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The study aimed to assess the responsiveness of FROM-16 to change and determine Minimal Important Change (MIC).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>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\u2019s criteria were used for assessing ES. The AUC\u2009\u2265\u20090.7 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).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>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\u2009=\u20091.43 (SD\u2009=\u20094.98). The mean patient EQ-5D change over 3 months\u2009=\u2009\u22120.059 (SD\u2009=\u20090.14). The responsiveness analysis showed that the FROM-16 was responsive to change (ES\u2009=\u20090.2, SRM\u2009=\u20090.3; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.01). The ES and SRM of FROM-16 change score ranged from small (ES\u2009=\u20090.2; SRM\u2009=\u20090.3) for the distribution-based method to large (ES\u2009=\u20090.8, SRM\u2009=\u20090.85) 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\u2019s disease severity change scores (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). The MIC analysis was based on data from 100 family members of 100 patients. The MIC value of 4 was suggested for FROM-16.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s41687-024-00703-1","type":"journal-article","created":{"date-parts":[[2024,3,26]],"date-time":"2024-03-26T14:01:32Z","timestamp":1711461692000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Responsiveness and minimal important change of the Family Reported Outcome Measure (FROM-16)"],"prefix":"10.1186","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8158-712X","authenticated-orcid":false,"given":"R.","family":"Shah","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2143-1646","authenticated-orcid":false,"given":"A.Y.","family":"Finlay","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4612-5699","authenticated-orcid":false,"given":"M.S.","family":"Salek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.","family":"Allen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.J.","family":"Nixon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Nixon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7433-4383","authenticated-orcid":false,"given":"K.","family":"Otwombe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4184-2023","authenticated-orcid":false,"given":"F.M.","family":"Ali","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5257-1142","authenticated-orcid":false,"given":"J.R.","family":"Ingram","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,3,26]]},"reference":[{"issue":"10","key":"703_CR1","doi-asserted-by":"publisher","first-page":"399","DOI":"10.1177\/0141076812472616","volume":"106","author":"CJ Golics","year":"2013","unstructured":"Golics CJ, Basra MKA, Finlay AY, Salek S (2013) The impact of disease on family members: a critical aspect of medical care. 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All patients and family members gave their electronic informed consent.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"RS, KO, HA, MN and SJN declared no competing interest; FMA is employed by Cardiff University: Cardiff University receives royalties from some uses of FROM-16; AYF reports personal fees from Novartis Lecture honorarium, personal fees from Medscape Podcast honorarium, personal fees from Eli Lilly Lecture honorarium, outside the submitted work; MSS and AYF are joint copyright owner of the FROM-16 for which Cardiff University receives royalties for its commercial use, and they receive a share under standard university policy. JRI receives a stipend as Editor-in-Chief of the British Journal of Dermatology and an authorship honorarium from UpToDate. He is a consultant for Abbvie, Boehringer Ingelheim, ChemoCentryx, Citryll, Novartis and UCB Pharma and has served on advisory boards for Insmed, Kymera Therapeutics and Viela Bio. He is co-copyright holder of HiSQOL, Investigator Global Assessment and Patient Global Assessment instruments for HS. His department receives income from royalties for the use of the Dermatology Life Quality Index (DLQI), Family Reported Outcome Measure (FROM-16) and related instruments.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"38"}}