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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

ParameterStudy period: time (month)
ScreeningAssessment and follow-upClose-out
Check eligibility against inclusion/exclusion criteria and medication reviewX           
Screening for S. aureus colonizationX  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 examinationXXXXXXXXXX  
PD-related infection: dialysate characteristics and exit-site assessment XXXXXXXXX  
Routine laboratory tests (performed locally)b XXXXXXXXX  
Dialysate adequacy and peritoneal equilibration test X   X   X  
HRQOL and mental healthc X X X X X  
Record medication changes XXXXXXXXX  
Safety profiles: skin reactions and adverse events documentation XXXXXXXXXX 
Hospitalization and emergency visit XXXXXXXXX  
Assess adherence with trial treatment allocation and other medicationd  XXXXXXXX  
Healthcare costs: direct medical cost, direct non-medical cost, and indirect cost X   X   X  
Data monitoring  XXXXXXXX  
Statistical analysis and reporting          XX
  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