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Patient Reported Outcomes

Patient reported outcomes are an important component of the overall assessment of subjects in clinical studies. IMACS has agreed to incorporate patient-reported outcomes in all myositis trials and clinical studies. This includes a generic health-related quality of life measure that is age appropriate (adult vs. pediatric), and a measure of fatigue, which is under development.

 

These and other quality of life tools, as well as their validation, and performance characteristics, have been reviewed in the following article:

  • Rider LG, Werth VP, Huber AM, Alexanderson H, Rao AP, Ruperto N, Herbelin L, Barohn R, Isenberg D, Miller FW. Measures of adult and juvenile dermatomyositis, polymyositis, and inclusion body myositis: Physician and Patient/Parent Global Activity, Manual Muscle Testing (MMT), Health Assessment Questionnaire (HAQ)/Childhood Health Assessment Questionnaire (C-HAQ), Childhood Myositis Assessment Scale (CMAS), Myositis Disease Activity Assessment Tool (MDAAT), Disease Activity Score (DAS), Short Form 36 (SF-36), Child Health Questionnaire (CHQ), physician global damage, Myositis Damage Index (MDI), Quantitative Muscle Testing (QMT), Myositis Functional Index-2 (FI-2), Myositis Activities Profile (MAP), Inclusion Body Myositis Functional Rating Scale (IBMFRS), Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), Cutaneous Assessment Tool (CAT), Dermatomyositis Skin Severity Index (DSSI), Skindex, and Dermatology Life Quality Index (DLQI). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S118-57. doi: 10.1002/acr.20532. Review. [Abstract (http://www.ncbi.nlm.nih.gov/pubmed/22588740) ]

 

Health Related Quality of Life using SF-36/CHQ, PedsQL

Description:

SF-36 for Adults:

IMACS suggests using the Original SF-36® in adult myositis clinical trials and studies. For use of the Original SF-36®, please contact Quality Metric for licensing information at: http://www.qualitymetric.com/products/descriptions/sflicenses.shtml  or http://www.sf-36.org/wantsf.aspx?id=1  .

 

Child Health Questionnaire (CHQ-PF50) for Children:

IMACS suggests using the CHQ-PF50® in myositis clinical trials and studies involving pediatric patients. For use of the CHQ-PF50, contact HealthAct, Inc. at http://www.healthactchq.com/chq.html  . All users will need to register and purchase the CHQ Manual from HealthAct in order to obtain copies of the form for use in their study. The Health Act website provides information regarding terms of use, content, bibliography, translations etc. All translations will be issued only through HealthAct Inc. Some uses may require a license fee (depending on scope, languages, etc), and this will be determined on a case by case basis.

 

Links to licensing requirements for tool:

For the SF-36: http://www.sf-36.org/wantsf.aspx?id=1 

For the CHQ-PF50®: http://www.healthactchq.com/chq.html 

 

References:

  1. Apaz MT, Saad-Magalhães C, Pistorio A, Ravelli A, de Oliveira Sato J, Marcantoni MB, Meiorin S, Filocamo G, Pilkington C, Maillard S, Al-Mayouf S, Prahalad S, Fasth A, Joos R, Schikler K, Mozolova D, Landgraf JM, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation. Health-related quality of life of patients with juvenile dermatomyositis: results from the Pediatric Rheumatology International Trials Organisation multinational quality of life cohort study. Arthritis Rheum. 2009 Apr 15;61(4):509-17. doi: 10.1002/art.24343. [Abstract (http://www.ncbi.nlm.nih.gov/pubmed/19333974) ]
  2. Ponyi A, Borgulya G, Constantin T, Vancsa A, Gergely L, Danko K. Functional outcome and quality of life in adult patients with idiopathic inflammatory myositis. Rheumatology (Oxford). 2004 Sep 20 [Epub ahead of print] [Pub Med (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15381789) ]  
  3. Sultan SM, Ioannou Y, Moss K, Isenberg DA. Outcome in patients with idiopathic inflammatory myositis: morbidity and mortality. Rheumatology (Oxford). 2002 Jan;41(1):22-6. [Pub Med (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11792875) ]  
  4. Ruperto N, Ravelli A, Pistorio A, Malattia C, Cavuto S, Gado-West L, Tortorelli A, Landgraf JM, Singh G, Martini A; Paediatric Rheumatology International Trials Organisation. Cross-cultural adaptation and psychometric evaluation of the Childhood Health Assessment Questionnaire (CHAQ) and the Child Health Questionnaire (CHQ) in 32 countries. Review of the general methodology. Clin Exp Rheumatol. 2001 Jul-Aug;19(4 Suppl 23):S1-9. [Pub Med (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11510308) ]

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