COPe-support - a multi-component digital intervention for family carers for people affected by psychosis: study protocol for a randomized controlled trial.

BACKGROUND: Psychosis often causes significant distress and impacts not only in the individuals, but also those close to them. Many relatives and friends ('carers') provide long-term support and need resources to assist them. We have co-produced a digital mental health intervention called COPe-support (Carers fOr People with Psychosis e-support) to provide carers with flexible access to high quality psychoeducation and interactive support from experts and peers. This study evaluates the effectiveness of COPe-support to promote mental wellbeing and caregiving experiences in carers. METHODS: This study is a single-blind, parallel arm, individually randomized controlled trial (RCT) comparing COPe-support, with attention control. Both groups continue to receive usual care. COPe-support provides interactive web-based psychoeducation on psychosis-related issues, wellbeing-promotion and network support through forums. The attention-control is a non-interactive online information resource pack. Carers living in England are eligible if they provide at least weekly support to a family member or close friend affected by psychosis, and use internet communication (including emails) daily. All trial procedures are run online, including collection of outcome measurements which participants will directly input into our secure platform. Following baseline assessment, a web-based randomization system will be used to allocate 360 carers to either arm. Participants have unlimited access to the allocated condition for 40 weeks. Data collection is at three time points (10, 20, and 40 weeks after randomization). Analyses will be conducted by trial statisticians blinded to allocation. The primary outcome is mental wellbeing measured by Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), at 20 weeks. As well as an intention-to-treat analysis, a complier average causal effect (CACE) analysis will be conducted to estimate the intervention effect in participants who have accessed COPe-support content twice or more. The secondary objectives and analysis will examine other health and caregiving-related outcomes and explore mechanisms. In a process evaluation, we will interview 20% of the intervention arm participants regarding the acceptability of COPe-support. We will explore in detail participants' usage patterns. DISCUSSION: The results of this trial will provide valuable information about the effectiveness of COPe-support in promoting wellbeing and caregiving experiences in carers. TRIAL REGISTRATION: The RCT is registered with the Current Controlled Trials registration (ISRCTN 89563420, registration date: 02/03/2018)

Virtual patients designed for training against medical error: Exploring the impact of decision-making on learner motivation.

OBJECTIVES: Medical error is a significant cause of patient harms in clinical practice, but education and training are recognised as having a key role in minimising their incidence. The use of virtual patient (VP) activities targeting training in medical error allows learners to practice patient management in a safe environment. The inclusion of branched decision-making elements in the activities has the potential to drive additional generative cognitive processing and improved learning outcomes, but the increased cognitive load on learning risks negatively affecting learner motivation. The aim of this study is to better understand the impact that the inclusion of decision-making and inducing errors within the VP activities has on learner motivation. METHODS: Using a repeated study design, over a period of six weeks we provided undergraduate medical students at six institutions in three countries with a series of six VPs written around errors in paediatric practice. Participants were divided into two groups and received either linearly structured VPs or ones that incorporated branched decision-making elements. Having completed all the VPs, each participant was asked to complete a survey designed to assess their motivation and learning strategies. RESULTS: Our analysis showed that in general, there was no significant difference in learner motivation between those receiving the linear VPs and those who received branched decision-making VPs. The same results were generally reflected across all six institutions. CONCLUSIONS: The findings demonstrated that the inclusion of decision-making elements did not make a significant difference to undergraduate medical students' motivation, perceived self-efficacy or adopted learning strategies. The length of the intervention was sufficient for learners to overcome any increased cognitive load associated with branched decision-making elements being included in VPs. Further work is required to establish any immediate impact within periods shorter than the length of our study or upon achieved learning outcomes

The Development of a Virtual World Problem-Based Learning Tutorial and Comparison With Interactive Text-Based Tutorials

Collaborative learning through case-based or problem-based learning (PBL) scenarios is an excellent way to acquire and develop workplace knowledge associated with specific competencies. At St George's, University of London we developed an interactive online form of decision-based PBL (D-PBL) for our undergraduate medical course using web-based virtual patients (VPs). This method of delivery allowed students to consider options for clinical management, to take decisions and to explore the consequences of their chosen actions. Students had identified this as a more engaging type of learning activity compared to conventional paper-based/linear PBL and demonstrated improved exam performance in controlled trials. We explored the use of Second Life (SL), a virtual world and immersive 3D environment, as a tool to provide greater realism than our interactive image and text-based D-PBL patient cases. Eighteen separate tutorial groups were provided with their own experience of the same patient scenario in separate locations within the virtual world. The study found that whilst a minority of students reported that the Second Life experience felt more realistic, most did not. Students favored the simpler interaction of the web-based VPs, which already provided them with the essential learning needed for practice. This was in part due to the time proximity to exams and the extra effort required to learn the virtual world interface. Nevertheless, this study points the way towards a scalable process for running separate PBL sessions in 3D environments

Mental health and caregiving experiences of family carers supporting people with psychosis.

AIMS: Family carers supporting an individual with psychosis often experience poorer mental health, however, little is known about specific risk factors among these carers. We investigated the associations between demographic, caregiving characteristics and mental health outcomes in family carers supporting an individual with psychosis and compared carers' outcomes with general population norms. METHODS: We analysed baseline data from the COPe-support randomised controlled trial of online psychoeducation and peer support for adult carers supporting an individual with psychosis between 2018 and 2020. We collected carers' demographic and health outcome data, including wellbeing using Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS as primary outcome), quality of life using EQ-5D-5L and caregiving experience assessed with Experience of Caregiving Inventory. We tested associations between carers' demographic and caregiving characteristics for each outcome in turn and meta-analysed carers' WEMWBS and EQ-5D-5L with Health Survey England (HSE) general population data from 2016 and 2017, respectively. RESULTS: The 407 carers of people with psychosis had a mean WEMWBS score of 42.2 (s.d. 9.21) and their overall weighted pooled WEMWBS score was 7.3 (95% confidence interval (CI) -8.6 to -6.0, p < 0.01) lower than the HSE general population sample, indicating carers have poorer mental wellbeing by more than double the minimum clinically important difference of 3 points on WEMWBS. Among all caring relationships, partners had poorer wellbeing compared to parents with lower WEMWBS score (-6.8, -16.9 to 3.3, p = 0.03). Single carers had significantly poorer wellbeing (-3.6, -5.6 to -1.5, p < 0.01) and a more negative caregiving experience than those who were cohabiting. Spending more than 35 h per week caregiving increased carers' negative experience significantly (p = 0.01). CONCLUSION: Carers of people with psychosis have poorer mental health than non-carers. Partners, lone carers and those spending more than 35 h per week on caring were found to be most at risk of poor mental health. Based on the results, we advocate that the details of carers for individuals with psychosis should be added to the existing carers or severe mental illness registers at all general practitioner surgeries and for their wellbeing screened routinely. Future large-scale prospective studies are needed to develop a predictive model to determine risk factors, hence to aid early identification of carers' support needs. Such understandings are also useful to inform tailored intervention development

Elective cancer surgery in COVID-19-free surgical pathways during the SARS-CoV-2 pandemic: An international, multicenter, comparative cohort study

PURPOSE As cancer surgery restarts after the first COVID-19 wave, health care providers urgently require data to determine where elective surgery is best performed. This study aimed to determine whether COVID-19–free surgical pathways were associated with lower postoperative pulmonary complication rates compared with hospitals with no defined pathway. PATIENTS AND METHODS This international, multicenter cohort study included patients who underwent elective surgery for 10 solid cancer types without preoperative suspicion of SARS-CoV-2. Participating hospitals included patients from local emergence of SARS-CoV-2 until April 19, 2020. At the time of surgery, hospitals were defined as having a COVID-19–free surgical pathway (complete segregation of the operating theater, critical care, and inpatient ward areas) or no defined pathway (incomplete or no segregation, areas shared with patients with COVID-19). The primary outcome was 30-day postoperative pulmonary complications (pneumonia, acute respiratory distress syndrome, unexpected ventilation). RESULTS Of 9,171 patients from 447 hospitals in 55 countries, 2,481 were operated on in COVID-19–free surgical pathways. Patients who underwent surgery within COVID-19–free surgical pathways were younger with fewer comorbidities than those in hospitals with no defined pathway but with similar proportions of major surgery. After adjustment, pulmonary complication rates were lower with COVID-19–free surgical pathways (2.2% v 4.9%; adjusted odds ratio [aOR], 0.62; 95% CI, 0.44 to 0.86). This was consistent in sensitivity analyses for low-risk patients (American Society of Anesthesiologists grade 1/2), propensity score–matched models, and patients with negative SARS-CoV-2 preoperative tests. The postoperative SARS-CoV-2 infection rate was also lower in COVID-19–free surgical pathways (2.1% v 3.6%; aOR, 0.53; 95% CI, 0.36 to 0.76). CONCLUSION Within available resources, dedicated COVID-19–free surgical pathways should be established to provide safe elective cancer surgery during current and before future SARS-CoV-2 outbreaks

Elective Cancer Surgery in COVID-19-Free Surgical Pathways During the SARS-CoV-2 Pandemic: An International, Multicenter, Comparative Cohort Study.

PURPOSE: As cancer surgery restarts after the first COVID-19 wave, health care providers urgently require data to determine where elective surgery is best performed. This study aimed to determine whether COVID-19-free surgical pathways were associated with lower postoperative pulmonary complication rates compared with hospitals with no defined pathway. PATIENTS AND METHODS: This international, multicenter cohort study included patients who underwent elective surgery for 10 solid cancer types without preoperative suspicion of SARS-CoV-2. Participating hospitals included patients from local emergence of SARS-CoV-2 until April 19, 2020. At the time of surgery, hospitals were defined as having a COVID-19-free surgical pathway (complete segregation of the operating theater, critical care, and inpatient ward areas) or no defined pathway (incomplete or no segregation, areas shared with patients with COVID-19). The primary outcome was 30-day postoperative pulmonary complications (pneumonia, acute respiratory distress syndrome, unexpected ventilation). RESULTS: Of 9,171 patients from 447 hospitals in 55 countries, 2,481 were operated on in COVID-19-free surgical pathways. Patients who underwent surgery within COVID-19-free surgical pathways were younger with fewer comorbidities than those in hospitals with no defined pathway but with similar proportions of major surgery. After adjustment, pulmonary complication rates were lower with COVID-19-free surgical pathways (2.2% v 4.9%; adjusted odds ratio [aOR], 0.62; 95% CI, 0.44 to 0.86). This was consistent in sensitivity analyses for low-risk patients (American Society of Anesthesiologists grade 1/2), propensity score-matched models, and patients with negative SARS-CoV-2 preoperative tests. The postoperative SARS-CoV-2 infection rate was also lower in COVID-19-free surgical pathways (2.1% v 3.6%; aOR, 0.53; 95% CI, 0.36 to 0.76). CONCLUSION: Within available resources, dedicated COVID-19-free surgical pathways should be established to provide safe elective cancer surgery during current and before future SARS-CoV-2 outbreaks

Perceived acceptability and experiences of a digital psychoeducation and peer support intervention (COPe-support): interview study with carers supporting individuals with psychosis (Preprint)

Background: Digital mental health interventions offer a novel, accessible and self-paced approach to care delivery to family carers, i.e., relatives and close friends who support a loved one with psychosis. We co-produced COPe-support, a psychoeducational intervention delivered via an enriched online environment with network support from professionals and peers. In addition to rigorous investigation of the effectiveness of COPe-support on carers’ wellbeing and mental health outcomes, it is imperative to understand carers’ experiences in using the digital intervention and its associated online implementation and facilitation strategies. Objective: This study aimed to explore (1) carers’ experience and perceived acceptability of COPe-support and its different components, and (2) how they found engagement with COPe-support affected their own wellbeing and caregiving. Methods: We conducted a qualitative study, individually interviewing 35 carers after their use of COPe-support for 8 months through an online randomised controlled trial across England. A semi-structured guide with open-ended questions was used to explore carers’ experience and perceived acceptability of the intervention, and their ideas to improve the provision. All interviews were conducted remotely through mobile phone or internet communication media, audio-recorded, and transcribed verbatim. We used the thematic analysis framework approach to analyse the data. Results: Three key themes were identified: (i) remote, flexible and personalised, (ii) impacts on well-being and outlook on caregiving, and (iii) future implementation and integration with existing services. Overall, carers identified COPe-support as a helpful resource for themselves and for their caregiving role. Participants’ experiences, usage and activity on COPe-support varied a great deal and differed amongst carers of various ages and level of computer literacy. Conclusions: Carers found COPe-support a flexible source of knowledge and support from professionals and peers which they can personalise to suit their own needs and convenience. Participants described gaining self-confidence, hope, and a sense of connectivity with others in a similar situation which helped ameliorate isolation and perceived stigma. Most importantly, COPe-support promoted self-care in the carers themselves. While nearly all participants had a positive experience with COPe-support and supported its wider implementation as a beneficial adjunctive support resource for carers in the future, they suggested some improvements. These include having more graphics and visual-audio content materials, improving the navigation and building in more interactional and customisation options to suit various users’ style (e.g. emoji reactions, live online chat, opting in-and-out of updates and choosing frequency of reminders). Any future scale-up of such an intervention should also consider factors pertinent to reaching more carers and integrating the digital resource with other conventional services. Clinical Trial: Current Controlled Trials registration ISRCTN 89563420

Pharmacological, behavioural and mechanistic analysis of HIV-1 gp120 induced painful neuropathy

A painful neuropathy is frequently observed in people living with human immunodeficiency virus type 1 (HIV-1). The HIV coat protein, glycoprotein 120 (gp120), implicated in the pathogenesis of neurological disorders associated with HIV, is capable of initiating neurotoxic cascades via an interaction with the CXCR4 and/or CCR5 chemokine receptors, which may underlie the pathogenesis of HIV-associated peripheral neuropathic pain. In order to elucidate the mechanisms underlying HIV-induced painful peripheral neuropathy, we have characterised pathological events in the peripheral and central nervous system following application of HIV-1 gp120 to the rat sciatic nerve. Perineural HIV-1 gp120 treatment induced a persistent mechanical hypersensitivity (44% decrease from baseline), but no alterations in sensitivity to thermal or cold stimuli, and thigmotactic (anxiety-like) behaviour in the open field. The mechanical hypersensitivity was sensitive to systemic treatment with gabapentin, morphine and the cannabinoid WIN 55,212-2, but not with amitriptyline. Immunohistochemical studies reveal: decreased intraepidermal nerve fibre density, macrophage infiltration into the peripheral nerve at the site of perineural HIV-1 gp120; changes in sensory neuron phenotype including expression of activating transcription factor 3 (ATF3) in 27% of cells, caspase-3 in 25% of cells, neuropeptide Y (NPY) in 12% of cells and galanin in 13% of cells and a spinal gliosis. These novel findings suggest that this model is not only useful for the elucidation of mechanisms underlying HIV-1-related peripheral neuropathy but may prove useful for preclinical assessment of drugs for the treatment of HIV-1 related peripheral neuropathic pain