Prenatal Lead Exposure Risk Assessment by Vermont Maternity Care Providers

Introduction. One percent of women of childbearing age in the U.S. have blood lead levels ≥ 5 ug/dL, which are associated with maternal hypertension during pregnancy, neural tube and cardiac defects in infants, low birth weight, prematurity, and spontaneous abortion. It is unknown whether obstetrics providers in Vermont are screening their pregnant patients for lead levels and educating them on lead exposure risks. Objective. To gain an understanding of current lead screening practices in Vermont and issue recommendations for disseminating lead screening information. Methods. We developed and e-mailed a survey to practicing OB/GYN physicians, maternity care focused family medicine physicians, nurse midwives, and professional midwives. The survey assessed current screening practices for lead exposure in their pregnant patients, interest in receiving statewide guidelines, and guideline dissemination preferences. Results. Of the 41 respondents, 12% currently conduct risk assessments for lead exposure with all of their pregnant patients. Fifty four percent of maternity providers give all of their patients educational materials about lead exposure and risk of toxicity. Seventy one percent of maternity providers think that having guidelines provided by the Vermont Department of Health would encourage them to begin or continue lead exposure screening. The two preferred methods of communicating guidelines to physicians were grand rounds and email whereas non-physician providers preferred email and webinar. Discussion. The majority of pregnant patients in Vermont are not properly assessed or educated about lead risks. However, there is interest in having statewide standardized lead risk assessment guidelines, with dissemination preferences differing by provider type.https://scholarworks.uvm.edu/comphp_gallery/1248/thumbnail.jp

Digital smartphone intervention to recognise and manage early warning signs in schizophrenia to prevent relapse : the EMPOWER feasibility cluster RCT

Funding Information: Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 27. See the NIHR Journals Library website for further project information. Funding in Australia was provided by the National Health and Medical Research Council (APP1095879). Funding Information: The research reported in this issue of the journal was funded by the HTA programme as project number 13/154/04. The contractual start date was in April 2016. The draft report began editorial review in September 2019 and was accepted for publication in March 2020. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report. Funding Information: Declared competing interests of authors: Andrew I Gumley reports personal fees from the University of Manchester, the University of Exeter and the British Association for Behavioural & Cognitive Psychotherapies (BABCP) (Accrington, UK), and other interests with NHS Education for Scotland outside the submitted work. John Ainsworth reports other interests with Affigo CIC (Manchester, UK) outside the submitted work. Sandra Bucci is a director of Affigo CIC, a not-for-profit social enterprise company spun out of the University of Manchester in December 2015 to enable access to social enterprise funding and to promote ClinTouch, a symptom-monitoring app, to the NHS and public sector. Andrew Briggs reports personal fees from Bayer (Leverkusen, Germany), Merck Sharp & Dohme (Kenilworth, NJ, USA), Janssen Pharmaceutica (Beerse, Belgium), Novartis (Basel, Switzerland), SWORD Health (Porto, Portugal), Amgen Inc. (Thousand Oaks, CA, USA) and Daiichi Sankyo (Tokyo, Japan) outside the submitted work. John Farhall reports grants from the National Health and Medical Research Council (Australia) during the conduct of the study and other interests with Melbourne Health (NorthWestern Mental Health, Parkville, VIC, Australia) outside the submitted work. Shôn Lewis reports grants from the Medical Research Council, non-financial support from Affigo CIC and personal fees from XenZone plc (Manchester, UK) outside the submitted work. Cathy Mihalopoulos reports grants from National Health and Medical Research Council (Australia) during the conduct of the study. John Norrie reports grants from the University of Aberdeen and the University of Edinburgh during the conduct of the study and declares membership of the following NIHR boards: CPR Decision Making Committee (2016), HTA Commissioning Board (2010–16), HTA Commissioning Sub-Board (EOI) (2012–16), HTA Funding Boards Policy Group (2016), HTA General Board (2016–19), HTA Post-Board funding teleconference (2016–19), NIHR CTU Standing Advisory Committee (2017–present), NIHR HTA and EME Editorial Board (2014–19) and Pre-exposure Prophylaxis Impact Review Panel (2017–present). Paul French is a member of the HTA Mental Health Prioritisation Panel (2017–present). Chris Williams reports grants from NIHR during the conduct of the study (HTA 10/104/34 BEAT-IT: a randomised controlled trial comparing a behavioural activation treatment for depression in adults with learning disabilities with attention control; NIHR multicentre RCT of a group psychological intervention for postnatal depression in British mothers of South Asian Origin: RP-PG-0514-20012: Integrated therapist and online CBT for depression in primary care); other from Five Areas Ltd (Clydebank, UK) outside the submitted work; and that he has twice been president of the British Association for Behavioural & Cognitive Psychotherapies, the lead body for cognitive–bahavioural therapy in the UK. This body aims to advocate use of evidence-based delivery of cognitive–bahavioural therapy. Publisher Copyright: © Queen’s Printer and Controller of HMSO 2022.Peer reviewedPublisher PD

The plausibility of a role for mercury in the etiology of autism: a cellular perspective

Autism is defined by a behavioral set of stereotypic and repetitious behavioral patterns in combination with social and communication deficits. There is emerging evidence supporting the hypothesis that autism may result from a combination of genetic susceptibility and exposure to environmental toxins at critical moments in development. Mercury (Hg) is recognized as a ubiquitous environmental neurotoxin and there is mounting evidence linking it to neurodevelopmental disorders, including autism. Of course, the evidence is not derived from experimental trials with humans but rather from methods focusing on biomarkers of Hg damage, measurements of Hg exposure, epidemiological data, and animal studies. For ethical reasons, controlled Hg exposure in humans will never be conducted. Therefore, to properly evaluate the Hg-autism etiological hypothesis, it is essential to first establish the biological plausibility of the hypothesis. This review examines the plausibility of Hg as the primary etiological agent driving the cellular mechanisms by which Hg-induced neurotoxicity may result in the physiological attributes of autism. Key areas of focus include: (1) route and cellular mechanisms of Hg exposure in autism; (2) current research and examples of possible genetic variables that are linked to both Hg sensitivity and autism; (3) the role Hg may play as an environmental toxin fueling the oxidative stress found in autism; (4) role of mitochondrial dysfunction; and (5) possible role of Hg in abnormal neuroexcitory and excitotoxity that may play a role in the immune dysregulation found in autism. Future research directions that would assist in addressing the gaps in our knowledge are proposed

Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-Being, Engagement, and Recovery:Protocol for a Feasibility Cluster Randomized Controlled Trial Harnessing Mobile Phone Technology Blended With Peer Support

BACKGROUND: Relapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. OBJECTIVE: This study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. METHODS: We will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants' own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. RESULTS: Recruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. CONCLUSIONS: The knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, sample size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15058

Digital smartphone intervention to recognise and manage early warning signs in schizophrenia to prevent relapse: the EMPOWER feasibility cluster RCT.

BACKGROUND: Relapse is a major determinant of outcome for people with a diagnosis of schizophrenia. Early warning signs frequently precede relapse. A recent Cochrane Review found low-quality evidence to suggest a positive effect of early warning signs interventions on hospitalisation and relapse. OBJECTIVE: How feasible is a study to investigate the clinical effectiveness and cost-effectiveness of a digital intervention to recognise and promptly manage early warning signs of relapse in schizophrenia with the aim of preventing relapse? DESIGN: A multicentre, two-arm, parallel-group cluster randomised controlled trial involving eight community mental health services, with 12-month follow-up. SETTINGS: Glasgow, UK, and Melbourne, Australia. PARTICIPANTS: Service users were aged > 16 years and had a schizophrenia spectrum disorder with evidence of a relapse within the previous 2 years. Carers were eligible for inclusion if they were nominated by an eligible service user. INTERVENTIONS: The Early signs Monitoring to Prevent relapse in psychosis and prOmote Wellbeing, Engagement, and Recovery (EMPOWER) intervention was designed to enable participants to monitor changes in their well-being daily using a mobile phone, blended with peer support. Clinical triage of changes in well-being that were suggestive of early signs of relapse was enabled through an algorithm that triggered a check-in prompt that informed a relapse prevention pathway, if warranted. MAIN OUTCOME MEASURES: The main outcomes were feasibility of the trial and feasibility, acceptability and usability of the intervention, as well as safety and performance. Candidate co-primary outcomes were relapse and fear of relapse. RESULTS: We recruited 86 service users, of whom 73 were randomised (42 to EMPOWER and 31 to treatment as usual). Primary outcome data were collected for 84% of participants at 12 months. Feasibility data for people using the smartphone application (app) suggested that the app was easy to use and had a positive impact on motivations and intentions in relation to mental health. Actual app usage was high, with 91% of users who completed the baseline period meeting our a priori criterion of acceptable engagement (> 33%). The median time to discontinuation of > 33% app usage was 32 weeks (95% confidence interval 14 weeks to ∞). There were 8 out of 33 (24%) relapses in the EMPOWER arm and 13 out of 28 (46%) in the treatment-as-usual arm. Fewer participants in the EMPOWER arm had a relapse (relative risk 0.50, 95% confidence interval 0.26 to 0.98), and time to first relapse (hazard ratio 0.32, 95% confidence interval 0.14 to 0.74) was longer in the EMPOWER arm than in the treatment-as-usual group. At 12 months, EMPOWER participants were less fearful of having a relapse than those in the treatment-as-usual arm (mean difference -4.29, 95% confidence interval -7.29 to -1.28). EMPOWER was more costly and more effective, resulting in an incremental cost-effectiveness ratio of £3041. This incremental cost-effectiveness ratio would be considered cost-effective when using the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year gained. LIMITATIONS: This was a feasibility study and the outcomes detected cannot be taken as evidence of efficacy or effectiveness. CONCLUSIONS: A trial of digital technology to monitor early warning signs that blended with peer support and clinical triage to detect and prevent relapse is feasible. FUTURE WORK: A main trial with a sample size of 500 (assuming 90% power and 20% dropout) would detect a clinically meaningful reduction in relapse (relative risk 0.7) and improvement in other variables (effect sizes 0.3-0.4). TRIAL REGISTRATION: This trial is registered as ISRCTN99559262. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 27. See the NIHR Journals Library website for further project information. Funding in Australia was provided by the National Health and Medical Research Council (APP1095879)

Fear of psychotic relapse: exploring dynamic relationships with common early warning signs of relapse using electronic once-a-day self-reports

Background: Fear of relapse is an independent risk factor for future relapse events indicating its importance in clinical management and early warning signs-based relapse prevention monitoring. Methods: 25 participants who were taking part in a clinical trial of relapse prevention in schizophrenia responded to daily ecological momentary assessment prompts assessing common early warning signs of relapse and self-reported positive experiences like feeling supported by others. We conducted multilevel vector auto-regression using common symptoms assessed in early warning signs monitoring relapse prevention while controlling for positive self-reported experiences like feeling supported by others to estimate three networks (to explore concurrent, temporal and mean levels across the whole time period). Results: Reporting fear of relapse was positively associated (within the same cross-sectional time window) with hearing voices, alongside anxiety, negative affect and sleep change. Fear of relapse appeared to predict anxiety and negative affect on the next consecutive day. Experiencing fear of relapse on one day meant being more likely to also experience fear of relapse again at the next consecutive time point. However, none of the common early warning signs predicted fear of relapse within the temporal window and all observed relationships were small. Discussion: Early warning signs themselves appear poor predictors of experiencing fear of relapse but because fear of relapse predicts later anxiety and negative affect (even to a small degree) it may be a valuable intervention target within the daily life of people diagnosed with schizophrenia