Patients who have undergone gastrectomy have unique symptoms that are not appropriately assessed using currently available tools. This study developed and validated a symptom-focused quality of life ...(QoL) questionnaire for patients who have received gastrectomy for gastric cancer.
Based on a literature review, patient interviews, and expert consultation by the KOrean QUality of life in Stomach cancer patients Study group (KOQUSS), the initial item pool was developed. Two large-scale developmental studies were then sequentially conducted for exploratory factor analyses for content validity and item reduction. The final item pool was validated in a separate cohort of patients and assessed for internal consistency, test-retest reliability, construct validity, and clinical validity.
The initial questionnaire consisted of 46-items in 12 domains. Data from 465 patients at 11 institutions, followed by 499 patients at 13 institutions, were used to conduct item reduction and exploratory factor analyses. The final questionnaire (KOQUSS-40) comprised 40 items within 11 domains. Validation of KOQUSS-40 was conducted on 413 patients from 12 hospitals. KOQUSS-40 was found to have good model fit. The mean summary score of the KOQUSS-40 was correlated with the EORTC QLQ-C30 and STO22 (correlation coefficients, 0.821 and 0.778, respectively). The KOQUSS-40 score was also correlated with clinical factors, and had acceptable internal consistency (> 0.7). Test-retest reliability was greater than 0.8.
The KOQUSS-40 can be used to assess QoL of gastric cancer patients after gastrectomy and allows for a robust comparison of surgical techniques in clinical trials.
Aim : Acute isovolemic anemia is commonly observed after surgery and negatively influences shortand long-term outcomes. Current blood management practices fail to deliver effective reversal of ...anemia. The aim of this study was to evaluate the efficacy and safety of ferric carboxymaltose to treat anemia following gastrectomy. Method : The FAIRY study was a patient-blind, randomized, phase 3, placebo-controlled, 12- week study was conducted between 4 February 2013 and 15 December 2015 to evaluate the ability of ferric carboxymaltose to correct acute isovolemic anemia. This study was conducted in seven centers across the Republic of Korea. The primary endpoint was the number of hemoglobin responders, defined as hemoglobin increase of ≥2 g/dL from baseline and/or ≥11 g/dL at week 12. Secondary endpoints included changes in hemoglobin and other iron parameters over time, percentage of patients requiring alternative anemia management, and quality of life at weeks 3 and 12. Results : 454 patients were randomized to receive ferric carboxymaltose (228 patients) or placebo (226 patients). The number of hemoglobin responders was significantly greater for ferric carboxymaltose versus placebo (200 patients 92.2% vs 115 patients 54.0% ; 90 P=0.001). Correction of anemia and improvements in iron parameters were significantly in favor of ferric carboxymaltose at all time points, and these patients required less alternative anemia management compared to placebo patients (1.8% vs 7.1% ; P=0.006). Improvements were observed for fatigue and dyspnea in the ferric carboxymaltose group. No grade 3 or 4 adverse events were recorded, and ferric carboxymlatose-related adverse events reported in more than one patient included injection site reaction and urticaria (both : 5 patients 2.3%) Conclusions : Ferric carboxymlatose for postoperative blood management was safe and effective in correcting anemia and iron deficiency. In order to improve the recovery period, patients with low hemoglobin levels post-gastrectomy should receive intravenous ferric carboxymaltose.
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