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Article Abstract
Purpose: To estimate the positive predictive value (PPV) of case ascertainment algorithm for hypocalcemia leading to hospitalization or emergency visit in the Swedish National Patient Register among women with postmenopausal osteoporosis (PMO) treated with antiresorptive agents. This was a regulator-requested validation study to support a multidatabase postauthorisation safety study (PASS) of antiresorptive treatment.
Methods: The Swedish part of the PASS was based on data from Swedish population registries. Potential cases of hypocalcemia, identified among women with PMO, included in the PASS in 2010-2016, were defined based on non-specific International Classification of Diseases, 10th Revision (ICD-10) codes for disorders of calcium metabolism at hospitalization or emergency visit, as recorded in the Swedish Patient Register through 2018. Presence of hypocalcemia among the potential cases was confirmed using a standardized abstraction of medical charts. PPV was estimated as a measure of validity.
Results: There were 164 potential cases of hypocalcemia, of which 121 had medical charts with sufficient information available. Among these 121 cases, 19 had confirmed hypocalcemia, PPV 15.7% (95% confidence interval: 10.0 to 23.0).
Conclusion: The case-defining algorithm based on the non-specific ICD-10 codes had a low PPV. Reliance on the algorithm may bias results of epidemiologic studies relying it. Limitations include non-response and low precision of some PPV estimates.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC12413818 | PMC |
| http://dx.doi.org/10.2147/CLEP.S525181 | DOI Listing |
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