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  1. 1. Clinical Trial
  2. 2. Routine Documentation
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  6. 6. Patient-Reported Outcome
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Ersterhebung_Vor_Begleiterkrankungen CRF AML2003 AML - Ersterhebung_Vor_Begleiterkrankungen

- 9/27/21 - 1 form, 3 itemgroups, 17 items, 2 languages
Itemgroups: Allgemeine Angaben,Vor- und Begleiterkrankungen,Unterschrift
Prospektive, randomisierte, multizentrische Therapie optimierungsstudie - Studienprotokoll AML2003 http://clinicaltrials.gov/show/NCT00180102

Baseline Visite (Visite 2/ Woche 0) TMP001 Multiple Sclerosis NCT02686788 - Baseline Visite (Visite 2/ Woche 0)

- 9/27/21 - 1 form, 10 itemgroups, 53 items, 1 language
Itemgroups: Administrative documentation,Vital signs; Body Temperature,Comorbidity; Exacerbation of multiple sclerosis,Physical examination,Urinalysis,Inclusion criteria; exclusion criteria,Laboratory,Blood sampling,Kurtzke Expanded Disability Status Scale Questionnaire,study drug
Study part: Baseline Visite (Visite 2/ Woche 0). TMP001 in Relapsing-remitting Multiple Sclerosis: A Multicentre Open, Baseline-controlled Phase IIa Clinical Trial.

ICHOM Congenital Upper Limb Anomalies - On referral - Clinical Form

- 9/20/21 - 1 form, 5 itemgroups, 89 items, 1 language
Itemgroups: Administrative Data,Patient Demographic Factors,Family Demographic Factors,Clinical status,OMT Classification
ICHOM Congenital Upper Limb Anomalies data collection Version 1.0.0 August 31st, 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 Congenital Upper Limb Anomalies, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Congenital Hand Anomaly | Congenital Upper Limb Anomaly | Apert | Cleft Hand | Constriction Ring | Polydactyly | Radial Ray Deficiency | Symbrachydactyly | Thumb Hypoplasia | Ulnar Dysplasia | Ulnar Ray Deficiency Treatment approaches: Surgery | Rehabilitation | Other This document contains the On referral - Clinical Form. It has to be filled in at Patient's entry into the set. Collecting Patient-Reported Outcome Measures: Joint Mobility Questions. There are no licensing requirements to use these questions. PROMIS Upper Extremity, Global Health, Peer relationships, Anxiety, Depression. As there is an official distribution site, these questionnaires will not be included in this version of the standard set. For more information see: http://www.healthmeasures.net/exploremeasurement-systems/promis/obtain-administer-measures Goniometry, Dynamometry for Clinician. Follow the clinical assessment recommendations of the American Dynamometry - Clinician Society of Hand Therapists. Manual Muscle Strength Testing – Clinician. Use the Medical Research Council MMST grading. Oberg-Manske-Tonkin Classification. For more information see: Oberg KC, Feenstra JM, Manske PR, et al. Developmental biology and classification of congenital anomalies of the hand and upper extremity. J Hand Surg Am. 2010;35:2066. The Standard set of ICHOM was supported by the Great Ormond Stres Hospital, the Boston Children’s Hospital, the Erasmus MC, the Royal North Shore Hospital, the Texas Scottish Rite Hospital and the Loma Linda University. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Breast Cancer - Baseline - Patient-reported

- 9/20/21 - 1 form, 4 itemgroups, 29 items, 1 language
Itemgroups: Administrative Data,Demographic factors,Baseline clinical factors,Degree of health
ICHOM Breast Cancer data collection Version 1.0.1 Revised: March 30, 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 Breast Cancer, the following treatment approaches (or interventions) are covered by our Standard Set. Conditions*: All patients (men and women) with newly pathologically diagnosed invasive breast cancer (stage I-IV) and ductal carcinoma in situ (DCIS). *Excluded Conditions: Rare tumors (e.g. phyllodes tumor), lobular carcinoma in situ (LCIS) and patients with recurrent disease at baseline will be excluded. Treatment approaches: (Reconstructive) Surgery | Radiotherapy | Chemotherapy | Hormonal Therapy | Targeted Therapy | This document contains the Baseline - Patient-reported form. It has to be filled in before first doctor's visit. Collecting Patient-Reported Outcome Measures: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, EORTC QLQ-BR23, EORTC QLQ-LMC21). As a permission is needed for use of these questionnaires, only the total score of each will be included in this version of the standard set. More information can be found at http://groups.eortc.be/qol/eortc-qlq-c30 BREAST-Q Patient Reported Outcomes Instrument (BREAST-Q). As a license is needed for use of this questionnaire, only the total score will be included in this version of the standard set. For more information, please visit: https:// eprovide.mapi-trust.org/instruments/ breast-q#contact_and_conditions_of_ use Functional Assessment of Cancer Therapy Endocrine Subscale (FACT-ES). As a permission is needed for use of this questionnaire, only the total score of each will be included in this version of the standard set. For more information see http://www.facit.org/facitorg/ questionnaires. Reference: Ong WL, Schouwenburg MG, van Bommel AC, et al. A Standard Set of Value-Based Patient-Centered Outcomes for Breast Cancer: The International Consortium for Health Outcomes Measurement (ICHOM) Initiative. JAMA Oncol. 2017;3(5):677–685. doi:10.1001/jamaoncol.2016.4851 The Standard set of ICHOM was supported by the Dutch Dnstitute for Clinical Auditing, Onderlinge Waarborgmaatschappij Centrale Zorgverzekeraars group, Ramsay Health Care and Karolinska Institute. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Cleft Lip and Palate - Baseline - Clinical Form

- 9/20/21 - 1 form, 3 itemgroups, 24 items, 1 language
Itemgroups: Administrative Data,Demographic factors,Baseline Clinical Status
ICHOM Cleft Lip and Palate data collection Version 3.0.6 Revised: March 20th, 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 Cleft Lip and Palate, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Cleft Lip | Cleft Palate | Cleft Lip and Alveolus | Cleft Lip and Palate | Robin Sequence | 22q11 | CL&P Associated with Other Craniofacial Abnormalities | CL&P Associated with Other Congenital Abnormalities Treatment approaches: Audiology | Otology | Speech/Communication | Feeding/Nutrition | Plastic Surgery | Oral & Maxillofacial Surgery | Dentistry | Orthodontics | Pediatrics | Nursing | Genetics | Social Work | Psychology/Psychiatry This document contains the Baseline - Clinical Form. It has to be filled in at index event (first doctor’s visit). Collecting Patient-Reported Outcome Measure: CLEFT-Q. As there is no permission for publication of this questionnaire on this portal, only the total score will be included in this version of the standard set. Nasal Obstruction NOSE Scale-Patient . The study for development and validation of the NOSE Scale was funded by the AAO-HNS/F. If others wish to use the tool, there is no cost, but the study should be referenced: Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg 2004;130:157-63. COHIP Oral Symptoms Scale-Patient. The COHIP is free for all health care organizations, and a license is not needed according to ICHOM. Broder HL, McGrath C, Cisneros GJ. Questionnaire development: Face validity and item impact testing of the child oral health impact profile Community Dent Oral Epidemiol 2007; 35 Suppl 1:8-19. Intelligibility in Context Scale (ICS)-Parent. The ICS is free for all health care organizations, and a license is not needed (according to ICHOM). McLeod, S., Harrison, L. J., & McCormack, J. (2012). Intelligibility in Context Scale. Bathurst, NSW, Australia: Charles Sturt University. Available at http://www.csu.edu.au/research/multilingual-speech/ics under CC 3.0 by-nc-nd. PCC-Clinician. The PCC is free for all health care organizations, and a license is not needed. Reference: Allori, A. C., Kelley, T., Meara, J. G., Albert, A., Bonanthaya, K., Chapman, K., … Wong, K. W. (2017). A Standard Set of Outcome Measures for the Comprehensive Appraisal of Cleft Care. The Cleft Palate-Craniofacial Journal, 54(5), 540–554 The Standard set of ICHOM was supported by the Boston Children’s Hospital, The Children’s Hospital of Philadelphia. Texas Children’s Hospital and the Great Ormond Street Hospital. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

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.

Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636 - Subject at Home Diary - Baseline

- 9/20/21 - 1 form, 6 itemgroups, 27 items, 1 language
Itemgroups: Administrative documentation,Blood Pressure, Exercise, Information,Pharmaceutical Preparations, Subject Diary,Alcohol consumption, Subject Diary,Caffeine Use, Subject Diary,Tobacco Use, Subject Diary
Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194) - Baseline

- 9/20/21 - 1 form, 8 itemgroups, 32 items, 1 language
Itemgroups: Administrative documentation,Eligibility Determination,Vital signs,Concomitant Agent,Medical procedure,Signs and Symptoms,Employment status, Baseline,Randomization, Dispensing medication
Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Visit 1 - Baseline Form Clinical Trial on the Efficacy and Safety BID Mometasone Furoate Nasal Spray (MFNS) in the Treatment of Chronic Sinusitis - Visit 1 - Baseline Form

- 9/20/21 - 1 form, 9 itemgroups, 56 items, 1 language
Itemgroups: Header module,Patient demographics,Inclusion criteria,Footer module,Exclusion criteria,Physical Examination,Medication,Laboratory,Rhinosinusitis Disability Index (RSBI)
This study evaluates the effectiveness and safety of MFNS in improving the Treatment of Chronic Sinusitis. ODM derived from:"Randomized Double-blind Clinical Trial on the Efficacy and Safety of 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) or Placebo in the Treatment of Chronic Sinusitis". Leader of the clinical trial: Prof. Dr. med. Karl Hörmann Direktor der Hals-Nasen-Ohren-Klinik / Clinic Director Ear, Nose and Throat Clinic Medical Faculty Mannheim Heidelberg University at the University Medical Centre Mannheim Theodor-Kutzer-Ufer 1-3 68167 Mannheim

ICHOM Older Person - Baseline - Clinician- and Administrative-reported

- 9/20/21 - 1 form, 8 itemgroups, 33 items, 1 language
Itemgroups: Administrative Data,Demographic factors,Disutility of care,Symptoms, functioning and quality of life,Frailty,Time spent in hospital,Overall survival,Place of death
ICHOM Older Person data collection Version 1.0.4 Revised: July 12, 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 Older Persons, the following treatment approaches are covered by our Standard Set. Treatment approaches: These have not been defined due to the wide range of management options and interventions for an older population. A number of potentially inappropriate medications have been listed as ‘medication variables’. This document contains the Baseline - Clinician- and Administrative-reported form. It has to be filled in at patient's entry into the set. Collecting Patient-Reported Outcome Measures: Medical Outcomes Study: 36-Item Short Form Survey Instrument Version 1 (SF-36). http://www. rand.org/health/surveys_tools/mos/mos_ core_36item_survey.html UCLA 3-Item Loneliness Scale. Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT (2004) A short scale for measuring loneliness in large surveys: Results from two population-based studies. Res Aging 26(6):655–672. Barthel Index. Mahoney FI, Barthel D. “Functional evaluation: the Barthel Index.” Maryland State Med Journal 1965;14:56-61. ASCOT Toolkit. As a license agreement is needed for use of this questionnaire, only the total score will be included in this version oh the standard set. Canadian Study on Health & Aging Clinical Frailty Scale. As a permission is needed for use of this questionnaire, only the total score will be included in this version oh the standard set. Reference: Akpan A, Roberts C, Bandeen-Roche K, et al. Standard set of health outcome measures for older persons. BMC Geriatr. 2018;18(1):36. Published 2018 Feb 2. doi:10.1186/s12877-017-0701-3 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797357/) The Standard set of ICHOM was supported by NHS England. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Baseline Lymphoma Disease Activity and Assessment

- 9/20/21 - 1 form, 1 itemgroup, 20 items, 1 language
Itemgroup: Lymphoma disease activity
AIDS-Related Non-Hodgkin's Lymphoma Baseline Lymphoma Disease Activity and Assessment (LAA) Combination Chemotherapy Followed by Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin's Lymphoma NCT00310128 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=11409201-BB50-09A2-E044-0003BA3F9857

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D - study documentation

- 9/20/21 - 1 form, 47 itemgroups, 279 items, 2 languages
Itemgroups: ChecklistDemographics,Header Module,Registration Header,Registration characteristics,Contact Person For Pathology Results,Patient Demographics,Eligibility Screening Form,Randomization,Informed consent,Gynaecological examination,Patient Status,ECG,Cardiac Monitoring,Local Her2 Results,Hormonal Receptor Status,History Of Primary Breast Cancer,History Of Primary Cancer (continued),Sentinel Node Sampling,Most Extensive Primary Surgery,Axillary Node Dissection,Chemotherapy,Previous Or Current Cardiovascular Disease,ECG,Translational Research,Central Her2 Testing Form - FISH,Central Her2 Testing Form - IHC,Radiotherapy,Hormonetherapy,Concomitant Treatment,Administration of Study Drug,Post-Event-Treatment,Chemotherapy,Targeted Therapy,Hormonetherapy,Radiotherapy,Surgery,Adverse Event (AE),Second Primary Malignancy and Contralateral Breast Cancer,On Study - Years 6, 7, 8, 9, and 10,Patient Status,Cardiac Monitoring,Mammogram,Hematoly and Biochemistry,Survival Follow-Up,Treatment Completion,Additional Comments ,Death Form
A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer

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