Measuring the impact of disease beyond the patient: Insights from the developers of the FROM-16
When someone is living with a disease, its impact often extends beyond the individual patient to their loved ones. Yet the effects on family members' quality of life is often overlooked in clinical research and care.
The Family Reported Outcome Measure (FROM-16) was developed to help capture this often-unmeasured burden. Built on interviews with 140 family members across 26 medical specialties, the questionnaire is used across a wide range of conditions.
On the 5th anniversary of our collaboration, Mapi Research Trust sat down with Cardiff University Professors Andrew Finlay and Sam Salek, two of the measure's developers, to discuss the inspiration behind the FROM-16, the challenges of developing an instrument applicable across therapeutic areas, and the importance of recognizing the family experience in healthcare research.
What first made you realize there was a need to measure the impact of disease on family members and partners, and what was missing from existing approaches at the time?
When caring for children with severe eczema, it was obvious that the parents’ lives were greatly disrupted, as well as the child’s. But there was no way to measure this parental impact and so it was often overlooked or ignored. This experience led to the creation of a questionnaire specifically designed to measure the impact of childhood eczema on the parents’ lives. This work drew attention to family issues across different skin diseases and stimulated the creation of a generic questionnaire to use across dermatology. As we realised that this family phenomenon was not confined to dermatology, our focus widened to encompass the whole of medicine. In order to encourage the medical professions to address family issues, we set about developing a generic measure that could be used across all diseases. We suggested the concept of “The Greater Patient” to underline the interdependence and shared disease experience between patient and close family members.
The FROM-16 is designed to be used across a wide range of diseases and conditions. What were the biggest challenges in creating a measure that was both broadly applicable and meaningful to families?
The biggest challenges were to ensure that the questions/statements chosen truly reflected the perspective of family members/partners and encompassed all relevant family member experiences, but were expressed in very compact and simple terms. We therefore needed to include in our initial qualitative research the experiences of family members of people with a very wide range of different diseases, covering all the major medical specialities.
Although in the creation of FROM-16 many diverse family experiences were expressed by family members, we found that there was great commonality between the responses, indicating that family members’ lives are affected in broadly similar ways, whatever the health condition of their relative. For example, question 10 “My family activities are affected” was relevant to nearly every family member interviewed.
You interviewed 140 family members across 26 medical specialties during the development of the FROM-16. What did you learn from those conversations that surprised you or changed how you thought about the impact of disease beyond the individual patient?
We were fortunate to be able to supervise an outstanding PhD student, Catherine Bottomley (nee Golics), who identified and interviewed these family members. A frequently recurring response from these family members was that this was the first time that anyone had asked them about how they were affected by their loved one’s health condition. Their accounts of how their lives had changed highlighted the importance of measuring these effects to bring this often hidden or overlooked impact into the open.
How do you hope family-reported outcome measures such as the FROM-16 will influence future clinical research and patient care?
There are opportunities for the use of FROM-16, some already coming to fruition.
In the clinic, routine use of measures such as FROM-16 can help identify family members who need additional support, including those at risk of burnout or of having adverse effects on their own health.. In the UK a regional lymphoederma service is using FROM-16 routinely to identify and respond to family member needs.
In clinical research, identifying the impact of diseases on family members can provide an evidence basis for developing clinical guidance. When evaluating new therapies, the additional use of family reported outcome measures will provide greater depth of understanding concerning the wider benefit of new interventions. Currently there are several international studies using FROM-16 as a further measure of treatment benefit.
Finally, as the FROM-16 has been mapped to EQ-5D, FROM-16 data has the potential to inform health economic analyses,
The FROM-16 has been distributed by Mapi Research Trust for several years. How has the partnership helped support access to and awareness of the measure internationally?
FROM-16 is a generic measure for use across the whole of medicine. The advantage of MAPI Research Trust having responsibility for distribution of FROM-16 is therefore the ability of anyone across medicine approaching MAPI to find the measure and have a straightforward pathway for its use. The MAPI Research Trust with its international reach could be instrumental in expanding the much needed awareness of FROM-16. The high quality ICON translation service, facilitated through Mapi Reseach Trust, gives confidence to researchers that FROM-16 results can be validly compared across countries.
What advice would you give to researchers who are considering using the FROM-16 in clinical research or routine practice?
We would encourage researchers to review the wide range of articles describing conditions for which there is already published FROM-16 data.
Major strengths of FROM-16 include its simplicity, its validated score meaning bands and the known minimum important change (MIC) value, which allow meaningful use clinically and in research.
As the academic field of family impact is still relatively young, there is great potential for novel exploration of the topic using FROM-16.
Family members may feel overlooked during consultations that focus primarily on the patient; inviting them to complete the FROM-16 can acknowledge their experiences and contribute to more holistic clinical decision-making.
Looking back, what has been most rewarding about seeing the FROM-16 used by researchers and healthcare professionals around the world?
Having a loved one with a health condition can have a huge impact on people’s lives. The most rewarding outcome of our work is the knowledge that this impact may come out of the shadows and that family members may be better supported.