Observational studies follow patients overtime and can evaluate the effect of interventions on health outcomes
Strengths of Observational Studies
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
There is a growing demand for comparative effectiveness research (CER) and how interventions work in the real world. Yet there is debate whether and when observational studies are good enough to support decision-making.
Limitations of Observational Studies
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.
A helpful tool
When done correctly, observational studies can provide meaningful information; when done poorly, misinterpretations are possible. The Good Research for Comparative Effectiveness (GRACE) Checklist was developed as a guide to assess the quality of observational studies and to help ensure that the information used is credible and reliable.
treatment details adequately recorded?
Primary outcomes adequately recorded?
Primary clinical outcomes measured objectively>
Primary outcomes valid?
primary outcome measured or identified equally between treatment and comparison groups
Differences between study groups captured?
Study population restricted to new users of medications?
Comparative data collected for same time period?
Differences between study groups taken into account
Outcomes of interest captured for all treatment groups?
Sensitivity of conclusion to key assumptions analyzed?
The is an abridged version of questions in the GRACE checklist. For more information, check out the March 2014 Journal of Managed Care Pharmacy
Source: Dryer NA, Velentgas P. Westrich K Dubois RW. The GRACE Checklist for Rating the Quality of Observational Studies of Comparative Effectiveness: A Tale of Hope and Caution J Manag Care pharm. 2014.20(3):1-12