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402 result(s) for "Findlay, Lisa"
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Predictors of Residual Disease After Breast Conservation Surgery
IntroductionBreast-conserving therapy is the standard of care for early-stage breast cancer. In the era of multimodality therapy, the debate on the value of revision surgery for compromised margins continues, and high re-excision rates persist despite updated guidelines. Our study sought to identify the local re-excision rate for compromised margins after lumpectomy, and identify predictors of residual disease at re-excision.MethodsThis population-based retrospective cohort study included women with breast cancer who underwent a lumpectomy between 2009 and 2012 in Manitoba, with close (≤ 2 mm) or positive margins that led to re-excision. Patient demographics and tumor characteristics were identified through provincial cancer registries and chart reviews. For patients with invasive cancer, the six anatomical margins were reported for margin status, width, and pathology type at the margin.ResultsOf the 2494 patients identified, 556 women underwent re-excision, yielding a re-excision rate of 22.29%. Of our 311 patients with invasive cancer who underwent re-excision, 62.7% had residual disease identified on revision. On univariable analysis, the size and grade of the invasive component, nodal stage, and the number of positive margins were associated with residual disease on re-excision (p < 0.05). With the exception of nodal stage, the same variables remained statistically significant on multivariable analysis.ConclusionsOur results suggest that even in the absence of ‘no ink on tumor’, the cancer size and grade in lumpectomy specimens are high-risk factors for residual disease, and this subgroup of patients may benefit from re-excision. Long-term follow-up of this cohort is required to determine their risk of recurrence after adjuvant treatment.
REACH: study protocol of a randomised trial of rehabilitation very early in congenital hemiplegia
ObjectivesCongenital hemiplegia is the most common form of cerebral palsy (CP). Children with unilateral CP show signs of upper limb asymmetry by 8 months corrected age (ca) but are frequently not referred to therapy until after 12 months ca. This study compares the efficacy of infant-friendly modified constraint-induced movement therapy (Baby mCIMT) to infant friendly bimanual therapy (Baby BIM) on upper limb, cognitive and neuroplasticity outcomes in a multisite randomised comparison trial.Methods and analysis150 infants (75 in each group), aged between 3 and 6 months ca, with asymmetric brain injury and clinical signs of upper extremity asymmetry will be recruited. Children will be randomised centrally to receive equal doses of either Baby mCIMT or Baby BIM. Baby mCIMT comprises restraint of the unimpaired hand using a simple restraint (eg, glove, sock), combined with intensive parent implemented practice focusing on active use of the impaired hand in a play-based context. In contrast, Baby BIM promotes active play requiring both hands in a play-based context. Both interventions will be delivered by parents at home with monthly home visits and interim telecommunication support by study therapists. Assessments will be conducted at study entry; at 6, 12 months ca immediately postintervention (primary outcome) and 24 months ca (retention). The primary outcome will be the Mini-Assisting Hand Assessment. Secondary outcomes include the Bayley Scale for Infant and Toddler Development (cognitive and motor domains) and the Hand Assessment of Infants. A subset of children will undertake MRI scans at 24 months ca to evaluate brain lesion severity and brain (re)organisation after intervention.Ethics and disseminationFull ethical approvals for this study have been obtained from the relevant sites. The findings will be disseminated in peer-reviewed publications.Trial registration numberAustralian and New Zealand Clinical Trials Registry: ACTRN12615000180516, Pre results.
UP-BEAT (Upper Limb Baby Early Action–observation Training): protocol of two parallel randomised controlled trials of action–observation training for typically developing infants and infants with asymmetric brain lesions
Introduction Infants with asymmetric brain lesions are at high risk of developing congenital hemiplegia. Action–observation training (AOT) has been shown to effectively improve upper limb motor function in adults with chronic stroke. AOT is based on action observation, whereby new motor skills can be learnt by observing motor actions. This process is facilitated by the Mirror Neuron System, which matches observed and performed motor actions. This study aims to determine the efficacy of AOT in: (1) influencing the early development of reaching and grasping of typically developing infants and (2) improving the upper limb activity of infants with asymmetric brain lesions. Methods and analysis This study design comprises two parallel randomised sham-controlled trials (RCTs) in: (1) typically developing infants (cohort I) and (2) infants with asymmetric brain lesions (eg, arterial stroke, venous infarction, intraventricular haemorrhage or periventricular leukomalacia; cohort II). Cohort II will be identified through a neonatal ultrasound or neonatal MRI. A sham control will be used for both RCTs, taking into consideration that it would be unethical to give no intervention to an at-risk population. Based on a two-tailed t test of two independent means, with a significance (α) level of 0.05, 80% power, predicted effect size of 0.8 and a 90% retention rate, we require 20 participants in each group (total sample of 40) for cohort I. The sample size for cohort II was based on the assumption that the effect size of the proposed training would be similar to that found by Heathcock et al in preterm born infants (n=26) with a mean effect size of 2.4. Given the high effect size, the calculation returned a sample of only four participants per group, on a two-tailed t test, with a significance (α) level of 0.05 and 80% power. As cohort II will consist of two subgroups of lesion type (ie, arterial stroke and venous infarction), we have quadrupled the sample to include 16 participants in each group (total sample of 32). Infants will be randomised to receive either AOT or standard Toy Observation Training (TOT). Both interventions will be of 4 weeks’ duration, from the infant's 9th–13th post-term week of age. Three sessions of 5 min each will be performed each day for 6 days/week (total of 6 h over 28 days). Parents of the AOT group will repeatedly show the infant a grasping action on a set of three toys, presented in random order. Parents of the TOT group will show the infant the same set of three toys, in random order, without demonstrating the grasping action. At 14, 16 and 18 weeks, the quantity and quality of reaching and grasping will be measured using the Grasping and Reaching Assessment of Brisbane; symmetry of reaching and grasping will be measured using the Hand Assessment of Infants (HAI) and pressure of grasping for each hand with a customised pressure sensor. At 6 months’ corrected age, the primary outcome measures will be the HAI and Bayley Scales of Infant and Toddler Development (third edition; BSID III), to measure cognitive and motor development. At 8 months, HAI and EEG will be used to measure brain activity and cortical coherence. At 12 months, the primary outcome measures will again be HAI and BSID III. Dissemination This paper outlines the theoretical basis, study hypotheses and outcome measures for two parallel RCTs comparing the novel intervention Action–observation training with standard TOT in: (1) influencing the early development of reaching and grasping of typically developing infants and (2) improving the upper limb motor activity of infants with asymmetric brain lesions. Trial Registration ACTRN1261100991910. Web address of trial http://www.ANZCTR.org.au/ACTRN12611000991910.aspx
MORE QUESTIONS RAISED BY GLAM 2015-002 CONCERNING THE SECTION 954(d) BRANCH RULES
In a generic legal advice memorandum (GLAM) released Feb 13, 2015 (AM 2015-002), the IRS Office of Chief Counsel (International) expressed what it believes to be the most appropriate method to calculate the actual effective rate of tax (ERT) and the hypothetical ERT for determining whether there is a tax rate disparity under the Section 954(d)(2) regulations (commonly referred to as the \"branch rules\") in the case of certain property manufactured by a controlled foreign corporation. Notwithstanding that a GLAM is intended to apply well-settled law to a generic fact pattern, GLAM 2015-002 arguably establishes new standards and provides guidance under the branch rules not previously articulated, including under the existing regulations, legislative history, and previously issued private letter rulings. This column discusses the application of the GLAM's conclusions, specifically certain inconsistencies between these conclusions and the current final branch rule regulations and prior IRS guidance.
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