Brief Report: Barriers to Treatment Adherence in Pediatric
Inflammatory Bowel Disease
Kevin A. Hommel,1,2,3PHD, and Robert N. Baldassano,4,5MD
1Center for the Promotion of Treatment Adherence and Self-Management,2Cincinnati Children’s Hospital
Medical Center,3University of Cincinnati College of Medicine,4University of Pennsylvania School of Medicine,
and5The Children’s Hospital of Philadelphia
treatment and their relationship with adherence using a combined forced choice and semi-structured
interview assessment approach. Methods Sixteen adolescents with IBD and their parents participated in
an open-ended interview regarding adherence barriers and completed quantitative measures of adherence,
barriers to treatment, and disease severity. Results
were forgetting, interference with other activities, difficulty swallowing pills, and not being at home.
Number of reported barriers was positively correlated with objective nonadherence for 6-MP/azathioprine.
Nonadherence frequency was 42% for 6-MP/azathoprine and 50% for 5-ASA medications.
Conclusions Using a combined assessment approach, patients and parents reported several barriers to
treatment adherence that are appropriate for clinical intervention. This is critical given the significant
medication nonadherence observed in this sample and the relationship between total number of barriers
and disease management problems.
To examine perceived barriers to medication adherence in inflammatory bowel disease (IBD)
The most commonly identified barriers to adherence
Key wordsadherence; barriers; compliance; inflammatory bowel disease; medication.
Inflammatory bowel disease (IBD), comprised of Crohn’s
disease and ulcerative colitis, is diagnosed in approxi-
mately 71 of 100,000 individuals in the United States
(Kappelman et al., 2007) and approximately one-quarter
of patients are diagnosed during childhood or adolescence.
Disease features of IBD include chronic, intermittent
inflammation of the gut; diarrhea; abdominal pain; and
growth failure. Treatment of IBD primarily involves the
use of oral medications, which may vary in dosing
frequency and number of pills to be taken by patients
per dose. This, combined with negative side effects
(e.g., weight gain) of adjunctive medications such as pred-
nisone and an unpredictable disease course, presents
significant self-management challenges to children and
Treatment adherence is a significant health concern
in pediatric chronic illness management, with 50–75% of
children and adolescents not adhering adequately to their
prescribed regimens(Logan, Zelikovsky,Labay,&
Spergel, 2003; Rapoff, 1999). Data on adherence in the
pediatric IBD population is limited but consistent with
other pediatric populations, with nonadherence prevalence
ranging from 50% to 88% depending on the medication
and method of assessment (Hommel, Davis, & Baldassano,
2008, 2009; Mackner & Crandall, 2005b; Oliva-Hemker,
Abadom, Cuffari, & Thompson, 2007; Riekert & Drotar,
2002). While these data clearly demonstrate that adher-
ence is a significant challenge for children and adolescents
with IBD, it does not provide insight into the particular
barriers that might prevent patients and families from
taking their medication as prescribed.
Barriers to treatment adherence have been examined
in several pediatric populations. Much of this research
has identified similar barriers including forgetting, taste/
palatability issues, oppositional behavior, side effects,
time constraints, failure to refill prescriptions, organiza-
tional difficulties, and interference with other activities
in populations such as cystic fibrosis and asthma
All correspondence concerning this article should be addressed to Kevin A. Hommel, PhD, Cincinnati Children’s
Hospital Medical Center, Center for the Promotion of Treatment Adherence and Self-Management, Division of
Behavioral Medicine and Clinical Psychology, 3333 Burnet Ave. – MLC 7039, Cincinnati, OH 45229-3039, USA.
Journal of Pediatric Psychology 35(9) pp. 1005–1010, 2010
Advance Access publication December 21, 2009
Journal of Pediatric Psychology vol. 35 no. 9 ? The Author 2009. Published by Oxford University Press on behalf of the Society of Pediatric Psychology.
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(Modi & Quittner, 2006), sickle cell disease (Witherspoon
& Drotar, 2006), and transplant recipients (Simons &
Blount, 2007). Moreover, there is evidence that increased
number of barriers is related to poorer adherence (Logan
et al., 2003; Riekert & Drotar, 2002). A recent study
in IBD reported that forgetting, being away from home,
and interference with activities were the most common
barriers to adherence, and that greater number of barriers
were correlated with poorer self-reported adherence
(Ingerski, Baldassano, Denson, &
However, this study relied exclusively on forced-choice
quantitative data, and the self-reported adherence esti-
mates were likely overestimated by participants (Ingerski
et al., 2009). Reliance on forced choice measures alone,
which is common in adherence research, may result in
some barriers being missed if they were not included
in the questionnaire. Moreover, the use of both deductive
and inductive methodologies provides a complementary
focus on a specific behavioral process such as treatment
adherence, and may enhance data accuracy as a result.
At this early stage of adherence research in IBD, it is
important to get both quantitative and qualitative data
regarding barriers to treatment adherence so that the
development of interventions can consider all possible
factors and target the most salient barriers contributing
to poor adherence. Thus, the primary objective of this
study was to examine patient- and parent-reported barriers
to treatment adherence in IBD using a quantitative
forced-choice questionnaire as well as a qualitative
open-ended interview assessment in order to obtain com-
prehensive data on barriers in this population. A secondary
objective was to examine the relationship between the
Consistent with prior research, it was anticipated that
greater number of perceived barriers would be positively
correlated with nonadherence.
Participants and Procedure
Inclusion criteria for this study were: (a) diagnosis of
Crohn’s disease or ulcerative colitis, (b) 13–17 years of
age, (c) current prescription of 6-mercaptopurine (6-MP)/
azathioprine and 5-aminosalicylic acid (5-ASA), which are
the two most commonly prescribed types of medication
for IBD, and (d) English fluency for patients and parents.
Exclusion criteria were: (a) diagnosis of pervasive develop-
mental disorder and (b) comorbid chronic illness. Eighteen
consecutive patients who met eligibility criteria were
recruited; two declined participation (one was not
interested and one did not have enough time). Thus, the
final sample was comprised of 16 adolescents and their
Participants were recruited from a pediatric IBD treat-
ment center in the northeastern United States. Patients
were identified via medical chart review and approached
during clinic appointments. After informed consent and
assent was obtained, participants completed quantitative
measures of adherence and treatment barriers, followed
by an open-ended interview designed to elicit discussion
by parents and adolescents regarding treatment adherence.
Study personnel completed disease severity assessments
using patient chart note data and laboratory values
from the clinic appointment corresponding to the study
visit. Total time for participation was approximately
30–60min. Participants were compensated $50. This
study was approved by the Institutional Review Board.
Treatment Adherence Interview
An interview designed for this study utilizing open-ended
questions was used to elicit patient- and parent-generated
responses regarding treatment adherence barriers across
educational (e.g., knowledge of regimen), organizational
(e.g., placement of medication in house), and behavioral
(e.g., refusal to take medication) domains. Individual
(i.e., patient-parent dyads) interviews were chosen rather
than focus groups in order to avoid consensus effects on
qualitative data integrity. Interviews were administered
jointly to patients and parents. Example discussion ques-
tions include: ‘‘Tell me about your medication regimen
and how each medication is supposed to work,’’ ‘‘How
is your medication organized and who is in charge of
making sure medication is taken?’’ and ‘‘What kinds of
things get in the way or prevent you from taking your
Medical Adherence Measure
The Medical Adherence Measure (MAM) (Zelikovsky &
Schast, 2008) is a structured interview-based assessment
of patient knowledge, adherence behaviors, organizational
systems, and barriers to disease management over the
past week. Participants indicate whether they perceive
each of 12 common barriers to impact their adherence.
The measure also asks respondents to report the number
of doses of particular medications they have missed in
the past seven days. Study personnel administered the
measure jointly to patients and caregivers. The MAM
(Zelikovsky & Schast, 2008; Zelikovsky, Schast, Palmer,
& Meyers, 2008).
reliability and validity
Hommel and Baldassano
Study personnel conducted pill counts of medications
prescribed to the patient during the clinic visit (or via
telephone within 48hr of the clinic visit if the patient
did not bring his/her medications to clinic). Prior research
has demonstrated no significant differences between
pill counts conducted in person compared to telephone
1989). Consistent with prior research, adherence was
restricted to 0–100% (Modi & Quittner, 2006) to minim-
ize error resulting from dumping and/or combining of pills
for each medication.
Pediatric Crohn’s Disease Activity Index
The Pediatric Crohn’s Disease Activity Index (PCDAI)
(Hyams et al., 1991) is a well-established and validated
disease severity assessment for pediatric Crohn’s disease.
Scores range 0 to 100, with higher scores representing
more severe disease, and the measure includes subjective
criteria (e.g., pain), objective criteria (e.g., physical exam),
<15¼inactive disease; 15–30¼mild to moderate disease,
and >30¼severe disease activity (Otley et al., 1999).
Lichtiger Colitis Activity Index
The Lichtiger Colitis Activity Index (LCAI; Lichtiger et al.,
1994) is a validated disease severity measure for ulcerative
colitis. It is scored 0–21, with higher scores representing
more severe disease, and eight ulcerative colitis related
variables including number of daily stools, nocturnal diar-
rhea, visible blood in stool, fecal incontinence, abdominal
pain or cramping, general well-being, abdominal tender-
ness, and need for antidiarrheal medication are assessed.
Data Management and Analyses
Interviews were conducted by a doctoral level licensed
clinical psychologist. These interviews were 20–45min
in duration; audio recordings were transcribed by a profes-
sional transcriptionist and checked for accuracy by the
interviewer. NVivo 7 software was used for qualitative
data coding and analyses. Two trained master’s level
psychology graduate students coded transcripts under
the supervision of the principal investigator. Quantitative
data were analyzed using SPSS 17.0 software. Descriptive
statistics were performed for demographic data, disease
severity, adherence, and adherence barriers data. PCDAI
and LCAI disease severity scores were treated as continu-
ous variables for analyses. Nonadherence frequency
was calculated as: 100 – (number of pills taken/number
of pills prescribed?100). Nonadherence prevalence was
defined as the percent of the sample taking <80% of a
medication. Bivariate correlations were conducted to
determine the relationship between perceived barriers
and adherence frequency.
Adolescents (11 male, 5 female) had a mean age of 15.75
years (SD¼1.08 years); 94% were diagnosed with Crohn’s
disease and 6% with ulcerative colitis. Ninety-four percent
of participants were Caucasian and 6% African American.
The modal annual household income category was
$75,001–$100,000 and the majority of parents had at
least a bachelor’s degree (62.5% of mothers; 56.3% of
fathers). Mean parental age was 46.44 years for mothers
and 48.81 years for fathers, and 81.3% of mothers and
75% of fathers were married. Inter-rater reliability for quali-
tative data, calculated as percent agreement between
coders, was 90%. Mean disease severity was in the mild
to inactive range for the PCDAI (10.67) and LCAI (7.00).
Mean pill count nonadherence frequency for 6-MP/
azathioprine was 42% (SD¼26.34); nonadherence preva-
lence was 81.3% for 6-MP/azathioprine. Pill count nonad-
herence frequency for 5-ASA was 50% (SD¼23.61);
nonadherence prevalence was 93.3% for 5-ASA. On the
MAM, mean nonadherence
azathioprine and 5-ASA were 8% (SD¼17.49) and 5%
(SD¼7.01), respectively. Nonadherence prevalence for
both 6-MP/azathioprine and 5-ASA was 13% on the MAM.
Ten of the 12 barriers to treatment adherence on the
MAM were reported by participants (‘‘hate the taste’’
and ‘‘other’’ were not). The most commonly reported bar-
riers reported on the MAM were ‘‘just forget,’’ ‘‘wasn’t
home,’’ and ‘‘interferes with activity.’’ Number of barriers
reported ranged from 2 to 5 with a mean of 3.44. There
was a moderate positive correlation between number of
reported barriers on the MAM and objective pill count
nonadherence frequency for 6-MP/azathioprine (Table I).
Table I. Correlations Between Reported Barriers and Nonadherence
1. Number of reported barriers
2. 5-ASA MAM Nonadherence
3. 6-MP/azathioprine MAM Nonadherence
4. 5-ASA Pill Count Nonadherence
5. 6-MP/azathioprine Pill Count Nonadherence
Barriers to Adherence in IBD
Qualitative analyses of interview data revealed that the
most commonly reported barriers were ‘‘forgetting,’’
‘‘other activities,’’ and ‘‘difficulty swallowing pills.’’
Additional barriers (Table II) emerged from qualitative
data that could not have been reported and analyzed quan-
titatively. Patients and parents reported that the regimen
complexity (e.g., number of medications and pills per
dose) acted as a barrier to adherence and occasionally
resulted in arbitrary changes to regimens by parents or
patients as noted here.
Mother of 14y/o male: ... the calcium is just a sup-
plement that we’re giving him and he can have it
three times a day to get the maximum amount and
not too long ago, I just took away the morning one.
...that’s a pretty big pill and so I said to him, let’s
just back off on that one.
16y/o female: Um, well, at first it was difficult cause
I had to take, like, over twenty pills a day, and I just
didn’t want to. So, I skipped it a lot.
Another issue that emerged as a barrier to adherence
was patient perceptions of how effective the medication is
at relieving symptoms immediately.
17y/o female: ... it’s hard I think with this stuff
cause, if I don’t take it, I don’t see an immediate,
like, effect from not taking it. Like, it doesn’t feel
like it’s a problem missing it.
16y/o female: ... I guess I think I don’t need to take
my medicine because, you know, I’ve felt fine for
over a year. So, if I miss a few days, it won’t hurt
me at all, but I guess in the long run it could cause
Finally, embarrassment from taking medication in
front of peers was reported as a barrier to adherence.
Mother of 14y/o male: ... I just think it’s one of
those things where his friends aren’t on medication.
And I’ll have to bring it to a sleep-over, and it’s
This is the first study to incorporate both quantitative and
qualitative assessments of barriers to medication adherence
in pediatric IBD. Objective findings suggest that patients
miss ?42% of 6-MP/azathoprine and 50% of 5-ASA doses,
and that 81% and 93% of patients do not take at least
80% of 6-MP/azathoprine and 5-ASA doses, respectively.
The most commonly reported barriers to treatment adher-
ence were forgetting, interference by other activities, not
being at home, and difficulty swallowing pills. In contrast
to a recent study demonstrating the relationship between
barriers and subjective nonadherence (Ingerski et al.,
2009), results of this study revealed a significant correl-
ation between number of reported barriers and objective
nonadherence to 6-MP/azathioprine was observed, indicat-
ing that as the number of barriers to adherence increases,
so does nonadherence to 6-MP/azathioprine. This discrep-
ancy might suggest a unique difference in the barriers-
adherence relationship between the two study samples or
it might underscore the disparate sample sizes resulting
in contrasting findings. Nevertheless, this issue warrants
further empirical investigation. Overall, the results of this
study highlight the value added benefit of obtaining
both quantitative and qualitative data for assessment of
treatment adherence barriers as additional barriers might
Table II. Patient- and Parent-Reported Barriers on MAM Interview and Qualitative Interview
Barriers identified on MAM No. of times identified Barriers identified in qualitative interviewNo. of times identified
Interferes with activity
Hard to swallow pills
Don’t like the side effects
Don’t think it’s necessary
Not feeling well
Ran out/Didn’t fill (prescription)
Difficulty swallowing pills
Oppositional behavior in patient
Family or parent–child conflict about taking medications
Not allowing sufficient time for treatment
Do not plan ahead for treatment
Delayed medication effect
Hommel and Baldassano
not have been identified without the open-ended qualita-
tive interview used in this study.
From a clinical perspective, these data underscore the
importance of using patient history and clinical interview
data in a complementary manner with quantitative meas-
ures when assessing barriers to adherence. With respect
to intervention planning, there are several barrier targets
that would be appropriate for problem solving interven-
tions (e.g., interferes with activity, not being at home,
not planning ahead for treatment), behavioral treatment
(e.g., pill swallowing, oppositional behavior, parent–child
conflict), and medical team intervention (e.g., regimen
complexity, side effects). Further, although forgetting
was the most commonly reported barrier across quantita-
tive and qualitative assessments, clinical intervention
needs to address the underlying cause of forgetting, such
as managing unexpected events, change in routines, etc.
Moreover, it is likely critical to the success of any interven-
tion that the underlying cause of nonadherence, whether
accidental or volitional, be appropriately addressed.
The findings of this study should be considered within
the context of a few limitations. First, a modest sample size
was used. However, prior qualitative research has demon-
strated that data saturation can occur within 12 interviews
(Guest, Bunce, & Johnson, 2006). Indeed, data saturation
occurred within the first 10 interviews for this study.
Second, the sample was primary Caucasian and had
fairly high annual incomes. Although this is representative
of other studies in IBD (Hommel et al., 2008; Mackner &
Crandall, 2005a) and the IBD population overall, general-
ization of these findings to ethnic minorities or individuals
with lower annual incomes is not suggested. Third, this
represents a small scale mixed method study of adherence
barriers in pediatric IBD using a novel, combined quanti-
tative and qualitative methodology for assessment; thus,
findings should be viewed as preliminary and requiring
Future research should focus on replication of these
findings and further evaluation of the utility of this com-
bined quantitative and qualitative assessment approach.
Further, the results of this and future studies using this
methodology might inform continued refinement of assess-
ment measures to accurately identify additional barriers
to treatment adherence that patients and families are
experiencing. Moreover, inclusion of patients who repre-
sent lower socioeconomic status in future studies will
likely shed light on unique barriers experienced by this
subgroup of patients with IBD. Finally, this study identi-
fied potential targets for intervention that could be
included in testing of behavioral treatment protocols.
It will be important to examine the influence of particular
barriers on nonadherence and to determine the relative
impact on treatment outcome that results from targeting
various adherence barriers in this population.
Funding for this study was provided by National Institute
of Diabetes and Digestive and Kidney Diseases (K23
DK079037); Public Health Service (Grant P30 DK
Conflicts of interest: None declared.
Received September 24, 2009; revisions received November
16, 2009; accepted November 19, 2009
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