A randomised feasibility study of serial magnetic resonance imaging to reduce treatment times in Charcot neuroarthropathy in people with diabetes (CADOM): A protocol

Background Charcot neuroarthropathy is a complication of peripheral neuropathy associated with diabetes which most frequently affects the lower limb. It can cause fractures and dislocations within the foot, which may progress to deformity and ulceration. Recommended treatment is immobilisation and offloading, with a below knee non-removable cast or boot. Duration of treatment varies from six months to more than one year. Small observational studies suggest that repeated assessment with Magnetic Resonance Imaging improves decision making about when to stop treatment, but this has not been tested in clinical trials. This study aims to explore the feasibility of using serial Magnetic Resonance Imaging without contrast in the monitoring of Charcot neuroarthropathy to reduce duration of immobilisation of the foot. A nested qualitative study aims to explore participants’ lived experience of Charcot neuroarthropathy and of taking part in the feasibility study. Methods We will undertake a two arm, open study, and randomise 60 people with a suspected or confirmed diagnosis of Charcot neuroarthropathy from five NHS, secondary care multidisciplinary Diabetic Foot Clinics across England. Participants will be randomised 1:1 to receive Magnetic Resonance Imaging at baseline and remission up to 12 months, with repeated foot temperature measurements and x-rays (standard care plus), or standard care plus with additional three-monthly Magnetic Resonance Imaging until remission up to 12 months (intervention). Time to confirmed remission of Charcot neuroarthropathy with off-loading treatment (days) and its variance will be used to inform sample size in a full-scale trial. We will look for opportunities to improve the protocols for monitoring techniques and the clinical, patient centred, and health economic measures used in a future study. For the nested qualitative study, we will invite a purposive sample of 10-14 people able to offer maximally varying experiences from the feasibility study to take part in semi-structured interviews to be analysed using thematic analysis. Discussion The study will inform the decision whether to proceed to a full-scale trial. It will also allow deeper understanding of the lived experience of Charcot neuroarthropathy, and factors that contribute to engagement in management and contribute to the development of more effective patient centred strategies. Trial registration ISRCTN, ISRCTN, 74101606. Registered on 6 November 2017, http://www.isrctn.com/ISRCTN74101606?q=CADom&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-searc

Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB)

Background: Despite the high prevalence of mood problems after stroke, evidence on effective interventions particularly for those with aphasia is limited. There is a pressing need to systematically evaluate interventions aiming to improve wellbeing for people with stroke and aphasia. This study aims to evaluate the feasibility of a peer-befriending intervention. Methods/design: SUPERB is a single blind, parallel group feasibility trial of peer befriending for people with aphasia post-stroke and low levels of psychological distress. The trial includes a nested qualitative study and pilot economic evaluation and it compares usual care (n = 30) with usual care + peer befriending (n = 30). Feasibility outcomes include proportion screened who meet criteria, proportion who consent, rate of consent, number of missing/incomplete data on outcome measures, attrition rate at follow-up, potential value of conducting main trial using value of information analysis (economic evaluation), description of usual care, and treatment fidelity of peer befriending. Assessments and outcome measures (mood, wellbeing, communication, and social participation) for participants and significant others will be administered at baseline, with outcome measures re-administered at 4 and 10 months post-randomisation. Peer befrienders will complete outcome measures before training and after they have completed two cycles of befriending. The qualitative study will use semi-structured interviews of purposively sampled participants (n = 20) and significant others (n = 10) from both arms of the trial, and all peer befrienders to explore the acceptability of procedures and experiences of care. The pilot economic evaluation will utilise the European Quality of life measure (EQ-5D-5 L) and a stroke-adapted version of the Client Service Receipt Inventory (CSRI). Discussion: This study will provide information on feasibility outcomes and an initial indication of whether peer befriending is a suitable intervention to explore further in a definitive phase III randomised controlled trial. Trial registration: ClinicalTrials.gov identifier NCT02947776, registered 28th October 2016

Medical student confidence to care for a dying patient and their family: a systematic review

Background: The General Medical Council expects medical graduates to care for dying patients with skill, clinical judgement and compassion. UK surveys continually demonstrate low confidence and increasing distress amongst junior doctors when providing care to the dying. Aim: This systematic review aims to determine what has been evidenced within worldwide literature regarding medical undergraduate confidence to care for dying patients. Design: A systematic electronic search was undertaken. Data extraction included measurements of baseline confidence, associated assessment tools, and details of applied educational interventions. Pre/post-intervention confidence comparisons were made. Factors influencing confidence levels were explored. The review was prospectively registered via PROSPERO (CRD42019119057). Data sources: MEDLINE, CINAHL, EMBASE, ISI Web of Science, ERIC, PsychINFO, British Education Index and Cochrane Review databases were accessed, with no restrictions on publication year. Eligible studies included the terms ‘medical student’, ‘confidence’, and ‘dying’, alongside appropriate MeSH headings. Study quality was assessed using the Mixed Methods Appraisal Tool. Results: Fifteen eligible studies were included, demonstrating a diversity of assessment tools. Student confidence was low in provision of symptom management, family support, and psycho-spiritual support to dying patients. Eight interventional studies demonstrated increased post-interventional confidence. Lack of undergraduate exposure to dying patients and lack of structure within undergraduate palliative care curricula were cited as factors responsible for low confidence. Conclusion: This review clarifies the objective documentation of medical undergraduate confidence to care for the dying. Identifying where teaching fails to prepare graduates for realities in clinical practice will help inform future undergraduate palliative care curriculum planning

Influences on the Uptake of and Engagement With Health and Well-Being Smartphone Apps: Systematic Review

Background: The public health impact of health and well-being digital interventions is dependent upon sufficient real-world uptake and engagement. Uptake is currently largely dependent on popularity indicators (eg, ranking and user ratings on app stores), which may not correspond with effectiveness, and rapid disengagement is common. Therefore, there is an urgent need to identify factors that influence uptake and engagement with health and well-being apps to inform new approaches that promote the effective use of such tools. Objective: This review aimed to understand what is known about influences on the uptake of and engagement with health and well-being smartphone apps among adults. Methods: We conducted a systematic review of quantitative, qualitative, and mixed methods studies. Studies conducted on adults were included if they focused on health and well-being smartphone apps reporting on uptake and engagement behavior. Studies identified through a systematic search in Medical Literature Analysis and Retrieval System Online, or MEDLARS Online (MEDLINE), EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsychINFO, Scopus, Cochrane library databases, DataBase systems and Logic Programming (DBLP), and Association for Computing Machinery (ACM) Digital library were screened, with a proportion screened independently by 2 authors. Data synthesis and interpretation were undertaken using a deductive iterative process. External validity checking was undertaken by an independent researcher. A narrative synthesis of the findings was structured around the components of the capability, opportunity, motivation, behavior change model and the theoretical domains framework (TDF). Results: Of the 7640 identified studies, 41 were included in the review. Factors related to uptake (U), engagement (E), or both (B) were identified. Under capability, the main factors identified were app literacy skills (B), app awareness (U), available user guidance (B), health information (E), statistical information on progress (E), well-designed reminders (E), features to reduce cognitive load (E), and self-monitoring features (E). Availability at low cost (U), positive tone, and personalization (E) were identified as physical opportunity factors, whereas recommendations for health and well-being apps (U), embedded health professional support (E), and social networking (E) possibilities were social opportunity factors. Finally, the motivation factors included positive feedback (E), available rewards (E), goal setting (E), and the perceived utility of the app (E). Conclusions: Across a wide range of populations and behaviors, 26 factors relating to capability, opportunity, and motivation appear to influence the uptake of and engagement with health and well-being smartphone apps. Our recommendations may help app developers, health app portal developers, and policy makers in the optimization of health and well-being apps

Patient-reported outcome measures for chronic obstructive pulmonary disease: the exclusion of people with low literacy skills and learning disabilities

<p>Background: Patient-reported outcome measures (PROMs) are intended to reflect outcomes relevant to patients. They are increasingly used for healthcare quality improvement. To produce valid measures, patients should be involved in the development process but it is unclear whether this usually includes people with low literacy skills or learning disabilities. This potential exclusion raises concerns about whether these groups will be able to use these measures and participate in quality improvement practices.</p> <p>Methods: Taking PROMs for chronic obstructive pulmonary disease (COPD) as an exemplar condition, our review determined the inclusion of people with low literacy skills and learning disabilities in research developing, validating, and using 12 PROMs for COPD patients. The studies included in our review were based on those identified in two existing systematic reviews and our update of this search. Results People with low literacy skills and/or learning disabilities were excluded from the development of PROMs in two ways: explicitly through the participant eligibility criteria and, more commonly, implicitly through recruitment or administration methods that would require high-level reading and cognitive abilities. None of the studies mentioned efforts to include people with low literacy skills or learning disabilities.</p> <p>Conclusion: Our findings suggest that people with low literacy skills or learning disabilities are left out of the development of PROMs. Given that implicit exclusion was most common, researchers and those who administer PROMs may not even be aware of this problem. Without effort to improve inclusion, unequal quality improvement practices may become embedded in the health system.</p&gt

Effectiveness of integrated neurocognitive therapy on cognitive impairment and functional outcome for schizophrenia outpatients

Cognitive impairment is highly prevalent in patients with schizophrenia and schizoaffective disorder. Many interventions have been developed to treat cognitive deficit, since it has a strong impact on functional outcome; however, there are no integrated interventions targeting multiple neuro-and social-cognitive domains with a particular focus on the generalization of the effects of therapy on the functional outcome. Recently, a group of experts has developed a cognitive remediation group therapy approach called Integrated Neurocognitive Therapy (INT), which includes exercises to improve the MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) neuro-and social-cognitive domains. This systematic review and meta-analysis aimed to assess the efficacy of this approach. We conducted a search of PubMed, Scopus, Web of Science, and PsycINFO to select primary studies evaluating INT in schizophrenic and schizoaffective patients. The primary outcomes of the meta-analysis included negative and positive symptoms and global functioning. Two randomized controlled trials met inclusion criteria. A total of 217 participants were included. Based on the results from the Positive and Negative Syndrome Scale (PANSS), a significant pooled effect size was observed for negative symptoms, which demonstrated not only an improvement in the patients treated immediately after therapy but also a permanence of positive results at a 9-12-month follow-up. On the other hand, no significant effect size was observed for positive symptoms. In addition, a significant pooled effect size was found for Global Assessment of Functioning (GAF), which shows how INT's integrated approach has lasting positive implications on patients' functional outcome. We concluded that INT might be an effective treatment for negative symptoms and global functioning in patients with schizophrenia, compared to treatment as usual (TAU)

Namaste Care in nursing care homes with people with advanced dementia: protocol for a feasibility randomised controlled trial

© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ.Introduction Many people living with advanced dementia live and die in nursing care homes. The quality of life, care and dying experienced by these people is variable. Namaste Care is a multisensory programme of care developed for people with advanced dementia. While there is emerging evidence that Namaste Care may be beneficial for people with dementia, there is a need to conduct a feasibility study to establish the optimum way of delivering this complex intervention and whether benefits can be demonstrated in end-of-life care, for individuals and service delivery. The aim of the study is to ascertain the feasibility of conducting a full trial of the Namaste Care intervention. Methods and analysis A feasibility study, comprising a parallel, two-arm, multicentre cluster controlled randomised trial with embedded process and economic evaluation. Nursing care homes (total of eight) who deliver care to those with advanced dementia will be randomly allocated to intervention (delivered at nursing care home level) or control. Three participant groups will be recruited: residents with advanced dementia, informal carers of a participating resident and nursing care home staff. Data will be collected for 6 months. Feasibility objectives concern the recruitment and sampling of nursing homes, residents, informal carers and staff; the selection and timing of primary (quality of dying and quality of life) and secondary clinical outcome measures (person centredness, symptom presence, agitation, quality of life, resource use and costs and residents' activity monitored using actigraphy). Acceptability, fidelity and sustainability of the intervention will be assessed using semistructured interviews with staff and informal carers. Ethics and dissemination This protocol has been approved by NHS Wales Research Ethics Committee 5 (ref: 17/WA0378). Dissemination plans include working with a public involvement panel, through a website (http://www.namastetrial.org.uk), social media, academic and practice conferences and via peer reviewed publications. Trial registration number ISRCTN14948133; Pre-results.Peer reviewe

The Ghent Psychotherapy Study (GPS) on the differential efficacy of supportive-expressive and cognitive behavioral interventions in dependent and self-critical depressive patients : study protocol for a randomized controlled trial

Background: Major depressive disorder is a leading cause of disease burden worldwide, indicating the importance of effective therapies. Outcome studies have shown overall efficacy of different types of psychotherapy across groups, yet large variability within groups. Although patient characteristics are considered crucial in understanding outcome, they have received limited research attention. This trial aims at investigating the interaction between therapeutic approach (pre-structured versus explorative) and the personality style of patients (dependent versus self-critical), which is considered a core underlying dimension of depressive pathology. Methods/design: This study is a pragmatic stratified (dependent and self-critical patients) parallel trial with equal randomization (allocation 1: 1) conducted in Flanders, Belgium. One hundred and four patients will be recruited and randomized to either 16-20 sessions of cognitive behavioral therapy for depression (pre-structured approach) or 16-20 sessions of short-term psychodynamic psychotherapy for depression (explorative approach) conducted by trained psychotherapists in private practices. The primary outcome is the severity of depression as measured by the Hamilton Rating Scale for Depression at completion of therapy. Secondary outcome measures include self-reported depressive and other symptoms, interpersonal functioning, idiosyncratic complaints, and the presence of the diagnosis of depression. Additional measures include biological measures, narrative material (sessions, interviews), and health care costs. Discussion: This trial presents the test of an often-described, yet hardly investigated interaction between important personality dimensions and therapeutic approach in the treatment of depression. Results could inform therapists on how to match psychotherapeutic treatments to specific personality characteristics of their patients

Game of Stones:feasibility randomised controlled trial of how to engage men with obesity in text message and incentive interventions for weight loss

Objectives To examine the acceptability and feasibility of narrative text messages with or without financial incentives to support weight loss for men. Design Individually randomised three-arm feasibility trial with 12 months’ follow-up. Setting Two sites in Scotland with high levels of disadvantage according to Scottish Index for Multiple Deprivation (SIMD). Participants Men with obesity (n=105) recruited through community outreach and general practitioner registers. Interventions Participants randomised to: (A) narrative text messages plus financial incentive for 12 months (short message service (SMS)+I), (B) narrative text messages for 12 months (SMS only), or (C) waiting list control. Outcomes Acceptability and feasibility of recruitment, retention, intervention components and trial procedures assessed by analysing quantitative and qualitative data at 3, 6 and 12 months. Results 105 men were recruited, 60% from more disadvantaged areas (SIMD quintiles 1 or 2). Retention at 12 months was 74%. Fewer SMS+I participants (64%) completed 12-month assessments compared with SMS only (79%) and control (83%). Narrative texts were acceptable to many men, but some reported negative reactions. No evidence emerged that level of disadvantage was related to acceptability of narrative texts. Eleven SMS+I participants (31%) successfully met or partially met weight loss targets. The cost of the incentive per participant was £81.94 (95% CI £34.59 to £129.30). Incentives were acceptable, but improving health was reported as the key motivator for weight loss. All groups lost weight (SMS+I: −2.51 kg (SD=4.94); SMS only: −1.29 kg (SD=5.03); control: −0.86 kg (SD=5.64) at 12 months). Conclusions This three-arm weight management feasibility trial recruited and retained men from across the socioeconomic spectrum, with the majority from areas of disadvantage, was broadly acceptable to most participants and feasible to deliver