Search results - Portal of Medical Data Models (MDM-Portal)

Itemgroups: Patient identification, Vital signs, 12 lead ECG, Holter Electrocardiography | Summary Report, Holter Electrocardiography | Electrocardiogram abnormal | Summary Report

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.

PATIENT HEALTH QUESTIONNAIRE-4 (PHQ-4)

- 9/20/21 - 1 form, 1 itemgroup, 4 items, 1 language

Itemgroup: Mood and anxiety symptoms past 2 weeks

In the mid-1990s, Robert L. Spitzer, MD, Janet B.W. Williams, DSW, and Kurt Kroenke, MD, and colleagues at Columbia University developed the Primary Care Evaluation of Mental Disorders (PRIME-MD), a diagnostic tool containing modules on 12 different mental health disorders. They worked in collaboration with researchers at the Regenstrief Institute at Indiana University and with the support of an educational grant from Pfizer Inc. During the development of PRIME-MD, Drs. Spitzer, Williams and Kroenke, created the PHQ, a self-administered version of the PRIME-MD. It contains the mood, anxiety, alcohol, eating, and somatoform modules as covered in the original PRIME-MD. The PHQ-4 consists of four items from the PHQ: two from the mood scale and two from the anxiety scale. ODM derived from http://www.phqscreeners.com/

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Pharmacogenetic Research, Prior And Concomitant Medication, Baseline Signs And Symptoms

- 9/20/21 - 1 form, 3 itemgroups, 28 items, 1 language

Itemgroups: Pharmacogenetic Research, prior medication, baseline signs and symptoms

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Pharmacogenetic Research, Prior And Concomitant Medication, Baseline Signs and Symptoms

Measurement Instrument Database for the Social Science (MIDSS) - Four-Dimensional Symptom Questionnaire (4DSQ)

- 8/12/20 - 1 form, 7 itemgroups, 50 items, 1 language

Itemgroups: Explanation, During THE PAST WEEK, did you suffer from:, During THE PAST WEEK, did you suffer from:, During THE PAST WEEK, did you feel:, During THE PAST WEEK, did you feel:, During THE PAST WEEK, did you:, During THE PAST WEEK:

Terluin, B.. (2012). Four-Dimensional Symptom Questionnaire (4DSQ) . Measurement Instrument Database for the Social Science. Retrieved 12.08.2020 from www.midss.ie Key references: Terluin B, Van Rhenen W, Schaufeli WB, De Haan M. The Four-Dimensional Symptom Questionnaire (4DSQ): measuring distress and other mental health problems in a working population. Work and Stress 2004; 18(3): 187-207. Terluin B, Van Marwijk HWJ, Adèr HJ, De Vet HCW, Penninx BWJH, Hermens MLM, Van Boeijen CA, Van Balkom AJLM, Van der Klink JJL, Stalman WAB. The Four-Dimensional Symptom Questionnaire (4DSQ): a validation study of a multidimensional self-report questionnaire to assess distress, depression, anxiety and somatization. BMC Psychiatry 2006; 6:34. Terluin B, Brouwers EPM, van Marwijk HWJ, Verhaak PFM, van der Horst HE. Detecting depressive and anxiety disorders in distressed patients in primary care; comparative diagnostic accuracy of the Four-Dimensional Symptom Questionnaire (4DSQ) and the Hospital Anxiety and Depression Scale (HADS). BMC Fam Pract 2009; 10:58. Primary use / Purpose: The 4DSQ is a self-report questionnaire to assess distress, depression, anxiety and somatization. It is mainly used in primary care. The 4DSQ helps to differentiate between normal distress and psychiatric disorder. Background: Many health care problems in primary care are stress-related (distress) and do not represent true psychiatric disorder (irrespective of whether DSM-IV criteria for depressive or anxiety disorders are fulfilled). Indiscriminate application of DSM-IV criteria in the primary care setting produces many false positive diagnoses confusing patients and misleading professionals. In health care practice the 4DSQ can be used to: - help patients acknowledge mental health issues when presenting with physical complaints, - assess the overall severity of the mental health problems, - detect depressive and anxiety disorders severe enough to require specific treatment (antidepressants or cognitive behavioral therapy), - monitor patients' progress under treatment. Psychometrics: The 4DSQ has been extensively tested for reliability and validity. Reliability is high (coefficients generally >.80). Factorial, critirion and concurrant validity has been confirmed. Web link to tool: Four-Dimensional Symptom Questionnaire (4DSQ) Other Information: The 4DSQ is free for non-commercial use. Available language versions: English, Dutch, French, German, Polish, Turkish Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.167 Scoring: "no" = score 0 "sometimes" = score 1 "regularly" or more often = score 2 Distress: sum the items 17, 19, 20, 22, 25, 26, 29, 31, 32, 36, 37, 38, 39, 41, 47, 48 Interpretation: moderately elevated if > 10, strongly elevated if > 20 Depression: sum the items 28, 30, 33, 34, 35, 46 Interpretation: moderately elevated if > 2, strongly elevated if > 5 Anxiety: sum the items 18, 21, 23, 24, 27, 40, 42, 43, 44, 45, 49, 50 moderately elevated if > 8, strongly elevated if > 12 Somatisation: sum the items 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 moderately elevated if > 10, strongly elevated if > 20

Measurement Instrument Database for the Social Science (MIDSS) - The Penn State Worry Questionnaire (PSWQ)

- 8/5/20 - 1 form, 2 itemgroups, 18 items, 1 language

Itemgroups: General Information, The Penn State Worry Questionnaire (PSWQ)

Meyer, T. J., Miller, M. L., Metzger, R. L., Borkovec, T. D. (1990). The Penn State Worry Questionnaire (PSWQ). Measurement Instrument Database for the Social Science. Retrieved 05.08.2020, from www.midss.ie Key references: Original article: Meyer, T. J., Miller, M. L., Metzger, R. L., & Borkovec, T. D. (1990). Development and validation of the penn state worry questionnaire. Behavior Research and Therapy, 28, 487-495. Brown, T.A. Confirmatory factor analysis of the Penn State Worry Questionnaire: Multiple factors or method effects? Behavior Research and Therapy (2003) 41, 1411-14226. Fresco, D.M., et. al. ( 2003) Using the Penn State Worry Questionnaire to identify individuals with Generalized Anxiety Disorder: a receiver operating characteristic analysis. Journal of Behavior Therapy and Experimental Psychiatry. 34, 283-291. Gillis, M.M., Haaga, D.A. and Ford, G.T. (1995) Normative values for the Beck Anxiety Inventory, Fear Questionnaire, Penn State Worry Questionnaire, and Social Phobia and Anxiety Inventory. Psychological Assessment, 7, 450-455. Primary use / Purpose: The Penn State Worry Questionnaire (PSWQ) is a 16-item questionnaire that aims to measure the trait of worry, using Likert rating from 1 (not at all typical of me) to 5 (very typical of me). Research suggests that the instrument has a strong ability to differentiate patients with generalized anxiety disorder (GAD) from other anxiety disorders. Background: Worry is regarded as a dominant feature of GAD. Since its development in 1990, the PSWQ has become a widely used self-report tool for pathological worry and GAD. The PSWQ attempts to measure the excessiveness, generality, and uncontrollable dimensions of worry. Psychometrics: The PSWQ has shown to possess high internal consistency and good test-retest reliability (Meyer et al., 1990). Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.158 Scoring the PSWQ In scoring the PSWQ, a value of 1, 2, 3, 4, and 5 is assigned to a response depending upon whether the item is worded positively or negatively. The total score of the scale ranges from 16 to 80. Items 1, 3, 8, 10, 11 are reverse scored as follows: • Very typical of me = 1 (circled 5 on the sheet) • Circled 4 on the sheet = 2 • Circled 3 on the sheet = 3 • Circled 2 on the sheet = 4 • Not at all typical of me = 5 (circled 1 on the sheet) For items 2, 4, 5, 6, 7, 9, 12, 13, 14, 15, 16 the scoring is: • Not at all typical of me = 1 • Ratings of 2, 3, and 4 are not transformed • Very typical of me = 5

Measurement Instrument Database for the Social Science (MIDSS) - Anxiety Disorder Diagnostic Questionnaire (ADDQ)

- 7/31/20 - 1 form, 5 itemgroups, 27 items, 1 language

Itemgroups: Information, 1., 2., 3., 4.

Norton & Robinson. (2012). Anxiety Disorder Diagnostic Questionnaire (ADDQ). Measurement Instrument Database for the Social Science. Retrieved 31.07.2020 from www.midss.ie Key references: Norton, P. J., & Robinson, C. M. (2010). Development and evaluation of the anxiety disorder diagnostic questionnaire. Cognitive Behaviour Therapy, 39, 137-149. Primary use / Purpose: The ADDQ is a 4-part self-report questionnaire assessing fearfulness and apprehension/worry, the severity, interference, and distress of the anxiety, as well as specific symptoms (i.e. shortness of breath, irritability). Background: The ADDQ was constructed as a screening tool for the presence of clinical fear and anxiety independent of diagnoses, in both clinical and nonclinical populations. Psychometrics: Support for the psychometric validity of the ADDQ is presented (Norton & Robinson, 2010). Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.154

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Table of contents

Selected data models

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

Gesundheitsfragebogen für Patienten (GAD-2) - F.1

dbGaP phs000979 HBCC Postmortem Psychiatric Molecular Studies - pht005195.v2.p2

Eligibility

pht005196.v3.p2

pht005193.v2.p2

pht005194.v3.p2

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

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

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