Development for and results of the use of a gastroesophageal reflux disease activity index as an outcome variable in a clinical trial

Williford, William O.; Król, W; Spechler, Stuart J.

doi:10.1016/0197-2456(94)90031-0

Cited by 41 publications

(29 citation statements)

References 16 publications

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“…The activity index was initially developed as a composite score solely for the purpose of use as a major outcome variable in a randomized clinical trial comparing the efficacy of medical and surgical treatment therapies in patients with GERD. It has now been established as a valid method by which treatment of GERD patients can be accurately and inexpensively evaluated (13).…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Long‐term results of quality of life after standard laparoscopic vs. robot‐assisted laparoscopic fundoplications for gastro‐oesophageal reflux disease. A comparative clinical trial

Hartmann

Menenakos

Ordemann

et al. 2008

Robotics Computer Surgery

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Section: Discussionmentioning

confidence: 99%

“…The questionnaire contained the German version of the assessment form evaluating the Gastrointestinal Quality of Life Index (GIQLI) (12) and the German version of the Reflux Activity Index (RAI) to describe and compare postoperative reflux control (13).…”

Section: Assessment Of Symptoms and Outcomesmentioning

confidence: 99%

Long‐term results of quality of life after standard laparoscopic vs. robot‐assisted laparoscopic fundoplications for gastro‐oesophageal reflux disease. A comparative clinical trial

Hartmann

Menenakos

Ordemann

et al. 2008

Robotics Computer Surgery

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show abstract

“…Several studies used QoL assessments and, as symptoms are one of the four components of health-related QoL, QoL instruments were considered if they had been used in patient populations with gastrointestinal disease. A summary of the content and psychometric properties demonstrated for all identified questionnaires and scales to date is shown in table 2[23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65]. …”

Section: Review Of the Literature: Methods And Resultsmentioning

confidence: 99%

“…GRACI was developed by Williford et al and is a GERD-specific evaluative symptom scale administered at baseline and every 3 months thereafter [37]. It consists of 12 items that are assessed by the study nurse (interview) and five items that are assessed in a patient diary filled out daily for 1 week.…”

Section: Review Of the Literature: Methods And Resultsmentioning

confidence: 99%

Systematic Review: Do We Need a New Gastro-Oesophageal Reflux Disease Questionnaire?

et al. 2007

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Background: Gastro-oesophageal reflux disease (GERD) is highly prevalent in Western countries. Because the majority of patients do not present with endoscopic abnormalities, the assessment of the symptom severity and quality of life, and their response to treatment, has become increasingly important. Self-assessed symptom questionnaires are now key instruments in clinical trials. Aim: To evaluate the validity of available GERD measurement tools. Methods: An ideal GERD symptom assessment instrument, suitable as a primary end-point for clinical trials, should possess the following characteristics: (i) be sensitive in patients with GERD; (ii) cover the frequency and intensity of typical and atypical GERD symptoms; (iii) be multidimensional (cover all symptom dimensions); (iv) have proven psychometric properties (validity, reliability and responsiveness); (v) be practical and economical; (vi) be self-assessed; (vii) use ‘word pictures’ which are easy to understand for patients; (viii) respond rapidly to changes (responsiveness over short time intervals); (ix) be used daily to assess changes during and after therapy; and (x) be valid in different languages for international use. Results: A literature review revealed five scales that met some of the above characteristics, but did not fulfil all criteria. Conclusion: There is a need for a new evaluative tool for the assessment of GERD symptoms and their response to therapy.

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“…This latter instrument was chosen because of its previous validation in patients with GERD in a VA setting. 20 Baseline demographic information was also obtained including age, gender, dominant or most bothersome symptom (heartburn, acid regurgitation, or dyspepsia), duration of PPI therapy, previous GERD treatment, comorbid medical conditions, concurrent medication use, height, and weight.…”

Section: Methodsmentioning

confidence: 99%

Step-Down Management Of Gastroesophageal Reflux Disease

&NA;

2001

European Journal of Gastroenterology & Hepatology

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Background & Aims:As the economic burden of gastroesophageal reflux disease (GERD) is largely weighted to maintenance as opposed to initial therapy, switching from more potent to less expensive medication once symptoms are alleviated (step-down therapy) may prove to be most cost-effective. This study aimed to prospectively evaluate the feasibility of step-down therapy in a cohort of patients with symptoms of uncomplicated GERD. Methods: Patients whose GERD symptoms were alleviated by proton pump inhibitors (PPIs) were recruited from outpatient general medicine clinics. After baseline demographic and quality of life information were obtained, PPIs were withdrawn from subjects in a stepwise fashion. Primary outcome was recurrence of symptoms during follow-up that required reinstitution of PPIs. Secondary outcomes included changes in quality of life and overall cost of management. Predictors of nonresponse to step-down were assessed. Results: Seventy-one of 73 enrolled subjects completed the study. Forty-one of 71 (58%) were asymptomatic off PPI therapy after 1 year of follow-up. Twenty-four of 71 (34%) required histamine 2-receptor antagonists, 5/71 (7%) prokinetic agents, 1/71 (1%) both, and 11/71 (15%) remained asymptomatic without medication. Quality of life did not significantly change, whereas management costs decreased by 37%. Multivariable analysis revealed younger age and a dominant symptom of heartburn to predict PPI requirement. Conclusions:Step-down therapy is successful in the majority of patients and can decrease costs without adversely affecting quality of life.

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Development for and results of the use of a gastroesophageal reflux disease activity index as an outcome variable in a clinical trial

Cited by 41 publications

References 16 publications

Long‐term results of quality of life after standard laparoscopic vs. robot‐assisted laparoscopic fundoplications for gastro‐oesophageal reflux disease. A comparative clinical trial

Long‐term results of quality of life after standard laparoscopic vs. robot‐assisted laparoscopic fundoplications for gastro‐oesophageal reflux disease. A comparative clinical trial

Systematic Review: Do We Need a New Gastro-Oesophageal Reflux Disease Questionnaire?

Step-Down Management Of Gastroesophageal Reflux Disease

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