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Published in: Journal of Gastrointestinal Surgery 5/2015

01-05-2015 | Original Article

PROMIS for Laparoscopy

Authors: Juliane Bingener, Jeff A. Sloan, Drew K. Seisler, Andrea L. McConico, Pamela E. Skaran, David R. Farley, Mark J. Truty

Published in: Journal of Gastrointestinal Surgery | Issue 5/2015

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Abstract

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 May 2011 through December 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 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.

Conclusion

Single items and change from baseline are responsive perioperative quality of life assessments for laparoscopy.
Literature
1.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
2.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
3.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
4.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
5.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
6.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
7.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
8.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
9.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
10.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
11.
go back to reference 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). 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).
12.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
13.
go back to reference 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.CrossRefPubMedCentralPubMed 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.CrossRefPubMedCentralPubMed
14.
go back to reference 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. 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.
15.
go back to reference 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.PubMed 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.PubMed
16.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
17.
go back to reference 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. 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.
18.
go back to reference 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. 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.
19.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
20.
go back to reference 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.CrossRefPubMedCentralPubMed 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.CrossRefPubMedCentralPubMed
21.
go back to reference Velanovich V. The association of quality-of-life measures with malignancy and survival in patients with pancreatic pathology. Pancreas 2011;40(7): 1063–1069.CrossRefPubMed Velanovich V. The association of quality-of-life measures with malignancy and survival in patients with pancreatic pathology. Pancreas 2011;40(7): 1063–1069.CrossRefPubMed
22.
go back to reference 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. 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.
23.
go back to reference 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.CrossRefPubMedCentralPubMed 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.CrossRefPubMedCentralPubMed
24.
go back to reference 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.CrossRefPubMedCentralPubMed 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.CrossRefPubMedCentralPubMed
25.
go back to reference 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.CrossRef 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.CrossRef
26.
go back to reference 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.CrossRefPubMedCentralPubMed 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.CrossRefPubMedCentralPubMed
27.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
28.
go back to reference 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. 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.
29.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
Metadata
Title
PROMIS for Laparoscopy
Authors
Juliane Bingener
Jeff A. Sloan
Drew K. Seisler
Andrea L. McConico
Pamela E. Skaran
David R. Farley
Mark J. Truty
Publication date
01-05-2015
Publisher
Springer US
Published in
Journal of Gastrointestinal Surgery / Issue 5/2015
Print ISSN: 1091-255X
Electronic ISSN: 1873-4626
DOI
https://doi.org/10.1007/s11605-015-2789-0

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