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Inflammatory bowel diseases (IBDs) are chronic disabling conditions, characterized by an unpredictable course with flare-ups and periods of remission, that frequently affect young people and require lifelong medical follow-up and treatment. For years, the main endpoints of IBD treatment had been clinical remission and response, followed by biomarker normalization and mucosal healing. In the last decades, different therapies have been proved to be effective to treat IBD and the use of patient reported outcome (PRO) have become more relevant. Therefore, health-related quality of life (HRQoL) that has been defined as the value assigned to the duration of life influenced by physical and mental health, has been suggested as an important endpoint for IBD management since multiple studies have shown that IBD impairs it, both physically and psychologically.
Target |
Recall Period |
Number of Items |
Response Options |
Range of Scores (Worst-Best) |
Reliability |
||
---|---|---|---|---|---|---|---|
Specific-disease tools |
IBDQ-32 |
IBD |
2 weeks |
32 |
7-Level Likert (1–7) |
32–224 |
+++ |
SIBDQ |
IBD |
2 weeks |
10 |
7-Level Likert (1–7) |
10–70 |
++ |
|
IBDQ-36 |
IBD |
2 weeks |
36 |
7-Level Likert (1–7) |
36–252 |
NA |
|
IBDQ-9 |
IBD |
2 weeks |
9 |
7-Level Likert (1–7) |
0–100 |
++ |
|
CUCQ-8 |
IBD |
2 weeks |
8 |
4-Level Likert (0–3) or ordinal format (0–14) |
90–0 |
+++ |
|
CLIQ |
CD |
Today |
27 |
True/Not true (1–0) |
27–0 |
+++ |
|
IBDQ-D |
UC-IPAA |
2 weeks |
32 |
7-Level Likert (1–7) |
32–224 |
NA |
|
CAF-QoL |
CD |
6–8 weeks |
28 |
4-Level Likert (0–4) |
112–0 |
+++ |
|
Generic tools |
SF-36 |
Patients and general population |
4 weeks |
36 |
Linear transformation of raw scores |
0–100 |
+++ |
EQ-5D |
Patients and general population |
Today |
6 |
|
243 health status, index 0–1
|
+++ |
Treatment |
Study |
Measurement Tool(s) |
No. Patients |
HRQoL: Primary Outcome |
Results |
---|---|---|---|---|---|
5-ASA |
Robinson et al. [27] |
5 disease-specific and 7 general items |
374 UC |
Yes |
Mesalamine 2 g and 4 g daily was significantly superior to placebo in improving each of the 12 HRQoL parameters. |
Probert et al. [28] |
EQ-5D-3L |
115 UC |
No |
The combined (oral + rectal) therapy group reported a significant improvement in the ‘mobility’, ‘usual activity’ and ‘anxiety/depression’ domains at week 4. |
|
Thiopurines |
Alruthia et al. [29] |
EQ-5D-3L EQ-5D-VAS |
160 IBD (56% CD, 44% UC) |
Yes |
Patients on AZA presented higher HRQoL at six-month follow-up compared with patients on other treatments (β = 9.35; 95% CI: 0.486–18.22; p = 0.003). |
Bastida et al. [30] |
SF-36 IBDQ |
92 IBD (68 CD, 24 UC) |
Yes |
Compared with baseline, 68 and 64% patients’ scores improved at 6 and 12 months, respectively (ΔIBDQ was 0.86 and 1.05, respectively). SF-36 showed a similar improvement. |
|
Calvet et al. [31] |
SF-36 |
33 RCD a, 14 ACD b, 66 HC c |
Yes |
SF-36 were 85 in RCD, 85 in HC (p = 1), and 58.6 in ACD (p < 0.001 for comparison with RCD and HC). |
|
Infliximab |
Feagan et al. [32] |
IBDQ SF-36 |
728 UC |
No |
IBDQ score improvement was significantly greater in the IFX 5 and 10 mg/kg groups (40 and 36, respectively p < 0.001) vs. placebo (28). |
Silva et al. [33] |
IBDQ |
31 UC |
Yes |
In IFX group (n = 21), the IBDQ scores ranges from 116.2 at baseline to 170.75 and 176.62 at week 30 and 54, respectively (p ≤ 0.02) |
|
Feagan et al. [34] |
IBDQ SF-36 |
335 CD |
No |
The mean change in the IBDQ at week 54 compared to baseline was 22.1 in the 5 mg/kg and 30.2 in 10 mg/kg IFX maintenance group while it was 8.9 in the placebo group (p ≤ 0.05). SF-36 changed in the same line. |
|
Adalimumab |
Travis et al. [35] |
SIBDQ EQ-5D-5L EQ-5D-VAS |
463 UC |
Yes |
Significant improvements from baseline to week 26 were detected on SIBDQ (mean change 17.4) and EQ5D (index: 0.1 ± 0.2; VAS: 19.5). |
Louis et al. [36] |
SIBDQ |
945 CD |
No |
60% of IFX-naïve patients and 47% of IFX primary non-responders reported clinically significant improvements (≥9 points) on SIBDQ. |
|
Saro et al. [37] |
IBDQ EQ-5D EQ-5D-VAS |
126 CD |
Yes |
It has been shown a significant improvement on the EQ5D from 0.735 to 0.797, the EQ5D VAS from 50.0 to 80.0, and the IBDQ from 56.7 to 67.5 (p < 0.05 for all comparisons). |
|
Golimumab |
Feagan et al. [38] |
IBDQ SF-36 |
1064 UC |
No |
It was determined a significantly greater improvement from baseline to week 6 in GLM vs. placebo groups in IBDQ (27.2 vs. 14.6), SF-36 PCS (4.14 vs. 2.46) and MCS (4.89 vs. 1.60, p < 0.01 for all comparisons). |
Vedolizumab |
Feagan et al. [39] |
IBDQ SF-36 EQ-5D-3L ED-5D-VAS |
373 UC |
No |
Patients on VDZ reported significantly greater improvements in IBDQ and EQ5D-VAS scores. For EQ-5D utility score, only the VDZ every 4 weeks group showed a significant difference from placebo. At week 52, more patients on VDZ met the minimal clinically meaningful difference thresholds for IBDQ, SF-36 physical component and EQ5D-VAS scores. |
Loftus et al. [40] |
IBDQ |
769 UC (383 VDZ, 386 ADA) |
No |
At week 52, clinically important IBDQ improvement was detected in a greater proportion of VDZ treated patients compared with ADA treated ones (52.0% vs. 42.2%). Likewise, 50.1% (VDZ) vs. 40.4% (ADA) of patients achieved IBDQ remission. |
|
Vermiere et al. [41] |
IBDQ EQ5D-VAS SF-36 |
1349 CD |
No |
At week 80, the mean changes from baseline HRQL scores were >51 for IBDQ, >23 for EQ-5D VAS, >9 for SF-36 PCS and >10 for SF-36 MCS. |
|
Parkes et al. [42] |
SIBDQ |
61 IBD (21 CD, 40 UC) |
No |
SIBDQ score increased by 8.5 and 10.2 points in CD and UC patients, respectively, at week 14. |
|
Eriksson et al. [43] |
SHS |
169 CD |
No |
It has been seen a significant decreased of the SHS score at week 52 (n = 68; p < 0.001) |
|
Ustekinumab |
Sandborn et al. [44] |
IBDQ SF-36 |
284 UC |
No |
55.6% of patients who had been treated with USK were in IBDQ remission. Regarding the SF-36, 50.0% and 45.1% of patients had a clinically meaningful improvement in the PCS and the MCS, respectively. |
Sands et al. [45] |
IBDQ SF-36 |
1368 CD |
No |
A clinically meaningful improvement in IBDQ score at week 8 was achieved in 68.1% of anti-TNF naïve patients and 54.8% of patients with previous failure to antiTNF. Similarly, greater improvements in SF-36 in the USK group have been determined. |
|
Marquès et al. [46] |
IBDQ |
33 CD |
Yes |
18% achieved IBDQ normalization at week 52. |
|
Tofacitinib |
Panés et al. [47] |
IBDQ SF-36 |
1161 UC (induction) 593 UC (sustain) |
No |
In OCTAVE induction 1 and 2, mean IBDQ changes from baseline to week 8 was 40.7 and 44.6 with TFC 10mg twice daily versus 21 and 25 with placebo, respectively (p < 0.001). Mean SF-36 changes were comparable with the IBDQ changes and both were sustained at week 52 |
Surgery (intestinal resection) |
Wright et al. [48] |
IBDQ SF-36 |
174 CD |
No |
A significant improvement has been observed at 6 months postoperatively compared to preoperatively in PCS (68 vs. 40), MCS (68 vs. 44) and IBDQ (171 vs. 125; p < 0.001 for all comparisons). |
Ha et al. [49] |
5 generic tools 3 disease-specific tools |
1108 CD |
Yes |
Both generic and disease-specific tools showed an improvement in HRQoL from 2 weeks after intestinal resection for up to 5 years. |
AZA: azathioprine. IFX: infliximab. GLM: golimumab. VDZ: vedolizumab. ADA: adalimumab. USK: ustekinumab. TFC: tofacitinib.a Remission Crohn’s disease. b Active Crohn’s disease. c Healthy controls.