Population – Who is this intervention seeking to benefit?
Are there any obvious types of patients that should feature in this application who ought to benefit from the research, ie, elderly, homeless, particular racial or cultural groups – any groups with protected characteristics or characteristics that are not protected by law – what do we know about this population.
Does this population (or groups of people) have a charity, social club, pressure group that might be useful to include in a strategic manner while developing this application. Is there the potential to include someone right from the beginning.
Does the Patient and Public Involvement (PPI) group include people with backgrounds that are relevant here – are all affected populations represented.
Example: if you are looking at those with diabetes you must acknowledge that rates are higher in those from South East Asia and seek to have representation from an organisation that supports people from South East Asia and a PPI group that includes people from South East Asia.
Intervention – Will this intervention work the same for all these patient groups?
Will you need to do some development, refinement or validation work with the intervention to make sure you have a version suitable for all the relevant populations.
If you need to validate it for different populations that will need separate sample size calculations – you may need to over sample from those key populations.
Examples – dietary interventions for diabetes will need to reflect more than one cultural perspective. Interventions which produce genetic risk scores that say they are only validated on white populations will need validating on those who are not white.
Accessing the patient group – Does access to standard care vary for these groups?
How will you ensure that you can recruit the population who need the intervention if they do not normally turn up to receive standard care.
What additional measures could you put in place to recruit from the hard-to-reach groups.
Example – consider going to social clubs and cultural centres to tell people about the study, consider local radio, social media, posters, etc. Include GP practices from areas of need. Put in extra resources where they are needed most.
Outcome measures – Consider access issues for your populations of interest
Translations, transport, child-care, parking, taxi’s, peer support to attend appointments, payments for completed questionnaires etc.
Consider relevance for your population groups, cultural issues such as barriers to uptake and who the decision makers are. Talk to the PPI group about how to get unbiased data collection of relevant outcomes.
PPI – Have you involved a diverse group of people?
Have you ensured that additional resources are available where necessary to ensure inclusivity and that opinions are sought from all those groups the clinical research seeks to benefit?
Do you need a separate PPI group from populations in which you have tried to over sample or validate the intervention – consider allowing a PPI group just for the hard to reach population if the research is all about increasing uptake from that population.
Dissemination – Will this get to the people who need it most?
Will this help level up or do the opposite? Is the PPI group involved in helping you share the results? Are you producing separate lay summaries for those populations to use on websites, or as short videos? Are you putting things on health talk online from a diverse group of individuals? If you have patient facing materials you need to make these available to all patients. How are you going to get them translated or accessed for those who need them most?