How can observational trials inform and improve clinical practice

作者: Philip D. Home

DOI: 10.1016/S0168-8227(10)00192-0

关键词:

摘要: Randomized controlled trials (RCTs) are rightly considered to provide the highest quality, first-level information in evidence-based medicine, because their inherent design limits bias and confounding. However, a number of aspects conduct mean that they do not always accurately reflect actual clinical practice [1]: these include highly selected patient populations, treatment specialist centers, intensive supervision follow-up. Observational studies wide range study designs (cohort, case control, cross-sectional), common feature which is non-interventional, although participants often on basis having previously had specific intervention course routine practice. Such observational may prospective data ascertainment, used assess performance therapies post-licensing period. Here, ‘noninterventional’ means people only enrolled into once have been started particular therapy. Because randomized, susceptible confounding, and, while likely biases can be compensated for and/or statistical analysis, unknown factors also influence results [2]. Another limiting factor many lack control population. With reservations, from complement those RCTs by providing an insight how treatments perform dayto-day more clinically representative populations. cost resource advantages applicable larger diverse The first article this supplement will examine different types trials, differ RCTs, relevance provide. Additionally, roles healthcare professionals, health authorities, industry planning such examined [3].

参考文章(12)
Dele O Abegunde, Colin D Mathers, Taghreed Adam, Monica Ortegon, Kathleen Strong, None, The burden and costs of chronic diseases in low-income and middle-income countries The Lancet. ,vol. 370, pp. 1929- 1938 ,(2007) , 10.1016/S0140-6736(07)61696-1
Stuart L. Silverman, From Randomized Controlled Trials to Observational Studies The American Journal of Medicine. ,vol. 122, pp. 114- 120 ,(2009) , 10.1016/J.AMJMED.2008.09.030
A. Ringborg, C. Cropet, B. Jönsson, J. J. Gagliardino, A. Ramachandran, P. Lindgren, Resource use associated with type 2 diabetes in Asia, Latin America, the Middle East and Africa: results from the International Diabetes Management Practices Study (IDMPS) International Journal of Clinical Practice. ,vol. 63, pp. 997- 1007 ,(2009) , 10.1111/J.1742-1241.2009.02098.X
Nick Freemantle, Thomas Strack, Real-world effectiveness of new medicines should be evaluated by appropriately designed clinical trials. Journal of Clinical Epidemiology. ,vol. 63, pp. 1053- 1058 ,(2010) , 10.1016/J.JCLINEPI.2009.07.013
Siddharth N. Shah, León Litwak, Jihad Haddad, Praful N. Chakkarwar, Issam Hajjaji, The A1chieve study: a 60 000-person, global, prospective, observational study of basal, meal-time, and biphasic insulin analogs in daily clinical practice Diabetes Research and Clinical Practice. ,vol. 88, ,(2010) , 10.1016/S0168-8227(10)70003-6
SeiHyun Baik, Antônio Roberto Chacra, Li Yuxiu, Jeremy White, Serdar Güler, Zafar A. Latif, Conducting cost-effectiveness analyses of type 2 diabetes in low- and middle-income countries: can locally generated observational study data overcome methodological limitations? Diabetes Research and Clinical Practice. ,vol. 88, ,(2010) , 10.1016/S0168-8227(10)70004-8
N. Unwin, K. G. M. M. Alberti, Chronic non-communicable diseases Annals of Tropical Medicine and Parasitology. ,vol. 100, pp. 455- 464 ,(2006) , 10.1179/136485906X97453
Wenying Yang, Alexey Zilov, Pradana Soewondo, Ole Molskov Bech, Fawzia Sekkal, Philip D. Home, Observational studies: going beyond the boundaries of randomized controlled trials. Diabetes Research and Clinical Practice. ,vol. 88, ,(2010) , 10.1016/S0168-8227(10)70002-4
Joses M Kirigia, Hama B Sambo, Luis G Sambo, Saidou P Barry, None, Economic burden of diabetes mellitus in the WHO African region BMC International Health and Human Rights. ,vol. 9, pp. 6- 6 ,(2009) , 10.1186/1472-698X-9-6