Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a severe, multisystem condition that often emerges after viral infections and affects physical and cognitive function. Severely affected patients are underrepresented in research due to immobility and exertional intolerance.

This is a prospective, non-interventional observational study investigating the feasibility and tolerability of home-based diagnostics in patients with severe and very severe ME/CFS. Phase 1 includes remote identification using validated questionnaires. Phase 2 involves home visits for physiological, cognitive and biological assessments. The primary outcome is feasibility; secondary outcomes include tolerability and methodological barriers.

The study protocol was approved by the Ethics Committee of the University of Freiburg (No. 25-1031-S1). Written informed consent is obtained from all participants. Results will be disseminated via peer-reviewed publications and patient support groups.

DRKS00035231; FRKS005506.

To use best practices in pharmacoepidemiology to assess the association between new use of brain-penetrant calcium channel blockers (BP-CCBs) compared with use of non-brain-penetrant CCBs (NP-CCBs) and the incidence of neuropsychiatric outcomes.

Retrospective comparative cohort study.

Secondary data from nine claims and electronic health record databases from across the globe were used.

First use of a CCB was the index date. There were 1.2 million BP-CCB patients and 9.3 million NP-CCB patients identified across all databases, with 881 758 matched in each group.

Patients were categorised as either initiating BP-CCBs or NP-CCBs. On-treatment and intention-to-treat analyses were conducted. Large-scale propensity models were used to match cohorts and control for observed confounding. Cox models were used to analyse the time to incident neuropsychiatric disorders. Negative control outcomes were used to calibrate estimates, CIs and p values to account for residual confounding. Diagnostics were used to assess the validity of the analysis.

The time to first diagnosis of schizophrenia, schizoaffective disorder, major depressive disorder (MDD) and bipolar disorder was assessed independently. HRs compared the BP-CCB group to the NP-CCB group.

For the outcome of incident MDD in the intention-to-treat design, the meta-analytic HR (95% CI) was 1.02 (0.97, 1.08). Meta-analytic HRs for bipolar disorder (1.04 (0.96, 1.13)), schizophrenia (1.05 (0.94, 1.18)) and schizoaffective disorder (1.04 (0.87, 1.23)) showed similar null effects. The on-treatment analysis was largely consistent: MDD (1.01 (0.96, 1.06)), bipolar (1.05 (0.86, 1.27)), schizophrenia (1.09 (0.87, 1.38)) and schizoaffective (1.00 (0.71, 1.40)).

There was no evidence of an association with any of the neuropsychiatric conditions of interest between use of BP-CCB and NP-CCB. This does not rule out the potential beneficial effect of CCB formulations and doses targeted specifically for the brain rather than the cardiovascular system.

Identifying anxiety disorders in autistic youth can be challenging due to the unique presentation of anxiety symptoms in autistic youth and the difficulties youth may have reporting on their own anxiety symptoms. These challenges underscore the need for objective and reliable measures. Understanding whether autonomic activity is associated with the presence of anxiety may lead to its use as an objective anxiety assessment tool in individuals who may otherwise struggle to communicate their feelings of anxiety. Most published studies examining autonomic activity and anxiety in autistic individuals lack information regarding racial demographic information, and those that do are predominantly composed of White individuals. These findings highlight the critical need for future research that includes more diverse samples and uses consistent, ecologically valid methods to examine the relation between anxiety and autonomic activity in autistic populations. This study aims to recruit a large sample of racially diverse adolescents to evaluate whether atypical autonomic activity serves as a biomarker of anxiety in autistic and non-autistic youth. This manuscript outlines the recruitment strategies for this study protocol, providing a framework for understanding the interplay between physiological, psychological and contextual factors including self-identified race in anxiety among autistic and non-autistic adolescents.

Autistic (n=80) and non-autistic (n=80) adolescents aged 11–14 years and their caregivers will be invited to participate in the current study. Autism diagnosis will be confirmed by gold-standard assessments. All participants will complete an in-person visit assessing their child’s cognitive abilities and trait-level anxiety and mental health symptoms, learn how to wear a non-invasive heart rate band that will collect ECG and respiration data, complete a 5-minute in-lab baseline of autonomic activity and enroll in experience sampling. Next, participants will complete three 5-minute baselines of autonomic activity at home, followed by 5 days of wearing the heart rate band for 5 hours per day, overlapping with ecological momentary assessment of their mood. Primary outcome measures include trait-level parent and self-reports of anxiety, real-time self-reports of anxiety captured through ecological momentary assessment, and both baseline and in-the-moment heart rate variability.

The study protocol has been approved by the University of Maryland’s Institutional Review Board. Results will be disseminated through peer-reviewed publications and conferences. Deidentified data from participants who consent to have their data shared with other researchers will be uploaded to the National Data Archive Collection C5316.

Adolescents and young adults (AYAs) in low- and middle-income countries (LMICs) are at high risk of harmful sexual and reproductive health (SRH) practices due to limited knowledge, low availability or acceptability of modern contraceptives, gender inequality and cultural practices like child marriage. Preventive and educational interventions by lay health workers or through technological means are a cost-effective and scalable solution. Unfortunately, too little is currently known about the scope, content and conditions of the effectiveness and sustainability of these approaches and synthetic evidence on this topic is scarce. To help fill this knowledge gap and to identify where further research is needed, we will conduct a scoping review of technology-based or lay health-worker delivered preventive and educational SRH interventions targeting AYAs in LMICs. This information is valuable to both policymakers and researchers as it provides a synthesis of existing interventions, highlights best practices for their implementation and identifies potential avenues for future research.

This review will include studies on SRH preventive and educational interventions targeting AYAs aged 10–24 years in LMICs. It encompasses interventions delivered by lay health workers or via technological means, assessing various outcomes including but not limited to SRH literacy, sexual risk behaviours, pregnancies, sexually transmitted infections and gender-based violence. Key databases, including PubMed via MEDLINE and Embase, will be searched from 1 January 2000 up to 23 January 2024, using a comprehensive search strategy. Screening will be conducted using Covidence software. Data extraction will cover study details, methods, intervention strategies, outcomes and findings. A narrative synthesis will be conducted following synthesis without meta-analysis guidelines.

The scope of this scoping review is limited to publicly accessible databases that do not require prior ethical approval for access. The findings will be disseminated through peer-reviewed journal publications, as well as presentations at national and international conferences and stakeholder meetings in LMICs.

The final protocol is prospectively registered with the Open Science Framework on 7 May 2024 (osf.io/vna2z).