Managing Complex Acute Otitis Media Infections
Most acute otitis media (AOM) infections resolve without complications, whether treated with antibiotics or observed under 'watchful waiting.' In recent years, these infections have been termed uncomplicated AOM. However, some children have more serious infections, and these infections have been termed complex AOM.
Michael E. Pichichero, MD
Children with complex AOM have become a focus of investigation by those doing research in the otitis media field, driven by the recognition that these children experience greater consequences from infections, and their medical management accounts for more than half the costs of care associated with AOM.
Complex AOM may be defined according to five differing clinical presentations: 1) recurrent AOM (defined as children with three AOM episodes within 6 months or = 4 AOM episodes within 12 months), ie, otitis prone; 2) treatment failure (second AOM episode occurring within 14 days from an initial AOM visit); 3) relapsed AOM (second AOM episode occurring > 2 weeks from the initial AOM visit but < 1 month from an initial otitis media episode; 4) eardrum rupture; and 5) AOM with local or systemic complications such as mastoiditis, intracranial abscess, or facial nerve palsy.
The frequency of the complex AOM types above are ranked from most to least frequent in the US and other high-income countries. In low- and middle-income countries — where AOM is infrequently diagnosed by clinicians — the frequency of presentation is quite different, with the more common being eardrum rupture and AOM with complications.
My group recently reported results of an 18-year longitudinal study of uncomplicated and complex AOM, spanning 2006-2023, during the 7-valent pneumococcal conjugate vaccine (PCV7) era and throughout the 13-valent PCV (PCV13) era. We enrolled 1537 children prospectively, usually at 6 months old, and followed them to 36 months.
When clinicians made the clinical diagnosis of AOM, tympanocentesis was performed for middle ear fluid culture in most cases. We used the electronic medical records retrospectively to identify uncomplicated AOM and complex AOM episodes. As an inclusion criterion, all children were required to receive the full primary series of PCV7 or PCV13 immunizations according to US Centers for Disease Control and Prevention schedule (doses at 2, 4, and 6, months; booster dose between 12 and 15 months).
Classification of complex AOM was made on an episode basis. If the child met the definition of recurrent AOM, all AOM episodes with middle ear fluid collection were included in the complex AOM group for analysis purposes. One hundred ninety-two children were vaccinated with PCV7 during 2006-2009. Children who received PCV13 immunizations were divided into two groups: 404 children in what we called the early PCV13 era (2010-2014), and 525 children in what we called the late PCV13 era ( 2015-2023).
Among the 1537 enrolled children, the first thing we found is that 591 never had an AOM episode (No OM group, 53%). In the 1980s, 80% of young children were said to have at least one AOM, compared to our new result of 53%. Whether the surprisingly low frequency of AOM was due to PCVs, or changes in the clinical diagnostic criteria for AOM promulgated by the American Academy of Pediatrics in their AOM guidelines, or because parents decreased the frequency of how often they sought care for ear pain in their children, is unknown.
Of the 530 children with at least one episode of AOM, we found that 53% had uncomplicated AOM, 34% had complex AOM, and 13% had both uncomplicated AOM and complex AOM. To our knowledge, this was the first comprehensive report from primary care practices in the US of this distribution of cases of uncomplicated vs complex AOM. Risk factors for complex AOM compared with uncomplicated AOM were male sex, family history of AOM, and daycare attendance.
We found that the frequency of isolating pneumococci from middle ear fluid in episodes of complex AOM decreased over time, between 2006 and 2023. The frequency of isolating Haemophilus influenzae and Moraxella catarrhalis did not change over time. Since pneumococci isolation went down and H influenzae isolation stayed the same, H influenzae became the predominant organism causing complex AOM throughout both PCV13 timespans we studied. Among uncomplicated episodes of AOM, pneumococcal isolation from middle ear fluid remained the same, whereas isolation of H influenzae went up and M catarrhalis went down. Isolation of H influenzae was 44% more likely in children with complex AOM vs uncomplicated AOM. This is consistent with the association between H influenzae and complex AOM, particularly recurrent AOM, as previously reported.
PCV13 significantly reduced the isolation from middle ear fluid strains of pneumococci-expressing various capsular polysaccharide serotypes, throughout the entire timespan that PCV13 was used. The result was consistent with our earlier report in Lancet Child and Adolescent Health , when we studied the effectiveness of PCV13 shortly after its introduction in 2010. However, consistent with a wide literature, over time, pneumococci-expressing PCV13 serotypes were replaced by organisms expressing other serotypes not in the vaccine, especially serotype 35B in the late PCV13 era.
In terms of antibiotic susceptibility, the odds of antibiotic nonsusceptibility of pneumococci to penicillin were 2.65 times higher in children with complex AOM compared to children experiencing uncomplicated AOM. The proportion of H influenzae that was beta lactamase-producing (amoxicillin resistant) increased during the PCV13 eras compared to the PCV7 era.
Key Points:
Risk factors for developing complex AOM and uncomplicated AOM are similar.
PCV13 significantly reduced complex AOM and penicillin nonsusceptibility associated with pneumococci driven by near complete elimination of strains expressing serotype 19A.
H influenzae is the dominant cause of complex AOM.
is the dominant cause of complex AOM. Although non-PCV13 pneumococcal serotypes emerged in the late PCV13 era, the lower level of complex AOM caused by pneumococci remained lower compared to the PCV7 era.
Rochester General Hospital Research Institute was the study sponsor/co-funder and Pfizer provided additional funding for the study analysis that resulted in this paper: N Fuji et al. Eighteen-year longitudinal study of uncomplicated and complex acute otitis media during the pneumococcal conjugate vaccine era, 2006-2023. The Journal of Infectious Diseases , 2025.
Funding was provided by the National Institute on Deafness and Other Communication Disorders of the National Institutes of Health and the Centers for Disease Control and Prevention for the collection of middle ear samples leading to the publication.
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Yahoo
37 minutes ago
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These dads lost everything, and then they found each other
The worst day of Brad Bailey's life was March 5, 2020: the day his son, Rhoan, was stillborn at 39 weeks old. His wife, Erica Bailey, had experienced a routine pregnancy until that day. No issues, no extra monitoring necessary. That morning, however, something was awry. The baby had stopped moving, and she went straight to the hospital. An ultrasound confirmed the couple's worst fear: The baby didn't have a heartbeat. Rhoan was declared dead before the Baileys ever got a chance to meet him. In the days and weeks that followed, the couple did the best they could to honor their son. They had a funeral near their home in Kansas City, Missouri. They took time off from work. Erica Bailey began to find comfort and purpose in volunteering for a nonprofit that advocates for stillbirth prevention, but Brad, 38, was still stupefied by sadness. 'Burying your child is something that only those who have been around it or experienced it can understand,' he said. 'I felt like I had nobody to talk to and no way out.' Eventually, upon a recommendation from his wife, Bailey connected with an online organization called the Sad Dads Club, a nonprofit that provides peer-to-peer community and support for bereaved fathers. The club supports dads who have endured any type of perinatal loss – that is, death of a baby during pregnancy, labor or within the first few weeks after birth. The group also welcomes fathers who have lost children to sudden infant death syndrome and those who have lost older and even adult children. It helps dads by providing a safe space for them to grieve, said Rob Reider, a club cofounder and executive director. The men share heartache, fear, anger, confusion, joy and any other emotion they experience on their journey. They also trade insights, knowledge and advice. Most of the group's meetups are virtual: either via weekly video calls or messaging on the SDC Discord channel. 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While there are mental health programs to help parents manage this heartbreak, most of them are for mothers, said Michelle Goldwin Kaufman, a psychologist in Memphis, Tennessee. Kaufman noted this means dads are left to manage heartache on their own. It's yet another challenge, considering that traditional masculinity norms reject vulnerability and that men's mental health has been in crisis. 'One of the stereotypes is that men want to fix things, but stillbirth is not a problem anyone can fix,' said Kaufman, who is also an adjunct professor of psychology at the University of Memphis. 'The reality is that dads in these scenarios often get forgotten, and it's important to create an environment where they can give their grief space.' This need for connection is precisely what led 40-year-old Reider to team up with friends Jay Tansey and Chris Piasecki and start the Sad Dads Club. 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Medscape
a day ago
- Medscape
Managing Complex Acute Otitis Media Infections
Most acute otitis media (AOM) infections resolve without complications, whether treated with antibiotics or observed under 'watchful waiting.' In recent years, these infections have been termed uncomplicated AOM. However, some children have more serious infections, and these infections have been termed complex AOM. Michael E. Pichichero, MD Children with complex AOM have become a focus of investigation by those doing research in the otitis media field, driven by the recognition that these children experience greater consequences from infections, and their medical management accounts for more than half the costs of care associated with AOM. Complex AOM may be defined according to five differing clinical presentations: 1) recurrent AOM (defined as children with three AOM episodes within 6 months or = 4 AOM episodes within 12 months), ie, otitis prone; 2) treatment failure (second AOM episode occurring within 14 days from an initial AOM visit); 3) relapsed AOM (second AOM episode occurring > 2 weeks from the initial AOM visit but < 1 month from an initial otitis media episode; 4) eardrum rupture; and 5) AOM with local or systemic complications such as mastoiditis, intracranial abscess, or facial nerve palsy. The frequency of the complex AOM types above are ranked from most to least frequent in the US and other high-income countries. In low- and middle-income countries — where AOM is infrequently diagnosed by clinicians — the frequency of presentation is quite different, with the more common being eardrum rupture and AOM with complications. My group recently reported results of an 18-year longitudinal study of uncomplicated and complex AOM, spanning 2006-2023, during the 7-valent pneumococcal conjugate vaccine (PCV7) era and throughout the 13-valent PCV (PCV13) era. We enrolled 1537 children prospectively, usually at 6 months old, and followed them to 36 months. When clinicians made the clinical diagnosis of AOM, tympanocentesis was performed for middle ear fluid culture in most cases. We used the electronic medical records retrospectively to identify uncomplicated AOM and complex AOM episodes. As an inclusion criterion, all children were required to receive the full primary series of PCV7 or PCV13 immunizations according to US Centers for Disease Control and Prevention schedule (doses at 2, 4, and 6, months; booster dose between 12 and 15 months). Classification of complex AOM was made on an episode basis. If the child met the definition of recurrent AOM, all AOM episodes with middle ear fluid collection were included in the complex AOM group for analysis purposes. One hundred ninety-two children were vaccinated with PCV7 during 2006-2009. Children who received PCV13 immunizations were divided into two groups: 404 children in what we called the early PCV13 era (2010-2014), and 525 children in what we called the late PCV13 era ( 2015-2023). Among the 1537 enrolled children, the first thing we found is that 591 never had an AOM episode (No OM group, 53%). In the 1980s, 80% of young children were said to have at least one AOM, compared to our new result of 53%. Whether the surprisingly low frequency of AOM was due to PCVs, or changes in the clinical diagnostic criteria for AOM promulgated by the American Academy of Pediatrics in their AOM guidelines, or because parents decreased the frequency of how often they sought care for ear pain in their children, is unknown. Of the 530 children with at least one episode of AOM, we found that 53% had uncomplicated AOM, 34% had complex AOM, and 13% had both uncomplicated AOM and complex AOM. To our knowledge, this was the first comprehensive report from primary care practices in the US of this distribution of cases of uncomplicated vs complex AOM. Risk factors for complex AOM compared with uncomplicated AOM were male sex, family history of AOM, and daycare attendance. We found that the frequency of isolating pneumococci from middle ear fluid in episodes of complex AOM decreased over time, between 2006 and 2023. The frequency of isolating Haemophilus influenzae and Moraxella catarrhalis did not change over time. Since pneumococci isolation went down and H influenzae isolation stayed the same, H influenzae became the predominant organism causing complex AOM throughout both PCV13 timespans we studied. Among uncomplicated episodes of AOM, pneumococcal isolation from middle ear fluid remained the same, whereas isolation of H influenzae went up and M catarrhalis went down. Isolation of H influenzae was 44% more likely in children with complex AOM vs uncomplicated AOM. This is consistent with the association between H influenzae and complex AOM, particularly recurrent AOM, as previously reported. PCV13 significantly reduced the isolation from middle ear fluid strains of pneumococci-expressing various capsular polysaccharide serotypes, throughout the entire timespan that PCV13 was used. The result was consistent with our earlier report in Lancet Child and Adolescent Health , when we studied the effectiveness of PCV13 shortly after its introduction in 2010. However, consistent with a wide literature, over time, pneumococci-expressing PCV13 serotypes were replaced by organisms expressing other serotypes not in the vaccine, especially serotype 35B in the late PCV13 era. In terms of antibiotic susceptibility, the odds of antibiotic nonsusceptibility of pneumococci to penicillin were 2.65 times higher in children with complex AOM compared to children experiencing uncomplicated AOM. The proportion of H influenzae that was beta lactamase-producing (amoxicillin resistant) increased during the PCV13 eras compared to the PCV7 era. Key Points: Risk factors for developing complex AOM and uncomplicated AOM are similar. PCV13 significantly reduced complex AOM and penicillin nonsusceptibility associated with pneumococci driven by near complete elimination of strains expressing serotype 19A. H influenzae is the dominant cause of complex AOM. is the dominant cause of complex AOM. Although non-PCV13 pneumococcal serotypes emerged in the late PCV13 era, the lower level of complex AOM caused by pneumococci remained lower compared to the PCV7 era. Rochester General Hospital Research Institute was the study sponsor/co-funder and Pfizer provided additional funding for the study analysis that resulted in this paper: N Fuji et al. Eighteen-year longitudinal study of uncomplicated and complex acute otitis media during the pneumococcal conjugate vaccine era, 2006-2023. The Journal of Infectious Diseases , 2025. Funding was provided by the National Institute on Deafness and Other Communication Disorders of the National Institutes of Health and the Centers for Disease Control and Prevention for the collection of middle ear samples leading to the publication.
Yahoo
a day ago
- Yahoo
New federal Covid-19 vaccine policies are already keeping some people from getting shots
After federal health officials made abrupt changes to US Covid-19 vaccine recommendations for pregnant women last month, there's new confusion and uncertainty about who can get the shots — and some reports that patients were turned away when they tried to get vaccinated. Now, 30 health and medical organizations are pushing for continued access and insurance coverage for the vaccines. 'We are deeply concerned about the recently adopted HHS policy to no longer recommend COVID-19 vaccination during pregnancy,' wrote the organizations – including major professional groups for obstetricians, primary care providers, pediatricians, pharmacists and nurses – in an open letter. 'It is vital that we ensure that pregnant women continue to have access to this prevention tool so that they can protect themselves and their young infants, a vulnerable group who is not yet eligible for vaccination.' The letter calls on 'payers and insurers to continue making the COVID-19 vaccine available to pregnant people without undue utilization management or cost-sharing requirements,' even though the shots have been removed from the list of vaccines recommended by the US Centers for Disease Control and Prevention. Pregnant women who have Covid-19 are more likely to require care in the ICU or on a ventilator, or to die, the letter said, and they're at higher risk of complications such as cesarean birth, preeclampsia or eclampsia, and blood clots. Infants born after a Covid-19 infection also face increased risks. The letter comes two weeks after US Health and Human Services Secretary Robert F. Kennedy Jr. abruptly announced that the Covid-19 vaccine, which has shown to be safe and effective during pregnancy, would no longer be recommended for pregnant people. Leaders from the US Food and Drug Administration also recently outlined a new framework for the approval process for Covid-19 vaccines that could limit shots to older Americans and people at higher risk of serious Covid-19 infection. Experts immediately warned that these changes could create new barriers to vaccines for those who want them, including confusion around who is eligible and higher costs for patients if insurance no longer covers them. The American Pharmacists Association, which signed on to the open letter, said it has already received reports of patients being denied Covid-19 vaccines. Leigh Haldeman, 33, a nurse at Harborview Medical Center in Seattle who is pregnant, told CNN that she tried twice to get vaccinated last week and was turned away. 'Because of some complications I had during my first pregnancy, getting the vaccine now and getting that extra boost of immunity would be definitely important for me,' said Haldeman, who got her last shot in the fall of 2024. At two different pharmacies, she was told it is not recommended for pregnant women to receive the Covid-19 vaccine, based on new guidelines. She still hasn't been able to get the shot. Many doctors still strongly recommend Covid-19 vaccination during pregnancy. 'Despite the change in recommendations from HHS, the science has not changed,' the American College of Obstetricians and Gynecologists said in a statement. 'It is very clear that COVID-19 infection during pregnancy can be catastrophic and lead to major disability, and it can cause devastating consequences for families. The COVID-19 vaccine is safe during pregnancy, and vaccination can protect our patients and their infants after birth.' After an appointment last week, Haldeman agreed with her obstetrician's advice to get an additional Covid-19 shot during her pregnancy. Her first try was a Walgreens store where she had an appointment to get the vaccine. 'I went through the whole check-in process, and then as soon as the pharmacist saw that I was pregnant, they were like, 'We cannot give this to you,' ' she recounted. ' 'We're only giving it to immunocompromised people right now.' ' She said she asked whether she was considered immunocompromised because she's pregnant. Haldeman said the pharmacist responded that guidelines have changed, that it's not recommended and they wouldn't give it to her. She then called her primary care provider and obstetrician, but neither had the vaccine in stock. In past years, pharmacies have administered the majority of Covid-19 shots. A Walgreens spokesperson told CNN, 'We continue to closely monitor and review all federal and state guidance related to vaccines. As regulations and recommendations evolve, we remain committed to ensuring our pharmacy teams have the latest information to support patient care.' Haldeman said her obstetrician suggested trying another pharmacy. She called a Safeway and asked, 'I'm 25 weeks pregnant. My provider is recommending that I get this Covid booster. Are you able to give that to me?' The immediate answer was no. 'I'm under the impression from my provider that I need to get this,' she recalled saying. 'Pharmacies are the only people that appear to have it right now. What do I need to do to get this vaccine?' She said the pharmacist told her, 'The guidelines have changed as of last Friday. We can't give it to you.' The pharmacist suggested that Haldeman try getting a prescription for the vaccine from her provider so the pharmacy might be able to administer it. Her obstetrician wrote a vaccination prescription and sent it to the Safeway pharmacy, but when Haldeman visited the location at 7 p.m. the same day, she was told the pharmacy hadn't received the prescription. In a statement from a company spokesperson, Safeway parent company Albertsons told CNN, 'In accordance with recently updated CDC guidance, we adjusted our COVID-19 vaccination policies. Pregnant individuals with specific medical conditions that increase their risk of severe illness remain eligible for vaccination. We encourage all customers to consult with their healthcare providers for personalized advice.' The lack of clarity left Haldeman frustrated and uncertain about what to do next. 'I spent half my day on this. … Most people are probably not going to go to those lengths to get the vaccine. The more hoops that you make people jump through, less and less people are just going to get vaccinated,' Haldeman said. 'And we know that having Covid during pregnancy does terrible things to your placenta, and certainly reducing that risk is worth it. So it's very frustrating.' The American Pharmacists Association said in a news release that the updates to the Covid-19 recommendations 'do not appear to be based on the scientific evidence provided over the past few years. … COVID-19 vaccination during pregnancy has been proven safe and effective.' However, pharmacists 'may face consequences if they do not follow the Advisory Committee on Immunization Practices or CDC recommendations,' said Allison Hill, the association's director of professional affairs. 'HHS's and CDC's recent changes to the Covid-19 recommendations create barriers and confusion,' Hill said. HHS's unusual updates to the Covid-19 vaccine schedules were followed this week by a sweeping change to the CDC's Advisory Committee on Immunization Practices, the independent experts who typically guide the agency on its vaccine recommendations. Kennedy bypassed ACIP in making the Covid-19 changes and then said this week that he had dismissed the entire 17-member panel. On Wednesday, Kennedy announced eight new members to ACIP. The removal of the vaccine advisers sparked a swift backlash from health care providers and professional organizations. Dr. Tina Tan, president of the Infectious Diseases Society of America, another organization that signed the open letter, said that undermining the integrity of ACIP is 'completely unfounded' and has 'a significant negative impact on Americans of all ages.' The pharmacists association said Tuesday, 'It is highly concerning that removing 17 scientists overnight eliminates the historical knowledge, scientific training, and clinical expertise required to equip pharmacists and the public to make appropriate choices for health based upon the risk.' Since Kennedy announced changes to the Covid-19 vaccine schedule, doctors said they're worried about their patients and the future of vaccinations. 'We are worried about our patients in the future, who may be less likely to choose vaccination during pregnancy despite the clear and definitive evidence demonstrating its benefit,' Dr. Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists, said in a statement. 'We are concerned about access implications and what this recommendation will mean for insurance coverage of the COVID-19 vaccine for those who do choose to get vaccinated during pregnancy. And as ob-gyns, we are very concerned about the potential deterioration of vaccine confidence in the future.' Studies have shown that infants who are born after a Covid-19 infection during pregnancy are at increased risk of stillbirth, respiratory distress and low birth weight. 'With maternal health being compromised, you have the risk for preterm delivery, babies that are born very small or potentially even fetal loss early on,' Dr. Flor Munoz-Rivas, an associate professor of pediatrics and infectious disease at Baylor College of Medicine, said last week. Dr. John Lynch, an associate medical director at the Harborview Medical Center and a colleague of Haldeman's, said Covid-19 vaccination during pregnancy also has benefits for the newborn. 'Vaccinating a mom leads to the protection of the baby when they don't have their own immune response,' Lynch said. Since the Covid vaccine is not available to babies younger than 6 months, vaccinating the mother may be the safest way for young children to gain some immunity. 'That first year of life remains the highest period of risk, and this is a vaccine-preventable disease,' Muñoz said. 'We can modify the outcomes for these babies through maternal vaccination and through infant vaccination.'
