Responsiveness and minimal important change of the Family Reported Outcome Measure (FROM-16)
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 Responsiven...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
SpringerOpen
2024-03-01
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| Series: | Journal of Patient-Reported Outcomes |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s41687-024-00703-1 |
| _version_ | 1797233563260682240 |
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| author | R. Shah A.Y. Finlay M.S. Salek H. Allen S.J. Nixon M. Nixon K. Otwombe F.M. Ali J.R. Ingram |
| author_facet | R. Shah A.Y. Finlay M.S. Salek H. Allen S.J. Nixon M. Nixon K. Otwombe F.M. Ali J.R. Ingram |
| author_sort | R. Shah |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-24T16:18:09Z |
| format | Article |
| id | doaj.art-e74a29f38cd14f7d9e7e0214e2ec72f7 |
| institution | Directory Open Access Journal |
| issn | 2509-8020 |
| language | English |
| last_indexed | 2024-04-24T16:18:09Z |
| publishDate | 2024-03-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | Journal of Patient-Reported Outcomes |
| spelling | doaj.art-e74a29f38cd14f7d9e7e0214e2ec72f72024-03-31T11:22:19ZengSpringerOpenJournal of Patient-Reported Outcomes2509-80202024-03-018111610.1186/s41687-024-00703-1Responsiveness and minimal important change of the Family Reported Outcome Measure (FROM-16)R. Shah0A.Y. Finlay1M.S. Salek2H. Allen3S.J. Nixon4M. Nixon5K. Otwombe6F.M. Ali7J.R. Ingram8Division of Infection and Immunity, School of Medicine, Cardiff UniversityDivision of Infection and Immunity, School of Medicine, Cardiff UniversitySchool of Life and Medical Sciences, University of HertfordshireShine CharityMultiple Sclerosis SocietyMultiple Sclerosis SocietyStatistics and Data Management Centre, Perinatal HIV Research Unit, Chris Hani Baragwanath Academic Hospital, University of the WitwatersrandDivision of Infection and Immunity, School of Medicine, Cardiff UniversityDivision of Infection and Immunity, School of Medicine, Cardiff UniversityAbstract 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.https://doi.org/10.1186/s41687-024-00703-1Sensitivity to changeResponsivenessLongitudinal validityFROM-16Change over timeMCID |
| spellingShingle | R. Shah A.Y. Finlay M.S. Salek H. Allen S.J. Nixon M. Nixon K. Otwombe F.M. Ali J.R. Ingram Responsiveness and minimal important change of the Family Reported Outcome Measure (FROM-16) Journal of Patient-Reported Outcomes Sensitivity to change Responsiveness Longitudinal validity FROM-16 Change over time MCID |
| title | Responsiveness and minimal important change of the Family Reported Outcome Measure (FROM-16) |
| title_full | Responsiveness and minimal important change of the Family Reported Outcome Measure (FROM-16) |
| title_fullStr | Responsiveness and minimal important change of the Family Reported Outcome Measure (FROM-16) |
| title_full_unstemmed | Responsiveness and minimal important change of the Family Reported Outcome Measure (FROM-16) |
| title_short | Responsiveness and minimal important change of the Family Reported Outcome Measure (FROM-16) |
| title_sort | responsiveness and minimal important change of the family reported outcome measure from 16 |
| topic | Sensitivity to change Responsiveness Longitudinal validity FROM-16 Change over time MCID |
| url | https://doi.org/10.1186/s41687-024-00703-1 |
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