OBJECTIVES-Guidelines emphasize that irritable bowel syndrome (IBS) is not a diagnosis of exclusion and encourage clinicians to make a positive diagnosis using the Rome criteria alone. Yet many clinicians are concerned about overlooking alternative diagnoses. We measured beliefs about whether IBS is a diagnosis of exclusion, and measured testing proclivity between IBS experts and community providers.METHODS-We developed a survey to measure decision-making in two standardized patients with Rome III-positive IBS, including IBS with diarrhea (D-IBS) and IBS with constipation (C-IBS). The survey elicited provider knowledge and beliefs about IBS, including testing proclivity and beliefs regarding IBS as a diagnosis of exclusion. We surveyed nurse practitioners, primary care physicians, community gastroenterologists, and IBS experts.RESULTS-Experts were less likely than nonexperts to endorse IBS as a diagnosis of exclusion (8 vs. 72%; P < 0.0001). In the D-IBS vignette, experts were more likely to make a positive diagnosis of IBS (67 vs. 38%; P < 0.001), to perform fewer tests (2.0 vs. 4.1; P < 0.01), and to expend less money on testing (US$297 vs. $658; P < 0.01). Providers who believed IBS is a diagnosis of exclusion ordered 1.6 more tests and consumed $364 more than others (P < 0.0001). Experts only rated celiac CONFLICT OF INTERESTGuarantor of the article: Brennan M.R. Spiegel, MD, MSHS. Specific author contributions: Study design, study implementation, data collection, data analysis, data interpretation, paper preparation, and paper approval: Brennan Spiegel; study design, study implementation, data collection, and paper review: Mary Farid; study design, data interpretation, and paper review: Eric Esrailian; study implementation and data collection: Jennifer Talley; study design, data interpretation, paper preparation, and paper approval: Lin Chang. Potential competing interests: Spiegel and Chang have served as advisors to Prometheus Laboratories, and have received grant support from Takeda Sucampo Pharmaceuticals, Rose Pharmaceuticals, and Prometheus Laboratories. NIH Public Access Author ManuscriptAm J Gastroenterol. Author manuscript; available in PMC 2010 October 4. CONCLUSIONS-Most community providers believe IBS is a diagnosis of exclusion; this belief is associated with increased resource use. Experts comply more closely with guidelines to diagnose IBS with minimal testing. This disconnect suggests that better implementation of guidelines is warranted to minimize variation and improve cost-effectiveness of care.

Provision of a novel educational booklet considerably improves preparation quality in patients receiving single-dose purgatives. The effect of the booklet on split-dose purgatives remains untested and will be evaluated in future research.

SUMMARY BackgroundControversy exists on how to measure patient-reported outcomes in irritable bowel syndrome (IBS) clinical trials effectively. Pain numeric rating scales (NRS) are widely used in the non-IBS pain literature. The Food and Drug Administration has proposed using the NRS in IBS.

SUMMARY BackgroundThere is uncertainty about how to measure patient-reported outcomes (PROs) in IBS. The Food and Drug Administration (FDA) emphasizes that PROs must be couched in a conceptual framework, yet existing IBS PROs were not based on such a framework.

Despite the increasing realization that health-related quality of life (HRQOL) is an important outcome in chronic HBV infection, there are no validated, disease-targeted instruments currently available. We sought to develop and validate the first disease-targeted HRQOL instrument in noncirrhotic HBV: the Hepatitis B Quality of Life instrument, version 1.0 (HBQOL v1.0). We established content validity for the HBQOL v1.0 by conducting a systematic literature review, an expert focus group, and cognitive interviews with HBV patients. We administered the resultant questionnaire to 138 HBV patients. We used factor analysis to test hypotheses regarding HRQOL domains and measured construct validity by comparing HBQOL v1.0 scores across several anchors, including viral response to treatment, SF-36 scores, and global health. Finally, we measured test-retest and internal consistency reliability. Content validation revealed that HBV affects multiple aspects of psychological, social, and physical health. The resultant questionnaire summarized this HRQOL impact with 31 items across six subscales: psychological well-being, anticipation anxiety, vitality, disease stigma, vulnerability, and transmissibility. Internal consistency and test-retest reliability were excellent. The HBQOL v1.0 discriminated between viral responders versus nonresponders and correlated highly with SF-36 scores and global health. C hronic HBV infection is a prevalent and expensive condition affecting 350 million people worldwide and 1.25 million in the United States 1 at a cost of over $700 million annually. 2 HBV leads to cirrhosis in up to 20% of those chronically infected and is a one of the most common indications for liver transplantation worldwide. 1 This economic burden is compounded by the significant impact of HBV on health- Research and Education. Received September 11, 2006; accepted January 24, 2007. Supported by Veterans Administration Health Services Research & Development Research Career Development Award RCD 03-179-2 (B.M.R.S.), Research and Education (CORE), CURE Digestive Diseases Research Center, 11301 Wilshire Boulevard, Building 115, Room 215, Los Angeles, CA 90073. E-mail: bspiegel@mednet.ucla.edu; fax: 310-268-4510; or: Fasiha Kanwal, M.D., M.S.H.S., at fkanwal@yahoo.com. Copyright © 2007 There is currently a disconnect between the increasing realization that HRQOL is an important outcome in chronic diseases such as HBV and the scarcity of diseasetargeted instruments to measure HRQOL in chronic HBV. In the absence of a validated, disease-targeted measure of HRQOL in HBV, investigators and clinicians must rely on either generic HRQOL measurements or traditional biological outcomes to assess their patients' health status. However, generic HRQOL measurements may fail to capture the most important components of HRQOL in HBV, and traditional biological outcomes fail to acknowledge the patients' perception of their disease. Therefore, the current menu of available patientoriented outcomes in HBV is limited.In light of this shortc...