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Development and Evaluation of a Patient-Reported Outcome (PRO) Scale for Breast Cancer

  • Zhang, Jun (Department of General Surgery, Nanjing Medical University Affiliated Cancer Hospital, Cancer Institute of Jiangsu Province) ;
  • Yao, Yu-Feng (Department of General Surgery, Nanjing Medical University Affiliated Cancer Hospital, Cancer Institute of Jiangsu Province) ;
  • Zha, Xiao-Ming (Department of Breast Surgery, The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital) ;
  • Pan, Li-Qun (Department of Breast Surgery, The First Affiliated Hospital with Nanjing Medical University of TCM, Jiangsu Province Hospital of TCM) ;
  • Bian, Wei-He (Department of Breast Surgery, The First Affiliated Hospital with Nanjing Medical University of TCM, Jiangsu Province Hospital of TCM) ;
  • Tang, Jin Hai (Department of General Surgery, Nanjing Medical University Affiliated Cancer Hospital, Cancer Institute of Jiangsu Province)
  • Published : 2016.01.11

Abstract

Background: This study was guided by principles of the theoretical system of evidence-based medicine. In particular, when searching for evidence of breast cancer, a measuring scale is an instrument for evaluating curative effects in accordance with the laws and characteristics of medicine and exploring the establishment of a system for medically assessing curative effects. At present, there exist few tools for evaluating curative effects. Patient-reported outcomes (PROs) refer to outcomes directly reported by patients (without input or explanations from doctors or other intermediaries) with respect to all aspects of their health. Data obtained from PROs provide evidence of treatment effects. Materials and Methods: In accordance with the tenets of theoretical medicine and ancient medical theory regarding breast cancer, principles for developing a PRO scale were established, and a theoretical model was developed and a literature review was performed, items from this pool were combined and split, and an initial scale was constructed. After a pilot survey and additional modifications, a pre-questionnaire scale was formed and used in a field investigation. After the application of statistical methods, the item pool was used to create a formal scale. The reliability, validity and feasibility of this formal scale were then assessed. Results: In a clinical investigation, 479 responses were recovered, with an acceptance rate of 95%. a combination of various methods was employed, and the items that were selected by all methods or more than half of the methods were employed in the questionnaire. In these cases, the screening methods were combined with certain features of the item, A total of four domains and 38 items were reserved. The reliability analysis indicated that the PRO scale was relatively reliable. Conclusions: Scientific assessment proved that the proposed scale exhibited good reliability and validity. This scale was readily accepted and could be used to assess the curative effects of medical therapy. However, given the limited scope of this investigation, the capacity for adapting this scale to incorporate other theories could not be determined.

Keywords

PRO scale;breast cancer;evaluation of clinical curative effect

Acknowledgement

Supported by : Natural Science Foundation of Anhui Province

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