Dias de Castro E, Barbosa J, Mesquita A M, Caires A, Ribeiro L, R Cernadas J, Baiardini I
Allergy and Clinical Immunology Department, Centro Hospitalar Universitário de S. João EPE, Porto, Portugal.
MedInUP- Center for Drug Discover and Innovative Medicines, Faculty of Medicine, University of Porto, Porto, Portugal.
Health Qual Life Outcomes. 2021 May 10;19(1):143. doi: 10.1186/s12955-021-01749-1.
Hypersensitivity reactions to drugs are unpredictable and can be very complex and severe, even life threatening. Assess its impact on patient's health related quality of life (HRQoL) is crucial. The Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q) is the only validated disease-specific HRQoL questionnaire. We aimed to translate and cross-cultural validate the DrHy-Q to the Portuguese population. It was also our purpose to determine the impact of drug hypersensitivity on patients' HRQoL.
The translation and cross-cultural adaptation of the DrHy-Q to Portuguese was performed according to standards. Reliability of the DrHy-Q Portuguese version was assessed in terms of internal consistency and test-retest reliability. Structural validity, divergent validity (with a generic health related QoLQ-PGWBI) and discriminant validity were also evaluated. Forty patients accepted to participate in the validation phase. The Portuguese version of the DrHy-Q was applied to 260 consecutively adult patients, studied in our Department for suspected drug hypersensitivity.
The Portuguese DrHy-Q showed adequate internal consistency (Cronbach's ɑ = 0.938), good test-retest reliability [ICC = 0.713 (95% CI 0.488-0.850] and one-dimensional structure. No significant correlation was found between the DrHy-Q and the PGWBI total scores (r = - 0.010, p = 0.957). Two hundred of patients completed the study: 78.5% female; mean age = 44 ± 15 years. Mean DrHy-Q score was 36.8 ± 12.6. Two clinical factors significantly predict DrHy-Q total score: clinical manifestations and number of suspected drugs. Patients with anaphylaxis (β = 11.005; 95% CI 5.523; 16.487), urticaria/angioedema (β = 7.770; 95% CI 2.600; 12.940) and other manifestations (β = 7.948; 95% CI 1.933; 13.962) are more likely to have higher DrHy-Q total score than patients with maculopapular exanthema. Patients with ≥ 2 suspected drugs are also more likely to have worse QoL (β = 7.927; 95% CI 3.687; 12.166).
The Portuguese version of DrHy-Q revealed adequate validity and reliability, indicating that it is appropriate to assess the impact of drug hypersensitivity on patients' HRQoL, providing data for a better comprehension and management of our patients. Moreover, our results highlight that the severity of the drug hypersensitivity reaction and the number of suspected drugs have impact on patient's DrHy-QoL.
药物过敏反应不可预测，可能非常复杂且严重，甚至危及生命。评估其对患者健康相关生活质量（HRQoL）的影响至关重要。药物过敏生活质量问卷（DrHy-Q）是唯一经过验证的特定疾病HRQoL问卷。我们旨在将DrHy-Q翻译成葡萄牙语并进行跨文化验证，同时确定药物过敏对患者HRQoL的影响。
按照标准对DrHy-Q进行葡萄牙语的翻译和跨文化改编。从内部一致性和重测信度方面评估DrHy-Q葡萄牙语版本的信度，还评估了结构效度、区分效度（与一般健康相关生活质量问卷Q-PGWBI）和判别效度。40名患者同意参与验证阶段。将DrHy-Q葡萄牙语版本应用于260名连续的成年患者，这些患者在我们科室因疑似药物过敏而接受研究。
葡萄牙语DrHy-Q显示出足够的内部一致性（Cronbach's α = 0.938）、良好的重测信度[ICC = 0.713（95%CI 0.488 - 0.850）]和单维结构。DrHy-Q与PGWBI总分之间未发现显著相关性（r = -0.010，p = 0.957）。200名患者完成了研究：女性占78.5%；平均年龄 = 44 ± 15岁。DrHy-Q平均得分为36.8 ± 12.6。两个临床因素显著预测DrHy-Q总分：临床表现和疑似药物数量。与斑丘疹患者相比，发生过敏反应（β = 11.005；95%CI 5.523；16.487）、荨麻疹/血管性水肿（β = 7.770；95%CI 2.600；12.940）和其他表现（β = 7.948；95%CI 1.933；13.962）的患者更有可能具有较高的DrHy-Q总分。疑似药物≥2种的患者也更有可能具有较差的生活质量（β = 7.927；95%CI 3.687；12.166）。
DrHy-Q葡萄牙语版本显示出足够的效度和信度，表明它适合评估药物过敏对患者HRQoL的影响，为更好地理解和管理我们的患者提供数据。此外，我们的结果强调药物过敏反应的严重程度和疑似药物数量对患者的DrHy-QoL有影响。
