Evaluating the feasibility of a real world pharmacovigilance study (OPTIMISE:MS).

BACKGROUND: Clinical trial populations do not fully reflect routine practice. The power of routinely collected data to inform clinical practice is increasingly recognised. METHODS: The OPTIMISE:MS pharmacovigilance study is a prospective, pragmatic observational study, conducted across 13 UK MS centres. Data were collected at the time of routine clinical visits. The first participant was recruited on 24th May 2019; data were extracted on 11th November 2021. RESULTS: 2112 participants were included (median age 44.0 years; 1570 (72%) female; 1981 (94%) relapsing-remitting MS). 639 (30%) were untreated at study entry, 205 (10%) taking interferon beta/copaxone, 1004 (47%) second/third generation DMT first line and 264 (13%) had escalated from a platform DMT. 342 clinical events were reported, of which 108 infections. There was an increased risk of adverse events in people taking second/third generation DMT (RR 3.45, 95%CI 1.57-7.60, p<0.01 vs no DMT). Unadjusted Poisson regression demonstrated increased incident adverse events in people taking natalizumab (IRR 5.28, 95%CI 1.41-19.74, p<0.05), ocrelizumab (IRR 3.24, 95%CI 1.22-8.62, p<0.05), and GA biosimilar (Brabio) (IRR 4.89, 95%CI 1.31-18.21, p<0.05) vs no DMT. CONCLUSIONS: Routinely collected healthcare data can be used to evaluate DMT safety in people with MS. These data highlight the potential of pragmatic studies to guide understanding of risks and benefits associated with DMT.

The Neurological Hand Deformity Classification for children with cerebral palsy.

BACKGROUND/AIM: The purpose of this study was to evaluate the reliability of the Neurological Hand Deformity Classification and use it to describe changes in hand deformity over time in children with cerebral palsy. METHODS: We identified 114 video clips of 26 children with cerebral palsy, aged 1-18 years (mean = 8.4, SD = 4.2), performing upper-limb tasks at multiple time points (n = 3-8) at least 6 months apart. Using the Neurological Hand Deformity Classification, three observers classified hand deformity in the video clips. Inter- and intra-observer reliabilities were estimated using Fleiss and Cohen's kappa (κ) and the temporal changes in classification of hand deformity were investigated. RESULTS: Inter- and intra-observer reliability respectively were κ = 0.87 and κ = 0.91. Hand deformity was identified in all children at all time points, even before the age of 2 years. Ten children did not change hand classification, wrist flexion increased in eight, and eight showed changes from wrist flexion to extension or vice versa. CONCLUSIONS: The Neurological Hand Deformity Classification is a reliable tool to classify hand deformity in children with cerebral palsy. For more than one-third of children hand deformity classification did not change. For the remaining children, two patterns of change in hand deformity over time were identified. It is recommended that children with cerebral palsy involving their upper limbs be monitored regularly. SIGNIFICANCE OF THE STUDY: This is the first study to document longitudinal changes in hand deformity in children with cerebral palsy.

Casting, splinting, and physical and occupational therapy of hand deformity and dysfunction in cerebral palsy.

The treatment of hand deformity and associated dysfunction is a major focus of physical and occupational therapy for people with CP, as poor grasp and manipulation has potential to impact on many aspects of daily life. To assist therapists in analyzing patterns of movement of the wrist, finger, and thumb musculature at rest and during functional activities, five patterns of deformity commonly seen in the hypertonic hand are described. Interventions that impact on hypertonicity and associated contracture and that facilitate functional use of the hand in the presence of these deformities are discussed. The paucity of evidence from clinical trials on intervention strategies reflects in part the diversity of people with CP and the highly individual functional problems they encounter. While further research is needed on the many possible interventions and how they contribute to maximizing hand function, there is increasing evidence of the value of therapy that is directed to functional outcomes relevant to the individual.

Optimal daily total end range time for contracture: resolution in hand splinting.

Reduced passive range of motion (PROM) of the joints of the hand is a common sequela of traumatic upper limb injury. Although mobilizing splinting is a common modality used by hand therapists to improve PROM, limited empirical evidence is available to guide therapist prescription. This study investigated the importance of the timing of splint application per 24-hour period, daily total end range time (TERT), via a prospective sequential clinical trial. A total of 43 subjects with joint contractures of the hand after traumatic upper limb injury were randomly allocated to one of two splint programs. Subjects in group A used their splint for less than 6 hours per day, and subjects in group B used their splint for 6 to 12 hours per day. Daily TERT was recorded by subjects in a splint diary. Passive torque range of motion (TROM) was used to measure the extent of contracture resolution over four weeks of splinting. High intrarater, interrater, and test-retest reliability of the TROM technique was established for this sample (intraclass correlation coefficients 0.993 to 0.998). Sequential analysis showed a statistically significant preference for group B, daily TERT of 6 to 12 hours per day (p < 0.05). Pretreatment joint stiffness (p = 0.162) and joint type (p = 0.463) did not influence final TROM significantly. These findings help to provide some controlled data from which therapists may base future prescription (dose) of daily TERT.