Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of oesophageal varices: study protocol for a randomised controlled trial.

BACKGROUND: Liver disease is within the top five causes of premature death in adults. Deaths caused by complications of cirrhosis continue to rise, whilst deaths related to other non-liver disease areas are declining. Portal hypertension is the primary sequelae of cirrhosis and is associated with the development of variceal haemorrhage, ascites, hepatic encephalopathy and infection, collectively termed hepatic decompensation, which leads to hospitalisation and mortality. It remains uncertain whether administering a non-selective beta-blocker (NSBB), specifically carvedilol, at an earlier stage, i.e. when oesophageal varices are small, can prevent VH and reduce all-cause decompensation (ACD). METHODS/DESIGN: The BOPPP trial is a pragmatic, multicentre, placebo-controlled, triple-blinded, randomised controlled trial (RCT) in England, Scotland, Wales and Northern Ireland. Patients aged 18 years or older with cirrhosis and small oesophageal varices that have never bled will be recruited, subject to exclusion criteria. The trial aims to enrol 740 patients across 55 hospitals in the UK. Patients are allocated randomly on a 1:1 ratio to receive either carvedilol 6.25 mg (a NSBB) or a matched placebo, once or twice daily, for 36 months, to attain adequate power to determine the effectiveness of carvedilol in preventing or reducing ACD. The primary outcome is the time to first decompensating event. It is a composite primary outcome made up of variceal haemorrhage (VH, new or worsening ascites, new or worsening hepatic encephalopathy (HE), spontaneous bacterial peritonitis (SBP), hepatorenal syndrome, an increase in Child-Pugh grade by 1 grade or MELD score by 5 points, and liver-related mortality. Secondary outcomes include progression to medium or large oesophageal varices, development of gastric, duodenal, or ectopic varices, participant quality of life, healthcare costs and transplant-free survival. DISCUSSION: The BOPPP trial aims to investigate the clinical and cost-effectiveness of carvedilol in patients with cirrhosis and small oesophageal varices to determine whether this non-selective beta-blocker can prevent or reduce hepatic decompensation. There is clinical equipoise on whether intervening in cirrhosis, at an earlier stage of portal hypertension, with NSBB therapy is beneficial. Should the trial yield a positive result, we anticipate that the administration and use of carvedilol will become widespread with pathways developed to standardise the administration of the medication in primary care. ETHICS AND DISSEMINATION: The trial has been approved by the National Health Service (NHS) Research Ethics Committee (REC) (reference number: 19/YH/0015). The results of the trial will be submitted for publication in a peer-reviewed scientific journal. Participants will be informed of the results via the BOPPP website ( www.boppp-trial.org ) and partners in the British Liver Trust (BLT) organisation. TRIAL REGISTRATION: EUDRACT reference number: 2018-002509-78. ISRCTN reference number: ISRCTN10324656. Registered on April 24 2019.

Improving personalised care and support planning for people living with treatable-but-not-curable cancer.

People living with treatable-but-not-curable (TbnC) cancer encounter cancer-related needs. While the NHS long-term plan commits to offering a Holistic Needs Assessment (HNA) and care plan to all people diagnosed with cancer, the content, delivery and timing of this intervention differs across practice. Understanding how people make sense of their cancer experience can support personalised care. A conceptual framework based on personal narratives of living with and beyond cancer (across different cancer types and all stages of the disease trajectory), identified three interlinked themes: Adversity, Restoration and Compatibility, resulting in the ARC framework.Our aim was to use the ARC framework to underpin the HNA to improve the experience of personalised care and support planning for people living with TbnC cancer. We used clinical work experience to operationalise the ARC framework and develop the intervention, called the ARC HNA, and service-level structure, called the ARC clinic. We sought expert input on the proposed content and structure from patients and clinicians through involvement and engagement activities. Delivered alongside standard care, the ARC HNA was piloted with patients on the TbnC cancer (myeloma and metastatic breast, prostate or lung) pathway, who were 6-24 months into their treatment. Iterations were made to the content, delivery and timing of the intervention based on user feedback.Fifty-one patients received the intervention. An average of 12 new concerns were identified per patient, and 96% of patients achieved at least one of their goals. Patients valued the space for reflection and follow-up, and clinicians valued the collaborative approach to meeting patients' supportive care needs. Compared with routine initial HNA and care plan completion rates of 13%, ARC clinic achieved 90% with all care plans shared with general practitioners. The ARC clinic adopts a novel and proactive approach to delivering HNAs and care plans in a meaningful and personalised way.

Factors that influence the feasibility and implementation of a complex intervention to improve the treatment of peripheral arterial disease in primary and secondary care: a qualitative exploration of patient and provider perspectives.

OBJECTIVES: Our aim was to examine the feasibility and implementation of a complex intervention to improve the care of patients with peripheral arterial disease (the LEGS intervention) from the perspective of patients, general practitioners and secondary care clinicians. DESIGN: A qualitative study involving semistructured individual interviews with patients and providers to gain an understanding of the feasibility of the LEGS intervention as well the barriers and facilitators to implementation in secondary and primary care. SETTING: Primary and secondary care settings across two National Health Service Trusts. PARTICIPANTS: Twenty-five semistructured telephone interviews were conducted with (1) patients who had received the intervention (n=11), (2) secondary care clinicians responsible for delivering the intervention (n=8) and (3) general practitioners (n=6). ANALYSIS: Data were initially analysed using inductive descriptive thematic analysis. The consolidated framework for implementation research was then used as a matrix to explore patterns in the data and to map connections between the three participant groups. Lastly, interpretive analysis allowed for refining, and a final coding frame was developed. RESULTS: Four overarching themes were identified: (1) the potential to make a difference, (2) a solution to address the gap in no man's land, (3), prioritising and making it happen and (4) personalised information and supportive conversations for taking on the advice. The impetus for prioritising and delivering the intervention was further driven by its flexibility and adaptability to be tailored to the individual and to the environment. CONCLUSIONS: The LEGS intervention can be tailored for use at early and late stages of peripheral arterial disease, provides an opportunity to meet patient needs and can be used to promote shared working across the primary-secondary care interface.

General practitioner perspectives on factors that influence implementation of secondary care-initiated treatment in primary care: Exploring implementation beyond the context of a clinical trial.

BACKGROUND: The Beta-blockers Or Placebo for Primary Prophylaxis of oesophageal varices (BOPPP) trial is a 3-year phase IV, multi-centre clinical trial of investigational medicinal product (CTIMP) that aims to determine the effectiveness of carvedilol in the prevention of variceal bleeding for small oesophageal varices in patients with cirrhosis. Early engagement of General Practitioners (GPs) in conversations about delivery of a potentially effective secondary care-initiated treatment in primary care provides insights for future implementation. The aim of this study was to understand the implementation of trial findings by exploring i) GP perspectives on factors that influence implementation beyond the context of the trial and ii) how dose titration and ongoing treatment with carvedilol is best delivered in primary care. METHODS: This qualitative study was embedded within the BOPPP trial and was conducted alongside site opening. GP participants were purposively sampled and recruited from ten Clinical Commissioning Groups in England and three Health Boards across Wales. Semi-structured telephone individual interviews were conducted with GPs (n = 23) working in England and Wales. Data were analysed using reflexive thematic analysis. FINDINGS: Five overarching themes were identified: i) primary care is best placed for oversight, ii) a shared approach led by secondary care, iii) empower the patient to take responsibility, iv) the need to go above and beyond and v) develop practice guidance. The focus on prevention, attention to holistic care, and existing and often long-standing relationships with patients provides an impetus for GP oversight. GPs spoke about the value of partnership working with secondary care and of prioritising patient-centred care and involving patients in taking responsibility for their own health. An agreed pathway of care, clear communication, and specific, accessible guidance on how to implement the proposed treatment strategy safely and effectively are important determinants in the success of implementation. CONCLUSIONS: Our findings for implementing secondary care-initiated treatment in primary care are important to the specifics of the BOPPP trial but can also go some way in informing wider learning for other trials where work is shared across the primary-secondary care interface, and where findings will impact the primary care workload. We propose a systems research perspective for addressing implementation of CTIMP findings at the outset of research. The value of early stakeholder involvement is highlighted, and the need to consider complexity in terms of the interaction between the intervention and the context in which it is implemented is acknowledged. TRIAL REGISTRATION: ISRCTN10324656.

Managing emotions in psychosis: Evaluation of a brief DBT-informed skills group for individuals with psychosis in routine community services.

OBJECTIVES: Individuals with psychosis report that emotion regulation (ER) difficulties are treatment priorities, yet little is known about how targeted ER interventions may help. We evaluated a new eight-session Dialectical Behavioural Therapy (DBT)-informed skills group specifically adapted for individuals with psychosis: the Managing Emotions Group (MEG) in diverse, inner-city community services. METHOD: A mixed-method design was utilised to assess the feasibility (acceptability and potential clinical impact) of local delivery of MEG. Uptake, completion (≥50% of sessions), post-session satisfaction ratings, and thematic analysis of qualitative feedback from 12 completers assessed acceptability. Pre-post-intervention changes in psychological distress, self-reported ER difficulties, and adaptive ER skill use assessed potential clinical impact. RESULTS: Forty-eight individuals (81% of attenders) completed the intervention (Mage = 43, 54% female) of whom 39 completed pre- and post-group measures. Participants reported high satisfaction and meaningful improvements in understanding and managing emotions, with positive impact on daily life. Self-reported psychological distress, ER difficulties, and adaptive ER skill use significantly improved, with medium-to-large pre-post effects (d = 0.5-0.7) except lack of emotional clarity (d = 0.3). CONCLUSIONS: MEG was feasible and acceptable, and a future feasibility randomised controlled trial is warranted. PRACTITIONER POINTS: Individuals with psychosis report that support with their emotions is a priority. Brief interventions for emotion regulation difficulties are acceptable to individuals with psychosis and can be feasibly delivered in a local outpatient service. Distress and emotion regulation difficulties and skills improved significantly from pre-post treatment for clients completing the managing emotions group. Further implementation and evaluation are needed to support continued refinement to meet the needs and priorities of individuals with psychosis.

Using a theory-informed approach to explore patient and staff perspectives on factors that influence clinical trial recruitment for patients with cirrhosis and small oesophageal varices.

OBJECTIVE: The success of pharmacological randomised controlled trials (RCTs) depends on the recruitment of the required number of participants. Recruitment to RCTs for patients with cirrhosis and small oesophageal varices raises specific additional challenges. The objectives of the study were 1) to explore patient perspectives on factors that influence RCT recruitment, 2) to understand factors that influence the success of recruitment from a staff perspective, and 3) to identify opportunities for tailored interventions to improve trial recruitment in this context. METHODS: The qualitative study was embedded in a multi-centre blinded RCT (BOPPP trial) and was conducted alongside site opening. Semi-structured interviews were conducted with patients who enrolled to participate in the trial (n = 13), patients who declined to take part (n = 5), and staff who were responsible for recruiting participants to the trial (n = 18). An open approach to data collection and analysis was adopted and the Theoretical Domains Framework (TDF) was used to provide a theoretical lens through which to view influences on behaviour. Data was analysed using thematic analysis. RESULTS: The findings consist of 5 overarching themes that outline trial recruitment influences at the patient, staff, team, organisational and trial levels: i) patient risks and benefits ii) staff attitudes, knowledge and capacity, iii) team-based approach, iv) organisational context and v) Trial collective. Patient-generated themes map onto thirteen of the fourteen TDF domains and staff-generated themes map onto all TDF domains. The overarching themes are not mutually exclusive; with evidence of direct interactions between patient and staff-level themes that influence recruitment behaviours. CONCLUSIONS: This study uses a theory-informed approach to gain new insights into improving clinical trial recruitment for patients with cirrhosis and small oesophageal varices. Although people with cirrhosis often display decreased healthcare-seeking behaviours, we found that patients used research to empower themselves to improve their health. Pragmatic trials involving unpredictable populations require staff expertise in building trust, and a deep knowledge of the patient group and their vulnerabilities. RCT recruitment is also more successful when research visits align with what staff identified as the natural rhythm of care. TRIAL REGISTRATION: ISRCTN10324656; https://clinicaltrials.gov/.

A Community and Hospital cAre Bundle to improve the medical treatment of severe cLaudIcation and critical limb iSchaemia (CHABLIS).

Background: Patients with peripheral artery disease (PAD) often do not receive optimal best medical therapy (BMT). Through interaction with patients and healthcare-professionals (HCPs) we developed the LEaflet Gp letter Structured checklist (LEGS) complex clinical intervention to support HCPs in providing guideline-compliant PAD BMT. Methods: This was a prospective multicentre study assessing the feasibility and fidelity of delivering the LEGS intervention in primary and secondary care over six months. Intervention fidelity was scored based on the proportion of intervention components used correctly at discharge, 30 days, and six months. Results: Overall, 129 individuals were screened and 120 took part (33% female, 74% with chronic limb threatening ischaemia; 93% recruitment rate). Of those, 118 (98% retention rate) completed follow-up. Mean intervention fidelity score at discharge (primary outcome measure) was 63% [95% Confidence Interval (CI): 39-68%, SD: 5%], exceeding the success criteria set at 60% by a panel of HCPs and patients. This, however, declined to 51% at six months. Eight patients (6.7%) died (all cardiovascular deaths), four (3.3%) had a major lower limb amputation, 12 (10%) had a cardiovascular event, and 13 (11%) were admitted due to limb ischaemia at six months. Incomplete lipid therapy prescriptions and LEGS intervention documents not received by primary care CHPs were the most common reasons for not complying with the LEGS intervention. Conclusions: The LEGS intervention can be delivered in PAD care pathways across different hospitals, primary, and community healthcare settings with acceptable fidelity, to streamline and improve PAD BMT short- and medium-term.

'Still living with it even though it's gone': Using interpretive phenomenological analysis to explore shared experiences of living with and beyond breast, prostate, and colorectal cancer.

PURPOSE: Living with and beyond cancer is an increasingly common experience. While research is uncovering valuable individual experiences of those living with and beyond cancer, it has been argued that this idiographic approach is limited in outlook, reach and impact. This study contributes to the understanding of what it means to live with and beyond cancer by complementing idiographic knowledge with multiple perspectives from a group of participants who are living with and beyond cancer, to explore how individual experiences may be relevant to others. METHOD: Semi-structured interviews were conducted with people who had received treatment for breast (n = 6), prostate (n = 6) or colorectal cancer (n = 6). Data were analysed using interpretive phenomenological analysis. The early findings were then shared with a wider group of people who had received treatment for breast, prostate or colorectal cancer (n = 26) in six focus groups, to explore whether they had similar experiences. RESULTS: While individual accounts of living with and beyond cancer detail unique features specific to each person's experience, focus group discussions illustrated how participant life worlds interact and overlap. The findings identified thematic similarities within and between individual and group levels and across cancer types. Three super-ordinate themes describe the shared experience of living with and beyond cancer: i) the cancer shock, ii) managing cancer and getting through and iii) getting over cancer. CONCLUSIONS: A multiple perspective approach informs our understanding of shared experiences of living with and beyond cancer. This knowledge can be used to direct, design, and deliver relevant supportive cancer care.

Conceptual framework for living with and beyond cancer: A systematic review and narrative synthesis.

OBJECTIVE: The concept of living with and beyond cancer is now emerging in policy and literature. Rather than viewing this notion simply as a linear timeline, developing an agreed understanding of the lived experience of people affected by cancer will aid the development of person-centred models of care. METHODS: A systematic review was conducted. The review question was "What does the term 'living with and beyond cancer' mean to people affected by cancer?" The protocol for the review was preregistered in the PROSPERO database (PROSPERO CRD42017059860). All included studies were qualitative, so narrative synthesis was used to integrate descriptions and definitions of living with and beyond cancer into an empirically based conceptual framework. RESULTS: Out of 2345 papers that were identified and 180 that were reviewed, a total of 73 papers were included. The synthesis yielded three interlinked themes: Adversity (realising cancer), Restoration (readjusting life with cancer), and Compatibility (reconciling cancer), resulting in the ARC framework. CONCLUSIONS: Three themes describe the experience of living with and beyond cancer: adversity, restoration, and compatibility. The ARC framework provides an empirically informed grounding for future research and practice in supportive cancer care for this population.

Service user experiences of REFOCUS: a process evaluation of a pro-recovery complex intervention.

PURPOSE: Policy is increasingly focused on implementing a recovery-orientation within mental health services, yet the subjective experience of individuals receiving a pro-recovery intervention is under-studied. The aim of this study was to explore the service user experience of receiving a complex, pro-recovery intervention (REFOCUS), which aimed to encourage the use of recovery-supporting tools and support recovery-promoting relationships. METHODS: Interviews (n = 24) and two focus groups (n = 13) were conducted as part of a process evaluation and included a purposive sample of service users who received the complex, pro-recovery intervention within the REFOCUS randomised controlled trial (ISRCTN02507940). Thematic analysis was used to analyse the data. RESULTS: Participants reported that the intervention supported the development of an open and collaborative relationship with staff, with new conversations around values, strengths and goals. This was experienced as hope-inspiring and empowering. However, others described how the recovery tools were used without context, meaning participants were unclear of their purpose and did not see their benefit. During the interviews, some individuals struggled to report any new tasks or conversations occurring during the intervention. CONCLUSION: Recovery-supporting tools can support the development of a recovery-promoting relationship, which can contribute to positive outcomes for individuals. The tools should be used in a collaborative and flexible manner. Information exchanged around values, strengths and goals should be used in care-planning. As some service users struggled to report their experience of the intervention, alternative evaluation approaches need to be considered if the service user experience is to be fully captured.

The relationship between clinical and recovery dimensions of outcome in mental health.

BACKGROUND: Little is known about the empirical relationship between clinical and personal recovery. AIMS: To examine whether there are separate constructs of clinical recovery and personal recovery dimensions of outcome, how they change over time and how they can be assessed. METHOD: Standardised outcome measures were administered at baseline and one-year follow-up to participants in the REFOCUS Trial (ISRCTN02507940). An exploratory factor analysis was conducted and a confirmatory factor analysis assessed change across time. RESULTS: We identified three factors: patient-rated personal recovery, patient-rated clinical recovery and staff-rated clinical recovery. Only the personal recovery factor improved after one year. HHI, CANSAS-P and HoNOS were the best measures for research and practice. CONCLUSIONS: The identification of three rather than two factors was unexpected. Our findings support the value of concurrently assessing staff and patient perceptions of outcome. Only the personal recovery factor changed over time, this desynchrony between clinical and recovery outcomes providing empirical evidence that clinical recovery and personal recovery are not the same. We did not find evidence of a trade-off between clinical recovery and personal recovery outcomes. Optimal assessment based on our data would involve assessment of hope, social disability and patient-rated unmet need.

Psychometric evaluation of the Questionnaire about the Process of Recovery (QPR).

BACKGROUND: Supporting recovery is the aim of national mental health policy in many countries. However, only one measure of recovery has been developed in England: the Questionnaire about the Process of Recovery (QPR), which measures recovery from the perspective of adult mental health service users with a psychosis diagnosis. AIMS: To independently evaluate the psychometric properties of the 15- and 22-item versions of the QPR. METHOD: Two samples were used: data-set 1 (n = 88) involved assessment of the QPR at baseline, 2 weeks and 3 months. Data-set 2 (n = 399; trial registration: ISRCTN02507940) involved assessment of the QPR at baseline and 1 year. RESULTS: For the 15-item version, internal consistency was 0.89, convergent validity was 0.73, test-retest reliability was 0.74 and sensitivity to change was 0.40. Confirmatory factor analysis showed the 15-item version offered a good fit. For the 22-item version, the interpersonal subscale was found to underperform and the intrapersonal subscale overlaps substantially with the 15-item version. CONCLUSIONS: Both the 15-item and the intrapersonal subscale of the 22-item versions of the QPR demonstrated satisfactory psychometric properties. The 15-item version is slightly more robust and also less burdensome, so it can be recommended for use in research and clinical practice.

Development of the REFOCUS intervention to increase mental health team support for personal recovery.

BACKGROUND: There is an emerging evidence base about best practice in supporting recovery. This is usually framed in relation to general principles, and specific pro-recovery interventions are lacking. AIMS: To develop a theoretically based and empirically defensible new pro-recovery manualised intervention--called the REFOCUS intervention. METHOD: Seven systematic and two narrative reviews were undertaken. Identified evidence gaps were addressed in three qualitative studies. The findings were synthesised to produce the REFOCUS intervention, manual and model. RESULTS: The REFOCUS intervention comprises two components: recovery-promoting relationships and working practices. Approaches to supporting relationships comprise coaching skills training for staff, developing a shared team understanding of recovery, exploring staff values, a Partnership Project with people who use the service and raising patient expectations. Working practices comprise the following: understanding values and treatment preferences; assessing strengths; and supporting goal-striving. The REFOCUS model describes the causal pathway from the REFOCUS intervention to improved recovery. CONCLUSIONS: The REFOCUS intervention is an empirically supported pro-recovery intervention for use in mental health services. It will be evaluated in a multisite cluster randomised controlled trial (ISRCTN02507940).

Supporting recovery in patients with psychosis through care by community-based adult mental health teams (REFOCUS): a multisite, cluster, randomised, controlled trial.

BACKGROUND: Mental health policy in many countries is oriented around recovery, but the evidence base for service-level recovery-promotion interventions is lacking. METHODS: We did a cluster, randomised, controlled trial in two National Health Service Trusts in England. REFOCUS is a 1-year team-level intervention targeting staff behaviour to increase focus on values, preferences, strengths, and goals of patients with psychosis, and staff-patient relationships, through coaching and partnership. Between April, 2011, and May, 2012, community-based adult mental health teams were randomly allocated to provide usual treatment plus REFOCUS or usual treatment alone (control). Baseline and 1-year follow-up outcomes were assessed in randomly selected patients. The primary outcome was recovery and was assessed with the Questionnaire about Processes of Recovery (QPR). We also calculated overall service costs. We used multiple imputation to estimate missing data, and the imputation model captured clustering at the team level. Analysis was by intention to treat. This trial is registered, number ISRCTN02507940. FINDINGS: 14 teams were included in the REFOCUS group and 13 in the control group. Outcomes were assessed in 403 patients (88% of the target sample) at baseline and in 297 at 1 year. Mean QPR total scores did not differ between the two groups (REFOCUS group 40·6 [SD 10·1] vs control 40·0 [10·2], adjusted difference 0·68, 95% CI -1·7 to 3·1, p=0·58). High team participation was associated with higher staff-rated scores for recovery-promotion behaviour change (adjusted difference -0·4, 95% CI -0·7 to -0·2, p=0·001) and patient-rated QPR interpersonal scores (-1·6, -2·7 to -0·5, p=0·005) at follow-up than low participation. Patients treated in the REFOCUS group incurred £1062 (95% CI -1103 to 3017) lower adjusted costs than those in the control group. INTERPRETATION: Although the primary endpoint was negative, supporting recovery might, from the staff perspective, improve functioning and reduce needs. Implementation of REFOCUS could increase staff recovery-promotion behaviours and improve patient-rated recovery. FUNDING: National Institute for Health Research.

Development and evaluation of an Individualized Outcome Measure (IOM) for randomized controlled trials in mental health.

Pre-defined, researcher-selected outcomes are routinely used as the clinical end-point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient-specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow-up. For PPO, patients choose an outcome domain related to their goal from a pre-defined list at baseline, and complete a standardized questionnaire assessing the chosen outcome domain at baseline and follow-up. A feasibility study indicated that IOM had adequate completion (89%) and acceptability (96%) rates in a clinical sample (n = 84). IOM was then evaluated in a RCT (ISRCTN02507940). GA and PPO components were associated with each other and with the trial primary outcome. The use of the PPO component of IOM as the primary outcome could be considered in future RCTs. Copyright © 2015 John Wiley & Sons, Ltd.

Staff understanding of recovery-orientated mental health practice: a systematic review and narrative synthesis.

BACKGROUND: Mental health policy is for staff to transform their practice towards a recovery orientation. Staff understanding of recovery-orientated practice will influence the implementation of this policy. The aim of this study was to conduct a systematic review and narrative synthesis of empirical studies identifying clinician and manager conceptualisations of recovery-orientated practice. METHODS: A systematic review of empirical primary research was conducted. Data sources were online databases (n = 8), journal table of contents (n = 5), internet, expert consultation (n = 13), reference lists of included studies and references to included studies. Narrative synthesis was used to integrate the findings. RESULTS: A total of 10,125 studies were screened, 245 full papers were retrieved, and 22 were included (participants, n = 1163). The following three conceptualisations of recovery-orientated practice were identified: clinical recovery, personal recovery and service-defined recovery. Service-defined recovery is a new conceptualisation which translates recovery into practice according to the goals and financial needs of the organisation. CONCLUSIONS: Organisational priorities influence staff understanding of recovery support. This influence is leading to the emergence of an additional meaning of recovery. The impact of service-led approaches to operationalising recovery-orientated practice has not been evaluated. TRIAL REGISTRATION: The protocol for the review was pre-registered (PROSPERO 2013: CRD42013005942 ).

The feasibility of implementing recovery, psychosocial and pharmacological interventions for psychosis: comparison study.

BACKGROUND: Clinical guidelines for the treatment of people experiencing psychosis have existed for over a decade, but implementation of recommended interventions is limited. Identifying influences on implementation may help to reduce this translational gap. The Structured Assessment of Feasibility (SAFE) measure is a standardised assessment of implementation blocks and enablers. The aim of this study was to characterise and compare the implementation blocks and enablers for recommended psychosis interventions. METHODS: SAFE was used to evaluate and compare three groups of interventions recommended in the 2014 NICE psychosis guideline: pharmacological (43 trials testing 5 interventions), psychosocial (65 trials testing 5 interventions), and recovery (19 trials testing 5 interventions). The 127 trial reports rated with SAFE were supplemented by published intervention manuals, research protocols, trial registrations and design papers. Differences in the number of blocks and enablers across the three interventions were tested statistically, and feasibility profiles were generated. RESULTS: There was no difference between psychosocial and recovery interventions in the number of blocks or enablers to implementation. Pharmacological interventions (a) had fewer blocks than both psychosocial interventions (χ (2)(3) = 133.77, p < 0.001) and recovery interventions (χ (2)(3) = 104.67, p < 0.001) and (b) did not differ in number of enablers from recovery interventions (χ (2)(3) = 0.74, p = 0.863) but had fewer enablers than psychosocial interventions (χ (2)(3) = 28.92, p < 0.001). Potential adverse events associated with the intervention tend to be a block for pharmacological interventions, whereas complexity of the intervention was the most consistent block for recovery and psychosocial interventions. CONCLUSIONS: Feasibility profiles show that pharmacological interventions are relatively easy to implement but can sometimes involve risks. Psychosocial and recovery interventions are relatively complex but tend to be more flexible and more often manualised. SAFE ratings can contribute to tackling the current implementation challenges in mental health services, by providing a reporting guideline structure for researchers to maximise the potential for implementation and by informing prioritisation decisions by clinical guideline developers and service managers.

Competing priorities: staff perspectives on supporting recovery.

Recovery has come to mean living a life beyond mental illness, and recovery orientation is policy in many countries. The aims of this study were to investigate what staff say they do to support recovery and to identify what they perceive as barriers and facilitators associated with providing recovery-oriented support. Data collection included ten focus groups with multidisciplinary clinicians (n = 34) and team leaders (n = 31), and individual interviews with clinicians (n = 18), team leaders (n = 6) and senior managers (n = 8). The identified core category was Competing Priorities, with staff identifying conflicting system priorities that influence how recovery-oriented practice is implemented. Three sub-categories were: Health Process Priorities, Business Priorities, and Staff Role Perception. Efforts to transform services towards a recovery orientation require a whole-systems approach.

Development and evaluation of the INSPIRE measure of staff support for personal recovery.

BACKGROUND: No individualised standardised measure of staff support for mental health recovery exists. AIMS: To develop and evaluate a measure of staff support for recovery. DEVELOPMENT: initial draft of measure based on systematic review of recovery processes; consultation (n = 61); and piloting (n = 20). Psychometric evaluation: three rounds of data collection from mental health service users (n = 92). RESULTS: INSPIRE has two sub-scales. The 20-item Support sub-scale has convergent validity (0.60) and adequate sensitivity to change. Exploratory factor analysis (variance 71.4-85.1 %, Kaiser-Meyer-Olkin 0.65-0.78) and internal consistency (range 0.82-0.85) indicate each recovery domain is adequately assessed. The 7-item Relationship sub-scale has convergent validity 0.69, test-retest reliability 0.75, internal consistency 0.89, a one-factor solution (variance 70.5 %, KMO 0.84) and adequate sensitivity to change. A 5-item Brief INSPIRE was also evaluated. CONCLUSIONS: INSPIRE and Brief INSPIRE demonstrate adequate psychometric properties, and can be recommended for research and clinical use.

Implementing a complex intervention to support personal recovery: a qualitative study nested within a cluster randomised controlled trial.

OBJECTIVE: To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams. DESIGN: Process evaluation nested within a cluster randomised controlled trial (RCT). PARTICIPANTS: 28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written trainer reports. SETTING: 14 community-based mental health teams in two UK sites (one urban, one semi-rural) who received the intervention. RESULTS: The factors influencing the implementation of the intervention can be organised under two over-arching themes: Organisational readiness for change and Training effectiveness. Organisational readiness for change comprised three sub-themes: NHS Trust readiness; Team readiness; and Practitioner readiness. Training effectiveness comprised three sub-themes: Engagement strategies; Delivery style and Modelling recovery principles. CONCLUSIONS: Three findings can inform future implementation and evaluation of complex interventions. First, the underlying intervention model predicted that three areas would be important for changing practice: staff skill development; intention to implement; and actual implementation behaviour. This study highlighted the importance of targeting the transition from practitioners' intent to implement to actual implementation behaviour, using experiential learning and target setting. Second, practitioners make inferences about organisational commitment by observing the allocation of resources, Knowledge Performance Indicators and service evaluation outcome measures. These need to be aligned with recovery values, principles and practice. Finally, we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs. We believe this would maximise the likelihood of adequate implementation and hence reduce waste in research expenditure. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN02507940.