Document Detail

"Lies, damned lies ..." and observational studies in comparative effectiveness research.
MedLine Citation:
PMID:  23725614     Owner:  NLM     Status:  MEDLINE    
A new federal initiative has allocated $1.1 billion to comparative effectiveness research, and many have emphasized the importance of including observational studies in this effort. The rationale for using observational studies to assess comparative effectiveness is based on concerns that randomized controlled trials (RCTs) are not "real world" because they enroll homogeneous patient populations, measure study outcomes that are not important to patients, use protocols that are overly complex, are conducted in specialized centers, and use study treatments that are not consistent with usual care, and that RCTs are not always feasible because of a lack of equipoise, the need to assess delayed endpoints, and concerns that they take years to complete and are expensive. This essay questions the validity of each of these proposed limitations, summarizes concerns raised about the accuracy of results generated by observational studies, provides some examples of discrepancies between results of observational studies and RCTs that pertain to pulmonary and critical care, and suggests that using observational studies for comparative effectiveness research may increase rather than decrease the cost of health care and may harm patients.
Richard K Albert
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  American journal of respiratory and critical care medicine     Volume:  187     ISSN:  1535-4970     ISO Abbreviation:  Am. J. Respir. Crit. Care Med.     Publication Date:  2013 Jun 
Date Detail:
Created Date:  2013-06-03     Completed Date:  2013-07-30     Revised Date:  2014-01-15    
Medline Journal Info:
Nlm Unique ID:  9421642     Medline TA:  Am J Respir Crit Care Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1173-7     Citation Subset:  AIM; IM    
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MeSH Terms
Comparative Effectiveness Research / methods*
Decision Making*
Observation / methods*
Research Design*
Comment In:
Am J Respir Crit Care Med. 2013 Dec 1;188(11):1369-70   [PMID:  24289779 ]
Am J Respir Crit Care Med. 2013 Dec 1;188(11):1368-9   [PMID:  24289777 ]

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