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      Improving pain management in childhood acute otitis media in general practice: a cluster randomised controlled trial of a GP-targeted educational intervention

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          Abstract

          Background

          Pain management in acute otitis media (AOM) is often suboptimal, potentially leading to unnecessary discomfort, GP reconsultation, and antibiotic prescribing.

          Aim

          To assess the effectiveness of a GP-targeted educational intervention to improve pain management in children with AOM.

          Design and setting

          Pragmatic, cluster randomised controlled trial (RCT). GPs in 37 practices (intervention n = 19; control n = 18) across the Netherlands recruited 224 children with GP-confirmed AOM and ear pain (intervention n = 94; control n = 130) between February 2015 and May 2018.

          Method

          GPs in practices allocated to the intervention group were trained (online and face-to-face) to discuss pain management with parents using an information leaflet, and prompted to prescribe weight-appropriate dosed paracetamol. Ibuprofen was additionally prescribed if pain control was still insufficient. GPs in the control group provided usual care.

          Results

          Mean ear pain scores over the first 3 days were similar between groups (4.66 versus 4.36; adjusted mean difference = −0.05; 95% confidence intervals [CI] = −0.93 to 0.83), whereas analgesic use, in particular ibuprofen, was higher in the intervention group. The total number of antibiotic prescriptions during the 28-day follow-up was similar (mean rate 0.43 versus 0.47; adjusted rate ratio [aRR] 0.97; 95% CI = 0.68 to 1.38). Parents of children in the intervention group were more likely to reconsult for AOM-related complaints (mean rate 0.70 versus 0.41; aRR 1.73; 95% CI = 1.14 to 2.62).

          Conclusion

          An intervention aimed at improving pain management for AOM increases analgesic use, particularly ibuprofen, but does not provide symptomatic benefit. GPs are advised to carefully weigh the potential benefits of ibuprofen against its possible harms.

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          Most cited references52

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          Developing and evaluating complex interventions: the new Medical Research Council guidance

          Evaluating complex interventions is complicated. The Medical Research Council's evaluation framework (2000) brought welcome clarity to the task. Now the council has updated its guidance
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            EuroQol: the current state of play.

            R. Brooks (1996)
            The EuroQol Group first met in 1987 to test the feasibility of jointly developing a standardised non-disease-specific instrument for describing and valuing health-related quality of life. From the outset the Group has been multi-country, multi-centre, and multi-disciplinary. The EuroQol instrument is intended to complement other forms of quality of life measures, and it has been purposefully developed to generate a cardinal index of health, thus giving it considerable potential for use in economic evaluation. Considerable effort has been invested by the Group in the development and valuation aspects of health status measurement. Earlier work was reported upon in 1990; this paper is a second 'corporate' effort detailing subsequent developments. The concepts underlying the EuroQol framework are explored with particular reference to the generic nature of the instrument. The valuation task is reviewed and some evidence on the methodological requirements for measurement is presented. A number of special issues of considerable interest and concern to the Group are discussed: the modelling of data, the duration of health states and the problems surrounding the state 'dead'. An outline of some of the applications of the EuroQol instrument is presented and a brief commentary on the Group's ongoing programme of work concludes the paper.
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              Review: a gentle introduction to imputation of missing values.

              In most situations, simple techniques for handling missing data (such as complete case analysis, overall mean imputation, and the missing-indicator method) produce biased results, whereas imputation techniques yield valid results without complicating the analysis once the imputations are carried out. Imputation techniques are based on the idea that any subject in a study sample can be replaced by a new randomly chosen subject from the same source population. Imputation of missing data on a variable is replacing that missing by a value that is drawn from an estimate of the distribution of this variable. In single imputation, only one estimate is used. In multiple imputation, various estimates are used, reflecting the uncertainty in the estimation of this distribution. Under the general conditions of so-called missing at random and missing completely at random, both single and multiple imputations result in unbiased estimates of study associations. But single imputation results in too small estimated standard errors, whereas multiple imputation results in correctly estimated standard errors and confidence intervals. In this article we explain why all this is the case, and use a simple simulation study to demonstrate our explanations. We also explain and illustrate why two frequently used methods to handle missing data, i.e., overall mean imputation and the missing-indicator method, almost always result in biased estimates.
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                Author and article information

                Contributors
                Role: GP in training
                Role: GP and assistant professor
                Role: Statistician
                Role: GP
                Role: GP and assistant professor
                Role: Professor of paediatric otorhinolaryngology
                Role: GP and professor of primary care
                Journal
                Br J Gen Pract
                Br J Gen Pract
                bjgp
                bjgp
                The British Journal of General Practice
                Royal College of General Practitioners
                0960-1643
                1478-5242
                October 2020
                25 August 2020
                25 August 2020
                : 70
                : 699
                : e684-e695
                Affiliations
                Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
                Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
                Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
                Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
                Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
                University College London; National Institute for Health Research research professor evidENT, Ear Institute, University College London Hospitals Biomedical Research Centre, London, UK.
                Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
                Author notes
                Address for correspondence Rick van Uum, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA Utrecht, the Netherlands. Email: R.T.vanUum-2@ 123456umcutrecht.nl
                Article
                10.3399/bjgp20X712589
                7449377
                32839161
                8e69663f-15e7-4672-8f03-b3048f80712e
                ©The Authors

                This article is Open Access: CC BY 4.0 licence ( http://creativecommons.org/licences/by/4.0/).

                History
                : 20 November 2019
                : 16 February 2020
                : 15 March 2020
                Categories
                Research

                acute otitis media,child health,primary care,pain management,educational intervention

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