Development And Evaluation Of Patient-reported Outcomes Instrument For Stomach Cancer

Objective:According to the principle and processes of PRO instrument which is made by U.S. Food and Drug Administration(FDA), from the perspective of patients, to develop an instrument based on patient-reported outcomes for stomach cancer patients of Shanxi Province by writing, screening and assessment the item. Method:The PRO instrument development standard and procedures were followed during the development of this scale. The framing theory and the item pool were formed after important information of stomach cancer was gained through reading previous document and literature, and through consulting patients. Then the draft scale was formed after the correction of items in the aspect of experts and patients. This scale was used for trial investigation in 8 different level hospitals of Shanxi, and the primary scale was formed according to the first items selection by using the classical test theory and item response theory(IRT). Then the massive investigation was carried out by the primary scale in the same eight hospitals. The final scale was formed by selecting the items once again using the same method. Finally, the reliability, validity, and feasibility of the final scale were checked. Results:Final “Stomach Cancer PRO Scale” consists of 57 items, 13 dimensions, and 4 domains. The physical field includes 23 items, which belong to four dimensions: abdominal symptoms, systemic symptoms, physical state, independence; the psychological field includes 15 items, which belong to three dimensions: anxiety, depression, pessimism; the social field includes 7 items, which belong to two dimensions: social support, social adaptation; the treatment field includes 12 items, which belong to four dimensions: effectiveness, satisfaction, compliance, drug side effects.Then the assessment of the reliability, validity and feasibility was conducted. Reliability: reliability was verified by Cronbach,s α coefficient with 0.946 of total scale. Validity:structural validity result showed that the multi-dimensional measurement of the scale fulfilled the expectation. Feasibility: among the sample survey of the stomach cancer patients, the scale copy acceptance rate was 93.40%, completion rate was 96.16%, and the average filling time was 15 minutes. Conclusion:The stomach cancer PRO scale has good reliability, validity and feasibility, thus can be considered as the clinical treatment evaluation instrument for peptic ulcer patients.