Serotypic distribution and antimicrobial resistance of Streptococcus pneumoniae in Chinese children under 5 years after the introduction of the 13-valent conjugate pneumococcal vaccine: protocol for a scoping review

Inclusion criteria

All types of studies are eligible for inclusion in our review if they meet all 5 of the following criteria: (1) Analyze serotype distribution or antimicrobial resistance to S. pneumoniae in China; (2) contain information on the impact of PCV13 in China; (3) include only subjects less than 5 years of age; (4) be written in English or Chinese; and (5) be published between November 2016 and February 2020.

Two investigators will independently evaluate the titles and abstracts of all articles according to the inclusion criteria. Any disagreement will be resolved through discussion among team members, and if there is difficulty related to the selection of studies, the criteria will be refined.

Information sources

The study will begin in March 2020 and will include searches of PubMed, the China National Knowledge Infrastructure (CNKI), Wanfang Med Online, the WHO database, and the China Antimicrobial surveillance Network (CHINET).

PubMed is the largest database of medical information in the world. Created in 1946 by the National Library of Medicine, it includes the MEDLINE database, which contains information from more than 24 million articles published in 5,600 journals in 30 languages.

CNKI, as the largest, most-used online academic library in China, is a key national information construction project under the lead of Tsinghua University. It is the most comprehensive repository of knowledge in China, with more than 16 million website visits each day. In 2019, the website recorded 2.3 billion full-text downloads.

Wanfang Med Online aims to become a type of bridge that connects medical professionals and researchers in China with medical professionals and researchers around the world. At present, the English version includes about 200 selected Chinese medical journals including the top 115 medical journals published by the Chinese Medical Association, 1 Science Citation Index (SCI) journal, 7 Science Citation Index Expanded (SCIE) journals, and 60 Medline journals.

Search

The search strategy will be based on a combination of three elements: the condition of interest, the specified intervention, and the geographical region (Figure 1). The use of "OR" and "AND" to combine key words is shown in Table 2.

Figure 1. Summary of search strategy.

Study records

Data management. Retrieved records will be automatically or manually exported into EndNote.

Selection process. The search and selection process will be documented in a PRISMA flowchart⁹. Screening and selection will be done in duplicate by two members of the review team. Any discrepancies discovered during screening of full-text papers will be discussed with the principal investigator.

Data collection process. Two investigators will independently extract data from the studies that meet the inclusion criteria. Any disagreement will be resolved through discussion, and if they do not agree, the principal investigator will arbitrate. If data are missing or not sufficiently described in the studies, we will contact the corresponding author to obtain the missing information.

Data items. The information technology department will develop two tables for organizing the data: a table that itemizes serotype, and a table that lists antimicrobial resistance to pneumococci. The tables will contain the elements listed in Table 3.

Outcomes and prioritization

Our review will focus on the scope of the available literature about the serotype distribution of and antibiotic resistance to S. pneumoniae, and the potential impact of PCV13 in China. We do not foresee outcome prioritization, but the approach will be descriptive.

Risk of bias in individual studies

The risk of bias will be determined independently by two study team members. For nonrandomized studies, we will use the ROBINS-I tool¹⁰, and for randomized trials, or interventions, we plan to use Cochrane Collaboration's risk-of-bias assessment tool¹¹.

Data synthesis

A PRISMA flow chart and the methodological process will be described in detail for transparency. It will indicate the evidence identified and whether it was selected for inclusion in the review. If a study is excluded, the reasons will be provided.

The data will be summarized in the form of a figure, diagram, or table. A narrative summary of the findings will also be included. The strategy for synthesizing the data involves the use of analytical methods and will perform a descriptive synthesis of the data to map the distribution of serotypes and antimicrobial resistance of pneumococci in children under 5 years of age in China after the introduction of PCV13.

Review team and roles

The review team is presented in Table 4.

Study status

This review is a part of ongoing research in China on the interchangeability of PCV13 with the Cuban vaccine PCV7-TT. When we complete this scoping review, we will consider conducting a systematic review, and we intend to publish the results in an international journal. While preparing the present protocol, we performed preliminary searches to get an idea of the size of the available literature.

Ethics

Because the scoping review methodology consists of reviewing and synthesizing the data already published, this part of the study is not subject to ethical approval.

Study strengths