PMID- 37746798 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230928 IS - 2045-7022 (Print) IS - 2045-7022 (Electronic) IS - 2045-7022 (Linking) VI - 13 IP - 9 DP - 2023 Sep TI - Sensitivity to change and minimal clinically important difference of the angioedema control test. PG - e12295 LID - 10.1002/clt2.12295 [doi] LID - e12295 AB - BACKGROUND: The Angioedema Control Test (AECT) is a patient-reported outcome measure developed and validated for the assessment of disease control in patients with recurrent angioedema. Its sensitivity to change and minimal clinically important difference (MCID) have hitherto not been established. METHODS: Patients with recurrent angioedema due to chronic spontaneous urticaria, hereditary angioedema, or acquired C1-inhibitor deficiency were repeatedly asked to complete the AECT along with the Angioedema Quality of Life Questionnaire (AE-QoL), Dermatology Life Quality Index (DLQI), and anchors for disease control and whether treatment was sufficient during routine care visits. The sensitivity to the change of the AECT was determined by correlating changes in its scores over time with changes in the applied anchors. The MCID was determined using anchor-based and distributional criterion-based approaches. RESULTS: Eighty-six cases were used for this analysis. Changes in AECT scores correlated well with AE-QoL changes (but less with changes in the DLQI) as well as other applied anchors, demonstrating its sensitivity to change. The MCID was found to be three points for improvement of angioedema control. The available number of cases with meaningful deterioration in our dataset was too low to reach a definite conclusion on the MCID for deterioration of angioedema control. CONCLUSION: The AECT is a valuable tool to assess changes in disease control in patients with recurrent angioedema over time. The lowest AECT score change that reflects a meaningful improvement of disease control to patients (MCID) is three points. CI - (c) 2023 The Authors. Clinical and Translational Allergy published by John Wiley & Sons Ltd on behalf of European Academy of Allergy and Clinical Immunology. FAU - Fijen, Laure M AU - Fijen LM AUID- ORCID: 0000-0002-0834-8138 AD - Department of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. AD - Institute of Allergology, Charite - Universitatsmedizin Berlin, corporate member of Freie Universitat Berlin and Humboldt-Universitat zu Berlin, Berlin, Germany. AD - Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany. FAU - Vera, Carolina AU - Vera C AD - Institute of Allergology, Charite - Universitatsmedizin Berlin, corporate member of Freie Universitat Berlin and Humboldt-Universitat zu Berlin, Berlin, Germany. AD - Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany. FAU - Buttgereit, Thomas AU - Buttgereit T AUID- ORCID: 0000-0002-9389-1767 AD - Institute of Allergology, Charite - Universitatsmedizin Berlin, corporate member of Freie Universitat Berlin and Humboldt-Universitat zu Berlin, Berlin, Germany. AD - Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany. FAU - Bonnekoh, Hanna AU - Bonnekoh H AUID- ORCID: 0000-0002-3567-0149 AD - Institute of Allergology, Charite - Universitatsmedizin Berlin, corporate member of Freie Universitat Berlin and Humboldt-Universitat zu Berlin, Berlin, Germany. AD - Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany. FAU - Maurer, Marcus AU - Maurer M AUID- ORCID: 0000-0002-4121-481X AD - Institute of Allergology, Charite - Universitatsmedizin Berlin, corporate member of Freie Universitat Berlin and Humboldt-Universitat zu Berlin, Berlin, Germany. AD - Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany. FAU - Magerl, Markus AU - Magerl M AD - Institute of Allergology, Charite - Universitatsmedizin Berlin, corporate member of Freie Universitat Berlin and Humboldt-Universitat zu Berlin, Berlin, Germany. AD - Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany. FAU - Weller, Karsten AU - Weller K AD - Institute of Allergology, Charite - Universitatsmedizin Berlin, corporate member of Freie Universitat Berlin and Humboldt-Universitat zu Berlin, Berlin, Germany. AD - Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany. LA - eng PT - Journal Article PL - England TA - Clin Transl Allergy JT - Clinical and translational allergy JID - 101576043 PMC - PMC10472988 OTO - NOTNLM OT - angioedema OT - disease control OT - minimal clinically important difference (MCID)7 OT - patient-reported outcome measures (PROMs) OT - sensitivity to change COIS- KW, MM and MM are advisors for Moxie. All other authors have no conflict of interest regarding this manuscript. EDAT- 2023/09/25 06:43 MHDA- 2023/09/25 06:44 PMCR- 2023/09/01 CRDT- 2023/09/25 05:33 PHST- 2023/07/20 00:00 [revised] PHST- 2023/05/26 00:00 [received] PHST- 2023/08/07 00:00 [accepted] PHST- 2023/09/25 06:44 [medline] PHST- 2023/09/25 06:43 [pubmed] PHST- 2023/09/25 05:33 [entrez] PHST- 2023/09/01 00:00 [pmc-release] AID - CLT212295 [pii] AID - 10.1002/clt2.12295 [doi] PST - ppublish SO - Clin Transl Allergy. 2023 Sep;13(9):e12295. doi: 10.1002/clt2.12295.