The treatment of spasticity with Delta9-tetrahydrocannabinol in persons with spinal cord injury

STUDY DESIGN: Open label study to determine drug dose for a randomized double-blind placebo-controlled parallel study. OBJECTIVES: To assess the efficacy and side effects of oral Delta(9)-tetrahydrocannabinol (THC) and rectal THC-hemisuccinate (THC-HS) in SCI patients. SETTING: REHAB Basel, Switzerland. METHOD: Twenty-five patients with SCI were included in this three-phase study with individual dose adjustment, each consisting of 6 weeks. Twenty-two participants received oral THC open label starting with a single dose of 10 mg (Phase 1, completed by 15 patients). Eight subjects received rectal THC-HS (Phase 2, completed by seven patients). In Phase 3, six patients were treated with oral THC and seven with placebo. Major outcome parameters were the spasticity sum score (SSS) using the Modified Ashworth Scale (MAS) and self-ratings of spasticity. RESULTS: Mean daily doses were 31 mg with THC and 43 mg with THC-HS. Mean SSS for THC decreased significantly from 16.72 (+/-7.60) at baseline to 8.92 (+/-7.14) on day 43. Similar improvement was seen with THC-HS. We observed a significant improvement of SSS with active drug (P=0.001) in the seven subjects who received oral THC in Phase 1 and placebo in Phase 3. Major reasons for drop out were increase of pain and psychological side effects. CONCLUSION: THC is an effective and safe drug in the treatment of spasticity. At least 15-20 mg per day were needed to achieve a therapeutic effect.

Optimal Workflow and Process-Based Performance Measures for Endovascular Therapy in Acute Ischemic Stroke: Analysis of the Solitaire FR Thrombectomy for Acute Revascularization Study.

BACKGROUND AND PURPOSE We report on workflow and process-based performance measures and their effect on clinical outcome in Solitaire FR Thrombectomy for Acute Revascularization (STAR), a multicenter, prospective, single-arm study of Solitaire FR thrombectomy in large vessel anterior circulation stroke patients. METHODS Two hundred two patients were enrolled across 14 centers in Europe, Canada, and Australia. The following time intervals were measured: stroke onset to hospital arrival, hospital arrival to baseline imaging, baseline imaging to groin puncture, groin puncture to first stent deployment, and first stent deployment to reperfusion. Effects of time of day, general anesthesia use, and multimodal imaging on workflow were evaluated. Patient characteristics and workflow processes associated with prolonged interval times and good clinical outcome (90-day modified Rankin score, 0-2) were analyzed. RESULTS Median times were onset of stroke to hospital arrival, 123 minutes (interquartile range, 163 minutes); hospital arrival to thrombolysis in cerebral infarction (TICI) 2b/3 or final digital subtraction angiography, 133 minutes (interquartile range, 99 minutes); and baseline imaging to groin puncture, 86 minutes (interquartile range, 24 minutes). Time from baseline imaging to puncture was prolonged in patients receiving intravenous tissue-type plasminogen activator (32-minute mean delay) and when magnetic resonance-based imaging at baseline was used (18-minute mean delay). Extracranial carotid disease delayed puncture to first stent deployment time on average by 25 minutes. For each 1-hour increase in stroke onset to final digital subtraction angiography (or TICI 2b/3) time, odds of good clinical outcome decreased by 38%. CONCLUSIONS Interval times in the STAR study reflect current intra-arterial therapy for patients with acute ischemic stroke. Improving workflow metrics can further improve clinical outcome. CLINICAL TRIAL REGISTRATION: URL http://www.clinicaltrials.gov. Unique identifier: NCT01327989.

The Coin Rotation Task: A Valid Test for Manual Dexterity in Multiple Sclerosis

BACKGROUND: Impaired manual dexterity is frequent and disabling in patients with multiple sclerosis (MS). Therefore, convenient, quick and validated tests for manual dexterity in MS patients are needed. OBJECTIVE: The aim of this study was to validate the Coin Rotation task (CRT) to examine manual dexterity in patients with MS. DESIGN: Cross-sectional study. METHODS: 101 outpatients with MS were assessed with the CRT, the Expanded Disability Status Scale (EDSS), the Scale for the assessment and rating of ataxia (SARA), the Modified Ashworth Scale (MAS), and their muscle strength and sensory deficits of the hands were noted. Concurrent validity and diagnostic accuracy of the CRT were determined by comparison with the Nine Hole Peg Test (9HPT). Construct validity was determined by comparison with a valid dexterity questionnaire. Multiple regression analysis was done to explore correlations of the CRT with the EDSS, SARA, MAS, muscle strength and sensory deficits. RESULTS: The CRT correlated significantly with the 9HPT (r=.73, p<.0001) indicating good concurrent validity. The cut-off values for the CRT relative to the 9HPT were 18.75 seconds for the dominant (sensitivity: 81.5%; specificity 80.0%) and 19.25 seconds for the non-dominant hand (sensitivity: 90.3%; specificity: 81.8%) demonstrating good diagnostic accuracy. Furthermore, the CRT correlated significantly with the dexterity questionnaire (r=-.49, p<.0001) indicating moderate construct validity. Multiple regression analyses revealed that the EDSS was the strongest predictor for impaired dexterity. LIMITATIONS: Mostly relapsing-remitting MS patients with an EDSS up to 7 were examined. CONCLUSIONS: This study validates the CRT as a test that can be used easily and quickly to evaluate manual dexterity in patients with MS.

Beneficial Effects of a Semi-Intensive Stroke Unit are Beyond the Monitor.

BACKGROUND AND PURPOSE Precise mechanisms underlying the effectiveness of the stroke unit (SU) are not fully established. Studies that compare monitored stroke units (semi-intensive type, SI-SU) versus an intensive care unit (ICU)-based mobile stroke team (MST-ICU) are lacking. Although inequalities in access to stroke unit care are globally improving, acute stroke patients may be admitted to Intensive Care Units for monitoring and followed by a mobile stroke team in hospital's lacking an SU with continuous cardiovascular monitoring. We aimed at comparing the stroke outcome between SI-SU and MST-ICU and hypothesized that the benefits of SI-SU are driven by additional elements other than cardiovascular monitoring, which is equally offered in both care systems. METHODS In a single-center setting, we compared the unfavorable outcomes (dependency and mortality) at 3 months in consecutive patients with ischemic stroke or spontaneous intracerebral hemorrhage admitted to a stroke unit with semi-intensive monitoring (SI-SU) to a cohort of stroke patients hospitalized in an ICU and followed by a mobile stroke team (MST-ICU) during an equal observation period of 27 months. Secondary objectives included comparing mortality and the proportion of patients with excellent outcomes (modified Rankin Score (mRS) 0-1). Equal cardiovascular monitoring was offered in patients admitted in both SI-SU and MST-ICU. RESULTS 458 patients were treated in the SI-SU and compared to the MST-ICU (n = 370) cohort. The proportion of death and dependency after 3 months was significantly improved for patients in the SI-SU compared to MST-ICU (p < 0.001; aOR = 0.45; 95% CI: 0.31-0.65). The shift analysis of the mRS distribution showed significant shift to the lower mRS in the SI-SU group, p < 0.001. The proportion of mortality in patients after 3 months also differed between the MST-ICU and the SI-SU (p < 0.05), but after adjusting for confounders this association was not significant (aOR = 0.59; 95% CI: 0.31-1.13). The proportion of patients with excellent outcome was higher in the SI-SU (59.4 vs. 44.9%, p < 0.001) but the relationship was no more significant after adjustment (aOR = 1.17; 95% CI: 0.87-1.5). CONCLUSIONS Our study shows that moving from a stroke team in a monitored setting (ICU) to an organized stroke unit leads to a significant reduction in the 3 months unfavorable outcome in patients with an acute ischemic or hemorrhagic stroke. Cardiovascular monitoring is indispensable, but benefits of a semi-intensive Stroke Unit are driven by additional elements beyond intensive cardiovascular monitoring. This observation supports the ongoing development of Stroke Centers for efficient stroke care. © 2015 S. Karger AG, Basel.

Progressive multifocal leukoencephalopathy in common variable immunodeficiency: mitigated course under mirtazapine and mefloquine.

Demonstration of survival and outcome of progressive multifocal leukoencephalopathy (PML) in a 56-year-old patient with common variable immunodeficiency, consisting of severe hypogammaglobulinemia and CD4+ T lymphocytopenia, during continuous treatment with mirtazapine (30 mg/day) and mefloquine (250 mg/week) over 23 months. Regular clinical examinations including Rankin scale and Barthel index, nine-hole peg and box and block tests, Berg balance, 10-m walking tests, and Montreal Cognitive Assessment (MoCA) were done. Laboratory diagnostics included complete blood count and JC virus (JCV) concentration in cerebrospinal fluid (CSF). The noncoding control region (NCCR) of JCV, important for neurotropism and neurovirulence, was sequenced. Repetitive MRI investigated the course of brain lesions. JCV was detected in increasing concentrations (peak 2568 copies/ml CSF), and its NCCR was genetically rearranged. Under treatment, the rearrangement changed toward the archetype sequence, and later JCV DNA became undetectable. Total brain lesion volume decreased (8.54 to 3.97 cm(3)) and atrophy increased. Barthel (60 to 100 to 80 points) and Rankin (4 to 2 to 3) scores, gait stability, and box and block (7, 35, 25 pieces) and nine-hole peg (300, 50, 300 s) test performances first improved but subsequently worsened. Cognition and walking speed remained stable. Despite initial rapid deterioration, the patient survived under continuous treatment with mirtazapine and mefloquine even though he belongs to a PML subgroup that is usually fatal within a few months. This course was paralleled by JCV clones with presumably lower replication capability before JCV became undetectable. Neurological deficits were due to PML lesions and progressive brain atrophy.

Addition of magnesium sulphate to ropivacaine for spinal analgesia in dogs undergoing tibial plateau levelling osteotomy

The aim of this blinded, randomised, prospective clinical trial was to determine whether the addition of magnesium sulphate to spinally-administered ropivacaine would improve peri-operative analgesia without impairing motor function in dogs undergoing orthopaedic surgery. Twenty client-owned dogs undergoing tibial plateau levelling osteotomy were randomly assigned to one of two treatment groups: group C (control, receiving hyperbaric ropivacaine by the spinal route) or group M (magnesium, receiving a hyperbaric combination of magnesium sulphate and ropivacaine by the spinal route). During surgery, changes in physiological variables above baseline were used to evaluate nociception. Arterial blood was collected before and after spinal injection, at four time points, to monitor plasma magnesium concentrations. Post-operatively, pain was assessed with a modified Sammarco pain score, a Glasgow pain scale and a visual analogue scale, while motor function was evaluated with a modified Tarlov scale. Assessments were performed at recovery and 1, 2 and 3 h thereafter. Fentanyl and buprenorphine were administered as rescue analgesics in the intra- and post-operative periods, respectively. Plasma magnesium concentrations did not increase after spinal injection compared to baseline. Group M required less intra-operative fentanyl, had lower Glasgow pain scores and experienced analgesia of longer duration than group C (527.0 ± 341.0 min vs. 176.0 ± 109.0 min). However, in group M the motor block was significantly longer, which limits the usefulness of magnesium for spinal analgesia at the investigated dose. Further research is needed to determine a clinically effective dose with shorter duration of motor block for magnesium used as an additive to spinal analgesic agents.

Parental influence on adolescent smoking initiation among Mexican origin youth

Smoking is often initiated in adolescence through trying or experimenting with cigarettes. Smoking initiation is the beginning critical stage in the smoking trajectory often resulting in addiction. This dissertation examined the effect of parenting variables on smoking initiation behavior among 11–14 year old Mexican origin adolescents, a largely understudied group. The participants in this study were part of a population-based cohort of Mexican origin adolescents residing in Houston, Texas. ^ Aim 1 of this study assessed the appropriateness of the Family Life Questionnaire (FLQ) among Mexican origin adolescents. Second order confirmatory factor analysis (CFA) was performed to examine the factor structure of the FLQ and measurement invariance testing was conducted to evaluate the cross-cultural validity of this scale. Aim 2 analyzed cross-sectional associations between parenting variables and adolescent ever tried smoking behavior while aim 3 focused on prospective examination of changes in parenting variables from baseline to final follow-up on ever tried smoking behavior among never smokers. ^ Overall, the results of the CFA indicated that the original factor structure of the FLQ, with alterations, was a good fit for the Mexican origin adolescents. The measurement invariance analysis of the modified FLQ scale indicated adequate measurement invariance. The aim 2 cross-sectional analyses indicated that family cohesion was significantly associated with lower odds of ever tried smoking. Authoritarian parenting was significantly associated with smoking initiation only at the baseline while family conflict was significantly associated with smoking initiation only at the two-year final home visit. The findings from the aim 3 prospective analysis indicated that changes in levels of family cohesion and conflict are important predictors of smoking initiation among those who have never tried smoking. Specifically, perceiving low levels of family cohesion and a decrease in the family cohesion over two years, as well as perceiving high levels of family conflict and an increase in conflict over two years was associated with smoking initiation among never smokers. ^ In general, the findings of this study provide important insights on the links between parenting and adolescent smoking and assist in designing prevention and intervention programs that emphasize the role of family bonding to prevent adolescent smoking behavior. Family education programs for Mexican culture could also highlight the positive effects of authoritarian practices and good family communication to prevent family conflict and subsequent smoking behavior.^

The Aston Medication Adherence Study:mapping the adherence patterns of an inner-city population

Background: The Aston Medication Adherence Study was designed to examine non-adherence to prescribed medicines within an inner-city population using general practice (GP) prescribing data. Objective: To examine non-adherence patterns to prescribed oralmedications within three chronic disease states and to compare differences in adherence levels between various patient groups to assist the routine identification of low adherence amongst patients within the Heart of Birmingham teaching Primary Care Trust (HoBtPCT). Setting: Patients within the area covered by HoBtPCT (England) prescribed medication for dyslipidaemia, type-2 diabetes and hypothyroidism, between 2000 and 2010 inclusively. HoBtPCT's population was disproportionately young,with seventy per cent of residents fromBlack and Minority Ethnic groups. Method: Systematic computational analysis of all medication issue data from 76 GP surgeries dichotomised patients into two groups (adherent and non-adherent) for each pharmacotherapeutic agent within the treatment groups. Dichotomised groupings were further analysed by recorded patient demographics to identify predictors of lower adherence levels. Results were compared to an analysis of a self-reportmeasure of adherence [using the Modified Morisky Scale© (MMAS-8)] and clinical value data (cholesterol values) from GP surgery records. Main outcome: Adherence levels for different patient demographics, for patients within specific longterm treatment groups. Results: Analysis within all three groups showed that for patients with the following characteristics, adherence levels were statistically lower than for others; patients: younger than 60 years of age; whose religion is coded as "Islam"; whose ethnicity is coded as one of the Asian groupings or as "Caribbean", "Other Black" and "African"; whose primary language is coded as "Urdu" or "Bengali"; and whose postcodes indicate that they live within the most socioeconomically deprived areas of HoBtPCT. Statistically significant correlations between adherence status and results from the selfreport measure of adherence and of clinical value data analysis were found. Conclusion: Using data fromGP prescribing systems, a computerised tool to calculate individual adherence levels for oral pharmacotherapy for the treatment of diabetes, dyslipidaemia and hypothyroidism has been developed.The tool has been used to establish nonadherence levels within the three treatment groups and the demographic characteristics indicative of lower adherence levels, which in turn will enable the targeting of interventional support within HoBtPCT. © Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2013.

Atividade eletroencefalográfica de pacientes com acidente vascular cerebral na aprendizagem motora de um jogo baseado em realidade virtual

Stroke is the leading cause of long-term disability among adults and motor relearning is essential in motor sequelae recovery. Therefore, various techniques have been proposed to achieve this end, among them Virtual Reality. The aim of the study was to evaluate electroencephalographic activity of stroke patients in motor learning of a virtual reality-based game. The study included 10 patients with chronic stroke, right-hande; 5 with left brain injury (LP), mean age 48.8 years (± 4.76) and 5 with injury to the right (RP), mean age 52 years (± 10.93). Participants were evaluated for electroencephalographic (EEG) activity and performance while performing 15 repetitions of darts game in XBOX Kinect and also through the NIHSS, MMSE, Fugl-Meyer and the modified Ashworth scale. Patients underwent a trainning with 45 repetitions of virtual darts game, 12 sessions in four weeks. After training, patients underwent reassessment of EEG activity and performance in virtual game of darts (retention). Data were analyzed using ANOVA for repeated measures. According to the results, there were differences between the groups (PD and PE) in frequencies Low Alpha (p = 0.0001), High Alpha (p = 0.0001) and Beta (p = 0.0001). There was an increase in alpha activation powers and a decrease in beta in the phase retention of RP group. In LP group was observed increased alpha activation potency, but without decrease in beta activation. Considering the asymmetry score, RP group increased brain activation in the left hemisphere with the practice in the frontal areas, however, LP group had increased activation of the right hemisphere in fronto-central areas, temporal and parietal. As for performance, it was observed a decrease in absolute error in the game for RP group between assessment and retention (p = 0.015), but this difference was not observed for LP group (p = 0.135). It follows then that the right brain injury patients benefited more from darts game training in the virtual environment with respect to the motor learning process, reducing neural effort in ipsilesionais areas and errors with the practice of the task. In contrast, patients with lesions in left hemisphere decrease neural effort in contralesionais areas important for motor learning and showed no performance improvements with practice of 12 sessions of virtual dart game. Thus, the RV can be used in rehabilitation of stroke patients upper limb, but the laterality of the injury should be considered in programming the motor learning protocol.

Task-oriented training and lower limb strengthening to improve balance and function after stroke: a pilot study

This study investigated the effects of task-oriented training and strengthening of the affected lower limb on balance and function in people who have suffered a stroke. Sixteen male adults, with a mean age of 58 (SD 6.3) years, undergoing outpatient physiotherapy less than 1 month after a single stroke in the territory of the middle cerebral artery were recruited. Participants were allocated to one of two groups: the strengthening group (SG) or control group (CG). The main measures used were the Berg Balance Scale (BBS), Barthel Index (BI) and Modified Ashworth Scale (MAS). After 12 weeks of intervention, both groups showed improvements in outcome measures. For BBS, there was a significant difference between groups, with an increase of 26 points in the SG and 11 points in the CG. For BI, the SG improved by 39 points and the CG improved by 22 points. After intervention, the difference between groups was not significant. For MAS, differences were not significant, showing that for both groups intervention programmes did not increase spasticity. In conclusion, physiotherapy intervention for postural control dysfunctions after stroke seems to benefit from strength training of the affected lower limb and the practising functional tasks. A large randomized controlled trial is recommended to further investigate the effects of this intervention.

Clinical outcome after first and recurrent hemorrhage in patients with untreated brain arteriovenous malformation

Background and Purpose: The morbidity from spontaneous hemorrhage of untreated brain arteriovenous malformations (AVM) is not well described. Methods: The 241 consecutive AVM patients (mean age 3716 years, 52% women) from the prospective Columbia AVM Databank initially presenting with hemorrhage were evaluated using the Rankin Scale (RS) and the National Institute of Health Stroke Scale (NIHSS). From the 241 AVM patients, 29 (12%) had subsequent intracranial hemorrhage during follow-up. For further comparisons, 84 non-AVM patients with intracerebral hemorrhage from the Northern Manhattan Study (NOMAS) served as a control group. Results: In 241 AVM patients presenting with hemorrhage the median RS was 2 and the median NIHSS was 1 (49% RS 0 to 1, 61% NIHSS 2). The median time between hemorrhage and clinical evaluation was 11 days (mean 219 days). Recurrent AVM hemorrhage during follow-up resulted in no significant increase in morbidity (median RS 2, P0.004; median NIHSS 3, P0.322; time between hemorrhage and study evaluation: median 55 days, mean 657 days). Among AVM-hemorrhage subtypes, parenchymatous AVM hemorrhage was associated with higher stroke morbidity (odds ratio, 2.9; 95% CI, 1.5 to 5.8 for NIHSS 2) than nonparenchymatous hemorrhages. Parenchymatous AVM hemorrhage had a significantly better outcome (median NIHSS 1) than non-AVM related hemorrhage (median NIHSS 12; P0.0001). Conclusions: Hemorrhage, either at initial presentation or during follow-up of untreated AVM patients appears to carry

Amphetamine increases blood pressure and heart rate but has no effect on motor recovery or cerebral haemodynamics in ischaemic stroke: a randomized controlled trial (ISRCTN 36285333)

Amphetamine enhances recovery after experimental ischaemia and has shown promise in small clinical trials when combined with motor or sensory stimulation. Amphetamine, a sympathomimetic, might have haemodynamic effects in stroke patients, although limited data have been published. Subjects were recruited 3-30 days post ischaemic stroke into a phase II randomised (1:1), double blind, placebo-controlled trial. Subjects received dexamphetamine (5mg initially, then 10mg for 10 subsequent doses with 3 or 4 day separations) or placebo in addition to inpatient physiotherapy. Recovery was assessed by motor scales (Fugl-Meyer, FM), and functional scales (Barthel index, BI and modified Rankin score, mRS). Peripheral blood pressure (BP), central haemodynamics and middle cerebral artery blood flow velocity were assessed before, and 90 minutes after, the first 2 doses. 33 subjects were recruited, age 33-88 (mean 71) years, males 52%, 4-30 (median 15) days post stroke to inclusion. 16 patients were randomised to placebo and 17 amphetamine. Amphetamine did not improve motor function at 90 days; mean (standard deviation) FM 37.6 (27.6) vs. control 35.2 (27.8) (p=0.81). Functional outcome (BI, mRS) did not differ between treatment groups. Peripheral and central systolic BP, and heart rate, were 11.2 mmHg (p=0.03), 9.5 mmHg (p=0.04) and 7 beats/minute (p=0.02) higher respectively with amphetamine, compared with control. A non-significant reduction in myocardial perfusion (Buckberg Index) was seen with amphetamine. Other cardiac and cerebral haemodynamics were unaffected. Amphetamine did not improve motor impairment or function after ischaemic stroke but did significantly increase BP and heart rate without altering cerebral haemodynamics.

Correlação entre o sinal mecanomiográfico e a escala modificada de Ashworth durante avaliação clínica da espasticidade

Spasticity is a common disorder in people who have upper motor neuron injury. The involvement may occur at different levels. The Modified Ashworth Scale (MAS) is the most used method to measure involvement levels. But it corresponds to a subjective evaluation. Mechanomyography (MMG) is an objective technique that quantifies the muscle vibration during the contraction and stretching events. So, it may assess the level of spasticity accurately. This study aimed to investigate the correlation between spasticity levels determined by MAS with MMG signal in spastic and not spastic muscles. In the experimental protocol, we evaluated 34 members of 22 volunteers, of both genders, with a mean age of 39.91 ± 13.77 years. We evaluated the levels of spasticity by MAS in flexor and extensor muscle groups of the knee and/or elbow, where one muscle group was the agonist and one antagonist. Simultaneously the assessment by the MAS, caught up the MMG signals. We used a custom MMG equipment to register and record the signals, configured in LabView platform. Using the MatLab computer program, it was processed the MMG signals in the time domain (median energy) and spectral domain (median frequency) for the three motion axes: X (transversal), Y (longitudinal) and Z (perpendicular). For bandwidth delimitation, we used a 3rd order Butterworth filter, acting in the range of 5-50 Hz. Statistical tests as Spearman's correlation coefficient, Kruskal-Wallis test and linear correlation test were applied. As results in the time domain, the Kruskal-Wallis test showed differences in median energy (MMGME) between MAS groups. The linear correlation test showed high linear correlation between MAS and MMGME for the agonist muscle as well as for the antagonist group. The largest linear correlation occurred between the MAS and MMG ME for the Z axis of the agonist muscle group (R2 = 0.9557) and the lowest correlation occurred in the X axis, for the antagonist muscle group (R2 = 0.8862). The Spearman correlation test also confirmed high correlation for all axes in the time domain analysis. In the spectral domain, the analysis showed an increase in the median frequency (MMGMF) in MAS’ greater levels. The highest correlation coefficient between MAS and MMGMF signal occurred in the Z axis for the agonist muscle group (R2 = 0.4883), and the lowest value occurred on the Y axis for the antagonist group (R2 = 0.1657). By means of the Spearman correlation test, the highest correlation occurred between the Y axis of the agonist group (0.6951; p <0.001) and the lowest value on the X axis of the antagonist group (0.3592; p <0.001). We conclude that there was a significantly high correlation between the MMGME and MAS in both muscle groups. Also between MMG and MAS occurred a significant correlation, however moderate for the agonist group, and low for the antagonist group. So, the MMGME proved to be more an appropriate descriptor to correlate with the degree of spasticity defined by the MAS.

Calculation of sample size for stroke trials assessing functional outcome: comparison of binary and ordinal approaches

Background Many acute stroke trials have given neutral results. Sub-optimal statistical analyses may be failing to detect efficacy. Methods which take account of the ordinal nature of functional outcome data are more efficient. We compare sample size calculations for dichotomous and ordinal outcomes for use in stroke trials. Methods Data from stroke trials studying the effects of interventions known to positively or negatively alter functional outcome – Rankin Scale and Barthel Index – were assessed. Sample size was calculated using comparisons of proportions, means, medians (according to Payne), and ordinal data (according to Whitehead). The sample sizes gained from each method were compared using Friedman 2 way ANOVA. Results Fifty-five comparisons (54 173 patients) of active vs. control treatment were assessed. Estimated sample sizes differed significantly depending on the method of calculation (Po00001). The ordering of the methods showed that the ordinal method of Whitehead and comparison of means produced significantly lower sample sizes than the other methods. The ordinal data method on average reduced sample size by 28% (inter-quartile range 14–53%) compared with the comparison of proportions; however, a 22% increase in sample size was seen with the ordinal method for trials assessing thrombolysis. The comparison of medians method of Payne gave the largest sample sizes. Conclusions Choosing an ordinal rather than binary method of analysis allows most trials to be, on average, smaller by approximately 28% for a given statistical power. Smaller trial sample sizes may help by reducing time to completion, complexity, and financial expense. However, ordinal methods may not be optimal for interventions which both improve functional outcome

Inter-rater reliability study of the modified Oxford Grading Scale and the Peritron manometer

Objective To evaluate the inter-rater reliability of the modified Oxford Grading Scale and the Peritron manometer. Design All participants were evaluated twice, first by one examiner and 30 days later by a second examiner. Measurements of vaginal squeeze pressure were compared with the results from the palpation test. Participants Nineteen women with a mean age of 23.7 years (range 21 to 28 years). Results Inter-rater reliability for vaginal palpation was fair (kappa = 0.33, 95% confidence interval 0.09 to 0.57). Using the Peritron manometer, the difference between examiners was less than 10 cmH(2)O in 11 of the 19 (58%) cases. The palpation test did not differentiate between weak, moderate, good and strong muscle contractions. This study found fair inter-rater reliability for the modified Oxford Grading Scale and moderate inter-rater reliability for the Peritron manometer. Conclusions The inter-rater reliability of vaginal squeeze pressure measurement using the Peritron manometer is acceptable and can be used in re-evaluations performed by different examiners in clinical practice. However, for research purposes, the ideal situation would be for a single examiner to assess and re-assess the subject. Vaginal palpation is important in the clinical assessment of correctness of a pelvic floor muscle contraction, but this study does not support the use of the modified Oxford Grading Scale as a reliable and valid method to measure and differentiate pelvic floor muscle strength. (C) 2010 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.