Sociodemographic disparities in pediatric pain management

The purpose of this chapter is to present a narrative review of research studies examining sociodemographic predictors of disparities in pain management in children and adolescents. Findings from this review suggest that there are racial/ethnic disparities in the management of pain, but it is still not clear whether disparities by age, sex, insurance status, and residential area exist owing to the conflicting results and/or the reduced number of studies published. For the studies in which evidence of sociodemographic disparities exist, it is not clear whether the statistically significant sociodemographic disparities were also clinically meaningful, and the goal is to determine predictors of disparities in pain management. Future studies need to focus on determining the clinical meaningfulness of other findings and systematically testing explanatory models for possible sociodemographic disparities in pediatric pain management. Adequately addressing these gaps will help to advance the science of sociodemographic disparities in pediatric pain management.

A Randomized Computer-Assisted Rehabilitation Trial of Attention in Pediatric Multiple Sclerosis: A Post Hoc Analysis

Cognitive impairment (CI) is a remarkable feature in pediatric-onset multiple sclerosis (POMS). The Symbol Digit Modalities Test (SDMT) is increasingly used to explore CI in MS. Recently, a four-point worsening on the SDMT score has been demonstrated to correlate with a clinically meaningful cognitive worsening in adult MS. We conducted a post hoc analysis of a randomized computer-assisted rehabilitation trial for attention impairment in POMS to test the clinical meaningfulness of the changes in SDMT scores at the end of the trial (delta SDMT). A four-point SDMT cut-off was applied. POMS patients exposed to specific computer training (ST) and non-specific training (nST) were compared. Data of 16 POMS (9 females, age 15.75 ± 1.74 years) patients were analyzed. At the end of the trial, 25% of patients reported no clinically significant changes (−3 to 3), 12.5% a clinically significant worsening (≤−4) and 62.5% a clinically significant improvement (≥4) in the delta SDMT. The proportion of patients reporting a clinically meaningful improvement was significantly (p = 0.008) higher (100%) in patients exposed to ST in comparison to those (25%) exposed to nST. The use of the four-point SDMT cut-off may be useful to assess the clinical meaningfulness of results from cognitive rehabilitation trials.

A Randomised Computer-assisted Rehabilitation Trial of Attention in Pediatric Multiple Sclerosis: A Post-hoc Analysis.

Background: Cognitive decline is one of the most remarkable features of Multiple Sclerosis (MS) and particularly in pediatric onset MS (POMS). The Simbol Digit Modalities Test (SDMT), a simple, brief measure of information processing speed (IPS) has been proposed and it is increasingly used to explore cognitive functions in MS clinical trials. Recently a 4-point worsening on the SDMT score has been demonstrated to significantly correlate with a clinically meaningful cognitive decline.Methods: The primary objective of this post-hoc analysis of a randomised computer-assisted rehabilitation trial for attention impairment in POMS was to test the clinical meaningfulness of the changes of SDMT scores by applying a 4-point SDMT cut-off. POMS exposed to specific computer training (ST) and nonspecific training (nST) were compared. All analyses were post hoc and not pre-specified. To evaluate the clinical meaningfulness of longitudinal changes over time of the SDMT in the ST and nST groups we applied a categorization of the delta SDMT scores (delta SDMT: SDMT score at T1 – SDMT score at T0) as follow: between -3 and 3 = not clinically significant; ≤ - 4 = clinically significant worsening; ≥ 4 = clinically significant improvement. The proportion of patients reporting a clinically significant SMDT improvement were compared between the 2 groups by using the chi-square test.Results: Twenty-five % of POMS reported no clinically significant changes, 12.5% a clinically significant worsening and 62.5% patients a clinically significant improvement in the SDMT score at the end of the training program. The proportion of patients reporting a clinically significant improvement of the SDMT was significantly (p=0.008) higher (100%) in patients exposed to the ST in comparison to that (25%) in nST group. Conclusions: In our RCT the use of the 4-point SDMT cut-off allows us to demonstrate the clinical meaningfulness of the results obtained by a home-based computerized program for retraining attention dysfunction in POMS patients with attention impairment. Further studies are needed to confirm the clinical validity of this cut-off and its applicability in the routine clinical practice setting

Evaluation of multiple sclerosis disability outcome measures using pooled clinical trial data

ObjectiveWe report analyses of a pooled database by the Multiple Sclerosis Outcome Assessments Consortium to evaluate 4 proposed components of a multidimensional test battery.MethodsStandardized data on 12,776 participants, comprising demographics, multiple sclerosis disease characteristics, Expanded Disability Status Scale (EDSS) score, performance measures, and Short Form–36 Physical Component Summary (SF-36 PCS), were pooled from control and treatment arms of 14 clinical trials. Analyses of Timed 25-Foot Walk (T25FW), 9-Hole Peg Test (9HPT), Low Contrast Letter Acuity (LCLA), and Symbol Digit Modalities Test (SDMT) included measurement properties; construct, convergent, and known group validity; and longitudinal performance of the measures individually and when combined into a multidimensional test battery relative to the EDSS and SF-36 to determine sensitivity and clinical meaningfulness.ResultsThe performance measures had excellent test–retest reliability and showed expected differences between subgroups based on disease duration and EDSS level. Progression rates in detecting time to 3-month confirmed worsening were lower for T25FW and 9HPT compared to EDSS, while progression rates for LCLA and SDMT were similar to EDSS. When the 4 measures were analyzed as a multidimensional measure rather than as individual measures, progression on any one performance measure was more sensitive than the EDSS. Worsening on the performance measures analyzed individually or as a multidimensional test battery was associated with clinically meaningful SF-36 PCS score worsening, supporting clinical meaningfulness of designated performance test score worsening.ConclusionThese results support the use of the 4 proposed performance measures, individually or combined into a multidimensional test battery as study outcome measures.