Drug Hypersensitivity Quality of Life Questionnaire: validation procedures and first results of the Portuguese version

Abstract

Background 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. Methods 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. Results 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). Conclusion 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.

Validation of the Chinese drug hypersensitivity quality of life questionnaire: Role of delabeling

“…In concordance with other validation studies, the Chinese DrHy-Q could differentiate patients with multiple and single implicated drugs [ 16 – 18 ]. This can be justified by the fact that multiple labels imply greater uncertainty and limitations in drug use, as well as worse clinical outcomes secondary to the prescription restrictions associated with such labels.…”

“…Our high Cronbach α and ICC (>0.95) evidenced the reliability of the Chinese DrHy-Q. Together with the unidimensional structure, which is consistent with the original and most other translated versions, these findings proved that the Chinese DrHy-Q is an excellent instrument for measuring a single construct using multiple aspects [ 13 , 14 , 16 – 18 ].…”

“…Our results confirmed the divergence between DrHy-Q and SF-36 as hypothesized. As widely reported, DHR exerted certain detriments poorly detectable by generic surveys, highlighting the uniqueness and significance of DrHy-Q [ 13 , 16 ]. Comparatively, we appreciated stronger associations between DrHy-Q and mental health-related SF-36 scales.…”

Tradução e validação do Questionário de Qualidade de Vida em Hipersensibilidade a Drogas (DrHy-Q) para a língua portuguesa (cultura brasileira, DrHy-Qb)

“…10 The other DrHy-Q validation studies did not specify the duration of questionnaire application. [6][7][8][9][10][11] Regarding data collection, the Thai study reported low rates of unanswered items: around 1.2% of the sample. 10 The Dutch study showed non-responses in 42% of the cases; this was expected since data collection was performed via e-mail.…”

“…6 DrHy-Q was also translated and validated to the Turkish, Dutch, Spanish, Thai, and Portuguese (Portugal) languages. [7][8][9][10][11] The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) has a Brazilian version; this is a generic health assessment instrument comprising 36 questions of easy implementation and understanding that can be applied to the general population. 12 There are no Brazilian studies assessing the QoL of patients with drug hypersensitivity, nor a validated version of the DrHy-Q in Portuguese (Brazilian culture).…”