Swipe om te navigeren naar een ander artikel
Thorin L. Geister and Manjari Quintanar-Solares have contributed equally to this work.
To develop a patient-reported outcome measure for spasticity-related pain in children/adolescents (age 2–17 years) with cerebral palsy (CP), the ‘Questionnaire on Pain caused by Spasticity (QPS).’
Using a semi-structured interview guide, concept elicitation interviews on spasticity-related pain in upper and lower limbs were conducted in 21 children and caregiver pairs. Data were used to modify initial QPS modules and develop six draft modules, which were subsequently refined and finalized in four consecutive cognitive interview waves (12 children and caregiver pairs).
To accommodate the broad range in the children’s communication skills, QPS child/adolescent modules were developed in both interviewer-administered and self-administered formats. With the additional parent modules, three QPS modules were developed for each of the upper and lower limb applications. Information gained from the parent/caregiver modules complements the child/adolescent assessment. Parents report observed signs and frequency of pain in the same situations used to capture the child/adolescent reports of pain severity (e.g., rest, usual daily activities, active mobilization, and physically difficult activities). Participating children/adolescents and parents/caregivers reported that the final QPS instruments were comprehensive, relevant to the child’s spasticity-related experience, and easy to understand and complete.
The QPS is a novel instrument for the assessment of spasticity-related pain in children/adolescents with CP that was developed with direct patient input. Its modules allow the use of this instrument in children/adolescents with varied levels of impairment and communication skills.
Center for Disease Control and Prevention. (2012). Facts about cerebral palsy. http://www.cdc.gov/ncbddd/cp/facts.html. Accessed October 3, 2012.
Dickinson, H. O., Parkinson, K. N., Ravens-Sieberer, U., Schirripa, G., Thyen, U., Arnaud, C., et al. (2007). Self-reported quality of life of 8–12-year-old children with cerebral palsy: A cross-sectional European study. Lancet, 369(9580), 2171–2178. doi: 10.1016/S0140-6736(07)61013-7. PubMedCrossRef
Chaleat-Valayer, E., Parratte, B., Colin, C., Denis, A., Oudin, S., Berard, C., et al. (2011). A French observational study of botulinum toxin use in the management of children with cerebral palsy: BOTULOSCOPE. European Journal of Paediatric Neurology, 15(5), 439–448. doi: 10.1016/j.ejpn.2010.04.006. PubMedCrossRef
Delgado, M. R., Hirtz, D., Aisen, M., Ashwal, S., Fehlings, D. L., McLaughlin, J., et al. (2010). Practice parameter: Pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review): Report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology, 74(4), 336–343. doi: 10.1212/WNL.0b013e3181cbcd2f. PubMedCentralPubMedCrossRef
Love, S. C., Novak, I., Kentish, M., Desloovere, K., Heinen, F., Molenaers, G., et al. (2010). Botulinum toxin assessment, intervention and after-care for lower limb spasticity in children with cerebral palsy: International consensus statement. European Journal of Neurology, 17(Suppl 2), 9–37. doi: 10.1111/j.1468-1331.2010.03126.x. PubMedCrossRef
von Baeyer, C. L. (2006). Children’s self-reports of pain intensity: Scale selection, limitations and interpretation. Pain Research Management, 11(3), 157–162.
Cohen, L. L., Lemanek, K., Blount, R. L., Dahlquist, L. M., Lim, C. S., Palermo, T. M., et al. (2008). Evidence-based assessment of pediatric pain. Journal of Pediatric Psychology, 33(9), 939–955; discussion 956-937. doi: 10.1093/jpepsy/jsm103.
Royal College of Nursing. (2009). The recognition and assessment of acute pain in children. http://www.rcn.org.uk/_data/assets/pdf_file/0004/269185/003542.pdf. Accessed November 27, 2012.
Hunt, A., Wisbeach, A., Seers, K., Goldman, A., Crichton, N., Perry, L., et al. (2007). Development of the paediatric pain profile: Role of video analysis and saliva cortisol in validating a tool to assess pain in children with severe neurological disability. Journal of Pain and Symptom Management, 33(3), 276–289. doi: 10.1016/j.jpainsymman.2006.08.011. PubMedCrossRef
Daltroy, L. H., Liang, M. H., Fossel, A. H., & Goldberg, M. J. (1998). The POSNA pediatric musculoskeletal functional health questionnaire: report on reliability, validity, and sensitivity to change. Pediatric Outcomes Instrument Development Group. Pediatric Orthopaedic Society of North America. Journal of Pediatric Orthopedics, 18(5), 561–571. PubMedCrossRef
Landgraf, J. A., Abetz, L., & Ware, J. (1996). The CHQ user’s manual. Boston: The Health Institute, New England Medical Center.
McCarthy, M. L., Silberstein, C. E., Atkins, E. A., Harryman, S. E., Sponseller, P. D., & Hadley-Miller, N. A. (2002). Comparing reliability and validity of pediatric instruments for measuring health and well-being of children with spastic cerebral palsy. Developmental Medicine and Child Neurology, 44(7), 468–476. PubMedCrossRef
Boldingh, E. J., Jacobs-van der Bruggen, M. A., Lankhorst, G. J., & Bouter, L. M. (2004). Assessing pain in patients with severe cerebral palsy: Development, reliability, and validity of a pain assessment instrument for cerebral palsy. Archives of Physical Medicine and Rehabilitation, 85(5), 758–766. PubMedCrossRef
Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., et al. (2011). Content validity—establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: Part 2—assessing respondent understanding. Value Health, 14(8), 978–988. doi: 10.1016/j.jval.2011.06.013. PubMedCrossRef
Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., et al. (2011). Content validity—establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 1—eliciting concepts for a new PRO instrument. Value Health, 14(8), 967–977. doi: 10.1016/j.jval.2011.06.014. PubMedCrossRef
US Food and Drug Administration. (2009). Guidance for industry— patient- reported outcome measures: Use in medical product development to support labeling claims. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf. December 2009.
International Conference on Harmonisation. (1996). ICH harmonised tripartite guideline: Guideline for good clinical practice E6(R1). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf. Accessed December 4, 2012.
McGrath, P. J., Jhonson, G., Goodman, J. T., Schillinger, J., & Dunn, J. (1985). The CHEOPS: A behavioral scale to measure postoperative pain in children. In J. F. Chapman, R. Dubner, & F. Cervero (Eds.), Advances in pain research and therapy (Vol. 9, pp. 395–402). New York: Raven Press.
Merkel, S. I., Voepel-Lewis, T., Shayevitz, J. R., & Malviya, S. (1997). The FLACC: A behavioral scale for scoring postoperative pain in young children. Pediatric Nursing, 23(3), 293–297. PubMed
Beyer, J. E., Denyes, M. J., & Villarruel, A. M. (1992). The creation, validation, and continuing development of the Oucher: A measure of pain intensity in children. Journal of Pediatric Nursing, 7(5), 335–346. PubMed
Irwin, D. E., Varni, J. W., Yeatts, K., & DeWalt, D. A. (2009). Cognitive interviewing methodology in the development of a pediatric item bank: A patient reported outcomes measurement information system (PROMIS) study. Health Qual Life Outcomes, 7, 3. doi: 10.1186/1477-7525-7-3. PubMedCentralPubMedCrossRef
- Qualitative development of the ‘Questionnaire on Pain caused by Spasticity (QPS),’ a pediatric patient‐reported outcome for spasticity‐related pain in cerebral palsy
Thorin L. Geister
- Springer International Publishing