Weitere Artikel dieser Ausgabe durch Wischen aufrufen
Children with chronic conditions experience medical issues over long-term periods of time which can have lasting emotional and social consequences impacting daily life and functioning. Activities and participation outcomes are needed in order to comprehensively assess child-important health in clinical trials. Our objective was to review the extent to which activity and participation outcomes are included in clinical trials of childhood chronic disease and to determine what trial characteristics are associated with their use.
A review of a large clinical trial registration database (clinicaltrials.gov) was conducted over the 2010 calendar year. The measures used to assess primary and secondary endpoints were coded according to the ICF classification system. Trial characteristics that might be associated with activity and participation outcome use such as sponsorship type, intervention type, health condition, whether the trial was focused on pediatric patients, phase of trial and sample size were also extracted and explored with univariable and multivariable regressions.
Four hundred and ninety-nine trials met inclusion criteria, 495 of which had complete information about hypothesized predictors. Only 36 out of 495 trials included an activity and participation outcome as part of the trial evaluation process. Both univariable and multivariable regression models showed that non-drug trials and late phase of trial (phase IV) showed the strongest likelihood with whether a trial would include an activity and participation outcome.
Most registered clinical trials for children with chronic or ongoing medical conditions do not include a comprehensive approach to health outcomes assessment, especially drug trials and early phase trials. Outcome measures in pediatric clinical trials are lagging relative to World Health Organization standards for comprehensive health evaluation.
Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten
Sie möchten Zugang zu diesem Inhalt erhalten? Dann informieren Sie sich jetzt über unsere Produkte:
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.
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. CrossRef
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.
Speight, J., & Barendse, S. M. (2010). FDA guidance on patient reported outcomes. British Medical Journal, 340, c2921.
World Health Organization. (2007). International classification of functioning, disability, and health : Children & youth version : ICF-CY. Geneva: World Health Organization.
World Health Organization. (2001). International classification of functioning, disability and health : ICF. Geneva: World Health Organization.
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.
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.
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.
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.
Institute of Medicine. (2004) Children’s health, the nation’s wealth: Assessing and improving child health, Washington: National Academies Press.
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.
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. CrossRef
- Patient-important activity and participation outcomes in clinical trials involving children with chronic conditions
Olaf Kraus de Camargo
Ricardo M. Fernandes
- Springer International Publishing
Neuer Inhalt/© Stellmach, Neuer Inhalt/© Maturus, Pluta Logo/© Pluta