Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2007 Jun 11:5:32.
doi: 10.1186/1477-7525-5-32.

Responsiveness of measures of heartburn improvement in non-erosive reflux disease

Ola Junghard  1 , Katarina Halling
Affiliations

Responsiveness of measures of heartburn improvement in non-erosive reflux disease

Ola Junghard et al. Health Qual Life Outcomes. .

Abstract

Background: When measuring treatment effect on symptoms, the treatment success variable should be as responsive as possible. The aim of the study was to investigate the responsiveness of various treatment success variables in patients with symptoms of heartburn.

Methods: A total of 1640 patients with non-erosive reflux disease (NERD) were treated with proton pump inhibitors for 4 weeks. Treatment success variables were based on a symptom questionnaire (Gastrointestinal Symptom Rating Scale) and on investigator-assessed heartburn, measured at baseline and after 4 weeks of treatment. The rates of treatment success were compared with patients' perceived change in symptoms, assessed by the Overall Treatment Effect questionnaire.

Results: Generally, more stringent treatment success criteria (i.e., those demanding the better response) translated into more responsive treatment success variables. For example, the treatment success variable 'no heartburn' at 4 weeks was more responsive than the variable 'at most mild heartburn' at 4 weeks. Treatment success variables based on change from baseline to 4 weeks were, in general, less responsive than those based on the week 4 assessments only.

Conclusion: In patients with NERD, responsiveness varied among different treatment success definitions, with more demanding definitions (based on the 4-week assessment) giving better responsiveness.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Responsiveness of Gastrointestinal Symptom Rating Scale-assessed heartburn at 4 weeks. Treatment success rate for variables based on the 4-week assessment of the GSRS Heartburn item, by Overall Treatment Effect classification after 4 weeks of treatment; HB, heartburn.
Figure 2
Figure 2
Responsiveness of investigator-assessed heartburn at 4 weeks. Treatment success rate for variables based on the 4-week investigator assessment of heartburn, by Overall Treatment Effect classification after 4 weeks of treatment; HB, heartburn.
Figure 3
Figure 3
Responsiveness of Gastrointestinal Symptom Rating Scale (GSRS)-assessed heartburn, in terms of improvement from baseline to 4 weeks. Treatment success rate for variables based on improvement from baseline to 4 weeks according to the GSRS Heartburn item, by Overall Treatment Effect classification after 4 weeks of treatment.
Figure 4
Figure 4
Responsiveness of investigator-assessed heartburn, in terms of improvement from baseline to 4 weeks. Treatment success rate for variables based on improvement from baseline to 4 weeks, according to investigators' assessment, by Overall Treatment Effect classification after 4 weeks of treatment.
See this image and copyright information in PMC

References

    1. Tytgat GN. Review article: management of mild and severe gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2003;17:52–56. doi: 10.1046/j.1365-2036.17.s2.5.x. - DOI - PubMed
    1. Food and Drug Administration Draft guidance for industry on patient-reported outcomes measures: Use in medicinal product development to support labelling claims. Federal Register. pp. 5862–5863. February 3, 2006.
    1. Revicki DA, Cella D, Hays RD, Sloan JA, Lenderking WR, Aaronson NK. Responsiveness and minimal important differences for patient reported outcomes. Health Qual Life Outcomes. 2006;4:70. doi: 10.1186/1477-7525-4-70. - DOI - PMC - PubMed
    1. Puhan M, Guyatt G, Armstrong D, Wiklund I, Fallone C, Heels-Ansdell D, degl'Innocenti A, Veldhuyzen van Zanten S, Tanser L, Barkun A, Chiba N, Austin P, el-Dika S, Schünemann H. Validation of a symptom diary for patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2006;23:531–541. doi: 10.1111/j.1365-2036.2006.02775.x. - DOI - PubMed
    1. Liu J, Woloshin S, Laycock W, Rothstein R, Finalyson S, Schwartz L. Symptoms and treatment burden of gastroesophageal reflux disease. Arch Intern Med. 2004;164:2058–2064. doi: 10.1001/archinte.164.18.2058. - DOI - PubMed

Publication types