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Background Normalisation Process Theory (NPT) is frequently used to inform qualitative research that aims to explain and evaluate processes that shape late-stage translation of innovations in the organisation and delivery of healthcare. A coding manual for qualitative researchers using NPT will facilitate transparent data analysis processes and will also reduce the cognitive and practical burden on researchers. Objectives (a) To simplify the theory for the user. (b) To describe the purposes, methods of development, and potential application of a coding manual that translates normalisation process theory (NPT) into an easily usable framework for qualitative analysis. (c) To present an NPT coding manual that is ready for use. Method Qualitative content analysis of papers and chapters that developed normalisation process theory, selection and structuring of theory constructs, and testing constructs against interview data and published empirical studies using NPT. Results A coding manual for NPT was developed. It consists of 12 primary NPT constructs and conforms to the Context-Mechanism-Outcome configuration of realist evaluation studies. Contexts are defined as settings in which implementation work is done, in which strategic intentions, adaptive execution, negotiating capability, and reframing organisational logics are enacted. Mechanisms are defined as the work that people do when they participate in implementation processes and include coherence-building, cognitive participation, collective action, and reflexive monitoring. Outcomes are defined as effects that make visible how things change as implementation processes proceed and include intervention mobilisation, normative restructuring, relational restructuring, and sustainment. Conclusion The coding manual is ready to use and performs three important tasks. It consolidates several iterations of theory development, makes the application of NPT simpler for the user, and links NPT constructs to realist evaluation methods. The coding manual forms the core of a translational framework for implementation research and evaluation.

Obesity is a major challenge for people with schizophrenia.AimsWe assessed whether STEPWISE, a theory-based, group structured lifestyle education programme could support weight reduction in people with schizophrenia. In this randomised controlled trial (study registration: ISRCTN19447796), we recruited adults with schizophrenia, schizoaffective disorder or first-episode psychosis from ten mental health organisations in England. Participants were randomly allocated to the STEPWISE intervention or treatment as usual. The 12-month intervention comprised four 2.5 h weekly group sessions, followed by 2-weekly maintenance contact and group sessions at 4, 7 and 10 months. The primary outcome was weight change after 12 months. Key secondary outcomes included diet, physical activity, biomedical measures and patient-related outcome measures. Cost-effectiveness was assessed and a mixed-methods process evaluation was included. Between 10 March 2015 and 31 March 2016, we recruited 414 people (intervention 208, usual care 206) with 341 (84.4%) participants completing the trial. At 12 months, weight reduction did not differ between groups (mean difference 0.0 kg, 95% CI -1.6 to 1.7, P = 0.963); physical activity, dietary intake and biochemical measures were unchanged. STEPWISE was well-received by participants and facilitators. The healthcare perspective incremental cost-effectiveness ratio was £246 921 per quality-adjusted life-year gained. Participants were successfully recruited and retained, indicating a strong interest in weight interventions; however, the STEPWISE intervention was neither clinically nor cost-effective. Further research is needed to determine how to manage overweight and obesity in people with schizophrenia.Declaration of interestR.I.G.H. received fees for lecturing, consultancy work and attendance at conferences from the following: Boehringer Ingelheim, Eli Lilly, Janssen, Lundbeck, Novo Nordisk, Novartis, Otsuka, Sanofi, Sunovion, Takeda, MSD. M.J.D. reports personal fees from Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, AstraZeneca, Janssen, Servier, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals International Inc.; and, grants from Novo Nordisk, Sanofi-Aventis, Lilly, Boehringer Ingelheim, Janssen. K.K. has received fees for consultancy and speaker for Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Servier and Merck Sharp & Dohme. He has received grants in support of investigator and investigator-initiated trials from Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Pfizer, Boehringer Ingelheim and Merck Sharp & Dohme. K.K. has received funds for research, honoraria for speaking at meetings and has served on advisory boards for Lilly, Sanofi-Aventis, Merck Sharp & Dohme and Novo Nordisk. D.Sh. is expert advisor to the NICE Centre for guidelines; board member of the National Collaborating Centre for Mental Health (NCCMH); clinical advisor (paid consultancy basis) to National Clinical Audit of Psychosis (NCAP); views are personal and not those of NICE, NCCMH or NCAP. J.P. received personal fees for involvement in the study from a National Institute for Health Research (NIHR) grant. M.E.C. and Y.D. report grants from NIHR Health Technology Assessment, during the conduct of the study; and The Leicester Diabetes Centre, an organisation (employer) jointly hosted by an NHS Hospital Trust and the University of Leicester and who is holder (through the University of Leicester) of the copyright of the STEPWISE programme and of the DESMOND suite of programmes, training and intervention fidelity framework that were used in this study. S.R. has received honorarium from Lundbeck for lecturing. F.G. reports personal fees from Otsuka and Lundbeck, personal fees and non-financial support from Sunovion, outside the submitted work; and has a family member with professional links to Lilly and GSK, including shares. F.G. is in part funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research & Care Funding scheme, by the Maudsley Charity and by the Stanley Medical Research Institute and is supported by the by the Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London.

Cognitive models propose that behavioural responses to voices maintain distress by preventing disconfirmation of negative beliefs about voices. We used Experience Sampling Methodology (ESM) to examine the hypothesized maintenance role of behavioural responses during daily life. Thirty-one outpatients with frequent voices completed a smartphone-based ESM questionnaire 10 times a day over 9 days, assessing voice-related distress; resistance and compliance responses to voices; voice characteristics (intensity and negative content); appraisals of voice dominance, uncontrollability and intrusiveness. In line with predictions, behavioural responses were associated with voice appraisals (dominance and uncontrollability), but not voice characteristics. Greater resistance and compliance were reported in moments of increased voice distress, but these associations did not persist after controlling for concurrent voice appraisals and characteristics. Voice distress was predicted by appraisals, and, unexpectedly, also by voice characteristics. As predicted, compliance and resistance were related to increases in distress at subsequent timepoints, whilst antecedent voice appraisals and characteristics had no such effect. Compliance, but not resistance, additionally predicted subsequent increases in voice uncontrollability. In both cases, the reverse models showed no association, indicating directional effects of responses on subsequent distress, and of compliance on uncontrollability appraisals. These results provide support for the cognitive model by suggesting that momentary behavioural and emotional responses to voices are associated with concurrent negative voice appraisals. Findings suggest that behavioural responses may be driven by voice appraisals, rather than directly by distress, and may in turn maintain voice appraisals and associated distress during the course of daily life.

Self-defining memories (SDMs) are vivid personal memories, related to narrative identity. Individuals with schizophrenia report less specific, more negative, and extract less meaning from these memories compared to control groups. SDMs have been shown to be predicted by neurocognition, associated with metacognition, and linked to goal outcomes in healthy controls. As neurocognition and metacognition are known predictors of poor functioning in psychosis, SDMs may also be a predictor. No study has assessed the relationship to functioning or pattern of SDMs in first episode psychosis (FEP). This was a cross-sectional study involving 71 individuals with FEP and 57 healthy controls who completed an SDM questionnaire. FEP participants completed measures of neurocognition, metacognition (Metacognitive Assessment Interview), functional capacity (The University of California, San Diego [UCSD] Performance-Based Skills Assessment), and functional outcome (Time-Use Survey). SDMs reported by individuals with FEP were less integrated compared to healthy controls. Within the FEP sample, holding less specific memories was associated with engagement in significantly fewer hours of structured activity per week and specificity of SDMs mediated the relationship between neurocognition and functional outcome, independent of metacognition. This is the first study to assess SDMs in FEP and to explore the important role of SDMs on clinical outcomes, compared to healthy controls. This study suggests that elaborating on specific SDMs is a valid therapeutic target and may be considered a tool to improve daily functioning in FEP.

Dissociation is a transdiagnostic mental health symptom involving a sense of detachment from one’s own body. A coherent percept of our body relies upon the smooth integration of different senses, such as vision and touch, which are processed by the brain at different speeds. We investigated the association between multi-sensory integration and dissociation in a N  = 100 non-clinical sample. An immersive head-mounted display provided participants with a first-person view of their body while their arm was brushed by themselves or by the researcher. This mixed-reality setup allowed for the systematic variation of a delay to the visual feed, resulting in visual information being delayed relative to other senses (e.g. touch). Larger delays were associated with greater self-reported feelings of dis-ownership from the body. In addition, participants with high trait dissociation felt elevated sensations of dis-ownership from the body and were more sensitive to the multi-sensory delay, suggesting an increased tendency to ‘fraction’ senses in dissociation. Moreover, individuals with higher dissociation displayed similar cardiac reactivity to both self and other touch. These findings highlight two key mechanisms underlying dissociation; altered sensory-integration and increased awareness of self-action.

•There is no documented evidence of measles vaccine virus transmission.•On rare occasions vaccinees present with vaccine-associated measles.•Successful vaccination strategies have enabled genotypic analysis of fewer cases. Measles is one of the most contagious human diseases. Administration of the live attenuated measles vaccine has substantially reduced childhood mortality and morbidity since its licensure in 1963. The live but attenuated form of the vaccine describes a virus poorly adapted to replicating in human tissue, but with a replication yield sufficient to elicit an immune response for long-term protection. Given the high transmissibility of the wild-type virus and that transmission of other live vaccine viruses has been documented, we conducted a systematic review to establish if there is any evidence of human-to-human transmission of the live attenuated measles vaccine virus. We reviewed 773 articles for genotypic confirmation of a vaccine virus transmitted from a recently vaccinated individual to a susceptible close contact. No evidence of human-to-human transmission of the measles vaccine virus has been reported amongst the thousands of clinical samples genotyped during outbreaks or endemic transmission and individual case studies worldwide.

Background People with psychosis have high rates of trauma, with a post-traumatic stress disorder (PTSD) prevalence rate of approximately 15%, which exacerbates psychotic symptoms such as delusions and hallucinations. Pilot studies have shown that trauma-focused (TF) psychological therapies can be safe and effective in such individuals. This trial, the largest to date, will evaluate the clinical effectiveness of a TF therapy integrated with cognitive behaviour therapy for psychosis (TF-CBTp) on post-traumatic stress symptoms in people with psychosis. The secondary aims are to compare groups on cost-effectiveness; ascertain whether TF-CBTp impacts on a range of other meaningful outcomes; determine whether therapy effects endure; and determine acceptability of the therapy in participants and therapists. Methods Rater-blind, parallel arm, pragmatic randomised controlled trial comparing TF-CBTp + treatment as usual (TAU) to TAU only. Adults ( N = 300) with distressing post-traumatic stress and psychosis symptoms from five mental health Trusts (60 per site) will be randomised to the two groups. Therapy will be manualised, lasting 9 months (m) with trained therapists. We will assess PTSD symptom severity (primary outcome); percentage who show loss of PTSD diagnosis and clinically significant change; psychosis symptoms; emotional well-being; substance use; suicidal ideation; psychological recovery; social functioning; health-related quality of life; service use, a total of four times: before randomisation; 4 m (mid-therapy); 9 m (end of therapy; primary end point); 24 m (15 m after end of therapy) post-randomisation. Four 3-monthly phone calls will be made between 9 m and 24 m assessment points, to collect service use over the previous 3 months. Therapy acceptability will be assessed through qualitative interviews with participants ( N = 35) and therapists ( N = 5–10). An internal pilot will ensure integrity of trial recruitment and outcome data, as well as therapy protocol safety and adherence. Data will be analysed following intention-to-treat principles using generalised linear mixed models and reported according to Consolidated Standards of Reporting Trials-Social and Psychological Interventions Statement. Discussion The proposed intervention has the potential to provide significant patient benefit in terms of reductions in distressing symptoms of post-traumatic stress, psychosis, and emotional problems; enable clinicians to implement trauma-focused therapy confidently in this population; and be cost-effective compared to TAU through reduced service use. Trial registration ISRCTN93382525 (03/08/20)

IntroductionAnomalous experiences are common within the general population, but the frequency and intensity is increased in young people with psychosis. Studies have demonstrated that perceptual biases towards noticing these phenomena plays a role, but the way one thinks about one’s experience (metacognition) may also be relevant. While poor metacognitive function has been theoretically associated with anomalous experiences, this relationship is currently unclear. However, metacognition may work along a continuum with various metacognitive levels, many of which have been demonstrated as impaired in psychosis. These metacognitive components may interact via processes that maintain poor metacognition across levels, and that potentially impact both what people do in their everyday lives (functional outcome) and how people feel about their everyday lives (subjective recovery outcome) in young people with psychosis compared with healthy control participants.Methods and analysisThis study will investigate the association and contribution of metacognition to anomalous experiences and outcome measures cross-sectionally and longitudinally in a 36-month follow-up. First, young people with psychosis will be compared with healthy control participants on selected measures of anomalous experience, metacognition, and function, using analysis of covariance to identify group differences. Next, the relationship between metacognitive components and processes will be explored, including processes connecting the different components, using regression analyses. Finally, mediation analyses will be used to assess the predictive value of metacognitive measures on outcome measures, both cross-sectionally and longitudinally at 36 months, while controlling for symptoms and cognition.Ethics and disseminationEthical and Health Research Authority approval has been obtained through Camberwell St. Giles Research Ethics Committee (reference number: 17/LO/0055). This research project will be reported within a PhD thesis and submitted for journal publication. Once key predictive components of poor outcome in psychosis are identified, this study will develop a series of dynamic models to understand influences on outcome for young people with psychosis.

Preventing relapses of psychosis is difficult and important. Digital remote monitoring (DRM) systems are being developed and tested to support this. Increasingly, these systems use algorithm-based relapse prediction. Hence, understanding stakeholder views about algorithmic prediction is crucial. Existing qualitative work has explored health professionals' views, but very few studies have examined the perspectives of people with psychosis on this topic. This paper aimed to provide an in-depth examination of the views of people with psychosis regarding algorithmic relapse prediction within a DRM system that incorporates active symptom monitoring and passive sensing data. People with psychosis (n=58) were recruited from 6 geographically distinct areas of the United Kingdom. They participated in semistructured qualitative interviews exploring their views about using a DRM system that predicts psychosis relapse based on a machine learning algorithm. Transcripts were analyzed using reflexive thematic analysis. People with lived experience of psychosis were involved extensively in study design, analysis, and reporting. Findings were described across 4 themes. First, accuracy was a prominent theme. Participants emphasized that transparency about algorithm sensitivity and specificity is crucial and discussed the risks of the relapse prediction algorithm producing false positives (flagging that someone was relapsing when they were not) and false negatives (missing actual relapses). In both cases, participants said that errors may be partially mitigated through a human-in-the-loop approach (theme 2), with DRM blended with human oversight, from clinicians or a dedicated digital monitoring team, and calibrated based on service user, carer, and clinician feedback. The third theme, trust, fears, and choice, noted the interplay between users' trust in the DRM system and their relationship with the clinical team. This theme described participants' fears about potential overreactions (hospitalization or excessive medication) or underreactions (no additional support) from the clinical team in response to algorithm-generated relapse predictions. It emphasized the importance of retaining choice around the use of relapse detection algorithms and the sharing of personal data. The final theme described participants' views about the benefits of using a relapse prediction algorithm, including facilitating early intervention, triaging care according to need, minimizing human bias in assessment, and efficiency in saving staff time. People with psychosis acknowledged potential benefits of algorithm-assisted relapse prediction for receiving timely or efficient care, but with several caveats. Algorithm-generated relapse alerts need to be sufficiently accurate and must be interpreted, with understanding of their limitations, by a trustworthy human who is aware of the relevant context. Algorithm-based relapse predictions should only be used with valid consent, in a way that promotes and respects the autonomy and voice of service users and avoids increasing the use of excessive restriction.

The first episode of psychosis is a critical period in the emergence of cardiometabolic risk. We set out to explore the influence of individual and lifestyle factors on cardiometabolic outcomes in early psychosis. This was a prospective cohort study of 293 UK adults presenting with first-episode psychosis investigating the influence of sociodemographics, lifestyle (physical activity, sedentary behaviour, nutrition, smoking, alcohol, substance use) and medication on cardiometabolic outcomes over the following 12 months. Rates of obesity and glucose dysregulation rose from 17.8% and 12%, respectively, at baseline to 23.7% and 23.7% at 1 year. Little change was seen over time in the 76.8% tobacco smoking rate or the quarter who were sedentary for over 10 h daily. We found no association between lifestyle at baseline or type of antipsychotic medication prescribed with either baseline or 1-year cardiometabolic outcomes. Median haemoglobin A1c (HbA1c) rose by 3.3 mmol/mol in participants from Black and minority ethnic (BME) groups, with little change observed in their White counterparts. At 12 months, one-third of those with BME heritage exceeded the threshold for prediabetes (HbA1c >39 mmol/mol). Unhealthy lifestyle choices are prevalent in early psychosis and cardiometabolic risk worsens over the next year, creating an important window for prevention. We found no evidence, however, that preventative strategies should be preferentially directed based on lifestyle habits. Further work is needed to determine whether clinical strategies should allow for differential patterns of emergence of cardiometabolic risk in people of different ethnicities.