Validation of the Angioedema Control Test (AECT)-A Patient-Reported Outcome Instrument for Assessing Angioedema Control

被引:72
作者
Weller, Karsten [1 ]
Donoso, Tamara [1 ]
Magerl, Markus [1 ]
Aygoeren-Puersuen, Emel [2 ]
Staubach, Petra [3 ]
Martinez-Saguer, Inmaculada [4 ]
Hawro, Tomasz [1 ]
Altrichter, Sabine [1 ]
Krause, Karoline [1 ]
Siebenhaar, Frank [1 ]
Metz, Martin [1 ]
Zuberbier, Torsten [1 ]
Freier, Denise [1 ]
Maurer, Marcus [1 ]
机构
[1] Charite Univ Med Berlin, Allergie Ctr Charite, Dept Dermatol & Allergy, Dermatol Allergol, Berlin, Germany
[2] Goethe Univ, Univ Hosp Frankfurt, Dept Children & Adolescents, Frankfurt, Germany
[3] Univ Med Ctr Mainz, Dept Dermatol, Mainz, Germany
[4] HRZM Hemophilia Ctr Rhein Main, Morfelden Walldorf, Germany
关键词
Angioedema; Control test; Cutoff; Development; Disease control; Patient-reported outcome; Reliability; Screening; Validation; Validity; QUALITY-OF-LIFE; URTICARIA CONTROL; OMALIZUMAB; BURDEN;
D O I
10.1016/j.jaip.2020.02.038
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
BACKGROUND: Recurrent angioedema (RA) is an important clinical problem in routine care and emergency medicine. As of recently, the only validated tools to specifically assess disease status in patients with RA were diary-type activity assessments and angioedema-related quality-of-life questionnaires. Although these tools are particularly helpful in clinical studies, they were not designed to determine disease control or to guide treatment decisions. To close this gap, the Angioedema Control Test (AECT) was published recently. OBJECTIVE: To test the AECT for its validity and reliability, and to identify a cutoff value to aid treatment decisions. METHODS: Two AECT versions with a recall period of 4 weeks (AECT-4wk) and 3 months (AECT-3mo) were tested for their internal consistency and test-retest reliability, convergent and known-groups validity as well as screening accuracy in 81 patients with RA with bradykinin-mediated angioedema, mast cell mediator-mediated angioedema, or idiopathic angioedema. RESULTS: Both AECT versions showed excellent internal consistency reliability with a Cronbach alpha value of more than 0.85 and test-retest reliability with an intraclass correlation co-efficient greater than 0.9. The convergent validity of both AECT versions was high. Both tools showed strong correlations with anchors of disease control, angioedema frequency, and health -related quality of life. A stratification of AECT scores into different levels of disease control together with a receiver -operating characteristic curve analysis suggested a cutoff value of 10 or more points to identify patients with well-controlled RA versus less than 10 points to identify patients with poorly controlled disease for both AECT versions. CONCLUSIONS: The AECT is the first valid and reliable patient-reported outcome measure to assess disease control in patients with RA. (c) 2020 American Academy of Allergy, Asthma & Immunology
引用
收藏
页码:2050 / +
页数:12
相关论文
共 27 条
[11]   Angioedema quality of life questionnaire (AE-QoL)-interpretability and sensitivity to change [J].
Kulthanan, Kanokvalai ;
Chularojanamontri, Leena ;
Rujitharanawong, Chuda ;
Weerasubpong, Puncharas ;
Maurer, Marcus ;
Weller, Karsten .
HEALTH AND QUALITY OF LIFE OUTCOMES, 2019, 17 (01)
[12]   The Humanistic, Societal, and Pharmaco-economic Burden of Angioedema [J].
Longhurst, Hilary ;
Bygum, Anette .
CLINICAL REVIEWS IN ALLERGY & IMMUNOLOGY, 2016, 51 (02) :230-239
[13]   The international WAO/EAACI guideline for the management of hereditary angioedemaThe 2017 revision and update [J].
Maurer, M. ;
Magerl, M. ;
Ansotegui, I. ;
Aygoeren-Puersuen, E. ;
Betschel, S. ;
Bork, K. ;
Bowen, T. ;
Boysen, H. Balle ;
Farkas, H. ;
Grumach, A. S. ;
Hide, M. ;
Katelaris, C. ;
Lockey, R. ;
Longhurst, H. ;
Lumry, W. R. ;
Martinez-Saguer, I. ;
Moldovan, D. ;
Nast, A. ;
Pawankar, R. ;
Potter, P. ;
Riedl, M. ;
Ritchie, B. ;
Rosenwasser, L. ;
Sanchez-Borges, M. ;
Zhi, Y. ;
Zuraw, B. ;
Craig, T. .
ALLERGY, 2018, 73 (08) :1575-1596
[14]   Positive impact of omalizumab on angioedema and quality of life in patients with refractory chronic idiopathic/spontaneous urticaria: analyses according to the presence or absence of angioedema [J].
Maurer, M. ;
Sofen, H. ;
Ortiz, B. ;
Kianifard, F. ;
Gabriel, S. ;
Bernstein, J. A. .
JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, 2017, 31 (06) :1056-1063
[15]   Ligelizumab for Chronic Spontaneous Urticaria [J].
Maurer, Marcus ;
Gimenez-Arnau, Ana M. ;
Sussman, Gordon ;
Metz, Martin ;
Baker, Diane R. ;
Bauer, Andrea ;
Bernstein, Jonathan A. ;
Brehler, Randolf ;
Chu, Chia-Yu ;
Chung, Wen-Hung ;
Danilycheva, Inna ;
Grattan, Clive ;
Hebert, Jacques ;
Katelaris, Constance ;
Makris, Michael ;
Meshkova, Raisa ;
Savic, Sinisa ;
Sinclair, Rodney ;
Sitz, Karl ;
Staubach, Petra ;
Wedi, Bettina ;
Loeffler, Juergen ;
Barve, Avantika ;
Kobayashi, Kenneth ;
Hua, Eva ;
Severin, Thomas ;
Janocha, Reinhold .
NEW ENGLAND JOURNAL OF MEDICINE, 2019, 381 (14) :1321-1332
[16]   How to Approach Chronic Inducible Urticaria [J].
Maurer, Marcus ;
Fluhr, Joachim W. ;
Khan, David A. .
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE, 2018, 6 (04) :1119-1130
[17]   Development of the asthma control test: A survey for assessing asthma control [J].
Nathan, RA ;
Sorkness, CA ;
Kosinski, M ;
Schatz, M ;
Li, JT ;
Marcus, P ;
Murray, JJ ;
Pendergraft, TB .
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 2004, 113 (01) :59-65
[18]   Responsiveness and minimal important difference of the urticaria control test [J].
Ohanyan, Tatevik ;
Schoepke, Nicole ;
Bolukbasi, Bediha ;
Metz, Martin ;
Hawro, Tomasz ;
Zuberbier, Torsten ;
Peveling-Oberhag, Adriane ;
Staubach, Petra ;
Maurer, Marcus ;
Weller, Karsten .
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 2017, 140 (06) :1710-+
[19]   Development of a disease-specific quality of life questionnaire for adult patients with hereditary angioedema due to C1 inhibitor deficiency (HAE-QoL): Spanish multi-centre research project [J].
Prior, Nieves ;
Remor, Eduardo ;
Gomez-Traseira, Carmen ;
Lopez-Serrano, Concepcion ;
Cabanas, Rosario ;
Contreras, Javier ;
Campos, Angel ;
Cardona, Victoria ;
Cimbollek, Stefan ;
Gonzalez-Quevedo, Teresa ;
Guilarte, Mar ;
Fernandez de Rojas, Dolores Hernandez ;
Marcos, Carmen ;
Rubio, Maria ;
Angel Tejedor-Alonso, Miguel ;
Caballero, Teresa .
HEALTH AND QUALITY OF LIFE OUTCOMES, 2012, 10
[20]   Effect of omalizumab on angioedema in H1-antihistamine-resistant chronic spontaneous urticaria patients: results from X-ACT, a randomized controlled trial [J].
Staubach, P. ;
Metz, M. ;
Chapman-Rothe, N. ;
Sieder, C. ;
Braeutigam, M. ;
Canvin, J. ;
Maurer, M. .
ALLERGY, 2016, 71 (08) :1135-1144