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Conclusion
The GerdQ is a potentially useful tool for family practitioners and other
health care professionals in diagnosing and managing GERD without
initial specialist referral or endoscopy.
short as possible without compromising sensitivity and four, i.e. the number of response options used in the
specificity. GIS. When the RDQ scale was recoded in this way, it
The diagnosis of GERD, based on the combined use was found that the ROC curve with the recoded scale
of the four objective tests used in the DIAMOND study, was not impaired compared with the original. The
is currently considered the best that can be achieved recoded 4 graded scale (No symptoms, 1 day, 23 days
using objective criteria. This diagnosis was used as the and 47 days of symptoms) was derived from the ori-
reference against which to evaluate firstly the RDQ ginal RDQ scale and also guided by the Montreal defi-
and now the GerdQ. nition of GERD,12 where two or more days of reflux
The analyses of the DIAMOND study data showed symptoms were considered troublesome by the patient
that adding the frequency and severity scores of the and thus indicative of GERD. Moreover, two or more
RDQ items A burning feeling behind your breastbone, days with heartburn (during treatment) is considered
A pain in the centre of the upper stomach (with insufficient control of this symptom.13 The patient
reversed scoring) and Unpleasant movement of mate- input also indicated a preference for a 4-graded scale.
rial upwards from the stomach, provided a useful tool Therefore, for consistency and simplicity, all GerdQ
for diagnosing GERD. This combination was developed items use a four-graded scale, the latter previously
on the basis of RDQ data from another study10 with a validated by Junghard and Wiklund.14 A 1-week recall
population similar to the DIAMOND population and period was chosen on the basis of previous survey
was pre-specified in the DIAMOND study protocol. data and the opinions of patients in the focus groups,
ROC analyses indicated that consultation with a family both in this study and in the process of developing the
physician was comparable to the RDQ in terms of sen- RDQ.15
sitivity and specificity for the diagnosis of GERD, at a
level of approximately 60%.11 The corresponding
Response option selection. The third step was to find
accuracy for the gastroenterologist11 and the GerdQ is
out which, if any, items from GIS and or GSRS would
higher, at approximately 70%.
improve diagnostic accuracy when added to the
selected and recoded RDQ items. For this evaluation, a
Construct criteria for the GerdQ logistic regression with a stepwise selection procedure
was used, where the three most discriminant RDQ
Selection of wording for response options. For the
items, A burning feeling behind your breastbone
development of a simplified questionnaire, GerdQ, it
(positive predictor for GERD), A pain in the centre of
was necessary to investigate first whether both fre-
the upper stomach (negative predictor for GERD) and
quency and severity gradings should be used in the
Unpleasant movement of material upwards from the
response options as in the RDQ. One argument for
stomach (positive predictor for GERD), were forced
symptom frequency scoring is that it is preferred by
into the model with all GIS and GSRS items as factors.
patients over symptom severity scoring, as it is easier
The items that had a significant impact on the accu-
to recall (focus group feedback). It was also found that
racy of diagnosing GERD (ordered from most to least
using frequency alone gave a slightly better ROC curve
significant impact) were the nausea item from GSRS
than severity alone and that the ROC curve based on
(negative impact), the eat drink item from GIS (nega-
frequency alone (sensitivity and specificity for an opti-
tive), the sensation of not completely emptying the
mal diagnosis cut-off 64% and 67%) was as good as
bowels item from GSRS (negative), the urgent need to
the original ROC curve (corresponding sensitivity and
have a bowel movement item from GSRS (positive),
specificity being 62% and 67%), which was based on
the sleep disturbance due to reflux symptoms item
both severity and frequency. Thus, only frequency
and the additional medication (e.g. OTC) item, both
scoring was included in the GerdQ, reducing the num-
from GIS (positive). The nausea item, the sleep item
ber of items by half compared with the RDQ.
and the additional medication items were considered
the most intuitive logical items to include in GerdQ in
Number of response options. The second question addition to the RDQ items above. The GIS and GSRS
was whether it was possible to simplify the question- items were also re-coded and graded by frequency.
naire by reducing the number of response options for The GSRS grades Minor discomfort and Mild discom-
each symptom from six in the RDQ questionnaire to fort were collapsed and considered to represent
Table 1. The GerdQ questionnaire respondents enter the frequency scores after reflecting on their symptoms over the previ-
ous week
1. How often did you have a burning feeling behind your breastbone (heartburn)? 0 1 2 3
2. How often did you have stomach contents (liquid or food) moving upwards to your 0 1 2 3
throat or mouth (regurgitation)?
3. How often did you have a pain in the centre of the upper stomach? 3 2 1 0
4. How often did you have nausea? 3 2 1 0
5. How often did you have difficulty getting a good nights sleep because of your 0 1 2 3
heartburn and or regurgitation?
6. How often did you take additional medication for your heartburn and or 0 1 2 3
regurgitation, other than what the physician told you to take? (such as Tums,
Rolaids, Maalox?)
took part in the DIAMOND study. The diagonal line for GERD. GerdQ reaches a diagnostic accuracy similar
represents the outcome by chance and the GerdQ point to that of the gastroenterologist.
(sum score) closest to the gastroenterologists diagnosis In Figure 2, the GerdQ score is plotted against the
represents a cut-off of 8 (those with a score of 8 or percentage of patients with GERD, reflux oesophagitis
more have a high likelihood of having GERD and and abnormal oesophageal pH, diagnosed according to
those with less than 8 have low or no likelihood). The the DIAMOND study criteria. All of these criteria show
cut-offs 6, 7 and 8 have the highest chance-corrected similar direct correlation with increasing GerdQ cut-
efficiency (efficiency is the probability of correctly off scores. In patients with a GerdQ sum score of 8 or
classifying patients). Of those cut-offs, 8 has the high- more, approximately 80% have GERD and in those
est specificity (71.4%) and sensitivity (64.6%) and con- with a sum score of 37, 50% have GERD. None with
sequently, it is proposed as the cut-off when testing a score of 02 had GERD. The patients in whom the
diagnosis of GERD was made exclusively on the basis
of a positive SAP (n = 15) are distributed across all
GerdQ and RDQ (prespecified comb #1) scores the groups, so that their numbers within each group
100 are too small to be analysed separately. There was also
90
80
GerdQ cut-offs
70 100
Sensitivity (%)
60 90
80 Esophagitis
50 GerdQ Cut-offs 70
Abn pH
60
40 RDQ cut-offs GERD
50
%
30 40
Family Practitioner 30
20 Gastroenterologist 20
10
10 0
02 37 810 1118
0
0 10 20 30 40 50 60 70 80 90 100 n= 10 135 97 61
Specificity (%)
Figure 2. Proportions (%) of patients with reflux oesoph-
Figure 1. ROC curve for GerdQ. Specificity and sensitivity agitis, abnormal oesophageal pH or GERD in each cut-off
by cut-off score. range for GerdQ.
50
None RDQ GERD dim 294 1.17 1.12
40
GerdQ items: heartburn, 294 1.35 1.17
30
20
regurgitation, epig pain,
10 sleep disturbance
0 RDQ GERD dim 295 1.17 1.12
02 37 810 1118 GerdQ items: heartburn, 295 1.17 1.11
GerdQ score regurgitation, sleep
disturbance, additional
medication
Figure 3. Distribution of patients by GerdQ score and
RDQ GERD dim 295 1.17 1.12
baseline heartburn severity (as assessed by the subject
GerdQ items: heartburn, 295 1.16 1.10
together with the investigator).
regurgitation, sleep
disturbance
RDQ GERD dim 303 1.16 1.12
a good direct correlation between heartburn severity at GerdQ items: heartburn, 303 1.10 1.02
baseline and the frequency-based GerdQ score regurgitation, sleep
disturbance
(Figure 3).
Sum of Sleep and OTC scores patients have been diagnosed with GERD, to facilitate
100 patient-physician dialogue, but it is not a diagnostic
90
tool in itself.5 Other instruments such as the PAGI-S22
80 >3
70 3 and ReQuest23 do not meet these criteria. A Chinese
60 2 language GERDQ was developed for use in epidemio-
1
%
even mild reflux symptoms has an increasingly nega- These attributes make GerdQ a potentially useful
tive impact on patient well-being.27 Weekly GERD tool for family practitioners in the diagnosis and man-
symptoms were associated with lower scores on five agement of GERD, without the need for specialist
dimensions of the SF-36 instrument. Identifying and referral or endoscopy.
treating relatively minor changes in symptom status
can often lead to significant improvements in patients
ACKNOWLEDGEMENTS
health-related quality of life.
Declaration of personal interests: Roger Jones, John
Dent and Nimish Vakil have served as speakers, con-
CONCLUSIONS
sultants and advisory board members for AstraZeneca
The results indicate that the patient-centred GerdQ and have received research funding from AstraZeneca.
questionnaire has three potential uses in clinical prac- O. Junghard, B. Wernersson and T. Lind are currently
tice: employees of AstraZeneca and K. Halling is a previous
(i) GerdQ can be used to diagnose GERD with an employee of AstraZeneca. Declaration of funding
accuracy similar to that of the gastroenterologist. interests: This study was funded by AstraZeneca
(ii) GerdQ can be used to assess the relative impact R&D, Molndal. The writing and preparation of this
of the disease on patients lives and to assist in choice paper were funded in part by AstraZeneca R&D,
of treatment. Molndal, Sweden. Writing support was provided by Dr
(iii) GerdQ can be used to measure response to treat- Madeline Frame of AstraZeneca R&D and funded by
ment over time. AstraZeneca.
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