News Scan for Aug 14, 2020

Symptom coding for COVID-19
Coronavirus in pregnancy
China COVID vaccine data
New DRC Ebola cases
Polio outbreak in Sudan
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ICD-10 codes for common COVID-19 symptoms inaccurate, study finds

Standard, symptom-specific international disease codes lack sensitivity and have poor negative predictive value (NPV) for characteristic COVID-19 symptoms, which could skew conclusions derived from them, a cohort study published today in JAMA Network Open shows.

Researchers compared the performance of International Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) codes for fever, cough, and shortness of breath with the electronic medical records (EMRs) of 2,201 patients tested for COVID-19 infection at University of Utah Health from Mar 10 to Apr 6. ICD-10 codes are often used for data aggregation and analysis.

Medical records showed that 1,444 of the 2,201 patients (66%) had fever, while 1,930 (88%) had cough, and 1,399 (64%) had shortness of breath.

The sensitivity (ability to identify those with a condition) of ICD-10 codes for fever was 26%, specificity (ability to identify those without a condition) was 98%, positive predictive value (PPV) (likelihood that those who test positive for a disease truly have it) was 96%, and NPV (likelihood that those who test negatively truly don't have a disease) was 41%. In general, the higher the percentage for these tests, the more reliable they are, with 90% or higher considered a good score.

Sensitivity for cough was 44%, specificity was 88%, PPV was 96%, and NPV was 18%. For shortness of breath, sensitivity was 24%, specificity was 97%, PPV was 93%, and NPV was 42%. ICD-10 performance was better for hospitalized patients than for those in the outpatient setting for fever and shortness of breath but not cough.

The authors called for "meticulous data validation to feed multicenter registries built from EMRs" to generate accurate, reliable research results.

"Our findings highlight the importance of quality control in COVID-19 data aggregation, which has become increasingly important with recent high-profile journal retractions," they wrote. "As with many aspects of this pandemic, we must pay careful attention to socioeconomically vulnerable populations, including racial minorities, rural patients, and low-income patients, for whom the gap between ICD-10 coding and clinical reality could be greater."
Aug 14 JAMA Netw Open study


Review of 11,000 COVID-19 pregnancies shows generally good outcomes

A study reviewing 11,308 published cases of COVID-19 in pregnancy showed that outcomes were generally favorable, though 21% of cases that included such information showed severe or critical outcomes. The study was published yesterday in Open Forum Infectious Diseases.

Overall, mortality rates were reassuring, and neonatal disease was rare: Only 41 possible cases of neonatal infection were reported in the literature, the authors said. Ninety-eight percent of women (10,437 of 10,597) survived to delivery or hospital discharge, and 33 maternal deaths were noted.

The authors found that pregnant women were also routinely excluded from ongoing clinical trials of COVID-19 treatments. Pregnancy was an exclusion criterion for 69% (75/109) of chloroquine/hydroxychloroquine studies, 80% (28/35) of lopinavir/ritonavir trials, and 48% (44/91) of convalescent plasma studies.

"The large number of clinical trials excluding pregnant persons, despite interventions with safety data in pregnancy, is concerning," the authors concluded. "In addition to observational cohort studies, pregnancy specific adaptive clinical trials could be designed to identify safe and effective treatments."
Aug 13 Open Forum Infect Dis


China's top COVID-19 vaccine safe, triggers antibodies in phase 1/2 trials

Early data from phase 1 and 2 clinical trials of China's leading COVID-19 vaccine candidate suggest that it is safe and triggers development of antibodies against the novel coronavirus, according to a study published yesterday in JAMA.

In the phase 1 trial, 96 healthy adults 18 to 59 years old in Henan province, China, received either a 2.5-, 5-, or 10-microgram (µg) dose of the inactivated vaccine, which contains the immune-boosting adjuvant alum, or adjuvant only on days 0, 28, and 56. In the phase 2 trial, 224 participants received either 5 µg of the vaccine or adjuvant only on either days 0 and 14 or 0 and 21.

The vaccine triggered production of neutralizing antibodies 14 days after booster vaccination. In the phase 1 trial, adverse reactions in the first 7 days after vaccination in 3 participants (12.5%)  in the adjuvant-only group, 5 (20.8%) in the low-dose vaccine group, 4 (16.7%) in the medium-dose vaccine group, and 6 (25.0%) in the high-dose vaccine group.

In the phase 2 trial, among participants in the group vaccinated on days 0 and 14, 5 participants (6.0%) experienced adverse effects, while 4 (14.3%) in the group that received adjuvant only did so. Among of the group vaccinated at 0 and 21 days, 16 (19%) had adverse effects, while 5 (17%) in the adjuvant-only group did so. The most common adverse events were mild pain at the injection site and fever. No serious adverse events were observed.

Final results from the ongoing trials and a planned phase 3 trial are needed to interpret the magnitude of antibody response and determine the durability of immune response response, long-term safety profile, and whether it can protect against COVID-19, the authors noted.

The vaccine was developed by the China National Biotec Group and the Wuhan Institute of Biological Products, which also sponsored the study.
Aug 13 JAMA study


With 2 new cases, DRC Ebola outbreak grows to 86, with 36 deaths

Tests confirmed 2 more Ebola infections in the Democratic Republic of the Congo (DRC) Equateur province outbreak, raising the total to 86, the World Health Organization (WHO) African regional office said today on Twitter.

No new deaths were reported, keeping the total at 36.

At a WHO media briefing on COVID-19 yesterday, WHO Director-General Tedros Adhanom Ghebreyesus, PhD, said the DRC and its partners face significant logistical challenges in investigating and establishing response capacities in extremely remote and hard-to-access areas. The outbreak's geographic spread is vast, and some areas can be accessed only by helicopter or boat.

Tedros added that the WHO has about 100 staff on the ground who are working with the DRC health ministry, other United Nations agencies, and other groups. So far, the WHO has released $2.5 million from its contingency fund, but it needs more funding to bring the outbreak under control and end it.

The outbreak began in early June, marking the DRC's 11th involving Ebola. It is occurring in the same region as a short-lived outbreak in 2018 that affected at least 54 people, 33 of them fatally.
Aug 14 WHO African regional office tweet


Polio reemerges in Sudan, affects 5 other countries

Sudan has reported an outbreak involving circulating vaccine-derived poliovirus type 2 (cVDPV2), the first confirmed polio cases there since 2009, and five other countries reported more cVDPV2 cases, according to the Global Polio Eradication Initiative (GPEI) and the United Nations Office for the Coordination of Humanitarian Affairs (OCHA).

In Sudan, the health ministry declared an outbreak on Aug 9 after confirming two cases in South Darfur and Gedaref states. Environmental samples have also tested positive in seven other states, suggesting wide circulation in the country, OCHA said, noting that urgent vaccination is needed to target 5.2 million children in affected areas.

The GPEI report said paralysis onsets for the cases occurred on Mar 7 and Apr 1 and that a genetic analysis suggests the virus is similar to the strain circulating in Chad.

Elsewhere, Afghanistan reported 14 more cVDPV2 cases, 1 in Kabul, 5 in Laghman, and 8 in Nangahar, raising the country's total for the year to 25.

In addition to Sudan, four pther African countries reported more cVDPV2 cases. Chad confirmed 5 new cases in four provinces, raising its total for 2020 to 56 from two different outbreaks. Ivory Coast reported 6 more cases in four different provinces, putting its total at 25. The DRC noted 1 more case, involving a patient from Kwilu province, raising its 2020 number to 23. And Ethiopia reported 2 more, both in Oromiya province, putting its total for the year at 14.
Aug 13 OCHA update
Aug 13 GPEI weekly report

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