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

Journal of Patient-Reported Outcomes

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

Domains	Valid population (n) ^a			Observed correlation changes ^f			Hypotheses on correlations: confirmed? ^g		Observed effect size ^e			Hypotheses on effect sizes: confirmed? ^h
Domains	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

^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): ChangeT3T0_Mean/T0_SD; ^f Spearman correlation (r) between change score EQ-VAS and change score BCI and FACT-Bl-Cys (T0 and T3);
^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;
^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)