Changing reference intervals for haemoglobin in Denmark: Clinical and financial aspects

Based on international experiences and altering demography the reference intervals (RI) for haemoglobin (Hb) concentrations in blood were changed in Denmark in 2013 from 113 - 161 g/L to 117 - 153 g/L for women and from 129 - 177 g/L to 134 - 170 g/L for men. The aim of this study was to determine the derived change in prevalence of anaemia and the change in yearly health care costs of diagnostic investigations associated with the expected, as we hypothesized, increased prevalence and health care costs.

Data from 96,314 non-hospitalised patients (55,341 females and 40,973 males, aged 18 - 105 years) from general practitioners and community specialists of Funen, Denmark, were extracted from the laboratory information system. The prevalence of anaemia according to the new and the old RI were investigated, and additional costs were calculated based on estimated additional blood analyses and nationally recommended endoscopic procedures.

Changing the Hb RI increased the number of anaemic patients by 52% (3450 patients) over a two-year period. With new RI the proportion of anaemic elderly above 80 years was 20.5% for females and 43.9% for males. Annual costs of derived additional assessments due to the altered RI were estimated to be 5.7 million €, which equals the cost of 1214 knee replacement surgeries in Denmark.

Changing the Hb RI has been expensive, despite the fact that no outcome studies have justified the alteration. The methodological approach for establishing new RI, here particularly for Hb, should be thoroughly considered. In general, physicians should use RI with caution.