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  1. 1. Klinische Studie
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
  4. 4. Qualitätssicherung
  5. 5. Datenstandard
  6. 6. Patientenfragebogen
  7. 7. Medizinische Fachrichtung
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dbGaP phs000428 Health and Retirement Study (HRS) - pht005036.v1.p2

- 29.01.25 - 6 forms, 1 itemgroup, 4 items, 1 language
Itemgroup: pht005036
Principal Investigator: David Weir, PhD, University of Michigan, Ann Arbor, MI, USA MeSH: Aging,Neoplasms,Arthritis,Lung Diseases, Obstructive,Dementia,Heart Diseases,Heart Failure,Hypertension,Myocardial Infarction,Diabetes Mellitus,Hypercholesterolemia,Obesity,Body Weight,Mobility Limitation,Pain,Cholesterol,Hemoglobin A, Glycosylated,C-Reactive Protein,Cystatin C,Depression,Alcohol Drinking,Smoking,Personality,Life Style,Cognition,Demography,Ethnic Groups,Health Status,Population Groups,Housing,Independent Living,Socioeconomic Factors,Career Mobility,Educational Status,Employment,Family Characteristics,Income,Occupations,Poverty,Social Change,Social Class,Social Conditions,Risk Factors https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000428 *Introduction to V2: *This data release comprises data from the V1 release combined with approximately 3,000 additional samples, collected during the HRS 2010 field period. The 2010 data include samples from a random half of the new cohort enrolled in 2010 along with a significant expansion of the minority sample. *Description:* The University of Michigan Health and Retirement Study (HRS) is a longitudinal panel study that surveys a representative sample of approximately 20,000 people in America over the age of 50 every two years. Supported by the National Institute on Aging (NIA U01AG009740) and the Social Security Administration, the HRS explores the changes in labor force participation and the health transitions that individuals undergo toward the end of their work lives and in the years that follow. The study collects information about income, work, assets, pension plans, health insurance, disability, physical health and functioning, cognitive functioning, and health care expenditures. Through its unique and in-depth interviews, the HRS provides an invaluable and growing body of multidisciplinary data that researchers can use to address important questions about the challenges and opportunities of aging. Because of its innovation and importance, the HRS has become the model and hub for a growing network of harmonized longitudinal aging studies around the world. *Origins of the HRS.* As the population ages it is increasingly important to obtain reliable data about aging and topics that are relevant to a range of policy issues in aging. To address this need, the National Institutes on Aging (NIA) established a cooperative agreement with the University of Michigan Institute for Social Research to collect such data. The HRS launched data collection in 1992 and has re-interviewed the original sample of respondents every two years since then. By adding new cohorts and refreshing the sample, the HRS has grown to become the largest, most representative longitudinal panel study of Americans 50 years and older. *HRS Study Design.* The target population for the original HRS cohort includes all adults in the contiguous United States born during the years 1931-1941 who reside in households, with a 2:1 oversample of African-American and Hispanic populations. The original sample is refreshed with new birth cohorts (51-56 years of age) every six years. The sample has been expanded over the years to include a broader range of birth cohorts as well. The target population for the AHEAD survey consists of United States household residents who were born in 1923 or earlier. Children of the Depression (CODA) recruits households born 1924-1930, War Babies 1942-47, Early Boomers 1948-53, and Mid-Boomers 1954-59. Data collection includes a mixed mode design combining in-person, telephone, mail, and Internet. For consenting respondents, HRS data are linked at the individual level to administrative records from Social Security and Medicare claims. *Genetic Research in the HRS.* The HRS has genotyped 2.5 million single nucleotide polymorphisms (SNPs) on respondents using Illumina's Human Omni2.5-Quad (Omni2.5) BeadChip. The genotyping was performed by the NIH Center for Inherited Disease Research (CIDR). Saliva was collected on half of the HRS sample each wave starting in 2006. In 2006, saliva was collected using a mouthwash collection method. From 2008 onward, the data collection method switched to the Oragene kit. Saliva completion rates were 83% in 2006, 84% in 2008, and 80% in 2010 among new cohort enrollees. HRS Phenotypic data. Phenotypic data are available on a variety of dimensions. Health measures include physical/psychological self-report, various health conditions, disabilities, cognitive performance, health behaviors (smoking, drinking, exercise), physical performance and anthropomorphic measures, and biomarkers (HbA1c, Total Cholesterol, HDL, CRP, Cystatin-C). Data are also available on health services including utilization, insurance and out-of-pocket spending with linkage to Medicare records. Economic measures include employment status/history, earnings, disability, retirement, type of work, income by source, wealth by asset type, capital gains/debt, consumption, linkage to pensions, Social Security earnings/benefit histories. There is also extensive information on family structure, proximity, transfers to/from of money, time, social and psychological characteristics, as well as a wide range of demographics. Performance on a cognitive test combining immediate and delayed word recall was selected as an example trait for the dbGaP data release. In the immediate word recall task the interviewer reads a list of 10 nouns to the respondent and asks the respondent to recall as many words as possible from the list in any order. After approximately five minutes of asking other survey questions, the respondent is asked to recall the nouns previously presented as part of the immediate recall task. The total recall score is the sum of the correct answers to these two tasks, with a range of 0 to 20. Researchers who wish to link to other HRS measures not in dbGaP will be able to apply for access from HRS. A separate Data Use Agreement (DUA) will be required for linkage to the HRS data. See the HRS website (http://hrsonline.isr.umich.edu/gwas) for details.

Eligibility

1 itemgroup 6 items

pht002612.v2.p2

1 itemgroup 4 items

pht002613.v2.p2

1 itemgroup 5 items

pht002614.v2.p2

1 itemgroup 7 items

pht005037.v1.p2

1 itemgroup 5 items

ICHOM Heart Failure - Baseline Characteristics, at time of index event

- 30.04.20 - 1 form, 5 itemgroups, 62 items, 1 language
Itemgroups: Patient ID, Demographic Factors, Baseline health status, Treatment variables, Burden of Care
HEART FAILURE DATA COLLECTION Version 1.1.4 Revised October 31st, 2017 www.ichom.org Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Heart Failure Treatment Approaches: Pharmacotherapy | Invasive Therapy | Rehabilitation This ODM-file contains baseline characteristics. It should be filled in at the time of the index event. The index event represents the entry into the set. This could either be after diagnosis/first encounter in an outpatient setting, or at discharge from hospital if the initial presentation was severe enough to require admission. Use of the following Scores for this standard set: KCCQ-12: Kansas City Cardiomyopathy Questionnaire-Short Version: You can obtain a license to use this instrument at your institution by visiting http://cvoutcomes.org/licenses NYHA – New York Heart Association Functional Classification: The NYHA is free for all health care organizations, and a license is not needed. PROMIS Physical Function Short Form 4a – Patient-Reported Outcome Measurement Information System: PROMIS Physical Function is free for all health care organizations, and a license is not needed. For more information, please visit http://www.healthmeasures.net/explore-measurement-systems/promis/obtain-administer-measures . As http://www.nihpromis.org/ is the official distribution site for PROMIS questionnaires and translations, only the total score will be included in this version of the standard set. Patient Health Questionnaire (PHQ-2): Copyright by Pfizer: "content found on the PHQ Screeners site is free for download and use as stated within the PHQ Screeners site, please visit http://www.phqscreeners.com/ for more information. ICHOM was supported for the Heart Failure Standard Set by GIG Cymru NHS Wales, American Heart Association, British Heart Foundation, Heart Failure Association of the ESC and European Society of Cardiology. Publication: Burns DJP, Arora J, Okunade O, Beltrame JF, Bernardez-Pereira S, Crespo-Leiro MG, et al. International Consortium for Health Outcomes Measurement (ICHOM): Standardized Patient-Centered Outcomes Measurement Set for Heart Failure Patients. JACC: Heart Failure. 2020 Mar 1;8(3):212–22. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

dbGaP phs000090 The Atherosclerosis Risk in Communities (ARIC) Study - pht001035.v1.p1

- 12.10.22 - 3 forms, 1 itemgroup, 4 items, 1 language
Itemgroup: pht001035.v1.p1
https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000090 The Atherosclerosis Risk in Communities (ARIC) Study, sponsored by the National Heart, Lung and Blood Institute (NHLBI), is a prospective epidemiologic study conducted in four U.S. communities. The four communities are Forsyth County, NC; Jackson, MS; the northwest suburbs of Minneapolis, MN; and Washington County, MD. ARIC is designed to investigate the etiology and natural history of atherosclerosis, the etiology of clinical atherosclerotic diseases, and variation in cardiovascular risk factors, medical care and disease by race, gender, location, and date. ARIC includes two parts: the Cohort Component and the Community Surveillance Component. The Cohort Component began in 1987, and each ARIC field center randomly selected and recruited a cohort sample of approximately 4,000 individuals aged 45-64 from a defined population in their community. A total of 15,792 participants received an extensive examination, including medical, social, and demographic data. These participants were reexamined every three years with the first screen (baseline) occurring in 1987-89, the second in 1990-92, the third in 1993-95, and the fourth and last exam was in 1996-98. Follow-up occurs yearly by telephone to maintain contact with participants and to assess health status of the cohort. In the Community Surveillance Component, currently ongoing, these four communities are investigated to determine the community-wide occurrence of hospitalized myocardial infarction and coronary heart disease deaths in men and women aged 35-84 years. Hospitalized stroke is investigated in cohort participants only. Starting in 2006, the study conducts community surveillance of inpatient (ages 55 years and older) and outpatient heart failure (ages 65 years and older) for heart failure events beginning in 2005. ARIC is currently funded through January 31, 2012. This study is part of the Gene Environment Association Studies initiative (GENEVA, http://www.genevastudy.org) funded by the trans-NIH Genes, Environment, and Health Initiative (GEI). The overarching goal is to identify novel genetic factors that contribute to atherosclerosis and cardiovascular disease through large-scale genome-wide association studies of well-characterized cohorts of adults in four defined populations. Genotyping was performed at the Broad Institute of MIT and Harvard, a GENEVA genotyping center. Data cleaning and harmonization were done at the GEI-funded GENEVA Coordinating Center at the University of Washington.

pht000114.v1.p1

1 itemgroup 362 items

pht001036.v1.p1

1 itemgroup 4 items

Persönliches Interview SHIP-Trend-1 Herzinsuffizienz

- 13.02.21 - 1 form, 1 itemgroup, 11 items, 1 language
Itemgroup: Herzinsuffizienz
Herzinsuffizienz form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name TREND.TREND1.INT.KHK.HERZ. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

Telemedical Interventional Management in Heart Failure II (TIM-HF II) NCT01878630 - End of study Cardiology

- 14.11.17 - 1 form, 2 itemgroups, 15 items, 2 languages
Itemgroups: Regular end of study, Early termination of study
Short title: TIM-HF II Permission to publish granted by: Prof. Dr. Friedrich Köhler, FESC Charité - Universitätsmedizin Berlin Further study details on: https://www.clinicaltrials.gov/ct2/show/NCT01878630 End of study Cardiology (ES-form)

Endpoint Hospitalisation for heart failure GSK study Chronic Coronary Heart Disease NCT00799903

- 20.09.21 - 1 form, 3 itemgroups, 43 items, 1 language
Itemgroups: Investigator section, CEC Section, CEC Status
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Endpoint Hospitalisation for heart failure - Repeating form (Scheduled visits)

CEC - Hospitalisation for heart failure GSK study Chronic Coronary Heart Disease NCT00799903

- 11.01.18 - 1 form, 3 itemgroups, 18 items, 1 language
Itemgroups: CEC - Hospitalisation for heart failure, Hospitalisation for heart failure - CEC Section, CEC Status
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: CEC - Hospitalisation for heart failure Repeating form (Scheduled visits)

Swedish Heart Failure Registry (RiksSvikt) - SHFR Hospital

- 20.09.21 - 1 form, 9 itemgroups, 93 items, 2 languages
Itemgroups: Demography and Lifestyle, Patient self rated symptoms, Previous diseases, Performed procedures, Diagnostics, Biometrics and physical signs, Medication treatment, Patient and relative Information, Planned Follow-Up
Swedish Heart Failure Registry (RiksSvikt/SwedeHF) Sweden has a long tradition of measuring results and performance of the given health care. In order to stimulate to achieve better results, we try to find explanations for the discrepancies between different regions/hospitals/primary care units. In recent years, quality registries have become an increasingly important source of Swedish clinical research. SwedeHF (or RiksSvikt) was created in order to give the participating units knowledge, about how they diagnosed and treated their patients. The given information obtains indications where further efforts are needed in order to give patients with heart failure an optimal management. SwedeHF is an Internet-based registry, where participating units register their heart failure patient on-line, using transferred data from standardized forms or from computerized patients records. SHFR Hospital

dbGaP phs000974 NHLBI TOPMed: Whole Genome Sequencing and Related Phenotypes in the Framingham Heart Study - Eligibility

- 01.12.23 - 4 forms, 1 itemgroup, 1 item, 1 language
Itemgroup: IG.elig
Principal Investigator: Vasan Ramachandran, Department of Medicine, Boston University School of Medicine, Boston, MA, USA MeSH: Cardiovascular Diseases,Atherosclerosis,Atrial Fibrillation,Death, Sudden, Cardiac,Diabetes Mellitus, Type 2,Heart Failure,Blood Pressure,Hypertension,Body Mass Index,Adiposity,Lipids,Pulmonary Disease, Chronic Obstructive,Renal Insufficiency, Chronic,Stroke,Osteoporosis,Risk Factors,Biological Markers,Biomarkers, Pharmacological https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000974 The Framingham Heart Study (FHS) is a prospective cohort study of 3 generations of subjects who have been followed up to 65 years to evaluate risk factors for cardiovascular disease. Its large sample of ~15,000 men and women who have been extensively phenotyped with repeated examinations make it ideal for the study of genetic associations with cardiovascular disease risk factors and outcomes. DNA samples have been collected and immortalized since the mid-1990s and are available on ~8000 study participants in 1037 families. These samples have been used for collection of GWAS array data and exome chip data in nearly all with DNA samples, and for targeted sequencing, deep exome sequencing and light coverage whole genome sequencing in limited numbers. Additionally, mRNA and miRNA expression data, DNA methylation data, metabolomics and other 'omics data are available on a sizable portion of study participants. This project will focus on deep whole genome sequencing (mean 30X coverage) in ~4100 subjects and imputed to all with GWAS array data to more fully understand the genetic contributions to cardiovascular, lung, blood and sleep disorders. Comprehensive phenotypic and pedigree data for study participants are available through dbGaP phs000007.

pht004909.v3.p3

1 itemgroup 2 items

pht004910.v4.p3

1 itemgroup 2 items

pht004911.v3.p3

1 itemgroup 9 items

Study Title: Telemedical Interventional Management in Heart Failure II (TIM-HF II) NCT01878630 - Screening-Visit

- 14.11.17 - 1 form, 6 itemgroups, 43 items, 2 languages
Itemgroups: Screening Visit, Inclusion criteria, Exclusion criteria, Screening visit information, Section to be completed by cardiologist after baseline visit, Screening result
Short title: TIM-HF II Permission to publish granted by: Prof. Dr. Friedrich Köhler, FESC Charité - Universitätsmedizin Berlin Further study details on: https://www.clinicaltrials.gov/ct2/show/NCT01878630 Screening-Visit (S-Form)

ICHOM Heart Failure - Clinician-reported Outcome

- 30.04.20 - 1 form, 6 itemgroups, 46 items, 1 language
Itemgroups: Administrative Data, Baseline health status, Treatment variables, Degree of Health, Burden of Care, Mortality
HEART FAILURE DATA COLLECTION Version 1.1.4 Revised October 31st, 2017 www.ichom.org Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Heart Failure Treatment Approaches: Pharmacotherapy | Invasive Therapy | Rehabilitation This ODM-file contains clinician-reported outcome variables. It should be tracked 6-monthly for life, starting 30 days and 6 months post-index event. The collection rhythm has to be reset in case of an acute admission (including complications): It should be collected during the acute admission, 30 days post-discharge, 6 months following last admission and 6 monthly from then on. Use of the following Scores for this standard set: KCCQ-12: Kansas City Cardiomyopathy Questionnaire-Short Version: You can obtain a license to use this instrument at your institution by visiting http://cvoutcomes.org/licenses NYHA – New York Heart Association Functional Classification: The NYHA is free for all health care organizations, and a license is not needed. PROMIS Physical Function Short Form 4a – Patient-Reported Outcome Measurement Information System: PROMIS Physical Function is free for all health care organizations, and a license is not needed. For more information, please visit http://www.healthmeasures.net/explore-measurement-systems/promis/obtain-administer-measures . As http://www.nihpromis.org/ is the official distribution site for PROMIS questionnaires and translations, only the total score will be included in this version of the standard set. Patient Health Questionnaire (PHQ-2): Copyright by Pfizer: "content found on the PHQ Screeners site is free for download and use as stated within the PHQ Screeners site, please visit http://www.phqscreeners.com/ for more information. ICHOM was supported for the Heart Failure Standard Set by GIG Cymru NHS Wales, American Heart Association, British Heart Foundation, Heart Failure Association of the ESC and European Society of Cardiology. Publication: Burns DJP, Arora J, Okunade O, Beltrame JF, Bernardez-Pereira S, Crespo-Leiro MG, et al. International Consortium for Health Outcomes Measurement (ICHOM): Standardized Patient-Centered Outcomes Measurement Set for Heart Failure Patients. JACC: Heart Failure. 2020 Mar 1;8(3):212–22. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Heart Failure - Patient-reported Outcome

- 30.04.20 - 1 form, 3 itemgroups, 7 items, 1 language
Itemgroups: Administrative Data, Degree of Health, Burden of Care
HEART FAILURE DATA COLLECTION Version 1.1.4 Revised October 31st, 2017 www.ichom.org Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Heart Failure Treatment Approaches: Pharmacotherapy | Invasive Therapy | Rehabilitation This ODM-file contains patient-reported outcome variables. It should be tracked 6-monthly for life, starting 30 days and 6 months post-index event. The collection rhythm has to be reset after an acute admission (including complications), starting anew at 30 days post-discharge and 6 months post-hospital admission, and tracked 6-monthly from then on. Use of the following Scores for this standard set: KCCQ-12: Kansas City Cardiomyopathy Questionnaire-Short Version: You can obtain a license to use this instrument at your institution by visiting http://cvoutcomes.org/licenses NYHA – New York Heart Association Functional Classification: The NYHA is free for all health care organizations, and a license is not needed. PROMIS Physical Function Short Form 4a – Patient-Reported Outcome Measurement Information System: PROMIS Physical Function is free for all health care organizations, and a license is not needed. For more information, please visit http://www.healthmeasures.net/explore-measurement-systems/promis/obtain-administer-measures . As http://www.nihpromis.org/ is the official distribution site for PROMIS questionnaires and translations, only the total score will be included in this version of the standard set. Patient Health Questionnaire (PHQ-2): Copyright by Pfizer: "content found on the PHQ Screeners site is free for download and use as stated within the PHQ Screeners site, please visit http://www.phqscreeners.com/ for more information. ICHOM was supported for the Heart Failure Standard Set by GIG Cymru NHS Wales, American Heart Association, British Heart Foundation, Heart Failure Association of the ESC and European Society of Cardiology. Publication: Burns DJP, Arora J, Okunade O, Beltrame JF, Bernardez-Pereira S, Crespo-Leiro MG, et al. International Consortium for Health Outcomes Measurement (ICHOM): Standardized Patient-Centered Outcomes Measurement Set for Heart Failure Patients. JACC: Heart Failure. 2020 Mar 1;8(3):212–22. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

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