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Introduction: As morbidity outcomes have significant limitations when comparing minimally invasive surgical procedures, recent trials reported on quality of life outcomes after different cholecystectomy procedures. These trials did not demonstrate differences of global quality of life instruments such as SF 36 at one month postoperatively. We wanted to test the performance of an NIH-sponsored Patient-Reported Outcomes Measures Information System (PROMIS) with previously validated, standardized PRO measures for use with minimally invasive procedures.
Methods: From May 2011 through Nov 2012, patients undergoing basic or advanced laparoscopic procedures agreed to participate in this IRB approved study. The PROMIS global health short form, validated for 7-day recall and previously used for 24-hour recall, the Linear Analog Self Assessment (LASA), validated for 24 hour recall and the 10 mm visual analog scale (VAS) for pain assessment were obtained preoperatively, 4hrs after surgery and on post-operative day 1 and 7. Each tool was scored and both the composite scores and single item responses were compared over time using the Kruskal Wallis test.
Results: Eighty-four patients, mean age 55, 56% female, mean BMI 31, were enrolled in the study. Preoperatively 81, and at postoperative time points 66, 59 and 59 patients provided scores for each question for analysis. The pain VAS scale revealed statistically and clinically significant differences from baseline (mean 1.8+ 2.4) to postoperative day one (mean 4.5+ 2.5) and 7 (mean 2.4+2.1) (p<0.0001). Overall scores did not reveal significant changes. The PROMIS physical subscale and physical T score revealed clinically and statistically significant differences from baseline (14.2 +2.9/46.8+7.7) to POD 1 (12.6+3/ 41.8+8.3) (p 0.0067/ 0.0038), driven by answers to a question about everyday physical activities (p=0.0001). The LASA scores revealed significant differences from baseline for pain frequency (p=0.0017) and severity (p= 0.0009) whereas fatigue was not different. When change from baseline within subject was assessed, 83% of subjects reported a clinically meaningful worsening in PROMIS physical T score on POD 1, which persisted in 73% of patients to POD 7. In addition to pain and LASA fatigue and social activity items were clinically worse in 20% of the patients at POD 7.
Conclusion: Overall quality of life scores with 7-day recall had limited discrimination for the impact of minimally invasive procedures. Single items appear more promising and change from baseline as a group and within subject revealed clinically significant fluctuation in QOL, especially within the first 7 days postop.