Observational Studies Can Inform Health Decisions—When Done Correctly. TO IMPROVEHEALTH CAREQUALITY & REDUCE HEALTH CARECOSTSTHERE IS A GROWING DEMAND FOR AND SUPPLY OF OBSERVATIONAL STUDIES*
*Sometimes called real-word evidence orevidence from clinical experience.
OBSERVATIONAL STUDIES HAVE SEVERAL STRENGTHS
Provide information about diverse populations.
Improve understanding of patient-centered outcomes.
Tell us how treatments work in real-world settings.
Can be conducted more quickly for timely results.
BUT ALSO HAVE LIMITATIONS THAT NEED TO BE ACCOUNTED FOR
Many factors drive treatment decisions
Real-world patients can have complex clinical conditions.
Some studies must address unbalanced groups, differential follow-up and missing data.
WHAT MAKES OBSERVATIONAL STUDIES HIGH QUALITY?
New research gives us an idea.
9 standards and guidelines for observational studies
23 items that observational studies should include
WHAT DID THEY FIND?
2 items are addressed and have agreement across standards and guidelines
Defining study objectives and research questions
Including details on data sources
12 items are addressed but disagree across standards and guidelines, such as
Describing study limitations
Handling missing data
9 items are addressed by some but not all standards and guidelines, such as
Reviewing prior research
Involving stakeholders in research
Assessing heterogeneity of treatment effects
LACK OF COMMON STANDARDS FOR HIGH-QUALITY OBSERVATIONAL STUDIES CAN IMPACT
What Studies FUNDERS Support
What Methods RESEARCHERS Apply
What StudiesJOURNAL EDITORS Publish
What Evidence PATIENTS, PROVIDERSand PAYERS Use
HOW DO WE AGREE ON WHAT “GOOD” LOOKS LIKE?
AUTHORS RECOMMEND 4 STEPS
GAIN ALIGNMENT: Perspectives may differ, but what
items are included should not
AGREE ON LEVEL OF CONSENSUS: Minimum standards rather than best practices are most achievable
GARNER CONSENSUS: Stakeholders should convene in an iterative process to gain consensus
ENCOURAGE CONSENSUS: Voluntary adoption is most likely for success
Source: Morton SC, Costlow MR, Graff JS, Dubois RW. Standards and Guidelines for Observational Studies: Quality Is in the Eye of the Beholder. The Journal of Clinical Epidemiology. 2015. Online ahead of print: November 5, 2015.