Pragmatic randomised evaluation of stable thoracolumbar fracture treatment outcomes (PRESTO): study protocol for a randomised controlled feasibility trial combined with a qualitative study and survey

Table 2 Study assessment schedule

	STUDY PERIOD
	Enrolment	Allocation	Post-allocation
Time point	Baseline (pre-randomisation)	Randomisation	Intervention delivery	Week 2	Month 3	Month 6¹
Enrolment:
Eligibility screen	x
Informed consent	x
Demographic data	x
Allocation		x
Intervention:
Non-operative management			x
Surgical fixation			x
Assessments:
Oswestry Disability Index (ODI)	x (pre- and post-injury)				x	x
Visual analogue scale (VAS) for pain	x (post-injury)				x	x
Short Form-12 (SF12)	x (pre-injury)				x²	x²
EuroQol EQ-5D-5L	x (pre- and post-injury)				x	x
Patient & surgeon preferences	x
Sagittal plane kyphosis	x			x	x	x
Treatment information				x	x	x
Basic health economics data (i.e. health care resource use)					x	x

ISSN: 2055-5784