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Interpreting thresholds for a clinically significant change in health status in asthma and COPD

P.W. Jones
European Respiratory Journal 2002 19: 398-404; DOI: 10.1183/09031936.02.00063702
P.W. Jones
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    Fig. 1.—

    Changes in the Asthma Quality of Life Questionnaire (AQLQ) score with salmeterol compared with regular four-times daily salbutamol in patients (n) with asthma (adapted from 6). The threshold for clincially significant change is equal to 0.5. ***: p<0.001 versus salbutamol; #: p=0.022.

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    Fig. 2.—

    Changes in the St George's Respiratory Questionnaire (SGRQ) score following 1 yr of therapy with nedocromil sodium or placebo in patients with asthma, compared with the patients' retrospective estimate of the treatment's efficacy 14, 15. The patients were blind to their previous and current SGRQ scores when they judged the efficacy of the treatment. Circles represent the mean; whiskers represent 95% confidence intervals. ═: no change from baseline; - - -: the threshold for clinical significance. Very effective: n=139; Moderately effective: n=164; Slightly effective: n=97; No effect: n=108.

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    Fig. 3.—

    Method of categorizing clinical trials results using the threshold for clinical significance and the confidence intervals around the mean treatment effect. See text for a further explanation. Solid line represents the threshold for minimum clinically significant effect. Boxes represent 95% confidence intervals.

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  • Table 1

    Five scenarios that illustrate different patterns of change a 4 unit change in the St George's Respiratory Questionnaire Score

    Patient no.Scenario
    1Attacks of wheeze change from most days a week to a few days a month, no more morning chest tightness, no longer breathless on playing sports and games and now only restricted in one or two activities that she wants to do compared to most things (which was the case previously).
    2No more disturbed sleep due to coughing, now able to play tennis and no longer embarrassed by cough and breathing in public.
    3No longer takes a long time to wash or dress, can now walk up stairs without stopping and go out for entertainment.
    4Things no longer seem to require too much effort, no longer has to stop for rests while doing housework and can now carry things upstairs.
    5No longer has to walk more slowly than other people, no longer breathless on getting washed and dressed or on bending over.
    • Patients one and two would be typically young adult asthmatic patients, whereas me scenarios illustrated by patient's three to five would occur in patients with chronic obstructive pulmonary disease

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Interpreting thresholds for a clinically significant change in health status in asthma and COPD
P.W. Jones
European Respiratory Journal Mar 2002, 19 (3) 398-404; DOI: 10.1183/09031936.02.00063702

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Interpreting thresholds for a clinically significant change in health status in asthma and COPD
P.W. Jones
European Respiratory Journal Mar 2002, 19 (3) 398-404; DOI: 10.1183/09031936.02.00063702
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  • Article
    • Abstract
    • What is a clinically significant threshold?
    • Background
    • Methods of assessing the clinically significant threshold
    • Interpreting changes in health status measurements
    • To what do the thresholds correspond in “real life”?
    • Conclusion
    • References
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More in this TOC Section

  • Interpretation of quality of life scores from the St George's Respiratory Questionnaire
  • A national study of medical care expenditures for respiratory conditions
Show more Original Articles: COPD/Health Status

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