The Stockholm CREAtinine Measurements Project (SCREAM)

The Stockholm CREAtinine Measurements (SCREAM) Project

The Stockholm CREAtinine Measurements (SCREAM) project is a healthcare utilization cohort including, at present, all adult residents in Stockholm between 2006 and 2021. The region of Stockholm had a population of 2.3 million citizens in 2021and provides universal healthcare with a single unified health-system. Administrative databases with complete information on socidemographic data, healthcare use, diagnoses and therapeutic/surgical procedures, and vital status were enriched with performed laboratory tests, dispensed prescriptions at Swedish pharmacies and validated kidney replacement therapy endpoints. Registries were linked and de-identified by the Swedish National Board of Welfare and are considered to have no or minimal loss to follow-up. Because the study utilized de-identified data, it was deemed not to require informed consent and was approved by the regional ethical review boards and the Swedish National Board of Welfare.

For detailed description of available data and linked registers please consult:

https://pubmed.ncbi.nlm.nih.gov/35028991/

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Hypertension; Diabetes Mellitus; Chronic Kidney Diseases; Acute Kidney Injury
• Intervention / Treatment: Drug: Initiation of specific medications; Procedure: Undertaking of specific procedures; Diagnostic test: Abnormalities in specific laboratory tests

Detailed Description

Please consult cohort description in:

https://pubmed.ncbi.nlm.nih.gov/35028991/ https://pubmed.ncbi.nlm.nih.gov/26798472/

• Study Type: Observational
• Enrollment (Actual): 3200000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Stockholm residents with/without ever testing for creatinine or albumuninuria

Description

Inclusion Criteria:

For both cohorts:

Be a resident of Stockholm during 2006-2021, of all ages

For the primary cohort:

To have undertaken at least one test of serum creatinine or albuminuria during 2006-2021. If this condition is met, we will then extract a broad range of laboratory tests

For the secondary cohort:

Anyone not undertaking a test of serum creatinine or albuminuria will conform the secondary cohort. In this cohort we will not extract any other laboratory test, but will obtain the rest of healthcare information

Exclusion criteria:

None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse health events by levels of kidney function	multiple outcomes evaluated such as cardiovascular events, fractures, dementia, cancer, etc, all of them based on claims data and/or laboratory data	2006-2021
Safety and efficacy of medications by levels of kidney function	multiple outcomes evaluated depending on the treatments of interest, all of them based on claims data and/or laboratory data	2006-2021
Effect of medications or conditions on kidney function decline	Evaluation of changes in kidney function over time upon occurrence of a certain condition (i.e., heart failure or covid19 infection) or initiation of a specific medication	2006-2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse health events associated to laboratory abnormalities	Same as primary objectives but for other laboratory abnormalities different from kidney function measures	2006-2021

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm
• Investigators: Principal Investigator: Juan J Carrero, Prof, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2006
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cardiovascular Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Acute Kidney Injury
• Other Study ID Numbers: 000001 (Other Grant/Funding Number: New York City Mayors Office Community Mental Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Possibility to share data for collaborative academic research purposes that comply with institutional, national and international ethic principles and legislation on data sharing, access and investigation
• IPD Sharing Time Frame: For the time required to perform the collaborative project
• IPD Sharing Access Criteria: Primarily by welcoming researchers to analyse the data physically in Stockholm. Exceptionally by opening secure VDI connections to work under our online servers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No