Month: September 2024

All the Pregnant Men in the EHR

Electronic health records, data warehouses, and data “lakes” are treasured resources in this modern era of model training. Various applications of precision medicine, “digital twins”, and other predictive mimicries depend on having the cleanest, most-accurate data feasible.

One of these data sets is “All of Us“, maintained by the National Institute of Health. Considering its wide use, the authors ask a very reasonable question: how accurate is the information contained within? Considering it is not possible to individually verify the vast scope of clinical information as applied to each person included in the data set, these authors choose what ought to be a fairly reliable surrogate: with what frequency do male and female persons included in the data set have sex-discordant diagnoses?

The authors term their measure the “incongruence rate”, and this reflects their findings of sex-specific diagnoses incongruent with the biological sex recorded. The authors iteratively refined their list and sample set, ultimately settling on 167 sex-specific conditions where there ought to be very little ambiguity – vastly those related to pregnancy and disorders of female genitalia.

Rather amazingly, their overall finding was an “incongruence rate” of 0.86% – meaning nearly 1 in 100 of these sex-specific diagnoses were found on a person of the incorrect biological sex. For example, out of 4,200 patients coded with a finding of testicular hypofunction, 44 (1.05%) were female. Or, out of 2,101 coded for a finding of prolapse of female genital organs, 21 (1%) were male. The authors also performed further analyses exploring whether cis- or trans- gender misidentification was affecting these findings, and actually note the incongruence rate rose to 0.96%.

Specifics regarding limitations or flaws in this approach aside, the key insight is that of widespread inaccuracies within electronic health data – and systematic approaches to diagnostic incongruence may be useful methods for data cleansing.

“Navigating electronic health record accuracy by examination of sex incongruent conditions”
https://pubmed.ncbi.nlm.nih.gov/39254529/

The End of Respiratory Season Hell?

Every year, we have our peak of respiratory viruses – traditionally influenza, respiratory syncytial virus, and their accompanying lessor demons. These are each awful, of course, in their own way from a patient- and parent-oriented standpoint, but they’re also quite awful at the population level, overburdening limited pediatric and emergency department resources. RSV, in particular, is a vicious scourge of young and vulnerable infants.

The story told here – sponsored by Sanofi – is one of nirsevimab, a monoclonal antibody protein featured last year in the NEJM. Nirsevimab is the evolution of palivizumab, previously approved and used as a multi-injection prophylaxis scheme for the highest-risk infants. The generally established advantages of nirsevimab over palivizumab are higher and longer levels of neutralizing antibodies, requiring only a single injection rather than a multi-dose course. Nirsevimab has been recommended by the Advisory Committee on Immunization Practices for infants in the U.S. since August 2023.

These data give us a wee look at what happens to a country that adopts such a practice of wide immunization with nirsevimab – Spain! These authors compare the burden of lower respiratory tract infections and bronchiolitis admissions at 15 pediatric emergency departments across 2018 to 2024, with 2023-24 being the first season where nirsevimab was in wide usage. Most regions used a strategy in which nirsevimab was provided to new births during RSV season, as well as other young infants born prior to the onset of the season. The two “COVID seasons” of 2020-21 and 2021-22 were excluded from their comparisons.

Generally speaking, the administration of nirsevimab diminished lower respiratory tract infection presentations, bronchiolitis presentations, and bronchiolitis admission by approximately 60% as compared to prior years. The overall effect of these reductions in bronchiolitis presentations had the net effect of decreasing all presentations to the ED by about 20%. I suspect virtually every emergency department and PICU out there would prefer this sort of an experience each winter.

The catch: nirsevimab costs ~USD$500 per dose. The initial ACIP cost-effectiveness evaluations were based on the assumption nirsevimab would be priced at ~$300 a dose, at which point it was considered cost-effective. Obviously, $500 is more than $300 – and thus it becomes a robust debate which infants should be offered nirsevimab with many inputs, assumptions, and remaining uncertainties. The promise is certainly out there, however, of dramatically improved respiratory virus seasons for those working in the emergency department.

“Nirsevimab and Acute Bronchiolitis Episodes in Pediatric Emergency Departments”
https://publications.aap.org/pediatrics/article/doi/10.1542/peds.2024-066584/199339/Nirsevimab-and-Acute-Bronchiolitis-Episodes-in