Measuring symptoms in gastrointestinal cancer: a ... · Results In n=36 validation studies, 26...

ORIGINAL ARTICLE

Measuring symptoms in gastrointestinal cancer: a systematicreview of assessment instruments

Rachelle Pullmer & Wolfgang Linden & Katerina Rnic &

Andrea Vodermaier

Received: 8 September 2013 /Accepted: 9 April 2014 /Published online: 28 May 2014# Springer-Verlag Berlin Heidelberg 2014

AbstractPurpose It is critical for gastrointestinal cancer researchers andclinicians to have access to comprehensive, sensitive andsimple-to-use symptommeasures that allow them to understandand quantify the subjective patient experience. Developmentand validation of such scales requires training in psychometricsand occasionally uses technical jargon that can be difficult topenetrate. This review evaluates existing measures of gastroin-testinal cancer symptoms, provides tool descriptions, and usespredefined, objective quality criteria to rate psychometric qual-ity and facilitate tool choices for researchers and clinicians.Methods MEDLINE, EMBASE, CINAHL, and PsycINFOdatabases were systematically reviewed for scales assessinggastrointestinal cancer and gastrointestinal cancer site-specificsymptoms. Evaluation criteria were the following: breadth ofdomain coverage (content validity), high internal consistency(α≥ .80), sensitivity to change, and extent of validation.Results In n=36 validation studies, 26 gastrointestinal cancersymptom measures were identified. Of these, n=13 tools metcriteria for recommendation, and six in particular showed

strong psychometric properties. The Functional Assessment ofCancer Therapy-Colorectal (FACT-C), European Organizationfor Research and Treatment of Cancer (EORTC) gastric cancermodule (QLQ-STO22), FACT-Hepatobiliary (FACT-Hep), andEORTC oesophagus, oesophago-gastric junction and stomachmodule (QLQ OG-25) were identified as the most comprehen-sive and best validated scales for each of the major gastrointes-tinal cancer sites. The FACT-Colorectal Symptom Index (FCSI-9) and the National Comprehensive Cancer Network(NCCN) FACT-Hepatobiliary Symptom Index (FHSI-18) werespecifically validated in patients with advanced colorectal andliver cancer and also demonstrated superior psychometricproperties.Conclusions Several comprehensive, well-validated scalesexist to adequately assess gastrointestinal cancer site-specificsymptoms. Specifically, gastrointestinal cancer submodules ofthe FACT quality of life questionnaire represent adequate toolchoices in most instances and overall, were better validatedthan the respective EORTC tools. Further improvement ofexisting, highly rated measures is recommended.

Keywords Symptoms . Gastrointestinal neoplasms .

Measures . Psychometrics . Reliability . Validity

Introduction

While incidence of several gastrointestinal (GI) cancers con-tinue to rise, mortality rates are generally declining, leading toan increase in survivors who must cope with symptoms aris-ing from the disease and its treatment [1]. Given the debilitat-ing symptoms associated with GI cancer, assessment andtracking of sequelae are pertinent to patients and care pro-viders. Self-report is typically used to tap into patients’ sub-jective illness experience and symptoms. Patients’ quality oflife (QoL), as well as decisions regarding when to seek

Electronic supplementary material The online version of this article(doi:10.1007/s00520-014-2250-z) contains supplementary material,which is available to authorized users.

R. Pullmer (*) :W. Linden :A. VodermaierDepartment of Psychology, University of British Columbia, 2136West Mall, Vancouver, BC V6T 1Z4, Canadae-mail: [email protected]

W. LindenBC Cancer Agency, Vancouver, BC, Canada

K. RnicDepartment of Psychology, University of Western Ontario, London,Ontario, Canada

A. VodermaierDepartment of Obstetrics and Gynecology—Campus Grosshadern,University of Munich, Munich, Germany

Support Care Cancer (2014) 22:2941–2955DOI 10.1007/s00520-014-2250-z

http://dx.doi.org/10.1007/s00520-014-2250-z

professional help, are primarily driven by presence of suchsymptoms [2, 3].

Generic symptom and QoL measures may be of someuse, but given the diversity of GI cancers and relatedsymptoms, generic measures are considered inferior tothe more sensitive measurement of disease-specificchanges in symptoms [3]. A tool that measures symptomsspecific to a particular cohort of patients can provideessential information regarding patients’ QoL and theefficacy of cancer therapy [3]. Hence, it is critical thatresearchers and clinicians have access to assessment toolsthat (1) measure the symptoms that are specific to each GItumour site and (2) possess sound psychometrics [3].

Over the past two decades, several GI cancer-specificsymptom measures have been developed and validated.Currently, an abundance of QoL and symptom measuresassessing a variety of patient-reported outcomes exist. Thiscan be overwhelming for researchers and clinicians who wishto select an adequate tool with sound psychometric properties,but who are not specifically trained in psychometrics. Alimited set of GI cancer site-specific symptom measures havepreviously been reviewed. Fan and colleagues [4], as well asParameswaran and colleages [5] describe four health-relatedQoL liver and oesophageal cancer measures respectively.However, Fan and colleagues [4] do not provide informationon the psychometric properties of the liver cancer measuresincluded in the review, and neither reviews use explicit criteriato recommend certain tools for clinical use in GI cancerpatients.

To guide researchers and clinicians in their choice of as-sessment tool, we reviewed all obtainable GI cancer site-specific symptom measures, describe their domain coverage(i.e. content validity), and report on their reliability and othertypes of validity. To achieve our goal of providing a relevant,comprehensive, and detailed review, we focus primarily on GIcancers with the highest incidence rates. Measures for thesefour cancers (colorectal, stomach, liver, and oesophageal) aredescribed separately and presented below from highest tolowest according to their incidence rates. Despite high inci-dence rates, pancreatic cancer measures were not comparedhere due to the fact that only two validated symptommeasuresexist.

Methods

Study selection

The data extraction process was performed according to theguidelines for systematic reviews of diagnostic tests in cancer[6]. MEDLINE (1946 to May 2012) and EMBASE (1980 toMay 2012) databases were searched using the OVID inter-face; CINAHL (1982 to May 2012), and PsycINFO (1972 to

May 2012) databases were searched using the EBSCO inter-face for studies conducted with GI cancer patients. A searchtemplate was created inMEDLINE usingMeSH and keywordheadings (see Appendix 1) and adapted for other databases.The Cochrane Library, as well as the Patient-ReportedOutcome and QoL Instruments Database (PROQOLID) weresearched for additional publications. After eliminating dupli-cate studies, the titles, abstracts and full-length articles ofidentified studies were reviewed independently by two au-thors (R.P. and K.R.; Fig. 1). Uncertainty about whether or notstudies met inclusion criteria was resolved by seeking inputfrom another author (W.L.). Additional validation studieswere identified via hand searches of the reference section ofalready identified papers.

Study inclusion and evaluation criteria

Only studies of instruments labeled ‘validation studies’, ad-ministered by an interview or standardized self-report, anddesigned or adapted specifically for GI cancer patients wereincluded. We considered measures in all languages, obtainedfull texts and consulted native speakers when necessary toensure correct classification and interpretation of relevantstudies. We excluded translations of relevant questionnairesinto other languages unless they had been systematically re-validated following translation, as merely translating a mea-sure does not lead to new information about the psychometricproperties of a particular instrument.

Given the considerable complexity and effort required toestablish a tools’ reliability and validity, it is critical thatreviews use a transparent consensus approach in the adoptionof criteria for making value judgements and recommenda-tions. Of particular use for our review was the COSMINconsensus on tool quality for patient-reported outcomes [7,8], which offers a list of tool properties that reviewers shouldextract. The COSMIN checklist is particularly useful for thedevelopment of new tools that use item response theory (IRT).It could therefore only be partially applied for our reviewbecause none of the tools we identified are based on IRT andthe full COSMIN checklist asks for details that are available todevelopers of a new test but are not typically contained inpublished manuscripts.

To maximize the utility of this review, we applied a set ofthree clearly defined criteria to make transparent and replica-ble judgments about the perceived quality of a given scale.Using the COSMIN approach [7, 8], as well as researchconducted by Streiner and Norman as a guide [8], the threecriteria were defined as follows: (1) content validity,operationally defined as relative comprehensiveness ofsymptom coverage (i.e. a full-scale comprehensivenessscore of 4 or above; the detailed rating process isdescribed below), (2) internal consistency (the key index ofreliability, scored as poor if < 0.70; adequate if 0.70–0.79,

2942 Support Care Cancer (2014) 22:2941–2955

and excellent if ≥ 0.80) [9] and (3) extent of validation (ratedon a 1–3 scale, depending on whether one or more samples hadbeen tested and/or whether or not different validation strategieswere used). Two authors (R.P. and K.R.) independently ratedeach scale based on these criteria. Any discrepancies wereresolved by re-consulting the relevant article.

Details for each measure are offered in Tables 1, 2 and 3 [2,10–45], which are organized by GI cancer sub-type. It isimportant to note that these tables list any validation effortsand describe subsequent claimsmade by the authors regardingthe resulting validity of a particular measure. However, due to

the variability in quality of validation work performed, thesuccess of each study in adequately validating a measure isassessed in this review using the aforementioned definedcriteria, which are outlined in Table 4.

Comprehensiveness of symptom coverage

To adequately assess comprehensiveness of symptom cover-age, four studies were identified that collected relevant datafor content validity [2, 10, 16, 28] and that pre-existedresulting publications of the measures themselves. In all of

Fig. 1 Literature review flow chart

Support Care Cancer (2014) 22:2941–2955 2943

Tab

le1

Colorectalcancersymptom

measures

Scale

Num

berof

items-domains

covered

Sample

Internalconsistency

Test–retestreliability

Validity

Adelstein

Symptom

Scale[18]

23-stom

achpain/discomfort;p

ainin

andaround

anus;changein

bowel

habits;b

owelurgency;

incomplete

bowelevacuatio

n;mucus

inbowel

motions;b

lood

from

anus;fatigue;

weightloss;lumpin

stom

achor

anus;low

bloodcount

N=263patientslik

elyto

have

acolonoscopy

Not

reported

Not

reported

Not

reported

Bow

elFu

nctio

nQuestionnaire

[19]

5-bowelincontinence;b

owel

urgency;

bowelfrequency

N=961patientsrecently

undergone

lowanterior

resectionforrectal

cancer

Not

reported

Not

reported*

Incompletelyreported

EORTCColorectalQ

ualityof

Life

Questionnaire

(QLQ-CR29)[20]

29-micturitio

nproblems;abdominal

andpelvicpain;d

efecation

problems;fecalincontinence;

anxiety;

body

image;stom

a-related

problems;sexualitems;singleitems

N=120colorectalcancer

patients

Not

reported

Not

reported

Not

reported

[21]


patients

Range

ofαfrom

0.69

to0.84

forrespectiv

esubscales

ICC=0.68

(7–14days)

Construct

MultitraitScalin

gAnalysis

Developed

from

previously

valid

ated

scale

Criterion

Discrim

inates

know

ngroups;

responsiveness

toclinicalchange

Functio

nalA

ssessm

ento

fCancer

Therapy—ColorectalC

ancer

Subscale(FACT-C)[22]

9-stom

achpain;w

eightloss;bowel

control;digestion;

diarrhea;appetite;

physicalappearance;p

resenceof

ostomy

N=60

colorectalcancer

patients

with

advanced

diseaseN=156

EnglishandSp

anishspeaking

colorectalcancer

patientsfrom

theBilingualIntercultu

ral

OncologyQualityof

Life

project

Range

ofαfrom

0.85

to0.91

forrespectiv

esubscales

Not

reported

Construct

Correlatio

nwith

relevant

constructsof

theFL

IC,B

POMSandPO

MS-SF

Criterion

Discrim

inates

know

ngroups;

responsiveness

toclinicalchange

MSKCCBow

elFu

nctio

nInstrument[23]

18-bowelfunctio

nafter

sphincter-preserving

surgery

N=127patientsundergoing

sphincter-preserving

surgery

Range

ofαfrom

0.75

to0.79

forrespectiv

esubscales

r=0.84

(7–14days)

Construct

Factoranalysis

Correlatio

nwith

relevant

constructsof

the

EORTCQLQ-C30,C

RC38

andFIQ

LCriterion

Discrim

inates

know

ngroups

ModifiedFecalIncontinence

Qualityof

LifeScale[24]

14-lifestyle;coping/behaviour;

depression/self-perceptio

n;em

barassment

N=152patientswho

hadundergone

intersphinctericresectionfor

very

lowrectalcancer

with

transanalcoloanalanastom

osis

α=0.95

Not

reported

Concurrent

Correlatio

nwith

MOSSF

36,H

ADS,and

WCG

NCCNFA

CTColorectal

CancerSym

ptom

Index

(FCSI-9)[10]

9-energy;p

ain;

weightloss;nausea;

diarrhea;swellin

gor

cram

psin

stom

ach;

appetite;ability

toenjoy

life;overallQ

oL

Nopatient

sample

Not

reported

Not

reported

Not

reported


Tab

le1

(contin

ued)

Scale

Num

berof

items-domains

covered

Sample

Internalconsistency


Validity

[25]

N=391metastatic

colorectal

cancer

patients

Range

ofαfrom

0.75

to0.84

forrespectiv

esubscales

ICC=0.76

(4weeks)

Construct

Correlatio

nwith

relevant

constructsof

theEQ-5D

Criterion

Discrim

inates

know

ngroups;

responsiveness

toclinicalchange

NCCNFA

CTColorectalC

ancer

Symptom

Index(N

CCN

FACTFC

SI-19)

[2]

19-Energy;

pain;w

eightloss;nausea;

diarrhea;constipation;

swellin

gor

cram

psin

stom

ach;

numbness/

tingling;

appetite;troublemeetin

gneedsof

family;sleep;w

orry;

hairloss–bother;bowelcontrol;

ability

toenjoylife;overallQ

oL

N=50

colorectalcancer

patients

Not

reported

Not

reported

Not

reported

Patient

Generated

Index(PGI)[26]

5-self-generated

items:assess

quality

oflifeandextent

towhich

theexpectations

ofpatientssufferingfrom

rectal

cancer

arematched

byreality

N=33

rectalcancer

patients

Not

reported

Not

reported

Construct

Correlatio

nwith

relevant

constructsof

theSF

-36,QLQ-C30

andQLQ-CR38

Criterion

Discrim

inates

know

ngroups;

responsiveness

toclinicalchange

Qualityof

LifeInstrumentsfor

CancerPatients:Colorectal

Cancer(Q

LICP-CR)[27]

46-basicphysiologicalfunction;

sexualfunctio

n;independence

functio

n;em

otion;

recognition;

socialsupportand

safety;effect

oflifeandeconom

ics

N=11

colorectalcancer

patient

Range

ofαfrom

0.31

to0.89

forrespectivesubscales

r=0.83

(not

specified)

Concurrent

Correlatio

nwith

Chinese

versionof

FACT-C,FACT-G

andGLICP-GM

aIndexreported

isthewrong

estim

atefortest–retestreliability


Tab

le2

Oesophagealandgastriccancer

measures

Scale

Num

berof

items-domains

covered

Sample

Internalconsistency


Validity

Dysfunctio

nafterUpper

Gastrointestin

alSu

rgery

Scale(D

AUGS20)

[12-14]

20-gastroesophagealreflux;

deglutition

dysfunction;

limited

activ

itydueto

decreasedfood;

diarrhea

symptom

s;dumping

syndromesymptom

s;transfer

dysfunction;

hypoglycem

icsymptom

s

N=662postoperative

gastriccancer

patients

N=221post-operativ

eesophagealcancer

patients

α=0.90

Not

reported

Construct

Factor

analysis

Criterion

Discrim

inates

know

ngroups

EORTCGastricCancer

Module(Q

LQ-STO22)[28]

22-dysphagia;eatingrestriction;

pain;reflux;

anxiety;

single

items

N=114gastriccancer

patients

Not

reported

Not

reported

Not

reported

[39]

N=219gastriccancer

patients

Range

ofαfrom

0.72

to0.80

forrespectiv

esubscales

ICC=0.60

to>0.70

(3–5

days)

Construct

MultitraitScalingAnalysis:

refinedmodule

Correlations

with

QLQ-C30

Criterion

Discrim

inates

know

ngroups;

responsiveness

tochange

EORTCOesophagealCancer

Module(Q

LQ-O

ES1

8)[16-17]

18-dysphagia;deglutition;

eatin

grelateditems;reflux;

pain;anxiety

N=491esophageal

cancer

patients

Not

reported

Not

reported

Construct

Multitraitscalinganalysis:

repeated

item

deletio

nDeveloped

from

EORTC

QLQ-O

ES2

4Correlationanalysiswith

core

questio

nnaire

(QLQ-C30)

Criterion

Discrim

inates

know

ngroups

EORTCOesophagus,

Oesophago-G

astric

Junctio

nandStom

ach

Module(Q

LQ-O

G25)[30]

25-dysphagia;eatingrestrictions;

reflux;o

dynophagia;p

ain;

anxiety

N=300esophageal,gastric,

andesophago-gastric

junctio

ncancer

patients

Range

ofαfrom

0.67

to0.87

forrespectiv

esubscales

Not

reported

Construct

Developed

from

EORTC

QLQ-O

ES1

8andEORTC

QLQ-STO22

Correlationanalysiswith

core

questio

nnaire

(QLQ-C30)

Criterion

Discrim

inates

know

ngroups

EsophagealQ

ualityof

Life

Questionnaire(EQOL)[31]

15-physicalfunctio

n;activ

ities

ofdaily

living;

emotional

functio

n;socialfunctio

n;symptom

s

N=65

oesophagus

and

oesophago-gastric

junctio

ncancer

patients

Not

reported

r=0.73

to0.89

(1week)

Construct

Based

onEORTCQLQ-C30

Concurrent

Correlateswith

MOSSF

-36

Criterion

Responsivenessto

clinical

change


Tab

le2

(contin

ued)

Scale

Num

berof

items-domains

covered

Sample

Internalconsistency


Validity

FACTEsophagealC

ancer

Subscale(FACT-E)[32]

17-eating;

appetite;sw

allowing;

pain;talking/com

municating;

mouth

dryness;breathing

difficulty;coughing;

weightloss

N=83

Oesophagealcancer

patients

α>0.80

Not

reported

Construct

Correlatio

nwith

relevant

EORTCQLQ-30subscales

Criterion

Discrim

inates

know

ngroups;

responsiveness

toclinical

change

FACTGastriccancer

subscale(FACT-Ga)

[33]

19-physical,functional,

emotionaland

social

well-being,andadditio

nal

concerns

(gastric-cancer

specific)

Not

reported

Not

reported

Not

reported

Not

reported

[34]

N=82

gastriccancer

patients

α=0.86

ICC=0.88

(2weeks)

Construct

Correlations

with

anxietyand

depression

measures

Criterion

Discrim

inates

know

ngroups;

responsiveness

toclinical

change

Gastrointestin

alQuality

ofLifeIndex(C-G

IQLI)[35]

17-physicalwell-being;

mental

well-being;

digestion;

defecatio

n

N=140

Postoperativegastric

cancer

patients

α=0.89

ICC=0.88

(2weeks)

Constructa

Factor

analysis

Correlations

with

WHOQOL-BREF-HK

Qualityof

LifeInstrument

forPatientswith

Stom

ach

Cancer(Q

LICP-ST

)[36]

39-disease-specificquality

oflife

N=86

stom

achcancer

patients

α=0.91

r=0.98

(2–3

days)

Construct

Factor

analysis

Item

-owncorrelation

Criterion

Responsivenessto

clinical

change

aAttempted

butp

oorvalid

ationwork


Tab

le3

Liver

cancer

symptom

measures

Scale

Num

berof

items-domains

covered

Sample

Internalconsistency


Validity

EORTCLiver

MetastasesColorectal

Module(Q

LQ-LMC21)[37]

21-eatin

g;pain;fatigue;relationships;

psychosocial;singleitems


patients

with

hepatic

metastases

Not

reported

Not

reported

Not

reported

[38]


patients

with

hepatic

metastases

Range

ofαfrom

0.69

to0.93

forrespectiv

esubscales

Not

reported

Construct

MultitraitScalingAnalysis

Criterion

Discrim

inates

know

ngroups;

responsiveness

toclinicalchange

EORTCHepatocellularCarcinoma

Module(Q

LQ-H

CC18)[39]

18-fatig

ue;b

odyim

age;jaundice;

nutrition;p

ain;

fevers;sexualinterest;

abdominalsw

ellin

gandbody

image

N=158hepatocellu

larcancer

patients

Not

reported

Not

reported

Not

reported

[40]

N=272hepatocellu

larcancer

patients

Range

ofαfrom

0.34

to0.72

forrespectiv

esubscales

ICC=0.64

to0.87

(1week)

Construct

MultitraitScalingAnalysis

Correlatio

nwith

relevant

subscales

ofQLQ-C30

Criterion

a

Discrim

inates

know

ngroups;

responsiveness

toclinicalchange

FACT—Hepatobiliary(FACT-Hep)

[41]

18-abdominaldiscom

fort;w

eightloss;

bowelcontrol;digestion;

diarrhea;

appetite;physicalappearance;b

ack

pain;fatigue;constipation;

daily

activ

ities;jaundice–bother;fevers;

itching;changein

food

taste;

chills;drymouth

N=51

hepatobiliary

cancer

patients

α=0.85

ICC=0.82

(3–7

days)

Construct

Strong

negativ

ecorrelations

with

POMS,

correlationwith

relevant

subscaleof

ISEL,divergedwith

MCSD

SCriterion

Discrim

inates

know

ngroups

[42]

N=158hepatobiliary

cancer

patients

Range

ofαfrom

0.76

to0.97

forrespectiv

esubscales

Not

reported

Criterion

Discrim

inates

know

ngroups;

responsiveness

toclinicalchange

LiverDisease

Qualityof

Life

Questionnaire(LDQOL1.0)

[43]

75-symptom

sof

liver

disease;effects

ofliv

erdisease;concentration;

mem

ory;

quality

ofsocialinteraction;

health

distress;sleep;loneliness;

hopelessness;stig

ma;sexual

functio

ning/problem

s

N=200patientsaw

aitin

gliv

ertransplantation

Range

ofαfrom

0.63

to0.91

forrespectiv

esubscales

Not

reported

Construct

Relevantscalescorrelated

with

PCSandMCSof

SF-36

Criterion

Discrim

inates

know

ngroups

NCCNFA

CTHepatobiliarySy

mptom

Index(N

CCNFA

CTFH

SI-8)

[44]

8-Hepatobiliaryspecificsymptom

sand

issues

(pain;

fatig

ue;n

ausea;

weightloss;jaundice)

N=51

hepatobiliary

cancer

patients

α=0.79

r=0.77–0.86

(3–7

days)

Construct

Significant,negativecorrelations

with

POMS.

Significantpositivecorrelations

with

FACTG,and

FACT-Hep

Criterion

Discrim

inates

know

ngroups

[10]

Nopatient

sample

Not

reported

Not

reported

Not

reported

NCCNFA

CT

HepatobiliaryCancer

Sym

ptom

Index(N

CCNFA

CT

FHSI-18)

[2]

18-energy;p

ain;

weightloss;fatigue;

jaundice– bother;ill

feelings;n

ausea;

abdominaldiscom

fort;m

eetin

gfamilialneeds;appetite;sleepquality

;worry;sadness;treatmentside

effects–bother;abilityto

dousual

activ

ities;o

verallQoL

N=50

hepatobiliary

cancer

patients

Not

reported

Not

reported

Not

reported


these studies, systematic and comprehensive literature reviewswere conducted on symptom prevalence. Further, since rat-ings of symptom severity and prevalence often vary depend-ing on the source, both patients and health care professionalswere consulted [10].

The most important symptoms for each GI cancer subtypewere extracted from these studies, and placed into broadsymptom classes (Table 5). Given that it is important for ameasure to include an adequate amount of broad symptomclasses in addition to more specific items, these two criteriawere rated separately. When rating broad symptom classes, ascore of 3 was given to measures that included ≥ 80% ofclasses, a score of 2 was given to those that included > 50%(but less than 80%), and a score of 1 was given to those thatincluded ≤ 50%. The same criteria were applied when ratingspecific items (i.e. a score of 3 to measures that included ≥ 80%of items, a score of 2 to those that included > 50% and a scoreof 1 to those that included ≤ 50%). After rating eachmeasure onthese two criteria, the two scores were aggregated to create atotal comprehensiveness score ranging from limited (aggregatescore of 3 or less) to extensive (aggregate score of 6) (Table 4).To rate measures that assessed gastric and oesophageal can-cer symptoms simultaneously [15, 30], the relevant broadsymptom classes and specific items for both of these cancerswere amalgamated due to their high overlap.

Reliability

Reliability was defined as internal consistency, and is reported asCronbach’s alpha for the full scale and the subscales (wheneverpossible). Test–retest reliability is also reported to revealwhether a given scale is sensitive to change in longitudinalresearch and clinical trials. Additionally, two searches wereconducted on Health Canada and the US National Institutes ofHealth clinical trial databases to fully consider data on sensi-tivity to clinical change of relevant measures that may havebeen embedded in clinical trials.T

able3

(contin

ued)

Scale

Num

berof

items-domains

covered

Sample

Internalconsistency


Validity

[11]

N=50

hepatobiliary

cancer

patients(stage

IIIandIV

)α=0.89

Not

reported

Concurrent

Correlatio

nwith

FACT-GandFA

CT-Hep

Criterion

Discrim

inates

know

ngroups

Qualityof

LifeforPatientswith

LiverCancer(Q

OL-LC)[45]

22-physicalfunction;

psychological

function;

socialfunction;

symptom

s/side

effects

N=105liv

ercancer

patients

Range

ofσfrom

0.68

to0.81

forrespectiv

esubscales

r=0.71–0.86

(1–2

days)

Construct

Item

swith

ineach

domainconverged

with

oneanother,anddiverged

with

itemsof

otherdomains

Correlatio

nwith

relevant

domains

oftheFL

ICCriterion

Discrim

inates

know

ngroups;

responsiveness

toclinicalchange

aAttempted

butpoorvalidationwork

Table 4 Objectively defined quality criteria

Criteria Labels Definition

Comprehensiveness Limited Total comprehensiveness scoreof 3 or below

Moderate Total comprehensiveness scoreof 4 or 5

Extensive Total comprehensiveness score of 6

Internal consistency Poor α<0.70

Acceptable α between 0.70 and 0.80

High α>0.80

Validity Limited One sample, one type of validity

Moderate One sample, multiple validities

Extensive Multiple samples, multiple validities


Validity

Given the purpose and environment in which symptom mea-sures are typically developed, the assumption was made thatall symptom measures included in this review would haveface validity and at least some content validity. Thus, inaddition to describing domain coverage, we focused on thedescription and evaluation of construct, concurrent, and crite-rion validity for each respective measure.

Results

Thirty-six articles reporting on 26 instruments met inclusioncriteria (Fig. 1). All identified instruments were self-report;none were based on interview. No disagreements on studyinclusion emerged among reviewers. Detailed descriptions ofinstruments and validation information are listed in alphabet-ical order in Tables 1, 2 and 3 [2, 10–45]. Based on criteriamade explicit in Table 4, we decided to recommend thosescales that (1) were rated as at least moderately comprehen-sive, (2) had a mean internal consistency score of ≥ 0.70 and(3) had been rated as at least moderately well validated. As isapparent in Tables 1, 2 and 3, 22 measures were designedspecifically for use in GI cancer patients, whereas 4 [24, 26,35, 43] were originally developed in non-GI cancer popula-tions, but subsequently validated for GI cancer.

It is important to note that all EORTC and FACT question-naires described below are designed to be administered along-side a more generic QoL questionnaire (EORTC QLQ-C30and FACT-G, respectively) [46, 47]. Therefore, the compre-hensiveness of EORTC and FACT questionnaires were ratedaccordingly.

The following scales met all criteria for scale recom-mendation: EORTC colorectal module (QLQ-CR29) [20,21], FACT-C [22], FCSI-9 [10, 25], FHSI-8 [2, 44],FHSI-18, [11, 12], FACT-Hep [41, 42], EORTC livermodule (QLQ-LMC21) [37, 38], QoL Instrument forPatients with Liver Cancer (QOL-LC) [45], EORTCQLQ-STO22 [28, 29], FACT-Gastric (FACT-Ga) [33,34], Dysfunction After Upper Gastrointestinal Surgery(DAUGS-20) [15], FACT-esophageal (FACT-E) [32] andthe EORTC QLQ-OG25 [30]. Among these recommendedscales, five stood out as having particularly strong psy-chometric properties, namely, the FACT-C, FCSI-9, FHSI-18, FACT-Hep and the EORTC QLQ-STO22. No furtherdata on sensitivity to change were found through ourliterature search of Health Canada and the US NationalInstitutes of Health clinical trial databases on GI cancerclinical trials.

Below, unique characteristics and applications for someof the scales are described to reveal idiosyncratic strengthsweaknesses that are not contained in a quantitative evalu-ation alone.

Colorectal cancer

Ten symptom measures validated in 13 studies have beencreated for use amongst colorectal cancer patients.

Measures relevant for all colorectal cancer patients

Five measures (Table 1) have been validated in colorectalcancer patients, regardless of disease stage or treatment. The

Table 5 Relevant broad symptom classes and specific symptoms

Colorectalcancer

Livercancer

Oesophagealcancer

Gastriccancer

Bowel-related items

Control of bowels X

Diarrhea X

Pain

Abdominal pain/discomfort X X X

Abdominal swelling/cramps X X X

Back pain X

Pain/discomfort when eating X X

Chest pain X

General pain X X

Eating-/taste-related items

Appetite X X

Blockage when eating X

Troublesome eating X X

Trouble/change in taste X X

Feeling full too quickly X X

Trouble with digestion

Belching X X

Reflux X

Heartburn X

Trouble with acid/bile X X

Fatigue

Lack of energy X X

Feeling fatigued X X X X

Physical appearance

Jaundice X

Deglutition

Being able to swallow saliva X

Choking when swallowing X

Dysphagia

Eating solid foods X X

Eating soft foods X X

Drinking liquids X X

Other symptoms

Itching X

Nausea X X

Weight loss X X X X


EORTC QLQ-CR29 [20, 21] and FACT-C [22] are two of themost widely used symptom measures because of their modu-lar approach.

Although more comprehensive than the revised scale, theoriginal version of the EORTC QLQ-CR29 was not includedin the present review because it is no longer in use [48, 49].The most recent version of the EORTC QLQ-CR29 is avail-able in 16 languages.

The FACT-C was designed for use in clinical trials andclinical practice evaluation and is available in 36 languages.

Adelstein’s symptom scale [18] is a self-administered ques-tionnaire developed to assess the presence, severity and typeof lower bowel symptoms that may be indicative of colorectalcancer. This scale is designed for use in both research andclinical settings.

While the Patient Generated Index (PGI), a generalQoL measure, was not developed specifically for colorec-tal cancer patients, it has been validated in pre-operativepatients with rectal cancer [26]. The PGI is unique in thatit assesses patient symptomatology and QoL in threestages. In the first stage, patients are asked to list up tofive areas of their lives that have been affected by cancer.In the second stage, patients are asked to rate how currenthealth reality meets their expectations. In the third stage,patients assign a total of 14 imaginary points to areas oftheir life they wish they could improve. Due to the self-generated nature of the questionnaire, an objective assess-ment of its comprehensiveness could not be completed.However, comprehensiveness based on the content areasincluded are comparable to those of the FCSI-19 [2].

The Quality of Life Instruments for Cancer Patients-Colorectal Cancer (QLICP-CR) [27] was designed toassess various aspects of QoL related to colorectal can-cer. We were unable to access the full copy of theoriginal Chinese questionnaire, which precluded ade-quate assessment of the scale’s comprehensiveness.However, the journal article was translated by a bilin-gual Chinese individual, who helped extract importantinformation regarding relevant psychometric propertiesof the tool.

Stage and treatment-specific measures

Five measures (Table 1) have been validated in eitherpatients with advanced disease stage or patients receivingsurgery or chemotherapy for colorectal cancer. Both theNCCN FACT FCSI-9 [10, 25] and the NCCN FACTFCSI-19 [2] were designed for advanced stage colorectalpatients receiving chemotherapy. The FCSI-9 is a short,very comprehensive and internally consistent scale. Themore recent version of the FCSI-9, the FCSI-19, is evenmore comprehensive, yet no information on the scale’sinternal consistency and extent of validation is currently

available. In contrast to one translation of the FCSI-19,the FCSI-9 exists in 28 languages.

Three measures have been developed in postoperative pa-tients who have undergone surgery for colorectal cancer(Table 1). Among these, the Memorial Sloan–KetteringCancer Center Bowel Function Instrument (MSKCC-BFI)[23] was designed for use in colorectal cancer patients whounderwent sphincter-preserving surgery. Due, in part, to itsspecific application, this measure is limited with respect tocomprehensiveness.

Similar to the MSKCC-BFI, the Modified FecalIncontinence Quality of Life Scale [24] was developed foruse in postoperative patients who underwent intersphinctericresection.

The Bowel Function Questionnaire [19] was developedto assess bowel dysfunction after surgery for rectal cancer.The scale has several weaknesses including lack of com-prehensiveness, no reported internal consistency and lim-ited validation no reported internal consistency and limit-ed validation efforts.

Gastric cancer

Five symptom measures (Table 2) have been created for useamongst gastric cancer patients.

Measures relevant for all gastric cancer types

Three measures (Table 2) have been created for use. As withcolorectal cancer measures, the EORTCQLQ-STO22 [28, 29]and the FACT-Ga [33, 34] are the most widely used measures.Both the FACT-Ga (available in 28 languages) and theEORTC QLQ-STO22 (available in 38 languages) are com-prehensive measures. While the FACT-Ga has a higher overallinternal consistency and includes questions about functionaland social/family well-being, the EORTC QLQ-STO22 con-tains more specific symptom-related items.

The Quality of Life Instrument-Stomach Cancer (QLICP-ST) [36] was developed to assess aspects of QoL related tostomach cancer. Given that the original Chinese questionnairewas not retrievable, we were unable to assess the scale’scomprehensiveness.

Treatment-specific measures

Two measures (Table 2) were developed for patients receivingparticular treatments for gastric cancer.

The Chinese Gastrointestinal Quality of Life Index (C-GIQLI) [35] is a culturally adapted version of theGastrointestinal Quality of Life Index. The original scalewas developed for use in patients with gastrointestinal prob-lems; however, Yeung and colleagues [35] validated the scalein postoperative gastric cancer patients. While the measure’s


internal consistency is adequate, its extent of validation andcomprehensiveness is limited.

The DAUGS-20 [15] was developed to assess postopera-tive QoL in gastric and oesophageal cancer patients who havepreviously undergone upper GI tract surgery. The older ver-sion of the DAUGS-20 [12–14] was not included here be-cause it is a precursor to the current version and no longer inuse. The DAUGS-20 is a comprehensive measure with highinternal consistency.

Liver cancer

Seven symptom measures (Table 3) have been created for useamongst liver cancer patients. Both the EORTC QLQ-HCC18[39, 40] and FACT-Hep [41, 42] are widely used measures.However, despite its use in research and clinical trials, theEORTC QLQ-HCC18 (available in 23 languages) is not com-prehensive, and no extant data is available on sensitivity tochange.

The FACT-Hep is available in 40 languages. It is morecomprehensive than the EORTC QLQ-HCC18, has ex-cellent internal consistency and has been extensivelyvalidated.

The EORTC QLQ-LMC21 [38] is the only scale specifi-cally developed for patients with liver metastases from colo-rectal cancer and is available in five languages.

Both the NCCN FACT FHSI-8 [2, 45] and FHSI-18[11, 12] evaluate response to chemotherapy for patientswith advanced disease. Despite the limited validationefforts for the FHSI-8, the scale is concise, comprehen-sive and internally consistent. The more recent versionof the FHSI-8 (the FHSI-18) has a higher internalconsistency and underwent careful development. Itemsendorsed at a greater frequency by both experts andpatients were retained to create a very comprehensivesymptom index. Although the FHSI-18 has not beentranslated, the FHSI-8 is available in 31 languages.

The QOL-LC [45] is a Chinese-specific measure that takescultural background into account.

The Liver Disease Quality of Life Questionnaire(LDQOL 1.0) [43] was originally developed for use inpatients with several types of liver disease. Recently, aSpanish version has been validated in patients awaitingliver transplantation. The LDQOL 1.0 has several limi-tations including length (mean completion time of36 min precludes use in many settings), modest validityand poor comprehensiveness.

Oesophageal cancer

Four symptom measures (Table 2) have been developed foruse amongst oesophageal cancer patients.

The EORTC oesophageal module (QLQ-OES18) [16,17] EORTC QLQ-OG25 [30] and FACT-E [32] areall widely used measures. The EORTC QLQ-OES18(available in 23 languages) is very comprehensive, butinternal consistency and validity are insufficient. TheEORTC QLQ-OG25 was developed for use amongst gas-tric, oesophageal and esophago-gastric junction patients,a n d c omb i n e s t h e EORTC QLQ-OES18 an dEORTC QLQ-STO22 [28 , 29 ] . A l t hough t h eEORTC QLQ-OG25 (available in 11 languages) is verysimilar to the EORTC QLQ-OES18, it covers more keycontent than other oesophageal cancer measures [5]. It isinternally consistent, and more extensively validated thanthe EORTC QLQ-OES18.

The FACT-E (available in 16 languages) assesses symp-toms of oesophageal cancer for use in clinical trials andclinical practice. While the FACT-E is slightly less compre-hensive than the EORTC QLQ-OES18, its internal consisten-cy is excellent.

The Esophageal Quality of Life Questionnaire (EQOL)[31] determines QoL associated with curative treatment mo-dalities in oesophageal cancer patients, and is meant to be usedin conjunction with the EORTC QLQ-C30 [46]. Despiteestablished validity of the scale, it is limited with respect tocomprehensiveness, and no data exists on internal consistency.

Other measures

Another six measures validated in six studies [3, 50–54] werenot extensively analyzed because the focus of this review is GIcancer subtypes with high incidence rates. Two of these mea-sures were designed as general GI cancer symptom measures(scale name not specified [3] and the MDAnderson SymptomInventory [51]).

One measure was developed to assess health-relatedQoL amongst patients with cholangiocarcinoma and gall-bladder cancer (EORTC QLQ-BIL21) [53]. Anothermeasure assesses health-related QoL in patients with GIneuroendocrine tumours (EORTC QLQ-GINET21) [52].A further two measures have been validated in pancreaticcancer patients (i.e., the EORTC QLQ-PAN26 and theGIQLI [50, 54]).

Promising tools and further recommendations

This systematic review identified 26 scales that met inclusioncriteria. Thirteen of these scales were considered to havesufficiently good psychometric properties to permit recom-mendation for use, and five stood out as having the strongestpsychometric properties. The respective modules of the FACTand EORTCQoL scales, (i.e., the FACT-C [22], EORTCQLQSTO-22 [28, 29], FACT-Hep [41, 42] and EORTC QLQ OG-


25 [30]), were rated as best for the major GI cancer sitesinvestigated. Furthermore, for symptom assessment with ad-vanced colorectal or liver cancer, the FCSI-9 [10, 25] andFHSI-18 [11, 12] are adequate tool options. All of the recom-mended tools were developed within the last 13 years andseveral represent revisions of earlier versions.

With respect to colorectal cancer measures, it is importantto note that both the PGI [26] and the QLICP-CR [27] wereonly validated in very small samples (n=33 and n=11, re-spectively). Thus, these measures may benefit from furthervalidation in larger samples. With respect to hepatologicalcancer measures, note that despite the modular approachadopted by the EORTC QoL group, the EORTC QLQ-HCC18 [39, 40] should be revised and re-validated. Whilethe C-GIQLI [35] is comprehensive, further validation isrecommended in other populations due to its culturally sensi-tive nature. Similarly, the DAUGS-20 [15], a gastric cancer-specific questionnaire with sound psychometrics, is in need offurther cross-cultural validation, as its use is currently limitedto Japanese patients. In terms of oesophageal cancer measures,our conclusions are not significantly different fromParameswaran and colleagues [5], but additional recommen-dations and more detailed analysis of psychometric propertiesare added to the literature here.

When it comes to clinical practice recommendations, thefocus of this review on symptom measures should not preventresearchers from adding generic measures of QoL, distress,pain, sleep problems, etc., to their study, depending on theresearch and/or clinical question. There is no singular goldstandard with which to rate multidimensional tools; in eachcase, choosing a tool requires checking whether it has beenvalidated for the intended sample and context.

Several weaknesses were apparent across multiple instrumentsincluded in this review. Repeatedly, we observed that new toolswere developed and applied to a clinical study with minimal, ifany, validation work. Some questionnaires contained subscaleswith low internal consistency but no effort was made to improveon these measures with additional test development work. Thiscriticism does not apply to the recommended measures.

Importantly, 10 out of 26measures (Tables 1, 2 and 3) werenot determined as sensitive to clinical change. Thus, an area ofscale improvement represents the analysis of sensitivity tochange with longitudinal data. This criticism applies to threerecommended measures (EORTCQLQOG-25 [30], FHSI-18[11, 12] and FCSI-19 [2]). However, it is likely due to therecency of tool development that no extant data on sensitivityto change is currently available for the FHSI-18 and FCSI-19.

Conclusion

In summary, a considerable number of GI cancer site-specificsymptom measures with good psychometric properties have

been identified, with submodules of the FACT being the besttool choice for most cancer types. Further improvement ofalready existing, promising measures is recommended.

Disclosures and acknowledgments No funding was received for thismanuscript. None of the authors are in any financial or personal conflictof interest regarding this work. We are very grateful for the feedback ofDr. Jessica McAlpine on an earlier draft of this manuscript.

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