Observational Studies in a Learning Health System Workshop Summary (2013) / Chapter Skim
Currently Skimming:
2 Issues Overview for Observational Studies in Clinical Research
2 Issues Overview for Observational Studies in Clinical Research
Pages 9-16
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 9... ...
Goodman, Associate Dean for Clinical and Translational Research at the Stanford University School of Medicine, highlighted some of the issues involved in the use of clinical data, whether it be from a randomized controlled trial (RCT) or an observational study, to draw conclusions that are relevant to the health care decisions made by physicians and their patients.
|
From page 10... ...
Goodman explained the resulting conundrum as such: the bottom-line advice for a specific patient depends on whether the patient wants to lose weight or control blood lipids, and that choice depends on multiple factors that were not included as variables in the study that generated the data. Goodman cited the conflicting findings for hormone replacement therapy between a large number of observational studies and the RCT conducted by the Women's Health Initiative.
|
From page 11... ...
As a result, no formulaic, algorithmic method is able to determine what types of studies are needed and in what temporal order studies should be conducted to answer a specific clinical question. Indeed, he explained, the decision to choose between an observational study and an RCT depends on multiple factors, including • the size and nature of the signal, • the size of the effect needed to justify a change in policy, • temporal urgency, • other potential causes of the outcome and whether the study will look for intended or unintended consequences, • the quality and the availability of data, • transportability, and • the analytical approach as well as the study design.
|
From page 12... ...
The framework also stresses that the study design must account for state-of-the-art research methodologies. Goodman cited his earlier example of the Women's Health FIGURE 2-1 Phase 2 of PCORI translational framework to guide design of new clinical comparative effectiveness studies for specific research questions.
|
From page 13... ...
His impression, based on his work on these two reports, is that there seems to be a strong need to apply the same, somewhat formulaic rules of evidence and design familiar to individuals in the world of evidence-based medicine to observational data. This need is apparent in the demand to create rules, or at least a social consensus, about what constitutes legitimate study designs for various questions.
|
From page 14... ...
DISCUSSION During the discussion that followed Goodman's presentation, a number of participants stated the importance for researchers to first ask the right questions needed to make a clinically meaningful decision and then choose the study design and methodological tools to best answer those questions. Too often, participants commented, decision makers do not know the question that a study is answering and researchers do not delimit the question that they are asking or put a study into context, making the decision maker's job more difficult than it should be.
|
From page 15... ...
Washington, DC: The National Academies Press. Patient-Centered Outcomes Research Institute Methodology Committee.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.