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External quality assessment of HbA1c and its effect on comparison between Swedish pediatric diabetes clinics. Experiences from the Swedish pediatric diabetes quality register (Swediabkids) and Equalis.

Artikel i vetenskaplig tidskrift
Författare Bengt Lindblad
Gunnar Nordin
Publicerad i Clinical chemistry and laboratory medicine : CCLM / FESCC
Volym 51
Nummer/häfte 10
Sidor 2045–2052
ISSN 1434-6621
Publiceringsår 2013
Publicerad vid Institutionen för kliniska vetenskaper, Avdelningen för pediatrik
Sidor 2045–2052
Språk en
Länkar dx.doi.org/10.1515/cclm-2013-0226
Ämneskategorier Pediatrik

Sammanfattning

Abstract Background: To explore to what extent measurement error can explain the variation of mean patient HbA1c between clinics. Methods: For each year 2005-2010 data from 5380-6985 children, age <18 years, in 35-43 Swedish pediatric clinics was analyzed. Each year 13,000-19,000 HbA1c analyses were evaluated. Year mean HbA1c for each patient was calculated for HbA1c values when insulin dose was ≥0.5 U/kg. In Sweden HbA1c values were during the study period standardized to the Mono S level, HbA1c(Mono S)%, but are given also in the international unit HbA1c(IFCC), mmol/mol. Performance of locally measured HbA1c is monitored by Equalis through monthly external quality assessment (EQA) schemes. Results: The yearly mean bias term for each clinic varied from -0.54 to 0.41 HbA1c(Mono S)%. The bias between clinic HbA1c and target value improved during the 6 years and the mean bias was for 79%-88% of clinics within the recommended level ±0.14 HbA1c% the last 2 years. Inter-clinic mean HbA1c had a wide interquartile range, 0.30-0.43 HbA1c(Mono S)% [3.2-4.5 HbA1c(IFCC)mmol/mol]. Conclusions: Regular participation in EQA schemes is necessary when comparing HbA1c values. The measurement error decreased during the 6-year period and explained from 28% to <10% of the inter-clinic variation in year mean clinic HbA1c.

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