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The AWESCORE, a patient-reported outcome measure: development, feasibility, reliability, validity and responsiveness for adults with cystic fibrosis

Brenda M. Button, Lisa M. Wilson, Angela T. Burge, Lara Kimmel, Felicity Finlayson, Elyssa Williams, Anthony Talbot, Audrey Tierney, Susannah King, Anne E. Holland, Dominic Keating, Tom Kotsimbos, John W. Wilson
ERJ Open Research 2021 7: 00120-2021; DOI: 10.1183/23120541.00120-2021
Brenda M. Button
1Alfred Health, Prahran, Melbourne, Australia
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  • For correspondence: b.button@alfred.org.au
Lisa M. Wilson
1Alfred Health, Prahran, Melbourne, Australia
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Angela T. Burge
2Monash University, School of Medicine, Prahran, Melbourne, Australia
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Lara Kimmel
1Alfred Health, Prahran, Melbourne, Australia
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Felicity Finlayson
1Alfred Health, Prahran, Melbourne, Australia
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  • ORCID record for Felicity Finlayson
Elyssa Williams
1Alfred Health, Prahran, Melbourne, Australia
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Anthony Talbot
1Alfred Health, Prahran, Melbourne, Australia
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Audrey Tierney
3School of Allied Health, University of Limerick, Limerick, Ireland
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Susannah King
1Alfred Health, Prahran, Melbourne, Australia
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Anne E. Holland
2Monash University, School of Medicine, Prahran, Melbourne, Australia
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Dominic Keating
1Alfred Health, Prahran, Melbourne, Australia
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Tom Kotsimbos
2Monash University, School of Medicine, Prahran, Melbourne, Australia
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John W. Wilson
2Monash University, School of Medicine, Prahran, Melbourne, Australia
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  • FIGURE 1
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    FIGURE 1

    a) Reliability: Bland–Altman plot for total AWESCORES (n=20, 1 month apart, clinical stability). Solid line represents mean change in AWESCORE; dashed line represents the limits of agreement (1.96×sd of the mean change in AWESCORE). b) Reliability: Bland–Altman plot for total AWESCORES (n=40). Solid line represents mean change in AWESCORE; dashed line represents the limits of agreement (1.96×sd of the mean change in AWESCORE).

Tables

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  • TABLE 1

    Participant characteristics for each study component

    Clinical statusCombinedFeasibility and known-groups validity#Concurrent validity¶ and reliability+Reliability§Responsivenessƒ
    StableExacerbationStableCombinedStableExacerbationStableExacerbation
    n24618363204027136060
    Male sex n1291002912191362828
    Age years (mean±sd)31±1033±1133±1033±1032±933±1033±10-
    FEV1 % predicted (mean±sd)64±2354±2054±1954±1957±2253±1855±1742±16

    #: participants in outpatient clinic, completed AWESCORE once (clinically stable OR exacerbation). ¶: participants in outpatient clinic, completed AWESCORE and CFQ-R once (clinically stable). +: participants in outpatient clinic, completed AWESCORE twice 1 month apart (clinically stable). §: participants in outpatient clinic, completed AWESCORE twice at one visit (clinically stable) OR inpatient admission, completed AWESCORE twice within 24 h (exacerbation). ƒ: participants in outpatient clinic, completed AWESCORE once (clinically stable) and inpatient admission, completed AWESCORE once (exacerbation).

    • TABLE 2

      Known-groups validity: domain AWESCORES for clinically stable participants and participants with an acute exacerbation

      Domain AWESCORESClinical stability#Acute exacerbation¶Mann–Whitney U-test
      Cough7 (6–8)4 (3–4)<0.001
      Sputum7 (6–8)4 (3–5)<0.001
      Energy7 (6–8)4 (3–5)<0.001
      Exercise7 (5–8)4 (3–6)<0.001
      Appetite8 (7–10)5 (4–7)<0.001
      Weight8 (7–9)5 (4–8)<0.001
      Mood8 (7–9)5 (4–7)<0.001
      Anxiety8 (6–9)6 (4–8)<0.001
      Sleep7 (6–8)4 (3–6)<0.001
      General health7 (6–8)5 (3–6)<0.001

      Data are median (IQR), p<0.001. #: n=183. ¶: n=63.

      • TABLE 3

        Reliability: AWESCORES at times A and B (n=40)

        AWESCORESTime ATime BWilcoxon signed rank testICC (95% CI)
        domainsZp-value
        Cough5 (4–7)5 (4–7)−0.2020.840.910 (0.836–0.951)
        Sputum6 (4–7)5 (4–7)−0.9220.360.900 (0.820–0.946)
        Energy5 (3–8)5 (4–7)−0.3470.730.937 (0.885–0.966)
        Exercise6 (4–8)5 (4–8)−0.4470.650.959 (0.924–0.978)
        Appetite7 (5–9)7 (4–9)−1.4950.140.937 (0.884–0.966)
        Weight7 (4–8)7 (4–9)−0.2290.820.972 (0.947–0.985)
        Mood7 (5–8)7 (5–8)−0.8650.390.874 (0.775–0.931)
        Anxiety7 (5–9)7 (4–9)−0.4200.670.906 (0.830–0.949)
        Sleep7 (4–8)7 (4–8)−0.1930.850.950 (0.907–0.973)
        General healthMean±sd: 6±2Mean±sd: 6±2Mean difference# −0.225 (95% CI −0.409 to −0.041)0.956 (0.918–0.976)

        Data are median (IQR) except where indicated. ICC: intraclass coefficient; sd: standard deviation. #: t-test as data normally distributed; p<0.05.

        • TABLE 4

          Responsiveness: domain AWESCORES for participants (n=60) in clinical stability and during an acute exacerbation

          Domain AWESCORESClinical stabilityAcute exacerbationWilcoxon signed rank test
          Zp-value
          Cough7 (6–8)4 (3–5)−6.526<0.001
          Sputum7 (6–8)4 (3–5)−6.454<0.001
          Energy8 (6–9)4 (3–5)−6.499<0.001
          Exercise7 (6–9)3 (2–5)−6.609<0.001
          Appetite8 (8–9)5 (3–7)−6.073<0.001
          Weight8 (7–9)6 (4–8)−5.616<0.001
          Mood8 (8–9)5 (4–7)−6.203<0.001
          Anxiety9 (7–10)7 (5–8)−4.735<0.001
          Sleep8 (6–8)4 (3–6)−5.766<0.001
          General health7 (7–8)5 (3–6)−6.481<0.001

          Data are median (IQR); p<0.05.

          Supplementary Materials

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            Supplementary material 00120-2021.supplement

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          The AWESCORE, a patient-reported outcome measure: development, feasibility, reliability, validity and responsiveness for adults with cystic fibrosis
          Brenda M. Button, Lisa M. Wilson, Angela T. Burge, Lara Kimmel, Felicity Finlayson, Elyssa Williams, Anthony Talbot, Audrey Tierney, Susannah King, Anne E. Holland, Dominic Keating, Tom Kotsimbos, John W. Wilson
          ERJ Open Research Jul 2021, 7 (3) 00120-2021; DOI: 10.1183/23120541.00120-2021

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          The AWESCORE, a patient-reported outcome measure: development, feasibility, reliability, validity and responsiveness for adults with cystic fibrosis
          Brenda M. Button, Lisa M. Wilson, Angela T. Burge, Lara Kimmel, Felicity Finlayson, Elyssa Williams, Anthony Talbot, Audrey Tierney, Susannah King, Anne E. Holland, Dominic Keating, Tom Kotsimbos, John W. Wilson
          ERJ Open Research Jul 2021, 7 (3) 00120-2021; DOI: 10.1183/23120541.00120-2021
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