Impact of pneumococcal conjugate vaccines on otitis media: A review of measurement and interpretation challenges.

Acute otitis media (AOM) is among the most frequent childhood diseases and is caused by various bacterial and viral etiological agents. In this article, we provide an overview of published studies assessing the impact of higher-valent pneumococcal conjugate vaccines (PCVs) on AOM. In some instances, reports of PCV impact on complications of AOM have been included. While randomized controlled trials (RCTs) allow for the most precise assessment of vaccine efficacy against AOM, observational studies provide answers to questions regarding the public health value of these vaccines in real-life settings. We discuss the challenges that arise when measuring PCV impact on AOM in observational studies: the local variability of viral and bacterial etiology, differences in case ascertainment, care-seeking behavior, standards of care and diagnosis of AOM (e.g. use of incisions), as well as declining baseline AOM incidence that can already be in place before PCV introduction, and how these factors can impact the results and their interpretation.