OP-19 A study into the benefit of ‘standard palliative care’ on symptom control in randomised controlled trials

<h3>Background</h3> Measuring and assessing the impact of palliative care is a challenge faced by researchers and clinicians. Despite established standards, assessing the benefit of palliative care remains challenging due to its subjective nature, diverse care models and frailty of patients. This study evaluates the benefit of palliative care, when delivered within a standard approach in the context of randomised controlled trials (RCTs), by assessing its impact on symptoms and quality of life using the change in Total Symptom Distress Score (TSDS) of the Edmonton Symptom Assessment Scale (ESAS) as an indicator of improvement. <h3>Objective</h3> The primary objective was to determine if standard palliative care delivered within a RCT led to an improvement in TSDS that was either statistically and/or clinically significant. <h3>Methods</h3> A literature review identified five RCTs conducted on patients actively receiving palliative care, with ESAS measured on two occasions within a 4-week period. A meta-analysis was conducted to look at the Mean Differences (MD) and Standardized Mean Differences (SMD) in TSDS in the identified RCTs. The magnitude in reduction of TSDS can be determined to be clinically relevant by considering the Minimal Clinically Important Difference (MCID). Based on work by Hui et al., an improvement of at least 5.7 was considered to be clinically significant. <h3>Results</h3> The five trials included 274 patients receiving palliative care in the United States of America, Australia, and Poland. All trials involved patients with advanced cancer. The analysis found a statistically significant improvement in the TSDS of the palliative care arms over a 2- 4-week period. The SMD of the TSDS showed statistically significant improvement at Day 14 (SMD -0.59, 95% CI: -0.84, -0.34), as well as at Day 28 (SMD -0.49, 95% CI: -0.75, -0.22) when compared to baseline. The MD analysis supported these findings, with statistically significant improvement at Day 14 (MD -5.80, 95% CI: -8.53, -3.07), and at Day 28 (MD -6.64, 95% CI: -11.27, -2.01). Standard palliative care was also found to deliver clinically significant improvements in TSDS in these RCTs. <h3>Discussion</h3> The results of the meta-analysis provide evidence of the benefits of palliative care in improving patient outcomes over a 2–4-week period in a RCT setting. Our findings replicate evidence that participation in RCTs may be beneficial compared to non-participation. A review of the examined trials however, noted a heterogeneity in the definition of ‘standard palliative care’. This study therefore observes that the results might not be replicable in standard practice outside of RCTs. The intensity of patient contact in the RCTs analysed here exceeds the frequency of contact in published studies of ‘real world’ palliative care, which could contribute to the improvement in symptoms observed in this paper. Future trials should aim to clearly define the standard of palliative care applied. This would render RCTs more useful to clinicians who are looking to integrate trial findings into real-world palliative care models.