Protocol - Diabetic Retinopathy
The protocol includes three interviewer-administered questions from the Los Angeles Latino Eye Study (LALES) that capture whether a respondent has eye disease due to diabetes and whether the respondent has had laser treatment for retinopathy.
These questions about diabetic retinopathy from the Los Angeles Latino Eye Study (LALES) are also included in the Personal and Family History of Eye Disease and Treatments measure. Therefore, selecting these two protocols together will result in selecting the same questions multiple times.
The Expert Review Panel recommends that an additional question be added to this protocol to determine if the individual had eye treatment with anti-vascular endothelial growth factor (VEGF) agents. The revised protocol is available here: Revised Protocol for Diabetic Retinopathy
1. Has a medical doctor ever told you that diabetes has affected blood vessels in your eyes or that you had diabetic retinopathy or diabetic eye disease?
1 [ ] yes
2 [ ] no (skip to end)
8 [ ] refused (skip to end)
9 [ ] DK (skip to end)
2. Did you ever have laser treatment or surgery for your diabetic eye disease?
1 [ ] yes, laser treatment
2 [ ] yes, surgery
3 [ ] yes, both
4 [ ] no (skip to end)
8 [ ] refused (skip to end)
9 [ ] DK (skip to end)
2a. How many different times have you had laser treatment or surgery for diabetic eye disease?
98 [ ] refused
99 [ ] DK
Protocol Name from Source:
Los Angeles Latino Eye Study (LALES) Section D: Ocular Disease History
Personnel and Training Required
The interviewer must be trained to conduct personal interviews with individuals from the general population. The interviewer must be trained and found to be competent (i.e., tested by an expert) at the completion of personal interviews. The interviewer should be trained to prompt respondents further if a "don’t know" response is provided.
These questions can be administered in a computerized or non-computerized format (i.e., paper-and-pencil instrument). Computer software is necessary to develop computer-assisted instruments. The interviewer will require a laptop computer/handheld computer to administer a computer-assisted questionnaire.
|Specialized requirements for biospecimen collection||No|
|Average time of greater than 15 minutes in an unaffected individual||No|
Mode of Administration
Although the original study by was performed on adults aged 40 years old and older, the Diabetes Working Group recommends that these questions can be used for all adults.
The Los Angeles Latino Eye Study (LALES) was vetted against several other similar protocols and was chosen because it specifically asks the respondent whether diabetes has caused eye disease and the history of laser surgery in both eyes. Treatment with anti-vascular endothelial growth factor (VEGF) agents is becoming increasingly more used. Questions regarding it have not yet been incorporated into standard collection instruments such as that from LALES, although plans are in place for doing so. Consequently, question 3 has been added (see Specific Instructions) to cover this important treatment avenue.
|Common Data Elements (CDE)||Person Diabetic Retinopathy Assessment Description Text||3070684||CDE Browser|
|Logical Observation Identifiers Names and Codes (LOINC)||Diabetic retinopathy proto||62801-6||LOINC|
Process and Review
The Expert Review Panel #1 reviewed the measures in the Anthropometrics, Diabetes, Physical Activity and Physical Fitness, and Nutrition and Dietary Supplements domains.
Guidance from the ERP includes:
- No significant changes
Back-compatible: no changes to Data Dictionary
Previous version in Toolkit archive (link)
University of Southern California (UCLA). (2000-03). Los Angeles Latino Eye Study (LALES). Section D: Ocular Disease History. Questions 21, 22, and 22a.
American Diabetes Association (ADA). (2014). Standards of medical care in diabetes-2014. Diabetes Care, 37(Suppl. 1), S14-S80.
|Variable Name||Variable ID||Variable Description||Version||dbGaP Mapping|
|PX140701_Doctor_Retinopathy||PX140701010000||Has a medical doctor ever told you that diabetes has affected blood vessels in your eyes or that you had diabetic retinopathy or diabetic eye disease?||N/A|
|PX140701_Laser_Treatment||PX140701020000||Did you ever have laser treatment or surgery for your diabetic eye disease?||Variable Mapping|
|PX140701_Laser_Treatment_Times||PX140701020100||How many different times have you had laser treatment or surgery for diabetic eye disease?||Variable Mapping|
|PX140701_Laser_Treatment_Times_Coded||PX140701020101||How many different times have you had laser treatment or surgery for diabetic eye disease?||Variable Mapping|
October 1, 2015
A questionnaire to determine if a respondent has a history of retinopathy.
Diabetic retinopathy, which is the leading cause of blindness in adults, is associated with both type 1 and type 2 diabetes, and the incidence increases with the duration of the disease (ADA, 2009).
Diabetes, eye, eye disease, LALES,