Sensory training system for use at home by people with complex regional pain syndrome in England: Protocol for a proof-of-concept study

Introduction: Complex regional pain syndrome (CRPS) is a disabling and distressing chronic pain condition characterised by a range of sensory, motor, autonomic and trophic symptoms. UK guidelines recommend therapy interventions to help normalise touch perception through self-administered tactile and thermal desensitisation activities. Interventions have been developed, aiming to help individuals broaden their sensory experience, thereby relieving chronic pain. However, therapy-led interventions often experience practical constraints and poor adherence. In response, a sensory training system (STS) device has been designed for unsupervised independent home-use.Methods: This proof-of-concept study aims to explore whether people with CRPS use the device at home for 30 minutes a day for 30 days. Secondary aims are to determine whether the STS device will change tactile acuity and perceived levels of pain intensity, pain interference, sensitivity or feelings towards the affected limb. We will seek to recruit 20 eligible participants. Participants will be asked to measure tactile acuity using a two-point discrimination assessment, complete an online questionnaire before and after use of the device and complete a daily diary. On completion of the 30-day use, participants will be invited to take part in a semi-structured interview to explore their experiences of using the device.Analysis: Pain intensity and pain interference will be scored using the online Assessment Center Scoring Service or using the look-up table in the PROMIS scoring manual. The remaining questionnaire data, including tactile acuity results, and device-use data, including frequency and duration of use, will be analysed using descriptive statistics. Qualitative data will be thematically analysed.Ethics and dissemination: London-Stanmore Research Ethics Committee provided a favourable opinion on 19 April 2021 (ref 21/LO/0200). The NHS Health Research Authority, UK, approved this study on 7 June 2021. Dissemination will include peer-reviewed publications, presentations at conferences, social media and reports to the funder and patient charities

Optimising management of complex regional pain syndrome to improve clinical outcomes throughout the therapy care pathway in England: Protocol for a qualitative interview and observational study with patients and clinicians

Introduction: Complex Regional Pain Syndrome (CRPS) is a disabling and distressing chronic pain condition characterised by a range of sensory, motor, autonomic and trophic symptoms. Guidelines recommend early referral for therapies that promote movement of the painful limb. However, evidence suggests a lack of defined therapy pathways for CRPS. Aims: The current study aims to explore CRPS therapy management in centres of excellence in England, and outside of these settings, to understand what facilitates and hinders best practice. The overall aim is to develop a draft stratified package of care to expedite patient access to optimal CRPS therapy across the management pathway. Methods and Analysis: Semi-structured interviews will be conducted with therapists working in CRPS centres of excellence and with therapists in other settings. Observations of therapy interventions in CRPS centres of excellence and interviews with patients who have received this care, will also help to identify potential key care package components. Interview data will be analysed using thematic analysis, mapped to the Theoretical Domains Framework (TDF), and Intervention Mapping Adapt (IMA) framework. Observations will be described and documented using the TDF headings. Conclusion: A triangulation protocol for qualitative health research will be used to integrate all data. Online stakeholder events will be held using consensus methods to agree a draft package of care for future implementation following further refinement, testing and evaluation. Clinical Trial Registration: The trial was registered with ISRCTN registry on 24 February 2022 (ISRCTN16917807)

A feasibility randomised controlled trial of a fibromyalgia self-management programme in a community setting with a nested qualitative study (FALCON): Study protocol

Background: Fibromyalgia (FM) is a complex long-term condition associated with chronic widespread pain, fatigue, sleep problems, memory and concentration difficulties and irritable bowel syndrome. Current guidelines for the treatment of FM recommend nonpharmacological interventions. The Fibromyalgia Self-Management Programme (FSMP) is a nonpharmacological, multidisciplinary exercise and education group intervention. It aims to provide education and teach core skills, enabling those affected by FM to self-manage. The FSMP is currently codelivered by a multidisciplinary team within a secondary care service. The aim of this feasibility randomised controlled trial (RCT) is to determine the practicality and acceptability of delivering the FSMP in a community setting, informing a future RCT of effectiveness. Methods: The feasibility RCT aims to recruit 70 people with FM. Participants will be randomised to either a community FSMP or control arm. All participants will be asked to complete six patient-reported outcome measures and one health economics questionnaire on three occasions; baseline, 6 weeks (end of the intervention) and 6 months. Between 12 and 16 participants and four therapists delivering the FSMP will be invited to take part in a semi-structured interview to explore their experiences of the FSMP. Patient participants will be purposively selected based upon key characteristics. Analysis: Quantitative data will be analysed descriptively to summarise recruitment and attendance, participant reported outcomes and health economic data. Semi-structured interviews will be transcribed, anonymised and inductively coded. The codes will be grouped into categories and theoretically thematically analysed, comparing the results to existing literature. Trial registration: The trial is registered with ISRCTN registry and was assigned on 29th of April 2020. The registration number is ISRCTN10824225

A multiple criteria decision analysis to establish the use cases and candidate point of care tests to enter into a platform trial of multiple in vitro diagnostic point of care tests in the prehospital environment

BackgroundThere are increasing demands on Emergency Medical Services. More efficient treatment pathways are required to support conveyance decision making and patient referral in prehospital care. Point of Care testing is increasingly available and utilised across the NHS to support optimal ways of working. We aimed to design and conduct a Multiple Criteria Decision Analysis to prioritise in vitro point of care tests and use cases for inclusion in a platform trial of in vitro point of care testing in UK Emergency Medical Services.MethodsWe designed a Multiple Criteria Decision Analysis that included systematic scoping reviews stakeholder recruitment, two stakeholder surveys and two stakeholder workshops to scope the use cases, explore criteria and map use cases, evaluate the criteria and measure the use cases against the criteria.ResultsWe recruited 32 stakeholders. We developed a scoring matrix with 4 criteria for scoring the use cases and 8 criteria for scoring the point of care tests and applied weighting determined from survey results. Use cases were scored by the stakeholders against 4 criteria. The 3 highest scoring use cases were point of care troponin testing in: possible Acute Myocardial Infarction, lactate testing in suspected sepsis and in trauma. We developed the process for scoring the point of care tests to be completed close to a proposed trial to allow for a changes in technology.ConclusionsWe successfully designed a Multiple Criteria Decision Analysis to identify use cases and candidate tests for inclusion in a future platform trial of in vitro point of care testing in UK Emergency Medical Services. We identified 3 use cases for evaluation in a platform trial of in vitro point of care testing: troponin testing in possible acute myocardial infarction, lactate testing in suspected sepsis and lactate testing to identify occult haemorrhage in trauma

Isolation and characterization of cross-reactive human monoclonal antibodies that potently neutralize Australian bat lyssavirus variants and other Phylogroup 1 lyssaviruses

: Australian bat lyssavirus (ABLV) is a rhabdovirus that circulates in four species of pteropid bats (ABLVp) and the yellow-bellied sheath-tailed bat (ABLVs) in mainland Australia. In the three confirmed human cases of ABLV, rabies illness preceded fatality. As with rabies virus (RABV), postexposure prophylaxis (PEP) for potential ABLV infections consists of wound cleansing, administration of the rabies vaccine and injection of rabies immunoglobulin (RIG) proximal to the wound. Despite the efficacy of PEP, the inaccessibility of human RIG (HRIG) in the developing world and the high immunogenicity of equine RIG (ERIG) has led to consideration of human monoclonal antibodies (hmAbs) as a passive immunization option that offers enhanced safety and specificity. Using a recombinant vesicular stomatitis virus (rVSV) expressing the glycoprotein (G) protein of ABLVs and phage display, we identified two hmAbs, A6 and F11, which completely neutralize ABLVs/ABLVp, and RABV at concentrations ranging from 0.39 and 6.25 µg/mL and 0.19 and 0.39 µg/mL respectively. A6 and F11 recognize overlapping epitopes in the lyssavirus G protein, effectively neutralizing phylogroup 1 lyssaviruses, while having little effect on phylogroup 2 and non-grouped diverse lyssaviruses. These results suggest that A6 and F11 could be effective therapeutic and diagnostic tools for phylogroup 1 lyssavirus infections.NIH grant and Center for Global Health Engagement, Uniformed Services University grant.https://www.mdpi.com/journal/virusesdm2022Medical Virolog

Effect of Attached Growth on Treatment Performance in Waste Stabilization Ponds

Waste stabilization ponds (WSPs) rely upon natural biochemical reactions for treatment and are used widely across the world. However, WSPs often fail to meet treatment performance expectations due to insufficient hydraulic performance. Installation of baffles can improve hydraulic performance of WSPs by increasing the mean residence time, reducing dead zones, and short circuiting, thus improving pond treatment performance. Theoretically, baffles with the ability to sustain attached growth will increase the possible attachment area of microorganisms and further contribute to nutrient removal. However, to date there have been no full-scale studies exploring attached growth baffles in WSPs. The main objective of this study was to investigate and quantify the effect of attached growth baffles on WSP treatment performance, specifically in terms of improvements in treatment performance provided by attached biofilm compared with hydraulic improvement. A first-order kinetic model was used to predict biological oxygen demand (BOD) removal efficiency, including suspended and biofilm biomass reactions, to determine whether attached growth or hydraulics had the most influence on performance improvement. At the operational WSP scale, we found that although the presence of attached growth on baffles results in a modest (~0.6%) improvement in treatment performance, the most influential factor for improving treatment was improved hydraulics (~5.3%). In model generalization, the change in biofilm thickness and biofilm area had less effect on treatment in WSPs in higher organic loading scenarios; however, a considerable improvement (~12%) in treatment efficiency could be achieved by doubling the total biofilm area. Overall, this study shows that baffles can not only improve WSP hydraulics but can also be used as a medium for increasing biofilm area to improve WSP biological treatment efficiency

P179 A feasibility randomised controlled trial of a fibromyalgia self-management programme in a community setting with a nested qualitative study

Abstract Background/Aims Fibromyalgia (FM) is a complex long-term condition affecting over 5% of the UK population. FM symptoms include widespread pain, fatigue, sleep problems, stiffness, cognitive dysfunction and psychological distress. The condition is associated with high levels of disability, frequent use of healthcare resources and loss of workdays. Current guidelines for the treatment of FM recommend non-pharmacological interventions, including cognitive behaviour therapy, aerobic exercise, warm water therapy, relaxation, and patient education. A typical patient goal is to develop the knowledge and skills needed to self-manage their condition independently. Our Fibromyalgia Self-Management Programme (FSMP) comprises six 2.5-hour sessions over six consecutive weeks and includes education about fibromyalgia, sleep hygiene, goal setting, pacing, and dietary advice. To date, the FSMP has been co-delivered by a multidisciplinary team within a secondary care service. However, delivery in the community may help improve the accessibility of the programme to people with FM. Therefore, this feasibility study aimed to determine the practicality and acceptability of conducting a future definitive randomised controlled trial (RCT) of the FSMP in a community setting. Methods An exploratory, parallel-arm, one-to-one, RCT design was used. Participants were recruited from general practices across South West England, and the FSMP was co-delivered by physiotherapists and occupational therapists across two community sites. To determine the outcome measures for a future definitive trial, several outcomes were tested. All clinical outcome measures were patient-reported and collected at baseline, six weeks and six months. Semi-structured interviews were conducted with patient participants, occupational therapists and physiotherapists to explore the acceptability and feasibility of delivering the FSMP in a community setting. Results Between April and August 2019, 20 General Practices across two sites in SW England invited 1414 patients with an FM diagnosis to participate in the study. A total of 74 participants were randomised to the FSMP intervention (n = 38) or control arm (n = 36). Attrition from the trial was 42% (31/74) at six months. A large proportion of those randomised to the intervention arm (34%, 13/38) failed to attend any sessions, with six of the 13 formally withdrawing before the intervention commenced. The proportion of missing values was small for each of the outcome measures. For the nested qualitative study, 13 patient participants and four therapists were interviewed. Three overarching themes emerged: (1) barriers and facilitators to attending the FSMP; (2) FSMP content, delivery and supporting documentation; and (3) trial processes. Conclusion It is feasible to recruit people with FM from primary care to participate in an RCT testing the clinical and cost-effectiveness of the FSMP delivered in a community setting. However, improvement in attrition and engagement with the intervention is needed. Disclosure J. Pearson: None. J. Coggins: None. S. Derham: None. J. Russell: None. N. Walsh: None. E. Lenguerrand: Other; Erik Lenguerrand and his institution are receiving funding from Ceramtec to conduct an orthopaedic research project that has no relationship to the study presented here. S. Palmer: None. F. Cramp: None