Long COVID quality of life and healthcare experiences in the UK: a mixed method online survey.

PURPOSE: The complexity of long COVID and its diverse symptom profile contributes to unprecedented challenges for patients, clinicians, and healthcare services. The threat of long COVID remains ignored by Governments, the media and public health messaging, and patients' experiences must be heard through understanding of the lived experience. This study aimed to understand the lived experience of those living with long COVID. METHODS: An online web-based survey was designed using Patient and Public Involvement and Engagement (PPIE) to increase understanding of the lived experiences of long COVID, and was distributed through PPIE groups, social media, and word of mouth. The survey used closed and open questions relating to demographics, pre- and post-COVID-19 health quality of life, daily activities and long COVID experiences. RESULTS: Within our sample of 132 people living with long COVID, the findings highlight that individuals are being severely impacted by their symptoms and are unable to or limited in participating in their daily activities, reducing quality of life. Long COVID places strain on relationships, the ability to live life fully and is detrimental to mental health. Varying health care experiences are described by participants, with reports of medical gaslighting and inadequate support received. CONCLUSIONS: Long COVID has a severe impact on the ability to live life fully, and strains mental health. The appropriate mechanisms and support services are needed to support those living with long COVID and manage symptoms.

Acute COVID-19, the Lived Experience, and Lessons to Learn for Future Pandemics.

OBJECTIVES: The study aimed to increase the understanding of the lived experience of patients during the acute phase of a coronavirus disease 2019 (COVID-19) infection. METHOD: A Web-based survey was distributed through established patient and public engagement and involvement groups and networks, social media, and by means of word of mouth. The survey covered questions relating to patient demographics, COVID-19 diagnosis, symptom profile, and patient experience during acute COVID-19. RESULTS: The findings demonstrate the varying symptom profiles experienced by people in the acute stage of COVID-19 infection, with participants sharing how they managed care at home, and/or accessed medical advice. Findings also highlight themes that people were concerned with being unable to receive care and believed they needed to rely heavily on family, with extreme thoughts of death. CONCLUSIONS: Although the urgent threat to public health has been negated by efficacious vaccines and enhanced treatment strategies, there are key lessons from the lived experience of COVID-19 that should be used to prepare for future pandemics and public health emergencies.

Forming a consensus opinion to inform long COVID support mechanisms and interventions: a modified Delphi approach.

Background: Current approaches to support patients living with post-COVID condition, also known as Long COVID, are highly disparate with limited success in managing or resolving a well-documented and long-standing symptom burden. With approximately 2.1 million people living with the condition in the UK alone and millions more worldwide, there is a desperate need to devise support strategies and interventions for patients. Methods: A three-round Delphi consensus methodology was distributed internationally using an online survey and was completed by healthcare professionals (including clinicians, physiotherapists, and general practitioners), people with long COVID, and long COVID academic researchers (round 1 n = 273, round 2 n = 186, round 3 n = 138). Across the three rounds, respondents were located predominantly in the United Kingdom (UK), with 17.3-15.2% (round 1, n = 47; round 2 n = 32, round 2 n = 21) of respondents located elsewhere (United States of America (USA), Austria, Malta, United Arab Emirates (UAE), Finland, Norway, Malta, Netherlands, Iceland, Canada, Tunisie, Brazil, Hungary, Greece, France, Austrailia, South Africa, Serbia, and India). Respondents were given ∼5 weeks to complete the survey following enrolment, with round one taking place from 02/15/2022 to 03/28/22, round two; 05/09/2022 to 06/26/2022, and round 3; 07/14/2022 to 08/09/2022. A 5-point Likert scale of agreement was used and the opportunity to include free text responses was provided in the first round. Findings: Fifty-five statements reached consensus (defined as >80% agree and strongly agree), across the domains of i) long COVID as a condition, ii) current support and care available for long COVID, iii) clinical assessments for long COVID, and iv) support mechanisms and rehabilitation interventions for long COVID, further sub-categorised by consideration, inclusion, and focus. Consensus reached proposes that long COVID requires specialised, comprehensive support mechanisms and that interventions should form a personalised care plan guided by the needs of the patients. Supportive approaches should focus on individual symptoms, including but not limited to fatigue, cognitive dysfunction, and dyspnoea, utilising pacing, fatigue management, and support returning to daily activities. The mental impact of living with long COVID, tolerance to physical activity, emotional distress and well-being, and research of pre-existing conditions with similar symptoms, such as myalgic encephalomyelitis, should also be considered when supporting people with long COVID. Interpretation: We provide an outline that achieved consensus with stakeholders that could be used to inform the design and implementation of bespoke long COVID support mechanisms. Funding: None.

Lived experience of patients with Long COVID: a qualitative study in the UK.

BACKGROUND: Long COVID is a rapidly evolving global health crisis requiring interdisciplinary support strategies that incorporate the lived experience of patients. Currently, there is a paucity of research documenting the day-to-day experiences of patients living with Long COVID. OBJECTIVE: To explore the lived experience of Long COVID patients. STUDY DESIGN: Longitudinal, observation study. SETTING: An inductive, data-driven, qualitative approach was used to evaluate hand-written diaries obtained from individuals who had been referred to a Derbyshire Long COVID clinic. PARTICIPANTS: 12 participants (11 females, age 49±10 years, 11 Caucasians) were recruited. Participants were included if they had a previous confirmed or suspected COVID-19 infection with ongoing recovery, >18 years old, understood the study requirements and provided informed consent. METHOD: Participants were directed to complete self-report diaries over 16 weeks. Responses were transcribed verbatim and analysed using thematic analysis. RESULTS: Three key themes were highlighted: (1) understanding who helps patients manage symptoms, (2) daily activities and the impact on quality of life and health status and (3) the effect of turbulent and episodic symptom profiles on personal identity and recovery. CONCLUSIONS: The novel challenges presented by Long COVID are complex with varying inter-related factors that are broadly impacting functional status and quality of life. Support mechanisms must incorporate the lived experiences and foster true collaborations between health professionals, patients and researchers to improve patient outcomes. TRIAL REGISTRATION NUMBER: NCT04649957.

'I like to feel needed, you know?': a qualitative examination of sense of purpose in older care home residents.

OBJECTIVES: To explore older care home residents' experiences of maintaining a sense of purpose in life: a core component of psychological wellbeing. METHODS: Fifteen residents (9 female; 6 male), aged 60-95 years, from four care homes, were interviewed about their sense of purpose. Interview transcripts were analysed using inductive thematic analysis. RESULTS: Theme 1 ('Experiencing Loss') comprises two sub-themes that describe the impact of age-related losses on residents' sense of purpose (sub-theme 1) and the different responses that participants had to these losses (sub-theme 2). Theme 2 ('The Protective Effects of Social Connections') describes how social relationships could provide a sense of purpose, as well as the difficulties participants experienced in forming these relationships. Finally, theme 3 ('The Roles of Activities') describes the types of activities that could help residents to maintain a sense of purpose. CONCLUSION: Care home residents experience losses and barriers that make it more difficult to maintain a sense of purpose. However, with appropriate support and opportunities, residents are able to engage in activities and relationships that provide a sense of purpose. To support residents' mental health and wellbeing, care homes should offer varied opportunities for residents to engage in purposeful activities.

Estimating the Burden of Heat-Related Illness Morbidity Attributable to Anthropogenic Climate Change in North Carolina.

Climate change is known to increase the frequency and intensity of hot days (daily maximum temperature ≥30°C), both globally and locally. Exposure to extreme heat is associated with numerous adverse human health outcomes. This study estimated the burden of heat-related illness (HRI) attributable to anthropogenic climate change in North Carolina physiographic divisions (Coastal and Piedmont) during the summer months from 2011 to 2016. Additionally, assuming intermediate and high greenhouse gas emission scenarios, future HRI morbidity burden attributable to climate change was estimated. The association between daily maximum temperature and the rate of HRI was evaluated using the Generalized Additive Model. The rate of HRI assuming natural simulations (i.e., absence of greenhouse gas emissions) and future greenhouse gas emission scenarios were predicted to estimate the HRI attributable to climate change. Over 4 years (2011, 2012, 2014, and 2015), we observed a significant decrease in the rate of HRI assuming natural simulations compared to the observed. About 3 out of 20 HRI visits are attributable to anthropogenic climate change in Coastal (13.40% [IQR: -34.90,95.52]) and Piedmont (16.39% [IQR: -35.18,148.26]) regions. During the future periods, the median rate of HRI was significantly higher (78.65%: Coastal and 65.85%: Piedmont), assuming a higher emission scenario than the intermediate emission scenario. We observed significant associations between anthropogenic climate change and adverse human health outcomes. Our findings indicate the need for evidence-based public health interventions to protect human health from climate-related exposures, like extreme heat, while minimizing greenhouse gas emissions.

X-linked myotubular myopathy associated with an MTM1 variant in a Maine coon cat.

OBJECTIVE: Describe the clinical course and diagnostic and genetic findings in a cat with X-linked myotubular myopathy. CASE SUMMARY: A 7-month-old male Maine coon was evaluated for progressively worsening gait abnormalities and generalized weakness. Neurolocalization was to the neuromuscular system. Genetic testing for spinal muscular atrophy (LIX1) was negative. Given the progressive nature and suspected poor long-term prognosis, the owners elected euthanasia. Histopathology of skeletal muscle obtained post-mortem disclosed numerous rounded atrophic or hypotrophic fibers with internal nuclei or central basophilic staining. Using oxidative reactions mediated by cytochrome C oxidase and succinic dehydrogenase, scattered myofibers were observed to have central dark staining structures and a "ring-like" appearance. Given the cat's age and clinical history, a congenital myopathy was considered most likely, with the central nuclei and "ring-like" changes consistent with either centronuclear or myotubular myopathy. Whole genome sequencing identified an underlying missense variant in myotubularin 1 (MTM1), a known candidate gene for X-linked myotubular myopathy. NEW OR UNIQUE INFORMATION PROVIDED: This case is the first report of X-linked myotubular myopathy in a cat with an MTM1 missense mutation. Maine coon cat breeders may consider screening for this variant to prevent production of affected cats and to eradicate the variant from the breeding population.

Directly or Indirectly? The Role of Social Support in the Psychological Pathways Underlying Suicidal Ideation in People with Bipolar Disorder.

Contemporary theories of suicide, such as the Schematic Appraisals Model (SAMS), hypothesize that negative perceptions of social support are implicated in the pathways to suicidal experiences. The SAMS predicts that perceived social support influences suicidal ideation through appraisals of defeat and entrapment. However, such pathways have not been investigated in people who have bipolar disorder. This prospective four-month study tested the influence of perceived social support on later suicidal ideation via changes in defeat, entrapment, and hopelessness, in a sample of eighty euthymic participants with bipolar disorder (N = 62 at follow-up). Linear regression models tested the extent to which perceived social support at baseline predicted changes in suicidal ideation at four months directly and indirectly via changes in defeat, entrapment, and hopelessness. Perceived social support did not directly predict changes in suicidal ideation, but there was a significant indirect mediational pathway between perceived social support at baseline and changes in suicidal ideation over time, via changes in defeat, entrapment and hopelessness, supporting the SAMS. Psychological interventions which target negative perceptions of social support early, in tandem with addressing defeat, entrapment, and hopelessness over time, present a potentially effective approach to counter suicidal ideation in people who experience bipolar disorder.

COVID-19 patients require multi-disciplinary rehabilitation approaches to address persisting symptom profiles and restore pre-COVID quality of life.

BACKGROUND: Long-COVID diagnosis is prominent, and our attention must support those experiencing debilitating and long-standing symptoms. To establish patient pathways, we must consider the societal and economic impacts of sustained COVID-19. Accordingly, we sought to determine the pertinent areas impacting quality of life (QoL) following a COVID-19 infection. RESEARCH METHODS: Three hundred and eighty-one participants completed a web-based survey (83% female, 17% male) consisting of 70 questions across 7 sections (demographics, COVID-19 symptoms; QoL; sleep quality; breathlessness; physical activity and mental health). Mean age, height, body mass and body mass index (BMI) were 42 ± 12 years, 167.6 ± 10.4 cm, 81.2 ± 22.2 kg, and 29.1 ± 8.4 kg.m2, respectively. RESULTS: Participant health was reduced because of COVID-19 symptoms ('Good health' to 'Poor health' [P < 0.001]). Survey respondents who work reported ongoing issues with performing moderate (83%) and vigorous (79%) work-related activities. CONCLUSIONS: COVID-19 patients report reduced capacity to participate in activities associated with daily life, including employment activities. Bespoke COVID-19 support pathways must consider multi-disciplinary approaches that address the holistic needs of patients to restore pre-pandemic quality of life and address experienced health and wellbeing challenges.Plain Language Summary: The long-term impact of long-COVID has a dramatic impact upon daily activities and lifestyle. The development of bespoke support pathways to support patients must address the physical and psychological considerations to adequately restore pre-COVID quality of life and address broader societal and economic implications, especially for those that are of working age.

Enhancing Older Adults' Well-Being and Quality of Life Through Purposeful Activity: A Systematic Review of Intervention Studies.

BACKGROUND AND OBJECTIVES: Population aging represents a significant challenge for health and social care services. Older adults who engage in activities that offer a sense of purpose have significantly better physical and psychological health outcomes. However, age-related functional limitations and losses of social roles can present barriers to engaging in purposeful activity, especially for those older adults within the "oldest-old" age range (i.e., 80 years and older). This review aimed to determine the nature and effectiveness of purposeful activity interventions in older adults, aged 80 years and older, with respect to well-being and quality-of-life outcomes. RESEARCH DESIGN AND METHODS: Three databases were searched from their inception to April 2020. The search yielded 8,916 records, which resulted in eight eligible studies. RESULTS: The interventions were divided into two groups: (a) interventions that gave participants a specific functional role, such as volunteer or mentor (n = 5), and (b) interventions that supported participants to develop a new skill (n = 3). The quality of the evidence was variable. The strongest evidence was for interventions that assigned a functional role, which appeared to be somewhat effective in improving well-being outcomes. DISCUSSION AND IMPLICATIONS: There is preliminary evidence that purposeful activity interventions, particularly those that involved taking on a functional role, can improve well-being and quality-of-life outcomes in older adults aged 80 years and older. These findings have implications for professionals and carers to support older adults to access more purposeful social roles and create opportunities for helping and reciprocation.

Ultrasonographically derived caudal vena cava parameters acquired in a standing position and lateral recumbency in healthy, lightly sedated cats: a pilot study.

OBJECTIVES: The aim of this study was to determine the feasibility of ultrasonographically measuring the caudal vena cava (CVC) at the subxiphoid view of healthy, lightly sedated cats in a standing position and lateral recumbency. METHODS: This was a prospective, observational, experimental single-centre study. Twenty healthy research-purposed cats were enrolled. Two trained operators scanned each cat in two positions - standing and lateral recumbency - in a randomised order. CVC diameter was measured at the narrowest diameter during inspiration and at the widest diameter during expiration, at two anatomical locations along the CVC - where the CVC crosses the diaphragm (base) and 2 mm caudal to the diaphragm. The CVC collapsibility index (CVC-CI) was calculated for each site. Normalcy was assessed with a Shapiro-Wilk test. A one-way ANOVA with post-hoc Tukey's test was used to compare inspiratory with expiratory values within and between groups. A paired t-test compared the CVC-CI between groups (P ⩽0.05 indicated statistical significance). Spearman's correlation and Bland-Altman analysis assessed inter-operator variability. RESULTS: All ultrasonographic data passed normalcy and were reported as mean ± SD. When compared with each other, inspiratory and expiratory values were statistically different for position, location and operator (all P <0.0001). There was no statistically significant difference between lateral recumbency or standing position for inspiratory, expiratory and CVC-CI values. Inter-operator variability was substantial, with operator 2 consistently obtaining smaller measurements than operator 1. The mean CVC-CI in lateral recumbency at the base was 24% for operator 1 and 37% for operator 2. For the same site in standing position, CVC-CI was 27% and 41% for operators 1 and 2, respectively. CONCLUSIONS AND RELEVANCE: This pilot study demonstrates that it is possible to ultrasonographically measure the CVC diameter in both lateral recumbency and a standing position in healthy, lightly sedated cats. However, measurements obtained are operator dependent with variability between individuals. Further studies are needed to determine if ultrasonographic CVC assessment will prove helpful in estimating intravascular volume status in cats.

Increasing Access to Diabetes Care in Underserved Populations Using Mobile Medicine: How Point-of-Care Testing on Mobile Clinics Strengthens Hemoglobin A1c Adherence in Vulnerable and Underserved Populations.

BACKGROUND: The Center for Disease Control and Prevention (CDC) reported 26.9 million individuals a diabetes diagnosis rate of 9.4% in the United States had diabetes in 2018, equivalent to 8.2% of the population (CDC, 2020). Key government organizations have developed clinical quality indicators (CQIs) to ensure patients receive adequate care. The CQIs for comprehensive diabetes care are complex and often indicate a gap-in-care among vulnerable populations. OBJECTIVE: To evaluate if the availability of point-of-care (POC) hemoglobin A1c (HbA1c) testing in a mobile clinic increases CQIs adherence in vulnerable populations. METHODS: This evidence-based clinical practice change project (EBCPCP) focused on improving diabetic CQIs in vulnerable populations by implementing POC HbA1c testing on a federally qualified health centers (FQHC) mobile clinic. RESULTS: The results, 125 individuals having received HbA1c results, indicate having POC HgbA1c testing available on the mobile unit increased HbA1c testing. No patients had an HbA1c lab completed prior to the availability of POC testing. CONCLUSION: The availability of POC testing on a mobile clinic increases access to HbA1c for vulnerable populations which improves practice outcomes and increased CQI adherence. IMPLICATIONS FOR NURSING: The results of this EBCPCP indicate POC testing increases access to diagnostics and care.

Illness, Social Disadvantage, and Sexual Risk Behavior in Adolescence and the Transition to Adulthood.

This study investigated the influence of illness on sexual risk behavior in adolescence and the transition to adulthood, both directly and through moderation of the impact of social disadvantage. We hypothesized positive effects for social disadvantages and illness on sexual risk behavior, consistent with the development of faster life history strategies among young people facing greater life adversity. Using the first two waves of the National Longitudinal Study of Adolescent to Adult Health, we developed a mixed-effects multinomial logistic regression model predicting sexual risk behavior in three comparisons: risky nonmonogamous sex versus safer nonmonogamous sex, versus monogamous sex, and versus being sexually inactive, by social characteristics, illness, interactions thereof, and control covariates. Multiple imputation was used to address a modest amount of missing data. Subjects reporting higher levels of illness had lower odds of having safer nonmonogamous sex (OR = 0.84, p < .001), monogamous sex (OR = 0.82, p < .001), and being sexually inactive (OR = 0.74, p < .001) versus risky nonmonogamous sex, relative to subjects in better health. Illness significantly moderated the sex (OR = 0.88, p < .01), race/ethnicity (e.g., OR = 1.21, p < .001), and childhood SES (OR = 0.94; p < .01) effects for the sexually inactive versus risky nonmonogamous sex comparison. Substantive findings were generally robust across waves and in sensitivity analyses. These findings offer general support for the predictions of life history theory. Illness and various social disadvantages are associated with increased sexual risk behavior in adolescence and the transition to adulthood. Further, analyses indicate that the buffering effects of several protective social statuses against sexual risk-taking are substantially eroded by illness.

Feasibility and acceptability of integrated psychological therapy versus treatment as usual for people with bipolar disorder and co-morbid alcohol use: A single blind randomised controlled trial.

BACKGROUND: Alcohol use is a common problem in bipolar disorder (BD) and evidence indicates more promising outcomes for alcohol use than other substances. No trials have evaluated individual integrated motivational interviewing and cognitive behaviour therapy (MI-CBT) for problematic alcohol use in BD. We therefore assessed the feasibility and acceptability of a novel MI-CBT intervention for alcohol use in BD. METHODS: A single blind RCT was conducted to compare MI-CBT plus treatment as usual (TAU) with TAU only. MI-CBT was delivered over 20 sessions with participants followed up at 3, 6, 9 and 12 months post-randomisation. Primary outcomes were the feasibility and acceptability of MI-CBT (recruitment to target, retention to follow-up and therapy, acceptability of therapy and absence of adverse events). We also conducted preliminary analyses of alcohol and mood outcomes (frequency and severity of alcohol use and time to mood relapse). RESULTS: 44 participants were recruited with 75% retention to 6 and 12 months follow-up. Therapy participants attended a mean of 17.6 (SD 4.5) sessions. Therapy alliance and treatment fidelity were acceptable. Qualitative interviews indicated the intervention was experienced as collaborative, and helpful, in addressing mood and alcohol issues, although risk of overconfidence following therapy was also identified. Clinical outcomes did not differ between arms at 12 months follow-up. LIMITATIONS: As a feasibility and acceptability trial any secondary results should be treated with caution. CONCLUSIONS: Integrated MI-CBT is feasible and acceptable, but lack of clinical impact, albeit in a feasibility study, suggests need for further development. Potential adaptations are discussed.

Survey of Handlers of 158 Police Dogs in New Zealand: Functional Assessment and Canine Orthopedic Index.

Objectives: To determine the functional assessment (FA) of fitness and Canine Orthopedic Index (COI) scores of 158 police dogs. The hypothesis was the dogs would have excellent fitness and no evidence of orthopedic disease regardless of age as reported by the handlers. Study Design:Observational, prospective study. Sample Population: Handlers of dogs >1 year of age in active duty or breeding/active duty. Methods: COI and FA questionnaires were completed via e-mail. Fisher's Exact test for count data assessed scores by age group (<2 years, 2-5 years, >5 years); Wilcoxon Signed-rank test correlated COI parameters (stiffness, function, gait, quality of life) to FA. Results: The dogs were 3.2 ± 2.4 (mean ± standard deviation) years-old, 96% were German Shepherds and 111 were male. 32% of dogs could hold the "Hup" position for no longer than 4 s and 8% frequently had difficulty with this task. Difficulty jumping into vehicles occurred in 1/3 of the dogs. Overall FA was impaired in 20% (score >8), abnormal in 15% (score = 5-7), and reduced (score = 1-4) in 36% of dogs. Only 29% had normal function (FA score = 0) and these were significantly younger (2.8 ± 1.7 years, p < 0.05) than impaired dogs (6.6 ± 2.2 years). COI stiffness score was abnormal in 37% (3.3 ± 2.2) and gait was abnormal in 41% (5.4 ± 4.0). Quality of life (QOL) was excellent in 69% of dogs. Stiffness for the <2 year-old group was 0.2 ± 0.8, for the 2-5 year-old group was 1.1 ± 2.0 and for the >5 year-old group was 3.2 ± 2.4. Gait score for the <2 year group was 0.8 ± 2.2, and for the 2-5 year group was 1.9 ± 3.2 and for the >5 year group was 6.0 ± 4.3. Quality of life was close to excellent for the <2 year-olds (0.3 ± 1.1) and 2-5 year-olds (0.8 ± 2.0) but the >5 year-olds scored higher (3.0 ± 2.5). Only the COI gait score correlated with the FA score (p = 0.30). Conclusions and Clinical Relevance: Police dogs were reported by handlers to have good to excellent QOL, however, increasing age was associated with declining FA and COI scores.

Psychological resilience in people experiencing schizophrenia and suicidal thoughts and behaviours.

Background: Negative stressors can aggravate the impact of schizophrenia. However, some people find ways of combating such stressors. There is a dearth of research examining factors which enable individuals with schizophrenia to show psychological resilience.Aims: The goal of this study was to investigate resilience to negative stressors in people with disorders on the schizophrenia spectrum using a qualitative methodology.Methods: Data were collected from 23 participants who had experienced schizophrenia and suicidal thoughts and behaviours. Semi-structured interviews followed a topic guide. Participants were asked (i) what resilience meant to them, (ii) which stressors they had experienced over 12 months and (iii) how they had counteracted those stressors. Thematic analysis was conducted to identify re-occurring themes across interviews.Results: A continuum of psychological mechanisms described participants' views about the meaning of resilience which ranged from passive acceptance to resistance (e.g. withstanding pressure), and then to active strategies to counter stressors (e.g. confronting). These themes were also evident in narratives expressing personal resilience strategies but, additionally, included emotional coping techniques. External factors were highlighted that supported resilience including social support, reciprocity and religious coping.Conclusions: People with schizophrenia develop ways of being resilient to negative events which should inform therapeutic interventions.

The feasibility and acceptability of a novel anxiety in bipolar disorder intervention compared to treatment as usual: A randomized controlled trial.

BACKGROUND: Comorbid anxiety is common in bipolar disorder (BD) and associated with worse clinical outcomes including increased suicidality. Despite effective psychological treatments for anxiety, research into treating anxiety in BD is underdeveloped. This paper describes a novel psychological intervention to address anxiety in context of bipolar disorder (AIBD). METHODS: Adults with BD and clinically significant anxiety symptoms were randomized to AIBD plus treatment as usual (TAU) or TAU alone. AIBD offered 10 sessions of psychological therapy using a formulation-based approach. Feasibility and acceptability were evaluated through recruitment, retention, therapy attendance, alliance, fidelity, and qualitative feedback. Clinical outcomes were assessed at baseline, 16, 48, and 80 weeks: interim assessments of relapse at 32 and 64 weeks. RESULTS: Seventy-two participants were recruited with 88% retention to 16 weeks and 74% to 80 weeks (similar between arms). Therapy participants attended x ¯ 7.7 (SD 2.8) sessions. Therapeutic alliance and therapy fidelity were acceptable. Qualitative interviews indicated that participants valued integrated support for anxiety with BD and coping strategies. Some suggested a longer intervention period. Clinical outcomes were not significantly different between arms up to 80 weeks follow-up. CONCLUSIONS: AIBD is feasible and acceptable but lack of impact on clinical outcomes indicates that adaptations are required. These are discussed in relation to qualitative feedback and recent literature published since the trial completed.

Exploring the Potential Routine Use of Electronic Healthcare Record Data to Strengthen Early Signal Assessment in UK Medicines Regulation: Proof-of-Concept Study.

INTRODUCTION: Electronic healthcare record (EHR) databases are used within pharmacoepidemiology studies to confirm or refute safety signals arising from spontaneous adverse event reports. However, there has been limited routine use of such data earlier in the signal management process, to help rapidly contextualise signals and strengthen preliminary assessment or to inform decisions regarding action including the need for further studies. This study explores the value of EHR used in this way within a regulatory environment via an automated analysis platform. METHODS: Safety signals raised at the UK Medicines and Healthcare products Regulatory Agency (MHRA) between July 2014 and June 2015 were individually reviewed by a multi-disciplinary team. They assessed the feasibility of identifying the exposure and event of interest using primary care data from the Clinical Practice Research Datalink (CPRD) within the Commonwealth Vigilance Workbench (CVW) Longitudinal Module platform, which was designed to facilitate routine descriptive analysis of signals using EHR. Three signals, where exposure and event could be well identified, were retrospectively analysed using the platform. RESULTS: Of 69 unique new signals, 20 were for drugs prescribed predominately in secondary care or available without prescription, which would not be identified in primary care. A further 17 were brand, formulation, or dose-specific issues, were related to mortality, were relevant only to a subgroup of patients, or were drug interactions, and hence could not be reviewed using the platform given its limitations. Analyses of exposure and incidence of the adverse event could be produced using CPRD within the CMV Longitudinal Module for 32 (46%) signals. The case studies demonstrated that the data provided supporting evidence for confirming initial assessment of the signal and deciding upon the need for further action. CONCLUSIONS: CPRD can routinely provide useful early insights into clinical context when assessing a large proportion of safety signals within a regulatory environment provided that a flexible approach is adopted within the analysis platform.

Defeat and Entrapment in Bipolar Disorder: Exploring the Relationship with Suicidal Ideation from a Psychological Theoretical Perspective.

Contemporary psychological theoretical models of suicide hypothesize that defeat and entrapment underlie the development of suicidal ideation. This hypothesis has never been tested in people who experience bipolar disorder. Regression analysis revealed that defeat and entrapment significantly predicted suicidal ideation at 4-month follow-up. The relationship between defeat and suicidal ideation was mediated by total entrapment and internal entrapment, but not external entrapment. Results suggest that perceived defeat and entrapment underlie the development of prospective suicidal ideation in bipolar disorder. Findings could potentially improve the assessment of suicide risk in people who experience bipolar disorder.