Lee Silverman voice treatment versus NHS speech and language therapy versus control for dysarthria in people with Parkinson's disease (PD COMM): pragmatic, UK based, multicentre, three arm, parallel group, unblinded, randomised controlled trial.

OBJECTIVES: To assess the clinical effectiveness of two speech and language therapy approaches versus no speech and language therapy for dysarthria in people with Parkinson's disease. DESIGN: Pragmatic, UK based, multicentre, three arm, parallel group, unblinded, randomised controlled trial. SETTING: The speech and language therapy interventions were delivered in outpatient or home settings between 26 September 2016 and 16 March 2020. PARTICIPANTS: 388 people with Parkinson's disease and dysarthria. INTERVENTIONS: Participants were randomly assigned to one of three groups (1:1:1): 130 to Lee Silverman voice treatment (LSVT LOUD), 129 to NHS speech and language therapy, and 129 to no speech and language therapy. LSVT LOUD consisted of four, face-to-face or remote, 50 min sessions each week delivered over four weeks. Home based practice activities were set for up to 5-10 mins daily on treatment days and 15 mins twice daily on non-treatment days. Dosage for the NHS speech and language therapy was determined by the local therapist in response to the participants' needs (estimated from prior research that NHS speech and language therapy participants would receive an average of one session per week over six to eight weeks). Local practices for NHS speech and language therapy were accepted, except for those within the LSVT LOUD protocol. Analyses were based on the intention to treat principle. MAIN OUTCOME MEASURES: The primary outcome was total score at three months of self-reported voice handicap index. RESULTS: People who received LSVT LOUD reported lower voice handicap index scores at three months after randomisation than those who did not receive speech and language therapy (-8.0 points (99% confidence interval -13.3 to -2.6); P<0.001). No evidence suggests a difference in voice handicap index scores between NHS speech and language therapy and no speech and language therapy (1.7 points (-3.8 to 7.1); P=0.43). Patients in the LSVT LOUD group also reported lower voice handicap index scores than did those randomised to NHS speech and language therapy (-9.6 points (-14.9 to -4.4); P<0.001). 93 adverse events (predominately vocal strain) were reported in the LSVT LOUD group, 46 in the NHS speech and language therapy group, and none in the no speech and language therapy group. No serious adverse events were recorded. CONCLUSIONS: LSVT LOUD was more effective at reducing the participant reported impact of voice problems than was no speech and language therapy and NHS speech and language therapy. NHS speech and language therapy showed no evidence of benefit compared with no speech and language therapy. TRIAL REGISTRATION: ISRCTN registry ISRCTN12421382.

Identifying key health system components associated with improved outcomes to inform the re-configuration of services for adults with rare autoimmune rheumatic diseases: a mixed-methods study.

BACKGROUND: Adults with rare autoimmune rheumatic diseases face unique challenges and struggles to navigate health-care systems designed to manage common conditions. Evidence to inform an optimal service framework for their care is scarce. Using systemic vasculitis as an exemplar, we aimed to identify and explain the key service components underpinning effective care for rare diseases. METHODS: In this mixed-methods study, data were collected as part of a survey of vasculitis service providers across the UK and Ireland, interviews with patients, and from organisational case studies to identify key service components that enable good care. The association between these components and patient outcomes (eg, serious infections, mortality) and provider outcomes (eg, emergency hospital admissions) were examined in a population-based data linkage study using routine health-care data obtained from patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis from national health datasets in Scotland. We did univariable and multivariable analyses using Bayesian poisson and negative binomial regression to estimate incident rate ratios (IRRs), and Cox proportional hazards models to estimate hazard ratios (HRs). People with lived experiences were involved in the research and writing process. FINDINGS: Good care was characterised by service components that supported timely access to services, integrated care, and expertise. In 1420 patients with ANCA-associated vasculitis identified from national health datasets, service-reported average waiting times for new patients of less than 1 week were associated with fewer serious infections (IRR 0·70 [95% credibility interval 0·55-0·88]) and fewer emergency hospital admissions (0·78 [0·68-0·92]). Nurse-led advice lines were associated with fewer serious infections (0·76 [0·58-0·93]) and fewer emergency hospital admissions (0·85 [0·74-0·96]). Average waiting times for new patients of less than 1 week were also associated with reduced mortality (HR 0·59 [95% credibility interval 0·37-0·93]). Cohorted clinics, nurse-led clinics, and specialist vasculitis multi-disciplinary team meetings were associated with fewer serious infections (IRR 0·75 [0·59-0·96] for cohorted clinics; 0·65 [0·39-0·84] for nurse-led clinics; 0·72 [0·57-0·90] for specialist vasculitis multi-disciplinary team meetings) and emergency hospital admissions (0·81 [0·71-0·91]; 0·75 [0·65-0·94]; 0·86 [0·75-0·96]). Key components were characterised by their ability to overcome professional tensions between specialties. INTERPRETATION: Key service components associated with important health outcomes and underpinning factors were identified to inform initiatives to improve the design, delivery, and effectiveness of health-care models for rare autoimmune rheumatic diseases. FUNDING: Versus Arthritis.

Understanding capacity for implementing new interventions: A qualitative study of speech and language therapy services for children with speech sound disorder.

BACKGROUND: Many speech sound disorder (SSD) interventions with a long-term evidence base are 'new' to clinical practice, and the role of services in supporting or constraining capacity for practice change is underexplored. Innovations from implementation science may offer solutions to this research-practice gap but have not previously been applied to SSD. AIM: To explain variation in speech and language therapy service capacity to implement new SSD interventions. METHODS & PROCEDURES: We conducted an intensive, case-based qualitative study with 42 speech and language therapists (SLTs) in three NHS services (n = 39) and private practice (n = 3) in Scotland. We explored therapists' diverse experiences of SSD practice change through individual interviews (n = 28) or self-generated paired (n = 2) or focus groups (n = 3). A theoretical framework (Normalization Process Theory) helped us understand how the service context contributed to the way therapists engaged with different practice changes. OUTCOMES & RESULTS: We identified six types ('cases') of practice change, two of which involved the new SSD interventions. We focus on these two cases ('Transforming' and 'Venturing') and use Normalization Process Theory's Cognitive participation construct to explain implementation (or not) of new SSD interventions in routine practice. Therapists were becoming aware of the new interventions through knowledge brokers, professional networks and an intervention database. In the Transforming case, new SSD interventions for selected children were becoming part of local routine practice. Transforming was the result of a favourable service structure, a sustained and supported 'push' that made implementation of the new interventions a service priority, and considerable collective time to think about doing it. 'Venturing' happened where the new SSD interventions were not a service priority. It involved individual or informal groups of therapists trying out or using one or more of the new interventions with selected children within the constraints of their service context. CONCLUSIONS & IMPLICATIONS: New, evidence-based SSD interventions may be challenging to implement in routine practice because they have in common a need for therapists who understand applied linguistics and can be flexible with service delivery. Appreciating what it really takes to do routine intervention differently is vital for managers and services who have to make decisions about priorities for implementation, along with realistic plans for resourcing and supporting it. WHAT THIS PAPER ADDS: What is already known on the subject Many SSD interventions have an evidence base but are not widely adopted into routine clinical practice. Addressing this is not just about individual therapists or education/training, as workplace pressures and service delivery models make it difficult to change practice. What this paper adds to the existing knowledge This paper applies innovations from implementation science to help explain how what is going on in services can support or constrain capacity for implementing evidence-based SSD interventions. What are the potential or actual clinical implications of this work? Service managers and therapists will have a clearer idea of the time and support they may realistically have to invest for new SSD interventions to be used routinely.

Achieving 'coherence' in routine practice: a qualitative case-based study to describe speech and language therapy interventions with implementation in mind.

BACKGROUND: Implementation depends on healthcare professionals being able to make sense of a new intervention in relation to their routine practice. Normalisation Process Theory refers to this as coherence work. However, specifying what it takes to achieve coherence is challenging because of variations in new interventions, routine practices and the relationship between them. Frameworks for intervention description may offer a way forward, as they provide broad descriptive categories for comparing complex interventions. To date such frameworks have not been informed by implementation theory, so do not account for the coherence work involved in holding aspects of routine practice constant while doing other aspects differently. Using speech and language therapy as an empirical exemplar, we explored therapists' experiences of practice change and developed a framework to show how coherence of child speech interventions is achieved. METHODS: We conducted a retrospective case-based qualitative study of how interventions for child speech problems had changed across three NHS speech and language therapy services and private practice in Scotland. A coherence framework was derived through interplay between empirical work with 42 therapists (using in-depth interviews, or self-organised pairs or small focus groups) and Normalisation Process Theory's construct of coherence. FINDINGS: Therapists reported a range of practice changes, which had demanded different types of coherence work. Non-traditional interventions had featured for many years in the profession's research literature but not in clinical practice. Achieving coherence with these interventions was intellectually demanding because they challenged the traditional linguistic assumptions underpinning routine practice. Implementation was also logistically demanding, and therapists felt they had little agency to vary what was locally conventional for their service. In addition, achieving coherence took considerable relational work. Non-traditional interventions were often difficult to explain to children and parents, involved culturally uncomfortable repetitive drills and required therapists to do more tailoring of intervention for individual children. CONCLUSIONS: The intervention coherence framework has practical and theoretical applications. It is designed to help therapists, services and researchers anticipate and address barriers to achieving coherence when implementing non-routine interventions. It also represents a worked example of using theory to make intervention description both user-focused and implementation-friendly.

The barriers and facilitators influencing the sustainability of hospital-based interventions: a systematic review.

BACKGROUND: Identifying factors that influence sustained implementation of hospital-based interventions is key to ensuring evidence-based best practice is maintained across the NHS. This study aimed to identify, appraise and synthesise the barriers and facilitators that influenced the delivery of sustained healthcare interventions in a hospital-based setting. METHODS: A systematic review reported in accordance with PRISMA. Eight electronic databases were reviewed in addition to a hand search of Implementation Science journal and reference lists of included articles. Two reviewers were used to screen potential abstracts and full text papers against a selection criteria. Study quality was also independently assessed by two reviewers. Barriers and facilitators were extracted and mapped to a consolidated sustainability framework. RESULTS: Our searching identified 154,757 records. We screened 14,626 abstracts and retrieved 431 full text papers, of which 32 studies met the selection criteria. The majority of studies employed a qualitative design (23/32) and were conducted in the UK (8/32) and the USA (8/32). Interventions or programmes were all multicomponent, with the majority aimed at improving the quality of patient care and/ or safety (22/32). Sustainability was inconsistently reported across 30 studies. Barriers and facilitators were reported in all studies. The key facilitators included a clear accountability of roles and responsibilities (23/32); ensuring the availability of strong leadership and champions advocating the use of the intervention (22/32), and provision of adequate support available at an organisational level (21/32). The most frequently reported barrier to sustainability was inadequate staff resourcing (15/32). Our review also identified the importance of inwards spread and development of the initiative over time, as well as the unpredictability of sustainability and the need for multifaceted approaches. CONCLUSIONS: This review has important implications for practice and research as it increases understanding of the factors that faciliate and hinder intervention sustainability. It also highlights the need for more consistent and complete reporting of sustainability to ensure that lessons learned can be of direct benefit to future implementation of interventions. TRIAL REGISTRATION: The review is registered on PROSPERO ( CRD42017081992 ).

Recruitment challenges in stroke rehabilitation randomized controlled trials: a qualitative exploration of trialists' perspectives using Framework analysis.

OBJECTIVE: To explore the underlying reasons for recruitment difficulties to stroke rehabilitation randomized controlled trials from the perspective of trialists. DESIGN: A qualitative study using semi-structured interviews and Framework analysis. PARTICIPANTS: Twenty multidisciplinary stroke rehabilitation trialists across 13 countries with a range of clinical and research experience. METHODS: Twenty semi-structured telephone interviews were carried out. Purposeful sampling ensured a range of opinions were gathered from across the international stroke rehabilitation research community. Using Framework analysis, the analytical framework was formed by three researchers and tested before being applied to the total dataset. RESULTS: Three themes described the trialists' perception of the underlying reasons for recruitment difficulties: (i) decision making, (ii) importance of recruiters and (iii) a broken system. Trialists described frequently disregarding evidence in favour of prior research experiences when planning randomized controlled trial recruitment. All felt that the relationship between the research and clinical teams was vital to ensure recruiters prioritized and found value in recruitment to the trial. Experienced trialists were frustrated by the lack of reporting of the reality of running trials, research governance demands and the feeling that they had to deliberately underestimate recruitment timeframes to secure funding. CONCLUSION: Stroke rehabilitation trialists described recruitment difficulties which may be related to their experiential based recruitment decision making, a lack of understanding of how best to incentivize and maintain relationships with recruiters and unrealistic bureaucratic expectations both in terms of gaining funding and research governance.

Improving the sustainability of hospital-based interventions: a study protocol for a systematic review.

INTRODUCTION: Sustaining effective interventions in hospital environments is essential to improving health outcomes, and reducing research waste. Current evidence suggests many interventions are not sustained beyond their initial delivery. The reason for this failure remains unclear. Increasingly research is employing theoretical frameworks and models to identify critical factors that influence the implementation of interventions. However, little is known about the value of these frameworks on sustainability. The aim of this review is to examine the evidence regarding the use of theoretical frameworks to maximise effective intervention sustainability in hospital-based settings in order to better understand their role in supporting long-term intervention use. METHODS AND ANALYSIS: Systematic review. We will systematically search the following databases: Medline, AMED, CINAHL, Embase and Cochrane Library (CENTRAL, CDSR, DARE, HTA). We will also hand search relevant journals and will check the bibliographies of all included studies. Language and date limitations will be applied. We will include empirical studies that have used a theoretical framework (or model) and have explicitly reported the sustainability of an intervention (or programme). One reviewer will remove obviously irrelevant titles. The remaining abstracts and full-text articles will be screened by two independent reviewers to determine their eligibility for inclusion. Disagreements will be resolved by discussion, and may involve a third reviewer if required. Key study characteristics will be extracted (study design, population demographics, setting, evidence of sustained change, use of theoretical frameworks and any barriers or facilitators data reported) by one reviewer and cross-checked by another reviewer. Descriptive data will be tabulated within evidence tables, and key findings will be brought together within a narrative synthesis. ETHICS AND DISSEMINATION: Formal ethical approval is not required as no primary data will be collected. Dissemination of results will be through peer-reviewed journal publications, presentation at an international conference and social media. PROSPERO REGISTRATION NUMBER: CRD42017081992.

The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson's disease.

BACKGROUND: The PD COMM trial is a phase III multi-centre randomised controlled trial whose aim is to evaluate the effectiveness and cost-effectiveness of two approaches to speech and language therapy (SLT) compared with no SLT intervention (control) for people with Parkinson's disease who have self-reported or carer-reported problems with their speech or voice. Our protocol describes the process evaluation embedded within the outcome evaluation whose aim is to evaluate what happened at the time of the PD COMM intervention implementation and to provide findings that will assist in the interpretation of the PD COMM trial results. Furthermore, the aim of the PD COMM process evaluation is to investigate intervention complexity within a theoretical model of how the trialled interventions might work best and why. METHODS/DESIGN: Drawing from the Normalization Process Theory and frameworks for implementation fidelity, a mixed method design will be used to address process evaluation research questions. Therapists' and participants' perceptions and experiences will be investigated via in-depth interviews. Critical incident reports, baseline survey data from therapists, treatment record forms and home practice diaries also will be collected at relevant time points throughout the running of the PD COMM trial. Process evaluation data will be analysed independently of the outcome evaluation before the two sets of data are then combined. DISCUSSION: To date, there are a limited number of published process evaluation protocols, and few are linked to trials investigating rehabilitation therapies. Providing a strong theoretical framework underpinning design choices and being tailored to meet the complex characteristics of the trialled interventions, our process evaluation has the potential to provide valuable insight into which components of the interventions being delivered in PD COMM worked best (and what did not), how they worked well and why. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN12421382 . Registered on 18 April 2016.

Delivery of alcohol brief interventions in community-based youth work settings: exploring feasibility and acceptability in a qualitative study.

BACKGROUND: Alcohol Brief Interventions (ABIs) are increasingly being delivered in community-based youth work settings. However, little attention has been paid to how they are being implemented in such settings, or to their feasibility and acceptability for practitioners or young people. The aim of this qualitative study was to explore the context, feasibility and acceptability of ABI delivery in youth work projects across Scotland. METHODS: Individual, paired and group interviews were conducted with practitioners and young people in nine community projects that were either involved in the delivery of ABIs or were considering doing so in the near future. A thematic analysis approach was used to analyse data. RESULTS: ABIs were delivered in a diverse range of youth work settings including the side of football pitches, on the streets as part of outreach activities, and in sexual health drop-in centres for young people. ABI delivery differed in a number of important ways from delivery in other health settings such as primary care, particularly in being largely opportunistic and flexible in nature. ABIs were adapted by staff in line with the ethos of their project and their own roles, and to avoid jeopardising their relationships with young people. Young people reacted positively to the idea of having conversations about alcohol with youth project workers, but confirmed practitioners' views about the importance of these conversations taking place in the context of an existing trusting relationship. CONCLUSION: ABIs were feasible in a range of youth work settings with some adaptation. Acceptability to staff was strongly influenced by perceived benefits, and the extent to which ABIs fitted with their project's ethos. Young people were largely comfortable with such conversations. Future implementation efforts should be based on detailed consideration of current practice and contexts. Flexible models of delivery, where professional judgement can be exercised over defined but adaptable content, may be better appreciated by staff and encourage further development of ABI activity.

Adolescents' awareness of cancer risk factors and associations with health-related behaviours.

Increasing adolescents' awareness of the contribution of modifiable lifestyle factors to cancer risk may influence life-long patterns of healthy behaviour. However, little is known about adolescents' awareness of cancer risk factors and the effectiveness of awareness-raising interventions. This study assessed adolescents' cancer awareness and the effectiveness of an existing cancer-specific school-based intervention delivered by Teenage Cancer Trust. The Cancer Awareness Measure was completed by 478 adolescents (male: 250, 52.3%) aged 11-17 years (mean: 13.8, standard deviation: 1.24) in four UK schools; 422 adolescents provided paired data 2 weeks before and 2 weeks after the intervention delivered in 3 schools, and twice 4 weeks apart in the fourth (control) school. Adolescents recognized on average 4.4 (of 11) cancer risk factors. With the exception of smoking, adolescents' awareness of cancer risk factors was low. Awareness significantly increased after the intervention (4.6-5.7, P < 0.001). There was no significant change in the control school. Intervention effect was greater among females. This educational intervention is an effective way to raise adolescents' awareness of cancer risk factors. However, further cross-sectional and experimental studies are required to definitively assess adolescents' awareness of cancer risk factors and the effectiveness of this educational intervention.