A novel data collection and monitoring system for health status measures in patients undergoing lateral internal sphincterotomy: The Knowledge Program (TKP).

BACKGROUND/OBJECTIVE: The Knowledge Program (TKP) allows prospective data collection during routine clinical practice. The aim of this study was to evaluate the efficacy and feasibility of TKP for capturing and monitoring health status measures in patients undergoing lateral internal sphincterotomy (LIS).

METHODS: TKP data of patients undergoing LIS from December 2008 to May 2013 were retrieved. Health status measures including the Cleveland Global Quality of Life (CGQL), European Quality of Life Index (EQ-5D), Fecal Incontinence Severity Index (FISI), anorectal pain scores, and satisfaction questions were evaluated in the study.

RESULTS: A total of 500 patients underwent LIS within the study period. Overall patient numbers responding to the health status measures in the pre- and postoperative period were as follows: CGQL: 112 preoperatively, 53 postoperatively; EQ-5D: 112 preoperatively, 55 postoperatively; FISI: 102 preoperatively, 30 postoperatively; and anorectal pain score: 107 preoperatively, 45 postoperatively. Among the responders, the number of patients who completed the health status measures both pre- and postoperatively was as follows: EQ-5D: 31, CGQL: 28, anorectal pain: 24, and FISI: 15. A total of 30 patients completed postoperative satisfaction and recommendation questions. Postoperative earliest (p = 0.02) and most recent (p = 0.01) anorectal pain visual analog scores were significantly lower than the preoperative measurements. The earliest postoperative EQ-5D scores were significantly higher than their preoperative values (p = 0.02). The majority of patients who completed the surveys said they were satisfied (70% and 67%) and would recommended (73% and 70%) LIS to others undergoing postoperative earliest and most recent follow up.

CONCLUSION: LIS reduces anorectal pain without worsening quality of life. TKP captures information directly from patients and records it to a database which may reduce the risk of information loss or alteration.