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REFLECT-1 Visit 4 NCT00428090

- 25.09.16 - 1 Formular, 12 Itemgruppen, 24 Datenelemente, 1 Sprache
Itemgruppen: Patient Information, Investigator Instructions, Subject Continuation, Vital signs, Central Laboratory, Concomitant medication, Adverse Event, Physical Examination, Pedal Oedema, Investigational Product, Compliance, End of Visit Reminder
NCT00428090 / GSK-AVA105640 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1)

Indigenous primary health care DSS 2015- Metadata Online Registry (METeOR)

- 07.09.16 - 1 Formular, 11 Itemgruppen, 59 Datenelemente, 1 Sprache
Itemgruppen: Address, Birth event, Birth, Child, Female, Organisation, Person, Pregnancy, Service provider organisation (address), Service provider organisation (name), Service provider organisation
Health sector data set specifications from METeOR, Australia's repository for national metadata standards, developed by the Australian Institute of Health and Welfare (http://meteor.aihw.gov.au/content/index.phtml/itemId/345165) Indigenous primary health care DSS 2015-: The Indigenous primary health care data set specification (IPHC DSS) is primarily designed to support the collection of aggregate information from Indigenous-specific primary health care services. The IPHC DSS describes the aggregate data to be reported by those Indigenous-specific primary health care services. Only the data, which services aggregate using cohort definitions and specialised software, will be supplied through the OATSIH Community Health Reporting Environment (OCHRE), a web-based reporting tool. No individual level client data will be supplied to either the Australian Institute of Health and Welfare (AIHW) or the Commonwealth Department of Health. For the purposes of the IPHC DSS, Aboriginal and Torres Strait Islander primary health care is defined as: “…socially and culturally appropriate, universally accessible, scientifically sound, first level care. It is provided by health services and systems with a suitably trained workforce comprised of multidisciplinary teams supported by integrated referral systems in a way that: gives priority to those most in need and addresses health inequalities; maximises community and individual self-reliance, participation and control and; involves collaboration and partnership with other sectors to promote public health. Comprehensive primary health care includes health promotion, illness prevention, treatment, and care of the sick, community development, advocacy, and rehabilitation services.” This definition has been endorsed by the Aboriginal Medical Services Alliance of the Northern Territory (AMSANT), the Australian General Practice Network (AGPN), the Australian Primary Health Care Research Institute (APHCRI), and the Australian Medical Association (AMA). Aboriginal and Torres Strait Islander primary health care services include: 1. Aboriginal Community Controlled Health Service (ACCHS): primary health care services initiated and operated by the local Aboriginal community to deliver holistic, comprehensive, and culturally appropriate health care to the community which controls it (through a locally elected Board of Management); and 2. Other Aboriginal and Torres Strait Islander primary health care services: health services funded principally to provide services to Aboriginal and Torres Strait Islander individuals with funding provided by the federal and/or state or territory governments. These non community-controlled services mainly exist in the Northern Territory and northern part of Queensland. Services use a clinical audit tool program for extracting and aggregating data from their patient information and recall systems. The IPHC DSS has been written to inform this program. Once aggregated, the data will be sent to the AIHW via the OATSIH Community Health Reporting Environment (OCHRE), a web-based reporting tool with an ‘in-confidence’ security classification. The IPHC DSS includes aggregate data only; it does not include data elements describing any details relating to or arising from individual client visits, at the client visit level, e.g. blood pressure measurements, body mass index (BMI) values and so on. Aggregate data was initially collected from a limited number of primary health care services, i.e. those funded by the Office for Aboriginal and Torres Strait Islander Health (OATSIH) via the Healthy for Life program. From mid-2012, data collection was extended to the remainder of services funded by OATSIH to deliver primary health care. From mid-2013, data collection was expanded to also include state- and territory-funded Indigenous-specific primary health care services not funded by OATSIH. Institute of Health and Welfare GPO Box 570 Canberra ACT 2601

Acute coronary syndrome (clinical) DSS 2013- Metadata Online Registry (METeOR)

- 02.09.16 - 1 Formular, 10 Itemgruppen, 84 Datenelemente, 1 Sprache
Itemgruppen: Acute coronary syndrome clinical event cluster, Emergency department stay, Episode of admitted patient care, Episode of care, Establishment, Health service event, Laboratory standard, Non-admitted patient emergency department service episode, Person with acute coronary syndrome, Person
Health sector data set specifications from METeOR, Australia's repository for national metadata standards, developed by the Australian Institute of Health and Welfare (http://meteor.aihw.gov.au/content/index.phtml/itemId/345165) Acute coronary syndrome (clinical) DSS 2013- The Acute coronary syndrome (ACS) data set specification is not mandated for collection but is recommended as best practice if ACS data are to be collected. This data set specification enables individual hospitals or health service areas to develop collection methods and policies appropriate for their service. The scope for the ACS data set specification is to collect data on the period between when a person with ACS symptoms was first referred to a hospital or directly presented at a hospital, and when a person leaves the hospital, either from the emergency department or is discharged from the hospital. Some of the data relevant to the management of patients attending hospital with ACS symptoms is specified for collection at follow-up visits with a specialist or as a non-admitted patient. Acute coronary syndromes reflect the spectrum of coronary artery disease resulting in acute myocardial ischaemia, and span unstable angina, non-ST segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI). Clinically these diagnoses encompass a wide variation in risk, require complex and time urgent risk stratification and represent a large social and economic burden. The definitions used in this data set specification are designed to underpin the data collected by health professionals in their day-to-day acute care practice. They relate to the realities of an acute clinical consultation for patients presenting with chest pain/discomfort and the need to correctly identify, evaluate and manage patients at increased risk of a coronary event. The data elements specified in this metadata set provide a framework for: • promoting the delivery of evidenced-based acute coronary syndrome management care to patients; • facilitating the ongoing improvement in the quality and safety of acute coronary syndrome management in acute care settings in Australia and New Zealand; • improving the epidemiological and public health understanding of this syndrome; and • supporting acute care services as they develop information systems to complement the above. This is particularly important, as the scientific evidence supporting the development of the data elements within the ACS data set specification indicate that accurate identification of the evolving myocardial infarction patient or the high/intermediate risk patient leading to the implementation of the appropriate management pathway impacts on the patient's outcome. Having a nationally recognised set of definitions in relation to defining a patient's diagnosis, risk status and outcomes is a prerequisite to achieving the above aims. The ACS data set specification is based on the American College of Cardiology (ACC) Data Set for Acute Coronary Syndrome as published in the Journal of the American College of Cardiology in December 2001 (38:2114-30) as well as more recent scientific evidence around the diagnosis of myocardial infarction presented in the National Heart Foundation of Australia/Cardiac Society of Australia and New Zealand Guidelines for the management of acute coronary syndromes (MJA 2006;184;S1-S32). The data elements are alphabetically listed and grouped in a similar manner to the American College of Cardiology's data set format. These features of the Australian ACS data set should ensure that the data is internationally comparable. Many of the data elements in this data set specification may also be used in the collection of other cardiovascular clinical information. Where appropriate, it may be useful if the data definitions in this data set specification were also used to address data definition needs in non-clinical environments such as public health surveys etc. This could allow for qualitative comparisons between data collected in, and aggregated from, clinical settings (i.e. using application of the ACS data set specification), with that collected through other means (e.g. public health surveys, reports). A set of ACS data elements and standardised definitions can inform the development and conduct of future registries at both the national and local level. The working group formed under the National Heart Foundation of Australia (Heart Foundation) and the Cardiac Society of Australia and New Zealand (CSANZ) initiative was diverse and included representation from the following organisations: the Heart Foundation, the CSANZ, the Australasian College of Emergency Medicine, the Australian Institute of Health and Welfare, the Australasian Society of Cardiac & Thoracic Surgeons, Royal Australian College of Physicians (RACP), RACP - Towards a Safer Culture, National Centre for Classification in Health (Brisbane), the NSW Aboriginal Health & Medical Research Council, the George Institute for International Health, the School of Population Health at the University of Western Australia and the National Cardiovascular Monitoring System Advisory Committee. To ensure the broad acceptance of the data set specification, the working group also sought consultation from the heads of cardiology departments, other specialist professional bodies and regional key opinion leaders in the field of acute coronary syndromes. Metadata and Classifications Unit Australian Institute of Health and Welfare GPO Box 570 Canberra ACT 2601

Vital Signs: CRF QMCR University of Alberta

- 20.08.16 - 1 Formular, 1 Itemgruppe, 26 Datenelemente, 1 Sprache
Itemgruppe: General Information
ODM derived from: http://www.qmcr.ualberta.ca/en/ToolsandTemplates/CaseReportFormCRFTemplates.aspx. Template Name: Vital Signs. University of Alberta, Quality Management in Clinical Research. Copyright: 2002-2016 University of Alberta.

Vital signs: UIC Quality Improvement CRF

- 17.08.16 - 1 Formular, 2 Itemgruppen, 31 Datenelemente, 1 Sprache
Itemgruppen: General information, Vital signs
ODM derived from: http://research.uic.edu/qip/toolbox/case-report-forms-crf. Template Name: Vital signs. QIP Case Report Forms, UIC Quality Improvement CRF, Office of the Vice Chancellor for Research. Center for Clinical and Translational Science, UIC University of Illinois at Chicago.

Physical Exam: UIC Quality Improvement CRF

- 17.08.16 - 1 Formular, 2 Itemgruppen, 50 Datenelemente, 1 Sprache
Itemgruppen: General Information, Physical Exam
ODM derived from: http://research.uic.edu/qip/toolbox/case-report-forms-crf. Template Name: Physical Exam. QIP Case Report Forms, UIC Quality Improvement CRF, Office of the Vice Chancellor for Research. Center for Clinical and Translational Science, UIC University of Illinois at Chicago.

Physical Examinations MIPSO EudraCT 2014-003022-4 DRKS00007147 - Physical Examinations MIPSO EudraCT 2014-003022-4

- 25.07.16 - 1 Formular, 5 Itemgruppen, 37 Datenelemente, 1 Sprache
Itemgruppen: Use of the form, Physical Examination, Identification of plaques for sampling, Screening/Termination visit, Laboratory tests
MIPSO Comparative study of bacterial microbiota in the skin and intestines of psoriasis patients before and after systemic treatment with adalimumab or ustekinumab or ciclosporin (EudraCT 2014-003022-40) Principal Investigator: Prof. Dr. Dr. H. C. Thomas A. Luger

Study hospital, Medical Faculty Münster- Clinical Examination findings - Clinical Examination findings

- 21.07.16 - 1 Formular, 25 Itemgruppen, 138 Datenelemente, 2 Sprachen
Itemgruppen: Demographics, General Health assessment, Skin assessment, Head assessment, Assessment of Lymph nodes, Eyes, Ears, Nose, Oral cavity, Neck, Thorax, Lungs, Heart, Abdominal Examination, Liver, Spleen, Fibrous capsule of kidney, Rectal examination, Genitalia, Extremities, Vascular status, Neurologic status, Central nervous system, Peripheral nervous system, Diagnosis
Medical history form, Study hospital, Medical Faculty Münster derived from Medical history form by Dr. Schusdziarra

Physical Exam Cardiovascular Health Study (CHS)

- 19.07.16 - 1 Formular, 6 Itemgruppen, 42 Datenelemente, 1 Sprache
Itemgruppen: Measured Walk, Grip Strength, General Physical Examination, Chair stands, Other physical findings/comments, Date of interview
Documentation part: Record 17 Physical Exam The Cardiovascular Health Study (CHS) was initiated by the National Heart, Lung and Blood Institute (NHLBI) in 1987 to determine the risk factors for development and progression of cardiovascular disease (CVD) in older adults, with an emphasis on subclinical measures. The study recruited 5,888 adults aged 65 or older at entry in four U.S. communities and conducted extensive annual clinical exams between 1989-1999 along with semi-annual phone calls, events adjudication, and subsequent data analyses and publications. Additional data were collected by studies ancillary to CHS. With the exception of annual clinic visits, these activities are still ongoing. Data obtained from: https://chs-nhlbi.org/ Permission granted by: Erika Enright.

Emergency Room Point B in Time Part 2: Emergency Room Report UKM

- 03.07.16 - 1 Formular, 13 Itemgruppen, 105 Datenelemente, 2 Sprachen
Itemgruppen: Patient information, Physical examination result, ATLS, Peripheral neurological status, Vascular examination, Physical examination of head, Physical examination of thorax, Physical examination of abdomen and genitourinary system, Physical examination of pelvis, Physical examination of limbs, Diagnoses, Patient handover, Work-related accident
Report/Protocol collecting patient and treatment information like the circumstances of the accident and initial ER treatment. http://klinikum.uni-muenster.de/

NINDS CDE Physical Exam Multiple Sclerosis - Physical Exam

- 29.06.16 - 1 Formular, 2 Itemgruppen, 48 Datenelemente, 1 Sprache
Itemgruppen: Physical Exam, Physical examination Results
NINDS Common Data Elements, Multiple Sclerosis Physical Exam Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

NINDS CDE Physical Examination Headache - Physical Examination

- 20.06.16 - 1 Formular, 1 Itemgruppe, 48 Datenelemente, 1 Sprache
Itemgruppe: Physical Exam
NINDS Common Data Elements [Physical Examination] [Headache] Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

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