The analysis of observational databases requires making choices during the design of an epidemiology evaluation study. Decisions need to be made about the design (e.g., cohort vs. case-control vs. self-controlled case series), the choice of comparator, the duration of follow-up during which events are “counted” as associated with a particular exposure, and the selection of covariates for adjustment among others. The Observational Medical Outcomes Partnership (OMOP) is attempting to capture these decisions across a large group of scientists to help inform better research and methods applications.

You are invited to participate in a research study, OMOP Epidemiology Design Decision Inventory and Evaluation (EDDIE), being conducted by OMOP to better understand these very decisions. Your participation in this study is entirely voluntary.

Download the EDDIE study overview for more information. Then to get started, go to the web-based survey - EDDIE. The Indiana University Institutional Review Board has reviewed this project, Protocol #: 1107006236; IRB-03, IRB00000228. The study will close January 31, 2012.

We refer to the choices that need to be made in observational studies as “parameters” reflecting configurable options that can be specified within the standardized implementation of methods within the OMOP experiment, for more details, go to the Methods Library. OMOP conducted a full factorial design evaluating a large set of parameter combinations, and measured the performance of each parameter combination on its ability to identify true drug safety issues and minimize false positive findings for different statistical methods. We want to capture what experts believe to be the most rational choices for these studies in order to identify those methods and parameters with the best performance.

The purpose of the study is to capture (using a web-based survey) and analyze the potential decisions that epidemiologists, statisticians, clinicians, and other researchers would make when designing a study to determine the association between drugs and potential outcomes of interest (for example, ACE inhibitors and Angioedema). We would like to understand what choices researchers would make, what variability in those choices may exist among researchers, what patterns emerge within design choices across drug-outcome pairs, and ultimately how those choices impact the ability to identify true effects, and not identify false findings.

Within the survey you will be asked a series of questions about how you would design an epidemiology evaluation study for specific drug-outcome pairs and specific decisions about how that design would be implemented. This is a web-based survey that you can complete within your own setting/location and you can pause at any time; the survey allows you to work straight through or save your answers and complete the survey over time. The time for completing one drug-outcome pair may take approximately ten to fifteen minutes. Therefore, if you choose to complete six drug-outcome pairs it is expected to take less than sixty minutes. If you decide to complete ALL the drug-outcome pairs available within the survey (thirty pairs in total), it may take you several hours. Completing additional drug-outcome pairs is entirely optional.

WHY SHOULD YOU PARTICIPATE IN THE SURVEY?

FUTURE OPPORTUNITIES! Asking how you would solve a problem might lead to solutions previously not considered.

MAKE A CONTRIBUTION. Your voice matters and this is a way to express your decisions and opinions and be a part of a real-time, ongoing scientific research project among scientists.

RESULTS. You will receive individualized reports that compare your responses to an anonymized composite summary of all respondents for the same drug-outcome pairs.

CHANCES TO WIN! There will be prize drawings at different levels depending on how many survey sections you complete. Respondents who complete all six pairs within a group will be entered into a drawing for an Amazon gift card worth one hundred dollars. After completing the first group of drug-outcome pairs, respondents will be invited to repeat the exercise for four other groups of six drug-outcome pairs. Respondents who complete all five groups (thirty drug-outcome pairs) will be entered into a drawing for an Amazon gift card worth one thousand dollars.

To find out more information and to get started, go to the web-based survey - EDDIE. The Indiana University Institutional Review Board has reviewed this project, Protocol #: 1107006236; IRB-03, IRB00000228. The study will close January 31, 2012.

Please share this information and link with your colleagues so they can also participate in the survey. If you have any questions, please contact contact OMOP.