How effective is home-based albuminuria screening?

Chronic kidney disease (CKD) has a rising global prevalence and is expected to become the fifth leading cause of death by 2030. Increased albuminuria defines the early stages of CKD and is among the strongest risk factors for progressive CKD and cardiovascular disease. The value of population screening for albuminuria to detect CKD in an early phase has yet to be studied. We aimed to evaluate the effectiveness of two home-based albuminuria population screening methods.

Methods

Towards Home-based Albuminuria Screening (THOMAS) was a prospective, randomised, open-label implementation study that invited Dutch adults aged 45–80 years for albuminuria screening. Individuals were randomly assigned (1:1) to screening by applying either a urine collection device (UCD) that was sent by post to a central laboratory for measurement of the albumin-to-creatinine ratio (ACR) by immunoturbidimetry or to screening via a smartphone application that measures the ACR with a dipstick method at home. Randomisation was done with a four-block method via a web-based system and was stratified by age, sex, and socioeconomic status.

Findings

15 074 participants were enrolled between Nov 14, 2019, and March 19, 2021. 7552 (50·1%) were randomly assigned to home-based albuminuria screening by the UCD method and 7522 (49·9%) were assigned to albuminuria screening by the smartphone application method. The participation rate of the home-based screening was 4484 (59·4% [95% CI 58·3–60·5]) of the 7552 invited individuals for the UCD method and 3336 (44·3% [43·2–45·5]) of 7522 invited individuals for the smartphone application method (p<0·0001). Increased ACR was confirmed by home-based testing in 150 (3·3% [95% CI 2·9–3·9]) of 4484 individuals for the UCD method and 171 (5·1% [4·4–5·9]) of 3336 indivduals for the smartphone application method. 124 (82·7% [95% CI 75·8–87·9]) of 150 individuals assigned to the UCD method and 142 (83·0% [76·7–87·9]) of 171 participants assigned to the smartphone application method attended the elaborate screening. Sensitivity to detect increased ACR was 96·6% (95% CI 91·5–99·1) for the UCD method and 98·1% (89·9–99·9) for the smartphone application method, and specificity was 97·3% (94·7–98·8) for the UCD method and 67·9% (62·0–73·3) for the smartphone application method, indicating that the test characteristics of only the UCD method were sufficient for screening. Albuminuria, hypertension, hypercholesterolaemia, and decreased kidney function were newly diagnosed in 77 (62·1%), 44 (35·5%), 30 (24·2%), and 27 (21·8%) of 124 participants for the UCD method, respectively. Of the 124 participants assigned to the UCD method who completed elaborate screening, 111 (89·5%) were referred to their general practitioner for treatment because of newly diagnosed CKD or cardiovascular disease risk factors or known risk factors outside the target range.

Home-based screening of the general population for increased ACR using a UCD had a high participation rate and correctly identified individuals with increased albuminuria and yet unknown or known but outside target range CKD and cardiovascular risk factors. By contrast, the smartphone application method had a lower at-home participation rate than the UCD method and the test specificity was too low to accurately assess individuals for risk factors during the elaborate screening. The UCD screening strategy could allow for an early start of treatment to prevent progressive kidney function loss and cardiovascular disease in patients with CKD.

Reference:

Dominique van Mil, Lyanne M Kieneker, Birgitte Evers-Roeten, Prof Marc H M Thelen, Hanne de Vries, Prof Marc H Hemmelder, et al.Participation rate and yield of two home-based screening methods to detect increased albuminuria in the general population in the Netherlands (THOMAS): a prospective, randomised, open-label implementation study. Published:August 16, 2023DOI: https://doi.org/10.1016/S0140-6736(23)00876-0

Keywords:

effective, home-based, albuminuria, screening, Dominique van Mil, Lyanne M Kieneker, Birgitte Evers-Roeten, Prof Marc H M Thelen, Hanne de Vries, Prof Marc H Hemmelder, the lancet.