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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
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185 Search results.

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Baseline II (General virological and laboratory findings for all phases)

- 12/4/20 - 1 form, 46 itemgroups, 320 items, 1 language
Itemgroups: Baseline: Types of virological testing, Baseline: PCR: Site of first detected SARS-CoV-2, Baseline: PCR: Tested target at first positive SARS-CoV-2 testing, Baseline: If pharyngeal swabs performed at SARS-CoV-2 testing: number of PCR cycles, Baseline: Anti-SARS-CoV-2 antibodies (IgG) titer measurement, Baseline: Anti-SARS-CoV-2 antibodies (IgA) titer measurement, Baseline: Laboratory values, Baseline: Hematological Values, Baseline: Other laboratory results, Baseline: Urine test strips, Uncomplicated phase: Types of virological testing, Uncomplicated phase: PCR: Sites of virological testing, Uncomplicated phase: If pharyngeal swabs performed at SARS-CoV-2 testing: number of PCR cycles, Uncomplicated phase: Viral coinfections, Uncomplicated phase: Anti-SARS-CoV-2 antibodies (IgG) titer measurement, Uncomplicated phase: Anti-SARS-CoV-2 antibodies (IgA) titer measurement, Uncomplicated phase: Laboratory values, Uncomplicated phase: Hematological Values, Uncomplicated phase: Other laboratory results, Complicated phase: Types of virological testing, Complicated phase: PCR: Sites of virological testing, Complicated phase: If pharyngeal swabs performed at SARS-CoV-2 testing: number of PCR cycles, Complicated phase: Viral coinfections, Complicated phase: Anti-SARS-CoV-2 antibodies (IgG) titer measurement, Complicated phase: Anti-SARS-CoV-2 antibodies (IgA) titer measurement, Complicated phase: Laboratory values, Complicated phase: Hematological Values, Complicated phase: Other laboratory results, Critical phase: Types of virological testing, Critical phase: PCR: Sites of virological testing, Critical phase: If pharyngeal swabs performed at SARS-CoV-2 testing: number of PCR cycles, Critical phase: Viral coinfections, Critical phase: Anti-SARS-CoV-2 antibodies (IgG) titer measurement, Critical phase: Anti-SARS-CoV-2 antibodies (IgA) titer measurement, Critical phase: Laboratory values, Critical phase: Hematological Values, Critical phase: Other laboratory results, Recovery phase: Types of virological testing, Recovery phase: PCR: Sites of virological testing, Recovery phase: If pharyngeal swabs performed at SARS-CoV-2 testing: number of PCR cycles, Recovery phase: Anti-SARS-CoV-2 antibodies (IgG) titer measurement, Recovery phase: Anti-SARS-CoV-2 antibodies (IgA) titer measurement, Recovery phase: Laboratory values, Recovery phase: Hematological Values, Recovery phase: Other laboratory results, Is data entry for this section finished?
Study Title: LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients https://leoss.net Study Indication: COVID-19 Date: 14.10.2020, 16:54 Published with permission by Prof. Dr. med. J.-J. Vehreschild. LEOSS is mandated by the ESCMID Emerging Infections Task Force (EITaF) and supported by the German Infectious Disease Society. It aims at a better understanding of the implications of the new virus on patients by systematically documenting patient data across Europe (Text adapted from leoss.net). For more information please visit the official website. This document is for baseline information and it contains the general virological and laboratory findings for all phases. It is closely related to Baseline I where further information is collected. Please keep in mind that the clinical phases represent time intervals while the baseline is a point in time. Data input of baseline and the clinical phase at diagnosis can but do not have to be identical. If a text field can't be filled out, note 'ND' (for not determined)

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Baseline I

- 11/27/20 - 1 form, 40 itemgroups, 251 items, 1 language
Itemgroups: Demography, Diagnosis information, days between infection and diagnosis, Disease phases at baseline and follow-up, Duration (days) of..., Follow-up duration after SARS-CoV-2 diagnosis, Last known status, Limitation of therapy during SARS-CoV-2 infection, Specialist palliative care during SARS-CoV-2 infection, Disease limiting life expectancy before positive SARS-CoV-2 testing, Comorbidities, Central nervous system / Neurological disesases, Comorbidities, Cardiovascular diseases, Comorbidities, Pulmonary diseases, Comorbidities, Hematological / oncological diseases, Comorbidities, Rheumatological diseases, Comorbidities, Allergology, Comorbidities, Other internal disorders, Comorbidities, Other conditions, Heart failure before SARS-CoV-2, NYHA classification, Body-Mass-Index (BMI), Smoking status, Use of e-cigarettes and / or vaporizer?, Treatments received, Recent immunosuppressive medication, Colonisation with multi-resistant pathogens, Complications at baseline: Thrombotic and thromboembolic manifestations, Complications at baseline: Neurological, Complications at baseline: Other severe organ damage, Complications at baseline: Other, Symptoms: Please click all symptoms which occurred in the respective clinical phase, Vital signs and respiratory parameters, Heart function: Ejection fraction (EF) at SARS-CoV-2 detection, Baseline: Chest CT results at SARS-CoV-2 detection, Cardiovascular magnetic resonance imaging (CMR) performed in any clinical phase, Neurological diagnostic in various phases, Complementary and/or integrative medicine (CIM) used in any phase, Agreement to share data for scientific purposes, Biomaterial availability for research proposes, Participation in interventional clinical trials
Study Title: LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients https://leoss.net Study Indication: COVID-19 Date: 14.10.2020, 16:54 Published with permission by Prof. Dr. med. J.-J. Vehreschild. LEOSS is mandated by the ESCMID Emerging Infections Task Force (EITaF) and supported by the German Infectious Disease Society. It aims at a better understanding of the implications of the new virus on patients by systematically documenting patient data across Europe (Text adapted from leoss.net). For more information please visit the official website. This document is for baseline information. A related document "Baseline II" documents further baseline information related to baseline timepoint and to disease periods. Baseline / diagnosis is defined as the day the sample of the first positive SARS-CoV-2 result was taken. Please note that only cases with known outcome are collected! If a text field can't be filled out, note 'ND' (for not determined).

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Demography Screen 2

- 6/7/20 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Demography, Geographic ancestry
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Vital Signs Screen 3

- 6/7/20 - 1 form, 1 itemgroup, 7 items, 1 language
Itemgroup: Measurement 1 (of 1)
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitus Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - 12-lead ECG Screen 4

- 6/7/20 - 1 form, 1 itemgroup, 9 items, 1 language
Itemgroup: Measurement 1 (of 1)
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

ICHOM Dementia - Index event and Baseline - Patient/Proxy-Reported Form

- 4/30/20 - 1 form, 12 itemgroups, 60 items, 1 language
Itemgroups: Administrative Data, Demographic factors, Associated clinical history, Outcome, Overall quality of life, Carer quality of life, Health-Related Quality of Life, Overall quality of wellbeing, Neuropsychiatric, Clinical Dementia Rating, Daily Living, Cognitive
ICHOM Dementia data collection Version 1.0.1 Revised: April 3rd, 2017 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 Dementia, the following conditions are covered by the Standard Set. Condition: Alzheimer’s disease | Vascular dementia | Dementia in other diseases classified elsewhere (e.g. dementia with Lewy bodies and fronto-temporal dementia) Stages: Early | Middle | Late This document contains the Index event and Baseline - Patient/Proxy-Reported Form. It has to be filled in at baseline index event, e.g. Memory Clinic Diagnosis. Collecting Clinician and Patient-Reported Outcome Measures: Neuropsychiatric Inventory (NPI). Copyrighted, fees only for industry-sponsored research. No republishing without permission of the originator (JL Cummings, 1994). Therefore (for now) only the total score will be included in this version of the standard set. Bristol Activity Daily Living Scale (BADLS). As redistribution possibility is not yet cleared, for now only the total score will be included in this version of the standard set. Quality of Life-AD (QOL-AD). Use of the scale in clinical practice or by academic users is free as long as no funding is received from commercial users, however a license is required. Therefore only the total score score will be included in this version of the standard set. Logsdon RG, Gibbons LE, McCurry SM, Teri L. Quality of Life in Alzheimer’s disease: Patient and Caregiver Reports. Journal of Mental Health and Aging. 1999;5(1):21-32 Quality of Wellbeing Scale-Self Administered (QWB-SA). The QWB-SA may be used free of charge by non-profit organizations that provide evidence of their non-profit status and agree to provide a copy of relevant, non-identifiable project data with UCSD; Scoring instructions are provided free of charge after a signed copyright agreement is received. As https://hoap.ucsd.edu/qwb-info/NotforProfit-Copyright.pdf is the official permission site, only the total score score will be included in this version of the standard set. EuroQol-5D (EQ-5D). As a license is required for use this questionaire, only the total score will be included in this version of the standard set. Veterans RAND 12 (VR-12). As this questionaire is copyrighted and needs an user agreement for use, only the total score score will be included in this version of the standard set. Clinical Dementia Rating (CDR). This questionaire is Copyrighted.The Washington University The Charles F. and Joanne Knight Alzheimer’s Disease Research Center (Knight ADRC) holds the United States Copyright for the Clinical Dementia Rating (CDR). Therefore only the total score score will be included in this version of the standard set. Montreal Cognitive Assessment (MoCA copyrighted). For clinical and educational use, MoCA© may be used, reproduced, and distributed without permission. For this Standard set ICHOM was supported by the Scottish Government. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Overactive bladder - Female Baseline Measures

- 4/30/20 - 1 form, 7 itemgroups, 31 items, 1 language
Itemgroups: Administrative Data, Demographics, Baseline clinical factors, Explanatory variable, OAB symptom severity and burden, Health Related Quality of Life, Sexual function
ICHOM Overactive bladder data collection Version 1.2.2 Revised: April 10th, 2017 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 Overactive Bladder, the following treatment approaches (or interventions) are covered by our Standard Set. Treatment Approaches : Patient education | Behavioral modification | Pharmacological management | Intradetrusor Botox, PTNS, SNS | Surgery This document contains the Female Baseline Measures form. It has to be filled in at Baseline. This document also should also be filled out repeatedly in the event of symptom recurrence. Collecting Clinician and Patient-Reported Outcome Measures: ICIQ-OAB, ICIQ-MLUTSsex and ICIQ-FLUTSsex. For all: Free for use in clinical practice, routine outcomes measurement, and clinical research. As permission from the developer is required, only the total score will be included in this version of the standard set. To obtain permission and an offical copy and scoring guide or to inquire about translations see http://www.iciq.net/userpolicy.html OAB-q SF (4-week recall). As a license is needed for use of this questionnaire, only the total score will be included in this version of the standard set. TBS. Free for use without a license. Please see Colman S et al (2008) Validation of the treatment benefit scale for assessing subjective outcomes in Treatment of Overactive Bladder. Urology 72:803-807 ICHOM's Standard set was supported by IUGA (international urogynecological association), National Association for Continence, The Canadian Continence Foundation, Continence Foundation of Australia Publication: Foust-Wright C, Wissig S, Stowell C, et al. Development of a core set of outcome measures for OAB treatment. Int Urogynecol J. 2017;28(12):1785–1793. doi:10.1007/s00192-017-3481-6 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Overactive bladder - Male Baseline Measures

- 4/30/20 - 1 form, 7 itemgroups, 30 items, 1 language
Itemgroups: Administrative Data, Demographics, Baseline clinical factors, Explanatory variable, OAB symptom severity and burden, Health Related Quality of Life, Sexual function
ICHOM Overactive bladder data collection Version 1.2.2 Revised: April 10th, 2017 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 Overactive Bladder, the following treatment approaches (or interventions) are covered by our Standard Set. Treatment Approaches : Patient education | Behavioral modification | Pharmacological management | Intradetrusor Botox, PTNS, SNS | Surgery This document contains the Male Baseline Measures form. It has to be filled in at Baseline. This document also should also be filled out repeatedly in the event of symptom recurrence. Collecting Clinician and Patient-Reported Outcome Measures: ICIQ-OAB, ICIQ-MLUTSsex and ICIQ-FLUTSsex. For all: Free for use in clinical practice, routine outcomes measurement, and clinical research. As permission from the developer is required, only the total score will be included in this version of the standard set. To obtain permission and an offical copy and scoring guide or to inquire about translations see http://www.iciq.net/userpolicy.html OAB-q SF (4-week recall). As a license is needed for use of this questionnaire, only the total score will be included in this version of the standard set. TBS. Free for use without a license. Please see Colman S et al (2008) Validation of the treatment benefit scale for assessing subjective outcomes in Treatment of Overactive Bladder. Urology 72:803-807 ICHOM's Standard set was supported by IUGA (international urogynecological association), National Association for Continence, The Canadian Continence Foundation, Continence Foundation of Australia Publication: Foust-Wright C, Wissig S, Stowell C, et al. Development of a core set of outcome measures for OAB treatment. Int Urogynecol J. 2017;28(12):1785–1793. doi:10.1007/s00192-017-3481-6 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Depression and Anxiety - Baseline - Patient-reported Form

- 4/30/20 - 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 Lung Cancer - Baseline - Clinical Form

- 4/30/20 - 1 form, 5 itemgroups, 14 items, 1 language
Itemgroups: Administrative data, Demographic factors, Baseline Clinical Factors, Baseline tumor factors, Degree of health
ICHOM Lung cancer data collection Version 2.3.1 Revised: April 10th, 2017 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 Lung Cancer, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Small Cell and Non-Small Cell Lung Cancer Treatment Approaches: Surgery | Radiotherapy | Chemotherapy | Targeted Therapy | Immunotherapy | Other This document contains Baseline - Clinical Form. It depicts first doctor's visit. Collecting Patient-Reported Outcome Measures: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire (EORTC QLQ-LC13). Both are free for all health care organizations, but a license is needed for use. http:// groups.eortc.be/qol/eortc-qlq-c30 is the official distribution site for EORTC QLQ-C30 and EORTC QLQ-LC13 questionnaire. Therefore only the total score will be included in this version of the standard set. Publication: Mak KS, van Bommel AC, Stowell C, et al. Defining a standard set of patient-centred outcomes for lung cancer. Eur Respir J. 2016;48(3):852–860. doi:10.1183/13993003.02049-2015 For this standard set ICHOM was supported by the Alliance of Dedicated Cancer Centers. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Hip and Knee Osteoarthritis - Baseline - Patient-reported

- 4/30/20 - 1 form, 9 itemgroups, 64 items, 1 language
Itemgroups: Administrative Data, Demographic factors, Case-mix factors, Treatment Variables, Functional status, Pain, Work Status, Quality of life, General treatment outcomes
ICHOM Hip and Knee Osteoarthritis Study description: ICHOM Hip and Knee Osteoarthritis data collection Version 2.2.1 Revised: April 10th, 2017 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 Hip and Knee Osteoarthritis, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions : All patients seeking treatment for osteoarthritis of the hip or knee, whether surgical or non-surgical Treatment Approaches: Non-Surgical: Lifestyle intervention | Patient education | Physiotherapy | Walking aid or orthosis | Topical and oral medication | Intra-articular injection Surgical: Osteotomy | Joint replacement | Other forms of surgical treatment This document contains the Baseline - Patient-reported form. Data collection may begin (baseline measure) at any point in a patient’s treatment for osteoarthritis whether at diagnosis of osteoarthritis in the hip or knee, upon the start of a new osteoarthritis treatment regime, or at the time of surgery. Once data collection begins, we recommend that it continues annually for as many years as feasible. Collecting Patient-Reported Outcome Measures: Hip Disability and Osteoarthritis Outcome Score - Physical Function Shortform (HOOS-PS). http://www.koos.nu/ Knee Injury and Osteoarthritis Outcome Score - Physical Function Shortform (KOOS-PS). http://www.koos.nu/ Veterans RAND 12 (VR-12) or Short Form 12 Health Survey (SF- 12). As a request for access and an agreement to terms of use are necessary before access, the actual questions of these questionnaires are not part of this version of the standard set. EuroQol-5D descriptive system (EQ- 5D-3L) and visual analogue scale (EQ-VAS). As a license is needed for use of EuroQol questionnaires, the actual questions are not part of this version of the standard set. *For a description of an algorithm to convert between the EQ-5D-3L and SF-12, please see: Le QA. Probabilistic mapping of the health status measure SF-12 responses and EQ-5D using the US-population-based scoring models. Qual Life Res. 2014 Mar; 23(2): 459-66. Please see the above Veterans RAND website for help converting the VR-12 to the SF-12. For this standard set ICHOM was supproted by Hoag Orthopedic Institute, the Connecticut Joint Replacement Institute, and Harvard Pilgrim Health Care and Arthritis Research. Publication: Rolfson O, Wissig S, van Maasakkers L, et al. Defining an International Standard Set of Outcome Measures for Patients With Hip or Knee Osteoarthritis: Consensus of the International Consortium for Health Outcomes Measurement Hip and Knee Osteoarthritis Working Group. Arthritis Care Res (Hoboken). 2016;68(11):1631–1639. doi:10.1002/acr.22868 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Hypertension in low- and middle-income countries - Baseline - Patient-reported

- 4/30/20 - 1 form, 4 itemgroups, 26 items, 1 language
Itemgroups: Administrative Data, Demographic factors, Clinical Factors, Patient-reported health status
ICHOM Hypertension in low- and middle-income countries data collection Version 1.0.0 Revised: November 3rd, 2017 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. The following condition and treatment approaches (or interventions) are covered by our Standard Set. Condition: Hypertension (ICD-10: I10) Treatment Approaches: Pharmacological and Non-Pharmacological Collecting Patient-Reported Outcome Measures: Survey Used: EuroQol-5D-3L (EQ-5D-3L). As a licence is needed for use of EQ-5D-3L questionnaires, the actual questions are not part of this version of the standard set. For licensing information see: https://euroqol.org/support/how-to-obtain-eq-5d/ This document contains the Baseline - Patient-reported form. It has to be filled in for patient's entry into study. PROMIS Single Question on erectile Dysfunction. Free for use in clinical practice. 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. Beliefs about Medication Questionnaire (BMQ)-Specific: Copyrighted, permission to use the scale can be obtained from Professor Rob Horne’s research team. The scoring guide can be found in the original validation article: Horne et al. (1999) The beliefs about medicines questionnaire: The development and evaluation of a new method for assessing the cognitive representation of medication. Psychology & Health, 14:1. Hill-Bone Compliance to High Blood Pressure Therapy Scale - South Africa Version: Permission to use the scale can be obtained from Estelle V. Lambert’s research team, The scoring guide can be found in the original validation article: Lambert, E.V. et al. (2006) Cross-Cultural Validation of the Hill-Bone Compliance To High Blood Pressure Therapy Scale in a South African, Primary Healthcare Setting. Ethnicity and Disease, 16. WHO STEPS Instrument. Free for use in clinical practice and a license is not required. http://www.who.int/chp/steps/instrument/en/ International Physical Activity Questionnaire(IPAQ)-Short Form: Publically available, open access, and no permissions are required to use it. https://sites.google.com/site/theipaq/ Alternative Quality of Life Surveys: PROMIS Global-10 Free for use in clinical practice. 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. Veteran’s Rand 12-Item Health Survey (VR-12). Free for all health care organizations, license required and can be requested at: http://bit.ly/2ir84sG. As a license is needed, the actual questions are not part of this version of the standard set. 12-Item Short Form Survey (SF-12). As a license is needed for use of SF-12 questionaires, the actual questions are not part of this version of the standard set. For more information see: http://bit.ly/2AcNLrme This Standard set was supported by the Novartis Foundation. Publication: Zack R, Okunade O, Olson E, et al. Improving Hypertension Outcome Measurement in Low- and Middle-Income Countries. Hypertension. 2019;73:990–997. doi: 10.1161/HYPERTENSIONAHA.118.11916 For this version of the standard set, semantic annotation with UMLS CUIs has been added.