Evidence map›Paper›PMID 38530614›Full record

ArticleJournal of patient-reported outcomes2024

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

Abstract read
In one paragraph

Article in Journal of patient-reported outcomes, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Oral Epithelial Dysplasia Information Needs Questionnaire (ODIN-Q): Responsiveness and Insights Into Patient Education.Journal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology · 2026
    Observational
  2. Article
  3. Observational
  4. Article
  5. Article
  6. Validation of the FROM-16 in family members of patients receiving advanced therapy medicinal product (ATMP).Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025
    Article
  7. Article
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

R ShahDivision of Infection and Immunity, School of Medicine, Cardiff University, Cardiff, UK. ShahR45@cardiff.ac.uk.ORCID 0000-0001-8158-712X
A Y FinlayDivision of Infection and Immunity, School of Medicine, Cardiff University, Cardiff, UK.ORCID 0000-0003-2143-1646
M S SalekSchool of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK.ORCID 0000-0002-4612-5699
H AllenShine Charity, Cardiff, UK.
S J NixonMultiple Sclerosis Society, Cardiff, UK.
M NixonMultiple Sclerosis Society, Cardiff, UK.
K OtwombeStatistics and Data Management Centre, Perinatal HIV Research Unit, Chris Hani Baragwanath Academic Hospital, University of the Witwatersrand, Johannesburg, South Africa.ORCID 0000-0002-7433-4383
F M AliDivision of Infection and Immunity, School of Medicine, Cardiff University, Cardiff, UK.ORCID 0000-0002-4184-2023
J R IngramDivision of Infection and Immunity, School of Medicine, Cardiff University, Cardiff, UK.ORCID 0000-0002-5257-1142

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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).

methodsResponsiveness 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).

resultsEighty-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.

conclusionsThe 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.

Indexed as

Patient Reported Outcome MeasuresQuality of LifeHumansSurveys and QuestionnairesUnited KingdomWalesChange over timeFROM-16Longitudinal validityMCIDMICResponsivenessSensitivity to change

Identifiers

PMID38530614
PMCPMC10965873

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.