5 results
Review of real-world evidence studies in type 2 diabetes mellitus: Lack of good practices
- Véronique Lambert-Obry, Jean-Philippe Lafrance, Michelle Savoie, Sandrine Henri, Jean Lachaine
-
- Journal:
- International Journal of Technology Assessment in Health Care / Volume 36 / Issue 4 / August 2020
- Published online by Cambridge University Press:
- 24 June 2020, pp. 372-379
-
- Article
- Export citation
-
Objectives
Unlike randomized controlled trials, lack of methodological rigor is a concern about real-world evidence (RWE) studies. The objective of this study was to characterize methodological practices of studies collecting pharmacoeconomic data in a real-world setting for the management of type 2 diabetes mellitus (T2DM).
MethodsA systematic literature review was performed using the PICO framework: population consisted of T2DM patients, interventions and comparators were any intervention for T2DM care or absence of intervention, and outcomes were resource utilization, productivity loss or utility. Only RWE studies were included, defined as studies that were not clinical trials and that collected de novo data (no retrospective analysis).
ResultsThe literature search identified 1,158 potentially relevant studies, among which sixty were included in the literature review. Many studies showed a lack of transparency by not mentioning the source for outcome and exposure measurement, source for patient selection, number of study sites, recruitment duration, sample size calculation, sampling method, missing data, approbation by an ethics committee, obtaining patient's consent, conflicts of interest, and funding. A significant proportion of studies had poor quality scores and was at high risk of bias.
ConclusionsRWE from T2DM studies lacks transparency and credibility. There is a need for good procedural practices that can increase confidence in RWE studies. Standardized methodologies specifically adapted for RWE studies collecting pharmacoeconomic data for the management of T2DM could help future reimbursement decision making in this major public health problem.
Contributors
-
- By Jane E. Adcock, Yahya Aghakhani, A. Anand, Eva Andermann, Frederick Andermann, Alexis Arzimanoglou, Sandrine Aubert, Nadia Bahi-Buisson, Carman Barba, Agatino Battaglia, Geneviève Bernard, Nadir E. Bharucha, Laurence A. Bindoff, William Bingaman, Francesca Bisulli, Thomas P. Bleck, Stewart G. Boyd, Andreas Brunklaus, Harry Bulstrode, Jorge G. Burneo, Laura Canafoglia, Laura Cantonetti, Roberto H. Caraballo, Fernando Cendes, Kevin E. Chapman, Patrick Chauvel, Richard F. M. Chin, H. T. Chong, Fahmida A. Chowdhury, Catherine J. Chu-Shore, Rolando Cimaz, Andrew J. Cole, Bernard Dan, Geoffrey Dean, Alessio De Ciantis, Fernando De Paolis, Rolando F. Del Maestro, Irissa M. Devine, Carlo Di Bonaventura, Concezio Di Rocco, Henry B. Dinsdale, Maria Alice Donati, François Dubeau, Michael Duchowny, Olivier Dulac, Monika Eisermann, Brent Elliott, Bernt A. Engelsen, Kevin Farrell, Natalio Fejerman, Rosalie E. Ferner, Silvana Franceschetti, Robert Friedlander, Antonio Gambardella, Hector H. Garcia, Serena Gasperini, Lorenzo Genitori, Gioia Gioi, Flavio Giordano, Leif Gjerstad, Daniel G. Glaze, Howard P. Goodkin, Sidney M. Gospe, Andrea Grassi, William P. Gray, Renzo Guerrini, Marie-Christine Guiot, William Harkness, Andrew G. Herzog, Linda Huh, Margaret J. Jackson, Thomas S. Jacques, Anna C. Jansen, Sigmund Jenssen, Michael R. Johnson, Dorothy Jones-Davis, Reetta Kälviäinen, Peter W. Kaplan, John F. Kerrigan, Autumn Marie Klein, Matthias Koepp, Edwin H. Kolodny, Kandan Kulandaivel, Ruben I. Kuzniecky, Ahmed Lary, Yolanda Lau, Anna-Elina Lehesjoki, Maria K. Lehtinen, Holger Lerche, Michael P. T. Lunn, Snezana Maljevic, Mark R. Manford, Carla Marini, Bindu Menon, Giulia Milioli, Eli M. Mizrahi, Manish Modi, Márcia Elisabete Morita, Manuel Murie-Fernandez, Vivek Nambiar, Lina Nashef, Vincent Navarro, Aidan Neligan, Ruth E. Nemire, Charles R. J. C. Newton, John O'Donavan, Hirokazu Oguni, Teiichi Onuma, Andre Palmini, Eleni Panagiotakaki, Pasquale Parisi, Elena Parrini, Liborio Parrino, Ignacio Pascual-Castroviejo, M. Scott Perry, Perrine Plouin, Charles E. Polkey, Suresh S. Pujar, Karthik Rajasekaran, R. Eugene Ramsey, Rahul Rathakrishnan, Roberta H. Raven, Guy M. Rémillard, David Rosenblatt, M. Elizabeth Ross, Abdulrahman Sabbagh, P. Satishchandra, Swati Sathe, Ingrid E. Scheffer, Philip A. Schwartzkroin, Rod C. Scott, Frédéric Sedel, Michelle J. Shapiro, Elliott H. Sherr, Michael Shevell, Simon D. Shorvon, Adrian M. Siegel, Gagandeep Singh, S. Sinha, Barbara Spacca, Waney Squier, Carl E. Stafstrom, Bernhard J. Steinhoff, Andrea Taddio, Gianpiero Tamburrini, C. T. Tan, Raymond Y. L. Tan, Erik Taubøll, Robert W. Teasell, Mario Giovanni Terzano, Federica Teutonico, Suzanne A. Tharin, Elizabeth A. Thiele, Pierre Thomas, Paolo Tinuper, Dorothée Kasteleijn-Nolst Trenité, Sumeet Vadera, Pierangelo Veggiotti, Jean-Pierre Vignal, J. M. Walshe, Elizabeth J. Waterhouse, David Watkins, Ruth E. Williams, Yue-Hua Zhang, Benjamin Zifkin, Sameer M. Zuberi
- Edited by Simon D. Shorvon, Frederick Andermann, Renzo Guerrini
-
- Book:
- The Causes of Epilepsy
- Published online:
- 05 March 2012
- Print publication:
- 14 April 2011, pp ix-xvi
-
- Chapter
- Export citation
Relationships between different types of fruit and vegetable consumption and serum concentrations of antioxidant vitamins
- Luc Dauchet, Sandrine Péneau, Sandrine Bertrais, Anne Claire Vergnaud, Carla Estaquio, Emmanuelle Kesse-Guyot, Sébastien Czernichow, Alain Favier, Henri Faure, Pilar Galan, Serge Hercberg
-
- Journal:
- British Journal of Nutrition / Volume 100 / Issue 3 / September 2008
- Published online by Cambridge University Press:
- 18 February 2008, pp. 633-641
- Print publication:
- September 2008
-
- Article
-
- You have access Access
- HTML
- Export citation
-
Increased fruit and vegetable consumption has become a health priority in many countries. Therefore, data investigating the influence of different types of fruits and vegetables on serum antioxidant levels would be useful. The objective of the study was to assess the relationship between fruit and vegetable consumption and vitamin serum antioxidant concentrations. Specific fruit and vegetable groups are evaluated. A total of 3521 subjects (1487 men and 2034 women), aged 35–60 years, participating in the SU.VI.MAX cohort were included in this study. Blood samples of participants were analysed for β-carotene, vitamin C and α-tocopherol. Each subject had completed at least six dietary records during the first 2 years of the study. It was found that women had higher mean β-carotene and vitamin C serum concentrations than men, but lower α-tocopherol serum concentrations. Serum β-carotene and vitamin C concentrations were positively correlated with consumption of both fruit and vegetables, as well as with most of the fruit and vegetable groups tested. These relationships persisted after adjustment for confounding factors. Regression analysis showed a linear dose–response relationship. Root vegetables and citrus fruits were particularly associated with β-carotene serum status as were citrus fruits for vitamin C. Fruit and vegetable consumption was either not or weakly associated with α-tocopherol serum concentrations. These results describe antioxidant serum concentrations according to fruit and vegetable consumption in a large sample and support the findings of previous studies involving a more limited number of subjects.
Antioxidant status and risk of cancer in the SU.VI.MAX study: is the effect of supplementation dependent on baseline levels?
- Pilar Galan, Serge Briançon, Alain Favier, Sandrine Bertrais, Paul Preziosi, Henri Faure, Josiane Arnaud, Nathalie Arnault, Sébastien Czernichow, Louise Mennen, Serge Hercberg
-
- Journal:
- British Journal of Nutrition / Volume 94 / Issue 1 / July 2005
- Published online by Cambridge University Press:
- 08 March 2007, pp. 125-132
- Print publication:
- July 2005
-
- Article
-
- You have access Access
- Export citation
-
The SUpplementation en VItamines et Mineraux AntioXydants (SU.VI.MAX) study, a randomised double-blind, primary-prevention trial showed that after 7·5 years, low-dose antioxidant supplementation lowered the total cancer incidence in men, but not in women. To explain this difference in the impact of antioxidant supplementation in men and women, we hypothesised that the effect of supplementation is dependent on initial antioxidant status; 12 741 French adults (7713 females aged 35–60 years; 5028 males aged 45–60 years) received daily antioxidant supplementation (120 mg vitamin C, 30 mg vitamin E, 6 mg β-carotene, 100 μg Se, 20 mg Zn daily) or a matching placebo. Cut-off limits for baseline serum concentrations of the different antioxidant vitamins and minerals were defined as follows for both men and women: 0·3 μmol/l for β-carotene, 11·4 μmol/l for vitamin C, 15 μmol/l for vitamin E, 0·75 μmol/l for Se and 10·7 μmol/l for Zn. The percentage of men with serum concentrations under cut-off limits was higher for vitamins C and E and β-carotene in those who developed a cancer than in those who did not. The risk of cancer was higher in men with baseline concentrations of serum vitamin C or vitamin E under cut-off limits, but not in women. The effect of supplementation was greater in men with baseline serum concentrations of vitamin C, vitamin E and β-carotene below the cut-off limits compared with those above it. This effect was maintained only for vitamin E after adjustment for age, tobacco, and alcohol consumption and BMI. No effect of supplementation could be seen in women. Baseline antioxidant status is related to the risk of cancer in men but not in women and therefore does not entirely explain the differences observed in the effect of antioxidant supplementation on cancer risk between sexes in the SU.VI.MAX study.
12 - Genetics of human susceptibility to infection and hepatic disease caused by schistosomes
-
- By Alain J. Dessein, Immunologie et Génétique des Maladies Parasitaires, Institut National de la Santé et de la Recherche Médicale, Laboratoire de Parasitologie-Mycologie, Faculté de Médecine, Marseille, France, Sandrine Marquet, Immunologie et Génétique des Maladies Parasitaires, Institut National de la Santé et de la Recherche Médicale, Laboratoire de Parasitologie-Mycologie, Faculté de Médecine, Marseille, France, Carole Eboumbou Moukoko, Immunologie et Génétique des Maladies Parasitaires, Institut National de la Santé et de la Recherche Médicale, Laboratoire de Parasitologie-Mycologie, Faculté de Médecine, Marseille, France, Hèlia Dessein, Immunologie et Génétique des Maladies Parasitaires, Institut National de la Santé et de la Recherche Médicale, Laboratoire de Parasitologie-Mycologie, Faculté de Médecine, Marseille, France, Laurent Argiro, Immunologie et Génétique des Maladies Parasitaires, Institut National de la Santé et de la Recherche Médicale, Laboratoire de Parasitologie-Mycologie, Faculté de Médecine, Marseille, France, Sandrine Henri, Immunologie et Génétique des Maladies Parasitaires, Institut National de la Santé et de la Recherche Médicale, Laboratoire de Parasitologie-Mycologie, Faculté de Médecine, Marseille, France, Dominique Hillaire, Immunologie et Génétique des Maladies Parasitaires, Institut National de la Santé et de la Recherche Médicale, Laboratoire de Parasitologie-Mycologie, Faculté de Médecine, Marseille, France, Christophe Chevillard, Immunologie et Génétique des Maladies Parasitaires, Institut National de la Santé et de la Recherche Médicale, Laboratoire de Parasitologie-Mycologie, Faculté de Médecine, Marseille, France, Nasureldin El Wali, Institute of Nuclear Medicine and Molecular Biology, University of Gezira, Wad Medani, Sudan, Mubarak Magzoub, Institute of Nuclear Medicine and Molecular Biology, University of Gezira, Wad Medani, Sudan, Laurent Abel, Génétique Humaine des Maladies Infectieuses, Institut National de la Santé et de la Recherche Médicale, Faculté de Médecine Necker, Paris, Virmondes Rodrigues, Jr, Faculty of Medicine do Triangulo Mineiro, Ubéraba, Brazil, Aluizio Prata, Faculty of Medicine do Triangulo Mineiro, Ubéraba, Brazil, Gachuhi Kimani, Kenya Medical Research Institute, Biomedical Sciences Research Centre, Nairobi, Kenya
- Edited by Richard Bellamy, Kintampo Health Research Centre, Ghana
-
- Book:
- Susceptibility to Infectious Diseases
- Published online:
- 14 August 2009
- Print publication:
- 22 December 2003, pp 337-360
-
- Chapter
- Export citation
-
Summary
Schistosome infections cause much suffering in millions of people living in tropical regions of Africa, Asia, and South America (Prata, 1987; Chitsulo et al., 2000). The most severe clinical symptoms affect the kidneys and urinary tract. However, schistosomes also cause various other disorders such as heart failure and neurological diseases. Three species of schistosome are responsible for most human infections (Schistosoma mansoni, Schistosoma japonicum, and Schistosoma haematobium). These species are found in different geographical locations, have different vectors, and cause different symptoms. Schistosomes are multicellular parasites that are disseminated as free swimming larvae (cercariae) in ponds, lakes, and rivers by snails. Humans become infected when they stay in contaminated water for a few minutes. The cercariae penetrate the human skin and develop into male or female adult schistosomes within 5 or 6 weeks. These small worms (Fig. 12.1A) can live in the vascular system of their vertebrate host for 2 to 5 years. Schistosomes do not multiply within their vertebrate host. The female worms, however, lay hundreds of eggs per day in the mesenteric or vesical veins of their host. Most of the symptoms associated with these infections are caused by the inflammation that is induced by the immunogenic and toxic substances produced by the eggs. The chronic cellular reaction that develops around the eggs is organised in a granuloma (Von Lichtenberg, 1962; Warren et al., 1967).