Promis for Basic Laparoscopy

Juliane Bingener, MD, Jeff Sloan, PhD, Paul Novotny, MS. Mayo Clinic

Background: Traditional physician reported outcomes (e.g. morbidity) have significant limitations when comparing minimally invasive surgical procedures. Interest in patient-reported outcomes (PRO), such as pain and fatigue, have led to an NIH sponsored Patient-Reported Outcomes Measures Information System (PROMIS). PRO supplement physician reported outcomes in some more chronic disease states and have been reliable predictors of survival in advanced lung cancer patients. We wanted to test the performance of these previously validated, standardized PRO measures for use with minimally invasive surgical procedures.

Methods: From May through August 2011, 20 patients undergoing basic 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.

Results: 21 patients underwent basic laparoscopic procedures (17 cholecystectomy, 3 diagnostic laparoscopy with biopsy and 1 cystic stump remnant resection) as outpatient procedures. Patients followed a standardized perioperative pain regimen with scheduled Acetaminophen, NSAIDS or Tramadol and weak opioids as necessary. For patients undergoing cholecystectomy the highest mean score was reported on postoperative day 1, (5.17; range 0-10), a 3 point increase from the baseline mean score of 2.06 (range 0-9). .
The PROMIS total-scores for mental and physical health did not vary over time. The single item PROMIS scores for social activity exhibited more movement from baseline around postoperative day 1 than the domains of pain, fatigue and physical activity. Changes from baseline in the LASA measurements were also noted on POD 1 in the domains of social activity, fatigue and pain, however not in overall physical health or physical activity. The VAS exhibited more change in scores than the pain items of the PROMIS or LASA tools. The pain score correlation (Bland Altman) was 0.82 for the PROMIS and LASA tools.
Conclusion: Overall quality of life scores with 7-day recall have limited utility for the evaluation of minimally invasive procedures. Single items with 7-day recall appear more promising. Evaluation of 24-hr recall for single items may be of value. Changes appear to occur from baseline to the first 24 hours.
 

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