Abstract
The optic neuritis treatment trial (ONTT) and subsequent studies have had a tremendous impact on the treatment and prognosis of optic neuritis and multiple sclerosis in adults. The results of these studies have been extrapolated to children; however, pediatric data are sparse. Using the method of prospective preference assessment, the willingness of parents and medical professionals to enroll children in a hypothetical Pediatric ONTT was assessed using a mock consent form and questionnaire. A three-arm trial was proposed: (1) intravenous corticosteroids, (2) high-dose oral corticosteroids, and (3) an oral placebo. The forms were completed by 198 parents and 49 physicians. After reviewing the hypothetical scenario, trial design, risks and benefits, and alternatives to the study, 21% of parents would enroll their children in the trial whereas 98% of medical professionals would enroll their patients. With medical professional recommendation, 43% of parents would enroll their children. The manner in which this hypothetical trial was presented to parents, specifically with respect to the recommendation of their child’s health care team, influenced a parent’s willingness to participate.
Highlights
Optic neuritis is an acute, inflammatory disease of the optic nerve and is often the initial manifestation of multiple sclerosis (MS) in adults and children (Duquette et al, 1987; Sindern et al, 1992; Boiko et al, 2002; Optic Neuritis Study Group, 2008a; Bonhomme et al, 2009)
The optic neuritis treatment trial (ONTT) has shown that the administration of intravenous corticosteroids hastens visual recovery, but does not affect the long-term visual or neurologic prognosis when compared to placebo (Optic Neuritis Study Group, 2008b)
Questionnaires were returned by 206 parents; the primary trial design question was only answered by 198 parents (85% response rate; Table 1); 8 partially completed questionnaires were excluded from the analysis for insufficient data
Summary
Optic neuritis is an acute, inflammatory disease of the optic nerve and is often the initial manifestation of multiple sclerosis (MS) in adults and children (Duquette et al, 1987; Sindern et al, 1992; Boiko et al, 2002; Optic Neuritis Study Group, 2008a; Bonhomme et al, 2009). The clinical profile may include sudden vision loss, dyschromatopsia, pain with eye movements, and visual field defects (Optic Neuritis Study Group, 1991; Beck et al, 1992). The optic neuritis treatment trial (ONTT) has shown that the administration of intravenous corticosteroids hastens visual recovery, but does not affect the long-term visual or neurologic prognosis when compared to placebo (Optic Neuritis Study Group, 2008b). Despite insufficient evidence in the pediatric age group of long-term efficacy and the potential for adverse reactions even with short-term therapy, most pediatric ophthalmologists and neurologists still prescribe a short course of intravenous corticosteroids as treatment for acute optic neuritis in children, largely based on the results of the adult trial (Cakmakli et al, 2009). The extrapolation of adult data may be unsafe, and regulatory agencies are demanding additional research in pediatrics, including neurology, ophthalmology, and the use of immunomodulating drugs (Roberts et al, 2003; Ward and Kauffman, 2007)
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