Related Experiment Video
Updated: Jul 8, 2025
Assessment of the Efficacy of An Osteopathic Treatment in Infants with Biomechanical Impairments to Suckling
Published on: February 5, 2019
Outcome measures for use in trials of paediatric otorrhoea: A systematic review
Elliot Heward1, James Dempsey2, John Molloy1
1Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, UK; Royal Manchester Children's Hospital, Manchester University Hospitals NHS Foundation Trust, UK.
Insights
This review found that "otorrhoea cessation" is the primary outcome in most studies of paediatric ear infections. Future research should standardize this measure for better comparison of treatments for children with ear discharge.
Area of Science:
- Otolaryngology
- Pediatric Medicine
- Evidence-Based Medicine
Background:
- Paediatric otorrhoea (PO) involves middle ear infections with tympanic membrane perforation and ear discharge in children.
- Prolonged PO can lead to hearing loss and developmental delays.
- Current management is variable due to a weak evidence base, highlighting the need for standardized outcome reporting.
Approach:
- A systematic review was conducted following PRISMA guidelines, searching EMBASE, MEDLINE, and Cochrane databases from January 1995 to May 2023.
- Included randomized controlled trials and study protocols for children and young people (CYP) with PO.
- Risk of bias was assessed using Cochrane's tool.
Key Points:
- Six studies were included from 377 identified papers.
- The primary outcome in five studies was otorrhoea cessation, measured by time to cessation and proportion recovered.
- Two applicable measurement instruments were identified: Otitis Media-6 Questionnaire and the Institute for Medical Technology Assessment Productivity Cost Questionnaire.
Conclusions:
- Standardizing "time to cessation of otorrhoea" as the primary outcome in future studies is recommended for homogeneity and comparison.
- Further research is necessary to confirm if this outcome is most meaningful to children and caregivers.
Introduction:
Paediatric otorrhoea (PO) describes a middle ear infection that results in a perforation of the tympanic membrane and ear discharge, in children and young people (CYP). Prolonged infection may be associated with hearing loss and developmental delay. The current management of paediatric otorrhoea is variable, including non-invasive treatments (conservative, oral antibiotics, topical antibiotics) and surgery, reflecting the lack of a sufficiently strong evidence base. Outcome reporting is fundamental to producing reliable and meaningful evidence to inform best practice.
Objectives:
Primary objective: to determine which outcome measures are currently used to evaluate treatment success in studies of non-surgical treatments for paediatric otorrhoea.
Secondary Objectives:
to identify outcome measurement instruments used in the literature and assess their applicability for use in clinical trials of PO.
Methods:
This systematic review was registered with PROSPERO (CRD42023407976). Database searches of EMBASE, MEDLINE and Cochrane was performed on June 6, 2023, covering from Jan 1995 to May 2023. Randomised controlled trials or study protocols involving CYP with PO were included following PRISMA guidelines. Risk of bias was assessed with Cochrane's tool.
Results:
Of the 377 papers identified, six were included in the systematic review. The primary outcome of five of the studies related to otorrhoea cessation; both time to cessation and proportion recovered at various time points were used as measures. Two measurement instruments were identified: Otitis Media-6 Questionnaire and the Institute for Medical Technology Assessment Productivity Cost Questionnaire. Both were shown to be applicable measurement instruments when used in clinical trials of PO.
Conclusions:
To promote homogeneity and facilitate meaningful comparison and combination of studies, we propose that time to cessation of otorrhoea from onset of otorrhoea should be used as the primary outcome in future studies. Further research is needed to establish if this is the most important outcome to children and their caregivers.
More Related Videos
09:07Author Spotlight: Advancing Endoscopic Ossiculoplasty – Techniques, Innovations, and Practical Guidance for Clinical Integration
Published on: January 26, 2024
07:06Endaural Endoscopic Atticoantrotomy Retrograde Mastoidectomy using a Constant Suction Bone-drilling Technique
Published on: May 23, 2021
Related Concept Videos
01:16Clinical Trials
There are four phases in a clinical trial. A phase one...
01:25Suctioning the Oropharyngeal Airway
After assembling the equipment, the nurse should practice hand hygiene and don appropriate PPE according to infection control guidelines to avoid the...