Quality of Life Research

, Volume 13, Issue 4, pp 833–844

Gastroparesis Cardinal Symptom Index (GCSI): Development and validation of a patient reported assessment of severity of gastroparesis symptoms

  • Dennis A. Revicki
  • Anne M. Rentz
  • Dominique Dubois
  • Peter Kahrilas
  • Vincenzo Stanghellini
  • Nicholas J. Talley
  • Jan Tack
Article

Abstract

Background: Patient-rated symptom assessments are needed for evaluating the effectiveness of medical treatments and for monitoring outcomes in gastroparesis. Objective: This paper summarizes the development and psychometric evaluation of a new instrument, the Gastroparesis Cardinal Symptom Index (GCSI), for assessing severity of symptoms associated with gastroparesis. Methods: The GCSI was based on reviews of the medical literature, patient focus groups, and interviews with clinicians. A sample of 169 patients with a documented diagnosis of gastroparesis participated in the psychometric evaluation study. Patients completed the GCSI, the SF-36 Health Survey, and disability days questions at baseline and after 8 weeks. A randomly selected sub-sample of 30 subjects returned at 2 weeks to assess test–retest reliability. Clinicians rated severity of symptoms, and both clinicians and patients rated change in gastroparesis-related symptoms over the 8 week study. Results: The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). Internal consistency reliability was 0.84 for the GCSI total score and ranged from 0.83 to 0.85 for the subscale scores. Two week test–retest reliability was 0.76 for the total score and ranged from 0.68 to 0.81 for subscale scores. Construct validity was supported, given that we observed significant relationships between clinician assessed symptom severity and GCSI total score, significant differences between gastroparesis and dyspepsia patients (n = 760) on GCSI total (p < 0.0001) and subscale scores (p < 0.03 to p < 0.0001), moderate and significant relationships between GCSI total and SF-36 scores, and significant associations between GCSI total score and reports of restricted activity and bed disability days. Patients with greater symptom severity, as rated by clinicians, reported more symptom severity on GCSI total score. GSCI total scores were responsive to changes in overall gastroparesis symptoms as assessed by clinicians (p < 0.0001) and patients (p= 0.0004). Conclusion: The findings of this study indicate that the GCSI is a reliable and valid instrument for measuring symptom severity in patients with gastroparesis.

Construct validity Gastroparesis Patient-reported outcomes Psychometric evaluation Reliability Symptoms 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Bytzer P, Talley NJ, Leemon M, et al. Prevalence of gastrointestinal symptoms associated with diabetes mellitus: A population-based survey of 15,000 adults. Arch Intern Med 2001; 161(16): 1989-1996.Google Scholar
  2. 2.
    Horowitz M, Fraser RJL. Gastroparesis: Diagnosis and management. Scand J Gastroenterol 1995; 30(Suppl 213): 7-16.Google Scholar
  3. 3.
    Frank L, Kleinman L, Ganoczy D, et al. Upper gastrointestinal symptoms in North America. Prevalence and relationship to healthcare utilization and quality of life. Dig Dis Sci 2000; 45: 809-818.Google Scholar
  4. 4.
    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: 976-980.Google Scholar
  5. 5.
    Horowitz M, Wishart JM, Jones KL, et al. Gastric emptying in diabetes: An overview. Diabetes Med 1996; 13(9 Suppl 5): S16-S22.Google Scholar
  6. 6.
    Leidy NK, Farup C, Rentz AM, Ganoczy D, Koch KL. Patient-based assessment in dyspepsia: Development and validation of Dyspepsia Symptom Severity Index (DSSI). Dig Dis Sci 2000; 45: 1172-1179.Google Scholar
  7. 7.
    Moyer CA, Fendrick AM. Measuring health-related quality of life in patients with upper gastrointestinal disease. Dig Dis 1998; 16: 315-324.Google Scholar
  8. 8.
    Rabeneck L, Cook KF, Wristers K, Souchek J, Menke T, Wray NP. SODA (severity of dyspepsia assessment): A new effective outcome measure for dyspepsia-related health. J Clin Epidemiol 2001; 54: 755-765.Google Scholar
  9. 9.
    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: 349-363.Google Scholar
  10. 10.
    Revicki DA, Sorensen S, Maton PN, Orlando RC. Healthrelated quality of life outcomes of omeprazole versus. ranitidine in poorly responsive symptomatic gastroesophageal reflux disease. Dig Dis 1998; 16: 284-291.Google Scholar
  11. 11.
    Horowitz M, Harding PE, Chatterton BE, Collins PJ, Shearman DJC. Acute and chronic effects of domperidone on gastric emptying in diabetic autonomic neuropathy. Dig Dis Sci 1985: 30: 1-9.Google Scholar
  12. 12.
    Jones KL, Wishart JM, Berry MK, et al. Effects of fedotozine on gastric emptying and upper gastrointestinal symptoms in diabetic gastroparesis. Aliment Pharmacol Ther 2000; 14: 937-943.Google Scholar
  13. 13.
    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. Clin Ther 1998; 20: 438-453.Google Scholar
  14. 14.
    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: 1699-1706.Google Scholar
  15. 15.
    Koch KL, Stern RM, Stewart WR, et al. Gastric emptying and gastric myoelectrical activity in patients with diabetic gastroparesis: Effect of long-term domperidone therapy. Am J Gastroenterol 1989; 84: 1069-1075.Google Scholar
  16. 16.
    Patterson D, Abell T, Rothstein R, et al. A double-blind multicenter comparison of domperidone and metoclopramide in the treatment of diabetic patients with symptoms of gastroparesis. Am J Gastroenterol 1999; 94: 1230-1234.Google Scholar
  17. 17.
    Talley NJ, Verlinden M, Greenen DJ, et al. Effects of a motilin receptor agonist (ABT-229) on upper gastrointestinal symptoms in type 1 diabetes mellitus: A randomized, double blind, placebo controlled trial. Gut 2001; 49: 395-401.Google Scholar
  18. 18.
    Rentz AM, Schmier J, De La Loge C, et al. Development and preliminary psychometric validation of the patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) in GI patients. Presented at the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research, Antwerp, Belgium, November 2000.Google Scholar
  19. 19.
    Schmier J, Rentz AM, De La Loge C, et al. Development and preliminary psychometric validation of the patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) in gastroparesis. Presented at the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research, Antwerp, Belgium, November 2000.Google Scholar
  20. 20.
    Acquadro C, Jambon B, Ellis D, Marquis P. Language and translation issues. In: Spilker B (ed.). Quality of Life and Pharmacoeconomics in Clinical Trials, 2nd ed. Philadelphia: Lippincott-Raven, 1996; 575-586.Google Scholar
  21. 21.
    Bullinger M, Anderson R, Cella D, Aaronson N. Developing and evaluating cross-cultural instruments from minimum requirements to optimal models. Qual Life Res 1993; 2: 451-459.Google Scholar
  22. 22.
    Coulie B, Camilleri M, Revicki D, Dubois D. Symptoms suggestive of pathophysiological disturbances provide a basis for novel classification of functional upper gastrointestinal disorders. Presented at Digestive Disease Week, San Francisco, California, May 2002.Google Scholar
  23. 23.
    Ware JE Jr, Snow KK, Kosinski M, Gandek B. SF-36 Health Survey: Manual and Interpretation Guide. Boston, Massachusetts: The Health Institute, New England Medical Center, 1993.Google Scholar
  24. 24.
    Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR. Methods to explain the clinical significance of health status measures. Mayo Clinic Proceed 2002; 77: 371-383.Google Scholar
  25. 25.
    Jaeschke R, Singer J, Guyatt GH. Measurements of health status: Ascertaining the minimal clinically important difference. Control Clin Trials 1989; 10: 407-415.Google Scholar
  26. 26.
    Juniper EF, Guyatt GH, Willian A, Griffith LE. Determining a minimal important change in a disease-specific quality of life questionnaire. J Clin Epidemiol 1994; 47: 81-87.Google Scholar
  27. 27.
    Ware JE Jr, Kosinski M, Keller SD. SF-36 Physical and Mental Health Summary Scales: A User's Manual. Boston, Massachusetts: The Health Institute, New England Medical Center, 1994.Google Scholar
  28. 28.
    Bityutskiy JP, Soykan I, McCallum RW. Viral gastroparesis: A subgroup of idiopathic gastroparesis — clinical characteristics and long-term outcomes. Am J Gastroenterol 1997; 92(9): 1501-1504.Google Scholar
  29. 29.
    Broadhead WE, Blazer DG, George LK, Tse CK. Depression, disability days, and days lost from work in a prospective epidemiologic survey. JAMA 1990; 264: 2524-2528.Google Scholar
  30. 30.
    Revicki DA, Irwin D, Reblando J, Simon GE. The accuracy of self-reported disability days. Med Care 1994; 32: 401-404.Google Scholar
  31. 31.
    Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care 1989; 27(3 Suppl): S178-S189.Google Scholar
  32. 32.
    Wyrwich KW, Nienaber NA, Tierney WM, Wolinsky FD. Linking clinical relevance and statistical significance in evaluating intraindividual changes in health-related quality of life. Med Care 1999a; 37: 469-478.Google Scholar
  33. 33.
    Wyrwich KW, Tierney WM, Wolinsky FD. Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. J Clin Epidemiol 1999b; 52: 861-873.Google Scholar
  34. 34.
    Hays RD, Anderson RT, Revicki DA. Assessing reliability and validity of measurement in clinical trials. In: Staquet MJ, Hays RD, Fayers PM (eds), Quality of Life Assessment in Clinical Trials: Methods and Practice, Oxford: Oxford University Press, 1998.Google Scholar
  35. 35.
    Nunnally JC, Bernstein IH. Psychometric Theory, 3rd ed. New York: McGraw-Hill, 1994.Google Scholar
  36. 36.
    Cohen J. Statistical Power Analysis for the Behavioral Sciences, 2nd ed. Hillsdale, NJ: Lawrence Erlbaum, 1988.Google Scholar
  37. 37.
    Chassany O, Sagnier P, Marquis P, Fullerton S, Aaronson N. For the European Regulatory Issues on Quality of Life Assessment Group. Patient-reported outcomes: The example of health-related quality of life — a European guidance document for the improved integration of health-related quality of life assessment in the drug regulatory process. Drug Inform J 2002; 36: 209-218.Google Scholar
  38. 38.
    Leidy NK, Revicki DA, Geneste B. Recommendations for evaluating the validity of quality of life claims for labeling and promotion. Value Health 1999; 2: 113-127.Google Scholar
  39. 39.
    Revicki DA, Osoba D, Fairclough D, et al. Recommendations on health-related quality of life research to support labeling and promotional claims in the United States. Qual Life Res 2000; 9: 887-900.Google Scholar

Copyright information

© Kluwer Academic Publishers 2004

Authors and Affiliations

  • Dennis A. Revicki
    • 1
  • Anne M. Rentz
    • 2
  • Dominique Dubois
    • 3
  • Peter Kahrilas
    • 4
  • Vincenzo Stanghellini
    • 5
  • Nicholas J. Talley
    • 6
  • Jan Tack
    • 7
  1. 1.Center for Health Outcomes ResearchMEDTAP International, Inc.BethesdaUSA
  2. 2.MEDTAP International, Inc.SindelfingenGermany
  3. 3.Johnson & Johnson Pharmaceutical Services, LLCBeerseBelgium
  4. 4.Division of GastroenterologyNorthwestern UniversityChicagoUSA
  5. 5.Department of Internal Medicine and GastroenterologyUniversity of BolognaBolognaItaly
  6. 6.Department of MedicineUniversity of SydneySydneyAustralia
  7. 7.Department of GastroenterologyUniversity of LeuvenLeuvenBelgium

Personalised recommendations