Infectious Diseases

Pfizer announced on Nov. 22 that its COVID-19 vaccine provided long-term protection against the virus in a late-stage clinical trial among adolescents ages 12-15.

A two-dose series was 100% effective against COVID-19, which was measured between 7 days and 4 months after the second dose.

“As the global health community works to increase the number of vaccinated people around the world, these additional data provide further confidence in our vaccine safety and effectiveness profile in adolescents,” Albert Bourla, PhD, chairman and CEO of Pfizer, said in a statement.

The clinical trial researchers found no serious safety concerns while following patients for 6 months. The adverse events were consistent with other clinical safety data for the vaccine, the company said.

Pfizer will incorporate the data into its submissions for full regulatory approval of the vaccine for ages 12-15 in the United States and worldwide.

The company will request clearance for a 30-mcg dose of the vaccines for ages 12 and older. The shot received FDA emergency use authorization for ages 12-15 in May and full approval for ages 16 and older in August.

The study included 2,228 clinical trial participants who were monitored between November 2020 and September 2021. There were 30 confirmed symptomatic cases of COVID-19 in the placebo group that didn’t receive the vaccine and 0 COVID-19 cases among the vaccinated group.

The efficacy was consistently high across gender, race, ethnicity, and health conditions, the company said.

“This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed,” Mr. Bourla said. “We look forward to sharing these data with the FDA and other regulators.”

A version of this article first appeared on WebMD.com.

Pfizer announced on Nov. 22 that its COVID-19 vaccine provided long-term protection against the virus in a late-stage clinical trial among adolescents ages 12-15.

A two-dose series was 100% effective against COVID-19, which was measured between 7 days and 4 months after the second dose.

“As the global health community works to increase the number of vaccinated people around the world, these additional data provide further confidence in our vaccine safety and effectiveness profile in adolescents,” Albert Bourla, PhD, chairman and CEO of Pfizer, said in a statement.

The clinical trial researchers found no serious safety concerns while following patients for 6 months. The adverse events were consistent with other clinical safety data for the vaccine, the company said.

Pfizer will incorporate the data into its submissions for full regulatory approval of the vaccine for ages 12-15 in the United States and worldwide.

The company will request clearance for a 30-mcg dose of the vaccines for ages 12 and older. The shot received FDA emergency use authorization for ages 12-15 in May and full approval for ages 16 and older in August.

The study included 2,228 clinical trial participants who were monitored between November 2020 and September 2021. There were 30 confirmed symptomatic cases of COVID-19 in the placebo group that didn’t receive the vaccine and 0 COVID-19 cases among the vaccinated group.

The efficacy was consistently high across gender, race, ethnicity, and health conditions, the company said.

“This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed,” Mr. Bourla said. “We look forward to sharing these data with the FDA and other regulators.”

A version of this article first appeared on WebMD.com.

Pfizer announced on Nov. 22 that its COVID-19 vaccine provided long-term protection against the virus in a late-stage clinical trial among adolescents ages 12-15.

A two-dose series was 100% effective against COVID-19, which was measured between 7 days and 4 months after the second dose.

“As the global health community works to increase the number of vaccinated people around the world, these additional data provide further confidence in our vaccine safety and effectiveness profile in adolescents,” Albert Bourla, PhD, chairman and CEO of Pfizer, said in a statement.

The clinical trial researchers found no serious safety concerns while following patients for 6 months. The adverse events were consistent with other clinical safety data for the vaccine, the company said.

Pfizer will incorporate the data into its submissions for full regulatory approval of the vaccine for ages 12-15 in the United States and worldwide.

The company will request clearance for a 30-mcg dose of the vaccines for ages 12 and older. The shot received FDA emergency use authorization for ages 12-15 in May and full approval for ages 16 and older in August.

The study included 2,228 clinical trial participants who were monitored between November 2020 and September 2021. There were 30 confirmed symptomatic cases of COVID-19 in the placebo group that didn’t receive the vaccine and 0 COVID-19 cases among the vaccinated group.

The efficacy was consistently high across gender, race, ethnicity, and health conditions, the company said.

“This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed,” Mr. Bourla said. “We look forward to sharing these data with the FDA and other regulators.”

A version of this article first appeared on WebMD.com.

Although the estimated annual number of measles deaths decreased 94% from 2000 to 2020, the COVID-19 pandemic took a toll on both measles vaccination and surveillance, according to a recent report in Morbidity and Mortality Weekly Report.

The number of World Health Organization member states that achieved more than 90% coverage with the first dose of the measles vaccine (MCV1) declined 37% from 2019 to 2020. In 2020, 23 million infants did not receive MCV1 through routine immunization services, and another 93 million were affected by the postponement of mass immunizations or supplementary immunization activities because of the pandemic. Also, endemic transmission was reestablished in nine countries that had previously eliminated measles.

But perhaps the most overlooked aspect of COVID-19 is its effect on surveillance.

“The entire COVID pandemic really put a lot of strain on the surveillance systems, not only for measles but for all vaccine-preventable disease, because there’s a lot of overlap in the staff who work for surveillance,” said Katrina Kretsinger, MD, a medical epidemiologist at the Centers for Disease Control and Prevention, who contributed to the MMWR report.

Because of the stress on the systems, a lot fewer specimens were tested, she said in an interview. And it’s not just measles that is at risk. This has had an impact on the Global Polio Eradication Initiative, which lost staff.

In addition, many vaccination campaigns “were postponed and curtailed throughout 2020,” Dr. Kretsinger said. The strengthening of surveillance systems – and immunization systems, more broadly – needs to be a priority.

“It’s not clear that the children who were missed during that year were subsequently caught up,” she explained. Having a “cohort of children who have missed measles vaccine creates the reservoir of susceptibility that will provide the nidus for the next big outbreak.”

Measles is the indicator disease. That could mean a resurgence of other vaccine-preventable diseases as well.

This report “was written by some of the world’s experts in measles, and it raises concerns about potential resurgence of measles,” said Walter Orenstein, MD, professor of medicine, epidemiology, global health, and pediatrics at Emory University, Atlanta. “Measles is sort of a canary in the coal mine. If you look at vaccine-preventable diseases, measles is probably the most contagious, so the herd-immunity threshold is highest. Usually on the order of 92%-94% immunity is needed to stop transmission.”

“Measles is the indicator disease,” he said in an interview. “That could mean a resurgence of other vaccine-preventable diseases as well.” Outbreaks don’t just affect the countries where infections are occurring, they “also affect our own domestic health security.”

“Some sort of periodic intensified routine immunization” would be helpful, said Dr. Kretsinger, who recommends “going through and selectively doing some sort of intensified efforts to catch children up early for the entire range of vaccines that they may have missed.”

“Some of these capture campaigns in areas that are thought to have the major problem would be very, very important,” agreed Dr. Orenstein. “A school entry check is one way of trying to look at kids, let’s say at 4-6 years of age, in schools around the world,” offering doses if they’re unvaccinated or inadequately vaccinated. “Another is to try to improve surveillance and try to understand if the cases are vaccine failure or failure to vaccinate.”

“Where the health systems are the most fragile is where those gaps will be the last to be filled, if they are at all, and where we have the basic concerns,” Dr. Kretsinger explained.

“Years ago, WHO recognized that vaccine hesitancy is a top global health threat,” said Dr. Orenstein. “People may not see these diseases so they don’t mean much to them. Since vaccines, we’re victims of our own success.” There’s also a lot of incorrect information circulating.

“We need to realize – and it’s been shown with COVID – that a decision not to vaccinate is not just a decision for your own child. It’s a community decision,” he pointed out. “It’s not my freedom to drive drunk, because not only do I put myself at risk, but others can’t control the car. We have speed limits and other examples where we restrict personal choice because it can adversely affect individuals.”

“My favorite line is vaccines don’t save lives, vaccinations save lives,” Dr. Orenstein said. “The vaccine dose that remains in the vial is 0% effective, no matter what the clinical trials show. And the issue, I think, is that we need to determine how to convince the hesitant to get confident enough to accept vaccination. For that, there is behavioral research; there’s a whole bunch of things that need to be supported. Just purchasing the vaccine doesn’t get it into the bodies.”

Dr. Kretsinger and Dr. Orenstein disclosed no relevant financial relationships .

A version of this article first appeared on Medscape.com.

Although the estimated annual number of measles deaths decreased 94% from 2000 to 2020, the COVID-19 pandemic took a toll on both measles vaccination and surveillance, according to a recent report in Morbidity and Mortality Weekly Report.

The number of World Health Organization member states that achieved more than 90% coverage with the first dose of the measles vaccine (MCV1) declined 37% from 2019 to 2020. In 2020, 23 million infants did not receive MCV1 through routine immunization services, and another 93 million were affected by the postponement of mass immunizations or supplementary immunization activities because of the pandemic. Also, endemic transmission was reestablished in nine countries that had previously eliminated measles.

But perhaps the most overlooked aspect of COVID-19 is its effect on surveillance.

“The entire COVID pandemic really put a lot of strain on the surveillance systems, not only for measles but for all vaccine-preventable disease, because there’s a lot of overlap in the staff who work for surveillance,” said Katrina Kretsinger, MD, a medical epidemiologist at the Centers for Disease Control and Prevention, who contributed to the MMWR report.

Because of the stress on the systems, a lot fewer specimens were tested, she said in an interview. And it’s not just measles that is at risk. This has had an impact on the Global Polio Eradication Initiative, which lost staff.

In addition, many vaccination campaigns “were postponed and curtailed throughout 2020,” Dr. Kretsinger said. The strengthening of surveillance systems – and immunization systems, more broadly – needs to be a priority.

“It’s not clear that the children who were missed during that year were subsequently caught up,” she explained. Having a “cohort of children who have missed measles vaccine creates the reservoir of susceptibility that will provide the nidus for the next big outbreak.”

Measles is the indicator disease. That could mean a resurgence of other vaccine-preventable diseases as well.

This report “was written by some of the world’s experts in measles, and it raises concerns about potential resurgence of measles,” said Walter Orenstein, MD, professor of medicine, epidemiology, global health, and pediatrics at Emory University, Atlanta. “Measles is sort of a canary in the coal mine. If you look at vaccine-preventable diseases, measles is probably the most contagious, so the herd-immunity threshold is highest. Usually on the order of 92%-94% immunity is needed to stop transmission.”

“Measles is the indicator disease,” he said in an interview. “That could mean a resurgence of other vaccine-preventable diseases as well.” Outbreaks don’t just affect the countries where infections are occurring, they “also affect our own domestic health security.”

“Some sort of periodic intensified routine immunization” would be helpful, said Dr. Kretsinger, who recommends “going through and selectively doing some sort of intensified efforts to catch children up early for the entire range of vaccines that they may have missed.”

“Some of these capture campaigns in areas that are thought to have the major problem would be very, very important,” agreed Dr. Orenstein. “A school entry check is one way of trying to look at kids, let’s say at 4-6 years of age, in schools around the world,” offering doses if they’re unvaccinated or inadequately vaccinated. “Another is to try to improve surveillance and try to understand if the cases are vaccine failure or failure to vaccinate.”

“Where the health systems are the most fragile is where those gaps will be the last to be filled, if they are at all, and where we have the basic concerns,” Dr. Kretsinger explained.

“Years ago, WHO recognized that vaccine hesitancy is a top global health threat,” said Dr. Orenstein. “People may not see these diseases so they don’t mean much to them. Since vaccines, we’re victims of our own success.” There’s also a lot of incorrect information circulating.

“We need to realize – and it’s been shown with COVID – that a decision not to vaccinate is not just a decision for your own child. It’s a community decision,” he pointed out. “It’s not my freedom to drive drunk, because not only do I put myself at risk, but others can’t control the car. We have speed limits and other examples where we restrict personal choice because it can adversely affect individuals.”

“My favorite line is vaccines don’t save lives, vaccinations save lives,” Dr. Orenstein said. “The vaccine dose that remains in the vial is 0% effective, no matter what the clinical trials show. And the issue, I think, is that we need to determine how to convince the hesitant to get confident enough to accept vaccination. For that, there is behavioral research; there’s a whole bunch of things that need to be supported. Just purchasing the vaccine doesn’t get it into the bodies.”

Dr. Kretsinger and Dr. Orenstein disclosed no relevant financial relationships .

A version of this article first appeared on Medscape.com.

Although the estimated annual number of measles deaths decreased 94% from 2000 to 2020, the COVID-19 pandemic took a toll on both measles vaccination and surveillance, according to a recent report in Morbidity and Mortality Weekly Report.

The number of World Health Organization member states that achieved more than 90% coverage with the first dose of the measles vaccine (MCV1) declined 37% from 2019 to 2020. In 2020, 23 million infants did not receive MCV1 through routine immunization services, and another 93 million were affected by the postponement of mass immunizations or supplementary immunization activities because of the pandemic. Also, endemic transmission was reestablished in nine countries that had previously eliminated measles.

But perhaps the most overlooked aspect of COVID-19 is its effect on surveillance.

“The entire COVID pandemic really put a lot of strain on the surveillance systems, not only for measles but for all vaccine-preventable disease, because there’s a lot of overlap in the staff who work for surveillance,” said Katrina Kretsinger, MD, a medical epidemiologist at the Centers for Disease Control and Prevention, who contributed to the MMWR report.

Because of the stress on the systems, a lot fewer specimens were tested, she said in an interview. And it’s not just measles that is at risk. This has had an impact on the Global Polio Eradication Initiative, which lost staff.

In addition, many vaccination campaigns “were postponed and curtailed throughout 2020,” Dr. Kretsinger said. The strengthening of surveillance systems – and immunization systems, more broadly – needs to be a priority.

“It’s not clear that the children who were missed during that year were subsequently caught up,” she explained. Having a “cohort of children who have missed measles vaccine creates the reservoir of susceptibility that will provide the nidus for the next big outbreak.”

Measles is the indicator disease. That could mean a resurgence of other vaccine-preventable diseases as well.

This report “was written by some of the world’s experts in measles, and it raises concerns about potential resurgence of measles,” said Walter Orenstein, MD, professor of medicine, epidemiology, global health, and pediatrics at Emory University, Atlanta. “Measles is sort of a canary in the coal mine. If you look at vaccine-preventable diseases, measles is probably the most contagious, so the herd-immunity threshold is highest. Usually on the order of 92%-94% immunity is needed to stop transmission.”

“Measles is the indicator disease,” he said in an interview. “That could mean a resurgence of other vaccine-preventable diseases as well.” Outbreaks don’t just affect the countries where infections are occurring, they “also affect our own domestic health security.”

“Some sort of periodic intensified routine immunization” would be helpful, said Dr. Kretsinger, who recommends “going through and selectively doing some sort of intensified efforts to catch children up early for the entire range of vaccines that they may have missed.”

“Some of these capture campaigns in areas that are thought to have the major problem would be very, very important,” agreed Dr. Orenstein. “A school entry check is one way of trying to look at kids, let’s say at 4-6 years of age, in schools around the world,” offering doses if they’re unvaccinated or inadequately vaccinated. “Another is to try to improve surveillance and try to understand if the cases are vaccine failure or failure to vaccinate.”

“Where the health systems are the most fragile is where those gaps will be the last to be filled, if they are at all, and where we have the basic concerns,” Dr. Kretsinger explained.

“Years ago, WHO recognized that vaccine hesitancy is a top global health threat,” said Dr. Orenstein. “People may not see these diseases so they don’t mean much to them. Since vaccines, we’re victims of our own success.” There’s also a lot of incorrect information circulating.

“We need to realize – and it’s been shown with COVID – that a decision not to vaccinate is not just a decision for your own child. It’s a community decision,” he pointed out. “It’s not my freedom to drive drunk, because not only do I put myself at risk, but others can’t control the car. We have speed limits and other examples where we restrict personal choice because it can adversely affect individuals.”

“My favorite line is vaccines don’t save lives, vaccinations save lives,” Dr. Orenstein said. “The vaccine dose that remains in the vial is 0% effective, no matter what the clinical trials show. And the issue, I think, is that we need to determine how to convince the hesitant to get confident enough to accept vaccination. For that, there is behavioral research; there’s a whole bunch of things that need to be supported. Just purchasing the vaccine doesn’t get it into the bodies.”

Dr. Kretsinger and Dr. Orenstein disclosed no relevant financial relationships .

A version of this article first appeared on Medscape.com.

From Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Birmingham, United Kingdom.

Objective: To ascertain the extent of nasogastric tube (NGT) dislodgment in COVID-19 intensive care unit (ICU) patients after the introduction of NGT bridle kits as a standard of practice, to see whether this would reduce the number of NGT insertions, patient irradiation, missed feeds, and overall cost.

Background: Nasogastric feeding is the mainstay of enteral feeding for ICU patients. The usual standard of practice is to secure the tube using adhesive tape. Studies show this method has a 40% to 48% dislodgment rate. The COVID-19 ICU patient population may be at even greater risk due to the need for proning, long duration of invasive ventilation, and emergence delirium.

Design: This was a 2-cycle quality improvement project. The first cycle was done retrospectively, looking at the contemporaneous standard of practice where bridle kits were not used. This gave an objective measure of the extent of NGT displacement, associated costs, and missed feeds. The second cycle was carried out prospectively, with the use of NGT bridle kits as the new standard of practice.

Setting: A large United Kingdom teaching hospital with a 100-bed, single-floor ICU.

Participants: Patients admitted to the ICU with COVID-19 who subsequently required sedation and invasive ventilation.

Measurements: Measurements included days of feeding required, hours of feeding missed due to NGT dislodgment, total number of nasogastric tubes required per ICU stay, and number of chest radiographs for NGT position confirmation. NGT-related pressure sores were also recorded.

Results: When compared to the bridled group, the unbridled group required a higher number of NGTs (2.5 vs 1.3; P < .001) and chest radiographs (3.4 vs 1.6; P < .001), had more hours of feeding missed (11.8 vs 5.0), and accumulated a slightly higher total cost (cost of NGT, chest radiographs +/- bridle kit: £211.67 vs £210, [US $284.25 vs US $282.01]).

Conclusions: The use of NGT bridle kits reduces the number of NGT insertions patients require and subsequently reduces the number of chest radiographs for each patient. These patients also miss fewer feeds, with no appreciable increase in cost.

Keywords: nasogastric, bridle, enteral, COVID-19, intensive care, quality improvement, safety.

The COVID-19 pandemic has led to a large influx of patients to critical care units in the United Kingdom (UK) and across the world. Figures from the Intensive Care National Audit & Research Centre in May 2020 show that the median length of stay for COVID-19 survivors requiring invasive ventilatory support while on the intensive care unit (ICU) was 15 days.¹ For these days at the very least, patients are completely reliant on enteral feeding in order to meet their nutritional requirements.The standard method of enteral feeding when a patient is sedated and ventilated is via a nasogastric tube (NGT). Incorrect placement of an NGT can have devastating consequences, including pneumothorax, fistula formation, ulceration, sepsis, and death. Between September 2011 and March 2016, the National Patient Safety Agency in the UK recorded 95 incidents of feeding into the respiratory tract as a result of incorrect NGT placement.² With the onset of the pandemic, the prevalence of NGT misplacement increased, with the NHS Improvement team reporting 7 cases of misplaced NGTs within just 3 months (April 1, 2020, through June 30, 2020).³ With over 3 million nasogastric or orogastric tubes inserted each year in the UK, the risk of adverse events is very real.

NGT dislodgment is common, with 1 study putting this figure at 40%.⁴ Recurrent dislodgment of NGTs disrupts nutrition and may lead to the patient missing a feed in a time where nutrition is vital during acute illness. Research has showed that NGT bridling reduces the rate of dislodgment significantly (from 40% to 14%).⁵ Moreover, a 2018 systematic review looking specifically at NGT dislodgment found 10 out of 11 studies showed a significant reduction in dislodgment following use of a bridle kit.⁶ Bridling an NGT has been shown to significantly reduce the need for percutaneous endoscopic gastrostomy insertion.⁷ NGT bridle kits have already been used successfully in ICU burn patients, where sloughed skin makes securement particularly difficult with traditional methods.⁸ With each repeated insertion comes the risk of incorrect placement. COVID-19 ICU patients had specific risk factors for their NGTs becoming dislodged: duration of NGT feeding (in the ICU and on the ward), requirement for proning and de-proning, and post-emergence confusion related to long duration of sedation. Repeated NGT insertion comes with potential risks to the patient and staff, as well as a financial cost. Patient-specific risks include potential for incorrect placement, missed feedings, irradiation (from the patient’s own chest radiograph and from others), and discomfort from manual handling and repeat reinsertions. Staff risk factors include radiation scatter from portable radiographs (especially when dealing with more than 1 patient per bed space), manual handling, and increased pressure on radiographers. Finally, financial costs are related to the NGTs themselves as well as the portable chest radiograph, which our Superintendent Radiographer estimates to be £55 (US $73.86).

The objective of this study was to ascertain the extent of NGT dislodgment in COVID-19 ICU patients after the introduction of NGT bridle kits as a standard of practice and to determine whether this would reduce the number of NGT insertions, patient irradiation, missed feedings, and overall costs. With the introduction of bridle kits, incidence of pressure sores related to the bridle kit were also recorded.

Methods

Data were collected over 2 cycles, the first retrospectively and the second prospectively, once NGT bridle kits were introduced as an intervention.

Cycle 1. Analyzing the current standard of practice: regular NGT insertion with no use of bridle kit

Cycle 1 was done retrospectively, looking at 30 patient notes of COVID-19 patients admitted to the critical care unit (CCU) between March 11, 2020, and April 20, 2020, at Queen Elizabeth Hospital Birmingham, Birmingham, UK. All patients admitted to the ICU with COVID-19 requiring invasive ventilation were eligible for inclusion in the study. A total of 32 patients were admitted during this time; however, 2 patients were excluded due to NGTs being inserted prior to ICU admission.

Individual patient notes were searched for:

• days of feeding required during their inpatient stay (this included NGT feeding on the ward post-ICU discharge).
• hours of feeding missed while waiting for NGT reinsertion or chest radiograph due to dislodged or displaced NGTs (during the entire period of enteral feeding, ICU, and ward).
• number of NGT insertions.
• number of chest radiographs purely for NGT position.

Each patient’s first day of feeding and NGT insertion were noted. Following that, the patient electronic note system, the Prescribing Information and Communication System, was used to look for any further chest radiograph requests, which were primarily for NGT position. Using the date and time, the “critical care observations” tab was used to look at fluids and to calculate how long NGT feeding was stopped while NGT position-check x-rays were being awaited. The notes were also checked at this date and time to work out whether a new NGT was inserted or whether an existing tube had been dislodged (if not evident from the x-ray request). Data collection was stopped once either of the following occurred:

• patient no longer required NGT feeding.
• patient was transferred to another hospital.
• death.

The cost of the NGT was averaged between the cost of size 8 and 12, which worked out to be £10 (US $13.43). As mentioned earlier, each radiograph cost was determined by the Superintendent Radiographer (£55).

Cycle 2. Implementing a change: introduction of NGT bridle kit (Applied Medical Technology Bridle) as standard of practice

The case notes of 54 patients admitted to the COVID-19 CCU at the Queen Elizabeth Hospital Birmingham, Birmingham, UK, were retrospectively reviewed between February 8, 2021, and April 17, 2021. The inclusion criteria consisted of: admitted to the CCU due to COVID-19, required NGT feeding, and was bridled on admission. Case notes were retrospectively reviewed for:

• Length of CCU stay
• Days of feeding required during the hospital stay
• Hours of feeding missed while waiting for a chest radiograph due to displaced NGTs
• Number of NGT insertions
• Number of chest radiographs to confirm NGT position
• Bridling of NGTs
• Documented pressure sores related to the bridle or NGT, or referrals for wound management advice (Tissue Viability Team) as a consequence of the NGT bridle

Results

Of the 54 patients admitted, 31 had their NGTs bridled. Data were collected as in the first cycle, with individual notes analyzed on the online system (Table). Additionally, notes were reviewed for documentation of pressure sores related to NGT bridling, and the “requests” tab as well as the “noting” function were used to identify referrals for “Wound Management Advice” (Tissue Viability Review).

The average length of stay for this ICU cohort was 17.6 days. This reiterates the reliance on NGT feeding of patients admitted to the CCU. The results from this project can be summarized as follows: The use of NGT bridle kits leads to a significant reduction in the total number of NGTs a patient requires during intensive care. As a result, there is a significant reduction in the number of chest radiographs required to confirm NGT position. Feedings missed can also be reduced by using a bridle kit. These advantages all come with no additional cost.

On average, bridled patients required 1.3 NGTs, compared to 2.5 before bridles were introduced. The fewer NGTs inserted, the less chance of an NGT-associated injury occurring.

The number of chest radiographs required to confirm NGT position after resiting also fell, from 3.4 to 1.6. This has numerous advantages. There is a financial savings of £99 (US $133.04) per patient from the reduced number of chest x-rays. Although this does not offset the price of the bridle kit itself, there are other less easily quantifiable costs that are reduced. For instance, patients are highly catabolic during severe infection, and their predominant energy source comes from their feedings. Missed feedings are associated with longer length of stay in the ICU and in the hospital in general.⁹ Bridle kits have the potential to reduce the number of missed feedings by ensuring the NGT remains in the correct position.

Discussion

Many of the results are aligned with what is already known in the literature. A meta-analysis from 2014 concluded that dislodgment is reduced with the use of a bridle kit.⁶ This change is what underpins many of the advantages seen, as an NGT that stays in place means additional radiographs are not required and feeding is not delayed.

COVID-19 critical care patients are very fragile and are dependent on ventilators for the majority of their stay. They are often on very high levels of ventilator support and moving the patient can lead to desaturation or difficulties in ventilation. Therefore, reduction in any manual handling occurring as a result of the need for portable chest radiographs minimizes the chances of further negative events. Furthermore, nursing staff, along with the radiographers, are often the ones who must move these patients in order for the x-ray film to be placed behind the patient. This task is not easy, especially with limited personnel, and has the potential to cause injuries to both patients and staff members.

One concern noted was that bridles could cause increased incidence of pressure sores. In the patients represented in this study, only 1 suffered a pressure sore (grade 2) directly related to the bridle. A subpopulation of patients not bridled was also noted. This was significantly smaller than the main group; however, we had noted 2 incidences of pressure sores from their standard NGT and securement devices. Some studies have alluded to the potential for increased skin complications with bridle kits; however, studies looking specifically at kits using umbilical tape (as in this study) show no significant increase in skin damage.¹⁰ This leaves us confident that there is no increased risk of pressure sores related to the bridling of patients when umbilical tape is used with the bridle kit.

NGT bridles require training to insert safely. With the introduction of bridling, our hospital’s nursing staff underwent training in order to be proficient with the bridle kits. This comes with a time commitment, and, like other equipment usage, it takes time to build confidence. However, in this study, there were no concerns raised from nursing staff regarding difficulty of insertion or the time taken to do so.

Conclusion

The COVID-19 critical care population requires significant time on invasive ventilation and remains dependent on NGT feeding during this process. The risk of NGT dislodgment can be mitigated by using a bridle kit, as the number of NGT insertions a patient requires is significantly reduced. Not only does this reduce the risk of inadvertent misplacement but also has a cost savings, as well as increasing safety for staff and patients. From this study, the risk of pressure injuries is not significant. The benefit of NGT bridling may be extended to other non-COVID long-stay ICU patients.

Future research looking at the efficacy of bridle kits in larger patient groups will help confirm the benefits seen in this study and will also provide better information with regard to any long-term complications associated with bridles.

Corresponding author: Rajveer Atkar, MBBS, Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Birmingham B15 2GW, United Kingdom; [email protected].

Financial disclosures: None.

From Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Birmingham, United Kingdom.

Objective: To ascertain the extent of nasogastric tube (NGT) dislodgment in COVID-19 intensive care unit (ICU) patients after the introduction of NGT bridle kits as a standard of practice, to see whether this would reduce the number of NGT insertions, patient irradiation, missed feeds, and overall cost.

Background: Nasogastric feeding is the mainstay of enteral feeding for ICU patients. The usual standard of practice is to secure the tube using adhesive tape. Studies show this method has a 40% to 48% dislodgment rate. The COVID-19 ICU patient population may be at even greater risk due to the need for proning, long duration of invasive ventilation, and emergence delirium.

Design: This was a 2-cycle quality improvement project. The first cycle was done retrospectively, looking at the contemporaneous standard of practice where bridle kits were not used. This gave an objective measure of the extent of NGT displacement, associated costs, and missed feeds. The second cycle was carried out prospectively, with the use of NGT bridle kits as the new standard of practice.

Setting: A large United Kingdom teaching hospital with a 100-bed, single-floor ICU.

Participants: Patients admitted to the ICU with COVID-19 who subsequently required sedation and invasive ventilation.

Measurements: Measurements included days of feeding required, hours of feeding missed due to NGT dislodgment, total number of nasogastric tubes required per ICU stay, and number of chest radiographs for NGT position confirmation. NGT-related pressure sores were also recorded.

Results: When compared to the bridled group, the unbridled group required a higher number of NGTs (2.5 vs 1.3; P < .001) and chest radiographs (3.4 vs 1.6; P < .001), had more hours of feeding missed (11.8 vs 5.0), and accumulated a slightly higher total cost (cost of NGT, chest radiographs +/- bridle kit: £211.67 vs £210, [US $284.25 vs US $282.01]).

Conclusions: The use of NGT bridle kits reduces the number of NGT insertions patients require and subsequently reduces the number of chest radiographs for each patient. These patients also miss fewer feeds, with no appreciable increase in cost.

Keywords: nasogastric, bridle, enteral, COVID-19, intensive care, quality improvement, safety.

The COVID-19 pandemic has led to a large influx of patients to critical care units in the United Kingdom (UK) and across the world. Figures from the Intensive Care National Audit & Research Centre in May 2020 show that the median length of stay for COVID-19 survivors requiring invasive ventilatory support while on the intensive care unit (ICU) was 15 days.¹ For these days at the very least, patients are completely reliant on enteral feeding in order to meet their nutritional requirements.The standard method of enteral feeding when a patient is sedated and ventilated is via a nasogastric tube (NGT). Incorrect placement of an NGT can have devastating consequences, including pneumothorax, fistula formation, ulceration, sepsis, and death. Between September 2011 and March 2016, the National Patient Safety Agency in the UK recorded 95 incidents of feeding into the respiratory tract as a result of incorrect NGT placement.² With the onset of the pandemic, the prevalence of NGT misplacement increased, with the NHS Improvement team reporting 7 cases of misplaced NGTs within just 3 months (April 1, 2020, through June 30, 2020).³ With over 3 million nasogastric or orogastric tubes inserted each year in the UK, the risk of adverse events is very real.

NGT dislodgment is common, with 1 study putting this figure at 40%.⁴ Recurrent dislodgment of NGTs disrupts nutrition and may lead to the patient missing a feed in a time where nutrition is vital during acute illness. Research has showed that NGT bridling reduces the rate of dislodgment significantly (from 40% to 14%).⁵ Moreover, a 2018 systematic review looking specifically at NGT dislodgment found 10 out of 11 studies showed a significant reduction in dislodgment following use of a bridle kit.⁶ Bridling an NGT has been shown to significantly reduce the need for percutaneous endoscopic gastrostomy insertion.⁷ NGT bridle kits have already been used successfully in ICU burn patients, where sloughed skin makes securement particularly difficult with traditional methods.⁸ With each repeated insertion comes the risk of incorrect placement. COVID-19 ICU patients had specific risk factors for their NGTs becoming dislodged: duration of NGT feeding (in the ICU and on the ward), requirement for proning and de-proning, and post-emergence confusion related to long duration of sedation. Repeated NGT insertion comes with potential risks to the patient and staff, as well as a financial cost. Patient-specific risks include potential for incorrect placement, missed feedings, irradiation (from the patient’s own chest radiograph and from others), and discomfort from manual handling and repeat reinsertions. Staff risk factors include radiation scatter from portable radiographs (especially when dealing with more than 1 patient per bed space), manual handling, and increased pressure on radiographers. Finally, financial costs are related to the NGTs themselves as well as the portable chest radiograph, which our Superintendent Radiographer estimates to be £55 (US $73.86).

The objective of this study was to ascertain the extent of NGT dislodgment in COVID-19 ICU patients after the introduction of NGT bridle kits as a standard of practice and to determine whether this would reduce the number of NGT insertions, patient irradiation, missed feedings, and overall costs. With the introduction of bridle kits, incidence of pressure sores related to the bridle kit were also recorded.

Methods

Data were collected over 2 cycles, the first retrospectively and the second prospectively, once NGT bridle kits were introduced as an intervention.

Cycle 1. Analyzing the current standard of practice: regular NGT insertion with no use of bridle kit

Cycle 1 was done retrospectively, looking at 30 patient notes of COVID-19 patients admitted to the critical care unit (CCU) between March 11, 2020, and April 20, 2020, at Queen Elizabeth Hospital Birmingham, Birmingham, UK. All patients admitted to the ICU with COVID-19 requiring invasive ventilation were eligible for inclusion in the study. A total of 32 patients were admitted during this time; however, 2 patients were excluded due to NGTs being inserted prior to ICU admission.

Individual patient notes were searched for:

• days of feeding required during their inpatient stay (this included NGT feeding on the ward post-ICU discharge).
• hours of feeding missed while waiting for NGT reinsertion or chest radiograph due to dislodged or displaced NGTs (during the entire period of enteral feeding, ICU, and ward).
• number of NGT insertions.
• number of chest radiographs purely for NGT position.

Each patient’s first day of feeding and NGT insertion were noted. Following that, the patient electronic note system, the Prescribing Information and Communication System, was used to look for any further chest radiograph requests, which were primarily for NGT position. Using the date and time, the “critical care observations” tab was used to look at fluids and to calculate how long NGT feeding was stopped while NGT position-check x-rays were being awaited. The notes were also checked at this date and time to work out whether a new NGT was inserted or whether an existing tube had been dislodged (if not evident from the x-ray request). Data collection was stopped once either of the following occurred:

• patient no longer required NGT feeding.
• patient was transferred to another hospital.
• death.

The cost of the NGT was averaged between the cost of size 8 and 12, which worked out to be £10 (US $13.43). As mentioned earlier, each radiograph cost was determined by the Superintendent Radiographer (£55).

Cycle 2. Implementing a change: introduction of NGT bridle kit (Applied Medical Technology Bridle) as standard of practice

The case notes of 54 patients admitted to the COVID-19 CCU at the Queen Elizabeth Hospital Birmingham, Birmingham, UK, were retrospectively reviewed between February 8, 2021, and April 17, 2021. The inclusion criteria consisted of: admitted to the CCU due to COVID-19, required NGT feeding, and was bridled on admission. Case notes were retrospectively reviewed for:

• Length of CCU stay
• Days of feeding required during the hospital stay
• Hours of feeding missed while waiting for a chest radiograph due to displaced NGTs
• Number of NGT insertions
• Number of chest radiographs to confirm NGT position
• Bridling of NGTs
• Documented pressure sores related to the bridle or NGT, or referrals for wound management advice (Tissue Viability Team) as a consequence of the NGT bridle

Results

Of the 54 patients admitted, 31 had their NGTs bridled. Data were collected as in the first cycle, with individual notes analyzed on the online system (Table). Additionally, notes were reviewed for documentation of pressure sores related to NGT bridling, and the “requests” tab as well as the “noting” function were used to identify referrals for “Wound Management Advice” (Tissue Viability Review).

The average length of stay for this ICU cohort was 17.6 days. This reiterates the reliance on NGT feeding of patients admitted to the CCU. The results from this project can be summarized as follows: The use of NGT bridle kits leads to a significant reduction in the total number of NGTs a patient requires during intensive care. As a result, there is a significant reduction in the number of chest radiographs required to confirm NGT position. Feedings missed can also be reduced by using a bridle kit. These advantages all come with no additional cost.

On average, bridled patients required 1.3 NGTs, compared to 2.5 before bridles were introduced. The fewer NGTs inserted, the less chance of an NGT-associated injury occurring.

The number of chest radiographs required to confirm NGT position after resiting also fell, from 3.4 to 1.6. This has numerous advantages. There is a financial savings of £99 (US $133.04) per patient from the reduced number of chest x-rays. Although this does not offset the price of the bridle kit itself, there are other less easily quantifiable costs that are reduced. For instance, patients are highly catabolic during severe infection, and their predominant energy source comes from their feedings. Missed feedings are associated with longer length of stay in the ICU and in the hospital in general.⁹ Bridle kits have the potential to reduce the number of missed feedings by ensuring the NGT remains in the correct position.

Discussion

Many of the results are aligned with what is already known in the literature. A meta-analysis from 2014 concluded that dislodgment is reduced with the use of a bridle kit.⁶ This change is what underpins many of the advantages seen, as an NGT that stays in place means additional radiographs are not required and feeding is not delayed.

COVID-19 critical care patients are very fragile and are dependent on ventilators for the majority of their stay. They are often on very high levels of ventilator support and moving the patient can lead to desaturation or difficulties in ventilation. Therefore, reduction in any manual handling occurring as a result of the need for portable chest radiographs minimizes the chances of further negative events. Furthermore, nursing staff, along with the radiographers, are often the ones who must move these patients in order for the x-ray film to be placed behind the patient. This task is not easy, especially with limited personnel, and has the potential to cause injuries to both patients and staff members.

One concern noted was that bridles could cause increased incidence of pressure sores. In the patients represented in this study, only 1 suffered a pressure sore (grade 2) directly related to the bridle. A subpopulation of patients not bridled was also noted. This was significantly smaller than the main group; however, we had noted 2 incidences of pressure sores from their standard NGT and securement devices. Some studies have alluded to the potential for increased skin complications with bridle kits; however, studies looking specifically at kits using umbilical tape (as in this study) show no significant increase in skin damage.¹⁰ This leaves us confident that there is no increased risk of pressure sores related to the bridling of patients when umbilical tape is used with the bridle kit.

NGT bridles require training to insert safely. With the introduction of bridling, our hospital’s nursing staff underwent training in order to be proficient with the bridle kits. This comes with a time commitment, and, like other equipment usage, it takes time to build confidence. However, in this study, there were no concerns raised from nursing staff regarding difficulty of insertion or the time taken to do so.

Conclusion

The COVID-19 critical care population requires significant time on invasive ventilation and remains dependent on NGT feeding during this process. The risk of NGT dislodgment can be mitigated by using a bridle kit, as the number of NGT insertions a patient requires is significantly reduced. Not only does this reduce the risk of inadvertent misplacement but also has a cost savings, as well as increasing safety for staff and patients. From this study, the risk of pressure injuries is not significant. The benefit of NGT bridling may be extended to other non-COVID long-stay ICU patients.

Future research looking at the efficacy of bridle kits in larger patient groups will help confirm the benefits seen in this study and will also provide better information with regard to any long-term complications associated with bridles.

Corresponding author: Rajveer Atkar, MBBS, Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Birmingham B15 2GW, United Kingdom; [email protected].

Financial disclosures: None.

From Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Birmingham, United Kingdom.

Objective: To ascertain the extent of nasogastric tube (NGT) dislodgment in COVID-19 intensive care unit (ICU) patients after the introduction of NGT bridle kits as a standard of practice, to see whether this would reduce the number of NGT insertions, patient irradiation, missed feeds, and overall cost.

Background: Nasogastric feeding is the mainstay of enteral feeding for ICU patients. The usual standard of practice is to secure the tube using adhesive tape. Studies show this method has a 40% to 48% dislodgment rate. The COVID-19 ICU patient population may be at even greater risk due to the need for proning, long duration of invasive ventilation, and emergence delirium.

Design: This was a 2-cycle quality improvement project. The first cycle was done retrospectively, looking at the contemporaneous standard of practice where bridle kits were not used. This gave an objective measure of the extent of NGT displacement, associated costs, and missed feeds. The second cycle was carried out prospectively, with the use of NGT bridle kits as the new standard of practice.

Setting: A large United Kingdom teaching hospital with a 100-bed, single-floor ICU.

Participants: Patients admitted to the ICU with COVID-19 who subsequently required sedation and invasive ventilation.

Measurements: Measurements included days of feeding required, hours of feeding missed due to NGT dislodgment, total number of nasogastric tubes required per ICU stay, and number of chest radiographs for NGT position confirmation. NGT-related pressure sores were also recorded.

Results: When compared to the bridled group, the unbridled group required a higher number of NGTs (2.5 vs 1.3; P < .001) and chest radiographs (3.4 vs 1.6; P < .001), had more hours of feeding missed (11.8 vs 5.0), and accumulated a slightly higher total cost (cost of NGT, chest radiographs +/- bridle kit: £211.67 vs £210, [US $284.25 vs US $282.01]).

Conclusions: The use of NGT bridle kits reduces the number of NGT insertions patients require and subsequently reduces the number of chest radiographs for each patient. These patients also miss fewer feeds, with no appreciable increase in cost.

Keywords: nasogastric, bridle, enteral, COVID-19, intensive care, quality improvement, safety.

The COVID-19 pandemic has led to a large influx of patients to critical care units in the United Kingdom (UK) and across the world. Figures from the Intensive Care National Audit & Research Centre in May 2020 show that the median length of stay for COVID-19 survivors requiring invasive ventilatory support while on the intensive care unit (ICU) was 15 days.¹ For these days at the very least, patients are completely reliant on enteral feeding in order to meet their nutritional requirements.The standard method of enteral feeding when a patient is sedated and ventilated is via a nasogastric tube (NGT). Incorrect placement of an NGT can have devastating consequences, including pneumothorax, fistula formation, ulceration, sepsis, and death. Between September 2011 and March 2016, the National Patient Safety Agency in the UK recorded 95 incidents of feeding into the respiratory tract as a result of incorrect NGT placement.² With the onset of the pandemic, the prevalence of NGT misplacement increased, with the NHS Improvement team reporting 7 cases of misplaced NGTs within just 3 months (April 1, 2020, through June 30, 2020).³ With over 3 million nasogastric or orogastric tubes inserted each year in the UK, the risk of adverse events is very real.

NGT dislodgment is common, with 1 study putting this figure at 40%.⁴ Recurrent dislodgment of NGTs disrupts nutrition and may lead to the patient missing a feed in a time where nutrition is vital during acute illness. Research has showed that NGT bridling reduces the rate of dislodgment significantly (from 40% to 14%).⁵ Moreover, a 2018 systematic review looking specifically at NGT dislodgment found 10 out of 11 studies showed a significant reduction in dislodgment following use of a bridle kit.⁶ Bridling an NGT has been shown to significantly reduce the need for percutaneous endoscopic gastrostomy insertion.⁷ NGT bridle kits have already been used successfully in ICU burn patients, where sloughed skin makes securement particularly difficult with traditional methods.⁸ With each repeated insertion comes the risk of incorrect placement. COVID-19 ICU patients had specific risk factors for their NGTs becoming dislodged: duration of NGT feeding (in the ICU and on the ward), requirement for proning and de-proning, and post-emergence confusion related to long duration of sedation. Repeated NGT insertion comes with potential risks to the patient and staff, as well as a financial cost. Patient-specific risks include potential for incorrect placement, missed feedings, irradiation (from the patient’s own chest radiograph and from others), and discomfort from manual handling and repeat reinsertions. Staff risk factors include radiation scatter from portable radiographs (especially when dealing with more than 1 patient per bed space), manual handling, and increased pressure on radiographers. Finally, financial costs are related to the NGTs themselves as well as the portable chest radiograph, which our Superintendent Radiographer estimates to be £55 (US $73.86).

The objective of this study was to ascertain the extent of NGT dislodgment in COVID-19 ICU patients after the introduction of NGT bridle kits as a standard of practice and to determine whether this would reduce the number of NGT insertions, patient irradiation, missed feedings, and overall costs. With the introduction of bridle kits, incidence of pressure sores related to the bridle kit were also recorded.

Methods

Data were collected over 2 cycles, the first retrospectively and the second prospectively, once NGT bridle kits were introduced as an intervention.

Cycle 1. Analyzing the current standard of practice: regular NGT insertion with no use of bridle kit

Cycle 1 was done retrospectively, looking at 30 patient notes of COVID-19 patients admitted to the critical care unit (CCU) between March 11, 2020, and April 20, 2020, at Queen Elizabeth Hospital Birmingham, Birmingham, UK. All patients admitted to the ICU with COVID-19 requiring invasive ventilation were eligible for inclusion in the study. A total of 32 patients were admitted during this time; however, 2 patients were excluded due to NGTs being inserted prior to ICU admission.

Individual patient notes were searched for:

• days of feeding required during their inpatient stay (this included NGT feeding on the ward post-ICU discharge).
• hours of feeding missed while waiting for NGT reinsertion or chest radiograph due to dislodged or displaced NGTs (during the entire period of enteral feeding, ICU, and ward).
• number of NGT insertions.
• number of chest radiographs purely for NGT position.

Each patient’s first day of feeding and NGT insertion were noted. Following that, the patient electronic note system, the Prescribing Information and Communication System, was used to look for any further chest radiograph requests, which were primarily for NGT position. Using the date and time, the “critical care observations” tab was used to look at fluids and to calculate how long NGT feeding was stopped while NGT position-check x-rays were being awaited. The notes were also checked at this date and time to work out whether a new NGT was inserted or whether an existing tube had been dislodged (if not evident from the x-ray request). Data collection was stopped once either of the following occurred:

• patient no longer required NGT feeding.
• patient was transferred to another hospital.
• death.

The cost of the NGT was averaged between the cost of size 8 and 12, which worked out to be £10 (US $13.43). As mentioned earlier, each radiograph cost was determined by the Superintendent Radiographer (£55).

Cycle 2. Implementing a change: introduction of NGT bridle kit (Applied Medical Technology Bridle) as standard of practice

The case notes of 54 patients admitted to the COVID-19 CCU at the Queen Elizabeth Hospital Birmingham, Birmingham, UK, were retrospectively reviewed between February 8, 2021, and April 17, 2021. The inclusion criteria consisted of: admitted to the CCU due to COVID-19, required NGT feeding, and was bridled on admission. Case notes were retrospectively reviewed for:

• Length of CCU stay
• Days of feeding required during the hospital stay
• Hours of feeding missed while waiting for a chest radiograph due to displaced NGTs
• Number of NGT insertions
• Number of chest radiographs to confirm NGT position
• Bridling of NGTs
• Documented pressure sores related to the bridle or NGT, or referrals for wound management advice (Tissue Viability Team) as a consequence of the NGT bridle

Results

Of the 54 patients admitted, 31 had their NGTs bridled. Data were collected as in the first cycle, with individual notes analyzed on the online system (Table). Additionally, notes were reviewed for documentation of pressure sores related to NGT bridling, and the “requests” tab as well as the “noting” function were used to identify referrals for “Wound Management Advice” (Tissue Viability Review).

The average length of stay for this ICU cohort was 17.6 days. This reiterates the reliance on NGT feeding of patients admitted to the CCU. The results from this project can be summarized as follows: The use of NGT bridle kits leads to a significant reduction in the total number of NGTs a patient requires during intensive care. As a result, there is a significant reduction in the number of chest radiographs required to confirm NGT position. Feedings missed can also be reduced by using a bridle kit. These advantages all come with no additional cost.

On average, bridled patients required 1.3 NGTs, compared to 2.5 before bridles were introduced. The fewer NGTs inserted, the less chance of an NGT-associated injury occurring.

The number of chest radiographs required to confirm NGT position after resiting also fell, from 3.4 to 1.6. This has numerous advantages. There is a financial savings of £99 (US $133.04) per patient from the reduced number of chest x-rays. Although this does not offset the price of the bridle kit itself, there are other less easily quantifiable costs that are reduced. For instance, patients are highly catabolic during severe infection, and their predominant energy source comes from their feedings. Missed feedings are associated with longer length of stay in the ICU and in the hospital in general.⁹ Bridle kits have the potential to reduce the number of missed feedings by ensuring the NGT remains in the correct position.

Discussion

Many of the results are aligned with what is already known in the literature. A meta-analysis from 2014 concluded that dislodgment is reduced with the use of a bridle kit.⁶ This change is what underpins many of the advantages seen, as an NGT that stays in place means additional radiographs are not required and feeding is not delayed.

COVID-19 critical care patients are very fragile and are dependent on ventilators for the majority of their stay. They are often on very high levels of ventilator support and moving the patient can lead to desaturation or difficulties in ventilation. Therefore, reduction in any manual handling occurring as a result of the need for portable chest radiographs minimizes the chances of further negative events. Furthermore, nursing staff, along with the radiographers, are often the ones who must move these patients in order for the x-ray film to be placed behind the patient. This task is not easy, especially with limited personnel, and has the potential to cause injuries to both patients and staff members.

One concern noted was that bridles could cause increased incidence of pressure sores. In the patients represented in this study, only 1 suffered a pressure sore (grade 2) directly related to the bridle. A subpopulation of patients not bridled was also noted. This was significantly smaller than the main group; however, we had noted 2 incidences of pressure sores from their standard NGT and securement devices. Some studies have alluded to the potential for increased skin complications with bridle kits; however, studies looking specifically at kits using umbilical tape (as in this study) show no significant increase in skin damage.¹⁰ This leaves us confident that there is no increased risk of pressure sores related to the bridling of patients when umbilical tape is used with the bridle kit.

NGT bridles require training to insert safely. With the introduction of bridling, our hospital’s nursing staff underwent training in order to be proficient with the bridle kits. This comes with a time commitment, and, like other equipment usage, it takes time to build confidence. However, in this study, there were no concerns raised from nursing staff regarding difficulty of insertion or the time taken to do so.

Conclusion

The COVID-19 critical care population requires significant time on invasive ventilation and remains dependent on NGT feeding during this process. The risk of NGT dislodgment can be mitigated by using a bridle kit, as the number of NGT insertions a patient requires is significantly reduced. Not only does this reduce the risk of inadvertent misplacement but also has a cost savings, as well as increasing safety for staff and patients. From this study, the risk of pressure injuries is not significant. The benefit of NGT bridling may be extended to other non-COVID long-stay ICU patients.

Future research looking at the efficacy of bridle kits in larger patient groups will help confirm the benefits seen in this study and will also provide better information with regard to any long-term complications associated with bridles.

Corresponding author: Rajveer Atkar, MBBS, Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Birmingham B15 2GW, United Kingdom; [email protected].

Financial disclosures: None.

New cases of COVID-19 increased in children for the third consecutive week, while vaccinations among 5- to 11-year-olds continued to steadily increase, according to new data.

There were almost 142,000 new cases reported during the week of Nov. 12-18, marking an increase of 16% over the previous week and the 15th straight week with a weekly total over 100,000, the American Academy of Pediatrics and the Children’s Hospital Association said.

Regional data show that the Midwest has experienced the largest share of this latest surge, followed by the Northeast. Cases increased in the South during the week of Nov. 12-18 after holding steady over the previous 2 weeks, while new cases in the West dropped in the last week. At the state level, Maine, New Hampshire, and Vermont again reported the largest percent increases, with Michigan, Minnesota, and New Mexico also above average, the AAP and CHA said in their weekly COVID report.

Data from the Centers for Disease Control and Prevention show similar trends for both emergency department visits and hospital admissions, as both have risen in November after declines that began in late August and early September.

The cumulative number of pediatric cases is 6.77 million since the pandemic began, based on the AAP/CHA accounting of state cases, although Alabama, Nebraska, and Texas stopped reporting over the summer, suggesting the actual number is higher. The CDC puts the total number of COVID cases in children at 5.96 million, but there are age discrepancies between the CDC and the AAP/CHA’s state-based data.

The vaccine gap is closing

Vaccinations among the recently eligible 5- to 11-year-olds have steadily increased following a somewhat slow start. The initial pace was behind that of the 12- to 15-years-olds through the first postapproval week but has since closed the gap, based on data from the CDC’s COVID Data Tracker.

The tally of children who received at least one dose of the COVID vaccine among the 5- to 11-year-olds was behind the older group by almost 1.2 million on day 7 after the CDC’s Nov. 2 approval, but by day 18 the deficit was down to about 650,000, the CDC reported.

Altogether, just over 3 million children aged 5-11 have received at least one dose, which is 10.7% of that age group’s total population. Among children aged 12-17, the proportions are 60.7% with at least one dose and 51.1% at full vaccination. Children aged 5-11, who make up 8.7% of the total U.S. population, represented 42.8% of all vaccinations initiated over the 2 weeks ending Nov. 21, compared with 4.2% for those aged 12-17, the CDC said.

[email protected]

New cases of COVID-19 increased in children for the third consecutive week, while vaccinations among 5- to 11-year-olds continued to steadily increase, according to new data.

There were almost 142,000 new cases reported during the week of Nov. 12-18, marking an increase of 16% over the previous week and the 15th straight week with a weekly total over 100,000, the American Academy of Pediatrics and the Children’s Hospital Association said.

Regional data show that the Midwest has experienced the largest share of this latest surge, followed by the Northeast. Cases increased in the South during the week of Nov. 12-18 after holding steady over the previous 2 weeks, while new cases in the West dropped in the last week. At the state level, Maine, New Hampshire, and Vermont again reported the largest percent increases, with Michigan, Minnesota, and New Mexico also above average, the AAP and CHA said in their weekly COVID report.

Data from the Centers for Disease Control and Prevention show similar trends for both emergency department visits and hospital admissions, as both have risen in November after declines that began in late August and early September.

The cumulative number of pediatric cases is 6.77 million since the pandemic began, based on the AAP/CHA accounting of state cases, although Alabama, Nebraska, and Texas stopped reporting over the summer, suggesting the actual number is higher. The CDC puts the total number of COVID cases in children at 5.96 million, but there are age discrepancies between the CDC and the AAP/CHA’s state-based data.

The vaccine gap is closing

Vaccinations among the recently eligible 5- to 11-year-olds have steadily increased following a somewhat slow start. The initial pace was behind that of the 12- to 15-years-olds through the first postapproval week but has since closed the gap, based on data from the CDC’s COVID Data Tracker.

The tally of children who received at least one dose of the COVID vaccine among the 5- to 11-year-olds was behind the older group by almost 1.2 million on day 7 after the CDC’s Nov. 2 approval, but by day 18 the deficit was down to about 650,000, the CDC reported.

Altogether, just over 3 million children aged 5-11 have received at least one dose, which is 10.7% of that age group’s total population. Among children aged 12-17, the proportions are 60.7% with at least one dose and 51.1% at full vaccination. Children aged 5-11, who make up 8.7% of the total U.S. population, represented 42.8% of all vaccinations initiated over the 2 weeks ending Nov. 21, compared with 4.2% for those aged 12-17, the CDC said.

[email protected]

New cases of COVID-19 increased in children for the third consecutive week, while vaccinations among 5- to 11-year-olds continued to steadily increase, according to new data.

There were almost 142,000 new cases reported during the week of Nov. 12-18, marking an increase of 16% over the previous week and the 15th straight week with a weekly total over 100,000, the American Academy of Pediatrics and the Children’s Hospital Association said.

Regional data show that the Midwest has experienced the largest share of this latest surge, followed by the Northeast. Cases increased in the South during the week of Nov. 12-18 after holding steady over the previous 2 weeks, while new cases in the West dropped in the last week. At the state level, Maine, New Hampshire, and Vermont again reported the largest percent increases, with Michigan, Minnesota, and New Mexico also above average, the AAP and CHA said in their weekly COVID report.

Data from the Centers for Disease Control and Prevention show similar trends for both emergency department visits and hospital admissions, as both have risen in November after declines that began in late August and early September.

The cumulative number of pediatric cases is 6.77 million since the pandemic began, based on the AAP/CHA accounting of state cases, although Alabama, Nebraska, and Texas stopped reporting over the summer, suggesting the actual number is higher. The CDC puts the total number of COVID cases in children at 5.96 million, but there are age discrepancies between the CDC and the AAP/CHA’s state-based data.

The vaccine gap is closing

Vaccinations among the recently eligible 5- to 11-year-olds have steadily increased following a somewhat slow start. The initial pace was behind that of the 12- to 15-years-olds through the first postapproval week but has since closed the gap, based on data from the CDC’s COVID Data Tracker.

The tally of children who received at least one dose of the COVID vaccine among the 5- to 11-year-olds was behind the older group by almost 1.2 million on day 7 after the CDC’s Nov. 2 approval, but by day 18 the deficit was down to about 650,000, the CDC reported.

Altogether, just over 3 million children aged 5-11 have received at least one dose, which is 10.7% of that age group’s total population. Among children aged 12-17, the proportions are 60.7% with at least one dose and 51.1% at full vaccination. Children aged 5-11, who make up 8.7% of the total U.S. population, represented 42.8% of all vaccinations initiated over the 2 weeks ending Nov. 21, compared with 4.2% for those aged 12-17, the CDC said.

[email protected]

Because hepatitis C virus (HCV) infection is typically asymptomatic, its presence can easily be overlooked without appropriate screening efforts. For those screening efforts to be effective, they must keep pace with the changing demographic face of this increasingly prevalent but treatable disease.

Perhaps the most dramatic shift in HCV demographics in recent years has been the increase of infections among those born after 1965, a trend primarily driven by the opioid epidemic. In addition, data from the National Notifiable Diseases Surveillance System show that cases of diagnosed HCV doubled among women of childbearing age from 2006 to 2014, with new infections in younger women surpassing those in older age groups.

With such trends in mind, the Centers for Disease Control and Prevention broadened their recommendations regarding HCV in 2020 to include one-time testing in all adults aged 18 years and older and screening of all pregnant women during each pregnancy, except where the prevalence of infection is less than 0.1%, a threshold that no state has yet achieved.

The US Preventive Services Task Force (USPSTF) subsequently followed suit in their own recommendations.

The American Association for the Study of Liver Diseases/Infectious Diseases Society of America have long advocated for extensive expansion in their screening recommendations for HCV, including pregnancy.

Although the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine did not immediately adopt these recommendations, they have since endorsed them in May 2021 and June 2021, respectively.
 

The hepatologist perspective

As a practicing hepatologist, this seems like an uncontroversial recommendation. Obstetricians already screen for hepatitis B virus in each pregnancy. It should be easy to add HCV testing to the same lab testing.

Risk-based screening has repeatedly been demonstrated to be ineffective. It should be easier to test all women than to ask prying questions about high-risk behaviors.

Given the increase of injection drug use and resultant HCV infections in women of childbearing age, this seems like a perfect opportunity to identify chronically infected women and counsel them on transmission and cure. And pregnancy is also unique in that it is a time of near-universal health coverage.

Let’s address some of the operational issues.

The diagnostic cascade for HCV can be made very easy. HCV antibody testing is our standard screening test and, when positive, can automatically reflex to HCV polymerase chain reaction (PCR), the diagnostic test. Thus, with one blood sample, you can both screen for and diagnose infection.

Current guidelines do not recommend treating HCV during pregnancy, although therapy can be considered on an individual basis. Linkage to a knowledgeable provider who can discuss transmission and treatment, as well as assess the stage of liver injury, should decrease the burden on the ob.gyn.

The impact on pregnancy is marginal. HCV should not change either the mode of delivery or the decision to breastfeed. The AASLD/IDSA guidance outlines only four recommendations for monitoring during pregnancy:

• Obtain HCV RNA to see whether the infection is active and assess liver function at initiation of prenatal care.
• Prenatal care should be tailored to the pregnancy. There is no modification recommended to decrease mother-to-child transmission (MTCT).
• Be aware that intrahepatic is more common with HCV.
• Women with have a higher rate of adverse outcomes and should be linked to a high-risk obstetrics specialist.

But of course, what seems easy to one specialist may not be true of another. With that in mind, let’s hear the ob.gyn. perspective on these updated screening recommendations.
 

The ob.gyn. perspective

Recent guidelines from the CDC, ACOG, and SMFM recommend universal screening for HCV in all pregnant women. The increased availability of highly effective antiviral regimens makes universal screening a logical strategy, especially to identify candidates for this curative treatment. What is questionable, however, is the recommended timing by which this screening should take place.

HCV screening during pregnancy, as currently recommended, provides no immediate benefit for the pregnant woman or the fetus/neonate, given that antiviral treatments have not been approved during gestation, and there are no known measures that decrease MTCT or change routine perinatal care.

We also must not forget that a significant proportion of women in the United States, particularly those with limited resources, do not receive prenatal care at all. Most of them, however, will present to a hospital for delivery. Consequently, compliance with screening might be higher if performed at the time of delivery rather than antepartum.

Deferring screening until the intrapartum or immediate postpartum period, at least until antiviral treatment during pregnancy becomes a reality, was discussed. The rationale was that this approach might obviate the need to deal with the unintended consequences and burden of testing for HCV during pregnancy. Ultimately, ACOG and SMFM fell in line with the CDC recommendations.

Despite the lack of robust evidence regarding the risk for MTCT associated with commonly performed obstetric procedures (for example, genetic amniocentesis, artificial rupture of the membranes during labor, placement of an intrauterine pressure catheter), clinicians may be reluctant to perform them in HCV-infected women, resulting in potential deviations from the obstetric standard of care.

Similarly, it is likely that patients may choose to have a cesarean delivery for the sole purpose of decreasing MTCT, despite the lack of evidence for this. Such ill-advised patient-driven decisions are increasingly likely in the current environment, where social media can rapidly disseminate misinformation.
 

Implications for pediatric patients

One cannot isolate HCV screening in pregnancy from the consequences that may potentially occur as part of the infant’s transition to the care of a pediatrician.

Even though MTCT is estimated to occur in just 5%-15% of cases, all children born to HCV viremic mothers should be screened for HCV.

Traditionally, screening for HCV antibodies occurred after 18 months of age. In those who test positive, HCV PCR testing is recommended at 3 years. However, this algorithm is being called into question because only approximately one-third of infants are successfully screened.

HCV RNA testing in the first year after birth has been suggested. However, even proponents of this approach concur that all management decisions should be deferred until after the age of 3 years, when medications are approved for pediatric use.

In addition, HCV testing would be required again before considering therapy because children have higher rates of spontaneous clearance.
 

Seeking consensus beyond the controversy

Controversy remains surrounding the most recent update to the HCV screening guidelines. The current recommendation to screen during pregnancy cannot modify the risk for MTCT, has no impact on decisions regarding mode of delivery or breastfeeding, and could potentially cause harm by making obstetricians defer necessary invasive procedures even though there are no data linking them to an increase in MTCT.

Yet after extensive debate, the CDC, USPSTF, AASLD/IDSA, ACOG, and SMFM all developed their current recommendations to initiate HCV screening during pregnancy. To make this successful, screening algorithms need to be simple and consistent across all society recommendations.

HCV antibody testing should always reflex to the diagnostic test (HCV PCR) to allow confirmation in those who test positive without requiring an additional blood test. Viremic mothers (those who are HCV positive on PCR) should be linked to a provider who can discuss prognosis, transmission, and treatment. The importance of screening the infant also must be communicated to the parents and pediatrician alike.

Dr. Reau has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Gilead, Arbutus, Intercept, and Salix; received research grants from AbbVie and Gilead; and received income from AASLD. Dr. Pacheco disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Because hepatitis C virus (HCV) infection is typically asymptomatic, its presence can easily be overlooked without appropriate screening efforts. For those screening efforts to be effective, they must keep pace with the changing demographic face of this increasingly prevalent but treatable disease.

Perhaps the most dramatic shift in HCV demographics in recent years has been the increase of infections among those born after 1965, a trend primarily driven by the opioid epidemic. In addition, data from the National Notifiable Diseases Surveillance System show that cases of diagnosed HCV doubled among women of childbearing age from 2006 to 2014, with new infections in younger women surpassing those in older age groups.

With such trends in mind, the Centers for Disease Control and Prevention broadened their recommendations regarding HCV in 2020 to include one-time testing in all adults aged 18 years and older and screening of all pregnant women during each pregnancy, except where the prevalence of infection is less than 0.1%, a threshold that no state has yet achieved.

The US Preventive Services Task Force (USPSTF) subsequently followed suit in their own recommendations.

The American Association for the Study of Liver Diseases/Infectious Diseases Society of America have long advocated for extensive expansion in their screening recommendations for HCV, including pregnancy.

Although the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine did not immediately adopt these recommendations, they have since endorsed them in May 2021 and June 2021, respectively.
 

The hepatologist perspective

As a practicing hepatologist, this seems like an uncontroversial recommendation. Obstetricians already screen for hepatitis B virus in each pregnancy. It should be easy to add HCV testing to the same lab testing.

Risk-based screening has repeatedly been demonstrated to be ineffective. It should be easier to test all women than to ask prying questions about high-risk behaviors.

Given the increase of injection drug use and resultant HCV infections in women of childbearing age, this seems like a perfect opportunity to identify chronically infected women and counsel them on transmission and cure. And pregnancy is also unique in that it is a time of near-universal health coverage.

Let’s address some of the operational issues.

The diagnostic cascade for HCV can be made very easy. HCV antibody testing is our standard screening test and, when positive, can automatically reflex to HCV polymerase chain reaction (PCR), the diagnostic test. Thus, with one blood sample, you can both screen for and diagnose infection.

Current guidelines do not recommend treating HCV during pregnancy, although therapy can be considered on an individual basis. Linkage to a knowledgeable provider who can discuss transmission and treatment, as well as assess the stage of liver injury, should decrease the burden on the ob.gyn.

The impact on pregnancy is marginal. HCV should not change either the mode of delivery or the decision to breastfeed. The AASLD/IDSA guidance outlines only four recommendations for monitoring during pregnancy:

• Obtain HCV RNA to see whether the infection is active and assess liver function at initiation of prenatal care.
• Prenatal care should be tailored to the pregnancy. There is no modification recommended to decrease mother-to-child transmission (MTCT).
• Be aware that intrahepatic is more common with HCV.
• Women with have a higher rate of adverse outcomes and should be linked to a high-risk obstetrics specialist.

But of course, what seems easy to one specialist may not be true of another. With that in mind, let’s hear the ob.gyn. perspective on these updated screening recommendations.
 

The ob.gyn. perspective

Recent guidelines from the CDC, ACOG, and SMFM recommend universal screening for HCV in all pregnant women. The increased availability of highly effective antiviral regimens makes universal screening a logical strategy, especially to identify candidates for this curative treatment. What is questionable, however, is the recommended timing by which this screening should take place.

HCV screening during pregnancy, as currently recommended, provides no immediate benefit for the pregnant woman or the fetus/neonate, given that antiviral treatments have not been approved during gestation, and there are no known measures that decrease MTCT or change routine perinatal care.

We also must not forget that a significant proportion of women in the United States, particularly those with limited resources, do not receive prenatal care at all. Most of them, however, will present to a hospital for delivery. Consequently, compliance with screening might be higher if performed at the time of delivery rather than antepartum.

Deferring screening until the intrapartum or immediate postpartum period, at least until antiviral treatment during pregnancy becomes a reality, was discussed. The rationale was that this approach might obviate the need to deal with the unintended consequences and burden of testing for HCV during pregnancy. Ultimately, ACOG and SMFM fell in line with the CDC recommendations.

Despite the lack of robust evidence regarding the risk for MTCT associated with commonly performed obstetric procedures (for example, genetic amniocentesis, artificial rupture of the membranes during labor, placement of an intrauterine pressure catheter), clinicians may be reluctant to perform them in HCV-infected women, resulting in potential deviations from the obstetric standard of care.

Similarly, it is likely that patients may choose to have a cesarean delivery for the sole purpose of decreasing MTCT, despite the lack of evidence for this. Such ill-advised patient-driven decisions are increasingly likely in the current environment, where social media can rapidly disseminate misinformation.
 

Implications for pediatric patients

One cannot isolate HCV screening in pregnancy from the consequences that may potentially occur as part of the infant’s transition to the care of a pediatrician.

Even though MTCT is estimated to occur in just 5%-15% of cases, all children born to HCV viremic mothers should be screened for HCV.

Traditionally, screening for HCV antibodies occurred after 18 months of age. In those who test positive, HCV PCR testing is recommended at 3 years. However, this algorithm is being called into question because only approximately one-third of infants are successfully screened.

HCV RNA testing in the first year after birth has been suggested. However, even proponents of this approach concur that all management decisions should be deferred until after the age of 3 years, when medications are approved for pediatric use.

In addition, HCV testing would be required again before considering therapy because children have higher rates of spontaneous clearance.
 

Seeking consensus beyond the controversy

Controversy remains surrounding the most recent update to the HCV screening guidelines. The current recommendation to screen during pregnancy cannot modify the risk for MTCT, has no impact on decisions regarding mode of delivery or breastfeeding, and could potentially cause harm by making obstetricians defer necessary invasive procedures even though there are no data linking them to an increase in MTCT.

Yet after extensive debate, the CDC, USPSTF, AASLD/IDSA, ACOG, and SMFM all developed their current recommendations to initiate HCV screening during pregnancy. To make this successful, screening algorithms need to be simple and consistent across all society recommendations.

HCV antibody testing should always reflex to the diagnostic test (HCV PCR) to allow confirmation in those who test positive without requiring an additional blood test. Viremic mothers (those who are HCV positive on PCR) should be linked to a provider who can discuss prognosis, transmission, and treatment. The importance of screening the infant also must be communicated to the parents and pediatrician alike.

Dr. Reau has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Gilead, Arbutus, Intercept, and Salix; received research grants from AbbVie and Gilead; and received income from AASLD. Dr. Pacheco disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Because hepatitis C virus (HCV) infection is typically asymptomatic, its presence can easily be overlooked without appropriate screening efforts. For those screening efforts to be effective, they must keep pace with the changing demographic face of this increasingly prevalent but treatable disease.

Perhaps the most dramatic shift in HCV demographics in recent years has been the increase of infections among those born after 1965, a trend primarily driven by the opioid epidemic. In addition, data from the National Notifiable Diseases Surveillance System show that cases of diagnosed HCV doubled among women of childbearing age from 2006 to 2014, with new infections in younger women surpassing those in older age groups.

With such trends in mind, the Centers for Disease Control and Prevention broadened their recommendations regarding HCV in 2020 to include one-time testing in all adults aged 18 years and older and screening of all pregnant women during each pregnancy, except where the prevalence of infection is less than 0.1%, a threshold that no state has yet achieved.

The US Preventive Services Task Force (USPSTF) subsequently followed suit in their own recommendations.

The American Association for the Study of Liver Diseases/Infectious Diseases Society of America have long advocated for extensive expansion in their screening recommendations for HCV, including pregnancy.

Although the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine did not immediately adopt these recommendations, they have since endorsed them in May 2021 and June 2021, respectively.
 

The hepatologist perspective

As a practicing hepatologist, this seems like an uncontroversial recommendation. Obstetricians already screen for hepatitis B virus in each pregnancy. It should be easy to add HCV testing to the same lab testing.

Risk-based screening has repeatedly been demonstrated to be ineffective. It should be easier to test all women than to ask prying questions about high-risk behaviors.

Given the increase of injection drug use and resultant HCV infections in women of childbearing age, this seems like a perfect opportunity to identify chronically infected women and counsel them on transmission and cure. And pregnancy is also unique in that it is a time of near-universal health coverage.

Let’s address some of the operational issues.

The diagnostic cascade for HCV can be made very easy. HCV antibody testing is our standard screening test and, when positive, can automatically reflex to HCV polymerase chain reaction (PCR), the diagnostic test. Thus, with one blood sample, you can both screen for and diagnose infection.

Current guidelines do not recommend treating HCV during pregnancy, although therapy can be considered on an individual basis. Linkage to a knowledgeable provider who can discuss transmission and treatment, as well as assess the stage of liver injury, should decrease the burden on the ob.gyn.

The impact on pregnancy is marginal. HCV should not change either the mode of delivery or the decision to breastfeed. The AASLD/IDSA guidance outlines only four recommendations for monitoring during pregnancy:

• Obtain HCV RNA to see whether the infection is active and assess liver function at initiation of prenatal care.
• Prenatal care should be tailored to the pregnancy. There is no modification recommended to decrease mother-to-child transmission (MTCT).
• Be aware that intrahepatic is more common with HCV.
• Women with have a higher rate of adverse outcomes and should be linked to a high-risk obstetrics specialist.

But of course, what seems easy to one specialist may not be true of another. With that in mind, let’s hear the ob.gyn. perspective on these updated screening recommendations.
 

The ob.gyn. perspective

Recent guidelines from the CDC, ACOG, and SMFM recommend universal screening for HCV in all pregnant women. The increased availability of highly effective antiviral regimens makes universal screening a logical strategy, especially to identify candidates for this curative treatment. What is questionable, however, is the recommended timing by which this screening should take place.

HCV screening during pregnancy, as currently recommended, provides no immediate benefit for the pregnant woman or the fetus/neonate, given that antiviral treatments have not been approved during gestation, and there are no known measures that decrease MTCT or change routine perinatal care.

We also must not forget that a significant proportion of women in the United States, particularly those with limited resources, do not receive prenatal care at all. Most of them, however, will present to a hospital for delivery. Consequently, compliance with screening might be higher if performed at the time of delivery rather than antepartum.

Deferring screening until the intrapartum or immediate postpartum period, at least until antiviral treatment during pregnancy becomes a reality, was discussed. The rationale was that this approach might obviate the need to deal with the unintended consequences and burden of testing for HCV during pregnancy. Ultimately, ACOG and SMFM fell in line with the CDC recommendations.

Despite the lack of robust evidence regarding the risk for MTCT associated with commonly performed obstetric procedures (for example, genetic amniocentesis, artificial rupture of the membranes during labor, placement of an intrauterine pressure catheter), clinicians may be reluctant to perform them in HCV-infected women, resulting in potential deviations from the obstetric standard of care.

Similarly, it is likely that patients may choose to have a cesarean delivery for the sole purpose of decreasing MTCT, despite the lack of evidence for this. Such ill-advised patient-driven decisions are increasingly likely in the current environment, where social media can rapidly disseminate misinformation.
 

Implications for pediatric patients

One cannot isolate HCV screening in pregnancy from the consequences that may potentially occur as part of the infant’s transition to the care of a pediatrician.

Even though MTCT is estimated to occur in just 5%-15% of cases, all children born to HCV viremic mothers should be screened for HCV.

Traditionally, screening for HCV antibodies occurred after 18 months of age. In those who test positive, HCV PCR testing is recommended at 3 years. However, this algorithm is being called into question because only approximately one-third of infants are successfully screened.

HCV RNA testing in the first year after birth has been suggested. However, even proponents of this approach concur that all management decisions should be deferred until after the age of 3 years, when medications are approved for pediatric use.

In addition, HCV testing would be required again before considering therapy because children have higher rates of spontaneous clearance.
 

Seeking consensus beyond the controversy

Controversy remains surrounding the most recent update to the HCV screening guidelines. The current recommendation to screen during pregnancy cannot modify the risk for MTCT, has no impact on decisions regarding mode of delivery or breastfeeding, and could potentially cause harm by making obstetricians defer necessary invasive procedures even though there are no data linking them to an increase in MTCT.

Yet after extensive debate, the CDC, USPSTF, AASLD/IDSA, ACOG, and SMFM all developed their current recommendations to initiate HCV screening during pregnancy. To make this successful, screening algorithms need to be simple and consistent across all society recommendations.

HCV antibody testing should always reflex to the diagnostic test (HCV PCR) to allow confirmation in those who test positive without requiring an additional blood test. Viremic mothers (those who are HCV positive on PCR) should be linked to a provider who can discuss prognosis, transmission, and treatment. The importance of screening the infant also must be communicated to the parents and pediatrician alike.

Dr. Reau has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Gilead, Arbutus, Intercept, and Salix; received research grants from AbbVie and Gilead; and received income from AASLD. Dr. Pacheco disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Case

A 72-year-old woman with type 2 diabetes mellitus presents with acute dysuria, fever, and flank pain. She had a urinary tract infection (UTI) 3 months prior treated with nitrofurantoin. Temperature is 102° F, heart rate 112 beats per minute, and the remainder of vital signs are normal. She has left costovertebral angle tenderness. Urine microscopy shows 70 WBCs per high power field and bacteria. Is this urinary tract infection complicated?

Background

The urinary tract is divided into the upper tract, which includes the kidneys and ureters, and the lower urinary tract, which includes the bladder, urethra, and prostate. Infection of the lower urinary tract is referred to as cystitis while infection of the upper urinary tract is pyelonephritis. A UTI is the colonization of pathogen(s) within the urinary system that causes an inflammatory response resulting in symptoms and requiring treatment. UTIs occur when there is reduced urine flow, an increase in colonization risk, and when there are factors that facilitate ascent such as catheterization or incontinence.

There are an estimated 150 million cases of UTIs worldwide per year, accounting for $6 billion in health care expenditures.¹ In the inpatient setting, about 40% of nosocomial infections are associated with urinary catheters. This equates to about 1 million catheter-associated UTIs per year in the United States, and up to 40% of hospital gram-negative bacteremia per year are caused by UTIs.¹

UTIs are often classified as either uncomplicated or complicated infections, which can influence the depth of management. UTIs have a wide spectrum of symptoms and can manifest anywhere from mild dysuria treated successfully with outpatient antibiotics to florid sepsis. Uncomplicated simple cystitis is often treated as an outpatient with oral nitrofurantoin or trimethoprim-sulfamethoxazole.² Complicated UTIs are treated with broader antimicrobial coverage, and depending on severity, could require intravenous antibiotics. Many factors affect how a UTI manifests and determining whether an infection is “uncomplicated” or “complicated” is an important first step in guiding management. Unfortunately, there are differing classifications of “complicated” UTIs, making it a complicated issue itself. We outline two common approaches.
 

Anatomic approach

A commonly recognized definition is from the American Urological Association, which states that complicated UTIs are symptomatic cases associated with the presence of “underlying, predisposing conditions and not necessarily clinical severity, invasiveness, or complications.”³ These factors include structural or functional urinary tract abnormalities or urinary instrumentation (see Table 1). These predisposing conditions can increase microbial colonization and decrease therapy efficacy, thus increasing the frequency of infection and relapse.

This population of patients is at high risk of infections with more resistant bacteria such as extended-spectrum beta-lactamase (ESBL) producing Escherichia coli since they often lack the natural genitourinary barriers to infection. In addition, these patients more often undergo multiple antibiotic courses for their frequent infections, which also contributes to their risk of ESBL infections. Genitourinary abnormalities interfere with normal voiding, resulting in impaired flushing of bacteria. For instance, obstruction inhibits complete urinary drainage and increases the persistence of bacteria in biofilms, especially if there are stones or indwelling devices present. Biofilms usually contain a high concentration of organisms including Proteus mirabilis, Morgenella morganii, and Providencia spp.⁴ Keep in mind that, if there is an obstruction, the urinalysis might be without pyuria or bacteriuria.

Instrumentation increases infection risks through the direct introduction of bacteria into the genitourinary tract. Despite the efforts in maintaining sterility in urinary catheter placement, catheters provide a nidus for infection. Catheter-associated UTI (CAUTI) is defined by the Infectious Disease Society of America as UTIs that occur in patients with an indwelling catheter or who had a catheter removed for less than 48 hours who develop urinary symptoms and cultures positive for uropathogenic bacteria.⁴ Studies show that in general, patients with indwelling catheters will develop bacteriuria over time, with 10%-25% eventually developing symptoms.
 

Severity approach

There are other schools of thought that categorize uncomplicated versus complicated UTIs based on the severity of presentation (see Table 2). An uncomplicated UTI would be classified as symptoms and signs of simple cystitis limited to dysuria, frequency, urgency, and suprapubic pain. Using a symptom severity approach, systemic findings such as fever, chills, emesis, flank pain, costovertebral angle tenderness, or other findings of sepsis would be classified as a complicated UTI. These systemic findings would suggest an extension of infection beyond the bladder.

The argument for a symptomatic-based approach of classification is that the severity of symptoms should dictate the degree of management. Not all UTIs in the anatomic approach are severe. In fact, populations that are considered at risk for complicated UTIs by the AUA guidelines in Table 1 often have mild symptomatic cystitis or asymptomatic bacteriuria. Asymptomatic bacteriuria is the colonization of organisms in the urinary tract without active infection. For instance, bacteriuria is present in almost 100% of people with chronic indwelling catheters, 30%-40% of neurogenic bladder requiring intermittent catheterization, and 50% of elderly nursing home residents.⁴ Not all bacteriuria triggers enough of an inflammatory response to cause symptoms that require treatment.
 

Ultimate clinical judgment

Although there are multiple different society recommendations in distinguishing uncomplicated versus complicated UTIs, considering both anatomical and severity risk factors can better aid in clinical decision-making rather than abiding by one classification method alone.

Uncomplicated UTIs from the AUA guidelines can cause severe infections that might require longer courses of broad-spectrum antibiotics. On the other hand, people with anatomic abnormalities can present with mild symptoms that can be treated with a narrow-spectrum antibiotic for a standard time course. Recognizing the severity of the infection and using clinical judgment aids in antibiotic stewardship.

Although the existence of algorithmic approaches can help guide clinical judgment, accounting for the spectrum of host and bacterial factors should ultimately determine the complexity of the disease and management.³ Using clinical suspicion to determine when a UTI should be treated as a complicated infection can ensure effective treatment and decrease the likelihood of sepsis, renal scarring, or end-stage disease.⁵

Back to the case

The case presents an elderly woman with diabetes presenting with sepsis from a UTI. Because of a normal urinary tract and no prior instrumentation, by the AUA definition, she would be classified as an uncomplicated UTI; however, we would classify her as a complicated UTI based on the severity of her presentation. She has a fever, tachycardia, flank pain, and costovertebral angle tenderness that are evidence of infection extending beyond the bladder. She has sepsis warranting inpatient management. Prior urine culture results could aid in determining empiric treatment while waiting for new cultures. In her case, an intravenous antibiotic with broad gram-negative coverage such as ceftriaxone would be appropriate.

Bottom line

There are multiple interpretations of complicated UTIs including both an anatomical and severity approach. Clinical judgment regarding infection severity should determine the depth of management.

Dr. Vu is a hospitalist at the University of Kentucky, Lexington. Dr. Gray is a hospitalist at the University of Kentucky and the Lexington Veterans Affairs Medical Center.

References

1. Folk CS. AUA Core Curriculum: Urinary Tract Infection (Adult). 2021 Mar 1. https://university.auanet.org/core_topic.cfm?coreid=92.

2. Gupta K et al. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: A 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011 Mar 1;52(5):e103-20. doi: 10.1093/cid/ciq257.

3. Johnson JR. Definition of Complicated Urinary Tract Infection. Clin Infect Dis. 2017 February 15;64(4):529. doi: 10.1093/cid/ciw751.

4. Nicolle LE, AMMI Canada Guidelines Committee. Complicated urinary tract infection in adults. Can J Infect Dis Med Microbiol. 2005;16(6):349-60. doi: 10.1155/2005/385768.

5. Melekos MD and Naber KG. Complicated urinary tract infections. Int J Antimicrob Agents. 2000;15(4):247-56. doi: 10.1016/s0924-8579(00)00168-0.
 

Key points

• The anatomical approach to defining complicated UTIs considers the presence of underlying, predisposing conditions such as structurally or functionally abnormal genitourinary tract or urinary instrumentation or foreign bodies.
• The severity approach to defining complicated UTIs considers the severity of presentation including the presence of systemic manifestations.
• Both approaches should consider populations that are at risk for recurrent or multidrug-resistant infections and infections that can lead to high morbidity.
• Either approach can be used as a guide, but neither should replace clinical suspicion and judgment in determining the depth of treatment.

Additional reading

Choe HS et al. Summary of the UAA‐AAUS guidelines for urinary tract infections. Int J Urol. 2018 Mar;25(3):175-85. doi:10.1111/iju.13493.

Nicolle LE et al. Infectious Diseases Society of America Guidelines for the Diagnosis and Treatment of Asymptomatic Bacteriuria in Adults. Clin Infect Dis. 2005 Mar;40(5):643-54. doi: 10.1086/427507.

Wagenlehner FME et al. Epidemiology, definition and treatment of complicated urinary tract infections. Nat Rev Urol. 2020 Oct;17:586-600. doi:10.1038/s41585-020-0362-4.

Wallace DW et al. Urinalysis: A simple test with complicated interpretation. J Urgent Care Med. 2020 July-Aug;14(10):11-4.

Quiz

A 68-year-old woman with type 2 diabetes mellitus presents to the emergency department with acute fever, chills, dysuria, frequency, and suprapubic pain. She has associated nausea, malaise, and fatigue. She takes metformin and denies recent antibiotic use. Her temperature is 102.8° F, heart rate 118 beats per minute, blood pressure 118/71 mm Hg, and her respiratory rate is 24 breaths per minute. She is ill-appearing and has mild suprapubic tenderness. White blood cell count is 18 k/mcL. Urinalysis is positive for leukocyte esterase, nitrites, and bacteria. Urine microscopy has 120 white blood cells per high power field. What is the most appropriate treatment?

A. Azithromycin

B. Ceftriaxone

C. Cefepime and vancomycin

D. Nitrofurantoin

The answer is B. The patient presents with sepsis secondary to a urinary tract infection. Using the anatomic approach this would be classified as uncomplicated. Using the severity approach, this would be classified as a complicated urinary tract infection. With fever, chills, and signs of sepsis, it’s likely her infection extends beyond the bladder. Given the severity of her presentation, we’d favor treating her as a complicated urinary tract infection with intravenous ceftriaxone. There is no suggestion of resistance or additional MRSA risk factors requiring intravenous vancomycin or cefepime. Nitrofurantoin, although a first-line treatment for uncomplicated cystitis, would not be appropriate if there is suspicion infection extends beyond the bladder. Azithromycin is a first-line option for chlamydia trachomatis, but not a urinary tract infection.




 

Case

A 72-year-old woman with type 2 diabetes mellitus presents with acute dysuria, fever, and flank pain. She had a urinary tract infection (UTI) 3 months prior treated with nitrofurantoin. Temperature is 102° F, heart rate 112 beats per minute, and the remainder of vital signs are normal. She has left costovertebral angle tenderness. Urine microscopy shows 70 WBCs per high power field and bacteria. Is this urinary tract infection complicated?

Background

The urinary tract is divided into the upper tract, which includes the kidneys and ureters, and the lower urinary tract, which includes the bladder, urethra, and prostate. Infection of the lower urinary tract is referred to as cystitis while infection of the upper urinary tract is pyelonephritis. A UTI is the colonization of pathogen(s) within the urinary system that causes an inflammatory response resulting in symptoms and requiring treatment. UTIs occur when there is reduced urine flow, an increase in colonization risk, and when there are factors that facilitate ascent such as catheterization or incontinence.

There are an estimated 150 million cases of UTIs worldwide per year, accounting for $6 billion in health care expenditures.¹ In the inpatient setting, about 40% of nosocomial infections are associated with urinary catheters. This equates to about 1 million catheter-associated UTIs per year in the United States, and up to 40% of hospital gram-negative bacteremia per year are caused by UTIs.¹

UTIs are often classified as either uncomplicated or complicated infections, which can influence the depth of management. UTIs have a wide spectrum of symptoms and can manifest anywhere from mild dysuria treated successfully with outpatient antibiotics to florid sepsis. Uncomplicated simple cystitis is often treated as an outpatient with oral nitrofurantoin or trimethoprim-sulfamethoxazole.² Complicated UTIs are treated with broader antimicrobial coverage, and depending on severity, could require intravenous antibiotics. Many factors affect how a UTI manifests and determining whether an infection is “uncomplicated” or “complicated” is an important first step in guiding management. Unfortunately, there are differing classifications of “complicated” UTIs, making it a complicated issue itself. We outline two common approaches.
 

Anatomic approach

A commonly recognized definition is from the American Urological Association, which states that complicated UTIs are symptomatic cases associated with the presence of “underlying, predisposing conditions and not necessarily clinical severity, invasiveness, or complications.”³ These factors include structural or functional urinary tract abnormalities or urinary instrumentation (see Table 1). These predisposing conditions can increase microbial colonization and decrease therapy efficacy, thus increasing the frequency of infection and relapse.

This population of patients is at high risk of infections with more resistant bacteria such as extended-spectrum beta-lactamase (ESBL) producing Escherichia coli since they often lack the natural genitourinary barriers to infection. In addition, these patients more often undergo multiple antibiotic courses for their frequent infections, which also contributes to their risk of ESBL infections. Genitourinary abnormalities interfere with normal voiding, resulting in impaired flushing of bacteria. For instance, obstruction inhibits complete urinary drainage and increases the persistence of bacteria in biofilms, especially if there are stones or indwelling devices present. Biofilms usually contain a high concentration of organisms including Proteus mirabilis, Morgenella morganii, and Providencia spp.⁴ Keep in mind that, if there is an obstruction, the urinalysis might be without pyuria or bacteriuria.

Instrumentation increases infection risks through the direct introduction of bacteria into the genitourinary tract. Despite the efforts in maintaining sterility in urinary catheter placement, catheters provide a nidus for infection. Catheter-associated UTI (CAUTI) is defined by the Infectious Disease Society of America as UTIs that occur in patients with an indwelling catheter or who had a catheter removed for less than 48 hours who develop urinary symptoms and cultures positive for uropathogenic bacteria.⁴ Studies show that in general, patients with indwelling catheters will develop bacteriuria over time, with 10%-25% eventually developing symptoms.
 

Severity approach

There are other schools of thought that categorize uncomplicated versus complicated UTIs based on the severity of presentation (see Table 2). An uncomplicated UTI would be classified as symptoms and signs of simple cystitis limited to dysuria, frequency, urgency, and suprapubic pain. Using a symptom severity approach, systemic findings such as fever, chills, emesis, flank pain, costovertebral angle tenderness, or other findings of sepsis would be classified as a complicated UTI. These systemic findings would suggest an extension of infection beyond the bladder.

The argument for a symptomatic-based approach of classification is that the severity of symptoms should dictate the degree of management. Not all UTIs in the anatomic approach are severe. In fact, populations that are considered at risk for complicated UTIs by the AUA guidelines in Table 1 often have mild symptomatic cystitis or asymptomatic bacteriuria. Asymptomatic bacteriuria is the colonization of organisms in the urinary tract without active infection. For instance, bacteriuria is present in almost 100% of people with chronic indwelling catheters, 30%-40% of neurogenic bladder requiring intermittent catheterization, and 50% of elderly nursing home residents.⁴ Not all bacteriuria triggers enough of an inflammatory response to cause symptoms that require treatment.
 

Ultimate clinical judgment

Although there are multiple different society recommendations in distinguishing uncomplicated versus complicated UTIs, considering both anatomical and severity risk factors can better aid in clinical decision-making rather than abiding by one classification method alone.

Uncomplicated UTIs from the AUA guidelines can cause severe infections that might require longer courses of broad-spectrum antibiotics. On the other hand, people with anatomic abnormalities can present with mild symptoms that can be treated with a narrow-spectrum antibiotic for a standard time course. Recognizing the severity of the infection and using clinical judgment aids in antibiotic stewardship.

Although the existence of algorithmic approaches can help guide clinical judgment, accounting for the spectrum of host and bacterial factors should ultimately determine the complexity of the disease and management.³ Using clinical suspicion to determine when a UTI should be treated as a complicated infection can ensure effective treatment and decrease the likelihood of sepsis, renal scarring, or end-stage disease.⁵

Back to the case

The case presents an elderly woman with diabetes presenting with sepsis from a UTI. Because of a normal urinary tract and no prior instrumentation, by the AUA definition, she would be classified as an uncomplicated UTI; however, we would classify her as a complicated UTI based on the severity of her presentation. She has a fever, tachycardia, flank pain, and costovertebral angle tenderness that are evidence of infection extending beyond the bladder. She has sepsis warranting inpatient management. Prior urine culture results could aid in determining empiric treatment while waiting for new cultures. In her case, an intravenous antibiotic with broad gram-negative coverage such as ceftriaxone would be appropriate.

Bottom line

There are multiple interpretations of complicated UTIs including both an anatomical and severity approach. Clinical judgment regarding infection severity should determine the depth of management.

Dr. Vu is a hospitalist at the University of Kentucky, Lexington. Dr. Gray is a hospitalist at the University of Kentucky and the Lexington Veterans Affairs Medical Center.

References

1. Folk CS. AUA Core Curriculum: Urinary Tract Infection (Adult). 2021 Mar 1. https://university.auanet.org/core_topic.cfm?coreid=92.

2. Gupta K et al. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: A 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011 Mar 1;52(5):e103-20. doi: 10.1093/cid/ciq257.

3. Johnson JR. Definition of Complicated Urinary Tract Infection. Clin Infect Dis. 2017 February 15;64(4):529. doi: 10.1093/cid/ciw751.

4. Nicolle LE, AMMI Canada Guidelines Committee. Complicated urinary tract infection in adults. Can J Infect Dis Med Microbiol. 2005;16(6):349-60. doi: 10.1155/2005/385768.

5. Melekos MD and Naber KG. Complicated urinary tract infections. Int J Antimicrob Agents. 2000;15(4):247-56. doi: 10.1016/s0924-8579(00)00168-0.
 

Key points

• The anatomical approach to defining complicated UTIs considers the presence of underlying, predisposing conditions such as structurally or functionally abnormal genitourinary tract or urinary instrumentation or foreign bodies.
• The severity approach to defining complicated UTIs considers the severity of presentation including the presence of systemic manifestations.
• Both approaches should consider populations that are at risk for recurrent or multidrug-resistant infections and infections that can lead to high morbidity.
• Either approach can be used as a guide, but neither should replace clinical suspicion and judgment in determining the depth of treatment.

Additional reading

Choe HS et al. Summary of the UAA‐AAUS guidelines for urinary tract infections. Int J Urol. 2018 Mar;25(3):175-85. doi:10.1111/iju.13493.

Nicolle LE et al. Infectious Diseases Society of America Guidelines for the Diagnosis and Treatment of Asymptomatic Bacteriuria in Adults. Clin Infect Dis. 2005 Mar;40(5):643-54. doi: 10.1086/427507.

Wagenlehner FME et al. Epidemiology, definition and treatment of complicated urinary tract infections. Nat Rev Urol. 2020 Oct;17:586-600. doi:10.1038/s41585-020-0362-4.

Wallace DW et al. Urinalysis: A simple test with complicated interpretation. J Urgent Care Med. 2020 July-Aug;14(10):11-4.

Quiz

A 68-year-old woman with type 2 diabetes mellitus presents to the emergency department with acute fever, chills, dysuria, frequency, and suprapubic pain. She has associated nausea, malaise, and fatigue. She takes metformin and denies recent antibiotic use. Her temperature is 102.8° F, heart rate 118 beats per minute, blood pressure 118/71 mm Hg, and her respiratory rate is 24 breaths per minute. She is ill-appearing and has mild suprapubic tenderness. White blood cell count is 18 k/mcL. Urinalysis is positive for leukocyte esterase, nitrites, and bacteria. Urine microscopy has 120 white blood cells per high power field. What is the most appropriate treatment?

A. Azithromycin

B. Ceftriaxone

C. Cefepime and vancomycin

D. Nitrofurantoin

The answer is B. The patient presents with sepsis secondary to a urinary tract infection. Using the anatomic approach this would be classified as uncomplicated. Using the severity approach, this would be classified as a complicated urinary tract infection. With fever, chills, and signs of sepsis, it’s likely her infection extends beyond the bladder. Given the severity of her presentation, we’d favor treating her as a complicated urinary tract infection with intravenous ceftriaxone. There is no suggestion of resistance or additional MRSA risk factors requiring intravenous vancomycin or cefepime. Nitrofurantoin, although a first-line treatment for uncomplicated cystitis, would not be appropriate if there is suspicion infection extends beyond the bladder. Azithromycin is a first-line option for chlamydia trachomatis, but not a urinary tract infection.




 

Case

A 72-year-old woman with type 2 diabetes mellitus presents with acute dysuria, fever, and flank pain. She had a urinary tract infection (UTI) 3 months prior treated with nitrofurantoin. Temperature is 102° F, heart rate 112 beats per minute, and the remainder of vital signs are normal. She has left costovertebral angle tenderness. Urine microscopy shows 70 WBCs per high power field and bacteria. Is this urinary tract infection complicated?

Background

The urinary tract is divided into the upper tract, which includes the kidneys and ureters, and the lower urinary tract, which includes the bladder, urethra, and prostate. Infection of the lower urinary tract is referred to as cystitis while infection of the upper urinary tract is pyelonephritis. A UTI is the colonization of pathogen(s) within the urinary system that causes an inflammatory response resulting in symptoms and requiring treatment. UTIs occur when there is reduced urine flow, an increase in colonization risk, and when there are factors that facilitate ascent such as catheterization or incontinence.

There are an estimated 150 million cases of UTIs worldwide per year, accounting for $6 billion in health care expenditures.¹ In the inpatient setting, about 40% of nosocomial infections are associated with urinary catheters. This equates to about 1 million catheter-associated UTIs per year in the United States, and up to 40% of hospital gram-negative bacteremia per year are caused by UTIs.¹

UTIs are often classified as either uncomplicated or complicated infections, which can influence the depth of management. UTIs have a wide spectrum of symptoms and can manifest anywhere from mild dysuria treated successfully with outpatient antibiotics to florid sepsis. Uncomplicated simple cystitis is often treated as an outpatient with oral nitrofurantoin or trimethoprim-sulfamethoxazole.² Complicated UTIs are treated with broader antimicrobial coverage, and depending on severity, could require intravenous antibiotics. Many factors affect how a UTI manifests and determining whether an infection is “uncomplicated” or “complicated” is an important first step in guiding management. Unfortunately, there are differing classifications of “complicated” UTIs, making it a complicated issue itself. We outline two common approaches.
 

Anatomic approach

A commonly recognized definition is from the American Urological Association, which states that complicated UTIs are symptomatic cases associated with the presence of “underlying, predisposing conditions and not necessarily clinical severity, invasiveness, or complications.”³ These factors include structural or functional urinary tract abnormalities or urinary instrumentation (see Table 1). These predisposing conditions can increase microbial colonization and decrease therapy efficacy, thus increasing the frequency of infection and relapse.

This population of patients is at high risk of infections with more resistant bacteria such as extended-spectrum beta-lactamase (ESBL) producing Escherichia coli since they often lack the natural genitourinary barriers to infection. In addition, these patients more often undergo multiple antibiotic courses for their frequent infections, which also contributes to their risk of ESBL infections. Genitourinary abnormalities interfere with normal voiding, resulting in impaired flushing of bacteria. For instance, obstruction inhibits complete urinary drainage and increases the persistence of bacteria in biofilms, especially if there are stones or indwelling devices present. Biofilms usually contain a high concentration of organisms including Proteus mirabilis, Morgenella morganii, and Providencia spp.⁴ Keep in mind that, if there is an obstruction, the urinalysis might be without pyuria or bacteriuria.

Instrumentation increases infection risks through the direct introduction of bacteria into the genitourinary tract. Despite the efforts in maintaining sterility in urinary catheter placement, catheters provide a nidus for infection. Catheter-associated UTI (CAUTI) is defined by the Infectious Disease Society of America as UTIs that occur in patients with an indwelling catheter or who had a catheter removed for less than 48 hours who develop urinary symptoms and cultures positive for uropathogenic bacteria.⁴ Studies show that in general, patients with indwelling catheters will develop bacteriuria over time, with 10%-25% eventually developing symptoms.
 

Severity approach

There are other schools of thought that categorize uncomplicated versus complicated UTIs based on the severity of presentation (see Table 2). An uncomplicated UTI would be classified as symptoms and signs of simple cystitis limited to dysuria, frequency, urgency, and suprapubic pain. Using a symptom severity approach, systemic findings such as fever, chills, emesis, flank pain, costovertebral angle tenderness, or other findings of sepsis would be classified as a complicated UTI. These systemic findings would suggest an extension of infection beyond the bladder.

The argument for a symptomatic-based approach of classification is that the severity of symptoms should dictate the degree of management. Not all UTIs in the anatomic approach are severe. In fact, populations that are considered at risk for complicated UTIs by the AUA guidelines in Table 1 often have mild symptomatic cystitis or asymptomatic bacteriuria. Asymptomatic bacteriuria is the colonization of organisms in the urinary tract without active infection. For instance, bacteriuria is present in almost 100% of people with chronic indwelling catheters, 30%-40% of neurogenic bladder requiring intermittent catheterization, and 50% of elderly nursing home residents.⁴ Not all bacteriuria triggers enough of an inflammatory response to cause symptoms that require treatment.
 

Ultimate clinical judgment

Although there are multiple different society recommendations in distinguishing uncomplicated versus complicated UTIs, considering both anatomical and severity risk factors can better aid in clinical decision-making rather than abiding by one classification method alone.

Uncomplicated UTIs from the AUA guidelines can cause severe infections that might require longer courses of broad-spectrum antibiotics. On the other hand, people with anatomic abnormalities can present with mild symptoms that can be treated with a narrow-spectrum antibiotic for a standard time course. Recognizing the severity of the infection and using clinical judgment aids in antibiotic stewardship.

Although the existence of algorithmic approaches can help guide clinical judgment, accounting for the spectrum of host and bacterial factors should ultimately determine the complexity of the disease and management.³ Using clinical suspicion to determine when a UTI should be treated as a complicated infection can ensure effective treatment and decrease the likelihood of sepsis, renal scarring, or end-stage disease.⁵

Back to the case

The case presents an elderly woman with diabetes presenting with sepsis from a UTI. Because of a normal urinary tract and no prior instrumentation, by the AUA definition, she would be classified as an uncomplicated UTI; however, we would classify her as a complicated UTI based on the severity of her presentation. She has a fever, tachycardia, flank pain, and costovertebral angle tenderness that are evidence of infection extending beyond the bladder. She has sepsis warranting inpatient management. Prior urine culture results could aid in determining empiric treatment while waiting for new cultures. In her case, an intravenous antibiotic with broad gram-negative coverage such as ceftriaxone would be appropriate.

Bottom line

There are multiple interpretations of complicated UTIs including both an anatomical and severity approach. Clinical judgment regarding infection severity should determine the depth of management.

Dr. Vu is a hospitalist at the University of Kentucky, Lexington. Dr. Gray is a hospitalist at the University of Kentucky and the Lexington Veterans Affairs Medical Center.

References

1. Folk CS. AUA Core Curriculum: Urinary Tract Infection (Adult). 2021 Mar 1. https://university.auanet.org/core_topic.cfm?coreid=92.

2. Gupta K et al. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: A 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011 Mar 1;52(5):e103-20. doi: 10.1093/cid/ciq257.

3. Johnson JR. Definition of Complicated Urinary Tract Infection. Clin Infect Dis. 2017 February 15;64(4):529. doi: 10.1093/cid/ciw751.

4. Nicolle LE, AMMI Canada Guidelines Committee. Complicated urinary tract infection in adults. Can J Infect Dis Med Microbiol. 2005;16(6):349-60. doi: 10.1155/2005/385768.

5. Melekos MD and Naber KG. Complicated urinary tract infections. Int J Antimicrob Agents. 2000;15(4):247-56. doi: 10.1016/s0924-8579(00)00168-0.
 

Key points

• The anatomical approach to defining complicated UTIs considers the presence of underlying, predisposing conditions such as structurally or functionally abnormal genitourinary tract or urinary instrumentation or foreign bodies.
• The severity approach to defining complicated UTIs considers the severity of presentation including the presence of systemic manifestations.
• Both approaches should consider populations that are at risk for recurrent or multidrug-resistant infections and infections that can lead to high morbidity.
• Either approach can be used as a guide, but neither should replace clinical suspicion and judgment in determining the depth of treatment.

Additional reading

Choe HS et al. Summary of the UAA‐AAUS guidelines for urinary tract infections. Int J Urol. 2018 Mar;25(3):175-85. doi:10.1111/iju.13493.

Nicolle LE et al. Infectious Diseases Society of America Guidelines for the Diagnosis and Treatment of Asymptomatic Bacteriuria in Adults. Clin Infect Dis. 2005 Mar;40(5):643-54. doi: 10.1086/427507.

Wagenlehner FME et al. Epidemiology, definition and treatment of complicated urinary tract infections. Nat Rev Urol. 2020 Oct;17:586-600. doi:10.1038/s41585-020-0362-4.

Wallace DW et al. Urinalysis: A simple test with complicated interpretation. J Urgent Care Med. 2020 July-Aug;14(10):11-4.

Quiz

A 68-year-old woman with type 2 diabetes mellitus presents to the emergency department with acute fever, chills, dysuria, frequency, and suprapubic pain. She has associated nausea, malaise, and fatigue. She takes metformin and denies recent antibiotic use. Her temperature is 102.8° F, heart rate 118 beats per minute, blood pressure 118/71 mm Hg, and her respiratory rate is 24 breaths per minute. She is ill-appearing and has mild suprapubic tenderness. White blood cell count is 18 k/mcL. Urinalysis is positive for leukocyte esterase, nitrites, and bacteria. Urine microscopy has 120 white blood cells per high power field. What is the most appropriate treatment?

A. Azithromycin

B. Ceftriaxone

C. Cefepime and vancomycin

D. Nitrofurantoin

The answer is B. The patient presents with sepsis secondary to a urinary tract infection. Using the anatomic approach this would be classified as uncomplicated. Using the severity approach, this would be classified as a complicated urinary tract infection. With fever, chills, and signs of sepsis, it’s likely her infection extends beyond the bladder. Given the severity of her presentation, we’d favor treating her as a complicated urinary tract infection with intravenous ceftriaxone. There is no suggestion of resistance or additional MRSA risk factors requiring intravenous vancomycin or cefepime. Nitrofurantoin, although a first-line treatment for uncomplicated cystitis, would not be appropriate if there is suspicion infection extends beyond the bladder. Azithromycin is a first-line option for chlamydia trachomatis, but not a urinary tract infection.




 

WESTMINSTER, COLO. – Melissa Blatzer was determined to get her three children caught up on their routine immunizations on a recent Saturday morning at a walk-in clinic in this Denver suburb. It had been about a year since the kids’ last shots, a delay Ms. Blatzer chalked up to the pandemic.

Two-year-old Lincoln Blatzer, in his fleece dinosaur pajamas, waited anxiously in line for his hepatitis A vaccine. His siblings, 14-year-old Nyla Kusumah and 11-year-old Nevan Kusumah, were there for their TDAP, HPV and meningococcal vaccines, plus a COVID-19 shot for Nyla.

“You don’t have to make an appointment and you can take all three at once,” said Ms. Blatzer, who lives several miles away in Commerce City. That convenience outweighed the difficulty of getting everyone up early on a weekend.

Child health experts hope community clinics like this – along with the return to in-person classes, more well-child visits, and the rollout of COVID shots for younger children – can help boost routine childhood immunizations, which dropped during the pandemic. Despite a rebound, immunization rates are still lower than in 2019, and disparities in rates between racial and economic groups, particularly for Black children, have been exacerbated.

“We’re still not back to where we need to be,” said Sean O’Leary, MD, a pediatric infectious disease doctor at Children’s Hospital Colorado and a professor of pediatrics at the University of Colorado at Denver, Aurora.

Routine immunizations protect children against 16 infectious diseases, including measles, diphtheria and chickenpox, and inhibit transmission to the community.

The rollout of COVID shots for younger kids is an opportunity to catch up on routine vaccinations, said Dr. O’Leary, adding that children can receive these vaccines together. Primary care practices, where many children are likely to receive the COVID shots, usually have other childhood vaccines on hand.

“It’s really important that parents and health care providers work together so that all children are up to date on these recommended vaccines,” said Malini DeSilva, MD, an internist and pediatrician at HealthPartners in the Minneapolis–St. Paul area. “Not only for the child’s health but for our community’s health.”

People were reluctant to come out for routine immunizations at the height of the pandemic, said Karen Miller, an immunization nurse manager for the Denver area’s Tri-County Health Department, which ran the Westminster clinic. National and global data confirm what Ms. Miller saw on the ground.

Global vaccine coverage in children fell from 2019 to 2020, according to a recent study by scientists at the Centers for Disease Control and Prevention, the World Health Organization, and UNICEF. Reasons included reduced access, lack of transportation, worries about COVID exposure and supply chain interruptions, the study said.

Third doses of the DTP vaccine and of the polio vaccine decreased from 86% of all eligible children in 2019 to 83% in 2020, according to the study. Worldwide, 22.7 million children had not had their third dose of DTP in 2020, compared with 19 million in 2019. Three doses are far more effective than one or two at protecting children and communities.

In the United States, researchers who studied 2019 and 2020 data on routine vaccinations in California, Colorado, Minnesota, Oregon, Washington, and Wisconsin found substantial disruptions in vaccination rates during the pandemic that continued into September 2020. For example, the percentage of 7-month-old babies who were up to date on vaccinations decreased from 81% in September 2019 to 74% a year later.

The proportion of Black children up to date on immunizations in almost all age groups was lower than that of children in other racial and ethnic groups. This was most pronounced in those turning 18 months old: Only 41% of Black children that age were caught up on vaccinations in September 2020, compared with 57% of all children at 18 months, said Dr. DeSilva, who led that study.

A CDC study of data from the National Immunization Surveys found that race and ethnicity, poverty, and lack of insurance created the greatest disparities in vaccination rates, and the authors noted that extra efforts are needed to counter the pandemic’s disruptions.

In addition to the problems caused by COVID, Ms. Miller said, competing life priorities like work and school impede families from keeping up with shots. Weekend vaccination clinics can help working parents get their children caught up on routine immunizations while they get a flu or COVID shot. Ms. Miller and O’Leary also said reminders via phone, text or email can boost immunizations.

“Vaccines are so effective that I think it’s easy for families to put immunizations on the back burner because we don’t often hear about these diseases,” she said.

It’s a long and nasty list that includes hepatitis A and B, measles, mumps, whooping cough, polio, rubella, rotavirus, pneumococcus, tetanus, diphtheria, human papillomavirus, and meningococcal disease, among others. Even small drops in vaccination coverage can lead to outbreaks. And measles is the perfect example that worries experts, particularly as international travel opens up.

“Measles is among the most contagious diseases known to humankind, meaning that we have to keep very high vaccination coverage to keep it from spreading,” said Dr. O’Leary.

In 2019, 22 measles outbreaks occurred in 17 states in mostly unvaccinated children and adults. Dr. O’Leary said outbreaks in New York City were contained because surrounding areas had high vaccination coverage. But an outbreak in an undervaccinated community still could spread beyond its borders.

In some states a significant number of parents were opposed to routine childhood vaccines even before the pandemic for religious or personal reasons, posing another challenge for health professionals. For example, 87% of Colorado kindergartners were vaccinated against measles, mumps, and rubella during the 2018-19 school year, one of the nation’s lowest rates.

Those rates bumped up to 91% in 2019-20 but are still below the CDC’s target of 95%.

Dr. O’Leary said he does not see the same level of hesitancy for routine immunizations as for COVID. “There has always been vaccine hesitancy and vaccine refusers. But we’ve maintained vaccination rates north of 90% for all routine childhood vaccines for a long time now,” he said.

Dr. DeSilva said the “ripple effects” of missed vaccinations earlier in the pandemic continued into 2021. As children returned to in-person learning this fall, schools may have been the first place families heard about missed vaccinations. Individual states set vaccination requirements, and allowable exemptions, for entry at schools and child care facilities. In 2020, Colorado passed a school entry immunization law that tightened allowable exemptions.

“Schools, where vaccination requirements are generally enforced, are stretched thin for a variety of reasons, including COVID,” said Dr. O’Leary, adding that managing vaccine requirements may be more difficult for some, but not all, schools.

Anayeli Dominguez, 13, was at the Westminster clinic for a Tdap vaccine because her middle school had noticed she was not up to date.

“School nurses play an important role in helping identify students in need of immunizations, and also by connecting families to resources both within the district and in the larger community,” said Denver Public Schools spokesperson Will Jones.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

WESTMINSTER, COLO. – Melissa Blatzer was determined to get her three children caught up on their routine immunizations on a recent Saturday morning at a walk-in clinic in this Denver suburb. It had been about a year since the kids’ last shots, a delay Ms. Blatzer chalked up to the pandemic.

Two-year-old Lincoln Blatzer, in his fleece dinosaur pajamas, waited anxiously in line for his hepatitis A vaccine. His siblings, 14-year-old Nyla Kusumah and 11-year-old Nevan Kusumah, were there for their TDAP, HPV and meningococcal vaccines, plus a COVID-19 shot for Nyla.

“You don’t have to make an appointment and you can take all three at once,” said Ms. Blatzer, who lives several miles away in Commerce City. That convenience outweighed the difficulty of getting everyone up early on a weekend.

Child health experts hope community clinics like this – along with the return to in-person classes, more well-child visits, and the rollout of COVID shots for younger children – can help boost routine childhood immunizations, which dropped during the pandemic. Despite a rebound, immunization rates are still lower than in 2019, and disparities in rates between racial and economic groups, particularly for Black children, have been exacerbated.

“We’re still not back to where we need to be,” said Sean O’Leary, MD, a pediatric infectious disease doctor at Children’s Hospital Colorado and a professor of pediatrics at the University of Colorado at Denver, Aurora.

Routine immunizations protect children against 16 infectious diseases, including measles, diphtheria and chickenpox, and inhibit transmission to the community.

The rollout of COVID shots for younger kids is an opportunity to catch up on routine vaccinations, said Dr. O’Leary, adding that children can receive these vaccines together. Primary care practices, where many children are likely to receive the COVID shots, usually have other childhood vaccines on hand.

“It’s really important that parents and health care providers work together so that all children are up to date on these recommended vaccines,” said Malini DeSilva, MD, an internist and pediatrician at HealthPartners in the Minneapolis–St. Paul area. “Not only for the child’s health but for our community’s health.”

People were reluctant to come out for routine immunizations at the height of the pandemic, said Karen Miller, an immunization nurse manager for the Denver area’s Tri-County Health Department, which ran the Westminster clinic. National and global data confirm what Ms. Miller saw on the ground.

Global vaccine coverage in children fell from 2019 to 2020, according to a recent study by scientists at the Centers for Disease Control and Prevention, the World Health Organization, and UNICEF. Reasons included reduced access, lack of transportation, worries about COVID exposure and supply chain interruptions, the study said.

Third doses of the DTP vaccine and of the polio vaccine decreased from 86% of all eligible children in 2019 to 83% in 2020, according to the study. Worldwide, 22.7 million children had not had their third dose of DTP in 2020, compared with 19 million in 2019. Three doses are far more effective than one or two at protecting children and communities.

In the United States, researchers who studied 2019 and 2020 data on routine vaccinations in California, Colorado, Minnesota, Oregon, Washington, and Wisconsin found substantial disruptions in vaccination rates during the pandemic that continued into September 2020. For example, the percentage of 7-month-old babies who were up to date on vaccinations decreased from 81% in September 2019 to 74% a year later.

The proportion of Black children up to date on immunizations in almost all age groups was lower than that of children in other racial and ethnic groups. This was most pronounced in those turning 18 months old: Only 41% of Black children that age were caught up on vaccinations in September 2020, compared with 57% of all children at 18 months, said Dr. DeSilva, who led that study.

A CDC study of data from the National Immunization Surveys found that race and ethnicity, poverty, and lack of insurance created the greatest disparities in vaccination rates, and the authors noted that extra efforts are needed to counter the pandemic’s disruptions.

In addition to the problems caused by COVID, Ms. Miller said, competing life priorities like work and school impede families from keeping up with shots. Weekend vaccination clinics can help working parents get their children caught up on routine immunizations while they get a flu or COVID shot. Ms. Miller and O’Leary also said reminders via phone, text or email can boost immunizations.

“Vaccines are so effective that I think it’s easy for families to put immunizations on the back burner because we don’t often hear about these diseases,” she said.

It’s a long and nasty list that includes hepatitis A and B, measles, mumps, whooping cough, polio, rubella, rotavirus, pneumococcus, tetanus, diphtheria, human papillomavirus, and meningococcal disease, among others. Even small drops in vaccination coverage can lead to outbreaks. And measles is the perfect example that worries experts, particularly as international travel opens up.

“Measles is among the most contagious diseases known to humankind, meaning that we have to keep very high vaccination coverage to keep it from spreading,” said Dr. O’Leary.

In 2019, 22 measles outbreaks occurred in 17 states in mostly unvaccinated children and adults. Dr. O’Leary said outbreaks in New York City were contained because surrounding areas had high vaccination coverage. But an outbreak in an undervaccinated community still could spread beyond its borders.

In some states a significant number of parents were opposed to routine childhood vaccines even before the pandemic for religious or personal reasons, posing another challenge for health professionals. For example, 87% of Colorado kindergartners were vaccinated against measles, mumps, and rubella during the 2018-19 school year, one of the nation’s lowest rates.

Those rates bumped up to 91% in 2019-20 but are still below the CDC’s target of 95%.

Dr. O’Leary said he does not see the same level of hesitancy for routine immunizations as for COVID. “There has always been vaccine hesitancy and vaccine refusers. But we’ve maintained vaccination rates north of 90% for all routine childhood vaccines for a long time now,” he said.

Dr. DeSilva said the “ripple effects” of missed vaccinations earlier in the pandemic continued into 2021. As children returned to in-person learning this fall, schools may have been the first place families heard about missed vaccinations. Individual states set vaccination requirements, and allowable exemptions, for entry at schools and child care facilities. In 2020, Colorado passed a school entry immunization law that tightened allowable exemptions.

“Schools, where vaccination requirements are generally enforced, are stretched thin for a variety of reasons, including COVID,” said Dr. O’Leary, adding that managing vaccine requirements may be more difficult for some, but not all, schools.

Anayeli Dominguez, 13, was at the Westminster clinic for a Tdap vaccine because her middle school had noticed she was not up to date.

“School nurses play an important role in helping identify students in need of immunizations, and also by connecting families to resources both within the district and in the larger community,” said Denver Public Schools spokesperson Will Jones.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

WESTMINSTER, COLO. – Melissa Blatzer was determined to get her three children caught up on their routine immunizations on a recent Saturday morning at a walk-in clinic in this Denver suburb. It had been about a year since the kids’ last shots, a delay Ms. Blatzer chalked up to the pandemic.

Two-year-old Lincoln Blatzer, in his fleece dinosaur pajamas, waited anxiously in line for his hepatitis A vaccine. His siblings, 14-year-old Nyla Kusumah and 11-year-old Nevan Kusumah, were there for their TDAP, HPV and meningococcal vaccines, plus a COVID-19 shot for Nyla.

“You don’t have to make an appointment and you can take all three at once,” said Ms. Blatzer, who lives several miles away in Commerce City. That convenience outweighed the difficulty of getting everyone up early on a weekend.

Child health experts hope community clinics like this – along with the return to in-person classes, more well-child visits, and the rollout of COVID shots for younger children – can help boost routine childhood immunizations, which dropped during the pandemic. Despite a rebound, immunization rates are still lower than in 2019, and disparities in rates between racial and economic groups, particularly for Black children, have been exacerbated.

“We’re still not back to where we need to be,” said Sean O’Leary, MD, a pediatric infectious disease doctor at Children’s Hospital Colorado and a professor of pediatrics at the University of Colorado at Denver, Aurora.

Routine immunizations protect children against 16 infectious diseases, including measles, diphtheria and chickenpox, and inhibit transmission to the community.

The rollout of COVID shots for younger kids is an opportunity to catch up on routine vaccinations, said Dr. O’Leary, adding that children can receive these vaccines together. Primary care practices, where many children are likely to receive the COVID shots, usually have other childhood vaccines on hand.

“It’s really important that parents and health care providers work together so that all children are up to date on these recommended vaccines,” said Malini DeSilva, MD, an internist and pediatrician at HealthPartners in the Minneapolis–St. Paul area. “Not only for the child’s health but for our community’s health.”

People were reluctant to come out for routine immunizations at the height of the pandemic, said Karen Miller, an immunization nurse manager for the Denver area’s Tri-County Health Department, which ran the Westminster clinic. National and global data confirm what Ms. Miller saw on the ground.

Global vaccine coverage in children fell from 2019 to 2020, according to a recent study by scientists at the Centers for Disease Control and Prevention, the World Health Organization, and UNICEF. Reasons included reduced access, lack of transportation, worries about COVID exposure and supply chain interruptions, the study said.

Third doses of the DTP vaccine and of the polio vaccine decreased from 86% of all eligible children in 2019 to 83% in 2020, according to the study. Worldwide, 22.7 million children had not had their third dose of DTP in 2020, compared with 19 million in 2019. Three doses are far more effective than one or two at protecting children and communities.

In the United States, researchers who studied 2019 and 2020 data on routine vaccinations in California, Colorado, Minnesota, Oregon, Washington, and Wisconsin found substantial disruptions in vaccination rates during the pandemic that continued into September 2020. For example, the percentage of 7-month-old babies who were up to date on vaccinations decreased from 81% in September 2019 to 74% a year later.

The proportion of Black children up to date on immunizations in almost all age groups was lower than that of children in other racial and ethnic groups. This was most pronounced in those turning 18 months old: Only 41% of Black children that age were caught up on vaccinations in September 2020, compared with 57% of all children at 18 months, said Dr. DeSilva, who led that study.

A CDC study of data from the National Immunization Surveys found that race and ethnicity, poverty, and lack of insurance created the greatest disparities in vaccination rates, and the authors noted that extra efforts are needed to counter the pandemic’s disruptions.

In addition to the problems caused by COVID, Ms. Miller said, competing life priorities like work and school impede families from keeping up with shots. Weekend vaccination clinics can help working parents get their children caught up on routine immunizations while they get a flu or COVID shot. Ms. Miller and O’Leary also said reminders via phone, text or email can boost immunizations.

“Vaccines are so effective that I think it’s easy for families to put immunizations on the back burner because we don’t often hear about these diseases,” she said.

It’s a long and nasty list that includes hepatitis A and B, measles, mumps, whooping cough, polio, rubella, rotavirus, pneumococcus, tetanus, diphtheria, human papillomavirus, and meningococcal disease, among others. Even small drops in vaccination coverage can lead to outbreaks. And measles is the perfect example that worries experts, particularly as international travel opens up.

“Measles is among the most contagious diseases known to humankind, meaning that we have to keep very high vaccination coverage to keep it from spreading,” said Dr. O’Leary.

In 2019, 22 measles outbreaks occurred in 17 states in mostly unvaccinated children and adults. Dr. O’Leary said outbreaks in New York City were contained because surrounding areas had high vaccination coverage. But an outbreak in an undervaccinated community still could spread beyond its borders.

In some states a significant number of parents were opposed to routine childhood vaccines even before the pandemic for religious or personal reasons, posing another challenge for health professionals. For example, 87% of Colorado kindergartners were vaccinated against measles, mumps, and rubella during the 2018-19 school year, one of the nation’s lowest rates.

Those rates bumped up to 91% in 2019-20 but are still below the CDC’s target of 95%.

Dr. O’Leary said he does not see the same level of hesitancy for routine immunizations as for COVID. “There has always been vaccine hesitancy and vaccine refusers. But we’ve maintained vaccination rates north of 90% for all routine childhood vaccines for a long time now,” he said.

Dr. DeSilva said the “ripple effects” of missed vaccinations earlier in the pandemic continued into 2021. As children returned to in-person learning this fall, schools may have been the first place families heard about missed vaccinations. Individual states set vaccination requirements, and allowable exemptions, for entry at schools and child care facilities. In 2020, Colorado passed a school entry immunization law that tightened allowable exemptions.

“Schools, where vaccination requirements are generally enforced, are stretched thin for a variety of reasons, including COVID,” said Dr. O’Leary, adding that managing vaccine requirements may be more difficult for some, but not all, schools.

Anayeli Dominguez, 13, was at the Westminster clinic for a Tdap vaccine because her middle school had noticed she was not up to date.

“School nurses play an important role in helping identify students in need of immunizations, and also by connecting families to resources both within the district and in the larger community,” said Denver Public Schools spokesperson Will Jones.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The Diagnosis: Vibrio vulnificus Infection

At the initial presentation, the differential diagnosis included infectious processes such as bacterial or angioinvasive fungal infections or an inflammatory process such as pyoderma gangrenosum. Blood cultures were found to be positive for pansensitive Vibrio vulnificus. He initially was treated with piperacillin-tazobactam and received surgical debridement of the affected tissues. Pathologic interpretation of the wound tissues revealed a diagnosis of necrotizing softtissue infection and positive Candida albicans growth. He received topical bacitracin on discharge as well as a 7-day course of amoxicillin-clavulanate and fluconazole. He continued to receive debridement procedures and skin grafts, followed by topical mupirocin treatment and silver sulfadiazine. He was seen 6 weeks after discharge with healing wounds and healthy-appearing granulation tissue at the base.

Our patient’s presentation of retiform purpura with stellate necrosis was consistent with a wide range of serious pathologies ranging from medium-vessel vasculitis to thromboembolic phenomena and angioinvasive fungal infections.¹ Although Vibrio infection rarely is the first explanation that comes to mind when observing necrotic retiform purpura, the chronic nonhealing injury on the leg combined with the recent history of ocean swimming made V vulnificus stand out as a likely culprit. Although V vulnificus infection traditionally presents with cellulitis, edema, and hemorrhagic bulla,² necrosis also has been observed.³Vibrio vulnificus produces multiple virulence factors, and it is believed that these severe cutaneous symptoms are attributable to the production of a specific metalloprotease that enhances vascular permeability, thereby inducing hemorrhage within the vascular basement membrane zone.²

Vibrio vulnificus is an opportunistic bacterial pathogen associated with consumption of contaminated seafood or swimming in ocean waters with open wounds. Infections are rare, with only approximately 100 cases reported annually in the United States.4 However, V vulnificus infections have demonstrated increasing incidence in recent years, especially infections of pre-existing wounds.^4,5 Risk factors for their development include age over 40 years and underlying conditions including liver disease, diabetes mellitus, and immune dysfunction.⁴Vibrio vulnificus infections also demonstrate a strong male predilection, with almost 90% of infections occurring in males.⁴ Although the precise etiology of this sex discrepancy remains unknown, estrogen has been suggested to be a protective factor.⁶ Alternatively, behavioral differences also have been proposed as possible explanations for this discrepancy, with women less likely to consume seafood or go swimming. However, epidemiologic data reveal strong correlations between male sex and liver cirrhosis, a primary risk factor for V vulnificus infections, suggesting that male sex may simply be a confounding variable.⁷

Infections with V vulnificus are notable for their short incubation periods, with onset of symptoms occurring within 24 hours of exposure, making prompt diagnosis and treatment of high importance.⁸ Although rare, V vulnificus infections are associated with high mortality rates. From 1988 to 2010, nearly 600 deaths were reported secondary to V vulnificus infections.⁴ Wound infections carry a 17.6% fatality rate,⁴ while bloodborne V vulnificus infections exceed 50% fatality.⁸ Although sepsis secondary to V vulnificus usually is caused by ingestion of raw or undercooked shellfish, primarily oysters,⁴ our case highlights a rarer instance of both sepsis and localized infection stemming from ocean water exposure.

Vibrio vulnificus is an obligate halophile and therefore is found in marine environments rather than freshwater bodies. However, it rarely is isolated from bodies of water with salinities over 25 parts per thousand, such as the Mediterranean Sea; it usually is found in warmer waters, making it more common in the summer months from May to October.⁴ Given this proclivity for warmer environments, climate change has contributed to both a greater incidence and global distribution of V vulnificus. ^9,10

Treatment of V vulnificus infections centers on antibiotic treatment, with Vibrio species generally demonstrating susceptibility to most antibiotics of human significance.¹¹ However, some Vibrio isolates within the United States have demonstrated antibiotic resistance; 45% of a variety of clinical and environmental samples from South Carolina and Georgia demonstrated resistance to at least 3 antibiotic classes, and 17.3% resisted 8 or more classes of antibiotics.¹² These included medications such as doxycycline, tetracycline, aminoglycosides, and cephalosporins—agents that normally are prescribed for V vulnificus infections. Although tetracyclines have long been touted as the preferred treatment of V vulnificus infections, the spread of antibiotic resistance may require greater reliance on alternative regimens such as combinations of cephalosporins and doxycycline or a single fluoroquinolone.¹³ Although rare, Vibrio infections can have rapidly fatal consequences and should be given serious consideration when evaluating patients with relevant risk factors.

The differential diagnosis included angioinvasive mucormycosis, calciphylaxis, pyoderma gangrenosum, and Stevens-Johnson syndrome/toxic epidermal necrolysis. Mucormycosis is a fungal infection caused by Mucorales fungi that most commonly is seen in patients with diabetes mellitus, hematologic malignancies, neutropenia, and immunocompromise.¹⁴ Calciphylaxis is a condition involving microvascular occlusion due to diffuse calcium deposition in cutaneous blood vessels. It typically presents as violaceous retiform patches and plaques commonly seen on areas such as the thighs, buttocks, or abdomen and usually is associated with chronic renal failure, hemodialysis, and/or secondary hyperparathyroidism.¹⁵ Pyoderma gangrenosum is an inflammatory condition involving neutrophilic ulceration of the skin that typically presents as ulceration with a classically undermined border. It frequently is considered a diagnosis of exclusion and therefore requires that providers rule out other causes of ulceration prior to diagnosis.¹⁶ Stevens-Johnson syndrome/toxic epidermal necrolysis is a rare drug reaction involving mucosal erosions and cutaneous detachment.¹⁷ This diagnosis is less likely given that our patient lacked mucosal involvement and did not have any notable medication exposures prior to symptom onset.

The Diagnosis: Vibrio vulnificus Infection

At the initial presentation, the differential diagnosis included infectious processes such as bacterial or angioinvasive fungal infections or an inflammatory process such as pyoderma gangrenosum. Blood cultures were found to be positive for pansensitive Vibrio vulnificus. He initially was treated with piperacillin-tazobactam and received surgical debridement of the affected tissues. Pathologic interpretation of the wound tissues revealed a diagnosis of necrotizing softtissue infection and positive Candida albicans growth. He received topical bacitracin on discharge as well as a 7-day course of amoxicillin-clavulanate and fluconazole. He continued to receive debridement procedures and skin grafts, followed by topical mupirocin treatment and silver sulfadiazine. He was seen 6 weeks after discharge with healing wounds and healthy-appearing granulation tissue at the base.

Our patient’s presentation of retiform purpura with stellate necrosis was consistent with a wide range of serious pathologies ranging from medium-vessel vasculitis to thromboembolic phenomena and angioinvasive fungal infections.¹ Although Vibrio infection rarely is the first explanation that comes to mind when observing necrotic retiform purpura, the chronic nonhealing injury on the leg combined with the recent history of ocean swimming made V vulnificus stand out as a likely culprit. Although V vulnificus infection traditionally presents with cellulitis, edema, and hemorrhagic bulla,² necrosis also has been observed.³Vibrio vulnificus produces multiple virulence factors, and it is believed that these severe cutaneous symptoms are attributable to the production of a specific metalloprotease that enhances vascular permeability, thereby inducing hemorrhage within the vascular basement membrane zone.²

Vibrio vulnificus is an opportunistic bacterial pathogen associated with consumption of contaminated seafood or swimming in ocean waters with open wounds. Infections are rare, with only approximately 100 cases reported annually in the United States.4 However, V vulnificus infections have demonstrated increasing incidence in recent years, especially infections of pre-existing wounds.^4,5 Risk factors for their development include age over 40 years and underlying conditions including liver disease, diabetes mellitus, and immune dysfunction.⁴Vibrio vulnificus infections also demonstrate a strong male predilection, with almost 90% of infections occurring in males.⁴ Although the precise etiology of this sex discrepancy remains unknown, estrogen has been suggested to be a protective factor.⁶ Alternatively, behavioral differences also have been proposed as possible explanations for this discrepancy, with women less likely to consume seafood or go swimming. However, epidemiologic data reveal strong correlations between male sex and liver cirrhosis, a primary risk factor for V vulnificus infections, suggesting that male sex may simply be a confounding variable.⁷

Infections with V vulnificus are notable for their short incubation periods, with onset of symptoms occurring within 24 hours of exposure, making prompt diagnosis and treatment of high importance.⁸ Although rare, V vulnificus infections are associated with high mortality rates. From 1988 to 2010, nearly 600 deaths were reported secondary to V vulnificus infections.⁴ Wound infections carry a 17.6% fatality rate,⁴ while bloodborne V vulnificus infections exceed 50% fatality.⁸ Although sepsis secondary to V vulnificus usually is caused by ingestion of raw or undercooked shellfish, primarily oysters,⁴ our case highlights a rarer instance of both sepsis and localized infection stemming from ocean water exposure.

Vibrio vulnificus is an obligate halophile and therefore is found in marine environments rather than freshwater bodies. However, it rarely is isolated from bodies of water with salinities over 25 parts per thousand, such as the Mediterranean Sea; it usually is found in warmer waters, making it more common in the summer months from May to October.⁴ Given this proclivity for warmer environments, climate change has contributed to both a greater incidence and global distribution of V vulnificus. ^9,10

Treatment of V vulnificus infections centers on antibiotic treatment, with Vibrio species generally demonstrating susceptibility to most antibiotics of human significance.¹¹ However, some Vibrio isolates within the United States have demonstrated antibiotic resistance; 45% of a variety of clinical and environmental samples from South Carolina and Georgia demonstrated resistance to at least 3 antibiotic classes, and 17.3% resisted 8 or more classes of antibiotics.¹² These included medications such as doxycycline, tetracycline, aminoglycosides, and cephalosporins—agents that normally are prescribed for V vulnificus infections. Although tetracyclines have long been touted as the preferred treatment of V vulnificus infections, the spread of antibiotic resistance may require greater reliance on alternative regimens such as combinations of cephalosporins and doxycycline or a single fluoroquinolone.¹³ Although rare, Vibrio infections can have rapidly fatal consequences and should be given serious consideration when evaluating patients with relevant risk factors.

The differential diagnosis included angioinvasive mucormycosis, calciphylaxis, pyoderma gangrenosum, and Stevens-Johnson syndrome/toxic epidermal necrolysis. Mucormycosis is a fungal infection caused by Mucorales fungi that most commonly is seen in patients with diabetes mellitus, hematologic malignancies, neutropenia, and immunocompromise.¹⁴ Calciphylaxis is a condition involving microvascular occlusion due to diffuse calcium deposition in cutaneous blood vessels. It typically presents as violaceous retiform patches and plaques commonly seen on areas such as the thighs, buttocks, or abdomen and usually is associated with chronic renal failure, hemodialysis, and/or secondary hyperparathyroidism.¹⁵ Pyoderma gangrenosum is an inflammatory condition involving neutrophilic ulceration of the skin that typically presents as ulceration with a classically undermined border. It frequently is considered a diagnosis of exclusion and therefore requires that providers rule out other causes of ulceration prior to diagnosis.¹⁶ Stevens-Johnson syndrome/toxic epidermal necrolysis is a rare drug reaction involving mucosal erosions and cutaneous detachment.¹⁷ This diagnosis is less likely given that our patient lacked mucosal involvement and did not have any notable medication exposures prior to symptom onset.

The Diagnosis: Vibrio vulnificus Infection

At the initial presentation, the differential diagnosis included infectious processes such as bacterial or angioinvasive fungal infections or an inflammatory process such as pyoderma gangrenosum. Blood cultures were found to be positive for pansensitive Vibrio vulnificus. He initially was treated with piperacillin-tazobactam and received surgical debridement of the affected tissues. Pathologic interpretation of the wound tissues revealed a diagnosis of necrotizing softtissue infection and positive Candida albicans growth. He received topical bacitracin on discharge as well as a 7-day course of amoxicillin-clavulanate and fluconazole. He continued to receive debridement procedures and skin grafts, followed by topical mupirocin treatment and silver sulfadiazine. He was seen 6 weeks after discharge with healing wounds and healthy-appearing granulation tissue at the base.

Our patient’s presentation of retiform purpura with stellate necrosis was consistent with a wide range of serious pathologies ranging from medium-vessel vasculitis to thromboembolic phenomena and angioinvasive fungal infections.¹ Although Vibrio infection rarely is the first explanation that comes to mind when observing necrotic retiform purpura, the chronic nonhealing injury on the leg combined with the recent history of ocean swimming made V vulnificus stand out as a likely culprit. Although V vulnificus infection traditionally presents with cellulitis, edema, and hemorrhagic bulla,² necrosis also has been observed.³Vibrio vulnificus produces multiple virulence factors, and it is believed that these severe cutaneous symptoms are attributable to the production of a specific metalloprotease that enhances vascular permeability, thereby inducing hemorrhage within the vascular basement membrane zone.²

Vibrio vulnificus is an opportunistic bacterial pathogen associated with consumption of contaminated seafood or swimming in ocean waters with open wounds. Infections are rare, with only approximately 100 cases reported annually in the United States.4 However, V vulnificus infections have demonstrated increasing incidence in recent years, especially infections of pre-existing wounds.^4,5 Risk factors for their development include age over 40 years and underlying conditions including liver disease, diabetes mellitus, and immune dysfunction.⁴Vibrio vulnificus infections also demonstrate a strong male predilection, with almost 90% of infections occurring in males.⁴ Although the precise etiology of this sex discrepancy remains unknown, estrogen has been suggested to be a protective factor.⁶ Alternatively, behavioral differences also have been proposed as possible explanations for this discrepancy, with women less likely to consume seafood or go swimming. However, epidemiologic data reveal strong correlations between male sex and liver cirrhosis, a primary risk factor for V vulnificus infections, suggesting that male sex may simply be a confounding variable.⁷

Infections with V vulnificus are notable for their short incubation periods, with onset of symptoms occurring within 24 hours of exposure, making prompt diagnosis and treatment of high importance.⁸ Although rare, V vulnificus infections are associated with high mortality rates. From 1988 to 2010, nearly 600 deaths were reported secondary to V vulnificus infections.⁴ Wound infections carry a 17.6% fatality rate,⁴ while bloodborne V vulnificus infections exceed 50% fatality.⁸ Although sepsis secondary to V vulnificus usually is caused by ingestion of raw or undercooked shellfish, primarily oysters,⁴ our case highlights a rarer instance of both sepsis and localized infection stemming from ocean water exposure.

Vibrio vulnificus is an obligate halophile and therefore is found in marine environments rather than freshwater bodies. However, it rarely is isolated from bodies of water with salinities over 25 parts per thousand, such as the Mediterranean Sea; it usually is found in warmer waters, making it more common in the summer months from May to October.⁴ Given this proclivity for warmer environments, climate change has contributed to both a greater incidence and global distribution of V vulnificus. ^9,10

Treatment of V vulnificus infections centers on antibiotic treatment, with Vibrio species generally demonstrating susceptibility to most antibiotics of human significance.¹¹ However, some Vibrio isolates within the United States have demonstrated antibiotic resistance; 45% of a variety of clinical and environmental samples from South Carolina and Georgia demonstrated resistance to at least 3 antibiotic classes, and 17.3% resisted 8 or more classes of antibiotics.¹² These included medications such as doxycycline, tetracycline, aminoglycosides, and cephalosporins—agents that normally are prescribed for V vulnificus infections. Although tetracyclines have long been touted as the preferred treatment of V vulnificus infections, the spread of antibiotic resistance may require greater reliance on alternative regimens such as combinations of cephalosporins and doxycycline or a single fluoroquinolone.¹³ Although rare, Vibrio infections can have rapidly fatal consequences and should be given serious consideration when evaluating patients with relevant risk factors.

The differential diagnosis included angioinvasive mucormycosis, calciphylaxis, pyoderma gangrenosum, and Stevens-Johnson syndrome/toxic epidermal necrolysis. Mucormycosis is a fungal infection caused by Mucorales fungi that most commonly is seen in patients with diabetes mellitus, hematologic malignancies, neutropenia, and immunocompromise.¹⁴ Calciphylaxis is a condition involving microvascular occlusion due to diffuse calcium deposition in cutaneous blood vessels. It typically presents as violaceous retiform patches and plaques commonly seen on areas such as the thighs, buttocks, or abdomen and usually is associated with chronic renal failure, hemodialysis, and/or secondary hyperparathyroidism.¹⁵ Pyoderma gangrenosum is an inflammatory condition involving neutrophilic ulceration of the skin that typically presents as ulceration with a classically undermined border. It frequently is considered a diagnosis of exclusion and therefore requires that providers rule out other causes of ulceration prior to diagnosis.¹⁶ Stevens-Johnson syndrome/toxic epidermal necrolysis is a rare drug reaction involving mucosal erosions and cutaneous detachment.¹⁷ This diagnosis is less likely given that our patient lacked mucosal involvement and did not have any notable medication exposures prior to symptom onset.

Over the past 2 years, the COVID-19 pandemic has caused numerous disruptions in health care, including in global HIV/AIDS services. But new data presented at the Association of Nurses in AIDS Care (ANAC) 2021 Annual Meeting suggest that practitioners quickly adapted to challenges posed by the pandemic, and care and prevention services around the world have begun to return to prepandemic levels.

These rebounding numbers “show how resilient the HIV system can be,” Jennifer Kates, PhD, senior vice president and director of global health and HIV policy at the Kaiser Family Foundation (KFF), said in an interview. She presented the data during her ANAC plenary talk on Nov. 11. Dr. Kates noted that continued recovery relies on improving global access to and delivery of COVID-19 vaccines. “If we do not have control of COVID, we are going to see endless cycles of impact,” she said during her talk.
 

COVID-19 and HIV services

Although there was concern that the pandemic could disrupt access to antiretrovirals, the Global Fund previously reported a nearly 9% increase in people receiving antiretroviral therapy (ART) from 2019 to 2020. HIV prevention and testing did take a hit: There was a 22% decrease in testing for HIV and an 11% decline in the number of people receiving HIV prevention services over that period.

New data from the President’s Emergency Plan for AIDS Relief (PEPFAR) showed similar trends. Consistent with the Global Fund’s findings, a KFF analysis of PEPFAR data found that the number of people receiving ART grew in 2020, climbing from 16.0 million in the first quarter (Q1) of 2020 to 17.4 million by the end of the year. The most recent data from PEPFAR suggest that the number had climbed to 18.4 million by September 2021.

However, there was a 24% decrease in the number of newly enrolled individuals receiving ART from Q2 to Q3 in 2020. It dipped from 669,436 to 509,509. There was a similar decrease in the number of people being tested for HIV, dropping 25% from an estimated 16,700 to 12,500 from Q2 to Q3. But by the end of the year, both measurements had rebounded: New enrollments in ART grew 31%, and HIV testing grew nearly 41% compared to Q3.

The DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe) program, which is focused on adolescent girls and young women, saw a dip in preexposure prophylaxis (PrEP) and other preventive services in Q4 2020, but numbers surpassed prepandemic levels by June 2021.

PEPFAR helped speed recovery, Dr. Kates said, by providing guidance on COVID-19 protocols to the field and implementing innovations, such as accelerated 3- and 6-month medication dispensing, virtual platforms, and decentralized drug delivery. In addition, the U.S. Congress allocated $3.8 billion in emergency funding in fiscal year 2021 to help mitigate the effects of COVID-19 on HIV and AIDS care.
 

Longer-term outcomes still unclear

Although these numbers are encouraging, some of the effects of COVID-19 on the HIV epidemic are still unknown – in particular, whether these documented dips in preventive services will translate to an increase in new infections. This will not be clear until a year or 2 from now, Dr. Kates noted. Increased use of ART as well as an increase in some behaviors associated with the pandemic, such as decreased social contact, are factors that mitigate an increase in the rate of infections, she said, but “how that all is going to play out we don’t know for sure.”

Other conference attendees expressed anxiety about the possibility of an increase in the rate of infections. “I’m waiting for the other shoe to drop, as it were,” Barb Cardell, training and technical assistance director at Positive Women’s Network–USA, in Oakland, Calif., said in an interview. The Positive Women’s Network is a national organization of women living with HIV. “Starting late in 2019, we have been cautioning public health officials in states and federally that there will likely be an uptick in HIV diagnosis as we return to whatever ‘normal’ looks like these days,” Ms. Cardell noted, adding, “We have all heard stories of folks that had an exposure and weren’t able to access PrEP during the pandemic and hence seroconverted.”

Kara McGee, associate clinical professor at Duke University School of Nursing, Durham, N.C., shared similar sentiments. “Many people at risk of acquiring HIV had trouble accessing testing and prevention prior to the pandemic, and service interruptions due to the COVID-19 pandemic have only worsened access – especially in rural areas,” she told this news organization.

Need for equitable vaccine access

For HIV services to continue to rebound, COVID-19 vaccination needs to be made a priority globally, Dr. Kates said. But data suggest lower-income countries are being left behind. In high-income countries, 65% of the population has been fully vaccinated, compared to 2% of people in the lowest-income countries. A KFF analysis projected that at the current rates of vaccination, these disparities will widen over time. COVID-19 testing rates in lower-income countries also lag. In high-income countries, 740 tests per 100,000 individuals are conducted daily; in low-income countries, that rate is 13 daily tests per 100,000 people. Until we can achieve more equitable access globally, the documented recovery of HIV is “precarious,” Dr. Kates said.

Ms. McGee agreed with Dr. Kates and was surprised by the extent of global inequities in the COVID-19 response. She said these issues should be a focus for the HIV health care community moving forward. “I think there are lot of us who have worked in the HIV field for many years – both domestically and internationally – who did not fully grasp the global disparities and need to consider how we can advocate for more equal access and distribution,” she said.

A version of this article first appeared on Medscape.com.

Over the past 2 years, the COVID-19 pandemic has caused numerous disruptions in health care, including in global HIV/AIDS services. But new data presented at the Association of Nurses in AIDS Care (ANAC) 2021 Annual Meeting suggest that practitioners quickly adapted to challenges posed by the pandemic, and care and prevention services around the world have begun to return to prepandemic levels.

These rebounding numbers “show how resilient the HIV system can be,” Jennifer Kates, PhD, senior vice president and director of global health and HIV policy at the Kaiser Family Foundation (KFF), said in an interview. She presented the data during her ANAC plenary talk on Nov. 11. Dr. Kates noted that continued recovery relies on improving global access to and delivery of COVID-19 vaccines. “If we do not have control of COVID, we are going to see endless cycles of impact,” she said during her talk.
 

COVID-19 and HIV services

Although there was concern that the pandemic could disrupt access to antiretrovirals, the Global Fund previously reported a nearly 9% increase in people receiving antiretroviral therapy (ART) from 2019 to 2020. HIV prevention and testing did take a hit: There was a 22% decrease in testing for HIV and an 11% decline in the number of people receiving HIV prevention services over that period.

New data from the President’s Emergency Plan for AIDS Relief (PEPFAR) showed similar trends. Consistent with the Global Fund’s findings, a KFF analysis of PEPFAR data found that the number of people receiving ART grew in 2020, climbing from 16.0 million in the first quarter (Q1) of 2020 to 17.4 million by the end of the year. The most recent data from PEPFAR suggest that the number had climbed to 18.4 million by September 2021.

However, there was a 24% decrease in the number of newly enrolled individuals receiving ART from Q2 to Q3 in 2020. It dipped from 669,436 to 509,509. There was a similar decrease in the number of people being tested for HIV, dropping 25% from an estimated 16,700 to 12,500 from Q2 to Q3. But by the end of the year, both measurements had rebounded: New enrollments in ART grew 31%, and HIV testing grew nearly 41% compared to Q3.

The DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe) program, which is focused on adolescent girls and young women, saw a dip in preexposure prophylaxis (PrEP) and other preventive services in Q4 2020, but numbers surpassed prepandemic levels by June 2021.

PEPFAR helped speed recovery, Dr. Kates said, by providing guidance on COVID-19 protocols to the field and implementing innovations, such as accelerated 3- and 6-month medication dispensing, virtual platforms, and decentralized drug delivery. In addition, the U.S. Congress allocated $3.8 billion in emergency funding in fiscal year 2021 to help mitigate the effects of COVID-19 on HIV and AIDS care.
 

Longer-term outcomes still unclear

Although these numbers are encouraging, some of the effects of COVID-19 on the HIV epidemic are still unknown – in particular, whether these documented dips in preventive services will translate to an increase in new infections. This will not be clear until a year or 2 from now, Dr. Kates noted. Increased use of ART as well as an increase in some behaviors associated with the pandemic, such as decreased social contact, are factors that mitigate an increase in the rate of infections, she said, but “how that all is going to play out we don’t know for sure.”

Other conference attendees expressed anxiety about the possibility of an increase in the rate of infections. “I’m waiting for the other shoe to drop, as it were,” Barb Cardell, training and technical assistance director at Positive Women’s Network–USA, in Oakland, Calif., said in an interview. The Positive Women’s Network is a national organization of women living with HIV. “Starting late in 2019, we have been cautioning public health officials in states and federally that there will likely be an uptick in HIV diagnosis as we return to whatever ‘normal’ looks like these days,” Ms. Cardell noted, adding, “We have all heard stories of folks that had an exposure and weren’t able to access PrEP during the pandemic and hence seroconverted.”

Kara McGee, associate clinical professor at Duke University School of Nursing, Durham, N.C., shared similar sentiments. “Many people at risk of acquiring HIV had trouble accessing testing and prevention prior to the pandemic, and service interruptions due to the COVID-19 pandemic have only worsened access – especially in rural areas,” she told this news organization.

Need for equitable vaccine access

For HIV services to continue to rebound, COVID-19 vaccination needs to be made a priority globally, Dr. Kates said. But data suggest lower-income countries are being left behind. In high-income countries, 65% of the population has been fully vaccinated, compared to 2% of people in the lowest-income countries. A KFF analysis projected that at the current rates of vaccination, these disparities will widen over time. COVID-19 testing rates in lower-income countries also lag. In high-income countries, 740 tests per 100,000 individuals are conducted daily; in low-income countries, that rate is 13 daily tests per 100,000 people. Until we can achieve more equitable access globally, the documented recovery of HIV is “precarious,” Dr. Kates said.

Ms. McGee agreed with Dr. Kates and was surprised by the extent of global inequities in the COVID-19 response. She said these issues should be a focus for the HIV health care community moving forward. “I think there are lot of us who have worked in the HIV field for many years – both domestically and internationally – who did not fully grasp the global disparities and need to consider how we can advocate for more equal access and distribution,” she said.

A version of this article first appeared on Medscape.com.

Over the past 2 years, the COVID-19 pandemic has caused numerous disruptions in health care, including in global HIV/AIDS services. But new data presented at the Association of Nurses in AIDS Care (ANAC) 2021 Annual Meeting suggest that practitioners quickly adapted to challenges posed by the pandemic, and care and prevention services around the world have begun to return to prepandemic levels.

These rebounding numbers “show how resilient the HIV system can be,” Jennifer Kates, PhD, senior vice president and director of global health and HIV policy at the Kaiser Family Foundation (KFF), said in an interview. She presented the data during her ANAC plenary talk on Nov. 11. Dr. Kates noted that continued recovery relies on improving global access to and delivery of COVID-19 vaccines. “If we do not have control of COVID, we are going to see endless cycles of impact,” she said during her talk.
 

COVID-19 and HIV services

Although there was concern that the pandemic could disrupt access to antiretrovirals, the Global Fund previously reported a nearly 9% increase in people receiving antiretroviral therapy (ART) from 2019 to 2020. HIV prevention and testing did take a hit: There was a 22% decrease in testing for HIV and an 11% decline in the number of people receiving HIV prevention services over that period.

New data from the President’s Emergency Plan for AIDS Relief (PEPFAR) showed similar trends. Consistent with the Global Fund’s findings, a KFF analysis of PEPFAR data found that the number of people receiving ART grew in 2020, climbing from 16.0 million in the first quarter (Q1) of 2020 to 17.4 million by the end of the year. The most recent data from PEPFAR suggest that the number had climbed to 18.4 million by September 2021.

However, there was a 24% decrease in the number of newly enrolled individuals receiving ART from Q2 to Q3 in 2020. It dipped from 669,436 to 509,509. There was a similar decrease in the number of people being tested for HIV, dropping 25% from an estimated 16,700 to 12,500 from Q2 to Q3. But by the end of the year, both measurements had rebounded: New enrollments in ART grew 31%, and HIV testing grew nearly 41% compared to Q3.

The DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe) program, which is focused on adolescent girls and young women, saw a dip in preexposure prophylaxis (PrEP) and other preventive services in Q4 2020, but numbers surpassed prepandemic levels by June 2021.

PEPFAR helped speed recovery, Dr. Kates said, by providing guidance on COVID-19 protocols to the field and implementing innovations, such as accelerated 3- and 6-month medication dispensing, virtual platforms, and decentralized drug delivery. In addition, the U.S. Congress allocated $3.8 billion in emergency funding in fiscal year 2021 to help mitigate the effects of COVID-19 on HIV and AIDS care.
 

Longer-term outcomes still unclear

Although these numbers are encouraging, some of the effects of COVID-19 on the HIV epidemic are still unknown – in particular, whether these documented dips in preventive services will translate to an increase in new infections. This will not be clear until a year or 2 from now, Dr. Kates noted. Increased use of ART as well as an increase in some behaviors associated with the pandemic, such as decreased social contact, are factors that mitigate an increase in the rate of infections, she said, but “how that all is going to play out we don’t know for sure.”

Other conference attendees expressed anxiety about the possibility of an increase in the rate of infections. “I’m waiting for the other shoe to drop, as it were,” Barb Cardell, training and technical assistance director at Positive Women’s Network–USA, in Oakland, Calif., said in an interview. The Positive Women’s Network is a national organization of women living with HIV. “Starting late in 2019, we have been cautioning public health officials in states and federally that there will likely be an uptick in HIV diagnosis as we return to whatever ‘normal’ looks like these days,” Ms. Cardell noted, adding, “We have all heard stories of folks that had an exposure and weren’t able to access PrEP during the pandemic and hence seroconverted.”

Kara McGee, associate clinical professor at Duke University School of Nursing, Durham, N.C., shared similar sentiments. “Many people at risk of acquiring HIV had trouble accessing testing and prevention prior to the pandemic, and service interruptions due to the COVID-19 pandemic have only worsened access – especially in rural areas,” she told this news organization.

Need for equitable vaccine access

For HIV services to continue to rebound, COVID-19 vaccination needs to be made a priority globally, Dr. Kates said. But data suggest lower-income countries are being left behind. In high-income countries, 65% of the population has been fully vaccinated, compared to 2% of people in the lowest-income countries. A KFF analysis projected that at the current rates of vaccination, these disparities will widen over time. COVID-19 testing rates in lower-income countries also lag. In high-income countries, 740 tests per 100,000 individuals are conducted daily; in low-income countries, that rate is 13 daily tests per 100,000 people. Until we can achieve more equitable access globally, the documented recovery of HIV is “precarious,” Dr. Kates said.

Ms. McGee agreed with Dr. Kates and was surprised by the extent of global inequities in the COVID-19 response. She said these issues should be a focus for the HIV health care community moving forward. “I think there are lot of us who have worked in the HIV field for many years – both domestically and internationally – who did not fully grasp the global disparities and need to consider how we can advocate for more equal access and distribution,” she said.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has given the green light to third, or booster doses of the Pfizer and Moderna vaccines for everyone over the age of 18, ahead of the busy winter holiday season.

“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said acting FDA Commissioner Janet Woodcock, MD, in an FDA press statement.

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster doses, and is expected to vote on official recommendations for their use in the United States. The CDC director must then sign off on the panel’s recommendations.

“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Rochelle P. Walensky, MD, MPH, said at a recent White House briefing.

Several states – including Louisiana, Maine, and Colorado – have already authorized boosters for all adults as cases rise in Europe and across the Western and Northeastern regions of the United States.

FDA officials said they hoped that widening eligibility for boosters would cut down on confusion for people and hopefully speed uptake of the shots.

“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research.

A version of this article first appeared on WebMD.com.

The Food and Drug Administration has given the green light to third, or booster doses of the Pfizer and Moderna vaccines for everyone over the age of 18, ahead of the busy winter holiday season.

“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said acting FDA Commissioner Janet Woodcock, MD, in an FDA press statement.

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster doses, and is expected to vote on official recommendations for their use in the United States. The CDC director must then sign off on the panel’s recommendations.

“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Rochelle P. Walensky, MD, MPH, said at a recent White House briefing.

Several states – including Louisiana, Maine, and Colorado – have already authorized boosters for all adults as cases rise in Europe and across the Western and Northeastern regions of the United States.

FDA officials said they hoped that widening eligibility for boosters would cut down on confusion for people and hopefully speed uptake of the shots.

“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research.

A version of this article first appeared on WebMD.com.

The Food and Drug Administration has given the green light to third, or booster doses of the Pfizer and Moderna vaccines for everyone over the age of 18, ahead of the busy winter holiday season.

“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said acting FDA Commissioner Janet Woodcock, MD, in an FDA press statement.

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster doses, and is expected to vote on official recommendations for their use in the United States. The CDC director must then sign off on the panel’s recommendations.

“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Rochelle P. Walensky, MD, MPH, said at a recent White House briefing.

Several states – including Louisiana, Maine, and Colorado – have already authorized boosters for all adults as cases rise in Europe and across the Western and Northeastern regions of the United States.

FDA officials said they hoped that widening eligibility for boosters would cut down on confusion for people and hopefully speed uptake of the shots.

“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research.

A version of this article first appeared on WebMD.com.