Observational studies often make clinical practice recommendations: an empirical evaluation of authors' attitudes

被引:56
作者
Prasad, Vinay [1 ]
Jorgenson, Joel [2 ]
Ioannidis, John P. A. [3 ,4 ]
Cifu, Adam [5 ]
机构
[1] NCI, Med Oncol Branch, NIH, Bethesda, MD 20892 USA
[2] Northwestern Univ, Feinberg Sch Med, Chicago, IL 60611 USA
[3] Stanford Univ, Dept Med, Sch Med, Stanford Prevent Res Ctr, Stanford, CA 94305 USA
[4] Stanford Univ, Sch Med, Dept Hlth Res & Policy, Stanford, CA 94305 USA
[5] Univ Chicago, Med Ctr, Dept Med, Pritzker Sch Med, Chicago, IL 60637 USA
关键词
Epidemiology; Clinical trials; Observational studies; Randomized trials; Hierarchy of research design; Reversal; CONTROLLED-TRIALS; MEDICAL REVERSAL; CANCER; EPIDEMIOLOGY; FALSE;
D O I
10.1016/j.jclinepi.2012.11.005
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Objectives: Although observational studies provide useful descriptive and correlative information, their role in the evaluation of medical interventions remains contentious. There has been no systematic evaluation of authors' attitudes toward their own nonrandomized studies and how often they recommend specific medical practices. Study Design and Setting: We reviewed all original articles of nonrandomized studies published in 2010 in New England Journal of Medicine, Lancet, Journal of the American Medical Association, and Annals of Internal Medicine, We classified articles based on whether authors recommend a medical practice and whether they state that a randomized trial is needed to support their recommendation. We also examined the types of logical extrapolations used by authors who did advance recommendations. Results: Of the 631 original articles published in 2010, 298 (47%) articles were eligible observational studies. In 167 (56%) of 298 studies, authors recommended a medical practice based on their results. Only 24 (14%) of 167 studies stated that a randomized controlled trial (RCT) should be done to validate the recommendation, whereas the other 143 articles made a total of 149 logical extrapolations to recommend specific medical practices. Recommendations without a call for a randomized trial were most common in studies of modifiable factors (59%), but they were also common in studies reporting incidence or prevalence (51%), studies examining novel tests (41%), and association studies of nonmodifiable factors (32%). Conclusion: The authors of observational studies often extrapolate their results to make recommendations concerning a medical practice, typically without first calling for a RCT. Published by Elsevier Inc.
引用
收藏
页码:361 / 366
页数:6
相关论文
共 33 条
[1]   A comparison of observational studies and randomized, controlled trials. [J].
Benson, K ;
Hartz, AJ .
NEW ENGLAND JOURNAL OF MEDICINE, 2000, 342 (25) :1878-1886
[2]   False-positive results in cancer epidemiology: A plea for epistemological modesty [J].
Boffetta, Paolo ;
McLaughlin, Joseph K. ;
La Vecchia, Carlo ;
Tarone, Robert E. ;
Lipworth, Loren ;
Blot, William J. .
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2008, 100 (14) :988-995
[3]   The Thin Line Between Hope and Hype in Biomarker Research [J].
Bossuyt, Patrick M. M. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2011, 305 (21) :2229-2230
[4]  
Choi Hyon K., 2010, JAMA (Journal of the American Medical Association), V304, P2270, DOI 10.1001/jama.2010.1638
[5]   Randomized, controlled trials, observational studies, and the hierarchy of research designs. [J].
Concato, J ;
Shah, N ;
Horwitz, RI .
NEW ENGLAND JOURNAL OF MEDICINE, 2000, 342 (25) :1887-1892
[6]   Electronic Health Record Technology [J].
Cresswell, Kathrin ;
Sheikh, Aziz .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2012, 307 (21) :2255-2256
[7]   Adult and child malaria mortality in India: a nationally representative mortality survey [J].
Dhingra, Neeraj ;
Jha, Prabhat ;
Sharma, Vinod P. ;
Cohen, Alan A. ;
Jotkar, Raju M. ;
Rodriguez, Peter S. ;
Bassani, Diego G. ;
Suraweera, Wilson ;
Laxminarayan, Ramanan ;
Peto, Richard .
LANCET, 2010, 376 (9754) :1768-1774
[8]   Childhood Obesity, Other Cardiovascular Risk Factors, and Premature Death [J].
Franks, Paul W. ;
Hanson, Robert L. ;
Knowler, William C. ;
Sievers, Maurice L. ;
Bennett, Peter H. ;
Looker, Helen C. .
NEW ENGLAND JOURNAL OF MEDICINE, 2010, 362 (06) :485-493
[9]   Change in Disability After Hospitalization or Restricted Activity in Older Persons [J].
Gill, Thomas M. ;
Allore, Heather G. ;
Gahbauer, Evelyne A. ;
Murphy, Terrence E. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2010, 304 (17) :1919-1928
[10]   Bias in clinical intervention research [J].
Gluud, LL .
AMERICAN JOURNAL OF EPIDEMIOLOGY, 2006, 163 (06) :493-501