Emma Kirkpatrick

Effect of parent‐delivered action observation therapy on upper limb function in unilateral cerebral palsy: a randomized controlled trial

To determine whether home‐based, parent‐delivered therapy comprising action observation (AO) and repeated practice (RP) improves upper limb function more than RP alone in children with unilateral cerebral palsy (UCP).

The Tyneside Pegboard Test: development, validation, and observations in unilateral cerebral palsy

The aims of this study were twofold: first, to develop and validate a timed test of unimanual and bimanual dexterity suitable for those with disability affecting hand function; second, to explore relationships between unimanual and bimanual completion times.

Understanding Plain English summaries. A comparison of two approaches to improve the quality of Plain English summaries in research reports

Plain English summaryThere is a need for the authors of research reports to be able to communicate their work clearly and effectively to readers who are not familiar with the research area. The National Institute for Health Research (NIHR), along with a number of other funding bodies and journals, require researchers to write short lay summaries, often termed plain English summaries (PESs), to make research accessible to the general public. Because many researchers write using technical, specialised language, particularly in scientific reports, writing PESs can be challenging. In this study we looked at how to improve the quality of PESs. We took PESs which had been submitted to the NIHR Journals Library and asked authors to rewrite them using new guidance. We also asked an independent medical writer to edit the summaries. We measured the quality of these three versions (original summary, rewritten summary and edited summary) in two ways. First, we asked a group of people who were not specialists in the subject area to read and rate how easy the summaries were to understand. Secondly, we used a well-known measure called the Flesch reading ease score to assess how easy the PESs were to read. We found that there was no difference in how easy people found the summaries to understand across the three versions. However, the PESs that were rewritten by the authors and that were edited by the independent medical writer were both easier to read than the originals. This shows that PESs can be improved and for organisations who feel that employing an independent writer to edit summaries, providing clear, practical guidance to authors may be a cost-effective alternative.AbstractBackgroundPlain English summaries (PES) or lay summaries are often included as part of research reports and journal articles. These summaries are vital to ensure that research findings are accessible and available to non-specialist audiences, for example patients and members of the public.Writing a PES requires the adoption of a different style than is generally used in a traditional scientific report, and researchers can find this challenging. This study explored two possible ways to improve the quality of PESs in the NIHR Journals Library: 1) Providing enhanced guidance to authors and asking them to rewrite the PES and 2) Employing an independent medical writer to edit the PES.MethodsWe compared the three versions of the PES (original, author rewritten and independent writer edited) to assess 1) how easy they were to understand and 2) how easy they were to read. In order to establish how easy PESs were to understand, a group of 60 public reviewers read a set of summaries and rated them on a four point scale from “Did not understand” to “Understood all”. The Flesch reading ease score was used to measure how easy the summaries were to read.ResultsResults indicated no significant difference across the three versions of the PES in terms of ease of understanding. However, both the author rewritten and independent writer edited versions were significantly easier to read than the original. There was no significant difference in ease of reading between these two versions.ConclusionThese findings suggest that employing independent medical writers to edit PESs and providing clear, practical guidance to authors are two ways in which the readability of PESs could be improved. Results have implications for journal editors and publishers seeking to enhance accessibility and availability of research findings.

How does the assisting hand assessment relate to relative upper limb movement measured by actigraphy in children with hemiplegia

Objective: To report unique data about children with ALD in a UK-wide prospective study. Methods: Paediatricians notify children with progressive intellectual and neurological deterioration (PIND) via the British Paediatric Surveillance Unit Results: Between April 1997 and May 2014 the PIND study identified 74 boys with ALD. 55 had neurological symptoms, age at presentation: 2–15 years 4 months (median 6yr). Family history was positive in 27, with 13 siblings from 6 sibships; 1 boy had 2 brothers with asymptomatic ALD. There was consanguinity in 3. 46 were white, 5 other ethnicity. Presenting symptoms in 55 symptomatic ALD cases: 42 with deterioration in intellect and/or behaviour, 8 acutely (3: vomiting, 1: recurrent infections, 1: febrile encephalopathy: 1 hemi-seizures,1: collapse and 1: “acutely”),1 with an abnormal gait, 1 with “delayed development” and 3 via positive family history. 21 had visual disturbances, 11 developed seizures. 28 had CT scans: 8 showed a leukoencephalopathy, 8 were normal, 3 showed cerebral infarction and 3 non-specific abnormalities (results not available: 6). 54 had MRI scans: 47 showed a leukoencephalopathy (plus infarct in 2), 2 were normal, 1 showed an infarct (result not available: 4). VLCFAs were abnormal in 52, 53 had synacthen tests which were abnormal in 37 and normal in 3 (results not available:13). Diagnosis was confirmed by genetic studies in 20. Lorenzo’s oil was prescribed for 18. The 19 boys with asymptomatic ALD had a positive family history in 15 including 6 siblings from 3 sibships. 5 had brothers with symptomatic ALD. Conclusions: 8 cases presented acutely without neurological symptoms; some CTs, MRIs and synacthen tests were normal at presentation; some were identified via the family history and cases were increasingly diagnosed using genetic studies. Acknowledgment: Independent research funded by Department of Health (DH) Policy Research Programme [121/6443]. Views expressed not necessarily those of DH. Clinical phenotype of a novel mitochondrial disorder associated with mutations in MICU1 AM CHILDS, C LOGAN, F MUNTONI, G SZABADKAI, M DUCHEN, R PHADKE, C SEWRY, K PYSDEN, H ROPER, G CHOW, E NIKS, M KRIEK, D LEWIS-SMITH, P CHINNERY, E SHERIDAN Department of Paediatric Neurology, Leeds Children’s Hospital; Leeds Institute of Biomedical and Clinical Science, St James’s University Hospital, Leeds, UK; UCL Institute of Child Health, Dubowitz Neuromuscular Centre and Medical Research Council Centre for Neuromuscular Disease, London; Department of Cell and Developmental Biology, Consortium for Mitochondrial Research, University College London, London; Department of Paediatrics, Birmingham Heartlands Hospital, Birmingham, UK; Department of Paediatric Neurology, Queen’s University Hospital, Nottingham; Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands; Mitochondrial Research Group, Institute of Clinical Genetics, Newcastle University

Raising Awareness of the Myth of the “Unaffected Hand” in Childhood Hemiplegia

Background and aims: The term ‘hemiplegia’ implies a unilateral deficit, yet several studies have demonstrated abnormal limb control ipsilateral to the brain lesion. This is under-recognised by clinicians and has implications for function and therapy. We documented deficits in the “unaffected” hand in children with hemiplegia using a dexterity test developed by our group for use in children with motor disorders.Methods: Participants: 33 children (4-11y) with hemiplegia (18 male; 19 left hemiplegia); 66 age, sex and handedness matched controls. Assessment: Adapted 9-hole pegboard test (2 adjacent boards; 3 peg sizes; electronically timed). Analysis: ANOVA (between-group factors group (hemiplegia/control), age (4-5, 6-7, 8-11), sex, dominant hand) performed separately for each peg size.Results: Some hemiplegic children with radiologically confirmed unilateral lesions had prolonged pegboard completion times whereas others scored similarly to controls (Figure: filled symbols - hemiplegia). For all peg sizes, main effects of group (p< 0.001) and age (p< 0.001) were significant but sex and dominant hand were not. There was a significant interaction between group and age (p< 0.005), with smaller difference in group means in the oldest age-group. This deserves exploration with a longitudinal study.FigureConclusion: The “unaffected” hand in children with hemiplegia is less dextrous than the dominant hand of controls. Therapy to improve function of the more-affected hand should be designed to achieve optimal outcomes bilaterally.

Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study

Objectives To assess the value of pilot and feasibility studies to randomised controlled trials (RCTs) funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. To explore the methodological components of pilot/feasibility studies and how they inform full RCTs. Study design Cross-sectional study. Setting Both groups included NIHR HTA programme funded studies in the period 1 January 2010–31 December 2014 (decision date). Group 1: stand-alone pilot/feasibility studies published in the HTA Journal or accepted for publication. Group 2: all funded RCT applications funded by the HTA programme, including reference to an internal and/or external pilot/feasibility study. The methodological components were assessed using an adapted framework from a previous study. Main outcome measures The proportion of stand-alone pilot and feasibility studies which recommended proceeding to full trial and what study elements were assessed. The proportion of ‘HTA funded’ trials which used internal and external pilot and feasibility studies to inform the design of the trial. Results Group 1 identified 15 stand-alone pilot/feasibility studies. Study elements most commonly assessed were testing recruitment (100% in both groups), feasibility (83%, 100%) and suggestions for further study/investigation (83%, 100%). Group 2 identified 161 ‘HTA funded’ applications: 59 cited an external pilot/feasibility study where testing recruitment (50%, 73%) and feasibility (42%, 73%) were the most commonly reported study elements: 92 reported an internal pilot/feasibility study where testing recruitment (93%, 100%) and feasibility (44%, 92%) were the most common study elements reported. Conclusions ‘HTA funded’ research which includes pilot and feasibility studies assesses a variety of study elements. Pilot and feasibility studies serve an important role when determining the most appropriate trial design. However, how they are reported and in what context requires caution when interpreting the findings and delivering a definitive trial.

MENOS4 trial: A multicentre randomised controlled trial (RCT) of a breast care nurse delivered cognitive behavioural therapy (CBT) intervention to reduce the impact of hot flushes in women with breast cancer: Study Protocol

BackgroundWomen who have been treated for breast cancer may identify vasomotor symptoms, such as hot flushes and night sweats (HFNS), as a serious problem. HFNS are unpleasant to experience and can have a significant impact on daily life, potentially leading to reduced adherence to life saving adjuvant hormonal therapy. It is known that Cognitive Behavioural Therapy (CBT) is effective for the alleviation of hot flushes in both well women and women who have had breast cancer. Most women with breast cancer will see a breast care nurse and there is evidence that nurses can be trained to deliver psychological treatments to a satisfactory level, whilst also maintaining treatment fidelity. The research team will assess whether breast care nurses can effectively deliver a CBT intervention to alleviate hot flushes in women with breast cancer.MethodsThis study is a multi-centre phase III individually randomised controlled trial of group CBT versus usual care to reduce the impact of hot flushes in women with breast cancer. 120–160 women with primary breast cancer experiencing seven or more problematic HFNS a week will be randomised to receive either treatment as usual (TAU) or participation in the group CBT intervention plus TAU (CBT Group).A process evaluation using May’s Normalisation Process Theory will be conducted, as well as practical and organisational issues relating to the implementation of the intervention. Fidelity of implementation of the intervention will be conducted by expert assessment. The cost effectiveness of the intervention will also be assessed.DiscussionThere is a need for studies that enable effective interventions to be implemented in practice. There is good evidence that CBT is helpful for women with breast cancer who experience HFNS, yet it is not widely available. It is not yet known whether the intervention can be effectively delivered by breast care nurses or implemented in practice. This study will provide information on both whether the intervention can effectively help women with hot flushes and whether and how it can be translated into routine clinical practice.Trial registrationISRCTN 12824632. Registered 25–01-2017.

Improving communication of clinical trial results: plain English summaries in the NIHR journals library

Background Plain English summaries (PESs) are a valuable tool for making research findings available and accessible to patients and the public. They provide brief descriptions of research written in non-specialist language. The National Institute for Health Research Journals Library (NIHRJL) currently requires authors to provide a 250 word PES. This is published online as part of the final, open-access report. Practice varies among other funders and journals, some of whom employ independent external writers (IEWs) for this purpose.

The utility of PRISMA for abstracts in two cohorts: a comparison of health technology assessment and Cochrane database of systematic reviews 2009-2014.

Background Abstracts of systematic reviews (SRs) play an important role in dissemination of results, with most evidence users consulting the abstract before reading a full article and some only ever consulting the abstract. However, abstracts of SRs are often poorly reported. The PRISMA statement (Liberati et al., 2009) for reporting SRs was extended to include guidelines for the production of abstracts (Beller et al., 2013) to improve this.

Compliance with a parent-delivered play-based therapy approach to upper limb rehabilitation in hemiplegic cerebral palsy

Introduction: Outcome measures can be used to evaluate clinical interventions for children with autism spectrum disorders (ASD), and can inform parents, clinicians, researchers, service providers and policy makers about which interventions are most effective. The aim of this systematic review was to identify outcome measures currently used in the evaluation of anxiety interventions for children with ASD, and to examine their psychometric properties. Participants and Methods: The review was conducted in two stages. First, databases – MEDLINE, EMBASE, ERIC, PsycINFO, and The Cochrane Library – were searched for anxiety treatment group intervention studies for children with high functioning ASD aged 8–14 years, and outcome measures identified from these. Second, articles describing the psychometric properties of these measures were identified using a PubMed quality criteria filter and data extracted using the COSMIN Checklist (Consensus-based Standards for the selection of health Measurement Instruments). Results: Eleven controlled studies were found from which six anxiety outcome measures were identified: Anxiety Disorders Interview Schedule, Spence Children’s Anxiety Scale, Screen for Child Anxiety Related Emotional Disorders, Multidimensional Anxiety Scale for Children, Revised Children’s Anxiety and Depression Scale and Revised Children’s Manifest Anxiety Scale. We identified 70 articles from which data on the quality of evidence about reliability and validity were extracted. Good quality evidence was found about all measures across the quality criteria categories, apart from responsiveness to change. Conclusion: The results provide evidence to guide choice of outcome measures for psychological intervention trials for anxiety for children with high-functioning ASD in middle childhood.Introduction: Findings of enhanced cognitive development in breast‐fed compared with formula‐fed infants suggest that breast milk contains neurodevelopmentally beneficial components. Animal studies ...