ID
45282
Descrição
https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000001.v3.p1 The Age-Related Eye Disease Study (AREDS) was initially designed as a long-term multi-center, prospective study of the clinical course of age-related macular degeneration (AMD) and age-related cataract. In addition to collecting natural history data, AREDS included a clinical trial of high-dose vitamin and mineral supplements for AMD and a clinical trial of high-dose vitamin supplements for cataract. AREDS participants were 55 to 80 years of age at enrollment and had to be free of any illness or condition that would make long-term follow-up or compliance with study medications unlikely or difficult. On the basis of fundus photographs graded by a central reading center, best-corrected visual acuity and ophthalmologic evaluations, 4,757 participants were enrolled in one of several AMD categories, including persons with no AMD. The clinical trials for AMD and cataract were conducted concurrently. AREDS participants were followed on the clinical trials for a median time of 6.5 years. Subsequent to the conclusion of the clinical trials, participants were followed for an additional 5 years and natural history data were collected. The AREDS research design is detailed in AREDS Report 1. AREDS Report 8 contains the mainline results from the AMD trial; AREDS Report 9 contains the results of the cataract trial. Blood samples were also collected from 3,700+ AREDS participants for genetic research. Genetic samples from 600 AREDS participants (200 controls, 200 Neovascular AMD cases, and 200 Geographic Atrophy cases) were selected using data available in March 2005 and then were evaluated with a genome-wide scan. These data, as well as selected phenotypic data, were made available in the dbGaP. DNA from AREDS participants, which is currently being stored in the AREDS Genetic Repository, is available for research purposes. However, not all of the 3,700+ AREDS participants who submitted a blood sample currently have DNA available. In addition to including the data from the genome-wide scan on the 600 original samples, this second version of the AREDS dbGaP database provides a comprehensive set of data tables with extensive clinical information collected for the 4,757 participants who participated in AREDS. The tables include information collected at enrollment/baseline, during study follow-up, fundus and lens pathology, nutritional estimates, quality of life measures and measures of morbidity and mortality. In November 2010, over 72,000 high quality fundus and lens photographs from 595 AREDS participants (of the original 600 selected for the genome-wide scan) were made available in the AREDS dbGaP. In addition to the genome-wide scan data, the fundus and lens grading data for these participants are also available in the AREDS dbGaP. Details about the ocular photographs that are available are found here. In January 2012, a measure of daily sunlight exposure was added in a separate "sunlight" table. Furthermore, the "followup" table has been revised. The visual acuity for the right eye was inadvertently missing at odd-numbered visits (01, 03, 05, etc.). This data is now part of the table. It is hoped that this resource will better help researchers understand two important diseases that affect an aging population. These data may be applied to examination and inference on genetic and genetic-environmental bases for age-related diseases of public health significance and may also help elucidate the clinical course of both conditions, generate hypotheses, and aid in the design of clinical trials of preventive interventions. *Definitions of Final AMD Phenotype Categories* Please see phd001138.1 for a detailed description of how AREDS participants' final AMD phenotype was categorized. *User's Guide for AREDS Phenotype Data* A detailed User's Guide for the AREDS phenotype data is available. This *User's Guide* is meant to be a comprehensive document which explains the complexities of the AREDS data. *It is recommended that all researchers using AREDS phenotype data make use of this User's Guide*.
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Versões (2)
- 11/05/2022 11/05/2022 - Martin Dugas
- 12/10/2022 12/10/2022 - Adrian Schulz
Titular dos direitos
Susan B. Bressler, MD, Wilmer Eye Institute, The Johns Hopkins Medical Institutions, Baltimore, MD
Transferido a
12 de outubro de 2022
DOI
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Licença
Creative Commons BY 4.0
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dgGaP phs000001.v3.p1 NEI Age-Related Eye Disease Study (AREDS)
The data table (n=142 variables) contains AMD and cataract phenotype information, medical history and socio-demographic information drawn from several data sets (e.g. enrollment_randomization, amdlensphenotype, followup), plus a unique patient identifier (ID2) for participants with a genetic specimen (to be found only in GENSPECPHENOTYPE and GENSPECFUNDUSLENS [pht000376] tables). Nuclear, cortical and posterior subcapsular opacity information is included for both eyes at baseline and end of study. Other disease information (e.g. diabetes, cancer, angina), medical information (e.g. BMI, blood pressure) and smoking status are also included annually throughout follow-up.
- StudyEvent: SEV1
- The data table (n=142 variables) contains AMD and cataract phenotype information, medical history and socio-demographic information drawn from several data sets (e.g. enrollment_randomization, amdlensphenotype, followup), plus a unique patient identifier (ID2) for participants with a genetic specimen (to be found only in GENSPECPHENOTYPE and GENSPECFUNDUSLENS [pht000376] tables). Nuclear, cortical and posterior subcapsular opacity information is included for both eyes at baseline and end of study. Other disease information (e.g. diabetes, cancer, angina), medical information (e.g. BMI, blood pressure) and smoking status are also included annually throughout follow-up.
- The data table (n=12 variables) contains information about the occurrence of adverse events during the AREDS clinical trial, e.g. type of adverse event, severity, primary ICD9 code, outcome, potential relationship to study drug, timing, and treatment. Data were collected through the clinical trial and for the first 6 months of the natural history follow-up immediately after the clinical trial concluded. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=25 variables) contains detailed information about cataract phenotypes (n=23 variables) as well as final AMD phenotype (n=1 variable), and patient ID. Nuclear, cortical and posterior subcapsular opacity information is included for both eyes at baseline and end of study. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=56 variables) contains information about AREDS participants' dietary intake of alcohol, amino acids, carbohydrates, fiber, poly- and monounsaturated fatty acids, proteins, vitamins and minerals. Participants' glycemic index and glycemic load are also included. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=102 variables) contains AREDS treatment assignment, basic socio-demographic characteristics and baseline medical history for AREDS participants. Medical history information includes eye disease information such as AMD Category, visual acuity, and past ophthalmic treatments (e.g. cataract surgery, laser treatment), as well as information about the presence/absence of other diseases (e.g. angina, arthritis, cancer, diabetes, high blood pressure), use of prescribed drugs for disease management (e.g. blood-thinning medications, digoxin, thyroid hormones, insulin), use of over-the-counter drugs (e.g. NSAIDs, antacids), intake of vitamins and minerals, and smoking history. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=83 variables) contains information obtained at follow-up visits during the AREDS clinical trial (every six months following randomization), annually in person during the natural history follow-up, and via phone between annual in-person visits. Variables include information about AREDS participants' ophthalmic medical history (e.g. cataract or other eye surgery, laser treatment for AMD, retinal repair, capsulotomy, presence/absence of lens, glaucoma, and visual acuity) and general medical information, including new diagnoses of cancer, heart disease, stroke, and peripheral vascular disease, disease history of angina and high blood pressure, current disease status of diabetes, arthritis, and gout, use of prescribed drugs for disease treatment or management (e.g. blood-thinning medications, digoxin, thyroid hormones, insulin), use of over-the-counter drugs (e.g. NSAIDs, antacids), and smoking behavior. For version 3 release of the study, visual acuity data of the right eye have been added for odd-numbered visits. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=49 variables) contains information from AREDS participants' fundus photographs, including presence, type, and extent of drusen, presence/extent of RPE depigmentation, SSR (serous sensory retinal) detachments, subretinal hemorrhages, subretinal fibrosis, and geographic atrophy. In addition, information on photocoagulation (PC) treatment for AMD SRNV is included, as well as AMD Severity Scale Scores and AMD Simple Scale Scores calculated from the fundus data. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=62) contains information only for AREDS participants who have a genetic specimen. A unique patient identifier (ID2 field) for these participants (to be found only in GENSPECPHENOTYPE [pht000001.v2.p1] and GENSPECFUNDUSLENS data tables) is included instead of the patient identifier used for data tables with all participants (ID field). Information about fundus and lens characteristics are included as follows - fundus: presence, type, and extent of drusen, presence/extent of RPE depigmentation, SSR (serous sensory retinal) detachments, subretinal hemorrhages, subretinal fibrosis, and geographic atrophy; lens: degree of nuclear sclerosis, cortical and posterior subcapsular opacities, and iris pigmentation. In addition, information on photocoagulation (PC) treatment for AMD is included as well as AMD Severity Scale Scores and AMD Simple Scale Scores calculated from the fundus data.
- The data table (n=6 variables) contains information about AREDS participant hospitalizations (e.g. reason, time from randomization, duration, primary ICD9 code) during the entire study. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=21 variables) contains information from AREDS participants' lens photographs, including degree of nuclear sclerosis, cortical and posterior subcapsular opacities, and iris pigmentation. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=7 variables) contains information about AREDS participant deaths (e.g. cause, time from randomization) during the entire study. A search using the National Death Index (NDI) yielded additional deaths not identified during the study. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=44 variables) contains information about AREDS participants' use (e.g. type, frequency, dose, duration) of non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen, acetaminophen, naproxen). Data were collected at in-clinic visits starting in October 2004. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=16 variables) contains information about AREDS participants' general vision status (e.g. general vision score, ocular pain score, VFQ overall score), and its effect on participants' behavior (e.g. near and distant activities, social activities, driving, mental health score) as obtained through the VFQ-25 questionnaire. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- Subject - Consent Information
- Subject - Sample Mapping (including mapping to Coriell IDs)
- The data table (n=2 variables) contains information on subjects' annual exposure to sunlight (hours; April through September).
- This dataset provides refractive error values obtained from control subjects of the AREDS study (phs000001.v3.p1) and represents a substudy of AREDS ; data of n=7 new variables are provided in addition to basic sociodemographic data. Subject - consent and subject - sample mapping information is available through phs000001.v3.p1.
- This dataset provides refractive error values obtained from control subjects of the AREDS study (phs000001.v3.p1) and represents a substudy of AREDS ; data of n=7 new variables are provided in addition to basic sociodemographic data. Subject - consent and subject - sample mapping information is available through phs000001.v3.p1.
- This dataset provides refractive error values obtained from control subjects of the AREDS study (phs000001.v3.p1) and represents a substudy of AREDS ; data of n=7 new variables are provided in addition to basic sociodemographic data. Subject - consent and subject - sample mapping information is available through phs000001.v3.p1.
Similar models
The data table (n=142 variables) contains AMD and cataract phenotype information, medical history and socio-demographic information drawn from several data sets (e.g. enrollment_randomization, amdlensphenotype, followup), plus a unique patient identifier (ID2) for participants with a genetic specimen (to be found only in GENSPECPHENOTYPE and GENSPECFUNDUSLENS [pht000376] tables). Nuclear, cortical and posterior subcapsular opacity information is included for both eyes at baseline and end of study. Other disease information (e.g. diabetes, cancer, angina), medical information (e.g. BMI, blood pressure) and smoking status are also included annually throughout follow-up.
- StudyEvent: SEV1
- The data table (n=142 variables) contains AMD and cataract phenotype information, medical history and socio-demographic information drawn from several data sets (e.g. enrollment_randomization, amdlensphenotype, followup), plus a unique patient identifier (ID2) for participants with a genetic specimen (to be found only in GENSPECPHENOTYPE and GENSPECFUNDUSLENS [pht000376] tables). Nuclear, cortical and posterior subcapsular opacity information is included for both eyes at baseline and end of study. Other disease information (e.g. diabetes, cancer, angina), medical information (e.g. BMI, blood pressure) and smoking status are also included annually throughout follow-up.
- The data table (n=12 variables) contains information about the occurrence of adverse events during the AREDS clinical trial, e.g. type of adverse event, severity, primary ICD9 code, outcome, potential relationship to study drug, timing, and treatment. Data were collected through the clinical trial and for the first 6 months of the natural history follow-up immediately after the clinical trial concluded. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=25 variables) contains detailed information about cataract phenotypes (n=23 variables) as well as final AMD phenotype (n=1 variable), and patient ID. Nuclear, cortical and posterior subcapsular opacity information is included for both eyes at baseline and end of study. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=56 variables) contains information about AREDS participants' dietary intake of alcohol, amino acids, carbohydrates, fiber, poly- and monounsaturated fatty acids, proteins, vitamins and minerals. Participants' glycemic index and glycemic load are also included. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=102 variables) contains AREDS treatment assignment, basic socio-demographic characteristics and baseline medical history for AREDS participants. Medical history information includes eye disease information such as AMD Category, visual acuity, and past ophthalmic treatments (e.g. cataract surgery, laser treatment), as well as information about the presence/absence of other diseases (e.g. angina, arthritis, cancer, diabetes, high blood pressure), use of prescribed drugs for disease management (e.g. blood-thinning medications, digoxin, thyroid hormones, insulin), use of over-the-counter drugs (e.g. NSAIDs, antacids), intake of vitamins and minerals, and smoking history. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=83 variables) contains information obtained at follow-up visits during the AREDS clinical trial (every six months following randomization), annually in person during the natural history follow-up, and via phone between annual in-person visits. Variables include information about AREDS participants' ophthalmic medical history (e.g. cataract or other eye surgery, laser treatment for AMD, retinal repair, capsulotomy, presence/absence of lens, glaucoma, and visual acuity) and general medical information, including new diagnoses of cancer, heart disease, stroke, and peripheral vascular disease, disease history of angina and high blood pressure, current disease status of diabetes, arthritis, and gout, use of prescribed drugs for disease treatment or management (e.g. blood-thinning medications, digoxin, thyroid hormones, insulin), use of over-the-counter drugs (e.g. NSAIDs, antacids), and smoking behavior. For version 3 release of the study, visual acuity data of the right eye have been added for odd-numbered visits. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=49 variables) contains information from AREDS participants' fundus photographs, including presence, type, and extent of drusen, presence/extent of RPE depigmentation, SSR (serous sensory retinal) detachments, subretinal hemorrhages, subretinal fibrosis, and geographic atrophy. In addition, information on photocoagulation (PC) treatment for AMD SRNV is included, as well as AMD Severity Scale Scores and AMD Simple Scale Scores calculated from the fundus data. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=62) contains information only for AREDS participants who have a genetic specimen. A unique patient identifier (ID2 field) for these participants (to be found only in GENSPECPHENOTYPE [pht000001.v2.p1] and GENSPECFUNDUSLENS data tables) is included instead of the patient identifier used for data tables with all participants (ID field). Information about fundus and lens characteristics are included as follows - fundus: presence, type, and extent of drusen, presence/extent of RPE depigmentation, SSR (serous sensory retinal) detachments, subretinal hemorrhages, subretinal fibrosis, and geographic atrophy; lens: degree of nuclear sclerosis, cortical and posterior subcapsular opacities, and iris pigmentation. In addition, information on photocoagulation (PC) treatment for AMD is included as well as AMD Severity Scale Scores and AMD Simple Scale Scores calculated from the fundus data.
- The data table (n=6 variables) contains information about AREDS participant hospitalizations (e.g. reason, time from randomization, duration, primary ICD9 code) during the entire study. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=21 variables) contains information from AREDS participants' lens photographs, including degree of nuclear sclerosis, cortical and posterior subcapsular opacities, and iris pigmentation. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=7 variables) contains information about AREDS participant deaths (e.g. cause, time from randomization) during the entire study. A search using the National Death Index (NDI) yielded additional deaths not identified during the study. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=44 variables) contains information about AREDS participants' use (e.g. type, frequency, dose, duration) of non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen, acetaminophen, naproxen). Data were collected at in-clinic visits starting in October 2004. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- The data table (n=16 variables) contains information about AREDS participants' general vision status (e.g. general vision score, ocular pain score, VFQ overall score), and its effect on participants' behavior (e.g. near and distant activities, social activities, driving, mental health score) as obtained through the VFQ-25 questionnaire. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
- Subject - Consent Information
- Subject - Sample Mapping (including mapping to Coriell IDs)
- The data table (n=2 variables) contains information on subjects' annual exposure to sunlight (hours; April through September).
- This dataset provides refractive error values obtained from control subjects of the AREDS study (phs000001.v3.p1) and represents a substudy of AREDS ; data of n=7 new variables are provided in addition to basic sociodemographic data. Subject - consent and subject - sample mapping information is available through phs000001.v3.p1.
- This dataset provides refractive error values obtained from control subjects of the AREDS study (phs000001.v3.p1) and represents a substudy of AREDS ; data of n=7 new variables are provided in addition to basic sociodemographic data. Subject - consent and subject - sample mapping information is available through phs000001.v3.p1.
- This dataset provides refractive error values obtained from control subjects of the AREDS study (phs000001.v3.p1) and represents a substudy of AREDS ; data of n=7 new variables are provided in addition to basic sociodemographic data. Subject - consent and subject - sample mapping information is available through phs000001.v3.p1.
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