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Table 3 Schedule of observation and procedures

From: Comparative Effectiveness of Local Application of Chlorhexidine Gluconate, Mupirocin Ointment, and Normal Saline for the Prevention of Peritoneal Dialysis-related Infections (COSMO-PD Trial): a multicenter randomized, double-blind, controlled protocol

Parameter

Study period: time (month)

Screening

Assessment and follow-up

Close-out

-1

0

3

6

9

12

15

18

21

24

25

26

Check eligibility against inclusion/exclusion criteria and medication review

X

           

Screening for S. aureus colonization

X

  

X

 

X

 

X

 

X

  

Gartering informed consent and randomization

 

X

          

Sociodemographic and lifestyle dataa

 

X

          

Medical history by Charlson comorbidity index and ESKD etiology

 

X

          

Physical examination

X

X

X

X

X

X

X

X

X

X

  

PD-related infection: dialysate characteristics and exit-site assessment

 

X

X

X

X

X

X

X

X

X

  

Routine laboratory tests (performed locally)b

 

X

X

X

X

X

X

X

X

X

  

Dialysate adequacy and peritoneal equilibration test

 

X

   

X

   

X

  

HRQOL and mental healthc

 

X

 

X

 

X

 

X

 

X

  

Record medication changes

 

X

X

X

X

X

X

X

X

X

  

Safety profiles: skin reactions and adverse events documentation

 

X

X

X

X

X

X

X

X

X

X

 

Hospitalization and emergency visit

 

X

X

X

X

X

X

X

X

X

  

Assess adherence with trial treatment allocation and other medicationd

  

X

X

X

X

X

X

X

X

  

Healthcare costs: direct medical cost, direct non-medical cost, and indirect cost

 

X

   

X

   

X

  

Data monitoring

  

X

X

X

X

X

X

X

X

  

Statistical analysis and reporting

          

X

X

  1. aTo include date of birth, date of PD initiation, gender, weight, body mass index, marital status, education, income, insurance, smoking and alcohol status
  2. bTo include complete blood count, biochemistry, liver function test, and dialysate profile parameter
  3. cTo include the Kidney Disease Quality of Life-36, EuroQol-5 dimension-5 level, and BDI-II, Beck Depression Inventory-II questionnaires
  4. dTo include the visual analog scale-medication adherence and the medication-taking behavior measure for Thai patients questionnaires
  5. Abbreviations: ESKD end-stage kidney disease, HRQOL health-related quality of life, PD peritoneal dialysis, S. aureus Staphylococcus aureus