ABSTRACT
Purpose@#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. Materials and Methods 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. @*Results@#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. Conclusion 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.
ABSTRACT
Purpose@#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. Materials and Methods 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. @*Results@#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. Conclusion 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.
ABSTRACT
Purpose@#Patients with gastric cancer who receive neoadjuvant therapy are staged before treatment (cStage) and after treatment (ypStage). We aimed to compare the prognostic reliability of cStage and ypStage, alone and in combination. @*Materials and Methods@#Data for all patients who received neoadjuvant therapy followed by surgery for gastric adenocarcinoma from 2004 to 2015 were extracted from the National Cancer Database. Kaplan-Meier (KM)curves were used to model overall survival based on cStage alone, ypStage alone, cStage stratified by ypStage, and ypStage stratified by cStage. P-values were generated to summarize the differences in KM curves. The discriminatory power of survival prediction was examined using Harrell's C-statistics. @*Results@#We included 8,977 patients in the analysis. As expected, increasing cStage and ypStage were associated with worse survival. The discriminatory prognostic power provided by cStage was poor (C-statistic 0.548), while that provided by ypStage was moderate (C-statistic 0.634). Within each cStage, the addition of ypStage information significantly altered the prognosis (P<0.0001 within cStages I–IV). However, for each ypStage, the addition of cStage information generally did not alter the prognosis (P=0.2874, 0.027, 0.061, 0.049, and 0.007 within ypStages 0–IV, respectively). The discriminatory prognostic power provided by the combination of cStage and ypStage was similar to that of ypStage alone (C-statistic 0.636 vs. 0.634). @*Conclusions@#The cStage is unreliable for prognosis, and ypStage is moderately reliable.Combining cStage and ypStage does not improve the discriminatory prognostic power provided by ypStage alone. A ypStage-based prognosis is minimally affected by the initial cStage.
ABSTRACT
Purpose@#Patients with gastric cancer who receive neoadjuvant therapy are staged before treatment (cStage) and after treatment (ypStage). We aimed to compare the prognostic reliability of cStage and ypStage, alone and in combination. @*Materials and Methods@#Data for all patients who received neoadjuvant therapy followed by surgery for gastric adenocarcinoma from 2004 to 2015 were extracted from the National Cancer Database. Kaplan-Meier (KM)curves were used to model overall survival based on cStage alone, ypStage alone, cStage stratified by ypStage, and ypStage stratified by cStage. P-values were generated to summarize the differences in KM curves. The discriminatory power of survival prediction was examined using Harrell's C-statistics. @*Results@#We included 8,977 patients in the analysis. As expected, increasing cStage and ypStage were associated with worse survival. The discriminatory prognostic power provided by cStage was poor (C-statistic 0.548), while that provided by ypStage was moderate (C-statistic 0.634). Within each cStage, the addition of ypStage information significantly altered the prognosis (P<0.0001 within cStages I–IV). However, for each ypStage, the addition of cStage information generally did not alter the prognosis (P=0.2874, 0.027, 0.061, 0.049, and 0.007 within ypStages 0–IV, respectively). The discriminatory prognostic power provided by the combination of cStage and ypStage was similar to that of ypStage alone (C-statistic 0.636 vs. 0.634). @*Conclusions@#The cStage is unreliable for prognosis, and ypStage is moderately reliable.Combining cStage and ypStage does not improve the discriminatory prognostic power provided by ypStage alone. A ypStage-based prognosis is minimally affected by the initial cStage.