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Determining the comparative pharmacodynamic equivalence of a non-invasive diagnostic test for patients with adrenal insufficiency using a randomised 2-way crossover trial: the STARLIT-3 study protocol

Por: Date · K. · Baster · K. · Caunt · S. · Cohen · J. · Debono · M. · Fearnside · J. · Laud · P. · Ross · R. J. · Taylor · R. · Elder · C. J.
Introduction

Inadequate production of the essential stress hormone, cortisol, results in adrenal insufficiency (AI), which is associated with significant morbidity and mortality. The current standard diagnostic test for AI is the Short Synacthen Test (SST), but this is both invasive and resource-intensive, involving cannulation and blood sampling. A novel formulation, Nasacthin, has been developed in which the same Active Pharmaceutical Ingredient can be delivered intranasally, with the resultant glucocorticoid levels either measured in serum, or in saliva samples to render the test non-invasive, thus creating a potentially more cost-effective test. The Salivary Test of Adrenal Response to Liquid Intranasal Tetracosactide (STARLIT-3) study aims to determine the diagnostic utility of the test in patients with AI.

Methods and analysis

STARLIT-3 is a randomised 2-way crossover trial which aims to collect data from 32 AI patients allocated to receive both Synacthen and Nasacthin in a random order across two study visits. Paired blood and saliva samples will be collected from participants at baseline, and then at 30 and 60 min after drug administration. Glucocorticoid levels in study samples will be quantified with the aim to determine whether the Nasacthin test is able to correctly diagnose patients with AI by estimating the positive percent agreement with the standard SST using serum cortisol at 30 and 60 min. Data on any reported harms and on the acceptability, usability and tolerability of the Nasacthin test will also be collected.

Ethics and dissemination

The study and subsequent amendments have been reviewed and approved by South Central—Hampshire A Research Ethics Committee. Results will be published in peer-reviewed journals and presented at national and international conferences. Plans for dissemination of results to trial participants will be developed in collaboration with patient and public involvement and engagement groups.

Trial registration number

ISRCTN26461337.

A Scoping Review on Long‐Term Care Workers' Perceptions of Robot‐Assisted Care for Older Adults in Long‐Term Care Facilities

ABSTRACT

Aims

To synthesise the current research on long-term care workers' perceptions (i.e., attitudes, concerns, and expected functions) of robot-assisted care and their perceived effects of different types of robot-assisted care for older adults in long-term care facilities.

Design

Scoping review.

Data Sources

A search was conducted in July 2024 using five databases. Articles published between 2010 and 2024 on the perceptions and/or perceived effects of robot-assisted care for older adults among frontline long-term care workers in long-term care facilities were identified. Additionally, the reference lists of the included articles were manually searched.

Methods

A five-step framework that guided the development of research questions, screening of studies, and synthesis and presentation of data was adopted. Two authors independently screened and analysed the identified articles. Conflicts were resolved through joint-discussions.

Results

Forty-one articles were included in the review. Data were narratively synthesised into three categories: expected function of care robots, perceived effects of robot-assisted care, and attitudes and concerns regarding robot-assisted care. Subcategories were identified and presented in tabular form.

Conclusion

This review shows the physical, psychological, social, and practical benefits and limitations of different types of robot-assisted care. It also contributes to understanding long-term care workers' attitudes, concerns, and expectations regarding the function of robot-assisted care.

Implications for the Profession and/or Patient Care

Having a priori discussion with long-term care workers about their expectations regarding using robot-assisted care is needed. Improvements in the design and in the digital literacy of the workers are also necessary.

Impact

This review provides an overview of the perceptions and perceived effects of different types of robot-assisted care among care workers in long-term care facilities. The findings provide practical implications and highlight areas in need of further studies.

Reporting Method

Scoping Review (PRISMA-ScR) checklist.

Patient or Public Contribution

No Patient or Public Contribution.

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