| Clinical question: Should early palliative care be preferred over treatment as usual for improving health‐related quality of life, depression, and symptom intensity in patients with advanced cancer? |
| Patient or population: patients with advanced cancer Settings: mainly outpatient care in Australia, Canada, Italy, and the USA
Intervention: early palliative care Comparison: treatment as usual Follow‐up: at 12 weeks or mean difference in repeated measurement results for longitudinal designs |
| Health‐related quality of life (HRQOL), SD units: measured on FACIT‐Pal, TOI of FACT‐Hep, TOI of FACT‐L, FACT‐G, McGill Quality of Life, FACIT‐Sp. Higher scores indicate better HRQOL. Follow‐up: range 12 weeks to 52 weeks | HRQOL score improved on average 0.27 (95% CI 0.15 to 0.38) SDs more in early palliative care participants than in control participants | ‐ | 1028
(7 RCTs) | ⊕⊕⊝⊝
LOW1,2,3 | By conventional criteria, an SMD of 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect (Cohen 1988) |
| Health‐related quality of life (HRQOL), natural units: measured on FACT‐G (from 0 to 108) | Baseline control group mean score at 70.5 pointsa | HRQOL score improved on average 4.59 (95% CI 2.55 to 6.46) points more in early palliative care participants than in control participants | ‐ | 1028
(7 RCTs) | ⊕⊕⊝⊝
LOW1,2,3 | Calculated by transforming all scales to the FACT‐G in which the minimal clinically important difference is approximately 5 and the SD in the cancer validation sample was 17.0 (Brucker 2005) |
| Survival: estimated with the unadjusted death hazard ratio | Study populationb | HR 0.85, 95% CI 0.56 to 1.28 | 800
(4 RCTs) | ⊕⊝⊝⊝
VERY LOW1,4,5,6 | |
| 61 per 100 | 56 per 100 (41‐71) |
| Depression, SD units: measured on CES‐D, HADS‐D, PHQ‐9. Higher scores indicate higher depressive symptom load. Follow‐up: range 12 weeks to 52 weeks | Depression score improved on average ‐0.11 (95% CI ‐0.26 to 0.03) SDs more in early palliative care participants than in control participants | ‐ | 762
(5 RCTs) | ⊕⊝⊝⊝ VERY LOW1,2,4 | By conventional criteria, an SMD of 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect (Cohen 1988) |
| Depression, natural units: measured on CES‐D (from 0 to 60). Higher scores indicate higher depressive symptom load | Baseline control group mean score at 13.8 pointsc | Depressive symptoms score improved on average ‐0.98 (95% CI ‐2.31 to 0.27) points more in early palliative care participants than in control participants | ‐ | 762
(5 RCTs) | ⊕⊝⊝⊝ VERY LOW1,2,4 | Calculated by transforming all scales to CES‐D and applying an SD of 8.9 from baseline control group score in Bakitas 2009 |
| Symptom intensity, SD units: measured on ESAS, QUAL‐E Symptom Impact Subscale, SDS, RSC, LCS of FACT‐L, HCS of FACT‐Hep. Higher scores indicate higher symptom intensity. Follow‐up: range 12 weeks to 52 weeks | Symptom intensity score improved on average ‐0.23 (95% CI ‐0.35 to ‐0.1) SDs more in early palliative care participants than in control participants | ‐ | 1054
(7 RCTs) | ⊕⊕⊝⊝
LOW1,2,3 | By conventional criteria, an SMD of 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect (Cohen 1988) |
| Symptom intensity, natural units: measured on ESAS (from 0 to 900). Follow‐up: range 12 weeks to 52 weeks | Baseline control group mean score at 286.3 pointsc | Symptom intensity symptoms score improved on average ‐35.4 (95% CI ‐53.9 to ‐15.4) points more in early palliative care participants than in control participants | ‐ | 1054
(7 RCTs) | ⊕⊕⊝⊝
LOW1,2,3 | Calculated by transforming all scales to the ESAS and applying an SD of 154.0 from baseline control group score in Bakitas 2009 |
| Adverse events | See comment | See comment | Not estimable | 1614
(7 RCTs) | See comment | Most often, study authors did not address assessment or findings on adverse events in their study publications. However, on request, authors of 6 studies described the tolerability of early palliative care as very good. A single study mentioned adverse events only in the early palliative care group, i.e. higher percentage of participants with severe scores for pain and poor appetite along with higher level of unmet needs (Tattersall 2014) |
| *Risk in the intervention group (and its 95% confidence interval) is based on assumed risk in the comparison group and relative effect of the intervention (and its 95% CI) aApproximate average of baseline control group FACT‐G scores across 4 included studies (Bakitas 2009; Bakitas 2015; Maltoni 2016; Temel 2010) b12‐Month follow‐up control group risk in the largest study reporting on survival (Bakitas 2009) cBaseline control group CES‐D score in the largest study reporting on depression (Bakitas 2009) CI: confidence interval; GRADE: Grading of Recommendations Assessment; HR: unadjusted death hazard ratio; SD: standard deviation; SMD: standardised mean difference |
| GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect.
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect. |
