RESUMO
Background Preoperative anemia is associated with an increased need for blood transfusion, complications, and prolonged hospital stay. Iron deficiency anemia (IDA) may be treated with oral or intravenous (IV) iron. IV iron repletes iron stores more rapidly. Its impact on perioperative blood transfusion, postoperative complications, patients' recovery, and long-term quality of life is unclear. Newer agents, such as ferric carboxymaltose (FCM), are costly but have higher maximum approved doses and a very low incidence of anaphylactic-type reactions. This study aims to explore the feasibility of a randomized control trial to compare the preoperative treatment of IDA with IV FCM versus oral ferrous fumarate, in patients undergoing elective major abdominal surgery. Experimental design This is an open-label pilot randomized controlled trial. A total of 30 adults with IDA scheduled for elective major abdominal surgery were recruited for the study. They were randomized into two groups to receive either oral iron or IV FCM. Primary outcomes are defined as the time from enrollment to study drug administration, recruitment rate, and follow-up rate up to three months. Secondary outcomes are hemoglobin rise from recruitment to surgery, perioperative blood transfusion, postoperative complications, EQ-5D-3L scores at baseline, and three months and adverse events related to IV FCM therapy. Results All patients received study drugs within five days of enrollment; 30 patients were recruited within four months, 15 patients in each group. Two in each group were withdrawn for surgery postponement. All patients were followed up for three months and there was no crossover of patients. Per protocol, analysis was performed. No severe adverse events related to IV FCM therapy occurred. Both groups had similar baseline characteristics, similar hemoglobin rise from enrollment to the day of surgery [0.2 (+1.6) g/dL in the FCM group and 0.8 (+0.7) g/dL in the Oral Iron group, p=0.3] and similar mean units of perioperative blood transfused (recruitment to discharge) per patient [1.3 (+ 2.1) in the FCM group and 0.9 (+1.3) in the Oral Iron group, p=0.6]. Postoperatively, there was a similar hospital length of stay [11.5 (+13.6 days) in the FCM group and 9.0 (+9.8 days) in the Oral Iron group, p=0.6]; there were similar postoperative complications as reflected by the average Comprehensive Complication Index [12.8 (+19.6) in the FCM group and 22.6 (+30.7) in the Oral Iron group, p=0.3]; similar postoperative health-related quality of life as reflected by mean EQ-5D-3L scores at one month [70.4 (+21.8) in the FCM group and 84.5 (+12.1) in the Oral Iron group] and three months [80.0 (+18.4) in the FCM group and 85.9 (+10.7) in the Oral Iron group]. Conclusions A full-scale randomized controlled trial to evaluate the effectiveness of preoperative IV FCM compared to oral iron in patients with IDA undergoing major abdominal surgery is feasible.
RESUMO
INTRODUCTION: The identification of population-level healthcare needs using hospital electronic medical records (EMRs) is a promising approach for the evaluation and development of tailored healthcare services. Population segmentation based on healthcare needs may be possible using information on health and social service needs from EMRs. However, it is currently unknown if EMRs from restructured hospitals in Singapore provide information of sufficient quality for this purpose. We compared the inter-rater reliability between a population segment that was assigned prospectively and one that was assigned retrospectively based on EMR review. METHODS: 200 non-critical patients aged ≥ 55 years were prospectively evaluated by clinicians for their healthcare needs in the emergency department at Singapore General Hospital, Singapore. Trained clinician raters with no prior knowledge of these patients subsequently accessed the EMR up to the prospective rating date. A similar healthcare needs evaluation was conducted using the EMR. The inter-rater reliability between the two rating sets was evaluated using Cohen's Kappa and the incidence of missing information was tabulated. RESULTS: The inter-rater reliability for the medical 'global impression' rating was 0.37 for doctors and 0.35 for nurses. The inter-rater reliability for the same variable, retrospectively rated by two doctors, was 0.75. Variables with a higher incidence of missing EMR information such as 'social support in case of need' and 'patient activation' had poorer inter-rater reliability. CONCLUSION: Pre-existing EMR systems may not capture sufficient information for reliable determination of healthcare needs. Thus, we should consider integrating policy-relevant healthcare need variables into EMRs.