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      PREDICT-CP: study protocol of implementation of comprehensive surveillance to predict outcomes for school-aged children with cerebral palsy

      protocol
      1 , 2 , 3 , 2 , 4 , 5 , 1 , 6 , 7 , 8 , 1 , 1 , 2 , 1 , 2 , 9 , 1 , 1 , 1 , 2 , 2 , 2 , 6 , 10 , 1 , 3 , 3 , 8 , 11 , 12 , 12 , 2 , 1 , 1 , 1 , 8 , 9 , 13 , 2 , 14 , 15 , 6
      BMJ Open
      BMJ Open
      cerebral palsy, longitudinal cohort, motor development, brain structure and function, communication, gross motor function, manual ability

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          Abstract

          Objectives

          Cerebral palsy (CP) remains the world’s most common childhood physical disability with total annual costs of care and lost well-being of $A3.87b. The PREDICT-CP (NHMRC 1077257 Partnership Project: Comprehensive surveillance to PREDICT outcomes for school age children with CP) study will investigate the influence of brain structure, body composition, dietary intake, oropharyngeal function, habitual physical activity, musculoskeletal development (hip status, bone health) and muscle performance on motor attainment, cognition, executive function, communication, participation, quality of life and related health resource use costs. The PREDICT-CP cohort provides further follow-up at 8–12 years of two overlapping preschool-age cohorts examined from 1.5 to 5 years (NHMRC 465128 motor and brain development; NHMRC 569605 growth, nutrition and physical activity).

          Methods and analyses

          This population-based cohort study undertakes state-wide surveillance of 245 children with CP born in Queensland (birth years 2006–2009). Children will be classified for Gross Motor Function Classification System; Manual Ability Classification System, Communication Function Classification System and Eating and Drinking Ability Classification System. Outcomes include gross motor function, musculoskeletal development (hip displacement, spasticity, muscle contracture), upper limb function, communication difficulties, oropharyngeal dysphagia, dietary intake and body composition, participation, parent-reported and child-reported quality of life and medical and allied health resource use. These detailed phenotypical data will be compared with brain macrostructure and microstructure using 3 Tesla MRI (3T MRI). Relationships between brain lesion severity and outcomes will be analysed using multilevel mixed-effects models.

          Ethics and dissemination

          The PREDICT-CP protocol is a prospectively registered and ethically accepted study protocol. The study combines data at 1.5–5 then 8–12 years of direct clinical assessment to enable prediction of outcomes and healthcare needs essential for tailoring interventions (eg, rehabilitation, orthopaedic surgery and nutritional supplements) and the projected healthcare utilisation.

          Trial registration number

          ACTRN: 12616001488493

          Related collections

          Most cited references145

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          EuroQol: the current state of play.

          R. Brooks (1996)
          The EuroQol Group first met in 1987 to test the feasibility of jointly developing a standardised non-disease-specific instrument for describing and valuing health-related quality of life. From the outset the Group has been multi-country, multi-centre, and multi-disciplinary. The EuroQol instrument is intended to complement other forms of quality of life measures, and it has been purposefully developed to generate a cardinal index of health, thus giving it considerable potential for use in economic evaluation. Considerable effort has been invested by the Group in the development and valuation aspects of health status measurement. Earlier work was reported upon in 1990; this paper is a second 'corporate' effort detailing subsequent developments. The concepts underlying the EuroQol framework are explored with particular reference to the generic nature of the instrument. The valuation task is reviewed and some evidence on the methodological requirements for measurement is presented. A number of special issues of considerable interest and concern to the Group are discussed: the modelling of data, the duration of health states and the problems surrounding the state 'dead'. An outline of some of the applications of the EuroQol instrument is presented and a brief commentary on the Group's ongoing programme of work concludes the paper.
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            Robust determination of the fibre orientation distribution in diffusion MRI: non-negativity constrained super-resolved spherical deconvolution.

            Diffusion-weighted (DW) MR images contain information about the orientation of brain white matter fibres that potentially can be used to study human brain connectivity in vivo using tractography techniques. Currently, the diffusion tensor model is widely used to extract fibre directions from DW-MRI data, but fails in regions containing multiple fibre orientations. The spherical deconvolution technique has recently been proposed to address this limitation. It provides an estimate of the fibre orientation distribution (FOD) by assuming the DW signal measured from any fibre bundle is adequately described by a single response function. However, the deconvolution is ill-conditioned and susceptible to noise contamination. This tends to introduce artefactual negative regions in the FOD, which are clearly physically impossible. In this study, the introduction of a constraint on such negative regions is proposed to improve the conditioning of the spherical deconvolution. This approach is shown to provide FOD estimates that are robust to noise whilst preserving angular resolution. The approach also permits the use of super-resolution, whereby more FOD parameters are estimated than were actually measured, improving the angular resolution of the results. The method provides much better defined fibre orientation estimates, and allows orientations to be resolved that are separated by smaller angles than previously possible. This should allow tractography algorithms to be designed that are able to track reliably through crossing fibre regions.
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              A report: the definition and classification of cerebral palsy April 2006.

              For a variety of reasons, the definition and the classification of cerebral palsy (CP) need to be reconsidered. Modern brain imaging techniques have shed new light on the nature of the underlying brain injury and studies on the neurobiology of and pathology associated with brain development have further explored etiologic mechanisms. It is now recognized that assessing the extent of activity restriction is part of CP evaluation and that people without activity restriction should not be included in the CP rubric. Also, previous definitions have not given sufficient prominence to the non-motor neurodevelopmental disabilities of performance and behaviour that commonly accompany CP, nor to the progression of musculoskeletal difficulties that often occurs with advancing age. In order to explore this information, pertinent material was reviewed on July 11-13, 2004 at an international workshop in Bethesda, MD (USA) organized by an Executive Committee and participated in by selected leaders in the preclinical and clinical sciences. At the workshop, it was agreed that the concept 'cerebral palsy' should be retained. Suggestions were made about the content of a revised definition and classification of CP that would meet the needs of clinicians, investigators, health officials, families and the public and would provide a common language for improved communication. Panels organized by the Executive Committee used this information and additional comments from the international community to generate a report on the Definition and Classification of Cerebral Palsy, April 2006. The Executive Committee presents this report with the intent of providing a common conceptualization of CP for use by a broad international audience.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Open (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2017
                12 July 2017
                : 7
                : 7
                : e014950
                Affiliations
                [1 ] departmentQueensland Cerebral Palsy and Rehabilitation Research Centre (QCPRRC) , The University of Queensland , Brisbane, Queensland, Australia
                [2 ] departmentQueensland Paediatric Rehabilitation Service , Lady Cilento Children's Hospital , Brisbane, Queensland, Australia
                [3 ] departmentChildren's Nutrition Research Centre , The University of Queensland , Brisbane, Queensland, Australia
                [4 ] departmentSchool of Health and Rehabilitation Sciences , The University of Queensland , Brisbane, Queensland, Australia
                [5 ] departmentInstitute of Health and Biomedical Innovation , Queensland University of Technology , Brisbane, Queensland, Australia
                [6 ] departmentMenzies Health Institute Queensland , Griffith University , Gold Coast, Queensland, Australia
                [7 ] CSIRO Australian e-Health Research Centre , Canberra, Australia
                [8 ] departmentMedical Imaging, Diagnostic and Interventional Neuroradiology , Royal Brisbane and Women’s Hospital , Brisbane, Queensland, Australia
                [9 ] departmentQueensland Children's Motion Analysis Service , Lady Cilento Children's Hospital , Brisbane, Queensland, Australia
                [10 ] departmentClinical Governance, Education and Research , Gold Coast Health , Brisbane, Queensland, Australia
                [11 ] departmentCentre for Clinical Research , The University of Queensland , Brisbane, Queensland, Australia
                [12 ] departmentDepartment of Developmental Neuroscience , Instituto Di Ricovero E Cura A Carattere Scientifico (IRCCS) , Pisa, Italy
                [13 ] departmentDepartment of Paediatric Orthopaedics , The Mater Health Services , Brisbane, Queensland, Australia
                [14 ] departmentNorwich Medical School , University of East Anglia , Norwich, UK
                [15 ] departmentSchool of Pharmacy , The University of Queensland , Brisbane, Queensland, Australia
                Author notes
                [Correspondence to ] Professor Roslyn N Boyd; r.boyd@ 123456uq.edu.au
                Author information
                http://orcid.org/0000-0001-5395-544X
                Article
                bmjopen-2016-014950
                10.1136/bmjopen-2016-014950
                5734266
                28706091
                8a6517fb-fa13-4688-aa20-ba97d6a32c77
                © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

                This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

                History
                : 17 February 2017
                : 11 April 2017
                : 27 April 2017
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000925, National Health and Medical Research Council;
                Categories
                Paediatrics
                Protocol
                1506
                1719
                Custom metadata
                unlocked

                Medicine
                cerebral palsy,longitudinal cohort,motor development,brain structure and function,communication,gross motor function,manual ability

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