American Journal of Gastroenterology
C ?2005 by Am. Coll. of Gastroenterology
Published by Blackwell Publishing
Are Patients with Inflammatory Bowel Disease Receiving
Sarathchandra I. Reddy, M.D., Sonia Friedman, M.D., M.P.H., Jennifer J. Telford, M.D., Lisa Strate, M.D.,
Rie Ookubo, M.A., and Peter A. Banks, M.D.
Division of Gastroenterology, Crohn’s and Colitis Center, Brigham and Women’s Hospital,
Harvard Medical School, Boston, Massachusetts
OBJECTIVES:Guidelines have been published as a framework for therapy of patients with inflammatory bowel
disease (IBD). The purpose of this study was to determine whether patients referred for a second
opinion were receiving therapy in accordance with practice guidelines.
METHODS:Patients with luminal IBD under the care of a gastroenterologist who sought a a second opinion at
Brigham and Women’s Hospital between January 2001 and April 2003 were enrolled in this study.
Clinical information was obtained by direct patient interview at the time of initial patient visit and by
a review of prior records. Data obtained included the diagnosis, clinical symptoms, prior medical
therapy, preventive measures for metabolic bone disease, and colon-cancer screening.
RESULTS:The study population consisted of 67 consecutive patients: 21 with ulcerative colitis, 44 with
Crohn’s disease and 2 in whom the diagnosis of IBD could not be confirmed. Of the 65 patients with
confirmed IBD, 56 patients had symptoms of active disease and 9 were asymptomatic. All analyses
were carried out on the 56 patients with active disease. Of the 33 patients treated with
aminosalicylates, 21 (64%) were not receiving maximal doses. Nine of 12 (75%) patients with distal
ulcerative colitis were not receiving rectal aminosalicylate therapy. Within 6 months of their clinic
visit, 35 patients had received corticosteroid therapy, and 27 (77%) patients had been treated with
corticosteroids for greater than 3 months. In 16 of 27 (59%) there was no attempt to start steroid
sparing medications such as 6-mercaptopurine (6MP), azathioprine, or infliximab. Of the 11
patients treated with either 6MP or azathioprine, 9 (82%) were suboptimally dosed without an
attempt to increase dosage. Of the 27 patients on prolonged corticosteroid therapy 21 (78%)
received inadequate treatment to prevent metabolic bone disease. Three of 9 patients (33%)
meeting indications for surveillance colonoscopy for dysplasia had not undergone colonoscopy at
the appropriate interval.
CONCLUSIONS:Patients with IBD often do not receive optimal medical therapy. In particular, there is suboptimal
dosing of 5-ASA and immunomodulatory medications, prolonged use of corticosteroids, failure to
use steroid-sparing agents, inadequate measures to prevent metabolic bone disease, and
inadequate screening for colorectal cancer.
(Am J Gastroenterol 2005;100:1357–1361)
Practice guidelines have been developed which provide a
framework for the proper diagnosis, optimal medical man-
lines, it has been suggested that patients often do not receive
optimal treatment for IBD (3). To date, there have been no
of IBD. The aim of this study was to assess whether symp-
tomatic patients who were referred to our institution were
receiving optimal therapy for IBD in accordance with prac-
Consecutive patients under the direct care of gastroen-
terologists for IBD who presented for a second opinion
for management of IBD to Brigham and Women’s Hos-
pital, a tertiary care center, between January 2001 and
April 2003 were enrolled in the study. Patients who had
never consulted a gastroenterologist in the past or who
were now under the exclusive care of a nongastroenterol-
ogist were excluded. Patients with perianal or fistuliz-
ing disease in the absence of luminal disease were also
1358Reddy et al.
Figure 1. Severity scales adapted from practice guidelines for ul-
cerative colitis and Crohn’s disease (1, 2).
A retrospective review of patient records was conducted by
a single investigator (SIR). Clinical information that was ob-
tained from patient records included documentation of prior
of radiologic images and pathology if indicated. Data were
sic patient demographic information, information about ini-
tial diagnosis, duration of disease, and assessment of sever-
ity as outlined in the ACG practice guidelines (Fig. 1). Data
regarding medical therapy included use of oral and topical
5-ASA agents at the time of the clinic visit, corticosteroid
agents within the previous 6 months, and use of steroid spar-
ing agents including 6-mercaptopurine (6MP), azathioprine,
and infliximab. Preventive measures for metabolic bone dis-
sity scan were also recorded. In addition, colorectal cancer
surveillance was assessed.
Data were analyzed to assess for proportions of patients re-
tion of corticosteroid therapies. Proportions were expressed
as percents. Variables including age, sex, underlying dis-
ease, location, and disease duration were evaluated to de-
termine whether they predicted certain modes of treatment.
Chi-square test or Fisher’s exact test were used for the analy-
sis depending on sample size. All analysis was conducted at
5% two-sided level of significance.
A total of 67 consecutive patients referred for evaluation of
IBD were enrolled. The referral base consisted of 64 gas-
academic practices. The diagnosis of UC could be confirmed
Table 1. Distribution of Disease
Ulcerative colitis (21)
Crohn’s disease (44)
Small bowel involvement only
Colonic involvement only
Small bowel and colonic disease
Number of Patients
in 21 and Crohn’s disease in 44 patients. The median age was
35 yr (range 19–74). A total of 21 (31%) patients were male
and 46 (69%) were female. Two patients in whom a diagno-
sis of IBD could not be confirmed were excluded. In both of
supported the diagnosis of IBD.
Of the 65 patients with confirmed IBD, 56 (86%) were
symptomatic at the time of their clinical assessment. Sever-
ity of symptoms was classified as mild, moderate, or severe
according to criteria delineated in ACG practice guidelines
(1, 2) (Fig. 1). Based on these criteria, 32 of 56 (57%) of the
patient group had mild disease, 23 of 56 (41%) had moderate
disease, and 1 of 56 (2%) had severe disease. Information
regarding location of disease was present in 18 of 21 patients
the 56 symptomatic patients in the patient cohort.
The use of oral and topical 5-ASA agents was assessed.
Overall, 33 of 56 (59%) patients were receiving oral 5-ASA
therapy. A list of oral 5-ASA agents and proportion of pa-
tients receiving optimal dosing of these agents is detailed
in Table 2. Twenty-one of 33 (64%) of these patients had
not received optimal doses of these medications. There was
no significant difference in proportion of symptomatic pa-
tients with UC versus CD receiving suboptimal dosing of
oral 5-ASA agents (data not shown), Additional analysis re-
vealed that use of optimal 5-ASA dosing was not associated
with other variables such as sex, age, location of disease, and
not receiving oral 5-ASA agents, 7 patients (30%) had not
Table 2. 5-ASA Agents and Dosing
Patients(%) Suboptimally Dosed
Are Patients with IBD Receiving Optimal Care? 1359
Table 3. Prolonged Corticosteroid Therapy and Disease Severity
among Symptomatic Patients
This table illustrates the proportion of patients within disease severity groups who
were receiving prolonged steroid therapy (continuous steroid therapy for greater than
tolerated 5-ASA agents. Medical therapies used by the 23
symptomatic patients not receiving 5-ASA agents included
topical and oral corticosteroids, antibiotics, immunomodula-
tory agents, infliximab, and topical 5-ASA agents.
With regard to topical therapy among 12 symptomatic
patients with distal ulcerative colitis (defined as either
proctitis or left-sided colitis extending to the splenic flex-
ure), topical aminosalicylates were not used in 9 (75%)
Oral corticosteroid use within the prior 6 months was as-
corticosteroids within 6 months of their clinic visit. Twenty-
seven of 35 (77%) had received prolonged steroid therapy
defined as continuous steroid therapy for greater than a
3-month duration. There was no association between likeli-
time of clinical assessment was similar among patients with
mild disease and those with moderate or severe disease (mild
disease: median dose 20 mg/day, range 10–60 mg/day; mod-
steroid therapy, in 16 (59%) there was no attempt to start
steroid sparing medications such as 6MP, azathioprine, or
There were 11 patients receiving treatment with 6-MP or
azathioprine at the time of their clinic visit. Suboptimal dos-
ing was defined as a dose of 6-MP less than 1.0 mg/kg or
azathioprine less than 2.0 mg/kg in the absence of leukope-
nia (1, 2, 4). Using these criteria 9 of 11 (82%) received
suboptimal doses of these medications without an attempt to
increase dosage (6/8 with CD, 3/3 with UC). In all nine pa-
tients receiving suboptimal doses of these medications, there
was no prior history of leukopenia or other intolerance to
either 6-MP or azathioprine. Furthermore, in none of the 11
patients treated with 6-MP or azathioprine were TPMT en-
zyme activity or metabolite levels utilized to guide dosing
of these agents. A total of five symptomatic patients, all of
whom had Crohn’s disease, received treatment with inflix-
imab. Of the five symptomatic patients who had received
infliximab, four were on concomitant therapy with 6MP or
azathioprine, and one patient was receiving infliximab as
Table 4. Suboptimal Care in Inflammatory Bowel Disease
Clinical parameterProportion (%)
Suboptimal dosing of 5-ASA agents
Failure to use topical 5-ASA therapy
Treatment with corticosteroids
Failure to utilize steroid
Suboptimal dosing of
Inadequate preventive measures for
metabolic bone disease∗
Inadequate surveillance for
∗Among patients receiving steroid therapy for greater than 3 months.
Metabolic Bone Disease
Among the 27 patients receiving steroid therapy for greater
than 3 months, 21 (78%) patients had not received pharma-
cologic therapy for prevention of metabolic bone disease.
Preventive measures for patients on prolonged corticosteroid
therapy included calcium and vitamin D supplements, bis-
phosphonates, or hormone replacement therapy. Twenty of
Colorectal Cancer Screening
A total of 10 patients with ulcerative colitis or Crohn’s col-
itis had either left-sided or extensive colonic disease with
duration of disease for 8 yr or greater. Information regard-
ing colonoscopic surveillance was available in nine patients.
Three of nine (33%) patients meeting indications for bian-
nual colonoscopy had not undergone colonoscopy within the
appropriate interval. There were no differences between pa-
tients with Crohn’s disease and those with ulcerative colitis
with regard to the likelihood that they had undergone screen-
ing colonoscopy at appropriate intervals.
A summary of the major findings which illustrate subop-
timal care of patients with IBD is presented in Table 4.
and have not changed significantly (1, 2, 4–6). Thus far, no
studies have assessed whether patients with IBD receive care
in accordance with practice guidelines. We found that the
management of IBD is often suboptimal as evidenced by
underdosing of maintenance medications, prolonged use of
equate attention to metabolic bone disease and screening for
Multiple studies and reviews on medical therapy for IBD
suggest that the therapeutic benefits of 5-ASA agents are
1360Reddy et al.
is more convincing for ulcerative colitis than for Crohn’s dis-
ease, higher doses of pentasa may be required to achieve
remission in patients with Crohn’s disease (12). In our study,
greater than 60% of symptomatic patients were not receiving
the optimal dose of aminosalicylates although these patients
were tolerating lower doses of these medications.
found that 75% of symptomatic patients with distal disease
were not receiving topical 5-ASA agents.
Perhaps the most striking finding in this study pertains
to the use of corticosteroids. While studies have shown that
in both Crohn’s disease and ulcerative colitis, controlled tri-
als have shown that steroids are ineffective as maintenance
therapy for Crohn’s disease and ulcerative colitis (7, 15–17).
among our patient cohort. In the preceding 6 months, more
than 75% of the patients who been treated with steroids had
tients receiving prolonged steroid therapy had mild disease,
and the median dose of prednisone did not differ between
patients with mild versus moderate to severe disease. While
there may be many reasons for the continuation of steroid
therapy, these findings suggest that corticosteroids were of-
ten used for excessive duration even in patients with mild
disease without a clear “exit” strategy utilizing alternative
agents for induction of remission.
biologics such as infliximab provide one possible exit strat-
Immunomodulatory therapy with 6MP or azathioprine is ef-
fective in both ulcerative colitis and Crohn’s disease for the
tients who had received prolonged steroid therapy, we found
that approximately 60% had not been started on therapy with
azathioprine or 6-MP as steroid-sparing agents.
underdosed in greater than 80% of patients. While dosing of
these agents could be limited by leukopenia or liver function
or abnormal liver function tests either in the past or at the
in determining the optimal dose of 6-MP and azathioprine.
ceiving prolonged corticosteroid therapy or those with long-
standing disease are at greater risk of metabolic bone disease
(20, 21). Bone loss is most rapid in the first few weeks to
months of steroid therapy (21). While our study did not ex-
amine the full range of detrimental corticosteroid induced
side effects, we did examine whether adequate pharmaco-
logic measures had been undertaken for the prevention of
metabolic bone disease. We determined that 78% of patients
who had received steroid therapy for greater than 3 months
had not received any medical therapies to prevent metabolic
bone disease and had not undergone bone mineral density
ing ulcerative colitis and Crohn’s colitis and have established
screening guidelines for patients with ulcerative colitis and
Crohn’s colitis (1, 22). In our patient group, one-third of the
of disease for at least 8 yr had not undergone colonoscopy
within 2 yr of their clinical assessment.
There are several potential limitations of this study, which
reflect the specific practice patterns of our referral base and
troenterologists caring for patients with IBD. Furthermore,
as it was focused on ambulatory patients who had predomi-
nantly mild or moderate disease, our study did not examine
the quality of care of patients with severe disease who may
have been admitted directly to a hospital.
patient compliance, which encompasses multiple behaviors
that can impact on medical care. Patient compliance includes
adherence to the treatment plan as outlined by the gastroen-
terologist. Our study did not examine possible discrepancies
between the doses of medications, which were prescribed by
cent ulcerative colitis (23). Patient compliance also includes
adherence to scheduled appointments. Missed appointments
may represent a lost opportunity for the gastroenterologist
to modify the treatment plan. Patient compliance with medi-
cal therapy and appropriate clinical follow-up are important
variables that impact on the quality of care of patients with
Finally, this study did not focus on factors relating to the
expertise of physicians, such as number of years in practice,
general experience in IBD, or impact of continuing medical
education in IBD. In this regard, the introduction of practice
guidelines for IBD in a tertiary care center has been shown
in one report to reduce practice variation and result in an
improved quality of care for patients (24).
In summary, our study found that symptomatic patients
in our cohort were often being treated with suboptimal
doses of maintenance medications including 5-ASA and im-
munomodulatory agents. Furthermore, patients were often
treated with corticosteroids for prolonged periods without an
attempt to employ steroid sparing agents. Finally, there were
inadequate measures to prevent metabolic bone disease and
Are Patients with IBD Receiving Optimal Care? 1361
by gastroenterologists, and patient tolerance of various ther-
apies are all factors that influence the care of patients with
IBD. Larger prospective studies will help to elucidate the
most important factors that influence the quality of care of
patients with IBD.
Reprint requests and correspondence: Sarathchandra I. Reddy,
M.D., M.P.H., Division of Gastroenterology, Brigham and Women’s
Hospital, 75 Francis Street, Boston, MA 02115.
Received May 25, 2004; accepted November 16, 2004.
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