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Relevancia Evaluación Nuevo primero Antiguo primero

laboratory analysis (resurvey) SHIP-START-2 rheumatism - rheumatism

- 3/7/21 - 1 formulario, 1 itemgroup, 3 items, 2 idiomas
Itemgroup: rheumatism
rheumatism form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name SHIP.SHIP2.LABRE.RE_BLUT.RE_RHEUMA. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

MRT SHIP-START-3 Rheuma

- 3/7/21 - 1 formulario, 1 itemgroup, 1 item, 2 idiomas
Itemgroup: Rheuma
Rheuma form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name SHIP.SHIP3.MRT.MRTASS.MRTRHEUMA. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617 The English version of this form is under development.

ICHOM Inflammatory Arthritis - Baseline and 6-monthly/annually Clinical Form

- 30/4/20 - 1 formulario, 2 itemgroups, 4 items, 1 idioma
Itemgroups: Administrative Data, Treatment-Specific
INFLAMMATORY ARTHRITIS DATA COLLECTION Version 1.0.0 Revised: April 27 th, 2018 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. Conditions: Rheumatoid Arthritis | Psoriatic Arthritis | Ankylosing Spondylitis | Juvenile Idiopathic Arthritis This ODM-file contains Clinical Variables to be administered at baseline visit and every 6 months if the disease is active or annually if the disease is in remission. The following scores are the ones that are integrated into the standard set. There are alternatives for each category: see questionnaire or data collection guide. PAIN: - Numerical Rating Scale (Adult/Paediatric) FATIGUE - Numerical rating Scale (Adult/Paediatric) ACTIVITY LIMITATION: - HAQ-II* (Adult): copyright FORWARD-The National Data Bank for Rheumatic Diseases, arthritis-research.org ; http://bit.ly/HAQIIIA ; Wolfe F, Michaud K, Pincus T. Development and validation of the health assessment questionnaire II: a revised version of the health assessment questionnaire. Arthritis & Rheumatism. 2004;50(10):3296-305. OVERALL EMOTIONAL AND PHYSICAL HEALTH IMPACT - Numerical rating scale (Adult/Paediatric) WORK/SCHOOL/HOUSEWORK ABILITY AND PRODUCTIVITY: - WPAI (Adult): reillyassociates.net/WPAI_General.html, they ask to inform them about publication or presentation of WPAI-data ICHOM was supported for the Inflammatory Arthritis Standard Set by Santeon, Arthritis Research UK, TiH Transparency in Healthcare, Maasstad Ziekenhuis, Karolinska Universitetssjukhuset, and Sheba Academic Medical Center Hospital. Publication: Oude Voshaar MAH, Das Gupta Z, Bijlsma JWJ, et al. International Consortium for Health Outcome Measurement Set of Outcomes That Matter to People Living With Inflammatory Arthritis: Consensus From an International Working Group. Arthritis Care Res (Hoboken). 2019;71(12):1556‐1565. doi:10.1002/acr.23799 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Inflammatory Arthritis - Baseline and Annual Clinical Form

- 30/4/20 - 1 formulario, 3 itemgroups, 31 items, 1 idioma
Itemgroups: Administrative Data, Baseline Condition Factors, Treatment-Specific
INFLAMMATORY ARTHRITIS DATA COLLECTION Version 1.0.0 Revised: April 27 th, 2018 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. Conditions: Rheumatoid Arthritis | Psoriatic Arthritis | Ankylosing Spondylitis | Juvenile Idiopathic Arthritis This ODM-file contains Clinical Variables to be administered at baseline visit and (a large number of the variables) annually. The following scores are the ones that are integrated into the standard set. There are alternatives for each category: see questionnaire or data collection guide. PAIN: - Numerical Rating Scale (Adult/Paediatric) FATIGUE - Numerical rating Scale (Adult/Paediatric) ACTIVITY LIMITATION: - HAQ-II* (Adult): copyright FORWARD-The National Data Bank for Rheumatic Diseases, arthritis-research.org ; http://bit.ly/HAQIIIA ; Wolfe F, Michaud K, Pincus T. Development and validation of the health assessment questionnaire II: a revised version of the health assessment questionnaire. Arthritis & Rheumatism. 2004;50(10):3296-305. OVERALL EMOTIONAL AND PHYSICAL HEALTH IMPACT - Numerical rating scale (Adult/Paediatric) WORK/SCHOOL/HOUSEWORK ABILITY AND PRODUCTIVITY: - WPAI (Adult): reillyassociates.net/WPAI_General.html, they ask to inform them about publication or presentation of WPAI-data ICHOM was supported for the Inflammatory Arthritis Standard Set by Santeon, Arthritis Research UK, TiH Transparency in Healthcare, Maasstad Ziekenhuis, Karolinska Universitetssjukhuset and Sheba Academic Medical Center Hospital. Publication: Oude Voshaar MAH, Das Gupta Z, Bijlsma JWJ, et al. International Consortium for Health Outcome Measurement Set of Outcomes That Matter to People Living With Inflammatory Arthritis: Consensus From an International Working Group. Arthritis Care Res (Hoboken). 2019;71(12):1556‐1565. doi:10.1002/acr.23799 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Inflammatory Arthritis - Patient-reported Form

- 30/4/20 - 1 formulario, 2 itemgroups, 26 items, 1 idioma
Itemgroups: Administrative Data, Patient-Reported Health and Wellbeing
INFLAMMATORY ARTHRITIS DATA COLLECTION Version 1.0.0 Revised: April 27 th, 2018 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. Conditions: Rheumatoid Arthritis | Psoriatic Arthritis | Ankylosing Spondylitis | Juvenile Idiopathic Arthritis This ODM-file contains Patient-reported Variables to be administered at baseline visit and annually. The following scores are the ones that are integrated into the standard set. There are alternatives for each category: see questionnaire or data collection guide. PAIN: - Numerical Rating Scale (Adult/Paediatric) FATIGUE - Numerical rating Scale (Adult/Paediatric) ACTIVITY LIMITATION: - HAQ-II* (Adult): copyright FORWARD-The National Data Bank for Rheumatic Diseases, arthritis-research.org ; http://bit.ly/HAQIIIA ; Wolfe F, Michaud K, Pincus T. Development and validation of the health assessment questionnaire II: a revised version of the health assessment questionnaire. Arthritis & Rheumatism. 2004;50(10):3296-305. OVERALL EMOTIONAL AND PHYSICAL HEALTH IMPACT - Numerical rating scale (Adult/Paediatric) WORK/SCHOOL/HOUSEWORK ABILITY AND PRODUCTIVITY: - WPAI (Adult): reillyassociates.net/WPAI_General.html, they ask to inform them about publication or presentation of WPAI-data ICHOM was supported for the Inflammatory Arthritis Standard Set by Santeon, Arthritis Research UK, TiH Transparency in Healthcare, Maasstad Ziekenhuis, Karolinska Universitetssjukhuset and Sheba Academic Medical Center Hospital. Publication: Oude Voshaar MAH, Das Gupta Z, Bijlsma JWJ, et al. International Consortium for Health Outcome Measurement Set of Outcomes That Matter to People Living With Inflammatory Arthritis: Consensus From an International Working Group. Arthritis Care Res (Hoboken). 2019;71(12):1556‐1565. doi:10.1002/acr.23799 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Eligibility Rheumatoid Arthritis NCT01166620

- 23/6/21 - 1 formulario, 2 itemgroups, 9 items, 1 idioma
Itemgroups: Inclusion Criteria, Exclusion Criteria
Observational Real-world Evaluation of Cost of Infections of Rheumatoid Arthritis (RA) Patients on Biologics; ODM derived from: https://clinicaltrials.gov/show/NCT01166620

Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455 - End of Double Blind - Administrative; Subject Continuation; Phase Conclusion

- 24/3/20 - 1 formulario, 3 itemgroups, 7 items, 1 idioma
Itemgroups: Administrative, Subject Continuation, Phase Conclusion
Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455 - Status of Treatment Blind; Pregnancy Information; Pharmacogenetic Research Withdrawal of Consent; Study Conclusion; Infusion

- 31/3/20 - 1 formulario, 5 itemgroups, 15 items, 1 idioma
Itemgroups: Status of Treatment Blind, Pregnancy Information, Pharmacogenetic Research Withdrawal of Consent, Study Conclusion, Infusion
Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

AID-Register (Kinderrheumatologie) Anamnese - AID-Register Anamnese

- 14/6/16 - 1 formulario, 4 itemgroups, 22 items, 2 idiomas
Itemgroups: Study site, Medication, Complaints, Physical examination
Register für autoinflammatorische Erkrankungen AID-Register (Kinderrheumatologie)(PD Dr. med. Elke Lainka, Prof. Dr. med. Dirk Föll) https://prst.gpoh.de/aid/formulare.asp

AID-Register (Kinderrheumatologie) Therapieblatt - AID-Register Therapieblatt

- 14/6/16 - 1 formulario, 3 itemgroups, 39 items, 1 idioma
Itemgroups: Study site, Treatment sheet, Other treatments
Register für autoinflammatorische Erkrankungen AID-Register (Kinderrheumatologie)(PD Dr. med. Elke Lainka, Prof. Dr. med. Dirk Föll) https://prst.gpoh.de/aid/formulare.asp

AID-Register (Kinderrheumatologie) Visitenblatt - AID-Register Visitenblatt

- 15/6/16 - 1 formulario, 5 itemgroups, 61 items, 1 idioma
Itemgroups: Study site, Visit sheet, Symptoms, Laboratory results, Outcome and treatment decisions
Register für autoinflammatorische Erkrankungen AID-Register (Kinderrheumatologie)(PD Dr. med. Elke Lainka, Prof. Dr. med. Dirk Föll) https://prst.gpoh.de/aid/formulare.asp

AID-Register (Kinderrheumatologie) Diagnoseblatt - AID-Register Diagnoseblatt

- 13/6/16 - 1 formulario, 6 itemgroups, 77 items, 1 idioma
Itemgroups: Study site, Diagnosis sheet, Genetic assessment, Symptoms, Laboratory results, General information
Register für autoinflammatorische Erkrankungen AID-Register (Kinderrheumatologie)(PD Dr. med. Elke Lainka, Prof. Dr. med. Dirk Föll) https://prst.gpoh.de/aid/formulare.asp

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