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Table of contents
  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
  7. 7. Medical Specialty
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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

SF-36 (RAND)

- 9/17/21 - 1 form, 7 itemgroups, 36 items, 1 language
Itemgroups: General Info,Current health limitations,Physical Health related problems during past 4 weeks,Emotional problems during past 4 weeks,Past 4 weeks,Emotions in past 4 weeks,General statements
This document contains the 36-Item Short Form Survey Instrument Version 1 (SF-36) form, developed at RAND as part of the Medical Outcomes Study. RAND owns the copyright. All of the surveys and tools from RAND Health are public documents, available without charge. For more information - e.g. on terms and conditions for use or scoring instructions: https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form.html Changes made to the questionnaire should be made clearly identifiable.

Pancreatic Cancer NCT00058149 Quality of Life - Brief Pain Inventory - 2031356v3.0 - Brief Pain Inventory

- 1/9/15 - 1 form, 2 itemgroups, 23 items, 1 language
Itemgroups: Header,CCRR MODULE
Brief Pain Inventory A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AE65F8E1-704E-30A0-E034-0003BA12F5E7

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

DLQI - Dermatology Life Quality Index (DLQI)

- 9/7/16 - 1 form, 1 itemgroup, 12 items, 17 languages
Itemgroup: Skin problems past week
Details and Conditions of Use see: Finlay A.Y., Khan G.K. Dermatology Life Quality Index (DLQI) - A simple practical measure for routine clinical use. Clinical and Experimental Derm 1994; 19:210-16 Used as routine documentation at the University Hospital in Muenster (UKM).

German Myeloma Patient Outcome Scale (MyPOS) - MyPOS

- 3/15/22 - 1 form, 8 itemgroups, 40 items, 1 language
Itemgroups: Administratative Angaben,Symptome und Nebenwirkungen - Beeinträchtigung in der letzten Woche,Beeinträchtigung durch weitere Symptome,Verlauf der letzten Woche (Teil 1),Verlauf der letzten Woche (Teil 2),Probleme und Sorgen,Sorgen und Ängste,Ausfüllen des Fragebogens
Die Nutzung des MyPOS ist kostenfrei, es wird aber eine (kostenfreie) Registrierung auf der POS-Website (www.pos-pal.org) gewünscht. Um eine Information über Nutzung und/oder Änderung wird seitens des POS-Team explizit gebeten. Affiliation: Dr. med. Christina Gerlach M.Sc. Oberärztin | Klinik für Palliativmedizin Fachärztin für Innere Medizin, Hämatologie & Onkologie; Notfallmedizin, Palliativmedizin Universitätsklinikum Heidelberg | Im Neuenheimer Feld 305 | 69120 Heidelberg Tel. +49 6221 56-310683 | Fax. +49 6221 56-7203 | E-Mail: christina.gerlach@med.uni-heidelberg.de http://www.klinikum.uni-heidelberg.de Gerlach, C., Taylor, K., Ferner, M. et al. Challenges in the cultural adaptation of the German Myeloma Patient Outcome Scale (MyPOS): an outcome measure to support routine symptom assessment in myeloma care. BMC Cancer 20, 245 (2020). https://doi.org/10.1186/s12885-020-06730-7

Visit 24 (Week 240) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 2/18/22 - 1 form, 10 itemgroups, 41 items, 1 language
Itemgroups: Subject Identification,Vital Signs,Physical examination,EDSS Evaluation,Functional System Scores, EDSS,Additional and Results,Visual Function Test,Contrast Sensitivity Evaluation Binocular,Study Drug Accountability,Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 24 (Week 240)

Visit 20 (Week 192) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 2/17/22 - 1 form, 10 itemgroups, 42 items, 1 language
Itemgroups: Subject Identification,Vital Signs,Physical examination,EDSS Evaluation,Functional System Scores, EDSS,Additional and Results,Visual Function Test,Contrast Sensitivity Evaluation Binocular,Study Drug Accountability,Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 20 (Week 192)

KIORTH CPChild MS University Hospital Muenster (UKM)

- 11/17/21 - 1 form, 11 itemgroups, 159 items, 1 language
Itemgroups: General information,1. Personal care/ Activities of daily living,2. Positioning, Transferring & Mobility,3. Comfort & Emotions,4. Communication & Social Interaction,5. Health,6. Overall Quality of Life,7. Importance of items to your child's quality of life,8. Facts about your child,9. Facts about you,CPChild result
Hospital Routine Documentation Form at the University Hospital Muenster. Original Form name: KIORTH CPChild MS. German description: CPChild Ein Index zur gesundheitsbezogenen Lebensqualität bei Menschen mit Behinderung

Lung Cancer NCT00096265 Quality of Life - PQ RTOG Phase III Multiple Brain Metastases Fact Subscale - 2277326v3.0 - PQ RTOG Phase III Multiple Brain Metastases Fact Subscale

- 9/27/21 - 1 form, 3 itemgroups, 43 items, 1 language
Itemgroups: Header,Physical Well-Being,Additional Concerns
PQ RTOG Phase III Multiple Brain Metastases Fact Subscale Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D7FA7BFE-292F-6626-E034-0003BA12F5E7

Breast Cancer (NCT00053898) - Quality of Life Questionnaire Breast Cancer (NCT00053898)

- 9/20/21 - 1 form, 6 itemgroups, 70 items, 1 language
Itemgroups: Header,Symptom frequency,Problems past 4 weeks,Overall health,Mood,Sexual activity
Quality of Life Questionnaire Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy NCT00053898 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A0E240A0-FD2A-46A0-E034-080020C9C0E0

Colorectal cancer metastases (NCT00268463) - Quality of Life Form Colorectal Cancer (NSABP C-09 NCT00268463)

- 9/20/21 - 1 form, 8 itemgroups, 94 items, 1 language
Itemgroups: Header,Treatment satisfaction,PHYSICAL WELL-BEING,Social and family well being,EMOTIONAL WELL-BEING,Functional Health,ADDITIONAL CONCERNS,Activity
NSABP Protocol C-09: Quality of Life Form Oxaliplatin and Capecitabine With or Without an Hepatic Arterial Infusion With Floxuridine in Treating Patients Who Are Undergoing Surgery and/or Ablation for Liver Metastases Due to Colorectal Cancer NCT00268463 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FC7E0FCB-064A-58CD-E034-0003BA3F9857

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