Responsiveness of the Work Productivity and Activity Impairment questionnaire for irritable bowel syndrome with constipation (WPAI:IBS-C) to clinically meaningful change Reilly MC,1 McBurney CR,2 Bracco A2 1Margaret Reilly Associates, Inc., New York, USA; 2Novartis Pharma AG, Basel, SwitzerlandABSTRACT BACKGROUND (cont’d) RESULTS (cont’d) RESULTS (cont’d) RESULTS (cont’d) Objective:
The work productivity and activity impairment measures of
The Work Productivity and Activity Impairment questionnaire for
● The responder rates for overall IBS symptom relief were 33.7%
● Responsiveness testing using WPAI:IBS-C measures of overall
Table 1. Baseline demographics of patients completing WPAI:IBS-C.
the Work Productivity and Activity Impairment questionnaire for irritable
IBS (WPAI:IBS) measures absenteeism, presenteeism, overall
and 24.2% in the tegaserod and placebo groups, respectively
IBS symptom relief and relief of abdominal discomfort/pain
bowel syndrome (WPAI:IBS) have been shown to discriminate among
work productivity loss (absenteeism plus presenteeism), and
Tegaserod Characteristic (n=1,363)
patients with different disease severity. The purpose of this investigation
daily activity impairment due to IBS symptoms during the
was to test the responsiveness of these measures to clinically
● The responder rates for relief of abdominal discomfort/pain were
meaningful changes in symptom severity among IBS patients with
The WPAI:IBS has been validated against three measures of IBS
31.3% and 22.1% in the tegaserod and placebo groups,
disease severity: retrospective diaries, a debriefing questionnaire,
Methods: Female patients (18–65 years old) who met Rome II criteria
and other self-report measures of work and activity impairment,3
for IBS, excluding those with frequent diarrhea, were assessed during a
but its sensitivity to detect clinically meaningful changes in IBS
● Responders for overall IBS symptom relief reported significantly
randomized, double-blind, placebo-controlled, multicenter study of
greater reductions in WPAI:IBS-C measures of presenteeism,
tegaserod 6 mg b.i.d. or placebo for 4 weeks. Absenteeism,
work productivity loss and daily activity impairment compared
presenteeism, overall work productivity loss, and activity impairment due
Responsiveness of WPAI:IBS-C to clinically
to IBS symptoms during the previous 7 days were measured with the
OBJECTIVE
with non-responders. Although a reduction in absenteeism score
meaningful change in IBS symptoms
WPAI:IBS-C, which excludes diarrhea as an IBS symptom. Patients were
● The aim of this study was to evaluate the responsiveness of the
was observed in responders compared with non-responders, the
classified as responders at Week 4 if they reported satisfactory relief of
● The sample sizes available for analyses of the various
WPAI:IBS, modified to exclude diarrhea as an IBS symptom
difference was not statistically significant (Figure 1)
abdominal discomfort/pain, or relief of overall IBS symptoms in at least
WPAI:IBS-C measures of responsiveness to overall IBS symptom
(WPAI:IBS–C), to clinically meaningful changes in IBS-C
3 of the 4 treatment weeks. The association between WPAI:IBS-C scores
relief, and relief of abdominal discomfort/pain, are shown in
and responder status was tested using a Cochran-Mantel-Haenszel test
Results:
A total of 2,660 women were randomized and of these 1,675
Table 2. Patients analyzed for WPAI:IBS-C responsiveness to overall
● Women (18–65 years of age) meeting Rome II criteria for IBS-C
T = tegaserod; P = placebo. Extended Cochran-Mantel-Haenszel tests were used to assess whether
(tegaserod [n=1,363], placebo [n=312]) were employed and completed
IBS symptom relief.
WPAI:IBS-C could discriminate between responders and non-responders
were randomized in a double-blind, placebo-controlled,
WPAI:IBS-C questionnaires. At Week 4, compared to non-responders,
Tegaserod
responders with relief in abdominal discomfort/pain reported significant
multicenter study of tegaserod 6 mg b.i.d. or placebo (ZENSAA:
Figure 2. Association between response for relief of abdominal
reductions in absenteeism (p=0.02), presenteeism (p<0.0001), overall
Zelnorm® in Europe, North and South America and Africa).4 The
Absenteeism discomfort/pain and WPAI:IBS-C scores.
work productivity loss (p<0.0001), and activity impairment (p<0.0001).
study comprised a 2-week treatment-free baseline period and
When overall IBS symptom relief was considered, compared with
two 4-week, double-blind treatment periods (P1, P2), separated
non-responders, responders reported significant reductions in all
Presenteeism
measures (p<0.0001), except absenteeism where the reduction was not
● Patients completed the WPAI:IBS-C at baseline and at Weeks 2
CONCLUSIONS Conclusion:
The WPAI:IBS-C work productivity and activity
Work productivity loss
● WPAI:IBS-C work productivity and daily activity impairment
● Patients were classified as responders at Week 4 of P1 if they
impairment measures are responsive to clinically meaningful change in
measures are responsive to clinically meaningful changes in
reported relief of overall IBS symptoms or satisfactory relief of
IBS symptom severity and are useful tools for measuring outcomes in
T = tegaserod; P = placebo. Extended Cochran-Mantel-Haenszel tests were used to assess whether
both overall IBS symptoms and abdominal discomfort/pain
abdominal discomfort/pain in at least 3 of the 4 treatment weeks
WPAI:IBS-C could discriminate between responders and non-responders
Daily activity impairment
● The WPAI:IBS-C, therefore, is a valid and responsive
● Extended Cochran-Mantel-Haenszel tests, stratified by treatment
measure to assess the effectiveness of IBS treatments on
group, were used to assess whether the WPAI:IBS-C could
Figure 1. Association between response for overall IBS symptom relief
overall work productivity and daily activities
discriminate between patients whose IBS symptoms clinically
and WPAI:IBS-C scores.
improved (responders) and patients whose IBS symptoms did not
BACKGROUND
improve (non-responders), regardless of treatment group
Table 3. Patients analyzed for WPAI:IBS-C responsiveness to relief
● Irritable bowel syndrome (IBS) is a chronic and episodic
of abdominal discomfort/pain.
Responders for relief of abdominal discomfort/pain reported
Analyses were based on the intent-to-treat (ITT) population who
gastrointestinal motility and sensory disorder characterized by
significantly greater reductions in each of the WPAI:IBS-C
Tegaserod REFERENCES
abdominal pain or discomfort, bloating and altered bowel habit
measures compared with non-responders (Figure 2)
(constipation, diarrhea, or alternating periods of both)
1. Gralnek IM, et al. Gastroenterology 2000;119:654–60. Absenteeism
IBS has a significant negative impact on patients’ quality of life by
● For both overall IBS symptom relief and relief of abdominal
2. American Gastroenterological Association. The Burden of
restricting their daily routines, social lives, personal relationships
Patient characteristics
Gastrointestinal Diseases. Bethesda, MD: American
Presenteeism
Gastroenterological Association, 2001. 1–86.
● A total of 2,660 women were randomized in P1; 2,135 received
– scores for WPAI:IBS-C measures for responders and
IBS symptoms can also have a detrimental effect on sufferers’
tegaserod and 525 received placebo. Of these patients, 1,363 in
non-responders improved (score decreased) during the study,
3. Reilly MC, et al. Aliment Pharmacol Ther 2004;20:459–67.
work productivity. The indirect costs associated with
the tegaserod group and 312 in the placebo group were
with the exception of absenteeism, which worsened (score
4. Tack J, et al. Gut (14 July, Epub ahead of print). Work productivity loss
absenteeism (missed days of work) and presenteeism (reduced
increased) for placebo non-responders (Figures 1 and 2)
on-the-job effectiveness) attributable to IBS are estimated to be
5. Müller-Lissner SA, et al. Aliment Pharmacol Ther 2001;15:1655–66.
● Baseline demographics of these subjects are shown in Table 1.
– the reductions in WPAI:IBS-C scores for all measures except
Patients in the tegaserod and placebo groups were comparable
absenteeism in the overall IBS symptom relief analysis
6. Novick J, et al. Aliment Pharmacol Ther 2002;16:1877–88. Daily activity impairment
● To assess the effectiveness of IBS treatment interventions on
for age and race; mean age was 40.8 years and the majority of
appeared greater in the tegaserod responders compared
reducing work productivity and daily activity impairments, valid
patients were Caucasian (approximately 86%) in both groups
with placebo responders, although this difference was not
This research was funded by Novartis Pharma AG, Basel, Switzerland.
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