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Study Protocol
Revised

Therapy of parapneumonic empyema in children: a protocol for a scoping review of the literature

[version 2; peer review: 2 approved]
PUBLISHED 03 Jun 2024
Author details Author details
OPEN PEER REVIEW
REVIEWER STATUS

Abstract

Background

Empyema (the presence of pus in the pleural space) is a severe complication of community-acquired pneumonia and significant cause of morbidity, but, fortunately, not mortality in children. Between 0.6 and 2% of pneumonias are complicated by empyema and the three main pathogens involved are Streptococcus pneumoniae, Staphylococcus aureus and group A Streptococcus 1,2,3,4. Optimal management in children, especially the choice of antibiotics, method of administration and duration of therapy, pleural dranage or surgery, are still a matter of debate and currently, lack of strong specific recommendations. This paper displays the study protocol for a scoping review that aims to summarize the available literature on the microbiological epidemiology, the medical and surgical treatment options, and the outcomes of pleural empyema in pediatric population.

Methods

Comprehensive research combining the terms pediatric (children aged 0 to 18 years) and pleural empyema will be performed on PubMed and SCOPUS to identify all eligible studies. At first, two reviewers will screen the abstract and then their full text to determine the articles that meet the inclusion criteria. This work will be carried out independently, everyone on a different Excel spreadsheet and each researcher will be blinded to the decision of the other researcher. When the process is completed, in case of discordance, any disagreement will be identified and resolved through discussion or with help of a third author.

Dissemination

The findings of this review will be published in a peer-reviewed journal.

Keywords

Parapneumonic empyema; complicated pneumonia; children

Revised Amendments from Version 1

We have performed the requested changes.
In particular we have:
- clarified further some inclusion and exclusion criteria
- clarified analyses according to microbiological results
- expanded outcomes and literature research 
- improved grammar structure as suggested by reviewer 1

See the authors' detailed response to the review by King-Pui Florence Chan
See the authors' detailed response to the review by Catherine A Byrnes

Introduction

Parapneumonic empyema is defined by the collection of pus on the pleural surfaces, and it represents one of the most common local complications of community-acquired pneumonia (CAP) in children.15 It has been estimated that parapneumonic effusions develop in about 1 in 100-150 children with CAP6,7 but they could be discovered in as many as 40% of hospitalised children with CAP.8

CAP, are caused mainly by Streptococcus pneumoniae9 and their incidence has shown fluctuations over time. In particular, a significant global reduction in pneumococcal disease and mortality rates has been reported after the introduction of heptavalent pneumococcal conjugate vaccine (PCV7), which covers serotypes 4, 6B, 9V, 14, 18C, 19F and 23F, into the standard childhood immunisation schedule.10 In the following years, however, in the USA an increase in pneumococcal empyema, related to serotypes not covered by PCV7, has been reported.11 After the replacement of the PCV7 with the PCV13, which covers also serotypes 1, 3, 5, 6A, 7F and 19 A, there has been a significant reduction in incidence and rate of hospitalisation for empyema.12 The introduction of PCV13 is particularly important in consideration of the strong correlation between parapneumonic empyema and serotype 1 of pneumococcus.13

Other bacteria seem to be less frequently pathogens of CAP. However, other possible bacterial pathogens of parapneumonic empyema are represented by group A Streptococcus and Staphylococcus aureus.13

Clinical presentation of parapneumonic empyema is similar to that of uncomplicated CAP. The presence of an empyema should be suspected in children with prolonged fever (more or equal to 7 days) and in those who do not improve after 48-72 hours of adequate antibiotic therapy.9,13 In physical examination, typically, parapneumonic empyema is characterized by decreased air entry breath and dullness to percussion.9

A clinical suspect of parapneumonic empyema should be confirmed performing a chest X-ray and/or pulmonary ultrasound. Ultrasound technique has a higher sensitivity than radiograph in determining extension and nature of fluid collection and it is very useful for monitoring children with empyema, considering that it does not expose to X-rays. Thoracic CT is not considered a first line exam in order to make diagnosis of empyema, but it should be performed when it is not possible to make a clear diagnosis or when there is a suspect of malignancies (i.e. Burkitt’s lymphoma).

All cases of parapneumonic empyema should be treated with empiric intravenous antibiotic therapy, covering Streptococcus pneumoniae, Streptococcus pyogenes and Staphylococcus aureus. However, in case of large effusion (> 2 cm) or compromission of respiratory function a chest drainage is essential.5,14 Chest drainage is generally performed under ultrasound guide and children should be under sedation/general anaesthesia.14 Intrapleural fibrinolytics (i.e. urokinase) are particularly useful in shortening hospitalisation in cases where drainage is slow, in consideration of thick or loculated fluid.5,14 Thoracic surgery should be taken in consideration in cases of failure of antibiotic therapy, chest drainage and fibrinolytics. However, guidelines are unclear about which surgical procedure is best and at which timing, as well duration of drainage or of antibiotic therapy, including optimal timing about oral shift and how these issues reflect on outcomes.

This scoping review aims to analyse the optimal antibiotic therapy, defining antibiotic molecule, route of administration and duration of antimicrobial therapy.

Review questions

Considering the importance of a mutual consensus in the clinical management of parapneumonic empyema in children, as documented in the available literature,15 the main review question will be: what is the available literature about the most appropriate antibiotic treatment for paediatric PE in terms of first-line agents choice, dose, route of administration and duration?

This review will also assess the following sub-questions:

  • 1. Which are the most frequently reported pathogens and what is their antibiotic susceptibility profile?

  • 2. Which outcomes and complication rates of PE are the most frequently reported in literature? Which are the most frequently reported treatments, both conservative or invasive, and which leads to improved outcomes and shorter length of stay?

Inclusion criteria

Participants

This review will include studies performed on children and adolescents (younger than 18 years) with a confirmed diagnosis of empyema, defined as the presence of pus within the pleural cavity. The diagnosis of empyema is established by the presence of pus, positive Gram's stain, or culture, or nucleic-acid amplification tests, in the pleural fluid. We will only include studies that have documented at leaast one of the following: the microbiological aetiologies, performed antimicrobial and surgical therapies, as well outcomes (at least at time of discharge). Only studies in English will be included. Empyema due to tuberculosis will be excluded.

Concept

The main concept of this review will be empyema in all its aspects, with a particular focus on treatment options.

Context

Considering the severity of the disease, we will not expect to find articles involving patients not hospitalized so we will include only inpatients.

Type of sources

This review will include both randomized controlled trials and non-randomized controlled trials. All the types of observational studies, prospective and retrospective (including case-control, cohort and cross-sectional studies, small case series or single case reports) will be included.

Methods

Search strategy

The search will be performed by one reviewer. We started our research in April 2023 in the following bibliographic databases: PubMed and SCOPUS. There will be date restrictions: we will search from the 1st of January 2000 to 31st of March 2023. Only articles written in English will be included. The search strategy will include a combination of the following word and their synonymous: “pediatric”, “empyema”, “pleural effusion” and “treatment”. The search strategy for PubMed is available in the extended data section of this protocol; the terms used for this search will be adapted for use with other bibliographic database.

Study selection

After the search, the studies will be exported to Rayyan. A first screen to exclude duplicates will be performed by one author.

Titles and/or abstracts of studies retrieved using the search strategy will be screened independently by two reviewers to identify studies that could be inserted reviewed. Full texts of potentially eligible studies will be retrieved and independently assessed for eligibility by two reviewers. Each researcher will be blinded to the decision of the other researcher. Any disagreement between them over the eligibility of studies will be resolved through discussion and, in case of further disagreement, by discussion with a third reviewer.

All the studies that will not meet the inclusion criteria will be excluded and a table with the reason why those studies were excluded will be inserted in the final manuscript.

The results of the search will be reported in the PRISMA flow diagram.

Data extraction

Two review authors will extract data independently, both on a different Excel spreadsheet. Each researcher will be blinded to the decision of the other researcher. When the process will be completed, in case of discordance, any disagreement will be identified and resolved through discussion (with a third author if necessary).

An Excel file will be used to store data. When available, extracted information will include:

  • 1. study general features: title, author, year of publication, type of study, number of patients included in the study, geographical area where the study has been performed

  • 2. participant general features: sample size of each group, nationality, age, socio-economic status, comorbidities

  • 3. clinical manifestation of the condition: fever (including days), cough with mucus, dyspnoea, chest pain and others.

  • 4. main imaging findings: type of lung involvement at chest X-Ray and/or CT scan, type of CNS involvement at CT scan or MRI, type of skin involvement evaluated by ultrasound or CT scan or MRI, heart (US or CT or MRI)

  • 5. characteristics of eventual antimicrobial treatments performed during the empyema (length of therapy, when this has been started and which antibiotic was used)

  • 6. adjunctive treatments performed and length of therapy during the empyema (e.g., steroids or other immunomodulatory medications)

  • 7. surgical treatments performed and length of therapy during the empyema (e.g., drainage or thoracoscopy or surgical resection)

  • 8. outcomes (admission to intensive care, death, survival; survival with sequelae; type of sequelae)

Data analysis and presentation

To report our findings, we will follow Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) Checklist.

We will produce a narrative synthesis of the findings from the studies included in the review describing the results we have obtained and providing our opinion on their interpretation. A particular focus with a narrative synthesis will be performed for antimicrobial and surgical therapy characteristics in terms of frequency of antibiotic choice, efficacy, and duration of therapy.

We will also use tables and charts to summarize both study characteristics and the most important clinical, diagnostics, treatments, and outcomes data.

More specifically, we will summarize our findings using different tables. The first one will include the characteristics of included studies (number of studies, study design, year of publication, characteristics of the study populations and countries where studies were conducted) and the participant general features. Then we will provide different tables or figures summarizing main data about clinical presentation, imaging characteristics, treatments performed, outcomes and predictors of empyema. We will also evaluate outcomes and treatment approaches according to the different aetiologies.

This way we hope we will be able to provide a useful document containing what is currently known of pediatric empyema with the aim of informing clinicians about the general characteristics of these conditions, focusing on risk factors and early clinical features, and guide future research projects to fill current gaps.

Study status

Protocol has been submitted and researched launched on the different datasets. Abstract screening will start after protocol submission.

Patient and public involvement

There was no direct patient and public involvement in this review. However, the key questions that led us implementing this research project were inspired by public discussions started by family associations in the media, highlighting the importance of better comprehension of how empyema can be recognized earlier in the disease course (before clinical conditions deteriorates and cannot be controlled anymore), or empyema may also be prevented if this complication is a consequence of a previous unrecognized and untreated lung infection.

Strengths and limitations of this study

  • A scoping review can represent the best way to report on the types of evidence that are published in a certain field and our paper will provide an overview of empyema, focusing on predictors of positive outcomes.

  • A scoping review can represent the best way to examine this field to guide future research on this topic.

  • To report our findings, we will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) Checklist to ensure methodological strength to our paper.

  • Only two databases were screened, and only English paper will be considered limiting the number of papers that will be included.

  • No critical appraisal neither risk of bias of the included studies will be performed, considering the exploratory role of this paper.

Comments on this article Comments (1)

Version 2
VERSION 2 PUBLISHED 03 Jun 2024
Revised
  • Reader Comment 21 Jun 2024
    Biju S Punnooreth null, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, India
    21 Jun 2024
    Reader Comment
    This protocol highlights the need for review on the topic, However it is not specified about whether you will be including articles discussed about COVID-19 related empyema. Or are you ... Continue reading
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CITE
how to cite this article
Buonsenso D, Cusenza F, Passadore L et al. Therapy of parapneumonic empyema in children: a protocol for a scoping review of the literature [version 2; peer review: 2 approved]. F1000Research 2024, 12:1527 (https://doi.org/10.12688/f1000research.135295.2)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Open Peer Review

Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 2
VERSION 2
PUBLISHED 03 Jun 2024
Revised
Views
3
Cite
Reviewer Report 01 Aug 2024
Catherine A Byrnes, Auckland District Health Board, Starship Children's Health, Auckland, New Zealand 
Approved
VIEWS 3
Thanks - I think the changes are appropriate. 

I think it looks good for indexing.

I have a couple of minor English edits to make to read correctly (but if you make those changes ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Byrnes CA. Reviewer Report For: Therapy of parapneumonic empyema in children: a protocol for a scoping review of the literature [version 2; peer review: 2 approved]. F1000Research 2024, 12:1527 (https://doi.org/10.5256/f1000research.167272.r285922)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Views
3
Cite
Reviewer Report 27 Jun 2024
King-Pui Florence Chan, University of Hong Kong, Queen Mary Hospital,, Hong Kong, Hong Kong 
Approved
VIEWS 3
Thank you for the amendment. The protocol ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Chan KPF. Reviewer Report For: Therapy of parapneumonic empyema in children: a protocol for a scoping review of the literature [version 2; peer review: 2 approved]. F1000Research 2024, 12:1527 (https://doi.org/10.5256/f1000research.167272.r285923)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Version 1
VERSION 1
PUBLISHED 28 Nov 2023
Views
5
Cite
Reviewer Report 28 May 2024
King-Pui Florence Chan, University of Hong Kong, Queen Mary Hospital,, Hong Kong, Hong Kong 
Approved with Reservations
VIEWS 5
The study protocol aims to provide a literature review on children with pleural empyema. The protocol can be improved by further clarification.

1. In the method part, I am not aware of how the bacterial results is ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Chan KPF. Reviewer Report For: Therapy of parapneumonic empyema in children: a protocol for a scoping review of the literature [version 2; peer review: 2 approved]. F1000Research 2024, 12:1527 (https://doi.org/10.5256/f1000research.148406.r272217)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 21 Jun 2024
    danilo buonsenso, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy, Rome, Italy
    21 Jun 2024
    Author Response
    thank you, I have responded to your main comments
    Competing Interests: No competing interests were disclosed.
COMMENTS ON THIS REPORT
  • Author Response 21 Jun 2024
    danilo buonsenso, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy, Rome, Italy
    21 Jun 2024
    Author Response
    thank you, I have responded to your main comments
    Competing Interests: No competing interests were disclosed.
Views
7
Cite
Reviewer Report 15 May 2024
Catherine A Byrnes, Auckland District Health Board, Starship Children's Health, Auckland, New Zealand 
Approved with Reservations
VIEWS 7
Generally this is a good proposal – responding to queries and questions generated from patients and using Prism as the backbone which is good.
  1. Not much is mentioned regarding chest drains – nil in abstract, not
... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Byrnes CA. Reviewer Report For: Therapy of parapneumonic empyema in children: a protocol for a scoping review of the literature [version 2; peer review: 2 approved]. F1000Research 2024, 12:1527 (https://doi.org/10.5256/f1000research.148406.r245793)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 21 Jun 2024
    danilo buonsenso, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy, Rome, Italy
    21 Jun 2024
    Author Response
    thank you very much, we changed as you suggested
    Competing Interests: nothing
COMMENTS ON THIS REPORT
  • Author Response 21 Jun 2024
    danilo buonsenso, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy, Rome, Italy
    21 Jun 2024
    Author Response
    thank you very much, we changed as you suggested
    Competing Interests: nothing

Comments on this article Comments (1)

Version 2
VERSION 2 PUBLISHED 03 Jun 2024
Revised
  • Reader Comment 21 Jun 2024
    Biju S Punnooreth null, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, India
    21 Jun 2024
    Reader Comment
    This protocol highlights the need for review on the topic, However it is not specified about whether you will be including articles discussed about COVID-19 related empyema. Or are you ... Continue reading
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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