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Feasibility of the ICF CoreSets for Autism Strengths and Needs Assessment in NHS diagnostic services in England: protocol for a randomised pilot trial

Por: Day · M. · Scargill · K. · Poole · D. · Kellar · I. · Young · T. A. · Bölte · S. · Clarke · S. · Lodge · K.-M. · Woods · A. · Freeth · M.
Introduction

There are approximately 700 000 autistic people in the UK, and autism is increasingly being diagnosed in adulthood. Diagnosis on its own does not provide adequate information to plan post-diagnostic support for autistic people, and clinicians often plan support without the use of validated standardised tools which may exacerbate inequities in care. This study will evaluate a novel strengths and needs assessment, based on the WHO’s International Classification of Functioning, Disability and Health CoreSet for Autism, for use in adult diagnostic services immediately on receipt of an autism diagnosis. Potential issues, including the length of the assessment, timing of delivery and selection bias, will be explored as part of the trial process evaluation.

Methods and analysis

A two-arm, multisite, randomised pilot trial design will be used to evaluate the ICF CoreSets for Autism Strengths and Needs Assessment in three diagnostic services in England. A total of 72 newly diagnosed autistic adults will be recruited across the three sites over a 6-month period and randomised into an assessment group (strengths and needs assessment plus standard care) and a treatment as usual group (standard care only). The assessment group will receive a summary report of their strengths and needs on completion of the assessment. Both groups will complete measures of mental health and quality of life at baseline and 3 months follow-up (Patient Health Questionnaire-9, Generalised Anxiety Disorder questionnaire-7, Recovering Quality of Life questionnaire-10, EuroQoL-5D). Acceptability and feasibility will be measured for the strengths and needs assessment and for trial procedures using standardised measures, progression criteria and qualitative data from clinician focus groups and interviews with a subsample of autistic participants. The study design and procedures are being co-produced with an autistic advisor/patient and public involvement lead and with a steering group of autistic adults.

Ethics and dissemination

This study was reviewed by the East Midlands—Nottingham 2 Research Ethics Committee and was given Health Research Authority approval on 18 March 2025 (REC reference:25/EM/0041). The results will be disseminated via reports to the funder (NIHR), a peer-reviewed journal paper and academic conferences. We will email a summary report of findings to study participants and will invite participants to an information dissemination event at the end of the study. Links to reports and a lay summary will be provided on the research group’s website: https://sharl.sites.sheffield.ac.uk/home

Trial registration number

ISRCTN10283350.

Online Remote Behavioural Intervention for Tics (ORBIT-UK): protocol of a single cohort usability study

Por: Hastings · O. · Brown · B. J. · Prentice · K.-M. · Babbage · C. M. · Davies · E. B. · Kilgariff · J. · Murphy · T. · McGarry · G. · Guo · B. · Greenhalgh · C. · Hollis · C. · Hall · C. L.
Introduction

Tourette syndrome is a common, disabling childhood-onset condition. Exposure and response prevention (ERP) is an effective treatment for tics, yet access remains limited due to a shortage of trained therapists and uneven geographical distribution of services. The ORBIT trial demonstrated that internet-delivered ERP is both clinically and cost-effective, but was developed on a university research platform, not suitable for widescale roll-out. To enable adoption by the National Health Service (NHS) in England, ORBIT has been redeveloped on an NHS compliant platform. This study will evaluate the usability, acceptability and preliminary outcomes of ORBIT on the new platform within an NHS tic disorder service.

Methods and analysis

This single-cohort usability study will recruit 20 children and young people (aged 9–17) with tics and their chosen supporters (parents/carers). Participants will receive a 10-week online ERP intervention supported by trained coaches. Outcomes include uptake, adherence, system usability, satisfaction and clinical measures such as the Yale Global Tic Severity Scale, Parent Tic Questionnaire and Goal-Based Outcomes. Qualitative feedback will be collected via semi-structured exit interviews. Usability metrics and adverse events will be monitored throughout.

Ethics and dissemination

The study has received ethical approval from North West Greater Manchester Research Ethics Committee (ref: 25/NW/0107). The findings from the study will inform future NHS adoption. The results will be submitted for publication in peer-reviewed journals.

Trial registration number

ISRCTN82718960. Registered 10 July 2025. https://doi.org/10.1186/ISRCTN82718960

Association between COVID-19 vaccination status and mortality in hospitalised COVID-19 patients during the Omicron period: a retrospective cohort study in Taiwan

Por: Chang · M.-H. · Ko · S.-C. · Liao · K.-M. · Ho · C.-H.
Objectives

The Omicron variant of SARS-CoV-2 has emerged as the predominant strain of COVID-19 since 2022. Its association with prior vaccines remained under investigation.

Design

Retrospective cohort study.

Setting

Clinical data for patients, from 1 May 2022 to 31 January 2023, were extracted from the Chi-Mei Medical Center, Chiali electronic medical record databases.

Participants

Hospitalised COVID-19 patients in dedicated wards were enrolled in the study. Cases of COVID-19 reinfection and relapse were also included. Patients who did not have COVID-19, those with PCR repositivity, or those with incomplete laboratory data were excluded.

Interventions

Various doses of vaccines included primary series, additional dose and booster. The types of vaccines included ChAdOx1-S, mRNA-based vaccines and recombinant protein vaccine. The interval between the last vaccination date and the diagnosis date of COVID-19 was assessed.

Primary and secondary outcome measure

The primary outcome was all-cause mortality by day 30. The secondary outcomes were severe disease of COVID-19 and 90-day survival.

Results

Among 469 cases, the adjusted HR for 30-day mortality in vaccinated compared with unvaccinated patients was 0.831 (95% CI 0.541 to 1.277; p=0.398), indicating no statistically significant association. Age, Charlson Comorbidity Index (CCI), quick Sequential Organ Failure Assessment score and administration of dexamethasone were recognised as powerful predictors for survival in multivariable analysis. In subgroup analysis, a statistically significant association with better 30-day survival was observed among patients aged

Conclusions

Vaccination was associated with lower mortality in younger or low-CCI patients, but not in older or highly comorbid patients.

Rheumatoid Arthritis Real-world Cohort Study in China (ReALSA): protocol for a multicentre prospective, longitudinal cohort study

Por: Lin · J.-Z. · Zhu · Y. · Li · Q.-H. · Ouyang · Z.-M. · Liu · H.-J. · Zou · Y.-W. · Yang · Y. · Yang · K.-M. · Yang · L.-J. · Yang · Z.-H. · Zhang · L. · Mo · Y.-Q. · Ma · J.-D. · Dai · L.
Introduction

The burden of rheumatoid arthritis (RA) is profound, although treated with the treat-to-target strategy for RA patients according to the two most influential organisations for rheumatology worldwide. The need to timely achieve the control of disease activity for RA patients, especially for those difficult-to-treat individuals, is still unmet. Besides, the data on the diagnosis and prognosis of RA-related complications or comorbidities such as sarcopenia, cardiovascular diseases (CVD), malignancies and infections in large real-world cohorts are still limited. Therefore, the aim of this large-scale cohort study is to identify the development of clinical, biomedical, histopathological and imaging biomarkers for the diagnosis and prognosis of difficult-to-treat RA, and RA-related complications/comorbidities and to evaluate their impact on the prognosis of RA.

Methods and analysis

In this real-world multicentre prospective cohort, consecutive RA patients are planned to be recruited during 2024 and 2033 and with at least 5-year follow-up. Sociodemographic characteristics collection, clinical assessment, muscle assessment, histopathological assessment, imaging examination and biological samples collection will be performed at baseline, 1st, 3rd, 6th and 12th month during the first year and subsequently every 6 months until 5 years to repeat the assessments and collect the information of interested outcomes. The outcomes of interest include RA disease outcomes (including disease activity, functional and radiographic indicators) and RA-related complications/comorbidities (eg, sarcopenia, CVD, malignancies and specific infection).

Ethics and dissemination

Ethical approval has been approved by the Medical Ethics Committee of Sun Yat-sen Memorial Hospital, Sun Yat-sen University (ID: SYSKY-2023-1235-01); the Affiliated Panyu Central Hospital of Guangzhou Medical University (ID: PYRC-2024-214-01); and ShenShan Medical center, Memorial Hospital of Sun Yat-sen University (ID: 2024-SSKY-118-01). All study participants sign an informed consent form. Dissemination of results will occur via national and international conferences, in peer-reviewed journals, public conferences and social media.

Trial registration number

NCT06233929.

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