Anita Chawla

Comorbidities in Patients With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation: A Review of the Literature From the Past Decade

Abstract Background: Irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) are common functional bowel disorders. Patients with IBS-C or CIC often present with ≥ 1 comorbidity that coincides with either of these conditions. These comorbidities may make underappreciated contributions to the patients overall disease burden. Objective: To identify the comorbidities that are the most frequently reported in patients with IBS-C or CIC in the medical literature. Methods: A literature search (January 2001–March 2012) was performed using the Medline and Medline In-Process databases. Studies of adult patients with IBS-C or CIC were selected, and the prevalence rates of the comorbidities were extracted and analyzed according to the body system affected. Results: A total of 70 distinct comorbidities were identified from 35 published studies. These comorbidities involved several body systems, including the gastrointestinal, genitourinary, psychiatric, endocrine, and allergic or immunologic systems. Functional dyspepsia and depression were the most common comorbidities in patients with IBS-C, whereas functional dyspepsia, diabetes, and depression were the most common comorbidities in patients with CIC. Conclusion: Patients with IBS-C or CIC frequently experience a wide range of comorbidities that contribute to their disease burden. Thus, we believe that medical professionals should consider common comorbidities when diagnosing and treating patients with IBS-C or CIC.

Biologic Disease-modifying Drug Treatment Patterns and Associated Costs for Patients with Rheumatoid Arthritis

Objective. To assess the influence of biologic treatment patterns on healthcare costs for patients with rheumatoid arthritis (RA) initiating tumor necrosis factor-α (TNF-α) antagonist therapy. Methods. Patients with 2 RA diagnoses (International Classification of Diseases, 9th ed, 714.xx), and without psoriasis or Crohn’s disease, were identified in a US employer-based insurance claims database. A sample of 2545 was constructed based on an index event of initiating TNF-α antagonist therapy and 30 months of continuous enrollment. Baseline characteristics were assessed in the 6-month pre-index period and treatment patterns were determined during the 12-month post-index period. Medical service and prescription drug costs were analyzed for Months 13–24 using multivariate regression analysis to control for baseline characteristics and time-varying confounding associated with treatment and disease severity. Results. In the first year after TNF-α initiation, 89% used a single TNF-α antagonist; only 9% and 2% had switched TNF-α antagonists or received non-TNF biologic disease-modifying antirheumatic drugs, respectively. Descriptive analyses revealed pairwise differences between groups (p < 0.05) in baseline characteristics (comorbidities, RA-related procedure use, and prescription drug use). Controlling for observed baseline characteristics, costs were greater for those treated with multiple vs single TNF-α antagonists: annual RA-related prescription drug costs (

Development of a shared decision-making tool to assist patients and clinicians with decisions on oral anticoagulant treatment for atrial fibrillation

8,340 vs

Estimating the incremental net health benefit of requirements for cardiovascular risk evaluation for diabetes therapies

7,058; p = 0.012), RA-related healthcare costs (

Utility values associated with advanced or metastatic non-small cell lung cancer: data needs for economic modeling

15,048 vs

Real-world utilization of molecular diagnostic testing and matched drug therapies in the treatment of metastatic cancers

13,312; p = 0.008), and total healthcare costs (

A Review of Long-Term Toxicity of Antiretroviral Treatment Regimens and Implications for an Aging Population

26,697 vs

Estimated cost of anticancer therapy directed by comprehensive genomic profiling (CGP) in a single-center study.

21,381; p < 0.001). Conclusion. In this sample, the majority of patients with RA were treated with a single TNF-α antagonist over the first year on therapy. For those who switched therapy, Year 2 RA-related and total direct healthcare costs were higher, adjusting for claims-based measures of RA disease severity.

PIH4 PERSONALIZED MEDICINE: TRENDS IN CLINICAL STUDIES BASED ON NATIONAL REGISTRY DATA

Abstract Objective: Decision aids (DAs) are increasingly used to operationalize shared decision-making (SDM) but their development is not often described. Decisions about oral anticoagulants (OACs) for atrial fibrillation (AF) involve a trade-off between lowering stroke risk and increasing OAC-associated bleeding risk, and consideration of how treatment affects lifestyle. The benefits and risks of OACs hinge upon a patient’s risk factors for stroke and bleeding and how they value these outcomes. We present the development of a DA about AF that estimates patients’ risks for stroke and bleeding and assesses their preferences for outcomes. Research design and methods: Based on a literature review and expert discussions, we identified stroke and major bleeding risk prediction models and embedded them into risk assessment modules. We identified the most important factors in choosing OAC treatment (warfarin used as the default reference OAC) through focus group discussions with AF patients who had used warfarin and clinician interviews. We then designed preference assessment and introductory modules accordingly. We integrated these modules into a prototype AF SDM tool and evaluated its usability through interviews. Results: Our tool included four modules: (1) introduction to AF and OAC treatment risks and benefits; (2) stroke risk assessment; (3) bleeding risk assessment; and (4) preference assessment. Interactive risk calculators estimated patient-specific stroke and bleeding risks; graphics were developed to communicate these risks. After cognitive interviews, the content was improved. The final AF tool calculates patient-specific risks and benefits of OAC treatment and couples these estimates with patient preferences to improve clinical decision-making. Conclusions: The AF SDM tool may help patients choose whether OAC treatment is best for them and represents a patient-centered, integrative approach to educate patients on the benefits and risks of OAC treatment. Future research is needed to evaluate this tool in a real-world setting. The development process presented can be applied to similar SDM tools.

A Systematic Review of the Economic and Humanistic Burden of Illness in Irritable Bowel Syndrome and Chronic Constipation

To evaluate the advantages and disadvantages of pre‐approval requirements for safety data to detect cardiovascular (CV) risk contained in the December 2008 U.S. Food and Drug Administration (FDA) guidance for developing type 2 diabetes drugs compared with the February 2008 FDA draft guidance from the perspective of diabetes population health.