There was no consistent relationship with factors such as disease-specific or generic instrument or the number of response options .
Negative changes were not associated with larger ESs .
Population -based estimation procedures and brief follow-up were associated with smaller ESs , and acute conditions with larger ESs .
Background .
A number of studies have computed the minimally important difference ( MID ) for health-related quality of life instruments .
To determine whether there is consistency in the magnitude of MID estimates from different instruments .
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 question naires , to measure the clinical effectiveness of therapeutic interventions . We aim ed to evaluate the previously vali date d Gastrointestinal Symptoms Rating Scale ( GSRS ) and the Quality of Life in Reflux and Dyspepsia ( QOLRAD ) question naires for reliability and responsiveness to change over time . METHODS : Patients ( n = 1143 ) with heartburn , but no esophagitis included in a r and omized clinical trial assessing the effectiveness of active treatment with proton pump inhibitors over 4 wk were evaluated . RESULTS : The test-retest reliability of both question naires over time was good to excellent ( GSRS 0.53–0.69 ; QOLRAD 0.65–0.76 ) , as was the responsiveness estimated by st and ardized 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 grade d 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 question naires that are reliable and sensitive to change . Both question naires should be suitable for use in clinical trials of therapeutic interventions for patients with heartburn
There was no consistent relationship with factors such as disease-specific or generic instrument or the number of response options .
Negative changes were not associated with larger ESs .
Population -based estimation procedures and brief follow-up were associated with smaller ESs , and acute conditions with larger ESs .
Background .
A number of studies have computed the minimally important difference ( MID ) for health-related quality of life instruments .
To determine whether there is consistency in the magnitude of MID estimates from different instruments .