Table 4 PRO results of commonly used instruments
Study reference | Treatment/dosing regimen | Domain | Baseline score mean (SD) | Follow-up score[time, mean] | Effect size | Summary of PRO results |
|---|---|---|---|---|---|---|
Instrument: Centre for Epidemiologic Studies – Depression Scale (CES-D) | ||||||
Lake (2012) [9] | Immediate switch of PI or NNRTI to RAL (continuing prior NRTI backbone) | Depression | NR | 24 weeks, NR | N/A | ● The CES-D was administered at 0, 4, 8, 12, 18, and 24 weeks, but patient-reported depression scores were not reported in this study. |
Delayed switch (at 24 weeks) of PI or NNRTI to RAL (continuing prior NRTI backbone) | Depression | NR | 24 weeks, NR | N/A | ||
Clifford (2009) [22] | ZDV/3TC/EFV | Depression | 12.2 (10.5) | 184 weeks1, 10.1a | 0.20 | ● In participants who continued EFV-based regimens, neuropsychological performance improvement from baseline was maintained over 3 years. |
ZDV/3TC/ABC | Depression | 11.8 (10.5) | 184 weeks1, 10.4 | 0.13 | ● There was statistically significant decrease in depression symptoms over the course of the study with the median score decline of 1.0 (P = 0.03). | |
Various regimens (± EFV) | Depression | 13.3 (11.1) | 184 weeks1, 16.6 | −0.30 | ● In the long-term EFV-treated group, the percent with CES-D scores >16 declined from 34.1% to 22.3% over the duration of the study. | |
ZDV/3TC/ABC initially, then EFV added (± ABC) | Depression | 13.8 (12.5) | 184 weeks1, 8.6 | 0.42 | ||
Journot (2006) [29] | PI-based therapy | Depression2 | 23% | 48 weeks, 25% | N/A | ● Proportion of patients with depression was approximately 24% at BL and remained stable during the 48 week follow-up with no difference between treatment arms, P = 0.65). |
EFV-based therapy | Depression2 | 25% | 48 weeks, 24% | N/A | ||
36 months, 24% | N/A | |||||
● Patients with a history of depression experienced depressive symptoms more frequently than those without such history (53% and 22% at week 48, respectively; P = 0.03). | ||||||
Instrument: Functional Assessment of HIV Infection (FAHI) | ||||||
Campo (2010) [14] | Switch to EFV/3TC/ddI | Total Score | 130 | 48 weeks, 134a | N/A | ● In the overall patient population, FAHI total score increased significantly from BL to week 48 (P < 0.001) and at every other time point; changes in total score were associated with improvements in the physical and emotional well-being domains (P < 0.001 for both). |
Switch PI to EFV (continuing prior NRTIs) | Total Score | 132 | 48 weeks, 138a | N/A | ● No significant between-group differences observed. | |
Cella (2010) [15] | ETR 200 mg twice-daily3 | Total Score | 121.7 (23.7)5 | 24 weeks, 127.3a,b | 0.21 | ● The change in physical well-being, emotional well-being/living with HIV and total scores from BL to Week 24 were statistically different from zero for both groups, with statistically significant greater improvements observed in the ETR group. |
Placebo3 | Total Score | 120.9 (26.7)5 | 24 weeks, 124.0a,b | 0.11 | ||
Boyle (2008) [25] | Continue BL ARVs (BID+ dosing) | Total Score | 130.4 | 48 weeks, NR | N/A | ● A small improvement (5% or less) for the emotional well-being and a small reduction (9% or less) for functional and global well-being were observed at some time points in both arms; however, these were not considered clinically relevant, as the effect sizes were small. |
Switch to once-daily d4T/3TC/EFV | Total Score | 131.4 | 48 weeks, NR | N/A | ● No significant differences observed between arms. | |
Instrument: HIV Symptom Index / Symptom Distress Module (HIV-SI / SDM) | ||||||
Hodder (2010) [19] | EFV/FTC/TDF | Dizziness | 28% | 4 weeks, 39%a,b | N/A | ● Simplification from PI-based or NNRTI-based regimens to EFV/FTC/TDF was associated with transient worsening or emergence of dizziness and sustained improvements in several other HIV-related symptoms: diarrhea or loose bowel movements; bloating, pain or gas in the stomach, changes in body appearance, and problems having sex. |
48 weeks, 28% | N/A | |||||
Remain on BL antiretroviral regimen | Dizziness | 27% | 4 weeks, 25%b | N/A | ||
48 weeks, 28% | N/A | |||||
Potard (2010) [21] | EFV- or NVP-based therapy | Symptom Count | 11.9 (9.1) | 12 months, 9.0a | 0.32 | ● Overall, there was a small improvement in HIV symptoms at 1 year (effect size 0.32). |
Symptom Bother Count | 7.7 (5.9) | 12 months, 6.0a | 0.29 | ● An initial difference between groups in mean change in other symptoms, bothersome symptoms, and other bothersome symptoms observed at 1 month was not maintained at months 6 and 12. | ||
Regnault (2009) [18] | ZDV/3TC + MVC 300 mg twice dailyZDV/3TC + MVC 600 mg once dailyZDV/3TC + EFV 600 mg once daily | Symptom Count | Mean score ranged from ~5 (European Romance group) to ~10 (Bantu group) | 96 weeks, NR | N/A | ● This study assessed the cross-cultural validity of the HIV-SI using pre-ARV treatment cross-sectional data of the MERIT trial. |
● Statistically significant differential item functioning between cultural groups was observed for 4 items: fatigue, fevers, anxiety, and headache. | ||||||
Symptom Bother Count | Mean score ranged from 10.08 (European Romance group) to 24.00 (Bantu group) | 96 weeks, NR | N/A | ● The authors concluded that the absence of meaningful explanations for statistically significant differences between cultural groups supports the cross-cultural validity of the HIV-SI versions used in the MERIT trial. | ||
DeJesus (2008) [26] | Switch from twice-daily AZT/3TC to once-daily TDF/FTC with EFV | Symptom Count | NR | 24 weeks, NR | N/A | ● Significant differences were observed in the percentage of patients reporting the absence of the symptom at Week 24 compared to BL for 17 of the 20 items assessed. |
Symptom Bother Count | NR | 24 weeks, NR | N/A | ● Compared to BL, significantly more patients reported the absence of fatigue, absence of nausea and vomiting, absence of diarrhea, and absence of headache. | ||
Instrument: Medical Outcomes Study HIV health survey (MOS-HIV) | ||||||
Jayaweera (2009) [24] | ddI/3TC/EFV once-daily | Total Score | 874 | 96 weeks, 924 | N/A | ● The overall MOS-HIV QoL score, which is the sum of all individual MOS-HIV scores (range: 0 to 1,100), significantly improved from BL (874) to Week 96 (924; P < 0.05). |
Jayaweera (2009) [24] | d4T/3TC/EFV once-daily | Total Score | 832 | 12 weeks, 880 | N/A | ● The overall MOS-HIV QoL score significantly improved from BL (832) to Week 12 (880; P < 0.05). |
Lafaurie (2008) [28] | PI-containing regimen | PHS | 56.5 (50.0-61.8)3 | 48 weeks, -1.044 | 0.24 | ● The mean change from BL to week 48 in the PCS and MCS were −1.04 and +0.0 in the maintenance arm and −1.76 and +1.01 in the switch arm, respectively (P = 0.57 and 0.42). |
MHS | 40.2 (33.8-45.3)3 | 48 weeks, 0.004 | 0.00 | |||
EFV/ddI/FTC | PHS | 57.4 (51.5-60.4)3 | 48 weeks, -1.764 | 0.53 | ● Specific items such as physical functioning, social functioning, and emotional functioning remained unchanged in both treatment groups during follow-up. | |
MHS | 38.3 (33.4-43.6)3 | 48 weeks, 1.014 | −0.27 | |||
Bucciardini (2007) [27] | ddI/d4T/EFV | PHS | 50 (11) | 3 years, 54.9 | −0.45 | ● Similar results reported for follow-up at years 1 and 2 (data not shown). |
MHS | 49 (10) | 3 years, 49.5 | −0.05 | |||
ddI/d4T/NFV | PHS | 46 (13) | 3 years, 50.9 | −0.38 | ● During follow-up, an increase of PHS score was observed in all treatment arms (NS). | |
MHS | 48 (10) | 3 years, 53.5 | −0.55 | |||
ddI/d4T/EFV/NFV | PHS | 48 (12) | 3 years, 50.0 | −0.17 | ● The MHS score of both NNRTI- and PI-based 3-drug regimens showed a trend toward improvement but remained substantially unchanged with the four-drug combination. | |
MHS | 50 (9) | 3 years, 53.4 | −0.38 | |||
Portsmouth (2005) [30] | Continue twice-daily regimen of d4T(IR)/3TC/EFV or ZDV/3TC/EFV | Total Score | NR | 24 weeks, NR | N/A | ● There were no significant differences in quality of life between the IR and PRC arms based on overall (sum of 11 domains) change from BL to week 24. |
Cognitive Function | NR | 24 weeks, NRa | N/A | ● Both arms showed significant improvement in the cognitive function domain (P < 0.001) during the course of the study, based on BL cognitive scores at weeks 12 and 24. | ||
Switch to once-daily d4T(PRC)/3TC/EFV | Total Score | NR | 24 weeks, NR | N/A | ● Differences between groups were not observed. | |
Cognitive Function | NR | 24 weeks, NRa | N/A | |||
Casado (2004) [31] | ZDV/3TC/NFV | PHS | 54.16 (8.97) | 12 months, 52.79 | −0.15 | ● In the ZDV/3TC/NVP arm, there were statistically significant changes in the PHS score (P < 0.01) and a trend toward statistically significant change in the MHS score (P = 0.07). |
MHS | 45.72 (11.10) | 12 months, 49.20 | 0.31 | |||
ZDV/3TC/NVP | PHS | 50.95 (11.37) | 12 months, 56.73a | 0.51 | ||
MHS | 43.78 (9.92) | 12 months, 48.22 | 0.45 | ● There were no statistically significant changes over time in the ZDV/3TC/NFV arm in both summary scores. | ||
Negredo (2004) [32] | Continue twice-daily ARV therapy (PI- or NNRTI-based) | General Health | NR | NR | N/A | ● Although quality of life tended to increase in both groups, no significant differences were found during the study in general health and health transition scales. |
Health Transition | NR | NR | N/A | |||
Switch to once-daily ddI/TDF/NVP | General Health | NR | NR | N/A | ||
Health Transition | NR | NR | N/A | |||
van Leth (2004) [33] | d4T/3TC/EFV | PHS | 50.5 | 48 weeks, 53.9 | N/A | ● PHS and MHS BL values were comparable in all 3 treatment groups (P = 0.883 and P = 0.937, respectively). |
MHS | 46.9 | 48 weeks, 53.9 | N/A | |||
d4T/3TC/NVP | PHS | 51.0 | 48 weeks, 54.9 | N/A | ● No significant differences between the 3 treatment groups in increases in dimension scores. | |
MHS | 46.7 | 48 weeks, 52.8 | N/A | ● After adjusting for all significantly associated variables, the increase of PHS was 4.6 for NVP, 4.8 for EFV and 3.8 for NVP + EFV (P = 0.790); the adjusted increase of MHS was 6.1, 7.3 and 3.8, respectively (P = 0.093). | ||
d4T/3TC/EFV/NVP | PHS | 50.9 | 48 weeks, 53.8 | N/A | ||
MHS | 47.1 | 48 weeks, 51.0 | N/A | |||