Skip to main content

Table 1 Visit schedule

From: The efficacy of indwelling pleural catheter placement versus placement plus talc sclerosant in patients with malignant pleural effusions managed exclusively as outpatients (IPC-PLUS): study protocol for a randomised controlled trial

 

Timings

Event

Pre-screening

Consent/baseline

IPC insertion

Pre-randomisation

Randomisation

Follow-ups (days post-randomisation)

On-going

14

28

42a

56a

70

Provide patient information sheet

X

          

Sign consent

 

X

         

Thoracic ultrasound

 

X

  

X

X

X

X

X

X

 

Chest X-ray

  

X

 

X

X

X

X

X

X

 

Standard blood tests

 

X

         

Trial blood samples (Southmead and Oxford only)

 

X

         

Trial pleural fluid samples (Southmead and Oxford only)

  

X

 

X

X

X

X

X

X

 

Manometry

  

X

        

Instillation of talc/placebo

    

X

      

Community IPC drainages

   

Xb

      

X

Drainage booklet

  

X

       

X

Daily VAS scores

   

X

X

     

X

Collection of VAS booklet

    

X

X

X

X

X

X

 

EQ-5D questionnaire

 

X

  

X

X

X

X

X

X

 

QLQ-C30 questionnaire

 

X

  

X

X

X

X

X

X

 

Patient diary

   

X

      

X

  1. IPC = Indwelling pleural catheter.
  2. VAS = Visual analogue scale.
  3. EQ-5D = EuroQuol 5D.
  4. QLQ-C30 = Quality of Life Questionnaire C30.
  5. aVisits at days 42 and 56 may be done over the telephone and therefore the patient would not have a chest X-ray or thoracic ultrasound.
  6. bMinimum of three drainages in the community between IPC insertion and randomisation.