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Samenvatting
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Sinds januari 2015 voeren wij een pragmatische, cluster-gerandomiseerde studie uit, waarin de effectiviteit van een meervoudige educatieve interventie, gericht op het optimaliseren van pijnbestrijding bij kinderen met OMA, wordt vergeleken met gebruikelijke zorg. De interventie bestaat uit een onderwijsmodule voor de huisarts bestaande uit een e-learning en praktijkvisite door de arts-onderzoeker, een interactieve informatiefolder over pijnstilling voor ouders en het voorschrijven van pijnstillers conform de huidige richtlijnen. De studie onderzoekt zowel de klinische uitkomsten, zoals ernst en duur van klachten als oorpijn en koorts, aantal vervolgconsulten en antibioticagebruik, alsook de kosteneffectiviteit.

Resultaten
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In totaal nemen 37 huisartsenpraktijken (90 huisartsen) deel aan de studie. Per eind februari 2018 bedraagt het aantal deelnemende kinderen 216. We verwachten de inclusieperiode per mei 2018 te kunnen beëindigen. In deze fase van het onderzoek zijn er nog geen resultaten, deze worden eind 2018 verwacht.

Samenvatting van de aanvraag

Samenvatting
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Background and rationale:

Acute otitis media (AOM) is one of the most common illnesses, the second most frequent reason to visit a general practitioner (GP) and a prime indication for antibiotic prescription in children. Parents of children with AOM often seek medical support to ease their child’s symptoms, typically pain and fever, and to shorten the illness duration. Randomized trials have shown that antibiotics are of limited benefit in children with AOM, except for those under two years of age with bilateral AOM, or for those presenting with acute otorrhea and AOM. Therefore, optimal pain management is the cornerstone of treatment of children suffering from AOM to achieve symptom relief.

Notwithstanding the importance of optimal analgesic treatment in children with AOM, the available evidence shows that current pain management is far from optimal and not according the prevailing guidelines that advice the use of continuous painmedication and not only on demand.

Suboptimal analgesic management may lead to unnecessary pain and discomfort for the child and sleepless nights and loss of days of work for their parents. Moreover, it may contribute substantially to GP re-consultations and (delayed) antibiotic prescriptions because of persisting AOM symptoms. Although there is consensus that pain management should improve, studies to how and to what extent this can be achieved are lacking. We propose a cluster-randomised controlled trial (with the primary care practice as the unit of randomisation) to assess whether explicit advice from the GP to the parents concerning optimal pain management and actual prescribing of analgesia in children with AOM reduces pain and is cost-effective.

 

Research questions:

1. What is effect, in terms of pain relief,of explicit GP advice (and prescription) to parents on optimal pain management (paracetamol in a maximum dose with non-steroidal anti-inflammatory drugs (NSAID) in a maximum dose as add on in case of insufficient effect of paracetamol alone) compared to “usual care” in children aged 6 months to 10 years diagnosed with AOM

2. What is the cost-effectiveness of this optimal pain management in terms of less re-consultations, less secondary antibiotic prescriptions, less loss of work for the parents?

 

Design and setting

Pragmatic cluster-randomised controlled trial among children with AOM diagnosed in primary care with the primary care practice as the unit of randomisation,The follow-up time is 4 weeks.

 

Study population

Inclusion criteria: children aged 6 months to 10 years with a GP-diagnosed AOM. Exclusion criteria: ventilation tubes in place, Down syndrome, craniofacial malformations, known immunodeficiencies, renal failure/insufficiency.

 

Randomisation and interventions:

Participating general practices will be randomised to either the intervention arm (i.e. they will be trained to provide optimal pain management advice to parents of children with AOM (including a prescription and parent leaflets and information brochures regarding the maximum dose of paracetamol based on the child’s age, and prescription of NSAIDs) or to the “usual care” arm. Normal care consists of pain management according to normal daily practice

 

Outcome measures:

Primary outcome: the mean pain score during the first three days after the visit to the GP.

Secondary outcomes: number of days and severity of pain, number of days with fever, GP consultation rate, antibiotic prescription rate, drug side effects, health-related quality of life (HRQoL) of the child and its parents, costs (based on e.g. health care costs, absence from school or (for the parents) work).

 

Follow-up measurements

Parents will keep a daily diary of ear related symptoms (including ear pain scores), fever, healthcare consultations, absentiesm from school or child care center or work (for the parents) and treatments of their child during 4 weeks. Parents will be asked to complete a questionnaire on how they think about painmedication and how they perceived the information of the GP. At baseline and at 4 weeks, parents will complete HRQoL questionnaires and a questionnaire on labour and productivity. The number of re-consultations and (delayed) antibiotic prescriptions because of AOM will be extracted from the child’s medical records of the participating general practices.

 

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