Introduction We tested the responsiveness of the National Institutes of Health-sponsored Patient-Reported Outcomes Measures Information System (PROMIS) global health short form and a linear analog self-assessment for laparoscopy. Methods From 5/2011 through 12/2013, patients undergoing laparoscopy responded to patient reported outcome questionnaires perioperatively. Composite and single item scores were compared. Results One hundred fifteen patients, mean age 55, 58% female, were enrolled. Visual analog pain scores differed significantly from baseline (mean 1.7±2.3) to postoperative day 1 (mean 4.8±2.6) and 7 (mean 2.5±2.1) (p<0.0001). PROMIS physical subscale and total physical component subscore differed significantly from baseline (14.4±3.0/47.4±8.3) to postoperative day 1 (12.7±3.2/42.1±8.8) (p 0.0007/0.0003), due to everyday physical activities (p=0.0001). Linear analog self-assessment scores differed from baseline for pain frequency (p<0.0001), pain severity (p< 0.0001) and social activity (p=0.0052); 40% of subjects reported worsening in PROMIS physical T-score to postoperative day 1 and 25% to postoperative day 7. Linear analog self-assessment mental well-being scores were worse in 32% of patients at postoperative day 7, emotional well-being in 28%, social activity in 24% , and fatigue in 20% of patients. Conclusion Single items and change from baseline are responsive perioperative quality of life assessments for laparoscopy.

Background Traditional metrics of postoperative outcomes (morbidity and mortality) are not useful to compare minimally invasive procedures with each other. Patient reported outcomes, such as quality of life (QOL) scores, offer an alternative approach. Compared with a large body of data in cancer treatment, the responsiveness of these instruments for minimally invasive surgery is not well described. To better define expected differences, we analyzed the reported QOL outcomes in randomized, controlled trials (RCTs) comparing single and four-port laparoscopic cholecystectomy. Methods Searching Medline, Embase, Psychinfo, Scopus, and the Cochrane Library (1946 to Jan 2012), two independent reviewers identified RCTs comparing single with four-port cholecystectomy in adult patients using perioperative QOL assessments. The quality of the studies was assessed regarding trial design and QOL reporting. Rev-Man was used for mathematical analysis of the pooled outcome data using a random-effects model. Standardized mean difference estimation was utilized when pooling studies reporting different QOL tools. Statistical heterogeneity was assessed using χ2 and I2. Results Of 743 citations, 37 RCTs were identified. Five studies with a total of 502 patients compared single with four-port cholecystectomy on QOL and were included. Pooled analysis was performed using preoperative and 1-month postoperative outcomes. At 1 month postoperatively, the reported effect size of perioperative QOL changes was up to 5 points (~1/2 SD) on the global SF 12 score. The largest difference in change of perioperative physical functioning was 9.9 points (~1 SD). No difference between the treatments was demonstrated. Conclusions Reporting of QOL may improve the comparison of minimally invasive surgical procedures. This systematic review reports clinically important changes and did not demonstrate a difference between treatments at 1 month postoperatively. The optimal timing and trial design for QOL tools in this setting needs to be defined further.

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