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Assess its impact on patient\u2019s 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\u2019 HRQoL.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>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\u2013retest 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The Portuguese DrHy-Q showed adequate internal consistency (Cronbach\u2019s \u0251\u2009=\u20090.938), good test\u2013retest reliability [ICC\u2009=\u20090.713 (95% CI 0.488\u20130.850] and one-dimensional structure. No significant correlation was found between the DrHy-Q and the PGWBI total scores (r\u2009=\u2009\u2212\u20090.010,<jats:italic>p<\/jats:italic>\u2009=\u20090.957). Two hundred of patients completed the study: 78.5% female; mean age\u2009=\u200944\u2009\u00b1\u200915\u00a0years. Mean DrHy-Q score was 36.8\u2009\u00b1\u200912.6. Two clinical factors significantly predict DrHy-Q total score: clinical manifestations and number of suspected drugs. Patients with anaphylaxis (\u03b2\u2009=\u200911.005; 95% CI 5.523; 16.487), urticaria\/angioedema (\u03b2\u2009=\u20097.770; 95% CI 2.600; 12.940) and other manifestations (\u03b2\u2009=\u20097.948; 95% CI 1.933; 13.962) are more likely to have higher DrHy-Q total score than patients with maculopapular exanthema. Patients with\u2009\u2265\u20092 suspected drugs are also more likely to have worse QoL (\u03b2\u2009=\u20097.927; 95% CI 3.687; 12.166).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>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\u2019 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\u2019s DrHy-QoL.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s12955-021-01749-1","type":"journal-article","created":{"date-parts":[[2021,5,10]],"date-time":"2021-05-10T08:03:56Z","timestamp":1620633836000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Drug Hypersensitivity Quality of Life Questionnaire: validation procedures and first results of the Portuguese version"],"prefix":"10.1186","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4495-5207","authenticated-orcid":false,"given":"E.","family":"Dias de Castro","sequence":"first","affiliation":[]},{"given":"J.","family":"Barbosa","sequence":"additional","affiliation":[]},{"given":"A. 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