Preoperative anaemia is associated with an increased risk of morbidity and mortality. Iron deficiency is still the top-ranking cause of anaemia worldwide (Vos et al.). Therefore, it is an important target to treat anaemia before elective surgery. By supplementing iron parenterally or orally before surgery, sometimes in conjunction with other interventions, haemoglobin levels may increase and thus, among other effects, the need for red blood cell transfusion is likely to be reduced. Several studies aimed to explore treatment of preoperative iron deficiency anaemia and its effect on patient outcome including possible adverse events of iron supplementation. However, the broad heterogeneity of measured and reported outcomes reduces comparability of clinical studies in the field.
We aim to develop a core outcome set for clinical trials addressing iron deficiency and iron deficiency anaemia in patients undergoing surgery. With this study we will set out to systematically collect all measured and reported outcomes in clinical studies on this topic published to date. The results of this systematic review will be consented by a Delphi process among experts in the field and including other important stakeholders, e.g. patients.
Vos, T., et al. “Global, Regional, and National Incidence, Prevalence, and Years Lived with Disability for 310 Diseases and Injuries, 1990–2015: A Systematic Analysis for the Global Burden of Disease Study 2015.” The Lancet, vol. 388, no. 10053, Lancet Publishing Group, Oct. 2016, pp. 1545–602, doi:10.1016/S01406736(16)31678-6.
Principal investigator: Magdalena Sitter
Co-Investigators. Dr. Stephanie Weibel, Maria Popp,
Supervisors: Prof. Dr. Patrick Meybohm, Prof. Dr. Peter Kranke
Department of Anesthesiology and Critical Care, University Hospital Wuerzburg, Wuerzburg
Disease Category: Anaesthesia & pain control
Disease Name: Iron Deficiency Anaemia
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Other
- Clinical experts
- Patient/ support group representatives
- COS for clinical trials or clinical research
- Delphi process
- Systematic review
We will conduct a systematic review of outcomes reported in clinical trials, including RCTs and observational studies, addressing iron deficiency and iron deficiency anaemia in patients undergoing surgery. The aim is to identify definitions, laboratory parameters and measurements, as well as outcomes reported for the treatment of iron deficiency and iron deficiency anaemia using iron (intravenously or orally) alone or in combination with other compounds (e.g.. EPO).
Reach consensus for the core outcome set:
Key stakeholders: group of experts in the field of perioperative iron deficiency anaemia; patients
Modified Delphi technique: to reach consensus, the key stakeholders will be asked to assess the identified outcomes using pre-defined criteria. The assessments will be performed in several rounds in the format of online surveys.