Interrater Reliability of the Wolf Motor Function Test–Functional Ability Scale: Why It Matters

Background. One important objective for clinical trialists in rehabilitation is determining efficacy of interventions to enhance motor behavior. In part, limitation in the precision of measurement presents a challenge. The few valid, low-cost observational tools available to assess motor behavior cannot escape the variability inherent in test administration and scoring. This is especially true when there are multiple evaluators and raters, as in the case of multisite randomized controlled trials (RCTs). One way to enhance reliability and reduce variability is to implement rigorous quality control (QC) procedures. Objective. This article describes a systematic QC process used to refine the administration and scoring procedures for the Wolf Motor Function Test (WMFT)–Functional Ability Scale (FAS). Methods. The QC process, a systematic focus-group collaboration, was developed and used for a phase III RCT, which enlisted multiple evaluators and an experienced WMFT-FAS rater panel. Results. After 3 staged refinements to the administration and scoring instructions, we achieved a sufficiently high interrater reliability (weighted κ = 0.8). Conclusions and Implications. A systematic focus-group process was shown to be an effective method to improve reliability of observational assessment tools for motor behavior in neurorehabilitation. A reduction in noise-related variability in performance assessments will increase power and potentially lower the number needed to treat. Improved precision of measurement can lead to more cost-effective and efficient clinical trials. Finally, we suggest that improved precision in measures of motor behavior may provide more insight into recovery mechanisms than a single measure of movement time alone

Reduced Upper Limb Recovery in Subcortical Stroke Patients With Small Prior Radiographic Stroke

Background: Research imaging costs limit lesion-based analyses in already expensive large stroke rehabilitation trials. Despite the belief that lesion characteristics influence recovery and treatment response, prior studies have not sufficiently addressed whether lesion features are an important consideration in motor rehabilitation trial design.Objective: Using clinically-obtained neuroimaging, evaluate how lesion characteristics relate to upper extremity (UE) recovery and response to therapy in a large UE rehabilitation trial.Methods: We reviewed lesions from 297 participants with mild-moderate motor impairment in the Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) study and their association with motor recovery, measured by the UE Fugl-Meyer (UE-FM). Significant lesion features identified on correlational and bivariate analysis were further analyzed for associations with recovery and therapy response using longitudinal mixed models.Results: Prior radiographic stroke was associated with less recovery on UE-FM in participants with motor impairment from subsequent subcortical stroke (−5.8 points) and in the overall sample (−3.6 points), but not in participants with cortical or mixed lesions. Lesion volume was also associated with less recovery, particularly after subcortical stroke. Every decade increase in age was associated with 1 less point of recovery on UE-FM. Response to specific treatment regimens varied based on lesion characteristics. Subcortical stroke patients experienced slightly less recovery with higher doses of upper extremity task-oriented training. Participants with cortical or mixed lesions experienced more recovery with higher doses of usual and customary therapy. Other imaging features (leukoaraiosis, ischemic vs. hemorrhagic stroke) were not significant.Conclusions: ICARE clinical imaging revealed information useful for UE motor trial design: stratification of persons with and without prior radiographic stroke may be required in participants with subcortical stroke, the majority of motor rehabilitation trial participants. Most of the prior radiographic strokes were small and cortically-based, suggesting even minor prior brain injury remote to the acute stroke lesion may limit spontaneous and therapy-related recovery. Lesion location may be associated with response to different therapy regimens, but the effects are variable and of unclear significance

Late maxillary protraction in patients with unilateral cleft lip and palate : a retrospective study

Objectives: This retrospective study assessed the dentoskeletal effect of late maxillary protraction (LMP; reverse-pull headgear, Class III elastics, and maxillary sutural loosening) in unilateral cleft lip and palate (UCLP) patients versus a control group of untreated UCLP patients. Materials and Methods: Cephalograms taken at age 13 to 14 years (T1) and 17 to 18 years (T2) were used for this study. The study group comprised 18 patients (10 male and 8 female, mean age at start of LMP therapy = 13.4 [0.45] years). A control groups of 17 patients (8 male and 9 female, mean age = 13.5 [0.44] years) was used for comparison. Results: The repeated-measures analysis of variance showed statistically significant changes across time between groups for the following variables (mean difference [T2-T1] in the study group, 95% confidence interval): SNA (°) (1.95, 0.75 to 3.15), A ⊥ Na Perp (mm) (1.82, 0.86 to 2.77), CoA (mm) (2.92, 1.53 to 4.31), ANB (°) (3.13, 2.02 to 4.24), Wits (mm) (7.82, 5.01 to 10.54), Mx-Md Diff (mm) (0.62, -1.58 to 2.83), Occl P-SN (°) (-3.98, -5.99 to -1.98), overjet (mm) (8.82, 5.90 to 11.74), FMIA (°) (4.05, -0.05 to 8.15), and IMPA (°) (-5.77, -9.74 to -1.80). Late maxillary protraction created a slight open bite (0.66 mm). Trends for overeruption of mandibular incisors and an increase in lower face height (P = .07 for both) were noted in the study group. Conclusions: Late maxillary protraction produced a combination of skeletal changes (protraction of maxilla, improvement in the maxillo-mandibular skeletal relationship) and dental compensations (counterclockwise rotation of occlusal plane, retroclination of mandibular incisors) in patients with UCLP. Late maxillary protraction was also associated with some unwanted tooth movements (open bite tendency, mandibular incisors overeruption)

Long-term endoscopic management for primary recurrent pyogenic cholangitis

Background: Primary recurrent pyogenic cholangitis (RPC) is characterized by relentless suppurative cholangitis in those with a suspected parasitic injury of the biliary tree. Prior work has demonstrated that the infections recur following “definitive” biliary surgery and long-term percutaneous biliary catheters are poorly tolerated. The aim of this study was to assess whether scheduled surveillance endoscopic retrograde cholangiopancreatography (ERCP) prevents cholangitis in those with RPC. Materials and Methods: Following initial biliary decompression and stone clearance, patients with RPC were offered serial ERCP every 3-6 months to remove accumulating stony debris and to dilate incipient strictures. Review of a large series managed using this approach at the University of California, San Francisco Medical Center was performed. The principle outcome was the development of acute cholangitis requiring hospitalization and whether the episode occurred, while the RPC patient was in compliance with endoscopic surveillance recommendations. Results: Over a period of 10 years, 66 patients with primary RPC were managed for RPC at the University of California, San Francisco. The patients were comprised primarily of first-generation immigrants from Asia though one-quarter had migrated from Latin America and Russia. Episodes of cholangitis were significantly less likely to occur in those undergoing surveillance biliary endoscopy than in those who were not (odds ratio 5.3; P = 0.005). The mean follow-up was 36.1 months. Conclusions: Serial endoscopic treatment of RPC may be used to systematically clear biliary debris and decreases the risk of cholangitis requiring hospitalization. It represents a reasonable initial management strategy for these patients. Surgery and percutaneous management may also be required, but are best performed as part of a multidisciplinary approach

Apriori feasibility testing of randomized clinical trial design in patients with cleft deformities and Class III malocclusion

Objectives: To assess the feasibility of randomizing treatment (surgical vs. non-surgical) for correction of a Class III malocclusion (underbite) resulting from an earlier repair of cleft lip and palate. Materials and methods: Surveys about willingness to accept randomized treatment during adolescence were mailed to the parents of cleft lip and palate patients under the care of Children’s Hospital Los Angeles between 2005 and 2010. The inclusion criteria were patients with cleft lip and palate, Class III malocclusion due to maxillary deficiency, and absence of medical and cognitive contraindications to treatment. Results: Out of 287 surveys, 82 (28%) were completed and returned; 47% of the subjects held a strong treatment preference (95% CI, 35–58%), while 30% were willing to accept randomization (95% CI, 20–41%). Seventy-eight percent would drop out of a randomized trial if dissatisfied with the assigned treatment (95% CI, 67–86%). The three most commonly cited reasons for being unwilling to accept random treatment assignment were 1) the desire for doctors to choose the best treatment, 2) the desire for parents to have input on treatment, and 3) the desire to correct the underbite as early as possible. Conclusion: Based on this study, parents and patients would be unwilling to accept a randomly assigned treatment and would not remain in an assigned group if treatment did not meet expectations. This highlight the limitations associated with randomization trials involving surgical modalities and provide justification for other research models (e.g., cohort studies) to compare two treatment options when randomization is not feasible

Parenteral nutrition prolongs hospital stay in children with nonoperative blunt pancreatic injury: A propensity score weighted analysis.

BackgroundBlunt pancreatic injury is frequently managed nonoperatively in children. Nutritional support practices - either enteral or parenteral - are heterogeneous and lack evidence-based guidelines. We hypothesized that use of parenteral nutrition (PN) in children with nonoperatively managed blunt pancreatic injury would 1) be associated with longer hospital stay and more frequent complications, and 2) differ in frequency by trauma center type.MethodsWe conducted a retrospective cohort study using the National Trauma Data Bank (2007-2016). Children (≤18 years) with blunt pancreatic injury were included. Patients were excluded for duodenal injury, mortality <4 days from admission, or laparotomy. We compared children that received versus those that did not receive PN. Logistic regression was used to model patient characteristics, injury severity, and trauma center type as predictors for propensity to receive PN. Treatment groups were balanced using the inverse probability of treatment weights. Outcomes included hospital length of stay, intensive care unit days, incidence of complications and mortality.Results554 children with blunt pancreatic injury were analyzed. PN use declined in adult centers from 2012 to 2016, but remained relatively stable in pediatric centers. Propensity-weighted analysis demonstrated longer median length of stay in patients receiving PN (14 versus 4 days, rate ratio 2.19 [95% CI: 1.97, 2.43]). Children receiving PN also had longer ICU stay (rate ratio 1.73 [95% CI: 1.30, 2.30]). There was no significant difference in incidence of complications or mortality.ConclusionsUse of PN in children with blunt pancreatic injury that are managed nonoperatively differs between adult and pediatric trauma centers, and is associated with longer hospital stay. Early enteral feeding should be attempted first, with PN reserved for children with prolonged intolerance to enteral feeds.Level of evidenceIII, Retrospective cohort