Drug hypersensitivity reactions
Conditions
Interventions
None listed
Sponsors
Department of Clinical Research, NHO Mie National Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: This study is intended for patients who meet all of the following criteria: (1) Patients with suspected drug hypersensitivity reactions (DHR) or a documented history of such reactions in their medical records (2) Patients aged 2 years or older (3) Patients who have provided written informed consent (4) Patients or their guardians who are capable of understanding and responding to a questionnaire in Japanese (5) Participants in the retest reliability evaluation (adult subgroup)
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will not be included in this study. (1) Individuals deemed unable to complete the questionnaire reliably (2) Individuals in an acute medical emergency (3) Individuals exhibiting acute severe psychiatric symptoms (4) Any other individuals deemed ineligible by the principal investigator or attending physician from a medical or ethical standpoint
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Internal consistency: The overall scale consistency will be assessed using Cronbach's alpha and McDonald's omega. Test-retest reliability: The Intraclass Correlation Coefficient (ICC) will be calculated (1-2 week interval; adult subsample, n=40). Construct validity: Confirmatory factor analysis (CFA) will be used to evaluate the goodness of fit of a one-factor, six-item model (e.g., CFI, TLI, RMSEA). Convergent/discriminant validity: Correlation coefficients (Pearson or Spearman) with SF-36 subscales (particularly the mental health and social functioning domains) will be calculated to examine conceptual relationships. | — |
Secondary
| Measure | Time frame |
|---|---|
| Known-groups validity: DrHyQ6 scores will be compared between patients with a history of a single culprit drug vs. multiple culprit drugs, and between those with a history of severe reactions vs. non-severe reactions; additionally, where clinical follow-up data are available, confirmed cases vs. excluded cases will be compared. Between-group differences in DrHyQ6 scores will be analyzed using the t-test or Mann-Whitney U test. Pediatric cases (exploratory analysis): Descriptive statistics and internal consistency will be evaluated, along with a preliminary assessment of PedsQL 4.0 scores. | — |
Countries
Japan
Contacts
Public ContactMarei Omori
NHO Mie National Hospital Department of Allergy
Outcome results
None listed