Alimentary Pharmacology and Therapeutics
The use of pictograms improves symptom evaluation by
patients with functional dyspepsia
J. Tack, F. Carbone, L. Holvoet, H. Vanheel, T. Vanuytsel & A. Vandenberghe
Translational Research Center for
Gastrointestinal Disorders (TARGID),
University of Leuven, Leuven, Belgium.
Correspondence to:
Prof. J. Tack, Division of
Gastroenterology, Department of
Pathophysiology, University Hospital
Gasthuisberg, Herestraat 49, B-3000
Leuven, Belgium.
E-mail: jan.tack@med.kuleuven.ac.be
Publication data
Submitted 16 March 2014
First decision 25 March 2014
Resubmitted 05 April 2014
Resubmitted 08 June 2014
Accepted 10 June 2014
EV Pub Online 22 July 2014
This article was accepted for publication
after full peer-review.
ª 2014 John Wiley & Sons Ltd
doi:10.1111/apt.12855
SUMMARY
Background
No validated patient-reported outcome (PRO) measure exists for functional dys-
pepsia (FD) assessment. Verbal descriptions of different upper abdominal symp-
toms may be poorly distinguishable to patients.
Aim
To investigate whether understanding of FD symptoms is enhanced by pictograms
symbolising the nature of the symptoms, besides verbal descriptors.
Methods
Consecutive FD patients were randomised to fill out a questionnaire assessing
nineupper gastrointestinal symptoms (post-prandial fullness, early satiation, epigas-
tric pain, epigastric burning, bloating centred in the upper abdomen, nausea, vom-
iting, heartburn, regurgitation) with or without accompanying pictograms.
Symptoms were rated for frequency and severity (0–5), and patients also identified
the most bothersome symptom. Subsequently, in-depth history was taken by an
expert clinician, who filled out the same symptom ratings. Concordance between
patient and clinician ratings was quantified using chi-square and kappa statistics.
Results
Content validity of pictograms was first confirmed by 15 FD patients. Next, 76
patients (52 women, age 42.2  1.9) were randomised to questionnaires with or
without pictograms. The concordance with clinician’s assessment as gold standard
rose from 36 without to 48% for questions with pictograms (P < 0.0001). Consid-
ering the Rome III subdivision, benefit in concordance with pictograms was pres-
ent for post-prandial distress, epigastric pain syndrome and reflux symptoms.
Kappa statistics confirmed these gains (weighted kappa values for concordance of
symptom frequency ratings rose from 0.214 to 0.446 with pictograms), and also
showed better concordance of the most bothersome symptom with pictograms.
Conclusion
Pictograms accompanying verbal descriptors significantly improve concordance of
functional dyspepsia symptom ratings by patients with evaluation by their
physicians.
Aliment Pharmacol Ther 2014; 40: 523–530
523
J. Tack et al.
INTRODUCTION
Functional dyspepsia (FD) is one of the most prevalent
functional gastrointestinal disorders, and is defined by
the Rome III criteria as the presence of epigastric symp-
toms in the absence of any organic or metabolic disease
likely to explain these symptoms.1 According to the
Rome III consensus, early satiation, post-prandial full-
ness, epigastric pain and epigastric burning constitute
the typical FD symptoms, and a subdivision in
post-prandial distress syndrome (PDS, characterised by
post-prandial fullness and satiation) and epigastric pain
syndrome (EPS, characterised by epigastric pain and
burning) is proposed.1 However, other symptoms like
upper abdominal bloating, belching and nausea often
co-exist.1, 2 Diagnostic categorisation of FD, and distin-
guishing it from other upper gastrointestinal disorders,
depends on accurate assessment of the presenting symp-
tom pattern and severity, as revealed by the patient dur-
ing history taking.1, 2 To date, therapeutic options for
FD are limited, and this is probably at least in part
related to the lack of validated tools for the evaluation of
treatment responsiveness in FD patients according to the
Rome III criteria.3 In the absence of a biomarker, evalua-
tion of symptom severity and response to therapy in FD
depends on patient-reported outcomes (PRO) question-
naires, which provide information on specific health con-
cepts directly from the subjects without interpretation of
the patient’s response by a physician or others. The Food
and Drug Administration (FDA) final guidance, released
in December 2009, provides recommendations for the
use of validated instruments to assess treatment out-
comes, and describes the proper development and psy-
chometric validation of PRO questionnaires to be used
in evaluation of new therapeutic agents.4
Verbal symptom descriptors are used in all PRO
instruments for the evaluation of FD symptom pattern
and severity to date 3 and are also the final outcome of
the PRO-development process according to FDA guid-
ance.4 Appropriate understanding of symptom descrip-
tions requires patients to possess adequate levels of
literacy, abstract thinking capacity and comprehension of
nuances. In this context, PRO instruments should
address the risk related to biases due to cultural, educa-
tional, social and linguistic differences. However, in a
field where experts disagree on the nature and definitions
of specific FD symptoms, and with frequent overlapping
conditions, it is likely that verbal descriptors do not
allow all patients to fully grasp the individual and multi-
dimensional nature of FD symptoms.5–8
524
Pictorial representations have been used in health
communication towards patients, and proven to be effec-
tive in improving comprehension and recall of the pro-
vided information.9–13 Pictograms have a great potential
to facilitate communication with FD patients, and to
overcome some of the barriers identified above. In clini-
cal trials evaluating the efficacy of FD therapies, the use
of pictograms might enhance accurate symptom under-
standing and reporting by the patient, potentially
enhancing the sensitivity and accuracy of detecting
changes in symptom pattern and severity. Hence, the
aim of the present study was to evaluate the use of picto-
grams in FD symptom assessment.
METHODS
Design of pictograms
The Rome slide kit which incorporates pictorial repre-
sentations of FD symptoms,8 was used as a conceptual
guide. One of the authors (AV) produced an original
and simple set of drawings representing the epigastric
region and nine FD-related and upper gastrointestinal
symptoms: post-prandial fullness, early satiation, epigas-
tric pain, epigastric burning, bloating centred in the
upper abdomen, nausea, vomiting, regurgitation and
heartburn1, 2, 6, 7 (Figure 1 shows some examples).
Based on feedback of the other authors, a final drawing
set was produced to be used in patient cognitive and
performance evaluation studies.
Patient selection
Consecutive ambulatory patients between 18 and 70 years
with a diagnosis of FD, were eligible for participation in
the study. Patients had to fulfil the Rome III FD criteria,
implicating that they reported bothersome post-prandial
fullness or early satiation occurring after normal-sized
meals or epigastric pain or burning at least several times
per week during the last 6 months, and all had a negative
upper endoscopy (absence of peptic ulcer disease, erosive
duodenitis or gastritis, reflux esophagitis or Barrett’s
oesophagus, or malignancy in the upper gi tract).1 All
patients spoke Flemish Dutch as their mother tongue and
therefore had a similar linguistic-cultural background.
Cognitive evaluation of pictograms
Cognitive interviews were conducted in focus groups of
FD patients by 3 of the investigators (FC, AV, JT). These
were group sessions where patients discussed and sought
common ground on symptom characteristics, their verbal
Aliment Pharmacol Ther 2014; 40: 523-530
ª 2014 John Wiley & Sons Ltd
 Pictograms in functional dyspepsia symptom assessment
(a) (b) (c)
(f) (g) (h)
Figure 1 | Pictograms indicating (a) location of the stomach, (b) post-prandial fullness, (c) early satiation, (d)
epigastric pain, (e) epigastric burning, (f) upper abdominal bloating, (g) nausea, (h) vomiting, (i) heartburn and (j)
regurgitation.
description and especially the representation by a picto-
gram. Patients were shown the individual pictograms on
a screen one by one and were asked to comment on the
clarity, meaning and relevance of the pictogram to their
symptom profile in an interactive group discussion. The
investigators acted mainly as silent observers of this
process.
Evaluation of the use of pictograms to improve
symptom assessment
Consecutive newly diagnosed FD patients were rando-
mised to fill out a questionnaire assessing nine upper
gastrointestinal symptoms (post-prandial fullness, early
satiation, epigastric pain, epigastric burning, bloating
centred in the upper abdomen, nausea, vomiting, heart-
burn, regurgitation). The questionnaire used verbal de-
scriptors of symptoms that were based on the dyspepsia
symptom severity index (DSSI) questionnaire and on the
PAGI-SYM questionnaire.14–16
Patients were randomised to fill out the questionnaire
with or without accompanying explanatory pictograms.
Symptoms were rated for presence (yes or no). The latter
generated a ‘0’ score in the analysis and in the former
case the patient had to score the symptom for frequency
(1–5; 1 = less than once per week; 2 = once per week;
3 = two to three times per week; 4 = four to five times
Aliment Pharmacol Ther 2014; 40: 523-530
ª 2014 John Wiley & Sons Ltd
(d) (e)
(i) (j)
per week; 5 = daily) and severity (1–5; 1 = very mild;
2 = mild – present but not bothersome; 3 = moderate –
bothersome; 4 = severe, interfering with daily activities;
5 = severe, rendering daily activities impossible). Fur-
thermore, patients were also asked to identify the most
bothersome symptom. Subsequently, in-depth history of
the individual patient’s symptom pattern and severity
was taken by an expert clinician (JT), who used this
information to fill out the same symptom ratings and
who was blinded to the questionnaire filled out by the
patient and its results.
Data analysis and statistics
For each pictogram we determined the proportion of
patients in the focus groups who thought a pictogram
was useful and well-understandable.
In the newly diagnosed consecutive patients, the con-
cordance between the clinician’s symptom pattern evalu-
ation and the questionnaire with or without pictograms
was evaluated by studying concordance of ratings. To do
so, both the frequency and the severity rating for a spe-
cific symptom by the patient were compared with those
of the physician. Given that there were little differences
between concordances for frequency and severity, we
pooled the data into a single number: concordance was
expressed as the percentage agreement (identical score
525
J. Tack et al.

between patient and clinician) for both parameters in the this pictogram also received acceptance from all partici-
entire patient group. Concordance of the predominant pants.
symptom was analysed separately, also expressing the
fraction where patient and clinician identified the same Patient groups evaluating questionnaires with or
symptom. Concordances with the clinician, with our without pictograms to improve symptom assessment
without pictograms, were compared by v2 testing. A total of 76 patients (52 women, mean age
In addition, the agreement of the symptom severity 42.2  1.9 years) were randomised to questionnaires
and frequency rating in the questionnaire with or with- with or without pictograms. The characteristics of both
out pictograms and the clinician’s evaluation was groups are summarised in Table 1. No significant differ-
assessed by simple kappa statistics and refined by calcu- ences in demographic characteristics, concomitant use of
lating weighted kappas using linear weighting. Here, fre- proton pump inhibitors (PPIs) and symptom pattern as
quency and severity ratings differed more and were assessed by the clinician/investigator were noted.
presented separately. Kappa statistics for the agreement
on the predominant symptom were done without Impact of pictograms on concordance of symptom
weighting only. assessment ratings. Both questionnaires with or without
Data are presented as mean  S.E.M. The study was pictograms were well understood and completely filled
powered to detect a 20% difference in questionnaire con- out by all the patients. Based on the patients’ evaluation,
cordance with 85% sensitivity at a P < 0.05. those rating texts with pictograms indicated significantly
lower symptom frequencies and severities for epigastric
RESULTS burning, compared to those rating texts alone (Table 2).
No significant differences occurred for severity and fre-
Cognitive evaluations of the pictograms quency ratings of the other symptoms. For several symp-
A total of 15 FD patients (13 women; mean age toms, the severity or frequency ratings by the physician
48  3.2 years) evaluated the pictogram designs in 3
focus sessions of 5 patients each. All patients reported
post-prandial fullness; 12 (80%) reported early satiety Table 1 | Demographic characteristics and symptom
and vomiting, 10 (66%) experienced epigastric pain and pattern, as assessed by the physician, in both groups
bloating centred in the upper abdomen, 9 (60%) experi-
enced regurgitation, 8 (53%) epigastric burning and 7 Text with
Text alone pictograms P-value
(47%) heartburn and vomiting. All patients had negative
endoscopies; muucosal biopsies were taken in all patients Demographics
Female/male 27/11 25/13 NS
and all were Helicobacter pylori negative. The pictograms
Mean age (years) 40.3  2.7 46.6  2.3 NS
depicting post-prandial fullness, early satiation and bloat- PPI intake 7 5 NS
ing centred in the upper abdomen were unanimously Symptom frequency
considered clear and relevant to the symptom pattern. Post-prandial fullness 2.6  0.3 2.7  0.3 NS
Although individual patients had minor suggestions for Early satiation 1.9  0.3 1.9  0.3 NS
Bloating 2.4  0.3 2.5  0.3 NS
changes to the picture (location or extent of the ‘weight’ Heartburn 1.5  0.3 1.6  0.3 NS
or the ‘belt’), no consistent need for adaptation was Epigastric pain 2.7  0.2 2.1  0.3 NS
revealed. The heartburn and regurgitation pictograms Epigastric burning 0.7  0.4 1.4  0.3 NS
received similar positive evaluations by all patients. The Nausea 2.0  0.3 1.6  0.3 NS
Vomiting 0.7  0.3 0.5  0.2 NS
pictograms depicting epigastric pain and burning were
Regurgitation 1.2  0.5 1.2  0.3 NS
also evaluated as clear and understandable, although a Symptom severity
large subset of patients indicated they did not experience Post-prandial fullness 2.2  0.3 2.2  0.2 NS
the latter symptom. The vomiting pictogram was also Early satiation 1.6  0.3 1.5  0.3 NS
considered clear. The nausea pictogram was most inten- Epigastric pain 2.7  0.4 2.2  0.3 NS
Epigastric burning 0.7  0.4 1.2  0.2 NS
sely debated, especially because some of the patients Bloating 2.0  0.3 2.0  0.2 NS
thought nausea meant a generalised sense of malaise and Nausea 2.0  0.3 1.6  0.2 NS
even fatigue. Upon clarification of the meaning of nausea Vomiting 0.7  0.2 0.6  0.2 NS
in the sense of a sick sensation that precedes the need or Heartburn 1.4  0.3 1.5  0.3 NS
Regurgitation 1.0  0.5 1.3  0.2 NS
desire to vomit, consistent with the Rome III consensus,1

526 Aliment Pharmacol Ther 2014; 40: 523-530

ª 2014 John Wiley & Sons Ltd
 Pictograms in functional dyspepsia symptom assessment

benefit in concordance with pictograms was present for

Table 2 | Patient’s rating of symptom frequency and
most individual symptoms, but only reached statistical
severity, in the groups with text alone vs. text with
pictograms significance for frequency and severity of abdominal
bloating (39% vs. 63% and 26% vs. 66%, P < 0.05), and
Text with for the frequency and severity of epigastric burning (26%
Text alone pictograms P-value
vs. 50% and 16% vs. 53%, P < 0.05). The agreement in
Symptom frequency identification of the most bothersome symptom was
Post-prandial fullness 3.6  0.3* 2.8  0.3* NS numerically higher with the pictograms, but this did not
Early satiation 2.3  0.4 1.9  0.3 NS
Bloating 3.0  0.3 2.4  0.3 NS reach statistical significance (concordance 39% vs. 55%,
Heartburn 2.3  0.3* 2.2  0.3 NS NS). Taking into account the Rome III subdivision, ben-
Epigastric pain 2.9  0.3* 2.7  0.2 NS efit from adding pictograms was present for post-pran-
Epigastric burning 2.6  0.3* 1.3  0.3 0.001 dial distress syndrome (PDS) symptoms (concordance
Nausea 2.0  0.3 1.4  0.3* NS
46% vs. 64%, P < 0.001), for epigastric pain syndrome
Vomiting 0.6  0.3 0.6  0.2* NS
Regurgitation 1.7  0.3 0.9  0.2* NS (EPS) symptoms (concordance 26% vs. 38%, P = 0.02)
Symptom severity and for reflux symptoms (38% vs. 49%, P < 0.05). There
Post-prandial fullness 2.7  0.2* 2.2  0.2* NS was no significant benefit for nausea/vomiting symptoms
Early satiation 1.8  0.3 1.1  0.2* NS
(32% vs. 34%, NS) (Figure 2).
Bloating 2.5  0.3 2.3  0.2 NS
Heartburn 2.2  0.3* 1.7  0.2 NS
Epigastric pain 2.7  0.3* 2.2  0.3 NS Impact of pictograms on agreement measured by kappa
Epigastric burning 2.6  0.3* 1.3  0.2 <0.001 statistics. The overall kappa statistics for symptom fre-
Nausea 1.9  0.3 1.3  0.2* NS quency showed a kappa value of 0.140 (95% confidence
Vomiting 0.7  0.3 0.6  0.2* NS
Regurgitation 1.5  0.3* 1.2  0.2* NS
interval (CI) 0.079–0.201), indicating poor agreement
for questionnaires without the pictograms. This
* P < 0.05 compared to physician rating of the symptom (cfr. increased to a kappa value of 0.341 (95% CI 0.275–
Table 1).
0.406) for questionnaires with pictograms, suggesting
fair agreement. The weighted kappa statistics, which
generated scores which differed significantly from the takes into account closely adjacent values through linear
patient ratings (Tables 1 and 2). weighting, showed a kappa value of 0.214, representing
Using the clinician’s assessment as a gold standard, borderline fair agreement for questionnaires without the
the patient’s questionnaire without pictograms had an pictograms, increasing to a kappa value of 0.446 for
overall ‘concordance’ (symptom frequency and severity questionnaires with pictograms, indicating moderate
ratings) of 36% with the clinician’s evaluation. This over- agreement.
all concordance rose to 48% for the questionnaire Fair agreement for questionnaires without the picto-
accompanied by pictograms (P < 0.0001). Numerical grams was shown for symptom severity by a kappa value

70 Questionnaire
**
Concordance with physician assessment (%)

Questionnaire + pictograms
60

** *
50

Figure 2 | Concordance levels 40 *

for upper gastrointestinal
symptom categories between 30
physician ratings and patient
ratings using questionnaires or
20
questionnaires with
pictograms. *P < 0.05 and
10
**P < 0.01 compared to
questionnaires without
pictogram. 0
All symptoms PDS EPS Reflux Nausea Vomiting

Aliment Pharmacol Ther 2014; 40: 523-530 527

ª 2014 John Wiley & Sons Ltd
J. Tack et al.
of 0.222 (95% confidence interval 0.166–0.278), increas-
ing to a kappa value of 0.333 (95% confidence interval
0.265–0.401) for questionnaires with pictograms. The
weighted kappa statistics showed a kappa value of 0.387,
suggesting fair agreement for questionnaires without the
pictograms. Moderate agreement was reached for ques-
tionnaires with pictograms, with which the kappa value
increased to 0.407.
The kappa statistic for concordance on predominant
symptom demonstrated a kappa value of 0.317 (95% CI
0.152–0.481), indicating fair agreement for questionnaires
without the pictograms. This increased to a kappa value
of 0.622 (95% CI 0.468–0.775) for questionnaires with
pictograms, representing good agreement.
DISCUSSION
For the diagnosis and treatment of functional gastroin-
testinal disorders, identification of the symptom pattern
and its severity are of the highest importance. The symp-
tom pattern determines the diagnostic category, and its
severity will determine the extent of diagnostic evalua-
tions and the scope of potential therapeutic measures in
FD and other functional gastrointestinal disorders.1–
8, 14, 17
In treatment trials for these disorders, PRO ques-
tionnaires, designed to evaluate the symptom response in
the patients’ perception, are the preferred instrument for
assessing therapeutic benefit.3, 4 PRO instruments use
verbal descriptors of individual symptoms, and hence
may be prone to suffer from lack of accurate compre-
hension and distinction of descriptors of different types
of symptoms.5 In the setting of clinical trials, this may
affect selection of the eligible population as well as the
efficacy evaluation.
We therefore studied the benefit of adding pictograms
(pictorial representations designed to illustrate the nature
of symptoms) to a symptom questionnaire in FD
patients. Initial drawings based on the Rome slide kit,
and adapted based on clinician’s feedback, were sub-
jected to cognitive evaluation by a group of consecutive
FD patients in three focus groups. The pictograms were
evaluated as clear and understandable, representing the
intended symptom type, although the nausea pictogram
required a verbal clarification of nausea as a queasiness
or sick sensation; a feeling of the need to vomit, consis-
tent with the Rome III consensus.1
Next, we evaluated whether FD patients understood
the nature and meaning of symptoms better if picto-
grams were added to the verbal descriptors in the ques-
tionnaire. In order to do so, the evaluation of symptom
pattern and severity by an experienced clinician, who
528
was blinded to the questionnaire the patient had filled
out and its results, was used as the reference standard.
We first evaluated the overall concordance in specific
ratings of symptom severity and frequency. The concor-
dance with the physician’s rating was 36% for text ques-
tionnaires and rose to 48% for questionnaires with
pictogram. These improvements with pictograms were
confirmed by the kappa statistics, and were also found
for kappa statistics of concordance in identification of
the most bothersome symptom.
Taken together, these findings indicate a substantial
improvement of the understanding symptom pattern
descriptions by patients when the questionnaire was
accompanied by pictograms. As a consequence of a more
correct identification of the symptom by the patients, rat-
ings of frequency and severity are probably more accurate
and closer to the physician’s ratings. The symptom whose
interpretation benefited most from pictograms is epigas-
tric burning. Most likely, this is attributable to a better dis-
tinction of epigastric burning from heartburn when
pictograms accompany verbal symptom descriptors. The
visually very distinct location of both types of burning
sensation (epigastric vs. retrosternal) probably helped
patients to better separate both symptoms, leading to a
significantly lower incidence and severity rating of epigas-
tric burning with pictograms while heartburn ratings were
not significantly altered. Hence, this aspect probably also
underlies the superior concordance for EPS and reflux
symptoms with physician assessment when pictograms
are used. A second aspect is a better distinction of abdom-
inal bloating from post-prandial fullness when pictograms
are used. This underlies improved concordance with phy-
sician assessment for PDS symptoms. Verbal descriptors
of nausea and vomiting symptoms seem to be better
understood, as for this category no significant gain of pic-
tograms could be demonstrated.
The present study showed that the use of pictograms
improves concordance between the clinician’s and the
patient’s evaluation of symptom pattern and severity. The
gain in concordance was statistically significant, but
numerically modest, ranging between 12 and 18% for
diagnostic categories like PDS and EPS. Also the kappa
statistics, while showing improvement with pictograms,
still brought the level of agreement to ‘moderate’ or ‘good’
agreement. The absolute numbers, both without and even
with pictograms, show the divergence between the
patients’ rating of his/her symptom experience in a ques-
tionnaire, and a detailed history taking by a physician with
a vivid interest in this symptom pattern. This divergence is
likely to be also present for other (functional) disorders
Aliment Pharmacol Ther 2014; 40: 523-530
ª 2014 John Wiley & Sons Ltd
 Pictograms in functional dyspepsia symptom assessment

when relying on the patient to interpret and report on
symptom pattern and severity. However, any gain in accu-
racy, improving agreement between clinician and patient,
can be considered beneficial and therefore we feel that the
use of pictograms offers a substantial progress. We were
not able to demonstrate a gain in the assessment of nausea
and vomiting symptoms. However, further large-scale
studies are needed to evaluate whether pictograms for
these entities can be improved or are redundant. The pic-
tograms accompanying verbal descriptors of gastrointesti-
nal symptoms are potentially applicable in clinical
practice, where they may improve communication on dys-
peptic symptoms between patient and physician. The most
obvious application, however, would be in treatment trials
(patient screening, selection and efficacy assessment) for
functional gastrointestinal disorders, and especially FD,
where there is a lack of well-validated endpoints.3 How-
ever, a number of limitations should be considered. First
of all, the sample size of both the cognitive evaluation and
of the cohort for comparison with physician ratings are
relatively small. Second, all patients were tertiary care
patients. It is conceivable that not only symptom fre-
quency and severity are higher in this patient group, but
also that they have been more focussed on the nature and
occurrence of their FD symptoms. Also, a tertiary care
physician dedicated to evaluating patients with functional
gastrointestinal disorders and especially FD symptoms
may have a different history taking approach and routine
to elicit symptom pattern and severity as compared to pri-
mary or secondary care physician. Hence, it is possible
that concordance between patient and physician may be
even lower at less advanced referral levels of care. This
study only established superiority of text with pictograms
vs. text alone for the DSS questionnaire in the linguistic
and cultural setting in which it was performed. It is con-
ceivable that other languages are more suitable for a uni-
form interpretation of symptom pattern and severity by
patients and physicians. Furthermore, the meaning of pic-
tograms may be interpreted differently in a different cul-
tural, social, educational and linguistic setting. Large-scale
application of pictograms, for instance in an international
treatment trial, would probably require prior evaluation of
the pictogram’s content validity in other languages. More-
over, the mechanisms to evaluate the meaning, interpreta-
tion and use of pictograms in a multi-cultural setting still
need to be established, and could well be of similar com-
plexity as the development and application of the current
strictly verbal questionnaires.
In summary, we have developed a pilot set of picto-
grams to accompany verbal descriptors of upper gastro-
intestinal symptoms in the evaluation of FD symptoms,
and have confirmed their content validity. The use of
these pictograms significantly enhanced concordance of
FD symptom ratings by patients in comparison with the
physician’s evaluation, with the most apparent benefit
for PDS, EPS and reflux symptoms. Our data therefore
suggest that pictograms may be a useful adjunctive for
the development of a PRO for FD. Future studies will
need to evaluate reproducibility of this pilot instrument,
further optimisation of the drawings through use in
larger patient groups with different linguistic settings
and, finally, validation in the setting of a therapeu-
tic trial.
AUTHORSHIP
Guarantor of the article: Professor Jan Tack.
Author contributions: Jan Tack: designed the research
study, collected and analysed the data and wrote the
paper. Florencia Carbone, Lieselot Holvoet, Hanne Van-
heel, and Tim Vanuytsel: collected the data. Alain Van-
denberghe: designed the research study, collected and
analysed the data and wrote the paper. All authors
approved the final version of the manuscript.
ACKNOWLEDGEMENTS
Declaration of personal and funding interests: None.

REFERENCES
1. Tack J, Talley NJ, Camilleri M, et al.
Functional gastroduodenal disorders.
Gastroenterology 2006; 130: 1466–79.
2. Tack J, Bisschops R, Sarnelli G.
Pathophysiology and treatment of
functional dyspepsia. Gastroenterology
2004; 127: 1239–55.
3. Ang D, Talley NJ, Simren M, Janssen
P, Boeckxstaens G, Tack J. Review
article: endpoints used in
functional dyspepsia drug therapy
trials. Aliment Pharmacol Ther 2011;
33: 634–49.
4. U.S. Department of Health and Human
Services FDA Center for Drug
Evaluation and Research; U.S.
Department of Health and Human
Services FDA Center for Biologics
Evaluation and Research; U.S.
Department of Health and Human
Services FDA Center for Devices and
Radiological Health. Guidance for
industry: patient-reported outcome
measures: use in medical product
development to support labeling claims.
December 2009. http://www.fda.gov/
downloads/Drugs/Guidances/

Aliment Pharmacol Ther 2014; 40: 523-530 529

ª 2014 John Wiley & Sons Ltd
J. Tack et al.
UCM193282.pdf accessed on January
20th, 2013.
5. Stanghellini V. Review article: pain
versus discomfort - is differentiation
clinically useful? Aliment Pharmacol
Ther 2001; 15: 145–9.
6. Camilleri M, Dubois D, Coulie B, et al.
Prevalence and socioeconomic impact
of upper gastrointestinal disorders
in the United States: results of the
US Upper Gastrointestinal Study.
Clin Gastroenterol Hepatol 2005; 3:
543–52.
7. Piessevaux H, De Winter B, Louis E,
et al. Dyspeptic symptoms in the
general population: a factor and cluster
analysis of symptom groupings.
Neurogastroenterol Motil 2009; 21: 378–
88.
8. Tack J, Talley NJ. Functional dyspepsia
- symptoms, definitions and validity of
the Rome III criteria. Nat Rev
Gastroenterol Hepatol 2013; 10: 134–41.
9. Mansoor LE, Dowse R. Effect of
pictograms on readability of patient
530
information materials. Ann
Pharmacother 2003; 37: 1003–9.
10. Michielutte R, Bahnson J, Dignan MB,
Schroeder EM. The use of illustrations
and narrative text style to improve
readability of a health education
brochure. J Cancer Educ 1992; 7: 251–60.
11. Morrow DG, Hier CM, Menard WE,
Leirer VO. Icons improve older and
younger adults’ comprehension of
medication information. J Gerontol B
Psychol Sci Soc Sci 1998; 53: 240–54.
12. Zeng-Treitler Q, Kim H, Hunter M.
Improving patient comprehension and
recall of discharge instructions by
supplementing free texts with
pictographs. AMIA Annu Symp Proc
2008; 2008: 849–53.
13. Delp C, Jones J. Communicating
information to patients: the use of
cartoon illustrations to improve
comprehension of instructions. Acad
Emerg Med 1996; 3: 264–70.
14. Van Oudenhove L, Vandenberghe J,
Geeraerts B, et al. Determinants of
symptoms in functional dyspepsia:
gastric sensorimotor function,
psychosocial factors or somatisation?
Gut 2008; 57: 1666–73.
15. Tack J, Janssen P, Masaoka T, Farre R,
Van Oudenhove L. Efficacy of
buspirone, a fundus-relaxing drug, in
patients with functional dyspepsia. Clin
Gastroenterol Hepatol 2012; 10: 1239–
45.
16. Rentz AM, Kahrilas P, Stanghellini V,
et al. Development and psychometric
evaluation of the patient assessment of
upper gastrointestinal symptom severity
index (PAGI-SYM) in patients with
upper gastrointestinal disorders. Qual
Life Res 2004; 13: 1737–49.
17. Drossman DA, Chang L, Bellamy N,
et al. Severity in irritable bowel
syndrome: a Rome Foundation
Working Team report. Am J
Gastroenterol 2011; 106: 1749–59.
Aliment Pharmacol Ther 2014; 40: 523-530
ª 2014 John Wiley & Sons Ltd