parameters, white blood cell count and CRP were the two most sensitive indicators for severe AP. The most common local complication was peripancreatic fluid, whereas the most common distant organ failure in severe AP was lung injury. Deviation from the recommendations in the IAP/APA evidence-based guidelines on fluid replacement, enteral nutrition and timing of interventions increased severity and mortality.Analysis of a large, nationwide, prospective cohort of AP cases allowed for the identification of important determinants of severity and mortality. Evidence-based guidelines should be observed rigorously to improve outcomes in AP.

  16. Scintimammography with technetium-99m methoxyisobutylisonitrile: results of a prospective European multicentre trial

    Energy Technology Data Exchange (ETDEWEB)

    Palmedo, H.; Biersack, H.J. [Bonn Univ. (Germany). Dept. of Nucl. Med.; Lastoria, S. [Department of Nuclear Medicine, National Cancer Institute of Naples (Italy); Maublant, J. [Department of Nuclear Medicine, Centre Jean Perrin in Clermont Ferrand (France); Prats, E. [Department of Nuclear Medicine, University Hospital of Zaragoza (Spain); Stegner, H.E. [Department of Gynecology, University of Hamburg (Germany); Bourgeois, P. [Department of Nuclear Medicine, Hospital St. Pierre in Bruxelles (Belgium); Hustinx, R. [Department of Nuclear Medicine, University Hospital in Liege (Belgium); Hilson, A.J.W. [Department of Nuclear Medicine, NHS Trust Hospital in London (United Kingdom); Bischof-Delaloye, A. [Department of Nuclear Medicine, University of Lausanne (Switzerland)

    1998-04-01

    The aim of the trial was to determine the diagnostic accuracy of scintimmammography with technetium-99m methoxyisobutylisonitrile ({sup 99m}Tc-MIBI) in the detection of primary breast cancer and to verify its clinical usefulness. A total of 246 patients with a suspicious breast mass or positive mammogram were included in this prospective European multicentre trial. At 5 min and 60 min (optional) p.i. two lateral prone images were acquired for 10 min each; 30 min p.i. one anterior image was acquired for 10 min. There were 253 lesions (195 palpable and 58 non-palpable), in respect of which histology revealed 165 cancers and 88 benign lesions. Institutional and blinded read results were correlated to core laboratory histopathology results obtained during excisional biopsy. Diagnostic accuracy for the detection of breast cancer was calculated per lesion. The overall sensitivity and specificity of blinded read scintimammography were 71% and 69%, respectively. For palpable lesions, the sensitivity of blinded read and institutional read scintimammography was 83% and 91%, respectively. Sensitivity was not dependent on the density of the breast tissue. Invasive ductal and invasive lobular cancers showed similar sensitivity. The sensitivity and specificity of mammography were 91% and 42%, respectively, and did not depend on the tumour size. In 60% of false-negative mammograms, {sup 99m}Tc-MIBI was able to diagnose malignancy (true-positive). High-quality imaging with {sup 99m}Tc-MIBI has a high diagnostic accuracy for the detection of primary breast cancer. Used as a complementary method, scintimammography with {sup 99m}Tc-MIBI can help to diagnose breast cancer at an earlier stage in patients with dense breasts. (orig.) With 6 figs., 12 tabs., 55 refs.

  17. Cognitive function in patients on androgen suppression: A prospective, multicentric study.

    Science.gov (United States)

    Morote, J; Tabernero, Á J; Álvarez-Ossorio, J L; Ciria, J P; Domínguez-Escrig, J L; Vázquez, F; Angulo, J; López, F J; de La Iglesia, R; Romero, J

    2018-03-01

    To assess the effect of androgen deprivation therapy (ADT) on cognitive performance (CP) in patients with prostate cancer (PCa) after 6 months of treatment with luteinizing hormone-releasing hormone (LHRH) analogues. Prospective, observational, multicentre, open-label study of patients diagnosed with nonmetastatic or asymptomatic metastatic PCa scheduled to receive LHRH analogues for≥6 months. We assessed four CP domains at baseline and after 6 months of ADT: 1) Working memory: Wechsler Adult Intelligence Scale III (WAIS III) Digit Span Subtest (WAIS III-Digit); 2) Visual memory: ad hoc visual memory test; 3) Visuospatial ability: Judgement of Line Orientation (JLO) and Mental Rotation of Three-Dimensional Objects (3D-Rotation); and 4) Nonverbal analytical reasoning: WAIS III Matrix Reasoning Test (WAIS III-MRT). Changes outside the baseline 95% confidence intervals were considered significant. A total of 308 patients completed the study. Of these, 245 (79.6%) experienced no statistically significant changes on any test and 63 patients (20.4%) experienced significant changes in ≥1 test. Of these, most presented a change in only one test, distributed evenly between improvements (58 patients; 18.8%) and worsening (56 patients; 18.2%). For individual tests, most patients (87.8% to 91.8%) had no change from baseline; however, the significant changes (improvement vs. deterioration, respectively) were as follows: WAIS III-Digit (6.3% vs. 5.9%); visual memory (5.3% vs. 5.7%); JLO (5.3% vs. 4.5%); 3D-Rotation (4.1% vs. 4.1%); and WAIS III-MRT (4.8% vs. 5.8%). CP in patients with PCa does not appear to be adversely affected by 6 months of LHRH analogue administration. Copyright © 2017 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  18. Compartmental analysis of asialoglycoprotein receptor scintigraphy for quantitative measurement of liver function: a multicentre study

    Energy Technology Data Exchange (ETDEWEB)

    Ha-Kawa, Sang Kil [Department of Radiology, Kansai Medical University (Japan); Tanaka, Yoshimasa [Department of Radiology, Kansai Medical University (Japan); Hasebe, Shin [Department of Radiology, Fujigaoka Hospital, Showa University (Japan); Kuniyasu, Yoshio [Department of Radiology, Fujigaoka Hospital, Showa University (Japan); Koizumi, Kiyoshi [Department of Radiology, Yamanashi Medical University (Japan); Ishii, Yasushi [Department of Radiology, Fukui Medical School (Japan); Yamamoto, Kazutaka [Department of Radiology, Fukui Medical School (Japan); Kashiwagi, Toru [Department of Internal Medicine, Osaka Koseinennkin Hospital (Japan); Ito, Akihiko [Department of Internal Medicine, Osaka Koseinennkin Hospital (Japan); Kudo, Masatoshi [Division of Gastroenterology, Kobe City General Hospital (Japan); Ikekubo, Katsuji [Department of Nuclear Medicine, Kobe City General Hospital (Japan); Tsuda, Takaharu [Department of Radiology, Ehime University School of Medicine (Japan); Murase, Kenya [Department of Radiology, Ehime University School of Medicine (Japan)

    1997-02-01

    A multicentre study on multicompartmental analysis of hepatic scintigraphy using technetium-99m labelled galactosyl serum albumin (GSA), which binds to the asialoglycoprotein receptor, was carried out at seven institutions in Japan. Seventy-four patients with liver disease received 3 mg (185 MBq) of {sup 99m}Tc-GSA by intravenous injection. Sequential scanning was performed 30 min after injection to obtain anterior images of the heart and liver, followed by single-photon emission tomography (SPET). The indices included in this analysis were hepatic blood flow (Q) and maximal receptor binding rate (R{sub max}), which showed a good correlation with semiquantitative ratio indices for {sup 99m}Tc-GSA, namely the retention rate in blood (HH15) and the hepatic uptake rate (LHL15). Q and R{sub max}also showed a significant correlation with other measures of hepatic function. When patients were grouped according to the severity of chronic liver damage (hepatocellular functional damage), Q was reduced in the moderate and severe groups, while R {sub max}was reduced in proportion to the functional stage. Both parameters showed no inter-institution difference using analysis of co-variance with the functional stage as a co-variant. With regard to the hepatic uptake rate, anterior planar images and SPET images gave similar results for Q and R {sub max}. Acquisition times of 15 or 30 min provided the same results. The multicompartmental model analysis permitted comparable results to be obtained at institutions using different gamma cameras, and is therefore considered a universally applicable method. These results indicate that Q and R {sub max}are useful general indices for evaluating the functional reserve capacity of the liver. (orig.). With 8 figs., 2 tabs.

  19. Predictors of pre-procedural concentrations of direct oral anticoagulants: a prospective multicentre study.

    Science.gov (United States)

    Godier, Anne; Dincq, Anne-Sophie; Martin, Anne-Céline; Radu, Adrian; Leblanc, Isabelle; Antona, Marion; Vasse, Marc; Golmard, Jean-Louis; Mullier, François; Gouin-Thibault, Isabelle

    2017-08-14

    Patients receiving direct oral anticoagulants (DOACs) frequently undergo elective invasive procedures. Their management is challenging. We aimed to determine the optimal duration of DOAC discontinuation that ensures a minimal anticoagulant effect during the procedure. This prospective multicentre study included 422 DOAC-treated patients requiring an invasive procedure. Pre-procedural DOAC concentration ([DOAC]) and routine haemostasis assays were performed to determine i/the proportion of patients who achieved a minimal pre-procedural [DOAC] (≤30 ng/mL) according to the duration of DOAC discontinuation, ii/the predictors of minimal [DOAC] and, iii/the ability of routine assays to predict minimal [DOAC]. Lastly, we assessed the predictors of peri-procedural bleeding events. The duration of DOAC discontinuation ranged from 1 to 218 h and pre-procedural [DOAC] from ≤30 to 527 ng/mL. After a 49-72-h discontinuation, 95% of the [DOAC] were ≤30 ng/mL. A 72-h discontinuation predicted concentrations ≤30 ng/mL with 91% specificity. In multivariable analysis, duration of DOAC discontinuation, creatinine clearance procedural [DOAC] (concordance statistic 0.869; 95% confidence interval: 0.829-0.912). Conversely, routine haemostasis assays were poor predictors. Last, creatinine clearance procedures were predictors of bleeding events. A last DOAC intake 3 days before a procedure resulted in minimal pre-procedural anticoagulant effect for almost all patients. Moderate renal impairment, especially in dabigatran-treated patients, and antiarrhythmics in anti-Xa-treated patients should result in a longer DOAC interruption. In situations requiring testing, routine assays should not replace DOAC concentration measurement. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

  20. The epidemiology of skin care provided by nurses at home: a multicentre prevalence study.

    Science.gov (United States)

    Kottner, Jan; Boronat, Xavier; Blume-Peytavi, Ulrike; Lahmann, Nils; Suhr, Ralf

    2015-03-01

    The aim of this study was to estimate the frequencies and patterns of skin care and applied skin care products in the home care nursing setting in Germany. Skin care belongs to the core activities of nursing practice. Especially in aged and long-term care settings, clients are vulnerable to various skin conditions. Dry skin is one of the most prevalent problems. Using mild skin cleansers and the regular application of moisturizing leave-on products is recommended. Until today, there are no quantitative empirical data about nursing skin care practice at home in the community. A multicentre cross-sectional study was conducted in July 2012. Home care clients from the German home care nursing setting were randomly selected. Instructed nurse raters performed the data collection using standardized forms. Variables included demographics, skin care needs and skin caring activities. Approximately 60% of home care clients received skin care interventions. The majority were washed and two-thirds received a leave-on product once daily. There was large heterogeneity in cleansing and skin care product use. Most often the product labels were unknown or product types were selected haphazardly. Skin care interventions play a significant role in home care and nurses have a considerable responsibility for skin health. Skin care provided does not meet recent recommendations. The importance of targeted skin cleansing and care might be underestimated. There are a confusing variety of skin care products available and often the labels provide little information regarding the ingredients or guidance about how they affect skin health. © 2014 John Wiley & Sons Ltd.

  1. Laparoscopic excision of deep rectovaginal endometriosis in BSGE endometriosis centres: a multicentre prospective cohort study

    Science.gov (United States)

    Byrne, Dominic; Curnow, Tamara; Smith, Paul; Cutner, Alfred; Saridogan, Ertan; Clark, T Justin

    2018-01-01

    Objective To estimate the effectiveness and safety of laparoscopic surgical excision of rectovaginal endometriosis. Design A multicentre, prospective cohort study. Setting 51 hospitals accredited as specialist endometriosis centres. Participants 5162 women of reproductive age with rectovaginal endometriosis of which 4721 women had planned laparoscopic excision. Interventions Laparoscopic surgical excision of rectovaginal endometriosis requiring dissection of the pararectal space. Main outcome measures Standardised symptom questionnaires enquiring about chronic pelvic pain, bladder and bowel symptoms, analgesia use and quality of life (EuroQol) completed prior to surgery and at 6, 12 and 24 months postoperatively. Serious perioperative and postoperative complications including major haemorrhage, infection and visceral injury were recorded. Results At 6 months postsurgery, there were significant reductions in premenstrual, menstrual and non-cyclical pelvic pain, deep dyspareunia, dyschezia, low back pain and bladder pain. In addition, there were significant reductions in voiding difficulty, bowel frequency, urgency, incomplete emptying, constipation and passing blood. These reductions were maintained at 2 years, with the exception of voiding difficulty. Global quality of life significantly improved from a median pretreatment score of 55/100 to 80/100 at 6 months. There was a significant improvement in quality of life in all measured domains and in quality-adjusted life years. These improvements were sustained at 2 years. All analgesia use was reduced and, in particular, opiate use fell from 28.1% prior to surgery to 16.1% at 6 months. The overall incidence of complications was 6.8% (321/4721). Gastrointestinal complications (enterotomy, anastomotic leak or fistula) occurred in 52 (1.1%) operations and of the urinary tract (ureteric/bladder injury or leak) in 49 (1.0%) procedures. Conclusion Laparoscopic surgical excision of rectovaginal endometriosis

  2. Knowledge and attitudes toward HPV vaccination among healthcare givers: First multicentre survey in Malaysia

    Directory of Open Access Journals (Sweden)

    Shabbir Ahmed Sheikh

    2017-04-01

    Full Text Available Background Cervical cancer is an important public health concern worldwide, and in both developed and developing countries. In Malaysia, cervical cancer is the second most common cancer in women after breast cancer and colorectal cancer. The relation between cervical cancer and oncogenic human papillomavirus (HPV infection has been well-established and it has been reported that almost all cervical cancers are correlated to oncogenic HPV DNA. Worldwide around 70 per cent of cervical cancer cases are caused by HPV type 16 and HPV type 18 and responsible for 90 per cent of penile and anal cancer in men. However, HPV type 6 and 11 cause over 90 per cent of genital warts in both men and women. Aims The objective was to assess the knowledge and attitude level among health givers and to compare among the groups. Methods This was a cross-sectional multi-centre study. Simple random sampling was adopted to collect the data. A questionnaire has been developed and it was pretested. Medical doctors and nurses of Malaysian health service were the study population. The data was evaluated with the necessary statistical tests as applicable. P-values <0.05 was considered statistically significant. Results Total participants of this study were 629. They mainly doctor and nurses. The average age was 31.68±7.20 years. Regarding HPV vaccination, their mean knowledge and attitude scores (SD were 13.32±2.30 and 9.38±1.45 respectively. Conclusion Medical doctors have statistically significantly higher knowledge and attitude scores than paramedical staff. Knowledge level was statistically significantly correlated with attitude. More in-depth prospection interventional research has been advocated to safeguard the Malaysian population from the atrocities of cervical cancer.

  3. [Chronic renal failure, dialysis and transplant: multicentric study: 1996-2003].

    Science.gov (United States)

    Grimoldi, Irene A; Briones, Liliana M; Ferraris, Jorge R; Rodríguez Rilo, Laila; Sojo, Ernesto; Turconi, Amalia; Wainberg, Elena; Zalba, Javier; Sepliarsky, Adrián

    2008-12-01

    The multicentric study of chronic renal failure, dialysis and transplant started in 1996 by the Nephrology Committee of the Argentine Pediatrics Society with the aim of knowing the development characteristics of children with this pathology. The study included children and adolescents on conservative treatment, dialysis or transplant who have registered any of the three modalities before being 19 year-old, since january 1996 to december 2003. The statistical analysis was made with the statistical software SAS; in order to calculate the survival curve, the method employed was Kaplan-Meier and the standardized height and weight z-scores were calculated. In this report, there is data related to 710 patients with chronic renal failure, under conservative treatment 34.2%, dialysis 57.6% and transplant 29.5%. The end-stage renal disease incidence was of 6.5/million inhabitants. The main etiologies were obstructive uropathy 18.3%, reflux nephropathy 15.1%, hemolytic uremic syndrome 14.4%, aplasia/dysplasia/hypoplasia 13.8%, and focal segmental glomerulosclerosis 8.9%. From the patients on dialysis treatment, 62.3% were under hemodialysis, and only 37.7% on peritoneal dialysis. Live-donor sources accounted for 46.2 % of the transplants, with a 1-year patient's survival of 98.7% and a 1-year graft survival of 96.4 %, similar with both donors. The results obtained, even though they do not correspond to the total population affected and the monitoring is still insufficient, allowed us to have a profile of the chronic renal failure in our country.

  4. Characterisation of a plastic scintillation detector to be used in a multicentre stereotactic radiosurgery dosimetry audit

    Science.gov (United States)

    Dimitriadis, A.; Patallo, I. Silvestre; Billas, I.; Duane, S.; Nisbet, A.; Clark, C. H.

    2017-11-01

    Scintillation detectors are considered highly suitable for dosimetric measurement of small fields in radiotherapy due to their near-tissue equivalence and their small size. A commercially available scintillation detector, the Exradin W1 (Standard Imaging, Middleton, USA), has been previously characterised by two independent studies (Beierholm et al., 2014; Carrasco et al., 2015a, 2015b) but the results from these publications differed in some aspects (e.g. energy dependence, long term stability). The respective authors highlighted the need for more studies to be published (Beierholm et al., 2015; Carrasco et al., 2015a, 2015b). In this work, the Exradin W1 was characterised in terms of dose response, dependence on dose rate, energy, temperature and angle of irradiation, and long-term stability. The observed dose linearity, short-term repeatability and temperature dependence were in good agreement with previously published data. Appropriate corrections should therefore be applied, where possible, in order to achieve measurements with low-uncertainty. The angular dependence was characterised along both the symmetrical and polar axis of the detector for the first time in this work and a dose variation of up to 1% was observed. The response of the detector was observed to decrease at a rate of approximately 1.6% kGy-1 for the first 5 kGy delivered, and then stabilised to 0.2% kGy-1 in the subsequent 20 kGy. The main goal of this work was to assess the suitability of the Exradin W1 for use in dose verification measurements for stereotactic radiosurgery. The results obtained confirm that the detector is suitable for use in such situations. The detector is now utilised in a multi-centre stereotactic radiosurgery dosimetric audit, with the application of appropriate correction factors.

  5. Reliability and validity of telephonic Barthel Index: an experience from multi-centric randomized control study.

    Science.gov (United States)

    Prasad, Kameshwar; Kumar, Amit; Misra, Shubham; Yadav, Arun K; Johri, Sarat; Sarkar, R S; Gorthi, S P; Hassan, K M; Prabhakar, Sudesh; Misra, Usha Kant; Kumar, Pradeep

    2018-03-01

    Telephonic Barthel Index (BI) assessment is less time-consuming and more feasible than a face-to-face interview. The aim of this study was to test the validity as well as reliability of the BI administered by telephone in comparison with face-to-face assessment in a multi-centric study. The study was conducted during the course of a randomized controlled trial in which 120 patients with subacute strokes from five teaching hospitals from different parts of India were recruited. Central telephonic follow-up and face-to-face assessment of BI and modified Rankin Scale (mRS) at 3 and 6 months were done by trained and certified blinded researchers. Kappa or weighted kappa (wK) was estimated. Sensitivity and specificity at various cutoff levels of telephonic BI were calculated. Concurrent validity of the telephonic BI was assessed by correlating it with the mRS and National Institutes of Health Stroke Scales (NIHSS) at 3 and 6 months. We observed high sensitivity and specificity at various cutoff levels of BI. Moderate to substantial agreement was observed between the two methods at 6 months wK 0.72 (95% CI 0.70-0.77). Item-wise and center-wise kappa also reflected substantial agreement. The study shows that telephonic assessment of activities of daily living with the BI in moderate to severely disabled stroke patients is valid and reliable compared to face-to-face assessment. Our study shows that telephonic assessment requires smaller sample size compared to face-to-face assessment of BI.

  6. A multi-centre clinical evaluation of reactive oxygen topical wound gel in 114 wounds.

    Science.gov (United States)

    Dryden, M; Dickinson, A; Brooks, J; Hudgell, L; Saeed, K; Cutting, K F

    2016-03-01

    This article reports the outcomes of the use of Surgihoney RO (SHRO), topical wound dressing in a multi-centre, international setting. The aims were to explore the clinical effects of SHRO, including a reduction in bacterial load and biofilm and improvement in healing in a variety of challenging non-healing and clinically infected wounds. This was a non-comparative evaluation, where both acute and chronic wounds with established delayed healing were treated with the dressing. Clinicians prospectively recorded wound improvement or deterioration, level of wound exudate, presence of pain, and presence of slough and necrosis. Analysis of this data provided information on clinical performance of the dressing. Semi-quantitative culture to assess bacterial bioburden was performed where possible. We recruited 104 patients, mean age 61 years old, with 114 wounds. The mean duration of wounds before treatment was 3.7 months and the mean duration of treatment was 25.7 days. During treatment 24 wounds (21%) healed and the remaining 90 (79%) wounds improved following application of the dressing. No deterioration in any wound was observed. A reduction in patient pain, level of wound exudate and in devitalised tissue were consistently reported. These positive improvements in wound progress were reflected in the wound cultures that showed a reduction in bacterial load in 39 out of the 40 swabs taken. There were two adverse events recorded: a stinging sensation following application of the dressing was experienced by 2 patients, and 2 elderly patients died of causes unrelated to the dressing or to the chronic wound. These patients' wounds and their response to SHRO have been included in the analysis. SHRO was well tolerated and shows great promise as an effective potent topical antimicrobial in the healing of challenging wounds. Matthew Dryden has become a shareholder in Matoke Holdings, the manufacturer of Surgihoney RO, since the completion of this study. Keith Cutting is a

  7. Self-confidence and knowledge of German ICU physicians in palliative care - a multicentre prospective study.

    Science.gov (United States)

    Krautheim, Veronika; Schmitz, Andrea; Benze, Gesine; Standl, Thomas; Schiessl, Christine; Waldeyer, Wolfgang; Hapfelmeier, Alexander; Kochs, Eberhard F; Schneider, Gerhard; Wagner, Klaus J; Schulz, Christian M

    2017-11-22

    Little is known about ICU physicians' self-confidence and knowledge related to palliative care. Our objective was to investigate self-confidence and knowledge of German ICU physicians related to palliative care, and to assess the impact of work experience, gender, specialty and additional certifications in pain or palliative medicine. In a multicentre prospective observational study ICU physicians of ten hospitals were asked to rate their self-confidence and to complete a multiple choice questionnaire for the assessment of knowledge. Beyond descriptive statistics and non-parametric tests for group comparisons, linear regression analysis was used to assess the impact of independent variable on self-confidence and knowledge. Spearman's rank test was calculated. 55% of answers in the knowledge test were correct and more than half of the participants rated themselves as "rather confident" or "confident". Linear regression analysis revealed that an additional certificate in either pain or palliative medicine significantly increased both knowledge and self-confidence, but only 15 out of 137 participants had at least one of those certificates. Relation between self-confidence and the results of the knowledge test was weak (r = 0.270 in female) and very weak (r = -0.007 in male). Although the questionnaire needs improvement according to the item analysis, it appears that, with respect to palliative care, ICU Physicians' self-confidence is not related to their knowledge. An additional certificate in either pain or palliative medicine was positively correlated to both self-confidence and knowledge. However, only a minority of the participants were qualified through such a certificate.

  8. Women's breastfeeding experiences following a significant primary postpartum haemorrhage: A multicentre cohort study

    Directory of Open Access Journals (Sweden)

    Ellwood David A

    2010-05-01

    Full Text Available Abstract Background Postpartum haemorrhage (PPH is a significant and increasing contributor to maternal mortality and morbidity. Following a PPH, women may have difficulties initiating and sustaining breastfeeding, although little has been published on this issue. The aim of this study was to describe breastfeeding experiences in a cohort of women following a significant PPH. Methods This is a descriptive study based on quantitative and qualitative data collected via questionnaires completed in the first week postpartum and at two and four months postpartum, by 206 women participating in a multicentre study of women's experiences of a significant primary postpartum haemorrhage (blood loss of 1500 mL or more in the 24 hours following childbirth, and/or a peripartum fall in haemoglobin (Hb concentration to 7g/dL or less, or of ≥ 4g/dL. Results Among women with a significant PPH, 63% fully breastfed their babies from birth, whereas 85% said they had hoped to do so (p In qualitative data, three major themes were identified: 1 Difficulty initiating or sustaining breastfeeding, 2 Need for education and support; and 3 Emotional sequelae. Conclusions Following a significant PPH, women with greater blood loss are less likely to initiate and sustain full breastfeeding and this may be related, in part, to delays in initial contact with their baby as a consequence of the PPH. These findings have implications for postnatal care as these women may require greater support, education and assistance in initiating and sustaining breastfeeding. In particular, enabling the opportunity for the newborn to suckle as soon as is practicable should be encouraged.

  9. An integrated approach to consumer representation and involvement in a multicentre randomized controlled trial.

    Science.gov (United States)

    Langston, Anne L; McCallum, Marilyn; Campbell, Marion K; Robertson, Clare; Ralston, Stuart H

    2005-01-01

    Although, consumer involvement in individual studies is often limited, their involvement in guiding health research is generally considered to be beneficial. This paper outlines our experiences of an integrated relationship between the organisers of a clinical trial and a consumer organisation. The PRISM trial is a UK multicentre, randomized controlled trial comparing treatment strategies for Paget's disease of the bone. The National Association for the Relief of Paget's Disease (NARPD) is the only UK support group for sufferers of Paget's disease and has worked closely with the PRISM team from the outset. NARPD involvement is integral to the conduct of the trial and specific roles have included: peer-review; trial steering committee membership; provision of advice to participants, and promotion of the trial amongst Paget's disease patients. The integrated relationship has yielded benefits to both the trial and the consumer organisation. The benefits for the trial have included: recruitment of participants via NARPD contacts; well-informed participants; unsolicited patient advocacy of the trial; and interested and pro-active collaborators. For the NARPD and Paget's disease sufferers, benefits have included: increased awareness of Paget's disease; increased access to relevant health research; increased awareness of the NARPD services; and wider transfer of diagnosis and management knowledge to/from health care professionals. Our experience has shown that an integrated approach between a trial team and a consumer organisation is worthwhile. Adoption of such an approach in other trials may yield significant improvements in recruitment and quality of participant information flow. There are, however, resource implications for both parties.

  10. Chikungunya infection in India: results of a prospective hospital based multi-centric study.

    Science.gov (United States)

    Ray, Pratima; Ratagiri, Vinod H; Kabra, Sushil K; Lodha, Rakesh; Sharma, Sumit; Sharma, B S; Kalaivani, Mani; Wig, Naveet

    2012-01-01

    Chikungunya (CHIKV) has recently seen a re-emergence in India with high morbidity. However, the epidemiology and disease burden remain largely undetermined. A prospective multi-centric study was conducted to evaluate clinical, epidemiological and virological features of chikugunya infection in patients with acute febrile illness from various geographical regions of India. A total of 540 patients with fever of up to 7 days duration were enrolled at Karnataka Institute of Medical Sciences (KIMS), Karnataka (South); Sawai Man Singh Medical College (SMS) Rajasthan (West), and All India Institute of Medical Sciences (AIIMS) New Delhi (North) from June 2008 to May 2009. Serum specimens were screened for chikungunya infection concurrently through RT-PCR and serology (IgM). Phylogenetic analysis was performed using Bioedit and Mega2 programs. Chikungunya infection was detected in 25.37% patients by RT-PCR and/or IgM-ELISA. Highest cases were detected in south (49.36%) followed by west (16.28%) and north (0.56%) India. A difference in proportion of positives by RT-PCR/ELISA with regard to duration of fever was observed (pchikungunya confirmed cases (pchildren. Anti-CHIK antibodies (IgM) were detected for more than 60 days of fever onset. Phylogenetic analysis based on E1 gene from KIMS patients (n = 15) revealed ∼99% homology clustering with Central/East African genotype. An amino acid change from lysine to glutamine at position 132 of E1 gene was frequently observed among strains infecting children. The study documented re-emergence of chikungunya in high frequencies and severe morbidity in south and west India but rare in north. The study emphasizes the need for continuous surveillance for disease burden using multiple diagnostic tests and also warrants the need for an appropriate molecular diagnostic for early detection of chikungunya virus.

  11. Metabolic syndrome and social deprivation: results of a French observational multicentre survey.

    Science.gov (United States)

    Blanquet, Marie; Debost-Legrand, Anne; Gerbaud, Laurent; de La Celle, Catherine; Brigand, Alain; Mioche, Laurence; Sass, Catherine; Hazart, Juliette; Aw, Alhassane

    2016-02-01

    Deprivation, a process that prevents people to assume their social responsibilities, is a main cause of inequalities in health. Metabolic syndrome has a growing prevalence in France. To assess the association between deprivation and the metabolic syndrome and to identify the most relevant waist circumference cut-off point. A cross-sectional multicentre study was carried out of data extracted from health examination centres of two French areas in 2008. The harmonized definition of the metabolic syndrome contained five criteria with two thresholds for waist circumference. Deprivation was calculated by the Evaluation of Deprivation and Inequalities in Health Examination Centres score (EPICES). Eligible patients were at least 16 years old. The methodology of time to event analysis was used on patients having two criteria to identify the most relevant waist circumference threshold, taking waist circumference as event and computing it as a continuous variable. The median corresponded to the waist circumference threshold for which half of the patients switched from two to three criteria and so metabolic syndrome. Of the 32374 persons included in the study, 39.4% were socially deprived. The prevalence of the metabolic syndrome varied from 16.3% to 22.2% in the overall sample depending on the published waist circumference thresholds chosen. Deprivation was an independent factor associated with the metabolic syndrome. The cut-off point for waist circumference was between 95 and 99 cm for men and 88 and 97 cm for women. Deprivation is associated with a higher prevalence of the metabolic syndrome. The most relevant threshold for waist circumference could be 94 cm for men and 88 cm for women. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  12. A multicentre molecular analysis of hepatitis B and blood-borne virus coinfections in Viet Nam.

    Science.gov (United States)

    Dunford, Linda; Carr, Michael J; Dean, Jonathan; Nguyen, Linh Thuy; Ta Thi, Thu Hong; Nguyen, Binh Thanh; Connell, Jeff; Coughlan, Suzie; Nguyen, Hien Tran; Hall, William W; Thi, Lan Anh Nguyen

    2012-01-01

    Hepatitis B (HBV) infection is endemic in Viet Nam, with up to 8.4 million individuals estimated to be chronically infected. We describe results of a large, multicentre seroepidemiological and molecular study of the prevalence of HBV infection and blood-borne viral coinfections in Viet Nam. Individuals with varying risk factors for infection (n = 8654) were recruited from five centres; Ha Noi, Hai Phong, Da Nang, Khanh Hoa and Can Tho. A mean prevalence rate of 10.7% was observed and levels of HBsAg were significantly higher in injecting drug users (IDUs) (17.4%, n = 174/1000) and dialysis patients (14.3%, n = 82/575) than in lower-risk groups (9.4%; pa predominance of genotype B4 (82.6%); genotypes C1 (14.6%), B2 (2.7%) and C5 (0.5%) were also identified. The precore mutation G1896A was identified in 35% of all specimens, and was more frequently observed in genotype B (41%) than genotype C (3%; pa' region of the surface gene, point mutations were identified in 31% (n = 58/187) of sequences, and 2.2% (n = 4/187) and 5.3% (n = 10/187) specimens contained the major vaccine escape mutations G145A/R and P120L/Q/S/T, respectively. 368 HBsAg positive individuals were genotyped for the IL28B SNP rs12979860 and no significant association between the IL28B SNP and clearance of HBsAg, HBV viral load or HBeAg was observed. This study confirms the high prevalence of HBV infection in Viet Nam and also highlights the significant levels of blood-borne virus coinfections, which have important implications for hepatitis-related morbidity and development of effective management strategies.

  13. Homeopathy in chronic sinusitis: a prospective multi-centric observational study.

    Science.gov (United States)

    Nayak, Chaturbhuja; Singh, Vikram; Singh, V P; Oberai, Praveen; Roja, Varanasi; Shitanshu, Shashi Shekhar; Sinha, M N; Deewan, Deepti; Lakhera, B C; Ramteke, Sunil; Kaushik, Subhash; Sarkar, Sarabjit; Mandal, N R; Mohanan, P G; Singh, J R; Biswas, Sabyasachi; Mathew, Georgekutty

    2012-04-01

    The primary objective was to ascertain the therapeutic usefulness of homeopathic medicine in the management of chronic sinusitis (CS). Multicentre observational study at Institutes and Units of the Central Council for Research in Homoeopathy, India. Symptoms were assessed using the chronic sinusitis assessment score (CSAS). 17 pre-defined homeopathic medicines were shortlisted for prescription on the basis of repertorisation for the pathological symptoms of CS. Regimes and adjustment of regimes in the event of a change of symptoms were pre-defined. The follow-up period was for 6 months. Statistical analysis was done using SPSS version 16. 628 patients suffering from CS confirmed on X-ray were enrolled from eight Institutes and Units of the Central Council for Research in Homoeopathy. All 550 patients with at least one follow-up assessment were analyzed. There was a statistically significant reduction in CSAS (P = 0.0001, Friedman test) after 3 and 6 months of treatment. Radiological appearances also improved. A total of 13 out of 17 pre-defined medicines were prescribed in 550 patients, Sil. (55.2% of 210), Calc. (62.5% of 98), Lyc. (69% of 55), Phos. (66.7% of 45) and Kali iod. (65% of 40) were found to be most useful having marked improvement. 4/17 medicines were never prescribed. No complications were observed during treatment. Homeopathic treatment may be effective for CS patients. Controlled trials are required for further validation. Copyright © 2012 Elsevier Ltd. All rights reserved.

  14. A prospective multi-centric open clinical trial of homeopathy in diabetic distal symmetric polyneuropathy.

    Science.gov (United States)

    Nayak, Chaturbhuja; Oberai, Praveen; Varanasi, Roja; Baig, Hafeezullah; Ch, Raveender; Reddy, G R C; Devi, Pratima; S, Bhubaneshwari; Singh, Vikram; Singh, V P; Singh, Hari; Shitanshu, Shashi Shekhar

    2013-04-01

    To evaluate homeopathic treatment in the management of diabetic distal symmetric polyneuropathy. A prospective multi-centric clinical observational study was carried out from October 2005 to September 2009 by Central Council for Research in Homeopathy (CCRH) (India) at its five institutes/units. Patients suffering from diabetes mellitus (DM) and presenting with symptoms of diabetic polyneuropathy (DPN) were screened, investigated and were enrolled in the study after fulfilling the inclusion and exclusion criteria. Patients were evaluated by the diabetic distal symmetric polyneuropathy symptom score (DDSPSS) developed by the Council. A total of 15 homeopathic medicines were identified after repertorizing the nosological symptoms and signs of the disease. The appropriate constitutional medicine was selected and prescribed in 30, 200 and 1 M potency on an individualized basis. Patients were followed up regularly for 12 months. Out of 336 patients (167 males and 169 females) enrolled in the study, 247 patients (123 males and 124 females) were analyzed. All patients who attended at least three follow-up appointments and baseline curve conduction studies were included in the analysis.). A statistically significant improvement in DDSPSS total score (p = 0.0001) was found at 12 months from baseline. Most objective measures did not show significant improvement. Lycopodium clavatum (n = 132), Phosphorus (n = 27) and Sulphur (n = 26) were the medicines most frequently prescribed. Adverse event of hypoglycaemia was observed in one patient only. This study suggests homeopathic medicines may be effective in managing the symptoms of DPN patients. Further studies should be controlled and include the quality of life (QOL) assessment. Copyright © 2013 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  15. Multicentre evaluation of a novel vaginal dose reporting method in 153 cervical cancer patients.

    Science.gov (United States)

    Westerveld, Henrike; de Leeuw, Astrid; Kirchheiner, Kathrin; Dankulchai, Pittaya; Oosterveld, Bernard; Oinam, Arun; Hudej, Robert; Swamidas, Jamema; Lindegaard, Jacob; Tanderup, Kari; Pötter, Richard; Kirisits, Christian

    2016-09-01

    Recently, a vaginal dose reporting method for combined EBRT and BT in cervical cancer patients was proposed. The current study was to evaluate vaginal doses with this method in a multicentre setting, wherein different applicators, dose rates and protocols were used. In a subset of patients from the EMBRACE study, vaginal doses were evaluated. Doses at the applicator surface left/right and anterior/posterior and at 5mm depth were measured. In addition, the dose at the Posterior-Inferior Border of Symphysis (PIBS) vaginal dose point and PIBS±2cm, corresponding to the mid and lower vagina, was measured. 153 patients from seven institutions were included. Large dose variations expressed in EQD2 with α/β=3Gy were seen between patients, in particular at the top left and right vaginal wall (median 195 (range 61-947)Gy/178 (61-980)Gy, respectively). At 5mm depth, doses were 98 (55-212)Gy/91 (54-227)Gy left/right, and 71 (51-145)Gy/67 (49-189)Gy anterior/posterior, respectively. The dose at PIBS and PIBS±2cm was 41 (3-81)Gy, 54 (32-109)Gy and 5 (1-51)Gy, respectively. At PIBS+2cm (mid vagina) dose variation was coming from BT. The variation at PIBS-2cm (lower vagina) was mainly dependent on EBRT field border location. This novel method for reporting vaginal doses coming from EBRT and BT through well-defined dose points gives a robust representation of the dose along the vaginal axis. In addition, it allows comparison of vaginal dose between patients from different centres. The doses at the PIBS points represent the doses at the mid and lower parts of the vagina. Large variations in dose throughout the vagina were observed between patients and centres. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  16. Blunt Cardiac Injury in the Severely Injured - A Retrospective Multicentre Study.

    Science.gov (United States)

    Hanschen, Marc; Kanz, Karl-Georg; Kirchhoff, Chlodwig; Khalil, Philipe N; Wierer, Matthias; van Griensven, Martijn; Laugwitz, Karl-Ludwig; Biberthaler, Peter; Lefering, Rolf; Huber-Wagner, Stefan

    2015-01-01

    Blunt cardiac injury is a rare trauma entity. Here, we sought to evaluate the relevance and prognostic significance of blunt cardiac injury in severely injured patients. In a retrospective multicentre study, using data collected from 47,580 patients enrolled to TraumaRegister DGU (1993-2009), characteristics of trauma, prehospital / hospital trauma management, and outcome analysis were correlated to the severity of blunt cardiac injury. The severity of cardiac injury was assessed according to the abbreviated injury score (AIS score 1-6), the revised injury severity score (RISC) allowed comparison of expected outcome with injury severity-dependent outcome. N = 1.090 had blunt cardiac trauma (AIS 1-6) (2.3% of patients). Predictors of blunt cardiac injury could be identified. Sternal fractures indicate a high risk of the presence of blunt cardiac injury (AIS 0 [control]: 3.0%; AIS 1: 19.3%; AIS 2-6: 19.1%). The overall mortality rate was 13.9%, minor cardiac injury (AIS 1) and severe cardiac injury (AIS 2-6) are associated with higher rates. Severe blunt cardiac injury (AIS 4 and AIS 5-6) is associated with a higher mortality (OR 2.79 and 4.89, respectively) as compared to the predicted average mortality (OR 2.49) of the study collective. Multiple injured patients with blunt cardiac trauma are at high risk to be underestimated. Careful evaluation of trauma patients is able to predict the presence of blunt cardiac injury. The severity of blunt cardiac injury needs to be stratified according to the AIS score, as the patients' outcome is dependent on the severity of cardiac injury.

  17. Blunt Cardiac Injury in the Severely Injured – A Retrospective Multicentre Study

    Science.gov (United States)

    Hanschen, Marc; Kanz, Karl-Georg; Kirchhoff, Chlodwig; Khalil, Philipe N.; Wierer, Matthias; van Griensven, Martijn; Laugwitz, Karl-Ludwig; Biberthaler, Peter; Lefering, Rolf; Huber-Wagner, Stefan

    2015-01-01

    Background Blunt cardiac injury is a rare trauma entity. Here, we sought to evaluate the relevance and prognostic significance of blunt cardiac injury in severely injured patients. Methods In a retrospective multicentre study, using data collected from 47,580 patients enrolled to TraumaRegister DGU (1993-2009), characteristics of trauma, prehospital / hospital trauma management, and outcome analysis were correlated to the severity of blunt cardiac injury. The severity of cardiac injury was assessed according to the abbreviated injury score (AIS score 1-6), the revised injury severity score (RISC) allowed comparison of expected outcome with injury severity-dependent outcome. N = 1.090 had blunt cardiac trauma (AIS 1-6) (2.3% of patients). Results Predictors of blunt cardiac injury could be identified. Sternal fractures indicate a high risk of the presence of blunt cardiac injury (AIS 0 [control]: 3.0%; AIS 1: 19.3%; AIS 2-6: 19.1%). The overall mortality rate was 13.9%, minor cardiac injury (AIS 1) and severe cardiac injury (AIS 2-6) are associated with higher rates. Severe blunt cardiac injury (AIS 4 and AIS 5-6) is associated with a higher mortality (OR 2.79 and 4.89, respectively) as compared to the predicted average mortality (OR 2.49) of the study collective. Conclusion Multiple injured patients with blunt cardiac trauma are at high risk to be underestimated. Careful evaluation of trauma patients is able to predict the presence of blunt cardiac injury. The severity of blunt cardiac injury needs to be stratified according to the AIS score, as the patients’ outcome is dependent on the severity of cardiac injury. PMID:26136126

  18. Blunt traumatic aortic injuries of the ascending aorta and aortic arch: a clinical multicentre study.

    Science.gov (United States)

    Mosquera, Victor X; Marini, Milagros; Muñiz, Javier; Gulias, Daniel; Asorey-Veiga, Vanesa; Adrio-Nazar, Belen; Herrera, José M; Pradas-Montilla, Gonzalo; Cuenca, José J

    2013-09-01

    To report the clinical and radiological characteristics, management and outcomes of traumatic ascending aorta and aortic arch injuries. Historic cohort multicentre study including 17 major trauma patients with traumatic aortic injury from January 2000 to January 2011. The most common mechanism of blunt trauma was motor-vehicle crash (47%) followed by motorcycle crash (41%). Patients sustaining traumatic ascending aorta or aortic arch injuries presented a high proportion of myocardial contusion (41%); moderate or greater aortic valve regurgitation (12%); haemopericardium (35%); severe head injuries (65%) and spinal cord injury (23%). The 58.8% of the patients presented a high degree aortic injury (types III and IV). Expected in-hospital mortality was over 50% as defined by mean TRISS 59.7 (SD 38.6) and mean ISS 48.2 (SD 21.6) on admission. Observed in-hospital mortality was 53%. The cause of death was directly related to the ATAI in 45% of cases, head and abdominal injuries being the cause of death in the remaining 55% cases. Long-term survival was 46% at 1 year, 39% at 5 years, and 19% at 10 years. Traumatic aortic injuries of the ascending aorta/arch should be considered in any major thoracic trauma patient presenting cardiac tamponade, aortic valve regurgitation and/or myocardial contusion. These aortic injuries are also associated with a high incidence of neurological injuries, which can be just as lethal as the aortic injury, so treatment priorities should be modulated on an individual basis. Copyright © 2012 Elsevier Ltd. All rights reserved.

  19. Blunt Cardiac Injury in the Severely Injured - A Retrospective Multicentre Study.

    Directory of Open Access Journals (Sweden)

    Marc Hanschen

    Full Text Available Blunt cardiac injury is a rare trauma entity. Here, we sought to evaluate the relevance and prognostic significance of blunt cardiac injury in severely injured patients.In a retrospective multicentre study, using data collected from 47,580 patients enrolled to TraumaRegister DGU (1993-2009, characteristics of trauma, prehospital / hospital trauma management, and outcome analysis were correlated to the severity of blunt cardiac injury. The severity of cardiac injury was assessed according to the abbreviated injury score (AIS score 1-6, the revised injury severity score (RISC allowed comparison of expected outcome with injury severity-dependent outcome. N = 1.090 had blunt cardiac trauma (AIS 1-6 (2.3% of patients.Predictors of blunt cardiac injury could be identified. Sternal fractures indicate a high risk of the presence of blunt cardiac injury (AIS 0 [control]: 3.0%; AIS 1: 19.3%; AIS 2-6: 19.1%. The overall mortality rate was 13.9%, minor cardiac injury (AIS 1 and severe cardiac injury (AIS 2-6 are associated with higher rates. Severe blunt cardiac injury (AIS 4 and AIS 5-6 is associated with a higher mortality (OR 2.79 and 4.89, respectively as compared to the predicted average mortality (OR 2.49 of the study collective.Multiple injured patients with blunt cardiac trauma are at high risk to be underestimated. Careful evaluation of trauma patients is able to predict the presence of blunt cardiac injury. The severity of blunt cardiac injury needs to be stratified according to the AIS score, as the patients' outcome is dependent on the severity of cardiac injury.

  20. Integrative medicine for subacute stroke rehabilitation: a study protocol for a multicentre, randomised, controlled trial

    Science.gov (United States)

    Fang, Jianqiao; Chen, Lifang; Chen, Luni; Wang, Chao; Keeler, Crystal Lynn; Ma, Ruijie; Xu, Shouyu; Shen, Laihua; Bao, Yehua; Ji, Conghua

    2014-01-01

    Introduction Many patients with stroke receive integrative medicine in China, which includes the basic treatment of Western medicine and routine rehabilitation, in conjunction with acupuncture and Chinese medicine. The question of whether integrative medicine is efficacious for stroke rehabilitation is still controversial and very little research currently exists on the integrated approach for this condition. Consequently, we will conduct a multicentre, randomised, controlled, assessor-blinded clinical trial to assess the effectiveness of integrative medicine on stroke rehabilitation. Methods and analysis 360 participants recruited from three large Chinese medical hospitals in Zhejiang Province will be randomly divided into the integrative medicine rehabilitation (IMR) group and the conventional rehabilitation (CR) group in a 1:1 ratio. Participants in the IMR group will receive acupuncture and Chinese herbs in addition to basic Western medicine and rehabilitation treatment. The CR group will not receive acupuncture and Chinese herbal medicine. The assessment data will be collected at baseline, 4 and 8 weeks postrandomisation, and then at 12 weeks’ follow-up. The primary outcome is measured by the Modified Barthel Index. The secondary outcomes are the National Institutes of Health Stroke Scale (NIHSS), Fugl-Meyer Assessment, the mini-mental state examination and Montreal Cognitive, Hamilton's Depression Scale and Self-Rating Depression Scale, and the incidence of adverse events. Ethics and dissemination Ethical approval was obtained from ethics committees of three hospitals. The results will be disseminated in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients by telephone, during follow-up calls inquiring on patient's post-study health status. Trial registration number Chinese Clinical Trial Register: ChiCTR-TRC-12001972, http://www.chictr.org/en/proj/show.aspx?proj=2561 PMID:25475247

  1. Outcome of physiotherapy after surgery for cervical disc disease: a prospective randomised multi-centre trial

    Science.gov (United States)

    2014-01-01

    Background Many patients with cervical disc disease require leave from work, due to long-lasting, complex symptoms, including chronic pain and reduced levels of physical and psychological function. Surgery on a few segmental levels might be expected to resolve disc-specific pain and reduce neurological deficits, but not the non-specific neck pain and the frequent illness. No study has investigated whether post-surgery physiotherapy might improve the outcome of surgery. The main purpose of this study was to evaluate whether a well-structured rehabilitation programme might add benefit to the customary post-surgical treatment for cervical disc disease, with respect to function, disability, work capability, and cost effectiveness. Methods/Design This study was designed as a prospective, randomised, controlled, multi-centre study. An independent, blinded investigator will compare two alternatives of rehabilitation. We will include 200 patients of working age, with cervical disc disease confirmed by clinical findings and symptoms of cervical nerve root compression. After providing informed consent, study participants will be randomised to one of two alternative physiotherapy regimes; (A) customary treatment (information and advice on a specialist clinic); or (B) customary treatment plus active physiotherapy. Physiotherapy will follow a standardised, structured programme of neck-specific exercises combined with a behavioural approach. All patients will be evaluated both clinically and subjectively (with questionnaires) before surgery and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. The main outcome variable will be neck-specific disability. Cost-effectiveness will also be calculated. Discussion We anticipate that the results of this study will provide evidence to support physiotherapeutic rehabilitation applied after surgery for cervical radiculopathy due to cervical disc disease. Trial registration ClinicalTrials.gov identifier: NCT01547611

  2. Early multicentre experience of pre-pectoral implant based immediate breast reconstruction using Braxon®.

    Science.gov (United States)

    Jafferbhoy, Sadaf; Chandarana, Mihir; Houlihan, Maria; Parmeshwar, Rishikesh; Narayanan, Sankaran; Soumian, Soni; Harries, Simon; Jones, Lucie; Clarke, Dayalan

    2017-12-01

    The last two decades have seen significant changes in surgical management of breast cancer. The offer of immediate breast reconstruction (IBR) following mastectomy is currently standard practice. Skin sparing and nipple sparing mastectomy with implant-based IBR have emerged as oncologically safe treatment options. Prepectoral implant placement and complete coverage of implant with acellular dermal matrix (ADM) eliminates the need to detach the muscle from underlying chest wall in contrast to the subpectoral technique. We report short-term outcomes of a multicentre study from the United Kingdom (UK) using Braxon ® in women having an IBR. A prospective study was conducted from December 2015 to October 2016 and included all patients from three breast units in the UK who underwent a mastectomy and an implant-based IBR using Braxon ® . The demographic details, co-morbidities, operative details, immediate and delayed complications were recorded. Specific complications recorded were infection, seroma, unplanned readmission and loss of implant. A comparison was made with complications reported in the National Mastectomy and Reconstruction Audit. Seventy-eight IBRs were included in the analysis with a median follow-up of 9.98 months. Mean age of the cohort was 50 years with a mean body mass index of 25.7 kg/m 2 . Mean implant volume was 365 cc. The inpatient hospital stay was 1.48 days. About 23% of patients had a seroma, 30% had erythema requiring antibiotics and the explant rate was 10.2 percent. Bilateral reconstructions were significantly associated with implant loss and peri-operative complications on univariate analysis. Our early experience with this novel prepectoral technique using Braxon ® has shown it to be an effective technique with complication rates comparable to subpectoral IBR. The advantages of prepectoral implant-based IBR are quicker postoperative recovery and short post-operative hospital stay. Long-term studies are required to assess rippling, post

  3. Erysipelas of the leg (cellulitis in sub-Saharan Africa: A multicentric study of 562 cases

    Directory of Open Access Journals (Sweden)

    Bayaki Saka

    2017-01-01

    Full Text Available Introduction: Erysipelas of the leg is a common and serious infection. We carried out this study aiming at describing the epidemiological and clinical characteristics, and assessing the risks factors associated with the local complications of erysipelas of the leg in sub-Saharan Africa. Methods: This was a prospective multicentric study carried out in the dermatology units of Hospitals located in seven sub-Saharan African countries during a period of 12 months. Patients aged 15 and above with a first episode of erysipelas of the leg were recruited. Results: In this study, 562 patients were recruited, having a mean age of 43.7±16.9 years and a sex-ratio (M/F of 0.67. Patients infected on one leg were 562 while those infected with two were 27. Bullous forms of the disease were observed in 95 patients, while purpuric forms were observed in 167 patients. The existence of a point of entry (485 cases, obesity (230, lymph edema (130 and the use of bleaching agents (97 were the mains risk factors. Complications during the course of the infection such as necrotizing fasciitis (34 cases and abscesses (63 cases were observed. They were due to the use of antibiotics and non-steroidal anti-inflammatory treatments, and the use of cataplasm. Conclusion: This study reveals that existence of a point of entry, obesity and lymph edema, and the use of bleaching agents were the mains risk factors influencing the local complications of erysipelas of the leg. Necrotizing fasciitis and abscesses were influenced by the use of antibiotics and non-steroidal anti-inflammatory treatments, and the use of cataplasm.

  4. Patient satisfaction in out-of-hospital emergency care: a multicentre survey.

    Science.gov (United States)

    Neumayr, Agnes; Gnirke, André; Schaeuble, Joerg C; Ganter, Michael T; Sparr, Harald; Zoll, Adolf; Schinnerl, Adolf; Nuebling, Matthias; Heidegger, Thomas; Baubin, Michael

    2016-10-01

    There is only limited information on patient satisfaction with emergency medical services (EMS). The aim of this multicentre survey was to evaluate patient satisfaction in five out-of-hospital physician-based EMS in Austria and Switzerland. The psychometrically tested and standardized questionnaire 'patient satisfaction in out-of-hospital emergency care' was used for this survey. The recruitment of the patients was carried out on the basis of inclusion and exclusion criteria. All questionnaires were sent together with an invitation letter and a prepaid return envelope, followed by a reminder 2 weeks later. The descriptive statistical analysis was carried out by an external organization to maintain anonymity. The response rate of all EMS was 46.7%. High satisfaction rates were achieved for the four quality scales 'emergency call, emergency treatment, transport and hospital admission'. A significant difference was found between the Swiss and the Austrian dispatch centres in the judgement of the call takers' social skills. Patient satisfaction with the emergency treatment, for example, reduction of pain, was high in all EMS, independent of whether the EMS is physician (Austria) or physician and emergency medical assistant based (Switzerland). Lowest satisfaction rates were found for items of social skills. Patient satisfaction in out-of-hospital physician-based EMS is generally high. There is room for improvement in areas such as the social skills of dispatchers and EMS-team members and the comfort of the patients during transport. A checklist should be developed for basic articles that patients should take along to hospital and for questions on responsibilities for children, dependent people or pets.

  5. Multicentre assessment and monitored use of [18F]FDG-PET in oncology: the Spanish experience

    International Nuclear Information System (INIS)

    Rodriguez-Garrido, Manuel; Asensio-del-Barrio, Cristina

    2008-01-01

    The aim of this study was to evaluate the diagnostic effectiveness of [ 18 F]FDG-PET in oncological diseases and to assess its clinical utility and impact (on the clinical and therapeutic management of these patients). This health technology assessment was performed in Spain, using the monitored use (MU) procedure. A multicentre and prospective follow-up study was performed in a non-consecutive sample of oncological patients who were examined with PET and other conventional diagnostic tests. A protocol for this MU method (PET-MU protocol) was developed, including the three forms used to collect all the information. Enrolment of new patients began in June 2002 and continued until August 2004. A descriptive analysis and an evaluation of the diagnostic effectiveness of FDG-PET were performed. The study population comprised 2,824 oncological patients (the third form relating to follow-up was completed for only 967 of these patients) from 100 Spanish hospitals and 16 PET centres. Seventy-nine percent of cases met the clinical requirements of the PET-MU protocol. Global diagnostic parameters of PET performance and their 95% CI values were as follows: sensitivity 86% (82-89%), specificity 83% (79-86%), positive and negative predictive values 87% (83-90%) and 82% (77-85%) respectively, diagnostic accuracy 84% (82-87%) and diagnostic odds ratio 28.75 (19.75-41.84). PET detected unsuspected new lesions in 39% of patients and avoided other unnecessary diagnostic techniques and treatments in 69% of cases. In 88% of cases, PET was considered useful by the physicians who asked for the PET tests (it was deemed decisive in 30% and very useful in almost 37%). This PET-MU study has confirmed the high diagnostic effectiveness of FDG-PET for oncological indications and demonstrates that it has a great influence on the clinical and therapeutic management of patients. (orig.)

  6. Psychological morbidity and return to work after injury: multicentre cohort study.

    Science.gov (United States)

    Kendrick, Denise; Dhiman, Paula; Kellezi, Blerina; Coupland, Carol; Whitehead, Jessica; Beckett, Kate; Christie, Nicola; Sleney, Judith; Barnes, Jo; Joseph, Stephen; Morriss, Richard

    2017-08-01

    The benefits of work for physical, psychological, and financial wellbeing are well documented. Return to work (RTW) after unintentional injury is often delayed, and psychological morbidity may contribute to this delay. The impact of psychological morbidity on RTW after a wide range of unintentional injuries in the UK has not been adequately quantified. To quantify the role of psychological factors, including anxiety, depression, and post-traumatic distress, on RTW following unintentional injuries. A longitudinal multicentre prospective study was undertaken in Nottingham, Bristol, Leicester, and Guildford, UK. Participants ( n = 273) were 16-69-year-olds admitted to hospital following unintentional injury, who were in paid employment prior to injury. They were surveyed at baseline, then at 1, 2, 4, and 12 months following injury; demographic data were collected along with injury characteristics, psychological morbidity, and RTW status. Associations between demographic, injury and psychological factors, and RTW between 2 and 12 months after injury were quantified using random effects logistic regression. The odds of RTW between 2 and 12 months after injury reduced as depression scores early in the recovery period (1 month after injury) increased (odds ratio [OR] 0.87, 95% confidence interval [CI] = 0.79 to 0.95) and as length of hospital stay increased (OR 0.91, 95% CI] = 0.86 to 0.96). For those experiencing threatening life events following injury (OR 0.27, 95% CI = 0.10 to 0.72) and with higher scores on the Crisis Support Scale (OR 0.93, 95% CI] = 0.88 to 0.99), the odds of RTW between 2 and 12 months after injury were lower. Multiple imputation analysis found similar results, but those relating to crisis support did not remain statistically significant. Primary care professionals can identify patients at risk of delayed RTW who may benefit from management of psychological morbidity and support to RTW. © British Journal of General Practice 2017.

  7. Psychological morbidity and health-related quality of life after injury: multicentre cohort study.

    Science.gov (United States)

    Kendrick, D; Kelllezi, B; Coupland, C; Maula, A; Beckett, K; Morriss, R; Joseph, S; Barnes, J; Sleney, J; Christie, N

    2017-05-01

    To demonstrate the impact of psychological morbidity 1 month post-injury on subsequent post-injury quality of life (HRQoL) in a general injury population in the UK to inform development of trauma care and rehabilitation services. Multicentre cohort study of 16-70-year-olds admitted to 4 UK hospitals following injury. Psychological morbidity and HRQoL (EQ-5D-3L) were measured at recruitment and 1, 2, 4 and 12 months post-injury. A reduction in EQ-5D compared to retrospectively assessed pre-injury levels of at least 0.074 was taken as the minimal important difference (MID). Multilevel logistic regression explored relationships between psychological morbidity 1 month post-injury and MID in HRQoL over the 12 months after injury. A total of 668 adults participated. Follow-up rates were 77% (1 month) and 63% (12 months). Substantial reductions in HRQoL were seen; 93% reported a MID at 1 month and 58% at 12 months. Problems with pain, mobility and usual activities were commonly reported at each time point. Depression and anxiety scores 1 month post-injury were independently associated with subsequent MID in HRQoL. The relationship between depression and HRQoL was partly explained by anxiety and to a lesser extent by pain and social functioning. The relationship between anxiety and HRQoL was not explained by factors measured in our study. Hospitalised injuries result in substantial reductions in HRQoL up to 12 months later. Depression and anxiety early in the recovery period are independently associated with lower HRQoL. Identifying and managing these problems, ensuring adequate pain control and facilitating social functioning are key elements in improving HRQoL post-injury.

  8. The impact of psychological factors on recovery from injury: a multicentre cohort study.

    Science.gov (United States)

    Kellezi, Blerina; Coupland, C; Morriss, R; Beckett, K; Joseph, S; Barnes, J; Christie, N; Sleney, J; Kendrick, D

    2017-07-01

    Unintentional injuries have a significant long-term health impact in working age adults. Depression, anxiety and post-traumatic stress disorder are common post-injury, but their impact on self-reported recovery has not been investigated in general injury populations. This study investigated the role of psychological predictors 1 month post-injury in subsequent self-reported recovery from injury in working-aged adults. A multicentre cohort study was conducted of 668 unintentionally injured adults admitted to five UK hospitals followed up at 1, 2, 4 and 12 months post-injury. Logistic regression explored relationships between psychological morbidity 1 month post-injury and self-reported recovery 12 months post-injury, adjusting for health, demographic, injury and socio-legal factors. Multiple imputations were used to impute missing values. A total of 668 adults participated at baseline, 77% followed up at 1 month and 63% at 12 months, of whom 383 (57%) were included in the main analysis. Multiple imputation analysis included all 668 participants. Increasing levels of depression scores and increasing levels of pain at 1 month and an increasing number of nights in hospital were associated with significantly reduced odds of recovery at 12 months, adjusting for age, sex, centre, employment and deprivation. The findings were similar in the multiple imputation analysis, except that pain had borderline statistical significance. Depression 1 month post-injury is an important predictor of recovery, but other factors, especially pain and nights spent in hospital, also predict recovery. Identifying and managing depression and providing adequate pain control are essential in clinical care post-injury.

  9. Poison prevention practices and medically attended poisoning in young children: multicentre case-control study.

    Science.gov (United States)

    Kendrick, Denise; Majsak-Newman, Gosia; Benford, Penny; Coupland, Carol; Timblin, Clare; Hayes, Mike; Goodenough, Trudy; Hawkins, Adrian; Reading, Richard

    2017-04-01

    Childhood poisonings are common, placing a substantial burden on health services. Case-control studies have found inconsistent evidence about modifiable risk factors for poisonings among children aged 0-4 years. This study quantifies associations between poison prevention practices and medically attended poisonings in children aged 0-4 years. Multicentre case-control study conducted at hospitals, minor injury units and family practices from four study centres in England between 2010 and 2013. Participants comprised 567 children presenting with unintentional poisoning occurring at home and 2320 community control participants matched on age, sex, date of event and study centre. Parents/caregivers provided data on safety practices, safety equipment use, home hazards and potential confounders by means of self-completion questionnaires. Data were analysed using conditional logistic regression. Compared with community controls, parents of poisoned children were significantly more likely not to store medicines out of reach (adjusted OR (AOR) 1.59; 95% CI 1.21 to 2.09; population attributable fraction (PAF) 15%), not to store medicines safely (locked or out of reach (AOR 1.83; 95% CI 1.38 to 2.42; PAF 16%) and not to have put all medicines (AOR 2.11; 95% CI 1.54 to 2.90; PAF 20%) or household products (AOR 1.79, 95% CI 1.29 to 2.48; PAF 11%) away immediately after use. Not storing medicines out of reach or locked away and not putting medicines and household products away immediately after use increased the odds of secondary care attended poisonings in children aged 0-4 years. If associations are causal, implementing these poison prevention practices could each prevent between 11% and 20% of poisonings. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  10. Ex post facto assessment of diffusion tensor imaging metrics from different MRI protocols: preparing for multicentre studies in ALS.

    Science.gov (United States)

    Rosskopf, Johannes; Müller, Hans-Peter; Dreyhaupt, Jens; Gorges, Martin; Ludolph, Albert C; Kassubek, Jan

    2015-03-01

    Diffusion tensor imaging (DTI) for assessing ALS-associated white matter alterations has still not reached the level of a neuroimaging biomarker. Since large-scale multicentre DTI studies in ALS may be hampered by differences in scanning protocols, an approach for pooling of DTI data acquired with different protocols was investigated. Three hundred and nine datasets from 170 ALS patients and 139 controls were collected ex post facto from a monocentric database reflecting different scanning protocols. A 3D correction algorithm was introduced for a combined analysis of DTI metrics despite different acquisition protocols, with the focus on the CST as the tract correlate of ALS neuropathological stage 1. A homogenous set of data was obtained by application of 3D correction matrices. Results showed that a fractional anisotropy (FA) threshold of 0.41 could be defined to discriminate ALS patients from controls (sensitivity/specificity, 74%/72%). For the remaining test sample, sensitivity/specificity values of 68%/74% were obtained. In conclusion, the objective was to merge data recorded with different DTI protocols with 3D correction matrices for analyses at group level. These post processing tools might facilitate analysis of large study samples in a multicentre setting for DTI analysis at group level to aid in establishing DTI as a non-invasive biomarker for ALS.

  11. Relating functional changes during hand movement to clinical parameters in patients with multiple sclerosis in a multi-centre fMRI study

    NARCIS (Netherlands)

    Wegner, C.; Filippi, M.; Korteweg, T.; Beckmann, C.; Ciccarelli, O.; De Stefano, N.; Enzinger, C.; Fazekas, F.; Agosta, F.; Gass, A.; Hirsch, J.; Johansen-Berg, H.; Kappos, L.; Barkhof, F.; Polman, C.H.; Mancini, L.; Manfredonia, F.; Marino, S.; Miller, D. H.; Montalban, X.; Palace, J.; Rocca, M.; Ropele, S.; Rovira, A.; Smith, S.; Thompson, A.; Thornton, J.; Yousry, T.; Matthews, P.M.

    2008-01-01

    We performed a prospective multi-centre study using functional magnetic resonance imaging (fMRI) to better characterize the relationships between clinical expression and brain function in patients with multiple sclerosis (MS) at eight European sites (56 MS patients and 60 age-matched, healthy

  12. Invasive Candida infections in surgical patients in intensive care units: a prospective, multicentre survey initiated by the European Confederation of Medical Mycology (ECMM) (2006-2008)

    NARCIS (Netherlands)

    Klingspor, L.; Tortorano, A.M.; Peman, J.; Willinger, B.; Hamal, P.; Sendid, B.; Velegraki, A.; Kibbler, C.; Meis, J.F.G.M.; Sabino, R.; Ruhnke, M.; Arikan-Akdagli, S.; Salonen, J.; Doczi, I.

    2015-01-01

    A prospective, observational, multicentre study of invasive candidosis (IC) in surgical patients in intensive care units (ICUs) was conducted from 2006 to 2008 in 72 ICUs in 14 European countries. A total of 779 patients (62.5% males, median age 63 years) with IC were included. The median rate of

  13. Image acquisition and interpretation criteria for Tc-99m-HMPAO-labelled white blood cell scintigraphy : results of a multicentre study

    NARCIS (Netherlands)

    Erba, Paola A.; Glaudemans, Andor W. J. M.; Veltman, Niels C.; Sollini, Martina; Pacilio, Marta; Galli, Filippo; Dierckx, Rudi A. J. O.; Signore, Alberto

    Purpose There is no consensus yet on the best protocol for planar image acquisition and interpretation of radiolabelled white blood cell (WBC) scintigraphy. This may account for differences in reported diagnostic accuracy amongst different centres. Methods This was a multicentre retrospective study

  14. Multicentre validation of 4-well azole agar plates as a screening method for detection of clinically relevant azole-resistant Aspergillus fumigatus

    DEFF Research Database (Denmark)

    Arendrup, Maiken Cavling; Verweij, Paul E; Mouton, Johan W

    2017-01-01

    Objectives: Azole-resistant Aspergillus fumigatus is emerging worldwide. Reference susceptibility testing methods are technically demanding and no validated commercial susceptibility tests for moulds currently exist. In this multicentre study a 4-well azole-containing screening agar method was ev...

  15. Tolerability of the capsaicin 8% patch following pretreatment with lidocaine or tramadol in patients with peripheral neuropathic pain: A multicentre, randomized, assessor-blinded study

    NARCIS (Netherlands)

    Jensen, T.S.; Hoye, K.; Fricova, J.; Vanelderen, P.J.L.; Ernault, E.; Siciliano, T.; Marques, S.

    2014-01-01

    BACKGROUND: Application of the capsaicin 8% patch is associated with treatment-related discomfort. Consequently, pretreatment for 60 min with anaesthetic cream is recommended; however, this may be uncomfortable and time consuming. METHODS: We conducted a multicentre, randomized (1:1),

  16. Effects of long-term exposure to air pollution on natural-cause mortality : an analysis of 22 European cohorts within the multicentre ESCAPE project

    NARCIS (Netherlands)

    Beelen, Rob; Raaschou-Nielsen, Ole; Stafoggia, Massimo; Andersen, Zorana Jovanovic; Weinmayr, Gudrun; Hoffmann, Barbara; Wolf, Kathrin; Samoli, Evangelia; Fischer, Paul; Nieuwenhuijsen, Mark; Vineis, Paolo; Xun, Wei W.; Katsouyanni, Klea; Dimakopoulou, Konstantina; Oudin, Anna; Forsberg, Bertil; Modig, Lars; Havulinna, Aki S.; Lanki, Timo; Turunen, Anu; Oftedal, Bente; Nystad, Wenche; Nafstad, Per; De Faire, Ulf; Pedersen, Nancy L.; Ostenson, Claes-Goeran; Fratiglioni, Laura; Penell, Johanna; Korek, Michal; Pershagen, Goeran; Eriksen, Kirsten Thorup; Overvad, Kim; Ellermann, Thomas; Eeftens, Marloes; Peeters, Petra H.; Meliefste, Kees; Wang, Meng; Bueno-de-Mesquita, Bas; Sugiri, Dorothea; Kraemer, Ursula; Heinrich, Joachim; de Hoogh, Kees; Key, Timothy; Peters, Annette; Hampel, Regina; Concin, Hans; Nagel, Gabriele; Ineichen, Alex; Schaffner, Emmanuel; Probst-Hensch, Nicole; Kuenzli, Nino; Schindler, Christian; Schikowski, Tamara; Adam, Martin; Phuleria, Harish; Vilier, Alice; Clavel-Chapelon, Francoise; Declercq, Christophe; Grioni, Sara; Krogh, Vittorio; Tsai, Ming-Yi; Ricceri, Fulvio; Sacerdote, Carlotta; Galassi, Claudia; Migliore, Enrica; Ranzi, Andrea; Cesaroni, Giulia; Badaloni, Chiara; Forastiere, Francesco; Tamayo, Ibon; Amiano, Pilar; Dorronsoro, Miren; Katsoulis, Michail; Trichopoulou, Antonia; Brunekreef, Bert; Hoek, Gerard

    2014-01-01

    Background Few studies on long-term exposure to air pollution and mortality have been reported from Europe. Within the multicentre European Study of Cohorts for Air Pollution Effects (ESCAPE), we aimed to investigate the association between natural-cause mortality and long-term exposure to several

  17. CT scan-evaluated outcome of pulsed electromagnetic fields in the treatment of acute scaphoid fractures: a randomised, multicentre, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Hannemann, P.F.; van Wezenbeek, M.R.; Kolkman, K.A.; Twiss, E.L.; Berghmans, C.H.; Dirven, P.A.; Brink, P.R.; Poeze, M.

    2014-01-01

    We hypothesised that the use of pulsed electromagnetic field (PEMF) bone growth stimulation in acute scaphoid fractures would significantly shorten the time to union and reduce the number of nonunions in a randomised, double-blind, placebo-controlled multicentre trial. A total of 102 patients (78

  18. Recombinant LH supplementation to recombinant FSH during the final days of controlled ovarian stimulation for in vitro fertilization. A multicentre, prospective, randomized, controlled trial

    DEFF Research Database (Denmark)

    Nyboeandersen, A.; Humaidan, P.; Fried, G.

    2008-01-01

    BACKGROUND: The purpose of this multicentre, multinational trial was to study whether rLH supplementation to recombinant FSH (rFSH) during the late follicular phase increased pregnancy rates. METHODS: After down-regulation with nafarelin, 526 women were randomized on Day 1 of stimulation to use...

  19. The feasibility of wireless capsule endoscopy in detecting small intestinal pathology in children under the age of 8 years: a multicentre European study

    NARCIS (Netherlands)

    Fritscher-Ravens, A.; Scherbakov, P.; Bufler, P.; Torroni, F.; Ruuska, T.; Nuutinen, H.; Thomson, M.; Tabbers, M.; Milla, P.

    2009-01-01

    To systematically evaluate the feasibility and methodology to carry out wireless capsule endoscopy (WCE) in children <8 years to define small intestinal pathology. Prospective European multicentre study with negative prior investigation. Patients and 83 children aged 1.5-7.9 years were recruited.

  20. The impact of study design and diagnostic approach in a large multi-centre ADHD study: Part 2: Dimensional measures of psychopathology and intelligence

    NARCIS (Netherlands)

    Muller, U.C.; Asherson, P.; Banaschewski, T.; Buitelaar, J.K.; Ebstein, R.P.; Eisenberg, J.; Gill, M.; Manor, I.; Miranda, A.; Oades, R.D.; Roeyers, H.; Rothenberger, A.; Sergeant, J.A.; Sonuga-Barke, E.J.S.; Thompson, M.; Faraone, S.V.; Steinhausen, H.C.

    2011-01-01

    BACKGROUND: The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with ADHD and 1446

  1. Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid)--a double-blind, randomised, multicentre study in adults

    DEFF Research Database (Denmark)

    Klek, Stanislaw; Chambrier, Cecile; Singer, Pierre

    2013-01-01

    The aim of this study was to evaluate the safety and tolerance of a soybean/MCT/olive/fish oil emulsion in intestinal failure patients on long-term parenteral nutrition. 73 patients took part in a randomized, double-blind, multi-centre study. The study demonstrates that the lipid emulsion...

  2. Comparative activity of tigecycline and tetracycline on Gram-negative and Gram-positive bacteria revealed by a multicentre study in four North European countries

    DEFF Research Database (Denmark)

    Nilsson, Lennart E; Frimodt-Møller, Niels; Vaara, Martti

    2011-01-01

    This study involves a multicentre surveillance of tigecycline and tetracycline activity against Gram-negative and Gram-positive bacteria from primary care centres (PCCs), general hospital wards (GHWs) and intensive care units (ICUs) in Denmark (n = 9), Finland (n = 10), Norway (n = 7) and Sweden (n...

  3. Optimisation of metabolic criteria in the prognostic assessment in patients with lymphoma. A multicentre study.

    Science.gov (United States)

    Del Puig Cózar-Santiago, M; García-Garzón, J R; Moragas-Freixa, M; Soler-Peter, M; Bassa Massanas, P; Sánchez-Delgado, M; Sanchez-Jurado, R; Aguilar-Barrios, J E; Sanz-Llorens, R; Ferrer-Rebolleda, J

    To compare sensitivity, specificity and predictive value of Deauville score (DS) vs. ΔSUVmax in interim-treatment PET (iPET) and end-treatment PET (ePET), in patients with diffuse large B cell lymphoma (DLBCL), Hodgkin lymphoma (HL), and follicular lymphoma (FL). Retrospective longitudinal multicentre study including 138 patients (46 DLBCL, 46 HL, 46 FL), on whom 3 18 F-FDG PET/CT were performed: baseline, iPET, and ePET. Visual (DS) and semi-quantitative (ΔSUVmax) parameters were determined for iPET and ePET. Predictive value was determined in relation to disease-free interval. Statistical analysis. iPET for DLBCL, HL, and FL: 1) sensitivity of DS: 76.92/83.33/61.53%; specificity: 78.78/85/81.81%; 2) sensitivity of ΔSUVmax: 53.84/83.33/61.53%; specificity: 87.87/87.50/78.78%. ePET for DLBCL, HL and FL: 1) sensitivity of DS: 61.53/83.33/69.23%; specificity: 90.90/85/87.87%; 2) sensitivity of ΔSUVmax: 69.23/83.33/69.23%; specificity: 90.90/87.50/84.84%. Predictive assessment. iPET study: in DLBCL, DS resulted in 10.3% recurrence of negative iPET, and 17.1% in ΔSUVmax at disease-free interval; in HL, both parameters showed a 2.8% recurrence of negative iPET; in FL, DS resulted in 15.6% recurrence of negative iPET, and 16.1% in ΔSUVmax, with no statistical significance. ePET study: in DLBCL, DS resulted in 14.3% recurrence of negative ePET, and 11.8% in ΔSUVmax at disease-free interval; in HL and FL, both methods showed 2.8 and 12.5% recurrence in negative ePET, respectively. DS and ΔSUVmax did not show significant differences in DLBCL, HL and FL. Their predictive value also did not show significant differences in HL and FL. In DLBCL, DS was higher in iPET, and ΔSUVmax in ePET. Copyright © 2017 Elsevier España, S.L.U. y SEMNIM. All rights reserved.

  4. Utility of CSF biomarkers in psychiatric disorders: a national multicentre prospective study.

    Science.gov (United States)

    Paquet, Claire; Magnin, Eloi; Wallon, David; Troussière, Anne-Cécile; Dumurgier, Julien; Jager, Alain; Bellivier, Frank; Bouaziz-Amar, Elodie; Blanc, Frédéric; Beaufils, Emilie; Miguet-Alfonsi, Carole; Quillard, Muriel; Schraen, Susanna; Pasquier, Florence; Hannequin, Didier; Robert, Philippe; Hugon, Jacques; Mouton-Liger, François

    2016-06-13

    Affective and psychotic disorders are mental or behavioural patterns resulting in an inability to cope with life's ordinary demands and routines. These conditions can be a prodromal event of Alzheimer's disease (AD). The prevalence of underlying AD lesions in psychiatric diseases is unknown, and it would be helpful to determine them in patients. AD cerebrospinal fluid (CSF) biomarkers (amyloid β, tau and phosphorylated tau) have high diagnostic accuracy, both for AD with dementia and to predict incipient AD (mild cognitive impairment due to AD), and they are sometimes used to discriminate psychiatric diseases from AD. Our objective in the present study was to evaluate the clinical utility of CSF biomarkers in a group of patients with psychiatric disease as the main diagnosis. In a multicentre prospective study, clinicians filled out an anonymous questionnaire about all of their patients who had undergone CSF biomarker evaluation. Before and after CSF biomarker results were obtained, clinicians provided a diagnosis with their level of confidence and information about the treatment. We included patients with a psychiatric disorder as the initial diagnosis. In a second part of the study conducted retrospectively in a followed subgroup, clinicians detailed the psychiatric history and we classified patients into three categories: (1) psychiatric symptoms associated with AD, (2) dual diagnosis and (3) cognitive decline not linked to a neurodegenerative disorder. Of 957 patients, 69 had an initial diagnosis of a psychiatric disorder. Among these 69 patients, 14 (20.2 %) had a CSF AD profile, 5 (7.2 %) presented with an intermediate CSF profile and 50 (72.4 %) had a non-AD CSF profile. Ultimately, 13 (18.8 %) patients were diagnosed with AD. We show that in the AD group psychiatric symptoms occurred later and the delay between the first psychiatric symptoms and the cognitive decline was shorter. This study revealed that about 20 % of patients with a primary

  5. A multicentre molecular analysis of hepatitis B and blood-borne virus coinfections in Viet Nam.

    Directory of Open Access Journals (Sweden)

    Linda Dunford

    Full Text Available Hepatitis B (HBV infection is endemic in Viet Nam, with up to 8.4 million individuals estimated to be chronically infected. We describe results of a large, multicentre seroepidemiological and molecular study of the prevalence of HBV infection and blood-borne viral coinfections in Viet Nam. Individuals with varying risk factors for infection (n = 8654 were recruited from five centres; Ha Noi, Hai Phong, Da Nang, Khanh Hoa and Can Tho. A mean prevalence rate of 10.7% was observed and levels of HBsAg were significantly higher in injecting drug users (IDUs (17.4%, n = 174/1000 and dialysis patients (14.3%, n = 82/575 than in lower-risk groups (9.4%; p<0.001. Coinfection with HIV was seen in 28% of HBV-infected IDUs (n = 49/174 and 15.2% of commercial sex workers (CSWs; n = 15/99. HCV infection was present in 89.8% of the HBV-HIV coinfected IDUs (n = 44/49 and 40% of HBV-HIV coinfected CSWs (n = 16/40. Anti-HDV was detected in 10.7% (n = 34/318 of HBsAg positive individuals. Phylogenetic analysis of HBV S gene (n = 187 showed a predominance of genotype B4 (82.6%; genotypes C1 (14.6%, B2 (2.7% and C5 (0.5% were also identified. The precore mutation G1896A was identified in 35% of all specimens, and was more frequently observed in genotype B (41% than genotype C (3%; p<0.0001. In the immunodominant 'a' region of the surface gene, point mutations were identified in 31% (n = 58/187 of sequences, and 2.2% (n = 4/187 and 5.3% (n = 10/187 specimens contained the major vaccine escape mutations G145A/R and P120L/Q/S/T, respectively. 368 HBsAg positive individuals were genotyped for the IL28B SNP rs12979860 and no significant association between the IL28B SNP and clearance of HBsAg, HBV viral load or HBeAg was observed. This study confirms the high prevalence of HBV infection in Viet Nam and also highlights the significant levels of blood-borne virus coinfections, which have important implications for hepatitis-related morbidity and development of effective

  6. A randomised multicentre trial of CHART versus conventional radiotherapy in head and neck cancer

    International Nuclear Information System (INIS)

    Dische, Stanley; Saunders, Michele; Barrett, Ann; Harvey, Angela; Gibson, Della; Parmar, Mahesh

    1997-01-01

    Background and purpose: Continuous, hyperfractionated, accelerated radiotherapy (CHART) has shown promise of improved tumour control and reduced late morbidity in pilot studies and has now been tested in a multicentre randomised controlled clinical trial. Material and methods: Patients with squamous cell cancer in the main sites within the head and neck region with the general exception of early T1 N0 tumours were entered into the study by 11 centres. There was a 3:2 randomisation to either CHART, where a dose of 54 Gy was given in 36 fractions over 12 days, or to conventional therapy where 66 Gy was given in 33 fractions over 6.5 weeks. A total of 918 patients were included over a 5 year period from March 1990. Results: Acute Morbidity: Acute radiation mucositis was more severe with CHART, occurred earlier but settled sooner and was in nearly all cases healed by 8 weeks in both arms. Skin reactions were less severe and settled more quickly in the CHART treated patients. Tumour control and survival: Life table analyses of loco-regional control, primary tumour control, nodal control, disease-free interval, freedom from metastasis and survival showed no evidence of differences between the two arms. In exploratory subgroup analyses there was evidence of a greater response to CHART in younger patients (P = 0.041) and poorly differentiated tumours appeared to fare better with conventional radiotherapy (P = 0.030). In the larynx there was evidence of a trend towards increasing benefit with more advanced T stage (P = 0.002). Late treatment related morbidity: Osteoradionecrosis occurred in 0.4% of patients after CHART and 1.4% of patients after conventional radiotherapy. The incidence of chondritis or cartilage necrosis was similar in both arms. Life table analysis showed evidence of reduced severity in a number of late morbidities in favour of CHART. These were most striking for skin telangiectasia, superficial and deep ulceration of the mucosa and laryngeal oedema

  7. Week 96 results of the randomized, multicentre Maraviroc Switch (MARCH) study.

    Science.gov (United States)

    Pett, S L; Amin, J; Horban, A; Andrade-Villanueva, J; Losso, M; Porteiro, N; Madero, J S; Belloso, W; Tu, E; Silk, D; Kelleher, A; Harrigan, R; Clark, A; Sugiura, W; Wolff, M; Gill, J; Gatell, J; Clarke, A; Ruxrungtham, K; Prazuck, T; Kaiser, R; Woolley, I; Alberto Arnaiz, J; Cooper, D; Rockstroh, J K; Mallon, P; Emery, S

    2018-01-01

    The Maraviroc Switch (MARCH) study week 48 data demonstrated that maraviroc, a chemokine receptor-5 (CCR5) inhibitor, was a safe and effective switch for the ritonavir-boosted protease inhibitor (PI/r) component of a two nucleos(t)ide reverse transcriptase inhibitor [N(t)RTI] plus PI/r-based antiretroviral regimen in patients with R5-tropic virus. Here we report the durability of this finding. MARCH, an international, multicentre, randomized, 96-week open-label switch study, enrolled HIV-1-infected adults with R5-tropic virus who were stable (> 24 weeks) and virologically suppressed [plasma viral load (pVL) < 50 HIV-1 RNA copies/mL]. Participants were randomized to continue their current PI/r-based regimen (PI/r) or to switch to MVC plus two N(t)RTIs (MVC) (1:2 randomization). The primary endpoint was the difference in the proportion with pVL < 200 copies/mL at 96 weeks. The switch arm was defined as noninferior if the lower limit of the 95% confidence interval (CI) for the difference was < -12% in the intention-to-treat (ITT) population. Safety endpoints (the difference in the mean change from baseline or a comparison of proportions) were analysed as key secondary endpoints. Eighty-two (PI/r) and 156 (MVC) participants were randomized and included in the ITT analysis; 71 (87%) and 130 (83%) were in follow-up and on therapy at week 96. At week 96, 89.0% and 90.4% in the PI/r and MVC arms, respectively, had pVL < 50 copies/mL (95% CI -6.6, 10.2). Moreover, in those switching away from PI/r, there were significant reductions in mean total cholesterol (differences 0.31 mmol/L; P = 0.02) and triglycerides (difference 0.44 mmol/L; P < 0.001). Changes in CD4 T-cell count, renal function, and serious and nonserious adverse events were similar in the two arms. MVC as a switch for a PI/r is safe and effective at maintaining virological suppression while having significant lipid benefits over 96 weeks. © 2017 British HIV Association.

  8. Exploring venlafaxine pharmacokinetic variability with a phenotyping approach, a multicentric french-swiss study (MARVEL study).

    Science.gov (United States)

    Lloret-Linares, Célia; Daali, Youssef; Chevret, Sylvie; Nieto, Isabelle; Molière, Fanny; Courtet, Philippe; Galtier, Florence; Richieri, Raphaëlle-Marie; Morange, Sophie; Llorca, Pierre-Michel; El-Hage, Wissam; Desmidt, Thomas; Haesebaert, Frédéric; Vignaud, Philippe; Holtzmann, Jerôme; Cracowski, Jean-Luc; Leboyer, Marion; Yrondi, Antoine; Calvas, Fabienne; Yon, Liova; Le Corvoisier, Philippe; Doumy, Olivier; Heron, Kyle; Montange, Damien; Davani, Siamak; Déglon, Julien; Besson, Marie; Desmeules, Jules; Haffen, Emmanuel; Bellivier, Frank

    2017-11-07

    It is well known that the standard doses of a given drug may not have equivalent effects in all patients. To date, the management of depression remains mainly empirical and often poorly evaluated. The development of a personalized medicine in psychiatry may reduce treatment failure, intolerance or resistance, and hence the burden and costs of mood depressive disorders. The Geneva Cocktail Phenotypic approach presents several advantages including the "in vivo" measure of different cytochromes and transporter P-gp activities, their simultaneous determination in a single test, avoiding the influence of variability over time on phenotyping results, the administration of low dose substrates, a limited sampling strategy with an analytical method developed on DBS analysis. The goal of this project is to explore the relationship between the activity of drug-metabolizing enzymes (DME), assessed by a phenotypic approach, and the concentrations of Venlafaxine (VLX) + O-demethyl-venlafaxine (ODV), the efficacy and tolerance of VLX. This study is a multicentre prospective non-randomized open trial. Eligible patients present a major depressive episode, MADRS over or equal to 20, treatment with VLX regardless of the dose during at least 4 weeks. The Phenotype Visit includes VLX and ODV concentration measurement. Following the oral absorption of low doses of omeprazole, midazolam, dextromethorphan, and fexofenadine, drug metabolizing enzymes activity is assessed by specific metabolite/probe concentration ratios from a sample taken 2 h after cocktail administration for CYP2C19, CYP3A4, CYP2D6; and by the determination of the limited area under the curve from the capillary blood samples taken 2-3 and 6 h after cocktail administration for CYP2C19 and P-gp. Two follow-up visits will take place between 25 and 40 days and 50-70 days after inclusion. They include assessment of efficacy, tolerance and observance. Eleven french centres are involved in recruitment, expected to be

  9. Chikungunya infection in India: results of a prospective hospital based multi-centric study.

    Directory of Open Access Journals (Sweden)

    Pratima Ray

    Full Text Available BACKGROUND: Chikungunya (CHIKV has recently seen a re-emergence in India with high morbidity. However, the epidemiology and disease burden remain largely undetermined. A prospective multi-centric study was conducted to evaluate clinical, epidemiological and virological features of chikugunya infection in patients with acute febrile illness from various geographical regions of India. METHODS AND FINDINGS: A total of 540 patients with fever of up to 7 days duration were enrolled at Karnataka Institute of Medical Sciences (KIMS, Karnataka (South; Sawai Man Singh Medical College (SMS Rajasthan (West, and All India Institute of Medical Sciences (AIIMS New Delhi (North from June 2008 to May 2009. Serum specimens were screened for chikungunya infection concurrently through RT-PCR and serology (IgM. Phylogenetic analysis was performed using Bioedit and Mega2 programs. Chikungunya infection was detected in 25.37% patients by RT-PCR and/or IgM-ELISA. Highest cases were detected in south (49.36% followed by west (16.28% and north (0.56% India. A difference in proportion of positives by RT-PCR/ELISA with regard to duration of fever was observed (p<0.05. Rashes, joint pain/swelling, abdominal pain and vomiting was frequently observed among chikungunya confirmed cases (p<0.05. Adults were affected more than children. Anti-CHIK antibodies (IgM were detected for more than 60 days of fever onset. Phylogenetic analysis based on E1 gene from KIMS patients (n = 15 revealed ∼99% homology clustering with Central/East African genotype. An amino acid change from lysine to glutamine at position 132 of E1 gene was frequently observed among strains infecting children. CONCLUSIONS: The study documented re-emergence of chikungunya in high frequencies and severe morbidity in south and west India but rare in north. The study emphasizes the need for continuous surveillance for disease burden using multiple diagnostic tests and also warrants the need for an appropriate

  10. Recruitment and retention in a multicentre randomised controlled trial in Bell's palsy: A case study

    Directory of Open Access Journals (Sweden)

    Daly Fergus

    2007-03-01

    Full Text Available Abstract Background It is notoriously difficult to recruit patients to randomised controlled trials in primary care. This is particularly true when the disease process under investigation occurs relatively infrequently and must be investigated during a brief time window. Bell's palsy, an acute unilateral paralysis of the facial nerve is just such a relatively rare condition. In this case study we describe the organisational issues presented in setting up a large randomised controlled trial of the management of Bell's palsy across primary and secondary care in Scotland and how we managed to successfully recruit and retain patients presenting in the community. Methods Where possible we used existing evidence on recruitment strategies to maximise recruitment and retention. We consider that the key issues in the success of this study were; the fact that the research was seen as clinically important by the clinicians who had initial responsibility for recruitment; employing an experienced trial co-ordinator and dedicated researchers willing to recruit participants seven days per week and to visit them at home at a time convenient to them, hence reducing missed patients and ensuring they were retained in the study; national visibility and repeated publicity at a local level delivered by locally based principal investigators well known to their primary care community; encouraging recruitment by payment to practices and reducing the workload of the referring doctors by providing immediate access to specialist care; good collaboration between primary and secondary care and basing local investigators in the otolarnygology trial centres Results Although the recruitment rate did not meet our initial expectations, enhanced retention meant that we exceeded our planned target of recruiting 550 patients within the planned time-scale. Conclusion While difficult, recruitment to and retention within multi-centre trials from primary care can be successfully

  11. Cost-of-illness of epilepsy in Italy. Data from a multicentre observational study (Episcreen).

    Science.gov (United States)

    Berto, P; Tinuper, P; Viaggi, S

    2000-02-01

    To investigate the impact of epilepsy in Italy on healthcare resources, producing an average cost per patient per year of follow-up. The Episcreen Project is a multicentre longitudinal Italian observational study; its methodology, organisational network and case report form have been reported in detail elsewhere. Using a subset of patients with epilepsy from this project, we conducted a retrospective cost-of-illness analysis based on clinical records. The analysis was performed from the societal (community) perspective, including both direct and indirect costs. Hospital admissions, day-hospital visits, specialist visits, instrumental examinations, drugs and productivity losses because of visits and hospitalisation were analysed. Each cost variable was valued in 1996 Italian liras (L) using published national tariffs (except for drugs for which published prices were used). A sensitivity analysis was conducted on indirect costs to test the robustness of the assumption that 1 working day lost for each day hospital visit would produce a change of 0.3% in the weight of indirect costs. Patients analysed in this study were registered in the Episcreen database as at 21 November 1996. They were diagnosed with epilepsy at the last visit, had at least 1 follow-up visit (i.e. at least 1 visit after the enrolment visit), and had at least 12 months of follow-up. The average cost per patient per year was L2,726,116 ($US1767). The average cost per patient was higher for children than for adults [L3,629,997 ($US2353) and L2,362,134 ($US1531), respectively), and for newly diagnosed patients for whom the first diagnosis of epilepsy was addressed at the first Episcreen visit [adults: old referrals L1,304,353 ($US845), new referrals L6,901,374 ($US4473); children: old referrals L2,810,504 ($US1822), new referrals L7,814,400 ($US5065)]. Direct costs represented 87.6% of total costs. The major cost driver was hospitalisation (63.7%), followed by drugs (10.5%), day-hospital visits (4

  12. At-Risk Phenotype of Neurofibromatose-1 Patients: A Multicentre Case-Control Study

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    Ferkal Salah

    2011-07-01

    Full Text Available Abstract Objectives To assess associations between subcutaneous neurofibromas (SC-NFs and internal neurofibromas in patients with neurofibromatosis type 1 (NF-1 and to determine whether the association between SC-NFs and peripheral neuropathy was ascribable to internal neurofibromas. Patients and methods Prospective multicentre case-control study. Between 2005 and 2008, 110 NF-1 adults having two or more SC-NFs were individually matched for age, sex and hospital with 110 controls who had no SC-NF. Patients underwent standardized MRI of the spinal cord, nerve roots and sciatic nerves and an electrophysiological study. Analyses used adjusted multinomial logistic regression (ORa to estimate the risk of the presence of internal neurofibromas or peripheral neuropathies associated with patients presented 2 to 9 SC-NFs, at least 10 SC-NFs as compared to patients without any (referential category. Results Cases had a mean age of 41 (± 13 years; 85 (80% had two to nine SC-NFs and 21 (19% at least ten SC-NFs. SC-NFs were more strongly associated with internal neurofibromas in patients with ten or more SC-NFs than in patients with fewer NF-SCs (e.g., sciatic nerve, aOR = 29.1 [8.5 to 100] vs. 4.3 [2.1 to 9.0]. The association with SC-NFs was stronger for diffuse, intradural, and > 3 cm internal neurofibromas than with other internal neurofibromas. Axonal neuropathy with slowed conduction velocities (SCV was more strongly associated with having at least ten SC-NFs (aOR = 29.9, 5.5 to 162.3 than with having fewer SC-NFs (aOR = 4.4, 0.9 to 22.0. Bivariate analyses showed that the association between axonal neuropathy with SCV and sciatic neurofibromas was mediated by the association between SC-NFs and sciatic neurofibromas. Conclusion The at-risk phenotype of NF-1 patients (i.e. NF-1 patients with SC-NFs is ascribable to associations linking SC-NFs to internal neurofibromas at risk for malignant transformation and to axonal neuropathies with slowed

  13. Patient’s satisfaction after 2-piece inflatable penile prosthesis implantation: An Italian multicentric study

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    Giorgio Gentile

    2016-03-01

    Full Text Available Introduction: Penile prosthesis implant represents a valuable solution for pts with severe erectile dysfunction (ED, non-responders to medical management. The aim of our study was to evaluate the satisfaction of patients (pts after 2-pieces inflatable penile prosthesis (IPP. Aim of the study: to evaluate safety, reliability and post-operative patient’s satisfaction after implantation of two-pieces IPP. Materials and Methods: This retrospective multicentric analysis concerns a group of 42 patients undergone 2-pieces IPP implantation from November 2005 to November 2013, in four Centers of proven experience. As a first step, a detailed review of all clinical reports was performed. Secondly, every patient was asked to fill the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS specifically modified, in order to assess their own satisfaction after surgery and, its impact on patient’s quality of sexual life. Results: 42 pts were evaluated (AMS-Ambicor: 28; Coloplast- Excell: 14; mean age, at time of operation: 60,7 years; mean follow up: 27,6 months; etiology of ED: vascular 23,8%, diabetes 19%, La Peyronie D. 7,1%, consequence of radical prostatectomy 31%, consequence of other pelvic surgery 11,9%, spinal trauma 7%. Mean operative time: 117 ± 58 min, mean postoperative hospital stay 3 ± 1,6 days. Post operative short-term complications: 4 pts (9,5%. Post operative long-term complications: 4 pts (9,5%. Long-term functional results (Questionnaire: 71% of pts (30 reported regular use of the prosthesis, at least 1 time/week, the satisfaction was good in 42% of pts (18, quite good in 33,3% (14, quite bad in 2,4% (1, very bad in 7,1% (3, 6 pts (14,4% didn’t answer. Conclusions: 2 pieces IPP appears to be associated with a low complication rate and good satisfaction of pts especially in the elderly. It also assures satisfactory rates of aesthetics and functional results.

  14. Incretin based drugs and the risk of pancreatic cancer: international multicentre cohort study

    Science.gov (United States)

    Filion, Kristian B; Platt, Robert W; Dahl, Matthew; Dormuth, Colin R; Clemens, Kristin K; Durand, Madeleine; Juurlink, David N; Targownik, Laura E; Turin, Tanvir C; Paterson, J Michael; Ernst, Pierre

    2016-01-01

    Objective To determine whether the use of incretin based drugs compared with sulfonylureas is associated with an increased risk of incident pancreatic cancer in people with type 2 diabetes. Design Population based cohort. Setting Large, international, multicentre study combining the health records from six participating sites in Canada, the United States, and the United Kingdom. Participants A cohort of 972 384 patients initiating antidiabetic drugs between 1 January 2007 and 30 June 2013, with follow-up until 30 June 2014. Main outcome measures Within each cohort we conducted nested case-control analyses, where incident cases of pancreatic cancer were matched with up to 20 controls on sex, age, cohort entry date, duration of treated diabetes, and duration of follow-up. Hazard ratios and 95% confidence intervals for incident pancreatic cancer were estimated, comparing use of incretin based drugs with use of sulfonylureas, with drug use lagged by one year for latency purposes. Secondary analyses assessed whether the risk varied by class (dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonists) or by duration of use (cumulative duration of use and time since treatment initiation). Site specific hazard ratios were pooled using random effects models. Results During 2 024 441 person years of follow-up (median follow-up ranging from 1.3 to 2.8 years; maximum 8 years), 1221 patients were newly diagnosed as having pancreatic cancer (incidence rate 0.60 per 1000 person years). Compared with sulfonylureas, incretin based drugs were not associated with an increased risk of pancreatic cancer (pooled adjusted hazard ratio 1.02, 95% confidence interval 0.84 to 1.23). Similarly, the risk did not vary by class and evidence of a duration-response relation was lacking. Conclusions In this large, population based study the use of incretin based drugs was not associated with an increased risk of pancreatic cancer compared with sulfonylureas

  15. Causes and outcomes of sepsis in southeast Asia: a multinational multicentre cross-sectional study.

    Science.gov (United States)

    2017-02-01

    Improved understanding of pathogens that cause sepsis would aid management and antimicrobial selection. In this study, we aimed to identify the causative pathogens of sepsis in southeast Asia. In this multinational multicentre cross-sectional study of community-acquired sepsis and severe sepsis, we prospectively recruited children (age ≥30 days and sepsis according to the Surviving Sepsis Campaign 2012, and within 24 h of admission were enrolled. Blood from every patient, and nasopharyngeal swab, urine, stool, and cerebrospinal fluid, if indicated, were collected for reference diagnostic tests to identify causative pathogens. We report causative pathogens of sepsis and 28-day mortality. We also estimate mortality associated with enrolment with severe sepsis. This study was registered with ClinicalTrials.gov, number NCT02157259. From Dec 16, 2013, to Dec 14, 2015, 4736 patients were screened and 1578 patients (763 children and 815 adults) were enrolled. Dengue viruses (n=122 [8%]), Leptospira spp (n=95 [6%]), rickettsial pathogens (n=96 [6%]), Escherichia coli (n=76 [5%]), and influenza viruses (n=65 [4%]) were commonly identified in both age groups; whereas Plasmodium spp (n=12 [1%]) and Salmonella enterica serovar Typhi (n=3 [0·2%]) were rarely observed. Emerging pathogens identified included hantaviruses (n=28 [2%]), non-typhoidal Salmonella spp (n=21 [1%]), Streptococcus suis (n=18 [1%]), Acinetobacter spp (n=12 [1%]), and Burkholderia pseudomallei (n=5 [sepsis was identified on enrolment in 194 (28%) of 731 children and 546 (68%) of 804 adults, and was associated with increased mortality (adjusted odds ratio 5·3, 95% CI 2·7-10·4; pSepsis in southeast Asia is caused by a wide range of known and emerging pathogens, and is associated with substantial mortality. National Cancer Institute, National Institute of Allergy and Infectious Diseases, National Institutes of Health, USA, and Wellcome Trust, UK. Copyright © 2017 The Author(s). Published by Elsevier Ltd

  16. Mechanical supports for acute, severe ankle sprain: a pragmatic, multicentre, randomised controlled trial.

    Science.gov (United States)

    Lamb, S E; Marsh, J L; Hutton, J L; Nakash, R; Cooke, M W

    2009-02-14

    Severe ankle sprains are a common presentation in emergency departments in the UK. We aimed to assess the effectiveness of three different mechanical supports (Aircast brace, Bledsoe boot, or 10-day below-knee cast) compared with that of a double-layer tubular compression bandage in promoting recovery after severe ankle sprains. We did a pragmatic, multicentre randomised trial with blinded assessment of outcome. 584 participants with severe ankle sprain were recruited between April, 2003, and July, 2005, from eight emergency departments across the UK. Participants were provided with a mechanical support within the first 3 days of attendance by a trained health-care professional, and given advice on reducing swelling and pain. Functional outcomes were measured over 9 months. The primary outcome was quality of ankle function at 3 months, measured using the Foot and Ankle Score; analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN37807450. Patients who received the below-knee cast had a more rapid recovery than those given the tubular compression bandage. We noted clinically important benefits at 3 months in quality of ankle function with the cast compared with tubular compression bandage (mean difference 9%; 95% CI 2.4-15.0), as well as in pain, symptoms, and activity. The mean difference in quality of ankle function between Aircast brace and tubular compression bandage was 8%; 95% CI 1.8-14.2, but there were little differences for pain, symptoms, and activity. Bledsoe boots offered no benefit over tubular compression bandage, which was the least effective treatment throughout the recovery period. There were no significant differences between tubular compression bandage and the other treatments at 9 months. Side-effects were rare with no discernible differences between treatments. Reported events (all treatments combined) were cellulitis (two cases), pulmonary embolus (two cases), and

  17. Prescribing patterns in dementia: a multicentre observational study in a German network of CAM physicians

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    Vollmar Horst C

    2011-08-01

    Full Text Available Abstract Background Dementia is a major and increasing health problem worldwide. This study aims to investigate dementia treatment strategies among physicians specialised in complementary and alternative medicine (CAM by analysing prescribing patterns and comparing them to current treatment guidelines in Germany. Methods Twenty-two primary care physicians in Germany participated in this prospective, multicentre observational study. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients had at least one diagnosis of dementia according to the 10th revision of the International Classification of Diseases during the study period. Multiple logistic regression was used to determine factors associated with a prescription of any anti-dementia drug including Ginkgo biloba. Results During the 5-year study period (2004-2008, 577 patients with dementia were included (median age: 81 years (IQR: 74-87; 69% female. Dementia was classified as unspecified dementia (57.2%, vascular dementia (25.1%, dementia in Alzheimer's disease (10.4%, and dementia in Parkinson's disease (7.3%. The prevalence of anti-dementia drugs was 25.6%. The phytopharmaceutical Ginkgo biloba was the most frequently prescribed anti-dementia drug overall (67.6% of all followed by cholinesterase inhibitors (17.6%. The adjusted odds ratio (AOR for receiving any anti-dementia drug was greater than 1 for neurologists (AOR = 2.34; CI: 1.59-3.47, the diagnosis of Alzheimer's disease (AOR = 3.28; CI: 1.96-5.50, neuroleptic therapy (AOR = 1.87; CI: 1.22-2.88, co-morbidities hypertension (AOR = 2.03; CI: 1.41-2.90, and heart failure (AOR = 4.85; CI: 3.42-6.88. The chance for a prescription of any anti-dementia drug decreased with the diagnosis of vascular dementia (AOR = 0.64; CI: 0.43-0.95 and diabetes mellitus (AOR = 0.55; CI: 0.36-0.86. The prescription of Ginkgo biloba was associated with sex (female: AOR = 0.41; CI: 0.19-0.89, patient age (AOR = 1

  18. Chasing the effects of Pre-analytical Confounders - a Multicentre Study on CSF-AD biomarkers

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    Maria Joao Leitao

    2015-07-01

    Full Text Available Core cerebrospinal fluid (CSF biomarkers-Aβ42, Tau and pTau–have been recently incorporated in the revised criteria for Alzheimer’s disease (AD. However, their widespread clinical application lacks standardization. Pre-analytical sample handling and storage play an important role in the reliable measurement of these biomarkers across laboratories. In this study, we aim to surpass the efforts from previous studies, by employing a multicentre approach to assess the impact of less studied CSF pre-analytical confounders in AD-biomarkers quantification. Four different centres participated in this study and followed the same established protocol. CSF samples were analysed for three biomarkers (Aβ42, Tau and pTau and tested for different spinning conditions (temperature: Room temperature (RT vs. 4oC; speed: 500g vs. 2000g vs. 3000g, storage volume variations (25%, 50% and 75% of tube total volume as well as freezing-thaw cycles (up to 5 cyles. The influence of sample routine parameters, inter-centre variability and relative value of each biomarker (reported as normal/abnormal, was analysed. Centrifugation conditions did not influence biomarkers levels, except for samples with a high CSF total protein content, where either non centrifugation or centrifugation at RT, compared to 4ºC, led to higher Aβ42 levels. Reducing CSF storage volume from 75% to 50% of total tube capacity, decreased Aβ42 concentration (within analytical CV of the assay, whereas no change in Tau or pTau was observed. Moreover, the concentration of Tau and pTau appears to be stable up to 5 freeze-thaw cycles, whereas Aβ42 levels decrease if CSF is freeze-thawed more than 3 times. This systematic study reinforces the need for CSF centrifugation at 4ºC prior to storage and highlights the influence of storage conditions in Aβ42 levels. This study contributes to the establishment of harmonized standard operating procedures that will help reducing inter-lab variability of CSF

  19. Brazilian multicentre study on preterm birth (EMIP: prevalence and factors associated with spontaneous preterm birth.

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    Renato Passini

    Full Text Available BACKGROUND: Preterm birth rate is increasing and is currently a worldwide concern. The purpose of this study was to estimate the prevalence of preterm birth in a sample of health facilities in Brazil and to identify the main risk factors associated with spontaneous preterm births. METHODS AND FINDINGS: This was a multicentre cross sectional study on preterm births in 20 referral obstetric hospitals with a case-control component to identify factors associated with spontaneous preterm birth. Surveillance was implemented at all centres to identify preterm births. For eligible consenting women, data were collected through a post-delivery questionnaire completed with information from all mother-newborn medical records until death or discharge or at a maximum of 60 days post-delivery, whichever came first. The risk of spontaneous preterm birth was estimated with OR and 95%CI for several predictors. A non-conditional logistic regression analysis was then performed to identify independently associated factors. The overall prevalence of preterm birth was 12.3%. Among them, 64.6% were spontaneous and 35.4% therapeutic. In the case-control component, 2,682 spontaneous preterm births were compared to a sample of 1,146 term births. Multivariate analyses identified the following as risk factors for spontaneous preterm birth among women with at least one previous birth: a previous preterm birth (ORadj = 3.19, 2.30-4.43, multiple pregnancy (ORadj = 29.06, 8.43-100.2, cervical insufficiency (ORadj = 2.93, 1.07-8.05, foetal malformation (ORadj = 2.63, 1.43-4.85, polyhydramnios (ORadj = 2.30, 1.17-4.54, vaginal bleeding (ORadj = 2.16, 1.50-3.11, and previous abortion (ORadj = 1.39, 1.08-1.78. High BMI (ORadj = 0.94, 0.91-0.97 and weight gain during gestation (ORadj = 0.92, 0.89-0.95 were found to be protective factors. CONCLUSIONS: The preterm birth rate in these health facilities in Brazil is high and spontaneous preterm births

  20. Multicentre survey of radiologically inserted gastrostomy feeding tube (RIG) in the UK

    International Nuclear Information System (INIS)

    Lowe, A.S.; Laasch, H.U.; Stephenson, S.; Butterfield, C.; Goodwin, M.; Kay, C.L.; Glancy, S.; Jackson, S.; Brown, D.; McLean, P.; Keanie, J.; Thrower, A.; Briggs, R.; Punekar, S.; Krishnan, S.; Thomas, B.; Yap, K.; Mullan, D.; Maskell, G.; Hancock, J.

    2012-01-01

    Aims: To evaluate the variance in current UK clinical practice and clinical outcomes for direct percutaneous radiologically inserted gastrostomy (RIG). Materials and methods: A prospective UK multicentre survey of RIG performed between October 2008 and August 2010 was performed through the British Society of Gastrointestinal and Abdominal Radiology (BSGAR). Results: Data from 684 patients were provided by 45 radiologists working at 17 UK centres. Two hundred and sixty-three cases (40%) were performed with loop-retained catheters, and 346 (53%) with balloon-retained devices. Sixty percent of all patients experienced pain in the first 24 h, but settled in the majority thereafter. Early complications, defined as occurring in the first 24 h, included minor bleeding (1%), wound infection (3%), peritonism (2%), and tube misplacement (1%). Late complications, defined as occurring between day 2 and day 30 post-procedure, included mild pain (30%), persisting peritonism (2%), and 30 day mortality of 1% (5/665). Pre-procedural antibiotics or anti-methicillin-resistant Staphylococcus aureus (MRSA) prophylaxis did not affect the rate of wound infection, peritonitis, post-procedural pain, or mortality. Ninety-three percent of cases were performed using gastropexy. Gastropexy decreased post-procedural pain (p < 0.001), but gastropexy-related complications occurred in 5% of patients. However, post-procedure pain increased with the number of gastropexy sutures used (p < 0.001). The use of gastropexy did not affect the overall complication rate or mortality. Post-procedure pain increased significantly as tube size increased (p < 0.001). The use of balloon-retention feeding tubes was associated with more pain than the deployment of loop-retention devices (p < 0.001). Conclusion: RIG is a relatively safe procedure with a mortality of 1%, with or without gastropexy. Pain is the commonest complication. The use of gastropexy, fixation dressing or skin sutures, smaller tube sizes, and

  1. Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial

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    Freeman Liv M

    2012-07-01

    Full Text Available Abstract Background Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments. Methods/design The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia. Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief. Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity, mode of delivery and maternal and neonatal side effects. The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared. Discussion This study, considering cost

  2. Job satisfaction and turnover intention among Iraqi doctors--a descriptive cross-sectional multicentre study.

    Science.gov (United States)

    Ali Jadoo, Saad Ahmed; Aljunid, Syed Mohamed; Dastan, Ilker; Tawfeeq, Ruqiya Subhi; Mustafa, Mustafa Ali; Ganasegeran, Kurubaran; AlDubai, Sami Abdo Radman

    2015-04-19

    During the last two decades, the Iraqi human resources for health was exposed to an unprecedented turnover of trained and experienced medical professionals. This study aimed to explore prominent factors affecting turnover intentions among Iraqi doctors. A descriptive cross-sectional multicentre study was carried out among 576 doctors across 20 hospitals in Iraq using multistage sampling technique. Participants completed a self-administered questionnaire, which included socio-demographic information, work characteristics, the 10-item Warr-Cook-Wall job satisfaction scale, and one question on turnover intention. Descriptive and bivariate and multiple logistic regression analyses were conducted to identify significant factors affecting turnover intentions. More than one half of Iraqi doctors (55.2%) were actively seeking alternative employment. Factors associated with turnover intentions among doctors were low job satisfaction score (odds ratio (OR) = 0.97; 95% confidence interval (CI): 0.95, 0.99), aged 40 years old or less (OR = 2.9; 95% CI: 1.74, 4.75), being male (OR = 4.2; 95% CI: 2.54, 7.03), being single (OR = 5.0; 95% CI: 2.61, 9.75), being threatened (OR = 3.5; 95% CI: 1.80, 6.69), internally displaced (OR = 3.1; 95% CI: 1.43, 6.57), having a perception of unsafe medical practice (OR = 4.1; 95% CI: 1.86, 9.21), working more than 40 h per week, (OR = 2.3; 95% CI: 1.27, 4.03), disagreement with the way manager handles staff (OR = 2.2; 95% CI: 1.19, 4.03), being non-specialist, (OR = 3.9, 95% CI: 2.08, 7.13), and being employed in the government sector only (OR = 2.0; 95% CI: 1.09, 3.82). The high-turnover intention among Iraqi doctors is significantly associated with working and security conditions. An urgent and effective strategy is required to prevent doctors' exodus.

  3. [Introduction of capillary glycosylated haemoglobin determination in a Primary Care Health Area: Multicentre study of the evolution of patients with type 2 diabetes mellitus].

    Science.gov (United States)

    Núñez-Sánchez, M Á; Cervantes-Cuesta, M Á; Brocal-Ibañez, P; Salmeron-Arjona, E; León-Martínez, L P; Cerezo-Sanmartin, M

    The aim of this study was to evaluate the efficiency of a joint intervention that included educational components, self-assessment, and information to optimise diabetes control through the introduction of instant capillary glycosylated haemoglobin (HbA1c) determination in Primary Care. A multicentre prospective descriptive study was carried out over 3years in 10Primary Care Centres of the Area VII Murcia East. At the end of the study there were 804 patients with type 2 diabetes (DM2). Patients were divided into 4 groups based on initial values of HbA1c, and if changes in their treatment were needed. HbA1c, body mass index, and blood pressure were monitored. A financial assessment was also performed on the impact of the implementation of a protocol to measure instant capillary RESULTS: A significant reduction was observed in HbA1c values. The initial HbA1c mean value was 7.4±1.4%, which decreased to a final value of 6.9±1.0% (P<.001). At the end of the study, 71.4% of patients included reached diabetic control objectives. In addition, the financial assessment demonstrated that the implementation of this diabetes control system led to a decrease of the 24.7% in spending on glucose strips after the first year of study in Area VII Murcia Health Service. The introduction of capillary HbA1c determination in Primary Care has demonstrated to improve diabetes control and the efficiency of the health personnel. Furthermore, a reduction in the health costs of patients with DM2 was also shown. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  4. Robot-assisted extravesical ureteral reimplantation (revur) for unilateral vesico-ureteral reflux in children: results of a multicentric international survey.

    Science.gov (United States)

    Esposito, Ciro; Masieri, Lorenzo; Steyaert, Henri; Escolino, Maria; Cerchione, Raffaele; La Manna, Angela; Cini, Chiara; Lendvay, Thomas S

    2018-03-01

    This multicentric international retrospective study aimed to report the outcome of robot-assisted extravesical ureteral reimplantation (REVUR) in patients with unilateral vesico-ureteral reflux (VUR). The medical records of 55 patients (35 girls, 20 boys) underwent REVUR in four international centers of pediatric robotic surgery for primary unilateral VUR were retrospectively reviewed. Patients' average age was 4.9 years. The preoperative grade of reflux was III in 12.7%, IV in 47.3% and V in 40%. Twenty-six patients (47.3%) presented a loss of renal function preoperatively and 10 (18.1%) had a duplex system. Average robot docking time was 16.2 min (range 5-30). Average total operative time was 92.2 min (range 50-170). No conversions or intra-operative complications were recorded. All patients had a bladder Foley catheter for 24 h post-operatively. Average hospital stay was 2 days (range 1-3). Average follow-up length was 28 months (range 9-60). We recorded three (5.4%) postoperative complications: 1 small urinoma resolved spontaneously (II Clavien) and 2 persistent reflux, only one requiring redo-surgery using endoscopic injection (IIIb Clavien). REVUR is a safe and effective technique for treatment of primary unilateral VUR. The procedure is easy and fast to perform thanks to the 6° of freedom of robotic arms. The learning curve is short and it is useful to begin the robotics experience with a surgeon expert in robotic surgery as proctor on the 2nd robot console. The high cost and the diameter of instruments remain the main challenges of robotics applications in pediatric urology.

  5. Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial.

    Science.gov (United States)

    Beukes, Eldré W; Baguley, David M; Allen, Peter M; Manchaiah, Vinaya; Andersson, Gerhard

    2017-04-21

    Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for a U.K. Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and associated comorbidities such as insomnia and depression. The aim of this phase III randomised controlled trial is to compare this new iCBT intervention with an established intervention, namely face-to-face clinical care for tinnitus. This will be a multi-centre study undertaken across three hospitals in the East of England. The design is a randomised, two-arm, parallel-group, non-inferiority trial with a 2-month follow-up. The experimental group will receive the guided iCBT intervention, whereas the active control group will receive the usual face-to-face clinical care. An independent researcher will randomly assign participants, using a computer-generated randomisation schedule, after stratification for tinnitus severity. There will be 46 participants in each group. The primary assessment measure will be the Tinnitus Functional Index. Data analysis will establish whether non-inferiority is achieved using a pre-defined non-inferiority margin. This protocol outlines phase III of a clinical trial comparing a new iCBT with established face-to-face care for tinnitus. If guided iCBT for tinnitus proves to be as effective as the usual tinnitus care, it may be a viable additional management route for individuals with tinnitus. This could increase access to evidence-based effective tinnitus care and reduce the pressures on existing health care systems. ClinicalTrials.gov identifier: NCT02665975 . Registered on 22 January 2016.

  6. The real-world use of regorafenib for metastatic colorectal cancer: multicentre analysis of treatment pattern and outcomes in Hong Kong.

    Science.gov (United States)

    Lam, Ka-On; Lee, Kin-Chung; Chiu, Joanne; Lee, Victor Ho-Fun; Leung, Roland; Choy, T S; Yau, Thomas

    2017-07-01

    To evaluate the benefits and tolerability of regorafenib in the real-world setting, we performed a multicentre analysis in Hong Kong. Individual patient data were retrieved from three leading oncology centres in Hong Kong for analyses. All patients with metastatic colorectal cancer (mCRC) treated with regorafenib after failure of all standard systemic options were included. From July 2013 to December 2015, 45 consecutive patients treated with regorafenib for mCRC were analysed. The median age was 63. Twenty patients were started at 160 mg, while the other 25 patients were started at a lower dose. The median progression-free survival was 15.6 weeks (95% CI 13.1 to 18.1 weeks) and the median overall survival was 30.4 weeks (95% CI 16.6 to 44.3 weeks). Among the 31 evaluable patients, only 1 patient (3.2%) achieved partial response and another 10 patients (32.3%) had stable disease. The commonest grade 3 non-haematological adverse event (AE) was hand-foot skin reaction (26.7%) and the commonest grade 3 or 4 haematological AE was anaemia (8.9%). Notably, patients who were started on a lower dose of regorafenib had significantly lower risk of grade 3 treatment-emergent AEs. Overall, 78.3% of the patients had dose reduction during the first and second cycles. Patients older than 65 years were more likely to experience cycle suspension and require dose reduction. Our study confirmed the efficacy and tolerability of regorafenib in the real-world setting. It also suggested that individualised dosing of regorafenib in patients with mCRC might result in better clinical outcomes. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  7. Variability explained by strength, body composition and gait impairment in activity and participation measures for children with cerebral palsy: a multicentre study.

    Science.gov (United States)

    Oeffinger, Donna; Gorton, George; Hassani, Sahar; Sison-Williamson, Mitell; Johnson, Barbara; Whitmer, Megan; Romness, Mark; Kryscio, Dick; Tylkowski, Chester; Bagley, Anita

    2014-10-01

    To determine the amount of variability in scores on activity and participation measures used to assess ambulatory individuals with cerebral palsy explained by strength, body composition, gait impairment and participant characteristics. Multicentre prospective cross-sectional study. Seven paediatric-orthopaedic specialty hospitals. Three hundred and seventy-seven ambulatory individuals (241 males, 136 females) with cerebral palsy, Gross Motor Function Classification System (GMFCS) levels I-III (I = 148, II = 153, III = 76), ages 8-18 years (mean 12 years 9 months, SD 2 years 8 months). Participants completed assessments of GMFCS level, patient history, lower extremity muscle strength, Gross Motor Function Measure (GMFM-66), Pediatric Outcomes Data Collection Instrument (PODCI), instrumented gait analysis, 1 minute walk test, Timed Up-and-Go and body composition. Multiple linear regression and bootstrap analyses were performed for each outcome measure, stratified by GMFCS level. The amount of variability in outcome measures explained by participant characteristics, strength, and gait impairment ranged from 11% to 50%. Gait impairment was the most common predictor variable and frequently explained the greatest variance across all outcome measures and GMFCS levels. As gait impairment increased, scores on outcome measures decreased. Strength findings were inconsistent and not a primary factor. Body composition contributed minimally (cerebral palsy type, gestational age and age at walking onset), were significant predictor variables in several models. Variability in outcome measure scores is multifaceted and only partially explained by strength and gait impairment illustrating the challenges of attempting to explain variation within this heterogeneous population. Clinicians treating individuals with cerebral palsy should consider this when developing treatment paradigms. © The Author(s) 2014.

  8. Efficacy of night-time compression for breast cancer related lymphedema (LYNC): protocol for a multi-centre, randomized controlled efficacy trial

    International Nuclear Information System (INIS)

    McNeely, Margaret L.; Campbell, Kristin L.; Webster, Marc; Kuusk, Urve; Tracey, Karen; Mackey, John

    2016-01-01

    Lymphedema is a prevalent long-term effect of breast cancer treatment that is associated with reduced quality of life. More recent observational data suggest that the addition of night-time compression to day-time use of a compression garment results in better long-term control of arm lymphedema. The primary objectives of the randomized controlled phase of the trial are to determine the efficacy of night-time compression on arm lymphedema volume maintenance and quality of life in breast cancer survivors who have completed intensive reduction treatment for their lymphedema. The study will be a parallel 3-arm, multi-centre randomized fast-track trial. A total of 120 women with breast cancer related lymphedema will be recruited from 3 centres in Canada and randomized to group 1: Day-time compression garment alone or Group 2: Day-time compression garment + night-time compression bandaging or Group 3: Day-time compression garment + use of a night-time compression system garment. The duration of the primary intervention period will be 12 weeks. The follow-up period after the intervention (weeks 13 to 24) will follow a longitudinal observational design. The primary outcome variables: differences from baseline to week 12 in arm volume and quality of life (Lymphoedema Functioning, Disability and Health Questionnaire: Lymph-ICF). Secondary outcomes include bioimpedance analysis, sleep disturbance and self-efficacy. All measurements are standardized and will be performed prior to randomization, and at weeks 6, 12, 18 and 24. The use of night-time compression as a self-management strategy for chronic breast cancer related lymphedema is seen as an innovative approach to improve long-term control over the condition. This trial aims to advance the knowledge on self-management strategies for lymphedema

  9. ZOOM or Non-ZOOM? Assessing Spinal Cord Diffusion Tensor Imaging Protocols for Multi-Centre Studies.

    Directory of Open Access Journals (Sweden)

    Rebecca S Samson

    Full Text Available The purpose of this study was to develop and evaluate two spinal cord (SC diffusion tensor imaging (DTI protocols, implemented at multiple sites (using scanners from two different manufacturers, one available on any clinical scanner, and one using more advanced options currently available in the research setting, and to use an automated processing method for unbiased quantification. DTI parameters are sensitive to changes in the diseased SC. However, imaging the cord can be technically challenging due to various factors including its small size, patient-related and physiological motion, and field inhomogeneities. Rapid acquisition sequences such as Echo Planar Imaging (EPI are desirable but may suffer from image distortions. We present a multi-centre comparison of two acquisition protocols implemented on scanners from two different vendors (Siemens and Philips, one using a reduced field-of-view (rFOV EPI sequence, and one only using options available on standard clinical scanners such as outer volume suppression (OVS. Automatic analysis was performed with the Spinal Cord Toolbox for unbiased and reproducible quantification of DTI metrics in the white matter. Images acquired using the rFOV sequence appear less distorted than those acquired using OVS alone. SC DTI parameter values obtained using both sequences at all sites were consistent with previous measurements made at 3T. For the same scanner manufacturer, DTI parameter inter-site SDs were smaller for the rFOV sequence compared to the OVS sequence. The higher inter-site reproducibility (for the same manufacturer and acquisition details, i.e. ZOOM data acquired at the two Philips sites of rFOV compared to the OVS sequence supports the idea that making research options such as rFOV more widely available would improve accuracy of measurements obtained in multi-centre clinical trials. Future multi-centre studies should also aim to match the rFOV technique and signal-to-noise ratios in all

  10. Demonstration of the metaphylactic use of gamithromycin against bacterial pathogens associated with bovine respiratory disease in a multicentre farm trial.

    Science.gov (United States)

    Baggott, D; Casartelli, A; Fraisse, F; Manavella, C; Marteau, R; Rehbein, S; Wiedemann, M; Yoon, S

    2011-03-05

    On five commercial cattle rearing sites across Europe, a total of 802 young cattle at high risk of developing bovine respiratory disease (BRD) associated with the bacterial pathogens Mannheimia haemolytica or Pasteurella multocida and/or Mycoplasma bovis were enrolled into a multicentre, controlled field trial. Half were treated with a single dose of gamithromycin at 6 mg/kg bodyweight by subcutaneous injection and half received an injection of a saline placebo as the control. All animals were observed daily for 14 days for signs of BRD as defined by set criteria. The proportion of metaphylactic preventive treatment successes, defined as animals surviving to day 14 without signs of BRD, in the gamithromycin-treated group (86 per cent) was significantly (P=0.0012) higher than in the saline-treated controls (61 per cent). Morbidity among the treated animals was reduced by 64 per cent compared with the controls.

  11. Determinants of Attrition to Follow-Up in a Multicentre Cohort Study in Children-Results from the IDEFICS Study

    DEFF Research Database (Denmark)

    Hense, Sabrina; Pohlabeln, Hermann; Michels, Nathalie

    2013-01-01

    Cohort participant retention is a crucial element and may depend on several factors. Based on data from a multicentre cohort of European children, the effect of baseline participation on attrition and the association with and the impact of single determinants in relation to the extent of attrition......-being (OR = 1.46; 99% CI: 1.19, 1.79) was lacking. Drop-out proportion rose with the number of missing items. Overweight, low education, single parenthood and low well-being scores were independent determinants of attrition. Baseline participation, and the individual determinant effects seemed unrelated...... to the variation of the extent of attrition between study centres. A high level of item nonresponse as well as overweight and disadvantageous sociodemographic conditions were identified as main attrition determinants, suggesting the consideration of these aspects in conduct and analysis of cohort studies...

  12. Results of a national multicentric study on compliance to treatment with various disphosphonate formulations in patients with postmenopausal osteoporosis.

    Science.gov (United States)

    Vinicola, V; Giampà, E; Di Bonito, M; Ferretti, V; Nuvoli, G; Paoletti, F; Piazzini, M; Ranieri, M; Tuveri, M A

    2015-09-01

    Compliance to pharmacological treatment for osteoporosis is crucial if the risk of fracture is to be reduced. Case series show that treatment with traditional bisphosphonates in the form of tablets has a compliance of between approximately 30% and 70%. The aims of this paper were to assess compliance to treatment with various formulations of bisphonates and to identify those at highest risk of discontinuation. In this multicentre retrospective observational study, a population of 387 women diagnosed with postmenopausal osteoporosis under treatment with bisphosphonates (risedronate, ibandronate, alendronate in tablet form, alendronate in a fluid solution per os) was observed for at least a year. Demographic data and information pertaining to the type of drug taken, compliance to treatment, side effects, reasons for discontinuation, the basal examination and follow-up at 18 months and later were recorded. Analysis of patient compliance to a prescribed treatment plan showed a significantly higher persistence (Pmenopause, risked discontinuation.

  13. Demonstration of the metaphylactic use of gamithromycin against bacterial pathogens associated with bovine respiratory disease in a multicentre farm trial

    Science.gov (United States)

    Baggott, D.; Casartelli, A.; Fraisse, F.; Manavella, C.; Marteau, R.; Rehbein, S.; Wiedemann, M.; Yoon, S.

    2011-01-01

    On five commercial cattle rearing sites across Europe, a total of 802 young cattle at high risk of developing bovine respiratory disease (BRD) associated with the bacterial pathogens Mannheimia haemolytica or Pasteurella multocida and/or Mycoplasma bovis were enrolled into a multicentre, controlled field trial. Half were treated with a single dose of gamithromycin at 6 mg/kg bodyweight by subcutaneous injection and half received an injection of a saline placebo as the control. All animals were observed daily for 14 days for signs of BRD as defined by set criteria. The proportion of metaphylactic preventive treatment successes, defined as animals surviving to day 14 without signs of BRD, in the gamithromycin-treated group (86 per cent) was significantly (P=0.0012) higher than in the saline-treated controls (61 per cent). Morbidity among the treated animals was reduced by 64 per cent compared with the controls. PMID:21493573

  14. Serum C-reactive protein concentration as an indicator of remission status in dogs with multicentric lymphoma

    DEFF Research Database (Denmark)

    Nielsen, Lise; Toft, Nils; Eckersall, David

    2007-01-01

    -two dogs with untreated multicentric lymphoma. Methods: Prospective observational study. Blood samples were collected at the time of diagnosis, before each chemotherapy session, and at follow-up visits, resulting in 287 serum samples. Results: Before therapy, a statistically significant majority......Background: The acute-phase protein C-reactive protein (CRP) is used as a diagnostic and prognostic marker in humans with various neoplasias, including non-Hodgkin's lymphoma. Objective: To evaluate if CRP could be used to detect different remission states in dogs with lymphoma. Animals: Twenty...... of the dogs (P = .0019) had CRP concentrations above the reference range (68%, 15/22). After achieving complete remission 90% (18/20) of the dogs had CRP concentrations within the reference range, and the difference in values before and after treatment was statistically significant (P

  15. A multicentre, randomised intervention study of the Paediatric Early Warning Score: study protocol for a randomised controlled trial

    DEFF Research Database (Denmark)

    Jensen, Claus Sixtus; Aagaard, Hanne; Olesen, Hanne Vebert

    2017-01-01

    to the Bedside PEWS in terms of reducing unplanned transfers to intensive care or transfers from regional hospitals to the university hospital among already hospitalised children. METHODS/DESIGN: This is a multicentre, randomised, controlled clinical trial where children are allocated to one of two different...... PEWS models. The study involves all paediatric departments and one emergency department in the Central Denmark Region. The primary outcome is unplanned transfer to the paediatric intensive care unit or transfer from regional hospitals to the university hospital. Based on preliminary data, 14......,000 children should be included to gain a power of 80% (with a 5% significance level) and to detect a clinically significant difference of 30% of unplanned transfers to intensive care or from regional hospitals to the paediatric department at the university department. A safety interim analysis...

  16. Self-testing for contact allergy to hair dyes - a 5-year follow-up multicentre study

    DEFF Research Database (Denmark)

    Friis, Ulrik F; Goosens, An; Giménez-Arnau, Ana Maria

    2018-01-01

    concerning the variability in instructions between products and producers, and the safety and validity of this tool. OBJECTIVES: To perform a 5-year follow-up study in order to determine whether manufacturers still recommend a self-test, and if so, whether the procedures have been changed. METHODS: During......BACKGROUND: In 2011, a multicentre study was conducted in order to determine how hair dye manufacturers instructed consumers to perform a self-test prior to dyeing their hair, in order to identify individuals who are likely to react upon subsequent hair dyeing. A number of concerns were raised...... March 2016, a total of 40 oxidative hair dye products from 21 different manufacturers were bought in retail stores in 8 European countries. RESULTS: The consumers were instructed to perform a self-test prior to hair dyeing for 39 of the products; however, the procedures varied greatly regarding...

  17. Epidemiology, pathophysiology and treatment of Kaposi sarcoma-associated herpesvirus disease: Kaposi sarcoma, primary effusion lymphoma, and multicentric Castleman disease

    Science.gov (United States)

    Sullivan, Ryan J.; Pantanowitz, Liron; Casper, Corey; Stebbing, Justin; Dezube, Bruce J.

    2009-01-01

    KSHV infection is associated with the development of three proliferative diseases: Kaposi sarcoma (KS), primary effusion lymphoma (PEL), and multicentric Castleman disease (MCD). These conditions are also intimately associated with human immunodeficiency virus (HIV) infection, and important synergistic interactions between these two viruses have been described. Despite differences in viral gene expression patterns for each condition, KSHV encodes similar oncogenic proteins which promote the activation of sequential and parallel signaling pathways. Therapeutic strategies have been implemented to target these unique signaling pathways, and such molecular targeting is the focus of many current research efforts. The scope of this review is to present contemporary knowledge about the epidemiology, virology, and immunology of KSHV, as well as highlight several key oncogene products, which may be targets for chemotherapy. PMID:18808357

  18. Prevention of fatal postoperative pulmonary embolism by low doses of heparin. An international multicentre trial.

    Science.gov (United States)

    1975-07-12

    The efficacy of low-dose heparin in preventing fatal postoperative pulmonary embolism has been investigated in a multicentre prospective randomised trial. 4121 patients over the age of forty years undergoing a variety of elective major surgical procedures were included in the trial; 2076 of these were in the control group and 2045 patients received heparin. The two groups were well matched for age, sex, weight, blood-group, and other factors which could predispose to the development of venous thromboembolism. 180 (4-4 %) patients died during the postoperative period, 100 in the control and 80 in the heparin group: 72% of deaths in the control and 66% in the heparin group had necropsy examination. 16 patients in the control group and 2 in the heparin group were found at necropsy to have died due to acute massive pulmonary embolism (P smaller than 0-005). In addition, emboli found at necropsy in 6 patients in the control group and 3 in the heparin group were considered either contributory to death or an incidental finding since death in these patients was attributed to other causes. Taking all pulmonary emboli together, the findings were again significant (P smaller than 0-005). Of 1292 patients in whom the 125-I-fibrinogen test was performed to detect deep-vein thrombosis (D.V.T.) 667 were in the control group and 625 in the heparin group. The frequency of isotopic D.V.T. was reduced from 24-6% in the control group 7-7% in the heparin group (P smaller 0-005). In 30 patients D.V.T. was detected at necropsy; 24 in the control and 6 in the heparin group (P smaller 0-005). 32 patients in the control group and 11 in the heparin group developed clinically diagnosed D.V.T. which was confirmed by venography (P smaller than 0-005). In addition, 24 patients in the control and 8 in the heparin group were treated for clinically suspected pulmonary emoblism. The difference in the number of patients requiring treatment for D.V.T. and/or pulmonary embolism in the two groups was

  19. Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy

    Science.gov (United States)

    Grangé, Gilles; Jacob, Nelly; Tanguy, Marie-Laure

    2014-01-01

    Objective To determine the efficacy of 16 hour nicotine patches among pregnant smokers, with the dose individually adjusted according to saliva cotinine levels (potential range 10-30 mg/day). Design Randomised, double blind, placebo controlled, parallel group, multicentre trial (Study of Nicotine Patch in Pregnancy, SNIPP) between October 2007 and January 2013. Setting 23 maternity wards in France. Participants 476 pregnant smokers aged more than 18 years and between 12 and 20 weeks’ gestation, who smoked at least five cigarettes a day. After exclusions, 402 women were randomised: 203 to nicotine patches and 199 to placebo patches. Data were available on 192 live births in each group. Interventions Nicotine and identical placebo patches were administered from quit day up to the time of delivery. Doses were adjusted to saliva cotinine levels when smoking to yield a substitution rate of 100%. Participants were assessed monthly and received behavioural smoking cessation support. Main outcome measures The primary outcomes were complete abstinence (self report confirmed by carbon monoxide level in expired air ≤8 ppm) from quit date to delivery, and birth weight. The secondary outcomes were point prevalence of abstinence, time to lapse (a few puffs) or relapse, and delivery and birth characteristics. All data were analysed on an intention to treat basis. Results Complete abstinence was achieved by 5.5% (n=11) of women in the nicotine patch group and 5.1% (n=10) in the placebo patch group (odds ratio 1.08, 95% confidence interval 0.45 to 2.60). The median time to the first cigarette smoked after target quit day was 15 days in both groups (interquartile range 13-18 in the nicotine patch group, 13-20 in the placebo patch group). The point prevalence abstinence ranged from 8% to 12.5% in the nicotine patch group and 8% to 9.5% in the placebo patch group without statistically significant differences. The nicotine substitution rate did not differ from 100%, and the self

  20. Comparison of ADC values in different malignancies of the skeletal musculature: a multicentric analysis

    Energy Technology Data Exchange (ETDEWEB)

    Surov, Alexey [Martin-Luther-University Halle-Wittenberg, Department of Radiology, Halle (Germany); University of Leipzig, Department of Diagnostic and Interventional Radiology, Leipzig (Germany); Nagata, Shuji [Kurume University School of Medicine, Department of Radiology, Kurume (Japan); Razek, Ahmed A. Abd [Mansoura Faculty of Medicine, Department of Diagnostic Radiology, Mansoura (Egypt); Tirumani, Sree Harsha [Harvard Medical School, Department of Imaging, Dana-Farber Cancer Institute and Department of Radiology, Brigham and Women' s Hospital, Boston, MA (United States); Wienke, Andreas [Martin-Luther-University Halle-Wittenberg, Institute of Medical Epidemiology, Biometry, and Statistics, Halle (Germany); Kahn, Thomas [University of Leipzig, Department of Diagnostic and Interventional Radiology, Leipzig (Germany)

    2015-04-28

    Diffusion-weighted imaging (DWI) provides essential information regarding tumor composition, such as cellularity and/or perfusion. DWI is helpful in distinguishing between malignant and benign lesions. Malignant intramuscular/soft tissue lesions consist of a wide spectrum of tumors that have different cell counts and matrix. It is presumed that these different tumors have different DWI findings and have different apparent diffusion coefficient (ADC) values. The aim of this study was to analyze DWI findings of different intramuscular malignancies in a multicentric study by using a standardized DWI protocol, and to compare the ADC values acquired. The data banks of four radiology departments were screened retrospectively for malignant intramuscular tumors. Only lesions that were investigated by MRI (with a 1.5-T scanner) using DWI (multishot EPI sequence with b values of 0 and 1,000 s/mm{sup 2}) were included in the study. Overall, 51 patients (28 women, 23 men; mean age 58.8 ± 16.1 years) with 57 different malignant intramuscular lesions were collected. In every case apparent diffusion constant (ADC) maps were calculated. In 14 patients muscle lymphoma, 11 patients intramuscular metastases from different primary tumors, and in 26 cases several muscle sarcomas were identified. The mean ADC value of the estimated lesions was 1.24 ± 0.53 x 10{sup -3} mm{sup 2}s{sup -1}, median value, 1.11 x 10{sup -3} mm{sup 2}s{sup -1}, range, 0.54-2.9 x 10{sup -3} mm{sup 2}s{sup -1}. The mean ADC value in muscle metastases was 1.28 ± 0.24 x 10{sup -3} mm{sup 2}s{sup -1}, in muscle lymphoma 0.76 ± 0.14 x 10{sup -3} mm{sup 2}s{sup -1}, and in muscle sarcomas 1.82 ± 0.63 x 10{sup -3} mm{sup 2}s{sup -1}. Muscle lymphoma showed statistically significant lower ADC values in comparison to muscle metastases (p = 0.01) and muscle sarcoma (p = 0.001). There was no significant differences between ADC values in muscle metastases and sarcomas (p = 0.48). ADC values in muscle lymphoma were

  1. [Motor dysfunction in stroke of subacute stage treated with acupuncture: multi-central randomized controlled study].

    Science.gov (United States)

    Chen, Li-Fang; Fang, Jian-Qiao; Wu, Yuan-Yuan; Ma, Rui-Jie; Xu, Shou-Yu; Shen, Lai-Hua; Luo, Kai-Tao; Gao, Feng; Bao, Ye-Hua; Ni, Ke-Feng; Li, Li-Ping

    2014-04-01

    To verify the clinical efficacy of acupuncture on motor dysfunction in ischemic stroke of subacute stage. The multi-central randomized controlled trial was adopted. One hundred and twenty-six cases of ischemic stroke of subacute stage were randomized into an acupuncture group (61 cases) and a conventional treatment group (65 cases). The basic treatment of western internal medicine and rehabilitation training were applied to the patients of the two groups. In the acupuncture group, acupuncture was supplemented at the body points located on the extensor of the upper limbs and the flexor of the lower limbs. In combination, scalp acupuncture was applied to NS5, MS6 and MS6 on the affected side. The treatment was given 5 times a week and totally 8 weeks were required. The follow-up observation lasted for 3 months. The scores in Fugl-Meyer scale and NIHSS scale and Barthel index were compared between the two groups before treatment, in 4 and 8 weeks of treatment and the 3-month follow-up observation after treatment separately. In 4 and 8 weeks of treatment and the follow-up observation, Fugl-Meyer scale score was improved obviously in the patients of the two groups (all PFugl-Meyer scale score in the acupuncture groupwas im proved much apparently as compared with that in the conventional treatment group [68. 0 (43. 0,86. 5) vs 52. 5 (30.3, 77.0), 77.0 (49.5, 89.0) vs 63. 0 (33.0, 84.0), both Pscale score was not reduced apparently in 4 weeks of treatment in the conventional treatment group (P>0.05), the results of NIHSS scale at the other time points were all decreased obviously as compared with those before treatment in the patients of the two groups (all P<0. 01). In 8 weeks of treatment and the follow-up observation, the results in the acupuncture group were reduced much apparently as compared with those in the conventional treatment group [5. 0 (3.0,8.0) vs 7. 0 (3.0,13.8), 4. 0 (1.5,7.0) vs 6.0 (2.0,11.7) ,both P<0. 05]. In 8 weeks of treatment and the follow

  2. Getting back to work after injury: the UK Burden of Injury multicentre longitudinal study

    Directory of Open Access Journals (Sweden)

    Kendrick Denise

    2012-08-01

    Full Text Available Abstract Background Injuries to working age adults are common and place a considerable burden on health services accounting for more than 10% of GP sick notes and 14% of those claiming benefits because they are unable to work in the UK. General practitioners (GPs currently assess fitness to work and provide care and referral to other services to facilitate return to work (RTW. Recent UK recommendations suggest replacing GP sickness certification with independent assessments of fitness to work after four weeks sick leave. The impact of a wide range of injuries on RTW and subsequent need for independent fitness to work assessments has not been well studied in the UK. The aim of this study was to quantify RTW and factors predicting RTW following a wide range of injuries. Methods We used a multicentre longitudinal study, set in four acute NHS Trusts in the UK which recruited emergency department (ED attenders and hospital admissions for injury and included those aged 16–65years that were employed or self-employed before the injury. Participants were followed up by postal questionnaire at 1, 4 and 12 months post injury to measure health status (EQ-5D, recovery, use of health and social services, time off work in the preceding month and work problems amongst those who had RTW. Multivariable Poisson regression with a robust variance estimator was used to estimate relative risks for factors associated with RTW. Results One month after injury 35% of ED attenders had fully RTW. The self employed were more likely (RR 1.70, 95% CI 1.17 to 2.47 compared with employed and the moderate/severely injured less likely to RTW (RR 0.48, 95% CI 0.32 to 0.72 compared with minor injuries. At four months, 83% of ED attenders had RTW and self employment and injury severity remained significant predictors of RTW (self employment RR 1.15, 95% CI 1.03 to 1.30; moderate/severe injury RR 0.79, 95% CI 0.68 to 0.92. At four months 57% of hospital admissions had RTW. Men were

  3. Dose escalation study to evaluate safety, tolerability and efficacy of intravenous etoposide phosphate administration in 27 dogs with multicentric lymphoma.

    Science.gov (United States)

    Boyé, Pierre; Serres, François; Marescaux, Laurent; Hordeaux, Juliette; Bouchaert, Emmanuel; Gomes, Bruno; Tierny, Dominique

    2017-01-01

    Comparative oncology has shown that naturally occurring canine cancers are of valuable and translatable interest for the understanding of human cancer biology and the characterization of new therapies. This work was part of a comparative oncology project assessing a new, clinical-stage topoisomerase II inhibitor and comparing it with etoposide in dogs with spontaneous lymphoma with the objective to translate findings from dogs to humans. Etoposide is a topoisomerase II inhibitor widely used in various humans' solid and hematopoietic cancer, but little data is available concerning its potential antitumor efficacy in dogs. Etoposide phosphate is a water-soluble prodrug of etoposide which is expected to be better tolerated in dogs. The objectives of this study were to assess the safety, the tolerability and the efficacy of intravenous etoposide phosphate in dogs with multicentric lymphoma. Seven dose levels were evaluated in a traditional 3+3 phase I design. Twenty-seven owned-dogs with high-grade multicentric lymphoma were enrolled and treated with three cycles of etoposide phosphate IV injections every 2 weeks. Adverse effects were graded according to the Veterinary Cooperative Oncology Group criteria. A complete end-staging was realized 45 days after inclusion. The maximal tolerated dose was 300 mg/m2. At this dose level, the overall response rate was 83.3% (n = 6, 3 PR and 2 CR). Only a moderate reversible gastrointestinal toxicity, no severe myelotoxicity and no hypersensitivity reaction were reported at this dose level. Beyond the characterization of etoposide clinical efficacy in dogs, this study underlined the clinical and therapeutic homologies between dog and human lymphomas.

  4. Comparison of manual and semi-automatic measuring techniques in MSCT scans of patients with lymphoma: a multicentre study

    Energy Technology Data Exchange (ETDEWEB)

    Hoeink, A.J.; Wessling, J.; Schuelke, C.; Kohlhase, N.; Wassenaar, L.; Heindel, W.; Buerke, B. [University Hospital Muenster, Department of Clinical Radiology, Muenster (Germany); Koch, R. [University of Muenster, Institute of Biostatistics and Clinical Research (IBKF), Muenster (Germany); Mesters, R.M. [University Hospital Muenster, Department of Haematology and Oncology, Muenster (Germany); D' Anastasi, M.; Graser, A.; Karpitschka, M. [University Hospital Muenchen (LMU), Institute of Clinical Radiology, Muenchen (Germany); Fabel, M.; Wulff, A. [University Hospital Kiel, Department of Clinical Radiology, Kiel (Germany); Pinto dos Santos, D. [University Hospital Mainz, Department of Diagnostic and Interventional Radiology, Mainz (Germany); Kiessling, A. [University Hospital Marburg, Department of Diagnostic and Interventional Radiology, Marburg (Germany); Dicken, V.; Bornemann, L. [Institute of Medical Imaging Computing, Fraunhofer MeVis, Bremen (Germany)

    2014-11-15

    Multicentre evaluation of the precision of semi-automatic 2D/3D measurements in comparison to manual, linear measurements of lymph nodes regarding their inter-observer variability in multi-slice CT (MSCT) of patients with lymphoma. MSCT data of 63 patients were interpreted before and after chemotherapy by one/tworadiologists in five university hospitals. In 307 lymph nodes, short (SAD)/long (LAD) axis diameter and WHO area were determined manually and semi-automatically. Volume was solely calculated semi-automatically. To determine the precision of the individual parameters, a mean was calculated for every lymph node/parameter. Deviation of the measured parameters from this mean was evaluated separately. Statistical analysis entailed intraclass correlation coefficients (ICC) and Kruskal-Wallis tests. Median relative deviations of semi-automatic parameters were smaller than deviations of manually assessed parameters, e.g. semi-automatic SAD 5.3 vs. manual 6.5 %. Median variations among different study sites were smaller if the measurement was conducted semi-automatically, e. g. manual LAD 5.7/4.2 % vs. semi-automatic 3.4/3.4 %. Semi-automatic volumetry was superior to the other parameters (2.8 %). Semi-automatic determination of different lymph node parameters is (compared to manually assessed parameters) associated with a slightly greater precision and a marginally lower inter-observer variability. These results are with regard to the increasing mobility of patients among different medical centres and in relation to the quality management of multicentre trials of importance. (orig.)

  5. Intra- and interobserver analysis in the morphological assessment of early stage embryos during an IVF procedure: a multicentre study

    Directory of Open Access Journals (Sweden)

    Devroe Johanna

    2011-09-01

    Full Text Available Abstract Background Quality control programs are necessary to maintain good clinical practice. Embryo grading has been described as one of the external quality assurance schemes. Although the evaluation of embryos is based on the assessment of morphological characteristics, considerable intra- and inter-observer variability has been described. In this multicentre study, the variability in the embryo evaluation has been evaluated using morphological characteristics on day 1, day 2 and day 3 of embryo development. Methods Five embryologists of four different IVF centers participated in this study. Multilevel images of embryos were presented on a website at different time points to evaluate intra-and inter-observer agreement in the assessment of embryo morphology. The embryos were evaluated on day 1, day 2 and day 3 of their development and each embryologist had to decide if the embryo had to be transferred, cryopreserved or discarded. Results Both intra-observer agreement and inter-observer agreement were good to excellent for the position of the pronuclei on day 1, the number of blastomeres on day 2 and day 3 and the clinical decision (transfer, cryopreservation, discard. For all other characteristics (size of pronuclei, presence of cytoplasomic halo, degree of fragmentation and size of blastomeres the intra- and inter-observer agreement was moderate to very poor. Conclusions Mono- or multicentre quality control on embryo scoring by morphological assessment can easily be performed through the design of a simple website. In the future the website design can be adapted to generate statistical feedback upon scoring and can even include a training module.

  6. [Orthogeriatrics: The First multicentre regional register of hip fractures in Castilla y León (Spain)].

    Science.gov (United States)

    Muñoz-Pascual, Angélica; Sáez-López, Pilar; Jiménez-Mola, Sonia; Sánchez-Hernández, Natalia; Alonso-García, Noelia; Andrés-Sainz, Ana Isabel; Macias-Montero, M Cruz; Vázquez-Pedrezuela, Carmen; Pereira de Castro Juez, Nieves; Del Pozo-Tagarro, Pilar; Pablos-Hernández, Carmen; Cervera-Díaz, Carmen; Cerón-Fernández, Ana; Vuelta-Calzada, Esther; Perez-Jara Carrera, Javier; González-Ramírez, Alfonso; Collado-Díaz, Teresa; Idoate-Gil, Javier; Guerrero-Díaz, M Teresa; Gutierrez-Bejarano, Dayro; Martín-Perez, Encarnación

    The objective of this study is to describe the characteristics of the patients with hip fracture admitted to the Public Hospitals of Castilla y León during three monthly periods (November 2014, and October and November 2015). The Castilla y León orthogeriatrics work group created a common register to collect data on hip fractures. The study included patients 75 years-old and over hospitalised with hip fractures in the 13 public hospitals in the community during November 2014, and October and November 2015. A multicentre, prospective, and observational study was conducted, in which clinical, functional, and social variables, as well as in-hospital mortality, were collected. The analysis included data from a total of 776 patients with a mean age of 86 (±6) years. The surgical delay was 4±2.8 days, and the mean hospital stay was 10±4.7 days. The anaesthesia risk was ASA 3±0.6. Around two-thirds (66.5%) of the patients had medical complications while in hospital, and 55.5% required a transfusion. In-hospital mortality was 4.6%. The mean pre-surgical stay was related to the overall stay: P<.001. Hip fracture registers are an essential tool for evaluating the process and for improving the treatment quality of these patients. This is the first multicentre register of hip fracture in the elderly created in a Spanish region, and could be a good precedent reference for a future national register. Copyright © 2017 SEGG. Publicado por Elsevier España, S.L.U. All rights reserved.

  7. Rationale and methodology for a multicentre randomised trial of fibrinolysis for pulmonary embolism that includes quality of life outcomes.

    Science.gov (United States)

    Kline, Jeffrey A; Hernandez, Jackeline; Hogg, Melanie M; Jones, Alan E; Courtney, D Mark; Kabrhel, Christopher; Nordenholz, Kristen E; Diercks, Deborah B; Rondina, Matthew T; Klinger, James R

    2013-12-01

    Submassive pulmonary embolism (PE) has a low mortality rate but can degrade functional capacity. The present study aims to provide rationale, methodology, and initial findings of a multicentre, randomised trial of fibrinolysis for PE that used a composite end-point, including quality of life measures. This investigator-initiated study was funded by a contract between a corporate partner and the investigator's hospital (the prime site). The investigator was the Food and Drug Administration (FDA) sponsor. The prime site subcontracted, indemnified, and trained consortia members. Consenting, normotensive patients with PE and right ventricular strain (by echocardiography or biomarkers) received low-molecular-weight heparin and random assignment to a single bolus of tenecteplase or placebo in double-blinded fashion. The outcomes were: (i) in-hospital rate of intubation, vasopressor support, and major haemorrhage, or (ii) at 90 days, death, recurrent PE, or composite that defined poor quality of life (echocardiography, 6 min walk test and surveys). The planned sample size was n = 200. Eight sites enrolled 87 patients over 5 years. The ratio of patients screened for each enrolled was 7.4 to 1, equating to 11 h screening time per patient enrolled. Primary barrier to enrolment was the cost of screening. Two patients died (2.5%, 95%CI [0-8%]), one developed shock, but 18 (22%, 95%CI: [13-30%]) had a poor quality of life. An investigator-initiated, FDA-regulated, multicentre trial of fibrinolysis for submassive PE was conducted, but was limited by screening costs and a low mortality rate. Quality of life measurements might represent a more important patient-centred end-point. © 2013 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

  8. Questing for circadian dependence in ST-segment-elevation acute myocardial infarction: A multicentric and multiethnic study

    KAUST Repository

    Ammirati, Enrico

    2013-05-09

    Rationale: Four monocentric studies reported that circadian rhythms can affect left ventricular infarct size after ST-segment-elevation acute myocardial infarction (STEMI). Objective: To further validate the circadian dependence of infarct size after STEMI in a multicentric and multiethnic population. Methods and Results: We analyzed a prospective cohort of subjects with first STEMI from the First Acute Myocardial Infarction study that enrolled 1099 patients (ischemic time <6 hours) in Italy, Scotland, and China. We confirmed a circadian variation of STEMI incidence with an increased morning incidence (from 6:00 am till noon). We investigated the presence of circadian dependence of infarct size plotting the peak creatine kinase against time onset of ischemia. In addition, we studied the patients from the 3 countries separately, including 624 Italians; all patients were treated with percutaneous coronary intervention. We adopted several levels of analysis with different inclusion criteria consistent with previous studies. In all the analyses, we did not find a clear-cut circadian dependence of infarct size after STEMI. Conclusions: Although the circadian dependence of infarct size supported by previous studies poses an intriguing hypothesis, we were unable to converge toward their conclusions in a multicentric and multiethnic setting. Parameters that vary as a function of latitude could potentially obscure the circadian variations observed in monocentric studies. We believe that, to assess whether circadian rhythms can affect the infarct size, future study design should not only include larger samples but also aim to untangle the molecular time-dynamic mechanisms underlying such a relation. © 2013 American Heart Association, Inc.

  9. Forming a national multicentre collaboration to conduct clinical trials: increasing high-quality research in the drug and alcohol field.

    Science.gov (United States)

    Sanson-Fisher, Rob; Brand, Matthew; Shakeshaft, Anthony; Haber, Paul; Day, Carolyn; Conigrave, Katherine; Mattick, Richard; Lintzeris, Nicholas; Teesson, Maree

    2010-09-01

    There is a shortage of high-quality intervention-based evidence in the drug and alcohol misuse field. That is, evidence based on replicated effects using rigorous methodology, to establish a causal knowledge base around ethical, cost-effective methods relevant to clinical practice. The knowledge base in this field is limited participant recruitment challenges; difficulty generalizing results from single-centre studies; lack of research culture; issues in managing research teams; incentives for descriptive research; and limited expertise in research design and working in multidisciplinary teams. An Australian national multicentre collaboration is proposed to overcome these barriers, and reduce the burden of drug and alcohol misuse by increasing the number of high-quality clinical trials in this field. It would involve: selecting a representative sample of centres nation-wide with expertise in specific drug and alcohol issues; creating an expert multidisciplinary team to facilitate clinical trials; simultaneous recruitment and implementation of clinical trials across centres; establishing a virtual infrastructure; forming an independent data-integrity and methodology review panel; and attracting and allocating funding for clinical trials. The ability to allocate funding, the involvement of multidisciplinary experts in drug and alcohol research, and the establishment of infrastructure and procedures are likely to result in the national multicentre group's capacity to prescribe the type of research conducted under its auspices. The proposed initiative is likely to increase the volume of high-quality clinical trials in the Australian drug and alcohol field, a key step towards reducing the burden of drug and alcohol misuse.

  10. Multiregional radiomics features from multiparametric MRI for prediction of MGMT methylation status in glioblastoma multiforme: A multicentre study.

    Science.gov (United States)

    Li, Zhi-Cheng; Bai, Hongmin; Sun, Qiuchang; Li, Qihua; Liu, Lei; Zou, Yan; Chen, Yinsheng; Liang, Chaofeng; Zheng, Hairong

    2018-03-21

    To build a reliable radiomics model from multiregional and multiparametric magnetic resonance imaging (MRI) for pretreatment prediction of O 6 -methylguanine-DNA methyltransferase (MGMT) promotor methylation status in glioblastoma multiforme (GBM). In this retrospective multicentre study, 1,705 multiregional radiomics features were automatically extracted from multiparametric MRI. A radiomics model with a minimal set of all-relevant features and a radiomics model with univariately-predictive and non-redundant features were built for MGMT methylation prediction from a primary cohort (133 patients) and tested on an independent validation cohort (60 patients). Predictive models combing clinical factors were built and evaluated. Both radiomics models were assessed on subgroups stratified by clinical factors. The radiomics model with six all-relevant features allowed pretreatment prediction of MGMT methylation (AUC=0.88, accuracy=80 %), which significantly outperformed the model with eight univariately-predictive and non-redundant features (AUC=0.76, accuracy=70 %). Combing clinical factors with radiomics features did not benefit the prediction performance. The all-relevant model achieved significantly better performance in stratified analysis. Radiomics model built from multiregional and multiparameter MRI may serve as a potential imaging biomarker for pretreatment prediction of MGMT methylation in GBM. The all-relevant features have the potential of offering better predictive power than the univariately-predictive and non-redundant features. • Multiregional and multiparametric MRI features reliably predicted MGMT methylation in multicentre cohorts. • All-relevant imaging features predicted MGMT methylation better than univariately-predictive and non-redundant features. • Combing clinical factors with radiomics features did not benefit the prediction performance.

  11. The Scandinavian Propaten(®) trial - 1-year patency of PTFE vascular prostheses with heparin-bonded luminal surfaces compared to ordinary pure PTFE vascular prostheses - a randomised clinical controlled multi-centre trial

    DEFF Research Database (Denmark)

    Lindholt, J S; Gottschalksen, B; Johannesen, N

    2011-01-01

    To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study.......To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study....

  12. Case mix classification and a benchmark set for surgery scheduling

    NARCIS (Netherlands)

    Leeftink, Gréanne; Hans, Erwin W.

    Numerous benchmark sets exist for combinatorial optimization problems. However, in healthcare scheduling, only a few benchmark sets are known, mainly focused on nurse rostering. One of the most studied topics in the healthcare scheduling literature is surgery scheduling, for which there is no widely

  13. Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Sheard, Laura; O'Hara, Jane; Armitage, Gerry; Wright, John; Cocks, Kim; McEachan, Rosemary; Watt, Ian; Lawton, Rebecca

    2014-10-29

    Estimates show that as many as one in 10 patients are harmed while receiving hospital care. Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour, with little involvement of patients. The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care. Over the past 3 years, our research team have developed, tested and refined the PRASE (Patient Reporting and Action for a Safe Environment) intervention, which gains patient feedback about quality and safety on hospital wards. A multi-centre, cluster, wait list design, randomised controlled trial with an embedded qualitative process evaluation. The aim is to assess the efficacy of the PRASE intervention, in achieving patient safety improvements over a 12-month period.The trial will take place across 32 hospital wards in three NHS Hospital Trusts in the North of England. The PRASE intervention comprises two tools: (1) a 44-item questionnaire which asks patients about safety concerns and issues; and (2) a proforma for patients to report (a) any specific patient safety incidents they have been involved in or witnessed and (b) any positive experiences. These two tools then provide data which are fed back to wards in a structured feedback report. Using this report, ward staff are asked to hold action planning meetings (APMs) in order to action plan, then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience.The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results. fieldworker diaries, ethnographic observation of APMs, structured interviews with APM lead and collection

  14. Demographic, clinical and antibody characteristics of patients with digital ulcers in systemic sclerosis: data from the DUO Registry

    NARCIS (Netherlands)

    Denton, Christopher P.; Krieg, Thomas; Guillevin, Loic; Schwierin, Barbara; Rosenberg, Daniel; Silkey, Mariabeth; Zultak, Maurice; Matucci-Cerinic, Marco; Stetter, M.; Lackner, K.; Tomi, N.; Hafner, F.; Brodmann, M.; Kuen-Spiegel, M.; Kolle, H.; Raffier, B.; Hamberger, N.; Metz, S.; Siebel, C.; Trummer, M.; Thonhofer, R.; Illmer, X.; Trautinger, F.; Schmidt, P.; Rintelen, B.; Sautner, J.; Willfort-Ehringer, A.; Margeta, C.; Monshi, B.; Pirkhammer, D.; Richter, L.; Holzer, G.; Minmair, G.; Broll, H.; Takacs, M.; Hirschl, M.; Mesaric, P.; Feldmann, R.; Semmelweis, K.; Hundstorfer, M.; Reinhart, V.; Maurer, B.; Verner, D.; Distler, O.; Schmidt-Bosshard, R.; Bohmova, J.; Prochazkova, L.; Nemec, P.; Fojtik, Z.; Soukup, T.; Smrzova, A.; Suchy, D.; Zemanova, I.; Becvar, R.; Gawlik, A.; Koch, M.; Rauen, T.; Voss, B.; Kurthen, R.; Unholzer, A.; Starz, H.; Welzel, J.; Plaumann, K.; Merk, B.; Bloching, H. H.; Moosig, F.; Frey, P.; Kahl, S.; Schleenbecker, H.; Storck-Mueller, K.; Schwarting, A.; Hazenbiller, A.; Nichelmann, V.; Flaig, W.; Rumbaur, C.; Boesenberg, I.; Schmeiser, T.; Marx, J.; Mayer, L.; Stein, T.; Ochs, W.; Rasche, C.; Worm, M.; Riemekasten, G.; Deuschle, K.; Becker, M.; Kleiner, H. J.; Schulze, K.; Tiggers, C.; Peters, J.; Kirschke, J.; Schaefer, C.; Monshausen, M.; Mengden, T.; Sadeghlar, F.; Seidel, M.; Hillebrecht, C.; Andresen, J.; Reemtsen, R.; Stoeckl, F.; Sperling, S.; Podda, M.; Wagner, N.; Guenzel, J.; Wuerzburg, I.; Luethke, K.; Enderlein, M.; Kayser, M.; Gerber, A.; Haust, M.; Hoff, N. P.; Mota, R.; Akanay-Diesel, S.; Jahnke, K.; Mettler, S.; Toeller, S.; Zwenger, S.; Klein, E.; Hahn, K.; Beyer, C.; Distler, J.; Katzemich, A.; Erfurt-berge, C.; Sticherling, M.; Schuch, F.; Rapp, P.; Mitchell, A.; Freundlieb, C.; Rushentsova, U.; Himsel, A.; Henkemeier, U.; Eilbacher, P.; Ullrich-Guenther, C.; Neul, S.; Oelsner, M.; Hermanns, G.; Fiene, M.; Gause, A.; Mensing, C.; Klings, D.; Mensing, H.; Messall, J.; Zuper, R.; May, D.; Bruckner, L.; Sheikh, N.; Aries, P.; Kirchberg, S.; Funkert, A.; Blank, N.; Lupaschko, S.; Schwuerzer-Voit, M.; Meier, L.; Herr, U.; Meier, U.; Neek, G.; Wernitzsch, H.; Pfoehler, C.; Assmann, G.; Vosswinkel, J.; Krog, B.; Wollersdorfer, E.; Oltmann-Schroeder, J.; Zeuner, R.; Uhlig, S.; Barth, S.; Huegel, R.; Glaeser, R.; Rabe, B.; Schuster, J.; Scholz, J.; Kremer, K.; Robakidze-Torbahn, M.; Moinzadeh, P.; Mittag, M.; Dohse, A.; Muhlack, A.; Schultz, L.; Schult, S.; Frambach, Y.; Kettenbach, A.; Fell, I.; Schweda, K.; Steinbrink, K.; Podobinska, M.; Harmuth, W.; Nielen, C.; Kaczmarczyk, A.; Kellner, C.; von Oelhafen, J.; von Bildering, P. B.; Kunze, S.; Niedermeier, A.; Messer, G.; Sardy, M.; Bekou, V.; Belloni, B.; Huettig, B.; Ziai, M.; Hein, R.; Hallecker, A.; Gaubitz, M.; Hallermann, C.; Schmidt, K.; Herrgott, I.; Hildebrandt, B.; Eiden, E.; Guertler, I.; Gernot Scheibl, E.; Brand, H.; Kaeding, U.; Weiss, E.; Reischel, N.; Kern, S.; Baumann, C.; Hellmich, B.; Loeffler, C.; Pflugfelder, J.; Karaenke, P.; Ruchenburg, J.; Blume, J.; Zabel, M.; Deppermann, N.; Chromik, S.; Metzler, C.; Krupp, E.; Rumpel, H.; Krause Rostock, J.-O.; Kneitz, C.; Federow, I.; Schneider, K.; Semmler, M.; Hapke, S.; Barnd, A.; Linke, M.; Kampe-Juzak, E.; Knoebel, K.; Niefanger, K.; Wilhelm, H. U.; Lauterwein, B.; Fierlbeck, G.; Schanz, S.; Pfeiffer, C.; Hassel, R.; Wahn, H.; Schildt, K.; von Elling, A.; Boro, D.; Ebel, J.; Ahmadi, K.; Moritz, D.; Dietl, S.; Dyballa, J.; Alsheimer, B.; Schuetz, N.; Schuart, T.; Mueglich, C.; Tony, H. P.; Marina, P.; Deininger, F.; Hartmann, F.; Olsen, A. B.; Sondergaard, K. H.; Naderi, Y.; Iversen, L. V.; Karlsmark, T.; Knudsen, J. B.; Gil, J. G.; Lopez, J. C. F.; Tasende, J. A. P.; Gonzales, M. F.; Sandoval, A. A.; del Carmen Torres Martin, M.; Corteguera, M.; Barca, B. A.; Montes, I. C.; de la Torre, R. G.; Victoria Egurbide, M.; Pros, A.; Munoz, J.; Simeon, C. P.; Espinosa, G.; Espinposa, G.; Rodriguez, M. A. P.; Castellvi, I.; Mascaro, J. M.; Bellido, D.; Manzanedo, V. S.; Huertas, M. P.; Sanchez, M. D. M.; Trenado, M. S. S.; Garcia, P. V.; Gines Martinez, F.; Angeles Aquirre, M.; del Rio, A. H.; Vazquez, J. L. G.; Coleman, J. V.; Lopez, M. R.; Sanchez, P. S.; Aizpuru, E. M. F.; Mateo, F. J. N.; Callejas, J. L.; Ortego, N.; Santo, M. P.; Rubio, M.; Martin, I.; Cruz, A.; Crespo, M.; Ramos, P. C.; Fernandez, A. S.-A.; Filloy, J. A. M.; Rodriguez, T. R. V.; Marhuenda, A. R.; Blanco, J. J. R.; Hernan, M. G. B.; Mendoza, A. Z.; de la Puente, C.; Rabaneda, E. V.; de Vicuna, R. G.; del Mar Ripoll Macias, M.; del la Pena Lefebvre, P. G.; de Ramon, E.; Camps, M. T.; Fernandez, C.; Miguelez, R.; Uson, J.; Delgado, E. G.; Villaverde, V.; Maceiras, F.; Cruz, J.; Mosquera, J. A.; Mera, A.; Pampin, E. P.; Blanco, J. S.; Maneiro, J. R.; Diaz, J. J.; Losada, L.; Caamano, M.; Fernandez, S.; Insua, S. A.; Laurin, C. U.; Sanchez, J.; Fernandez, N. C.; Becerra, N. D.; Garcia, A.; Nicolas, G. M.; del Carmen Ortega de la O, M.; Rueda, A.; Calvo, J.; Roman Ivorra, J.; Sancho Alegre, J. J.; Barbado, J.; Montes, J.; Saez, L.; Kaarto, A.; Makinen, H.; Madaule, S.; Dadban, A.; Lok, C.; Ferrandiz, D.; Moiton, M. P.; Magy-Bertrand, N.; Taieb, A.; Droitcourt, C.; Belin, E.; Balquiere, S.; Prey, S.; Boulon, C.; Constans, J.; Richez, C.; Sassolas, B.; Misery, L.; Greco, M.; collet, E.; Berthier, S.; Leguy-Seguin, V.; Imbert, B.; Carpentier, P.; Blaise, S.; Maillard, H.; Beneton, N.; Launay, D.; Hachulla, E.; Woijtasik, G.; Charlanne, H.; Lambert, M.; Jourdain, N.; Hatron, P. Y.; Morell, S.; Spars, A.; Couraud, A.; Doeffel-hantz, V.; Fauchais, A. L.; Vidal, E.; Goudran, G.; Bezanahary, H.; Boussely, N.; Manea, P.; Dumonteil, S.; Loustaud-ratti, V.; Hot, A.; Coppere, B.; Desmurs-Clavel, H.; Ninet, J.; Girard-Madoux, M. H.; Granel, B.; Keynote, A.; Khau van Kien, A.; Rullier, P.; Le Quellec, A.; Riviere, S.; Bessis, D.; Cohen, J. D.; Farcas, C.; Granel-brocard, F.; Agard, C.; Durant, C.; Fuzibet, J. G.; Queyrel, V.; Berezne, A.; Guillevin, L.; Mouthon, L.; Frances, C.; Toledano, C.; Cabane, J.; Tiev, K.; Farge, D.; Keshtmand, H.; Lazareth, I.; Priollet, P.; Michon-Pasturel, U.; Wipff, J.; Assous, N.; Cartry, O.; Kostrzwewa, E.; Doutre, M. S.; Blum, L.; Reguiai, Z.; Letremy, A.; Perlat, A.; Cazalets-lacoste, C.; Decaux, O.; Jego, P.; Duval-modeste, A. B.; Deboves, O.; Sordet, C.; Chatelus, E.; Chiffot, H.; Sibillia, J.; Couret, B.; Moulis, G.; Sailler, L.; Adoue, D.; Gaches, F.; Diot, E.; Skowron, F.; Zenone, T.; Quemeneur, T.; Kyndt, X.; Wahl, D.; Zuily, S.; Moline, T.; Bravetti, V.; Galanopoulos, N.; Vasilopoulos, D.; Vlachoyannopoulos, P.; Kritikos, I.; Tsifetaki, N.; Koutroumbas, A.; Garyfallos, A.; Athanassiou, P.; Aslanidis, S.; Kamali, S.; Dimitroulas, T.; Galanopoulo, V.; Elezoglou, A.; Grier, A.; Murray, M.; O'Rourke, M.; Gabrielli, A.; Lapadula, G.; Serafino, L.; Terlizzi, N.; Bellissimo, S.; Stisi, S.; Malavolta, N.; Airo, P.; Vacca, A.; Battaglia, E.; Foti, R.; Mazzuca, S.; Bortoluzzi, A.; Trotta, F.; Galluccio, F.; Marucci, A.; Cantatore, F.; Bucci, R.; Puppo, F.; de Angeli, R.; Grassi, W.; Cipriani, P.; Mazzone, A.; Faggioli, P.; Severino, A.; Scorza, R.; Belloli, L.; Ughi, N.; Antivalle, M.; del Papa, N.; Maglione, W.; Zeni, S.; Ferri, C.; Colaci, M.; Varcasia, G.; Cuomo, G.; Cozzi, F.; Triolo, G.; Gatti, S.; Montecucco, C. M.; Doveri, M.; Nigro, A.; Olivieri, I.; Bajoochi, G.; Rosato, E.; Salsano, F.; Faustini, F.; Ferraccioli, G.; Colonna, L.; Pallotta, S.; Riccieri, V.; Mussi, A.; Bellisai, F.; Galeazzi, M.; Fusaro, E.; Saracco, M.; Pellerito, R.; Masolini, P.; de Vita, S.; Lombardi, S.; Lunardi, C.; Moolenburgh, J. D.; Heurkens, A. H. M.; Voskuyl, A.; Hak, A. E.; Stroes, E. S. K.; Remans, J.; Gerdes, V.; van Woerkom, J. M.; de Long, A. J. L.; Kaasjager, H. A. H.; Visser, H.; Janssen, M.; van Guldener, C.; van Neer, F.; Vos, P.; Peters, A. J.; Hulsmans, H.; Ronday, K.; Goekoop, R.; Ewals, J.; Valentijn, R.; de Bois, M.; Westedt, M. L.; Siewertsz van Reesema, D.; Knifjj-Dutmer, E.; Stolk, J. N.; Willems, H.; Kuiper-geertsma, D. G.; Baudaoin, P.; Fretter, P.; Westra, R.; Sonnaville, P. B. J.; Smit, A.; Bootsma, H.; Brouwer, L.; Bijl, M.; Molders, N.; Lebrun, C.; van der Veen, M. J.; Noordzij, M.; Houben, H.; Landewe, R. M. B.; Vercoutere, W.; Jahangier de Veen, Z. N.; Zijlstra, T. R.; Ubels, F.; Bruyn, G.; Jansen, P.; Schuerwegh, A.; Huizinga, T. W. J.; Paassen, P.; Hurkens, T.; Geurts, M.; van den Hoogen, F.; Vonk, M.; Jacobs, P. J. C.; Groenendael, J. H. L. M.; Seys, P.; van Zeben, D.; van Paassen, H.; Groenendael, J.; Han, K. H.; Wlarvens, M.; van Hagen, M.; van Daele, P.; Dolhain, R.; Gerards, A. H.; van der Lubbe, P.; Kanter, M. D. E.; Muller, W. H.; Ton, E.; van Krugten, M.; van Gameren, I.; Lanting, P.; den Hengst, C.; Gjessdal, C. G.; Hjertaker, S. L.; Madland, T. M.; Bendvold, A.; Bitter, H.; Hoffmann-Vold, A. M.; Midtvedt, O.; Bakland, G.; Aslkaksen, H. K.; Seip, M.; Kalstad, S.; Koldingsnes, W.; Grandauent, B.; Nordvag, B. Y.; Stran, E. K.; Skomsvoll, J.; Andersen, M.; Thomsen, R. S.; Pedersen, T.; Bakkeheim, V.; Cordeiro, A.; Alves, J.; Oliveira, S.; Coelho, P.; Resende, C.; Ponte, C.; Almeida, I.; Silva, I.; Santos, C.; Camara, I.; Costa, J.; Hellstrom, H.; Mohammad, A.; Lind, I.; Lind, K.; Bracin, T.; Liljequist, E.; Vingren, T.; Ostenson, A.; Hermansson, E.; Thorsson, C.; Soderlin, M.; Nordin, A.; Waldheim, E.; Vengemyr, K.; Albertsson, K.; Karlsson, M. L.; Rydvald, Y.; Rizk, M.; Dolnicar, A. S.; Lukac, J.; James, J.; McHugh, N.; Cole, S.; Brown, S.; Hamilton, A.; Faizal, A.; Hall, F.; Murphy, K.; Skingle, S.; Harris, H.; Madhok, F.; Hampson, R.; Baguley, E.; Ogunbambi G, O.; Lamb, J.; Anderson, M.; Moots, R.; White-Alao, B.; Morrison, C.; Dobson, J.; Gordon, P.; Salerno, R.; Denton, C.; Parker, L.; Ochiel, R.; Vincent, R.; Zimba, S.; Ngcozana, T.; Xu, Y.; D'Cruz, D.; Choong, L. M.; Herrick, A.; Wragg, E.; Manning, J.; Moore, T.; Kelsey, C.; Chakravarty, K.; Skyes, H.; Athiveer, P.

    2012-01-01

    The Digital Ulcers Outcome (DUO) Registry was designed to describe the clinical and antibody characteristics, disease course and outcomes of patients with digital ulcers associated with systemic sclerosis (SSc). The DUO Registry is a European, prospective, multicentre, observational, registry of SSc

  15. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    Directory of Open Access Journals (Sweden)

    Krämer Jürgen

    2004-03-01

    Full Text Available Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial. Discussion A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers.

  16. Prevalence and correlates of non-adherence to immunosuppressants and to health behaviours in patients after kidney transplantation in Brazil - the ADHERE BRAZIL multicentre study: a cross-sectional study protocol.

    Science.gov (United States)

    Sanders-Pinheiro, Helady; Colugnati, Fernando Antonio Basile; Marsicano, Elisa Oliveira; De Geest, Sabina; Medina, José Osmar Pestana

    2018-02-20

    Non-adherence to immunosuppressive therapy is a prevalent risk factor for poor clinical and after kidney transplantation (KT), and has contributed to the lack of improvement in long-term graft survival over the past decade. Understanding the multilevel correlates and risk factors of non-adherence is crucial to determine the optimal level for planning interventions, namely at the patient, health care provider, KT centre, and health care system level. Brazil, having the largest public transplantation program in the world and with regional differences regarding access to health services and service implementation, is in a unique position to study this multilevel approach. Therefore, the Adhere Brazil Study (ADHERE BRAZIL) was designed to assess the prevalence and variability of non-adherence to immunosuppressants and to health behaviours among adult KT recipients in Brazil, and to assess the multilevel correlates of non-adherence to immunosuppressive medication. We describe the rationale, design, and methodology of the ADHERE BRAZIL study. This is an observational, cross-sectional, multicentre study that includes 20 Brazilian KT centres. A stratified sampling approach is used, based on strata, with the following characteristics considered: geographical region and transplant activity (number of KTs per year). A random sample of patients (proportional to the size of the centre within each stratum) is selected from each centre. The prevalence of different health behaviours is assessed through self-report. The assessment of multilevel correlates of non-adherence is guided by the ecological model that considers factors at the level of the patient, health-care professional, and transplant centre, using established instruments or instruments developed for this study. Data will be collected over an 18-month period, with information obtained during the regular follow-up visits to the transplant outpatient clinic and directly entered into the Research Electronic Data Capture

  17. Clinical Outcome after the Use of a New Craniocaudal Expandable Implant for Vertebral Compression Fracture Treatment: One Year Results from a Prospective Multicentric Study

    OpenAIRE

    Noriega, David; Kr?ger, Antonio; Ardura, Francisco; Hansen-Algenstaedt, Nils; Hassel, Frank; Barreau, Xavier; Beyerlein, J?rg

    2015-01-01

    The purpose of this prospective multicentric observational study was to confirm the safety and clinical performance of a craniocaudal expandable implant used in combination with high viscosity PMMA bone cement for the treatment of vertebral compression fractures. Thirty-nine VCFs in 32 patients were treated using the SpineJack minimally invasive surgery protocol. Outcome was determined by using the Visual Analogue Scale for measuring pain, the Oswestry Disability Index for scoring functional ...

  18. Work-focused cognitive-behavioural therapy and individual job support to increase work participation in common mental disorders: a randomised controlled multicentre trial

    OpenAIRE

    Reme, Silje Endresen; Grasdal, Astrid Louise; Løvvik, Camilla; Lie, Stein Atle; Øverland, Simon Nygaard

    2015-01-01

    Objectives Common mental disorders (CMDs) are a major cause of rising disability benefit expenditures. We urgently need evidence on programmes that can increase work participation in CMDs. The aim of this study was to evaluate the effectiveness of work-focused cognitive–behavioural therapy (CBT) and individual job support for people struggling with work participation due to CMDs. Methods A randomised controlled multicentre trial (RCT) including 1193 participants was conducted. Participants we...

  19. The efficacy of Femal in women with premenstrual syndrome: a randomised, double-blind, parallel-group, placebo-controlled, multicentre study

    DEFF Research Database (Denmark)

    Gerhardsen, G.; Hansen, A.V.; Killi, M.

    2008-01-01

    Introduction: A double-blind, placebo-controlled, randomised, parallel-group, multicentre study was conducted to evaluate the effect of a pollen-based herbal medicinal product, Femal (R) (Sea-Band Ltd, Leicestershire, UK), on premenstrual sleep disturbances (PSD) in women with premenstrual syndrome...... as the main symptom cluster makes this herbal medicinal product a promising addition to the therapeutic arsenal for women with PMS Udgivelsesdato: 2008/6...

  20. Managing Atypical and Typical herpetic central nervous system infections

    DEFF Research Database (Denmark)

    Cag, Yasemin; Erdem, Hakan; Leib, Stephen

    2016-01-01

    There have been many studies pertaining to the management of herpetic meningoencephalitis (HME), but the majority of them have focussed on virologically unconfirmed cases or included only small sample sizes. We have conducted a multicentre study aimed at providing management strategies for HME. O...... the subtle nature of HME, CSF HSV PCR, EEG and MRI data should be collected for all patients with a central nervous system infection....

  1. Surgery versus conservative management for recurrent and ongoing left-sided diverticulitis (DIRECT trial): an open-label, multicentre, randomised controlled trial.

    Science.gov (United States)

    van de Wall, Bryan J M; Stam, Marguerite A W; Draaisma, Werner A; Stellato, R; Bemelman, Willem A; Boermeester, Marja A; Broeders, Ivo A M J; Belgers, Eric J; Toorenvliet, Boudewijn R; Prins, Hubert A; Consten, Esther C J

    2017-01-01

    Patients with recurrent or persisting complaints after an episode of left-sided diverticulitis are managed with either conservative measures or elective sigmoidectomy. To date, there are no data from randomised trials. We aimed to establish which treatment leads to a better quality of life for patients with diverticulitis. We did an open-label, multicentre, randomised controlled trial (DIRECT trial) in 24 teaching and two academic hospitals in the Netherlands. Patients aged 18-75 years presenting with either recurrent (three or more presentations with clinical signs of acute diverticulitis within 2 years) or persistent abdominal complaints (ongoing lower left abdominal pain or persistent change in bowel habits for ≥3 months) after an episode of left-sided diverticulitis, confirmed by CT, ultrasound, or endoscopy, were included. Patients were excluded if they had previous elective or emergency surgery for acute sigmoid diverticulitis, an absolute operation indication, suspicion of a colorectal malignancy, with a preoperative or postoperative risk greater than III (on the American Society of Anesthesiologists classification), or were unable to complete questionnaire or follow-up. Patients were randomly assigned (3:3) to receive conservative management or elective (laparoscopic) sigmoidectomy using a digital randomisation system, stratified by type of disease and centre, with a block size of six. Patients, physicians, and researchers were not masked to treatment allocation. Our primary endpoint was health-related quality of life, measured by the Gastrointestinal Quality of Life Index (GIQLI) at 6 months after inclusion or surgery, depending on randomisation group. This trial is registered with trialregister.nl, number NTR1478, and is closed for inclusion. Between July 1, 2010, and April 1, 2014, we randomly assigned 109 patients to receive surgical treatment (resection; n=53) or conservative management (n=56), after which the Data Safety and Monitoring Board

  2. Comparing the prognostic accuracy for all-cause mortality of frailty instruments: a multicentre 1-year follow-up in hospitalized older patients.

    Directory of Open Access Journals (Sweden)

    Alberto Pilotto

    Full Text Available Frailty is a dynamic age-related condition of increased vulnerability characterized by declines across multiple physiologic systems and associated with an increased risk of death. We compared the predictive accuracy for one-month and one-year all-cause mortality of four frailty instruments in a large population of hospitalized older patients in a prospective multicentre cohort study.On 2033 hospitalized patients aged ≥ 65 years from twenty Italian geriatric units, we calculated the frailty indexes derived from the Study of Osteoporotic Fractures (FI-SOF, based on the cumulative deficits model (FI-CD, based on a comprehensive geriatric assessment (FI-CGA, and the Multidimensional Prognostic Index (MPI. The overall mortality rates were 8.6% after one-month and 24.9% after one-year follow-up. All frailty instruments were significantly associated with one-month and one-year all-cause mortality. The areas under the receiver operating characteristic (ROC curves estimated from age- and sex-adjusted logistic regression models, accounting for clustering due to centre effect, showed that the MPI had a significant higher discriminatory accuracy than FI-SOF, FI-CD, and FI-CGA after one month (areas under the ROC curves: FI-SOF = 0.685 vs. FI-CD = 0.738 vs. FI-CGA = 0.724 vs. MPI = 0.765, p<0.0001 and one year of follow-up (areas under the ROC curves: FI-SOF = 0.694 vs. FI-CD = 0.729 vs. FI-CGA = 0.727 vs. MPI = 0.750, p<0.0001. The MPI showed a significant higher discriminatory power for predicting one-year mortality also in hospitalized older patients without functional limitations, without cognitive impairment, malnourished, with increased comorbidity, and with a high number of drugs.All frailty instruments were significantly associated with short- and long-term all-cause mortality, but MPI demonstrated a significant higher predictive power than other frailty instruments in hospitalized older patients.

  3. The impact of patient positioning on pressure ulcers in patients with severe ARDS: results from a multicentre randomised controlled trial on prone positioning.

    Science.gov (United States)

    Girard, Raphaele; Baboi, Loredana; Ayzac, Louis; Richard, Jean-Christophe; Guérin, Claude

    2014-03-01

    Placing patients with severe acute respiratory distress syndrome (ARDS) in the prone position has been shown to improve survival as compared to the supine position. However, a higher frequency of pressure ulcers has been reported in patients in the prone position. The objective of this study was to verify the impact of prone positioning on pressure ulcers in patients with severe ARDS. This was an ancillary study of a prospective multicentre randomised controlled trial in patients with severe ARDS in which the early application of long prone-positioning sessions was compared to supine positioning in terms of mortality. Pressure ulcers were assessed at the time of randomisation, 7 days later and on discharge from the intensive care unit (ICU), using the four-stage Pressure Ulcers Advisory Panel system. The primary end-point was the incidence (with reference to 1,000 days of invasive mechanical ventilation or 1,000 days of ICU stay) of new patients with pressure ulcers at stage 2 or higher from randomisation to ICU discharge. At randomisation, of the 229 patients allocated to the supine position and the 237 patients allocated to the prone position, the number of patients with pressure ulcers was not significantly different between groups. The incidence of new patients with pressure ulcers from randomisation to ICU discharge was 20.80 and 14.26/1,000 days of invasive mechanical ventilation (P = 0.061) and 13.92 and 7.72/1,000 of ICU days (P = 0.002) in the prone and supine groups, respectively. Position group [odds ratio (OR) 1.5408, P = 0.0653], age >60 years (OR 1.5340, P = 0.0019), female gender (OR 0.5075, P = 0.019), body mass index of >28.4 kg/m(2) (OR 1.9804, P = 0.0037), and a Simplified Acute Physiology Score II at inclusion of >46 (OR 1.2765, P = 0.3158) were the covariates independently associated to the acquisition of pressure ulcers. In patients with severe ARDS, prone positioning was associated with a higher frequency of pressure ulcers than the supine

  4. Estimating glomerular filtration rate by serum creatinine or/and cystatin C equations: An analysis of multi-centre Chinese subjects.

    Science.gov (United States)

    Ye, Xiaoshuang; Liu, Xun; Song, Dan; Zhang, Xiaoxuan; Zhu, Bei; Wei, Lu; Pei, Xiaohua; Wu, Jianqing; Lou, Tanqi; Zhao, Weihong

    2016-05-01

    Various equations based on serum creatinine or/and cystatin C, required further validation in a Chinese population. We compared the performance of six Chinese equations (Mascr, Peiscr, Macys, Fengcys, Mascr-cys and Fengscr-cys) with the CKD-EPI equations in multi-centre Chinese subjects and evaluated their applicability in clinical practice. A total of 1522 adult patients from four different hospitals of China were enrolled in the study. (99m) Tc-DTPA renal dynamic imaging was used as the reference GFR (rGFR), and serum creatinine and cystatin C were measured by standardized assays. An optimal score system was implemented in the study. The average rGFR of recruited subjects was 67.30±28.89 mL/min per 1.73m(2) . All estimated GFR (eGFR) correlated well with rGFR. In accordance with Bland-Altman analysis, the Fengscr-cys equations achieved optimal overall performance (score 14 vs 0-6), with least bias (median difference, -0.57 mL/min per 1.73m(2) ; median absolute difference, 8.83 mL/min per 1.73m(2) ), best precision (17.99 mL/min per 1.73m(2) ), highest accuracy (percentage of eGFR within 15%, 30% and 50% of the rGFR (P15 , P30 and P50 ; 49.7%, 78.7% and 91.8%, respectively); root-mean-square-error (RMSE, 16.28)). The Fengcys equation, a typical cystatin C based equation, was another well-behaved formula with an impressive performance. The Ma equations performed much poorer than the CKD-EPI equations. Consistent results can be observed in the GFR- /age- and sex-specific subgroups, while none equation yielded ideal accuracy in GFR<60 mL/min per 1.73 m(2) subgroup. The Fengscr-cys equation appeared to achieve the best performance for GFR estimation in overall Chinese adult patients. However, further research is warranted to improve the accuracy of available equations in GFR less than 60 mL/min per 1.73 m(2) individuals. © 2015 Asian Pacific Society of Nephrology.

  5. Sarcoma granulocítico multicêntrico como recidiva de leucemia mieloide aguda Multicentric granulocytic sarcoma as relapse of acute myelogenous leukemia

    Directory of Open Access Journals (Sweden)

    Taciana G. S. Aguiar

    2009-01-01

    Full Text Available Sarcoma granulocítico (SG é um tumor sólido extramedular, constituído por células precursoras de granulócitos. É geralmente associado a leucemia mieloide aguda ou raramente a outras desordens mieloproliferativas. O tumor geralmente ocorre precedendo uma leucemia mieloide aguda, durante o seu curso ou após a remissão ter sido alcançada. O prognóstico é pobre e tem como principais modalidades terapêuticas a quimioterapia e a radioterapia. Relata- se um caso de SG multicêntrico, de evolução rápida, com acometimento difuso de pele, mamas, gânglios linfáticos, tecido celular subcutâneo e líquor, em mulher de 45 anos, fora de tratamento para leucemia mieloide aguda e em remissão hematológica há 18 meses. A paciente apresentava dor intensa em membro inferior direito há uma semana e estava em anticoagulação oral há seis meses por trombose venosa profunda neste membro. Diagnosticado o SG, a paciente foi tratada com radioterapia e quimioterapia com boa resposta. Após três meses de seguimento, em vigência do tratamento quimioterápico, evoluiu com recidiva do SG neste membro, associado ao acometimento das mamas e posteriormente do sistema nervoso central, evoluindo para óbito em aplasia e sepses.Granulocytic sarcoma is an extramedullary solid tumor consisting of immature granulocytic cells. It is often associated with acute myelogenous leukemia and more rarely with other myeloproliferative disorders. The tumor generally occurs before acute myeloid leukemia, during its course or after disease remission. It has a poor prognosis with the main therapeutic options being chemotherapy and radiotherapy. A multicentric accelerated case of granulocytic sarcoma of a 45- year- old woman with diffuse skin, breast, lymphatic ganglia and subcutaneous tissue presentations no longer undergoing treatment for acute myeloid leukemia and in hematologic remission for 18 months is reported. The patient presented with severe pain of right lower

  6. Predictive value of {sup 18}F-FDG PET/CT in restaging patients affected by ovarian carcinoma: a multicentre study

    Energy Technology Data Exchange (ETDEWEB)

    Caobelli, Federico [Medizinische Hochschule Hannover, Klinik fuer Nuklearmedizin, Hanover (Germany); Alongi, Pierpaolo [University of Milano-Bicocca, Nuclear Medicine Unit, Milan (Italy); IRCSS San Raffaele Scientific Institute, Nuclear Medicine Department, Milan (Italy); Evangelista, Laura; Saladini, Giorgio [Veneto Institute of Oncology IOV - IRCCS, Radiotherapy and Nuclear Medicine Unit, Padua (Italy); Picchio, Maria [IRCSS San Raffaele Scientific Institute, Nuclear Medicine Department, Milan (Italy); Rensi, Marco; Geatti, Onelio [Hospital of Udine, Nuclear Medicine Department, Udine (Italy); Castello, Angelo; Laghai, Iashar [University of Florence, Nuclear Medicine Department, Florence (Italy); Popescu, Cristina E. [Niguarda Ca' Granda Hospital, Nuclear Medicine Department, Milan (Italy); Dolci, Carlotta; Crivellaro, Cinzia [University of Milan-Bicocca, Nuclear Medicine Department, San Gerardo Hospital, Tecnomed Foundation, Milan (Italy); Seghezzi, Silvia [Hospital of Treviglio, Nuclear Medicine Department, Treviglio, Bergamo (Italy); Kirienko, Margarita [University of Milano-Bicocca, Nuclear Medicine Unit, Milan (Italy); De Biasi, Vincenzo [Nuclear Medicine Department, Arcispedale Santa Maria Nuova, Reggio Emilia (Italy); Cocciolillo, Fabrizio [Catholic University of the Sacred Heart, Nuclear Medicine Department, Rome (Italy); Quartuccio, Natale [University of Messina, Nuclear Medicine Unit, Department of Biomedical Sciences and of Morphological and Functional Images, Messina (Italy); Collaboration: Young AIMN Working Group

    2016-03-15

    Ovarian cancer is the eighth most common malignancy among women and has a high mortality rate. Prognostic factors able to drive an effective therapy are essential. {sup 18}F-Fluoro-2-deoxyglucose positron emission tomography/computed tomography ({sup 18}F-FDG PET/CT) has been investigated in patients with epithelial ovarian cancer and showed promise in diagnosing, staging, detecting recurrent lesions and monitoring treatment response. Conversely, its prognostic role remains unclear. We aimed at assessing the prognostic value of {sup 18}F-FDG PET/CT performed in the restaging process in a multicentre study. We evaluated 168 patients affected by ovarian carcinoma, who underwent a restaging {sup 18}F-FDG PET/CT. The presence of local recurrences, lymph node involvement and distant metastasis was recorded as well as lesion dimensions, maximum and mean standardized uptake values (SUV{sub max} and SUV{sub mean}, respectively). Progression-free survival (PFS) and overall survival (OS) at 3 and 4 years were computed by using Kaplan-Meier curves. Increased odds ratio was assessed using Cox regression analysis testing all lesion parameters measured by PET/CT. PFS was significantly longer in patients with a negative than a positive restaging PET/CT study (3- and 4-year PFS 64 and 53 % vs 23 and 12 %, respectively; p < 0.001). Similarly, a negative study was associated with a significantly higher OS rate after 4 years of follow-up (67 vs 25 % in negative and positive groups, respectively; p < 0.001). Lymph node or distant involvement were also independently associated with an increased risk of disease progression [hazard ratio (HR) 1.6 and 2.2, respectively; p = 0.003]. Moreover, PET/CT showed an incremental prognostic value compared to the International Federation of Gynecology and Obstetrics (FIGO) staging system. In the analysis of patient subsets, individuals with the same FIGO stage I-II but with negative PET had a significantly better 4-year OS than patients with low

  7. Cohort profile: the Italian Network of Longitudinal Metropolitan Studies (IN-LiMeS), a multicentre cohort for socioeconomic inequalities in health monitoring.

    Science.gov (United States)

    Caranci, Nicola; Di Girolamo, Chiara; Giorgi Rossi, Paolo; Spadea, Teresa; Pacelli, Barbara; Broccoli, Serena; Ballotari, Paola; Costa, Giuseppe; Zengarini, Nicolás; Agabiti, Nera; Bargagli, Anna Maria; Cacciani, Laura; Canova, Cristina; Cestari, Laura; Biggeri, Annibale; Grisotto, Laura; Terni, Gianna; Costanzo, Gianfranco; Mirisola, Concetta; Petrelli, Alessio

    2018-04-20

    The Italian Network of Longitudinal Metropolitan Studies (IN-LiMeS) is a system of integrated data on health outcomes, demographic and socioeconomic information, and represents a powerful tool to study health inequalities. IN-LiMeS is a multicentre and multipurpose pool of metropolitan population cohorts enrolled in nine Italian cities: Turin, Venice, Reggio Emilia, Modena, Bologna, Florence, Leghorn, Prato and Rome. Data come from record linkage of municipal population registries, the 2001 population census, mortality registers and hospital discharge archives. Depending on the source of enrolment, cohorts can be closed or open. The census-based closed cohort design includes subjects resident in any of the nine cities at the 2001 census day; 4 466 655 individuals were enrolled in 2001 in the nine closed cohorts. The open cohort design includes subjects resident in 2001 or subsequently registered by birth or immigration until the latest available follow-up (currently 31 December 2013). The open cohort design is available for Turin, Venice, Reggio Emilia, Modena, Bologna, Prato and Rome. Detailed socioeconomic data are available for subjects enrolled in the census-based cohorts; information on demographic characteristics, education and citizenship is available from population registries. The first IN-LiMeS application was the study of differentials in mortality between immigrants and Italians. Either using a closed cohort design (nine cities) or an open one (Turin and Reggio Emilia), individuals from high migration pressure countries generally showed a lower mortality risk. However, a certain heterogeneity between the nine cities was noted, especially among men, and an excess mortality risk was reported for some macroareas of origin and specific causes of death. We are currently working on the linkage of the 2011 population census data, the expansion of geographical coverage and the implementation of the open design in all the participating cohorts. © Article author

  8. Multicentre evaluation of magnetic resonance imaging supported transperineal prostate biopsy in biopsy-naïve men with suspicion of prostate cancer.

    Science.gov (United States)

    Hansen, Nienke L; Barrett, Tristan; Kesch, Claudia; Pepdjonovic, Lana; Bonekamp, David; O'Sullivan, Richard; Distler, Florian; Warren, Anne; Samel, Christina; Hadaschik, Boris; Grummet, Jeremy; Kastner, Christof

    2017-10-11

    To analyse the detection rates of primary magnetic resonance imaging (MRI)-fusion transperineal prostate biopsy using combined targeted and systematic core distribution in three tertiary referral centres. In this multicentre, prospective outcome study, 807 consecutive biopsy-naïve patients underwent MRI-guided transperineal prostate biopsy, as the first diagnostic intervention, between 10/2012 and 05/2016. MRI was reported following the Prostate Imaging-Reporting and Data System (PI-RADS) criteria. In all, 236 patients had 18-24 systematic transperineal biopsies only, and 571 patients underwent additional targeted biopsies either by MRI-fusion or cognitive targeting if PI-RADS ≥3 lesions were present. Detection rates for any and Gleason score 7-10 cancer in targeted and overall biopsy were calculated and predictive values were calculated for different PI-RADS and PSA density (PSAD) groups. Cancer was detected in 68% of the patients (546/807) and Gleason score 7-10 cancer in 49% (392/807). The negative predictive value of 236 PI-RADS 1-2 MRI in combination with PSAD of PI-RADS 4-5 lesions using targeted plus systematic biopsies, the cancer detection rate of Gleason score 7-10 was significantly higher at 71% vs 59% and 61% with either approach alone (P PI-RADS 3 lesions, the detection rate was 31% with no significant difference to systematic biopsies with 27% (P > 0.05). Limitations include variability of multiparametric MRI (mpMRI) reading and Gleason grading. MRI-based transperineal biopsy performed at high-volume tertiary care centres with a significant experience of prostate mpMRI and image-guided targeted biopsies yielded high detection rates of Gleason score 7-10 cancer. Prostate biopsies may not be needed for men with low PSAD and an unsuspicious MRI. In patients with high probability lesions, combined targeted and systematic biopsies are recommended. © 2017 The Authors BJU International © 2017 BJU International Published by John Wiley & Sons Ltd.

  9. A multilayer biomaterial for osteochondral regeneration shows superiority vs microfractures for the treatment of osteochondral lesions in a multicentre randomized trial at 2 years.

    Science.gov (United States)

    Kon, Elizaveta; Filardo, Giuseppe; Brittberg, Mats; Busacca, Maurizio; Condello, Vincenzo; Engebretsen, Lars; Marlovits, Stefan; Niemeyer, Philipp; Platzer, Patrik; Posthumus, Michael; Verdonk, Peter; Verdonk, Renè; Victor, Jan; van der Merwe, Willem; Widuchowski, Wojciech; Zorzi, Claudio; Marcacci, Maurilio

    2017-09-14

    The increasing awareness on the role of subchondral bone in the etiopathology of articular surface lesions led to the development of osteochondral scaffolds. While safety and promising results have been suggested, there are no trials proving the real potential of the osteochondral regenerative approach. Aim was to assess the benefit provided by a nanostructured collagen-hydroxyapatite (coll-HA) multilayer scaffold for the treatment of chondral and osteochondral knee lesions. In this multicentre randomized controlled clinical trial, 100 patients affected by symptomatic chondral and osteochondral lesions were treated and evaluated for up to 2 years (51 study group and 49 control group). A biomimetic coll-HA scaffold was studied, and bone marrow stimulation (BMS) was used as reference intervention. Primary efficacy measurement was IKDC subjective score at 2 years. Secondary efficacy measurements were: KOOS, IKDC Knee Examination Form, Tegner and VAS Pain scores evaluated at 6, 12 and 24 months. Tissue regeneration was evaluated with MRI MOCART scoring system at 6, 12 and 24 months. An external independent agency was involved to ensure data correctness and objectiveness. A statistically significant improvement of all clinical scores was obtained from basal evaluation to 2-year follow-up in both groups, although no overall statistically significant differences were detected between the two treatments. Conversely, the subgroup of patients affected by deep osteochondral lesions (i.e. Outerbridge grade IV and OCD) showed a statistically significant better IKDC subjective outcome (+12.4 points, p = 0.036) in the coll-HA group. Statistically significant better results were also found for another challenging group: sport active patients (+16.0, p = 0.027). Severe adverse events related to treatment were documented only in three patients in the coll-HA group and in one in the BMS group. The MOCART score showed no statistical difference between the two groups. This

  10. KidsBrainIT: A New Multi-centre, Multi-disciplinary, Multi-national Paediatric Brain Monitoring Collaboration.

    Science.gov (United States)

    Lo, T; Piper, I; Depreitere, B; Meyfroidt, G; Poca, M; Sahuquillo, J; Durduran, T; Enblad, P; Nilsson, P; Ragauskas, A; Kiening, K; Morris, K; Agbeko, R; Levin, R; Weitz, J; Park, C; Davis, P

    2018-01-01

    Validated optimal cerebral perfusion pressure (CPP) treatment thresholds in children do not exist. To improve the intensive care unit (ICU) management of the paediatric traumatic brain injury (TBI) population, we are forming a new paediatric multi-centre collaboration to recruit standardised ICU data for running and reporting upon models for assessing autoregulation and optimal CCP (CPPopt). We are adapting the adult BrainIT group's approach to develop a new Paediatric Brain Monitoring and Information Technology Group (KidsBrainIT), which will include a repository to store prospectively collected high-resolution physiological, clinical, and outcome data. In the first phase of this project there are 7 UK Paediatric Intensive Care Units, 1 Spanish, 1 Belgium, and 1 Romanian Centre interested in participating. In subsequent phases, we plan to open recruitment to other centres both within Europe, US and abroad. We are collaborating with the Leuven Group and plan to use their LAx (low-frequency autoregulation index), DATACAR (dynamic adaptive target of active cerebral autoregulation), CPPopt and visualisation methodologies. We also plan to use the continuous diffuse optical monitoring and tomography technology developed in Barcelona as an acute surrogate end-point for optimising brain perfusion. This technology allows non-invasive continuous monitoring of deep tissue perfusion and oxygenation in adults but its clinical application in infants and children with TBI has not been studied previously. We report on the current status of setting up this new collaboration and also on pilot analyses in two centres which are the basis of our rationale for the need for a prospective validation study of CPPopt in children. Specifically, we demonstrated that CPPopt varied with time for each patient during their paediatric intensive care unit (PICU) stay, and the median overall CPPopt levels for children aged 2-6 years, 7-11 years and 12-16 years were 68.83, 68.09, and 72.17 mm

  11. Calibration of gamma camera systems for a multicentre European ¹²³I-FP-CIT SPECT normal database

    DEFF Research Database (Denmark)

    Tossici-Bolt, Livia; Dickson, John C; Sera, Terez

    2011-01-01

    A joint initiative of the European Association of Nuclear Medicine (EANM) Neuroimaging Committee and EANM Research Ltd. aimed to generate a European database of [(123)I]FP-CIT single photon emission computed tomography (SPECT) scans of healthy controls. This study describes the characterization a...

  12. Medicare program; prospective payment system and consolidated billing for skilled nursing facilities for FY 2010; minimum data set, version 3.0 for skilled nursing facilities and Medicaid nursing facilities. Final rule.

    Science.gov (United States)

    2009-08-11

    This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year (FY) 2010. In addition, it recalibrates the case-mix indexes so that they more accurately reflect parity in expenditures related to the implementation of case-mix refinements in January 2006. It also discusses the results of our ongoing analysis of nursing home staff time measurement data collected in the Staff Time and Resource Intensity Verification project, as well as a new Resource Utilization Groups, version 4 case-mix classification model for FY 2011 that will use the updated Minimum Data Set 3.0 resident assessment for case-mix classification. In addition, this final rule discusses the public comments that we have received on these and other issues, including a possible requirement for the quarterly reporting of nursing home staffing data, as well as on applying the quality monitoring mechanism in place for all other SNF PPS facilities to rural swing-bed hospitals. Finally, this final rule revises the regulations to incorporate certain technical corrections.

  13. Comparative assessment of image quality for coronary CT angiography with iobitridol and two contrast agents with higher iodine concentrations: iopromide and iomeprol. A multicentre randomized double-blind trial

    Energy Technology Data Exchange (ETDEWEB)

    Achenbach, Stephan [Friedrich-Alexander-Universitaet Erlangen-Nuernberg, Department of Cardiology, Erlangen (Germany); Paul, Jean-Francois [Centre Chirurgical Marie Lannelongue, Department of Radiology, Le Plessis Robinson (France); Laurent, Francois [University of Bordeaux, Centre de Recherche Cardio-Thoracique de Bordeaux, U1045, Bordeaux (France); CHU de Bordeaux, Service d' Imagerie Thoracique et Cardiovasculaire, Pessac (France); Becker, Hans-Christoph [University Hospital Grosshadern, Department of Clinical Radiology, Munich (Germany); Rengo, Marco [Sapienza - University of Rome, ICOT Hospital, Department of Radiological Sciences, Oncology and Pathology, Latina (Italy); Caudron, Jerome [University Hospital of Rouen, Department of Radiology, Rouen (France); Leschka, Sebastian [Saint Gallen Hospital, Department of Radiology, Saint Gallen (Switzerland); Vignaux, Olivier [Cochin Hospital, Department of Radiology, Paris (France); Knobloch, Gesine [La Charite, Department of Radiology, Berlin (Germany); Benea, Giorgio [Ospedale del Delta, Ferrara (Italy); Schlosser, Thomas [Elisabeth-Krankenhaus Hospital, Essen (Germany); Andreu, Jordi [Hospital Vall d' Hebron, Barcelona (Spain); Cabeza, Beatriz [Hospital Clinico San Carlos, Madrid (Spain); Jacquier, Alexis [La Timone Adult Hospital, Department of Radiology, Marseille (France); Souto, Miguel [Complejo Hospitalario Universitario, Santiago de Compostela (Spain); Revel, Didier [Louis Pradel Hospital, Department of Radiology, Lyon (France); Qanadli, Salah Dine [University of Lausanne, Department of Radiology, Lausanne (Switzerland); Cademartiri, Filippo [Giovanni XXIII Hospital, Department of Radiology, Monastier di Treviso (Italy); Collaboration: X-ACT Study Group

    2017-02-15

    To demonstrate non-inferiority of iobitridol 350 for coronary CT angiography (CTA) compared to higher iodine content contrast media regarding rate of patients evaluable for the presence of coronary artery stenoses. In this multicentre trial, 452 patients were randomized to receive iobitridol 350, iopromide 370 or iomeprol 400 and underwent coronary CTA using CT systems with 64-detector rows or more. Two core lab readers assessed 18 coronary segments per patient regarding image quality (score 0 = non diagnostic to 4 = excellent quality), vascular attenuation, signal and contrast to noise ratio (SNR, CNR). Patients were considered evaluable if no segment had a score of 0. Per-patient, the rate of fully evaluable CT scans was 92.1, 95.4 and 94.6 % for iobitridol, iopromide and iomeprol, respectively. Non-inferiority of iobitridol over the best comparator was demonstrated with a 95 % CI of the difference of [-8.8 to 2.1], with a pre-specified non-inferiority margin of -10 %. Although average attenuation increased with higher iodine concentrations, average SNR and CNR did not differ between groups. With current CT technology, iobitridol 350 mg iodine/ml is not inferior to contrast media with higher iodine concentrations in terms of image quality for coronary stenosis assessment. (orig.)

  14. Medicare program; prospective payment system and consolidated billing for skilled nursing facilities for FY 2012. Final rule.

    Science.gov (United States)

    2011-08-08

    This final rule updates the payment rates used under the prospective payment system for skilled nursing facilities (SNFs) for fiscal year 2012. In addition, it recalibrates the case-mix indexes so that they more accurately reflect parity in expenditures between RUG-IV and the previous case-mix classification system. It also includes a discussion of a Non-Therapy Ancillary component currently under development within CMS. In addition, this final rule discusses the impact of certain provisions of the Affordable Care Act, and reduces the SNF market basket percentage by the multi-factor productivity adjustment. This rule also implements certain changes relating to the payment of group therapy services and implements new resident assessment policies. Finally, this rule announces that the proposed provisions regarding the ownership disclosure requirements set forth in section 6101 of the Affordable Care Act will be finalized at a later date.

  15. Colorectal cancer and its association with the metabolic syndrome: a Malaysian multi-centric case-control study.

    Science.gov (United States)

    Ulaganathan, V; Kandiah, M; Zalilah, M S; Faizal, J A; Fijeraid, H; Normayah, K; Gooi, B H; Othman, R

    2012-01-01

    Colorectal cancer (CRC) and the metabolic syndrome (MetS) are both on the rise in Malaysia. A multi-centric case-control study was conducted from December 2009 to January 2011 to determine any relationship between the two. Patients with confirmed CRC based on colonoscopy findings and cancer free controls from five local hospitals were assessed for MetS according to the International Diabetes Federation (IDF) definition. Each index case was matched for age, gender and ethnicity with two controls (140: 280). MetS among cases was highly prevalent (70.7%), especially among women (68.7%). MetS as an entity increased CRC risk by almost three fold independently (OR=2.61, 95%CI=1.53-4.47). In men MetS increased the risk of CRC by two fold (OR=2.01, 95%CI, 1.43-4.56), demonstrating an increasing trend in risk with the number of Mets components observed. This study provides evidence for a positive association between the metabolic syndrome and colorectal cancer. A prospective study on the Malaysian population is a high priority to confirm these findings.

  16. Recruiting ENT and Audiology patients into pharmaceutical trials: evaluating the multi-centre experience in the UK and USA.

    Science.gov (United States)

    Sanchez, Victoria A; Hall, Deborah A; Millar, Bonnie; Escabi, Celia D; Sharman, Alice; Watson, Jeannette; Thasma, Sornaraja; Harris, Peter

    2018-01-21

    Recruiting into clinical trials on time and on target is a major challenge and yet often goes unreported. This study evaluated the adjustment to procedures, recruitment and screening methods in two multi-centre pharmaceutical randomised controlled trials (RCTs) for hearing-related problems in adults. Recruitment monitoring and subsequent adjustment of various study procedures (e.g. eligibility criteria, increasing recruiting sites and recruitment methods) are reported. Participants were recruited through eight overarching methods: trial registration, posters/flyers, print publications, Internet, social media, radio, databases and referrals. The efficiency of the recruitment was measured by determining the number of people: (1) eligible for screening as a percentage of those who underwent telephone pre-screening and (2) randomised as a percentage of those screened. A total of 584 participants completed the pre-screening steps, 491 screened and 169 participants were randomised. Both RCTs completed adjustments to the participant eligibility, added new study sites and additional recruitment methods. No single recruitment method was efficient enough to serve as the only route to enrolment. A diverse portfolio of methods, continuous monitoring, mitigation strategy and adequate resourcing were essential for achieving our recruitment goals.

  17. Sorafenib in metastatic uveal melanoma: efficacy, toxicity and health-related quality of life in a multicentre phase II study

    Science.gov (United States)

    Mouriaux, F; Servois, V; Parienti, J J; Lesimple, T; Thyss, A; Dutriaux, C; Neidhart-Berard, E M; Penel, N; Delcambre, C; Peyro Saint Paul, L; Pham, A D; Heutte, N; Piperno-Neumann, S; Joly, F

    2016-01-01

    Background: The aim of the study was to analyse efficacy, safety, and health-related quality of life (HRQoL) for sorafenib treatment in patients with metastatic uveal melanoma. Methods: A multicentre, single-arm phase II trial was conducted. The primary objective was to determine the non-progression rate (RECIST) at 24 weeks for patients receiving sorafenib at a dose of 800 mg per day. Secondary endpoints included progression-free survival (PFS), overall survival (OS), toxicity, and HRQoL. Results: Thirty-two patients were included. Ten patients showed non-progression at 24 weeks (31.2%) without objective tumour responses. The estimated 24-week PFS was 31.2% (95% CI: 14.8%–47.6%) and the estimated 24-week OS was 62.5% (95% CI: 45.4%–79.6%). Ten patients (34.3%) had at least one grade 3 or 4 adverse reaction and 12 patients (41.4%) required dose modifications due to toxicity. At 24 weeks, no patient had an improvement in global HRQoL and 87.5% experienced a permanent increase in physical fatigue. Conclusions: Sorafenib demonstrated non-progression at 24 weeks in 31.2% of patients. However, 41.4% of patients required dose modifications due to toxicity and no improvement in HRQoL was demonstrated. PMID:27253171

  18. Influenza A/H1N1 MF59 adjuvanted vaccine in pregnant women and adverse perinatal outcomes: multicentre study

    Science.gov (United States)

    Micone, P; Bonotti, A; Wainer, V; Schwarcz, A; Augustovski, F; Pichon Riviere, A; Karolinski, A

    2013-01-01

    Objective To assess the risk of adverse perinatal events of vaccination of pregnant women with an MF59 adjuvanted vaccine. Design Cross sectional multicentre study. Setting 49 public hospitals in major cities in Argentina, from September 2010 to May 2011. Participants 30 448 mothers (7293 vaccinated) and their 30 769 newborns. Main outcome measure Primary composite outcome of low birth weight, preterm delivery, or fetal or early neonatal death up to seven days postpartum. Results Vaccinated women had a lower risk of the primary composite outcome (7.0% (n=513) v 9.3% (n=2160); adjusted odds ratio 0.80, 95% confidence interval 0.72 to 0.89). The propensity score analysis showed similar results. Adjusted odds ratios for vaccinated women were 0.74 (0.65 to 0.83) for low birth weight, 0.79 (0.69 to 0.90) for preterm delivery, and 0.68 (0.42 to 1.06) for perinatal mortality. These findings were consistent in further subgroup analysis. No significant differences in maternal outcomes were found. Conclusion This large study using primary data collection found that MF59 adjuvanted A/H1N1 influenza vaccine did not result in an increased risk of adverse perinatal events and suggested a lower risk among vaccinated women. These findings should contribute to inform stakeholders and decision makers on the prescription of vaccination against influenza A/H1N1 in pregnant women. PMID:23381200

  19. Psychological and psychosocial functioning of children with burn scarring using cosmetic camouflage: a multi-centre prospective randomised controlled trial.

    Science.gov (United States)

    Maskell, Jessica; Newcombe, Peter; Martin, Graham; Kimble, Roy

    2014-02-01

    Burns leave patients with long-term physical scarring. Children with scarring are required to face challenges of reintegration into their community, including acceptance of an altered appearance and acceptance by others. This can be difficult given society's preoccupation with physical appearance. Limited research exists investigating validity of cosmetic camouflage as a psychosocial intervention for children with scarring. This study investigated whether using cosmetic camouflage (Microskin™) had a positive impact on health-related quality of life, self-concept and psychopathology for children and adolescents (8-17 years) with burn scarring. A prospective multi-centre randomised controlled trial was conducted across Australian and New Zealand paediatric hospitals. 63 participants (49 females, mean age 12.7 ± 2.1 years) were enrolled. Data points were baseline (Time 1) and at 8 weeks (Time 2) using reliable and valid psychometric measures. Findings indicate there were significant improvements in socialisation, school and appearance scales on the Paediatric Quality of Life Inventory and psychopathology scores particularly peer problems decreased. However self-concept remained stable from baseline throughout intervention use. Cosmetic camouflage appears to have a positive impact on quality of life particularly socialisation. Cosmetic camouflage is a valid tool to assist children with scarring to actively participate socially within their communities. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

  20. Does Cataract Surgery Alleviate Poverty? Evidence from a Multi-Centre Intervention Study Conducted in Kenya, the Philippines and Bangladesh

    Science.gov (United States)

    Kuper, Hannah; Polack, Sarah; Mathenge, Wanjiku; Eusebio, Cristina; Wadud, Zakia; Rashid, Mamunur; Foster, Allen

    2010-01-01

    Background Poverty and blindness are believed to be intimately linked, but empirical data supporting this purported relationship are sparse. The objective of this study is to assess whether there is a reduction in poverty after cataract surgery among visually impaired cases. Methodology/Principal Findings A multi-centre intervention study was conducted in three countries (Kenya, Philippines, Bangladesh). Poverty data (household per capita expenditure – PCE, asset ownership and self-rated wealth) were collected from cases aged ≥50 years who were visually impaired due to cataract (visual acuityassets and self-rated wealth. By follow-up PCE had increased significantly among operated cases in each of the three settings to the level of controls (Kenya: $30 versus £36 p = 0.49, Bangladesh: $23 vs $23 p = 0.20, Philippines: $45 vs $36 p = 0.68). There were smaller increases in self-rated wealth and no changes in assets. Changes in PCE were apparent in different socio-demographic and ocular groups. The largest PCE increases were apparent among the cases that were poorest at baseline. Conclusions/Significance This study showed that cataract surgery can contribute to poverty alleviation, particularly among the most vulnerable members of society. This study highlights the need for increased provision of cataract surgery to poor people and shows that a focus on blindness may help to alleviate poverty and achieve the Millennium Development Goals. PMID:21085697

  1. Concordance between four European centres of PET reporting criteria designed for use in multicentre trials in Hodgkin lymphoma

    Energy Technology Data Exchange (ETDEWEB)

    Barrington, Sally F.; Somer, Edward J.; O' Doherty, Michael J. [Kings College London Division of Imaging, PET Imaging Centre at St Thomas' , London (United Kingdom); Qian, Wendi [MRC Clinical Trials Unit, London (United Kingdom); Franceschetto, Antonella; Bagni, Bruno [University of Modena and Reggio Emilia, Department of Nuclear Medicine, Modena (Italy); Brun, Eva; Almquist, Helen [Lund University Hospital, Departments of Oncology and Clinical Physiology, Lund (Sweden); Loft, Annika; Hoejgaard, Liselotte [Copenhagen University Hospital, PET and Cyclotron Unit, Rigshospitalet, Copenhagen (Denmark); Federico, Massimo [University of Modena and Reggio Emilia, Department of Haematology and Oncology, Modena (Italy); Gallamini, Andrea [Azienda Ospedaliera S. Croce e Carle, Hematology Department, Cuneo (Italy); Smith, Paul [Cancer Research UK and UCL Cancer Trials Centre, London (United Kingdom); Johnson, Peter [Cancer Research UK Clinical Centre, Southampton (United Kingdom); Radford, John [The Christie NHS Foundation Trust and the University of Manchester, Manchester (United Kingdom)

    2010-10-15

    To determine if PET reporting criteria for the Response Adapted Treatment in Hodgkin Lymphoma (RATHL) trial could enable satisfactory agreement to be reached between 'core' laboratories operating in different countries. Four centres reported scans from 50 patients with stage II-IV HL, acquired before and after two cycles of Adriamycin/bleomycin/vinblastine/dacarbazine. A five-point scale was used to score response scans using 'normal' mediastinum and liver as reference levels. Centres read scans independently of each other. The level of agreement between centres was determined assuming (1) that uptake in sites involved at diagnosis that was higher than liver uptake represented disease (conservative reading), and (2) that uptake in sites involved at diagnosis that was higher than mediastinal uptake represented disease (sensitive reading). There was agreement that the response scan was 'positive' or 'negative' for lymphoma in 44 patients with a conservative reading and in 41 patients with a sensitive reading. Kappa was 0.85 (95% CI 0.74-0.96) for conservative reading and 0.79 (95% CI 0.67-0.90) for sensitive reading. Agreement was reached in 46 and 44 patients after discussion for the conservative and sensitive readings, respectively. The criteria developed for reporting in the RATHL trial are sufficiently robust to be used in a multicentre setting. (orig.)

  2. Prognostic Impact of a 12-gene Progression Score in Non-muscle-invasive Bladder Cancer: A Prospective Multicentre Validation Study.

    Science.gov (United States)

    Dyrskjøt, Lars; Reinert, Thomas; Algaba, Ferran; Christensen, Emil; Nieboer, Daan; Hermann, Gregers G; Mogensen, Karin; Beukers, Willemien; Marquez, Mirari; Segersten, Ulrika; Høyer, Søren; Ulhøi, Benedicte P; Hartmann, Arndt; Stöhr, Robert; Wach, Sven; Nawroth, Roman; Schwamborn, Kristina; Tulic, Cane; Simic, Tatjana; Junker, Kerstin; Harving, Niels; Petersen, Astrid C; Jensen, Jørgen B; Keck, Bastian; Grimm, Marc-Oliver; Horstmann, Marcus; Maurer, Tobias; Steyerberg, Ewout W; Zwarthoff, Ellen C; Real, Francisco X; Malats, Núria; Malmström, Per-Uno; Ørntoft, Torben F

    2017-09-01

    Progression of non-muscle-invasive bladder cancer (NMIBC) to muscle-invasive bladder cancer (MIBC) is life-threatening and cannot be accurately predicted using clinical and pathological risk factors. Biomarkers for stratifying patients to treatment and surveillance are greatly needed. To validate a previously developed 12-gene progression score to predict progression to MIBC in a large, multicentre, prospective study. We enrolled 1224 patients in ten European centres between 2008 and 2012. A total of 750 patients (851 tumours) fulfilled the inclusion and sample quality criteria for testing. Patients were followed for an average of 28 mo (range 0-76). A 12-gene real-time qualitative polymerase chain reaction assay was performed for all tumours and progression scores were calculated using a predefined formula and cut-off values. We measured progression to MIBC using Cox regression analysis and log-rank tests for comparing survival distributions. The progression score was significantly (prisk score, and disease progression. Univariate Cox regression analysis showed that patients molecularly classified as high risk experienced more frequent disease progression (hazard ratio 5.08, 95% confidence interval 2.2-11.6; prisk factors (prisk factors, and may help in stratifying NMIBC patients to optimise treatment and follow-up regimens. Clinical use of a 12-gene molecular test for disease aggressiveness may help in stratifying patients with non-muscle-invasive bladder cancer to optimal treatment regimens. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

  3. [Combination of acupuncture, cupping and medicine for treatment of fibromyalgia syndrome: a multi-central randomized controlled trial].

    Science.gov (United States)

    Jang, Zhen-Ya; Li, Chang-Du; Qiu, Ling; Guo, Jun-Hua; He, Ling-Na; Yue, Yang; Li, Fang-Ze; Qin, Wen-Yi

    2010-04-01

    To evaluate the clinical effect of combination of acupuncture, cupping and medicine for treatment of fibromyalgia syndrome. By using multi-central randomized controlled method, 186 cases were randomly divided into an acupuncture combined with cupping and western medicine group (group A), an acupuncture combined with cupping group (group B) and a western medicine group (group C) and treated continuously for 4 weeks. The treatment of acupuncture combined with cupping was produced by acupuncture at five mental points and moving cupping on the Hechelu of the back, once evrey other day, thrice each week, and the western medicine therapy by oral administration of Amitriptyline, once each day. The scores of McGill Pain Questionnaire (MPQ), the amount of tenderness point and the time of producing effect were compared and the therapeutic effects were assessed with the Hamilton Depression Scale (HAMD). The cured and markedly effective rate was 65.0% (39/60) in the group A, which was superior to 15.9% (10/63) in the group B and 16.1% (9/56) in the group C (both P cupping and medicine on fibromyalgia syndrome is superior to that of the simple acupuncture combined with cupping or the simple medicine.

  4. Erectile dysfunction and quality of life in men receiving methadone or buprenorphine maintenance treatment. A cross-sectional multicentre study.

    Directory of Open Access Journals (Sweden)

    Fabio Lugoboni

    Full Text Available Erectile dysfunction (ED is common among men on opioid replacement therapy (ORT, but most previous studies exploring its prevalence and determinants yielded contrasting findings. Moreover, the impact of ED on patients' quality of life (QoL has been seldom explored.To explore the prevalence and determinants of ED in men on ORT, and the impact on QoL.In a multicentre cross-sectional study, we recruited 797 consecutive male patients on methadone and buprenorphine treatment, collected data on demographic, clinical, and psychopathological factors, and explored their role as predictors of ED and QoL through univariate and multivariate analysis. ED severity was assessed with a self-assessment questionnaire.Nearly half of patients in our sample were sexually inactive or reported some degree of ED. Some demographic, clinical and psychopathological variables significantly differed according to the presence or absence of ED. Multivariate regression analysis indicated that age, employment, smoke, psychoactive drugs, opioid maintenance dosage, and severity of psychopathological factors significantly influenced the risk and severity of ED. QoL was worse in patients with ED and significantly correlated with ED severity. Age, education, employment, opioid maintenance dosage, ED score, and severity of psychopathology significantly influenced QoL in the multivariate analysis.ED complaints can be explored in male opioid users on ORT through a simple and quick self-assessment tool. ED may have important effects on emotional and social well-being, and may affect outcome.

  5. A multicentre observational study to evaluate a new tool to assess emergency physicians' non-technical skills.

    Science.gov (United States)

    Flowerdew, Lynsey; Gaunt, Arran; Spedding, Jessica; Bhargava, Ajay; Brown, Ruth; Vincent, Charles; Woloshynowych, Maria

    2013-06-01

    To evaluate a new tool to assess emergency physicians' non-technical skills. This was a multicentre observational study using data collected at four emergency departments in England. A proportion of observations used paired observers to obtain data for inter-rater reliability. Data were also collected for test-retest reliability, observability of skills, mean ratings and dispersion of ratings for each skill, as well as a comparison of skill level between hospitals. Qualitative data described the range of non-technical skills exhibited by trainees and identified sources of rater error. 96 assessments of 43 senior trainees were completed. At a scale level, intra-class coefficients were 0.575, 0.532 and 0.419 and using mean scores were 0.824, 0.702 and 0.519. Spearman's ρ for calculating test-retest reliability was 0.70 using mean scores. All skills were observed more than 60% of the time. The skill Maintenance of Standards received the lowest mean rating (4.8 on a nine-point scale) and the highest mean was calculated for Team Building (6.0). Two skills, Supervision & Feedback and Situational Awareness-Gathering Information, had significantly different distributions of ratings across the four hospitals (ptechnical skills, especially in relation to leadership. The framework of skills may be used to identify areas for development in individual trainees, as well as guide other patient safety interventions.

  6. Beneficial effect of resin salve in treatment of severe pressure ulcers: a prospective, randomized and controlled multicentre trial.

    Science.gov (United States)

    Sipponen, A; Jokinen, J J; Sipponen, P; Papp, A; Sarna, S; Lohi, J

    2008-05-01

    Resin salve of the Norway spruce (Picea abies) has been used in folk medicine to heal wounds and infections. To study its clinical effectiveness in the treatment of pressure ulcers of the skin. A prospective, randomized, controlled multicentre trial involving 37 patients with grade II-IV pressure ulcers in 11 primary care hospitals was carried out between 2005 and 2007. The ulcers were randomly allocated to receive either resin salve or sodium carboxymethylcellulose hydrocolloid polymer treatment. The inclusion criterion was grade II-IV pressure ulcer. Exclusion criteria were a life expectancy of less than 6 months or a malignant disease. The primary outcome measure was complete healing of the ulcer within 6 months. Secondary outcome measures were partial healing of the ulcer, and successful eradication of bacterial strains cultured from the ulcers at study entry. Thirteen patients of the resin group and nine patients of the control group completed the 6-month trial. All ulcers healed in 12 of the 13 patients (92%) in the resin group and in four of the nine patients (44%) in the control group (P=0.003; power 73%). Complete healing of the ulcers over time was significantly more common in the resin group than in the control group (P=0.013). Bacterial cultures from the ulcer area more often became negative within 1 month in the resin group. Traditional resin salve is significantly more effective in the treatment of infected and noninfected severe pressure ulcers than cellulose polymer gauzes.

  7. The Se.Ko.Ph. study: a European multicentre study on falls in elderly subjects living in residential homes

    Directory of Open Access Journals (Sweden)

    Aladar Bruno Ianes

    2017-05-01

    Full Text Available The aim was to investigate risk factors for falls in elderly people living in residential nursing homes. An observational, prospective, multicentre study was conducted between March 2010 and March 2011 investigating falls in elderly residents living in residential nursing homes (4 Italian¸ 4 French and 5 German nursing homes. A number of risk factors were assessed as well as details of the fall (dynamics, reasons, location and time of occurrence. Differences were observed between the countries related to different nursing practices. Fallers comprised 36.5% of all residents and approximately 40% were injured as a consequence. Six logistic regression models were created to assess which fallrelated variables had the most impact, and showed subjects with faecal incontinence had a lower risk of falling, while subjects afflicted with dementia and visual impairment showed an increased risk of falling. Higher Tinetti scores were found to be related to an increased fall risk. Falls in the elderly occur due to complex interactions between demographic, physical, behavioural and environmental risk factors. Differences between countries in fall rates were seen, probably due to different medical practices, use of aids and restraints, and characteristics of the populations (i.e. the Italian residents tended to be more cognitively impaired and more impaired in balance and gait compared to the French and German residents. There was evidence that subjects with a better clinical status fall more frequently, whereas non-fallers had a worse clinical status and therefore tended to be more bedridden.

  8. Thromboembolic risk in atrial flutter. The FLASIEC (FLutter Atriale Società Italiana di Ecografia Cardiovascolare) multicentre study.

    Science.gov (United States)

    Corrado, G; Sgalambro, A; Mantero, A; Gentile, F; Gasparini, M; Bufalino, R; Morabito, A; Trocino, G; Schiavina, R; Mandorla, S; Mangia, R; Tovena, D; Savino, K; Jacopi, F; Pellegrino, E M; Agostini, F; Centonze, G; Bovenzi, F; Caprino, E; Tadeo, G; Santarone, M

    2001-06-01

    Patients with atrial flutter are believed to be at lower risk of thromboembolism than patients with atrial fibrillation. However, the incidence of atrial thrombi and the need for anticoagulation in patients with atrial flutter is not well established. A prospective observational multicentre study was undertaken to assess the frequency of atrial thrombi and spontaneous echocontrast and the prevalence for aortic complex atherosclerotic lesions in a cohort of unselected patients with atrial flutter. We evaluated 134 patients (102 male, aged 70+/-9 years); exclusion criteria were history of atrial fibrillation, rheumatic mitral valve disease and mitral mechanical prosthesis. The median of atrial flutter duration was 33 days. Twelve patients had been taking warfarin for more than 7 days. One hundred and twenty-four patients (94%) underwent a transoesophageal echocardiogram, which revealed left atrial appendage thrombi in two patients (1.6%) and right atrial thrombi in one patient (1%). At least moderate left atrial echocontrast was found in 16/124 patients (13%). Complex atherosclerotic aortic plaques were detected in 10 patients (8%). Atrial flutter conversion was attempted in 93/134 patients (69%). At the 1-month follow-up, two patients experienced a thromboembolic event following restoration of sinus rhythm. Atrial thrombi and echocontrast, and complex aortic atherosclerotic plaques are relatively uncommon in patients with atrial flutter. Post-cardioversion embolism was observed in two patients in our study population.

  9. Multicentric T-cell lymphoma associated with feline leukemia virus infection in a captive namibian cheetah (Acinonyx jubatus).

    Science.gov (United States)

    Marker, Laurie; Munson, Linda; Basson, Peter A; Quackenbush, Sandra

    2003-07-01

    This case report describes a multicentric lymphoma in a 4 yr old female wildborn captive cheetah (Acinonyx jubatus) in Namibia after being housed in an enclosure adjacent to a feline leukemia virus (FeLV) infected cheetah that had previously been in contact with domestic cats. The year prior to the onset of clinical signs, the wild-born cheetah was FeLV antigen negative. The cheetah subsequently developed lymphoma, was found to be infected with FeLV, and then rapidly deteriorated and died. At necropsy, the liver, spleen, lymph nodes, and multiple other organs were extensively infiltrated with neoplastic T-lymphocytes. Feline leukemia virus DNA was identified in neoplastic lymphocytes from multiple organs by polymerase chain reaction and Southern blot analysis. Although the outcome of infection in this cheetah resembles that of FeLV infections in domestic cats, the transmission across an enclosure fence was unusual and may indicate a heightened susceptibility to infection in cheetahs. Caution should be exercised in holding and translocating cheetahs where contact could be made with FeLV-infected domestic, feral, or wild felids.

  10. Design of Lamifuse: a randomised, multi-centre controlled trial comparing laminectomy without or with dorsal fusion for cervical myeloradiculopathy

    Directory of Open Access Journals (Sweden)

    Grotenhuis J André

    2007-11-01

    Full Text Available Abstract Background laminectomy is a valuable surgical treatment for some patients with a cervical radiculomyelopathy due to cervical spinal stenosis. More recently attention has been given to motion of the spinal cord over spondylotic spurs as a cause of myelopathic changes. Immobilisation by fusion could have a positive effect on the recovery of myelopathic signs or changes. This has never been investigated in a prospective, randomised trial. Lamifuse is an acronyme for laminectomy and fusion. Methods/Design Lamifuse is a multicentre, randomised controlled trial comparing laminectomy with and without fusion in patients with a symptomatic cervical canal stenosis. The study population will be enrolled from patients that are 60 years or older with myelopathic signs and/or symptoms due to a cervical canal stenosis. A kyphotis shape of the cervical spine is an exclusion criterium. Each treatment arm needs 30 patients. Discussion This study will contribute to the discussion whether additional fusion after a cervical laminectomy results in a better clinical outcome. ISRCT number ISRCTN72800446

  11. The safety profile of perflutren microsphere contrast echocardiography during rest and stress imaging: results from an Australian multicentre cohort.

    Science.gov (United States)

    Platts, David G; Luis, Sushil A; Roper, Damian; Burstow, Darryl; Call, Tony; Forshaw, Anthony; Pascoe, Roess

    2013-12-01

    Contrast enhanced echocardiography (CEE) is utilised when sub-optimal image quality results in non-diagnostic echocardiograms. However, there have been numerous safety notices issued by regulatory authorities regarding rare but potentially serious adverse reactions (AR). This multi-centre, retrospective analysis was performed to assess the sho