1
RESULTS (cont’d) ABSTRACT Introduction: Irritable bowel syndrome with constipation (IBS-C) is a chronic and episodic gastrointestinal motility and sensory disorder characterized by abdominal pain or discomfort associated with constipation Aims and methods: The objective of this study was to assess healthcare utilization, productivity loss and quality of life (QoL) in subjects with IBS-C compared with subjects without IBS-C in France (FR), Germany (DE) and the United Kingdom (UK). The study population consisted of respondents to the 2004 National Health and Wellness Survey (NHWS). This survey is an annual cross-sectional survey of a nationally representative sample of the adult population (18 years) that covers a broad range of health topics. Eligible respondents from FR, DE and UK completed a questionnaire on the internet regarding symptom burden and healthcare utilization, the general health version of the Work Productivity and Activity Impairment questionnaire (WPAI:GH), and the 8-item Short-Form Health Survey (SF-8) QoL questionnaire. A multivariate analysis was performed controlling for age, gender and number of physical comorbidities Results: Of the 26,468 respondents, 2,696 (10.2%) reported being diagnosed with IBS-C or having IBS-C symptoms (abdominal pain, bloating and constipation). 70% of subjects were female. The mean age was 42.1 years. The IBS-C population in the three countries had greater healthcare utilization: 8.4 physician visits per subject in the previous 6 months versus 5 visits, and 0.3 emergency room visits versus 0.1 visits for the non-IBS-C population. Subjects with IBS-C reported 1.4 mean hospital days during the past 6 months, versus 0.7 days. All the differences were statistically significant (p values <0.005). 12,862 respondents completed the WPAI:GH: 1,168 with IBS-C and 11,694 without IBS-C. Subjects with IBS-C reported 9% work time missed (absenteeism) versus 4.6% in the non-IBS-C population. Impairment at work (presenteeism) was 25.3% and 12.7%, respectively, for subjects with IBS-C and without IBS-C. The overall work productivity loss was greater for those with IBS-C than for those without IBS-C (27.2% vs 13.5%). Impairment in performing daily activities was also higher for IBS-C subjects than for subjects without IBS-C (38.9% vs 21.3%). Patients with IBS-C reported a significantly poorer QoL compared with patients without the disease. The SF-8 mental and physical component summary scores were 42.2 and 44.4, respectively, for the IBS-C population compared with 49.4 and 49.4, respectively, for the non-IBS-C subjects Conclusions: In FR, DE and the UK, patients with IBS-C had significantly greater utilization of healthcare resources, experienced higher work productivity loss and activity impairment, and had significantly worse QoL than those patients without IBS-C Burden of irritable bowel syndrome with constipation on healthcare resource utilization, work productivity, activity impairment and quality of life in France, Germany and the United Kingdom Bracco A, 1 Reilly MC, 2 McBurney CR, 1 Ambegaonkar B 3 1 Novartis Pharma AG, Basel, Switzerland, 2 Margaret Reilly Associates, Inc., New York; 3 Consumer Health Sciences, Princeton, USA CONCLUSIONS This analysis of the 2004 NHWS data from France, Germany and the United Kingdom revealed that: IBS-C subjects had a greater utilization of healthcare resources in terms of physician and emergency room visits, as well as hospitalization than the non-IBS-C subjects productivity loss and activity impairment were higher in people with IBS-C compared with people without the disorder subjects with IBS-C reported a lower QoL than the non-IBS-C population Effective treatments for IBS may improve sufferers’ QoL and reduce the substantial impact placed on healthcare resources BACKGROUND Irritable bowel syndrome with constipation (IBS-C) is a chronic and episodic gastrointestinal motility and sensory disorder characterized by recurrent abdominal pain/discomfort, bloating and constipation IBS occurs in 10–15% of the global population 1–4 IBS has been shown to have a substantial economic impact resulting from the direct consumption of healthcare resources, loss of productivity, and reduction in quality of life (QoL) 5–7 AIMS This study investigated healthcare utilization, loss of productivity, and QoL in subjects with IBS-C compared with subjects without IBS-C in France, Germany and the United Kingdom METHODS Study sampling and data collection The study population consisted of respondents from the 2004 National Health and Wellness Survey (NHWS) The NHWS is an annual cross-sectional survey of attitudes, behaviors and treatment choices related to healthcare Data were collected through self-administered internet- based questionnaires in 2004 from a nationally representative sample of community-based adults in France, Germany and the United Kingdom Inclusion criteria Men and women at least 18 years of age were included in the analysis Patients diagnosed with IBS-C or experiencing IBS-C with symptoms (abdominal pain, bloating and constipation) were included in the IBS-C population The non-IBS-C population comprised the rest of the respondents Table 1. Demographics and health characteristics. Demographic or Total IBS-C Non-IBS-C health characteristic (n=26,468) (n=2,696) (n=23,772) Mean age (years) 44.8 42.1* 45.1 Female (%) 48.0 70.0* 45.0 One or more physical comorbidities 63.0 77.0* 61.0 *p<0.001 vs non-IBS-C Table 2. SF-8 HR QoL measures. IBS-C Non-IBS-C Summary score subjects subjects Mental component Mean 42.2* 49.4 – summary score Range 11–67 7–71 SD 11.84 9.87 Physical component Mean 44.4* 49.4 – summary score Range 11–68 9–69 SD 11.42 9.69 SD = standard deviation; *p<0.001 This research was funded by Novartis Pharma AG, Basel, Switzerland. Poster presented at UEGW 2005. REFERENCES 1. Badia X, et al. Pharmacoeconomics. 2002;20:749–58. 2. Camilleri M, Choi MG. Aliment Pharmacol Ther 1997;11:3–15. 3. Talley NJ. Am J Gastroenterol 2003;98:750–8. 4. Hungin AP, et al. Aliment Pharmacol Ther 2003;17:643–50. 5. Longstreth GF, et al. Am J Gastroenterol 2003; 98:600–7. 6. Akehurst RL, et al. Pharmacoeconomics 2002;20:455–62. 7. Inadomi MJ, et al. Aliment Pharmacol Ther 2003;18:671–82. 8. Reilly MC, et al. Pharmacoeconomics 1993;4:353–65. 9. Ware JE, et al. Manual for users of the SF-8 Health Survey. Lincoln, Rhode Island: QualityMetric Incorporated, 2001. 8.4* 0.3* 1.4* IBS-C subjects Non-IBS-C subjects 10 8 6 4 2 0 Mean number of visits or days 5.0 0.1 0.7 Physician visits Emergency room visits Days hospitalized Figure 1. Healthcare utilization in the previous 6 months. 9.0* 25.3* 27.2* 38.9* 4.6 12.7 13.5 21.3 IBS-C subjects Non-IBS-C subjects 40 30 20 10 0 Impairment (%) Absenteeism Presenteeism Overall work productivity loss Daily activity impairment Figure 2. Work productivity and daily activity impairment. METHODS (cont’d) Outcomes measured Healthcare utilization Emergency room visits, number of days hospitalized, and visits to physicians in the past 6 months were used to measure healthcare resource use The total number of physician visits was calculated as the sum of visits to all physicians listed in the questionnaire, including general/family doctors, cardiologists, diabetologists, dentists, endocrinologists, gastroenterologists, gynecologists, neurologists, and psychiatrists Productivity loss and activity impairment The Work Productivity and Activity Impairment questionnaire, General Health version (WPAI:GH) assessed work time missed, and work and activity impairment due to health problems in the past 7 days 8 Health-related quality of life (HRQoL) HRQoL during the month preceding the questionnaire was assessed using the Medical Outcomes Study 8-item Short-Form Health Survey (SF-8) 9 The SF-8 is a generic HRQoL measure designed to assess physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health 9 Statistical analysis A multivariate analysis (ANCOVA) was performed controlling for age, gender, and number of physical comorbidities such as GERD/heartburn, arthritis, and psoriasis RESULTS Patient demographics Of the 26,468 respondents, 10.2% (n=2,696) reported being diagnosed with IBS-C or having IBS-C symptoms of abdominal pain, bloating and constipation (Table 1) Women comprised 70% of the IBS-C population compared with 45% in the non-IBS-C group The non-IBS-C subjects were older (mean age of 45.1 years) than those with IBS-C (mean age of 42.1 years) 77% of the IBS-C population had more than one physical comorbidity compared with 61% for the non-IBS-C population All differences were statistically significant (p<0.001) Healthcare resource utilization The impact of IBS-C on healthcare resource utilization in the previous 6 months is shown in Figure 1 IBS-C subjects reported an average of 8.4 physician visits vs 5.0 visits for the non-IBS-C population The IBS-C population visited the emergency room three times more on average than the non-IBS-C population (0.3 vs 0.1 visits, respectively) Subjects with IBS-C reported on average twice as many hospitalized days than the non-IBS-C subjects (1.4 days vs 0.7 days, respectively) All differences were statistically significant (p<0.001) Work productivity and daily activities The impact of IBS on work productivity and daily activity impairment in the previous 7 days is shown in Figure 2 A total of 12,862 respondents completed the WPAI:GH; of these, 1,168 respondents were in the IBS-C group and 11,694 were in the non-IBS-C group Subjects with IBS-C reported 9% work time missed (absenteeism) vs 4.6% in the non-IBS-C subjects. Impairment at work (presenteeism) was 25.3% and 12.7%, respectively, for subjects with and without IBS-C The overall work productivity loss (absenteeism plus presenteeism) was greater for subjects with IBS-C than for those without IBS-C (27.2% vs 13.5%) Impairment in performing daily activity was 38.9% vs 21.3%, respectively, for IBS-C and non-IBS-C subjects All differences were statistically significant (p<0.001) Health-related quality of life (HRQoL) The impact of IBS on HRQoL measures is shown in Table 2 The mental and physical component summary scores of SF-8 were 42.2 and 44.4, respectively, for the IBS-C subjects vs 49.4 and 49.4, respectively, for the non-IBS-C subjects All differences were statistically significant (p<0.001) ANCOVA results The results, controlled for age, gender, and number of physical comorbidities, indicated that the IBS-C population had significantly lower physical and mental component scores, significantly higher work and daily activity impairment, and significantly higher utilization of healthcare resources than the non-IBS-C population (p<0.001)

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Page 1: Burden of irritable bowel syndrome with constipation … · Irritable bowel syndrome with constipation ... IBS-C Non-IBS-C Summary score subjects subjects ... et al. Manual for users

RESULTS (cont’d)ABSTRACTIntroduction: Irritable bowel syndrome with constipation (IBS-C)is a chronic and episodic gastrointestinal motility and sensorydisorder characterized by abdominal pain or discomfortassociated with constipation

Aims and methods: The objective of this study was to assesshealthcare utilization, productivity loss and quality of life (QoL) insubjects with IBS-C compared with subjects without IBS-C inFrance (FR), Germany (DE) and the United Kingdom (UK). Thestudy population consisted of respondents to the 2004 NationalHealth and Wellness Survey (NHWS). This survey is an annualcross-sectional survey of a nationally representative sample of theadult population (≥18 years) that covers a broad range of healthtopics. Eligible respondents from FR, DE and UK completed aquestionnaire on the internet regarding symptom burden andhealthcare utilization, the general health version of the WorkProductivity and Activity Impairment questionnaire (WPAI:GH), andthe 8-item Short-Form Health Survey (SF-8) QoL questionnaire.A multivariate analysis was performed controlling for age, genderand number of physical comorbidities

Results: Of the 26,468 respondents, 2,696 (10.2%) reported beingdiagnosed with IBS-C or having IBS-C symptoms (abdominal pain,bloating and constipation). 70% of subjects were female. Themean age was 42.1 years. The IBS-C population in the threecountries had greater healthcare utilization: 8.4 physician visits per subject in the previous 6 months versus 5 visits, and0.3 emergency room visits versus 0.1 visits for the non-IBS-Cpopulation. Subjects with IBS-C reported 1.4 mean hospital daysduring the past 6 months, versus 0.7 days. All the differences werestatistically significant (p values <0.005). 12,862 respondentscompleted the WPAI:GH: 1,168 with IBS-C and 11,694 withoutIBS-C. Subjects with IBS-C reported 9% work time missed(absenteeism) versus 4.6% in the non-IBS-C population.Impairment at work (presenteeism) was 25.3% and 12.7%,respectively, for subjects with IBS-C and without IBS-C. Theoverall work productivity loss was greater for those with IBS-Cthan for those without IBS-C (27.2% vs 13.5%). Impairment inperforming daily activities was also higher for IBS-C subjects thanfor subjects without IBS-C (38.9% vs 21.3%). Patients with IBS-Creported a significantly poorer QoL compared with patientswithout the disease. The SF-8 mental and physical componentsummary scores were 42.2 and 44.4, respectively, for the IBS-Cpopulation compared with 49.4 and 49.4, respectively, for thenon-IBS-C subjects

Conclusions: In FR, DE and the UK, patients with IBS-C hadsignificantly greater utilization of healthcare resources, experiencedhigher work productivity loss and activity impairment, and hadsignificantly worse QoL than those patients without IBS-C

Burden of irritable bowel syndrome with constipationon healthcare resource utilization, work productivity,

activity impairment and quality of life in France,Germany and the United Kingdom

Bracco A,1 Reilly MC,2 McBurney CR,1 Ambegaonkar B3

1Novartis Pharma AG, Basel, Switzerland, 2Margaret Reilly Associates, Inc., New York; 3Consumer Health Sciences, Princeton, USA

CONCLUSIONS� This analysis of the 2004 NHWS data from France,

Germany and the United Kingdom revealed that:– IBS-C subjects had a greater utilization of healthcare

resources in terms of physician and emergency room visits, as well as hospitalization than the non-IBS-C subjects

– productivity loss and activity impairment were higherin people with IBS-C compared with people withoutthe disorder

– subjects with IBS-C reported a lower QoL than thenon-IBS-C population

� Effective treatments for IBS may improve sufferers’QoL and reduce the substantial impact placed onhealthcare resources

BACKGROUND� Irritable bowel syndrome with constipation (IBS-C) is a

chronic and episodic gastrointestinal motility and sensorydisorder characterized by recurrent abdominalpain/discomfort, bloating and constipation

� IBS occurs in 10–15% of the global population1–4

� IBS has been shown to have a substantial economicimpact resulting from the direct consumption of healthcareresources, loss of productivity, and reduction in quality oflife (QoL)5–7

AIMS� This study investigated healthcare utilization, loss of

productivity, and QoL in subjects with IBS-C comparedwith subjects without IBS-C in France, Germany and theUnited Kingdom

METHODSStudy sampling and data collection� The study population consisted of respondents from the

2004 National Health and Wellness Survey (NHWS)� The NHWS is an annual cross-sectional survey of attitudes,

behaviors and treatment choices related to healthcare� Data were collected through self-administered internet-

based questionnaires in 2004 from a nationally representativesample of community-based adults in France, Germany andthe United Kingdom

Inclusion criteria � Men and women at least 18 years of age were included in

the analysis� Patients diagnosed with IBS-C or experiencing IBS-C with

symptoms (abdominal pain, bloating and constipation) wereincluded in the IBS-C population

� The non-IBS-C population comprised the rest of therespondents

Table 1. Demographics and health characteristics.

Demographic or Total IBS-C Non-IBS-Chealth characteristic (n=26,468) (n=2,696) (n=23,772)

Mean age (years) 44.8 42.1* 45.1

Female (%) 48.0 70.0* 45.0

One or morephysical comorbidities 63.0 77.0* 61.0

*p<0.001 vs non-IBS-C Table 2. SF-8 HR QoL measures.

IBS-C Non-IBS-CSummary score subjects subjects

Mental component Mean 42.2* 49.4– summary score Range 11–67 7–71

SD 11.84 9.87

Physical component Mean 44.4* 49.4– summary score Range 11–68 9–69

SD 11.42 9.69

SD = standard deviation; *p<0.001

This research was funded by Novartis Pharma AG, Basel, Switzerland.Poster presented at UEGW 2005.

REFERENCES1. Badia X, et al. Pharmacoeconomics. 2002;20:749–58. 2. Camilleri M, Choi MG. Aliment Pharmacol Ther 1997;11:3–15. 3. Talley NJ. Am J Gastroenterol 2003;98:750–8.4. Hungin AP, et al. Aliment Pharmacol Ther 2003;17:643–50.5. Longstreth GF, et al. Am J Gastroenterol 2003; 98:600–7.6. Akehurst RL, et al. Pharmacoeconomics 2002;20:455–62.7. Inadomi MJ, et al. Aliment Pharmacol Ther 2003;18:671–82.8. Reilly MC, et al. Pharmacoeconomics 1993;4:353–65.9. Ware JE, et al. Manual for users of the SF-8 Health Survey. Lincoln, Rhode Island: QualityMetric

Incorporated, 2001.

8.4*

0.3*1.4*

IBS-C subjects Non-IBS-C subjects

10

8

6

4

2

0

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mb

er o

fvi

sits

or

day

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Physician visitsEmergency room visitsDays hospitalized

Figure 1. Healthcare utilization in the previous 6 months.

9.0*

25.3*27.2*

38.9*

4.6

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21.3

IBS-C subjects Non-IBS-C subjects

40

30

20

10

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Imp

airm

ent

(%)

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AbsenteeismPresenteeismOverall work productivity lossDaily activity impairment

Figure 2. Work productivity and daily activity impairment.

METHODS (cont’d)Outcomes measuredHealthcare utilization� Emergency room visits, number of days hospitalized, and

visits to physicians in the past 6 months were used tomeasure healthcare resource use

� The total number of physician visits was calculated as thesum of visits to all physicians listed in the questionnaire,including general/family doctors, cardiologists, diabetologists,dentists, endocrinologists, gastroenterologists, gynecologists,neurologists, and psychiatrists

Productivity loss and activity impairment � The Work Productivity and Activity Impairment

questionnaire, General Health version (WPAI:GH) assessedwork time missed, and work and activity impairment due tohealth problems in the past 7 days8

Health-related quality of life (HRQoL)� HRQoL during the month preceding the questionnaire was

assessed using the Medical Outcomes Study 8-itemShort-Form Health Survey (SF-8)9

� The SF-8 is a generic HRQoL measure designed to assessphysical functioning, role limitations due to physical healthproblems, bodily pain, general health, vitality, socialfunctioning, role limitations due to emotional problems,and mental health9

Statistical analysis� A multivariate analysis (ANCOVA) was performed controlling

for age, gender, and number of physical comorbidities suchas GERD/heartburn, arthritis, and psoriasis

RESULTSPatient demographics� Of the 26,468 respondents, 10.2% (n=2,696) reported being

diagnosed with IBS-C or having IBS-C symptoms ofabdominal pain, bloating and constipation (Table 1)

� Women comprised 70% of the IBS-C population comparedwith 45% in the non-IBS-C group

� The non-IBS-C subjects were older (mean age of45.1 years) than those with IBS-C (mean age of 42.1 years)

� 77% of the IBS-C population had more than one physicalcomorbidity compared with 61% for the non-IBS-Cpopulation

� All differences were statistically significant (p<0.001)

Healthcare resource utilization� The impact of IBS-C on healthcare resource utilization in

the previous 6 months is shown in Figure 1� IBS-C subjects reported an average of 8.4 physician visits

vs 5.0 visits for the non-IBS-C population� The IBS-C population visited the emergency room three

times more on average than the non-IBS-C population(0.3 vs 0.1 visits, respectively)

� Subjects with IBS-C reported on average twice as manyhospitalized days than the non-IBS-C subjects (1.4 daysvs 0.7 days, respectively)

� All differences were statistically significant (p<0.001)

Work productivity and daily activities � The impact of IBS on work productivity and daily activity

impairment in the previous 7 days is shown in Figure 2

� A total of 12,862 respondents completed the WPAI:GH; ofthese, 1,168 respondents were in the IBS-C group and11,694 were in the non-IBS-C group

� Subjects with IBS-C reported 9% work time missed(absenteeism) vs 4.6% in the non-IBS-C subjects.Impairment at work (presenteeism) was 25.3% and 12.7%,respectively, for subjects with and without IBS-C

� The overall work productivity loss (absenteeism pluspresenteeism) was greater for subjects with IBS-C than forthose without IBS-C (27.2% vs 13.5%)

� Impairment in performing daily activity was 38.9% vs21.3%, respectively, for IBS-C and non-IBS-C subjects

� All differences were statistically significant (p<0.001)

Health-related quality of life (HRQoL)� The impact of IBS on HRQoL measures is shown in Table 2� The mental and physical component summary scores of

SF-8 were 42.2 and 44.4, respectively, for the IBS-Csubjects vs 49.4 and 49.4, respectively, for the non-IBS-Csubjects

� All differences were statistically significant (p<0.001)

ANCOVA results� The results, controlled for age, gender, and number of

physical comorbidities, indicated that the IBS-C populationhad significantly lower physical and mental componentscores, significantly higher work and daily activityimpairment, and significantly higher utilization of healthcareresources than the non-IBS-C population (p<0.001)