Abstract: Objective: To develop a Patient Self-regulation Ability Scale and to test its reliability and validity in patients with rectal cancer after sphincter-preserving surgery, so as to provide an evaluation tool for medical staff to measure the self-regulation ability of patients. Methods: Based on the definition of self-regulation described in the Integrated Theory of Health Behavior Change, combining literature analysis, expert consultations, pre-survey results, and group discussions, the Patient Self-regulation Ability Scale was developed. From August 2022 to March 2023, a total of 354 patients with rectal cancer undergoing sphincter-preserving surgery in the department of rectal surgery of two tertiary grade A hospitals in Beijing were selected by convenient sampling method to test the reliability and validity of the scale. Results: The Patient Self-regulation Ability Scale were with 17 items and 3 dimensions. The content validity index of the scale and item were both 1.00. Three common factors were extracted by exploratory factor analysis, and the cumulative variance contribution rate was 75.06%. Confirmatory factor analysis results showed that the fitting index of the scale structure model was good. Criterion validity was 0.580 (P<0.05). The overall Cronbach's α coefficient of the scale was 0.951 and the test-retest reliability was 0.958. Conclusion: The Patient Self-regulation Ability Scale has good reliability and validity, which is suitable to evaluate the self-regulation ability of patients.

Key words: patient self-regulation ability; scale development; reliability; validity; Integrated Theory of Health Behavior Change