62 research outputs found

    Safety and transparency in surgical innovation

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    Psychophysical and Psychological Factors Affecting Recovery from Acute Balance Disorders

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    Patients with acute vestibular neuritis are traditionally investigated with caloric or rotational examination of the vestibular-ocular reflex. However, clinical outcome is poorly predicted by such vestibular reflex assessments. We hypothesised that symptomatic recovery would depend upon higher order visuo-vestibular compensatory mechanisms. Thirty-one patients were studied in the acute and recovery phases of vestibular neuritis (median 2 days and 10 weeks, respectively). Patients underwent examination of vestibulo-ocular and vestibular-perceptual responses, at threshold and supra-threshold levels. Supra-threshold stimuli (90°/s velocity step rotations) allowed quantification of vestibulo-ocular and vestibulo-perceptual time constants. Additional measures of visual dependency (rod-and-disc task), dizziness symptom load (Vertigo Symptom Scale and Dizziness Handicap Inventory) and psychological factors (including - autonomic arousal, anxiety, depression, fear of bodily sensations) were obtained. Vestibulo-perceptual and vestibulo-ocular thresholds were raised and asymmetric acutely and remained slightly elevated and asymmetric at recovery. Acutely, supra-threshold vestibulo-ocular time constants were shortened and asymmetric. In contrast, perceptual responses were reduced but notably symmetrical. At recovery, vestibulo-ocular supra-threshold responses remained abnormal but perceptual supra-threshold responses normalised. Visual dependency was significantly elevated above normals in both acute and recovery stages. Vertigo symptom recovery was significantly predicted by acute levels of visual dependency (p=0.002), autonomic anxiety (p=0.004). A number of measures were associated with vertigo symptoms at recovery, in addition to visual dependency (p=0.012) and autonomic anxiety (p<0.001), including - anxiety and depression (p<0.003), fear of body sensations (p=0.033), vestibular perceptual thresholds (p=0.017) and caloric canal paresis (p=0.001). Factor Analysis revealed a strong association between clinical outcome, visual dependency and psychological factors, all loading on a single component accounting for 59.15% of the variance. The bilateral suppression of supra-threshold vestibular perception observed acutely represents a hitherto unrecognised central adaptive ‘anti-vertiginous’ mechanism. However, poor symptomatic recovery is best predicted by increased visual dependency and psychological factors. The findings show that long term recovery from unilateral vestibular deficit is mediated by central compensatory mechanisms, including multi-sensory integration and psychological processing

    Psychological interventions for migraine:a systematic review

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    Migraine causes major health impairment and disability. Psychological interventions offer an addition to pharmacotherapy but they are not currently recommended by the National Institute of Clinical Excellence (NICE) or available in the National Health Service. We aimed to systematically review evidence on the efficacy of psychological interventions for migraine in adults. A search was done of MEDLINE, psychINFO, http://www.opengrey.eu, the meta-register of controlled trials and bibliographies. Twenty-four papers were included and rated independently by two people using the Yates scale, which has 35 points. Cochrane recommendations are that high quality reports score above the mid-point (18 points). Methods used in 17/24 papers were rated ‘high quality’. However, frequently descriptions of key areas such as randomisation methods were omitted. Eighteen studies measured effects of psychological interventions on headache-related outcomes, fifteen reporting significant improvements, ranging 20–67 %. Interventions also produced improvements in psychological outcomes. Few trials measured or reported improvement in disability or quality of life. We conclude that evidence supports the efficacy of psychological interventions in migraine. Over half of the studies were from the USA, which did not provide universal health care at the time of the study, so it is difficult to generalise results to typical populations in receipt of publically funded health services. We agree with the NICE recommendation that high quality pragmatic randomised controlled trials are needed in the UK

    Further considerations for placebo controls in surgical trials

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    © 2023. The Author(s).Peer reviewedPublisher PD

    Understanding stage of innovation of invasive procedures and devices:Protocol for a systematic review and thematic analysis

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    INTRODUCTION: Surgical innovation has generally occurred in an unstandardised manner. This has led to unnecessary exposure of patients to harm, research waste and inadequate evidence. The IDEAL (Idea, Development, Exploration, Assessment, Long-term follow-up) Collaboration provided a set of recommendations for evaluating surgical innovations based on their stage of innovation. Despite further refinements and guidance, adoption of the IDEAL recommendations has been slow; an important reason may be that determining the stage of innovation is often difficult. To facilitate evaluation of surgical innovations, there is a need for a detailed insight into what stage of innovation means, and how it can be determined. The aim of this study is to understand the concept of stage of innovation as reported in the literature. METHODS AND ANALYSIS: A systematic review is being conducted. Ovid MEDLINE and Embase databases were searched from their inception until July 2021 using an iteratively developed strategy based on the concepts of stage of innovation, invasive procedures or devices and guidance. Articles were included if they described an approach to evaluating surgical innovations in stages, described a method for determining stage of innovation, described indicators of stage of innovation, defined stages or described potential sources of stage-related information. Conference abstracts and non-English language articles were excluded. Other articles were detected from citations within included articles and suggestions from experts in surgical innovation. Data will be extracted regarding approaches to evaluating surgical innovations, methods for determining stage of innovation, indicators of stage of innovation, definitions of stages and potential sources of stage-related information. A thematic analysis will be conducted, and findings summarised in a narrative report. ETHICS AND DISSEMINATION: Ethical approval will not be required. This systematic review will be published in a peer-reviewed journal and presented at appropriate conferences. PROSPERO REGISTRATION NUMBER: CRD42021270812

    How do pilot and feasibility studies inform randomised placebo-controlled trials in surgery? : A systematic review

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    © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.Peer reviewedPublisher PD

    Patient information leaflets for placebo-controlled surgical trials : a review of current practice and recommendations for developers

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    Contributions Sian Cousin: methodology; formal analysis; writing—original draft; writing—review and editing; visualisation. Marc Huttman: data collection, review and editing. Natalie Blencowe: conceptualisation; methodology; formal analysis; writing—original draft; writing—review and editing; visualisation. Carmen Tsang: data collection, review and editing. Daisy Elliott: formal analysis, review and editing. Jane Blazeby: review and editing. David Beard: conceptualisation, review and editing. Marion Campbell: conceptualisation, review and editing. Katie Gillies: conceptualisation; methodology; formal analysis; writing—original draft; writing—review and editing; visualisation.Peer reviewe
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