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01.04.2011 | Original Article

Measurement and Interpretation of Patient-Reported Outcomes in Surgery: An Opportunity for Improvement

verfasst von: Paul J. Karanicolas, Kai Bickenbach, Shiva Jayaraman, Andrea L. Pusic, Daniel G. Coit, Gordon H. Guyatt, Murray F. Brennan

Erschienen in: Journal of Gastrointestinal Surgery | Ausgabe 4/2011

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Abstract

Background

Surgery may have a profound effect on patients’ health-related quality of life (QOL). To be optimally useful, trials that seek to guide clinical decision making should measure outcomes that are important to patients and report the results in a clinically meaningful way. We sought to explore how researchers currently measure and interpret QOL in surgical trials, using gastric cancer as a case study.

Method

We performed a systematic review of randomized controlled trials (RCTs) of gastric cancer surgery published between 1966 and 2009 that included at least one patient-reported outcome (PRO). Investigators assessed trial eligibility and extracted data in duplicate using standardized forms, then resolved disagreements by consensus.

Results

Our search identified 87 RCTs of gastric cancer surgery, of which 11 (13%) included at least one PRO. Ten RCTs measured one or more validated PROs, although six also included ad hoc measures. All manuscripts presented the results as raw scores and nine of the 11 trials identified a statistical difference between groups. All 11 manuscripts prominently reported the PRO results in the abstracts and conclusions, but only one discussed the clinical significance of the differences between groups.

Conclusions

Most RCTs of gastric cancer surgery do not include measures of QOL and those that do suffer from important limitations. RCTs would be more useful to surgeons and patients if authors measured PROs and utilized existing approaches to present the results of PROs in ways that provide an intuitive sense of the magnitude of effects.

Orringer MB, Marshall B, Chang AC, Lee J, Pickens A, Lau CL. Two thousand transhiatal esophagectomies: changing trends, lessons learned. Ann Surg 2007;246(3): 363–372; discussion 372–364PubMedCrossRef

Winter JM, Cameron JL, Campbell KA, Arnold MA, Chang DC, Coleman J, Hodgin MB, Sauter PK, Hruban RH, Riall TS, Schulick RD, Choti MA, Lillemoe KD, Yeo CJ. 1423 pancreaticoduodenectomies for pancreatic cancer: A single-institution experience. J Gastrointest Surg 2006;10(9): 1199–1210; discussion 1210–1191PubMedCrossRef

House MG, Ito H, Gonen M, Fong Y, Allen PJ, DeMatteo RP, Brennan MF, Blumgart LH, Jarnagin WR, D'Angelica MI. Survival after hepatic resection for metastatic colorectal cancer: trends in outcomes for 1,600 patients during two decades at a single institution. J Am Coll Surg 2010;210(5): 744–752, 752–745PubMedCrossRef

Yopp AC, DeMatteo RP. Randomized clinical trials in surgical oncology. Preface. Surg Oncol Clin N Am 2010;19(1): xv–xvii.CrossRef

Blazeby JM, Avery K, Sprangers M, Pikhart H, Fayers P, Donovan J. Health-related quality of life measurement in randomized clinical trials in surgical oncology. Journal of Clinical Oncology 2006;24(19): 3178–3186.PubMedCrossRef

Efficace F, Bottomley A, Osaba D, Gotay C, Flechtner H, S Dh, 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? Journal of Clinical Oncology 2003;21(18): 3502–3511.PubMedCrossRef

Goodwin PJ, Black JT, Bordeleau LJ, Ganz PA. Health-related quality-of-life measurement in randomized clinical trials in breast cancer--taking stock. J Natl Cancer Inst 2003;95(4): 263–281.PubMedCrossRef

Bassler D, Busse JW, Karanicolas PJ, Guyatt GH. Evidence-based medicine targets the individual patient, part 1: how clinicians can use study results to determine optimal individual care. Evid Based Med 2008;13(4): 101–102.PubMedCrossRef

Bertuccio P, Chatenoud L, Levi F, Praud D, Ferlay J, Negri E, Malvezzi M, La Vecchia C. Recent patterns in gastric cancer: a global overview. Int J Cancer 2009;125(3): 666–673.PubMedCrossRef

10.

Yako-Suketomo H, Katanoda K. Comparison of time trends in stomach cancer mortality (1990–2006) in the world, from the WHO mortality database. Jpn J Clin Oncol 2009;39(9): 622–623.PubMedCrossRef

11.

Eagon JC, Miedema BW, Kelly KA. Postgastrectomy syndromes. Surgical Clinics of North America 1992;72(2): 445–465.PubMed

12.

Fein M, Fuchs K-H, Thalheimer A, Freys SM, Heimbucher J, Thiede A. Long-term benefits of Roux-en-Y pouch reconstruction after total gastrectomy: a randomized trial.[see comment]. Annals of Surgery 2008;247(5): 759–765.PubMedCrossRef

13.

Mezhir JJ, Pillarisetty VG, Shah MA, Coit DG. Randomized Clinical Trials in Gastric Cancer. Surgical Oncology Clinics of North America 2010;19(1): 81–100.PubMedCrossRef

14.

Karanicolas PJ, Bhandari M, Taromi B, Akl EA, Bassler D, Alonso-Coello P, Rigau D, Bryant D, Smith SE, Walter SD, Guyatt GH. Blinding of outcomes in trials of orthopaedic trauma: an opportunity to enhance the validity of clinical trials. J Bone Joint Surg Am 2008;90(5): 1026–1033.PubMedCrossRef

15.

Karanicolas PJ, Bhandari M, Walter SD, Heels-Ansdell D, Guyatt GH. Radiographs of hip fractures were digitally altered to mask surgeons to the type of implant without compromising the reliability of quality ratings or making the rating process more difficult. J Clin Epidemiol 2009;62(2): 214–223 e211.

16.

Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008;148(4): 295–309.PubMed

17.

Boutron I, Moher D, Tugwell P, Giraudeau B, Poiraudeau S, Nizard R, Ravaud P. A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensus. J Clin Epidemiol 2005;58(12): 1233–1240.PubMedCrossRef

18.

Moher D, Schulz K, Altman D. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001;357: 1191–1194.PubMedCrossRef

19.

Agha R, Cooper D, Muir G. The reporting quality of randomised controlled trials in surgery: a systematic review. Int J Surg 2007;5(6): 413–422.PubMedCrossRef

20.

Balasubramanian SP, Wiener M, Alshameeri Z, Tiruvoipati R, Elbourne D, Reed MW. Standards of reporting of randomized controlled trials in general surgery: can we do better? Ann Surg 2006;244(5): 663–667.PubMedCrossRef

21.

Jacquier I, Boutron I, Moher D, Roy C, Ravaud P. The reporting of randomized clinical trials using a surgical intervention is in need of immediate improvement: a systematic review. Ann Surg 2006;244(5): 677–683.PubMedCrossRef

22.

Sinha S, Ashby E, Jayaram R, Grocott MP. Quality of reporting in randomized trials published in high-quality surgical journals. J Am Coll Surg 2009;209(5): 565–571 e561.

23.

Pusic AL, Chen CM, Cano SJ, Klassen AF, McCarthy C, Collins ED, Cordeiro PG. Measuring quality of life in cosmetic and reconstructive breast surgery: A systematic review of patient-reported outcomes instruments. Plastic and Reconstructive Surgery 2007;120(4): 823–837.PubMedCrossRef

24.

Velikova G, Stark D, Selby P. Quality of life instruments in oncology. European Journal of Cancer 1999;35(11): 1571–1580.PubMedCrossRef

25.

King MT. The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30. Quality of Life Research 1996;5(6): 555–567.PubMedCrossRef

26.

Schunemann HJ, Guyatt GH. Goodbye M(C)ID! Hello MID, where do you come from? Health Serv Res 2005;40(2): 593–597.PubMedCrossRef

27.

Guyatt GH, Schunemann HJ. How can quality of life researchers make their work more useful to health workers and their patients? Quality of Life Research 2007;16: 1097–1105.PubMedCrossRef

28.

King MT, Fayers PM. Making quality-of-life results more meaningful for clinicians. Lancet 2008;371: 709–710.PubMedCrossRef

29.

Fuchs KH, Thiede A, Engemann R, Deltz E, Stremme O, Hamelmann H. Reconstruction of the food passage after total gastrectomy: randomized trial. World Journal of Surgery 1995;19(5): 698–705; discussion 705–696PubMedCrossRef

30.

Hoksch B, Ablassmaier B, Zieren J, Muller JM. Quality of life after gastrectomy: Longmire's reconstruction alone compared with additional pouch reconstruction. World Journal of Surgery 2002;26(3): 335–341.PubMedCrossRef

31.

Horvath OP, Kalmar K, Cseke L, Poto L, Zambo K. Nutritional and life-quality consequences of aboral pouch construction after total gastrectomy: a randomized, controlled study. European Journal of Surgical Oncology 2001;27(6): 558–563.PubMedCrossRef

32.

Kim Y-W, Baik YH, Yun YH, Nam BH, Kim DH, Choi IJ, Bae J-M. Improved quality of life outcomes after laparoscopy-assisted distal gastrectomy for early gastric cancer: results of a prospective randomized clinical trial. Annals of Surgery 2008;248(5): 721–727.PubMedCrossRef

33.

Kono K, Iizuka H, Sekikawa T, Sugai H, Takahashi A, Fujii H, Matsumoto Y. Improved quality of life with jejunal pouch reconstruction after total gastrectomy. American Journal of Surgery 2003;185(2): 150–154.PubMedCrossRef

34.

Schwarz A, Buchler M, Usinger K, Rieger H, Glasbrenner B, Friess H, Kunz R, Beger HG. Importance of the duodenal passage and pouch volume after total gastrectomy and reconstruction with the Ulm pouch: prospective randomized clinical study. World Journal of Surgery 1996;20(1): 60–66; discussion 66–67PubMedCrossRef

35.

Svedlund J, Sullivan M, Liedman B, Lundell L. Long term consequences of gastrectomy for patient's quality of life: the impact of reconstructive techniques. American Journal of Gastroenterology 1999;94(2): 438–445.PubMedCrossRef

36.

Troidl H, Kusche J, Vestweber KH, Eypasch E, Maul U. Pouch versus esophagojejunostomy after total gastrectomy: a randomized clinical trial. World Journal of Surgery 1987;11(6): 699–712.PubMedCrossRef

37.

Wu CW, Chiou JM, Ko FS, Lo SS, Chen JH, Lui WY, Whang-Peng J. Quality of life after curative gastrectomy for gastric cancer in a randomised controlled trial. British Journal of Cancer 2008;98(1): 54–59.PubMedCrossRef

38.

Zhang H, Sun Z, Xu H-M, Shan J-X, Wang S-B, Chen J-Q. Improved quality of life in patients with gastric cancer after esophagogastrostomy reconstruction. World Journal of Gastroenterology 2009;15(25): 3183–3190.PubMedCrossRef

39.

Blazeby JM, Conroy T, Bottomley A, Vickery C, Arraras J, Sezer O, Moore J, Koller M, Turhal NS, Stuart R, van Cutsem E, D'Haese S, Coens C. Clinical and psychometric validation of a questionnaire module, the EORTC QLQ-STO 22, to assess quality of life in patients with gastric cancer. European Journal of Cancer 2004;40(15): 2260–2268.PubMedCrossRef

40.

Vickery CW, Blazeby JM, Conroy T, Arraras J, Sezer O, Koller M, Rosemeyer D, Johnson CD, Alderson D. Development of an EORTC disease-specific quality of life module for use in patients with gastric cancer. European Journal of Cancer 2001;37(8): 966–971.PubMedCrossRef

41.

Eypasch E, Williams JI, Wood-Dauphinee S. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg 1995;82: 216–222.PubMedCrossRef

42.

Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci 1988;33(2): 129–134.PubMedCrossRef

Titel: Measurement and Interpretation of Patient-Reported Outcomes in Surgery: An Opportunity for Improvement
verfasst von: Paul J. Karanicolas
Kai Bickenbach
Shiva Jayaraman
Andrea L. Pusic
Daniel G. Coit
Gordon H. Guyatt
Murray F. Brennan
Publikationsdatum: 01.04.2011
Verlag: Springer-Verlag
Erschienen in: Journal of Gastrointestinal Surgery / Ausgabe 4/2011
Print ISSN: 1091-255X
Elektronische ISSN: 1873-4626
DOI: https://doi.org/10.1007/s11605-011-1421-1

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