Heuvelmans, Marjolein A; Vliegenthart, Rozemarijn; Oudkerk, Matthijs
Lung cancer is the leading cause of cancer-related death worldwide. In 2011, the largest lung cancer screening trial worldwide, the US National Lung Screening Trial, published a 20% decrease in lung cancer-specific mortality in the computed tomography (CT)-screened group, compared with the group screened by chest x-ray. On the basis of this trial, different US guidelines recently have recommended CT lung cancer screening. However, several questions regarding the implementation of lung cancer screening need to be answered. In Europe, several lung cancer screening trials are ongoing. It is planned to pool the results of the lung cancer screening trials in European randomized lung cancer CT screening (EUCT). By pooling of the data, EUCT hopes to be able to provide additional information for the discussion of some important issues regarding the implementation of lung cancer screening by low-dose CT, including: the determination of the optimal screen population, the comparison between a volume-based and diameter-based nodule management protocol, and the determination of optimal screen intervals.
Heuvelmans, Marjolein A; Vliegenthart, Rozemarijn; Oudkerk, Matthijs
Lung cancer is the leading cause of cancer-related death worldwide. In 2011, the largest lung cancer screening trial worldwide, the US National Lung Screening Trial, published a 20% decrease in lung cancer-specific mortality in the computed tomography (CT)-screened group, compared with the group
Bothamley, G H; Ditiu, L; Migliori, G B
Tuberculosis control depends on successful case finding and treatment of individuals infected with Mycobacterium tuberculosis. Passive case finding is widely practised: the present study aims to ascertain the consensus and possible improvements in active case finding across Europe. Recommendations...... from national guidelines were collected from 50 countries of the World Health Organization European region using a standard questionnaire. Contacts are universally screened for active tuberculosis and latent tuberculosis infection (LTBI). Most countries (>70%) screen those with HIV infection, prisoners...... and in-patient contacts. Screening of immigrants is related to their contribution to national rates of tuberculosis. Only 25 (50%) out of 50 advise a request for symptoms in their guidelines. A total of 36 (72%) out of 50 countries recommend sputum examination for those with a persistent cough; 13...
Gale, E A M; Bingley, P J; Emmett, C L
Juvenile Diabetes Federation (JDF) units or more, and a non-diabetic oral glucose tolerance test. Participants were recruited from 18 European countries, Canada, and the USA, and were randomly allocated oral modified release nicotinamide (1.2 g/m2) or placebo for 5 years. Random allocation was done...... with a pseudorandom number generator and we used size balanced blocks of four and stratified by age and national group. Primary outcome was development of diabetes, as defined by WHO criteria. Analysis was done on an intention-to-treat basis. FINDINGS: There was no difference in the development of diabetes between...... secretion. INTERPRETATION: Large-scale controlled trials of interventions designed to prevent the onset of type 1 diabetes are feasible, but nicotinamide was ineffective at the dose we used....
Schilling, C.; Stoeckli, S. J.; Haerle, S. K.
Purpose: Optimum management of the N0 neck is unresolved in oral cancer. Sentinel node biopsy (SNB) can reliably detect microscopic lymph node metastasis. The object of this study was to establish whether the technique was both reliable in staging the N0 neck and a safe oncological procedure...... in patients with early-stage oral squamous cell carcinoma. Methods: An European Organisation for Research and Treatment of Cancer-approved prospective, observational study commenced in 2005. Fourteen European centres recruited 415 patients with radiologically staged T1-T2N0 squamous cell carcinoma. SNB...... was undertaken with an average of 3.2 nodes removed per patient. Patients were excluded if the sentinel node (SN) could not be identified. A positive SN led to a neck dissection within 3 weeks. Analysis was performed at 3-year follow-up. Results: An SN was found in 99.5% of cases. Positive SNs were found in 23...
As part of the Update of the European Strategy for Particle Physics, the European Strategy Preparatory Group (ESPG) welcomes submissions on issues related to the strategy from individual physicists, from groups of scientists representing a community (an experiment, a topic of theoretical research, etc.) as well as from Institutions and Organizations (funding agencies, ministries, etc). These contributions will be discussed at the meetings of the Preparatory Group and during the Open Symposium to be held on 10-12 September 2012 in Cracow, and will be made available to the Strategy Group for drafting the Update of the Strategy. How to submit a contribution? Send your contribution on the scientific issues below using the form under http://indico.cern.ch/event/espg_input (preferably as an attached PDF file): - Accelerator Physics - Astroparticle Physics, Gravitation and Cosmology - Flavour Physics and Symmetries - Physics at High Energy Frontier - Physics of Neutrinos - Strong Interaction Physics...
Clinical end points for drug treatment trials in BCR-ABL1-negative classic myeloproliferative neoplasms: consensus statements from European LeukemiaNET (ELN) and Internation Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT).
Barosi, G; Tefferi, A; Besses, C; Birgegard, G; Cervantes, F; Finazzi, G; Gisslinger, H; Griesshammer, M; Harrison, C; Hehlmann, R; Hermouet, S; Kiladjian, J-J; Kröger, N; Mesa, R; Mc Mullin, M F; Pardanani, A; Passamonti, F; Samuelsson, J; Vannucchi, A M; Reiter, A; Silver, R T; Verstovsek, S; Tognoni, G; Barbui, T
The discovery of somatic mutations, primarily JAK2V617F and CALR, in classic BCR-ABL1-negative myeloproliferative neoplasms (MPNs) has generated interest in the development of molecularly targeted therapies, whose accurate assessment requires a standardized framework. A working group, comprised of members from European LeukemiaNet (ELN) and International Working Group for MPN Research and Treatment (IWG-MRT), prepared consensus-based recommendations regarding trial design, patient selection and definition of relevant end points. Accordingly, a response able to capture the long-term effect of the drug should be selected as the end point of phase II trials aimed at developing new drugs for MPNs. A time-to-event, such as overall survival, or progression-free survival or both, as co-primary end points, should measure efficacy in phase III studies. New drugs should be tested for preventing disease progression in myelofibrosis patients with early disease in randomized studies, and a time to event, such as progression-free or event-free survival should be the primary end point. Phase III trials aimed at preventing vascular events in polycythemia vera and essential thrombocythemia should be based on a selection of the target population based on new prognostic factors, including JAK2 mutation. In conclusion, we recommended a format for clinical trials in MPNs that facilitates communication between academic investigators, regulatory agencies and drug companies.
The "Vector Fields European user group meeting" will take place at CERN on 26 and 27 September 2007. Within this framework two workshops are organized at the CERN Training Centre: 24 September 2007 Modelling Magnets with Opera 25 September 2007 Modelling of Charged Particle Beam Devices with Opera If you are interested in attending the workshop or the user group meeting please contact Julie Shepherd (Vector Fields) or Pierre Baehler (CERN) directly at: Julie.Shepherd@vectorfields.co.uk, +44 (0) 1865 854933 or +44 (0) 1865 370151 Pierre.Baehler@cern.ch, 75016 / 160156.
Segal, B.H.; Herbrecht, R.; Stevens, D.A.; Ostrosky-Zeichner, L.; Sobel, J.; Viscoli, C.; Walsh, T.J.; Maertens, J.; Patterson, T.F.; Perfect, J.R.; Dupont, B.; Wingard, J.R.; Calandra, T.; Kauffman, C.A.; Graybill, J.R.; Baden, L.R.; Pappas, P.G.; Bennett, J.E.; Kontoyiannis, D.P.; Cordonnier, C.; Viviani, M.A.; Bille, J.; Almyroudis, N.G.; Wheat, L.J.; Graninger, W.; Bow, E.J.; Holland, S.M.; Kullberg, B.J.; Dismukes, W.E.; Pauw, B.E. de
Invasive fungal diseases (IFDs) have become major causes of morbidity and mortality among highly immunocompromised patients. Authoritative consensus criteria to diagnose IFD have been useful in establishing eligibility criteria for antifungal trials. There is an important need for generation of
Fudge, R. E.; Fenton, C. J.
British Telecom conceived the idea of adapting their existing paging service, together with the use of existing terrestrial pagers, to yield a one way data (i.e., paging) satellite service to mobiles. The user trial of paging by satellites was successful. It demonstrated that services could be provided over a wide geographical area to low priced terminals. Many lessons were learned in unexpected areas. These include the need for extensive liaison with all users involved, especially the drivers, to ensure they understood the potential benefits. There was a significant desire for a return acknowledgement channel or even a return data channel. Above all there is a need to ensure that the equipment can be taken across European borders and legitimately used in all European countries. The next step in a marketing assessment would be to consider the impact of two way data messaging such as INMARSAT-C.
Buhr, Thomas; Hebeda, Konnie; Kaloutsi, Vassiliki; Porwit, Anna; Van der Walt, Jon; Kreipe, Hans
Background The World Health Organization classification of myeloproliferative neoplasms discriminates between essential thrombocythemia and the prefibrotic phase of primary myelofibrosis. This discrimination is clinically relevant because essential thrombocythemia is associated with a favorable prognosis whereas patients with primary myelofibrosis have a higher risk of progression to myelofibrosis or blast crisis. Design and Methods To assess the reproducibility of the classification, six hematopathologists from five European countries re-classified 102 non-fibrotic bone marrow trephines, obtained because of sustained thrombocytosis. Results Consensus on histological classification defined as at least four identical diagnoses occurred for 63% of the samples. Inter-observer agreement showed low to moderate kappa values (0.28 to 0.57, average 0.41). The percentage of unclassifiable myeloproliferative neoplasms rose from 2% to 23% when minor criteria for primary myelofibrosis were taken into account. In contrast, the frequency of primary myelofibrosis dropped from 23% to 7%, indicating that the majority of patients with a histological diagnosis of primary myelofibrosis did not fulfill the complete criteria for this disease. Thus, over 50% of cases in this series either could not be reproducibly classified or fell into the category of unclassifiable myeloproliferative neoplasms. Conclusions World Health Organization criteria for discrimination of essential thrombocythemia from prefibrotic primary myelofibrosis are poorly to only moderately reproducible and lead to a higher proportion of non-classifiable myeloproliferative neoplasms than histology alone. PMID:22058215
Field, JK; Klaveren, R; Pedersen, JH
Overview of the European randomized lung cancer CT screening trials (EUCT) is presented with regard to the implementation of CT screening in Europe; post NLST. All seven principal investigators completed a questionnaire on the epidemiological, radiological, and nodule management aspects...
Seow, Hsien-Yeang; Whelan, Patrick; Levine, Mark N; Cowan, Kathryn; Lysakowski, Barbara; Kowaleski, Brenda; Snider, Anne; Xu, Rebecca Y; Arnold, Andrew
Many oncology clinical trials departments (CTDs) are in serious fiscal deficit and their sustainability is in jeopardy. This study investigates whether the payment models used to fund industry versus cooperative group trials contribute to the fiscal deficit of a CTD. We examined the lifetime costs of all cooperative group and industry trials activated in the CTD of a cancer center between 2007 and 2011. A trial's lifetime is defined as being from the date the first patient was accrued until the last patient's actual or projected final follow-up visit. For each trial, we calculated the lifetime monthly net income, which was defined as monthly revenue minus monthly costs. Data sources included study protocols, trial budgets, and accrual data. Of the 97 trials analyzed, 64 (66%) were cooperative group trials. The pattern of lifetime net income for cooperative group trials has a positive peak during patient accrual followed by a negative trough during follow-up. In contrast, the pattern for industry trials resembled an "l" shape. The patterns reflect the differing payment models: upfront lump-sum payments (cooperative group) versus milestone payments (industry). The negative trough in the lifetime net income of a cooperative group trial occurs because follow-up costs are typically not funded or are underfunded. CTDs accrue more patients in new trials to offset that deficit. The CTD uses revenue from accrual to existing trials to cross-subsidize past trials in follow-up. As the number of patients on follow-up increases, the fiscal deficit grows larger each year, perpetuating the cycle.
Metcalf, P A; Scragg, R R K; Sundborn, G; Jackson, R
To compare dietary intakes, food servings, and cooking practices of Pacific ethnic groups with New Zealand Europeans. Daily nutrient intakes were calculated from a self-administered food frequency questionnaire from a cross-sectional health screening study. Participants were Pacific (n=954) and New Zealand European (n=1.745) people aged 35 to 74 years. Total energy intakes in Samoan and Niuean men were higher than European men, while for women, total energy intakes were significantly higher in all Pacific ethnic groups compared to New Zealand European women. Pacific men and women had lower alcohol and calcium intakes compared to New Zealand Europeans, and Pacific men had higher protein and cholesterol intakes. Pacific adults reported eating more servings of fish, chicken and bread, fewer servings of cheese and breakfast cereal per month, and boiled their meat more often than European adults. Substantial differences in dietary habits and cooking practices exist between European and the different Pacific adult groups mainly related to the frequency of consumption of certain food/nutrient groups and greater serving sizes in Pacific compared to New Zealand European adults. Implications Strategies targeting serving sizes and frequency of consumption of specific food groups may help address the major ethnic disparities in nutrition-related health problems in New Zealand.
Derkx, B.; Wittes, J.; McCloskey, R.
Meningococcal septic shock has a rapid onset and characteristic skin hemorrhages that allow bedside diagnosis. Initial plasma endotoxin levels are high and correlate closely with clinical outcome. In a double-blind, randomized, placebo-controlled trial (planned, n = 270; actual, n = 269), we
Hermansson, Henrik Alf Jonas
interest groups, unique issue-level data on the expertise held by interest groups, their privileged access and their resources, this paper evaluates whether it is the technical information provided by groups, their insider status or their ability to put pressure on the European institutions that form......Interest groups exist largely to raise awareness of particular problems or to avoid regulation by keeping items off the political agenda, it is a major component of their raison d'être. At the earliest stages of the European policy process, the European Commission presents an agenda in the form...... of a "call for consultation" which interest groups attempt to influence. Groups that have had a role in setting the Commission's agenda will likely show most satisfaction with the agenda, used here as a way to examine their agenda-setting power. Based on a novel dataset covering 190 policy issues and 469...
Pettilä, Ville; Hjortrup, Peter B; Jakob, Stephan M
PURPOSE: The interpretation of septic shock trial data is profoundly affected by patients, control intervention, co-interventions and selected outcome measures. We evaluated the reporting of control groups in recent septic shock trials. METHODS: We searched for original articles presenting...... randomized clinical trials (RCTs) in adult septic shock patients from 2006 to 2016. We included RCTs focusing on septic shock patients with at least two parallel groups and at least 50 patients in the control group. We selected and evaluated data items regarding patients, control group characteristics...... % the proportion of patients with elevated lactate values. Five studies (21 %) provided data to estimate the proportion of septic shock patients fulfilling the Sepsis-3 definition. The mean data completeness score was 19 out of 36 (range 8-32). Of 18 predefined control group characteristics, a mean of 8 (range 2...
Field, John K.; van Klaveren, Rob; Pedersen, Jesper H.; Pastorino, Ugo; Paci, Eugino; Becker, Nikolauss; Infante, Maurizo; Oudkerk, Matthijs; de Koning, Harry J.
Overview of the European randomized lung cancer CT screening trials (EUCT) is presented with regard to the implementation of CT screening in Europe; post NLST. All seven principal investigators completed a questionnaire on the epidemiological, radiological, and nodule management aspects of their
Lambers Heerspink, Hiddo J.; Dobre, Daniela; Hillege, Hans L.; Grobbee, Diederick E.; de Zeeuw, Dick
AIMS To facilitate and improve clinical research within Europe, the European Union (EU) adopted in 2001 the Clinical Trials Directive (EUCTD). The aim of this study was to compare duration between submission of a clinical drug trial application and approval by regulatory authorities in EU countries
ESGI (European Study Group with Industry) is Europe's leading workshop for interaction between mathematicians and industry. These workshops have taken place in Great Britain for a number of years, going back to 1968 when Prof. Alan Tayler initiated the so-called Oxford Study Group with Industry...... expertise.Danfoss wanted a an analysis and optimization of a scroll compressor.DANISCO wanted a model for the heat and moisture transport in sugar silos.Danish Maritime Institute wanted to optimize a dynamical position system in order to keep a wessel stationary on the surface of the ocean.Grundfos wanted...
Application of the 2008 definitions for invasive fungal diseases to the trial comparing voriconazole versus amphotericin B for therapy of invasive aspergillosis: a collaborative study of the Mycoses Study Group (MSG 05) and the European Organization for Research and Treatment of Cancer Infectious Diseases Group.
Herbrecht, Raoul; Patterson, Thomas F; Slavin, Monica A; Marchetti, Oscar; Maertens, Johan; Johnson, Elizabeth M; Schlamm, Haran T; Donnelly, J Peter; Pappas, Peter G
Strict definition of invasive aspergillosis (IA) cases is required to allow precise conclusions about the efficacy of antifungal therapy. The Global Comparative Aspergillus Study (GCAS) compared voriconazole to amphotericin B (AmB) deoxycholate for the primary therapy of IA. Because predefined definitions used for this trial were substantially different from the consensus definitions proposed by the European Organization for Research and Treatment of Cancer/Mycoses Study Group in 2008, we recategorized the 379 episodes of the GCAS according to the later definitions. The objectives were to assess the impact of the current definitions on the classification of the episodes and to provide comparative efficacy for probable/proven and possible IA in patients treated with either voriconazole or AmB. In addition to original data, we integrated the results of baseline galactomannan serum levels obtained from 249 (65.7%) frozen samples. The original response assessment was accepted unchanged. Recategorization allowed 59 proven, 178 probable, and 106 possible IA cases to be identified. A higher favorable 12-week response rate was obtained with voriconazole (54.7%) than with AmB (29.9%) (P voriconazole for mycologically documented (probable/proven) IA (70.2%) than with AmB (54.9%) (P = .010). Higher response rates were obtained in possible IA treated with voriconazole vs AmB with the same magnitude of difference (26.2%; 95% confidence interval [CI], 7.2%-45.3%) as in mycologically documented episodes (24.3%; 95% CI, 11.9%-36.7%), suggesting that possible cases are true IA. Recategorization resulted in a better identification of the episodes and confirmed the higher efficacy of voriconazole over AmB deoxycholate in mycologically documented IA. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: email@example.com.
Orchiectomy and orchiectomy plus mitomycin C for metastatic prostate cancer in patients with poor prognosis: the final results of a European Organization for Research in Cancer Therapy Genitourinary Group Trial
de Reijke, T. M.; Keuppens, F. I.; Whelan, P.; Kliment, J.; Robinson, M. R.; Rea, L. A.; Sylvester, R. J.
The outcome of patients with symptomatic metastatic prostate cancer is poor and improved treatment regimens are urgently needed. Theoretically, the combination of orchiectomy and chemotherapy could reduce androgen sensitive and insensitive cells in the prostate. This European Organization for
Full Text Available Advances in sarcoma treatment are largely based on investigator-initiated, multicentric and interdisciplinary clinical trials. The EU's Good Clinical Practice Directive 2001/20/EC, effective since 2004, was meant to harmonize the conditions for clinical trials across Europe, but, instead, the challenge of initiating and running multinational, noncommercial clinical trials has become greater than ever. Institutions participating in existing noncommercial Pan-European studies are struggling to cope with increased administrative and financial burdens, and few new studies are initiated any more. The aim of a conference entitled Ã¢Â€ÂœPan-European Sarcoma Trials: Moving Forward in a Climate of Increasing Economic and Regulatory Pressure,Ã¢Â€Â held in Stuttgart, Germany, 30 NovemberÃ¢Â€Â“2 December 2006 as part of the European Science Foundation's ECT-program, was not only to provide an overview of currently active and planned multinational studies on osteo-, Ewing's, and soft tissue sarcoma, but also to draw on areas of synergy between various established sarcoma groups in Europe to define plausible survival strategies for collaborative, interdisciplinary, patient-oriented research.
Patient, lesion, and procedural variables as risk factors for luminal re-narrowing after successful coronary angioplasty: a quantitative analysis in 653 patients with 778 lesions. Multicenter European Research Trial with Cilazapril after Angioplasty to prevent Transluminal Coronary Obstruction and Restenosis (MERCATOR) Study Group
Hermans, W. R.; Rensing, B. J.; Foley, D. P.; Tijssen, J. G.; Rutsch, W.; Emanuelsson, H.; Danchin, N.; Wijns, W.; Chappuis, F.; Serruys, P. W.
Follow-up angiography at 6 months was obtained in 94% of the 693 patients (778 successfully dilated coronary lesions) enrolled in the Multicenter European Research trial with Cilazapril after Angioplasty to prevent Transluminal Coronary Obstruction and Restenosis (MERCATOR) trial--a double-blind,
Volavka, Jan; Czobor, Pal; Derks, Eske M.; Bitter, Istvan; Libiger, Jan; Kahn, René S.; Fleischhacker, W. Wolfgang; Kahn, R. S.; Fleischhacker, W. W.; Boter, H.; Keet, I. P. M.; Brugman, C.; Davidson, M.; Dollfus, S.; Gaebel, W.; Galderisi, S.; Gheorghe, M.; Gonen, I.; Grobbee, D. E.; Hranov, L. G.; Hummer, M.; Libiger, J.; Králové, Hradec; Lindefors, N.; López-Ibor, J. J.; Nijssen, K.; Peuskens, J.; Prelipceanu, D.; Riecher-Rössler, A.; Rybakowski, J. K.; Sedvall, G.; von Wilmsdorff, M.
To compare the effects of haloperidol, amisulpride, olanzapine, quetiapine, and ziprasidone on hostility in first-episode schizophrenia, schizoaffective disorder, or schizophreniform disorder. We used the data acquired in the European First-Episode Schizophrenia Trial, an open, randomized trial
Ten-Year Progression-Free and Overall Survival in Patients With Unresectable or Metastatic GI Stromal Tumors: Long-Term Analysis of the European Organisation for Research and Treatment of Cancer, Italian Sarcoma Group, and Australasian Gastrointestinal Trials Group Intergroup Phase III Randomized Trial on Imatinib at Two Dose Levels
Casali, P.G.; Zalcberg, J.; Cesne, A. Le; Reichardt, P.; Blay, J.Y.; Lindner, L.H.; Judson, I.R.; Schoffski, P.; Leyvraz, S.; Italiano, A.; Grunwald, V.; Pousa, A.L.; Kotasek, D.; Sleijfer, S.; Kerst, J.M.; Rutkowski, P.; Fumagalli, E.; Hogendoorn, P.; Litiere, S.; Marreaud, S.; Graaf, W.T.A. van der; Gronchi, A.; Verweij, J.
Purpose To report on the long-term results of a randomized trial comparing a standard dose (400 mg/d) versus a higher dose (800 mg/d) of imatinib in patients with metastatic or locally advanced GI stromal tumors (GISTs). Patients and Methods Eligible patients with advanced CD117-positive GIST from
Krege, Susanne; Beyer, Jörg; Souchon, Rainer
OBJECTIVES: The first consensus report presented by the European Germ Cell Cancer Consensus Group (EGCCCG) in the year 2004 has found widespread approval by many colleagues throughout the world. In November 2006, the group met a second time under the auspices of the Department of Urology of the A......OBJECTIVES: The first consensus report presented by the European Germ Cell Cancer Consensus Group (EGCCCG) in the year 2004 has found widespread approval by many colleagues throughout the world. In November 2006, the group met a second time under the auspices of the Department of Urology...... in 2004 remain valid 3 yr later, refinements in the treatment of early- and advanced-stage testicular cancer have emerged from clinical trials. Despite technical improvements, expert clinical skills will continue to be one of the major determinants for the prognosis of patients with germ cell cancer...
Ofori-Adjei David; Zijenah Lynn; Ndounga Mathieu; Ambene Herman PA; Kitua Andrew Y; Jaoko Walter G; Corrah Tumani; Ndumbe Peter M; Manyando Christine; Matee Mecky I; Agwale Simon; Shongwe Steven; Nyirenda Thomas; Makanga Michael
Abstract Background European and Developing Countries Clinical Trials Partnership (EDCTP) was founded in 2003 by the European Parliament and Council. It is a partnership of 14 European Union (EU) member states, Norway, Switzerland, and Developing Countries, formed to fund acceleration of new clinical trial interventions to fight the human immunodeficiency virus and acquired immune deficiency syndrome (HIV/AIDS), malaria and tuberculosis (TB) in the sub-Saharan African region. EDCTP seeks to b...
Henry, James A; Loovis, Carl; Montero, Melissa; Kaelin, Christine; Anselmi, Kathryn-Anne; Coombs, Rebecca; Hensley, June; James, Kenneth E
.... We conducted a randomized clinical trial to test the hypothesis that group educational counseling based on TRT principles would effectively treat veterans who have clinically significant tinnitus...
Full Text Available Group authentication aims at facilitating efficient authentication of a group of provers by a group of verifiers. A new group authentication scheme is proposed to improve the security of existent asynchronous group authentication schemes and to achieve better computational performance. The new scheme allows any groups of legitimate members to execute multiple authentication trials even under the participation of active attackers.
Krege, Susanne; Beyer, Jörg; Souchon, Rainer
OBJECTIVES: The first consensus report that had been presented by the European Germ Cell Cancer Consensus Group (EGCCCG) in 2004 has found widespread approval by many colleagues throughout the world. In November 2006, the group met a second time under the auspices of the Department of Urology...... trials. Despite technical improvements, expert clinical skills will continue to be one of the major determinants for the prognosis of patients with germ cell cancer. In addition, the particular needs of testicular cancer survivors have been acknowledged Udgivelsesdato: 2008/3...
Tian, Chao; Kosoy, Roman; Nassir, Rami; Lee, Annette; Villoslada, Pablo; Klareskog, Lars; Hammarström, Lennart; Garchon, Henri-Jean; Pulver, Ann E.; Ransom, Michael; Gregersen, Peter K.; Seldin, Michael F.
The definition of European population genetic substructure and its application to understanding complex phenotypes is becoming increasingly important. In the current study using over 4000 subjects genotyped for 300 thousand SNPs we provide further insight into relationships among European population groups and identify sets of SNP ancestry informative markers (AIMs) for application in genetic studies. In general, the graphical description of these principal components analyses (PCA) of diverse European subjects showed a strong correspondence to the geographical relationships of specific countries or regions of origin. Clearer separation of different ethnic and regional populations was observed when northern and southern European groups were considered separately and the PCA results were influenced by the inclusion or exclusion of different self-identified population groups including Ashkenazi Jewish, Sardinian and Orcadian ethnic groups. SNP AIM sets were identified that could distinguish the regional and ethnic population groups. Moreover, the studies demonstrated that most allele frequency differences between different European groups could be effectively controlled in analyses using these AIM sets. The European substructure AIMs should be widely applicable to ongoing studies to confirm and delineate specific disease susceptibility candidate regions without the necessity to perform additional genome-wide SNP studies in additional subject sets. PMID:19707526
Tian, Chao; Kosoy, Roman; Nassir, Rami; Lee, Annette; Villoslada, Pablo; Klareskog, Lars; Hammarström, Lennart; Garchon, Henri-Jean; Pulver, Ann E; Ransom, Michael; Gregersen, Peter K; Seldin, Michael F
The definition of European population genetic substructure and its application to understanding complex phenotypes is becoming increasingly important. In the current study using over 4,000 subjects genotyped for 300,000 single-nucleotide polymorphisms (SNPs), we provide further insight into relationships among European population groups and identify sets of SNP ancestry informative markers (AIMs) for application in genetic studies. In general, the graphical description of these principal components analyses (PCA) of diverse European subjects showed a strong correspondence to the geographical relationships of specific countries or regions of origin. Clearer separation of different ethnic and regional populations was observed when northern and southern European groups were considered separately and the PCA results were influenced by the inclusion or exclusion of different self-identified population groups including Ashkenazi Jewish, Sardinian, and Orcadian ethnic groups. SNP AIM sets were identified that could distinguish the regional and ethnic population groups. Moreover, the studies demonstrated that most allele frequency differences between different European groups could be controlled effectively in analyses using these AIM sets. The European substructure AIMs should be widely applicable to ongoing studies to confirm and delineate specific disease susceptibility candidate regions without the necessity of performing additional genome-wide SNP studies in additional subject sets.
Gumuchian, Stephanie T; Delisle, Vanessa C; Kwakkenbos, Linda; Pépin, Mia; Carrier, Marie-Eve; Malcarne, Vanessa L; Peláez, Sandra; El-Baalbaki, Ghassan; Thombs, Brett D
The objectives were to identify reasons why patients attend scleroderma support groups and to ascertain preferences for how meetings are best organized. The survey included 30-items on reasons for attending and nine items on organizational preferences. Patients were recruited through European patient organizations. Exploratory factor analysis was used to group reasons for attendance thematically. About 213 scleroderma patients (192 women) completed the survey. A three-factor model best described reasons for attending [χ2(348) = 586.1, p support, (2) learning about treatment and symptom management strategies, and (3) discussing other aspects of scleroderma. Among organizational preferences, respondents emphasized that meetings should include educational aspects and the opportunity to share information and support. People with scleroderma attend support groups to give and obtain social support and for education about managing their disease and other aspects of living with scleroderma. Support groups should be structured to facilitate both educational and informational aspects and to provide opportunities for sharing and support between members. Implications for rehabilitation Local peer-led support groups are an important support and informational resource for patients living with scleroderma. People with scleroderma attend support groups in order to: (1) obtain interpersonal and social support, (2) learn about disease treatment and symptom management strategies, and (3) discuss other aspects of living with scleroderma outside of symptom management. Most support group members prefer groups with a trained facilitator, that include family members or loved ones in the groups, that include between 11and 20 members, that last between 1 and 2 h, and that meet once every 1-3 months. Rehabilitation professionals can support the formation and management of local support groups or can refer patients to national scleroderma patient organizations for information on
Gonadal function in males after chemotherapy for early-stage Hodgkin's lymphoma treated in four subsequent trials by the European Organisation for Research and Treatment of Cancer: EORTC Lymphoma Group and the Groupe d'Etude des Lymphomes de l'Adulte.
van der Kaaij, Marleen A E; Heutte, Natacha; Le Stang, Nolwenn; Raemaekers, John M M; Simons, Arnold H M; Carde, Patrice; Noordijk, Evert M; Fermé, Christophe; Thomas, José; Eghbali, Houchingue; Kluin-Nelemans, Hanneke C; Henry-Amar, Michel
To analyze fertility in male patients treated with various combinations of radiotherapy and chemotherapy, with or without alkylating agents, or with radiotherapy alone for Hodgkin's lymphoma. Follicle-stimulating hormone (FSH) levels were measured in patients with early-stage upper-diaphragmatic disease enrolled in four European Organisation for Research and Treatment of Cancer (EORTC) trials (H6-H9). Median follow-up after therapy was 32 months. Patients with FSH measurement at least 12 months after end of treatment (n = 355) were selected to assess post-treatment fertility. Patients with FSH measurement 0 to 9 months after therapy (n = 349) were selected to analyze fertility recovery; of these, patients with elevated FSH (> 10 U/L; n = 101) were followed until recovery. Factors predictive for therapy-related infertility were assessed by logistic regression. The proportion of elevated FSH was 3% and 8% in patients treated with radiotherapy only or with nonalkylating chemotherapy (doxorubicin, bleomycin, vinblastine, dacarbazine [ABVD], epirubicin, bleomycin, vinblastine, prednisone [EBVP]); it was 60% (P < .001) after chemotherapy containing alkylating agents (mechlorethamine, vincristine, procarbazine, prednisone [MOPP], MOPP/doxorubicin, bleomycin, vinblastine [ABV], bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone [BEACOPP]). After a median time of 19 months, recovery of fertility occurred in 82% of patients treated without alkylating chemotherapy. This proportion was 30%, statistically (P < .001) lower in those treated with alkylating chemotherapy, and median time to recovery was 27 months. The post-treatment proportion of elevated FSH increased significantly (P < .001) with the dose of alkylating chemotherapy administered, and recovery was less frequent and slower after higher doses. Age more than 50 years and stage II disease also contributed to poor outcome. Fertility can be secured after nonalkylating chemotherapy
Münch, A; Aust, D; Bohr, J; Bonderup, O; Fernández Bañares, F; Hjortswang, H; Madisch, A; Munck, L K; Ström, M; Tysk, C; Miehlke, S
Microscopic colitis (MC) is an inflammatory bowel disease presenting with chronic, non-bloody watery diarrhoea and few or no endoscopic abnormalities. The histological examination reveals mainly two subtypes of MC, lymphocytic or collagenous colitis. Despite the fact that the incidence in MC has been rising over the last decades, research has been sparse and our knowledge about MC remains limited. Specialists in the field have initiated the European Microscopic Colitis Group (EMCG) with the primary goal to create awareness on MC. The EMCG is furthermore a forum with the intention to promote clinical and basic research. In this article statements and comments are given that all members of the EMCG have considered being of importance for a better understanding of MC. The paper focuses on the newest updates in epidemiology, symptoms and diagnostic criteria, pathophysiology and highlights some unsolved problems. Moreover, a new treatment algorithm is proposed on the basis of new evidence from well-designed, randomized control trials. Copyright © 2012 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.
Riegman, Peter H J; de Jong, Bas W D; Llombart-Bosch, Antonio
Today's translational cancer research increasingly depends on international multi-center studies. Biobanking infrastructure or comprehensive sample exchange platforms to enable networking of clinical cancer biobanks are instrumental to facilitate communication, uniform sample quality, and rules for exchange. The Organization of European Cancer Institutes (OECI) Pathobiology Working Group supports European biobanking infrastructure by maintaining the OECI-TuBaFrost exchange platform and organizing regular meetings. This platform originated from a European Commission project and is updated with knowledge from ongoing and new biobanking projects. This overview describes how European biobanking projects that have a large impact on clinical biobanking, including EuroBoNeT, SPIDIA, and BBMRI, contribute to the update of the OECI-TuBaFrost exchange platform. Combining the results of these European projects enabled the creation of an open (upon valid registration only) catalogue view of cancer biobanks and their available samples to initiate research projects. In addition, closed environments supporting active projects could be developed together with the latest views on quality, access rules, ethics, and law. With these contributions, the OECI Pathobiology Working Group contributes to and stimulates a professional attitude within biobanks at the European comprehensive cancer centers. Improving the fundamentals of cancer sample exchange in Europe stimulates the performance of large multi-center studies, resulting in experiments with the desired statistical significance outcome. With this approach, future innovation in cancer patient care can be realized faster and more reliably.
Bruynzeel, D P; Andersen, Klaus Ejner; Camarasa, J G
Changes to the European standard series which have taken place since the last officially recommended alterations in 1988, are explained. New to the series is the sesquiterpene lactone mix. The PPD black rubber mix and the quinoline mix have been replaced by single components; one of the p-hydroxy......-hydroxybenzoates has been left out of the paraben mix. Ethylenediamine dihydrochloride has been dropped from the series....
Pettilä, Ville; Hjortrup, Peter Buhl; Jakob, Stephan M; Wilkman, Erika; Perner, Anders; Takala, Jukka
The interpretation of septic shock trial data is profoundly affected by patients, control intervention, co-interventions and selected outcome measures. We evaluated the reporting of control groups in recent septic shock trials. We searched for original articles presenting randomized clinical trials (RCTs) in adult septic shock patients from 2006 to 2016. We included RCTs focusing on septic shock patients with at least two parallel groups and at least 50 patients in the control group. We selected and evaluated data items regarding patients, control group characteristics, and mortality outcomes, and calculated a data completeness score to provide an overall view of quality of reporting. A total of 24 RCTs were included (mean n = 287 patients and 71 % of eligible patients were randomized). Of the 24 studies, 14 (58 %) presented baseline data on vasopressors and 58 % the proportion of patients with elevated lactate values. Five studies (21 %) provided data to estimate the proportion of septic shock patients fulfilling the Sepsis-3 definition. The mean data completeness score was 19 out of 36 (range 8-32). Of 18 predefined control group characteristics, a mean of 8 (range 2-17) were reported. Only 2 (8 %) trials provided adequate data to confirm that their control group treatment represented usual care. Recent trials in septic shock provide inadequate data on the control group treatment and hemodynamic values. We propose a standardized trial dataset to be created and validated, comprising characteristics of patient population, interventions administered, hemodynamic values achieved, surrogate organ dysfunction, and mortality outcomes, to allow better analysis and interpretation of future trial results.
A.E.R. Arnold (Alfred); M.L. Simoons (Maarten); D.P. de Bono (David); J.G.P. Tijssen (Jan); P.W.J.C. Serruys (Patrick); M. Verstraete (Marc); J. Lubsen (Jacob); F.J.J. van de Werf (Frans)
textabstractBACKGROUND. The European Cooperative Study Group conducted two randomized trials in patients with suspected myocardial infarction to assess the effect of 100 mg single-chain recombinant tissue-type plasminogen activator (rt-PA, alteplase) on enzymatic infarct size, left ventricular
Prummel, Mark F.; Bakker, Annemieke; Wiersinga, Wilmar M.; Baldeschi, Lelio; Mourits, Maarten P.; Kendall-Taylor, Pat; Perros, Petros; Neoh, Chris; Dickinson, A. Jane; Lazarus, John H.; Lane, Carol M.; Heufelder, Armin E.; Kahaly, George J.; Pitz, Suzanne; Orgiazzi, Jacques; Hullo, Alain; Pinchera, Aldo; Marcocci, Claudio; Sartini, Maria S.; Rocchi, Roberto; Nardi, Marco; Krassas, Gerry E.; Halkias, A.
To improve management of patients with Graves' orbitopathy, a multi-center collaborative approach is necessary in order to have large enough sample sizes for meaningful randomized clinical trials. This is hampered by a lack of consensus on how to investigate the eye condition. The European Group on
Sprangers, M. A.; Cull, A.; Groenvold, M.; Bjordal, K.; Blazeby, J.; Aaronson, N. K.
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Study Group has adopted a modular approach to quality of life (QoL) assessment in cancer clinical trials. The core instrument (the EORTC QLQ-C30) covers a range of QoL issues relevant to a broad spectrum of
Hamasaki, Toshimitsu; Evans, Scott R; Ochiai, Toshimitsu
This book focuses on group sequential methods for clinical trials with co-primary endpoints based on the decision-making frameworks for: (1) rejecting the null hypothesis (stopping for efficacy), (2) rejecting the alternative hypothesis (stopping for futility), and (3) rejecting the null or alternative hypothesis (stopping for either futility or efficacy), where the trial is designed to evaluate whether the intervention is superior to the control on all endpoints. For assessing futility, there are two fundamental approaches, i.e., the decision to stop for futility based on the conditional probability of rejecting the null hypothesis, and the other based on stopping boundaries using group sequential methods. In this book, the latter approach is discussed. The book also briefly deals with the group sequential methods for clinical trials designed to evaluate whether the intervention is superior to the control on at least one endpoint. In addition, the book describes sample size recalculation and the resulting ef...
Tyndall, Alan; Ladner, Ulf M; Matucci-Cerinic, Marco
Systemic sclerosis has a complex pathogenesis and a multifaceted clinical spectrum without a specific treatment. Under the auspices of the European League Against Rheumatism, the European League Against Rheumatism Scleroderma Trials And Research group (EUSTAR) has been founded in Europe to foster the study of systemic sclerosis with the aim of achieving equality of assessment and care of systemic sclerosis patients throughout the world according to evidence-based principles. EUSTAR created the minimal essential data set, a simple two-page form with basic demographics and mostly yes/no answers to clinical and laboratory parameters, to track patients throughout Europe. Currently, over 7000 patients are registered from 150 centres in four continents, and several articles have been published with the data generated by the minimal essential data set. A commitment of EUSTAR is also to teaching and educating, and for this reason there are two teaching courses and a third is planned for early in 2009. These courses have built international networks among young investigators improving the quality of multicentre clinical trials. EUSTAR has organized several rounds of 'teach the teachers' to further standardize the skin scoring. EUSTAR activities have extended beyond European borders, and EUSTAR now includes experts from several nations. The growth of data and biomaterial might ensure many further fruitful multicentre studies, but the financial sustainability of EUSTAR remains an issue that may jeopardize the existence of this group as well as that of other organizations in the world.
Full Text Available The article explores Euroscepticism and the way it is utilized within the politics of Europe, analyzed upon evidence from a Eurosceptic Euro-party located in the European Parliament, namely the European Conservatives and Reformists Group (ECR. The aim of this article is to clarify that the selected party> disproves the argument of EU- criticism being an unfavourable condition, and, more importantly, its contribution to the political contestation in the EU. For such an assessment, a survey of the party> manifesto, party working documents, as well as the discourses of the Member of the European Parliament (MEPs will be analyzed, and the concept of Euroscepticism will be once again in the centre of this analysis. This argument is evaluated based on the transnational-level analysis of the aforementioned party, focusing primarily on three specific issues-the democratic deficit, the issue of sovereignty! and anti-immigration rhetoric.
When discussing the safety of research subjects, including their exploitation and vulnerability as well as failures in clinical research, recent commentators have focused mostly on countries with low or middle-income economies. High-income countries are seen as relatively safe and well-regulated. This article presents irregularities in clinical trials in an EU member state, Poland, which were revealed by the Supreme Audit Office of Poland (the NIK). Despite adopting many European Union regulations, including European Commission directives concerning Good Clinical Practice, these irregularities occurred. Causes as well as potential solutions to make clinical trials more ethical and safer are discussed.
Kluver, Heike; Braun, C.; Beyers, Jan
We outline a conceptual framework that identifies and characterizes the contextual nature of interest group politics in the European Union (EU) to better understand variation in interest group mobilization, lobbying strategies and interest group influence. We focus on two sets of contextual factors
Gerke, Oke; Vilstrup, Mie H; Halekoh, Ulrich
and the final analysis. Other partitions did not suggest early stopping after adjustment for multiple testing due to one influential outlier and our small sample size. CONCLUSIONS: Group-sequential testing may enable early stopping of a trial, allowing for potential time and resource savings. The testing...
Murray, Elizabeth; McAdam, Rodney; Burke, Moira T
The objective of this paper is to critique emerging legislation in the pharmaceutical industry, focusing on the clinical trials sector. Possible changes are identified and discussed inrelation to their impact on phase I clinical trials conducted in the UK. It is concluded that smaller contract research organisations, which have benefited in the past from European Union legislative variation, may have resource problems in trying to cope with the changing business environment created through legislative harmonization. These SMEs must use this opportunity to seek clinical trials research partnerships in a new harmonized EU market.
Lynge, Elsebeth; Rebolj, Matejka
Six European, randomized, controlled trials that will compare human papillomavirus (HPV) testing with cytological testing for cervical screening are under way. We reviewed the results published so far to compare the benefits and costs for participating women. At baseline screening, use of HPV...... for each extra detected CIN2+ case; although, in another trial, this number was 49 in women > or =35 years of age. The outcome of HPV testing versus cytological testing depends not only on the relative accuracy of the primary test but also on how radical the different triage procedures are. In two trials...... of a switch from primary screening with cytological testing to primary screening with HPV testing....
Wilson, Travis; Karimpour, Ramin; Rodkin, Philip C.
Focusing on a sample of 382 African American (206 female) and 264 European American (132 female) students in diverse fourth and fifth grade classrooms, this study investigated three questions concerning the connections between peer groups and academic achievement during early adolescence: (a) How is group structure (i.e., hierarchy and cohesion)…
Gerke, Oke; Vilstrup, Mie H; Halekoh, Ulrich
-PET/CT measurements, illuminating the possibility of early trial termination which implicates significant potential time and resource savings. METHODS: Primary lesion maximum standardised uptake value (SUVmax) was determined twice from preoperative FDG-PET/CTs in 45 ovarian cancer patients. Differences in SUVmax were...... and the final analysis. Other partitions did not suggest early stopping after adjustment for multiple testing due to one influential outlier and our small sample size. CONCLUSIONS: Group-sequential testing may enable early stopping of a trial, allowing for potential time and resource savings. The testing...... strategy must, though, be defined at the planning stage, and sample sizes must be reasonably large at interim analysis to ensure robustness against single outliers. Group-sequential testing may have a place in accuracy and agreement studies....
Full Text Available Abstract Background Renal failure is a frequent complication of multiple myeloma and when severe is associated with a greatly increased morbidity and mortality. The principal cause of severe renal failure is cast nephropathy, a direct consequence of high concentrations of monoclonal free light chains (FLCs in patients' sera. FLC removal by extended haemodialysis, using a high cut-off dialyser, has recently been described as a novel therapeutic option. Methods The EUropean trial of free LIght chain removal by exTEnded haemodialysis in cast nephropathy (EuLITE trial is a prospective, randomised, multicentre, open label clinical trial to investigate the clinical benefits of FLC removal haemodialysis in patients with cast nephropathy, dialysis dependent acute renal failure and de novo multiple myeloma. Recruitment commenced in May 2008. In total, 90 patients will be recruited. Participants will be randomised, centrally, upon enrolment, to either trial chemotherapy and FLC removal haemodialysis or trial chemotherapy and standard high flux haemodialysis. Trial chemotherapy consists of bortezomib, doxorubicin and dexamethasone. FLC removal haemodialysis is undertaken with two Gambro HCO 1100 dialysers in series using an intensive treatment schedule. The primary outcome for the study is independence of dialysis at 3 months. Secondary outcomes are: duration of dialysis, reduction in serum FLC concentrations; myeloma response and survival. Hypothesis FLC removal haemodialysis will increase the rate of renal recovery in patients with severe renal failure secondary to cast nephropathy in de novo multiple myeloma. Trial registration ISRCTN45967602
Musterd, S.; van Kempen, R.
Segregation of minority ethnic groups is a returning issue in public and political debates in many parts of the world. This paper focuses on Western European cities and presents information on levels and dynamics of segregation. While acknowledging the measurement problems, we feel comfortable in
Glahn, K P E; Ellis, F R; Halsall, P J
, the cornerstone of successful MH treatment, is unavailable in large areas around the world thereby increasing the risk of MH fatalities in these areas. The European Malignant Hyperthermia Group collected and reviewed all guidelines available from the various MH centres in order to provide a consensus document...
Orbach, Daniel; Brennan, Bernadette; de Paoli, Angela; Gallego, Soledad; Mudry, Peter; Francotte, Nadine; van Noesel, Max; Kelsey, Anna; Alaggio, Rita; Ranchère, Dominique; de Salvo, Gian Luca; Casanova, Michela; Bergeron, Christophe; Merks, Johannes H. M.; Jenney, Meriel; Stevens, Michael C. G.; Bisogno, Gianni; Ferrari, Andrea
Infantile fibrosarcoma (IFS) is a very rare disease occurring in young infants characterised by a high local aggressiveness but overall with a favourable survival. To try to reduce the total burden of therapy, the European pediatric Soft tissue sarcoma Study Group has developed conservative
Loerbroks, A.; Stock, C.; Bosch, J.A.; Litaker, D.G.; Apfelbacher, C.J.
BACKGROUND: National vaccination coverage rates for individuals at increased risk of influenza-related complications represent a useful public health indicator of preparedness. We compared European countries regarding (i) vaccination coverage among high-risk groups and (ii) the likelihood that
Allogeneic stem cell transplantation after reduced intensity conditioning in patients with relapsed or refractory Hodgkin's lymphoma. Results of the HDR-ALLO study - a prospective clinical trial by the Grupo Español de Linfomas/Trasplante de Médula Osea (GEL/TAMO) and the Lymphoma Working Party of the European Group for Blood and Marrow Transplantation.
Sureda, Anna; Canals, Carme; Arranz, Reyes; Caballero, Dolores; Ribera, Josep Maria; Brune, Mats; Passweg, Jacob; Martino, Rodrigo; Valcárcel, David; Besalduch, Joan; Duarte, Rafael; León, Angel; Pascual, Maria Jesus; García-Noblejas, Ana; López Corral, Lucia; Xicoy, Bianca; Sierra, Jordi; Schmitz, Norbert
-Allo trial was registered in the European Clinical Trials Database (EUDRACT, https://eudract.ema.europa.eu/) with number 02-0036.
Allogeneic stem cell transplantation after reduced intensity conditioning in patients with relapsed or refractory Hodgkin’s lymphoma. Results of the HDR-ALLO study – a prospective clinical trial by the Grupo Español de Linfomas/Trasplante de Médula Osea (GEL/TAMO) and the Lymphoma Working Party of the European Group for Blood and Marrow Transplantation
Sureda, Anna; Canals, Carme; Arranz, Reyes; Caballero, Dolores; Ribera, Josep Maria; Brune, Mats; Passweg, Jacob; Martino, Rodrigo; Valcárcel, David; Besalduch, Joan; Duarte, Rafael; León, Angel; Pascual, Maria Jesus; García-Noblejas, Ana; Corral, Lucia López; Xicoy, Bianca; Sierra, Jordi; Schmitz, Norbert
the major remaining challenge in this setting. The HDR-Allo trial was registered in the European Clinical Trials Database (EUDRACT, https://eudract.ema.europa.eu/) with number 02-0036 PMID:21993674
Role of antiarrhythmic agents after myocardial infarction with special reference to the EMIAT and CAMIAT trials of amiodarone. European Myocardial Infarct Amiodarone Trial. Canadian Amiodarone Myocardial Infarction Trial.
Jafri, S M; Borzak, S; Goldberger, J; Gheorghiade, M
The role of antiarrhythmic agents in the post-MI patients has been investigated for several years. Recently, clinical trials have assessed the effects of amiodarone in the post-MI population. The Basel Antiarrhythmic Study of Infarct Survival (BASIS) trial showed a reduction in total mortality, sudden death, and life-threatening ventricular arrhythmias with amiodarone therapy. The European Myocardial Infarct Amiodarone Trial (EMIAT) did not show a mortality benefit, but amiodarone was associated with fewer antiarrhythmic deaths. The Canadian Amiodarone Myocardial Infarction Trial (CAMIAT) showed no significant impact on mortality, but arrhythmia deaths and resuscitated cardiac deaths were reduced. Amiodarone therapy after MI should be reserved for the treatment of symptomatic or sustained ventricular arrhythmias. The current data do not support routine use of amiodarone in all patients after MI.
Full Text Available The Visegrad Group celebrated its 25th anniversary in February 2016. Established as an initiative of three statesmen from the Central and Eastern European (CEE region, this cooperation has experienced booms and crises. The aim of this paper is to analyse the function of this regional integration in the years following the end of bipolar system as Visegrad Group members headed down the road to Euro-Atlantic integration. To this end, I apply different theoretical approaches and attempt to explain the influence of key former politicians as well as new scenarios for the Visegrad Group’s position in the European Union. This analysis also covers the latest foreign policy changes and challenges facing CEE due to the involvement of a wider region that creates a counter-balance to the core EU. Statistical data and official documents from the Visegrad Group’s website strengthen these findings.
This book provides an up-to-date review of the general principles of and techniques for confirmatory adaptive designs. Confirmatory adaptive designs are a generalization of group sequential designs. With these designs, interim analyses are performed in order to stop the trial prematurely under control of the Type I error rate. In adaptive designs, it is also permissible to perform a data-driven change of relevant aspects of the study design at interim stages. This includes, for example, a sample-size reassessment, a treatment-arm selection or a selection of a pre-specified sub-population. Essentially, this adaptive methodology was introduced in the 1990s. Since then, it has become popular and the object of intense discussion and still represents a rapidly growing field of statistical research. This book describes adaptive design methodology at an elementary level, while also considering designing and planning issues as well as methods for analyzing an adaptively planned trial. This includes estimation methods...
van Hest, N A; Aldridge, R W; de Vries, G; Sandgren, A; Hauer, B; Hayward, A; Arrazola de Oñate, W; Haas, W; Codecasa, L R; Caylà, J A; Story, A; Antoine, D; Gori, A; Quabeck, L; Jonsson, J; Wanlin, M; Orcau, Å; Rodes, A; Dedicoat, M; Antoun, F; van Deutekom, H; Keizer, St; Abubakar, I
In low-incidence countries in the European Union (EU), tuberculosis (TB) is concentrated in big cities, especially among certain urban high-risk groups including immigrants from TB high-incidence countries, homeless people, and those with a history of drug and alcohol misuse. Elimination of TB in European big cities requires control measures focused on multiple layers of the urban population. The particular complexities of major EU metropolises, for example high population density and social structure, create specific opportunities for transmission, but also enable targeted TB control interventions, not efficient in the general population, to be effective or cost effective. Lessons can be learnt from across the EU and this consensus statement on TB control in big cities and urban risk groups was prepared by a working group representing various EU big cities, brought together on the initiative of the European Centre for Disease Prevention and Control. The consensus statement describes general and specific social, educational, operational, organisational, legal and monitoring TB control interventions in EU big cities, as well as providing recommendations for big city TB control, based upon a conceptual TB transmission and control model.
Cottet, V; Bonithon-Kopp, C; Kronborg, O; Santos, L; Andreatta, R; Boutron-Ruault, M-C; Faivre, J
The relations between individual foods and nutrients to colorectal tumours are conflicting. Few studies have taken into account the interdependence between individual components of diet and their possible interactions. The aim of the study was to examine the associations between dietary patterns and the risk of colorectal adenoma recurrence in the European fibre-calcium intervention trial. Among the 640 patients with confirmed adenomas at the index colonoscopy, 592 had an initial dietary assessment using a diet history questionnaire. The present analysis was restricted to 277 men and 165 women without history of adenoma prior to the index colonoscopy and who completed the study. The main end point was the 3-year recurrence of adenomas. Principal component analysis was used to identify dietary patterns from 50 food groups. Ninety-two patients presented new colorectal adenomas at the 3-year colonoscopy (65 men and 27 women). In men, three meaningful dietary patterns emerged from analysis, explaining 21.3% of variability. They were called 'Mediterranean', 'Sweets and snacks' and 'High fat and proteins' patterns. None of them were significantly related to the overall recurrence of colorectal adenomas either in univariate or multivariate analyses. Among women, the 'Mediterranean', the 'Western' and the 'Snacks' patterns explained 21.9% of variability. The 'Mediterranean' pattern characterized by a high consumption of olive oil, vegetables, fruit, fish and lean meat significantly reduced adenoma recurrence [second tertile: adjusted odds ratio (OR)=0.50, 95% confidence interval (CI)=0.18-1.42; third tertile: adjusted OR=0.30, 95% CI=0.09-0.98; P for linear trend=0.04]. The 'Western' and 'Snacks' patterns were not associated with recurrence among women. In conclusion, this study suggests that the Mediterranean dietary pattern may reduce the recurrence of colorectal adenomas, at least in women. These exploratory results need to be confirmed by larger studies.
Balian, R., E-mail: firstname.lastname@example.org [Institut de Physique Théorique, CEA Saclay, 91191 Gif-sur-Yvette cedex (France); Vénéroni, M. [Institut de Physique Nucléaire, Université Paris-Sud and IN2P3-CNRS, F-91406 Orsay cedex (France)
Time-dependent expectation values and correlation functions for many-body quantum systems are evaluated by means of a unified variational principle. It optimizes a generating functional depending on sources associated with the observables of interest. It is built by imposing through Lagrange multipliers constraints that account for the initial state (at equilibrium or off equilibrium) and for the backward Heisenberg evolution of the observables. The trial objects are respectively akin to a density operator and to an operator involving the observables of interest and the sources. We work out here the case where trial spaces constitute Lie groups. This choice reduces the original degrees of freedom to those of the underlying Lie algebra, consisting of simple observables; the resulting objects are labeled by the indices of a basis of this algebra. Explicit results are obtained by expanding in powers of the sources. Zeroth and first orders provide thermodynamic quantities and expectation values in the form of mean-field approximations, with dynamical equations having a classical Lie–Poisson structure. At second order, the variational expression for two-time correlation functions separates–as does its exact counterpart–the approximate dynamics of the observables from the approximate correlations in the initial state. Two building blocks are involved: (i) a commutation matrix which stems from the structure constants of the Lie algebra; and (ii) the second-derivative matrix of a free-energy function. The diagonalization of both matrices, required for practical calculations, is worked out, in a way analogous to the standard RPA. The ensuing structure of the variational formulae is the same as for a system of non-interacting bosons (or of harmonic oscillators) plus, at non-zero temperature, classical Gaussian variables. This property is explained by mapping the original Lie algebra onto a simpler Lie algebra. The results, valid for any trial Lie group, fulfill
P. S. Kanevsky
Full Text Available Interaction between interest groups and political institutions is one of the cornerstones of the European Union policy making process. Although majority of Russian and foreign works dedicated to lobbying and decision making in the EU, concentrate on a governmental stadial system and normative procedures that regulate interest groups access to policy making centers. Such institutional approach doesn’t clarify why the EU has concrete policies, why not all interest groups are able to win, who sets the agenda and in whose interests decisions are made. Current article, using contemporary theories and research, analyzes process of interaction between interest groups and governmental structures in the EU. It also proposes explanations of wins and losses in the policy making process, trying to answer how interest groups interacts with each other and what patterns can be identified in the process of interest aggregation by governmental structures.
Hopkins, P M; Rüffert, H; Snoeck, M M
It is 30 yr since the British Journal of Anaesthesia published the first consensus protocol for the laboratory diagnosis of malignant hyperthermia susceptibility from the European Malignant Hyperthermia Group. This has subsequently been used in more than 10 000 individuals worldwide to inform use...... of anaesthetic drugs in these patients with increased risk of developing malignant hyperthermia during general anaesthesia, representing an early and successful example of stratified medicine. In 2001, our group also published a guideline for the use of DNA-based screening of malignant hyperthermia...
Full Text Available While the postglacial history of European beech (Fagus sylvatica and the plant species composition of beech forests in Central Europe are fairly well understood, the faunal biodiversity has been less well investigated. We studied three groups of mostly sedentary organisms in beech forest at regional and European scales by combining field studies with a compilation of existing literature and expert knowledge. Specifically, we examined the relationship between host tree genera and saproxylic beetles, and the diversity and composition of forest ground-dwelling molluscs and ground beetles in relation to the abundance of beech. At a west central European scale (Germany, where beech has a “young” ecological and biogeographical history, we found 48 primeval forest relict species of saproxylic beetles associated with beech, 124 ground beetles and 91 molluscs inhabiting beech forest, yet none exclusive of west central European beech forests. High levels of faunal similarity between beech and other woodland trees suggested that many of the beech forest dwelling species are euryoecious and likely to originate from mid-Holocene mixed broadleaf forests. Beech forests of the mountain ranges in southern and east central Europe, which are ecologically and biogeographically “old”, were found to harbour distinct species assemblages, including beech forest specialists (such as 10 carabid species in the Carpathians and narrow-range endemics of broadleaf forest. The observed biodiversity patterns suggest differentiated conservation priorities in “young” and “old” European beech forest regions.
Full Text Available Abstract Background European and Developing Countries Clinical Trials Partnership (EDCTP was founded in 2003 by the European Parliament and Council. It is a partnership of 14 European Union (EU member states, Norway, Switzerland, and Developing Countries, formed to fund acceleration of new clinical trial interventions to fight the human immunodeficiency virus and acquired immune deficiency syndrome (HIV/AIDS, malaria and tuberculosis (TB in the sub-Saharan African region. EDCTP seeks to be synergistic with other funding bodies supporting research on these diseases. Methods EDCTP promotes collaborative research supported by multiple funding agencies and harnesses networking expertise across different African and European countries. EDCTP is different from other similar initiatives. The organisation of EDCTP blends important aspects of partnership that includes ownership, sustainability and responds to demand-driven research. The Developing Countries Coordinating Committee (DCCC; a team of independent scientists and representatives of regional health bodies from sub-Saharan Africa provides advice to the partnership. Thus EDCTP reflects a true partnership and the active involvement and contribution of these African scientists ensures joint ownership of the EDCTP programme with European counterparts. Results The following have been the major achievements of the EDCTP initiative since its formation in 2003; i increase in the number of participating African countries from two to 26 in 2008 ii the cumulative amount of funds spent on EDCTP projects has reached € 150 m, iii the cumulative number of clinical trials approved has reached 40 and iv there has been a significant increase number and diversity in capacity building activities. Conclusion While we recognise that EDCTP faced enormous challenges in its first few years of existence, the strong involvement of African scientists and its new initiatives such as unconditional funding to regional
Matee, Mecky I; Manyando, Christine; Ndumbe, Peter M; Corrah, Tumani; Jaoko, Walter G; Kitua, Andrew Y; Ambene, Herman Pa; Ndounga, Mathieu; Zijenah, Lynn; Ofori-Adjei, David; Agwale, Simon; Shongwe, Steven; Nyirenda, Thomas; Makanga, Michael
European and Developing Countries Clinical Trials Partnership (EDCTP) was founded in 2003 by the European Parliament and Council. It is a partnership of 14 European Union (EU) member states, Norway, Switzerland, and Developing Countries, formed to fund acceleration of new clinical trial interventions to fight the human immunodeficiency virus and acquired immune deficiency syndrome (HIV/AIDS), malaria and tuberculosis (TB) in the sub-Saharan African region. EDCTP seeks to be synergistic with other funding bodies supporting research on these diseases. EDCTP promotes collaborative research supported by multiple funding agencies and harnesses networking expertise across different African and European countries. EDCTP is different from other similar initiatives. The organisation of EDCTP blends important aspects of partnership that includes ownership, sustainability and responds to demand-driven research. The Developing Countries Coordinating Committee (DCCC); a team of independent scientists and representatives of regional health bodies from sub-Saharan Africa provides advice to the partnership. Thus EDCTP reflects a true partnership and the active involvement and contribution of these African scientists ensures joint ownership of the EDCTP programme with European counterparts. The following have been the major achievements of the EDCTP initiative since its formation in 2003; i) increase in the number of participating African countries from two to 26 in 2008 ii) the cumulative amount of funds spent on EDCTP projects has reached 150 m euros, iii) the cumulative number of clinical trials approved has reached 40 and iv) there has been a significant increase number and diversity in capacity building activities. While we recognise that EDCTP faced enormous challenges in its first few years of existence, the strong involvement of African scientists and its new initiatives such as unconditional funding to regional networks of excellence in sub-Saharan Africa is envisaged to
Haake, Michael; Müller, Hans-Helge; Schade-Brittinger, Carmen; Basler, Heinz D; Schäfer, Helmut; Maier, Christoph; Endres, Heinz G; Trampisch, Hans J; Molsberger, Albrecht
To our knowledge, verum acupuncture has never been directly compared with sham acupuncture and guideline-based conventional therapy in patients with chronic low back pain. A patient- and observer-blinded randomized controlled trial conducted in Germany involving 340 outpatient practices, including 1162 patients aged 18 to 86 years (mean +/- SD age, 50 +/- 15 years) with a history of chronic low back pain for a mean of 8 years. Patients underwent ten 30-minute sessions, generally 2 sessions per week, of verum acupuncture (n = 387) according to principles of traditional Chinese medicine; sham acupuncture (n = 387) consisting of superficial needling at nonacupuncture points; or conventional therapy, a combination of drugs, physical therapy, and exercise (n = 388). Five additional sessions were offered to patients who had a partial response to treatment (10%-50% reduction in pain intensity). Primary outcome was response after 6 months, defined as 33% improvement or better on 3 pain-related items on the Von Korff Chronic Pain Grade Scale questionnaire or 12% improvement or better on the back-specific Hanover Functional Ability Questionnaire. Patients who were unblinded or had recourse to other than permitted concomitant therapies during follow-up were classified as nonresponders regardless of symptom improvement. At 6 months, response rate was 47.6% in the verum acupuncture group, 44.2% in the sham acupuncture group, and 27.4% in the conventional therapy group. Differences among groups were as follows: verum vs sham, 3.4% (95% confidence interval, -3.7% to 10.3%; P = .39); verum vs conventional therapy, 20.2% (95% confidence interval, 13.4% to 26.7%; P vs conventional therapy, 16.8% (95% confidence interval, 10.1% to 23.4%; P acupuncture treatment for at least 6 months. Effectiveness of acupuncture, either verum or sham, was almost twice that of conventional therapy.
Krege, S.; Beyer, J.; Souchon, R.; Albers, P.; Albrecht, W.; Algaba, F.; Bamberg, M.; Bodrogi, I.; Bokemeyer, C.; Cavallin-Stahl, E.; Classen, J.; Clemm, C.; Cohn-Cedermark, G.; Culine, S.; Daugaard, G.; Mulder, P.H.M. de; Santis, M. de; Wit, M. de; Wit, R. de; Derigs, H.G.; Dieckmann, K.P.; Dieing, A.; Droz, J.P.; Fenner, M.; Fizazi, K.; Flechon, A.; Fossa, S.D.; Muro, X.G. del; Gauler, T.; Geczi, L.; Gerl, A.; Germa-Lluch, J.R.; Gillessen, S.; Hartmann, J.T.; Hartmann, M.; Heidenreich, A.; Hoeltl, W.; Horwich, A.; Huddart, R.; Jewett, M.; Joffe, J.; Jones, W.G.; Kisbenedek, L.; Klepp, O.; Kliesch, S.; Koehrmann, K.U.; Kollmannsberger, C.; Kuczyk, M.; Laguna, P.; Galvis, O.L.; Loy, V.; Mason, M.D.; Mead, G.M.; Mueller, R.; Nichols, C.; Nicolai, N.; Oliver, T.; Ondrus, D.; Oosterhof, G.O.; Ares, L.P.; Pizzocaro, G.; Pont, J.; Pottek, T.; Powles, T.; Rick, O.; Rosti, G.; Salvioni, R.; Scheiderbauer, J.; Schmelz, H.U.; Schmidberger, H.; Schmoll, H.J.; Schrader, M.; Sedlmayer, F.; Skakkebaek, N.E.; Sohaib, A.; Tjulandin, S.; Warde, P.; Weinknecht, S.; Weissbach, L.; Wittekind, C.; Winter, E.; Wood, L.; Maase, H. von der
OBJECTIVES: The first consensus report presented by the European Germ Cell Cancer Consensus Group (EGCCCG) in the year 2004 has found widespread approval by many colleagues throughout the world. In November 2006, the group met a second time under the auspices of the Department of Urology of the
Krege, S.; Beyer, J.; Souchon, R.; Albers, P.; Albrecht, W.; Algaba, F.; Bamberg, M.; Bodrogi, I.; Bokemeyer, C.; Cavallin-Stahl, E.; Classen, J.; Clemm, C.; Cohn-Cedermark, G.; Culine, S.; Daugaard, G.; Mulder, P.H.M. de; Santis, M. De; Wit, M. de; Wit, R. de; Derigs, H.G.; Dieckmann, K.P.; Dieing, A.; Droz, J.P.; Fenner, M.; Fizazi, K.; Flechon, A.; Fossa, S.D.; Muro, X.G. del; Gauler, T.; Geczi, L.; Gerl, A.; Germa-Lluch, J.R.; Gillessen, S.; Hartmann, J.T.; Hartmann, M.; Heidenreich, A.; Hoeltl, W.; Horwich, A.; Huddart, R.; Jewett, M.; Joffe, J.; Jones, W.G.; Kisbenedek, L.; Klepp, O.; Kliesch, S.; Koehrmann, K.U.; Kollmannsberger, C.; Kuczyk, M.; Laguna, P.; Galvis, O.L.; Loy, V.; Mason, M.D.; Mead, G.M.; Mueller, R.; Nichols, C.; Nicolai, N.; Oliver, T.; Ondrus, D.; Oosterhof, G.O.; Paz-Ares, L.; Pizzocaro, G.; Pont, J.; Pottek, T.; Powles, T.; Rick, O.; Rosti, G.; Salvioni, R.; Scheiderbauer, J.; Schmelz, H.U.; Schmidberger, H.; Schmoll, H.J.; Schrader, M.; Sedlmayer, F.; Skakkebaek, N.E.; Sohaib, A.; Tjulandin, S.; Warde, P.; Weinknecht, S.; Weissbach, L.; Wittekind, C.; Winter, E.; Wood, L.; Maase, H. von der
OBJECTIVES: The first consensus report that had been presented by the European Germ Cell Cancer Consensus Group (EGCCCG) in 2004 has found widespread approval by many colleagues throughout the world. In November 2006, the group met a second time under the auspices of the Department of Urology of the
Nikita Aleksandrovich Lobanov
Full Text Available XXI century was marked by the strengthening of globalization and integration processes in whole world. This led to the fact that the international community, especially European countries, faced the number of new threats to the spread of Islamic terrorism, the most urgent of which is the activity of “Islamic State” grouping. In this context it’s important to determine the reasons of intense activity growth of IS and its influence in Europe. The article analyzes the factors, contributing to the spread of terrorism. Also it gives some recommendations, implementation of which, according to the author, could decrease the level of terrorist threat. The purpose of the research is to determine factors of growing influence of “Islamic State” and increasing number of terrorist attacks in European countries. The author concludes that IS problem is a comprehensive threat, to prevent which a number of efforts – both within the European continent and in Middle East – is required. It also requires a systematic approach and a high level of consolidation and coordination within the international community.
Freedland, Kenneth E; Mohr, David C; Davidson, Karina W; Schwartz, Joseph E
To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials...
During the past 10 years, many activities have taken place in the field of quality systems and accreditation in medical laboratories. Each country in Europe has a slightly different approach. The Working Group on Accreditation of the European Communities Confederation of Clinical Chemistry (EC4) tries to support harmonisation of these efforts. For this purpose, they edited the Essential Criteria for quality systems of medical laboratories and supported the forthcoming International ISO standard "Quality management for the medical laboratory". At this moment, a Model Quality Manual is nearly ready for publication. The next items are setting up criteria for auditing the quality system and criteria for the accreditation process.
Brugal, M Teresa; Borrell, Carme; Díaz-Quijano, Estela; Pasarín, M Isabel; García-Olalla, Patricia; Villalbí, Joan R
To analyse deprivation and AIDS among three AIDS transmission groups (men who have sex with men--MSM, heterosexuals, and intravenous drug users--IDUs) in Barcelona, Spain, during the period 1990-95. This is an ecological study, the unit of analysis being the neighbourhoods. Included were AIDS cases residents in Barcelona. The association among AIDS rate and deprivation was studied using Spearman correlation coefficients and Poisson regression. For MSM, inner city neighbourhood residence meant a greater risk of AIDS; but lower educational level was inversely related with AIDS rates. For heterosexuals, variables related with AIDS rates were younger age, inner city areas and social unrest for women, and extreme poverty for men. Among UDIs variables related with AIDS were unemployment and social unrest for both sexes. The association between AIDS rates and deprivation differs across transmission groups in a southern European city.
Full Text Available Abstract Background Although social environments may influence alcohol-related behaviours in youth, the relationship between neighbourhood socioeconomic context and effectiveness of school-based prevention against underage drinking has been insufficiently investigated. We study whether the social environment affects the impact of a new school-based prevention programme on alcohol use among European students. Methods During the school year 2004-2005, 7079 students 12-14 years of age from 143 schools in nine European centres participated in this cluster randomised controlled trial. Schools were randomly assigned to either control or a 12-session standardised curriculum based on the comprehensive social influence model. Randomisation was blocked within socioeconomic levels of the school environment. Alcohol use and alcohol-related problem behaviours were investigated through a self-completed anonymous questionnaire at baseline and 18 months thereafter. Data were analysed using multilevel models, separately by socioeconomic level. Results At baseline, adolescents in schools of low socioeconomic level were more likely to report problem drinking than other students. Participation in the programme was associated in this group with a decreased odds of reporting episodes of drunkenness (OR = 0.60, 95% CI = 0.44-0.83, intention to get drunk (OR = 0.60, 95% CI = 0.45-0.79, and marginally alcohol-related problem behaviours (OR = 0.70, 95% CI = 0.46-1.06. No significant programme's effects emerged for students in schools of medium or high socioeconomic level. Effects on frequency of alcohol consumption were also stronger among students in disadvantaged schools, although the estimates did not attain statistical significance in any subgroup. Conclusions It is plausible that comprehensive social influence programmes have a more favourable effect on problematic drinking among students in underprivileged social environments. Trial registration ISRCTN: ISRCTN
Full Text Available Abstract Background Traumatic brain injury is a major cause of death and severe disability worldwide with 1,000,000 hospital admissions per annum throughout the European Union. Therapeutic hypothermia to reduce intracranial hypertension may improve patient outcome but key issues are length of hypothermia treatment and speed of re-warming. A recent meta-analysis showed improved outcome when hypothermia was continued for between 48 hours and 5 days and patients were re-warmed slowly (1°C/4 hours. Previous experience with cooling also appears to be important if complications, which may outweigh the benefits of hypothermia, are to be avoided. Methods/design This is a pragmatic, multi-centre randomised controlled trial examining the effects of hypothermia 32-35°C, titrated to reduce intracranial pressure Participants are randomised to either standard care or standard care with titrated therapeutic hypothermia. Hypothermia is initiated with 20-30 ml/kg of intravenous, refrigerated 0.9% saline and maintained using each centre's usual cooling technique. There is a guideline for detection and treatment of shivering in the intervention group. Hypothermia is maintained for at least 48 hours in the treatment group and continued for as long as is necessary to maintain intracranial pressure 20 mmHg in accordance with the Brain Trauma Foundation Guidelines, 2007. Discussion The Eurotherm3235Trial is the most important clinical trial in critical care ever conceived by European intensive care medicine, because it was launched and funded by the European Society of Intensive Care Medicine and will be the largest non-commercial randomised controlled trial due to the substantial number of centres required to deliver the target number of patients. It represents a new and fundamental step for intensive care medicine in Europe. Recruitment will continue until January 2013 and interested clinicians from intensive care units worldwide can still join this important
Full Text Available This study analyses party group cohesion and patterns of defections of national party delegations from party group lines in the present European Parliament, using a total of 1,370 roll call votes. The study confirms previous findings according to which party groups in the EP show (surprisingly high levels of cohesion. In addition and notwithstanding that, it reveals the circumstances under which MEPs and their national delegations are more likely to defect. Among other factors, it was analysed how the nature of the candidate selection process, the electoral system, and the relationships between MEPs and their home parties influence these defections. Assuming that MEPs have three different goals (re-election, office, and policy and want to first of all secure re-election, one can theoretically expect that those MEPs whose chances of re-election are more dependent on national parties than others (due to their specific candidate selection process or their relationship to their home party are more willing to vote against the party group line, if a conflict between party group and national party emerges. Empirically, this is confirmed. In other words, MEPs in general are very well aware of their specific situation. They know who deserves their primary attention and they act accordingly.
Pischke Claudia R
Full Text Available Abstract Background Incorrect perceptions of high rates of peer alcohol and tobacco use are predictive of increased personal use in student populations. Correcting misperceptions by providing feedback has been shown to be an effective intervention for reducing licit drug use. It is currently unknown if social norms interventions are effective in preventing and reducing illicit drug use in European students. The purpose of this paper is to describe the design of a multi-site cluster controlled trial of a web-based social norms intervention aimed at reducing licit and preventing illicit drug use in European university students. Methods/Design An online questionnaire to assess rates of drug use will be developed and translated based on existing social norms surveys. Students from sixteen universities in seven participating European countries will be invited to complete the questionnaire. Both intervention and control sites will be chosen by convenience. In each country, the intervention site will be the university that the local principal investigator is affiliated with. We aim to recruit 1000 students per site (baseline assessment. All participants will complete the online questionnaire at baseline. Baseline data will be used to develop social norms messages that will be included in a web-based intervention. The intervention group will receive individualized social norms feedback. The website will remain online during the following 5 months. After five months, a second survey will be conducted and effects of the intervention on social norms and drug use will be measured in comparison to the control site. Discussion This project is the first cross-national European collaboration to investigate the feasibility of a social norms intervention to reduce licit and prevent illicit drug use among European university students. Final trial registration number DRKS00004375 on the ‘German Clinical Trials Register’.
Bauman, Jerry L; Talbert, Robert L
Heart failure is a growing public health problem in the United States, and the approach to the treatment of heart failure has undergone a radical transformation in the past decade. The use of beta-blocker therapy in heart failure patients is now widely recommended, based on evidence from large-scale clinical trials demonstrating that bisoprolol, carvedilol, and extended-release metoprolol succinate significantly reduce morbidity and mortality in patients with heart failure. Although these agents appear to provide similar benefits, the question remains whether pharmacologic differences among them could translate to differences in clinical outcomes. The Carvedilol Or Metoprolol European Trial (COMET) compared nonselective blockade of the beta1-/beta2-/alpha1-adrenergic receptors with carvedilol versus selective beta1-blockade with immediate-release metoprolol tartrate in patients with chronic heart failure. The trial found that carvedilol significantly reduced all-cause mortality compared with immediate-release metoprolol tartrate, although there were no differences in hospitalizations. Herein we review the pharmacokinetics and pharmacodynamics of metoprolol and carvedilol. In doing so, several issues regarding the design of COMET are identified that could alter the interpretation of the results of this trial. These include the choice of dose and dosage regimen of immediate-release metoprolol tartrate, a dosage form that has never been shown to reduce mortality in patients with heart failure. Additional studies are needed to fully understand whether there are any advantages of selective versus nonselective adrenergic blockade and whether there are any clinically meaningful differences in effectiveness between beta-blockers with proven benefit in the management of chronic heart failure. The results of COMET demonstrate that all beta-blockers and dosage forms are not interchangeable when prescribed for heart failure. Clinicians should choose only those agents (and
Bingley, Polly J; Mahon, Jeffrey L; Gale, Edwin A M
OBJECTIVE: Insulin resistance can modulate progression to type 1 diabetes in individuals with ongoing islet autoimmunity. We wanted to see whether measures of insulin resistance improved risk assessment in islet cell antibody (ICA)-positive relatives when added to other immune and metabolic markers....... RESEARCH DESIGN AND METHODS: The retrospective cohort analysis included 213 family members participating in the European Nicotinamide Diabetes Intervention Trial. All were aged or=20 Juvenile Diabetes Foundation units. Median length of follow......-up was 4.21 years, and 105 individuals developed diabetes. Oral and intravenous glucose tolerance tests were performed at baseline; antibodies to GAD, IA-2, and insulin were determined by radioimmunoassay; and insulin resistance was estimated by homeostasis model assessment. Risk was assessed by Cox...
Kelly, L; Brouwer, A; Wilson, A; Gale, P; Snary, E; Ross, David; de Vos, C J
In recent years, several animal disease epidemics have occurred within the European Union (EU). At the 4th Annual Meeting of the EPIZONE network (7-10 June 2010, St. Malo, France), an interactive session was run to elicit the opinions of delegates on a pre-defined list of epidemic threats to the EU. Responses from over 190 delegates, to questions relating to impact and likelihood, were used to rank six virus groups with respect to their perceived threat now (2010) and in 2020. The combined opinions of all delegates suggested that, from the pre-selected list of virus groups, foot-and-mouth disease and influenza are currently of most concern. Delegates thought that influenza would be less of a threat and zoonotic arboviruses would be more of a threat in 2020. Although the virus group rankings should not be taken as definitive, the results could be used in conjunction with experimental and field data, by scientists, policy-makers and stakeholders when assessing and managing risks associated with these virus groups. © 2012 Blackwell Verlag GmbH.
Full Text Available The objective of the study is to point out, what kind of measurement methodologies and factor groups are used to determinate the depth of the spatial integration in the national and international scientific literature. Integration means in this sense the interconnection of several (spatial units (Kulcsár-Rostás, 1989; Kovács, 2001; Kiss, 2005. One of the most widely interpreted types of the integration is the economic integration, which can be applied to enterprises and spatial units as well. This study focuses on the last one and examines it at three territorial levels, distinguishing global, supranational (among national states and subnational levels. The possible measurement methods are significantly determined by the spatial levels. The paper makes some suggestions for the possible measurement method in Cenrtral-European context.
Silverman, Henry J; Miller, Franklin G
Ethical concern has been raised with critical care randomized controlled trials in which the standard of care reflects a broad range of clinical practices. Commentators have argued that trials without an unrestricted control group, in which standard practices are implemented at the discretion of the attending physician, lack the ability to redefine the standard of care and might expose subjects to excessive harms due to an inability to stop early. To develop a framework for analyzing control group selection for critical care trials. Ethical analysis. A key ethical variable in trial design is the extent with which the control group adequately reflects standard care practices. Such a control group might incorporate either the "unrestricted" practices of physicians or a protocol that specifies and restricts the parameters of standard practices. Control group selection should be determined with respect to the following ethical objectives of trial design: 1) clinical value, 2) scientific validity, 3) efficiency and feasibility, and 4) protection of human subjects. Because these objectives may conflict, control group selection will involve trade-offs and compromises. Trials using a protocolized rather than an unrestricted standard care control group will likely have enhanced validity. However, if the protocolized control group lacks representativeness to standard care practices, then trials that use such groups will offer less clinical value and could provide less assurance of protecting subjects compared with trials that use unrestricted control groups. For trials evaluating contrasting strategies that do not adequately represent standard practices, use of a third group that is more representative of standard practices will enhance clinical value and increase the ability to stop early if needed to protect subjects. These advantages might come at the expense of efficiency and feasibility. Weighing and balancing the competing ethical objectives of trial design should be
Neale, Joanne; Tompkins, Charlotte N E; McDonald, Rebecca; Strang, John
To explore potential study participants' views on willingness to join clinical trials of pharmacological interventions for illicit opioid use to inform and improve future recruitment strategies. Qualitative focus group study (6 groups: oral methadone [2 groups]; buprenorphine tablets [2 groups]; injectable opioid agonist treatment [1 group]; and former opioid agonist treatment [1 group]). Drug and alcohol services and a peer support recovery service (London, United Kingdom). 40 people with experience of opioid agonist treatment for heroin dependence (26 males, 14 females; ages 33-66 years). Data collection was facilitated by a topic guide that explored willingness to enrol in clinical pharmacological trials. Groups were audio-recorded and transcribed. Transcribed data were analysed inductively via Iterative Categorisation. Participants' willingness to join pharmacological trials of medications for opioid dependence was affected by factors relating to study burden, study drug, study design, study population, and study relationships. Participants worried that the trial drug might be worse than, or interfere with, their current treatment. They also misunderstood aspects of trial design despite the researchers' explanations. Recruitment of participants for clinical trials of pharmacological interventions for illicit opioid use could be improved if researchers became better at explaining clinical trials to potential participants, dispelling misconceptions about trials, and increasing trust in the research process and research establishment. A checklist of issues to consider when designing pharmacological trials for illicit opioid use is proposed. This article is protected by copyright. All rights reserved.
Freedland, Kenneth E; Mohr, David C; Davidson, Karina W; Schwartz, Joseph E
To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials. Selective qualitative review. Extrinsic health care services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment-as-usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. This review highlights the need for a scientific consensus statement on control groups in behavioral trials.
Reviewing and addressing the link between mass media and the increase in obesity among European children: The European Academy of Paediatrics (EAP) and The European Childhood Obesity Group (ECOG) consensus statement.
Mazur, Artur; Caroli, Margherita; Radziewicz-Winnicki, Igor; Nowicka, Paulina; Weghuber, Daniel; Neubauer, David; Dembiński, Łukasz; Crawley, Francis P; White, Martin; Hadjipanayis, Adamos
This study reviewed the link between social media and the growing epidemic of childhood obesity in Europe. A task force from the European Academy of Paediatrics and the European Childhood Obesity Group searched published literature and developed a consensus statement. It found that there was evidence of a strong link between obesity levels across European countries and childhood media exposure and that parents and society needed a better understanding of the influence of social media on dietary habits. Health policies in Europe must take account of the range of social media influences that promote the development of childhood obesity. ©2017 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.
Karlsen, Anders P; Mathiesen, Ole; Dahl, Jørgen B
Postoperative analgesic interventions are often tested adjunct to basic non- opioid analgesics in randomized controlled trials (RCTs). Consequently, treatment in control groups, and assay sensitivity, differs between trials. We hypothesized that postoperative opioid requirements and pain intensities varies between different control groups in analgesic trials. Control groups from RCTs investigating analgesic interventions after total hip and knee arthroplasty were categorized based on standardized basic analgesic treatment. Morphine consumption 0-24h postoperatively, and resting pain scores at 6 and 24 hours for subgroups of basic treatments, were compared with ANOVA. In an additional analysis, we compared pain and opioid requirements in trials where NSAID was administered as an intervention with trial where NSAID was administered in a control group. We included 171 RCTs employing 28 different control groups with large variability in pain scores and opioid requirements. Four types of control groups (comprising 78 trials) were eligi- ble for subgroup comparisons. These subgroups received: 'opioid', 'NSAID+opioid', 'acetamino- phen+opioid', or 'NSAID+acetaminophen+opioid'. Morphine consumption and pain scores varied substantially between these groups, with no consistent superior efficacy in any subgroup. Addi- tionally, trials administering NSAID as an intervention demonstrated lower pain scores and opioid requirements than trials where NSAID was administered in a control group. Analgesic treatment in RCT control groups varies considerably. Control groups receiving various combinations of opioid, NSAID and acetaminophen did not differ consistently in pain and opioid requirements. Pain and opioid requirements were lower in trials administering NSAID as an intervention compared with trials administering NSAID in a control group.
Nohynek, H; Wichmann, O; D Ancona, F
During the twenty-first century, the development of national immunization programmes (NIP) has matured into robust processes where evidence-based methodologies and frameworks have increasingly been adopted. A key role in the decision-making and recommending processes is played by National Immunization Technical Advisory Groups (NITAGs). In a survey performed among European Union member states, Norway and Iceland, in February 2013, 85% of the 27 responding countries reported having established a NITAG, and of these, 45% have formal frameworks in place for the systematic development of vaccination recommendations. Independent of whether a formal framework is in place, common key factors are addressed by all NITAGs and also in countries without NITAGs. The four main factors addressed by all were: disease burden in the country, severity of the disease, vaccine effectiveness or efficacy, and vaccine safety at population level. Mathematical modelling and cost-effectiveness analyses are still not common tools. Differences in the relative weighting of these key factors, differences in data or assumptions on country-specific key factors, and differences in existing vaccination systems and financing, are likely to be reasons for differences in NITAG recommendations, and eventually NIPs, across Europe. Even if harmonization of NIPs is presently not a reasonable aim, systematic reviews and the development of mathematical/economic models could be performed at supranational level, thus sharing resources and easing the present work-load of NITAGs. Nevertheless, it has been argued that harmonization would ease central purchase of vaccines, thus reducing the price and increasing access to new vaccines. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.
Limdi, Nita A; Beasley, T Mark; Crowley, Michael R; Goldstein, Joyce A; Rieder, Mark J; Flockhart, David A; Arnett, Donna K; Acton, Ronald T; Liu, Nianjun
Although the influence of VKORC1 and CYP2C9 polymorphisms on warfarin response has been studied, variability in dose explained by CYP2C9 and VKORC1 is lower among African-Americans compared with European-Americans. This has lead investigators to hypothesize that assessment of VKORC1 haplotypes may help capture a greater proportion of the variability in dose for this under-represented group. However, the inadequate representation of African-Americans and the assessment of a few VKORC1 polymorphisms have hindered this effort. To determine if VKORC1 haplotypes or haplotype groups explain a higher variability in warfarin dose, we comprehensively assessed VKORC1 polymorphisms in 273 African-Americans and 302 European-Americans. The influence of VKORC1 polymorphisms, race-specific haplotypes and haplotype groups on warfarin dose was evaluated in race-stratified multivariable analyses after accounting for CYP2C9 (*2, *3, *5, *6 and *11) and clinical covariates. VKORC1 explained 18% (30% with CYP2C9) variability in warfarin dose among European-Americans and 5% (8% with CYP2C9) among African-Americans. Four common haplotypes in European-Americans and twelve in African-Americans were identified. In each race VKORC1 haplotypes emerged into two groups: low-dose (Group A) and high-dose (Group B). African-Americans had a lower frequency of Group A haplotype (10.6%) compared with European-Americans (35%, p haplotype or haplotype groups was similar to that of a single informative polymorphism. Our findings support the use of CYP2C9, VKORC1 polymorphisms (rs9934438 or rs9923231) and clinical covariates to predict warfarin dose in both African- and European-Americans. A uniform set of common polymorphisms in CYP2C9 and VKORC1, and limited clinical covariates can be used to improve warfarin dose prediction for a racially diverse population.
Vasen, Hans F. A.; Blanco, Ignacio; Aktan-Collan, Katja; Gopie, Jessica P.; Alonso, Angel; Aretz, Stefan; Bernstein, Inge; Bertario, Lucio; Burn, John; Capella, Gabriel; Colas, Chrystelle; Engel, Christoph; Frayling, Ian M.; Genuardi, Maurizio; Heinimann, Karl; Hes, Frederik J.; Hodgson, Shirley V.; Karagiannis, John A.; Lalloo, Fiona; Lindblom, Annika; Mecklin, Jukka-Pekka; Moller, Pal; Myrhoj, Torben; Nagengast, Fokko M.; Parc, Yann; de Leon, Maurizio Ponz; Renkonen-Sinisalo, Laura; Sampson, Julian R.; Stormorken, Astrid; Sijmons, Rolf H.; Tejpar, Sabine; Thomas, Huw J. W.; Rahner, Nils; Wijnen, Juul T.; Jaervinen, Heikki Juhani; Moeslein, Gabriela; Jarvinen, H.J.; Moslein, G.
Lynch syndrome (LS) is characterised by the development of colorectal cancer, endometrial cancer and various other cancers, and is caused by a mutation in one of the mismatch repair genes: MLH1, MSH2, MSH6 or PMS2. In 2007, a group of European experts (the Mallorca group) published guidelines for
Background Influenza vaccination in infants and children with existing health complications is current practice in many countries, but healthy children are also susceptible to influenza, sometimes with complications. The under-recognised burden of disease in young children is greater than in elderly populations and the number of paediatric influenza cases reported does not reflect the actual frequency of influenza. Discussion Vaccination of healthy children is not widespread in Europe despite clear demonstration of the benefits of vaccination in reducing the large health and economic burden of influenza. Universal vaccination of infants and children also provides indirect protection in other high-risk groups in the community. This paper contains the Central European Vaccination Advisory Group (CEVAG) guidance statement on recommendations for the vaccination of infants and children against influenza. The aim of CEVAG is to encourage the efficient and safe use of vaccines to prevent and control infectious diseases. Summary CEVAG recommends the introduction of universal influenza vaccination for all children from the age of 6 months. Special attention is needed for children up to 60 months of age as they are at greatest risk. Individual countries should decide on how best to implement this recommendation based on their circumstances. PMID:20546586
Brüggemann, M; Schrauder, A; Raff, T
in treatment stratification. Therefore, there is an increasing need for standardization of methodologies and harmonization of terminology. For this purpose, a panel of representatives of all major European study groups on childhood and adult ALL and of international experts on PCR- and flow cytometry-based MRD...... implementation of MRD diagnostics into clinical trials. Finally, a common terminology for a standard description of MRD response and monitoring was established defining the terms 'complete MRD response', 'MRD persistence' and 'MRD reappearance'. The proposed MRD terminology may allow a refined and standardized...
Adjuvant therapy with pegylated interferon alfa-2b versus observation in resected stage III melanoma: a phase III randomized controlled trial of health-related quality of life and symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group.
Bottomley, A.; Coens, C.; Suciu, S.; Santinami, M.; Kruit, W.; Testori, A.; Marsden, J.; Punt, C.J.A.; Sales, F.; Gore, M.; MacKie, R.; Kusic, Z.; Dummer, R.; Patel, P.; Schadendorf, D.; Spatz, A.; Keilholz, U.; Eggermont, A.M.M.
PURPOSE: Interferon (IFN) -based adjuvant therapy in melanoma is associated with significant side effects, which necessitates evaluation of health-related quality of life (HRQOL). Our trial examined the HRQOL effects of adjuvant pegylated IFN-alpha-2b (PEG-IFN-alpha-2b) versus observation in
Hussein, Mohammad; Clementel, Enrico; Eaton, David J; Greer, Peter B; Haworth, Annette; Ishikura, Satoshi; Kry, Stephen F; Lehmann, Joerg; Lye, Jessica; Monti, Angelo F; Nakamura, Mitsuhiro; Hurkmans, Coen; Clark, Catharine H
Quality assurance (QA) for clinical trials is important. Lack of compliance can affect trial outcome. Clinical trial QA groups have different methods of dose distribution verification and analysis, all with the ultimate aim of ensuring trial compliance. The aim of this study was to gain a better understanding of different processes to inform future dosimetry audit reciprocity. Six clinical trial QA groups participated. Intensity modulated treatment plans were generated for three different cases. A range of 17 virtual 'measurements' were generated by introducing a variety of simulated perturbations (such as MLC position deviations, dose differences, gantry rotation errors, Gaussian noise) to three different treatment plan cases. Participants were blinded to the 'measured' data details. Each group analysed the datasets using their own gamma index (γ) technique and using standardised parameters for passing criteria, lower dose threshold, γ normalisation and global γ. For the same virtual 'measured' datasets, different results were observed using local techniques. For the standardised γ, differences in the percentage of points passing with γ clinical trial QA group's analysis. These variations may be due to different software implementations of γ. This virtual dosimetry audit has been an informative step in understanding differences in the verification of measured dose distributions between different clinical trial QA groups. This work lays the foundations for audit reciprocity between groups, particularly with more clinical trials being open to international recruitment. Copyright © 2017 Elsevier B.V. All rights reserved.
Creutzberg, C.L.; Kitchener, H.C.; Birrer, M.J.; Landoni, F.; Lu, K.H.; Powell, M.; Aghajanian, C.; Edmondson, R.; Goodfellow, P.J.; Quinn, M.; Salvesen, H.B.; Thomas, G.; Ottevanger, N.
OBJECTIVE: The second Gynecologic Cancer InterGroup (GCIG) Endometrial Cancer Clinical Trials Planning Meeting was held on December 1, 2012, and included international multidisciplinary representatives of the 24 member groups. The aims were to review recent advances in molecular pathology of
Walenta, K; Sinning, J M; Werner, C; Böhm, M
This article provides information and commentaries on trials which were presented at the Hotline and Clinical Trial Update Sessions during the Late Breaking Clinical Trial Sessions European Society of Cardiology Congress, held in Paris, France, from 27th to 31st August 2011. This article gives an overview on a number of novel clinical trials in the field of cardiovascular medicine, which were presented. The data have been presented by leading experts in the accordant field with relevant positions in the trials. Unpublished reports should be considered as preliminary data as the analysis may change in the final publications. The comprehensive summaries have been generated from the oral presentation and the webcasts of the European Society of Cardiology, similar as previously reported (Lenski et al. in Clin Res Cardiol Off J Ger Card Soc 99: 679-692, 2010) and should provide the readers with the most comprehensive information of relevant publications. The data were presented by leading experts in the field with relevant positions in the trials.
Skiada, A.; Pagano, L.; Groll, A.; Zimmerli, S.; Dupont, B.; Lagrou, K.; Lass-Florl, C.; Bouza, E.; Klimko, N.; Gaustad, P.; Richardson, M.; Hamal, P.; Akova, M.; Meis, J.F.G.M.; Rodriguez-Tudela, J.L.; Roilides, E.; Mitrousia-Ziouva, A.; Petrikkos, G.
Zygomycosis is an important emerging fungal infection, associated with high morbidity and mortality. The Working Group on Zygomycosis of the European Confederation of Medical Mycology (ECMM) prospectively collected cases of proven and probable zygomycosis in 13 European countries occurring between
Dahlborn, K; Bugnon, P; Nevalainen, T; Raspa, M; Verbost, P; Spangenberg, E
The primary aim of this report is to assist scientists in selecting more reliable/suitable identification (ID) methods for their studies. This is especially true for genetically altered (GA) animals where individual identification is strictly necessary to link samples, research design and genotype. The aim of this Federation of European Laboratory Animal Science Associations working group was to provide an update of the methods used to identify rodents in different situations and to assess their implications for animal welfare. ID procedures are an indispensable prerequisite for conducting good science but the degree of invasiveness differs between the different methods; therefore, one needs to make a good ethical evaluation of the method chosen. Based on the scientific literature the advantages and disadvantages of various methods have been presented comprehensively and this report is intended as a practical guide for researchers. New upcoming methods have been included next to the traditional techniques. Ideally, an ID method should provide reliable identification, be technically easy to apply and not inflict adverse effects on animals while taking into account the type of research. There is no gold standard method because each situation is unique; however, more studies are needed to better evaluate ID systems and the desirable introduction of new and modern approaches will need to be assessed by detailed scientific evaluation.
Rief, Winfried; Burton, Chris; Frostholm, Lisbeth; Henningsen, Peter; Kleinstäuber, Maria; Kop, Willem J; Löwe, Bernd; Martin, Alexandra; Malt, Ulrik; Rosmalen, Judith; Schröder, Andreas; Shedden-Mora, Meike; Toussaint, Anne; van der Feltz-Cornelis, Christina
The harmonization of core outcome domains in clinical trials facilitates comparison and pooling of data, and simplifies the preparation and review of research projects and comparison of risks and benefits of treatments. Therefore, we provide recommendations for the core outcome domains that should be considered in clinical trials on the efficacy and effectiveness of interventions for somatic symptom disorder, bodily distress disorder, and functional somatic syndromes. The European Network on Somatic Symptom Disorders group of more than 20 experts in the field met twice in Hamburg to discuss issues of assessment and intervention research in somatic symptom disorder, bodily distress disorder, and functional somatic syndromes. The consensus meetings identified core outcome domains that should be considered in clinical trials evaluating treatments for somatic symptom disorder and associated functional somatic syndromes. The following core domains should be considered when defining ascertainment methods in clinical trials: a) classification of somatic symptom disorder/bodily distress disorder, associated functional somatic syndromes, and comorbid mental disorders (using structured clinical interviews), duration of symptoms, medical morbidity, and prior treatments; b) location, intensity, and interference of somatic symptoms; c) associated psychobehavioral features and biological markers; d) illness consequences (quality of life, disability, health care utilization, health care costs; e) global improvement and treatment satisfaction; and f) unwanted negative effects. The proposed criteria are intended to improve synergies of clinical trials and to facilitate decision making when comparing different treatment approaches. These recommendations should not result in inflexible guidelines, but increase consistency across investigations in this field.
Duffy, Michael J
Several randomized controlled trials have shown that population-based screening using faecal occult blood testing (FOBT) can reduce mortality from colorectal neoplasia. Based on this evidence, a number of countries have introduced screening for colorectal cancer (CRC) and high-risk adenoma and many others are considering its introduction. The aim of this article is to critically review the current status of faecal markers as population-based screening tests for these neoplasia. Most of the available faecal tests involve the measurement of either occult blood or a panel of DNA markers. Occult blood may be measured using either the guaiac faecal occult blood test (gFOBT) or a faecal immunochemical test (iFOBT). Although iFOBT may require a greater initial investment, they have several advantages over gFOBT, including greater analytical sensitivity and specificity. Their use results in improved clinical performance and higher uptake rates. Importantly for population screening, some of the iFOBTs can be automated and provide an adjustable cutoff for faecal haemoglobin concentration. However, samples for iFOBT, may be less stable after collection than for gFOBT. For new centres undertaking FOBT for colorectal neoplasia, the European Group on Tumour Markers recommends use of a quantitative iFOBT with an adjustable cutoff point and high throughput analysis. All participants with positive FOBT results should be offered colonoscopy. The panel recommends further research into increasing the stability of iFOBT and the development of improved and affordable DNA and proteomic-based tests, which reduce current false negative rates, simplify sample transport and enable automated analysis.
Maria T Moreira
Full Text Available Young people tend to over-estimate peer group drinking levels. Personalised normative feedback (PNF aims to correct this misperception by providing information about personal drinking levels and patterns compared with norms in similar aged peer groups. PNF is intended to raise motivation for behaviour change and has been highlighted for alcohol misuse prevention by the British Government Behavioural Insight Team. The objective of the trial was to assess the effectiveness of PNF with college students for the prevention of alcohol misuse.Solomon three-group randomised controlled trial. 1751 students, from 22 British Universities, allocated to a PNF group, a normal control group, or a delayed measurement control group to allow assessment of any measurement effects. PNF was provided by email. Participants completed online questionnaires at baseline, 6- and 12-months (only 12-months for the delayed measurement controls. Drinking behaviour measures were (i alcohol disorders; (ii frequency; (iii typical quantity, (iv weekly consumption; (v alcohol-related problems; (vi perceived drinking norms; and (vii positive alcohol expectancies. Analyses focused on high-risk drinkers, as well as all students, because of research evidence for the prevention paradox in student drinkers.Follow-up rates were low, with only 50% and 40% responding at 6- and 12-months, respectively, though comparable to similar European studies. We found no evidence for any systematic attrition bias. Overall, statistical analyses with the high risk sub-sample, and for all students, showed no significant effects of the intervention, at either time-point, in a completed case analysis and a multiple imputation analysis.We found no evidence for the effectiveness of PNF for the prevention of alcohol misuse and alcohol-related problems in a UK student population.Controlled-Trials.com ISRCTN30784467.
Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne
Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This "preliminary" randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive…
Chen, Xi Jing; Hannibal, Niels; Gold, Christian
This study investigated the effects of group music therapy on improving anxiety, depression, and self-esteem in Chinese prisoners. Two hundred male prisoners were randomly assigned to music therapy (n = 100) or standard care (n = 100). The music therapy had 20 sessions of group therapy compared...... to standard care. Anxiety (STAI), depression (BDI) and self-esteem (TSBI, RSI) were measured by standardized scales at baseline, mid-program and post-program. Data were analyzed based on the intention to treat principle. Compared to standard care, anxiety and depression in the music therapy condition...... decreased significantly at mid-test and post-test; self-esteem improved significantly at mid-test (TSBI) and at post-test (TSBI, RSI). Improvements were greater in younger participants (STAI-Trait, RSI) and/or those with a lower level of education (STAI-State, STAI-Trait). Group music therapy seems...
Fischer, Melina; Wernike, Kerstin; Freuling, Conrad M.
Rabies is a lethal and notifiable zoonotic disease for which diagnostics have to meet the highest standards. In recent years, an evolution was especially seen in molecular diagnostics with a wide variety of different detection methods published. Therefore, a first international ring trial...... participants were asked to investigate a panel of defined lyssavirus RNAs, consisting of Rabies virus (RABV) and European bat lyssavirus 1 and 2 (EBLV-1 and -2) RNA samples, with systems available in their laboratory. The ring trial allowed the important conclusion that conventional RT-PCR assays were really...
McKeag, David; Lane, Carol; Lazarus, John H.; Baldeschi, Lelio; Boboridis, Kostas; Dickinson, A. Jane; Hullo, A. Iain; Kahaly, George; Krassas, Gerry; Marcocci, Claudio; Marinò, Michele; Mourits, Maarten P.; Nardi, Marco; Neoh, Christopher; Orgiazzi, Jacques; Perros, Petros; Pinchera, Aldo; Pitz, Susanne; Prummel, Mark F.; Sartini, Maria S.; Wiersinga, Wilmar M.
BACKGROUND: This study was performed to determine clinical features of dysthyroid optic neuropathy (DON) across Europe. METHODS: Forty seven patients with DON presented to seven European centres during one year. Local protocols for thyroid status, ophthalmic examination and further investigation
Summaries are presented of talks given at the eleventh conference of the European group for atomic spectroscopy. Topics covered include: lifetimes; collisions; line shape; hyperfine structure; isotope shifts; saturation spectroscopy; Hanle effect; Rydberg levels; quantum beats; helium and helium-like atoms; metrology; and molecules. (GHT)
Harding, Jessica F.; Sibley, Chris G.; Robertson, Andrew
New Zealand (NZ) Europeans show a unique implicit bicultural effect, with research using the Implicit Association Test consistently showing that they associate Maori (the Indigenous peoples) and their own (dominant/advantaged majority) group as equally representative of the nation. We replicated and extended this NZ = bicultural effect in a small…
Duarte, Rosa; Escario, José-Julián; Sanagustín, María-Victoria
The attitudes of young people arise from an intense interaction with their social groups of reference, and in this work we examine the extent to which this background conditions the individual environmental attitudes of the young. Using data provided by the PISA 2006 survey for the European Union, we test for the influence of the family, the…
Guandalini, S; Pensabene, L; Zikri, M A; Dias, J A; Casali, L G; Hoekstra, H; Kolacek, S; Massar, K; Micetic-Turk, D; Papadopoulou, A; de Sousa, J S; Sandhu, B; Szajewska, H; Weizman, Z
The probiotic Lactobacillus GG is effective in promoting a more rapid recovery of acute, watery diarrhea in children with rotavirus enteritis. Very limited information is available, however, on the potential role of such agents in non-rotaviral diarrheal episodes. Furthermore, no evidence is available concerning the efficacy of Lactobacillus GG administered in the oral rehydration solution during oral rehydration therapy. A multicenter trial was conducted to evaluate the efficacy of Lactobacillus GG administered in the oral rehydration solution to patients with acute-onset diarrhea of all causes. Children 1 month to 3 years of age with acute-onset diarrhea were enrolled in a double-blind, placebo-controlled investigation. Patients were randomly allocated to group A, receiving oral rehydration solution plus placebo, or group B, receiving the same preparation but with a live preparation of Lactobacillus GG (at least 10(10) CFU/250 ml). After rehydration in the first 4 to 6 hours, patients were offered their usual feedings plus free access to the same solution until diarrhea stopped. One hundred forty children were enrolled in group A, and 147 in group B. There were no differences at admission between the groups in age, sex, previous types of feeding, previous duration of diarrhea, use of antibiotics, weight, height, weight-height percentile, prevalence of fever, overall status, degree of dehydration, and percentage of in- versus outpatients. Duration of diarrhea after enrollment was 71.9 +/- 35.8 hours in group A versus 58.3 +/- 27.6 hours in group B (mean +/- SD; P = 0.03). In rotavirus-positive children, diarrhea lasted 76.6 +/- 41.6 hours in group A versus 56.2 +/- 16.9 hours in groups B (P children with acute diarrhea is safe and results in shorter duration of diarrhea, less chance of a protracted course, and faster discharge from the hospital.
Modigliani, E; Vasen, H M; Raue, K; Dralle, H; Frilling, A; Gheri, R G; Brandi, M L; Limbert, E; Niederle, B; Forgas, L
Pheochromocytoma (pheo) is the second component of the multiple endocrine neoplasia type 2 (MEN 2) syndrome. Clinical expression is sometimes poor, and chronology between medullary thyroid carcinoma (MTC) and pheo is not well evaluated. Therefore, a retrospective study was done in eight European countries in order to precise the main characteristics of pheo in MEN 2. Data from 300 MEN 2 patients with pheo (274 MEN 2 A and 26 MEN 2 B) were obtained from cases registered by the EuroMen study group, and collected by a medical standardized questionnaire. These cases occurred between 1969 and 1992. Mean age at diagnosis of pheo was 39.5 years (range 14-68 years) in MEN 2A and 32.4 years (range 15-41 years) in MEN 2B patients. Pheo occurred first in 25.1% of the cases (2-15 years before diagnosis of MTC) and after MTC in 40.2% (2-11 years). In other cases (34.7%), MTC and pheo were diagnosed at the same time. Involvement was bilateral in 67.8% of cases. Malignancy was only 4%. Thirty-nine deaths occurred in these 300 patients, 64.1% were linked in pheo, 23.1% to MTC and 12.8% to other causes. Surgery was unilateral in 39.7% of the cases and bilateral adrenalectomy was the first procedure in 48.4%. A bilateral adrenalectomy in two steps had to be done in 11.9% of cases. In conclusion, these results justify systematic and prolonged biochemical screening of pheo during follow-up of MTC and address some questions about the best mode of surgery.
Taubman, M; Brierley, S; Wishner, J; Baker, D; McEachin, J; Leaf, R B
Group behavioral classroom instruction for children with developmental disabilities has been shown to allow for increased efficiency, approximation to naturalistic arrangements, and enhanced opportunity for interaction, social teaching and observational learning. This study examines the effectiveness of a group instructional extension of one to one discrete trial teaching, which involves the overlapping of trials between students along with the use of sequential and choral group teaching. A multiple baseline design across tasks was employed to examine the effectiveness of the group instructional approach in promoting acquisition of educational skills among preschoolers with autism and other developmental disabilities. A time sample interval assessment of components of the group instruction was also conducted. The approach was demonstrated to consistently increase correct responding across the task areas. Results are discussed in terms of the advantages of the group instructional approach as an adjunct to one to one discrete trial instruction.
Costa, Diogo; Matanov, Aleksandra; Canavan, Reamonn; Gabor, Edina; Greacen, Tim; Vondráčková, Petra; Kluge, Ulrike; Nicaise, Pablo; Moskalewicz, Jacek; Díaz–Olalla, José Manuel; Straßmayr, Christa; Kikkert, Martijn; Soares, Joaquim JF; Gaddini, Andrea; Barros, Henrique
Background: Different service characteristics are known to influence mental health care delivery. Much less is known about the impact of contextual factors, such as the socioeconomic circumstances, on the provision of care to socially marginalized groups. The objectives of this work were to assess the organisational characteristics of services providing mental health care for marginalized groups in 14 European capital cities and to explore the associations between organisational quality, serv...
Full Text Available The central purpose of the paper is to explain why some officials involved in Council working groups have a more positive disposition towards European integration than others. The paper is inspired by the fact that many studies on European integration deal only occasionally with the attitudes and the ideas of the men and the women involved in daily negotiations. Consequently most studies employ member-states or European institutions (e.g. the Council, the Commission and the European Parliament as central units of analysis and the description of European policy-making is therefore often based on a limited number of observations (small-N-analysis. In this paper we propose to desaggregate the Council in multiple observations, the officials involved in day-to-day proceedings. In doing so we hope to obtain a more profound understanding of the Council negotiator's attitudes. This systematic empirical analysis leads to the conclusion that the interaction between domestic and transgovernemental experiences explains a signification proportion of the variance along the supranational-intergovernmental continuum.
Luo, Jake; Eldredge, Christina; Cho, Chi C; Cisler, Ron A
Understanding adverse event patterns in clinical studies across populations is important for patient safety and protection in clinical trials as well as for developing appropriate drug therapies, procedures, and treatment plans. The objective of our study was to conduct a data-driven population-based analysis to estimate the incidence, diversity, and association patterns of adverse events by age of the clinical trials patients and participants. Two aspects of adverse event patterns were measured: (1) the adverse event incidence rate in each of the patient age groups and (2) the diversity of adverse events defined as distinct types of adverse events categorized by organ system. Statistical analysis was done on the summarized clinical trial data. The incident rate and diversity level in each of the age groups were compared with the lowest group (reference group) using t tests. Cohort data was obtained from ClinicalTrials.gov, and 186,339 clinical studies were analyzed; data were extracted from the 17,853 clinical trials that reported clinical outcomes. The total number of clinical trial participants was 6,808,619, and total number of participants affected by adverse events in these trials was 1,840,432. The trial participants were divided into eight different age groups to support cross-age group comparison. In general, children and older patients are more susceptible to adverse events in clinical trial studies. Using the lowest incidence age group as the reference group (20-29 years), the incidence rate of the 0-9 years-old group was 31.41%, approximately 1.51 times higher (P=.04) than the young adult group (20-29 years) at 20.76%. The second-highest group is the 50-59 years-old group with an incidence rate of 30.09%, significantly higher (Pgroup. The adverse event diversity also increased with increase in patient age. Clinical studies that recruited older patients (older than 40 years) were more likely to observe a diverse range of adverse events (Page group (older
Jia, Zhenyu; Lilly, Michael B; Koziol, James A; Chen, Xin; Xia, Xiao-Qin; Wang, Yipeng; Skarecky, Douglas; Sutton, Manuel; Sawyers, Anne; Ruckle, Herbert; Carpenter, Philip M; Wang-Rodriguez, Jessica; Jiang, Jun; Deng, Mingsen; Pan, Cong; Zhu, Jian-Guo; McLaren, Christine E; Gurley, Michael J; Lee, Chung; McClelland, Michael; Ahlering, Thomas; Kattan, Michael W; Mercola, Dan
It is difficult to construct a control group for trials of adjuvant therapy (Rx) of prostate cancer after radical prostatectomy (RP) due to ethical issues and patient acceptance. We utilized 8 curve-fitting models to estimate the time to 60%, 65%, … 95% chance of progression free survival (PFS) based on the data derived from Kattan post-RP nomogram. The 8 models were systematically applied to a training set of 153 post-RP cases without adjuvant Rx to develop 8 subsets of cases (reference case sets) whose observed PFS times were most accurately predicted by each model. To prepare a virtual control group for a single-arm adjuvant Rx trial, we first select the optimal model for the trial cases based on the minimum weighted Euclidean distance between the trial case set and the reference case set in terms of clinical features, and then compare the virtual PFS times calculated by the optimum model with the observed PFSs of the trial cases by the logrank test. The method was validated using an independent dataset of 155 post-RP patients without adjuvant Rx. We then applied the method to patients on a Phase II trial of adjuvant chemo-hormonal Rx post RP, which indicated that the adjuvant Rx is highly effective in prolonging PFS after RP in patients at high risk for prostate cancer recurrence. The method can accurately generate control groups for single-arm, post-RP adjuvant Rx trials for prostate cancer, facilitating development of new therapeutic strategies.
Schroeder, R W; Buddin, W H; Hargrave, D D; VonDran, E J; Campbell, E B; Brockman, C J; Heinrichs, R J; Baade, L E
The Test of Memory Malingering is one of the most popular and heavily researched validity tests available for use in neuropsychological evaluations. Recent research has suggested, however, that the original indices and cutoffs may require modifications to increase sensitivity rates. Some of these modifications lack cross-validation and no study has examined all indices in a single sample. This study compares Trial 1, Trial 2, the Retention Trial, and the newly created Albany Consistency Index in a criterion group forensic neuropsychological sample. Findings lend support for the newly created indices and cutoff scores. Implications and cautionary statements are provided and discussed.
Creutzberg, Carien L; Kitchener, Henry C; Birrer, Michael J; Landoni, Fabio; Lu, Karen H; Powell, Melanie; Aghajanian, Carol; Edmondson, Richard; Goodfellow, Paul J; Quinn, Michael; Salvesen, Helga B; Thomas, Gillian
The second Gynecologic Cancer InterGroup (GCIG) Endometrial Cancer Clinical Trials Planning Meeting was held on December 1, 2012, and included international multidisciplinary representatives of the 24 member groups. The aims were to review recent advances in molecular pathology of endometrial cancer, focusing on molecular-based therapy, and to identify key hypotheses and issues to be addressed through international collaborative clinical trials. Reviews and summaries of current knowledge were presented followed by parallel working group sessions for surgery, adjuvant and systemic therapy, and translational research. Plenary discussions were held to integrate translational and clinical issues, and a final discussion session to agree on key trial concepts. Proposals to take forward on the following trials were agreed: (1) lymphadenectomy to direct adjuvant treatment in women with high-risk endometrial cancer, including a sentinel node substudy; (2) conservative therapy for low-risk endometrial cancers in morbidly obese women with high surgical risks and for fertility-sparing treatment in premenopausal patients; (3) adjuvant therapy for women with early-stage carcinosarcoma. A proposal was made that a GCIG Early Phase Consortium be developed to serve as an international platform for rapid assessment of biomarkers.
Lenski, Matthias; Mahfoud, Felix; Werner, Christian; Bauer, Axel; Böhm, Michael
This article gives an overview on several novel clinical trials in the field of cardiovascular (CV) medicine which were presented during the hotline sessions and clinical trial updates at the European Society of Cardiology Congress, held in Stockholm, Sweden, from 28th August to 1st September 2010. The data have been presented by leading experts in the accordant field with relevant positions in the trials. Unpublished reports should be considered as preliminary data as the analysis may change in the final publications. The summaries presented in the manuscript were generated from the oral presentations and should provide the readers with the most comprehensive information on diagnostic and therapeutic development in CV medicine similar as previously reported Schirmer SH et al.
Berkhout, Joost; Carroll, Brendan; Braun, Caelesta; Chalmers, Adam; De Strooper, Tine; Lowery, David; Otjes, Simon; Rasmussen, Anne
The number of interest organizations (density) varies across policy domains, political issues and economic sectors. This shapes the nature and outcomes of interest representation. In this contribution, we explain the density of interest organizations per economic sector in the European Union on the
Berkhout, Joost; Carroll, Brendan J.; Braun, Caelesta; Chalmers, Adam W.; Destrooper, Tine; Lowery, David; Otjes, Simon; Rasmussen, Anne
The number of interest organizations (density) varies across policy domains, political issues and economic sectors. This shapes the nature and outcomes of interest representation. In this contribution, we explain the density of interest organizations per economic sector in the European Union on the
Riddell, Sheila; Weedon, Elisabet
The central questions addressed in this paper are the following: (1) In the context of the (European Union) EU's goal of severing the link between social class background and higher education participation, what progress has been made in widening access over the past two decades? (2) Has the Open Method of Coordination (OMC) helped EU countries to…
Kelly, L.; Brouwer, A.; Wilson, A.; Gale, P.; Snary, E.; Ross, D.; Vos, de C.J.
In recent years, several animal disease epidemics have occurred within the European Union (EU). At the 4th Annual Meeting of the EPIZONE network (7-10 June 2010, St. Malo, France), an interactive session was run to elicit the opinions of delegates on a pre-defined list of epidemic threats to the EU.
Duncan, David F.
Examined self-reported reasons for discontinuing marijuana use among 61 former marijuana using students at central European sports training facility. Most common reasons given for discontinuing marijuana use were dislike of effects, athletic training regimen, health reasons, and mental/emotional problems. (Author/NB)
Marchesi, Emanuela; Cagnazzo, Celeste; Quattrini, Irene; Leopardi, Martina Piccinni; Villa, Chiara; Grignani, Giovanni; D'Ambrosio, Lorenzo; Stacchiotti, Silvia; Casali, Paolo Giovanni; Picci, Piero
The Italian Sarcoma Group (ISG) is a nonprofit group of professionals established in 1997 aimed to improve the quality of care and promote the independent research in sarcomas. The increased regulatory requirements, the chance to increase the number of trials with other cooperative groups and an interest from pharmaceutical companies in supporting independent research, generated the need of an internal service for research management. In 2010, ISG implemented in its organization a Clinical Trial Unit (CTU). The CTU was appointed to fully manage Clinical Trial Operations, to guarantee regulation compliance and provide a central support to the investigators, fostering a collaboration both at national and international level. In 2016 ISG promoted 25 studies in about 120 centers, with a fivefold increase in the last 5 years: 68% were interventional and 32% observational. Nine of the 17 interventional studies (52%) were supported by pharmaceutical companies, while 4 (24%) were funded by European Commission within specific projects on sarcomas and 4 (24%) were supported by the ISG itself. The contribution of ISG researchers to the international community was striking from the earliest years of the ISG creation. The challenges of the regulatory clinical research scenario, which imposes solid and hard-fast methodology with deep knowledge and expertise, highlighted the need to identify qualified and dedicated experts able to run and follow the multifaceted aspects of trials. Our analysis demonstrated how this model has led to a growth in competitiveness of the group. The collaboration between clinicians and CTU made possible to support the research with high scientific and ethical standards and to increase the number of trials, sites and overall enrolled patients. The reduced time for approvals, the continuous support to sites, the increased speed in data collection and analysis make the ISG research attractive for pharmaceutical industries, despite the problems that have
Bjornsson, Andri S; Bidwell, L Cinnamon; Brosse, Alisha L; Carey, Gregory; Hauser, Monika; Mackiewicz Seghete, Kristen L; Schulz-Heik, R Jay; Weatherley, Donald; Erwin, Brigette A; Craighead, W Edward
In this randomized controlled trial, cognitive-behavioral group therapy (CBGT) for social anxiety disorder (SAD) was compared to group psychotherapy (GPT), a credible, structurally equivalent control condition that included only nonspecific factors of group treatment (such as group dynamics). Participants were 45 college students at the University of Colorado with a primary diagnosis of SAD. Each treatment condition comprised eight group sessions lasting 2 hr each. Independent assessors (blind to treatment assignment) assessed participants at baseline and posttreatment with the Clinical Global Impression Scale (CGI) and the Liebowitz Social Anxiety Scale (LSAS). Both treatments were found to be equally credible. There were five noncompleters in the CBGT condition (21.7%) and only one in the GPT condition (4.3%). There were no statistically significant differences posttreatment (controlling for pretreatment scores) between the two treatment conditions, and both treatments were found to be efficacious. Effect sizes for CBGT were similar to earlier studies, and adherence ratings revealed excellent adherence. Treatment of SAD appears to be moving toward individual CBT, partly because of high attrition rates and underutilization of group dynamics in group CBT. However, group therapy has unique therapeutic ingredients, and it may be too early to give up on group treatment altogether. Discussion of these findings included future directions with this treatment modality, especially whether these two types of group treatment could be combined and whether such combination might serve to decrease attrition, enhance efficacy, and facilitate dissemination. © 2011 Wiley Periodicals, Inc.
Feys, Frederik; Bekkering, Geertruida E; Singh, Kavita; Devroey, Dirk
Studies suggest that expectations powerfully shape clinical outcomes. For subjective outcomes in adequately blinded trials, health improvements are substantial and largely explained by non-specific factors.The objective of this study was to investigate if unblinding in randomized controlled trials (RCTs) is associated with enhanced placebo effects for intervention groups and nocebo effects for placebo groups. For these effects, a secondary objective was to explore potential moderating factors. We included RCTs that investigated the efficacy of phosphodiesterase-5 (PDE-5) inhibitors for male erectile dysfunction by comparing one PDE-5 inhibitor to placebo. In addition, to be included studies must have reported scores for change from baseline, or baseline and final International Index of Erectile Functioning-Erectile Functioning domain score (IIEF-EF), and be published in either English, French, Dutch, or German.We searched for both published and unpublished relevant trials using PUBMED, EMBASE, the Cochrane Central Register of Controlled Trials, a clinical trials register (clinicaltrials.gov) and the Food and Drug Administration clinical reviews through March 2012.We evaluated the blinding status of trials with the Cochrane Risk of Bias Tool, using the domains of allocation sequence concealment, blinding of participants, healthcare providers and outcome assessors. Across these four domains, studies that scored low risk of bias were judged to be adequately blinded and studies that scored unclear or high risk of bias were judged to be inadequately blinded. We included 110 studies (205 journal publications and 2 unpublished sources) that involved 23,877 participants; 93 (85%), 51 (46%), 93 (85%) and 93 (85%) studies were assessed with an unclear risk of bias for allocation concealment, blinding of participant, blinding of caregiver and blinding of outcome assessor, respectively. None of the studies reported testing of blinding.None of the 205 journal publications
Steins Bisschop, Charlotte N; Courneya, Kerry S; Velthuis, Miranda J; Monninkhof, Evelyn M; Jones, Lee W; Friedenreich, Christine; van der Wall, Elsken; Peeters, Petra H M; May, Anne M
Important considerations for exercise trials in cancer patients are contamination and differential drop-out among the control group members that might jeopardize the internal validity. This systematic review provides an overview of different control groups design characteristics of exercise-oncology trials and explores the association with contamination and drop-out rates. Randomized controlled exercise-oncology trials from two Cochrane reviews were included. Additionally, a computer-aided search using Medline (Pubmed), Embase and CINAHL was conducted after completion date of the Cochrane reviews. Eligible studies were classified according to three control group design characteristics: the exercise instruction given to controls before start of the study (exercise allowed or not); and the intervention the control group was offered during (any (e.g., education sessions or telephone contacts) or none) or after (any (e.g., cross-over or exercise instruction) or none) the intervention period. Contamination (yes or no) and excess drop-out rates (i.e., drop-out rate of the control group minus the drop-out rate exercise group) were described according to the three design characteristics of the control group and according to the combinations of these three characteristics; so we additionally made subgroups based on combinations of type and timing of instructions received. 40 exercise-oncology trials were included based on pre-specified eligibility criteria. The lowest contamination (7.1% of studies) and low drop-out rates (excess drop-out rate -4.7±9.2) were found in control groups offered an intervention after the intervention period. When control groups were offered an intervention both during and after the intervention period, contamination (0%) and excess drop-out rates (-10.0±12.8%) were even lower. Control groups receiving an intervention during and after the study intervention period have lower contamination and drop-out rates. The present findings can be
van der Linden, Meta; Hooghe, Marc; de Vroome, Thomas; Van Laar, Colette
The aim of this study is twofold. First, we expand on the literature by testing whether generalized trust is negatively related to anti-immigrant sentiments in Europe. Second, we examine to what extent the relation between generalized trust and anti-immigrant sentiments is dependent upon cross-group friendships. We apply multilevel linear regression modeling to representative survey data enriched with levels of ethnic diversity covering 21 European countries. Results show that both generalize...
Weedon, Elisabet; Riddell, Sheila
The central questions addressed in this paper are the following: (1) In the context of the (European Union) EU’s goal of severing the link between social class background and higher education participation, what progress has been made in widening access over the past two decades? (2) Has the Open Method of Coordination (OMC) helped EU countries to harmonize their policy and practice in relation to widening access to higher education? (3) What patterns of social stratification are evident in t...
Bergeaud-Blackler, Florence; Zivotofsky, Ari Z.; Miele, Mara
International audience; There is a very small, yet important minority within the community of European Union kosher consumers. There is a great deal of research regarding objective aspects of the kosher religious as well as civil laws and their implementation, but comparatively little research about the subjective attitudes, opinions, and concerns of those who actually purchase and consume kosher food. Such information can be important for a variety of interested parties including suppliers, ...
Recio-Mayoral, A.; Kaski, J. -C.; McMurray, J. J. V.; Horowitz, J.; van Veldhuisen, D. J.; Remme, W. J.
The Clinical Trials described in this article were presented at the Hotline and Clinical Trial Update Sessions of the European Society of Cardiology Congress held in September 2007 in Vienna, Austria. The sessions chosen for this article represent the scope of interest of Cardiovascular Drugs and
Tuminello, Elizabeth R.; Davidson, Denise
This study examined whether 3- to 7-year-old African American and European American children's assessment of emotion in face-only, face + body, and body-only photographic stimuli was affected by in-group emotion recognition effects and racial or gender stereotyping of emotion. Evidence for racial in-group effects was found, with European American…
Herting, E.; Gefeller, O.; Land, M.; Van Sonderen, L.; Harms, K.; Robertson, B.
Connatal pneumonia caused by group B streptococcal (GBS) infection may be associated with surfactant dysfunction. We investigated the effects of surfactant treatment in term and preterm neonates with GBS infection and respiratory failure, in comparison with corresponding data from a control
Bible, Keith C; Cote, Gilbert J; Demeure, Michael J; Elisei, Rossella; Jhiang, Sissy; Ringel, Matthew D
Patients with progressive thyroid cancer in distant metastatic sites represent a population with a need for new therapeutic options. Aspiring to improve the treatment of such patients, the objective of this position statement from the International Thyroid Oncology Group (ITOG) is to clarify the importance of incorporating high-quality correlative studies into clinical trials. ITOG was formed to develop and support high-quality multicenter and multidisciplinary clinical trials for patients with aggressive forms of thyroid cancer. The Correlative Sciences Committee of the ITOG focuses on the quality and types of correlative studies included in ITOG-associated clinical trials. This document represents expert consensus from ITOG regarding this issue based on extensive collective experience in clinical and translational trials informed by basic science. The Correlative Studies Committee identified an international writing group representative of diverse specialties, including basic sciences. Drafts were reviewed by all members of the writing group, the larger committee, and the ITOG board. After consideration of all comments by the writing group and modification of the document, the final document was then approved by the authors and the ITOG board. High-quality correlative studies, which include variety in the types of correlates, should be intrinsic to the design of thyroid cancer clinical trials to offer the best opportunity for each study to advance treatment for patients with advanced and progressive thyroid cancer.
Haugen, Maureen; Kelly, Katherine Patterson; Leonard, Marcia; Mills, Denise; Sung, Lillian; Mowbray, Catriona; Landier, Wendy
The progress made over the past 50 years in disease-directed clinical trials has significantly increased cure rates for children and adolescents with cancer. The Children's Oncology Group (COG) is now conducting more studies that emphasize improving quality of life for young people with cancer. These types of clinical trials are classified as cancer control (CCL) studies by the National Cancer Institute and require different resources and approaches to facilitate adequate accrual and implementation at COG institutions. Several COG institutions that had previously experienced problems with low accruals to CCL trials have successfully implemented local nursing leadership for these types of studies. Successful models of nurses as institutional leaders and "champions" of CCL trials are described. © 2015 by Association of Pediatric Hematology/Oncology Nurses.
Mosora Liviu - Cosmin
Full Text Available Romania has the highest share of European Union rural areas (44.9% in 2009, which generates and maintains a long series of regional disparities. Because of these disparities, the economy faces a number of elements that undermine the quality of human and social capital and reduces the potential for growth: precarious social and economic infrastructure, reduced access to markets and thus to goods, a low level of both economic cohesion and living standards, and a difficult access to education and training (leading to the underutilization of labor in rural areas, while major shortages in the labor market and increased migration phenomenon manifests.\\r\
Mattucci, Federica; Oliveira, Rita; Lyons, Leslie A; Alves, Paulo C; Randi, Ettore
Extant populations of the European wildcat are fragmented across the continent, the likely consequence of recent extirpations due to habitat loss and over-hunting. However, their underlying phylogeographic history has never been reconstructed. For testing the hypothesis that the European wildcat survived the Ice Age fragmented in Mediterranean refuges, we assayed the genetic variation at 31 microsatellites in 668 presumptive European wildcats sampled in 15 European countries. Moreover, to evaluate the extent of subspecies/population divergence and identify eventual wild × domestic cat hybrids, we genotyped 26 African wildcats from Sardinia and North Africa and 294 random-bred domestic cats. Results of multivariate analyses and Bayesian clustering confirmed that the European wild and the domestic cats (plus the African wildcats) belong to two well-differentiated clusters (average Ф ST = 0.159, r st = 0.392, P > 0.001; Analysis of molecular variance [AMOVA]). We identified from c. 5% to 10% cryptic hybrids in southern and central European populations. In contrast, wild-living cats in Hungary and Scotland showed deep signatures of genetic admixture and introgression with domestic cats. The European wildcats are subdivided into five main genetic clusters (average Ф ST = 0.103, r st = 0.143, P > 0.001; AMOVA) corresponding to five biogeographic groups, respectively, distributed in the Iberian Peninsula, central Europe, central Germany, Italian Peninsula and the island of Sicily, and in north-eastern Italy and northern Balkan regions (Dinaric Alps). Approximate Bayesian Computation simulations supported late Pleistocene-early Holocene population splittings (from c. 60 k to 10 k years ago), contemporary to the last Ice Age climatic changes. These results provide evidences for wildcat Mediterranean refuges in southwestern Europe, but the evolution history of eastern wildcat populations remains to be clarified. Historical genetic subdivisions suggest
Hwang, Thomas J; Sokolov, Elisaveta; Franklin, Jessica M; Kesselheim, Aaron S
To evaluate safety alerts and recalls, publication of key trial outcomes, and subsequent US approval of high profile medical devices introduced in the European Union. Cohort study. Novel cardiovascular, orthopedic, and neurologic devices approved in the EU through Conformité Européenne marking between 2005 and 2010. Public and commercial databases searched up to January 2016 for press releases and announcements of approvals; public Food and Drug Administration and European regulatory authority databases for US approvals and safety alerts and recalls; and Medline, Embase, and Web of Science for peer reviewed publications. We categorized the novelty of the devices in the study sample as a "major innovation" or an "other change," and extracted descriptive data about the devices and information on any safety alerts and withdrawals. Linear regression models examined factors associated with differential EU and US approvals. Cox proportional hazards regression models were used to evaluate factors associated with safety alerts and recalls and the publication of trial outcomes for devices categorized as major innovations. Models controlled for time, therapeutic category, regulatory pathway, size of sponsoring company, and indicator variables for devices approved first in the EU and devices approved only in the EU. 67% (206/309) of devices identified were approved in both the US and the EU, of which 63% (129/206) were approved first in the EU. The unadjusted rate of safety alerts and recalls for devices approved first in the EU was 27% (62/232) compared with 14% (11/77) for devices approved first in the US. The adjusted hazard ratio for safety alerts and recalls was 2.9 (95% confidence interval 1.4 to 6.2) for devices approved first in the EU. The results of pivotal trials were published for 49% (37/75) of devices categorized as major innovations, with an overall publication rate of 37% five years after approval. Devices approved first in the EU are
Full Text Available It is difficult to construct a control group for trials of adjuvant therapy (Rx of prostate cancer after radical prostatectomy (RP due to ethical issues and patient acceptance. We utilized 8 curve-fitting models to estimate the time to 60%, 65%, … 95% chance of progression free survival (PFS based on the data derived from Kattan post-RP nomogram. The 8 models were systematically applied to a training set of 153 post-RP cases without adjuvant Rx to develop 8 subsets of cases (reference case sets whose observed PFS times were most accurately predicted by each model. To prepare a virtual control group for a single-arm adjuvant Rx trial, we first select the optimal model for the trial cases based on the minimum weighted Euclidean distance between the trial case set and the reference case set in terms of clinical features, and then compare the virtual PFS times calculated by the optimum model with the observed PFSs of the trial cases by the logrank test. The method was validated using an independent dataset of 155 post-RP patients without adjuvant Rx. We then applied the method to patients on a Phase II trial of adjuvant chemo-hormonal Rx post RP, which indicated that the adjuvant Rx is highly effective in prolonging PFS after RP in patients at high risk for prostate cancer recurrence. The method can accurately generate control groups for single-arm, post-RP adjuvant Rx trials for prostate cancer, facilitating development of new therapeutic strategies.
Bothamley, G.H.; Ditiu, L.; Migliori, G.B.
of isoniazid for treatment of LTBI, with an estimated median (range) uptake of 55% (5-92.5%). Symptoms and sputum examination could be used more widely when screening for active tuberculosis. Treatment of latent tuberculosis infection might be better focused by targeted use of interferon-gamma release assays...
Full Text Available In the early 1990s, and especially after the accession to the European Union, southern European countries were faced with an increased influx of immigration, particularly by third country citizens. The majority of migration flows refers to illegal migration. In this paper, the integration of new immigrant groups in the labour market has been analysed by using the theory of the segmented labour market. A high degree of labour market segmentation and irregularities in the analyzed countries is particularly present in the construction, agricultural and service sectors (households, hotels and catering. Illegal recruitment is an important attractive factor for illegal migrants, and encourages the development of illegal migration. Frequent implementation of control programmes solves the problem of illegal migrants only partially while, at the same time, an increasing number of new immigrants is being “attracted”. Due to special features of more recent migration flows in southern European countries, it is possible to apply the “South European immigration model” by King and Ribas-Mateos, portraying these flows triangularly. In this model the mass influx of immigration is connected to a high level of irregularities in the economic sector and a weak welfare state. The uneven economic development of sending and receiving countries, as well as the perception of new immigrants (third country citizens exclusively through the prism of homo economicus, does not inspire too much optimism that their position in the labour market and in society will significantly improve in the foreseeable future. On behalf of more equitable treatment of new immigrant groups, their greater recognition should be demanded from receiving countries’ governments as well as the regulation of their position by introducing new and different norms and standards, based in the first place on universal human rights.
Brensilver, Matthew; Heinzerling, Keith G; Swanson, Aimee-Noelle; Shoptaw, Steven J
Treatment responses of placebo groups in addiction medicine trials have important implications for research methodology and clinical practice, however studies examining placebo group responses in addiction medicine are scarce. Extant data suggest the importance of early treatment responsiveness for long-term outcomes. Among methamphetamine-(MA) dependent individuals randomized to placebo pill plus behavioral support conditions in pharmacotherapy development trials, we hypothesized that immediate abstinence would be a necessary but insufficient predictor for end-of-trial (EOT) abstinence. The study is a secondary analysis of participants (n = 184; 36% female) in the placebo condition of three randomized, placebo-controlled methamphetamine dependence pharmacotherapy trials. Receiver operating characteristic (ROC) curve analyses assessed the predictive power of initial abstinence, assessed by thrice weekly urine samples, for EOT abstinence. Sixty percent of individuals with complete abstinence in the first two weeks of treatment were abstinent at EOT, while 18% of people who failed to meet this standard were abstinent at EOT. Early response was related to retention at EOT and 12-month follow-up. Findings suggest that the inability to achieve at least three MA negative screenings in the first two weeks is associated with greater than 90% likelihood of treatment failure. A third week of screening added minimally to the prediction of EOT outcomes. The prediction of treatment failure was more precise than the prediction of treatment success. The absence of a clinical response in the first two weeks of treatment among participants in the placebo group signals high risk of treatment failure. The majority of information regarding response in the placebo group from a 12-week trial is obtained early in the trial.
Anderson, Kelly K; Flora, Nina; Ferrari, Manuela; Tuck, Andrew; Archie, Suzanne; Kidd, Sean; Tang, Taryn; Kirmayer, Laurence J; McKenzie, Kwame
Objective: To compare the pathways to care and duration of untreated psychosis (DUP) for people of Black-African, Black-Caribbean, or White-European origin with first-episode psychosis (FEP). Methods: We recruited a sample of 171 patients with FEP of Black-African, Black-Caribbean, and White-European origin from hospital- and community-based early intervention services (EIS) in the cities of Toronto and Hamilton. We compared the 3 groups on DUP and key indicators of the pathway to care. Results: We observed differences in pathways to care across the 3 groups. Black-Caribbean participants had an increased odds of referral from an inpatient unit to EIS (OR 3.33; 95% CI 1.46 to 7.60) and a decreased odds of general practitioner involvement on the pathway to care (OR 0.17; 95% CI 0.07 to 0.46), as well as fewer total contacts (exp[β] 0.77; 95% CI 0.60 to 0.99) when compared with White-European participants. Black-African participants had an increased odds of contact with the emergency department at first contact (OR 3.78; 95% CI 1.31 to 10.92). The differences in the DUP between groups were not statistically significant. Conclusions: Our findings suggest that there are significant differences in the pathways to EIS for psychosis for people of African and Caribbean origin in our Canadian context. It is essential to gain a comprehensive understanding of the pathways that different population groups take to mental health services, and the reasons behind observed differences, to inform the development of equitable services, targeting patients in the critical early stages of psychotic disorder. PMID:26174526
Kevin M Waters
Full Text Available It has been recently hypothesized that many of the signals detected in genome-wide association studies (GWAS to T2D and other diseases, despite being observed to common variants, might in fact result from causal mutations that are rare. One prediction of this hypothesis is that the allelic associations should be population-specific, as the causal mutations arose after the migrations that established different populations around the world. We selected 19 common variants found to be reproducibly associated to T2D risk in European populations and studied them in a large multiethnic case-control study (6,142 cases and 7,403 controls among men and women from 5 racial/ethnic groups (European Americans, African Americans, Latinos, Japanese Americans, and Native Hawaiians. In analysis pooled across ethnic groups, the allelic associations were in the same direction as the original report for all 19 variants, and 14 of the 19 were significantly associated with risk. In summing the number of risk alleles for each individual, the per-allele associations were highly statistically significant (P<10(-4 and similar in all populations (odds ratios 1.09-1.12 except in Japanese Americans the estimated effect per allele was larger than in the other populations (1.20; P(het = 3.8×10(-4. We did not observe ethnic differences in the distribution of risk that would explain the increased prevalence of type 2 diabetes in these groups as compared to European Americans. The consistency of allelic associations in diverse racial/ethnic groups is not predicted under the hypothesis of Goldstein regarding "synthetic associations" of rare mutations in T2D.
Dusser, Daniel; Wise, Robert A; Dahl, Ronald
randomized clinical trial in COPD performed to date. METHODS: A total of 17,135 patients from TIOSPIR(®) were pooled and grouped by GOLD grading (A-D) according to baseline Medical Research Council breathlessness score, exacerbation history, and spirometry. All-cause mortality and adjudicated cardiovascular...... increased consistently from Groups A-D (0.3%, 0.8%, 1.6%, and 4.2% of patients, respectively). CONCLUSION: The data obtained from the TIOSPIR(®) trial, supporting earlier studies, suggest that proportionally more CV medication and CV deaths occur in GOLD Group B COPD patients, although deaths attributed...... to respiratory causes are more prevalent in Groups C and D....
Background: Infant attachment security is a protective factor for future mental health, and may be promoted by individual interventions. Given service demands, it is important to determine if a group-based intervention for parents could be used to enhance infant attachment security. Methods: In a randomized trial involving 76 mothers, an 8-session…
Full Text Available Abstract Background Language bias is a form of publication bias and constitutes a serious threat to meta-analyses. The Cochrane Controlled Trials Register is one attempt to remedy this and now contains more than 300,000 citations. However we are still unsure if it provides comprehensive coverage, particularly for non-English trials. Methods We have recently established a comprehensive register of Japanese trials of psychotropic drugs through extensive personal contacts, electronic searches and handsearches. We examined two Cochrane psychiatry group registers against this Japanese database. Results The Japanese register contained 56 reports of randomized controlled trials (RCTs of antidepressants for depression but the Cochrane Depression, Anxiety and Neurosis group register contained 18, with an overlap of only nine. The Japanese register contained 61 reports of RCTs of neuroleptics for schizophrenia and the Cochrane Schizophrenia group register contained 36, with an overlap of only six. Taking account of some duplicate publications, only a quarter to a third of all relevant Japanese RCTs were retrievable from the Cochrane group registers. Conclusions Similar, or worse, yields may be expected with RCTs conducted in other East Asian countries, and in other fields of medicine. What evidence there is suggests that this situation may lead to a systematic over estimate of treatment effect.
Deplanque, Dominique; Sénéchal-Cohen, Sophie; Lemaire, François
Jardé's law, concerning research studies in humans, was enacted in March 2012 but did not come into force until November 2016. This delay is largely explained by the adoption of a European regulation on clinical trials on medicinal products that will probably not be applicable until October 2018. In addition to covering the respective areas of the French and European legislation, the round table provided an opportunity to discuss the principal measures that will apply to future research, particularly those concerning the operational procedures of the ethics committees and the national committee for research in humans, as well as measures relating to the management of serious adverse effects, more specifically in phase I studies in subjects not presenting with any disorder. This round table also enabled the formulation of recommendations to better anticipate the practical difficulties that the regulatory changes might engender. Finally, we highlight the numerous challenges in terms of training that these important regulatory changes impose and the absolute necessity to best adapt the restrictions to those that are planned in numerous other European countries so that France remains competitive in terms of clinical research and so that French patients may continue to benefit rapidly from the most innovative treatments. Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.
Pinkerton, C R; Ablett, S; Boos, J; Philip, T
Pan-European collaboration in studies of novel therapies and treatment strategies in childhood cancer is playing an increasing role in the attempt to improve cure rates. Differences in the systems of various countries with regard to drug control and ethical issues may lead to problems and delays. This applies in particular to phase I/II studies in children where the ethical considerations may be complex. In this review, the systems in three large countries-UK, France and Germany-are reviewed and current moves within the European Community towards a more standard approach are discussed.
Crawford, Mike J; Killaspy, Helen; Kalaitzaki, Eleftheria; Barrett, Barbara; Byford, Sarah; Patterson, Sue; Soteriou, Tony; O'Neill, Francis A; Clayton, Katie; Maratos, Anna; Barnes, Thomas R; Osborn, David; Johnson, Tony; King, Michael; Tyrer, Peter; Waller, Diana
Art Therapy has been promoted as a means of helping people who may find it difficult to express themselves verbally engage in psychological treatment. Group Art Therapy has been widely used as an adjunctive treatment for people with schizophrenia but there have been few attempts to examine its effects and cost effectiveness has not been examined. The MATISSE study aims to evaluate the clinical and cost effectiveness of group Art Therapy for people with schizophrenia. The MATISSE study is a three-arm, parallel group, pragmatic, randomised, controlled trial of referral to group Art Therapy plus standard care, referral to an attention control 'activity' group plus standard care, or standard care alone. Study participants were recruited from inpatient and community-based mental health and social care services at four centres in England and Northern Ireland. Participants were aged over 18 years with a clinical diagnosis of schizophrenia, confirmed by an examination of case notes using operationalised criteria. Participants were then randomised via an independent and remote telephone randomisation service using permuted stacked blocks, stratified by site. Art Therapy and activity groups were made available to participants once a week for up to 12 months. Outcome measures were assessed by researchers masked to allocation status at 12 and 24 months after randomisation. Participants and care givers were aware which arm of the trial participants were allocated to. The primary outcomes for the study are global functioning (measured using the Global Assessment of Functioning scale) and mental health symptoms (measured using the Positive and Negative Syndrome Scale) assessed at 24 months. Secondary outcomes were assessed at 12 and 24 months and comprise levels of group attendance, social function, satisfaction with care, mental wellbeing, and costs. We believe that this is the first large scale pragmatic trial of Art Therapy for people with schizophrenia. Current Controlled
Costa, Diogo; Matanov, Aleksandra; Canavan, Reamonn; Gabor, Edina; Greacen, Tim; Vondráčková, Petra; Kluge, Ulrike; Nicaise, Pablo; Moskalewicz, Jacek; Díaz-Olalla, José Manuel; Straßmayr, Christa; Kikkert, Martijn; Soares, Joaquim J F; Gaddini, Andrea; Barros, Henrique; Priebe, Stefan
Different service characteristics are known to influence mental health care delivery. Much less is known about the impact of contextual factors, such as the socioeconomic circumstances, on the provision of care to socially marginalized groups.The objectives of this work were to assess the organisational characteristics of services providing mental health care for marginalized groups in 14 European capital cities and to explore the associations between organisational quality, service features and country-level characteristics. 617 services were assessed in two highly deprived areas in 14 European capital cities. A Quality Index of Service Organisation (QISO) was developed and applied across all sites. Service characteristics and country level socioeconomic indicators were tested and related with the Index using linear regressions and random intercept linear models. The mean (standard deviation) of the QISO score (minimum = 0; maximum = 15) varied from 8.63 (2.23) in Ireland to 12.40 (2.07) in Hungary. The number of different programmes provided was the only service characteristic significantly correlated with the QISO (p GDP) was inversely associated with the QISO. Nearly 15% of the variance of the QISO was attributed to country-level variables, with GDP explaining 12% of this variance. Socioeconomic contextual factors, in particular the national GDP are likely to influence the organisational quality of services providing mental health care for marginalized groups. Such factors should be considered in international comparative studies. Their significance for different types of services should be explored in further research.
Iacono, M.; Villa, L.; Fortini, D.
The whole-genome sequence of an epidemic, multidrug-resistant Acinetobacter baumannii strain (strain ACICU) belonging to the European clone II group and carrying the plasmid-mediated bla(OXA-58) carbapenem resistance gene was determined. The A. baumannii ACICU genome was compared with the genomes...... of A. baumannii ATCC 17978 and Acinetobacter baylyi ADP1, with the aim of identifying novel genes related to virulence and drug resistance. A. baumannii ACICU has a single chromosome of 3,904,116 bp (which is predicted to contain 3,758 genes) and two plasmids, pACICUI and pACICU2, of 28,279 and 64...
Kearsley-Fleet, L.; Zavada, J.; Hetland, M.L.; Nordstrom, D.C.; Aaltonen, K.J.; Listing, J.; Zink, A.; Gati, T.; Rojkovich, B.; Iannone, F.; Gremese, E.; Riel, P.L.C.M. van; Laar, M.A. van der; Lie, E.; Kvien, T.K.; Canhao, H.; Fonseca, J.E.; Rotar, Z.; Loza, E.; Carmona, L.; Askling, J.; Johansson, K.; Finckh, A.; Dixon, W.G.; Hyrich, K.L.
OBJECTIVE: Under the auspices of the European League Against Rheumatism (EULAR), a study group of investigators representing European biologic DMARD (bDMARD) registers was convened. The purpose of this initial assessment was to collect and compare a cross section of patient characteristics and
Frandsen, Thomas Leth; Heyman, Mats; Abrahamsson, Jonas; Vettenranta, Kim; Åsberg, Ann; Vaitkeviciene, Goda; Pruunsild, Kaie; Toft, Nina; Birgens, Henrik; Hallböök, Helena; Quist-Paulsen, Petter; Griškevičius, Laimonas; Helt, Louise; Hansen, Birgitte Vilsbøll; Schmiegelow, Kjeld
The European Clinical Trials Directive of 2004 has increased the amount of paper work and reduced the number of initiated clinical trials. Particularly multinational trials have been delayed. To meet this challenge we developed a novel, simplified, fast and easy strategy for on-line toxicity registration for patients treated according to the Nordic/Baltic acute lymphoblastic leukaemia protocol, NOPHO ALL 2008, for children and young adults, including three randomisations. We used a risk-assessment based approach, avoiding reporting of expected adverse events and instead concentrating on 20 well-known serious, but rarer events with focus on changes in therapy introduced in the treatment protocol. This toxicity registration strategy was approved by the relevant regulatory authorities in all seven countries involved, as compliant within the EU directive of 2004. The centre compliance to registration was excellent with 98.9% of all patients being registered within 5weeks from the requested quarterly registration. Currently, four toxicities (thrombosis, fungal infections, pancreatitis and allergic reactions) have been chosen for further detailed exploration due to the cumulative fraction of patients with positive registrations exceeding 5%. This toxicity registration offers real-time toxicity profiles of the total study cohort and provides early warnings of specific toxicities that require further investigation. Copyright © 2013 Elsevier Ltd. All rights reserved.
de Groot, Femke M.; Voogt-Bode, Annieke; Passchier, Jan; Berger, Marjolein Y.; Koes, Bart W.; Verhagen, Arianne P.
Objective: The purpose of this study is to describe the effects in the placebo and "no treatment" arms in trials with headache patients. Method: This is a secondary analysis of randomized controlled trials from 8 systematic reviews and selected trials with a "no treatment" or placebo control group.
Kanorsky, S G; Mamedov, M N
Report on all six Hot Line sessions of the European Society of Cardiology Congress, 2015, is presented. These sessions were doted to studies in acute myocardial infarction, atrial fibrillation/cardiac electrical pacing, diabetes/pharmacotherapy, arterial hypertension, heart failure, and coronary artery disease.
The Large Hadron Collider (LHC) is the largest scientific instrument ever built. It has been exploring the new energy frontier since 2009, gathering a global user community of 7,000 scientists. It will remain the most powerful accelerator in the world for at least two decades, and its full exploitation is the highest priority in the European Strategy for Particle Physics, adopted by the CERN Council and integrated into the ESFRI Roadmap. To extend its discovery potential, the LHC will need a major upgrade around 2020 to increase its luminosity (rate of collisions) by a factor of 10 beyond its design value. As a highly complex and optimized machine, such an upgrade of the LHC must be carefully studied and requires about 10 years to implement. The novel machine configuration, called High Luminosity LHC (HL-LHC), will rely on a number of key innovative technologies, representing exceptional technological challenges, such as cutting-edge 13 tesla superconducting magnets, very compact and ultra-precise superconduc...
McKeag, David; Lane, Carol; Lazarus, John H; Baldeschi, Lelio; Boboridis, Kostas; Dickinson, A Jane; Hullo, A Iain; Kahaly, George; Krassas, Gerry; Marcocci, Claudio; Marinò, Michele; Mourits, Maarten P; Nardi, Marco; Neoh, Christopher; Orgiazzi, Jacques; Perros, Petros; Pinchera, Aldo; Pitz, Susanne; Prummel, Mark F; Sartini, Maria S; Wiersinga, Wilmar M
Background This study was performed to determine clinical features of dysthyroid optic neuropathy (DON) across Europe. Methods Forty seven patients with DON presented to seven European centres during one year. Local protocols for thyroid status, ophthalmic examination and further investigation were used. Each eye was classified as having definite, equivocal, or no DON. Results Graves' hyperthyroidism occurred in the majority; 20% had received radioiodine. Of 94 eyes, 55 had definite and 17 equivocal DON. Median Clinical Activity Score was 4/7 but 25% scored 3 or less, indicating severe inflammation was not essential. Best corrected visual acuity was 6/9 (Snellen) or worse in 75% of DON eyes. Colour vision was reduced in 33 eyes, of which all but one had DON. Half of the DON eyes had normal optic disc appearance. In DON eyes proptosis was > 21 mm (significant) in 66% and visual fields abnormal in 71%. Orbital imaging showed apical muscle crowding in 88% of DON patients. Optic nerve stretch and fat prolapse were infrequently reported. Conclusion Patients with DON may not have severe proptosis and orbital inflammation. Optic disc swelling, impaired colour vision and radiological evidence of apical optic nerve compression are the most useful clinical features in this series. PMID:17035276
The WGEAWESS meeting was held in Belfast, Northern Ireland (UK), on 14–18 March 2016, with nine participants from five countries. The meeting was chaired by Steven Beggs (UK (NI)) and Eider Andonegi (Spain (Basque Country)). This was the final year of the ongoing three-year terms of reference during which the group have had three meetings and one by correspondence in 2014. During the three-year period, the group has made good progress in all ToRs. The initial activity of the group has include...
Alexander, Brian M; Galanis, Evanthia; Yung, W K Alfred; Ballman, Karla V; Boyett, James M; Cloughesy, Timothy F; Degroot, John F; Huse, Jason T; Mann, Bhupinder; Mason, Warren; Mellinghoff, Ingo K; Mikkelsen, Tom; Mischel, Paul S; O'Neill, Brian P; Prados, Michael D; Sarkaria, Jann N; Tawab-Amiri, Abdul; Trippa, Lorenzo; Ye, Xiaobu; Ligon, Keith L; Berry, Donald A; Wen, Patrick Y
Glioblastoma is the most common primary brain malignancy and is associated with poor prognosis despite aggressive local and systemic therapy, which is related to a paucity of viable treatment options in both the newly diagnosed and recurrent settings. Even so, the rapidly increasing number of targeted therapies being evaluated in oncology clinical trials offers hope for the future. Given the broad range of possibilities for future trials, the Brain Malignancy Steering Committee convened a clinical trials planning meeting that was held at the Udvar-Hazy Center in Chantilly, Virginia, on September 19 and 20, 2013. This manuscript reports the deliberations leading up to the event from the Targeted Therapies Working Group and the results of the meeting. © The Author(s) 2014. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: email@example.com.
Meshinchi, Soheil; Hunger, Stephen P.; Aplenc, Richard; Adamson, Peter C.; Jessup, J. Milburn
The FDA is now exerting its regulatory authority over molecular diagnostics and their assays used for medical-decision making in clinical trials by performing pre-Investigational Device Exemption (IDE) reviews in all phases of clinical trials. This review assesses the analytical performance of the assay for the diagnostic and considers how that performance affects the diagnostic and the patient and their risks and benefits from treatment. This manuscript reviews the process of the first review that was performed on a new Children's Oncology Group (COG) Phase III trial in Acute Myelogenous Leukemia. The lessons learned and recommendations for how to prepare for and incorporate this new level of regulatory review into the protocol development process are presented. PMID:22422407
Gullberg, Anne Therese [CICERO, Pb 1129 Blindern, N-0318 Oslo (Norway)
Drawing on two conflicting hypotheses from the theoretical literature on lobbying, I consider the strategies applied by interest groups lobbying to influence climate policy in the European Union (EU). The first hypothesis claims that interest groups lobby their 'friends', decision-makers with positions similar to their own. The second claims that interest groups lobby their 'foes', decision-makers with positions opposed to their own. Using interviews with lobbyists and decision-makers, I demonstrate that in the field of climate policy, interest groups in the EU lobby both friends and foes, but under different conditions. Moreover, I find that the interest groups' motives are not always in line with the theoretical hypotheses. Interest groups lobby their friends on single policy decisions to exchange information, to further a common cause and to exert pressure, and their foes because a foe on one issue might prove to be a friend on another issue. Interest groups direct general lobbying towards both friends and foes. This paper provides a new empirical contribution to a literature that has so far been heavily dominated by studies focusing on lobbying in the US. (author)
Boesen, E. H.; Karlsen, R.; Christensen, J.
Purpose: To test the effectiveness of a psycho-educational group intervention to improve psychological distress measured by POMS TMD, Quality of Life measured by European Organisation for Research and Treatment of Cancer (EORTC), the core and breast cancer module, Mental Adjustment measured by MAC...... improved over time, in both the control and intervention groups. Conclusion: Psycho-education and group psychotherapy did not decrease psychological distress or increase Quality of Life, Mental Adjustment or improve marital relationship among patients with primary breast cancer. (C) 2011 Published...... were offered two weekly 6-h sessions of psycho-education and eight weekly 2-h sessions of group psychotherapy. All participants were followed up for Quality of Life, coping ability and social relations 1, 6 and 12 months after the intervention and on survival 4 years after surgical treatment. Results...
Debruyne, F M; Jardin, A; Colloi, D; Resel, L; Witjes, W P; Delauche-Cavallier, M C; McCarthy, C; Geffriaud-Ricouard, C
To assess the additive benefit of combining an alpha1-blocker and a 5alpha-reductase inhibitor. This European, randomized, double-blind, multicenter trial involved 1.051 patients with lower urinary tract symptoms related to benign prostatic hyperplasia. Patients received sustained release (SR) alfuzosin (n = 358), a selective alpha1-blocker given at a dose of 5 mg twice daily without dose titration; finasteride (n = 344), 5 mg once daily, or both drugs (n = 349), for 6 months. Primary efficacy criteria were symptomatic improvement (International Prostate Symptom Score: I-PSS) and maximum flow rate (Qmax). Safety was assessed by monitoring adverse events. Symptomatic improvement was significantly higher from the 1st month of treatment with SR alfuzosin, alone or in combination; mean changes in I-PSS versus baseline at end-point were -6.3 and -6.1, respectively, compared with -5.2 with finasteride alone (SR alfuzosin vs. finasteride, p = 0.01; combination vs. finasteride, p = 0.03). The percentages of patients with a decrease in I-PSS of at least 50% were 43, 42 and 33% for SR alfuzosin, the combination and finasteride, respectively (SR alfuzosin vs. finasteride, p = 0.008; combination vs. finasteride, p = 0.009). In the overall population, increases in Qmax were greater with SR alfuzosin and the combination, compared with finasteride alone after 1 month of therapy, but changes at end-point were similar in the three treatment groups. In those 47% of patients likely to be obstructed (baseline Qmax <10 ml/s), however, mean increases in Qmax were significantly higher with SR alfuzosin, alone or in combination, whatever the visit. Finasteride, alone or in combination, significantly impaired sexual function. The incidence of postural symptoms was low and similar in the three treatment groups. In this 6-month trial, SR alfuzosin was more effective than finasteride, with no additional benefit in combining both drugs.
Fairchild, Alysa, E-mail: firstname.lastname@example.org [Department of Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta (Canada); Straube, William [Advanced Technology Consortium, Imaged-Guided Therapy QA Center, St. Louis, Missouri (United States); Laurie, Fran [Quality Assurance Review Center, Lincoln, Rhode Island (United States); Followill, David [Radiological Physics Center, University of Texas MD Anderson Cancer Centre, Houston, Texas (United States)
Central review of radiation therapy (RT) delivery within multicenter clinical trials was initiated in the early 1970s in the United States. Early quality assurance publications often focused on metrics related to process, logistics, and timing. Our objective was to review the available evidence supporting correlation of RT quality with clinical outcomes within cooperative group trials. A MEDLINE search was performed to identify multicenter studies that described central subjective assessment of RT protocol compliance (quality). Data abstracted included method of central review, definition of deviations, and clinical outcomes. Seventeen multicenter studies (1980-2012) were identified, plus one Patterns of Care Study. Disease sites were hematologic, head and neck, lung, breast, and pancreas. Between 0 and 97% of treatment plans received an overall grade of acceptable. In 7 trials, failure rates were significantly higher after inadequate versus adequate RT. Five of 9 and 2 of 5 trials reported significantly worse overall and progression-free survival after poor-quality RT, respectively. One reported a significant correlation, and 2 reported nonsignificant trends toward increased toxicity with noncompliant RT. Although more data are required, protocol-compliant RT may decrease failure rates and increase overall survival and likely contributes to the ability of collected data to answer the central trial question.
Background Despite the popularity of hypnotherapy for smoking cessation, the efficacy of this method is unclear. We aimed to investigate the efficacy of a single-session of group hypnotherapy for smoking cessation compared to relaxation in Swiss adult smokers. Methods This was a cluster-randomised, parallel-group, controlled trial. A single session of hypnosis or relaxation for smoking cessation was delivered to groups of smokers (median size = 11). Participants were 223 smokers consuming ≥ 5 cigarettes per day, willing to quit and not using cessation aids (47.1% females, M = 37.5 years [SD = 11.8], 86.1% Swiss). Nicotine withdrawal, smoking abstinence self-efficacy, and adverse reactions were assessed at a 2-week follow-up. The main outcome, self-reported 30-day point prevalence of smoking abstinence, was assessed at a 6-month follow up. Abstinence was validated through salivary analysis. Secondary outcomes included number of cigarettes smoked per day, smoking abstinence self-efficacy, and nicotine withdrawal. Results At the 6-month follow up, 14.7% in the hypnosis group and 17.8% in the relaxation group were abstinent. The intervention had no effect on smoking status (p = .73) or on the number of cigarettes smoked per day (p = .56). Smoking abstinence self-efficacy did not differ between the interventions (p = .14) at the 2-week follow-up, but non-smokers in the hypnosis group experienced reduced withdrawal (p = .02). Both interventions produced few adverse reactions (p = .81). Conclusions A single session of group hypnotherapy does not appear to be more effective for smoking cessation than a group relaxation session. Trial registration Current Controlled Trials ISRCTN72839675. PMID:24365274
Fleming, Andrew P; McMahon, Robert J; Moran, Lyndsey R; Peterson, A Paige; Dreessen, Anthony
ADHD affects between 2% and 8% of college students and is associated with broad functional impairment. No prior randomized controlled trials with this population have been published. The present study is a pilot randomized controlled trial evaluating dialectical behavior therapy (DBT) group skills training adapted for college students with ADHD. Thirty-three undergraduates with ADHD between ages 18 and 24 were randomized to receive either DBT group skills training or skills handouts during an 8-week intervention phase. ADHD symptoms, executive functioning (EF), and related outcomes were assessed at baseline, post-treatment, and 3-month follow-up. Participants receiving DBT group skills training showed greater treatment response rates (59-65% vs. 19-25%) and clinical recovery rates (53-59% vs. 6-13%) on ADHD symptoms and EF, and greater improvements in quality of life. DBT group skills training may be efficacious, acceptable, and feasible for treating ADHD among college students. A larger randomized trial is needed for further evaluation. © 2014 SAGE Publications.
Cardiovascular considerations of attention deficit hyperactivity disorder medications: a report of the European Network on Hyperactivity Disorders work group, European Attention Deficit Hyperactivity Disorder Guidelines Group on attention deficit hyperactivity disorder drug safety meeting.
Hamilton, Robert M; Rosenthal, Eric; Hulpke-Wette, Martin; Graham, John G I; Sergeant, Joseph
Regulatory decisions regarding attention deficit hyperactivity disorder drug licensing and labelling, along with recent statements from professional associations, raise questions of practice regarding the evaluation and treatment of patients with attention deficit hyperactivity disorder. To address these issues for the European community, the European Network for Hyperkinetic Disorders, through its European Attention Deficit Hyperactivity Disorder Guidelines Group, organised a meeting between attention deficit hyperactivity disorder specialists, paediatric cardiovascular specialists, and representatives of the major market authorisation holders for attention deficit hyperactivity disorder medications. This manuscript represents their consensus on cardiovascular aspects of attention deficit hyperactivity disorder medications. Although sudden death has been identified in multiple young individuals on attention deficit hyperactivity disorder medication causing regulatory concern, when analysed for exposure using currently available data, sudden death does not appear to exceed that of the general population. There is no current evidence to suggest an incremental benefit to electrocardiography assessment of the general attention deficit hyperactivity disorder patient. Congenital heart disease patients have an increased prevalence of attention deficit hyperactivity disorder, and can benefit from attention deficit hyperactivity disorder therapies, including medication. The attention deficit hyperactivity disorder specialist is the appropriate individual to evaluate benefit and risk and recommend therapy in all patients, although discussion with a heart specialist is reasonable for congenital heart disease patients. For attention deficit hyperactivity disorder patients with suspected heart disease or risk factor/s for sudden death, assessment by a heart specialist is recommended, as would also be the case for a non-attention deficit hyperactivity disorder patient. The
Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne
Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This preliminary randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive behavioural therapy and recreational activity. Both interventions comprised 36 weekly 3-h sessions led by two therapists in groups of 6-8 patients. A total of 68 psychiatric patients with autism spectrum disorders participated in the study. Outcome measures were Quality of Life Inventory, Sense of Coherence Scale, Rosenberg Self-Esteem Scale and an exploratory analysis on measures of psychiatric health. Participants in both treatment conditions reported an increased quality of life at post-treatment (d = 0.39, p autism spectrum disorder. The interventions' similar efficacy may be due to the common elements, structure and group setting. Cognitive behavioural therapy may be additionally beneficial in terms of increasing specific skills and minimizing dropout. © The Author(s) 2013.
Charron, Philippe; Arad, Michael; Arbustini, Eloisa; Basso, Cristina; Bilinska, Zofia; Elliott, Perry; Helio, Tiina; Keren, Ane; McKenna, William J; Monserrat, Lorenzo; Pankuweit, Sabine; Perrot, Aneas; Rapezzi, Claudio; Ristic, Arsen; Seggewiss, Hubert; van Langen, Irene; Tavazzi, Luigi
.... The aims of this position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases are to review the general issues related to genetic counselling, family...
EURYDICE European Unit, Brussels (Belgium).
This report offers the agenda for a meeting in Budapest in November 1996 of the Thesaurus Management Group of the Council of Europe. The report includes a list of participants, a report on previous meetings, information on availability of the 1991 version of the thesaurus and subsequent addenda, information on new versions to be created, and a…
Ferriere, Michael; Van Ness, Brian
The NCI funded cooperative group cancer clinical trial system develops experimental therapies and often collects patient samples for correlative research. The Cooperative Group Bank (CGB) system maintains biobanks with a current policy not to return research results to individuals. An online survey was created, and 10 directors of CGBs completed the surveys asking about understanding and attitudes in changing policies to consider return of Incidental Findings (IFs) and Individual Research Results (IRRs) of health significance. The potential impact of the ten consensus recommendations of Wolf et al. presented in this issue are examined. Re-identification of samples is often not problematic; however, changes to the current banking and clinical trial systems would require significant effort to fulfill an obligation of recontact of subjects. Additional resources, as well as a national advisory board would be required to standardize implementation. PMID:22382800
Ferriere, Michael; Van Ness, Brian
The National Cancer Institute (NCI)-funded cooperative group cancer clinical trial system develops experimental therapies and often collects samples from patients for correlative research. The cooperative group bank (CGB) system maintains biobanks with a current policy not to return research results to individuals. An online survey was created, and 10 directors of CGBs completed the surveys asking about understanding and attitudes in changing policies to consider return of incidental findings (IFs) and individual research results (IRRs) of health significance. The potential impact of the 10 consensus recommendations of Wolf et al. presented in this issue are examined. Reidentification of samples is often not problematic; however, changes to the current banking and clinical trial systems would require significant effort to fulfill an obligation of recontact of subjects. Additional resources, as well as a national advisory board would be required to standardize implementation.
Endothelial factors in the pathogenesis and treatment of chronic kidney disease Part II: Role in disease conditions: a joint consensus statement from the European Society of Hypertension Working Group on Endothelin and Endothelial Factors and the Japanese Society of Hypertension.
Rossi, Gian Paolo; Seccia, Teresa M; Barton, Matthias; Danser, A H Jan; de Leeuw, Peter W; Dhaun, Neeraj; Rizzoni, Damiano; Rossignol, Patrick; Ruilope, Luis-Miguel; van den Meiracker, Anton H; Ito, Sadayoshi; Hasebe, Naoyuki; Webb, David J
: After examining in Part I the general mechanisms of endothelial cell injury in the kidney, the Working Group on Endothelin and Endothelial Factors of the European Society of Hypertension and the Japanese Society of Hypertension will herein review current knowledge on the role of endothelial dysfunction in multiple disease conditions that affect the kidney, including diabetes mellitus, preeclampsia, solid organ transplantation, hyperhomocysteinemia and antiangiogenic therapy in cancer. The few available randomized controlled clinical trials specifically designed to evaluate strategies for correcting endothelial dysfunction in patients with hypertension and/or chronic kidney disease are also discussed alongside their cardiovascular and renal outcomes.
Pinol, A; Bergel, E; Chaisiri, K; Diaz, E; Gandeh, M
The World Health Organisation, in collaboration with four developing countries, is conducting a randomised controlled clinical trial to evaluate a new programme of antenatal care. In a city or region in Argentina, Cuba, Saudi Arabia and Thailand, 53 clinical units were randomly allocated to provide either the new programme or the programme currently in use. This paper describes the organisation of the data management system used to collect the data. Each woman participating in the trial is uniquely identified, and information such as her name, address and expected delivery date is recorded in the trial 'subject number list'. If the clinic belongs to the intervention group, information about the woman's eligibility is recorded on the classification form. Details of the outcome of the pregnancy are indicated on two additional case report forms: the antenatal hospital admission form and the summary form. When forms are completed by the investigators, they are submitted to the country data coordinating centre (CDCC). The CDCCs are responsible for the processing of the country study forms. This includes verification of the batch of forms, data capture into computer files, data verification, data validation, production of query sheets for data problems, maintenance and updating of study master files. All operations on data such as additions or modifications are performed using transaction processing. At monthly intervals, recruitment reports and transaction files are sent to the trial coordinating centre in Geneva. All transaction files are processed to accumulate data on the trial's consolidated master files. A monthly report including number of women recruited in the trial, adverse events reported by the countries, recruitment charts by clinic and analyses on eligible women in the intervention group is prepared and submitted to the data safety and monitoring committee. A workshop was organised in 1995, before the start of the trial, to introduce the data management
Meta van der Linden
Full Text Available The aim of this study is twofold. First, we expand on the literature by testing whether generalized trust is negatively related to anti-immigrant sentiments in Europe. Second, we examine to what extent the relation between generalized trust and anti-immigrant sentiments is dependent upon cross-group friendships. We apply multilevel linear regression modeling to representative survey data enriched with levels of ethnic diversity covering 21 European countries. Results show that both generalized trust and cross-group friendship are negatively related to anti-immigrant sentiments. However, there is a negligible positive relation between generalized trust and cross-group friendship (r = .10, and we can clearly observe that they operate independently from one another. Hence, trusting actors are not more likely to form more cross-group friendships, and cross-group friendship do not lead to the development of more generalized trust. Instead, the findings show that generalized trust leads immigrants too to be included in the radius of trusted others and, as a consequence, the benign effects of generalized trust apply to them as well. We conclude that the strength of generalized trust is a form of generalization, beyond the confines of individual variations in intergroup experiences.
van der Linden, Meta; Hooghe, Marc; de Vroome, Thomas; Van Laar, Colette
The aim of this study is twofold. First, we expand on the literature by testing whether generalized trust is negatively related to anti-immigrant sentiments in Europe. Second, we examine to what extent the relation between generalized trust and anti-immigrant sentiments is dependent upon cross-group friendships. We apply multilevel linear regression modeling to representative survey data enriched with levels of ethnic diversity covering 21 European countries. Results show that both generalized trust and cross-group friendship are negatively related to anti-immigrant sentiments. However, there is a negligible positive relation between generalized trust and cross-group friendship (r = .10), and we can clearly observe that they operate independently from one another. Hence, trusting actors are not more likely to form more cross-group friendships, and cross-group friendship do not lead to the development of more generalized trust. Instead, the findings show that generalized trust leads immigrants too to be included in the radius of trusted others and, as a consequence, the benign effects of generalized trust apply to them as well. We conclude that the strength of generalized trust is a form of generalization, beyond the confines of individual variations in intergroup experiences.
Glassman, Jill R.; Potter, Susan C.; Baumler, Elizabeth R.; Coyle, Karin K.
Introduction: Group-randomized trials (GRTs) are one of the most rigorous methods for evaluating the effectiveness of group-based health risk prevention programs. Efficiently designing GRTs with a sample size that is sufficient for meeting the trial's power and precision goals while not wasting resources exceeding them requires estimates of the…
Cazes, C; Rosnet, E; Bachelard, C; Le Scanff, C; Rivolier, J
The objectives of this study were to investigate the social behavior, interrelations, cohesion, efficiency and team formation of the crew during 60 days of isolation and confinement, to make a critical comparison of a variety of test methods used for this purpose and to formulate recommendations for their applications in selection, training and support for future studies of this kind. The study consisted of three phases: (1) the pre-isolation period, in which initial individual and group assessment were made to understand the motivation, characteristics, and styles of the crew members, the state of the crew, and to make a prognosis for the behavior of the group and its members, (2) the isolation period, with tests and observations to follow and analyze behavior and group dynamics of the crew, and to detect manifestations of stress, and (3) the post-isolation period with final assessment and debriefing. During these three periods individual and group tests were carried out. Direct methods, questionnaires and tests, as well as indirect methods, observations of behavior, were used. These had cognitive, affective-emotional and social components; they were quantitative, qualitative or a combination. Before isolation the crew members expressed strong confidence in the team and in their own personal capability. The leadership of the Commander seemed uncontested. Crew functioning during this period was conflict-free, but was structured in a rather rigid and defensive way (isolation of affects, denial of anxiety). Apparently, the members strongly needed to present a good image image of themselves. The relatively short period of the experiment, and the absence of real risk suggested that the crew would be able to maintain their cohesion, but in a real spaceflight situation this behavior could be inadequate and even dangerous. The pre-isolation prognosis for crew behavior during isolation was validated to a large extent. During isolation there were no clear manifestations of
Sauerwein, W; Moss, R; Rassow, J; Stecher-Rasmussen, F; Hideghéty, K; Wolbers, J G; Sack, H
Boron Neutron Capture Therapy is based on the ability of the isotope 10B to capture thermal neutrons and to disintegrate instantaneously producing high LET particles. The only neutron beam available in Europe for such a treatment is based at the European High Flux Reactor HFR at Petten (The Netherlands). The European Commission, owners of the reactor, decided that the potential benefit of the facility should be opened to all European citizens and therefore insisted on a multinational approach to perform the first clinical trial in Europe on BNCT. This precondition had to be respected as well as the national laws and regulations. Together with the Dutch authorities actions were undertaken to overcome the obvious legal problems. Furthermore, the clinical trial at Petten takes place in a nuclear research reactor, which apart from being conducted in a non-hospital environment, is per se known to be dangerous. It was therefore of the utmost importance that special attention is given to safety, beyond normal rules, and to the training of staff. In itself, the trial is an unusual Phase I study, introducing a new drug with a new irradiation modality, with really an unknown dose-effect relationship. This trial must follow optimal procedures, which underscore the quality and qualified manner of performance.
Spahn, D R; van Brempt, R; Theilmeier, G; Reibold, J P; Welte, M; Heinzerling, H; Birck, K M; Keipert, P E; Messmer, K; Heinzerling, H; Birck, K M; Keipert, P E; Messmer, K
Fluorocarbon emulsions have been proposed as temporary artificial oxygen carriers. The aim of the present study is to compare the effectiveness of perflubron emulsion with the effectiveness of autologous blood or colloid infusion for reversal of physiologic transfusion triggers. A multinational, multicenter, randomized, controlled, single-blind, parallel group study was performed in 147 orthopedic patients. Patients underwent acute normovolemic hemodilution with colloid to a target hemoglobin of 9 g/dl with an inspiratory oxygen fraction (FIO2) of 0.40. Patients were then randomized into one of four treatment groups after having reached any of the protocol-defined transfusion triggers including tachycardia (heart rate > 125% of posthemodilution rate or > 110 bpm), hypotension (mean arterial pressure 150% of posthemodilution level) or decreased mixed venous oxygen partial pressure (PVO2; emulsion with colloid (total = 450 ml) at FIO2 = 1.0; and 1.8 g/kg perflubron emulsion with colloid (total = 450 ml) at FIO2 = 1.0. The primary endpoint was duration of transfusion-trigger reversal. A secondary end-point was percentage of transfusion-trigger reversal. Perflubron emulsion was well tolerated with no serious adverse event attributed to drug treatment. Duration of reversal was longest in the 1.8 g/kg perflubron group (median, 80 min; 95% confidence interval, 60-100 min; P = 0.014 vs. autologous blood, P emulsion (1.8 g/kg) combined with 100% oxygen ventilation is more effective than autologous blood or colloid infusion in reversing physiologic transfusion triggers.
Felson, David T.; Smolen, Josef S.; Wells, George; Zhang, Bin; van Tuyl, Lilian H. D.; Funovits, Julia; Aletaha, Daniel; Allaart, Renée; Bathon, Joan; Bombardieri, Stefano; Brooks, Peter; Brown, Andrew; Matucci-Cerinic, Marco; Choi, Hyon; Combe, Bernard; de Wit, Maarten; Dougados, Maxime; Emery, Paul; Furst, Dan; Gomez-Reino, Juan; Hawker , Gillian; Keystone, Edward; Khanna, Dinesh; Kirwan, John; Kvien, Tore; Landewé, Robert; Listing, Joachim; Michaud, Kaleb; Mola, Emilio Martin; Montie, Pam; Pincus, Ted; Richards, Pam; Siegel, Jeff; Simon, Lee; Sokka, Tuulikki; Strand, Vibeke; Tugwell, Peter; Tyndall, Alan; van der Heijde, Desirée; Verstappen, Suzan; White, Barbara; Wolfe, Fred; Zink, Angela; Boers, Maarten
Background With remission in rheumatoid arthritis (RA) an increasingly attainable goal, there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome in clinical trials. Methods A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism and the Outcome Measures in Rheumatology Initiative (OMERACT) met to guide the process and review prespecified analyses from clinical trials of patients with RA. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures to define remission including at least joint counts and an acute phase reactant. Members were surveyed to select the level of each core set measure consistent with remission. Candidate definitions of remission were tested including those that constituted a number of individual measures in remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analyzed to examine the added contribution of patient reported outcomes and the ability of candidate measures to predict later good x-ray and functional outcomes. Results Survey results for the definition of remission pointed to indexes at published thresholds and to a count of core set measures with each measure scored as 1 or less (e.g. tender and swollen joint counts, CRP and global assessments on 0-10 scale). Analyses suggested the need to include a patient reported measure. Examination of 2 year follow-up data suggested that many candidate definitions performed comparably in terms of predicting later good x-ray and functional outcomes, although DAS28 based measures of remission did not predict good radiographic outcomes as well as did the other candidate definitions. Given these and other considerations, we propose that a patient be defined as in remission based on one of two definitions : 1: When their scores on the
Galanis, Evanthia; Wu, Wenting; Cloughesy, Timothy; Lamborn, Kathleen; Mann, Bhupinder; Wen, Patrick Y; Reardon, David A; Wick, Wolfgang; Macdonald, David; Armstrong, Terri S; Weller, Michael; Vogelbaum, Michael; Colman, Howard; Sargent, Daniel J; van den Bent, Martin J; Gilbert, Mark; Chang, Susan
Advances in the management of gliomas, including the approval of agents such as temozolomide and bevacizumab, have created an evolving therapeutic landscape in glioma treatment, thus affecting our ability to reliably use historical controls to comparatively assess the activity of new therapies. Furthermore, the increasing availability of novel, targeted agents--which are competing for a small patient population, in view of the low incidence of primary brain tumours--draws attention to the need to improve the efficiency of phase 2 clinical testing in neuro-oncology to expeditiously transition the most promising of these drugs or combinations to potentially practice-changing phase 3 trials. In this report from the Response Assessment in Neurooncology (RANO) group, we review phase 2 trial designs that can address these challenges and capitalise on scientific and clinical advances in brain tumour treatment in neuro-oncology to accelerate and optimise the selection of drugs deserving further testing in phase 3 trials. Although there is still a small role for single-arm and non-comparative phase 2 designs, emphasis is placed on the potential role that comparative randomised phase 2 designs--such as screening designs, selection designs, discontinuation designs, and adaptive designs, including seamless phase 2/3 designs--can have. The rational incorporation of these designs, as determined by the specific clinical setting and the trial's endpoints or goals, has the potential to substantially advance new drug development in neuro-oncology. Copyright © 2012 Elsevier Ltd. All rights reserved.
Subtrochanteric fractures after long-term treatment with bisphosphonates: a European Society on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis, and International Osteoporosis Foundation Working Group Report.
Rizzoli, R; Akesson, K; Bouxsein, M; Kanis, J A; Napoli, N; Papapoulos, S; Reginster, J-Y; Cooper, C
This paper reviews the evidence for an association between atypical subtrochanteric fractures and long-term bisphosphonate use. Clinical case reports/reviews and case-control studies report this association, but retrospective phase III trial analyses show no increased risk. Bisphosphonate use may be associated with atypical subtrochanteric fractures, but the case is yet unproven. A Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis and the International Osteoporosis Foundation has reviewed the evidence for a causal association between subtrochanteric fractures and long-term treatment with bisphosphonates, with the aim of identifying areas for further research and providing recommendations for physicians. A PubMed search of literature from 1994 to May 2010 was performed using key search terms, and articles pertinent to subtrochanteric fractures following bisphosphonate use were analysed. Several clinical case reports and case reviews report a possible association between atypical fractures at the subtrochanteric region of the femur in bisphosphonate-treated patients. Common features of these 'atypical' fractures include prodromal pain, occurrence with minimal/no trauma, a thickened diaphyseal cortex and transverse fracture pattern. Some small case-control studies report the same association, but a large register-based study and retrospective analyses of phase III trials of bisphosphonates do not show an increased risk of subtrochanteric fractures with bisphosphonate use. The number of atypical subtrochanteric fractures in association with bisphosphonates is an estimated one per 1,000 per year. It is recommended that physicians remain vigilant in assessing their patients treated with bisphosphonates for the treatment or prevention of osteoporosis and advise patients of the potential risks. Bisphosphonate use may be associated with atypical subtrochanteric fractures, but the case is unproven and requires further
A European multi-center trial investigating the anti-restenotic effect of intravascular sonotherapy after stenting of de novo lesions (EUROSPAH: EUROpean Sonotherapy Prevention of Arterial Hyperplasia).
Serruys, P W; Hoye, A; Grollier, G; Colombo, A; Symons, J; Mudra, H
Intravascular sonotherapy (IST) reduces neointimal hyperplasia post-stenting in animal studies. Euro-SPAH is a multi-center, double blind, randomized trial investigating the efficacy of IST to reduce in-stent late loss. Patients with angina or silent ischaemia with stented de novo lesions were randomised to sham or IST. The sample size had a 90% power to detect a late loss difference of 0.21 mm at 6 months. The secondary endpoints were MACE at 1, 6, 12 months and neo-intimal hyperplasia on IVUS at 6 months. At 23 sites in Europe, 403 patients were randomized, with successful treatment with sham or IST in 95.6%. There were no significant differences between the groups in terms of baseline demographics or lesion characteristics. Angiographic follow-up was obtained in 89%. In-stent late loss was not significantly different. The restenosis rate at 6 months was 23% in the IST group versus 25% in the sham group. The IVUS measurements confirm the absence of effect of IST on neointimal hyperplasia. At one year, the event-free survival did not significantly differ between the two groups. The use of sonotherapy following stent implantation in de novo lesions does not reduce intra-stent neointimal hyperplasia, or effect the angiographic restenosis rate compared to sham treatment.
Morrow, Jay B; Dallo, Florence J; Julka, Manjula
The objective of this review was to summarize the current literature of community-based colorectal cancer screening randomized controlled trials with multi-ethnic groups. The CDC reports 40% of adults do not receive time-appropriate colorectal cancer screening. Although overall screening rates have improved since 2000, disparities remain. Studies examining community characteristics may offer insight into improving screening rates and eliminating disparities. We identified community-based colorectal cancer screening studies using PubMed and Ovid Medline database searches. Inclusion criteria were: community-based, randomized controlled trials; English language; published from 1/2001 to 8/2009; all colorectal cancer screening test interventions recommended in the 2008 "Joint Consensus" report; and study participants from at least two racial/ethnic groups, with not more than 90% representation from one group. There were 29 relevant articles published during 2001-2009; with 15 meeting inclusion criteria. We categorized the final studies (n = 15) into the four categories of Patient mailings (n = 3), Telephone outreach (n = 3), Electronic/multimedia (n = 4), and Counseling/community education (n = 5). Of 15 studies, 11 (73%) demonstrated increased screening rates for the intervention group compared to controls, including all studies (100%) from the Patient mailings and Telephone outreach groups, 4 of 5 (80%) Counseling/community education studies, and 1 of 4 (25%) Electronic/multimedia interventions. Patient choice and tailoring of information were common features of trials that increased screening rates across study categories. Including community-level factors and social context may be useful in future design and evaluation of colorectal cancer interventions to reduce or prevent new cases of colorectal cancer.
Hynes, Helen; Stoyanov, Slavi; Drachsler, Hendrik; Maher, Bridget; Orrego, Carola; Stieger, Lina; Druener, Susanne; Sopka, Sasa; Schröder, Hanna; Henn, Patrick
To develop, by consultation with an expert group, agreed learning outcomes for the teaching of handoff to medical students using group concept mapping. In 2013, the authors used group concept mapping, a structured mixed-methods approach, applying both quantitative and qualitative measures to identify an expert group's common understanding about the learning outcomes for training medical students in handoff. Participants from four European countries generated and sorted ideas, then rated generated themes by importance and difficulty to achieve. The research team applied multidimensional scaling and hierarchical cluster analysis to analyze the themes. Of 127 experts invited, 45 contributed to the brainstorming session. Twenty-two of the 45 (48%) completed pruning, sorting, and rating phases. They identified 10 themes with which to select learning outcomes and operationally define them to form a basis for a curriculum on handoff training. The themes "Being able to perform handoff accurately" and "Demonstrate proficiency in handoff in workplace" were rated as most important. "Demonstrate proficiency in handoff in simulation" and "Engage with colleagues, patients, and carers" were rated most difficult to achieve. The study identified expert consensus for designing learning outcomes for handoff training for medical students. Those outcomes considered most important were among those considered most difficult to achieve. There is an urgent need to address the preparation of newly qualified doctors to be proficient in handoff at the point of graduation; otherwise, this is a latent error within health care systems. This is a first step in this process.
Orbach, Daniel; Brennan, Bernadette; De Paoli, Angela; Gallego, Soledad; Mudry, Peter; Francotte, Nadine; van Noesel, Max; Kelsey, Anna; Alaggio, Rita; Ranchère, Dominique; De Salvo, Gian Luca; Casanova, Michela; Bergeron, Christophe; Merks, Johannes H M; Jenney, Meriel; Stevens, Michael C G; Bisogno, Gianni; Ferrari, Andrea
Infantile fibrosarcoma (IFS) is a very rare disease occurring in young infants characterised by a high local aggressiveness but overall with a favourable survival. To try to reduce the total burden of therapy, the European pediatric Soft tissue sarcoma Study Group has developed conservative therapeutic recommendations according to initial resectability. Between 2005 and 2012, children with localised IFS were prospectively registered. Initial surgery was suggested only if possible without mutilation. Patients with initial complete (IRS-group I/R0) or microscopic incomplete (group II/R1) resection had no further therapy. Patients with initial inoperable tumour (group III/R2) received first-line vincristine-actinomycin-D chemotherapy (VA). Delayed conservative surgery was planned after tumour reduction. Aggressive local therapy (mutilating surgery or external radiotherapy) was discouraged. A total of 50 infants (median age 1.4 months), were included in the study. ETV6-NTRK3 transcript was present in 87.2% of patients where investigation was performed. According to initial surgery, 11 patients were classified as group I, 8 as group II and 31 as group III. VA chemotherapy was first delivered to 25 children with IRS-III/R2 and one with IRS-II/R1 disease. Response rate to VA was 68.0%. Mutilating surgery was only performed in three cases. After a median follow-up of 4.7 years (range 1.9-9.0), 3-year event-free survival and overall survival were respectively 84.0% (95% confidence interval [CI] 70.5-91.7) and 94.0% (95% CI 82.5-98.0). Conservative therapy is possible in IFS as only three children required mutilating surgery, and alkylating or anthracycline based chemotherapy was avoided in 71.0% of patients needing chemotherapy. VA regimen should be first line therapy in order to reduce long term effects. Copyright © 2016 Elsevier Ltd. All rights reserved.
Dickson-Spillmann, Maria; Haug, Severin; Schaub, Michael P
Despite the popularity of hypnotherapy for smoking cessation, the efficacy of this method is unclear. We aimed to investigate the efficacy of a single-session of group hypnotherapy for smoking cessation compared to relaxation in Swiss adult smokers. This was a cluster-randomised, parallel-group, controlled trial. A single session of hypnosis or relaxation for smoking cessation was delivered to groups of smokers (median size = 11). Participants were 223 smokers consuming ≥ 5 cigarettes per day, willing to quit and not using cessation aids (47.1% females, M = 37.5 years [SD = 11.8], 86.1% Swiss). Nicotine withdrawal, smoking abstinence self-efficacy, and adverse reactions were assessed at a 2-week follow-up. The main outcome, self-reported 30-day point prevalence of smoking abstinence, was assessed at a 6-month follow up. Abstinence was validated through salivary analysis. Secondary outcomes included number of cigarettes smoked per day, smoking abstinence self-efficacy, and nicotine withdrawal. At the 6-month follow up, 14.7% in the hypnosis group and 17.8% in the relaxation group were abstinent. The intervention had no effect on smoking status (p = .73) or on the number of cigarettes smoked per day (p = .56). Smoking abstinence self-efficacy did not differ between the interventions (p = .14) at the 2-week follow-up, but non-smokers in the hypnosis group experienced reduced withdrawal (p = .02). Both interventions produced few adverse reactions (p = .81). A single session of group hypnotherapy does not appear to be more effective for smoking cessation than a group relaxation session. Current Controlled Trials ISRCTN72839675.
Møller, Peter; Möller, Lennart; Godschalk, Roger W L
The alkaline single cell gel electrophoresis (comet) assay has become a widely used method for the detection of DNA damage and repair in cells and tissues. Still, it has been difficult to compare results from different investigators because of differences in assay conditions and because the data...... are reported in different units. The European Comet Assay Validation Group (ECVAG) was established for the purpose of validation of the comet assay with respect to measures of DNA damage formation and its repair. The results from this inter-laboratory validation trail showed a large variation in measured level...... reliability for the measurement of DNA damage by the comet assay but there is still a need for further validation to reduce both assay and inter-laboratory variation....
Scotti, Oona; Peruzza, Laura
The key questions we ask are: What is the best strategy to fill in the gap in knowledge and know-how in Europe when considering faults in seismic hazard assessments? Are field geologists providing the relevant information for seismic hazard assessment? Are seismic hazard analysts interpreting field data appropriately? Is the full range of uncertainties associated with the characterization of faults correctly understood and propagated in the computations? How can fault-modellers contribute to a better representation of the long-term behaviour of fault-networks in seismic hazard studies? Providing answers to these questions is fundamental, in order to reduce the consequences of future earthquakes and improve the reliability of seismic hazard assessments. An informal working group was thus created at a meeting in Paris in November 2014, partly financed by the Institute of Radioprotection and Nuclear Safety, with the aim to motivate exchanges between field geologists, fault modellers and seismic hazard practitioners. A variety of approaches were presented at the meeting and a clear gap emerged between some field geologists, that are not necessarily familiar with probabilistic seismic hazard assessment methods and needs and practitioners that do not necessarily propagate the "full" uncertainty associated with the characterization of faults. The group thus decided to meet again a year later in Chieti (Italy), to share concepts and ideas through a specific exercise on a test case study. Some solutions emerged but many problems of seismic source characterizations with people working in the field as well as with people tackling models of interacting faults remained. Now, in Wien, we want to open the group and launch a call for the European community at large to contribute to the discussion. The 2016 EGU session Fault2SHA is motivated by such an urgency to increase the number of round tables on this topic and debate on the peculiarities of using faults in seismic hazard
Kuhle, J.; Hardmeier, M.; Disanto, G.; Gugleta, K.; Ecsedi, M.; Lienert, C.; Amato, M. P.; Baum, K.; Buttmann, M.; Bayas, A.; Brassat, D.; Brochet, B.; Confavreux, C.; Edan, G.; Farkkila, M.; Fredrikson, S.; Frontoni, M.; D'Hooghe, M.; Hutchinson, M.; De Keyser, J.; Kieseier, B. C.; Kuempfel, T.; Rio, J.; Polman, C.; Roullet, E.; Stolz, C.; Vass, K.; Wandinger, K. P.; Kappos, L.
Objectives: To explore long-term effects of treatment and prognostic relevance of variables assessed at baseline and during the European secondary progressive multiple sclerosis (SPMS) trial of interferon beta 1b (IFNB-1b). Methods: We assessed 362 patients (60% female; median age 41 years; Expanded
Janse, M. J.; Malik, M.; Camm, A. J.; Julian, D. G.; Frangin, G. A.; Schwartz, P. J.
To perform a retrospective analysis of subgroups of patients enrolled into the European Myocardial Infarct Amiodarone Trial (EMIAT) in order to identify patients who might benefit from prophylactic amiodarone treatment and patients in whom amiodarone might be harmful. Baseline characteristics of the
Depressed heart rate variability identifies postinfarction patients who might benefit from prophylactic treatment with amiodarone: a substudy of EMIAT (The European Myocardial Infarct Amiodarone Trial)
Malik, M.; Camm, A. J.; Janse, M. J.; Julian, D. G.; Frangin, G. A.; Schwartz, P. J.
This substudy tested a prospective hypothesis that European Myocardial Infarct Amiodarone Trial (EMIAT) patients with depressed heart rate variability (HRV) benefit from amiodarone treatment. The EMIAT randomized 1,486 survivors of acute myocardial infarction (MI) aged < or =75 years with left
SPEER, CP; ROBERTSON, B; CURSTEDT, T; HALLIDAY, HL; COMPAGNONE, D; GEFELLER, O; HARMS, K; HERTING, E; MCCLURE, G; REID, M; TUBMAN, R; HERIN, P; NOACK, G; KOK, J; KOPPE, J; VANSONDEREN, L; LAUFKOTTER, E; KOHLER, W; BOENISCH, H; ALBRECHT, K; HANSSLER, L; HAIM, M; OETOMO, SB; Okken, Albert; ALTFELD, PC; GRONECK, P; KACHEL, W; RELIER, JP; WALTI, H
There is now convincing evidence that the severity of neonatal respiratory distress syndrome can be reduced by surfactant replacement therapy; however, the optimal therapeutic regimen has not been defined. This randomized European multicenter trial was designed to determine whether the beneficial
Schirmer, S. H.; van der Laan, A. M.; Böhm, M.; Mahfoud, F.
This summary article provides an update on novel clinical trials in the field of cardiovascular (CV) medicine which were presented at the annual meeting of the European Cardiac Society, held in Barcelona, Spain, in August-September 2009. The data were presented by leading experts in the field with
Eynon, Nir; Nasibulina, Emiliya S.; Banting, Lauren K.; Cieszczyk, Pawel; Maciejewska-Karlowska, Agnieszka; Sawczuk, Marek; Bondareva, Elvira A.; Shagimardanova, Roza R.; Raz, Maytal; Sharon, Yael; Williams, Alun G.; Ahmetov, Ildus I.
Objective The FTO A/T polymorphism (rs9939609) is a strong candidate to influence obesity-related traits. Elite athletes from many different sporting disciplines are characterized by low body fat. Therefore, the aim of this study was to assess whether athletic status is associated with the FTO A/T polymorphism. Subjects and Methods A large cohort of European Caucasians from Poland, Russia and Spain were tested to examine the association between FTO A/T polymorphism (rs9939609) and athletic status. A total of 551 athletes were divided by type of sport (endurance athletes, n = 266 vs. sprint/power athletes, n = 285) as well as by level of competition (elite-level vs. national-level). The control group consisted of 1,416 ethnically-matched, non-athletic participants, all Europeans. Multinomial logistic regression analyses were conducted to assess the association between FTO A/T genotypes and athletic status/competition level. Results There were no significantly greater/lesser odds of harbouring any type of genotype when comparing across athletic status (endurance athletes, sprint/power athletes or control participants). These effects were observed after controlling for sex and nationality. Furthermore, no significantly greater/lesser odds ratios were observed for any of the genotypes in respect to the level of competition (elite-level vs. national-level). Conclusion The FTO A/T polymorphism is not associated with elite athletic status in the largest group of elite athletes studied to date. Large collaborations and data sharing between researchers, as presented here, are strongly recommended to enhance the research in the field of exercise genomics. PMID:23573268
Dufresnes, Christophe; Brelsford, Alan; Crnobrnja-Isailović, Jelka; Tzankov, Nikolay; Lymberakis, Petros; Perrin, Nicolas
Hybridization between incipient species is expected to become progressively limited as their genetic divergence increases and reproductive isolation proceeds. Amphibian radiations and their secondary contact zones are useful models to infer the timeframes of speciation, but empirical data from natural systems remains extremely scarce. Here we follow this approach in the European radiation of tree frogs (Hyla arborea group). We investigated a natural hybrid zone between two lineages (Hyla arborea and Hyla orientalis) of Mio-Pliocene divergence (~5 My) for comparison with other hybrid systems from this group. We found concordant geographic distributions of nuclear and mitochondrial gene pools, and replicated narrow transitions (~30 km) across two independent transects, indicating an advanced state of reproductive isolation and potential local barriers to dispersal. This result parallels the situation between H. arborea and H. intermedia, which share the same amount of divergence with H. orientalis. In contrast, younger lineages show much stronger admixture at secondary contacts. Our findings corroborate the negative relationship between hybridizability and divergence time in European tree frogs, where 5 My are necessary to achieve almost complete reproductive isolation. Speciation seems to progress homogeneously in this radiation, and might thus be driven by gradual genome-wide changes rather than single speciation genes. However, the timescale differs greatly from that of other well-studied amphibians. General assumptions on the time necessary for speciation based on evidence from unrelated taxa may thus be unreliable. In contrast, comparative hybrid zone analyses within single radiations such as our case study are useful to appreciate the advance of speciation in space and time.
Hardan, Antonio Y; Gengoux, Grace W; Berquist, Kari L; Libove, Robin A; Ardel, Christina M; Phillips, Jennifer; Frazier, Thomas W; Minjarez, Mendy B
With rates of autism diagnosis continuing to rise, there is an urgent need for effective and efficient service delivery models. Pivotal Response Treatment (PRT) is considered an established treatment for autism spectrum disorder (ASD); however, there have been few well-controlled studies with adequate sample size. The aim of this study was to conduct a randomized controlled trial to evaluate PRT parent training group (PRTG) for targeting language deficits in young children with ASD. Fifty-three children with autism and significant language delay between 2 and 6 years old were randomized to PRTG (N = 27) or psychoeducation group (PEG; N = 26) for 12 weeks. The PRTG taught parents behavioral techniques to facilitate language development. The PEG taught general information about ASD (clinical trial NCT01881750; http://www.clinicaltrials.gov). Analysis of child utterances during the structured laboratory observation (primary outcome) indicated that, compared with children in the PEG, children in the PRTG demonstrated greater improvement in frequency of utterances (F(2, 43) = 3.53, p = .038, d = 0.42). Results indicated that parents were able to learn PRT in a group format, as the majority of parents in the PRTG (84%) met fidelity of implementation criteria after 12 weeks. Children also demonstrated greater improvement in adaptive communication skills (Vineland-II) following PRTG and baseline Mullen visual reception scores predicted treatment response to PRTG. This is the first randomized controlled trial of group-delivered PRT and one of the largest experimental investigations of the PRT model to date. The findings suggest that specific instruction in PRT results in greater skill acquisition for both parents and children, especially in functional and adaptive communication skills. Further research in PRT is warranted to replicate the observed results and address other core ASD symptoms. © 2014 Association for Child and Adolescent Mental Health.
Maraj, Anika; Anderson, Kelly K; Flora, Nina; Ferrari, Manuela; Archie, Suzanne; McKenzie, Kwame J
To assess variability in symptom presentation and explanatory models of psychosis for people from different ethnic groups. Clients with first-episode psychosis (n = 171) who identified as black African, black Caribbean or white European were recruited from early intervention programmes in Toronto and Hamilton. We compared results by ethnic group for symptom profiles and explanatory models of illness. Clients of black Caribbean origin had a lower odds of reporting that they were speaking incomprehensibly (OR = 0.36; 95% CI: 0.14-0.90) and black African clients had a greater odds of reporting persistent aches or pains (OR = 2.92; 95% CI: 1.32-6.50). Black African clients had a lower odds of attributing the cause of psychosis to hereditary factors (OR = 0.41; 95% CI: 0.19-0.89) or to substance abuse (OR = 0.29; 95% CI: 0.13-0.67) and had a lower odds of assigning responsibility for their illness to themselves (OR = 0.41; 95% CI: 0.19-0.89). Understanding the differences in illness models for ethnic minority groups may help improve the cultural competence of mental health services. © 2015 Wiley Publishing Asia Pty Ltd.
Schilling, Clare; Stoeckli, Sandro J; Haerle, Stephan K; Broglie, Martina A; Huber, Gerhard F; Sorensen, Jens Ahm; Bakholdt, Vivi; Krogdahl, Annelise; von Buchwald, Christian; Bilde, Anders; Sebbesen, Lars R; Odell, Edward; Gurney, Benjamin; O'Doherty, Michael; de Bree, Remco; Bloemena, Elisabeth; Flach, Geke B; Villarreal, Pedro M; Fresno Forcelledo, Manuel Florentino; Junquera Gutiérrez, Luis Manuel; Amézaga, Julio Alvarez; Barbier, Luis; Santamaría-Zuazua, Joseba; Moreira, Augusto; Jacome, Manuel; Vigili, Maurizio Giovanni; Rahimi, Siavash; Tartaglione, Girolamo; Lawson, Georges; Nollevaux, Marie-Cecile; Grandi, Cesare; Donner, Davide; Bragantini, Emma; Dequanter, Didier; Lothaire, Philippe; Poli, Tito; Silini, Enrico M; Sesenna, Erinco; Dolivet, Giles; Mastronicola, Romina; Leroux, Agnes; Sassoon, Isabel; Sloan, Philip; McGurk, Mark
Optimum management of the N0 neck is unresolved in oral cancer. Sentinel node biopsy (SNB) can reliably detect microscopic lymph node metastasis. The object of this study was to establish whether the technique was both reliable in staging the N0 neck and a safe oncological procedure in patients with early-stage oral squamous cell carcinoma. An European Organisation for Research and Treatment of Cancer-approved prospective, observational study commenced in 2005. Fourteen European centres recruited 415 patients with radiologically staged T1-T2N0 squamous cell carcinoma. SNB was undertaken with an average of 3.2 nodes removed per patient. Patients were excluded if the sentinel node (SN) could not be identified. A positive SN led to a neck dissection within 3 weeks. Analysis was performed at 3-year follow-up. An SN was found in 99.5% of cases. Positive SNs were found in 23% (94 in 415). A false-negative result occurred in 14% (15 in 109) of patients, of whom eight were subsequently rescued by salvage therapy. Recurrence after a positive SNB and subsequent neck dissection occurred in 22 patients, of which 16 (73%) were in the neck and just six patients were rescued. Only minor complications (3%) were reported following SNB. Disease-specific survival was 94%. The sensitivity of SNB was 86% and the negative predictive value 95%. These data show that SNB is a reliable and safe oncological technique for staging the clinically N0 neck in patients with T1 and T2 oral cancer. EORTC Protocol 24021: Sentinel Node Biopsy in the Management of Oral and Oropharyngeal Squamous Cell Carcinoma. Copyright © 2015. Published by Elsevier Ltd.
Crawford, Mike J; Killaspy, Helen; Barnes, Thomas R E; Barrett, Barbara; Byford, Sarah; Clayton, Katie; Dinsmore, John; Floyd, Siobhan; Hoadley, Angela; Johnson, Tony; Kalaitzaki, Eleftheria; King, Michael; Leurent, Baptiste; Maratos, Anna; O'Neill, Francis A; Osborn, David P; Patterson, Sue; Soteriou, Tony; Tyrer, Peter; Waller, Diane
To evaluate the clinical effectiveness of group art therapy for people with schizophrenia and to test whether any benefits exceed those of an active control treatment. Three arm, rater blinded, pragmatic, randomised controlled trial. Secondary care services across 15 sites in the United Kingdom. 417 people aged 18 or over, who had a diagnosis of schizophrenia and provided written informed consent to take part in the study. Participants, stratified by site, were randomised to 12 months of weekly group art therapy plus standard care, 12 months of weekly activity groups plus standard care, or standard care alone. Art therapy and activity groups had up to eight members and lasted for 90 minutes. In art therapy, members were given access to a range of art materials and encouraged to use these to express themselves freely. Members of activity groups were offered various activities that did not involve use of art or craft materials and were encouraged to collectively select those they wanted to pursue. The primary outcomes were global functioning, measured using the global assessment of functioning scale, and mental health symptoms, measured using the positive and negative syndrome scale, 24 months after randomisation. Main secondary outcomes were levels of group attendance, social functioning, and satisfaction with care at 12 and 24 months. 417 participants were assigned to either art therapy (n=140), activity groups (n=140), or standard care alone (n=137). Primary outcomes between the three study arms did not differ. The adjusted mean difference between art therapy and standard care at 24 months on the global assessment of functioning scale was -0.9 (95% confidence interval -3.8 to 2.1), and on the positive and negative syndrome scale was 0.7 (-3.1 to 4.6). Secondary outcomes did not differ between those referred to art therapy or those referred to standard care at 12 or 24 months. Referring people with established schizophrenia to group art therapy as delivered in this
Crawford, M J; Killaspy, H; Barnes, T R; Barrett, B; Byford, S; Clayton, K; Dinsmore, J; Floyd, S; Hoadley, A; Johnson, T; Kalaitzaki, E; King, M; Leurent, B; Maratos, A; O'Neill, F A; Osborn, D; Patterson, S; Soteriou, T; Tyrer, P; Waller, D
To examine the clinical effectiveness and cost-effectiveness of referral to group art therapy plus standard care, compared with referral to an activity group plus standard care and standard care alone, among people with schizophrenia. A three-arm, parallel group, single-blind, pragmatic, randomised controlled trial. Participants were randomised via an independent and remote telephone randomisation service using permuted blocks, stratified by study centre. Study participants were recruited from secondary care mental health and social services in four UK centres. Potential participants were aged 18 years or over, had a clinical diagnosis of schizophrenia, confirmed by an examination of case notes, and provided written informed consent. We excluded those who were unable to speak sufficient English to complete the baseline assessment, those with severe cognitive impairment and those already receiving arts therapy. Group art therapy was delivered by registered art therapists according to nationally agreed standards. Groups had up to eight members, lasted for 90 minutes and ran for 12 months. Members were given access to a range of art materials and encouraged to use these to express themselves freely. Activity groups were designed to control for the non-specific effects of group art therapy. Group facilitators offered various activities and encouraged participants to collectively select those they wanted to pursue. Standard care involved follow-up from secondary care mental health services and the option of referral to other services, except arts therapies, as required. Our co-primary outcomes were global functioning (measured using the Global Assessment of Functioning Scale - GAF) and mental health symptoms (measured using the Positive and Negative Syndrome Scale - PANSS) at 24 months. The main secondary outcomes were level of group attendance, social functioning, well-being, health-related quality of life, service utilisation and other costs measured 12 and 24 months
Mørkved, Siv; Salvesen, Kjell Asmund; Schei, Berit; Lydersen, Stian; Bø, Kari
Prevention of lumbopelvic pain in pregnancy has been sparsely studied. One aim of this study was to assess if a 12-week training program during pregnancy can prevent and/or treat lumbopelvic pain. A randomized controlled trial was conducted at Trondheim University Hospital and three outpatient physiotherapy clinics. Three hundred and one healthy nulliparous women were included at 20 weeks of pregnancy and randomly allocated to a training group (148) or a control group (153). The outcome measures were self-reported symptoms of lumbopelvic pain (once per week or more), sick leave, and functional status. Pain drawing was used to document the painful area of the body. The intervention included daily pelvic floor muscle training at home, and weekly group training over 12 weeks including aerobic exercises, pelvic floor muscle and additional exercises, and information related to pregnancy. At 36 weeks of gestation women in the training group were significantly less likely to report lumbopelvic pain: 65/148 (44%) versus 86/153 (56%) (p=0.03). Three months after delivery the difference was 39/148 (26%) in the training group versus 56/153 (37%) in the control group (p=0.06). There was no difference in sick leave during pregnancy, but women in the training group had significantly (p=0.01) higher scores on functional status. A 12-week specially designed training program during pregnancy was effective in preventing lumbopelvic pain in pregnancy.
Full Text Available Informed consent forms (ICFs for oncology clinical trials have grown increasingly longer and more complex. We evaluated objective understanding of critical components of informed consent among patients enrolling in contemporary trials of conventional or novel biologic/targeted therapies.We evaluated ICFs for cancer clinical trials for length and readability, and patients registered on those studies were asked to complete a validated 14-question survey assessing their understanding of key characteristics of the trial. Mean scores were compared in groups defined by trial and patient characteristics.Fifty patients, of whom half participated in trials of immunotherapy or biologic/targeted agents and half in trials of conventional therapy, completed the survey. On average, ICFs for industry-originated trials (N = 9 trials were significantly longer (P < .0001 and had lower Flesch ease-of-reading scores (P = .003 than investigator-initiated trials (N = 11. At least 80% of patients incorrectly responded to three key questions which addressed the experimental nature of their trial therapy, its purported efficacy and potential risks relative to alternative treatments. The mean objective understanding score was 76.9±8.8, but it was statistically significantly lower for patients who had not completed high school (P = .011. The scores did not differ significantly by type of cancer therapy (P = .12 or trial sponsor (P = .38.Many participants enrolled on cancer trials had poor understanding of essential elements of their trial. In order to ensure true informed consent, innovative approaches, such as expanded in-person counseling adapted to the patient's education level or cultural characteristics should be evaluated across socio-demographic groups.Clinicaltrials.gov NCT01772511.
Conway, Gerard; Dewailly, Didier; Diamanti-Kandarakis, Evanthia; Escobar-Morreale, Hector F; Franks, Steven; Gambineri, Alessandra; Kelestimur, Fahrettin; Macut, Djuro; Micic, Dragan; Pasquali, Renato; Pfeifer, Marija; Pignatelli, Duarte; Pugeat, Michel; Yildiz, Bulent
There is evidence for differences between endocrinologists and other specialists in their approach to diagnosis and management of the polycystic ovary syndrome (PCOS). A mailed survey consisting of a simple questionnaire aiming to understand current practice for diagnosis and management of the PCOS by specialists across Europe. The questionnaire consisted of 23 questions grouped to achieve information on i) the general characteristics of the respondents, ii) patients with PCOS seen by endocrinologists, iii) the main diagnostic criteria, iv) biochemical parameters used in the differential diagnosis of hyperandrogenism, v) long-term concerns, and, finally vi) treatment choices. A total of 357 questionnaires representing 13.3% of the members of European Society of Endocrinology (ESE) were available for final analysis; 93% of the respondents were endocrinologists In relation to the diagnostic criteria, respondents were most likely to select menstrual irregularity as the most frequent criteria used for the diagnosis of PCOS although very high rates were achieved for the use of hirsutism and biochemical hyperandrogenism. It therefore appears that the NIH criteria were followed by the majority of respondents. The most frequent biochemical parameters in the differential diagnosis of hyperandrogenism were total testosterone or free androgen index. Obesity and type 2 diabetes were regarded as the principal long-term concerns for PCOS. The most common treatments for patients with PCOS were metformin (33%), lifestyle modification (25%), and oral contraceptives (22%). More direct treatments of infertility include clomiphene citrate alone or in combination with metformin, prescribed by 9 and 23%, respectively, whereas only 6% used other methods for induction of ovulation. The survey produced by ESE is a good start for evaluating the perspective in the diagnosis and treatment of PCOS by endocrinologists in Europe. © 2014 European Society of Endocrinology.
Bahat, Gulistan; Tufan, Asli; Tufan, Fatih; Kilic, Cihan; Akpinar, Timur Selçuk; Kose, Murat; Erten, Nilgun; Karan, Mehmet Akif; Cruz-Jentoft, Alfonso J
The reported prevalence of sarcopenia ranges widely depending on its definition criterion. European Working Group on Sarcopenia in Older People (EWGSOP) developed a practical clinical definition and consensus diagnostic criteria. This definition recommends using normative data of the study population rather than other reference populations. We aimed to define the reference cut-off values for muscle mass, muscle strength and calf circumference in Turkey in order to improve general applicability of EWGSOP criteria. Healthy young adults between 18 and 39 years of age with no known chronic disease or chronic drug usage were included in our study to serve as reference population for assessing muscle mass. Community-dwelling older outpatients were prospectively recruited from the geriatrics outpatient clinics of a university hospital for assessing hand grip strength and calf circumference. Body composition was assessed by bioimpedance analysis. Muscle strength was assessed measuring hand grip strength with a Jamar hand dynamometer. The cut-off thresholds for muscle mass were defined as the mean-2SD of the values of the young reference study population; for grip strength were calculated from ROC analyses using cut-off values that predicted gait speed < 0.8 m/s; and for calf circumference were calculated from ROC analyses using cut-off values that predicted low muscle mass. The young reference group included a total of 301 participants (187 male, 114 female; mean age: 26.5 ± 4.6 years). The cut-off thresholds for skeletal muscle mass indexes were 9.2 kg/m(2) and 7.4 kg/m(2) in males and females, respectively. The older community dwelling group included 406 subjects (123 male, 283 female, mean age: 76.6 ± 6.7 years). The cut-off thresholds for hand grip strength were 32 kg and 22 kg for males and females. The cut-off threshold for calf circumference was 33 cm for both males and females. The cut-off thresholds for muscle mass, grip strength and calf
Predictors of weight loss and maintenance during 2 years of treatment by sibutramine in obesity. Results from the European multi-centre STORM trial. Sibutramine Trial of Obesity Reduction and Maintenance
Hansen, D; Astrup, A; Toubro, S
In this report we assess pre-treatment determinants of weight loss and maintenance outcome in The Sibutramine Trial of Obesity Reduction and Maintenance (STORM), a 2 y randomized, double-blind, placebo-controlled, European multicenter study examining the effect of sibutramine (Sib) on inducing...... and maintaining weight loss in obese subjects....
Soorya, Latha V; Siper, Paige M; Beck, Todd; Soffes, Sarah; Halpern, Danielle; Gorenstein, Michelle; Kolevzon, Alexander; Buxbaum, Joseph; Wang, A Ting
This study evaluated the efficacy of a targeted social skills training group in school-aged children with autism spectrum disorder (ASD). The intervention, Seaver-NETT (Nonverbal communication, Emotion recognition, and Theory of mind Training), is a 12-session cognitive-behavioral intervention (CBI) for verbal, school-aged children targeting ASD-specific social behavioral impairments. Sixty-nine children with ASD, 8 to 11 years of age, with verbal IQs greater than 70, participated in a randomized comparative trial to examine the efficacy of NETT relative to a facilitated play group. Treatment outcomes included caregiver reports of social behavior and neuropsychological assessments of social cognition conducted by blinded raters. Outcomes were collected at baseline, endpoint, and 3 months posttreatment. Significant improvements were found on social behavior outcomes such as nonverbal communication, empathic responding, and social relations in the NETT condition relative to the active control at endpoint. Verbal IQ moderated the interaction effect on social behavior, with higher verbal IQ associated with improvements in the CBI condition. No significant improvements were found on social cognitive outcomes. No significant group differences were found at 3-month follow-up conducted with approximately half the sample (n = 34). These data indicate that targeted CBI social skills groups such as NETT improve social communication deficits in verbal, school-aged children with ASD. The moderating effects of high verbal IQ suggest a need to consider participant and treatment characteristics associated with outcomes in future studies. Clinical trial registration information-Neural and Behavioral Outcomes of Social Skills Groups in Children With Autism Spectrum Disorder; https://clinicaltrials.gov; NCT01190917. Copyright © 2015 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.
Vasen, Hans F A; Blanco, Ignacio; Aktan-Collan, Katja; Gopie, Jessica P; Alonso, Angel; Aretz, Stefan; Bernstein, Inge; Bertario, Lucio; Burn, John; Capella, Gabriel; Colas, Chrystelle; Engel, Christoph; Frayling, Ian M; Genuardi, Maurizio; Heinimann, Karl; Hes, Frederik J; Hodgson, Shirley V; Karagiannis, John A; Lalloo, Fiona; Lindblom, Annika; Mecklin, Jukka-Pekka; Møller, Pal; Myrhoj, Torben; Nagengast, Fokko M; Parc, Yann; Ponz de Leon, Maurizio; Renkonen-Sinisalo, Laura; Sampson, Julian R; Stormorken, Astrid; Sijmons, Rolf H; Tejpar, Sabine; Thomas, Huw J W; Rahner, Nils; Wijnen, Juul T; Järvinen, Heikki Juhani; Möslein, Gabriela
Lynch syndrome (LS) is characterised by the development of colorectal cancer, endometrial cancer and various other cancers, and is caused by a mutation in one of the mismatch repair genes: MLH1, MSH2, MSH6 or PMS2. In 2007, a group of European experts (the Mallorca group) published guidelines for the clinical management of LS. Since then substantial new information has become available necessitating an update of the guidelines. In 2011 and 2012 workshops were organised in Palma de Mallorca. A total of 35 specialists from 13 countries participated in the meetings. The first step was to formulate important clinical questions. Then a systematic literature search was performed using the Pubmed database and manual searches of relevant articles. During the workshops the outcome of the literature search was discussed in detail. The guidelines described in this paper may be helpful for the appropriate management of families with LS. Prospective controlled studies should be undertaken to improve further the care of these families.
Vasen, Hans F A; Blanco, Ignacio; Aktan-Collan, Katja; Gopie, Jessica P; Alonso, Angel; Aretz, Stefan; Bernstein, Inge; Bertario, Lucio; Burn, John; Capella, Gabriel; Colas, Chrystelle; Engel, Christoph; Frayling, Ian M; Genuardi, Maurizio; Heinimann, Karl; Hes, Frederik J; Hodgson, Shirley V; Karagiannis, John A; Lalloo, Fiona; Lindblom, Annika; Mecklin, Jukka-Pekka; Møller, Pal; Myrhoj, Torben; Nagengast, Fokko M; Parc, Yann; Ponz de Leon, Maurizio; Renkonen-Sinisalo, Laura; Sampson, Julian R; Stormorken, Astrid; Sijmons, Rolf H; Tejpar, Sabine; Thomas, Huw J W; Rahner, Nils; Wijnen, Juul T; Järvinen, Heikki Juhani; Möslein, Gabriela
Lynch syndrome (LS) is characterised by the development of colorectal cancer, endometrial cancer and various other cancers, and is caused by a mutation in one of the mismatch repair genes: MLH1, MSH2, MSH6 or PMS2. In 2007, a group of European experts (the Mallorca group) published guidelines for the clinical management of LS. Since then substantial new information has become available necessitating an update of the guidelines. In 2011 and 2012 workshops were organised in Palma de Mallorca. A total of 35 specialists from 13 countries participated in the meetings. The first step was to formulate important clinical questions. Then a systematic literature search was performed using the Pubmed database and manual searches of relevant articles. During the workshops the outcome of the literature search was discussed in detail. The guidelines described in this paper may be helpful for the appropriate management of families with LS. Prospective controlled studies should be undertaken to improve further the care of these families. PMID:23408351
van der Zanden, Rianne; Kramer, Jeannet; Gerrits, Rob; Cuijpers, Pim
Depression is a serious mental health problem, whose first onset is usually in adolescence. Online treatment may offer a solution for the current undertreatment of depression in youth. For adults with depressive symptoms, the effectiveness of Internet-based cognitive behavioral therapy has been demonstrated. This study is one of the first randomized controlled trials to investigate the effectiveness online depression treatment for young people with depressive complaints and the first to focus on an online group course. To evaluate and discuss the effectiveness of a guided Web-based group course called Grip op Je Dip (Master Your Mood [MYM]), designed for young people aged 16 to 25 years with depressive symptoms, in comparison with a wait-listed control group. We randomly assigned 244 young people with depressive symptoms to the online MYM course or to a waiting-list control condition. The primary outcome measure was treatment outcome after 3 months on the Center for Epidemiologic Studies Depression Scale. Secondary outcomes were anxiety (measured by the Hospital Anxiety and Depression Scale) and mastery (Mastery Scale). We studied the maintenance of effects in the MYM group 6 months after baseline. Missing data were imputed. The MYM group (n = 121) showed significantly greater improvement in depressive symptoms at 3 months than the control group (n = 123) (t(187 )= 6.62, P limitation is the infeasibility of comparing the 6-month outcomes of the MYM and control groups, as the controls had access to MYM after 3 months. The online group course MYM was effective in reducing depressive symptoms and anxiety and in increasing mastery in young people. These effects persisted in the MYM group at 6 months.
Huang, Alison J.; Jenny, Hillary E.; Chesney, Margaret A.; Schembri, Michael; Subak, Leslee L.
Objective To examine the feasibility, efficacy, and safety of a group-based yoga therapy intervention for middle-aged and older women with urinary incontinence. Methods We conducted a pilot randomized trial of ambulatory women aged 40 years and older with stress, urgency, or mixed-type incontinence. Women were randomized to a 6-week yoga therapy program (N=10) consisting of twice weekly group classes and once weekly home practice or a waitlist control group (N=9). All participants also received written pamphlets about standard behavioral self-management strategies for incontinence. Changes in incontinence were assessed by 7-day voiding diaries. Results Mean (±SD) age was 61.4 (±8.2) years, and mean baseline frequency of incontinence was 2.5 (±1.3) episodes/day. After 6 weeks, total incontinence frequency decreased by 66% (1.8 [±0.9] fewer episodes/day) in the yoga therapy versus 13% (0.3 [±1.7] fewer episodes/day) in the control group (P=0.049). Participants in the yoga therapy group also reported an average 85% decrease in stress incontinence frequency (0.7 [±0.8] fewer episodes/day) compared to a 25% increase in controls (0.2 [± 1.1] more episodes/day) (P=0.039). No significant differences in reduction in urgency incontinence were detected between the yoga therapy versus control groups (1.0 [±1.0] versus 0.5 [±0.5] fewer episodes/day, P=0.20). All women starting the yoga therapy program completed at least 90% of group classes and practice sessions. Two participants in each group reported adverse events unrelated to the intervention. Conclusions Findings provide preliminary evidence to support the feasibility, efficacy, and safety of a group-based yoga therapy intervention to improve urinary incontinence in women. PMID:24763156
Moher, David; Hopewell, Sally; Schulz, Kenneth F
that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed...... the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major...... international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs. During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others...
Moher, David; Hopewell, Sally; Schulz, Kenneth F
that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed...... the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major...... international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs. During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others...
Capobianco, Lora; Reeves, David; Morrison, Anthony P; Wells, Adrian
Two transdiagnostic therapies for treating psychological disorder are Metacognitive Therapy (MCT) and Mindfulness Based Stress Reduction (MBSR). These two approaches have yet to be compared and therefore the current study aimed to evaluate the feasibility of a study of group MCT and MBSR in treating anxiety and depression. A feasibility trial with 40 participants (aged 19-56) was conducted. Patients were randomly assigned to receive either eight weeks of group MCT or MBSR. The primary outcome was feasibility which included recruitment rates, retention and treatment acceptability. The primary symptom outcome was the Hospital Anxiety and Depression Scale (HADS) total score, which provided an overall measure of distress. Both treatments were found to be acceptable with low attrition and similar ratings of acceptability. Changes in outcomes were analyzed based on the intention-to-treat principle using mixed effect models. Preliminary analyses revealed that MCT was more effective in treating anxiety and depression in comparison to MBSR, and in reducing both positive and negative metacognitive beliefs. Reliable improvement rates favoured MCT at post-treatment and 6-month follow up. Both treatments appeared to be feasible and acceptable in treating transdiagnostic samples; however, a larger, definitive trial is required. The limitations and directions for future research are discussed. Copyright © 2017 Elsevier B.V. All rights reserved.
van den Heuvel, Suzanne; Loeb, Stacy; Zhu, Xiaoye; Verhagen, Paul Cms; Schröder, Fritz H; Bangma, Chris H; Roobol, Monique J
Transrectal prostate needle biopsy (PNB) is a standard procedure for the diagnosis of prostate cancer. We recently found an increasing frequency of hospitalization with infectious complications associated with PNB over time. To perform an updated analysis of overall complication rates in a large screening population over the past 18 years and to examine possible predictors of complications on initial PNB. From 1993-2011, 7216 men underwent initial lateralized sextant PNB in European Randomized Study of Screening for Prostate Cancer (ERSPC) Rotterdam. After 2 weeks a questionnaire was administered to 6962 men regarding PNB-related complications. Outcome Measurements & Statistical Analysis: Overall complication rates as well as specific complications (hematuria for >3 days, hematospermia, significant pain after biopsy, fever, and hospitalizations) were prospectively recorded. Multivariable logistic regression models were performed to assess the relationship between age, comorbidities, and prostate volume with specific complications. A total of 4674 (67.1%) men reported any sequelae after initial PNB, with hematospermia as the most frequent (53.8%), followed by hematuria (24.3%). Significant pain (4.8%), fever (4.1%), and hospital admission (0.7%) were reported less frequently. Hematospermia was significantly more likely in younger men with fewer comorbidities and smaller prostate volume; whereas hematuria was significantly more frequent among men with increasing comorbidities and prostate volume. In addition, pain was inversely associated with age and was also reported less frequently during later years of biopsy. Limitations of our study include the use of sextant biopsies and a relatively healthy population, while strengths include the large sample size and data on patient-specific covariates. Many men experience minor complications after initial PNB, although the frequency of specific complications such as hematospermia and hematuria differed based upon factors
Full Text Available The aim of the study was to analyse provenance tests of beech situated close to theSoutheastern-continental limits of the species, in order to develop a response model of adaptation andplasticity of populations on evolutionary-ecological basis, following sudden climatic changes as aresult of transplanting. Modelling of juvenile height was performed with the help of ecodistancevariables. The concept of transfer analysis and ecodistance is based on the hypothesis that phenotypicresponse to macroclimatic changes depends on the inherited adaptive potential of the population andon the magnitude and direction of experienced environmental change. In common garden experiments,the transfer to the planting site is interpreted as simulation of environmental change. The applicationof ecodistance of transfer for evaluating common garden experiments provides much neededquantitative information about response of tree populations to predicted climatic changes.The analysis of three field experiments of European beech in SE Europe invalidate earlier doubtsabout the existence of macroclimatic adaptation patterns in juvenile growth and justify restrictions ofuse of reproductive material on the basis of evolutionary ecology. The presented model illustrates thatresponse to climatic change is regionally divergent, depending on testing conditions and on hereditarytraits. In particular, climatic warming in the central-northern part of the range may lead to productionincrease. However, under the stressful and uncertain conditions at the lower (xeric limit of thespecies, growth depression and vitality loss are predicted. The deviating behaviour of higher elevationprovenances support their separate treatment.The results may be utilised in climate change adaptation and mitigation policy in forestry andnature conservation, to revise rules for use of reproductive material and also for validatingevolutionary and ecological hypotheses related to climate change effects.
Ulloa, Alvaro Emilio; Chen, Jiayu; Vergara, Victor Manuel; Calhoun, Vince; Liu, Jingyu
Background Copy number variations (CNVs) are structural genetic mutations consisting of segmental gains or losses in DNA sequence. Although CNVs contribute substantially to genomic variation, few genetic and imaging studies report association of CNVs with alcohol dependence (AD). Our purpose is to find evidence of this association across ethnic populations and genders. This work is the first AD-CNV study across ethnic groups and the first to include the African American population. Methods This study considers two CNV datasets, one for discovery (2,345 samples) and the other for validation (239 samples), both including subjects with AD and healthy controls of European and African ancestry. Our analysis assesses the association between AD and CNV losses across ethnic groups and gender by examining the effect of overall losses across the whole genome, collective losses within individual cytogenetic bands and specific losses in CNV regions. Results Results from the discovery dataset showed an association between CNV losses within 16q12.2 and AD diagnosis (p = 4.53x10−3). An overlapping CNV region from the validation dataset exhibited the same direction of effect with respect to AD (p = 0.051). This CNV region affects the genes CES1p1 and CES1, which are members of the carboxylesterase (CES) family. The enzyme encoded by CES1 is a major liver enzyme that typically catalyzes the decomposition of ester into alcohol and carboxylic acid and is involved in drug or xenobiotics, fatty acid and cholesterol metabolisms. In addition, the most significantly associated CNV region was located at 9p21.2 (p = 1.9×10−3) in our discovery dataset. Although not observed in the validation dataset, probably due to small sample size, this result might hold potential connection to AD given its connection with neuronal death. In contrast, we did not find any association between AD and the overall total losses or the collective losses within individual cytogenetic bands. Conclusions
Kritz, Marlene; Gschwandtner, Manfred; Stefanov, Veronika; Hanbury, Allan
Background There is a large body of research suggesting that medical professionals have unmet information needs during their daily routines. Objective To investigate which online resources and tools different groups of European physicians use to gather medical information and to identify barriers that prevent the successful retrieval of medical information from the Internet. Methods A detailed Web-based questionnaire was sent out to approximately 15,000 physicians across Europe and disseminated through partner websites. 500 European physicians of different levels of academic qualification and medical specialization were included in the analysis. Self-reported frequency of use of different types of online resources, perceived importance of search tools, and perceived search barriers were measured. Comparisons were made across different levels of qualification (qualified physicians vs physicians in training, medical specialists without professorships vs medical professors) and specialization (general practitioners vs specialists). Results Most participants were Internet-savvy, came from Austria (43%, 190/440) and Switzerland (31%, 137/440), were above 50 years old (56%, 239/430), stated high levels of medical work experience, had regular patient contact and were employed in nonacademic health care settings (41%, 177/432). All groups reported frequent use of general search engines and cited “restricted accessibility to good quality information” as a dominant barrier to finding medical information on the Internet. Physicians in training reported the most frequent use of Wikipedia (56%, 31/55). Specialists were more likely than general practitioners to use medical research databases (68%, 185/274 vs 27%, 24/88; χ2 2=44.905, Pinformation on the Internet (59%, 50/85 vs 43%, 111/260; χ2 1=7.231, P=.007) and to restrict their search by language (48%, 43/89 vs 35%, 97/278; χ2 1=5.148, P=.023). They frequently consult general health websites (36%, 31/87 vs 19%, 51
Kritz, Marlene; Gschwandtner, Manfred; Stefanov, Veronika; Hanbury, Allan; Samwald, Matthias
There is a large body of research suggesting that medical professionals have unmet information needs during their daily routines. To investigate which online resources and tools different groups of European physicians use to gather medical information and to identify barriers that prevent the successful retrieval of medical information from the Internet. A detailed Web-based questionnaire was sent out to approximately 15,000 physicians across Europe and disseminated through partner websites. 500 European physicians of different levels of academic qualification and medical specialization were included in the analysis. Self-reported frequency of use of different types of online resources, perceived importance of search tools, and perceived search barriers were measured. Comparisons were made across different levels of qualification (qualified physicians vs physicians in training, medical specialists without professorships vs medical professors) and specialization (general practitioners vs specialists). Most participants were Internet-savvy, came from Austria (43%, 190/440) and Switzerland (31%, 137/440), were above 50 years old (56%, 239/430), stated high levels of medical work experience, had regular patient contact and were employed in nonacademic health care settings (41%, 177/432). All groups reported frequent use of general search engines and cited "restricted accessibility to good quality information" as a dominant barrier to finding medical information on the Internet. Physicians in training reported the most frequent use of Wikipedia (56%, 31/55). Specialists were more likely than general practitioners to use medical research databases (68%, 185/274 vs 27%, 24/88; χ²₂=44.905, PInternet (59%, 50/85 vs 43%, 111/260; χ²₁=7.231, P=.007) and to restrict their search by language (48%, 43/89 vs 35%, 97/278; χ²₁=5.148, P=.023). They frequently consult general health websites (36%, 31/87 vs 19%, 51/269; χ²₂=12.813, P=.002) and online physician network
Frost, Randy O; Ruby, Dylan; Shuer, Lee J
Hoarding is a serious form of psychopathology that has been associated with significant health and safety concerns, as well as the source of social and economic burden (Tolin, Frost, Steketee, & Fitch, 2008; Tolin, Frost, Steketee, Gray, & Fitch, 2008). Recent developments in the treatment of hoarding have met with some success for both individual and group treatments. Nevertheless, the cost and limited accessibility of these treatments leave many hoarding sufferers without options for help. One alternative is support groups that require relatively few resources. Frost, Pekareva-Kochergina, and Maxner (2011) reported significant declines in hoarding symptoms following a non-professionally run 13-week support group (The Buried in Treasures [BIT] Workshop). The BIT Workshop is a highly structured and short term support group. The present study extended these findings by reporting on the results of a waitlist control trial of the BIT Workshop. Significant declines in all hoarding symptom measures were observed compared to a waitlist control. The treatment response rate for the BIT Workshop was similar to that obtained by previous individual and group treatment studies, despite its shorter length and lack of a trained therapist. The BIT Workshop may be an effective adjunct to cognitive behavior therapy for hoarding disorder, or an alternative when cognitive behavior therapy is inaccessible. Copyright © 2012 Elsevier Ltd. All rights reserved.
Background Gestational diabetes mellitus (GDM) is an increasing problem world-wide. Lifestyle interventions and/or vitamin D supplementation might help prevent GDM in some women. Methods/design Pregnant women at risk of GDM (BMI≥29 (kg/m2)) from 9 European countries will be invited to participate and consent obtained before 19+6 weeks of gestation. After giving informed consent, women without GDM will be included (based on IADPSG criteria: fasting glucosephysical activity (PA), 3) HE+PA, 4) control, 5) HE+PA+vitamin D, 6) HE+PA+placebo, 7) vitamin D alone, 8) placebo alone), pre-stratified for each site. In total, 880 women will be included with 110 women allocated to each arm. Between entry and 35 weeks of gestation, women allocated to a lifestyle intervention will receive 5 face-to-face, and 4 telephone coaching sessions, based on the principles of motivational interviewing. The lifestyle intervention includes a discussion about the risks of GDM, a weight gain target physical activity ‘messages’ depending on randomization. Fidelity is monitored by the use of a personal digital assistance (PDA) system. Participants randomized to the vitamin D intervention receive either 1600 IU vitamin D or placebo for daily intake until delivery. Data is collected at baseline measurement, at 24–28 weeks, 35–37 weeks of gestation and after delivery. Primary outcome measures are gestational weight gain, fasting glucose and insulin sensitivity, with a range of obstetric secondary outcome measures including birth weight. Discussion DALI is a unique Europe-wide randomised controlled trial, which will gain insight into preventive measures against the development of GDM in overweight and obese women. Trial registration ISRCTN70595832 PMID:23829946
Rigter, Henk; Henderson, Craig E; Pelc, Isidore; Tossmann, Peter; Phan, Olivier; Hendriks, Vincent; Schaub, Michael; Rowe, Cindy L
Noticing a lack of evidence-based programmes for treating adolescents heavily using cannabis in Europe, government representatives from Belgium, France, Germany, The Netherlands, and Switzerland decided to have U.S.-developed multidimensional family therapy (MDFT) tested in their countries in a trans-national trial, called the International Need for Cannabis Treatment (INCANT) study. INCANT was a 2 (treatment condition)×5 (time) repeated measures intent-to-treat randomised effectiveness trial comparing MDFT to Individual Psychotherapy (IP). Data were gathered at baseline and 3, 6, 9 and 12 months thereafter. Study participants were recruited at outpatient secondary level addiction, youth, and forensic care clinics in Brussels, Berlin, Paris, The Hague, and Geneva. Participants were adolescents from 13 through 18 years of age with a recent cannabis use disorder. 85% were boys; 40% were of foreign descent. One-third had been arrested for a criminal offence in the past 3 months. Three primary outcomes were assessed: (1) treatment retention, (2) prevalence of cannabis use disorder and (3) 90-day frequency of cannabis consumption. Positive outcomes were found in both the MDFT and IP conditions. MDFT outperformed IP on the measures of treatment retention (pcannabis dependence (p=0.015). MDFT reduced the number of cannabis consumption days more than IP in a subgroup of adolescents reporting more frequent cannabis use (p=0.002). Cannabis use disorder was responsive to treatment. MDFT exceeded IP in decreasing the prevalence of cannabis dependence. MDFT is applicable in Western European outpatient settings, and may show moderately greater benefits than IP in youth with more severe substance use. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.
Full Text Available In this study, the variability of physiological parameters of five provenances of Europeanbeech (Fagus sylvatica, which were planted at two locations with different ecological conditions atFruška Gora and Debeli Lug, was estimated. Provenance trials were established in the framework ofCOST Action E52: "Evaluation of Beech Genetic Resources for Sustainable Forestry". 2-3 years oldseedlings originating from Croatia, Germany, Bosnia, Austria and Serbia were planted in blocks offifty plants with a spacing of 2 x 1 m. Physiological parameters such as net photosynthesis, rate oftranspiration and stomatal conductance were measured with a portable gas analysis system. Generally,provenances from Fruška Gora Mountain showed higher intensity of all physiological parameters thanprovenances located at site Debeli Lug. High correlations among rates of net photosynthesis andtranspiration, on one side, and stomatal conductance, on the other side, were found. ANOVA testindicates that variability of net photosynthesis, transpiration and stomatal conductance of investigatedprovenances, at the two locations, was influenced both by environmental conditions of sites andgenetic constitution of provenances.
Tessitore, Nicola; Santoro, Antonio; Panzetta, Giovanni Oliviero; Wizemann, Volker; Perez-Garcia, Rafael; Martinez Ara, Jorge; Perrone, Bruno; Mantovani, William; Poli, Albino
Intradialytic hypotension (IH) is a common complication of bicarbonate hemodialysis (BD) and contributes to the intolerance of dialysis and the high cardiovascular morbidity and mortality among dialysis patients, the risk of which can be contained by convective therapies. To assess whether acetate-free biofiltration (AFB), a hemodiafiltration technique found to improve intradialytic cardiovascular stability in short-term studies, can influence long-term IH rates, predialysis systolic blood pressure (SBP), cardiovascular morbidity and mortality by comparison with BD, we analyzed data from a randomized controlled trial enrolling 371 new-to-dialysis patients, 194 on BD and 177 on AFB. During a 3-year follow-up, AFB carried a significantly lower risk of IH (incidence rate ratio 0.60 (95% CI 0.53-0.68), p < 0.0001). SBP dropped on AFB (p = 0.01), while it did not change on BD. Cardiovascular morbidity and mortality were similar between AFB and BD. AFB carries a lower long-term IH rate and reduces SBP by comparison with BD. Copyright © 2013 S. Karger AG, Basel.
Meaume, S; Dissemond, J; Addala, A; Vanscheidt, W; Stücker, M; Goerge, T; Perceau, G; Chahim, M; Wicks, G; Perez, J; Tacca, O; Bohbot, S
To evaluate the performance (efficacy, safety and acceptability) of a new micro-adherent absorbent dressing (UrgoClean®) compared with a hydrofiber dressing (Aquacel®) in the local management of venous leg ulcers, in the debridement stage. A non-inferiority European randomised controlled clinical trial (RCT) was conducted in 37 centres, on patients presenting with venous or predominantly venous, mixed aetiology leg ulcers at their sloughy stage (with more than 70% of the wound bed covered with slough at baseline). Patients were followed over a 6-week period and assessed weekly. The primary judgement criteria was the relative regression of the wound surface area after the 6-week treatment period. Secondary endpoints were the relative reduction of sloughy tissue and the percentage of patients presenting with a debrided wound. Altogether, 159 patients were randomised to either UrgoClean (test group; n=83) or Aquacel (control group; n=76) dressings. Regarding the wound healing process predictive factors (wound area, duration, ABPI value, recurrence), at baseline, the two groups were well balanced, for both wound and patient characteristics. Compression therapy was administered to both groups and after a median 42-day treatment period, the percentage of relative reduction of the wound surface area was very similar (-36.9% vs -35.4% in the UrgoClean and control groups, respectively). When considering the secondary criteria at week 6, the relative reduction of sloughy tissue was significantly higher in the UrgoClean group than in the control group (-65.3% vs -42,6%; p=0.013). The percentage of debrided wounds was also significantly higher in the test group (52.5% vs 35.1%; p=0.033). This 'EARTH' RCT confirmed that the UrgoClean dressing has similar efficacy and safety compared to Aquacel. However, UrgoClean also showed better autolytic properties than the control group in the management of venous leg ulcers at the sloughy stage. The new UrgoClean dressing therefore
Iliffe, S.; De Lepeleire, J.; van Hout, H.P.J.; Kenny, G.; Lewis, A.; Vernooij-Dassen, M.J.F.J.
Experts from eight European countries (Belgium, France, The Netherlands, Ireland, Italy, Portugal, Spain and the United Kingdom) and the disciplines of clinical psychology, general practice, geriatric medicine, old age psychiatry, medical sociology, nursing and voluntary body organisation met in
Milliez, Paul; Leenhardt, Antoine; Maisonblanche, Pierre; Vicaut, Eric; Badilini, Fabio; Siliste, Calin; Benchetrit, Chemia; Coumel, Philippe
The European Myocardial Infarct Amiodarone Trial (EMIAT) investigated the effects of amiodarone versus placebo in patients after myocardial infarction who had left ventricular ejection fraction death from their matched survivors in this EMIAT population. In addition, we assessed whether VR dynamicity could differentiate patients who died from arrhythmic cardiac death (ACD) and from non-ACD. VR dynamicity (determined from Holter's recordings at baseline) was compared before antiarrhythmic therapy in 118 patients who had cardiac death and 118 matched survivors according to age, gender, left ventricular ejection fraction, and subsequent administration or nonadministration of amiodarone. VR dynamicity was compared within the cardiac death group between the 59 patients who died from ACD and the 59 who died from non-ACD. VR dynamicity was expressed as the slope of the linear regression between QTo (measured automatically) and stable RR intervals. Patients who died were found to have a significant steeper rate dependence of QTo intervals during the 3 periods than their matched survivors. In multivariate analysis, the QTo/RR nocturnal interval appeared to be the best independent predictor of cardiac death. In addition, patients who died from ACD were found to have a significant steeper rate dependence of QTo intervals during the morning period than those who died from non-ACD. In the multivariate analysis, the QTo/RR morning interval remained the best independent predictor of ACD. Thus, in the EMIAT trial, evaluation of QT dynamicity is a strong predictor of cardiac death. In addition, QT dynamicity could predict the occurrence of ACD in cases of cardiac death.
Campo Osaba Maria-Antonia
responsibility for his/her own health. The rhythm of a weekly session during 8 weeks with recommended activities to put into practice, as well as the support of the group is an opportunity to incorporate healthy habits and make a commitment to self-care. The sheets handed out are a Health Manual that can always be consulted after the workshop ends. Trial registration Clinical Trials.gov Identifier: NCT01440738
Allen, Kelli D; Bongiorni, Dennis; Bosworth, Hayden B; Coffman, Cynthia J; Datta, Santanu K; Edelman, David; Hall, Katherine S; Lindquist, Jennifer H; Oddone, Eugene Z; Hoenig, Helen
Efficient approaches are needed for delivering nonpharmacological interventions for management of knee osteoarthritis (OA). This trial compared group-based versus individual physical therapy interventions for management of knee OA. Three hundred twenty patients with knee OA at the VA Medical Center in Durham, North Carolina, (mean age=60 years, 88% male, 58% nonwhite) were randomly assigned to receive either the group intervention (group physical therapy; six 1-hour sessions, typically 8 participants per group) or the individual intervention (individual physical therapy; two 1-hour sessions). Both programs included instruction in home exercise, joint protection techniques, and individual physical therapist evaluation. The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; range=0-96, higher scores indicate worse symptoms), measured at baseline, 12 weeks, and 24 weeks. The secondary outcome measure was the Short Physical Performance Battery (SPPB; range=0-12, higher scores indicate better performance), measured at baseline and 12 weeks. Linear mixed models assessed the difference in WOMAC scores between arms. At 12 weeks, WOMAC scores were 2.7 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% confidence interval [CI]=-5.9, 0.5; P=.10), indicating no between-group difference. At 24 weeks, WOMAC scores were 1.3 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% CI=-4.6, 2.0; P=.44), indicating no significant between-group difference. At 12 weeks, SPPB scores were 0.1 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% CI=-0.5, 0.2; P=.53), indicating no difference between groups. This study was conducted in one VA medical center. Outcome assessors were blinded, but participants and physical therapists were not blinded. Group physical therapy was not more effective
Creticos, Peter S; Maloney, Jennifer; Bernstein, David I; Casale, Thomas; Kaur, Amarjot; Fisher, Robert; Liu, Nancy; Murphy, Kevin; Nékám, Kristóf; Nolte, Hendrik
In North America and Europe, millions of patients experience symptoms of allergic rhinitis with or without conjunctivitis (AR/C) on exposure to ragweed pollen. The disease burden can be significant, with most patients relying on symptomatic medications without disease-modifying potential. However, novel sublingual immunomodulatory treatment options may potentially play an important role if efficacy and side effect profiles allow the convenience of self-administration. This study evaluated an allergy immunotherapy tablet (AIT; SCH 39641/MK-3641) for treatment of ragweed-induced AR/C in the first large randomized, double-blind multinational trial of this therapeutic modality for ragweed allergy. Adults (n = 784) with short ragweed-induced AR/C were randomly assigned to approximately 52 weeks of daily self-administered ragweed AIT of 1.5, 6, or 12 units of Ambrosia artemisiifolia major allergen 1 (Amb a 1-U) or placebo. Subjects could use as-needed allergy rescue medication. Symptoms and medications were recorded daily. The primary efficacy end point was total combined daily symptom/medication score (TCS) during peak ragweed season. Safety was monitored through adverse event diaries maintained through study duration. During peak ragweed season, ragweed AIT of 1.5, 6, and 12 Amb a 1-U reduced TCS by 9% (-0.76; P = .22), 19% (-1.58; P = .01), and 24% (-2.04; P = .002) compared with placebo. During the entire season, ragweed AIT of 1.5, 6, and 12 Amb a 1-U reduced TCS by 12% (-0.88; P = .09), 18% (-1.28; P = .01), and 27% (-1.92; P Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.
Grundlingh, Heidi; Knight, Louise; Naker, Dipak; Devries, Karen
Secondary distress including emotional distress, vicarious trauma (VT) and secondary traumatic stress (STS) due to exposure to primary trauma victims have been described in helping professionals and in violence researchers. To our knowledge, there are few prevalence studies, and no tailored interventions have been tested to reduce secondary distress in violence researchers. The study aims to (1) describe the epidemiology of secondary distress experienced by violence researchers; to (2) assess the effectiveness of group debriefings in mitigating secondary distress; to (3) assess risk and protective factors. We conducted an un-blinded, individually randomised trial with parallel assignment. Eligible participants were 59 Ugandan researchers employed by the Good Schools Study to interview children who experienced violence in a district of Uganda. Fifty-three researchers agreed to participate and were randomly allocated. The intervention group (n = 26) participated in three group debriefings and the control group (n = 27) in three leisure sessions (film viewings). The primary outcome was change in levels of emotional distress (SRQ-20); secondary outcomes were levels of VT and STS at end-line. A paired t-test assessed the difference in mean baseline and end-line emotional distress. Un-paired t-tests compared the change in mean emotional distress (baseline vs. end-line), and compared levels of VT and STS at end-line. Separate logistic regression models tested the association between end-line emotional distress and a-priori risk or protective factors. Baseline and end-line levels of emotional distress were similar in control (p = 0.47) and intervention (p = 0.59) groups. The superiority of group debriefing over leisure activities in lowering levels of emotional distress in the intervention group (n = 26; difference in SRQ-20 = 0.23 [SD = 2.18]) compared to the control group (n = 26; difference in SRQ-20 = 0.23 [SD = 1.63]) could not be detected (p = 1
Snowden, J A; Saccardi, R; Allez, M; Ardizzone, S; Arnold, R; Cervera, R; Denton, C; Hawkey, C; Labopin, M; Mancardi, G; Martin, R; Moore, J J; Passweg, J; Peters, C; Rabusin, M; Rovira, M; van Laar, J M; Farge, D
In 1997, the first consensus guidelines for haematopoietic SCT (HSCT) in autoimmune diseases (ADs) were published, while an international coordinated clinical programme was launched. These guidelines provided broad principles for the field over the following decade and were accompanied by comprehensive data collection in the European Group for Blood and Marrow Transplantation (EBMT) AD Registry. Subsequently, retrospective analyses and prospective phase I/II studies generated evidence to support the feasibility, safety and efficacy of HSCT in several types of severe, treatment-resistant ADs, which became the basis for larger-scale phase II and III studies. In parallel, there has also been an era of immense progress in biological therapy in ADs. The aim of this document is to provide revised and updated guidelines for both the current application and future development of HSCT in ADs in relation to the benefits, risks and health economic considerations of other modern treatments. Patient safety considerations are central to guidance on patient selection and HSCT procedural aspects within appropriately experienced and Joint Accreditation Committee of International Society for Cellular Therapy and EBMT accredited centres. A need for prospective interventional and non-interventional studies, where feasible, along with systematic data reporting, in accordance with EBMT policies and procedures, is emphasized. PMID:22002489
De Decker, E; De Craemer, M; De Bourdeaudhuij, I; Wijndaele, K; Duvinage, K; Koletzko, B; Grammatikaki, E; Iotova, V; Usheva, N; Fernández-Alvira, J M; Zych, K; Manios, Y; Cardon, G
Preschoolers already spend significant proportions of their waking hours being sedentary. Screen time (i.e. television/DVD viewing and computer use) has been negatively associated with several health outcomes but interventions aiming to reduce preschoolers' sedentary behaviour are scarce. This study aimed to explore parents' perceptions of their preschool children's screen time. One hundred twenty-two parents of low and medium-high socioeconomic status from six European countries with children between 4 and 6 years old were involved in 24 focus groups. Following a qualitative content analysis, the available information and key findings were centrally analysed. Results showed that children tend to like watching television (TV) and most parents do not express worries about their children's TV viewing time. Education is considered to be the main benefit of watching TV and in general, parents only have informal rules about TV viewing. Computer and active games use are less frequent compared with TV viewing. No univocal results are found about the influence of siblings or friends on children's screen time. Weather conditions and parental habits at home are the most important factors influencing children's screen time. Alternatives for screen activities and information on how to set rules for screen time should be provided to parents to assist them in decreasing their preschool children's screen time. © 2012 The Authors. obesity reviews © 2012 International Association for the Study of Obesity.
Cordioli Aristides V
Full Text Available Objective: To develop a cognitive-behavioral group therapy protocol and to verify its efficacy to reduce obsessive-compulsive symptoms. Methods: An open clinical trial with 32 obsessive-compulsive patients was performed, in which a cognitive-behavioral group therapy protocol of 12 weekly sessions of two hours, in 5 consecutive groups, was applied. The severity of symptoms was rated with the Yale-Brown Obsessive-Compulsive (Y-BOCS, Hamilton Anxiety (HAM A and Hamilton Depression (HAM D scales. The patients were followed up for 3 months after the end of the treatment. Results: There was a significant reduction in the scores of Y-BOCS, HAM A and HAM D scales with the treatment regardless the use of anti-obsessive medications. The rate of improved patients (decrease of > or = 35% in Y-BOCS was 78.1%. Two patients (6.25% dropped out from the study. The effect size calculated for the Y-BOCS scale was 1.75. Conclusions: This study suggests that cognitive-behavioral group therapy reduces obsessive-compulsive symptoms. In addition, patients presented good compliance.
Background Australia has an enviable record of safety for women in childbirth. There is nevertheless growing concern at the increasing level of intervention and consequent morbidity amongst childbearing women. Not only do interventions impact on the cost of services, they carry with them the potential for serious morbidities for mother and infant. Models of midwifery have proliferated in an attempt to offer women less fragmented hospital care. One of these models that is gaining widespread consumer, disciplinary and political support is caseload midwifery care. Caseload midwives manage the care of approximately 35-40 a year within a small Midwifery Group Practice (usually 4-6 midwives who plan their on call and leave within the Group Practice.) We propose to compare the outcomes and costs of caseload midwifery care compared to standard or routine hospital care through a randomised controlled trial. Methods/design A two-arm RCT design will be used. Women will be recruited from tertiary women's hospitals in Sydney and Brisbane, Australia. Women allocated to the caseload intervention will receive care from a named caseload midwife within a Midwifery Group Practice. Control women will be allocated to standard or routine hospital care. Women allocated to standard care will receive their care from hospital rostered midwives, public hospital obstetric care and community based general medical practitioner care. All midwives will collaborate with obstetricians and other health professionals as necessary according to the woman's needs. Discussion Data will be collected at recruitment, 36 weeks antenatally, six weeks and six months postpartum by web based or postal survey. With 750 women or more in each of the intervention and control arms the study is powered (based on 80% power; alpha 0.05) to detect a difference in caesarean section rates of 29.4 to 22.9%; instrumental birth rates from 11.0% to 6.8%; and rates of admission to neonatal intensive care of all neonates from 9
Giabbanelli, Philippe J; Crutzen, Rik
Controlling bias is key to successful randomized controlled trials for behaviour change. Bias can be generated at multiple points during a study, for example, when participants are allocated to different groups. Several methods of allocations exist to randomly distribute participants over the groups such that their prognostic factors (e.g., socio-demographic variables) are similar, in an effort to keep participants' outcomes comparable at baseline. Since it is challenging to create such groups when all prognostic factors are taken together, these factors are often balanced in isolation or only the ones deemed most relevant are balanced. However, the complex interactions among prognostic factors may lead to a poor estimate of behaviour, causing unbalanced groups at baseline, which may introduce accidental bias. We present a novel computational approach for allocating participants to different groups. Our approach automatically uses participants' experiences to model (the interactions among) their prognostic factors and infer how their behaviour is expected to change under a given intervention. Participants are then allocated based on their inferred behaviour rather than on selected prognostic factors. In order to assess the potential of our approach, we collected two datasets regarding the behaviour of participants (n = 430 and n = 187). The potential of the approach on larger sample sizes was examined using synthetic data. All three datasets highlighted that our approach could lead to groups with similar expected behavioural changes. The computational approach proposed here can complement existing statistical approaches when behaviours involve numerous complex relationships, and quantitative data is not readily available to model these relationships. The software implementing our approach and commonly used alternatives is provided at no charge to assist practitioners in the design of their own studies and to compare participants' allocations.
Turner, Karen M T; Richards, Mary; Sanders, Matthew R
Parenting programmes have been shown to improve children's adjustment and reduce problem behaviour; however, little research has addressed outcomes for Indigenous families. The aim of this project was to assess the impact and cultural appropriateness of a parenting programme tailored for Indigenous families, an adaptation of the evidence-based Group Triple P - Positive Parenting Program. A repeated measures randomised group design methodology was used, comparing the intervention with a waitlist control condition pre- and post-intervention, with a 6-month follow-up of the intervention group. Parents attending Group Triple P reported a significant decrease in rates of problem child behaviour and less reliance on some dysfunctional parenting practices following the intervention in comparison to waitlist families. The programme also led to greater movement from the clinical range to the non-clinic range for mean child behaviour scores on all measures. Effects were primarily maintained at 6-month follow-up. Qualitative data showed generally positive responses to the programme resources, content and process. However, only a small number of waitlist families subsequently attended groups, signalling the importance of engaging families when they first make contact, helping families deal with competing demands, and offering flexible service delivery so families can resume contact when circumstances permit. This study provides empirical support for the effectiveness and acceptability of a culturally tailored approach to Group Triple P conducted by Child Health and Indigenous Health workers in a community setting. The outcomes of this trial may be seen as a significant step in increasing appropriate service provision for Indigenous families and reducing barriers to accessing available services in the community.
Marcella Alves Mascarenhas Nardelli
Full Text Available This paper aims to define the outlines of the judicial duty to provide reasons for their decisions in its theoretical aspect - according to contemporary procedural knowledge -, as well as to establish its importance for the concretion of a fair trial. At the same time, the duty to give reasons will be analyzed in a practical perspective according to the case-law of the European Court of Human Rights, with a special emphasis in the case Taxquet v. Belgium and its impact on Jury Trials.
Sandlund, Christina; Hetta, Jerker; Nilsson, Gunnar H; Ekstedt, Mirjam; Westman, Jeanette
Insomnia is a common health problem, and most people who seek help for insomnia consult primary care. In primary care, insomnia treatment typically consists of hypnotic drugs, although cognitive behavioral therapy for insomnia is the recommended treatment. However, such treatment is currently available to few primary care patients. To evaluate the effects of a group treatment program for insomnia led by nurses in primary care. were the Insomnia Severity Index, a 2-week sleep diary, and a questionnaire on frequency of hypnotic drug use. A randomized controlled trial with pre- and post-treatment assessment and a 1-year post-treatment follow-up of the intervention group. Routine primary health care; 7 primary care centers in Stockholm, Sweden. Patients consulting primary care for insomnia were assessed for eligibility. To be included, patients had to have insomnia disorder and be 18 years or older. Patients were excluded if they if they worked night shifts or had severe untreated somatic and/or mental illness, bipolar disorder, or untreated sleep disorder other than insomnia. One-hundred and sixty-five patients 20 to 90 years were included. Most were women, and many had co-existing somatic and/or mental health problems. The post-treatment dropout rate was 20%. The intervention was a nurse-led group treatment for insomnia based on the techniques of cognitive behavioral therapy for insomnia. The nurses had 2days of training in how to deliver the program. Ninety patients were randomized to the intervention and 75 to the control group (treatment as usual). Data from 82 in the intervention and 71 in the control group were analyzed in accordance with intention-to-treat principles. Fifty-four of the 72 in the intervention group who participated in the group treatment program were followed up after 1year. Mean Insomnia Severity Index score decreased significantly from 18.4 to 10.7 after group treatment but remained unchanged after treatment as usual (17.0 to 16.6). The effect
Vinsnes, Anne G; Helbostad, Jorunn L; Nyrønning, Signe; Harkless, Gene E; Granbo, Randi; Seim, Arnfinn
Residents in nursing homes (NHs) are often frail older persons who have impaired physical activity. Urinary incontinence (UI) is a common complaint for residents in NHs. Reduced functional ability and residence in NHs are documented to be risk factors for UI. To investigate if an individualized training program designed to improve activity of daily living (ADL) and physical capacity among residents in nursing homes has any impact on UI. This randomized controlled trial was a substudy of a Nordic multicenter study. Participants had to be >65 years, have stayed in the NH for more than 3 months and in need of assistance in at least one ADL. A total of 98 residents were randomly allocated to either a training group (n = 48) or a control group (n = 50) after baseline registrations. The training program lasted for 3 months and included accommodated physical activity and ADL training. Personal treatment goals were elicited for each subject. The control group received their usual care. The main outcome measure was UI as measured by a 24-hour pad-weighing test. There was no statistically significant difference between the groups on this measure at baseline (P = 0.15). Changes were calculated from baseline to 3 months after the end of the intervention. Altogether, 68 participants were included in the analysis, 35 in the intervention group and 33 in the control group. The average age was 84.3 years. The 3 months' postintervention adjusted mean difference between groups according to amount of leakage was 191 g (P = 0.03). This result was statistically significant after adjusting for baseline level, age, sex, and functional status. The leakage increased in residents not receiving the experimental intervention, while UI in the training group showed improvement. The intervention group had significant better results compared with the control group after an individualized training program designed to improve ADL and physical capacity. Further studies are needed to evaluate the
Arias-Buría, José L; Fernández-de-Las-Peñas, César; Palacios-Ceña, María; Koppenhaver, Shane L; Salom-Moreno, Jaime
This randomized clinical trial investigated the effectiveness of exercise versus exercise plus trigger point (TrP) dry needling (TrP-DN) in subacromial pain syndrome. A randomized parallel-group trial, with 1-year follow-up was conducted. Fifty subjects with subacromial pain syndrome were randomly allocated to receive exercise alone or exercise plus TrP-DN. Participants in both groups were asked to perform an exercise program of the rotator cuff muscles twice daily for 5 weeks. Further, patients allocated to the exercise plus TrP-DN group also received dry needling to active TrPs in the muscles reproducing shoulder symptoms during the second and fourth sessions. The primary outcome was pain-related disability assessed using the Disabilities of the Arm, Shoulder, and Hand questionnaire. Secondary outcomes included mean current pain and the worst pain experienced in the shoulder during the previous week. They were assessed at baseline, 1 week, and 3, 6, and 12 months after the end of treatment. Analysis was according to intention to treat with mixed analysis of covariance adjusted for baseline outcomes. At 12 months, 47 patients (94%) completed follow-up. Statistically larger improvements (all, P < .01) in shoulder disability was found for the exercise plus TrP-DN group at all follow-up periods (post: Δ -20.6 [95% confidence interval (CI) -23.8 to -17.4]; 3 months: Δ -23.2 [95% CI -28.3 to -18.1)]; 6 months: Δ -23.6 [95% CI -28.9 to -18.3]; 12 months: Δ -13.9 [95% CI -17.5 to -10.3]). Both groups exhibited similar improvements in shoulder pain outcomes at all follow-up periods. The inclusion of TrP-DN with an exercise program was effective for improving disability in subacromial pain syndrome. No greater improvements in shoulder pain were observed. This study found that the inclusion of 2 sessions of TrP-DN into an exercise program was effective for improving shoulder pain-related disability at short-, medium-, and long-term; however, no greater
Rhoda, Dale A; Murray, David M; Andridge, Rebecca R; Pennell, Michael L; Hade, Erinn M
Multiple baseline designs (MBDs) have been suggested as alternatives to group-randomized trials (GRT). We reviewed structural features of MBDs and considered their potential effectiveness in public health research. We also reviewed the effect of staggered starts on statistical power. We reviewed the MBD literature to identify key structural features, recent suggestions that MBDs be adopted in public health research, and the literature on power in GRTs with staggered starts. We also computed power for MBDs and GRTs. The features that have contributed to the success of small MBDs in some fields are not likely to translate well to public health research. MBDs can be more powerful than GRTs under some conditions, but those conditions involve assumptions that require careful evaluation in practice. MBDs will often serve better as a complement of rather than as an alternative to GRTs. GRTs may employ staggered starts for logistical or ethical reasons, but this will always increase their duration and will often increase their cost.
Asakura, Koko; Hamasaki, Toshimitsu; Sugimoto, Tomoyuki; Hayashi, Kenichi; Evans, Scott R; Sozu, Takashi
We discuss sample size determination in group-sequential designs with two endpoints as co-primary. We derive the power and sample size within two decision-making frameworks. One is to claim the test intervention’s benefit relative to control when superiority is achieved for the two endpoints at the same interim timepoint of the trial. The other is when the superiority is achieved for the two endpoints at any interim timepoint, not necessarily simultaneously. We evaluate the behaviors of sample size and power with varying design elements and provide a real example to illustrate the proposed sample size methods. In addition, we discuss sample size recalculation based on observed data and evaluate the impact on the power and Type I error rate. PMID:24676799
Llauradó, Elisabet; Aceves-Martins, Magaly; Tarro, Lucia; Papell-Garcia, Ignasi; Puiggròs, Francesc; Arola, Lluís; Prades-Tena, Jordi; Montagut, Marta; Moragas-Fernández, Carlota M; Solà, Rosa; Giralt, Montse
The encouragement of healthy lifestyles for obesity prevention in young people is a public health priority. The European Youth Tackling Obesity (EYTO) project is a multicentric intervention project with participation from the United Kingdom, Portugal, the Czech Republic and Spain. The general aim of the EYTO project is to improve lifestyles, including nutritional habits and physical activity practice, and to prevent obesity in socioeconomically disadvantaged and vulnerable adolescents. The EYTO project works through a peer-led social marketing intervention that is designed and implemented by the adolescents of each participating country. Each country involved in the project acts independently. This paper describes the "Som la Pera" intervention Spanish study that is part of the EYTO project. In Spain, the research team performed a cluster randomised controlled intervention over 2 academic years (2013-2015) in which 2 high-schools were designated as the control group and 2 high-schools were designated as the intervention group, with a minimum of 121 schoolchildren per group. From the intervention group, 5 adolescents with leadership characteristics, called "Adolescent Challenge Creators" (ACCs), were recruited. These 5 ACCs received an initial 4 h training session about social marketing principles and healthy lifestyle theory, followed by 24 sessions (1.30 h/session) divided in two academic years to design and implement activities presented as challenges to encourage healthy lifestyles among their peers, the approximately 180-200 high-school students in the intervention group. During the design of the intervention, it was essential that the ACCs used the 8 social marketing criteria (customer orientation, behaviour, theory, insight, exchange, competition, segmentation and methods mix). The expected primary outcomes from the Spanish intervention will be as follows: increases in the consumption of fruits and vegetables and physical activity practice along with
Herman, Keith C; Reinke, Wendy M
For children with the most serious and persistent academic and behavior problems, parent involvement in education, particularly teacher perceptions of involvement, is essential to avert their expected long-term negative outcomes. Despite the widespread interest in and perceived importance of parent involvement in education, however, few experimental studies have evaluated programs and practices to promote it. In this group randomized trial, we examined the effects of the Incredible Years Teacher Classroom Management program (IY TCM) on teacher perceptions of contact and comfort with parents. One hundred five classrooms with 1818 students were randomly assigned to an IY TCM or to a control, business as usual condition. Measures of key constructs included teacher ratings of parent and student behaviors, direct observations in the classroom, and a standardized academic achievement test. Latent transition analysis (LTA) was used to identify patterns of involvement over time and to determine if intervention condition predicted postintervention patterns and transitions. Four patterns of involvement were identified at baseline and at follow-up; parents of students with academic and behavior problems were most likely to be in classes with the least adaptive involvement patterns. Intervention status predicted group membership at follow-up. Specifically, intervention classroom parents were significantly more likely to transition to more adaptive teacher-rated parenting profiles at follow-up compared to control classroom parents. This is the first randomized trial we are aware of that has found that teacher training can alter teacher perceptions of parent involvement patterns. Clinical implications for students with behavior and academic problems are discussed. (PsycINFO Database Record (c) 2017 APA, all rights reserved).
Structural Validation and Multiple Group Assessment of the Short Internalized Homonegativity Scale in Homosexual and Bisexual Men in 38 European Countries: Results From the European MSM Internet Survey.
Tran, Ha; Ross, Michael W; Diamond, Pamela M; Berg, Rigmor C; Weatherburn, Peter; Schmidt, Axel J
Internalized homonegativity (IH) is the internalization of negative attitudes and assumptions about homosexual people by homosexual people themselves. To measure IH, Smolenski, Diamond, Ross, and Rosser (2010) and Ross, Rosser, and Smolenski (2010) revised the Reactions to Homosexuality Scale (RHS) to develop the Short Internalized Homonegativity Scale (SIHS) with eight items. Using the European Men Who Have Sex With Men Internet Survey (EMIS) data, with an analytic sample of 130,718 gay and bisexual men in 38 European countries, we confirmed the validity of the SIHS scale in both training and validation data, in strata of Ross, Berg, et al.'s (2013) three "homosexual discrimination" country clusters, of age, and of education level. However, the performance was less adequate in comparison of gay versus bisexually identified individuals. The latent SIHS structure contains only minor variations across these three strata. The seven-item scale performed as well as the eight-item scale. The SIHS is a promising candidate for standard IH measures, which is invariant across cultural, age, and educational strata.
Manners, Ian James
Political theory of European union, through an engagement between political concepts and theoretical understandings, provides a means of identifying the EU as a political object. It is argued that understanding the projects, processes and products of European union, based on ‘sharing’ or ‘communion......’, provides a better means of perceiving the EU as a political object rather than terms such as ‘integration’ or ‘co-operation’. The concept of ‘European communion’ is defined as the ‘subjective sharing of relationships’, understood as the extent to which individuals or groups believe themselves to be sharing...... relations (or not), and the consequences of these beliefs for European political projects, processes and products. By exploring European communion through an engagement with contemporary political theory, using very brief illustrations from the Treaty of Lisbon, the article also suggests that European...
Peterson, Ulla; Bergström, Gunnar; Samuelsson, Mats; Asberg, Marie; Nygren, Ake
This paper is a report of a study to test the effect of participating in a reflecting peer-support group on self-reported health, burnout and on perceived changes in work conditions. Stress-related conditions are one of the most common causes for long-term sick-leave. There is limited evidence for the effectiveness of person-directed interventions aimed at reducing stress levels in healthcare workers. Prior research in the relationship between support and burnout show somewhat inconsistent results. A randomized controlled trial with peer-support groups as the intervention was conducted with 660 healthcare workers scoring above the 75th percentile on the exhaustion dimension of the Oldenburg Burnout Inventory. One hundred and fifty-one (22.9%) agreed to participate. The intervention started in 2002 with 51 participants (96.1% were women), 80 of whom constituted the control group. Potential differences in outcome measures 12 months after the intervention were compared using ancova, and data collected was completed in 2004. Qualitative content analyses were used to analyse reported experiences from group participation. Statistically significant intervention effects were found for general health, perceived quantitative demands at work, participation and development opportunities at work and in support at work. Seven categories of experiences from participating were identified: talking to others in a similar situation, knowledge, sense of belonging, self-confidence, structure, relief of symptoms and behavioural change. Peer-support groups using a problem-based method could be a useful and comparatively inexpensive tool in alleviating work-related stress and burnout.
Premature ovarian failure and fertility in long-term survivors of Hodgkin's lymphoma: a European Organisation for Research and Treatment of Cancer Lymphoma Group and Groupe d'Etude des Lymphomes de l'Adulte Cohort Study.
van der Kaaij, Marleen A E; Heutte, Natacha; Meijnders, Paul; Abeilard-Lemoisson, Edwige; Spina, Michele; Moser, Elizabeth C; Allgeier, Anouk; Meulemans, Bart; Simons, Arnold H M; Lugtenburg, Pieternella J; Aleman, Berthe M P; Noordijk, Evert M; Fermé, Christophe; Thomas, José; Stamatoullas, Aspasia; Fruchart, Christophe; Brice, Pauline; Gaillard, Isabelle; Bologna, Serge; Ong, Francisca; Eghbali, Houchingue; Doorduijn, Jeanette K; Morschhauser, Franck; Sebban, Catherine; Roesink, Judith M; Bouteloup, Marie; Van Hoof, Achiel; Raemaekers, John M M; Henry-Amar, Michel; Kluin-Nelemans, Hanneke C
In this large cohort of Hodgkin's lymphoma survivors with long follow-up, we estimated the impact of treatment regimens on premature ovarian failure (POF) occurrence and motherhood, including safety of nonalkylating chemotherapy and dose-response relationships for alkylating chemotherapy and age at treatment. The Life Situation Questionnaire was sent to 1,700 women treated in European Organisation for Research and Treatment of Cancer and Groupe d'Étude des Lymphomes de l'Adulte trials between 1964 and 2004. Women treated between ages 15 and 40 years and currently not using hormonal contraceptives (n = 460) were selected to assess occurrence of POF. Cumulative POF risk was estimated using the life-table method. Predictive factors were assessed by Cox regression analysis. Median follow-up was 16 years (range, 5 to 45 years). Cumulative risk of POF after alkylating chemotherapy was 60% (95% CI, 41% to 79%) and only 3% (95% CI, 1% to 7%) after nonalkylating chemotherapy (doxorubicin, bleomycin, vinblastine, and dacarbazine; epirubicin, bleomycin, vinblastine, and prednisone). Dose relationship between alkylating chemotherapy and POF occurrence was linear. POF risk increased by 23% per year of age at treatment. In women treated without alkylating chemotherapy at age younger than 32 years and age 32 years or older, cumulative POF risks were 3% (95% CI, 1% to 16%) and 9% (95% CI, 4% to 18%), respectively. If menstruation returned after treatment, cumulative POF risk was independent of age at treatment. Among women who ultimately developed POF, 22% had one or more children after treatment, compared with 41% of women without POF. Nonalkylating chemotherapy carries little to no excess risk of POF. Dose-response relationships for alkylating chemotherapy and age at treatment are both linear. Timely family planning is important for women at risk of POF.
Charron, Philippe; Arad, Michael; Arbustini, Eloisa; Basso, Cristina; Bilinska, Zofia; Elliott, Perry; Helio, Tiina; Keren, Andre; McKenna, William J.; Monserrat, Lorenzo; Pankuweit, Sabine; Perrot, Andreas; Rapezzi, Claudio; Ristic, Arsen; Seggewiss, Hubert; van Langen, Irene; Tavazzi, Luigi
Advances in molecular genetics present new opportunities and challenges for cardiologists who manage patients and families with cardiomyopathies. The aims of this position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases are to review the general
VANDENPLAS, Y; ASHKENAZI, A; BELLI, D; BLECKER, U; BOIGE, N; BOUQUET, J; CADRANEL, S; CEZARD, JP; CUCCHIARA, S; DEVREKER, T; DUPONT, C; GEBOES, K; GOTTRAND, F; HEYMANS, HSA; JASINSKI, C; KNEEPKENS, CMF; KOLETZKO, S; MILLA, P; MOUGENOT, JF; NAVARRO, J; NEWELL, SJ; NUSSLE, D; OLAFSDOTTIR, E; POLANCO, [No Value; RAVELLI, A; SANDHU, BK; TOLBOOM, J
In this article, the Working Group on Gastro-Oesophageal Reflux of the European Society of Paediatric Gastroenterology and Nutrition presents and discusses a definition of reflux esophagitis and recommends a diagnostic approach and therapeutic management for this condition. Histologic criteria for
Perros, Petros; Žarković, Miloš; Azzolini, Claudio; Ayvaz, Göksun; Baldeschi, Lelio; Bartalena, Luigi; Boschi, Antonella; Bournaud, Claire; Brix, Thomas Heiberg; Covelli, Danila; Ćirić, Slavica; Daumerie, Chantal; Eckstein, Anja; Fichter, Nicole; Führer, Dagmar; Hegedüs, Laszlo; Kahaly, George J.; Konuk, Onur; Lareida, Jürg; Lazarus, John; Leo, Marenza; Mathiopoulou, Lemonia; Menconi, Francesca; Morris, Daniel; Okosieme, Onyebuchi; Orgiazzi, Jaques; Pitz, Susanne; Salvi, Mario; Vardanian-Vartin, Cristina; Wiersinga, Wilmar; Bernard, Martine; Clarke, Lucy; Currò, Nicola; Dayan, Colin; Dickinson, Jane; Knežević, Miroslav; Lane, Carol; Marcocci, Claudio; Marinò, Michele; Möller, Lars; Nardi, Marco; Neoh, Christopher; Pearce, Simon; von Arx, George; Törüner, Fosun Baloş
The epidemiology of Graves' orbitopathy (GO) may be changing. The aim of the study was to identify trends in presentation of GO to tertiary centres and initial management over time. Prospective observational study of European Group On Graves' Orbitopathy (EUGOGO) centres. All new referrals with a
Fernández-de-Las Peñas, César; Ortega-Santiago, Ricardo; de la Llave-Rincón, Ana I; Martínez-Perez, Almudena; Fahandezh-Saddi Díaz, Homid; Martínez-Martín, Javier; Pareja, Juan A; Cuadrado-Pérez, Maria L
This randomized clinical trial investigated the effectiveness of surgery compared with physical therapy consisting of manual therapies including desensitization maneuvers in carpal tunnel syndrome (CTS). The setting was a public hospital and 2 physical therapy practices in Madrid, Spain. One hundred twenty women with CTS were enrolled between February 2013 and January 2014, with 1-year follow-up completed in January 2015. Interventions consisted of 3 sessions of manual therapies including desensitization maneuvers of the central nervous system (physical therapy group, n = 60) or decompression/release of the carpal tunnel (surgical group, n = 60). The primary outcome was pain intensity (mean pain and the worst pain), and secondary outcomes included functional status and symptoms severity subscales of the Boston Carpal Tunnel Questionnaire and the self-perceived improvement. They were assessed at baseline and 1, 3, 6, and 12 months by a blinded assessor. Analysis was by intention to treat. At 12 months, 111 (92%) women completed the follow-up (55/60 physical therapy, 56/60 surgery). Adjusted analyses showed an advantage (all, P physical therapy at 1 and 3 months in mean pain (Δ -2.0 [95% confidence interval (CI) -2.8 to -1.2]/-1.3 [95% CI -2.1 to -.6]), the worst pain (Δ -2.9 [-4.0 to -2.0]/-2.0 [-3.0 to -.9]), and function (Δ -.8 [-1.0 to -.6]/-.3 [-.5 to -.1]), respectively. Changes in pain and function were similar between the groups at 6 and 12 months. The 2 groups had similar improvements in the symptoms severity subscale of the Boston Carpal Tunnel Questionnaire at all follow-ups. In women with CTS, physical therapy may result in similar outcomes on pain and function to surgery. http://www.clinicaltrials.gov, ClinicalTrials.gov, NCT01789645. This study found that surgery and physical manual therapies including desensitization maneuvers of the central nervous system were similarly effective at medium-term and long-term follow-ups for improving pain and
Full Text Available Abstract Background Because of the implant-related problems with pedicle screw-based spinal instrumentations, other types of fixation have been tried in spinal arthrodesis. One such technique is the direct trans-pedicular, trans-discal screw fixation, pioneered by Grob for spondylolisthesis. The newly developed GO-LIF procedure expands the scope of the Grob technique in several important ways and adds security by means of robotic-assisted navigation. This is the first clinical trial on the GO-LIF procedure and it will assess safety and efficacy. Methods/Design Multicentric prospective study with n = 40 patients to undergo single level instrumented spinal arthrodesis of the lumbar or the lumbosacral spine, based on a diagnosis of: painful disc degeneration, painful erosive osteochondrosis, segmental instability, recurrent disc herniation, spinal canal stenosis or foraminal stenosis. The primary target criteria with regards to safety are: The number, severity and cause of intra- and perioperative complications. The number of significant penetrations of the cortical layer of the vertebral body by the implant as recognized on postoperative CT. The primary target parameters with regards to feasibility are: Performance of the procedure according to the preoperative plan. The planned follow-up is 12 months and the following scores will be evaluated as secondary target parameters with regards to clinical improvement: VAS back pain, VAS leg pain, Oswestry Disability Index, short form - 12 health questionnaire and the Swiss spinal stenosis questionnaire for patients with spinal claudication. The secondary parameters with regards to construct stability are visible fusion or lack thereof and signs of implant loosening, implant migration or pseudarthrosis on plain and functional radiographs. Discussion This trial will for the first time assess the safety and efficacy of guided oblique lumbar interbody fusion. There is no control group, but the results, the
Perros, P; Hegedüs, L; Bartalena, L; Marcocci, C; Kahaly, G J; Baldeschi, L; Salvi, M; Lazarus, J H; Eckstein, A; Pitz, S; Boboridis, K; Anagnostis, P; Ayvaz, G; Boschi, A; Brix, T H; Currò, N; Konuk, O; Marinò, M; Mitchell, A L; Stankovic, B; Törüner, F B; von Arx, G; Zarković, M; Wiersinga, W M
Graves' orbitopathy (GO) is an autoimmune condition, which is associated with poor clinical outcomes including impaired quality of life and socio-economic status. Current evidence suggests that the incidence of GO in Europe may be declining, however data on the prevalence of this disease are sparse. Several clinical variants of GO exist, including euthyroid GO, recently listed as a rare disease in Europe (ORPHA466682). The objective was to estimate the prevalence of GO and its clinical variants in Europe, based on available literature, and to consider whether they may potentially qualify as rare. Recent published data on the incidence of GO and Graves' hyperthyroidism in Europe were used to estimate the prevalence of GO. The position statement was developed by a series of reviews of drafts and electronic discussions by members of the European Group on Graves' Orbitopathy. The prevalence of GO in Europe is about 10/10,000 persons. The prevalence of other clinical variants is also low: hypothyroid GO 0.02-1.10/10,000; GO associated with dermopathy 0.15/10,000; GO associated with acropachy 0.03/10,000; asymmetrical GO 1.00-5.00/10,000; unilateral GO 0.50-1.50/10,000. GO has a prevalence that is clearly above the threshold for rarity in Europe. However, each of its clinical variants have a low prevalence and could potentially qualify for being considered as a rare condition, providing that future research establishes that they have a distinct pathophysiology. EUGOGO considers this area of academic activity a priority.
Nyhsen, Christiane M; Humphreys, Hilary; Koerner, Roland J; Grenier, Nicolas; Brady, Adrian; Sidhu, Paul; Nicolau, Carlos; Mostbeck, Gerhard; D'Onofrio, Mirko; Gangi, Afshin; Claudon, Michel
The objective of these recommendations is to highlight the importance of infection prevention and control in ultrasound (US), including diagnostic and interventional settings. Review of available publications and discussion within a multidisciplinary group consistent of radiologists and microbiologists, in consultation with European patient and industry representatives. Good basic hygiene standards are essential. All US equipment must be approved prior to first use, including hand held devices. Any equipment in direct patient contact must be cleaned and disinfected prior to first use and after every examination. Regular deep cleaning of the entire US machine and environment should be undertaken. Faulty transducers should not be used. As outlined in presented flowcharts, low level disinfection is sufficient for standard US on intact skin. For all other minor and major interventional procedures as well as all endo-cavity US, high level disinfection is mandatory. Dedicated transducer covers must be used when transducers are in contact with mucous membranes or body fluids and sterile gel should be used inside and outside covers. Good standards of basic hygiene and thorough decontamination of all US equipment as well as appropriate use of US gel and transducer covers are essential to keep patients safe. • Transducers must be cleaned/disinfected before first use and after every examination. • Low level disinfection is sufficient for standard US on intact skin. • High level disinfection is mandatory for endo-cavity US and all interventions. • Dedicated transducer covers must be used for endo-cavity US and all interventions. • Sterile gel should be used for all endo-cavity US and all interventions.
Sahmoud, T; Postmus, PE; van Pottelsberghe, C; Mattson, K; Tammilehto, L; Splinter, TAW; Planting, AST; Sutedja, T; van Pawel, J; van Zandwijk, N; Baas, P; Roozendaal, KJ; Schrijver, M; Kirkpatrick, A; Van Glabbeke, M; Ardizzoni, A; Giaccone, G
Intravenous and oral etoposide (VP 16-213) were tested in two sequential phase II trials in chemotherapy-naive patients with malignant pleural mesothelioma. In the first trial, etoposide was given intravenously (i.v.) at a dose of 150 mg/m(2) on days 1, 3 and 5 every 3 weeks. The second trial
Celis-Morales, Carlos; Marsaux, Cyril Fm; Livingstone, Katherine M; Navas-Carretero, Santiago; San-Cristobal, Rodrigo; Fallaize, Rosalind; Macready, Anna L; O'Donovan, Clare; Woolhead, Clara; Forster, Hannah; Kolossa, Silvia; Daniel, Hannelore; Moschonis, George; Mavrogianni, Christina; Manios, Yannis; Surwillo, Agnieszka; Traczyk, Iwona; Drevon, Christian A; Grimaldi, Keith; Bouwman, Jildau; Gibney, Mike J; Walsh, Marianne C; Gibney, Eileen R; Brennan, Lorraine; Lovegrove, Julie A; Martinez, J Alfredo; Saris, Wim Hm; Mathers, John C
Background: There has been limited evidence about whether genotype-tailored advice provides extra benefits in reducing obesity-related traits compared with the benefits of conventional one-size-fits-all advice.Objective: We determined whether the disclosure of information on fat-mass and obesity-associated (FTO) genotype risk had a greater effect on a reduction of obesity-related traits in risk carriers than in nonrisk carriers across different levels of personalized nutrition.Design: A total of 683 participants (women: 51%; age range: 18-73 y) from the Food4Me randomized controlled trial were included in this analysis. Participants were randomly assigned to 4 intervention arms as follows: level 0, control group; level 1, dietary group; level 2, phenotype group; and level 3, genetic group. FTO (single nucleotide polymorphism rs9939609) was genotyped at baseline in all participants, but only subjects who were randomly assigned to level 3 were informed about their genotypes. Level 3 participants were stratified into risk carriers (AA/AT) and nonrisk carriers (TT) of the FTO gene for analyses. Height, weight, and waist circumference (WC) were self-measured and reported at baseline and months 3 and 6.Results: Changes in adiposity markers were greater in participants who were informed that they carried the FTO risk allele (level 3 AT/AA carriers) than in the nonpersonalized group (level 0) but not in the other personalized groups (level 1 and 2). Mean reductions in weight and WC at month 6 were greater for FTO risk carriers than for noncarriers in the level 3 group [-2.28 kg (95% CI: -3.06, -1.48 kg) compared with -1.99 kg (-2.19, -0.19 kg), respectively (P = 0.037); and -4.34 cm (-5.63, -3.08 cm) compared with -1.99 cm (-4.04, -0.05 cm), respectively, (P = 0.048)].Conclusions: There are greater body weight and WC reductions in risk carriers than in nonrisk carriers of the FTO gene. This trial was registered at clinicaltrials.gov as NCT01530139. © 2017 American Society
Breugom, A J; van Gijn, W; Muller, E W; Berglund, Å; van den Broek, C B M; Fokstuen, T; Gelderblom, H; Kapiteijn, E; Leer, J W H; Marijnen, C A M; Martijn, H; Meershoek-Klein Kranenbarg, E; Nagtegaal, I D; Påhlman, L; Punt, C J A; Putter, H; Roodvoets, A G H; Rutten, H J T; Steup, W H; Glimelius, B; van de Velde, C J H
The discussion on the role of adjuvant chemotherapy for rectal cancer patients treated according to current guidelines is still ongoing. A multicentre, randomized phase III trial, PROCTOR-SCRIPT, was conducted to compare adjuvant chemotherapy with observation for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision (TME). The PROCTOR-SCRIPT trial recruited patients from 52 hospitals. Patients with histologically proven stage II or III rectal adenocarcinoma were randomly assigned (1:1) to observation or adjuvant chemotherapy after preoperative (chemo)radiotherapy and TME. Radiotherapy consisted of 5 × 5 Gy. Chemoradiotherapy consisted of 25 × 1.8-2 Gy combined with 5-FU-based chemotherapy. Adjuvant chemotherapy consisted of 5-FU/LV (PROCTOR) or eight courses capecitabine (SCRIPT). Randomization was based on permuted blocks of six, stratified according to centre, residual tumour, time between last irradiation and surgery, and preoperative treatment. The primary end point was overall survival. Of 470 enrolled patients, 437 were eligible. The trial closed prematurely because of slow patient accrual. Patients were randomly assigned to observation (n = 221) or adjuvant chemotherapy (n = 216). After a median follow-up of 5.0 years, 5-year overall survival was 79.2% in the observation group and 80.4% in the chemotherapy group [hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.62-1.39; P = 0.73]. The HR for disease-free survival was 0.80 (95% CI 0.60-1.07; P = 0.13). Five-year cumulative incidence for locoregional recurrences was 7.8% in both groups. Five-year cumulative incidence for distant recurrences was 38.5% and 34.7%, respectively (P = 0.39). The PROCTOR-SCRIPT trial could not demonstrate a significant benefit of adjuvant chemotherapy with fluoropyrimidine monotherapy after preoperative (chemo)radiotherapy and TME on overall survival, disease-free survival, and recurrence rate. However, this trial did not complete
A European feasibility study on environmental exposure to extremely low-frequency electromagnetic fields (ELF-EMF) and cancer was conducted. The study was motivated by public health concern about possible adverse health effects associated with ELF-EMF exposure. A review of completed research in Europe was conducted. Information on the methods and accessibility of new epidemiologic studies were requested and reviewed. Eight studies on environmental ELF-EMF exposure have been completed in Europe while 15 large studies are in progress. Although there is no known mechanism by which electric or magnetic fields of this frequency could play a role in the development of cancer or other adverse health effects, the results of the studies conducted so far provide some support for the hypothesis that they are associated with the incidence of childhood leukemia. The best use of available data will be made through a pooled re-analysis of data, particularly those on childhood tumors. It is recommended to apply multiple methods for exposure assessment in view of the heterogeneity in the methods used in different studies. New multicenter case-referent studies should not be initiated until the results of the large on-going studies have been reported. Prospective cohort studies will have to be very large to identify moderate excess risks resulting from environmental exposure to ELF-EMF, and their feasibility should be discussed after the results of the on-going case-referent studies have been reported. A European collaborative approach will lead to greater statistical power and will assess the exposure-effect association under differing exposure patterns and distributions of potential confounding factors.
Aliyu, Gambo; Mohammad, Mukhtar; Saidu, Ahmed; Mondal, Prosanta; Charurat, Man; Abimiku, Alash'le; Nasidi, Abdulsalami; Blattner, William
The purpose of this survey is to generate baseline data on the level of HIV infection awareness and willingness to participate (WTP) in hypothetical vaccine trials, ahead of any trial conduct in Nigeria. In a cross-sectional survey, 500 respondents were interviewed, including sex workers, male motorcycle taxi drivers, students, and the general public. About 153 (30.6%) of the respondents did not believe that correct and consistent use of condom can protect people from getting HIV, while about 66 (13.2%) respondents believed it is possible to get HIV by sharing meal with an infected person. Population groups considered at high risk for HIV were less aware of the disease, however, they were more willing to participate in HIV vaccine trials compared those at low risk of the disease. A total of 55% expressed WTP in a hypothetical vaccine trial after they were informed about it. Age, population group, and ethnicity were significantly associated with WTP.
Greene, Carolyn J; Morland, Leslie A; Macdonald, Alexandra; Frueh, B Christopher; Grubbs, Kathleen M; Rosen, Craig S
Video teleconferencing (VTC) is used for mental health treatment delivery to geographically remote, underserved populations. However, few studies have examined how VTC affects individual or group psychotherapy processes. This study compares process variables such as therapeutic alliance and attrition among participants receiving anger management group therapy either through traditional face-to-face delivery or by VTC. The current study represents secondary analyses of a randomized noninferiority trial (Morland et al., in press) in which clinical effectiveness of VTC delivery proved noninferior to in-person delivery. Participants were male veterans (N = 112) with posttraumatic stress disorder (PTSD) and moderate to severe anger problems. The present study examined potential differences in process variables, including therapeutic alliance, satisfaction, treatment credibility, attendance, homework completion, and attrition. No significant differences were found between the two modalities on most process variables. However, individuals in the VTC condition exhibited lower alliance with the group leader than those in the in-person condition. Mean self-leader alliance scores were 4.2 (SD = 0.8) and 4.5 (SD = 0.4), respectively, where 5 represents strongly agree and 4 represents agree with positive statements about the relationship, suggesting that participants in both conditions felt reasonably strong alliance in absolute terms. Individuals who had stronger alliance tended to have better anger outcomes, yet the effect was not strong enough to result in the VTC condition producing inferior aggregate outcomes. Our findings suggest that even if group psychotherapy via VTC differs in subtle ways from in-person delivery, VTC is a viable and effective means of delivering psychotherapy. Copyright 2010 APA, all rights reserved.
Beukes, Eldré W; Allen, Peter M; Manchaiah, Vinaya; Baguley, David M; Andersson, Gerhard
Managing chronic tinnitus is challenging, and innovative ways to address the resulting health-care burden are required. Internet-based cognitive behavioral therapy (iCBT) for tinnitus shows promise as a cost-effective treatment option. The feasibility and effectiveness of iCBT in the United Kingdom are yet to be explored. Furthermore, it is not known if iCBT can be supported by an audiologist rather than a psychologist. This study aimed to determine the feasibility of guided iCBT using audiological support on tinnitus distress and tinnitus-related comorbidities. Furthermore, it aimed to establish the feasibility of iCBT for tinnitus distress in the United Kingdom, by determining recruitment, attrition, and compliance rates. Finally, it aimed to identify which aspects of the protocol require refinement for subsequent clinical trials. A single-group open trial design was implemented. This study would serve as a prerequisite study, to identify barriers, before undertaking effectiveness trials. Participants consisted of 37 adults (18 males, 19 females), with an age range of between 50 and 59 yr. The mean preintervention tinnitus severity rating was 56.15 (standard deviation = 18.35), which is categorized as "severe tinnitus" as measured by the Tinnitus Functional Index (TFI). Five participants withdrew during the study, and 29 of the remaining participants completed the postintervention questionnaire. The guided iCBT intervention ran over an eight-week period and consisted of 16 obligatory modules and five optional modules. The intervention was designed to be interactive, interesting, and stimulating. A key element was the provision of support from an audiologist throughout the program. Online questionnaires were used throughout the study. These were administered at baseline and postintervention to determine attrition and compliance rates and to facilitate sample size estimates for further clinical trials. Outcome measures for tinnitus severity, hearing handicap
Organization of heart failure management in European Society of Cardiology member countries: survey of the Heart Failure Association of the European Society of Cardiology in collaboration with the Heart Failure National Societies/Working Groups.
Seferovic, Petar M; Stoerk, Stefan; Filippatos, Gerasimos; Mareev, Viacheslav; Kavoliuniene, Ausra; Ristic, Arsen D; Ponikowski, Piotr; McMurray, John; Maggioni, Aldo; Ruschitzka, Frank; van Veldhuisen, Dirk J; Coats, Andrew; Piepoli, Massimo; McDonagh, Theresa; Riley, Jillian; Hoes, Arno; Pieske, Burkert; Dobric, Milan; Papp, Zoltan; Mebazaa, Alexandre; Parissis, John; Ben Gal, Tuvia; Vinereanu, Dragos; Brito, Dulce; Altenberger, Johann; Gatzov, Plamen; Milinkovic, Ivan; Hradec, Jaromír; Trochu, Jean-Noel; Amir, Offer; Moura, Brenda; Lainscak, Mitja; Comin, Josep; Wikström, Gerhard; Anker, Stefan
The aim of this document was to obtain a real-life contemporary analysis of the demographics and heart failure (HF) statistics, as well as the organization and major activities of the Heart Failure National Societies (HFNS) in European Society of Cardiology (ESC) member countries. Data from 33 countries were collected from HFNS presidents/representatives during the first Heart Failure Association HFNS Summit (Belgrade, Serbia, 29 October 2011). Data on incidence and/or prevalence of HF were available for 22 countries, and the prevalence of HF ranged between 1% and 3%. In five European and one non-European ESC country, heart transplantation was reported as not available. Natriuretic peptides and echocardiography are routinely applied in the management of acute HF in the median of 80% and 90% of centres, respectively. Eastern European and Mediterranean countries have lower availability of natriuretic peptide testing for acute HF patients, compared with other European countries. Almost all countries have organizations dealing specifically with HF. HFNS societies for HF patients exist in only 12, while in 16 countries HF patient education programmes are active. Most HFNS reported that no national HF registry exists in their country. Fifteen HFNS produced national HF guidelines, while 19 have translated the ESC HF guidelines. Most HFNS (n = 23) participated in the organization of the European HF Awareness Day. This document demonstrated significant heterogeneity in the organization of HF management, and activities of the national HF working groups/associations. High availability of natriuretic peptide and echocardiographic measurements was revealed, with differences between developed countries and countries in transition.
Jelsma, Judith G M; van Poppel, Mireille N M; Galjaard, Sander; Desoye, Gernot; Corcoy, Rosa; Devlieger, Roland; van Assche, Andre; Timmerman, Dirk; Jans, Goele; Harreiter, Jurgen; Kautzky-Willer, Alexandra; Damm, Peter; Mathiesen, Elisabeth R; Jensen, Dorte M; Andersen, Liselotte; Dunne, Fidelma; Lapolla, Annunziata; Di Cianni, Graziano; Bertolotto, Alessandra; Wender-Oegowska, Ewa; Zawiejska, Agnieszka; Blumska, Kinga; Hill, David; Rebollo, Pablo; Snoek, Frank J; Simmons, David
Gestational diabetes mellitus (GDM) is an increasing problem world-wide. Lifestyle interventions and/or vitamin D supplementation might help prevent GDM in some women. Pregnant women at risk of GDM (BMI ≥ 29 (kg/m(2))) from 9 European countries will be invited to participate and consent obtained before 19+6 weeks of gestation. After giving informed consent, women without GDM will be included (based on IADPSG criteria: fasting glucosephysical activity (PA), 3) HE+PA, 4) control, 5) HE+PA+vitamin D, 6) HE+PA+placebo, 7) vitamin D alone, 8) placebo alone), pre-stratified for each site. In total, 880 women will be included with 110 women allocated to each arm. Between entry and 35 weeks of gestation, women allocated to a lifestyle intervention will receive 5 face-to-face, and 4 telephone coaching sessions, based on the principles of motivational interviewing. The lifestyle intervention includes a discussion about the risks of GDM, a weight gain target physical activity 'messages' depending on randomization. Fidelity is monitored by the use of a personal digital assistance (PDA) system. Participants randomized to the vitamin D intervention receive either 1600 IU vitamin D or placebo for daily intake until delivery. Data is collected at baseline measurement, at 24-28 weeks, 35-37 weeks of gestation and after delivery. Primary outcome measures are gestational weight gain, fasting glucose and insulin sensitivity, with a range of obstetric secondary outcome measures including birth weight. DALI is a unique Europe-wide randomised controlled trial, which will gain insight into preventive measures against the development of GDM in overweight and obese women. ISRCTN70595832.
Rohde, Paul; Stice, Eric; Shaw, Heather; Gau, Jeff M
Conduct a pilot trial testing whether a new cognitive-behavioral (CB) group prevention program that incorporated cognitive-dissonance change principles was feasible and appeared effective in reducing depressive symptoms and major depressive disorder onset relative to a brochure control condition in college students with elevated depressive symptoms. 59 college students (M age = 21.8, SD = 2.3; 68% female, 70% White) were randomized to the 6-session Change Ahead group or educational brochure control condition, completing assessments at pretest, posttest, and 3-month follow-up. Recruitment and screening methods were effective and intervention attendance was high (86% attended all 6 sessions). Change Ahead participants showed medium-large reductions in depressive symptoms at posttest (M d = 0.64), though the effect attenuated by 3-month follow-up. Incidence of major depression onset at 3-month follow-up was 4% for Change Ahead participants versus 13% (difference ns). Change Ahead appears highly feasible and showed positive indications of reduced acute phase depressive symptoms and MDD onset relative to a minimal intervention control in this initial pilot. Given the brevity of the intervention, its apparent feasibility, and the lack of evidence-based depression prevention programs for college students, continued evaluation of Change Ahead appears warranted. Copyright © 2016 Elsevier Ltd. All rights reserved.
Gold, Christian; Saarikallio, Suvi; Crooke, Alexander Hew Dale; McFerran, Katrina Skewes
Music forms an important part of the lives and identities of adolescents and may have positive or negative mental health implications. Music therapy can be effective for mental disorders such as depression, but its preventive potential is unknown. The aim of this study was to examine whether group music therapy (GMT) is an effective intervention for young people who may be at risk of developing mental health problems, as indicated via unhealthy music use. The main question was whether GMT can reduce unhealthy uses of music and increase potentials for healthy uses of music, compared to self-directed music listening (SDML). We were also interested in effects of GMT on depressive symptoms, psychosocial well-being, rumination, and reflection. In an exploratory cluster-randomized trial in Australian schools, 100 students with self-reported unhealthy music use were invited to GMT (weekly sessions over 8 weeks) or SDML. Changes in the Healthy-Unhealthy Music Scale (HUMS) and mental health outcomes were measured over 3 months. Both interventions were well accepted. No effects were found between GMT and SDML (all p > 0.05); both groups tended to show small improvements over time. Younger participants benefited more from GMT, and older ones more from SDML (p = 0.018). GMT was associated with similar changes as SDML. Further research is needed to improve the processes of selecting participants for targeted interventions; to determine optimal dosage; and to provide more reliable evidence of effects of music-based interventions for adolescents.
Krogh, Jesper; Saltin, Bengt; Gluud, Christian
OBJECTIVE: To assess the benefit and harm of exercise training in adults with clinical depression. METHOD: The DEMO trial is a randomized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007. Patients were referred from general practitioners...... or psychiatrists and were eligible if they fulfilled the International Classification of Diseases, Tenth Revision, criteria for unipolar depression and were aged between 18 and 55 years. Patients (N = 165) were allocated to supervised strength, aerobic, or relaxation training during a 4-month period. The primary...... repetition maximum for chest press increased by a mean (95% CI) of 4.0 kg (0.8 to 7.2; p = .014) in the strength training group versus the relaxation group, and maximal oxygen uptake increased by 2.7 mL/kg/min (1.2 to 4.3; p = .001) in the aerobic group versus the relaxation group. At 4 months, the mean...
Slagsvold, Jens Erik, E-mail: Jens.Erik.Slagsvold@stolav.no [Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); Viset, Trond [Department of Pathology, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); Wibe, Arne [Institute of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim (Norway); Department of Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); Kaasa, Stein [Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); European Palliative Care Research Center, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim (Norway); Widmark, Anders [Department of Radiation Sciences, Cancercentrum, Umeå (Sweden); Lund, Jo-Åsmund [Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); European Palliative Care Research Center, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim (Norway)
Purpose: To investigate long-term changes in the rectal mucosa after curative external beam radiation therapy in the treatment of prostate cancer. Methods and Materials: In the Scandinavian Prostate Cancer Group 7 trial, 880 men with locally advanced prostate cancer were randomized to hormonal therapy alone versus hormonal therapy plus radiation therapy to 70 Gy. A subcohort from this trial being randomized at our center (n=178) was invited to a study on late anorectal side effects during 2003-2005, approximately 5 years after treatment, including measuring health-reported quality of life and physician-assessed toxicity score by the Late Effects Normal Tissue Task Force/Subjective, Objective, Management, Analytic (LENT/SOMA) and European Organization for Research and Treatment of Cancer/Radiation Therapy Oncology Group score. Sixty-seven patients had a rectal mucosa biopsy. Sixty-four biopsies were included in the final analysis, of which 33 patients were randomized to hormonal treatment and 31 to hormonal treatment plus radiation therapy. The presence of fibrosis, number of capillaries, and lymphocyte infiltration was then evaluated by light microscopy. Results: The group receiving radiation therapy had significantly higher LENT/SOMA and function/bother scale scores than the group that only received hormonal treatment, but there was no significant difference in the presence of fibrosis, ectasia, number of capillaries in the lamina propria, or lymphocyte infiltration between the groups. Conclusion: Radiation therapy to 70 Gy to the prostate does not induce long-term microscopic mucosal changes in the rectum 5 years after treatment. This is in contrast to the general assumption that structural changes, including fibrosis, seen after radiation therapy include the mucosa. We speculate that the main late effects of radiation therapy on the structure of the rectum are located in the deeper layers of the rectal wall than the mucosa.
Beauchamp, Mark R; Harden, Samantha M; Wolf, Svenja A; Rhodes, Ryan E; Liu, Yan; Dunlop, William L; Schmader, Toni; Sheel, Andrew W; Zumbo, Bruno D; Estabrooks, Paul A
Physical activity has health benefits across the lifespan, yet only 13 % of Canadian older adults are sufficiently active. Results from a number of observational studies indicate that adults display positive preferences for exercising with others of a similar age and same gender, and that intra-group age- and gender-similarity are associated with elevated exercise adherence. However, research has yet to experimentally examine the extent to which intra-group age- and gender-related similarity affect exercise adherence behaviors. The GrOup-based physical Activity for oLder adults (GOAL) trial is a three-arm randomized control trial that will examine the efficacy of two different group-based exercise programs for older adults (informed by the tenets of self-categorization theory) in relation to a standard group-based exercise program. Within this manuscript we outline the design and proposed evaluation of the GOAL trial. The first arm is comprised of exercise groups made up of participants of a similar-age and of the same gender; the second arm consists of groups with similar-aged mixed gender participants; the control arm is comprised of mixed-aged mixed gender participants. We aim to compare the adherence rates of participants across conditions, as well as potential moderation effects and mediating mechanisms. Results from this trial will inform intervention designs to improve the exercise adherence behaviors of older adult. At a systems-level, should support be derived for the efficacy of the interventions tested in this trial, changing group composition (i.e., age, gender) represents a feasible program adaptation for physical activity centers. ClinicalTrials.gov # NCT02023632 . Registered December 13, 2013.
Finch, C; Lloyd, D; Elliott, B
Knee injuries are a major injury concern for Australian Football players and participants of many other sports worldwide. There is increasing evidence from laboratory and biomechanically focused studies about the likely benefit of targeted exercise programmes to prevent knee injuries. However, there have been few international studies that have evaluated the effectiveness of such programmes in the real-world context of community sport that have combined epidemiological, behavioural and biomechanical approaches. To implement a fully piloted and tested exercise training intervention to reduce the number of football-related knee injuries. In so doing, to evaluate the intervention's effectiveness in the real-world context of community football and to determine if the underlying neural and biomechanical training adaptations are associated with decreased risk of injury. Adult players from community-level Australian Football clubs in two Australian states over the 2007-08 playing seasons. A group-clustered randomised controlled trial with teams of players randomly allocated to either a coach-delivered targeted exercise programme or usual behaviour (control). Epidemiological component: field-based injury surveillance and monitoring of training/game exposures. Behavioural component: evaluation of player and coach attitudes, knowledge, behaviours and compliance, both before and after the intervention is implemented. Biomechanical component: biomechanical, game mobility and neuromuscular parameters assessed to determine the fundamental effect of training on these factors and injury risk. The rate and severity of injury in the intervention group compared with the control group. Changes, if any, in behavioural components. Process evaluation: coach delivery factors and likely sustainability.
Full Text Available Abstract Background Photodegradation of certain vitamins such as riboflavins, carotinoids, tocopherol, and folate has been well-documented. Previous observations suggest that ultraviolet (UV radiation may cause folate deficiency. This is of great importance since folate deficiency is also known to be linked with the development of neural tube defects. To investigate the influence of UVA radiation on serum folate levels in vivo, we conducted a two-group randomised controlled trial on healthy subjects. Material and methods Twenty-four healthy volunteers with skin type II were enrolled into the study. Eight volunteers of the study population were randomly assigned to the control group. UVA irradiation was administered with an air-conditioned sunbed. Blood samples were taken from all volunteers at baseline (T1, 30 min after the first UVA exposure (T2, and at the end of the study 24 h after the sixth UV exposure (T3. The volunteers had two UVA exposures weekly within three weeks (cumulative UVA dose: 96 J/cm2. Volunteers of the control group had no UVA exposures. Serum folate was analysed with an automated immunoassay system. Results At all times of blood collection the differences between serum folate levels were insignificant (P > 0.05, except of the non-exposed controls at T2 (P 0.05. Conclusions Our data suggest that both single and serial UVA exposures do not significantly influence serum folate levels of healthy subjects. Therefore, neural tube defects claimed to occur after periconceptual UVA exposure are probably not due to UVA induced folate deficiency.
Kääpä, Eeva Helena; Frantsi, Kirsi; Sarna, Seppo; Malmivaara, Antti
A randomized trial. To evaluate the effectiveness of a semi-intensive multidisciplinary rehabilitation for patients with chronic low back pain in an outpatient setting. Systematic reviews have shown that there is strong evidence that intensive multidisciplinary treatment (>100 hours), which includes functional restoration, improves function among chronic patients with low back pain, and moderate evidence that it reduces pain but contradictory evidence regarding improvement of working ability. However, there is paucity of data whether semi-intensive outpatient multidisciplinary rehabilitation in groups is more effective than individual physiotherapy. A total of 120 women employed as healthcare and social care professionals with nonspecific chronic low back pain were recruited from two occupational healthcare centers. The patients were randomized into two intervention programs. Multidisciplinary rehabilitation (n = 59) was conducted in groups and comprised of physical training, workplace interventions, back school, relaxation training, and cognitive-behavioral stress management methods for 70 hours. The individual physiotherapy (n = 61) included physical exercise and passive treatment methods administered for 10 hours. Main outcome measures were: back pain and sciatic pain intensity, disability, sick leaves, healthcare consumption, symptoms of depression, and beliefs of working ability after 2 years. There were no statistically significant differences between the two treatment groups in main outcome measures just after rehabilitation, at 6-, at 12-, or 24-month follow-up. In both intervention arms, however, the before-and-after comparison showed favorable effects, and the effects were still maintained at 2 years follow-up. The results of this study indicate that semilight outpatient multidisciplinary rehabilitation program for female chronic low back pain patients does not offer incremental benefits when compared with rehabilitation carried out by a physiotherapist
van de Glind, I; Bunn, C; Gray, C M; Hunt, K; Andersen, E; Jelsma, J; Morgan, H; Pereira, H; Roberts, G; Rooksby, J; Røynesdal, Ø; Silva, M; Sorensen, M; Treweek, S; van Achterberg, T; van der Ploeg, H; van Nassau, F; Nijhuis-van der Sanden, M; Wyke, S
EuroFIT is a gender-sensitised, health and lifestyle program targeting physical activity, sedentary time and dietary behaviours in men. The delivery of the program in football clubs, led by the clubs' community coaches, is designed to both attract and engage men in lifestyle change through an interest in football or loyalty to the club they support. The EuroFIT program will be evaluated in a multicentre pragmatic randomised controlled trial (RCT), for which ~1000 overweight men, aged 30-65 years, will be recruited in 15 top professional football clubs in the Netherlands, Norway, Portugal and the UK. The process evaluation is designed to investigate how implementation within the RCT is achieved in the various football clubs and countries and the processes through which EuroFIT affects outcomes. This mixed methods evaluation is guided by the Medical Research Council (MRC) guidance for conducting process evaluations of complex interventions. Data will be collected in the intervention arm of the EuroFIT trial through: participant questionnaires (n = 500); attendance sheets and coach logs (n = 360); observations of sessions (n = 30); coach questionnaires (n = 30); usage logs from a novel device for self-monitoring physical activity and non-sedentary behaviour (SitFIT); an app-based game to promote social support for physical activity outside program sessions (MatchFIT); interviews with coaches (n = 15); football club representatives (n = 15); and focus groups with participants (n = 30). Written standard operating procedures are used to ensure quality and consistency in data collection and analysis across the participating countries. Data will be analysed thematically within datasets and overall synthesis of findings will address the processes through which the program is implemented in various countries and clubs and through which it affects outcomes, with careful attention to the context of the football club. The process evaluation will
Hänseler, E; Vonderschmitt, D; Haeckel, R; Römer, M; Collombel, C; Goudable, J; Pourcher, E
The Clinical Chemistry Analyzer Dimension 380 manufactured by Du Pont de Nemours was tested in a multicentre evaluation according to the guide-lines of the European Committee for Clinical Laboratory Standards (ECCLS) and in part to the protocol of the Société Française de Biologie Clinique (SFBC). The instrument and the reagents were evaluated as a system, since both reagents and reagent cartridges are specifically designed for the instrument. Fourteen analytes including electrolytes, substrates and enzymes were tested. The evaluators summarized their experience as follows: 1. All parameters tested yield results comparable to established procedures. 2. Very good performance of the ion-selective-electrode unit. 3. The imprecision data of the system are, for most parameters, between 1 and 4% CV and thus equal to or better than those of the instruments compared. 4. No reagent or sample carry-over was detected after a minor modification of the instrument. 5. The linearity of Dimension test methods in general covers the range stated by the manufacturer. 6. Very good stability of the calibration curves (up to 2 months). 7. Good practicability of the whole system, including handling of reagents and a very user-friendly software.
Okely, Anthony D; Lubans, David R; Morgan, Philip J; Cotton, Wayne; Peralta, Louisa; Miller, Judith; Batterham, Marijka; Janssen, Xanne
Slowing the decline in participation in physical activity among adolescent girls is a public health priority. This study reports the outcomes from a multi-component school-based intervention (Girls in Sport), focused on promoting physical activity among adolescent girls. Group randomized controlled trial in 24 secondary schools (12 intervention and 12 control). Assessments were conducted at baseline (2009) and at 18 months post-baseline (2010). The setting was secondary schools in urban, regional and rural areas of New South Wales, Australia. All girls in Grade 8 in 2009 who attended these schools were invited to participate in the study (N = 1769). Using a Health Promoting Schools and Action Learning Frameworks, each school formed a committee and developed an action plan for promoting physical activity among Grade 8 girls. The action plan incorporated strategies in three main areas - i) the formal curriculum, ii) school environment, and iii) home/school/community links - based on the results of formative data from target girls and staff and on individual needs of the school. A member of the research team supported each school throughout the intervention. The main outcome measure was accelerometer-derived total physical activity (TPA) spent in physical activity. Data were analyzed from December 2011 to March 2012. 1518 girls (mean age 13.6y ±0.02) were assessed at baseline. There was a significant decline in TPA from baseline to 18-month follow-up with no differences between girls in the intervention and control schools. Only one-third of schools (4/12) implemented the intervention as per their action plan. Per-protocol analyses on these schools revealed a smaller decline in percentage of time spent in MVPA among girls in the intervention group (adjusted difference 0.5%, 95% CI = -0.01, 0.99, P = 0.05). The Girls in Sport intervention was not effective in reducing the decline in physical activity among adolescent girls. Lack of implementation by most
Full Text Available Anne G Vinsnes1, Jorunn L Helbostad2, Signe Nyrønning3, Gene E Harkless1,4, Randi Granbo5, Arnfinn Seim61Faculty of Nursing, Sør-Trøndelag University College, 2Department of Neuroscience, Norwegian University of Science and Technology, 3Søbstad Community Hospital and Teaching Nursing Home, Trondheim, Norway; 4University of New Hampshire, College of Health and Social Services, Nursing Faculty, Durham, New Hampshire, USA; 5Department of Physiotherapy, Sør-Trøndelag University College, 6Department of Public Health and General Practice, Norwegian University of Science and Technology, Trondheim, NorwayBackground: Residents in nursing homes (NHs are often frail older persons who have impaired physical activity. Urinary incontinence (UI is a common complaint for residents in NHs. Reduced functional ability and residence in NHs are documented to be risk factors for UI.Objective: To investigate if an individualized training program designed to improve activity of daily living (ADL and physical capacity among residents in nursing homes has any impact on UI.Materials and methods: This randomized controlled trial was a substudy of a Nordic multicenter study. Participants had to be >65 years, have stayed in the NH for more than 3 months and in need of assistance in at least one ADL. A total of 98 residents were randomly allocated to either a training group (n = 48 or a control group (n = 50 after baseline registrations. The training program lasted for 3 months and included accommodated physical activity and ADL training. Personal treatment goals were elicited for each subject. The control group received their usual care. The main outcome measure was UI as measured by a 24-hour pad-weighing test. There was no statistically significant difference between the groups on this measure at baseline (P = 0.15. Changes were calculated from baseline to 3 months after the end of the intervention.Results: Altogether, 68 participants were included in the analysis
Langdon, Peter E; Murphy, Glynis H; Wilson, Edward; Shepstone, Lee; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra
Introduction A number of studies have established that children, adolescents and adults with Asperger syndrome (AS) and high functioning autism (HFA) have significant problems with anxiety. Cognitive behavioural therapy (CBT) is an effective treatment for anxiety in a variety of clinical populations. There is a growing interest in exploring the effectiveness of CBT for people with AS who have mental health problems, but currently there are no known clinical trials involving adults with AS or HFA. Studies with children who have AS have reported some success. The current study aims to examine whether modified group CBT for clinically significant anxiety in an AS population is likely to be efficacious. Methods and analysis This study is a randomised, single-blind crossover trial. At least 36 individuals will be recruited and randomised into a treatment arm or a waiting-list control arm. During treatment, individuals will receive 3 sessions of individual CBT, followed by 21 sessions of group CBT. Primary outcome measures focus on anxiety. Secondary outcome measures focus on everyday social and psychiatric functioning, additional measures of anxiety and fear, depression, health-related quality of life and treatment cost. Assessments will be administered at pregroup and postgroup and at follow-up by researchers who are blinded to group allocation. The trial aims to find out whether or not psychological treatments for anxiety can be adapted and used to successfully treat the anxiety experienced by people with AS. Furthermore, we aim to determine whether this intervention represents good value for money. Ethics and dissemination The trial received a favourable ethical opinion from a National Health Service (NHS) Research Ethics Committee. All participants provided written informed consent. Findings will be shared with all trial participants, and the general public, as well as the scientific community. Trial Registration ISRCTN 30265294 (DOI: 10.1186/ISRCTN30265294), UKCRN
Jensen, Rikke Beck; Thankamony, Ajay; O'Connell, Susan M; Kirk, Jeremy; Donaldson, Malcolm; Ivarsson, Sten-A; Söder, Olle; Roche, Edna; Hoey, Hilary; Dunger, David B; Juul, Anders
Short children born small for gestational age (SGA) are treated with a GH dose based on body size, but treatment may lead to high levels of IGF1. The objective was to evaluate IGF1 titration of GH dose in contrast to current dosing strategies. In the North European Small-for-Gestational-Age Study (NESGAS), 92 short pre-pubertal children born SGA were randomised after 1 year of high-dose GH treatment (67 μg/kg per day) to three different regimens: high dose (67 μg/kg per day), low dose (35 μg/kg per day) or IGF1 titration. The average dose during the second year of the randomised trial did not differ between the IGF1 titration group (38 μg/kg per day, s.d. 0.019) and the low-dose group (35 μg/kg per day, s.d. 0.002; P=0.46), but there was a wide variation in the IGF1 titration group (range 10-80 μg/kg per day). The IGF1 titration group had significantly lower height gain (0.17 SDS, s.d. 0.18) during the second year of the randomised trial compared with the high-dose group (0.46 SDS, s.d. 0.25), but not significantly lower than the low-dose group (0.23 SDS, s.d. 0.15; P=0.17). The IGF1 titration group had lower IGF1 levels after 2 years of the trial (mean 1.16, s.d. 1.24) compared with both the low-dose (mean 1.76, s.d. 1.48) and the high-dose (mean 2.97, s.d. 1.63) groups. IGF1 titration of GH dose in SGA children proved less effective than current dosing strategies. IGF1 titration resulted in physiological IGF1 levels with a wide range of GH dose and a poorer growth response, which indicates the role of IGF1 resistance and highlights the heterogeneity of short SGA children. © 2014 European Society of Endocrinology.
Lindström, D; Sundberg-Petersson, I; Adami, J
If a patient agrees to take part in a randomised trial it is reasonable to presume that the patient would prefer to be allocated into the intervention. This study's aim was to investigate how patients react after they have been randomised into control group.......If a patient agrees to take part in a randomised trial it is reasonable to presume that the patient would prefer to be allocated into the intervention. This study's aim was to investigate how patients react after they have been randomised into control group....
Baschali, Aristea; Tsakalidou, Effie; Kyriacou, Adamantini; Karavasiloglou, Nena; Matalas, Antonia-Leda
Fermented beverages hold a long tradition and contribution to the nutrition of many societies and cultures worldwide. Traditional fermentation has been empirically developed in ancient times as a process of raw food preservation and at the same time production of new foods with different sensorial characteristics, such as texture, flavour and aroma, as well as nutritional value. Low-alcoholic fermented beverages (LAFB) and non-alcoholic fermented beverages (NAFB) represent a subgroup of fermented beverages that have received rather little attention by consumers and scientists alike, especially with regard to their types and traditional uses in European societies. A literature review was undertaken and research articles, review papers and textbooks were searched in order to retrieve data regarding the dietary role, nutrient composition, health benefits and other relevant aspects of diverse ethnic LAFB and NAFB consumed by European populations. A variety of traditional LAFB and NAFB consumed in European regions, such as kefir, kvass, kombucha and hardaliye, are presented. Milk-based LAFB and NAFB are also available on the market, often characterised as 'functional' foods on the basis of their probiotic culture content. Future research should focus on elucidating the dietary role and nutritional value of traditional and 'functional' LAFB and NAFB, their potential health benefits and consumption trends in European countries. Such data will allow for LAFB and NAFB to be included in national food composition tables.
Schaap, M. M.; Kunst, A. E.; Leinsalu, M.; Regidor, E.; Ekholm, O.; Dzurova, D.; Helmert, U.; Klumbiene, J.; Santana, P.; Mackenbach, J. P.
BACKGROUND: Recently a scale was introduced to quantify the implementation of tobacco control policies at country level. Our study used this scale to examine the potential impact of these policies on quit ratios in European countries. Special attention was given to smoking cessation among lower
Branco, Jaime C; Zachrisson, Olof; Perrot, Serge
This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population.......This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population....
Pinxten, Wim; Dierickx, Kris; Nys, Herman
The involvement of minors in clinical research is inevitable to catch up with the lack of drugs labeled for pediatric use. To encourage the responsible conduct of pediatric clinical trials in the EU, an extensive legal framework has been developed over the past decade in which the practical, ethical, legal, social, and commercial issues in pediatric research are addressed. In this article, the European legal framework surrounding pediatric clinical trials is analyzed from the perspective of the major ethical concerns in pediatric research. The four principles of biomedical ethics will be used as a conceptual framework (1) to map the ethical issues addressed in the European legal framework, (2) to study how these issues are commonly handled in competent adults, (3) to detect workability problems of these paradigmatic approaches in the specific setting of pediatric research, and (4) to illustrate the strong urge to differentiate, specify, or adjust these paradigmatic approaches to guarantee their successful operation in pediatric research. In addition, a concise comparative analysis of the European regulation will be made. To conclude our analysis, we integrate our findings in the existing ethical discussions on issues specific to pediatric clinical research.
Noelle R Leonard
Full Text Available We investigated the impact of cognitive behavioral therapy and mindfulness training (CBT/MT on attentional task performance in incarcerated adolescents. Attention is a cognitive system necessary for managing cognitive demands and regulating emotions. Yet persistent and intensive demands, such as those experienced during high-stress intervals like incarceration and the events leading to incarceration, may deplete attention resulting in cognitive failures, emotional disturbances, and impulsive behavior. We hypothesized that CBT/MT may mitigate these deleterious effects of high stress and protect against degradation in attention over the high-stress interval of incarceration. Using a group randomized controlled trial design, we randomly assigned dormitories of incarcerated youth, ages 16 to 18, to a CBT/MT intervention (youth n = 147 or an active control intervention (youth n = 117. Both arms received approximately 750 minutes of intervention in a small-group setting over a 3-5 week period. Youth in the CBT/MT arm also logged the amount of out-of-session time spent practicing MT exercises. The Attention Network Test was used to index attentional task performance at baseline and 4 months post-baseline. Overall, task performance degraded over time in all participants. The magnitude of performance degradation was significantly less in the CBT/MT vs. control arm. Further, within the CBT/MT arm, performance degraded over time in those with no outside-of-class practice time, but remained stable over time in those who practiced mindfulness exercises outside of the session meetings. Thus, these findings suggest that sufficient CBT/MT practice may protect against functional attentional impairments associated with high-stress intervals. Keywords: adolescent development, incarcerated adolescents, detained adolescents, stress, attention, mindfulness meditation.
Kruse, A Y; Kjaergard, L L; Krogsgaard, K
To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomized clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about...... the total attitude score (4.8 points) and the randomized clinical trials attitude subscale score (1.8 points). In conclusion, written information significantly improved outpatients' knowledge about and attitude toward randomized clinical trials. Detailed rather than brief information was more effective...
Full Text Available Abstract Background Studies on different methods to supplement the traditional informed consent process have generated conflicting results. This study was designed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling, based on the hypothesis that group counseling would foster discussion among potential participants and enhance their understanding of the informed consent. Methods Parents of children participating in a trial of nutritional supplementation were randomized to receive either group counseling or individual counseling prior to administration of the informed consent. To assess the participant's comprehension, a structured questionnaire was administered approximately 48-72 hours afterwards by interviewers who were blinded to the allocation group of the respondents. Results A total of 128 parents were recruited and follow up was established with 118 (90.2% for the study. All respondents were aware of their child's participation in a research study and the details of sample collection. However, their understanding of study purpose, randomization and withdrawal was poor. There was no difference in comprehension of key elements of the informed consent between the intervention and control arm. Conclusions The results suggest that the group counseling might not influence the overall comprehension of the informed consent process. Further research is required to devise better ways of improving participants' understanding of randomization in clinical trials. Trial Registration Clinical Trial Registry - India (CTRI: CTRI/2009/091/000612
Dowlatabadi, Mohammad Mehdi; Ahmadi, Seyed Mojtaba; Sorbi, Mohammad Hossein; Beiki, Omid; Razavi, Tayebeh Khademeh; Bidaki, Reza
Background Breast cancer is one of the most prevalent cancers in women in the world. It causes fear, despair, and takes a tremendous toll on psychological status. Objective To determine the effectiveness of group positive psychotherapy on the depression and happiness of breast cancer patients. Methods This randomized controlled trial was conducted with 42 breast cancer patients in The Oncology Center at Kermanshah, Iran in 2015. The Data were gathered before intervention and ten weeks afterwards. The data were collected using Beck’s Depression Inventory (BDI-II) and Oxford’s happiness Inventory (OHI). The data were analyzed by SPSS-16, Kolmogorov-Smirnov (K-S), chi-squared, and multivariate analysis of covariance (MANCOVA). Results The results showed a significant reduction in the depression of the group on positive psychotherapy compared with the control group. Also the positive psychotherapy group experienced a significant increase in the patients’ happiness, while there was no significant increase in the control group. Conclusion The results of this research showed the effectiveness of positive psychotherapy on the reduction of mental pressure and the improvement of the mental status of breast cancer patients. This economical therapy can be used to increase patients’ psychological health. Clinical Trial Registration The trial was registered at the Iranian Registry of Clinical Trials (IRST) with the identification number IRCT2013101410063N4. Funding The authors received financial support for the research from Kermanshah University of Medical Sciences. PMID:27123227
Gómez-Veiga, F; Rodríguez-Antolín, A; Miñana, B; Hernández, C; Suárez, J F; Fernández-Gómez, J M; Unda, M; Burgos, J; Alcaraz, A; Rodríguez, P; Medina, R; Castiñeiras, J; Moreno, C; Pedrosa, E; Cózar, J M
To assess the adherence to European Association of Urology (EAU) guidelines in the management of prostate cancer (PCa) in Spain. Epidemiological, population-based, study including a national representative sample of 3,918 incident patients with histopathological confirmation during 2010; 95% of the patient's sample was followed up for at least one year. Diagnosis along with treatment related variables (for localized PCa -low, intermediate, high and locally-advanced by D'Amico risk stratification) was recorded. Differences between groups were tested with Chi-squared and Kruskal-Wallis tests. Mean (SD) age of PCa patients was 68.48 (8.18). Regarding diagnostic by biopsy procedures, 64.56% of all patients had 8-12 cores in first biopsy and 46.5% of the patients over 75 years, with PSA<10ng/mL were biopsied. Staging by Computer Tomography (CT) or Bone Scan (BS) was used for determining tumor extension in 60.09% of high-risk cases and was applied differentially depending on patients' age; 3,293 (84.05%) patients received a treatment for localized PCa. Radical prostatectomy was done in 1,277 patients and 206 out of these patients also had a lymphadenectomy, being 4.64% low-risk, 22.81% intermediate-risk and 36.00% high-risk patients; 86.08% of 1,082 patients who had radiotherapy were treated with 3D or IMRT and 35.77% received a dose ≥75Gy; 419 patients were treated with brachytherapy (BT): 54.81% were low-risk patients, 22.84% intermediate-risk and 12.98% high-risk. Hormonotherapy (HT, n=521) was applied as single therapy in 9.46% of low-risk and 17.92% of intermediate-risk patients. Additionally, HT was combined with RT in 14.34% of lower-risk patients and 58.26% of high-risk patients, and 67.19% low-intermediate risk with RT and/or BT received neoadjuvant/concomitant/adjuvant HT. Finally, 83.75% of high-risk patients undergoing RT and/or BT also received HT. Although EAU guidelines for PCa management are easily available in Europe, the adherence to their
Cardiovascular pre-participation screening of young competitive athletes for prevention of sudden death: proposal for a common European protocol. Consensus Statement of the Study Group of Sport Cardiology of the Working Group of Cardiac Rehabilitation and Exercise Physiology and the Working Group of Myocardial and Pericardial Diseases of the European Society of Cardiology.
Corrado, Domenico; Pelliccia, Antonio; Bjørnstad, Hans Halvor; Vanhees, Luc; Biffi, Alessandro; Borjesson, Mats; Panhuyzen-Goedkoop, Nicole; Deligiannis, Asterios; Solberg, Erik; Dugmore, Dorian; Mellwig, Klaus P; Assanelli, Deodato; Delise, Pietro; van-Buuren, Frank; Anastasakis, Aris; Heidbuchel, Hein; Hoffmann, Ellen; Fagard, Robert; Priori, Silvia G; Basso, Cristina; Arbustini, Eloisa; Blomstrom-Lundqvist, Carina; McKenna, William J; Thiene, Gaetano
The 1996 American Heart Association consensus panel recommendations stated that pre-participation cardiovascular screening for young competitive athletes is justifiable and compelling on ethical, legal, and medical grounds. The present article represents the consensus statement of the Study Group on Sports Cardiology of the Working Group on Cardiac Rehabilitation and Exercise Physiology and the Working Group on Myocardial and Pericardial diseases of the European Society of Cardiology, which comprises cardiovascular specialists and other physicians from different European countries with extensive clinical experience with young competitive athletes, as well as with pathological substrates of sudden death. The document takes note of the 25-year Italian experience on systematic pre-participation screening of competitive athletes and focuses on relevant issues, mostly regarding the relative risk, causes, and prevalence of sudden death in athletes; the efficacy, feasibility, and cost-effectiveness of population-based pre-participation cardiovascular screening; the key role of 12-lead ECG for identification of cardiovascular diseases such as cardiomyopathies and channelopathies at risk of sudden death during sports; and the potential of preventing fatal events. The main purpose of the consensus document is to reinforce the principle of the need for pre-participation medical clearance of all young athletes involved in organized sports programmes, on the basis of (i) the proven efficacy of systematic screening by 12-lead ECG (in addition to history and physical examination) to identify hypertrophic cardiomyopathy-the leading cause of sports-related sudden death-and to prevent athletic field fatalities; (ii) the potential screening ability in detecting other lethal cardiovascular diseases presenting with ECG abnormalities. The consensus document recommends the implementation of a common European screening protocol essentially based on 12-lead ECG.
Ejlertsen, Bent; Offersen, Birgitte Vrou; Overgaard, Jens
treatments. These trials have been instrumental to establish standards for the treatment of early breast cancer. Methods: The DBCG 82 trials had a global impact by documenting that the significant gain in loco-regional recurrence from postmastectomy radiation added to systemic therapy was associated......Background: Over the past 40 years the Danish Breast Cancer Cooperative Group (DBCG) has made significant contributions to improve outcome and to make treatment of patients with early breast cancer more tolerable through nationwide and international trials evaluating loco-regional and systemic...... by the DBCG 40 years ago on tamoxifen and cyclophosphamide based chemotherapy became instrumental for the development of adjuvant systemic therapy not only due to their positive results but by sharing these important data with other members of the Early Breast Cancer Trialist’ Collaborative Group (EBCTCG...
Langdon, Peter E; Murphy, Glynis H; Wilson, Edward; Shepstone, Lee; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra
A number of studies have established that children, adolescents and adults with Asperger syndrome (AS) and high functioning autism (HFA) have significant problems with anxiety. Cognitive behavioural therapy (CBT) is an effective treatment for anxiety in a variety of clinical populations. There is a growing interest in exploring the effectiveness of CBT for people with AS who have mental health problems, but currently there are no known clinical trials involving adults with AS or HFA. Studies with children who have AS have reported some success. The current study aims to examine whether modified group CBT for clinically significant anxiety in an AS population is likely to be efficacious. This study is a randomised, single-blind crossover trial. At least 36 individuals will be recruited and randomised into a treatment arm or a waiting-list control arm. During treatment, individuals will receive 3 sessions of individual CBT, followed by 21 sessions of group CBT. Primary outcome measures focus on anxiety. Secondary outcome measures focus on everyday social and psychiatric functioning, additional measures of anxiety and fear, depression, health-related quality of life and treatment cost. Assessments will be administered at pregroup and postgroup and at follow-up by researchers who are blinded to group allocation. The trial aims to find out whether or not psychological treatments for anxiety can be adapted and used to successfully treat the anxiety experienced by people with AS. Furthermore, we aim to determine whether this intervention represents good value for money. The trial received a favourable ethical opinion from a National Health Service (NHS) Research Ethics Committee. All participants provided written informed consent. Findings will be shared with all trial participants, and the general public, as well as the scientific community. ISRCTN 30265294 (DOI: 10.1186/ISRCTN30265294), UKCRN 8370.
Westine, Carl; Spybrook, Jessaca
The capacity of the field to conduct power analyses for group randomized trials (GRTs) of educational interventions has improved over the past decade (Authors, 2009). However, a power analysis depends on estimates of design parameters. Hence it is critical to build the empirical base of design parameters for GRTs across a variety of outcomes and…
Hoogenhout, Esther; De Groot, Renate; Van der Elst, Wim; Jolles, Jelle
Hoogenhout, E. M., De Groot, R. H. M., Van der Elst, W., Jolles J. (2012). Effects of a comprehensive educational group intervention in older women with cognitive complaints: a randomized controlled trial. Aging & Mental Health, 16, 135-144. doi:10.1080/13607863.2011.598846
Lindström, D; Sundberg-Petersson, I; Adami, J
If a patient agrees to take part in a randomised trial it is reasonable to presume that the patient would prefer to be allocated into the intervention. This study's aim was to investigate how patients react after they have been randomised into control group....
Full Text Available Abstract Background The aim was to compare effectiveness of group versus individual sessions of physiotherapy in terms of symptoms, quality of life, and costs, and to investigate the effect of patient preference on uptake and outcome of treatment. Methods A pragmatic, multi-centre randomised controlled trial in five British National Health Service physiotherapy departments. 174 women with stress and/or urge incontinence were randomised to receive treatment from a physiotherapist delivered in a group or individual setting over three weekly sessions. Outcome were measured as Symptom Severity Index; Incontinence-related Quality of Life questionnaire; National Health Service costs, and out of pocket expenses. Results The majority of women expressed no preference (55% or preference for individual treatment (36%. Treatment attendance was good, with similar attendance with both service delivery models. Overall, there were no statistically significant differences in symptom severity or quality of life outcomes between the models. Over 85% of women reported a subjective benefit of treatment, with a slightly higher rating in the individual compared with the group setting. When all health care costs were considered, average cost per patient was lower for group sessions (Mean cost difference £52.91 95%, confidence interval (£25.82 - £80.00. Conclusion Indications are that whilst some women may have an initial preference for individual treatment, there are no substantial differences in the symptom, quality of life outcomes or non-attendance. Because of the significant difference in mean cost, group treatment is recommended. Trial Registration Trial Registration number: ISRCTN 16772662
Beyer, M; Gerlach, F M; Flies, U; Grol, R; Król, Z; Munck, A; Olesen, F; O'Riordan, M; Seuntjens, L; Szecsenyi, J
Peer review groups (PRGs) and quality circles (QCs) commenced in The Netherlands and have grown to become an important method of quality improvement in primary care in several other European countries. Our aim was to provide an overview of QC/PRG activities and exemplary programmes in European countries. A survey was performed in three consecutive steps by EQuiP (European Working Party on Quality in Family Practice), which is a representative association of experts from 26 European countries. The national representatives initially completed a structured questionnaire documenting the number and objectives of QCs/PRGs, sources of support and special programmes in their countries (step 1). In step 2, these sources were used to extend and validate the expert statements. Step 3 studied paradigmatic initiatives in depth. Step 1 took place in 2000; the response rate was 100% (26 countries). QCs/PRGs were very active in 10 countries; 16 countries showed little or no activity. Participation ranged from quality of care.
EuroEco (European Health Economic Trial on Home Monitoring in ICD Patients): a provider perspective in five European countries on costs and net financial impact of follow-up with or without remote monitoring.
Heidbuchel, Hein; Hindricks, Gerd; Broadhurst, Paul; Van Erven, Lieselot; Fernandez-Lozano, Ignacio; Rivero-Ayerza, Maximo; Malinowski, Klaus; Marek, Andrea; Romero Garrido, Rafael F; Löscher, Steffen; Beeton, Ian; Garcia, Enrique; Cross, Stephen; Vijgen, Johan; Koivisto, Ulla-Maija; Peinado, Rafael; Smala, Antje; Annemans, Lieven
Remote follow-up (FU) of implantable cardiac defibrillators (ICDs) allows for fewer in-office visits in combination with earlier detection of relevant findings. Its implementation requires investment and reorganization of care. Providers (physicians or hospitals) are unsure about the financial impact. The primary end-point of this randomized prospective multicentre health economic trial was the total FU-related cost for providers, comparing Home Monitoring facilitated FU (HM ON) to regular in-office FU (HM OFF) during the first 2 years after ICD implantation. Also the net financial impact on providers (taking national reimbursement into account) and costs from a healthcare payer perspective were evaluated. A total of 312 patients with VVI- or DDD-ICD implants from 17 centres in six EU countries were randomised to HM ON or OFF, of which 303 were eligible for data analysis. For all contacts (in-office, calendar- or alert-triggered web-based review, discussions, calls) time-expenditure was tracked. Country-specific cost parameters were used to convert resource use into monetary values. Remote FU equipment itself was not included in the cost calculations. Given only two patients from Finland (one in each group) a monetary valuation analysis was not performed for Finland. Average age was 62.4 ± 13.1 years, 81% were male, 39% received a DDD system, and 51% had a prophylactic ICD. Resource use with HM ON was clearly different: less FU visits (3.79 ± 1.67 vs. 5.53 ± 2.32; P financial impact on providers [profit of €408 (327-489) vs. €400 (345-455); range for difference (€-104 to 88), NS], but there was heterogeneity among countries, with less profit for providers in the absence of specific remote FU reimbursement (Belgium, Spain, and the Netherlands) and maintained or increased profit in cases where such reimbursement exists (Germany and UK). Quality of life (SF-36) was not different. For all the patients as a whole, FU-related costs for providers are not
European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries.
Kleiboer, Annet; Smit, Jan; Bosmans, Judith; Ruwaard, Jeroen; Andersson, Gerhard; Topooco, Naira; Berger, Thomas; Krieger, Tobias; Botella, Cristina; Baños, Rosa; Chevreul, Karine; Araya, Ricardo; Cerga-Pashoja, Arlinda; Cieślak, Roman; Rogala, Anna; Vis, Christiaan; Draisma, Stasja; van Schaik, Anneke; Kemmeren, Lise; Ebert, David; Berking, Matthias; Funk, Burkhardt; Cuijpers, Pim; Riper, Heleen
Effective, accessible, and affordable depression treatment is of high importance considering the large personal and economic burden of depression. Internet-based treatment is considered a promising clinical and cost-effective alternative to current routine depression treatment strategies such as face-to-face psychotherapy. However, it is not clear whether research findings translate to routine clinical practice such as primary or specialized mental health care. The E-COMPARED project aims to gain knowledge on the clinical and cost-effectiveness of blended depression treatment compared to treatment-as-usual in routine care. E-COMPARED will employ a pragmatic, multinational, randomized controlled, non-inferiority trial in eight European countries. Adults diagnosed with major depressive disorder (MDD) will be recruited in primary care (Germany, Poland, Spain, Sweden, and the United Kingdom) or specialized mental health care (France, The Netherlands, and Switzerland). Regular care for depression is compared to "blended" service delivery combining mobile and Internet technologies with face-to-face treatment in one treatment protocol. Participants will be followed up at 3, 6, and 12 months after baseline to determine clinical improvements in symptoms of depression (primary outcome: Patient Health Questionnaire-9), remission of depression, and cost-effectiveness. Main analyses will be conducted on the pooled data from the eight countries (n = 1200 in total, 150 participants in each country). The E-COMPARED project will provide mental health care stakeholders with evidence-based information and recommendations on the clinical and cost-effectiveness of blended depression treatment. France: ClinicalTrials.gov NCT02542891 . Registered on 4 September 2015; Germany: German Clinical Trials Register DRKS00006866 . Registered on 2 December 2014; The Netherlands: Netherlands Trials Register NTR4962 . Registered on 5 January 2015; Poland: ClinicalTrials.Gov NCT02389660
Outcome of Patients With Recurrent Osteosarcoma Enrolled in Seven Phase II Trials Through Children's Cancer Group, Pediatric Oncology Group, and Children's Oncology Group: Learning From the Past to Move Forward
Krailo, Mark D.; Dang, Ha; Kim, AeRang; Hawkins, Douglas S.; Beaty, Orren; Widemann, Brigitte C.; Zwerdling, Theodore; Bomgaars, Lisa; Langevin, Anne-Marie; Grier, Holcombe E.; Weigel, Brenda; Blaney, Susan M.; Gorlick, Richard; Janeway, Katherine A.
Purpose The use of radiographic response as the primary end point in phase II osteosarcoma trials may limit optimal detection of treatment response because of the calcified tumor matrix. We performed this study to determine if time to progression could be used as an end point for subsequent studies. Patients and Methods We performed a retrospective analysis of outcome for patients with recurrent/refractory osteosarcoma enrolled in one of seven phase II trials conducted by the Children’s Oncology Group and predecessor groups from 1997 to 2007. All trials used RECIST or WHO radiographic response criteria and the primary end point of response rate. The following potential prognostic factors—age, trial, number of prior chemotherapy regimens, sex, and race/ethnicity—were evaluated for their impact on event-free survival (EFS). We used data from a phase II study (AOST0221) of patients with osteosarcoma who were given inhaled granulocyte-macrophage colony-stimulating factor with first pulmonary recurrence who had an EFS as well as biologic end point to determine the historical disease control rate for patients with fully resected disease. Results In each included trial, the drugs tested were determined to be inactive on the basis of radiographic response rates. The EFS for 96 patients with osteosarcoma and measurable disease was 12% at 4 months (95% CI, 6% to 19%). There was no significant difference in EFS across trials according to number of prior treatment regimens or patient age, sex, and ethnicity. The 12-month EFS for the 42 evaluable patients enrolled in AOST0221 was 20% (95% CI, 10% to 34%). Conclusion The EFS was uniformly poor for children with recurrent/refractory osteosarcoma in these single-arm phase II trials. We have now constructed baseline EFS outcomes that can be used as a comparison for future phase II trials for recurrent osteosarcoma. PMID:27400942
Validation of Progression-Free Survival as a Surrogate Endpoint for Overall Survival in Malignant Mesothelioma: Analysis of Cancer and Leukemia Group B and North Central Cancer Treatment Group (Alliance) Trials.
Wang, Xiaofei; Wang, Xiaoyi; Hodgson, Lydia; George, Stephen L; Sargent, Daniel J; Foster, Nate R; Ganti, Apar Kishor; Stinchcombe, Thomas E; Crawford, Jeffrey; Kratzke, Robert; Adjei, Alex A; Kindler, Hedy L; Vokes, Everett E; Pang, Herbert
The aim of this study was to investigate whether progression-free survival (PFS) can be considered a surrogate endpoint for overall survival (OS) in malignant mesothelioma. Individual data were collected from 15 Cancer and Leukemia Group B (615 patients) and 2 North Central Cancer Treatment Group (101 patients) phase II trials. The effects of 5 risk factors for OS and PFS, including age, histology, performance status (PS), white blood cell count, and European Organisation for Research and Treatment of Cancer (EORTC) risk score, were used in the analysis. Individual-level surrogacy was assessed by Kendall's tau through a Clayton bivariate Copula survival (CBCS) model. Summary-level surrogacy was evaluated via the association between logarithms of the hazard ratio (log HR)-log HR OS and log HR PFS -measured in R 2 from a weighted least-square (WLS) regression model and the CBCS model. The median PFS for all patients was 3.0 months (95% confidence interval [CI], 2.8-3.5 months) and the median OS was 7.2 months (95% CI, 6.5-8.0 months). Moderate correlations between PFS and OS were observed across all risk factors at the individual level, with Kendall's tau ranging from 0.46 to 0.47. The summary-level surrogacy varied among risk factors. The Copula R 2 ranged from 0.51 for PS to 0.78 for histology. The WLS R 2 ranged from 0.26 for EORTC and PS to 0.67 for age. The analyses demonstrated low to moderate individual-level surrogacy between PFS and OS. At the summary level, the surrogacy between PFS and OS varied significantly across different risk factors. With a short postprogression survival and a moderate correlation between PFS and OS, there is no evidence that PFS is a valid surrogate endpoint for OS in malignant mesothelioma. The Oncologist 2017;22:189-198 Implications for Practice: For better disease management and for more efficient clinical trial designs, it is important to know if progression-free survival (PFS) is a good surrogate endpoint for overall survival
Johns, David J; Hartmann-Boyce, Jamie; Jebb, Susan A; Aveyard, Paul
Evidence on the effectiveness of behavioral weight management programs often comes from uncontrolled program evaluations. These frequently make the assumption that, without intervention, people will gain weight. The aim of this study was to use data from minimal intervention control groups in randomized controlled trials to examine the evidence for this assumption and the effect of frequency of weighing on weight change. Data were extracted from minimal intervention control arms in a systematic review of multicomponent behavioral weight management programs. Two reviewers classified control arms into three categories based on intensity of minimal intervention and calculated 12-month mean weight change using baseline observation carried forward. Meta-regression was conducted in STATA v12. Thirty studies met the inclusion criteria, twenty-nine of which had usable data, representing 5,963 participants allocated to control arms. Control arms were categorized according to intensity, as offering leaflets only, a single session of advice, or more than one session of advice from someone without specialist skills in supporting weight loss. Mean weight change at 12 months across all categories was -0.8 kg (95% CI -1.1 to -0.4). In an unadjusted model, increasing intensity by moving up a category was associated with an additional weight loss of -0.53 kg (95% CI -0.96 to -0.09). Also in an unadjusted model, each additional weigh-in was associated with a weight change of -0.42 kg (95% CI -0.81 to -0.03). However, when both variables were placed in the same model, neither intervention category nor number of weigh-ins was associated with weight change. Uncontrolled evaluations of weight loss programs should assume that, in the absence of intervention, their population would weigh up to a kilogram on average less than baseline at the end of the first year of follow-up. © 2016 The Authors Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).
Waxmonsky, James G.; Waschbusch, Daniel A.; Belin, Peter; Li, Tan; Babocsai, Lysett; Humphrey, Hugh; Pariseau, Meaghan E.; Babinski, Dara E.; Hoffman, Martin T.; Haak, Jenifer L.; Mazzant, Jessica A.; Fabiano, Gregory A.; Pettit, Jeremy W.; Fallahazad, Negar; Pelham, William E.
Objective Non-episodic irritability is a common and impairing problem, leading to the development of the diagnoses severe mood dysregulation (SMD) and disruptive mood dysregulation disorder (DMDD). No psychosocial therapies have been formally evaluated for either, with medication being the most common treatment. This study examined the feasibility and efficacy of a joint parent–child intervention for SMD. Method Sixty-eight particpants ages 7–12 with attention-deficit/hyperactivity disorder (ADHD) and SMD were randomly assigned to the 11-week therapy or community-based psychosocial treatment. All participants were first stabilized on psychostimulant medication by study physicians. Fifty-six still manifested impairing SMD symptoms and entered the therapy phase. Masked evaluators assessed participants at baseline, midpoint, and endpoint, with therapy participants reassessed 6 weeks later. Results All but two therapy participants attended the majority of sessions (n=29), with families reporting high levels of satisfaction. The primary outcome of change in mood symptoms using the Mood Severity Index (MSI) did not reach significance except in the subset attending the majority of sessions (effect size [ES]=0.53). Therapy was associated with significantly greater improvement in parent-rated irritability (ES=0.63). Treatment effects for irritability but not MSI diminished after therapy stopped. Little impact on ADHD symptoms was seen. Results may not be generalizable to youth with SMD and different comorbidities than seen in this sample of children with ADHD and are limited by the lack of a gold standard for measuring change in SMD symptoms. Conclusion While failing to significantly improve mood symptoms versus community treatment, the integrative therapy was found to be a feasible and efficacious treatment for irritability in participants with SMD and ADHD. Clinical trial registration information Group-Based Behavioral Therapy Combined With Stimulant Medication for
Full Text Available Abstract Background In routine psychiatric treatment most clinicians inquire about indicators of suicide risk, but once the risk is assessed not many clinicians systematically focus on suicidal thoughts. This may reflect a commonly held opinion that once the depressive or anxious symptoms are effectively treated the suicidal symptoms will wane. Consequently, many clients with suicidal thoughts do not receive systematic treatment of their suicidal thinking. There are many indications that specific attention to suicidal thinking is necessary to effectively decrease the intensity and recurrence of suicidal thinking. We therefore developed a group training for patients with suicidal thoughts that is easy to apply in clinical settings as an addition to regular treatment and that explicitly focuses on suicidal thinking. We hypothesize that such an additional training will decrease the frequency and intensity of suicidal thinking. We based the training on cognitive behavioural approaches of hopelessness, worrying, and future perspectives, given the theories of Beck, McLeod and others, concerning the lack of positive expectations characteristic for many suicidal patients. In collaboration with each participant in the training individual positive future possibilities and goals were challenged. Methods/Design We evaluate the effects of our program on suicide ideation (primary outcome measure. The study is conducted in a regular treatment setting with regular inpatients and outpatients representative for Dutch psychiatric treatment settings. The design is a RCT with two arms: TAU (Treatment as Usual versus TAU plus the training. Follow up measurements are taken 12 months after the first assessment. Discussion There is a need for research on the effectiveness of interventions in suicidology, especially RCT's. In our treatment program we combine aspects and interventions that have been proven to be useful in the treatment of suicidal thinking and behavior
Clinical trials update from the European Society of Cardiology-Heart Failure meeting 2015: AUGMENT-HF, TITRATION, STOP-HF, HARMONIZE, LION HEART, MOOD-HF, and renin-angiotensin inhibitors in patients with heart and renal failure.
Pellicori, Pierpaolo; Clark, Andrew L
This article provides an overview on the key trials relevant to the pathophysiology, prevention, and treatment of heart failure (HF) presented at the Heart Failure Association (HFA) of the European Society of Cardiology (ESC) annual meeting held in Seville, Spain in May 2015. Trials reported include AUGMENT-AF (myocardial injections of calcium-alginate hydrogel), a propensity score-matched study of renin-angiotensin system antagonists in patients with HF and severe renal dysfunction, HARMONIZE (sodium zirconium cyclosilicate used to bind potassium), TITRATION, comparing two regimes for introducing LCZ696, STOP-HF, a trial of intramyocardial stromal cell-derived factor-1, MOOD-HF (escitalopram for patients with heart failure and depression), and LION HEART, a trial of intermittent levosimendan therapy. Unpublished reports should be considered as preliminary, since analyses may change in the final publication. © 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology.
Larson, V D; Williams, D W; Henderson, W G; Luethke, L E; Beck, L B; Noffsinger, D; Wilson, R H; Dobie, R A; Haskell, G B; Bratt, G W; Shanks, J E; Stelmachowicz, P; Studebaker, G A; Boysen, A E; Donahue, A; Canalis, R; Fausti, S A; Rappaport, B Z
Numerous studies have demonstrated that hearing aids provide significant benefit for a wide range of sensorineural hearing loss, but no carefully controlled, multicenter clinical trials comparing hearing aid efficacy have been conducted. To compare the benefits provided to patients with sensorineural hearing loss by 3 commonly used hearing aid circuits. Double-blind, 3-period, 3-treatment crossover trial conducted from May 1996 to February 1998. Eight audiology laboratories at Department of Veterans Affairs medical centers across the United States. A sample of 360 patients with bilateral sensorineural hearing loss (mean age, 67.2 years; 57% male; 78.6% white). Patients were randomly assigned to 1 of 6 sequences of linear peak clipper (PC), compression limiter (CL), and wide dynamic range compressor (WDRC) hearing aid circuits. All patients wore each of the 3 hearing aids, which were installed in identical casements, for 3 months. Results of tests of speech recognition, sound quality, and subjective hearing aid benefit, administered at baseline and after each 3-month intervention with and without a hearing aid. At the end of the experiment, patients ranked the 3 hearing aid circuits. Each circuit markedly improved speech recognition, with greater improvement observed for soft and conversationally loud speech (all 52-dB and 62-dB conditions, Phearing aid circuits more frequently (41.6%) than the WDRC (29.8%) and the PC (28.6%) (P =.001 for CL vs both WDRC and PC). Each circuit provided significant benefit in quiet and noisy listening situations. The CL and WDRC circuits appeared to provide superior benefits compared with the PC, although the differences between them were much less than the differences between the aided vs unaided conditions. JAMA. 2000;284:1806-1813.
Hesser, Hugo; Weise, Cornelia; Rief, Winfried; Andersson, Gerhard
The response rates and effects of being placed on a wait-list control condition are well documented in psychiatric populations. Despite the usefulness of such estimates and the frequent use of no-treatment controls in clinical trials for tinnitus, the effect of waiting in a tinnitus trial has not been investigated systematically. The aim of the present study was to quantify the overall effect of wait-list control groups on tinnitus distress. Studies were retrieved via a systematic review of randomised controlled trials of cognitive behaviour therapy for tinnitus distress. Outcomes of psychometrically robust tinnitus-specific measures (Tinnitus Handicap Inventory, Tinnitus Questionnaire, Tinnitus Reaction Questionnaire) from wait-list control groups were quantified using meta-analytic techniques. Percentage of change and standard mean difference effect sizes were calculated using the pre and post wait period. Eleven studies involving 314 wait-list subjects with tinnitus were located. The analysis for a waiting period of 6 to 12 weeks revealed a mean decrease in scores on tinnitus-specific measures of 3% to 8%. Across studies, a statically significant small mean within-group effect size was obtained (Hedges' g=.17). The effects were moderated by methodological quality of the trial, sample characteristics (i.e., age, tinnitus duration), time of the wait-list and how diagnosis was established. Subjects in a tinnitus trial improve in tinnitus distress over a short waiting phase. The effects of waiting are highly variable and depend on the characteristics of the sample and of the trial. Copyright © 2011 Elsevier Inc. All rights reserved.
Alexander, Brian M; Galanis, Evanthia; Yung, W.K. Alfred; Ballman, Karla V.; Boyett, James M.; Cloughesy, Timothy F.; Degroot, John F.; Huse, Jason T.; Mann, Bhupinder; Mason, Warren; Ingo K Mellinghoff; Mikkelsen, Tom; Mischel, Paul S.; O'Neill, Brian P.; Prados, Michael D.
Glioblastoma is the most common primary brain malignancy and is associated with poor prognosis despite aggressive local and systemic therapy, which is related to a paucity of viable treatment options in both the newly diagnosed and recurrent settings. Even so, the rapidly increasing number of targeted therapies being evaluated in oncology clinical trials offers hope for the future. Given the broad range of possibilities for future trials, the Brain Malignancy Steering Committee convened a cli...
Lutsep, Helmi L
Secondary stroke prevention is an important goal of poststroke patient treatment. Various pharmacologic approaches have been advocated, but the relative efficacy and safety of these regimens has remained the subject of much debate. Recently released data from the European/Australasian Stroke Prevention in Reversible Ischemia Trial (ESPRIT) indicated that combination therapy with aspirin and extended-release dipyridamole was more effective than aspirin monotherapy, and probably more effective than anticoagulants, for the prevention of cerebrovascular events after a stroke or transient ischemic attack. When viewed in light of results of earlier trials, these findings confirmed that combination aspirin plus extended-release dipyridamole therapy improved outcomes in these patients and is a recommended option for poststroke patient treatment.
Faurholt-Jepsen, M; Frost, M; Ritz, C; Christensen, E M; Jacoby, A S; Mikkelsen, R L; Knorr, U; Bardram, J E; Vinberg, M; Kessing, L V
The number of studies on electronic self-monitoring in affective disorder and other psychiatric disorders is increasing and indicates high patient acceptance and adherence. Nevertheless, the effect of electronic self-monitoring in patients with bipolar disorder has never been investigated in a randomized controlled trial (RCT). The objective of this trial was to investigate in a RCT whether the use of daily electronic self-monitoring using smartphones reduces depressive and manic symptoms in patients with bipolar disorder. A total of 78 patients with bipolar disorder according to ICD-10 criteria, aged 18-60 years, and with 17-item Hamilton Depression Rating Scale (HAMD-17) and Young Mania Rating Scale (YMRS) scores ≤17 were randomized to the use of a smartphone for daily self-monitoring including a clinical feedback loop (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for 6 months. The primary outcomes were differences in depressive and manic symptoms measured using HAMD-17 and YMRS, respectively, between the intervention and control groups. Intention-to-treat analyses using linear mixed models showed no significant effects of daily self-monitoring using smartphones on depressive as well as manic symptoms. There was a tendency towards more sustained depressive symptoms in the intervention group (B = 2.02, 95% confidence interval -0.13 to 4.17, p = 0.066). Sub-group analysis among patients without mixed symptoms and patients with presence of depressive and manic symptoms showed significantly more depressive symptoms and fewer manic symptoms during the trial period in the intervention group. These results highlight that electronic self-monitoring, although intuitive and appealing, needs critical consideration and further clarification before it is implemented as a clinical tool.
Ali, Mohammad; Liu, Xuanyao; Pillai, Esakimuthu Nisha; Chen, Peng; Khor, Chiea-Chuen; Ong, Rick Twee-Hee; Teo, Yik-Ying
India is home to many ethnically and linguistically diverse populations. It is hypothesized that history of invasions by people from Persia and Central Asia, who are referred as Aryans in Hindu Holy Scriptures, had a defining role in shaping the Indian population canvas. A shift in spoken languages from Dravidian languages to Indo-European languages around 1500 B.C. is central to the Aryan Invasion Theory. Here we investigate the genetic differences between two sub-populations of India consisting of: (1) The Indo-European language speaking Gujarati Indians with genome-wide data from the International HapMap Project; and (2) the Dravidian language speaking Tamil Indians with genome-wide data from the Singapore Genome Variation Project. We implemented three population genetics measures to identify genomic regions that are significantly differentiated between the two Indian populations originating from the north and south of India. These measures singled out genomic regions with: (i) SNPs exhibiting significant variation in allele frequencies in the two Indian populations; and (ii) differential signals of positive natural selection as quantified by the integrated haplotype score (iHS) and cross-population extended haplotype homozygosity (XP-EHH). One of the regions that emerged spans the SLC24A5 gene that has been functionally shown to affect skin pigmentation, with a higher degree of genetic sharing between Gujarati Indians and Europeans. Our finding points to a gene-flow from Europe to north India that provides an explanation for the lighter skin tones present in North Indians in comparison to South Indians.
Exley, Karen; Cano, Noemi; Aerts, Dominique; Biot, Pierre; Casteleyn, Ludwine; Kolossa-Gehring, Marike; Schwedler, Gerda; Castaño, Argelia; Angerer, Jürgen; Koch, Holger M; Esteban, Marta; Schoeters, Greet; Den Hond, Elly; Horvat, Milena; Bloemen, Louis; Knudsen, Lisbeth E; Joas, Reinhard; Joas, Anke; Dewolf, Marie-Christine; Van de Mieroop, Els; Katsonouri, Andromachi; Hadjipanayis, Adamos; Cerna, Milena; Krskova, Andrea; Becker, Kerstin; Fiddicke, Ulrike; Seiwert, Margarete; Mørck, Thit A; Rudnai, Peter; Kozepesy, Szilvia; Cullen, Elizabeth; Kellegher, Anne; Gutleb, Arno C; Fischer, Marc E; Ligocka, Danuta; Kamińska, Joanna; Namorado, Sónia; Reis, M Fátima; Lupsa, Ioana-Rodica; Gurzau, Anca E; Halzlova, Katarina; Jajcaj, Michal; Mazej, Darja; Tratnik, Janja Snoj; Huetos, Olga; López, Ana; Berglund, Marika; Larsson, Kristin; Sepai, Ovnair
A communication strategy was developed by The Consortium to Perform Human Biomonitoring on a European Scale (COPHES), as part of its objectives to develop a framework and protocols to enable the collection of comparable human biomonitoring data throughout Europe. The framework and protocols were tested in the pilot study DEMOCOPHES (Demonstration of a study to Coordinate and Perform Human biomonitoring on a European Scale). The aims of the communication strategy were to raise awareness of human biomonitoring, encourage participation in the study and to communicate the study results and their public health significance. It identified the audiences and key messages, documented the procedure for dissemination of results and was updated as the project progressed. A communication plan listed the tools and materials such as press releases, flyers, recruitment letters and information leaflets required for each audience with a time frame for releasing them. Public insight research was used to evaluate the recruitment material, and the feedback was used to improve the documents. Dissemination of results was coordinated in a step by step approach by the participating countries within DEMOCOPHES, taking into account specific national messages according to the needs of each country. Participants received individual results, unless they refused to be informed, along with guidance on what the results meant. The aggregate results and policy recommendations were then communicated to the general public and stakeholders, followed by dissemination at European level. Several lessons were learnt that may assist other future human biomonitoring studies. Recruitment took longer than anticipated and so social scientists, to help with community engagement, should be part of the research team from the start. As a European study, involving multiple countries, additional considerations were needed for the numerous organisations, different languages, cultures, policies and priorities
Sioen, Isabelle; van Lieshout, Lilou; Eilander, Ans; Fleith, Mathilde; Lohner, Szimonetta; Szommer, Alíz; Petisca, Catarina; Eussen, Simone; Forsyth, Stewart; Calder, Philip C; Campoy, Cristina; Mensink, Ronald P
Earlier reviews indicated that in many countries adults, children and adolescents consume on an average less polyunsaturated fatty acids (PUFAs) than recommended by the Food and Agriculture Organisation/World Health Organisation. The intake of total and individual n-3 and n-6 PUFAs in European infants, children, adolescents, elderly and pregnant/lactating women was evaluated systematically. The evaluations were done against recommendations of the European Food Safety Authority. Key Messages: Fifty-three studies from 17 different European countries reported an intake of total n-3 and n-6 PUFAs and/or individual n-3 or n-6 PUFAs in at least one of the specific population groups: 10 in pregnant women, 4 in lactating women, 3 in infants 6-12 months, 6 in children 1-3 years, 11 in children 4-9 years, 8 in adolescents 10-18 years and 11 in elderly >65 years. Mean linoleic acid intake was within the recommendation (4 energy percentage [E%]) in 52% of the countries, with inadequate intakes more likely in lactating women, adolescents and elderly. Mean α-linolenic acid intake was within the recommendation (0.5 E%) in 77% of the countries. In 26% of the countries, mean eicosapentaenoic acid and/or docosahexaenoic acid intake was as recommended. These results indicate that intake of n-3 and n-6 PUFAs may be suboptimal in specific population groups in Europe. © 2017 S. Karger AG, Basel.
Sioen, Isabelle; van Lieshout, Lilou; Eilander, Ans; Fleith, Mathilde; Lohner, Szimonetta; Szommer, Alíz; Petisca, Catarina; Eussen, Simone; Forsyth, Stewart; Calder, Philip C.; Campoy, Cristina; Mensink, Ronald P.
Background Earlier reviews indicated that in many countries adults, children and adolescents consume on an average less polyunsaturated fatty acids (PUFAs) than recommended by the Food and Agriculture Organisation/World Health Organisation. Summary The intake of total and individual n-3 and n-6 PUFAs in European infants, children, adolescents, elderly and pregnant/lactating women was evaluated systematically. Results The evaluations were done against recommendations of the European Food Safety Authority. Key Messages Fifty-three studies from 17 different European countries reported an intake of total n-3 and n-6 PUFAs and/or individual n-3 or n-6 PUFAs in at least one of the specific population groups: 10 in pregnant women, 4 in lactating women, 3 in infants 6–12 months, 6 in children 1–3 years, 11 in children 4–9 years, 8 in adolescents 10–18 years and 11 in elderly >65 years. Mean linoleic acid intake was within the recommendation (4 energy percentage [E%]) in 52% of the countries, with inadequate intakes more likely in lactating women, adolescents and elderly. Mean α-linolenic acid intake was within the recommendation (0.5 E%) in 77% of the countries. In 26% of the countries, mean eicosapentaenoic acid and/or docosahexaenoic acid intake was as recommended. These results indicate that intake of n-3 and n-6 PUFAs may be suboptimal in specific population groups in Europe. PMID:28190013
Rimm, David L; Nielsen, Torsten O; Jewell, Scott D; Rohrer, Daniel C; Broadwater, Gloria; Waldman, Frederic; Mitchell, Kisha A; Singh, Baljit; Tsongalis, Gregory J; Frankel, Wendy L; Magliocco, Anthony M; Lara, Jonathan F; Hsi, Eric D; Bleiweiss, Ira J; Badve, Sunil S; Chen, Beiyun; Ravdin, Peter M; Schilsky, Richard L; Thor, Ann; Berry, Donald A
Practice-changing evidence requires confirmation, preferably in multi-institutional clinical trials. The collection of tissue within such trials has enabled biomarker studies and evaluation of companion diagnostic tests. Tissue microarrays (TMAs) have become a standard approach in many cooperative oncology groups. A principal goal is to maximize the number of assays with this precious tissue. However, production strategies for these arrays have not been standardized, possibly decreasing the value of the study. In this article, members of the Cancer and Leukemia Group B Pathology Committee relay our experiences as array facility directors and propose guidelines regarding the production of high-quality TMAs for cooperative group studies. We also discuss statistical issues arising from having a proportion of patients available for TMAs and the possibility that patients with TMAs fail to represent the greater study population.
Baljé, Astrid; Greeven, Anja; van Giezen, Anne; Korrelboom, Kees; Arntz, Arnoud; Spinhoven, Philip
Social anxiety disorder (SAD) with comorbid avoidant personality disorder (APD) has a high prevalence and is associated with serious psychosocial problems and high societal costs. When patients suffer from both SAD and APD, the Dutch multidisciplinary guidelines for personality disorders advise offering prolonged cognitive behavioral therapy (CBT). Recently there is increasing evidence for the effectiveness of schema therapy (ST) for personality disorders such as borderline personality disorder and cluster C personality disorders. Since ST addresses underlying personality characteristics and maladaptive coping strategies developed in childhood, this treatment might be particularly effective for patients with SAD and comorbid APD. To our knowledge, there are no studies comparing CBT with ST in this particular group of patients. This superiority trial aims at comparing the effectiveness of these treatments. As an additional goal, predictors and underlying mechanisms of change will be explored. The design of the study is a multicentre two-group randomized controlled trial (RCT) in which the treatment effect of group cognitive behavioral therapy (GCBT) will be compared to that of group schema therapy (GST) in a semi-open group format. A total of 128 patients aged 18-65 years old will be enrolled. Patients will receive 30 sessions of GCBT or GST during a period of approximately 9 months. Primary outcome measures are the Liebowitz Social Anxiety Scale Self-Report (LSAS-SR) for social anxiety disorder and the newly developed Avoidant Personality Disorder Severity Index (AVPDSI) for avoidant personality disorder. Secondary outcome measures are the MINI section SAD, the SCID-II section APD, the Schema Mode Inventory (SMI-2), the Inventory of Depressive Symptomatology Self-Report (IDS-SR), the World Health Organization Quality of Life-BREF (WHOQOL-BREF), the Difficulties in Emotion Regulation Scale (DERS), the Rosenberg Self-Esteem Scale (RSES) and the Acceptance and Action
Murphy, Glynis H.; Shepstone, Lee; Wilson, Edward C.F.; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra; Rose, Alice; Mullineaux, Louise
Background There is a growing interest in using cognitive–behavioural therapy (CBT) with people who have Asperger syndrome and comorbid mental health problems. Aims To examine whether modified group CBT for clinically significant anxiety in an Asperger syndrome population is feasible and likely to be efficacious. Method Using a randomised assessor-blind trial, 52 individuals with Asperger syndrome were randomised into a treatment arm or a waiting-list control arm. After 24 weeks, those in the waiting-list control arm received treatment, while those initially randomised to treatment were followed up for 24 weeks. Results The conversion rate for this trial was high (1.6:1), while attrition was 13%. After 24 weeks, there was no significant difference between those randomised to the treatment arm compared with those randomised to the waiting-list control arm on the primary outcome measure, the Hamilton Rating Scale for Anxiety. Conclusions Trials of psychological therapies with this population are feasible. Larger definitive trials are now needed. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) licence. PMID:27703772
Langdon, Peter E; Murphy, Glynis H; Shepstone, Lee; Wilson, Edward C F; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra; Rose, Alice; Mullineaux, Louise
There is a growing interest in using cognitive-behavioural therapy (CBT) with people who have Asperger syndrome and comorbid mental health problems. To examine whether modified group CBT for clinically significant anxiety in an Asperger syndrome population is feasible and likely to be efficacious. Using a randomised assessor-blind trial, 52 individuals with Asperger syndrome were randomised into a treatment arm or a waiting-list control arm. After 24 weeks, those in the waiting-list control arm received treatment, while those initially randomised to treatment were followed up for 24 weeks. The conversion rate for this trial was high (1.6:1), while attrition was 13%. After 24 weeks, there was no significant difference between those randomised to the treatment arm compared with those randomised to the waiting-list control arm on the primary outcome measure, the Hamilton Rating Scale for Anxiety. Trials of psychological therapies with this population are feasible. Larger definitive trials are now needed. None. © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) licence.
Barrington, Sally F; Qian, Wendi; Somer, Edward J
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.......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....
Zannad, Faiez; Garcia, Angeles Alonso; Anker, Stefan D.; Armstrong, Paul W.; Calvo, Gonzalo; Cleland, John G. F.; Cohn, Jay N.; Dickstein, Kenneth; Domanski, Michael J.; Ekman, Inger; Filippatos, Gerasimos S.; Gheorghiade, Mihai; Hernandez, Adrian F.; Jaarsma, Tiny; Koglin, Joerg; Konstam, Marvin; Kupfer, Stuart; Maggioni, Aldo P.; Mebazaa, Alexandre; Metra, Marco; Nowack, Christina; Pieske, Burkert; Pina, Ileana L.; Pocock, Stuart J.; Ponikowski, Piotr; Rosano, Giuseppe; Ruilope, Luis M.; Ruschitzka, Frank; Severin, Thomas; Solomon, Scott; Stein, Kenneth; Stockbridge, Norman L.; Stough, Wendy Gattis; Swedberg, Karl; Tavazzi, Luigi; Voors, Adriaan A.; Wasserman, ScottM.; Woehrle, Holger; Zalewski, Andrew; McMurray, John J. V.
Endpoint selection is a critically important step in clinical trial design. It poses major challenges for investigators, regulators, and study sponsors, and it also has important clinical and practical implications for physicians and patients. Clinical outcomes of interest in heart failure trials
Staudacher, Heidi M; Irving, Peter M; Lomer, Miranda C E; Whelan, Kevin
High-quality placebo-controlled evidence for food, nutrient or dietary advice interventions is vital for verifying the role of diet in optimising health or for the management of disease. This could be argued to be especially important where the benefits of dietary intervention are coupled with potential risks such as compromising nutrient intake, particularly in the case of exclusion diets. The objective of the present paper is to explore the challenges associated with clinical trials in dietary research, review the types of controls used and present the advantages and disadvantages of each, including issues regarding placebos and blinding. Placebo-controlled trials in nutrient interventions are relatively straightforward, as in general placebos can be easily produced. However, the challenges associated with conducting placebo-controlled food interventions and dietary advice interventions are protean, and this has led to a paucity of placebo-controlled food and dietary advice trials compared with drug trials. This review appraises the types of controls used in dietary intervention trials and provides recommendations and nine essential criteria for the design and development of sham diets for use in studies evaluating the effect of dietary advice, along with practical guidance regarding their evaluation. The rationale for these criteria predominantly relate to avoiding altering the outcome of interest in those delivered the sham intervention in these types of studies, while not compromising blinding.
Boon, Polly E; van Donkersgoed, Gerda; Christodoulou, Despo; Crépet, Amélie; D'Addezio, Laura; Desvignes, Virginie; Ericsson, Bengt-Göran; Galimberti, Francesco; Ioannou-Kakouri, Eleni; Jensen, Bodil Hamborg; Rehurkova, Irena; Rety, Josselin; Ruprich, Jiri; Sand, Salomon; Stephenson, Claire; Strömberg, Anita; Turrini, Aida; van der Voet, Hilko; Ziegler, Popi; Hamey, Paul; van Klaveren, Jacob D
The practicality was examined of performing a cumulative dietary exposure assessment according to the requirements of the EFSA guidance on probabilistic modelling. For this the acute and chronic cumulative exposure to triazole pesticides was estimated using national food consumption and monitoring data of eight European countries. Both the acute and chronic cumulative dietary exposures were calculated according to two model runs (optimistic and pessimistic) as recommended in the EFSA guidance. The exposures obtained with these model runs differed substantially for all countries, with the highest exposures obtained with the pessimistic model run. In this model run, animal commodities including cattle milk and different meat types, entered in the exposure calculations at the level of the maximum residue limit (MRL), contributed most to the exposure. We conclude that application of the optimistic model run on a routine basis for cumulative assessments is feasible. The pessimistic model run is laborious and the exposure results could be too far from reality. More experience with this approach is needed to stimulate the discussion of the feasibility of all the requirements, especially the inclusion of MRLs of animal commodities which seem to result in unrealistic conclusions regarding their contribution to the dietary exposure. Copyright © 2014 Elsevier Ltd. All rights reserved.
Creamer, J; Attridge, M; Ramsden, M; Cannings-John, R; Hawthorne, K
To give an updated perspective of interventions from additional data collected since our first review, conducted in 2008. This updated Cochrane Review incorporates new information from recent randomized controlled trials on culturally appropriate diabetes health education interventions. An electronic literature search of six databases was repeated, with databases of ongoing trials checked and three journals hand-searched. Meta-analysis was carried out for sufficiently homogeneous outcomes, and common themes among trials were highlighted. A total of 22 new trials were added to the original 11. Meta-analysis of 28 trials containing suitable data showed significant improvements in glycaemic control (HbA1c ) and diabetes knowledge over a period of 24 months, after the delivery of culturally appropriate education to participants, compared with those receiving 'conventional' care. There were no consistent benefits over the control group in other selected outcome measures, and lack of data continued to make analysis of several outcome measures difficult. Research activity in this field has increased considerably over the past 6 years, with culturally appropriate diabetes education showing consistent benefits over conventional care in terms of glycaemic control and diabetes knowledge, sustained in the short- to mid-term. Further research is needed to determine the clinical significance of these improvements and their cost-effectiveness. © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.
das Nair, Roshan; Kontou, Eirini; Smale, Kathryn; Barker, Alex; Lincoln, Nadina B
To modify a published group intervention for adjustment to multiple sclerosis (MS) to suit an individual format, and to assess the feasibility of a randomised controlled trial (RCT) to compare individual and group intervention for people with multiple sclerosis and low mood. Feasibility randomised controlled trial. Participants were recruited through healthcare professionals at a hospital-based multiple sclerosis service and the MS Society. People with multiple sclerosis. Adjustment to multiple sclerosis in individual or group delivery format. Participants completed mood and quality of life assessments at baseline and at four-month follow-up. Measures of feasibility included: recruitment rate, acceptability of randomisation and the intervention (content and format), and whether the intervention could be adapted for individual delivery. Participants were screened for inclusion using the General Health Questionnaire-12 and Hospital Anxiety and Depression Scale, and were randomly allocated to receive either individual or group intervention, with the same content. Twenty-one participants were recruited (mean age 48.5 years, SD 10.5) and were randomly allocated to individual (n=11) or group (n=10) intervention. Of those offered individual treatment, nine (82%) completed all six sessions. Of those allocated to group intervention, two (20%) attended all six sessions and three (30%) attended five sessions. There were no statistically significant differences between the groups on the outcome measures of mood and quality of life. The intervention could be provided on an individual basis and the trial design was feasible. There were lower attendance rates at group sessions compared to individual sessions. © The Author(s) 2015.
Full Text Available It is valuable to extend genotyping studies of Helicobacter pylori to strains from indigenous communities across the world to better define adaption, evolution, and associated diseases. We aimed to genetically characterize both human individuals and their infecting H. pylori from indigenous communities of Mexico, and to compare them with those from other human groups. We studied individuals from three indigenous groups, Tarahumaras from the North, Huichols from the West and Nahuas from the center of Mexico. Volunteers were sampled at their community site, DNA was isolated from white blood cells and mtDNA, Y-chromosome, and STR alleles were studied. H. pylori was cultured from gastric juice, and DNA extracted for genotyping of virulence and housekeeping genes. We found Amerindian mtDNA haplogroups (A, B, C, and D, Y-chromosome DYS19T, and Amerindian STRs alleles frequent in the three groups, confirming Amerindian ancestry in these Mexican groups. Concerning H.pylori cagA phylogenetic analyses, although most isolates were of the Western type, a new Amerindian cluster neither Western nor Asian, was formed by some indigenous Mexican, Colombian, Peruvian and Venezuelan isolates. Similarly, vacA phylogenetic analyses showed the existence of a novel Amerindian type in isolates from Alaska, Mexico and Colombia. With hspA strains from Mexico and other American groups clustered within the three major groups, Asian, African or European. Genotyping of housekeeping genes confirmed that Mexican strains formed a novel Asian-related Amerindian group together with strains from remote Amazon Aborigines. This study shows that Mexican indigenous people with Amerindian markers are colonized with H. pylori showing admixture of Asian, European and African strains in genes known to interact with the gastric mucosa. We present evidence of novel Amerindian cagA and vacA alleles in indigenous groups of North and South America.
Camorlinga-Ponce, Margarita; Perez-Perez, Guillermo; Gonzalez-Valencia, Gerardo; Mendoza, Irma; Peñaloza-Espinosa, Rosenda; Ramos, Irma; Kersulyte, Dangeruta; Reyes-Leon, Adriana; Romo, Carolina; Granados, Julio; Muñoz, Leopoldo; Berg, Douglas E.; Torres, Javier
It is valuable to extend genotyping studies of Helicobacter pylori to strains from indigenous communities across the world to better define adaption, evolution, and associated diseases. We aimed to genetically characterize both human individuals and their infecting H. pylori from indigenous communities of Mexico, and to compare them with those from other human groups. We studied individuals from three indigenous groups, Tarahumaras from the North, Huichols from the West and Nahuas from the center of Mexico. Volunteers were sampled at their community site, DNA was isolated from white blood cells and mtDNA, Y-chromosome, and STR alleles were studied. H. pylori was cultured from gastric juice, and DNA extracted for genotyping of virulence and housekeeping genes. We found Amerindian mtDNA haplogroups (A, B, C, and D), Y-chromosome DYS19T, and Amerindian STRs alleles frequent in the three groups, confirming Amerindian ancestry in these Mexican groups. Concerning H.pylori cagA phylogenetic analyses, although most isolates were of the Western type, a new Amerindian cluster neither Western nor Asian, was formed by some indigenous Mexican, Colombian, Peruvian and Venezuelan isolates. Similarly, vacA phylogenetic analyses showed the existence of a novel Amerindian type in isolates from Alaska, Mexico and Colombia. With hspA strains from Mexico and other American groups clustered within the three major groups, Asian, African or European. Genotyping of housekeeping genes confirmed that Mexican strains formed a novel Asian-related Amerindian group together with strains from remote Amazon Aborigines. This study shows that Mexican indigenous people with Amerindian markers are colonized with H. pylori showing admixture of Asian, European and African strains in genes known to interact with the gastric mucosa. We present evidence of novel Amerindian cagA and vacA alleles in indigenous groups of North and South America. PMID:22073291
Camorlinga-Ponce, Margarita; Perez-Perez, Guillermo; Gonzalez-Valencia, Gerardo; Mendoza, Irma; Peñaloza-Espinosa, Rosenda; Ramos, Irma; Kersulyte, Dangeruta; Reyes-Leon, Adriana; Romo, Carolina; Granados, Julio; Muñoz, Leopoldo; Berg, Douglas E; Torres, Javier
It is valuable to extend genotyping studies of Helicobacter pylori to strains from indigenous communities across the world to better define adaption, evolution, and associated diseases. We aimed to genetically characterize both human individuals and their infecting H. pylori from indigenous communities of Mexico, and to compare them with those from other human groups. We studied individuals from three indigenous groups, Tarahumaras from the North, Huichols from the West and Nahuas from the center of Mexico. Volunteers were sampled at their community site, DNA was isolated from white blood cells and mtDNA, Y-chromosome, and STR alleles were studied. H. pylori was cultured from gastric juice, and DNA extracted for genotyping of virulence and housekeeping genes. We found Amerindian mtDNA haplogroups (A, B, C, and D), Y-chromosome DYS19T, and Amerindian STRs alleles frequent in the three groups, confirming Amerindian ancestry in these Mexican groups. Concerning H.pylori cagA phylogenetic analyses, although most isolates were of the Western type, a new Amerindian cluster neither Western nor Asian, was formed by some indigenous Mexican, Colombian, Peruvian and Venezuelan isolates. Similarly, vacA phylogenetic analyses showed the existence of a novel Amerindian type in isolates from Alaska, Mexico and Colombia. With hspA strains from Mexico and other American groups clustered within the three major groups, Asian, African or European. Genotyping of housekeeping genes confirmed that Mexican strains formed a novel Asian-related Amerindian group together with strains from remote Amazon Aborigines. This study shows that Mexican indigenous people with Amerindian markers are colonized with H. pylori showing admixture of Asian, European and African strains in genes known to interact with the gastric mucosa. We present evidence of novel Amerindian cagA and vacA alleles in indigenous groups of North and South America.
de Groot, Femke M; Voogt-Bode, Annieke; Passchier, Jan; Berger, Marjolein Y; Koes, Bart W; Verhagen, Arianne P
The purpose of this study is to describe the effects in the placebo and "no treatment" arms in trials with headache patients. This is a secondary analysis of randomized controlled trials from 8 systematic reviews and selected trials with a "no treatment" or placebo control group. The different types of "no treatment" and placebo interventions were assessed and classified into 6 subgroups. The analyses were carried out according to type of outcome variable. In total, 119 studies were included (7119 participants). The mean recovery rate in all control groups was 35.7%. Significantly more participants recovered in control groups of pharmacological studies than in nonpharmacological studies: 38.5% vs 15.0%, respectively. Adults were more likely to recover in nonpharmacological studies and children in pharmacological studies. The mean recovery rate in the control groups was 36%. The recovery rate varied substantially between type of intervention and patients. Copyright © 2011 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.
Sandsjö, L; Larsman, P; Vollenbroek-Hutten, M M R
There is a lack of consistent and comprehensive questionnaire forms for the studies of factors associated with work-related musculoskeletal disorders at the European level. One of the results of the EU-funded project, neuromuscular assessment in the elderly worker (NEW), is a set of questionnaires...... for the screening of musculoskeletal status and the studies of factors that are believed to affect musculoskeletal health. The questionnaires have been used among elderly women (45+) in different occupations and organisations in Denmark, The Netherlands, Sweden and Switzerland. The aim of this short communication...... is to present the questionnaires used in the NEW study and to evaluate the appropriateness of pooling data gathered in each participating country into a common database. It is concluded that although differences exist among the study samples, these are not of such a magnitude or pattern that data from the four...
Ruzicka, T.; Bieber, T.; Schöpf, E.; Rubins, A.; Dobozy, A.; Bos, J. D.; Jablonska, S.; Ahmed, I.; Thestrup-Pedersen, K.; Daniel, F.; Finzi, A.; Reitamo, S.
Tacrolimus (FK 506) is an effective immunosuppressant drug for the prevention of rejection after organ transplantation, and preliminary studies suggest that topical application of tacrolimus is effective in the treatment of atopic dermatitis. We conducted a randomized, doubleblind, multicenter study
Kenyon, S L; Taylor, D J; Tarnow-Mordi, W
Preterm birth after spontaneous preterm labour is associated with death, neonatal disease, and long-term disability. Previous small trials of antibiotics for spontaneous preterm labour have reported inconclusive results. We did a randomised multicentre trial to resolve this issue. 6295 women in spontaneous preterm labour with intact membranes and without evidence of clinical infection were randomly assigned 250 mg erythromycin (n=1611), 325 mg co-amoxiclav (250 mg amoxicillin and 125 mg clavulanic acid; n=1550), both (n=1565), or placebo (n=1569) four times daily for 10 days or until delivery, whichever occurred earlier. The primary outcome measure was a composite of neonatal death, chronic lung disease, or major cerebral abnormality on ultrasonography before discharge from hospital. Analysis was by intention to treat. None of the trial antibiotics was associated with a lower rate of the composite primary outcome than placebo (erythromycin 90 [5.6%], co-amoxiclav 76 [5.0%], both antibiotics 91 [5.9%], vs placebo 78 [5.0%]). However, antibiotic prescription was associated with a lower occurrence of maternal infection. This trial provides evidence that antibiotics should not be routinely prescribed for women in spontaneous preterm labour without evidence of clinical infection.
Full Text Available This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS.A mixed-methods randomized controlled trial (intervention (INT vs. waitlist (WL was conducted with patients suffering from FMS. Data were collected at baseline (T0, at the end of the intervention (T1, and 3 months later (T2. The primary outcome was change in pain intensity (0-10. Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC, and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients.The intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively than in the WL Group (8%, 12%, 20%. The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%. The proportion of patients who reported ≥ 50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12% and 3 months post-intervention (33% vs 4%. Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures.The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients' experience.International Standard Randomized Controlled Trial Number
Jager, C.; Freund, T.; Steinhauser, J.; Aakhus, E.; Flottorp, S.; Godycki-Cwirko, M.; Lieshout, J. van; Krause, J.; Szecsenyi, J.; Wensing, M.
BACKGROUND: In the 'Tailored Implementation for Chronic Diseases (TICD)' project, five tailored implementation programs to improve healthcare delivery in different chronic conditions have been developed. These programs will be evaluated in distinct cluster-randomized controlled trials. This protocol
Dickson, John Caddell; Tossici-Bolt, Livia; Sera, Terez; de Nijs, Robin; Booij, Jan; Bagnara, Maria Claudia; Seese, Anita; Koulibaly, Pierre Malick; Akdemir, Umit Ozgur; Jonsson, Cathrine; Koole, Michel; Raith, Maria; Lonsdale, Markus Nowak; George, Jean; Zito, Felicia; Tatsch, Klaus
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 framework for performing high-quality multi-centre trials with single photon emission computed tomography (SPECT), using a pan-European initiative to acquire a normal control dopamine transporter brain scan database as an example. A framework to produce high-quality and consistent SPECT imaging data was based on three key areas: quality assurance, the imaging protocol and system characterisation. Quality assurance was important to ensure that the quality of the equipment and local techniques was good and consistently high; system characterisation helped understand and where possible match the performance of the systems involved, whereas the imaging protocol was designed to allow a degree of flexibility to best match the characteristics of each imaging device. A total of 24 cameras on 15 sites from 8 different manufacturers were evaluated for inclusion in our multi-centre initiative. All results matched the required level of specification and each had their performance characterised. Differences in performance were found between different system types and cameras of the same type. Imaging protocols for each site were modified to match their individual characteristics to produce comparable high-quality SPECT images. A framework has been designed to produce high-quality data for multi-centre SPECT studies. This framework has been successfully applied to a pan-European initiative to acquire a healthy control dopamine transporter image database.
Sobell, Linda Carter; Sobell, Mark B; Agrawal, Sangeeta
Although group therapy is widely used for individuals with substance use disorders (SUDs), randomized clinical trials (RCTs) comparing the same treatment in a group versus individual format are rare. This paper presents the results of a RCT comparing guided self-change (GSC) treatment, a cognitive-behavioral motivational intervention, conducted in a group versus individual format with 212 alcohol abusers and 52 drug abusers who voluntarily sought outpatient treatment. Treatment outcomes demonstrated significant and large reductions in clients' alcohol and drug use during treatment and at the 12-month follow-up, with no significant differences between the group and individual therapy conditions. A therapist time ratio analysis found that it took 41.4% less therapist time to treat clients using the group versus the individual format. Participants' end-of-treatment group cohesion scores characterized the groups as having high engagement, low levels of interpersonal conflict, and low avoidance of group work, all desirable group characteristics. These findings suggest that the GSC treatment model was effectively integrated into a brief group treatment format. Health care cost containment compels further evaluations of the efficacy of group treatments for SUDs. Copyright 2009 APA
McQuaid, Fiona; Pask, Sophie; Locock, Louise; Davis, Elizabeth; Stevens, Zoe; Plumb, Jane; Snape, Matthew D
Antenatal vaccination has become a part of routine care during pregnancy in the UK and worldwide, leading to improvements in health for both pregnant women and their infants. However, uptake remains sub-optimal. Other antenatal vaccines targeting major neonatal pathogens, such as Group B streptococcus (GBS), the commonest cause of sepsis and meningitis in the neonatal period, are undergoing clinical trials but more information is needed on how to improve acceptance of such vaccines. Qualitative study using focus groups and interviews; involving 14 pregnant women, 8 mothers with experience of GBS, and 28 maternity healthcare professionals. Questions were asked regarding antenatal vaccines, knowledge of GBS, attitudes to a potential future GBS vaccine and participation in antenatal vaccine trials. All participants were very cautious about vaccination during pregnancy, with harm to the baby being a major concern. Despite this, the pregnant women and parents with experience of GBS were open to the idea of an antenatal GBS vaccine and participating in research, while the maternity professionals were less positive. Major barriers identified included lack of knowledge about GBS and the reluctance of maternity professionals to be involved. In order for a future GBS vaccine to be acceptable to both pregnant women and the healthcare professionals advising them, a major awareness campaign would be required with significant focus on convincing and training maternity professionals. Copyright © 2016 Elsevier Ltd. All rights reserved.
EURObservational Research Programme: a worldwide registry on peripartum cardiomyopathy (PPCM) in conjunction with the Heart Failure Association of the European Society of Cardiology Working Group on PPCM.
Sliwa, Karen; Hilfiker-Kleiner, Denise; Mebazaa, Alexandre; Petrie, Mark C; Maggioni, Aldo P; Regitz-Zagrosek, Vera; Schaufelberger, Maria; Tavazzi, Luigi; van Veldhuisen, Dirk J; Roos-Hesslink, Jolien W; Shah, Ajay J; Seferovic, Petar M; Elkayam, Uri; van Spaendonck-Zwarts, Karin; Bachelier-Walenta, Katrin; Mouquet, Frederic; Kraigher-Krainer, Elisabeth; Hall, Roger; Ponikowski, Piotr; McMurray, John J V; Pieske, Burkert
The EURObservational Research Programme is a rolling programme of cardiovascular registries and surveys of the European Society of Cardiology (ESC). These registries will provide information on the nature of cardiovascular disease and its management. This manuscript provides an update on new literature on peripartum cardiomyopathy (PPCM), published since the 2010 Position Statement from the Heart Failure Association of the European Society of Cardiology Working Group on PPCM, and describes a new registry on this under-recognized condition. Peripartum cardiomyopathy is an idiopathic cardiomyopathy presenting with heart failure secondary to left ventricular systolic dysfunction towards the end of the pregnancy, or in the months following delivery, where no other cause for heart failure is found. The PPCM Registry aims to describe disease presentation, comorbidities, diagnostic and therapeutic management of patients with PPCM, as well as information on their offspring. Centres not only from ESC and ESC-affiliated countries, but from around the world, are encouraged to participate. A prospective registry on patients presenting with PPCM. At the time of writing, approximately 100 patients have been enrolled from 20 countries. All data entry is online via secure passwords and is supported by well-trained information technology personnel. The EURObservational Research Programme will allow a comparison of women from around the world, from different ethnic backgrounds, presenting with PPCM and will report on their 6 month and 12 month outcomes. The study aims to include 1000 patients and follow them for 1 year. New centres volunteering to participate in the study will be welcomed. © 2014 The Authors. European Journal of Heart Failure © 2014 European Society of Cardiology.
Atherton, Pamela J; Burger, Kelli N; Pederson, Levi D; Kaggal, Suneetha; Sloan, Jeff A
The use of patient-reported outcomes in clinical trials is a focal point for research and policy. Non-compliance with planned questionnaires and missing data can threaten both internal validity and generalizability. This retrospective analysis was conducted to determine the extent of, and characteristics associated with, missing patient-reported outcomes. Study characteristics, patient characteristics and adverse events, and reasons for non-compliance were compiled from 14 closed Alliance for Clinical Trials in Oncology, Mayo Clinic Cancer Center, or Mayo Clinic Cancer Research Consortium clinical trials. Compliance rates were calculated for each patient using the number of booklets completed while the patient was on trial divided by the number of booklets the patient was expected to complete. Frequency counts and summary statistics were compiled. Logistic regression techniques were employed. The 1640 included patients had a median age of 58 years and were mostly White (90.8%) and female (73.8%). Compliance rates per study ranged from 84.7% to 97.2%. The primary endpoint of overall compliance rate was 93.1%. A total of 1267 patients were compliant. Those non-compliant were slightly older (mean = 58.6 vs 57.5, p = 0.03) and had different types of cancers (p compliance according to tumor status (p = 0.66), clinical stage (p = 0.81), baseline quality of life (p = 0.42 for ≥8 vs compliance included patient refusal (N = 136), booklet not administered to patient (N = 199), no clinic visit at the scheduled time for booklet completion (N = 40), and at-home-completed booklet not returned (N = 224). Logistic regression indicates gender (p compliance. Patient-reported outcomes have successfully been implemented into Alliance and Mayo Clinic trials with high rates of patient compliance. Further improvement in compliance can be made with staff commitment and education. Patients are typically non-compliant only when the task at hand is
Atherton, Pamela J; Burger, Kelli N; Pederson, Levi D; Kaggal, Suneetha; Sloan, Jeff A
Background/Aims The use of Patient Reported Outcomes (PROs) in clinical trials is a focal point for research and policy. Non-compliance with planned questionnaires and missing data can threaten both internal validity and generalizability. This retrospective analysis was conducted to determine the extent of, and characteristics associated with, missing PROs. Methods Study characteristics, patient characteristics and adverse events, and reasons for non-compliance were compiled from 14 closed Alliance for Clinical Trials in Oncology, Mayo Clinic Cancer Center, or Mayo Clinic Cancer Research Consortium clinical trials. Compliance rates were calculated for each patient using the number of booklets completed while the patient was on trial divided by the number of booklets the patient was expected to complete. Frequency counts and summary statistics were compiled. Logistic regression techniques were employed. Results The 1640 included patients had a median age of 58 years, were mostly white (90.8%) and female (73.8%). Compliance rates per study ranged from 84.7% to 97.2%. The primary endpoint of overall compliance rate was 93.1%. A total of 1267 patients were compliant. Those non-compliant were slightly older (mean 58.6 vs 57.5, p=0.03) and had different types of cancer (pcompliance according to tumor status (p=0.66), clinical stage (p=0.81), baseline quality of life (p=0.42 for ≥8 vs compliance included patient refusal (N=136), booklet not administered to patient (N=199), no clinic visit at the scheduled time for booklet completion (N=40), and at-home completed booklet not returned (N=224). Logistic regression indicates gender (pcompliance. Conclusions PROs have successfully been implemented into Alliance and Mayo Clinic trials with high rates of patient compliance. Further improvement in compliance can be made with staff commitment and education. Patients are typically noncompliant only when the task at hand is burdensome, unclear or logistically challenging. Existing
Compliance of blood sampling procedures with the CLSI H3-A6 guidelines: An observational study by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PRE)
Simundic, Ana-Maria; Church, Stephen; Cornes, Michael P.; Grankvist, Kjell; Lippi, Giuseppe; Nybo, Mads; Nikolac, Nora; van Dongen-Lases, Edmee; Eker, Pinar; Kovalevskaya, Svjetlana; Kristensen, Gunn B. B.; Sprongl, Ludek; Sumarac, Zorica
Abstract Background: An observational study was conducted in 12 European countries by the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) to assess the level of compliance with the CLSI H3-A6 guidelines. Methods: A structured
Full Text Available The aim of the paper is to examine key trends in the European Union’s trade policy towards the African, Caribbean and Pacific group of states (ACP, as well as to identify main changes in the commodity structure of the European (and Polish agri-food trade. The results showed that for the ACP countries, the European market is perceived as a source of food industry while the EU (including Poland imports from ACP region coffee, tea and cocoa. This confirms a certain specialization of production and trade in ACP countries. Both the European Union and Poland, are net importers of agri- food products from the ACP region.
Full Text Available The goal of the paper was the analysis of Romania’s the agro-food export, import and trade balance by the EU country group and agro-food product group based on the statistical data in the year 2010 in order to identify the commercial relationships with a positive and respectively a negative impact of the trade balance. The EU trade partners were divided into 4 groups: Central Eastern (CE, Western (W, Northern (N and Southern (S EU countries and the agro-food product groups were: Live animals and preparations of animal origin, Vegetal products, Fats and oils of vegetal and animal origin, Food, beverages and tobacco. The data were processed using the share and comparison methods. In 2010, Romania registered a negative agro-food trade balance with a deficit of Euro thousand 903,148.This was due to the unefficient commerce with the CE and W EU countries, which together recorded Euro Thousand 1,400,298 deficit. The balance was positively influenced by the Southern EU trade partners whose contribution accounted for Euro thousand 513,953. Therefore, the agro-food trade has to be intensified with the Southern EU countries and to become more relaxed with the CE and W EU countries, especially regarding imports. Live animals are mainly required in the CE and W EU countries, vegetal products in the W and S EU countries, fats and oils in the CE and S EU countries, and finally, food, beverages and tobacco in the S and the CE EU countries. Agro-food imports have to be substantially diminished as long as Romania’ s agriculture is able to produce for the internal market and export has to be intensified especially with the countries with a positive impact on the trade balance.
Moher David; Altman Douglas G; Schulz Kenneth F
Abstract The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience. To encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on bmj.com and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicin...
Van Kessel, Kim E.; van der Keur, Kirstin A.; Dyrskjøt, Lars
: We prospectively included 1239 patients in follow-up for NMIBC in six European countries. Fresh frozen tumor samples were analyzed for GATA2, TBX2, TBX3 and ZIC4 methylation and FGFR3, TERT, PIK3CA and RAS mutation status. Cox-regression analyses identified markers that were significantly associated......-seven patients (4.6%) progressed to muscle-invasive disease. The limited number of progressors in this large cohort compared to older studies is likely due to improved treatment in the last two decades. Overall, wild type FGFR3 and methylation of GATA2 and TBX3 were significantly associated with progression (HR...... 0.34, 2.53 and 2.64, respectively). The PIR for EAU high risk patients was 4.25. Based on FGFR3 mutation status and methylation of GATA2 this cohort could be reclassified into a good class (PIR=0.86, 26.2% of patients), a moderate class (PIR=4.32, 49.7%) and a poor class (PIR=7.66, 24...
Full Text Available Introduction: People with epilepsy (PWE face physical and mental illness, and social stigma, which affect their self-esteem and quality of life. The purpose of this study was to examine the effects of a support group on the self-esteem of PWE. Methods: A Quasi-experimental study was performed on 120 PWE in the Epilepsy Clinic at Srinagarind Hospital. The experimental group (N=60 attended the support group before receiving regular health care services. The control group (N=60 received only regular healthcare services. Data was collected by using the Rosenberg self-esteem scale scoring before and after the experiment. The score was analyzed by using a paired t-test and an independent t-test. Results: The study showed that before the experiment, the self–esteem score of the control group was significantly higher than the experimental group. After the experiment, the scores of the control group and the experimental group showed a significant statistical difference. The score in the control group was significantly lower than the experimental group, while the score in the experimental group was significantly higher than before the experiment. Conclusion: The support group improves the self-esteem of PWE. Medical personnel should set up a support group for PWE to enhance their self-esteem.
Gimsing, Peter; Hjertner, Oyvind; Lenhoff, Stig; Laane, Edward; Remes, Kari; Steingrimsdottir, Hlif; Abildgaard, Niels; Ahlberg, Lucia; Blimark, Cecilie; Dahl, Inger Marie; Forsberg, Karin; Gedde-Dahl, Tobias; Gregersen, Henrik; Gruber, Astrid; Guldbrandsen, Nina; Haukås, Einar; Carlson, Kristina; Kvam, Ann Kristin; Nahi, Hareth; Lindås, Roald; Andersen, Niels Frost; Turesson, Ingemar; Waage, Anders; Westin, Jan; Gregersen, Henrik; Frost Andersen, Niels; Gimsing, Peter; Toffner-Clausen, Nilsaage; Abildgaard, Niels; Laane, Edward; Silvennoinen, Raija; Remes, Kari; Steingrimsdottir, Hlif; Lindås, Roald; Gedde-Dahl, Tobias; Guldbrandsen, Nina; Kristin Kvam, Ann; Haukås, Einar; Marie Dahl, Inger; Hjertner, Oyvind; Waage, Anders; Blimark, Cecilie; Mellqvist, Ulf-Henrik; Westin, Jan; Ahlberg, Lucia; Lenhoff, Stig; Turesson, Ingemar; Linder, Olle; Gruber, Astrid; Nahi, Hareth; Forsberg, Karin; Carlson, Kristina
The Nordic Myeloma Study Group conducted an open randomized trial to compare bortezomib as consolidation therapy given after high-dose therapy and autologous stem cell transplantation (ASCT) with no consolidation in bortezomib-naive patients with newly diagnosed multiple myeloma. Overall, 370 patients were centrally randomly assigned 3 months after ASCT to receive 20 doses of bortezomib given during 21 weeks or no consolidation. The hypothesis was that consolidation therapy would prolong progression-free survival (PFS). The PFS after randomization was 27 months for the bortezomib group compared with 20 months for the control group (P = .05). Fifty-one of 90 patients in the treatment group compared with 32 of 90 controls improved their response after randomization (P = .007). No difference in overall survival was seen. Fatigue was reported more commonly by the bortezomib-treated patients in self-reported quality-of-life (QOL) questionnaires, whereas no other major differences in QOL were recorded between the groups. Consolidation therapy seemed to be beneficial for patients not achieving at least a very good partial response (VGPR) but not for patients in the ≥ VGPR category at randomization. Consolidation with bortezomib after ASCT in bortezomib-naive patients improves PFS without interfering with QOL. This trial was registered at www.clinicaltrials.gov as #NCT00417911. PMID:23616624
Mutrie, Nanette; Campbell, Anna M; Whyte, Fiona; McConnachie, Alex; Emslie, Carol; Lee, Laura; Kearney, Nora; Walker, Andrew; Ritchie, Diana
To determine functional and psychological benefits of a 12 week supervised group exercise programme during treatment for early stage breast cancer, with six month follow-up. Pragmatic randomised controlled prospective open trial. Three National Health Service oncology clinics in Scotland and community exercise facilities. 203 women entered the study; 177 completed the six month follow-up. Supervised 12 week group exercise programme in addition to usual care, compared with usual care. Functional assessment of cancer therapy (FACT) questionnaire, Beck depression inventory, positive and negative affect scale, body mass index, seven day recall of physical activity, 12 minute walk test, and assessment of shoulder mobility. Mixed effects models with adjustment for baseline values, study site, treatment at baseline, and age gave intervention effect estimates (intervention minus control) at 12 weeks of 129 (95% confidence interval 83 to 176) for metres walked in 12 minutes, 182 (75 to 289) for minutes of moderate intensity activity reported in a week, 2.6 (1.6 to 3.7) for shoulder mobility, 2.5 (1.0 to 3.9) for breast cancer specific subscale of quality of life, and 4.0 (1.8 to 6.3) for positive mood. No significant effect was seen for general quality of life (FACT-G), which was the primary outcome. At the six month follow-up, most of these effects were maintained and an intervention effect for breast cancer specific quality of life emerged. No adverse effects were noted. Supervised group exercise provided functional and psychological benefit after a 12 week intervention and six months later. Clinicians should encourage activity for their patients. Policy makers should consider the inclusion of exercise opportunities in cancer rehabilitation services. Trial registration Current controlled trials ISRCTN12587864 [controlled-trials.com].
Kritaya Sawangchareon; Sineenard Pranboon; Somsak Tiamkao; Kittisak Sawanyawisuth
Introduction: People with epilepsy (PWE) face physical and mental illness, and social stigma, which affect their self-esteem and quality of life. The purpose of this study was to examine the effects of a support group on the self-esteem of PWE. Methods: A Quasi-experimental study was performed on 120 PWE in the Epilepsy Clinic at Srinagarind Hospital. The experimental group (N=60) attended the support group before receiving regular health care services. The control group (N...
Antithrombotic therapy in atrial fibrillation associated with valvular heart disease: a joint consensus document from the European Heart Rhythm Association (EHRA) and European Society of Cardiology Working Group on Thrombosis, endorsed by the ESC Working Group on Valvular Heart Disease, Cardiac Arrhythmia Society of Southern Africa (CASSA), Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), South African Heart (SA Heart) Association and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLEACE).
Lip, Gregory Y H; Collet, Jean Philippe; Caterina, Raffaele de; Fauchier, Laurent; Lane, Deirdre A; Larsen, Torben B; Marin, Francisco; Morais, Joao; Narasimhan, Calambur; Olshansky, Brian; Pierard, Luc; Potpara, Tatjana; Sarrafzadegan, Nizal; Sliwa, Karen; Varela, Gonzalo; Vilahur, Gemma; Weiss, Thomas; Boriani, Giuseppe; Rocca, Bianca
Atrial fibrillation (AF) is a major worldwide public health problem, and AF in association with valvular heart disease (VHD) is also common. However, management strategies for this group of patients have been less informed by randomized trials, which have largely focused on 'non-valvular AF' patients. Thrombo-embolic risk also varies according to valve lesion and may also be associated with CHA2DS2VASc score risk factor components, rather than only the valve disease being causal. Given marked heterogeneity in the definition of valvular and non-valvular AF and variable management strategies, including non-vitamin K antagonist oral anticoagulants (NOACs) in patients with VHD other than prosthetic heart valves or haemodynamically significant mitral valve disease, there is a need to provide expert recommendations for professionals participating in the care of patients presenting with AF and associated VHD. To address this topic, a Task Force was convened by the European Heart Rhythm Association (EHRA) and European Society of Cardiology (ESC) Working Group on Thrombosis, with representation from the ESC Working Group on Valvular Heart Disease, Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), South African Heart (SA Heart) Association and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLEACE) with the remit to comprehensively review the published evidence, and to publish a joint consensus document on the management of patients with AF and associated VHD, with up-to-date consensus recommendations for clinical practice for different forms of VHD. This consensus document proposes that the term 'valvular AF' is outdated and given that any definition ultimately relates to the evaluated practical use of oral anticoagulation (OAC) type, we propose a functional Evaluated Heartvalves, Rheumatic or Artificial (EHRA) categorization in relation to the type of OAC use in patients with AF, as follows: (i) EHRA Type 1 VHD, which refers
Young, Daniel K W; Kwok, Timothy C Y; Ng, Petrus Y N
Persons with mild dementia experience multiple losses and manifest depressive symptoms. This research study aimed to evaluate the effectiveness of a support group led by a social worker for Chinese persons with mild dementia. Participants were randomly assigned to either a ten-session support group or a control group. Standardized assessment tools were used for data collection at pretreatment and post-treatment periods by a research assistant who was kept blind to the group assignment of the participants. Upon completion of the study, 20 treatment group participants and 16 control group participants completed all assessments. At baseline, the treatment and control groups did not show any significant difference on all demographic variables, as well as on all baseline measures; over one-half (59%) of all the participants reported having depression, as assessed by a Chinese Geriatric Depression Scale score ≥8. After completing the support group, the depressive mood of the treatment group participants reduced from 8.83 (standard deviation =2.48) to 7.35 (standard deviation =2.18), which was significant (Wilcoxon signed-rank test; P=0.017, Pcontrol group's participants did not show any significant change. This present study supports the efficacy and effectiveness of the support group for persons with mild dementia in Chinese society. In particular, this present study shows that a support group can reduce depressive symptoms for participants.
In a RCT of family psychoeducation, 47 carers of 34 patients were allocated to one of three groups; Multifamily Group Psychoeducation, Solution Focussed Group Therapy or Treatment as Usual. Carers in both the MFGP intervention and the SFGP arm demonstrated greater knowledge and reduction in burden than those in the TAU arm.
Cornes, Michael P; Church, Stephen; van Dongen-Lases, Edmée; Grankvist, Kjell; Guimarães, João T; Ibarz, Mercedes; Kovalevskaya, Svetlana; Kristensen, Gunn Bb; Lippi, Giuseppe; Nybo, Mads; Sprongl, Ludek; Sumarac, Zorica; Simundic, Ana-Maria
Patient safety is a leading challenge in healthcare and from the laboratory perspective it is now well established that preanalytical errors are the major contributor to the overall rate of diagnostic and therapeutic errors. To address this, the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase (EFLM WG-PRE) was established to lead in standardization and harmonization of preanalytical policies and practices at a European level. One of the key activities of the WG-PRE is the organization of the biennial EFLM-BD conference on the preanalytical phase to provide a forum for National Societies (NS) to discuss their issues. Since 2012, a year after the first Preanalytical phase conference, there has been a rapid growth in the number of NS with a working group engaged in preanalytical phase activities and there are now at least 19 countries that have one. As a result of discussions with NS at the third conference held in March 2015 five key areas were identified as requiring harmonisation. These were test ordering, sample transport and storage, patient preparation, sampling procedures and management of unsuitable specimens. The article below summarises the work that has and will be done in these areas. The goal of this initiative is to ensure the EFLM WG-PRE produces work that meets the needs of the European laboratory medicine community. Progress made in the identified areas will be updated at the next preanalytical phase conference and show that we have produced guidance that has enhanced standardisation in the preanalytical phase and improved patient safety throughout Europe. © The Author(s) 2016.
Full Text Available Abstract Background Coping with a chronic illness (CI challenges children's psychosocial functioning and wellbeing. Cognitive-behavioral intervention programs that focus on teaching the active use of coping strategies may prevent children with CI from developing psychosocial problems. Involvement of parents in the intervention program may enhance the use of learned coping strategies in daily life, especially on the long-term. The primary aim of the present study is to examine the effectiveness of a cognitive behavioral based group intervention (called 'Op Koers' 1 for children with CI and of a parallel intervention for their parents. A secondary objective is to investigate why and for whom this intervention works, in order to understand the underlying mechanisms of the intervention effect. Methods/design This study is a multicentre randomized controlled trial. Participants are children (8 to 18 years of age with a chronic illness, and their parents, recruited from seven participating hospitals in the Netherlands. Participants are randomly allocated to two intervention groups (the child intervention group and the child intervention combined with a parent program and a wait-list control group. Primary outcomes are child psychosocial functioning, wellbeing and child disease related coping skills. Secondary outcomes are child quality of life, child general coping skills, child self-perception, parental stress, quality of parent-child interaction, and parental perceived vulnerability. Outcomes are evaluated at baseline, after 6 weeks of treatment, and at a 6 and 12-month follow-up period. The analyses will be performed on the basis of an intention-to-treat population. Discussion This study evaluates the effectiveness of a group intervention improving psychosocial functioning in children with CI and their parents. If proven effective, the intervention will be implemented in clinical practice. Strengths and limitations of the study design are discussed
Paun, O.; Schönswetter, P.; Winkler, M.; Tribsch, A.
Although many species have similar total distributional ranges, they might be restricted to very different habitats and might have different phylogeographic histories. In the European Alps, our excellent knowledge of the evolutionary history of silicate-dwelling (silicicole) plants is contrasted by a virtual lack of data from limestone-dwelling (calcicole) plants. These two categories exhibit fundamentally different distribution patterns within the Alps and are expected to differ strongly with respect to their glacial history. The calcicole Ranunculus alpestris group comprises three diploid species of alpine habitats. Ranunculus alpestris s. str is distributed over the southern European mountain system, while R. bilobus and R. traunfellneri are Southern Alpine narrow endemics. To explore their phylogenetic relationships and phylogeographic history, we investigated the correlation between information given by nuclear and chloroplast DNA data. Analyses of AFLP fingerprints and matK sequences gave incongruent results, indicative for reticulate evolution. Our data highlight historical episodes of range fragmentation and expansion, occasional long distance dispersal and on-going gene flow as important processes shaping the genetic structure of the group. Genetic divergence, expressed as a rarity index (“frequency-down-weighted marker values”) seems a better indicator of historical processes than patterns of genetic diversity, which rather mirror contemporary processes as connectivity of populations and population sizes. Three phylogeographical subgroups have been found within the R. alpestris group, neither following taxonomy nor geography. Genetic heterogeneity in the Southern Alps contrasts with Northern Alpine uniformity. The Carpathians have been stepwise colonised from the Eastern Alpine lineage resulting in a marked diversity loss in the Southern Carpathians. The main divergence within the group, separating the ancestor of the two endemic species from R
Kjellman, Görel; Oberg, Birgitta
Seventy-seven patients with neck pain in the primary health care were included in a prospective, randomized clinical trial and randomly assigned to general exercise, McKenzie treatment, or a control group. Seventy patients completed the treatment; response rate 93% at 12-month follow-up. All three groups showed significant improvement regarding the main outcomes, pain intensity and Neck Disability Index, even at 12-month follow-up, but there was no significant difference between the groups. In all, 79% reported that they were better or completely restored after treatment, although 51% reported constant/daily pain. In the McKenzie group compared with the control group, a tendency toward greater improvement was noted for pain intensity at 3 weeks and at 6-month follow-up, and for post-treatment Neck Disability Index. Significant improvement in Distress and Risk Assessment Method scores was shown in the McKenzie group only. The three groups had similar recurrence rates, although after 12 months the McKenzie group showed a tendency toward fewer visits for additional health care. The study did not provide a definite evidence of treatment efficacy in patients with neck pain, however, there was a tendency toward a better outcome with the two active alternatives compared with the control group.
Nair, Nirmala; Tripathy, Prasanta; Sachdev, H S; Pradhan, Hemanta; Bhattacharyya, Sanghita; Gope, Rajkumar; Gagrai, Sumitra; Rath, Shibanand; Rath, Suchitra; Sinha, Rajesh; Roy, Swati Sarbani; Shewale, Suhas; Singh, Vijay; Srivastava, Aradhana; Costello, Anthony; Copas, Andrew; Skordis-Worrall, Jolene; Haghparast-Bidgoli, Hassan; Saville, Naomi; Prost, Audrey
Around 30% of the world's stunted children live in India. The Government of India has proposed a new cadre of community-based workers to improve nutrition in 200 districts. We aimed to find out the effect of such a worker carrying out home visits and participatory group meetings on children's linear growth. We did a cluster-randomised controlled trial in two adjoining districts of Jharkhand and Odisha, India. 120 clusters (around 1000 people each) were randomly allocated to intervention or control using a lottery. Randomisation took place in July, 2013, and was stratified by district and number of hamlets per cluster (0, 1-2, or ≥3), resulting in six strata. In each intervention cluster, a worker carried out one home visit in the third trimester of pregnancy, monthly visits to children younger than 2 years to support feeding, hygiene, care, and stimulation, as well as monthly women's group meetings to promote individual and community action for nutrition. Participants were pregnant women identified and recruited in the study clusters and their children. We excluded stillbirths and neonatal deaths, infants whose mothers died, those with congenital abnormalities, multiple births, and mother and infant pairs who migrated out of the study area permanently during the trial period. Data collectors visited each woman in pregnancy, within 72 h of her baby's birth, and at 3, 6, 9, 12, and 18 months after birth. The primary outcome was children's length-for-age Z score at 18 months of age. Analyses were by intention to treat. Due to the nature of the intervention, participants and the intervention team were not masked to allocation. Data collectors and the data manager were masked to allocation. The trial is registered as ISCRTN (51505201) and with the Clinical Trials Registry of India (number 2014/06/004664). Between Oct 1, 2013, and Dec 31, 2015, we recruited 5781 pregnant women. 3001 infants were born to pregnant women recruited between Oct 1, 2013, and Feb 10, 2015
European Committee for Future Accelerators (ECFA)
This document contains two reports on the use of microprocessors in European High-Energy Physics experiments. The first is a presentation of data collected by a sub-group of the ECFA working group on data procesing standards. The working group is organised by E. Lillestol, University of Bergen and E.M. Rimmer, CERN, DD Division; the Microprocessor sub-group organiser is L.O. Hertzberger, NIKHEF, Amsterdam. Data are given from projects numbered 81 - 194, and some CERN projects are included. Even though there is some duplication of information, a second report has been appended which covers a wider range of CERN projects. This was the result of a microprocessor survey made at CERN by P. Scharff-Hansen, DD Division, at the request of E. Gabthuler. The ECFA working group intends to have reports for all the sub-groups (10 in number) available in machine-readable form at the CERN computer centre. However, it was felt that the information herein is most valuable to designers and users of microprocessors, and that it...
Full Text Available Cluster randomized trials assess the effect of an intervention that is carried out at the group or cluster level. Ajzen’s theory of planned behaviour is often used to model the effect of the intervention as an indirect effect mediated in turn by attitude, norms and behavioural intention. Structural equation modelling (SEM is the technique of choice to estimate indirect effects and their significance. However, this is a large sample technique, and its application in a cluster randomized trial assumes a relatively large number of clusters. In practice, the number of clusters in these studies tends to be relatively small, e.g. much less than fifty. This study uses simulation methods to find the lowest number of clusters needed when multilevel SEM is used to estimate the indirect effect. Maximum likelihood estimation is compared to Bayesian analysis, with the central quality criteria being accuracy of the point estimate and the confidence interval. We also investigate the power of the test for the indirect effect. We conclude that Bayes estimation works well with much smaller cluster level sample sizes such as 20 cases than maximum likelihood estimation; although the bias is larger the coverage is much better. When only 5 to 10 clusters are available per treatment condition even with Bayesian estimation problems occur.
Tan, Shuping; Zou, Yizhuang; Wykes, Til; Reeder, Clare; Zhu, Xiaolin; Yang, Fude; Zhao, Yanli; Tan, Yunlong; Fan, Fengmei; Zhou, Dongfeng
Individual-level cognitive remediation therapy (CRT) has been shown to be effective for cognitive improvement and social function amelioration. Here, we aimed to test the efficacy of group-based CRT in Chinese subjects with schizophrenia. One-hundred and four inpatients were randomly assigned to either 40 sessions of small-group CRT therapy or therapeutic contact-matched Musical and Dancing Therapy (MDT). Cognitive and social functioning, as well as clinical symptoms, were evaluated over the course of treatment. Specifically, cognitive function was evaluated using a battery of cognitive measurements, clinical symptoms were evaluated using the Positive and Negative Syndrome Scale, and social function was evaluated using the Nurse's Observation Scale for Inpatient Evaluation-30. All patients were evaluated pre- and post-treatment. Forty-four individuals in the CRT group and 46 in the MDT group completed all of the planned treatments and analyses. Cognitive functions, especially cognitive flexibility and memory, showed significant improvement in the CRT group over the course of the study. The MDT group also showed improvement in several cognitive flexibility assessments, but the degree of improvement was significantly greater in the CRT group. Several social-function factors exhibited a significant improvement in the CRT group, but not in the MDT group. Cognitive function improvement correlated positively with social function without predicting social function change. We conclude that group-based CRT is an effective and promising therapy. Copyright © 2016. Published by Elsevier Ireland Ltd.
Moher, David; Hopewell, Sally; Schulz, Kenneth F
to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement. After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update...... of the CONSORT statement-has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. The CONSORT 2010 Statement...
Moher, David; Hopewell, Sally; Schulz, Kenneth F
to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement. After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update...... of the CONSORT statement-has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. The CONSORT 2010 Statement...
Tazeen H Jafar
Full Text Available Evidence on long term effectiveness of public health strategies for lowering blood pressure (BP is scarce. In the Control of Blood Pressure and Risk Attenuation (COBRA Trial, a 2 x 2 factorial, cluster randomized controlled trial, the combined home health education (HHE and trained general practitioner (GP intervention delivered over 2 years was more effective than no intervention (usual care in lowering systolic BP among adults with hypertension in urban Pakistan. However, it was not clear whether the effect would be sustained after the cessation of intervention. We conducted 7 years follow-up inclusive of 5 years of post intervention period of COBRA trial participants to assess the effectiveness of the interventions on BP during extended follow-up.A total of 1341 individuals 40 years or older with hypertension (systolic BP 140 mm Hg or greater, diastolic BP 90 mm Hg or greater, or already receiving treatment were followed by trained research staff masked to randomization status. BP was measured thrice with a calibrated automated device (Omron HEM-737 IntelliSense in the sitting position after 5 minutes of rest. BP measurements were repeated after two weeks. Generalized estimating equations (GEE were used to analyze the primary outcome of change in systolic BP from baseline to 7- year follow-up. The multivariable model was adjusted for clustering, age at baseline, sex, baseline systolic and diastolic BP, and presence of diabetes.After 7 years of follow-up, systolic BP levels among those randomised to combined HHE plus trained GP intervention were significantly lower (2.1 [4.1-0.1] mm Hg compared to those randomised to usual care, (P = 0.04. Participants receiving the combined intervention compared to usual care had a greater reduction in LDL-cholesterol (2.7 [4.8 to 0.6] mg/dl.The benefit in systolic BP reduction observed in the original cohort assigned to the combined intervention was attenuated but still evident at 7- year follow-up. These
28 June 2012 - Members of the European Brain Council led by President Mary Baker visiting the LHC tunnel at Point 5 with Technology Department Group Leader L. Bottura and CMS experimental area with Run Coordinator M. Chamizo-Llatas.
28 June 2012 - Members of the European Brain Council led by President Mary Baker visiting the LHC tunnel at Point 5 with Technology Department Group Leader L. Bottura and CMS experimental area with Run Coordinator M. Chamizo-Llatas.
Schaap, Maartje M; Kunst, Anton E; Leinsalu, Mall
BACKGROUND: Recently a scale was introduced to quantify the implementation of tobacco control policies at country level. Our study used this scale to examine the potential impact of these policies on quit ratios in European countries. Special attention was given to smoking cessation among lower...... and Latvia. Higher educated smokers were more likely to have quit smoking than lower educated smokers in all age-sex groups in all countries. National score on the tobacco control scale was positively associated with quit ratios in all age-sex groups. The association of quit ratios with score on TCS did...... not show consistent differences between high and low educated. Of all tobacco control policies of which the TCS is constructed, price policies showed the strongest association with quit ratios, followed by an advertising ban. CONCLUSION: Countries with more developed tobacco control policies have higher...
Full Text Available Abstract Background Internet administered cognitive behaviour therapy (CBT is a promising new way to deliver psychological treatment, but its effectiveness in regular care settings and in relation to more traditional CBT group treatment has not yet been determined. The primary aim of this study was to compare the effectiveness of Internet-and group administered CBT for panic disorder (with or without agoraphobia in a randomised trial within a regular psychiatric care setting. The second aim of the study was to establish the cost-effectiveness of these interventions. Methods Patients referred for treatment by their physician, or self-referred, were telephone-screened by a psychiatric nurse. Patients fulfilling screening criteria underwent an in-person structured clinical interview carried out by a psychiatrist. A total of 113 consecutive patients were then randomly assigned to 10 weeks of either guided Internet delivered CBT (n = 53 or group CBT (n = 60. After treatment, and at a 6-month follow-up, patients were again assessed by the psychiatrist, blind to treatment condition. Results Immediately after randomization 9 patients dropped out, leaving 104 patients who started treatment. Patients in both treatment conditions showed significant improvement on the main outcome measure, the Panic Disorder Severity Scale (PDSS after treatment. For the Internet treatment the within-group effect size (pre-post on the PDSS was Cohen's d = 1.73, and for the group treatment it was d = 1.63. Between group effect sizes were low and treatment effects were maintained at 6-months follow-up. We found no statistically significant differences between the two treatment conditions using a mixed models approach to account for missing data. Group CBT utilised considerably more therapist time than did Internet CBT. Defining effect as proportion of PDSS responders, the cost-effectiveness analysis concerning therapist time showed that Internet treatment had superior cost
Background Studies show the effectiveness of group psychoeducation in reducing symptoms in people with depression. However, few controlled studies that have included aspects of personal care and healthy lifestyle (diet, physical exercise, sleep) together with cognitive-behavioral techniques in psychoeducation are proven to be effective. The objective of this study is to assess the effectiveness of a psychoeducational program, which includes aspects of personal care and healthy lifestyle, in patients with mild/moderate depression symptoms in Primary Care (PC). Methods In a randomized, controlled trial, 246 participants over 20 years old with ICD-10 major depression were recruited through nurses/general practitioners at 12 urban Primary Care Centers (PCCs) in Barcelona. The intervention group (IG) (n=119) received a group psychoeducational program (12 weekly, 1.5 h sessions led by two nurses) and the control group (CG) (n=112) received usual care. Patients were assessed at baseline and at, 3, 6 and 9 months. The main outcome measures were the BDI, EQ-5D and remission based upon the BDI. Results 231 randomized patients were included, of whom 85 had mild depression and 146 moderate depression. The analyses showed significant differences between groups in relation to remission of symptoms, especially in the mild depression group with a high rate of 57% (p=0.009) at post-treatment and 65% (p=0.006) at 9 month follow up, and only showed significant differences on the BDI at post-treatment (p=0.016; effect size Cohen’s d’=.51) and at 6 and 9 month follow-up (p= 0.048; d’=.44). In the overall and moderate sample, the analyses only showed significant differences between groups on the BDI at post-treatment, p=0.02 (d’=.29) and p=0.010 (d’=.47), respectively. The psychoeducation group improved significantly on the EQ-5D at short and long-term. Conclusions This psychoeducational intervention is a short and long-term effective treatment for patients with mild
Bernstein, Judith A; Bernstein, Edward; Heeren, Timothy C
Reductions in control group consumption over time that are possibly related to research design affect the impact of brief alcohol interventions (BAI) in clinical settings. We conducted a systematic review to identify research design factors that may contribute to control group change, strategies to limit these effects and implications for researchers. Studies with control group n > 30 were selected if they published baseline and outcome consumption data, conducted trials in clinical settings in Anglophone countries and did not censor gender or age. Among 38 studies cited in 20 reviews through October 2009, 16 met criteria (n = 31-370). In 54%, controls received alcohol specific handouts, advice and/or referral. Both the number and depth of assessments were highly variable. The percentage change in consumption ranged from-0.10 to-0.84 (mean-0.32), and effect size from 0.04 to 0.70 (mean 0.37). Published data were insufficient for meta-analysis. Researchers should consider strategies to reduce the impact of research design factors, such as procedures to enhance sample diversity, blind subjects to study purpose to limit social desirability bias, reduce the number and depth of instruments (assessment reactivity), and finally, analytic techniques to decrease the impact of outliers and regression to the mean. This review identifies problems with retrospective analysis of predictors of control group change, and underscores the need to design prospective studies to permit identification, quantification and adjustment for potential sources of bias in BAI trials.
Nottelmann, Lise; Groenvold, Mogens; Vejlgaard, Tove Bahn
is the primary outcome measure of the study. Secondary outcome measures include survival and economic consequences. DISCUSSION: To our knowledge the Pal-Rehab study is the first randomized, controlled, phase III trial to evaluate individually tailored, palliative rehabilitation in standard oncology care......BACKGROUND: The effect of early palliative care and rehabilitation on the quality of life of patients with advanced cancer has been only sparsely described and needs further investigation. In the present trial we combine elements of early, specialized palliative care with cancer rehabilitation....... The patients are randomized to a specialized palliative rehabilitation intervention integrated in standard oncology care or to standard oncology care alone. The intervention consists of a multidisciplinary group program, individual consultations, or a combination of both. At baseline and after six and 12 weeks...
Kirkeby, Carsten; Dominiak, Patrycja
Culicoides gornostaevae Mirzaeva, 1984, known previously only from Siberia, is a boreal species included into the Obsoletus group of Culicoides sg. Avaritia. Members of the subgenus can act as vectors of various diseases. In Europe they are involved in the transmission of the Schmallenberg virus...
Miralbell, R.; Mornex, F.; Greiner, R.; Bolla, M.; Storme, G.; Hulshof, M.; Bernier, J.; Denekamp, J.; Rojas, A. M.; Pierart, M.; van Glabbeke, M.; Mirimanoff, R. O.
A three-step phase I/II trial associating accelerated radiotherapy with carbogen (step 1, ARCO), with nicotinamide (step 2, ARN), or with both (step 3, ARCON) was conducted, the aim of which was to overcome the effects of proliferation and hypoxia as potential causes of tumor radioresistance in
Fischer, M.; Wernike, K.; Freuling, C.M.; Müller, T.; Aylan, O.; Brochier, B.; Cliquet, F.; Vázquez-Morón, S.; Hostnik, P.; Huovilainen, A.; Isaksson, M.; Kooi, E.A.
Rabies is a lethal and notifiable zoonotic disease for which diagnostics have to meet the highest standards. In recent years, an evolution was especially seen in molecular diagnostics with a wide variety of different detection methods published. Therefore, a first international ring trial
Vesterdal, Lars; Muhie Dawud, Seid; Raulund-Rasmussen, Karsten; Finér, Leena; Domisch, Timo; Ratcliffe, Sophia
The influence of tree species diversity and functional group on soil properties (carbon stock, pH and C/N ratio) has not been explored across major European forest types. We evaluated the relative importance of tree species diversity and functional group on soil carbon (C) stocks, C/N ratio and pH in major European forest types in the six regions Finland, Poland, Germany, Romania, Italy and Spain. We sampled soils in 209 permanent plots along a species diversity gradient from monocultures to 5-species mixtures in the exploratory platform of the FunDivEurope project. Carbon stocks in the topsoil (forest floor (FF), 0-10 cm, and FF+0-10 cm) were positively, but weakly, related to diversity across the regions. While the C/N ratio in the FF+0-10 cm layer decreased significantly with increasing diversity in the Spanish region, pH was unrelated to species diversity across the regions. Tree species functional group (conifer proportion) explained a larger proportion of the variability in soil properties than species diversity. Conifer admixture increased C stock and C/N ratio, and decreased pH, but the impacts differed between the regions for some soil layers. Differences in mean annual temperature, actual evapotranspiration and soil texture between the regions were possible driving factors behind the different functional group effects in Finland, Spain and Germany. The results suggest that targeted selection of tree species with desired characteristics, e.g. complementary traits for resource use, is a preferred management approach for influencing soil C stock, C/N ratio and pH in mixed forests rather than increasing tree species diversity per se.
Full Text Available Daniel KW Young,1 Timothy CY Kwok,2 Petrus YN Ng1 1Department of Social Work, Hong Kong Baptist University, Kowloon Tong, Hong Kong; 2Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong Purpose: Persons with mild dementia experience multiple losses and manifest depressive symptoms. This research study aimed to evaluate the effectiveness of a support group led by a social worker for Chinese persons with mild dementia. Research methods: Participants were randomly assigned to either a ten-session support group or a control group. Standardized assessment tools were used for data collection at pretreatment and post-treatment periods by a research assistant who was kept blind to the group assignment of the participants. Upon completion of the study, 20 treatment group participants and 16 control group participants completed all assessments. Results: At baseline, the treatment and control groups did not show any significant difference on all demographic variables, as well as on all baseline measures; over one-half (59% of all the participants reported having depression, as assessed by a Chinese Geriatric Depression Scale score ≥8. After completing the support group, the depressive mood of the treatment group participants reduced from 8.83 (standard deviation =2.48 to 7.35 (standard deviation =2.18, which was significant (Wilcoxon signed-rank test; P=0.017, P<0.05, while the control group’s participants did not show any significant change. Conclusion: This present study supports the efficacy and effectiveness of the support group for persons with mild dementia in Chinese society. In particular, this present study shows that a support group can reduce depressive symptoms for participants. Keywords: support group, mild dementia, Chinese, depression
Full Text Available We investigated the effects of group music intervention on aggression and self-esteem in children with highly aggressive behavior. Forty-eight children were allocated to either a music intervention group or an untreated control group. The music intervention group received 50 min of music intervention twice weekly for 15 consecutive weeks. The outcome measures were Child Behavior Checklist Aggression Problems Scale (Parents, Child Aggression Assessment Inventory (Teachers and Rosenberg Self-esteem Scale. After 15 weeks, the music intervention group showed significant reduction of aggression and improvement of self-esteem compared with the control group. All outcome measures were significantly lower in the music intervention group than prior to treatment, while there was no change in the control group. These findings suggest that music can reduce aggressive behavior and improve self-esteem in children with highly aggressive behavior. Music intervention is an easily accessible therapy for children and as such may be an effective intervention for aggressive behavior. Further more, objective and replicable measures are required from a randomized controlled trial with a larger sample size and active comparable control.
Full Text Available Abstract Background Sub-optimal parenting is a common risk factor for a wide range of negative health, social and educational outcomes. Most parenting programmes have been developed in the USA in the context of delinquency prevention for targeted or indicated groups and the main theoretical underpinning for these programmes is behaviour management. The Family Links Nurturing Programme (FLNP focuses on family relationships as well as behaviour management and is offered on a universal basis. As a result it may be better placed to improve health and educational outcomes. Developed in the UK voluntary sector, FLNP is popular with practitioners, has impressed policy makers throughout the UK, has been found to be effective in before/after and qualitative studies, but lacks a randomised controlled trial (RCT evidence base. Methods/Design A multi-centre, investigator blind, randomised controlled trial of the FLNP with a target sample of 288 south Wales families who have a child aged 2-4 yrs living in or near to Flying Start/Sure Start areas. Changes in parenting, parent child relations and parent and child wellbeing are assessed with validated measures immediately and at 6 months post intervention. Economic components include cost consequences and cost utility analyses based on parental ranking of states of quality of life. Attendance and completion rates and fidelity to the FLNP course delivery are assessed. A nested qualitative study will assess reasons for participation and non-participation and the perceived value of the programme to families. By the end of May 2010, 287 families have been recruited into the trial across four areas of south Wales. Recruitment has not met the planned timescales with barriers including professional anxiety about families entering the control arm of the trial, family concern about video and audio recording, programme facilitator concern about the recording of FLNP sessions for fidelity purposes and delays due to the
Short-term intensive psychodynamic group therapy versus cognitive-behavioral group therapy in day treatment of anxiety disorders and comorbid depressive or personality disorders: study protocol for a randomized controlled trial.
Suszek, Hubert; Holas, Paweł; Wyrzykowski, Tomasz; Lorentzen, Steinar; Kokoszka, Andrzej
Psychodynamic and cognitive-behavioral group therapies are frequently applied in day hospitals for the treatment of anxiety disorders and comorbid depressive or personality disorders in Poland and other Eastern European countries. Yet there is not enough evidence as to their effectiveness in this environment; this study addresses this gap. The aim of the study is to determine the effectiveness of these two kinds of day treatment care consisting of intensive, short-term group psychodynamic and cognitive-behavioral therapy, for patients with anxiety disorders and/or comorbid depressive or personality disorders. Our objectives are to: 1) show the effectiveness of each treatment in a day-care setting relative to the wait-list control group; 2) demonstrate the relative short- and long-term effectiveness of the two active treatments; 3) carry out a preliminary examination of the predictors and moderators of treatment response; 4) carry out a preliminary examination of the mediators of therapeutic change; and 5) compare the impact of both methods of treatment on the outcome of the measures used in this study. In this randomized controlled trial, a total of 199 patients with anxiety disorders and comorbid depressive and/or personality disorders will be assigned to one of three conditions: 1) psychodynamic group therapy; 2) cognitive-behavioral group therapy; or 3) wait-list control group. The therapy will last 12 weeks. Both treatments will be manualized (the manuals will address comorbidity). Primary outcome measures will include self-reported symptoms of anxiety, observer-rated symptoms of anxiety, global improvement, and recovery rate. Secondary outcome measures will include the number of pathological personality traits, depression, self-esteem, defense mechanisms, beliefs about self and others, interpersonal problems, object relations, parental bonding, meta-cognition, and quality of life. Measures will be taken at baseline, post-treatment, and at six months following
Simmons, David; Jelsma, Judith G M; Galjaard, Sander; Devlieger, Roland; van Assche, Andre; Jans, Goele; Corcoy, Rosa; Adelantado, Juan M; Dunne, Fidelma; Desoye, Gernot; Harreiter, Jürgen; Kautzky-Willer, Alexandra; Damm, Peter; Mathiesen, Elisabeth R; Jensen, Dorte M; Andersen, Lise Lotte; Lapolla, Annunziata; Dalfra, Maria; Bertolotto, Alessandra; Wender-Ozegowska, Ewa; Zawiejska, Agnieszka; Hill, David; Rebollo, Pablo; Snoek, Frank J; van Poppel, Mireille N M
Ways to prevent gestational diabetes mellitus (GDM) remain unproven. We compared the impact of three lifestyle interventions (healthy eating [HE], physical activity [PA], and both HE and PA [HE+PA]) on GDM risk in a pilot multicenter randomized trial. Pregnant women at risk for GDM (BMI ≥29 kg/m2) from nine European countries were invited to undertake a 75-g oral glucose tolerance test before 20 weeks' gestation. Those without GDM were randomized to HE, PA, or HE+PA. Women received five face-to-face and four optional telephone coaching sessions, based on the principles of motivational interviewing. A gestational weight gain (GWG) Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.
The abundance of evidence supporting beta-blocker therapy has resulted in the widespread acceptance of these drugs in the treatment of heart-failure patients. However, beta-blockers are not a homogeneous class of drugs, and important differences in efficacy have been noted between different members of the class. Thus, practicing physicians are faced with a choice when selecting a particular beta-blocker for treating heart failure. One of the considerations is whether to choose a selective or a nonselective beta-blocker. The results of the Carvedilol or Metoprolol European Trial indicate that carvedilol, a third-generation, nonselective beta-blocker with additional a-blocking, antioxidant, and other properties, is clearly superior to a beta1-blocking drug, metoprolol tartrate. The choice between these drugs is therefore unambiguously in favor of carvedilol.
Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient Care Committee & Adherence Working Group of the Outcomes Committee of the Adult AIDS Clinical Trials Group (AACTG).
Chesney, M A; Ickovics, J R; Chambers, D B; Gifford, A L; Neidig, J; Zwickl, B; Wu, A W
This paper describes the AACTG Adherence Instruments, which are comprised of two self-report questionnaires for use in clinical trials conducted by the Adult AIDS Clinical Trials Group (AACTG). The questionnaires were administered to 75 patients at ten AACTG sites in the USA. All patients were taking combination antiretroviral therapy (ART), including at least one protease inhibitor. Eleven per cent of patients reported missing at least one dose the day before the interview, and 17% reported missing at least one dose during the two days prior. The most common reasons for missing medications included 'simply forgot' (66%) and a number of factors often associated with improved health, including being busy (53%), away from home (57%) and changes in routine (51%). Less adherent patients reported lower adherence self-efficacy (p = 0.006) and were less sure of the link between non-adherence and the development of drug resistance (p = 0.009). They were also more likely to consume alcohol, to be employed outside the home for pay and to have enrolled in clinical trials to gain access to drugs (all p USA and abroad.
Camacho, E M; Ntais, D; Jones, S; Riste, L; Morriss, R; Lobban, F; Davies, L M
Bipolar disorder (BD) costs the English economy an estimated £5.2billion/year, largely through incomplete recovery. This analysis estimated the cost-effectiveness of group psychoeducation (PEd), versus group peer support (PS), for treating BD. A 96-week pragmatic randomised controlled trial (RCT), conducted in NHS primary care. The primary analysis compared PEd with PS, using multiple imputed datasets for missing values. An economic model was used to compare PEd with treatment as usual (TAU). The perspective was Health and Personal Social Services. Participants receiving PEd (n=153) used more (costly) health-related resources than PS (n=151) (net cost per person £1098 (95% CI, £252-£1943)), with a quality-adjusted life year (QALY) gain of 0.023 (95% CI, 0.001-0.056). The cost per QALY gained was £47,739. PEd may be cost-effective (versus PS) if decision makers are willing to pay at least £37,500 per QALY gained. PEd costs £10,765 more than PS to avoid one relapse. The economic model indicates that PEd may be cost-effective versus TAU if it reduces the probability of relapse (by 15%) or reduces the probability of and increases time to relapse (by 10%). Participants were generally inconsistent in attending treatment sessions and low numbers had complete cost/QALY data. Factors contributing to pervasive uncertainty of the results are discussed. This is the first economic evaluation of PEd versus PS in a pragmatic trial. PEd is associated with a modest improvement in health status and higher costs than PS. There is a high level of uncertainty in the data and results. Copyright © 2017 Elsevier B.V. All rights reserved.
van der Spek, N; Vos, J; van Uden-Kraan, C F; Breitbart, W.; Cuijpers, P; Holtmaat, K; Witte, B I; Tollenaar, R.A.E.M.; Verdonck-de Leeuw, I M
BACKGROUND: The aim of this study was to assess the efficacy of meaning-centered group psychotherapy for cancer survivors (MCGP-CS) to improve personal meaning, compared with supportive group psychotherapy (SGP) and care as usual (CAU). METHOD: A total of 170 cancer survivors were randomly assigned
Full Text Available Two hundred thirty-eight first-year college students were assessed using the Beck Depression Inventory (BDI. Thirty students meeting the BDI criteria for moderate to severe depression were randomly assigned to either a treatment or control group. The treatment group received four 90-minute group sessions of EFT (Emotional Freedom Techniques, a novel treatment that combines exposure, cognitive reprocessing, and somatic stimulation. The control group received no treatment. Posttests were conducted 3 weeks later on those that completed all requirements (N=18. The EFT group (n=9 had significantly more depression at baseline than the control group (n=9 (EFT BDI mean=23.44, SD=2.1 versus control BDI mean=20.33, SD=2.1. After controlling for baseline BDI score, the EFT group had significantly less depression than the control group at posttest, with a mean score in the “nondepressed” range (P=.001; EFT BDI mean=6.08, SE=1.8 versus control BDI mean=18.04, SE=1.8. Cohen's d was 2.28, indicating a very strong effect size. These results are consistent with those noted in other studies of EFT that included an assessment for depression and indicate the clinical usefulness of EFT as a brief, cost-effective, and efficacious treatment.
Petry, Nancy M.; Weinstock, Jeremiah; Alessi, Sheila M.; Lewis, Marilyn W.; Dieckhaus, Kevin
Objective: Contingency management (CM) treatments are usually applied individually for drug abstinence, but CM can also be targeted toward health behaviors and implemented in groups. This study evaluated effects of a group-based CM intervention that focused on reinforcing health behaviors. Method: HIV-positive patients with cocaine or opioid use…
Currie, Michael; Startup, Mike
This study evaluates efficacy and effectiveness of "Doing Anger Differently" (DAD), a group treatment for reactively aggressive 12-15 year old males. DAD uses percussion exercises to aid treatment. Study 1 compared a ten-week treatment with a waitlist control at pre, post and 6 month (treatment group only) follow-up. Study 2 replicated Study 1,…
This is the story of the remarkable psychologist John E. Coover, who, in the early 1900s, was the first to advocate the comparison of experimental and control ol groups as a methodological necessity. Moreover, the author raises the issue of why control groups were launched about a century ago, and
Full Text Available BACKGROUND: Cohort studies are recommended for understanding ethnic disparities in cardiovascular disease. Our objective was to review the process for identifying, including, and excluding ethnic minority populations in published cardiovascular cohort studies in Europe and North America. METHODS AND FINDINGS: We found the literature using Medline (1966-2005, Embase (1980-2001, Cinahl, Web of Science, and citations from references; consultations with colleagues; Internet searches; and RB's personal files. A total of 72 studies were included, 39 starting after 1975. Decision-making on inclusion and exclusion of racial/ethnic groups, the conceptual basis of race/ethnicity, and methods of classification of racial/ethnic groups were rarely explicit. Few publications provided details on the racial/ethnic composition of the study setting or sample, and 39 gave no description. Several studies were located in small towns or in occupational settings, where ethnic minority populations are underrepresented. Studies on general populations usually had too few participants for analysis by race/ethnicity. Eight studies were explicitly on Caucasians/whites, and two excluded ethnic minority groups from the whole or part of the study on the basis of language or birthplace criteria. Ten studies were designed to compare white and nonwhite populations, while five studies focused on one nonwhite racial/ethnic group; all 15 of these were performed in the US. CONCLUSIONS: There is a shortage of information from cardiovascular cohort studies on racial/ethnic minority populations, although this has recently changed in the US. There is, particularly in Europe, an inequity resulting from a lack of research data in nonwhite populations. Urgent action is now required in Europe to address this disparity.
Conaway, Mark R
We propose a design for dose finding for cytotoxic agents in completely or partially ordered groups of patients. By completely ordered groups, we mean that prior to the study, there is clinical information that would indicate that for a given dose, the groups can be ordered with respect to the probability of toxicity at that dose. With partially ordered groups, at a given dose, only some of the groups can be ordered with respect to the probability of toxicity at that dose. The method we propose includes elements of the parametric model used in the continual reassessment method combined with the Hwang-Peddada order-restricted estimation procedure. We evaluate the operating characteristics of these designs in a family of dose-toxicity curves representing complete and partial orders. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.
Victoria Cerezo, M; Ortiz-Tallo, Margarita; Cardenal, Violeta; De La Torre-Luque, Alejandro
This study assessed the effects of a psychological group intervention based on positive psychology in women with breast cancer. 175 women were randomly assigned either to an experimental group, receiving the 14-session intervention (n = 87), or to a wait list group (n = 88) that did not receive any type of intervention. For treatment, a group intervention was applied, based on improving psychological strengths and enhancing positive psychology-based styles of coping. Strength-related outcomes, self-esteem, well-being, and happiness were assessed before and after the intervention. The experimental group showed higher scores on all of the study variables after the intervention. Participants reported improved self-esteem, emotional intelligence-related abilities, resilience, and optimism, as well as positive affectivity, well-being, and happiness. The results show a beneficial effect of this psychological intervention based on positive psychology on female breast cancer patients' psychological health.
Full Text Available This contribution asks whether sub-regional integration projects such as the Visegrád Group may be understood as mechanisms for pursuing one Group member’s national interests while it stands at the European Union’s helm. I assess this question based on the case of the first Visegrád Group member to assume the EU Council presidency: the Czech Republic. Examining three specific policy areas – the reinvention of the EU’s Eastern neighbourhood policy; the strengthening of EU energy security; and the incorporation of a stronger human rights and external democratisation approach into EU foreign policy – this case study presents a mixed picture. It confirms the potential of the Visegrád Group to be a vehicle for furthering the national preferences of one Group member while it holds the rotating EU Council presidency. Whether or not this potential is fully realised will depend primarily on the degree to which the interests of the four Visegrád countries converge.
Rahmani, Farnaz; Ebrahimi, Hossein; Ranjbar, Fatemeh; Razavi, Seyed Sajjad; Asghari, Elnaz
Introduction: Medication nonadherence is highly prevalent in patients with bipolar disorders and often results in worsening disease prognosis. The purpose of this study was to investigate the effect of group psychoeducation on medication adherence in female patients with bipolar mood disorder type I. Methods: This randomized controlled trial was conducted on 76 patients with bipolar mood disorder admitted in female psychiatric wards of Razi teaching hospital, Tabriz, Iran. The participants were selected by convenience sampling method and were randomly assigned to experimental and control groups. Patients in experimental group received 10 continuous 90 minutes sessions of psychoeducation, two times a week. Medication adherence was measured using the medicine check list and medication adherence rating scale (MARS) before and after intervention. Data analysis was performed with SPSS ver.13. Results: There was no significant difference between two groups regarding medication adherence before the intervention. After the study intervention, the mean scores of medication adherence check list and medication adherence rating scale in the experimental group were significantly higher than the control group. Conclusion: Since group psychoeducation was effective in improving patients' medication adherence, it could be recommended for psychiatric nurses to apply this intervention in the clinical setting.
Full Text Available Introduction: Medication nonadherence is highly prevalent in patients with bipolar disorders and often results in worsening disease prognosis. The purpose of this study was to investigate the effect of group psychoeducation on medication adherence in female patients with bipolar mood disorder type I. Methods: This randomized controlled trial was conducted on 76 patients with bipolar mood disorder admitted in female psychiatric wards of Razi teaching hospital, Tabriz, Iran. The participants were selected by convenience sampling method and were randomly assigned to experimental and control groups. Patients in experimental group received 10 continuous 90 minutes sessions of psychoeducation, two times a week. Medication adherence was measured using the medicine check list and medication adherence rating scale (MARS before and after intervention. Data analysis was performed with SPSS ver.13. Results: There was no significant difference between two groups regarding medication adherence before the intervention. After the study intervention, the mean scores of medication adherence check list and medication adherence rating scale in the experimental group were significantly higher than the control group. Conclusion: Since group psychoeducation was effective in improving patients' medication adherence, it could be recommended for psychiatric nurses to apply this intervention in the clinical setting.
Full Text Available Introduction: Suicide is a great economical, social and public health problem. It is prevalent worldwide and has a lot of negative effects on individuals, families and society. Depression is often prelude to Suicide. An important part of the treatment of the mentally ill patients is spiritual-religious psychotherapy which should be done after physical treatment. The aim of this study was to determine the effect of spiritual and religious group psychotherapy on suicidal ideation in depressed patients. Methods: 51 depressed patients with suicidal ideation from Razi hospital (Tabriz, Iran participated in this clinical trial. To collect Data questionnaire was used which included demographic and Beck Suicide Scale Ideation. Experimental group participated in 10 sessions of group psychotherapy. Each section lasted 1 hour. Two weeks after the last section post test was done. Statistical software SPSS ver 13 was used for data analysis. Results: Results of independent t-test revealed no difference between two groups in terms of suicidal ideation before intervention but after study there is a statistical difference. Also the results of ANCOVA test showed a significant relationship between spiritual group therapy and decrease in suicidal ideation, so that this intervention can make 57% of variance in suicidal ideation of experimental group.Conclusion: Regarding positive effect of spiritual and religious group psychotherapy on decreasing suicidal ideation of depressed patients, we suggest this intervention to be held in Psychiatric Wards and also more study on depression and other psychiatric patients with greater sample size would be helpful.
Bartlett, Delwyn; Wong, Keith; Richards, Dianne; Moy, Emma; Espie, Colin A; Cistulli, Peter A; Grunstein, Ronald
To examine whether a social cognitive therapy (SCT) intervention increases continuous positive airway pressure (CPAP) use compared to equivalent social interaction (SI) time. Individuals with obstructive sleep apnea (OSA) referred for CPAP therapy. Participants received a 30-min group education session regarding OSA and CPAP. Groups of three to four participants were then randomly assigned to an SCT session or social interaction. CPAP usage was assessed at 7 nights, then 1, 3, and 6 months. The two primary outcomes were adherence, usage ≥ 4 h per night at 6 months, and uptake of CPAP. Questionnaires were given pretreatment and posttreatment. Two hundred six individuals were randomized to SI (n = 97) or SCT (n = 109). CPAP uptake was not different between groups (82% in SI, 88% in SCT groups, P = 0.35). There were no differences between groups in adherence: 63-66% at 1 week, and at 6 months 55-47% (P = 0.36). Higher pretreatment apnea-hypopnea index, higher baseline self-efficacy, and use of CPAP (≥ 4 h) at 1 week were independent predictors of CPAP adherence at 6 months. CPAP adherence increased by a factor of 1.8 (odds ratio = 1.8, 95% confidence interval 1.1-3.0) for every one-unit increase in self-efficacy. There was no difference between groups postintervention in self-efficacy scores, sleepiness, mood, or sleep quality. In this randomized trial, a single SCT application did not increase adherence when compared with SI time. Although self-efficacy scores prior to CPAP predicted adherence, self-efficacy was not increased by the interventions. Increasing intensity and understanding of SCT interventions may be needed to improve CPAP adherence. Australian New Zealand Clinical Trials Registry, ACTRN12607000424404.
Peets, Adam D; Cooke, Lara; Wright, Bruce; Coderre, Sylvain; McLaughlin, Kevin
Effective teaching requires an understanding of both what (content knowledge) and how (process knowledge) to teach. While previous studies involving medical students have compared preceptors with greater or lesser content knowledge, it is unclear whether process expertise can compensate for deficient content expertise. Therefore, the objective of our study was to compare the effect of preceptors with process expertise to those with content expertise on medical students' learning outcomes in a structured small group environment. One hundred and fifty-one first year medical students were randomized to 11 groups for the small group component of the Cardiovascular-Respiratory course at the University of Calgary. Each group was then block randomized to one of three streams for the entire course: tutoring exclusively by physicians with content expertise (n = 5), tutoring exclusively by physicians with process expertise (n = 3), and tutoring by content experts for 11 sessions and process experts for 10 sessions (n = 3). After each of the 21 small group sessions, students evaluated their preceptors' teaching with a standardized instrument. Students' knowledge acquisition was assessed by an end-of-course multiple choice (EOC-MCQ) examination. Students rated the process experts significantly higher on each of the instrument's 15 items, including the overall rating. Students' mean score (±SD) on the EOC-MCQ exam was 76.1% (8.1) for groups taught by content experts, 78.2% (7.8) for the combination group and 79.5% (9.2) for process expert groups (p = 0.11). By linear regression student performance was higher if they had been taught by process experts (regression coefficient 2.7 [0.1, 5.4], p teach first year medical students within a structured small group environment; preceptors with process expertise result in at least equivalent, if not superior, student outcomes in this setting.
Full Text Available AbstractObjective: Michael’s Game is a card game targeting the ability to generate alternative hypotheses to explain a given experience. The main objective was to evaluate the effect of MG on delusional conviction as measured by the primary study outcome: the change in scores on the conviction subscale of the Peters Delusions Inventory (PDI-21. Other variables of interest were the change in scores on the distress and preoccupation subscales of the PDI-21, the Brief Psychiatric Rating Scale, the Beck Cognitive Insight Scale, and belief flexibility assessed with the Maudsley Assessment of Delusions Schedule. Methods: We performed a parallel, assessor-blinded, randomised controlled superiority trial comparing treatment as usual plus participation in Michael’s Game (MG with treatment as usual plus being on a waiting list (TAU in a sample of adult outpatients with psychotic disorders and persistent positive psychotic symptoms at inclusion. Results: The 172 participants were randomised, with 86 included in each study arm. Assessments were performed at inclusion (T1: baseline, at 3 months (T2: post-treatment, and at 6 months after the second assessment (T3: follow-up. At T2, a positive treatment effect was observed on the primary outcome, the PDI-21 conviction subscale (p=0.005. At T3, a sustained effect was observed for the conviction subscale (p=0.002. Further effects were also observed at T3 on the PDI-21 distress (p=0.002 and preoccupation subscales (p=0.001, as well as on one of the MADS measures of belief flexibility (anything against the belief (p=0.001. Conclusions: The study demonstrated some significant beneficial effect of MG. http://www.controlled-trials.com/ISRCTN37178153/Funding: Swiss National Science Foundation Grant 32003B-121038
Weber, Benedikt; Bachmann, Chantal C; Braun, Ralph; Abraham, Alison G; Serra, Andreas L; Hofbauer, Günther F L
Regular use of sunbed exposure has been reported to increase 25-hydroxyvitamin-D3 [25(OH)D] serum levels. However, the influence of sunbeds compliant with the recent European Union standard EN-60335-2-27 on 25(OH)D serum levels is unknown. We investigated the impact of standard sunbed use compliant with the European Union standard on 25(OH)D serum modulation and well-being. In a randomized controlled study, 25(OH)D serum levels were measured at enrollment, after 1 week, and after completion of the 12-week period of sunbed use with twice weekly exposure and compared with the control group without any sunbed exposure. In the sunbed intervention group (N = 31), a 27% increase of mean 25(OH)D levels was noted 1 week after starting sunbed use (P < .01). However, after 12 weeks, mean 25(OH)D levels had declined and were no longer different from baseline (P = .06). After 12 weeks, 25(OH)D levels did not differ between the intervention and control group (P = .36). Also the 5-item World Health Organization Well-Being Index score did not differ between the sunbed and control groups (P = .19). For ethical reasons recruitment was limited to persons actively seeking sunbed exposure. Standard use of sunbeds compliant with the European Union standard induced a transient increase of 25(OH)D levels, whereas no change in well-being was observed. Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
Wilhelm, Marcel; Winkler, Alexander; Rief, Winfried; Doering, Bettina K
Hypertension is often treated pharmacologically. Since there is evidence that the cardiovascular system is sensitive to placebo mechanisms, our aim was to conduct an effect size analysis of placebo groups in double-blinded randomized controlled parallel-group drug trials using beta-blockers to treat hypertensive patients. A comprehensive literature search via PubMed, PsycINFO, PSYNDEX, PQDT OPEN, OpenGREY, ISI Web of Knowledge, and the WHO International Clinical Trials Registry Platform provided the basis of our meta-analysis. Effect sizes were estimated using a random-effects model based on 23 studies covering a total of 11,067 participants. Main outcomes were systolic blood pressure (sBP) and diastolic blood pressure (dBP). Blood pressure was lowered in placebo groups with significant and robust effect sizes (Hedges' g). The estimates for sBP (-0.27, P < .001) and dBP (-0.49, P < .001) can be interpreted as small to moderate. The placebo response accounted for 34% of the drug response for sBP and 47% of the drug response for dBP. Our moderator analyses indicated that a higher study quality and more study site visits were marginally associated with a higher placebo response. In light of these strong placebo responses, placebo mechanisms need to be considered in order to improve antihypertensive treatment. Copyright © 2016 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.
McQuaid, Fiona; Jones, Christine; Stevens, Zoe; Plumb, Jane; Hughes, Rhona; Bedford, Helen; Voysey, Merryn; Heath, Paul T; Snape, Matthew D
To explore factors influencing the likelihood of antenatal vaccine acceptance of both routine UK antenatal vaccines (influenza and pertussis) and a hypothetical group B Streptococcus (GBS) vaccine in order to improve understanding of how to optimise antenatal immunisation acceptance, both in routine use and clinical trials. An online survey distributed to women of childbearing age in the UK. 1013 women aged 18-44 years in England, Scotland and Wales. Data from an online survey conducted to gauge the attitudes of 1013 women of childbearing age in England, Scotland and Wales to antenatal vaccination against GBS were further analysed to determine the influence of socioeconomic status, parity and age on attitudes to GBS immunisation, using attitudes to influenza and pertussis vaccines as reference immunisations. Factors influencing likelihood of participation in a hypothetical GBS vaccine trial were also assessed. Women with children were more likely to know about each of the 3 conditions surveyed (GBS: 45% vs 26%, pertussis: 79% vs 63%, influenza: 66% vs 54%), to accept vaccination (GBS: 77% vs 65%, pertussis: 79% vs 70%, influenza: 78% vs 68%) and to consider taking part in vaccine trials (37% vs 27% for a hypothetical GBS vaccine tested in 500 pregnant women). For GBS, giving information about the condition significantly increased the number of respondents who reported that they would be likely to receive the vaccine. Health professionals were the most important reported source of information. Increasing awareness about GBS, along with other key strategies, would be required to optimise the uptake of a routine vaccine, with a specific focus on informing women without previous children. More research specifically focusing on acceptability in pregnant women is required and, given the value attached to input from healthcare professionals, this group should be included in future studies. Published by the BMJ Publishing Group Limited. For permission to use (where not
Rigter, Henk; Henderson, Craig; Pelc, Isidore; Tossmann, Peter; Phan, Olivier; Hendriks, Vincent; Schaub, Michael; Rowe, Cindy
textabstractBackground: Noticing a lack of evidence-based programmes for treating adolescents heavily using cannabis in Europe, government representatives from Belgium, France, Germany, The Netherlands, and Switzerland decided to have U.S.-developed multidimensional family therapy (MDFT) tested in their countries in a trans-national trial, called the International Need for Cannabis Treatment (INCANT) study. Methods: INCANT was a 2 (treatment condition) × 5 (time) repeated measures intent-to-t...
van Oosterhout, B.; Krabbendam, L.; de Boer, K.; Ferwerda, J.; van der Helm, M.; Stant, A. D.; van der Gaag, M.
Background. Metacognitive training (MCT) for patients with psychosis is a psychological group intervention that aims to educate patients about common cognitive biases underlying delusion formation and maintenance, and to highlight their negative consequences in daily functioning. Method. In this
Combs, Stephanie A; Diehl, M Dyer; Chrzastowski, Casey; Didrick, Nora; McCoin, Brittany; Mox, Nicholas; Staples, William H; Wayman, Jessica
The purpose of this study was to compare group boxing training to traditional group exercise on function and quality of life in persons with Parkinson disease (PD). A convenience sample of adults with PD (n = 31) were randomly assigned to boxing training or traditional exercise for 24-36 sessions, each lasting 90 minutes, over 12 weeks. Boxing training included: stretching, boxing (e.g. lateral foot work, punching bags), resistance exercises, and aerobic training. Traditional exercise included: stretching, resistance exercises, aerobic training, and balance activities. Participants were tested before and after completion of training on balance, balance confidence, mobility, gait velocity, gait endurance, and quality of life. The traditional exercise group demonstrated significantly greater gains in balance confidence than the boxing group (p exercise for persons with PD will be an important future consideration for rehabilitation professionals.
Kluding, Patricia M; Pasnoor, Mamatha; Singh, Rupali; D'Silva, Linda J; Yoo, Min; Billinger, Sandra A; LeMaster, Joseph W; Dimachkie, Mazen M; Herbelin, Laura; Wright, Douglas E
.... This was a single-group preliminary study. The setting was an academic medical center. Participants were 18 people who were sedentary and had type 2 diabetes and peripheral neuropathy (mean age=58.1 years, SD=5...
Survey of national guidelines, education and training on phlebotomy in 28 European countries: an original report by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PA).
Simundic, Ana-Maria; Cornes, Michael; Grankvist, Kjell; Lippi, Giuseppe; Nybo, Mads; Kovalevskaya, Svjetlana; Sprongl, Ludek; Sumarac, Zorica; Church, Stephen
European questionnaire survey was conducted by the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PA) to assess how phlebotomy is performed in EFLM countries, including differences in personnel, level of education and skills, and to investigate the presence and compliance of national phlebotomy guidelines on this matter. A questionnaire was constructed containing questions elucidating different aspects of the organization behind the phlebotomy praxis on a national basis, including questions on the staff performing phlebotomy, the education of these staff members, and the existence of and adherence to national guidelines. All 39 EFLM member countries were invited to participate. In total 28/39 (72%) EFLM member countries responded. Seven out of the 28 (25%) have national phlebotomy guidelines and five have implemented other guidelines. The estimated compliance with phlebotomy guidance for the laboratories in the countries that have national guidelines available is poor, regardless to whether the phlebotomy was under the laboratory control or not. Most countries were interested in EFLM guidelines and to participate in a pilot EFLM preanalytical phase external quality assessment (EQA) scheme. In the responding EFLM member countries, the majority of phlebotomy is performed by nurses and laboratory technicians. Their basic education is generally 4-5 years of high school, followed by 2-5 years of colleague or university studies. Only a third (10/28; 36%) of the participating member countries has any specific training available as a continuous educational resource. A specific training for phlebotomy is not part of the education required to become qualified in 6/28 (21%) and 9/28 (32%) of countries for nurses and laboratory technicians, respectively. In countries and professions where training is required, most require more than 5 h of training. Based on the results of this survey we conclude the
Francis, P.; Crown, J.; Di, Leo A.
BACKGROUND: Docetaxel is more effective than doxorubicin for patients with advanced breast cancer. The Breast International Group 02-98 randomized trial tested the effect of incorporating docetaxel into anthracycline-based adjuvant chemotherapy and compared sequential vs concurrent administration...... of doxorubicin at 50 mg/m2 plus docetaxel at 75 mg/m2, followed by three cycles of CMF). The primary comparison evaluated the efficacy of including docetaxel regardless of schedule and was planned after 1215 disease-free survival (DFS) events (ie, relapse, second primary cancer, or death from any cause...
Petri, N.; Svanholt, P.; Solow, B.
The aim of this trial was to evaluate the efficacy of a mandibular advancement appliance (MAA) for obstructive sleep apnoea (OSA). Ninety-three patients with OSA and a mean apnoea-hypopnoea index (AHI) of 34.7 were centrally randomised into three, parallel groups: (a) MAA; (b) mandibular non......-advancement appliance (MNA); and (c) no intervention. The appliances were custom made, in one piece. The MAAs had a mean protrusion of the mandible of 74% (range 64-85%). Outcome measures, assessed after continuous use for 4 weeks, were AHI (polysomnography), daytime sleepiness (Epworth) and quality of life (SF-36...
Timmerman, Robert; Galvin, James; Michalski, Jeff; Straube, William; Ibbott, Geoffrey; Martin, Elizabeth; Abdulrahman, Ramzi; Swann, Suzanne; Fowler, Jack; Choy, Hak
Starting in 2002, the Radiation Therapy Oncology Group in North America began the process of developing multicenter prospective trials in lung cancer using Stereotactic Body Radiation Therapy (SBRT). Much of the work was based on the prospective single institution trials from Indiana University that had been presented and published. In late 2004, RTOG 0236 using SBRT for medically inoperable patients with clinical stage I non-small cell lung cancer (NSCLC) was activated for accrual. Prior to activation, representatives from the Lung, Image-Guided Therapy, Physics, and Radiobiology Committees met on regular occasions to design the multicenter study and quality assurance measures. SBRT is not a black box, and the essence of the therapy had to be distilled via guidelines. Issues related to patient selection, method of dosimetry construction, equipment requirements, motion assessments and control, site accreditation, data exchange, and follow-up policies were worked out by compromise and consensus. RTOG 0236 has nearly completed its accrual. The Lung Committee has initiated the development of several other trials, each building on the last, to investigate the therapy in central tumors, in combinations with systemic therapy, in operable patients, and in lung metastases patients. The guidelines developed for RTOG 0236 will be refined to take advantage of more modern innovations including heterogeneity corrections and intensity modulation when appropriate. The development of RTOG 0618 using SBRT in operable patients with early stage NSCLC is a testament to both the enthusiasm from already published works and prospective multicenter clinical testing using SBRT techniques.
Stöck, Matthias; Dufresnes, Christophe; Litvinchuk, Spartak N; Lymberakis, Petros; Biollay, Sébastien; Berroneau, Matthieu; Borzée, Amaël; Ghali, Karim; Ogielska, Maria; Perrin, Nicolas
We characterize divergence times, intraspecific diversity and distributions for recently recognized lineages within the Hyla arborea species group, based on mitochondrial and nuclear sequences from 160 localities spanning its whole distribution. Lineages of H. arborea, H. orientalis, H. molleri have at least Pliocene age, supporting species level divergence. The genetically uniform Iberian H. molleri, although largely isolated by the Pyrenees, is parapatric to H. arborea, with evidence for successful hybridization in a small Aquitanian corridor (southwestern France), where the distribution also overlaps with H. meridionalis. The genetically uniform H. arborea, spread from Crete to Brittany, exhibits molecular signatures of a postglacial range expansion. It meets different mtDNA clades of H. orientalis in NE-Greece, along the Carpathians, and in Poland along the Vistula River (there including hybridization). The East-European H. orientalis is strongly structured genetically. Five geographic mitochondrial clades are recognized, with a molecular signature of postglacial range expansions for the clade that reached the most northern latitudes. Hybridization with H. savignyi is suggested in southwestern Turkey. Thus, cryptic diversity in these Pliocene Hyla lineages covers three extremes: a genetically poor, quasi-Iberian endemic (H. molleri), a more uniform species distributed from the Balkans to Western Europe (H. arborea), and a well-structured Asia Minor-Eastern European species (H. orientalis). Copyright © 2012 Elsevier Inc. All rights reserved.
Guo, Mingchun; Morawska, Alina; Sanders, Matthew R
This study evaluated the effects of Group Triple P with Chinese parents on parenting and child outcomes as well as outcomes relating to child academic learning in Mainland China. Participants were 81 Chinese parents and their children in Shanghai, who were randomly allocated to an intervention group or wait-list control group. Parents in the intervention condition received Group Triple P training, and parents and children were assessed at three/two time points. Compared with the control group, parents in the intervention group reported significant improvements in child adjustment problems, parenting practices, parental adjustment, and parenting self-efficacy at post-assessment. Moreover, there was a significant increase in parents' satisfaction with children's academic achievement and a reduction in children's academic problem behaviors at post-intervention. All these effects were maintained at 6-month follow-up. There was also a significant increase in the child report of positive parenting at post-intervention. © The Author(s) 2016.
Boessen, Ruud; van der Baan, Frederieke; Groenwold, Rolf; Egberts, Antoine; Klungel, Olaf; Grobbee, Diederick; Knol, Mirjam; Roes, Kit
Two-stage clinical trial designs may be efficient in pharmacogenetics research when there is some but inconclusive evidence of effect modification by a genomic marker. Two-stage designs allow to stop early for efficacy or futility and can offer the additional opportunity to enrich the study population to a specific patient subgroup after an interim analysis. This study compared sample size requirements for fixed parallel group, group sequential, and adaptive selection designs with equal overall power and control of the family-wise type I error rate. The designs were evaluated across scenarios that defined the effect sizes in the marker positive and marker negative subgroups and the prevalence of marker positive patients in the overall study population. Effect sizes were chosen to reflect realistic planning scenarios, where at least some effect is present in the marker negative subgroup. In addition, scenarios were considered in which the assumed 'true' subgroup effects (i.e., the postulated effects) differed from those hypothesized at the planning stage. As expected, both two-stage designs generally required fewer patients than a fixed parallel group design, and the advantage increased as the difference between subgroups increased. The adaptive selection design added little further reduction in sample size, as compared with the group sequential design, when the postulated effect sizes were equal to those hypothesized at the planning stage. However, when the postulated effects deviated strongly in favor of enrichment, the comparative advantage of the adaptive selection design increased, which precisely reflects the adaptive nature of the design. Copyright © 2013 John Wiley & Sons, Ltd.
Simkiss, Douglas E; Snooks, Helen A; Stallard, Nigel; Davies, Shan; Thomas, Marie A; Anthony, Becky; Winstanley, Sarah; Wilson, Lynsey; Stewart-Brown, Sarah
Sub-optimal parenting is a common risk factor for a wide range of negative health, social and educational outcomes. Most parenting programmes have been developed in the USA in the context of delinquency prevention for targeted or indicated groups and the main theoretical underpinning for these programmes is behaviour management. The Family Links Nurturing Programme (FLNP) focuses on family relationships as well as behaviour management and is offered on a universal basis. As a result it may be better placed to improve health and educational outcomes. Developed in the UK voluntary sector, FLNP is popular with practitioners, has impressed policy makers throughout the UK, has been found to be effective in before/after and qualitative studies, but lacks a randomised controlled trial (RCT) evidence base. A multi-centre, investigator blind, randomised controlled trial of the FLNP with a target sample of 288 south Wales families who have a child aged 2-4 yrs living in or near to Flying Start/Sure Start areas. Changes in parenting, parent child relations and parent and child wellbeing are assessed with validated measures immediately and at 6 months post intervention. Economic components include cost consequences and cost utility analyses based on parental ranking of states of quality of life. Attendance and completion rates and fidelity to the FLNP course delivery are assessed. A nested qualitative study will assess reasons for participation and non-participation and the perceived value of the programme to families. By the end of May 2010, 287 families have been recruited into the trial across four areas of south Wales. Recruitment has not met the planned timescales with barriers including professional anxiety about families entering the control arm of the trial, family concern about video and audio recording, programme facilitator concern about the recording of FLNP sessions for fidelity purposes and delays due to the new UK research governance procedures. Whilst there are
Azkhosh, Manoochehr; Farhoudianm, Ali; Saadati, Hemn; Shoaee, Fateme; Lashani, Leila
Objective: Substance abuse is a socio-psychological disorder. The aim of this study was to compare the effectiveness of acceptance and commitment therapy with 12-steps Narcotics Anonymous on psychological well-being of opiate dependent individuals in addiction treatment centers in Shiraz, Iran. Method: This was a randomized controlled trial. Data were collected at entry into the study and at post-test and follow-up visits. The participants were selected from opiate addicted individuals who referred to addiction treatment centers in Shiraz. Sixty individuals were evaluated according to inclusion/ exclusion criteria and were divided into three equal groups randomly (20 participants per group). One group received acceptance and commitment group therapy (Twelve 90-minute sessions) and the other group was provided with the 12-steps Narcotics Anonymous program and the control group received the usual methadone maintenance treatment. During the treatment process, seven participants dropped out. Data were collected using the psychological well-being questionnaire and AAQ questionnaire in the three groups at pre-test, post-test and follow-up visits. Data were analyzed using repeated measure analysis of variance. Results: Repeated measure analysis of variance revealed that the mean difference between the three groups was significant (Pacceptance and commitment therapy group showed improvement relative to the NA and control groups on psychological well-being and psychological flexibility. Conclusion: The results of this study revealed that acceptance and commitment therapy can be helpful in enhancing positive emotions and increasing psychological well-being of addicts who seek treatment.
Classical swine fever virus detection: results of a real-time reverse transcription polymerase chain reaction ring trial conducted in the framework of the European network of excellence for epizootic disease diagnosis and control.
Hoffmann, B.; Blome, S.; Bonulauri, P.; Fernández-Pinero, J.; Greiser-Wilke, I.; Haegeman, A.; Isaksson, M.; Koenen, F.; Leblanc, N.; Leifer, I.; Potier, Le M.F.; Loeffen, W.; Rasmussen, T.B.; Stadejek, T.; Stahl, K.; Tignon, M.; Uttenthal, A.; Poel, van der W.H.M.
The current study reports on a real-time reverse transcription polymerase chain reaction (real-time RT-PCR) ring trial for the detection of Classical swine fever virus (CSFV) genomic RNA undertaken by 10 European laboratories. All laboratories were asked to use their routine in-house real-time
Full Text Available Tuberculosis (TB today remains a global emergency affecting 9.0 million people globally. The African Region bears the highest global TB/HIV burden and over 50% of TB cases in SSA are co-infected with HIV. An estimated 1.5 million died from the TB globally in 2013. A large majority of the 360,000 HIV-positive TB cases who died were from sub-Saharan Africa. Research and development is an important pillar of the WHO post-2015 global TB strategy. Advances in development of diagnostics, drugs, host-directed therapies, and vaccines will require evaluation under field conditions through multi-centre clinical trials at different geographical locations. Thus it is critically important that these evaluations are fully supported by all African governments and the capacity, trained staff and infrastructure required to perform the research and evaluations is built and made available. This viewpoint article reviews the opportunities provided by recently launched second programme (2015-2024 of the European & Developing Countries Clinical Trials Partnership (EDCTP2 for tackling the TB epidemic in Africa through its magnanimous portfolio. The unique opportunities provided by EDCTP2 for leadership of scientific research in TB and other diseases fully devolving to Africa are also covered.
Rodenburg, T.B.; Berk, J; Dimitrov, I.
by the three working groups: 1) Genetics and damaging behaviour, 2) Effects of development on damaging behaviour, and 3) Relationships between health and damaging behaviour. For the work on genetics, we focus on developing new techniques to measure relevant phenotypes (e.g. sensor technology) and investigate...... methods to link these sensor data to genomic data. Regarding development, the network will review the effects of parental conditions on offspring behaviour. Further, the role of incubation conditions (light, noise, temperature) and early-life environment in the development of damaging behaviour...... and brain. Taken together, the network aims to provide new knowledge that can be applied to further develop production systems where laying hens with intact beaks can be optimally managed and damaging behaviour can be controlled....
Full Text Available Abstract Background BRCA mutation carriers have a 40-80% life-time risk of developing breast cancer. They may opt for yearly breast cancer surveillance or for prophylactic mastectomy. Both options show increased survival rates. It is a complex choice to be made between these two options. As a result most women experience high levels of distress and high needs for information. To fulfill the needs for psychosocial support and information we have introduced group medical consultations (GMCs. A GMC provides individual medical visits conducted within a group. This 90 minute group-visit with 8-12 patients gives patients the opportunity to spend more time with their clinician and a behavioral health professional and learn from other patients experiencing similar topics. However, it should be noted that group sessions may increase fear in some patients or influence their decision making. Methods/design In this randomized controlled trial, 160 BRCA mutation carriers diagnosed maximally 2 years ago are recruited from the Radboud University Nijmegen Medical Centre. Participants are randomized in a 1:1 ratio to either the GMC intervention group (onetime participation in a GMC instead of a standard individual visit or to a usual care control group. Primary outcome measures are empowerment and psychological distress (SCL 90. Secondary outcome measures are fear of cancer, information needs before the consultation and the received information, self-examination of the breasts, patient satisfaction, quality of life and cost-effectiveness. Data are collected via self-reported questionnaires 1 week before the visit, and at 1 week and at 3 months follow-up. A pilot study was conducted to test all procedures and questionnaires. Discussion The possibility for interaction with other BRCA mutation carriers within a medical visit is unique. This study will assess the effectiveness of GMCs for BRCA mutation carriers to improve empowerment and decrease distress compared
Gerke, Oke; Vilstrup, Mie H; Halekoh, Ulrich; Hildebrandt, Malene Grubbe; Høilund-Carlsen, Poul Flemming
Group-sequential testing is widely used in pivotal therapeutic, but rarely in diagnostic research, although it may save studies, time, and costs. The purpose of this paper was to demonstrate a group-sequential analysis strategy in an intra-observer study on quantitative FDG-PET/CT measurements, illuminating the possibility of early trial termination which implicates significant potential time and resource savings. Primary lesion maximum standardised uptake value (SUVmax) was determined twice from preoperative FDG-PET/CTs in 45 ovarian cancer patients. Differences in SUVmax were assumed to be normally distributed, and sequential one-sided hypothesis tests on the population standard deviation of the differences against a hypothesised value of 1.5 were performed, employing an alpha spending function. The fixed-sample analysis (N = 45) was compared with the group-sequential analysis strategies comprising one (at N = 23), two (at N = 15, 30), or three interim analyses (at N = 11, 23, 34), respectively, which were defined post hoc. When performing interim analyses with one third and two thirds of patients, sufficient agreement could be concluded after the first interim analysis and the final analysis. Other partitions did not suggest early stopping after adjustment for multiple testing due to one influential outlier and our small sample size. Group-sequential testing may enable early stopping of a trial, allowing for potential time and resource savings. The testing strategy must, though, be defined at the planning stage, and sample sizes must be reasonably large at interim analysis to ensure robustness against single outliers. Group-sequential testing may have a place in accuracy and agreement studies.
Linde Jennifer A
Full Text Available Abstract Background U.S. adults are at unprecedented risk of becoming overweight or obese, and most scientists believe the primary cause is an obesogenic environment. Worksites provide an opportunity to shape the environments of adults to reduce obesity risk. The goal of this group-randomized trial was to implement a four-component environmental intervention at the worksite level to positively influence weight gain among employees over a two-year period. Environmental components focused on food availability and price, physical activity promotion, scale access, and media enhancements. Methods Six worksites in a U.S. metropolitan area were recruited and randomized in pairs at the worksite level to either a two-year intervention or a no-contact control. Evaluations at baseline and two years included: 1 measured height and weight; 2 online surveys of individual dietary intake and physical activity behaviors; and 3 detailed worksite environment assessment. Results Mean participant age was 42.9 years (range 18-75, 62.6% were women, 68.5% were married or cohabiting, 88.6% were white, 2.1% Hispanic. Mean baseline BMI was 28.5 kg/m2 (range 16.9-61.2 kg/m2. A majority of intervention components were successfully implemented. However, there were no differences between sites in the key outcome of weight change over the two-year study period (p = .36. Conclusions Body mass was not significantly affected by environmental changes implemented for the trial. Results raise questions about whether environmental change at worksites is sufficient for population weight gain prevention. Trial Registration ClinicalTrials.gov: NCT00708461
Pinxsterhuis, Irma; Sandvik, Leiv; Strand, Elin Bolle; Bautz-Holter, Erik; Sveen, Unni
To evaluate the effectiveness of a group-based self-management program for people with chronic fatigue syndrome. A randomized controlled trial. Four mid-sized towns in southern Norway and two suburbs of Oslo. A total of 137 adults with chronic fatigue syndrome. A self-management program including eight biweekly meetings of 2.5 hours duration. The control group received usual care. Primary outcome measure: Medical Outcomes Study-Short Form-36 physical functioning subscale. Fatigue severity scale, self-efficacy scale, physical and mental component summary of the Short Form-36, and the illness cognition questionnaire (acceptance subscale). Assessments were performed at baseline, and at six-month and one-year follow-ups. At the six-month follow-up, a significant difference between the two groups was found concerning fatigue severity ( p = 0.039) in favor of the control group, and concerning self-efficacy in favor of the intervention group ( p = 0.039). These significant differences were not sustained at the one-year follow-up. No significant differences were found between the groups concerning physical functioning, acceptance, and health status at any of the measure points. The drop-out rate was 13.9% and the median number of sessions attended was seven (out of eight). The evaluated self-management program did not have any sustained effect, as compared with receiving usual care.
Laramore, G. E. [Washington U.; Krall, J. M. [Unlisted, US, PA; Thomas, F. J. [Unlisted, US, OH; Russell, K. J. [Washington U.; Maor, M. H. [Unlisted, US, TX; Hendrickson, F. R. [Fermilab; Martz, K. L. [Unlisted, US, PA; Griffin, T. W. [Washington U.
Between June 1977 and April 1983 the Radiation Therapy Oncology Group (RTOG) sponsored a Phase III randomized trial investigating the use of fast neutron radiotherapy for patients with locally advanced (Stages C and D1) adenocarcinoma of the prostate gland. Patients were randomized to receive either conventional photon radiation or fast neutron radiation used in a mixed-beam (neutron/photon) treatment schedule. A total of 91 analyzable patients were entered into the study, and the two patient groups were balanced with respect to the major prognostic variables. Actuarial curves are presented for local/regional control and "overall" survival. Ten-year results for clinically assessed local control are 70% for the mixed-beam group versus 58% for the photon group (p = 0.03) and for survival are 46% for the mixed-beam group versus 29% for the photon group (p = 0.04). This study suggests that a regional method of treatment can influence both local tumor control and survival in patients with locally advanced adenocarcinoma of the prostate gland.
Wong, Samuel Yeung Shan; Yip, Benjamin Hon Kei; Mak, Winnie Wing Sze; Mercer, Stewart; Cheung, Eliza Yee Lai; Ling, Candy Yuet Man; Lui, Wacy Wai Sze; Tang, Wai Kwong; Lo, Herman Hay Ming; Wu, Justin Che Yuen; Lee, Tatia Mei Chun; Gao, Ting; Griffiths, Sian M; Chan, Peter Hoi Sing; Ma, Helen Shuk Wah
Research suggests that an 8-week mindfulness-based cognitive therapy (MBCT) course may be effective for generalised anxiety disorder (GAD). To compare changes in anxiety levels among participants with GAD randomly assigned to MBCT, cognitive-behavioural therapy-based psychoeducation and usual care. In total, 182 participants with GAD were recruited (trial registration number: CUHK_CCT00267) and assigned to the three groups and followed for 5 months after baseline assessment with the two intervention groups followed for an additional 6 months. Primary outcomes were anxiety and worry levels. Linear mixed models demonstrated significant group × time interaction (F(4,148) = 5.10, P = 0.001) effects for decreased anxiety for both the intervention groups relative to usual care. Significant group × time interaction effects were observed for worry and depressive symptoms and mental health-related quality of life for the psychoeducation group only. These results suggest that both of the interventions appear to be superior to usual care for the reduction of anxiety symptoms. © The Royal College of Psychiatrists 2016.
Edgar, L; Rosberger, Z; Collet, J P
Nucare, a short-term psychoeducational coping skills training intervention was evaluated in a randomized controlled clinical trial (RCT) of 225 newly diagnosed breast and colon cancer patients. Measures of psychosocial distress, well being and optimism were evaluated every four months during a one-year period. Patients were randomized to one of four arms: Nucare presented in an individual basis; Nucare presented in a group format; a non-directive supportive group; and a no-intervention control. The interventions were provided in five sessions of ninety minutes each. Patients with breast cancer who received Nucare presented in an individual format showed more significant improvements in well-being over time compared to those in the control and group arms. We were unable to develop functioning groups within the RCT. Partial explanations for the latter finding include the structural limitations of the RCT: the groups were small, difficult to schedule and patients indicated that they would have preferred to choose whether or not to participate in a group. The positive changes in women with breast cancer who received Nucare persisted at 12 months.
Intima media thickness measurement in children: A statement from the Association for European Paediatric Cardiology (AEPC) Working Group on Cardiovascular Prevention endorsed by the Association for European Paediatric Cardiology.
Dalla Pozza, Robert; Ehringer-Schetitska, Doris; Fritsch, Peter; Jokinen, Eero; Petropoulos, Andreas; Oberhoffer, Renate
Atherosclerosis causing cardiovascular disease is the most common cause of death in the developed world. Early precursors of vascular changes - subclinical atherosclerosis - warrant special attention as this process can be stabilized or even reversed if treated in time. Sonographic Intima Media Thickness measurement of the carotid artery (cIMT: carotid Intima-Media-Thickness) is considered a valid surrogate marker for cardiovascular risk allowing assessment of atherosclerotic changes at a very early stage. It is easy to apply due to its non-invasive character. Moreover, cIMT has been proven to provide reliable and reproducible results both in adult and adolescent patients. For the paediatric age group, several characteristics deserve special consideration. The heterogeneity of techniques of scanning, measurement and interpretation impede the comparison and interpretation of IMT values so far. Also, age- and sex-dependent normative data have to be considered for interpretation. Thus, the Association for European Paediatric Cardiology (AEPC) Working Group on Cardiovascular Prevention concludes to refer a statement on cIMT scanning, measurement and interpretation with special focus on paediatric patients. This statement includes an overview on normative data available as well as a practical guideline for the setting, scanning, measurement and interpretation of IMT values. Synchronizing different measurement methods will allow for comparing the results of several research centers. By that, in a large patient number, sufficient information may be given to assess the long-term endpoints of cardiovascular morbidity and mortality. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
Kjøbli, John; Hukkelberg, Silje; Ogden, Terje
Group-based Parent Management Training, the Oregon model (PMTO, 12 sessions) was delivered by the regular staff of municipal child and family services. PMTO is based on social interaction learning theory and promotes positive parenting skills in parents of children with conduct problems. This study examined the effectiveness of the group-based training intervention in real world settings both immediately following and six months after termination of the intervention. One hundred thirty-seven children (3-12 years) and their parents participated in this study. The families were randomly assigned to group-based training or a comparison group. Data were collected from parents and teachers. The caregiver assessments of parenting practices and child conduct problems and caregiver and teacher reported social competence revealed immediate and significant intervention effects. Short- and long-term beneficial effects were reported from parents, although no follow-up effects were evident on teacher reports. These effectiveness findings and the potential for increasing the number of families served to support the further dissemination and implementation of group-based parent training. Copyright © 2012 Elsevier Ltd. All rights reserved.
Kamat, A.M.; Sylvester, R.J.; Bohle, A.; Palou, J.; Lamm, D.L.; Brausi, M.; Soloway, M.; Persad, R.; Buckley, R.; Colombel, M.; Witjes, J.A.
PURPOSE: To provide recommendations on appropriate clinical trial designs in non-muscle-invasive bladder cancer (NMIBC) based on current literature and expert consensus of the International Bladder Cancer Group. METHODS: We reviewed published trials, guidelines, meta-analyses, and reviews and
Kress, H.G.; Laage, D. Von der; Hoerauf, K.H.
to be pharmacokinetically bioequivalent to the marked fentanyl patch. To determine noninferiority in efficacy in cancer patients and to compare safety, a clinical trial comparing the new fentanyl patch with standard oral or transdermal opioid treatment was planned. The design was an open, parallel group, multicenter trial...
Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group
Pradhan, M.; Brinkman, S.A.; Beatty, A.; Maika, A.; Satriawan, E.; de Ree, J.; Hasan, A.
Background This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program
Van Gerwen, Lucas J; Spinhoven, Philip; Van Dyck, Richard
In a long-standing fear-of-flying program, persons with fear of flying (N=150) were after a diagnostic assessment and individual preparation phase randomly assigned to either a 1-day behavioral group treatment (BGT) program, a 2-day cognitive-behavioral group treatment (CBGT) program or a waiting list (WL) control group. A post-treatment flight on a commercial airline measured participants' ability to fly. Different self-report flight anxiety questionnaires were completed before, during and after treatment at 3-, 6- and 12-month follow-up. Results indicated that both treatments were superior to the WL, and equally effective on the flying test and later independent flying, but also that the 2-day CBGT program was significantly more effective than the 1-day BGT program on subjective measures of fear and self-efficacy.
King, Laurie A; Wilhelm, Jennifer; Chen, Yiyi; Blehm, Ron; Nutt, John; Chen, Zunqiu; Serdar, Andrea; Horak, Fay B
Comparative studies of exercise interventions for people with Parkinson disease (PD) rarely considered how one should deliver the intervention. The objective of this study was to compare the success of exercise when administered by (1) home exercise program, (2) individualized physical therapy, or (3) a group class. We examined if common comorbidities associated with PD impacted success of each intervention. Fifty-eight people (age = 63.9 ± 8 years) with PD participated. People were randomized into (1) home exercise program, (2) individual physical therapy, or (3) group class intervention. All arms were standardized and based on the Agility Boot Camp exercise program for PD, 3 times per week for 4 weeks. The primary outcome measure was the 7-item Physical Performance Test. Other measures of balance, gait, mobility, quality of life, balance confidence, depressions, apathy, self-efficacy and UPDRS-Motor, and activity of daily living scores were included. Only the individual group significantly improved in the Physical Performance Test. The individual exercise showed the most improvements in functional and balance measures, whereas the group class showed the most improvements in gait. The home exercise program improved the least across all outcomes. Several factors effected success, particularly for the home group. An unsupervised, home exercise program is the least effective way to deliver exercise to people with PD, and individual and group exercises have differing benefits. Furthermore, people with PD who also have other comorbidities did better in a program directly supervised by a physical therapist.Video Abstract available for additional insights from the authors (see Video, Supplemental Digital Content 1, http://links.lww.com/JNPT/A112).
Tonetti, Maurizio S; Jepsen, Søren
The scope of the discussions of this consensus report was to assess the strength of the scientific evidence and make clinical and research recommendations for surgical interventions to cover exposed root surfaces and enhance soft tissues at implants. Discussions were informed by three systematic reviews covering single recessions, multiple recessions and soft-tissue deficiencies at implants. The strength of the evidence was assessed using a modification in GRADE. The group also emphasized the need to report the experience of the surgeon and the performance of the control intervention (CONSORT guidelines for non-pharmacological treatment). A moderate strength of evidence supported the following statements for single (moderately deep, mostly maxillary) recessions without inter-dental attachment loss: (i) The addition of a connective tissue graft (CTG) improved outcomes of coronally advanced flaps (CAF). (ii) The addition of enamel matrix derivative (EMD) improved the outcomes of CAF. For multiple recessions, preliminary data indicate that flaps specifically designed to treat this condition are worthy of additional attention. Emerging data indicate that it is possible to obtain complete root coverage at sites with some inter-dental attachment loss. With regards to soft-tissue deficiencies at implants, several procedures are available, but great heterogeneity among studies does not allow drawing conclusions at this time. The group highlighted that periodontal plastic procedures are complex, technique-sensitive interventions that require advanced skills and expertise. At single recessions, the addition of autologous CTG or EMD under CAF improves complete root coverage and may be considered the procedure of choice at maxillary anterior and premolar teeth. The adjunctive benefit needs to be put in the context of increased morbidity of the donor area or increased cost. Additional research is needed to: (i) assess the role of alternatives to autologous soft-tissue grafting
Klek, Stanislaw; Forbes, Alastair; Gabe, Simon; Holst, Mette; Wanten, Geert; Irtun, Øivind; Damink, Steven Olde; Panisic-Sekeljic, Marina; Pelaez, Rosa Burgos; Pironi, Loris; Blaser, Annika Reintam; Rasmussen, Henrik Højgaard; Schneider, Stéphane M; Thibault, Ronan; Visschers, Ruben G J; Shaffer, Jonathan
Intestinal failure (IF) is the consequence of a reduction of gut function below the minimum necessary for the absorption of nutrients from the gastrointestinal tract. Types I and II comprise acute intestinal failure (AIF). Although its prevalence is relatively low, type II AIF is serious and requires specialist multidisciplinary care, often for prolonged periods before its resolution. The key aspects are: sepsis control, fluid and electrolyte resuscitation, optimization of nutritional status, wound care, appropriate surgery and active rehabilitation. The ESPEN Acute Intestinal Failure Special Interest Group (AIF SIG) has devised this position paper to provide a state-of-the-art overview of the management of type II AIF and to point out areas for future research. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.
Fiks, Alexander G; Gruver, Rachel S; Bishop-Gilyard, Chanelle T; Shults, Justine; Virudachalam, Senbagam; Suh, Andrew W; Gerdes, Marsha; Kalra, Gurpreet K; DeRusso, Patricia A; Lieberman, Alexandra; Weng, Daniel; Elovitz, Michal A; Berkowitz, Robert I; Power, Thomas J
Few studies have addressed obesity prevention among low-income families whose infants are at increased obesity risk. We tested a Facebook peer-group intervention for low-income mothers to foster behaviors promoting healthy infant growth. In this randomized controlled trial, 87 pregnant women (Medicaid insured, BMI ≥25 kg/m2) were randomized to the Grow2Gether intervention or text message appointment reminders. Grow2Gether participants joined a private Facebook group of 9-13 women from 2 months before delivery until infant age 9 months. A psychologist facilitated groups featuring a curriculum of weekly videos addressing feeding, sleep, parenting, and maternal well-being. Feasibility was assessed using the frequency and content of participation, and acceptability using surveys. Maternal beliefs and behaviors and infant growth were assessed at birth, 2, 4, 6, and 9 months. Differences in infant growth between study arms were explored. We conducted intention-to-treat analyses using quasi-least-squares regression. Eighty-eight percent (75/85) of intervention participants (42% (36/85) food insecure, 88% (75/85) black) reported the group was helpful. Participants posted 30 times/group/week on average. At 9 months, the intervention group had significant improvement in feeding behaviors (Infant Feeding Style Questionnaire) compared to the control group (p = 0.01, effect size = 0.45). Intervention group mothers were significantly less likely to pressure infants to finish food and, at age 6 months, give cereal in the bottle. Differences were not observed for other outcomes, including maternal feeding beliefs or infant weight-for-length. A social media peer-group intervention was engaging and significantly impacted certain feeding behaviors in families with infants at high risk of obesity.
Dorris, Liam; Broome, Helen; Wilson, Margaret; Grant, Cathy; Young, David; Baker, Gus; Balloo, Selina; Bruce, Susan; Campbell, Jo; Concannon, Bernie; Conway, Nadia; Cook, Lisa; Davis, Cheryl; Downey, Bruce; Evans, Jon; Flower, Diane; Garlovsky, Jack; Kearney, Shauna; Lewis, Susan; Stephens, Victoria; Turton, Stuart; Wright, Ingram
We conducted an exploratory RCT to examine feasibility and preliminary efficacy for a manual-based psychosocial group intervention aimed at improving epilepsy knowledge, self-management skills, and quality of life in young people with epilepsy. Eighty-three participants (33:50m/f; age range 12-17years) were randomized to either the treatment or control group in seven tertiary paediatric neuroscience centres in the UK, using a wait-list control design. Participants were excluded if they reported suicidal ideation and/or scored above the cut off on mental health screening measures, or if they had a learning disability or other neurological disorder. The intervention consisted of six weekly 2-hour sessions using guided discussion, group exercises and role-plays facilitated by an epilepsy nurse and a clinical psychologist. At three month follow up the treatment group (n=40) was compared with a wait-list control group (n=43) on a range of standardized measures. There was a significant increase in epilepsy knowledge in the treatment group (p=0.02). Participants receiving the intervention were also significantly more confident in speaking to others about their epilepsy (p=0.04). Quality of life measures did not show significant change. Participants reported the greatest value of attending the group was: Learning about their epilepsy (46%); Learning to cope with difficult feelings (29%); and Meeting others with epilepsy (22%). Caregiver and facilitator feedback was positive, and 92% of participants would recommend the group to others. This brief psychosocial group intervention was effective in increasing participants' knowledge of epilepsy and improved confidence in discussing their epilepsy with others. We discuss the qualitative feedback, feasibility, strengths and limitations of the PIE trial. Copyright © 2017 Elsevier Inc. All rights reserved.
Lazarov, Amit; Marom, Sofi; Yahalom, Naomi; Pine, Daniel S; Hermesh, Haggai; Bar-Haim, Yair
Cognitive-behavioral group therapy (CBGT) is a first-line treatment for social anxiety disorder (SAD). However, since many patients remain symptomatic post-treatment, there is a need for augmenting procedures. This randomized controlled trial (RCT) examined the potential augmentation effect of attention bias modification (ABM) for CBGT. Fifty patients with SAD from three therapy groups were randomized to receive an 18-week standard CBGT with either ABM designed to shift attention away from threat (CBGT + ABM), or a placebo protocol not designed to modify threat-related attention (CBGT + placebo). Therapy groups took place in a large mental health center. Clinician and self-report measures of social anxiety and depression were acquired pre-treatment, post-treatment, and at 3-month follow-up. Attention bias was assessed at pre- and post-treatment. Patients randomized to the CBGT + ABM group, relative to those randomized to the CBGT + placebo group, showed greater reductions in clinician-rated SAD symptoms post-treatment, with effects maintained at 3-month follow-up. Group differences were not evident for self-report or attention-bias measures, with similar reductions in both groups. Finally, reduction in attention bias did not mediate the association between group and reduction in Liebowitz Social Anxiety Scale Structured Interview (LSAS) scores. This is the first RCT to examine the possible augmenting effect of ABM added to group-based cognitive-behavioral therapy for adult SAD. Training patients' attention away from threat might augment the treatment response to standard CBGT in SAD, a possibility that could be further evaluated in large-scale RCTs.
Full Text Available Abstract Background Little is known about the effectiveness of Housing First (HF among ethnic minority groups, despite its growing popularity for homeless adults experiencing mental illness. This randomized controlled trial tests the effectiveness of a HF program using rent supplements and intensive case management, enhanced by anti-racism and anti-oppression practices for homeless adults with mental illness from diverse ethnic minority backgrounds. Methods This unblinded pragmatic field trial was carried out in community settings in Toronto, Canada. Participants were 237 adults from ethnic minority groups experiencing mental illness and homelessness, who met study criteria for moderate needs for mental health services. Participants were randomized to either adapted HF (n = 135 or usual care (n = 102 and followed every 3 months for 24 months. The primary study outcome was housing stability; secondary outcomes included physical and mental health, social functioning, quality of life, arrests and health service use. Intention to treat statistical analyses examined the effectiveness of the intervention compared to usual care. Results During the 24-month study period, HF participants were stably housed a significantly greater proportion of time compared to usual care participants, 75 % (95 % CI 70 to 81 vs. 41 % (95 % CI 35 to 48, respectively, for a difference of 34 %, 95 % CI 25 to 43. HF also led to improvements in community integration over the course of the study: the change in the mean difference between treatment groups from baseline to 24-months was significantly greater among HF participants compared to those in usual care (change in mean difference = 2.2, 95 % CI 0.06 to 4.3. Baseline diagnosis of psychosis was associated with reduced likelihood of being housed ≥ 50 % of the study period (OR = 0.37, 95 % CI 0.18 to 0.72. Conclusion Housing First enhanced with anti-racism and anti-oppression practices can
Turner, Lucy; Foster, Garth N.
The Hydroporus memnonius species group includes both widespread and range restricted diving beetle taxa in the western Palaearctic, some of which have been divided into a number of geographical subspecies. Of these, Hydroporus necopinatus is distributed in the far west of Europe, from central Spain to southern Britain, and has been split into three subspecies, occurring in Iberia (necopinatus sst.), France (robertorum) and England (roni) respectively—the last of these being a rare example of an insect taxon apparently endemic to northern Europe. Here we explore inter-relationships between populations and subspecies of H. necopinatus and related members of the Hydroporus melanarius subgroup, using mitochondrial COI sequence data. We reveal widespread discordance between mitochondrial DNA sequence variation and morphology in areas where H. necopinatus and H. melanarius come into contact, consistent with historical introgressive hybridization between these taxa. In light of this discordance, the lack of clear genetic divergence between H. necopinatus subspecies, and the fact that both robertorum and roni are morphologically intermediate between H. necopinatus sstr. and H. melanarius, we suggest that these taxa may be of hybridogenic origin, rather than representing discrete evolutionary lineages. PMID:28289570
David T. Bilton
Full Text Available The Hydroporus memnonius species group includes both widespread and range restricted diving beetle taxa in the western Palaearctic, some of which have been divided into a number of geographical subspecies. Of these, Hydroporus necopinatus is distributed in the far west of Europe, from central Spain to southern Britain, and has been split into three subspecies, occurring in Iberia (necopinatus sst., France (robertorum and England (roni respectively—the last of these being a rare example of an insect taxon apparently endemic to northern Europe. Here we explore inter-relationships between populations and subspecies of H. necopinatus and related members of the Hydroporus melanarius subgroup, using mitochondrial COI sequence data. We reveal widespread discordance between mitochondrial DNA sequence variation and morphology in areas where H. necopinatus and H. melanarius come into contact, consistent with historical introgressive hybridization between these taxa. In light of this discordance, the lack of clear genetic divergence between H. necopinatus subspecies, and the fact that both robertorum and roni are morphologically intermediate between H. necopinatus sstr. and H. melanarius, we suggest that these taxa may be of hybridogenic origin, rather than representing discrete evolutionary lineages.
Bilton, David T; Turner, Lucy; Foster, Garth N
The Hydroporus memnonius species group includes both widespread and range restricted diving beetle taxa in the western Palaearctic, some of which have been divided into a number of geographical subspecies. Of these, Hydroporus necopinatus is distributed in the far west of Europe, from central Spain to southern Britain, and has been split into three subspecies, occurring in Iberia (necopinatus sst.), France (robertorum) and England (roni) respectively-the last of these being a rare example of an insect taxon apparently endemic to northern Europe. Here we explore inter-relationships between populations and subspecies of H. necopinatus and related members of the Hydroporus melanarius subgroup, using mitochondrial COI sequence data. We reveal widespread discordance between mitochondrial DNA sequence variation and morphology in areas where H. necopinatus and H. melanarius come into contact, consistent with historical introgressive hybridization between these taxa. In light of this discordance, the lack of clear genetic divergence between H. necopinatus subspecies, and the fact that both robertorum and roni are morphologically intermediate between H. necopinatus sstr. and H. melanarius, we suggest that these taxa may be of hybridogenic origin, rather than representing discrete evolutionary lineages.
Underwood, S Richard; Bax, Jeroen J; vom Dahl, Jürgen; Henein, Michael Y; Knuuti, Juhani; van Rossum, Albert C; Schwarz, Ernst R; Vanoverschelde, Jean-Louis; van der Wall, Ernst E; Wijns, William
This report of an ESC Study Group reviews current knowledge on myocardial hibernation and relevant imaging techniques, and provides an algorithm for investigation and management when a patient presents with ischaemic left ventricular dysfunction. It covers the definitions of myocardial viability, stunning and hibernation, it reviews the morphological findings in hibernation and it describes relevant clinical settings. The imaging and other techniques that are reviewed are electrocardiography, positron-emitting and single photon-emitting scintigraphic imaging, echocardiography, radionuclide angiocardiography, magnetic resonance imaging, X-ray transmission tomography, invasive X-ray angiocardiography and electromechanical mapping. The evidence for the techniques to predict improvement of regional and global function after revascularisation is summarised and patient symptoms and clinical outcome are also considered. Each technique is classified in its ability to assess myocardial viability, function and perfusion and also for their roles in the assessment of the patient with ischaemic left ventricular dysfunction who is asymptomatic or who has angina or heart failure. A simplified clinical algorithm describes the initial assessment of left ventricular function, then viability and then perfusion reserve allowing regions of myocardium to be characterised as transmural scar, intramural scar, hibernation or ischaemia.
Charalambous, M; Bhatti, S F M; Van Ham, L; Platt, S; Jeffery, N D; Tipold, A; Siedenburg, J; Volk, H A; Hasegawa, D; Gallucci, A; Gandini, G; Musteata, M; Ives, E; Vanhaesebrouck, A E
Intranasal administration of benzodiazepines has shown superiority over rectal administration for terminating emergency epileptic seizures in human trials. No such clinical trials have been performed in dogs. To evaluate the clinical efficacy of intranasal midazolam (IN-MDZ), via a mucosal atomization device, as a first-line management option for canine status epilepticus and compare it to rectal administration of diazepam (R-DZP) for controlling status epilepticus before intravenous access is available. Client-owned dogs with idiopathic or structural epilepsy manifesting status epilepticus within a hospital environment were used. Dogs were randomly allocated to treatment with IN-MDZ (n = 20) or R-DZP (n = 15). Randomized parallel-group clinical trial. Seizure cessation time and adverse effects were recorded. For each dog, treatment was considered successful if the seizure ceased within 5 minutes and did not recur within 10 minutes after administration. The 95% confidence interval was used to detect the true population of dogs that were successfully treated. The Fisher's 2-tailed exact test was used to compare the 2 groups, and the results were considered statistically significant if P < .05. IN-MDZ and R-DZP terminated status epilepticus in 70% (14/20) and 20% (3/15) of cases, respectively (P = .0059). All dogs showed sedation and ataxia. IN-MDZ is a quick, safe and effective first-line medication for controlling status epilepticus in dogs and appears superior to R-DZP. IN-MDZ might be a valuable treatment option when intravenous access is not available and for treatment of status epilepticus in dogs at home. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.
Juan F. Asturiano
Full Text Available European sea bass (Dicentrarchus labrax L. is a species with group-synchronous ovarian development. A mechanism is required which enables maturation to occur in the first clutches of oocytes without inducing maturation in subsequent clutches. The present study examined the individual plasma variations of testosterone (T, 17,20?-dihydroxy-4-pregnen-3-one (17,20?P and 17,20?,21-trihydroxy-4-pregnen-3-one (20?S in both sexes, estradiol (E2 and vitellogenin (VTG in females (n=15 and 11-ketotestosterone (11KT in males (n=21, in an effort to elucidate the hormonal control of the reproductive cycle in this species. A sample of oocytes was obtained at every sampling from each female and the stage of development of the most advanced clutch of oocytes was determined and related to the individual hormone plasma levels. Total expressible milt was collected from males at each sampling during the spawning period and variations in the sperm production were related to hormone plasma levels. Successive elevations of plasma T and E2 levels were observed prior to peaks of progestagens, which resulted from the shift in gonadal steroidogenesis and coincided with the maturation-ovulation of the different clutches of oocytes or with increases in the sperm production. Following each progestagens wave, a new shift in gonadal steroidogenesis, resulting in a new elevation in plasma T and E2, was observed. This hormonal pattern was repeated several times depending on the number of ovulations per female. Results from the present study suggest a mechanism, based on shifts in gonadal steroidogenesis, which may be responsible for regulation of group-synchronous ovarian development, ovulation and spermiation in this species. In addition, evidence is presented which supports a role for both 17,20?P and 20?S as the maturation-inducing steroids (MIS in male and female European sea bass.
Liber, Juliette M.; Van Widenfelt, Brigit M.; Utens, Elisabeth M. W. J.; Ferdinand, Robert F.; Van Der Leeden, Adelinde J. M.; Van Gastel, Willemijn; Treffers, Philip D. A.
Background: The present study compares an individual versus a group format in the delivery of manualised cognitive-behavioural therapy (FRIENDS) for children with anxiety disorders. Clinically referred children (aged 8 to 12) diagnosed with Separation Anxiety Disorder (n = 52), Generalised Anxiety Disorder (n = 37), Social Phobia (n = 22) or…
Kocovski, Nancy L.; Fleming, Jan E.; Rector, Neil A.
Mindfulness and Acceptance-Based Group Therapy (MAGT) for Social Anxiety Disorder (SAD) is based largely on Acceptance and Commitment Therapy (ACT; Hayes et al., 1999), with enhanced mindfulness mostly from Mindfulness-Based Cognitive Therapy (MBCT; Segal et al., 2002). The purpose of this study was to assess the feasibility and initial…
Rilo, Oiane; Peña, Javier; Ojeda, Natalia; Rodríguez-Antigüedad, Alfredo; Mendibe-Bilbao, Mar; Gómez-Gastiasoro, Ainara; DeLuca, John; Chiaravalloti, Nancy; Ibarretxe-Bilbao, Naroa
This study aimed to determine the efficacy of the integrative group-based cognitive rehabilitation programme, REHACOP, on improving cognitive functions in multiple sclerosis (MS). Fourty-two MS patients were randomized to the treatment programme REHACOP (n = 21) or waiting list control condition (n = 21). The REHACOP group received cognitive rehabilitation in group format for three months focused on attention, processing speed, learning and memory, language, executive functioning, and social cognition. Patients completed a neuropsychological assessment at baseline and follow-up, which included tests of attention, processing speed, working memory, verbal memory, verbal fluency, and executive functioning. Repeated measures multivariate analysis of covariance (MANCOVA) was used to determine the efficacy of the cognitive rehabilitation programme. Group × Time interactions revealed significant improvements in the REHACOP group as compared with the control group for processing speed (p = 0.011, np2 = 0.16), working memory (p = 0.014, np2 = 0.15), verbal memory (p = 0.025, np2 = 0.13), and executive functioning (p = 0.024, np2 = 0.13), showing medium-large effect sizes. Patients receiving REHACOP showed improvements in several cognitive domains. This preliminary study thus provides evidence supporting the efficacy of this integrative group-based cognitive rehabilitation intervention in MS. Future research should confirm these findings, examine the impact of the treatment on everyday life functioning and explore the presence of brain changes associated with cognitive rehabilitation. Implications for rehabilitation This study provides initial evidence for integrative group-based cognitive rehabilitation efficacy in MS patients through the implementation of the REHACOP cognitive rehabilitation programme. Patients received cognitive rehabilitation for three months (3 one-hour-sessions per week) focused on training attention
Ciesielski, Heather A; Tamm, Leanne; Vaughn, Aaron J; Cyran, Jessica E M; Epstein, Jeffery N
To conduct an open trial assessing the initial efficacy of an intervention focusing on increasing skills related to academic performance (planning, organization, studying, and homework behaviors) for middle school children diagnosed with ADHD. The intervention is modeled on evidence-based interventions but designed for administration in the outpatient setting. Parents and their children diagnosed with ADHD attended seven weekly group sessions targeting academic, organizational, and homework skills. Parents completed the Homework Problem Checklist and Impairment Rating Scale pre- and post-treatment. Following intervention, significant improvements in homework completion and management, as well as reductions in academic impairment and improvements in parent confidence and family relations, were reported. Despite limitations including small sample size and lack of a control group, our results demonstrate initial efficacy of an academic skills intervention designed for use in the outpatient setting with middle school children diagnosed with ADHD on clinically relevant outcome measures. © 2015 SAGE Publications.
Li, Zhiguo; Gilbert, Peter; Nan, Bin
Grouped failure time data arise often in HIV studies. In a recent preventive HIV vaccine efficacy trial, immune responses generated by the vaccine were measured from a case-cohort sample of vaccine recipients, who were subsequently evaluated for the study endpoint of HIV infection at prespecified follow-up visits. Gilbert et al. (2005, Journal of Infectious Diseases 191, 666-677) and Forthal et al. (2007, Journal of Immunology 178, 6596-6603) analyzed the association between the immune responses and HIV incidence with a Cox proportional hazards model, treating the HIV infection diagnosis time as a right-censored random variable. The data, however, are of the form of grouped failure time data with case-cohort covariate sampling, and we propose an inverse selection probability-weighted likelihood method for fitting the Cox model to these data. The method allows covariates to be time dependent, and uses multiple imputation to accommodate covariate data that are missing at random. We establish asymptotic properties of the proposed estimators, and present simulation results showing their good finite sample performance. We apply the method to the HIV vaccine trial data, showing that higher antibody levels are associated with a lower hazard of HIV infection.
Bleiberg, H; Decoster, G; de Gramont, A; Rougier, P; Sobrero, A; Benson, A; Chibaudel, B; Douillard, J Y; Eng, C; Fuchs, C; Fujii, M; Labianca, R; Larsen, A K; Mitchell, E; Schmoll, H J; Sprumont, D; Zalcberg, J
In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. A simplified form of informed consent with the leading part of 1200-1800 words containing all of the key information necessary to meet ethical and regulatory requirements and 'relevant supportive information appendix' of 2000-3000 words is provided. This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content.
Decoster, G.; de Gramont, A.; Rougier, P.; Sobrero, A.; Benson, A.; Chibaudel, B.; Douillard, J. Y.; Eng, C.; Fuchs, C.; Fujii, M.; Labianca, R.; Larsen, A. K.; Mitchell, E.; Schmoll, H. J.; Sprumont, D.; Zalcberg, J.
Background In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. Methods The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. Results A simplified form of informed consent with the leading part of 1200–1800 words containing all of the key information necessary to meet ethical and regulatory requirements and ‘relevant supportive information appendix’ of 2000–3000 words is provided. Conclusions This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content. PMID:28453700
Athanasiadis, Georgios; Esteban, Esther; Via, Marc; Dugoujon, Jean-Michel; Moschonas, Nicholas; Chaabani, Hassen; Moral, Pedro
Alu elements are the most abundant mobile elements in the human genome (approximately 1,100,000 copies). Polymorphic Alu elements have been proved to be useful in studies of human origins and relationships owing to two important advantages: identity by descent and absence of the Alu element known to be the ancestral state. Alu variation in the X chromosome has been described previously in human populations but, as far as we know, these elements have not been used in population relationship studies. Here, we describe the allele frequencies of 13 'young' Alu elements of the X chromosome (Ya5DP62, Ya5DP57, Yb8DP49, Ya5a2DP1, Yb8DP2, Ya5DP3, Ya5NBC37, Yd3JX437, Ya5DP77, Ya5NBC491, Yb8NBC578, Ya5DP4 and Ya5DP13) in six human populations from sub-Saharan Africa (the Ivory Coast), North Africa (Moroccan High Atlas, Siwa oasis in Egypt, Tunisia), Greece (Crete Island) and Spain (Basque Country). Eight out of 13 Alu elements have shown remarkably high gene diversity values in all groups (average heterozygosities: 0.342 in the Ivory Coast, 0.250 in North Africa, 0.209 in Europe). Genetic relationships agree with a geographical pattern of differentiation among populations, with some peculiar features observed in North Africans. Crete Island and the Basque Country show the lowest genetic distance (0.0163) meanwhile Tunisia, in spite of its geographical location, lies far from the other two North African samples. The results of our work demonstrate that X chromosome Alu elements comprise a reliable set of genetic markers useful to describe human population relationships for fine-scale geographical studies.
Khazaal, Yasser; Chatton, Anne; Dieben, Karen; Huguelet, Philippe; Boucherie, Maria; Monney, Gregoire; Lecardeur, Laurent; Salamin, Virginie; Bretel, Fethi; Azoulay, Silke; Pesenti, Elodie; Krychowski, Raoul; Costa Prata, Andreia; Bartolomei, Javier; Brazo, Perrine; Traian, Alexei; Charpeaud, Thomas; Murys, Elodie; Poupart, Florent; Rouvière, Serge; Zullino, Daniele; Parabiaghi, Alberto; Saoud, Mohamed; Favrod, Jérôme
"Michael's game" (MG) is a card game targeting the ability to generate alternative hypotheses to explain a given experience. The main objective was to evaluate the effect of MG on delusional conviction as measured by the primary study outcome: the change in scores on the conviction subscale of the Peters delusions inventory (PDI-21). Other variables of interest were the change in scores on the distress and preoccupation subscales of the PDI-21, the brief psychiatric rating scale, the Beck cognitive insight scale, and belief flexibility assessed with the Maudsley assessment of delusions schedule (MADS). We performed a parallel, assessor-blinded, randomized controlled superiority trial comparing treatment as usual plus participation in MG with treatment as usual plus being on a waiting list (TAU) in a sample of adult outpatients with psychotic disorders and persistent positive psychotic symptoms at inclusion. The 172 participants were randomized, with 86 included in each study arm. Assessments were performed at inclusion (T1: baseline), at 3 months (T2: post-treatment), and at 6 months after the second assessment (T3: follow-up). At T2, a positive treatment effect was observed on the primary outcome, the PDI-21 conviction subscale (p = 0.005). At T3, a sustained effect was observed for the conviction subscale (p = 0.002). Further effects were also observed at T3 on the PDI-21 distress (p = 0.002) and preoccupation subscales (p = 0.001), as well as on one of the MADS measures of belief flexibility ("anything against the belief") (p = 0.001). The study demonstrated some significant beneficial effect of MG.
Full Text Available OBJECTIVE: There is a need to improve treatment for individuals with bulimic disorders. It was hypothesised that a focus in treatment on broader emotional and social/interpersonal issues underlying eating disorders would increase treatment efficacy. This study tested a novel treatment based on the above hypothesis, an Emotional and Social Mind Training Group (ESM, against a Cognitive Behavioural Therapy Group (CBT treatment. METHOD: 74 participants were randomised to either ESM or CBT Group treatment programmes. All participants were offered 13 group and 4 individual sessions. The primary outcome measure was the Eating Disorder Examination (EDE Global score. Assessments were carried out at baseline, end of treatment (four months and follow-up (six months. RESULTS: There were no differences in outcome between the two treatments. No moderators of treatment outcome were identified. Adherence rates were higher for participants in the ESM group. DISCUSSION: This suggests that ESM may be a viable alternative to CBT for some individuals. Further research will be required to identify and preferentially allocate suitable individuals accordingly. TRIAL REGISTRATION: ISRCTN61115988.
Graziano, Federica; Calandri, Emanuela; Borghi, Martina; Bonino, Silvia
To evaluate the effectiveness of a cognitive behavioral group-based intervention aimed at reducing