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• W1563725709 abstract "SIR–We would like to thank Professor Vles for his in-depth comments on our systematic review on the use of intrathecal baclofen in ambulant children and adolescents with spasticity of cerebral origin.1 In our literature search, we found two studies published by Hoving et al2, 3 on the same group of participants. The first paper was a randomized controlled trial (RCT) investigating the efficacy of intrathecal baclofen on children with spastic cerebral palsy (CP) compared with traditional intervention.2 The second paper was a longitudinal follow-up study on the same group of children, who eventually all had an implanted intrathecal baclofen pump. This second paper examined the 2-year safety and 1-year efficacy of intrathecal baclofen using the same outcome measures, namely visual analogue scales assessing individually formulated problems (e.g. ease of care and pain), Gross Motor Function Measure 66 (GMFM-66) for gross motor function, Pediatric Evaluation of Disability Inventory for activities and participation, and Child Health Questionnaire-Parent Form 50 for quality of life.3 We decided to include the latter in our systematic review as it provided more data on the gross motor function of the participants and had a larger sample size than the previous paper. However, the latter study was a case series as it pooled both the intervention and control groups from the previous RCT into one group for data analyses, thus the level of evidence for this study is level IV.4, 5 In the process of preparing this reply, we found an error in Table II of our paper regarding the study by Hoving et al.3 under the heading of ‘Gross motor activities’: the number inside the second bracket should be ‘12/12 with 11 non-ambulant’, not 17/17 as there was only one ambulant participant in the group of 12 participants who were assessed and showed statistically significant improvement in this area with the GMFM-66. Thus the sentence in the last paragraph on page 7 starting ‘Gross motor skills as measured using the GMFM were significantly improved in three studies … (n=51/51 in total)’ should read ‘(n=46/46 in total including 11 non-ambulant participants)’.3 Although the number of participants has changed, the conclusions have not. We are pleased to have been able to correct this error. We acknowledge there was only one participant in this study3 at Gross Motor Function Classification System (GMFCS) level III, which was explicitly stated in the supplementary online table (Table SIII) in our paper. Only this child was included in our review, a similar strategy was used for other studies in the review (Table SIII and Table II). Our clinical question was to review the evidence for the use of intrathecal baclofen on transfers between positions, gross motor activities, and walking in ambulant children with CP. No data were provided on this child’s ambulatory status and quality of gait in the paper so this child was not included in our discussion regarding these outcomes. This child was included in our discussion on gross motor activities as group data on the score of the sitting dimension of the GMFM-66 was provided.3 We do not believe that our conclusion contradicts the consensus statement by Dan et al.6 regarding the work of Hoving et al.3 The conclusion on the efficacy of intrathecal baclofen (when compared with traditional intervention) drawn by Dan et al.6 was specifically on children with severe CP (as participants in the RCT quoted by Dan et al. were at GMFCS levels IV and V6). Our conclusion of the review was specifically on individuals at GMFCS levels I to III. At present, there is no RCT examining the efficacy of intrathecal baclofen on this ambulant group. In addition, as discussed above, the fact that this follow-up study was not an RCT further strengthens our recommendation for high quality rigorous studies on this intervention in the future. It was never our intention to discourage the use of intrathecal baclofen for children with intractable spastic CP; in fact we strongly support the use of intrathecal baclofen for spasticity and/or dystonia in GMFCS levels IV and V.7, 8 As stated in the consensus statement by Dan et al.,6‘the efficacy of ITB has been less well studied in patients in GMFCS levels I–III than in patients at levels IV–V’. We consider our review a step towards identifying existing research gaps for this intervention in this specific population group. We would encourage more rigorous longitudinal studies in the future that provide evidence for ‘identification of the ideal patient for this treatment’.8 We also hope this review will provide research evidence to families (and clinicians) to make an informed decision about interventions for their children." @default.
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• W1563725709 date "2011-10-20" @default.
• W1563725709 modified "2023-10-14" @default.
• W1563725709 title "Pin et al. reply" @default.
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• W1563725709 doi "https://doi.org/10.1111/j.1469-8749.2011.04106.x" @default.
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