Development and Testing of The Gait Assessment and Intervention Tool (G.A.I.T.): A Measure of Coordinated Gait Components

Recent neuroscience methods have provided the basis upon which to develop effective gait training methods for recovery of the coordinated components of gait after neural injury. We determined that there was not an existing observational measure that was, at once, adequately comprehensive, scored in an objectively-based manner, and capable of assessing incremental improvements in the coordinated components of gait. Therefore, the purpose of this work was to use content valid procedures in order to develop a relatively inexpensive, more comprehensive measure, scored with an objectively-based system, capable of incrementally scoring improvements in given items, and that was both reliable and capable of discriminating treatment response for those who had a stroke. Eight neurorehabilitation specialists developed criteria for the gait measure, item content, and scoring method. In subjects following stroke (\u3e12 months), the new measure was tested for intra- and inter-rater reliability using the Intraclass Correlation Coefficient; capability to detect treatment response using Wilcoxon Signed Ranks Test; and discrimination between treatment groups, using the Plum Ordinal Regression. The Gait Assessment and Intervention Tool (G.A.I.T.) is a 31-item measure of the coordinated movement components of gait and associated gait deficits. It exhibited the following advantages: comprehensive, objective-based scoring method, incremental measurement of improvement within given items. The G.A.I.T. had good intra- and inter-rater reliability (ICC = .98, p = .0001, 95% CI = .95, .99; ICC = .83, p = .007, 95% CI = .32, .96, respectively. The inexperienced clinician who had training, had an inter-rater reliability with an experienced rater of ICC = .99 (p = .0001, CI = .97, .999). The G.A.I.T. detected improvement in response to gait training for two types of interventions: comprehensive gait training (z = −2.93, p = .003); and comprehensive gait training plus functional electrical stimulation (FES; z = −3.3, p = .001). The G.A.I.T. was capable of discriminating between two gait training interventions, showing an additive advantage of FES to otherwise comparable comprehensive gait training (parameter estimate = 1.72, p = .021; CI, .25, 3.1)

Development and Testing of The Gait Assessment and Intervention Tool (G.A.I.T.): A Measure of Coordinated Gait Components

Recent neuroscience methods have provided the basis upon which to develop effective gait training methods for recovery of the coordinated components of gait after neural injury. We determined that there was not an existing observational measure that was, at once, adequately comprehensive, scored in an objectively-based manner, and capable of assessing incremental improvements in the coordinated components of gait. Therefore, the purpose of this work was to use content valid procedures in order to develop a relatively inexpensive, more comprehensive measure, scored with an objectively-based system, capable of incrementally scoring improvements in given items, and that was both reliable and capable of discriminating treatment response for those who had a stroke. Eight neurorehabilitation specialists developed criteria for the gait measure, item content, and scoring method. In subjects following stroke (\u3e12 months), the new measure was tested for intra- and inter-rater reliability using the Intraclass Correlation Coefficient; capability to detect treatment response using Wilcoxon Signed Ranks Test; and discrimination between treatment groups, using the Plum Ordinal Regression. The Gait Assessment and Intervention Tool (G.A.I.T.) is a 31-item measure of the coordinated movement components of gait and associated gait deficits. It exhibited the following advantages: comprehensive, objective-based scoring method, incremental measurement of improvement within given items. The G.A.I.T. had good intra- and inter-rater reliability (ICC = .98, p = .0001, 95% CI = .95, .99; ICC = .83, p = .007, 95% CI = .32, .96, respectively. The inexperienced clinician who had training, had an inter-rater reliability with an experienced rater of ICC = .99 (p = .0001, CI = .97, .999). The G.A.I.T. detected improvement in response to gait training for two types of interventions: comprehensive gait training (z = −2.93, p = .003); and comprehensive gait training plus functional electrical stimulation (FES; z = −3.3, p = .001). The G.A.I.T. was capable of discriminating between two gait training interventions, showing an additive advantage of FES to otherwise comparable comprehensive gait training (parameter estimate = 1.72, p = .021; CI, .25, 3.1)

The SINS trial: A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma

<p>Abstract</p> <p>Background</p> <p>Basal cell carcinoma is the commonest human cancer. Despite increasing incidence it remains poorly researched. While not life threatening it can cause significant cosmetic disfigurement. Imiquimod, a cream which enhances the body's immune response, may help deal with the number of cases that occur in low-risk sites, especially when good cosmetic results and home use without surgery are needed.</p> <p>This study aims 1. To compare excisional surgery with imiquimod cream for nodular or superficial basal cell carcinoma in low risk sites, with respect to 3 year clinical clearance, cost-effectiveness and cosmetic results. 2. To ascertain if certain phenotypic features and gene polymorphisms predict tumour responsiveness to treatment.</p> <p>Methods/Design</p> <p>Five hundred participants with low risk nodular or superficial basal cell carcinoma will be recruited from hospitals to this multi-centre, randomised, parallel group, controlled phase III trial. Treatment in the imiquimod group is for 6 weeks for superficial basal cell carcinoma and 12 weeks for nodular basal cell carcinoma. Both treatment groups are followed up in clinic for 3 years. Primary outcome variable: the proportion of participants with clinical evidence of success (no recurrence) at 3 years. The primary outcome will be compared between the two treatment groups. Secondary outcomes include: i) clinical success at 1, 2 and 5 years, ii) time to first recurrence, iii) cosmetic appearance of lesion site after treatment, iv) level of pain, and v) cost-effectiveness. Safety and tolerability data will also be reported.</p> <p>Discussion</p> <p>This study protocol describes a pragmatic randomised controlled trial which it is hoped will address the above uncertainties. Three-year results will be available towards the end of 2010.</p> <p>Trial registration</p> <p>Meta-register: NCT00066872, Eudract No. 2004-004506-24, ISRCTN48755084.</p

Impact of efalizumab on patient-reported outcomes in high-need psoriasis patients: results of the international, randomized, placebo-controlled Phase III Clinical Experience Acquired with Raptiva (CLEAR) trial [NCT00256139]

BACKGROUND: Chronic psoriasis can negatively affect patients' lives. Assessing the impact of treatment on different aspects of a patient's health-related quality of life (HRQOL) is therefore important and relevant in trials of anti-psoriasis agents. The recombinant humanized IgG(1 )monoclonal antibody efalizumab targets multiple T-cell-dependent steps in the immunopathogenesis of psoriasis. Efalizumab has demonstrated safety and efficacy in several clinical trials, and improves patients' quality of life. Objective: To evaluate the impact of efalizumab on HRQOL and other patient-reported outcomes in patients with moderate to severe plaque psoriasis, including a large cohort of High-Need patients for whom at least 2 other systemic therapies were unsuitable because of lack of efficacy, intolerance, or contraindication. METHODS: A total of 793 patients were randomized in a 2:1 ratio to receive efalizumab 1 mg/kg/wk (n = 529) or placebo (n = 264) for 12 weeks. The study population included 526 High-Need patients (342 efalizumab, 184 placebo). The treatment was evaluated by patients using the HRQOL assessment tools Short Form-36 (SF-36) and Dermatology Life Quality Index (DLQI). Other patient-reported assessments included the Psoriasis Symptom Assessment (PSA), a visual analog scale (VAS) for itching, and the Patient's Global Psoriasis Assessment (PGPA). RESULTS: Efalizumab was associated with improvements at Week 12 from baseline in patient-reported outcomes, both in the total study population and in the High-Need cohort. Among all efalizumab-treated patients, the DLQI improved by 5.7 points from baseline to Week 12, relative to an improvement of 2.3 points for placebo patients (P < .001). Corresponding improvements in DLQI in the High-Need cohort were 5.4 points for efalizumab compared to 2.3 for placebo (P < .001). Improvements from baseline on the SF-36, PSA, PGPA, and itching VAS at Week 12 were also significantly greater in efalizumab-treated patients than for placebo. CONCLUSION: A 12-week course of efalizumab improved HRQOL and other patient-reported outcomes in patients with moderate to severe plaque psoriasis. The benefits of efalizumab therapy in High-Need patients were similar to those observed in the total study population, indicating that the beneficial impact of efalizumab on QOL is consistent regardless of disease severity, prior therapy, or contraindications to previous therapies

German evidence-based guidelines for the treatment of Psoriasis vulgaris (short version)

Psoriasis vulgaris is a common and chronic inflammatory skin disease which has the potential to significantly reduce the quality of life in severely affected patients. The incidence of psoriasis in Western industrialized countries ranges from 1.5 to 2%. Despite the large variety of treatment options available, patient surveys have revealed insufficient satisfaction with the efficacy of available treatments and a high rate of medication non-compliance. To optimize the treatment of psoriasis in Germany, the Deutsche Dermatologische Gesellschaft and the Berufsverband Deutscher Dermatologen (BVDD) have initiated a project to develop evidence-based guidelines for the management of psoriasis. The guidelines focus on induction therapy in cases of mild, moderate, and severe plaque-type psoriasis in adults. The short version of the guidelines reported here consist of a series of therapeutic recommendations that are based on a systematic literature search and subsequent discussion with experts in the field; they have been approved by a team of dermatology experts. In addition to the therapeutic recommendations provided in this short version, the full version of the guidelines includes information on contraindications, adverse events, drug interactions, practicality, and costs as well as detailed information on how best to apply the treatments described (for full version, please see Nast et al., JDDG, Suppl 2:S1–S126, 2006; or http://www.psoriasis-leitlinie.de)