Table 3.

Associations between symptoms/unmet needs and HrQOL at enrollment and 12-month time points

Enrollment variableEnrollment12 months
nEstimate∗ 95% CIP valuenEstimate∗ 95% CIP value
Enrollment BPI total 153 −3.42 −4.41 to −2.42 <.0001 124 −2.91 −3.93 to −1.88 <.0001 
Any clinically relevant pain 153 −14.83 −20.47 to −9.19 <.0001 124 −10.86 −16.66 to −5.06 .0003 
Enrollment BFI total 153 −4.71 −5.42 to −4.01 <.0001 122 −3.43 −4.23 to −2.64 <.0001 
Any clinically relevant fatigue 153 −21.25 −27.09 to −15.41 <.0001 122 −16.87 −22.28 to −11.45 <.0001 
Top 3 ECD-SS symptoms: severity 153 −5.00 −6.12 to −3.88 <.0001 122 −4.15 −5.07 to −3.24 <.0001 
Top 5 ECD-SS symptoms: severity 153 −5.02 −6.20 to −3.85 <.0001 122 −4.28 −5.27 to −3.29 <.0001 
Top ECD-SS symptom: other 157 Ref — — 125 Ref — — 
Top ECD-SS symptom: neurologic 157 −8.33 −15.50 to −1.16 .02 125 −7.30 −14.42 to −0.18 .04 
Top ECD-SS symptom: GI 157 −4.06 −16.98 to 8.85 .54 125 −1.23 −15.58 to 13.11 .87 
Top ECD-SS symptom: pain 157 −7.46 −16.35 to 1.43 .10 125 −4.98 −13.43 to 3.48 .25 
Top ECD-SS symptom: vision 157 −13.68 −31.18 to 3.82 .12 125 1.78 −13.76 to 17.32 .82 
Top ECD-SS symptom: respiratory 157 −5.43 −21.55 to 10.69 .51 125 5.78 −9.76 to 21.32 .46 
Unmet health care service needs 153 −12.31 −18.26 to −6.36 <.0001 120 −17.32 −23.41 to −11.22 <.0001 
Unmet psychological/emotional needs 155 −19.54 −24.86 to −14.21 <.0001 124 −17.88 −23.05 to −12.72 <.0001 
Unmet physical and daily health needs 157 −22.99 −27.88 to −18.11 <.0001 125 −16.63 −21.84 to −11.41 <.0001 
Unmet care and support needs 152 −17.15 −23.80 to −10.49 <.0001 123 −14.94 −22.87 to −7.01 .0003 
Unmet sexual needs 150 −14.76 −21.53 to −8.00 <.0001 119 −11.32 −18.45 to −4.20 .002 
No. of unmet needs 158 −1.71 −2.01 to −1.41 <.0001 125 −1.90 −2.25 to −1.54 <.0001 
≥3 unmet needs 158 −20.24 −25.55 to −14.92 <.0001 125 −20.91 −25.61 to −16.21 <.0001 
≥5 unmet needs 158 −21.86 −26.77 to −16.95 <.0001 125 −21.44 −26.25 to −16.63 <.0001 
≥10 unmet needs 158 −22.02 −27.54 to −16.50 <.0001 125 −23.45 −29.54 to −17.35 <.0001 
Enrollment variableEnrollment12 months
nEstimate∗ 95% CIP valuenEstimate∗ 95% CIP value
Enrollment BPI total 153 −3.42 −4.41 to −2.42 <.0001 124 −2.91 −3.93 to −1.88 <.0001 
Any clinically relevant pain 153 −14.83 −20.47 to −9.19 <.0001 124 −10.86 −16.66 to −5.06 .0003 
Enrollment BFI total 153 −4.71 −5.42 to −4.01 <.0001 122 −3.43 −4.23 to −2.64 <.0001 
Any clinically relevant fatigue 153 −21.25 −27.09 to −15.41 <.0001 122 −16.87 −22.28 to −11.45 <.0001 
Top 3 ECD-SS symptoms: severity 153 −5.00 −6.12 to −3.88 <.0001 122 −4.15 −5.07 to −3.24 <.0001 
Top 5 ECD-SS symptoms: severity 153 −5.02 −6.20 to −3.85 <.0001 122 −4.28 −5.27 to −3.29 <.0001 
Top ECD-SS symptom: other 157 Ref — — 125 Ref — — 
Top ECD-SS symptom: neurologic 157 −8.33 −15.50 to −1.16 .02 125 −7.30 −14.42 to −0.18 .04 
Top ECD-SS symptom: GI 157 −4.06 −16.98 to 8.85 .54 125 −1.23 −15.58 to 13.11 .87 
Top ECD-SS symptom: pain 157 −7.46 −16.35 to 1.43 .10 125 −4.98 −13.43 to 3.48 .25 
Top ECD-SS symptom: vision 157 −13.68 −31.18 to 3.82 .12 125 1.78 −13.76 to 17.32 .82 
Top ECD-SS symptom: respiratory 157 −5.43 −21.55 to 10.69 .51 125 5.78 −9.76 to 21.32 .46 
Unmet health care service needs 153 −12.31 −18.26 to −6.36 <.0001 120 −17.32 −23.41 to −11.22 <.0001 
Unmet psychological/emotional needs 155 −19.54 −24.86 to −14.21 <.0001 124 −17.88 −23.05 to −12.72 <.0001 
Unmet physical and daily health needs 157 −22.99 −27.88 to −18.11 <.0001 125 −16.63 −21.84 to −11.41 <.0001 
Unmet care and support needs 152 −17.15 −23.80 to −10.49 <.0001 123 −14.94 −22.87 to −7.01 .0003 
Unmet sexual needs 150 −14.76 −21.53 to −8.00 <.0001 119 −11.32 −18.45 to −4.20 .002 
No. of unmet needs 158 −1.71 −2.01 to −1.41 <.0001 125 −1.90 −2.25 to −1.54 <.0001 
≥3 unmet needs 158 −20.24 −25.55 to −14.92 <.0001 125 −20.91 −25.61 to −16.21 <.0001 
≥5 unmet needs 158 −21.86 −26.77 to −16.95 <.0001 125 −21.44 −26.25 to −16.63 <.0001 
≥10 unmet needs 158 −22.02 −27.54 to −16.50 <.0001 125 −23.45 −29.54 to −17.35 <.0001 
∗

Estimate interpretation: a 1-unit increase in enrollment symptom is associated on average with this change in total FACT-G score points. For example, a patient with an enrollment BPI total score of 6 will have, on average, a lower total FACT-G score at enrollment of 3.42 points than a patient with an enrollment BPI total score of 5. Another example: a patient with unmet health care service needs at 12 months will have, on average, a lower total FACT-G score at 12-months of 17.32 points than a patient with met health care service needs at 12 months.

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