On March 2, 2022, we held a webinar on the importance of including the caregiver perspective in real-world studies. Here, we delve into some of the ideas that were discussed.
What is a caregiver and why are we interested in their perspective?
A caregiver can be defined as a person – possibly a relative or a friend – who provides unpaid support to someone who is ill, disabled, elderly, or a child. There are estimated to be around 8.8 million informal caregivers in the UK¹. According to a recent Carers UK survey, not only has the number of caregivers increased since the start of the COVID-19 pandemic², but caregivers have been taking on increasing hours of care, often with less or no outside support. In the same survey, 55% of respondents admitted feeling overwhelmed by their caregiving duties. The contribution made by caregivers to society is not insignificant; estimates suggest that unofficial provision of care saves the economy £132 billion per year³.
Decision-makers acknowledge the importance of including caregiver evidence to help build a more complete picture of the impact of disease. In fact, caregiver outcomes are newly recognized by the National Institute for Health and Care Excellence (NICE) in their updated health technology evaluation manual4.
What are the key considerations when designing a study for caregivers?
So, how would you go about designing a study that collects caregiver data effectively, in order to understand the impact of disease beyond the patient themselves? From our experience the following should be taken into account:
- Reflect on the aims of the study, as well as the therapeutic area and potential sample size. Similar to patient-reported studies, there is no “one size fits all” approach when it comes to study design and methodology. It can be helpful to conduct a literature review to establish what has already been published in the area as well as the key concepts of importance to the caregiver population, and to confirm the need for a concept elicitation exercise.
- Include caregivers early in the study development process. This feedback enables the study design to be more closely aligned with the needs of the target population. In addition, caregiver involvement at this stage can support the development and review of participant-facing materials as well as boosting potential recruitment opportunities through communication between caregivers.
- Consider which questionnaires – whether generic, disease-specific, or bespoke – will best capture the burden of providing care for the disease area of interest. There are generally fewer questionnaires (particularly disease-specific instruments) that measure the caregiver experience as opposed to the patient experience of disease. This makes it all the more important to lay the groundwork, by establishing the topics that are most relevant to the study population.
- Take ethical issues into account: ensure that participants are aware that their responses will be kept confidential and will not be shared with the patient or caregiver, if both are taking part in the study. Consent may be required from each member of the pair for participation.
Most caregivers lead busy lives. Alongside providing practical and emotional assistance to the patient, they could be employed, have other family commitments, or have their own health problems to attend to. In our experience, caregivers are often keen to involve themselves in research and have their voices heard; regardless, it is important that participation in real-world studies should be made as easy and convenient as possible. It is for this reason that employing bring-your-own-device technology in our caregiver burden studies has been so effective, by enabling caregivers to provide data when and where they choose.
At Vitaccess, we are well-versed in designing digital real-world studies that are tailored to our study population, whether that be patients, caregivers, or both. To find out more about how we could help you to develop an insightful, real-world study of value to caregivers, get in touch at email@example.com.
By Emily Boxell & Catherine Bottomley
¹Carers UK. Juggling work and unpaid care. 2019. Available at: https://www.carersuk.org/for-professionals/policy/policy-library/juggling-work-and-unpaid-care. Accessed: March 2022.
²Carers UK. State of caring 2021: A snapshot of unpaid care in the UK. 2021. Available at: https://www.carersuk.org/images/Research/CUK_State_of_Caring_2021_report_web.pdf?_ga=2.62359909.894408454.1647362013-522700305. Accessed: March 2022.
³Carers UK and the University of Sheffield. Valuing Carers 2015: The rising value of carers’ support. 2015. Available at: https://www.sheffield.ac.uk/polopoly_fs/1.546409!/file/Valuing-Carers-2015.pdf. Accessed: March 2022.
4 National Institute for Health and Care Excellence. NICE health technology evaluations: the manual. 2022. Available at: https://www.nice.org.uk/process/pmg36/chapter/introduction-to-health-technology-evaluation. Accessed: March 2022.