Effectiveness of a cough management algorithm at the transitional phase from acute to chronic cough in Australian children aged <15 years

Protocol for a randomised controlled trial

Kerry Ann F O'Grady, Keith Grimwood, Maree Toombs, Theo P Sloots, Michael Otim, David M Whiley, Jennie Anderson, Sheree Rablin, Paul J. Torzillo, Helen Buntain, Anne Connor, Don Adsett, Oon Meng kar, Anne B. Chang

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    Abstract

    Introduction: Acute respiratory infections (ARIs) are leading causes of hospitalisation in Australian children and, if recurrent, are associated with increased risk of chronic pulmonary disorders later in life. Chronic (>4â €..weeks) cough in children following ARI is associated with decreased quality-of-life scores and increased health and societal economic costs. We will determine whether a validated evidence-based cough algorithm, initiated when chronic cough is first diagnosed after presentation with ARI, improves clinical outcomes in children compared with usual care.

    Methods and analysis: A multicentre, parallel group, open-label, randomised controlled trial, nested within a prospective cohort study in Southeast Queensland, Australia, is underway. 750 children aged <15â €..years will be enrolled and followed weekly for 8â €..weeks after presenting with an ARI with cough. 214 children from this cohort with persistent cough at day 28 will be randomised to either early initiation of a cough management algorithm or usual care (107 per group). Randomisation is stratified by reason for presentation, site and total cough duration at day 28 (<6 and ≥6â €..weeks). Demographic details, risk factors, clinical histories, examination findings, cost-of-illness data, an anterior nasal swab and parent and child exhaled carbon monoxide levels (when age appropriate) are collected at enrolment. Weekly contacts will collect cough status and cost-of-illness data. Additional nasal swabs are collected at days 28 and 56. The primary outcome is time-To-cough resolution. Secondary outcomes include direct and indirect costs of illness and the predictors of chronic cough postpresentation.

    Ethics and dissemination: The Children's Health Queensland (HREC/15/QRCH/15) and the Queensland University of Technology University (1500000132) Research Ethics Committees have approved the study. The study will inform best-practice management of cough in children.

    Trial registration number: ACTRN12615000132549.

    Original languageEnglish
    Article numbere013796
    Pages (from-to)1-12
    Number of pages12
    JournalBMJ Open
    Volume7
    Issue number3
    DOIs
    Publication statusPublished - 1 Mar 2017

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    Cough
    Randomized Controlled Trials
    Respiratory Tract Infections
    Cost of Illness
    Queensland
    Nose
    Research Ethics Committees
    Practice Management
    Carbon Monoxide
    Random Allocation
    Practice Guidelines
    Ethics
    Hospitalization
    Cohort Studies
    Economics
    Quality of Life
    Demography
    Prospective Studies
    Technology
    Costs and Cost Analysis

    Cite this

    O'Grady, Kerry Ann F ; Grimwood, Keith ; Toombs, Maree ; Sloots, Theo P ; Otim, Michael ; Whiley, David M ; Anderson, Jennie ; Rablin, Sheree ; Torzillo, Paul J. ; Buntain, Helen ; Connor, Anne ; Adsett, Don ; Meng kar, Oon ; Chang, Anne B. / Effectiveness of a cough management algorithm at the transitional phase from acute to chronic cough in Australian children aged <15 years : Protocol for a randomised controlled trial. In: BMJ Open. 2017 ; Vol. 7, No. 3. pp. 1-12.
    @article{e230591e5b0240089de9e29a32d04ba5,
    title = "Effectiveness of a cough management algorithm at the transitional phase from acute to chronic cough in Australian children aged <15 years: Protocol for a randomised controlled trial",
    abstract = "Introduction: Acute respiratory infections (ARIs) are leading causes of hospitalisation in Australian children and, if recurrent, are associated with increased risk of chronic pulmonary disorders later in life. Chronic (>4{\^a} €..weeks) cough in children following ARI is associated with decreased quality-of-life scores and increased health and societal economic costs. We will determine whether a validated evidence-based cough algorithm, initiated when chronic cough is first diagnosed after presentation with ARI, improves clinical outcomes in children compared with usual care. Methods and analysis: A multicentre, parallel group, open-label, randomised controlled trial, nested within a prospective cohort study in Southeast Queensland, Australia, is underway. 750 children aged <15{\^a} €..years will be enrolled and followed weekly for 8{\^a} €..weeks after presenting with an ARI with cough. 214 children from this cohort with persistent cough at day 28 will be randomised to either early initiation of a cough management algorithm or usual care (107 per group). Randomisation is stratified by reason for presentation, site and total cough duration at day 28 (<6 and ≥6{\^a} €..weeks). Demographic details, risk factors, clinical histories, examination findings, cost-of-illness data, an anterior nasal swab and parent and child exhaled carbon monoxide levels (when age appropriate) are collected at enrolment. Weekly contacts will collect cough status and cost-of-illness data. Additional nasal swabs are collected at days 28 and 56. The primary outcome is time-To-cough resolution. Secondary outcomes include direct and indirect costs of illness and the predictors of chronic cough postpresentation. Ethics and dissemination: The Children's Health Queensland (HREC/15/QRCH/15) and the Queensland University of Technology University (1500000132) Research Ethics Committees have approved the study. The study will inform best-practice management of cough in children. Trial registration number: ACTRN12615000132549.",
    keywords = "children, chronic cough, cost effectiveness, intervention, randomised controlled trial",
    author = "O'Grady, {Kerry Ann F} and Keith Grimwood and Maree Toombs and Sloots, {Theo P} and Michael Otim and Whiley, {David M} and Jennie Anderson and Sheree Rablin and Torzillo, {Paul J.} and Helen Buntain and Anne Connor and Don Adsett and {Meng kar}, Oon and Chang, {Anne B.}",
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    O'Grady, KAF, Grimwood, K, Toombs, M, Sloots, TP, Otim, M, Whiley, DM, Anderson, J, Rablin, S, Torzillo, PJ, Buntain, H, Connor, A, Adsett, D, Meng kar, O & Chang, AB 2017, 'Effectiveness of a cough management algorithm at the transitional phase from acute to chronic cough in Australian children aged <15 years: Protocol for a randomised controlled trial', BMJ Open, vol. 7, no. 3, e013796, pp. 1-12. https://doi.org/10.1136/bmjopen-2016-013796

    Effectiveness of a cough management algorithm at the transitional phase from acute to chronic cough in Australian children aged <15 years : Protocol for a randomised controlled trial. / O'Grady, Kerry Ann F; Grimwood, Keith; Toombs, Maree; Sloots, Theo P; Otim, Michael; Whiley, David M; Anderson, Jennie; Rablin, Sheree; Torzillo, Paul J.; Buntain, Helen; Connor, Anne; Adsett, Don; Meng kar, Oon; Chang, Anne B.

    In: BMJ Open, Vol. 7, No. 3, e013796, 01.03.2017, p. 1-12.

    Research output: Contribution to journalArticleResearchpeer-review

    TY - JOUR

    T1 - Effectiveness of a cough management algorithm at the transitional phase from acute to chronic cough in Australian children aged <15 years

    T2 - Protocol for a randomised controlled trial

    AU - O'Grady, Kerry Ann F

    AU - Grimwood, Keith

    AU - Toombs, Maree

    AU - Sloots, Theo P

    AU - Otim, Michael

    AU - Whiley, David M

    AU - Anderson, Jennie

    AU - Rablin, Sheree

    AU - Torzillo, Paul J.

    AU - Buntain, Helen

    AU - Connor, Anne

    AU - Adsett, Don

    AU - Meng kar, Oon

    AU - Chang, Anne B.

    PY - 2017/3/1

    Y1 - 2017/3/1

    N2 - Introduction: Acute respiratory infections (ARIs) are leading causes of hospitalisation in Australian children and, if recurrent, are associated with increased risk of chronic pulmonary disorders later in life. Chronic (>4â €..weeks) cough in children following ARI is associated with decreased quality-of-life scores and increased health and societal economic costs. We will determine whether a validated evidence-based cough algorithm, initiated when chronic cough is first diagnosed after presentation with ARI, improves clinical outcomes in children compared with usual care. Methods and analysis: A multicentre, parallel group, open-label, randomised controlled trial, nested within a prospective cohort study in Southeast Queensland, Australia, is underway. 750 children aged <15â €..years will be enrolled and followed weekly for 8â €..weeks after presenting with an ARI with cough. 214 children from this cohort with persistent cough at day 28 will be randomised to either early initiation of a cough management algorithm or usual care (107 per group). Randomisation is stratified by reason for presentation, site and total cough duration at day 28 (<6 and ≥6â €..weeks). Demographic details, risk factors, clinical histories, examination findings, cost-of-illness data, an anterior nasal swab and parent and child exhaled carbon monoxide levels (when age appropriate) are collected at enrolment. Weekly contacts will collect cough status and cost-of-illness data. Additional nasal swabs are collected at days 28 and 56. The primary outcome is time-To-cough resolution. Secondary outcomes include direct and indirect costs of illness and the predictors of chronic cough postpresentation. Ethics and dissemination: The Children's Health Queensland (HREC/15/QRCH/15) and the Queensland University of Technology University (1500000132) Research Ethics Committees have approved the study. The study will inform best-practice management of cough in children. Trial registration number: ACTRN12615000132549.

    AB - Introduction: Acute respiratory infections (ARIs) are leading causes of hospitalisation in Australian children and, if recurrent, are associated with increased risk of chronic pulmonary disorders later in life. Chronic (>4â €..weeks) cough in children following ARI is associated with decreased quality-of-life scores and increased health and societal economic costs. We will determine whether a validated evidence-based cough algorithm, initiated when chronic cough is first diagnosed after presentation with ARI, improves clinical outcomes in children compared with usual care. Methods and analysis: A multicentre, parallel group, open-label, randomised controlled trial, nested within a prospective cohort study in Southeast Queensland, Australia, is underway. 750 children aged <15â €..years will be enrolled and followed weekly for 8â €..weeks after presenting with an ARI with cough. 214 children from this cohort with persistent cough at day 28 will be randomised to either early initiation of a cough management algorithm or usual care (107 per group). Randomisation is stratified by reason for presentation, site and total cough duration at day 28 (<6 and ≥6â €..weeks). Demographic details, risk factors, clinical histories, examination findings, cost-of-illness data, an anterior nasal swab and parent and child exhaled carbon monoxide levels (when age appropriate) are collected at enrolment. Weekly contacts will collect cough status and cost-of-illness data. Additional nasal swabs are collected at days 28 and 56. The primary outcome is time-To-cough resolution. Secondary outcomes include direct and indirect costs of illness and the predictors of chronic cough postpresentation. Ethics and dissemination: The Children's Health Queensland (HREC/15/QRCH/15) and the Queensland University of Technology University (1500000132) Research Ethics Committees have approved the study. The study will inform best-practice management of cough in children. Trial registration number: ACTRN12615000132549.

    KW - children

    KW - chronic cough

    KW - cost effectiveness

    KW - intervention

    KW - randomised controlled trial

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    U2 - 10.1136/bmjopen-2016-013796

    DO - 10.1136/bmjopen-2016-013796

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