Abstract
BackgroundThere 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instrument to assess patient-reported outcomes for Chinese patients with gastric cancer.MethodFollowing the FDA’s draft guidance for patient-reported outcome, conceptual framework and item pool were defined based on relevant existing work.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.ResultsThe 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.ConclusionsThe GC-PROM had good reliability, validity, and feasibility and thus can be considered an effective clinical evaluation instrument for Chinese patients with gastric cancer.
Highlights
There is increasing recognition that patient-reported outcomes (PROs) are important in the estimation of the burden of long-term survival among patients with gastric cancer
The final Gastric cancer (GC)-PROM consisted of 38 items, 13 subdomains, and 4 domains
Participant characteristics A total of 145 patients and 55 healthy subjects were included in the pre-survey
Summary
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. Gastric cancer (gastric carcinoma, GC) is a malignant tumor occurring in the epithelial tissue of the stomach. There are approximately 989,000 new patients with GC worldwide each year, but the incidence of the disease varies greatly by region [2]. The diagnosis and treatment of GC are developing, the 5year survival rate for patients with GC is only 20%. GC causes physical pain to patients, poor mental state, and enormous costs for many families, which reduce the Chinese patients’ quality of life (QoL). Many patients with GC are focusing more on how improving overall QoL [4]
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