Safety and patient outcomes with lubiprostone for up to 52 weeks in patients with irritable bowel syndrome with constipation

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/90244/1/apt4983.pd

Effects of baseline abdominal pain and bloating on response to lubiprostone in patients with irritable bowel syndrome with constipation

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/134450/1/apt13807.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/134450/2/apt13807_am.pd

Analysis of Nausea in Clinical Studies of Lubiprostone for the Treatment of Constipation Disorders

BACKGROUND: Lubiprostone is a ClC-2 chloride channel activator approved for the treatment of chronic idiopathic constipation (CIC) and opioid-induced constipation (OIC) in adults and irritable bowel syndrome with constipation (IBS-C) in women. Lubiprostone is generally well tolerated, with nausea being the most common adverse event. AIMS: To characterize nausea with lubiprostone using pooled results from clinical studies in patients with CIC, OIC, or IBS-C. METHODS: Data from three 3- and 4-week placebo-controlled studies and three long-term open-label studies were pooled for the CIC analysis. The OIC and IBS-C analyses each used pooled data from three 12-week placebo-controlled studies and one 36-week open-label extension study. RESULTS: The populations included the following numbers of patients: CIC, 316 (placebo) and 1113 (lubiprostone 24 mcg twice daily [BID]); OIC, 652 (placebo) and 889 (lubiprostone 24 mcg BID); and IBS-C, 435 (placebo) and 1011 (lubiprostone 8 mcg BID). The incidence of nausea in lubiprostone-treated patients ranged from 11.4 to 31.1%, with the highest incidence in patients with CIC. Among patients with any nausea, most reported only mild or moderate severity (96.5-99.1% across indications) and only one event (83.6-88.7%); most events occurred within the first 5 days of treatment. CONCLUSIONS: Nausea was the most common adverse event following the treatment with lubiprostone. Event rates varied by indication and dose, and the majority of nausea adverse events were mild to moderate in severity. Nausea events predominantly occurred early in the treatment period in all of the pooled study populations

A Randomized Comparison of Alternative Formats for Clinical Simulations

Computer-based clinical simulations for medical education vary widely in structure and for mat, yet few studies have examined which formats are optimal for particular educational settings. This study is a randomized comparison of the same simulated case in three formats: a "pedagogic" format offering explicit educational support, a "high-fidelity" format attempting to model clinical reasoning in the real world, and a "problem-solving" format that requires students to express specific diagnostic hypotheses Data were collected from rising third- year medical students using a posttest, attitudinal questionnaire, students' writeups of the case, and log files of students' progress through the simulation. Student performances on all measures differed significantly by format. In general, students using the pedagogic format were more proficient but less efficient. They acquired more information but were able to do proportionately less with it. The results suggest that the format of computer-based simulations is an important educational variable. Key words. medical education, undergraduate; clinical reasoning; computer-assisted instruction. (Med Decis Making 1991;11:265-272

Evaluation of the Birmingham IBS symptom questionnaire

Abstract Background Irritable Bowel Syndrome (IBS) is a chronic/common condition that causes a significant effect on the individual (reduced quality of life), society (time lost off work) and health services. Comparison of studies evaluating the management of IBS has been hindered by the lack of a widely adopted validated symptom score. The aim of this study was to develop and validate a disease specific score to measure the symptoms of patients with IBS. Methods A self-administered 14-item symptom questionnaire (based on Rome II criteria) was mailed to 533 persons included in a prevalence study of IBS. The reliability of each underlying dimension identified was measured by Cronbach's α. Validity was assessed by comparing symptom scores with concurrent IBS specific quality of life (QoL) scores. Reproducibility was measured by the test-retest method and responsiveness measured by effect size. Results 379 (71%) questionnaires were returned. The underlying dimensions identified were pain, diarrhoea and constipation. Cronbach's α was 0.74 for pain, 0.90 for diarrhoea and 0.79 for constipation. Pain and diarrhoea dimensions had good external validity (r = -0.3 to -0.6), constipation dimension had moderate external validity (r = -0.2 to -0.3). All dimensions were reproducible (ICCs 0.75 to 0.81). Effect sizes of 0.27 to 0.53 were calculated for those with a reported improvement in symptoms. Conclusion The Birmingham IBS Symptom Questionnaire has been developed and tested. It has been shown to be suitable for self-completion and acceptable to patients. The questionnaire has 3 internal dimensions which have good reliability, external validity and are responsive to a change in health status.</p

Development and validation of the Patient‐Physician Relationship Scale among patients with irritable bowel syndrome

BackgroundAn effective patient‐physician relationship (PPR) is essential to the care of patients with irritable bowel syndrome (IBS). We sought to develop and validate an IBS‐specific instrument to measure expectations of the PPR.MethodsWe conducted structured focus groups about PPRs with 12 patients with IBS. Qualitative analysis was used to generate a questionnaire (the Patient‐Physician Relationship Scale [PPRS]), which was modified with input from content experts and usability testing. For validation, we administered it online to US adults with IBS. Participants also completed the Functional Bowel Disorder Severity Index, the Rome III Adult Functional gastrointestinal (GI) Disorder Criteria Questionnaire, and modified versions of the Communication Assessment Tool (CAT‐15) and Patient‐Doctor Relationship Questionnaire (PDRQ‐9). We performed principal components factor analysis for the PPRS.Key ResultsThe PPRS contained 32 questions with responses on a 7‐item Likert scale. Themes included interpersonal features, clinical care expectations, and aspects of communication. One thousand and fifty‐four eligible individuals completed the survey (88% completion rate). Most participants were middle aged (mean 48 years, SD 16.3), white (90%), and female (86%). Factor analysis showed only one relevant factor, relating to quality of PPR. The final scale ranged from possible‐96 to +96 (mean 62.0, SD 37.6). It correlated moderately with the CAT‐15 (r=.40, P<.001) and PDRQ‐9 (r=.30, P<.001), establishing concurrent validity.Conclusions & InferencesWe describe the development and validation of the first questionnaire for use in measuring patient expectations of the PPR, which can be used for future outcomes studies and training physicians.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/138227/1/nmo13106.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/138227/2/nmo13106_am.pd

Abuse in Women and Men with and without Functional Gastrointestinal Disorders

We aimed to investigate the history of abuse in childhood and adulthood and health-related quality of life (HRQL) in women and men with FGID in the general adult population. A cross-sectional study in a random population sample (n = 1,537, 20–87 years) living in Östhammar municipality, Sweden, in 1995 was performed. Persons with FGID (n = 141) and a group of abdominal symptom-free controls (SSF, n = 97) were selected by means of a validated questionnaire assessing gastrointestinal symptoms (the ASQ). Abuse, anxiety and depression (the HADS) and HRQL (the PGWB) were measured. Women with FGID had a higher risk of having a history of some kind of abuse, as compared with the SSF controls (45% vs.16%, OR = 2.0, 95% CI: 1.01–3.9; SSF = 1), in contrast to men (29% vs. 24% n.s.). Women with a history of abuse and FGID had reduced HRQL 91 (95% CI 85–97) as compared with women without abuse history 100 (95% CI 96–104, P = 0.01, “healthy” = 102–105 on PGWB). Childhood emotional abuse was a predictor for consulting with OR = 4.20 (95% CI: 1.12–15.7.7). Thus, previous abuse is common in women with FGID and must be considered by the physician for diagnosis and treatment of the disorder

Narcotic use for inflammatory bowel disease and risk factors during hospitalization:

Growing evidence demonstrates adverse effects of narcotics in inflammatory bowel disease (IBD). We sought to study the relationship between narcotic use, objective measures of disease activity and other associated factors in hospitalized patients with IBD

Functional bowel disorders and functional abdominal pain

The Rome diagnostic criteria for the functional bowel disorders and functional abdominal pain are used widely in research and practice. A committee consensus approach, including criticism from multinational expert reviewers, was used to revise the diagnostic criteria and update diagnosis and treatment recommendations, based on research results. The terminology was clarified and the diagnostic criteria and management recommendations were revised. A functional bowel disorder (FBD) is diagnosed by characteristic symptoms for at least 12 weeks during the preceding 12 months in the absence of a structural or biochemical explanation. The irritable bowel syndrome, functional abdominal bloating, functional constipation, and functional diarrhea are distinguished by symptom-based diagnostic criteria. Unspecified FBD lacks criteria for the other FBDs. Diagnostic testing is individualized, depending on patient age, primary symptom characteristics, and other clinical and laboratory features. Functional abdominal pain (FAP) is defined as either the FAP syndrome, which requires at least six months of pain with poor relation to gut function and loss of daily activities, or unspecified FAP, which lacks criteria for the FAP syndrome. An organic cause for the pain must be excluded, but aspects of the patient's pain behavior are of primary importance. Treatment of the FBDs relies upon confident diagnosis, explanation, and reassurance. Diet alteration, drug treatment, and psychotherapy may be beneficial, depending on the symptoms and psychological features.Keywords: functional bowel disorder; functional constipation; functional diarrhea; irritable bowel syndrome; functional abdominal pain; functional abdominal bloating; Rome I