Validation of FROM-16 in Pulmonary Hypertension
Research type
Research Study
Full title
A single-centre, prospective study to assess the validity and reliability of a novel quality-of-life questionnaire, the Family Reported Outcome Measure (FROM-16), in family carers or relatives of patients with pulmonary hypertension.
IRAS ID
365711
Contact name
Stephen J Wort
Contact email
Sponsor organisation
Guy’s and St Thomas’ NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Pulmonary Hypertension (PH) is a severe, chronic, and life-limiting disease that imposes a heavy burden on not just patients, but also their families and informal carers. While the importance of patient quality of life (QoL) measures in guiding clinical, organisational and policy priorities is becomingly increasingly recognised in PH, there is still no disease-specific, validated instrument for assessing quality-of-life impacts on their family and carers. Given the critical support role that family and carers play in the PH community, this neglect means that their needs remain largely unrecognised and unaddressed, compromising holistic care. There is an urgent need for a robust, validated tool to measure family QoL in this specific context.
The Family Reported Outcome Measure (FROM-16) is a 16-item generic questionnaire, and one of the first designed specifically to capture the QoL impact of chronic diseases on family members. It is brief, psychometrically reliable and has seen growing international use. The FROM-16 has also been previously mapped to EQ-5D utility values, making it valuable for driving holistic care assessments and health economic evaluations that consider the full societal burden of PH.
However, FROM-16's specific validity and utility in the UK PH population are currently unknown. Once validated, the FROM-16 will enable clinicians to identify and support 'at-risk' families, provide crucial data to inform service design, and allow the inclusion of family QoL impacts in economic evaluations, thus giving formal recognition to this overlooked aspect of PH care. This project directly addresses the health inequality faced by PH families by providing the means to measure and ultimately improve their QoL.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
26/WM/0021
Date of REC Opinion
18 Feb 2026
REC opinion
Further Information Favourable Opinion