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.
Horowitz M, Fraser RJL. Gastroparesis: Diagnosis and management. Scand J Gastroenterol 1995; 30(Suppl 213): 7-16.
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.
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.
Horowitz M, Wishart JM, Jones KL, et al. Gastric emptying in diabetes: An overview. Diabetes Med 1996; 13(9 Suppl 5): S16-S22.
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.
Moyer CA, Fendrick AM. Measuring health-related quality of life in patients with upper gastrointestinal disease. Dig Dis 1998; 16: 315-324.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Jaeschke R, Singer J, Guyatt GH. Measurements of health status: Ascertaining the minimal clinically important difference. Control Clin Trials 1989; 10: 407-415.
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.
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.
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.
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.
Revicki DA, Irwin D, Reblando J, Simon GE. The accuracy of self-reported disability days. Med Care 1994; 32: 401-404.
Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care 1989; 27(3 Suppl): S178-S189.
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.
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.
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.
Nunnally JC, Bernstein IH. Psychometric Theory, 3rd ed. New York: McGraw-Hill, 1994.
Cohen J. Statistical Power Analysis for the Behavioral Sciences, 2nd ed. Hillsdale, NJ: Lawrence Erlbaum, 1988.
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.
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.
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.