Traditional and Innovative Study Designs in Comparative Effectiveness Research

Author(s):  
J. Jaime Caro ◽  
Jack Ishak
2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Claudia M. Witt ◽  
Margaret Chesney ◽  
Richard Gliklich ◽  
Lawrence Green ◽  
George Lewith ◽  
...  

The increasing burden of chronic diseases presents not only challenges to the knowledge and expertise of the professional medical community, but also highlights the need to improve the quality and relevance of clinical research in this domain. Many patients now turn to complementary and integrative medicine (CIM) to treat their chronic illnesses; however, there is very little evidence to guide their decision-making in usual care. The following research recommendations were derived from a CIM Stakeholder Symposium on Comparative Effectiveness Research (CER): (1) CER studies should be made a priority in this field; (2) stakeholders should be engaged at every stage of the research; (3) CER study designs should highlight effectiveness over efficacy; (4) research questions should be well defined to enable the selection of an appropriate CER study design; (5) the CIM community should cultivate widely shared understandings, discourse, tools, and technologies to support the use and validity of CER methods; (6) Effectiveness Guidance Documents on methodological standards should be developed to shape future CER studies. CER is an emerging field and its development and impact must be reflected in future research strategies within CIM. This stakeholder symposium was a first step in providing systematic guidance for future CER in this field.


2012 ◽  
Vol 30 (34) ◽  
pp. 4202-4207 ◽  
Author(s):  
Melissa C. Brouwers ◽  
Lehana Thabane ◽  
David Moher ◽  
Sharon E. Straus

PurposeThe objectives of this article are (1) to examine the similarities and differences between comparative effectiveness research (CER) and evidence-based medicine (EBM); (2) to describe the implications of CER for systematic review methodologies in oncology; and (3) to address the transition from systematic reviews to guideline development and the implications of CER in this process.MethodAn analysis of the principles and methods of CER was undertaken in light of EBM, systematic reviews, and guidelines.Results and ConclusionThere is considerable overlap between the principles and methods of the two paradigms. The focus on best care options in the context of routine practice is a more central tenet of the CER paradigm. Thus, its value is not that it is the first paradigm to recognize the importance of a patient-focused approach in the research community, but rather, given the attention it has garnered, the CER paradigm may be precisely the reminder and push required to: one, influence how systematic questions are framed so that a more patient-relevant perspective is achieved; two, broaden the types of study designs that are valued and to include those, such as pragmatic trials and observational studies, that are better able to answer effectiveness questions; three, accelerate the development and application of statistical methods that enable indirect comparisons of cancer care options; and four, create clinical practice guidelines that are better positioned to improve quality of care and system performance. Over time, we will see if the CER paradigm lives up to its potential.


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