Eye-movement desensitisation and reprocessing therapy (EMDR) to prevent transition to psychosis in people with an at-risk mental state (ARMS): mixed method feasibility study.

BACKGROUND: Trauma plays an important role in the development of psychosis, but no studies have investigated whether a trauma-focused therapy could prevent psychosis. AIMS: This study aimed to establish whether it would be feasible to conduct a multicentre randomised controlled trial (RCT) to prevent psychosis in people with an at-risk mental state (ARMS), using eye-movement desensitisation and reprocessing therapy (EMDR). METHOD: This started as a mixed-method randomised study comparing EMDR to treatment as usual but, as a result of low participant recruitment, was changed to a single-arm feasibility study. The proposed primary outcome for an RCT was transition to psychosis at 12-month follow-up. Data on secondary outcomes were also collected. Qualitative interviews were conducted with patients and therapists. RESULTS: Fourteen participants were recruited from the Early Intervention teams. Most people who expressed an interest in taking part attended an assessment to determine eligibility. All those eligible consented to take part. A total of 64% (7 of 11) of participants who were offered EMDR were followed up at 12 months. Of the 11 participants offered EMDR, one (11%, 95% CI: 0.2%, 48%) transitioned to psychosis. Nine patients and three therapists were interviewed. Participants who completed therapy (n = 4; mean 10.5 sessions) found EMDR helpful, but those who discontinued (n = 6; mean 5.2 sessions) said it had not benefitted them overall. Therapists said EMDR could be effective, although not for all patients. CONCLUSIONS: Future studies recruiting people with an ARMS to an RCT may need to extend recruitment beyond Early Intervention teams. Although some individuals found EMDR helpful, reasons for discontinuing need to be addressed in future studies.

Text Messages With Financial Incentives for Men With Obesity: A Randomized Clinical Trial.

Importance: Effective weight loss interventions are needed for men with obesity. Objective: To determine whether an intervention that combined text messaging with financial incentives attained significant weight loss at the 12-month follow-up compared with the control group and whether an intervention of text messaging alone attained significant weight loss at the 12-month follow-up compared with the control group. Design, Setting, and Participants: An assessor-blinded randomized clinical trial conducted in Belfast, Bristol, and Glasgow areas in the UK. A total of 585 men with body mass index (BMI) of 30 or more were enrolled between July 2021 and May 2022. Final follow-up occurred June 2023. Interventions: Participants were randomly assigned to 12 months of behavioral focused text messages combined with financial incentives (n = 196), 12 months of behavioral focused text messages alone (n= 194), or a waiting list (control group; n= 195). The financial incentive consisted of a monetary reward that was lost if weight loss targets were not met. All participants received weight management information and a pedometer at baseline. Main Outcomes and Measures: The 2 primary comparisons were the 12-month comparison of within-participant weight change between the text messaging with financial incentive group and the control group and the comparison between the text messaging alone group and the control group (minimum clinically important difference, 3%). The P value defined for statistical significance was P < .025 for each comparison. Results: Of the 585 men (mean [SD] age, 50.7 [13.3] years; mean weight, 118.5 [19.9] kg; mean BMI, 37.7 [5.7]; 525 [90%] White), 227 (39%) lived in postal code areas with lower socioeconomic status, and 426 (73%) completed the 12-month follow-up. At the 12-month follow-up, compared with the control group, the mean percent weight change was significantly greater in the text messaging with financial incentive group (mean difference, -3.2%; 97.5% CI, -4.6% to -1.9%; P < .001) but was not significantly greater in the text messaging alone group (mean difference, -1.4%; 97.5% CI, -2.9% to 0.0, P = .05). The mean (SD) weight changes were -5.7 (7.4) kg for the text messaging with financial incentives group, -3.0 (7.5) kg for the text messaging alone group, and -1.5 (6.6) kg for the control group. The 12-month mean (SD) percentage weight changes from baseline were -4.8% (6.1%) for the text messaging with financial incentives group, -2.7% (6.3%) for text messaging alone group, and -1.3% (5.5%) for the control group. Of 366 adverse events reported, the most common were infections (83 [23%]). Of the 23 serious adverse events (6.3%), 12 (52%) occurred in the text messaging with financial incentives group, 5 (22%) in the texts messaging alone group, and 6 (26%) in the control group. None were considered related to participating in a trial group. Conclusion and Relevance: Among men with obesity, an intervention with text messaging with financial incentive significantly improved weight loss compared with a control group, whereas text messaging alone was not significantly better than the control condition. These findings support text messaging combined with financial incentives to attain weight loss in men with obesity. Trial Registration: isrctn.org Identifier: ISRCTN91974895.

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.

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.

Provision of online eye movement and desensitisation therapy (EMDR) for people with post-traumatic stress disorder (PTSD): a multi-method service evaluation.

Background: The evidence for the effectiveness of online EMDR for PTSD is scarce.Objective: This service evaluation aimed to assess how online EMDR compared to in-person EMDR, in terms of its potential effectiveness and acceptability to therapists and patients.Method: The evaluation was carried out in the Cardiff and Vale University Health Board Traumatic Stress Service. We compared the outcome of therapy (PTSD scores at end of treatment), number of sessions, drop-out rate, and adverse events using linear/logistic regression in those receiving online EMDR over a 12-month period with those who had received in-person therapy in the year previous to that. Interviews with therapists and clients who had provided or undertaken online EMDR explored their views and experiences of treatment. Interviews were analysed thematically.Results: 33 people received in-person EMDR (15.3 sessions, SD = 1.4), and 45 received online EMDR (12.4 sessions, SD = 0.9). 24 individuals completed therapy in-person, and 32 online. There was no evidence of a difference in therapy completion, drop-out rates or adverse events between the two delivery modes. There was weak evidence that those who completed EMDR online and had available data (N = 29), had slightly lower PTSD scores at the end of therapy compared to those who received in-person EMDR (N = 24) (17.1 (SD = 3.2) versus 24.5 (SD = 3.0), mean difference = 7.8, 95% CI -0.3, 15.9, p = .06). However, groups were not randomised and only those who completed treatment were analysed, so estimates may be biased. 11 patients and five therapists were interviewed. Overall, both therapists and clients viewed online EMDR as safe and effective. Benefits mentioned by clients included feeling more in control and not having to travel. Clients' concerns related to lack of privacy and 'transition time/space' between therapy and their daily lives.Conclusion: Results suggest that online EMDR is an acceptable, safe and effective alternative to in-person EMDR for PTSD in this service.

This service evaluation assessed how online Eye Movement Desensitisation and Reprocessing (EMDR) compared to in-person EMDR in people with PTSD.Individuals receiving online EMDR had lower PTSD scores at the end of therapy, but the evidence for this was weak and as this was not a randomised trial we do not know whether this was due to the mode of therapy or other characteristics of clients receiving online therapy.Clients and therapists generally viewed online EMDR as being safe and effective, and supported the availability of online EMDR for PTSD.

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.

Non-randomised feasibility study of training workshops for Talking Therapies service high-intensity therapists to optimise depression and anxiety outcomes for individuals with co-morbid personality difficulties: a study protocol.

BACKGROUND: The NHS Talking Therapies for Anxiety and Depression programme ('TTad'; formerly Improving Access to Psychological Therapies 'IAPT') delivers high-intensity cognitive behavioural therapy (CBT) to over 200,000 individuals each year for common mental health problems like depression and anxiety. More than half of these individuals experience comorbid personality difficulties, who show poorer treatment outcomes. TTad therapists report feeling unskilled to work with clients with personality difficulties, and enhancing the training of TTad therapists may lead to improved treatment outcomes for individuals presenting with secondary personality difficulties alongside depression and anxiety. METHODS: This is a pre-post non-randomised mixed-method feasibility study, exploring the feasibility and acceptability of a 1-day training workshop for high-intensity (HI) CBT therapists. The workshop is focused on understanding and assessing personality difficulties and adapting HICBT treatments for anxiety and depression to accommodate client needs. The feasibility and acceptability of the workshop and the evaluation procedures will be investigated. It will be examined to what extent the workshop provision leads to improvements in therapist skills and confidence and explored to what extent the training has the potential to enhance clinical outcomes for this client group. DISCUSSION: This feasibility study will provide data on the acceptability and feasibility of delivering brief therapist training to adapt usual HICBT to optimise care for individuals with secondary personality difficulties seeking treatment in TTad services for a primary problem of depression and/or anxiety. The study will also evaluate proof of concept that such an approach has the potential to improve clinical outcomes for those with secondary personality difficulties and report any possible harms identified. The study will inform the design of a future randomised controlled trial designed to test the effectiveness and cost-effectiveness of the training. TRIAL REGISTRATION: ISRCTN81104604 . Submitted on 6th June 2022. Registration date: 3rd January 2023.

Integrated therapist and online CBT for depression in primary care (INTERACT): study protocol for a multi-centre randomised controlled trial.

BACKGROUND: Cognitive behavioural therapy (CBT) is an effective treatment for depression. Self-directed online CBT interventions have made CBT more accessible at a lower cost. However, adherence is often poor and, in the absence of therapist support, effects are modest and short-term. Delivering CBT online using instant messaging is clinically and cost-effective; however, most existing platforms are limited to instant messaging sessions, without the support of between-session "homework" activities. The INTERACT intervention integrates online CBT materials and 'high-intensity' therapist-led CBT, delivered remotely in real-time. The INTERACT trial will evaluate this novel integration in terms of clinical and cost-effectiveness, and acceptability to therapists and clients. METHODS: Pragmatic, two parallel-group multi-centre individually randomised controlled trial, with 434 patients recruited from primary care practices in Bristol, London and York. Participants with depression will be identified via General Practitioner record searches and direct referrals. INCLUSION CRITERIA: aged ≥ 18 years; score ≥ 14 on Beck Depression Inventory (BDI-II); meeting International Classification of Diseases (ICD-10) criteria for depression. EXCLUSION CRITERIA: alcohol or substance dependency in the past year; bipolar disorder; schizophrenia; psychosis; dementia; currently under psychiatric care for depression (including those referred but not yet seen); cannot complete questionnaires unaided or requires an interpreter; currently receiving CBT/other psychotherapy; received high-intensity CBT in the past four years; participating in another intervention trial; unwilling/unable to receive CBT via computer/laptop/smartphone. Eligible participants will be randomised to integrated CBT or usual care. Integrated CBT utilises the standard Beckian intervention for depression and comprises nine live therapist-led sessions, with (up to) a further three if clinically appropriate. The first session is 60-90 min via videocall, with subsequent 50-min sessions delivered online, using instant messaging. Participants allocated integrated CBT can access integrated online CBT resources (worksheets/information sheets/videos) within and between sessions. Outcome assessments at 3-, 6-, 9- and 12-month post-randomisation. The primary outcome is the Beck Depression Inventory (BDI-II) score at 6 months (as a continuous variable). A nested qualitative study and health economic evaluation will be conducted. DISCUSSION: If clinically and cost-effective, this model of integrated CBT could be introduced into existing psychological services, increasing access to, and equity of, CBT provision. TRIAL REGISTRATION: ISRCTN, ISRCTN13112900. Registered on 11/11/2020. Currently recruiting participants. Trial registration data are presented in Table 1.

Non-pharmacological interventions for the management of perinatal anxiety in primary care: a meta-review of systematic reviews.

BACKGROUND: Perinatal anxiety (PNA), anxiety that occurs during pregnancy and/or up to 12 months postpartum, is estimated to affect up to 21% of women, and may impact negatively on mothers, children, and their families. The National Institute for Health and Care Excellence (NICE) has called for further research around non-pharmacological interventions in primary care for PNA. AIM: To summarise the available international evidence on non-pharmacological interventions for women with PNA in a primary care population. DESIGN & SETTING: A meta-review of systematic reviews (SRs) with narrative synthesis was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance. METHOD: Systematic literature searches were conducted in 11 health-related databases up to June 2022. Titles, abstracts, and full-text articles were dual-screened against pre-defined eligibility criteria. A variety of study designs were included. Data were extracted about study participants, intervention design, and context. Quality appraisal was performed using the AMSTAR 2 tool (A MeaSurement Tool to Assess systematic Reviews). A patient and public involvement group informed and contributed towards this meta-review. RESULTS: Twenty-four SRs were included in the meta-review. Interventions were grouped into the following six categories for analysis purposes: psychological therapies; mind-body activities; emotional support from healthcare professionals (HCPs); peer support; educational activities; and alternative or complementary therapies. CONCLUSION: In addition to pharmacological and psychological therapies, this meta-review has demonstrated that there are many more options available for women to choose from that might be effective to manage their PNA. Evidence gaps are present in several intervention categories. Primary care clinicians and commissioners should endeavour to provide patients with a choice of these management options, promoting individual choice and patient-centred care.

The identification and management of people with an at-risk mental state (ARMS) for psychosis in primary and secondary care services: A qualitative interview study.

AIMS: Early intervention in people with an at-risk mental state (ARMS) for psychosis can prevent the onset of psychosis. Clinical guidelines recommend that ARMS are referred to triage services, and then to Early Intervention (EI) teams in secondary care for assessment and treatment. However, little is known about how ARMS patients are identified and managed in UK primary and secondary care. This study explored patients' and clinicians' views of ARMS patients' care pathways. METHODS: Eleven patients, 20 GPs, 11 clinicians from the triaging Primary Care Liaison Services (PCLS) and 10 EI clinicians were interviewed. Data were analysed thematically. RESULTS: Most patients said their symptoms started in adolescence with depression and anxiety. Before being referred to EI teams, most patients were referred by their GP to well-being services for talking therapies, which they had not found helpful. Some GPs said secondary care's high acceptance thresholds and scarce treatment availability made them reluctant to refer to EI teams. Triage in PCLS was influenced by patients' risk of self-harm, and formulation of psychotic symptoms; only those without clear evidence of other pathology and not at high risk of self-harm were referred to EI teams, the others being referred to Recovery/Crisis services. Although patients referred to EI teams were offered an assessment, only some EI teams were commissioned to treat ARMS. CONCLUSIONS: Individuals meeting ARMS criteria might not receive early intervention due to high treatment thresholds and limited treatment availability in secondary care, suggesting clinical guidelines are not being met for this patient group.

Mothers' accounts of the impact of being in nature on postnatal wellbeing: a focus group study.

BACKGROUND: The postnatal period is a vulnerable time for mothers to experience stress and mental health difficulties. There is increasing evidence that spending time in nature is beneficial for wellbeing. Nature-based interventions have been developed to support mental health, but not specifically tailored for mothers during the postnatal period. Understanding mothers' views and experiences of nature would help determine the suitability for and potential impact of such interventions on postnatal wellbeing. AIMS: To explore mothers' views on the impact of spending time in nature on their postnatal mental wellbeing. METHODS: Focus groups were held with mothers of young children (under five), including mothers from migrant and refugee communities, mothers living with mental health difficulties, and disabled mothers. Data were analysed using reflexive thematic analysis. RESULTS: Four focus groups were held, with a total of 30 participants. Six themes were developed: (1) mothers' experiences of what constitutes 'nature'; (2) sensing nature improves wellbeing; (3) natural spaces facilitate human connection; (4) nature provides escape and relief from daily indoor stressors; (5) nature allows new perspectives; and (6) mothers face a variety of environmental, practical, psychological, physical, socioeconomic, and cultural barriers to spending time in nature during the postnatal period. CONCLUSIONS: Mothers report significant benefits to their postnatal wellbeing when spending time in nature. Further research is warranted to understand whether nature-based interventions have the potential to support postnatal wellbeing, socially, mentally, and physically.

Effectiveness and cost-effectiveness of text messages with or without endowment incentives for weight management in men with obesity (Game of Stones): study protocol for a randomised controlled trial.

BACKGROUND: Obesity increases the risk of type 2 diabetes, heart disease, stroke, mobility problems and some cancers, and its prevalence is rising. Men engage less than women in existing weight loss interventions. Game of Stones builds on a successful feasibility study and aims to find out if automated text messages with or without endowment incentives are effective and cost-effective for weight loss at 12 months compared to a waiting list comparator arm in men with obesity. METHODS: A 3-arm, parallel group, assessor-blind superiority randomised controlled trial with process evaluation will recruit 585 adult men with body mass index of 30 kg/m2 or more living in and around three UK centres (Belfast, Bristol, Glasgow), purposively targeting disadvantaged areas. Intervention groups: (i) automated, theory-informed text messages daily for 12 months plus endowment incentives linked to verified weight loss targets at 3, 6 and 12 months; (ii) the same text messages and weight loss assessment protocol; (iii) comparator group: 12 month waiting list, then text messages for 3 months. The primary outcome is percentage weight change at 12 months from baseline. Secondary outcomes at 12 months are as follows: quality of life, wellbeing, mental health, weight stigma, behaviours, satisfaction and confidence. Follow-up includes weight at 24 months. A health economic evaluation will measure cost-effectiveness over the trial and over modelled lifetime: including health service resource-use and quality-adjusted life years. The cost-utility analysis will report incremental cost per quality-adjusted life years gained. Participant and service provider perspectives will be explored via telephone interviews, and exploratory mixed methods process evaluation analyses will focus on mental health, multiple long-term conditions, health inequalities and implementation strategies. DISCUSSION: The trial will report whether text messages (with and without cash incentives) can help men to lose weight over 1 year and maintain this for another year compared to a comparator group; the costs and benefits to the health service; and men's experiences of the interventions. Process analyses with public involvement and service commissioner input will ensure that this open-source digital self-care intervention could be sustainable and scalable by a range of NHS or public services. TRIAL REGISTRATION: ISRCTN 91974895 . Registered on 14/04/2021.

Rise in prescribing for anxiety in UK primary care between 2003 and 2018: a population-based cohort study using Clinical Practice Research Datalink.

BACKGROUND: Little is known about trends in prescribing of anxiolytics (antidepressants, benzodiazepines, beta-blockers, anticonvulsants, and antipsychotics) for treatment of anxiety. Several changes may have affected prescribing in recent years, including changes in clinical guidance. AIM: To examine trends in prescribing for anxiety in UK primary care between 2003 and 2018. DESIGN AND SETTING: A population-based cohort study using Clinical Practice Research Datalink (CPRD) data. METHOD: Analysis of data from adults (n = 2 569 153) registered at CPRD practices between 2003 and 2018. Prevalence and incidence rates were calculated for prescriptions of any anxiolytic and also for each drug class. Treatment duration was also examined. RESULTS: Between 2003 and 2018, prevalence of any anxiolytic prescription increased from 24.9/1000 person-years-at-risk (PYAR) to 43.6/1000 PYAR, driven by increases in those starting treatment, rather than more long-term use. Between 2003 and 2006, incidence of any anxiolytic prescription decreased from 12.8/1000 PYAR to 10.0/1000 PYAR; after which incidence rose to 13.1/1000 PYAR in 2018. Similar trends were seen for antidepressant prescriptions. Incident beta-blocker prescribing increased over the 16 years, whereas incident benzodiazepine prescriptions decreased. Long-term prescribing of benzodiazepines declined, yet 44% of prescriptions in 2017 were longer than the recommended 4 weeks. Incident prescriptions in each drug class have risen substantially in young adults in recent years. CONCLUSION: Recent increases in incident prescribing, especially in young adults, may reflect better detection of anxiety, increasing acceptability of medication, or an earlier unmet need. However, some prescribing is not based on robust evidence of effectiveness, may contradict guidelines, and there is limited evidence on the overall impact associated with taking antidepressants long term. As such, there may be unintended harm.

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).

The approach to managing perinatal anxiety: A mini-review.

Perinatal Anxiety (PNA) is defined as anxiety occurring during pregnancy and up to 12 months post-partum and is estimated to affect up to 20% of women. Risk factors for PNA are multiple and can be classed as psychological, social and biological. PNA negatively impacts on the mother, child and family. PNA is not well-recognized and diagnosis of PNA can be challenging for clinicians. There is currently no validated case-finding or diagnostic test available for PNA. PNA has been less extensively researched than perinatal depression (PND). Clinical guidance currently recommends pharmacological and psychological therapies for the management of women with PNA, however the limited research available suggests that other intervention types may also be effective with some evidence on the effectiveness of non-pharmacological interventions in primary care for PNA. This article provides a mini-review of PNA, summarizing current evidence around PNA including risk factors, the impact of PNA, the process of diagnosis of PNA and focussing predominantly on available management options for PNA.

PTSD as a mediator of the relationship between trauma and psychotic experiences.

BACKGROUND: Traumatic experiences are associated with a higher risk of psychotic illnesses, but little is known about potentially modifiable mechanisms underlying this relationship. This study aims to examine whether post-traumatic stress disorder (PTSD) symptoms mediate the relationship between trauma and psychotic experiences (PEs). METHODS: We used data from the Avon Longitudinal Study of Parents and Children to examine whether: PTSD symptoms mediate the relationships between (a) childhood trauma and adolescent PEs (study of adolescent PEs; n = 2952), and (b) childhood/adolescent trauma and PEs in early adulthood (study of adult PEs; n = 2492). We examined associations between variables using logistic regression, and mediation using the parametric g-computation formula. RESULTS: Exposure to trauma was associated with increased odds of PEs (adolescent PEs: ORadjusted 1.48, 95% CI 1.23-1.78; adult PEs: ORadjusted 1.57, 95% CI 1.25-1.98) and PTSD symptoms (adolescent PTSD: ORadjusted 1.59, 95% CI 1.31-1.93; adult PTSD: ORadjusted 1.50, 95% CI 1.36-1.65). The association between PTSD symptoms and PE was stronger in adolescence (ORadjusted 4.63, 95% CI 2.34-9.17) than in adulthood (ORadjusted 1.62, 95% CI 0.80-3.25). There was some evidence that PTSD symptoms mediated the relationship between childhood trauma and adolescent PEs (proportion mediated 14%), though evidence of mediation was weaker for adult PEs (proportion mediated 8%). CONCLUSIONS: These findings are consistent with the hypothesis that PTSD symptoms partly mediate the association between trauma exposure and PEs. Targeting PTSD symptoms might help prevent the onset of psychotic outcomes.

Trends in the recording of anxiety in UK primary care: a multi-method approach.

PURPOSE: Anxiety disorders are common. Between 1998 and 2008, in the UK, GP recording of anxiety symptoms increased, but the recording of anxiety disorders decreased. We do not know whether such trends have continued. This study examined recent trends in the recording of anxiety and explored factors that may influence GPs' coding of anxiety. METHODS: We used data from adults (n = 2,569,153) registered with UK general practices (n = 176) that contributed to the Clinical Practice Research Datalink between 2003 and 2018. Incidence rates and 95% confidence intervals were calculated for recorded anxiety symptoms and diagnoses and were stratified by age and gender. Joinpoint regression was used to estimate the years trends changed. In addition, in-depth interviews were conducted with 15 GPs to explore their views and management of anxiety. Interviews were audio-recorded, transcribed verbatim and analysed thematically. RESULTS: The incidence of anxiety symptoms rose from 6.2/1000 person-years at risk (PYAR) in 2003 to 14.7/1000 PYAR in 2018. Between 2003 and 2008, the incidence of anxiety diagnoses fell from 13.2 to 10.1/1000 PYAR; markedly increasing between 2013 and 2018 to 15.3/1000 PYAR. GPs mentioned that they preferred using symptom codes to diagnostic codes to avoid assigning potentially stigmatising or unhelpful labels, and commented on a rise in anxiety in recent years, especially in young adults. CONCLUSION: Recent increases in the recording of both anxiety diagnoses and symptoms may reflect increased presentation to primary care, especially in young adults. There is a clear need to understand the reasons for this, and this knowledge may be critical in the prevention and treatment of anxiety.

The NetSage measurement and analysis framework in practice.

Data sharing is required for research collaborations, but effective data transfer performance continues to be difficult to achieve. The NetSage Measurement and Analysis Framework can assist in understanding research data movement. It collects a broad set of monitoring data and builds performance Dashboards to visualize the data. Each Dashboard is specifically designed to address a well-defined analysis need of the stakeholders. This paper describes the design methodology, the resulting architecture, the development approach and lessons learned, and a set of discoveries that NetSage Dashboards made possible.

Shared decision making in consultations for hypertension: Qualitative study in general practice.

BACKGROUND: Hypertension is mainly managed in primary care. Shared decision making is widely recommended as an approach to treatment decision making. However, no studies have investigated; in detail, what happens during primary care consultations for hypertension. AIM: To understand patients' and clinicians' experience of shared decision making for hypertension in primary care, in order to propose how it might be better supported. DESIGN: Longitudinal qualitative study. SETTING: Five general practices in south-west England. METHOD: Interviews with a purposive sample of patients with hypertension, and with the health-care practitioners they consulted, along with observations of clinical consultations, for up to 6 appointments. Interviews and consultations were audio-recorded and observational field notes taken. Data were analysed thematically. RESULTS: Forty-six interviews and 18 consultations were observed, with 11 patients and nine health-care practitioners (five GPs, one pharmacist and three nurses). Little shared decision making was described by participants or observed. Often patients' understanding of their hypertension was limited, and they were not aware there were treatment choices. Consultations provided few opportunities for patients and clinicians to reach a shared understanding of their treatment choices. Opportunities for patients to engage in choices were limited by structured consultations and the distribution of decisions across consultations. CONCLUSION: For shared decision making to be better supported, consultations need to provide opportunities for patients to learn about their condition, to understand that there are treatment choices, and to discuss these choices with clinicians. PATIENT OR PUBLIC CONTRIBUTION: A patient group contributed to the design of this study.

GPs' and patients' views on the value of diagnosing anxiety disorders in primary care: a qualitative interview study.

BACKGROUND: In the UK between 1998 and 2008, GPs' recording of anxiety symptoms increased, but their recording of anxiety disorders decreased. The reason for this decline is not clear, nor are the treatment implications for primary care patients. AIM: To understand GPs' and patients' views on the value of diagnosing anxiety disorders in primary care. DESIGN AND SETTING: In-depth interviews were conducted with 15 GPs and 20 patients, purposively sampled from GP practices in Bristol and the surrounding areas. METHOD: Interviews were held either in person or by telephone. A topic guide was used to ensure consistency across the interviews. The interviews were audio-recorded, transcribed verbatim, and analysed thematically. RESULTS: GPs reported preferring to use symptom rather than diagnostic codes in order to avoid assigning potentially stigmatising labels, and because they felt diagnostic codes could encourage some patients to adopt a 'sick role'. In addition, their decision to use a diagnostic code depended on symptom severity and chronicity, and these were hard to establish in a time-limited clinical consultation. In contrast, patients commented that receiving a diagnosis helped them to understand their symptoms, and encouraged them to engage with treatment. CONCLUSION: GPs may be reluctant to diagnose an anxiety disorder, but patients can find a diagnosis helpful in terms of understanding their symptoms and the need for treatment. As limited consultation time can discourage discussions between GPs and patients, followup appointments and continuity of care may be particularly important for the management of anxiety in primary care.