FORCE:SEE Study: Frailty and Outcomes Measures in Clinical Environments: probable Sarcopenia, geriatric Evaluation, and Events.
We are looking for sites to participate in our next study - the FORCE:SEE Study (Frailty and Outcomes Record in Clinical Environments: probable Sarcopenia, geriatric Evaluation, and Events).
This study has been funded by the British Geriatrics Society (BGS) and offers an invaluable opportunity for trainees to develop experience in research methodology. It really doesn't matter whether your site is already "research-active" or not, or how much experience you have had of research in the past. All training required to get involved in this study will be provided, and everyone involved in the study will be acknowledged on outputs arising from this study.
What is expected of each site?
We are aiming for a total recruitment of 1000 patients from 40 sites, which works out as 25 patients per site. We expect that most sites should be able to recruit all patients within three months, which is only two patients per week. However, a much longer timeframe for recruitment will remain open if necessary. We expect that trainees should be able to conduct all study recruitment and follow-up within their normal job plans, without any impact upon the clinical service. The attached summary document details what the study will involve, and information on the training that will be provided.
What approvals will we need?
The central steering group for the study are currently in the process of applying for approval from national Research Ethics Committees and the Health Research Authority. Any sites that are able to declare their interest in participating in advance will be included within the application (you don't need to do anything at this stage). Once national ethical approvals are in place, you will be provided with all documents and given guidance as to how to obtain local approvals from your Research & Development departments. Sites that declare their interest after submission will need to be added on as amendments for national ethical approval before you can obtain your local approval, so this might take longer. We realise that trainee-led studies are unusual, and some sites might be apprehensive about taking on additional studies/workload at present. For this reason, we have created a supporting cover letter (link below) that can be forwarded to staff within your department to assure them that we are not expecting redeployment of staff to conduct this study. As the study has been funded by the BGS, it will be listed on the NIHR Portfolio, which will offer additional benefits to the trust to support with recruitment.
What do I need to do now?
In order that we can identify potential sites, we really need you to complete our expression of interest form (link below) Unless you fill in this form, we won't know you're interested! We're also using this form to gather some initial information about sites that have dynamometers available, so that we know how many we need to buy, and where to send them. We don't have a lot of funds, so we want to make sure we're making best use of our funds. Given the numbers of patients we're expecting to recruit, using a dynamometer for this study shouldn't prevent it from being used in another study.
Still have questions?