Table 1.

Key elements of the RadComp pragmatic approach to study design

Domain	Typical explanatory RCT	RadComp Pragmatic RCT
Blinding	Open label	Open label
Participant eligibility	Highly selected (avoid diluting effect)	Little selection beyond the clinical indication for RT
Intervention flexibility	Standardised, inflexible treatment guidelines	Flexible treatment guidelines, promote local care standards
Practitioner expertise	Expert subspecialists at elite academic settings	Academic and community settings, real-world care
Follow-up	Frequent research visits, more extensive than routine care	Annual research visits, tied to routine care; engage patients
Primary outcome	Clinically meaningful, often surrogate	Clinically meaningful, patient-centric MCE and HRQOL
Event adjudication	Variable	Independent, blinded, centralised primary outcome adjudication
Adherence	Stringent for both patient and provider	Relaxed, usual care, best practice recommendations
Analysis	Intention to treat	Intention to treat
Relevance to practice	Indirect: trial design ≠ needs of stakeholders	Direct: trial design = needs of patients and stakeholders

HRQOL, health-related quality of life; MCE, major cardiovascular event; RadComp, Radiotherapy Comparative Effectiveness; RCT, randomised controlled trial; RT, radiation therapy.