Table 3. Patient-Reported Secondary Outcomes of Health-Related Quality of Life and Treatment Burden and Other Prespecified Outcomes of Adherence to Anticoagulant Therapy.

Outcomes	Direct oral anticoagulants			Low-molecular-weight heparin			Between-group difference (95% CI)a
	Baseline	Follow-up	Difference	Baseline	Follow-up	Difference
Health-related quality of life, mean scoreb
At baseline and 3-mo follow-up		n = 212/295c			n = 197/280c
Physical health	36.6	38.4	1.8d	36.8	37.5	0.7d	1.1 (−0.6 to 2.8)
Mental health	49.4	49.1	−0.3d	48.1	48.8	0.7d	−1.0 (−3.1 to 1.0)
At baseline and 6-mo follow-up		n = 191/262c			n = 177/253c
Physical health	36.9	39.3	2.4d	37.0	37.7	0.7d	1.7 (−0.4 to 3.8)
Mental health	49.6	49.9	0.3d	48.1	49.0	0.9d	−0.6 (−2.6 to 1.4)
Anti-Clot Treatment Scale, mean scoree
At 3-mo follow-up		n = 212/295c			n = 197/280c
Benefit		11.2			10.7		0.5 (−0.2 to 1.1)
Burden		56.7			53.3		3.3 (2.3 to 4.4)
At 6-mo follow-up		n = 191/262c			n = 177/253c
Benefit		11.6			11.3		0.3 (−0.3 to 0.8)
Burden		56.5			54.1		2.3 (1.2 to 3.5)
Adherence to anticoagulant therapy, %f
At 3-mo follow-up
Taking anticoagulant as randomized		82.1 (n = 271/330)			72.7 (n = 224/308)		9.4 (2.9 to 15.9)
Taking any anticoagulant		83.9 (n = 277/330)			85.4 (n = 263/308)		−1.5 (−7.0 to 4.1)
At 6-mo follow-up
Taking anticoagulant as randomized		70.9 (n = 234/330)			59.4 (n = 183/308)		11.5 (4.1 to 18.8)
Taking any anticoagulant		72.7 (n = 240/330)			72.1 (n = 222/308)		0.6 (−6.3 to 7.6)

^a Direct oral anticoagulant group minus low-molecular-weight heparin group.

^b Health-related quality of life was measured using the 12-Item Short Form Health Survey subscales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity.

^c Respondents/nondeceased participants.

^d Change in score from baseline.

^e The Anti-Clot Treatment Scale is a 15-item patient-reported measure of satisfaction with anticoagulant treatment. The benefit scale has 3 items, with scores ranging from 3 to 15; higher scores indicate greater satisfaction with treatment. The burden scale has 12 items with scores ranging from 12 to 60; higher scores indicate greater satisfaction (lower burden).

^f Participants who died prior to month 3 or 6 were considered adherent if they were not known to have stopped treatment prior to death. Adherence to anticoagulant therapy was ascertained based on both participant surveys and electronic health records. Randomized anticoagulants were any of apixaban, dabigatran, edoxaban, or rivaroxban for the direct oral anticoagulant group and any of enoxaparin, dalteparin, or fondaparinux for the low-molecular-weight heparin group. Any anticoagulant was defined as any of the medications listed above plus warfarin. Patients who died or were lost to follow-up at 3 or 6 months were included in the denominator in calculating these proportions.