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      Feasibility cluster randomised controlled trial of a within-consultation intervention to reduce antibiotic prescribing for children presenting to primary care with acute respiratory tract infection and cough

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          Abstract

          Objective

          To investigate recruitment and retention, data collection methods and the acceptability of a ‘within-consultation’ complex intervention designed to reduce antibiotic prescribing.

          Design

          Primary care feasibility cluster randomised controlled trial.

          Setting

          32 general practices in South West England recruiting children from October 2014 to April 2015.

          Participants

          Children (aged 3 months to <12 years) with acute cough and respiratory tract infection (RTI).

          Intervention

          A web-based clinician-focussed clinical rule to predict risk of future hospitalisation and a printed leaflet with individualised child health information for carers, safety-netting advice and a treatment decision record.

          Controls

          Usual practice, with clinicians recording data on symptoms, signs and treatment decisions.

          Results

          Of 542 children invited, 501 (92.4%) consented to participate, a month ahead of schedule. Antibiotic prescribing data were collected for all children, follow-up data for 495 (98.8%) and the National Health Service resource use data for 494 (98.6%). The overall antibiotic prescribing rates for children’s RTIs were 25% and 15.8% (p=0.018) in intervention and control groups, respectively. We found evidence of postrandomisation differential recruitment: the number of children recruited to the intervention arm was higher (292 vs 209); over half were recruited by prescribing nurses compared with less than a third in the control arm; children in the intervention arm were younger (median age 2 vs 3 years controls, p=0.03) and appeared to be more unwell than those in the control arm with higher respiratory rates (p<0.0001), wheeze prevalence (p=0.007) and global illness severity scores assessed by carers (p=0.045) and clinicians (p=0.01). Interviews with clinicians confirmed preferential recruitment of less unwell children to the trial, more so in the control arm.

          Conclusion

          Differential recruitment may explain the paradoxical antibiotic prescribing rates. Future cluster level studies should consider designs which remove the need for individual consent postrandomisation and embed the intervention within electronic primary care records.

          Trial registration number

          ISRCTN 23547970

          UKCRN study ID

          16891

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          Most cited references22

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          Consort 2010 statement: extension to cluster randomised trials.

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            Using thematic analysis in psychology

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              The prevalence of symptoms and consultations in pre-school children in the Avon Longitudinal Study of Parents and Children (ALSPAC): a prospective cohort study.

              Pre-school children are frequent users of health services, but little contemporary data are available describing their symptoms or why they consult. To describe symptom and consultation prevalence in pre-school children and to identify the socio-demographic factor or factors associated with consultations for those symptoms. Prospective cohort study of 13,617 pre-school children living in south-west England. Parents completed questionnaires asking about symptoms and consultations for those symptoms at six, 18, 30, 42 and 57 months. During the pre-school years, all children experienced one or more symptoms, most commonly cold, cough, high temperature, vomiting or diarrhoea. Ninety seven percent consulted a doctor at least once, most commonly for cough, high fever and/or earache. Lower parity was most strongly and consistently associated with higher consultation rates. Fever, respiratory and gastro-intestinal symptoms are a normal part of pre-school life. Research of acute conditions in young children could focus on the most common symptoms leading to consultation, namely cough, fever and earache. Efforts to support parents' help seeking decision making might usefully be targeted at first time parents.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2017
                9 May 2017
                : 7
                : 5
                : e014506
                Affiliations
                [1 ] departmentCentre for Child and Adolescent Health, School of Social & Community Medicine , University of Bristol , Bristol, UK
                [2 ] departmentCentre for Academic Primary Care, School of Social and Community Medicine , University of Bristol , Bristol, UK
                [3 ] departmentNational Institute for Health Research Collaborations for Leadership in Applied Health Research and Care West (NIHR CLAHRC West) , University Hospitals Bristol NHS Foundation Trust , UK
                [4 ] departmentSchool for Policy Studies , University of Bristol , Bristol, UK
                [5 ] departmentSchool of Social and Community Medicine , University of Bristol , Bristol, UK
                [6 ] departmentSchool of Clinical Sciences , University of Bristol , Bristol, UK
                [7 ] departmentDepartment of Primary Care & Population Sciences , University of Southampton , Southampton, UK
                [8 ] departmentDivision of Population Medicine , Cardiff University , UK
                Author notes
                [Correspondence to ] Dr Peter S Blair; p.s.blair@ 123456bris.ac.uk
                Author information
                http://orcid.org/0000-0003-0782-3117
                Article
                bmjopen-2016-014506
                10.1136/bmjopen-2016-014506
                5623421
                28490554
                d9b0d02e-b6bf-4f02-9b09-845c34d59711
                © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

                This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

                History
                : 29 September 2016
                : 02 February 2017
                : 14 February 2017
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100007602, Programme Grants for Applied Research;
                Categories
                General practice / Family practice
                Research
                1506
                1696
                Custom metadata
                unlocked

                Medicine
                randomised controlled trial (rct),feasibility,children,respiratory tract infections (rtis),primary care,cough,antibiotics (or anti-microbial agents)

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