Positive predictive values of International Classification of Diseases, 10th revision codes for dermatologic events and hypersensitivity leading to hospitalization or emergency room visit among women with postmenopausal osteoporosis in the Danish and Swedish national patient registries

Clinical epidemiology research studies, including pharmacoepidemiologyand pharmacovigilancestudies, use routinely collected health data, such as diagnoses recorded in national health and administrative registries, to assess clinical effectiveness and safety of treatments. We estimated positive predictive values (PPVs) of International Classification of Diseases, 10th revision ( ICD-10) codes for primary diagnoses of dermatologicevents and hypersensitivity recorded at hospitalization or emergency roomvisit in the national patient registriesof Denmark and Sweden among women with postmenopausal osteoporosis (PMO).This validation study included women with PMO identified from the Danish and Swedish national patient registries(2005-2014). Medical charts of the potential cases served as the gold standard for the diagnosis confirmation and were reviewed and adjudicated by physicians.We obtained and reviewed 189 of 221 sampled medical records (86%). The overall PPV was 92.4% (95% confidence interval [CI], 85.1%-96.3%) for dermatologicevents, while the PPVs for bullous events and erythematous dermatologicevents were 52.5% (95% CI, 37.5%-67.1%) and 12.5% (95% CI, 2.2%-47.1%), respectively. The PPV was 59.0% (95% CI, 48.3%-69.0%) for hypersensitivity; however, the PPV of hypersensitivity increased to 100.0% (95% CI, 67.6%-100.0%) when restricting to diagnostic codes for anaphylaxis. The overall results did not vary by country.Among women with PMO, the PPV for any dermatologicevent recorded as the primary diagnosis at hospitalization or at an emergency roomvisit was high and acceptable for epidemiologic research in the Danish and Swedish national patient registries. The PPV was substantially lower for hypersensitivity leading to hospitalization or emergency roomvisit.