Practitioners' ability to remotely develop understanding for personalised care and support planning: a thematic analysis of multiple data sources from the feasibility phase of the Dementia Personalised Care Team (D-PACT) intervention.

Practitioner understanding of patients' preferences, wishes and needs is essential for personalised health care i.e., focusing on 'what matters' to people based on their individual life situation. To develop such an understanding, dementia practitioners need to use communication practices that help people share their experiences, preferences, and priorities. Following the COVID-19 pandemic, dementia support is likely to continue to be delivered both remotely and in-person. This study analysed multiple sources of qualitative data to examine the views of practitioners, people living with dementia and carers, and researchers on how an understanding of what matters to people living with dementia can be developed remotely via telephone and video call. Access to environmental stimuli, the remote use of visual tools, peoples' tendency to downplay or omit details about their troubles and carers' ability to disclose privately were interpreted, through thematic analysis, to be factors affecting how practitioners sought to develop understanding remotely. Cumulatively, findings show that while remote support created unique challenges to practitioners' ability to develop understanding for personalised care, practitioners developed adaptive strategies to overcome some of these challenges. Further research should examine how, when and for whom these adapted practices for remote personalised care work, informing the development of evidence-based guidance and training on how practitioners can remotely develop the understanding required for personalised care.

Longitudinal realist evaluation of the Dementia PersonAlised Care Team (D-PACT) intervention: protocol.

BACKGROUND: Different dementia support roles exist but evidence is lacking on which aspects are best, for whom, and in what circumstances, and on their associated costs and benefits. Phase 1 of the Dementia PersonAlised Care Team programme (D-PACT) developed a post-diagnostic primary care-based intervention for people with dementia and their carers and assessed the feasibility of a trial. AIM: Phase 2 of the programme aims to 1) refine the programme theory on how, when, and for whom the intervention works; and 2) evaluate its value and impact. DESIGN & SETTING: A realist longitudinal mixed-methods evaluation will be conducted in urban, rural, and coastal areas across South West and North West England where low-income or ethnic minority populations (for example, South Asian) are represented. Design was informed by patient, public, and professional stakeholder input and phase 1 findings. METHOD: High-volume qualitative and quantitative data will be collected longitudinally from people with dementia, carers, and practitioners. Analyses will comprise the following: 1) realist longitudinal case studies; 2) conversation analysis of recorded interactions; 3) statistical analyses of outcome and experience questionnaires; 4a) health economic analysis examining costs of delivery; and 4b) realist economic analysis of high-cost events and 'near misses'. All findings will be synthesised using a joint display table, evidence appraisal tool, triangulation, and stakeholder co-analysis. CONCLUSION: The realist evaluation will describe how, why, and for whom the intervention does or does not lead to change over time. It will also demonstrate how a non-randomised design can be more appropriate for complex interventions with similar questions or populations.

Evaluation of a complex intervention for prisoners with common mental health problems, near to and after release: the Engager randomised controlled trial.

BACKGROUND: Many male prisoners have significant mental health problems, including anxiety and depression. High proportions struggle with homelessness and substance misuse. AIMS: This study aims to evaluate whether the Engager intervention improves mental health outcomes following release. METHOD: The design is a parallel randomised superiority trial that was conducted in the North West and South West of England (ISRCTN11707331). Men serving a prison sentence of 2 years or less were individually allocated 1:1 to either the intervention (Engager plus usual care) or usual care alone. Engager included psychological and practical support in prison, on release and for 3-5 months in the community. The primary outcome was the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), 6 months after release. Primary analysis compared groups based on intention-to-treat (ITT). RESULTS: In total, 280 men were randomised out of the 396 who were potentially eligible and agreed to participate; 105 did not meet the mental health inclusion criteria. There was no mean difference in the ITT complete case analysis between groups (92 in each arm) for change in the CORE-OM score (1.1, 95% CI -1.1 to 3.2, P = 0.325) or secondary analyses. There were no consistent clinically significant between-group differences for secondary outcomes. Full delivery was not achieved, with 77% (108/140) receiving community-based contact. CONCLUSIONS: Engager is the first trial of a collaborative care intervention adapted for prison leavers. The intervention was not shown to be effective using standard outcome measures. Further testing of different support strategies for prison with mental health problems is needed.

Interrogating intervention delivery and participants' emotional states to improve engagement and implementation: A realist informed multiple case study evaluation of Engager.

BACKGROUND: 'Engager' is an innovative 'through-the-gate' complex care intervention for male prison-leavers with common mental health problems. In parallel to the randomised-controlled trial of Engager (Trial registration number: ISRCTN11707331), a set of process evaluation analyses were undertaken. This paper reports on the depth multiple case study analysis part of the process evaluation, exploring how a sub-sample of prison-leavers engaged and responded to the intervention offer of one-to-one support during their re-integration into the community. METHODS: To understand intervention delivery and what response it elicited in individuals, we used a realist-informed qualitative multiple 'case' studies approach. We scrutinised how intervention component delivery lead to outcomes by examining underlying causal pathways or 'mechanisms' that promoted or hindered progress towards personal outcomes. 'Cases' (n = 24) were prison-leavers from the intervention arm of the trial. We collected practitioner activity logs and conducted semi-structured interviews with prison-leavers and Engager/other service practitioners. We mapped data for each case against the intervention logic model and then used Bhaskar's (2016) 'DREIC' analytic process to categorise cases according to extent of intervention delivery, outcomes evidenced, and contributing factors behind engagement or disengagement and progress achieved. RESULTS: There were variations in the dose and session focus of the intervention delivery, and how different participants responded. Participants sustaining long-term engagement and sustained change reached a state of 'crises but coping'. We found evidence that several components of the intervention were key to achieving this: trusting relationships, therapeutic work delivered well and over time; and an in-depth shared understanding of needs, concerns, and goals between the practitioner and participants. Those who disengaged were in one of the following states: 'Crises and chaos', 'Resigned acceptance', 'Honeymoon' or 'Wilful withdrawal'. CONCLUSIONS: We demonstrate that the 'implementability' of an intervention can be explained by examining the delivery of core intervention components in relation to the responses elicited in the participants. Core delivery mechanisms often had to be 'triggered' numerous times to produce sustained change. The improvements achieved, sustained, and valued by participants were not always reflected in the quantitative measures recorded in the RCT. The compatibility between the practitioner, participant and setting were continually at risk of being undermined by implementation failure as well as changing external circumstances and participants' own weaknesses. TRIAL REGISTRATION NUMBER: ISRCTN11707331, Wales Research Ethics Committee, Registered 02-04-2016-Retrospectively registered https://doi.org/10.1186/ISRCTN11707331.

Conducting Randomized Controlled Trials of Complex Interventions in Prisons: A Sisyphean Task?

Randomized Controlled Trials (RCT) are the "gold standard" for measuring the effectiveness of an intervention. However, they have their limitations and are especially complex in prison settings. Several systematic reviews have highlighted some of the issues, including, institutional constraints e.g., "lock-downs," follow-ups, contamination of allocation conditions and a reliance on self-report measures. In this article, we reflect on our experiences and will describe two RCTs. People in prison are a significantly disadvantaged and vulnerable group, ensuring equitable and effective interventions is key to reducing inequality and promoting positive outcomes. We ask are RCTs of complex interventions in prisons a sisyphean task? We certainly don't think so, but we propose that current accepted practice and research designs may be limiting our understanding and ability to test complex interventions in the real-world context of prisons. RCTs will always have their place, but designs need to be flexible and adaptive, with the development of other rigorous methods for evaluating impact of interventions e.g., non-randomized studies, including pre-post implementation studies. With robust research we can deliver quality evidence-based healthcare in prisons - after all the degree of civilization in a society is revealed by entering its prisons.

Comparison of a full arch digital photographic assessment of caries prevalence in 5-year-old children to an established visual assessment method: a cross-sectional study.

INTRODUCTION: Digital epidemiology in dental disease screening has a number of advantages which warrant further exploration. AIM: This study aimed to test the examination accuracy of digital images to evaluate child oral health by comparing the new method to a gold standard method. It also investigated the levels of diagnostic accuracy between different examiners, including dental care professionals and a lay examiner, when quantifying dental disease using images. METHODS: A calibrated dental examiner inspected forty 5-year-olds. In addition, three sets of digital images were taken per child. These images were assessed by six examiners. Sensitivity and specificity of caries diagnosis and inter-examiner reliability were calculated to compare the caries scores derived from examination of the images to those of the gold standard examinations. RESULTS: The mean values for sensitivity and specificity scores were 48.0% and 99.1%, respectively. The mean value for kappa showed moderate agreement between 0.43 and 0.73 (0.57). Mean values for agreement using intra-class coefficients were excellent (0.78) and good (0.73) for dt and dmft, respectively. No statistical difference in the validity of the caries scores was shown between the different image assessors. CONCLUSIONS: These data demonstrate the feasibility of using digital images to screen child oral health and for nondental professionals to be recruited to carry out digital epidemiology for the oral health surveillance of children.

Using multiple case studies of health and justice services to inform the development of a new complex intervention for prison-leavers with common mental health problems (Engager).

BACKGROUND: People in the criminal justice system have complex needs but often do not make use of services outside of prison, in many cases due to poorly joined up working between health and criminal justice services. The 'Engager' programme aimed to develop a complex collaborative care intervention for people leaving prison with common mental health problems that could support their transition into the community and facilitate joined up working between health, justice and social services. To augment our core intervention theory, we wanted to learn from innovative and forward-thinking services providing interagency support and/or treatment for people experiencing common mental health problems within the criminal justice system. We wanted to identify key elements of interagency practice to understand what was and was not effective in engaging people, maintaining their contact and improving mental health and other aspects of their lives. METHOD: We used a multiple case study design with a focused ethnographic approach in four study sites. Data came from three sources (documents, field notes and semi-structured interviews) underwent a framework analysis. RESULTS: We identified seven main themes, namely: collaboration, client engagement, client motivation, supervision, therapeutic approach, peers and preparations for ending. Engaging and motivating clients was dependent on the relationship built with the professional. This relationship was developed through building trust and rapport, which required time and respectful, open and honest communication. Professionals were often unable to build this relationship effectively if they did not work in effective interagency collaborations, particularly those which included shared practices and were supported by effective supervision. CONCLUSIONS: The multiple case study design contributed insights as to how health and justice services work together. The main themes identified are well known factors in health and justice co-working. However, the novel insights were gleaned examining interdependence and interactions in complex, multifactorial phenomena and practice, in particular the importance of shared practice and supervision models. The approach of selecting a small number of cases representing identified knowledge gaps contributed a valuable addition to the program theory and delivery for an innovative complex intervention.

A qualitative exploration of promoting oral health for infants in vulnerable families.

Introduction Oral disease in very young children is far more common among children in deprived and vulnerable families than among their peer group. Such children are at the highest risk of requiring a general anaesthetic for removal of decayed primary teeth.Aim This study aimed to create new knowledge about how best to promote oral health among a target population, about who very little is established with regard to how to successfully intervene to improve long-term oral health.Method Phase one of the study developed a logic model, and phase two delivered an oral health-promoting intervention by working with the Family Nurse Partnership. The social and empirical acceptability of the intervention was explored, and the attributes needed by people delivering such an intervention were investigated in-depth.Results The thematic analysis of phase one data produced seven key themes which appeared to influence parents' ability and willingness to accept an oral health intervention aimed at their infants. These were: their personal experiences, current oral health knowledge, desire for dental care for their child, the timing of an intervention, their perception of difficulties, family norms and the level of trust developed.Conclusion It is possible to motivate the most vulnerable families to establish behaviours which are conducive to good oral health, and that intervention is feasible and appropriate if a trusting relationship is adopted by the deliverer of the intervention. Families were successful in adopting oral health behaviours and visiting dental services when such circumstances were established.

Barriers and enablers to accessing dental services for people experiencing homelessness: A systematic review.

OBJECTIVES: The aim of this systematic review was to identify and conceptualize the barriers and enablers to accessing dental services for people experiencing homelessness in the United Kingdom. METHODS: A literature search for studies relevant to homelessness and dental care was conducted. The PRISMA and ENTREQ guidelines were followed. Electronic databases (EMBASE, MEDLINE, DOSS, CINAHL, SOCINDEX and PsycINFO) and grey literature sources (Electronic Theses Online Service - EThOS, Kings Fund, NICE Evidence, Open Grey, Google and the Health Foundation) were searched up to 28 August 2018. The critical appraisal was conducted using CASP and an adjusted version of a JBI Critical Appraisal tool. Thematic analysis was used to develop the themes and domains. RESULTS: Twenty-eight papers were included. Barriers to homeless people accessing dental care stemmed both from the lived experience of homelessness and the healthcare system. Within homelessness, the themes identified included complexity, emotions and knowledge. Regarding the healthcare system, identified themes included staff encounter, accessibility and organization issues. CONCLUSION: Homelessness can actively contribute to both an increased need for dental care and barriers to accessing that care. The arrangement of dental healthcare services can also act as barriers to care. This is the first systematic review to conceptualize the factors associated with access to dental care for people who are homeless. It provides a set of recommendations for overcoming the main barriers for homeless people to accessing dental care. It also offers directions for future research, policy and commissioning.

The feasibility of following up prisoners, with mental health problems, after release: a pilot trial employing an innovative system, for engagement and retention in research, with a harder-to-engage population.

BACKGROUND: Following up released prisoners is demanding, particularly for those prisoners with mental health problems, for whom stigma and chaotic lifestyles are problematic. Measurement of mental health outcomes after release is challenging. To evaluate mental healthcare for offender populations, using high-quality randomised controlled trials, evidenced-based methods must be developed to engage them while in custody, to locate and re-interview them after release, and to collect potentially stigmatising mental health outcomes data. METHODS: We developed an initial theoretical model and operational procedures for collecting baseline and follow-up data informed by a literature search, focus groups, and case studies. Male prisoners from five prisons in two sites were invited to participate. The inclusion criteria included individuals who were above threshold on nine-item Patient Health Questionnaire, seven-item Generalized Anxiety Disorder, or post-traumatic stress disorder scales, or who had reported mental health problems in the past 2 years or had been assessed with a likely personality disorder. Potential participants were interviewed to generate baseline data and were re-contacted before their release. We then contacted them for a follow-up interview, which included repeating the earlier data collection measures 2-8 weeks after release. A qualitative formative process evaluation produced and refined a model procedure for the recruitment and retention of male prison leavers in trials, identified the mechanisms which promoted engagement and retention, and mapped these against a theoretical behaviour change model. RESULTS: We developed a flexible procedure which was successful in recruiting male prison leavers to a pilot trial: 185/243 (76%, 95% confidence interval (CI) 70-81%) of those approached agreed to participate. We also retained 63% (95% CI 54-71%) of those eligible to participate in a follow-up interview 2-8 weeks after release. Mental health outcomes data was collected at both these time points. CONCLUSIONS: It is possible to design acceptable procedures to achieve sustained engagement critical for delivering and evaluating interventions in prison and in the community and to collect mental health outcomes data. These procedures may reduce attrition bias in future randomised controlled trials of mental health interventions for prison leavers. This procedure has been replicated and successfully delivered in a subsequent pilot trial and a definitive randomised controlled trial.

Engaging Without Exposing: Use of a Fictional Character to Facilitate Mental Health Talk in Focus Groups With Men Who Have Been Subject to the Criminal Justice System.

In an effort to encourage men with experience of being subject to the criminal justice system to contribute to focus group discussions on the sensitive topic of mental health, while also doing our utmost to protect them from discomfort or risk of exploitation, we used a novel technique involving the creation of a fictional character, supplemented by an audio-recorded vignette. We studied the role played by this technique in achieving our stated aims of "engaging without exposing." In this article, we report on the use of this technique in three focus groups, showing how in very different ways it shaped the interaction between participants and generated crucial insights into the lives and service needs of each group. We conclude that the technique may lend itself to being used in focus groups with other marginalized or seldom-heard populations.

Engaging "seldom heard" groups in research and intervention development: Offender mental health.

BACKGROUND: People subject to the criminal justice system often have substantially different life-experiences from the general population. Patient and public involvement (PPI) of "seldom heard" groups provides valuable experiential knowledge, enhancing research. OBJECTIVE: To share our jointly developed techniques to ensure the meaningful engagement and contribution of people with lived experience of the criminal justice system (PWLECJS) in research, trial science, intervention theory development and dissemination. METHODS: Commitment to adequate financial resources, appropriate staff skills and adequate time were combined with previous learning. PWLECJS were approached through local community organizations. A group was established and met fortnightly for ten months in an unthreatening environment and had a rolling membership. Ongoing engagement was promoted by the group taking responsibility for the rules, interactive and accessible activities, feeding back tangible impacts, ongoing contact, building a work ethic, joint celebrations, sessions with individual academic researchers and pro-actively managed endings. RESULTS: The Peer Researchers contributed to study documents, training academic researchers, research data collection and analysis, intervention delivery and theory development and trial science. The Peer Researchers gained in confidence and an improved sense of self-worth. The Academic Researchers gained skills, knowledge and an increased openness to being challenged. DISCUSSION AND CONCLUSIONS: PWLECJS can be meaningful included in health research and intervention development. The key elements required are listed. Challenges included differences in priorities for timescales and dissemination, resource limitations and the use of Peer Researchers' names. Further research is required to understand what might be of relevance for other "seldom heard" groups.

Health trainer-led motivational intervention plus usual care for people under community supervision compared with usual care alone: a study protocol for a parallel-group pilot randomised controlled trial (STRENGTHEN).

INTRODUCTION: People with experience of the criminal justice system typically have worse physical and mental health, lower levels of mental well-being and have less healthy lifestyles than the general population. Health trainers have worked with offenders in the community to provide support for lifestyle change, enhance mental well-being and signpost to appropriate services. There has been no rigorous evaluation of the effectiveness and cost-effectiveness of providing such community support. This study aims to determine the feasibility and acceptability of conducting a randomised trial and delivering a health trainer intervention to people receiving community supervision in the UK. METHODS AND ANALYSIS: A multicentre, parallel, two-group randomised controlled trial recruiting 120 participants with 1:1 individual allocation to receive support from a health trainer and usual care or usual care alone, with mixed methods process evaluation. Participants receive community supervision from an offender manager in either a Community Rehabilitation Company or the National Probation Service. If they have served a custodial sentence, then they have to have been released for at least 2 months. The supervision period must have at least 7 months left at recruitment. Participants are interested in receiving support to change diet, physical activity, alcohol use and smoking and/or improve mental well-being. The primary outcome is mental well-being with secondary outcomes related to smoking, physical activity, alcohol consumption and diet. The primary outcome will inform sample size calculations for a definitive trial. ETHICS AND DISSEMINATION: The study has been approved by the Health and Care Research Wales Ethics Committee (REC reference 16/WA/0171). Dissemination will include publication of the intervention development process and findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will also be disseminated to stakeholders and trial participants. TRIAL REGISTRATION NUMBERS: ISRCTN80475744; Pre-results.

Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial.

INTRODUCTION: The 'Engager' programme is a 'through-the-gate' intervention designed to support prisoners with common mental health problems as they transition from prison back into the community. The trial will evaluate the clinical and cost-effectiveness of the Engager intervention. METHODS AND ANALYSIS: The study is a parallel two-group randomised controlled trial with 1:1 individual allocation to either: (a) the Engager intervention plus standard care (intervention group) or (b) standard care alone (control group) across two investigation centres (South West and North West of England). Two hundred and eighty prisoners meeting eligibility criteria will take part. Engager is a person-centred complex intervention delivered by practitioners and aimed at addressing offenders' mental health and social care needs. It comprises one-to-one support for participants prior to release from prison and for up to 20 weeks postrelease. The primary outcome is change in psychological distress measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure at 6 months postrelease. Secondary outcomes include: assessment of subjective met/unmet need, drug and alcohol use, health-related quality of life and well-being-related quality of life measured at 3, 6 and 12 months postrelease; change in objective social domains, drug and alcohol dependence, service utilisation and perceived helpfulness of services and change in psychological constructs related to desistence at 6 and 12 months postrelease; and recidivism at 12 months postrelease. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action and look for unintended consequences. An economic evaluation will estimate the cost-effectiveness. ETHICS AND DISSEMINATION: This study has been approved by the Wales Research Ethics Committee 3 (ref: 15/WA/0314) and the National Offender Management Service (ref: 2015-283). Findings will be disseminated to commissioners, clinicians and service users via papers and presentations. TRIAL REGISTRATION NUMBER: ISRCTN11707331; Pre-results.

General practitioner contributions to achieving sustained healthcare for offenders: a qualitative study.

BACKGROUND: Offenders frequently have substantial healthcare needs and, like many other socially marginalised groups, often receive healthcare in inverse proportion to their needs. Improved continuity of healthcare over time could contribute to addressing these needs. General Practitioners need to be able to support people with complex social and medical problems, even in systems that are not specifically designed to manage individuals with such degrees of complexity. We aimed to examine offenders' perspectives on factors that contributed to, or worked against, creating and sustaining their access to healthcare. METHODS: From a sample of 200 participants serving community or prison sentences in South West (SW) and South East (SE) England, who were interviewed about their health care experiences as part of the Care for Offenders: Continuity of Access (COCOA) study, we purposively sampled 22 participants for this sub-study, based on service use. These interviews were transcribed verbatim. A thematic analytic approach initially applied 5 a priori codes based on access and different components of continuity. Data were then examined for factors that contributed to achieving and disrupting access and continuity. RESULTS: Participants described how their own life situations and behaviours contributed to their problems in accessing healthcare and also identified barriers created by existing access arrangements. They also highlighted how some General Practitioners used their initiative and skills to 'workaround' the system, and build positive relationships with them; feeling listened to and building trust were particularly valued, as was clear communication. Limitations faced by General Practitioners included a lack of appropriate services to refer people to, where the offender patients would meet the access criteria, and disagreements regarding medication prescriptions. CONCLUSIONS: General Practitioners can make a positive contribution to supporting access to healthcare for an under-served population by facilitating more flexible and less formal access arrangements, by using their relationship skills, and by problem-solving. General Practitioners should recognise their potential to transform people's experience of healthcare whilst working in imperfect systems, particularly with vulnerable and marginalised groups who have complex medical and social needs.

Pilot randomised controlled trial of the ENGAGER collaborative care intervention for prisoners with common mental health problems, near to and after release.

BACKGROUND: Rates of common mental health problems are much higher in prison populations, but access to primary care mental health support falls short of community equivalence. Discontinuity of care on release is the norm and is further complicated by substance use and a range of social problems, e.g. homelessness. To address these problems, we worked with criminal justice, third sector social inclusion services, health services and people with lived experiences (peer researchers), to develop a complex collaborative care intervention aimed at supporting men with common mental health problems near to and following release from prison. This paper describes an external pilot trial to test the feasibility of a full randomised controlled trial. METHODS: Eligible individuals with 4 to 16 weeks left to serve were screened to assess for common mental health problems. Participants were then randomised at a ratio of 2:1 allocation to ENGAGER plus standard care (intervention) or standard care alone (treatment as usual). Participants were followed up at 1 and 3 months' post release. Success criteria for this pilot trial were to meet the recruitment target sample size of 60 participants, to follow up at least 50% of participants at 3 months' post release from prison, and to deliver the ENGAGER intervention. Estimates of recruitment and retention rates and 95% confidence intervals (CIs) are reported. Descriptive analyses included summaries (percentages or means) for participant demographics, and baseline characteristics are reported. RESULTS: Recruitment target was met with 60 participants randomised in 9 months. The average retention rates were 73% at 1 month [95% CI 61 to 83] and 47% at 3 months follow-up [95% CI 35 to 59]. Ninety percent of participants allocated to the intervention successfully engaged with a practitioner before release and 70% engaged following release. CONCLUSIONS: This pilot confirms the feasibility of conducting a randomised trial for prison leavers with common mental health problems. Based on this pilot study and some minor changes to the trial design and intervention, a full two-centre randomised trial assessing the clinical and cost-effectiveness of the ENGAGER intervention is currently underway.

Western medical acupuncture in a group setting for knee osteoarthritis: results of a pilot randomised controlled trial.

BACKGROUND: Evidence suggests acupuncture may be effective for treating the symptoms of knee osteoarthritis. Offering this in a group setting may offer cost savings. The aim of this study was to establish the feasibility of a definitive trial to assess the clinical and cost-effectiveness of Western medical acupuncture given in groups, or given individually, for adults with severe knee pain attributable to osteoarthritis. METHODS: A pilot randomised controlled trial (RCT) was conducted. Participants were recruited from seven general practices in Plymouth, Devon. Acupuncture was provided, at a dosage that increased up to and including electroacupuncture if no pain relief was reported, by one experienced acupuncturist in a community clinic. Potentially eligible adults aged at least 45 years with knee osteoarthritis were identified from practice registers, screened and randomised to either: (1) standardised advice and exercise booklet alone ('standard'); (2) booklet plus group acupuncture ('group'); and (3) booklet plus individual acupuncture ('individual'). Both acupuncture arms received up to ten treatments over 12 weeks. Recruitment, retention and data completion rates were recorded, and participants completed questionnaires on acceptability. We collected pain, stiffness and function data (using the Western Ontario McMaster Universities Osteoarthritis Index; WOMAC) and general health (EQ-5D) and economic measures at baseline and 14 weeks post-randomisation. RESULTS: We screened 149 people and randomised 60 (40 %), 20 per arm. The overall 14 week follow-up rate was 77 %, but only 70 % in the 'standard' group; 4.1 % of data points were missing. The study was acceptable to participants. Changes in WOMAC pain score (intention to treat complete case analysis) from baseline to 14 week follow-up were: 'standard', 0.4 (95 % confidence interval (CI) -1.4, 2.2, n = 14); 'group' -3.2 (95 % CI -5.1, -1.4, n = 17); 'individual' -2.4 (95 % CI -4.1, -0.7, n = 15). CONCLUSIONS: A definitive three-arm trial is feasible. Further follow-up reminders, minimum data collection and incentives should be considered to improve participant retention in the follow-up processes in the standardised advice and exercise booklet arm. TRIAL REGISTRATION: ISRCTN05305406.

What IAPT services can learn from those who do not attend.

BACKGROUND: Rates of non-attendance within IAPT are 45-48%. Non-attendance has negative implications for patients, staff and services. AIMS: This research aimed to identify service-related factors that contribute to non-attendance. METHOD: Qualitative interviews with 14 patients recruited from six IAPT services in the South West. These were individuals who, having been referred to IAPT, never attended, or only attended one treatment contact. They were interviewed face-to-face or by telephone using semi-structured interview schedules. The resulting data were analysed thematically through an iterative qualitative analysis using data mapping sheets. RESULTS: Five themes emerged from an analysis of the data including: the waiting process, the relationship between IAPT services and GPs, expectations of assessment and treatment, rigidity of service and practitioner contributions to the relationship. CONCLUSIONS: The analysis identifies ways in which IAPT services could reduce non-attendance. It also highlights areas of interest for future non-attendance in healthcare research, particularly collaborative care and protocolisation of treatment.

The work and social adjustment scale: reliability, sensitivity and value.

OBJECTIVE: To investigate the psychometric properties of the Work and Social Adjustment Scale (WSAS) as an outcome measure for the Improving Access to Psychological Therapy programme, assessing its value as an addition to the Patient Health (PHQ-9) and Generalised Anxiety Disorder questionnaires (GAD-7). Little research has investigated these properties to date. METHODS: Reliability and responsiveness to change were assessed using data from 4,835 patients. Principal components analysis was used to determine whether the WSAS measures a factor distinct from the PHQ-9 and GAD-7. RESULTS: The WSAS measures a distinct social functioning factor, has high internal reliability, and is sensitive to treatment effects. CONCLUSIONS: The WSAS, PHQ-9 and GAD-7 perform comparably on measures of reliability and sensitivity. The WSAS also measures a distinct social functioning component suggesting it has potential as an additional outcome measure.