Skip to main content

Table 2 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) flow diagram of study enrolment, interventions and assessments

From: Robot assisted radical cystectomy versus open radical cystectomy in bladder cancer (RACE): study protocol of a non-randomized comparative effectiveness study

 

Study period

Enrolment

Allocation

Post-allocation

Close-out

Timeline

4–6 weeks before Radical Cystectomy

Radical Cystectomy

1 m

3 m

6 m

12 m

Timepoint

-t1

0

t1

t2

t3

t4

Enrolment:

 Eligibility screen

X

     

 Informed consent

X

     

Intervention: RARC or ORC

 

X

    

Assessments:

 Quality of Life

X

 

X

X

X

X

 Patient based healthcare usage

X

Monthly

 Clinical data

  

X

X

 

X