HNA data and EQ-5D results at baseline and follow-up were obtained for 349 individuals as not every client opts to have a HNA or has a Review (as of August 2019, approximately 6800 clients were referred to ICJ, with approx. 4100 or 60% of referrals completing a HNA, and approx. 1800 or 43% of HNAs also receiving a follow-up HNA). As detailed in Figure 2, twelve participants were excluded for not having had any concerns recorded at HNA or review, four participants were removed for having baseline and follow-up scores recorded less than 14 days apart, one participant was removed for reporting an unusually large number of concerns in their HNA, and one participant was removed for having an incomplete EQ5D. A total of 331 individuals were analysed. The time between assessments ranged from 14 to 456 days, averaging 117 days (median 84). Between baseline and follow up, self reported severity of concern dropped, in line with previous findings [9]. Figure 3 shows the mean change in the different domains of the HNA. There is further detail in supplementary file 1.
Figure 3 Baseline, Follow-up and Change score for Mean concern severity across domains. Error bars depict 95% CI. The negative change scores correspond to an improvement.
Table 2 shows patient characteristics. In summary, the majority of participants were aged between 50-64 years, 59% were female, most resided in areas of high deprivation and cancer type and stage were varied. The variable ‘Palliative care’ denotes individuals who identified as receiving palliative care at baseline or follow-up.
Table 2. Patient characteristics
Primary Hypothesis
- There will be a statistically significant difference between EQ-5D scores at baseline and EQ-5D scores post intervention.
Table 3 presents the descriptives of the EQ-5D-3L Utility score and Visual Analogues Scale (VAS) at baseline and follow-up. Figure 4 shows the same data but for each individual participant in spaghetti plots. Both EQ-5D measures increased, indicating an improvement in health status. The distributions of change scores for EQ-5D utility scores and VAS were approximately normal with heavier tails on the positive side, and a large proportion of 0 values. However, because the sample size was sufficiently large, the t-test was assumed to be sufficiently robust to non-normality (Lund & Lund, 2019).
Table 3. Descriptive summary of outcomes. The negative difference in concern severity is interpreted as an improvement.
Using a paired t-test, the increase in EQ-5D utility scores of 0.121 [0.0891-0.153] at follow-up was found to be statistically significant (p<.001), as was the increase in VAS of 7.81 [5.88-9.74] (p<.001). Cohen’s d effect sizes were 0.43 [0.27-0.58] for Utility score difference, and 0.42 [0.27-0.58] for VAS, both of which are considered small to moderate. The hypothesis of a significant difference between baseline and follow-up on EQ-5D scores was supported. The mean changes in EQ-5D scores fell within previously published Minimal Clinically Important Difference (MCID) estimates for oncological patients: 0.07 to 0.12 for utility scores[20], and 7 to 12 for VAS [21]. Table 4 shows the estimated proportion of individuals who had a clinically important improvement or decline using the reported MCID values as lower and upper bounds.
Table 4. Proportion of individuals whose EQ5D scores improved or declined above the MCID threshold, using published lower and upper bound estimates.
Figure 4. Spaghetti plots showing change of EQ5D Utility scores and VAS from baseline to follow-up for each participant. Each partly transparent line segment denotes one participant, with darker lines indicating overlapping trajectories. The follow-up score is marked with a circle for clarity.
Secondary hypothesis
- There will be a relationship between changes in self-reported health related quality of life and: cancer type, cancer stage, number of concerns expressed, and change in severity of concerns pre and post intervention.
Univariate regressions of EQ-5D scores on age group, gender, cancer type, cancer stage, palliative care, deprivation level, number of concerns reported, follow-up time, and mean change in concerns between assessments can be found in Table 5. Variables that were statistically significantly (p < .05) associated with EQ-5D scores were entered into multiple regression models (Table 6). The variables used were: time elapsed between EQ-5D assessments, mean change in concerns between assessments, and palliative care, with the EQ-5D utility score model also using number of concerns as predictor. Utility score differences were only significantly different between 25-49 years, and 75 years and over, so Age was not included in the multiple regression.
Table 5. Univariate regressions of patient characteristics and outcomes on EQ-5D scores; p-values significant at α<.05 shown in bold. Follow-up time in multiples of 30 day increments was defined as the number of days divided by 30 to approximate number of months.
Both the EQ-5D utility score and VAS models were heteroscedastic so White’s heteroscedasticity-consistent standard errors were used (HC0, using R ‘sandwich’ package version 2.5-1) [22][23]. Following assumption testing [19], the omnibus test of the EQ-5D utility score model was significant at F(4,271) = 13.9, p < .001, adj. R2 = .158, with regression terms Mean change in concern severity between assessments significant at p < .001, Palliative care significant at p < .01, and Number of concerns significant at p < .05. Time elapsed between assessments was not a significant predictor. The omnibus test of the VAS score model was significant at F(3,272) = 8.6, p < .001, adj. R2 = .076, with regression terms Time elapsed between assessments, Mean change in concern severity between assessments significant at p<.001, and Palliative care statistically significant at p < .0001. Regression coefficients, robust standard errors and confidence intervals for both models can be found in Table 5.
HNA average score decreased, indicating a reduction in severity of concerns (figure 3). The mean concern severity was 6.47 [6.23-6.71] at baseline, dropping to 2.90 [2.66-3.13] post intervention. Only three individuals (<1%) showed increase in severity of concern post intervention. Mean concern severity was independent of the number of concerns (Spearman’s ρ=.076, p=.17). In the EQ-5D utility score change model, the strongest predictor was Mean concern change (β=-0.34), meaning that a one standard deviation (1SD) decrease in concern severity at follow-up corresponded to a 0.34SD increase in utility score. Next strongest predictor was Palliative care, which contributed -0.408SD to the EQ-5D utility score change. Finally, when the number of concerns increased by 1SD, the utility score increased by 0.13SD. The time elapsed between EQ-5D assessments was not a significant predictor in the model.
In the VAS model, the strongest predictor was Palliative care, which contributed approximately -8 points on the VAS scale, followed by Mean concern change, where a 1SD decrease in concerns corresponded to a 0.17SD increase in VAS. Time elapsed between assessments was a significant predictor of VAS change in the model, corresponding to a 0.16SD increase in VAS in a 1SD time increase.
Table 6. Linear multiple regression with White’s heteroscedasticity-consistent standard errors for Utility score change and VAS change at follow-up; p-values significant at α<.05 shown in bold