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Protocol - Diabetic Retinopathy

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Protocol Name from Source:

Los Angeles Latino Eye Study (LALES) Section D: Ocular Disease History

Availability:

Publicly available

Description:

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.

Protocol:

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?

___# times

98 [ ] refused

99 [ ] DK

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.

Equipment Needs

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.

Requirements

Requirement CategoryRequired
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingNo

Mode of Administration

Self-administered

Life Stage:

Adult, Senior

Specific Instructions:

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: [link[www.phenxtoolkit.org/toolkit_content/supplemental_info/diabetes/additional_info/Revised%20Protocol%20for%20Diabetic%20Retinopathy_12-2-14version.docx|Revised Protocol for Diabetic Retinopathy]]

Research Domain Information

Release Date:

October 1, 2015

Definition

A questionnaire to determine if a respondent has a history of retinopathy.

Purpose

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).

Selection Rationale

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.

Language

English, Spanish

Standards

StandardNameIDSource
Common Data Elements (CDE)Person Diabetic Retinopathy Assessment Description Text3070684CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)Diabetic retinopathy proto62801-6LOINC

Process and Review

The [link[phenx.org/node/62|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[www.phenxtoolkit.org/index.php?pageLink=browse.archive.protocols&id=140000|link]])

Source

University of Southern California (UCLA). (2000-03). Los Angeles Latino Eye Study (LALES). Section D: Ocular Disease History. Questions 21, 22, and 22a.

General References

American Diabetes Association (ADA). (2014). Standards of medical care in diabetes-2014. Diabetes Care, 37(Suppl. 1), S14-S80.

Protocol ID:

140701

Variables:

Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX140701_Doctor_RetinopathyPX140701010000Has 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?4N/A
PX140701_Laser_TreatmentPX140701020000Did you ever have laser treatment or surgery for your diabetic eye disease?4Variable Mapping
PX140701_Laser_Treatment_TimesPX140701020100How many different times have you had laser treatment or surgery for diabetic eye disease?4N/A
PX140701_Laser_Treatment_Times_CodedPX140701020101How many different times have you had laser treatment or surgery for diabetic eye disease?4N/A