Create to Collaborate: using creative activity and participatory performance in online workshops to build collaborative research relationships.

BACKGROUND: Creative methods/practices have been highlighted as helpful to develop more collaborative, equitable research partnerships between researchers and communities/public-participants. We asked artist partners to design four online workshops, one on each research priority area: school environments and mental health; wellbeing within the Somali community; air pollution; health data. We aimed to understand whether creative processes can enable public-participants and researcher- participants to meet in a neutral space to discuss a research theme and begin to build collaborative relationships through more equal engagement. Ideas could be taken forwards with seed funding, providing opportunity for collaboration to continue beyond initial workshops. METHODS: Different artist partners designed and facilitated four workshops. Evaluation data was collected on each workshop using participatory observation and fieldnotes, alongside chatlog data, and one-to-one interviews with 21 workshop participants, providing a contextually rich, comparative evaluation across four diverse workshops. Analysis was thematically driven. RESULTS: Artist partners took different approaches to designing workshops. The workshops began with introductory games and activities, and there was less emphasis on introductions of people's roles, with the intention to avoid hierarchical dynamics. Whilst public-participants enjoyed this, some researchers found it challenging and reported confusions over their workshop roles. Disrupting usual practice and challenging norms was not always an easy experience. There were examples where emergent, co-created knowledge was enabled. However, it was more challenging to facilitate longer-term collaborative research projects from the workshops due to different stakeholder priorities, and lack of staff time/ less sense of ownership for further work. CONCLUSIONS: Creative activities can influence and impact the types of conversations between public-participants and researchers in a way that changes and challenges power dynamics, shifting towards public-participant driven discussion. Whilst deconstructing hierarchies is important, supporting researchers is key so that any discomfort can be productive and experienced as a vital part of co-production. Longer term collaborative research projects were limited, highlighting a need for facilitation beyond initial workshops, and a sense of ownership from workshop participants to take things forwards. Workshops like these may lend themselves well to research prioritisation. However, taking community-led ideas forwards within research funding landscapes remains challenging.

Create to Collaborate aimed to develop and facilitate creative public involvement workshops with members of the public, researchers, and community organisations, who were potentially interested in collaborating on a future health research project. We wanted to evaluate the extent to which creative, external facilitation by different artists could enable the development of more equal relationships and reduce power differences at the beginning of a research process. We worked with artists who designed and facilitated an online workshop, and community partners who helped recruit members of the public to increase diversity in participation. Then, we delivered and evaluated the workshops to understand different participants' experiences. Four workshops are reported in this article, each focused on a different topic: mental health in school environments, wellbeing in Bristol's Somali community, air pollution, and health data. We took observational notes at the workshops and conducted one-to-one qualitative interviews with 21 workshop participants. Feedback from public-participants taking part in creative workshops led by artist facilitators described them as 'engaging', 'comfortable' and 'equitable'. Researcher-participants reported workshops as 'open', 'inclusive' and 'engaging', whilst also reporting some confusion over what their own roles were and how much they could contribute as academic researchers. The project demonstrates a need for further clarity, particularly for researchers, over what roles may be in setting up a collaborative relationship, and possible disparity in expectations between those attending in an employment capacity and those joining as a public-participant in their own time.

Trauma-specific mindfulness-based cognitive therapy for women with post-traumatic stress disorder and a history of domestic abuse: intervention refinement and a randomised feasibility trial (coMforT study).

BACKGROUND: Women who have experienced domestic violence and abuse (DVA) are at increased risk of developing post-traumatic stress disorder (PTSD) and complex PTSD (CPTSD). In 2014-2015, we developed a prototype trauma-specific mindfulness-based cognitive therapy curriculum (TS-MBCT) for the treatment of PTSD in a DVA population. This study aimed to refine the prototype TS-MBCT and evaluate the feasibility of conducting a randomised controlled trial (RCT) testing its effectiveness and cost-effectiveness. METHODS: Intervention refinement phase was informed by evidence synthesis from a literature review, qualitative interviews with professionals and DVA survivors, and a consensus exercise with experts in trauma and mindfulness. We tested the refined TS-MBCT intervention in an individually randomised parallel group feasibility trial with pre-specified progression criteria, a traffic light system, and embedded process and health economics evaluations. RESULTS: The TS-MBCT intervention consisted of eight group sessions and home practice. We screened 109 women in a DVA agency and recruited 20 (15 TS-MBCT, 5 self-referral to National Health Service (NHS) psychological treatment), with 80% follow-up at 6 months. Our TS-MBCT intervention had 73% uptake, 100% retention, and high acceptability. Participants suggested recruitment via multiple agencies, and additional safety measures. Randomisation into the NHS control arm did not work due to long waiting lists and previous negative experiences. Three self-administered PTSD/CPTSD questionnaires produced differing outcomes thus a clinician administered measure might work better. We met six out of nine feasibility progression criteria at green and three at amber targets demonstrating that it is possible to conduct a full-size RCT of the TS-MBCT intervention after making minor amendments to recruitment and randomisation procedures, the control intervention, primary outcomes measures, and intervention content. At 6 months, none of the PTSD/CPTSD outcomes ruled out a clinically important difference between trial arms indicating that it is reasonable to proceed to a full-size RCT to estimate these outcomes with greater precision. CONCLUSIONS: A future RCT of the coMforT TS-MBCT intervention should have an internal pilot, recruit from multiple DVA agencies, NHS and non-NHS settings, have an active control psychological treatment, use robust randomisation and safety procedures, and clinician-administered measures for PTSD/CPTSD. TRIAL REGISTRATION: ISRCTN64458065 11/01/2019.

Romanian young adult perceptions on using heated tobacco products following exposure to direct marketing methods.

Heated tobacco products have a rapid uptake, especially among young people, mostly where advertising is unregulated, as is the case in Romania. This qualitative study explores the influence of direct marketing methods of heated tobacco products on young people, their perception and behaviour towards smoking. We have carried out 19 interviews with smokers of heated tobacco products (HTPs) or/and combustible cigarettes (CCs) or non-smokers (NS), aged 18-26. Using the thematic analysis, we have identified three overarching themes: (1) people, places, and subjects of marketing, (2) engagement with risk narratives and (3) social body, family bonds, and autonomous self. Even if most of the participants have been exposed to a mix of marketing methods, they did not acknowledge the influence that marketing has on their decision to experience smoking. Young adults' decision to use heated tobacco products seems to be influenced by a cluster of reasons: overcoming the legislation gap which prohibits indoor use of combustible cigarettes but not heated tobacco products; the attractivity of the product (novelty, inviting appearance, technological appeal and price) and presumed less damaging effects on health.

Understanding ethnic inequalities in mental healthcare in the UK: A meta-ethnography.

BACKGROUND: Evidence regarding the presence and persistence of ethnic inequalities in mental healthcare is well established. The reasons for these inequalities and lack of progress in diminishing them are less understood. This meta-ethnography aims to provide a new conceptual understanding of how ethnic inequalities are created and sustained; this is essential to develop effective interventions. Specifically, we sought to understand why people from ethnic minority groups are underrepresented in primary care mental health service provision and overrepresented in crisis pathways and detention. METHODS AND FINDINGS: Following eMERGe guidelines for meta-ethnographies, we searched OpenGrey, Kings Fund, CINAHL, Medline, PsycINFO, and Social Care Online databases for qualitative articles published from database inception until October 2, 2022, using broad categories of search terms relating to "ethnicity AND (mental illness/mental health/emotional distress) AND (help-seeking/service utilisation/experience/perception/view)." We included all conceptually rich articles that used qualitative methods of data collection and analysis and excluded non-UK studies and those that focused solely on causation of mental illness. Our patient, public, and practitioner lived experience advisory group provided feedback and input on key stages of the project including search terms, research questions, data analysis, and dissemination. A total of 14,142 articles were identified; 66 met the inclusion criteria. We used reciprocal, refutational, and line of argument analytical approaches to identify convergence and divergence between studies. The synthesis showed that current models of statutory mental healthcare are experienced as a major barrier to the delivery of person-centred care to those in ethnic minority groups due to the perceived dominance of monocultural and reductionist frameworks of assessment and treatment (described as "medical" and "Eurocentric") and direct experiences of racist practice. The lack of socially oriented and holistic frameworks of knowledge and understanding in medical training and services is experienced as epistemic injustice, particularly among those who attribute their mental illness to experiences of migration, systemic racism, and complex trauma. Fear of harm, concerns about treatment suitability, and negative experiences with health providers such as racist care and medical neglect/injury contribute to avoidance of, and disengagement from, mainstream healthcare. The lack of progress in tackling ethnic inequalities is attributed to failures in coproduction and insufficient adoption of existing recommendations within services. Study limitations include insufficient recording of participant characteristics relating to generational status and social class in primary studies, which prevented exploration of these intersections. CONCLUSIONS: In this study, we found that the delivery of safe and equitable person-centred care requires a model of mental health that is responsive to the lived experiences of people in ethnic minority groups. For the people considered in this review, this requires better alignment of mental health services with social and anti-racist models of care. Our findings suggest that intersections related to experiences of racism, migration, religion, and complex trauma might be more relevant than crude ethnic group classifications. Strategies to tackle ethnic inequalities in mental healthcare require an evaluation of individual, systemic, and structural obstacles to authentic and meaningful coproduction and implementation of existing community recommendations in services.

Perceptions on Home-Administration of Biologics in the Context of Severe Asthma: An International Qualitative Study.

BACKGROUND: Biologics are an effective therapy for severe asthma. Home administration of biologics by patients is likely to facilitate their accessibility. Yet little is known about patients' and health care providers' (HCPs) perceptions regarding home administration of biologics. OBJECTIVE: The aim of this study is to create more insight into the perceptions and experiences of patients and HCPs regarding home administration of biologics in the context of the treatment of severe asthma. METHODS: A qualitative international study was performed in the Netherlands, United States, Australia, and United Kingdom. In each country, 2 focus groups were held with potential/recent and long-term users of biologics at home. Prior to the focus groups, patients were prompted with themes on online forums. For triangulation purposes, interviews were held with HCPs to discuss salient findings from forums and focus groups. Data were analyzed with qualitative content analysis. RESULTS: In total, 75 patients participated in the forums, of which 40 participated in the focus groups. Furthermore, 12 HCPs were interviewed. The following overarching themes were identified: living with severe asthma; practical aspects of using biologics; the role of HCPs regarding biologics; social support from family, friends, and others; effectiveness of biologics and other treatments; side effects of biologics. CONCLUSIONS: This study showed that, for those using biologics for severe asthma, the benefits of home administration of biologics usually outweigh inconvenience and side effects. Guided practice, accessible support contact, and monitoring including social support should be central in the transition from hospital to home administration of asthma biologics.

'The body says it': the difficulty of measuring and communicating sensations of breathlessness.

Breathlessness is a sensation affecting those living with chronic respiratory disease, obesity, heart disease and anxiety disorders. The Multidimensional Dyspnoea Profile is a respiratory questionnaire which attempts to measure the incommunicable different sensory qualities (and emotional responses) of breathlessness. Drawing on sensorial anthropology we take as our object of study the process of turning sensations into symptoms. We consider how shared cultural templates of 'what counts as a symptom' evolve, mediate and feed into the process of bodily sensations becoming a symptom. Our contribution to the field of sensorial anthropology, as an interdisciplinary collaboration between history, anthropology and the medical humanities, is to provide a critique of how biomedicine and cultures of clinical research have measured the multidimensional sensorial aspects of breathlessness. Using cognitive interviews of respiratory questionnaires with participants from the Breathe Easy groups in the UK, we give examples of how the wording used to describe sensations is often at odds with the language those living with breathlessness understand or use. They struggle to comprehend and map their bodily experience of sensations associated with breathlessness to the words on the respiratory questionnaire. We reflect on the alignment between cognitive interviewing as a method and anthropology as a disciplinary approach. We argue biomedicine brings with it a set of cultural assumptions about what it means to measure (and know) the sensorial breathless body in the context of the respiratory clinic (clinical research). We suggest the mismatch between the descriptions (and confusion) of those responding to the respiratory questionnaire items and those selecting the vocabularies in designing it may be symptomatic of a type of historical testimonial epistemic injustice, founded on the prioritisation of clinical expertise over expertise by experience.

Dear Breath: using story structure to understand the value of letter writing for those living with breathlessness - a qualitative study.

Background: Despite the prevalence of dyspnoea (the pathological term for breathlessness) amongst the general population and the diagnostic importance of dyspnoea for respiratory illness, public awareness of dyspnoea is poor with an estimated two million people with undiagnosed Chronic Obstructive Pulmonary Disorder in the UK. We explore whether therapeutic letter writing is a valuable arts health approach for those living with breathlessness. Methods: Eighty (80) participants took part in 10 workshops held in community-based settings. The overall approach was qualitative. We analysed the data thematically. Results: Informed by theories of story structure, our analysis explores letters written to the breath in terms of there being a protagonist, antagonist, a process of recognition and reconciliation. Conclusions: Writing a letter to the breath facilitates new ways of relating to breathlessness. Letters create a personal narrative and workshops create a public story. Further research should explore whether therapeutic letter writing can support communication about breathlessness with clinicians.

Help seeking by male victims of domestic violence and abuse: an example of an integrated mixed methods synthesis of systematic review evidence defining methodological terms.

BACKGROUND: Domestic violence and abuse is a violation of human rights which damages the health and wellbeing of victims, their families and their friends. There has been less research on the experiences and support needs of male victims than those of women. Historically research on men's experiences has not focused on what constitutes effective, needs-led service provision. The aim of this paper was to conduct an integrated mixed methods synthesis of systematic review evidence on the topic of help-seeking by male victims of domestic violence and abuse. METHODS: An integrated mixed methods synthesis approach was taken to enhance our understanding of the complex phenomenon of help seeking by, and service provision to male victims. This process also identifies gaps in the evidence. Using previously identified systematic review data; mixed methods data from four primary-level service evaluation studies, along with expert and patient consultation were used to develop research propositions. Primary-level qualitative interview and survey data from 12 studies of men experiences were mapped onto the propositions to support them. RESULTS: Fourteen propositions were composed. Seven propositions were supported or at least partly supported by the qualitative data. These supported propositions were used to make recommendations for policy and practice particularly concerning service preferences of male victims. The remaining seven propositions were not specifically supported by the qualitative data. These unsupported propositions were used to develop research recommendations concerning the need to further understand the potential blurred boundaries of victim-perpetrator, hybrid perpetrator-victim experiences, men who are/have been victims of childhood sexual abuse and determining the level of risk for men. They also highlight the need to produce better guidance for the response of the police & the criminal justice system. Finally, they highlight the need to produce the most appropriate service for men in terms of access, linkage, substance/alcohol abuse, mental health, sexuality, and race. CONCLUSION: Integrated mixed-methods synthesis of systematic review evidence is a relatively novel approach. This approach can lead to recommendations for policy and practice as well as highlighting gaps in the research agenda as shown in this example.

The coMforT study of a trauma-informed mindfulness intervention for women who have experienced domestic violence and abuse: a protocol for an intervention refinement and individually randomized parallel feasibility trial.

BACKGROUND: Domestic violence and abuse (DVA) is common and destructive to health. Post-traumatic stress disorder (PTSD) is a major mental health consequence of DVA. People who have experienced DVA have specific needs, arising from the repeated and complex nature of the trauma. The National Institute for Health and Care Excellence recommends more research on the effectiveness of psychological interventions for people who have experienced DVA. There is growing evidence that mindfulness-based interventions may help trauma symptoms. METHODS: Intervention refinement and randomized controlled feasibility trial. A prototype trauma-informed mindfulness-based cognitive therapy (TI-MBCT) intervention will be co-produced following qualitative interviews and consensus exercise with stakeholders. Participants in the feasibility trial will be recruited from DVA agencies in two geographical regions and randomized to receive either TI-MBCT or usual care (self-referral to the Improving Access to Psychological Therapies (IAPT) service). TI-MBCT will be delivered as a group-based eight-week program. It will not be possible to blind the participants or the assessors to the study allocation. The following factors will inform the feasibility of progressing to a fully powered trial: recruitment, retention, intervention fidelity, and the acceptability of the intervention and trial design to participants. We will also test the feasibility of measuring the following participant outcomes before and 6 months post-randomization: PTSD, dissociative symptoms, depression, anxiety, DVA re-victimization, self-compassion, and mother-reported child health. Process evaluation and economic analysis will be embedded within the feasibility trial. DISCUSSION: This study will lead to the development of a TI-MBCT intervention for DVA survivors with PTSD and inform the feasibility and design of a fully powered randomized controlled trial (RCT). The full trial will aim to determine the effectiveness and cost-effectiveness of a TI-MBCT intervention in improving the clinically important symptoms of PTSD in DVA survivors. TRIAL REGISTRATION: ISRCTN, ISRCTN64458065, Registered 11 January 2019.

Disrupted breath, songlines of breathlessness: an interdisciplinary response.

Health research is often bounded by disciplinary expertise. While cross-disciplinary collaborations are often forged, the analysis of data which draws on more than one discipline at the same time is underexplored. Life of Breath, a 5-year project funded by the Wellcome Trust to understand the clinical, historical and cultural phenomenology of the breath and breathlessness, brings together an interdisciplinary team, including medical humanities scholars, respiratory clinicians, medical anthropologists, medical historians, cultural theorists, artists and philosophers. While individual members of the Life of Breath team come together to share ongoing work, collaborate and learn from each other's approach, we also had the ambition to explore the feasibility of integrating our approaches in a shared response to the same piece of textual data. In this article, we present our pluralistic, interdisciplinary analysis of an excerpt from a single cognitive interview transcript with a patient with chronic obstructive pulmonary disease. We discuss the variation in the responses and interpretations of the data, why research into breathlessness may particularly benefit from an interdisciplinary approach, and the wider implications of the findings for interdisciplinary research within health and medicine.

Help-seeking by male victims of domestic violence and abuse (DVA): a systematic review and qualitative evidence synthesis.

OBJECTIVES: To understand help-seeking by male victims of domestic violence and abuse (DVA) and their experiences of support services by systematically identifying qualitative and mixed-method studies and thematically synthesising their findings. DESIGN: Systematic review and qualitative evidence synthesis. Searches were conducted in 12 databases and the grey literature with no language or date restrictions. Quality appraisal of the studies was carried out using the Critical Appraisal Skills Programme tool. Reviewers extracted first and second order constructs related to help-seeking, identified themes and combined them by interpretative thematic synthesis. SETTING: DVA experienced by male victims and defined as any incident or pattern of incidents of controlling coercive or threatening behaviour, violence or abuse among people aged 18 or over who are or have been intimate partners or family members, regardless of gender or sexuality. PARTICIPANTS: Male victims of DVA. INTERVENTIONS: Any intervention which provides practical and/or psychological support to male victims of DVA including but not limited to DVA-specific services, primary healthcare and sexual health clinics. PRIMARY AND SECONDARY OUTCOME MEASURES: Qualitative data describing help-seeking experiences and interactions with support services of male victims of domestic violence RESULTS: We included twelve studies which were published between 2006 and 2017. We grouped nine themes described over two phases (a) barriers to help-seeking: fear of disclosure, challenge to masculinity, commitment to relationship, diminished confidence/despondency and invisibility/perception of services; and (b) experiences of interventions and support: initial contact, confidentiality, appropriate professional approaches and inappropriate professional approaches. CONCLUSION: The recent publication of the primary studies suggests a new interest in the needs of male DVA victims. We have confirmed previously identified barriers to help-seeking by male victims of DVA and provide new insight into barriers and facilitators to service provision. PROSPERO REGISTRATION NUMBER: CRD42016039999.

Medical Students' Experience of Mindfulness Training in the UK: Well-Being, Coping Reserve, and Professional Development.

Medical school can be a stressful experience for students, resulting in stress-related mental health problems. Policy recommendations from the General Medical Council (GMC), the body responsible for improving medical education in the UK, recommend the use of mindfulness training to increase well-being and resilience to stress. Students participating in an eight-week mindfulness training between Autumn 2011 and Spring 2015 were invited to complete a free text survey at the end of their mindfulness course. In addition, six qualitative interviews were conducted lasting between 60 and 90 minutes. Interviews used a topic guide and were recorded and transcribed verbatim. We used the framework approach to analyse the data. Students reported a new relationship to their thoughts and feelings which gave a greater sense of control and resiliency, an ability to manage their workload better, and more acceptance of their limitations as learners. The small group context was important. Students described improved empathy and communication skills through building inner awareness of thoughts and feelings, noticing judgments, and developing attentive observation. The findings show how resiliency and coping reserve can be developed within medical education and the role of mindfulness in this process. We present a conceptual model of a learnt cycle of specific vulnerability and describe how MBCT intercepts at various junctures in this self-reinforcing cycle through the development of new coping strategies that embrace an "allowed vulnerability."

Women's experiences of a randomised controlled trial of a specialist psychological advocacy intervention following domestic violence: A nested qualitative study.

BACKGROUND: Women's experience of domestic violence and abuse (DVA) is associated with mental illness which may not be addressed by domestic violence advocacy. The study aimed to compare the experiences of women receiving a psychological intervention with women receiving usual advocacy in a randomized controlled trial (PATH: Psychological Advocacy Towards Healing), to illuminate the trial results by exploring women's experiences of benefits and difficulties. METHODS: A qualitative study nested within the PATH trial, based in two DVA agencies in the UK. A purposive sample of thirty-one intervention and usual care participants were interviewed up to three interviews over a year. Thematic analysis was carried out, incorporating concepts from the Trans-Theoretical Model of change. FINDINGS: The PATH trial reports a clinically relevant improvement in mental health outcomes for women receiving the intervention compared to usual advocacy. The qualitative study reveals which elements of the intervention were beneficial or problematic, which outcomes were most meaningful and relevant to participants and highlights reasons for variations in adherence. Women valued the educational, psychological and emotional elements of the intervention, they felt safe to explore repressed emotions for the first time and experienced a reduction in self-blame, improved sense of identity and greater self-esteem. They also incorporated new skills and self-help techniques to enable sustainable change. Women receiving usual advocacy reported un-met needs for psychological and emotional support. Adherence was affected by women's 'psychological 'readiness' to engage, the competing demands of practical issues such as housing insecurity, legal proceedings or the availability of child care, and breaks in the continuity of professional care. CONCLUSIONS: Continuity and regularity of sessions with a trained specialist worker was key to women's recovery. Individual assessment of 'readiness' would optimise the timing of delivery to maximise adherence and benefit.

Understanding changes in dyspnoea perception in obstructive lung disease after mindfulness training.

INTRODUCTION: Dyspnoea has been defined as a 'subjective experience of breathing discomfort that consists of qualitatively distinct sensations that vary in intensity'. However, the majority of available dyspnoea measures treat it as a single entity and rely on quantitative methodology. We propose that qualitative research can enhance our understanding of dyspnoea, in particular, how perception varies so much among patients with similar disease states. In this paper, we focus on how a specific type of inner attention-mindfulness-may alter perceptions of dyspnoea. The aim is to characterise mindfulness attention, which impacts on perceptions of dyspnoea and relate these to the multidimensional model of dyspnoea. We explore how an individual can change their perception and therefore relationship to similar disease states. METHOD: 22 patients with asthma or chronic obstructive pulmonary disease were recruited from primary and secondary care to an 8-week course in mindfulness-based cognitive therapy (MBCT). 12 patients took part in an in-depth qualitative interview 2 months after completing the MBCT course. Data were recorded, transcribed and then analysed using a framework approach, drawing on components of the multidimensional model of dyspnoea (multidimensional dyspnoea profile, MDP). RESULTS: We found that MBCT training involves developing three types of mindful attention (broad attention, informative attention and re-directive attention), which impact on perceptions of the sensory dimension of dyspnoea. MBCT appears to target affective and sensory perceptions articulated in the MDP model. CONCLUSION: More research is needed into how mindfulness-based interventions may mediate the relationship between affective experience and the sensory perception of dyspnoea symptoms.

"I've made this my lifestyle now": a prospective qualitative study of motivation for lifestyle change among people with newly diagnosed type two diabetes mellitus.

BACKGROUND: Diagnosis with Type 2 Diabetes is an opportunity for individuals to change their physical activity and dietary behaviours. Diabetes treatment guidelines recommend theory-based, patient-centred care and advocate the provision of support for patient motivation but the motivational experiences of people newly diagnosed with diabetes have not been well studied. Framed in self-determination theory, this study aimed to qualitatively explore how this patient group articulate and experience different types of motivation when attempting lifestyle change. METHODS: A secondary analysis of semi-structured interview data collected with 30 (n female = 18, n male = 12) adults who had been newly diagnosed with type two diabetes and were participants in the Early ACTID trial was undertaken. Deductive directed content analysis was performed using NVivo V10 and researcher triangulation to identify and describe patient experiences and narratives that reflected the motivation types outlined in self-determination theory and if/how these changed over time. RESULTS: The findings revealed the diversity in motivation quality both between and within individuals over time and that patients with newly-diagnosed diabetes have multifaceted often competing motivations for lifestyle behaviour change. Applying self-determination theory, we identified that many participants reported relatively dominant controlled motivation to comply with lifestyle recommendations, avoid their non-compliance being "found out" or supress guilt following lapses in behaviour change attempts. Such narratives were accompanied by experiences of frustrating slow behaviour change progress. More autonomous motivation was expressed as something often achieved over time and reflected goals to improve health, quality of life or family time. Motivational internalisation was evident and some participants had integrated their behaviour change to a new way of life which they found resilient to common barriers. CONCLUSIONS: Motivation for lifestyle change following diagnosis with type two diabetes is complex and can be relatively low in self-determination. To achieve the patient empowerment aspirations of current national health care plans, intervention developers, and clinicians would do well to consider the quality not just quantity of their patients' motivation. TRIAL REGISTRATION: ISRCTN ISRCTN92162869 . Retrospectively registered.

Written action plans for children with long-term conditions: A systematic review and synthesis of qualitative data.

BACKGROUND: Long-term conditions (LTCs) in children require a high level of self-management. Written action plans (WAPs) have been advocated to guide decision-making and support self-management but there is uncertainty about how WAPs "work" and what aspects are important for successful implementation. OBJECTIVE: To review and synthesize existing qualitative evidence about the design and use of WAPs across childhood LTCs. METHOD: We undertook a systematic search of the literature (Medline, EMBASE, CiNAHL, PsycInfo, Web of science) from inception to May 2015; critically appraised included studies; and synthesized the findings, drawing on normalisation process theory. RESULTS: 3473 titles were screened and 53 papers read in full. Nine studies (four key, two minor and three of poor quality) contributed to our analysis, predominantly work on asthma from the USA and in specialist settings. WAPs may help to alleviate user worry and boost confidence. Confidence to act was closely linked to feelings of responsibility and authority. The value and use of WAPs are determined by multiple factors, and varies between different user groups. Logistical challenges include sharing a WAP between different stakeholders and keeping it up to date. Colour coding and pictures may enhance the appeal and usability of WAPS. CONCLUSION: WAPs are complex interventions but our understanding of their use and value in children with LTCs is limited. WAPs need to meet the needs of users who have different requirements/levels of understanding and confidence according to their different roles. Future research into WAPs needs to be both disease and context-specific.

A randomised controlled trial assessing the severity and duration of depressive symptoms associated with a clinically significant response to sertraline versus placebo, in people presenting to primary care with depression (PANDA trial): study protocol for a randomised controlled trial.

BACKGROUND: Depressive symptoms are usually managed within primary care and antidepressant medication constitutes the first-line treatment. It remains unclear at present which people are more likely to benefit from antidepressant medication. This paper describes the protocol for a randomised controlled trial (PANDA) to investigate the severity and duration of depressive symptoms that are associated with a clinically significant response to sertraline compared to placebo, in people presenting to primary care with depression. METHODS/DESIGN: PANDA is a randomised, double blind, placebo controlled trial in which participants are individually randomised to sertraline or placebo. Eligible participants are those who are between the ages of 18 to 74; have presented to primary care with depression or low mood during the past 2 years; have not received antidepressant or anti-anxiety medication in the 8 weeks prior to enrolment in the trial and there is clinical equipoise about the benefits of selective serotonin reuptake inhibitor (SSRI) medication. Participants who consent to participate in the trial are randomised to receive either sertraline or matching placebo, starting at 50 mg daily for 1 week, increasing to 100 mg daily for up to 11 weeks (with the option of increasing to 150 mg if required). Participants, general practitioners (GPs) and the research team will be blind to treatment allocation. The primary outcome will be depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) at 6 weeks post randomisation, measured as a continuous outcome. Secondary outcomes include depressive symptoms measured with the PHQ-9 at 2 and 12 weeks as a continuous outcome and at 2, 6 and 12 weeks as a binary outcome; follow-up scores on depressive symptoms measured with the Beck Depression Inventory-II, anxiety symptoms measured by the Generalized Anxiety Disorder-7 and quality of life measured with the Euroqol-5D-5L and Short Form-12; emotional processing task scores measured at baseline, 2 and 6 weeks; and costs associated with healthcare use, time off work and personal costs. DISCUSSION: The PANDA trial uses a simple self-administered measure to establish the severity and duration of depressive symptoms associated with a clinically significant response to sertraline. The evidence from the trial will inform primary care prescribing practice by identifying which patients are more likely to benefit from antidepressants. TRIAL REGISTRATION: Controlled Trials ISRCTN Registry, ISRCTN84544741 . Registered on 20 March 2014. EudraCT Number: 2013-003440-22; Protocol Number: 13/0413 (version 6.1).

Why are there discrepancies between depressed patients' Global Rating of Change and scores on the Patient Health Questionnaire depression module? A qualitative study of primary care in England.

OBJECTIVES: Our aims were to investigate discrepancies between depressed patients' GlobalRating of Change (GRC) and scores on the Patient Health Questionnaire depression module (PHQ-9). Our objectives were to ascertain patients' views on the source and meaning of mismatches and assess their clinical significance. DESIGN: Qualitative study nested within a cohort, in a programme investigating the indications for prescribing antidepressants that will lead to a clinical benefit. SETTING: Primary care practices in north-west England. PARTICIPANTS: We invited 32 adults with a recent diagnosis of depression and evidence of mismatch between GRC and PHQ-9 Scores to participate. Of these, 29 completed our interviews; most were women, identified as white British, had high school education or higher, were employed or retired and had been depressed for a long time. MAIN MEASURES: We conducted semistructured interviews with a topic guide, focusing on experiences of depression; treatment experiences and expectations; effectiveness of the questionnaires; reasons for the mismatch; and social factors. Interviews were transcribed and subjected to interpretative phenomenological analysis. RESULTS: We identified four themes as explanations for mismatch between GRC and PHQ-9: perceptions that GRC provided a more accurate assessment of current mental state than PHQ-9; impact of recent negative or positive life events on either measure; personal understanding of depression as normally fluctuating, and tendency to underscore on PHQ-9 as a means of self-motivation; and lack of recall. CONCLUSIONS: The combined used of the PHQ-9 and a more open question better captures the patient's unique experiences of mental health. This approach ascertains the relevance of symptoms to the individual's experience and influences treatment decisions. STUDY REGISTRATION: This study was an element of NIHR Programme Grant RP-PG 0610 10048.

Usefulness of PHQ-9 in primary care to determine meaningful symptoms of low mood: a qualitative study.

BACKGROUND: Self-administered questionnaires, such as the Patient Health Questionnaire (PHQ-9), are regularly used in clinical practice to guide prescribing or to measure recovery and response to treatment. There are concerns that patients are not all interpreting the questionnaire items in the same way. Cognitive interviewing is a research technique that identifies 'interpretative measurement error' (IME). IME is distinct from traditional components of measurement error, such as not reading the question as worded, or recording answers inaccurately. AIM: To use cognitive interviewing techniques to explore patterns in answer mapping and comprehension of the PHQ-9 questionnaire to ascertain whether the measure captures meaningful symptoms of low mood. DESIGN AND SETTING: Qualitative study using cognitive interviewing techniques and card sorting in six GP practices in Bristol. METHOD: The study recruited 18 participants at the point of entry to a longitudinal primary care depression cohort study, PANDA (the indications for Prescribing ANtiDepressants that will leAd to a clinical benefit). Participants were interviewed 2, 4, and 6 weeks after their baseline visit. Cognitive interviews were digitally recorded. Analysis used the digital audio file, rather than verbatim transcripts, as it retained important features needed for analyses. RESULTS: Cognitive interviewing revealed that items on the PHQ-9 are interpreted in a range of ways, that patients often cannot 'fit' their experience into the response options, and therefore often feel the questionnaire is misrepresenting their experience of meaningful symptoms of low mood. CONCLUSION: The PHQ-9 may be missing the presence and/or intensity of certain symptoms that are meaningful to patients. Clinicians should adopt caution when using it.