scholarly journals GC-PROM: Validation of a patient-reported outcomes measure for Chinese patients with gastric cancer

2019 ◽  
Author(s):  
Xiaojuan Hu ◽  
Fen Zhao ◽  
Hongmei Yu ◽  
Yanhong Luo ◽  
Jinchun Liu ◽  
...  

Abstract Background: There is increasing recognition that PROs are important in the estimation of the burden of long-term survival among patients with gastric cancer. The study aimed to develop a disease-specific instrument to assess patient-reported outcomes for Chinese patients with gastric cancer. Method: Following the FDA’s draft guidance for patient-reported outcome, conceptual framework and item pool were defined based on relevant existing work. A draft scale was formed after revising some items based on feedback from experts and Chinese patients with gastric cancer. The pre-survey and formal survey were conducted in eight different hospitals in Shanxi Province, and two item-selection process based on classical test theory and item response theory. Finally, the patient-reported outcomes measure for Chinese patients with gastric cancer (GC-PROM) was validated in terms of reliability, validity, and feasibility. The minimal clinically important difference was determined by distribution-based method. Results: The final GC-PROM consisted of 38 items, 13 subdomains, and 4 domains. Reliability was verified by Cronbach’s alpha coefficient for four domains and 13 subdomains respectively. The validity results showed that the multidimensional scale fulfilled expectations. In the formal survey, the completion rate was 96.16%, and the average filling time was less than half an hour. The values of the minimal clinically important difference were 4.14, 3.41, 3.37, and 3.28 in the four domains. Conclusions: The GC-PROM had good reliability, validity, and feasibility and thus can be considered an effective clinical evaluation instrument for Chinese patients with gastric cancer.

2019 ◽  
Author(s):  
Xiaojuan Hu ◽  
Fen Zhao ◽  
Hongmei Yu ◽  
Yanhong Luo ◽  
Jinchun Liu ◽  
...  

Abstract Background: There is increasing recognition that PROs are important in the estimation of the burden of long-term survival among patients with gastric cancer. The study aimed to develop a disease-specific instrument to assess patient-reported outcomes for Chinese patients with gastric cancer. Method: Following the FDA's draft guidance for patient-reported outcome, conceptual framework and item pool were defined based on relevant existing work. A draft scale was formed after revising some items based on feedback from experts and Chinese patients with gastric cancer. The pre-survey and formal survey were conducted in eight different hospitals in Shanxi Province, and two item-selection process based on classical test theory and item response theory. Finally, the patient-reported outcomes measure for Chinese patients with gastric cancer (GC-PROM) was validated in terms of reliability, validity, and feasibility. The minimal clinically important difference was determined by distribution-based method. Results: The final GC-PROM consisted of 38 items, 13 subdomains, and 4 domains. Reliability was verified by Cronbach’s alpha coefficient for four domains and 13 subdomains respectively. The validity results showed that the multidimensional scale fulfilled expectations. In the formal survey, the completion rate was 96.16%, and the average filling time was less than half an hour. The values of the minimal clinically important difference were 4.14, 3.41, 3.37, and 3.28 in the four domains. Conclusions: The GC-PROM had good reliability, validity, and feasibility and thus can be considered an effective clinical evaluation instrument for Chinese patients with gastric cancer.


2019 ◽  
Author(s):  
Xiaojuan Hu ◽  
Fen Zhao ◽  
Hongmei Yu ◽  
Yanhong Luo ◽  
Jinchun Liu ◽  
...  

Abstract Background: There is increasing recognition that PROs are important in the estimation of the burden of long-term survival among patients with gastric cancer. The study aimed to develop a disease-specific instrument to assess patient-reported outcomes for Chinese patients with gastric cancer. Method: Following the FDA's draft guidance for patient-reported outcome, conceptual framework and item pool were defined based on relevant existing work. A draft scale was formed after revising some items based on feedback from experts and Chinese patients with gastric cancer. The pre-survey and formal survey were conducted in eight different hospitals in Shanxi Province, and two item-selection process based on classical test theory and item response theory. Finally, the patient-reported outcomes measure for Chinese patients with gastric cancer (GC-PROM) was validated in terms of reliability, validity, and feasibility. The minimal clinically important difference was determined by distribution-based method. Results: The final GC-PROM consisted of 38 items, 13 subdomains, and 4 domains. Reliability was verified by Cronbach’s alpha coefficient for four domains and 13 subdomains respectively. The validity results showed that the multidimensional scale fulfilled expectations. In the formal survey, the completion rate was 96.16%, and the average filling time was less than half an hour. The values of the minimal clinically important difference were 4.14, 3.41, 3.37, and 3.28 in the four domains. Conclusions: The GC-PROM had good reliability, validity, and feasibility and thus can be considered an effective clinical evaluation instrument for Chinese patients with gastric cancer.


2020 ◽  
Author(s):  
Xiaojuan Hu ◽  
Fen Zhao ◽  
Hongmei Yu ◽  
Yanhong Luo ◽  
Jinchun Liu ◽  
...  

Abstract Background: There is increasing recognition that PROs are important in the estimation of the burden of long-term survival among patients with gastric cancer. The study aimed to develop a disease-specific instrument to assess patient-reported outcomes for Chinese patients with gastric cancer. Method: Following the FDA’s draft guidance for patient-reported outcome, conceptual framework and item pool were defined based on relevant existing work. A draft scale was formed after revising some items based on feedback from experts and Chinese patients with gastric cancer. The pre-survey and formal survey were conducted in eight different hospitals in Shanxi Province, and two item-selection process based on classical test theory and item response theory. Finally, the patient-reported outcomes measure for Chinese patients with gastric cancer (GC-PROM) was validated in terms of reliability, validity, and feasibility. The minimal clinically important difference was determined by distribution-based method. Results: The final GC-PROM consisted of 38 items, 13 subdomains, and 4 domains. Reliability was verified by Cronbach’s alpha coefficient for four domains and 13 subdomains respectively. The validity results showed that the multidimensional scale fulfilled expectations. In the formal survey, the completion rate was 96.16%, and the average filling time was less than half an hour. The values of the minimal clinically important difference were 4.14, 3.41, 3.37, and 3.28 in the four domains. Conclusions: The GC-PROM had good reliability, validity, and feasibility and thus can be considered an effective clinical evaluation instrument for Chinese patients with gastric cancer.


2019 ◽  
Author(s):  
Xiaojuan Hu ◽  
Fen Zhao ◽  
Hongmei Yu ◽  
Yanhong Luo ◽  
Jinchun Liu ◽  
...  

Abstract Background: There is increasing recognition that PROs are important in the estimation of the burden of long-term survival among patients with gastric cancer. The study aimed to develop a disease-specific instrument to assess patient-reported outcomes for patients with gastric cancer. Method: Following the FDA's draft guidance for patient-reported outcome, conceptual framework and item pool were defined based on relevant existing work. A draft scale was formed after revising some items based on feedback from experts and patients with gastric cancer. The pre-survey and formal survey were conducted in eight different hospitals in Shanxi Province, and two item-selection process based on classical test theory and item response theory. Finally, the patient-reported outcomes measure for patients with gastric cancer (GC-PROM) was validated in terms of reliability, validity, and feasibility. The minimal clinically important difference was determined by distribution-based method. Results: The final GC-PROM consisted of 38 items, 13 subdomains, and 4 domains. Reliability was verified by Cronbach’s alpha coefficient for four domains and 13 subdomains respectively. The validity results showed that the multidimensional scale fulfilled expectations. In the formal survey, the completion rate was 96.16%, and the average filling time was less than half an hour. The values of the minimal clinically important difference were 4.14, 3.41, 3.37, and 3.28 in the four domains. Conclusions: The GC-PROM had good reliability, validity, and feasibility and thus can be considered an effective clinical evaluation instrument for patients with gastric cancer.


Neurosurgery ◽  
2016 ◽  
Vol 79 (1) ◽  
pp. 69-74 ◽  
Author(s):  
John A. Sielatycki ◽  
Chotai Silky ◽  
Kay Harrison ◽  
David Stonko ◽  
Matthew McGirt ◽  
...  

Abstract BACKGROUND Studies have investigated the impact of obesity in thoracolumbar surgery; however, the effect of obesity on patient-reported outcomes (PROs) following anterior cervical discectomy and fusion (ACDF) is unknown. OBJECTIVE To examine the relationship between obesity and PROs following elective ACDF. METHODS Consecutive patients undergoing ACDF for degenerative conditions were evaluated. Patients were divided into groups with a body mass index ≥35. The EuroQol-5D, Short-Form 12 (SF-12), modified Japanese Orthopaedic Association score, and Neck Disability Index were used. Correlations between PROs and obesity were calculated at baseline and 1 year. RESULTS A total of 299 patients were included, with 80 obese (27%) and 219 nonobese (73%). patients At baseline, obesity was associated with worse myelopathy (modified Japanese Orthopaedic Association score: 10.7 vs 12.2, P = .01), general physical health (SF-12 physical component scale score: 28.7 vs 31.8, P = .02), and general mental health (SF-12 mental component scale score: 38.9 vs 42.3, P = .04). All PROs improved significantly following surgery in both groups. There was no difference in absolute scores and change scores for any PRO at 12 months following surgery. Furthermore, there was no difference in the percentage of patients achieving a minimal clinically important difference for the Neck Disability Index (52% vs 56%, P = .51) and no difference in patient satisfaction (85% vs 85%, P = .85) between groups. CONCLUSION Obesity was not associated with less improvement in PROs following ACDF. There was no difference in the proportion of patients satisfied with surgery and those achieving a minimal clinically important difference across all PROs. Obese patients may therefore achieve meaningful improvement following elective ACDF.


BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Xiaojuan Hu ◽  
Fen Zhao ◽  
Hongmei Yu ◽  
Yanhong Luo ◽  
Jinchun Liu ◽  
...  

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