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ORAMA: a study to investigate EBPG impact on renal anaemia - design and baseline data
F Locatelli1, A Covic, I C Macdougall
1Department of Nephrology and Dialysis, A. Manzoni Hospital, Lecco - Italy. f.locatelli@ospedale.lecco.it
Insights
Anaemia management in chronic kidney disease (CKD) is suboptimal in Europe. The Optimal Renal Anaemia Management Assessment (ORAMA) study found guideline adherence is low, highlighting the need for improved clinical practice and decision support tools.
Area of Science:
- Nephrology
- Clinical Practice Guidelines
- Anemia Management
Background:
- Published guidelines for anemia management in chronic kidney disease (CKD) require verification of clinical implementation.
- The Optimal Renal Anaemia Management Assessment (ORAMA) is the first European study assessing adherence to 2004 European Best Practice Guidelines (EBPG).
Purpose of the Study:
- To investigate the impact of adherence to EBPG on patient outcomes in CKD.
- To evaluate the effectiveness of a computerised clinical decision support (CDS) system in improving guideline adherence.
Main Methods:
- Randomized trial involving 53 centers across 8 European countries.
- Inclusion of patients with stage 2-5 CKD who were anemic or treated with ESAs/iron.
- Baseline data collection for patients in control and intervention groups (with CDS access).
Main Results:
- 53 centers enrolled 739 patients; 81% were on dialysis.
- Mean baseline hemoglobin (Hb) was 11.2 g/dL; 52% met the EBPG target of >11 g/dL Hb.
- Only 37% maintained Hb >11 g/dL for 3 months pre-study; 96% received ESA therapy.
Conclusions:
- Baseline data indicate suboptimal achievement of EBPG for anemia management in CKD across Europe.
- Final ORAMA results are expected to provide insights into the impact of guideline-based CDS tools on clinical practice and target attainment.
Background:
It is of paramount importance not only to publish anaemia management guidelines for chronic kidney disease (CKD) but also to verify their implementation in clinical practice. The Optimal Renal Anaemia Management Assessment (ORAMA) is the first European study investigating the impact of adherence to the 2004 revised European Best Practice Guidelines (EBPG) and its impact on patient outcomes.
Methods:
Participating centres were randomised into 2 groups: group A with, and group B without, access to an EBPG-based computerised clinical decision support (CDS) system after baseline. Patients with stage 2-5 CKD either anaemic (haemoglobin [Hb] <11 g/dL) or treated with erythropoiesis-stimulating agents (ESAs) and/or iron supplementation were enrolled. Primary end points are based on achievement of anaemia-related guideline targets. Here, baseline data are reported descriptively.
Results:
Fifty-three centres in 8 countries included 739 patients, 81% of whom have received dialysis. Mean baseline Hb was 11.2 g/dL, and 52% of all patients met the EBPG target of >11 g/dL Hb at baseline. However, only 37% of patients had their Hb values >11 g/dL throughout a 3-month prestudy period. Serum ferritin and transferrin saturation were above the guideline target in circa 80% of patients. The vast majority of patients (96%) received ESA therapy at baseline.
Conclusions:
In line with findings from previous studies ORAMA baseline data show that achievement of EBPG is suboptimal across European countries. Final results promise an insight into the impact of guideline-based CDS tools on clinical practice and target attainment.
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