In the age of COVID-19, decisions that affect our day-to-day lives are influenced by analyzing numbers and data. For example, the COVID-19 positivity rate (the percentage of people who test positive for the virus out of the total number tested) influence whether or not businesses may open to the public, or, if schools should offer virtual, hybrid or in-class learning. Data are critical for strategizing, planning and implementing the policies and procedures needed to respond to the crisis and keep people safe. But what happens if different organizations are using different definitions to track the same data? Now, in a commentary published online Dec. 23, 2020, in the Journal of Hospital Medicine, J. Matthew Austin, Ph.D., M.S., and Allen Kachalia, M.D., J.D., highlight how the lack of standardized definitions for many key measures needed to manage the public health response can lead to debate, confusion and politicization of pandemic data.
During the early stages of the pandemic, Austin and Kachalia, at the Johns Hopkins Armstrong Institute for Patient Safety and Quality, began to question the methods used to report the number of positive COVID-19 cases in Maryland, as cases were being reported publically by the day the test result was known -- not by the day the test was conducted. In turn, this got them thinking about how the decisions that were being made regarding how to collect and report these data could have a serious impact on how people work and live.
"This is not about a right way or a wrong way of collecting these data," says Austin, a faculty member at the Armstrong Institute and assistant professor of anesthesiology and critical care medicine at the Johns Hopkins University School of Medicine. "What we're advocating is a standardized way of collecting and analyzing data so that we can effectively manage this pandemic and future ones."
In their commentary, Austin and Kachalia propose, among other recommendations, that health care officials in the United States create a consensus task force to identify and define metrics and, over time, refine them -- based on the prevailing science and public health priorities. They believe that once metrics are standardized, public health leaders and health care organizations will be able to use the improvements in performance and outcomes to identify which strategies are best suited for future public health planning and actions.
Michael E. Newman,
According to recent research studies, patients hospitalized with COVID-19 are at high risk of developing venous thromboembolism (VTE), a potentially deadly condition in which a blood clot forms in the deep veins of the leg, groin or arm (known as a deep vein thrombosis, or DVT) and may dislodge. If that happens, the clot can travel via the bloodstream to lodge in the lungs and cause tissue damage or death from reduced oxygen (known as a pulmonary embolism, or PE). It has recently been thought that missed doses of anti-clotting drugs in patients with COVID-19 in hospital settings might contribute to increased rates of hospital-associated VTEs.
Now, a Johns Hopkins Medicine research team has provided evidence that the high hospital-associated VTE incident rate among patients with COVID-19 is not due to clot-preventing medications -- primarily anticoagulants (commonly called "blood thinners") -- being missed or not prescribed at all during treatment, as previously suspected. The findings were reported online Jan. 28, 2021, in the Journal of Thrombosis and Thrombolysis.
In their retrospective study, the researchers looked at medical records for all 5,790 adult patients discharged from The Johns Hopkins Hospital between March 1 and May 12, 2020 -- including those who tested positively (439) or negatively (2,316) for COVID-19, or weren't tested at all (3,035). They compared the three groups for demographics, clinical characteristics, VTE outcomes, and the prescription and administration of VTE-preventive medications.
"While nonadministration of VTE prophylaxis in hospitals is known to be common, it wasn't the case for the patients with COVID-19 that we studied," says Elliott Haut, M.D., Ph.D., associate professor of surgery at the Johns Hopkins University School of Medicine and senior author of the study. "In fact, patients with COVID-19 were more frequently administered all doses of the preventive medications prescribed for them."
Haut says that the team suspects this finding reflects enhanced vigilance and prioritization by physicians (for prescribing) and nurses (for administering), due to the evidence that patients with COVID-19 have a higher risk for VTEs.
"Awareness of the high VTE risk in patients with COVID-19 has resulted in better administration of pharmacologic prophylaxis for these patients," says Mujan Varasteh Kia, M.P.H., a research assistant at the Johns Hopkins University School of Medicine and study lead author.
Before the study, Haut says the research team hypothesized that decreased patient contact and limited supplies of personal protective equipment during the early stages of the COVID-19 pandemic might have hindered the administration of VTE prophylaxis in patients with the disease. Had the study shown that to be true, Haut explains, educating health care staff to avoid missing doses would have been a relatively simple solution.
"However, we actually learned from our study that doctors and nurses are probably doing a good job of trying to prevent VTEs in patients with COVID-19 through drug intervention," Haut says. "We believe therefore, that future research efforts should prioritize finding and implementing alternative approaches to optimizing VTE prevention in these patients."
Haut and Varasteh Kia are available for interviews.
Michael E. Newman,
Johns Hopkins Medicine researchers have shown that it is possible for solid organ transplant recipients who contract COVID-19 to experience a natural immune response to SARS-CoV-2, the virus that causes the disease. In their study, published online Jan. 19, 2021, in the journal Transplantation, the researchers also suggest that measures used to provide short-term immunity against SARS-CoV-2 -- such as convalescent plasma (which contains antibodies from patients who have recovered from COVID-19) -- may actually reduce the natural response.
"We followed 18 transplant recipients who were taking immunosuppressive medications to prevent rejection and who developed COVID-19 post-transplant," says study co-author Dorry Segev, M.D., Ph.D., the Marjory K. and Thomas Pozefsky Professor of Surgery and Epidemiology and director of the Epidemiology Research Group in Organ Transplantation at the Johns Hopkins University School of Medicine. "Our goal was to gain a deeper understanding of the immune response in these individuals, so that clinicians will be better able to treat transplant recipients who get COVID-19, prevent their disease from becoming severe and develop vaccine protocols that fit their special needs."
The study participants, all of whom were receiving immunosuppressive medication, represented a variety of organ transplants: nine kidney, five liver, one kidney and liver, two lung and one composite tissue allograft (composed of different tissue types, such as skin, muscle, bone, bone marrow, lymph nodes, nerves and tendons). The median age was 56, 56% (10) were female, 33% (six) were Black and 11% (two) were Hispanic. COVID-19 occurred at a median of six years following transplant surgery, with 89% (16) experiencing symptoms and 72% (13) requiring hospitalization. Five patients received convalescent plasma during their hospital stay. When the participants were screened for SARS-CoV-2 antibodies at a median 98 days after COVID-19 diagnosis, the researchers observed that most had antibody levels suggesting neutralizing immunity -- the ability to prevent reinfection if exposed to the virus in the future.
Transplant recipients who had more severe cases of COVID-19, the researchers say, tended to have the highest antibody levels.
Interestingly, the researchers found that transplant recipients who received convalescent plasma or intravenous immunoglobulin (to reduce the risk of a serious inflammatory response) had lower natural antibody levels against the virus and, therefore, were less likely to have immunity.
"This raises the possibility that administered antibody preparations may blunt the natural formation of antibodies against SARS-CoV-2," says Jacqueline Garonzik Wang, M.D., Ph.D., associate professor of surgery at the Johns Hopkins University School of Medicine and study senior author. "Larger studies will be needed to substantiate this finding, which, if proven, would be invaluable to COVID-19 vaccine protocol development for the immunocompromised."
Segev and Garonzik Wang are available for interviews.
Michael E. Newman,
In what may be the first study of its kind, Johns Hopkins Medicine researchers have documented the reaction of nearly 200 solid organ transplant recipients to their first vaccine inoculation against SARS-CoV-2, the virus that causes COVID-19. The findings, they say, provide evidence that both the Moderna and Pfizer/BioNTech messenger RNA (mRNA) vaccines can be safely given to this immunocompromised population.
To better understand the safety of the SARS-CoV-2 mRNA vaccines for transplant patients, the researchers studied 187 transplant recipients who received an initial dose of either the Moderna or Pfizer/BioNTech vaccines between Dec. 16, 2020and Jan. 16, 2021. The study participants were recruited by invitation through their transplant centers or social media.
Fifty-two percent (97) were kidney transplant recipients; 19% (35) were liver; 14% (26) were heart; 9% (17) were lung; 3% (six) were kidney and pancreas; and (six) were other multi-organ recipients. The median age was 48; 69% (129) were female, 87% (163) were white; and 6% (11) were Hispanic or Latino. Vaccinations occurred at a median of six years following transplant surgery. All were receiving immunosuppression medications to prevent rejection of their transplanted organs.
Between the time of their vaccination and study participation (which consisted of completing a detailed questionnaire one week after they received the vaccine), there were no diagnoses of SARS-CoV-2 infections.
Few of the transplant recipients in the study had systemic adverse reactions, such as fever (seven, or 4%) and chills (17, or 9%), to the Moderna and Pfizer/BioNTech vaccines -- statistics that were similar to those seen for participants in the large, randomized clinical trials that validated the safety of the two prophylactic treatments. The majority of the transplant recipients reported local reactions, including mild pain at the site of inoculation (114, or 61%), mild redness (13, or 7%) and mild swelling (30, or 16%).
Additionally, the researchers say, organ rejection -- a common concern about vaccinating transplant recipients -- did not occur.
"We hope to further this research by exploring any unexpected safety issues with long-term follow-up studies of these patients in the future," says Jacqueline Garonzik Wang, M.D., Ph.D., associate professor of surgery at the Johns Hopkins University School of Medicine and study senior author.
"These insights are critical toward protecting the lives and quelling the fears of transplant recipients who might be hesitant about getting the SARS-CoV-2 vaccines," says study co-author Dorry Segev, M.D., Ph.D., the Marjory K. and Thomas Pozefsky Professor of Surgery and Epidemiology and director of the Epidemiology Research Group in Organ Transplantation at the Johns Hopkins University School of Medicine.
Garonzik Wang and Segev are available for interviews.