A Student Pilot for a Feasibility study of the Theoretical 3S Trial
Research type
Research Study
Full title
A Student Pilot for a Feasibility study of the Theoretical 3S Trial (SPFT3S)
IRAS ID
263993
Contact name
Terry McCormack
Contact email
Sponsor organisation
University of Hull
Duration of Study in the UK
0 years, 10 months, 28 days
Research summary
Research Summary
To provide an educational project for four medical students in which they will seek the opinions of patients, general practitioners (GPs) and ethics committee (EC) members about a theoretical research project. This is not a feasibility trial but it is preliminary work that might inform a future feasibility trial. We need to find out if we can identify the patients who could take part by using routine database searches. The background theoretical study is a trial called the “Stopping Statins Study (3S)” in which people aged 75 or more without cardiovascular disease or diabetes, and who are already taking a statin, would be randomised to taking atorvastatin 20mg or placebo (a medication with no active ingredient).
Summary of Results
Emerging evidence suggests that statins are ineffective in people aged 75 or more in the absence of cardiovascular disease (CVD) or diabetes (DM).[1,2] Based on population health economics data, NICE recommends statins up to age 85.[3] In the theoretical Stop Statins Study (3S) 50% of patients would receive a placebo and evidence of harm is the endpoint.
We set out to test if such a study would be acceptable to patients, general practitioners (GPs), NHS ethics committees and to estimate the eligible population in the UK.
We carried out searches in 8 GP practices in the Hull York Medical School area for this patient population. Questionnaires were completed by 36 patients, 19 GPs and 31 ethics committees’ members. The protocol aims for recruitment were 40 patients, 20 GPs and 20 ethics committees’ members.
5 patients indicated they might have CVD or DM and were excluded. Of the remaining 31, 35% said they would take part, 36% said ‘maybe’ or ‘unsure’ and 29% would not participate. 95% of GPs agreed to their patients participating.
None of the ethics committee members disapproved of the idea. 6 had approved drug stopping trials previously. 11 had concerns regarding capacity and consent in trials involving the very elderly. The practices’ total population of 157,920 included 2,257 fulfilling the study criteria. Using census data we estimate 903,505 potential participants in the UK.
This pilot feasibility study shows that patients and GPs are willing to take part in the 3S study and ethics committee members would support it.
The study was accepted for two poster presentations at the British Geriatric Society Autumn Scientific meeting in 2020 and the abstracts were published in the journal Age and Ageing in March 2021.[4,5]References:
1. Han BH, Sutin D, Williamson JD, et al., ALLHAT Collaborative Research Group. Effect of Statin Treatment vs Usual Care on Primary Cardiovascular Prevention Among Older Adults: The ALLHAT-LLT Randomized Clinical Trial. JAMA Intern Med 2017;177:955-65. doi:10.1001/jamainternmed.2017.
2. Ramos R, Comas-Cufí M, Martí-Lluch R, et al. Statins for primary prevention of cardiovascular events and mortality in old and very old adults with and without type 2 diabetes: retrospective cohort study. BMJ 2018;362
3. Rabar S, Harker M, O’Flynn N, Wierzbicki AS, Guideline Development Group. Lipid modification and cardiovascular risk assessment for the primary and secondary prevention of cardiovascular disease: summary of updated NICE guidance. BMJ 2014;349:g4356. doi:10.1136/bmj.
4. Brown L, Foster R, Dodd M, McCormack T. A Student Pilot for a Feasibility Study of the Theoretical 3S TRIAL (SPFT3S): GP and Ethics Committee Members Questionnaire. Age and Ageing 2021 Mar 1 (Vol. 50). Oxford Univ Press
5. Foster R, Dodd M, Brown L, Awonaya K, McCormack T. A Student Pilot for a Feasibility Study of the Theoretical 3S TRIAL (SPFT3S): Patient Questionnaire and Demographics. Age and Ageing 2021 Mar 1 (Vol. 50). Oxford Univ PressREC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
19/YH/0214
Date of REC Opinion
2 Jul 2019
REC opinion
Favourable Opinion