Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders

Quality of Life Research

Volumn 13, Issue 10, 2004, Pages 1737-1749

  Rentz, A M ^a   Kahrilas, P ^b   Stanghellini, V ^c   Tack, J ^d   Talley, N J ^e   De La Loge, C ^f   Trudeau, E ^f   Dubois, D ^g   Revicki, D A ^h  

^a MEDTAP International Inc   (Germany)

^b NORTHWESTERN UNIVERSITY   (United States)

^c UNIVERSITY OF BOLOGNA   (Italy)

^d UNIVERSITY OF LEUVEN   (Belgium)

^e UNIVERSITY OF SYDNEY   (Australia)

^f MAPI VALUES   (United States)

^g JOHNSON AND JOHNSON   (United States)

^h UNITED BIOSOURCE CORPORATION   (United States)

Author keywords

Patient reported outcomes; Psychometric evaluation; Reliability; Symptoms; Validity

Indexed keywords

ABDOMINAL PAIN; ADULT; ARTICLE; BLOATING; CONTROLLED STUDY; CORRELATION COEFFICIENT; DISEASE SEVERITY; DYSPEPSIA; EVALUATION; FEMALE; FOOD REGURGITATION; GASTROESOPHAGEAL REFLUX; GASTROINTESTINAL SYMPTOM; HEARTBURN; HUMAN; INSTRUMENT; MAJOR CLINICAL STUDY; MALE; MEDICAL ASSESSMENT; NAUSEA AND VOMITING; PRIORITY JOURNAL; PSYCHOMETRY; QUESTIONNAIRE; REPRODUCIBILITY; SATIETY; SCORING SYSTEM; SELF REPORT; SHORT FORM 36; STOMACH PARESIS; ANALYSIS OF VARIANCE; CLASSIFICATION; CLINICAL TRIAL; EUROPE; HEALTH SURVEY; HOSPITALIZATION; MIDDLE AGED; MULTICENTER STUDY; QUALITY OF LIFE; SELF DISCLOSURE; VALIDATION STUDY;

ANALYSIS OF VARIANCE; DYSPEPSIA; EUROPE; FEMALE; GASTROESOPHAGEAL REFLUX; GASTROPARESIS; HEALTH STATUS INDICATORS; HUMANS; MALE; MIDDLE AGED; PSYCHOMETRICS; QUALITY OF LIFE; QUESTIONNAIRES; SELF DISCLOSURE; SEVERITY OF ILLNESS INDEX;

EID: 13844299543     PISSN: 09629343     EISSN: None     Source Type: Journal    
DOI: 10.1007/s11136-004-9567-x     Document Type: Article

References (54)

1. Drossman DA. Do the ROME criteria stand up? In: Goebell H, Holtmann G, Talley NJ (eds), Functional Dyspepsia and Irritable Bowel Syndrome: Concepts and Controversies, Dordrecht: Kluwer Academic Publishers, 1998, pp. 11-18.
2. Drossman DA, Corazziari E, Talley NJ, et al. Rome II: The Functional Gastrointestinal Disorders. 2nd ed. McLean, VA: Degnon Associates, 2000.
3. Talley NJ, Fullerton S, Junghard O, et al. Quality of life in patients with endoscopy-negative heartburn: Reliability and sensitivity of disease-specific instruments. Am J Gastroenterol 2002; 96: 1998-2004.
4. Havelund T, Lind T, Wiklund I, et al. Quality of life in patients with heartburn but without esophagitis: Effects of treatment with omeprazole. Am J Gastroenterol 1999; 94(7): 1782-1789.
5. Rentz AM, Battista C, Trudeau E, et al. Symptom and health-related quality-of-life measures for use in selected gastrointestinal disease studies: A review and synthesis of the literature. Pharmacoeconomics 2001; 19(4): 349-363.
6. Talley NJ, Haque M, Wyeth JW, et al. Development of a new dyspepsia impact scale: The Nepean Dyspepsia Index. Aliment Pharmacol Ther 1999; 13(2): 225-235.
7. Rabeneck L, Cook KF, Wristers K, et al. SODA (severity of dyspepsia assessment): A new effective outcome measure for dyspepsia-related health. J Clin Epidemiol 2001; 54(8): 755-765.
8. Leidy NK, Farup C, Rentz AM, et al. Patient-based assessment in dyspepsia: Development and validation of Dyspepsia Symptom Severity Index (DSSI). Dig Dis Sci 2000; 45(6): 1172-1179.
9. Moyer CA, Fendrick AM. Measuring health-related quality of life in patients with upper gastrointestinal disease. Dig Dis 1998; 16(5): 315-324.
10. Richter JE, Peura D, Benjamin SB, et al. Efficacy of omeprazole for the treatment of symptomatic acid reflux disease without esophagitis. Arch Intern Med 2000; 160(12): 1810-1816.
11. Velanovich V, Vallance SR, Gusz JR, et al. Quality of life scale for gastroesophageal reflux disease. J Am Coll Surg 1996; 183(3): 217-224.
12. Veldhuyzen van Zanten SJ, Tytgat KM, Pollak PT, et al. Can severity of symptoms be used as an outcome measure in trials of non-ulcer dyspepsia and Helicobacter pylori associated gastritis? J Clin Epidemiol 1993; 46(3): 273-279.
13. 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.
14. Revicki DA, Wood M, Wiklund I, et al. Reliability and validity of the Gastrointestinal Symptom Rating Scale in patients with gastroesophageal reflux disease. Qual Life Res 1998; 7(1): 75-83.
15. Rothman M, Farup C, Stewart W, et al. Symptoms associated with gastroesophageal reflux disease: Development of a questionnaire for use in clinical trials. Dig Dis Sci 2001; 46(7): 1540-1549.
16. Mansi C, Borro P, Giaeomini M, et al. Comparative effects of levosulpiride and cisapride on gastric emptying and symptoms in patients with functional dyspepsia and gastroparesis. Aliment Pharmacol Ther 2000; 14(5): 561-569.
17. Abell TL, Cutts TF, Cooper T. Effect of cisapride therapy for severe dyspepsia on gastrointestinal symptoms and quality of life. Scand J Gastroenterol Suppl 1993; 195: 60-63; discussion 63-64.
18. Garratt AM, Ruta DA, Russell I, et al. Developing a condition-specific measure of health for patients with dyspepsia and ulcer-related symptoms. J Clin Epidemiol 1996; 49(5): 565-571.
19. Horowitz M, Harding PE, Chatterton BE, et al. Acute and chronic effects of domperidone on gastric emptying in diabetic autonomic neuropathy. Dig Dis Sci 1985; 30(1): 1-9.
20. Jones KL, Wishart JM, Berry MK, et al. Effects of fedoto zine on gastric emptying and upper gastrointestinal symptoms in diabetic gastroparesis. Aliment Pharmacol Ther 2000; 14(7): 937-943.
21. Maton PN, Orlando R, Joelsson B. Efficacy of omeprazole versus ranitidine for symptomatic treatment of poorly responsive acid reflux disease - a prospective, controlled trial. Aliment Pharmacol Ther 1999; 13(6): 819-826.
22. Dekkers CP, Beker JA, Thjodleifsson B, et al. Double-blind comparison [correction of Double-blind, placebo-controlled comparison] of rabeprazole 20 mg vs. omeprazole 20 mg in the treatment of erosive or ulcerative gastrooesophageal reflux disease. The European Rabeprazole Study Group. Aliment Pharmacol Ther 1999; 13(1): 49-57.
23. Richter JE, Campbell DR, Kahrilas PJ, et al. Lansoprazole compared with ranitidine for the treatment of nonerosive gastroesophageal reflux disease. Arch Intern Med 2000; 160(12): 1803-1809.
24. Pass R, Murthy U, Hayden CW, et al. Omeprazole 40 mg once a day is equally effective as lansoprazole 30 mg twice a day in symptom control of patients with gastro-oesophageal reflux disease (GERD) who are resistant to conventional-dose lansoprazole therapy - a prospective, randomized, multi-centre study. Aliment Pharmacol Ther 2000; 14(12): 1595-1603.
25. Delchier JC, Cohen G, Humphries TJ. Rabeprazole, 20 mg once daily or 10 mg twice daily, is equivalent to omeprazole, 20 mg once daily, in the healing of erosive gastro oesophageal reflux disease. Scand J Gastroenterol 2000; 35(12): 1245-1250.
26. Richter JE, Kahrilas PJ, Johanson J, et al. Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis: A randomized controlled trial. Am J Gastroenterol 2001; 96(3): 656-665.
27. Cutts TF, Abell TL, Karas JG, et al. Symptom improvement from prokinetic therapy corresponds to improved quality of life in patients with severe dyspepsia. Dig Dis Sci 1996; 41(7): 1369-1378.
28. Soykan I, Sarosiek I, McCallum RW. The effect of chronic oral domperidone therapy on gastrointestinal symptoms, gastric emptying, and quality of life in patients with gastroparesis. Am J Gastroenterol 1997; 92(6): 976-980.
29. Silvers D, Kipnes M, Broadstone V, et al. Domperidone in the management of symptoms of diabetic gastroparesis: Efficacy, tolerability, and quality-of-life outcomes in a multicenter controlled trial. DOM-USA-5 Study Group. Clin Ther 1998; 20(3): 438-453.
30. Farup CE, Leidy NK, Murray M, et al. Effect of domperidone on the health-related quality of life of patients with symptoms of diabetic gastroparesis. Diabetes Care 1998; 21(10): 1699-1706.
31. Koch KL, Stern RM, Stewart WR, et al. Gastric emptying and gastric myoelectrical activity in patients with diabetic gastroparesis: Effect of long-term domperidone treatment. Am J Gastroenterol 1989; 84(9): 1069-1075.
32. Bullinger M, Anderson R, Cella D, et al. Developing and evaluating cross-cultural instruments from minimum requirements to optimal models. Qual Life Res 1993; 2(6): 451-459.
33. Acquadro C, Jambon B, Ellis D, et al. Language and translation issues. In: Spilker B (ed.), Quality of Life and Pharmacoeconomics in Clinical Trials. 2nd ed. Philadelphia: Lippincott-Raven, 1996, pp. 575-586.
34. Talley NJ, Stanghellini V, Heading RC, et al. Functional gastroduodenal disorders. Gut 1999; 45(Suppl 2): II37-1142.
35. Horowitz M, Fraser RJ. Gastroparesis: Diagnosis and management. Scand J Gastroenterol Suppl 1995; 213: 7-16.
36. Ware JE, Jr., Snow KK, Kosinski M, et al. Applications of the SF-36. SF-36 Health Survey: Manual and Interpretation Guide. Boston: The Health Institute, New England Medical Center, 1993, pp. 11:11-11:18.
37. Farup C, Kleinman L, Sloan S, et al. The impact of nocturnal symptoms associated with gastroesophageal reflux disease on health-related quality of life. Arch Intern Med 8 2001; 161(1): 45-52.
38. Prasad M, Rentz AM, Revicki DA. The impact of treatment for gastroesophageal reflux disease on health-related quality of life: A literature review. Pharmacoeconomics 2003; 21(11): 769-790.
39. Kaplan-Machlis B, Spiegler GE, Zodet MW, et al. Effectiveness and costs of omeprazole vs ranitidine for treatment of symptomatic gastroesophageal reflux disease in primary care clinics in West Virginia. Arch Fam Med 2000; 9(7): 624-630.
40. Revicki DA, Irwin D, Reblando J, et al. The accuracy of self-reported disability days. Med Care Apr 1994; 32(4): 401-404.
41. Broadhead WE, Blazer DG, George LK, et al. Depression, disability days, and days lost from work in a prospective epidemiologic survey. JAMA 1990; 264(19): 2524-2528.
42. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 1989; 10(4): 407-415.
43. Stanghellini V, Rentz AM, Schmier JK, et al. Mode of administration of the patient assessment of upper gastrointestinal disorders-symptom severity (PAGI-SYM) and patient assessment of upper gastrointestinal disorders-quality of life (PAGI-QOL). American College of Gastroenterology Annual Meeting, 2001.
44. Hambleton RK, Swaminathan H, Rogers HJ. Fundamentals of Item Response Theory. Newbury Park, CA: Sage Publications, 1991.
45. Cattell RB. The Scientific use of Factor Analysis in Behavioral and Life Sciences. New York: Plenum Press, 1978.
46. Cronbach L. Coefficient alpha and the internal structure of tests. Psychometrika 1951; 16: 297-334.
47. Hays RD, Anderson RT, Revicki DA. Assessing reliability and validity of measurement in clinical trials. In: Staquet MJ, Hays RD, Payers PM (eds), Quality of Life Assessment in Clinical Trials: Methods and Practice. Oxford: Oxford University Press, 1998.
48. Nunnally JC, Bernstein IH. Psychometric Theory. 3rd ed. New York: McGraw-Hill, 1994.
49. Revicki DA, Rentz AM, Dubois D, et al. Development and validation of a patient-assessed gastroparesis symptom severity measure: The Gastroparesis Cardinal Symptom Index (GCSI). Aliment Pharmacol Ther 2003; 18: 141-150.
50. Mertz H, Pass R, Kodner A, et al. Effect of amitriptyline on symptoms, sleep, and visceral perception in patients with functional dyspepsia. Am J Gastroenterol 1998; 93(2): 160-165.
51. Sturm A, Holtmann G, Goebell H, et al. Prokinetics in patients with gastroparesis: A systematic analysis. Digestion 1999; 60(5): 422-427.
52. Bolling-Sternevald E, Lauritsen K, Aalykke C, et al. Effect of profound acid suppression in functional dyspepsia: A double-blind, randomized, placebo-controlled trial. Scand J Gastroenterol 2002; 37(12): 1395-1402.
53. de la Loge C., Trudeau E., Marquis P., et al. Cross-cultural development and validation of a patient self-administered questionnaire to assess quality of life in upper gastrointestinal disorders: The PAGI-QOL. Qual Life Res 2004; 13(10): 1751-1762 (this issue).
54. Revicki DA, Rentz AM, Tack J, et al. Responsiveness and interpretation of the patient assessment of gastrointestinal symptom severity index. Clin Castro Hepat 2004; 2(9): 769-777.