Reliability and validity of the Thai Drug Hypersensitivity Quality of Life Questionnaire: a multi-center study

Author:

Chongpison Yuda1ORCID,Rerknimitr Pawinee23,Hurst Cameron4,Mongkolpathumrat Pungjai35,Palapinyo Sirinoot6,Chularojanamontri Leena7,Srinoulprasert Yuttana8,Rerkpattanapipat Ticha9,Chanprapaph Kumutnart10,Disphanurat Wareeporn11,Chakkavittumrong Panlop12,Tovanabutra Napatra13,Srisuttiyakorn Chutika13,Sukasem Chonlaphat14,Tuchinda Papapit7,Baiardini Ilaria15,Klaewsongkram Jettanong35

Affiliation:

1. Center for Excellence in Biostatistics, Faculty of Medicine, The Skin and Allergy Research Unit, Chulalongkorn University, 1873 Rama IV Rd, Pathum Wan, Bangkok, Thailand

2. Division of Dermatology, Department of Medicine, Faculty of Medicine, The Skin and Allergy Research Unit, Chulalongkorn University, 1873 Rama IV Rd, Pathum Wan, Bangkok, Thailand

3. King Chulalongkorn Memorial Hospital, Thai Red Cross Society, 1873 Rama IV Rd, Pathum Wan, Bangkok, Thailand

4. Center for Excellence in Biostatistics, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Rd, Pathum Wan, Bangkok, Thailand

5. Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine, The Skin and Allergy Research Unit, Chulalongkorn University, 1873 Rama IV Rd, Pathum Wan, Bangkok, Thailand

6. Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University, 254 Phayathai Rd, Pathum Wan, Bangkok, Thailand

7. Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wang Lang Rd., Bangkok Noi, Bangkok, Thailand

8. Department of Immunology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wang Lang Rd., Bangkok Noi, Bangkok, Thailand

9. Division of Allergy, Immunology and Rheumatology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Ratchathewi, Bangkok, Thailand

10. Division of Dermatology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Ratchathewi, Bangkok, Thailand

11. Division of Dermatology, Department of Medicine, Faculty of Medicine, Thammasat University, 95 Moo 8 Phahonyothin Rd, Khlong Luang, Pathumthani, Thailand

12. Dermatological Division, Department of Internal Medicine, Chiang Mai University, 110 Intha-Warorot Rd Mueang Chiang Mai District, Chiang Mai, Thailand

13. Division of Dermatology, Department of Medicine, Phramongkutklao Hospital, Phramongkutklao College of Medicine, 315 Ratchawithi Rd, Ratchathewi, Bangkok, Thailand

14. Division of Pharmacogenomics and Personalized Medicine, Department of Pathology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Ratchathewi, Bangkok, Thailand

15. Department of Biomedical Science, Personalized Medicine Clinic Asthma & Allergy, Humanitas Clinical and Research Center, Humanitas University, Via Rita Levi Montalcini, 4, 20090 Pieve Emanuele Milan, Italy

Abstract

Abstract Objective To adapted the Drug Hypersensitivity Quality of Life (DrHy-Q) Questionnaire from Italian into Thai and assessed its validity and reliability. Design Prospectively recruited during January 2012–May 2017. Setting Multicenter; six Thai tertiary university hospitals. Study Participants Total of 306 patients with physician-diagnosed drug hypersensitivity. Interventions Internal consistency and test–retest reliability were evaluated among 68 participants using Cronbach’s ɑ and intra-class correlation coefficient (ICC). The validity of Thai DrHy-Q was assessed among 306 participants who completed World Health Organization Quality of Life-BREF (WHOQOL-BREF-THAI). Construct and divergent validities were assessed for Thai DrHy-Q. Known-groups validity assessing discriminating ability was conducted in Thai DrHy-Q and WHOQOL-BREF-THAI. Main outcome measures Validity; reliability; single vs. multiple drug allergy; non-severe cutaneous adverse reactions (SCAR) vs. SCAR. Results Thai DrHy-Q showed good reliability (Cronbach’s ɑ = 0.94 and ICC = 0.8). Unidimensional factor structure was established by confirmatory factor analysis (CFI&TLI = 0.999, RMSEA = 0.02). Divergent validity was confirmed by weak correlation between Thai DrHy-Q and WHOQOL-BREF-THAI domains (Pearson’s r = −0.41 to −0.19). Known-groups validity of Thai DrHy-Q was confirmed with significant difference between patients with and without life-threatening SCAR (P = 0.02) and patients with multiple implicated drug classes vs. those with one class (P < 0.01); while WHOQOL-BREF-THAI could differentiate presence of life-threatening SCAR (P < 0.01) but not multiple-drug allergy. Conclusions Thai DrHy-Q was reliable and valid in evaluating quality of life among patients with drug hypersensitivity. Thai DrHy-Q was able to discriminate serious drug allergy phenotypes from non-serious manifestations in clinical practice and capture more specific drug-hypersensitivity aspects than WHOQOL-BREF-THAI.

Funder

Rachadapisek Sompote Fund

Skin and Allergy Research Unit

Office of Higher Education Commission

Thailand Research Fund

Research Electronic Data Capture

HIV Netherlands Australia Thailand Research Collaboration

Publisher

Oxford University Press (OUP)

Subject

Public Health, Environmental and Occupational Health,Health Policy,General Medicine

Reference35 articles.

1. HLA-B(*)58:01 for allopurinol-induced cutaneous adverse drug reactions: implication for clinical interpretation in Thailand;Sukasem;Front Pharmacol,2016

2. HLA-B allele and haplotype diversity among Thai patients identified by PCR-SSOP: evidence for high risk of drug-induced hypersensitivity;Puangpetch;Front Genetics,2014

3. Sequelae in 145 patients with drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms: survey conducted by the Asian Research Committee on Severe Cutaneous Adverse Reactions (ASCAR);Kano;J Dermatol,2015

4. Severe cutaneous adverse drug reactions;Verma;Med J Armed Forces India,2013

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