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Prevalence and health-related quality of life (HRQOL) associated with irritable bowel syndrome in a community sample
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Abstracts
AJG – Vol. 95, No. 9, 2000
(n⫽5388 visits). IndC complications were compared to 132 patients with UC by retrospective chart review. Results: The incidence of pouchitis, perineal fistula/abscess formation, anastomotic complications, or proven Crohns disease was not significantly different between UC and IndC patients. Pouch loss (pouch excision, or a non-functioning, proximally-diverted pouch) did not increase significantly. Pelvic abscess formation increased from 1.2% (UC) to 8.7% (Ind; p⬍0.01). Nighttime stool frequency was increased from 1 (0 –2) to 2 (1–2) in IndC (p⬍0.001). There was no significant difference in quality of life, health, energy or happiness. Patients were equally happy to recommend surgery to IndC or UC patients, but 3% fewer IndC would undergo the same surgery if required for their disease. Conclusions: Complication rates are equivalent after IPAA for IndC and UC, with a similar functional outcome and quality of life after surgery. Over 93% of IndC patients would undergo the same procedure again, and 98% would recommend IPAA to others with IndC. Patients with IndC should not be precluded from having IPAA surgery. Total Fully Surgery BM continent again Ind 7 (5–10) 70.3% (n⫽115) UC (n⫽1399) 7 (5–9) 73.7% Median (IQR)
93.3%
Q. of life
Q. of Level of Level of health energy happiness
9 (8–10) 8 (7–10) 8 (6–9) 10 (8–10)
96.5%* 9 (8–10) 9 (8–10) 8 (7–9) 10 (9–10) *p⬍0.05, Chi squared test
HMO. Participants completed a telephone survey administered by trained personnel, blinded to the study intent, which included demographics, the Rome I criteria, SF-36, Psychosomatic checklist, the Novartis IBS-QOL instrument (for respondents meeting Rome I criteria), and other burden of illness items. Patient records from the health plan provided diagnoses from any inpatient or outpatient visits for the year of the survey. Respondents who did and did not meet the Rome I criteria were compared with respect to demographic and HRQOL variables using Fisher’s Exact and Wilcoxon rank-sums tests. Effect sizes were expressed as standardized mean differences (d). Results: Of the 2354 people contacted, 1032 (44%) agreed to participate. A total of 94 (9%) were classified as having IBS by Rome I criteria. All demographic variables including age, gender, race, marital status, education and income were comparable between IBS and non-IBS respondents. The sample was 60% female, 40% Hispanic, and the mean age was 39.73 (SD⫽9.84). Only 4 (0.5%) and 1 (1.2%) of the non-IBS and IBS participants, respectively, received a diagnosis of IBS while under medical care during the last year. Respondents with IBS had significantly (p⬍.0001) lower scores on all 8 subscales and the Physical and Mental Health Summary Scores of the SF-36 compared to respondents not suffering from IBS (d’s range .44 – .86). The Psychosomatic Checklist scores were significantly (p⬍.0001) higher for IBS than non-IBS respondents (d⫽.75), indicating more frequent and severe somatic complaints. Conclusion: Despite the fact that almost no one in the sample was diagnosed with IBS by a physician during the past year, 9% of the sample met the Rome I criteria for IBS. Based on measures of generic and diseasespecific HRQOL, these respondents experienced significant disease burden.
746 Lack of utility of risk factors in predicting symptomatic ulcers and ulcer complications on non-steroidal anti-inflammatory drugs (NSAIDs) Eisen G. on behalf of the CLASS investigators. Vanderbilt University Medical Center, Department of Medicine, Nashville, TN 37232-2279, United States; and Clinical Research and Development, G.D. Searle, Skokie, IL 60077. Data from the CLASS study were analyzed to identify patients at risk for NSAID-related symptomatic ulcers and ulcer complications. Univariate and multivariate analysis of potential risk factors for symptomatic ulcers and ulcer complications was performed in patients on conventional NSAIDs. Univariate analysis identified the following as significant risk factors for NSAID-associated symptomatic ulcers and ulcer complications (relative risk): age ⱖ 75 y (3.7), history of ulcer disease (2.7), history of GI bleeding (3.4), aspirin use (2.3), cardiovascular disease (1.6), and H. pylori ??positivity (2.0). Multivariate analysis identified age ⱖ 75 y, history of ulcer disease, and aspirin use as the most important risk factors (relative risk of 3.3, 2.6, and 2.1, respectively). Patients on celecoxib were most at risk if they were on concurrent low-dose aspirin. This study confirms the NSAID risk factor analysis of the MUCOSA trial and that risk increases non-additively with the number of risk factors. However, most events in patients treated with conventional NSAIDs occur in patients at low or no risk. Sponsored by GD Searle & Co.
747 Prevalence and health-related quality of life (HRQOL) associated with irritable bowel syndrome in a community sample Eisen GM, Weinfurt KP*, Hurley J⫹, Zacker C#, Coombs L*, Maher S*, Schulman KA.* Vanderbilt University Medical Center, Duke University Medical Center*, Novartis Pharmaceuticals#, Southwest Center for Managed Care Research, Lovelace Respiratory Research Institute⫹. Purpose: To determine the prevalence and HRQOL of Irritable Bowel Syndrome (IBS) in a managed care organization in the US Methods: A cross-sectional/case-control study was performed on a random sample of the 1998 and 1999 enrollment files of the Lovelace health plan
748 The economic burden of irritable bowel syndrome in a managed care organization Eisen GM, Weinfurt KP*, Hurley J⫹, Zacker C#, Coombs L*, Maher S*, Schulman KA.* Vanderbilt University Medical Center, Duke University Medical Center*, Novartis Pharmaceuticals#, Southwest Center for Managed Care Research, Lovelace Respiratory Research Institute⫹. Background: The costs of IBS for the US have been estimated at 4 – 8 billion dollars/year. Widely varying estimates may be due to limited access to all sources of direct medical expenditures. Aim: To determine the economic burden of IBS in a managed care setting where all direct expenditures, including inpatient/outpatient care and pharmaceutical use, are captured. Methods: A cross-sectional/case-control study was performed on a random sample of the 1998 and 1999 enrollment files of the Lovelace health plan HMO. This methodology captured individuals in the health plan regardless if they had sought health care in the previous year. Cases were determined by the Rome I criteria. Outpatient/inpatient charges and pharmaceutical charges for the previous 12 months were obtained for all individuals completing the telephone survey using the SCMCR Managed Care Database. All charges were expressed in 1999 dollars. Resource utilization and costs were compared between groups using bootstrapped 95% confidence intervals. Results: Of the 2354 people contacted, 1032 (44%) agreed to participate. A total of 94 (9%) were classified as having IBS by Rome I criteria. All demographic variables including age, gender, race, marital status, education and income were comparable between IBS and non-IBS respondents. The sample was 60% female, 40% Hispanic, and the mean age was 39.73 (SD⫽9.84). Respondents with IBS had a greater mean number of outpatient visits in the preceding year compared to non-IBS respondents (9.10 vs. 6.85; 95% C.I., 0.3 – 5.2). Respondents with and without IBS did not differ in the number of hospitalizations. Compared to all other respondents, those with IBS used more medications per year on average (5.9 vs. 4.8; 95% C.I. .06 – 2.32). There was a trend toward increased charges for both outpatient visits (median $934 vs. $680; 95% C.I. $⫺32.45 – $514.93) and prescription charges (median $285 vs. $241; 95% C.I. $⫺50.48 – $226.11) for IBS respondents compared to non-IBS respondents. Inpatient charges did not
Abstracts
AJG – Vol. 95, No. 9, 2000
(n⫽5388 visits). IndC complications were compared to 132 patients with UC by retrospective chart review. Results: The incidence of pouchitis, perineal fistula/abscess formation, anastomotic complications, or proven Crohns disease was not significantly different between UC and IndC patients. Pouch loss (pouch excision, or a non-functioning, proximally-diverted pouch) did not increase significantly. Pelvic abscess formation increased from 1.2% (UC) to 8.7% (Ind; p⬍0.01). Nighttime stool frequency was increased from 1 (0 –2) to 2 (1–2) in IndC (p⬍0.001). There was no significant difference in quality of life, health, energy or happiness. Patients were equally happy to recommend surgery to IndC or UC patients, but 3% fewer IndC would undergo the same surgery if required for their disease. Conclusions: Complication rates are equivalent after IPAA for IndC and UC, with a similar functional outcome and quality of life after surgery. Over 93% of IndC patients would undergo the same procedure again, and 98% would recommend IPAA to others with IndC. Patients with IndC should not be precluded from having IPAA surgery. Total Fully Surgery BM continent again Ind 7 (5–10) 70.3% (n⫽115) UC (n⫽1399) 7 (5–9) 73.7% Median (IQR)
93.3%
Q. of life
Q. of Level of Level of health energy happiness
9 (8–10) 8 (7–10) 8 (6–9) 10 (8–10)
96.5%* 9 (8–10) 9 (8–10) 8 (7–9) 10 (9–10) *p⬍0.05, Chi squared test
HMO. Participants completed a telephone survey administered by trained personnel, blinded to the study intent, which included demographics, the Rome I criteria, SF-36, Psychosomatic checklist, the Novartis IBS-QOL instrument (for respondents meeting Rome I criteria), and other burden of illness items. Patient records from the health plan provided diagnoses from any inpatient or outpatient visits for the year of the survey. Respondents who did and did not meet the Rome I criteria were compared with respect to demographic and HRQOL variables using Fisher’s Exact and Wilcoxon rank-sums tests. Effect sizes were expressed as standardized mean differences (d). Results: Of the 2354 people contacted, 1032 (44%) agreed to participate. A total of 94 (9%) were classified as having IBS by Rome I criteria. All demographic variables including age, gender, race, marital status, education and income were comparable between IBS and non-IBS respondents. The sample was 60% female, 40% Hispanic, and the mean age was 39.73 (SD⫽9.84). Only 4 (0.5%) and 1 (1.2%) of the non-IBS and IBS participants, respectively, received a diagnosis of IBS while under medical care during the last year. Respondents with IBS had significantly (p⬍.0001) lower scores on all 8 subscales and the Physical and Mental Health Summary Scores of the SF-36 compared to respondents not suffering from IBS (d’s range .44 – .86). The Psychosomatic Checklist scores were significantly (p⬍.0001) higher for IBS than non-IBS respondents (d⫽.75), indicating more frequent and severe somatic complaints. Conclusion: Despite the fact that almost no one in the sample was diagnosed with IBS by a physician during the past year, 9% of the sample met the Rome I criteria for IBS. Based on measures of generic and diseasespecific HRQOL, these respondents experienced significant disease burden.
746 Lack of utility of risk factors in predicting symptomatic ulcers and ulcer complications on non-steroidal anti-inflammatory drugs (NSAIDs) Eisen G. on behalf of the CLASS investigators. Vanderbilt University Medical Center, Department of Medicine, Nashville, TN 37232-2279, United States; and Clinical Research and Development, G.D. Searle, Skokie, IL 60077. Data from the CLASS study were analyzed to identify patients at risk for NSAID-related symptomatic ulcers and ulcer complications. Univariate and multivariate analysis of potential risk factors for symptomatic ulcers and ulcer complications was performed in patients on conventional NSAIDs. Univariate analysis identified the following as significant risk factors for NSAID-associated symptomatic ulcers and ulcer complications (relative risk): age ⱖ 75 y (3.7), history of ulcer disease (2.7), history of GI bleeding (3.4), aspirin use (2.3), cardiovascular disease (1.6), and H. pylori ??positivity (2.0). Multivariate analysis identified age ⱖ 75 y, history of ulcer disease, and aspirin use as the most important risk factors (relative risk of 3.3, 2.6, and 2.1, respectively). Patients on celecoxib were most at risk if they were on concurrent low-dose aspirin. This study confirms the NSAID risk factor analysis of the MUCOSA trial and that risk increases non-additively with the number of risk factors. However, most events in patients treated with conventional NSAIDs occur in patients at low or no risk. Sponsored by GD Searle & Co.
747 Prevalence and health-related quality of life (HRQOL) associated with irritable bowel syndrome in a community sample Eisen GM, Weinfurt KP*, Hurley J⫹, Zacker C#, Coombs L*, Maher S*, Schulman KA.* Vanderbilt University Medical Center, Duke University Medical Center*, Novartis Pharmaceuticals#, Southwest Center for Managed Care Research, Lovelace Respiratory Research Institute⫹. Purpose: To determine the prevalence and HRQOL of Irritable Bowel Syndrome (IBS) in a managed care organization in the US Methods: A cross-sectional/case-control study was performed on a random sample of the 1998 and 1999 enrollment files of the Lovelace health plan
748 The economic burden of irritable bowel syndrome in a managed care organization Eisen GM, Weinfurt KP*, Hurley J⫹, Zacker C#, Coombs L*, Maher S*, Schulman KA.* Vanderbilt University Medical Center, Duke University Medical Center*, Novartis Pharmaceuticals#, Southwest Center for Managed Care Research, Lovelace Respiratory Research Institute⫹. Background: The costs of IBS for the US have been estimated at 4 – 8 billion dollars/year. Widely varying estimates may be due to limited access to all sources of direct medical expenditures. Aim: To determine the economic burden of IBS in a managed care setting where all direct expenditures, including inpatient/outpatient care and pharmaceutical use, are captured. Methods: A cross-sectional/case-control study was performed on a random sample of the 1998 and 1999 enrollment files of the Lovelace health plan HMO. This methodology captured individuals in the health plan regardless if they had sought health care in the previous year. Cases were determined by the Rome I criteria. Outpatient/inpatient charges and pharmaceutical charges for the previous 12 months were obtained for all individuals completing the telephone survey using the SCMCR Managed Care Database. All charges were expressed in 1999 dollars. Resource utilization and costs were compared between groups using bootstrapped 95% confidence intervals. Results: Of the 2354 people contacted, 1032 (44%) agreed to participate. A total of 94 (9%) were classified as having IBS by Rome I criteria. All demographic variables including age, gender, race, marital status, education and income were comparable between IBS and non-IBS respondents. The sample was 60% female, 40% Hispanic, and the mean age was 39.73 (SD⫽9.84). Respondents with IBS had a greater mean number of outpatient visits in the preceding year compared to non-IBS respondents (9.10 vs. 6.85; 95% C.I., 0.3 – 5.2). Respondents with and without IBS did not differ in the number of hospitalizations. Compared to all other respondents, those with IBS used more medications per year on average (5.9 vs. 4.8; 95% C.I. .06 – 2.32). There was a trend toward increased charges for both outpatient visits (median $934 vs. $680; 95% C.I. $⫺32.45 – $514.93) and prescription charges (median $285 vs. $241; 95% C.I. $⫺50.48 – $226.11) for IBS respondents compared to non-IBS respondents. Inpatient charges did not