The adolescent HIV executive function and drumming (AHEAD) study, a feasibility trial of a group drumming intervention amongst adolescents with HIV.

AHEAD feasibility trial assessed the feasibility and acceptability of an 8-session group drumming programme aiming to improve executive function, depression and anxiety symptoms, and perceived social support in adolescents living with HIV in a rural low-income South African setting. Sixty-eight 12- to 19-year-old adolescents participated. They were individually randomised. The intervention arm (n = 34) received weekly hour-long group drumming sessions. Controls (n = 34) received no intervention. Feasibility and acceptability were assessed using rates of: enrolment; retention; attendance; logistical problems; adolescent-reported acceptability. Secondary measures included: five Oxford Cognitive Screen-Executive Function (OCS-EF) tasks; two Rapid Assessment of Cognitive and Emotional Regulation (RACER) tasks; the Self-Reporting Questionnaire-20 (SRQ-20) measuring depression and anxiety symptoms; the Multidimensional Scale of Perceived Social Support (MSPSS). All feasibility criteria were within green progression limits. Enrolment, retention, and acceptability were high. There was a positive effect on adolescent depressed mood with signal for a working memory effect. There were no significant effects on executive function or socio-emotional scales. Qualitative findings suggested socio-emotional benefits including: group belonging; decreased internalised stigma; improved mood; decreased anxiety. Group drumming is a feasible and acceptable intervention amongst adolescents living with HIV in rural South Africa. A full-scale trial is recommended.

Efficacy of self-monitored blood pressure, with or without telemonitoring, for titration of antihypertensive medication (TASMINH4): an unmasked randomised controlled trial.

BACKGROUND: Studies evaluating titration of antihypertensive medication using self-monitoring give contradictory findings and the precise place of telemonitoring over self-monitoring alone is unclear. The TASMINH4 trial aimed to assess the efficacy of self-monitored blood pressure, with or without telemonitoring, for antihypertensive titration in primary care, compared with usual care. METHODS: This study was a parallel randomised controlled trial done in 142 general practices in the UK, and included hypertensive patients older than 35 years, with blood pressure higher than 140/90 mm Hg, who were willing to self-monitor their blood pressure. Patients were randomly assigned (1:1:1) to self-monitoring blood pressure (self-montoring group), to self-monitoring blood pressure with telemonitoring (telemonitoring group), or to usual care (clinic blood pressure; usual care group). Randomisation was by a secure web-based system. Neither participants nor investigators were masked to group assignment. The primary outcome was clinic measured systolic blood pressure at 12 months from randomisation. Primary analysis was of available cases. The trial is registered with ISRCTN, number ISRCTN 83571366. FINDINGS: 1182 participants were randomly assigned to the self-monitoring group (n=395), the telemonitoring group (n=393), or the usual care group (n=394), of whom 1003 (85%) were included in the primary analysis. After 12 months, systolic blood pressure was lower in both intervention groups compared with usual care (self-monitoring, 137·0 [SD 16·7] mm Hg and telemonitoring, 136·0 [16·1] mm Hg vs usual care, 140·4 [16·5]; adjusted mean differences vs usual care: self-monitoring alone, -3·5 mm Hg [95% CI -5·8 to -1·2]; telemonitoring, -4·7 mm Hg [-7·0 to -2·4]). No difference between the self-monitoring and telemonitoring groups was recorded (adjusted mean difference -1·2 mm Hg [95% CI -3·5 to 1·2]). Results were similar in sensitivity analyses including multiple imputation. Adverse events were similar between all three groups. INTERPRETATION: Self-monitoring, with or without telemonitoring, when used by general practitioners to titrate antihypertensive medication in individuals with poorly controlled blood pressure, leads to significantly lower blood pressure than titration guided by clinic readings. With most general practitioners and many patients using self-monitoring, it could become the cornerstone of hypertension management in primary care. FUNDING: National Institute for Health Research via Programme Grant for Applied Health Research (RP-PG-1209-10051), Professorship to RJM (NIHR-RP-R2-12-015), Oxford Collaboration for Leadership in Applied Health Research and Care, and Omron Healthcare UK.

Screening and brief intervention for obesity in primary care: cost-effectiveness analysis in the BWeL trial.

BACKGROUND: The Brief Intervention for Weight Loss Trial enrolled 1882 consecutively attending primary care patients who were obese and participants were randomised to physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice). After one year, the support group lost 1.4 kg more (95%CI 0.9 to 2.0): 2.4 kg versus 1.0 kg. We use a cohort simulation to predict effects on disease incidence, quality of life, and healthcare costs over 20 years. METHODS: Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity. We applied the weight loss observed in the trial and assumed weight regain over four years. Using epidemiological data, we assigned the incidence of 12 weight-related diseases depending on baseline disease status, age, gender, body mass index. From a healthcare perspective, we calculated the quality adjusted life years (QALYs) accruing and calculated the incremental difference between trial arms in costs expended in delivering the intervention and healthcare costs accruing. We discounted future costs and benefits at 1.5% over 20 years. RESULTS: Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease. The incremental cost of support over advice was £2.01million/100,000. However, the support intervention reduced health service costs by £5.86 million/100,000 leading to a net saving of £3.85 million/100,000. The support intervention produced 992 QALYs/100,000 people relative to advice. CONCLUSIONS: A brief intervention in which physicians opportunistically endorse, offer, and facilitate a referral to a behavioural weight management service to patients with a BMI of at least 30 kg/m2 reduces healthcare costs and improves health more than advising weight loss.

Cognitive Behavioural Therapy for Nightmares for Patients with Persecutory Delusions (Nites): An Assessor-Blind, Pilot Randomized Controlled Trial.

OBJECTIVE: Nightmares are relatively common in patients experiencing psychosis but rarely assessed or treated. Nightmares may maintain persecutory delusions by portraying fears in sensory-rich detail. We tested the potential benefits of imagery-focused cognitive behavioural therapy (CBT) for nightmares on nightmare severity and persecutory delusions. METHOD: This assessor-blind parallel-group pilot trial randomized 24 participants with nightmares and persecutory delusions to receive CBT for nightmares delivered over 4 weeks in addition to treatment as usual (TAU) or TAU alone. Assessments were at 0, 4 (end of treatment), and 8 weeks (follow-up). Feasibility outcomes assessed therapy uptake, techniques used, satisfaction, and attrition. The primary efficacy outcome assessed nightmare severity at week 4. Analyses were intention to treat, estimating treatment effect with 95% confidence intervals (CIs). RESULTS: All participants offered CBT completed therapy (mean [SD], 4.8 [0.6] sessions) with high satisfaction, and 20 (83%) participants completed all assessments. Compared with TAU, CBT led to large improvements in nightmares (adjusted mean difference = -7.0; 95% CI, -12.6 to -1.3; d = -1.1) and insomnia (6.3; 95% CI, 2.6 to 10.0; d = 1.4) at week 4. Gains were maintained at follow-up. Suicidal ideation was not exacerbated by CBT but remained stable to follow-up, compared with TAU, which reduced at follow-up (6.8; 95% CI, 0.3 to 3.3; d = 0.7). CBT led to reductions in paranoia (-20.8; 95% CI, -43.2 to 1.7; d = -0.6), although CIs were wide. Three serious adverse events were deemed unrelated to participation (CBT = 2, TAU = 1). CONCLUSIONS: CBT for nightmares is feasible and may be efficacious for treating nightmares and comorbid insomnia for patients with persecutory delusions. It shows promise on paranoia but potentially not on suicidal ideation.

Stabilising sleep for patients admitted at acute crisis to a psychiatric hospital (OWLS): an assessor-blind pilot randomised controlled trial.

BACKGROUND: When patients are admitted onto psychiatric wards, sleep problems are highly prevalent. We carried out the first trial testing a psychological sleep treatment at acute admission (Oxford Ward sLeep Solution, OWLS). METHODS: This assessor-blind parallel-group pilot trial randomised patients to receive sleep treatment at acute crisis [STAC, plus standard care (SC)], or SC alone (1 : 1). STAC included cognitive-behavioural therapy (CBT) for insomnia, sleep monitoring and light/dark exposure for circadian entrainment, delivered over 2 weeks. Assessments took place at 0, 2, 4 and 12 weeks. Feasibility outcomes assessed recruitment, retention of participants and uptake of the therapy. Primary efficacy outcomes were the Insomnia Severity Index and Warwick-Edinburgh Mental Wellbeing Scale at week 2. Analyses were intention-to-treat, estimating treatment effect with 95% confidence intervals. RESULTS: Between October 2015 and July 2016, 40 participants were recruited (from 43 assessed eligible). All participants offered STAC completed treatment (mean sessions received = 8.6, s.d. = 1.5). All participants completed the primary end point. Compared with SC, STAC led to large effect size (ES) reductions in insomnia at week 2 (adjusted mean difference -4.6, 95% CI -7.7 to -1.4, ES -0.9), a small improvement in psychological wellbeing (adjusted mean difference 3.7, 95% CI -2.8 to 10.1, ES 0.3) and patients were discharged 8.5 days earlier. One patient in the STAC group had an adverse event, unrelated to participation. CONCLUSIONS: In this challenging environment for research, the trial was feasible. Therapy uptake was high. STAC may be a highly effective treatment for sleep disturbance on wards with potential wider benefits on wellbeing and admission length.

Group-Based Worry Intervention for Persecutory Delusions: an Initial Feasibility Study.

BACKGROUND: A one-to-one cognitive behavioural therapy intervention targeting worry significantly reduces both worry and persecutory delusions (Freeman et al., 2015). AIM: To adapt this intervention for group delivery and conduct a feasibility trial within routine clinical practice. METHOD: Thirteen participants were randomized to a weekly 8-session worry intervention group (n = 7) or wait-list control (n = 6). RESULTS: All but one participant completed measures at all time points. Participants attended an average of six therapy sessions. CONCLUSIONS: Recruitment, retention and therapy uptake were feasible. Observed treatment effects were in the expected direction, but may be diluted compared with one-to-one interventions.

Screening and brief intervention for obesity in primary care: a parallel, two-arm, randomised trial.

BACKGROUND: Obesity is a common cause of non-communicable disease. Guidelines recommend that physicians screen and offer brief advice to motivate weight loss through referral to behavioural weight loss programmes. However, physicians rarely intervene and no trials have been done on the subject. We did this trial to establish whether physician brief intervention is acceptable and effective for reducing bodyweight in patients with obesity. METHODS: In this parallel, two-arm, randomised trial, patients who consulted 137 primary care physicians in England were screened for obesity. Individuals could be enrolled if they were aged at least 18 years, had a body-mass index of at least 30 kg/m2 (or at least 25 kg/m2 if of Asian ethnicity), and had a raised body fat percentage. At the end of the consultation, the physician randomly assigned participants (1:1) to one of two 30 s interventions. Randomisation was done via preprepared randomisation cards labelled with a code representing the allocation, which were placed in opaque sealed envelopes and given to physicians to open at the time of treatment assignment. In the active intervention, the physician offered referral to a weight management group (12 sessions of 1 h each, once per week) and, if the referral was accepted, the physician ensured the patient made an appointment and offered follow-up. In the control intervention, the physician advised the patient that their health would benefit from weight loss. The primary outcome was weight change at 12 months in the intention-to-treat population, which was assessed blinded to treatment allocation. We also assessed asked patients' about their feelings on discussing their weight when they have visited their general practitioner for other reasons. Given the nature of the intervention, we did not anticipate any adverse events in the usual sense, so safety outcomes were not assessed. This trial is registered with the ISRCTN Registry, number ISRCTN26563137. FINDINGS: Between June 4, 2013, and Dec 23, 2014, we screened 8403 patients, of whom 2728 (32%) were obese. Of these obese patients, 2256 (83%) agreed to participate and 1882 were eligible, enrolled, and included in the intention-to-treat analysis, with 940 individuals in the support group and 942 individuals in the advice group. 722 (77%) individuals assigned to the support intervention agreed to attend the weight management group and 379 (40%) of these individuals attended, compared with 82 (9%) participants who were allocated the advice intervention. In the entire study population, mean weight change at 12 months was 2·43 kg with the support intervention and 1·04 kg with the advice intervention, giving an adjusted difference of 1·43 kg (95% CI 0·89-1·97). The reactions of the patients to the general practitioners' brief interventions did not differ significantly between the study groups in terms of appropriateness (adjusted odds ratio 0·89, 95% CI 0·75-1·07, p=0·21) or helpfulness (1·05, 0·89-1·26, p=0·54); overall, four (<1%) patients thought their intervention was inappropriate and unhelpful and 1530 (81%) patients thought it was appropriate and helpful. INTERPRETATION: A behaviourally-informed, very brief, physician-delivered opportunistic intervention is acceptable to patients and an effective way to reduce population mean weight. FUNDING: The UK National Prevention Research Initiative.

Influence of spatial environment on maze learning in an African mole-rat.

In subterranean species where excavation is energetically expensive, efficient spatial navigation is vital to reducing the costs of locating important resources such as food and mates. While spatial navigational ability is positively correlated with sociality in subterranean mammals, we have a less clear understanding of the role of habitat complexity on navigational ability. We tested spatial navigational ability and memory in 12-18-month captive Natal mole-rats (Cryptomys hottentotus natalensis) maintained in a simple environment with no environmental enrichment and newly captured wild individuals from natural, complex burrow systems. In maze trials, mole-rats captured freshly from the wild made significantly fewer navigational errors, were more likely to successfully navigate the maze, travelled shorter distances and as a consequence, completed the maze in less time. Male mole-rats from both experimental treatments were more likely to complete the maze than females. Memory retention of the maze was tested on day two, seven, 30 and 60, respectively. The results were variable, although both groups showed a significant memory retention 60 days after testing. Our results highlight the potential importance of the environment (microhabitat complexity) on spatial cognitive performance in mole-rats.

Does raising heart rate prior to a behavioural test enhance learning in cognitive therapy for anxiety? An experimental test for the treatment of fear of heights using virtual reality.

BACKGROUND: A key clinical issue is how to maximise the belief change central to cognitive therapy. Physiological arousal is a key internal cue confirming threat beliefs in anxiety disorders. Deeper extinction of anxiety may occur if catastrophizing responses to physiological arousal are inhibited prior to joint exposure with external phobic stimuli. The aim of the study was to test whether increasing physiological arousal using exercise increases the benefits of behavioural tests. METHODS: Sixty individuals with a fear of heights had one session of VR cognitive treatment. They were randomised to have the treatment either with periods of intense physical exercise (cycling at 80% of maximum heart rate) prior to exposures or without. Linear mixed effects models were used to check the manipulation and test the primary hypothesis of a group difference in degree of conviction in the phobic threat belief. RESULTS: Heart rate was significantly higher in the exercise group throughout compared with the control group. Both groups showed significant reductions in threat beliefs after the VR treatment (d = 1.0, p < 0.001) but there was no significant group difference (d = 0.1, p = 0.56). DISCUSSION: An increase in physiological arousal achieved via exercise did not enhance cognitive change in beliefs about feared stimuli.

Effect of weight loss on cardiometabolic risk: observational analysis of two randomised controlled trials of community weight-loss programmes.

BACKGROUND: Guidelines recommend that clinicians identify individuals at high cardiometabolic risk and support weight loss in those with overweight or obesity. However, we lack individual level data quantifying the benefits of weight change for individuals to guide consultations in primary care. AIM: To examine how weight change affects cardiometabolic risk factors, and to facilitate shared decision making between patients and clinicians regarding weight loss. DESIGN AND SETTING: Observational analysis using data from two trials of referral of individuals with overweight or obesity in primary care to community weight-loss groups. METHOD: Linear mixed effects regression modelling examining the association between weight change and change in systolic blood pressure (SBP), diastolic blood pressure (DBP), fasting glucose, glycated haemoglobin (HbA1c), and lipid profile across multiple timepoints (baseline to 24 months). Subgroup analyses examined changes in individuals with hypertension, diabetes, and hyperlipidaemia. RESULTS: In total, 2041 participants had a mean (standard deviation) age of 50 (SD 13.5) years, mean baseline weight of 90.6 (14.8) kg and mean body mass index (BMI) of 32.7 (SD 4.1) kg/m2. Mean (SD) weight change was -4.3 (SD 6.0) kg. All outcome measures showed statistically significant improvements. Each 1 kg weight loss was associated with 0.4 mmHg reduction in SBP and 0.3 mmHg reduction in DBP, or 0.5 mmHg and 0.4 mmHg/kg respectively in people with hypertension. Each 1 kg weight loss was associated with 0.2 mmol/mol reduction in HbA1c, or 0.6 mmol/mol in people with diabetes. Effects on plasma lipids were negligible. CONCLUSION: Weight loss achieved through referral to community weight-loss programmes, which are commonly accessible in primary care, can lead to clinically relevant reductions in BP and glucose regulation, especially in those at highest risk.

Gender differences in response to an opportunistic brief intervention for obesity in primary care: Data from the BWeL trial.

Weight loss programmes appeal mainly to women, prompting calls for gender-specific programmes. In the United Kingdom, general practitioners (GPs) refer nine times as many women as men to community weight loss programmes. GPs endorsement and offering programmes systematically could reduce this imbalance. In this trial, consecutively attending patients in primary care with obesity were invited and 1882 were enrolled and randomized to one of two opportunistic 30-second interventions to support weight loss given by GPs in consultations unrelated to weight. In the support arm, clinicians endorsed and offered referral to a weight loss programme and, in the advice arm, advised that weight loss would improve health. Generalized linear mixed effects models examined whether gender moderated the intervention. Men took effective weight loss action less often in both arms (support: 41.6% vs 60.7%; advice: 12.1% vs 18.3%; odds ratio (OR) = 0.38, 95% confidence interval (CI), 0.27, 0.52, P < .001) but there was no evidence that the relative effect differed by gender (interaction P = .32). In the support arm, men accepted referral and attended referral less often, 69.3% vs 82.4%; OR = 0.48, 95% CI, 0.35, 0.66, P < .001 and 30.4% vs 47.6%; OR = 0.48, 95% CI, 0.36, 0.63, P < .001, respectively. Nevertheless, the gender balance in attending weight loss programmes closed to 1.6:1. Men and women attended the same number of sessions (9.7 vs 9.1 sessions, P = .16) and there was no evidence weight loss differed by gender (6.05 kg men vs 4.37 kg women, P = .39). Clinician-delivered opportunistic 30-second interventions benefits men and women equally and reduce most of the gender imbalance in attending weight loss programmes.

Neurocognitive processes in d-cycloserine augmented single-session exposure therapy for anxiety: A randomized placebo-controlled trial.

Drugs targeting N-methyl-d-aspartate (NMDA) receptors and the ability to learn new associations have been proposed as adjunct treatments to boost the success of exposure therapy for anxiety disorders. However, the effects of the NMDA partial agonist d-cycloserine on psychological treatment have been mixed. We investigated potential neurocognitive mechanisms underlying the clinical effects of d-cycloserine-augmented exposure, to inform the optimal combination of this and similar agents with psychological treatment. Panic disorder patients were randomised to single-dose d-cycloserine (250 mg; N = 17) or matching placebo (N = 16) 2hrs before one session of exposure therapy. Neurocognitive markers were assessed one day after treatment, including reaction-time based threat bias for fearful faces (primary outcome) and amygdala response to threat (secondary outcome). Clinical symptom severity was measured the day before and after treatment, and at 1- and 6-months follow-up (secondary outcome). d-cycloserine was associated with greater clinical recovery at 1-month follow-up than placebo (d-cyloserine 71% vs placebo 25%), with the placebo group matching the clinical gains of the d-cycloserine group during 6-months follow-up (d-cycloserine 71% vs placebo 44%). One day after treatment, threat bias for fearful faces and amygdala threat response was lower in the drug compared to placebo group. Lower amygdala magnitude predicted greater clinical improvement during follow-up across groups. While this experimental study is of a preliminary nature due to the limited sample size, these findings highlight a neurocognitive potential mechanism by which d-cycloserine may exert its augmentative effects on psychological treatment and bring forward a marker that may help understand and facilitate development of combination treatments for anxiety. (d-cycloserine Augmented CBT for Panic Disorder; clinicaltrials.gov; NCT01680107).

Virtual reality clinical-experimental tests of compassion treatment techniques to reduce paranoia.

Paranoia may build on negative beliefs held both about the self and others. Compassionate imagery may be one way of reducing such negative beliefs, and hence paranoia. Two studies tested this idea, one targeting compassion for the self and one targeting compassion for others. Two-hundred individuals from the general population scoring highly for paranoia were recruited. The studies used a randomised controlled experimental design, with embedded tests for mediation. Study one targeted self-compassion via creation of a compassionate coach (CC) image. Study two targeted compassion for others via loving kindness meditation (LKM). Individuals repeatedly entered neutral virtual reality social environments. Changes in compassion and paranoia were assessed. Compared to controls, the CC group increased in self-compassion (group difference = 2.12, C.I. = 1.57;2.67, p = <0.0001, d = 1.4) and decreased in paranoia (group difference = -1.73, C.I. = -2.48; -0.98, p = <0.0001, d = 0.8). Change in self-compassion explained 57% of change in paranoia. Compared to controls, the LKM group increased their compassion for others (group difference = 3.26, C.I. = 2.72;3.80, p = <0.0001, d = 1.7), and decreased in paranoia (group difference = -1.70, C.I. = -2.50; -0.89, p = <0.0001, d = 0.8). Change in compassion for others explained 67% of change in paranoia. Targeting negative beliefs about the self and others using compassionate imagery causes reductions in paranoia. Tests in clinical populations are indicated.

Cognitive processes associated with sudden gains in cognitive therapy for posttraumatic stress disorder in routine care.

OBJECTIVE: Although most studies investigating sudden gains in treatments for posttraumatic stress disorder (PTSD) report a positive association between sudden gains and outcomes at the end of treatment, less is known about sudden gains in routine clinical care and the processes involved in their occurrence. This study investigated changes in cognitive factors (negative appraisals, trauma memory characteristics) before, during, and after sudden gains in PTSD symptom severity. METHOD: Two samples (N1 = 248, N2 = 234) of patients who received trauma-focused cognitive therapy for PTSD in routine clinical care were analyzed. Mahalanobis distance matching, including the propensity score, was used to compare patients with sudden gains and similar patients without sudden gains. Estimates from both samples were meta-analyzed to obtain pooled effects. RESULTS: Patients with sudden gains (n1 = 76, n2 = 87) reported better treatment outcomes in PTSD symptom severity, depression, and anxiety at the end of therapy and follow-up than those without sudden gains. No baseline predictors of sudden gains could be reliably identified. During sudden gains, those with sudden gains had greater changes in both cognitive factors than matched patients. Meta-analyses of the two samples showed that negative appraisals had already decreased in the session prior to sudden gains compared with matched patients. CONCLUSIONS: The pooled estimates suggest that changes in negative trauma-related appraisals precede sudden gains in PTSD symptoms. The results suggest that interventions that promote change in appraisals may also facilitate sudden gains in therapy. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials.

INTRODUCTION: Self-monitoring of blood pressure (BP) in pregnancy could improve the detection and management of pregnancy hypertension, while also empowering and engaging women in their own care. Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2). METHODS AND ANALYSES: Both are multicentre, non-masked, parallel group, randomised controlled trials. Participants will be randomised to self-monitoring with telemonitoring or usual care. BUMP 1 will recruit a minimum of 2262 pregnant women at higher risk of pregnancy hypertension and BUMP 2 will recruit a minimum of 512 pregnant women with either gestational or chronic hypertension. The BUMP 1 primary outcome is the time to the first recording of raised BP by a healthcare professional. The BUMP 2 primary outcome is mean systolic BP between baseline and delivery recorded by healthcare professionals. Other outcomes will include maternal and perinatal outcomes, quality of life and adverse events. An economic evaluation of BP self-monitoring in addition to usual care compared with usual care alone will be assessed across both study populations within trial and with modelling to estimate long-term cost-effectiveness. A linked process evaluation will combine quantitative and qualitative data to examine how BP self-monitoring in pregnancy is implemented and accepted in both daily life and routine clinical practice. ETHICS AND DISSEMINATION: The trials have been approved by a Research Ethics Committee (17/WM/0241) and relevant research authorities. They will be published in peer-reviewed journals and presented at national and international conferences. If shown to be effective, BP self-monitoring would be applicable to a large population of pregnant women. TRIAL REGISTRATION NUMBER: NCT03334149.

A Population-based Observational Study of Childhood Encephalitis in Children Admitted to Pediatric Intensive Care Units in England and Wales.

BACKGROUND: Encephalitis is a serious neurologic condition that can result in admission to intensive care. Yet, there are no studies on pediatric intensive care unit (PICU) admission rates and usage of intensive care resources by children with encephalitis in England and Wales. The objectives of this study were to (1) define the PICU incidence and mortality rates for childhood encephalitis, (2) describe the usage of intensive care resources by children with encephalitis admitted to PICU and (3) explore the associated cost from PICU encephalitis admissions. METHODS: Retrospective analysis of anonymized data for 1031 children (0-17 years) with encephalitis admitted (January 2003 to December 2013) to PICU in England and Wales. RESULTS: The PICU encephalitis incidence was 0.79/100,000 population/yr (95% confidence interval [CI]: 0.74-0.84), which gives an annual total of 214 bed days of intensive care occupancy for children admitted with encephalitis and an estimated annual PICU bed cost of £414,230 (interquartile range: 198,111-882,495) for this cohort. PICU encephalitis admissions increased during the study period (annual percentage change = 4.5%, 95% CI: 2.43%-6.50%, P ≤ 0.0001). In total, 808/1024 (78.9%) cases received invasive ventilation while 216/983 (22.0%) and 50/890 (5.6%) cases received vasoactive treatment and renal support, respectively. There were 87 deaths (8.4%), giving a PICU encephalitis mortality rate of 0.07/100,000 population (0-17 years)/yr (95% CI: 0.05-0.08). CONCLUSIONS: These data suggest that encephalitis places a significant burden to the healthcare service. More work is needed to improve outcomes for children with encephalitis.

A randomised controlled trial of blood pressure self-monitoring in the management of hypertensive pregnancy. OPTIMUM-BP: A feasibility trial.

OBJECTIVE: To assess the feasibility of a blood pressure self-monitoring intervention for managing pregnancy hypertension. STUDY DESIGN: OPTIMUM-BP was an unmasked randomised controlled trial comparing a self-monitoring of blood pressure (SMBP) intervention versus usual care for the management of pregnancy hypertension. Women with chronic (CH) or gestational hypertension (GH) from 4 UK centres were randomised (2:1) intervention to control. Self-monitoring involved daily home blood pressure (BP) measurements, with recording via study diary or telemonitoring. Clinicians were invited to use the home readings in clinical and antihypertensive titration decisions. MAIN OUTCOMES: The primary outcomes were recruitment, retention, adherence and persistence with the intervention. RESULTS: Women from four UK centres were randomised: 158/222 (71%) of those approached agreed, comprising: 86 women with chronic hypertension (55 SMBP, 31 control) and 72 with gestational hypertension (49 SMBP, 23 control) of whom outcome data were available from 154 (97%) and were included in the analysis. The median (IQR) number of days with home BP readings per week were 5.5 (3.1-6.5) for those with chronic hypertension and 6.1 (4.5-6.7) with gestational hypertension. Participants persisted with the intervention for 80% or more of their time from enrolment until delivery in 86% (43/50) and 76% (38/49) of those with chronic and gestational hypertension respectively. Recorded clinic and study BPs were similar for both groups. CONCLUSIONS: This is the first randomised investigation of BP self-monitoring for the management of pregnancy hypertension and indicates that a large RCT would be feasible.

Cost-Effectiveness of Telemonitoring and Self-Monitoring of Blood Pressure for Antihypertensive Titration in Primary Care (TASMINH4).

The use of self-monitoring of blood pressure, with or without telemonitoring, to guide therapy decisions by physicians for patients with hypertension has been recently demonstrated to reduce blood pressure compared with using clinic monitoring (usual care). However, both the cost-effectiveness of these strategies compared with usual care, and whether the additional benefit of telemonitoring compared with self-monitoring alone could be considered value for money, are unknown. This study assessed the cost-effectiveness of physician titration of antihypertensive medication using self-monitored blood pressure, with or without telemonitoring, to make hypertension treatment decisions in primary care compared with usual care. A Markov patient-level simulation model was developed taking a UK Health Service/Personal Social Services perspective. The model adopted a lifetime time horizon with 6-month time cycles. At a willingness to pay of £20 000 per quality-adjusted life year, self-monitoring plus telemonitoring was the most cost-effective strategy (£17 424 per quality-adjusted life year gained) compared with usual care or self-monitoring alone (posting the results to the physician). However, deterministic sensitivity analysis showed that self-monitoring alone became the most cost-effective option when changing key assumptions around long-term effectiveness and time horizon. Overall, probabilistic sensitivity analysis suggested that self-monitoring regardless of transmission modality was likely to be cost-effective compared with usual care (89% probability of cost-effectiveness at £20 000/quality-adjusted life year), with high uncertainty as to whether telemonitoring or self-monitoring alone was the most cost-effective option. Self-monitoring in clinical practice is cost-effective and likely to lead to reduced cardiovascular mortality and morbidity.

Insomnia, negative affect, and psychotic experiences: Modelling pathways over time in a clinical observational study.

Insomnia has been shown to contribute to the development of psychotic experiences, predominantly via increasing negative affect. However, the role of insomnia in the persistence of psychotic experiences is yet to be investigated in a clinical population. Furthermore, other plausible influences, such as psychotic experiences contributing to insomnia, remain to be evaluated. This study tests the role of insomnia as a predictor of persistence of psychotic experiences versus other potential causal routes. Twenty-nine patients aged 18-30 with non-affective psychosis completed three assessments over three months of their insomnia, negative affect, and psychotic experiences. Mixed effect models allowed comparisons between hypothesis-based models (comprising insomnia as predictor, negative affect as mediator, and psychotic experiences as outcome) and oppositional models, where relationships were reversed. The results supported the hypothesised mediation model above models where negative affect was primary. Insomnia was also found to be a stronger predictor of later hallucinations than vice versa, although a bidirectional relationship was indicated between insomnia and paranoia. In conclusion, insomnia predicts persistence of psychotic experiences over time to the same or greater extent than psychotic experiences contribute to insomnia. This supports insomnia as a potential intervention target in psychosis.