Synthesizing Qualitative Data Sets to Improve the Design of Trials and Complex Health Interventions: A Worked Example.

Qualitative researchers are increasingly reanalyzing and synthesizing data sets from different studies, and this method has now been used across trials to inform trial methodology and delivery. Despite this work, however, limited guidance exists about how this method should be employed. This article details an example in which interview data collected during three primary care depression trials were brought together to explore trial participants' study and treatment journeys. It details the process involved and the decisions made. It also presents findings from this synthesis to illustrate how this method can be used to inform the development of future trials and complex interventions, through raising questions about how researchers currently define and design treatment arms and indicating what factors may improve or hinder participants' engagement with their allocated treatment.

Interventions to support shared decision making for hypertension: A systematic review of controlled studies.

BACKGROUND: Hypertension (high blood pressure) is a common long-term health condition. Patient involvement in treating and monitoring hypertension is essential. Control of hypertension improves population cardiovascular outcomes. However, for an individual, potential benefits and harms of treatment are finely balanced. Shared decision making has the potential to align decisions with the preferences and values of patients. OBJECTIVE: Determine the effectiveness of interventions to support shared decision making in hypertension. SEARCH STRATEGY: Searches in MEDLINE, EMBASE, CINAHL, Web of Science and PsycINFO up to 30 September 2017. ELIGIBILITY CRITERIA: Controlled studies evaluating the effects of shared decision-making interventions for adults with hypertension compared with any comparator in any setting and reporting any outcome measures. RESULTS: Six studies (five randomized controlled trials) in European primary care were included. Main intervention components were as follows: training for health-care professionals, decision aids, patient coaching and a patient leaflet. Four studies, none at low risk of bias, reported a measure of shared decision making; the intervention increased shared decision making in one study. Four studies reported blood pressure between 6 months and 3 years after the intervention; there was no difference in blood pressure between intervention and control groups in any study. Lack of comparability between studies prevented meta-analysis. CONCLUSIONS: Despite widespread calls for shared decision making to be embedded in health care, there is little evidence to inform shared decision making for hypertension, one of the most common conditions managed in primary care.

"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.

Individuals' Long Term Use of Cognitive Behavioural Skills to Manage their Depression: A Qualitative Study.

BACKGROUND: Cognitive Behavioural Therapy (CBT) aims to teach people skills to help them self-manage their depression. Trial evidence shows that CBT is an effective treatment for depression and individuals may experience benefits long-term. However, there is little research about individuals' continued use of CBT skills once treatment has finished. AIMS: To explore whether individuals who had attended at least 12 sessions of CBT continued to use and value the CBT skills they had learnt during therapy. METHOD: Semi-structured interviews were held with participants from the CoBalT trial who had received CBT, approximately 4 years earlier. Interviews were audio-recorded, transcribed and analysed thematically. RESULTS: 20 participants were interviewed. Analysis of the interviews suggested that individuals who viewed CBT as a learning process, at the time of treatment, recalled and used specific skills to manage their depression once treatment had finished. In contrast, individuals who viewed CBT only as an opportunity to talk about their problems did not appear to utilize any of the CBT skills they had been taught and reported struggling to manage their depression once treatment had ended. CONCLUSIONS: Our findings suggest individuals may value and use CBT skills if they engage with CBT as a learning opportunity at the time of treatment. Our findings underline the importance of the educational model in CBT and the need to emphasize this to individuals receiving treatment.

Mothers' views of their preschool child's screen-viewing behaviour: a qualitative study.

BACKGROUND: Research on screen-viewing in preschool children has predominantly focused on television viewing. The rapid development of mobile devices (e.g. tablets, smart phones and e-readers) and the increase in their use by preschool children means there is a need to understand how and why these devices are used by this age group. The aim of this study was to explore mothers' views of their preschool children's screen viewing behaviour (including mobile devices) and investigate how preschool children use different screen-viewing devices. METHODS: One-to-one, semi-structured interviews with mothers of preschool children (aged between 2 and 4 years old). Mothers were recruited through preschools, nurseries, and mother and toddler groups located within four areas of varying socio-economic status within Bristol, UK. Data were analysed thematically using a framework approach. RESULTS: Twenty-six mothers were interviewed. Mobile devices were regularly used as a form of screen-viewing for most children but were used on an ad hoc basis rather than being a habitual activity. The reasons and influences of mobile device use described by mothers were similar to that of television viewing. However, the portability of mobile devices meant that they were often used outside of the home as a distraction tool. Their multi-functionality meant that they could be used as a portable television, or for purposeful learning through educational games and applications. Some mothers showed concerns over mobile device use by their child, whilst others felt it was an important and useful educational tool. Although the majority of mothers felt they needed to set rules and restrictions for mobile device use, many mothers felt that they are also a necessary and unavoidable part of life. CONCLUSIONS: Mothers in this study suggested that mobile device use by preschool children is common. More research is needed to determine the impact of mobile device use in preschool children, how much time preschool children spend using mobile devices and which activities their use may be replacing.

Understanding non-recreational prescription medication-sharing behaviours: a systematic review.

BACKGROUND: Prescription medication sharing refers to the lending or borrowing of prescription medications where the recipient is someone other than the person for whom the prescription is intended. Sharing prescription medication can cause significant harm. Adverse consequences include an increased risk of side effects, delayed health seeking, and severity of disease. Prevalence estimates vary across different populations and people's reasons for, and perceptions of risks from, sharing are poorly understood. AIM: To better understand prescription medication-sharing behaviours and practices - specifically, the prevalence, types of medications, reasons, perceived benefits and risks, and factors associated with medication sharing. DESIGN AND SETTING: This systematic review included primary studies in any setting, focusing on people who engage in medication sharing. METHOD: Electronic databases were searched from inception of databases to February 2023. RESULTS: In total, 19 studies were included. Prevalence of lifetime sharing ranged from 13% to 78%. All 19 studies reported that analgesics were the most shared, followed by antibiotics (n = 12) and allergy medication (n = 9). Common reasons for sharing were running out of medication (n = 7), cost (n = 7), and emergency (n = 6). Perceived benefits included resolution of the problem and convenience. Perceived risks included adverse drug reactions and misdiagnosis. Characteristics associated with sharing included age, female sex, having asthma, and unused medicines stored at home. CONCLUSION: Findings suggest that medication-sharing behaviour is common and involves a range of medicines for a variety of reasons. Data on the prevalence and predictors of prescription medication sharing are inconsistent. A better understanding of non-modifiable and potentially modifiable behavioural factors that contribute to sharing is needed to support development of effective interventions aimed at mitigating unsafe sharing practices.

Defining usual care comparators when designing pragmatic trials of complex health interventions: a methodology review.

BACKGROUND: Pragmatic trials evaluating complex health interventions often compare them to usual care. This comparator should resemble care as provided in everyday practice. However, usual care can differ for the same condition, between patients and practitioners, across clinical sites and over time. Heterogeneity within a usual care arm can raise methodological and ethical issues. To address these it may be necessary to standardise what usual care entails, although doing so may compromise a trial's external validity. Currently, there is no guidance detailing how researchers should decide the content of their usual care comparators. We conducted a methodology review to summarise current thinking about what should inform this decision. METHODS: MEDLINE, Embase, CINAHL and PsycINFO were searched from inception to January 2022. Articles and book chapters that discussed how to identify or develop usual care comparators were included. Experts in the field were also contacted. Reference lists and forward citation searches of included articles were screened. Data were analysed using a narrative synthesis approach. RESULTS: One thousand nine hundred thirty records were identified, 1611 titles and abstracts screened, 112 full texts screened, and 16 articles included in the review. Results indicated that the content of a usual care comparator should be informed by the aims of the trial, existing care practices, clinical guidelines, and characteristics of the target population. Its content should also be driven by the trial's requirements to protect participants, inform practice, and be methodologically robust, efficient, feasible and acceptable to stakeholders. When deciding the content of usual care, researchers will need to gather information about these drivers, balance tensions that might occur when responding to different trial objectives, and decide how usual care will be described and monitored in the trial. DISCUSSION: When deciding the content of a usual care arm, researchers need to understand the context in which a trial will be implemented and what the trial needs to achieve to address its aim and remain ethical. This is a complex decision-making process and trade-offs might need to be made. It also requires research and engagement with stakeholders, and therefore time and funding during the trial's design phase. TRIAL REGISTRATION: PROSPERO CRD42022307324.

Feasibility trial evaluation of a physical activity and screen-viewing course for parents of 6 to 8 year-old children: Teamplay.

BACKGROUND: Many children spend too much time screen-viewing (watching TV, surfing the internet and playing video games) and do not meet physical activity (PA) guidelines. Parents are important influences on children's PA and screen-viewing (SV). There is a shortage of parent-focused interventions to change children's PA and SV. METHODS: Teamplay was a two arm individualized randomized controlled feasibility trial. Participants were parents of 6-8 year old children. Intervention participants were invited to attend an eight week parenting program with each session lasting 2 hours. Children and parents wore an accelerometer for seven days and minutes of moderate-to-vigorous intensity PA (MVPA) were derived. Parents were also asked to report the average number of hours per day that both they and the target child spent watching TV. Measures were assessed at baseline (time 0) at the end of the intervention (week 8) and 2 months after the intervention had ended (week 16). RESULTS: There were 75 participants who provided consent and were randomized but 27 participants withdrew post-randomization. Children in the intervention group engaged in 2.6 fewer minutes of weekday MVPA at Time 1 but engaged in 11 more minutes of weekend MVPA. At Time 1 the intervention parents engaged in 9 more minutes of weekday MVPA and 13 more minutes of weekend MVPA. The proportion of children in the intervention group watching ≥ 2 hours per day of TV on weekend days decreased after the intervention (time 0 = 76%, time 1 = 39%, time 2 = 50%), while the control group proportion increased slightly (79%, 86% and 87%). Parental weekday TV watching decreased in both groups. In post-study interviews many mothers reported problems associated with wearing the accelerometers. In terms of a future full-scale trial, a sample of between 80 and 340 families would be needed to detect a mean difference of 10-minutes of weekend MVPA. CONCLUSIONS: Teamplay is a promising parenting program in an under-researched area. The intervention was acceptable to parents, and all elements of the study protocol were successfully completed. Simple changes to the trial protocol could result in more complete data collection and study engagement.

Process evaluation of the Teamplay parenting intervention pilot: implications for recruitment, retention and course refinement.

BACKGROUND: Parenting programs could provide effective routes to increasing children's physical activity and reducing screen-viewing. Many studies have reported difficulties in recruiting and retaining families in group parenting interventions. This paper uses qualitative data from the Teamplay feasibility trial to examine parents' views on recruitment, attendance and course refinement. METHODS: Semi-structured interviews were conducted with 16 intervention and 10 control group parents of 6-8 year old children. Topics discussed with the intervention group included parents' views on the recruitment, structure, content and delivery of the course. Topics discussed with the control group included recruitment and randomization. Interviews were digitally recorded, transcribed and thematically analyzed. RESULTS: Many parents in both the intervention and control group reported that they joined the study because they had been thinking about ways to improve their parenting skills, getting ideas on how to change behavior, or had been actively looking for a parenting course but with little success in enrolling on one. Both intervention and control group parents reported that the initial promotional materials and indicative course topics resonated with their experiences and represented a possible solution to parenting challenges. Participants reported that the course leaders played an important role in helping them to feel comfortable during the first session, engaging anxious parents and putting parents at ease. The most commonly reported reason for parents returning to the course after an absence was because they wanted to learn new information. The majority of parents reported that they formed good relationships with the other parents in the group. An empathetic interaction style in which leaders accommodated parent's busy lives appeared to impact positively on course attendance. CONCLUSIONS: The data presented indicate that a face-to-face recruitment campaign which built trust and emphasized how the program was relevant to families positively affected recruitment in Teamplay. Parents found the parenting component of the intervention attractive and, once recruited, attendance was facilitated by enjoyable sessions, empathetic leaders and support from fellow participants. Overall, data suggest that the Teamplay recruitment and retention approaches were successful and with small refinements could be effectively used in a larger trial.

Co-designing a nature-based intervention to promote postnatal mental health for mothers and their infants: a complex intervention development study in England.

OBJECTIVES: There is burgeoning evidence for the potential of nature-based interventions to improve wellbeing. However, the role of nature in enhancing maternal mental health, child development and early relationships remains relatively unexplored. This study aimed to develop a co-designed nature-based intervention to improve postnatal mothers' and infants' wellbeing. DESIGN, SETTING AND PARTICIPANTS: Person-based and co-design approaches informed the planning and design of the postnatal nature-based intervention. In stage 1, a multidisciplinary team was formed to agree research questions and appropriate methodology, and a scoping review was conducted. Six qualitative focus groups were then held with 30 mothers and 15 professional stakeholders. In stage 2, intervention guiding principles and a logic model were developed, and a stakeholder consensus meeting was convened to finalise the prototype intervention. The research was conducted in Bristol, UK, across voluntary, educational and community-based healthcare settings. RESULTS: Stakeholder consultation indicated significant enthusiasm for a postnatal nature-based intervention. A scoping review identified little existing research in this area. Focus group data are reported according to four broad themes: (1) perceived benefits of a group postnatal nature-based intervention, (2) potential drawbacks and barriers to access, (3) supporting attendance and implementation, and (4) ideas for intervention content. The developed intervention was tailored for mothers experiencing, or at risk of, postnatal mental health difficulties. It was identified that the intervention should facilitate engagement with the natural world through the senses, while taking into account a broad range of postnatal-specific practical and psychological needs. CONCLUSIONS: To our knowledge, this is the first reported use of person-based and co-design approaches to develop a postnatal nature-based intervention. The resulting intervention was perceived by target users to address their needs and preferences. Further research is needed to determine the feasibility, clinical and cost-effectiveness of this approach.

The effectiveness of exercise as a treatment for postnatal depression: study protocol.

BACKGROUND: Postnatal depression can have a substantial impact on the woman, the child and family as a whole. Thus, there is a need to examine different ways of helping women experiencing postnatal depression; encouraging them to exercise may be one way. A meta analysis found some support for exercise as an adjunctive treatment for postnatal depression but the methodological inadequacy of the few small studies included means that it is uncertain whether exercise reduces symptoms of postnatal depression. We aim to determine whether a pragmatic exercise intervention that involves one-to-one personalised exercise consultations and telephone support plus usual care in women with postnatal depression, is superior to usual care only, in reducing symptoms of postnatal depression. METHODS: We aim to recruit 208 women with postnatal depression in the West Midlands. Recently delivered women who meet the ICD-10 diagnosis for depression will be randomised to usual care plus exercise or usual care only. The exercise intervention will be delivered over 6 months. The primary outcome measure is difference in mean Edinburgh Postnatal Depression Scale score between the groups at six month follow-up. Outcome measures will be assessed at baseline and at six and 12 month post randomisation. DISCUSSION: Findings from the research will inform future clinical guidance on antenatal and postnatal mental health, as well as inform practitioners working with postnatal depression. TRIAL REGISTRATION NUMBER: ISRCTN84245563.

Parents' views and experiences of childhood obesity management in primary care: a qualitative study.

BACKGROUND: Primary care has been viewed as an appropriate setting for childhood obesity management. Little is known about parents' views and experiences of obesity management within this clinical setting. These views and experiences need to be explored, as they could affect treatment success. OBJECTIVE: To explore parents' views and experiences of primary care as a treatment setting for childhood obesity. METHODS: In-depth interviews were held with 15 parents of obese children aged 5-10 years, to explore their views and experiences of primary care childhood obesity management. Parents were contacted via a hospital-based childhood obesity clinic, general practices and Mind, Exercise, Nutrition … Do it! (MEND) groups based in Bristol, England. The interviews were audio-taped transcribed verbatim and analysed thematically. RESULTS: Parents viewed primary care as an appropriate setting in which to treat childhood obesity but were reluctant to consult due to a fear of being blamed for their child's weight and a concern about their child's mental well-being. They also questioned whether practitioners had the knowledge, time and resources to effectively manage childhood obesity. Parents varied in the extent to which they had found consulting a practitioner helpful, and their accounts suggested that GPs and school nurses offer different types of support. CONCLUSIONS: Parents need to be reassured that practitioners will address their child's weight in a non-judgemental sensitive manner and are able to treat childhood obesity effectively. A multidisciplinary team approach might benefit a child, as different practitioners may vary in the type of care they provide.

Designing a physical activity parenting course: parental views on recruitment, content and delivery.

BACKGROUND: Many children do not engage in sufficient levels of physical activity (PA) and spend too much time screen-viewing (SV). High levels of SV (e.g. watching TV, playing video games and surfing the internet) and low levels of PA have been associated with adverse health outcomes. Parenting courses may hold promise as an intervention medium to change children's PA and SV. The current study was formative work conducted to design a new parenting programme to increase children's PA and reduce their SV. Specifically, we focussed on interest in a course, desired content and delivery style, barriers and facilitators to participation and opinions on control group provision. METHODS: In-depth telephone interviews were conducted with thirty two parents (29 female) of 6-8 year olds. Data were analysed thematically. An anonymous online survey was also completed by 750 parents of 6-8 year old children and descriptive statistics calculated. RESULTS: Interview participants were interested in a parenting course because they wanted general parenting advice and ideas to help their children be physically active. Parents indicated that they would benefit from knowing how to quantify their child's PA and SV levels. Parents wanted practical ideas of alternatives to SV. Most parents would be unable to attend unless childcare was provided. Schools were perceived to be a trusted source of information about parenting courses and the optimal recruitment location. In terms of delivery style, the majority of parents stated they would prefer a group-based approach that provided opportunities for peer learning and support with professional input. Survey participants reported the timing of classes and the provision of childcare were essential factors that would affect participation. In terms of designing an intervention, the most preferred control group option was the opportunity to attend the same course at a later date. CONCLUSIONS: Parents are interested in PA/SV parenting courses but the provision of child care is essential for attendance. Recruitment is likely to be facilitated via trusted sources. Parents want practical advice on how to overcome barriers and suggest advice is provided in a mutually supportive group experience with expert input.

Parents' views on child physical activity and their implications for physical activity parenting interventions: a qualitative study.

BACKGROUND: Establishing healthy physical activity (PA) behaviours in early childhood is important for future PA behaviours. Parents play a central role in young children's PA. However, there is currently little research on parenting interventions to increase child PA. This study was formative work to inform the content of a pilot randomised-controlled trial. METHODS: In-depth telephone interviews were carried out with 32 parents of 6 to 8 year old children residing in two areas that varied in their socio-economic characteristics, in Bristol, UK. Data were analysed thematically using a framework approach. RESULTS: Most parents described their child as being active or very active and indicated that they did not perceive a need for an increase in their child's PA. Parents used a variety of visual cues to make this judgement, the most common being that they perceived their child as having lots of energy or that they did not view them as overweight. Parents reported environmental factors such as monetary cost, time constraints, lack of activity provision and poor weather as the main barriers to their child's PA. Parental support and child's enjoyment of PA appeared to be important facilitators to children participating in PA. CONCLUSION: Improving parents' knowledge of the PA recommendations for children, and increasing their awareness of the benefits of PA beyond weight status may be an important first step for a parenting PA intervention. Although parents commonly perceive environmental factors as the main barriers to their child's PA, parental concern about low levels of child PA, their capacity to support behaviour change, child motivation, self confidence and independence may be key areas to address within an intervention to increase child PA. Effective methods of helping parents address the latter have been developed in the context of generic parenting programmes.

Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP): Protocol for a multicentre cluster randomised trial comparing a complex intervention for medication optimization against usual care.

Introduction: Polypharmacy is increasingly common, and associated with undesirable consequences. Polypharmacy management necessitates balancing therapeutic benefits and risks, and varying clinical and patient priorities. Current guidance for managing polypharmacy is not supported by high quality evidence. The aim of the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) trial is to evaluate the effectiveness of an intervention to optimise medication use for patients with polypharmacy in a general practice setting. Methods: This trial will use a multicentre, open-label, cluster-randomised controlled approach, with two parallel groups. Practices will be randomised to a complex intervention comprising structured medication review (including interprofessional GP/pharmacist treatment planning and patient-facing review) supported by performance feedback, financial incentivisation, clinician training and clinical informatics (intervention), or usual care (control). Patients with polypharmacy and triggering potentially inappropriate prescribing (PIP) indicators will be recruited in each practice using a computerised search of health records. 37 practices will recruit 50 patients, and review them over a 26-week intervention delivery period. The primary outcome is the mean number of PIP indicators triggered per patient at 26 weeks follow-up, determined objectively from coded GP electronic health records. Secondary outcomes will include patient reported outcome measures, and health and care service use. The main intention-to-treat analysis will use linear mixed effects regression to compare number of PIP indicators triggered at 26 weeks post-review between groups, adjusted for baseline (pre-randomisation) values. A nested process evaluation will explore implementation of the intervention in primary care. Ethics and dissemination: The protocol and associated study materials have been approved by the Wales REC 6, NHS Research Ethics Committee (REC reference 19/WA/0090), host institution and Health Research Authority. Research outputs will be published in peer-reviewed journals and relevant conferences, and additionally disseminated to patients and the public, clinicians, commissioners and policy makers. ISRCTN Registration: 90146150 (28/03/2019).

General practitioners' views and experiences in caring for patients after sepsis: a qualitative interview study.

BACKGROUND: Patients surviving critical illnesses, such as sepsis, often suffer from long-term complications. After discharge from hospital, most patients are treated in primary care. Little is known how general practitioners (GPs) perform critical illness aftercare and how it can be improved. Within a randomised controlled trial, an outreach training programme has been developed and applied. OBJECTIVES: The aim of this study is to describe GPs' views and experiences of caring for postsepsis patients and of participating a specific outreach training. DESIGN: Semistructured qualitative interviews. SETTING: 14 primary care practices in the metropolitan area of Berlin, Germany. PARTICIPANTS: 14 GPs who had participated in a structured sepsis aftercare programme in primary care. RESULTS: Themes identified in sepsis aftercare were: continuity of care and good relationship with patients, GP's experiences during their patient's critical illness and impact of persisting symptoms. An outreach education as part of the intervention was considered by the GPs to be acceptable, helpful to improve knowledge of the management of postintensive care complications and useful for sepsis aftercare in daily practice. CONCLUSIONS: GPs provide continuity of care to patients surviving sepsis. Better communication at the intensive care unit-GP interface and training in management of long-term complications of sepsis may be helpful to improve sepsis aftercare. TRIAL REGISTRATION NUMBER: ISRCTN61744782.

Trauma-informed approaches to primary and community mental health care: protocol for a mixed-methods systematic review.

INTRODUCTION: Exposure to different types of psychological trauma may lead to a range of adverse effects on trauma survivors, including poor mental and physical health, economic, social and cognitive functioning outcomes. Trauma-informed (TI) approaches to care are defined as a service system grounded in and directed by an understanding of how trauma affects the survivors' neurological, biological, physiological and social development. TI service system involves training of all staff, service improvements and sometimes screening for trauma experiences. The UK started incorporating TI approaches into the National Health Service. While policies recommend it, the evidence base for TI approaches to healthcare is not well established. We aim to conduct a systematic review to synthesise evidence on TI approaches in primary and community mental healthcare globally. METHODS AND ANALYSIS: We will undertake a systematic search for primary studies in Medline, Embase, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Cochrane library, websites of organisations involved in the development and implementation of TI approaches in healthcare, and databases of thesis and dissertation. Included studies will be in English published between 1990 and February 2020. Two reviewers will independently perform study selection with data extraction and quality appraisal undertaken by one reviewer and checked for accuracy by a second reviewer. A results-based convergent synthesis will be conducted where quantitative (narratively) and qualitative (thematically) evidence will be analysed separately and then integrated using another method of synthesis. We set up a trauma survivor group and a professional group to consult throughout this review. ETHICS AND DISSEMINATION: There is no requirement for ethical approval for this systematic review as no empirical data will be collected. The findings will be disseminated through a peer-reviewed publication, scientific and practitioner conferences, and policy briefings targeted at local and national policy makers. PROSPERO REGISTRATION NUMBER: CRD42020164752.

Feasibility study of eye movement desensitisation and reprocessing (EMDR) in people with an at-risk mental state (ARMS) for psychosis: study protocol.

INTRODUCTION: Trauma can play an important role in the development of psychosis, yet no studies have investigated whether a trauma-focused psychological therapy could prevent the onset of psychosis in people at high risk of developing this condition. This study aims to establish whether it would be feasible to conduct a multicentre randomised controlled trial (RCT) to investigate the clinical and cost-effectiveness of eye movement desensitisation and reprocessing (EMDR) therapy to prevent the onset of psychosis in people with an at-risk mental state (ARMS). METHODS/ANALYSIS: This is a single-arm trial with a nested qualitative study where all participants (target n=20) will be offered EMDR. Eligible participants are those who meet criteria for ARMS; have experienced a traumatic event before the onset of ARMS symptomatology; and have at least one symptom of post-traumatic stress disorder (PTSD). Participants will be followed up at 4, 8 and 12 months after the baseline assessment. The primary outcome measure is transition to psychosis, and secondary outcome measures include severity of psychotic symptoms, PTSD, depression, anxiety, impaired functioning, health status and resource use. The analysis will aim to establish the rates of recruitment and retention for a large-scale RCT. Interviews with therapists and patients will explore their views of the study and their experiences of delivering or receiving EMDR. ETHICS AND DISSEMINATION: This protocol has been approved by the South West-Cornwall and Plymouth Research Ethics Committee (Reference 18/SW/0037). Findings will be disseminated through journal publications, conference presentations and meetings with service users, their families, mental health professionals and commissioners. TRIAL REGISTRATION NUMBER: ISRCTN31976295.

Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study.

OBJECTIVE: To improve the quality and consistency of intervention development reporting in health research. DESIGN: This was a consensus exercise consisting of two simultaneous and identical three-round e-Delphi studies (one with experts in intervention development and one with wider stakeholders including funders, journal editors and public involvement members), followed by a consensus workshop. Delphi items were systematically derived from two preceding systematic reviews and a qualitative interview study. PARTICIPANTS: Intervention developers (n=26) and wider stakeholders (n=18) from the UK, North America and Europe participated in separate e-Delphi studies. Intervention developers (n=13) and wider stakeholders (n=13) participated in a 1-day consensus workshop. RESULTS: e-Delphi participants achieved consensus on 15 reporting items. Following feedback from the consensus meeting, the final inclusion and wording of 14 items with description and explanations for each item were agreed. Items focus on context, purpose, target population, approaches, evidence, theory, guiding principles, stakeholder contribution, changes in content or format during the development process, required changes for subgroups, continuing uncertainties, and open access publication. They form the GUIDED (GUIDance for the rEporting of intervention Development) checklist, which contains a description and explanation of each item, alongside examples of good reporting. CONCLUSIONS: Consensus-based reporting guidance for intervention development in health research is now available for publishers and researchers to use. GUIDED has the potential to lead to greater transparency, and enhance quality and improve learning about intervention development research and practice.

Patients with Type 2 Diabetes experiences of making multiple lifestyle changes: a qualitative study.

OBJECTIVES: To explore patients newly diagnosed with Type 2 Diabetes Mellitus (T2DM) experiences of making single (diet) or multiple (diet and physical activity) changes in order to (1) assess whether patients experienced increases in physical activity as supporting or hindering dietary changes and vice versa, and (2) whether patients found making multiple lifestyle changes counterproductive or beneficial. METHODS: In-depth interviews with 30 individuals taking part in a randomised controlled trial that aimed to determine the effect of diet and physical activity on T2DM. Interviewees had been randomised to receive usual care, intensive dietary advice, or intensive dietary advice plus information on physical activity. Respondents were interviewed 6 and 9 months post-randomisation. They were asked about their experiences of making lifestyle changes. Data were analysed thematically. RESULTS: Findings suggest providing diet and physical activity information together encourages patients to use physical activity in strategic ways to aid disease management and that most patients find undertaking multiple lifestyle changes helpful. CONCLUSION: Increasing physical activity can act as a gateway behaviour, i.e. behaviour that produces positive effects in other behaviours. PRACTICE IMPLICATIONS: Practitioners should provide diet and physical activity information together to encourage patients to use physical activity strategically to maintain dietary changes.