MAGIC (maternal glucose in pregnancy) understanding the glycemic profile of pregnancy, intensive CGM glucose profiling and its relationship to fetal growth: an observational study protocol.

BACKGROUND: Continuous glucose monitoring (CGM) provides the most objective method of assessing glucose in daily life. Although there have been small, short-term physiologic studies of glucose metabolism in 'healthy' pregnant women a comprehensive, longitudinal description of changes in glucose over the course of pregnancy and how glucose dysregulation earlier in pregnancy relates to traditional third trimester screening for gestational diabetes, fetal growth and pregnancy outcomes is lacking. This study aims to characterise longitudinal changes in glycemia across gestation using CGM, in order to understand the evolution of dysglycemia and its relationship to fetal growth. METHOD/DESIGN: A multi-centre, prospective, observational, cohort study of 500 healthy pregnant women, recruited in the first trimester of pregnancy. Masked CGM will be performed for a 14-day period on five occasions across pregnancy at ~ 10-12, 18-20, 26-28, 34-36 weeks gestation and postnatally. Routinely collected anthropometric and sociodemographic information will be recorded at each visit including: weight, height, blood pressure, current medication. Age, parity, ethnicity, smoking will be recorded. Blood samples will be taken at each visit for HbA1c and a sample stored. Details on fetal growth from ultrasound scans and the OGTT results will be recorded. Maternal and neonatal outcomes will be collected. CGM glucose profiling is the exposure of interest, and will be performed using standard summary statistics, functional data analysis and glucotyping. The primary maternal outcome is clinical diagnosis of GDM. The primary neonatal outcome is large for gestational age (LGA) (> 90th centile defined by customised birthweight centile). The relationship of glucose to key secondary maternal and neonatal outcomes will be explored. DISCUSSION: This study will ascertain the relationship of maternal dysglycemia to fetal growth and outcomes. It will explore whether CGM glucose profiling can detect GDM before the OGTT; or indeed whether CGM glucose profiling may be more useful than the OGTT at detecting LGA and other perinatal outcomes. TRIAL REGISTRATION: ISRCTN 15,706,303 https://www.isrctn.com/ISRCTN15706303 Registration date: 13th March 2023.

Real-world annualized relapse rates from contemporary multiple sclerosis clinics in the UK: a retrospective multicentre cohort study.

BACKGROUND: Annualized relapse rate (ARR) is used as an outcome measure in multiple sclerosis (MS) clinical trials. Previous studies demonstrated that ARR has reduced in placebo groups between 1990 and 2012. This study aimed to estimate real-world ARRs from contemporary MS clinics in the UK, in order to improve the feasibility estimations for clinical trials and facilitate MS service planning. METHODS: A multicentre observational, retrospective study of patients with MS from 5 tertiary neuroscience centres in the UK. We included all adult patients with a diagnosis of MS that had a relapse between 01/04/2020 and 30/06/2020. RESULTS: One hundred thirteen out of 8783 patients had a relapse during the 3-month study period. Seventy-nine percent of the patients with a relapse were female, the mean age was 39 years, and the median disease duration was 4.5 years; 36% of the patients that had a relapse were on disease-modifying treatment. The ARR from all study sites was estimated at 0.05. The ARR for relapsing remitting MS (RRMS) was estimated at 0.08, while the ARR for secondary progressive MS (SPMS) was 0.01. CONCLUSIONS: We report a lower ARR compared to previously reported rates in MS.

Examiner perceptions of the MRCGP recorded consultation assessment for general practice licensing during COVID-19: cross-sectional study.

BACKGROUND: The Recorded Consultation Assessment (RCA) was developed rapidly during the COVID-19 pandemic to replace the Clinical Skills Assessment (CSA) for UK general practice licensing. Our aim was to evaluate examiner perceptions of the RCA. METHODS: We employed a cross-sectional design using a questionnaire survey of RCA examiners with attitudinal (relating to examiners thoughts and perceptions of the RCA) and free text response options. We conducted statistical descriptive and factor analysis of quantitative data with qualitative thematic analysis of free text responses. RESULTS: Overall, 182 of 260 (70%) examiners completed the questionnaire. Responders felt that consultations submitted were representative of the work of a typical GP during the pandemic and provided a good sample across the curriculum. They were also generally positive about the logistic, advisory and other support provided as well as the digital platform. Despite responders generally agreeing there was sufficient information available in video or audio consultations to judge candidates' data gathering, clinical management, and interpersonal skills, they were less confident about their ability to make judgments of candidates' performance compared with the CSA. The qualitative analysis of free text responses detailed the problems of case selection and content, explained examiners' difficulties when making judgments, and detailed the generally positive views about support, training and information technology. Responders also provided helpful recommendations for improving the assessment. CONCLUSION: The RCA was considered by examiners to be feasible and broadly acceptable, although they experienced challenges from candidate case selection, case content and judgments leading to suggested areas for improvement.

The effect of specific learning difficulties on general practice written and clinical assessments.

BACKGROUND: Substantial numbers of medical students and doctors have specific learning difficulties (SpLDs) and failure to accommodate their needs can disadvantage them academically. Evidence about how SpLDs affect performance during postgraduate general practice (GP) specialty training across the different licencing assessments is lacking. We aimed to investigate the performance of doctors with SpLDs across the range of licencing assessments. METHODS: We adopted the social model of disability as a conceptual framework arguing that problems of disability are societal and that barriers that restrict life choices for people with disabilities need to be addressed. We used a longitudinal design linking Multi-Specialty Assessment (MSRA) records from 2016 and 2017 with their Applied Knowledge Test (AKT), Clinical Skills Assessment (CSA), Recorded Consultation Assessment (RCA) and Workplace Based Assessment (WPBA) outcomes up to 2021. Multivariable logistic regression models accounting for prior attainment and demographics were used to determine the SpLD doctors' likelihood of passing licencing assessments. RESULTS: The sample included 2070 doctors, with 214 (10.34%) declaring a SpLD. Candidates declaring a SpLD were significantly less likely to pass the CSA (OR 0.43, 95% CI 0.26, 0.71, p = 0.001) but not the AKT (OR 0.96, 95% CI 0.44, 2.09, p = 0.913) or RCA (OR 0.81, 95% CI 0.35, 1.85, p = 0.615). Importantly, they were significantly more likely to have difficulties with WPBA (OR 0.28, 95% CI 0.20, 0.40, p < 0.001). When looking at licencing tests subdomains, doctors with SpLD performed significantly less well on the CSA Interpersonal Skills (B = -0.70, 95% CI -1.2, -0.19, p = 0.007) and the RCA Clinical Management Skills (B = -1.68, 95% CI -3.24, -0.13, p = 0.034). CONCLUSIONS: Candidates with SpLDs encounter difficulties in multiple domains of the licencing tests and during their training. More adjustments tailored to their needs should be put in place for the applied clinical skills tests and during their training.

Strengthening Mental Abilities with Relational Training (SMART) in multiple sclerosis (MS): study protocol for a feasibility randomised controlled trial.

BACKGROUND: Multiple sclerosis (MS) is a chronic condition of the central nervous system, affecting around 1 in every 600 people in the UK, with 130 new diagnoses every week. Cognitive difficulties are common amongst people with MS, with up to 70% experiencing deficits in higher-level brain functions-such as planning and problem-solving, attention, and memory. Cognitive deficits make it difficult for people with MS to complete everyday tasks and limit their abilities to work, socialise, and live independently. There is a clear need-and recognised research priority-for treatments that can improve cognitive functioning in people with MS. The absence of effective cognitive interventions exacerbates burdens on the services accessed by people with MS-requiring these services to manage sequelae of untreated cognitive deficits, including reduced quality of life, greater disability and dependence, and poorer adherence to disease-modifying treatments. Our planned research will fill the evidence gap through developing-and examining the feasibility of trialling-a novel online cognitive rehabilitation programme for people with MS (SMART). The SMART programme directly trains relational skills (the ability to flexibly relate concepts to one another) based on theory that these skills are critical to broader cognitive functioning. METHODS: The primary objective of this study aims to conduct a feasibility study to inform the development of a definitive trial of SMART for improving cognitive functioning in people with MS. The secondary objective is to develop the framework for a cost-effectiveness analysis alongside a definitive trial, and the exploratory objective is to assess the signal of efficacy. DISCUSSION: As a feasibility trial, outcomes are unlikely to immediately effect changes to NHS practice. However, this is a necessary step towards developing a definitive trial-and will give us a signal of efficacy, a prerequisite for progression to a definitive trial. If found to be clinically and cost-effective, the latter trial could create a step-change in MS cognitive rehabilitation-improving service delivery and optimising support with limited additional resources. TRIAL REGISTRATION: Registration ID: ClnicalTrials.gov: NCT04975685-registered on July 23rd, 2021. PROTOCOL VERSION: 2.0, 25 November 2021.

Continuous Glucose Monitoring Metrics and Birth Weight: Informing Management of Type 1 Diabetes Throughout Pregnancy.

OBJECTIVE: To determine gestational weekly changes in continuous glucose monitoring (CGM) metrics and 24-h glucose profiles and their relationship to infant birth weight in pregnant women with type 1 diabetes. RESEARCH DESIGN AND METHODS: An analysis of >10.5 million CGM glucose measures from 386 pregnant women with type 1 diabetes from two international multicenter studies was performed. CGM glucose metrics and 24-h glucose profiles were calculated for each gestational week, and the relationship to normal (10-90th percentile) and large (>90th percentile) for gestational age (LGA) birth weight infants was determined. RESULTS: Mean CGM glucose concentration fell and percentage of time spent in the pregnancy target range of 3.5-7.8 mmol/L (63-140 mg/dL) increased in the first 10 weeks of pregnancy and plateaued until 28 weeks of gestation, before further improvement in mean glucose and percentage of time in range until delivery. Maternal CGM glucose metrics diverged at 10 weeks of gestation, with significantly lower mean CGM glucose concentration (7.1 mmol/L; 95% CI 7.05-7.15 [127.8 mg/dL; 95% CI 126.9-128.7] vs. 7.5 mmol/L; 95% CI 7.45-7.55 [135 mg/dL; 95% CI 134.1-135.9]) and higher percentage of time in range (55%; 95% CI 54-56 vs. 50%; 95% CI 49-51) in women who had normal versus LGA. The 24-h glucose profiles were significantly higher across the day from 10 weeks of gestation in LGA. CONCLUSIONS: Normal birth weight is associated with achieving significantly lower mean CGM glucose concentration across the 24-h day and higher CGM time in range from before the end of the first trimester, emphasizing the need for a shift in clinical management, with increased focus on using weekly CGM glucose targets for optimizing maternal glycemia from early pregnancy.

Ambulance attendance for substance and/or alcohol use in a pandemic: Interrupted time series analysis of incidents.

INTRODUCTION: The ambulance attendance for substance and/or alcohol use in a pandemic (ASAP) study explores incidents during the COVID-19 lockdown in the East Midlands region of the United Kingdom (23 March-4 July 2020). METHOD: Retrospective cross-sectional count per day of ambulance attendances from the East Midlands Ambulance Service Trust. Ambulance attendances relating to alcohol or other drug use in the year prior, during lockdown and weeks following, were examined using interrupted time series analysis by patient demographics and geographical location. RESULTS: A total of 36 104 records were identified (53.7% male, 84.5% ethnicity classified as White, mean age 38.4 years). A significant drop in the number of attendances per day at the start of lockdown (-25.24, confidence interval - 38.16, -12.32) was observed, followed by a gradual increase during the ongoing lockdown period (0.36, confidence interval 0.23, 0.46). Similar patterns were found across genders, age groups 16-64 and urban/rural locations. DISCUSSION AND CONCLUSION: The pattern of ambulance attendances for alcohol or other drug use changed during the COVID-19 lockdown period. Lockdown significantly affected the use of ambulances for incidents involving alcohol or other drug use, impacting on health-care services. Further research into hazardous use of alcohol or other drugs during the lockdown periods is needed to inform policy, planning and public health initiatives.

The effect of slow-wave sleep and rapid eye-movement sleep interventions on glycaemic control: a systematic review and meta-analysis of randomised controlled trials.

Poor glycaemic control is found in diabetes, one of the most common, serious, non-communicable diseases worldwide. Trials suggest a relationship between glycaemic control and measures of sleep including duration and quality of sleep. Currently, the relationship between specific sleep stages (including slow-wave sleep (SWS), a sleep stage mainly found early in the night and linked to restorative functioning) and glycaemic control remains unclear. This systematic review aimed to synthesise the evidence of the effectiveness of specific sleep stage manipulation on measures of glycaemic control (insulin resistance, fasting and post-prandial glucose and insulin). Public databases (eg psychINFO, MEDLINE, Academic Search Complete, psychARTICLES, OpenDissertations, Scopus and Cochrane library) were searched for randomised controlled trials. Trials were included if they involved direct manipulation of SWS and/or rapid eye-movement sleep to explore the impact on measures of glycaemic control (insulin resistance, fasting and post-prandial glucose and insulin). Eight trials met the eligibility criteria, with four providing data for inclusion in one of the three meta-analyses. Insulin resistance was significantly higher in the SWS disruption when compared to the normal sleep condition, (p = 0.02). No significant differences were found for measures of fasting or post-prandial glucose or insulin. Risk of bias was considered low for performance bias, detection bias and incomplete outcome data, with unclear selection bias. This is an emerging area of research and this review provides preliminary findings and recommendations for future research around optimising sleep stage disruption (to further explore mechanisms) and sleep stage enhancement techniques (to explore potential interventions).

People with diabetes and ambulance staff perceptions of a booklet-based intervention for diabetic hypoglycaemia, "Hypos can strike twice": a mixed methods process evaluation.

BACKGROUND: Hypoglycaemia is a potentially serious condition, characterised by lower-than-normal blood glucose levels, common in people with diabetes (PWD). It can be prevented and self-managed if expert support, such as education on lifestyle and treatment, is provided. Our aim was to conduct a process evaluation to investigate how ambulance staff and PWD perceived the "Hypos can strike twice" booklet-based ambulance clinician intervention, including acceptability, understandability, usefulness, positive or negative effects, and facilitators or barriers to implementation. METHODS: We used an explanatory sequential design with a self-administered questionnaire study followed by interviews of people with diabetes and ambulance staff. We followed the Medical Research Council framework for process evaluations of complex interventions to guide data collection and analysis. Following descriptive analysis (PWD and staff surveys), exploratory factor analysis was conducted to identify staff questionnaire subscales and multiple regression models were fitted to identify demographic predictors of overall and subscale scores. RESULTS: 113 ambulance staff members and 46 PWD completed the survey. We conducted interviews with four ambulance staff members and five PWD who had been attended by an ambulance for a hypoglycaemic event. Based on surveys and interviews, there were positive attitudes to the intervention from both ambulance staff and PWD. Although the intervention was not always implemented, most staff members and PWD found the booklet informative, easy to read and to use or explain. PWD who completed the survey reported that receiving the booklet reminded and/or encouraged them to test their blood glucose more often, adjust their diet, and have a discussion/check up with their diabetes consultant. Interviewed PWD felt that the booklet intervention would be more valuable to less experienced patients or those who cannot manage their diabetes well. Overall, participants felt that the intervention could be beneficial, but were uncertain about whether it might help prevent a second hypoglycaemic event and/or reduce the number of repeat ambulance attendances. CONCLUSIONS: The 'Hypos may strike twice' intervention, which had demonstrable reductions in repeat attendances, was found to be feasible, acceptable to PWD and staff, prompting reported behaviour change and help-seeking from primary care. TRIAL REGISTRATION: Registered with ClinicalTrials.gov: NCT04243200 on 27 January 2020.

A systematic review and meta-analysis on the prevalence of non-malignant, organic gastrointestinal disorders misdiagnosed as irritable bowel syndrome.

Treatable gastrointestinal disorders in patients with symptoms typical for irritable bowel syndrome (IBS) may be overlooked. The prevalence of five gastrointestinal conditions-bile acid diarrhoea (BAD), carbohydrate malabsorption (CM), microscopic colitis (MC), pancreatic exocrine insufficiency (PEI) and small intestinal bacterial overgrowth (SIBO) was systematically assessed from studies including consecutive patients meeting diagnostic criteria for IBS. 4 databases were searched from 1978 to 2020. Studies were included if they evaluated the prevalence of these conditions in secondary healthcare setting. Estimated pooled rates were calculated and statistical heterogeneity between studies was evaluated using Q and I2 statistics. Seven studies (n = 597) estimated the pooled prevalence for BAD as 41% (95% CI 29-54). 17 studies (n = 5068) estimated that of MC as 3% (95% CI 2-4%). Two studies (n = 478) suggested a rate of 4.6% (range: 1.8-6.1%) for PEI. Using breath testing, 26 studies (n = 6700) and 13 studies (n = 3415) estimated the prevalence of lactose and fructose malabsorption as 54% (95% CI 44-64%) and 43% (95% CI 23-62%); 36 studies (n = 4630) and 22 studies (n = 2149) estimated that of SIBO as 49% (95% CI 40-57%) with lactulose and 19% (95% CI 13-27%) with glucose. Rates of all conditions were significantly higher than in healthy controls. A significant proportion of patients presenting to secondary care with IBS have an organic condition which may account for their symptoms. Failure to exclude such conditions will deny patients effective treatment.

Candidate perceptions of the UK Recorded Consultation Assessment: cross-sectional data linkage study.

The Recorded Consultation Assessment (RCA) was rapidly developed to replace the Clinical Skills Assessment (CSA) for UK general practice licencing during COVID-19. We aimed to evaluate candidate perceptions of the RCA and relationships with performance. We conducted a cross-sectional survey of RCA candidates with attitudinal, demographic, and free text response options, undertaking descriptive and factor analysis of quantitative data with qualitative thematic analysis of free text. Binomial regression was used to estimate associations between RCA pass, candidate characteristics and questionnaire responses.645 of 1551 (41.6%) candidates completed a questionnaire; 364 (56.4%) responders permitted linkage with performance and demographic data. Responders and non-responders were similar in exam performance, gender and declared disability but were significantly more likely to be UK graduates (UKG) or white compared with international medical (IMG) or ethnic minority graduates. Responders were positive about the digital platform and support resources. A small overall majority regarded the RCA as a fair assessment; a larger majority reported difficulty collecting, selecting, and submitting cases or felt rushed during recording.Logistic regression showed that ethnicity (white vs minority ethnic: odds ratio [OR] 2.99,95% confidence interval [CI] 1.23, 7.30, p = 0.016), training (UK vs IMG: OR 6.88, 95% CI 2.79, 16.95, p < 0.001), and English as first language (OR 5.11, 0% CI 2.08, 12.56, p < 0.001) were associated with exam success but questionnaire subscales, consultation type submitted, or extent of trainer review were not. The RCA was broadly acceptable but experiences were variable. Candidates experienced challenges and suggested areas for improvement.

Mental health of people with multiple sclerosis during the COVID-19 outbreak: A prospective cohort and cross-sectional case-control study of the UK MS Register.

BACKGROUND: People with MS (pwMS) have had higher rates of anxiety and depression than the general population before the COVID-19 pandemic, placing them at higher risk of experiencing poor psychological wellbeing during the pandemic. OBJECTIVE: To assess mental health and its social/lifestyle determinants in pwMS during the first wave of the outbreak in the United Kingdom. METHODS: This is a community-based, prospective longitudinal cohort and cross-sectional case-control online questionnaire study. It includes 2010 pwMS from the UK MS Register and 380 people without MS. RESULTS: The Hospital Anxiety and Depression Scale scores of pwMS for anxiety and depression during the outbreak did not change from the previous year. PwMS were more likely to have anxiety (using General Anxiety Disorder-7) and/or depression (using Patient Health Questionnaire-9) than controls during the outbreak (OR: 2.14, 95% CI: 1.58-2.91). PwMS felt lonelier (OR: 1.37, 95% CI: 1.04-1.80) reported worse social support (OR: 1.90, 95% CI: 1.18-3.07) and reported worsened exercise habits (OR: 1.65, 95% CI: 1.18-2.32) during the outbreak than controls. CONCLUSION: Early in the pandemic, pwMS remained at higher risk of experiencing anxiety and depression than the general population. It is important that multidisciplinary teams improve their support for the wellbeing of pwMS, who are vulnerable to the negative effects of the pandemic on their lifestyle and social support.

Impact of mass vaccination on SARS-CoV-2 infections among multiple sclerosis patients taking immunomodulatory disease-modifying therapies in England.

BACKGROUND: Contradicting assumptions have been made about the effectiveness of SARS-CoV-2 vaccines in patients with multiple sclerosis (MS) receiving immunomodulatory disease-modifying therapies (DMTs) based on the quantification of humoral and cellular immune responses. This study aimed to understand changes in the risk of SARS-CoV-2 infection among the total population of patients receiving MS DMTs in England following mass vaccination. METHODS: This is a retrospective analysis of national data collected prospectively and longitudinally. National Health Service (NHS) England and NHS Improvement (NHSE/I) hold prescribing data on all commissioned MS DMTs in England. United Kingdom Health Security Agency (UKHSA) has been collecting data on all registered SARS-CoV-2 test results, including polymerase chain reaction and rapid antigen tests. All patients receiving MS DMTs were identified using NHSE/I datasets. All patients receiving MS DMTs with SARS-CoV-2 infection (i.e., positive test) from March 2020 to August 2021 were identified by merging NHSE/I and UKHSA datasets. Similar data for the general population were captured using publicly available datasets of the United Kingdom government. The incidence rate ratios (IRR) of SARS-CoV-2 infection among patients receiving MS DMTs compared to the general population during the pre-vaccination (November 2020 to January 2021) and post-vaccination (June to August 2021) periods were calculated. RESULTS: A mean (standard deviation) of 41,208 (4,301) patients received an MS DMT in England during each month from March 2020 to August 2021. The IRR (95% confidence interval) of infection in patients taking ocrelizumab versus the general population increased from 1.13 (0.97-1.31) during the pre-vaccination period to 1.79 (1.57-2.03) during the post-vaccination period. For patients on fingolimod, it increased from 0.87 (0.73-1.02) to 1.40 (1.20-1.63) during the same periods. There were no significant changes for patients on other MS DMTs. CONCLUSION: SARS-CoV-2 vaccines offer less protection against infection to patients taking ocrelizumab or fingolimod, who have an impaired immune response to vaccines, than the general population. These findings will have implications for vaccination policies.

Alcohol and other substance use during the COVID-19 pandemic: A systematic review.

BACKGROUND: Although evidence suggests substance and alcohol use may change during the Covid-19 pandemic there has been no full review of the evidence around this. METHODS: A systematic review of all available evidence was carried out to document and interpret the frequency and severity of alcohol and other substance use during the Covid-19 pandemic and their relationship to demographic and mental health variables that may suggest further clinical implications. Peer reviewed articles in MEDLINE, Embase, PsycINFO, CINAHL complete and Sociological Abstracts were searched from December 2019 until November 2020. RESULTS: The search and screening identified 45 articles from 513 deduplicated records. The evidence suggests a mixed picture for alcohol use. Overall, there was a trend towards increased alcohol consumption. The proportion of people consuming alcohol during the pandemic ranged from 21.7% to 72.9% in general population samples. Unlike alcohol use, there was a clear trend towards increased use of other substances use during the COVID-19 pandemic. The proportion of people consuming other substances during the pandemic ranged from 3.6% to 17.5% in the general population. Mental health factors were the most common correlates or triggers for increased use of both alcohol and other substances. CONCLUSION: There is an increased need for treatment for alcohol and other substance use related problems during the pandemic. Increased targeting and evidence-based interventions will also be important in the period which follows this pandemic, to improve the quality of life for individuals and families, but also to prevent additional costs to society and health systems.

Educational and Training Interventions Aimed at Healthcare Workers in the Detection and Management of People With Mental Health Conditions in South and South-East Asia: A Systematic Review.

Background: To bridge significant mental health treatment gaps, it is essential that the healthcare workforce is able to detect and manage mental health conditions. We aim to synthesise evidence of effective educational and training interventions aimed at healthcare workers to increase their ability to detect and manage mental health conditions in South and South-East Asia. Methods: Systematic review of six electronic academic databases from January 2000 to August 2020 was performed. All primary research studies were eligible if conducted among healthcare workers in South and South-East Asia and reported education and training interventions to improve detection and management of mental health conditions. Quality of studies were assessed using Modified Cochrane Collaboration, ROBINS-I, and Mixed Methods Appraisal Tools and data synthesised by narrative synthesis. Results are reported according to Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines. A review protocol was registered with the PROSPERO database (CRD42020203955). Findings: We included 48 of 3,654 screened articles. Thirty-six reported improvements in knowledge and skills in the detection and management of mental health conditions. Training was predominantly delivered to community and primary care health workers to identify and manage common mental health disorders. Commonly used training included the World Health Organization's mhGAP guidelines (n = 9) and Cognitive Behavioural Therapy (n = 8) and were successfully tailored and delivered to healthcare workers. Digitally delivered training was found to be acceptable and effective. Only one study analysed cost effectiveness. Few targeted severe mental illnesses and upskilling mental health specialists or offered long-term follow-up or supervision. We found 21 studies were appraised as low/moderate and 19 as high/critical risk of bias. Interpretation: In low resource country settings, upskilling and capacity building of primary care and community healthcare workers can lead to better detection and management of people with mental health disorders and help reduce the treatment gap. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42020203955.

The effects of a leaflet-based intervention, 'Hypos can strike twice', on recurrent hypoglycaemic attendances by ambulance services: A non-randomised stepped wedge study.

AIMS: We aimed to investigate the effect of an intervention in which ambulance personnel provided advice supported by a booklet-'Hypos can strike twice'-issued following a hypoglycaemic event to prevent future ambulance attendances. METHODS: We used a non-randomised stepped wedge-controlled design. The intervention was introduced at different times (steps) in different areas (clusters) of operation within East Midlands Ambulance Service NHS Trust (EMAS). During the first step (T0), no clusters were exposed to the intervention, and during the last step (T3), all clusters were exposed. Data were analysed using a general linear mixed model (GLMM) and an interrupted-time series analysis (ITSA). RESULTS: The study included 4825 patients (mean age 65.42 years, SD 19.42; 2,166 females) experiencing hypoglycaemic events attended by EMAS. GLMM indicated a reduction in the number of unsuccessful attendances (i.e., attendance followed by a repeat attendance) in the final step of the intervention when compared to the first (odds ratio OR: 0.50, 95%CI: 0.33-0.76, p = 0.001). ITSA indicated a significant decrease in repeat ambulance attendances for hypoglycaemia-relative to the pre-intervention trend (p = 0.008). Furthermore, the hypoglycaemia care bundle was delivered in 66% of attendances during the intervention period, demonstrating a significant level of practice change (p < 0.001). CONCLUSION: The 'Hypos can strike twice' intervention had a positive effect on reducing numbers of repeat attendances for hypoglycaemia and in achieving the care bundle. The study supports the use of information booklets by ambulance clinicians to prevent future attendances for recurrent hypoglycaemic events.

Effects of cognitive behavioural therapy on insomnia in adults with tinnitus: Systematic review and meta-analysis of randomised controlled trials.

Insomnia is common in patients with tinnitus and negatively affects tinnitus symptoms and quality of life. This systematic review aimed to synthesise evidence of the effectiveness of cognitive behavioural therapy (CBT) based interventions on insomnia in adults with tinnitus. We conducted a comprehensive database search (MEDLINE, CINAHL, Web of Science, CENTRAL, ClinicalTrials.gov and PROSPERO) for published, unpublished and ongoing randomised controlled trials of CBT in adults with tinnitus. Five trials met the inclusion criteria for the systematic review, with four of these providing data for the meta-analysis. This demonstrated a statistically significant reduction in Insomnia Severity Index (a standard diagnostic questionnaire of insomnia used in clinical settings) following CBT (-3.28, 95% CI -4.51, -2.05, P=<0.001). There was no evidence of statistical heterogeneity (I2 = 0%). Risk of bias was considered low in all categories except blinding of participants, personnel, and/or the assessment of outcomes. Here, for the first time, we demonstrate that CBT-based interventions can significantly improve sleep in adults with tinnitus.

The predictors, barriers and facilitators to effective management of acute pain in children by emergency medical services: A systematic mixed studies review.

We aimed to identify predictors, barriers and facilitators to effective pre-hospital pain management in children. A segregated systematic mixed studies review was performed. We searched from inception to 30-June-2020: MEDLINE, CINAHL Complete, PsycINFO, EMBASE, Web of Science Core Collection and Scopus. Empirical quantitative, qualitative and multi-method studies of children under 18 years, their relatives or emergency medical service staff were eligible. Two authors independently performed screening and selection, quality assessment, data extraction and quantitative synthesis. Three authors performed thematic synthesis. Grading of Recommendations Assessment, Development and Evaluation and Confidence in the Evidence from Reviews of Qualitative Research were used to determine the confidence in cumulative evidence. From 4030 articles screened, 78 were selected for full text review, with eight quantitative and five qualitative studies included. Substantial heterogeneity precluded meta-analysis. Predictors of effective pain management included: 'child sex (male)', 'child age (younger)', 'type of pain (traumatic)' and 'analgesic administration'. Barriers and facilitators included internal (fear, clinical experience, education and training) and external (relatives and colleagues) influences on the clinician along with child factors (child's experience of event, pain assessment and management). Confidence in the cumulative evidence was deemed low. Efforts to facilitate analgesic administration should take priority, perhaps utilising the intranasal route. Further research is recommended to explore the experience of the child. Registration: PROSPERO CRD42017058960.

The Effect of Rural Residence on Cancer-Related Self-Efficacy With UK Cancer Survivors Following Treatment.

PURPOSE: To examine rural and urban differences in cancer-related self-efficacy with UK cancer survivors following treatment. METHODS: A cross-sectional postal survey with posttreatment cancer survivors in the East Midlands of England. The survey collected data on demographics and cancer-related self-efficacy using the Cancer Survivors Self-Efficacy Scale. Rural-urban residence was determined using Office for National Statistics classifications. Linear Regression models were developed using a Directed Acyclic Graph that determined confounding variables. When the model deviated from normal the outcome variable was transformed using the Box-Cox transformation. FINDINGS: Of those surveyed, 227 responded, of whom 58% were female and 45% lived in a rural area. A linear regression model showed a significant increase in cancer-related self-efficacy in cancer survivors living in rural areas compared to urban residents (0.76, 95% CI: 0.25-1.27), although the residual plot deviated from a normal distribution. A model of the effect of rural living on a Box-Cox transformed outcome variable confirmed an increased cancer-related self-efficacy score in rural regions (9.06, 95% CI: 2.97-15.14). Rural living remained significant (7.98, 95% CI: 1.78-14.19) after adjustment for the respondents' income. Similarly adjusting for deprivation led to a significant increase in cancer-related self-efficacy in rural regions (8.64, 95% CI: 2.48-14.79). CONCLUSION: This study has important implications when considering the impact of location of residence on cancer-related self-efficacy in cancer survivorship. The role of deprivation had some impact for sample respondents in both the urban and rural environment and merits further analysis.

Continuous Glucose Monitoring in Pregnancy: Importance of Analyzing Temporal Profiles to Understand Clinical Outcomes.

OBJECTIVE: To determine if temporal glucose profiles differed between 1) women who were randomized to real-time continuous glucose monitoring (RT-CGM) or self-monitored blood glucose (SMBG), 2) women who used insulin pumps or multiple daily insulin injections (MDIs), and 3) women whose infants were born large for gestational age (LGA) or not, by assessing CGM data obtained from the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT). RESEARCH DESIGN AND METHODS: Standard summary metrics and functional data analysis (FDA) were applied to CGM data from the CONCEPTT trial (RT-CGM, n = 100; SMBG, n = 100) taken at baseline and at 24- and 34-weeks' gestation. Multivariable regression analysis determined if temporal differences in 24-h glucose profiles occurred between comparators in each of the three groups. RESULTS: FDA revealed that women using RT-CGM had significantly lower glucose (0.4-0.8 mmol/L [7-14 mg/dL]) for 7 h/day (0800 h to 1200 h and 1600 h to 1900 h) compared with those with SMBG. Women using pumps had significantly higher glucose (0.4-0.9 mmol/L [7-16 mg/dL]) for 12 h/day (0300 h to 0600 h, 1300 h to 1800 h, and 2030 h to 0030 h) at 24 weeks with no difference at 34 weeks compared with MDI. Women who had an LGA infant ran a significantly higher glucose by 0.4-0.7 mmol/L (7-13 mg/dL) for 4.5 h/day at baseline, by 0.4-0.9 mmol/L (7-16 mg/dL) for 16 h/day at 24 weeks, and by 0.4-0.7 mmol/L (7-13 mg/dL) for 14 h/day at 34 weeks. CONCLUSIONS: FDA of temporal glucose profiles gives important information about differences in glucose control and its timing, which are undetectable by standard summary metrics. Women using RT-CGM were able to achieve better daytime glucose control, reducing fetal exposure to maternal glucose.