The Smiley Faces task and how it can help teach some fundamentals for good clinical trials

Background: Many factors need to be considered when designing a clinical trial. Although structures such as PICOT (Population, Intervention, Comparator, Outcome, Timeline) are helpful, people with little or no prior knowledge can find designing and implementing a trial to be overly complicated. We developed a simple exercise to illustrate key features of trials: the Smiley Faces task.Aim: We describe how the Smiley Faces task can demonstrate the importance of good planning of trials and highlight pitfalls.Method and Results: The Smiley Faces task is centred on the simple, intuitive task to “draw a smiley face”. It requires no existing knowledge about trials or research generally, but can be used to highlight key features of a trial; such as formulating the research question; planning for coding, collection and analysis of data; handling of missing data and drawing of conclusions. We present insights from conducting the exercise dozens of times and collecting hundreds of smiley face drawings in a range of educational settings.Conclusion: The simplicity and accessibility of the task makes it relatively easy to demonstrate key points for careful planning of clinical trials. The approach is generalizable and applicable to researchers and teachers in a variety of medical settings

Signposts to Change by and for the rare disease community

A rare disease is defined as occurring in <1 in 2,000 people, but cumulatively rare diseases are common with one in 17 people in the UK being affected by a rare condition. The problems encountered because of the low number of instances of rare diseases are vast and need solutions. Thus improving communication mechanisms both within and around the healthcare system is of vital importance to individuals living and working with rare diseases.Surveys amongst people affected by and working with a rare disease have been, and will continue to be, carried out to establish what communication for them is like within the healthcare system. The DELPHI model will then be used to identify the priorities for improving communication for people with rare disease in Northern Ireland. From the survey data there were 60 priorities identified which have been grouped under 4 headings: Sources of Information, Medical Care, Rare Disease Community, and Public Awareness.There is a huge amount of progress which needs to be made in order to improve how someone with a rare disease receives information, treatment, and ultimately holistic care to help them deal with the life-changing event of discovering that they have a rare diseas

Heart Rate Variability Biofeedback to Reduce Anxiety in Autism Spectrum Disorder -a mini review

There is a reported high prevalence of anxiety in people with autism spectrum disorder. This mini review appraises existing research investigating heart rate variability biofeedback to help manage symptoms of anxiety in people with autism spectrum disorder. A thorough search of electronic databases was conducted to find relevant literature. Consultation with experts and a librarian helped develop search terms following the PICO framework. Five databases were searched, and screening was undertaken using Covidence software, with the process outlined in a PRISMA flowchart. The latest review showed positive short-term effects but there is a need for long-term follow-up. Future investigations should consider device type, training settings, and control interventions. Accurate heart rate variability assessment independent of biofeedback devices is crucial. Additional measures like cortisol assessment and user feedback are recommended for comprehensive evaluation. The findings highlight progress in the evidence base and offer insight to future directions

Completely-Positive Non-Markovian Decoherence

We propose an effective Hamiltonian approach to investigate decoherence of a quantum system in a non-Markovian reservoir, naturally imposing the complete positivity on the reduced dynamics of the system. The formalism is based on the notion of an effective reservoir, i.e., certain collective degrees of freedom in the reservoir that are responsible for the decoherence. As examples for completely positive decoherence, we present three typical decoherence processes for a qubit such as dephasing, depolarizing, and amplitude-damping. The effects of the non-Markovian decoherence are compared to the Markovian decoherence.Comment: 8 pages, 1 figur

Implementing an arts-based intervention for patients with end-stage kidney disease whilst receiving haemodialysis: A feasibility study protocol

Abstract Background End-stage kidney disease is a life-changing illness. Many patients require haemodialysis, a treatment that impacts profoundly on quality of life and mental health. Arts-based interventions have been used in other healthcare settings to improve mental health and quality of life; therefore, they may help address the impact of haemodialysis by improving these outcomes. However, there is a lack of evidence assessing their effectiveness in this population and few randomised controlled trials (RCTs) evaluating the effectiveness of complex arts-based interventions. Methods The aims of this study are to establish the feasibility of a cluster RCT of an arts-based intervention for patients with end-stage kidney disease whilst receiving haemodialysis through a cluster randomised pilot study, explore the acceptability of the intervention with a process evaluation and explore the feasibility of an economic evaluation. The study will have three phases. The first phase consists of a cluster randomised pilot study to establish recruitment, participation and retention rates. This will involve the recruitment of 30 participants who will be randomly allocated through cluster randomisation according to shift pattern to experimental and control group. The second phase will be a qualitative process evaluation to establish the acceptability of the intervention within a clinical setting. This will involve semi-structured interviews with 13 patients and three focus groups with healthcare professionals. The third phase will be a feasibility economic evaluation to establish the best methods for data collection within a future cluster RCT. Discussion Arts-based interventions have been shown to improve quality of life in healthcare settings, but there is a lack of evidence evaluating arts-based interventions for patients receiving haemodialysis. This study aims to assess the feasibility of a future cluster RCT assessing the impact of an arts-based intervention on the wellbeing and mental health of patients receiving haemodialysis and identify the key factors leading to successful implementation. The hope is this study will inform a trial that can influence future healthcare policy by providing robust evidence for arts-based interventions within the haemodialysis setting. Trial registration The trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496

It’s all in whom you know (as well as what you know). Using network analysis and health professionals own knowledge for recruitment.

Peer reviewedPublisher PD

Heart rate variability biofeedback to reduce anxiety in autism spectrum disorder – a mini review

There is a reported high prevalence of anxiety in people with autism spectrum disorder. This mini review appraises existing research investigating heart rate variability biofeedback to help manage symptoms of anxiety in people with autism spectrum disorder. A thorough search of electronic databases was conducted to find relevant literature. Consultation with experts and a librarian helped develop search terms following the PICO framework. Five databases were searched, and screening was undertaken using Covidence software, with the process outlined in a PRISMA flowchart. The latest review showed positive short-term effects but there is a need for long-term follow-up. Future investigations should consider device type, training settings, and control interventions. Accurate heart rate variability assessment independent of biofeedback devices is crucial. Additional measures like cortisol assessment and user feedback are recommended for comprehensive evaluation. The findings highlight progress in the evidence base and offer insight to future directions

Communication strategies for rare cancers : A systematic review protocol

Funding CB is a summer student being funded by the Centre for Public Health, Queen’s University Belfast. Availability of data and materials Data was obtained from peer-reviewed publications which are available in the public domain and may be subject to copyright. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.Peer reviewedPublisher PD

Feasibility of home-based exercise training during adjuvant treatment for metastatic castrate-resistant prostate cancer patients treated with an androgen receptor pathway inhibitor (EXACT)

BackgroundExercise is an effective adjuvant therapy that can alleviate treatment-related toxicities for men with prostate cancer (PC). However, the feasibility of delivering exercise training to men with advanced disease and the wider impact on clinical outcomes remain unknown. The purpose of the EXACT trial was to determine the feasibility and effects of home-based exercise training in men with metastatic castrate-resistant prostate cancer (mCRPC). MethodsPatients with mCRPC receiving ADT + an androgen receptor pathway inhibitor (ARPI) were prescribed 12 weeks of home-based, remotely monitored, moderate intensity, aerobic and resistance exercise. Feasibility was assessed using recruitment, retention and adherence rates. Safety and adverse events were monitored throughout, with functional and patient-reported outcomes captured at baseline, post-intervention and at 3-month follow-up. ResultsFrom the 117 screened, 49 were deemed eligible and approached, with 30 patients providing informed consent (61% recruitment rate). Of those who consented, 28 patients completed baseline assessments, with 24 patients completing the intervention and 22 completing follow-up (retention rates: 86% and 79% respectively). Task completion was excellent throughout, with no intervention-related adverse events recorded. Self-reported adherence to the overall intervention was 82%. Exercise training decreased mean body mass (−1.5%), improved functional fitness (> 10%) and improved several patient-reported outcomes including clinically meaningful changes in fatigue (p = 0.042), FACT-G (p = 0.054) and FACT-P (p = 0.083), all with moderate effect sizes. ConclusionHome-based exercise training, with weekly remote monitoring, was feasible and safe for men with mCRPC being treated with an ARPI. Given that treatment-related toxicities accumulate throughout the course of treatment, and as a result, negatively impact functional fitness and health-related quality of life (HRQoL), it was positive that exercise training improved or prevented a decline in these clinically important variables and could better equip patients for future treatment. Collectively, these preliminary feasibility findings support the need for a definitive, larger RCT, which downstream may lead to the inclusion of home-based exercise training as part of adjuvant care for mCRPC