Joseph A. Crawley

Treatment of chronic posterior laryngitis with esomeprazole

Objective: To evaluate the efficacy of acid‐suppressive therapy with the proton pump inhibitor esomeprazole on the signs and symptoms of chronic posterior laryngitis (CPL) in patients with suspected reflux laryngitis.

Effect of esomeprazole on nighttime heartburn and sleep quality in patients with GERD : A randomized, placebo-controlled trial

OBJECTIVES:Sleep disturbances are common in patients with gastroesophageal reflux disease (GERD). This study examined the effects of esomeprazole on nighttime heartburn, GERD-related sleep disturbances, sleep quality, work productivity, and regular activities.METHODS:This multicenter, randomized, double-blind, placebo-controlled trial included adults with GERD-associated sleep disturbances and moderate-to-severe nighttime heartburn (recorded by patient diary during screening). Patients received oral esomeprazole 40 mg (n = 220) or 20 mg (n = 226) or placebo (n = 229) once daily for 4 wk. The primary outcome was relief of nighttime heartburn. Secondary outcomes included resolution of sleep disturbances, sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire, and work productivity measured by the Work Productivity and Activity Impairment Questionnaire.RESULTS:Nighttime heartburn was relieved in 53.1% (111/209), 50.5% (111/220), and 12.7% (28/221) of patients who received esomeprazole 40 mg, esomeprazole 20 mg, and placebo, respectively. Differences (95% CI) versus placebo were 40.5% (32.4%, 48.5%) and 37.8% (29.9%, 45.7%) and were highly significant (p < 0.0001). GERD-related sleep disturbances resolved in significantly more (p < 0.0001) patients who received esomeprazole 40 (73.7%) or 20 mg (73.2%) than in those who received placebo (41.2%). Both esomeprazole groups had greater PSQI global score changes from baseline (p < 0.0001 vs placebo) and more (p < 0.0001 vs placebo) work hours saved per week per patient compared with baseline (esomeprazole 40 mg, 11.6 h; esomeprazole 20 mg, 12.3 h; placebo, 6.2 h).CONCLUSIONS:Esomeprazole reduced nighttime heartburn and GERD-related sleep disturbances and improved sleep quality and work productivity.

The burden of illness of gastro-oesophageal reflux disease: impact on work productivity.

Background:  The impact of gastro‐oesophageal reflux disease on work productivity has become increasingly important, as the symptoms of gastro‐oesophageal reflux disease affect individuals in their productive years of life.

A comparative trial of paper-and-pencil versus computer administration of the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire.

Background .Although most health-related quality of life questionnaires are self-administered by means of paper and pencil, new technologies for automated computer administration are becoming more readily available. Novel methods of instrument administration must be assessed for score equivalence in addition to consistency in reliability and validity. Objectives .The present study compared the psychometric characteristics (score equivalence and structure, internal consistency, and reproducibility reliability and construct validity) of the Quality of Life in Reflux And Dyspepsia (QOLRAD) questionnaire when self-administered by means of paper and pencil versus touch-screen computer. The influence of age, education, and prior experience with computers on score equivalence was also examined. Research Design .This crossover trial randomized 134 patients with gastroesophageal reflux disease to 1 of 2 groups: paper-and-pencil questionnaire administration followed by computer administration or computer administration followed by use of paper and pencil. To minimize learning effects and respondent fatigue, administrations were scheduled 3 days apart. A random sample of 32 patients participated in a 1-week reproducibility evaluation of the computer-administered QOLRAD. Results .QOLRAD scores were equivalent across the 2 methods of administration regardless of subject age, education, and prior computer use. Internal consistency levels were very high (&agr; = 0.93–0.99). Interscale correlations were strong and generally consistent across methods (r = 0.75–0.87). Correlations between the QOLRAD and Short Form 36 (SF-36) were high, with no significant differences by method. Test-retest reliability of the computer-administered QOLRAD was also very high (ICC = 0.93–0.96). Conclusions.Results of the present study suggest that the QOLRAD is reliable and valid when self-administered by means of computer touch-screen or paper and pencil.

The Impact of Laryngopharyngeal Reflux on Patient-Reported Quality of Life†

Objectives/Hypothesis The objectives were to assess patient‐reported outcomes, specifically, the health‐related quality of life of patients with laryngopharyngeal reflux, and to compare those reported levels with the health‐related quality of life of patients with gastroesophageal reflux disease and a general population.

The economic impact of GERD and PUD: examination of direct and indirect costs using a large integrated employer claims database

ABSTRACT Objective: The objective of this study was to examine the relationship of work loss associated with gastro-esophageal reflux disease (GERD) and peptic ulcer disease (PUD) in a large population of employed individuals in the United States (US) and quantify the economic impact of these diseases to the employer. Methods: A proprietary database that contained workplace absence, disability and workers’ compensation data in addition to prescription drug and medical claims was used to answer the objectives. Employees with a medical claim with an ICD-9 code for GERD or PUD were identified from 1 January 1997 to 31 December 2000. A cohort of controls was identified for the same time period using the method of frequency matching on age, gender, industry type, occupational status, and employment status. Work absence rates and health care costs were compared between the groups after adjusting for demographic, and employment differences using analysis of covariance models. Results: There were significantly lower ( p < 0.05) prescription, and outpatient costs in the controls compared to the disease groups, although the eta-square values were very low. The mean work absence attributed to sick days was 2.8 (± 2.3) for controls, 3.4 (± 2.5) for GERD, 3.2 (± 2.6) for PUD, and 3.2 (± 2.3) days for GERD + PUD. For work loss, a significantly higher ( p < 0.05) rate of adjusted all-cause absenteeism and sickness-related absenteeism were observed between the disease groups versus the controls. In particular, controls had an average of 1.2 to 1.6 days and 0.4 to 0.6 lower all-cause and sickness-related absenteeism compared to the disease groups. The incremental economic impact projected to a hypothetical employed population was estimated to be

Clinical trial: esomeprazole for moderate‐to‐severe nighttime heartburn and gastro‐oesophageal reflux disease‐related sleep disturbances

3441 for GERD,

Health-related quality of life improves with treatment-related GERD symptom resolution after adjusting for baseline severity

1374 for PUD, and

Simultaneous development of the Pediatric GERD Caregiver Impact Questionnaire (PGCIQ) in American English and American Spanish

4803 for GERD + PUD per employee per year compared to employees without these diseases. Conclusions: Direct medical cost and work absence in employees with GERD, PUD and GERD + PUD represent a significant burden to employees and employers.

User Preferences for Computer Administration of Quality of Life Instruments

Aliment Pharmacol Ther 2010; 32: 182–190