Does The Doctor Assess Your Heartburn Correctly?

Main Category: Acid Reflux / GERD
Also Included In: Clinical Trials / Drug Trials
Article Date: 11 Jan 2008 - 2:00 PST

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A simple scale (None, Mild, Moderate, Severe) is frequently used to grade heartburn severity in clinical trials as well as in clinical practice and the question is whether this scale captures the heartburn severity well enough.

In a recent study, "Validation of a 4-Graded Scale for Severity of Heartburn In Patients with Symptoms of Gastroesophageal Reflux Disease", published in Value in Health, the scale was examined to see whether it stands up to established criteria for a functional scale. The study was co-authored by Ola Junghard and Ingela Wiklund (now GSK, UK) of AstaZeneca R&D, Mölndal.

The examination indicates that in terms of the criteria validity, reliability and responsiveness, the scale works well, both when used by the doctor to assess heartburn severity retrospectively, and when used by the patient to record the severity in daily diary cards. The study is based on data from clinical trials in patients with heartburn but without esophagitis.

It is estimated that at least 10% of Western population have symptoms of gastroesophageal reflux disease (Dent et al, GUT 2005;54(5)).

Dr. Junghard comments "Although this scale has been used in clinical trials in gastroesophageal reflux disease for more than 10 years, it has not been validated before. In light of the increasing focus on patient reported outcomes, the evaluation of patient diary card data is of particular interest."

Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based. The journal is published bi-monthly and has a regular readership of over 3,000 clinicians, decision-makers, and researchers worldwide.

ISPOR is a nonprofit, international organization that strives to translate pharmacoeconomics and outcomes research into practice to ensure that society allocates scarce health care resources wisely, fairly, and efficiently.

Value in Health Volume 11 Issue 6
ABSTRACT

http://www.ispor.org

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