Shared characteristics of intervention techniques for oral vocabulary and speech comprehensibility in preschool children with co-occurring features of developmental language disorder and speech sound disorder: a systematic review with narrative synthesis.

OBJECTIVES: To descriptively compare and contrast intervention techniques for preschool children with features of developmental language disorder (outcome: oral vocabulary) and speech sound disorder (outcome: speech comprehensibility) and analyse them in relation to effectiveness and theory. DESIGN: This is a systematic review with narrative synthesis. The process was supported by an expert steering group consisting of relevant professionals and people with lived experience. DATA SOURCES: Ovid Emcare, MEDLINE Complete, CINAHL, APA PsycINFO, ERIC, and Communication Source from January 2012 were searched. Relevant studies were obtained from an initial published review (up to January 2012). ELIGIBILITY CRITERIA: Interventions for preschool children (80% aged 2:0-5:11 years) with idiopathic speech or language needs; outcomes relating to either oral vocabulary or speech comprehensibility. DATA EXTRACTION AND SYNTHESIS: Searches were conducted on 27 January 2023. Two independent researchers screened at abstract and full-text levels. Data regarding intervention content (eg, techniques) and format/delivery (eg, dosage, location) were extracted. Data were synthesised narratively according to the methods of Campbell et al. RESULTS: 24 studies were included: 18 for oral vocabulary and 6 for speech comprehensibility. There were 11 randomised controlled trials, 2 cohort studies and 11 case series. Similarities included a focus on input-related techniques and similar therapy activities. Speech studies were more likely to be professional-led and clinic-led, rather than at home and through a parent. Analysis was restricted by heterogeneity in study design and terminology, as well as gaps within intervention reporting. Information deemed important to the expert steering group was missing. CONCLUSIONS: Similarities and differences between intervention techniques for oral vocabulary and speech comprehensibility have been identified and synthesised. However, analysis of effectiveness was limited due to issues with study design and heterogeneity within studies. This has implications for the progression of the evidence base within the field. PROSPERO REGISTRATION NUMBER: CRD42022373931.

Use of nominal group technique methods in the virtual setting: A reflective account and recommendations for practice.

Nominal group technique methods involve the use of structured activities within groups comprised of purposefully selected stakeholders (nominal groups), with the broad aim of achieving a level of consensus and prioritising information. In this paper, we will report how we facilitated nominal groups, using Microsoft Teams, to prioritise content for a theory-based behaviour change intervention to improve responses to clinically deteriorating patients. Our methods incorporated development and piloting of research materials, facilitation of online nominal groups with different stakeholders, and a structured approach to ranking behaviour change strategies. Practical suggestions are offered based on our experience of using this method in a virtual context.

Shared characteristics of intervention techniques for oral vocabulary and speech comprehensibility in preschool children with co-occurring features of developmental language disorder and a phonological speech sound disorder: protocol for a systematic review with narrative synthesis.

INTRODUCTION: Evidence suggests that over one-third of young children with developmental language disorder (DLD) or speech sound disorder (SSD) have co-occurring features of both. A co-occurring DLD and SSD profile is associated with negative long-term outcomes relating to communication, literacy and emotional well-being. However, the best treatment approach for young children with this profile is not understood. The aim of the proposed review is to identify intervention techniques for both DLD and SSD, along with their shared characteristics. The findings will then be analysed in the context of relevant theory. This will inform the content for a new or adapted intervention for these children. METHODS AND ANALYSIS: This search will build on a previous systematic review by Roulstone et al (2015) but with a specific focus on oral vocabulary (DLD outcome) and speech comprehensibility (SSD outcome). These outcomes were identified by parents and speech and language therapists within the prestudy stakeholder engagement work. The following databases will be searched for articles from January 2012 onwards: Ovid Emcare, MEDLINE Complete, CINAHL, APA PsycINFO, Communication Source and ERIC. Two reviewers will independently perform the title/abstract screening and the full-text screening with the exclusion criteria document being revised in an iterative process. Articles written in languages other than English will be excluded. Data will be extracted regarding key participant and intervention criteria, including technique dosage and delivery details. This information will then be pooled into a structured narrative synthesis. ETHICS AND DISSEMINATION: Ethical approval is not needed for a systematic review protocol. Dissemination of findings will be through peer-reviewed publications, social media, and project steering group networks. PROSPERO REGISTRATION NUMBER: CRD4202237393.

Barriers and enablers to diabetic retinopathy screening: a cross-sectional survey of young adults with type 1 and type 2 diabetes in the UK.

INTRODUCTION: Diabetic retinopathy screening (DRS) attendance in young adults (YAs) is consistently below recommended levels. The aim of this study was to identify barriers and enablers of DRS attendance among YAs in the UK living with type 1 (T1D) and type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS: YAs (18-34 years) were invited to complete an anonymous online survey in June 2021 assessing agreement with 30 belief statements informed by the Theoretical Domains Framework (TDF) of behavior change describing potential barriers/enablers to DRS. RESULTS: In total, 102 responses were received. Most had T1D (65.7%) and were regular attenders for DRS (76.5%). The most salient TDF domains for DRS attendance were 'Goals', with 93% agreeing that DRS was a high priority, and 'Knowledge', with 98% being aware that screening can detect eye problems early.Overall, 67.4% indicated that they would like greater appointment flexibility (Environmental context/resources) and 31.3% reported difficulties getting time off work/study to attend appointments (Environmental context/resources). This was more commonly reported by occasional non-attenders versus regular attenders (59.1% vs 23.4%, p=0.002). Most YAs were worried about diabetic retinopathy (74.3%), anxious when receiving screening results (63%) (Emotion) and would like more support after getting their results (66%) (Social influences). Responses for T1D and T2D were broadly similar, although those with T2D were more likely have developed strategies to help them to remember their appointments (63.6% vs 37.9%, p=0.019) (Behavioral regulation). CONCLUSIONS: Attendance for DRS in YAs is influenced by complex interacting behavioral factors. Identifying modifiable determinants of behavior will provide a basis for designing tailored interventions to improve DRS in YAs and prevent avoidable vision loss.

Selecting intervention content to target barriers and enablers of recognition and response to deteriorating patients: an online nominal group study.

BACKGROUND: Patients who deteriorate in hospital wards without appropriate recognition and/or response are at risk of increased morbidity and mortality. Track-and-trigger tools have been implemented internationally prompting healthcare practitioners (typically nursing staff) to recognise physiological changes (e.g. changes in blood pressure, heart rate) consistent with patient deterioration, and then to contact a practitioner with expertise in management of acute/critical illness. Despite some evidence these tools improve patient outcomes, their translation into clinical practice is inconsistent internationally. To drive greater guideline adherence in the use of the National Early Warning Score tool (a track-and-trigger tool used widely in the United Kingdom and parts of Europe), a theoretically informed implementation intervention was developed (targeting nursing staff) using the Theoretical Domains Framework (TDF) version 2 and a taxonomy of Behaviour Change Techniques (BCTs). METHODS: A three-stage process was followed: 1. TDF domains representing important barriers and enablers to target behaviours derived from earlier published empirical work were mapped to appropriate BCTs; 2. BCTs were shortlisted using consensus approaches within the research team; 3. shortlisted BCTs were presented to relevant stakeholders in two online group discussions where nominal group techniques were applied. Nominal group participants were healthcare leaders, senior clinicians, and ward-based nursing staff. Stakeholders individually generated concrete strategies for operationalising shortlisted BCTs ('applications') and privately ranked them according to acceptability and feasibility. Ranking data were used to drive decision-making about intervention content. RESULTS: Fifty BCTs (mapped in stage 1) were shortlisted to 14 (stage 2) and presented to stakeholders in nominal groups (stage 3) alongside example applications. Informed by ranking data from nominal groups, the intervention was populated with 12 BCTs that will be delivered face-to-face, to individuals and groups of nursing staff, through 18 applications. CONCLUSIONS: A description of a theory-based behaviour change intervention is reported, populated with BCTs and applications generated and/or prioritised by stakeholders using replicable consensus methods. The feasibility of the proposed intervention should be tested in a clinical setting and the content of the intervention elaborated further to permit replication and evaluation.

Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions.

BACKGROUND: The theoretical framework of acceptability (TFA) was developed in response to recommendations that acceptability should be assessed in the design, evaluation and implementation phases of healthcare interventions. The TFA consists of seven component constructs (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy) that can help to identify characteristics of interventions that may be improved. The aim of this study was to develop a generic TFA questionnaire that can be adapted to assess acceptability of any healthcare intervention. METHODS: Two intervention-specific acceptability questionnaires based on the TFA were developed using a 5-step pre-validation method for developing patient-reported outcome instruments: 1) item generation; 2) item de-duplication; 3) item reduction and creation; 4) assessment of discriminant content validity against a pre-specified framework (TFA); 5) feedback from key stakeholders. Next, a generic TFA-based questionnaire was developed and applied to assess prospective and retrospective acceptability of the COVID-19 vaccine. A think-aloud method was employed with two samples: 10 participants who self-reported intention to have the COVID-19 vaccine, and 10 participants who self-reported receiving a first dose of the vaccine. RESULTS: 1) The item pool contained 138 items, identified from primary papers included in an overview of reviews. 2) There were no duplicate items. 3) 107 items were discarded; 35 new items were created to maximise coverage of the seven TFA constructs. 4) 33 items met criteria for discriminant content validity and were reduced to two intervention-specific acceptability questionnaires, each with eight items. 5) Feedback from key stakeholders resulted in refinement of item wording, which was then adapted to develop a generic TFA-based questionnaire. For prospective and retrospective versions of the questionnaire, no participants identified problems with understanding and answering items reflecting four TFA constructs: affective attitude, burden, perceived effectiveness, opportunity costs. Some participants encountered problems with items reflecting three constructs: ethicality, intervention coherence, self-efficacy. CONCLUSIONS: A generic questionnaire for assessing intervention acceptability from the perspectives of intervention recipients was developed using methods for creating participant-reported outcome measures, informed by theory, previous research, and stakeholder input. The questionnaire provides researchers with an adaptable tool to measure acceptability across a range of healthcare interventions.

Barriers and enablers to diabetic eye screening attendance: An interview study with young adults with type 1 diabetes.

AIM: The aim of this study was to identify barriers and enablers of diabetic eye screening (DES) attendance amongst young adults with diabetes living in the United Kingdom. METHODS: Semistructured qualitative interviews with adults aged 18-34 years with diabetes. Participants were purposively sampled to aim for representation across gender, geographical locations, diabetes type, years since diabetes diagnosis and patterns of attendance (i.e. regular attenders, occasional non-attenders, regular non-attenders). Data were collected and analysed using the Theoretical Domains Framework (TDF) to explore potential individual, sociocultural and environmental influences on attendance. Data were analysed using a combined deductive and inductive thematic analysis approach. Barriers/enablers were mapped to behaviour change techniques (BCTs) to identify potential strategies to increase attendance. RESULTS: Key barriers to attendance reported by the sample of 29 study participants with type 1 diabetes, fell within the TDF domains: [Knowledge] (e.g. not understanding reasons for attending DES or treatments available if diabetic retinopathy is detected), [Social Influences] (e.g. lack of support following DES results), [Social role and Identity] (e.g. not knowing other people their age with diabetes, feeling 'isolated' and being reluctant to disclose their diabetes) and [Environmental Context and Resources] (e.g. lack of appointment flexibility and options for rescheduling). Enablers included: [Social Influences] (e.g. support of family/diabetes team), [Goals] (e.g. DES regarded as 'high priority'). Many of the reported barriers/enablers were consistent across groups. Potential BCTs to support attendance include Instructions on how to perform the behaviour; Information about health consequences; Social support (practical) and Social comparison. CONCLUSIONS: Attendance to diabetic eye screening in young adults is influenced by a complex set of interacting factors. Identification of potentially modifiable target behaviours provides a basis for designing more effective, tailored interventions to help young adults regularly attend eye screening and prevent avoidable vision loss.

Impact of fan therapy during exercise on breathlessness and recovery time in patients with COPD: a pilot randomised controlled crossover trial.

BACKGROUND: Patients with COPD reduce physical activity to avoid the onset of breathlessness. Fan therapy can reduce breathlessness at rest, but the efficacy of fan therapy during exercise remains unknown in this population. The aim of the present study was to investigate 1) the effect of fan therapy on exercise-induced breathlessness and post-exercise recovery time in patients with COPD and 2) the acceptability of fan therapy during exercise; and 3) to assess the reproducibility of any observed improvements in outcome measures. METHODS: A pilot single-centre, randomised, controlled, crossover open (nonmasked) trial (clinicaltrials.gov NCT03137524) of fan therapy versus no fan therapy during 6-min walk test (6MWT) in patients with COPD and a modified Medical Research Council (mMRC) dyspnoea score ≥2. Breathlessness intensity was quantified before and on termination of the 6MWT, using the numerical rating scale (NRS) (0-10). Post-exertional recovery time was measured, defined as the time taken to return to baseline NRS breathlessness score. Oxygen saturation and heart rate were measure pre- and post-6MWT. RESULTS: 14 patients with COPD completed the trial per protocol (four male, 10 female; median (interquartile range (IQR)) age 66.50 (60.75 to 73.50) years); mMRC dyspnoea 3 (2 to 3)). Fan therapy resulted in lower exercise-induced breathlessness (ΔNRS; Δ modified Borg scale) (within-individual differences in medians (WIDiM) -1.00, IQR -2.00 to -0.50; p<0.01; WIDiM -0.25, IQR -2.00 to 0.00; p=0.02), greater distance walked (metres) during the 6MWT (WIDiM 21.25, IQR 12.75 to 31.88; p<0.01), and improved post-exertional breathlessness (NRS) recovery time (WIDiM -10.00, IQR -78.75 to 50.00; p<0.01). Fan therapy was deemed to be acceptable by 92% of participants. CONCLUSION: Fan therapy was acceptable and provided symptomatic relief to patients with COPD during exercise. These data will inform larger pilot studies and efficacy studies of fan therapy during exercise.

Perceived barriers and enablers to the provision of diabetic retinopathy screening for young adults: a cross-sectional survey of healthcare professionals working in the UK National Diabetic Eye Screening Programme.

INTRODUCTION: Diabetic retinopathy screening (DRS) attendance in young adults is consistently below recommended levels. The aim of this study was to conduct a survey of screening providers in the UK Diabetic Eye Screening Programme (DESP) to identify perceived barriers and enablers to DRS attendance in young adults and elicit views on the effectiveness of strategies to improve screening uptake in this population. RESEARCH DESIGN AND METHODS: Members of the British Association of Retinal Screening (n=580) were invited to complete an anonymous online survey in July 2020 assessing agreement with 37 belief statements, informed by the Theoretical Domains Framework (TDF) of behavior change, describing potential barrier/enablers to delivering DRS for young adults and further survey items exploring effectiveness of strategies to improve uptake of DRS. RESULTS: In total, 140 (24%) responses were received mostly from screener/graders (67.1%). There was a high level of agreement that the DESP had a role in improving attendance in young adults (96.4%) and that more could be done to improve attendance (90.0%). The most commonly reported barriers related to TDF domains Social influences and Environmental context and resources including lack of integration of DRS with other processes of diabetes care, which limited the ability to discuss diabetes self-management. Other barriers included access to screening services and difficulties with scheduling appointments. Less than half (46.4%) of respondents reported having a dedicated strategy to improve screening uptake in young adults. Strategies perceived to be effective included: screening within the community; prompts/reminders and integrating eye screening with other diabetes services. CONCLUSIONS: Screening providers were concerned about screening uptake in young adults, although many programs lacked a dedicated strategy to improve attendance. Problems associated with a lack of integration between DRS with other diabetes care processes were identified as a major barrier to providing holistic care to young adults and supporting diabetes self-management.

Barriers and enablers of recognition and response to deteriorating patients in the acute hospital setting: A theory-driven interview study using the Theoretical Domains Framework.

AIM: To explore barriers and enablers of recognition and response to signs of patient deterioration by nursing staff in an acute hospital. DESIGN: A theory-driven interview study underpinned by the Theoretical Domains Framework of behaviour change. METHODS: Between 07/01/2019 and 18/12/2019 a purposive sample of registered nurses and healthcare assistants was recruited to participate in a semi-structured (audio-recorded) interview, to explore the determinants of seven specified behaviours of the afferent limb. Anonymised transcripts were deductively coded (using the 14 Theoretical Domains Framework domains as coding categories) and then extracts within each domain were inductively analysed to synthesise belief statements and themes. Prioritisation criteria from published literature were applied. RESULTS: Thirty-two semi-structured interviews were conducted. From 1,888 quotes, 184 belief statements and 66 themes were synthesised. One hundred and forty-six belief statements, represented by 58 themes, met prioritisation criteria. Nine domains of the Theoretical Domains Framework were of high importance: Knowledge; Social, Professional Role and Identity; Beliefs about Consequences; Reinforcement; Intentions; Goals; Memory, Attention and Decision Processes; Environment, Context and Resources and Social Influences. CONCLUSIONS: Barriers and enablers most likely to impact on nursing staff afferent limb behaviour were identified in nine domains of the Theoretical Domains Framework.

Does prospective acceptability of an intervention influence refusal to participate in a randomised controlled trial? An interview study.

BACKGROUND: The generalizability of findings of Randomised Controlled Trials (RCTs) is undermined by low or biased recruitment. Reasons for participant refusal are infrequently reported in published literature. AIMS: To apply the Theoretical Framework of Acceptability (TFA) to: (1) explore patient-reported reasons for declining to participate in a RCT comparing a new service model (patient-initiated appointments) with standard care (appointments scheduled by clinician) for managing blepharospasm and hemifacial spasm; (2) to explore associations between decliners' perceptions of acceptability and non-participation. METHOD: Eligible patients (n = 242) were approached to participate in the trial. Phase 1: decliners provided a brief reason for refusal. Reasons were analysed descriptively and reviewed against TFA constructs. PHASE 2: Consecutive decliners participated in short semi-structured interviews, to explore their reasons for refusal in more depth. Interviews were transcribed and analysed, with the TFA as a coding framework. RESULTS: Eighty-seven (36%) eligible patients refused trial participation; all provided a reason. From interviews with 15 decliners (17%), four key beliefs about acceptability were identified: happy with standard care (n = 41) (49%), anticipated burden of patient-initiated service, lack of confidence in ability to engage with new service and uncertainties about effectiveness of new service. Two themes reflected non-TFA factors: trial participation a low priority and burden of completing trial documentation. CONCLUSION: Reasons for refusal trial participation included: (a) reasons directly associated with intervention acceptability, and (b) reasons associated with trial participation more broadly. The TFA facilitated identification of problematic aspects of the new appointment booking system which could be addressed to enhance acceptability.

Reasons for nonparticipation in the Valuing Active Life in Dementia randomised controlled trial of a dyadic occupational therapy intervention: An interview study.

OBJECTIVES: There is currently little known about why people decline to participate in dyadic, psychosocial dementia research. This interview study aims to explore the reasons why people declined to participate in the Valuing Active Life in Dementia research trial. METHODS: Ten family carers of people with dementia, who were part of a dyad that had declined to take part in the randomised controlled trial, participated in qualitative telephone interviews to explore their reasons for declining. Inductive thematic analysis was used to identify themes. FINDINGS: Two themes with related sub-themes were identified: (1) Protectiveness - protecting the person with dementia, themselves as carers and their current lifestyle; (2) 'It's not for us' - the time commitment, and the possible unsuitability of the intervention, was seen to outweigh the perceived benefit of taking part. People with dementia were not always involved in the decision-making process, with carers stating the decision not to participate was made in the usual way as all their decisions. No apparent differences between the spousal and the child carers were apparent in the small sample. CONCLUSION: Recruitment to randomised controlled trials can be considered difficult or unfair because some participants will miss out on the desired intervention. However, this study shows that concern about the time and inconvenience of being involved in the trial can put people off research participation. Identifying possible reasons for declining research participation contributes to the design of future trials and recruitment strategies, so that the potential benefit is considered relative to the time and effort involved. Offering research opportunities to people with dementia and their families at the right stage of the dementia trajectory for their needs, facilitating personalised recruitment strategies with finely tailored researcher communication skills should help maximise recruitment, reduce attrition and deliver a more successful trial.

Patterns of behaviour in nursing staff actioning the afferent limb of the rapid response system (RRS): A focused ethnography.

AIM: To improve understanding of afferent limb behaviour in acute hospital ward settings, to define and specify who needs to do what differently and to report what afferent limb behaviours should be targeted in a subsequent multi-phase, theory-based, intervention development process. DESIGN: Focused ethnography was used including direct observation of nursing staff enacting afferent limb behaviours and review of vital signs charts. METHODS: An observation guide focused observation on "key moments" of the afferent limb. Descriptions of observations from between 7 January 2019-18 December 2019 were recorded in a field journal alongside reflexive notes. Vital signs and early warning scores from charts were reviewed and recorded. Field notes were analysed using structured content analysis. Observed behaviour was compared with expected (policy-specified) behaviour. RESULTS: Observation was conducted for 300 hr. Four hundred and ninety-nine items of data (e.g., an episode of observation or a set of vital signs) were collected. Two hundred and eighty-nine (58%) items of data were associated with expected (i.e. policy-specified) afferent limb behaviour; 210 (42%) items of data were associated with unexpected afferent limb behaviour (i.e. alternative behaviour or no behaviour). Ten specific behaviours were identified where the behaviour observed deviated (negatively) from policy or where no action was taken when it should have been. One further behaviour was seen to expedite the assessment of a deteriorating patient by an appropriate responder and was therefore considered a positive deviance. CONCLUSION: Afferent limb failure has been described as a problem of inconsistent staff behaviour. Eleven potential target behaviours for change are reported and specified using a published framework. IMPACT: Clear specification of target behaviour will allow further enquiry into the determinants of these behaviours and the development of a theory-based intervention that is more likely to result in behaviour change and can be tested empirically in future research.

Recovery-focused mental health care planning and co-ordination in acute inpatient mental health settings: a cross national comparative mixed methods study.

BACKGROUND: Involving mental health service users in planning and reviewing their care can help personalised care focused on recovery, with the aim of developing goals specific to the individual and designed to maximise achievements and social integration. We aimed to ascertain the views of service users, carers and staff in acute inpatient wards on factors that facilitated or acted as barriers to collaborative, recovery-focused care. METHODS: A cross-national comparative mixed-methods study involving 19 mental health wards in six service provider sites in England and Wales. This included a survey using established standardised measures of service users (n = 301) and staff (n = 290) and embedded case studies involving interviews with staff, service users and carers (n = 76). Quantitative and qualitative data were analysed within and across sites using descriptive and inferential statistics, and framework method. RESULTS: For service users, when recovery-oriented focus was high, the quality of care was rated highly, as was the quality of therapeutic relationships. For staff, there was a moderate correlation between recovery orientation and quality of therapeutic relationships, with considerable variability. Staff members rated the quality of therapeutic relationships higher than service users did. Staff accounts of routine collaboration contrasted with a more mixed picture in service user accounts. Definitions and understandings of recovery varied, as did views of hospital care in promoting recovery. Managing risk was a central issue for staff, and service users were aware of measures taken to keep them safe, although their involvement in discussions was less apparent. CONCLUSIONS: There is positive practice within acute inpatient wards, with evidence of commitment to safe, respectful, compassionate care. Recovery ideas were evident but there remained ambivalence on their relevance to inpatient care. Service users were aware of efforts taken to keep them safe, but despite measures described by staff, they did not feel routinely involved in care planning or risk management decisions. Research on increasing therapeutic contact time, shared decision making in risk assessment and using recovery focused tools could further promote personalised and recovery-focused care planning. This paper arises from a larger study published by National Institute for Health Research (Simpson A, et al, Health Serv Deliv Res 5(26), 2017).

What utility scores do mental health service users, healthcare professionals and members of the general public attribute to different health states? A co-produced mixed methods online survey.

BACKGROUND: Utility scores are integral to health economics decision-making. Typically, utility scores have not been scored or developed with mental health service users. The aims of this study were to i) collaborate with service users to develop descriptions of five mental health states (psychosis, depression, eating disorder, medication side effects and self-harm); ii) explore feasibility and acceptability of using scenario-based health states in an e-survey; iii) evaluate which utility measures (standard gamble (SG), time trade off (TTO) and rating scale (RS)) are preferred; and iv) determine how different participant groups discriminate between the health scenarios and rank them. DESIGN AND METHODS: This was a co-produced mixed methods cross-sectional online survey. Utility scores were generated using the SG, TTO and RS methods; difficulty of the completing each method, markers of acceptability and participants' preference were also assessed. RESULTS: A total of 119 participants (58%) fully completed the survey. For any given health state, SG consistently generated higher utility scores compared to RS and for some health states higher also than TTO (i.e. SG produces inflated utility scores relative to RS and TTO). Results suggest that different utility measures produce different evaluations of described health states. The TTO was preferred by all participant groups over the SG. The three participant groups scored four (of five) health scenarios comparably. Psychosis scored as the worst health state to live with while medication side-effects were viewed more positively than other scenarios (depression, eating disorders, self-harm) by all participant groups. However, there was a difference in how the depression scenario was scored, with service users giving depression a lower utility score compared to other groups. CONCLUSION: Mental health state scenarios used to generate utility scores can be co-produced and are well received by a broad range of participants. Utility valuations using SG, TTO and RS were feasible for use with service users, carers, healthcare professionals and members of the general public. Future studies of utility scores in psychiatry should aim to include mental health service users as both co-investigators and respondents.

Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework.

BACKGROUND: It is increasingly acknowledged that 'acceptability' should be considered when designing, evaluating and implementing healthcare interventions. However, the published literature offers little guidance on how to define or assess acceptability. The purpose of this study was to develop a multi-construct theoretical framework of acceptability of healthcare interventions that can be applied to assess prospective (i.e. anticipated) and retrospective (i.e. experienced) acceptability from the perspective of intervention delivers and recipients. METHODS: Two methods were used to select the component constructs of acceptability. 1) An overview of reviews was conducted to identify systematic reviews that claim to define, theorise or measure acceptability of healthcare interventions. 2) Principles of inductive and deductive reasoning were applied to theorise the concept of acceptability and develop a theoretical framework. Steps included (1) defining acceptability; (2) describing its properties and scope and (3) identifying component constructs and empirical indicators. RESULTS: From the 43 reviews included in the overview, none explicitly theorised or defined acceptability. Measures used to assess acceptability focused on behaviour (e.g. dropout rates) (23 reviews), affect (i.e. feelings) (5 reviews), cognition (i.e. perceptions) (7 reviews) or a combination of these (8 reviews). From the methods described above we propose a definition: Acceptability is a multi-faceted construct that reflects the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention. The theoretical framework of acceptability (TFA) consists of seven component constructs: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy. CONCLUSION: Despite frequent claims that healthcare interventions have assessed acceptability, it is evident that acceptability research could be more robust. The proposed definition of acceptability and the TFA can inform assessment tools and evaluations of the acceptability of new or existing interventions.

A RCT of telehealth for COPD patient's quality of life: the whole system demonstrator evaluation.

INTRODUCTION/OBJECTIVES: Despite some concerns that the introduction of telehealth (TH) may lead to reductions in quality of life (QoL), lower mood and increased anxiety in response to using assistive technologies to reduce health care utilisation and manage long term conditions, this research focuses on the extent to which providing people with tools to monitor their condition can improve QoL. METHODS: The Chronic Obstructive Pulmonary Disease (COPD) cohort of the Whole Systems Demonstrator Trial is a pragmatic General Practitioner (GP) clustered randomised controlled trial (RCT) evaluating TH in the UK from three regions in England. All patients at a participating GP practice were deemed eligible for inclusion in the study if they were diagnosed with COPD. RESULTS: 447 participants completed baseline and either a short (4 months) or long term (12 months) follow-up. There was a trend of improved QoL and mood in the TH group at longer-term follow-up, but not short term follow-up. Emotional functioning (g = 0.280 95%CI, 0.051-0.510) and mastery reached (g = 2.979 95%CI, 0-0.46) significance at P < 0.05 (all Hedges g <0.3). CONCLUSIONS: TH showed minimal benefit to QoL in COPD patients who were not preselected to be at increased risk of acute exacerbations. Benefits were more likely in disease specific measures at longer term follow-up. TH is a complex intervention and should be embedded in a service that is evidenced based. Outcome measures must be sensitive enough to detect changes in the target population for the specific intervention.

Quantifying beliefs regarding telehealth: Development of the Whole Systems Demonstrator Service User Technology Acceptability Questionnaire.

Introduction Telehealth (TH) is a potential solution to the increased incidence of chronic illness in an ageing population. The extent to which older people and users with chronic conditions accept and adhere to using assistive technologies is a potential barrier to mainstreaming the service. This study reports the development and validation of the Whole Systems Demonstrator (WSD) Service User Technology Acceptability Questionnaire (SUTAQ). Methods Questionnaires measuring the acceptability of TH, quality of life, well-being and psychological processes were completed by 478 users of TH. The 22 acceptability items were subject to principal components analysis (PCA) to determine sub-scales. Scale scores, relationships between scales and other patient-reported outcome measures (PROMs), and group differences on scales were utilised to check the reliability and validity of the measure. Results PCAs of SUTAQ items produced six TH acceptability scales: enhanced care, increased accessibility, privacy and discomfort, care personnel concerns, kit as substitution and satisfaction. Significant correlations within these beliefs and between these scales and additional PROMs were coherent, and the SUTAQ sub-scales were able to predict those more likely to refuse TH. Discussion The SUTAQ is an instrument that can be used to measure user beliefs about the acceptability of TH, and has the ability to discriminate between groups and predict individual differences in beliefs and behaviour. Measuring acceptability beliefs of TH users can provide valuable information to direct and target provision of services to increase uptake and maintain use of TH.

The Effect of Telehealth on Quality of Life and Psychological Outcomes Over a 12-Month Period in a Diabetes Cohort Within the Whole Systems Demonstrator Cluster Randomized Trial.

BACKGROUND: Much is written about the promise of telehealth and there is great enthusiasm about its potential. However, many studies of telehealth do not meet orthodox quality standards and there are few studies examining quality of life in diabetes as an outcome. OBJECTIVE:  To assess the impact of home-based telehealth (remote monitoring of physiological, symptom and self-care behavior data for long-term conditions) on generic and disease-specific health-related quality of life, anxiety, and depressive symptoms over 12 months in patients with diabetes. Remote monitoring provides the potential to improve quality of life, through the reassurance it provides patients. METHODS: The study focused on participant-reported outcomes of patients with diabetes within the Whole Systems Demonstrator (WSD) Telehealth Questionnaire Study, nested within a pragmatic cluster-randomized trial of telehealth (the WSD Telehealth Trial), held across 3 regions of England. Telehealth was compared with usual-care, with general practice as the unit of randomization. Participant-reported outcome measures (Short-Form 12, EuroQual-5D, Diabetes Health Profile scales, Brief State-Trait Anxiety Inventory, and Centre for Epidemiological Studies Depression Scale) were collected at baseline, short-term (4 months) and long-term (12months) follow-ups. Intention-to-treat analyses testing treatment effectiveness, were conducted using multilevel models controlling for practice clustering and a range of covariates. Analyses assumed participants received their allocated treatment and were conducted for participants who completed the baseline plus at least one follow-up assessment (n=317). RESULTS:  Primary analyses showed differences between telehealth and usual care were small and only reached significance for 1 scale (diabetes health profile-disinhibited eating, P=.006). The magnitude of differences between trial arms did not reach the trial-defined minimal clinically important difference of 0.3 standard deviations for most outcomes. Effect sizes (Hedge's g) ranged from 0.015 to 0.143 for Generic quality of life (QoL) measures and 0.018 to 0.394 for disease specific measures. CONCLUSIONS: Second generation home-based telehealth as implemented in the WSD evaluation was not effective in the subsample of people with diabetes. Overall, telehealth did not improve or have a deleterious effect quality of life or psychological outcomes for patients with diabetes over a 12-month period.