The reflux disease questionnaire: A measure for assessment of treatment response in clinical trials

Health and Quality of Life Outcomes

Volumn 6, Issue , 2008, Pages

  Shaw, Michael ^a   Dent, John ^b   Beebe, Timothy ^c   Junghard, Ola ^d   Wiklund, Ingela ^d   Lind, Tore ^d   Johnsson, Folke ^e  

^a UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

^b ROYAL ADELAIDE HOSPITAL   (Australia)

^c Mayo Clinic College of Medicine   (United States)

^d ASTRAZENECA R AND D   (Sweden)

^e LUND UNIVERSITY   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ESOMEPRAZOLE; PLACEBO; PROTON PUMP INHIBITOR;

ADULT; AGED; ARTICLE; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; CORRELATION COEFFICIENT; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DYSPEPSIA; EFFECT SIZE; FEMALE; GASTROESOPHAGEAL REFLUX; HEARTBURN; HUMAN; INTERNAL CONSISTENCY; MAJOR CLINICAL STUDY; MALE; NORWAY; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; REFLUX DISEASE QUESTIONNAIRE; RELIABILITY; SCORING SYSTEM; SWEDEN; SYMPTOMATOLOGY; TREATMENT RESPONSE; VALIDATION PROCESS; ANALYSIS OF VARIANCE; HOSPITALIZATION; MIDDLE AGED; MULTICENTER STUDY; PSYCHOLOGICAL ASPECT; PSYCHOMETRY; QUALITY OF LIFE; REPRODUCIBILITY; VALIDATION STUDY;

ADULT; ANALYSIS OF VARIANCE; FEMALE; GASTROESOPHAGEAL REFLUX; HUMANS; MALE; MIDDLE AGED; PSYCHOMETRICS; QUALITY OF LIFE; QUESTIONNAIRES; REPRODUCIBILITY OF RESULTS; SEVERITY OF ILLNESS INDEX;

EID: 44249104937     PISSN: None     EISSN: 14777525     Source Type: Journal    
DOI: 10.1186/1477-7525-6-31     Document Type: Article

References (17)

1. Dent J Armstrong D Delaney B Moayyedi P Talley NJ Vakil N Symptom evaluation in reflux disease: Workshop background, processes, terminology, recommendations, and discussion outputs Gut 2004, 53(Suppl IV):iV1-24. 10.1136/gut.2003.034272
2. U.S. Department of Health and Human Services, Food and Drug Administration Guidance for Industry. Patient reported outcome measures: use in medical product development to support labeling claims 2006. http://www.fda.gov/cder/guidance/5460dft.pdf (accessed 21 January 2008).
3. Shaw M Talley NJ Beebe T Rockwood T Carlsson R Adlis S Fendrick AM Jones R Dent J Bytzer P Initial validation of a diagnostic questionnaire for gastroesophageal reflux disease Am J Gastroenterol 2001, 96:52-57. 10.1111/j.1572-0241.2001.03451.x 11197287
4. Johnsson F Hatlebakk JG Klintenberg AC Román J Toth E Stubberöd A Falk A Edin R One-week esomeprazole treatment: An effective confirmatory test in patients with suspected gastroesophageal reflux disease Scand J Gastroenterol 2003, 38:354-359. 10.1080/ 00365520310002139 12739706
5. Johnsson F Hatlebakk JG Klintenberg AC Román J Symptom-relieving effect of esomeprazole 40 mg daily in patients with heartburn Scand J Gastroenterol 2003, 38:347-353. 10.1080/00365520310002157 12739705
6. Lundell LR Dent J Bennett JR Blum AL Armstrong D Galmiche J-P Johnson F Hongo M Richter JE Spechler SJ Tytgat GN Wallin L Endoscopic assessment of esophagitis: Clinical and functional correlates and further validation of the Los Angeles classification Gut 1999, 45:172-180. 1727604 10403727
7. Jaeschke R Singer J Guyatt G Measurement of health status. Ascertaining the minimal clinically important difference Control Clin Trials 1989, 10:407-415. 10.1016/0197-2456(89)90005-6 2691207
8. Juniper EF Guyatt GH Willan A Griffith LE Determining a minimal important change in a disease-specific quality of life questionnaire J Clin Epidemiol 1994, 47:81-87. 10.1016/0895-4356(94)90036-1 8283197
9. Lydick E Epstein RS Interpretation of quality of life changes Qual Life Res 1993, 2:221-226. 10.1007/BF00435226 8401458
10. Guillemin F Bombardier C Beaton D Cross-cultural adaptation of health-related quality of life measures: Literature review and proposed guidelines J Clin Epidemiol 1993, 46:1417-1432. 10.1016/ 0895-4356(93)90142-N 8263569
11. Guyatt GH Juniper EF Walter SD Griffith LE Goldstein RS Interpreting treatment effects in randomized trials BMJ 1998, 316:690-693. 1112685 9522799
12. Kazis LE Anderson JJ Meenan RF Effect sizes for interpreting changes in health status Med Care 1989, 27:S178-189. 10.1097/ 00005650-198903001-00015 2646488
13. Cronbach LJ Coefficient alpha and the internal structure of tests Psychometrika 1951, 16:297-334. 10.1007/BF02310555
14. Carmines EG Zeller RA Reliability and validity Assessment Sage University Paper series on Quantitative Applications in the Social Sciences, 07-17 London: Sage Publications 1979.
15. Cohen J Statistical power analysis for the behavioral sciences New York: Academy Press 1977.
16. McColl E Junghard O Wiklund I Revicki DA Assessing symptoms in gastroesophageal reflux disease: How well do clinicians' assessments agree with those of their patients? Am J Gastroenterol 2005, 100:11-18. 10.1111/j.1572-0241.2005.40945.x 15654774
17. Streiner DL Norman GR Health measurement scales: A practical guide to their development and use Oxford: Oxford University Press 2 1995.