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Sample records for rheumatology international trials

  1. The Paediatric Rheumatology International Trials Organisation provisional criteria for the evaluation of response to therapy in juvenile dermatomyositis

    DEFF Research Database (Denmark)

    Ruperto, Nicolino; Pistorio, Angela; Ravelli, Angelo

    2010-01-01

    To develop a provisional definition for the evaluation of response to therapy in juvenile dermatomyositis (DM) based on the Paediatric Rheumatology International Trials Organisation juvenile DM core set of variables....

  2. 2016 American College of Rheumatology/European League Against Rheumatism Criteria for Minimal, Moderate, and Major Clinical Response in Juvenile Dermatomyositis An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative

    NARCIS (Netherlands)

    Rider, Lisa G.; Aggarwal, Rohit; Pistorio, Angela; Bayat, Nastaran; Erman, Brian; Feldman, Brian M.; Huber, Adam M.; Cimaz, Rolando; Cuttica, Rubén J.; de Oliveira, Sheila Knupp; Lindsley, Carol B.; Pilkington, Clarissa A.; Punaro, Marilynn; Ravelli, Angelo; Reed, Ann M.; Rouster-Stevens, Kelly; van Royen-Kerkhof, Annet; Dressler, Frank; Magalhaes, Claudia Saad; Constantin, Tamás; Davidson, Joyce E.; Magnusson, Bo; Russo, Ricardo; Villa, Luca; Rinaldi, Mariangela; Rockette, Howard; Lachenbruch, Peter A.; Miller, Frederick W.; Vencovsky, Jiri; Ruperto, Nicolino; Hansen, Paul; Apaz, Maria; Bowyer, Suzanne; Curran, Megan; Davidson, Joyce; Griffin, Thomas; Huber, Adam H.; Jones, Olcay; Kim, Susan; Lang, Bianca; Lindsley, Carol; Lovell, Daniel; Saad Magalhaes, Claudia; Pachman, Lauren M.; Pilkington, Clarissa; Ponyi, Andrea; Quartier, Pierre; Ramanan, Athimalaipet V.; Reed, Ann; Rennebohm, Robert

    2017-01-01

    Objective. To develop response criteria for juvenile dermatomyositis (DM). Methods. We analyzed the performance of 312 definitions that used core set measures from either the International Myositis Assessment and Clinical Studies Group (IMACS) or the Paediatric Rheumatology International Trials

  3. 2016 American College of Rheumatology/European League Against Rheumatism Criteria for Minimal, Moderate, and Major Clinical Response in Juvenile Dermatomyositis : An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative

    NARCIS (Netherlands)

    Rider, Lisa G.; Aggarwal, Rohit; Pistorio, Angela; Bayat, Nastaran; Erman, Brian; Feldman, Brian M.; Huber, Adam M.; Cimaz, Rolando; Cuttica, Rubén J.; De Oliveira, Sheila Knupp; Lindsley, Carol B.; Pilkington, Clarissa A.; Punaro, Marilynn; Ravelli, Angelo; Reed, Ann M.; Rouster-Stevens, Kelly; van Royen-Kerkhof, Annet; Dressler, Frank; Magalhaes, Claudia Saad; Constantin, Tamás; Davidson, Joyce E.; Magnusson, Bo; Russo, Ricardo; Villa, Luca; Rinaldi, Mariangela; Rockette, Howard; Lachenbruch, Peter A.; Miller, Frederick W.; Vencovsky, Jiri; Ruperto, Nicolino; Rider, Lisa G.; Ruperto, Nicolino; Miller, Frederick W.; Aggarwal, Rohit; Erman, Brian; Bayat, Nastaran; Pistorio, Angela; Huber, Adam M.; Feldman, Brian M.; Hansen, Paul; Rockette, Howard; Lachenbruch, Peter A.; Ruperto, Nicolino; Rider, Lisa G.; Apaz, Maria T; Bowyer, Suzanne; Cimaz, Rolando; Constantin, Tamás; Curran, Megan; Davidson, Joyce E.; Feldman, Brian M.; Griffin, Thomas; Huber, Adam H.; Jones, Olcay; Kim, Susan; Lang, Bianca; Lindsley, Carol; Lovell, Daniel J.; Saad Magalhaes, Claudia; Pachman, Lauren M.; Pilkington, Clarissa; Ponyi, Andrea; Punaro, Marilynn; Quartier, Pierre; Ramanan, Athimalaipet V; Ravelli, Angelo; Reed, Ann M.; Rennebohm, Robert; Sherry, David D.; Silva, Clovis A.; Stringer, Elizabeth; van Royen-Kerkhof, Annet; Wallace, Carol; Miller, Frederick W.; Oddis, Chester V.; Reed, Ann M.; Rider, Lisa G.; Ruperto, Nicolino; Apaz, Maria T; Avcin, Tadej; Becker, Mara; Beresford, Michael W.; Cimaz, Rolando; Constantin, Tamás; Curran, Megan; Cuttica, Ruben; Davidson, Joyce E.; Dressler, Frank; Dvergsten, Jeffrey; Feitosa de Oliveira, Sheila Knupp; Feldman, Brian M.; Leme Ferriani, Virginia Paes; Flato, Berit; Gerloni, Valeria; Griffin, Thomas; Henrickson, Michael; Hinze, Claas; Hoeltzel, Mark; Huber, Adam M.; Ibarra, Maria; Ilowite, Norman T; Imundo, Lisa; Jones, Olcay; Kim, Susan; Kingsbury, Daniel; Lang, Bianca; Lindsley, Carol; Lovell, Daniel J.; Martini, Alberto; Saad Magalhaes, Claudia; Magnusson, Bo; Maguiness, Sheilagh; Maillard, Susan; Mathiesen, Pernille; McCann, Liza J.; Nielsen, Susan; Pachman, Lauren M.; Passo, Murray; Pilkington, Clarissa; Punaro, Marilynn; Quartier, Pierre; Rabinovich, Egla; Ramanan, Athimalaipet V; Ravelli, Angelo; Reed, Ann M.; Rennebohm, Robert; Rider, Lisa G.; Rivas-Chacon, Rafael; Byun Robinson, Angela; Rouster-Stevens, Kelly; Russo, Ricardo; Rutkowska-Sak, Lidia; Sallum, Adriana; Sanner, Helga; Schmeling, Heinrike; Selcen, Duygu; Shaham, Bracha; Sherry, David D.; Silva, Clovis A.; Spencer, Charles H.; Sundel, Robert; Tardieu, Marc; Thatayatikom, Akaluck; van der Net, Janjaap; van Royen-Kerkhof, Annet; Wahezi, Dawn; Wallace, Carol; Zulian, Francesco; analysis, Conjoint; Cimaz, Rolando; Constantin, Tamás; Cuttica, Ruben; Davidson, Joyce E.; Dressler, Frank; Knupp Feitosa de Oliveira, Sheila; Feldman, Brian M.; Griffin, Thomas; Henrickson, Michael; Huber, Adam M.; Imundo, Lisa; Lang, Bianca; Lindsley, Carol; Saad Magalhaes, Claudia; Magnusson, Bo; Maillard, Susan; Pachman, Lauren M.; Passo, Murray; Pilkington, Clarissa; Punaro, Marilynn; Ravelli, Angelo; Reed, Ann M.; Rider, Lisa G.; Rouster-Stevens, Kelly; Russo, Ricardo; Shaham, Bracha; Sundel, Robert; van der Net, Janjaap; van Royen-Kerkhof, Annet; Cimaz, Rolando; Cuttica, Rubén J.; Knupp Feitosa de Oliveira, Sheila; Feldman, Brian M.; Huber, Adam M.; Lindsley, Carol B.; Pilkington, Clarissa; Punaro, Marilynn; Ravelli, Angelo; Reed, Ann M.; Rouster-Stevens, Kelly; van Royen-Kerkhof, Annet; Amato, Anthony A; Chinoy, Hector; Cooper, Robert G.; Dastmalchi, Maryam; de Visser, Marianne; Fiorentino, David; Isenberg, David; Katz, James; Mammen, Andrew; Oddis, Chester V.; Ytterberg, Steven R.

    2017-01-01

    Objective: To develop response criteria for juvenile dermatomyositis (DM). Methods: We analyzed the performance of 312 definitions that used core set measures from either the International Myositis Assessment and Clinical Studies Group (IMACS) or the Paediatric Rheumatology International Trials

  4. The Paediatric Rheumatology International Trials Organisation provisional criteria for the evaluation of response to therapy in juvenile dermatomyositis.

    Science.gov (United States)

    Ruperto, Nicolino; Pistorio, Angela; Ravelli, Angelo; Rider, Lisa G; Pilkington, Clarissa; Oliveira, Sheila; Wulffraat, Nico; Espada, Graciela; Garay, Stella; Cuttica, Ruben; Hofer, Michael; Quartier, Pierre; Melo-Gomes, Jose; Reed, Ann M; Wierzbowska, Malgorzata; Feldman, Brian M; Harjacek, Miroslav; Huppertz, Hans-Iko; Nielsen, Susan; Flato, Berit; Lahdenne, Pekka; Michels, Harmut; Murray, Kevin J; Punaro, Lynn; Rennebohm, Robert; Russo, Ricardo; Balogh, Zsolt; Rooney, Madeleine; Pachman, Lauren M; Wallace, Carol; Hashkes, Philip; Lovell, Daniel J; Giannini, Edward H; Gare, Boel Andersson; Martini, Alberto

    2010-11-01

    To develop a provisional definition for the evaluation of response to therapy in juvenile dermatomyositis (DM) based on the Paediatric Rheumatology International Trials Organisation juvenile DM core set of variables. Thirty-seven experienced pediatric rheumatologists from 27 countries achieved consensus on 128 difficult patient profiles as clinically improved or not improved using a stepwise approach (patient's rating, statistical analysis, definition selection). Using the physicians' consensus ratings as the "gold standard measure," chi-square, sensitivity, specificity, false-positive and-negative rates, area under the receiver operating characteristic curve, and kappa agreement for candidate definitions of improvement were calculated. Definitions with kappa values >0.8 were multiplied by the face validity score to select the top definitions. The top definition of improvement was at least 20% improvement from baseline in 3 of 6 core set variables with no more than 1 of the remaining worsening by more than 30%, which cannot be muscle strength. The second-highest scoring definition was at least 20% improvement from baseline in 3 of 6 core set variables with no more than 2 of the remaining worsening by more than 25%, which cannot be muscle strength (definition P1 selected by the International Myositis Assessment and Clinical Studies group). The third is similar to the second with the maximum amount of worsening set to 30%. This indicates convergent validity of the process. We propose a provisional data-driven definition of improvement that reflects well the consensus rating of experienced clinicians, which incorporates clinically meaningful change in core set variables in a composite end point for the evaluation of global response to therapy in juvenile DM. Copyright © 2010 by the American College of Rheumatology.

  5. 2016 American College of Rheumatology/European League Against Rheumatism Criteria for Minimal, Moderate, and Major Clinical Response in Juvenile Dermatomyositis: An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative.

    Science.gov (United States)

    Rider, Lisa G; Aggarwal, Rohit; Pistorio, Angela; Bayat, Nastaran; Erman, Brian; Feldman, Brian M; Huber, Adam M; Cimaz, Rolando; Cuttica, Rubén J; de Oliveira, Sheila Knupp; Lindsley, Carol B; Pilkington, Clarissa A; Punaro, Marilynn; Ravelli, Angelo; Reed, Ann M; Rouster-Stevens, Kelly; van Royen-Kerkhof, Annet; Dressler, Frank; Saad Magalhaes, Claudia; Constantin, Tamás; Davidson, Joyce E; Magnusson, Bo; Russo, Ricardo; Villa, Luca; Rinaldi, Mariangela; Rockette, Howard; Lachenbruch, Peter A; Miller, Frederick W; Vencovsky, Jiri; Ruperto, Nicolino

    2017-05-01

    To develop response criteria for juvenile dermatomyositis (DM). We analysed the performance of 312 definitions that used core set measures from either the International Myositis Assessment and Clinical Studies Group (IMACS) or the Paediatric Rheumatology International Trials Organisation (PRINTO) and were derived from natural history data and a conjoint analysis survey. They were further validated using data from the PRINTO trial of prednisone alone compared to prednisone with methotrexate or cyclosporine and the Rituximab in Myositis (RIM) trial. At a consensus conference, experts considered 14 top candidate criteria based on their performance characteristics and clinical face validity, using nominal group technique. Consensus was reached for a conjoint analysis-based continuous model with a total improvement score of 0-100, using absolute per cent change in core set measures of minimal (≥30), moderate (≥45), and major (≥70) improvement. The same criteria were chosen for adult DM/polymyositis, with differing thresholds for improvement. The sensitivity and specificity were 89% and 91-98% for minimal improvement, 92-94% and 94-99% for moderate improvement, and 91-98% and 85-86% for major improvement, respectively, in juvenile DM patient cohorts using the IMACS and PRINTO core set measures. These criteria were validated in the PRINTO trial for differentiating between treatment arms for minimal and moderate improvement (p=0.009-0.057) and in the RIM trial for significantly differentiating the physician's rating for improvement (p<0.006). The response criteria for juvenile DM consisted of a conjoint analysis-based model using a continuous improvement score based on absolute per cent change in core set measures, with thresholds for minimal, moderate, and major improvement. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  6. 2016 American College of Rheumatology/European League Against Rheumatism criteria for minimal, moderate, and major clinical response in adult dermatomyositis and polymyositis: An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative.

    Science.gov (United States)

    Aggarwal, Rohit; Rider, Lisa G; Ruperto, Nicolino; Bayat, Nastaran; Erman, Brian; Feldman, Brian M; Oddis, Chester V; Amato, Anthony A; Chinoy, Hector; Cooper, Robert G; Dastmalchi, Maryam; Fiorentino, David; Isenberg, David; Katz, James D; Mammen, Andrew; de Visser, Marianne; Ytterberg, Steven R; Lundberg, Ingrid E; Chung, Lorinda; Danko, Katalin; García-De la Torre, Ignacio; Song, Yeong Wook; Villa, Luca; Rinaldi, Mariangela; Rockette, Howard; Lachenbruch, Peter A; Miller, Frederick W; Vencovsky, Jiri

    2017-05-01

    To develop response criteria for adult dermatomyositis (DM) and polymyositis (PM). Expert surveys, logistic regression, and conjoint analysis were used to develop 287 definitions using core set measures. Myositis experts rated greater improvement among multiple pairwise scenarios in conjoint analysis surveys, where different levels of improvement in 2 core set measures were presented. The PAPRIKA (Potentially All Pairwise Rankings of All Possible Alternatives) method determined the relative weights of core set measures and conjoint analysis definitions. The performance characteristics of the definitions were evaluated on patient profiles using expert consensus (gold standard) and were validated using data from a clinical trial. The nominal group technique was used to reach consensus. Consensus was reached for a conjoint analysis-based continuous model using absolute per cent change in core set measures (physician, patient, and extramuscular global activity, muscle strength, Health Assessment Questionnaire, and muscle enzyme levels). A total improvement score (range 0-100), determined by summing scores for each core set measure, was based on improvement in and relative weight of each core set measure. Thresholds for minimal, moderate, and major improvement were ≥20, ≥40, and ≥60 points in the total improvement score. The same criteria were chosen for juvenile DM, with different improvement thresholds. Sensitivity and specificity in DM/PM patient cohorts were 85% and 92%, 90% and 96%, and 92% and 98% for minimal, moderate, and major improvement, respectively. Definitions were validated in the clinical trial analysis for differentiating the physician rating of improvement (p<0.001). The response criteria for adult DM/PM consisted of the conjoint analysis model based on absolute per cent change in 6 core set measures, with thresholds for minimal, moderate, and major improvement. Published by the BMJ Publishing Group Limited. For permission to use (where not

  7. [INTERNATIONAL COOPERATION IN PEDIATRIC RHEUMATOLOGY: THE SHARE PROJECT].

    Science.gov (United States)

    Uziel, Yosef

    2017-07-01

    The SHARE initiative is a project initiated by the European Society of Pediatric Rheumatology for the purpose of improving clinical care in the field of pediatric rheumatology. Towards this goal numerous working plans and surveys were conducted. All pediatric rheumatology centers were mapped in terms of staff members, quality and types of treatments in each country, in order to improve and plan the best way for the diagnosis and treatment of rheumatic disease in children. After termination of the optimal clinical approach and care, position papers were written including all recommendations based on the scientific literature in the field. In addition, recommendations were set regarding the encouragement of international research, especially in light of the major advances achieved in the genetic aspects of pediatric rheumatology diseases, and the need for sharing biological samples between researchers from different countries and continents. Information for patients became more available regarding the diseases and the medical centers in each country. Futhermore, educational programs for interns and young fellows were written for the promotion of higher and identical academic levels in different countries.

  8. Proceedings from the 7th Annual International Society for Musculoskeletal Imaging in Rheumatology (ISEMIR) conference

    DEFF Research Database (Denmark)

    Troum, Orrin M; Pimienta, Olga L; Schmidt, Wolfgang A

    2015-01-01

    The International Society for Musculoskeletal Imaging in Rheumatology (ISEMIR) was founded in 2005 with the goal of discussing matters related to imaging in rheumatology, particularly, validation, education, and use in clinical practice and research. Because the field of musculoskeletal (MSK...

  9. Proceedings from The 8th Annual International Society for Musculoskeletal Imaging in Rheumatology (ISEMIR) Conference

    DEFF Research Database (Denmark)

    Troum, Orrin M; Pimienta, Olga L; Olech, Ewa

    2016-01-01

    The International Society for Musculoskeletal Imaging in Rheumatology (ISEMIR) was founded in 2005 with the goal of discussing matters related to imaging in rheumatology, particularly, validation, education, and use in both clinical practice and research. The field of musculoskeletal (MSK) imaging...... is continuously evolving; therefore, education for healthcare providers in this field is of paramount importance. ISEMIR's international faculty and world-renowned experts presented the newest information as it relates to the use of magnetic resonance imaging (MRI) and ultrasound (US) at the 8th annual ISEMIR...

  10. Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials

    DEFF Research Database (Denmark)

    Klokker, Louise; Tugwell, Peter; Furst, Daniel E

    2016-01-01

    in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. METHODS: The safety......OBJECTIVE: Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety...... that patients consider relevant so that they will be able to make informed decisions. CONCLUSION: The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach....

  11. Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group.

    Science.gov (United States)

    Klokker, Louise; Tugwell, Peter; Furst, Daniel E; Devoe, Dan; Williamson, Paula; Terwee, Caroline B; Suarez-Almazor, Maria E; Strand, Vibeke; Woodworth, Thasia; Leong, Amye L; Goel, Niti; Boers, Maarten; Brooks, Peter M; Simon, Lee S; Christensen, Robin

    2017-12-01

    Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. The safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms were included in COS. Our methods include (1) identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, (2) identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved. Members of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety-related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions. The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach.

  12. Current trends in medical English education and the Japan College of Rheumatology International School.

    Science.gov (United States)

    Jego, Eric Hajime; Amengual, Olga

    2017-11-01

    In light of the present revolution happening in medical education in Japan as medical schools implement new curricula to conform to global standards, there is a growing demand for more internationalization and higher quality practical medical English education. In response, many institutions including governmental organizations, universities and academic associations are moving ahead with new initiatives to adapt to these changing demands. This paper reviews the current trends and innovations in medical English education in Japan. This paper also describes one initiative by the Japan College of Rheumatology (JCR) known as the JCR International School held yearly in Karuizawa. By examining recent trends and innovations in medical English education in Japan, the most relevant and applicable can be elucidated to illuminate a path forward for improved medical English education within the JCR.

  13. Policy challenges for the pediatric rheumatology workforce: Part III. the international situation

    Directory of Open Access Journals (Sweden)

    Henrickson Michael

    2011-09-01

    Full Text Available Abstract Survival dominates current pediatric global health priorities. Diseases of poverty largely contribute to overall mortality in children under 5 years of age. Infectious diseases and injuries account for 75% of cause-specific mortality among children ages 5-14 years. Twenty percent of the world's population lives in extreme poverty (income below US $1.25/day. Within this population, essential services and basic needs are not met, including clean water, sanitation, adequate nutrition, shelter, access to health care, medicines and education. In this context, musculoskeletal disease comprises 0.1% of all-cause mortality in children ages 5-14 years. Worldwide morbidity from musculoskeletal disease remains generally unknown in the pediatric age group. This epidemiologic data is not routinely surveyed by international agencies, including the World Health Organization. The prevalence of pediatric rheumatic diseases based on data from developed nations is in the range of 2,500 - 3,000 cases per million children. Developing countries' needs for musculoskeletal morbidity are undergoing an epidemiologic shift to chronic conditions, as leading causes of pediatric mortality are slowly quelled. A global crisis of health care providers and human resources stems from insufficient workforce production, inability to retain workers in areas of greatest need, distribution disparity and poor management of both health care systems and health workforce. Internationally, the pediatric rheumatology workforce will also be in very short supply for the foreseeable future relative to projected demand. Physician extenders are an essential resource to meet this demand in underserved regions. They can be trained in common aspects of musculoskeletal medicine and rheumatic conditions. Innovative strategies have been introduced in the United Kingdom to address musculoskeletal medicine educational deficiencies. Telemedicine offers an important capacity to improve access to

  14. Promoting transparent and accurate reporting of research studies in rheumatology: endorsement of reporting guidelines in rheumatology journals.

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    Marušić, Ana; Gasparyan, Armen Yuri; Kitas, George D

    2013-10-01

    To adequately translate research into practice, research results should be reported in a way that is useful to practicing clinicians and policymakers. Based on evidence from systematic reviews, the implementation of reporting guidelines, such as CONSORT for randomized controlled trials, may improve the quality of research reporting. We assessed the endorsement of reporting guidelines in rheumatology journals. We analyzed guidelines for authors of all (n = 28) journals indexed in the "Rheumatology" Subject Category of the Journal Citation Reports published in 2012. Journal websites were reviewed for information relevant to reporting guidelines. Out of 28 indexed journals, only about a third (n = 10) endorsed 1 or more reporting guidelines, most commonly CONSORT. General editorial policies, such as those from the International Committee of Medical Journal editors (ICMJE), were endorsed by 19 journals (all 10 journals with and 9 out of 18 without reporting guidelines). Two rheumatology journals introduced specific reporting guidelines about economic studies and genetic association studies. The endorsement of reporting guidelines is low in rheumatology journals. To continue to serve their research community, rheumatology journals should provide the platform for the discussion on most relevant reporting guidelines and adopt them as a group, especially those specific for rheumatology research. Coordinated action of journals and other stakeholders in rheumatology research in the promotion of accurate and transparent reporting of health research studies would be an important part of knowledge translation into practice and well-being of rheumatology patients. Copyright © 2013 Elsevier Inc. All rights reserved.

  15. Etoricoxib (arcoxia in rheumatology

    Directory of Open Access Journals (Sweden)

    Fatima Magomedovna Kudaeva

    2011-06-01

    Full Text Available The paper gives information on the selective COX-2 inhibitor etoricoxib registered for use in many countries of the world. It gives a brief description of a few key trials of the efficacy and tolerability of etoricoxib in rheumatology

  16. Etoricoxib (arcoxia in rheumatology

    Directory of Open Access Journals (Sweden)

    Fatima Magomedovna Kudaeva

    2011-01-01

    Full Text Available The paper gives information on the selective COX-2 inhibitor etoricoxib registered for use in many countries of the world. It gives a brief description of a few key trials of the efficacy and tolerability of etoricoxib in rheumatology

  17. American College of Rheumatology/European League against Rheumatism Preliminary Definition of Remission in Rheumatoid Arthritis for Clinical Trials

    Science.gov (United States)

    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

    2010-01-01

    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

  18. Specialized rheumatology nurse substitutes for rheumatologists in the diagnostic process of fibromyalgia: a cost-consequence analysis and a randomized controlled trial

    NARCIS (Netherlands)

    Kroese, Mariëlle E.; Severens, Johan L.; Schulpen, Guy J.; Bessems, Monique C.; Nijhuis, Frans J.; Landewé, Robert B.

    2011-01-01

    To perform a cost-consequence analysis of the substitution of specialized rheumatology nurses (SRN) for rheumatologists (RMT) in the diagnostic process of fibromyalgia (FM), using both a healthcare and societal perspective and a 9-month period. Alongside a randomized controlled trial, we measured

  19. Leprosy Mimicking Common Rheumatologic Entities: A Trial for the Clinician in the Era of Biologics

    Directory of Open Access Journals (Sweden)

    Deepak Rath

    2014-01-01

    Full Text Available Rheumatoid arthritis and seronegative spondyloarthritis, which make up the lion’s share of cases attending a rheumatology clinic, are relatively easy to diagnose. However, when an entity of infective aetiology like leprosy known to be a great mimic of different autoimmune conditions presents with features similar to these, the possibility of it being diagnosed at the outset is very slim indeed. The ease with which the diagnosis of leprosy can be missed assumes sinister proportions as the use of disease modifying agents can have deleterious effects in these patients. In the era of increasing availability and use of biologic disease modifying agents, it is imperative not only to actively rule out the presence of leprosy but also to make it a part of the prebiologic screening of patients in whom biologics are being planned to be administered, especially in leprosy endemic areas.

  20. Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology

    NARCIS (Netherlands)

    Buch, Maya H.; Silva-Fernandez, Lucia; Carmona, Loreto; Aletaha, Daniel; Christensen, Robin; Combe, Bernard; Emery, Paul; Ferraccioli, Gianfranco; Guillemin, Francis; Kvien, Tore K.; Landewe, Robert; Pavelka, Karel; Saag, Kenneth; Smolen, Josef S.; Symmons, Deborah; van der Heijde, Désirée; Welling, Joep; Wells, George; Westhovens, Rene; Zink, Angela; Boers, Maarten

    2015-01-01

    Our initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports. We formed a task

  1. Biologic agents in rheumatology: unmet issues after 200 trials and $200 billion sales.

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    Ioannidis, John P A; Karassa, Fotini B; Druyts, Eric; Thorlund, Kristian; Mills, Edward J

    2013-11-01

    Anti-TNF agents and other biologic therapies are widely prescribed for a variety of indications, with total sales that exceed $200 billion to date. In rheumatic diseases, biologic agents have now been studied in more than 200 randomized clinical trials and over 100 subsequent meta-analyses; however, the information obtained does not always meet the needs of patients and clinicians. In this Review, we discuss the current issues concerning the evidence derived from such studies: potential biases favouring positive results; a paucity of head-to-head comparisons between biologically active agents; overwhelming involvement of manufacturer sponsors in trials and in the synthesis of the evidence; the preference for trials with limited follow-up; and the potential for spurious findings on adverse events, leading to endless debates about malignancy risk. We debate the responsibilities of regulatory authorities, the pharmaceutical industry and academia in attempting to solve these shortcomings and challenges. We propose that improvements in the evidence regarding biologic treatments that are continually being added to the therapeutic armamentarium for rheumatic diseases might require revisiting the design and conduct of studies. For example, trials with long-term follow-up that are independent of the pharmaceutical industry, head-to-head comparisons of therapeutic agents and the use of rigorous clinical outcomes should be considered, and public availability of raw data endorsed.

  2. Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology

    DEFF Research Database (Denmark)

    Buch, Maya H; Silva-Fernandez, Lucia; Carmona, Loreto

    2015-01-01

    OBJECTIVES: Our initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports....... The resulting set of recommendations was further refined and a final vote taken for task force acceptance. RESULTS: Seven key domains and individual components were evaluated and led to agreed recommendations including definition of a TES (100% agreement), minimal data necessary (100% agreement), method of data...... analysis (agreement mean (SD) scores ranging between 7.9 (0.84) and 9.0 (2.16)) and reporting of results as well as ethical issues. Key recommendations included reporting of absolute numbers at each stage from the RCT to TES with reasons given for drop-out at each stage, and inclusion of a flowchart...

  3. Content comparison of occupation-based instruments in adult rheumatology and musculoskeletal rehabilitation based on the International Classification of Functioning, Disability and Health.

    Science.gov (United States)

    Stamm, Tanja A; Cieza, Alarcos; Machold, Klaus P; Smolen, Josef S; Stucki, Gerold

    2004-12-15

    To compare the content of clinical, occupation-based instruments that are used in adult rheumatology and musculoskeletal rehabilitation in occupational therapy based on the International Classification of Functioning, Disability and Health (ICF). Clinical instruments of occupational performance and occupation in adult rehabilitation and rheumatology were identified in a literature search. All items of these instruments were linked to the ICF categories according to 10 linking rules. On the basis of the linking, the content of these instruments was compared and the relationship between the capacity and performance component explored. The following 7 instruments were identified: the Canadian Occupational Performance Measure, the Assessment of Motor and Process Skills, the Sequential Occupational Dexterity Assessment, the Jebson Taylor Hand Function Test, the Moberg Picking Up Test, the Button Test, and the Functional Dexterity Test. The items of the 7 instruments were linked to 53 different ICF categories. Five items could not be linked to the ICF. The areas covered by the 7 occupation-based instruments differ importantly: The main focus of all 7 instruments is on the ICF component activities and participation. Body functions are covered by 2 instruments. Two instruments were linked to 1 single ICF category only. Clinicians and researchers who need to select an occupation-based instrument must be aware of the areas that are covered by this instrument and the potential areas that are not covered at all.

  4. Discordant American College of Physicians and international rheumatology guidelines for gout management: consensus statement of the Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN).

    Science.gov (United States)

    Dalbeth, Nicola; Bardin, Thomas; Doherty, Michael; Lioté, Frédéric; Richette, Pascal; Saag, Kenneth G; So, Alexander K; Stamp, Lisa K; Choi, Hyon K; Terkeltaub, Robert

    2017-09-01

    In November 2016, the American College of Physicians (ACP) published a clinical practice guideline on the management of acute and recurrent gout. This guideline differs substantially from the latest guidelines generated by the American College of Rheumatology (ACR), European League Against Rheumatism (EULAR) and 3e (Evidence, Expertise, Exchange) Initiative, despite reviewing largely the same body of evidence. The Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN) convened an expert panel to review the methodology and conclusions of these four sets of guidelines and examine possible reasons for discordance between them. The G-CAN position, presented here, is that the fundamental pathophysiological knowledge underlying gout care, and evidence from clinical experience and clinical trials, supports a treat-to-target approach for gout aimed at lowering serum urate levels to below the saturation threshold at which monosodium urate crystals form. This practice, which is truly evidence-based and promotes the steady reduction in tissue urate crystal deposits, is promoted by the ACR, EULAR and 3e Initiative recommendations. By contrast, the ACP does not provide a clear recommendation for urate-lowering therapy (ULT) for patients with frequent, recurrent flares or those with tophi, nor does it recommend monitoring serum urate levels of patients prescribed ULT. Results from emerging clinical trials that have gout symptoms as the primary end point are expected to resolve this debate for all clinicians in the near term future.

  5. ERGOTHERAPY IN RHEUMATOLOGY

    OpenAIRE

    Tat’yana Vladimirovna Dubinina; M L Sukhareva; Sh F Erdes

    2014-01-01

    The article reports one of the most affordable rehabilitation methods, i.e. occupational therapy. The issues related to the history of occupational therapy as a treatment method, its application in rheumatology and promising directions of development are covered.

  6. History of rheumatology

    Directory of Open Access Journals (Sweden)

    Shrikant Deshpande

    2014-01-01

    Full Text Available This article describes the history and various milestones of rheumatology from ancient to modern times. The origin of rheumatology can be traced to ancient times. Diseases such as gout and osteoarthritis were prevalent in ancient people. Many ancient skeletons show signs of gout and osteoarthritis. The ancient book on Indian Medicine, Charaka Samhita, gives a vivid description of many variants of arthritis. Charaka, an eminent Ayurvedic physician, described rheumatoid arthritis (RA in Charaka Samhitha as "Vishkantha," meaning painful joints. The word rheumatology has its origin in the word "rheuma," which means flowing, and is mentioned in Hippocratic corpus. Hippocrates made several observations about gout, popularly known as "aphorisms of gout." Many famous paintings in the medieval era depict joint diseases. Hand lesions resembling those of RA are found in paintings of the Flemish school. "The virgin with canon van der paele," a painting by Jan Van Eyck (1436, shows thickened arteries in the temple, suggestive of temporal arthritis. The famous portrait of Federigo de Montefeltre, thought to have been painted by Joos (Justus van Gent, shows arthritis of the proximal interphalangeal joint of the left index finger. Rheumatology developed as a well-recognized specialty of medicine in the 20th century. American Physicians Bernard Comroe and Joseph Lee Hollander coined the term rheumatologist in 1940. Rheumatology has rapidly advanced during the last 50 years due to improved diagnosis as a result of progress in immunology, molecular biology, genetics and imaging.

  7. African Journal of Rheumatology

    African Journals Online (AJOL)

    The journal aims to publish papers on basic and clinical research in rheumatology and be a vessel of sharing knowledge across the globe. Original research work, reviews, case reports and other relevant scientific work will be published in the journal. The readers of the journal are mainly practicing rheumatologists, ...

  8. Educational issues in Rheumatology

    NARCIS (Netherlands)

    Rasker, Johannes J.; Dequeker, Jan; Woolf, Anthony D.

    2000-01-01

    Musculoskeletal conditions are the most common cause of severe long-term pain and physical disability, affecting hundreds of millions of people around the world. Nearly a quarter of all consultations in primary care are concerned with rheumatic disease, yet undergraduate education in rheumatology is

  9. ERGOTHERAPY IN RHEUMATOLOGY

    Directory of Open Access Journals (Sweden)

    Tat’yana Vladimirovna Dubinina

    2014-01-01

    Full Text Available The article reports one of the most affordable rehabilitation methods, i.e. occupational therapy. The issues related to the history of occupational therapy as a treatment method, its application in rheumatology and promising directions of development are covered.

  10. Textbook of rheumatology

    International Nuclear Information System (INIS)

    Turner, R.A.; Wise, C.M.

    1986-01-01

    This book contains 23 papers. Some of the titles are: Diagnostic Radiology in the Rheumatic Diseases; Laboratory Testing in Rheumatology; Arthritis Nursing and the Team Approach in the Management of Rheumatic Disease; The Surgical Management of Arthritis; Vasculities; Neoplasms of Bone and Joints; and Rheumatic Disease of Childhood

  11. Performance on the adult rheumatology in-training examination and relationship to outcomes on the rheumatology certification examination.

    Science.gov (United States)

    Lohr, Kristine M; Clauser, Amanda; Hess, Brian J; Gelber, Allan C; Valeriano-Marcet, Joanne; Lipner, Rebecca S; Haist, Steven A; Hawley, Janine L; Zirkle, Sarah; Bolster, Marcy B

    2015-11-01

    The American College of Rheumatology (ACR) Adult Rheumatology In-Training Examination (ITE) is a feedback tool designed to identify strengths and weaknesses in the content knowledge of individual fellows-in-training and the training program curricula. We determined whether scores on the ACR ITE, as well as scores on other major standardized medical examinations and competency-based ratings, could be used to predict performance on the American Board of Internal Medicine (ABIM) Rheumatology Certification Examination. Between 2008 and 2012, 629 second-year fellows took the ACR ITE. Bivariate correlation analyses of assessment scores and multiple linear regression analyses were used to determine whether ABIM Rheumatology Certification Examination scores could be predicted on the basis of ACR ITE scores, United States Medical Licensing Examination scores, ABIM Internal Medicine Certification Examination scores, fellowship directors' ratings of overall clinical competency, and demographic variables. Logistic regression was used to evaluate whether these assessments were predictive of a passing outcome on the Rheumatology Certification Examination. In the initial linear model, the strongest predictors of the Rheumatology Certification Examination score were the second-year fellows' ACR ITE scores (β = 0.438) and ABIM Internal Medicine Certification Examination scores (β = 0.273). Using a stepwise model, the strongest predictors of higher scores on the Rheumatology Certification Examination were second-year fellows' ACR ITE scores (β = 0.449) and ABIM Internal Medicine Certification Examination scores (β = 0.276). Based on the findings of logistic regression analysis, ACR ITE performance was predictive of a pass/fail outcome on the Rheumatology Certification Examination (odds ratio 1.016 [95% confidence interval 1.011-1.021]). The predictive value of the ACR ITE score with regard to predicting performance on the Rheumatology Certification Examination

  12. BIOSIMILARS IN RHEUMATOLOGY

    Directory of Open Access Journals (Sweden)

    E. L. Nasonov

    2016-01-01

    Full Text Available One of the most striking achievements in the pharmacotherapy of rheumatoid arthritis (RA and other human immunoinflammatory diseases (IIDs late in the 20th century is associated with the design of a fundamentally new group of medications that received the name biological agents (BAs. However, the introduction of innovative BAs into clinical practice not only could enhance the efficiency of therapy and improve prognosis in patients with the most severe forms of IIDs, but has also led to a dramatic increase in the cost of treatment. Progress in the design of biosimilars is related to many factors, including expiry of the term of patents for many brand-name BAs, such as infliximab, adalimumab, etanercept, and rituximab. Over the last 5 years, a large number of biosimilars have been designed and their design is being continued. The European Medicines Agency, the World Health Organization, and the U.S. Food and Drug Administration have developed a regulatory framework and general requirements for the manufacture and characteristics of biosimilars. Federal Law No. 429-FZ «On Amendments to the Federal Law "On Circulation of Medicines"» dated December 22, 2014 defines a biosimilar drug as a biological medicine product that is similar to the parameters of quality, efficiency, and safety with the reference biologic drug in the same formulation, and the same route of administration. The review presents an update on the requirements for biosimilars used to treat IIDs, their interchangeability and promises in further clinical application. Particular emphasis is laid on the chimeric monoclonal antibodies to tumor necrosis factor-α infliximab biosimilar Flammegis (Egis Pharmaceuticals, Hungary, that has been registered in Russia for the treatment of RA, ankylosing spondylitis and other IIDs, as well as the chimeric monoclonal antibodies to B-lymphocytes rituximab biosimilar Acellbia in a phase III clinical trial that is in the closing

  13. [Rehabilitation in rheumatology].

    Science.gov (United States)

    Luttosch, F; Baerwald, C

    2010-10-01

    Rehabilitation in rheumatology focuses on prevention of functional disorders of the musculoskeletal system, maintenance of working ability and prevention of care dependency. Drug treatment alone rarely results in long-term remission, therefore rehabilitative measures must be integrated into rheumatic care. Rehabilitative therapy in rheumatology includes physiotherapy, patient education and occupational therapy. Positive effects of physical therapy methods have been proven by various studies. Patient education and occupational therapy are important tools for stabilizing the course of the disease. To maintain positive rehabilitative results patients have to be involved in the selection of treatment measures and should take an active part in the long-term treatment process. Despite proven efficacy of physical measures there is evidence for a lack of utilization of rehabilitative therapy due to increasing cost pressure in the health care system which will further increase over time.

  14. PROCALCITONIN TESTING IN RHEUMATOLOGY

    Directory of Open Access Journals (Sweden)

    D. V. Bukhanova

    2017-01-01

    Full Text Available Currently, differential diagnosis of systemic bacterial infection and active rheumatic process remains a challenging problem in rheumatology. In the review, current data on the role of procalcitonin biomarker in diagnosis and differential diagnosis of rheumatic diseases (RD and infectious pathology are presented. In particular, some authors recommend procalcitonin (PCT test as a marker of bacterial infection in bones and joints at levels above 0.5 ng/ml; at PCT level below 0.3 ng/ml, infection can be ruled out. In patients with microcrystalline arthritis, data on the significance of PCT for differential diagnosis are contradictory. PCT level doesn’t correlate with systemic lupus erythematosus activity and is elevated only during bacterial infection proportionally to its systematicity. In some studies, elevated PCT level was observed in ANCA-associated vasculitis with high activity without bacterial infection. It was shown that in 80 % of adults with Still’s disease, PCT level was higher than the threshold value even without infection. For patients with RD hospitalized in intensive care units, PCT clearance is a more informative predictive characteristic than its level, regardless of the cause of PCT elevation (infection, injury, severe organ damage, etc.; slowdown of its decrease is a factor of poor prognosis and is associated with higher mortality. At the same time, PCT level positively correlates with the SOFA score in presence of bacterial infection. For some rheumatic diseases, the threshold PCT value at which the test has optimal sensitivity and specificity is yet to be established. Nonetheless, PCT should be evaluated in relation to the clinical picture and data of additional examinations. The effect of various therapy methods used in rheumatology on PCT level requires further research.

  15. Expanding access to rheumatology care: the rheumatology general practice toolbox.

    LENUS (Irish Health Repository)

    Conway, R

    2015-02-01

    Management guidelines for many rheumatic diseases are published in specialty rheumatology literature but rarely in general medical journals. Musculoskeletal disorders comprise 14% of all consultations in primary care. Formal post-graduate training in rheumatology is limited or absent for many primary care practitioners. Primary care practitioners can be trained to effectively treat complex diseases and have expressed a preference for interactive educational courses. The Rheumatology General Practice (GP) Toolbox is an intensive one day course designed to offer up to date information to primary care practitioners on the latest diagnostic and treatment guidelines for seven common rheumatic diseases. The course structure involves a short lecture on each topic and workshops on arthrocentesis, joint injection and DXA interpretation. Participants evaluated their knowledge and educational experience before, during and after the course. Thirty-two primary care practitioners attended, who had a median of 13 (IQR 6.5, 20) years experience in their specialty. The median number of educational symposia attended in the previous 5 years was 10 (IQR-5, 22.5), with a median of 0 (IQR 0, 1) in rheumatology. All respondents agreed that the course format was appropriate. Numerical improvements were demonstrated in participant\\'s confidence in diagnosing and managing all seven common rheumatologic conditions, with statistically significant improvements (p < 0.05) in 11 of the 14 aspects assessed. The Rheumatology Toolbox is an effective educational method for disseminating current knowledge in rheumatology to primary care physicians and improved participant\\'s self-assessed competence in diagnosis and management of common rheumatic diseases.

  16. Hot topics in modern rheumatology

    Directory of Open Access Journals (Sweden)

    D. E. Karateev

    2014-01-01

    Full Text Available The Expert Council for Tofacitinib (TOFA and two symposiums on New Possibilities for Targeted Therapy of Rheumatoid Arthritis and on Success Factor of Biological Therapy for Rheumatic Diseases were held within the annual scientific-and-practical conference of the V.A. Nasonova Research Institute of Rheumatology on Comorbidity in Rheumatic Diseases in Moscow on 14–15 October 2014.

  17. Bases and principles of rheumatology. Book

    International Nuclear Information System (INIS)

    Vidal, L.; Chavez, J.; Quevedo, H.; Castaneda, L.

    1993-01-01

    This book describes in 7 sections (42 chapters) the bases and principles of rheumatology. Section I bases and principles of rheumatology, Section II diffuse disorders of conjunctive tissue, Section III serum negatives spondyloarthropathies, Section IV arthropathies associated to infectious agents, Section V osteoarthritis diseases and different disorders, Section VI rational management rheumatic patients, Section VII therapeutics in rheumatology. In the chapter 34, the uses of radioisotope scanning in rheumatology are described. Every chapter contains also references, figures and tables

  18. Globalization of rheumatology: activities of ILAR. Think global - act local

    NARCIS (Netherlands)

    Dequeker, Jan; Rasker, Johannes J.; El-Hadidi, Tahsin

    2001-01-01

    In 1997 a distinguished EULAR rheumatologist involved in the development of biologics asked somewhat ironically, “What is ILAR [International League of Associations for Rheumatology] doing?” Now, 3 years later, we are in a position to review ILAR’s activities in recent years and its plans for the

  19. VACCINATION IN RHEUMATOLOGY: CURRENT ASPECTS

    Directory of Open Access Journals (Sweden)

    B. S. Belov

    2014-01-01

    Full Text Available Infectious diseases still remain a serious social and medical problem. The importance of comorbid infections in rheumatology has increased substantially in recent years, particularly due to the clinical introduction of biologicals. The investigation and active use of different vaccines are one of the ways to solve the above problem. This review considers the issues concerning the use of vaccines against influenza, infections caused by pneumococci, herpesviruses, human papillomavirus, and hepatitis B virus in rheumatology patients. It discusses the safety and immunogenicity of vaccination associated with the prevention of airway infections as the most common cause of a poor outcome in rheumatic diseases. The main areas of future investigations in the problem under consideration are defined.

  20. Update on rheumatology: part 1.

    Science.gov (United States)

    Neal-Boylan, Leslie

    2009-05-01

    There are many rheumatic diseases. Part 1 of this 2 part series on rheumatology presented a few of those most commonly seen in the community. Home health clinicians can be helpful in managing these diseases and preventing progression by watching for new symptoms or acute attacks of pain or disability, ensuring that patients take their medications appropriately, reminding patients to see their rheumatology providers and have their lab work done regularly, and reporting adverse effects to medications promptly. Additionally, as with most home health patients, an interdisciplinary approach that includes physical and occupational therapy, social work, nursing, nutrition, and other disciplines as needed should be implemented so that all patient needs are met and the patient is discharged at the highest level of self-care that is possible. Part 2 of this series will discuss the care of the patient with rheumatic disease at home and will provide a more in-depth look at lab diagnosis of rheumatic diseases.

  1. Performance of the 2012 Systemic Lupus International Collaborating Clinics classification criteria versus the 1997 American College of Rheumatology classification criteria in adult and juvenile systemic lupus erythematosus. A systematic review and meta-analysis.

    Science.gov (United States)

    Hartman, Esther A R; van Royen-Kerkhof, Annet; Jacobs, Johannes W G; Welsing, Paco M J; Fritsch-Stork, Ruth D E

    2018-03-01

    To evaluate the performance in classifying systemic lupus erythematosus by the 2012 Systemic Lupus International Collaborating Clinics criteria (SLICC'12), versus the revised American College of Rheumatology criteria from 1997 (ACR'97) in adult and juvenile SLE patients. A systematic literature search was conducted in PubMed and Embase for studies comparing SLICC'12 and ACR'97 with clinical diagnosis. A meta-analysis was performed to estimate the sensitivity and specificity of SLICC'12 and ACR'97. To assess classification earlier in the disease by either set, sensitivity and specificity were compared for patients with disease duration <5years. Sensitivity and specificity of individual criteria items were also assessed. In adult SLE (nine studies: 5236 patients, 1313 controls), SLICC'12 has higher sensitivity (94.6% vs. 89.6%) and similar specificity (95.5% vs. 98.1%) compared to ACR'97. For juvenile SLE (four studies: 568 patients, 339 controls), SLICC'12 demonstrates higher sensitivity (99.9% vs. 84.3%) than ACR'97, but much lower specificity (82.0% vs. 94.1%). SLICC'12 classifies juvenile SLE patients earlier in disease course. Individual items contributing to diagnostic accuracy are low complement, anti-ds DNA and acute cutaneous lupus in SLICC'12, and the immunologic and hematologic disorder in ACR'97. Based on sensitivity and specificity SLICC'12 is best for adult SLE. Following the view that higher specificity, i.e. avoidance of false positives, is preferable, ACR'97 is best for juvenile SLE even if associated with lower sensitivity. Our results on the contribution of the individual items of SLICC'12 and ACR´97 may be of value in future efforts to update classification criteria. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

  2. Pharmacology of biosimilar candidate drugs in rheumatology: a literature review.

    Science.gov (United States)

    Araújo, F; Cordeiro, I; Teixeira, F; Gonçalves, J; Fonseca, J E

    2014-01-01

    To review current evidence concerning pharmacology of biosimilar candidates to be used in rheumatology. A PubMed search up to August 2013 was performed using relevant search terms to include all studies assessing pharmacological properties of biosimilar candidates to be used in rheumatology. Data on study characteristics, type of intervention, pharmacokinetics (PK), pharmacodynamics (PD) and bioequivalence ratios was extracted. Of 280 articles screened, 5 fulfilled our inclusion criteria. Two trials, PLANETAS and PLANETRA, compared CT-P13 and infliximab in patients with active ankylosing spondylitis and rheumatoid arthritis, respectively. PK bioequivalence was demonstrated in the phase 1 PLANETAS trial by highly comparable area under the curve (AUC) and maximum drug concentrations (Cmax), whose geometric mean ratios fell between the accepted bioequivalence range of 80-125%. Equivalence in efficacy and safety was demonstrated in the phase 3 PLANETRA trial. Two phase 1 trials comparing etanercept biosimilar candidates TuNEX and HD203 in healthy volunteers showed a high degree of similarity in AUC and Cmax, with respective geometric mean ratios between PK bioequivalence range. The last included trial referred to GP2013, a rituximab biosimilar candidate, which demonstrated PK and PD bioequivalence to reference product in three different dosing regimens in cynomolgus monkeys. Infliximab, etanercept and rituximab biosimilar candidates have demonstrated PK bioequivalence in the trials included in this review. CT-P13 has recently been approved for use in the European market and the remaining biosimilar candidates are currently being tested in patients with rheumatoid arthritis.

  3. Rheumatology outpatient nurse clinics: a valuable addition?

    NARCIS (Netherlands)

    Temmink, D.; Hutten, J.B.F.; Francke, A.L.; Rasker, J.J.; Huijer Abu-Saad, H.; Zee, J. van der

    2001-01-01

    Objectives: "Transmural rheumatology nurse clinics," where nursing care is provided under the joint responsibility of a home care organization and a hospital, were recently introduced into Dutch health care. This article gives insight into outcomes of the transmural rheumatology nurse clinics.

  4. Rheumatology outpatient nurse clinics: a valuable addition?

    NARCIS (Netherlands)

    Temmink, Denise; Hutten, Jack B.F.; Francke, Anneke L.; Rasker, Johannes J.; Abu-Saad, Huda Huijer

    2001-01-01

    Objectives: Transmural rheumatology nurse clinics, where nursing care is provided under the joint responsibility of a home care organization and a hospital, were recently introduced into Dutch health care. This article gives insight into outcomes of the transmural rheumatology nurse clinics. -

  5. Musculoskeletal ultrasound in pediatric rheumatology

    Directory of Open Access Journals (Sweden)

    Özçakar Levent

    2011-09-01

    Full Text Available Abstract Although musculoskeletal ultrasound (MSUS has emerged as an indispensible tool among physicians involved in musculoskeletal medicine in the last two decades, only recently has it become more attractive to pediatric rheumatologists. Thereafter, the use of MSUS in pediatric rheumatology has started to increase. Yet, an ever-growing body of literature shows parity and even superiority of MSUS when compared to physical examination and other imaging modalities. MSUS is suitable for examination of children of all ages and it has certain advantages over other imaging modalities; as it is cheaper, mobile, instantly accessible bedside, easy to combine with clinical assessment (interactivity and non-invasive. It does not require sedation, which facilitates repetitive examinations. Assessment of multiple locations is possible during the same session. Agitation is rarely a problem and small children can be seated in their parents' lap or they can even play while being examined.

  6. Semiconductor lasers in rheumatological treatment

    Science.gov (United States)

    Pascu, Mihail-Lucian; Suteanu, S.; Ignat, P.; Pruna, Simion; Chitu, A.

    1995-03-01

    A computer controlled equipment, containing 6 lasers (HeNe and 5 diode lasers--DL) conceived to be used in rheumatological treatment is reported. DL emit at 895 nm and for typical applications, their expanded spots are superposed within the irradiation plane, on the HeNE defocused spot used to define the surface to be irradiated. DL emit 100 nsec pulses between 0.5 KHz and 1.5 KHz repetition rate and 0.5 mW average power (measured at 1 KHz). 150 patients with rheumathologic diseases were treated: lumbar spondylosis (75), gonarthrosis (30), cervical spondylosis (21), coxarthrosis (15), Heberden and Bouchard (9). The treatment consisted of: group I, 50 patients--laser therapy, 10 min/day, 10 days; group II, 50 patients--classical antirheumatic treatment; group III, 50 patients--mixed treatment. Assessment of sympathetic skin activity made using reactometry measurements, shows that latency time was longer before irradiation, 1867 +/- 289) msec then after, (1234 +/- 321) msec. Pain rating indexes decreasing for all three groups of patients were measured. Better results for more superficial diseases were obtained and best results were observed after irradiation with 1 KHz - 1.5 KHz repetition rate IR pulses. Better results were obtained when spot irradiation in a few points combined with zone irradiations was used.

  7. 2016 Classification criteria for macrophage activation syndrome complicating systemic juvenile idiopathic arthritis : A European league against Rheumatism/American college of Rheumatology/Paediatric rheumatology international trials organisation collaborative initiative

    NARCIS (Netherlands)

    Ravelli, Angelo; Minoia, Francesca; Davì, Sergio; Horne, Anna Carin; Bovis, Francesca; Pistorio, Angela; Aricò, Maurizio; Avcin, Tadej; Behrens, Edward M.; De Benedetti, Fabrizio; Filipovic, Lisa; Grom, Alexei A.; Henter, Jan Inge; Ilowite, Norman T.; Jordan, Michael B.; Khubchandani, Raju; Kitoh, Toshiyuki; Lehmberg, Kai; Lovell, Daniel J.; Miettunen, Paivi; Nichols, Kim E.; Ozen, Seza; Schmid, Jana Pachlopnik; Ramanan, Athimalaipet V.; Russo, Ricardo; Schneider, Rayfel; Sterba, Gary; Uziel, Yosef; Wallace, Carol; Wouters, Carine; Wulffraat, Nico; Demirkaya, Erkan; Brunner, Hermine I.; Martini, Alberto; Ruperto, Nicolino; Cron, Randy Q.

    2016-01-01

    To develop criteria for the classification of macrophage activation syndrome (MAS) in patients with systemic juvenile idiopathic arthritis (JIA). A multistep process, based on a combination of expert consensus and analysis of real patient data, was conducted. A panel of 28 experts was first asked to

  8. A brief history of ultrasound in rheumatology

    DEFF Research Database (Denmark)

    D'Agostino, Maria Antonietta; Terslev, Lene

    2014-01-01

    Musculoskeletal ultrasound is an evolving technique widely used in rheumatology thanks to the numerous advances and the improved work on standardisation. This article deals with the new developments in terms of technology and validation.......Musculoskeletal ultrasound is an evolving technique widely used in rheumatology thanks to the numerous advances and the improved work on standardisation. This article deals with the new developments in terms of technology and validation....

  9. Research priorities in pediatric rheumatology: The Childhood Arthritis and Rheumatology Research Alliance (CARRA consensus

    Directory of Open Access Journals (Sweden)

    Mellins Elizabeth D

    2008-04-01

    Full Text Available Abstract Background North American pediatric rheumatologists have created an investigator-initiated research network (the Childhood Arthritis and Rheumatology Research Alliance – CARRA to facilitate multi-centre studies. One of the first projects undertaken by this network was to define, by consensus, research priorities for the group, and if possible a first group-sponsored clinical trial in which all members could participate. Methods We determined consensus using the Delphi approach. This approach has been used extensively in health research to reach consensus in large groups. It uses several successive iterations of surveys eliciting ideas and opinions from specialists in the field. Three surveys were designed based on this method and were distributed to members of CARRA to elicit and rank-order research priorities. Results A response rate of 87.6% was achieved in the final survey. The most highly ranked research suggestion was to study infliximab treatment of uveitis unresponsive to methotrexate. Other highly ranked suggestions were to study i the treatment of systemic arthritis with anakinra and ii the treatment of pediatric systemic lupus erythematosus with mycophenolate mofetil. Conclusion The Delphi approach was an effective and practical method to define research priorities in this group. Ongoing discussion and cooperation among pediatric rheumatologists in CARRA and others world-wide will help in developing further research priorities and to facilitate the execution of clinical trials in the future.

  10. Type 1 Diabetes TrialNet--an international collaborative clinical trials network.

    Science.gov (United States)

    Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa

    2008-12-01

    Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.

  11. Including health equity considerations in development of instruments for rheumatology research

    DEFF Research Database (Denmark)

    O'Neill, Jennifer; Rader, Tamara; Guillemin, Francis

    2014-01-01

    The Outcome Measures in Rheumatology (OMERACT) Equity Special Interest Group (SIG) was established in 2008 to create a preliminary core set of outcome measures for clinical trials that can assess equity gaps in healthcare and the effectiveness of interventions to close or narrow gaps between...

  12. Rheumatology training in Poland vs. United Kingdom

    Directory of Open Access Journals (Sweden)

    Karina Lazarewicz

    2017-07-01

    Full Text Available When evaluating the quality of Rheumatology specialty training, it can be useful to explore similarities and differences between countries. In this article we compare the training in the UK and Poland. The two training programmes are similar in length and in the competencies that must be achieved, although they do have significant differences in the way the training is structured. The UK-based system is more out-patient based, which can be advantageous, as after completion of training the doctor is more confident in treating common rheumatological problems. On the other hand, having exposure to paediatric rheumatology and orthopaedics like one has in Polish-based training, despite a short placement time, is definitely beneficial for the trainee in gaining all-round knowledge. In conclusion, each system has its merits and can be further enhanced by observing how junior doctors are sub-speciality trained in different countries.

  13. An insight into rheumatology in Thailand.

    Science.gov (United States)

    Louthrenoo, Worawit

    2015-01-01

    Despite the fact that rheumatic diseases constitute a common health care problem in Thailand, improvements in rheumatology education, research and health care are still required. Low numbers of rheumatologists, their uneven distribution, lack of time to perform both clinical and basic research, lack of patient compliance and restricted access to effective medication comprise some of the barriers that need to be overcome to establish rheumatology education, research and care with a Western-country benchmark. The annual academic activities provided by the Thai Rheumatism Association for rheumatologists, general practitioners, allied health professionals and patients can advance only some forms of education and health care. Better cooperation between the Thai Rheumatism Association, the Royal College of Physicians of Thailand, the Ministry of Public Health and the Thai government is needed to improve rheumatology training, care and research in the country.

  14. Juvenile Idiopathic Arthritis in the Era of International Cooperation.

    Science.gov (United States)

    Uziel, Yosef

    2017-01-30

    Juvenile idiopathic arthritis (JIA) is the most common chronic disease of childhood. Improved understanding of its pathogenesis has led to international cooperation in clinical studies. Multicenter, international collaborations and research facilitate rapid enrollment of enough patients to enable a variety of studies, including those of epidemiology, diagnostic and classification criteria, genetic disease predisposition, pathogenesis, outcomes, and treatment protocols. In the last 20 years, the vision of the Pediatric Rheumatology International Trial Organization (PRINTO) has become a reality of worldwide collaboration in pediatric rheumatology research, including North American and European research groups. Major advances have been made in treating systemic JIA and its main complication, macrophage-activating syndrome (MAS). Single Hub and Access Point to Pediatric Rheumatology in Europe (SHARE) is a project of the European Society of Pediatric Rheumatology with the goal of improving clinical care. Based on evidence in the scientific literature, position papers regarding optimal clinical approaches and care have been published. Formal, validated assessment tools to evaluate response to treatment have been developed. Recommendations have been established to encourage international research collaborations, especially in light of major advances achieved in the genetics of pediatric rheumatologic diseases and the need to share biological samples among different countries and continents. Every participating country has disease information available for patients and families. Additionally, educational programs and updated syllabi for pediatric rheumatology have been written to promote similar, high-level academic training in different countries. These efforts have resulted in significant improvements in treatment and in patient prognosis. However, improved cooperation is needed to enhance research with biological and genetic samples. The Israeli Research Group for

  15. Ananyeva Rational antibiotic use in rheumatology

    Directory of Open Access Journals (Sweden)

    Boris Sergeyevich Belov

    2012-06-01

    Full Text Available To control infections and infectious complications is one of the most urgent challenges in medicine under present-day conditions. At the same time, rational therapy with anti-infective drugs occupies a highly importance place. In rheumatology, the necessity of using antibiotics is associated with at least two factors, such as eradication of a pathogen trigger (an infectious agent that triggers the immunopathological mechanisms of inflammation and treatment of comorbid infection. The paper gives information on etiological agents and detailed antimicrobial therapy regimens for the major infections observed in modern rheumatology.

  16. Ananyeva Rational antibiotic use in rheumatology

    Directory of Open Access Journals (Sweden)

    Boris Sergeyevich Belov

    2012-01-01

    Full Text Available To control infections and infectious complications is one of the most urgent challenges in medicine under present-day conditions. At the same time, rational therapy with anti-infective drugs occupies a highly importance place. In rheumatology, the necessity of using antibiotics is associated with at least two factors, such as eradication of a pathogen trigger (an infectious agent that triggers the immunopathological mechanisms of inflammation and treatment of comorbid infection. The paper gives information on etiological agents and detailed antimicrobial therapy regimens for the major infections observed in modern rheumatology.

  17. The patient's role in rheumatology care.

    Science.gov (United States)

    Brady, T J

    1998-03-01

    This article reviews narrative and empiric studies in rheumatology and related literature to explicate the patient's role in rheumatology care. In contrast to early conceptualizations, such as Parsons' sick role that emphasized compliance, current literature describes chronic disease patients as active participants in their care, rather than passive recipients of care. Active patients roles include participant in shared decision making, self-manager, and help and information seeker. All of these roles are colored by the individual's need to preserve a personally defined acceptable lifestyle. Suggestions for strategies that physicians and health professionals can use to engage and support these essential patient roles are also reviewed.

  18. [Complicated gastroduodenal ulcers in rheumatology patients].

    Science.gov (United States)

    Barashkov, V G; Shemerovskaia, T G; Sergeev, P V; Bokovanov, V E

    1998-01-01

    An analysis of observations of 250 patients with different rheumatological diseases has shown that 18% of the patients had ulcer disease with complications. The greatest risk of bleedings and perforations took place during the first year of treatment with nonsteroidal antiinflammatory drugs. The main risk factors of complications were determined. They are: male sex, high parameters of gastric secretion.

  19. Max Hirsch (1875-1941): His forgotten fate and his contributions to the founding of modern rheumatology.

    Science.gov (United States)

    Keitel, Wolfgang; Olsson, Leif; Matteson, Eric L

    2016-09-01

    To elucidate the connections between balneology and rheumatology in the founding period of the discipline of rheumatology, and describe the contributions of Max Hirsch, MD in the formation of professional rheumatology societies. Historical documents from the medical history collection of Vogelsang-Gommern, Germany, and original personal documents of the Hirsch family and information from the medical and historical period literature were used in developing this report. The first efforts at organizing rheumatology as a recognized clinical and academic discipline took place in the 1920s. Many of the first proponents were balneologists who cared for patients with chronic arthritic conditions without the benefit of effective medications. Max Hirsch, MD was a major figure in the development of modern rheumatology as it emerged from the provenance of balneology and orthopedics as a recognized organized medical discipline, contributing to the founding of the German Society for Rheumatology and the International League Against Rheumatism. Max Hirsch made significant contributions to scientific and organized rheumatology in the early days of the discipline. His contributions to the field and his fate as a Jewish physician have only recently come to light.

  20. Improved training of house officers in a rheumatology consult service.

    Science.gov (United States)

    Mazzuca, S A; Brandt, K D; Katz, B P

    1993-06-01

    This study examined whether the clinical environment could be used to increase internal medicine house officers' adoption of care recommendations taught in a didactic conference. Subjects were 11 internal medicine house officers who served 6-week rheumatology elective rotations. At the start of each of four rotation periods, house officers attended a 1-hour conference in which periarticular rheumatic disorders associated with knee pain (anserine bursitis, pseudothrombophlebitis) and shoulder pain (bicipital tendinitis) were discussed. All house officers also practiced physical examination techniques on anatomic models simulating the disorders. During alternate rotation periods, reminder sheets were appended to the records of arthritis patients with histories of chronic knee or shoulder pain. The frequency with which house officers followed conference recommendations was documented by direct observation (6 house officers in 17 encounters with reminders, 5 house officers in 30 encounters without reminders). Specific questioning about a recent history of knee or shoulder pain and the performance of four of five recommended physical examination maneuvers were increased significantly by reminder sheets in patients' charts (P < 0.05 for all). Although rheumatology faculty often have limited options available to increase the number of house officer trainees or to intensify clinical activity, qualitative improvements within existing logistic parameters are feasible by assuring that the clinical environment (e.g., patient records) contains salient cues that will prompt desired actions.

  1. Characterizing the concept of activity pacing as a non-pharmacological intervention in rheumatology care

    DEFF Research Database (Denmark)

    Cuperus, N; Vliet Vlieland, Tpm; Brodin, N

    2016-01-01

    OBJECTIVE: To develop a consensual list of the most important aspects of activity pacing (AP) as an intervention within the context of non-pharmacological rheumatology care. METHOD: An international, multidisciplinary expert panel comprising 60 clinicians and/or healthcare providers experienced i...

  2. Enhancing the reporting and transparency of rheumatology research

    DEFF Research Database (Denmark)

    Christensen, Robin; Bliddal, Henning; Henriksen, Marius

    2013-01-01

    Manuscripts and abstracts from biomedical journals frequently do not contain proper information for meeting required standards and serving the multiple needs of their end users. Reporting guidelines and checklists help researchers to meet those standards by providing rules or principles......, to present a structured overview of reporting guidelines that rheumatology journals could apply, and to encourage their use by journal authors, editors, and reviewers, including those of Arthritis Research & Therapy. Internationally recognized reporting guidelines exist for a diversity of research areas. We...... encourage colleagues to consult the 'Enhancing the QUAlity and Transparency Of health Research' (EQUATOR) network when writing scientific papers. EQUATOR is an international initiative that seeks to improve the reliability and value of biomedical research literature by promoting transparent and accurate...

  3. INTRAVENOUS IMMUNOGLOBULIN IN PEDIATRIC RHEUMATOLOGY PRACTICE

    Directory of Open Access Journals (Sweden)

    E. I. Alexeeva

    2015-01-01

    Full Text Available Modern successful treatment of rheumatic diseases is impossible without the use of intravenous immunoglobulin. The use of intravenous immunoglobulin is based on strict indications developed as a result of long-term multicenter controlled studies. The article highlights the issues of using immunoglobulin in pediatric rheumatology practice, and provides the review of literature with the results from the evaluation of the efficiency of intravenous immunoglobulin confirming the efficiency of the drug only for certain rheumatic diseases. 

  4. Gout treatment: survey of Brazilian rheumatology residents.

    Science.gov (United States)

    Amorim, Rodrigo Balbino Chaves; Vargas-Santos, Ana Beatriz; Pereira, Leticia Rocha; Coutinho, Evandro Silva Freire; da Rocha Castelar-Pinheiro, Geraldo

    2017-05-01

    To assess the current practices in gout management among Brazilian rheumatology residents. We performed a cross-sectional online survey among all the rheumatology residents and those rheumatologists who had just completed their training (post-residency (PR)) regarding their approach to gout management. Results were compared with the 2012 American College of Rheumatology (ACR) gout guidelines and with the responses of a previous survey with a representative sample of practicing Brazilian rheumatologists (RHE). We received 224 responses (83%) from 271 subjects. Among all respondents, the first-choice treatment for gout flares was the combination of a nonsteroidal anti-inflammatory drug + colchicine for otherwise healthy patients. A target serum urate 75%. Less than 70% reported starting allopurinol at low doses (≤100 mg/day) for patients with normal renal function and gout guidelines, especially among PR. However, some important aspects of gout management need improvement. These results will guide the development of a physician education program to improve the management of gout patients in Brazil.

  5. Research ethics board approval for an international thromboprophylaxis trial.

    Science.gov (United States)

    Lutz, Kristina; Wilton, Kelly; Zytaruk, Nicole; Julien, Lisa; Hall, Richard; Harvey, Johanne; Skrobik, Yoanna; Vlahakis, Nicholas; Meade, Laurie; Matte, Andrea; Meade, Maureen; Burns, Karen; Albert, Martin; Cash, Bronwyn Barlow; Vallance, Shirley; Klinger, James; Heels-Ansdell, Diane; Cook, Deborah

    2012-06-01

    Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial. We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF). Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77% completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54% of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits. More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards. Copyright © 2012 Elsevier Inc. All rights reserved.

  6. Rheumatologic services in Central Asian countries: current state of development of rheumatology in Central Asia.

    Science.gov (United States)

    Omurzakova, Nazgul A; Yamano, Yoshihisa; Saatova, Guli M; Shukurova, Surayo M; Mirzakhanova, Mavliuda I; Kydyralieva, Ryskul B; Jumagulova, Aynagul S; Mirrakhimov, Erkin M; Seisenbaev, Askar Sh; Nishioka, Kusuki; Nakajima, Toshihiro

    2009-12-01

    Rheumatologic and public health services of Central Asia's republics have suffered hugely as a result of social and economic declines following the dissolution of the Union of Soviet Socialist Republics (USSR) and transition of these republics to market economies. Between 1990 and 2000 there was a mass outflow of highly skilled rheumatologists and teachers and researchers in rheumatology to countries abroad, leading to significant deprivation of rheumatological service in Central Asian countries. During this time, there was continued growth of various rheumatic diseases (RDs) including rheumatic fever, and musculoskeletal and connective tissue disorders. The medical and social burden of RDs imposed on society was strongly underestimated until recent times. There is an urgent need to define the epidemiology of RDs and their impact on the quality of life of people afflicted by these conditions, and to improve the diagnostics and treatment of these conditions.

  7. Digital health: a new dimension in rheumatology patient care.

    Science.gov (United States)

    Kataria, Suchitra; Ravindran, Vinod

    2018-04-30

    The new digital health innovations have opened up several opportunities to help the clinicians, patients and other caregivers of rheumatology healthcare system in maximizing efficiencies resulting in better patient outcomes. In the global context, digital health technology has the potential to bridge the distance gap between all the key stakeholders involved in rheumatology health care. In this review, we update on the recent advances in the field of digital health and highlight unique features of these technologies which would help in routine care. Application of technology in any form to enable, facilitate or enhance the quality of care is the foundation of digitised care. The components could be smartphone apps, sensors, video, social media platforms or messenger platforms, wearables or a combination of these enabling healthcare delivery and overcoming the constraints of distance, location and time. Digital therapeutics have started evolving and an important step in this direction is the involvement of FDA in the approval process. Speciality specific apps, personalised patient education as per disease status, remote specialist consultations or virtual health coach to guide on lifestyle modifications are some of the developments which have been facilitated by increased digitization in all walks of life. Assisted care with the help of robots rendering care in the hospitals or an intelligent robot guiding a patient by voice and visual sense at home are already at the threshold of entering the mainstream of patient care. Wearable devices equipped with powerful sensors are coming handy in keeping a watch on patient symptoms all the time and providing useful insights on disease progression, clinical response or complications. In chronic care such as rheumatology the implications, possibilities and benefits seem unprecedented. Real time data analytics and artificial intelligence are helping the clinicians, healthcare systems and policy makers optimise the resources and

  8. Clinical Trials in Dentistry: A Cross-sectional Analysis of World Health Organization-International Clinical Trial Registry Platform.

    Science.gov (United States)

    Sivaramakrishnan, Gowri; Sridharan, Kannan

    2016-06-01

    Clinical trials are the back bone for evidence-based practice (EBP) and recently EBP has been considered the best source of treatment strategies available. Clinical trial registries serve as databases of clinical trials. As regards to dentistry in specific data on the number of clinical trials and their quality is lacking. Hence, the present study was envisaged. Clinical trials registered in WHO-ICTRP (http://apps.who.int/trialsearch/AdvSearch.aspx) in dental specialties were considered. The details assessed from the collected trials include: Type of sponsors; Health condition; Recruitment status; Study design; randomization, method of randomization and allocation concealment; Single or multi-centric; Retrospective or prospective registration; and Publication status in case of completed studies. A total of 197 trials were identified. Maximum trials were from United States (n = 30) and United Kingdom (n = 38). Seventy six trials were registered in Clinical Trials.gov, 54 from International Standards of Reporting Clinical Trials, 13 each from Australia and New Zealand Trial Register and Iranian Registry of Clinical Trials, 10 from German Clinical Trial Registry, eight each from Brazilian Clinical Trial Registry and Nederland's Trial Register, seven from Japan Clinical Trial Registry, six from Clinical Trial Registry of India and two from Hong Kong Clinical Trial Registry. A total of 78.7% studies were investigator-initiated and 64% were completed while 3% were terminated. Nearly four-fifths of the registered trials (81.7%) were interventional studies of which randomized were the large majority (94.4%) with 63.2% being open label, 20.4% using single blinding technique and 16.4% were doubled blinded. The number, methodology and the characteristics of clinical trials in dentistry have been noted to be poor especially in terms of being conducted multi-centrically, employing blinding and the method for randomization and allocation concealment. More emphasis has to be

  9. Rheumatology Research Foundation Clinician Scholar Educator Award: Fifteen Years Promoting Rheumatology Educators and Education.

    Science.gov (United States)

    Berman, Jessica R; O'Rourke, Kenneth S; Kolasinski, Sharon L; Aizer, Juliet; Wheatley, Mary J; Battistone, Michael J; Siaton, Bernadette C; Criscione-Schreiber, Lisa; Pillinger, Michael H; Lazaro, Deana M

    2016-11-01

    The Rheumatology Research Foundation's Clinician Scholar Educator (CSE) award is a 3-year career development award supporting medical education research while providing opportunities for mentorship and collaboration. Our objective was to document the individual and institutional impact of the award since its inception, as well as its promise to strengthen the subspecialty of rheumatology. All 60 CSE Award recipients were surveyed periodically. Fifty-six of those 60 awardees (90%) responded to requests for survey information that included post-award activities, promotions, and further funding. Data were also collected from yearly written progress reports for each grant. Of the total CSE recipients to date, 48 of 60 (80%) are adult rheumatologists, 11 of 60 (18%) are pediatric rheumatologists, and 1 is an adult and pediatric rheumatologist. Two-thirds of survey respondents spend up to 30% of their total time in educational activities, and one-third spend greater than 30%. Thirty-one of the 60 CSE recipients (52%) have published a total of 86 medical education papers. Twenty-six of 52 (50%) had received an academic promotion following the award. Eleven awardees earned advanced degrees. We describe the creation and evolution of a grant program from a medical subspecialty society foundation and the impact on producing education research, individual identity formation, and ongoing support for educators. This community of rheumatology scholar educators now serves as an important resource at the national level for the American College of Rheumatology and its membership. We believe that this grant may serve as a model for other medical societies that want to promote education scholarship and leadership within their specialties. © 2016, American College of Rheumatology.

  10. American College of Rheumatology provisional criteria for defining clinical inactive disease in select categories of juvenile idiopathic arthritis.

    Science.gov (United States)

    Wallace, Carol A; Giannini, Edward H; Huang, Bin; Itert, Lukasz; Ruperto, Nicolino

    2011-07-01

    To prospectively validate the preliminary criteria for clinical inactive disease (CID) in patients with select categories of juvenile idiopathic arthritis (JIA). We used the process for development of classification and response criteria recommended by the American College of Rheumatology Quality of Care Committee. Patient-visit profiles were extracted from the phase III randomized controlled trial of infliximab in polyarticular-course JIA (i.e., patients considered to resemble those with select categories of JIA) and sent to an international group of expert physician raters. Using the physician ratings as the gold standard, the sensitivity and specificity were calculated using the preliminary criteria. Modifications to the criteria were made, and these were sent to a larger group of pediatric rheumatologists to determine quantitative, face, and content validity. Variables weighted heaviest by physicians when making their judgment were the number of joints with active arthritis, erythrocyte sedimentation rate (ESR), physician's global assessment, and duration of morning stiffness. Three modifications were made: the definition of uveitis, the definition of abnormal ESR, and the addition of morning stiffness. These changes did not alter the accuracy of the preliminary set. The modified criteria, termed the "criteria for CID in select categories of JIA," have excellent feasibility and face, content, criterion, and discriminant validity to detect CID in select categories of JIA. The small changes made to the preliminary criteria set did not alter the area under the receiver operating characteristic curve (0.954) or accuracy (91%), but have increased face and content validity. Copyright © 2011 by the American College of Rheumatology.

  11. The 2017 EULAR standardised procedures for ultrasound imaging in rheumatology

    DEFF Research Database (Denmark)

    Möller, Ingrid; Janta, Iustina; Backhaus, Marina

    2017-01-01

    of MSUS evaluable structures; (2) a Delphi survey among rheumatologist and radiologist experts in MSUS to select MS and non-MS anatomic structures evaluable by US that are relevant to rheumatology, to select abnormalities evaluable by US and to prioritise these pathologies for rheumatology and (3...

  12. Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials.

    Science.gov (United States)

    Larson, Gregg S; Carey, Cate; Grarup, Jesper; Hudson, Fleur; Sachi, Karen; Vjecha, Michael J; Gordin, Fred

    2016-04-01

    Randomized clinical trials are widely recognized as essential to address worldwide clinical and public health research questions. However, their size and duration can overwhelm available public and private resources. To remain competitive in international research settings, advocates and practitioners of clinical trials must implement practices that reduce their cost. We identify approaches and practices for large, publicly funded, international trials that reduce cost without compromising data integrity and recommend an approach to cost reporting that permits comparison of clinical trials. We describe the organizational and financial characteristics of The International Network for Strategic Initiatives in Global HIV Trials, an infectious disease research network that conducts multiple, large, long-term, international trials, and examine challenges associated with simple and streamlined governance and an infrastructure and financial management model that is based on performance, transparency, and accountability. It is possible to reduce costs of participants' follow-up and not compromise clinical trial quality or integrity. The International Network for Strategic Initiatives in Global HIV Trials network has successfully completed three large HIV trials using cost-efficient practices that have not adversely affected investigator enthusiasm, accrual rates, loss-to-follow-up, adherence to the protocol, and completion of data collection. This experience is relevant to the conduct of large, publicly funded trials in other disease areas, particularly trials dependent on international collaborations. New approaches, or creative adaption of traditional clinical trial infrastructure and financial management tools, can render large, international clinical trials more cost-efficient by emphasizing structural simplicity, minimal up-front costs, payments for performance, and uniform algorithms and fees-for-service, irrespective of location. However, challenges remain. They

  13. The uptake of influenza and pneumococcal vaccination among immunocompromised patients attending rheumatology outpatient clinics.

    LENUS (Irish Health Repository)

    Haroon, Muhammad

    2011-07-01

    PURPOSE AND OBJECTIVES: The patients using immunosuppressive agents are considered at high risk for acquiring different infections. Accordingly, international guidelines recommend vaccinating such patients against influenza and pneumococcal organisms. The aims of this study were two-fold: (1) to assess the influenza and pneumococcal vaccination uptake among our rheumatology outpatients who are immunosuppressed; (2) to identify the factors influencing immunisation uptake among our sample of patients.

  14. The changing landscape of biosimilars in rheumatology

    Science.gov (United States)

    Dörner, Thomas; Strand, Vibeke; Cornes, Paul; Gonçalves, João; Gulácsi, László; Kvien, Tore K; Tanaka, Yoshiya; Burmester, Gerd R

    2016-01-01

    Biosimilars remain a hot topic in rheumatology, and some physicians are cautious about their application in the real world. With many products coming to market and a wealth of guidelines and recommendations concerning their use, there is a need to understand the changing landscape and the real clinical and health-economic potential offered by these agents. Notably, rheumatologists will be at the forefront of the use of biosimilar monoclonal antibodies/soluble receptors. Biosimilars offer cost savings and health gains for our patients and will play an important role in treating rheumatic diseases. We hope that these lower costs will compensate for inequities in access to therapy based on economic differences across countries. Since approved biosimilars have already demonstrated highly similar efficacy, it will be most important to establish pharmacovigilance databases across countries that are adequate to monitor long-term safety after marketing approval. PMID:26964144

  15. Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity

    Directory of Open Access Journals (Sweden)

    Birtwhistle Richard

    2003-12-01

    Full Text Available Abstract Background Controlled clinical trials of health care interventions are either explanatory or pragmatic. Explanatory trials test whether an intervention is efficacious; that is, whether it can have a beneficial effect in an ideal situation. Pragmatic trials measure effectiveness; they measure the degree of beneficial effect in real clinical practice. In pragmatic trials, a balance between external validity (generalizability of the results and internal validity (reliability or accuracy of the results needs to be achieved. The explanatory trial seeks to maximize the internal validity by assuring rigorous control of all variables other than the intervention. The pragmatic trial seeks to maximize external validity to ensure that the results can be generalized. However the danger of pragmatic trials is that internal validity may be overly compromised in the effort to ensure generalizability. We are conducting two pragmatic randomized controlled trials on interventions in the management of hypertension in primary care. We describe the design of the trials and the steps taken to deal with the competing demands of external and internal validity. Discussion External validity is maximized by having few exclusion criteria and by allowing flexibility in the interpretation of the intervention and in management decisions. Internal validity is maximized by decreasing contamination bias through cluster randomization, and decreasing observer and assessment bias, in these non-blinded trials, through baseline data collection prior to randomization, automating the outcomes assessment with 24 hour ambulatory blood pressure monitors, and blinding the data analysis. Summary Clinical trials conducted in community practices present investigators with difficult methodological choices related to maintaining a balance between internal validity (reliability of the results and external validity (generalizability. The attempt to achieve methodological purity can

  16. AUTOINFLAMMATORY DISEASES IN RHEUMATOLOGY: RUSSIAN EXPERIENCE

    Directory of Open Access Journals (Sweden)

    S. O. Salugina

    2016-01-01

    Full Text Available Autoinflammatory diseases (AIDs are characterized by periodic, sometimes self-limiting attacks that appear as fever and clinical symptoms resembling rheumatic ones, in the absence of autoimmune or infectious diseases. The group of AIDs encompasses a broad spectrum of nosological entities; some of them have been recently dealt with by rheumatologists.Objective: to define the spectrum of AIDs in the practice of a pediatric rheumatologist from the results of visits to the Russian Federal Rheumatology Center.Subjects and methods. The investigation enrolled patients who had visited the V.A. Nasonova Research Institute of Rheumatology in 2007 to 2015 for fever and other signs of a systemic inflammatory process in order to specify their diagnosis and to rule out infections, blood cancer, and other diseases. All underwent conventional rheumatologic examination, HLA Class A typing, and molecular genetic testing.Results and discussion. 101 patients aged 6.5 months to 60 years with AIDs were identified over 9 years and diagnosed as having the following diseases. Familial Mediterranean fever (FMF was detected in 17 patients (the female to male (M/F ratio was 6:11; Behсet's disease (BD in 25 children (M/F, 14:11, cryopyrin-associated periodic syndromes (CAPS in 17 patients, including Muckle–Wells syndrome in 13 (M/F, 4:9; chronic infantile neurologic cutaneous articular and neonatal onset multisystem inflammatory disease (CINCA/NOMID syndrome in 4 (M/F, 3:1, periodic fever, aphthous stomatitis, pharyngitis, cervical adenitis (PFAPA syndrome in 17 (M/F, 10:7, hyper-IgD syndrome/mevalonate kinase deficiency syndrome in 3 (M/F, 0:3, tumor necrosis factor receptor periodic syndrome (TRAPS in 7 (M/F, 4:3, undifferentiated AID in 14, and Blau syndrome in one patient. The patients with BD were rather ethnically diverse: among them, there were representatives of North Caucasian peoples, Tatars, Uzbeks, Moldavians, and others; there were 7 ethnic Russians. There

  17. [The informed consent in international clinical trials including developing countries].

    Science.gov (United States)

    Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine

    2008-01-01

    The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries. We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials. To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers. Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.

  18. 2015 American College of Rheumatology Workforce Study: Supply and Demand Projections of Adult Rheumatology Workforce, 2015-2030.

    Science.gov (United States)

    Battafarano, Daniel F; Ditmyer, Marcia; Bolster, Marcy B; Fitzgerald, John D; Deal, Chad; Bass, Ann R; Molina, Rodolfo; Erickson, Alan R; Hausmann, Jonathan S; Klein-Gitelman, Marisa; Imundo, Lisa F; Smith, Benjamin J; Jones, Karla; Greene, Kamilah; Monrad, Seetha U

    2018-04-01

    To describe the character and composition of the 2015 US adult rheumatology workforce, evaluate workforce trends, and project supply and demand for clinical rheumatology care for 2015-2030. The 2015 Workforce Study of Rheumatology Specialists in the US used primary and secondary data sources to estimate the baseline adult rheumatology workforce and determine demographic and geographic factors relevant to workforce modeling. Supply and demand was projected through 2030, utilizing data-driven estimations regarding the proportion and clinical full-time equivalent (FTE) of academic versus nonacademic practitioners. The 2015 adult workforce (physicians, nurse practitioners, and physician assistants) was estimated to be 6,013 providers (5,415 clinical FTE). At baseline, the estimated demand exceeded the supply of clinical FTE by 700 (12.9%). By 2030, the supply of rheumatology clinical providers is projected to fall to 4,882 providers, or 4,051 clinical FTE (a 25.2% decrease in supply from 2015 baseline levels). Demand in 2030 is projected to exceed supply by 4,133 clinical FTE (102%). The adult rheumatology workforce projections reflect a major demographic and geographic shift that will significantly impact the supply of the future workforce by 2030. These shifts include baby-boomer retirements, a millennial predominance, and an increase of female and part-time providers, in parallel with an increased demand for adult rheumatology care due to the growing and aging US population. Regional and innovative strategies will be necessary to manage access to care and reduce barriers to care for rheumatology patients. © 2018, American College of Rheumatology.

  19. Pediatric rheumatology: what does the future hold?

    Science.gov (United States)

    Emery, Helen

    2004-08-01

    Effectiveness of the traditional rehabilitation approaches used in pediatric rheumatology has been difficult to prove and, in times of cost containment, this lack of evidence may lead to undertreatment with physical and occupational therapies. Quantitative methods such as those described in this issue by Broström and colleagues can be used to validate those approaches and to reinforce the need for careful attention to the effects of even minor loss of range and strength in children with juvenile arthritis. Historically, up to half of the children affected by polyarticular juvenile arthritis became disabled. Some factors that have led to improved outcomes for childhood rheumatic diseases are discussed, including medications (use of weekly low-dose methotrexate, intra-articular steroid injections, new biologic agents that specifically block mediators of inflammation, for example, tumor necrosis factor and interleukin-1), surgery (joint replacements), and psychosocial interventions (with schools and families). The importance of maintaining range of movement, strength, weight bearing, and ambulation, in an effort to prevent sequelae such as osteoporosis and wheelchair dependence, is emphasized. Early identification of children with rheumatic diseases and aggressive intervention, with a combined medical, rehabilitation, psychosocial, and, rarely, surgical approach, should now allow most affected children to reach adulthood with little or no disability.

  20. Wars in the history of rheumatology

    Directory of Open Access Journals (Sweden)

    P. Marson

    2011-09-01

    Full Text Available Some important discoveries in the history of rheumatology happened during war periods. It is well known that arthritis associated with conjunctivitis and urethritis, following dysenteric episodes, has been described during the First World War from the German Hans Reiter and, nearly contemporarily, from the French Nöel Fiessinger and Edgar Leroy. Less known is instead the fact that the first cases of sympathetic algoneurodystrophy have been reported by the American Silas Weir Mitchell in soldiers wounded by fire-arms, during the Civil War of Secession. Other war episodes have been crucial for the development of some drugs now abundantly applied to the care of rheumatic diseases. The discovery of therapeutic effects of immunosuppressive agents, in fact, happened as an indirect consequence of the use of poison gas, already during the First World War (mustard gas, but above all after an episode in the port of Bari in 1943, where an American cargo boat was sunk. It had been loaded with a quantity of cylinders containing a nitrogenous mustard, whose diffusion in the environment provoked more than 80 deaths owing to bone marrow aplasia.Moreover, the history of the cortisone shows a strict link to the Second World War, when Germany imported large quantities of bovine adrenal glands from Argentina, with the purpose of producing some gland extracts for the Luftwasse aviators, in order to increase their performance ability.

  1. Update of the Mexican College of Rheumatology guidelines for the pharmacologic treatment of rheumatoid arthritis.

    Science.gov (United States)

    Cardiel, Mario H; Díaz-Borjón, Alejandro; Vázquez del Mercado Espinosa, Mónica; Gámez-Nava, Jorge Iván; Barile Fabris, Leonor A; Pacheco Tena, César; Silveira Torre, Luis H; Pascual Ramos, Virginia; Goycochea Robles, María Victoria; Aguilar Arreola, Jorge Enrique; González Díaz, Verónica; Alvarez Nemegyei, José; González-López, Laura del Carmen; Salazar Páramo, Mario; Portela Hernández, Margarita; Castro Colín, Zully; Xibillé Friedman, Daniel Xavier; Alvarez Hernández, Everardo; Casasola Vargas, Julio; Cortés Hernández, Miguel; Flores-Alvarado, Diana E; Martínez Martínez, Laura A; Vega-Morales, David; Flores-Suárez, Luis Felipe; Medrano Ramírez, Gabriel; Barrera Cruz, Antonio; García González, Adolfo; López López, Susana Marisela; Rosete Reyes, Alejandra; Espinosa Morales, Rolando

    2014-01-01

    The pharmacologic management of rheumatoid arthritis has progressed substantially over the past years. It is therefore desirable that existing information be periodically updated. There are several published international guidelines for the treatment of rheumatoid arthritis that hardly adapt to the Mexican health system because of its limited healthcare resources. Hence, it is imperative to unify the existing recommendations and to incorporate them to a set of clinical, updated recommendations; the Mexican College of Rheumatology developed these recommendations in order to offer an integral management approach of rheumatoid arthritis according to the resources of the Mexican health system. To review, update and improve the available evidence within clinical practice guidelines on the pharmacological management of rheumatoid arthritis and produce a set of recommendations adapted to the Mexican health system, according to evidence available through December 2012. The working group was composed of 30 trained and experienced rheumatologists with a high quality of clinical knowledge and judgment. Recommendations were based on the highest quality evidence from the previously established treatment guidelines, meta-analysis and controlled clinical trials for the adult population with rheumatoid arthritis. During the conformation of this document, each working group settled the existing evidence from the different topics according to their experience. Finally, all the evidence and decisions were unified into a single document, treatment algorithm and drug standardization tables. This update of the Mexican Guidelines for the Pharmacologic Treatment of Rheumatoid Arthritis provides the highest quality information available at the time the working group undertook this review and contextualizes its use for the complex Mexican health system. Copyright © 2013 Elsevier España, S.L. All rights reserved.

  2. Policy challenges for the pediatric rheumatology workforce: Part I. Education and economics

    Directory of Open Access Journals (Sweden)

    Henrickson Michael

    2011-08-01

    Full Text Available Abstract For children with rheumatic conditions, the available pediatric rheumatology workforce mitigates their access to care. While the subspecialty experiences steady growth, a critical workforce shortage constrains access. This three-part review proposes both national and international interim policy solutions for the multiple causes of the existing unacceptable shortfall. Part I explores the impact of current educational deficits and economic obstacles which constrain appropriate access to care. Proposed policy solutions follow each identified barrier. Challenges consequent to obsolete, limited or unavailable exposure to pediatric rheumatology include: absent or inadequate recognition or awareness of rheumatic disease; referral patterns that commonly foster delays in timely diagnosis; and primary care providers' inappropriate or outdated perception of outcomes. Varying models of pediatric rheumatology care delivery consequent to market competition, inadequate reimbursement and uneven institutional support serve as additional barriers to care. A large proportion of pediatrics residency programs offer pediatric rheumatology rotations. However, a minority of pediatrics residents participate. The current generalist pediatrician workforce has relatively poor musculoskeletal physical examination skills, lacking basic competency in musculoskeletal medicine. To compensate, many primary care providers rely on blood tests, generating referrals that divert scarce resources away from patients who merit accelerated access to care for rheumatic disease. Pediatric rheumatology exposure could be enhanced during residency by providing a mandatory musculoskeletal medicine rotation that includes related musculoskeletal subspecialties. An important step is the progressive improvement of many providers' fixed referral and laboratory testing patterns in lieu of sound physical examination skills. Changing demographics and persistent reimbursement disparities will

  3. Herpes zoster infection, vaccination and immunocompromised rheumatology patients.

    LENUS (Irish Health Repository)

    O'Connor, Mortimer B

    2013-01-01

    Varicella is a self-limiting and relatively mild disease of childhood, although it is frequently more severe and complicated among the immunocompromised rheumatology patients on immunomodulator therapies. In addition, future reactivation of the dormant virus in dorsal root ganglia may cause herpes zoster infection, which can be very debilitating. In this manuscript, we discuss the nature of this infection along with its potential vaccine especially among rheumatology patients.

  4. Paediatric rheumatology practice in the UK benchmarked against the British Society for Paediatric and Adolescent Rheumatology/Arthritis and Musculoskeletal Alliance Standards of Care for juvenile idiopathic arthritis.

    Science.gov (United States)

    Kavirayani, Akhila; Foster, Helen E

    2013-12-01

    To describe current clinical practice against the BSPAR/ARMA Standards of Care (SOCs) for children and young people (CYP) with incident JIA. Ten UK paediatric rheumatology centres (including all current centres nationally accredited for paediatric rheumatology higher specialist training) participated in a retrospective case notes review using a pretested pro forma based on the SOC. Data collected per centre included clinical service configuration and the initial clinical care for a minimum of 30 consecutive new patients seen within the previous 2 years and followed up for at least 6 months. A total of 428 CYP with JIA (median age 11 years, range 1-21 years) were included, with complete data available for 73% (311/428). Against the key SOCs, 41% (175/428) were assessed ≤10 weeks from symptom onset, 60% (186/311) ≤4 weeks from referral, 26% (81/311) had eye screening at ≤6 weeks, 83% (282/341) had joint injections at ≤6 weeks, 59% (184/311) were assessed by a nurse specialist at ≤4 weeks and 45% (141/311) were assessed by a physiotherapist at ≤8 weeks. A median of 6% of patients per centre participated in clinical trials. All centres had access to eye screening and prescribed biologic therapies. All had access to a nurse specialist and physiotherapist. Most had access to an occupational therapist (8/10), psychologist (8/10), joint injection lists (general anaesthesia/inhaled analgesia) (9/10) and designated transitional care clinics (7/10). This first description of UK clinical practice in paediatric rheumatology benchmarked against the BSPAR/ARMA SOCs demonstrates variable clinical service delivery. Considerable delay in access to specialist care is evident and this needs to be addressed in order to improve clinical outcomes.

  5. Pure analgesics in a rheumatological outpatient clinic

    Directory of Open Access Journals (Sweden)

    M.A. Cimmino

    2011-09-01

    Full Text Available Objective: Pure analgesics are only rarely used by Italian clinicians and this holds true also for rheumatologists. This work is concerned with an evaluation of the use of analgesics in a rheumatological outpatient clinic during the period 1989-1999. Methods: The records of 1705 patients consecutively seen at the clinic were downloaded on a specifically built website. Results: 4469 visits were considered. In 260 of them (5.8%, analgesics were prescribed to 234 (13.7% patients. The number of patients with a prescription of analgesics steadily increased during the years 1989-1999. The diagnoses in patients assuming analgesics were: osteoarthritis (47.1%, inflammatory arthritis (24.2%, soft tissue rheumatisms (13.7%, nonspecific arthralgia/myalgia (7.5%, and connective tissue diseases (2.6%. Peripheral analgesics were used in 188 (82.5% patients and central analgesics were used in the remaining 40 patients (17.5%. Analgesic drugs were used mainly in degenerative joint conditions. The indications for analgesics in the 55 patients with inflammatory arthrits were: (a partial or total remission of arthritis; for this reason non-steroidal anti-inflammatory drugs were no longer required in 18 patients; (b to increase the analgesic effect of NSAIDs in 23 patients; (c contraindications to NSAIDs in 14 patients (renal failure in 2 patients, gastritis in 10, allergy and bleeding in the remaining two. Conclusions: About 14% of our outpatients were treated with analgesics with an increasing trend in the examined period. The main indications for analgesics are degenerative conditions but they can be used also in selected patients with arthritis.

  6. The relationship between external and internal validity of randomized controlled trials: A sample of hypertension trials from China.

    Science.gov (United States)

    Zhang, Xin; Wu, Yuxia; Ren, Pengwei; Liu, Xueting; Kang, Deying

    2015-10-30

    To explore the relationship between the external validity and the internal validity of hypertension RCTs conducted in China. Comprehensive literature searches were performed in Medline, Embase, Cochrane Central Register of Controlled Trials (CCTR), CBMdisc (Chinese biomedical literature database), CNKI (China National Knowledge Infrastructure/China Academic Journals Full-text Database) and VIP (Chinese scientific journals database) as well as advanced search strategies were used to locate hypertension RCTs. The risk of bias in RCTs was assessed by a modified scale, Jadad scale respectively, and then studies with 3 or more grading scores were included for the purpose of evaluating of external validity. A data extract form including 4 domains and 25 items was used to explore relationship of the external validity and the internal validity. Statistic analyses were performed by using SPSS software, version 21.0 (SPSS, Chicago, IL). 226 hypertension RCTs were included for final analysis. RCTs conducted in university affiliated hospitals (P internal validity. Multi-center studies (median = 4.0, IQR = 2.0) were scored higher internal validity score than single-center studies (median = 3.0, IQR = 1.0) (P internal validity (P = 0.004). Multivariate regression indicated sample size, industry-funding, quality of life (QOL) taken as measure and the university affiliated hospital as trial setting had statistical significance (P external validity of RCTs do associate with the internal validity, that do not stand in an easy relationship to each other. Regarding the poor reporting, other possible links between two variables need to trace in the future methodological researches.

  7. Efficacy of an Interinstitutional Mentoring Program Within Pediatric Rheumatology.

    Science.gov (United States)

    Moorthy, Lakshmi Nandini; Muscal, Eyal; Riebschleger, Meredith; Klein-Gitelman, Marisa; Nigrovic, Lise E; Horon, Jeffrey R; Rouster-Stevens, Kelly; Ferguson, Polly J; Eberhard, B Anne; Brunner, Hermine I; Prahalad, Sampath; Schneider, Rayfel; Nigrovic, Peter A

    2016-05-01

    The small size of many pediatric rheumatology programs translates into limited mentoring options for early career physicians. To address this problem, the American College of Rheumatology (ACR) and the Childhood Arthritis and Rheumatology Research Alliance (CARRA) developed a subspecialty-wide interinstitutional mentoring program, the ACR/CARRA Mentoring Interest Group (AMIGO). We sought to assess the impact of this program on mentoring within pediatric rheumatology. In a longitudinal 3-year study, participant ratings from the AMIGO pilot program were compared with those after the program was opened to general enrollment. Access to mentoring as a function of career stage was assessed by surveys of the US and Canadian pediatric rheumatologists in 2011 and 2014, before and after implementation of AMIGO. Participants in the pilot phase (19 dyads) and the general implementation phase (112 dyads) reported comparable success in establishing mentor contact, suitability of mentor-mentee pairing, and benefit with respect to career development, scholarship, and work-life balance. Community surveys showed that AMIGO participation as mentee was high among fellows (86%) and modest among junior faculty (31%). Implementation correlated with significant gains in breadth of mentorship and in overall satisfaction with mentoring for fellows but not junior faculty. AMIGO is a career mentoring program that serves most fellows and many junior faculty in pediatric rheumatology across the US and Canada. Program evaluation data confirm that a subspecialty-wide interinstitutional mentoring program is feasible and can translate into concrete improvement in mentoring, measurable at the level of the whole professional community. © 2016, American College of Rheumatology.

  8. [Hospital financing in 2016. Relevant changes for rheumatology].

    Science.gov (United States)

    Fiori, W; Bunzemeier, H; Lakomek, H-J; Buscham, K; Lehmann, H; Fuchs, A-K; Bessler, F; Roeder, N

    2016-03-01

    Hospital financing 2016 will be influenced by the prospects of the approaching considerable changes. It is assumed that the following years will lead to a considerable reallocation of financial resources between hospitals. While not directly targeted by new regulations, reallocations always also affect specialties like rheumatology. Compared to the alterations in the legislative framework the financial effects of the yearly adaptation of the German diagnosis-related groups system are subordinate. Only by comprehensive consideration of current and expected changes a forward-looking and sustainable strategy can be developed. The following article presents the relevant changes and discusses the consequences for hospitals specialized in rheumatology.

  9. International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials

    DEFF Research Database (Denmark)

    Orbai, Ana-Maria; de Wit, Maarten; Mease, Philip

    2017-01-01

    OBJECTIVE: To identify a core set of domains (outcomes) to be measured in psoriatic arthritis (PsA) clinical trials that represent both patients' and physicians' priorities. METHODS: We conducted (1) a systematic literature review (SLR) of domains assessed in PsA; (2) international focus groups t...

  10. The law of international criminal procedure and domestic war crimes trials

    NARCIS (Netherlands)

    Sluiter, G.

    2006-01-01

    This article deals with the question of possible effect of the law of international criminal procedure for domestic war crimes trials. With the increasing number of national prosecutions for war crimes this question will gain in relevance. The article starts with an exploration of the origin and

  11. GATEWAY Demonstrations: Philadelphia International Airport Apron Lighting: LED System Performance in a Trial Installation

    Energy Technology Data Exchange (ETDEWEB)

    Davis, Robert G. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Wilkerson, Andrea M. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2015-10-30

    This report documents a trial installation of LED apron lighting that replaced the existing high-pressure sodium luminaires at Philadelphia International Airport. Such high-mast applications remain challenging for LED technology, and the lessons learned from this project may help facility managers and LED product manufacturers better meet those challenges.

  12. Effects of Assertiveness Training and Expressive Writing on Acculturative Stress in International Students: A Randomized Trial

    Science.gov (United States)

    Tavakoli, Shedeh; Lumley, Mark A.; Hijazi, Alaa M.; Slavin-Spenny, Olga M.; Parris, George P.

    2009-01-01

    International university students often experience acculturative stress, and culturally appropriate techniques to manage stress are needed. This randomized trial tested the effects of group assertiveness training, private expressive writing, their combination, and a wait-list control on the acculturative stress, affect, and health of 118…

  13. The pre-trial procedures and principles of the International Criminal ...

    African Journals Online (AJOL)

    The pre-trial procedures and principles of the International Criminal Court. ... the accused persons were done ex-post facto and devoid of any country's law. ... Against this background, this paper attempts to put the ambiguities aside and ...

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

    NARCIS (Netherlands)

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

    2017-01-01

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

  15. Methodological aspects of clinical trials in tinnitus: A proposal for an international standard

    Science.gov (United States)

    Landgrebe, Michael; Azevedo, Andréia; Baguley, David; Bauer, Carol; Cacace, Anthony; Coelho, Claudia; Dornhoffer, John; Figueiredo, Ricardo; Flor, Herta; Hajak, Goeran; van de Heyning, Paul; Hiller, Wolfgang; Khedr, Eman; Kleinjung, Tobias; Koller, Michael; Lainez, Jose Miguel; Londero, Alain; Martin, William H.; Mennemeier, Mark; Piccirillo, Jay; De Ridder, Dirk; Rupprecht, Rainer; Searchfield, Grant; Vanneste, Sven; Zeman, Florian; Langguth, Berthold

    2013-01-01

    Chronic tinnitus is a common condition with a high burden of disease. While many different treatments are used in clinical practice, the evidence for the efficacy of these treatments is low and the variance of treatment response between individuals is high. This is most likely due to the great heterogeneity of tinnitus with respect to clinical features as well as underlying pathophysiological mechanisms. There is a clear need to find effective treatment options in tinnitus, however, clinical trials differ substantially with respect to methodological quality and design. Consequently, the conclusions that can be derived from these studies are limited and jeopardize comparison between studies. Here, we discuss our view of the most important aspects of trial design in clinical studies in tinnitus and make suggestions for an international methodological standard in tinnitus trials. We hope that the proposed methodological standard will stimulate scientific discussion and will help to improve the quality of trials in tinnitus. PMID:22789414

  16. Barriers and Facilitators of Mentoring for Trainees and Early Career Investigators in Rheumatology Research: Current State, Identification of Needs, and Road Map to an Inter-Institutional Adult Rheumatology Mentoring Program.

    Science.gov (United States)

    Ogdie, Alexis; Sparks, Jeffrey A; Angeles-Han, Sheila T; Bush, Kathleen; Castelino, Flavia V; Golding, Amit; Jiang, Yihui; Kahlenberg, J Michelle; Kim, Alfred H J; Lee, Yvonne C; Machireddy, Kirthi; Ombrello, Michael J; Shah, Ami A; Wallace, Zachary S; Nigrovic, Peter A; Makris, Una E

    2018-03-01

    To determine perceived barriers and facilitators to effective mentoring for early career rheumatology investigators and to develop a framework for an inter-institutional mentoring program. Focus groups or interviews with rheumatology fellows, junior faculty, and mentors were conducted, audiorecorded, and transcribed. Content analysis was performed using NVivo software. Themes were grouped into categories (e.g., mentor-mentee relationship, barriers, and facilitators of a productive relationship). Rheumatology fellows and early career investigators were also surveyed nationwide to identify specific needs to be addressed through an inter-institutional mentoring program. Twenty-five individuals participated in focus groups or interviews. Attributes of the ideal mentee-mentor relationship included communication, accessibility, regular meetings, shared interests, aligned goals, and mutual respect. The mentee should be proactive, efficient, engaged, committed, focused, accountable, and respectful of the mentor's time. The mentor should support/promote the mentee, shape the mentee's goals and career plan, address day-to-day questions, provide critical feedback, be available, and have team leadership skills. Barriers included difficulty with career path navigation, gaining independence, internal competition, authorship, time demands, funding, and work-life balance. Facilitators of a successful relationship included having a diverse network of mentors filling different roles, mentor-mentee relationship management, and confidence. Among 187 survey respondents, the primary uses of an inter-institutional mentoring program were career development planning and oversight, goal-setting, and networking. In this mixed-methods study, tangible factors for optimizing the mentor-mentee relationship were identified and will inform the development of an adult rheumatology inter-institutional mentoring program. © 2017, American College of Rheumatology.

  17. Toward the Development of a Core Set of Outcome Domains to Assess Shared Decision-making Interventions in Rheumatology

    DEFF Research Database (Denmark)

    Toupin-April, Karine; Barton, Jennifer; Fraenkel, Liana

    2017-01-01

    OBJECTIVE: The aim of this Outcome Measures in Rheumatology (OMERACT) Working Group was to determine the core set of outcome domains and subdomains for measuring the effectiveness of shared decision-making (SDM) interventions in rheumatology clinical trials. METHODS: Following the OMERACT Filter 2.......0, and based on a previous literature review of SDM outcome domains and a nominal group process at OMERACT 2014, (1) an online Delphi survey was conducted to gather feedback on the draft core set and refine its domains and subdomains, and (2) a workshop was held at the OMERACT 2016 meeting to gain consensus...... ranged from 83% to 100% of respondents). At OMERACT 2016, only 8% of the 96 attendees were patients/caregivers. Despite initial votes of support in breakout groups, there was insufficient comfort about the conceptualization of these 7 domains and 17 subdomains for these to be endorsed at OMERACT 2016...

  18. The effects of a randomised multi-centre trial and international accreditation on availability and quality of clinical guidelines

    DEFF Research Database (Denmark)

    Juul, Anne Benedicte; Gluud, Christian; Wetterslev, Jørn

    2005-01-01

    To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation.......To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation....

  19. Pediatric rheumatology: An under-recognized subspecialty in India

    Directory of Open Access Journals (Sweden)

    Akhila Kavirayani

    2017-01-01

    Full Text Available Pediatrics in India at the levels of both undergraduate and postgraduate training is often viewed upon as an acute disease specialty with little emphasis on chronic medical musculoskeletal diseases. Pediatric rheumatology is an under-recognized subspecialty of pediatrics which deals specifically with childhood arthritis, noninflammatory joint pains, connective tissue diseases, autoimmune diseases, vasculitis, and other rare inflammatory disorders. This article aims to give a bird's eye view of the repertoire of commonly encountered problems seen by a pediatric rheumatologist, via a classical case vignette for each topic followed by discussion. There is also mention of some rare diseases managed within pediatric rheumatology to give a flavor of the spectrum of diseases encountered. This is to raise awareness of the importance of pediatric rheumatology as a subspecialty within India and to prompt readers to seek specialist advice when encountering challenging cases. Pediatric rheumatologists network and work collaboratively with many other specialties such as ophthalmology, dermatology, neurology, orthopedics, nephrology, infectious diseases, immunology, and gastroenterology for combined care of diverse conditions. There is an unmet need in India to develop a training program for pediatric rheumatology so that shared care pathways with sensitized pediatricians and other specialists can be developed nationwide, to serve these children better to achieve optimal outcomes.

  20. Rheumatology training experience across Europe: analysis of core competences

    NARCIS (Netherlands)

    Sivera, Francisca; Ramiro, Sofia; Cikes, Nada; Cutolo, Maurizio; Dougados, Maxime; Gossec, Laure; Kvien, Tore K.; Lundberg, Ingrid E.; Mandl, Peter; Moorthy, Arumugam; Panchal, Sonia; Da Silva, José A. P.; Bijlsma, Johannes W.; Ҫollaku, Ledio; Aroyan, Armine; Radner, Helga; Tushina, Anastasyia; de Langhe, Ellen; Sokolovic, Sekib; Shumnalieva, Russka; Baresic, Marko; Senolt, Ladislav; Holland-Fischer, Mette; Kull, Mart; Puolitaival, Antti; Gobejishvili, Nino; Hueber, Axel; Fanouriakis, Antonis; MacMullan, Paul; Rimar, Doron; Bugatti, Serena; Zepa, Julija; Menassa, Jeanine; Karpec, Diana; Misevska-Percinkova, Snezana; Cassar, Karen; Deseatnicova, Elena; Tas, SanderW; Lie, Elisabeth; Sznajd, Jan; Berghea, Florian; Povzun, Anton; Jeremic, Ivica; Mlynarikova, Vanda; Frank-Bertoncelj, Mojca; Chatzidionysiou, Katerina; Dumusc, Alexandre; Hatemi, Gulen; Ozdemirel, Erhan; Biliavska, Iuliia

    2016-01-01

    Background: The aim of this project was to analyze and compare the educational experience in rheumatology specialty training programs across European countries, with a focus on self-reported ability. Method: An electronic survey was designed to assess the training experience in terms of

  1. Educational needs of health professionals working in rheumatology in Europe.

    Science.gov (United States)

    Vliet Vlieland, Theodora P M; van den Ende, Cornelia H M; Alliot-Launois, Francoise; Beauvais, Catherine; Gobbo, Milena; Iagnocco, Annamaria; Lundberg, Ingrid E; Munuera-Martínez, Pedro V; Opava, Christina H; Prior, Yeliz; Redmond, Anthony; Smucrova, Hana; Wiek, Dieter

    2016-01-01

    To explore the availability of postgraduate education for health professionals (HPs) working in rheumatology in Europe, and their perceived educational needs and barriers for participation in current educational offerings. Structured interviews were conducted with national representatives of rheumatology HPs' organisations and an online survey among individual HPs was disseminated through existing European League Against Rheumatism (EULAR) networks (10 languages including English). These comprised questions on: availability of postgraduate education, familiarity with EULAR and its educational offerings, unmet needs regarding the contents and mode of delivery and potential barriers to participate in education (0-10 scales). According to 17 national representatives, postgraduate rheumatology education was most common for nurses, physical and occupational therapists. There were 1041 individuals responding to the survey, of whom 48% completed all questions. More than half (56%) were familiar with EULAR as an organisation, whereas rheumatology education for HPs in most countries. There are opportunities to raise awareness regarding EULAR educational offerings and to develop courses provided in HPs' own country, tailored to national needs and barriers and taking language barriers into consideration.

  2. Correlative Studies in Clinical Trials: A Position Statement From the International Thyroid Oncology Group.

    Science.gov (United States)

    Bible, Keith C; Cote, Gilbert J; Demeure, Michael J; Elisei, Rossella; Jhiang, Sissy; Ringel, Matthew D

    2015-12-01

    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.

  3. Will the judgment in the Hague trial constitute a precedent in international law

    Directory of Open Access Journals (Sweden)

    Bojanić Petar

    2006-01-01

    Full Text Available On the great crime (mala in se; scelus infandum and sovereignty In this text we are attempting to think the International Criminal Tribunal for the former Yugoslavia together, and always with its necessary connection to the International Court of Justice and International Criminal Court. By paraphrasing the title of another work, the long forgotten Hans Kelsen text from 1947 (today usually used by detractors of the Tribunal "Will the Judgment in the Nuremberg Trial constitute a Precedent in International Law?", I wish to distinguish between the two Tribunals (as well as The Treaty of Versaille,and in so doing treat international law as legislative history or judicial precedents (and their recognition.

  4. APS ACTION--AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking.

    Science.gov (United States)

    Erkan, D; Lockshin, M D

    2012-06-01

    AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking (APS ACTION) is the first-ever international research network that has been created specifically to design and conduct well-designed, large-scale, multi-center clinical trials in persistently antiphospholipid antibody (aPL)-positive patients. The founding principle of the APS ACTION is that it is an internationally collaborative effort, open to qualified investigators across the globe who are committed to furthering our understanding of APS and its management. Due to the hard work and collaborative spirit of APS ACTION members, in early 2012, APS ACTION launched two important collaborative international projects: 1) a randomized controlled trial of hydroxychloroquine in the primary thrombosis prevention of persistently aPL-positive but thrombosis-free patients without other systemic autoimmune diseases; and 2) a web-based registry of aPL-positive patients with or without systemic autoimmune diseases, which will also include annual blood collection for aPL-testing and future basic science studies. In the end, we hope to find better treatments for antiphospholipid syndrome, which is a leading cause of thrombosis, pregnancy morbidity and other life-altering consequences, and to heighten awareness about this life-threatening, autoimmune condition.

  5. Reporting and evaluation of HIV-related clinical endpoints in two multicenter international clinical trials

    DEFF Research Database (Denmark)

    Lifson, A; Rhame, F; Bellosa, W

    2006-01-01

    adjudication between reviewers before diagnostic certainty was assigned. CONCLUSION: Important requirements for HIV trials using clinical endpoints include objective definitions of "confirmed" and "probable," a formal reporting process with adequate information and supporting source documentation, evaluation......PURPOSE: The processes for reporting and review of progression of HIV disease clinical endpoints are described for two large phase III international clinical trials. METHOD: SILCAAT and ESPRIT are multicenter randomized HIV trials evaluating the impact of interleukin-2 on disease progression...... and death in HIV-infected patients receiving antiretroviral therapy. We report definitions used for HIV progression of disease endpoints, procedures for site reporting of such events, processes for independent review of reported events by an Endpoint Review Committee (ERC), and the procedure...

  6. Rates and determinants of informed consent: a case study of an international thromboprophylaxis trial.

    Science.gov (United States)

    Smith, Orla M; McDonald, Ellen; Zytaruk, Nicole; Foster, Denise; Matte, Andrea; Clarke, France; Meade, Laurie; O'Callaghan, Nicole; Vallance, Shirley; Galt, Pauline; Rajbhandari, Dorrilyn; Rocha, Marcelo; Mehta, Sangeeta; Ferguson, Niall D; Hall, Richard; Fowler, Robert; Burns, Karen; Qushmaq, Ismael; Ostermann, Marlies; Heels-Ansdell, Diane; Cook, Deborah

    2013-02-01

    Successful completion of randomized trials depends upon efficiently and ethically screening patients and obtaining informed consent. Awareness of modifiable barriers to obtaining consent may inform ongoing and future trials. The objective of this study is to describe and examine determinants of consent rates in an international heparin thromboprophylaxis trial (Prophylaxis for ThromboEmbolism in Critical Care Trial, clinicaltrials.gov NCT00182143). Throughout the 4-year trial, research personnel approached eligible critically ill patients or their substitute decision makers for informed consent. Whether consent was obtained or declined was documented daily. The trial was conducted in 67 centers in 6 countries. A total of 3764 patients were randomized. The overall consent rate was 82.2% (range, 50%-100%) across participating centers. Consent was obtained from substitute decision makers and patients in 90.1% and 9.9% of cases, respectively. Five factors were independently associated with consent rates. Research coordinators with more experience achieved higher consent rates (odds ratio [OR], 3.43; 95% confidence interval, 2.42-4.86; P 10 years of experience). Consent rates were higher in smaller intensive care units with less than 15 beds compared with intensive care units with 15 to 20 beds, 21 to 25 beds, and greater than 25 beds (all ORs, <0.5; P < .001) and were higher in centers with more than 1 full-time research staff (OR, 1.95; 95% confidence interval, 1.28-2.99; P < .001). Consent rates were lower in centers affiliated with the Canadian Critical Care Trials Group or the Australian and New Zealand Intensive Care Society Clinical Trials Group compared with other centers (OR, 0.57; 95% confidence interval, 0.42-0.77; P < .001). Finally, consent rates were highest during the pilot trial, lowest during the initiation of the full trial, and increased over years of recruitment (P < .001). Characteristics of study centers, research infrastructure, and experience

  7. Update of the International Consensus on Palliative Radiotherapy Endpoints for Future Clinical Trials in Bone Metastases

    Energy Technology Data Exchange (ETDEWEB)

    Chow, Edward, E-mail: Edward.Chow@sunnybrook.ca [Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON (Canada); Hoskin, Peter [Mount Vernon Centre for Cancer Treatment, Mount Vernon Hospital, Northwood, Middlesex (United Kingdom); Mitera, Gunita; Zeng Liang [Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON (Canada); Lutz, Stephen [Department of Radiation Oncology, Blanchard Valley Regional Cancer Center, Findlay, OH (United States); Roos, Daniel [Department of Radiation Oncology, Royal Adelaide Hospital, Adelaide, South Australia (Australia); Hahn, Carol [Department of Radiation Oncology, Duke University Medical Center, Durham, NC (United States); Linden, Yvette van der [Radiotherapeutic Institute Friesland, Leeuwarden (Netherlands); Hartsell, William [Department of Radiation Oncology, Advocate Good Samaritan Cancer Center, Downers Grove, IL (United States); Kumar, Eshwar [Department of Oncology, Atlantic Health Sciences Cancer Centre, Saint John Regional Hospital, Saint John, NB (Canada)

    2012-04-01

    Purpose: To update the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases by surveying international experts regarding previous uncertainties within the 2002 consensus, changes that may be necessary based on practice pattern changes and research findings since that time. Methods and Materials: A two-phase survey was used to determine revisions and new additions to the 2002 consensus. A total of 49 experts from the American Society for Radiation Oncology, the European Society for Therapeutic Radiology and Oncology, the Faculty of Radiation Oncology of the Royal Australian and New Zealand College of Radiologists, and the Canadian Association of Radiation Oncology who are directly involved in the care of patients with bone metastases participated in this survey. Results: Consensus was established in areas involving response definitions, eligibility criteria for future trials, reirradiation, changes in systemic therapy, radiation techniques, parameters at follow-up, and timing of assessments. Conclusion: An outline for trials in bone metastases was updated based on survey and consensus. Investigators leading trials in bone metastases are encouraged to adopt the revised guideline to promote consistent reporting. Areas for future research were identified. It is intended for the consensus to be re-examined in the future on a regular basis.

  8. Update of the International Consensus on Palliative Radiotherapy Endpoints for Future Clinical Trials in Bone Metastases

    International Nuclear Information System (INIS)

    Chow, Edward; Hoskin, Peter; Mitera, Gunita; Zeng Liang; Lutz, Stephen; Roos, Daniel; Hahn, Carol; Linden, Yvette van der; Hartsell, William; Kumar, Eshwar

    2012-01-01

    Purpose: To update the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases by surveying international experts regarding previous uncertainties within the 2002 consensus, changes that may be necessary based on practice pattern changes and research findings since that time. Methods and Materials: A two-phase survey was used to determine revisions and new additions to the 2002 consensus. A total of 49 experts from the American Society for Radiation Oncology, the European Society for Therapeutic Radiology and Oncology, the Faculty of Radiation Oncology of the Royal Australian and New Zealand College of Radiologists, and the Canadian Association of Radiation Oncology who are directly involved in the care of patients with bone metastases participated in this survey. Results: Consensus was established in areas involving response definitions, eligibility criteria for future trials, reirradiation, changes in systemic therapy, radiation techniques, parameters at follow-up, and timing of assessments. Conclusion: An outline for trials in bone metastases was updated based on survey and consensus. Investigators leading trials in bone metastases are encouraged to adopt the revised guideline to promote consistent reporting. Areas for future research were identified. It is intended for the consensus to be re-examined in the future on a regular basis.

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

    OpenAIRE

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

    2017-01-01

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

  10. How to prescribe physical exercise in rheumatology

    Directory of Open Access Journals (Sweden)

    S. Maddali Bongi

    2011-06-01

    Full Text Available Physical exercise, aiming to improve range of movement, muscle strength and physical well being, lately substituted the immobilization previously prescribed in rheumatic diseases. International guidelines, recommendations of Scientific Societies, and structured reviews regard physical exercise as of pivotal importance in treating rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, fibromyalgia syndrome, osteoporosis, and to be considered in connective tissue diseases. Therapeutic exercise should: aim to improve firstly local symptoms and then general health; respect the pain threshold; be a part of a treatment including pharmacological therapies and other rehabilitation techniques, be administered by skilled physiotherapist under the guide of a rheumatologist, be different according to different diseases, disease phases and patient expectations.

  11. Autoimmune thyroiditis in antinuclear antibody positive children without rheumatologic disease

    Directory of Open Access Journals (Sweden)

    Arkachaisri Thaschawee

    2010-05-01

    Full Text Available Abstract Background Children are commonly referred to a pediatric rheumatology center for the laboratory finding of an Anti-nuclear antibody (ANA of undetermined significance. Previous studies regarding adult rheumatology patients have supported an association between ANA and anti-thyroid antibodies, with the prevalence of thyroid antibodies being significantly higher in patients referred to a rheumatology center for an ANA without evidence of connective tissue disease compared to the general population. The purpose of the present study was to determine the frequency of thyroid antibodies in children referred to a pediatric rheumatology center for a positive ANA without evidence of a connective tissue disease. Methods A retrospective chart review was performed on children who were referred to our pediatric rheumatology center between August 2003 and March 2007 for positive ANA with concurrent thyroid antibody and thyroid function tests performed who did not fulfill criteria for a specific connective tissue disease. Laboratory and clinical features were recorded and analyzed. Mean and standard deviation were used to describe continuous data. Chi-square or Fisher's exact tests were used to compare proportions between variables. Results One-hundred and four ANA-positive patients with concurrent thyroid studies were evaluated (88% female, 93% Caucasian, mean age 11.9 ± 4.0 years. Half of patients had an ANA titer ≥ 1:320. The ANA pattern was speckled in 60% of the patients. Thyroid antibodies were detected in 30% of the patients. Anti-Thyroglobulin (ATG was detected in 29% and Anti-thyroid peroxidase (ATPO in 21% of the patients; of these children, 14% had hypothyroidism. ANA pattern and titer were not associated with anti-thyroid antibody positivity. Conclusion Thyroid antibodies associated with chronic lymphocytic thyroiditis, ATG and ATPO, were detected significantly higher in ANA-positive children without a rheumatologic condition (30% as

  12. Secukinumab for rheumatology: development and its potential place in therapy

    Directory of Open Access Journals (Sweden)

    Koenders MI

    2016-06-01

    Full Text Available Marije I Koenders, Wim B van den Berg Experimental Rheumatology, Radboud University Medical Center, Nijmegen, the Netherlands Abstract: Rheumatic disease is not a single disorder, but a group of more than 100 diseases that affect joints, connective tissues, and/or internal organs. Although rheumatic diseases like rheumatoid arthritis (RA, psoriatic arthritis, and ankylosing spondylitis (AS differ in their pathogenesis and clinical presentation, the treatment of these inflammatory disorders overlaps. Non-steroid anti-inflammatory drugs are used to reduce pain and inflammation. Additional disease-modifying anti-rheumatic drugs are prescribed to slowdown disease progression, and is in RA more frequently and effectively applied than in AS. Biologicals are a relatively new class of treatments that specifically target cytokines or cells of the immune system, like tumor necrosis factor alpha inhibitors or B-cell blockers. A new kid on the block is the interleukin-17 (IL-17 inhibitor secukinumab, which has been recently approved by the US Food and Drug Administration for moderate-to-severe plaque psoriasis, psoriatic arthritis, and AS. IL-17 is a proinflammatory cytokine that has an important role in host defense, but its proinflammatory and destructive effects have also been linked to pathogenic processes in autoimmune diseases like RA and psoriasis. Animal models have greatly contributed to further insights in the potential of IL-17 blockade in autoimmune and autoinflammatory diseases, and have resulted in the development of various potential drugs targeting the IL-17 pathway. Secukinumab (AIN457 is a fully human monoclonal antibody that selectively binds to IL-17A and recently entered the market under the brand name Cosentyx®. By binding to IL-17A, secukinumab prevents it from binding to its receptor and inhibits its ability to trigger inflammatory responses that play a role in the development of various autoimmune diseases. With secukinumab being

  13. Aceclofenac in rheumatology: The golden mean

    Directory of Open Access Journals (Sweden)

    Andrei Evgenyevich Karateev

    2013-01-01

    Full Text Available Effective pain relief is an essential component of combination therapy for rheumatic diseases (RD. Amongst analgesics, there are nonsteroidal anti-inflammatory drugs (NSAIDs that hold a central position. Nineteen different representatives of this group are currently used in Russia, which allows the most appropriate medication to be chosen for each clinical situation and a specific patient. The primary difference between NSAIDs is their safety. There are two polar groups of NSAIDs: 1 nonselective COX-2 inhibitors (nNSAIDS that rather frequently cause complications in the gastrointestinal tract (GIT, but are safer for the cardiovascular system; and 2 highly selective COX-2 inhibitors (coxibs that are, on the contrary, characterized by a lower risk for GIT disease, but a higher risk for cardiovascular events. Aceclofenac, a drug that has moderate COX-2 selectivity, holds a good position between nNSAIDs and coxibs, which makes its use advisable for most patients with RD. Clinical trials and epidemiological studies show that both the GIT and cardiovascular system well tolerate the drug. This review gives the basic data pertaining to the evaluation of the safety of aceclofenac, including the results of the last (2012 meta-analysis of population-based studies of the risk of GIT bleeding due to the use of various NSAIDs and those of the AEROPLAN Russian study (of aceclofenac versus nimesulide.

  14. Randomized controlled trial of internal and external targeted temperature management methods in post- cardiac arrest patients.

    Science.gov (United States)

    Look, Xinqi; Li, Huihua; Ng, Mingwei; Lim, Eric Tien Siang; Pothiawala, Sohil; Tan, Kenneth Boon Kiat; Sewa, Duu Wen; Shahidah, Nur; Pek, Pin Pin; Ong, Marcus Eng Hock

    2018-01-01

    Targeted temperature management post-cardiac arrest is currently implemented using various methods, broadly categorized as internal and external. This study aimed to evaluate survival-to-hospital discharge and neurological outcomes (Glasgow-Pittsburgh Score) of post-cardiac arrest patients undergoing internal cooling verses external cooling. A randomized controlled trial of post-resuscitation cardiac arrest patients was conducted from October 2008-September 2014. Patients were randomized to either internal or external cooling methods. Historical controls were selected matched by age and gender. Analysis using SPSS version 21.0 presented descriptive statistics and frequencies while univariate logistic regression was done using R 3.1.3. 23 patients were randomized to internal cooling and 22 patients to external cooling and 42 matched controls were selected. No significant difference was seen between internal and external cooling in terms of survival, neurological outcomes and complications. However in the internal cooling arm, there was lower risk of developing overcooling (p=0.01) and rebound hyperthermia (p=0.02). Compared to normothermia, internal cooling had higher survival (OR=3.36, 95% CI=(1.130, 10.412), and lower risk of developing cardiac arrhythmias (OR=0.18, 95% CI=(0.04, 0.63)). Subgroup analysis showed those with cardiac cause of arrest (OR=4.29, 95% CI=(1.26, 15.80)) and sustained ROSC (OR=5.50, 95% CI=(1.64, 20.39)) had better survival with internal cooling compared to normothermia. Cooling curves showed tighter temperature control for internal compared to external cooling. Internal cooling showed tighter temperature control compared to external cooling. Internal cooling can potentially provide better survival-to-hospital discharge outcomes and reduce cardiac arrhythmia complications in carefully selected patients as compared to normothermia. Copyright © 2017. Published by Elsevier Inc.

  15. The Women's international study of long-duration oestrogen after menopause (WISDOM: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Meade Tom W

    2007-02-01

    The trial was prematurely closed during recruitment following publication of early results from the Women's Health Initiative. At the time of closure, 56583 had been screened, 8980 entered run-in, and 5694 (26% of target of 22,300 randomised. Those women randomised had received a mean of one year of therapy, mean age was 62.8 years and total follow-up time was 6491 person years. Discussion The WISDOM experience leads to some simple messages. The larger a trial is the more simple it needs to be to ensure cost effective and timely delivery. When a trial is very costly and beyond the resources of one country, funders and investigators should make every effort to develop international collaboration with joint funding.

  16. Capillaroscopy – a role in modern rheumatology

    Directory of Open Access Journals (Sweden)

    Marek M. Chojnowski

    2016-06-01

    Full Text Available Capillaroscopy is a non-invasive, easy and safe diagnostic technique designed to evaluate small vessels of the microcirculation in the nailfold. It can reveal both the general architecture of capillary rows and fine details of particular vessels. The most important indications for performing capillaroscopy include differential diagnosis of primary and secondary Raynaud’s phenomenon, as well as assessment of scleroderma spectrum disorders. In systemic sclerosis capillary abnormalities appear and evolve in a clearly defined sequence called the scleroderma pattern, which correlates with internal organ involvement. Capillaroscopy is also listed as a systemic sclerosis classification criterion recognized by the European League Against Rheumatism (EULAR. With digitized equipment, capillaroscopy allows for precise qualitative and quantitative evaluation of the microcirculation and is a valuable tool in the rheumatologists’ daily practice.

  17. Capillaroscopy - a role in modern rheumatology.

    Science.gov (United States)

    Chojnowski, Marek M; Felis-Giemza, Anna; Olesińska, Marzena

    2016-01-01

    Capillaroscopy is a non-invasive, easy and safe diagnostic technique designed to evaluate small vessels of the microcirculation in the nailfold. It can reveal both the general architecture of capillary rows and fine details of particular vessels. The most important indications for performing capillaroscopy include differential diagnosis of primary and secondary Raynaud's phenomenon, as well as assessment of scleroderma spectrum disorders. In systemic sclerosis capillary abnormalities appear and evolve in a clearly defined sequence called the scleroderma pattern, which correlates with internal organ involvement. Capillaroscopy is also listed as a systemic sclerosis classification criterion recognized by the European League Against Rheumatism (EULAR). With digitized equipment, capillaroscopy allows for precise qualitative and quantitative evaluation of the microcirculation and is a valuable tool in the rheumatologists' daily practice.

  18. Long-term, interventional, open-label extension study evaluating the safety of tocilizumab treatment in patients with polyarticular-course juvenile idiopathic arthritis from Poland and Russia who completed the global, international CHERISH trial.

    Science.gov (United States)

    Opoka-Winiarska, Violetta; Żuber, Zbigniew; Alexeeva, Ekaterina; Chasnyk, Vyacheslav; Nikishina, Irina; Dębowska, Grażyna; Smolewska, Elżbieta

    2018-04-13

    Efficacy and safety of tocilizumab (TCZ), an interleukin-6 receptor inhibitor, were demonstrated in juvenile idiopathic arthritis (JIA) with polyarticular course (pJIA) in the CHERISH trial. This observational, III phase study evaluated long-term treatment of TCZ in pJIA patients was conducted by members of the Pediatric Rheumatology International Trials Organization (PRINTO) from Poland and Russia. Forty-one patients, who had completed the CHERISH core study (104 weeks), were extensionally treated with TCZ (8 mg/kg, intravenous infusion every 4 weeks). Total treatment time was from 131 to 193 weeks. The long-term safety (the primary endpoint) and efficacy were evaluated. All patients achieved ACR70 response in the core study and continued to achieve at least ACR50 response up to week 24 of this study. The safety population comprised 46.41 patient-years (PY). Rates per 100 PY of adverse (AEs) and serious events (SAEs) were 181.0 and 6.46, respectively. Pharyngitis and respiratory tract infections were the most common AEs. Except one AE (severe neutropenia), all others were classified as mild (24.4%) or moderate (29.3%). The incidence of SAEs was low (7.3%). No new safety findings were observed. The safety profile of over 2.5-year treatment with TCZ is consistent with the pre-marketing CHERISH clinical trial. Presented data and continued efficacy response support the use of TCZ in pJIA. EUDRACT No: 2011-001607-12. https://clinicaltrials.gov/ct2/show/study/NCT01575769?term=ML27783.

  19. Methodological issues for designing and conducting a multicenter, international clinical trial in Acute Stroke: Experience from ARTSS-2 trial.

    Science.gov (United States)

    Rahbar, Mohammad H; Dickerson, Aisha S; Cai, Chunyan; Pedroza, Claudia; Hessabi, Manouchehr; Shen, Loren; Pandurengan, Renganayaki; Jacobs, Amber Nicole M; Indupuru, Hari; Sline, Melvin R; Delgado, Rigoberto I; Macdonald, Claire; Ford, Gary A; Grotta, James C; Barreto, Andrew D

    2015-09-01

    We describe innovations in the study design and the efficient data coordination of a randomized multicenter trial of Argatroban in Combination with Recombinant Tissue Plasminogen Activator for Acute Stroke (ARTSS-2). ARTSS-2 is a 3-arm, multisite/multiregional randomized controlled trials (RCTs) of two doses of Argatroban injection (low, high) in combination with recombinant tissue plasminogen activator (rt-PA) in acute ischemic stroke patients and rt-PA alone. We developed a covariate adaptive randomization program that balanced the study arms with respect to study site as well as hemorrhage after thrombolysis (HAT) score and presence of distal internal carotid artery occlusion (DICAO). We used simulation studies to validate performance of the randomization program before making any adaptations during the trial. For the first 90 patients enrolled in ARTSS-2, we evaluated performance of our randomization program using chi-square tests of homogeneity or extended Fisher's exact test. We also designed a four-step partly Bayesian safety stopping rule for low and high dose Argatroban arms. Homogeneity of the study arms was confirmed with respect to distribution of study site (UK sites vs. US sites, P=0.98), HAT score (0-2 vs. 3-5, P=1.0), and DICAO (N/A vs. No vs. Yes, P=0.97). Our stopping thresholds for safety of low and high dose Argatroban were not crossed. Despite challenges, data quality was assured. We recommend adaptive designs for randomization and Bayesian safety stopping rules for multisite Phase I/II RCTs for maintaining additional flexibility. Efficient data coordination could lead to improved data quality. Copyright © 2015. Published by Elsevier Inc.

  20. A brief history of ultrasound in rheumatology: where we were.

    Science.gov (United States)

    Grassi, Walter; Filippucci, Emilio

    2014-01-01

    Ultrasonography in the '70s was a well-known and widely used method within several medical specialties but not in rheumatology. Initial development of the field was led by radiologists who mainly investigated the potential of ultrasound in the assessment of large joints. In the late '80s, the first studies supporting the role of ultrasound in the detection of soft tissue changes and bone erosions in the hands of patients with rheumatoid arthritis were published. In the '90s, the dramatic improvement of spatial resolution due to the new generation high frequency probes opened up new avenues for the exploration of otherwise undetectable anatomical details. Ultrasound research during this period was enhanced by the growing use of colour Doppler and power Doppler and by the first prototypes of three dimensional ultrasound. Over the last 10 years, the buzz words in ultrasound research in rheumatology have been standardisation, early diagnosis and therapy monitoring.

  1. [G-DRG system 2009: relevant changes for rheumatology].

    Science.gov (United States)

    Fiori, W; Liedtke-Dyong, A; Lakomek, H-J; Buscham, K; Lehmann, H; Liman, W; Fuchs, A-K; Bessler, F; Roeder, N

    2009-08-01

    The following article presents the main general and specific changes in the G-DRG (German diagnosis-related groups) system in terms of the classification systems for diagnoses and procedures as well as the billing process for 2009. Of fundamental relevance is the national weighting of the G-DRG I97Z (complex rheumatologic treatment), which up to now had to be negotiated individually by each hospital. Emphasis is also put on case auditing by the health insurers. Being primarily a tool for redistribution of resources, every hospital has to analyze the economic effects of the 2009 G-DRG system by applying the G-DRG transition grouper to its own cases. Depending on their clinical focus rheumatological departments may experience positive or negative consequences from the development. The strain imposed on hospitals by inadequate refunding of rising costs has to be assessed separately from the effects of redistribution by the G-DRG system.

  2. [The G-DRG system 2008. Relevant changes for rheumatology].

    Science.gov (United States)

    Fiori, W; Lakomek, H-J; Buscham, K; Lehmann, H; Liman, W; Fuchs, A-K; Hülsemann, J L; Roeder, N

    2008-05-01

    The G-DRG system 2008 once again brings many changes to rheumatological departments in Germany. The following article presents the main general and specific changes in the G-DRG system, as well as in the classification systems for diagnoses and procedures and in invoicing for 2008. Since the G-DRG system is only a tool for the redistribution of resources, every hospital needs to analyze the economic effects of the system by applying the G-DRG transition grouper to its own cases. Depending on their clinical focus, rheumatological departments may experience positive or negative effects from the system's application. The strain placed on hospitals by the inadequate funding of increased costs needs to be assessed separately from the effects of redistribution by the G-DRG system.

  3. Rheumatology training experience across Europe: analysis of core competences.

    Science.gov (United States)

    Sivera, Francisca; Ramiro, Sofia; Cikes, Nada; Cutolo, Maurizio; Dougados, Maxime; Gossec, Laure; Kvien, Tore K; Lundberg, Ingrid E; Mandl, Peter; Moorthy, Arumugam; Panchal, Sonia; da Silva, José A P; Bijlsma, Johannes W

    2016-09-23

    The aim of this project was to analyze and compare the educational experience in rheumatology specialty training programs across European countries, with a focus on self-reported ability. An electronic survey was designed to assess the training experience in terms of self-reported ability, existence of formal education, number of patients managed and assessments performed during rheumatology training in 21 core competences including managing specific diseases, generic competences and procedures. The target population consisted of rheumatology trainees and recently certified rheumatologists across Europe. The relationship between the country of training and the self-reported ability or training methods for each competence was analyzed through linear or logistic regression, as appropriate. In total 1079 questionnaires from 41 countries were gathered. Self-reported ability was high for most competences, range 7.5-9.4 (0-10 scale) for clinical competences, 5.8-9.0 for technical procedures and 7.8-8.9 for generic competences. Competences with lower self-reported ability included managing patients with vasculitis, identifying crystals and performing an ultrasound. Between 53 and 91 % of the trainees received formal education and between 7 and 61 % of the trainees reported limited practical experience (managing ≤10 patients) in each competence. Evaluation of each competence was reported by 29-60 % of the respondents. In adjusted multivariable analysis, the country of training was associated with significant differences in self-reported ability for all individual competences. Even though self-reported ability is generally high, there are significant differences amongst European countries, including differences in the learning structure and assessment of competences. This suggests that educational outcomes may also differ. Efforts to promote European harmonization in rheumatology training should be encouraged and supported.

  4. On-spot rheumatology consultations in a multilevel geriatric hospital.

    Science.gov (United States)

    Lubart, Emily; Leibovitz, Arthur; Shapir, Vadim; Segal, Refael

    2014-01-01

    Musculoskeletal and joint disorders are extremely common in the elderly. They directly affect mobility, gait stability, quality of life, and independence. To assess the nature of joint problems encountered in a geriatric inpatient population and evaluate the contribution of a rheumatologist. We reviewed the rheumatology consultation records that were conducted in a geriatric medical center over a 10 year period. A total of 474 consultations were held; most of these patients (86%) were hospitalized in the acute geriatric departments, 10% in the rehabilitation ward and 4% in the long-term care wards. Some patients were seen more than once. A rheumatologic joint problem was the main reason for hospitalization in 53% of these patients. Monoarthritis was the most frequent complaint (50%), followed by pauciarticular arthritis (two to five joints) in 30% of patients. Arthrocentesis, diagnostic and therapeutic, was performed in 225 patients, most of them in knee joints (81%). The most frequent diagnosis was osteoarthritis with acute exacerbation (28%), followed by gout (18%), pseudo-gout (9%) and rheumatoid arthritis (9%). In 86 cases (18%) the diagnosis was a non-specific rheumatologic problem: arthralgia, nonspecific generalized pain, or fibromyalgia. Prompt and appropriate evaluation, as well as arthrocentesis and treatment initiation, including local injections, were made possible by the presence of an in-house rheumatologist.

  5. Role of Tai Chi in the treatment of rheumatologic diseases.

    Science.gov (United States)

    Wang, Chenchen

    2012-12-01

    Rheumatologic diseases (e.g., fibromyalgia, osteoarthritis, and rheumatoid arthritis) consist of a complex interplay between biologic and psychological aspects, resulting in therapeutically challenging chronic conditions to control. Encouraging evidence suggests that Tai Chi, a multi-component Chinese mind-body exercise, has multiple benefits for patients with a variety of chronic disorders, particularly those with musculoskeletal conditions. Thus, Tai Chi may modulate complex factors and improve health outcomes in patients with chronic rheumatologic conditions. As a form of physical exercise, Tai Chi enhances cardiovascular fitness, muscular strength, balance, and physical function. It also appears to be associated with reduced stress, anxiety, and depression, as well as improved quality of life. Thus, Tai Chi can be safely recommended to patients with fibromyalgia, osteoarthritis, and rheumatoid arthritis as a complementary and alternative medical approach to improve patient well-being. This review highlights the current body of knowledge about the role of this ancient Chinese mind-body medicine as an effective treatment of rheumatologic diseases to better inform clinical decision-making for our patients.

  6. [Max Hirsch founder of rheumatology in Germany: banished and murdered].

    Science.gov (United States)

    Keitel, W

    2014-08-01

    The Jewish physician and scientist Dr. Max Hirsch (1875-1941) made a substantial contribution to consolidation of the foundations of his professional discipline, balneology, and in particular developed the social aspects. He recognized the economic significance of diseases of the musculoskeletal system very early on and gathered important ideas from abroad. Together with the department head in the Prussian Ministry of Education and Cultural Affairs, the Privy Councillor Prof. Dr. Eduard Dietrich and later alone, he was editor of various balneological journals. He worked as general secretary of the Deutsche Gesellschaft für Rheumatologie (German Society of Rheumatology) from the beginning of its existence (1927) and created the publication series Veröffentlichungen der Deutschen Gesellschaft für Rheumabekämpfung (Publications of the German Society against Rheumatism) and Rheuma-Jahrbuch (Annual review of rheumatology) in 1929, 1930 and 1931 and organized seven rheumatology congresses up to 1933. After the accession to power of the National Socialists, Max Hirsch and Eduard Dietrich were deposed from office. Hirsch emigrated to Latvia via Switzerland and the Soviet Union with his wife and one son where they were murdered in the course of the Jewish pogrom. The second son escaped with his family to Sweden.

  7. Musculoskeletal ultrasound in rheumatology in Korea: targeted ultrasound initiative survey.

    Science.gov (United States)

    Kang, Taeyoung; Wakefield, Richard J; Emery, Paul

    2016-04-01

    In collaboration with the Targeted Ultrasound Initiative (TUI), to conduct the first study in Korea to investigate current practices in ultrasound use among Korean rheumatologists. We translated the TUI Global Survey into Korean and added questions to better understand the specific challenges facing rheumatologists in Korea. To target as many rheumatologists in Korea as possible, we created an on-line version of this survey, which was conducted from March to April 2013. Rheumatologists are in charge of ultrasound in many Korean hospitals. Rheumatologists in hospitals and private clinics use ultrasound to examine between one and five patients daily; they use ultrasound for diagnosis more than monitoring and receive compensation of about US$30-50 per patient. There are marked differences in the rates of ultrasound usage between rheumatologists who work in private practice compared with tertiary hospitals. Korean rheumatologists not currently using ultrasound in their practice appear eager to do so. This survey provides important insights into the current status of ultrasound in rheumatology in Korea and highlights several priorities; specifically, greater provision of formal training, standardization of reporting and accrual of greater experience among ultrasound users. If these needs are addressed, all rheumatology departments in Korea are likely to use ultrasound or have access to it in the future. © 2014 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

  8. An audit of influenza and pneumococcal vaccination in rheumatology outpatients

    Directory of Open Access Journals (Sweden)

    Mitchell William S

    2007-07-01

    Full Text Available Abstract Background Influenza and pneumococcal vaccination are recommended for a number of clinical risk groups including patients treated with major immunosuppressant disease modifying anti-rheumatic drugs. Such immunisation is not only safe but immunogenic in patients with rheumatic diseases. We sought to establish dual vaccination rates and significant influencing factors amongst our hospital rheumatology outpatients. Method We audited a sample of 101 patients attending hospital rheumatology outpatient clinics on any form of disease modifying treatment by clinical questionnaire and medical record perusal. Further data were collected from the local immunisation coordinating agency and analysed by logistic regression modelling. Results Although there was a high rate of awareness with regard to immunisation, fewer patients on major immunosuppressants were vaccinated than patients with additional clinical risk factors against influenza (53% vs 93%, p Conclusion Influenza and pneumococcal immunisation is suboptimal amongst patients on current immunosuppressant treatments attending rheumatology outpatient clinics. Raising awareness amongst patients may not be sufficient to improve vaccination rates and alternative strategies such as obligatory pneumococcal vaccination prior to treatment initiation and primary care provider education need to be explored.

  9. [Pain in Spanish rheumatology outpatient offices: EPIDOR epidemiological study].

    Science.gov (United States)

    Gamero Ruiz, F; Gabriel Sánchez, R; Carbonell Abello, J; Tornero Molina, J; Sánchez-Magro, I

    2005-04-01

    To establish the prevalence and characteristics of rheumatologic pain in Spanish adult population cared in specialized rheumatology offices. Cross selection study in a population of patients cared in rheumatology offices of public Spanish hospitals. 1,134 patients selected through random sampling based on waiting lists of patients, during a period of 1 week, in rheumatology offices of each participating hospital. MAIN OUTCOMES OF THE STUDY: Reason behind the consultation (a new patient [NP] or a patient for revision [RP]), characteristics of the patient (sex, age, habits [alcohol/tobacco], marital status), location, type, intensity, duration, tolerance and management of pain; treatment (pharmacological or non-pharmacological) carried out; satisfaction with the treatment; and association with fibromyalgia. The prevalence of pain in NP was 98.6% and in RP 95.1%, with a global prevalence of 96%, predominating mainly in adult sedentary women with fibromyalgia. The frequency of acute pain was 20.9% and this of chronic pain 79.1% [corrected] The prevalence of fibromyalgia was 12% (2.2% in men, and 15.5% in women). The most prevalent pattern of current dominant pain was this of the mechanical type. More frequent associated pathologies were: hypertension (21.7%), depression (14.4%), gastrointestinal diseases (13.8%) and anxiety (13.4%). All variables analyzed in the study showed changes according to age, sex, and type of patient (NP or RP). Most used treatment was pharmacological; more than 57.6% of patients were receiving NSAIDs. In NP, medical prescriber of the treatment was first the general practitioner (56.1%) followed by the rheumatologist (14.1%); in PR the first one was the rheumatologist (69.9%) followed by the general practitioner (16.5%). Our results show that the prevalence of the rheumatologic pain is very high, predominating mainly in adult women with fibromyalgia. Pain location, intensity, and type, associated pathology, and treatment vary according to age

  10. Recruitment and retention of participants for an international type 1 diabetes prevention trial

    DEFF Research Database (Denmark)

    Franciscus, Margaret; Nucci, Anita; Bradley, Brenda

    2014-01-01

    for long-term follow-up assessments. PURPOSE: Our purpose is to summarize the recruitment and retention strategies used to conduct TRIGR from the perspective of the study coordinators. METHODS: TRIGR was designed to test whether weaning to formula containing hydrolyzed versus intact cow's milk protein......BACKGROUND: The Trial to Reduce Insulin Dependent Diabetes Mellitus in the Genetically at Risk (TRIGR) is the first multicenter international type 1 diabetes (T1D) prevention trial to be undertaken. A unique feature of TRIGR has been recruitment of eligible pregnant women and enrollment of newborns......-year follow-up phases of this study. The TRIGR study met the accrual goal after 4.7 years of recruitment, 2.7 years longer than projected initially. Challenges included difficulty in finding fathers with T1D, a higher than expected rate of premature delivery among T1D mothers, and implementation of new...

  11. Differences in reporting of analyses in internal company documents versus published trial reports: comparisons in industry-sponsored trials in off-label uses of gabapentin.

    Directory of Open Access Journals (Sweden)

    S Swaroop Vedula

    Full Text Available BACKGROUND: Details about the type of analysis (e.g., intent to treat [ITT] and definitions (i.e., criteria for including participants in the analysis are necessary for interpreting a clinical trial's findings. Our objective was to compare the description of types of analyses and criteria for including participants in the publication (i.e., what was reported with descriptions in the corresponding internal company documents (i.e., what was planned and what was done. Trials were for off-label uses of gabapentin sponsored by Pfizer and Parke-Davis, and documents were obtained through litigation. METHODS AND FINDINGS: For each trial, we compared internal company documents (protocols, statistical analysis plans, and research reports, all unpublished, with publications. One author extracted data and another verified, with a third person verifying discordant items and a sample of the rest. Extracted data included the number of participants randomized and analyzed for efficacy, and types of analyses for efficacy and safety and their definitions (i.e., criteria for including participants in each type of analysis. We identified 21 trials, 11 of which were published randomized controlled trials, and that provided the documents needed for planned comparisons. For three trials, there was disagreement on the number of randomized participants between the research report and publication. Seven types of efficacy analyses were described in the protocols, statistical analysis plans, and publications, including ITT and six others. The protocol or publication described ITT using six different definitions, resulting in frequent disagreements between the two documents (i.e., different numbers of participants were included in the analyses. CONCLUSIONS: Descriptions of analyses conducted did not agree between internal company documents and what was publicly reported. Internal company documents provide extensive documentation of methods planned and used, and trial

  12. The International (Ludwig) Breast Cancer Study Group Trials I-IV: 15 years follow-up.

    Science.gov (United States)

    Castiglione-Gertsch, M; Johnsen, C; Goldhirsch, A; Gelber, R D; Rudenstam, C M; Collins, J; Lindtner, J; Hacking, A; Cortes-Funes, H; Forbes, J

    1994-10-01

    Adjuvant systemic therapy prolongs disease-free and overall survival in both pre- and postmenopausal patients. Available data shown benefit from multi-agent chemotherapy, prolonged tamoxifen treatment, and ovarian ablation, and that the combination of chemo- and endocrine therapy might be advantageous. In 1978 the International (Ludwig) Breast Cancer Study Group (IBCSG) initiated four complementary randomized controlled clinical trials to evaluate the roles of chemo-endocrine combinations or endocrine therapy alone in specific populations defined by risk (for pre- and perimenopausal patients) or by age (for postmenopausal patients). The results at 10 and 13 years' median follow-up for these trials are summarized in this report and are compared to those of the Overview meta-analysis with regard to chemo-endocrine or endocrine therapy combinations. Furthermore, types of first relapses by sites and second malignant diseases are reported. 1601 evaluable patients with node positive disease were included into the studies I-IV. In Trial I (491 premenopausal patients with 1-3 positive axillary nodes) we studied the addition of low-dose continuous prednisone (p) to a cyclophosphamide-methotrexate-fluorouracil (CMF) combination. In Trial II 327 premenopausal patients with four or more positive axillary nodes were randomized to one year CMFp or to a surgical oophorectomy followed by CMFp. In Trial III (463 postmenopausal patients 65 years old or younger), combined chemoendocrine therapy (one year of CMFp plus tamoxifen (T)) was compared to endocrine therapy (1 year of p + T) or to surgery alone. In Trial IV 320 postmenopausal patients 66 to 80 years old were treated either by surgery alone or by surgery followed by 1 year prednisone and tamoxifen. In Trial I the addition of prednisone allowed a higher dose of cytotoxics to be administered compared with CMF alone. Despite this increased dose intensity, 13-year disease-free survival (DFS) and overall survival (OS) were similar

  13. Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform

    Directory of Open Access Journals (Sweden)

    S. Kannan

    2016-03-01

    Conclusion: The number of clinical trials done in allied fields of medicine other than the allopathic system has lowered down, and furthermore focus is required regarding the methodological quality of these trials and more support from various organizations.

  14. International Geographic Variation in Event Rates in Trials of Heart Failure With Preserved and Reduced Ejection Fraction

    DEFF Research Database (Denmark)

    Kristensen, Søren L; Køber, Lars; Jhund, Pardeep S

    2015-01-01

    BACKGROUND: International geographic differences in outcomes may exist for clinical trials of heart failure and reduced ejection fraction (HF-REF), but there are few data for those with preserved ejection fraction (HF-PEF). METHODS AND RESULTS: We analyzed outcomes by international geographic reg...

  15. Challenges and Opportunities in Using Patient-Reported Outcomes in Quality Measurement in Rheumatology

    OpenAIRE

    Wahl, Elizabeth; Yazdany, Jinoos

    2016-01-01

    Use of Patient-reported outcome measures (PROs) in rheumatology research is widespread, but use of PRO data to evaluate the quality of rheumatologic care delivered is less well established. This article reviews the use of PROs in assessing healthcare quality, and highlights challenges and opportunities specific to their use in rheumatology quality measurement. We first explore other countries’ experiences collecting and evaluating national PRO data to assess quality of care. We describe the c...

  16. An audit of influenza and pneumococcal vaccination in rheumatology outpatients.

    Science.gov (United States)

    Sowden, Evin; Mitchell, William S

    2007-07-04

    Influenza and pneumococcal vaccination are recommended for a number of clinical risk groups including patients treated with major immunosuppressant disease modifying anti-rheumatic drugs. Such immunisation is not only safe but immunogenic in patients with rheumatic diseases. We sought to establish dual vaccination rates and significant influencing factors amongst our hospital rheumatology outpatients. We audited a sample of 101 patients attending hospital rheumatology outpatient clinics on any form of disease modifying treatment by clinical questionnaire and medical record perusal. Further data were collected from the local immunisation coordinating agency and analysed by logistic regression modelling. Although there was a high rate of awareness with regard to immunisation, fewer patients on major immunosuppressants were vaccinated than patients with additional clinical risk factors against influenza (53% vs 93%, p risk factors was confirmed as significant in determining vaccination status by logistic regression for both influenza (OR 10.89, p < 0.001) and streptococcus pneumoniae (OR 4.55, p = 0.002). The diagnosis of rheumatoid arthritis was also found to be a significant factor for pneumococcal vaccination (OR 5.1, p = 0.002). There was a negative trend suggesting that patients on major immunosuppressants are less likely to be immunised against pneumococcal antigen (OR 0.35, p = 0.067). Influenza and pneumococcal immunisation is suboptimal amongst patients on current immunosuppressant treatments attending rheumatology outpatient clinics. Raising awareness amongst patients may not be sufficient to improve vaccination rates and alternative strategies such as obligatory pneumococcal vaccination prior to treatment initiation and primary care provider education need to be explored.

  17. Case mix in paediatric rheumatology: implications for training in Australia.

    Science.gov (United States)

    Lim, Sern Chin; Allen, Roger C; Munro, Jane E; Akikusa, Jonathan D

    2012-05-01

    Despite a move towards the provision of specialist training in Australia in settings that extend beyond the public hospital system, formal comparisons of case mix between public and private specialty clinics have rarely been performed. It is therefore unclear for many specialties how well training in one setting prepares trainees for practice in the other. This study aims to compare the case mix of paediatric rheumatology patients seen in public and private settings and the referral sources of patients in each. An audit of all new patients seen in the public and private paediatric rheumatology clinics on campus at Royal Children's Hospital between June 2009 and January 2011. Data related to demographics, primary diagnosis, referral source and location seen were abstracted and compared. Eight hundred and seventy-six new patients were seen during the period of interest. Of these, 429 patients (48.9%) were seen in private clinics. The commonest diagnostic categories for both type of clinics were non-inflammatory musculoskeletal pain/orthopaedic conditions (public 39.4%, private 33.6%) followed by juvenile idiopathic arthritis (public 16.6%, %, private 18.6%), other skin/soft tissue disorders (public 8.7%, private 9.6%) and pain syndromes (public 4.9%, private 11.4%). Patients with haematological and vasculitic disorders were predominantly seen in public clinics. The commonest source of referrals to both clinics was general practitioners (public 40.6%, private 53.1%). The case mix in private paediatric rheumatology clinics closely mirrors that of public clinics at our centre. Training in either setting would provide sufficient case-mix exposure to prepare trainees for practice in the other. © 2011 The Authors. Journal of Paediatrics and Child Health © 2011 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

  18. Analysis and Thoughts about the Negative Results of International Clinical Trials on Acupuncture

    Science.gov (United States)

    Han, Yan-jing; Wang, Xiao-hong; Li, Chen; Liu, Wan-ning

    2015-01-01

    An increasing number of randomized controlled trials (RCTs) of acupuncture have proved the clinical benefits of acupuncture; however, there are some results that have shown negative results or placebo effects. The paper carried out an in-depth analysis on 33 RCTs in the 2011 SCI database, the quality of the reports was judged according to Jadad scores, and the “Necessary Information Included in Reporting Interventions in Clinical Trials of Acupuncture (STRICTA 2010)” was taken as the standard to analyze the rationality of the therapeutic principle. The difference between the methodology (Jadad) scores of the two types of research reports did not constitute statistical significance (P > 0.05). The studies with negative results or placebo effects showed the following deficiencies with respect to intervention details: (1) incompletely rational acupoint selection; (2) inconsistent ability of acupuncturists; (3) negligible needling response to needling; (4) acupuncture treatment frequency too low in most studies; and (5) irrational setting of placebo control. Thus, the primary basis for the negative results or placebo effects of international clinical trials on acupuncture is not in the quality of the methodology, but in noncompliance with the essential requirements proposed by acupuncture theory in terms of clinical manipulation details. PMID:26161126

  19. Modern psychometrics applied in rheumatology--a systematic review.

    Science.gov (United States)

    Siemons, Liseth; Ten Klooster, Peter M; Taal, Erik; Glas, Cees Aw; Van de Laar, Mart Afj

    2012-10-31

    Although item response theory (IRT) appears to be increasingly used within health care research in general, a comprehensive overview of the frequency and characteristics of IRT analyses within the rheumatic field is lacking. An overview of the use and application of IRT in rheumatology to date may give insight into future research directions and highlight new possibilities for the improvement of outcome assessment in rheumatic conditions. Therefore, this study systematically reviewed the application of IRT to patient-reported and clinical outcome measures in rheumatology. Literature searches in PubMed, Scopus and Web of Science resulted in 99 original English-language articles which used some form of IRT-based analysis of patient-reported or clinical outcome data in patients with a rheumatic condition. Both general study information and IRT-specific information were assessed. Most studies used Rasch modeling for developing or evaluating new or existing patient-reported outcomes in rheumatoid arthritis or osteoarthritis patients. Outcomes of principle interest were physical functioning and quality of life. Since the last decade, IRT has also been applied to clinical measures more frequently. IRT was mostly used for evaluating model fit, unidimensionality and differential item functioning, the distribution of items and persons along the underlying scale, and reliability. Less frequently used IRT applications were the evaluation of local independence, the threshold ordering of items, and the measurement precision along the scale. IRT applications have markedly increased within rheumatology over the past decades. To date, IRT has primarily been applied to patient-reported outcomes, however, applications to clinical measures are gaining interest. Useful IRT applications not yet widely used within rheumatology include the cross-calibration of instrument scores and the development of computerized adaptive tests which may reduce the measurement burden for both the patient

  20. [The G-DRG System 2009--relevant changes for rheumatology].

    Science.gov (United States)

    Fiori, W; Liedtke-Dyong, A; Lakomek, H-J; Buscham, K; Lehmann, H; Liman, W; Fuchs, A-K; Bessler, F; Roeder, N

    2010-05-01

    The following article presents the major general and specific changes in the G-DRG system, in the classification systems for diagnoses and procedures as well as for the billing process for 2010. Since the G-DRG system is primarily a tool for the redistribution of resources, every hospital needs to analyze the economic effects of the changes by applying the G-DRG transition-grouper to its own cases. Depending on their clinical focus, rheumatological departments may experience positive or negative consequences from the adjustments. In addition, relevant current case law is considered.

  1. Value of 3-dimensional (3D) imaging in rheumatology

    International Nuclear Information System (INIS)

    Fredy, D.

    1990-01-01

    The whole body scanner (Exel 2.400) of the Centre Hospitalier Sainte-Anne enables the three-dimensional reconstruction, with visualization, of the object in its real volume in less than 10 minutes after taking 20 to 40 radiological sections. The exploration can be complete at all levels. Bone lesions can be perfectly shown, the study of osteoarticular or intraspinal abnormalities is facilitated, all solution of continuity can be detected. A soft parts program as well as a colour program enable a clear and rapid visualization of organic lesions. Three-dimensional imaging can be of great value in rheumatology [fr

  2. Rheumatologic complications in a cohort of 227 patients with common variable immunodeficiency.

    Science.gov (United States)

    Azizi, G; Kiaee, F; Hedayat, E; Yazdani, R; Dolatshahi, E; Alinia, T; Sharifi, L; Mohammadi, H; Kavosi, H; Jadidi-Niaragh, F; Ziaee, V; Abolhassani, H; Aghamohammadi, A

    2018-05-01

    Common variable immunodeficiency (CVID) is the most prevalent symptomatic type of human primary immunodeficiency diseases (PID). Clinically, CVID is characterized by increased susceptibility to infections and a wide variety of autoimmune and rheumatologic disorders. All patients with CVID registered in Iranian PID Registry (IPIDR) were enrolled in this retrospective cohort study. We investigated the frequency of rheumatologic diseases and its association with immunological and clinical phenotypes in patients with CVID. A total of 227 patients with CVID were enrolled in this study. The prevalence of rheumatologic disorders was 10.1% with a higher frequency in women than men. Most common rheumatologic manifestations were juvenile idiopathic arthritis (JIA) and adult rheumatoid arthritis (RA) followed by juvenile spondyloarthritis (JSpA) and undifferentiated inflammatory arthritis (UIA). Septic arthritis in patients with CVID with a history of RA and JIA was higher than patients without rheumatologic complication. Patients with CVID with a history of autoimmunity (both rheumatologic and non-rheumatologic autoimmunity) had lower regulatory T cells counts in comparison with patients without autoimmune disorders. There was an association between defect in specific antibody responses and negative serologic test results in patients with rheumatologic manifestations. JIA, RA, JSpA and UIA are the most frequent rheumatologic disorders in patients with CVID. Due to antibody deficiency, serologic tests may be negative in these patients. Therefore, these conditions pose significant diagnostic and therapeutic challenges for immunologists and rheumatologists in charge of the care for these patients. © 2018 The Foundation for the Scandinavian Journal of Immunology.

  3. An internal pilot design for prospective cancer screening trials with unknown disease prevalence.

    Science.gov (United States)

    Brinton, John T; Ringham, Brandy M; Glueck, Deborah H

    2015-10-13

    For studies that compare the diagnostic accuracy of two screening tests, the sample size depends on the prevalence of disease in the study population, and on the variance of the outcome. Both parameters may be unknown during the design stage, which makes finding an accurate sample size difficult. To solve this problem, we propose adapting an internal pilot design. In this adapted design, researchers will accrue some percentage of the planned sample size, then estimate both the disease prevalence and the variances of the screening tests. The updated estimates of the disease prevalence and variance are used to conduct a more accurate power and sample size calculation. We demonstrate that in large samples, the adapted internal pilot design produces no Type I inflation. For small samples (N less than 50), we introduce a novel adjustment of the critical value to control the Type I error rate. We apply the method to two proposed prospective cancer screening studies: 1) a small oral cancer screening study in individuals with Fanconi anemia and 2) a large oral cancer screening trial. Conducting an internal pilot study without adjusting the critical value can cause Type I error rate inflation in small samples, but not in large samples. An internal pilot approach usually achieves goal power and, for most studies with sample size greater than 50, requires no Type I error correction. Further, we have provided a flexible and accurate approach to bound Type I error below a goal level for studies with small sample size.

  4. The FINISH-3 Trial : A Phase 3, International, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps in Intraoperative Surgical Hemostasis

    NARCIS (Netherlands)

    Bochicchio, Grant V.; Gupta, Navyash; Porte, Robert J.; Renkens, Kenneth L.; Pattyn, Piet; Topal, Baki; Troisi, Roberto Ivan; Muir, William; Chetter, Ian; Gillen, Daniel L.; Zuckerman, Linda A.; Frohna, Paul A.

    BACKGROUND: This Phase 3, international, randomized, single-blind, controlled trial (FINISH-3) compared the efficacy and safety of Fibrocaps, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen, vs gelatin sponge alone for use as a hemostat for surgical

  5. Leprae reaction resembling rheumatologic disease as presenting feature of leprosy.

    Science.gov (United States)

    Baharuddin, Hazlyna; Taib, Tarita; Zain, Mollyza Mohd; Ch'ng, Shereen

    2016-10-01

    Leprosy is a chronic granulomatous infection caused by Mycobacterium leprae with predominant involvement of skin and nerves. We present a 70-year-old man with leprosy whose initial presentation resembled rheumatologic disease, due to leprae reaction. He presented with an 8-week history of worsening neuropathic pain in the right forearm, associated with necrotic skin lesions on his fingers that had ulcerated. Physical examination revealed two tender necrotic ulcers at the tip of the right middle finger and the dorsal aspect of the left middle finger. The patient had right wrist tenosynovitis and right elbow bursitis. Apart from raised inflammatory markers, the investigations for infection, connective tissue disease, vasculitis, thromboembolic disease and malignancy were negative. During the fourth week of hospitalization, we noticed a 2-cm hypoesthetic indurated plaque on the right inner arm. Further examination revealed thickened bilateral ulnar, radial and popliteal nerves. A slit skin smear was negative. Two skin biopsies and a biopsy of the olecranon bursa revealed granulomatous inflammation. He was diagnosed with paucibacillary leprosy with neuritis. He responded well to multidrug therapy and prednisolone; his symptoms resolved over a few weeks. This case illustrates the challenges in diagnosing a case of leprosy with atypical presentation in a non-endemic country. © 2016 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

  6. [Changes for rheumatology in the G-DRG system 2005].

    Science.gov (United States)

    Fiori, W; Roeder, N; Lakomek, H-J; Liman, W; Köneke, N; Hülsemann, J L; Lehmann, H; Wenke, A

    2005-02-01

    The German prospective payment system G-DRG has been recently adapted and recalculated. Apart from the adjustments of the G-DRG classification system itself changes in the legal framework like the extension of the "convergence period" or the limitation of budget loss due to DRG introduction have to be considered. Especially the introduction of new procedure codes (OPS) describing the specialized and complex rheumatologic treatment of inpatients might be of significant importance. Even though these procedures will not yet develop influence on the grouping process in 2005, it will enable a more accurate description of the efforts of acute-rheumatologic treatment which can be used for further adaptations of the DRG algorithm. Numerous newly introduced additive payment components (ZE) result in a more adequate description of the "DRG-products". Although not increasing the individual hospital budget, these additive payments contribute to more transparency of high cost services and can be addressed separately from the DRG-budget. Furthermore a lot of other relevant changes to the G-DRG catalogue, the classification systems ICD-10-GM and OPS-301 and the German Coding Standards (DKR) are presented.

  7. Antibody Response against Parvovirus in Patients with Inflammatory Rheumatological Diseases

    Directory of Open Access Journals (Sweden)

    SH Raeisi

    2011-07-01

    Full Text Available Introduction: Some viral infections have been suggested to trigger or cause autoimmune diseases. One of these viruses is parvovirus B19 which can have various rheumatologic manifestations. In this study we investigated the association between parvovirus and rheumatoid arthritis (RA, systemic lupus erythematosis(SLE, systemic sclerosis(SSc and undifferentiated arthritis at the Rheumatological Clinic, Imam Khomeini hospital. Methods: In this sectional case-control study, IgM and IgG antibodies against parvovirus B19 were measured with ELISA in 41 patients with RA, 28 patients with SLE, 13 patients with SSc, 8 patients with undifferentiated arthritis as well as 90 healthy controls. The ELISA kit (DRG, Germany was semi-quantitative and qualititative. Results: Parvovirus B19 IgM was detected in one patient with RA, one with SSc and four in the control group. IgG anti- B19-specific antibody was detected in 58.5% of RA patients, 67.9% of SLE patients, 69. 2% of SSc patients, 87.5% of undifferentiated arthritis patients as compared to 53.3% of controls. The results were compared between the patient and control groups(p>0.05. Conclusion: According to the results, there was no significant correlation for the antibody titer against parvovirus B19 in the patient and control group. The highly positive response of IgG against parvovirus in undifferentiated arthritis implies the need for more research.

  8. Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME)

    Science.gov (United States)

    Chalmers, JR; Schmitt, J; Apfelbacher, C; Dohil, M; Eichenfield, LF; Simpson, EL; Singh, J; Spuls, P; Thomas, KS; Admani, S; Aoki, V; Ardeleanu, M; Barbarot, S; Berger, T; Bergman, JN; Block, J; Borok, N; Burton, T; Chamlin, SL; Deckert, S; DeKlotz, CC; Graff, LB; Hanifin, JM; Hebert, AA; Humphreys, R; Katoh, N; Kisa, RM; Margolis, DJ; Merhand, S; Minnillo, R; Mizutani, H; Nankervis, H; Ohya, Y; Rodgers, P; Schram, ME; Stalder, JF; Svensson, A; Takaoka, R; Teper, A; Tom, WL; von Kobyletzki, L; Weisshaar, E; Zelt, S; Williams, HC

    2014-01-01

    Summary This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6–7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial: clinical signs, patient-reported symptoms, long-term control and quality of life. Formal presentations and nominal group techniques were used at this working meeting, attended by 56 voting participants (31 of whom were dermatologists). Significant progress was made on the domain of clinical signs. Without reference to any named scales, it was agreed that the intensity and extent of erythema, excoriation, oedema/papulation and lichenification should be included in the core outcome measure for the scale to have content validity. The group then discussed a systematic review of all scales measuring the clinical signs of eczema and their measurement properties, followed by a consensus vote on which scale to recommend for inclusion in the core outcome set. Research into the remaining three domains was presented, followed by discussions. The symptoms group and quality of life groups need to systematically identify all available tools and rate the quality of the tools. A definition of long-term control is needed before progress can be made towards recommending a core outcome measure. What's already known about this topic? Many different scales have been used to measure eczema, making it difficult to compare trials in meta-analyses and hampering improvements in clinical practice. HOME core outcome measures must pass the OMERACT (Outcome Measures in Rheumatology) filter of truth (validity), discrimination (sensitivity to change and responsiveness) and feasibility (ease of use, costs, time to perform and interpret). It has been previously agreed as part of the consensus process that four domains should be measured by the core outcomes: clinical signs, patient

  9. [Arthur Vick Prize 2017 of the German Society of Orthopaedic Rheumatology].

    Science.gov (United States)

    Bause, L; Niemeier, A; Krenn, V

    2018-03-01

    The German Society of Orthopaedic Rheumatology (DGORh) honored Prof. Dr. med. Veit Krenn (MVZ-ZHZMD-Trier) with the Arthur Vick Prize 2017. With this award, scientific results with high impact on the diagnosis, therapy and pathogenetic understanding of rheumatic diseases are honored. In cooperation with pathologists and colleagues from various clinical disciplines Prof. Dr. med. Veit Krenn developed several histopathologic scoring systems which contribute to the diagnosis and pathogenetic understanding of degenerative and rheumatic diseases. These scores include the synovitis score, the meniscal degeneration score, the classification of periprosthetic tissues (SLIM classification), the arthrofibrosis score, the particle score and the CD15 focus score. Of highest relevance for orthopedic rheumatology is the synovitis score which is a semiquantitative score for evaluating immunological and inflammatory changes of synovitis in a graded manner. Based on this score, it is possible to divide results into low-grade synovitis and high-grade synovitis: a synovitis score of 1-4 is called low-grade synovitis and occurs for example in association with osteoarthritis (OA), post-trauma, with meniscal lesions and hemochromatosis. A synovitis score of 5-9 is called high-grade synovitis, e.g. rheumatoid arthritis, psoriatic arthritis, Lyme arthritis, postinfection and reactive arthritis as well as peripheral arthritis with Bechterew's disease (sensitivity 61.7%, specificity 96.1%). The first publication (2002) and an associated subsequent publication (2006) of the synovitis score has led to national and international acceptance of this score as the standard for histopathological assessment of synovitis. The synovitis score provides a diagnostic, standardized and reproducible histopathological evaluation method for joint diseases, particularly when this score is applied in the context with the joint pathology algorithm.

  10. Use of vitamin D supplements during infancy in an international feeding trial

    DEFF Research Database (Denmark)

    Lehtonen, Eveliina; Ormisson, Anne; Nucci, Anita

    2014-01-01

    OBJECTIVE: To examine the use of vitamin D supplements during infancy among the participants in an international infant feeding trial. DESIGN: Longitudinal study. SETTING: Information about vitamin D supplementation was collected through a validated FFQ at the age of 2 weeks and monthly between...... supplements was common during the first 6 months of life in Northern and Central Europe (>80% of the infants), with somewhat lower rates observed in Southern Europe (> 60%). In Canada, vitamin D supplementation was more common among exclusively breast-fed than other infants (e.g., 71% v. 44% at 6 months...... of age). Less than 2% of infants in the U.S.A. and Australia received any vitamin D supplementation. Higher gestational age, older maternal age and longer maternal education were study-wide associated with greater use of vitamin D supplements. CONCLUSIONS: Most of the infants received vitamin D...

  11. The EULAR Scleroderma Trials and Research Group (EUSTAR): an international framework for accelerating scleroderma research.

    Science.gov (United States)

    Tyndall, Alan; Ladner, Ulf M; Matucci-Cerinic, Marco

    2008-11-01

    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.

  12. [Nailfold capillaroscopy: relevance to the practice of rheumatology].

    Science.gov (United States)

    Souza, Eduardo José do Rosário E; Kayser, Cristiane

    2015-01-01

    Nailfold capillaroscopy is a simple, low-cost method, that is extremely important in the evaluation of patients with Raynaud's phenomenon and of patients with systemic sclerosis (SSc) spectrum diseases. Besides its importance for the early diagnosis of SSc, nailfold capillaroscopy is a useful tool to identify scleroderma patients with high risk for development of vascular and visceral complications and death. The inclusion of capillaroscopy in the new classification criteria for SSc of the American College of Rheumatology (ACR) and European League Against Rheumatism (Eular) gives a new impetus to the use and dissemination of the method. In this paper, we present a didactic, non-systematic review on the subject, with emphasis on advances recently described. Copyright © 2014 Elsevier Editora Ltda. All rights reserved.

  13. Readability of patient information and consent documents in rheumatological studies

    DEFF Research Database (Denmark)

    Hamnes, Bente; van Eijk-Hustings, Yvonne; Primdahl, Jette

    2016-01-01

    BACKGROUND: Before participation in medical research an informed consent must be obtained. This study investigates whether the readability of patient information and consent documents (PICDs) corresponds to the average educational level of participants in rheumatological studies in the Netherlands......, Denmark, and Norway. METHODS: 24 PICDs from studies were collected and readability was assessed independently using the Gunning's Fog Index (FOG) and Simple Measure of Gobbledygook (SMOG) grading. RESULTS: The mean score for the FOG and SMOG grades were 14.2 (9.0-19.0) and 14.2 (12-17) respectively....... The mean FOG and SMOG grades were 12.7 and 13.3 in the Dutch studies, 15.0 and 14.9 in the Danish studies, and 14.6 and 14.3 in the Norwegian studies, respectively. Out of the 2865 participants, more than 57 % had a lower educational level than the highest readability score calculated in the individual...

  14. Rheumatoid cachexia and other nutritional alterations in rheumatologic diseases.

    Science.gov (United States)

    Hurtado-Torres, Gilberto Fabián; González-Baranda, Lourdes Larisa; Abud-Mendoza, Carlos

    2015-01-01

    The prevalence of nutritional alterations in rheumatologic diseases ranges from 4 to 95%, depending on the detection method used. Formerly described as the single term rheumatoid cachexia, nutritional alterations can currently be grouped and subdivided based on the physiopathological mechanisms involved: chronic disease-related inflammatory conditions (cachexia), malnutrition associated to acute malnutrition inflammatory conditions (protein-caloric malnutrition) and starvation-related malnutrition. Clinical manifestations of malnutrition associated to rheumatic diseases vary from the patient with low weight or overweight and obesity; with lean body mass depletion as well as functional repercussions, and impact of quality of life as a common denominator. Additionally, the associated increase in body fat mass increases the risk for cardiovascular morbidity. A multidisciplinary approach towards rheumatic diseases should include aspects oriented towards prevention, early identification, diagnosis and correction of nutritional alterations. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

  15. Fit for work? Evaluation of a workshop for rheumatology teams.

    Science.gov (United States)

    Cohen, D; Khan, S; Marfell, N

    2016-06-01

    People with rheumatoid arthritis (RA) may rapidly cease work prematurely due to ill-health. A recent survey noted that a quarter of respondents with RA experienced job loss within a year of diagnosis and 50% stopped work within 6 years. To develop and pilot workshops to increase the knowledge, skills and confidence of rheumatology team members to support work-related issues in outpatient clinics. A 3-h interactive workshop, informed by rheumatology experts and the Royal College of General Practitioners (RCGP) National Education Programme (NEP) about work and health, was developed to address both knowledge and skills in the management of health and work consultations in an outpatient setting. Questionnaires were developed for use pre- and immediately post-workshop, with questions that focused on the confidence of delegates in managing these discussions and the importance they placed upon them. Ninety-nine participants attended five workshops throughout the UK between 2013 and 2104. Seventy-three per cent (72) completed the post-workshop questionnaire. Eighty-nine per cent found the workshop useful or very useful, 88% found it relevant or very relevant and 79% responded that it had an impact or a considerable impact on their practice. Wilcoxon matched pairs signed rank tests were carried out that showed an overall increase in confidence after training. The results suggest that the workshop was both relevant and useful to participants and had an impact on their practice. This was true for all specialities. The workshops also highlighted participants' desire to understand how to use the 'fit note' to enhance their patient management. © The Author 2015. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  16. Predictors of employment for people with severe mental illness : results of an international six-centre randomised controlled trial

    NARCIS (Netherlands)

    Catty, Jocelyn; Lissouba, Pascale; White, Sarah; Becker, Thomas; Drake, Robert E.; Fioritti, Angelo; Knapp, Martin; Lauber, Christoph; Roessler, Wulf; Tomov, Toma; Van Busschbach, Jooske; Wiersma, Durk; Burns, Tom; Rossler, W.

    Background An international six-centre randomised controlled trial comparing individual placement and support (IPS) with usual vocational rehabilitation for people with serious mental illness found IPS to be more effective for all vocational outcomes. Aims To determine which patients with severe

  17. International Subarachnoid Aneurysm Trial 2009 : Endovascular Coiling of Ruptured Intracranial Aneurysms Has No Significant Advantage Over Neurosurgical Clipping

    NARCIS (Netherlands)

    Bakker, Nicolaas A.; Metzemaekers, Jan D. M.; Groen, Rob J. M.; Mooij, Jan Jakob A.; Van Dijk, J. Marc C.

    In the May 2009 issue of The Lancet Neurology, the 5-year follow-up results of the International Subarachnoid Aneurysm Trial (ISAT) were published. The authors concluded that, although the significant difference between coiling and neurosurgical clipping of ruptured intracranial aneurysms in terms

  18. Sentinel node biopsy for early-stage melanoma - Accuracy and morbidity in MSLT-I, an international multicenter trial

    NARCIS (Netherlands)

    Morton, DL; Cochran, AJ; Thompson, JF; Elashoff, R; Essner, R; Glass, EC; Mozzillo, N; Nieweg, OE; Roses, DF; Hoekstra, HJ; Karakousis, CP; Reintgen, DS; Coventry, BJ; Wang, HJ

    Objective:The objective of this study was to evaluate, in an international multicenter phase III trial, the accuracy, use, and morbidity of intraoperative lymphatic mapping and sentinel node biopsy (LM/SNB) for staging the regional nodal basin of patients with early-stage melanoma. Summary

  19. Evaluation of internal peer-review to train nurses recruiting to a randomized controlled trial--Internal Peer-review for Recruitment Training in Trials (InterPReTiT).

    Science.gov (United States)

    Mann, Cindy; Delgado, Debbie; Horwood, Jeremy

    2014-04-01

    A discussion and qualitative evaluation of the use of peer-review to train nurses and optimize recruitment practice in a randomized controlled trial. Sound recruitment processes are critical to the success of randomized controlled trials. Nurses recruiting to trials must obtain consent for an intervention that is administered for reasons other than anticipated benefit to the patient. This requires not only patients' acquiescence but also evidence that they have weighed the relevant information in reaching their decision. How trial information is explained is vital, but communication and training can be inadequate. A discussion of a new process to train nurses recruiting to a randomized controlled trial. Literature from 1999-2013 about consenting to trials is included. Over 3 months from 2009-2010, recruiting nurses reviewed recruitment interviews recorded during the pilot phase of a single-site randomized controlled trial and noted content, communication style and interactions. They discussed their findings during peer-review meetings, which were audio-recorded and analysed using qualitative methodology. Peer-review can enhance nurses' training in trial recruitment procedures by supporting development of the necessary communication skills, facilitating consistency in information provision and sharing best practice. Nurse-led peer-review can provide a forum to share communication strategies that will elicit and address participant concerns and obtain evidence of participant understanding prior to consent. Comparing practice can improve consistency and accuracy of trial information and facilitate identification of recruitment issues. Internal peer-review was well accepted and promoted team cohesion. Further evaluation is needed. © 2013 John Wiley & Sons Ltd.

  20. Structured patient handoff on an internal medicine ward: A cluster randomized control trial.

    Science.gov (United States)

    Tam, Penny; Nijjar, Aman P; Fok, Mark; Little, Chris; Shingina, Alexandra; Bittman, Jesse; Raghavan, Rashmi; Khan, Nadia A

    2018-01-01

    The effect of a multi-faceted handoff strategy in a high volume internal medicine inpatient setting on process and patient outcomes has not been clearly established. We set out to determine if a multi-faceted handoff intervention consisting of education, standardized handoff procedures, including fixed time and location for face-to-face handoff would result in improved rates of handoff compared with usual practice. We also evaluated resident satisfaction, health resource utilization and clinical outcomes. This was a cluster randomized controlled trial in a large academic tertiary care center with 18 inpatient internal medicine ward teams from January-April 2013. We randomized nine inpatient teams to an intervention where they received an education session standardizing who and how to handoff patients, with practice and feedback from facilitators. The control group of 9 teams continued usual non-standardized handoffs. The primary process outcome was the rate of patients handed over per 1000 patient nights. Other process outcomes included perceptions of inadequate handoff by overnight physicians, resource utilization overnight and hospital length of stay. Clinical outcomes included medical errors, frequency of patients requiring higher level of care overnight, and in-hospital mortality. The intervention group demonstrated a significant increase in the rate of patients handed over to the overnight physician (62.90/1000 person-nights vs. 46.86/1000 person-nights, p = 0.002). There was no significant difference in other process outcomes except resource utilization was increased in the intervention group (26.35/1000 person-days vs. 17.57/1000 person-days, p-value = 0.01). There was no significant difference between groups in medical errors (4.8% vs. 4.1%), need for higher level of care or in hospital mortality. Limitations include a dependence of accurate record keeping by the overnight physician, the possibility of cross-contamination in the handoff process, analysis at

  1. THE EUROPEAN CONGRESS OF RHEUMATOLOGY (PARIS, 11–14 JUNE 2014: PROBLEMS OF RHEUMATOID ARTHRITIS

    Directory of Open Access Journals (Sweden)

    A. S. Avdeeva

    2014-01-01

    Full Text Available The 15th annual European Congress of Rheumatology took place in Paris in June 2014. Its program was extremely diverse and included a discussion of new data pertinent to the diagnosis and treatment of the most common rheumatic diseases and problems of their etiology and pathogenesis, personified therapy, and many others. The Congress focused on the problems of early rheumatoid arthritis (RA. A number of papers concerned the efficiency and safety of different therapy regimens for RA at its onset, the discontinuation of biological therapy after achievement of remission, and the maintenance of drug-free RA remission. The Congress discussed new results of the tREACH trial comparing three treatment regimens for early inflammatory arthritis: combined therapy with methotrexate (MT, sulfasalazine, and hydroxychloroquine in conjunction with intramuscular glucocorticoids (GC; combined therapy with these drugs in conjunction with oral GC; and MT monotherapy with oral GC. A large number of reports dealt with the use of tumor necrosis factor-α inhibitors, the evaluation of their immunogenicity, and theanalysis of reasons for therapy discontinuation and adverse reactions. Some aspects of therapy with disease-difying antirheumatic drugs were discussed. A number of reports concerned the application of novel laboratory biomarkers for RA.Thus, sufficiently many new data that will be able to optimize therapy for common rheumatic disease, such as RA, were presented at the Congress.

  2. AntiPhospholipid Syndrome Alliance for Clinical Trials and InternatiOnal Networking (APS ACTION): 5-Year Update.

    Science.gov (United States)

    Barbhaiya, Medha; Andrade, Danieli; Erkan, Doruk

    2016-10-01

    Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) is the first-ever international network created to design and conduct large-scale, multicenter clinical trials and research in persistently antiphospholipid antibody (aPL)-positive patients. Since its inception in 2010, the APS ACTION has made important strides toward our goal of international research collaboration and data sharing. Through the dedication and hard work of 50 APS ACTION members, collaborative international projects are currently underway including a multicenter web-based registry and repository of aPL-positive patients, a randomized controlled clinical trial assessing the efficacy of hydroxychloroquine for primary thrombosis prevention in persistently aPL-positive but thrombosis-free patients, standardization of aPL testing through the use of core laboratories worldwide, identification of the limitations in the existing aPL/APS literature, and conducting observational research studies to further our understanding of the disease. Thus far, APS ACTION has held annual workshops and summits with the aim of facilitating international collaboration and developing initiatives to recruit young scholars to APS research. This paper describes updates related to the organization's structure, ongoing research efforts, and recent accomplishments and discusses future directions.

  3. A randomized controlled trial of mindfulness to reduce stress and burnout among intern medical practitioners.

    Science.gov (United States)

    Ireland, Michael J; Clough, Bonnie; Gill, Kim; Langan, Fleur; O'Connor, Angela; Spencer, Lyndall

    2017-04-01

    Stress and burnout are highly prevalent among medical doctors, and are associated with negative consequences for doctors, patients, and organizations. The purpose of the current study was to examine the effectiveness of a mindfulness training intervention in reducing stress and burnout among medical practitioners, by means of a Randomised Controlled Trial design. Participants were 44 intern doctors completing an emergency department rotation in a major Australian hospital. Participants were randomly assigned to either an active control (one hour extra break per week) or the 10-week mindfulness training intervention. Measures of stress and burnout were taken pre-, mid- and post intervention. Participants undergoing the 10-week mindfulness training program reported greater improvements in stress and burnout relative to participants in the control condition. Significant reduction in stress and burnout was observed for participants in the mindfulness condition. No such reductions were observed for participants in the control condition. Mindfulness interventions may provide medical practitioners with skills to effectively manage stress and burnout, thereby reducing their experience of these symptoms. It is likely that doctors would benefit from the inclusion of such a training program as a part of their general medical education.

  4. International Clinical Trials in Latin American and Caribbean Countries: Research and Development to Meet Local Health Needs

    Directory of Open Access Journals (Sweden)

    Ricardo E. da Silva

    2018-01-01

    Full Text Available Introduction: Although international health research involves some benefits for the host countries, such as access to innovative treatments, the research itself may not be aligned with their communities' actual health needs.Objective: To map the global landscape of clinical trials run in Latin American and Caribbean countries and discuss the addressing of local health needs in the agenda of international clinical trials.Methods: The present study is a cross-sectional overview and used data referent to studies registered between 01/01/2014 and 12/31/2014 in the World Health Organization's (WHO International Clinical Trials Registry Platform (ICTRP.Results: Non-communicable diseases such as diabetes, cancer, and asthma—studies which were financed mainly by industries—were the conditions investigated most in the region of Latin America and the Caribbean. The neglected diseases, on the other hand, such as Chagas disease, and dengue, made up 1% of the total number of studies. Hospitals and nonprofit nongovernmental organizations prioritize resources for investigating new drugs for neglected diseases, such as Chagas disease and dengue.Conclusion: The international multicenter clinical trials for investigating new drugs are aligned with the health needs of the region of Latin America and the Caribbean, when one considers the burden resulting from the non-communicable diseases in this region. However, the transmissible diseases, such as tuberculosis and AIDS, and the neglected diseases, such as Chagas disease and dengue, which have an important impact on public health in this region, continue to arouse little interest among the institutions which finance the clinical trials.

  5. Methodological recommendations for cognition trials in bipolar disorder by the International Society for Bipolar Disorders Targeting Cognition Task Force

    DEFF Research Database (Denmark)

    Miskowiak, K W; Burdick, K E; Martinez-Aran, A

    2017-01-01

    OBJECTIVES: To aid the development of treatment for cognitive impairment in bipolar disorder, the International Society for Bipolar Disorders (ISBD) convened a task force to create a consensus-based guidance paper for the methodology and design of cognition trials in bipolar disorder. METHODS...... of treatments to illness stage and using a multimodal approach. CONCLUSIONS: This ISBD task force guidance paper provides the first consensus-based recommendations for cognition trials in bipolar disorder. Adherence to these recommendations will likely improve the sensitivity in detecting treatment efficacy...

  6. Immobilization in External Rotation Versus Internal Rotation After Primary Anterior Shoulder Dislocation: A Meta-analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Whelan, Daniel B; Kletke, Stephanie N; Schemitsch, Geoffrey; Chahal, Jaskarndip

    2016-02-01

    The recurrence rate after primary anterior shoulder dislocation is high, especially in young, active individuals. Recent studies have suggested external rotation immobilization as a method to reduce the rate of recurrent shoulder dislocation in comparison to traditional sling immobilization. To assess and summarize evidence from randomized controlled trials on the effect of internal rotation versus external rotation immobilization on the rate of recurrence after primary anterior shoulder dislocation. Meta-analysis. PubMed, MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and abstracts from recent proceedings were searched for eligible studies. Two reviewers selected studies for inclusion, assessed methodological quality, and extracted data. Six randomized controlled trials (632 patients) were included in this review. Demographic and prognostic variables measured at baseline were similar in the pooled groups. The average age was 30.1 years in the pooled external rotation group and 30.3 years in the pooled internal rotation group. Two studies found that external rotation immobilization reduced the rate of recurrence after initial anterior shoulder dislocation compared with conventional internal rotation immobilization, whereas 4 studies failed to find a significant difference between the 2 groups. This meta-analysis suggested no overall significant difference in the rate of recurrence among patients treated with internal rotation versus external rotation immobilization (risk ratio, 0.69; 95% CI, 0.42-1.14; P = .15). There was no significant difference in the rate of compliance between internal and external rotation immobilization (P = .43). The Western Ontario Shoulder Instability Index scores were pooled across 3 studies, and there was no significant difference between the 2 groups (P = .54). Immobilization in external rotation is not significantly more effective in reducing the recurrence rate after primary anterior shoulder dislocation than

  7. The Videofluorographic Swallowing Study in Rheumatologic Diseases: A Comprehensive Review

    Science.gov (United States)

    Di Piazza, Ambra; Costanzo, Massimo; Scopelliti, Laura; Salvaggi, Francesco; Cupido, Francesco; Salerno, Sergio; Lo Casto, Antonio; Midiri, Massimo; Lo Re, Giuseppe; Lagalla, Roberto

    2017-01-01

    Autoimmune connective tissue diseases are a heterogeneous group of pathologies that affect about 10% of world population with chronic evolution in 20%–80%. Inflammation in autoimmune diseases may lead to serious damage to other organs including the gastrointestinal tract. Gastrointestinal tract involvement in these patients may also due to both a direct action of antibodies against organs and pharmacological therapies. Dysphagia is one of the most important symptom, and it is caused by failure of the swallowing function and may lead to aspiration pneumonia, malnutrition, dehydration, weight loss, and airway obstruction. The videofluorographic swallowing study is a key diagnostic tool in the detection of swallowing disorders, allowing to make an early diagnosis and to reduce the risk of gastrointestinal and pulmonary complications. This technique helps to identify both functional and structural anomalies of the anatomic chain involved in swallowing function. The aim of this review is to systematically analyze the basis of the pathological involvement of the swallowing function for each rheumatological disease and to show the main features of the videofluorographic study that may be encountered in these patients. PMID:28706536

  8. Mass spectrometry imaging: a novel technology in rheumatology.

    Science.gov (United States)

    Rocha, Beatriz; Ruiz-Romero, Cristina; Blanco, Francisco J

    2017-01-01

    Mass spectrometry imaging (MSI) is used to determine the relative abundance and spatial distribution of biomolecules such as peptides, proteins, lipids and other organic compounds in tissue sections by their molecular masses. This technique provides a sensitive and label-free approach for high-resolution imaging, and is currently used in an increasing number of biomedical applications such as biomarker discovery, tissue classification and drug monitoring. Owing to technological advances in the past 5 years in diverse MSI strategies, this technology is expected to become a standard tool in clinical practice and provides information complementary to that obtained using existing methods. Given that MSI is able to extract mass-spectral signatures from pathological tissue samples, this technique provides a novel platform to study joint-related tissues affected by rheumatic diseases. In rheumatology, MSI has been performed on articular cartilage, synovium and bone to increase the understanding of articular destruction and to characterize diagnostic and prognostic biomarkers for osteoarthritis, rheumatoid arthritis and osteoporosis. In this Review, we provide an overview of MSI technology and of the studies in which joint tissues have been analysed by use of this methodology. This approach might increase knowledge of rheumatic pathologies and ultimately prompt the development of targeted strategies for their management.

  9. Readability of patient information and consent documents in rheumatological studies.

    Science.gov (United States)

    Hamnes, Bente; van Eijk-Hustings, Yvonne; Primdahl, Jette

    2016-07-16

    Before participation in medical research an informed consent must be obtained. This study investigates whether the readability of patient information and consent documents (PICDs) corresponds to the average educational level of participants in rheumatological studies in the Netherlands, Denmark, and Norway. 24 PICDs from studies were collected and readability was assessed independently using the Gunning's Fog Index (FOG) and Simple Measure of Gobbledygook (SMOG) grading. The mean score for the FOG and SMOG grades were 14.2 (9.0-19.0) and 14.2 (12-17) respectively. The mean FOG and SMOG grades were 12.7 and 13.3 in the Dutch studies, 15.0 and 14.9 in the Danish studies, and 14.6 and 14.3 in the Norwegian studies, respectively. Out of the 2865 participants, more than 57 % had a lower educational level than the highest readability score calculated in the individual study. As the readability level of the PICDs did not match the participants' educational level, consent may not have been valid, as the participants may have had a limited understanding of what they agreed to participate in. There should be more focus on the readability of PICDs. National guidelines for how to write clear and unambiguous PICDs in simple and easily understandable language could increase the focus on the readability of PICD.

  10. Art and rheumatology: the artist and the rheumatologist's perspective.

    Science.gov (United States)

    Hinojosa-Azaola, Andrea; Alcocer-Varela, Jorge

    2014-10-01

    The reflection of medicine in the universal arts has motivated several rheumatologists to discover features of rheumatic diseases depicted by the artist's eyes long before they were defined as specific pathologic entities. The result has been the identification of several pieces of art dating from the Middle Ages, the Renaissance, the Baroque and Post-Impressionist periods that depict clear features of several rheumatic diseases such as RA, OA, camptodactyly and temporal arteritis, among others. On the other hand, great artists such as Pierre-Auguste Renoir, Antoni Gaudí, Raoul Dufy, Paul Klee, Frida Kahlo and Niki de Saint Phalle are good examples of how rheumatic diseases such as RA, scleroderma and chronic pain can influence the artist's perspective, the technique used and the content of their work. Art can serve as a powerful resource to understand the natural course of diseases. By learning through the artist's eyes the way illnesses behave and evolve in time, rheumatologists can trace the history of several conditions. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  11. Integrating rheumatology care in the community: can shared care work?

    Directory of Open Access Journals (Sweden)

    Anita YN Lim

    2015-08-01

    Full Text Available Introduction: Singapore's rapidly ageing population and chronic disease burden at public hospital specialist clinics herald a silver tsunami. In Singapore, “right siting” aims to manage stable chronic disease in primary care at a lower cost. To improve the quality of rheumatology care, we created shared care between rheumatologist and family physician to reduce hospital visits. Methods: Clinical practice improvement methodology was used to structure shared care of stable patients between hospital rheumatologists and eleven community family physicians; one ran a hospital clinic. A case manager coordinated the workflow. Results: About 220 patients entered shared care over 29 months. Patients without hospital subsidies (private patients and private family physicians independently predicted successful shared care, defined as one cycle of alternating care. Discussion: Our shared care model incorporated a case manager, systematic workflows, patient selection criteria, willing family physician partners and rheumatologists in the absence of organizational integration. Health care affordability impacts successful shared care. Government subsidy hindered right siting to private primary care. Conclusions: Financing systems in Singapore, at health policy level, must allow transfer of hospital subsidies to primary care, both private and public, to make it more affordable than hospital care. Structural integration will create a seamless continuum between hospital and primary care.

  12. Integrating rheumatology care in the community: can shared care work?

    Directory of Open Access Journals (Sweden)

    Anita YN Lim

    2015-08-01

    Full Text Available Introduction: Singapore's rapidly ageing population and chronic disease burden at public hospital specialist clinics herald a silver tsunami. In Singapore, “right siting” aims to manage stable chronic disease in primary care at a lower cost. To improve the quality of rheumatology care, we created shared care between rheumatologist and family physician to reduce hospital visits.Methods: Clinical practice improvement methodology was used to structure shared care of stable patients between hospital rheumatologists and eleven community family physicians; one ran a hospital clinic. A case manager coordinated the workflow.Results: About 220 patients entered shared care over 29 months. Patients without hospital subsidies (private patients and private family physicians independently predicted successful shared care, defined as one cycle of alternating care.Discussion: Our shared care model incorporated a case manager, systematic workflows, patient selection criteria, willing family physician partners and rheumatologists in the absence of organizational integration. Health care affordability impacts successful shared care. Government subsidy hindered right siting to private primary care.Conclusions: Financing systems in Singapore, at health policy level, must allow transfer of hospital subsidies to primary care, both private and public, to make it more affordable than hospital care. Structural integration will create a seamless continuum between hospital and primary care.

  13. Flipped Learning: Can Rheumatology Lead the Shift in Medical Education?

    Science.gov (United States)

    El Miedany, Yasser; El Gaafary, Maha; El Aroussy, Nadia; Youssef, Sally

    2018-04-16

    To: 1. implement flipped classroom rheumatology teaching for undergraduate education. 2. Evaluate outcomes of teaching using OSCE assessment and student perceived effectiveness and satisfaction survey. The flipped classroom education was conducted in 3 phases. Phase 1: carried out in the students' own time. Web links were emailed to assist exposure of the instructional part of the lesson online. Phase 2: interactive in-class activity to share personal reflection and reinforce the key aspects. Phase 3: a simulated OSCE assessment. A cohort of 56-students, who were taught in the last educational year on the same topics according to standard teaching protocols, were included as control group. The clinical Outcomes were assessed using the scores of the OSCE examination model. Academic outcomes included the engagement measure as well as the students' answers to perceived effectiveness and satisfaction survey. There was no significant difference regarding demographics between the 2 students' groups. There was significant improvement (plearning, in contrast to the control group, in terms of clinical (OSCE score) as well as communication skills. Student perceived effectiveness and satisfaction was significantly higher among the flipped learning (plearning cohort showed a state of engagement significantly higher than the control group (plearning implementation musculoskeletal learning successfully demonstrated a promising platform for using technology to make better use of the students' time, and for increasing their satisfaction. Active learning increases student engagement and can lead to improved retention of knowledge. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  14. Integrating rheumatology care in the community: can shared care work?

    Science.gov (United States)

    Lim, Anita Yn; Tan, Chuen Seng; Low, Bernadette Pl; Lau, Tang Ching; Tan, Tze Lee; Goh, Lee Gan; Teng, Gim Gee

    2015-01-01

    Singapore's rapidly ageing population and chronic disease burden at public hospital specialist clinics herald a silver tsunami. In Singapore, "right siting" aims to manage stable chronic disease in primary care at a lower cost. To improve the quality of rheumatology care, we created shared care between rheumatologist and family physician to reduce hospital visits. Clinical practice improvement methodology was used to structure shared care of stable patients between hospital rheumatologists and eleven community family physicians; one ran a hospital clinic. A case manager coordinated the workflow. About 220 patients entered shared care over 29 months. Patients without hospital subsidies (private patients) and private family physicians independently predicted successful shared care, defined as one cycle of alternating care. Our shared care model incorporated a case manager, systematic workflows, patient selection criteria, willing family physician partners and rheumatologists in the absence of organizational integration. Health care affordability impacts successful shared care. Government subsidy hindered right siting to private primary care. Financing systems in Singapore, at health policy level, must allow transfer of hospital subsidies to primary care, both private and public, to make it more affordable than hospital care. Structural integration will create a seamless continuum between hospital and primary care.

  15. Italian Society of Rheumatology (SIR recommendations for performing arthrocentesis

    Directory of Open Access Journals (Sweden)

    A. Spadaro

    2011-09-01

    Full Text Available Joint fluid aspiration, or arthrocentesis, is one of the most useful and commonly performed procedures for the diagnosis and treatment of rheumatic diseases, but to date no definite guidelines have been published. For this reason, a group of experts of the Italian Society of Rheumatology (SIR produced evidence based recommendations for performing arthrocentesis. Among them, the most relevant are: a arthrocentesis is necessary when synovial effusion of unknown origin is present, especially if septic or crystal arthritis is suspected; b the patient should be clearly informed of the benefits and risks of the procedure in order to give an informed consent; c ultrasonography should be used to facilitate arthrocentesis in difficult joints; d fluid evacuation often has a therapeutic effect and facilitates the success of the following intraarticular injection; e careful skin disinfection and the use of sterile, disposable material is mandatory for avoiding septic complications. Disposable, non sterile gloves should always be used by the operator, mainly for his own protection; f contraindications are the presence of skin lesions or infections in the area of the puncture; g the patient’s anticoagulant treatment is not a contraindication, providing the therapeutic range is not exceeded; h joint rest after arthrocentesis is not indicated. Several of these recommendations were based on experts’ opinion rather than on published evidence which is scanty.

  16. [Amendment of the structural quality for inpatient rheumatology. A forward-looking concept].

    Science.gov (United States)

    Lakomek, H-J; Braun, J; Gromnica-Ihle, E; Fiehn, C; Claus, S; Specker, C; Jung, J; Krause, A; Lorenz, H-M; Robbers, J

    2011-09-01

    In 2010 a total of 9 guidelines on structural quality were endorsed by the Association of Rheumatology Clinics in Germany (VRA). These 9 structural criteria replace the regulations published in 2002 and were elaborated with the support of the German Rheumatology League. With guideline number 9 even the structural requirements for university hospitals are defined for the first time.Along with taking part in the quality project "Kobra" (continuous outcome benchmarking in rheumatology inpatient treatment) compliance with the new structural criteria constitutes a prerequisite for acquiring a quality certificate, which is awarded by an external institution.By this means the VRA sets the stage for its members to be prepared for future challenges and quality competition among hospitals. Furthermore, the provision of a high quality treatment for chronically diseased patients in rheumatology clinics will be effectively supported.

  17. Predictors of bacterial pneumonia in Evaluation of Subcutaneous Interleukin-2 in a Randomized International Trial (ESPRIT).

    Science.gov (United States)

    Pett, S L; Carey, C; Lin, E; Wentworth, D; Lazovski, J; Miró, J M; Gordin, F; Angus, B; Rodriguez-Barradas, M; Rubio, R; Tambussi, G; Cooper, D A; Emery, S

    2011-04-01

    Bacterial pneumonia still contributes to morbidity/mortality in HIV infection despite effective combination antiretroviral therapy (cART). Evaluation of Subcutaneous Interleukin-2 in a Randomized International Trial (ESPRIT), a trial of intermittent recombinant interleukin-2 (rIL-2) with cART vs. cART alone (control arm) in HIV-infected adults with CD4 counts ≥300cells/μL, offered the opportunity to explore associations between bacterial pneumonia and rIL-2, a cytokine that increases the risk of some bacterial infections. Baseline and time-updated factors associated with first-episode pneumonia on study were analysed using multivariate proportional hazards regression models. Information on smoking/pneumococcal vaccination history was not collected. IL-2 cycling was most intense in years 1-2. Over ≈7 years, 93 IL-2 [rate 0.67/100 person-years (PY)] and 86 control (rate 0.63/100 PY) patients experienced a pneumonia event [hazard ratio (HR) 1.06; 95% confidence interval (CI) 0.79, 1.42; P=0.68]. Median CD4 counts prior to pneumonia were 570cells/μL (IL-2 arm) and 463cells/μL (control arm). Baseline risks for bacterial pneumonia included older age, injecting drug use, detectable HIV viral load (VL) and previous recurrent pneumonia; Asian ethnicity was associated with decreased risk. Higher proximal VL (HR for 1 log(10) higher VL 1.28; 95% CI 1.11, 1.47; P<0.001) was associated with increased risk; higher CD4 count prior to the event (HR per 100 cells/μL higher 0.94; 95% CI 0.89, 1.0; P=0.04) decreased risk. Compared with controls, the hazard for a pneumonia event was higher if rIL-2 was received <180 days previously (HR 1.66; 95% CI 1.07, 2.60; P=0.02) vs.≥180 days previously (HR 0.98; 95% CI 0.70, 1.37; P=0.9). Compared with the control group, pneumonia risk in the IL-2 arm decreased over time, with HRs of 1.41, 1.71, 1.16, 0.62 and 0.84 in years 1, 2, 3-4, 5-6 and 7, respectively. Bacterial pneumonia rates in cART-treated adults with moderate

  18. Current provision of rheumatology education for undergraduate nursing, occupational therapy and physiotherapy students in the UK.

    Science.gov (United States)

    Almeida, C; Clarke, B; O'Brien, A; Hammond, A; Ryan, S; Kay, L; Hewlett, S

    2006-07-01

    Rheumatological conditions are common and all health professionals (HPs) therefore need sufficient knowledge and skills to manage patients safely and effectively. The aim of this study was to examine current undergraduate education in rheumatology for HPs in the UK. A questionnaire was sent to curriculum organizers and clinical placement officers for all undergraduate courses in adult nursing, occupational therapy (OT) and physiotherapy (PT) in the UK to ascertain the nature and amount of rheumatology theory and clinical exposure provided. Of the 47 adult nursing, 26 OT and 30 PT undergraduate courses surveyed, 85-90% responded. Overall, rheumatology teaching is 5-10 h over 3 yr. Nursing students receive moderate/in-depth teaching on rheumatoid arthritis (RA) in only 52% of courses (OT 91%, PT 96%) and on osteoarthritis (OA) in 63% (OT 91%, PT 92%). Clinical experience of RA is probably/definitely available in only 56% of nursing courses (OT 72%, PT 88%), with similar results in OA. Overall, nursing students receive the least rheumatology exposure, particularly in psychosocial issues and symptom management, while PT students receive the most. OT students have limited opportunities for clinical exposure to psychosocial and joint protection issues. Use of local rheumatology clinical HP experts is variable (18-93%) and cross-disciplinary exposure is limited (0-36%). Many educators consider their rheumatology training to be insufficient (nursing 50%, PT 42%, OT 24%). Rheumatology training for undergraduate HPs is limited in key areas and often fails to take advantage of local clinical expertise, with nursing students particularly restricted. Clinical HP experts should consider novel methods of addressing these shortfalls within the limited curriculum time available.

  19. Involving patient research partners has a significant impact on outcomes research: a responsive evaluation of the international OMERACT conferences.

    NARCIS (Netherlands)

    de Wit, M.P.T.; Abma, T.A.; Koelewijn-van Loon, M.S.; Collins, S.; Kirwan, J

    2013-01-01

    Objective: To assess the inclusion of patients as international research partners in Outcome Measures in Rheumatology (OMERACT) conferences and how this has influenced the scope and conduct of outcomes research in rheumatology. Design: A thematic content analysis of OMERACT internal documents,

  20. The evaluation of subcutaneous proleukin (interleukin-2) in a randomized international trial: rationale, design, and methods of ESPRIT.

    Science.gov (United States)

    Emery, Sean; Abrams, Donald I; Cooper, David A; Darbyshire, Janet H; Lane, H Clifford; Lundgren, Jens D; Neaton, James D

    2002-04-01

    The Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) is a large ongoing randomized trial of subcutaneous interleukin-2 (IL-2) plus antiretroviral therapy versus antiretroviral therapy alone in patients with HIV (human immunodeficiency virus) disease and CD4 cell counts of at least 300 cells/mm(3). The primary objective is to determine whether the addition of IL-2 to combination antiretroviral therapy improves morbidity and mortality. The aim is to recruit 4000 participants and follow them for an average of 5 years. Eligible subjects will be recruited at 275 investigational sites in 23 countries around the world. Coupled with broad eligibility criteria this will ensure widely applicable results. A range of secondary objectives will also be addressed in this setting that will include the conduct of observational studies and nested substudies with a public health focus. This article describes the rationale supporting the trial in addition to reviewing the study design, coordination, and governance.

  1. Methodological recommendations for cognition trials in bipolar disorder by the International Society for Bipolar Disorders Targeting Cognition Task Force

    DEFF Research Database (Denmark)

    Miskowiak, K W; Burdick, K E; Martinez-Aran, A

    2017-01-01

    OBJECTIVES: To aid the development of treatment for cognitive impairment in bipolar disorder, the International Society for Bipolar Disorders (ISBD) convened a task force to create a consensus-based guidance paper for the methodology and design of cognition trials in bipolar disorder. METHODS...... symptoms and concomitant medication. Task force recommendations are to: (i) enrich trials with objectively measured cognitively impaired patients; (ii) generally select a broad cognitive composite score as the primary outcome and a functional measure as a key secondary outcome; and (iii) include remitted...... of treatments to illness stage and using a multimodal approach. CONCLUSIONS: This ISBD task force guidance paper provides the first consensus-based recommendations for cognition trials in bipolar disorder. Adherence to these recommendations will likely improve the sensitivity in detecting treatment efficacy...

  2. Immunology for rheumatology residents: working toward a Canadian national curriculum consensus.

    Science.gov (United States)

    Chow, Shirley L; Herman-Kideckel, Sari; Mahendira, Dharini; McDonald-Blumer, Heather

    2015-01-01

    Immunologic mechanisms play an integral role in understanding the pathogenesis and management of rheumatic conditions. Currently, there is limited access to formal instruction in immunology for rheumatology trainees across Canada. The aims of this study were (1) to describe current immunology curricula among adult rheumatology training programs across Canada and (2) to compare the perceived learning needs of rheumatology trainees from the perspective of program directors and trainees to help develop a focused nationwide immunology curriculum. Rheumatology trainees and program directors from adult rheumatology programs across Canada completed an online questionnaire and were asked to rank a comprehensive list of immunology topics. A modified Delphi approach was implemented to obtain consensus on immunology topics. Only 42% of program directors and 31% of trainees felt the current method of teaching immunology was effective. Results illustrate concordance between program directors and trainees for the highest-ranked immunology topics including innate immunity, adaptive immunity, and cells and tissues of the immune system. However, there was discordance among other topics, such as diagnostic laboratory immunology and therapeutics. There is a need to improve immunology teaching in rheumatology training programs. Results show high concordance between the basic immunology topics. This study provides the groundwork for development of future immunology curricula.

  3. Mental health care for youth with rheumatologic diseases - bridging the gap.

    Science.gov (United States)

    Davis, Alaina M; Rubinstein, Tamar B; Rodriguez, Martha; Knight, Andrea M

    2017-12-28

    Youth with rheumatologic diseases have a high prevalence of comorbid mental health disorders. Individuals with comorbid mental health disorders are at increased risk for adverse outcomes related to mental health as well as their underlying rheumatologic disease. Early identification and treatment of mental health disorders has been shown to improve outcomes, but current systems of care fall short in providing adequate mental health services to those in need. Pediatric rheumatologists are uniquely positioned to provide mental health screening and intervention for youth with rheumatologic diseases due to the frequency of patient encounters and ongoing therapeutic relationship with patients and families. However, additional training is likely required for pediatric rheumatologists to provide effective mental health care, and focusing efforts on providing trainees with mental health education is key to building competency. Potential opportunities for improved mental health education include development of clinical guidelines regarding mental health screening and management within pediatric rheumatology settings and incorporation of mental health didactics, workshops, and interdisciplinary clinic experiences into pediatric rheumatology fellowship curricula. Additional steps include mental health education for patients and families and focus on system change, targeting integration of medical and mental health care. Research is needed to better define the scope of the problem, determine effective strategies for equipping pediatric rheumatologists with skills in mental health intervention, and develop and implement sustainable systems for delivery of optimal mental health care to youth with rheumatologic diseases.

  4. Quality of life in rheumatological patients: The impact of personality disorders.

    Science.gov (United States)

    Uguz, Faruk; Kucuk, Adem; Cicek, Erdinc; Kayhan, Fatih; Salli, Ali; Guncu, Hatice; Çilli, Ali Savas

    2015-01-01

    Rheumatological diseases are associated with lower quality of life (QoL) levels. Psychiatric disturbances are frequently observed in these patients. This study examined the impact of personality disorders on the QoL of patients with rheumatological diseases. The study sample consisted of 142 participants including patients suffering from rheumatological disease with a personality disorder (n = 30), without any personality disorder (n = 112), and healthy control participants without physical or psychiatric disorders (n = 60). The Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID-I) and the Structured Clinical Interview for DSM, Revised Third Edition Personality Disorders (SCID-II) were used to determine Axis I and Axis II psychiatric disorders, respectively. QoL levels were assessed by means of the World Health Organization QoL Assessment-Brief. The subscale scores of physical health, psychological health, and social relationships were significantly lower in patients with rheumatological disease regardless of the existence of personality disorder compared with the control participants. Rheumatological patients with a personality disorder had significantly lower subscale scores of psychological health (p = 0.003) and social relationships (p personality disorder. Personality disorders seem to be a relevant factor that maybe associated with QoL in patients suffering from rheumatological disease. © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  5. Current educational status of paediatric rheumatology in Europe: the results of PReS survey.

    Science.gov (United States)

    Demirkaya, E; Ozen, S; Türker, T; Kuis, W; Saurenmann, R K

    2009-01-01

    To understand the status of education and problems in paediatric rheumatology practice in Europe, through a survey. A 26-item questionnaire was conducted during the 14th Congress of the Paediatric Rheumatology European Society in Istanbul, 2007. Physicians who were practicing or studying within the field of paediatric rheumatology for at least one year were included in the survey. One hundred and twenty eight physicians, 79 paediatric rheumatologists (including 5 paediatric immunologists and 10 paediatric nephrologists), 34 paediatric rheumatology fellows and 15 adult rheumatologists completed the survey. The physicians were from: Europe 95 (81.9%), South America 12 (10.4%), Middle East 5 (4.3%), Asia 2 (1.7%), Africa 2 (1.7%). The duration of training for paediatric rheumatology ranged between 1-5 years (mean: 3.12+/-1.11). Sixty physicians scored their education as unsatisfactory and among those, 48 physicians were from Europe. Physicians reported good skills in the following items; intraarticular injections (83.3%); soft tissue injections (47.6%); evaluation of radiographs (67.5%); whereas competence in the evaluation of computed tomography/magnetic resonance imaging (30.5%); and musculoskeletal sonography (16.7%) was much lower. A need for improved basic science and rotations among relevant fields were specifically expressed. Being a relatively new speciality in the realm of paediatrics, paediatric rheumatology education at the European level needs to be further discussed, revised and uniformed.

  6. Collaborative translational research leading to multicenter clinical trials in Duchenne muscular dystrophy: the Cooperative International Neuromuscular Research Group (CINRG).

    Science.gov (United States)

    Escolar, Diana M; Henricson, Erik K; Pasquali, Livia; Gorni, Ksenija; Hoffman, Eric P

    2002-10-01

    Progress in the development of rationally based therapies for Duchenne muscular dystrophy has been accelerated by encouraging multidisciplinary, multi-institutional collaboration between basic science and clinical investigators in the Cooperative International Research Group. We combined existing research efforts in pathophysiology by a gene expression profiling laboratory with the efforts of animal facilities capable of conducting high-throughput drug screening and toxicity testing to identify safe and effective drug compounds that target different parts of the pathophysiologic cascade in a genome-wide drug discovery approach. Simultaneously, we developed a clinical trial coordinating center and an international network of collaborating physicians and clinics where those drugs could be tested in large-scale clinical trials. We hope that by bringing together investigators at these facilities and providing the infrastructure to support their research, we can rapidly move new bench discoveries through animal model screening and into therapeutic testing in humans in a safe, timely and cost-effective setting.

  7. Findings of the International Subarachnoid Aneurysm Trial and the National Study of Subarachnoid Haemorrhage in context.

    Science.gov (United States)

    Reeves, B C; Langham, J; Lindsay, K W; Molyneux, A J; Browne, J P; Copley, L; Shaw, D; Gholkar, A; Kirkpatrick, P J

    2007-08-01

    Concern has been expressed about the applicability of the findings of the International Subarachnoid Aneurysm Trial (ISAT) with respect to the relative effects on outcome of coiling and clipping. It has been suggested that the findings of the National Study of Subarachnoid Haemorrhage may have greater relevance for neurosurgical practice. The objective of this paper was to interpret the findings of these two studies in the context of differences in their study populations, design, execution and analysis. Because of differences in design and analysis, the findings of the two studies are not directly comparable. The ISAT analysed all randomized patients by intention-to-treat, including some who did not undergo a repair, and obtained the primary outcome for 99% of participants. The National Study only analysed participants who underwent clipping or coiling, according to the method of repair, and obtained the primary outcome for 91% of participants. Time to repair was also considered differently in the two studies. The comparison between coiling and clipping was susceptible to confounding in the National Study, but not in the ISAT. The two study populations differed to some extent, but inspection of these differences does not support the view that coiling was applied inappropriately in the National Study. Therefore, there are many reasons why the two studies estimated different sizes of effect. The possibility that there were real, systematic differences in practice between the ISAT and the National Study cannot be ruled out, but such explanations must be seen in the context of other explanations relating to chance, differences in design or analysis, or confounding.

  8. Long-term Bias of Internal Markers in Sheep and Goat Digestion Trials

    Directory of Open Access Journals (Sweden)

    Gleidson Giordano Pinto de Carvalho

    2013-01-01

    Full Text Available Two digestion trials, one with sheep and another with goats, were conducted to evaluate the long-term bias (LTB of the indigestible dry matter (iDM, indigestible neutral detergent fiber (iNDF and indigestible acid detergent fiber (iADF internal markers. The study used eight Santa Inês castrated male sheep (average body weight of 16.6 kg distributed in two 4×4 Latin squares and eight Saanen castrated male goats (average body weight of 22.6 kg distributed in two 4×4 Latin squares. The experiments were conducted simultaneously, and the animals were housed in 1.2 m2 individual pens with wood-battened floors equipped with individual feeders and drinkers. The animals received isonitrogenous diets that were offered ad libitum and contained 14% crude protein and 70% sugar cane (with 0, 0.75, 1.5 or 2.25% CaO, in natural matter percentage, corrected with 1% urea and 30% concentrate. The experiment consisted of four experimental periods of 14 d each, with the feed, leftovers and feces sampled on the last four days of each period. The marker concentrations in the feed, leftovers and fecal samples were estimated by an in situ ruminal incubation procedure with a duration 240 h. The relationship between the intake and excretion of the markers was obtained by adjusting a simple linear regression model, independently from the treatment (diets fixed effects and Latin squares. For both the sheep and goats, a complete recovery of the iDM and iNDF markers was observed (p>0.05, indicating the absence of LTB for these markers. However, the iADF was not completely recovered, exhibiting an LTB of −9.12% (p<0.05 in the sheep evaluation and −3.02% (p<0.05 in the goat evaluation.

  9. An international, multicenter phase II trial of bortezomib in patients with hepatocellular carcinoma

    Science.gov (United States)

    Kim, George P.; Mahoney, Michelle R.; Szydlo, Daniel; Mok, Tony S. K.; Marshke, Robert; Holen, Kyle; Picus, Joel; Boyer, Michael; Pitot, Henry C.; Rubin, Joseph; Philip, Philip A.; Nowak, Anna; Wright, John J.; Erlichman, Charles

    2013-01-01

    Summary Background and Rationale Bortezomib (PS-341, VELCADE®) is a selective inhibitor of the 26S proteasome, an integral component of the ubiquitinproteasome pathway. This phase II study evaluated the activity and tolerability of bortezomib in unresectable hepatocellular carcinoma (HCC) patients. Methods The primary endpoint was confirmed tumor response rate (RR) with secondary endpoints including duration of response, time to disease progression, survival and toxicity. Treatment consisted of bortezomib, 1.3 mg/m2 IV bolus on days 1, 4, 8, and 11 of each 21-day treatment cycle. Eligibility included: no prior systemic chemotherapy, ECOG PS 0-2, Child-Pugh A or B, preserved hematologic, hepatic and neurologic function; prior liver-directed therapy was permitted. Results Thirty-five patients enrolled and received a median of 2 cycles of treatment (range 1–12). Overall, 24 and 4 patients had a maximum severity of grade 3 and 4 adverse events (AEs), respectively. No treatment related deaths occurred. Only thrombocytopenia (11%) was seen in greater than 10% of patients. One patient achieved a partial response, lasting 13 weeks during treatment and progressed 11.6 months later; two patients received treatment for greater than 6 months. Median time-to-progression was 1.6 months and median survival was 6.0 months. Conclusions This international, multicenter trial evaluated bortezomib as monotherapy in unresectable HCC patients. And, despite the lack of significant activity, this report serves as a baseline clinical experience for the development of future dual biologic approaches including bortezomib. PMID:20839030

  10. Quality of randomized controlled trials published in the International Urogynecology Journal 2007-2016.

    Science.gov (United States)

    Kim, Kyu Shik; Chung, Jae Hoon; Jo, Jung Ki; Kim, Jae Heon; Kim, Seungjun; Cho, Jeoung Man; Cho, Hee Ju; Choi, Hong Yong; Lee, Seung Wook

    2018-07-01

    Randomized controlled trials (RCTs) provide the best quality clinical evidence. The aim of this study was to assess the quality of RCTs published by the International Urogynecology Journal (IUJ) in 2007-2016. RCTs in original articles were extracted from PubMed and IUJ homepage. Change in RCT quality over time was assessed with Jadad and van Tulder scales and Cochrane Collaboration's risk of bias tool (CCRBT). Jadad scores of 3-5 or van Tulder scores of >5 indicated high-quality RCTs. The effect on RCT quality of including funding source and institutional review board (IRB) approval statements and describing the intervention was assessed. In addition, changes in RCT topics over time were assessed. Annual RCT frequencies did not change significantly (6.7-15.7%): 36.1% and 25.7% described blinding and allocation concealment, respectively. Both tended to increase between 2013 and 2016, particularly 2013 and 2014. Funding statement inclusion (39.1% overall) and intervention description (78.2% overall) tended to increase steadily. IRB statement inclusion (60.4% overall) increased significantly (p < 0.01). Jadad scores and van Tulder rose significantly until 2014 (p < 0.01). Frequencies of high-quality RCTs tended to rise. CCRBT indicated that RCTs with a low risk of bias tended to increase until 2014. However, from 2015, Jadad scores, van Tulder, and CCRBT the low risk tended to decreased. RCTs with funding and IRB approval statements had higher Jadad and van Tulder scores than unfunded RCTs (p < 0.01 and p < 0.01, respectively). Intervention description did not associate with better quality. RCT quality improved over time, but a dip in quality was observed in 2015-2016 because of decreased blinding and allocation concealment.

  11. The role of internal limiting membrane peeling in epiretinal membrane surgery: a randomised controlled trial.

    Science.gov (United States)

    Tranos, Paris; Koukoula, Stavrenia; Charteris, Davic G; Perganda, Georgia; Vakalis, Athanasios; Asteriadis, Solon; Georgalas, Ilias; Petrou, Petros

    2017-06-01

    To compare the anatomical and functional outcomes after primary idiopathic epiretinal membrane (ERM) peeling with or without internal limiting membrane (ILM) peeling. A two-centre randomised, controlled clinical trial with 12 months of follow-up. One hundred and two eyes of 102 patients were included in the analysis and were randomised into two groups (ILM peeling (P) and non-ILM peeling (NP) group). Inclusion criteria were: Idiopathic ERM confirmed on optical coherence tomography, age ≥18 years, binocular distortion, best-corrected visual acuity (BCVA) ≤90 ETDRS letters, intraocular pressure ≤23 mm Hg and informed consent. The primary outcome measure was the mean change in the ETDRS distance BCVA at 12 months' follow-up for each group. The mean change in distance BCVA at 12 months was 0.30±0.24 logMAR (15 ETDRS letters) in the P group and 0.31±0.23 logMAR (14 ETDRS letters) in the NP group, a change that was not statistically significant (p=0.84). No statistically significant differences were observed when comparing the changes in distance BCVA, the changes in metamorphopsia (Amsler grid) and the changes in central retinal thickness between the two groups at any of the time points studied. Our analysis suggests that ILM peeling in idiopathic ERM surgery does not result in better visual improvement. The more frequent presence of an uninterrupted interdigitation zone in the P group did not result in a better functional outcome of our patients. No recurrent ERMs were noted in either group. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  12. The costs associated with adverse event procedures for an international HIV clinical trial determined by activity-based costing.

    Science.gov (United States)

    Chou, Victoria B; Omer, Saad B; Hussain, Hamidah; Mugasha, Christine; Musisi, Maria; Mmiro, Francis; Musoke, Philippa; Jackson, J Brooks; Guay, Laura A

    2007-12-01

    To determine costs for adverse event (AE) procedures for a large HIV perinatal trial by analyzing actual resource consumption using activity-based costing (ABC) in an international research setting. The AE system for an ongoing clinical trial in Uganda was evaluated using ABC techniques to determine costs from the perspective of the study. Resources were organized into cost categories (eg, personnel, patient care expenses, laboratory testing, equipment). Cost drivers were quantified, and unit cost per AE was calculated. A subset of time and motion studies was performed prospectively to observe clinic personnel time required for AE identification. In 18 months, there were 9028 AEs, with 970 (11%) reported as serious adverse events. Unit cost per AE was $101.97. Overall, AE-related costs represented 32% ($920,581 of $2,834,692) of all study expenses. Personnel ($79.30) and patient care ($11.96) contributed the greatest proportion of component costs. Reported AEs were predominantly nonserious (mild or moderate severity) and unrelated to study drug(s) delivery. Intensive identification and management of AEs to conduct clinical trials ethically and protect human subjects require expenditure of substantial human and financial resources. Better understanding of these resource requirements should improve planning and funding of international HIV-related clinical trials.

  13. Adjuvant chemotherapy with sequential or concurrent anthracycline and docetaxel: Breast International Group 02-98 randomized trial

    DEFF Research Database (Denmark)

    Francis, P.; Crown, J.; Di, Leo A.

    2008-01-01

    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....... However, important differences may be related to doxorubicin and docetaxel scheduling, with sequential but not concurrent administration, appearing to produce better DFS than anthracycline-based chemotherapy Udgivelsesdato: 2008/1/16...

  14. The relationship between external and internal validity of randomized controlled trials: A sample of hypertension trials from China

    Directory of Open Access Journals (Sweden)

    Xin Zhang

    2015-10-01

    Conclusion: Several components relate to the external validity of RCTs do associate with the internal validity, that do not stand in an easy relationship to each other. Regarding the poor reporting, other possible links between two variables need to trace in the future methodological researches.

  15. Sodium oxybate therapy provides multidimensional improvement in fibromyalgia: results of an international phase 3 trial

    Science.gov (United States)

    Spaeth, Michael; Bennett, Robert M; Benson, Beverly A; Wang, Y Grace; Lai, Chinglin; Choy, Ernest H

    2012-01-01

    Background Fibromyalgia is characterised by chronic musculoskeletal pain and multiple symptoms including fatigue, multidimensional function impairment, sleep disturbance and tenderness. Along with pain and fatigue, non-restorative sleep is a core symptom of fibromyalgia. Sodium oxybate (SXB) is thought to reduce non-restorative sleep abnormalities. This study evaluated effects of SXB on fibromyalgia-related pain and other symptoms. Methods 573 patients with fibromyalgia according to 1990 American College of Rheumatology criteria were enrolled at 108 centres in eight countries. Subjects were randomly assigned to placebo, SXB 4.5 g/night or SXB 6 g/night. The primary efficacy endpoint was the proportion of subjects with ≥30% reduction in pain visual analogue scale from baseline to treatment end. Other efficacy assessments included function, sleep quality, effect of sleep on function, fatigue, tenderness, health-related quality of life and subject's impression of change in overall wellbeing. Results Significant improvements in pain, sleep and other symptoms associated with fibromyalgia were seen in SXB treated subjects compared with placebo. The proportion of subjects with ≥30% pain reduction was 42.0% for SXB4.5 g/night (p=0.002) and 51.4% for SXB6 g/night (pQuality of sleep (Jenkins sleep scale) improved by 20% for SXB4.5 g/night (p≤0.001) and 25% for SXB6 g/night (p≤0.001) versus 0.5% for placebo. Adverse events with an incidence ≥5% and twice placebo were nausea, dizziness, vomiting, insomnia, anxiety, somnolence, fatigue, muscle spasms and peripheral oedema. Conclusion These results, combined with findings from previous phase 2 and 3 studies, provide supportive evidence that SXB therapy affordsimportant benefits across multiple symptoms in subjects with fibromyalgia. PMID:22294641

  16. The DAMASK trial protocol: a pragmatic randomised trial to evaluate whether GPs should have direct access to MRI for patients with suspected internal derangement of the knee

    Directory of Open Access Journals (Sweden)

    Orchard Jo

    2006-10-01

    Full Text Available Abstract Background Though new technologies like Magnetic Resonance Imaging (MRI may be accurate, they often diffuse into practice before thorough assessment of their value in diagnosis and management, and of their effects on patient outcome and costs. MRI of the knee is a common investigation despite concern that it is not always appropriate. There is wide variation in general practitioners (GPs access to, and use of MRI, and in the associated costs. The objective of this study was to resolve uncertainty whether GPs should refer patients with suspected internal derangement of the knee for MRI or to an orthopaedic specialist in secondary care. Methods/Design The design consisted of a pragmatic multi-centre randomised trial with two parallel groups and concomitant economic evaluation. Patients presenting in general practice with suspected internal derangement of the knee and for whom their GP was considering referral to an orthopaedic specialist in secondary care were eligible for inclusion. Within practices, GPs or practice nurses randomised eligible and consenting participants to the local radiology department for an MRI examination, or for consultation with an orthopaedic specialist. To ensure that the waiting time from GP consultation to orthopaedic appointment was similar for both trial arms, GPs made a provisional referral to orthopaedics when requesting the MRI examination. Thus we evaluated the more appropriate sequence of events independent of variations in waiting times. Follow up of participants was by postal questionnaires at six, twelve and 24 months after randomisation. This was to ensure that the evaluation covered all events up to and including arthroscopy. Discussion The DAMASK trial should make a major contribution to the development of evidence-based partnerships between primary and secondary care professionals and inform the debate when MRI should enter the diagnostic pathway.

  17. The DAMASK trial protocol: a pragmatic randomised trial to evaluate whether GPs should have direct access to MRI for patients with suspected internal derangement of the knee

    Science.gov (United States)

    Brealey, Stephen D; Atwell, Christine; Bryan, Stirling; Coulton, Simon; Cox, Helen; Cross, Ben; Fylan, Fiona; Garratt, Andrew; Gilbert, Fiona J; Gillan, Maureen GC; Hendry, Maggie; Hood, Kerenza; Houston, Helen; King, David; Morton, Veronica; Orchard, Jo; Robling, Michael; Russell, Ian T; Torgerson, David; Wadsworth, Valerie; Wilkinson, Clare

    2006-01-01

    Background Though new technologies like Magnetic Resonance Imaging (MRI) may be accurate, they often diffuse into practice before thorough assessment of their value in diagnosis and management, and of their effects on patient outcome and costs. MRI of the knee is a common investigation despite concern that it is not always appropriate. There is wide variation in general practitioners (GPs) access to, and use of MRI, and in the associated costs. The objective of this study was to resolve uncertainty whether GPs should refer patients with suspected internal derangement of the knee for MRI or to an orthopaedic specialist in secondary care. Methods/Design The design consisted of a pragmatic multi-centre randomised trial with two parallel groups and concomitant economic evaluation. Patients presenting in general practice with suspected internal derangement of the knee and for whom their GP was considering referral to an orthopaedic specialist in secondary care were eligible for inclusion. Within practices, GPs or practice nurses randomised eligible and consenting participants to the local radiology department for an MRI examination, or for consultation with an orthopaedic specialist. To ensure that the waiting time from GP consultation to orthopaedic appointment was similar for both trial arms, GPs made a provisional referral to orthopaedics when requesting the MRI examination. Thus we evaluated the more appropriate sequence of events independent of variations in waiting times. Follow up of participants was by postal questionnaires at six, twelve and 24 months after randomisation. This was to ensure that the evaluation covered all events up to and including arthroscopy. Discussion The DAMASK trial should make a major contribution to the development of evidence-based partnerships between primary and secondary care professionals and inform the debate when MRI should enter the diagnostic pathway. PMID:17040558

  18. [The National Database of the Regional Collaborative Rheumatic Centers as a tool for clinical epidemiology and quality assessment in rheumatology].

    Science.gov (United States)

    Zink, Angela; Huscher, Dörte; Listing, Joachim

    2003-01-01

    The national database of the German Collaborative Arthritis Centres is a well-established tool for the observation and assessment of health care delivery to patients with rheumatic diseases in Germany. The discussion of variations in treatment practices contributes to the internal quality assessment in the participating arthritis centres. This documentation has shown deficits in primary health care including late referral to a rheumatologist, undertreatment with disease-modifying drugs and complementary therapies. In rheumatology, there is a trend towards early, intensive medical treatment including combination therapy. The frequency and length of inpatient hospital and rehabilitation treatments is decreasing, while active physiotherapy in outpatient care has been increased. Specific deficits have been identified concerning the provision of occupational therapy services and patient education.

  19. In Absentia War Crimes Trials: A Just Means to Enforce International Human Rights?

    National Research Council Canada - National Science Library

    Prescott, Jody M

    1994-01-01

    .... This thesis argues that a modified civil-law style default trial procedure, in which the absent accused is represented by appointed counsel at a complete hearing, but still has the right to a new...

  20. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.

    NARCIS (Netherlands)

    Ederle, J.; Dobson, J.; Featherstone, R.L.; Bonati, L.H.; Worp, H.B. van der; Borst, G.J. de; Lo, T.H.; Gaines, P.; Dorman, P.J.; Macdonald, S.; Lyrer, P.A.; Hendriks, J.M.; McCollum, C.; Nederkoorn, P.J.; Brown, M.M.; Blankensteijn, J.D.; Leeuw, F.E. de; Schultze Kool, L.J.; Vliet, J.A. van der; et al.,

    2010-01-01

    BACKGROUND: Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. METHODS: The International

  1. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial

    NARCIS (Netherlands)

    Ederle, Jörg; Dobson, Joanna; Featherstone, Roland L.; Bonati, Leo H.; van der Worp, H. Bart; de Borst, Gert J.; Lo, T. Hauw; Gaines, Peter; Dorman, Paul J.; Macdonald, Sumaira; Lyrer, Philippe A.; Hendriks, Johanna M.; McCollum, Charles; Nederkoorn, Paul J.; Brown, Martin M.; Algra, A.; Bamford, J.; Beard, J.; Bland, M.; Bradbury, A. W.; Brown, M. M.; Clifton, A.; Gaines, P.; Collins, R.; Molyneux, A.; Naylor, R.; Warlow, C.; Ferro, J. M.; Thomas, D.; Bonati, L. H.; Coward, L.; Dobson, J.; Ederle, J.; Featherstone, R. F.; Tindall, H.; McCabe, D. J. H.; Wallis, A.; Brooks, M.; Chambers, B.; Chan, A.; Chu, P.; Clark, D.; Dewey, H.; Donnan, G.; Fell, G.; Hoare, M.; Molan, M.; Roberts, A.; Roberts, N.; Beiles, B.; Bladin, C.; Clifford, C.; Grigg, M.; New, G.; Bell, R.; Bower, S.; Chong, W.; Holt, M.; Saunder, A.; Than, P. G.; Gett, S.; Leggett, D.; McGahan, T.; Quinn, J.; Ray, M.; Wong, A.; Woodruff, P.; Foreman, R.; Schultz, D.; Scroop, R.; Stanley, B.; Allard, B.; Atkinson, N.; Cambell, W.; Davies, S.; Field, P.; Milne, P.; Mitchell, P.; Tress, B.; Yan, B.; Beasley, A.; Dunbabin, D.; Stary, D.; Walker, S.; Cras, P.; d'Archambeau, O.; Hendriks, J. M. H.; van Schil, P.; St Blasius, A. Z.; Bosiers, M.; Deloose, K.; van Buggenhout, E.; de Letter, J.; Devos, V.; Ghekiere, J.; Vanhooren, G.; Astarci, P.; Hammer, F.; Lacroix, V.; Peeters, A.; Verbist, J.; Blair, J.-F.; Caron, J. L.; Daneault, N.; Giroux, M.-F.; Guilbert, F.; Lanthier, S.; Lebrun, L.-H.; Oliva, V.; Raymond, J.; Roy, D.; Soulez, G.; Weill, A.; Hill, M.; Hu, W.; Hudion, M.; Morrish, W.; Sutherland, G.; Wong, J.; Albäck, A.; Harno, H.; Ijäs, P.; Kaste, M.; Lepäntalo, M.; Mustanoja, S.; Paananen, T.; Porras, M.; Putaala, J.; Railo, M.; Sairanen, T.; Soinne, L.; Vehmas, A.; Vikatmaa, P.; Goertler, M.; Halloul, Z.; Skalej, M.; Brennan, P.; Kelly, C.; Leahy, A.; Moroney, J.; Thornton, J.; Koelemay, M. J. W.; Reekers, J. A. A.; Roos, Y. B. W. E. M.; Hendriks, J. M.; Koudstaal, P. J.; Pattynama, P. M. T.; van der Lugt, A.; van Dijk, L. C.; van Sambeek, M. R. H. M.; van Urk, H.; Verhagen, H. J. M.; Bruijninckx, C. M. A.; de Bruijn, S. F.; Keunen, R.; Knippenberg, B.; Mosch, A.; Treurniet, F.; van Dijk, L.; van Overhagen, H.; Wever, J.; de Beer, F. C.; van den Berg, J. S. P.; van Hasselt, B. A. A. M.; Zeilstra, D. J.; Boiten, J.; van Otterloo, J. C. A. de Mol; de Vries, A. C.; Lycklama a Nijeholt, G. J.; van der Kallen, B. F. W.; Blankensteijn, J. D.; de Leeuw, F. E.; Kool, L. J. Schultze; van der Vliet, J. A.; de Borst, G. J.; de Kort, G. A. P.; Kapelle, L. J.; Lo, T. H.; Mali, W. P. Th M.; Moll, F.; van der Worp, H. B.; Verhagen, H.; Barber, P. A.; Bourchier, R.; Hill, A.; Holden, A.; Stewart, J.; Bakke, S. J.; Krohg-Sørensen, K.; Skjelland, M.; Tennøe, B.; Bialek, P.; Biejat, Z.; Czepiel, W.; Czlonkowska, A.; Dowzenko, A.; Jedrzejewska, J.; Kobayashi, A.; Lelek, M.; Polanski, J.; Kirbis, J.; Milosevic, Z.; Zvan, B.; Blasco, J.; Chamorro, A.; Macho, J.; Obach, V.; Riambau, V.; San Roman, L.; Branera, J.; Canovas, D.; Estela, Jordi; Gaibar, A. Gimenez; Perendreu, J.; Björses, K.; Gottsater, A.; Ivancev, K.; Maetzsch, T.; Sonesson, B.; Berg, B.; Delle, M.; Formgren, J.; Gillgren, P.; Kall, T.-B.; Konrad, P.; Nyman, N.; Takolander, R.; Andersson, T.; Malmstedt, J.; Soderman, M.; Wahlgren, C.; Wahlgren, N.; Binaghi, S.; Hirt, L.; Michel, P.; Ruchat, P.; Engelter, S. T.; Fluri, F.; Guerke, L.; Jacob, A. L.; Kirsch, E.; Lyrer, P. A.; Radue, E.-W.; Stierli, P.; Wasner, M.; Wetzel, S.; Bonvin, C.; Kalangos, A.; Lovblad, K.; Murith, M.; Ruefenacht, D.; Sztajzel, R.; Higgins, N.; Kirkpatrick, P. J.; Martin, P.; Varty, K.; Adam, D.; Bell, J.; Crowe, P.; Gannon, M.; Henderson, M. J.; Sandler, D.; Shinton, R. A.; Scriven, J. M.; Wilmink, T.; D'Souza, S.; Egun, A.; Guta, R.; Punekar, S.; Seriki, D. M.; Thomson, G.; Brennan, J. A.; Enevoldson, T. P.; Gilling-Smith, G.; Gould, D. A.; Harris, P. L.; McWilliams, R. G.; Nasser, H.-C.; White, R.; Prakash, K. G.; Serracino-Inglott, F.; Subramanian, G.; Symth, J. V.; Walker, M. G.; Clarke, M.; Davis, M.; Dixit, S. A.; Dorman, P.; Dyker, A.; Ford, G.; Golkar, A.; Jackson, R.; Jayakrishnan, V.; Lambert, D.; Lees, T.; Louw, S.; Macdonald, S.; Mendelow, A. D.; Rodgers, H.; Rose, J.; Stansby, G.; Wyatt, M.; Baker, T.; Baldwin, N.; Jones, L.; Mitchell, D.; Munro, E.; Thornton, M.; Baker, D.; Davis, N.; Hamilton, G.; McCabe, D.; Platts, A.; Tibballs, J.; Cleveland, T.; Dodd, D.; Lonsdale, R.; Nair, R.; Nassef, A.; Nawaz, S.; Venables, G.; Belli, A.; Cloud, G.; Halliday, A.; Markus, H.; McFarland, R.; Morgan, R.; Pereira, A.; Thompson, A.; Chataway, J.; Cheshire, N.; Gibbs, R.; Hammady, M.; Jenkins, M.; Malik, I.; Wolfe, J.; Adiseshiah, M.; Bishop, C.; Brew, S.; Brookes, J.; Jäger, R.; Kitchen, N.; Ashleigh, R.; Butterfield, S.; Gamble, G. E.; McCollum, C.; Nasim, A.; O'Neill, P.; Edwards, R. D.; Lees, K. R.; MacKay, A. J.; Moss, J.

    2010-01-01

    BACKGROUND: Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. METHODS: The International

  2. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study) : an interim analysis of a randomised controlled trial

    NARCIS (Netherlands)

    Ederle, Joerg; Dobson, Joanna; Featherstone, Roland L.; Bonati, Leo H.; van der Worp, H. Bart; de Borst, Gert J.; Lo, T. Hauw; Gaines, Peter; Dorman, Paul J.; Macdonald, Sumaira; Lyrer, Philippe A.; Hendriks, Johanna M.; McCollum, Charles; Nederkoorn, Paul J.; Brown, Martin M.; Algra, A.; Bamford, J.; Beard, J.; Bland, M.; Bradbury, A. W.; Brown, M. M.; Clifton, A.; Gaines, P.; Hacke, W.; Halliday, A.; Malik, I.; Mas, J. L.; McGuire, A. J.; Sidhu, P.; Venables, G.; Bradbury, A.; Brown, M. M.; Clifton, A.; Gaines, P.; Collins, R.; Molynewc, A.; Naylor, R.; Warlow, C.; Ferro, J. M.; Thomas, D.; Bonati, L. H.; Coward, L.; Dobson, J.; Ederle, J.; Featherstone, R. F.; Tindall, H.; McCabe, D. J. H.; Wallis, A.; Hendriks, J. M. H.; Hendriks, J. M.

    2010-01-01

    Background Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. Methods The International Carotid

  3. "You can save time if…"-A qualitative study on internal factors slowing down clinical trials in Sub-Saharan Africa.

    Directory of Open Access Journals (Sweden)

    Nerina Vischer

    Full Text Available The costs, complexity, legal requirements and number of amendments associated with clinical trials are rising constantly, which negatively affects the efficient conduct of trials. In Sub-Saharan Africa, this situation is exacerbated by capacity and funding limitations, which further increase the workload of clinical trialists. At the same time, trials are critically important for improving public health in these settings. The aim of this study was to identify the internal factors that slow down clinical trials in Sub-Saharan Africa. Here, factors are limited to those that exclusively relate to clinical trial teams and sponsors. These factors may be influenced independently of external conditions and may significantly increase trial efficiency if addressed by the respective teams.We conducted sixty key informant interviews with clinical trial staff working in different positions in two clinical research centres in Kenya, Ghana, Burkina Faso and Senegal. The study covered English- and French-speaking, and Eastern and Western parts of Sub-Saharan Africa. We performed thematic analysis of the interview transcripts.We found various internal factors associated with slowing down clinical trials; these were summarised into two broad themes, "planning" and "site organisation". These themes were consistently mentioned across positions and countries. "Planning" factors related to budget feasibility, clear project ideas, realistic deadlines, understanding of trial processes, adaptation to the local context and involvement of site staff in planning. "Site organisation" factors covered staff turnover, employment conditions, career paths, workload, delegation and management.We found that internal factors slowing down clinical trials are of high importance to trial staff. Our data suggest that adequate and coherent planning, careful assessment of the setting, clear task allocation and management capacity strengthening may help to overcome the identified

  4. Rheumatology telephone advice line - experience of a Portuguese department.

    Science.gov (United States)

    Ferreira, R; Marques, A; Mendes, A; da Silva, J A

    2015-01-01

    Telephone helplines for patients are tool for information and advice. They can contribute to patient's satisfaction with care and to the effectiveness and safety of treatments. In order to achieve this, they need to be adequately adapted to the target populations, as to incorporate their abilities and expectations. a) Evaluate the adherence of patients to a telephone helpline managed by nurses in a Portuguese Rheumatology Department, b) Analyse the profile of users and their major needs, c) Analyse the management of calls by the nurses. The target population of this phone service are the patients treated at Day Care Hospital and Early Arthritis Clinic of our department. Nurses answered phone calls immediately between 8am and 4pm of working days. In the remaining hours messages were recorded on voice mail and answered as soon as possible. Details of the calls were registered in a dedicated sheet and patients were requested permission to use data to improve the service, with respect for their rights of confidentiality, anonymity and freedom of decision. In 18 months 173 calls were made by 79 patients, with a mean age of 47.9 years (sd=9.13). Considering the proportions of men and women in the target population, it was found that men called more frequently (M= 32.7% vs F= 20.4%, p=.016). The reasons for these calls can be divided into three categories: instrumental help, such as the request for results of complementary tests or rescheduling appointments (43.9% of calls); counselling on side effects or worsening of the disease/pain (31.2 %); counselling on therapy management (24.9%). Neither sex nor patient age were significantly related to these reasons for calling. Nurses resolved autonomously half (50.3%) of the calls and in 79.8% of the cases there was no need for patient referral to other health services. About a quarter of patients adhered to the telephone helpline.. Patients called to obtain support in the management of disease and therapy or to report side

  5. Definitions, End Points, and Clinical Trial Designs for Non-Muscle-Invasive Bladder Cancer: Recommendations From the International Bladder Cancer Group

    NARCIS (Netherlands)

    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.

    2016-01-01

    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

  6. Management of optic neuritis and impact of clinical trials: an international survey

    DEFF Research Database (Denmark)

    Biousse, Valérie; Calvetti, Olivier; Drews-Botsch, Carolyn D

    2009-01-01

    OBJECTIVE: 1) To evaluate the management of acute isolated optic neuritis (ON) by ophthalmologists and neurologists; 2) to evaluate the impact of clinical trials; 3) to compare these practices among 7 countries. METHODS: A survey on diagnosis and treatment of acute isolated ON was sent to 5,443 n...... ON patients according to the best evidence from clinical research. This confirms that evaluation of the impact of major clinical trials ("translational T2 clinical research") is essential when assessing the effects of interventions designed to improve quality of care....

  7. Determination of the underlying cause of death in three multicenter international HIV clinical trials

    DEFF Research Database (Denmark)

    Lifson, Alan R; Lundgren, Jens; Belloso, Waldo H

    2008-01-01

    PURPOSE: Describe processes and challenges for an Endpoint Review Committee (ERC) in determining and adjudicating underlying causes of death in HIV clinical trials. METHOD: Three randomized HIV trials (two evaluating interleukin-2 and one treatment interruption) enrolled 11,593 persons from 36...... information or supporting documentation to determine cause of death. Half (51%) of deaths reviewed by the ERC required follow-up adjudication; consensus was eventually always reached. CONCLUSION: ERCs can successfully provide blinded, independent, and systematic determinations of underlying cause of death...

  8. Why do we choose rheumatology? Implications for future recruitment--results of the 2006 UK Trainee Survey.

    Science.gov (United States)

    Dunkley, L; Filer, A; Speden, D; Bax, D; Crisp, A

    2008-06-01

    Against changes to junior doctor career structure under MMC (Modernizing Medical Careers), and uncertainty about the future place of rheumatology, we explored critical factors in choice of rheumatology as a speciality, and asked what factors might govern choices of prospective trainees. Using these data, we developed suggestions to enhance future recruitment. A postal survey was sent to rheumatology specialist registrars (SpRs) on the Joint Committee for Higher Medical Training (JCHMT) database between December 2005 and January 2006, and concurrently by e-mail to the Rheumatologists at Training e-mail list. Seventy-three percent (165/227) of trainees responded. Of them, 89.1% had previous senior house officer (SHO) experience in rheumatology and 81.8% made a career decision in favour of rheumatology during their SHO post. The top four ranked factors influencing choice of rheumatology were SHO experience, subject matter, inspirational consultants and lifestyle aspects; 89.1% would still choose rheumatology now. Factors felt to be negatively influencing future trainees came under three key themes: poor student or postgraduate exposure, employment and service delivery issues (including concern over the future place of rheumatology in primary vs secondary care), and perceived poor profile of rheumatology. Factors positively influencing future candidates were subject matter, work/life balance and prior exposure to the speciality. Early postgraduate experience is key to choice of speciality. An overwhelming majority of trainees decide speciality during SHO experience. With ongoing changes in career structure, it is critical that rheumatology is incorporated into foundation and speciality training programmes and essential that continued measures are taken to improve the image of rheumatology.

  9. 2015 Gout classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative

    Science.gov (United States)

    Neogi, Tuhina; Jansen, Tim L Th A; Dalbeth, Nicola; Fransen, Jaap; Schumacher, H Ralph; Berendsen, Dianne; Brown, Melanie; Choi, Hyon; Edwards, N Lawrence; Janssens, Hein J E M; Lioté, Frédéric; Naden, Raymond P; Nuki, George; Ogdie, Alexis; Perez-Ruiz, Fernando; Saag, Kenneth; Singh, Jasvinder A; Sundy, John S; Tausche, Anne-Kathrin; Vaquez-Mellado, Janitzia; Yarows, Steven A; Taylor, William J

    2015-01-01

    Objective Existing criteria for the classification of gout have suboptimal sensitivity and/or specificity, and were developed at a time when advanced imaging was not available. The current effort was undertaken to develop new classification criteria for gout. Methods An international group of investigators, supported by the American College of Rheumatology and the European League Against Rheumatism, conducted a systematic review of the literature on advanced imaging of gout, a diagnostic study in which the presence of monosodium urate monohydrate (MSU) crystals in synovial fluid or tophus was the gold standard, a ranking exercise of paper patient cases, and a multi-criterion decision analysis exercise. These data formed the basis for developing the classification criteria, which were tested in an independent data set. Results The entry criterion for the new classification criteria requires the occurrence of at least one episode of peripheral joint or bursal swelling, pain, or tenderness. The presence of MSU crystals in a symptomatic joint/bursa (ie, synovial fluid) or in a tophus is a sufficient criterion for classification of the subject as having gout, and does not require further scoring. The domains of the new classification criteria include clinical (pattern of joint/bursa involvement, characteristics and time course of symptomatic episodes), laboratory (serum urate, MSU-negative synovial fluid aspirate), and imaging (double-contour sign on ultrasound or urate on dual-energy CT, radiographic gout-related erosion). The sensitivity and specificity of the criteria are high (92% and 89%, respectively). Conclusions The new classification criteria, developed using a data-driven and decision-analytic approach, have excellent performance characteristics and incorporate current state-of-the-art evidence regarding gout. PMID:26359487

  10. Secondary Prevention of Cardiovascular Disease in Patients With Type 2 Diabetes Mellitus: International Insights From the TECOS Trial (Trial Evaluating Cardiovascular Outcomes With Sitagliptin).

    Science.gov (United States)

    Pagidipati, Neha J; Navar, Ann Marie; Pieper, Karen S; Green, Jennifer B; Bethel, M Angelyn; Armstrong, Paul W; Josse, Robert G; McGuire, Darren K; Lokhnygina, Yuliya; Cornel, Jan H; Halvorsen, Sigrun; Strandberg, Timo E; Delibasi, Tuncay; Holman, Rury R; Peterson, Eric D

    2017-09-26

    Intensive risk factor modification significantly improves outcomes for patients with diabetes mellitus and cardiovascular disease. However, the degree to which secondary prevention treatment goals are achieved in international clinical practice is unknown. Attainment of 5 secondary prevention parameters-aspirin use, lipid control (low-density lipoprotein cholesterol diabetes mellitus and known cardiovascular disease at entry into TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin). Logistic regression was used to evaluate the association between individual and regional factors and secondary prevention achievement at baseline. Cox proportional hazards regression analysis was used to determine the association between baseline secondary prevention achievement and cardiovascular death, myocardial infarction, or stroke. Overall, 29.9% of patients with diabetes mellitus and cardiovascular disease achieved all 5 secondary prevention parameters at baseline, although 71.8% achieved at least 4 parameters. North America had the highest proportion (41.2%), whereas Western Europe, Eastern Europe, and Latin America had proportions of ≈25%. Individually, blood pressure control (57.9%) had the lowest overall attainment, whereas nonsmoking status had the highest (89%). Over a median 3.0 years of follow-up, a higher baseline secondary prevention score was associated with improved outcomes in a step-wise graded relationship (adjusted hazard ratio, 0.60; 95% confidence interval, 0.47-0.77 for those patients achieving all 5 measures versus those achieving ≤2). In an international trial population, significant opportunities exist to improve the quality of cardiovascular secondary prevention care among patients with diabetes mellitus and cardiovascular disease, which in turn could lead to reduced risk of downstream cardiovascular events. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00790205. © 2017 American Heart Association, Inc.

  11. "Big Data" in Rheumatology: Intelligent Data Modeling Improves the Quality of Imaging Data.

    Science.gov (United States)

    Landewé, Robert B M; van der Heijde, Désirée

    2018-05-01

    Analysis of imaging data in rheumatology is a challenge. Reliability of scores is an issue for several reasons. Signal-to-noise ratio of most imaging techniques is rather unfavorable (too little signal in relation to too much noise). Optimal use of all available data may help to increase credibility of imaging data, but knowledge of complicated statistical methodology and the help of skilled statisticians are required. Clinicians should appreciate the merits of sophisticated data modeling and liaise with statisticians to increase the quality of imaging results, as proper imaging studies in rheumatology imply more than a supersensitive imaging technique alone. Copyright © 2018 Elsevier Inc. All rights reserved.

  12. Nursing, occupational therapy, and physical therapy preparation in rheumatology in the United States and Canada.

    Science.gov (United States)

    Jette, A M; Becker, M C

    1980-11-01

    Directors of undergraduate programs in nursing, physical therapy, and occupational therapy in the United States and Canada were surveyed to determine the amount and perceived adequacy of the current degree of classroom and clinical exposure to the rheumatic diseases. One hundred ninety-one (73%) of the 262 mailed questionnaires were returned. Results indicate that regardless of the actual degree of rheumatologic classroom exposure, directors in all three disciplines view current amounts as adequate. A larger proportion views levels of clinical exposure as inadequate. In general, the Canadian programs had a greater emphasis on rheumatology than their United States counterparts.

  13. Competitor presence reduces internal attentional focus and improves 16.1km cycling time trial performance.

    Science.gov (United States)

    Williams, Emily L; Jones, Hollie S; Andy Sparks, S; Marchant, David C; Midgley, Adrian W; Mc Naughton, Lars R

    2015-07-01

    Whilst the presence of a competitor has been found to improve performance, the mechanisms influencing the change in selected work rates during direct competition have been suggested but not specifically assessed. The aim was to investigate the physiological and psychological influences of a visual avatar competitor during a 16.1-km cycling time trial performance, using trained, competitive cyclists. Randomised cross-over design. Fifteen male cyclists completed four 16.1km cycling time trials on a cycle ergometer, performing two with a visual display of themselves as a simulated avatar (FAM and SELF), one with no visual display (DO), and one with themselves and an opponent as simulated avatars (COMP). Participants were informed the competitive avatar was a similar ability cyclist but it was actually a representation of their fastest previous performance. Increased performance times were evident during COMP (27.8±2.0min) compared to SELF (28.7±1.9min) and DO (28.4±2.3min). Greater power output, speed and heart rate were apparent during COMP trial than SELF (pperformance. Competitive cyclists performed significantly faster during a 16.1-km competitive trial than when performing maximally, without a competitor. The improvement in performance was elicited due to a greater external distraction, deterring perceived exertion. Copyright © 2014 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  14. Extraordinary Exceptions at the International Criminal Court : The (New) Rules and Jurisprudence on Presence at Trial

    NARCIS (Netherlands)

    Knottnerus, Abel S.

    2014-01-01

    After their election as President and Vice-President of Kenya, Uhuru Kenyatta and William Ruto asked to be excused from continuous presence during their trials at the ICC. This request raised difficult questions for the Court’s Judges. First, can the accused be excused or is continuous presence a

  15. Hip protectors: recommendations for conducting clinical trials--an international consensus statement (part II)

    DEFF Research Database (Denmark)

    Cameron, I D; Robinovitch, S; Birge, S

    2010-01-01

    While hip protectors are effective in some clinical trials, many, including all in community settings, have been unable to demonstrate effectiveness. This is due partly to differences in the design and analysis. The aim of this report is to develop recommendations for subsequent clinical research....

  16. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction

    NARCIS (Netherlands)

    M.L. Simoons (Maarten); E.J. Topol (Eric); R.M. Califf (Robert); F.J.J. van de Werf (Frans); P.W. Armstrong (Paul); P.E. Aylward (Philip Edmund); G.I. Barbash; E.R. Bates (Eric); A. Betriu; J.H. Chesebro (James); J.J. Col (Jacques); D.P. de Bono (David); J.M. Gore (Joel); A.D. Guerci (Alan); J.R. Hampton (John)

    1993-01-01

    textabstractBACKGROUND: The relative efficacy of streptokinase and tissue plasminogen activator and the roles of intravenous as compared with subcutaneous heparin as adjunctive therapy in acute myocardial infarction are unresolved questions. The current trial was designed to compare new, aggressive

  17. Development of the Paris Definition of Early Crohn's Disease for Disease-Modification Trials: Results of an International Expert Opinion Process

    NARCIS (Netherlands)

    Peyrin-Biroulet, Laurent; Billioud, Vincent; D'Haens, Geert; Panaccione, Remo; Feagan, Brian; Panés, Julian; Danese, Silvio; Schreiber, Stefan; Ogata, Haruhiko; Hibi, Toshifumi; Higgins, Peter D. R.; Beaugerie, Laurent; Chowers, Yehuda; Louis, Edouard; Steinwurz, Flávio; Reinisch, Walter; Rutgeerts, Paul; Colombel, Jean-Frédéric; Travis, Simon; Sandborn, William J.

    2012-01-01

    We report the findings and outputs of an international expert opinion process to develop a definition of early Crohn's disease (CD) that could be used in future disease-modification trials. Nineteen experts on inflammatory bowel diseases held an international expert opinion meeting to discuss and

  18. The role of mineral elements and other chemical compounds used in balneology: data from double-blind randomized clinical trials

    Science.gov (United States)

    Morer, Carla; Roques, Christian-François; Françon, Alain; Forestier, Romain; Maraver, Francisco

    2017-12-01

    The aims of this study were to conduct a systematic literature review on balneotherapy about the specific therapeutic role of mineral elements and other chemical compounds of mineral waters and derivate peloids/muds and to discuss the study methods used to evaluate it (in musculoskeletal conditions). We searched Medline by PubMed using the following key words: "spa therapy" "balneotherapy" "mud" "peloid" "mud pack Therapy" in combination with "randomized controlled trial" "double blind trial." We also reviewed the reference list of articles retrieved by the Medline search. We selected the double-blind randomized clinical trials that assessed the effects of mineral water or mud treatments compared to tap water, attenuated peloid/mud therapy or similar treatments without the specific minerals or chemical compounds of the treatment group ("non-mineral"). We evaluated the internal validity and the quality of the statistical analysis of these trials. The final selection comprised 27 double-blind randomized clinical trials, 20 related to rheumatology. A total of 1118 patients with rheumatological and other musculoskeletal diseases were evaluated in these studies: 552 of knee osteoarthritis, 47 of hand osteoarthritis, 147 chronic low back pain, 308 of reumathoid arthritis, and 64 of osteoporosis; 293 of these participants were assigned to the experimental groups of knee osteoarthritis, 24 in hand osteoarthritis, 82 of low back pain, 152 with reumathoid arthritis, and 32 with osteoporosis. They were treated with mineral water baths and/or mud/peloid (with or without other forms of treatment, like physical therapy, exercise…). The rest were allocated to the control groups; they received mainly tap water and/or "non-mineral" mud/peloid treatments. Mineral water or mud treatments had better and longer improvements in pain, function, quality of life, clinical parameters, and others in some rheumatologic diseases (knee and hand osteoarthritis, chronic low back pain

  19. SONOlysis in prevention of Brain InfaRctions During Internal carotid Endarterectomy (SONOBIRDIE) trial - study protocol for a randomized controlled trial.

    Science.gov (United States)

    Hrbáč, Tomáš; Netuka, David; Beneš, Vladimír; Nosáľ, Vladimír; Kešnerová, Petra; Tomek, Aleš; Fadrná, Táňa; Beneš, Vladimír; Fiedler, Jiří; Přibáň, Vladimír; Brozman, Miroslav; Langová, Kateřina; Herzig, Roman; Školoudík, David

    2017-01-17

    Carotid endarterectomy (CEA) is a beneficial procedure for selected patients with an internal carotid artery (ICA) stenosis. Surgical risk of CEA varies from between 2 and 15%. The aim of the study is to demonstrate the safety and effectiveness of sonolysis (continual transcranial Doppler monitoring, TCD) using a 2-MHz diagnostic probe with maximal diagnostic energy on the reduction of the incidence of stroke, transient ischemic attack (TIA) and brain infarction detected using magnetic resonance imaging (MRI) by the activation of the endogenous fibrinolytic system during CEA. Design: a multicenter, randomized, double-blind, sham-controlled trial. international, multicenter trial for patients with at least 70% symptomatic or asymptomatic ICA stenosis undergoing CEA. patients with symptomatic or asymptomatic ICA stenosis of at least 70% are candidates for CEA; a sufficient temporal bone window for TCD; aged 40-85 years, functionally independent; provision of signed informed consent. Randomization: consecutive patients will be assigned to the sonolysis or control (sham procedure) group by computer-generated 1:1 randomization. Prestudy calculations showed that a minimum of 704 patients in each group is needed to reach a significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8 assuming that 10% would be lost to follow-up or refuse to participate in the study (estimated 39 endpoints). the primary endpoint is the incidence of stroke or TIA during 30 days after CEA and the incidence of new ischemic lesions on brain MRI performed 24 h after CEA in the sonolysis and control groups. Secondary endpoints are occurrence of death, any stroke, or myocardial infarction within 30 days, changes in cognitive functions 1 year post procedure related to pretreatment scores, and number of new lesions and occurrence of new lesions ≥0.5 mL on post-procedural brain MRI. descriptive statistics and linear/logistic multiple regression models will be

  20. Mentoring of young professionals in the field of rheumatology in Europe: results from an EMerging EUlar NETwork (EMEUNET) survey

    NARCIS (Netherlands)

    Frank-Bertoncelj, Mojca; Hatemi, Gulen; Ospelt, Caroline; Ramiro, Sofia; Machado, Pedro; Mandl, Peter; Gossec, Laure; Buch, Maya H.

    2014-01-01

    To explore perceptions of, participation in and satisfaction with mentoring programmes among young clinicians and researchers in rheumatology in Europe. To identify mentoring needs and expectations focusing on gender-specific differences. A survey on mentoring in rheumatology was distributed to

  1. A review of the literature analyzing benefits and concerns of infliximab biosimilar CT-P13 for the treatment of rheumatologic diseases: focus on interchangeability

    Directory of Open Access Journals (Sweden)

    Becciolini A

    2017-06-01

    Full Text Available Andrea Becciolini,1 Maria Gabriella Raimondo,2 Chiara Crotti,2 Elena Agape,2 Martina Biggioggero,2 Ennio Giulio Favalli1 1Department of Rheumatology, 2Department of Clinical Sciences and Health Community, University of Milan, Division of Rheumatology, Gaetano Pini Institute, Milan, Italy Abstract: The introduction of biological agents drastically changed the treatment paradigm of inflammatory arthritides, ameliorating the natural history of the diseases but concomitantly increasing the drug costs due to the manufacturing process. On this concern, biosimilar drugs may represent a valid option for reducing this elevated cost and increasing the availability of these highly effective treatments. Recently, CT-P13, the first biosimilar of infliximab, has been approved with the same indications established for the reference product (RP, and its daily use is progressively increasing. However, the experience with biosimilar drugs in the field of rheumatology is still limited, raising potential doubts and concerns on their correct management in real-life settings. Comparability analysis between CT-P13 and its RP was evaluated in equivalence randomized controlled trials (RCTs – PLANETRA and PLANETAS – performed on patients with rheumatoid arthritis and axial spondylitis, respectively. CT-P13 and RP showed similar profile in terms of quality, biological activity, safety, immunogenicity, and efficacy. However, the interchangeability between infliximab RP and its biosimilar still represents the most challenging issue because of a lack of a long-lasting experience. To date, reassuring preliminary data on this topic were reported in open-label extensions of PLANETRA and PLANETAS RCTs and in ongoing real-life observational studies. These findings, taken all together, significantly affect the landscape of biosimilar regulatory pathways and strongly support CT-P13 introduction as a great opportunity for expanding the accessibility to these very effective and

  2. Results of a Prospective Echocardiography Trial in International Space Station Crew

    Science.gov (United States)

    Hamilton, Douglas R.; Sargsyan, Ashot E.; Martin, David; Garcia, Kathleen M.; Melton, Shannon; Feiverson, Alan; Dulchavsky, Scott A.

    2009-01-01

    In the framework of an operationally oriented investigation, we conducted a prospective trial of a standard clinical echocardiography protocol in a cohort of long-duration crewmembers. The resulting primary and processed data appear to have no precedents. Our tele-echocardiography paradigm, including just-in-time e-training methods, was also assessed. A critical review of the imaging technique, equipment and setting limitations, and quality assurance is provided, as well as the analysis of "space normal" data.

  3. Clinical Marginal and Internal Adaptation of Maxillary Anterior Single All-Ceramic Crowns and 2-year Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Akın, Aslı; Toksavul, Suna; Toman, Muhittin

    2015-07-01

    The aims of this randomized-controlled clinical trial were to compare marginal and internal adaptation of all-ceramic crowns fabricated with CAD/CAM and heat-pressed (HP) techniques before luting and to evaluate the clinical outcomes at baseline and at 6, 12, and 24 months after luting. Fifteen CAD/CAM (CC) and 15 HP all-ceramic crowns were placed in 15 patients. A silicone replica was obtained to measure marginal and internal adaptation of each all-ceramic crown before luting, and they were sectioned buccolingually and mesiodistally. Marginal and internal adaptations were measured using computerized light microscope at 40× magnification. Clinical evaluations took place at baseline (2 days after luting) and at 6, 12, and 24 months after luting. Replica scores were analyzed with Mann-Whitney U and Student's t-test (α = 0.05). Survival rate of crowns was determined using Kaplan-Meier statistical analysis. The median marginal gap for the CC group was 132.2 μm and was 130.2 μm for the HP group. The mean internal adaptation for the CC group was 220.3 ± 51.3 μm and 210.5 ± 31 μm for the HP group. There were no statistically significant differences with respect to marginal opening (Mann-Whitney U test; p = 0.95) and internal adaptation (Student's t-test; p = 0.535) between the 2 groups. Based on modified Ryge criteria, 100% of the crowns were rated satisfactory during the 2-year period. In this in vivo study, CAD/CAM and HP all-ceramic crowns exhibited similar marginal and internal adaptations. A 100% success rate was recorded for the 15 CAD/CAM and for the 15 HP all-ceramic crowns during the 2-year period. © 2014 by the American College of Prosthodontists.

  4. International Study to Predict Optimized Treatment for Depression (iSPOT-D, a randomized clinical trial: rationale and protocol

    Directory of Open Access Journals (Sweden)

    Cooper Nicholas J

    2011-01-01

    Full Text Available Abstract Background Clinically useful treatment moderators of Major Depressive Disorder (MDD have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine; and develop a model that incorporates multiple predictors and moderators. Methods/Design The International Study to Predict Optimized Treatment - in Depression (iSPOT-D is a multi-centre, international, randomized, prospective, open-label trial. It is enrolling 2016 MDD outpatients (ages 18-65 from primary or specialty care practices (672 per treatment arm; 672 age-, sex- and education-matched healthy controls. Study-eligible patients are antidepressant medication (ADM naïve or willing to undergo a one-week wash-out of any non-protocol ADM, and cannot have had an inadequate response to protocol ADM. Baseline assessments include symptoms; distress; daily function; cognitive performance; electroencephalogram and event-related potentials; heart rate and genetic measures. A subset of these baseline assessments are repeated after eight weeks of treatment. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary and self-reported depressive symptoms, social functioning, quality of life, emotional regulation, and side-effect burden (secondary. Participants may then enter a naturalistic telephone follow-up at weeks 12, 16, 24 and 52. The first half of the sample will be used to identify potential predictors and moderators, and the second half to replicate and confirm. Discussion First enrolment was in December 2008, and is ongoing. iSPOT-D evaluates clinical and biological predictors of treatment response in the largest known sample of MDD collected worldwide. Trial registration International Study to Predict Optimised Treatment - in Depression (iSPOT-D ClinicalTrials.gov Identifier

  5. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  6. Advanced practice physiotherapy-led triage in Irish orthopaedic and rheumatology services: national data audit.

    LENUS (Irish Health Repository)

    Fennelly, Orna

    2018-06-01

    Many people with musculoskeletal (MSK) disorders wait several months or years for Consultant Doctor appointments, despite often not requiring medical or surgical interventions. To allow earlier patient access to orthopaedic and rheumatology services in Ireland, Advanced Practice Physiotherapists (APPs) were introduced at 16 major acute hospitals. This study performed the first national evaluation of APP triage services.

  7. The impact factor of rheumatology journals : an analysis of 2008 and the recent 10 years

    NARCIS (Netherlands)

    Chen, Min; Zhao, Ming-Hui; Kallenberg, Cees G. M.

    2011-01-01

    Despite various weaknesses, the impact factor (IF) is still used as an important indictor for scientific quality in specific subject categories. In the current study, the IFs of rheumatology journals over the past 10 years were serially analyzed and compared with that from other fields. For the past

  8. Impact of healthcare design on patients' perception of a rheumatology outpatient infusion room

    DEFF Research Database (Denmark)

    Bukh, Gunhild; Tommerup, Anne Marie Munk; Madsen, Ole Rintek

    2015-01-01

    Evidence-based healthcare design is a concept aimed at reducing stress factors in the physical environment for the benefit of patients and the medical staff. The objective of this study was to examine the impact of room modifications on patients' perception of an outpatient infusion room used...... the potential to improve patients' perception of outpatient infusion rooms used for treating rheumatologic diseases....

  9. Advanced practice physiotherapy-led triage in Irish orthopaedic and rheumatology services: national data audit.

    Science.gov (United States)

    Fennelly, Orna; Blake, Catherine; FitzGerald, Oliver; Breen, Roisin; Ashton, Jennifer; Brennan, Aisling; Caffrey, Aoife; Desmeules, François; Cunningham, Caitriona

    2018-06-01

    Many people with musculoskeletal (MSK) disorders wait several months or years for Consultant Doctor appointments, despite often not requiring medical or surgical interventions. To allow earlier patient access to orthopaedic and rheumatology services in Ireland, Advanced Practice Physiotherapists (APPs) were introduced at 16 major acute hospitals. This study performed the first national evaluation of APP triage services. Throughout 2014, APPs (n = 22) entered clinical data on a national database. Analysis of these data using descriptive statistics determined patient wait times, Consultant Doctor involvement in clinical decisions, and patient clinical outcomes. Chi square tests were used to compare patient clinical outcomes across orthopaedic and rheumatology clinics. A pilot study at one site identified re-referral rates to orthopaedic/rheumatology services of patients managed by the APPs. In one year, 13,981 new patients accessed specialist orthopaedic and rheumatology consultations via the APP. Median wait time for an appointment was 5.6 months. Patients most commonly presented with knee (23%), lower back (22%) and shoulder (15%) disorders. APPs made autonomous clinical decisions regarding patient management at 77% of appointments, and managed patient care pathways without onward referral to Consultant Doctors in more than 80% of cases. Other onward clinical pathways recommended by APPs were: physiotherapy referrals (42%); clinical investigations (29%); injections administered (4%); and surgical listing (2%). Of those managed by the APP, the pilot study identified that only 6.5% of patients were re-referred within one year. This national evaluation of APP services demonstrated that the majority of patients assessed by an APP did not require onward referral for a Consultant Doctor appointment. Therefore, patients gained earlier access to orthopaedic and rheumatology consultations in secondary care, with most patients conservatively managed.

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

    NARCIS (Netherlands)

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

    2017-01-01

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

  11. Mupirocin for the reduction of colonization of internal jugular cannulae: a randomized controlled trial

    NARCIS (Netherlands)

    R.L.R. Hill; A. P. Fisher; R. J. Ware; S. Wilson (Susan); M. W. Casewell

    1990-01-01

    textabstractIn a prospective study, 218 cardiothoracic patients, in whom 'Abbocath-T' cannulae had been inserted preoperatively into the internal jugular vein, were randomized to receive skin preparation of the insertion site with tincture of iodine (108 controls) or tincture of iodine followed by

  12. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus

    DEFF Research Database (Denmark)

    Petri, Michelle; Orbai, Ana-Maria; Alarcón, Graciela S

    2012-01-01

    The Systemic Lupus International Collaborating Clinics (SLICC) group revised and validated the American College of Rheumatology (ACR) systemic lupus erythematosus (SLE) classification criteria in order to improve clinical relevance, meet stringent methodology requirements, and incorporate new...

  13. Evidence-Based Soft Tissue Rheumatology IV: Anserine Bursitis.

    Science.gov (United States)

    Alvarez-Nemegyei, Jose; Canoso, Juan J

    2004-08-01

    Anserine bursitis is a frequent cause of medial knee pain. Despite its name, the structure at fault causing the symptoms remains unknown. Diabetes mellitus is a known predisposing factor leading to the condition. Overweight and knee osteoarthritis are possible additional risk factors, but their role has yet to be assessed. Anserine bursitis is diagnosed clinically based on medial knee pain and localized tenderness at the inferomedial knee. Current treatment of anserine bursitis includes nonsteroidal anti-inflammatory dugs, physiotherapy, and local glucocorticoid injections. Of these, only the latter has been shown effective in clinical trials. Knowledge gaps in the epidemiology, pathology, and pathogenesis of anserine bursitis should lead to additional research efforts on this common and perplexing condition.

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

    Directory of Open Access Journals (Sweden)

    Bochenek Andrzej

    2011-09-01

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

  15. Value of internal limiting membrane peeling in surgery for idiopathic macular hole stage 2 and 3: a randomised clinical trial

    DEFF Research Database (Denmark)

    Christensen, U C; Krøyer, K; Sander, B

    2009-01-01

    AIM: To determine the effect of internal limiting membrane (ILM) peeling on anatomical and functional success rates in stage 2 and 3 idiopathic macular hole surgery (MHS). METHODS: Randomised clinical trial of stage 2 and 3 idiopathic macular hole without visible epiretinal fibrosis and with less...... than 1 year's duration of symptoms. Eyes were randomised to (1) vitrectomy alone without retinal surface manipulation, (2) vitrectomy plus 0.05% isotonic Indocyanine Green (ICG)-assisted ILM peeling or (3) vitrectomy plus 0.15% Trypan Blue (TB)-assisted ILM peeling. Main outcomes were hole closure...... after 3 and 12 months and best-corrected visual acuity after 12 months. RESULTS: 78 eyes were enrolled. Primary closure rates were significantly higher with ILM peeling than without peeling for both stage 2 holes (ICG peeling 100%, non-peeling 55%, p = 0.014) and for stage 3 holes (ICG peeling 91%, TB...

  16. Tangential breast irradiation with or without internal mammary chain irradiation: results of a randomized trial

    International Nuclear Information System (INIS)

    Kaija, Holli; Maunu, Pitkaenen

    1995-01-01

    A prospective randomized study was made of 270 patients with unilateral stage I or II invasive breast cancer treated by segmental resection, axillary dissection and radiation at the University Hospital of Tampere, Finland, between 1989 and 1991. The aim of the study was to determine whether there is any advantage or disadvantage if the internal mammary chains (IMC) are included in the radiation target volume. The medial and lateral two-field technique was used and the target volumes were determined randomly either to include the internal mammary chain (IMC-RT) or not (no-IMC-RT). The prevalence of radiation pneumonitis was 16% and there was no significant difference between the IMC- and no-IMC-groups (18 vs. 14%). Skin reactions were equal in both groups. Lung fibrosis was more common in the IMC-RT group. In conclusion: radiation of internal mammary chain after conservative surgery does not lead to an increase in clinically important skin or pulmonary complications. Whether it prevents recurrences or new primaries of the opposite breast is too early to say because of the short follow-up time

  17. Rheumatologic care of nursing home residents with rheumatoid arthritis: a comparison of the year before and after nursing home admission.

    Science.gov (United States)

    Luque Ramos, Andres; Albrecht, Katinka; Zink, Angela; Hoffmann, Falk

    2017-12-01

    The purpose of this study was to investigate health care for patients with rheumatoid arthritis (RA) before and after admission to nursing homes. Data of a German health insurance fund from persons with diagnostic codes of RA, aged ≥65 years, admitted to a nursing home between 2010 and 2014 and continuously insured 1 year before and after admission were used. The proportion of patients with ≥1 rheumatologist visit and ≥1 prescription of biologic or conventional synthetic disease-modifying antirheumatic drugs (bDMARDs or csDMARDs), glucocorticoids and non-steroidal anti-inflammatory drugs (NSAIDs) in the year before and after admission were calculated. Predictors of rheumatologic care after admission were analyzed by multivariable logistic regression. Of 75,697 nursing home residents, 2485 (3.3%) had RA (90.5% female, mean age 83.8). Treatment by rheumatologists and prescription of antirheumatic drugs decreased significantly in the year after admission (rheumatologic visits: 17.6 to 9.1%, bDMARDs: 2.1 to 1.5%, csDMARDs: 22.5 to 16.5%, glucocorticoids: 46.5 to 43.1%, NSAIDs: 47.4 to 38.5%). 60.2% of patients in rheumatologic care received csDMARDs compared with 14.5% without rheumatologic care. Rheumatologic care before admission to a nursing home strongly predicted rheumatologic care thereafter (OR 33.8, 95%-CI 23.2-49.2). Younger age and lower care level (reflecting need of help) were also associated with a higher chance of rheumatologic care. Rheumatologic care is already infrequent in old patients with RA and further decreases after admission to a nursing home. Patients without rheumatologic care are at high risk of insufficient treatment for their RA. Admission to a nursing home further increases this risk.

  18. Recommendations of the Brazilian Society of Rheumatology for the diagnosis and treatment of chikungunya fever. Part 2 - Treatment

    Directory of Open Access Journals (Sweden)

    Claudia Diniz Lopes Marques

    Full Text Available Abstract Chikungunya fever has become an important public health problem in countries where epidemics occur because half of the cases progress to chronic, persistent and debilitating arthritis. Literature data on specific therapies at the various phases of arthropathy caused by chikungunya virus (CHIKV infection are limited, lacking quality randomized trials assessing the efficacies of different therapies. There are a few studies on the treatment of musculoskeletal manifestations of chikungunya fever, but these studies have important methodological limitations. The data currently available preclude conclusions favorable or contrary to specific therapies, or an adequate comparison between the different drugs used. The objective of this study was to develop recommendations for the treatment of chikungunya fever in Brazil. A literature review was performed via evidence-based selection of articles in the databases Medline, SciELO, PubMed and Embase and conference proceedings abstracts, in addition to expert opinions to support decision-making in defining recommendations. The Delphi method was used to define the degrees of agreement in 2 face-to-face meetings and several online voting rounds. This study is part 2 of the Recommendations of the Brazilian Society of Rheumatology (Sociedade Brasileira de Reumatologia - SBR for the Diagnosis and Treatment of chikungunya fever and specifically addresses treatment.

  19. Ankylosing Spondylitis Patients Commencing Biologic Therapy Have High Baseline Levels of Comorbidity: A Report from the Australian Rheumatology Association Database

    Directory of Open Access Journals (Sweden)

    John Oldroyd

    2009-01-01

    Full Text Available Aims. To compare the baseline characteristics of a population-based cohort of patients with ankylosing spondylitis (AS commencing biological therapy to the reported characteristics of bDMARD randomised controlled trials (RCTs participants. Methods. Descriptive analysis of AS participants in the Australian Rheumatology Association Database (ARAD who were commencing bDMARD therapy. Results. Up to December 2008, 389 patients with AS were enrolled in ARAD. 354 (91.0% had taken bDMARDs at some time, and 198 (55.9% completed their entry questionnaire prior to or within 6 months of commencing bDMARDs. 131 (66.1% had at least one comorbid condition, and 24 (6.8% had a previous malignancy (15 nonmelanoma skin, 4 melanoma, 2 prostate, 1 breast, cervix, and bowel. Compared with RCT participants, ARAD participants were older, had longer disease duration and higher baseline disease activity. Conclusions. AS patients commencing bDMARDs in routine care are significantly different to RCT participants and have significant baseline comorbidities.

  20. Prevention of fatal postoperative pulmonary embolism by low doses of heparin. An international multicentre trial.

    Science.gov (United States)

    1975-07-12

    The efficacy of low-dose heparin in preventing fatal postoperative pulmonary embolism has been investigated in a multicentre prospective randomised trial. 4121 patients over the age of forty years undergoing a variety of elective major surgical procedures were included in the trial; 2076 of these were in the control group and 2045 patients received heparin. The two groups were well matched for age, sex, weight, blood-group, and other factors which could predispose to the development of venous thromboembolism. 180 (4-4 %) patients died during the postoperative period, 100 in the control and 80 in the heparin group: 72% of deaths in the control and 66% in the heparin group had necropsy examination. 16 patients in the control group and 2 in the heparin group were found at necropsy to have died due to acute massive pulmonary embolism (P smaller than 0-005). In addition, emboli found at necropsy in 6 patients in the control group and 3 in the heparin group were considered either contributory to death or an incidental finding since death in these patients was attributed to other causes. Taking all pulmonary emboli together, the findings were again significant (P smaller than 0-005). Of 1292 patients in whom the 125-I-fibrinogen test was performed to detect deep-vein thrombosis (D.V.T.) 667 were in the control group and 625 in the heparin group. The frequency of isotopic D.V.T. was reduced from 24-6% in the control group 7-7% in the heparin group (P smaller 0-005). In 30 patients D.V.T. was detected at necropsy; 24 in the control and 6 in the heparin group (P smaller 0-005). 32 patients in the control group and 11 in the heparin group developed clinically diagnosed D.V.T. which was confirmed by venography (P smaller than 0-005). In addition, 24 patients in the control and 8 in the heparin group were treated for clinically suspected pulmonary emoblism. The difference in the number of patients requiring treatment for D.V.T. and/or pulmonary embolism in the two groups was

  1. Greater focus on clinical rheumatology is required for training in internal medicine.

    LENUS (Irish Health Repository)

    McCarthy, Eoghan M

    2012-02-01

    Early intervention for rheumatic disease has been shown to improve prognosis, but is dependent on the recognition of pertinent symptoms and signs. This study was undertaken to identify the attitudes of junior doctors toward musculoskeletal assessment. The charts of 100 randomly selected medical patients admitted via the Emergency Department were reviewed for documentation of the musculoskeletal system. In addition, junior doctors were interviewed regarding their views on musculoskeletal assessment. Only 16% of medical admission notes contained a reference to the musculoskeletal system and the recording of joint examinations was incomplete in all cases. Prior training in musculoskeletal assessment depended on the joint area involved (hand, 100%; foot, 36.2%). Most doctors felt competent in hand assessment (68.8%) but only 12.5% could examine the foot. More than one third could not confidently diagnose common rheumatic conditions, while 75% felt unable to diagnose a connective tissue disorder. The majority (88.7%) regarded the musculoskeletal assessment as difficult\\/challenging and 61.3% thought that it should not be included as part of a general medical examination. However, 80% of doctors felt that they had not received adequate teaching in musculoskeletal assessment and would welcome further training. The omission of the musculoskeletal assessment for medical patients admitted to hospital is reflected in the fact that doctors lack training in this area. Furthermore, doctors lack confidence in their ability to recognise both common and rare rheumatic diagnoses, a problem likely to impact adversely on the outcome of patients with these conditions.

  2. The role of prophylactic internal iliac artery ligation in abnormally invasive placenta undergoing caesarean hysterectomy: a randomized control trial.

    Science.gov (United States)

    Hussein, Ahmed M; Dakhly, Dina Mohamed Refaat; Raslan, Ayman N; Kamel, Ahmed; Abdel Hafeez, Ali; Moussa, Manal; Hosny, Ahmed Samir; Momtaz, Mohamed

    2018-04-25

    To identify the role of bilateral internal iliac artery (IIA) ligation on reducing blood loss in abnormally invasive placenta (AIP) undergoing caesarean hysterectomy. In this parallel-randomized control trial, 57 pregnant females with ultrasound features suggestive of AIP were enrolled. They were randomized into two groups; IIA group (n = 29 cases) performed bilateral IIA ligation followed by caesarean hysterectomies, while Control group (n = 28 cases) underwent caesarean hysterectomy only. The main outcome was the difference in the estimated intraoperative blood loss between the two groups. There was no significant difference between the two groups regarding the intraoperative estimated blood loss (1632 ± 804 versus 1698 ± 1251, p value .83). The operative procedure duration (minutes) (223 ± 66 versus 171 ± 41.4, p value .001) varied significantly between the two groups. Bilateral internal iliac artery ligation, in cases of AIP undergoing caesarean hysterectomy, is not recommended for routine practice to minimize blood loss intraoperatively.

  3. A report from the American college of rheumatology/association of rheumatology health professionals (ACR/ARHP) - 2012 annual meeting (November 9-14, 2012 - Washington, D.C., USA).

    Science.gov (United States)

    Croasdell, G

    2013-02-01

    The annual meeting of the American College of Rheumatology (ACR), jointly held with the Association of Rheumatology Health Professionals (ARHP), brought together attendees focused on all aspects of rheumatology, including researchers looking into treatment options and various services around the care of rheumatologic conditions. As well as networking opportunities at the meeting, there were a wide range of symposia and posters available covering various conditions and levels of research. There were also educational and meet-the-professor sessions. This report will cover a selection of interesting talks from poster and oral sessions on the latest preclinical and clinical research. Copyright 2013 Prous Science, S.A.U. or its licensors. All rights reserved.

  4. How do we perceive activity pacing in rheumatology care?

    DEFF Research Database (Denmark)

    Cuperus, N.; Vliet Vlieland, T.; Brodin, N.

    2015-01-01

    goals of activity pacing, behaviours of activity pacing (the actions people take to meet the goal of activity pacing), strategies to change behaviour in activity pacing (for example goal setting) and contextual factors that should be acknowledged when instructing activity pacing. Besides, topics......-management programs. However, despite its wide endorsement in clinical practice, to date activity pacing is still a poorly understood concept. Objectives: To achieve consensus by means of an international Delphi exercise on the most important aspects of activity pacing as an intervention within non...... for future research on activity pacing were formulated and prioritized. Results: Of the 60 panelists, nearly two third (63%) completed all four Delphi rounds. The panel prioritized 9 goals, 11 behaviours, 9 strategies to change behaviour and 10 contextual factors of activity pacing. These items were...

  5. Double blind, placebo-controlled trial of Tranexamic acid on recent internal hemorrhoid bleeding

    Directory of Open Access Journals (Sweden)

    Abdul A. Rani

    2002-12-01

    Full Text Available Double blind randomized placebo controlled trial was conducted to evaluate the efficacy of Tranexamic acid in 54 patients with recent hemorrhoid bleeding. Age, gender, body weight, height, grade of hemorrhoid, time of onset of recent bleeding were comparable between two groups. Analysis of haemostatic effect or stop bleeding as an immediate outcome of this study revealed that in the grade 2 patients, 23/23 (100% of tranexamic group and 18/23(78.26% of placebo group the bleeding stop. After 3 days of observation, there was statistically significant different for the rate of stop bleeding as well as at the end of observation. Bleeding stop earlier in the Tranexamic group with median 4 days (3-5 days, compare to placebo, median 11(9.55-12.45. Analysis of recurrent bleeding as an outcome of this study revealed that in the placebo group 9/18(50% of grade 2 patients and all grade 3 (100%patients suffered from recurrent bleeding. Since the days 4, both group have significant different time for recurrent bleeding and at the end of observation, cumulative probability of free of bleeding between two groups significantly different. Median still stop bleeding in the placebo group was 36 days, and the tranexamic group never reaches the median until the end of observation. Conclusion: tranexamic acid was an effective drug to stop recent hemorrhoid bleeding and prevent further recurrent bleeding, significantly better than placebo. (Med J Indones 2002;11: 215-21Keywords: Tranexamic acid, hemorrhoid bleeding, haemostatic effect, recurrent bleeding.

  6. Framework for Advancing the Reporting of Patient Engagement in Rheumatology Research Projects.

    Science.gov (United States)

    Hamilton, Clayon B; Leese, Jenny C; Hoens, Alison M; Li, Linda C

    2017-07-01

    The term "patient engagement in research" refers to patients and their surrogates undertaking roles in the research process beyond those of study participants. This paper proposes a new framework for describing patient engagement in research, based on analysis of 30 publications related to patient engagement. Over the past 15 years, patients' perspectives have been instrumental in broadening the scope of rheumatology research and outcome measurement, such as evaluating fatigue in rheumatoid arthritis. Recent reviews, however, highlight low-quality reporting of patient engagement in research. Until we have more detailed information about patient engagement in rheumatology research, our understanding of how patients' perspectives are being integrated into research projects remains limited. When authors follow our guidance on the important components for describing patients' roles and function as "research partners," researchers and other knowledge users will better understand how patients' perspectives were integrated in their research projects.

  7. Achieving serum urate targets in gout: an audit in a gout-oriented rheumatology practice.

    Science.gov (United States)

    Corbett, Elizabeth J M; Pentony, Peta; McGill, Neil W

    2017-07-01

    To assess the proportion of patients with gout who achieve target serum urate levels, the drug regime required and the reasons for failing to do so. We reviewed the files of all patients with gout who presented to a gout-oriented rheumatology practice between January 2010 and September 2014. Two hundred and thirty patients agreed to commence urate lowering therapy (ULT); 73% achieved their urate target, including 74% with non-tophaceous gout (target ≤ 0.36 mmol/L) and 71% with tophi (target ≤ 0.30 mmol/L). Of the 62 who failed to reach target, in 61 it was due to non-adherence and in one due to inefficacy. Adherence remains the major challenge to successful long-term gout management. © 2017 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

  8. Biosimilars in rheumatology: recommendations for regulation and use in Middle Eastern countries.

    Science.gov (United States)

    El Zorkany, Bassel; Al Ani, Nizar; Al Emadi, Samar; Al Saleh, Jamal; Uthman, Imad; El Dershaby, Yasser; Mounir, Mohamed; Al Moallim, Hani

    2018-05-01

    The increasing availability of biosimilar medicines in Middle Eastern regions may provide an opportunity to increase the number of rheumatology patients who have access to traditionally more expensive biologic medicines. However, as well as a lack of real-world data on the use of biosimilar medicines in practice, the availability of intended copies in the region may undermine physician confidence in prescribing legitimate biosimilar medicines. There is a need for regional recommendations for healthcare professionals to ensure that biosimilar drugs can be used safely. Therefore, a literature search was performed with the aim of providing important recommendations for the regulation and use of biosimilar medicines in the Middle East from key opinion leaders in rheumatology from the region. These recommendations focus on improving the availability of relevant real-world data, ensuring that physicians are aware of the difference between intended copies and true biosimilars and ensuring that physicians are responsible for making any prescribing and switching decisions.

  9. Management of gout by UK rheumatologists: a British Society for Rheumatology national audit.

    Science.gov (United States)

    Roddy, Edward; Packham, Jon; Obrenovic, Karen; Rivett, Ali; Ledingham, Joanna M

    2018-05-01

    To assess the concordance of gout management by UK rheumatologists with evidence-based best-practice recommendations. Data were collected on patients newly referred to UK rheumatology out-patient departments over an 8-week period. Baseline data included demographics, method of diagnosis, clinical features, comorbidities, urate-lowering therapy (ULT), prophylaxis and blood tests. Twelve months later, the most recent serum uric acid level was collected. Management was compared with audit standards derived from the 2006 EULAR recommendations, 2007 British Society for Rheumatology/British Health Professionals in Rheumatology guideline and the National Institute for Health and Care Excellence febuxostat technology appraisal. Data were collected for 434 patients from 91 rheumatology departments (mean age 59.8 years, 82% male). Diagnosis was crystal-proven in 13%. Of 106 taking a diuretic, this was reduced/stopped in 29%. ULT was continued/initiated in 76% of those with one or more indication for ULT. One hundred and fifty-eight patients started allopurinol: the starting dose was most commonly 100 mg daily (82%); in those with estimated glomerular filtration rate <60 ml/min the highest starting dose was 100 mg daily. Of 199 who started ULT, prophylaxis was co-prescribed for 94%. Fifty patients started a uricosuric or febuxostat: 84% had taken allopurinol previously. Of 44 commenced on febuxostat, 18% had a history of heart disease. By 12 months, serum uric acid levels ⩽360 and <300 μmol/l were achieved by 45 and 25%, respectively. Gout management by UK rheumatologists concords well with guidelines for most audit standards. However, fewer than half of patients achieved a target serum uric level over 12 months. Rheumatologists should help ensure that ULT is optimized to achieve target serum uric acid levels to benefit patients.

  10. [Structural quality of rheumatology clinics for children and adolescents. Paper by a task force of the "Society of Pediatric and Adolescent Rheumatology" and of the "Association of Rheumatology Clinics in Germany"].

    Science.gov (United States)

    Michels, H; Ganser, G; Dannecker, G; Forster, J; Häfner, R; Horneff, G; Küster, R M; Lakomek, H-J; Lehmann, H; Minden, K; Rogalski, B; Schöntube, M

    2006-07-01

    Rheumatic diseases in childhood and adolescence differ from those of adulthood according to type, manifestation, treatment and course. A specialized therapy, starting as early as possible, improves the prognosis, can prevent long-term damage and saves the costs of long-term care. Only a specialized pediatric care system can guarantee optimum quality of the processes involved and the results for rheumatology in childhood and adolescence within a global financial system. This requires adequate structural quality of the specialized clinics and departments for pediatric rheumatology. The management of rheumatic diseases in childhood and adolescence is comprehensive and requires a multidisciplinary, specialized and engaged team which can cover the whole spectrum of rheumatic diseases with their various age-dependent aspects. In order to guarantee an adequate, cost-efficient routine, a specialized center which concentrates on inpatient care should treat at least 300 patients with pediatric rheumatic diseases per year. The diagnoses should be divided among the various disease categories with at least 70% of them involving inflammatory rheumatic diseases. For the inpatient care of small children, an accompanying person (parent) is necessary, requiring adequate structures and services. Patient rooms as well as diagnostic (radiography, sonography, etc.) and therapeutic services (physiotherapy, occupational therapy, pool, etc.) must be adequate for small children and school children as well as adolescents. Suitable mother-child units must also be provided and a school for patients is required within the clinic. A pediatric rheumatologist must be available 24 h a day, and it must be possible to reach other specialists within a short time. For painful therapeutic procedures, age-appropriate pain management is obligatory. A continuous adjustment of these recommendations to changing conditions in health politics is intended.

  11. Development of the Paris definition of early Crohn's disease for disease-modification trials: results of an international expert opinion process.

    Science.gov (United States)

    Peyrin-Biroulet, Laurent; Billioud, Vincent; D'Haens, Geert; Panaccione, Remo; Feagan, Brian; Panés, Julian; Danese, Silvio; Schreiber, Stefan; Ogata, Haruhiko; Hibi, Toshifumi; Higgins, Peter D R; Beaugerie, Laurent; Chowers, Yehuda; Louis, Edouard; Steinwurz, Flávio; Reinisch, Walter; Rutgeerts, Paul; Colombel, Jean-Frédéric; Travis, Simon; Sandborn, William J

    2012-12-01

    We report the findings and outputs of an international expert opinion process to develop a definition of early Crohn's disease (CD) that could be used in future disease-modification trials. Nineteen experts on inflammatory bowel diseases held an international expert opinion meeting to discuss and agree on a definition for early CD to be used in disease-modification trials. The process included literature searches for the relevant basic-science and clinical evidence. A published preliminary definition of early CD was used as the basis for development of a proposed definition that was discussed at the expert opinion meeting. The participants then derived a final definition, based on best current knowledge, that it is hoped will be of practical use in disease-modification trials in CD.

  12. Obesity and risk of recurrence or death after adjuvant endocrine therapy with letrozole or tamoxifen in the breast international group 1-98 trial

    DEFF Research Database (Denmark)

    Ewertz, Marianne; Gray, Kathryn P; Regan, Meredith M

    2012-01-01

    To examine the association of baseline body mass index (BMI) with the risk of recurrence or death in postmenopausal women with early-stage breast cancer receiving adjuvant tamoxifen or letrozole in the Breast International Group (BIG) 1-98 trial at 8.7 years of median follow-up....

  13. Evaluation of Subcutaneous Proleukin (interleukin-2) in a Randomized International Trial (ESPRIT): geographical and gender differences in the baseline characteristics of participants

    NARCIS (Netherlands)

    Pett, S. L.; Wand, H.; Law, M. G.; Arduino, R.; Lopez, J. C.; Knysz, B.; Pereira, L. C.; Pollack, S.; Reiss, P.; Tambussi, G.

    2006-01-01

    BACKGROUND: ESPRIT, is a phase III, open-label, randomized, international clinical trial evaluating the effects of subcutaneous recombinant interleukin-2 (rIL-2) plus antiretroviral therapy (ART) versus ART alone on HIV-disease progression and death in HIV-1-infected individuals with CD4+ T-cells >

  14. Position paper from the Spanish Society of Rheumatology on biosimilar drugs.

    Science.gov (United States)

    Abad Hernández, Miguel Ángel; Andreu, José Luis; Caracuel Ruiz, Miguel Ángel; Belmonte Serrano, Miguel Ángel; Díaz-González, Federico; Moreno Muelas, José Vicente

    2015-01-01

    A biosimilar (BS) is a biological drug that contains a version of the active substance of an already authorized original biological product. The BSs are marketed after patent period of the original drug has ended and once it has been demonstrated that the differences regarding the innovative medicine have no relevant effect on its safety or clinical efficacy. The Spanish Society of Rheumatology, in line with the European Medicines Agency, considers that because of its nature and complexity of production, a BS cannot be considered to be the same as a generic drug. The Spanish Society of Rheumatology expresses an unequivocal commitment to the sustainability of the health system in our country and our steadfast alignment with all measures designed to ensure continuity, without reducing the quality of care. Therefore, we believe that the advent of BSs will likely facilitate access of patients with rheumatic diseases to the biological drugs. This article reviews the European Medicines Agency requirements for authorization, the Spanish legal framework and controversies on BS and presents the position paper of the Spanish Society of Rheumatology on these drugs. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  15. Viewpoints of dentists on the use of bisphosphonates in rheumatology patients.

    Science.gov (United States)

    Daron, Coline; Deschaumes, Christophe; Soubrier, Martin; Mathieu, Sylvain

    2018-02-15

    Alhough typically prescribed in oncology, bisphosphonates (BPs) are also employed in rheumatology, particularly for the treatment of osteoporosis, sometimes resulting in complications, such as osteonecrosis of the jaw. Because of different opinions between rheumatologists and dentists on BP use, this study aimed to assess the views of dentists regarding administration of BPs in rheumatology. A questionnaire was sent to 880 dentists from the Auvergne region of France to determine their views on BP treatment. We obtained 382 (43.4%) responses and analysed 376 (58.7% men). In total, 156 (41.5%) of the responders analysed had attended an in-service training course (ISTC) on the topic. A total of 237 (63.0%) systematically inquired as to whether their patients were undergoing BP treatment; this proportion was higher among those who had been practicing for fewer than 10 years (P ISTC (62.6% vs. 50.7%; P < 0.03). Dentists feel ill at ease providing dental surgery to patients receiving BPs. Closer collaboration and better information-sharing between rheumatologists and dentists is necessary to facilitate the administration of BPs in rheumatology. © 2018 FDI World Dental Federation.

  16. Assessment of email communication skills of rheumatology fellows: a pilot study

    Science.gov (United States)

    Dhuper, Sonal; Siva, Chokkalingam; Fresen, John L; Petruc, Marius; Velázquez, Celso R

    2010-01-01

    Physician–patient email communication is gaining popularity. However, a formal assessment of physicians' email communication skills has not been described. We hypothesized that the email communication skills of rheumatology fellows can be measured in an objective structured clinical examination (OSCE) setting using a novel email content analysis instrument which has 18 items. During an OSCE, we asked 50 rheumatology fellows to respond to a simulated patient email. The content of the responses was assessed using our instrument. The majority of rheumatology fellows wrote appropriate responses scoring a mean (±SD) of 10.6 (±2.6) points (maximum score 18), with high inter-rater reliability (0.86). Most fellows were concise (74%) and courteous (68%) but not formal (22%). Ninety-two percent of fellows acknowledged that the patient's condition required urgent medical attention, but only 30% took active measures to contact the patient. No one encrypted their messages. The objective assessment of email communication skills is possible using simulated emails in an OSCE setting. The variable email communication scores and incidental patient safety gaps identified, suggest a need for further training and defined proficiency standards for physicians' email communication skills. PMID:20962134

  17. Unique topics and issues in rheumatology and clinical immunology.

    Science.gov (United States)

    Selmi, Carlo

    2014-08-01

    Clinicians are facing unexpected issues in everyday practice, and these may become counterintuitive or challenging. Illustrative examples are provided by the hypersensitivity to universally used immunosuppressants such as corticosteroids or antibiotics such as beta-lactam. Secondly, additional issues are represented by the discovery of new pathogenetic mechanisms involved in rheumatoid and psoriatic arthritis or other chronic inflammatory diseases, genomic susceptibility to enigmatic diseases such as giant cell arteritis, or the shared role of specific mediators such as semaphorins. Third, the therapeutic armamentarium has dramatically changed over the past decade following the introduction of biotechnological drugs, and new mechanisms are being proposed to reduce adverse events or increase the drug effectiveness, particularly on cardiovascular comorbidities. Finally, rare diseases continue to represent difficult cases, as for Cogan's syndrome, with limited literature available for clinical recommendations. For these reason, the present issue of Clinical Reviews in Allergy and Immunology is timely and dedicated to these and other unique topics in clinical immunology and allergy. The aim of this issue is thus to help clinicians involved in internal medicine as well as allergists and clinical immunologists while discussing new pathways that will prove important in the near future.

  18. LASIK for myopia and astigmatism using the SCHWIND AMARIS excimer laser: an international multicenter trial.

    Science.gov (United States)

    Arbelaez, Maria Clara; Aslanides, Ioannis M; Barraquer, Carmen; Carones, Francesco; Feuermannova, Alena; Neuhann, Tobias; Rozsival, Pavel

    2010-02-01

    To assess the efficacy, predictability, and safety of LASIK for the surgical correction of low to moderate myopia with astigmatism using the SCHWIND AMARIS excimer laser. Six international study sites enrolled 358 eyes with a manifest refraction spherical equivalent (MRSE) from -0.50 to -7.38 diopters (D) (mean sphere: -3.13+/-1.58 D) with up to -5.00 D of astigmatism (mean: -0.69+/-0.67 D). All eyes underwent treatment with the nonwavefront-guided aspheric algorithm of the SCHWIND AMARIS excimer laser. All eyes were targeted for emmetropia. Refractive outcomes and corneal higher order aberrations were analyzed pre- and postoperatively. Visual quality was assessed using photopic and mesopic contrast sensitivity. Six-month postoperative outcomes are reported. At 6 months postoperative, the MRSE for all eyes was -0.21+/-0.20 D, and 96% (343/358) of eyes had MRSE within +/-0.50 D. Uncorrected visual acuity was 20/20 or better in 98% (351/358) of eyes, and no eyes lost 2 or more lines of best spectacle-corrected visual acuity. The total corneal higher order aberrations root-mean-square increased by 0.09 microm, spherical aberration increased by 0.08 microm, and coma increased by 0.04 microm postoperatively. Photopic and mesopic contrast sensitivity did not change 6 months postoperatively. Treatment of myopia with astigmatism using the SCHWIND AMARIS excimer laser is safe, efficacious, predictable, and maintains visual quality.

  19. Rheumatology education for undergraduate nursing, physiotherapy and occupational therapy students in the UK: standards, challenges and solutions

    OpenAIRE

    Hewlett, S.; Clarke, B.; O?Brien, A.; Hammond, A.; Ryan, S.; Kay, L.; Richards, P.; Almeida, C.

    2008-01-01

    Objectives. Rheumatological conditions are common, thus nurses (Ns) occupational therapists (OTs) and physiotherapists (PTs) require at least basic rheumatology knowledge upon qualifying. The aim of this study was to develop a core set of teaching topics and potential ways of delivering them. Methods. A modified Delphi technique was used for clinicians to develop preliminary core sets of teaching topics for each profession. Telephone interviews with educationalists explored their views on the...

  20. Treatment Adherence and Its Impact on Disease-Free Survival in the Breast International Group 1-98 Trial of Tamoxifen and Letrozole, Alone and in Sequence

    DEFF Research Database (Denmark)

    Chirgwin, Jacquie H; Giobbie-Hurder, Anita; Coates, Alan S

    2016-01-01

    PURPOSE: To investigate adherence to endocrine treatment and its relationship with disease-free survival (DFS) in the Breast International Group (BIG) 1-98 clinical trial. METHODS: The BIG 1-98 trial is a double-blind trial that randomly assigned 6,193 postmenopausal women with hormone receptor......-positive early breast cancer in the four-arm option to 5 years of tamoxifen (Tam), letrozole (Let), or the agents in sequence (Let-Tam, Tam-Let). This analysis included 6,144 women who received at least one dose of study treatment. Conditional landmark analyses and marginal structural Cox proportional hazards......). Sequential treatments were associated with higher rates of nonpersistence (Tam-Let, 20.8%; Let-Tam, 20.3%; Tam 16.9%; Let 17.6%). Adverse events were the reason for most trial treatment early discontinuations (82.7%). Apart from sequential treatment assignment, reduced adherence was associated with older age...

  1. PREVENTION OF CONVERSION TO ABNORMAL TCD WITH HYDROXYUREA IN SICKLE CELL ANEMIA: A PHASE III INTERNATIONAL RANDOMIZED CLINICAL TRIAL

    Science.gov (United States)

    Hankins, Jane S.; McCarville, M. Beth; Rankine-Mullings, Angela; Reid, Marvin E.; Lobo, Clarisse L.C.; Moura, Patricia G.; Ali, Susanna; Soares, Deanne; Aldred, Karen; Jay, Dennis W.; Aygun, Banu; Bennett, John; Kang, Guolian; Goldsmith, Jonathan C.; Smeltzer, Matthew P.; Boyett, James M.; Ware, Russell E.

    2015-01-01

    Children with sickle cell anemia (SCA) and conditional transcranial Doppler (TCD) ultrasound velocities (170-199 cm/sec) may develop stroke. However, with limited available clinical data, the current standard of care for conditional TCD velocities is observation. The efficacy of hydroxyurea in preventing conversion from conditional to abnormal TCD (≥200 cm/sec), which confers a higher stroke risk, has not been studied prospectively in a randomized trial. Sparing Conversion to Abnormal TCD Elevation (SCATE #NCT01531387) was an NHLBI-funded Phase III multicenter international clinical trial comparing alternative therapy (hydroxyurea) to standard care (observation) to prevent conversion from conditional to abnormal TCD velocity in children with SCA. SCATE enrolled 38 children from the United States, Jamaica, and Brazil [HbSS (36), HbSβ0-thalassemia (1), and HbSD (1), median age 5.4 years (range, 2.7-9.8)]. Due to slow patient accrual and administrative delays, SCATE was terminated early. In an intention-to-treat analysis, the cumulative incidence of abnormal conversion was 9% (95% CI 0 to 35%) in the hydroxyurea arm and 47% (95% CI 6 to 81%) in observation arm at 15 months (p=0.16). In post-hoc analysis according to treatment received, significantly fewer children on hydroxyurea converted to abnormal TCD velocities, compared to observation (0% versus 50%, p=0.02). After a mean of 10.1 months, a significant change in mean TCD velocity was observed with hydroxyurea treatment (−15.5 versus +10.2 cm/sec, p=0.02). No stroke events occurred in either arm. Hydroxyurea reduces TCD velocities in children with SCA and conditional velocities. PMID:26414435

  2. Prevention of conversion to abnormal transcranial Doppler with hydroxyurea in sickle cell anemia: A Phase III international randomized clinical trial.

    Science.gov (United States)

    Hankins, Jane S; McCarville, Mary Beth; Rankine-Mullings, Angela; Reid, Marvin E; Lobo, Clarisse L C; Moura, Patricia G; Ali, Susanna; Soares, Deanne P; Aldred, Karen; Jay, Dennis W; Aygun, Banu; Bennett, John; Kang, Guolian; Goldsmith, Jonathan C; Smeltzer, Matthew P; Boyett, James M; Ware, Russell E

    2015-12-01

    Children with sickle cell anemia (SCA) and conditional transcranial Doppler (TCD) ultrasound velocities (170-199 cm/sec) may develop stroke. However, with limited available clinical data, the current standard of care for conditional TCD velocities is observation. The efficacy of hydroxyurea in preventing conversion from conditional to abnormal TCD (≥200 cm/sec), which confers a higher stroke risk, has not been studied prospectively in a randomized trial. Sparing Conversion to Abnormal TCD Elevation (SCATE #NCT01531387) was a National Heart, Lung, and Blood Institute-funded Phase III multicenter international clinical trial comparing alternative therapy (hydroxyurea) to standard care (observation) to prevent conversion from conditional to abnormal TCD velocity in children with SCA. SCATE enrolled 38 children from the United States, Jamaica, and Brazil [HbSS (36), HbSβ(0) -thalassemia (1), and HbSD (1), median age = 5.4 years (range, 2.7-9.8)]. Because of the slow patient accrual and administrative delays, SCATE was terminated early. In an intention-to-treat analysis, the cumulative incidence of abnormal conversion was 9% (95% CI = 0-35%) in the hydroxyurea arm and 47% (95% CI = 6-81%) in observation arm at 15 months (P = 0.16). In post hoc analysis according to treatment received, significantly fewer children on hydroxyurea converted to abnormal TCD velocities when compared with observation (0% vs. 50%, P = 0.02). After a mean of 10.1 months, a significant change in mean TCD velocity was observed with hydroxyurea treatment (-15.5 vs. +10.2 cm/sec, P = 0.02). No stroke events occurred in either arm. Hydroxyurea reduces TCD velocities in children with SCA and conditional velocities. © 2015 Wiley Periodicals, Inc.

  3. Regional differences in milk and complementary feeding patterns in infants participating in an international nutritional type 1 diabetes prevention trial.

    Science.gov (United States)

    Nucci, Anita M; Virtanen, Suvi M; Sorkio, Susa; Bärlund, Sonja; Cuthbertson, David; Uusitalo, Ulla; Lawson, Margaret L; Salonen, Marja; Berseth, Carol L; Ormisson, Anne; Lehtonen, Eveliina; Savilahti, Erkki; Becker, Dorothy J; Dupré, John; Krischer, Jeffrey P; Knip, Mikael; Åkerblom, Hans K

    2017-07-01

    Differences in breastfeeding, other milk feeding and complementary feeding patterns were evaluated in infants at increased genetic risk with and without maternal type 1 diabetes (T1D). The Trial to Reduce IDDM in the Genetically at Risk is an international nutritional primary prevention double-blinded randomized trial to test whether weaning to extensively hydrolyzed vs. intact cow's milk protein formula will decrease the development of T1D-associated autoantibodies and T1D. Infant diet was prospectively assessed at two visits and seven telephone interviews between birth and 8 months. Countries were grouped into seven regions: Australia, Canada, Northern Europe, Southern Europe, Central Europe I, Central Europe II and the United States. Newborn infants with a first-degree relative with T1D and increased human leukocyte antigen-conferred susceptibility to T1D were recruited. A lower proportion of infants born to mothers with than without T1D were breastfed until 6 months of age in all regions (range, 51% to 60% vs. 70% to 80%). Complementary feeding patterns differed more by region than by maternal T1D. In Northern Europe, a higher proportion of infants consumed vegetables and fruits daily compared with other regions. Consumption of meat was more frequent in all European regions, whereas cereal consumption was most frequent in Southern Europe, Canada and the United States. Maternal T1D status was associated with breastfeeding and other milk feeding patterns similarly across regions but was unrelated to the introduction of complementary foods. Infant feeding patterns differed significantly among regions and were largely inconsistent with current recommended guidelines. © 2016 John Wiley & Sons Ltd.

  4. Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial.

    Science.gov (United States)

    Østerås, Nina; van Bodegom-Vos, Leti; Dziedzic, Krysia; Moseng, Tuva; Aas, Eline; Andreassen, Øyvor; Mdala, Ibrahim; Natvig, Bård; Røtterud, Jan Harald; Schjervheim, Unni-Berit; Vlieland, Thea Vliet; Hagen, Kåre Birger

    2015-12-02

    Previous research indicates that people with osteoarthritis (OA) are not receiving the recommended and optimal treatment. Based on international treatment recommendations for hip and knee OA and previous research, the SAMBA model for integrated OA care in Norwegian primary health care has been developed. The model includes physiotherapist (PT) led patient OA education sessions and an exercise programme lasting 8-12 weeks. This study aims to assess the effectiveness, feasibility, and costs of a tailored strategy to implement the SAMBA model. A cluster randomized controlled trial with stepped wedge design including an effect, process, and cost evaluation will be conducted in six municipalities (clusters) in Norway. The municipalities will be randomized for time of crossover from current usual care to the implementation of the SAMBA model by a tailored strategy. The tailored strategy includes interactive workshops for general practitioners (GPs) and PTs in primary care covering the SAMBA model for integrated OA care, educational material, educational outreach visits, feedback, and reminder material. Outcomes will be measured at the patient, GP, and PT levels using self-report, semi-structured interviews, and register based data. The primary outcome measure is patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire) at 6-month follow-up. Secondary outcomes include referrals to PT, imaging, and referrals to the orthopaedic surgeon as well as participants' treatment satisfaction, symptoms, physical activity level, body weight, and self-reported and measured lower limb function. The actual exposure to the tailor made implementation strategy and user experiences will be measured in a process evaluation. In the economic evaluation, the difference in costs of usual OA care and the SAMBA model for integrated OA care will be compared with the difference in health outcomes and reported by the incremental cost-effectiveness ratio (ICER). The results

  5. Self-management model in the scheduling of successive appointments in rheumatology.

    Science.gov (United States)

    Castro Corredor, David; Cuadra Díaz, José Luis; Mateos Rodríguez, Javier José; Anino Fernández, Joaquín; Mínguez Sánchez, María Dolores; de Lara Simón, Isabel María; Tébar, María Ángeles; Añó, Encarnación; Sanz, María Dolores; Ballester, María Nieves

    2018-01-08

    The rheumatology service of Ciudad Real Hospital, located in an autonomous community of that same name that is nearly in the center of Spain, implemented a self-management model of successive appointments more than 10 years ago. Since then, the physicians of the department schedule follow-up visits for their patients depending on the disease, its course and ancillary tests. The purpose of this study is to evaluate and compare the self-management model for successive appointments in the rheumatology service of Ciudad Real Hospital versus the model of external appointment management implemented in 8 of the hospital's 15 medical services. A comparative and multivariate analysis was performed to identify variables with statistically significant differences, in terms of activity and/or performance indicators and quality perceived by users. The comparison involved the self-management model for successive appointments employed in the rheumatology service of Ciudad Real Hospital and the model for external appointment management used in 8 hospital medical services between January 1 and May 31, 2016. In a database with more than 100,000 records of appointments involving the set of services included in the study, the mean waiting time and the numbers of non-appearances and rescheduling of follow-up visits in the rheumatology department were significantly lower than in the other services. The number of individuals treated in outpatient rheumatology services was 7,768, and a total of 280 patients were surveyed (response rate 63.21%). They showed great overall satisfaction, and the incidence rate of claims was low. Our results show that the self-management model of scheduling appointments has better results in terms of activity indicators and in quality perceived by users, despite the intense activity. Thus, this study could be fundamental for decision making in the management of health care organizations. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de

  6. The United States rheumatology workforce: supply and demand, 2005-2025.

    Science.gov (United States)

    Deal, Chad L; Hooker, Roderick; Harrington, Timothy; Birnbaum, Neal; Hogan, Paul; Bouchery, Ellen; Klein-Gitelman, Marisa; Barr, Walter

    2007-03-01

    To develop and apply a model that allows prediction of current and future supply and demand for rheumatology services in the US. A supply model was developed using the age and sex distribution of current physicians, retirement and mortality rates, the number of fellowship slots and fill rates, and practice patterns of rheumatologists. A Markov projection model was used to project needs in 5-year increments from 2005 to 2025. The number of rheumatologists for adult patients in the US in 2005 is 4,946. Male and female rheumatologists are equally distributed up to age 44; above age 44, men predominate. The percent of women in adult rheumatology is projected to increase from 30.2% in 2005 to 43.6% in 2025. The mean number of visits per rheumatologist per year is 3,758 for male rheumatologists and 2,800 for female rheumatologists. Assuming rheumatology supply and demand are in equilibrium in 2005, the demand for rheumatologists in 2025 is projected to exceed supply by 2,576 adult and 33 pediatric rheumatologists. The primary factors in the excess demand are an aging population which will increase the number of people with rheumatic disorders, growth in the Gross Domestic Product, and flat rheumatology supply due to fixed numbers entering the workforce and to retirements. The productivity of younger rheumatologists and women, who will make up a greater percentage of the future workforce, may also have important effects on supply. Unknown effects that could influence these projections include technology advances, more efficient practice methods, changes in insurance reimbursements, and shifting lifestyles. Current data suggest that the pediatric rheumatology workforce is experiencing a substantial excess of demand versus supply. Based on assessment of supply and demand under current scenarios, the demand for rheumatologists is expected to exceed supply in the coming decades. Strategies for the profession to adapt to this changing health care landscape include increasing

  7. Profile of rheumatology patients willing to report adverse drug reactions: bias from selective reporting

    Directory of Open Access Journals (Sweden)

    Protić D

    2016-02-01

    Full Text Available Dragana Protić,1 Nada Vujasinović-Stupar,2 Zoran Bukumirić,3 Slavica Pavlov-Dolijanović,4 Snežana Baltić,5 Slavica Mutavdžin,6 Ljiljana Markovic-Denić,7 Marija Zdravković,8 Zoran Todorović1 1Department of Pharmacology, Clinical Pharmacology and Toxicology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 2Department 2, Institute of Rheumatology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 3Institute for Medical Statistics and Informatics, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 4Department 5, Institute of Rheumatology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 5Department 5, Institute of Rheumatology, Belgrade, Serbia; 6Institute of Physiology “Rihard Burjan”, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 7Institute of Epidemiology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 8Department of Cardiology, Medical Center “Bežanijska kosa”, Faculty of Medicine, University of Belgrade, Belgrade, Serbia Background: Adverse drug reactions (ADRs have a significant impact on human health and health care costs. The aims of our study were to determine the profile of rheumatology patients willing to report ADRs and to identify bias in such a reporting system. Methods: Semi-intensive ADRs reporting system was used in our study. Patients willing to participate (N=261 completed the questionnaire designed for the purpose of the study at the hospital admission. They were subsequently classified into two groups according to their ability to identify whether they had experienced ADRs during the previous month. Group 1 included 214 out of 261 patients who were able to identify ADRs, and group 2 consisted of 43 out of 261 patients who were not able to identify ADRs in their recent medical history. Results: Group 1 patients were more significantly aware of their diagnosis than the patients from group 2. Marginal significance was found

  8. The Early External Cephalic Version (ECV) 2 Trial: an international multicentre randomised controlled trial of timing of ECV for breech pregnancies.

    Science.gov (United States)

    Hutton, E K; Hannah, M E; Ross, S J; Delisle, M-F; Carson, G D; Windrim, R; Ohlsson, A; Willan, A R; Gafni, A; Sylvestre, G; Natale, R; Barrett, Y; Pollard, J K; Dunn, M S; Turtle, P

    2011-04-01

    To investigate whether initiating external cephalic version (ECV) earlier in pregnancy might increase the rate of successful ECV procedures, and be more effective in decreasing the rate of non-cephalic presentation at birth and of caesarean section. An unblinded multicentred randomised controlled trial. A total of 1543 women were randomised from 68 centres in 21 countries. Women with a singleton breech fetus at a gestational age of 33(0/7) weeks (231 days) to 35(6/7) weeks (251 days) of gestation were included. Participants were randomly assigned to having a first ECV procedure between the gestational ages of 34(0/7) (238 days) and 35(6/7) weeks of gestation (early ECV group) or at or after 37(0/7) (259 days) weeks of gestation (delayed ECV group). The primary outcome was the rate of caesarean section; the secondary outcome was the rate of preterm birth. Fewer fetuses were in a non-cephalic presentation at birth in the early ECV group (314/765 [41.1%] versus 377/768 [49.1%] in the delayed ECV group; relative risk [RR] 0.84, 95% CI 0.75, 0.94, P=0.002). There were no differences in rates of caesarean section (398/765 [52.0%] versus 430/768 [56.0%]; RR 0.93, 95% CI 0.85, 1.02, P=0.12) or in risk of preterm birth (50/765 [6.5%] versus 34/768 [4.4%]; RR 1.48, 95% CI 0.97, 2.26, P=0.07) between groups. External cephalic version at 34-35 weeks versus 37 or more weeks of gestation increases the likelihood of cephalic presentation at birth but does not reduce the rate of caesarean section and may increase the rate of preterm birth. © 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG.

  9. The VICI-trial: high frequency oscillation versus conventional mechanical ventilation in newborns with congenital diaphragmatic hernia: an international multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van den Hout Lieke

    2011-11-01

    Full Text Available Abstract Background Congenital diaphragmatic hernia (CDH is a severe congenital anomaly of the diaphragm resulting in pulmonary hypoplasia and pulmonary hypertension. It is associated with a high risk of mortality and pulmonary morbidity. Previous retrospective studies have reported high frequency oscillatory ventilation (HFO to reduce pulmonary morbidity in infants with CDH, while others indicated HFO to be associated with worse outcome. We therefore aimed to develop a randomized controlled trial to compare initial ventilatory treatment with high-frequency oscillation and conventional ventilation in infants with CDH. Methods/design This trial is designed as a multicentre trial in which 400 infants (200 in each arm will be included. Primary outcome measures are BPD, described as oxygen dependency by day 28 according to the definition of Jobe and Bancalari, and/or mortality by day 28. All liveborn infants with CDH born at a gestational age of over 34 weeks and no other severe congenital anomalies are eligible for inclusion. Parental informed consent is asked antenatally and the allocated ventilation mode starts within two hours after birth. Laboratory samples of blood, urine and tracheal aspirate are taken at the first day of life, day 3, day 7, day 14 and day 28 to evaluate laboratory markers for ventilator-induced lung injury and pulmonary hypertension. Discussion To date, randomized clinical trials are lacking in the field of CDH. The VICI-trial, as the first randomized clinical trial in the field of CDH, may provide further insight in ventilation strategies in CDH patient. This may hopefully prevent mortality and morbidity. Trial registration Netherlands Trial Register (NTR: NTR1310

  10. Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency.

    Science.gov (United States)

    Larson, Gregg S; Baseler, Beth R; Hoover, Marie L; Pierson, Jerome F; Tegli, Jemee K; Johnson, Melvin P; Kieh, Mark W S; McNay, Laura A; Njoh, Wissedi Sio

    2017-07-01

    Clinical trials are challenging endeavors. Planning and implementing an investigational vaccine trial in Liberia, in the midst of an Ebola virus disease (EVD) epidemic that World Health Organization classified a public health emergency of international concern, presented extraordinary challenges. Normally, years of preparation and a litany of tasks lay the groundwork for a successful, randomized, blinded, placebo-controlled trial focused on safety and efficacy. Difficult research settings, unpredictable events, and other unique circumstances can add complexity. The setting in Liberia was especially problematic due to an infrastructure still badly damaged following a lengthy civil war and a very fragile health-care system that was further devastated by the EVD outbreak. The Partnership for Research on Vaccines in Liberia I EVD vaccine trial was planned and implemented in less than 3 months by a Liberian and U.S. research partnership, and its Phase II substudy was fully enrolled 3 months later. Contrasting conventional wisdom with trial outcomes offers an opportunity to compare early assumptions, barriers encountered, and adaptive strategies used, with end results. Understanding what was learned can inform future trial responses when disease outbreaks, especially in resource-poor locations with minimal infrastructure, pose a significant threat to public health.

  11. It is time to revise the international Good Clinical Practices guidelines: recommendations from non-commercial North-South collaborative trials.

    Science.gov (United States)

    Ravinetto, Raffaella; Tinto, Halidou; Diro, Ermias; Okebe, Joseph; Mahendradhata, Yodi; Rijal, Suman; Gotuzzo, Eduardo; Lutumba, Pascal; Nahum, Alain; De Nys, Katelijne; Casteels, Minne; Boelaert, Marleen

    2016-01-01

    The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs). Based on our field experience in LMICs, we developed a non-exhaustive set of recommendations for the improvement of GCP. These cover 3 domains: ethical, legal and operational, and 8 specific issues: the double ethical review of 'externally sponsored' trials; the informed consent procedure in minors and in illiterate people; post-trial access to newly-developed products for the trial communities; the role of communities as key research actors; the definition of sponsor; and the guidance for contractual agreements, laboratory quality management systems, and quality assurance of investigational medicinal products. Issues not covered in our analysis include among others biobanking, standard of care, and study designs. The international GCP codes de facto guide national legislators and funding agencies, so the current shortcomings may weaken the regulatory oversight of international research. In addition, activities neglected by GCP are less likely to be implemented or funded. If GCP are meant to serve the interests of global society, a comprehensive revision is needed. The revised guidelines should be strongly rooted in ethics, sensitive to different sociocultural perspectives, and allow consideration for trial-specific and context-specific challenges. This can be only achieved if all stakeholders, including researchers, sponsors, regulators, ethical reviewers and patients' representatives from LMICs, as well as non-commercial researchers and sponsors from affluent countries, are transparently involved in the revision process. We hope that our limited analysis would foster advocacy for a broad and inclusive revision of the international GCP codes, to make them at the same time 'global

  12. TOPGEAR: a randomised phase III trial of perioperative ECF chemotherapy versus preoperative chemoradiation plus perioperative ECF chemotherapy for resectable gastric cancer (an international, intergroup trial of the AGITG/TROG/EORTC/NCIC CTG)

    International Nuclear Information System (INIS)

    Leong, Trevor; Smithers, B Mark; Michael, Michael; Gebski, Val; Boussioutas, Alex; Miller, Danielle; Simes, John; Zalcberg, John; Haustermans, Karin; Lordick, Florian; Schuhmacher, Christoph; Swallow, Carol; Darling, Gail; Wong, Rebecca

    2015-01-01

    surgical technique. TOPGEAR is an international, intergroup collaboration led by the Australasian Gastro-Intestinal Trials Group (AGITG), in collaboration with the Trans-Tasman Radiation Oncology Group (TROG), European Organisation for Research and Treatment of Cancer (EORTC) and the NCIC Clinical Trials Group. It addresses a globally significant question that will help inform future international standards for clinical practice in resectable gastric cancer

  13. The VICI-trial: high frequency oscillation versus conventional mechanical ventilation in newborns with congenital diaphragmatic hernia: an international multicentre randomized controlled trial.

    Science.gov (United States)

    van den Hout, Lieke; Tibboel, Dick; Vijfhuize, Sanne; te Beest, Harma; Hop, Wim; Reiss, Irwin

    2011-11-02

    Congenital diaphragmatic hernia (CDH) is a severe congenital anomaly of the diaphragm resulting in pulmonary hypoplasia and pulmonary hypertension. It is associated with a high risk of mortality and pulmonary morbidity. Previous retrospective studies have reported high frequency oscillatory ventilation (HFO) to reduce pulmonary morbidity in infants with CDH, while others indicated HFO to be associated with worse outcome. We therefore aimed to develop a randomized controlled trial to compare initial ventilatory treatment with high-frequency oscillation and conventional ventilation in infants with CDH. This trial is designed as a multicentre trial in which 400 infants (200 in each arm) will be included. Primary outcome measures are BPD, described as oxygen dependency by day 28 according to the definition of Jobe and Bancalari, and/or mortality by day 28. All liveborn infants with CDH born at a gestational age of over 34 weeks and no other severe congenital anomalies are eligible for inclusion. Parental informed consent is asked antenatally and the allocated ventilation mode starts within two hours after birth. Laboratory samples of blood, urine and tracheal aspirate are taken at the first day of life, day 3, day 7, day 14 and day 28 to evaluate laboratory markers for ventilator-induced lung injury and pulmonary hypertension. To date, randomized clinical trials are lacking in the field of CDH. The VICI-trial, as the first randomized clinical trial in the field of CDH, may provide further insight in ventilation strategies in CDH patient. This may hopefully prevent mortality and morbidity. Netherlands Trial Register (NTR): NTR1310.

  14. The prevalence of medical nomadism of the followed patients in rheumatology.

    Science.gov (United States)

    Boudali, Aziza; Bahiri, Rachid; Hmamouchi, Ihssane; Abouqal, Redouane; Abouqual, Redouane; Hajjaj Hassouni, Najia

    2012-06-01

    The nomads are defined as patients related to multiple practicians of the same speciality or different specialities for the same symptomatology during a certain period. The objectives of this investigation were to evaluate the prevalence of medical nomadism of the followed patients in rheumatology and compare their profile with those patients followed in neurology and gastroenterology. A multicentric transverse study (September 2009-March 2010) was conducted in three departments of CHU Ibn Sina Rabat-Salé, Morocco; rheumatology, gastroenterology and neurology. Only patients seen in external consultations were included. Patients' socio-economic and demographic background (familial status, instruction level, monthly revenue, social assistance) were recorded, as well as the clinical parameters related to the pathology (pathology, duration of the illness, diagnosis final time). A questionnaire containing variables on the patients' state concerning diagnosis, satisfaction degree of the patients and other variables evaluated the notion of taking medication and the practice of alternative medicine. Medical nomadism has been defined by the consultation for the same symptomatology of three different practicians, either of the same speciality or of different specialities during the study period of 6 months. There were 250 patients included in this study (150 patients in rheumatology, 50 in gastroenterology and 50 in neurology), the mean age was 46 ± 13 years and females dominated (65.6%). The average duration of the evolution was 7 ± 5 years, 35% of the patients were illiterate, 30% had a primary school education, 22% had a secondary school education and 13% had a university-level education. Sixty-two percent of the patients were jobless, 27% were workers, 9% were the functionary and 2% were the based liberal. Fifty-six percent had no social assistance. Rheumatoid arthritis and degenerative pathology were the most frequent diagnoses in rheumatology, being 20% and

  15. International

    International Nuclear Information System (INIS)

    Anon.

    1997-01-01

    This rubric reports on 10 short notes about international economical facts about nuclear power: Electricite de France (EdF) and its assistance and management contracts with Eastern Europe countries (Poland, Hungary, Bulgaria); Transnuclear Inc. company (a 100% Cogema daughter company) acquired the US Vectra Technologies company; the construction of the Khumo nuclear power plant in Northern Korea plays in favour of the reconciliation between Northern and Southern Korea; the delivery of two VVER 1000 Russian reactors to China; the enforcement of the cooperation agreement between Euratom and Argentina; Japan requested for the financing of a Russian fast breeder reactor; Russia has planned to sell a floating barge-type nuclear power plant to Indonesia; the control of the Swedish reactor vessels of Sydkraft AB company committed to Tractebel (Belgium); the renewal of the nuclear cooperation agreement between Swiss and USA; the call for bids from the Turkish TEAS electric power company for the building of the Akkuyu nuclear power plant answered by three candidates: Atomic Energy of Canada Limited (AECL), Westinghouse (US) and the French-German NPI company. (J.S.)

  16. PERICARDIAL FEATURES OF IN-HOSPITAL RHEUMATOLOGY PATIENTS: AN OBSERVATIONAL STUDY.

    Science.gov (United States)

    Bakalli, Aurora; Rexhepi, Mjellma; Rexhepi, Blerta; Koçinaj, Dardan

    Rheumatic disorders can be associated with pericarditis, but severe forms of pericarditis are rare. The aim of this observational study was to evaluate pericardial features in patients with different rheumatic diseases. Thirty-five patients hospitalized at the Clinic of Rheumatology, University Clinical Center of Kosovo, from October 1 to October 21, 2014 were included in the study. Demographic data, history, laboratory, ECG, and echocardiography data, with special emphasis on the analysis of the pericardium, were obtained from each patient. Echocardiography was especially focused on the amount of pericardial fluid and pericardial thickness in the posterior wall of the heart. Mean patient age was 51.5 ± 13.8 years. 65.7% of the patients were women. Out of the patients that we analyzed, 88.6% had an inflammatory rheumatologic disease. 11.3% of the patients had mild symptoms, in 68.7% the symptoms were moderate, and in 20% severe. In all patients, pericardial hyperechogenicity was marked, with a mean pericardial thickness of 4.68 ± 1.66 mm. Pericardial effusion in a small amount was present in 57.1% of patients, with a mean pericardial fluid amount of 3.3 ± 1.9 mm. The severity of rheumatic disease had a positive and significant correlation with the presence of pericardial effusion (r= 0.29, p=0.04) and its amount (r= 0.28, p=0.05). The patients had not been aware of the pericardial involvement and did not have any clinical symptoms. In conclusion, in this short-term small observational study pericardial changes were a frequent finding in the rheumatology patients. In general, the pericarditis was subclinical and with small amounts of effusion. The disease activity of rheumatic disorders can be associated with pericarditis. Further studies with larger samples of patients and of longer duration are needed to further explore this issue.

  17. Continuing Professional Development Evaluation: Two Rapid Review Courses inNephrology and Rheumatology

    Directory of Open Access Journals (Sweden)

    Abdullah Shehab

    2012-09-01

    Full Text Available Objectives: Continuing professional development (CPD is anovel approach to increase professional knowledge and skills. The aim of this study is to explore participants’ characteristics and to understand participants’ views on two rapid review courses (RRCs as part of CPD program, and to assess healthcare providers’ views about the use of internet for accessing medical information.Methods: Data were collected from 150 participants who attended an RRC in Nephrology and Rheumatology as part of an ongoing CME program.Results: Participants’ response rate was 92% and 84.4% in Nephrology and Rheumatology RRCs, respectively. Participants’ Mean Age±SD were 39±2.1 and 41±2.1 years in the Nephrology and Rheumatology courses, respectively. Demographic variables, i.e., age, gender, and specialization showed a significant (p<0.01 impact on the learning objectives of the program. Further, participants reported that the course material had a significant (p<0.02 impacton their knowledge. Finding new medical information was the primary motive to search the internet among all participants. About half of the subjects reported knowledge of their preferred medical education sites and had access at their clinical setup. Barriers to internet use included lack of specific information, difficulty to download contents, and excessive material. Professional association websites, online journals, and CME programs were the most frequently searched sources of information. Most of the subjects reported significant (p<0.02 barriers to find medical resources on the internet and to adequately utilize the currently available medical search engines available in the healthcare system.Conclusion: A discipline specific and integrated CPD programmay have provided dual benefit such as accredited CME hours and a significant change in the participants’ knowledge. There is a need to increase Internet accessibility and capacity in the current healthcare facilities. Future CPD

  18. Patients' Perspectives on Information and Communication About Sexual and Relational Issues in Rheumatology Health Care.

    Science.gov (United States)

    Helland, Ylva; Dagfinrud, Hanne; Haugen, Mona-Iren; Kjeken, Ingvild; Zangi, Heidi

    2017-06-01

    Men and women with rheumatic diseases report a significantly negative impact on multiple areas of life, including sexuality. Research indicates that patients want to discuss sexual issues with health professionals (HPs) in rheumatology care but these issues are rarely addressed in consultations. The objective of the present study was to explore patients' experiences of communication with HPs about disease-related sexual issues, their perceptions of the relevance of these issues in rheumatology care and their preferences for how these topics should be handled. A qualitative design was used and 18 semi-structured interviews were performed, including eight women and ten men with inflammatory rheumatic joint diseases, aged 29-62 years. The interviews were recorded and transcribed verbatim. Data were analysed thematically. Four main themes were derived from the interviews: (i) relevance of sexual issues; (ii) vital conditions for communication; (iii) individual preferences in mode and timing of information and communication; and (iv) benefits of information and communication. The participants expressed that, although sexual issues are relevant, necessary conditions for good communication are largely lacking. HPs' knowledge, experience and personal skills, as well as having sufficient time were essential. HPs lack of initiating sexual topics contributed to uncertainty about whether their sexual challenges were disease related and whether it was a legitimate topic to discuss in rheumatology care. Patients wanted HPs to possess knowledge about possible disease-related challenges in sexual life and intimate relationships, and to facilitate communication about these aspects. There is a need to develop practice guidelines to enable HPs to integrate sexual issues as an aspect of healthcare delivery in a patient-friendly manner. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  19. Canadian Rheumatology Association Meeting, The Westin Ottawa, Ottawa, Ontario, Canada, February 8-11, 2017.

    Science.gov (United States)

    Silverman, Earl D

    2017-05-01

    The 72nd Annual Meeting of The Canadian Rheumatology Association (CRA) was held at The Westin Ottawa, Ottawa, Ontario, Canada, February 8-11, 2017. The program consisted of presentations covering original research, symposia, awards, and lectures. Highlights of the meeting include the following 2017 award winners: Dr. Vinod Chandran, Young Investigator; Dr. Jacques P. Brown, Distinguished Investigator; Dr. David Robinson, Teacher-Educator; Dr. Michel Zummer, Distinguished Rheumatologist; Ms. Rebecca Gole, Best Abstract on SLE Research by a Trainee - Ian Watson Award; Ms. Bailey Russell, Best Abstract on Clinical or Epidemiology Research by a Trainee - Phil Rosen Award; Dr. Sahil Koppikar and Dr. Henry Averns, Practice Reflection Award; Dr. Shirine Usmani, Best Abstract on Basic Science Research by a Trainee; Ms. Carol Dou, Best Abstract for Research by an Undergraduate Student; Dr. Dania Basodan, Best Abstract on Research by a Rheumatology Resident; Dr. Claire Barber, Best Abstract on Adult Research by Young Faculty; Ms. Audrea Chen, Best Abstract by a Medical Student; Dr. Kun Huang, Best Abstract by a Post-Graduate Resident; and Dr. Ryan Lewinson, Best Abstract by a Post-Graduate Research Trainee. Lectures and other events included a Keynote Lecture by Jonathon Fowles: Exercise is Medicine: Is Exercise a Good or Bad Thing for People with Arthritis?; State of the Art Lecture by Matthew Warman: Insights into Bone Biology and Therapeutics Gleaned from the Sustained Investigation of Rare Diseases; Dunlop-Dottridge Lecture by Allen Steere: Lyme Disease: A New Problem for Rheumatologists in Canada; and the Great Debate: Be it Resolved that the Least Expensive Treatment Should be Chosen. Switch, Switch, Switch! Arguing for: Jonathan Chan and Antonio Avina, and against: Marinka Twilt and Glen Hazlewood. Topics such as rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, Sjögren syndrome, psoriatic arthritis, spondyloarthritis, vasculitis, osteoarthritis

  20. International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; availability. Notice.

    Science.gov (United States)

    2010-01-21

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance, which is a revision of an existing guidance, discusses the types of nonclinical studies, their scope and duration, and their relation to the conduct of human clinical trials and marketing authorization for pharmaceuticals. The guidance is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources.

  1. International survey of primary and revision total knee replacement

    NARCIS (Netherlands)

    Kurtz, Steven M.; Ong, Kevin L.; Lau, Edmund; Widmer, Marcel; Maravic, Milka; Gomez-Barrena, Enrique; de Pina, Maria de Fatima; Manno, Valerio; Torre, Marina; Walter, William L.; de Steiger, Richard; Geesink, Rudolph G. T.; Peltola, Mikko; Roeder, Christoph

    2011-01-01

    Total knee arthroplasty (TKA) is currently the international standard of care for treating degenerative and rheumatologic knee joint disease, as well as certain knee joint fractures. We sought to answer the following three research questions: (1) What is the international variance in primary and

  2. Association between antinuclear antibody titers and connective tissue diseases in a Rheumatology Department.

    Science.gov (United States)

    Menor Almagro, Raúl; Rodríguez Gutiérrez, Juan Francisco; Martín-Martínez, María Auxiliadora; Rodríguez Valls, María José; Aranda Valera, Concepción; de la Iglesia Salgado, José Luís

    To determine the dilution titles at antinuclear antibodies (ANA) by indirect immunofluorescence observed in cell substrate HEp-2 and its association with the diagnosis of systemic connective tissue disease in ANA test requested by a Rheumatology Unit. Samples of patients attended for the first time in the rheumatology unit, without prior ANA test, between January 2010 and December 2012 were selected. The dilution titers, immunofluorescence patterns and antigen specificity were recorded. In January 2015 the diagnosis of the patients were evaluated and classified in systemic disease connective tissue (systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, undifferentiated connective, antiphospholipid syndrome, mixed connective tissue and inflammatory myophaty) or not systemic disease connective tissue. A total of 1282 ANA tests requested by the Rheumatology Unit in subjects without previous study, 293 were positive, predominance of women (81.9%). Patients with systemic connective tissue disease were recorded 105, and 188 without systemic connective tissue disease. For 1/640 dilutions the positive predictive value in the connective was 73.3% compared to 26.6% of non-connective, and for values ≥1/1,280 85% versus 15% respectively. When performing the multivariate analysis we observed a positive association between 1/320 dilution OR 3.069 (95% CI: 1.237-7.614; P=.016), 1/640 OR 12.570 (95% CI: 3.659-43.187; P=.000) and ≥1/1,280 OR 42.136 (95% CI: 8.604-206.345; P=.000). These results show association titles dilution ≥1/320 in ANA's first test requested by a Rheumatology Unit with patients with systemic connective tissue disease. The VPP in these patients was higher than previous studies requested by other medical specialties. This may indicate the importance of application of the test in a targeted way. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

  3. Rheumatology in the Italian literary fiction: “La Longobarda” by Giorgio Conconi (1999

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    P. Marson

    2011-09-01

    Full Text Available In the literary fiction “La Longobarda” by Giorgio Conconi (1999 the protagonist Linda narrates her life, when about fifty she falls ill because of arthritis, thus looking prematurely older and suffering from severe disturbances of body image. This fiction represents an uncommon case of contemporary literature dealing with rheumatological topics. In the present note, it has shown how literature can contribute in several ways to achievement in the human dimension of medicine, by teaching physician concrete and powerful lessons about the lives of sick people.

  4. Implications of ICD-10 for Sarcopenia Clinical Practice and Clinical Trials: Report by the International Conference on Frailty and Sarcopenia Research Task Force.

    Science.gov (United States)

    Vellas, B; Fielding, R A; Bens, C; Bernabei, R; Cawthon, P M; Cederholm, T; Cruz-Jentoft, A J; Del Signore, S; Donahue, S; Morley, J; Pahor, M; Reginster, J-Y; Rodriguez Mañas, L; Rolland, Y; Roubenoff, R; Sinclair, A; Cesari, M

    2018-01-01

    Establishment of an ICD-10-CM code for sarcopenia in 2016 was an important step towards reaching international consensus on the need for a nosological framework of age-related skeletal muscle decline. The International Conference on Frailty and Sarcopenia Research Task Force met in April 2017 to discuss the meaning, significance, and barriers to the implementation of the new code as well as strategies to accelerate development of new therapies. Analyses by the Sarcopenia Definitions and Outcomes Consortium are underway to develop quantitative definitions of sarcopenia. A consensus conference is planned to evaluate this analysis. The Task Force also discussed lessons learned from sarcopenia trials that could be applied to future trials, as well as lessons from the osteoporosis field, a clinical condition with many constructs similar to sarcopenia and for which ad hoc treatments have been developed and approved by regulatory agencies.

  5. The Right to a Fair Trial and International Cooperation in Criminal Matters: Article 6 ECHR and the Recovery of Assets in Grand Corruption Cases

    Directory of Open Access Journals (Sweden)

    Radha Dawn Ivory

    2013-09-01

    Full Text Available Are fair trial rights general principles of transnational criminal law (TCL? If so, how do they protect individuals who are affected by transnational proceedings? Posing these questions in the context of international cooperation efforts aimed at ‘asset recovery’, this contribution asks whether State Parties to the European Convention on Human Rights (ECHR are likely to violate the right to a fair trial in Article 6 ECHR when they directly enforce confiscation orders that are issued abroad with respect to the proceeds, objects or instrumentalities of high-value, high-level political corruption offences or substitute assets. The European Court of Human Rights (ECtHR considers that ECHR State Parties might exceptionally violate Article 6 ECHR in cooperative cases if the alleged victim ‘has suffered or risks suffering a flagrant denial of a fair trial in the requesting country’. Surveying its case law, I argue that the ‘flagrant denial of justice’ standard greatly attenuates the right to a fair trial in cases of international cooperation in criminal matters. In practice, the Court appears unwilling to find violations of Article 6 ECHR in such cases when the foreign proceedings do not involve allegations of treatment contrary to Articles 2 or 3 ECHR. This, it is submitted, reflects the difficulty of assessing ‘fairness’ in globalised law enforcement situations, a factor that also complicates efforts to deduce a general principle of a right to a fair trial from ‘justice’ as an objective of TCL. If those principles are formulated inductively and comparatively, the ECtHR’s case law nevertheless goes some way towards showing that a weak transnational fair trial right may be a general principle of TCL within the ‘legal space’ of the ECHR.

  6. The role of the State Security Service (Stasi) in the context of international clinical trials conducted by western pharmaceutical companies in Eastern Germany (1961-1990).

    Science.gov (United States)

    Erices, Rainer; Frewer, Andreas; Gumz, Antje

    2018-01-01

    After the building of the Berlin Wall in the 1960s, a number of international pharmaceutical manufacturers from the West had their drugs tested in Eastern Germany (GDR). So far, the extensive collection of documents on the subject stored in the archives of the GDR State Security Service (Stasi, MfS) has not been systematically analysed. Until now, the role of the Stasi with respect to the surveillance of the trials has been unclear. A keyword search within the database of the Stasi files was conducted. All available files were screened in order to identify institutions, companies and personnel involved in the clinical trials. On this basis, further files were requested. A total of 259 files were available for analysis. Relevant data was derived from 160 of these files. A contextualised approach was applied, which critically explored the origin, content, and impact of the data. In addition, an approach guided by the central steps of document analysis was applied. At least 400 clinical trials were conducted during the GDR period. The exact number remains speculative. According to references found in the Stasi files, it might have been considerably higher. Initially, the main goal of the trials was for the GDR authorities to decide whether to import certain Western drugs. By 1983, this intention had changed. Now, the primary aim of the trials was the procurement of foreign currency. The Stasi feared that the pharmaceutical companies could have a significant influence on GDR Health System. Stasi spies were holding positions in the responsible medical committees, universities, and hospitals. Constant surveillance by the Stasi served the purpose of monitoring any contact between people from the West and the East. Unknowingly, representatives of Western companies were surveilled by the Stasi. The studied documents also point to the fact that a number of clinical trials conducted during the GDR period did not comply with GDR regulations, and were therefore deemed illegal

  7. Cerebral White Matter Hypoperfusion Increases with Small-Vessel Disease Burden. Data From the Third International Stroke Trial.

    Science.gov (United States)

    Arba, Francesco; Mair, Grant; Carpenter, Trevor; Sakka, Eleni; Sandercock, Peter A G; Lindley, Richard I; Inzitari, Domenico; Wardlaw, Joanna M

    2017-07-01

    Leukoaraiosis is associated with impaired cerebral perfusion, but the effect of individual and combined small-vessel disease (SVD) features on white matter perfusion is unclear. We studied patients recruited with perfusion imaging in the Third International Stroke Trial. We rated individual SVD features (leukoaraiosis, lacunes) and brain atrophy on baseline plain computed tomography or magnetic resonance imaging. Separately, we assessed white matter at the level of the lateral ventricles in the cerebral hemisphere contralateral to the stroke for visible areas of hypoperfusion (present or absent) on 4 time-based perfusion imaging parameters. We examined associations between SVD features (individually and summed) and presence of hypoperfusion using logistic regression adjusted for age, sex, baseline National Institutes of Health Stroke Scale, hypertension, and diabetes. A total of 115 patients with median (interquartile range) age of 81 (72-86) years, 78 (52%) of which were male, had complete perfusion data. Hypoperfusion was most frequent on mean transit time (MTT; 63 patients, 55%) and least frequent on time to maximum flow (19 patients, 17%). The SVD score showed stronger independent associations with hypoperfusion (e.g., MTT, odds ratio [OR] = 2.80; 95% confidence interval [CI] = 1.56-5.03) than individual SVD markers (e.g., white matter hypoattenuation score, MTT, OR = 1.49, 95% CI = 1.09-2.04). Baseline blood pressure did not differ by presence or absence of hypoperfusion or across strata of SVD score. Presence of white matter hypoperfusion increased with SVD summed score. The SVD summed score was associated with hypoperfusion more consistently than individual SVD features, providing validity to the SVD score concept. Increasing SVD burden indicates worse perfusion in the white matter. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  8. Observer reliability of CT angiography in the assessment of acute ischaemic stroke: data from the Third International Stroke Trial

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    Mair, Grant; Farrall, Andrew J.; Sellar, Robin J.; Mollison, Daisy; Sakka, Eleni; Palmer, Jeb; Wardlaw, Joanna M. [University of Edinburgh, Western General Hospital, Division of Neuroimaging Sciences, Edinburgh (United Kingdom); Kummer, Ruediger von [Dresden University Stroke Centre, University Hospital, Department of Neuroradiology, Dresden (Germany); Adami, Alessandro [Sacro Cuore-Don Calabria Hospital, Stroke Center, Department of Neurology, Negrar (Italy); White, Philip M. [Stroke Research Group, Newcastle upon Tyne (United Kingdom); Adams, Matthew E. [National Hospital for Neurology and Neurosurgery, Department of Neuroradiology, London (United Kingdom); Yan, Bernard [Royal Melbourne Hospital, Neurovascular Research Group, Parkville (Australia); Demchuk, Andrew M. [Calgary Stroke Program, Department of Clinical Neurosciences, Calgary (Canada); Ramaswamy, Rajesh; Rodrigues, Mark A.; Samji, Karim; Baird, Andrew J. [Royal Infirmary of Edinburgh, Department of Radiology, Edinburgh (United Kingdom); Boyd, Elena V. [Northwick Park Hospital, Department of Radiology, Harrow (United Kingdom); Cohen, Geoff; Perry, David; Sandercock, Peter A.G. [University of Edinburgh, Western General Hospital, Division of Clinical Neurosciences, Edinburgh (United Kingdom); Lindley, Richard [University of Sydney, Westmead Hospital Clinical School and The George Institute for Global Health, Sydney (Australia); Collaboration: The IST-3 Collaborative Group

    2014-10-07

    CT angiography (CTA) is often used for assessing patients with acute ischaemic stroke. Only limited observer reliability data exist. We tested inter- and intra-observer reliability for the assessment of CTA in acute ischaemic stroke. We selected 15 cases from the Third International Stroke Trial (IST-3, ISRCTN25765518) with various degrees of arterial obstruction in different intracranial locations on CTA. To assess inter-observer reliability, seven members of the IST-3 expert image reading panel (>5 years experience reading CTA) and seven radiology trainees (<2 years experience) rated all 15 scans independently and blind to clinical data for: presence (versus absence) of any intracranial arterial abnormality (stenosis or occlusion), severity of arterial abnormality using relevant scales (IST-3 angiography score, Thrombolysis in Cerebral Infarction (TICI) score, Clot Burden Score), collateral supply and visibility of a perfusion defect on CTA source images (CTA-SI). Intra-observer reliability was assessed using independently repeated expert panel scan ratings. We assessed observer agreement with Krippendorff's-alpha (K-alpha). Among experienced observers, inter-observer agreement was substantial for the identification of any angiographic abnormality (K-alpha = 0.70) and with an angiography assessment scale (K-alpha = 0.60-0.66). There was less agreement for grades of collateral supply (K-alpha = 0.56) or for identification of a perfusion defect on CTA-SI (K-alpha = 0.32). Radiology trainees performed as well as expert readers when additional training was undertaken (neuroradiology specialist trainees). Intra-observer agreement among experts provided similar results (K-alpha = 0.33-0.72). For most imaging characteristics assessed, CTA has moderate to substantial observer agreement in acute ischaemic stroke. Experienced readers and those with specialist training perform best. (orig.)

  9. Observer reliability of CT angiography in the assessment of acute ischaemic stroke: data from the Third International Stroke Trial

    International Nuclear Information System (INIS)

    Mair, Grant; Farrall, Andrew J.; Sellar, Robin J.; Mollison, Daisy; Sakka, Eleni; Palmer, Jeb; Wardlaw, Joanna M.; Kummer, Ruediger von; Adami, Alessandro; White, Philip M.; Adams, Matthew E.; Yan, Bernard; Demchuk, Andrew M.; Ramaswamy, Rajesh; Rodrigues, Mark A.; Samji, Karim; Baird, Andrew J.; Boyd, Elena V.; Cohen, Geoff; Perry, David; Sandercock, Peter A.G.; Lindley, Richard

    2015-01-01

    CT angiography (CTA) is often used for assessing patients with acute ischaemic stroke. Only limited observer reliability data exist. We tested inter- and intra-observer reliability for the assessment of CTA in acute ischaemic stroke. We selected 15 cases from the Third International Stroke Trial (IST-3, ISRCTN25765518) with various degrees of arterial obstruction in different intracranial locations on CTA. To assess inter-observer reliability, seven members of the IST-3 expert image reading panel (>5 years experience reading CTA) and seven radiology trainees (<2 years experience) rated all 15 scans independently and blind to clinical data for: presence (versus absence) of any intracranial arterial abnormality (stenosis or occlusion), severity of arterial abnormality using relevant scales (IST-3 angiography score, Thrombolysis in Cerebral Infarction (TICI) score, Clot Burden Score), collateral supply and visibility of a perfusion defect on CTA source images (CTA-SI). Intra-observer reliability was assessed using independently repeated expert panel scan ratings. We assessed observer agreement with Krippendorff's-alpha (K-alpha). Among experienced observers, inter-observer agreement was substantial for the identification of any angiographic abnormality (K-alpha = 0.70) and with an angiography assessment scale (K-alpha = 0.60-0.66). There was less agreement for grades of collateral supply (K-alpha = 0.56) or for identification of a perfusion defect on CTA-SI (K-alpha = 0.32). Radiology trainees performed as well as expert readers when additional training was undertaken (neuroradiology specialist trainees). Intra-observer agreement among experts provided similar results (K-alpha = 0.33-0.72). For most imaging characteristics assessed, CTA has moderate to substantial observer agreement in acute ischaemic stroke. Experienced readers and those with specialist training perform best. (orig.)

  10. Patient's Knowledge and Perception Towards the use of Non-steroidal Anti-Inflammatory Drugs in Rheumatology Clinic Northern Malaysia.

    Science.gov (United States)

    Sulaiman, Wahinuddin; Seung, Ong Ping; Ismail, Rosli

    2012-11-01

    In Rheumatology, non-steroidal anti-inflammatory drugs (NSAIDs) has been widely prescribed and used. However, despite their clinical benefits in the management of inflammatory and degenerative joint disease, NSAIDs have considerable side effects, mostly affecting the upper gastrointestinal system, which therefore, limit their use. This study was conducted to determine the patients' knowledge and perception regarding the used of NSAIDS. A total of 120 patients who attended the rheumatology clinic Hospital, Raja Permaisuri Bainun, Malaysia, and received NSAIDs more than 3 months were interviewed irrespective of their rheumatological conditions. Patient's knowledge and perception on the side effects of NSAIDs were recorded. Fifty-four percent of the patients obtained information regarding the side effect of NSAIDs either from the rheumatologist, rheumatology staff nurse or other medical staffs (75.4%). The remaining 45.8% were naive of such knowledge. Fifteen percent obtained the information by surfing the internet and 9.2% from printed media. Twenty-four (24.2%) patients, experienced indigestion and/or stomach discomfort attributed to NSAIDs used. Two patients (1.7%) had hematemesis and malena once. This study shows that half of the patients who attended the rheumatology clinic were unaware of the side effect of NSAIDs. Available data showed that most of the knowledgeable patients are more conscience and self-educated. This study also reveals the important roles of clinicians, trained staff nurses as well as the pharmacist in providing the guidance and knowledge of any medication taken by patients.

  11. Clinical, manometric, and ultrasonographic results of pneumatic balloon dilatation vs. lateral internal sphincterotomy for chronic anal fissure: a prospective, randomized, controlled trial.

    Science.gov (United States)

    Renzi, Adolfo; Izzo, Domenico; Di Sarno, Giandomenico; Talento, Pasquale; Torelli, Francesco; Izzo, Giuseppe; Di Martino, Natale

    2008-01-01

    This prospective, randomized, controlled trial was designed to compare the clinical, functional, and morphologic results of pneumatic balloon dilatation with lateral internal sphincterotomy for the treatment of chronic anal fissure. All patients with symptomatic chronic anal fissure were randomly assigned to pneumatic balloon dilatation or lateral internal sphincterotomy and invited to complete a standardized questionnaire inquiring about their symptoms. Anal ultrasonography and anal manometry were performed before and six months after surgery. A proctologic examination was performed between the fifth and sixth postoperative weeks. Anal continence, scored by using a validated continence grading scale, was evaluated preoperatively at 1 and 6 weeks and at 12 and 24 months. Fifty-three patients, who satisfied selection criteria, were enrolled in the trial. Four patients (7.5 percent) were lost to follow-up. Twenty-four patients (11 males; mean age, 42 +/- 8.2 years) underwent pneumatic balloon dilatation and 25 patients (10 males; mean age, 44 +/- 7.3 years) underwent lateral internal sphincterotomy. Fissure-healing rates were 83.3 percent in the pneumatic balloon dilatation and 92 percent in the lateral internal sphincterotomy group. Recurrent anal fissure was observed in one patient (4 percent) after lateral internal sphincterotomy. At anal manometry, mean resting pressure decrements obtained after pneumatic balloon dilatation and lateral internal sphincterotomy were 30.5 and 34.3 percent, respectively. After pneumatic balloon dilatation, anal ultrasonography did not show any significant sphincter damage. At 24-month follow-up, the incidence of incontinence, irrespective of severity, was 0 percent in the pneumatic balloon dilatation group and 16 percent in the lateral internal sphincterotomy group (P < 0.0001). As lateral internal sphincterotomy, pneumatic balloon dilatation grants a high anal fissure-healing rate but with a statistically significant reduction in

  12. The validity and internal structure of the Bipolar Depression Rating Scale: data from a clinical trial of N-acetylcysteine as adjunctive therapy in bipolar disorder.

    Science.gov (United States)

    Berk, Michael; Dodd, Seetal; Dean, Olivia M; Kohlmann, Kristy; Berk, Lesley; Malhi, Gin S

    2010-10-01

    Berk M, Dodd S, Dean OM, Kohlmann K, Berk L, Malhi GS. The validity and internal structure of the Bipolar Depression Rating Scale: data from a clinical trial of N-acetylcysteine as adjunctive therapy in bipolar disorder. The phenomenology of unipolar and bipolar disorders differ in a number of ways, such as the presence of mixed states and atypical features. Conventional depression rating instruments are designed to capture the characteristics of unipolar depression and have limitations in capturing the breadth of bipolar disorder. The Bipolar Depression Rating Scale (BDRS) was administered together with the Montgomery Asberg Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) in a double-blind randomised placebo-controlled clinical trial of N-acetyl cysteine for bipolar disorder (N = 75). A factor analysis showed a two-factor solution: depression and mixed symptom clusters. The BDRS has strong internal consistency (Cronbach's alpha = 0.917), the depression cluster showed robust correlation with the MADRS (r = 0.865) and the mixed subscale correlated with the YMRS (r = 0.750). The BDRS has good internal validity and inter-rater reliability and is sensitive to change in the context of a clinical trial.

  13. Use of an android phone application for automated text messages in international settings: A case study in an HIV clinical trial in St. Petersburg, Russia.

    Science.gov (United States)

    Forman, Leah S; Patts, Gregory J; Coleman, Sharon M; Blokhina, Elena; Lu, John; Yaroslavtseva, Tatiana; Gnatienko, Natalia; Krupitsky, Evgeny; Samet, Jeffrey H; Chaisson, Christine E

    2018-02-01

    Reproducible outcomes in clinical trials depend on adherence to study protocol. Short message service (also known as text message) reminders have been shown to improve clinical trial adherence in the United States and elsewhere. However, due to systematic differences in mobile data plans, languages, and technology, these systems are not easily translated to international settings. To gauge technical capabilities for international projects, we developed SMSMessenger, an automated Android application that uses a US server to send medication reminders to participants in a clinical trial in St. Petersburg, Russia (Zinc for HIV disease among alcohol users-a randomized controlled trial in the Russia Alcohol Research Collaboration on HIV/AIDS cohort). The application is downloaded once onto an Android study phone. When it is time for the text message reminders to be sent, study personnel access the application on a local phone, which in turn accesses the existing clinical trial database hosted on a US web server. The application retrieves a list of participants with the following information: phone number, whether a message should be received at that time, and the appropriate text of the message. The application is capable of storing multiple outgoing messages. With a few clicks, text messages are sent to study participants who can reply directly to the message. Study staff can check the local phone for incoming messages. The SMSMessenger application uses an existing clinical trial database and is able to receive real-time updates. All communications between the application and server are encrypted, and phone numbers are stored in a secure database behind a firewall. No sensitive data are stored on the phone, as outgoing messages are sent through the application and not by messaging features on the phone itself. Messages are sent simultaneously to study participants, which reduces the burden on local study staff. Costs and setup are minimal. The only local requirements

  14. Update on the third international stroke trial (IST-3 of thrombolysis for acute ischaemic stroke and baseline features of the 3035 patients recruited

    Directory of Open Access Journals (Sweden)

    Sandercock Peter

    2011-11-01

    Full Text Available Abstract Background Intravenous recombinant tissue plasminogen activator (rtPA is approved in Europe for use in patients with acute ischaemic stroke who meet strictly defined criteria. IST-3 sought to improve the external validity and precision of the estimates of the overall treatment effects (efficacy and safety of rtPA in acute ischaemic stroke, and to determine whether a wider range of patients might benefit. Design International, multi-centre, prospective, randomized, open, blinded endpoint (PROBE trial of intravenous rtPA in acute ischaemic stroke. Suitable patients had to be assessed and able to start treatment within 6 hours of developing symptoms, and brain imaging must have excluded intracranial haemorrhage and stroke mimics. Results The initial pilot phase was double blind and then, on 01/08/2003, changed to an open design. Recruitment began on 05/05/2000 and closed on 31/07/2011, by which time 3035 patients had been included, only 61 (2% of whom met the criteria for the 2003 European approval for thrombolysis. 1617 patients were aged over 80 years at trial entry. The analysis plan will be finalised, without reference to the unblinded data, and published before the trial data are unblinded in early 2012. The main trial results will be presented at the European Stroke Conference in Lisbon in May 2012 with the aim to publish simultaneously in a peer-reviewed journal. The trial result will be presented in the context of an updated Cochrane systematic review. We also intend to include the trial data in an individual patient data meta-analysis of all the relevant randomised trials. Conclusion The data from the trial will: improve the external validity and precision of the estimates of the overall treatment effects (efficacy and safety of iv rtPA in acute ischaemic stroke; provide: new evidence on the balance of risk and benefit of intravenous rtPA among types of patients who do not clearly meet the terms of the current EU approval; and

  15. Increased occurrence of cardiovascular events and comorbidities in a general rheumatology cohort.

    LENUS (Irish Health Repository)

    Mohammad, A

    2012-02-01

    BACKGROUND: To identify cardiovascular and other comorbidities in a general rheumatology cohort. METHODS: Interviews\\/retrospective chart audits were conducted on 1,000 patients attending rheumatology outpatient clinics of a university teaching hospital. Comorbidities were classified using the Charlson comorbidity index (Ambrose et al. in Ir J Med Sci 178(1):53-55, 2009). RESULTS: Mean age 58 +\\/- 15.3 years, mean BMI 26. Of the patients, 400 (40%) were diagnosed with dyslipidemia and hypertension (p = 0.002), 160 (16%) with obesity and 80 (8%) with hypothyroidism. Overall 160 (16%) patients were diagnosed with coronary heart disease (CHD). Of these, 120 (75%) had RA (p = 0.001), 100 (63%) were male, mean age 60 +\\/- 15.8 years, 120 (75%) had dyslipidemia and BMI > 30 (p = 0.002), 112 (70%) were smokers (p = 0.002), 40 (25%) were diagnosed with diabetes mellitus and 20 (12%) with hypothyroidism. CONCLUSIONS: The increased prevalence of these comorbidities may serve as a reminder to the rheumatologists that many of their patients will have coexistent disease of which they need to be aware to properly plan their management.

  16. Infections in an inpatient rheumatology unit: how big is the problem?

    Directory of Open Access Journals (Sweden)

    Romana Vieira

    2016-10-01

    Full Text Available Patients with rheumatic diseases are at high risk of infections. As quantification and characterization of infections in daily practice is a crucial exercise to delineate strategies to overcome this problem, we aimed to describe the prevalence of infections in an inpatient rheumatology unit. A cross-sectional analysis of all patients admitted at the São João Hospital Centre Rheumatology Unit between January 1st 2012 and December 31st 2013 was performed. We found a 31.7% (n=79 period prevalence of infection and a total number of infections of 97 (1.23 infections per patient. They were the admission reason in 17.6% (n=44 and hospital acquired in 19.0% (n=15 of the cases. The urinary tract was the most commonly affected (32.0%; n=31 and Escherichia coli (17.5%; n=17 the most frequently identified infectious agent. Infection prolonged the hospital length of stay in 34.2% (n=27 of the cases but any death occurred as a direct consequence of it. Patients with infection were older, had longer rheumatic disease duration and longer hospital length of stay than those without infection. We conclude that the prevalence of infection in our inpatient population is high but most cases were non complicated, easily treated with common antibiotics and, importantly, not associated with higher lethality.

  17. Lifestyle and dietary habits of patients with gout followed in rheumatology settings.

    Science.gov (United States)

    Manara, M; Carrara, G; Scirè, C A; Cimmino, M A; Govoni, M; Montecucco, C; Matucci-Cerinic, M; Minisola, G; Study Group, The King

    2015-12-23

    Diet and lifestyles modification are core aspects of the non-pharmacological management of gout, but a poor consistency with suggested guidelines is reported. This study aimed to investigate dietary and lifestyle habits of patients with gout followed in rheumatology settings. Data were retrieved from the baseline dataset of the KING study, a multicentre cohort study of patients with gout followed in rheumatology settings. Dietary habits were assessed with the Italian National Institute of Statistics (ISTAT) food-frequency questionnaire and compared with reported data about general population. The relative increase of exposure was estimated by standardized prevalence ratios adjusted for gender, age and geographical distribution. The study population included 446 patients, with a mean age of 63.9 years and a M/F ratio of 9:1. Compared to the Italian population, gouty patients showed a higher prevalence of obesity [1.82 (1.52-2.18)] and a higher consumption of wine [1.85 (1.48-2.32)] and beer [2.21 (1.68-2.90)], but a lower prevalence of smoking and a lower intake of liquor. They showed a lower intake of red meat [0.80 (0.71-0.91)], but a similar intake of other tested dietary factors. Gouty patients' lifestyle is still partially different from the recommended.

  18. Survey of herbal cannabis (marijuana) use in rheumatology clinic attenders with a rheumatologist confirmed diagnosis.

    Science.gov (United States)

    Ste-Marie, Peter A; Shir, Yoram; Rampakakis, Emmanouil; Sampalis, John S; Karellis, Angela; Cohen, Martin; Starr, Michael; Ware, Mark A; Fitzcharles, Mary-Ann

    2016-12-01

    Cannabinoids may hold potential for the management of rheumatic pain. Arthritis, often self-reported, is commonly cited as the reason for the use of medicinal herbal cannabis (marijuana). We have examined the prevalence of marijuana use among 1000 consecutive rheumatology patients with a rheumatologist-confirmed diagnosis and compared in an exploratory manner the clinical characteristics of medicinal users and nonusers. Current marijuana use, medicinal or recreational, was reported by 38 patients (3.8%; 95% CI: 2.8-5.2). Ever use of marijuana for medical purposes was reported by 4.3% (95% CI: 3.2-5.7), with 28 (2.8%; 95% CI: 1.9-4.0) reporting current medicinal use. Current medicinal users had a spectrum of rheumatic conditions, with over half diagnosed with osteoarthritis. Medicinal users were younger, more likely unemployed or disabled, and reported poorer global health. Pain report and opioid use was greater for users, but they had similar physician global assessment of disease status compared with nonusers. Medicinal users were more likely previous recreational users, with approximately 40% reporting concurrent recreational use. Therefore, less than 3% of rheumatology patients reported current use of medicinal marijuana. This low rate of use in patients with a rheumatologist-confirmed diagnosis is in stark contrast to the high rates of severe arthritis frequently reported by medicinal marijuana users, especially in Canada. Familiarity with marijuana as a recreational product may explain use for some as disease status was similar for both groups.

  19. Patient involvement in rheumatology outpatient service design and delivery: a case study.

    Science.gov (United States)

    de Souza, Savia; Galloway, James; Simpson, Carol; Chura, Radka; Dobson, Joanne; Gullick, Nicola J; Steer, Sophia; Lempp, Heidi

    2017-06-01

    Patient involvement is increasingly recognized as important within the UK National Health Service to ensure that services delivered are relevant to users' needs. Organizations are encouraged to work with service users to achieve excellence in care. Patient education can improve health outcomes and reduce health-care costs. Mobile technologies could play a vital role in this. Patient-centred development of innovative strategies to improve the experience of rheumatology outpatients. The Group Rheumatology Initiative Involving Patients (GRIIP) project was set up in 2013 as a joint venture between patients, clinicians, academics and management at a London hospital. The project saw (i) the formation of an independent patient group which provided suggestions for service improvement - outcomes included clearer signs in the outpatient waiting area, extended phlebotomy opening hours and better access to podiatry; (ii) a rolling patient educational evening programme initiated in 2014 with topics chosen by patient experts - feedback has been positive and attendance continues to grow; and (iii) a mobile application (app) co-designed with patients launched in 2015 which provides relevant information for outpatient clinic attendees and data capture for clinicians - downloads have steadily increased as users adopt this new technology. Patients can effectively contribute to service improvement provided they are supported, respected as equals, and the organization is willing to undergo a cultural change. © 2016 The Authors. Health Expectations Published by John Wiley & Sons Ltd.

  20. Analysis of information on rheumatology from a selected Internet forum in the context of the need for telemedicine solutions

    Directory of Open Access Journals (Sweden)

    Rafał Szpakowski

    2015-12-01

    Full Text Available Objectives: The aim of this study was to determine how often patients and undiagnosed people who complain of musculoskeletal system and rheumatic diseases look for knowledge contained on an Internet forum. Content analysis was used to identify the level of Internet users’ activity in the rheumatology section, compared to other areas of medicine. Material and methods : Material included information posted on the Internet forum established at http://medyczka.pl/. The method employed was a quantitative and qualitative analysis of the content. The method was based on qualitative assessment of the first post in each thread presented on the rheumatologic subforum, by assigning keywords, subjectively determined by the researcher, to such a post. For each keyword a specific definition was established, determining a situation in which a given keyword was used. Results: The quantitative analysis qualified rheumatology in the last place in terms of Internet users’ activity compared to other branches of medicine. The qualitative assessment of the rheumatologic forum indicated that the three most common keywords were joint pain (32, joints swelling (13, and schoolage (13. The three most common intentional keywords (arranged in order of their decreasing number were diagnosis based on symptoms (29, interpretation of the laboratory test results (9, and how to deal with symptoms (8. Conclusions : The analysis leads to the conclusion that the rheumatologic subforum, along with other subforums listed above, presents a critically low level of discussion. There is a large disproportion between the number of active and passive forum users, suggesting that numerous individuals search the forum for presented information. Based on the qualitative analysis of the information stocks of the rheumatologic subforum, it was established that most of the questions posted concerned young individuals, who complained of joint pain and swelling, and asked for a possible

  1. Rheumatology education for undergraduate nursing, physiotherapy and occupational therapy students in the UK: standards, challenges and solutions.

    Science.gov (United States)

    Hewlett, S; Clarke, B; O'Brien, A; Hammond, A; Ryan, S; Kay, L; Richards, P; Almeida, C

    2008-07-01

    Rheumatological conditions are common, thus nurses (Ns) occupational therapists (OTs) and physiotherapists (PTs) require at least basic rheumatology knowledge upon qualifying. The aim of this study was to develop a core set of teaching topics and potential ways of delivering them. A modified Delphi technique was used for clinicians to develop preliminary core sets of teaching topics for each profession. Telephone interviews with educationalists explored their views on these, and challenges and solutions for delivering them. Inter-professional workshops enabled clinicians and educationalists to finalize the core set together, and generate methods for delivery. Thirty-nine rheumatology clinicians (12N, 14OT, 13PT) completed the Delphi consensus, proposing three preliminary core sets (N71 items, OT29, PT26). Nineteen educationalists (6N, 7OT, 6PT) participated in telephone interviews, raising concerns about disease-specific vs generic teaching and proposing many methods for delivery. Three inter-professional workshops involved 34 participants (clinicians: N12, OT9, PT5; educationalists: N2, OT3, PT2; Patient 1) who reached consensus on a single core set comprising six teaching units: Anatomy and Physiology; Assessment; Management and Intervention; Psychosocial Issues; Patient Education; and the Multi-disciplinary Team, recommending some topics within the units receive greater depth for some professions. An innovative range of delivery options was generated plus two brief interventions: a Rheumatology Chat Show and a Rheumatology Road Show. Working together, clinicians and educationalists proposed a realistic core set of rheumatology topics for undergraduate health professionals. They proposed innovative delivery methods, with collaboration between educationalists, clinicians and patients strongly recommended. These potential interventions need testing.

  2. Analysis of information on rheumatology from a selected Internet forum in the context of the need for telemedicine solutions.

    Science.gov (United States)

    Szpakowski, Rafał; Maślińska, Maria; Dykowska, Grażyna; Zając, Patrycja

    2015-01-01

    The aim of this study was to determine how often patients and undiagnosed people who complain of musculoskeletal system and rheumatic diseases look for knowledge contained on an Internet forum. Content analysis was used to identify the level of Internet users' activity in the rheumatology section, compared to other areas of medicine. Material included information posted on the Internet forum established at http://medyczka.pl/. The method employed was a quantitative and qualitative analysis of the content. The method was based on qualitative assessment of the first post in each thread presented on the rheumatologic subforum, by assigning keywords, subjectively determined by the researcher, to such a post. For each keyword a specific definition was established, determining a situation in which a given keyword was used. The quantitative analysis qualified rheumatology in the last place in terms of Internet users' activity compared to other branches of medicine. The qualitative assessment of the rheumatologic forum indicated that the three most common keywords were joint pain (32), joints swelling (13), and schoolage (13). The three most common intentional keywords (arranged in order of their decreasing number) were diagnosis based on symptoms (29), interpretation of the laboratory test results (9), and how to deal with symptoms (8). The analysis leads to the conclusion that the rheumatologic subforum, along with other subforums listed above, presents a critically low level of discussion. There is a large disproportion between the number of active and passive forum users, suggesting that numerous individuals search the forum for presented information. Based on the qualitative analysis of the information stocks of the rheumatologic subforum, it was established that most of the questions posted concerned young individuals, who complained of joint pain and swelling, and asked for a possible diagnosis based on the presented symptomatology, interpretation of the laboratory

  3. International multicentre randomised controlled trial of improvisational music therapy for children with autism spectrum disorder: TIME-A study.

    Science.gov (United States)

    Crawford, Mike J; Gold, Christian; Odell-Miller, Helen; Thana, Lavanya; Faber, Sarah; Assmus, Jörg; Bieleninik, Łucja; Geretsegger, Monika; Grant, Claire; Maratos, Anna; Sandford, Stephan; Claringbold, Amy; McConachie, Helen; Maskey, Morag; Mössler, Karin Antonia; Ramchandani, Paul; Hassiotis, Angela

    2017-10-01

    Preliminary studies have indicated that music therapy may benefit children with autism spectrum disorders (ASD). To examine the effects of improvisational music therapy (IMT) on social affect and responsiveness of children with ASD. International, multicentre, three-arm, single-masked randomised controlled trial, including a National Institute for Health Research (NIHR)-funded centre that recruited in London and the east of England. Randomisation was via a remote service using permuted blocks, stratified by study site. Schools and private, voluntary and state-funded health-care services. Children aged between 4 and 7 years with a confirmed diagnosis of ASD and a parent or guardian who provided written informed consent. We excluded children with serious sensory disorder and those who had received music therapy within the past 12 months. All parents and children received enhanced standard care (ESC), which involved three 60-minute sessions of advice and support in addition to treatment as usual. In addition, they were randomised to either one (low-frequency) or three (high-frequency) sessions of IMT per week, or to ESC alone, over 5 months in a ratio of 1 : 1 : 2. The primary outcome was measured using the social affect score derived from the Autism Diagnostic Observation Schedule (ADOS) at 5 months: higher scores indicated greater impairment. Secondary outcomes included social affect at 12 months and parent-rated social responsiveness at 5 and 12 months (higher scores indicated greater impairment). A total of 364 participants were randomised between 2011 and 2015. A total of 182 children were allocated to IMT (90 to high-frequency sessions and 92 to low-frequency sessions), and 182 were allocated to ESC alone. A total of 314 (86.3%) of the total sample were followed up at 5 months [165 (90.7%) in the intervention group and 149 (81.9%) in the control group]. Among those randomised to IMT, 171 (94.0%) received it. From baseline to 5 months, mean scores of ADOS

  4. Evaluation and treatment of low and anxious mood in Chinese-speaking international students studying in Scotland: study protocol of a pilot randomised controlled trial.

    Science.gov (United States)

    Zheng, Mengyi; McClay, Carrie-Anne; Wilson, Sarah; Williams, Christopher

    2015-01-01

    Low mood is a common mental health problem affecting up to 121 million people worldwide and is common in students, particularly international students. Cognitive behavioural therapy (CBT) is known to be effective as a treatment for low mood and anxiety when delivered one to one by an expert practitioner, however this can be expensive and many services have waiting lists and delayed access. A range of additional ways of increasing access to services includes the offer of online courses such as computerised CBT as a possible additional pathway for care. This project aims to test the feasibility of a pilot randomised controlled trial of an online CBT-based life skills course with Chinese-speaking international students experiencing low mood and anxiety. Chinese-speaking international students with symptoms of low mood and/or anxiety will be recruited from the University of Glasgow, Scotland. Participants will be remotely randomised to receive either immediate access (IA) or delayed access (DA) to a guided/supported online CBT-based life skills package, the "Living Life" package (Chinese version). Participants will be randomly assigned to IA or DA to the intervention. The primary end point will be at 3 months when the delayed group will be offered the intervention. Levels of depression, anxiety, social functioning and satisfaction will be assessed. This pilot study will test the trial design, ability to recruit, gather completed questionnaires, test drop-out rates and investigate completion and acceptability of the package. The study aims to reduce uncertainties about the delivery of a future substantive study and will also inform a sample size calculation for that subsequent substantive randomised controlled trial (RCT) which will be carried out to determine the effectiveness of the online package in improving low mood and anxiety in the Chinese-speaking student population. Current Controlled Trials ISRCTN30816908.

  5. Clinical Nononcologic Applications of PET/CT and PET/MRI in Musculoskeletal, Orthopedic, and Rheumatologic Imaging.

    Science.gov (United States)

    Gholamrezanezhad, Ali; Basques, Kyle; Batouli, Ali; Matcuk, George; Alavi, Abass; Jadvar, Hossein

    2018-06-01

    With improvements in PET/CT and PET/MRI over the last decade, as well as increased understanding of the pathophysiology of musculoskeletal diseases, there is an emerging potential for PET as a primary or complementary modality in the management of rheumatologic and orthopedic conditions. We discuss the role of PET/CT and PET/MRI in nononcologic musculoskeletal disorders, including inflammatory and infectious conditions and postoperative complications. There is great potential for an increased role for PET to serve as a primary or complementary modality in the management of orthopedic and rheumatologic disorders.

  6. International consensus for a definition of disease flare in lupus.

    Science.gov (United States)

    Ruperto, N; Hanrahan, L M; Alarcón, G S; Belmont, H M; Brey, R L; Brunetta, P; Buyon, J P; Costner, M I; Cronin, M E; Dooley, M A; Filocamo, G; Fiorentino, D; Fortin, P R; Franks, A G; Gilkeson, G; Ginzler, E; Gordon, C; Grossman, J; Hahn, B; Isenberg, D A; Kalunian, K C; Petri, M; Sammaritano, L; Sánchez-Guerrero, J; Sontheimer, R D; Strand, V; Urowitz, M; von Feldt, J M; Werth, V P; Merrill, J T

    2011-04-01

    The Lupus Foundation of America (LFA) convened an international working group to obtain a consensus definition of disease flare in lupus. With help from the Paediatric Rheumatology International Trials Organization (PRINTO), two web-based Delphi surveys of physicians were conducted. Subsequently, the LFA held a second consensus conference followed by a third Delphi survey to reach a community-wide agreement for flare definition. Sixty-nine of the 120 (57.5%) polled physicians responded to the first survey. Fifty-nine of the responses were available to draft 12 preliminary statements, which were circulated in the second survey. Eighty-seven of 118 (74%) physicians completed the second survey, with an agreement of 70% for 9/12 (75%) statements. During the second conference, three alternative flare definitions were consolidated and sent back to the international community. One hundred and sixteen of 146 (79.5%) responded, with agreement by 71/116 (61%) for the following definition: "A flare is a measurable increase in disease activity in one or more organ systems involving new or worse clinical signs and symptoms and/or laboratory measurements. It must be considered clinically significant by the assessor and usually there would be at least consideration of a change or an increase in treatment." The LFA proposes this definition for lupus flare on the basis of its high face validity.

  7. RETHINKING THE ROLE OF CLINICAL TRIAL DATA IN INTERNATIONAL INTELLECTUAL PROPERTY LAW: THE CASE FOR A PUBLIC GOODS APPROACH

    OpenAIRE

    REICHMAN, JEROME H.

    2009-01-01

    This article describes the growth and consequences of new intellectual property rights given to pharmaceutical developers, and it advocates treating clinical trials as a public good. Although the soaring cost of clinical trials is well known and discussed, too little attention is given to the underlying rationale for allowing drug developers to recoup their costs through the new intellectual property rights provided in multilateral, regional, and bilateral agreements. Known in the US as “mark...

  8. Canadian physiotherapists' views on certification, specialisation, extended role practice, and entry-level training in rheumatology

    Directory of Open Access Journals (Sweden)

    Sutton Evelyn

    2009-06-01

    Full Text Available Abstract Background Since the last decade there has been a gradual change of boundaries of health professions in providing arthritis care. In Canada, some facilities have begun to adopt new arthritis care models, some of which involve physiotherapists (PT working in extended roles. However, little is known about PTs' interests in these new roles. The primary objective of this survey was to determine the interests among orthopaedic physiotherapists (PTs in being a certified arthritis therapist, a PT specialized in arthritis, or an extended scope practitioner in rheumatology, and to explore the associated factors, including the coverage of arthritis content in the entry-level physiotherapy training. Methods Six hundred PTs practicing in orthopaedics in Canada were randomly selected to receive a postal survey. The questionnaire covered areas related to clinical practice, perceptions of rheumatology training received, and attitudes toward PT roles in arthritis care. Logistic regression models were developed to explore the associations between PTs' interests in pursuing each of the three extended scope practice designations and the personal/professional/attitudinal variables. Results We received 286 questionnaires (response rate = 47.7%; 258 contained usable data. The average length of time in practice was 15.4 years (SD = 10.4. About 1 in 4 PTs agreed that they were interested in assuming advanced practice roles (being a certified arthritis therapist = 28.9%, being a PT specialized in rheumatology = 23.3%, being a PT practitioner = 20.9%. Having a caseload of ≥ 40% in arthritis, having a positive attitude toward advanced practice roles in arthritis care and toward the formal credentialing process, and recognizing the difference between certification and specialisation were associated with an interest in pursing advanced practice roles. Conclusion Orthopaedic PTs in Canada indicated a fair level of interest in pursuing certification, specialisation

  9. Policy challenges for the pediatric rheumatology workforce: Part II. Health care system delivery and workforce supply.

    Science.gov (United States)

    Henrickson, Michael

    2011-01-01

    The United States pediatric population with chronic health conditions is expanding. Currently, this demographic comprises 12-18% of the American child and youth population. Affected children often receive fragmented, uncoordinated care. Overall, the American health care delivery system produces modest outcomes for this population. Poor, uninsured and minority children may be at increased risk for inferior coordination of services. Further, the United States health care delivery system is primarily organized for the diagnosis and treatment of acute conditions. For pediatric patients with chronic health conditions, the typical acute problem-oriented visit actually serves as a barrier to care. The biomedical model of patient education prevails, characterized by unilateral transfer of medical information. However, the evidence basis for improvement in disease outcomes supports the use of the chronic care model, initially proposed by Dr. Edward Wagner. Six inter-related elements distinguish the success of the chronic care model, which include self-management support and care coordination by a prepared, proactive team. United States health care lacks a coherent policy direction for the management of high cost chronic conditions, including rheumatic diseases. A fundamental restructure of United States health care delivery must urgently occur which places the patient at the center of care. For the pediatric rheumatology workforce, reimbursement policies and the actions of health plans and insurers are consistent barriers to chronic disease improvement. United States reimbursement policy and overall fragmentation of health care services pose specific challenges for widespread implementation of the chronic care model. Team-based multidisciplinary care, care coordination and self-management are integral to improve outcomes. Pediatric rheumatology demand in the United States far exceeds available workforce supply. This article reviews the career choice decision-making process

  10. Policy challenges for the pediatric rheumatology workforce: Part II. Health care system delivery and workforce supply

    Directory of Open Access Journals (Sweden)

    Henrickson Michael

    2011-08-01

    Full Text Available Abstract The United States pediatric population with chronic health conditions is expanding. Currently, this demographic comprises 12-18% of the American child and youth population. Affected children often receive fragmented, uncoordinated care. Overall, the American health care delivery system produces modest outcomes for this population. Poor, uninsured and minority children may be at increased risk for inferior coordination of services. Further, the United States health care delivery system is primarily organized for the diagnosis and treatment of acute conditions. For pediatric patients with chronic health conditions, the typical acute problem-oriented visit actually serves as a barrier to care. The biomedical model of patient education prevails, characterized by unilateral transfer of medical information. However, the evidence basis for improvement in disease outcomes supports the use of the chronic care model, initially proposed by Dr. Edward Wagner. Six inter-related elements distinguish the success of the chronic care model, which include self-management support and care coordination by a prepared, proactive team. United States health care lacks a coherent policy direction for the management of high cost chronic conditions, including rheumatic diseases. A fundamental restructure of United States health care delivery must urgently occur which places the patient at the center of care. For the pediatric rheumatology workforce, reimbursement policies and the actions of health plans and insurers are consistent barriers to chronic disease improvement. United States reimbursement policy and overall fragmentation of health care services pose specific challenges for widespread implementation of the chronic care model. Team-based multidisciplinary care, care coordination and self-management are integral to improve outcomes. Pediatric rheumatology demand in the United States far exceeds available workforce supply. This article reviews the career

  11. Incentives in Rheumatology: the Potential Contribution of Physician Responses to Financial Incentives, Public Reporting, and Treatment Guidelines to Health Care Sustainability.

    Science.gov (United States)

    Harrison, Mark; Milbers, Katherine; Mihic, Tamara; Anis, Aslam H

    2016-07-01

    Concerns about the sustainability of current health care expenditure are focusing attention on the cost, quality and value of health care provision. Financial incentives, for example pay-for-performance (P4P), seek to reward quality and value in health care provision. There has long been an expectation that P4P schemes are coming to rheumatology. We review the available evidence about the use of incentives in this setting and provide two emerging examples of P4P schemes which may shape the future of service provision in rheumatology. Currently, there is limited and equivocal evidence in rheumatology about the impact of incentive schemes. However, reporting variation in the quality and provision of rheumatology services has highlighted examples of inefficiencies in the delivery of care. If financial incentives can improve the delivery of timely and appropriate care for rheumatology patients, then they may have an important role to play in the sustainability of health care provision.

  12. Application of internal electrodes to the oesophageal and tracheal tube in an animal trial: evaluation of its clinical and technical potentiality in electrical impedance tomography.

    Science.gov (United States)

    Czaplik, Michael; Antink, Christoph Hoog; Rossaint, Rolf; Leonhardt, Steffen

    2014-06-01

    Electrical impedance tomography (EIT) is of potential medical interest e.g., to optimize ventilator settings during mechanical ventilation. Nevertheless there are still several challenges. Although electrode belts are commonly used and promoted, they are not necessarily adequate for the long-term monitoring of patients in intensive-care units (ICU). ICU patients are usually equipped with breathing tubes and feeding tubes, ideal surfaces to attach EIT electrodes to. The aim of our study was therefore to examine the potentiality of internal electrodes in a porcine animal trial. Following an animal trial protocol studying acute lung injury, additional EIT measurements were obtained both with conventional electrodes set upon a rubber belt and after having moved the electrodes internally in seven pigs. For this reason the two most dorsally located electrodes were selected. An adjacent stimulation and measurement pattern was used, and resulting voltages in the time and frequency domains as well as within reconstructed images were examined to compare perfusion and ventilation data qualitatively and quantitatively. Particularly, lung morphology as well as signal strength for both the mediastinal and lung region were studied. All animals were submitted to the additional protocol without any adverse events. Distinguishability of lungs was improved in reconstructed frames. The resulting sensitivity of measured electrical impedance was enhanced around the mediastinal region and even cardiac-related activity was significantly increased by a factor of up to 6. In conclusion the application of internal electrodes appears to be beneficial for diverse clinical purposes and should be addressed in further studies.

  13. State of the art on nailfold capillaroscopy: a reliable diagnostic tool and putative biomarker in rheumatology?

    Science.gov (United States)

    Cutolo, Maurizio; Smith, Vanessa

    2013-11-01

    Capillaroscopy is a non-invasive and safe tool to morphologically study the microcirculation. In rheumatology it has a dual use. First, it has a role in differential diagnosis of patients with RP. Second, it may have a role in the prediction of clinical complications in CTDs. In SSc, pilot studies have shown predictive associations with peripheral vascular and lung involvement hinting at a role of capillaroscopy as putative biomarker. Also and logically, in SSc, microangiopathy, as assessed by capillaroscopy, has been associated with markers of the disease such as angiogenic/static factors and SSc-specific antibodies. Moreover, morphological assessments of the microcirculation (capillaroscopy) seem to correlate with functional assessments (such as laser Doppler). Because of its clinical and research role, eyes are geared in Europe to expand the knowledge of this tool. Both the European League Against Rheumatism (EULAR) and the ACR are stepping forward to this need.

  14. Recommendations of the Brazilian Society of Rheumatology for the induction therapy of ANCA-associated vasculitis

    Directory of Open Access Journals (Sweden)

    Alexandre Wagner Silva de Souza

    Full Text Available Abstract The purpose of these recommendations is to guide the appropriate induction treatment of antineutrophil cytoplasmic antibody-associated vasculitis (AAV patients with active disease. The recommendations proposed by the Vasculopathies Committee of the Brazilian Society Rheumatology for induction therapy of AAV, including granulomatosis with polyangiitis, microscopic polyangiitis and renal-limited vasculitis, were based on systematic literature review and expert opinion. Literature review was performed using Medline (PubMed, EMBASE and Cochrane database to retrieve articles until October 2016. PRISMA guidelines were used for the systematic review and articles were assessed according to the Oxford levels of evidence. Sixteen recommendations were made regarding different aspects of induction therapy for AAV. The purpose of these recommendations is to serve as a guide for therapeutic decisions by health care professionals in the management of AAV patients presenting active disease.

  15. [Tubulointerstitial nephritis with uveitis (TINU) syndrome. A relatively rare rheumatological differential diagnosis with unexplained uveitis].

    Science.gov (United States)

    Häusler, U; Guminski, B; Helmchen, U; Kisters, K; Heinz, C; Braun, J

    2013-05-01

    The tubulo-interstitial nephritis and uveitis (TINU) syndrome, first described in 1975, is a rare disease most probably of autoimmune origin that is characterized by unilateral or bilateral uveitis and tubulointerstitial nephritis. Most patients are adolescents and it is sometimes associated with other autoimmune diseases, such as spondyloarthritis, rheumatoid arthritis and hyperthyroidosis. This article reports the case of a 43-year-old female patient who presented with refractory recurrent bilateral uveitis despite therapy with high doses of corticosteroids in combination with cyclosporin. When the patient was referred to this hospital for rheumatological examination after almost 1 year of therapy, mild renal insufficiency and proteinuria were found. The kidney biopsy revealed interstitial nephritis, partly crescent-shaped and partly chronic. A diagnosis of TINU syndrome was made and treatment with adalimumab in combination with methotrexate was started. The favorable clinical outcome indicated that tumor necrosis factor (TNF) alpha may play an important role in the pathogenesis of TINU syndrome.

  16. Current state of biosimilars in Mexico: The position of the Mexican College of Rheumatology, 2016.

    Science.gov (United States)

    Xibille, Daniel; Carrillo, Sandra; Huerta-Sil, Gabriela; Hernández, Ramiro; Limón, Leonardo; Olvera-Soto, Guadalupe; Jara-Quezada, Luis Javier; Esquivel, Abdieel; Pérez-Rodríguez, Marcela

    The present document is a position statement of the Mexican College of Rheumatology on the use of biosimilars in rheumatic diseases. This position considers that biosimilars should be considered as interchangeable, that automatic substitution without previous notice in stable patients during follow-up is not ethical, that the approval of a biosimilar should only be given after exhaustive review of preclinical and clinical data marked by Mexican regulations, that it should be clearly stated in the nomenclature of biologic drugs which is the innovator and which is the biosimilar, that it is not correct to choose a biosimilar as treatment based only on economic reasons or extrapolate indications based only on the approval of the innovator and in the absence of safety and efficacy data for the biosimilar. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

  17. Comparison of MAPIE versus MAP in patients with a poor response to preoperative chemotherapy for newly diagnosed high-grade osteosarcoma (EURAMOSan open-label, international, randomised controlled trial-1): an open-label, international, randomised controlled trial

    DEFF Research Database (Denmark)

    Marina, Neyssa M; Smeland, Sigbjørn; Bielack, Stefan S

    2016-01-01

    BACKGROUND: We designed the EURAMOS-1 trial to investigate whether intensified postoperative chemotherapy for patients whose tumour showed a poor response to preoperative chemotherapy (≥10% viable tumour) improved event-free survival in patients with high-grade osteosarcoma. METHODS: EURAMOS-1 wa...

  18. The 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis Phase 2 Methodological Report

    NARCIS (Netherlands)

    Neogi, Tuhina; Aletaha, Daniel; Silman, Alan J.; Naden, Raymond L.; Felson, David T.; Aggarwal, Rohit; Bingham, Clifton O.; Birnbaum, Neal S.; Burmester, Gerd R.; Bykerk, Vivian P.; Cohen, Marc D.; Combe, Bernard; Costenbader, Karen H.; Dougados, Maxime; Emery, Paul; Ferraccioli, Gianfranco; Hazes, Johanna M. W.; Hobbs, Kathryn; Huizinga, Tom W. J.; Kavanaugh, Arthur; Kay, Jonathan; Khanna, Dinesh; Kvien, Tore K.; Laing, Timothy; Liao, Katherine; Mease, Philip; Ménard, Henri A.; Moreland, Larry W.; Nair, Raj; Pincus, Theodore; Ringold, Sarah; Smolen, Josef S.; Stanislawska-Biernat, Ewa; Symmons, Deborah; Tak, Paul P.; Upchurch, Katherine S.; Vencovský, Jiří; Wolfe, Frederick; Hawker, Gillian

    2010-01-01

    Objective. The American College of Rheumatology and the European League Against Rheumatism have developed new classification criteria for rheumatoid arthritis (RA). The aim of Phase 2 of the development process was to achieve expert consensus on the clinical and laboratory variables that should

  19. The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis: Phase 2 methodological report

    NARCIS (Netherlands)

    T. Neogi (Tuhina); D. Aletaha (Daniel); A.J. Silman (Alan); R.L. Naden (Raymond); D. Felson; R. Aggarwal (Rohit); C.O. Bingham (Clifton); N.S. Birnbaum (Neal); G.R. Burmester (Gerd); V.P. Bykerk (Vivian); M.D. Cohen (Marc); B. Combe (Bernard); K.H. Costenbader (Karen); M. Dougados (Maxime); P. Emery (Paul); G. Ferraccioli (Gianfranco); J.M.W. Hazes (Mieke); K. Hobbs (Kathryn); T.W.J. Huizinga (Tom); A. Kavanaugh (Arthur); J. Kay (Jonathan); D. Khanna (Dinesh); T.K. Kvien (Tore); T. Laing (Timothy); K. Liao (Katherine); P. Mease (Philip); H.A. Ménard (Henri); L.W. Moreland (Larry); R. Nair (Raj); T. Pincus (Theodore); S. Ringold (Sarah); J.S. Smolen (Josef); E. Stanislawska-Biernat (Ewa); D. Symmons (Deborah); P.P. Tak (Paul); K.S. Upchurch (Katherine); J. Vencovský (Jiří); F. Wolfe (Frederick); G. Hawker (Gillian)

    2010-01-01

    textabstractObjective. The American College of Rheumatology and the European League Against Rheumatism have developed new classification criteria for rheumatoid arthritis (RA). The aim of Phase 2 of the development process was to achieve expert consensus on the clinical and laboratory variables that

  20. Giving rheumatology patients online home access to their electronic medical record (EMR): advantages, drawbacks and preconditions according to care providers

    NARCIS (Netherlands)

    van der Vaart, R.; Drossaert, Constance H.C.; Taal, Erik; van de Laar, Mart A F J

    2013-01-01

    Technology enables patients home access to their electronic medical record (EMR), via a patient portal. This study aims to analyse (dis)advantages, preconditions and suitable content for this service, according to rheumatology health professionals. A two-phase policy Delphi study was conducted.

  1. Adaptation of the 2015 American College of Rheumatology treatment guideline for rheumatoid arthritis for the Eastern Mediterranean Region

    DEFF Research Database (Denmark)

    Darzi, Andrea; Harfouche, Manale; Arayssi, Thurayya

    2017-01-01

    BACKGROUND: It has been hypothesized that adaptation of health practice guidelines to the local setting is expected to improve their uptake and implementation while cutting on required resources. We recently adapted the published American College of Rheumatology (ACR) Rheumatoid Arthritis (RA) tr...

  2. Beetroot Juice Improves On-Water 500 M Time-Trial Performance, and Laboratory-Based Paddling Economy in National and International-Level Kayak Athletes.

    Science.gov (United States)

    Peeling, Peter; Cox, Gregory R; Bullock, Nicola; Burke, Louise M

    2015-06-01

    We assessed the ingestion of a beetroot juice supplement (BR) on 4-min laboratory-based kayak performance in national level male (n = 6) athletes (Study A), and on 500 m on-water kayak time-trial (TT) performance in international level female (n = 5) athletes (Study B). In Study A, participants completed three laboratory-based sessions on a kayak ergometer, including a 7 × 4 min step test, and two 4 min maximal effort performance trials. Two and a half hours before the warm-up of each 4 min performance trial, athletes received either a 70 ml BR shot containing ~4.8 mmol of nitrate, or a placebo equivalent (BRPLA). The distance covered over the 4 min TT was not different between conditions; however, the average VO2 over the 4 min period was significantly lower in BR (p = .04), resulting in an improved exercise economy (p = .05). In Study B, participants completed two field-based 500 m TTs, separated by 4 days. Two hours before each trial, athletes received either two 70 ml BR shots containing ~9.6 mmol of nitrate, or a placebo equivalent (BRPLA). BR supplementation significantly enhanced TT performance by 1.7% (p = .01). Our results show that in national-level male kayak athletes, commercially available BR shots (70 ml) containing ~4.8 mmol of nitrate improved exercise economy during laboratory-based tasks predominantly reliant on the aerobic energy system. Furthermore, greater volumes of BR (140 ml; ~9.6 mmol nitrate) provided to international-level female kayak athletes resulted in enhancements to TT performance in the field.

  3. A Brief History of IL-1 and IL-1 Ra in Rheumatology

    Directory of Open Access Journals (Sweden)

    Jean-Michel Dayer

    2017-05-01

    Full Text Available The history of what, in 1979, was called interleukin-1 (IL-1, orchestrator of leukocyte inter-communication, began many years before then, initially by the observation of fever induction via the endogenous pyrogen (EP (1974 and then in rheumatology on the role in tissue destruction in rheumatoid diseases via the induction of collagenase and PGE2 in human synovial cells by a mononuclear cell factor (MCF (1977. Since then, the family has exploded to presently 11 members as well as many membrane-bound and soluble receptor forms. The discovery of a natural Interleukin-1 receptor antagonist (IL-1Ra in human biological fluids has highlighted the importance of IL-1 and IL-1Ra in human diseases. Evidence delineating its role in autoinflammatory syndromes and the elucidation of the macromolecular complex referred to as “inflammasome” have been instrumental to our understanding of the link with IL-1. At present, the IL-1blockade as therapeutic approach is crucial for many hereditary autoinflammatory diseases, as well as for adult-onset Still’s disease, crystal-induced arthropathies, certain skin diseases including neutrophil-triggered skin diseases, Behçet’s disease and deficiency of IL-1Ra and other rare fever syndromes. Its role is only marginally important in rheumatoid arthritis and is still under debate with regard to osteoarthritis, type 2 diabetes mellitus, cardiovascular diseases and cancer. This brief historical review focuses on some aspects of IL-1, mainly IL-1β and IL-Ra, in rheumatology. There are many excellent reviews focusing on the IL-1 family in general or with regard to specific diseases or biological discoveries.

  4. Impact of the 2012 London Olympic and Paralympic Games on physical activity of rheumatology patients.

    Science.gov (United States)

    Müther, Michael; Williamson, Marie; Williamson, Lyn

    2014-10-01

    Lack of physical activity in the general population is one of the biggest health challenges we face. For rheumatology patients, and other patients with chronic disease, exercise is an essential part of disease management. However, very few patients exercise effectively.One of the aspirations of the London 2012 Olympic/Paralympic Games was to catalyze people into long-term physical activity. We surveyed our rheumatology patients at 3 high-profile times in the year after the Olympics. Two hundred fifty-three patients were enrolled within the study; the largest diagnosis subgroup being rheumatoid arthritis (36%). Ninety-five percent of our patients regard exercise as beneficial; 36% still think it does harm. Most common barriers to exercise were pain (53%), tiredness (44%), and lack of time (36%). Forty-five percent exercise daily, mostly just walking. Twnety-seven patients (16%) were motivated by the 2012 Olympic and Paralympic Games toward physical activity. They were mostly motivated by athletics' individual stories (67%), taking part in a big sports festival (11%) and demonstration of top sporting levels (4%). Eighteen patients in total (7%) increased their amount of exercise in response to the London 2012 Olympic and Paralympic Games. There was no difference between patient diagnostic groups. Only a small minority of patients increased their amount of exercise in response to the 2012 Olympic and Paralympic Games. The message about the importance of physical exercise to health needs to be clear, unambiguous, and consistent, because a significant number of patients still think that physical activity does harm. Big sporting events such as the London 2012 Olympic and Paralympic Games can be used as an opportunity to remind patients that physical activity does good and is not harmful. Athletes' individual stories could be used in future as part of a strategy to encourage exercise for all patients.

  5. Evaluation of a novel 7-joint ultrasound score in daily rheumatologic practice: a pilot project.

    Science.gov (United States)

    Backhaus, M; Ohrndorf, S; Kellner, H; Strunk, J; Backhaus, T M; Hartung, W; Sattler, H; Albrecht, K; Kaufmann, J; Becker, K; Sörensen, H; Meier, L; Burmester, G R; Schmidt, W A

    2009-09-15

    To introduce a new standardized ultrasound score based on 7 joints of the clinically dominant hand and foot (German US7 score) implemented in daily rheumatologic practice. The ultrasound score included the following joints of the clinically dominant hand and foot: wrist, second and third metacarpophalangeal and proximal interphalangeal, and second and fifth metatarsophalangeal joints. Synovitis and synovial/tenosynovial vascularity were scored semiquantitatively (grade 0-3) by gray-scale (GS) and power Doppler (PD) ultrasound. Tenosynovitis and erosions were scored for presence. The scoring range was 0-27 for GS synovitis, 0-39 for PD synovitis, 0-7 for GS tenosynovitis, 0-21 for PD tenosynovitis, and 0-14 for erosions. Patients with arthritis were examined at baseline and after the start or change of disease-modifying antirheumatic drug (DMARD) and/or tumor necrosis factor alpha (TNFalpha) inhibitor therapy 3 and 6 months later. C-reactive protein level, erythrocyte sedimentation rate, rheumatoid factor, anti-cyclic citrullinated peptide, Disease Activity Score in 28 joints (DAS28), and radiographs of the hands and feet were performed. One hundred twenty patients (76% women) with rheumatoid arthritis (91%) and psoriatic arthritis (9%) were enrolled. In 52 cases (43%), erosions were seen in radiography at baseline. Patients received DMARDs (41%), DMARDs plus TNFalpha inhibitors (41%), or TNFalpha inhibitor monotherapy (18%). At baseline, the mean DAS28 was 5.0 and the synovitis scores were 8.1 in GS ultrasound and 3.3 in PD ultrasound. After 6 months of therapy, the DAS28 significantly decreased to 3.6 (Delta = 1.4), and the GS and PD ultrasound scores significantly decreased to 5.5 (-32%) and 2.0 (-39%), respectively. The German US7 score is a viable tool for examining patients with arthritis in daily rheumatologic practice because it significantly reflects therapeutic response.

  6. Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice.

    Science.gov (United States)

    Anderson, Jaclyn; Caplan, Liron; Yazdany, Jinoos; Robbins, Mark L; Neogi, Tuhina; Michaud, Kaleb; Saag, Kenneth G; O'Dell, James R; Kazi, Salahuddin

    2012-05-01

    Although the systematic measurement of disease activity facilitates clinical decision making in rheumatoid arthritis (RA), no recommendations currently exist on which measures should be applied in clinical practice in the US. The American College of Rheumatology (ACR) convened a Working Group (WG) to comprehensively evaluate the validity, feasibility, and acceptability of available RA disease activity measures and derive recommendations for their use in clinical practice. The Rheumatoid Arthritis Clinical Disease Activity Measures Working Group conducted a systematic review of the literature to identify RA disease activity measures. Using exclusion criteria, input from an Expert Advisory Panel (EAP), and psychometric analysis, a list of potential measures was created. A survey was administered to rheumatologists soliciting input. The WG used these survey results in conjunction with the psychometric analyses to derive final recommendations. Systematic review of the literature resulted in identification of 63 RA disease activity measures. Application of exclusion criteria and ratings by the EAP narrowed the list to 14 measures for further evaluation. Practicing rheumatologists rated 9 of these 14 measures as most useful and feasible. From these 9 measures, the WG selected 6 with the best psychometric properties for inclusion in the final set of ACR-recommended RA disease activity measures. We recommend the Clinical Disease Activity Index, Disease Activity Score with 28-joint counts (erythrocyte sedimentation rate or C-reactive protein), Patient Activity Scale (PAS), PAS-II, Routine Assessment of Patient Index Data with 3 measures, and Simplified Disease Activity Index because they are accurate reflections of disease activity; are sensitive to change; discriminate well between low, moderate, and high disease activity states; have remission criteria; and are feasible to perform in clinical settings. Copyright © 2012 by the American College of Rheumatology.

  7. A randomized comparison of the Saphenous Vein Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE RITA) trial: early results.

    Science.gov (United States)

    Hwang, Ho Young; Kim, Jun Sung; Oh, Se Jin; Kim, Ki-Bong

    2012-11-01

    The Saphenous Vein Versus Right Internal Thoracic Artery as a Y-Composite Graft trial was designed to evaluate the saphenous vein compared with the right internal thoracic artery as a Y-composite graft anastomosed to the side of the left internal thoracic artery. In this early analysis, we compared early angiographic patency rates and clinical outcomes. From September 2008 to October 2011, 224 patients with multivessel coronary artery disease were randomized prospectively to undergo off-pump revascularization using the saphenous vein group (n = 112) or the right internal thoracic artery group (n = 112) as Y-composite grafts. Early postoperative (1.4 ± 1.1 days) angiographic patency and clinical outcomes were compared. There was 1 operative death in the right internal thoracic artery group. No statistically significant differences in postoperative morbidities, including atrial fibrillation and acute renal failure, were observed between the groups. The number of distal anastomoses using the side-arm Y-composite graft (saphenous vein vs right internal thoracic artery) were 2.3 ± 0.8 and 1.9 ± 0.7 in the saphenous vein and right internal thoracic artery groups, respectively (P < .001). A third conduit was used in 44 patients (saphenous vein group vs right internal thoracic artery group, 4/109 vs 40/110; P < .001) to extend the side-arm Y-composite graft for complete revascularization. Early angiography demonstrated an overall patency rate of 99.4% (771 of 776 distal anastomoses). Patency rates of the side-arm Y-composite graft (saphenous vein vs right internal thoracic artery) were 98.8% (245 of 248) and 99.5% (207 of 208) in the saphenous vein and right internal thoracic artery groups, respectively (P = .629). A third conduit was needed to extend the right internal thoracic artery composite graft and reach the target vessels in 36.4% (40/110) of the patients. The saphenous vein composite graft was comparable with the right internal thoracic artery composite graft

  8. RETHINKING THE ROLE OF CLINICAL TRIAL DATA IN INTERNATIONAL INTELLECTUAL PROPERTY LAW: THE CASE FOR A PUBLIC GOODS APPROACH

    Science.gov (United States)

    REICHMAN, JEROME H.

    2009-01-01

    This article describes the growth and consequences of new intellectual property rights given to pharmaceutical developers, and it advocates treating clinical trials as a public good. Although the soaring cost of clinical trials is well known and discussed, too little attention is given to the underlying rationale for allowing drug developers to recoup their costs through the new intellectual property rights provided in multilateral, regional, and bilateral agreements. Known in the US as “market exclusivity” and in Europe as “data exclusivity,” these rights prohibit would-be generic producers from obtaining regulatory approval based on the original producers’ undisclosed test data. Market and data exclusivity is codified in US and European domestic law as well as the North American Free Trade Agreement (NAFTA) and, to a lesser degree, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Market and data exclusivity is binding an increasing number of developing countries via Free Trade Agreements (FTAs), which hinder developing countries from manufacturing generic drugs. At a minimum, negotiators should replace the norm of exclusive control over data with a liability rule, or take and pay rule, in which generic manufacturers can use original manufacturers’ clinical trial data in exchange for reasonable compensation. A more fundamental solution requires questioning the status quo of proprietary clinical trial data. The conventional wisdom is that market and data exclusivity, and drug developers’ consequent ability to limit competition from generics above and beyond patent protection, are a necessary incentive for drug developers to fund ever more expensive clinical trials. Clinical trial data, however, are public goods that will be undersupplied and over protected so long as private actors provide them. Moreover, manufacturers have an incentive to present clinical trial data so that they support regulatory approval at the

  9. RETHINKING THE ROLE OF CLINICAL TRIAL DATA IN INTERNATIONAL INTELLECTUAL PROPERTY LAW: THE CASE FOR A PUBLIC GOODS APPROACH.

    Science.gov (United States)

    Reichman, Jerome H

    2009-01-01

    This article describes the growth and consequences of new intellectual property rights given to pharmaceutical developers, and it advocates treating clinical trials as a public good. Although the soaring cost of clinical trials is well known and discussed, too little attention is given to the underlying rationale for allowing drug developers to recoup their costs through the new intellectual property rights provided in multilateral, regional, and bilateral agreements. Known in the US as "market exclusivity" and in Europe as "data exclusivity," these rights prohibit would-be generic producers from obtaining regulatory approval based on the original producers' undisclosed test data. Market and data exclusivity is codified in US and European domestic law as well as the North American Free Trade Agreement (NAFTA) and, to a lesser degree, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Market and data exclusivity is binding an increasing number of developing countries via Free Trade Agreements (FTAs), which hinder developing countries from manufacturing generic drugs. At a minimum, negotiators should replace the norm of exclusive control over data with a liability rule, or take and pay rule, in which generic manufacturers can use original manufacturers' clinical trial data in exchange for reasonable compensation. A more fundamental solution requires questioning the status quo of proprietary clinical trial data. The conventional wisdom is that market and data exclusivity, and drug developers' consequent ability to limit competition from generics above and beyond patent protection, are a necessary incentive for drug developers to fund ever more expensive clinical trials. Clinical trial data, however, are public goods that will be undersupplied and over protected so long as private actors provide them. Moreover, manufacturers have an incentive to present clinical trial data so that they support regulatory approval at the expense of public

  10. Dealing with the Principle of Proportionality in Armed Conflict in Retrospect: The Application of the Principle in International Criminal Trials

    NARCIS (Netherlands)

    Bartels, R.

    2013-01-01

    The principle of proportionality is one of the core principles of international humanitarian law. The principle is not easy to apply on the battlefield, but is even harder to apply retrospectively, in the courtroom. This article discusses the challenges in applying the principle during international

  11. Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME)

    NARCIS (Netherlands)

    Chalmers, J. R.; Schmitt, J.; Apfelbacher, C.; Dohil, M.; Eichenfield, L. F.; Simpson, E. L.; Singh, J.; Spuls, P.; Thomas, K. S.; Admani, S.; Aoki, V.; Ardeleanu, M.; Barbarot, S.; Berger, T.; Bergman, J. N.; Block, J.; Borok, N.; Burton, T.; Chamlin, S. L.; Deckert, S.; DeKlotz, C. C.; Graff, L. B.; Hanifin, J. M.; Hebert, A. A.; Humphreys, R.; Katoh, N.; Kisa, R. M.; Margolis, D. J.; Merhand, S.; Minnillo, R.; Mizutani, H.; Nankervis, H.; Ohya, Y.; Rodgers, P.; Schram, M. E.; Stalder, J. F.; Svensson, A.; Takaoka, R.; Teper, A.; Tom, W. L.; von Kobyletzki, L.; Weisshaar, E.; Zelt, S.; Williams, H. C.

    2014-01-01

    This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6-7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial:

  12. Clinical and cost-effectiveness of internal limiting membrane peeling for patients with idiopathic full thickness macular hole. Protocol for a Randomised Controlled Trial: FILMS (Full-thickness macular hole and Internal Limiting Membrane peeling Study

    Directory of Open Access Journals (Sweden)

    Cook Jonathan

    2008-11-01

    Full Text Available Abstract Background A full-thickness macular hole (FTMH is a common retinal condition associated with impaired vision. Randomised controlled trials (RCTs have demonstrated that surgery, by means of pars plana vitrectomy and post-operative intraocular tamponade with gas, is effective for stage 2, 3 and 4 FTMH. Internal limiting membrane (ILM peeling has been introduced as an additional surgical manoeuvre to increase the success of the surgery; i.e. increase rates of hole closure and visual improvement. However, little robust evidence exists supporting the superiority of ILM peeling compared with no-peeling techniques. The purpose of FILMS (Full-thickness macular hole and Internal Limiting Membrane peeling Study is to determine whether ILM peeling improves the visual function, the anatomical closure of FTMH, and the quality of life of patients affected by this disorder, and the cost-effectiveness of the surgery. Methods/Design Patients with stage 2–3 idiopathic FTMH of less or equal than 18 months duration (based on symptoms reported by the participant and with a visual acuity ≤ 20/40 in the study eye will be enrolled in this FILMS from eight sites across the UK and Ireland. Participants will be randomised to receive combined cataract surgery (phacoemulsification and intraocular lens implantation and pars plana vitrectomy with postoperative intraocular tamponade with gas, with or without ILM peeling. The primary outcome is distance visual acuity at 6 months. Secondary outcomes include distance visual acuity at 3 and 24 months, near visual acuity at 3, 6, and 24 months, contrast sensitivity at 6 months, reading speed at 6 months, anatomical closure of the macular hole at each time point (1, 3, 6, and 24 months, health related quality of life (HRQOL at six months, costs to the health service and the participant, incremental costs per quality adjusted life year (QALY and adverse events. Discussion FILMS will provide high quality evidence on the

  13. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards.

    Science.gov (United States)

    Bottomley, Andrew; Pe, Madeline; Sloan, Jeff; Basch, Ethan; Bonnetain, Franck; Calvert, Melanie; Campbell, Alicyn; Cleeland, Charles; Cocks, Kim; Collette, Laurence; Dueck, Amylou C; Devlin, Nancy; Flechtner, Hans-Henning; Gotay, Carolyn; Greimel, Eva; Griebsch, Ingolf; Groenvold, Mogens; Hamel, Jean-Francois; King, Madeleine; Kluetz, Paul G; Koller, Michael; Malone, Daniel C; Martinelli, Francesca; Mitchell, Sandra A; Moinpour, Carol M; Musoro, Jammbe; O'Connor, Daniel; Oliver, Kathy; Piault-Louis, Elisabeth; Piccart, Martine; Pimentel, Francisco L; Quinten, Chantal; Reijneveld, Jaap C; Schürmann, Christoph; Smith, Ashley Wilder; Soltys, Katherine M; Taphoorn, Martin J B; Velikova, Galina; Coens, Corneel

    2016-11-01

    Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. ICT-based system to predict and prevent falls (iStoppFalls): results from an international multicenter randomized controlled trial.

    Science.gov (United States)

    Gschwind, Yves J; Eichberg, Sabine; Ejupi, Andreas; de Rosario, Helios; Kroll, Michael; Marston, Hannah R; Drobics, Mario; Annegarn, Janneke; Wieching, Rainer; Lord, Stephen R; Aal, Konstantin; Vaziri, Daryoush; Woodbury, Ashley; Fink, Dennis; Delbaere, Kim

    2015-01-01

    Falls and fall-related injuries are a serious public health issue. Exercise programs can effectively reduce fall risk in older people. The iStoppFalls project developed an Information and Communication Technology-based system to deliver an unsupervised exercise program in older people's homes. The primary aims of the iStoppFalls randomized controlled trial were to assess the feasibility (exercise adherence, acceptability and safety) of the intervention program and its effectiveness on common fall risk factors. A total of 153 community-dwelling people aged 65+ years took part in this international, multicentre, randomized controlled trial. Intervention group participants conducted the exercise program for 16 weeks, with a recommended duration of 120 min/week for balance exergames and 60 min/week for strength exercises. All intervention and control participants received educational material including advice on a healthy lifestyle and fall prevention. Assessments included physical and cognitive tests, and questionnaires for health, fear of falling, number of falls, quality of life and psychosocial outcomes. The median total exercise duration was 11.7 h (IQR = 22.0) over the 16-week intervention period. There were no adverse events. Physiological fall risk (Physiological Profile Assessment, PPA) reduced significantly more in the intervention group compared to the control group (F1,127 = 4.54, p = 0.035). There was a significant three-way interaction for fall risk assessed by the PPA between the high-adherence (>90 min/week; n = 18, 25.4 %), low-adherence (<90 min/week; n = 53, 74.6 %) and control group (F2,125 = 3.12, n = 75, p = 0.044). Post hoc analysis revealed a significantly larger effect in favour of the high-adherence group compared to the control group for fall risk (p = 0.031), postural sway (p = 0.046), stepping reaction time (p = 0.041), executive functioning (p = 0.044), and quality of life (p for

  15. ICT-based system to predict and prevent falls (iStoppFalls): study protocol for an international multicenter randomized controlled trial.

    Science.gov (United States)

    Gschwind, Yves J; Eichberg, Sabine; Marston, Hannah R; Ejupi, Andreas; Rosario, Helios de; Kroll, Michael; Drobics, Mario; Annegarn, Janneke; Wieching, Rainer; Lord, Stephen R; Aal, Konstantin; Delbaere, Kim

    2014-08-20

    Falls are very common, especially in adults aged 65 years and older. Within the current international European Commission's Seventh Framework Program (FP7) project 'iStoppFalls' an Information and Communication Technology (ICT) based system has been developed to regularly assess a person's risk of falling in their own home and to deliver an individual and tailored home-based exercise and education program for fall prevention. The primary aims of iStoppFalls are to assess the feasibility and acceptability of the intervention program, and its effectiveness to improve balance, muscle strength and quality of life in older people. This international, multicenter study is designed as a single-blinded, two-group randomized controlled trial. A total of 160 community-dwelling older people aged 65 years and older will be recruited in Germany (n = 60), Spain (n = 40), and Australia (n = 60) between November 2013 and May 2014. Participants in the intervention group will conduct a 16-week exercise program using the iStoppFalls system through their television set at home. Participants are encouraged to exercise for a total duration of 180 minutes per week. The training program consists of a variety of balance and strength exercises in the form of video games using exergame technology. Educational material about a healthy lifestyle will be provided to each participant. Final reassessments will be conducted after 16 weeks. The assessments include physical and cognitive tests as well as questionnaires assessing health, fear of falling, quality of life and psychosocial determinants. Falls will be followed up for six months by monthly falls calendars. We hypothesize that the regular use of this newly developed ICT-based system for fall prevention at home is feasible for older people. By using the iStoppFalls sensor-based exercise program, older people are expected to improve in balance and strength outcomes. In addition, the exercise training may have a positive impact on quality of

  16. A review of the literature analyzing benefits and concerns of infliximab biosimilar CT-P13 for the treatment of rheumatologic diseases: focus on interchangeability.

    Science.gov (United States)

    Becciolini, Andrea; Raimondo, Maria Gabriella; Crotti, Chiara; Agape, Elena; Biggioggero, Martina; Favalli, Ennio Giulio

    2017-01-01

    The introduction of biological agents drastically changed the treatment paradigm of inflammatory arthritides, ameliorating the natural history of the diseases but concomitantly increasing the drug costs due to the manufacturing process. On this concern, biosimilar drugs may represent a valid option for reducing this elevated cost and increasing the availability of these highly effective treatments. Recently, CT-P13, the first biosimilar of infliximab, has been approved with the same indications established for the reference product (RP), and its daily use is progressively increasing. However, the experience with biosimilar drugs in the field of rheumatology is still limited, raising potential doubts and concerns on their correct management in real-life settings. Comparability analysis between CT-P13 and its RP was evaluated in equivalence randomized controlled trials (RCTs) - PLANETRA and PLANETAS - performed on patients with rheumatoid arthritis and axial spondylitis, respectively. CT-P13 and RP showed similar profile in terms of quality, biological activity, safety, immunogenicity, and efficacy. However, the interchangeability between infliximab RP and its biosimilar still represents the most challenging issue because of a lack of a long-lasting experience. To date, reassuring preliminary data on this topic were reported in open-label extensions of PLANETRA and PLANETAS RCTs and in ongoing real-life observational studies. These findings, taken all together, significantly affect the landscape of biosimilar regulatory pathways and strongly support CT-P13 introduction as a great opportunity for expanding the accessibility to these very effective and high-cost therapies.

  17. Ponatinib versus imatinib for newly diagnosed chronic myeloid leukaemia: an international, randomised, open-label, phase 3 trial.

    Science.gov (United States)

    Lipton, Jeffrey H; Chuah, Charles; Guerci-Bresler, Agnès; Rosti, Gianantonio; Simpson, David; Assouline, Sarit; Etienne, Gabriel; Nicolini, Franck E; le Coutre, Philipp; Clark, Richard E; Stenke, Leif; Andorsky, David; Oehler, Vivian; Lustgarten, Stephanie; Rivera, Victor M; Clackson, Timothy; Haluska, Frank G; Baccarani, Michele; Cortes, Jorge E; Guilhot, François; Hochhaus, Andreas; Hughes, Timothy; Kantarjian, Hagop M; Shah, Neil P; Talpaz, Moshe; Deininger, Michael W

    2016-05-01

    Ponatinib has shown potent activity against chronic myeloid leukaemia that is resistant to available treatment, although it is associated with arterial occlusion. We investigated whether this activity and safety profile would result in superior outcomes compared with imatinib in previously untreated patients with chronic myeloid leukaemia. The Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia (EPIC) study was a randomised, open-label, phase 3 trial designed to assess the efficacy and safety of ponatinib, compared with imatinib, in newly diagnosed patients with chronic-phase chronic myeloid leukaemia. Patients from 106 centres in 21 countries were randomly assigned (1:1, with stratification by Sokal score at diagnosis) using an interactive voice and web response system to receive oral ponatinib (45 mg) or imatinib (400 mg) once daily until progression, unacceptable toxicity, or other criteria for withdrawal were met. Eligible patients were at least 18 years of age, within 6 months of diagnosis, and Philadelphia chromosome-positive by cytogenetic assessment, with Eastern Cooperative Oncology Group performance status of 0-2, and had not previously been treated with tyrosine kinase inhibitors. The primary endpoint was major molecular response at 12 months. Patients who remained on study and had molecular assessments at specified timepoints were studied at those timepoints. Safety analyses included all treated patients, as per study protocol. This trial is registered with ClinicalTrials.gov, number NCT01650805. Between Aug 14, 2012, and Oct 9, 2013, 307 patients were randomly assigned to receive ponatinib (n=155) or imatinib (n=152). The trial was terminated early, on Oct 17, 2013, following concerns about vascular adverse events observed in patients given ponatinib in other trials. Trial termination limited assessment of the primary endpoint of major molecular response at 12 months, as only 13 patients in the imatinib group and ten patients in the

  18. Methodology for Speech Assessment in the Scandcleft Project-An International Randomized Clinical Trial on Palatal Surgery

    DEFF Research Database (Denmark)

    Willadsen, Elisabeth

    2009-01-01

    Objective: To present the methodology for speech assessment in the Scandcleft project and discuss issues from a pilot study. Design: Description of methodology and blinded test for speech assessment. Speech samples and instructions for data collection and analysis for comparisons of speech outcomes...... across five included languages were developed and tested. Participants and Materials: Randomly selected video recordings of 10 5-year-old children from each language (n = 50) were included in the project. Speech material consisted of test consonants in single words, connected speech, and syllable chains......-sum and the overall rating of VPC was 78%. Conclusions: Pooling data of speakers of different languages in the same trial and comparing speech outcome across trials seems possible if the assessment of speech concerns consonants and is confined to speech units that are phonetically similar across languages. Agreed...

  19. Can we decide which outcomes should be measured in every clinical trial? A scoping review of the existing conceptual frameworks and processes to develop core outcome sets.

    Science.gov (United States)

    Idzerda, Leanne; Rader, Tamara; Tugwell, Peter; Boers, Maarten

    2014-05-01

    The usefulness of randomized control trials to advance clinical care depends upon the outcomes reported, but disagreement on the choice of outcome measures has resulted in inconsistency and the potential for reporting bias. One solution to this problem is the development of a core outcome set: a minimum set of outcome measures deemed critical for clinical decision making. Within rheumatology the Outcome Measures in Rheumatology (OMERACT) initiative has pioneered the development of core outcome sets since 1992. As the number of diseases addressed by OMERACT has increased and its experience in formulating core sets has grown, clarification and update of the conceptual framework and formulation of a more explicit process of area/domain core set development has become necessary. As part of the update process of the OMERACT Filter criteria to version 2, a literature review was undertaken to compare and contrast the OMERACT conceptual framework with others within and outside rheumatology. A scoping search was undertaken to examine the extent, range, and nature of conceptual frameworks for core set outcome selection in health. We searched the following resources: Cochrane Library Methods Group Register; Medline; Embase; PsycInfo; Environmental Studies and Policy Collection; and ABI/INFORM Global. We also conducted a targeted Google search. Five conceptual frameworks were identified: the WHO tripartite definition of health; the 5 Ds (discomfort, disability, drug toxicity, dollar cost, and death); the International Classification of Functioning (ICF); PROMIS (Patient-Reported Outcomes Measurement System); and the Outcomes Hierarchy. Of these, only the 5 Ds and ICF frameworks have been systematically applied in core set development. Outside the area of rheumatology, several core sets were identified; these had been developed through a limited range of consensus-based methods with varying degrees of methodological rigor. None applied a framework to ensure content validity of

  20. Therapy reduction in patients with Down syndrome and myeloid leukemia: the international ML-DS 2006 trial.

    Science.gov (United States)

    Uffmann, Madita; Rasche, Mareike; Zimmermann, Martin; von Neuhoff, Christine; Creutzig, Ursula; Dworzak, Michael; Scheffers, Lenie; Hasle, Henrik; Zwaan, C Michel; Reinhardt, Dirk; Klusmann, Jan-Henning

    2017-06-22

    Children with myeloid leukemia associated with Down syndrome (ML-DS) have superior outcome compared with non-DS patients, but suffer from higher constitutional cytotoxic drug susceptibility. We analyzed the outcome of 170 pediatric patients with ML-DS enrolled in the prospective, multicenter, open-label, nonrandomized ML-DS 2006 trial by Nordic Society for Pediatric Hematology and Oncology (NOPHO), Dutch Childhood Oncology Group (DCOG), and Acute Myeloid Leukemia-Berlin-Frankfurt-Münster (AML-BFM) study group. Compared with the historical control arm (reduced-intensity protocol for ML-DS patients from the AML-BFM 98 trial), treatment intensity was reduced by lowering the cumulative dose of etoposide (950 to 450 mg/m 2 ) and intrathecal central nervous system prophylaxis while omitting maintenance therapy. Still, 5-year overall survival (89% ± 3% vs 90% ± 4%; P log-rank = .64), event-free survival (EFS; 87% ± 3% vs 89% ± 4%; P log-rank = .71), and cumulative incidence of relapse/nonresponse (CIR/NR; 6% ± 3% vs 6% ± 2%; P Gray = .03) did not significantly differ between the ML-DS 2006 trial and the historical control arm. Poor early treatment response (5-year EFS, 58% ± 16% vs 88% ± 3%; P log rank = .0008) and gain of chromosome 8 (CIR/NR, 16% ± 7% vs 3% ± 2%, P Gray = .02; 5-year EFS, 73% ± 8% vs 91% ± 4%, P log rank = .018) were identified as independent prognostic factors predicting a worse EFS. Five of 7 relapsed patients (71%) with cytogenetic data had trisomy 8. Our study reveals prognostic markers for children with ML-DS and illustrates that reducing therapy did not impair excellent outcome. The trial was registered at EudraCT as #2007-006219-2. © 2017 by The American Society of Hematology.

  1. Septic arthritis: a 12 years retrospective study in a rheumatological university clinic

    Directory of Open Access Journals (Sweden)

    L. Riato

    2011-09-01

    Full Text Available Background: Septic arthritis is a disabling and potentially life-threatening condition that requires prompt diagnosis and treatment. The most important risk factors are joint prosthesis, pre-existing joint disease and immunosuppressive drugs. The aim of our study therefore was to revaluate all septic arthritis cases discharged from our Rheumatologic Unit in the last 12 years, to assess the risk factors, the clinical and laboratory characteristics, the causative microorganisms and its possible increase in frequency. Methods: The medical records of 42 consecutive patients with septic arthritis discharged from our Rheumatology Unit between January 1995 and December 2006 were reviewed. The patients ranged in age from 23 to 90 and there isn’t gender predominance. Septic arthritis was diagnosed based on the finding of purulent material in the joint space and/or the isolation of a bacterial pathogen from joint fluid. Demographic data, risk factors, co-morbidity, clinical manifestations, time interval between symptoms onset and diagnosis, treatment and laboratory data including serum white blood cell count, erythrocyte sedimentation rate (ESR, C reactive protein (CRP, synovial white blood cells and culture results were analysed. We considered these parameters in the whole population and in two different age groups (≤60, >60 and tried to determine if there was a change of microorganisms involved in septic arthritis during the years. Results: Of 42 patients, 47% were aged 60 and younger. Only 10 patients were admitted to our unit before 2001. A predisposing factor was recorded in 90,5% of cases: 15 patients had rheumatoid arthritis, 8 were diabetic, 6 had seronegative arthritis, 4 had a connective tissue disease, 8 patients had a prosthetic infection and 3 were subjected recently to arthrocentesis. We found that patients aged 60 and younger were more frequently affected by joint disease and had a synovial white blood cell count lower than patients

  2. A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT: study protocol and design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kruger Peter

    2011-03-01

    Full Text Available Abstract Background Swine origin influenza A/H1N1 infection (H1N1 emerged in early 2009 and rapidly spread to humans. For most infected individuals, symptoms were mild and self-limited; however, a small number developed a more severe clinical syndrome characterized by profound respiratory failure with hospital mortality ranging from 10 to 30%. While supportive care and neuraminidase inhibitors are the main treatment for influenza, data from observational and interventional studies suggest that the course of influenza can be favorably influenced by agents not classically considered as influenza treatments. Multiple observational studies have suggested that HMGCoA reductase inhibitors (statins can exert a class effect in attenuating inflammation. The Collaborative H1N1 Adjuvant Treatment (CHAT Pilot Trial sought to investigate the feasibility of conducting a trial during a global pandemic in critically ill patients with H1N1 with the goal of informing the design of a larger trial powered to determine impact of statins on important outcomes. Methods/Design A multi-national, pilot randomized controlled trial (RCT of once daily enteral rosuvastatin versus matched placebo administered for 14 days for the treatment of critically ill patients with suspected, probable or confirmed H1N1 infection. We propose to randomize 80 critically ill adults with a moderate to high index of suspicion for H1N1 infection who require mechanical ventilation and have received antiviral therapy for ≤ 72 hours. Site investigators, research coordinators and clinical pharmacists will be blinded to treatment assignment. Only research pharmacy staff will be aware of treatment assignment. We propose several approaches to informed consent including a priori consent from the substitute decision maker (SDM, waived and deferred consent. The primary outcome of the CHAT trial is the proportion of eligible patients enrolled in the study. Secondary outcomes will evaluate adherence to

  3. Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME)

    OpenAIRE

    Chalmers, JR; Schmitt, J; Apfelbacher, C; Dohil, M; Eichenfield, LF; Simpson, EL; Singh, J; Spuls, P; Thomas, KS; Admani, S; Aoki, V; Ardeleanu, M; Barbarot, S; Berger, T; Bergman, JN

    2014-01-01

    Summary This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6?7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial: clinical signs, patient-reported symptoms, long-term control and quality of life. Formal presentations and nominal group techniques were used at this working meeting, attended by 56 voting par...

  4. Effectiveness of computer-assisted interactive videodisc instruction in teaching rheumatology to physical and occupational therapy students.

    Science.gov (United States)

    Sanford, M K; Hazelwood, S E; Bridges, A J; Cutts, J H; Mitchell, J A; Reid, J C; Sharp, G

    1996-01-01

    A computer-assisted interactive videodisc instructional program, HP-RHEUM was designed to teach clinical findings in arthritis to occupational and physical therapy students. Using the Rheumatology Image Library videodisc produced by the National Library of Medicine, HP-RHEUM consists of instructional modules which employ advance organizers, examples/nonexamples, summaries, and immediate feedback. To see if HP-RHEUM would be as effective as traditional classroom instruction, control data were collected in 1991 from 52 OT and PT students. Treatment data were collected from 61 students in 1992 when HP-RHEUM entirely replaced lectures. Identical pre- and post-tests consisted of 70 multiple choice questions, with 24 matched to slides. On the slide questions the HP-RHEUM group had significantly higher scores. Otherwise, there was no significant difference in performance between groups. HP-RHEUM provided an independent learning method and enhanced visual comprehension of rheumatologic disease concepts.

  5. Demyelinizing neurological disease after treatment with tumor necrosis factor alpha-inhibiting agents in a rheumatological outpatient clinic

    DEFF Research Database (Denmark)

    Theibich, Ali; Dreyer, Lene; Magyari, Melinda

    2014-01-01

    Biological treatment with inhibitors of the pro-inflammatory cytokine TNF-alpha has dramatically improved the disease course of several chronic rheumatologic conditions. Adverse events (AEs) are primarily infections and hypersensitivity reactions. Demyelinizing neurological symptoms resembling...... multiple sclerosis (MS) have been described as a rare AE. During about 10-year use of anti TNF-alpha, the Danish Medicines Agency has recorded eight cases of MS like AEs. The objective of this study was to estimate the incidence of demyelinizing AEs both in the central and peripheral nervous system after...... treatment with anti TNF-alpha in a cohort of patients from a large rheumatologic outpatient clinic in Copenhagen. In a 4-year period from January 2008 to December 2011, approximately 550 patients annually were undergoing treatment with anti TNF-alpha inhibitors in our department. We collected data on all...

  6. Relationship between damage clustering and mortality in systemic lupus erythematosus in early and late stages of the disease: cluster analyses in a large cohort from the Spanish Society of Rheumatology Lupus Registry.

    Science.gov (United States)

    Pego-Reigosa, José María; Lois-Iglesias, Ana; Rúa-Figueroa, Íñigo; Galindo, María; Calvo-Alén, Jaime; de Uña-Álvarez, Jacobo; Balboa-Barreiro, Vanessa; Ibáñez Ruan, Jesús; Olivé, Alejandro; Rodríguez-Gómez, Manuel; Fernández Nebro, Antonio; Andrés, Mariano; Erausquin, Celia; Tomero, Eva; Horcada Rubio, Loreto; Uriarte Isacelaya, Esther; Freire, Mercedes; Montilla, Carlos; Sánchez-Atrio, Ana I; Santos-Soler, Gregorio; Zea, Antonio; Díez, Elvira; Narváez, Javier; Blanco-Alonso, Ricardo; Silva-Fernández, Lucía; Ruiz-Lucea, María Esther; Fernández-Castro, Mónica; Hernández-Beriain, José Ángel; Gantes-Mora, Marian; Hernández-Cruz, Blanca; Pérez-Venegas, José; Pecondón-Español, Ángela; Marras Fernández-Cid, Carlos; Ibáñez-Barcelo, Mónica; Bonilla, Gema; Torrente-Segarra, Vicenç; Castellví, Iván; Alegre, Juan José; Calvet, Joan; Marenco de la Fuente, José Luis; Raya, Enrique; Vázquez-Rodríguez, Tomás Ramón; Quevedo-Vila, Víctor; Muñoz-Fernández, Santiago; Otón, Teresa; Rahman, Anisur; López-Longo, Francisco Javier

    2016-07-01

    To identify patterns (clusters) of damage manifestations within a large cohort of SLE patients and evaluate the potential association of these clusters with a higher risk of mortality. This is a multicentre, descriptive, cross-sectional study of a cohort of 3656 SLE patients from the Spanish Society of Rheumatology Lupus Registry. Organ damage was ascertained using the Systemic Lupus International Collaborating Clinics Damage Index. Using cluster analysis, groups of patients with similar patterns of damage manifestations were identified. Then, overall clusters were compared as well as the subgroup of patients within every cluster with disease duration shorter than 5 years. Three damage clusters were identified. Cluster 1 (80.6% of patients) presented a lower amount of individuals with damage (23.2 vs 100% in clusters 2 and 3, P Cluster 2 (11.4% of patients) was characterized by musculoskeletal damage in all patients. Cluster 3 (8.0% of patients) was the only group with cardiovascular damage, and this was present in all patients. The overall mortality rate of patients in clusters 2 and 3 was higher than that in cluster 1 (P clusters. Both in early and late stages of the disease, there was a significant association of these clusters with an increased risk of mortality. Physicians should pay special attention to the early prevention of damage in these two systems. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  7. Cost of common low back pain and lumbar radiculopathy in rheumatologic consultation in Lomé.

    Science.gov (United States)

    Fianyo, Eyram; Oniankitan, Owonayo; Tagbor Komi, C; Kakpovi, Kodjo; Houzou, Prénam; Koffi-Tessio Viwalé, E S; Mijiyawa, Moustafa

    2017-03-01

    The cost of low back pain was the subject of few studies in black Africa. To assess the cost of common low back pain and lumbar radiculopathy in Lomé. A six months study was realised in the rheumatologic department of CHU Sylvanus Olympio. 103 consecutive patients suffering from a common low back pain or lumbar radiculopathy were included. To assess direct, indirect and non-financial costs they were questioned about their expense during the year. Financial cost of common low back pain and lumbar radiculopathy amounted to 107.2 $ US (extremes: 5.8 and 726.1 $ US). This amount, quadruple of guaranteed minimum wage, felled under two headings: direct cost (56.3 $ US; 53% of total sum), indirect cost (50.3 $ US; 47% of total sum). Non-financial cost were: disruption in daily activities (94%), impact in emotional and sexual life (59%), impact on the family's budget (69%), abandon of family's projects (58%) or of leisure (42%). In black Africa top priority is given to the fight against infectious diseases those cause an important mortality. But common low back pain and lumbar radiculopathy, those have social and economic impact, should be given more attention.

  8. Italian Society for Rheumatology recommendations for the management of hand osteoarthritis

    Directory of Open Access Journals (Sweden)

    M. Manara

    2013-10-01

    Full Text Available Hand osteoarthritis (OA is a common and potentially disabling disease, with different features from hip and knee OA so that a specific therapeutic approach is required. Evidence based recommendations for the management of hand OA were developed by the European League Against Rheumatism (EULAR in 2006. The Italian Society for Rheumatology (SIR aimed to update, adapt to national contest and disseminate the EULAR recommendations for the management of hand OA. The multidisciplinary group of experts included specialists involved in the management of patients with hand OA. In order to maintain consistency with EULAR recommendations, a similar methodology was utilized by the Italian group. The original propositions were reformulated in terms of a search query and for every recommendation a systematic search was conducted updating EULAR recommendations’ review. The propositions were translated in Italian and reformulated basing on collected evidences and expert opinion. The strength of recommendation was measured for each proposition with the EULAR ordinal and visual analogue scales. The original 11 propositions of EULAR recommendations were translated and adapted to Italian context. Further evidences were collected about non-pharmacological therapies, local treatments, intra-articular injection with SYSADOA and corticosteroids, and surgery. The SIR has developed updated recommendations for the management of hand OA adapted to the Italian healthcare system. Their implementation in clinical practice is expected to improve the management of patients with hand OA.

  9. Redesign of the Attention Process of Patients with Rheumatologic Diseases: Assessing the Performance with Analytic Hierarchy Process

    OpenAIRE

    Gorbanev, Iouri; Cortes, Ariel; Agudelo-Londoño, Sandra

    2017-01-01

    Objective. To compare the Business process management and the analytic hierarchy process as the tools of process performance assessment. Instruments and Methods. Case study of the attention process of rheumatology patients. Business process management and analytic hierarchy process were applied to assess the redesign of the attention process. The two methods were compared. The data were obtained through personal observations, an interview with a Colombian health insurer’s senior executive, an...

  10. A survey of anatomical items relevant to the practice of rheumatology: upper extremity, head, neck, spine, and general concepts.

    Science.gov (United States)

    Villaseñor-Ovies, Pablo; Navarro-Zarza, José Eduardo; Saavedra, Miguel Ángel; Hernández-Díaz, Cristina; Canoso, Juan J; Biundo, Joseph J; Kalish, Robert A; de Toro Santos, Francisco Javier; McGonagle, Dennis; Carette, Simon; Alvarez-Nemegyei, José

    2016-12-01

    This study aimed to identify the anatomical items of the upper extremity and spine that are potentially relevant to the practice of rheumatology. Ten rheumatologists interested in clinical anatomy who published, taught, and/or participated as active members of Clinical Anatomy Interest groups (six seniors, four juniors), participated in a one-round relevance Delphi exercise. An initial, 560-item list that included 45 (8.0 %) general concepts items; 138 (24.8 %) hand items; 100 (17.8 %) forearm and elbow items; 147 (26.2 %) shoulder items; and 130 (23.2 %) head, neck, and spine items was compiled by 5 of the participants. Each item was graded for importance with a Likert scale from 1 (not important) to 5 (very important). Thus, scores could range from 10 (1 × 10) to 50 (5 × 10). An item score of ≥40 was considered most relevant to competent practice as a rheumatologist. Mean item Likert scores ranged from 2.2 ± 0.5 to 4.6 ± 0.7. A total of 115 (20.5 %) of the 560 initial items reached relevance. Broken down by categories, this final relevant item list was composed by 7 (6.1 %) general concepts items; 32 (27.8 %) hand items; 20 (17.4 %) forearm and elbow items; 33 (28.7 %) shoulder items; and 23 (17.6 %) head, neck, and spine items. In this Delphi exercise, a group of practicing academic rheumatologists with an interest in clinical anatomy compiled a list of anatomical items that were deemed important to the practice of rheumatology. We suggest these items be considered curricular priorities when training rheumatology fellows in clinical anatomy skills and in programs of continuing rheumatology education.

  11. Person-centred care in nurse-led outpatient rheumatology clinics: Conceptualization and initial development of a measurement instrument.

    Science.gov (United States)

    Bala, Sidona-Valentina; Forslind, Kristina; Fridlund, Bengt; Samuelson, Karin; Svensson, Björn; Hagell, Peter

    2018-06-01

    Person-centred care (PCC) is considered a key component of effective illness management and high-quality care. However, the PCC concept is underdeveloped in outpatient care. In rheumatology, PCC is considered an unmet need and its further development and evaluation is of high priority. The aim of the present study was to conceptualize and operationalize PCC, in order to develop an instrument for measuring patient-perceived PCC in nurse-led outpatient rheumatology clinics. A conceptual outpatient PCC framework was developed, based on the experiences of people with rheumatoid arthritis (RA), person-centredness principles and existing PCC frameworks. The resulting framework was operationalized into the PCC instrument for outpatient care in rheumatology (PCCoc/rheum), which was tested for acceptability and content validity among 50 individuals with RA attending a nurse-led outpatient clinic. The conceptual framework focuses on the meeting between the person with RA and the nurse, and comprises five interrelated domains: social environment, personalization, shared decision-making, empowerment and communication. Operationalization of the domains into a pool of items generated a preliminary PCCoc/rheum version, which was completed in a mean (standard deviation) of 5.3 (2.5) min. Respondents found items easy to understand (77%) and relevant (93%). The Content Validity Index of the PCCoc/rheum was 0.94 (item level range, 0.87-1.0). About 80% of respondents considered some items redundant. Based on these results, the PCCoc/rheum was revised into a 24-item questionnaire. A conceptual outpatient PCC framework and a 24-item questionnaire intended to measure PCC in nurse-led outpatient rheumatology clinics were developed. The extent to which the questionnaire represents a measurement instrument remains to be tested. Copyright © 2018 John Wiley & Sons, Ltd.

  12. Improving the peer review skills of young rheumatologists and researchers in rheumatology: the EMEUNET Peer Review Mentoring Program.

    Science.gov (United States)

    Rodríguez-Carrio, Javier; Putrik, Polina; Sepriano, Alexandre; Moltó, Anna; Nikiphorou, Elena; Gossec, Laure; Kvien, Tore K; Ramiro, Sofia

    2018-01-01

    Although peer review plays a central role in the maintenance of high standards in scientific research, training of reviewing skills is not included in the common education programmes. The Emerging EULAR (European League Against Rheumatism) Network (EMEUNET) developed a programme to address this unmet need. The EMEUNET Peer Review Mentoring Program for Rheumatology Journals promotes a systematic training of reviewing skills by engaging mentees in a 'real world' peer review experience supervised by experienced mentors with support from rheumatology journals. This viewpoint provides an overview of this initiative and its outcomes, and discusses its potential limitations. Over 4 years, 18 mentors and 86 mentees have participated. Among the 33 participants who have completed the programme, 13 (39.3%) have become independent reviewers for Annals of the Rheumatic Diseases after the training. This programme has been recently evaluated by a survey and qualitative interviews, revealing a high interest in this initiative. The main strengths (involvement of a top journal and learning opportunities) and weaknesses of the programme (limited number of places and insufficient dissemination) were identified. Overall, this programme represents an innovative and successful approach to peer review training. Continuous evaluation and improvement are key to its functioning. The EMEUNET Peer Review Mentoring Program may be used as a reference for peer review training in areas outside rheumatology.

  13. Pros and cons of conjoint analysis of discrete choice experiments to define classification and response criteria in rheumatology.

    Science.gov (United States)

    Taylor, William J

    2016-03-01

    Conjoint analysis of choice or preference data has been used in marketing for over 40 years but has appeared in healthcare settings much more recently. It may be a useful technique for applications within the rheumatology field. Conjoint analysis in rheumatology contexts has mainly used the approaches implemented in 1000Minds Ltd, Dunedin, New Zealand, Sawtooth Software, Orem UT, USA. Examples include classification criteria, composite response criteria, service prioritization tools and utilities assessment. Limitations imposed by very many attributes can be managed using new techniques. Conjoint analysis studies of classification and response criteria suggest that the assumption of equal weighting of attributes cannot be met, which challenges traditional approaches to composite criteria construction. Weights elicited through choice experiments with experts can derive more accurate classification criteria, than unweighted criteria. Studies that find significant variation in attribute weights for composite response criteria for gout make construction of such criteria problematic. Better understanding of various multiattribute phenomena is likely to increase with increased use of conjoint analysis, especially when the attributes concern individual perceptions or opinions. In addition to classification criteria, some applications for conjoint analysis that are emerging in rheumatology include prioritization tools, remission criteria, and utilities for life areas.

  14. Baseline demographic characteristics of subjects enrolled in international quadrivalent HPV (types 6/11/16/18) vaccine clinical trials.

    Science.gov (United States)

    Paavonen, Jorma

    2008-06-01

    In Phase II/III trials, administration of quadrivalent human papillomavirus (HPV) (types 6/11/16/18) L1 virus-like-particle vaccine was highly effective in preventing HPV6/11/16/18-related cervical intraepithelial neoplasia and non-invasive cervical cancer in women aged 16-26 years who were naïve to these HPV types at enrollment. However, the makeup and extent of catch-up vaccination programs among young women is unclear, because a proportion of this population will likely already have been exposed to one or more vaccine-HPV-types. Herein we analyze baseline data from the quadrivalent HPV vaccine clinical trial program to investigate variables which may help shape catch-up vaccine implementation policies. Female adolescents and young adults aged 16-26 years were randomized into five clinical trials. Baseline data regarding demographics, sexual history, pregnancy history, and other characteristics were collected at enrollment. At the baseline gynecological examination during enrollment, specimens were obtained for Pap testing. Swabs of external genital, lateral vaginal, and cervical sites for HPV polymerase chain reaction (PCR) testing were taken, and serum samples were obtained for HPV serology testing. Regional analyses of data were conducted. Overall, 72% of subjects enrolled worldwide were naïve by both serology and PCR to all four vaccine HPV types. Few subjects were seropositive and/or PCR positive for more than two vaccine-related HPV types. Of all subjects with HSIL at enrollment, 78% were positive to at least one vaccine-related HPV type at enrollment. Regional differences in HPV and STD prevalence were evident. Study limitations included under-representation of women with >/=4 sexual partners and possible underestimation of prior HPV exposure. Our findings demonstrate that sexually active 16-26 year-old women with America, Europe, Latin America, and Asia Pacific are generally naïve to most or all types targeted by the quadrivalent HPV6/11/16/18 vaccine

  15. Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT) protocol: a pragmatic multi-centre randomised controlled trial of cast treatment versus surgical fixation for the treatment of bi-cortical, minimally displaced fractures of the scaphoid waist in adults.

    Science.gov (United States)

    Dias, Joseph; Brealey, Stephen; Choudhary, Surabhi; Cook, Liz; Costa, Matthew; Fairhurst, Caroline; Hewitt, Catherine; Hodgson, Stephen; Jefferson, Laura; Jeyapalan, Kanagaratnam; Keding, Ada; Leighton, Paul; Rangan, Amar; Richardson, Gerry; Rothery, Claire; Taub, Nicholas; Thompson, John; Torgerson, David

    2016-06-04

    this. The SWIFFT Trial is a rigorously designed and adequately powered study which aims to contribute to the evidence-base to inform clinical decisions for the treatment of this common fracture in adults. The trial is registered with the International Standard Randomised Controlled Trial Register ( ISRCTN67901257 ). Date registration assigned was 13/02/2013.

  16. The effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized clinical trial.

    NARCIS (Netherlands)

    Baar, M.E. van; Dekker, J.; Oostendorp, R.A.B.; Bijl, D.; Voorn, T.B.; Lemmens, J.A.M.; Bijlsma, J.W.J.

    1998-01-01

    Objective: To determine the effectiveness of exercise therapy in patients with osteoarthritis (OA) of the hip or knee. Methods: A randomized single blind, clinical trial was conducted in a primary care setting. Patients with hip or knee OA by American College of Rheumatology criteria were

  17. The effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized clinical trial

    NARCIS (Netherlands)

    van Baar, M. E.; Dekker, J.; Oostendorp, R. A.; Bijl, D.; Voorn, T. B.; Lemmens, J. A.; Bijlsma, J. W.

    1998-01-01

    To determine the effectiveness of exercise therapy in patients with osteoarthritis (OA) of the hip or knee. A randomized single blind, clinical trial was conducted in a primary care setting. Patients with hip or knee OA by American College of Rheumatology criteria were selected. Two intervention

  18. Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): an international, double-blind, randomised placebo-controlled trial.

    Science.gov (United States)

    Cuzick, Jack; Sestak, Ivana; Forbes, John F; Dowsett, Mitch; Knox, Jill; Cawthorn, Simon; Saunders, Christobel; Roche, Nicola; Mansel, Robert E; von Minckwitz, Gunter; Bonanni, Bernardo; Palva, Tiina; Howell, Anthony

    2014-03-22

    Aromatase inhibitors effectively prevent breast cancer recurrence and development of new contralateral tumours in postmenopausal women. We assessed the efficacy and safety of the aromatase inhibitor anastrozole for prevention of breast cancer in postmenopausal women who are at high risk of the disease. Between Feb 2, 2003, and Jan 31, 2012, we recruited postmenopausal women aged 40-70 years from 18 countries into an international, double-blind, randomised placebo-controlled trial. To be eligible, women had to be at increased risk of breast cancer (judged on the basis of specific criteria). Eligible women were randomly assigned (1:1) by central computer allocation to receive 1 mg oral anastrozole or matching placebo every day for 5 years. Randomisation was stratified by country and was done with blocks (size six, eight, or ten). All trial personnel, participants, and clinicians were masked to treatment allocation; only the trial statistician was unmasked. The primary endpoint was histologically confirmed breast cancer (invasive cancers or non-invasive ductal carcinoma in situ). Analyses were done by intention to treat. This trial is registered, number ISRCTN31488319. 1920 women were randomly assigned to receive anastrozole and 1944 to placebo. After a median follow-up of 5·0 years (IQR 3·0-7·1), 40 women in the anastrozole group (2%) and 85 in the placebo group (4%) had developed breast cancer (hazard ratio 0·47, 95% CI 0·32-0·68, pbreast cancers after 7 years was 5·6% in the placebo group and 2·8% in the anastrozole group. 18 deaths were reported in the anastrozole group and 17 in the placebo group, and no specific causes were more common in one group than the other (p=0·836). Anastrozole effectively reduces incidence of breast cancer in high-risk postmenopausal women. This finding, along with the fact that most of the side-effects associated with oestrogen deprivation were not attributable to treatment, provides support for the use of anastrozole in

  19. Medication use in juvenile uveitis patients enrolled in the Childhood Arthritis and Rheumatology Research Alliance Registry.

    Science.gov (United States)

    Henderson, Lauren A; Zurakowski, David; Angeles-Han, Sheila T; Lasky, Andrew; Rabinovich, C Egla; Lo, Mindy S

    2016-02-16

    There is not yet a commonly accepted, standardized approach in the treatment of juvenile idiopathic uveitis when initial steroid therapy is insufficient. We sought to assess current practice patterns within a large cohort of children with juvenile uveitis. This is a cross-sectional cohort study of patients with uveitis enrolled in the Childhood Arthritis and Rheumatology Research Alliance (CARRAnet) registry. Clinical information including, demographic information, presenting features, disease complications, and medications were collected. Chi-square and Fisher's exact tests were used to assess for associations between medications and clinical characteristics. Ninety-two children with idiopathic and 656 with juvenile idiopathic arthritis (JIA)-associated uveitis were identified. Indication (arthritis or uveitis) for medication use was not available for JIA patients; therefore, detailed analysis was limited to children with idiopathic uveitis. In this group, 94 % had received systemic steroids. Methotrexate (MTX) was used in 76 % of patients, with oral and subcutaneous forms given at similar rates. In multivariable analysis, non-Caucasians were more likely to be treated initially with subcutaneous MTX (P = 0.003). Of the 53 % of patients treated with a biologic DMARD, all received a tumor necrosis factor (TNF) inhibitor. TNF inhibitor use was associated with a higher frequency of cataracts (52 % vs 21 %; P = 0.001) and antinuclear antibody positivity (49 % vs 29 %; P = 0.04), although overall complication rates were not higher in these patients. Among idiopathic uveitis patients enrolled in the CARRAnet registry, MTX was the most commonly used DMARD, with subcutaneous and oral forms equally favored. Patients who received a TNF inhibitor were more likely to be ANA positive and have cataracts.

  20. 2012 Brazilian Society of Rheumatology Consensus for the treatment of rheumatoid arthritis.

    Science.gov (United States)

    da Mota, Licia Maria Henrique; Cruz, Boris Afonso; Brenol, Claiton Viegas; Pereira, Ivanio Alves; Rezende-Fronza, Lucila Stange; Bertolo, Manoel Barros; de Freitas, Max Victor Carioca; da Silva, Nilzio Antonio; Louzada-Júnior, Paulo; Giorgi, Rina Dalva Neubarth; Lima, Rodrigo Aires Corrêa; da Rocha Castelar Pinheiro, Geraldo

    2012-01-01

    To elaborate recommendations for the treatment of rheumatoid arthritis in Brazil. Literature review with articles' selection based on evidence and the expert opinion of the Rheumatoid Arthritis Committee of the Brazilian Society of Rheumatology. 1) The therapeutic decision should be shared with the patient; 2) immediately after the diagnosis, a disease-modifying antirheumatic drug (DMARD) should be prescribed, and the treatment adjusted to achieve remission; 3) treatment should be conducted by a rheumatologist; 4) the initial treatment includes synthetic DMARDs; 5) methotrexate is the drug of choice; 6) patients who fail to respond after two schedules of synthetic DMARDs should be assessed for the use of biologic DMARDs; 7) exceptionally, biologic DMARDs can be considered earlier; 8) anti-TNF agents are preferentially recommended as the initial biologic therapy; 9) after therapeutic failure of a first biologic DMARD, other biologics can be used; 10) cyclophosphamide and azathioprine can be used in severe extra-articular manifestations; 11) oral corticoid is recommended at low doses and for short periods of time; 12) non-steroidal anti-inflammatory drugs should always be prescribed in association with a DMARD; 13) clinical assessments should be performed on a monthly basis at the beginning of treatment; 14) physical therapy, rehabilitation, and occupational therapy are indicated; 15) surgical treatment is recommended to correct sequelae; 16) alternative therapy does not replace traditional therapy; 17) family planning is recommended; 18) the active search and management of comorbidities are recommended; 19) the patient's vaccination status should be recorded and updated; 20) endemic-epidemic transmissible diseases should be investigated and treated.

  1. A system of networks and continuing education for physical therapists in rheumatology: a feasibility study

    Directory of Open Access Journals (Sweden)

    J. Verhoef

    2004-07-01

    Full Text Available Purpose: To evaluate the feasibility of regional physical therapy networks including continuing education in rheumatology. The aim of these networks was to improve care provided by primary care physical therapists by improving specific knowledge, technical and communicative skills and the collaboration with rheumatologists. Methods: In two regions in The Netherlands continuing education (CE programmes, consisting of a 5-day postgraduate training course followed by bimonthly workshops and teaching practices, were organised simultaneously. Network activities included consultations, newsletters and the development of a communication guideline. Endpoint measures included the participation rate, compliance, quality of the CE programme, teaching practices, knowledge, network activities, communication, number of patients treated and patient satisfaction. Results: Sixty-three physical therapists out of 193 practices (33% participated in the project. They all completed the education programmes and were formally registered. All evaluations of the education programmes showed positive scores. Knowledge scores increased significantly directly after the training course and at 18 months. A draft guideline on communication between physical therapists and rheumatologists was developed, and 4 newsletters were distributed. A substantial proportion of physical therapists and rheumatologists reported improved communication at 18 months. The mean number of patients treated by physical therapists participating in the networks increased significantly. Patients' satisfaction scores within the networks were significantly higher than those from outside the networks at 18 months. Conclusions: Setting up a system of networks for continuing education for physical therapists regarding the treatment of patients with rheumatic diseases is feasible. Further research will focus on the effectiveness of the system and its implementation on a larger scale.

  2. Manifestaciones reumatológicas de la enfermedad inflamatoria intestinal Rheumatologic manifestations of inflammatory bowel disease

    Directory of Open Access Journals (Sweden)

    Octavio Germán Muñoz Maya

    2006-01-01

    Full Text Available La enfermedad inflamatoria intestinal (EII se caracteriza por la activación inapropiada del sistema inmune de la mucosa intestinal y sus dos formas de presentación son: la colitis ulcerativa y la enfermedad de Crohn. Las manifestaciones extraintestinales se presentan hasta en el 36% de los pacientes y pueden comprometer cualquier órgano o sistema. La disfunción inmune se caracteriza por el desequilibrio entre los mediadores proinflamatorios y los antinflamatorios y se expresa como una enfermedad sistémica. Las manifestaciones reumatológicas asociadas a la EII son de tres tipos: la artritis periférica, la espondiloartropatía y una tercera categoría que incluye lesiones dérmicas, oftálmicas y del metabolismo óseo, entre otras. El manejo de estas manifestaciones se basa en la terapia sistémica para el control de la actividad inflamatoria local utilizando esteroides, derivados de la 5-ASA, inmunomoduladores y, en los últimos años, terapia anti-TNF. The main feature of inflammatory bowel disease (IBD is the continuous activation of the mucosa-associated immune system; the disease has two major forms of presentation: ulcerative colitis and Crohn´s disease. The extraintestinal manifestations are present in 36% of patients, and any organ can be affected. There is an imbalance between proinflammatory and antinflammatory cytokines leading to a systemic disease. The rheumatologic manifestations of the IBD are: Peripheral arthritis, spondyloarthropathy and a third category that includes dermic and ocular lesions as well as metabolic bone disease. Control of the extraintestinal manifestations is based on systemic therapy with steroids, 5-ASA derivatives and biological anti-TNF therapy.

  3. Survival and human papillomavirus in oropharynx cancer in TAX 324: a subset analysis from an international phase III trial.

    Science.gov (United States)

    Posner, M R; Lorch, J H; Goloubeva, O; Tan, M; Schumaker, L M; Sarlis, N J; Haddad, R I; Cullen, K J

    2011-05-01

    The association between human papillomavirus (HPV) and overall survival (OS) in oropharynx cancer (OPC) was retrospectively examined in TAX 324, a phase III trial of sequential therapy for locally advanced head and neck cancer. Accrual for TAX 324 was completed in 2003 and data updated through 2008. Pretherapy tumor biopsies were studied by PCR for human papillomavirus type 16 and linked to OS, progression-free survival (PFS) and demographics. Of 264 patients with OPC, 111 (42%) had evaluable biopsies; 56 (50%) were HPV+ and 55 (50%) were HPV-. HPV+ patients were significantly younger (54 versus 58 years, P = 0.02), had T1/T2 primary cancers (49% versus 20%, P = 0.001), and had a performance status of zero (77% versus 49%, P = 0.003). OS and PFS were better for HPV+ patients (OS, hazard ratio = 0.20, P < 0.0001). Local-regional failure was less in HPV+ patients (13% versus 42%, P = 0.0006); at 5 years, 82% of HPV+ patients were alive compared with 35% of HPV- patients (P < 0.0001). HPV+ OPC has a different biology compared with HPV- OPC; 5-year OS, PFS, and local-regional control are unprecedented. These results support the possibility of selectively reducing therapy and long-term morbidity in HPV+ OPC while preserving survival and approaching HPV- disease with more aggressive treatment.

  4. Perspectives of family members participating in cultural assessment of psychiatric disorders: findings from the DSM-5 International Field Trial.

    Science.gov (United States)

    Hinton, Ladson; Aggarwal, Neil; Iosif, Ana-Maria; Weiss, Mitchell; Paralikar, Vasudeo; Deshpande, Smita; Jadhav, Sushrut; Ndetei, David; Nicasio, Andel; Boiler, Marit; Lam, Peter; Avelar, Yesi; Lewis-Fernández, Roberto

    2015-02-01

    Despite the important roles families play in the lives of many individuals with mental illness across cultures, there is a dearth of data worldwide on how family members perceive the process of cultural assessment as well as to how to best include them. This study addresses this gap in our knowledge through analysis of data collected across six countries as part of a DSM-5 Field Trial of the Cultural Formulation Interview (CFI). At clinician discretion, individuals who accompanied patients to the clinic visit (i.e. patient companions) at the time the CFI was conducted were invited to participate in the cultural assessment and answer questions about their experience. The specific aims of this paper are (1) to describe patterns of participation of patient companions in the CFI across the six countries, and (2) to examine the comparative feasibility, acceptability, and clinical utility of the CFI from companion perspectives through analysis of both quantitative and qualitative data. Among the 321 patient interviews, only 86 (at four of 12 sites) included companions, all of whom were family members or other relatives. The utility, feasibility and acceptability of the CFI were rated favourably by relatives, supported by qualitative analyses of debriefing interviews. Cross-site differences in frequency of accompaniment merit further study.

  5. Nailfold videocapillaroscopy in internal medicine

    Directory of Open Access Journals (Sweden)

    Paola Faggioli

    2015-09-01

    Full Text Available Capillaroscopy is an actual inexpensive imaging technique, used to examine, non-invasively and safely, the morphology of nailfold dermal papillary capillaries. Many studies agree in the statement that the capillaroscopy is one of the gold standard methods for non-invasive examination of the microcirculation and it plays an important role in screening in Raynaud’s phenomenon and in monitoring of systemic sclerosis and other rheumatologic diseases. There are also many reports on the possible use of nailfold capillaroscopy in the diagnosis and monitoring of many other diseases in internal medicine.

  6. Opening the Internal Hematoma Membrane Does Not Alter the Recurrence Rate of Chronic Subdural Hematomas: A Prospective Randomized Trial.

    Science.gov (United States)

    Unterhofer, Claudia; Freyschlag, Christian F; Thomé, Claudius; Ortler, Martin

    2016-08-01

    Factors determining the recurrence of chronic subdural hematomas (CSDHs) are not clear. Whether opening the so-called internal hematoma membrane is useful has not been investigated. To investigate whether splitting the inner hematoma membrane influences the recurrence rate in patients undergoing burr-hole craniotomy for CSDH. Fifty-two awake patients undergoing surgery for 57 CSDHs were prospectively randomized to either partial opening of the inner hematoma membrane (group A) or not (group B) after enlarged burr-hole craniotomy and hematoma evacuation. Drainage was left in situ for several days postoperatively. Groups were comparable with regard to demographic, clinical, and imaging variables. Outcome was assessed after 3-6 weeks for the combined outcome variable of reoperation or residual hematoma of one third or more of the original hematoma thickness. Fourteen patients underwent reoperation for clinical deterioration or residual hematoma during follow-up (n = 6 in group A, 21%; n = 8 in group B, 28 %) (P = 0.537). Residual hematoma of ≥ one third not requiring surgery was present in 7 patients in group A (25%) and 10 patients in group B (36%) (P = 0.383). The overall cumulative failure rate (reoperation or hematoma thickness ≥ one third) was 13/28 (46%) in group A and 18/28 in group B (P = 0.178; relative risk, 0.722 [95% confidence interval, 0.445-1.172]; absolute risk reduction -16% [95% confidence interval, -38% to 8%]). Opening the internal hematoma membrane does not alter the rate of patients requiring revision surgery and the number of patients showing a marked residual hematoma 6 weeks after evacuation of a CSDH. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Vismodegib in patients with advanced basal cell carcinoma: Primary analysis of STEVIE, an international, open-label trial.

    Science.gov (United States)

    Basset-Séguin, N; Hauschild, A; Kunstfeld, R; Grob, J; Dréno, B; Mortier, L; Ascierto, P A; Licitra, L; Dutriaux, C; Thomas, L; Meyer, N; Guillot, B; Dummer, R; Arenberger, P; Fife, K; Raimundo, A; Dika, E; Dimier, N; Fittipaldo, A; Xynos, I; Hansson, J

    2017-11-01

    The SafeTy Events in VIsmodEgib study (STEVIE, ClinicalTrials.gov, NCT01367665), assessed safety and efficacy of vismodegib-a first-in-class Hedgehog pathway inhibitor demonstrating clinical benefit in advanced basal cell carcinoma (BCC)-in a patient population representative of clinical practice. Primary analysis data are presented. Patients with locally advanced or metastatic BCC received oral vismodegib 150 mg/d until progressive disease, unacceptable toxicity, or withdrawal. Primary objective was safety. Efficacy variables were assessed as secondary end-points. Evaluable adult patients (N = 1215, 1119 locally advanced; 96 metastatic BCC) from 36 countries were treated; 147 patients (12%) remained on study at time of reporting. Median (range) treatment duration was 8.6 (0-44) months. Most patients (98%) had ≥1 treatment-emergent adverse event (TEAE). The incidence of the most common TEAEs was consistent with reports in previous analyses. No association between creatine phosphokinase (CPK) abnormalities and muscle spasm was observed. Serious TEAEs occurred in 289 patients (23.8%). Exposure ≥12 months did not lead to increased incidence or severity of new TEAEs. The majority of the most common TEAEs ongoing at time of treatment discontinuation resolved by 12 months afterwards, regardless of Gorlin syndrome status. Response rates (investigator-assessed) in patients with histologically confirmed measurable baseline disease were 68.5% (95% confidence interval (CI) 65.7-71.3) in patients with locally advanced BCC and 36.9% (95% CI 26.6-48.1) in patients with metastatic BCC. The primary analysis of STEVIE demonstrates that vismodegib is tolerable in typical patients in clinical practice; safety profile is consistent with that in previous reports. Long-term exposure was not associated with worsening severity/frequency of TEAEs. Investigator-assessed response rates showed high rate of tumour control. CLINICALTRIALS.GOV: NCT01367665. Copyright © 2017 The Authors

  8. International open trial of uniform multidrug therapy regimen for leprosy patients: Findings & implications for national leprosy programmes.

    Science.gov (United States)

    Manickam, Ponnaiah; Mehendale, Sanjay M; Nagaraju, Bathyala; Katoch, Kiran; Jamesh, Abdul; Kutaiyan, Ramalingam; Jianping, Shen; Mugudalabetta, Shivakumar; Jadhav, Vitthal; Rajkumar, Prabu; Padma, Jayasree; Kaliaperumal, Kanagasabai; Pannikar, Vijayakumar; Krishnamurthy, Padabettu; Gupte, Mohan D

    2016-10-01

    Uniform therapy for all leprosy patients will simplify leprosy treatment. In this context, we evaluated six-month multidrug therapy (MDT) currently recommended for multibacillary (MB) patients as uniform MDT (U-MDT) in a single-arm open trial under programme conditions. Primary objective was to determine efficacy to prevent five-year cumulative five per cent relapse. Secondary objectives were to assess acceptability, safety and compliance. Newly detected, treatment-naive leprosy patients were enrolled in India (six sites) and P. R. China (two sites). Primary outcome was clinically confirmed relapse of occurrence of one or more new skin patches consistent with leprosy, without evidence of reactions post-treatment. Event rates per 100 person years as well as five-year cumulative risk of relapse, were calculated. A total of 2091 paucibacillary (PB) and 1298 MB leprosy patients were recruited from the 3437 patients screened. Among PB, two relapsed (rate=0.023; risk=0.11%), eight had suspected adverse drug reactions (ADRs) (rate=0.79) and rate of new lesions due toreactions was 0.24 (n=23). Rates of neuritis, type 1 and type 2 reactions were 0.39 (n=37), 0.54 (n=51) and 0.03 (n=3), respectively. Among MB, four relapsed (rate=0.07; risk=0.37%) and 16 had suspected ADR (rate=2.64). Rate of new lesions due to reactions among MB was 1.34 (n=76) and rates of neuritis, type 1 and type 2 reactions were 1.37 (n=78), 2.01 (n=114) and 0.49 (n=28), respectively. Compliance to U-MDT was 99 per cent. Skin pigmentation due to clofazimine was of short duration and acceptable. We observed low relapse, minimal ADR and other adverse clinical events. Clofazimine-related pigmentation was acceptable. Evidence supports introduction of U-MDT in national leprosy programmes. [CTRI No: 2012/ 05/ 002696].

  9. New-generation atrial antitachycardia pacing (Reactive ATP) is associated with reduced risk of persistent or permanent atrial fibrillation in patients with bradycardia: Results from the MINERVA randomized multicenter international trial

    NARCIS (Netherlands)

    L. Padeletti (Luigi); H. Pürerfellner (Helmut); L. Mont (Lluis); R. Tukkie (Raymond); A.S. Manolis (Antonis S.); R. Ricci (Renato); G. Inama (Giuseppe); P. Serra (Paolo); M.G. Scheffer (Michael); V. Martins (Vitor); E.N. Warman (Eduardo N.); M. Vimercati (Marco); A. Grammatico (Andrea); G. Boriani

    2015-01-01

    textabstractBackground Atrial fibrillation (AF) is a frequent comorbidity in patients with pacemaker and is a recognized cause of mortality, morbidity, and quality-of-life impairment. The international MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure trial

  10. Can rheumatoid arthritis (RA) registries provide contextual safety data for modern RA clinical trials? The case for mortality and cardiovascular disease.

    Science.gov (United States)

    Michaud, Kaleb; Berglind, Niklas; Franzén, Stefan; Frisell, Thomas; Garwood, Christopher; Greenberg, Jeffrey D; Ho, Meilien; Holmqvist, Marie; Horne, Laura; Inoue, Eisuke; Nyberg, Fredrik; Pappas, Dimitrios A; Reed, George; Symmons, Deborah; Tanaka, Eiichi; Tran, Trung N; Verstappen, Suzanne M M; Wesby-van Swaay, Eveline; Yamanaka, Hisashi; Askling, Johan

    2016-10-01

    We implemented a novel method for providing contextual adverse event rates for a randomised controlled trial (RCT) programme through coordinated analyses of five RA registries, focusing here on cardiovascular disease (CVD) and mortality. Each participating registry (Consortium of Rheumatology Researchers of North America (CORRONA) (USA), Swedish Rheumatology Quality of Care Register (SRR) (Sweden), Norfolk Arthritis Register (NOAR) (UK), CORRONA International (East Europe, Latin America, India) and Institute of Rheumatology, Rheumatoid Arthritis (IORRA) (Japan)) defined a main cohort from January 2000 onwards. To address comparability and potential bias, we harmonised event definitions and defined several subcohorts for sensitivity analyses based on disease activity, treatment, calendar time, duration of follow-up and RCT exclusions. Rates were standardised for age, sex and, in one sensitivity analysis, also HAQ. The combined registry cohorts included 57 251 patients with RA (234 089 person-years)-24.5% men, mean (SD) baseline age 58.2 (13.8) and RA duration 8.2 (11.7) years. Standardised registry mortality rates (per 100 person-years) varied from 0.42 (CORRONA) to 0.80 (NOAR), with 0.60 for RCT patients. Myocardial infarction and major adverse cardiovascular events (MACE) rates ranged from 0.09 and 0.31 (IORRA) to 0.39 and 0.77 (SRR), with RCT rates intermediate (0.18 and 0.42), respectively. Additional subcohort analyses showed small and mostly consistent changes across registries, retaining reasonable consistency in rates across the Western registries. Additional standardisation for HAQ returned higher mortality and MACE registry rates. This coordinated approach to contextualising RA RCT safety data demonstrated reasonable differences and consistency in rates for mortality and CVD across registries, and comparable RCT rates, and may serve as a model method to supplement clinical trial analyses for drug development programmes. Published by the BMJ Publishing

  11. Predictors of bacterial pneumonia in the Evaluation of Subcutaneous Interleukin-2 in a Randomized International Trial (ESPRIT)

    Science.gov (United States)

    Pett, SL; Carey, C; Lin, E; Wentworth, D; Lazovski, J; Miró, JM; Gordin, F; Angus, B; Rodriguez-Barradas, M; Rubio, R; Tambussi, G; Cooper, DA; Emery, S

    2010-01-01

    Background and Objectives Bacterial pneumonia still contributes to morbidity/mortality in HIV-infection despite effective combination antiretroviral therapy (cART). ESPRIT, a trial of intermittent recombinant interleukin-2 (rIL-2) with cART vs.cART alone (control arm) in HIV-infected adults with CD4+≥300 offered the opportunity to explore associations between bacterial pneumonia and rIL-2, a cytokine which increases some bacterial infections. Methods Baseline and time-updated factors associated with first-episode pneumonia on study were analysed using multivariate proportional hazards regression models. Smoking/pneumococcal vaccination history was not collected. Results IL-2 cycling was most intense in years 1-2. Over ≈7 years, 93 IL-2 (rate 0.67/100PY) and 86 control (rate 0.63/100PY) patients experienced a pneumonia-event, (HR=1.06,95%CI=0.79,1.42,p=0.68). Median CD4+ prior to pneumonia was 570 (IL-2 arm) and 463cells/uL (control arm). Baseline risks for bacterial pneumonia included older age, IVDU, detectable HIV viral load (VL), previous recurrent pneumonia; Asian ethnicity was associated with decreased risk. Higher proximal VL (HR for 1 log10 higher VL=1.28,95%CI=1.11,1.47,p=<.001) was associated with increased risk; higher CD4+ prior to the event (HR per 100 cells higher=0.94,95%CI0.89,1.0,p=0.04) decreased risk. Compared to controls, the hazard for a pneumonia-event was higher if rIL-2 was received <180 days prior (HR=1.66,95%CI=1.07,2.60,p=0.02) vs.≥180 days (HR=0.98,95%CI=0.70,1.37,p=0.9). Compared to the control group, pneumonia-risk in the IL-2 arm decreased over time with HRs of 1.41, 1.71, 1.16, 0.62 and 0.84 in years 1, 2, 3-4,5-6 and 7, respectively. Conclusions Bacterial pneumonia rates in cART-treated adults with moderate immunodeficiency are high. The mechanism of the association between bacterial pneumonia and recent IL-2 receipt and/or detectable HIV-viraemia deserves further exploration. PMID:20812949

  12. International Ballroom Dancing Against Neurodegeneration: A Randomized Controlled Trial in Greek Community-Dwelling Elders With Mild Cognitive impairment.

    Science.gov (United States)

    Lazarou, Ioulietta; Parastatidis, Themis; Tsolaki, Anthoula; Gkioka, Mara; Karakostas, Anastasios; Douka, Stella; Tsolaki, Magda

    2017-12-01

    Many studies have highlighted the positive effects of dance in people with neurodegenerative diseases. To explore the effects of International Ballroom Dancing on cognitive function in elders with amnestic mild cognitive impairment (aMCI). One-hundred twenty-nine elderly patients with aMCI diagnosis (mean age 66.8 ± 10.1 years) were randomly assigned into 2 groups: intervention group (IG, n = 66) and control group (CG, n = 63). The IG exercised systematically for 10 months, and both groups were submitted to extensive neuropsychological assessment prior and after the 10-month period. According to the independent sample t test at the follow-up, significant differences between groups were found in benefit of the IG while the CG showed worse performance in the majority of neuropsychological tests. According to the Student t test, better performance is detected in IG in contrast with CG, which had worse performance almost in all scales. Dance may be an important nonpharmacological approach that can benefit cognitive functions.

  13. The impact of dermatology consultation on diagnostic accuracy and antibiotic use among patients with suspected cellulitis seen at outpatient internal medicine offices: a randomized clinical trial.

    Science.gov (United States)

    Arakaki, Ryan Y; Strazzula, Lauren; Woo, Elaine; Kroshinsky, Daniela

    2014-10-01

    Cellulitis is a common and costly problem, often diagnosed in the outpatient setting. Many cutaneous conditions may clinically mimic cellulitis, but little research has been done to assess the magnitude of the problem. To determine if obtaining dermatology consultations in the outpatient primary care setting could assist in the diagnosis of pseudocellulitic conditions and reduce the rate of unnecessary antibiotic use. Nonblinded randomized clinical trial of competent adults who were diagnosed as having cellulitis by their primary care physicians (PCPs), conducted at outpatient internal medical primary care offices affiliated with a large academic medical center. Outpatient dermatology consultation. Primary outcomes were final diagnosis, antibiotic use, and need for hospitalization. A total of 29 patients (12 male and 17 female) were enrolled for participation in this trial. Nine patients were randomized to continue with PCP management (control group), and 20 patients were randomized to receive a dermatology consultation (treatment group). Of the 20 patients in the dermatology consultation group, 2 (10%) were diagnosed as having cellulitis. In the control group, all 9 patients were diagnosed as having cellulitis by PCPs, but dermatologist evaluation determined that 6 (67%) of these patients had a psuedocellulitis rather than true infection. All 9 patients (100%) in the control group were treated for cellulitis with antibiotics vs 2 patients (10%) in the treatment group (P Dermatology consultation in the primary care setting improves the diagnostic accuracy of suspected cellulitis and decreases unnecessary antibiotic use in patients with pseudocellulitic conditions. Obtaining an outpatient dermatology consultation may be a cost-effective strategy that improves quality of care. clinicaltrials.gov Identifier:NCT01795092.

  14. The prevalence of vitamin D deficiency in consecutive new patients seen over a 6-month period in general rheumatology clinics.

    LENUS (Irish Health Repository)

    Haroon, Muhammad

    2012-02-01

    The objectives of this study are to assess: (a) the prevalence of vitamin D deficiency among new patients attending rheumatology outpatient departments, (b) the age profile of these low vitamin D patients and (c) whether any diagnostic category had a particularly high number of vitamin D-deficient patients. All new patients seen consecutively in general rheumatology clinics between January to June 2007 inclusive were eligible to partake in this study, and 231 out of 264 consented to do so. Parathyroid hormone, 25-hydroxyvitamin D, creatinine, calcium, phosphate, albumin and alkaline phosphatase levels were measured. We defined vitamin D deficiency as <\\/=53 nmol\\/l and severe deficiency as <\\/=25 nmol\\/l. Overall, 70% of 231 patients had vitamin D deficiency, and 26% had severe deficiency. Sixty-five percent of patients aged >\\/=65 and 78% of patients aged <\\/=30 years had low vitamin D levels. Vitamin D deficiency in each diagnostic category was as follows: (a) inflammatory joint diseases\\/connective tissue diseases (IJD\\/CTD), 69%; (b) soft tissue rheumatism, 77%; (c) osteoarthritis, 62%; (d) non-specific musculoskeletal back pain, 75% and (e) osteoporosis, 71%. Seasonal variation of vitamin D levels was noted in all diagnostic groups apart from IJD\\/CTD group, where the degree of vitamin D deficiency persisted from late winter to peak summer. Very high prevalence of vitamin D deficiency was noted in all diagnostic categories (p = 0.006), and it was independent of age (p = 0.297). The results suggest vitamin D deficiency as a possible modifiable risk factor in different rheumatologic conditions, and its role in IJD\\/CTD warrants further attention.

  15. Rheumatology in the community of Madrid: current availability of rheumatologists and future needs using a predictive model.

    Science.gov (United States)

    Lázaro y De Mercado, Pablo; Blasco Bravo, Antonio Javier; Lázaro y De Mercado, Ignacio; Castañeda, Santos; López Robledillo, Juan Carlos

    2013-01-01

    To: 1) describe the distribution of the public sector rheumatologists; 2) identify variables on which the workload in Rheumatology depends; and 3) build a predictive model on the need of rheumatologists for the next 10 years, in the Community of Madrid (CM). The information was obtained through structured questionnaires sent to all services/units of Rheumatology of public hospitals in the CM. The population figures, current and forecasted, were obtained from the National Statistics Institute. A predictive model was built based on information about the current and foreseeable supply, current and foreseeable demand, and the assumptions and criteria used to match supply with demand. The underlying uncertainty in the model was assessed by sensitivity analysis. In the CM in 2011 there were 150 staff rheumatologists and 49 residents in 27 centers, which is equivalent to one rheumatologist for every 33,280 inhabitants in the general population, and one for every 4,996 inhabitants over 65 years. To keep the level of assistance of 2011 in 2021 in the general population, it would be necessary to train more residents or hire more rheumatologists in scenarios of demand higher than 15%. However, to keep the level of assistance in the population over 65 years of age it would be necessary to train more residents or hire more specialists even without increased demand. The model developed may be very useful for planning, with the CM policy makers, the needs of human resources in Rheumatology in the coming years. Copyright © 2012 Elsevier España, S.L. All rights reserved.

  16. The effect of new biosimilars in rheumatology and gastroenterology specialities on UK healthcare budgets: Results of a budget impact analysis.

    Science.gov (United States)

    Aladul, Mohammed I; Fitzpatrick, Raymond W; Chapman, Stephen R

    2018-05-15

    The approval of new biosimilars of infliximab, etanercept and adalimumab by the European Medicines Agency is expected to produce further cost savings to the healthcare system budget. This study aimed to estimate the budget impact of the introduction of new biosimilars Flixabi ® , Erelzi ® , Solymbic ® , Amgevita ® and Imraldi ® in rheumatology and gastroenterology specialities in the UK. A published budget impact model was adapted to estimate the expected cost savings following the entry of new biosimilars Flixabi ® , Erelzi ® , Solymbic ® , Amgevita ® and Imraldi ® in the UK over three-year time horizon. This model was based on retrospective market shares of biologics used in rheumatology and gastroenterology which were derived from DEFINE Software and healthcare professional perspectives. The model predicted that infliximab and etanercept biosimilars would replace their corresponding reference agents by 2020. Adalimumab biosimilars were predicted to achieve 19% of the rheumatology and gastroenterology market by 2020. Without the introduction of further biosimilars, the model predicted a reduction in expenditure of £44 million on biologics over the next three years. With the entry of Flixabi ® , Erelzi ® , Solymbic ® , Amgevita ® and Imraldi ® the model estimates cumulative savings of £285 million by 2020. The introduction of new infliximab, etanercept and adalimumab biosimilars will be associated with considerable cost savings and have a substantial favourable impact on the UK NHS budget. The number of biosimilars and time of entry of is critical to create competition which will result in maximum cost savings. Copyright © 2018 Elsevier Inc. All rights reserved.

  17. 2017 American College of Rheumatology/American Association of Hip and Knee Surgeons Guideline for the Perioperative Management of Antirheumatic Medication in Patients With Rheumatic Diseases Undergoing Elective Total Hip or Total Knee Arthroplasty.

    Science.gov (United States)

    Goodman, Susan M; Springer, Bryan; Guyatt, Gordon; Abdel, Matthew P; Dasa, Vinod; George, Michael; Gewurz-Singer, Ora; Giles, Jon T; Johnson, Beverly; Lee, Steve; Mandl, Lisa A; Mont, Michael A; Sculco, Peter; Sporer, Scott; Stryker, Louis; Turgunbaev, Marat; Brause, Barry; Chen, Antonia F; Gililland, Jeremy; Goodman, Mark; Hurley-Rosenblatt, Arlene; Kirou, Kyriakos; Losina, Elena; MacKenzie, Ronald; Michaud, Kaleb; Mikuls, Ted; Russell, Linda; Sah, Alexander; Miller, Amy S; Singh, Jasvinder A; Yates, Adolph

    2017-08-01

    and based on low- or moderate-quality evidence. This guideline should help decision-making by clinicians and patients regarding perioperative antirheumatic medication management at the time of elective THA or TKA. These conditional recommendations reflect the paucity of high-quality direct randomized controlled trial data. © 2017, American College of Rheumatology.

  18. Ten-Year Survival Results of a Randomized Trial of Irradiation of Internal Mammary Nodes After Mastectomy

    International Nuclear Information System (INIS)

    Hennequin, Christophe; Bossard, Nadine; Servagi-Vernat, Stéphanie; Maingon, Philippe; Dubois, Jean-Bernard; Datchary, Jean; Carrie, Christian; Roullet, Bernard; Suchaud, Jean-Philippe; Teissier, Eric; Lucardi, Audrey; Gerard, Jean-Pierre; Belot, Aurélien

    2013-01-01

    Purpose: To evaluate the efficacy of irradiation of internal mammary nodes (IMN) on 10-year overall survival in breast cancer patients after mastectomy. Methods and Patients: This multicenter phase 3 study enrolled patients with positive axillary nodes (pN+) or central/medial tumors with or without pN+. Other inclusion criteria were age <75 and a Karnofsky index ≥70. All patients received postoperative irradiation of the chest wall and supraclavicular nodes and were randomly assigned to receive IMN irradiation or not. Randomization was stratified by tumor location (medial/central or lateral), axillary lymph node status, and adjuvant therapy (chemotherapy vs no chemotherapy). The prescribed dose of irradiation to the target volumes was 50 Gy or equivalent. The first 5 intercostal spaces were included in the IMN target volume, and two-thirds of the dose (31.5 Gy) was given by electrons. The primary outcome was overall survival at 10 years. Disease-free survival and toxicity were secondary outcomes. Results: T total of 1334 patients were analyzed after a median follow-up of 11.3 years among the survivors. No benefit of IMN irradiation on the overall survival could be demonstrated: the 10-year overall survival was 59.3% in the IMN-nonirradiated group versus 62.6% in the IMN-irradiated group (P=.8). According to stratification factors, we defined 6 subgroups (medial/central or lateral tumor, pN0 [only for medial/central] or pN+, and chemotherapy or not). In all these subgroups, IMN irradiation did not significantly improve overall survival. Conclusions: In patients treated with 2-dimensional techniques, we failed to demonstrate a survival benefit for IMN irradiation. This study cannot rule out a moderate benefit, especially with more modern, conformal techniques applied to a higher risk population

  19. Intraoperative ketamine for prevention of postoperative delirium or pain after major surgery in older adults: an international, multicentre, double-blind, randomised clinical trial.

    Science.gov (United States)

    Avidan, Michael S; Maybrier, Hannah R; Abdallah, Arbi Ben; Jacobsohn, Eric; Vlisides, Phillip E; Pryor, Kane O; Veselis, Robert A; Grocott, Hilary P; Emmert, Daniel A; Rogers, Emma M; Downey, Robert J; Yulico, Heidi; Noh, Gyu-Jeong; Lee, Yonghun H; Waszynski, Christine M; Arya, Virendra K; Pagel, Paul S; Hudetz, Judith A; Muench, Maxwell R; Fritz, Bradley A; Waberski, Witold; Inouye, Sharon K; Mashour, George A

    2017-07-15

    Delirium is a common and serious postoperative complication. Subanaesthetic ketamine is often administered intraoperatively for postoperative analgesia, and some evidence suggests that ketamine prevents delirium. The primary purpose of this trial was to assess the effectiveness of ketamine for prevention of postoperative delirium in older adults. The Prevention of Delirium and Complications Associated with Surgical Treatments [PODCAST] study is a multicentre, international randomised trial that enrolled adults older than 60 years undergoing major cardiac and non-cardiac surgery under general anaesthesia. Using a computer-generated randomisation sequence we randomly assigned patients to one of three groups in blocks of 15 to receive placebo (normal saline), low-dose ketamine (0·5 mg/kg), or high dose ketamine (1·0 mg/kg) after induction of anaesthesia, before surgical incision. Participants, clinicians, and investigators were blinded to group assignment. Delirium was assessed twice daily in the first 3 postoperative days using the Confusion Assessment Method. We did analyses by intention-to-treat and assessed adverse events. This trial is registered with clinicaltrials.gov, number NCT01690988. Between Feb 6, 2014, and June 26, 2016, 1360 patients were assessed, and 672 were randomly assigned, with 222 in the placebo group, 227 in the 0·5 mg/kg ketamine group, and 223 in the 1·0 mg/kg ketamine group. There was no difference in delirium incidence between patients in the combined ketamine groups and the placebo group (19·45% vs 19·82%, respectively; absolute difference 0·36%, 95% CI -6·07 to 7·38, p=0·92). There were more postoperative hallucinations (p=0·01) and nightmares (p=0·03) with increasing ketamine doses compared with placebo. Adverse events (cardiovascular, renal, infectious, gastrointestinal, and bleeding), whether viewed individually (p value for each >0·40) or collectively (36·9% in placebo, 39·6% in 0·5 mg/kg ketamine, and 40·8% in 1·0

  20. Postmastectomy Radiation Therapy in Women with T1-T2 Tumors and 1 to 3 Positive Lymph Nodes: Analysis of the Breast International Group 02-98 Trial.

    Science.gov (United States)

    Zeidan, Youssef H; Habib, Joyce G; Ameye, Lieveke; Paesmans, Marianne; de Azambuja, Evandro; Gelber, Richard D; Campbell, Ian; Nordenskjöld, Bo; Gutiérez, Jorge; Anderson, Michael; Lluch, Ana; Gnant, Michael; Goldhirsch, Aron; Di Leo, Angelo; Joseph, David J; Crown, John; Piccart-Gebhart, Martine; Francis, Prudence A

    2018-06-01

    To analyze the impact of postmastectomy radiation therapy (PMRT) for patients with T1-T2 tumors and 1 to 3 positive lymph nodes enrolled on the Breast International Group (BIG) 02-98 trial. The BIG 02-98 trial randomized patients to receive adjuvant anthracycline with or without taxane chemotherapy. Delivery of PMRT was nonrandomized and performed according to institutional preferences. The present analysis was performed on participants with T1-T2 breast cancer and 1 to 3 positive lymph nodes who had undergone mastectomy and axillary nodal dissection. The primary objective of the present study was to examine the effect of PMRT on risk of locoregional recurrence (LRR), breast cancer-specific survival, and overall survival. We identified 684 patients who met the inclusion criteria and were included in the analysis, of whom 337 (49%) had received PMRT. At 10 years, LRR risk was 2.5% in the PMRT group and 6.5% in the no-PMRT group (hazard ratio 0.29, 95% confidence interval 0.12-0.73; P = .005). Lower LRR after PMRT was noted for patients randomized to receive adjuvant chemotherapy with no taxane (10-year LRR: 3.4% vs 9.1%; P = .02). No significant differences in breast cancer-specific survival (84.3% vs 83.9%) or overall survival (81.7% vs 78.3%) were observed according to receipt of PMRT. Our analysis of the BIG 02-98 trial shows excellent outcomes in women with T1-T2 tumors and 1 to 3 positive lymph nodes found in axillary dissection. Although PMRT improved LRR in this cohort, the number of events remained low at 10 years. In all groups, 10-year rates of LRR were relatively low compared with historical studies. As such, the use of PMRT in women with 1 to 3 positive nodes should be tailored to individual patient risks. Copyright © 2018 Elsevier Inc. All rights reserved.

  1. A multi-centre study of interactional style in nurse specialist- and physician-led Rheumatology clinics in the UK.

    Science.gov (United States)

    Vinall-Collier, Karen; Madill, Anna; Firth, Jill

    2016-07-01

    Nurse-led care is well established in Rheumatology in the UK and provides follow-up care to people with inflammatory arthritis including treatment, monitoring, patient education and psychosocial support. The aim of this study is to compare and contrast interactional style with patients in physician-led and nurse-led Rheumatology clinics. A multi-centre mixed methods approach was adopted. Nine UK Rheumatology out-patient clinics were observed and audio-recorded May 2009-April 2010. Eighteen practitioners agreed to participate in clinic audio-recordings, researcher observations, and note-taking. Of 9 nurse specialists, 8 were female and 5 of 9 physicians were female. Eight practitioners in each group took part in audio-recorded post-clinic interviews. All patients on the clinic list for those practitioners were invited to participate and 107 were consented and observed. In the nurse specialist cohort 46% were female; 71% had a diagnosis of Rheumatoid Arthritis (RA). The physician cohort comprised 31% female; 40% with RA and 16% unconfirmed diagnosis. Nineteen (18%) of the patients observed were approached for an audio-recorded telephone interview and 15 participated (4 male, 11 female). Forty-four nurse specialist and 63 physician consultations with patients were recorded. Roter's Interactional Analysis System (RIAS) was used to code this data. Thirty-one semi-structured interviews were conducted (16 practitioner, 15 patients) within 24h of observed consultations and were analyzed using thematic analysis. RIAS results illuminated differences between practitioners that can be classified as 'socio-emotional' versus 'task-focussed'. Specifically, nurse specialists and their patients engaged significantly more in the socio-emotional activity of 'building a relationship'. Across practitioners, the greatest proportion of 'patient initiations' were in 'giving medical information' and reflected what patients wanted the practitioner to know rather than giving insight into

  2. An individually randomized controlled trial to determine the effectiveness of the Women for Women International Programme in reducing intimate partner violence and strengthening livelihoods amongst women in Afghanistan: trial design, methods and baseline findings.

    Science.gov (United States)

    Gibbs, Andrew; Corboz, Julienne; Shafiq, Mohammed; Marofi, Frozan; Mecagni, Anna; Mann, Carron; Karim, Fazal; Chirwa, Esnat; Maxwell-Jones, Charlotte; Jewkes, Rachel

    2018-01-22

    Intimate Partner Violence (IPV) is the most common form of violence in conflict and post-conflict settings, but there are few evaluations of interventions to prevent IPV in such settings. The Women for Women International (WfWI) intervention is a year-long combined economic and social empowerment intervention for marginalized women survivors of conflict. Primarily, it seeks to support women to achieve four key outcomes: women earn and save money; women improve their health and well-being; women influence decisions in their homes and communities; women connect to networks for support. The organization recognizes Violence Against Women and Girls (VAWG) as a significant barrier to women's empowerment and expects to see reduction in VAWG, and specifically IPV, as part of building women's social and economic empowerment. This program is being quantitatively evaluated through an individually randomized control trial amongst women in Afghanistan, with a 24-month follow up. A comparison of baseline characteristics of participants is also included as well as a discussion of implementation of the baseline research. There is a high demand amongst Afghan women for such interventions, and this posed challenges in completing the randomization and baseline. In addition, the complex security situation in Afghanistan also posed challenges. However, despite these issues, recruitment was successfully achieved and the arms were balanced on socio-demographic measures. The evaluation will contribute to the limited evidence base on interventions to prevent IPV in conflict-affected settings. NCT03236948 . Registered 28 July 2017, retrospectively registered.

  3. EULAR task force recommendations on annual cardiovascular risk assessment for patients with rheumatoid arthritis: an audit of the success of implementation in a rheumatology outpatient clinic.

    Science.gov (United States)

    Ikdahl, Eirik; Rollefstad, Silvia; Olsen, Inge C; Kvien, Tore K; Hansen, Inger Johanne Widding; Soldal, Dag Magnar; Haugeberg, Glenn; Semb, Anne Grete

    2015-01-01

    EULAR recommendations for cardiovascular disease (CVD) risk management include annual CVD risk assessments for patients with rheumatoid arthritis (RA). We evaluated the recording of CVD risk factors (CVD-RF) in a rheumatology outpatient clinic, where EULAR recommendations had been implemented. Further, we compared CVD-RF recordings between a regular rheumatology outpatient clinic (RegROC) and a structured arthritis clinic (AC). In 2012, 1142 RA patients visited the rheumatology outpatient clinic: 612 attended RegROC and 530 attended AC. We conducted a search in the patient journals to ascertain the rate of CVD-RF recording. The overall CVD-RF recording rate was 40.1% in the rheumatology outpatient clinic, reflecting a recording rate of 59.1% in the AC and 23.6% in the RegROC. The odds ratios for having CVD-RFs recorded for patients attending AC compared to RegROC were as follows: blood pressure: 12.4, lipids: 5.0-6.0, glucose: 9.1, HbA1c: 6.1, smoking: 1.4, and for having all the CVD-RFs needed to calculate the CVD risk by the systematic coronary risk evaluation (SCORE): 21.0. The CVD-RF recording rate was low in a rheumatology outpatient clinic. However, a systematic team-based model was superior compared to a RegROC. Further measures are warranted to improve CVD-RF recording in RA patients.

  4. EULAR Task Force Recommendations on Annual Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis: An Audit of the Success of Implementation in a Rheumatology Outpatient Clinic

    Directory of Open Access Journals (Sweden)

    Eirik Ikdahl

    2015-01-01

    Full Text Available Objective. EULAR recommendations for cardiovascular disease (CVD risk management include annual CVD risk assessments for patients with rheumatoid arthritis (RA. We evaluated the recording of CVD risk factors (CVD-RF in a rheumatology outpatient clinic, where EULAR recommendations had been implemented. Further, we compared CVD-RF recordings between a regular rheumatology outpatient clinic (RegROC and a structured arthritis clinic (AC. Methods. In 2012, 1142 RA patients visited the rheumatology outpatient clinic: 612 attended RegROC and 530 attended AC. We conducted a search in the patient journals to ascertain the rate of CVD-RF recording. Results. The overall CVD-RF recording rate was 40.1% in the rheumatology outpatient clinic, reflecting a recording rate of 59.1% in the AC and 23.6% in the RegROC. The odds ratios for having CVD-RFs recorded for patients attending AC compared to RegROC were as follows: blood pressure: 12.4, lipids: 5.0-6.0, glucose: 9.1, HbA1c: 6.1, smoking: 1.4, and for having all the CVD-RFs needed to calculate the CVD risk by the systematic coronary risk evaluation (SCORE: 21.0. Conclusion. The CVD-RF recording rate was low in a rheumatology outpatient clinic. However, a systematic team-based model was superior compared to a RegROC. Further measures are warranted to improve CVD-RF recording in RA patients.

  5. Getting back to the dissecting room: An evaluation of an innovative course in musculoskeletal anatomy for UK-based rheumatology training.

    Science.gov (United States)

    Blake, Tim; Marais, Debbi; Hassell, Andrew B; Stevenson, Kay; Paskins, Zoe

    2017-12-01

    The rheumatologist relies heavily on clinical skills to diagnose diverse conditions, something that is correlated with one's knowledge of clinical anatomy. More recently, rheumatology has offered further career flexibility with opportunities to develop skills such as joint injection and musculoskeletal (MSK) ultrasound, both of which require a sound understanding of anatomy. Currently, there are no formal strategies to support competency-based anatomy learning in rheumatology in the UK. This study aimed to evaluate an innovative applied anatomy course utilizing cadaveric material, targeted at clinicians practising in rheumatology and MSK medicine. A new course was developed for rheumatologists, rheumatology trainees and allied health professionals practising rheumatology and MSK medicine, with the principal focus being on applied MSK anatomy. A questionnaire was given to course attendees and a mixed methods approach of evaluation used. Descriptive statistical data analysis was performed. The course received overall positive feedback and statistically significant improvements in levels of confidence in anatomy (mean 52.35-83.53, p attendees also favoured a peer-assisted and multidisciplinary learning approach. This study lends support for the use of cadaveric material in the teaching of postgraduate anatomy to rheumatologists. It has demonstrated a continual need for hands-on and interactive anatomy training in an ever-advancing digital world. To be successful, cadaveric learning should not be viewed in a purely 'pre-clinical' setting, but instead integrated with postgraduate learning. Copyright © 2017 John Wiley & Sons, Ltd.

  6. Reducing and preventing internalizing and externalizing behavior problems in children with type 1 diabetes: a randomized controlled trial of the Triple P-Positive Parenting Program.

    Science.gov (United States)

    Westrupp, E M; Northam, E; Lee, K J; Scratch, S E; Cameron, F

    2015-11-01

    Children with type 1 diabetes are at increased risk of mental health problems, which in turn are associated with poor glycemic control, diabetes-related complications, and long-term psychiatric morbidity. We tested the efficacy of the Triple P-Positive Parenting Program in reducing or preventing mental health problems and improving glycemic control in children with type 1 diabetes in a randomized controlled trial. Participants were recruited from the Diabetes Clinic, Royal Children's Hospital, Melbourne, Australia, and randomized to Triple P or standard diabetes care. The primary outcome was child internalizing and externalizing behavior problems 3 and 12 months postrandomization. Secondary outcomes were glycemic control, parent mental health, parenting skills, and family functioning at 3 and 12 months, and glycemic control at 24 months. A total of 76 participants were randomized (38 to intervention and 38 to control), 60 completed 3-month, and 57 completed 12-month assessments. Benefits of Triple P were evident at 3 months for parent mental health, parenting skills, and family functioning (p externalizing behavior problems indicated greater improvements in child mental health, parent mental health, parenting skills, and diabetes family conflict (p parenting self-efficacy at 3 months. Improvements in parent mental health and parenting competency associated with Triple P were sustained to 12 months for children with pre-existing mental health problems. This study provides some support for the efficacy of Triple P in improving parent and family outcomes, and reducing child internalizing and externalizing behavior problems primarily in children who have pre-existing mental health problems. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  7. Resuscitation of asphyxiated newborn infants with room air or oxygen: an international controlled trial: the Resair 2 study.

    Science.gov (United States)

    Saugstad, O D; Rootwelt, T; Aalen, O

    1998-07-01

    Birth asphyxia represents a serious problem worldwide, resulting in approximately 1 million deaths and an equal number of serious sequelae annually. It is therefore important to develop new and better ways to treat asphyxia. Resuscitation after birth asphyxia traditionally has been carried out with 100% oxygen, and most guidelines and textbooks recommend this; however, the scientific background for this has never been established. On the contrary, theoretic considerations indicate that resuscitation with high oxygen concentrations could have detrimental effects. We have performed a series of animal studies as well as one pilot study indicating that resuscitation can be performed with room air just as efficiently as with 100% oxygen. To test this more thoroughly, we organized a multicenter study and hypothesized that room air is superior to 100% oxygen when asphyxiated newborn infants are resuscitated. In a prospective, international, controlled multicenter study including 11 centers from six countries, asphyxiated newborn infants with birth weight >999 g were allocated to resuscitation with either room air or 100% oxygen. The study was not blinded, and the patients were allocated to one of the two treatment groups according to date of birth. Those born on even dates were resuscitated with room air and those born on odd dates with 100% oxygen. Informed consent was not obtained until after the initial resuscitation, an arrangement in agreement with the new proposal of the US Food and Drug Administration's rules governing investigational drugs and medical devices to permit clinical research on emergency care without the consent of subjects. The protocol was approved by the ethical committees at each participating center. Entry criterion was apnea or gasping with heart rate Apgar score at 5 minutes, heart rate at 90 seconds, time to first breath, time to first cry, duration of resuscitation, arterial blood gases and acid base status at 10 and 30 minutes of age, and

  8. A Preliminary Core Domain Set for Clinical Trials of Shoulder Disorders: A Report from the OMERACT 2016 Shoulder Core Outcome Set Special Interest Group.

    Science.gov (United States)

    Buchbinder, Rachelle; Page, Matthew J; Huang, Hsiaomin; Verhagen, Arianne P; Beaton, Dorcas; Kopkow, Christian; Lenza, Mario; Jain, Nitin B; Richards, Bethan; Richards, Pamela; Voshaar, Marieke; van der Windt, Danielle; Gagnier, Joel J

    2017-12-01

    The Outcome Measures in Rheumatology (OMERACT) Shoulder Core Outcome Set Special Interest Group (SIG) was established to develop a core outcome set (COS) for clinical trials of shoulder disorders. In preparation for OMERACT 2016, we systematically examined all outcome domains and measurement instruments reported in 409 randomized trials of interventions for shoulder disorders published between 1954 and 2015. Informed by these data, we conducted an international Delphi consensus study including shoulder trial experts, clinicians, and patients to identify key domains that should be included in a shoulder disorder COS. Findings were discussed at a stakeholder premeeting of OMERACT. At OMERACT 2016, we sought consensus on a preliminary core domain set and input into next steps. There were 13 and 15 participants at the premeeting and the OMERACT 2016 SIG meeting, respectively (9 attended both meetings). Consensus was reached on a preliminary core domain set consisting of an inner core of 4 domains: pain, physical function/activity, global perceived effect, and adverse events including death. A middle core consisted of 3 domains: emotional well-being, sleep, and participation (recreation and work). An outer core of research required to inform the final COS was also formulated. Our next steps are to (1) analyze whether participation (recreation and work) should be in the inner core, (2) conduct a third Delphi round to finalize definitions and wording of domains and reach final endorsement for the domains, and (3) determine which instruments fulfill the OMERACT criteria for measuring each domain.

  9. Validation of International Society of Urological Pathology (ISUP) grading for prostatic adenocarcinoma in thin core biopsies using TROG 03.04 'RADAR' trial clinical data.

    Science.gov (United States)

    Delahunt, B; Egevad, L; Srigley, J R; Steigler, A; Murray, J D; Atkinson, C; Matthews, J; Duchesne, G; Spry, N A; Christie, D; Joseph, D; Attia, J; Denham, J W

    2015-10-01

    In 2014 a consensus conference convened by the International Society of Urological Pathology (ISUP) adopted amendments to the criteria for Gleason grading and scoring (GS) for prostatic adenocarcinoma. The meeting defined a modified grading system based on 5 grading categories (grade 1, GS 3+3; grade 2, GS 3+4; grade 3, GS 4+3; grade 4, GS 8; grade 5, GS 9-10). In this study we have evaluated the prognostic significance of ISUP grading in 496 patients enrolled in the TROG 03.04 RADAR Trial. There were 19 grade 1, 118 grade 2, 193 grade 3, 88 grade 4 and 79 grade 5 tumours in the series, with follow-up for a minimum of 6.5 years. On follow-up 76 patients experienced distant progression of disease, 171 prostate specific antigen (PSA) progression and 39 prostate cancer deaths. In contrast to the 2005 modified Gleason system (MGS), the hazards of the distant and PSA progression endpoints, relative to grade 2, were significantly greater for grades 3, 4 and 5 of the 2014 ISUP grading scheme. Comparison of predictive ability utilising Harrell's concordance index, showed 2014 ISUP grading to significantly out-perform 2005 MGS grading for each of the three clinical endpoints.

  10. Regional hyperthermia combined with radiotherapy for locally advanced non-small cell lung cancers. A multi-institutional prospective randomized trial of the International Atomic Energy Agency

    International Nuclear Information System (INIS)

    Mitsumori, Michihide; Hiraoka, Masahiro; Zeng Zhifan; Oliynychenko, P.; Park, Jeong-Ho; Choi, Ihl-Bohng; Tatsuzaki, Hideo; Tanaka, Yoshiaki

    2007-01-01

    An International Atomic Energy Agency (IAEA)-sponsored, multi-institutional prospective randomized trial was conducted to clarify whether the combination of hyperthermia and radiotherapy improves the local response rate of locally advanced non-small cell lung cancer (NSCLC) compared with that obtained by radiotherapy alone. Between October 1998 and April 2002, 80 patients with locally advanced NSCLC were randomized to receive either standard radiation therapy alone (RT) or radiation therapy combined with hyperthermia (RT+HT). The primary endpoint was the local response rate. The secondary endpoints were local progression-free survival and overall survival. The median follow-up period was 204 days for all patients and 450 days for surviving patients. There were no significant differences between the two arms with regard to local response rate (P=0.49) or overall survival rate (P=0.868). However, local progression-free survival was significantly better in the RT+HT arm (P=0.036). Toxicity was generally mild and no grade 3 late toxicity was observed in either arm. Although improvement of local progression-free survival was observed in the RT+HT arm, this prospective randomized study failed to show any substantial benefit from the addition of hyperthermia to radiotherapy in the treatment of locally advanced NSCLC. (author)

  11. Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trial.

    Science.gov (United States)

    Sprigg, Nikola; Flaherty, Katie; Appleton, Jason P; Al-Shahi Salman, Rustam; Bereczki, Daniel; Beridze, Maia; Christensen, Hanne; Ciccone, Alfonso; Collins, Ronan; Czlonkowska, Anna; Dineen, Robert A; Duley, Lelia; Egea-Guerrero, Juan Jose; England, Timothy J; Krishnan, Kailash; Laska, Ann Charlotte; Law, Zhe Kang; Ozturk, Serefnur; Pocock, Stuart J; Roberts, Ian; Robinson, Thompson G; Roffe, Christine; Seiffge, David; Scutt, Polly; Thanabalan, Jegan; Werring, David; Whynes, David; Bath, Philip M

    2018-05-26

    Tranexamic acid can prevent death due to bleeding after trauma and post-partum haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke due to intracerebral haemorrhage. We did an international, randomised placebo-controlled trial in adults with intracerebral haemorrhage from acute stroke units at 124 hospital sites in 12 countries. Participants were randomly assigned (1:1) to receive 1 g intravenous tranexamic acid bolus followed by an 8 h infusion of 1 g tranexamic acid or a matching placebo, within 8 h of symptom onset. Randomisation was done centrally in real time via a secure website, with stratification by country and minimisation on key prognostic factors. Treatment allocation was concealed from patients, outcome assessors, and all other health-care workers involved in the trial. The primary outcome was functional status at day 90, measured by shift in the modified Rankin Scale, using ordinal logistic regression with adjustment for stratification and minimisation criteria. All analyses were done on an intention-to-treat basis. This trial is registered with the ISRCTN registry, number ISRCTN93732214. We recruited 2325 participants between March 1, 2013, and Sept 30, 2017. 1161 patients received tranexamic acid and 1164 received placebo; the treatment groups were well balanced at baseline. The primary outcome was assessed for 2307 (99%) participants. The primary outcome, functional status at day 90, did not differ significantly between the groups (adjusted odds ratio [aOR] 0·88, 95% CI 0·76-1·03, p=0·11). Although there were fewer deaths by day 7 in the tranexamic acid group (101 [9%] deaths in the tranexamic acid group vs 123 [11%] deaths in the placebo group; aOR 0·73, 0·53-0·99, p=0·0406), there was no difference in case fatality at 90 days (250 [22%] vs 249 [21%]; adjusted hazard ratio 0·92, 95% CI 0·77-1·10, p=0·37). Fewer patients had serious adverse events after tranexamic

  12. Teaching musculoskeletal examination skills to UK medical students: a comparative survey of Rheumatology and Orthopaedic education practice.

    Science.gov (United States)

    Blake, Tim

    2014-03-28

    Specialists in Rheumatology and Orthopaedics are frequently involved in undergraduate teaching of musculoskeletal (MSK) examination skills. Students often report that specialty-led teaching is inconsistent, confusing and bears little resemblance to the curricula. The Gait, Arms, Legs and Spine (GALS) is a MSK screening tool that provides a standardised approach to examination despite it being fraught with disapproval and low uptake. Recent studies would appear to support innovative instructional methods of engaging learners such as patient educators and interactive small group teaching. This comparative cross-sectional survey evaluates the current state of undergraduate teaching in Rheumatology and Orthopaedics, including preferred teaching methods, attitudes towards GALS, and barriers to effective teaching. An electronic questionnaire was sent to specialist trainees and Consultants in the East and West Midlands region, representing 5 UK medical schools. Descriptive statistical data analysis was performed. There were 76 respondents representing 5 medical schools. There was a request for newer teaching methodologies to be used: multi-media computer-assisted learning (35.5%), audio-visual aids (31.6%), role-playing (19.7%), and social media (3.9%). It is evident that GALS is under-utilised with 50% of clinicians not using GALS in their teaching. There is a genuine desire for clinical educators to improve their teaching ability, collaborate more with curriculum planners, and feel valued by institutions. There remains a call for implementing a standardised approach to MSK clinical teaching to supersede GALS.

  13. A concise evaluation and management curriculum for physicians in training improved billing at an outpatient academic rheumatology clinic.

    Science.gov (United States)

    Hirsh, Joel M; Collier, David H; Boyle, Dennis J; Gardner, Edward M

    2010-04-01

    To study whether providing house staff with a brief lecture and handout about proper documentation could improve billing at an academic rheumatology clinic. The authors created an educational sheet about documentation and billing after a review of the common documentation omissions responsible for down coding (Appendix, Supplemental Digital Content 1, available at: http://links.lww.com/RHU/A8). Beginning in November of 2006, the house staff were provided with this sheet and a brief lecture regarding how outpatient evaluation and management levels of service are coded. The results of clinic billing from January 1, 2006 to October 31, 2006 and November 1, 2006 to August 31, 2007 were obtained from the physician billing office. The authors compared the average level of service, by appointment type, in the prepost comparison periods using the student t test. There was a significant improvement in the level of service billed for new visits (P < 0.001), consults (P < 0.001), and return visits (P < 0.001) after November 1, 2006. The percentage of patients evaluated for the first time who were billed as consults improved from 15% to 78% (P < 0.001 by chi2). These changes resulted in $34,342 of additional billing during the postintervention period. A simple strategy for educating the house staff about proper documentation of the history, physical examination, and clinical decision making resulted in a significant improvement in an academic rheumatology division's outpatient billing.

  14. Effects of a partially supervised conditioning programme in cystic fibrosis: an international multi-centre randomised controlled trial (ACTIVATE-CF): study protocol.

    Science.gov (United States)

    Hebestreit, Helge; Lands, Larry C; Alarie, Nancy; Schaeff, Jonathan; Karila, Chantal; Orenstein, David M; Urquhart, Don S; Hulzebos, Erik H J; Stein, Lothar; Schindler, Christian; Kriemler, Susi; Radtke, Thomas

    2018-02-08

    motivational feedback on several health outcomes using modern technology. Should this relatively simple programme prove successful, it will be made available on a wider scale internationally. ClinicalTrials.gov Identifier: NCT01744561 ; Registration date: December 6, 2012.

  15. Secondary mediation and regression analyses of the PTClinResNet database: determining causal relationships among the International Classification of Functioning, Disability and Health levels for four physical therapy intervention trials.

    Science.gov (United States)

    Mulroy, Sara J; Winstein, Carolee J; Kulig, Kornelia; Beneck, George J; Fowler, Eileen G; DeMuth, Sharon K; Sullivan, Katherine J; Brown, David A; Lane, Christianne J

    2011-12-01

    Each of the 4 randomized clinical trials (RCTs) hosted by the Physical Therapy Clinical Research Network (PTClinResNet) targeted a different disability group (low back disorder in the Muscle-Specific Strength Training Effectiveness After Lumbar Microdiskectomy [MUSSEL] trial, chronic spinal cord injury in the Strengthening and Optimal Movements for Painful Shoulders in Chronic Spinal Cord Injury [STOMPS] trial, adult stroke in the Strength Training Effectiveness Post-Stroke [STEPS] trial, and pediatric cerebral palsy in the Pediatric Endurance and Limb Strengthening [PEDALS] trial for children with spastic diplegic cerebral palsy) and tested the effectiveness of a muscle-specific or functional activity-based intervention on primary outcomes that captured pain (STOMPS, MUSSEL) or locomotor function (STEPS, PEDALS). The focus of these secondary analyses was to determine causal relationships among outcomes across levels of the International Classification of Functioning, Disability and Health (ICF) framework for the 4 RCTs. With the database from PTClinResNet, we used 2 separate secondary statistical approaches-mediation analysis for the MUSSEL and STOMPS trials and regression analysis for the STEPS and PEDALS trials-to test relationships among muscle performance, primary outcomes (pain related and locomotor related), activity and participation measures, and overall quality of life. Predictive models were stronger for the 2 studies with pain-related primary outcomes. Change in muscle performance mediated or predicted reductions in pain for the MUSSEL and STOMPS trials and, to some extent, walking speed for the STEPS trial. Changes in primary outcome variables were significantly related to changes in activity and participation variables for all 4 trials. Improvement in activity and participation outcomes mediated or predicted increases in overall quality of life for the 3 trials with adult populations. Variables included in the statistical models were limited to those

  16. Therapeutic Drug Monitoring of Asparaginase Activity-Method Comparison of MAAT and AHA Test Used in the International AIEOP-BFM ALL 2009 Trial.

    Science.gov (United States)

    Lanvers-Kaminsky, Claudia; Rüffer, Andrea; Würthwein, Gudrun; Gerss, Joachim; Zucchetti, Massimo; Ballerini, Andrea; Attarbaschi, Andishe; Smisek, Petr; Nath, Christa; Lee, Samiuela; Elitzur, Sara; Zimmermann, Martin; Möricke, Anja; Schrappe, Martin; Rizzari, Carmelo; Boos, Joachim

    2018-02-01

    In the international AIEOP-BFM ALL 2009 trial, asparaginase (ASE) activity was monitored after each dose of pegylated Escherichia coli ASE (PEG-ASE). Two methods were used: the aspartic acid β-hydroxamate (AHA) test and medac asparaginase activity test (MAAT). As the latter method overestimates PEG-ASE activity because it calibrates using E. coli ASE, method comparison was performed using samples from the AIEOP-BFM ALL 2009 trial. PEG-ASE activities were determined using MAAT and AHA test in 2 sets of samples (first set: 630 samples and second set: 91 samples). Bland-Altman analysis was performed on ratios between MAAT and AHA tests. The mean difference between both methods, limits of agreement, and 95% confidence intervals were calculated and compared for all samples and samples grouped according to the calibration ranges of the MAAT and the AHA test. PEG-ASE activity determined using the MAAT was significantly higher than when determined using the AHA test (P Wilcoxon signed-rank test). Within the calibration range of the MAAT (30-600 U/L), PEG-ASE activities determined using the MAAT were on average 23% higher than PEG-ASE activities determined using the AHA test. This complies with the mean difference reported in the MAAT manual. With PEG-ASE activities >600 U/L, the discrepancies between MAAT and AHA test increased. Above the calibration range of the MAAT (>600 U/L) and the AHA test (>1000 U/L), a mean difference of 42% was determined. Because more than 70% of samples had PEG-ASE activities >600 U/L and required additional sample dilution, an overall mean difference of 37% was calculated for all samples (37% for the first and 34% for the second set). Comparison of the MAAT and AHA test for PEG-ASE activity confirmed a mean difference of 23% between MAAT and AHA test for PEG-ASE activities between 30 and 600 U/L. The discrepancy increased in samples with >600 U/L PEG-ASE activity, which will be especially relevant when evaluating high PEG-ASE activities in

  17. Multivariable and Bayesian Network Analysis of Outcome Predictors in Acute Aneurysmal Subarachnoid Hemorrhage: Review of a Pure Surgical Series in the Post-International Subarachnoid Aneurysm Trial Era.

    Science.gov (United States)

    Zador, Zsolt; Huang, Wendy; Sperrin, Matthew; Lawton, Michael T

    2018-06-01

    Following the International Subarachnoid Aneurysm Trial (ISAT), evolving treatment modalities for acute aneurysmal subarachnoid hemorrhage (aSAH) has changed the case mix of patients undergoing urgent surgical clipping. To update our knowledge on outcome predictors by analyzing admission parameters in a pure surgical series using variable importance ranking and machine learning. We reviewed a single surgeon's case series of 226 patients suffering from aSAH treated with urgent surgical clipping. Predictions were made using logistic regression models, and predictive performance was assessed using areas under the receiver operating curve (AUC). We established variable importance ranking using partial Nagelkerke R2 scores. Probabilistic associations between variables were depicted using Bayesian networks, a method of machine learning. Importance ranking showed that World Federation of Neurosurgical Societies (WFNS) grade and age were the most influential outcome prognosticators. Inclusion of only these 2 predictors was sufficient to maintain model performance compared to when all variables were considered (AUC = 0.8222, 95% confidence interval (CI): 0.7646-0.88 vs 0.8218, 95% CI: 0.7616-0.8821, respectively, DeLong's P = .992). Bayesian networks showed that age and WFNS grade were associated with several variables such as laboratory results and cardiorespiratory parameters. Our study is the first to report early outcomes and formal predictor importance ranking following aSAH in a post-ISAT surgical case series. Models showed good predictive power with fewer relevant predictors than in similar size series. Bayesian networks proved to be a powerful tool in visualizing the widespread association of the 2 key predictors with admission variables, explaining their importance and demonstrating the potential for hypothesis generation.

  18. Cost-effectiveness of internal limiting membrane peeling versus no peeling for patients with an idiopathic full-thickness macular hole: results from a randomised controlled trial.

    Science.gov (United States)

    Ternent, Laura; Vale, Luke; Boachie, Charles; Burr, Jennifer M; Lois, Noemi

    2012-03-01

    To determine whether internal limiting membrane (ILM) peeling is cost-effective compared with no peeling for patients with an idiopathic stage 2 or 3 full-thickness macular hole. A cost-effectiveness analysis was performed alongside a randomised controlled trial. 141 participants were randomly allocated to receive macular-hole surgery, with either ILM peeling or no peeling. Health-service resource use, costs and quality of life were calculated for each participant. The incremental cost per quality-adjusted life year (QALY) gained was calculated at 6 months. At 6 months, the total costs were on average higher (£424, 95% CI -182 to 1045) in the No Peel arm, primarily owing to the higher reoperation rate in the No Peel arm. The mean additional QALYs from ILM peel at 6 months were 0.002 (95% CI 0.01 to 0.013), adjusting for baseline EQ-5D and other minimisation factors. A mean incremental cost per QALY was not computed, as Peeling was on average less costly and slightly more effective. A stochastic analysis suggested that there was more than a 90% probability that Peeling would be cost-effective at a willingness-to-pay threshold of £20,000 per QALY. Although there is no evidence of a statistically significant difference in either costs or QALYs between macular hole surgery with or without ILM peeling, the balance of probabilities is that ILM Peeling is likely to be a cost-effective option for the treatment of macular holes. Further long-term follow-up data are needed to confirm these findings.

  19. Timing of Radiation Therapy and Chemotherapy After Breast-Conserving Surgery for Node-Positive Breast Cancer: Long-Term Results From International Breast Cancer Study Group Trials VI and VII

    International Nuclear Information System (INIS)

    Karlsson, Per; Cole, Bernard F.; Price, Karen N.; Gelber, Richard D.; Coates, Alan S.; Goldhirsch, Aron; Castiglione, Monica; Colleoni, Marco; Gruber, Günther

    2016-01-01

    Purpose: To update the previous report from 2 randomized clinical trials, now with a median follow-up of 16 years, to analyze the effect of radiation therapy timing on local failure and disease-free survival. Patients and Methods: From July 1986 to April 1993, International Breast Cancer Study Group trial VI randomly assigned 1475 pre-/perimenopausal women with node-positive breast cancer to receive 3 or 6 cycles of initial chemotherapy (CT). International Breast Cancer Study Group trial VII randomly assigned 1212 postmenopausal women with node-positive breast cancer to receive tamoxifen for 5 years, or tamoxifen for 5 years with 3 early cycles of initial CT. For patients who received breast-conserving surgery (BCS), radiation therapy (RT) was delayed until initial CT was completed; 4 or 7 months after BCS for trial VI and 2 or 4 months for trial VII. We compared RT timing groups among 433 patients on trial VI and 285 patients on trial VII who received BCS plus RT. Endpoints were local failure, regional/distant failure, and disease-free survival (DFS). Results: Among pre-/perimenopausal patients there were no significant differences in disease-related outcomes. The 15-year DFS was 48.2% in the group allocated 3 months initial CT and 44.9% in the group allocated 6 months initial CT (hazard ratio [HR] 1.12; 95% confidence interval [CI] 0.87-1.45). Among postmenopausal patients, the 15-year DFS was 46.1% in the no-initial-CT group and 43.3% in the group allocated 3 months initial CT (HR 1.11; 95% CI 0.82-1.51). Corresponding HRs for local failures were 0.94 (95% CI 0.61-1.46) in trial VI and 1.51 (95% CI 0.77-2.97) in trial VII. For regional/distant failures, the respective HRs were 1.15 (95% CI 0.80-1.63) and 1.08 (95% CI 0.69-1.68). Conclusions: This study confirms that, after more than 15 years of follow-up, it is reasonable to delay radiation therapy until after the completion of standard CT.

  20. Timing of Radiation Therapy and Chemotherapy After Breast-Conserving Surgery for Node-Positive Breast Cancer: Long-Term Results From International Breast Cancer Study Group Trials VI and VII

    Energy Technology Data Exchange (ETDEWEB)

    Karlsson, Per, E-mail: per.karlsson@oncology.gu.se [Department of Oncology, Institute of Clinical Sciences, Sahgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg (Sweden); Cole, Bernard F. [Department of Mathematics and Statistics, University of Vermont, Burlington, Vermont (United States); Price, Karen N. [International Breast Cancer Study Group Statistical Center, Frontier Science and Technology Research Foundation, Boston, Massachusetts (United States); Gelber, Richard D. [International Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Frontier Science and Technology Research Foundation, Harvard T. F. Chan School of Public Health, Boston, Massachusetts (United States); Coates, Alan S. [International Breast Cancer Study Group and University of Sydney, Sydney (Australia); Goldhirsch, Aron [Senior Consultant Breast Cancer, European Institute of Oncology and International Breast Cancer Study Group, Milan (Italy); Castiglione, Monica [International Breast Cancer Study Group, Bern (Switzerland); Colleoni, Marco [Division of Medical Senology, European Institute of Oncology and International Breast Cancer Study Group, Milan (Italy); Gruber, Günther [Institute of Radiotherapy, Klinik Hirslanden, Zürich (Switzerland)

    2016-10-01

    Purpose: To update the previous report from 2 randomized clinical trials, now with a median follow-up of 16 years, to analyze the effect of radiation therapy timing on local failure and disease-free survival. Patients and Methods: From July 1986 to April 1993, International Breast Cancer Study Group trial VI randomly assigned 1475 pre-/perimenopausal women with node-positive breast cancer to receive 3 or 6 cycles of initial chemotherapy (CT). International Breast Cancer Study Group trial VII randomly assigned 1212 postmenopausal women with node-positive breast cancer to receive tamoxifen for 5 years, or tamoxifen for 5 years with 3 early cycles of initial CT. For patients who received breast-conserving surgery (BCS), radiation therapy (RT) was delayed until initial CT was completed; 4 or 7 months after BCS for trial VI and 2 or 4 months for trial VII. We compared RT timing groups among 433 patients on trial VI and 285 patients on trial VII who received BCS plus RT. Endpoints were local failure, regional/distant failure, and disease-free survival (DFS). Results: Among pre-/perimenopausal patients there were no significant differences in disease-related outcomes. The 15-year DFS was 48.2% in the group allocated 3 months initial CT and 44.9% in the group allocated 6 months initial CT (hazard ratio [HR] 1.12; 95% confidence interval [CI] 0.87-1.45). Among postmenopausal patients, the 15-year DFS was 46.1% in the no-initial-CT group and 43.3% in the group allocated 3 months initial CT (HR 1.11; 95% CI 0.82-1.51). Corresponding HRs for local failures were 0.94 (95% CI 0.61-1.46) in trial VI and 1.51 (95% CI 0.77-2.97) in trial VII. For regional/distant failures, the respective HRs were 1.15 (95% CI 0.80-1.63) and 1.08 (95% CI 0.69-1.68). Conclusions: This study confirms that, after more than 15 years of follow-up, it is reasonable to delay radiation therapy until after the completion of standard CT.

  1. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... humans. What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or ...

  2. The Place of Nailfold Capillaroscopy Among Instrumental Methods for Assessment of Some Peripheral Ischaemic Syndromes in Rheumatology.

    Science.gov (United States)

    Lambova, Sevdalina N

    2016-01-01

    Micro- and macrovascular pathology is a frequent finding in a number of common rheumatic diseases. Secondary Raynaud's phenomenon (RP) is among the most common symptoms in systemic sclerosis and several other systemic autoimmune diseases including a broad differential diagnosis. It should be also differential from other peripheral vascular syndromes such as embolism, thrombosis, etc., some of which lead to clinical manifestation of the blue toe syndrome. The current review discusses the instrumental methods for vascular assessments. Nailfold capillaroscopy is the only method among the imaging techniques that can be used for morphological assessment of the nutritive capillaries in the nailfold area. Laser-Doppler flowmetry and laser-Doppler imaging are methods for functional assessment of microcirculation, while thermography and plethysmography reflect both blood flow in peripheral arteries and microcirculation. Doppler ultrasound and angiography visualize peripheral arteries. The choice of the appropriate instrumental method is guided by the clinical presentation. The main role of capillaroscopy is to provide differential diagnosis between primary and secondary RP. In rheumatology, capillaroscopic changes in systemic sclerosis have been recently defined as diagnostic. The appearance of abnormal capillaroscopic pattern inherits high positive predictive value for the development of a connective tissue disease that is higher than the predictive value of antinuclear antibodies. In cases of abrupt onset of peripheral ischaemia, clinical signs of critical ischaemia, unilateral or lower limb involvement, Doppler ultrasound and angiography are indicated. The most common causes for such clinical picture that may be referred to rheumatologic consultation are the antiphospholipid syndrome, mimickers of vasculitides such as atherosclerosis with cholesterol emboli, and neoplasms.

  3. Conversion rates of abstracts presented at the Canadian Rheumatology Association Annual Meetings into full-text journal articles.

    Science.gov (United States)

    Yacyshyn, Elaine A; Soong, Laura C

    2017-06-01

    Dissemination of research studies is important for research ideas to be transformed from initial abstracts to full publications. Analyses of the scientific impact and publication record of the Canadian Rheumatology Association (CRA) Annual meeting have not been previously described. This study determines the publication rate of abstracts presented at the CRA Annual Meetings 2005-2013 to full-text journal articles and the factors associated with publication. Program records of previous CRA meetings from 2005 to 2013 were obtained. Abstracts were searched for corresponding full-text publication in Google Scholar and PubMed using a search algorithm. Abstracts and subsequent published articles were evaluated for type of abstract, time to publication, study type, publishing journal, and journal impact factor. A total of 1401 abstracts were included in the study, 567 of which were converted to full publications. The average time to publication was 19.7 months, with 89% of abstracts published within 3 years of being presented. Eighty-three percent of abstracts were clinical in nature, and 58% of published studies were observational in design. Articles were published in a wide range of journals, with the top publisher being the Journal of Rheumatology (31%). Average time to publication was 19.7 months. Eighty-six percent of articles had a Journal Impact Factor > 2. Overall, 40.5% of abstracts presented at the CRA Annual Meetings 2005-2013 were published. Further research is needed to determine barriers and reasons for abstracts not being published as full-text articles.

  4. Development and Preliminary Face and Content Validation of the "Which Health Approaches and Treatments Are You Using?" (WHAT) Questionnaires Assessing Complementary and Alternative Medicine Use in Pediatric Rheumatology.

    Science.gov (United States)

    Toupin April, Karine; Stinson, Jennifer; Boon, Heather; Duffy, Ciarán M; Huber, Adam M; Gibbon, Michele; Descarreaux, Martin; Spiegel, Lynn; Vohra, Sunita; Tugwell, Peter

    2016-01-01

    Complementary and alternative medicine (CAM) is commonly used by children with juvenile idiopathic arthritis (JIA), yet no validated questionnaires assess that use. The objective of this study was to develop child self- and parent proxy-report questionnaires assessing CAM use and to determine the face and content validity of the "Which Health Approaches and Treatments are you using?" (WHAT) questionnaires in pediatric rheumatology. A sequential phased mixed methods approach was used to develop the questionnaires. A Delphi Survey of 126 experts followed by an interdisciplinary consensus conference of 14 stakeholders in CAM, general pediatrics and pediatric rheumatology was held to develop consensus on the content of the questionnaires using a nominal group technique. To determine face and content validity of the questionnaires, two groups, including (a) a purposive sample of 22 children with JIA 8 to 18 years and their parents from the Children's Hospital of Eastern Ontario and the Hospital for Sick Children, and (b) 21 Canadian pediatric rheumatology experts, participated in interviews. Participants were independently asked about the goal, understandability and comprehensiveness of the WHAT questionnaires, as well as the relevance of items. Consensus was reached on 17 items of the WHAT questionnaires. The domains found to be relevant were child's CAM use, factors associated with CAM use, perceived impact of CAM use, and communication about CAM. A total of 15 items in the parent proxy-report questionnaire and 13 items in the child report questionnaire showed adequate content validity. Consensus was reached by experts on the content of a pediatric CAM questionnaire. Face and content validity testing and modifications made to the WHAT questionnaires have helped ensure adequate preliminary validity for use in pediatric rheumatology. This constitutes the basis for further testing of these questionnaires in pediatric rheumatology and for adaptation to other chronic

  5. Development and Preliminary Face and Content Validation of the "Which Health Approaches and Treatments Are You Using?" (WHAT Questionnaires Assessing Complementary and Alternative Medicine Use in Pediatric Rheumatology.

    Directory of Open Access Journals (Sweden)

    Karine Toupin April

    Full Text Available Complementary and alternative medicine (CAM is commonly used by children with juvenile idiopathic arthritis (JIA, yet no validated questionnaires assess that use. The objective of this study was to develop child self- and parent proxy-report questionnaires assessing CAM use and to determine the face and content validity of the "Which Health Approaches and Treatments are you using?" (WHAT questionnaires in pediatric rheumatology.A sequential phased mixed methods approach was used to develop the questionnaires. A Delphi Survey of 126 experts followed by an interdisciplinary consensus conference of 14 stakeholders in CAM, general pediatrics and pediatric rheumatology was held to develop consensus on the content of the questionnaires using a nominal group technique. To determine face and content validity of the questionnaires, two groups, including (a a purposive sample of 22 children with JIA 8 to 18 years and their parents from the Children's Hospital of Eastern Ontario and the Hospital for Sick Children, and (b 21 Canadian pediatric rheumatology experts, participated in interviews. Participants were independently asked about the goal, understandability and comprehensiveness of the WHAT questionnaires, as well as the relevance of items.Consensus was reached on 17 items of the WHAT questionnaires. The domains found to be relevant were child's CAM use, factors associated with CAM use, perceived impact of CAM use, and communication about CAM. A total of 15 items in the parent proxy-report questionnaire and 13 items in the child report questionnaire showed adequate content validity.Consensus was reached by experts on the content of a pediatric CAM questionnaire. Face and content validity testing and modifications made to the WHAT questionnaires have helped ensure adequate preliminary validity for use in pediatric rheumatology. This constitutes the basis for further testing of these questionnaires in pediatric rheumatology and for adaptation to other

  6. Patient’s Knowledge and Perception Towards the use of Non-steroidal Anti-Inflammatory Drugs in Rheumatology Clinic Northern Malaysia

    Science.gov (United States)

    Sulaiman, Wahinuddin; Seung, Ong Ping; Ismail, Rosli

    2012-01-01

    Objective In Rheumatology, non-steroidal anti-inflammatory drugs (NSAIDs) has been widely prescribed and used. However, despite their clinical benefits in the management of inflammatory and degenerative joint disease, NSAIDs have considerable side effects, mostly affecting the upper gastrointestinal system, which therefore, limit their use. This study was conducted to determine the patients’ knowledge and perception regarding the used of NSAIDS. Methods A total of 120 patients who attended the rheumatology clinic Hospital, Raja Permaisuri Bainun, Malaysia, and received NSAIDs more than 3 months were interviewed irrespective of their rheumatological conditions. Patient’s knowledge and perception on the side effects of NSAIDs were recorded. Result Fifty-four percent of the patients obtained information regarding the side effect of NSAIDs either from the rheumatologist, rheumatology staff nurse or other medical staffs (75.4%). The remaining 45.8% were naive of such knowledge. Fifteen percent obtained the information by surfing the internet and 9.2% from printed media. Twenty-four (24.2%) patients, experienced indigestion and/or stomach discomfort attributed to NSAIDs used. Two patients (1.7%) had hematemesis and malena once. Conclusion This study shows that half of the patients who attended the rheumatology clinic were unaware of the side effect of NSAIDs. Available data showed that most of the knowledgeable patients are more conscience and self-educated. This study also reveals the important roles of clinicians, trained staff nurses as well as the pharmacist in providing the guidance and knowledge of any medication taken by patients. PMID:23226825

  7. Moving the boundaries of international collaboration on clinical trials and QoL: experiences in oncology and legislation within the European Parliament.

    Science.gov (United States)

    Bottomley, Andrew; Kirby, Tony; Bean, John; Walker, Julie

    2013-02-01

    The European Organisation for Research and Treatment of Cancer undertook another successful event with their third annual conference addressing quality of life matters in cancer clinical trials. More than 40 presentations were made over a 3-day period hosted at the European Parliament on 17-20 October 2012, in Brussels. The conference managed to get speakers and policy makers together to debate all the key issues in cancer clinical trials, design and reporting, including future policy and regulatory concerns. This meeting set the stage for future research and policy meetings to give greater visibility to quality of life as an outcome in clinical trials within the world of EU legislators.

  8. Evaluation of Subcutaneous Proleukin (interleukin-2) in a Randomized International Trial (ESPRIT): geographical and gender differences in the baseline characteristics of participants.

    Science.gov (United States)

    Pett, S L; Wand, H; Law, M G; Arduino, R; Lopez, J C; Knysz, B; Pereira, L C; Pollack, S; Reiss, P; Tambussi, G

    2006-01-01

    ESPRIT, is a phase III, open-label, randomized, international clinical trial evaluating the effects of subcutaneous recombinant interleukin-2 (rIL-2) plus antiretroviral therapy (ART) versus ART alone on HIV-disease progression and death in HIV-1-infected individuals with CD4+ T-cells > or =300 cells/microL. To describe the baseline characteristics of participants randomized to ESPRIT overall and by geographic location. Baseline characteristics of randomized participants were summarized by region. 4,150 patients were enrolled in ESPRIT from 254 sites in 25 countries. 41%, 27%, 16%, 11%, and 5% were enrolled in Europe, North America, South America, Asia, and Australia, respectively. The median age was 40 years, 81% were men, and 76%, 11%, and 9% were Caucasian, Asian, and African American or African, respectively. 44% of women enrolled (n = 769) were enrolled in Thailand and Argentina. Overall, 55% and 38% of the cohort acquired HIV through male homosexual and heterosexual contact, respectively. 25% had a prior history of AIDS-defining illness; Pneumocystis jirovecii pneumonia, M. tuberculosis, and esophageal candida were most commonly reported. Median nadir and baseline CD4+ T-cell counts were 199 and 458 cells/muL, respectively. 6% and 13% were hepatitis B or C virus coinfected, respectively. Median duration of antiretroviral therapy (ART) was 4.2 years; the longest median duration was in Australia (5.2 years) and the shortest was in Asia (2.3 years). 17%, 13%, and 69% of participants began ART before 1995, between 1996 and 1997, and from 1998 onward, respectively. 86% used ART from two or more ART classes, with 49% using a protease inhibitor-based regimen and 46% using a nonnucleoside reverse transcriptase inhibitor-based regimen. 78% had plasma HIV RNA below detection (ESPRIT has enrolled a diverse population of HIV-infected individuals including large populations of women and patients of African-American/African and Asian ethnicity often underrepresented in HIV

  9. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.

    LENUS (Irish Health Repository)

    Ederle, Jörg

    2010-03-20

    Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy.

  10. Open reduction and internal fixation versus casting for highly comminuted and intra-articular fractures of the distal radius (ORCHID: protocol for a randomized clinical multi-center trial

    Directory of Open Access Journals (Sweden)

    Seiler Christoph

    2011-03-01

    Full Text Available Abstract Background Fractures of the distal radius represent the most common fracture in elderly patients, and often indicate the onset of symptomatic osteoporosis. A variety of treatment options is available, including closed reduction and plaster casting, K-wire-stabilization, external fixation and open reduction and internal fixation (ORIF with volar locked plating. The latter is widely promoted by clinicians and hardware manufacturers. Closed reduction and cast stabilization for six weeks is a simple, convenient, and ubiquitously available intervention. In contrast, ORIF requires hospitalization, but allows for functional rehabilitation. Given the lack of randomized controlled trials, it remains unclear whether ORIF leads to better functional outcomes one year after injury than closed reduction and casting. Methods/Design ORCHID (Open reduction and internal fixation versus casting for highly comminuted intra-articular fractures of the distal radius is a pragmatic, randomized, multi-center, clinical trial with two parallel treatment arms. It is planned to include 504 patients in 15 participating centers throughout Germany over a three-year period. Patients are allocated by a central web-based randomization tool. The primary objective is to determine differences in the Short Form 36 (SF-36 Physical Component Score (PCS between volar locked plating and closed reduction and casting of intraarticular, comminuted distal radius fractures in patients > 65 years of age one year after the fracture. Secondary outcomes include differences in other SF-36 dimensions, the EuroQol-5D questionnaire, the Disability of the Arm, Shoulder, and Hand (DASH instrument. Also, the range of motion in the affected wrist, activities of daily living, complications (including secondary ORIF and revision surgery, as well as serious adverse events will be assessed. Data obtained during the trial will be used for later health-economic evaluations. The trial architecture

  11. Clinical Trials

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    Full Text Available ... questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical ... multi-pronged approach to Optimize our Clinical Trials Enterprise that will make our clinical trials enterprise even ...

  12. Clinical Trials

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    Full Text Available ... to-kol). This plan explains how the trial will work. The trial is led by a principal ... for the clinical trial. The protocol outlines what will be done during the clinical trial and why. ...

  13. Clinical Trials

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    Full Text Available ... take part in a clinical trial. When researchers think that a trial's potential risks are greater than ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

  14. Clinical Trials

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    Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are ... earlier than they would be in general medical practice. This is because late-phase trials have large ...

  15. Clinical Trials

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    Full Text Available ... clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a ... will be done during the clinical trial and why. Each medical center that does the study uses ...

  16. Clinical Trials

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    Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ...

  17. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

  18. 2017 American College of Rheumatology/American Association of Hip and Knee Surgeons Guideline for the Perioperative Management of Antirheumatic Medication in Patients With Rheumatic Diseases Undergoing Elective Total Hip or Total Knee Arthroplasty.

    Science.gov (United States)

    Goodman, Susan M; Springer, Bryan; Guyatt, Gordon; Abdel, Matthew P; Dasa, Vinod; George, Michael; Gewurz-Singer, Ora; Giles, Jon T; Johnson, Beverly; Lee, Steve; Mandl, Lisa A; Mont, Michael A; Sculco, Peter; Sporer, Scott; Stryker, Louis; Turgunbaev, Marat; Brause, Barry; Chen, Antonia F; Gililland, Jeremy; Goodman, Mark; Hurley-Rosenblatt, Arlene; Kirou, Kyriakos; Losina, Elena; MacKenzie, Ronald; Michaud, Kaleb; Mikuls, Ted; Russell, Linda; Sah, Alexander; Miller, Amy S; Singh, Jasvinder A; Yates, Adolph

    2017-09-01

    and based on low- or moderate-quality evidence. This guideline should help decision-making by clinicians and patients regarding perioperative antirheumatic medication management at the time of elective THA or TKA. These conditional recommendations reflect the paucity of high-quality direct randomized controlled trial data. Copyright © 2017 Elsevier Inc and the American College of Rheumatology. Published by Elsevier Inc. All rights reserved.

  19. Clinical Trials

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    Full Text Available ... Trial Protocol Each clinical trial has a master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The trial ... clinical trial; and detailed information about the treatment plan. Eligibility Criteria A clinical trial's protocol describes what ...

  20. Uveitis Events During Adalimumab, Etanercept, and Methotrexate Therapy in Juvenile Idiopathic Arthritis: Data From the Biologics in Pediatric Rheumatology Registry.

    Science.gov (United States)

    Foeldvari, Ivan; Becker, Ingrid; Horneff, Gerd

    2015-11-01

    Uveitis is a major extraarticular quality of life-restricting manifestation of juvenile idiopathic arthritis (JIA). The aim of the study is to describe the occurrence of uveitis in JIA patients receiving tumor necrosis factor inhibitors or methotrexate (MTX). Patients' characteristics, treatment, and the reported first occurrence of uveitis as an adverse event were searched in the Biologics in Pediatric Rheumatology Registry. The rates per exposed patients, exposure time, and time until event were calculated. Uveitis was reported as an adverse event in 75 of 3,467 patients; 51 of 2,844 patients were receiving MTX, 37 of 1,700 patients were receiving etanercept, and 13 of 364 patients were receiving adalimumab. Patients with uveitis were younger (mean ± SD age 4.6 ± 4.2 versus 7.4 ± 4.5 years; P uveitis diagnosis before starting treatment more often had a uveitis event (n = 28, 8.4%; OR 8.5, P uveitis event occurred: 11 while taking MTX (3.2 per 1,000 patient-years), 2 while taking etanercept monotherapy (1.9 per 1,000 patient-years), and 3 while taking etanercept and MTX combination (0.9 per 1,000 patient-years). A new uveitis event occurred early in the disease course after a median disease duration of 1.5 years (interquartile range [IQR] 1.3-3.8) while taking etanercept and 1.8 years (IQR 1.8-2.1) for the MTX cohort. A recurrent uveitis event was reported after a disease duration of 7.6 years (IQR 4.3-10.0) in the etanercept cohort and 4.8 years (IQR 1.0-5.8) in the MTX cohort. Univariate analysis showed that MTX, but not etanercept or adalimumab, led to a lower rate of uveitis. Patients with a history of uveitis had higher risks for uveitis events while taking both etanercept and adalimumab. Methotrexate turned out to be protective. Few patients developed a first uveitis event while taking etanercept, while the rate is comparable to that with MTX. Uveitis may not be attributed to be an adverse drug reaction to etanercept. © 2015, American

  1. The Spanish version of the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for fibromyalgia: reliability and validity assessment.

    Science.gov (United States)

    Casanueva, Benigno; García-Fructuoso, Ferrán; Belenguer, Rafael; Alegre, Cayetano; Moreno-Muelas, José V; Hernández, José L; Pina, Tinitario; González-Gay, Miguel Á

    2016-01-01

    To investigate the reliability and validity of the Spanish version of the 2010 American College of Rheumatology (ACR) Preliminary Diagnostic Criteria for Fibromyalgia (FM) in patients with chronic pain. The 2010 ACR Preliminary Diagnostic Criteria for FM were adapted to a Spanish version following the guidelines of the Rheumatology Spanish Society Study Group of FM. Based on the 1990 ACR classi cation criteria for FM, patients with chronic pain were initially divided into two groups: a FM group and another group of non-FM individuals. Patients from the FM group were evaluated by tender points (TP) examination, Fibromyalgia Impact Questionnaire (FIQ), Widespread Pain Index (WPI), and Symptom Severity Scale (SSS). The non-FM (control) group included patients with rheumatoid arthritis (RA) and osteoarthritis (OA). They were evaluated by WPI and SSS. We included 1,169 patients divided into two groups: FM group (n=803; 777 women and 26 men) and non-FM group (n= 366; 147 patients with RA, and 219 with OA). The median value of TP and FIQ in the FM group was 16 and 74 respectively. The preliminary 2010 ACR criteria were met by 665 (82.8%) FM patients and by 112 (30.6%) patients from the non-FM group (pFIQ (p<0.0001), WPI (p<0.0001) and SSS (p<0.0001) were observed when FM patients fulfilling the 2010 ACR criteria were compared with the remaining FM patients who did not fulfill these criteria. Sensitivity of the Spanish version of the 2010 ACR criteria was 85.6% (95%CI: 83.1-88.1), speci city 73.2% (95%CI: 68.4-78), positive predictive value 87.7% (95%CI: 85.3-90.1) and negative predictive value 69.4% (95%CI: 64.5-74.2). Our results indicate that the 2010 ACR Preliminary Diagnostic Criteria for FM may be useful to establish a diagnosis of FM in Spanish individuals with chronic pain.

  2. The BIG 2.04 MRC/EORTC SUPREMO Trial: pathology quality assurance of a large phase 3 randomised international clinical trial of postmastectomy radiotherapy in intermediate-risk breast cancer.

    Science.gov (United States)

    Thomas, J S; Hanby, A M; Russell, N; van Tienhoven, G; Riddle, K; Anderson, N; Cameron, D A; Bartlett, J M S; Piper, T; Cunningham, C; Canney, P; Kunkler, I H

    2017-05-01

    SUPREMO is a phase 3 randomised trial evaluating radiotherapy post-mastectomy for intermediate-risk breast cancer. 1688 patients were enrolled from 16 countries between 2006 and 2013. We report the results of central pathology review carried out for quality assurance. A single recut haematoxylin and eosin (H&E) tumour section was assessed by one of two reviewing pathologists, blinded to the originally reported pathology and patient data. Tumour type, grade and lymphovascular invasion were reviewed to assess if they met the inclusion criteria. Slides from potentially ineligible patients on central review were scanned and reviewed online together by the two pathologists and a consensus reached. A subset of 25 of these cases was double-reported independently by the pathologists prior to the online assessment. The major contributors to the trial were the UK (75%) and the Netherlands (10%). There is a striking difference in lymphovascular invasion (LVi) rates (41.6 vs. 15.1% (UK); p = grade 3 carcinomas (54.0 vs. 42.0% (UK); p = grade and/or lymphovascular invasion status. Following online consensus review, this fell to 70 cases (16.3% of N- cases, 4.1% of all cases). These data have important implications for the design, powering and interpretation of outcomes from this and future clinical trials. If critical pathology criteria are determinants for trial entry, serious consideration should be given to up-front central pathology review.

  3. Ibrutinib for patients with rituximab-refractory Waldenström's macroglobulinaemia (iNNOVATE): an open-label substudy of an international, multicentre, phase 3 trial.

    Science.gov (United States)

    Dimopoulos, Meletios A; Trotman, Judith; Tedeschi, Alessandra; Matous, Jeffrey V; Macdonald, David; Tam, Constantine; Tournilhac, Olivier; Ma, Shuo; Oriol, Albert; Heffner, Leonard T; Shustik, Chaim; García-Sanz, Ramón; Cornell, Robert F; de Larrea, Carlos Fernández; Castillo, Jorge J; Granell, Miquel; Kyrtsonis, Marie-Christine; Leblond, Veronique; Symeonidis, Argiris; Kastritis, Efstathios; Singh, Priyanka; Li, Jianling; Graef, Thorsten; Bilotti, Elizabeth; Treon, Steven; Buske, Christian

    2017-02-01

    In the era of widespread rituximab use for Waldenström's macroglobulinaemia, new treatment options for patients with rituximab-refractory disease are an important clinical need. Ibrutinib has induced durable responses in previously treated patients with Waldenström's macroglobulinaemia. We assessed the efficacy and safety of ibrutinib in a population with rituximab-refractory disease. This multicentre, open-label substudy was done at 19 sites in seven countries in adults aged 18 years and older with confirmed Waldenström's macroglobulinaemia, refractory to rituximab and requiring treatment. Disease refractory to the last rituximab-containing therapy was defined as either relapse less than 12 months since last dose of rituximab or failure to achieve at least a minor response. Key exclusion criteria included: CNS involvement, a stroke or intracranial haemorrhage less than 12 months before enrolment, clinically significant cardiovascular disease, hepatitis B or hepatitis C viral infection, and a known bleeding disorder. Patients received oral ibrutinib 420 mg once daily until progression or unacceptable toxicity. The substudy was not prospectively powered for statistical comparisons, and as such, all the analyses are descriptive in nature. This study objectives were the proportion of patients with an overall response, progression-free survival, overall survival, haematological improvement measured by haemoglobin, time to next treatment, and patient-reported outcomes according to the Functional Assessment of Cancer Therapy-Anemia (FACT-An) and the Euro Qol 5 Dimension Questionnaire (EQ-5D-5L). All analyses were per protocol. The study is registered at ClinicalTrials.gov, number NCT02165397, and follow-up is ongoing but enrolment is complete. Between Aug 18, 2014, and Feb 18, 2015, 31 patients were enrolled. Median age was 67 years (IQR 58-74); 13 (42%) of 31 patients had high-risk disease per the International Prognostic Scoring System Waldenstr

  4. Biological therapy with TNF-inhibitors in pediatric rheumatology. Review of the litterature and personal experience

    Directory of Open Access Journals (Sweden)

    F. Fantini

    2011-09-01

    Full Text Available The therapeutic approach to JIA is sometimes very troublesome and progression to erosive polyarthritis may occur in all JIA categories. Only Methotrexate has shown efficacy and safety in a large controlled trial. Nevertheless, in many cases, drug resistance or intolerance has led to try other therapeutic options, with still debatable results. Therefore, there has been space, in the last few years, for new therapies as the TNF-inhibitors. This therapeutic approach has shown a dramatic clinical benefit in active polyarticular refractory JIA: the rate and rapidity of response have exceeded those of all other studied DMARDs. Preliminary data show that they are efficacious also for other pediatric rheumatic disease (spondyloarthropathies, autoimmune uveitis, dermatomyositis, Kawasaki syndrome and some auto- inflammatory diseases. TNF-inhibitors in JIA have demonstrated a favourable benefit-to-risk profile. However, as their use has increased worldwide, some unusual, usually not serious, adverse events have emerged. Severe infections, including TB, and deaths have been reported. Long-lasting active disease, systemic disease, concurrent and previous immunosuppressive therapies, all contribute to risk of infection and other serious AEs. Given the evidence that TNF has a primary role in the pathogenesis of JIA, particularly in joint destruction, neutralizing this cytokine early, within the window of opportunity, could halt or delay progression of joint damage and debilitating consequences of the disease. Thus, for JIA patients whose disease is not quickly controlled with MTX, TNF blockers may be considered as first-line treatment, although long-term safety data still need to be established.

  5. Open reduction and internal fixation versus casting for highly comminuted and intra-articular fractures of the distal radius (ORCHID): protocol for a randomized clinical multi-center trial.

    Science.gov (United States)

    Bartl, Christoph; Stengel, Dirk; Bruckner, Thomas; Rossion, Inga; Luntz, Steffen; Seiler, Christoph; Gebhard, Florian

    2011-03-22

    Fractures of the distal radius represent the most common fracture in elderly patients, and often indicate the onset of symptomatic osteoporosis. A variety of treatment options is available, including closed reduction and plaster casting, K-wire-stabilization, external fixation and open reduction and internal fixation (ORIF) with volar locked plating. The latter is widely promoted by clinicians and hardware manufacturers. Closed reduction and cast stabilization for six weeks is a simple, convenient, and ubiquitously available intervention. In contrast, ORIF requires hospitalization, but allows for functional rehabilitation.Given the lack of randomized controlled trials, it remains unclear whether ORIF leads to better functional outcomes one year after injury than closed reduction and casting. ORCHID (Open reduction and internal fixation versus casting for highly comminuted intra-articular fractures of the distal radius) is a pragmatic, randomized, multi-center, clinical trial with two parallel treatment arms. It is planned to include 504 patients in 15 participating centers throughout Germany over a three-year period. Patients are allocated by a central web-based randomization tool.The primary objective is to determine differences in the Short Form 36 (SF-36) Physical Component Score (PCS) between volar locked plating and closed reduction and casting of intraarticular, comminuted distal radius fractures in patients > 65 years of age one year after the fracture. Secondary outcomes include differences in other SF-36 dimensions, the EuroQol-5D questionnaire, the Disability of the Arm, Shoulder, and Hand (DASH) instrument. Also, the range of motion in the affected wrist, activities of daily living, complications (including secondary ORIF and revision surgery), as well as serious adverse events will be assessed. Data obtained during the trial will be used for later health-economic evaluations. The trial architecture involves a central statistical unit, an independent

  6. Systemic lupus erythematosus in Spanish males: a study of the Spanish Rheumatology Society Lupus Registry (RELESSER) cohort.

    Science.gov (United States)

    Riveros Frutos, A; Casas, I; Rúa-Figueroa, I; López-Longo, F J; Calvo-Alén, J; Galindo, M; Fernández-Nebro, A; Pego-Reigosa, J M; Olivé Marqués, A

    2017-06-01

    Objective The objective of this study was to describe the demographic, clinical, and immunological manifestations of systemic lupus erythematosus (SLE) in male patients. Methods A cross-sectional, multicenter study was carried out of 3651 patients (353 men, 9.7%, and 3298 women, 90.2%) diagnosed with SLE, included in the Spanish Rheumatology Society SLE Registry (RELESSER). Results Mean ages (18-92 years) of symptom onset were 37 (SD 17) years (men) and 32 (SD 14) years (women). Male/female ratio was 1/9. Age of onset of symptoms and age at diagnosis were higher in men than in women ( p lupus nephritis was more common in men, being present in 155 (44.8%) of males versus 933 (29%) of females ( p  50 years had a higher mortality (odds ratios 3.6 and 2.1, respectively). Furthermore, SLE patients who developed pulmonary hemorrhage, pulmonary hypertension, psychiatric involvement, complement deficiency, and hemophagocytic syndrome also had higher mortality, regardless of gender. Conclusion Patients with SLE over the age of 50 years have an increased risk of mortality. In Caucasians, age at diagnosis and symptom onset is higher in men than in women. The diagnostic delay is shorter in men. Male SLE patients present more cardiovascular comorbidities, and also more serositis, adenopathies, splenomegaly, renal involvement, convulsion, thrombosis, and lupus anticoagulant positivity than women.

  7. A randomized clinical trial evaluating plasma rich in growth factors (PRGF-Endoret) versus hyaluronic acid in the short-term treatment of symptomatic knee osteoarthritis.

    Science.gov (United States)

    Sánchez, Mikel; Fiz, Nicolás; Azofra, Juan; Usabiaga, Jaime; Aduriz Recalde, Enmanuel; Garcia Gutierrez, Antonio; Albillos, Javier; Gárate, Ramón; Aguirre, Jose Javier; Padilla, Sabino; Orive, Gorka; Anitua, Eduardo

    2012-08-01

    This multicenter, double-blind clinical trial evaluated and compared the efficacy and safety of PRGF-Endoret (BTI Biotechnology Institute, Vitoria-Gasteiz, Spain), an autologous biological therapy for regenerative purposes, versus hyaluronic acid (HA) as a short-term treatment for knee pain from osteoarthritis. We randomly assigned 176 patients with symptomatic knee osteoarthritis to receive infiltrations with PRGF-Endoret or with HA (3 injections on a weekly basis). The primary outcome measure was a 50% decrease in knee pain from baseline to week 24. As secondary outcomes, we also assessed pain, stiffness, and physical function using the Western Ontario and McMaster Universities Osteoarthritis Index; the rate of response using the criteria of the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI); and safety. The mean age of the patients was 59.8 years, and 52% were women. Compared with the rate of response to HA, the rate of response to PRGF-Endoret was 14.1 percentage points higher (95% confidence interval, 0.5 to 27.6; P = .044). Regarding the secondary outcome measures, the rate of response to PRGF-Endoret was higher in all cases, although no significant differences were reached. Adverse events were mild and evenly distributed between the groups. Plasma rich in growth factors showed superior short-term results when compared with HA in a randomized controlled trial, with a comparable safety profile, in alleviating symptoms of mild to moderate osteoarthritis of the knee. Level I, randomized controlled multicenter trial. Copyright © 2012 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  8. Wait times to rheumatology care for patients with rheumatic diseases: a data linkage study of primary care electronic medical records and administrative data.

    Science.gov (United States)

    Widdifield, Jessica; Bernatsky, Sasha; Thorne, J Carter; Bombardier, Claire; Jaakkimainen, R Liisa; Wing, Laura; Paterson, J Michael; Ivers, Noah; Butt, Debra; Lyddiatt, Anne; Hofstetter, Catherine; Ahluwalia, Vandana; Tu, Karen

    2016-01-01

    The Wait Time Alliance recently established wait time benchmarks for rheumatology consultations in Canada. Our aim was to quantify wait times to primary and rheumatology care for patients with rheumatic diseases. We identified patients from primary care practices in the Electronic Medical Record Administrative data Linked Database who had referrals to Ontario rheumatologists over the period 2000-2013. To assess the full care pathway, we identified dates of symptom onset, presentation in primary care and referral from electronic medical records. Dates of rheumatologist consultations were obtained by linking with physician service claims. We determined the duration of each phase of the care pathway (symptom onset to primary care encounter, primary care encounter to referral, and referral to rheumatologist consultation) and compared them with established benchmarks. Among 2430 referrals from 168 family physicians, 2015 patients (82.9%) were seen by 146 rheumatologists within 1 year of referral. Of the 2430 referrals, 2417 (99.5%) occurred between 2005 and 2013. The main reasons for referral were osteoarthritis (32.4%) and systemic inflammatory rheumatic diseases (30.6%). Wait times varied by diagnosis and geographic region. Overall, the median wait time from referral to rheumatologist consultation was 74 (interquartile range 27-101) days; it was 66 (interquartile range 18-84) days for systemic inflammatory rheumatic diseases. Wait time benchmarks were not achieved, even for the most urgent types of referral. For systemic inflammatory rheumatic diseases, most of the delays occurred before referral. Rheumatology wait times exceeded established benchmarks. Targeted efforts are needed to promote more timely access to both primary and rheumatology care. Routine linkage of electronic medical records with administrative data may help fill important gaps in knowledge about waits to primary and specialty care.

  9. Patient’s Knowledge and Perception Towards the use of Non-steroidal Anti-Inflammatory Drugs in Rheumatology Clinic Northern Malaysia

    Directory of Open Access Journals (Sweden)

    Wahinuddin Sulaiman

    2012-11-01

    Full Text Available Objective: In Rheumatology, non-steroidal anti-inflammatory drugs (NSAIDs has been widely prescribed and used. However, despite their clinical benefits in the management of inflammatory and degenerative joint disease, NSAIDs have considerable side effects, mostly affecting the upper gastrointestinal system, which therefore, limit their use. This study was conducted to determine the patients’ knowledge and perception regarding the used of NSAIDS.Methods: A total of 120 patients who attended the rheumatology clinic Hospital, Raja Permaisuri Bainun, Malaysia, and received NSAIDs more than 3 months were interviewed irrespective of the irrheumatological conditions. Patient’s knowledge and perception on the side effects of NSAIDs were recorded.Result: Fifty-four percent of the patients obtained information regarding the side effect of NSAIDs either from the rheumatologist, rheumatology staff nurse or other medical staffs (75.4%. The remaining 45.8% were naive of such knowledge. Fifteen percent obtained the information by surfing the internet and 9.2% from printed media. Twenty-four (24.2% patients, experiencedin digestion and/or stomach discomfort attributed to NSAIDsused. Two patients (1.7% had hematemesis and malena once.Conclusion: This study shows that half of the patients who attended the rheumatology clinic were unaware of the side effect of NSAIDs. Available data showed that most of the knowledgeable patients are more conscience and self-educated. This study also reveals the important roles of clinicians, trained staff nurses as well as the pharmacist in providing the guidance and knowledge of any medication taken by patients.

  10. EULAR recommendations for the management of knee osteoarthritis: report of a task force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT)

    NARCIS (Netherlands)

    Pendleton, A.; Arden, N.; Dougados, M.; Doherty, M.; Bannwarth, B.; Bijlsma, J. W.; Cluzeau, F.; Cooper, C.; Dieppe, P. A.; Günther, K. P.; Hauselmann, H. J.; Herrero-Beaumont, G.; Kaklamanis, P. M.; Leeb, B.; Lequesne, M.; Lohmander, S.; Mazieres, B.; Mola, E. M.; Pavelka, K.; Serni, U.; Swoboda, B.; Verbruggen, A. A.; Weseloh, G.; Zimmermann-Gorska, I.

    2000-01-01

    Osteoarthritis (OA) is the most common joint disease encountered throughout Europe. A task force for the EULAR Standing Committee for Clinical Trials met in 1998 to determine the methodological and logistical approach required for the development of evidence based guidelines for treatment of knee

  11. EULAR recommendations for the management of knee osteoarthritis. Report of a task force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT)

    NARCIS (Netherlands)

    Pendleton, A.; Arden, N.; Dougados, M.; Doherty, M.; Bannwarth, B.; Bijlsma, J.; Cluzeau, F.; Cooper, C.; Dieppe, P.; Gunther, K. P.; Hauselmann, H.; Herrero-Beaumont, G.; Kaklamanis, P.; Leeb, B.; Littlejohn, M. L. P.; Lohmander, S.; Mazieres, B.; Mola, E. M.; Pavelka, K.; Serni, U.; Swoboda, B.; Verbruggen, G.; Weseloh, G.; Zimmermann-Gorska, I.

    2002-01-01

    Background Osteoarthritis (OA) is the most common joint disease encountered throughout Europe. A task force for the EULAR standing committee for clinical trials met in 1998 to determine the methodological and logistical approach required for the development of evidence-based guidelines for treatment

  12. Crack sizing by the time-of-flight diffraction method, in the light of recent international round-robin trials, (UKAEA, DDT and PISC II)

    International Nuclear Information System (INIS)

    Curtis, G.J.

    1987-01-01

    In 1980-81, Harwell developed a mini-computer controlled multi-probe defect detection and sizing system based on the ultrasonic time-of-flight/diffraction principle introduced by Silk. This system proved to be capable of fully automatic data collection from the PWR girth-weld simulation Plates 1 and 2 in the Defect Detection Trials of 1981-82. The speed of collection and subsequent analysis was such that a report on the defects found could be filed within 48 hours. The mode of operation adopted simulated minimum time of access to the defects, and was intended to define that dimension of a defect which has greatest significance, i.e. the through-thickness dimension. In 1984, for the PISC II Trial, the approach adopted changed to emphasize the three-dimensional location and sizing capabilities of the time-of-flight/diffraction method. Data collection and analysis became highly interactive and the mode of operation simulated NDE at the manufacturing stage of a pressure vessel. The purpose of this paper is to indicate the defect through-thickness sizing capability of TOFD achieved in the 1981-82 Defect Detection Trials and the defect mapping capability achieved in the 1984 PISC II Trial

  13. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3) : final results of an international, open-label, multicentre, randomised, phase 3 trial

    NARCIS (Netherlands)

    de Boer, Stephanie M.; Powell, Melanie E.; Mileshkin, Linda; Katsaros, Dionyssios; Bessette, Paul; Haie-Meder, Christine; Ottevanger, Petronella B.; Ledermann, Jonathan A.; Khaw, Pearly; Colombo, Alessandro; Fyles, Anthony; Baron, Marie-Helene; Jurgenliemk-Schulz, Ina M.; Kitchener, Henry C.; Nijman, Hans W.; Wilson, Godfrey; Brooks, Susan; Carinelli, Silvestro; Provencher, Diane; Hanzen, Chantal; Lutgens, Ludy C. H. W.; Smit, Vincent T. H. B. M.; Singh, Naveena; Do, Viet; D'Amico, Romerai; Nout, Remi A.; Feeney, Amanda; Verhoeven-Adema, Karen W.; Putter, Hein; Creutzberg, Carien L.

    Background Although women with endometrial cancer generally have a favourable prognosis, those with high-risk disease features are at increased risk of recurrence. The PORTEC-3 trial was initiated to investigate the benefit of adjuvant chemotherapy during and after radiotherapy (chemoradiotherapy)

  14. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3) : final results of an international, open-label, multicentre, randomised, phase 3 trial

    NARCIS (Netherlands)

    de Boer, Stephanie M.; Powell, Melanie E.; Mileshkin, Linda; Katsaros, Dionyssios; Bessette, Paul; Haie-Meder, Christine; Ottevanger, Petronella B.; Ledermann, Jonathan A.; Khaw, Pearly; Colombo, Alessandro; Fyles, Anthony; Baron, Marie Helene; Jürgenliemk-Schulz, Ina M.; Kitchener, Henry C.; Nijman, Hans W.; Wilson, Godfrey; Brooks, Susan; Carinelli, Silvestro; Provencher, Diane; Hanzen, Chantal; Lutgens, Ludy C.H.W.; Smit, Vincent T.H.B.M.; Singh, Naveena; Do, Viet; D'Amico, Romerai; Nout, Remi A.; Feeney, Amanda; Verhoeven-Adema, Karen W.; Putter, Hein; Creutzberg, Carien L.; McCormack, Mary; Whitmarsh, Karen; Allerton, Rozenn; Gregory, Deborah; Symonds, Paul; Hoskin, Peter J.; Adusumalli, Madhavi; Anand, Anjana; Wade, Robert; Stewart, Alexandra; Taylor, Wendy; Kruitwagen, Roy F.P.M.; Hollema, Harry; Pras, Elizabeth; Snyers, An; Stalpers, Lukas; Jobsen, Jan J.; Slot, Annerie; Mens, Jan Willem M.; Stam, Tanja C.; Van Triest, Baukelien; Van der Steen - Banasik, Elzbieta M.; De Winter, Karin A.J.; Quinn, Michael A.; Kolodziej, Ilka; Pyman, Jan; Johnson, Carol; Capp, Anne; Fossati, Roldano; Gribaudo, Sergio; Lissoni, Andrea A.; Ferrero, Annamaria; Artioli, Grazia; Davidson, Cathy; McLachlin, C. Meg; Ghatage, Prafull; Rittenberg, Paula V.C.; Souhami, Luis; Thomas, Gillian; Duvillard, Pierre; Berton-Rigaud, Dominique; Tubiana-Mathieu, Nicole

    2018-01-01

    Background: Although women with endometrial cancer generally have a favourable prognosis, those with high-risk disease features are at increased risk of recurrence. The PORTEC-3 trial was initiated to investigate the benefit of adjuvant chemotherapy during and after radiotherapy (chemoradiotherapy)

  15. Toward a Global Consensus on Outcome Measures for Clinical Trials in Tinnitus: Report From the First International Meeting of the COMiT Initiative, November 14, 2014, Amsterdam, The Netherlands

    Directory of Open Access Journals (Sweden)

    Deborah A. Hall

    2015-04-01

    Full Text Available In Europe alone, over 70 million people experience tinnitus; for seven million people, it creates a debilitating condition. Despite its enormous socioeconomic relevance, progress in successfully treating the condition is somewhat limited. The European Union has approved funding to create a pan-European tinnitus research collaboration network (2014–2018. The goal of one working group is to establish an international standard for outcome measurements in clinical trials of tinnitus. Importantly, this would enhance tinnitus research by informing sample-size calculations, enabling meta-analyses, and facilitating the identification of tinnitus subtypes, ultimately leading to improved treatments. The first meeting followed a workshop on “Agreed Standards for Measurement: An International Perspective” with invited talks on clinimetrics and existing international initiatives to define core sets for outcome measurements in hearing loss (International classification of functioning, disability, and health core sets for hearing loss and eczema (Harmonizing outcome measures for eczema. Both initiatives have taken an approach that clearly distinguishes the specification of what to measure from that of how to measure it. Meeting delegates agreed on taking a step-wise roadmap for which the first output would be a consensus on what outcome domains are essential for all trials. The working group seeks to embrace inclusivity and brings together clinicians, tinnitus researchers, experts on clinical research methodology, statisticians, and representatives of the health industry. People who experience tinnitus are another important participant group. This meeting report is a call to those stakeholders across the globe to actively participate in the initiative.

  16. Management of patients with rheumatoid arthritis in Latin America: a consensus position paper from Pan-American League of Associations of Rheumatology and Grupo Latino Americano De Estudio De Artritis Reumatoide.

    Science.gov (United States)

    Massardo, Loreto; Suárez-Almazor, María E; Cardiel, Mario H; Nava, Arnulfo; Levy, Roger A; Laurindo, Ieda; Soriano, Enrique R; Acevedo-Vázquez, Eduardo; Millán, Alberto; Pineda-Villaseñor, Carlos; Galarza-Maldonado, Claudio; Caballero-Uribe, Carlo V; Espinosa-Morales, Rolando; Pons-Estel, Bernardo A

    2009-06-01

    A consensus meeting of representatives of 18 Latin-American and Caribbean countries gathered in Reñaca, Chile, for 2 days to identify problems and provide recommendations for the care of patients with rheumatoid arthritis (RA) in Latin America, a region where poverty and other health priorities make the efforts to provide effective and high quality care difficult. This report includes recommendations for health professionals, patients, and health authorities in Latin America, with an emphasis on education and therapeutic issues. Fifty-one rheumatologists (list available only online on the JCR website) from 18 Latin-American and Caribbean countries with a special interest in RA participated in the consensus meeting. Participants were experts identified and appointed by the National Societies of Rheumatology affiliated with the Pan-American League of Associations for Rheumatology (PANLAR) and by the Grupo Latino Americano De Estudio de Artritis Reumatoide (GLADAR)-an independent group of Latin American rheumatologist researchers were also invited to the meeting. Eight topics were identified as priorities: patient, community and allied health professional education, health policy and decision making, programs for early detection and appropriate treatment of RA, role of classic disease modifying antirheumatic drugs (DMARDs), role of biologic therapy, and drug safety surveillance. To reach consensus, a survey with questions relevant to the topic of interest was sent to all participants before the meeting. During a 2 day meeting, the answers of the survey were reviewed and discussed by each group, with final recommendations on action items. The specific topic of the survey was answered by 86% of the participants and 68% of them answered the entire survey. It was agreed that RA and rheumatic diseases which are currently not but should be public health priorities in Latin America, because of their prevalence and impact on quality of life. Strategic areas identified as

  17. Preventing recurrence of endometriosis by means of long-acting progestogen therapy (PRE-EMPT): report of an internal pilot, multi-arm, randomised controlled trial incorporating flexible entry design and adaption of design based on feasibility of recruitment.

    Science.gov (United States)

    Middleton, Lee J; Daniels, Jane P; Weckesser, Annalise; Bhattacharya, Siladitya

    2017-03-11

    Endometriosis is associated with the growth of endometrium in ectopic sites mainly within the pelvis. This results in inflammation and scarring, causing pain and impaired quality of life. Endometriotic lesions can be excised or ablated surgically, but the risk of recurrence is high. A Heath Technology Assessment commissioning call in 2011 sought applications for trials aimed at evaluating long-term effectiveness of postoperative, long-acting, reversible contraceptives (LARCs) in preventing recurrence of endometriosis. A survey of gynaecologists indicated that there was no consensus about which LARC (Levonorgestrel Intrauterine System (LNG-IUS) or depot medroxyprogesterone acetate injection (DMPA)) or comparator (combined oral contraceptive pill (COCP) or no treatment) should be evaluated. Hence, we designed a 'flexible-entry' internal pilot to assess whether a four-arm trial was feasible including a possible design adaption based on pilot findings. In this pilot, women could be randomised to two, three or four treatment options provided that one was a LARC and one was a non-LARC. An assessment of feasibility based on recruitment to these options and a revised substantive trial design was considered by an independent oversight committee. The study ran for 1 year from April 2014 and 77 women were randomised. Only 5 (6%) women accepted randomisation to all groups, with 63 (82%) having a LARC preference and 55 (71%) a non-LARC preference. Four-way and three-way designs were ruled out with a two-way LARC versus COCP design, stratified by prerandomisation choice of LARC and optional subrandomisation to LNG-IUS versus DMPA considered a feasible substantive study. Multi-arm studies are potentially efficient as they can answer multiple questions simultaneously but are difficult to recruit to if there are strong patient or clinician preferences. A flexible approach to randomisation in a pilot phase can be used to assess feasibility of such studies and modify a trial design

  18. Telemedicine and other care models in pediatric rheumatology: an exploratory study of parents' perceptions of barriers to care and care preferences.

    Science.gov (United States)

    Bullock, Danielle R; Vehe, Richard K; Zhang, Lei; Correll, Colleen K

    2017-07-11

    The United States pediatric rheumatology workforce is committed to a mission of providing children access to pediatric rheumatology care. With a limited number and distribution of pediatric rheumatologists, telemedicine has been proposed as one way to meet this mission, yet the adoption of this modality has been slower than expected. The purpose of this study was to explore the parent perspective on barriers to accessing pediatric rheumatology care and to explore the acceptability of telemedicine and other alternative care models. Over a period of six weeks, all new and return English-speaking parents/guardians of patients visiting a single center were offered an opportunity to complete a survey which assessed barriers to care and interest in alternative models of care. Responses were analyzed using descriptive statistics. Survey response rate was 72% (159/221). Twenty-eight percent (45/159) traveled more than three hours to the pediatric rheumatology clinic, and 43% (65/152) reported travel as inconvenient. An overwhelming majority of respondents (95%, 144/152) reported a preference for in-person visits over the option of telemedicine. This preference was similar regardless of whether respondents reported travel to the clinic as inconvenient vs convenient (inconvenient 92%, 60/65; convenient 97%, 84/87; p = 0.2881) and despite those reporting travel as inconvenient also reporting greater difficulty with several barriers to care. Those familiar with telemedicine were more likely to report a preference for telemedicine over in-person visits (27%, 3/11 vs 3%, 4/140; p = 0.0087). The option of an outreach clinic was acceptable to a majority (63%, 97/154); however, adult rheumatology and shared-care options were less acceptable (22%, 35/156 and 34%, 53/156 respectively). Among survey respondents, in-person visits were preferred over the option of telemedicine, even when travel was noted to be inconvenient. Telemedicine familiarity increased its acceptability

  19. Prospective risk of rheumatologic disease associated with occupational exposure in a cohort of male construction workers.

    Science.gov (United States)

    Blanc, Paul D; Järvholm, Bengt; Torén, Kjell

    2015-10-01

    The association between occupational exposure and autoimmune disease is well recognized for silica, and suspected for other inhalants. We used a large cohort to estimate the risks of rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, and dermatomyositis associated with silica and other occupational exposures. We analyzed data for male Swedish construction industry employees. Exposure was defined by a job-exposure matrix for silica and for other inorganic dusts; those with other job-exposure matrix exposures but not to either of the 2 inorganic dust categories were excluded. National hospital treatment data were linked for International Classification of Diseases, 10(th) Revision-coded diagnoses of rheumatoid arthritis (seronegative and positive), systemic lupus erythematosus, systemic sclerosis, and dermatomyositis. The 2 occupational exposures were tested as independent predictors of prospective hospital-based treatment for these diagnoses using age-adjusted Poisson multivariable regression analyses to calculate relative risk (RR). We analyzed hospital-based treatment data (1997 through 2010) for 240,983 men aged 30 to 84 years. There were 713 incident cases of rheumatoid arthritis (467 seropositive, 195 seronegative, 51 not classified) and 128 cases combined for systemic lupus erythematosus, systemic sclerosis, and dermatomyositis. Adjusted for smoking and age, the 2 occupational exposures (silica and other inorganic dusts) were each associated with increased risk of rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, and dermatomyositis combined: RR 1.39 (95% confidence interval [CI], 1.17-1.64) and RR 1.31 (95% CI, 1.11-1.53), respectively. Among ever smokers, both silica and other inorganic dust exposure were associated with increased risk of rheumatoid arthritis (RRs 1.36; 95% CI, 1.11-1.68 and 1.42; 95% CI, 1.17-1.73, respectively), while among never smokers, neither exposure was associated with statistically

  20. Results of a Quality Assurance Review of External Beam Radiation Therapy in the International Society of Paediatric Oncology (Europe) Neuroblastoma Group's High-risk Neuroblastoma Trial: A SIOPEN Study

    International Nuclear Information System (INIS)

    Gaze, Mark N.; Boterberg, Tom; Dieckmann, Karin; Hörmann, Marcus; Gains, Jennifer E.; Sullivan, Kevin P.; Ladenstein, Ruth

    2013-01-01

    Purpose: Radiation therapy is important for local control in neuroblastoma. This study reviewed the compliance of plans with the radiation therapy guidelines of the International Society of Paediatric Oncology (Europe) Neuroblastoma Group (SIOPEN) High-Risk Trial protocol. Methods and Materials: The SIOPEN trial central electronic database has sections to record diagnostic imaging and radiation therapy planning data. Individual centers may upload data remotely, but not all centers involved in the trial chose to use this system. A quality scoring system was devised based on how well the radiation therapy plan matched the protocol guidelines, to what extent deviations were justified, and whether adverse effects may result. Central review of radiation therapy planning was undertaken retrospectively in 100 patients for whom complete diagnostic and treatment sets were available. Data were reviewed and compared against protocol guidelines by an international team of radiation oncologists and radiologists. For each patient in the sample, the central review team assigned a quality assurance score. Results: It was found that in 48% of patients there was full compliance with protocol requirements. In 29%, there were deviations for justifiable reasons with no likely long-term adverse effects resulting. In 5%, deviations had occurred for justifiable reasons, but that might result in adverse effects. In 1%, there was a deviation with no discernible justification, which would not lead to long-term adverse events. In 17%, unjustified deviations were noted, with a risk of an adverse outcome resulting. Conclusions: Owing to concern over the proportion of patients in whom unjustified deviations were observed, a protocol amendment has been issued. This offers the opportunity for central review of radiation therapy plans before the start of treatment and the treating clinician a chance to modify plans.

  1. Results of a Quality Assurance Review of External Beam Radiation Therapy in the International Society of Paediatric Oncology (Europe) Neuroblastoma Group's High-risk Neuroblastoma Trial: A SIOPEN Study

    Energy Technology Data Exchange (ETDEWEB)

    Gaze, Mark N., E-mail: mark.gaze@uclh.nhs.uk [Department of Oncology, University College London Hospitals NHS Foundation Trust, London (United Kingdom); Boterberg, Tom [Department of Radiation Oncology, Ghent University Hospital, Ghent (Belgium); Dieckmann, Karin; Hoermann, Marcus [General Hospital Vienna, Medical University Vienna (Austria); Gains, Jennifer E.; Sullivan, Kevin P. [Department of Oncology, University College London Hospitals NHS Foundation Trust, London (United Kingdom); Ladenstein, Ruth [Children' s Cancer Research Institute, St. Anna Children' s Hospital, Vienna (Austria)

    2013-01-01

    Purpose: Radiation therapy is important for local control in neuroblastoma. This study reviewed the compliance of plans with the radiation therapy guidelines of the International Society of Paediatric Oncology (Europe) Neuroblastoma Group (SIOPEN) High-Risk Trial protocol. Methods and Materials: The SIOPEN trial central electronic database has sections to record diagnostic imaging and radiation therapy planning data. Individual centers may upload data remotely, but not all centers involved in the trial chose to use this system. A quality scoring system was devised based on how well the radiation therapy plan matched the protocol guidelines, to what extent deviations were justified, and whether adverse effects may result. Central review of radiation therapy planning was undertaken retrospectively in 100 patients for whom complete diagnostic and treatment sets were available. Data were reviewed and compared against protocol guidelines by an international team of radiation oncologists and radiologists. For each patient in the sample, the central review team assigned a quality assurance score. Results: It was found that in 48% of patients there was full compliance with protocol requirements. In 29%, there were deviations for justifiable reasons with no likely long-term adverse effects resulting. In 5%, deviations had occurred for justifiable reasons, but that might result in adverse effects. In 1%, there was a deviation with no discernible justification, which would not lead to long-term adverse events. In 17%, unjustified deviations were noted, with a risk of an adverse outcome resulting. Conclusions: Owing to concern over the proportion of patients in whom unjustified deviations were observed, a protocol amendment has been issued. This offers the opportunity for central review of radiation therapy plans before the start of treatment and the treating clinician a chance to modify plans.

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