Pain Intensity Monitoring in Paediatric Otitis Media

PIMPOM study is an acronym for ‘Pain Intensity Monitoring in Paediatric Otitis Media’ study: a primary care-based intervention study to optimise analgesic use in children with acute middle ear infections.

On this website, you will find information on the objective and contents of the PIM-POM study, as well as study materials used

General uitklapper, klik om te openen

The PIM-POM study is a pragmatic, cluster randomised controlled trial to assess the clinical and cost-effectiveness of a primary-care based multifaceted educational intervention aimed at optimising pain management compared with ‘usual care’ in children with acute otitis media (AOM).

The intervention consists of a blended GP educational programme (internet-based and face-to-face training) aimed at discussing pain management proactively with parents using an interactive parent information leaflet, and prescribing both paracetamol and ibuprofen according to prevailing Dutch guidelines.

The study investigates whether optimised analgesia through a GP-targeted multifaceted intervention reduces the intensity and duration of earache, fever, antibiotics prescriptions, reconsultation rates and AOM-related healthcare costs (e.g. absence from work).

Background 

Analgesics are essential in the management of childhood AOM. Optimal use of analgesics provides symptom relief and potentially reduces reconsultations, antibiotic prescribing, and healthcare costs. Current AOM practice guidelines emphasise the importance of providing analgesics to all children with AOM in an age-appropriate dose, in addition to prescribing antibiotics for certain children. _1,2

In daily practice, earache management is given little attention during the medical consultation _3-6 and routine antibiotic prescribing is still commonplace._3,7,8 Key factors driving general practitioners’ (GPs) management decisions include both clinician’s and parental concerns about young children’s vulnerability and parental pressure for antibiotic prescriptions. Parents still deem antibiotics the proper treatment for AOM, and analgesics alone insufficient._9-11

Multifaceted interventions addressing these concerns from both the perspectives of the GP and parents have proven effective in changing clinical practice _12,13. GPs highly value this type of intervention.₁₄ We therefore developed a primary care-based multifaceted intervention combining an online training module with a face-to-face study visit and a parent information leaflet to optimise pain management in children with AOM.

Documents uitklapper, klik om te openen

• Patient information letter for intervention group [PDF, in Dutch]
• Patient information letter for control group [PDF, in Dutch]
• Parental information leaflet [PDF, in Dutch]
• Parental information leaflet [PDF, in English]

References uitklapper, klik om te openen

1. Damoiseaux RAMJ, Venekamp RP, Eekhof JAH, Bennebroek Gravenhorst FM, Schoch AG, Wittenberg J, et al. [NHG-standaard Otitis media acuta bij kinderen]. Huisarts Wet 2014;57(12):648. Available through: https://www.nhg.org/standaarden/volledig/nhg-standaard-otitis-media-acuta-bij-kinderen
2. Lieberthal AS, Carroll AE, Chonmaitree T, Ganiats TG, Hoberman A, Tunkel DE, et al. The diagnosis and management of acute otitis media. Pediatrics 2013;131(3):e964-99.
3. Coco A, Vernacchio L, Horst M, Anderson A. Management of Acute Otitis Media After Publication of the 2004 AAP and AAFP Clinical Practice Guideline. Pediatrics 2010;125(2):214–20.
4. Forrest CB, Fiks AG, Bailey LC, Localio R, Grundmeier RW, Alessandrini AE. Improving Adherence to Otitis Media Guidelines With Clinical Decision Support and Physician Feedback. Pediatrics 2013;131:e1071-81.
5. Pulkki J, Huikko S, Rautakorpi U-M, Honkanen P, Klaukka T, Mäkelä M, et al. Management of pain in acute otitis media in Finnish primary care. Scand J Infect Dis 2006;38(4):265–7.
6. Tähtinen PA, Boonacker CWB, Rovers MM, Schilder AGM, Huovinen P, Ruohola A, et al. Parental experiences and attitudes regarding the management of acute otitis media – a comparative questionnaire between Finland and the Netherlands. Fam Pract 2009;26:488-92
7. Thompson PL, Gilbert LE, Long PF, Saxena S, Sharland M, Wong ICK. Has UK guidance affected general practitioner antibiotic prescribing for otitis media in children? J Public Health 2008;30(4):479–86.
8. Tyrstrup M, Beckman A, Mölstad S, Engström S, Lannering C, Hedin K, et al. Reduction in antibiotic prescribing for respiratory tract infections in Swedish primary care- a retrospective study of electronic patient records. BMC Infect Dis 2016;16:709.
9. Cabral C, Lucas PJ, Ingram J, Hay AD, Horwoord J. “It’s safer to…” parent consulting and clinician antibiotic prescribing decisions for children with respiratory tract infections: an analysis across four qualitative studies. Soc Science Med 2015;136-137:156-64.
10. Lucas PJ, Cabral C, Hay AD, Horwood J. A systematic review of parent and clinician views and perceptions that influence prescribing decisions in relation to acute childhood infections in primary care. Scand J Prim Health Care 2015;33(1):11-20.
11. Hansen MP, Howlett J, Del Mar C, Hoffmann TC. Parents’ beliefs and knowledge about the management of acute otitis media: a qualitative study. BMC Family Practice 2015;16(1):82. doi: 10.1186/s12875-015-0297-7
12. Baker R, Camosso-Stefinovic J, Gillies C, et al. Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2014;3:CD005470. doi: 10.1002/14651858.CD005470.pub2
13. Butler CC, Simpson SA, Evans J, Moore L. Effectiveness of multifaceted educational programme to reduce antibiotic dispensing in primary care : practice based randomised controlled trial. BMJ 2012;344:d8173.
14. Tonkin-crine S, Yardley L, Coenen S, Fernandez-vandellos P, Krawczyk J, Touboul P, et al. Strategies to promote prudent antibiotic use: Exploring the views of professionals who develop and implement guidelines and interventions. Fam Pract 2013;30(1):88–95.

Sponsor uitklapper, klik om te openen

The PIM-POM study is supported by a grant from the Netherlands Organisation for Health Research and Development (ZonMw) – HGOG subprogramme project number 839110005): optimising pain management in children with acute otitis media

ZonMw funds healthcare research commissioned by the Dutch Ministry of Health (VWS) and the Dutch Organisation for Scientific Research (NWO).  More information is available on the zonMw website

Trial registration uitklapper, klik om te openen

The trial has been prospectively registered (date of registration: 19 December 2014) in the Netherlands Trial Register, identifier NTR4920.

Ethical considerations uitklapper, klik om te openen

The trial is conducted according to the principles of the Declaration of Helsinki (10th version, October 2013)₁ and the Dutch Conduct Code Health Research (Gedragscode Gezondheidsonderzoek “Goed Gedrag”).₂

The use of paracetamol and ibuprofen in children has been proven safe in children; both safety and tolerability of paracetamol are equal to placebo₃, and the risk-profile of ibuprofen is similar to paracetamol.₄

The Medical Ethics Review Committee of the University Medical Center Utrecht, the Netherlands, reviewed the study protocol (protocol WAG/om/14/021633) and confirmed that an official approval was not required, since the Medical Research Involving Human Subjects Act (WMO) does not apply to our trial, as participation in the study does not add to the risks inherent to the condition (AOM) and its management in Dutch primary care. Although monitoring is not strictly necessary for studies to which the WMO does not apply, we have our study monitored by an independent data monitor to ensure quality in trial execution.

References:

1. World Medical Association. WMA Declaration of Helsinki – ethical principles for medical research involving human subjects. Fortaleza, Brazil: 2013.
2. Stichting Federatie van Medisch Wetenschappelijke Vereniging (Dutch Federation of Biomedical Science Associations). Gedragscode Gezondheidsonderzoek (Dutch Conduct Code for Health Research). Rotterdam, the Netherlands 
3. Southey ER, Soares-Weiser K, Kleijnen J. Systematic review and meta-analysis of the clinical safety and tolerability of ibuprofen compared with paracetamol in paediatric pain and fever. Curr Med Res Opin 2009;25(9):2207–22.
4. Pierce CA, Voss B. Efficacy and safety of ibuprofen and acetaminophen in children and adults: a meta-analysis and qualitative review. Ann Pharmacother 2010;44(3):489–506.

Publications & presentations uitklapper, klik om te openen

Publications

Van Uum RT, Venekamp RP, Schilder AGM, et al. Pain management in acute otitis media: a qualitative study of parents' views and expectations. BMC Fam Pract 2019;20(1):18

van Uum RT, Sjoukes A, Venekamp RP, et al. Pain management in acute otitis media: a qualitative study exploring GPs’ views and expectations parallel to a trial of an educational intervention. BJGP Open 2018;2(4): bjgpopen18X101620

van Uum RT, Venekamp RP, Sjoukes A, et al. Optimising pain management in children with acute otitis media through a primary care-based multifaceted educational intervention: study protocol for a cluster randomised controlled trial. Trials 2018;19(1):501

Sjoukes A, Venekamp RP, van de Pol AC, Hay AD, Little P, Schilder AG, Damoiseaux RA.
Paracetamol (acetaminophen) or non-steroidal anti-inflammatory drugs, alone or combined, for pain relief in acute otitis media in children. Cochrane Database of Systematic Reviews 2016, Issue 12. Art. No.: CD011534. DOI: 10.1002/14651858.CD011534.pub2.

Deniz, Y*, van Uum, RT*, de Hoog, MLA, Schilder, AGM, Damoisaux, RAMJ, Venekamp, RP. Impact of acute otitis media clinical practice guidelines on antibiotic and analgesic prescriptions: a systematic review. Arch Dis Child 2018:0;1-6. DOI: 10.1136/archdischild-2017-314103

Presentations

General practice Research on Infections Network (GRIN) meeting 2015, Galway (Ireland)
Sjoukes A*, Venekamp RP, van de Pol AC, Schilder AGM, Damoiseaux RAMJ. Pain Intensity Monitoring in Paediatric Otitis Media (PIM-POM) study.

NHG Wetenschapsdag (Dutch College of General Practitioners Scientific Congress) 2017, Zeist (Netherlands)
Deniz Y, Sjoukes A, de Hoog MLA, Schilder AGM, Damoisaux RAMJ, Venekamp RP*. Otitis media acuta bij kinderen; impact van richtlijnen op voorschrijfgedrag van artsen.

General practice Research on Infections Network (GRIN) meeting 2017, Oslo (Norway)
Deniz Y, van Uum RT*, de Hoog MLA, Schilder AGM, Damoisaux RAMJ, Venekamp RP. Impact of acute otitis media clinical practice guidelines on physicians’ prescribing behaviour: a systematic review.

Van Uum RT, Sjoukes A, de Groot E, Venekamp RP, Schilder AGM, Damoiseaux RAMJ, Anthierens S*. General practitioners’ views and experiences of a primary care-based multifaceted intervention to optimise pain management in children with acute otitis media.

WONCA Europe 2018, Kraków (Poland) 
Deniz Y, van Uum RT*, de Hoog MLA, Schilder AGM, Damoisaux RAMJ, Venekamp RP. Impact of acute otitis media clinical practice guidelines on physicians’ prescribing behaviour: a systematic review.
Van Uum RT*, Sjoukes A, de Groot E, Venekamp RP, Schilder AGM, Damoiseaux RAMJ, Anthierens S. General practitioners’ views on and experiences with a primary care-based multifaceted educational intervention to optimise pain management in children with acute otitis media

NHG Wetenschapsdag (Dutch College of General Practitioners Scientific Congress) 2018, Amsterdam (Netherlands)
Van Uum RT*, Sjoukes A, de Groot E, Venekamp RP, Schilder AGM, Damoiseaux RAMJ, Anthierens S. General practitioners’ views on and experiences with a primary care-based multifaceted educational intervention to optimise pain management in children with acute otitis media

Workgroup uitklapper, klik om te openen

Research team
Prof. Roger Damoiseaux, PhD
Prof. Anne Schilder, PhD
Roderick Venekamp, PhD    
Drs. Rick T. van Uum

Collaborators
Ardine G. de Wit, PhD
Esther de Groot, PhD
Marieke L.A. de Hoog, PhD
Sibyl Anthierens, PhD
Alma C. van der Pol, PhD

Contact uitklapper, klik om te openen

For more information regarding the PIM-POM study, please contact:

Coordinating investigator
Drs Rick T. van Uum
email: r.t.vanuum-2@umcutrecht.nl
Phone: 088 - 75 63511
mobile: 06 - 25325671

Independent researcher
Tom Wolf, PhD
Paediatric infectious diseases specialist.
Phone: 088 - 755 45 54