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Postoperative controls of ventilation tubes in children by general practitioner or otolaryngologist? Study protocol
Bjarne Austad1,2, Ann Helen Nilsen3,4, Anne-Sofie Helvik5
1Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. bjarne.austad@ntnu.no.
Insights
General practitioners (GPs) can safely manage children’s ventilation tube follow-up care. This study compares GP care to specialist care, aiming to establish evidence-based guidelines for postoperative otitis media with effusion treatment.
Area of Science:
- Pediatric Otolaryngology
- General Practice
- Evidence-Based Medicine
Background:
- Otitis media with effusion is a leading cause of acquired hearing loss in children.
- Ventilation tube surgery is common for managing persistent effusion, improving hearing, and quality of life.
- Current follow-up guidelines lack evidence regarding the expertise required for postoperative care.
Purpose of the Study:
- To evaluate the safety and sufficiency of general practitioners (GPs) performing postoperative controls for ventilation tubes.
- To compare GP-led care with otolaryngologist-led care after ventilation tube surgery.
Main Methods:
- A multicenter, randomized non-inferiority study (ConVenTu) involving 400 children aged 3-10 years.
- Participants are randomized to receive postoperative care from either an otolaryngologist or their GP.
- Primary endpoint: comparison of pure tone average hearing thresholds after two years.
Main Results:
- This protocol outlines the first randomized non-inferiority study comparing GP and otolaryngologist postoperative care for ventilation tubes.
- The study will provide data on hearing thresholds, middle ear function, complications, and quality of life.
Conclusions:
- Results will inform the development of evidence-based clinical practice guidelines for postoperative ventilation tube management.
- This research aims to determine if GPs can provide safe and sufficient follow-up care, potentially optimizing healthcare resource utilization.
Background:
Otitis media with effusion is the major cause of acquired hearing problems in children. Some of the affected children need surgery with ventilation tubes in the tympanic membrane to reduce ear complaints and to improve hearing, middle ear function, and health-related quality of life. This is one of the most common ambulatory surgeries performed on children. Postoperative controls are needed to assess that the tubes are functional, to evaluate whether hearing loss has been improved, and to handle potential complications. The follow-up may continue for years and are usually done by otolaryngologists. Nevertheless, there exist no evidence-based guidelines concerning the level of expertise needed for postoperative controls of the ventilation tubes. The aim of this protocol is to describe the ConVenTu study that evaluates whether postoperative controls performed by general practitioners (GPs) represent a safe and sufficient alternative to controls performed by otolaryngologists.
Methods/Design:
Multicenter randomized non-inferiority study conducted in clinical settings in seven hospitals located in Norway. Discharged children with ventilation tubes, aged 3-10 years, are allocated randomly to receive postoperative controls by either an otolaryngologist at the hospital where they had ventilation tube surgery or their regular GP. Study participants are enrolled consecutively until 200 patients are included in each group. Two years after surgery, we will compare the pure tone average of hearing thresholds (primary endpoint) and middle ear function, complication rate, health-related quality of life and the parents' evaluations of the postoperative care (secondary endpoints).
Discussion:
This protocol describes the first randomized non-inferiority study of GPs performing postoperative controls after surgery with ventilation tubes. Results from this study may be utilized for deriving evidence-based clinical practice guidelines of the level of postoperative controls after ventilation tube surgery which is safe and sufficient.
Trial Registration:
ClinicalTrials.gov NCT02831985 . Registered on 13 July 2016.
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