DIALOR (DIgitAL cOaching for fRailty): protocol for a single-arm mixed-methods feasibility study of a digital health coaching intervention for older people with frailty in primary care.

BACKGROUND: Multidomain interventions in older adults offer the best opportunity to prevent, delay or reverse existing symptoms in the earlier stages of frailty and improve independence but can be costly, and difficult to deliver at scale. However, digital health interventions enable personalised care and empowerment through self-management of long-term conditions, used at any time and when combined with health coaching offer the potential to enhance well-being and facilitate the achievement of health-related goals. We aim to evaluate the feasibility and acceptability of a digital health platform for long-term disease management combined with health coaching for people living with mild-moderate frailty, targeting self-identified goals-activity, nutrition, mood, enhancing social engagement and well-being. METHODS AND ANALYSIS: This is a non-randomised feasibility, single-group, pretest/post-test study, using qualitative and quantitative methods. The digital health coaching intervention (DIALOR-DIgitAL cOaching for fRailty) has been developed for implementation to older adults, aged 65 years or older with mild to moderate frailty and diagnosis of one or more long-term health conditions in the community. Participants will receive 12 weeks of health coaching and have access to a mobile health platform for 6 months. The primary outcome measure is the acceptability and feasibility of DIALOR along with a range of secondary outcome measures (including frailty, functioning measures, quality of life, social engagement, diet quality and self-reported indicators) collected at baseline and at 6 months. The findings will inform whether a wider effectiveness trial is feasible and if so, how it should be designed. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Southeast Scotland Research Ethics Committee 02 (reference: 22/SS/0064). Research findings will be disseminated in a range of different ways to engage different audiences, including publishing in open-access peer-reviewed journals, conference presentations, social media, dissemination workshop with patients, carers, and healthcare professionals and on institution websites.

Case management for integrated care of older people with frailty in community settings.

BACKGROUND: Ageing populations globally have contributed to increasing numbers of people living with frailty, which has significant implications for use of health and care services and costs. The British Geriatrics Society defines frailty as "a distinctive health state related to the ageing process in which multiple body systems gradually lose their inbuilt reserves". This leads to an increased susceptibility to adverse outcomes, such as reduced physical function, poorer quality of life, hospital admissions, and mortality. Case management interventions delivered in community settings are led by a health or social care professional, supported by a multidisciplinary team, and focus on the planning, provision, and co-ordination of care to meet the needs of the individual. Case management is one model of integrated care that has gained traction with policymakers to improve outcomes for populations at high risk of decline in health and well-being. These populations include older people living with frailty, who commonly have complex healthcare and social care needs but can experience poorly co-ordinated care due to fragmented care systems. OBJECTIVES: To assess the effects of case management for integrated care of older people living with frailty compared with usual care. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL, Health Systems Evidence, and PDQ Evidence and databases from inception to 23 September 2022. We also searched clinical registries and relevant grey literature databases, checked references of included trials and relevant systematic reviews, conducted citation searching of included trials, and contacted topic experts. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared case management with standard care in community-dwelling people aged 65 years and older living with frailty. DATA COLLECTION AND ANALYSIS: We followed standard methodological procedures recommended by Cochrane and the Effective Practice and Organisation of Care Group. We used the GRADE approach to assess the certainty of the evidence. MAIN RESULTS: We included 20 trials (11,860 participants), all of which took place in high-income countries. Case management interventions in the included trials varied in terms of organisation, delivery, setting, and care providers involved. Most trials included a variety of healthcare and social care professionals, including nurse practitioners, allied healthcare professionals, social workers, geriatricians, physicians, psychologists, and clinical pharmacists. In nine trials, the case management intervention was delivered by nurses only. Follow-up ranged from three to 36 months. We judged most trials at unclear risk of selection and performance bias; this consideration, together with indirectness, justified downgrading the certainty of the evidence to low or moderate. Case management compared to standard care may result in little or no difference in the following outcomes. • Mortality at 12 months' follow-up (7.0% in the intervention group versus 7.5% in the control group; risk ratio (RR) 0.98, 95% confidence interval (CI) 0.84 to 1.15; I2 = 11%; 14 trials, 9924 participants; low-certainty evidence) • Change in place of residence to a nursing home at 12 months' follow-up (9.9% in the intervention group versus 13.4% in the control group; RR 0.73, 95% CI 0.53 to 1.01; I2 = 0%; 4 trials, 1108 participants; low-certainty evidence) • Quality of life at three to 24 months' follow-up (results not pooled; mean differences (MDs) ranged from -6.32 points (95% CI -11.04 to -1.59) to 6.1 points (95% CI -3.92 to 16.12) when reported; 11 trials, 9284 participants; low-certainty evidence) • Serious adverse effects at 12 to 24 months' follow-up (results not pooled; 2 trials, 592 participants; low-certainty evidence) • Change in physical function at three to 24 months' follow-up (results not pooled; MDs ranged from -0.12 points (95% CI -0.93 to 0.68) to 3.4 points (95% CI -2.35 to 9.15) when reported; 16 trials, 10,652 participants; low-certainty evidence) Case management compared to standard care probably results in little or no difference in the following outcomes. • Healthcare utilisation in terms of hospital admission at 12 months' follow-up (32.7% in the intervention group versus 36.0% in the control group; RR 0.91, 95% CI 0.79 to 1.05; I2 = 43%; 6 trials, 2424 participants; moderate-certainty evidence) • Change in costs at six to 36 months' follow-up (results not pooled; 14 trials, 8486 participants; moderate-certainty evidence), which usually included healthcare service costs, intervention costs, and other costs such as informal care. AUTHORS' CONCLUSIONS: We found uncertain evidence regarding whether case management for integrated care of older people with frailty in community settings, compared to standard care, improved patient and service outcomes or reduced costs. There is a need for further research to develop a clear taxonomy of intervention components, to determine the active ingredients that work in case management interventions, and identify how such interventions benefit some people and not others.

Stemming the 'Leaky Pipeline': an investigation of the relationship between work-family conflict and women's career progression in academic medicine.

BACKGROUND: Even though women outnumber men enrolled in medical school, making up 59% of entrants in the UK, they are significantly under-represented in academic medicine and senior positions. In the UK, 28.6% of academics overall are women. In the USA, while 51% of instructors are women, only 20% make it through the 'leaky pipeline' to become professors. One attributable factor is work-family conflict. The purpose of this study is to gain a deeper understanding of the relationship between work-family conflict and women's career progression in academic medicine, and to provide a model to inform and change perceptions and practice in order to improve the 'leaky pipeline'. METHODS: A systematic literature search was performed to identify qualitative studies which investigated this relationship. Studies were critically appraised, and data were analysed using thematic analysis. Themes identified in the data were used to develop a model to build on the understanding of this issue. FINDINGS: The findings of this research highlighted two main themes, one related to perceptions of gender (intrinsic or extrinsic), the way it impacts on work-family conflict and its relationship to women's career progression. The second theme relates to structures which hinder or support women's ability to have work-life balance. A model was developed that represents the inter-relationship between these factors. INTERPRETATION: Changes in both organisational culture and individuals' perception in regard to gender roles, especially of those in leadership, are necessary to create an environment where the best talent in academic medicine is selected regardless of gender.

Mindfulness as taught in Dialectical Behaviour Therapy: A scoping review.

This scoping review considers 11 studies that have focussed on the effect of teaching the mindfulness element of Dialectical Behaviour Therapy (DBT) on clinical outcomes. These articles utilized either mindfulness skills as embedded into the full DBT-Skills programme or a stand-alone mindfulness skills module (DBT-M), as treatment for clinical populations. The review of the research found that clinical application of mindfulness as taught in DBT leads to increases in self-reported mindfulness-especially non-judgemental awareness along with psychological measures that suggests an increase in mindfulness, for example, improved attention. The studies demonstrated that an increase in mindfulness had a positive effect on some clinical symptoms such as symptoms of Borderline Personality Disorder. Not all of the studies controlled for the effect of group, amount of practice or other elements of DBT therapy. The findings suggest that more needs to be done to establish the underlying mechanisms of change when being taught mindfulness in DBT.

Telemedicine for Adults With Cochlear Implants in the United Kingdom (CHOICE): Protocol for a Prospective Interventional Multisite Study.

BACKGROUND: Cochlear implants provide hearing to approximately 750,000 people with deafness worldwide; these patients require lifelong follow-up. Care for adults with implants in the United Kingdom occurs at one of 19 centers, which may be far from the patients' homes. In a previous randomized controlled trial, we successfully introduced person-centered care. We designed, implemented, and evaluated the following remote care pathway: a personalized web-based support tool, home hearing check, self-device adjustment, and upgrading of sound processors at home rather than in the clinic. The remote care group had a significant increase in empowerment after using the tools, and the patients and clinicians were keen to continue. We would now like to scale up these improvements as an option for >12,000 UK adults using implants; we are commissioning an independent evaluation of this intervention and rollout to establish if it achieves its aims of more empowered and confident patients; more accessible and equitable care; stable hearing; more efficient, person-centered, and scalable service; and more satisfied and engaged patients and clinicians. OBJECTIVE: This study aims to evaluate the impact and rollout of a person-centered clinical care pathway via telemedicine for adults with cochlear implants in the United Kingdom, using both outcomes and process evaluation. METHODS: This project will scale up and evaluate a person-centered long-term follow-up pathway for adults using cochlear implants through a personalized website, including a home hearing check, uploading photos of cochlear implant site, listening in noise and music practice, ordering of spares, questionnaires, and other resources. Both quantitative and qualitative analyses will be conducted, and they will be both an outcome and process evaluation. RESULTS: As of July 2021, the trial is closed, and all data collection is complete. The evaluation report is expected to be published in December 2021, and the research data have not yet been analyzed. CONCLUSIONS: This project will present the results of the first scaling up of a remote care pathway for adults with cochlear implants in the United Kingdom. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number ISRCTN51668922; https://www.isrctn.com/ISRCTN51668922. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27207.

Potential factors that influence usage of complementary and alternative medicine worldwide: a systematic review.

OBJECTIVES: To determine similarities and differences in the reasons for using or not using complementary and alternative medicine (CAM) amongst general and condition-specific populations, and amongst populations in each region of the globe. METHODS: A literature search was performed on Pubmed, ScienceDirect and EMBASE. KEYWORDS: 'herbal medicine' OR 'herbal and dietary supplement' OR 'complementary and alternative medicine' AND 'reason' OR 'attitude'. Quantitative or qualitative original articles in English, published between 2003 and 2018 were reviewed. Conference proceedings, pilot studies, protocols, letters, and reviews were excluded. Papers were appraised using valid tools and a 'risk of bias' assessment was also performed. Thematic analysis was conducted. Reasons were coded in each paper, then codes were grouped into categories. If several categories reported similar reasons, these were combined into a theme. Themes were then analysed using χ2 tests to identify the main factors related to reasons for CAM usage. RESULTS: 231 publications were included. Reasons for CAM use amongst general and condition-specific populations were similar. The top three reasons for CAM use were: (1) having an expectation of benefits of CAM (84% of publications), (2) dissatisfaction with conventional medicine (37%) and (3) the perceived safety of CAM (37%). Internal health locus of control as an influencing factor was more likely to be reported in Western populations, whereas the social networks was a common factor amongst Asian populations (p < 0.05). Affordability, easy access to CAM and tradition were significant factors amongst African populations (p < 0.05). Negative attitudes towards CAM and satisfaction with conventional medicine (CM) were the main reasons for non-use (p < 0.05). CONCLUSIONS: Dissatisfaction with CM and positive attitudes toward CAM, motivate people to use CAM. In contrast, satisfaction with CM and negative attitudes towards CAM are the main reasons for non-use.

The TinMan study: feasibility trial of a psychologically informed, audiologist-delivered, manualised intervention for tinnitus.

OBJECTIVE: To develop a manualised psychological treatment for tinnitus that could enhance audiologist usual care, and to test feasibility of evaluating it in a randomised controlled trial. DESIGN: Feasibility trial, random allocation of patients to manualised treatment or treatment as usual, and mixed-methods evaluation. Study sample: Senior audiologists, and adults with chronic tinnitus. RESULTS: Recruitment reached 63% after 6 months (feasibility pre-defined as 65%). Only nine patients (47%) were retained for the duration of the trial. Patients reported that the treatment was acceptable and helped reassure them about their tinnitus. Audiologists reported mixed feelings about the kinds of techniques that are presented to them as 'psychologically informed'. Audiologists also reported lacking confidence because the training they had was brief, and stated that more formal supervision would have been helpful to check adherence to the treatment manual. CONCLUSIONS: The study indicate potential barriers to audiologist use of the manual, and that a clinical trial of the intervention is not yet feasible. However, positive indications from outcome measures suggest that further development work would be worthwhile. Refinements to the manual are indicated, and training and supervision arrangements to better support audiologists to use the intervention in the clinic are required. Trial Registration: ISRCTN13059163.

Children and young people with inflammatory bowel disease attend less school than their healthy peers.

OBJECTIVE: Chronic diseases, such as inflammatory bowel disease (IBD), can impact negatively on education and social development. Examining the impact of IBD on school/college attendance for children and young people (CYP) is vital to provide targeted support to patients, families and schools. METHODS: We performed a cross-sectional survey to determine the school/college attendance rates, the reasons for absence related to IBD and facilitators or barriers to school/college attendance. In a subset of patients followed up locally, we performed a detailed review of hospital attendance data to assess healthcare burden. RESULTS: Two hundred and thirty-one questionnaires were given to CYP with IBD aged 5-17 years. Response rate was 74% (final sample 169). The median school/college attendance rate was 92.5%, significantly lower than all children in England (95.2%). 39.6% of children with IBD were persistently absent, defined nationally as missing 10% or more of school. Only five children (3%) had a 100% attendance record. Increasing age and use of monoclonal therapy were predictors of poor school attendance. Concerns about feeling unwell at school/college, access to toilets, keeping up with work and teachers' understanding of IBD are the main issues for CYP with IBD. There was a significant negative correlation between number of days in hospital and school attendance. CONCLUSION: IBD has a significant impact on school/college attendance, with hospital attendance, disease burden and school difficulties being major factors. Employing strategies to minimise healthcare burden and developing a partnership between health and education to support children with IBD will serve to facilitate school/college attendance.

The ESCAPS study: a feasibility randomized controlled trial of early electrical stimulation to the wrist extensors and flexors to prevent post-stroke complications of pain and contractures in the paretic arm.

OBJECTIVE: To establish feasibility of initiating electrical stimulation treatment of wrist extensors and flexors in patients early after stroke to prevent muscle contractures and pain. DESIGN: Feasibility randomized controlled trial with economic evaluation. SETTING: A specialist stroke unit in Nottinghamshire. SUBJECTS: A total of 40 patients recruited within 72 hours post-stroke with arm hemiparesis. INTERVENTIONS: Participants were randomized to receive usual care or usual care and electrical stimulation to wrist flexors and extensors for 30 minutes, twice a day, five days a week for three months. Initial treatment was delivered by an occupational therapist or physiotherapist who trained participants to self-manage subsequent treatments. MEASURES: Measures of feasibility included recruitment and attrition rates, completion of treatment, and successful data collection. Outcome data on wrist range of motion, pain, arm function, independence, quality of life, and resource use were measured at 3-, 6-, and 12-months post-randomization. RESULTS: A total of 40 participants (of 215 potentially eligible) were recruited in 15 months (20 men; mean age: 72 (SD: 13.0)). Half the participants lacked mental capacity and were recruited by consultee consent. Attrition at three-month follow-up was 12.5% (death (n = 2), end-of-life care (n = 2), and unable to contact (n = 1)). Compliance varied (mean: 65 (SD: 53)) and ranged from 10 to 166 treatments per patient (target dosage was 120). Data for a valid economic analysis can be adequately collected. CONCLUSION: Early initiation of electrical stimulation was acceptable and feasible. Data collection methods used were feasible and acceptable to participants. A large definitive study is needed to determine if electrical stimulation is efficacious and cost effective.

Giving permission to care for people with dementia in residential homes: learning from a realist synthesis of hearing-related communication.

BACKGROUND: Managing hearing communication for residents living with hearing loss and dementia in long-term care settings is challenging. This paper explores how care can be effective in optimising hearing communication for residents living with dementia. We argue that the underlying notion of permission or authorisation allows care staff to do what they know will be effective in providing person-centred care that enhances hearing communication. The paper also indicates that this notion of permission can usefully be applied to other areas of care home practice. METHODS: To address hearing-related communication in care homes, we conducted a realist synthesis (RS). As a theory-driven approach to reviewing literature, it also uses expert opinion to understand complex health situations. Using RS, we developed a theory surrounding the management of hearing-related communication in care homes. Applying formal processes to the literature search and data extraction, the analysis uncovered relevant mechanisms and contexts to help confirm, refute or refine our understanding of how hearing communication could be improved. RESULTS: Forty-three papers were selected for the realist synthesis. The documents were analysed to construct five context-mechanism-outcome configurations (CMOCs). The CMOCs represent possible care interventions to optimise hearing-related communication in care homes for person living with dementia and hearing loss (PLWDHL). They include leadership promoting positive regard and empathy through person-centred care, communication training for staff, 'knowing the person' and relationship building for responsive awareness of residents' hearing needs, maintaining and monitoring hearing communication through care planning, and managing noise in the care home environment. CONCLUSIONS: Leadership that provides appropriate training and resources is likely to enhance knowledge and skills, leading to staff feeling able and equipped to respond to the hearing-related communication needs of PLWDHL. Collaboration with local hearing services is likely to raise awareness of hearing loss among care home staff. Importantly, care staff require a sense of permission from leadership, to work with knowledge and autonomy in the interest of residents living with dementia and hearing loss.

A Feasibility Cluster Randomized Controlled Trial of Individual Placement and Support (IPS) for Patients With Offending Histories.

Objective: To examine the feasibility of conducting a fully powered randomized controlled trial (RCT) of Individual Placement and Support (IPS). IPS is a form of supported employment which aims to put people into open employment quickly and in accordance with their preferences. It is delivered by employment specialists collocated within clinical teams, and provides time unlimited support for the individual and their employer, along with welfare benefits counselling. Method: A feasibility cluster RCT of treatment as usual (TAU) plus IPS versus TAU alone was conducted over 12 months among patients with offending histories in a community forensic setting in the UK. The feasibility criteria were to achieve 50% recruitment rate; 50% completion rate for IPS; 50% completion rate of all outcome measures; and 80% acceptability rating for IPS. The primary efficacy outcome was the proportion of people in open employment at 12 months. The secondary outcomes were other vocational and educational activities; Brief Psychiatric Rating Scale; Rosenberg's Self-esteem Scale; Client Service Receipt Inventory; quality of life using the SF12-v2 and EQ5-D3; Social Functioning Questionnaire; Work Limitation Questionnaire; and reoffending. Results: Participants' mean age was 39.2 years. The majority were male (88.9), White British (72.2), and single (72.2%). Over 72% had no higher qualification beyond secondary education; mean years in education was 10.4. Over one third had schizophrenia, one fifth had depression, and the rest had personality disorder as their primary diagnosis. Participants had a lifetime average of 7.5 convictions for 15.5 offences. The recruitment rate of all referrals was 38.3% (IPS n = 11; TAU n = 7). Completion rate for IPS was 54.5, with 45.5% acceptability rating. Completion rates for outcome measures for the groups at baseline and 12 months ranged from 22.2 to 100%. The proportion of people in open employment at 12 months were 9.1 and 0% for IPS and TAU respectively. Conclusion: It is not feasible to conduct a full RCT of IPS in community forensic settings in the UK owing to recruitment and retention difficulties. Conducting a trial of this kind requires a large pool of patients from multiple sites and longer IPS implementation and recruitment periods than those of this study. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02442193.

Patients' and Clinicians' Views of the Psychological Components of Tinnitus Treatment That Could Inform Audiologists' Usual Care: A Delphi Survey.

OBJECTIVES: The aim of this study was to determine which components of psychological therapies are most important and appropriate to inform audiologists' usual care for people with tinnitus. DESIGN: A 39-member panel of patients, audiologists, hearing therapists, and psychologists completed a three-round Delphi survey to reach consensus on essential components of audiologist-delivered psychologically informed care for tinnitus. RESULTS: Consensus (≥80% agreement) was reached on including 76 of 160 components. No components reached consensus for exclusion. The components reaching consensus were predominantly common therapeutic skills such as Socratic questioning and active listening, rather than specific techniques, for example, graded exposure therapy or cognitive restructuring. Consensus on educational components to include largely concerned psychological models of tinnitus rather than neurophysiological information. CONCLUSIONS: The results of this Delphi survey provide a tool to develop audiologists' usual tinnitus care using components that both patients and clinicians agree are important and appropriate to be delivered by an audiologist for adults with tinnitus-related distress. Research is now necessary to test the added effects of these components when delivered by audiologists.

Evaluating the safety and efficacy of regional citrate compared to systemic heparin as anticoagulation for continuous renal replacement therapy in critically ill patients: A service evaluation following a change in practice.

Following the implementation of citrate anticoagulation for continuous renal replacement therapy, we evaluate its first year of use and compare it to the previously used heparin, to assess whether our patients benefit from the recently reported advantages of citrate. We retrospectively analysed 2 years of data to compare the safety and efficacy of citrate versus heparin. The results have shown that 43 patients received continuous renal replacement therapy with heparin, 37 patients with citrate. We found no significant difference in metabolic control of pH, urea and creatinine after 72 h. Filters anticoagulated with citrate had significantly longer median lifespan (33 h vs 17 h; p = 0.001), shorter downtime (0 h vs 5 h; p = 0.015) and less filter sets per patient day (0.37 vs 0.67; p = 0.002). Filters anticoagulated with heparin were commonly interrupted due to clotting (50% vs 16.4%), whereas filters anticoagulated with citrate were often stopped electively (53.4% vs 24.6%). Patients on heparin filters had significantly higher APPTs, some at potentially dangerous levels (>180 s), whilst patients on citrate filters had significantly higher levels of bicarbonate. Therefore, we conclude that citrate is superior in terms of safety and efficacy, with longer filter lifespan. It has become our first line anticoagulant for continuous renal replacement therapy.

Co-producing public involvement training with members of the public and research organisations in the East Midlands: creating, delivering and evaluating the lay assessor training programme.

PLAIN ENGLISH SUMMARY: Members of the public share their views with researchers to improve health and social care research. Lay assessing is one way of doing this. This is where people, drawing upon personal and general life experience, comment on material, such as grant applications and patient information, to highlight strengths and weaknesses and to suggest improvements. This paper reports on setting up a training programme for lay assessors. Meetings were held between interested public and staff from research organisations. People discussed what lay assessing is, why they want to do it, skills and support needed and if training was wanted. They were invited to form a group to develop the training together. Training was delivered in the East Midlands. People who attended gave their thoughts about it by completing questionnaires and joining a feedback event. The group developed the structure of the training programme together and it oversaw the development of the training content by individual members. People who attended training reported feeling more confident about lay assessing. This was particularly so for those who had not done lay assessing before. They indicated how valuable it was to talk with others at the training. Our findings support the National Institute for Health Research recommendations for improving learning and development for public involvement in research. This project has created a solid base for local research organisations to work together in public involvement training. Lay assessor training is now part of a wider programme of shared resources called the Sharebank. ABSTRACT: Background Involving members of the public in research can improve its quality and incorporate the needs and views of patients. One method for doing this is lay assessing, where members of the public are consulted to improve research materials. This paper documents the establishment of a pilot training programme for lay assessors. It describes a way of working that embodies a regional, cross-organisational approach to co-producing training with members of the public. Methods Open meetings, led by AH, were held for existing and aspiring lay assessors to define lay assessing, motivations for doing it, skills required, associated learning and development needs, and to gauge interest for training. Those who attended meetings, including members of the public and staff, were invited to form a working group to co-produce the training programme. Training was delivered in modules at two centres in the East Midlands and evaluated through participant feedback at the end of each module and at an evaluation event. Feedback was through a mix of Likert scale scoring, open text and verbal responses. Results Discussions from the open meetings informed the development of the training by the working group. Led by AH, the working group, as a whole, co-produced the structure and format of the training and oversaw training content development by individuals within the group. Training was well-received by participants. Feedback through Likert scoring (n = 14) indicated higher feelings of confidence in knowledge of relevant subject matter and in fulfilling the lay assessor role, particularly amongst those who had not done lay assessing before. Opportunities that the training afforded for interaction between participants - sharing of varied experiences and knowledge - and a 'learn by doing' approach was of particular value, as indicated by 10 responses to open-ended questions. Conclusions This project has created a solid foundation for collaboration between research organisations in the East Midlands in devising and delivering training in public involvement together. Our evaluation provides evidence in support of National Institute for Health Research (NIHR) recommendations on principles for learning and development for public involvement in research.

Systematic review of interventions for treating or preventing antipsychotic-induced tardive dyskinesia.

BACKGROUND: Antipsychotic medication can cause tardive dyskinesia (TD) - late-onset, involuntary, repetitive movements, often involving the face and tongue. TD occurs in > 20% of adults taking antipsychotic medication (first-generation antipsychotics for > 3 months), with this proportion increasing by 5% per year among those who continue to use these drugs. The incidence of TD among those taking newer antipsychotics is not different from the rate in people who have used older-generation drugs in moderate doses. Studies of TD have previously been found to be limited, with no treatment approach shown to be effective. OBJECTIVES: To summarise the clinical effectiveness and safety of treatments for TD by updating past Cochrane reviews with new evidence and improved methods; to undertake public consultation to gauge the importance of the topic for people living with TD/the risk of TD; and to make available all data from relevant trials. DATA SOURCES: All relevant randomised controlled trials (RCTs) and observational studies. REVIEW METHODS: Cochrane review methods, network meta-analysis (NMA). DESIGN: Systematic reviews, patient and public involvement consultation and NMA. SETTING: Any setting, inpatient or outpatient. PARTICIPANTS: For systematic reviews, adults with TD who have been taking a stable antipsychotic drug dose for > 3 months. INTERVENTIONS: Any, with emphasis on those relevant to UK NHS practice. MAIN OUTCOME MEASURES: Any measure of TD, global assessments and adverse effects/events. RESULTS: We included 112 studies (nine Cochrane reviews). Overall, risk of bias showed little sign of improvement over two decades. Taking the outcome of 'TD symptoms improved to a clinically important extent', we identified two trials investigating reduction of antipsychotic dose [n = 17, risk ratio (RR) 0.42, 95% confidence interval (CI) 0.17 to 1.04; very low quality]. Switching was investigated twice in trials that could not be combined (switching to risperidone vs. antipsychotic withdrawal: one RCT, n = 42, RR 0.45, 95% CI 0.23 to 0.89; low quality; switching to quetiapine vs. haloperidol: one RCT, n = 45, RR 0.80, 95% CI 0.52 to 1.22; low quality). In addition to RCTs, six observational studies compared antipsychotic discontinuation with decreased or increased dosage, and there was no clear evidence that any of these strategies had a beneficial effect on TD symptoms (very low-quality evidence). We evaluated the addition to standard antipsychotic care of several treatments, but not anticholinergic treatments, for which we identified no trials. We found no clear effect of the addition of either benzodiazepines (two RCTs, n = 32, RR 1.12, 95% CI 0.6 to 2.09; very low quality) or vitamin E (six RCTs, n = 264, RR 0.95, 95% CI 0.89 to 1.01; low quality). Buspirone as an adjunctive treatment did have some effect in one small study (n = 42, RR 0.53, 95% CI 0.33 to 0.84; low quality), as did hypnosis and relaxation (one RCT, n = 15, RR 0.45, 95% CI 0.21 to 0.94; very low quality). We identified no studies focusing on TD in people with dementia. The NMA model found indirect estimates to be imprecise and failed to produce useful summaries on relative effects of interventions or interpretable results for decision-making. Consultation with people with/at risk of TD highlighted that management of TD remains a concern, and found that people are deeply disappointed at the length of time it has taken researchers to address the issue. LIMITATIONS: Most studies remain small and poorly reported. CONCLUSIONS: Clinicians, policy-makers and people with/at risk of TD are little better informed than they were decades ago. Underpowered trials of limited quality repeatedly fail to provide answers. FUTURE WORK: TD reviews have data from current trials extracted, tabulated and traceable to source. The NMA highlights one context in which support for this technique is ill advised. All relevant trials, even if not primarily addressing the issue of TD, should report appropriate binary outcomes on groups of people with this problem. Randomised trials of treatments for people with established TD are indicated. These should be large (> 800 participants), necessitating accrual through accurate local/national registers, including an intervention with acceptable treatments and recording outcomes used in clinical practice. STUDY REGISTRATION: This study is registered as PROSPERO CRD4201502045. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Crowdfunding: an innovative way to fund your project.

Background Getting research funded is extremely difficult, with research councils rejecting more than 70% of grant applications ( Else 2014 ). It is even more difficult if you are a junior researcher who doesn't have a track record of being awarded grant money or leading a research project. Crowdfunding may offer a solution. It is a method of raising funds from members of the public online and can offer an alternative to the more formal methods of research funding. Aim To outline how this model works and provide tips on designing a campaign. Discussion The authors provide an overview of the literature regarding this model, as well as a set of resources for future reference when designing a campaign. Conclusion Crowdfunding can provide small amounts of money for your first project. Implications for practice It is expected that clinicians practice evidence based medicine, and research in health environments is commonplace. Crowdfunding can offer you support in becoming more engaged in research.

A psychologically informed, audiologist-delivered, manualised intervention for tinnitus: protocol for a randomised controlled feasibility trial (Tin Man study).

BACKGROUND: Chronic tinnitus is a common incurable condition often associated with depression, anxiety, insomnia and reduced quality of life. Within National Health Service (NHS) audiology in the United Kingdom (UK), no standard protocol currently exists for the treatment of tinnitus. Counselling is only available in less than half of audiology departments, and there is no agreed standard for what constitutes tinnitus counselling. There is substantial evidence from systematic reviews for the clinical benefit of cognitive behaviour therapy (CBT) for tinnitus delivered by clinical psychologists or psychiatrists, but no studies have sufficiently evidenced the NHS model of tinnitus care where management is increasingly being delivered by audiology professionals. In a pilot randomised controlled trial (RCT), this study aims to evaluate the feasibility of comparing a psychologically informed guidance manual developed to support audiologist management of tinnitus with usual treatment. METHODS/DESIGN: Phase 1 consisted of three development stages: (1) a scoping review to generate a comprehensive set of tinnitus counselling components, (2) a Delphi survey involving expert patients (n = 18) and clinicians (n = 21) to establish consensus on the essential core attributes of tinnitus counselling, and (3) incorporation of these elements into a manualised care protocol. In phase 2, following training in a dedicated workshop, the manualised intervention will be delivered by three experienced audiologists across three different sites. Patients (n = 30) will be randomly allocated to receive either (1) psychologically informed management from an audiologist trained to deliver the manualised intervention or (2) treatment as usual (TAU) from an audiologist who has not received this training. Quantitative outcome measures will be administered at baseline, discharge and 6-month follow-up. Qualitative interviews with participating patients and clinicians will be conducted to gather perspectives on the feasibility and acceptability of the manualised intervention. DISCUSSION: The feasibility of proceeding to a definitive RCT will be assessed via compliance with the manual, willingness to be randomised, number of eligible participants, rate of recruitment, retention and collection of quantitative outcome measures. This research offers an important first step to an evidence-based, standardised and accessible approach to tinnitus care. TRIAL REGISTRATION: ISRCTN13059163. Date of registration: 6 May 2016.

A systematic review and synthesis of outcome domains for use within forensic services for people with intellectual disabilities.

BACKGROUND: There is limited empirical information on service-level outcome domains and indicators for the large number of people with intellectual disabilities being treated in forensic psychiatric hospitals. AIMS: This study identified and developed the domains that should be used to measure treatment outcomes for this population. METHOD: A systematic review of the literature highlighted 60 studies which met eligibility criteria; they were synthesised using content analysis. The findings were refined within a consultation and consensus exercises with carers, patients and experts. RESULTS: The final framework encompassed three a priori superordinate domains: (a) effectiveness, (b) patient safety and (c) patient and carer experience. Within each of these, further sub-domains emerged from our systematic review and consultation exercises. These included severity of clinical symptoms, offending behaviours, reactive and restrictive interventions, quality of life and patient satisfaction. CONCLUSIONS: To index recovery, services need to measure treatment outcomes using this framework. DECLARATION OF INTEREST: None. COPYRIGHT AND USAGE: © The Royal College of Psychiatrists 2017. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) licence.

Psychological Therapy for People with Tinnitus: A Scoping Review of Treatment Components.

BACKGROUND: Tinnitus is associated with depression and anxiety disorders, severely and adversely affecting the quality of life and functional health status for some people. With the dearth of clinical psychologists embedded in audiology services and the cessation of training for hearing therapists in the UK, it is left to audiologists to meet the psychological needs of many patients with tinnitus. However, there is no universally standardized training or manualized intervention specifically for audiologists across the whole UK public healthcare system and similar systems elsewhere across the world. OBJECTIVES: The primary aim of this scoping review was to catalog the components of psychological therapies for people with tinnitus, which have been used or tested by psychologists, so that they might inform the development of a standardized audiologist-delivered psychological intervention. Secondary aims of this article were to identify the types of psychological therapy for people with tinnitus, who were reported but not tested in any clinical trial, as well as the job roles of clinicians who delivered psychological therapy for people with tinnitus in the literature. DESIGN: The authors searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; Cochrane Central Register of Controlled Trials; PubMed; EMBASE; CINAHL; LILACS; KoreaMed; IndMed; PakMediNet; CAB Abstracts; Web of Science; BIOSIS Previews; ISRCTN; ClinicalTrials.gov; IC-TRP; and Google Scholar. In addition, the authors searched the gray literature including conference abstracts, dissertations, and editorials. No records were excluded on the basis of controls used, outcomes reached, timing, setting, or study design (except for reviews-of the search results. Records were included in which a psychological therapy intervention was reported to address adults (≤18 years) tinnitus-related distress. No restrictive criteria were placed upon the term tinnitus. Records were excluded in which the intervention included biofeedback, habituation, hypnosis, or relaxation as necessary parts of the treatment. RESULTS: A total of 5043 records were retrieved of which 64 were retained. Twenty-five themes of components that have been included within a psychological therapy were identified, including tinnitus education, psychoeducation, evaluation treatment rationale, treatment planning, problem-solving behavioral intervention, thought identification, thought challenging, worry time, emotions, social comparison, interpersonal skills, self-concept, lifestyle advice, acceptance and defusion, mindfulness, attention, relaxation, sleep, sound enrichment, comorbidity, treatment reflection, relapse prevention, and common therapeutic skills. The most frequently reported psychological therapies were cognitive behavioral therapy, tinnitus education, and internet-delivered cognitive behavioral therapy. No records reported that an audiologist delivered any of these psychological therapies in the context of an empirical trial in which their role was clearly delineated from that of other clinicians. CONCLUSIONS: Scoping review methodology does not attempt to appraise the quality of evidence or synthesize the included records. Further research should therefore determine the relative importance of these different components of psychological therapies from the perspective of the patient and the clinician.