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The methods explored for determining the MID were: (1) group comparisons based on performance status; (2) 0.5 and 0.3 standard deviation and standard error of the mean. The methods examined for the MIC were patients' subjective change ratings and receiver-operating characteristics (ROC) curves, predictive modelling, standard deviation, and standard error of the mean. The EORTC QLQ-HN43 Swallowing scale was used to investigate these methods.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      From 28 hospitals in 18 countries, 503 patients participated. Correlations with the performance status were |\n                      <jats:italic>r<\/jats:italic>\n                      |&lt;\u20090.4 in 17 out of 19 scales; hence, performance status was regarded as an unsuitable anchor. The ROC approach yielded an implausible MIC and was also discarded. The remaining approaches worked well and delivered MID values ranging from 10 to 14; the MIC for deterioration ranged from 8 to 16 and the MIC for improvement from \u2212\u00a03 to \u2212\u00a014.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>For determining MIDs of the remaining scales of the EORTC QLQ-HN43, we will omit comparisons of groups based on the Karnofsky Performance Score. Other external anchors are needed instead. Distribution-based methods worked well and will be applied as a starting strategy for analyses. For the calculation of MICs, subjective change ratings, predictive modelling, and standard-deviation based approaches are suitable methods whereas ROC analyses seem to be inappropriate.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s11136-021-02939-6","type":"journal-article","created":{"date-parts":[[2021,7,16]],"date-time":"2021-07-16T15:02:35Z","timestamp":1626447755000},"page":"841-853","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Methodological approach for determining the Minimal Important Difference and Minimal Important Change scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module (EORTC QLQ-HN43) exemplified by the Swallowing 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NK reports honoraria from ONO PHARMACEUTICAL, Bristol Meyers Squibb, Merck Biopharma, Astra-Zeneca, Merck Sharp & Dohme, Eisai, Bayer and Chugai Pharmaceutical, all outside the submitted work. LL reports grants and personal fees from Astra-Zeneca, BMS, Boehringer-Ingelheim, Debiopharm International SA, Eisai, Merck-Serono, MSD, Novartis, Roche; personal fees from Bayer, Sobi, Ipsen, GSK, Doxa Pharma srl, Incyte Biosciences Italy, Amgen, Nanobiotics; grants from Celgene International, Exelicis, Hofmann-La Roche, IRX Therapeutics, Medpace, Pfizer, all outside the submitted work. HM reports grants from Cancer Research UK, during the conduct of the study; personal fees and other from Warwickshire Head Neck Clinic Ltd, personal fees from Astra-Zeneca, MSD, Sanofi Pasteur, Merck, grants from GSK Biologicals, Sanofi Pasteur, GSK PLC, Astra-Zeneca, non-financial support from Sanofi Pasteur, MSD, Merck, outside the submitted work. He is a National Institute for Health Research (NIHR) Senior Investigator. The views expressed in this article are those of the author(s) and not necessarily those of the NIHR, or the Department of Health and Social Care. MP reports personal fees from Meeting&Words, outside the submitted work. CS reports grants from Roche, Intuitive; personal fees from Pizer, Merck, MSD, Seattle Genetics, all outside the submitted work. SS reports personal fees from Lilly, Pfizer, Boehringer-Ingelheim, all outside the submitted work.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All sites obtained ethical approval in accordance with regional and national requirements. Approval Number from the principal investigator\u2019s institution: 837.281.14 (9520).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Patients were given time to consider the study and ask any questions before consenting and participating.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"All participants provided written informed consent.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}