Partnerships between deaf people and hearing dogs (PEDRO) : Effectiveness and Cost-Effectiveness of Receiving a Hearing Dog on Mental Well-Being and Health in People With Hearing Loss: Protocol for a Randomized Controlled Trial

Background People with hearing loss, particularly those who lose their hearing in adulthood, are at increased risk of social isolation, mental health difficulties, unemployment, loss of independence, risk of accidents, and impaired quality of life. In the United Kingdom (UK), a single third sector organisation provides hearing dogs, a specific type of assistance dog trained to provide sound support to people with hearing loss. These dogs may also deliver numerous psychosocial benefits to recipients. This has not previously been fully investigated. Objective To evaluate the impact of a hearing dog partnership on the lives of individuals with severe or profound hearing loss. Methods and Analysis A two-arm, randomised controlled trial conducted within the UK, with 162 hearing dog applicants, aged 18 years and over. Participants will be randomised 1:1 using a matched-pairs design to receive a hearing dog sooner than usual (intervention arm – Arm B) or to receive a hearing dog within the usual timeframe (comparator arm – Arm A). In the effectiveness analysis, the primary outcome is a comparison of mental wellbeing six-months after Arm B have received a hearing dog (Arm A: not yet received hearing dog), measured using the Short Warwick Edinburgh Mental Wellbeing Scale. Secondary outcome measures include the PHQ-9, GAD-7 and WSAS. An economic evaluation will assess cost-effectiveness including health-related quality-adjusted life years using the EQ-5D-5L and social-care-related-quality-adjusted life-years. Participants will be followed up for up to two years. A nested qualitative study will investigate the impacts of having a hearing dog and how these impacts come about. Results The study was funded by the National Institute for Health Research’s School for Social Care Research. Recruitment commenced in March 2017 and is now complete. 165 participants were randomised. Data collection will continue until January 2020. Results will be published in peer-reviewed journals and at conferences. A summary of the findings will be made available to participants. Ethical approval was received from the University of York’s Department of Social Policy and Social Work Research Ethics Committee (reference SPSW/S/17/1). Conclusions The findings from this study will provide, for the first time, strong and reliable evidence on the impact of having a hearing dog on people’s lives in terms of their quality of life, well-being and mental health. Trial registration The trial has been retrospectively registered International Standard Randomised Controlled Trial Number (ISRCTN) 36452009; https://doi.org/10.1186/ISRCTN36452009. Trial status: Ongoing

Hearing dogs for people with severe and profound hearing loss: a wait-list design randomised controlled trial investigating their effectiveness and cost-effectiveness

Abstract Background Hearing loss increases the risk of poor outcomes across a range of life domains. Where hearing loss is severe or profound, audiological interventions and rehabilitation have limited impact. Hearing dogs offer an alternative, or additional, intervention. They live permanently with recipients, providing sound support and companionship. Methods A single-centre, randomised controlled trial (RCT) evaluated the impacts of a hearing dog on mental well-being, anxiety, depression, problems associated with hearing loss (responding to sounds, fearfulness/social isolation), and perceived dependency on others. Participants were applicants to the UK charity ‘Hearing Dogs for Deaf People’. Eligibility criteria were as follows: first-time applicant; applying for a hearing dog (as opposed to other support provided by the charity). Participants were randomised 1:1 to the following: receive a hearing dog sooner than usual [HD], or within the usual application timeframe (wait-list [WL] comparator). The primary outcome was mental well-being (Short Warwick-Edinburgh Mental Well-Being Scale) 6 months (T1) after HD received a hearing dog. The cost-effectiveness analysis took a health and social care perspective. Results In total, 165 participants were randomised (HD n = 83, WL n = 82). A total of 112 (67.9%) were included in the primary analysis (HD n = 55, WL n = 57). At T1, mental well-being was significantly higher in the HD arm (adjusted mean difference 2.53, 95% CI 1.27 to 3.79, p < 0.001). Significant improvements in anxiety, depression, functioning, fearfulness/social isolation, and perceived dependency, favouring the HD arm, were also observed. On average, HD participants had used fewer statutory health and social care resources. In a scenario whereby costs of provision were borne by the public sector, hearing dogs do not appear to be value for money. If the public sector made a partial contribution, it is possible that hearing dogs would be cost-effective from a public sector perspective. Conclusions Hearing dogs appear to benefit recipients across a number of life domains, at least in the short term. Within the current funding model (costs entirely borne by the charity), hearing dogs are cost-effective from the public sector perspective. Whilst it would not be cost-effective to fully fund the provision of hearing dogs by the public sector, a partial contribution could be explored. Trial registration The trial was retrospectively registered with the International Standard Randomised Controlled Trial Number (ISRCTN) registry on 28.1.2019: ISRCTN36452009

Outcome domains and outcome measures used in studies assessing the effectiveness of interventions to manage non-respiratory sleep disturbances in children with neurodisabilities: a systematic review

Objectives: To assess whether a core outcome set is required for studies evaluating the effectiveness of interventions for non-respiratory sleep disturbances in children with neurodisabilities. Design: Survey of outcome measures used in primary studies identified by a systematic review. Data sources: ASSIA; CENTRAL; Cochrane Database of Systematic Reviews; Conference Proceedings Citation Index; CINAHL; DARE; Embase; HMIC; MEDLINE; MEDLINE In-Process; PsycINFO; Science Citation Index; Social Care Online; Social Policy & Practice; ClinicalTrials.gov; WHO International Clinical Trials Registry Platform (ICTRP); and the UK Clinical Trials Gateway were searched up to February 2017. Eligibility criteria: Studies evaluating pharmacological or non-pharmacological interventions for children (≤ 18 years old) with a neurodisability and experiencing non-respiratory sleep disturbance. Data extraction and synthesis: Outcomes related to child and parent sleep-related outcomes; measures of perceived parenting confidence, efficacy or understanding of sleep management; child-related quality of life, daytime behaviour and cognition; parent/carer outcomes; and adverse events were listed from each study and categorised into domains. Results: Thirty-nine studies (13 melatonin and 26 non-pharmacological) assessed five core outcome areas: child sleep, other child outcomes, parent outcomes, adverse events and process measures. There were 54 different measures of child related sleep across five domains: global measures; sleep initiation; maintenance; scheduling; and other outcomes. The most commonly reported measure in melatonin studies was total sleep time (n=12; 92%); and for non-pharmacological studies was the parent-reported Child Sleep Habits Questionnaire (CSHQ; 58%), both classified as global measures. Fifteen non-pharmacological (58%) and four pharmacological studies (31%) reported child outcomes other than sleep. The domains assessed (using 29 different measures) were child behaviour, quality of life, ADHD symptoms, cognition, school-related, and other. One pharmacological and 14 non-pharmacological (54%) studies reported parent outcomes (17 different measures). Eleven melatonin studies (85%) recorded adverse events, with variation in how data were collected and reported. One non-pharmacological study reported an explicit method of collecting on adverse events. Several process measures were reported, related to adherence, feasibility of delivery, acceptability and experiences of receiving the intervention. Conclusions: There is a lack of consistency between studies in the outcome measures used to assess the effectiveness of interventions for non-respiratory sleep disturbances in children with neurodisabilities. A minimum core outcome set, with international consensus, should be developed in consultation with parents, children and young people, and those involved in supporting families. Registration number systematic review PROSPERO (CRD42016034067

Oral Melatonin for Non-Respiratory Sleep Disturbance in Children with Neurodisabilities: Systematic Review and Meta-Analyses

Aim: To evaluate the effectiveness of pharmacological interventions for managing non-respiratory sleep disturbances in children with neurodisabilities. Method: We performed a systematic review and meta-analyses of randomized controlled trials (RCTs). We searched 16 databases, grey literature, and reference lists of included papers up to February 2017. Data were extracted and assessed for quality by two researchers (B.B., C.M., G.S., A.S., A.P.). Results: Thirteen trials were included, all evaluating oral melatonin. All except one were at high or unclear risk of bias. There was a statistically significant increase in diary-reported total sleep time for melatonin compared with placebo (pooled mean difference 29.6min, 95% confidence interval [CI] 6.9–52.4, p=0.01). Statistical heterogeneity was high (97%). For the single RCT with low risk of bias, the unadjusted mean difference in total sleep time was 13.2 minutes (95% CI −13.3 to 39.7) favouring melatonin, while the mean difference adjusted for baseline total sleep time was statistically significant (22.4min, 95% CI 0.5–44.3, p=0.04). Adverse event profile suggested that melatonin was well-tolerated. Interpretation: There is a paucity of evidence on managing sleep disturbances in children with neurodisabilities, and it is mostly of limited scope and poor quality. There is evidence of the benefit and safety of melatonin compared with placebo, although the extent of this benefit is unclear. What this paper adds: Melatonin for the management of non-respiratory sleep disturbances in children with neurodisabilities was well tolerated with minimal adverse effects. The extent of benefit and which children might benefit most from melatonin use is uncertain. Benefit may be greatest in those with autism spectrum disorder; however, this finding should be interpreted with caution

Can’t talk about it, won’t talk about it : how do alexithymia and experiential avoidance relate to men’s experience of psychological distress?

Alexithymia and experiential avoidance have both been shown to share substantial relationships with poor mental health outcomes. Both constructs may have heightened importance for men, as male gender is associated with higher rates of alexithymia as well as the increased use of harmful experientially-avoidant coping strategies. Recent research has turned its attention towards the hypothesis that the relationship between alexithymia and negative psychological wellbeing may be as a result of the inflexible application of broader belief systems endorsing the benefits of experientially avoidant coping. This may be particularly relevant for men, who are arguably socialised into suppressing emotional states viewed as unacceptable within dominant masculinity scripts. This thesis aimed to explore the impact of experiential avoidance on the relationship between alexithymia and psychological wellbeing. Specifically, Part One of this portfolio contains a systematic literature review exploring the current evidence base pertaining to the question: how are alexithymia and experiential avoidance related? The findings of the review suggest that studies consistently report positive, significant relationships between alexithymia and experiential avoidance. Additionally, although there have been some mixed findings from mediation analyses, the weight of evidence currently appears in support of experiential avoidance being a critical mediator in the relationship between alexithymia and poorer psychological wellbeing. Part Two presents an empirical paper that investigated the mediating role of experiential avoidance in the relationship between alexithymia and experiential avoidance in men. Findings supported experiential avoidance having a mediating role in this relationship, consistent across depression, anxiety and stress. Findings support the conceptualisation of alexithymia as a learned coping response, which develops alongside preferences for avoidant coping more generally i.e. psychological inflexibility. Parts Three and Four of this portfolio contain details of the clinical experience and academic assignments also completed as part of this clinical doctorate programme

Coping and adjustment in men with prostate cancer: a systematic review of qualitative studies

Purpose Prostate cancer (PCa) is one of the most common forms of cancer amongst males. Men’s coping responses are an important determinant of functioning and adjustment to this disease. Previous qualitative research exists in this area, but the current review sought to systematically review and summarise these studies. Methods A systematic review was conducted to identify studies concerned with men’s coping strategies in their attempts to live with PCa. A search of relevant electronic databases was conducted to identify studies that met inclusion criteria for this review. Methodological quality assessment was also undertaken for each included study. Results One hundred twenty-one publications were identified for initial screening, and 18 studies were included in the review. A total of five coping strategy categories or ‘meta-themes’ were identified across included studies. These categories were labelled ‘avoidance, minimisation, and withdrawal’, ‘directing cognition and attention’, ‘reframing masculinity and seeking support’, ‘retain pre-illness identity and lifestyle’, and ‘symptom/side-effect management’. Conclusions A range of coping strategies were reported by men with PCa. Some of these strategies appear to be partially influenced by gender roles and masculinities. Coping meta-themes reported in this review have also been found in other research on men’s coping. Strategies relating to flexible interpretation of gender roles/masculinities may be a particularly relevant category of coping responses due to the hypothesised beneficial impact of flexibility on psychological well-being.</p

Coping and adjustment in men with prostate cancer: a systematic review of qualitative studies

Purpose Prostate cancer (PCa) is one of the most common forms of cancer amongst males. Men’s coping responses are an important determinant of functioning and adjustment to this disease. Previous qualitative research exists in this area, but the current review sought to systematically review and summarise these studies. Methods A systematic review was conducted to identify studies concerned with men’s coping strategies in their attempts to live with PCa. A search of relevant electronic databases was conducted to identify studies that met inclusion criteria for this review. Methodological quality assessment was also undertaken for each included study. Results One hundred twenty-one publications were identified for initial screening, and 18 studies were included in the review. A total of five coping strategy categories or ‘meta-themes’ were identified across included studies. These categories were labelled ‘avoidance, minimisation, and withdrawal’, ‘directing cognition and attention’, ‘reframing masculinity and seeking support’, ‘retain pre-illness identity and lifestyle’, and ‘symptom/side-effect management’. Conclusions A range of coping strategies were reported by men with PCa. Some of these strategies appear to be partially influenced by gender roles and masculinities. Coping meta-themes reported in this review have also been found in other research on men’s coping. Strategies relating to flexible interpretation of gender roles/masculinities may be a particularly relevant category of coping responses due to the hypothesised beneficial impact of flexibility on psychological well-being.</p

Telehealth Autism Diagnostic Assessments with Children, Young People, and Adults:Qualitative Interview Study with England-Wide Multidisciplinary Health Professionals

BACKGROUND: Autism spectrum disorder (hereafter, autism) is a common neurodevelopmental condition. Core traits can range from subtle to severe and fluctuate depending on context. Individuals can present for diagnostic assessments during childhood or adulthood. However, waiting times for assessment are typically lengthy, and many individuals wait months or even years to be seen. Traditionally, there has been a lack of standardization between services regarding how many and which multidisciplinary health professionals are involved in the assessment and the methods (diagnostic tools) that are used. The COVID-19 pandemic has affected routine service provision because of stay-at-home mandates and social distancing guidelines. Autism diagnostic services have had to adapt, such as by switching from conducting assessments in person to doing these fully via telehealth (defined as the use of remote technologies for the provision of health care) or using blended in-person or telehealth methods. OBJECTIVE: This study explored health professionals’ experiences of and perspectives about conducting telehealth autism diagnostic assessments, including barriers and facilitators to this, during the COVID-19 pandemic; potential telehealth training and supervision needs of health professionals; how the quality and effectiveness of telehealth autism diagnostic services can be enhanced; and experiences of delivering postdiagnostic support remotely. METHODS: A total of 45 health professionals, working in varied settings across England, participated in one-off, in-depth semistructured qualitative interviews. These were conducted via videoconferencing or telephone. Altogether, participants represented 7 professional disciplines (psychiatry, medicine, psychology, speech and language therapy, occupational therapy, nursing, and social work). The data were then analyzed thematically. RESULTS: Thematic analysis indicated the following 7 themes: practicalities of telehealth, telehealth autism diagnostic assessments, diagnostic conclusions, clinical considerations, postdiagnostic support, future ways of working, and health professionals’ experiences and needs. Overall, telehealth autism diagnostic assessments were deemed by many participants to be convenient, flexible, and efficient for some patients, families, and health professionals. However, not all patients could be assessed in this way, for example, because of digital poverty, complex clinical presentation, or concerns about risk and safeguarding. Working remotely encouraged innovation, including the development of novel assessment measures. However, some participants expressed significant concerns about the validity and reliability of remotely assessing social communication conditions. CONCLUSIONS: A shift to telehealth meant that autism diagnostic services remained operational during the COVID-19 pandemic. However, this method of working has potentially affected the parity of service, with people presenting with clinical complexity having to potentially wait longer to be seen or given a diagnostic opinion. There is also a lack of standardization in the provision of services. Further research should identify evidence-based ways of enhancing the timeliness, accessibility, and robustness of the autism diagnostic pathway, as well as the validity and reliability of telehealth methods