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Minimal clinically important difference in idiopathic pulmonary fibrosis

Mohleen Kang, Lucian Marts, Jordan A. Kempker, Srihari Veeraraghavan
Breathe 2021 17: 200345; DOI: 10.1183/20734735.0345-2020
Mohleen Kang
Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Emory University School of Medicine, Atlanta, GA, USA
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  • ORCID record for Mohleen Kang
  • For correspondence: mkang30@emory.edu1
Lucian Marts
Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Emory University School of Medicine, Atlanta, GA, USA
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Jordan A. Kempker
Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Emory University School of Medicine, Atlanta, GA, USA
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  • ORCID record for Jordan A. Kempker
Srihari Veeraraghavan
Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Emory University School of Medicine, Atlanta, GA, USA
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Tables

  • Table 1

    Summary of commonly used anchor-based methods

    MethodExplanationComment
    JaeschkeMean (Cfollow-up−Cbaseline)Regression to the mean
    Mean change, RedelmeierMean (Cfollow-up−Cbaseline)–Mean (Ufollow-up−Ubaseline)Regression to the mean
    Receiver operating curveCut-off point where sensitivity+specificity is maximised between changed and unchangedNon-parametric
    Random sample variation
    Change analysed separately for worsening and improvement
    Regression modellingTransition variable# as independent or dependent variableControl for confounding and effect modification

    Cfollow-up: follow-up score of patients who are changed based on response to anchor; Cbaseline: baseline score of patients who are changed based on response to anchor; Ufollow-up: follow-up score of patients who are unchanged based on response to anchor; Ubaseline: baseline score of patients who are unchanged based on response to anchor. #: transition variable (usually coded as 1 if changed based on response to anchor or 0 if unchanged based on anchor).

    • Table 2

      Summary of MCID values of physiological and patient-reported outcome measures in patients with IPF

      VariableAuthor [ref.]Time period weeksSample size (disease severity)AnchorsDistribution method usedImprovement or deteriorationMCID value
      FVC % predDu Bois [14]481156 (mild-to-moderate)SF-2
      Hospitalisation
      Death
      YesBoth2–6%
      6MWD mDu Bois [18]48826 (mild-to-moderate)Hospitalisation
      Death
      YesBoth24–45#
      Nathan [19]48338 (mild-to-moderate)Hospitalisation
      Death
      YesBoth21.7–37.0#
      Swigris [20]52123 (mild-to-moderate)FVC
      SGRQ
      YesBoth28
      ISW mNolan [37]877 patients¶GRCQYesImprovement31–46#
      Total SGRQSwigris [22]26129 (mild-to-moderate)FVC TDIYesBoth7 (5–10)+
      Swigris [23]521061 (mild-to-moderate)FVC
      UCSD SOBQ
      PGI-C
      YesBoth4–5
      SGRQ-IPrior [24]52124 (mild-to-moderate)FVC
      DLCO
      6MWD
      GRCS
      UCSD SOBQ
      SGRQ
      NoImprovement3.9
      Deterioration4.9
      UCSD SOBQSwigris [25]24180 (severe)SGRQ-AYesBoth8 (5–11)+
      SF-36Swigris [22]26129 (mild-to-moderate)FVCYesBoth3 (MCS)
      TDI3 (PCS)
      Witt [27]§258¶6MWD
      FVC
      DLCO
      YesBoth6 (MCS)
      5 (PCS)
      KBILDPrior [24]52124 (mild-to-moderate)FVC
      DLCO
      6MWD
      GRCS
      UCSD SOBQ
      SGRQ
      NoImprovement4.7
      Deterioration2.7

      SGRQ-I: SGRQ for patients with IPF; SF-36: Short-Form Health Survey 36; SF-2: health transition question in SF-36 questionnaire; GRCQ: Global Rating of Change Questionnaire; TDI: Transition Dyspnea Index; PGI-C: Patient's Global Impression of Change; DLCO: diffusing capacity of the lung for carbon monoxide; GRCS: Global Rating of Change Scales; SGRQ-A: SGRQ activity domain; MCS: mental component score; PCS: physical component score. #: range; ¶: no set inclusion criteria based on disease severity; +: point estimate (range); §: no a priori follow-up time.

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      Minimal clinically important difference in idiopathic pulmonary fibrosis
      Mohleen Kang, Lucian Marts, Jordan A. Kempker, Srihari Veeraraghavan
      Breathe Jun 2021, 17 (2) 200345; DOI: 10.1183/20734735.0345-2020

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      Minimal clinically important difference in idiopathic pulmonary fibrosis
      Mohleen Kang, Lucian Marts, Jordan A. Kempker, Srihari Veeraraghavan
      Breathe Jun 2021, 17 (2) 200345; DOI: 10.1183/20734735.0345-2020
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