The use of erythropoiesis stimulating agents (ESAs) has provided significant therapeutic benefits to patients suffering from cancer-related anemia. Though ESAs have been shown to effectively restore hemoglobin levels and improve patient quality of life, some variable treatment outcomes have spurred organizations such as the European Society for Research and Treatment of Cancer (EORTC) to propose evidence-based guidelines to improve clinician diagnosis and treatment. An emerging method to match clinical practice with established guidelines is to design computerized systems based on patient data. The RESPOND system, a web-based clinical guidance system, is the focus of a recent study analyzing the impact of evidence-based guidelines on patient care.

To test whether the RESPOND system produced effective, evidence-based guidelines, a two-step validation process was undertaken. First, a panel of physicians and nurses with significant clinical and scientific experience in cancer-related anemia rated the accuracy of the EORTC-based algorithms developed for the RESPOND system. If an algorithm was judged to be accurate, it will indicate a reliable analysis model, as well as an adequate guideline. Second, a cohort of adult cancer patients with anemia will be examined in a clinical trial. The trial will compare clinician practice patterns with EORTC guidelines in groups that used RESPOND versus groups that did not use RESPOND. For each patient, a congruence score will be given which quantifies anemia assessment, management, and outcome according to EORTC guidelines.

Currently, the first step of the RESPOND validation trial has been completed. After one round of review, all but 5 algorithms were approved by the review panel, and after a follow-up revision, a consensus was reached unanimously on all algorithmic definitions. Step 2, the assessment of the congruence of clinical practice patterns with EORTC guidelines, is still in progress. Obviously, exploring the clinical value of the RESPOND system with an observational study or a cluster randomized controlled trial is an essential next step. However, many ethical questions need to be addressed before subjecting patients to clinical care based on the guidance of a decision-support tool that is not yet fully tested. More studies need to be done in regards to ESA dosing, as well as how accurately a computer system like RESPOND reflects the complexities of clinical treatment decisions. Furthermore, patient preferences in planning care must be considered, especially in the area of informed consent in evidence-based studies.

NAAC Expert Commentary:
The administration of erythropoietic stimulating agents (ESAs) in patients with cancer and chemotherapy-related anemia may present some risks, including deep vein thrombosis, pulmonary embolism and possibly enhanced tumor growth. To minimize these potential complications, it is important to administer ESAs within the restriction of professional guidelines. The assessment of guidelines adherence is a formidable challenge. Aapro and other investigators of the EORTC have generated a computer system that may guide the use of ESAs according to the EORTC guidelines. This article describes research to develop the program, called RESPOND.

Last Updated: October 9, 2007