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Module 14: Clinical & Applied Pharmacology Evidence Guide
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Gillian E. Cassar, DPsych
George J. Youssef, PhD, MPsych
Simon Knowles, PhD
Richard Moulding, PhD, MPsych
David W. Austin, DPsych
Health-Related Quality of Life in Irritable
Bowel Syndrome
A Systematic Review and Meta-analysis
ABSTRACT
Irritable bowel syndrome (IBS) affects up to 20% of the global population and is associated with impaired health-
related quality of life (HRQoL). This systematic review and meta-analysis aimed to investigate differences in HRQoL
of those with IBS compared with healthy controls and to examine whether HRQoL improves following psychologi
cal intervention. Online databases were searched for articles from 2002 to 2017. Studies were screened and data
extracted according to predetermined criteria. A total of 4,154 citations were identified from which 36 were eligible
for inclusion. Eight studies compared HRQoL of those with IBS (n = 822) with that of healthy individuals (n = 3,809).
Those with IBS suffered significant impairment across all HRQoL domains compared with healthy individuals, with
the majority of effects (Cohen's d) being moderate to large. Twenty-eight studies investigated HRQoL in IBS following
psychological intervention (n = 1,308) relative to controls (n = 1,006). All HRQoL domains improved with large ef
fects following treatment; however, maintenance of these effects was inconsistent. Those with IBS experience poorer
HRQoL than the wider community; nevertheless, psychological interventions are associated with improved HRQoL
across all domains. High-quality studies are needed to better inform gastroenterological nurses of which interventions
are most efficacious in alleviating the burden of IBS, and which IBS subpopulations would benefit.
I
rritable bowel syndrome (IBS) is one of the most
& Boyce, 2003), and intervention (Spiegel, 2009).
common types of functional gastrointestinal dis-
Irritable bowel syndrome is typically diagnosed in
orders, more recently referred to as disorders of
early adulthood and is thought to be more prevalent
the gut-brain interaction (Schmulson & Drossman,
among females (14% compared with 8.9% for males;
2017). Irritable bowel syndrome is chronic in nature
Lovell & Ford, 2012).
and associated with abdominal pain and altered bowel
In the absence of an identifiable biological marker
habit (Ford, 2013; Longstreth et al., 2006; Thakur
(Zijdenbos, de Wit, van der Heijden, Rubin, &
et al., 2018). It imposes a substantial economic burden
Quartero, 2009) dysregulation of the gut-brain axis is
on society (Lovell & Ford, 2012) through absenteeism
accepted as a key factor in the development and main
(Maxion-Bergemann, Thielecke, Abel, & Bergemann,
tenance of IBS (Drossman, 2016; Jones, Dilley,
2006), healthcare utilization (Koloski, Talley, Huskic,
Drossman, & Crowell, 2006). Considerable evidence
Received March 9, 2019; accepted December 20, 2019.
About the authors: Gillian E. Cassar, DPsych, School of Psychology,
Deakin University, Geelong, Australia.
George J. Youssef, PhD, MPsych, School of Psychology, Deakin University,
Geelong, Australia; and The Centre for Adolescent Health, Murdoch Children's
Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia.
Simon Knowles, PhD, Faculty Health, Arts, and Design, Department of
Psychology, Swinburne University of Technology, Melbourne, Australia;
Department of Medicine, The University of Melbourne, Melbourne,
Australia; Department of Psychiatry, St Vincent's Hospital, Melbourne,
Australia; and Department of Gastroenterology and Hepatology, The
Royal Melbourne Hospital, Melbourne, Australia.
Richard Moulding, PhD, MPsych, School of Psychology, Deakin
University, Geelong, Australia.
David W. Austin, DPsych, School of Psychology, Deakin University,
Geelong, Australia.
The authors declare no conflicts of interest.
Supplemental digital content is available for this article. Direct URL citation
appears in the printed text and is provided in the HTML and PDF versions
of this article on the journal's website (www.gastroenterologynursing.com).
Correspondence to: Gillian E. Cassar, DPsych, Faculty of Health, School
of Psychology, Deakin University, Melbourne Burwood Campus, Level
5, Bldg BC, 221 Burwood Hwy, Burwood VIC, Australia 3125 (cgilli@
deakin.edu.au).
DOI: 10.1097/SGA.0000000000000530
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Quality of Life in IBS
exists supporting the role of psychological processes
such as stress, visceral sensitivity, and pain catastrophiz
ing in the onset, expression, perpetuation, and severity
of IBS symptomology (Gaynes & Drossman, 1999;
Naliboff, Frese, & Rapgay, 2008; Thakur et al., 2018).
Background
Past research has consistently found IBS to be associat
ed with impaired health-related quality of life (HRQoL;
Ballou & Keefer, 2017; El-Serag, Olden, & Bjorkman,
2002; Hungin, Whorwell, Tack, & Mearin, 2003;
Koloski, Talley, & Boyce, 2000), which incorporates
the individual's lived experience of IBS, as well as func
tional status in physical, emotional, psychological, and
social domains (see Table 1 for explanation of individu
al HRQoL domains; Wong & Drossman, 2010).
Health-related quality of life is an important patient-
reported outcome in chronic disease (Almario & Spiegel,
2018; Lee et al., 2016; Testa & Simonson, 1996) as it
can inform the gastroenterological nurse of the type of
intervention required to address areas of subjective psy
chosocial impairment (Brandt et al., 2009).
Health-related quality of life can be assessed using a
variety of measures (refer to Table 2 for an overview of
measures included in the current review). Global (e.g.,
visual analogue scales utilizing a basic grading system)
and generic (e.g., 36-Item Short Form Health Survey
[SF-36]; Ware Kosinski, & Keller, 1996) assessment
tools may be considered limited in clinical application
and responsiveness to change (El-Serag et al., 2002;
Fitzpatrick et al., 1992). Irritable bowel syndrome-
specific measures (e.g., Irritable Bowel Syndrome
Quality-of-Life Questionnaire [IBS-QoL]; Patrick,
Drossman, Frederick, Dicesare, & Puder, 1998), on the
other hand, have increased sensitivity and provide
insight into components of HRQoL that are most likely
to be affected in IBS cohorts (Bijkerk et al., 2003).
Rather than focusing on physiological factors in an
attempt to alleviate poor HRQoL in those with IBS, it
may be of greater benefit to address symptom-related
emotions, cognitions, coping strategies, and behaviors
(Brandt et al., 2009; Knowles et al., 2016). This has
been predominantly explored through the administra
tion of psychological interventions. To date, the largest
evidence base for psychotherapy for IBS exists for cog
nitive-behavioral therapy (CBT; Ford et al., 2014b;
Thakur et al., 2018). Cognitive-behavioral therapy is
often combined with various other treatment modalities
in an attempt to modify dysfunctional beliefs and
behaviors that can contribute to suffering and impaired
HRQoL in the context of IBS (Zijdenbos et al., 2009).
Research has also examined mindfulness-based stress
reduction (MBSR; Gaylord et al., 2011), hypnotherapy,
and psychodynamic interpersonal therapy (Naliboff
et al., 2008; Webb, Kukuruzovic, Catto Smith, &
VOLUME 43 | NUMBER 3 | MAY/JUNE 2020
Sawyer, 2007). Various therapeutic techniques have also
been explored, including exposure (to IBS symptoms
and related situations; Ljotsson et al., 2013; Ljotsson
et al., 2014), emotional awareness and expression train
ing (Thakur et al., 2017), and acceptance, stemming
from acceptance and commitment therapy (Ferreira,
Eugenicos, Morris, & Gillanders, 2011).
Systematic and meta-analytic reviews have demon
strated the efficacy of these interventions in relieving
IBS symptoms (Altayar, Sharma, Prokop, Sood, &
Murad, 2015; Ford, Forman, Bailey, Axon, &
Moayyedi, 2008; Ford, Lacy, Harris, Quigley, &
Moayyedi, 2018a; Ford et al., 2018b; Ford et al.,
2014b; Lackner, Mesmer, Morley, Dowzer, &
Hamilton, 2004; Laird, Tanner-Smith, Russell, Hollon,
& Walker, 2016; Thakur et al., 2018; Zijdenbos et al.,
2009). Although these results are relevant and mean
ingful, there has been limited focus on HRQoL as a
treatment outcome, as well as inconsistent treatment
effects across the literature, with no distinct psycho
logical intervention identified as superior to others
(Ljotsson et al., 2013; Ljotsson et al., 2014).
Despite the considerable amount of data published
on interventions for IBS, in recent years, synthesis of
research examining the impacts of IBS compared with
healthy individuals has been neglected. El-Serag et al.
(2002) published the most recent review of studies
focusing on HRQoL in IBS. The authors concluded
that HRQoL was poorer among patients with IBS
compared with healthy controls, with differences
depending on level of severity and recruitment setting.
The authors also considered HRQoL following thera
py for IBS (not limited to psychological interventions)
and determined that patients who demonstrate
response to therapy experience corresponding improve
ment in HRQoL (El-Serag et al., 2002).
Several empirical intervention studies using HRQoL
as an outcome measure have been published since this
time. Therefore, a new systematic and meta-analytic
approach to HRQoL in IBS is warranted. An examina
tion of more recent research is necessary to further
understand differences between HRQoL outcomes in
those with IBS compared with the healthy population,
as well as to better inform contemporary psychological
treatment recommendations for individuals with IBS.
Accordingly, this systematic review and meta-analysis
of the literature has two primary objectives: (1) to
compare the domains of HRQoL of individuals with
IBS with those of healthy controls, and (2) to examine
psychotherapy-related change in the domains of
HRQoL of those with IBS.
Methods
This systematic review and meta-analysis is registered
with PROSPERO International Prospective Register of
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Quality of Life in IBS
TABLE 1. Summary of Health-Related Quality of Life Domains
Domain Name
Explanation
Activity interference
+PZY\W[PVUVMKHPS`HJ[P]P[PLZLNJVUJLU[YH[PUNM\SASSPUNYLZWVUZPIPSP[PLZLUNHNPUNPUSLPZ\YL
activities).
Bodily pain
Self-rated level of pain and discomfort, which may interfere with daily functioning.
Body image
Perception of oneself in relation to gastrointestinal symptoms (e.g., feeling fat or limited in
regard to choice of clothing).
Discomfort
*H\ZLKI`NHZ[YVPU[LZ[PUHSZ`TW[VTZHUKOV^IV[OLYZVTLVYPUJVU]LUPLU[[OLZLHYL
WLYJLP]LK[VIL
Dysphoria
0U]VS]LZ[OLTLZVMOLSWSLZZULZZPYYP[HIPSP[`HUKWLYJLP]LKSHJRVMJVU[YVSYLNHYKPUNIV^LS
WYVISLTZ
Emotional functioning Encompasses life satisfaction and the impact of IBS on one's emotions.
Emotional role
limitations
0TWHJ[VMLTV[PVUHSKPMAJ\S[PLZVUKHPS`[HZRZHUKHJ[P]P[PLZLNUV[WLYMVYTPUN^VYR[V[OL
usual standard).
Diet
0U[LYMLYLUJLJH\ZLKI`0):PU[OLMVYTVMH]VPKHUJLVYZLUZP[P]P[`[VWHY[PJ\SHYMVVKJOHUNL[V
amount eaten, or to the appeal of food.
General health
6ULZWLYJLW[PVUHUKL]HS\H[PVUVMOPZVYOLYV]LYHSSOLHS[OLNILSPLMZHIV\[OLHS[OZ[H[\Z
HUKWLYJLP]LKZ[HIPSP[`VYKLJSPULPU^LSSULZZ
Health anxiety
-LHYYLNHYKPUNIV^LSKPMAJ\S[PLZHUKWLYJLP]LK]\SULYHIPSP[`[VV[OLYPSSULZZLZHZHYLZ\S[VM
IBS, or worsening of current symptoms.
Mental composite
Aspects of general mental health, role, and social functioning, emotional status, and vitality.
Mental health
:LUZLVMWZ`JOVSVNPJHS^LSSILPUNVYKPZ[YLZZ9LSH[LZ[VTVVKHUKHMMLJ[HZ^LSSHZ[OL
impact of stress.
Physical composite
+LYP]LKMYVTMHJL[ZVMWO`ZPJHSM\UJ[PVUPUNHUKYVSLHZ^LSSHZIVKPS`WHPUHUKV]LYHSSOLHS[O
perception.
Physical functioning
0TWHJ[HUKPU[LYMLYLUJLVMOLHS[OVUKHPS`WO`ZPJHSHJ[P]P[PLZIV[OTPSKHUKZ[YLU\V\Z"
LN^HSRPUNSPM[PUNVYJSPTIPUNZ[HPYZ
Physical role
limitations
3PTP[H[PVUZPUVULZHIPSP[`[VWLYMVYT\Z\HSWO`ZPJHSHJ[P]P[PLZH[^VYRVYOVTL
(e.g., accomplishing less than desired).
9LSH[PVUZOPWZ
0TWHJ[VM0):VUIV[OJSVZLHUKKPZ[HU[YLSH[PVUZOPWZ
Sexual
Interference with or avoidance of sexual activity as a result of IBS (e.g., reduced satisfaction or
desire).
Social functioning
Impact of IBS on social engagement through emotional or physical limitations that could
impede activities such as visiting friends.
Social reaction
Fear and worry of negative social evaluation related to IBS.
Social role
Avoidance of or interference in social activities, and feelings of discomfort in social contexts.
Vitality
Energy levels and fatigue.
Sleep
0U[LYMLYLUJL^P[OZSLLWLNKPMAJ\S[`MHSSPUNHZSLLW^HRPUNK\YPUN[OLUPNO[VY^HRPUNLHYSPLY
than usual due to IBS).
Total
0TWHPYTLU[PUV]LYHSSM\UJ[PVUPUNLUJVTWHZZPUNHZWLJ[ZVM^VYRZVJPHSLTV[PVUHSHUK
WZ`JOVSVNPJHS^LSSILPUN
Note. IBS =PYYP[HISLIV^LSZ`UKYVTL0UKP]PK\HSKVTHPUZHYLIHZLKVUZ\IZJHSLZVM]HYPV\ZOLHS[OYLSH[LKX\HSP[`VMSPMLTLHZ\YLZ
PUJS\KLKPU[OLJ\YYLU[YL]PL^*OHZZHU`L[HS "+YVZZTHUL[HS"/HOU2PYJOKVLYMLY-\SSLY[VU
4H`LY "/HSKLYL[HS
"4\UK[4HYRZ:OLHY
.YLPZ["7H[YPJRL[HS ":[L^HY[/H`Z
>HYL ">HYL:UV^2VZPUZRP .HUKLR "
>HYLL[HS
Systematic Reviews (crd.york.ac.uk/prospero/index.
Literature Search
asp identifier: CRD42015029687) and was performed
Separate online searches of all articles from 2002 to
in accordance with the Preferred Reporting Items for
2017 were performed by the first author on November
Systematic Reviews and Meta-Analyses (PRISMA)
23, 2017 in MEDLINE, PsycINFO, CINAHL
guidelines (Moher et al., 2015).
Complete, EMBASE, InformIT, and Cochrane Library.
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Quality of Life in IBS
TABLE 2. HRQoL Measures Utilized in Studies Included in the Meta-Analysis
Measure
Summary
Generic measures
0[LT:OVY[-VYT/LHS[O:\Y]L`:- "
>HYLL[HS
0[LT:OVY[-VYT/LHS[O:\Y]L`:-"
>HYLL[HS
Functional Digestive Disorders Quality of Life
8\LZ[PVUUHPYL-++863"*OHZZHU`L[HS
>VYRHUK:VJPHS(KQ\Z[TLU[:JHSL>:(:"
4\UK[L[HS
4LHZ\YLZV]LYHSSOLHS[OZ[H[\ZPUIV[OJSPUPJHSHUKNLULYHSWVW-
ulations, encompassing physical and mental health factors.
0UJS\KLZX\LZ[PVUZMYVT[OL:- YLSH[LK[VWO`ZPJHSOLHS[O
and role limitations, social functioning, role
SPTP[H[PVUZK\L[VLTV[PVUHSKPMAJ\S[PLZWHPUNLULYHSOLHS[O
energy, and mental health.
Assesses physical, psychological, and perpetual impacts of
dyspepsia and IBS.
4LHZ\YLZM\UJ[PVUHSPTWHPYTLU[H[[YPI\[HISL[VHU
PKLU[PAHISLJVUKP[PVUVYWYVISLT
+PZLHZLZWLJPAJTLHZ\YLZ
0YYP[HISL)V^LS:`UKYVTL8\HSP[`VM3PML0UZ[Y\TLU[
0):8V3"7H[YPJRL[HS
0YYP[HISL)V^LS:`UKYVTL8\HSP[`VM3PML
8\LZ[PVUUHPYL0):863"/HOUL[HS
4LHZ\YLZ0):Z`TW[VTMYLX\LUJ`HUKPU[LYMLYLUJL
NLULYHS^LSSILPUNHUKM\UJ[PVUPUNHUKWLYJLW[PVUZYLSH[LK
[V/98V3ZWLJPAJ[V0):
Assesses emotional and mental health, energy, sleep, physical
M\UJ[PVUPUNZL_\HSILOH]PVYZKPL[ZVJPHSHUKWO`ZPJHSYVSLZ
HUKOLHS[OYLSH[LKILSPLMZ
Note./98V3=OLHS[OYLSH[LKX\HSP[`VMSPML"0):=PYYP[HISLIV^LSZ`UKYVTL
Combinations of relevant search terms were used, for
example, irritable bowel syndrome OR (irritable bowel
or irritable colon or mucous colitis or IBS) AND qual
ity of life OR quality of working life, with limits (e.g.,
English language). Supplemental Digital Content 1,
available at: http://links.lww.com/GNJ/A60, can be
accessed for the full search strategy.
A manual search for relevant articles was performed
by the first author using reference lists from previous
reviews. Articles identified as relevant were located and
screened for eligibility. Dual data extraction was per
formed by the second and last authors. The prevalence
and bias-adjusted (PABAK; Byrt, Bishop, & Carlin,
1993) was used to estimate agreement. PABAK was
equivalent to 0.83 indicating strong agreement. Any
uncertainty regarding inclusion or exclusion of studies
was resolved between members of the investigative team.
Study Selection Criteria
Only full-length published manuscripts in English were
eligible for inclusion. The first author reviewed the
titles and abstracts of all the citations identified
through the literature search. The full-length articles
for potentially relevant abstracts were obtained for
further screening to determine eligibility.
The following inclusion criteria were required to be
fulfilled: (1) participants aged 18 years and older to
ensure an adult sample; (2) participants specifically
described as suffering from diagnosed IBS (including
self-report); and (3) HRQoL measured using a vali
dated generic or IBS-specific instrument (not global
assessment alone). For Objective 1, to compare HRQoL
in those with IBS with healthy controls, an additional
selection criterion was (4) a control group that identi
fied as "healthy" (not suffering from other gastrointes
tinal or physical health conditions). For Objective 2, to
assess HRQoL of participants with IBS following psy
chological intervention, study selection was limited to
(5) randomized controlled trials (RCTs), and 6) the use
of psychological treatments (without pharmacological
intervention in adjunct, with the exception of "treat
ment as usual" [TAU]).
For both objectives, studies that recruited participants
with identifiable comorbid physical or gastrointestinal
conditions were excluded on the basis that this could
confound HRQoL outcomes. Studies that identified par
ticipants as having comorbid psychological conditions
(e.g., anxiety or depression) were not excluded, as this is
commonplace in the IBS population, even when not
explicitly assessed (Brandt et al., 2009). Where relevant,
the HRQoL measure that was most similar with other
studies was utilized to ensure consistency in compari
sons. Where data were presented according to consul-
tors (those who tend to have increased severity in IBS
symptoms for which medical attention is often sought;
Drossman et al., 2011) and nonconsultors (people with
IBS who have not consulted a physician; Kanazawa
et al., 2004), data for consultors were utilized to better
align with data extracted from other study samples. For
Objective 2, to examine HRQoL following psychologi
cal intervention, studies in which the only comparison
was another form of psychotherapy were excluded.
Data Extraction
Data were independently extracted by the first and last
authors. Relevant details (e.g., study design, sample
VOLUME 43 | NUMBER 3 | MAY/JUNE 2020
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Quality of Life in IBS
demographics, and intervention framework) were record
ed from each study. Several articles displayed HRQoL
data in visual format only, which was unable to be includ
ed in analysis. In these cases, and those in which results
were unclear, corresponding authors were contacted via
e-mail for clarification. It was then determined whether
the study was able to be utilized on the basis of available
information and the stipulated inclusion criteria.
For studies examining HRQoL in those with IBS
compared with healthy controls, the following charac
teristics were extracted and coded: recruitment setting,
diagnostic criteria and method, and HRQoL measure
(disease specific or generic). For studies investigating
HRQoL following psychotherapy, additional interven
tion characteristics were extracted and coded, includ
ing type, duration, format, clinician, and delivery
mode; session frequency and length; control type
(active or passive); and whether TAU was continued
throughout the trial.
When more than one criterion was utilized to estab
lish IBS diagnosis, it was classified and coded accord
ing to the more frequently used or most recent criteria
to enable comparison with other studies. Similarly, as
most treatments adopted blended approaches, inter
vention type was categorized according to the pre
dominant treatment approach utilized, unless it was
specifically described as multimodal in the trial.
Intervention delivery mode was coded according to the
dominant approach adopted, unless described as hav
ing utilized various modalities.
Risk of Bias
All RCTs were reviewed for risk of bias (ROB) accord
ing to the Cochrane guidelines (Higgins et al., 2011).
The following domains were rated as low, high, or
unclear for ROB: randomization, allocation conceal
ment, blinding of outcome assessment, and selective
reporting. "Low" was elected when the study either
successfully took steps to reduce ROB or attempted to
do so. A rating of "high" ROB was given when the
study failed to address the domain or it was poorly
addressed. "Unclear" was nominated when insufficient
information was provided to determine ROB.
Given the observational nature of the non-RCT
studies, formal ROB assessment was not undertaken.
Risk of bias in these studies was instead addressed
using a components approach based on rating the stud
ies on key methodological factors that may influence
the results, specifically, recruitment setting, diagnostic
criteria and method, and HRQoL measure utilized.
Data Analyses
Meta-analyses were performed using the metafor pack
age v2.0 (Viechtbauer, 2010) in R software v4.2 (R
Core Team, 2017). The main outcome of interest was
HRQoL and, specifically, the distinct domains of
HRQoL. Cohen's d was used as the effect size when
comparing individuals with IBS with healthy controls.
For analyses examining psychotherapy-related change,
we first calculated the standardized mean change over
time (using change score standardization) in each of
the treatment and control groups and then used
Cohen's d as the primary between group effect size. We
used an estimated pre-/postcorrelation of r = .50 for
all analyses. A sensitivity analysis found that using a
more conservative pre-/postcorrelation of r = .30 did
not alter the interpretation of findings (i.e., magnitude
of effects was slightly attenuated; however, the direc
tion and statistical significance of results were consist
ent). As such, all results are based on an estimated pre-/
postcorrelation of r = .50.
Analyses examining psychotherapy-related change
involved assessment at four time points: baseline, postin
tervention, follow-up at 3-6 months (Time 1 assess
ment), and longitudinal follow-up at 6-12 months
(Time 2 assessment). When multiple follow-up time
points were available for a specified assessment time
frame (e.g., follow-up at 3 and 6 months, both of which
fall within Time 1 assessment), we used the longest time
point within the given assessment time frame. A sensitiv
ity analysis was conducted to examine whether results
differed depending on inclusion of the earlier time point.
For studies investigating therapy-related change,
when multiple interventions were examined within the
single study, the same control group data were used as
the comparison group. All analyses used random-effects
models. Heterogeneity was assessed using the I2 statistic
(25% = low, 50% = moderate, 75% = high; Higgins,
Thompson, Deeks, & Altman, 2003). Interpretation of
Cohen's d was based on guidelines stipulated in Cohen
(1992): 0.2 = small, 0.5 = medium, and 0.8 = large.
Meta-regression analyses were conducted to explore
whether effects were robust to methodological differ
ences between studies. For studies investigating HRQoL
in those with IBS compared with healthy controls, the
categorical moderators included recruitment setting,
diagnostic criteria and method, and HRQoL measure.
In addition to the aforementioned moderators, the fol
lowing were examined in studies assessing change in
HRQoL following psychological intervention: treat
ment type, duration, format, clinician and delivery
mode, session frequency and length, control type, and
whether TAU was continued throughout the trial.
Meta-regressions were conducted from baseline to
postintervention due to limited data available to ana
lyze at the follow-up time points. We were unable to
perform meta-regressions on demographic characteris
tics and variables such as IBS subtype and symptom
severity due to inconsistent measurement and report
ing across studies.
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Quality of Life in IBS
(n = 1,308) compared with controls (n = 1,006). The
Results
PRISMA flow diagram is presented in Figure 1.
All data files and analysis code used for this study are
Summary of results for Objective 1: To compare the
provided at the following Open Science Framework
HRQoL of IBS patients with healthy controls.
project page: http://osf.io/7w2nv/.
Study Selection
Four thousand one hundred forty-seven articles were
retrieved from the database searches, with an addi
tional seven articles identified manually. Of these, 36
articles met inclusion criteria and the relevant data were
extracted. Eight studies compared HRQoL in those
with IBS (n = 822) with that of healthy individuals
(n = 3,809). Twenty-eight studies investigated HRQoL
in those with IBS following psychological intervention
Study Characteristics
Characteristics of the articles comparing HRQoL in
those with IBS with the healthy population are presented
in Table 3. Most studies appeared to use a cross-section
al design. The majority of the studies utilized the Rome
Criteria to establish diagnosis of IBS (k = 6), whereas the
other two studies utilized the International Classification
of Diseases, Tenth Revision (ICD-10) (Faresjo & Faresjo,
2010) and Manning criteria (Halder et al., 2004). Only
FIGURE 1. PRISMA 2009 flow diagram. IBS = irritable bowel syndrome; QoL = Quality of Life; RCT = randomized
controlled trial.
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TABLE 3. Characteristics of Studies That Assessed HRQoL in Patients With IBS in Comparison
With Healthy Controls
Authors
Country
Study Design
N
IBS
Participants (n)
Diagnostic
Criteria
Healthy
Controls (n)
HRQoL
Instrument
Ahmed et al.
Egypt
Case-control, descrip-
tive
9VTL00
IBS-QoL
Azpiroz et al.
Spain
4\S[PJLU[LYVIZLY]H-
tional, prospective
9VTL000
FDDQOL
-HYLZQHUK
-HYLZQ
Sweden
Epidemiological,
case-control
ICD-10
:-
Halder et al.
United
States
7VW\SH[PVUIHZLK
nested, case-control
Manning
:-
Huang et al.
China
Cross-sectional,
validation
9VTL00
IBS-QoL
3PL[HS
Canada
7VW\SH[PVUIHZLK
9VTL00
:-
3P\L[HS
China
Cross-sectional
9VTL000
IBS-QoL
9L`L[HS
Spain
Cross-sectional
9VTL00
:-
Note. FDDQOL =-\UJ[PVUHS+PNLZ[P]L+PZVYKLYZ8\HSP[`VM3PML8\LZ[PVUUHPYL"/98V3=OLHS[OYLSH[LKX\HSP[`VMSPML"0):=PYYP[HISL
IV^LSZ`UKYVTL"0):8V3=0YYP[HISL)V^LS:`UKYVTL8\HSP[`VM3PML0UZ[Y\TLU["ICD-10 =International Classification of Diseases,
Tenth Revision":-=0[LT:OVY[-VYT/LHS[O:\Y]L`":- = 0[LT:OVY[-VYT/LHS[O:\Y]L`
three studies (Ahmed, Mohamed, Sliem, & Eldein, 2011;
Huang, Zhou, Bushnell, Diakite, & Yang, 2007; Liu,
Xiao, Zhang, & Yao, 2014) utilized a disease-specific
HRQoL measure, this being the IBS-QoL (Patrick et al.,
1998) in each case.
Meta-Analyses
As shown in Table 4, all domains of HRQoL were
found to be statistically significantly poorer in IBS
samples relative to the healthy population. These
effects were large (d > 0.8) to moderate (d > 0.5) for
most domains. Of these effects, the largest was found
for activity interference (d = 2.16), followed closely
by health anxiety (d = 2.08), relationships (d =
2.06), and total HRQoL (d = 2.06). The number
of studies per meta-analysis ranges from two to three,
with meta-analyses with only one study not being able
to be conducted. Refer to Table 4 for further informa
tion regarding the specific number of studies in each
meta-analysis. Notably, the small number of effects per
meta-analysis results in large confidence intervals (CIs)
for the estimates of heterogeneity (I2); thus, interpreta
tion of these estimates is cautioned.
Meta-Regression Analyses
We performed meta-regression analyses to assess the
effect of potential moderators on domains of HRQoL
in studies comparing those with IBS with healthy con
trols. The number of domains on which analyses could
be conducted was limited. Of the moderators exam
ined, no significant moderation effects were found.
Summary of results for Objective 2: To examine psy
chotherapy-related changes in HRQoL of those with IBS.
Study Characteristics
Characteristics of studies examining HRQoL follow
ing psychological intervention are presented in Table 5.
Rome criteria were utilized unanimously throughout
the RCTs to aid diagnosis of IBS. Disease-specific
HRQoL measures were used in 22 of the studies, these
being the IBS-QoL (Patrick et al., 1998) and the
IBSQOL (Hahn et al., 1997). Seven trials utilized
generic measures, specifically, the SF-36 (Ware et al.,
1993), and one study conducted by Moss-Morris,
McAlpine, Didsbury, and Spence (2010) utilized the
Work and Social Adjustment Scale (WSAS) (Mundt
et al., 2002). A majority of the RCTs delivered multi-
modal psychological interventions, for example, expo
sure
and
mindfulness-based
CBT
(Ljotsson,
Andreewitch, et al., 2010; Ljotsson et al., 2011), or
psychotherapy with guided affective imagery (Boltin
et al., 2015). Cognitive-behavioral therapy was the
treatment of choice across most of the studies.
Risk of Bias
The ROB assessment for the RCTs is presented in
Table 6. Only two studies were determined to have a low
ROB across all domains (Boyce, Talley, Balaam, Koloski,
& Truman, 2003; Creed et al., 2003). Selective outcome
reporting and sequence generation were found to follow
accepted methods more generally. Allocation conceal
ment and blinding tended to be either attempted or not
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Page 8
Quality of Life in IBS
TABLE 4. Summary of Findings for HRQoL in
Irritable Bowel Syndrome Compared With
Healthy Individuals
HRQoL
Domain
k
Cohen's d (CI)
I2 (CI)
Activity inter-
ference
***
( [V
[V
Bodily pain
***
( [V
[V
Body image
***
([V
[V
Discomfort
1
NA
NA
Dysphoria
***
( [V
[V
Emotional role
limitations
***
( [V
[V
Diet
***
( [V
[V
General
health
* ( [V
[V
Health anxiety
***
([V
[V
Mental
composite
***
( [V
[V
Mental health
***
( [V
[V
Physical
composite
**
( [V
[V
Physical
functioning
***
( [V
[V
Physical role
limitations
***
( [V
[V
9LSH[PVUZOPWZ
***
( [V
[V
>
Sexual
1.99***
([V
[V
>
Social
functioning
***
( [V
[V
Social
reaction
**
([V
[V
>
Vitality
***
( [V
[V
Sleep
1
NA
NA
Total
**
( [V
[V
Note.(TL[HHUHS`ZPZ ^HZUV[JVUK\J[LKPM[OL[V[HSU\TILYVM
HZZVJPH[PVUZ H]HPSHISL ^LYL SLZZ [OHU *0 = JVUMPKLUJL
PU[LY]HS" /98V3 = OLHS[OYLSH[LK X\HSP[` VM SPML" I= indicator of
OL[LYVNLULP[`PUWLYJLU[HNLZIL`VUKJOHUJL"5(=UV[HWWSPJHISL
* p <
** p <
*** p <
adequately described to enable ROB to be assessed.
Many trials acknowledged the difficulty in ensuring
blinding in psychological interventions due to the nature
of such treatments. Overall, critical assessment of the
different domains outlined in the Cochrane Tool (Higgins
et al., 2011) demonstrated that ROB was evident across
the RCTs included in this meta-analysis and should be
considered when interpreting the current results.
Meta-Analyses
As shown in Table 7, the number of studies per meta-
analysis ranges from two to seven, reaching up to 24
when combined. Refer to Table 7 for the specific num
ber of studies contained in each meta-analysis. In those
with IBS, all domains of HRQoL were found to have
larger effect size improvements following psychological
intervention, as compared with the control group. The
magnitude of total HRQoL improvement across time
(post-treatment, Time 1, and Time 2 follow-up) was
significantly larger in those who received psychological
intervention, although these effects were small to mod
erate (Cohen's d = 0.49, 0.47, 0.41, respectively).
Effects for social functioning and social reaction were
relatively small with no significant difference in effect
size over time. Social role, however, was found to have
a small significant effect (d = 0.35), which was moder
ate and significant at Time 1 (d = 0.54). This effect was
small and nonsignificant at Time 2 (d = 0.25). Similarly,
a small to moderate significant effect was found for
relationships postintervention (d = 0.43) and a moder
ate nonsignificant effect was found at Time 1 (d = 0.57).
In relation to emotional HRQoL, a small nonsignifi
cant effect was found postintervention (d = 0.23),
whereas a moderate nonsignificant effect was evident at
Time 1 assessment (d = 0.54). At Time 2, the effect was
also moderate and significant (d = 0.52). Small nonsig
nificant effects were found for role limitations related
to emotional HRQoL across all three time points.
Those who received psychological intervention were
also found to have a greater change in dysphoria of
medium significant effect size (d = 0.64). At Time 2, this
effect was large and nonsignificant (d = 0.92). A small
significant effect was found for health anxiety postinter
vention (d = 0.46), with a moderate nonsignificant
effect demonstrated at Time 1 (d = 0.72). General
health resulted in a small nonsignificant effect following
treatment (d = 0.23), whereas a moderate significant
effect was found at Time point 1 (d = 0.65) and a small
significant effect evidenced at Time 2 (d = 0.45).
The mental composite domain was found to have a
small significant improvement postintervention (d =
0.34). This was also evidenced for the mental health
domain following intervention (d = 0.26) and at
Time 1 (d = 0.38). This effect was nonsignificant at
Time 2 (d = 0.28).
VOLUME 43 | NUMBER 3 | MAY/JUNE 2020
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Page 9
Quality of Life in IBS
TABLE 5. Characteristics of Studies That Assessed HRQoL in Patients With IBS in Response to
Psychological Intervention
Authors
Country
Diagnostic
Criteria
N
Intervention
Group (n)
Intervention:
1. Framework
2. Duration
3. Delivery Modality
4. Format
Control
Condition
(n)
Control
Condition
Framework
HRQoL
Instrument
(RIHYaHKLO
L[HS
Iran
9VTL000
1. Stress manage-
ment
^LLRZ
0UWLYZVU
5V[YLWVY[LK
TAU
IBS-QoL
Boltin et al.
Israel
9VTL000
1. Psychotherapy
with GAI
^LLRZ
0UWLYZVU
0UKP]PK\HS
19
>3*
IBS-QoL
Boyce et al.
Australia
9VTL0
1. CBT (TG1)
^LLRZ
0UWLYZVU
0UKP]PK\HS
9LSH_H[PVU[YHPU-
PUN;.
^LLRZ
0UWLYZVU
0UKP]PK\HS
TAU
:-
*YHZRLL[HS
United
States
9VTL00
1. CBT-interocep-
tive exposure
(TG1)
^LLRZ
0UWLYZVU
0UKP]PK\HS
1. CBT - stress
management
;.
^LLRZ
0UWLYZVU
0UKP]PK\HS
19
Support and
self-
monitoring
with psych-
oeducation
IBS-QoL
Creed et al.
England
9VTL0
1. Psychodynamic
IPT
^LLRZ
0UWLYZVU
0UKP]PK\HS
TAU
:-
Gaylord
L[HS
United
States
9VTL00
4):9
^LLRZ
0UWLYZVU
.YV\W
Support
group
IBS-QoL
Haghayegh
et al.
Iran
9VTL00
1. CBT
^LLRZ
0UWLYZVU
.YV\W
>3*
IBS-QoL
/LP[RLTWLY
L[HS
United
States
9VTL0
1. Comprehensive
CBT (TG1)
^LLRZ
0UWLYZVU
0UKP]PK\HS
)YPLM*);;.
:PUNSLZLZZPVU
0UWLYZVU
0UKP]PK\HS
TAU
IBSQOL
IBS-QoL
(continues)
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Page 10
Quality of Life in IBS
TABLE 5. Characteristics of Studies That Assessed HRQoL in Patients With IBS in Response to
Psychological Intervention (Continued)
Authors
Country
Diagnostic
Criteria
N
Intervention
Group (n)
Intervention:
1. Framework
2. Duration
3. Delivery Modality
4. Format
Control
Condition
(n)
Control
Condition
Framework
HRQoL
Instrument
Hunt et al.
United
States
9VTL00
1. CBT
^LLRZ
:LSMHKTPUPZ[LYLK
0UKP]PK\HS
>3*
IBS-QoL
Jang et al.
2VYLH
9VTL000
1. CBT
^LLRZ
0UWLYZVU
.YV\W
Psychoedu-
cation
IBS-QoL
Jarrett et al.
United
States
9VTL00
1. CSM (TG1)
^LLRZ
0UWLYZVU
0UKP]PK\HS
*:4;.
^LLRZ
;LSLWOVUL
0UKP]PK\HS
TAU
IBSQOL
Jarrett et al.
United
States
9VTL000
1. CSM
^LLRZ
0UWLYZVUHUKVY
telephone
0UKP]PK\HS
TAU
IBSQOL
3HI\ZL[HS
United
States
9VTL00
1. Psychoeducation
^LLRZ
0UWLYZVU
.YV\W
>3*
IBSQOL
3HJRULYL[HS
United
States
9VTL00
1. CBT (TG1)
^LLRZ
0UWLYZVU
.YV\W
1. Psychoeducation
;.
^LLRZ
0UWLYZVU
.YV\W
>3*
IBS-QoL
Lindfors et al.
Trial 1
Sweden
9VTL00
1. Gut-directed
hypnotherapy
^LLRZ
0UWLYZVU
0UKP]PK\HS
Supportive
therapy
IBSQOL
Lindfors et al.
;YPHS
Sweden
9VTL00
1. Gut-directed
hypnotherapy
^LLRZ
0UWLYZVU
0UKP]PK\HS
>3*
:-
3Q}[ZZVU
-HSRL[HS
"
3Q}[ZZVU
et al.
Sweden
9VTL000
1. Exposure and
mindfulness-
IHZLK*);
^LLRZ
0U[LYUL[
0UKP]PK\HS
>3*
IBS-QoL
3Q}[ZZVUL[HS
Sweden
9VTL000
,_WVZ\YLIHZLK
CBT
^LLRZ
0U[LYUL[
0UKP]PK\HS
Stress
management
IBS-QoL
(continues)
VOLUME 43 | NUMBER 3 | MAY/JUNE 2020
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Page 11
Quality of Life in IBS
TABLE 5. Characteristics of Studies That Assessed HRQoL in Patients With IBS in Response to
Psychological Intervention (Continued)
Authors
Country
Diagnostic
Criteria
N
Intervention
Group (n)
Intervention:
1. Framework
2. Duration
3. Delivery Modality
4. Format
Control
Condition
(n)
Control
Condition
Framework
HRQoL
Instrument
3Q}[ZZVUL[HS
Sweden
9VTL000
,_WVZ\YLIHZLK
CBT
^LLRZ
0U[LYUL[
0UKP]PK\HS
>3*
IBS-QoL
Moser et al.
Austria
9VTL000
1. Gut-directed
hypnotherapy
^LLRZ
0UWLYZVU
.YV\W
Supportive
[HSRZ
:-
Moss-Morris
L[HS
England
9VTL0
and II
1. CBT self-
management
^LLRZ
:LSMHKTPUPZ[LYLK
0UKP]PK\HS
TAU
>:(:
Oerlemans
L[HS
Netherlands
9VTL00
1. CBT
^LLRZ
0U[LYUL[
0UKP]PK\HS
TAU
IBS-QoL
9VILY[ZL[HS
England
9VTL00
1. Hypnotherapy
^LLRZ
0UWLYZVU
0UKP]PK\HS
TAU
IBS-QoL
Sanders et al.
United
States
9VTL00
1. CBT
^LLRZ
:LSMHKTPUPZ[LYLK
0UKP]PK\HS
11
>3*
IBS-QoL
:OPUVaHRP
L[HS
Japan
9VTL00
11
1. Autogenic
training
^LLRZ
0UWLYZVU
0UKP]PK\HS
Psychoedu-
cation
:-
;OHR\YL[HS
United
States
9VTL000
1. EAET (TG1)
^LLRZ
0UWLYZVU
0UKP]PK\HS
9LSH_H[PVU[YHPU-
PUN;.
^LLRZ
0UWLYZVU
0UKP]PK\HS
>3*
IBS-QoL
;RHJO\RL[HS
Canada
9VTL
\UZWLJPALK
1. CBT
^LLRZ
0UWLYZVU
.YV\W
Symptom
monitoring
with
support
:-
ALYUPJRLL[HS
Canada
9VTL000
4):9
^LLRZ
0UWLYZVU
.YV\W
TAU
IBS-QoL
Note.>OLYLZ[\KPLZPUJS\KLKTVYL[OHUVUL[YLH[TLU[NYV\WNYV\WZHYLPKLU[PMPLKHZ;.HUK;.[YLH[TLU[.YV\WHUK.YV\W
YLZWLJ[P]LS`HUKZWHUHJYVZZT\S[PWSLYV^Z^P[OPU[OL[HISL3PUKMVYZL[HSHWWLHYZ[^PJLHZ[OPZHY[PJSLPUJS\KLZ[^VZLWHYH[L
[YPHSZKLUV[LKHZ;YPHSHUK;YPHS3Q}[ZZVU-HSRL[HSHUK3Q}[ZZVUL[HSHYLJSHZZPMPLKHZ[OLZHTLZ[\K`W\ISPZOLK
across two articles. CBT = JVNUP[P]LILOH]PVYHS[OLYHW`"*:4 =JVTWYLOLUZP]LZLSMTHUHNLTLU[",(,; = emotional awareness
L_WYLZZPVU [YHPUPUN" .(0 =N\PKLK HMMLJ[P]LPTHNLY`" /98V3 = OLHS[OYLSH[LK X\HSP[` VM SPML"0):8V3 = 0YYP[HISL )V^LS :`UKYVTL
8\HSP[`VM3PML0UZ[Y\TLU["07;=PU[LYWLYZVUHSWZ`JOV[OLYHW`"4):9=TPUKM\SULZZIHZLKZ[YLZZYLK\J[PVU":- = 0[LT:OVY[
-VYT/LHS[O:\Y]L`";(<=[YLH[TLU[HZ\Z\HS">3*=^HP[SPZ[JVU[YVS">:(:=>VYRHUK:VJPHS(KQ\Z[TLU[:JHSL
E112 Copyright (c) 2020 Society of Gastroenterology Nurses and Associates
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Page 12
Quality of Life in IBS
TABLE 6. Risk of Bias Assessment for Randomized Controlled Trials Investigating
Health-Related Quality of Life in Irritable Bowel Syndrome Following Psychological Intervention
Authors
Sequence
Generation
Allocation
Concealment
Blinding
Incomplete Outcome
Data
Selective Outcome
Reporting
(RIHYaHKLOL[HS
)VS[PUL[HS
)V`JLL[HS
*YHZRLL[HS
*YLLKL[HS
.H`SVYKL[HS
1
/HNOH`LNOL[HS
1
1
/LP[RLTWLYL[HS
1
/\U[L[HS
1
1HUNL[HS
1HYYL[[L[HS
1
1HYYL[[L[HS
1
3HI\ZL[HS
3HJRULYL[HS
1
3PUKMVYZL[HS;YPHS
3PUKMVYZL[HS;YPHS
3Q}[ZZVU-HSRL[HS
3Q}[ZZVUL[HS
1
3Q}[ZZVUL[HS
1
4VZLYL[HS
4VZZ4VYYPZL[HS
1
6LYSLTHUZL[HS
9VILY[ZL[HS
1
:HUKLYZL[HS
1
:OPUVaHRPL[HS
1
;OHR\YL[HS
;RHJO\RL[HS
1
ALYUPJRLL[HS
Note.=SV^YPZRVMIPHZ"=OPNOYPZRVMIPHZ"HUK=\UHISL[VHZZLZZYPZRVMIPHZ3PUKMVYZL[HSHWWLHYZ[^PJLHZ[OPZHY[PJSL
PUJS\KLZ[^VZLWHYH[L[YPHSZKLUV[LKHZ;YPHSHUK;YPHS3Q}[ZZVUL[HSKVLZUV[HWWLHYPU[OPZ[HISLHZP[JVU[HPUZMVSSV^\W
KH[HMYVT3Q}[ZZVU-HSRL[HSHUKHZZ\JOOHZUV[ILLU[YLH[LKHZHZLWHYH[L[YPHS
Small significant effects were evident at all three time
points for physical functioning (d = 0.24, 0.43, and
0.36, respectively), whereas small significant effects
were found for physical composite postintervention
(d = 0.38). Physical role limitations demonstrated a
small significant effect following treatment (d = 0.35), a
moderate significant effect at Time 1 (d = 0.52), and a
small significant effect at Time 2 (d = 0.34).
Significant small to moderate effects were found for
domains of vitality (d = 0.31, 0.51, and 0.50, respec
tively) and diet (d = 0.33, 0.60, and 0.26, respectively)
across time. Similarly, effect sizes for sleep were small
and significant at each time point (d = 0.26, 0.32, and
VOLUME 43 | NUMBER 3 | MAY/JUNE 2020
0.48, respectively). There is uncertainty in the hetero
geneity estimates across all individual domains of
HRQoL, evident in the wide I2 CIs; thus, interpreta
tion of these estimates is cautioned.
Notably, the studies by Moser et al. (2013) and
Jang, Hwang, and Kim (2014) included two follow-up
assessment time points (3 and 4 months, respectively)
that fell within Time 1 parameters (i.e., 3-6 months).
As noted previously, we used the longest time point for
all analyses (i.e., 6 months in both cases). A sensitivity
analysis was conducted, whereby our results were com
pared with the results that would be obtained if we had
used the alternate time points. Our sensitivity analyses
E113
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TABLE 7. Summary of Findings for HRQoL in Irritable Bowel Syndrome Following Psychological Intervention
E114 Copyright (c) 2020 Society of Gastroenterology Nurses and Associates
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Quality of Life in IBS
HRQoL Domain
Baseline to Postintervention
Baseline to Time 1 Assessment
Baseline to Time 2 Assessment
k
Cohen's d (CI)
I 2 (CI)
k
Cohen's d (CI)
I 2 (CI)
k
Cohen's d (CI)
I 2 (CI)
Activity interference
[V
[V
[V
[V
1
NA
NA
Bodily pain
[V
[V
[V
[V
[V
[V
Body image
[V
[V
[V
[V>
1
NA
NA
Dysphoria
[V
[V
[V
[V>
1
NA
NA
Emotional
[V
[V
[V
[V>
* [V
[V>
Emotional role
limitations
[V
[V
[V
[V
[V
[V
Diet
[V
[V
* [V
[V
* [V
[V
General health
[V
[V
*** [V
[V
** [V
[V
Health anxiety
[V
[V
[V
[V>
1
NA
NA
Mental composite
[V
[V
NA
NA
1
NA
NA
Mental health
[V
[V
* [V
[V
[V
[V
Physical composite
[V
[V
NA
NA
1
NA
NA
Physical functioning
[V
[V
*** [V
[V
** [V
[V
Physical role
limitations
[V
[V
*** [V
[V
** [V
[V
9LSH[PVUZOPWZ
[V
[V
[V
[V>
1
NA
NA
Sexual
[V
[V
[V
[V
[V
[V
Social functioning
[V
[V
[V
[V
[V
[V
Social reaction
[V
[V
[V
[V>
1
NA
NA
Social role
[V
[V
*** [V
[V
[V
[V
Vitality
*** [V
[V
*** [V
[V
*** [V
[V
Sleep
* [V
[V
* [V
[V
** [V
[V
Total
*** [V
[V
*** [V
[V
*** [V
[V
Note.(TL[HHUHS`ZPZ^HZUV[JVUK\J[LKPM[OL[V[HSU\TILYVMHZZVJPH[PVUZH]HPSHISL^HZSLZZ[OHU*0= JVUMPKLUJLPU[LY]HS"/98V3=OLHS[OYLSH[LKX\HSP[`VMSPML"I=
PUKPJH[VYVMOL[LYVNLULP[`PUWLYJLU[HNLZIL`VUKJOHUJL"5(=UV[HWWSPJHISL
* p <
** p <
*** p <
Page 14
Quality of Life in IBS
largely yielded no differences in the interpretation of
findings based on this decision (i.e., magnitude, direc
tion, and statistical significance of findings were con
sistent). The one exception was for the HRQoL
domain of body image, for which the inclusion of the
4-month time point (Jang et al., 2014) resulted in sig
nificant therapy change at the Time 1 follow-up (d =
0.43, p = .04, 95% CI = 0.03-0.82). Given this spe
cific analysis involved only two effect sizes (see Table 7),
we are cautious in overinterpreting this difference.
Meta-Regression Analyses
We performed meta-regression analyses to assess the
effect of potential moderators on domains of HRQoL
in studies examining the effect of psychological inter
vention on HRQoL. The number of domains on which
analyses could be conducted was limited. Few modera
tors were found to be significantly related to the effect
sizes for any HRQoL domains.
For the HRQoL domain of activity interference, the
intervention effect size was significantly larger in stud
ies that used the Rome III diagnostic criteria, relative
to the Rome II criteria (p = .02).
For the HRQoL domain of diet, studies with a 6- to
10-week intervention duration (relative to 10+ weeks'
duration; p = .02) were found to have significantly
greater intervention effects. Similarly, studies that did
not clearly articulate whether TAU was continued or
discontinued throughout the trial (relative to studies
allowing TAU to be continued during the study; p =
.04) were also found to have significantly greater inter
vention effects. In addition, studies that relied primar
ily on self-report as the diagnostic method for IBS were
also found to have a significantly larger intervention
effect, relative to self-report diagnosis being confirmed
by a gastroenterologist or a physician (p = .04). No
other variables were found to significantly moderate
the effect sizes for any of the other HRQoL domains
that were able to be conducted (p > .05).
Discussion
This systematic review and meta-analysis provides a
timely summary of HRQoL outcomes in IBS. Previously
conducted reviews have predominantly focused on
treatment efficacy by measuring alterations in gastroin
testinal symptoms (Ford et al., 2008; Ford et al., 2014b;
Lackner et al., 2004; Laird, Tanner-Smith, Russell,
Hollon, & Walker, 2017; Webb et al., 2007). Although
this is important, HRQoL, a clinical indicator of psy
chosocial impairment, has not been given equivalent
attention. This article expands on previous reviews by
not only considering HRQoL as a singular construct but
also examining the individual domains that comprise it.
We also tested whether particular study and treatment
characteristics significantly moderated effect sizes.
VOLUME 43 | NUMBER 3 | MAY/JUNE 2020
Objective 1: To compare the domains of HRQoL of
individuals with IBS with those of healthy controls.
The current meta-analysis found support for the
association between IBS status and poor HRQoL, rela
tive to healthy individuals from the community. This is
consistent with previously conducted reviews (El-Serag
et al., 2002; Lackner et al., 2004). As IBS is an endur
ing diagnosis, HRQoL is a clinically relevant indicator,
informing gastroenterological nurses of the impacts of
IBS on one's psychosocial functioning (Ballou &
Keefer, 2017; Monnikes, 2011). Although this finding
is important, we recognize that it does not identify
specific variables that contribute to poor HRQoL in
those with IBS. It is unclear whether HRQoL varies on
the basis of age, gender, socioeconomic status, IBS
symptomology, or subtype. This was unable to be
examined because of inconsistent reporting of partici
pant characteristics between studies. It is also relevant
to note that, in cross-sectional research, participants
identified as having met criteria for IBS may not expe
rience symptoms that constitute a clinical diagnosis
(Lovell & Ford, 2012).
Objective 2: To examine psychotherapy-related
change in the domains of HRQoL of those with IBS.
The current review found evidence of less impair
ment in all domains of HRQoL following psychologi
cal intervention. Delivery of any type of psychological
treatment was superior to control conditions in rela
tion to HRQoL in IBS. It remains unclear whether
any one type of psychotherapy is more efficacious
than others (Brandt et al., 2009; Lackner et al.,
2004). Much heterogeneity exists between (and even
within) psychological interventions. This is largely
due to the diversity in content, format, and techniques
employed (Henrich et al., 2015; Zijdenbos et al.,
2009), as well as the tendency for clinical trials to
combine several treatment modalities. This makes
categorization, testing, and interpretation of the effi
cacy of interventions challenging, and highlights the
need for standardized interventions to be tested in IBS
cohorts.
The lack of standardization is the main barrier to
determining mechanisms by which treatments operate
(i.e., exogenous or endogenous; Henrich et al., 2015;
Ljotsson et al., 2013; Zijdenbos et al., 2009), as well
as the determination of subgroups of IBS patients who
may benefit from particular types of psychotherapy
(Boeckxstaens et al., 2016). Investigation of this was
beyond the scope of the current review and should be
considered for future studies, as it may aid in identify
ing which of the available interventions are most effi
cacious for desired outcomes among specific cohorts. It
may also help reduce the economic burden imposed by
IBS on healthcare systems, as those with IBS may be
able to be directed to effective therapy early on in their
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Page 15
Quality of Life in IBS
healthcare seeking, thus reducing the likelihood of
seeking out multiple interventions.
The current results also demonstrate limited consist
ency in findings across HRQoL domains. For example,
domains related to physical HRQoL (physical role
limitations, composite, and functioning) differed in
their association with therapy-related changes. This
was similar for domains related to mental and inter
personal HRQoL. This raises the question of whether
HRQoL itself is largely heterogeneous and, as such,
may not be suitable for investigation using a meta-
analytic approach. It also highlights the fact that
assessment of HRQoL in IBS captures broad areas of
psychosocial functioning, which may result in specific
behavioral impairment across domains being missed
(Ballou & Keefer, 2017). Health-related quality of life
domain categorization may require refinement in order
to better equip future researchers to identify relevant
patterns of impairment that can be addressed with
targeted intervention.
The size and significance of the current effects for
different HRQoL domains tended to vary across time.
Few domains demonstrated consistency or growth in
effect sizes from postintervention to longitudinal fol
low-up, and most often larger effects were evident at
the 3- to 6-month time point. It is unclear why effects
were maintained across time in particular domains
(e.g., emotional, vitality, sleep, and total) and not oth
ers (e.g., diet, general health, and social role). It is pos
sible that sampling error, in the limited number of
studies available for meta-analysis at follow-up Time 1
and 2 (3-6 months and 6-12 months, respectively),
contributed to this outcome. As such, the current find
ings indicate the efficacy of psychological intervention
in the short term; however, it is unclear whether these
effects can be sustained beyond the treatment period.
Further research is required to determine the longevity
of psychotherapeutic benefits in the context of persis
tent IBS (Canavan, West, & Card, 2014; Laird et al.,
2016).
Impact of Bias
Risk of bias was evident across the majority of studies
included in the current review. This is largely related to
the difficulty inherent in blinding participants in psy
chological trials, which is a common methodological
concern. This can be addressed in future trials through
the use of independent assessors who are unaware of
the intervention being tested (Irvine et al., 2006).
Despite much data supporting the efficacy of psycho
logical interventions in IBS, no studies have reported
on adverse effects that may occur through psycho
therapy, which may indicate reporting bias (Brandt
et al., 2009). Further publication bias may exist in tri
als included in the current review, as CBT appears to
be saturating the investigation of psychotherapy for
IBS. Exploration of different interventions is encour
aged. Future studies are also recommended to better
adhere to published guidelines for IBS treatment trials
in order to enable pooling of results with minimal het
erogeneity (Irvine et al., 2006; Zijdenbos et al., 2009).
Meta-Regression
Meta-regression revealed few significant moderation
effects. Diagnostic criteria, specifically Rome III,
appeared to buffer the relationship between psycho
logical intervention and HRQoL related to activity
interference. It is possible that due to the increased
sensitivity of Rome III in accurately identifying those
suffering from IBS, participants in trials that utilized
the more recent Rome criteria were more representa
tive of the IBS population (Drossman, 2016). As such,
larger treatment effects may have been found, as psy
chological treatments targeting factors specifically
related to IBS were delivered to appropriate samples.
Future studies are recommended to employ updated
versions of the Rome criteria (the most recent being the
Rome IV; Drossman et al., 2016) to enable further
understanding of outcomes in relation to the diagnos
tic criteria employed.
Studies with an intervention duration of 6-10
weeks, as compared with 10 weeks or more, had larger
intervention effects in the domain of HRQoL related
to diet. Intervention duration in IBS has traditionally
been based on frequency and duration of symptoms
(Irvine et al., 2006). The variable and episodic nature
of IBS makes recommendations about intervention
duration difficult to operationalize (Irvine et al., 2006).
For the majority of those with IBS, symptom flares and
remissions generally last less than 1 week (Hahn,
Watson, Yan, Gunput, & Heuijerjans, 1998; Su, Shih,
Presson, & Chang, 2014; Tillisch et al., 2005), which
may at least partly explain why participants are more
likely to adhere to shorter interventions. This is con
sistent with recent findings of the efficacy of brief
interventions in IBS cohorts (Heitkemper et al., 2004;
Hunt, Ertel, Coello, & Rodriguez, 2015; Hunt,
Moshier, & Milonova, 2009). Further research is
needed on the natural history of IBS to enable clearer
trial guidelines regarding treatment duration (Irvine
et al., 2006).
Within the HRQoL domain relating to diet, the use
of self-report to diagnose IBS, as compared with diag
nosis having been confirmed by a gastroenterologist or
a physician, also resulted in larger intervention effects.
There exists a lack of information on potential differ
ences in patient characteristics between those who self-
report an IBS diagnosis and those who have their
diagnosis confirmed by a clinician. It is possible that
participants differ on the basis of symptom frequency,
E116 Copyright (c) 2020 Society of Gastroenterology Nurses and Associates
Gastroenterology Nursing
Copyright (c) 2020 Society of Gastroenterology Nurses and Associates. Unauthorized reproduction of this article is prohibited.
Page 16
Quality of Life in IBS
level of psychosocial impairment, and healthcare utili
zation (Chang & Jones, 2003; Drossman, Camilleri,
Mayer, & Whitehead, 2002; Lee et al., 2008). This
poses the question of how representative samples con
sisting of those who self-report their diagnosis of IBS
actually are.
Furthermore, in the HRQoL domain of diet, studies
that did not clearly describe whether TAU was contin
ued throughout the trial also demonstrated larger
effects, relative to those that explicitly reported that
TAU had been continued. Future studies are encour
aged to clearly operationalize TAU and describe its
continuation or cessation for the duration of the trial.
Treatment external to the immediate intervention has
the potential to confound outcomes and without clari
fication, cannot be tested as a possible modifier of the
intervention effect (Irvine et al., 2006), thus preventing
meaningful interpretation. The limited number of stud
ies precludes robust inferences to be drawn about
potential moderators. Further studies are needed to
determine whether these factors are important influ
encers of the magnitude of HRQoL outcomes follow
ing psychological interventions.
Strengths
The current systematic review and meta-analysis uti
lized methodology that closely adhered to established
guidelines (Moher et al., 2015), including reporting of
the search strategy and inclusion criteria. Dual data
extraction reduced the possibility of bias through a
single reviewer influencing the results and of key data
being missed. Abstracts were excluded on the basis
that they are not subjected to peer review and do not
include the level of methodological detail and reported
outcomes necessary for inclusion. Nonetheless, it is
possible that this imposed a degree of publication bias
in the current results. We attempted to avoid this by
conducting extensive searches for all published studies
both electronically and manually. Where data were
unclear or missing, authors were contacted to ensure
that all relevant published articles were identified and
included. It is unlikely that a published study of suffi
cient magnitude to influence the results has been
missed.
Limitations
Despite the careful methodology, followed by the
authors, the nature of the IBS literature available for
synthesis is limited by factors which may influence the
current results. The majority of the research involves
those with moderate to severe IBS recruited from ter
tiary referral settings (El-Serag et al., 2002). This limits
the generalizability of the current findings and there
fore may not be applicable to those who experience
milder IBS, do not seek medical care, or are recruited
VOLUME 43 | NUMBER 3 | MAY/JUNE 2020
from community settings. These individuals may have
a shorter symptom duration, which may mean that
they experience greater improvement in HRQoL fol
lowing intervention compared with clinical samples
(Lovell & Ford, 2012). Unfortunately, we were unable
to statistically analyze severity between study samples
due to variability in its measurement and classification.
Furthermore, the recruitment settings of included stud
ies were most often an undefined combination of pri
mary, secondary, and tertiary, which did not allow
differentiation of participants based on recruitment
source.
Identification of true effects was also challenged by
variations in control and treatment groups. For exam
ple, all participants in a study conducted by Boltin
et al. (2015) were referred to a dietician prior to com
mencement of trial conditions, whereas Ljotsson, Falk,
et al. (2010) offered both control and treatment groups
access to separate discussion forums in which partici
pants were able to discuss treatment with one another.
Treatment delivered by Zernicke et al. (2013) was also
possibly confounded by incorporating yoga into a trial
of MBSR based on a protocol informed by Kabat-Zinn
(2013). Moreover, only some studies made reference to
an intervention protocol, leaving the validity of adopt
ed interventions questionable.
Most studies also contained insufficient information
about clinical characteristics (e.g., IBS symptom dura
tion or subtype), and inclusion and exclusion criteria
were often inconsistent in relation to comorbidities
and TAU (which in itself is likely to be heterogeneous).
On the basis that comorbid gastrointestinal conditions
would likely confound HRQoL outcomes, the current
authors attempted to exclude studies that did not
screen for this at recruitment; however, due to the lack
of stringent criteria across the individual trials, it is
possible that this was not consistently accomplished.
Because of the limited number of studies in the meta-
analysis, it was also difficult to examine heterogeneity.
Finally, the current review did not include non-English
language studies, which may have introduced a degree
of publication bias.
Future Directions
The current data demonstrate that HRQoL is an
important factor that is significantly compromised in
IBS populations, yet one that is amenable to psycho
logical intervention. It is recommended that large-scale
RCTs are conducted, incorporating the following fea
tures: improved reporting and addressing areas that
may pose ROB, using standardized and current criteria
to diagnose clinical presentations of IBS (i.e., Rome IV;
Drossman et al., 2016), adhering to clear inclusion and
exclusion criteria, and assessing participants in both
treatment and control groups across all HRQoL
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Page 17
Quality of Life in IBS
domains at extended intervals to ascertain the longev
ity of treatment effects.
In addition, research involving participants recruit
ed from distinct settings (i.e., primary, secondary, or
tertiary) will enable identification of differences in
HRQoL impairment. Psychotherapy is often consid
ered only for those with refractory IBS who have found
other interventions unsuccessful and is rarely trialed in
those from primary settings with newly diagnosed IBS
(Ford, Talley, Schoenfeld, Quigley, & Moayyedi, 2009).
Given the low and inconsistent effects found for phar
macological treatment and general medical or lifestyle
management, it is appropriate to consider testing a
new approach for the improvement of IBS earlier in the
syndromes trajectory (Ford et al., 2009; Ljotsson et al.,
2014). Data from large, well-designed, randomized tri
als are needed before these recommendations can be
applied and implemented by gastroenterological nurses
(Ford et al., 2009).
It would also be advantageous for future research to
be explicit in the reporting and implementation of psy
chological treatment. Not only would this enable the
determination of whether a particular type of therapy
is efficacious as compared with others, it may also
clarify the direction for further investigation into the
mechanisms through which these interventions operate.
Although this may pose challenges related to the avail
ability of trained nurses in the short term (Ford et al.,
2014a), this can be overcome with focused training for
gastroenterological nurses in real-world settings.
Trials comparing psychological interventions, as
opposed to utilizing waitlist control conditions, may
also be beneficial. Much like treatment conditions,
there also exists a large amount of variation in control
conditions. As placebo response in IBS trials is high, it
is important to address expectancy effects and deter
mine whether observed change can be attributed to the
intervention itself (Zijdenbos et al., 2009). We acknowl
edge that in therapeutic trials, it is not possible to
entirely separate these effects.
Finally, although it is a common practice to examine
symptom severity as the primary outcome in trials of
psychological treatments for IBS (Webb et al., 2007),
we recommend that the use of both generic and
disease-specific HRQoL assessment tools be consid
ered. This will enable further insight into the impact of
IBS on HRQoL, as well as comparisons across other
chronic conditions to which IBS populations have been
found to have comparable HRQoL impairment
(El-Serag et al., 2002; Gralnek, Hays, Kilbourne,
Naliboff, & Mayer, 2000).
Summary and Conclusions
This systematic review and meta-analysis provides an
examination of HRQoL in IBS, demonstrating
noticeable impairment compared with healthy coun
terparts but improved HRQoL following psychologi
cal intervention. Investigation of HRQoL is a priority,
as it enables gastroenterological nurses to understand
the individual's psychosocial deficiencies and informs
the application of psychological intervention for IBS.
Research that is replicable and generalizable is needed
to further our existing knowledge on how IBS contrib
utes to poor HRQoL and how change through psycho
logical intervention can be achieved and sustained.
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