Cost-effectiveness of an implantable gastric pacemaker in severe gastroparetics

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887 Health-related quality of life associated with irritable bowel syndrome patients: comparison to other chronic diseases Anne M. Rentz 1 , Lori Frank 1 *, Gabrielle Ciesla 1 , Leah Kleinman 2 and John Kim 3 . 1 Novartis Pharmaceuticals, East Hanover, New Jersey, United States; 2 MEDTAP International, Bethesda, Maryland, United States; and 3 MEDTAP International, Seattle, Washington, United States. Purpose: To further quantify the impact of IBS, a chronic functional GI disorder characterized by abdominal pain, bloating, constipation, and/or diarrhea, on health-related quality of life (HRQL) using SF-36 Survey data. Methods: Using SF-36 results from the published literature, scores of IBS patients were compared to those for the general US population and other chronic disease populations. Nine patient samples from different studies were compared. Two samples with Rome I-positive IBS were chosen for comparison: IBS-I (n 92): untreated IBS subjects from a study of a large US HMO; IBS-II (n 140): subjects suffering from IBS with constipation, a mix of treatment-seekers (from clinic referrals) and potential non-treat- ment seekers (from advertisement). Comparator disorders were chosen for similarity to IBS in terms of symptom characteristics (episodic/chronicity/ acute flare-ups): GERD (n 533), dyspepsia (n 126), migraine (n 344), asthma (n 914), panic disorder (n 73) and rheumatoid arthritis (n 693). Scores were also compared with US population norms (n 2,474). Statistical comparisons were made via t-tests, using a pooled estimate of variance. Results: IBS-I reported significantly lower mean scores than the US general population on all domains except physical functioning (PF), role- emotional, and mental health and poorer than GERD patients on general health (GH), vitality, and social functioning (p 0.05). Scores were also significantly worse than the asthma sample on bodily pain (BP) and the migraine sample on PF and GH (p 0.05). IBS-II scored significantly poorer than the US general population (all 8 domains) and GERD patients (all domains except PF) (p 0.05). IBS-II scored significantly lower than asthma patients (all domains except PF and GH) and migraine patients (all scales except role-physical and BP) (p 0.05). Dyspepsia patients scored lower on all domains compared to both IBS samples. Subjects with panic disorder and rheumatoid arthritis demonstrated significantly lower HRQL on most domains compared to IBS sufferers (p 0.05). Conclusions: IBS is associated with negative effects on HRQL relative to US population norms, GERD, asthma and migraine. In this analysis, non-treatment seekers demonstrated less HRQL impairment than did a sample which included treatment-seekers. 888 Cost-effectiveness of an implantable gastric pacemaker in severe gastroparetics Robert Richards, MD, Manish Kotecha BS, Irene Sarosiek, MD, Richard McCallum, MD, FACG. University of Kansas Medical Center, Kansas City, Kansas. Purpose: Gastric electrical stimulation (GES) [Medtronic] is a viable option for patients with severe refractory gastroparesis; however, the de- vice’s cost-effectiveness is not known. Methods: A Markov model was used to examine costs and quality- adjusted-life years (QALYs) of 2 strategies: (1) insertion of GES (2) conventional medical care. The experience of large hypothetic 30-year-old cohorts was simulated over a 5-year period. Transition state probabilities were estimated from an expert panel. QALYs were determined using the time trade-off in 14 patients with implanted GESs. Costs were estimated using a cost/charge ratio and Medicare reimbursement rates from 10 patients who had GES inserted at our institution. We used the 1999 average hourly earnings rate in Kansas for indirect patient costs. The analysis was performed from a societal perspective. Results: Assuming a 3% discount model, GES cost $11,067 per additional QALY saved (Table). Strategy Cost U.S. $ QALYs Incremental Cost/ QALY saved Standard care 37,095 1.47 GES 42,965 2.00 11,067 In a one-way sensitivity analysis, the hardware’s cost was varied from $3,000 –$10,000 (baseline $6,000). Within this range, GES cost $5,500 to $18,300 respectively per additional QALY saved. In the baseline model, it was assumed GES would achieve a reduction of 30% in hospital days vs. conventional treatment. GES remained cost-effective if a reduction of 15% in hospital days was achieved. Conclusions: For gastroparesis refractory to standard medical therapy, GES is a cost-effective treatment and remains cost-effective ($50,000 per additional QALY saved) as long as it reduces hospitalization by at least 15%. 889 The effect of previous endoscopic experiences on patients’ perceptions of lower gastrointestinal (LGI) endoscopic procedures Yehuda Ringel MD 1 , Lawrence J Brandt MD, FACG 2 , Christine B Dalton PA-C 1 , Yuming Hu PhD 1 , Huanguang Jia PhD 1 , Shrikant I Bangdiwala PhD 1 and Douglas A Drossman MD, FACG 1 1*. 1 Div. of Digestive Dis. and Nutrition, University of North Carolina, Chapel Hill, NC, United States; and 2 Div. of Gastroenterology, Monteflore Medical Center, New York, NY, United States. Purpose: Repeated Colonoscopy and Flexible Sigmoidoscopy (FS) are frequently used for screening and follow-up protocols in GI clinics. Anx- iety, discomfort and high levels of concerns can affect patients’ attitudes towards the procedures, as well as their compliance and adherence to screening and or follow-up recommendations. The aim of this study was to assess the effect of previous endoscopic experience on pre-procedural concerns, anticipated difficulty and post-procedural rating of difficulty in patients having LGI endoscopic procedure. Methods: A total of 548 patients presenting for LGI endoscopy (FS-171, Colonoscopy-377) were asked to complete a 2-part questionnaire. Prior to the procedure, patients rated their anticipated difficulty and degree of concern for each of 30 specific concerns (Am J Gastro, 1996). Following the procedure, patients rated their post-procedural actual difficulty. A 5-point scale was used for all ratings. T-test analyses were performed to examine the effects of previous experience with endoscopic procedures on the pre- and post-procedural variables of interest. Results: Patients who came for colonoscopy and who had previously experienced the same endoscopic procedure had fewer concerns (11.3 vs. 14.6, p 0.0002) and lower anticipated difficulty (0.67 vs. 0.944, p 0.005) compared to patients who came for colonoscopy but who had no previous endoscopic experience. Previous endoscopic experience, how- ever, does not affect the post-procedural actual difficulty ratings (0.59 vs. 0.63, p 0.66). For patients who came for FS, a history of previous FS did not affect any of the pre- or post-procedural variables. Interestingly, those who came for FS and who had previously undergone colonoscopy rated FS as more difficult than did those who had previously undergone FS (1.22 vs. 0.90, p 0.07) or those who had had no previous endoscopic experience (1.22 vs. 0.77, p 0.017). Conclusions: Unlike experience with procedures not requiring sedation (e.g., SF), previous endoscopic experience with sedation-associated proce- dures (e.g., colonoscopy) decreases the patients’ pre-procedural anticipated difficulty and degree of concerns. Neither affects the patients’ perception of the same procedure’s actual difficulty. Further studies are needed to assess these effects on compliance with repeated procedures. S279 AJG – September, Suppl., 2001 Abstracts

Transcript of Cost-effectiveness of an implantable gastric pacemaker in severe gastroparetics

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Health-related quality of life associated with irritable bowelsyndrome patients: comparison to other chronic diseasesAnne M. Rentz1, Lori Frank1*, Gabrielle Ciesla1, Leah Kleinman2 andJohn Kim3. 1Novartis Pharmaceuticals, East Hanover, New Jersey,United States; 2MEDTAP International, Bethesda, Maryland, UnitedStates; and 3MEDTAP International, Seattle, Washington, United States.

Purpose: To further quantify the impact of IBS, a chronic functional GIdisorder characterized by abdominal pain, bloating, constipation, and/ordiarrhea, on health-related quality of life (HRQL) using SF-36 Survey data.Methods: Using SF-36 results from the published literature, scores of IBSpatients were compared to those for the general US population and otherchronic disease populations. Nine patient samples from different studieswere compared. Two samples with Rome I-positive IBS were chosen forcomparison: IBS-I (n � 92): untreated IBS subjects from a study of a largeUS HMO; IBS-II (n � 140): subjects suffering from IBS with constipation,a mix of treatment-seekers (from clinic referrals) and potential non-treat-ment seekers (from advertisement). Comparator disorders were chosen forsimilarity to IBS in terms of symptom characteristics (episodic/chronicity/acute flare-ups): GERD (n � 533), dyspepsia (n � 126), migraine (n �344), asthma (n � 914), panic disorder (n � 73) and rheumatoid arthritis(n � 693). Scores were also compared with US population norms (n �2,474). Statistical comparisons were made via t-tests, using a pooledestimate of variance.Results: IBS-I reported significantly lower mean scores than the USgeneral population on all domains except physical functioning (PF), role-emotional, and mental health and poorer than GERD patients on generalhealth (GH), vitality, and social functioning (p � 0.05). Scores were alsosignificantly worse than the asthma sample on bodily pain (BP) and themigraine sample on PF and GH (p � 0.05). IBS-II scored significantlypoorer than the US general population (all 8 domains) and GERD patients(all domains except PF) (p � 0.05). IBS-II scored significantly lower thanasthma patients (all domains except PF and GH) and migraine patients (allscales except role-physical and BP) (p � 0.05). Dyspepsia patients scoredlower on all domains compared to both IBS samples. Subjects with panicdisorder and rheumatoid arthritis demonstrated significantly lower HRQLon most domains compared to IBS sufferers (p � 0.05).Conclusions: IBS is associated with negative effects on HRQL relative toUS population norms, GERD, asthma and migraine. In this analysis,non-treatment seekers demonstrated less HRQL impairment than did asample which included treatment-seekers.

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Cost-effectiveness of an implantable gastric pacemaker in severegastropareticsRobert Richards, MD, Manish Kotecha BS, Irene Sarosiek, MD, RichardMcCallum, MD, FACG. University of Kansas Medical Center, KansasCity, Kansas.

Purpose: Gastric electrical stimulation (GES) [Medtronic] is a viableoption for patients with severe refractory gastroparesis; however, the de-vice’s cost-effectiveness is not known.Methods: A Markov model was used to examine costs and quality-adjusted-life years (QALYs) of 2 strategies: (1) insertion of GES (2)conventional medical care. The experience of large hypothetic 30-year-oldcohorts was simulated over a 5-year period. Transition state probabilitieswere estimated from an expert panel. QALYs were determined using thetime trade-off in 14 patients with implanted GESs. Costs were estimatedusing a cost/charge ratio and Medicare reimbursement rates from 10patients who had GES inserted at our institution. We used the 1999 averagehourly earnings rate in Kansas for indirect patient costs. The analysis wasperformed from a societal perspective.

Results: Assuming a 3% discount model, GES cost $11,067 per additionalQALY saved (Table).

StrategyCost

U.S. $ QALYsIncremental Cost/

QALY saved

Standard care 37,095 1.47 –GES 42,965 2.00 11,067

In a one-way sensitivity analysis, the hardware’s cost was varied from$3,000–$10,000 (baseline � $6,000). Within this range, GES cost $5,500to $18,300 respectively per additional QALY saved. In the baseline model,it was assumed GES would achieve a reduction of 30% in hospital days vs.conventional treatment. GES remained cost-effective if a reduction of 15%in hospital days was achieved.

Conclusions: For gastroparesis refractory to standard medical therapy,GES is a cost-effective treatment and remains cost-effective (�$50,000 peradditional QALY saved) as long as it reduces hospitalization by at least15%.

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The effect of previous endoscopic experiences on patients’perceptions of lower gastrointestinal (LGI) endoscopic proceduresYehuda Ringel MD1, Lawrence J Brandt MD, FACG2, Christine BDalton PA-C1, Yuming Hu PhD1, Huanguang Jia PhD1, Shrikant IBangdiwala PhD1 and Douglas A Drossman MD, FACG11*. 1Div. ofDigestive Dis. and Nutrition, University of North Carolina, Chapel Hill,NC, United States; and 2Div. of Gastroenterology, Monteflore MedicalCenter, New York, NY, United States.

Purpose: Repeated Colonoscopy and Flexible Sigmoidoscopy (FS) arefrequently used for screening and follow-up protocols in GI clinics. Anx-iety, discomfort and high levels of concerns can affect patients’ attitudestowards the procedures, as well as their compliance and adherence toscreening and or follow-up recommendations. The aim of this study was toassess the effect of previous endoscopic experience on pre-proceduralconcerns, anticipated difficulty and post-procedural rating of difficulty inpatients having LGI endoscopic procedure.Methods: A total of 548 patients presenting for LGI endoscopy (FS-171,Colonoscopy-377) were asked to complete a 2-part questionnaire. Prior tothe procedure, patients rated their anticipated difficulty and degree ofconcern for each of 30 specific concerns (Am J Gastro, 1996). Followingthe procedure, patients rated their post-procedural actual difficulty. A5-point scale was used for all ratings. T-test analyses were performed toexamine the effects of previous experience with endoscopic procedures onthe pre- and post-procedural variables of interest.Results: Patients who came for colonoscopy and who had previouslyexperienced the same endoscopic procedure had fewer concerns (11.3 vs.14.6, p � 0.0002) and lower anticipated difficulty (0.67 vs. 0.944, p �0.005) compared to patients who came for colonoscopy but who had noprevious endoscopic experience. Previous endoscopic experience, how-ever, does not affect the post-procedural actual difficulty ratings (0.59 vs.0.63, p � 0.66). For patients who came for FS, a history of previous FS didnot affect any of the pre- or post-procedural variables. Interestingly, thosewho came for FS and who had previously undergone colonoscopy rated FSas more difficult than did those who had previously undergone FS (1.22 vs.0.90, p � 0.07) or those who had had no previous endoscopic experience(1.22 vs. 0.77, p � 0.017).Conclusions: Unlike experience with procedures not requiring sedation(e.g., SF), previous endoscopic experience with sedation-associated proce-dures (e.g., colonoscopy) decreases the patients’ pre-procedural anticipateddifficulty and degree of concerns. Neither affects the patients’ perception ofthe same procedure’s actual difficulty. Further studies are needed to assessthese effects on compliance with repeated procedures.

S279AJG – September, Suppl., 2001 Abstracts