A feasibility randomised controlled trial of elaborated Semantic Feature Analysis delivered in the virtual world, EVA Park

Background: Aphasia affects 350,00 people in the UK with negative consequences to a person’s social connectedness and quality of life. Speech and language therapy interventions aim to mitigate these consequences, but more therapies are needed that address the language impairment and its impact on conversations and quality of life. The use of Virtual Reality (VR) is emerging in aphasia rehabilitation with potential for providing ecological validity for language interventions. This study aimed to develop and test the feasibility and acceptability of an intervention, Virtual Elaborated Semantic Feature Analysis (VESFA), that addresses language and conversation through the virtual world, EVA Park. Methods: The intervention was developed through mapping out the research evidence, articulating the underlying theories and a programme model, Public Involvement workshops with key user groups, and a qualitative study to investigate meaningful therapy targets. The intervention was tested in a feasibility randomised controlled trial comparing VESFA + usual care with a usual care control. People with word finding difficulties as a result of chronic aphasia were recruited from the community. Feasibility parameters were the percentage of eligible participants who consented to the trial, the percentage of participants available at follow up, rates of cancelled sessions, rates of missing data, the acceptability of the research procedures to participants and the acceptability of the intervention to the participants. Clinical outcomes provided preliminary findings of the impact on language, communication and quality of life. Results: VESFA is a theory and evidence based intervention. It was found to be feasible against pre-specified feasibility criteria. 91% of eligible participants consented to the trial. 85% of participants were available at follow up. Less than 6% of sessions were cancelled. Participant interviews showed that, despite a testing burden, both the trial protocol and the intervention were acceptable. Preliminary clinical outcomes suggest a future definitive trial of VESFA may show benefit to the retrieval of treated and untreated words and improved quality of life. Discussion: Good feasibility and acceptability outcomes suggest that this treatment would be a good candidate for a definitive trial. Delivery in the virtual world EVA Park provided opportunity for situated conversations. This was valued by participants but not captured by the outcome measures. A future trial could use an alternative measure for conversations. Preliminary findings suggest that the VESFA intervention shows promise to improve outcomes that are not consistently found in word retrieval therapies

Receiving Aphasia Intervention in a Virtual Environment: The Participants’ Perspective

Background: Digital technology is making an increasing contribution to aphasia therapy. However applications of virtual reality are rare. EVA Park is a virtual island developed with and for people with aphasia. It is a multi-user environment, which enables people with aphasia to interact with support workers, therapists and each other. The first study to use EVA Park in aphasia rehabilitation demonstrated significant gains in functional communication. This paper augments the findings of that study, by reporting results from qualitative interviews conducted with the 20 study participants. Aims: This study aimed to determine the views of participants about the intervention that they received in EVA Park, and the impacts of that intervention. Long-term retrospective views were also explored. Methods & Procedures: Participants took part in 1:1, semi-structured interviews two weeks before (Entry) and to weeks after (Exit) the intervention. Questions focussed on activities undertaken by participants, communication, changes since the stroke and uses of technology. Exit interviews additionally explored participants’ views and experiences of EVA Park and any perceived impacts of the intervention. A sub-set of 5 participants was interviewed at least one year later, to explore long term recollections of the EVA Park intervention and any perceived long term impacts. Interview data were transcribed and subject to framework analysis. Outcomes & Results: The thematic framework comprised 10 parent themes and 33 sub-themes. Following ‘affect’, the largest single theme related to EVA Park, with 636 coded references. Comments were overwhelmingly positive. EVA Park intervention was strongly associated with fun and enjoyment. Participants particularly valued their relationship with the support workers who delivered the intervention. The virtual locations and activities in EVA Park were also appreciated, together with the contact with other participants. Perceived impacts related to communication, activity, computer use and confidence. Most participants in the long term interviews described maintained impacts. Conclusions: These interview results indicate that the first intervention delivered in EVA Park was highly acceptable to participants and perceived as beneficial. They augment the findings of our experimental study and suggest that EVA Park could be a valuable addition to the resources available to practising clinician

A Randomised Trial of Social Support Group Intervention for People with Aphasia: A Novel Application of Virtual Reality

About a third of strokes cause aphasia, or language loss, with profound consequences for the person’s social participation and quality of life. These problems may be mitigated by group social support. But this intervention is not available to all individuals. This study investigated whether it is feasible to deliver group social support to people with aphasia via a multi-user, virtual reality platform. It also explored the indicative effects of intervention and the costs. Intervention aimed to promote wellbeing and communicative success. It enabled participants to form new social connections and share experiences of living with aphasia. It comprised 14 sessions delivered over 6 months and was led by community based co-ordinators and volunteers. Feasibility measures comprised: recruitment and retention rates, compliance with intervention and assessment of treatment fidelity. Effects of intervention were explored using a waitlist randomised controlled design, with outcome measures of wellbeing, communication, social connectedness and quality of life. Two intervention groups were randomised to an immediate condition and two were randomised to a delayed condition. The main analysis explored scores on the measures between two time points, between which those in the immediate condition had received intervention, but those in the delayed group had not (yet). A comprehensive approach to economic data collection ensured that all costs of treatment delivery were recorded. Feasibility findings showed that the recruitment target was met (N = 34) and 85.3% (29/34) of participants completed intervention. All groups ran the 14 sessions as planned, and participants attended a mean of 11.4 sessions (s.d. 2.8), which was 81.6% of the intended dose. Fidelity checking showed minimal drift from the manualised intervention. No significant change was observed on any of the outcome measures, although the study was not powered to detect these. Costs varied across the four groups, from £7,483 - £12,562 British Pounds Sterling ($10,972 -$18,419 US dollars), depending on travel costs, the relative contributions of volunteers and the number of hardware loans that were needed. The results suggest that a larger trial of remote group support, using virtual reality, would be merited. However the treatment content and regime, and the selection of outcome measures should be reviewed before conducting the trial

What Conversation Topics are Meaningful to People with Aphasia? A qualitative study

Background Speech and language therapists apply word finding therapies for people with aphasia with good outcomes on treated words but limited evidence of generalisation to untreated words. As generalisation cannot be assumed, there is a need to select words for therapy that are meaningful to people with aphasia. Aims This study sought the views of people with aphasia to inform the stimuli for a word finding in conversation treatment. To this end, the research question was: What conversation topics do people with aphasia find most meaningful to talk about? Methods & Procedures This qualitative study used focus groups to identify meaningful conversation topics across a sample of 12 people with chronic aphasia (two groups of six). Participants were recruited from three community aphasia groups. The focus groups were videoed and transcribed. The transcription was analysed using framework analysis. A consensus decision process was then used by researchers to identify the themes with high agreement. Outcomes & Results Twenty conversation topics were generated. Consensus was that eight topics were meaningful. The three topics rated most meaningful were 1) family and friends, 2) food and drink, and 3) living with aphasia. Two topics reached consensus as not meaningful. Ten topics did not reach consensus. Conclusions The conversation topics, ‘family and friends’, ‘food and drink’ and ‘living with aphasia’ were most meaningful to this sample of people with aphasia. Using therapy stimuli from these conversation topics has the potential to create meaningful treatments

Delivering group support for people with aphasia in a virtual world: experiences of service providers

PURPOSE: This study explored the acceptability to service providers of delivering a novel group support intervention for people with aphasia (PWA) in a virtual world. MATERIALS AND METHODS: The service providers were six group coordinators and 10 volunteers. Fourteen of the service providers participated in a semi-structured qualitative interview and 15 took part in a consensus group discussion. Qualitative interviews were analysed using framework analysis. For consensus group discussions, nominal group rankings were analysed and semantically similar responses were identified. RESULTS: Service providers described the virtual world as a safe space in which to communicate, connect, and experiment. The key barriers were technical, particularly relating to sound and connectivity issues. Service providers suggested a range of improvements to the virtual world and intervention programme. They reported that PWA benefitted from accessing a support group in a virtual world, with opportunities to connect socially and to develop their communication skills. CONCLUSIONS: Service providers found delivery of group support intervention in a virtual world to be acceptable. The use of a bespoke virtual world to deliver group support intervention may enhance the experience and increase its accessibility, enabling more PWA to benefit from this type of intervention.Implications for rehabilitationPeople with aphasia benefit from group support intervention but may find it difficult to access face-to-face groups. Delivery of group support intervention in a virtual world is acceptable to service providers, can enhance the experience and increase accessibility of groups. Technical challenges present potential barriers when delivering group support in a virtual world, relating particularly to sound and connectivity. Potential benefits of this model of delivery, as perceived by service providers, include opportunities to connect socially and to develop communication skills plus specific and strong levels of enjoyment of the virtual context

Analysis of polyethylene wear in plain radiographs: The number of radiographs influences the results

Background and purpose Two-dimensional computerized radiographic techniques are frequently used to measure in vivo polyethylene (PE) wear after total hip arthroplasty (THA), and several variables in the clinical set-up may influence the amount of wear that is measured. We compared the repeatability and concurrent validity of linear PE wear on plain radiographs using the same software but a different number of radiographs

A core outcome set for studies of gestational diabetes mellitus prevention and treatment

AIMS/HYPOTHESIS: The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM). METHODS: We identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised. RESULTS: Our review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth). CONCLUSIONS/INTERPRETATION: This COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies. TRIAL REGISTRATION: This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database: http://www.comet-initiative.org/studies/details/686/

Endocannabinoids Generated by Ca2+ or by Metabotropic Glutamate Receptors Appear to Arise from Different Pools of Diacylglycerol Lipase

The identity and subcellular sources of endocannabinoids (eCBs) will shape their ability to affect synaptic transmission and, ultimately, behavior. Recent discoveries support the conclusion that 2-arachidonoyl glycerol, 2-AG, is the major signaling eCB, however, some important issues remain open. 2-AG can be synthesized by a mechanism that is strictly Ca2+-dependent, and another that is initiated by G-protein coupled receptors (GPCRs) and facilitated by Ca2+. An important question is whether or not the 2-AG in these cases is synthesized by the same pool of diacylglycerol lipase alpha (DAGLα). Using whole-cell voltage-clamp techniques in CA1 pyramidal cells in acute in vitro rat hippocampal slices, we investigated two mechanistically distinct eCB-mediated responses to address this issue. We now report that pharmacological inhibitors of DGLα have quantitatively different effects on eCB-mediated responses triggered by different stimuli, suggesting that functional, and perhaps physical, distinctions among pools of DAGLα exist

Core Outcomes for Colorectal Cancer Surgery: A Consensus Study

Background: Colorectal cancer (CRC) is a major cause of worldwide morbidity and mortality. Surgical treatment is common, and there is a great need to improve the delivery of such care. The gold standard for evaluating surgery is within well-designed randomized controlled trials (RCTs); however, the impact of RCTs is diminished by a lack of coordinated outcome measurement and reporting. A solution to these issues is to develop an agreed standard “core” set of outcomes to be measured in all trials to facilitate cross-study comparisons, meta-analysis, and minimize outcome reporting bias. This study defines a core outcome set for CRC surgery. Methods and Findings: The scope of this COS includes clinical effectiveness trials of surgical interventions for colorectal cancer. Excluded were nonsurgical oncological interventions. Potential outcomes of importance to patients and professionals were identified through systematic literature reviews and patient interviews. All outcomes were transcribed verbatim and categorized into domains by two independent researchers. This informed a questionnaire survey that asked stakeholders (patients and professionals) from United Kingdom CRC centers to rate the importance of each domain. Respondents were resurveyed following group feedback (Delphi methods). Outcomes rated as less important were discarded after each survey round according to predefined criteria, and remaining outcomes were considered at three consensus meetings; two involving international professionals and a separate one with patients. A modified nominal group technique was used to gain the final consensus. Data sources identified 1,216 outcomes of CRC surgery that informed a 91 domain questionnaire. First round questionnaires were returned from 63 out of 81 (78%) centers, including 90 professionals, and 97 out of 267 (35%) patients. Second round response rates were high for all stakeholders (>80%). Analysis of responses lead to 45 and 23 outcome domains being retained after the first and second surveys, respectively. Consensus meetings generated agreement on a 12 domain COS. This constituted five perioperative outcome domains (including anastomotic leak), four quality of life outcome domains (including fecal urgency and incontinence), and three oncological outcome domains (including long-term survival). Conclusion: This study used robust consensus methodology to develop a core outcome set for use in colorectal cancer surgical trials. It is now necessary to validate the use of this set in research practice

Computational toxicology using the OpenTox application programming interface and Bioclipse

BACKGROUND: Toxicity is a complex phenomenon involving the potential adverse effect on a range of biological functions. Predicting toxicity involves using a combination of experimental data (endpoints) and computational methods to generate a set of predictive models. Such models rely strongly on being able to integrate information from many sources. The required integration of biological and chemical information sources requires, however, a common language to express our knowledge ontologically, and interoperating services to build reliable predictive toxicology applications. FINDINGS: This article describes progress in extending the integrative bio- and cheminformatics platform Bioclipse to interoperate with OpenTox, a semantic web framework which supports open data exchange and toxicology model building. The Bioclipse workbench environment enables functionality from OpenTox web services and easy access to OpenTox resources for evaluating toxicity properties of query molecules. Relevant cases and interfaces based on ten neurotoxins are described to demonstrate the capabilities provided to the user. The integration takes advantage of semantic web technologies, thereby providing an open and simplifying communication standard. Additionally, the use of ontologies ensures proper interoperation and reliable integration of toxicity information from both experimental and computational sources. CONCLUSIONS: A novel computational toxicity assessment platform was generated from integration of two open science platforms related to toxicology: Bioclipse, that combines a rich scriptable and graphical workbench environment for integration of diverse sets of information sources, and OpenTox, a platform for interoperable toxicology data and computational services. The combination provides improved reliability and operability for handling large data sets by the use of the Open Standards from the OpenTox Application Programming Interface. This enables simultaneous access to a variety of distributed predictive toxicology databases, and algorithm and model resources, taking advantage of the Bioclipse workbench handling the technical layers