Objective To develop a pancreatic enzyme replacement therapy (PERT) Compliance Scale for pancreatic exocrine insufficiency (PEI) patients, and to test its reliability and validity.

Methods The Knowledge, Attitude, Belief, Practice (KAP) model was used as the theoretical framework. The item pool was formed by literature review and group discussion, and the preliminary scale was formed after two rounds of Delphi expert consultations and two rounds of cognitive interviews. A total of 125 patients after pancreatic surgery were investigated with the preliminary scale. The items(3 indexes) were screened using critical ratio, correlation coefficient and Cronbach′s α coefficient. The PERT Compliance Scale for patients with PEI was finally formed and the reliability and validity were tested.

Results After two rounds of Delphi expert consultations and two rounds of cognitive interviews, the preliminary scale was formed including 3 dimensions and 22 items. The items were re-screened using the three indexes. Five items that failed to reach at least 2 indexes were cancelled. The scale with 3 dimensions and 17 items was finally formed. Exploratory factor analysis was performed. Three common factors with the characteristic root value greater than 1 were extracted and the contribution rate of the cumulative variance was 58.669%. After two rounds of Delphi expert consultations, the scale level content validity index was 0.968, the item level contentvalidity index was 0.889 to 1.000. Internal consistency showed that Cronbach′s αcoefficient of the total scale was 0.806, and retest reliability was 0.822.

Conclusion The PERT Compliance Scale for PEI patients after pancreatic surgery developed in this study has good reliability and validity, can reflect the compliance of PERT and can be used as an evaluation tool in clinical practice.