Quality of life in patients with endoscopy-negative heartburn: reliability and sensitivity of disease-specific instruments

OBJECTIVES:Endoscopy-negative gastroesophageal reflux disease (GERD) lacks objective markers of disease severity. Evaluation of therapies for GERD must therefore rely on subjective measures, including patient self-report questionnaires, to measure the clinical effectiveness of therapeutic interventions. We aimed to evaluate the previously validated Gastrointestinal Symptoms Rating Scale (GSRS) and the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaires for reliability and responsiveness to change over time.METHODS:Patients (n = 1143) with heartburn, but no esophagitis included in a randomized clinical trial assessing the effectiveness of active treatment with proton pump inhibitors over 4 wk were evaluated.RESULTS:The test-retest reliability of both questionnaires over time was good to excellent (GSRS 0.53–0.69; QOLRAD 0.65–0.76), as was the responsiveness estimated by standardized response means (GSRS reflux dimension, −1.43; QOLRAD 0.81–1.43) and effect sizes (GRSR reflux dimension, −1.74; QOLRAD 0.82–1.56). The relationship between improvement in the GSRS reflux dimension score and the amount of clinical benefit as estimated by the patients themselves (based on the Overall Treatment Evaluation) suggested a minimally clinical relevant change is 0.5 on the seven graded scales applied. The importance rating indicated that an important change in the GSRS reflux dimension and the QOLRAD dimensions is equivalent to 1.0, and a very important change to 1.5.CONCLUSIONS:The GSRS and QOLRAD are valid questionnaires that are reliable and sensitive to change. Both questionnaires should be suitable for use in clinical trials of therapeutic interventions for patients with heartburn.

[1]  S. Oliveria,et al.  Heartburn risk factors, knowledge, and prevention strategies: a population-based survey of individuals with heartburn. , 1999, Archives of internal medicine.

[2]  W M Tierney,et al.  Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. , 1999, Medical care.

[3]  D A Revicki,et al.  Recommendations for evaluating the validity of quality of life claims for labeling and promotion. , 1999, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[4]  G. Guyatt,et al.  Methodological and statistical issues of quality of life (QoL) and economic evaluation in cancer clinical trials: report of a workshop. , 1998, European journal of cancer.

[5]  X. Badia,et al.  [Evaluation of quality of life in clinical trials]. , 1998, Medicina clinica.

[6]  P J Kahrilas,et al.  An evidence-based appraisal of reflux disease management — the Genval Workshop Report , 1998, Gut.

[7]  G. Guyatt,et al.  Interpreting treatment effects in randomised trials , 1998, BMJ.

[8]  A. Antinori,et al.  Defining and measuring quality of life in medicine. , 1998, JAMA.

[9]  I. Wiklund,et al.  Gastro‐oesophageal reflux disease in primary care: an international study of different treatment strategies with omeprazole , 1998 .

[10]  I. Wiklund,et al.  Quality of life during acute and intermittent treatment of gastro-oesophageal reflux disease with omeprazole compared with ranitidine. Results from a multicentre clinical trial. The European Study Group. , 1998, Italian journal of gastroenterology and hepatology.

[11]  A R Zinsmeister,et al.  Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. , 1997, Gastroenterology.

[12]  G. Guyatt,et al.  Assessing the minimal important difference in symptoms: a comparison of two techniques. , 1996, Journal of clinical epidemiology.

[13]  R. Jones,et al.  HEARTBURN, OESOPHAGITIS AND BARRETT'S OESOPHAGUS IN SELF‐MEDICATING PATIENTS IN GENERAL PRACTICE , 1996, The British journal of clinical practice.

[14]  A. Fletcher.  Measuring the effects of antihypertensive therapy upon the quality of life. , 1995, Current opinion in nephrology and hypertension.

[15]  I. Wiklund,et al.  Quality of life in patients with upper gastrointestinal symptoms. An improved evaluation of treatment regimens? , 1993, Scandinavian journal of gastroenterology.

[16]  J G Collins,et al.  Prevalence of selected chronic conditions: United States, 1986-88. , 1993, Vital and health statistics. Series 10, Data from the National Health Survey.

[17]  D. Spiegelhalter,et al.  Quality of life measures in health care. II: Design, analysis, and interpretation. , 1992, BMJ.

[18]  D. Spiegelhalter,et al.  Quality of life measures in health care. I: Applications and issues in assessment. , 1992, BMJ.

[19]  S. Ziebland,et al.  Importance of sensitivity to change as a criterion for selecting health status measures. , 1992, Quality in health care : QHC.

[20]  I. Wiklund,et al.  Evaluation of quality of life in clinical trials. Selecting quality-of-life measures. , 1991, Controlled clinical trials.

[21]  L. Bostad,et al.  Prevalences of endoscopic and histological findings in subjects with and without dyspepsia. , 1991, BMJ.

[22]  G. Guyatt,et al.  Measurement of health status. Ascertaining the minimal clinically important difference. , 1989, Controlled clinical trials.

[23]  F. Johnsson,et al.  Heartburn--the acid test. , 1989, Gut.

[24]  A. Stewart,et al.  Functional status and well-being of patients with chronic conditions. Results from the Medical Outcomes Study. , 1989, JAMA.

[25]  Lewis E. Kazis,et al.  Effect Sizes for Interpreting Changes in Health Status , 1989, Medical care.

[26]  W. Gregory,et al.  Who should measure quality of life, the doctor or the patient? , 1988, British Journal of Cancer.

[27]  J. Fleiss.  The design and analysis of clinical experiments , 1987 .

[28]  S. Harkins,et al.  Sensory-affective relationships among different types of clinical and experimental pain , 1987, Pain.

[29]  V. Stanghellini.  Three-month prevalence rates of gastrointestinal symptoms and the influence of demographic factors: results from the Domestic/International Gastroenterology Surveillance Study (DIGEST). , 1999, Scandinavian journal of gastroenterology. Supplement.

[30]  I. Wiklund,et al.  Quality of life in patients with heartburn but without esophagitis: effects of treatment with omeprazole , 1999, American Journal of Gastroenterology.

[31]  D. Osoba,et al.  Interpreting the significance of changes in health-related quality-of-life scores. , 1998, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[32]  I. Wiklund,et al.  Quality of Life in Reflux and Dyspepsia patients. Psychometric documentation of a new disease-specific questionnaire (QOLRAD). , 1998, The European journal of surgery. Supplement. : = Acta chirurgica. Supplement.

[33]  C. Bombardier,et al.  Evaluating changes in health status: reliability and responsiveness of five generic health status measures in workers with musculoskeletal disorders. , 1997, Journal of clinical epidemiology.

[34]  A. Hungin,et al.  Gastro-oesophageal reflux disease in primary care in Europe: Clinical presentation and endoscopic findings , 1995 .

[35]  R. Gelber,et al.  Quality-of-life assessment in clinical trials. , 1995, Cancer treatment and research.

[36]  G H Guyatt,et al.  Determining a minimal important change in a disease-specific Quality of Life Questionnaire. , 1994, Journal of clinical epidemiology.

[37]  J. Dent.  Long-term aims of treatment of reflux disease, and the role of non-drug measures. , 1992, Digestion.

[38]  William H. Rogers,et al.  Functional Status and Well-Being of Patients with Chronic Conditions , 1989 .

[39]  J. Collins.  Prevalence of selected chronic conditions: United States, 1990-1992. , 1997, Vital and health statistics. Series 10, Data from the National Health Survey.

[40]  B Kirshner,et al.  A methodological framework for assessing health indices. , 1985, Journal of chronic diseases.