Systematic reviews to inform the design of usual care comparator arms in primary care trials: methodological approaches and profiling of current research practice.
- Principal Investigator: Katrina Turner
- 1 September 2021 to 28 February 2023
- Project No: 510
- Funding round: FR1
Background
Many studies in primary care compare a new or improved treatment with what is called ‘usual care’, which is the treatment normally given for the condition. The term ‘usual care’ suggests everyone gets the same treatment, but ‘usual care’ can vary for the same illness, and between primary care practices and parts of the country.
Some researchers say that people who get ‘usual care’, as part of a research study, should have access to all the treatments normally available. However, variation in ‘usual care’ can make it hard to know if the new treatment is really better than ‘usual care’. It can also make it hard to apply the study’s results to clinical practice. Because of these problems, some researchers say that at the start of a study, researchers should state what ‘usual care’ will be. However, if what is provided as ‘usual care’ is not the same as normal practice, it can reduce how relevant a study is to everyday clinical practice.
Currently it is not clear how researchers should decide what ‘usual care’ should be. The purpose and design of ‘usual care’ has been written about, and there have been primary care studies that include ‘usual care’, but there is no guidance to help researchers define ‘usual care’. The aim of this study is to read research articles and studies discussing ‘usual care’, and to summarise what they tell us about how primary care researchers should decide what ‘usual care’ includes when designing their research.
Methods
We will read articles and descriptions of research that describe ‘usual care’, and note what should, and has, driven decisions about its content in a research study. We will summarise what we find. This summary will provide researchers with information on what they need to consider when designing ‘usual care’, and examples of how researchers have done this in different primary care studies.
This 17 month study will be supported by a patient and public involvement (PPI) group and by researchers working in different areas of primary care, e.g. GPs, dentists, pharmacists, optometrists. A member of the PPI group will also be a member of the research team.
Results
Results will be published in medical journals, presented at conferences, and highlighted in social media.
Amount awarded: £82,140