Trial teams need to do everything possible to make their trial relevant to the people for whom the results are intended to apply (often patients) and those expected to apply them (often healthcare professionals).
In 2017 the UK’s National Institute for Health and Care Research (NIHR) launched the INCLUDE initiative which aims to improve trial delivery for under-served groups.
Linked to NIHR INCLUDE and launched in October 2020 the INCLUDE Ethnicity Framework, led by HSRU’s Prof Shaun Treweek, aims to encourage trial teams to think carefully about which ethnic groups should be included in their trial for its results to be widely applicable, and what challenges there may be to making this possible. Having identified potential challenges, the trial team can then consider ways to reduce those challenges. For this to work best, the Framework needs to be used at the trial design stage before funding is in place. The Ethnicity Framework is now included in funding guidance from NIHR, the Wellcome Trust, Scotland’s Chief Scientist Office (CSO), and Belgium’s Health Care Knowledge Centre (KCE).
Now, Dr Heidi Gardner (HSRU), Dr Frances Sherratt (University of Liverpool), Katie Biggs (University of Sheffield), and a team of 6 PPI Partners, have developed the INCLUDE Socioeconomic Disadvantage Framework. There is no consensus on a definition of socioeconomic status, nor does a widely accepted measure of socioeconomic status exist. There are many different factors that contribute to socioeconomic status, but in general terms, being socioeconomically disadvantaged involves living in less favourable social and economic circumstances than the majority of others in the same society. The Framework team operationalised this with the ‘3Ps’; Pockets, Prospects, and Places. The Socioeconomic Disadvantage Framework follows the same approach as the Ethnicity Framework; 4 key questions, and worksheets to give pointers to the sorts of things to think about when answering them. To find out more about the INCLUDE Socioeconomic Disadvantage Framework, access slides from the launch webinar that took place on January 24th 2023, and watch the recording via YouTube, click here.
HSRU PhD student, Azar Alexander-Sefre, is working on a project that acknowledges intersectionality and aims to bring our frameworks together. This is important because it isn’t sensible to consider factors in isolation and trial teams will quickly be overwhelmed if the number of frameworks continues to increase.