Viewpoint |

The Value of Statistical Analysis Plans in Observational Research:  Defining High-Quality Research From the Start

Laine Thomas, PhD; Eric D. Peterson, MD, MPH
JAMA. 2012;308(8):773-774. doi:10.1001/jama.2012.9502.
Text Size: A A A
Published online


The increasing availability of electronic health data combined with federal investment has stimulated an expansion in observational clinical research.1 Observational studies can complement clinical trials and provide important information about comparative safety and effectiveness in populations not well studied in clinical trials. However, there are numerous examples in which the findings from observational studies have failed to be replicated.2 These failures may be due to several factors, including the exploratory nature of observational questions, failure to fully account for treatment selection bias, known publication biases, and the tendency to pursue post hoc hypotheses. This later problem, termed data dredging, is facilitated by the lack of fidelity to a prespecified hypothesis and inadequate reporting of the actual analytic process.

Sign In to Access Full Content

Don't have Access?

Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more

Subscribe for full-text access to content from 1998 forward and a host of useful features

Activate your current subscription (AMA members and current subscribers)

Purchase Online Access to this article for 24 hours

First Page Preview

View Large
First page PDF preview




January 2, 2013
Quoc-Dien Trinh, MD; Maxine Sun, BSc
JAMA. 2013;309(1):32. doi:10.1001/jama.2012.56907.
January 2, 2013
Laine Thomas, PhD; Eric D. Peterson, MD, MPH
JAMA. 2013;309(1):32. doi:10.1001/jama.2012.56917.
Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).


Some tools below are only available to our subscribers or users with an online account.

Web of Science® Times Cited: 12

Sign In to Access Full Content

Related Content

Customize your page view by dragging & repositioning the boxes below.

See Also...
Articles Related By Topic
Related Topics