vaccination

Importance: Hepatitis B virus (HBV) infection affects an estimated 254 million people worldwide and causes approximately 1.1 million deaths annually. In 2022, there were approximately 1.2 million new HBV infections worldwide and 14 000 in the US.

Observations: HBV is a DNA virus transmitted through percutaneous or mucosal exposure to infected blood, semen, or body fluids. Mother-to-child transmission, which is the principal cause of chronic HBV infection globally, occurs in 70% to 90% of infants born to mothers who are hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) positive and in 5% to 20% of those born to HBsAg-positive/HBeAg-negative mothers. However, HBV vaccination and administration of hepatitis B immune globulin within 12 to 24 hours of birth prevent approximately 94% of perinatal infections, and adding antiviral therapy in pregnant women with high HBV DNA reduces transmission to less than 1%. Although universal birth-dose HBV vaccination is the most effective strategy for eliminating HBV infection, global birth-dose HBV vaccine coverage was only 45% in 2024. The risk of developing chronic infection (HBsAg positive for more than 6 months) is 90% if HBV infection occurs during infancy, 30% in children aged 1 to 5 years, and less than or equal to 5% in immunocompetent adolescents and adults. HBV infection is diagnosed by serologic testing: HBsAg indicates ongoing infection, antibody to HBsAg indicates immunity, and antibody to hepatitis B core antigen indicates ongoing or past infection. Serum HBV DNA levels quantify virus-replication activity. Assessment of liver inflammation and fibrosis with alanine aminotransferase (ALT) and noninvasive tests such as Fibrosis-4 index and liver elastography guide treatment decisions. Chronic HBV infection may progress to cirrhosis and hepatocellular carcinoma (HCC); the 5-year cumulative risk of cirrhosis is 8% to 15% in untreated chronic HBV infection, and annual HCC incidence is 3% to 5% among patients with cirrhosis. Antiviral therapies-pegylated interferon alfa and nucleos(t)ide analogues (entecavir or tenofovir)-suppress HBV DNA replication and reduce the risk of HCC by approximately 50%. Antiviral treatment is recommended for all patients with chronic HBV and cirrhosis and for those without cirrhosis who have high HBV DNA with elevated ALT or significant inflammation/fibrosis. Patients at high risk of HCC should undergo surveillance with ultrasonography and alpha-fetoprotein testing every 6 months.

Conclusions and relevance: HBV infection causes approximately 1.1 million deaths annually worldwide. Universal HBV vaccination, particularly birth-dose administration, is the most effective strategy to prevent HBV infection. Among patients with HBV infection, antiviral therapy decreases progression to cirrhosis and liver failure and reduces the risk of HCC.

Author/s:

Wen-Juei Jeng, Terry Cheuk-Fung Yip, Anna S. Lok

Addressing Faith-Based Concerns about Vaccination

Hope Smashey — Wed, 26 Nov 2025 02:16:02 +0000

Date Added:

November 25, 2025

Publisher:

J Am Board Fam Med .

Publication Date:

November 24, 2025

Issue:

Volume:

Pages:

732-734

URL:

Addressing Faith-Based Concerns about Vaccination

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.3122/jabfm.2025.250038R1

Keywords

PMID (1):

41115758

MeSH

Spirituality

Vaccination Hesitancy

Educational Status

vaccination

vaccines

Research-based recommendations for addressing faith-based concerns about immunizations. James W. Mold, MD, MPH

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Religious beliefs are cited as one cause of declining vaccination rates, and religious participation has been associated with hesitancy to receive vaccines. However, many personal vaccine objections attributed to faith-based reasons are more likely matters of personal faith interpretation rather than based on the teachings or traditions of a religious community. Studies have demonstrated ways faith-based hesitancy or skepticism toward vaccines can be addressed at both the individual level and the community level. Evidence to date suggests faith-based vaccine hesitancy and may be best approached through education that addresses and accounts for the patient's spirituality, and by collaboration with organizations that are connected to patients' religious communities.

Author/s:

William E Cayley Jr

An Evidence-Based Approach to Covid-19 Vaccination

Alex Haga — Tue, 27 May 2025 13:16:39 +0000

Date Added:

May 27, 2025

Journal/Publication:

NEJM

Publication Date:

May 20, 2025

URL:

An Evidence-Based Approach to Covid-19 Vaccination

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1056/NEJMsb2506929

Keywords

COVID-19

vaccination

Policy

PMID (1):

40392534

MeSH

COVID-19

vaccination

Policy

An evidence-based review and recommendations regarding COVID vaccination. James W. Mold, MPH

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No abstract available.

Author/s:

Vinay Prasad, Martin A Makary

Measles

Erin Blanchette — Mon, 06 May 2024 17:34:23 +0000

Date Added:

May 6, 2024

Journal/Publication:

Canadian Medical Association Journal

Publisher:

Canadian Medical Association

Publication Date:

April 21, 2024

Issue:

Volume:

196

Pages:

E524

URL:

Measles

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1503/cmaj.240415

Keywords

measles

Immunity

vaccination

vaccination recommendations

PMID (1):

38649173

MeSH

Travel-Related Illness

measles virus

A review of measles for those too young to remember. James W. Mold, MD, MPH

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Canada has had measles elimination status since 1998 but remains vulnerable to outbreaks

Increased measles activity globally raises the risk of travel-related cases in Canada, which can spread rapidly in underimmunized communities.

Author/s:

Sarah E Wilson, Marina I Salvadori, Michelle Science

Recommended Immunizations for Children 7–18 Years Old, United States, 2024

Erin Blanchette — Tue, 30 Apr 2024 16:41:13 +0000

Date Added:

April 30, 2024

Journal/Publication:

Centers for Disease Control and Prevention

Publisher:

U.S. Department of Health & Human Services

Publication Date:

March 18, 2024

URL:

Type:

Public Health Announcements

Format:

Web Page

Keywords

Immunization

Immunization Schedule

vaccination

vaccination recommendations

MeSH

child

adolescent

Vaccine-Preventable Diseases

Up-to-date immunization recommendations for children 7 - 18 years old. James W. Mold, MD, MPH

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This parent-friendly schedule is recommended by the Advisory Committee on Immunization Practices (ACIP) and approved by the Centers for Disease Control and Prevention (CDC), American Academy of Pediatrics (AAP), and American Academy of Family Physicians (AAFP).

Recommended Immunizations for Birth Through 6 Years Old, United States, 2024

Erin Blanchette — Tue, 30 Apr 2024 16:22:38 +0000

Date Added:

April 30, 2024

Journal/Publication:

Centers for Disease Control and Prevention

Publisher:

U.S. Department of Health & Human Services

Publication Date:

March 18, 2024

URL:

Type:

Public Health Announcements

Format:

Web Page

Keywords

Immunization Schedule

Immunization

vaccination

vaccination recommendations

MeSH

child

child, preschool

Vaccine-Preventable Diseases

Up-to-date immunization recommendations for children from birth to 6 years. James W. Mold, MD, MPH

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A Hitchhiker's Guide to Worldwide COVID-19 Vaccinations: A Detailed Review of Monovalent and Bivalent Vaccine Schedules, COVID-19 Vaccine Side Effects, and Effectiveness Against Omicron and Delta Variants

Aubrey Delammermore — Sun, 09 Oct 2022 05:00:00 +0000

Date Added:

October 9, 2022

Journal/Publication:

Cureus

Publisher:

Cureus

Publication Date:

October 2, 2022

Issue:

Volume:

URL:

A Hitchhiker's Guide to Worldwide COVID-19 Vaccinations: A Detailed Review of Monovalent and Bivalent Vaccine Schedules, COVID-19 Vaccine Side Effects, and Effectiveness Against Omicron and Delta Variants

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.7759/cureus.29837

Keywords

Cost-Benefit Analysis

PMID (1):

36204257

MeSH

Centers for Disease Control and Prevention, U.S.

delivery of health care

A summary of recommended dosing intervals and effectiveness of currently available COVID-19 vaccines. James W. Mold, MD, MPH

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For the primary prevention of coronavirus disease 2019 (COVID-19), there are currently four different vaccines available in the USA. These are Pfizer (messenger RNA [mRNA]), Moderna (mRNA), Novavax (recombinant protein), and Jansen/Johnson & Johnson (adenoviral vector). All individuals should get vaccinated, and the Centers for Disease Control and Prevention (CDC) has provided comprehensive guidelines on recommended doses, their frequency by age group, and vaccine types, all discussed in detail in this article. Vaccines are a critical and cost-effective tool for preventing the disease. Prior to receiving a vaccine, patients should get adequate counseling regarding any potential adverse effects post vaccination. Appropriate safety precautions must be taken for those more likely to experience adverse consequences. Healthcare professionals should be aware of the symptoms, indicators, and treatment of any adverse event post-vaccination. We have provided a comprehensive review of the different characteristics of COVID-19 vaccines available in the United States, including their effectiveness against various variants, adverse effects, and precautions necessary for healthcare professionals and the general population. This article also briefly covers COVID-19 vaccines available worldwide, specifically their mode of action and effectiveness.

Author/s:

Goyal, L., Zapata, M., Ajmera, K., Churasia, P., Pandit, R., Pandit, T.

Association of Influenza Vaccination With Cardiovascular Risk: A Meta-analysis

Saige Blanchard — Tue, 10 May 2022 05:00:00 +0000

Date Added:

May 10, 2022

Journal/Publication:

JAMA Network Open

Publisher:

JAMA Network Open

Publication Date:

April 29, 2022

Issue:

Volume:

Pages:

1-9

URL:

Association of Influenza Vaccination With Cardiovascular Risk: A Meta-analysis

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1001/jamanetworkopen.2022.8873

Keywords

PMID (1):

35486404

MeSH

influenza vaccines

acute coronary syndrome

Odds Ratio

COVID-19

follow-up studies

It appears that the influenza vaccine somehow reduces the risk of cardiovascular events over the subsequent year by almost 2%, which is about as effective as lowering blood pressure in older people. At the very least, it could be another way to convince people to get immunized. James W. Mold, MD, MPH

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Importance: Influenza infection is associated with increased cardiovascular hospitalization and mortality. Our prior systematic review and meta-analysis hypothesized that influenza vaccination was associated with a lower risk of cardiovascular events.

Objective: To evaluate, via an updated meta-analysis, if seasonal influenza vaccination is associated with a lower risk of fatal and nonfatal cardiovascular events and assess whether the newest cardiovascular outcome trial results are consistent with prior findings.

Data sources: A previously published meta-analysis of randomized controlled trials (RCTs) and a large 2021 cardiovascular outcome trial.

Study selection: Studies with RCTs published between 2000 and 2021 that randomized participants to either influenza vaccine or placebo/control. Eligible participants were inpatients and outpatients recruited for international multicenter RCTs and randomized to receive either influenza vaccine or placebo/control.

Data extraction and synthesis: PRISMA guidelines were followed in the extraction of study details, and risk of bias was assessed using the Cochrane Collaboration tool. Trial quality was evaluated using Cochrane criteria. Data were analyzed January 2020 and December 2021.

Main outcomes and measures: Random-effects Mantel-Haenszel risk ratios (RRs) and 95% CIs were derived for a composite of major adverse cardiovascular events and cardiovascular mortality within 12 months of follow-up. Where available, analyses were stratified by patients with and without recent acute coronary syndrome (ACS) within 1 year of randomization.

Results: Six published RCTs comprising a total of 9001 patients were included (mean age, 65.5 years; 42.5% women; 52.3% with a cardiac history). Overall, influenza vaccine was associated with a lower risk of composite cardiovascular events (3.6% vs 5.4%; RR, 0.66; 95% CI, 0.53-0.83; P < .001). A treatment interaction was detected between patients with recent ACS (RR, 0.55; 95% CI, 0.41-0.75) and without recent ACS (RR, 1.00; 95% CI, 0.68-1.47) (P for interaction = .02). For cardiovascular mortality, a treatment interaction was also detected between patients with recent ACS (RR, 0.44; 95% CI, 0.23-0.85) and without recent ACS (RR, 1.45; 95% CI, 0.84-2.50) (P for interaction = .006), while 1.7% of vaccine recipients died of cardiovascular causes compared with 2.5% of placebo or control recipients (RR, 0.74; 95% CI, 0.42-1.30; P = .29).

Conclusions and relevance: In this study, receipt of influenza vaccination was associated with a 34% lower risk of major adverse cardiovascular events, and individuals with recent ACS had a 45% lower risk. Given influenza poses a threat to population health during the COVID-19 pandemic, it is integral to counsel high-risk patients on the cardiovascular benefits of influenza vaccination.

Author/s:

Behrouzi, B., Bhatt, D. L., Cannon, C. P., Vardeny, O., Lee, D. S., Solomon, S. D., Udell, J. A.

RNA vaccines: a novel technology to prevent and treat disease

Brian Desmarais — Mon, 16 Nov 2020 20:47:39 +0000

Date Added:

November 16, 2020

Journal/Publication:

Science in the News Blog

Publisher:

Harvard University

Publication Date:

May 1, 2015

URL:

RNA vaccines: a novel technology to prevent and treat disease

Type:

Patient Education Materials

Keywords

An explanation of how mRNA vaccines work including their advantages and disadvantages. James W. Mold, MD, MPH

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Not available.

Author/s:

Hubaud, A.

Human Papillomavirus Immunization in Rural Primary Care

Brian Desmarais — Mon, 29 Jun 2020 17:01:39 +0000

Date Added:

June 29, 2020

Journal/Publication:

American Journal of Preventive Medicine

URL:

Human Papillomavirus Immunization in Rural Primary Care

Type:

Best Local Practices

Format:

Article

DOI (1):

https://doi.org/10.1016/j.amepre.2020.03.018

Keywords

vaccination

MeSH

Papillomavirus Infections

Papillomavirus Vaccines

The results might be helpful to practices trying to increase HPV immunization rates. James W. Mold, MD, MPH

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Not available.

Author/s:

Gunn, R., Ferrara, L.K., Dickinson, C., Fagnan, L.J., Carney, P.A., Davis, M.M.

Immunization Strategies to Span the Spectrum of Immunocompromised Adults

John Bayhi — Sat, 15 Feb 2020 20:43:08 +0000

Date Added:

February 15, 2020

Journal/Publication:

Mayo Clinic Proceedings

Publisher:

Elsevier, Inc.

Publication Date:

February 14, 2020

Type:

Meta-analyses, Reviews, and Guidelines

DOI (1):

10.1016/j.mayocp.2019.09.002

Keywords

MeSH

Immunogenicity, Vaccine

Centers for Disease Control and Prevention, U.S.

risk assessment

This is a concise review of the principles involved in the immunization of patients who are immunocompromised. James W. Mold, MD, MPH

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The Advisory Committee on Immunization Practices to the US Centers for Disease Control and Prevention provides annual recommendations for routine adult immunizations. Many recommendations consider patient factors such as age, medical conditions, and medications that increase an individual’s risk for infection with a vaccine-preventable disease. These factors, particularly those that lead to immunocompromise, may also alter the risk-benefit ratio for live vaccines, and/or lead to decreased vaccine immunogenicity and effectiveness. The provider may need to consider alternative vaccination strategies, including higher antigen dose vaccines, adjuvanted vaccines, avoidance of live vaccines, and careful timing of vaccination to optimize safety and effectiveness in immunocompromised populations. This thematic review discusses general principles regarding immunization of adults across the spectrum of immunocompromise, examines current guidelines and studies that support them, and outlines future research needs.

Author/s:

Whitaker, JA

Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged ≥65 Years: Updated Recommendations of the Advisory Committee on Immunization Practices

John Bayhi — Fri, 22 Nov 2019 15:07:10 +0000

Date Added:

November 22, 2019

Journal/Publication:

Morbidity and Mortality Weekly Report

Publisher:

Centers for Disease Control and Prevention

Publication Date:

November 22, 2019

Issue:

Volume:

Pages:

1069-1075

URL:

Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged ≥65 Years: Updated Recommendations of the Advisory Committee on Immunization Practices

Type:

Public Health Announcements

Format:

Article

DOI (1):

10.15585/mmwr.mm6846a5

Keywords

Pneumococcal Vaccines

vaccination

pneumonia

PMID (1):

31751323

MeSH

child

Adult

Humans

Heptavalent Pneumococcal Conjugate Vaccine

Cochlear Implants

Serogroup

Advisory Committees

clinical decision-making

long-term care

13-valent pneumococcal vaccine

Pneumococcal Vaccines

23-valent pneumococcal capsular polysaccharide vaccine

Pneumococcal Infections

Updated recommendations from the ACIP regarding pneumococcal vaccination of patients > 65 years of age. James W. Mold, MD, MPH

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Two pneumococcal vaccines are currently licensed for use in adults in the United States: a 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Pfizer, Inc.]) and a 23-valent pneumococcal polysaccharide vaccine (PPSV23 [Pneumovax 23, Merck and Co., Inc.]). In 2014, the Advisory Committee on Immunization Practices (ACIP)* recommended routine use of PCV13 in series with PPSV23 for all adults aged ≥65 years based on demonstrated PCV13 safety and efficacy against PCV13-type pneumonia among adults aged ≥65 years (1). At that time, ACIP recognized that there would be a need to reevaluate this recommendation because it was anticipated that PCV13 use in children would continue to reduce disease burden among adults through reduced carriage and transmission of vaccine serotypes from vaccinated children (i.e., PCV13 indirect effects). On June 26, 2019, after having reviewed the evidence accrued during the preceding 3 years (https://www.cdc.gov/vaccines/acip/recs/grade/PCV13.html), ACIP voted to remove the recommendation for routine PCV13 use among adults aged ≥65 years and to recommend administration of PCV13 based on shared clinical decision-making for adults aged ≥65 years who do not have an immunocompromising condition,† cerebrospinal fluid (CSF) leak, or cochlear implant, and who have not previously received PCV13. ACIP recognized that some adults aged ≥65 years are potentially at increased risk for exposure to PCV13 serotypes, such as persons residing in nursing homes or other long-term care facilities and persons residing in settings with low pediatric PCV13 uptake or traveling to settings with no pediatric PCV13 program, and might attain higher than average benefit from PCV13 vaccination. When patients and vaccine providers§ engage in shared clinical decision-making for PCV13 use to determine whether PCV13 is right for a particular person, considerations might include both the person's risk for exposure to PCV13 serotypes and their risk for developing pneumococcal disease as a result of underlying medical conditions. All adults aged ≥65 years should continue to receive 1 dose of PPSV23. If the decision is made to administer PCV13, it should be given at least 1 year before PPSV23. ACIP continues to recommend PCV13 in series with PPSV23 for adults aged ≥19 years with an immunocompromising condition, CSF leak, or cochlear implant (2).

Author/s:

Matanock, A, Lee, G, Gierke, R, Kobayashi, M, Leidner, A, Pilishvili, T

Population-level impact and herd effects following the introduction of human papillomavirus vaccination programmes: updated systematic review and meta-analysis

John Bayhi — Fri, 09 Aug 2019 19:52:40 +0000

Date Added:

August 9, 2019

Journal/Publication:

Lancet

Publisher:

Elsevier Ltd

Publication Date:

June 26, 2019

Issue:

10197

Volume:

394

Pages:

497-509

URL:

Population-level impact and herd effects following the introduction of human papillomavirus vaccination programmes: updated systematic review and meta-analysis

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1016/S0140-6736(19)30298-3

Keywords

human papillomavirus

hpv vaccine

vaccination

PMID (1):

31255301

MeSH

Papillomavirus Vaccines

Papillomavirus Infections

HPV vaccination works. Just do it! James W. Mold, MD, MPH

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BACKGROUND:

More than 10 years have elapsed since human papillomavirus (HPV) vaccination was implemented. We did a systematic review and meta-analysis of the population-level impact of vaccinating girls and women against human papillomavirus on HPV infections, anogenital wart diagnoses, and cervical intraepithelial neoplasia grade 2+ (CIN2+) to summarise the most recent evidence about the effectiveness of HPV vaccines in real-world settings and to quantify the impact of multiple age-cohort vaccination.

METHODS:

In this updated systematic review and meta-analysis, we used the same search strategy as in our previous paper. We searched MEDLINE and Embase for studies published between Feb 1, 2014, and Oct 11, 2018. Studies were eligible if they compared the frequency (prevalence or incidence) of at least one HPV-related endpoint (genital HPV infections, anogenital wart diagnoses, or histologically confirmed CIN2+) between pre-vaccination and post-vaccination periods among the general population and if they used the same population sources and recruitment methods before and after vaccination. Our primary assessment was the relative risk (RR) comparing the frequency (prevalence or incidence) of HPV-related endpoints between the pre-vaccination and post-vaccination periods. We stratified all analyses by sex, age, and years since introduction of HPV vaccination. We used random-effects models to estimate pooled relative risks.

FINDINGS:

We identified 1702 potentially eligible articles for this systematic review and meta-analysis, and included 65 articles in 14 high-income countries: 23 for HPV infection, 29 for anogenital warts, and 13 for CIN2+. After 5-8 years of vaccination, the prevalence of HPV 16 and 18 decreased significantly by 83% (RR 0·17, 95% CI 0·11-0·25) among girls aged 13-19 years, and decreased significantly by 66% (RR 0·34, 95% CI 0·23-0·49) among women aged 20-24 years. The prevalence of HPV 31, 33, and 45 decreased significantly by 54% (RR 0·46, 95% CI 0·33-0·66) among girls aged 13-19 years. Anogenital wart diagnoses decreased significantly by 67% (RR 0·33, 95% CI 0·24-0·46) among girls aged 15-19 years, decreased significantly by 54% (RR 0·46, 95% CI 0.36-0.60) among women aged 20-24 years, and decreased significantly by 31% (RR 0·69, 95% CI 0·53-0·89) among women aged 25-29 years. Among boys aged 15-19 years anogenital wart diagnoses decreased significantly by 48% (RR 0·52, 95% CI 0·37-0·75) and among men aged 20-24 years they decreased significantly by 32% (RR 0·68, 95% CI 0·47-0·98). After 5-9 years of vaccination, CIN2+ decreased significantly by 51% (RR 0·49, 95% CI 0·42-0·58) among screened girls aged 15-19 years and decreased significantly by 31% (RR 0·69, 95% CI 0·57-0·84) among women aged 20-24 years.

INTERPRETATION:

This updated systematic review and meta-analysis includes data from 60 million individuals and up to 8 years of post-vaccination follow-up. Our results show compelling evidence of the substantial impact of HPV vaccination programmes on HPV infections and CIN2+ among girls and women, and on anogenital warts diagnoses among girls, women, boys, and men. Additionally, programmes with multi-cohort vaccination and high vaccination coverage had a greater direct impact and herd effects.

FUNDING:

WHO, Canadian Institutes of Health Research, Fonds de recherche du Québec - Santé.

Author/s:

HPV Vaccination Impact Study Group, Benard, M, Perez, E, Brisson, N

ACIP Approves New Guidance on HPV, Pneumococcal Vaccines

Brian Desmarais — Wed, 10 Jul 2019 00:22:03 +0000

Date Added:

July 9, 2019

Journal/Publication:

American Academy of Family Physicians

Publication Date:

July 3, 2019

URL:

ACIP Approves New Guidance on HPV, Pneumococcal Vaccines

Type:

Public Health Announcements

Format:

Web Page

Keywords

MeSH

Neisseria meningitidis, Serogroup B

Pneumococcal Vaccines

centers for disease control and prevention (U.S.)

The Advisory Committee on Immunization Practices have updated their recommendations regarding HPV vaccine in adults 27-45 (shared decision-making), PCV 13 vaccine in adults 65 and older (shared decision-making), and Meningococcal B vaccine (booster dose after 1 – 2 years in immunocompromised children).

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July 03, 2019 03:21 pm Chris Crawford – During the June 26-27 meeting(www.cdc.gov) of the CDC's Advisory Committee on Immunization Practices, the group voted to update its recommendations for use of the nine-valent HPV and 13-valent pneumococcal conjugate vaccines.

AAFP liaison to the ACIP Pamela Rockwell, D.O., of Ann Arbor, Mich., told AAFP Newsother topics considered during the meeting included recommendations for a catch-up schedule for children and adolescents ages 2-18 who hadn't previously received hepatitis A vaccine, as well as guidance for serogroup B meningococcal vaccination boosters for those with special conditions/circumstances.

Author/s:

Crawford, C.

Grommets (ventilation tubes) for recurrent acute otitis media in children

Brian Desmarais — Thu, 23 May 2019 13:35:27 +0000

Date Added:

May 23, 2019

Journal/Publication:

The Cochrane Database of Systematic Reviews

Publication Date:

May 9, 2018

URL:

Grommets (ventilation tubes) for recurrent acute otitis media in children

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1002/14651858.CD012017.pub2

Keywords

MeSH

Middle Ear Ventilation

Otitis Media with Effusion

Odds Ratio

anti-bacterial agents

Tympanic Membrane Perforation

Antibiotic Prophylaxis

PE tube insertion in children with recurrent AOM may reduce the number of episodes of AOM but not by much. James W. Mold, MD, MPH

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BACKGROUND:

Acute otitis media (AOM) is one of the most common childhood illnesses. While many children experience sporadic AOM episodes, an important group suffer from recurrent AOM (rAOM), defined as three or more episodes in six months, or four or more in one year. In this subset of children AOM poses a true burden through frequent episodes of ear pain, general illness, sleepless nights and time lost from nursery or school. Grommets, also called ventilation or tympanostomy tubes, can be offered for rAOM.

OBJECTIVES:

To assess the benefits and harms of bilateral grommet insertion with or without concurrent adenoidectomy in children with rAOM.

SEARCH METHODS:

The Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; CENTRAL; MEDLINE; EMBASE; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 4 December 2017.

SELECTION CRITERIA:

Randomised controlled trials (RCTs) comparing bilateral grommet insertion with or without concurrent adenoidectomy and no ear surgery in children up to age 16 years with rAOM. We planned to apply two main scenarios: grommets as a single surgical intervention and grommets as concurrent treatment with adenoidectomy (i.e. children in both the intervention and comparator groups underwent adenoidectomy). The comparators included active monitoring, antibiotic prophylaxis and placebo medication.

DATA COLLECTION AND ANALYSIS:

We used the standard methodological procedures expected by Cochrane. Primary outcomes were: proportion of children who have no AOM recurrences at three to six months follow-up (intermediate-term) and persistent tympanic membrane perforation (significant adverse event). Secondary outcomes were: proportion of children who have no AOM recurrences at six to 12 months follow-up (long-term); total number of AOM recurrences, disease-specific and generic health-related quality of life, presence of middle ear effusion and other adverse events at short-term, intermediate-term and long-term follow-up. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.

MAIN RESULTS:

Five RCTs (805 children) with unclear or high risk of bias were included. All studies were conducted prior to the introduction of pneumococcal vaccination in the countries' national immunisation programmes. In none of the trials was adenoidectomy performed concurrently in both groups.Grommets versus active monitoringGrommets were more effective than active monitoring in terms of:- proportion of children who had no AOM recurrence at six months (one study, 95 children, 46% versus 5%; risk ratio (RR) 9.49, 95% confidence interval (CI) 2.38 to 37.80, number needed to treat to benefit (NNTB) 3; low-quality evidence);- proportion of children who had no AOM recurrence at 12 months (one study, 200 children, 48% versus 34%; RR 1.41, 95% CI 1.00 to 1.99, NNTB 8; low-quality evidence);- number of AOM recurrences at six months (one study, 95 children, mean number of AOM recurrences per child: 0.67 versus 2.17, mean difference (MD) -1.50, 95% CI -1.99 to -1.01; low-quality evidence);- number of AOM recurrences at 12 months (one study, 200 children, one-year AOM incidence rate: 1.15 versus 1.70, incidence rate difference -0.55, 95% -0.17 to -0.93; low-quality evidence).Children receiving grommets did not have better disease-specific health-related quality of life (Otitis Media-6 questionnaire) at four (one study, 85 children) or 12 months (one study, 81 children) than those managed by active monitoring (low-quality evidence).One study reported no persistent tympanic membrane perforations among 54 children receiving grommets (low-quality evidence).Grommets versus antibiotic prophylaxisIt is uncertain whether or not grommets are more effective than antibiotic prophylaxis in terms of:- proportion of children who had no AOM recurrence at six months (two studies, 96 children, 60% versus 35%; RR 1.68, 95% CI 1.07 to 2.65, I2 = 0%, fixed-effect model, NNTB 5; very low-quality evidence);- number of AOM recurrences at six months (one study, 43 children, mean number of AOM recurrences per child: 0.86 versus 1.38, MD -0.52, 95% CI -1.37 to 0.33; very low-quality evidence).Grommets versus placebo medicationGrommets were more effective than placebo medication in terms of:- proportion of children who had no AOM recurrence at six months (one study, 42 children, 55% versus 15%; RR 3.64, 95% CI 1.20 to 11.04, NNTB 3; very low-quality evidence);- number of AOM recurrences at six months (one study, 42 children, mean number of AOM recurrences per child: 0.86 versus 2.0, MD -1.14, 95% CI -2.06 to -0.22; very low-quality evidence).One study reported persistent tympanic membrane perforations in 3 of 76 children (4%) receiving grommets (low-quality evidence).Subgroup analysisThere were insufficient data to determine whether presence of middle ear effusion at randomisation, type of grommet or age modified the effectiveness of grommets.

AUTHORS' CONCLUSIONS:

Current evidence on the effectiveness of grommets in children with rAOM is limited to five RCTs with unclear or high risk of bias, which were conducted prior to the introduction of pneumococcal vaccination. Low to very low-quality evidence suggests that children receiving grommets are less likely to have AOM recurrences compared to those managed by active monitoring and placebo medication, but the magnitude of the effect is modest with around one fewer episode at six months and a less noticeable effect by 12 months. The low to very low quality of the evidence means that these numbers need to be interpreted with caution since the true effects may be substantially different. It is uncertain whether or not grommets are more effective than antibiotic prophylaxis. The risk of persistent tympanic membrane perforation after grommet insertion was low.Widespread use of pneumococcal vaccination has changed the bacteriology and epidemiology of AOM, and how this might impact the results of prior trials is unknown. New and high-quality RCTs of grommet insertion in children with rAOM are therefore needed. These trials should not only focus on the frequency of AOM recurrences, but also collect data on the severity of AOM episodes, antibiotic consumption and adverse effects of both surgery and antibiotics. This is particularly important since grommets may reduce the severity of AOM recurrences and allow for topical rather than oral antibiotic treatment.

Author/s:

A.G., Mick, P., Venekamp, R.P.