A pilot study of patient-centered outcome assessment using PROMIS for patients undergoing colorectal surgery

Abstract

Purpose: Few studies have assessed patient-reported outcomes following colorectal surgery. The absence of this information makes it difficult to inform patients about the near-term effects of surgery, beyond outcomes assessed by traditional clinical measures. This study was designed to provide information about the effects of colorectal surgery on physical, mental, and social well-being outcomes.

Methods: The NIH Patient-Reported Outcomes Measurement Information System (PROMIS®) Assessment Center was used to collect patient responses prior to surgery and at their routine postoperative visit. Four domains were selected based on patient consultation and clinical experience: depression, pain interference, ability to participate in social roles and activities, and interest in sexual activity. Multilevel random coefficient models were used to assess the change in scores during the follow-up period and to assess the statistical significance of differences in trends over time associated with key clinical measures.

Results: In total, 142 patients were consented, with 107 patients completing pre- and postoperative assessments (75%). Preoperative assessments were typically completed 1 month prior to surgery (mean 29.5 days before, SD = 19.7) and postoperative assessments 1 month after surgery (mean 30.7 days after, SD = 9.2), with a mean of 60.3 days between assessment dates. Patients demonstrated no statistically significant changes in scores for pain interference (-0.18 points, p = 0.80) or the ability to participate in social roles and activities (0.44 points, p = 0.55), but had significant decreases in depression scores between pre- and postoperative assessments (-1.6 points, p = 0.03) and near significant increases in scores for interest in sex (1.5 points, p = 0.06). Pain interference scores for patients with neoadjuvant chemotherapy significantly increased (3.5 points, p = 0.03). Scores for the interest in sex domain decreased (worsened) for patients with oncologic etiology (-3.7 points, p = 0.03). No other differences in score trends by patient characteristics were large enough to be statistically significant at the p < 0.05 threshold.

Conclusion: These data suggest that the majority of patients quickly return to baseline physical, mental, and social function following colorectal surgery. This information can be used preoperatively to counsel patients about the typical impact of colorectal surgery on quality of life.

Keywords: Colorectal surgery; Enhanced recovery after surgery; PROMIS; Patient reported outcomes.

Fig. 1

Example level 1 and level 2 components of the combined equation represented in the multilevel random coefficient model

Fig. 2

Illustrates the flow of pre- and post-procedure assessments collected for consented patients and details the number of patients who completed assessments and who did not complete assessments at each stage

Fig. 3

Panel plot depicting the linear change in patient-reported outcome measure domain scores during the perioperative period. In each plot, the solid line depicts the multilevel random coefficient model estimated linear function for the monthly change in scores, with parallel dotted lines indicating the 95% confidence interval for the linear function estimates. Hatch marks plotted along the linear function identify points in time when assessments were recorded for individual patients

Fig. 4

Panel plot depicting the difference in the linear change in selected patient-reported outcome measure domain scores during the perioperative period, for four example groups. In each plot, the solid and dotted lines depict the multilevel random coefficient model estimated linear functions for the monthly change in scores, for specified groups. Hatch marks plotted along the linear function identify points in time when assessments were recorded for individual patients in each compared group