Regional differences in hemodialysis practices, treatment strategies and patient outcomes over time in Turkey: A Multicenter Observational Cohort Study in Turkish Hemodialysis Patients (20150316)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  End stage renal disease

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  2500

Study design details

• Main study objective:
  To define differences in patient outcomes in relation with treatment strategies in different regions of Turkey.
• Outcomes:
  The rate of patient all cause mortality and cardiovascular morbidity in differentregions of Turkey in relation with treatment stragies. The rate of patient all-cause mortality and cardiovascular morbidity in different regions of Turkey in relation with HD practices.The rate of hospitalizations and infections in different regions of Turkey.The difference in Hb levels in incident and prevalent HD patients in different regions of Turkey.Hb concentrations in relation with dialysis vintage, age and gender.
• Data analysis plan:
  This study is descriptive.Only summary statistics and interval estimates will be provided.The number of clinical outcomes per subject will be tallied.Normal approximation 95% confidence intervals(CI) will be computed around the proportion estimates. The rate of mortality and morbidity will be calculated as the number of clinical outcomes or death divided by the duration on study.Poisson CI will be computed around the rate estimate. The proportions, rates and CI will be computed for the whole study population and for subgroups defined by treatment. The secondary outcomes will assess the proportions and rates from the primary outcome by geographic regions. Regions will be defined both by HD practice and bySHPT parameters.