Research Appraisals
Evidence-based critical appraisals of the latest medical research, systematically evaluated using Oxford CEBM methodology.
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The Cochrane database of systematic reviews
Views and experiences of weight management for people living with mobility-limiting conditions, intellectual disabilities or severe mental illness: a qualitative evidence synthesis
This is a protocol for a Cochrane Review (qualitative). The objectives are as follows: This qualitative evidence synthesis (QES) aims to address the question: What is known from qualitative evidence about behavioural weight management for people living with mobility-limiting conditions, intellectual disabilities, or severe mental illness? The five review objectives are as follows. To explore individuals' experiences with weight and behavioural weight-management programmes. This includes understanding how individuals living with mobility-limiting conditions, intellectual disabilities, severe mental illness and their carers experience managing their weight and how they perceive and engage with behavioural weight-management programmes, including how accessible, supportive, and relevant they find the programme elements. To identify barriers to and facilitators of managing a healthy weight and accessing behavioural weight-management programmes. Focusing on the unique obstacles encountered by each population group, we will examine issues such as physical accessibility, communication challenges, financial constraints, and gaps in tailored support that may prevent equitable participation. We will also include people's perspectives on structural and system-level barriers, as well as the influence of intersectional factors (e.g. gender and ethnicity), on the challenges of maintaining weight and accessing and benefiting from support. To understand the impact of stigma and discrimination on programme engagement and outcomes. This objective seeks to uncover how stigma related to weight, disability, or mental health influences individuals' willingness to participate, their inclusion and sense of belonging with others within the programmes, and overall programme satisfaction. It also examines the role of stigma as a potential barrier to success. To capture the perspectives of programme providers and healthcare practitioners. Gathering insights from healthcare providers and programme facilitators, this objective assesses which programme elements are considered successful and which present ongoing challenges. This includes evaluating aspects like accessibility, engagement strategies, and support mechanisms that may require improvement. To produce an inclusive piece of research through incorporating the insight of people with lived experience and professional expertise in interpreting and considering the implications of the evidence. By synthesising this qualitative evidence, the review aims to provide a comprehensive understanding of how to design and implement behavioural weight-management programmes that are more inclusive, effective, and responsive to the needs of these populations.
29 June 2026
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SPG601-associated modulation of resting-state EEG and improvement in executive function in a fragile X syndrome randomized controlled crossover study
Fragile X syndrome (FXS) is the most common inherited cause of intellectual disability and autism spectrum disorder. Despite extensive research, no targeted treatments exist for the core symptoms of FXS. SPG601 represents the first BK channel activator to enter clinical testing for FXS, designed to restore synaptic function by correcting specific ion channel dysfunction downstream of fragile X messenger ribonucleoprotein protein (FMRP) loss. We conducted a randomized, double-blind, placebo-controlled, 2-period balanced crossover study in 10 adult men with genetically confirmed full-mutation fragile X syndrome. Participants received single doses of SPG601 800 mg and placebo separated by a 1-week washout period. Given the first in FXS nature of the study, the safety and tolerability of SPG601 were evaluated as a primary outcome. Additional endpoints included resting-state EEG power spectral density analysis across predefined frequency bands and auditory-evoked gamma oscillations combined with cognitive assessments using validated instruments and clinical global impressions scales. Among EEG measurements, excessive high frequency gamma band activity has been most extensively validated as a biomarker across species in FXS and has demonstrated correlation with severity of the human FXS phenotype and therefore served as the primary neurophysiologic endpoint. SPG601 was well tolerated with a favorable safety profile. SPG601 demonstrated significant modulation of resting-state EEG power spectral density compared to placebo. Significant treatment effects were observed for gamma power (F = 5.20, p = 0.023), alpha2 power (F = 17.43, p < 0.001), and theta power (F = 7.06, p = 0.008). SPG601 also significantly modulated aperiodic EEG slope (F = 5.28, p = 0.022), indicating alterations in the broadband 1/f component reflecting excitation-inhibition balance. Cognitive improvement was observed in the NIH Toolbox Flanker Inhibitory Control and Attention Test across multiple scoring metrics (p = 0.027). No significant effects were observed on auditory-evoked gamma measures. This study provides the first clinical evidence that SPG601 produces significant neurophysiological changes in FXS, accompanied by a cognitive enhancement in executive function.
10 Apr 2026
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