journal of clinical gastroenterology 2007 41 (5) 437-444

Symptom Assessment Tools for Gastroesophageal RefluxDisease (GERD) Treatment

Ronnie Fass, MD, FACP, FACG

Abstract: Relief of symptoms, both typical and atypical, is the

mainstay of therapy for patients with gastroesophageal reflux

disease (GERD); however, evaluation of GERD symptoms’

response to treatment has been hampered by the lack of a

questionnaire that meets all the criteria of an ideal evaluative

GERD symptom assessment tool. These criteria are: sensitivity

in GERD patients, covering all symptom dimensions (multi-

dimensional construct), assessment of frequency and intensity of

‘‘typical’’ and ‘‘atypical’’ GERD symptoms, practical and

economical, easy to understand, responsive over short time

intervals, use as a patient self-assessment tool, amenable to daily

use, psychometrically validated, and translation into many

languages with cross-cultural adaptation. Thus far, 14 instru-

ments have been developed to assess GERD symptoms and

potentially can be used to evaluate treatment response during a

therapeutic trial in GERD patients. However, comparison of the

different evaluative tools is needed.

Key Words: gastroesophageal reflux disease (GERD), heartburn,

quality of life, proton pump inhibitors

(J Clin Gastroenterol 2007;41:437–444)

Gastroesophageal reflux disease (GERD) is a highlyprevalent, chronic condition, with 10% to 30% of

Western populations affected by weekly symptoms.1,2

Studies have demonstrated that GERD and GERDcomplications increase in prevalence in Western andnon-Western populations, suggesting that GERD’s im-pact will further worsen during the third millennium.3–5

GERD has already placed a significant strain onhealthcare resources, as evidenced by a 3-fold increasein ambulatory care visits to primary care physicians andan almost 5-fold increase in visits to specialists for GERDbetween 1990 and 2001.6

There is no clear consensus regarding whichsymptoms constitute a diagnosis or how to defineresponse to the treatment in managing patients withGERD. Furthermore, although many GERD patientsmay manifest with typical symptoms, such as heartburnand acid regurgitation, others may predominantly com-plain of atypical symptoms, such as epigastric pain orpressure, nausea/vomiting, hoarseness, chest pain, andwheezing.7

Symptoms impact health-related quality of life(HRQOL) and treatment satisfaction. HRQOL instru-ments measure the influence of disease on the patient’sphysical, psychologic, and social function, while treat-ment satisfaction instruments assess the extent to whichthe patient is satisfied with the results of treatment.8

Disease-specific HRQOL questionnaires for GERD andother gastrointestinal (GI) disorders [eg, Patient-assessedUpper Gastrointestinal-Quality of Life (PAGI-QOL),9

Quality of Life in Reflux and Dyspepsia (QOLRAD),10

Reflux-Qual Short Form,11 and GERDyzer12] incorpo-rate questions related to general well-being, mood,social activities, eating, drinking, sleep, and work andmany have been found to be reliable, valid, andresponsive. Treatment satisfaction is often assessed as asingle item, although at least 2 validated disease-specifictreatment satisfaction questionnaires are available (ie, theTreatment Satisfaction Questionnaire for GERD,13

GERD Treatment Satisfaction Questionnaire).14 Treat-ment satisfaction may be affected by many variables,including age, sex, vitality, medication, dosing require-ments, and expectations.10 Both HRQOL and treatmentsatisfaction tools aim to provide additional dimensions oftreatment response which may influence a patient’schoice of medication or compliance with therapy, butmay not be captured by assessing only symptomfrequency or severity. However, both improved qualityof life and greater treatment satisfaction correlate withthe reduction in GERD symptom severity and/orfrequency.8,10

Symptom assessment, management, and resolutionremain the primary goals of medical interventions for bothpatients and physicians. Evaluation of the response ofGERD symptoms to treatment, however, has beenhampered by the lack of a valid, reliable, highly responsive,and easy to use assessment tool. The aim of this review isto discuss the features of an ideal symptom assessmentinstrument, and then to examine the strengths andweaknesses of currently available GERD assessment tools.Copyright r 2007 by Lippincott Williams & Wilkins

From the The Neuro-Enteric Clinical Research Group, Section ofGastroenterology, Southern Arizona VA Health Care System andUniversity of Arizona Health Sciences Center, Tucson, AZ.

Supported in part by ALTANA.Reprints: Ronnie Fass, MD, FACP, FACG, The Neuro-Enteric Clinical

Research Group, Southern Arizona VA Health Care System, GISection (1-111G-1), 3601 S. 6th Avenue, Tucson, AZ 85723-0001(e-mail: [email protected]).

CLINICAL REVIEW

J Clin Gastroenterol � Volume 41, Number 5, May/June 2007 437

IDEAL FEATURES OF A GERD SYMPTOMASSESSMENT INSTRUMENT

Development of a GERD symptom assessmentinstrument is hampered by some of the inherent clinicalfeatures of GERD. Thus, an initial issue to be resolved iswhich symptoms should be measured, in light of the widevariety of both ‘‘typical’’ and ‘‘atypical’’ GERD mani-festations. The primary (typical) symptoms of GERD—heartburn and acid regurgitation—are highly specific forGERD (89% and 95%, respectively) but have lowsensitivity (38% and 6%, respectively) for GERDdiagnosis.15 A proportion of patients with GERD eitherdoes not suffer from heartburn at all or more commonlyhas symptoms other than heartburn.16,17 In some cases,underlying symptoms are not apparent until the pre-dominant symptoms are under control. Other difficultiesmay arise when a symptom may be nonspecific, hard tomonitor, or sporadic. Another consideration is whetherthe patient or an outside observer is able to recognize andreport changes in symptoms.

It is not unusual that regulatory agencies requirethat instruments used to assess surrogate markers, such assymptoms or quality of life, will undergo psychometricvalidation when they are designed to be used as primaryoutcome measures in clinical trials. Furthermore, contentvalidity, interrater and intrarater reliability, and respon-siveness for detecting changes in disease severity arepivotal steps in any instrument development.18 Addition-ally, ‘‘if a trial lacks assay sensitivity, it will fail to lead toa conclusion of efficacy.18 In contrast, the trial may findan ineffective treatment to be noninferior and could leadto erroneous conclusion of efficacy.’’

The characteristics of an ideal GERD symptomassessment instrument that would be suitable as aprimary end point for clinical trials are summarized inTable 1.19

GERD SYMPTOM ASSESSMENT TOOLSThis review identified 14 GERD instruments that

are considered to be evaluative (ie, responsive totreatment effects). Brief summaries of these tools arepresented in Table 2.

The GERD ScoreThe GERD Score20 is a 6-item questionnaire that

was developed as an outcome measure of GERD aftermedical and surgical treatment. It is used before and 6months after the treatment, and assesses the severity (on a4-point scale) and frequency (on a 5-point scale) of 6GERD symptoms (heartburn, regurgitation, epigastric orchest pain, epigastric fullness, dysphagia, cough). Thisinstrument has been psychometrically validated andshown to be reproducible, valid [correlated with loweresophageal sphincter pressure, 24-h esophageal pH, and 8subscales of the 36-Item Short-Form General HealthSurvey (SF-36)], and responsive to change (Guyattstatistic=1.0; values >1.00 indicate instruments highlyresponsive to change). A difference of at least 7 scalepoints is thought to indicate a clinically importanttreatment outcome.

The GERD Score does not include atypical orreflux-related symptoms other than the 6 specified above.It is not useful for the assessment of short-term treatmentresponse, and reproducibility over time periods longerthan 6 months has not been determined. Lastly, this scaleis not self-assessed.

Ulcer Esophagitis Subjective Symptoms ScaleThe Ulcer Esophagitis Subjective Symptoms Scale

(UESS)21 uses a Visual Analog Scale (VAS) for theassessment of 10 items covering 4 dimensions (abdominalpain, reflux discomfort=acid regurgitation and heart-burn, intestinal discomfort, and sleep difficulties).Patients are questioned at baseline and again after 4weeks of treatment. The UESS has high internalconsistency for all groups of symptoms (with theexception of intestinal discomfort) and demonstratesconstruct validity and responsiveness for only theintestinal discomfort and reflux discomfort symptomgroups.

The UESS is not specific for GERD and is notsuitable for monitoring symptoms daily because it israther insensitive to change (Guyatt statistic=0.68). TheUESS is available only in Swedish. A Pubmed literaturesearch found no publications since 1993 that used theUESS for GERD.

GERD Symptom Assessment Scale (GSAS)The GSAS is a 15-item patient-assessment tool that

was designed to assess various dimensions of GERDsymptoms (frequency, severity, level of distress) beforeand after treatment.22,23 The GSAS queries patientsabout 15 GI-related symptoms that were reported by atleast 25% of a sample of 169 GERD patients. It includesGI symptoms beyond heartburn that are often excludedby other assessment tools (eg, bloating, nausea, and earlysatiety). Many of these associated symptoms were foundto be as distressful to patients as heartburn.22 Theinstrument is simple to use, practical, relatively short,and easy to understand. The GSAS is valid, stable, andsensitive to changes in severity of symptoms and tochanges over time. Internal consistency was >0.80 for

TABLE 1. The Characteristics of an Ideal Symptom AssessmentInstrument That Could be Used to Monitor Symptom ChangesDuring a GERD Therapeutic Trial

� Sensitive in patients with GERD� Covering frequency and intensity of ‘‘typical’’ and ‘‘atypical’’ GERDsymptoms� Multidimensional (cover all symptom dimensions)� Proven psychometric properties (validity, reliability, sensitivity, andresponsiveness)� Respond rapidly to changes� Able to be used daily� Practical/economical� Patient assessed� Easy to understand� Valid in different languages

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438 r 2007 Lippincott Williams & Wilkins

the symptom severity and distress scales. The GSAS hasproven useful in clinical trials.41,42 Overall, the GSAScannot provide information about daily changes insymptoms during a therapeutic trial.

Gastroesophageal Reflux Disease Activity IndexGastroesophageal Reflux Disease Activity Index

(GRACI) was developed by using multiple regressionanalysis techniques to correlate clinical data with aphysician’s assessment of GERD activity.26,43 Patientshave to fill in a 5-item diary of GERD symptoms everyday for 1 week (frequency of heartburn, percent of daywith heartburn, number of doses of antacids, number ofepisodes of dysphagia, general severity of esophagitis).These items are combined with those obtained by thestudy nurse from patient’s interview during a clinic visit(intake of medication for heartburn other than antacids,esophageal dilatation performed within the past 3months, episodes of: regurgitation, odynophagia, andmorning hoarseness, episodes of: heartburn or regurgita-tion, cough, and/or wheezing that awakened the patientfrom sleep). The derived GRACI score can range from 74(no symptoms) to 172 (worst symptoms). The question-naire is administered at baseline and then at 3-monthintervals. GRACI has proven validity and reliability.26 Ina long-term follow-up study of patients who had beentreated either medically or surgically for GERD, GRACIrevealed differences in GERD burden between the 2treatment groups.44 However, the responsiveness ofGRACI has not been conclusively demonstrated.

The Gastrointestinal Symptom Rating ScaleThe Gastrointestinal Symptom Rating Scale

(GSRS) is often used in clinical trials to evaluate GIsymptoms over time, after treatment, or between patientgroups.23,45,46 Although originally a physician-ratedinstrument,24 in current use the GSRS relies upon patientself-assessment. In the GSRS, 15 items are combined into5 symptom clusters (reflux, abdominal pain, indigestion,diarrhea, constipation), which are quantified according toa 7-point Likert-type scale. It can be completed by mostpatients in about 5 minutes. The GSRS has beentranslated and undergone psychometric evaluation inmany languages, including German, Spanish, Italian,Hungarian, Japanese, Polish, and English.47–52 Psycho-metric evaluation indicated that the 5 scales of the GSRShave good internal consistency (Cronbach a=0.61 to0.83 where values above 0.70 are considered desirable),fair to good test-retest reliability (Cronbach a=0.49 to0.60), and acceptable construct validity. In clinical trials,it has proven responsive to treatment.21,25,53 The GSRSscale has been correlated with the Medical OutcomesStudy Short-Form 36 (SF-36) and the PsychologicalGeneral Wellbeing Scale (PGWB).23

The GSRS was originally developed to measurepeptic ulcer disease and irritable bowel syndrome andthus is not GERD-specific. Psychometric evaluationindicates that the instrument is not very sensitive forGERD.19 Minor differences in psychometric propertieshave been reported among the different language versionsof the GSRS. For instance, test-retest reliability of theabdominal pain domain in the German version was found

TABLE 2. Characteristics of Evaluative Symptom Assessment Tools for GERD

Name Acronym Reference

GERD-

specific

Multi-

dimensional

Self-

assessed

Daily

Assessed

Available in

Different

Languages

Psychometrically

Validated

GERD Score 20 O OUlcer Esophagitis SubjectiveSymptoms Scale

UESS 21 O O (O)*

GERD Symptom Assessment Scale GSAS 22,23 O O O OGastrointestinal Symptom RatingScale

GSRS 23–25 O O O

Gastroesophageal Reflux DiseaseActivity Index

GRACI 26 O O (O)* (O)* O (validity andreliability)

GERD Symptom FrequencyQuestionnaire

GSFQ 27 O O O

Chinese GERD Questionnaire GERDQ 28 O O O OReflux Disease Questionnaire—German version

RDQ 29 O O O O

GERD Assessment Scales 30 O O O OPatient-assessed UpperGastrointestinal Symptom SeverityIndex

PAGI-SYM

31,32 O O O O

Frequency Scale for Symptoms ofGERD

FSSG 33 O O O Japanese (O)*

PPI Acid Suppression Symptom Test PASS-test

34 O O English French O

Reflux Questionnaire ReQuest 35–39 O O O O O OSymptom diary 40 O O

(O)* only parts of the scale.

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r 2007 Lippincott Williams & Wilkins 439

to be only moderate (Cronbach a=0.53).52 Additionally,the Hungarian50 and Polish47 versions found that thetest-retest reliability of the reflux domain is less thanoptimal.

The GERD Symptom Frequency QuestionnaireThe GERD Symptom Frequency Questionnaire

(GSFQ) is short, self-administered, and easy to use.27 Itconsists of 6 questions: 3 items that assess the frequencyof certain GERD symptoms (pain or discomfort in theupper abdomen, pain or discomfort in the area of thebreast bone, rising, spreading, and burning sensationbehind the breastbone) in the previous 7 days, and 3 itemsthat measure effects of GERD symptoms on eating, dailyactivities, and sleep. Each question is scored on a 5-pointscale, so that the sum of all 6 items (maximum is 30)divided by 0.3 is the overall GSFQ score. The GSFQ hasexcellent psychometric properties, including high internalconsistency (Cronbach a=0.84), satisfactory test-retestreliability (intraclass correlation coefficient=0.64), goodvalidity (at least as good as the GSRS), and highresponsiveness, especially to changes in heartburn(Guyatt statistic=1.48).27 Thus far, the instrument hasbeen rarely used in clinical trials.

Chinese GERD QuestionnaireThe GERD Questionnaire’s (GERDQ) main frame-

work is based on the GERQ (gastroesophageal refluxquestionnaire), a validated questionnaire for use inepidemiologic settings.54 The final questionnaire whichis usable in epidemiologic settings and interventionalstudies of GERD in Chinese-speaking patients consists ofthe following 7 items: frequency and severity of heart-burn, frequency and severity of feeling of acidity instomach, frequency and severity of acid regurgitation,and frequency of ‘‘use of antacids.’’28 Both frequency andseverity are assessed on a 5-point Likert scale as none,mild, moderate, severe, incapacitating. Content andconstruct validity have been demonstrated. Furthermore,good reproducibility, test-retest reliability (intraclasscorrelation coefficient=0.75), and internal consistency(Cronbach a=0.90), as well as discriminant validity,have also been shown.

The discriminant validity was proven in a smallgroup of patients receiving proton pump inhibitor (PPI)treatment for GERD (N=35).28 The questionnaire wasdeveloped specifically for Chinese-speaking patients and istherefore not usable in non-Chinese-speaking populations.

Reflux Disease QuestionnaireThe original Reflux Disease Questionnaire (RDQ)

has been used only for diagnostic purposes and consists of12 questions evaluating the frequency and severity ofburning behind the breastbone, pain behind the breast-bone, upper stomach burning, upper stomach pain, acidtaste in the mouth, and movement of material.55

Symptom frequency and intensity are assessed for aperiod of 4 weeks by using 6-point scales ranging from nooccurrence to daily/severe.

In contrast to the original RDQ, a German versionwas created to assess treatment response for a period of1 week. In the process of developing the German version,the original RDQ was translated into German andthen back into English by different translators.29 Becauseof the shorter time frame, the frequency-category ofless than 1 day per week has been eliminated. Byprinciple component analysis, 3 factors (regurgitation,heartburn, and dyspepsia) were identified. Adequatevalidity, reliability, and sensitivity to change have beenshown.

As it is, the questionnaire is not arranged for dailyuse and is currently usable only in German-speakingpatient populations.

GERD Assessment ScalesThe GERD assessment scales were developed by

Liu et al30 and consist of 3 separate scales: (1) a GERDburden scale, (2) a symptoms scale, and (3) a treatmentscale.

The GERD burden scales use a standard ‘‘feelingthermometer’’ ranging from 0 (labeled as ‘‘death’’) to 100(‘‘perfect health’’). The impact of GERD on quality of lifeis measured as the difference between health in the past2 weeks and theoretical health without GERD symptomsand ranges from 0 (GERD has no effect on quality of life)to 100 (GERD has maximum effect).

The symptoms scale consists of 7 common symp-toms plausibly related to GERD (heartburn, regurgita-tion/sour taste, cough, dysphagia/difficulty swallowing,hoarseness/voice changes, belching/bloated feeling, anddiarrhea). The negative impact of these symptoms isassessed for the previous 2 weeks as ‘‘not at all,’’ ‘‘a littlebit,’’ ‘‘a lot,’’ and ‘‘terribly.’’ Additionally, an overallsymptoms assessment (‘‘if you were to spend the rest ofyour life with your reflux symptoms just the way theyhave been during the last 2 weeks, would you feeldelighted, pleased, neutral, unhappy or terrible?’’) isincluded. Scores are generated by summing up thepoints assigned to each response category, from 0(no symptoms) to 3 or 4, depending on the numberof categories. Finally, the scores are transformed to a100-point scale.

The treatment scale consists of 4 domains coveringpatient behaviors to control symptoms (avoiding foods,changing lifestyle, treatments as a problem, and need formedication). For each food avoided, each lifestyle changemade, or each medication used daily 1 point is given. The‘‘treatment as a problem’’ questions are assigned 0 points(not a problem) to 3 points (serious problem). Finally,points are summed and transformed to a 100-point scale.

As far as applicability, the 3 scales have demon-strated content and construct validity as well as goodreliability and responsiveness.

The scales have not been validated separately, andthus the whole questionnaire has to be used. Additionally,the 3 scales are not constructed to be used daily.



Patient-assessed Upper GastrointestinalSymptom Severity Index

The Patient-assessed Upper Gastrointestinal Symp-tom Severity Index (PAGI-SYM) was the product of aninternational collaboration to develop a patient self-assessment instrument for people with GERD, dyspepsia,and gastroparesis.31,32 The final index reflects contribu-tions from 122 patients and 9 gastroenterologists in6 countries, and also information from published literaturesources. At the same time, a companion quality of lifeinstrument was developed (PAGI-QOL). The PAGI-SYM contains 20 items and 6 subscales (heartburn/regurgitation, nausea/vomiting, upper abdominal painand lower abdominal pain, bloating, and fullness/earlysatiety) and is graded on a 6-point Likert scale. The totalPAGI-SYM score is calculated by taking the mean of thesubscales. The PAGI-SYM has been culturally adaptedinto 5 languages. In a study of 1746 subjects (46.4% withGERD, 43.9% with dyspepsia, and 9.7% with gastro-paresis), psychometric evaluation indicated that thePAGI-SYM has good internal consistency (Cronbacha=0.79 to 0.91) and acceptable test-retest reliability over2 weeks (intraclass correlation coefficients a=0.60 to0.82). Construct validity was established with the SF-36Health Survey, the PAGI-QOL, disability days, andglobal symptom severity. GERD subjects seem to havea significantly higher PAGI-SYM scores than dyspepsiasubjects on the heartburn/regurgitation subscale(P<0.0001).31 Both GERD and dyspepsia patients tendto have lower PAGI-SYM scores when their symptomsare relieved by treatment, indicating that PAGI-SYM isresponsive to alterations in clinical status.32

Overall, the PAGI-SYM has not been correlatedwith any objective physiologic tests and is not GERD-specific. In addition, only the severity of each item isassessed and the number of episodes is not considered.

Frequency Scale for Symptoms of GERDThe Frequency Scale for Symptoms of GERD

(FSSG) was developed by asking 124 patients withendoscopically confirmed GERD to answer 50 questionsconcerning the upper GI tract and psychosomaticsymptoms. Twelve questions to which the subjects mostoften answered positively were selected to compose theinstrument.33 Respondents were asked to grade eachquestion on a 5-point scale ranging from 0 (never) to 4(always). At a cut-off score of 8, the FSSG showed asensitivity of 62%, specificity of 59%, and accuracy of60%. Raising the cut-off score to 10 led to 55%sensitivity, 69% specificity, and 63% accuracy. The FSSGscore demonstrated good correlation with endoscopicimprovement. In clinical testing, FSSG scores decreasedafter 8 weeks of treatment with a PPI in some patientswith mild GERD. The effect was less pronounced inpatients with severe GERD symptoms.

The FSSG is an indicator of GERD symptomfrequency, but not symptom severity or level of distress. Itfocuses solely on typical reflux symptoms but does not

address atypical manifestations. The FSSG is currentlyavailable in the Japanese language.

PPI Acid Suppression Symptom TestThe PPI Acid Suppression Symptom Test (PASS-

test) is a simple, 5-item questionnaire designed to identifypatients with persistent acid-related symptoms during PPItherapy and monitor their responses following changes intreatment.34 Subjects are asked whether they are takingprescription medications for stomach pain or discomfort,heartburn, sour taste in the mouth or acid regurgitation,excessive burping or belching, abdominal bloating,nausea, or early satiety. If they answer positively, thenthey are queried if they are still experiencing symptoms, ifthey are taking medications in addition to PPIs for themanagement of these symptoms, if their sleep or eating ordrinking habits are affected, and if the symptoms interferewith daily activities. English and French versions areavailable. Psychometric validation indicates good-to-excellent test-retest reliability (English, 0.76; French,0.68). The PASS-test shows construct validity (moderate-to-high correlation with the GSRS scale), good-to-excellent content validity, and good responsivenessin comparison with other tools including the GSRS. ThePASS-test was able to document the effectiveness ofesomeprazole treatment for patients who had failed priorPPI therapy.34

The PASS-test is not designed to be a comprehen-sive assessment of GERD symptoms. Additionally, thePASS-test does not measure symptom severity orfrequency.

The Reflux QuestionnaireThe Reflux Questionnaire (ReQuest) was developed

to allow physicians to track a range of GERD symptoms,and general well-being, over time.35,36 ReQuest has a longand a short version. Both versions comprise 7 dimensionsthat include general well-being, acid complaints, upperabdominal/stomach complaints, lower abdominal/diges-tive complaints, nausea, sleep disturbances, and othercomplaints. For each dimension, frequency and intensityare determined. (General well-being is an exception, asonly intensity is determined.) The frequency is assessed byusing a 7-point Likert scale, ranging from 0 to >10times/constant and intensity by using a 100-mm VASranging from ‘‘not at all’’ to ‘‘extremely severe.’’ (In thecase of general well-being, the VAS ranges from‘‘wonderful’’ to ‘‘extremely poor.’’) The long versionincludes additional questions related to the occurrence of64 symptoms/complaints (items), which are assigned to6 dimensions (except general well-being).

ReQuest has been divided into 2 subscales:ReQuest-GI includes the dimensions with GI symptoms(acid complaints, upper abdominal/stomach complaints,lower abdominal/digestive complaints, and nausea), andReQuest-WSO assesses aspects of general well-being,sleep disturbance, and other complaints. For interna-tional use, ReQuest is available in 30 different languages.



Psychometric evaluation and validation of ReQuestand its 2 subscales in both patients with erosiveesophagitis37 and nonerosive reflux disease38 have demon-strated a high internal consistency, test-retest reliability,and responsiveness. In clinical trials with ReQuest, timeto first symptom relief, time to sustained symptom relief,and changes in total and individual dimension scores overtime and with treatment are some of the efficacy variablesthat have been measured.39,56,57 ReQuest has also beenused to determine whether healthy people experienceGERD symptoms at a level below a subjective thresholdof impairment.58,59

Recognizing that there is some debate whethertreatment success for GERD reflects endoscopicallyconfirmed healing, symptom relief, or both, investigatorshave combined ReQuest assessments with endoscopicratings to create an integrative index of completeremission (ReQuest/LA-classification). The aim is toallow standardization of clinical assessments and simplifycomparison of the results of different clinical trials.60

Presently, ReQuest is a tool that has been exclu-sively used in clinical research. Additionally, the calcula-tion of sum scores is relatively complex. To be used indaily practice, an adaptation which preserves the psycho-metric properties may be necessary.

Symptom DiaryThe original diary was developed to determine the

severity of dyspeptic symptoms in patients with nonulcerdyspepsia.61 As a result of adaptation, the present diary isintended for daily use in GERD patients.40 It consists of3 questions, the first to be completed in the morning, andthe second and third in the evening. The first questionqueries the presence of any burning feeling during thenight (yes/no), the second records the severity of mostintense burning feeling during daytime (none, mild,moderate, or severe), and the third determines the numberof doses of antacids taken during the last 24 hours.‘‘Burning feeling’’ was used as a word picture forheartburn. The validation study comprised 215 GERDpatients in Canada who were treated with esomeprazole40mg once daily for 4 weeks. For validation purposes, thediary was compared with the QoLRAD questionnaire,4 scales of symptom severity [severity of heartburn, acidreflux, stomach ache, and belching during the last 7 days;rated on a 7-point Likert scale as no problem (1) to verysevere problem (7)], the Feeling Thermometer, andStandard Gamble (SG). For baseline, follow-up andchanges in scores, daytime heartburn proved to have agood correlation with the QoLRAD and the 4 scales ofsymptom severity, whereas the correlation with theStandard Gamble was low. The responsiveness of day-time heartburn was good (standardized responsemean=1.33), and the responsiveness of antacid use wasonly moderate (standardized response mean=0.64).

The diary focuses only on heartburn. There is onlyone definition (or word picture) of heartburn given,namely burning feeling. Additionally, only a very limitedpart of the relevant information concerning heartburn is

being captured. For nighttime heartburn, only thepresence or absence (dichotomous; yes/no) is assessed;for daytime heartburn, only the intensity is assessed.

CONCLUSIONSMany of the 14 scales covered by this review meet

at least some of the parameters of an ideal evaluativeGERD-specific assessment instrument. However, some ofthe scales fail to address the spectrum of GERDsymptoms, and very few can be used daily. Regardless,in the last few years there has been significant progress indeveloping proper tools to assess symptom changesduring therapeutic trials of GERD patients. Presentlythese tools provide better assessment of symptomchanges, although very few are sensitive enough to showdaily alterations in symptom presentation.

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