Journal of Gastrointestinal Surgery

, Volume 19, Issue 5, pp 917–926 | Cite as

PROMIS for Laparoscopy

  • Juliane Bingener
  • Jeff A. Sloan
  • Drew K. Seisler
  • Andrea L. McConico
  • Pamela E. Skaran
  • David R. Farley
  • Mark J. Truty
Original Article



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.


From May 2011 through December 2013, patients undergoing laparoscopy responded to patient reported outcome questionnaires perioperatively. Composite and single item scores were compared.


One hundred fifteen patients, mean age 55 years, 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.


Single items and change from baseline are responsive perioperative quality of life assessments for laparoscopy.


Patient reported outcome Laparoscopy Pain Fatigue Quality of life Social activity 



Research reported in this manuscript was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under award number K23DK93553 and the National Cancer Institute CA154537-01A1-03 and UL1 TR000135. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the National Cancer Institute.


  1. 1.
    Horstmann R, Hellwig M, Classen C, Rottgermann S, Palmes D. Impact of polypropylene amount on functional outcome and quality of life after inguinal hernia repair by the TAPP procedure using pure, mixed, and titanium-coated meshes. World J Surg 2006;30: 1742–1749.CrossRefPubMedGoogle Scholar
  2. 2.
    Gholghesaei M, Langeveld HR, Veldkamp R, Bonjer HJ. Costs and quality of life after endoscopic repair of inguinal hernia versus open tension-free repair: a review. Surg Endosc 2005;19: 816–821.CrossRefPubMedGoogle Scholar
  3. 3.
    Barkun JS, Wexler MJ, Hinchey EJ, Thibeault D, Meakins JL. Laparoscopic versus open inguinal herniorrhaphy: preliminary results of a randomized controlled trial. Surgery 1995;118(4): 703–709; discussion 709–710.CrossRefPubMedGoogle Scholar
  4. 4.
    Snyder CW, Graham LA, Vick CC, Gray SH, Finan KR, Hawn MT. Patient satisfaction, chronic pain, and quality of life after elective incisional hernia repair: effects of recurrence and repair technique. Hernia 2011;15(2): 123–129.CrossRefPubMedGoogle Scholar
  5. 5.
    Langeveld HR, van’t Riet M, Weidema WF, Stassen LP, Steyerberg EW, Lange J, Bonjer HJ, Jeekel J. Total extraperitoneal inguinal hernia repair compared with Lichtenstein (the LEVEL-Trial): a randomized controlled trial. Ann Surg 2010;251(5): 819–824.CrossRefPubMedGoogle Scholar
  6. 6.
    Lirici MM, Califano AD, Angelini P, Corcione F. Laparo-endoscopic single site cholecystectomy versus standard laparoscopic cholecystectomy: results of a pilot randomized trial. Am J Surg 2011;202(1): 45–52.CrossRefPubMedGoogle Scholar
  7. 7.
    Phillips MS, Marks JM, Roberts K, Tacchino R, Onders R, DeNoto G, Rivas H, Islam A, Soper N, Gecelter G, Rubach E, Paraskeva P, Shah S. Intermediate results of a prospective randomized controlled trial of traditional four-port laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy. Surg Endosc 2012;26(5): 1296–1303.CrossRefPubMedGoogle Scholar
  8. 8.
    Marks J, Tacchino R, Roberts K, Onders R, Denoto G, Paraskeva P, Rivas H, Soper N, Rosemurgy A, Shah S. Prospective randomized controlled trial of traditional laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy: report of preliminary data. Am J Surg 2011;201(3): 369–372; discussion 372–363.CrossRefPubMedGoogle Scholar
  9. 9.
    Ma J, Cassera MA, Spaun GO, Hammill CW, Hansen PD, Aliabadi-Wahle S. Randomized controlled trial comparing single-port laparoscopic cholecystectomy and four-port laparoscopic cholecystectomy. Ann Surg 2011;254(1): 22–27.CrossRefPubMedGoogle Scholar
  10. 10.
    Bucher P, Pugin F, Buchs NC, Ostermann S, Morel P. Randomized clinical trial of laparoendoscopic single-site versus conventional laparoscopic cholecystectomy. Br J Surg 2011;98(12): 1695–1702.CrossRefPubMedGoogle Scholar
  11. 11.
    Leung D, Denham W, Salabat M, Butt Z, Barrera E, Ujiki M. Single-incision laparoscopic cholecystectomy results in similar short-term postoperative pain and quality of life scores when compared to multi-incision: A prospective randomized blinded comparison. Surgical Endsocopy and Other Interventional Techniques 2011;25(S239).Google Scholar
  12. 12.
    Garcia SF, Cella D, Clauser SB, Flynn KE, Lad T, Lai JS, Reeve BB, Smith AW, Stone AA, Weinfurt K. Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative. J Clin Oncol 2007;25(32): 5106–5112.CrossRefPubMedGoogle Scholar
  13. 13.
    Locke DE, Decker PA, Sloan JA, Brown PD, Malec JF, Clark MM, Rummans TA, Ballman KV, Schaefer PL, Buckner JC. Validation of single-item linear analog scale assessment of quality of life in neuro-oncology patients. J Pain Symptom Manage 2007;34(6): 628–638.CrossRefPubMedCentralPubMedGoogle Scholar
  14. 14.
    Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377–81.Google Scholar
  15. 15.
    Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003;41(5): 582–592.PubMedGoogle Scholar
  16. 16.
    Norman GR, Sloan JA, Wyrwich KW. The truly remarkable universality of half a standard deviation: confirmation through another look. Expert Rev Pharmacoecon Outcomes Res 2004;4(5): 581–585.CrossRefPubMedGoogle Scholar
  17. 17.
    Sloan JA, Symonds T, Vargar-Chanes D, Friedly B. Practical guidelines for assessing the clinical significance of health-related quality of life changes within clinical trials. Drug Inf J 2003;37: 23–31.Google Scholar
  18. 18.
    Neben-Wittich MA, Atherton PJ, Schwartz DJ, Sloan JA, Griffin PC, Deming RL, Anders JC, Loprinzi CL, Burger KN, Martenson JA. Comparison of provider-assessed and patient-reported outcome measures of acute skin toxicity during a phase III trial of mometasone cream versus placebo during breast radiotherapy: The North Central Cancer Treatment Group (N06C4). Int J Radiat Oncol Biol Phys 2010: 397–402.Google Scholar
  19. 19.
    Arndt V, Merx H, Stegmaier C, Ziegler H, Brenner H. Quality of life in patients with colorectal cancer 1 year After diagnosis compared with the general population: a population-based study. J Clin Oncol 2004;22(23): 4829–4836.CrossRefPubMedGoogle Scholar
  20. 20.
    Sloan JA, Zhao X, Novotny PJ, Wampfler J, Garces Y, Clark MM, Yang P. Relationship between deficits in overall quality of life and non-small-cell lung cancer survival. J Clin Oncol 2012;30(13): 1498–1504.CrossRefPubMedCentralPubMedGoogle Scholar
  21. 21.
    Velanovich V. The association of quality-of-life measures with malignancy and survival in patients with pancreatic pathology. Pancreas 2011;40(7): 1063–1069.CrossRefPubMedGoogle Scholar
  22. 22.
    Lee V, Cheng H, Li G, Saif MW. Quality of life in patients with pancreatic cancer. Journal of the Pancras 2012;13(2): 182–184.Google Scholar
  23. 23.
    Schnadig ID, Fromme EK, Loprinzi CL, Sloan JA, Mori M, Li H, Beer TM. Patient-physician disagreement regarding performance status is associated with worse survivorship in patients with advanced cancer. Cancer 2008;113(8): 2205–2214.CrossRefPubMedCentralPubMedGoogle Scholar
  24. 24.
    Qi Y, Schild SE, Mandrekar SJ, Tan AD, Krook JE, Rowland KM, Garces YI, Soori GS, Adjei AA, Sloan JA. Pretreatment quality of life is an independent prognostic factor for overall survival in patients with advanced stage non-small cell lung cancer. J Thorac Oncol 2009;4(9): 1075–1082.CrossRefPubMedCentralPubMedGoogle Scholar
  25. 25.
    Nelson H, Sargent D, Wieand HS, Group fCOoSTCS. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med 2004;350: 2050–2059.CrossRefGoogle Scholar
  26. 26.
    Stucky CC, Pockaj BA, Novotny PJ, Sloan JA, Sargent DJ, O’Connell MJ, Beart RW, Skibber JM, Nelson H, Weeks JC. Long-term follow-up and individual item analysis of quality of life assessments related to laparoscopic-assisted colectomy in the COST trial 93-46-53 (INT 0146). Ann Surg Oncol 2011;18(9): 2422–2431.CrossRefPubMedCentralPubMedGoogle Scholar
  27. 27.
    Weeks JC, Nelson H, Gelber S, Sargent D, Schroeder G. Short-term quality-of-life outcomes following laparoscopic-assisted colectomy vs open colectomy for colon cancer: a randomized trial. JAMA 2002;287(3): 321–328.CrossRefPubMedGoogle Scholar
  28. 28.
    Efficace F, Bottomley A, Osoba D, Gotay C, Flechtner H, D’Haese S, Zurlo A. Beyond the development of health-related quality-of-life (HRQOL) measures: a checklist for evaluating HRQOL outcomes in cancer clinical trials--does HRQOL evaluation in prostate cancer research inform clinical decision making? . J Clin Oncol 2003;21: 3502–3511.Google Scholar
  29. 29.
    Joly F, Vardy J, Pintilie M, Tannock IF. Quality of life and/or symptom control in randomized clinical trials for patients with advanced cancer. Ann Oncol 2007;18: 1935–1942.CrossRefPubMedGoogle Scholar

Copyright information

© The Society for Surgery of the Alimentary Tract 2015

Authors and Affiliations

  • Juliane Bingener
    • 1
  • Jeff A. Sloan
    • 1
    • 2
  • Drew K. Seisler
    • 2
  • Andrea L. McConico
    • 1
  • Pamela E. Skaran
    • 1
  • David R. Farley
    • 1
  • Mark J. Truty
    • 1
  1. 1.Department of SurgeryMayo ClinicRochesterUSA
  2. 2.Department of Health Sciences ResearchMayo ClinicRochesterUSA

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