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  1. 1. Essai clinique
  2. 2. Routinedokumentation
  3. 3. Études de registres/cohortes
  4. 4. Assurance qualité
  5. 5. Standard de données
  6. 6. Questionnaire pour les patients
  7. 7. Spécialité médicale
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eWundbericht (electronic wound report) - Body - Therapie (therapy)

- 20/09/2021 - 4 Formulare, 9 Itemgruppen, 26 Datenelemente, 2 Sprachen
Itemgruppen: Treatment goals, Treatment plan, Equipment and Resources, Healing and therapy process, Hygiene activity, Wound protection, Therapy, causal, Education of patient and relatives, Treatment results, preliminary
eWundbericht Prof. Dr. Ursula Hübner Forschungsgruppe Informatik im Gesundheitswesen Hochschule Osnabrück Fakultät Wirtschafts- und Sozialwissenschaften http://wiki.hl7.de/index.php/EWundbericht_(Projekt)

Body - Anamnese (medical history)

11 Itemgruppen 36 Datenelemente

Body - Diagnose (diagnosis)

2 Itemgruppen 6 Datenelemente

Header

3 Itemgruppen 18 Datenelemente

Screening - GSK Milveterol COPD 100527

- 20/09/2021 - 1 Formular, 9 Itemgruppen, 132 Datenelemente, 1 Sprache
Itemgruppen: Inclusion/Exclusion criteria, Demography, Duration of Asthma, Vital Signs, 12-Lead Electrocardiogram, Pulmonary function, Hematology, Clinical Chemistry, Urinalysis
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

NCI Standard Demography Template

- 20/09/2021 - 1 Formular, 3 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: Demography, Demography, conditional, Demography, optional
The collection of CDEs used in the demography module. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=74E63D0F-0BF0-E8D1-E040-BB89AD430251

Emergency protocol- Module Anesthesia - Measures in recovery room

- 20/09/2021 - 3 Formulare, 1 Itemgruppe, 13 Datenelemente, 1 Sprache
Itemgruppe: Measures in recovery room
Emergency protocol by the DIVI (Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin). ODM derived from “Notaufnahmeprotokoll Modul Anästhesie”.

Anesthesia

3 Itemgruppen 50 Datenelemente

Anaesthesia technique

1 Itemgruppe 5 Datenelemente

NINDS CDE Demographics Multiple Sclerosis - Demographics

- 15/03/2021 - 1 Formular, 1 Itemgruppe, 8 Datenelemente, 1 Sprache
Itemgruppe: Demographics
NINDS Common Data Elements, Multiple Sclerosis Demographics 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.

Sepsis Case Report Form MEDUSA project - SAPS II- Score Report Form

- 17/11/2020 - 1 Formular, 2 Itemgruppen, 8 Datenelemente, 1 Sprache
Itemgruppen: Header module, SAPS II- Score
The MEDUSA project (medical education for sepsis source control and antibiotics) is a scientific study of the integrated research and treatment center "Center for Sepsis Control and Care" (CSCC) of the University Hospital Jena, Thuringia, Germany. Its aim is to investigate whether a multimodal and interdisciplinary training concept for the early recognition and standardized treatment of patients with sepsis improves time to administration of first antibiotic and survival of patients. Original forms obtained from: http://www.medusa.uniklinikum-jena.de/Datenerfassung.html

Smart Device System Meta Data Definitions - Neurologic Examination

- 03/09/2020 - 7 Formulare, 1 Itemgruppe, 6 Datenelemente, 2 Sprachen
Itemgruppe: Neurologic examination
Metadata definitions for the Smart Device System for Movement Disorders. Clinical Protocol and Registration Information available on: https://clinicaltrials.gov/ct2/show/NCT03638479 Principal Investigator: Julian Varghese Description for Assessment Steps for Neurologic Examination are available under: Varghese J, Niewöhner S, Soto-Rey I, et al. A Smart Device System to Identify New Phenotypical Characteristics in Movement Disorders. Front Neurol. 2019;10:48. doi:10.3389/fneur.2019.00048

Family History

1 Itemgruppe 2 Datenelemente

Medication

1 Itemgruppe 3 Datenelemente

Vital Signs

1 Itemgruppe 1 Datenelement

PD NMS

1 Itemgruppe 1 Datenelement

Demography

2 Itemgruppen 5 Datenelemente

Medical History

1 Itemgruppe 9 Datenelemente

Patient reported outcome measures in ATTR amyloidosis - PROMs in ATTR amyloidosis

- 06/08/2020 - 1 Formular, 8 Itemgruppen, 76 Datenelemente, 1 Sprache
Itemgruppen: Demographic Factors, Comorbidities, Patient reported outcomes: ATTR Diagnosis, First organ system involved, Patient reported outcomes: Quality of life, Patient reported outcomes: Disability, Patient reported Outcomes: ATTR Management, ATTR Therapy
Patient reported outcome measures (PROMS) in patients with ATTR amyloidosis Dr. med. Fabian Johannes Bolte Klinik für Gastroenterologie und Hepatologie Universitätsklinikum Münster Conditions: ATTR Amyloidosis This form is used for patient reported outcome measures (PROMS) in patients with ATTR amyloidosis to understand patients challenges and needs. Use of the following Scores for this standard set: (1) Patient Reported Outcomes Measurement Information System Short Form version 1.1 Global Health (PROMIS-10) (2) World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)- 12-item Instrument

Measurement Instrument Database for the Social Science (MIDSS) - Social Anxiety Questionnaire for Adults (SAQ-A30)

- 25/06/2020 - 1 Formular, 2 Itemgruppen, 34 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, SOCIAL ANXIETY QUESTIONNAIRE FOR ADULTS
Caballo, V. E., Salazar, I. C., Irurtia, M. J., Arias, B., and CISO-A Research Team. (2012) . Social Anxiety Questionnaire for Adults (SAQ-A30) . Measurement Instrument Database for the Social Science. Retrieved 25.06.2020 from www.midss.ie Key references: Caballo, V. E., Salazar, I. C., Arias, B., Irurtia, M. J., Calderero, M., & the CISO-A Research Team Spain (2010a). Validation of the Social Anxiety Questionnaire for Adults (SAQ-A30) with Spanish university students: Similarities and differences among degree subjects and regions. Behavioral Psychology/ Psicologia Conductual, 18, 5–34. Caballo, V. E., Salazar, I. C., Irurtia, M. J., Arias, B., Hofmann, S. G., & the CISO-A Research Team (2010b). Measuring social anxiety in 11 countries: Development and validation of the Social Anxiety Questionnaire for Adults. European Journal of Psychological Assessment, 26, 95–107. Caballo, V. E., Salazar, I. C., Irurtia, M. J., Arias, B., Hofmann, S. G. & CISO-A Research Team (2012). The multidimensional nature and multicultural validity of a new measure of social anxiety: the Social Anxiety Questionnaire for Adults. Behavior Therapy, 43, 313-328. Primary use / Purpose: The questionnaire is designed to measure specific and/or generalized social phobia/anxiety in adults (18 years and more) from general and clinical populations. This is very useful for identifying not only people with generalized social phobia but particularly specific social phobia. Background: The Social Anxiety Questionnaire for Adults (SAQ-A30) was a result of several years of work by the research team in 18 Latin American countries, Spain, and Portugal. It was developed from research with approximately 58,000 general participants and more than 1,000 social phobic patients. Regarding initial item selection, more than 1,000 participants recorded situations over 6 years, generating a pool of more than 10,000 social situations. From these, two pairs of social anxiety experts selected scenarios for initial analysis, excluding those situations that were redundant or were not social in nature (i.e., another person[s] played a role in the situation). This left 2,171 scenarios, which were then grouped together based on substantive similarity, leaving a total of 512 social situations. These situations composed the first version of the SAQ-A and after many statistical analyses and clinical judgments, the final version of the 30-item questionnaire was obtained (SAQ-A30). Psychometrics: The SAQ-A30 contains 30 items conforming a social phobia/anxiety structure of five very solid dimensions (factors), each of them including six items. Each dimension has its own cut-off score as the questionnaire also has as a whole. Data on the questionnaire's internal consistency, construct validity, cut-off scores, invariance, and factor structure have been presented (Caballo et al., 2010a, 2012). Other Information: Each item is answered on a 5-point Likert scale. The higher the score in every dimension the more anxiety the person has in this specific dimension. The sum of all the dimensions is the general score of the questionnaire. The five dimensions are the following: 1) Speaking in public/talking with people in authority, 2) Interactions with the opposite sex, 3) Assertive expression of annoyance, disgust, or displeasure, 4) Criticism and embarrassment, and 5) Interactions with strangers. The original questionnaire plus two control items and the cut-off scores for each factor and for the whole questionnaire are included in the reference below: Caballo, V. E., Salazar, I. C., Irurtia, M. J., Arias, B., Hofmann, S. G. & CISO-A Research Team (2012). The multidimensional nature and multicultural validity of a new measure of social anxiety: the Social Anxiety Questionnaire for Adults. Behavior Therapy, 43, 313-328. The original questionnaire without the control items is included in the following reference: Caballo, V. E., Salazar, I. C., Arias, B., Irurtia, M. J., Calderero, M., & the CISO-A Research Team Spain (2010a). Validation of the Social Anxiety Questionnaire for Adults (SAQ-A30) with Spanish university students: Similarities and differences among degree subjects and regions. Behavioral Psychology/ Psicologia Conductual, 18, 5–34. Initial development and validation of previous versions of the questionnaire can be found in the following reference: Caballo, V. E., Salazar, I. C., Irurtia, M. J., Arias, B., Hofmann, S. G., & the CISO-A Research Team (2010b). Measuring social anxiety in 11 countries: Development and validation of the Social Anxiety Questionnaire for Adults. European Journal of Psychological Assessment, 26, 95–107. P.D.: Although we have tried not to include situations related to the gender of people in the questionnaire, there are three items that include the term “opposite sex”. There was no way to substitute them. We suggest that for people whose sexual tendency is their same gender to substitute “opposite sex” for “preferred gender”. Copyright by Fundacion VECA. The questionnaire can be used for research and clinical purposes without further permission. However it can not be modified, used commercially or published by any means without prior permission from the first author (in the name of Fundacion VECA). Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.223

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

- 30/04/2020 - 1 Formular, 5 Itemgruppen, 62 Datenelemente, 1 Sprache
Itemgruppen: 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.

Kerndatensatz Herzinsuffizienz DZHI (Core data set heart failure CHFC) - Untersuchung Herzinsuffizienz (Examination heart failure)

- 24/03/2020 - 1 Formular, 5 Itemgruppen, 90 Datenelemente, 2 Sprachen
Itemgruppen: Logistics , Physical examination, ECG, 6MWT, Echocardiography
Core data set on heart failure, developed by the Comprehensive Heart Failure Center (CHFC). The CHFC researches and treats the complex disease heart failure and its comorbidities in a comprehensive approach. This form contains information about the examination of an heart failure Kerndatensatz zu Herzinsuffizienz, entwickelt vom Deutschen Zentrum für Herzinsuffizienz (DZHI). Das DZHI erforscht und therapiert in einem ganzheitlichen Ansatz die Systemerkrankung Herzinsuffizienz samt ihrer Begleit- und Folgeerkrankungen. Dieses Formular enthält Informationen über die Untersuchung einer Herzinsuffizienz.

DIVI Kerndatensatz Intensivmedizin 2010 - Entlassung von der Intensivtherapiestation

- 19/03/2020 - 5 Formulare, 2 Itemgruppen, 16 Datenelemente, 1 Sprache
Itemgruppen: DNR (do not resuscitate) / AND (allowed natural death), Procedures and complications
Kerndatensatz Intensivmedizin 2010 der DIVI und DGAI (nur patientenbezogene Daten, ohne Strukturdaten der Intensivtherapiestation und der Klinik ). Deutsche interdisziplinaere Vereinigung fuer Intensiv und Notfallmedizin DIVI (German interdisciplinary association for intensive and emergeny medical care), http://www.divi.de/images/Dokumente/Empfehlungen/Strukturempfehlungen/2010_KerndatensatzIntensivmedizin.pdf

Strukturdaten

1 Itemgruppe 28 Datenelemente

Aufnahmestatus

2 Itemgruppen 37 Datenelemente

Entlassung aus dem Krankenhaus

1 Itemgruppe 2 Datenelemente

Tägliche Datenerhebung

2 Itemgruppen 25 Datenelemente

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