Enhancing the quality of psychological interventions delivered by telephone in mental health services: increasing the likelihood of successful implementation using a theory of change.

BACKGROUND: The implementation of new and complex interventions in mental health settings can be challenging. This paper explores the use of a Theory of Change (ToC) for intervention design and evaluation to increase the likelihood of complex interventions being effective, sustainable, and scalable. Our intervention was developed to enhance the quality of psychological interventions delivered by telephone in primary care mental health services. METHODS: A ToC represents how our designed quality improvement intervention targeting changes at service, practitioner, and patient levels was expected to improve engagement in, and the quality of, telephone-delivered psychological therapies. The intervention was evaluated following implementation in a feasibility study within three NHS Talking Therapies services through a qualitative research design incorporating semi-structured interviews and a focus group with key stakeholders (patients, practitioners, and service leads) (N = 15). Data were analysed using the Consolidated Framework for Implementation Research (CFIR) and the ToC was examined and modified accordingly following the findings. RESULTS: CFIR analysis highlighted a set of challenges encountered during the implementation of our service quality improvement telephone intervention that appeared to have weakened the contribution to the change mechanisms set out by the initial ToC. Findings informed changes to the intervention and refinement of the ToC and are expected to increase the likelihood of successful future implementation in a randomised controlled trial. CONCLUSIONS: Four key recommendations that could help to optimise implementation of a complex intervention involving different key stakeholder groups in any setting were identified. These include: 1-developing a good understanding of the intervention and its value among those receiving the intervention; 2-maximising engagement from key stakeholders; 3-ensuring clear planning and communication of implementation goals; and 4-encouraging the use of strategies to monitor implementation progress.

Qualitative Review on Domains of Quality of Life Important for Patients, Social Care Users, and Informal Carers to Inform the Development of the EQ-HWB.

OBJECTIVES: To identify the themes to inform the content of a new generic measure, the EQ-HWB (EQ Health and Wellbeing), that can be used in economic evaluation across health, social care, and public health, based on the views of users and beneficiaries of these services including informal carers. METHODS: A qualitative review was undertaken. Systematic and citation searches were undertaken focusing on qualitative evidence of the impact on quality of life from reviews for selected health conditions, informal carers, social care users, and primary qualitative work used in the development of selected measures. A subset of studies was included in the review. Framework analysis and synthesis were undertaken based on a conceptual model. RESULTS: A total of 42 reviews and 24 primary studies were selected for inclusion in the review. Extraction and synthesis resulted in 7 high-level themes (with subthemes): (1) feelings and emotions (sadness, anxiety, hope, frustration, safety, guilt/shame); (2) cognition (concentration, memory, confusion, thinking clearly); (3) self-identity (dignity/respect, self-esteem); (4) "coping, autonomy, and control" relationships; (5) social connections (loneliness, social engagement, stigma, support, friendship, belonging, burden); (6) physical sensations (pain, discomfort, sleep, fatigue); and (7) activity (self-care, meaningful activities, mobility, communication, hearing, vision). Apart from physical sensations, most of the other themes and subthemes were relevant across both health and social care, including for informal carers. CONCLUSIONS: The findings from this broad review identified themes that go beyond health and that are relevant to patients, informal carers, and social care users. The themes and subthemes informed the domains for the EQ-HWB.

Generation, Selection, and Face Validation of Items for a New Generic Measure of Quality of Life: The EQ-HWB.

OBJECTIVES: This article aims to describe the generation and selection of items (stage 2) and face validation (stage 3) of a large international (multilingual) project to develop a new generic measure, the EQ-HWB (EQ Health and Wellbeing), for use in economic evaluation across health, social care, and public health to estimate quality-adjusted life-years. METHODS: Items from commonly used generic, carer, social care, and mental health quality of life measures were mapped onto domains or subdomains identified from a literature review. Potential terms and items were reviewed and refined to ensure coverage of the construct of the domains/subdomain (stage 2). Input on the potential item pool, response options, and recall period was sought from 3 key stakeholder groups. The pool of candidate items was tested in qualitative interviews with potential future users in an international face validation study (stage 3). RESULTS: Stage 2 resulted in the generation of 687 items. Predetermined selection criteria were applied by the research team resulting in 598 items being dropped, leaving 89 items that were reviewed by key stakeholder groups. Face validation (stage 3) tested 97 draft items and 4 response scales. A total of 47 items were retained and 14 were modified, whereas 3 were added to the candidate pool of items. This resulted in a 64-item set. CONCLUSIONS: This international multiculture, multilingual study with a common methodology identified many items that performed well across all countries. These were taken to the psychometric testing along with modified and new items for the EQ-HWB.

The EQ-HWB: Overview of the Development of a Measure of Health and Wellbeing and Key Results.

OBJECTIVES: Existing measures for estimating quality-adjusted life-years are mostly limited to health-related quality of life. This article presents an overview of the development the EQ-HWB (EQ Health and Wellbeing), which is a measure that encompasses health and wellbeing. METHODS: Stages: (1) Establishing domains through reviews of the qualitative literature informed by a conceptual framework. (2) Generation and selection of items to cover the domains. (3) Face validation of these items through qualitative interviews with 168 patients, social care users, general population, and carers across 6 countries (Argentina, Australia, China, Germany, United Kingdom, United States). (4) Extensive psychometric testing of candidate items (using classical, factor analysis, and item response theory methods) on > 4000 respondents in the 6 countries. Stakeholders were consulted throughout. RESULTS: A total of 32 subdomains grouped into 7 high-level domains were identified from the qualitative literature and 97 items generated to cover them. Face validation eliminated 36 items, modified 14, and added 3. Psychometric testing of 64 items found little difference in missing data or problems with response distribution, the conceptual model was confirmed except in China, and most items performed well in the item response theory in all countries. Evidence was presented to stakeholders in 2 rounds of consultation to inform the final selection of items for the EQ-HWB (25-item) and the short version of EQ-HWB (9-items). CONCLUSIONS: EQ-HWB measures have been developed internationally for evaluating interventions in health, public health, and social care including the impact on patients, social care users, and carers.

Integrating mental health care into home-based nursing services: A qualitative study utilising normalisation process theory.

AIMS AND OBJECTIVES: To identify barriers and facilitators to implementing community nurses being trained as psychological wellbeing practitioners and integrating this practice into home-based primary care nursing, through key stakeholders' perceptions. BACKGROUND: Current drivers in UK primary care aim to increase access to mental health services and treatment, to achieve parity of esteem between physical and mental health care for patients who are housebound. However, there remains limited evidence on how to successfully implement this. Training community nurses as psychological wellbeing practitioners to offer mental health care alongside their current home-based services is one option. DESIGN: A pluralistic qualitative study. This study followed the COREQ checklist for reporting qualitative research. METHODS: Twenty key stakeholders were purposively recruited and interviewed including twelve health professionals and eight patients. Semi-structured interviews were analysed using a theoretical thematic analysis informed by normalisation process theory concepts of coherence, cognitive participation, collective action and reflexive monitoring, to explore the barriers and facilitators to implementation. RESULTS: Staff and patients reported high coherence and cognitive participation, valuing the integrated roles. Facilitators included the development of clearer referral pathways and increased mental health knowledge in the wider team. However, sustainability and current siloed healthcare systems were identified as barriers to implementation. CONCLUSIONS: A key obstacle to long-term implementation was the practical structures and financial boundaries of siloed healthcare systems, making long-term sustainability unviable. RELEVANCE TO CLINICAL PRACTICE: Community nurses with additional mental health training can integrate these skills in practice and are valued by their team and patients offering holistic care to patients within their home and informal knowledge transfer to the wider team. However, long-term sustainability is required if this is to be adopted routinely. Further evidence is needed to better understand the positive outcomes to patients and potential cost savings.

Criteria for item selection for a preference-based measure for use in economic evaluation.

Preference-based measures allow patients to report their level of health, and the responses are then scored using preference weights from a representative general population sample for use in cost utility analysis. The development process of new preference-based measures should ensure that valid items are selected to reflect the constructs of interest included in the measure and that are suitable for use in preference-elicitation exercises. Existing criteria on patient-reported outcome measures (PROMs) development were reviewed, and additional considerations were taken into account in order to generate criteria to support development of new preference-based measures. Criteria covering 22 different aspects related to item selection for preference-based measures are presented. These include criteria related to how items are phrased to ensure accurate completion, the coverage of items in terms of range of domains as well as focus on current outcomes and whether items are suitable for valuation. The criteria are aimed at supporting the development of new preference-based measures with discussion to ensure that even where there is conflict between criteria, issues have been considered at the item selection stage. This would minimize problems at valuation stage by harmonizing established criteria and expanding lists to reflect the unique characteristics of preference-based measures.

Social prescribing for people with complex needs: a realist evaluation.

BACKGROUND: Social Prescribing is increasingly popular, and several evaluations have shown positive results. However, Social Prescribing is an umbrella term that covers many different interventions. We aimed to test, develop and refine a programme theory explaining the underlying mechanisms operating in Social Prescribing to better enhance its effectiveness by allowing it to be targeted to those who will benefit most, when they will benefit most. METHODS: We conducted a realist evaluation of a large Social Prescribing organisation in the North of England. Thirty-five interviews were conducted with stakeholders (clients attending Social Prescribing, Social Prescribing staff and general practice staff). Through an iterative process of analysis, a series of context-mechanism-outcome configurations were developed, refined and retested at a workshop of 15 stakeholders. The initial programme theory was refined, retested and 'applied' to wider theory. RESULTS: Social Prescribing in this organisation was found to be only superficially similar to collaborative care. A complex web of contexts, mechanisms and outcomes for its clients are described. Key elements influencing outcomes described by stakeholders included social isolation and wider determinants of health; poor interagency communication for people with multiple needs. Successful Social Prescribing requires a non-stigmatising environment and person-centred care, and shares many features described by the asset-based theory of Salutogenesis. CONCLUSIONS: The Social Prescribing model studied is holistic and person-centred and as such enables those with a weak sense of coherence to strengthen this, access resistance resources, and move in a health promoting or salutogenic direction.

'So just to go through the options ': patient choice in the telephone delivery of the NHS Improving Access to Psychological Therapies services.

This article considers patient choice in mental healthcare services, specifically the ways that choice is enabled or constrained in patient-practitioner spoken interaction. Using the method of conversation analysis (CA), we examine the language used by practitioners when presenting treatment delivery options to patients entering the NHS Improving Access to Psychological Therapies (IAPT) service. Analysis of 66 recordings of telephone-delivered IAPT assessment sessions revealed three patterns through which choice of treatment delivery mode was presented to patients: presenting a single delivery mode; incrementally presenting alternative delivery modes, in response to patient resistance; and parallel presentation of multiple delivery mode options. We show that a distinction should be made between (i) a choice to accept or reject the offer of a single option and (ii) a choice that is a selection from a range of options. We show that the three patterns identified are ordered in terms of patient-centredness and shared decision-making. Our findings contribute to sociological work on healthcare interactions that has identified variability in, and variable consequences for, the ways that patients and practitioners negotiate choice and shared decision-making. Findings are discussed in relation to tensions between the political ideology of patient choice and practical service delivery constraints.

What influences practitioners' readiness to deliver psychological interventions by telephone? A qualitative study of behaviour change using the Theoretical Domains Framework.

BACKGROUND: Contemporary health policy is shifting towards remotely delivered care. A growing need to provide effective and accessible services, with maximal population reach has stimulated demand for flexible and efficient service models. The implementation of evidence-based practice has been slow, leaving many services ill equipped to respond to requests for non-face-to-face delivery. To address this translation gap, and provide empirically derived evidence to support large-scale practice change, our study aimed to explore practitioners' perspectives of the factors that enhance the delivery of a NICE-recommended psychological intervention, i.e. guided self-help by telephone (GSH-T), in routine care. We used the Theoretical Domains Framework (TDF) to analyse our data, identify essential behaviour change processes and encourage the successful implementation of remote working in clinical practice. METHOD: Thirty-four psychological wellbeing practitioners (PWPs) from the UK NHS Improving Access to Psychological Therapies (IAPT) services were interviewed. Data were first analysed inductively, with codes cross-matched deductively to the TDF. RESULTS: Analysis identified barriers to the delivery, engagement and implementation of GSH-T, within eight domains from the TDF: (i) Deficits in practitioner knowledge, (ii) Sub-optimal practitioner telephone skills, (iii) Practitioners' lack of beliefs in telephone capabilities and self-confidence, (iv) Practitioners' negative beliefs about consequences, (v) Negative emotions, (vi) Professional role expectations (vii) Negative social influences, and (viii) Challenges in the environmental context and resources. A degree of interdependence was observed between the TDF domains, such that improvements in one domain were often reported to confer secondary advantages in another. CONCLUSIONS: Multiple TDF domains emerge as relevant to improve delivery of GSH-T; and these domains are theoretically and practically interlinked. A multicomponent approach is recommended to facilitate the shift from in-person to telephone-based service delivery models, and prompt behaviour change at practitioner, patient and service levels. At a minimum, the development of practitioners' telephone skills, an increase in clients' awareness of telephone-based treatment, dilution of negative preconceptions about telephone treatment, and robust service level guidance and standards for implementation are required. This is the first study that provides clear direction on how to improve telephone delivery and optimise implementation, aligning with current mental health policy and service improvement.

'Clinically unnecessary' use of emergency and urgent care: A realist review of patients' decision making.

BACKGROUND: Demand is labelled 'clinically unnecessary' when patients do not need the levels of clinical care or urgency provided by the service they contact. OBJECTIVE: To identify programme theories which seek to explain why patients make use of emergency and urgent care that is subsequently judged as clinically unnecessary. DESIGN: Realist review. METHODS: Papers from four recent systematic reviews of demand for emergency and urgent care, and an updated search to January 2017. Programme theories developed using Context-Mechanism-Outcome chains identified from 32 qualitative studies and tested by exploring their relationship with existing health behaviour theories and 29 quantitative studies. RESULTS: Six mechanisms, based on ten interrelated programme theories, explained why patients made clinically unnecessary use of emergency and urgent care: (a) need for risk minimization, for example heightened anxiety due to previous experiences of traumatic events; (b) need for speed, for example caused by need to function normally to attend to responsibilities; (c) need for low treatment-seeking burden, caused by inability to cope due to complex or stressful lives; (d) compliance, because family or health services had advised such action; (e) consumer satisfaction, because emergency departments were perceived to offer the desired tests and expertise when contrasted with primary care; and (f) frustration, where patients had attempted and failed to obtain a general practitioner appointment in the desired timeframe. Multiple mechanisms could operate for an individual. CONCLUSIONS: Rather than only focusing on individuals' behaviour, interventions could include changes to health service configuration and accessibility, and societal changes to increase coping ability.

Public involvement in health outcomes research: lessons learnt from the development of the recovering quality of life (ReQoL) measures.

BACKGROUND: To provide a model for Public involvement (PI) in instrument development and other research based on lessons learnt in the co-production of a recently developed mental health patient reported outcome measure called Recovering Quality of Life (ReQoL). While service users contributed to the project as research participants, this paper focuses on the role of expert service users as research partners, hence referred to as expert service users or PI. METHODS: At every stage of the development, service users influenced the design, content and face validity of the measure, collaborating with other researchers, clinicians and stakeholders who were central to this research. Expert service users were integral to the Scientific Group which was the main decision-making body, and also provided advice through the Expert Service User Group. RESULTS: During the theme and item generation phase (stage 1) expert service users affirmed the appropriateness of the seven domains of the Patient Reported Outcome Measure (activity, hope, belonging and relationships, self-perception, wellbeing, autonomy, and physical health). Expert service users added an extra 58 items to the pool of 180 items and commented on the results from the face and content validity testing (stage 2) of a refined pool of 88. In the item reduction and scale generation phase (stage 3), expert service users contributed to discussions concerning the ordering and clustering of the themes and items and finalised the measures. Expert service users were also involved in the implementation and dissemination of ReQoL (stage 4). Expert service users contributed to the interpretation of findings, provided inputs at every stage of the project and were key decision-makers. The challenges include additional work to make the technical materials accessible, extra time to the project timescales, including time to achieve consensus from different opinions, sometimes strongly held, and extra costs. CONCLUSION: This study demonstrates a successful example of how PI can be embedded in research, namely in instrument development. The rewards of doing so cannot be emphasised enough but there are challenges, albeit surmountable ones. Researchers should anticipate and address those challenges during the planning stage of the project.

Risk factors for negative experiences during psychotherapy.

BACKGROUND: It is estimated that between 3% and 15% of patients have a negative experience of psychotherapy, but little is understood about this. AIMS: The aim of this study was to investigate the factors associated with patients' negative therapy experiences. METHOD: The data comprised 185 patient and 304 therapist questionnaires, 20 patient and 20 therapist interviews. Patients reported on an unhelpful or harmful experience of therapy, and therapists on a therapy where they thought the patient they were working with had a poor or harmful experience. These were transcribed and analysed using thematic analysis. RESULTS: There was a Lack of fit between Patient needs, Therapist skills, and Service structures. This could result in Fault Lines, a tension between Safety and containment and Power and control. This tension led to Strain and Poor Engagement, which led to Consequences following the negative therapy experience. CONCLUSIONS: Patients require clear information, choice, involvement in decision-making, explicit contracting and clarity about sessions and progress. Opportunities for patient feedback should be the norm, where the therapist and service are vigilant for signs of deterioration and solutions considered. Clinical and methodological significance of this article: Estimates of "unwanted effects," including long-lasting effects, of psychotherapy have ranged from 3% to 15%. Few empirical studies have been conducted in this area. This study aimed to address this gap and provide clinicians with a model of risk factors for negative therapy effects. The findings of this study indicate the importance of providing patients with a supportive service structure that offers clear information, choice and involvement in decision-making. Explicit contracting at the beginning of therapy and clarity about sessions and progress are also important in managing patient expectations throughout. Opportunities for patient feedback should be provided.

Recovering Quality of Life (ReQoL): a new generic self-reported outcome measure for use with people experiencing mental health difficulties.

BACKGROUND: Outcome measures for mental health services need to adopt a service-user recovery focus. Aims To develop and validate a 10- and 20-item self-report recovery-focused quality of life outcome measure named Recovering Quality of Life (ReQoL). METHOD: Qualitative methods for item development and initial testing, and quantitative methods for item reduction and scale construction were used. Data from >6500 service users were factor analysed and item response theory models employed to inform item selection. The measures were tested for reliability, validity and responsiveness. RESULTS: ReQoL-10 and ReQoL-20 contain positively and negatively worded items covering seven themes: activity, hope, belonging and relationships, self-perception, well-being, autonomy, and physical health. Both versions achieved acceptable internal consistency, test-retest reliability (>0.85), known-group differences, convergence with related measures, and were responsive over time (standardised response mean (SRM) > 0.4). They performed marginally better than the Short Warwick-Edinburgh Mental Well-being Scale and markedly better than the EQ-5D. CONCLUSIONS: Both versions are appropriate for measuring service-user recovery-focused quality of life outcomes. Declaration of interest M.B. and J.Co. were members of the research group that developed the Clinical Outcomes in Routine Evaluation (CORE) outcome measures.

The importance of content and face validity in instrument development: lessons learnt from service users when developing the Recovering Quality of Life measure (ReQoL).

PURPOSE: Service user involvement in instrument development is increasingly recognised as important, but is often not done and seldom reported. This has adverse implications for the content validity of a measure. The aim of this paper is to identify the types of items that service users felt were important to be included or excluded from a new Recovering Quality of Life measure for people with mental health difficulties. METHODS: Potential items were presented to service users in face-to-face structured individual interviews and focus groups. The items were primarily taken or adapted from current measures and covered themes identified from earlier qualitative work as being important to quality of life. Content and thematic analysis was undertaken to identify the types of items which were either important or unacceptable to service users. RESULTS: We identified five key themes of the types of items that service users found acceptable or unacceptable; the items should be relevant and meaningful, unambiguous, easy to answer particularly when distressed, do not cause further upset, and be non-judgemental. Importantly, this was from the perspective of the service user. CONCLUSIONS: This research has underlined the importance of service users' views on the acceptability and validity of items for use in developing a new measure. Whether or not service users favoured an item was associated with their ability or intention to respond accurately and honestly to the item which will impact on the validity and sensitivity of the measure.

Low-intensity cognitive-behaviour therapy interventions for obsessive-compulsive disorder compared to waiting list for therapist-led cognitive-behaviour therapy: 3-arm randomised controlled trial of clinical effectiveness.

BACKGROUND: Obsessive-compulsive disorder (OCD) is prevalent and without adequate treatment usually follows a chronic course. "High-intensity" cognitive-behaviour therapy (CBT) from a specialist therapist is current "best practice." However, access is difficult because of limited numbers of therapists and because of the disabling effects of OCD symptoms. There is a potential role for "low-intensity" interventions as part of a stepped care model. Low-intensity interventions (written or web-based materials with limited therapist support) can be provided remotely, which has the potential to increase access. However, current evidence concerning low-intensity interventions is insufficient. We aimed to determine the clinical effectiveness of 2 forms of low-intensity CBT prior to high-intensity CBT, in adults meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for OCD. METHODS AND FINDINGS: This study was approved by the National Research Ethics Service Committee North West-Lancaster (reference number 11/NW/0276). All participants provided informed consent to take part in the trial. We conducted a 3-arm, multicentre randomised controlled trial in primary- and secondary-care United Kingdom mental health services. All patients were on a waiting list for therapist-led CBT (treatment as usual). Four hundred and seventy-three eligible patients were recruited and randomised. Patients had a median age of 33 years, and 60% were female. The majority were experiencing severe OCD. Patients received 1 of 2 low-intensity interventions: computerised CBT (cCBT; web-based CBT materials and limited telephone support) through "OCFighter" or guided self-help (written CBT materials with limited telephone or face-to-face support). Primary comparisons concerned OCD symptoms, measured using the Yale-Brown Obsessive Compulsive Scale-Observer-Rated (Y-BOCS-OR) at 3, 6, and 12 months. Secondary outcomes included health-related quality of life, depression, anxiety, and functioning. At 3 months, guided self-help demonstrated modest benefits over the waiting list in reducing OCD symptoms (adjusted mean difference = -1.91, 95% CI -3.27 to -0.55). These effects did not reach a prespecified level of "clinically significant benefit." cCBT did not demonstrate significant benefit (adjusted mean difference = -0.71, 95% CI -2.12 to 0.70). At 12 months, neither guided self-help nor cCBT led to differences in OCD symptoms. Early access to low-intensity interventions led to significant reductions in uptake of high-intensity CBT over 12 months; 86% of the patients allocated to the waiting list for high-intensity CBT started treatment by the end of the trial, compared to 62% in supported cCBT and 57% in guided self-help. These reductions did not compromise longer-term patient outcomes. Data suggested small differences in satisfaction at 3 months, with patients more satisfied with guided self-help than supported cCBT. A significant issue in the interpretation of the results concerns the level of access to high-intensity CBT before the primary outcome assessment. CONCLUSIONS: We have demonstrated that providing low-intensity interventions does not lead to clinically significant benefits but may reduce uptake of therapist-led CBT. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) Registry ISRCTN73535163.

Thromboprophylaxis in atrial fibrillation and association with cognitive decline: systematic review.

OBJECTIVE: atrial fibrillation (AF) is associated with dementia. If AF-related cognitive decline is driven by cerebral embolic events, thromboprophylaxis may impact on this. This systematic review assessed the association between cognitive impairment and AF thromboprophylaxis. METHODS: two independent reviewers searched CINAHL, EMBASE, MEDLINE, PsycINFO, Web of Science Core Collection and Cochrane Library from inception until 12 November 2014. Eligible studies compared AF thromboprophylaxis to control with an outcome measure of cognition or dementia. Where data allowed, meta-analyses describing between-group differences in cognitive test scores or rates of incident dementia were performed. RESULTS: nineteen studies were eligible. For two prospective studies (one randomised controlled trial, RCT) comparing anticoagulation against antiplatelet therapy, change in Mini-Mental Score Examination (MMSE) score from baseline to last follow-up (maximal duration: 5.9 years) suggested a difference favouring anticoagulation (mean difference: 0.90, 95% CI: 0.29-1.51), in keeping with a trend seen in the single RCT (mean difference MMSE: 0.80, 95% CI: -0.07 to 1.67). Pooled odds ratio (OR) suggested no association with incident dementia, comparing anticoagulant to antiplatelet therapy (two studies, OR: 1.23, 95% CI: 0.80-1.91) or no treatment (three studies, OR: 0.89, 95% CI: 0.47-1.69). CONCLUSION: our analyses show no definitive evidence of cognitive benefit or harm from anticoagulation. We demonstrated a potential benefit of anticoagulation in comparison to antiplatelet over time. Larger scale studies with longer follow-up are needed to determine the true cognitive impact of AF thromboprophylaxis.

Cost-effectiveness of an improving access to psychological therapies service.

BACKGROUND: Effective psychological therapies have been recommended for common mental health problems, such as depression and anxiety, but provision has been poor. Improving Access to Psychological Therapies (IAPT) may provide a cost-effective solution to this problem. AIMS: To determine the cost-effectiveness of IAPT at the Doncaster demonstration site (2007-2009). METHOD: An economic evaluation comparing costs and health outcomes for patients at the IAPT demonstration site with those for comparator sites, including a separate assessment of lost productivity. Sensitivity analyses were undertaken. RESULTS: The IAPT site had higher service costs and was associated with small additional gains in quality-adjusted life-years (QALYs) compared with its comparator sites, resulting in a cost per QALY gained of £29 500 using the Short Form (SF-6D). Sensitivity analysis using predicted EQ-5D scores lowered this to £16 857. Costs per reliable and clinically significant (RCS) improvement were £9440 per participant. CONCLUSIONS: Improving Access to Psychological Therapies provided a service that was probably cost-effective within the usual National Institute for Health and Clinical Excellence (NICE) threshold range of £20 000-30 000, but there was considerable uncertainty surrounding the costs and outcome differences.

Quality of life of people with mental health problems: a synthesis of qualitative research.

PURPOSE: To identify the domains of quality of life important to people with mental health problems. METHOD: A systematic review of qualitative research undertaken with people with mental health problems using a framework synthesis. RESULTS: We identified six domains: well-being and ill-being; control, autonomy and choice; self-perception; belonging; activity; and hope and hopelessness. Firstly, symptoms or 'ill-being' were an intrinsic aspect of quality of life for people with severe mental health problems. Additionally, a good quality of life was characterised by the feeling of being in control (particularly of distressing symptoms), autonomy and choice; a positive self-image; a sense of belonging; engagement in meaningful and enjoyable activities; and feelings of hope and optimism. Conversely, a poor quality life, often experienced by those with severe mental health difficulties, was characterized by feelings of distress; lack of control, choice and autonomy; low self-esteem and confidence; a sense of not being part of society; diminished activity; and a sense of hopelessness and demoralization. CONCLUSIONS: Generic measures fail to address the complexity of quality of life measurement and the broad range of domains important to people with mental health problems.

What is the best approach to adopt for identifying the domains for a new measure of health, social care and carer-related quality of life to measure quality-adjusted life years? Application to the development of the EQ-HWB?

Economic evaluation combines costs and benefits to support decision-making when assessing new interventions using preference-based measures to measure and value benefits in health or health-related quality of life. These health-focused instruments have limited ability to capture wider impacts on informal carers or outcomes in other sectors such as social care. Sector-specific instruments can be used but this is problematic when the impact of an intervention straddles different sectors.An alternative approach is to develop a generic preference-based measure that is sufficiently broad to capture important cross-sector outcomes. We consider the options for the selection of domains for a cross-sector generic measure including how to identify domains, who should provide information on the domains and how this should be framed. Beyond domain identification, considerations of criteria and stakeholder needs are also identified.This paper sets out the case for an approach that relies on the voice of patients, social care users and informal carers as the main source of domains and describes how the approach was operationalised in the 'Extending the QALY' project which developed the new measure, the EQ-HWB (EQ health and wellbeing instrument). We conclude by discussing the strengths and limitations of this approach. The new measure should be sufficiently generic to be used to consistently evaluate health and social care interventions, yet also sensitive enough to pick up important changes in quality of life in patients, social care users and carers.

Person-centred experiential therapy versus cognitive behavioural therapy delivered in the English Improving Access to Psychological Therapies service for the treatment of moderate or severe depression (PRaCTICED): a pragmatic, randomised, non-inferiority trial.

BACKGROUND: The UK Government's implementation in 2008 of the Improving Access to Psychological Therapies (IAPT) initiative in England has hugely increased the availability of cognitive behavioural therapy (CBT) for the treatment of depression and anxiety in primary care. Counselling for depression-a form of person-centred experiential therapy (PCET)-has since been included as an IAPT-approved therapy, but there is no evidence of its efficacy from randomised controlled trials (RCTs), as required for recommendations by the National Institute for Health and Care Excellence. Therefore, we aimed to examine whether PCET is cost effective and non-inferior to CBT in the treatment of moderate and severe depression within the IAPT service. METHODS: This pragmatic, randomised, non-inferiority trial was done in the Sheffield IAPT service in England and recruited participants aged 18 years or older with moderate or severe depression on the Clinical Interview Schedule-Revised. We excluded participants presenting with an organic condition, a previous diagnosis of personality disorder, bipolar disorder, or schizophrenia, drug or alcohol dependency, an elevated clinical risk of suicide, or a long-term physical condition. Eligible participants were randomly assigned (1:1), independently of the research team, and stratified by site with permuted block sizes of two, four, or six, to receive either PCET or CBT by use of a remote, web-based system that revealed therapy after patient details were entered. Those assessing outcomes were masked to treatment allocation. Participants were seen by appropriately trained PCET counsellors and CBT therapists in accordance with the IAPT service delivery model. Depression severity and symptomatology measured by the Patient Health Questionnaire-9 (PHQ-9) at 6 months post-randomisation was the primary outcome, with the PHQ-9 score at 12 months post-randomisation being a key secondary outcome. These outcomes were analysed in the modified intention-to-treat population, which comprised all randomly assigned patients with complete data, and the per-protocol population, which comprised all participants who did not switch from their randomised treatment and received between four and 20 sessions. Safety was analysed in all randomly assigned patients. The non-inferiority margin was set a priori at 2 PHQ-9 points. Patient safety was monitored throughout the course of therapy, adhering to service risk procedures for monitoring serious adverse events. This trial is registered at the ISRCTN Registry, ISRCTN06461651, and is complete. FINDINGS: From Nov 11, 2014, to Aug 3, 2018, 9898 patients were referred to step three treatments in the Sheffield IAPT service for common mental health problems, of whom 761 (7·7%) were referred to the trial. Of these, we recruited and randomly assigned 510 participants to receive either PCET (n=254) or CBT (n=256). In the PCET group, 138 (54%) participants were female and 116 (46%) were male, and 225 (89%) were White, 16 (6%) were non-White, and 13 (5%) had missing ethnicity data. In the CBT group, 155 (61%) participants were female and 101 (39%) were male, and 226 (88%) were White, 17 (7%) were non-White, and 13 (5%) had missing ethnicity data. The 6-month modified intention-to-treat analysis comprised 401 (79%) of the enrolled participants (201 in the PCET group; 200 in the CBT group) and the 12-month modified intention-to-treat analysis comprised 319 participants (167 in the PCET group; 152 in the CBT group). The 6-month per-protocol analysis comprised 298 participants (154 in the PCET group; 144 in the CBT group). At 6 months post-randomisation, PCET was non-inferior to CBT in the intention-to-treat population (mean PHQ-9 score 12·74 [SD 6·54] in the PCET group and 13·25 [6·35] in the CBT group; adjusted mean difference -0·35 [95% CI -1·53 to 0·84]) and in the per-protocol population (12·73 [SD 6·57] in the PCET group and 12·71 [6·33] in the CBT group; 0·27 [95% CI -1·08 to 1·62]). At 12 months post-randomisation, there was a significant adjusted between-group difference in mean PHQ-9 score in favour of CBT (1·73 [95% CI 0·26-3·19]), with a 95% CI exceeding the 2-point non-inferiority margin. There were two deaths, one death by suicide in the PCET group and one due to chronic obstructive pulmonary disease in the CBT group. Both were assessed by the responsible clinician to be unrelated to the trial. In terms of using emergency departments for depression-related events, four people (three in the PCET group; one in the CBT group) made more than a single use and six people (three in the PCET group; three in the CBT group) made a single use. One patient in the PCET group had inpatient treatment for a depression-related event. INTERPRETATION: This trial is the first to examine the two most frequently administered psychological therapies in the IAPT service. The finding of non-inferiority of PCET to CBT at 6 months supports the results from large, routine, non-randomised datasets from the IAPT programme. Given the high demand for psychological therapies and the need for patient choice, our findings suggest the need for continued investment in the training and delivery of PCET for improving short-term outcomes, but suggest that PCET might be inferior to CBT at 12 months. FUNDING: British Association for Counselling and Psychotherapy Research Foundation.