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Validation of the reflux symptom questionnaire
AJG – September, 2000
Abstracts
755 Validation of the reflux symptom questionnaire Hardtke Cyndy L, Romero Yvonne MD, Cameron Alan J MD*, Schaid Daniel J PhD, Murray Joseph A MD, Conio Massimo MD, Burgart Lawrence J MD, Locke Giles R III MD. Mayo Clinic, Rochester, Minnesota, United States. Purpose: To prospectively validate the Reflux Symptom Questionnaire (RSQ) developed by Locke, et al. (Mayo Clin Proc 1994; 69: 539 –547). Background: The RSQ has 17 items, of which 11 concern the type, frequency and duration of gastroesophageal reflux disease (GERD) symptoms, medications taken for GERD and any prior esophageal diagnoses or surgery. This instrument was developed using validated items from the Gastroesophageal Reflux Questionnaire (GERQ). Methods: The RSQ was prospectively administered to potential subjects prior to endoscopy (EGD). Subjects were either first degree relatives of index patients with Barrett’s esophagus (BE)(Relatives), or patients who denied a family history of BE or esophageal cancer referred by their physicians for EGD (Controls). Criteria for GERD symptoms included heartburn at least once per week in the past year with at least one of the following criteria: relief with antacids, night awakening or radiation toward the neck, OR acid regurgitation at least once per week. Subjects were excluded if they had previous EGD. The gold standard for GERD was erosive changes of the esophagus or BE at EGD. Results: 294 subjects participated: 136 of 212 (63%) Relatives and 158 of 160 (99%) Controls. Participants included 178 males (88 Relatives, 90 Controls) and 116 females (48 Relatives, 68 Controls) of whom 113 Relatives and 151 Controls met criteria for GERD symptoms as per the RSQ. Relatives were younger, median age 47 versus 55 years (p⫽0.007).
RSQ GERD ⫹ RSQ GERD ⫺ Total
EGD GERD ⴙ
EGD GERD ⴚ
152 16 168
112 14 126
The overall sensitivity and specificity of the RSQ for erosive reflux disease is 90% and 11%, respectively. Among persons without a family history of BE, the respective sensitivity and specificity of the RSQ for erosive reflux is 97% and 6%. Data not shown. Conclusions: Preliminary analysis suggests that the RSQ is a sensitive instrument for the detection of GERD symptoms.
756 Yield of screening colonoscopy in persons aged 40 to 49 years Imperiale TF, Wagner DR, Lin CY, Larkin GN, Rogge JD, Ransohoff DF. Indiana University School of Medicine, Indianapolis Gastroenterology Research Foundation, Eli Lilly & Co. Inc., Indianapolis, IN, and University of North Carolina, Chapel Hill, NC. Background: Approximately 7% of colorectal cancers (CRC) occur in persons aged ⬍ 50 years. Although screening colonoscopy (CY) has been advocated for people ⱖ age 50 based on indirect evidence, there are no published data on the yield of CY for detection of neoplasia in persons 40 – 49 years old. Methods: Eli Lilly & Co, Inc. provide screening CY to employees, retirees, and their dependents aged 40 years and older. We reviewed procedure reports and histologic findings from consecutive persons aged 40 – 49 who underwent screening CY. Colorectal pathology was characterized according to the most advanced lesion proximally (splenic flexure) and distally. An advanced lesion was defined as villous histology, dysplasia or cancer. Findings in men vs. women were compared with relative risks (RR) and 95% confidence intervals (CI). Results: From 9/95 to 4/00, 906 persons aged 40 – 49 were screened with CY (mean age 44.8 years; 61% men, 77% Caucasian). Overall, 79% had no polyps, 10% had hyperplastic polyps, 9% had tubular adenomas, and 21 (2%) had advanced lesions, none of which were cancers (95% CI for
2631
cancer: 0 – 0.4%). Fourteen (64%) of 22 advanced lesions were distal and within reach of the sigmoidoscope. Of 8 advanced proximal neoplasms (APN), 6 had no distal sentinel polyp; 120 screening CYs (CI 69 – 454) would be needed to detect one APN among persons with no distal neoplasm. Women were less likely to have any polyp (16% vs 24%; RR⫽0.67; CI 0.43– 0.86) and any neoplasm (8% vs 12%; RR⫽0.66; CI 0.40 – 0.99). Conclusion: CRC is very rare in persons aged 40 – 49 years and is substantially lower than in older persons. Advanced neoplasia is uncommon and tends to be distal in location. The low yield of screening CY in this age group supports current recommendations about when to begin CRC screening. Identification of risk factors for ‘early‘ CRC and isolated advanced proximal neoplasms would be useful in order to target screening CY for younger age groups.
757 Impact of Lotronex on time lost from work in female patients with diarrhea-predominant IBS Jhingran P. Ph.D., Decker C. M.S., Ricci JF M.B.A., Watson M. Ph.D., Northcutt A. M.S. Glaxo Wellcome Inc., Research Triangle Park, NC, USA. Purpose: IBS is characterized by recurrent abdominal pain, discomfort, and alterations in bowel function. Previous studies have shown that multiple and debilitating symptoms of IBS can impact daily life, functional status, direct medical costs, and productivity. The objective of the study was to assess the impact of Lotronex on the time lost from work in female patients with diarrhea-predominant IBS who were working full-time (ⱖ30 hours a week). Methods: Time lost from work was measured at baseline and at Week 12/Final Visit in two identically designed, double-blind, placebo-controlled, 12-week randomized clinical trials of Lotronex 1 mg twice daily in females with diarrhea predominant IBS. Measures of time lost included the number of days over the preceding 4 weeks that subjects 1) were unable to attend work or 2) needed to reduce the length of their workday because of their IBS symptoms. Treatment groups were compared using a rank analysis of covariance adjusting for baseline. The economic implications of measured productivity changes were estimated using 1999 wage data from the US Bureau of Labor Statistics. Data from the 2 trials were combined for all analyses. Results: Of 903 subjects enrolled in the two trials, 397 (44%) were working full-time at baseline and study end. Analysis of combined studies on the 397 patients showed that at baseline, Lotronex and placebo diarrheapredominant subjects missed 1.25 days and 1 day (median) over the preceding 4 weeks, respectively. At Week 12/Final visit, Lotronex and placebo patients missed 0 and 0.5 day (median), respectively (p⬍0.001). Assuming an 8-hour workday and total hourly benefits of $20.29, the additional half day reduction in productivity loss for Lotronex patients translates into a $81-savings to employers. Constipation was the only adverse event reported more frequently with Lotronex than with placebo, 39% versus 14%, respectively. Conclusion: Lotronex reduces time lost from work in diarrhea predominant IBS females working full-time by half-a-day, translating into a $81 savings per month for their employers. This study was sponsored by Glaxo Wellcome, Inc.
758 Patient satisfaction in Lotronex® (Aloseton HCl) treated nonconstipated irritable bowel syndrome (IBS) females Jhingran P. Ph.D., Bagby BA M.B.A, Decker C. M.S., Gordon S. M.S.N., Markowitz MA M.D., Carter E. M.D. Glaxo Wellcome Inc., RTP, NC, USA. Purpose: Traditional medications have not shown consistent benefits in addressing the multiple symptoms of IBS and may cause unwanted side effects resulting in lower patient satisfaction. This study evaluated patient
Abstracts
755 Validation of the reflux symptom questionnaire Hardtke Cyndy L, Romero Yvonne MD, Cameron Alan J MD*, Schaid Daniel J PhD, Murray Joseph A MD, Conio Massimo MD, Burgart Lawrence J MD, Locke Giles R III MD. Mayo Clinic, Rochester, Minnesota, United States. Purpose: To prospectively validate the Reflux Symptom Questionnaire (RSQ) developed by Locke, et al. (Mayo Clin Proc 1994; 69: 539 –547). Background: The RSQ has 17 items, of which 11 concern the type, frequency and duration of gastroesophageal reflux disease (GERD) symptoms, medications taken for GERD and any prior esophageal diagnoses or surgery. This instrument was developed using validated items from the Gastroesophageal Reflux Questionnaire (GERQ). Methods: The RSQ was prospectively administered to potential subjects prior to endoscopy (EGD). Subjects were either first degree relatives of index patients with Barrett’s esophagus (BE)(Relatives), or patients who denied a family history of BE or esophageal cancer referred by their physicians for EGD (Controls). Criteria for GERD symptoms included heartburn at least once per week in the past year with at least one of the following criteria: relief with antacids, night awakening or radiation toward the neck, OR acid regurgitation at least once per week. Subjects were excluded if they had previous EGD. The gold standard for GERD was erosive changes of the esophagus or BE at EGD. Results: 294 subjects participated: 136 of 212 (63%) Relatives and 158 of 160 (99%) Controls. Participants included 178 males (88 Relatives, 90 Controls) and 116 females (48 Relatives, 68 Controls) of whom 113 Relatives and 151 Controls met criteria for GERD symptoms as per the RSQ. Relatives were younger, median age 47 versus 55 years (p⫽0.007).
RSQ GERD ⫹ RSQ GERD ⫺ Total
EGD GERD ⴙ
EGD GERD ⴚ
152 16 168
112 14 126
The overall sensitivity and specificity of the RSQ for erosive reflux disease is 90% and 11%, respectively. Among persons without a family history of BE, the respective sensitivity and specificity of the RSQ for erosive reflux is 97% and 6%. Data not shown. Conclusions: Preliminary analysis suggests that the RSQ is a sensitive instrument for the detection of GERD symptoms.
756 Yield of screening colonoscopy in persons aged 40 to 49 years Imperiale TF, Wagner DR, Lin CY, Larkin GN, Rogge JD, Ransohoff DF. Indiana University School of Medicine, Indianapolis Gastroenterology Research Foundation, Eli Lilly & Co. Inc., Indianapolis, IN, and University of North Carolina, Chapel Hill, NC. Background: Approximately 7% of colorectal cancers (CRC) occur in persons aged ⬍ 50 years. Although screening colonoscopy (CY) has been advocated for people ⱖ age 50 based on indirect evidence, there are no published data on the yield of CY for detection of neoplasia in persons 40 – 49 years old. Methods: Eli Lilly & Co, Inc. provide screening CY to employees, retirees, and their dependents aged 40 years and older. We reviewed procedure reports and histologic findings from consecutive persons aged 40 – 49 who underwent screening CY. Colorectal pathology was characterized according to the most advanced lesion proximally (splenic flexure) and distally. An advanced lesion was defined as villous histology, dysplasia or cancer. Findings in men vs. women were compared with relative risks (RR) and 95% confidence intervals (CI). Results: From 9/95 to 4/00, 906 persons aged 40 – 49 were screened with CY (mean age 44.8 years; 61% men, 77% Caucasian). Overall, 79% had no polyps, 10% had hyperplastic polyps, 9% had tubular adenomas, and 21 (2%) had advanced lesions, none of which were cancers (95% CI for
2631
cancer: 0 – 0.4%). Fourteen (64%) of 22 advanced lesions were distal and within reach of the sigmoidoscope. Of 8 advanced proximal neoplasms (APN), 6 had no distal sentinel polyp; 120 screening CYs (CI 69 – 454) would be needed to detect one APN among persons with no distal neoplasm. Women were less likely to have any polyp (16% vs 24%; RR⫽0.67; CI 0.43– 0.86) and any neoplasm (8% vs 12%; RR⫽0.66; CI 0.40 – 0.99). Conclusion: CRC is very rare in persons aged 40 – 49 years and is substantially lower than in older persons. Advanced neoplasia is uncommon and tends to be distal in location. The low yield of screening CY in this age group supports current recommendations about when to begin CRC screening. Identification of risk factors for ‘early‘ CRC and isolated advanced proximal neoplasms would be useful in order to target screening CY for younger age groups.
757 Impact of Lotronex on time lost from work in female patients with diarrhea-predominant IBS Jhingran P. Ph.D., Decker C. M.S., Ricci JF M.B.A., Watson M. Ph.D., Northcutt A. M.S. Glaxo Wellcome Inc., Research Triangle Park, NC, USA. Purpose: IBS is characterized by recurrent abdominal pain, discomfort, and alterations in bowel function. Previous studies have shown that multiple and debilitating symptoms of IBS can impact daily life, functional status, direct medical costs, and productivity. The objective of the study was to assess the impact of Lotronex on the time lost from work in female patients with diarrhea-predominant IBS who were working full-time (ⱖ30 hours a week). Methods: Time lost from work was measured at baseline and at Week 12/Final Visit in two identically designed, double-blind, placebo-controlled, 12-week randomized clinical trials of Lotronex 1 mg twice daily in females with diarrhea predominant IBS. Measures of time lost included the number of days over the preceding 4 weeks that subjects 1) were unable to attend work or 2) needed to reduce the length of their workday because of their IBS symptoms. Treatment groups were compared using a rank analysis of covariance adjusting for baseline. The economic implications of measured productivity changes were estimated using 1999 wage data from the US Bureau of Labor Statistics. Data from the 2 trials were combined for all analyses. Results: Of 903 subjects enrolled in the two trials, 397 (44%) were working full-time at baseline and study end. Analysis of combined studies on the 397 patients showed that at baseline, Lotronex and placebo diarrheapredominant subjects missed 1.25 days and 1 day (median) over the preceding 4 weeks, respectively. At Week 12/Final visit, Lotronex and placebo patients missed 0 and 0.5 day (median), respectively (p⬍0.001). Assuming an 8-hour workday and total hourly benefits of $20.29, the additional half day reduction in productivity loss for Lotronex patients translates into a $81-savings to employers. Constipation was the only adverse event reported more frequently with Lotronex than with placebo, 39% versus 14%, respectively. Conclusion: Lotronex reduces time lost from work in diarrhea predominant IBS females working full-time by half-a-day, translating into a $81 savings per month for their employers. This study was sponsored by Glaxo Wellcome, Inc.
758 Patient satisfaction in Lotronex® (Aloseton HCl) treated nonconstipated irritable bowel syndrome (IBS) females Jhingran P. Ph.D., Bagby BA M.B.A, Decker C. M.S., Gordon S. M.S.N., Markowitz MA M.D., Carter E. M.D. Glaxo Wellcome Inc., RTP, NC, USA. Purpose: Traditional medications have not shown consistent benefits in addressing the multiple symptoms of IBS and may cause unwanted side effects resulting in lower patient satisfaction. This study evaluated patient