Tables
- TABLE 1
Change in measures that met responsiveness criteria over 24 weeks by health transition question (SF2) categorical responses in patients with idiopathic pulmonary fibrosis in the Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis (STEP-IPF) trial
SF2 response at 24-week follow-up AUC (95% CI)¶ Much better Somewhat better About the same Somewhat worse# Much worse Subjects n 7 12 46 58 9 Physiological measures Δ6MWD m −3.71±42.33 −35.08±144.51 −32.29±95.46 −74.89±69.32 −163.00±122.93 0.72 (0.61–0.83) Data are presented as mean±sd, unless otherwise stated. AUC: area under the curve; Δ: absolute change over 24 weeks; 6MWD: 6-min walk distance. #: the mean change in scores in the “somewhat worse” category is the minimal clinically important difference value for measures that meet the responsiveness criteria; ¶: receiver operating curve comparing dichotomous health transition question (SF2) response (“about the same” versus “somewhat worse”) with mean change score of variable.
- TABLE 2
Change in measures that met responsiveness criteria over 60 weeks by health transition question (SF2) categorical responses in patients with idiopathic pulmonary fibrosis in the Prednisone, Azathioprine, and N-Acetylcysteine: A Study That Evaluates Response in Idiopathic Pulmonary Fibrosis (PANTHER-IPF) trial
SF2 response at 60-week follow-up AUC (95% CI)¶ Much better Somewhat better About the same Somewhat worse# Much worse Subjects n 11 32 101 74 10 Physiological measures ΔSF-36 physical component score+ 8.00±11.57 −0.92±6.26 −0.06±5.72 −6.79±8.07 −5.29±9.26 0.75 (0.67–0.83) Subjective measures ΔTotal SGRQ score§ −13.70±14.55 −0.97±9.60 1.35±9.18 10.95±13.19 25.86±17.46 0.71 (0.63–0.79) ΔUCSD SOBQ total score −4.45±11.79 3.19±9.60 0.59±12.81 11.38±15.31 34.90±23.65 0.72 (0.65–0.80) Data are presented as mean±sd, unless otherwise stated. AUC: area under the curve; Δ: absolute change over 60 weeks; SF-36: 36-Item Short-Form Health Survey; SGRQ: St George's Respiratory Questionnaire; UCSD SOBQ: University of California, San Diego Shortness of Breath Questionnaire. #: the mean change in scores in the “somewhat worse” category is the minimal clinically important difference value for measures that meet the responsiveness criteria; ¶: receiver operating curve comparing dichotomous health transition question (SF2) response (“about the same” versus “somewhat worse”) with mean change score of variable; +: missing n=5 (0 “much better”, 1 “somewhat better”, 4 “about the same”, 0 “somewhat worse”, 0 “much worse”); §: missing n=13 (0 “much better”, 2 “somewhat better”, 8 “about the same”, 3 “somewhat worse”, 0 “much worse”).
- TABLE 3
Anchor-based estimates of minimal clinically important difference (MCID) for worsening in idiopathic pulmonary fibrosis from current study and comparison with MCID estimates from previous studies
Current MCID estimate Previous MCID estimate# Time period¶ MCID+ (95% CI) Time period [ref.] MCID 6MWD m 24 weeks −74.89 (−93.11– −56.66) 48 weeks [14] 24–45§ 48 weeks [16] 21.7 –37.0§ 52 weeks [11] 28 SF-36 physical component score 60 weeks −6.79 (−8.66– −4.92) 26 weeks [13] 3 No specified time period [10] 5 Total SGRQ score 60 weeks 10.95 (7.81–14.1) 26 weeks [13] 7 (5–10)## 52 weeks [12] 4–5 UCSD SOBQ total score 60 weeks 11.38 (7.83–14.93) 24 weeks [19] 8 (5–11)## 6MWD: 6-min walk distance; SF-36: 36-Item Short-Form Health Survey; SGRQ: St George's Respiratory Questionnaire; UCSD SOBQ: University of California, San Diego Shortness of Breath Questionnaire. #: previous studies have estimated MCID values for worsening and improvement using both anchor-based and distribution-based methods; ¶: 6MWD met responsiveness criteria only in the Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis (STEP-IPF) cohort, while the SF-36 physical component score, SGRQ and UCSD SOBQ met criteria in only the Prednisone, Azathioprine, and N-Acetylcysteine: A Study That Evaluates Response in Idiopathic Pulmonary Fibrosis (PANTHER-IPF) cohort; therefore, time period for MCID is 24 weeks or 60 weeks; +: MCID for worsening only, since it was calculated as mean change in “somewhat worse” health transition question (SF2) group from baseline to follow-up; §: range; ##: point estimate (range).
Supplementary Materials
Supplementary Material
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Supplementary material 00142-2021.SUPPLEMENT
