Responsiveness and minimal important change of the Family Reported Outcome Measure (FROM-16)

R Shah; A Y Finlay; M S Salek; H Allen; S J Nixon; M Nixon; K Otwombe; F M Ali; J R Ingram

doi:10.1186/s41687-024-00703-1

Responsiveness and minimal important change of the Family Reported Outcome Measure (FROM-16)

J Patient Rep Outcomes. 2024 Mar 26;8(1):38. doi: 10.1186/s41687-024-00703-1.

Authors

R Shah¹, A Y Finlay², M S Salek³, H Allen⁴, S J Nixon⁵, M Nixon⁵, K Otwombe⁶, F M Ali², J R Ingram²

Affiliations

¹ Division of Infection and Immunity, School of Medicine, Cardiff University, Cardiff, UK. ShahR45@cardiff.ac.uk.
² Division of Infection and Immunity, School of Medicine, Cardiff University, Cardiff, UK.
³ School of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK.
⁴ Shine Charity, Cardiff, UK.
⁵ Multiple Sclerosis Society, Cardiff, UK.
⁶ Statistics and Data Management Centre, Perinatal HIV Research Unit, Chris Hani Baragwanath Academic Hospital, University of the Witwatersrand, Johannesburg, South Africa.

Abstract

Background: The FROM-16 is a generic family quality of life (QoL) instrument that measures the QoL impact of patients' disease on their family members/partners. The study aimed to assess the responsiveness of FROM-16 to change and determine Minimal Important Change (MIC).

Methods: Responsiveness and MIC for FROM-16 were assessed prospectively with patients and their family members recruited from outpatient departments of the University Hospital Wales and University Hospital Llandough, Cardiff, United Kingdom. Patients completed the EQ-5D-3L and a global severity question (GSQ) online at baseline and at 3-month follow-up. Family members completed FROM-16 at baseline and a Global Rating of Change (GRC) in addition to FROM-16 at follow-up. Responsiveness was assessed using the distribution-based (effect size-ES, standardized response mean -SRM) and anchor-based (area under the receiver operating characteristics curve ROC-AUC) approaches and by testing hypotheses on expected correlation strength between FROM-16 change score and patient assessment tools (GSQ and EQ-5D). Cohen's criteria were used for assessing ES. The AUC ≥ 0.7 was considered a good measure of responsiveness. MIC was calculated using anchor-based (ROC analysis and adjusted predictive modelling) and distribution methods based on standard deviation (SD) and standard error of the measurement (SEM).

Results: Eighty-three patients with 15 different health conditions and their relatives completed baseline and follow-up questionnaires and were included in the responsiveness analysis. The mean FROM-16 change over 3 months = 1.43 (SD = 4.98). The mean patient EQ-5D change over 3 months = -0.059 (SD = 0.14). The responsiveness analysis showed that the FROM-16 was responsive to change (ES = 0.2, SRM = 0.3; p < 0.01). The ES and SRM of FROM-16 change score ranged from small (ES = 0.2; SRM = 0.3) for the distribution-based method to large (ES = 0.8, SRM = 0.85) for anchor-based methods. The AUC value was above 0.7, indicating good responsiveness. There was a significant positive correlation between the FROM-16 change scores and the patient's disease severity change scores (p < 0.001). The MIC analysis was based on data from 100 family members of 100 patients. The MIC value of 4 was suggested for FROM-16.

Conclusions: The results of this study confirm the longitudinal validity of FROM-16 which refers to the degree to which an instrument is able to measure change in the construct to be measured. The results yield a MIC value of 4 for FROM-16. These psychometric attributes of the FROM-16 instrument are useful in both clinical research as well as clinical practice.

Keywords: Change over time; FROM-16; Longitudinal validity; MCID; MIC; Responsiveness; Sensitivity to change.

MeSH terms

Humans
Patient Reported Outcome Measures*
Quality of Life*
Surveys and Questionnaires
United Kingdom
Wales