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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
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WHO-5 - WHO (Five) Well-Being Index

- 9/9/21 - 1 form, 1 itemgroup, 5 items, 30 languages
Itemgroup: Over the last two weeks
WHO (Five) Well-Being Index (1998 version) http://www.who-5.org Also called : WHO Five, WHO 5

HADS - Hospital Anxiety and Depression Scale (HADS)

- 11/16/18 - 1 form, 1 itemgroup, 14 items, 1 language
Itemgroup: In the past week
Hospital Anxiety and Depression Scale (HADS) was originally developed by [Zigmond, AS; Snaith, RP (1983). "The hospital anxiety and depression scale". Acta Psychiatrica Scandinavica 67 (6): 361–370] and is commonly used by doctors to determine the levels of anxiety and depression that a patient is experiencing. Also used for routine documentation at the University Hospital Muenster (UKM) see http://en.wikipedia.org/wiki/Hospital_Anxiety_and_Depression_Scale

DASS Depressions-Angst-Stress-Skalen – deutschsprachige Kurzfassung - DASS

- 12/28/21 - 1 form, 1 itemgroup, 21 items, 1 language
Itemgroup: Fragen zum Befinden
Die deutschsprachige Kurzfassung der Depressions-Angst-Stress-Skalen (DASS) wird in der Schmerzforschung und -behandlung verwendet und wurde entwickelt, um psychologische Kernaspekte von Depression, Angst und Stress zu erfassen. Sie umfasst drei Skalen mit jeweils sieben Items. Die Erfassung psychischer Belastung hat einen zentralen Stellenwert in der Schmerzforschung und -behandlung. Für Depression als Komorbidität bei Schmerz bestehen dabei besondere methodische und konzeptionelle Schwierigkeiten. Reliabilität: Cronbachs Alpha lag bei Alpha = .91 (Depression), Alpha = .78-.82 (Angst) bzw. Alpha = .81-.89 (Stress). Validität: Konstruktvalidität des DASS wurden mit HADS (Hospital Anxiety and Depression Scale) und ADS (Allgemeine Depressionsskala) verglichen. Spezifität und Sensitivität für Depression wurden anhand eines strukturierten klinischen Interviews für DSM-IV (SKID) ermittelt und ebenfalls mit ADS und HADS verglichen. Nilges, P. & Essau, C. (2021). DASS. Depressions-Angst-Stress-Skalen - deutschsprachige Kurzfassung [Verfahrensdokumentation und Fragebogen mit Auswertung]. In Leibniz-Institut für Psychologie (ZPID) (Hrsg.), Open Test Archive. Trier: ZPID. https://doi.org/10.23668/psycharchives.4579 Disclaimer: After completion of my work with the measure, I will inform the test authors about the use of the measure and the results I have obtained by means of the feedback form.

Center for Epidemiologic Studies Depression Scale – Revised (CESD-R)

- 9/27/21 - 1 form, 1 itemgroup, 20 items, 1 language
Itemgroup: Symptoms of depression past week
The Center for Epidemiologic Studies Depression Scale (CESD) was created in 1977 by Laurie Radloff, and revised in 2004 by William Eaton and others. The 20 items in CESD-R scale measure symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition. References: Eaton WW, Muntaner C, Smith C, Tien A, Ybarra M. Center for Epidemiologic Studies Depression Scale: Review and revision (CESD and CESD-R). In: Maruish ME, ed. The Use of Psychological Testing for Treatment Planning and Outcomes Assessment. 3rd ed. Mahwah, NJ: Lawrence Erlbaum; 2004:363-377. Radloff LS. The CES-D scale: a self-report depression scale for research in the general population. Applied Psychological Measurement. 1977;1:385-401. http://cesd-r.com/

Depression - Adult PhenX Toolkit

- 9/27/21 - 1 form, 1 itemgroup, 36 items, 2 languages
Itemgroup: PhenX - depression - adult protocol
This protocol is divided into two parts. Part I consists of the depression section from the Composite International Diagnostic Interview - Short Form (CIDI-SF), developed for the World Health Organization, and is a screening tool for the general population. Part II consists of the Quick Inventory of Depressive Symptoms (QIDS) that captures the severity of depressive symptoms in the last seven days. ODM derived from: https://cde.nlm.nih.gov Primary source: https://www.phenxtoolkit.org/ Recent publication: Hendershot, T., Pan, H., Haines, J., Harlan, W.R., Marazita, M.L., McCarty, C.A., Ramos, E.M., and Hamilton, C.M. (2015) Using the PhenX toolkit to add standard measures to a study. Curr. Protoc. Hum. Genet. 86:1.21.1-1.21.17. doi: 10.1002/0471142905.hg0121s86 German translation of CIDI-SF not validated. German translation of QIDS: http://www.ids-qids.org/translations/german/QIDS-SR_AU1.0_ger-DE.pdf Permission to publish granted by Carol M. Hamilton.

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Logs and Repeats and Concomitant Medications

- 9/20/21 - 1 form, 3 itemgroups, 23 items, 1 language
Itemgroups: Date of visit/ assessment,Adverse event | Concomitant Medication Ongoing | Evaluation,Pharmaceutical Preparations Concomitant Therapy
Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram Study Indication: Depressive Disorder and Anxiety Disorders

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Repeat Local laboratory, urinalysis, vital signs, ECG and Pharmacokinetics

- 9/20/21 - 1 form, 8 itemgroups, 58 items, 1 language
Itemgroups: Local Laboratory,Urinalysis | Local,Vital signs,12 lead ECG,Electrocardiogram abnormal,Drug Kinetics; Blood,12 lead ECG | Holter Electrocardiography | Summary Report,Holter Electrocardiography | Electrocardiogram abnormal | Summary Report
Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Vital Signs and ECG - Screening

- 9/20/21 - 1 form, 5 itemgroups, 28 items, 1 language
Itemgroups: Patient identification,Vital signs,12 lead ECG,Holter Electrocardiography | Summary Report,Holter Electrocardiography | Electrocardiogram abnormal | Summary Report
Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram Study Indication: Depressive Disorder and Anxiety Disorders

ICHOM Depression and Anxiety - Baseline - Patient-reported Form

- 9/20/21 - 1 form, 8 itemgroups, 70 items, 1 language
Itemgroups: Administrative Data,Demographic factors,Health status,Prior Treatment,Symptom Burden,Functioning,Recovery Speed and Health Sustainability,Other
ICHOM Depression and Anxiety data collection Version 2.3.2 Revised: August 10th, 2018 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://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. For Depression and Anxiety, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. This document contains the Baseline - Patient-reported Form. It has to be filled in at Baseline(Treatment begin). Condition: Depression: Major Depressive Disorder | Dysthymia | Depressive Adaptive/Adjustment Disorder | Depressive Disorder - NOS Anxiety: Generalized Anxiety Disorder | Phobic Disorder | Agoraphobia | Post-Traumatic Stress Disorder | Panic Disorder | Obsessive-Compulsive Disorder Treatment Approaches : Psychopharmacotherapy | Psychotherapy | Lifestyle Interventions | Self-Guided Help | Other Forms of Therapy Collecting Clinician and Patient-Reported Outcome Measures: PHQ-9 (Patient Health Questionnaire). https://www.phqscreeners.com/ Pfizer: All PHQ, GAD-7 screeners and translations are downloadable from this website and no permission is required to reproduce, translate, display or distribute them. GAD-7 (Generalized Anxiety Disorder). https://www.phqscreeners.com/ Pfizer: All PHQ, GAD-7 screeners and translations are downloadable from this website and no permission is required to reproduce, translate, display or distribute them. (and all other GAD or PHQ screeners); Pfizer owner, authors: Drs. Spitzer, Williams and Kroenke SPIN (Social Phobia Inventory ), MIA (Mobility Inventory for Agoraphobia), IES-R (Impact of Event Scale - Revised for Post-traumatic Stress Disorder), PDSS-SR (Panic Disorder Severity Scale), OCI-R (Obsessive-Compulsive Inventory). As permission for use has to be obtained for all of these questionnaires from the copyright holder, only the total score will be included in this version of the standard set. WHODAS 2.0 (World Health Organization Disability Assessment Schedule 2.0). As there is a license needed for use of this questionnaire, only the total score will be included in this version oft he standard set. MOS-SSS (Medical Outcomes Study: Social Support Survey). There is no license or permission needed for use. https://www.rand.org/health-care/surveys_tools/mos/social-support.html This Standard set of ICHOM was supported by the Douglas mental health university institute, Charité Universitätsmedizin Berlin, Stichting benchmark GGC. Publication: Obbarius A, van Maasakkers L, Baer L, et al. Standardization of health outcomes assessment for depression and anxiety: recommendations from the ICHOM Depression and Anxiety Working Group. Qual Life Res. 2017;26(12):3211–3225. doi:10.1007/s11136-017-1659-5 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Depression and Anxiety - Annual Patient-Reported Form

- 9/20/21 - 1 form, 8 itemgroups, 69 items, 1 language
Itemgroups: Administrative Data,Demographic factors,Health status,Prior Treatment,Symptom Burden,Functioning,Recovery Speed and Health Sustainability,Other
ICHOM Depression and Anxiety data collection Version 2.3.2 Revised: August 10th, 2018 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://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. For Depression and Anxiety, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. This document contains the Annual Patient-Reported Form. It has to be filled in annually. After the first year there is a more comprehensive annual evaluation. Condition: Depression: Major Depressive Disorder | Dysthymia | Depressive Adaptive/Adjustment Disorder | Depressive Disorder - NOS Anxiety: Generalized Anxiety Disorder | Phobic Disorder | Agoraphobia | Post-Traumatic Stress Disorder | Panic Disorder | Obsessive-Compulsive Disorder Treatment Approaches : Psychopharmacotherapy | Psychotherapy | Lifestyle Interventions | Self-Guided Help | Other Forms of Therapy Collecting Clinician and Patient-Reported Outcome Measures: PHQ-9 (Patient Health Questionnaire). https://www.phqscreeners.com/ Pfizer: All PHQ, GAD-7 screeners and translations are downloadable from this website and no permission is required to reproduce, translate, display or distribute them. GAD-7 (Generalized Anxiety Disorder). https://www.phqscreeners.com/ Pfizer: All PHQ, GAD-7 screeners and translations are downloadable from this website and no permission is required to reproduce, translate, display or distribute them. Pfizer owner, authors: Drs. Spitzer, Williams and Kroenke SPIN (Social Phobia Inventory ), MIA (Mobility Inventory for Agoraphobia), IES-R (Impact of Event Scale - Revised for Post-traumatic Stress Disorder), PDSS-SR (Panic Disorder Severity Scale), OCI-R (Obsessive-Compulsive Inventory). As permission for use has to be obtained for all of these questionnaires from the copyright holder, only the total score will be included in this version of the standard set. WHODAS 2.0 (World Health Organization Disability Assessment Schedule 2.0). As there is a license needed for use of this questionnaire, only the total score will be included in this version oft he standard set. MOS-SSS (Medical Outcomes Study: Social Support Survey). There is no license or permission needed for use. https://www.rand.org/health-care/surveys_tools/mos/social-support.html ICHOM's Standard set was supported by the Douglas Institut universitaire en santé mentale and mental health university institute, Charité Universitätsmedizin Berlin, Stichting benchmark GGC. Publication: Obbarius A, van Maasakkers L, Baer L, et al. Standardization of health outcomes assessment for depression and anxiety: recommendations from the ICHOM Depression and Anxiety Working Group. Qual Life Res. 2017;26(12):3211–3225. doi:10.1007/s11136-017-1659-5 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Depression and Anxiety - Ongoing - Patient-Reported Form

- 9/20/21 - 1 form, 5 itemgroups, 40 items, 1 language
Itemgroups: Administrative Data,Prior Treatment,Treatment Variables,Symptom Burden,Other
ICHOM Depression and Anxiety data collection Version 2.3.2 Revised: August 10th, 2018 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://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. For Depression and Anxiety, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. This document contains the Ongoing - Patient-Reported Form. It has to be filled in between Baseline and Annually form. The ongoing periode includes e.g.: Active treatment stage; Measure essential PROs ongoing with treatment (potentially at every visit) Condition: Depression: Major Depressive Disorder | Dysthymia | Depressive Adaptive/Adjustment Disorder | Depressive Disorder - NOS Anxiety: Generalized Anxiety Disorder | Phobic Disorder | Agoraphobia | Post-Traumatic Stress Disorder | Panic Disorder | Obsessive-Compulsive Disorder Treatment Approaches : Psychopharmacotherapy | Psychotherapy | Lifestyle Interventions | Self-Guided Help | Other Forms of Therapy Collecting Clinician and Patient-Reported Outcome Measures: PHQ-9 (Patient Health Questionnaire). https://www.phqscreeners.com/ Pfizer: All PHQ, GAD-7 screeners and translations are downloadable from this website and no permission is required to reproduce, translate, display or distribute them. GAD-7 (Generalized Anxiety Disorder). https://www.phqscreeners.com/ Pfizer: All PHQ, GAD-7 screeners and translations are downloadable from this website and no permission is required to reproduce, translate, display or distribute them. Pfizer owner, authors: Drs. Spitzer, Williams and Kroenke SPIN (Social Phobia Inventory ), MIA (Mobility Inventory for Agoraphobia), IES-R (Impact of Event Scale - Revised for Post-traumatic Stress Disorder), PDSS-SR (Panic Disorder Severity Scale), OCI-R (Obsessive-Compulsive Inventory). As permission for use has to be obtained for all of these questionnaires from the copyright holder, only the total score will be included in this version of the standard set. WHODAS 2.0 (World Health Organization Disability Assessment Schedule 2.0). As there is a license needed for use of this questionnaire, only the total score will be included in this version oft he standard set. MOS-SSS (Medical Outcomes Study: Social Support Survey). There is no license or permission needed for use. https://www.rand.org/health-care/surveys_tools/mos/social-support.html ICHOM's Standard set was supported by the Douglas Institut universitaire en santé mentale and mental health university institute, Charité Universitätsmedizin Berlin, Stichting benchmark GGC. Publication: Obbarius A, van Maasakkers L, Baer L, et al. Standardization of health outcomes assessment for depression and anxiety: recommendations from the ICHOM Depression and Anxiety Working Group. Qual Life Res. 2017;26(12):3211–3225. doi:10.1007/s11136-017-1659-5 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Eligibility Atypical Depression NCT00215176

- 9/20/21 - 1 form, 2 itemgroups, 16 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Modafinil for Atypical Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00215176

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