Background
Objective
Methods
Inclusion and exclusion criteria
CHC PRO concept search | CHC trials with PRO endpoints search | PRO measure search | |
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Search Specific Inclusion Criteria
| CHC and over 16 years of age | CHC and over 16 years of age | CHC and over 16 years of age |
Search Specific Inclusion Criteria
| 1999-2009 | 1994-2009 | 1999-2009 |
Search Specific Inclusion Criteria
| Review article, qualitative research or article discussing concepts relevant to CHC disease or treatment. | · RCTs or non-randomized trials. | · Reported on the development/ validation of a PRO instrument or one of the concepts of interest selected during the CHC PRO Concept Search. |
· Patients in at least one arm must have received pegylated interferon. | |||
· Follow-up duration of at least 48 weeks. | · PRO instrument designed for use in CHC population or used in CHC population; if no PROs available for a particular concept of interest additional methods were utilized. | ||
· PRO data must have been reported in a manner that allowed for determination of differentiation between treatments over time. |
Databases
Key search terms and screening process
Results
Findings from PRO concept search
PRO endpoint results from CHC trials
Citation | Study Design and Treatment | Study Population | PRO Instruments | PRO Domains Assessed | PRO results |
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Arora et al[33] | - Randomized, open-label, parallel group, controlled trial | CHC patients | - SF-36 | -HRQL | Patients with an SVR had better SF-36 and FSS scores than both virological non-responders and patients in the untreated control group at the end of follow-up (week 72; Table 2). In patients who received combination therapy (groups A and B combined), the differences in mean HRQL scores between patients with an SVR and virological non-responders were statistically significant for five of eight SF-36 domains (General Health, P < 0.0001; Bodily Pain Index, P < 0.0001; Role Physical, P < 0.05; Physical Functioning, P < 0.05; Vitality, P < 0.0001) and the Physical Health component score, P < 0.0001 (Table 2). Consistent with these findings, both the FSS Total score (P < 0.01 vs. non-responders) and VAS score (P < 0.01 vs. non-responders) were significantly better in patients with an SVR. |
N = 491 | - FSS | -Impact and severity of fatigue on HRQL | |||
- Group A = 24 weeks; | Prior therapy: Patients had not received prior treatment for CHC. | ||||
Group B = 48 weeks; | |||||
No treatment = 72 weeks | |||||
-Pegylated interferon alpha 2a + ribavarin | |||||
Bernstein et al.[3] | - Open-label RCT | CHC patients | - SF-36 | -Physical function, role limitations physical, vitality, general health perceptions, pain, social function, role limitations-emotional, mental health. | (Results using ANCOVA) |
-Fatigue | |||||
- 72 weeks | N = 676 | - FSS | 'Virologic response associated with positive HRQL changes in all domains on FSS and SF-36 | ||
-Pegylated interferon alpha-2a; unmodified interferon-2a | |||||
Prior therapy: none | - Patients taking peginterferon reported better HRQOL and less fatigue than interferon in all FSS domains, and 7/8 of SF-36 domains (exception Physical Function). | ||||
Hassanein et al[34] | - Open-label RCT | CHC patients | - SF-36 | -Physical function, role limitations physical, vitality, general health perceptions, pain, social function, role limitations-emotional, mental health | (Results using ANCOVA) |
- 72 weeks | N = 1121 | - FSS | - Using the SF-36, the addition of ribavarin to peginterferon increased HRQOL in domains of physical function, role limitations, vitality, social functioning, mental health (not bodily pain, general health, role limitations emotional). | ||
-Peginterferon alfa-2a +placebo; Peginterferon alfa-2a + ribavarin; Interferon alfa2b + ribavarin | |||||
Prior therapy: None | |||||
- Using the FSS, the addition of ribavarin to peginterferon increased HRQOL in domains of total fatigue and fatigue severity. | |||||
-Fatigue | |||||
- Using the SF36, peginterferon (with ribavarin) as compared to interferon (with ribavarin) increased HRQOL in domains of role limitations physical, bodily pain, vitality, social functioning (not physical function, general health, role limitations emotional, and mental health). | |||||
- Using the FSS, peginterferon (with ribavarin) as compared to interferon (with ribavarin) increased HRQL in domains total fatigue and fatigue severity. | |||||
Nayman Alpat et al.[35] | - Non-randomized trial | CHC patients | - SF-36 | -Physical function, role limitations physical, vitality, general health perceptions, pain, social function, role limitations-emotional, mental health | Use of the Mann Whitney U test revealed no significant differences between the treatment groups on any of the domains. |
N = 40 | |||||
- 72 weeks | Prior therapy: Not Reported | ||||
-Peginterferon alfa-2a +ribavirin; Peginterferon alfa-2b +ribavirin | |||||
Neri et al.[38] | - Randomized, open-label, prospective trial | HCV patients | - HAM-D | Depression | Logistic regression analysis showed in both groups a significant trend from baseline according to the ZSRDS (odds ratio 0.698, p < 0.01 [95% CI 0.59, 0.78]) to predict early major depressive disorders confirmed by the study. |
N = 186 | - ZSRDS | ||||
Prior therapy: Not Reported | |||||
- Follow-up once a month for 48 weeks of treatment and 4 and 8 weeks after the end of therapy | - SCID | ||||
-Pegylated interferon alpha 2a; Pegylated interferon alpha 2b | |||||
Perrillo et al.[37] | - Open-label RCT | CHC patients | - HQLQ | - HQLQ: social function, role limitations emotional, vitality, general mental health, physical function, role limitations physical, freedom from pain, general health, health distress, positive well-being, hepatitis-specific limitations, hepatitis-specific health, PCS, MCS. | ANCOVA was used to test differences in change scores between treatment groups. |
- 72 weeks | N = 412 | - WPAI | |||
-Peginterferon alfa-2&z.ausco;; Interferon alfa-2b + ribavirin | Prior therapy: None | ||||
- HRQL as measured on all domains diminished during treatment for both treatment groups. | |||||
- For all SF-36 scales, however, the peginterferon alfa-2a group experienced less impairment than did the interferon alfa-2 b group. | |||||
- The between-treatment differences were significant in 3 of the scales at week 48. | |||||
-WPAI: impact of therapies on work productivity, health care utilization | |||||
Rasenack et al.[36] | - Open-label, randomized, parallel-dose study | CHC patients | - FSS | - HRQL | -FSS- Statistically significant differences between treatment groups favoring peginterferon α-2a were seen in FSS total scores at weeks 2, 12, and 24 and in FSS VAS scores at weeks 2 and 12 (p < 0.01). |
N = 531 | - SF-36 | - Fatigue | |||
Prior therapy: None | |||||
- 72 weeks | |||||
-SF-36- peginterferon α-2a patients demonstrated significantly better mean scores in all eight SF-36 domains (p < 0.01 to p < 0.05) compared with those treated with unmodified interferon α-2a. | |||||
-Peginterferon α-2a (40kD); Unmodified interferon α-2a |
Depression and anxiety | Fatigue | Flu-like symptoms | Cognitive function | Insomnia | CHC-specific measures |
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BDI and revised BDI-II | FIS | Flu-iiQ | MOS-Cog | ESS | CLDQ1 |
BAI | FSS1 | FIQ | MOS-SS | PSQI | CLDQ-HCV1 |
HADS | MAF | PROMIS Sleep Disturbance Subscale | HQLQ1 | ||
CES-D | PROMIS Fatigue Subscale | ||||
ZSRDS | |||||
PROMIS Depression Subscale |