Skip to main content
SpringerLink
Log in

Symptoms Associated with Gastroesophageal Reflux Disease

  • Published:
Digestive Diseases and Sciences Aims and scope Submit manuscript

Abstract

Many persons who suffer from GERD report additional symptoms, e.g., chest pain, dyspepsia, dysphagia, that are often not measured in clinical trials even though they may be distressing to the GERD sufferer. The primary goal of this study was to develop and assess the psychometric characteristics of a new GERD symptom scale measuring frequency, severity, and distress. The GERD Symptom Assessment Scale (GSAS) was administered to a sample of 169 GERD sufferers at baseline and two weeks. Internal consistency, construct validity, and test–retest reliability were assessed. Responsiveness was evaluated using clinical trial data assessing drug efficacy. Results: Internal consistency was >0.80 for the symptom severity and distress scales. All three scales showed stability over two weeks (ICC >0.70). Both validity hypotheses were supported. Comparison of effect sizes showed the GSAS is sensitive to changes in severity of symptoms. In conclusion, the GSAS is a reliable, valid, and responsive measure of GERD symptoms.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Klauser A, Schindlbeck N, Muller-Lissner S: Symptoms in gastro-oesophageal reflux disease. Lancet 335:205–208, 1990

    Google Scholar 

  2. Gallup: Prevalence, behavior and knowledge of gastrointestinal disorders. Princeton, New Jersey Gallup Organization, April 1995.

    Google Scholar 

  3. Zhu H, Pace F, Sanglaletti O, Bianchi Porro G: Features of symptomatic gastroesophageal reflux in elderly patients. Scand J Gastroenterol 28:235–238, 1993.

    Google Scholar 

  4. Locke GR, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ III: Prevalence and clinical spectrum of gastroesophageal reflux: A population-based study in Olmstead County, Minnesota, Gastronterology 112:1448–1456, 1997

    Google Scholar 

  5. Heading R, Eaves N: Aims of treatment in gastroesophageal reflux disease. Front Gastrointest Res 20:1–10, 1992

    Google Scholar 

  6. Williford WO, Krol WF, Spechler SJ, VA Cooperative Study Group: Development for and results of the use of a gastroesophageal reflux disease activity index as an outcome variable in a clinical trial. Cont Clin Trials 15:335–348, 1994

    Google Scholar 

  7. Schipper H, Clinch J: Assessment of treatment in cancer. In Measuring Health: A Practical Approach. G Teeling-Smith (ed.) New York, Wiley, 1988, pp 109–155

    Google Scholar 

  8. Cella D, Tulsky D: Measuring quality of life today: Methodological aspects. Oncology 4:29–39, 1990

    Google Scholar 

  9. Young T, Kirchdoerfer L, Osterhaus J: Development and validation process for a disease-specific quality of life instrument. Drug Info J 30:185–193, 1996

    Google Scholar 

  10. Eypasch E, Williams J, Wood-Dauphinee S, Ure B, Schmulling C, Neugebauer E, Troidl: Gastrointestinal quality of life index: Development, validation and application of a new instrument. Brit J S 82:216–222, 1995

    Google Scholar 

  11. Mathias S, Castell D, Elkin E, Matosian M: Health-related quality of life of patients with acute erosive reflux esophagitis. Dig Dis Sci 41:2123–2129, 1996

    Google Scholar 

  12. Greatorex R, Thorpe J: Clinical assessment of gastrooesophageal reflux by questionnaire. B J of Clin Prac 37:133–135, 1983

    Google Scholar 

  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 33:129–134, 1988.

    Google Scholar 

  14. Dunlop GM: A study of the relative frequency and importance of gastrointestinal symptoms and weakness in patients with far-advanced cancer: Student paper. Palliat Med 4:37–43, 1990

    Google Scholar 

  15. McCorkle R, Young K: Development of a symptom distress scale. Cancer Nurs 1:373–378, 1978

    Google Scholar 

  16. Portenoy RK, Thaler HT, Kornblith AB, Lepore JM, Friedlander-Klar H, Kiyasu E, Sobel K, Coyle N, Kemeny N, Norton L, Scher H: The Memorial Symptom Assessment Scale: An instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer 30A:1326–1336, 1994

    Google Scholar 

  17. Locke GR, Talley NJ, Weaver AL, Zinsmeister AR. A new questionnaire for gastroesophageal reflux disease. Mayo Clin Proc 69:539–547, 1994

    Google Scholar 

  18. Heading RC. Epidemiology of oesophageal reflux disease. Scand J Gastroenterol 24(suppl 168):33–37, 1989

    Google Scholar 

  19. Dupuy HJ: The Psychological General Well-being (PGWB) index. In Assessment of Quality of Life in Clinical Trials of Cardiovascular Therapies. NK Wenger, ME Mattson, CF Furberg, J Elinson, (ed). New York, Le Jacq 1984, pp 170–183

    Google Scholar 

  20. Dimena¨s E, Glise H, Hallerba¨ck B, Hernqvist B, Svedlund J, Wiklund I: Quality of life in patients with upper gastrointestinal symptoms. An improved evaluation of treatment regimens? Scand J Gastroenterol 28:681–687, 1993

    Google Scholar 

  21. Dimenas E: Methodological aspects of evaluation of quality of life in upper gastrointestinal diseases. Scand J Gastroenterol 28(suppl 199):18–21, 1993

    Google Scholar 

  22. Glise H: Quality of life assessments in patients with peptic ulcer during treatment and follow-up. Scand J Gastroenterol 28(suppl 199):34–35, 1993

    Google Scholar 

  23. Glise H, Hallerback B, Johansson B: Quality of life assessment in an evaluation of laparascopic Rosetti fundoplication. Surg Endosc 9:183–189, 1995

    Google Scholar 

  24. Ware JE, Snow KK, Kosinski M, Gandek B: SF-36 Health Survey: Manual and Interpretation Guide Boston, The Health Institute, 1993

  25. Ware JE, Kosinski M, Keller SD: SF-36 physical and mental component summary measures–a user's manual. Boston, The Health Institute, 1994

    Google Scholar 

  26. Rush DR, Stelmach WJ, Young TL, Kirchdoerfer LJ, Scott-Lennox J, Holverson HE, Sabesin SM, Nicholas TA: Clinical effectiveness and quality of life with ranitidine vs placebo in gastroesophageal reflux disease patients. J of Family. Prac 41:125–136, 1995

    Google Scholar 

  27. Revicki DA, Wood M, Maton PN, Sorensen S: Impact of gastroesophageal reflux disease on health-related quality of life. Am J Med 104:000, 1998

    Google Scholar 

  28. Wu A, Revicki DA: Sexual relations scale. Bethesda, Maryland, MEDTAP International, 1995

    Google Scholar 

  29. Hays RD, Stewart AL: Sleep measures. In Measuring Functioning and Well-Being. AL Steward, JE Warc (ed.). Duke University Press; Durham North Carolina, 1993

    Google Scholar 

  30. Cronbach LJ: Coefficient alpha in the internal structure of tests. Psychometrika 15:297–334, 1951

    Google Scholar 

  31. Miner P, Sloan S, Filippone J, Zheng M, DeLoria C, Jokubaitis L: Significant heartburn relief after the first dose of rabeprazole sodium in non-erosive reflux disease (NERD) patients. Gastroenterology (in press)

  32. Cohen J: Statistical Power Analysis for the Behavioral Sciences, 2d ed. Hillsdale, New Jersey, Lawrence Erlbaum Assoc., 1998

    Google Scholar 

  33. Guyatt G, Walter S, Norman G: Measuring change over time: assessing the usefulness of evaluative instruments. Chron Dis 40:171, 1987

    Google Scholar 

  34. DeDombal FT, Softley A: IOIBD report no. 1: Observer variation in calculating indices of severity and activity in Crohn's disease. Gut 28:474–481, 1987

    Google Scholar 

  35. Weiss, CH: Interviewing in evaluation research. In Handbook of Evaluation Research. EL Struening, M Guttentag (eds). Beverly Hills, Sage Publications 1975, pp 355–395

    Google Scholar 

  36. Sattler J: Racial ‘experimenter effects’ in experimentation, interviewing and psychotherapy. Psychol Bull 73:137–160, 1970

    Google Scholar 

  37. Hutchinson TA, Boyd NF, Feinstein AR: Scientific problems in clinical scales, as demonstrated in the Karnofsky index of performance status. J Chron Dis 32:661–666, 1979

    Google Scholar 

  38. Fontaine A, Larue F: Physicians9 assessment of the symptoms experienced by their patients: Is it reliable? Med Decis Making Meeting 16;467, 1996

    Google Scholar 

  39. Osoba D: Lessons learned from measuring health-related quality of life in oncology. J Clin Oncol 12:608–616, 1994 40. Stephans R, Hopwood P, Girling D, Machin D: Randomized trials with quality of life endpoints: Are doctors9 ratings of patients9 physical symptoms interchangeable with patients9 self-ratings? Qual Life Res 6:225-236, 1997 41. Drossman DA, Patrick DL, Mitchell CM, Murp, Zagami EA, Appelbaum MI: Health related quality of life inflammatory bowel disease: functional status and patient worries and concerns. Dig Dis Sci 34:1379 -1386, 1989 42. Cook D, Guyatt G, Juniper E, Griffith L, McIlroy W, Willan A, Jaseschke R, Epstein R: Interviewer versus self-administered questionnaires in developing a disease-specific, health-related quality of life instrument for asthma. J Clin Epidemiol 46:529- 534, 1993 43. Bergner M, Bobbitt R, Carter W, Gilson B: The sickness impact profile: Development and final revision of a health status measure. Med Care 19:787- 805, 1981 44. Hyland ME, Kenyon CAP, Allen R, Howarth P: Diary keeping in asthma: Comparison of written and electronic methods. BMJ 306:487- 489, 1993 45. Bleehan NM, Girling DJ, Machin D, Stephens RJ: A randomized trial of three or six courses of etopside cyclophosphamide methotrexate and vincristine or six courses of etoposide and ifosfasmide in small cell lung cancer (SCLC). II Duality of Life. Medical Research Council Lung Cancer Working Party. Br J Cancer 68:1157-1166, 1993 46. Gold DR, Weiss ST, Tager IB, Segal MR, Speizer FE: Comparison of questionnaire and diary methods in acute childhood respiratory illness surveillance. Am Rev Respir Dis 139:847- 849, 1989 47. Neas LM, Dockery DW, Wypij D, Speizer FE, Ferris BG Jr: A comparison of the ATS-DLD Children's Questionnaire with a year-long daily diary of respiratory symptoms. Am Rev Respir Dis 143:A205, 1991 VALIDATION OF A GERD QUESTIONNAIRE 1549 Digestive Diseases and Sciences, Vol. 46, No. 7 (July 2001)

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Janssen Research Foundation, Titusville, New Jersey

    Margaret Rothman

  2. Janssen Pharmaceutica, Inc., Titusville, New Jersey

    Christina Farup

  3. Innovative Medical Research, Inc., Towson, Maryland

    Walter Stewart

  4. IBAH, Blue Bell, Pennsylvania

    Lawrence Helbers

  5. Celgene Corporation, Warren, New Jersey

    Jerome Zeldis

Authors
  1. Margaret Rothman
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Christina Farup
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Walter Stewart
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Lawrence Helbers
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Jerome Zeldis
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

Rothman, M., Farup, C., Stewart, W. et al. Symptoms Associated with Gastroesophageal Reflux Disease. Dig Dis Sci 46, 1540–1549 (2001). https://doi.org/10.1023/A:1010660425522

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1023/A:1010660425522

Search

Navigation