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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, Switzerland ABSTRACT
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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