Patient-important activity and participation outcomes in clinical trials involving children with chronic conditions

Quality of Life Research

Volumn 23, Issue 3, 2014, Pages 751-757

  Fayed, Nora ^a,b,c   De Camargo, Olaf Kraus ^b,c   Elahi, Inam ^d   Dubey, Ankita ^d   Fernandes, Ricardo M ^e,f   Houtrow, Amy ^g   Cohen, Eyal ^c,d,h  

^a TORONTO WESTERN HOSPITAL   (Canada)

^b MCMASTER UNIVERSITY   (Canada)

^c MCMASTER UNIVERSITY   (Canada)

^d HOSPITAL FOR SICK CHILDREN   (Canada)

^e HOSPITAL DE SANTA MARIA   (Portugal)

^f Instituto de Medicina Molecular   (Portugal)

^g UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^h UNIVERSITY OF TORONTO   (Canada)

Author keywords

Activity and participation; Child; Chronic disease; Clinical trials; Disability and health; International Classification of Functioning; Outcomes assessment; Patient important

Indexed keywords

CHILD; CHRONIC DISEASE; CLASSIFICATION; CLINICAL TRIAL (TOPIC); DAILY LIFE ACTIVITY; FINANCIAL MANAGEMENT; HUMAN; INTERNATIONAL CLASSIFICATION OF FUNCTIONING, DISABILITY AND HEALTH; OUTCOME ASSESSMENT; PATIENT SELECTION; PEDIATRICS; PSYCHOLOGICAL ASPECT; QUALITY OF LIFE; REGRESSION ANALYSIS; REVIEW; SICKNESS IMPACT PROFILE; SOCIAL PARTICIPATION;

ACTIVITIES OF DAILY LIVING; CHILD; CHRONIC DISEASE; CLINICAL TRIALS AS TOPIC; HUMANS; INTERNATIONAL CLASSIFICATION OF FUNCTIONING, DISABILITY AND HEALTH; PATIENT OUTCOME ASSESSMENT; PATIENT SELECTION; PEDIATRICS; QUALITY OF LIFE; REGRESSION ANALYSIS; RESEARCH SUPPORT AS TOPIC; SICKNESS IMPACT PROFILE; SOCIAL PARTICIPATION;

EID: 84897048627     PISSN: 09629343     EISSN: None     Source Type: Journal    
DOI: 10.1007/s11136-013-0483-9     Document Type: Article

References (23)

1. Zhang, B.; & Schmidt, B. (2001). Do we measure the right end points? A systematic review of primary outcomes in recent neonatal randomized clinical trials. Journal of Pediatrics, 138(1), 76-80.
2. Sinha, I. P.; Williamson, P. R.; & Smyth, R. L. (2009). Outcomes in clinical trials of inhaled corticosteroids for children with asthma are narrowly focussed on short term disease activity. PLoS One, 4(7), e6276.
3. Sinha, I. P.; Altman, D. G.; Beresford, M. W.; Boers, M.; Clarke, M.; Craig, J.; et al. (2012). Standard 5: Selection, measurement, and reporting of outcomes in clinical trials in children. Pediatrics, 129(Supplement 3), S146-S152.
4. Schulz, Kenneth F.; Altman, Douglas G.; & Moher, David. (2010). CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. BMC Medicine, 8(1), 18.
5. Jüni, P.; Altman, D. G.; & Egger, M. (2001). Assessing the quality of controlled clinical trials. BMJ, 323(7303), 42-46.
6. Clarke, S. A.; & Eiser, C. (2004). The measurement of health-related quality of life (QOL) in paediatric clinical trials: A systematic review. Health Qual Life Outcomes, 2(1), 66.
7. Cohen, E.; Goldman, R. D.; Ragone, A.; Uleryk, E.; Atenafu, E. G.; Siddiqui, U.; et al. (2010). Child vs adult randomized controlled trials in specialist journals: A citation analysis of trends, 1985-2005. Archives of Pediatrics and Adolescent Medicine, 164(3), 283.
8. Selby, J. V.; Beal, A. C.; & Frank, L. (2012). The Patient-Centered Outcomes Research Institute (PCORI) national priorities for research and initial research agenda. JAMA: The Journal of the American Medical Association, 307(15), 1583-1584.
9. U.S. Food and Drug Administration. (2009). Patient reported outcome measures: Use in medical product development to support labeling claims. Available at: www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm071975.pdf.
10. Speight, J.; & Barendse, S. M. (2010). FDA guidance on patient reported outcomes. British Medical Journal, 340, c2921.
11. World Health Organization. (2007). International classification of functioning, disability, and health: Children & youth version: ICF-CY. Geneva: World Health Organization.
12. World Health Organization. (2001). International classification of functioning, disability and health: ICF. Geneva: World Health Organization.
13. Schiariti, V.; Fayed, N.; Cieza, A.; Klassen, A.; & O'donnell, M. (2010). Content comparison of health-related quality of life measures for cerebral palsy based on the International Classification of Functioning. Disability & Rehabilitation (0), 1-10.
14. Fayed, N.; & Kerr, E. N. (2011). International Journal of Disability, Community & Rehabilitation Available at: http://www.ijdcr.ca/VOL08-03/ articles/fayed.shtml. Accessed 24 February 2011.
15. Fayed, N.; Schiariti, V.; Bostan, C.; Cieza, A.; & Klassen, A. (2011). Health status and QOL instruments used in childhood cancer research: Deciphering conceptual content using World Health Organization definitions. Quality of Life Research, 20(8), 1247-1258.
16. Fayed, N.; Kraus de Camargo, O.; Kerr, E.; Rosenbaum, P.; Dubey, A.; Bostan, C.; Faulhaber, M.; Raina, P.; & Cieza, A. (2012). Generic child health status and quality of life instruments: A review of conceptual content using WHO definitions. Developmental Medicine Child Neurology, 54(12), 1085-1095.
17. Fayed, N. (2011). Linking health and health-related information to the ICF: A systematic review of the literature from 2001 to 2008. Disability Rehability, 1.
18. Institute of Medicine. (2004) Children's health, the nation's wealth: Assessing and improving child health, Washington: National Academies Press.
19. Fayed, N.; Cieza, A.; & Bickenbach, J. (2012). Illustrating child-specific linking issues using the child health questionnaire. American Journal of Physical Medicine and Rehabilitation, 91(13), S189.
20. Cieza, A. (2002). Linking health-status measurements to the international classification of functioning, disability and health. Journal of Rehabilitation Medicine, 34(5), 205.
21. Chafe, R.; Born, K. B.; Slutsky, A. S.; & Laupacis, A. (2011). The rise of people power. Nature, 472(7344), 410-411.
22. Adolfsson, M. (2011). Applying the ICF-CY to identify everyday life situations of children and youth with disabilities. Thesis, School of Education and Communication, Jönköping University.
23. Partridge, N.; & Scadding, J. (2004). The James Lind Alliance: Patients and clinicians should jointly identify their priorities for clinical trials. The Lancet, 364(9449), 1923-1924.