Secondary Data Analysis of Patients at Risk for CKD to Inspect CKD Prevalence, Diagnosis Rates, Diagnostic Behaviour, Treatment Patterns and Patient Characteristics

Study Overview
=================
Brief Summary
-----------------
This study is a national secondary data analysis to determine the prevalence of diagnosed and undiagnosed CKD in German primary care offices in a patient population at high risk for the development and progression of CKD. Furthermore, it addresses the question of how CKD screening, monitoring and treatment of these patients is conducted within the German primary care setting.

Detailed Description
-----------------
The study does not attempt to test any specific a priori hypothesis; it is descriptive only. Data on general patient characteristics, health insurance details, participation in disease management programs and/or family doctor-centred care, diagnoses, prescriptions, surgeries, and procedures, used billable services and laboratory test results are documented during daily routine by the physician. The data used in this setting are part of routine visits, dating back a maximum of 24 months from the date of first data transfer within the study period.

Official Title
-----------------
InspeCKD - Secondary Data Analysis of Patients at Risk for Chronic Kidney Disease (CKD) in German Primary Care Offices to Inspect CKD Prevalence, Diagnosis Rates, Diagnostic Behaviour, Treatment Patterns and Patient Characteristics

Conditions
-----------------
Chronic Kidney Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years at start of the patient´s observation period Having at least one of the following diseases (based on the documented ICD-10 code): Type 1 diabetes Type 2 diabetes Hypertension Cardiovascular disease, including: Coronary and/or other atherosclerosis Myocardial infarction Heart failure Peripheral arterial disease Arrythmia Stroke Having at least one year (52 weeks) of observation period Exclusion Criteria: NA
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with diagnosed CKD | To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD | Dating back a maximum of 24 months from the date of first data transfer | 
| Percentage of patients with undiagnosed CKD | To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD | Dating back a maximum of 24 months from the date of first data transfer | 
| Percentage of patients with undiagnosed or diagnosed CKD | To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD | Dating back a maximum of 24 months from the date of first data transfer | 
| Percentage of patients that fulfil CKD definition according to KDIGO (Kidney Disease: Improving Global Outcomes) | To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD | Dating back a maximum of 24 months from the date of first data transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of serum creatinine measurements per patient per year (52 weeks) in the study period | To evaluate the use of CKD-related laboratory diagnostics in all eligible patients | Dating back a maximum of 24 months from the date of first data transfer | 
| Average number of UACR measurements per patient per year (52 weeks) during the study period | To evaluate the use of CKD-related laboratory diagnostics in all eligible patients | Dating back a maximum of 24 months from the date of first data transfer | 
| Percentage of patients with no, one, or at least two serum creatinine measurements among all eligible patients during the study period | To evaluate the use of CKD-related laboratory diagnostics in all eligible patients | Dating back a maximum of 24 months from the date of first data transfer | 
| Percentage of patients with no, one, or at least two UACR measurements among all eligible patients during the study period | To evaluate the use of CKD-related laboratory diagnostics in all eligible patients | Dating back a maximum of 24 months from the date of first data transfer | 
| Percentage of patients who did not have serum creatinine and UACR determined at least once | To evaluate the use of CKD-related laboratory diagnostics in all eligible patients | Dating back a maximum of 24 months from the date of first data transfer | 
| Percentage of patients in whom both serum creatinine and UACR were determined at least once | To evaluate the use of CKD-related laboratory diagnostics in all eligible patients | Dating back a maximum of 24 months from the date of first data transfer | 
| Percentage of patients in whom both serum creatinine and UACR were determined at least twice | To evaluate the use of CKD-related laboratory diagnostics in all eligible patients | Dating back a maximum of 24 months from the date of first data transfer | 
| Percentage of patients with at least two serum creatinine measurements with an interval of at least three months among all eligible patients in the study period | To evaluate the use of CKD-related laboratory diagnostics in all eligible patients | Dating back a maximum of 24 months from the date of first data transfer | 
| Percentage of patients with at least two UACR measurements with an interval of at least three months among all eligible patients in the study period | To evaluate the use of CKD-related laboratory diagnostics in all eligible patients | Dating back a maximum of 24 months from the date of first data transfer | 
| Percentage of patients with at least two UACR and serum creatinine measurements with an interval of at least three months among all eligible patients in the study period | To evaluate the use of CKD-related laboratory diagnostics in all eligible patients | Dating back a maximum of 24 months from the date of first data transfer | 
| Age at index date | To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date | Dating back a maximum of 24 months from the date of first data transfer | 
| Sex at index date | To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date | Dating back a maximum of 24 months from the date of first data transfer | 
| BMI at index date | To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date | Dating back a maximum of 24 months from the date of first data transfer | 
| Concurrent medication at index date | To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date | Dating back a maximum of 24 months from the date of first data transfer | 
| Comorbidities at index date | To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date | Dating back a maximum of 24 months from the date of first data transfer | 
| eGFR values at index date | To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date | Dating back a maximum of 24 months from the date of first data transfer | 
| UACR values at index date | To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date | Dating back a maximum of 24 months from the date of first data transfer | 
| Percentage of patients among diagnosed or undiagnosed CKD patients that are treated with either/or renin-angiotensin-system-inhibitors (ACEi, ARB), SGLT2i, statin or selective mineralocorticoid receptor antagonist at index date | To evaluate the use of medication to treat CKD among patients with diagnosed and undiagnosed CKD | Dating back a maximum of 24 months from the date of first data transfer | 
| Percentage of patients among diagnosed or undiagnosed CKD patients that are newly initiated with either/or renin-angiotensin-system-inhibitors (ACEi, ARB), SGLT2i, statin, selective mineralocorticoid receptor antagonist within 6 months after index date | To evaluate the use of medication to treat CKD among patients with diagnosed and undiagnosed CKD | Dating back a maximum of 24 months from the date of first data transfer | 
| Percentage of patients with impaired kidney function | To assess the prevalence of impaired kidney function in all eligible patients | Dating back a maximum of 24 months from the date of first data transfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Diseases, CKD, SGLT2i