Parent and medical professional willingness to enroll children in a hypothetical pediatric optic neuritis treatment trial

Frontiers in Neurology

Volumn NOV, Issue , 2011, Pages

  Waldman, Amy T ^a   Shumski, Michael J ^a   Jerrehian, Matthew ^a   Liu, Grant T ^a  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Children; Clinical trial; Optic neuritis; Prospective preference assessment

Indexed keywords

EID: 84865853979     PISSN: None     EISSN: 16642295     Source Type: Journal    
DOI: 10.3389/fneur.2011.00075     Document Type: Article

References (27)

1. Beck, R. W., and Cleary, P. A. (1993). Optic neuritis treatment trial. One-year follow-up results. Arch. Ophthalmol. 111, 773-775.
2. Beck, R. W., Cleary, P. A., Anderson, M. M. Jr., Keltner, J. L., Shults, W. T., Kaufman, D. I., Buckley, E. G., Corbett, J. J., Kupersmith, M. J., Miller, N. R., Savino, P. J., Guy, J. R., Trobe, J. D., McCrary, J. A., Smith, C. H., Chrousos, G. A., Thompson, H. S., Katz, B. J., Brodsky, M. C., Goodwin, J. A., Atwell, C. W., and the Optic Neuritis Study Group. (1992). A randomized, controlled trial of cor-ticosteroids in the treatment of acute optic neuritis. N. Engl. J. Med. 326, 581-588.
3. Boiko, A., Vorobeychik, G., Paty, D., Devonshire, V., Sadovnick, D., and the University of British Columbia MS Clinic Neurologists. (2002). Early onset multiple sclerosis: a longitudinal study. Neurology 59, 1006-1010.
4. Bonhomme, G. R.,Waldman, A. T., Balcer, L. J., Daniels, A. B., Tennekoon, G. I., Forman, S., Galetta, S. L., and Liu, G. T. (2009). Pediatric optic neuritis: brain MRI abnormalities and risk of multiple sclerosis. Neu-rology 72, 881-885.
5. Cakmakli, G., Kurne, A., Guven, A., Ser-daroglu, A., Topaloglu, H., Teber, S., and Anlar, B. (2009). Childhood optic neuritis: the pediatric neurol-ogist's perspective. Eur. J. Paediatr. Neurol. 13, 452-457.
6. Caldwell, P. H., Butow, P. N., and Craig, J. C. (2003). Parents' attitudes to children's participation in random-ized controlled trials. J. Pediatr. 142, 554-559.
7. Duquette, P., Murray, T. J., Pleines, J., Ebers, G. C., Sadovnick, D., Weldon, P., Warren, S., Paty, D. W., Upton, A., Hader, W., Nelson, R., Auty, A., Neufeld, B., and Meltzer, C. (1987). Multiple sclerosis in childhood: clinical profile in 125 patients. J. Pediatr. 111, 359-363.
8. Fleishman, J. A., Beck, R. W., Linares, O. A., and Klein, J. W. (1987). Deficits in visual function after resolution of optic neuritis. Ophthalmology 94, 1029-1035.
9. Gross, C. P., Krumholz, H. M., Van Wye, G., Emanuel, E. J., and Wendler, D. (2006). Does random treatment assignment cause harm to research participants? PLoS Med. 3, e188.
10. Halpern, S. D. (2002). Prospective preference assessment: a method to enhance the ethics and efficiency of randomized controlled trials. Control. Clin. Trials 23, 274-288.
11. Halpern, S. D., Metzger, D. S., Berlin, J. A., and Ubel, P. A. (2001). Who will enroll? Predicting participation in a phase II AIDS vaccine trial. J. Acquir. Immune Defic. Syndr. 27, 281-288.
12. Harth, S. C., and Thong, Y. H. (1995). Parental perceptions and attitudes about informed consent in clinical research involving children. Soc. Sci. Med. 41, 1647-1651.
13. Langley, J. M., Halperin, S. A., Mills, E. L., and Eastwood, B. (1998). Parental willingness to enter a child in a controlled vaccine trial. Clin. Invest. Med. 21, 12-16.
14. Nabulsi, M., Khalil, Y., and Makhoul, J. (2011). Parental attitudes towards and perceptions of their children's participation in clinical research: a developing-country perspective. J. Med. Ethics 37, 420-423.
15. Optic Neuritis Study Group. (1991). The clinical profile of optic neuritis: experience of the Optic Neuritis Treatment Trial. Arch. Ophthalmol. 109, 1673-1678.
16. Optic Neuritis Study Group. (2008a). Multiple sclerosis risk after optic neuritis: final ONTT follow-up. Arch. Neurol. 65, 727-732.
17. Optic Neuritis Study Group. (2008b). Visual function 15 years after optic neuritis: a final follow-up report from the Optic Neuritis Treatment Trial. Ophthalmology 115, 1079-1082.
18. Pierro, A., and Spitz, L. (1997). Informed consent in clinical research: the crisis in paediatrics. Lancet 349, 1703.
19. Roberts, R., Rodriguez, W., Murphy, D., and Crescenzi, T. (2003). Pediatric drug labeling: improving the safety and efficacy of pediatric therapies. JAMA 290, 905-911.
20. Sanders, E. A., Volkers, A. C., van der Poel,J. C., and van Lith, G. H. (1986). Estimation of visual function after optic neuritis: a comparison of clin-ical tests. Br. J. Ophthalmol. 70, 918-924.
21. Shilling, V., and Young, B. (2009). How do parents experience being asked to enter a child in a randomised controlled trial? BMC Med. Ethics 10, 1-11. doi:10.1186/1472-6939-10-1
22. Sindern, E., Haas, J., Stark, E., and Wurster, U. (1992). Early onset MS under the age of 16: clinical and par-aclinical features. Acta Neurol. Scand. 86, 280-284.
23. Singhal, N., Oberle, K., Burgess, E., and Huber-Okrainec, J. (2002). Parents' perceptions of research with newborns. J. Perinatol. 22, 57-63.
24. Tait, A. R., Voepel-Lewis, T., and Malviya, S. (2003). Participation of children in clinical research: factors that influence a parent's decision to consent. Anesthesiology 99, 819-825.
25. Tait, A. R., Voepel-Lewis, T., and Malviya, S. (2004). Factors that influence parents' assessments of the risks and benefits of research involv-ing their children. Pediatrics 113, 727-732.
26. Ward, R. M., and Kauffman, R. (2007). Future of pediatric therapeutics: reauthorization of BPCA and PREA. Clin. Pharmacol. Ther. 81, 477-479.
27. Zupancic, J. A., Gillie, P., Streiner, D. L., Watts, J. L., and Schmidt, B. (1997). Determinants of parental authoriza-tion for involvement of newborn infants in clinical trials. Pediatrics 99, e6.