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Table 7 Responsiveness properties of the BCI and FACT-Bl-Cys

From: Translation and validation of two disease-specific patient-reported outcome measures (Bladder Cancer Index and FACT-Bl-Cys) in Dutch bladder cancer patients

Domains Valid population (n) a Observed correlation changes f Hypotheses on correlations: confirmed? g Observed effect size e Hypotheses on effect sizes: confirmed? h
EQ-VAS no change group b EQ-VAS improved group c EQ-VAS deteriorated group d EQ-VAS no change group b EQ-VAS improved group c EQ-VAS deteriorated group d EQ-VAS improved group c EQ-VAS deteriorated group d EQ-VAS no change group b EQ-VAS improved group c EQ-VAS deteriorated group d EQ-VAS improved group c EQ-VAS deteriorated group d
EQ-VAS 68 55 89 1.00 1.00 1.00 NA. NA. 0.00 1.32 −2.94 NA. NA.
BCI
 Urinary domain 55 42 32 0.10 0.17 −0.12 No No 0.06 0.36 −0.44 Yes Yes
 Function 51 43 29 0.00 −0.13 − 0.19 No No −0.45 − 0.44 − 0.56 No Yes
 Bother 52 38 31 0.04 0.29 −0.05 No No 0.35 0.35 −0.05 No No
 Bowel domain 57 47 40 0.32 0.42 0.11 Yes No −0.90 −0.06 −0.44 No No
 Function 53 46 38 0.24 0.25 −0.18 No No −0.43 0.05 −0.36 No No
 Bother 57 47 39 0.29 0.39 0.18 Yes No −0.75 −0.11 −0.42 No No
 Sexual domain 15 20 10 −0.01 0.23 −0.14 No No −0.85 −0.50 −1.10 No Yes
 Function 14 17 12 0.01 0.25 −0.36 No Yes −0.68 −0.48 −1.25 No No
 Bother 43 34 28 0.06 0.04 0.28 No No −0.35 −0.29 −0.72 No No
FACT-Bl-Cys
 FACT-PWB 66 52 42 0.54 0.51 0.44 Yes Yes 0.00 0.80 −0.40 Yes Yes
 FACT-SWB 65 52 41 0.26 0.20 0.24 No No −0.50 −0.17 0.00 No No
 FACT-EWB 61 49 40 0.30 0.40 0.38 Yes Yes 0.60 0.80 0.25 Yes No
 FACT-FWB 64 51 40 0.42 0.47 0.31 Yes Yes 0.20 0.67 −0.40 Yes Yes
 Bl-Cys domain 64 50 41 0.13 0.44 0.42 Yes Yes 0.22 0.55 −0.22 Yes Yes
 FACT-Bl-Cys total 59 45 40 0.39 0.62 0.53 Yes Yes 0.17 0.75 −0.18 Yes Yes
  1. a The number of patients that completed enough items to calculate a total score; b No change between T0 and T3 for patients in EQ-VAS score (plus or minus ≤5 points); c Change between T0 and T3 for patients with an improved EQ-VAS score of ≥10 points; d Change between T0 and T3 for patients with a deteriorated EQ-VAS score of ≥10 points; e Formula assessed for Effect Size (Cohens d): ChangeT3T0Mean/T0SD; f Spearman correlation (r) between change score EQ-VAS and change score BCI and FACT-Bl-Cys (T0 and T3);
  2. g Hypotheses correlations = in patients with an improved or declined EQ-VAS score (≥10 points), we hypothesized to find moderate correlations of ≥0.30 between change in EQ-VAS and the change in BCI and FACT-Bl-Cys values;
  3. h Hypotheses effect sizes = in patients with an improved or declined EQ-VAS score (≥10 points), we hypothesized to find a larger effect size, in comparison to patients that did not show a change in EQ-VAS (≤5 points)
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