Development and psychometric testing of a Chinese version of the Fatigue Scale-Children in Taiwan

Aims. The aim of this study was to develop and evaluate the psychometric properties of a Chinese version of the Fatigue Scale-Children (FS-C-C). Background. Cancer-related fatigue is one of the most distressing and prevalent symptoms reported by paediatric oncology patients during and after their cancer treatment. A reliable and valid instrument to measure fatigue is essential to the successful clinical care of paediatric oncology patients in Taiwan who experience this troubling symptom. Design and methods. A total of 108 paediatric oncology Taiwanese patients who were aged 7–12 years participated in this cross-sectional, instrumentation study. The FS-C was translated into Chinese by using an established translation/back-translation method. The psychometric testing of the FS-C-C included internal consistency, content validity, construct validity, convergent validity, criterion-related validity and known-group validity. Results. The FS-C-C achieved an acceptable internal consistency coefficient. Content validity was moderately high (content validity indices ranged from 83–100%). Confirmatory factor analysis supported the three-factor model as an acceptable model fit (the goodness-of-fit index and adjusted goodness-of-fit index both were greater than 0·9; normed fit index, 0·89; root-mean-square residual, 0·15). Although the results did not support the known-group hypothesis, the convergent validity, concurrent validity and predictive validity of the FS-C-C were supported by significant associations with the PedsQL Multidimensional Fatigue Scale, the Anxious/Depressed subscale of the Child Behaviour Checklist and the generic and disease-specific scores on the Quality of Life for Children with Cancer instrument, respectively. Conclusion. Our newly developed FS-C-C is a reliable and valid instrument for the measurement of cancer-related fatigue intensity in Taiwanese children. Relevance to clinical practice. The FS-C-C could provide useful information to guide clinical practice in assessing and managing cancer-related fatigue in childhood cancer patients in Taiwan.     

Trauma and motorcyclists: born to be wild, bound to be injured?

BACKGROUND: Regrettably motorcyclists frequently suffer related significant injuries. Doctors who manage trauma will encounter victims of motorcycle accidents and many aspects of care are unique to these patients due to the protective and performance enhancing equipment used by motorcyclists. This review examines the patterns of major injuries suffered by motorcyclists, the unique aspects of airway, circulatory and spine management, and suggests some interventions, which may allow primary injury prevention for the future. DATA SOURCE: Literature searches of the PubMed, EMBASE and Cochrane library with hand searches and author's experience. INTERVENTIONS: None. DATA SYNTHESIS AND CONCLUSIONS: The airway and (cervical and thoracolumbar) spine cannot be managed effectively in the helmeted patient with a speed hump in place and intubation by direct laryngoscopy is almost impossible with a speed hump in place. Helmets should be removed and the speed hump cut from the leathers. Leathers act as fracture splints, particularly for pelvis and lower extremities. Removal or extensive cutting away of the lower portion of leathers should be considered as part of "circulation", and only take place in a medical facility and in anticipation of circulatory deterioration. Motorcyclists sustaining thoracic spinal damage more frequently than cervical and spinal fractures at multiple levels are common. Back protectors are used commonly and these may be left in situ for extrication on a spinal board, but they should be removed in-hospital to allow full assessment. Injury prevention will require coordinated research and development of a number of key pieces of equipment and design in particular helmets, speed humps and clothing/textiles. In managing the injured motorcyclist in the pre or in-hospital settings, health professionals require greater awareness of the implications of such devices, which at the present time appears largely restricted to motorcycling enthusiasts.     

Task-based functional magnetic resonance imaging prediction of postsurgical cognitive outcomes in temporal lobe epilepsy: A systematic review,meta-analysis,and new data

Task-based functional magnetic resonance imaging (tfMRI) has developed as a common alternative in epilepsy surgery to the intracarotid amobarbital procedure, also known as the Wada procedure. Prior studies have implicated tfMRI as a comparable predictor of postsurgical cognitive outcomes. However, the predictive validity of tfMRI has not been established. This preregistered systematic review and meta-analysis (CRD42020183563) synthesizes the literature predicting postsurgical cognitive outcomes in temporal lobe epilepsy (TLE) using tfMRI. The PubMed and PsycINFO literature databases were queried for English-language articles published between January 1, 2009 and December 31, 2020 associating tfMRI laterality indices or symmetry of task activation with outcomes in TLE. Their references were reviewed for additional relevant literature, and unpublished data from our center were incorporated. Nineteen studies were included in the meta-analysis. tfMRI studies predicted postsurgical cognitive outcomes in left TLE ($\widehat{\rho }$ = −.27, 95% confidence interval [CI] = −.32 to −.23) but not right TLE ($\widehat{\rho }$ = −.02, 95% CI = −.08 to .03). Among studies of left TLE, language tfMRI studies were more robustly predictive of postsurgical cognitive outcomes ($\widehat{\rho }$ = −.27, 95% CI = −.33 to −.20) than memory tfMRI studies ($\widehat{\rho }$ = −.27, 95% CI = −.43 to −.11). Further moderation by cognitive outcome domain indicated language tfMRI predicted confrontation naming ($\widehat{\rho }$ = −.32, 95% CI = −.41 to −.22) and verbal memory ($\widehat{\rho }$ = −.26, 95% CI = −.35 to −.17) outcomes, whereas memory tfMRI forecasted only verbal memory outcomes ($\widehat{\rho }$ = −.37, 95% CI = −.57 to −.18). Surgery type, birth sex, level of education, age at onset, disease duration, and hemispheric language dominance moderated study outcomes. Sensitivity analyses suggested the interval of postsurgical follow-up, and reporting and methodological practices influenced study outcomes as well. These findings intimate tfMRI is a modest predictor of outcomes in left TLE that should be considered in the context of a larger surgical workup.     

Matching-adjusted indirect comparison of bleeding outcomes in severe haemophilia A: Comparing valoctocogene roxaparvovec gene therapy,emicizumab prophylaxis,and FVIII replacement prophylaxis

Introduction

Head-to-head evaluation of valoctocogene roxaparvovec, the first gene therapy approved for haemophilia A, with emicizumab is not available. Therefore, phase 3 trial data were indirectly compared.

Aim

To compare bleeding rates in trials evaluating 6 × 10¹³ vg/kg valoctocogene roxaparvovec (GENEr8-1; NCT03370913), 1.5 mg/kg emicizumab dosed every week (HAVEN 3; NCT02847637), and FVIII prophylaxis (270–902) in participants with severe haemophilia A (FVIII ≤1 IU/dL).

Methods

Valoctocogene roxaparvovec versus emicizumab and FVIII prophylaxis as used in 270–902 versus emicizumab cross-trial comparisons were performed using matching-adjusted indirect comparison (MAIC). Individual participant data from GENEr8-1 and 270–902 were weighted to equalise aggregate participant baseline characteristics from HAVEN 3. After MAIC weighting, annualised bleeding rates (ABR) and proportions of participants without bleeds were compared for treated bleeds, all bleeds, treated joint bleeds, and treated spontaneous bleeds.

Results

After MAIC weighting, ABR for all bleeds was statistically significantly lower with valoctocogene roxaparvovec than emicizumab (rate ratio [95% CI], .55 [.33–.93]). Additionally, significantly higher proportions of participants had no treated joint bleeds (odds ratio [95% CI], 2.75 [1.20–6.31]) and no treated bleeds (3.25 [1.53–6.90]) with valoctocogene roxaparvovec versus emicizumab. When compared with the mainly standard half-life FVIII prophylaxis regimens in 270–902, mean ABRs (except for all bleeds) were significantly lower, and significantly higher proportions reported 0 bleeds for all outcomes with emicizumab.

Conclusion

Valoctocogene roxaparvovec provided generally lower bleeding rates and higher probability of no bleeds, including treated joint bleeds, than emicizumab. Emicizumab was more effective than FVIII prophylaxis regimens used in 270–902.