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Background: Irritable bowel syndrome (IBS) is a disorder of gut–brain interaction characterized by abdominal pain and altered bowel habits, with patient‐perceived dissatisfaction of treatment symptom control. We assessed disease burden, satisfaction with medication use, and impact on activities, in participants with IBS with constipation (IBS‐C) and diarrhea (IBS‐D). Methods: This study assessed data from a large, United States survey of adults querying demographics, comorbid conditions, quality of life, medication use, satisfaction with symptom control, and work productivity. Participants were grouped into the IBS‐C or IBS‐D cohort if they met Rome IV criteria, with controls matched 1:1 according to age, sex, race, region, and Charlson Comorbidity Index score. All data were self‐reported. Key Results: Nine hundred and ten participants with IBS‐C and 669 with IBS‐D were matched to controls. The most reported symptoms were abdominal discomfort for IBS‐C and abdominal pain and abdominal discomfort for IBS‐D. Among the IBS‐C and IBS‐D cohorts, 74.2% and 65.9%, respectively, took prescription and/or over‐the‐counter medication for their symptoms. Respondents were more dissatisfied than satisfied with control of their symptoms. Respondents taking prescription medication(s) with or without over‐the‐counter medication(s) reported better symptom control than respondents only taking over‐the‐counter medications (p < 0.001). There was significantly higher mean presenteeism, work productivity loss, and daily activity impairment (p < 0.001 for all) in respondents with IBS compared with controls. Conclusions and Inferences: This study provides insight into respondents' experiences of IBS symptoms, including the impact on daily activity, as well as satisfaction with control of symptoms and prescription and over‐the‐counter medications. [ABSTRACT FROM AUTHOR]

Background: Chronic idiopathic constipation (CIC) is a disorder of gut–brain interaction characterized by a variety of bowel movement‐related and abdominal symptoms. A greater understanding of medication use and satisfaction with symptom control may provide insights to optimize patient care. Therefore, we explored these aspects of the disorder in adults with CIC. Methods: This study assessed data collected from a large nationwide survey of adult participants in the United States, querying demographics, clinical characteristics, and comorbid conditions, as well as medication use, care‐seeking behaviors, and satisfaction with symptom control. Participants were grouped into the CIC cohort if they met Rome IV criteria, with controls matched 1:1 according to age, sex, race, region, and Charlson Comorbidity Index score. All data were self‐reported. Key Results: Two thousand five hundred and thirty‐three participants with CIC were matched 1:1 to controls. In the CIC cohort, abdominal pain was the most reported symptom leading to medication use: 15.9% of respondents were receiving a prescription medication in addition to an over‐the‐counter medication, while 26.3% were taking neither. In addition, only one‐third were satisfied with the control of their symptoms; however, satisfaction was significantly higher in respondents taking a prescription medication (p < 0.001). The proportion of reported comorbidities was significantly higher in the CIC cohort versus the control cohort, with chronic pain, anxiety, and depression among the highest (p < 0.001 for all). Conclusions and Inferences: This study emphasizes the need for better communication regarding prescription medications and their benefits, with the goal of further improving CIC patients' overall symptoms. [ABSTRACT FROM AUTHOR]

The article presents the discussion on highlighting the important issue of chronic opioid use among patients with gastrointestinal disorders concerning about the high prevalence of opioid use among patients with gastrointestinal disorders.

Objective: The aim of this study was to examine how calibration uncertainty affects the overall uncertainty of a mathematical model and to evaluate potential drivers of calibration uncertainty. Methods: A lifetime Markov model of the natural history of human papillomavirus (HPV) infection and cervical disease was developed to assess the cost effectiveness of a hypothetical HPV vaccine. Published data on cervical cancer incidence and mortality and prevalence of pre-cursor lesions were used as endpoints to calibrate the age- and HPV-type-specific transition probabilities between health states using the Nelder-Mead simplex method of calibration. A conventional probabilistic sensitivity analysis (PSA) was performed to assess uncertainty in vaccine efficacy, cost and utility estimates. To quantify the uncertainty around calibrated transition probabilities, a second PSA (calibration PSA) was performed using 25 distinct combinations of objective functions and starting simplexes. Results: The initial calibration produced an incremental cost-effectiveness ratio (ICER) of $US4300 per QALY for vaccination compared with no vaccination, and the conventional PSA gave a 95% credible interval of dominant to $US9800 around this estimate (2005 values). The 95% credible interval for the ICERs in the calibration PSA ranged from $US1000 to $US37 700. Conclusions: Compared with a conventional PSA, the calibration PSA results reveal a greater level of uncertainty in cost-effectiveness results. Sensitivity analyses around model calibration should be performed to account for uncertainty arising from the calibration process. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the burden of chronic constipation (CC) and the use of drugs to treat constipation (DTC) in 2 complementary data sources., Design: Retrospective cohort study., Setting and Participants: US nursing home residents aged ≥65 years with CC., Methods: We conducted 2 retrospective cohort studies in parallel using (1) 2016 electronic health record (EHR) data from 126 nursing homes and (2) 2014-2016 Medicare claims, each linked with the Minimum Data Set (MDS). CC was defined as (1) the MDS constipation indicator and/or (2) chronic DTC use. We described the prevalence and incidence rate of CC and the use of DTC., Results: In the EHR cohort, we identified 25,739 residents (71.8%) with CC during 2016. Among residents with prevalent CC, 37% received a DTC, with an average duration of use of 19 days per resident-month during follow-up. The most frequently prescribed DTC classes included osmotic (22.6%), stimulant (20.9%), and emollient (17.9%) laxatives. In the Medicare cohort, a total of 245,578 residents (37.5%) had CC. Among residents with prevalent CC, 59% received a DTC and slightly more than half (55%) were prescribed an osmotic laxative. Duration of use was shorter (10 days per resident-month) in the Medicare (vs EHR) cohort., Conclusions and Implications: The burden of CC is high among nursing home residents. The differences in the estimates between the EHR and Medicare data confirm the importance of using secondary data sources that include over-the-counter drugs and other treatments unobservable in Medicare Part D claims to assess the burden of CC and DTC use in this population., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Goals: This study aimed to characterize the impact of stool consistency on patient-reported bowel movement (BM) satisfaction in patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation, with a focus on linaclotide., Background: As new medications for constipation become available, understanding patients' perceptions of treatment effects may help clinicians manage patient expectations and inform clinical decision-making., Materials and Methods: Data were derived from the Chronic Constipation and IBS-C Treatment and Outcomes Real-world Research Platform (CONTOR) study from 2 patient-reported 7-day daily BM diaries to create a dataset of 2922 diaries representing 26,524 BMs for 1806 participants. Binary variables were created for: medication(s) used in the past 24 hours and categorization of BMs as loose or watery stools (LoWS), hard or lumpy stools (HoLS), or intermediate (neither LoWS nor HoLS). The relationship between stool consistency, medication use, and BM satisfaction was analyzed using logistic regression with SEs corrected for repeated observations., Results: BMs characterized as intermediate stools and LoWS were satisfactory more often (61.2% and 51.2%, respectively) than HoLS (19.4%). Participants who reported taking linaclotide rated a similar proportion of BMs as satisfactory when described as LoWS (65.6%) or intermediate (64.1%). Linaclotide use was associated with higher odds of BMs being reported as satisfactory compared with nonlinaclotide use (odds ratio: 1.23, P<0.05)., Conclusions: Overall, CONTOR participants were more likely to report BMs classified as LoWS or intermediate as satisfactory, versus HoLS. Participants taking linaclotide were more likely to be satisfied, particularly those reporting LoWS, versus those not taking linaclotide.

Background: Recent clinical trial data have demonstrated that 3 years vs 1 year of adjuvant imatinib therapy for patients with surgically resected Kit+ Gastrointestinal Stromal Tumors (GIST) leads to a significant improvement in recurrence-free survival and overall survival. This study assesses the cost-effectiveness of treating patients with 3 years vs 1 year of imatinib from a US payer's perspective., Methods: A Markov model was developed to predict GIST recurrence and treatment costs. Patients enter the model after surgery and transition among three health states: free of recurrence, recurrence, and death. Recurrence, mortality, costs, and utilities were derived from clinical trial and published literature. Expected costs and quality-adjusted life years (QALYs) were estimated and discounted at 3%/year. Deterministic and probabilistic sensitivity analyses were conducted., Results: Patients receiving 3 years of imatinib had higher QALYs (8.53 vs 7.18) than those receiving 1 year of imatinib. Total lifetime per-patient cost was $302,100 for 3 years vs $217,800 for 1 year of imatinib. Incremental cost effectiveness ratio of 3 years vs 1 year of imatinib was $62,600/QALY. Model results were sensitive to long-term rate of GIST recurrence (beyond 5 years) and cost of imatinib. At a threshold of $100,000/QALY, 3 years vs 1 year of imatinib was cost-effective in 100% of simulations., Limitations: The model is a simplified representation of disease natural history and may not account for all possible health states and complications associated with disease. Resource utilization on treatment was estimated using the resource use data from previous trials, therefore calculated medical costs might be over-estimated compared to the real-world setting., Conclusions: Model results suggest that treatment with 3 years vs 1 year of imatinib is cost-effective at a $100,000/QALY threshold. Clinical and economic results suggest treating surgically resected Kit+ GIST patients with 3 years of imatinib would result in improved quality-adjusted survival.

Objectives: To assess the impact of simulating temporal changes in health-care practice patterns when calibrating longitudinal models to cross-sectional data., Methods: A Markov model of cervical cancer was calibrated to recent age-specific US data on the prevalence of cervical abnormalities, cervical cancer incidence, and related mortality. The impact of failing to account for temporal changes in screening practices was assessed by comparing results from 1) a conventional calibration that incorrectly assumed that all women had been exposed to current screening practices in the past and 2) an historically accurate calibration that reflected the fact that US women 65 years of age and older had not received currently available screening practices at younger ages., Results: The parameter set derived from conventional calibration produced a cervical cancer incidence rate of 13.4 per 100,000 among women aged 65 years and older, which is equal to the target end point. However, when this parameter set was used in the model to simulate the effects of historically correct screening, cervical incidence and related mortality in the 65 years and older age group were overestimated by 18% and 47%, respectively. Finally, when the parameter set was correctly calibrated by assuming historical changes in screening in the calibration process, excellent calibration to both incidence and mortality was obtained., Conclusions: Calibrating longitudinal models to cross-sectional data without accounting for temporal changes in clinical practice may result in a parameter set that is not as optimized as it appears and may lead to bias in evaluating the effectiveness of interventions., (Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Background: Imatinib mesylate, an orally administered kinase inhibitor that targets the Kit (CD117) protein, currently has 10 approved indications including treatment of chronic myelogenous leukemia and metastatic gastrointestinal stromal tumors (GIST). Treatment with adjuvant imatinib following surgical resection of localized Kit-positive GIST, the most recent FDA-approved indication (December 2008), has been shown to significantly improve recurrence-free survival (RFS) compared with surgical resection alone. Although adjuvant imatinib has proven effective in clinical trials, it is important to consider the economic impact to health plans of introducing imatinib in accordance with its new labeled indication., Objective: To evaluate the budgetary impact over a 3-year time horizon of treating patients with localized Kit-positive GIST with 1 year of adjuvant imatinib following surgical resection., Methods: A Markov model was developed to predict patients' transitions across health states defined by initial treatment (surgical resection followed by adjuvant imatinib 400 milligrams [mg] daily versus surgical resection alone), recurrence, and progression. Treatments for a first recurrence were (a) imatinib 400 mg daily for recurrences following resection only or after completion of 1 year of treatment with imatinib 400 mg daily and (b) imatinib 800 mg daily for recurrence during active treatment with imatinib 400 mg daily. Treatments for further progression were imatinib 800 mg daily, sunitinib, or best supportive care (BSC) following imatinib 400 mg per day, and sunitinib or BSC following imatinib 800 mg daily. Recurrence rates were derived from the American College of Surgeons Oncology Group (ACOSOG) Z9001 clinical trial, which compared 1 year of adjuvant imatinib following surgical resection with surgical resection only. The total number of patients with localized and surgically resected GIST (incidence rate of 0.36 per 100,000) was estimated from epidemiologic studies of GIST. Uptake of treatment with imatinib was estimated from unpublished data from qualitative market research funded by the study sponsor. The uptake rate assumptions reflected both (a) the percentage of patients with Kitpositive disease and (b) the percentage of clinically eligible patients who would use imatinib. Costs were estimated by combining unit costs from published sources with expected resource utilization based on the clinical trial publication and National Comprehensive Cancer Network guidelines on the treatment of patients with GIST. To obtain estimates of the budgetary impact, we compared estimated health care costs with versus without adjuvant imatinib, where health care costs with imatinib reflected the costs of treatment minus cost offsets associated with delayed or avoided recurrence or progression. All "with" scenarios assumed no additional uses other than surgically resected localized Kit-positive GIST (i.e., no change in off-label use of imatinib). The budgetary impact was estimated for the first 3 years after the introduction of adjuvant imatinib in accordance with its new labeled indication in a hypothetical plan population of 10 million persons. Results were calculated both as total budgetary impact and as per member per month (PMPM) cost in 2009 dollars. Sensitivity analyses were performed to test the robustness of model results to changes in parameter estimates., Results: The model predicted 36 incident resected GIST cases per year in a health plan of 10 million members. The estimated counts of cases treated with adjuvant imatinib were 10.8, 16.2, and 21.6 in the first, second, and third years after introduction, respectively, with the annual increases attributable to changes in the proportion of patients with resected GIST assumed to use imatinib (30% in year 1, rising to 45% in year 2 and 60% in year 3). The model predicted that treatment of these cases with imatinib will increase pharmacy costs by an additional $505,144 in the first year, $757,717 in the second year, and $1,010,289 in the third year. Increased resource use associated with monitoring patients during and after treatment with adjuvant imatinib would cost an additional $21,564, $38,145, and $56,605 in the first, second, and third years, respectively. Recurrence would be avoided or delayed in 7 patients over the 3-year period. Avoided or delayed recurrences would result in cost offsets of $61,583 in the first year, $156,702 in the second year, and $233,849 in the third year. The net budgetary impact was estimated to be $465,126 in the first year (less than $0.01 PMPM), $639,159 in the second year ($0.01 PMPM), and $833,044 in the third year ($0.01 PMPM). Results of sensitivity analyses indicated that the budgetary impact in the third year is most sensitive to changes in the price of adjuvant imatinib and recurrence rates., Conclusions: The model predicted that the introduction of adjuvant imatinib for treatment of surgically resected, localized, Kit-positive GIST will lead to a net budgetary impact of $0.01 PMPM in the third year after introduction assuming change in use only in accordance with the new labeled indication. Approximately 11.7%-21.9% of the cost of adjuvant imatinib is offset by the reduction in costs associated with GIST recurrence.