Table 2. Regression Model Estimates of Study Group Effects on 24-Week Outcome Measures.

Outcome measures	Estimated mean or proportion (SE)a		Difference (lower 1-sided 95% confidence limit) or difference (95% CI)b	P valuec
	Stepped palliative care (n = 250)	Early integrated palliative care (n = 257)
Primary outcome test of noninferiority
Quality of life, FACT-L, mean scored	100.6 (1.3) [n = 146]	97.8 (1.3) [n = 145]	2.9 (−0.1)	<.001e
Secondary outcome tests of noninferiority
Discussed end-of-life care with clinician, %f	30.4 (3.3) [n = 190]	33.0 (3.4) [n = 187]	−2.6 (−10.4)	.09e
Length of hospice stay, mean, dg	19.5 (4.3) [n = 159]	34.6 (4.2) [n = 161]	−15.2 (−25.1)	.91e
Secondary outcome test of superiority
Palliative care visits, mean No. per patient	2.4 (0.2) [n = 250]	4.7 (0.1) [n = 257]	−2.3 (−2.7 to −1.8)	<.001
Exploratory outcome tests of superiority
Depression symptoms, PHQ-9, mean score	5.0 (0.3) [n = 139]	5.3 (0.3) [n = 142]	−0.4 (−1.3 to 0.5)
Coping skills, Brief COPE
Approach-oriented coping, mean score	17.7 (0.3) [n = 116]	17.5 (0.3) [n = 115]	0.2 (−0.7 to 1.0)
Avoidant coping, mean score	5.7 (0.2) [n = 126]	5.7 (0.2) [n = 124]	0.0 (−0.5 to 0.5)
Perceptions of prognosis
Perceives goal of therapy is to cure cancer, %	27.9 (3.3) [n = 181]	25.6 (3.2) [n = 184]	2.3 (−6.7 to 11.3)
Perceives cancer is curable, %	22.2 (3.0) [n = 182]	23.8 (3.1) [n = 176]	−1.6 (−10.0 to 6.8)

Abbreviations: Brief COPE, Brief Coping Orientation to Problems Experienced Inventory; FACT-L, Functional Assessment of Cancer Therapy–Lung; PHQ-9, Patient Health Questionnaire 9.

^a All estimates are adjusted for study site and cancer type (non–small cell lung cancer vs small cell lung cancer or mesothelioma). Estimates for FACT-L, PHQ-9, and coping skills are additionally adjusted for baseline scores of outcome variable. Numbers in brackets reflect the number of patients in each group whose data were included in the model.

^b Comparing the lower 1-sided 95% confidence limit with the noninferiority margin corresponds to the primary 1-sided 5% significance level test for noninferiority. Confidence intervals for secondary and exploratory outcomes are not adjusted for multiple testing.

^c P values for secondary outcomes are adjusted for multiple testing using the false discovery rate approach. P values are not reported for exploratory outcomes.

^d Prespecified noninferiority margin, −4.5 points.

^e P value for noninferiority.

^f Prespecified noninferiority margin, −10 percentage points.

^g Prespecified noninferiority margin, −7 days.