Jennifer Talley

Is Irritable Bowel Syndrome a Diagnosis of Exclusion?: A Survey of Primary Care Providers, Gastroenterologists, and IBS Experts

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

Development and validation of a novel patient educational booklet to enhance colonoscopy preparation.

297 vs.

Measuring irritable bowel syndrome patient‐reported outcomes with an abdominal pain numeric rating scale

658; P<0.01). Providers who believed IBS is a diagnosis of exclusion ordered 1.6 more tests and consumed

Measuring symptoms in the irritable bowel syndrome: development of a framework for clinical trials

364 more than others (P<0.0001). Experts only rated celiac sprue screening and complete blood count as appropriate in D-IBS; nonexperts rated most tests as appropriate. Parallel results were found in the C-IBS vignette.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.

Development and validation of a disease-targeted quality of life instrument in chronic hepatitis B: The hepatitis B quality of life instrument, version 1.0†‡

OBJECTIVES:The success of colonoscopy depends on high-quality bowel preparation by patients; yet inadequate preparation is common. We developed and tested an educational booklet to improve bowel preparation quality.METHODS:We conducted patient cognitive interviews to identify knowledge and belief barriers to colonoscopy preparation. We used these interviews to create an educational booklet to enhance preparatory behaviors. We then prospectively randomized patients scheduled for outpatient colonoscopy at a VA Medical Center to receive usual instructions vs. the booklet before colonoscopy. Patients in both groups received standard pharmacy instructions for single-dose bowel preparation; the protocol did not specify which purgatives to prescribe. The primary outcome was preparation quality based on blinded ratings using the validated Ottawa score. We performed bivariate analyses to compare mean scores between groups using a t-test, and logistic regression to measure the booklet effect on preparation quality, adjusting for potential confounders.RESULTS:A total of 436 patients were randomized between arms. In an intention-to-treat analysis of the primary outcome, mean Ottawa scores were superior in patients allocated to booklet vs. controls (P=0.03). An intention-to-treat analysis of the secondary outcome revealed a “good” preparation in 68 vs. 46% of booklet and control patients, respectively (P=0.054). In a per-protocol analysis limited to patients who actually received the booklet, preparation was good in 76 vs. 46% patients, respectively (P<0.00001). Regression analysis revealed that booklet receipt increased the odds of good preparation by 3.7 times (95% confidence interval=2.3–5.8).CONCLUSIONS: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.

Developing Valid and Reliable Health Utilities in Irritable Bowel Syndrome: Results from The IBS PROOF Cohort

Background  Controversy 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.

Characterizing abdominal pain in IBS: guidance for study inclusion criteria, outcome measurement and clinical practice

Aliment Pharmacol Ther 2010; 32: 1275–1291

Computer-Generated Vs. Physician-Documented History of Present Illness (HPI): Results of a Blinded Comparison

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. Conclusion: Patients with chronic HBV infection attribute a wide range of negative psychological, social, and physical symptoms to their condition, even in the absence of cirrhosis or cancer. The HBQOL v1.0 is a valid and reliable measure that captures this HRQOL decrement. This instrument may be useful in everyday clinical practice and in future clinical trials. (HEPATOLOGY 2007;46:113–121.)

Development and validation of a disease-targeted quality of life instrument for chronic diverticular disease: the DV-QOL.

OBJECTIVES:A “utility” is a measure of health-related quality of life (HRQOL) that ranges between 0 (death) and 1 (perfect health). Disease-targeted utilities are mandatory to conduct cost–utility analyses. Given the economic and healthcare burden of irritable bowel syndrome (IBS), cost–utility analyses will play an important role in guiding health economic decision-making. To inform future cost–utility analyses in IBS, we measured and validated the IBS utilities.METHODS:We analyzed data from Rome III IBS patients in the Patient Reported Observed Outcomes and Function (PROOF) Cohort—a longitudinal multi-center IBS registry. At entry, the patients completed a multi-attribute utility instrument (EuroQOL), bowel symptom items, IBS severity measurements (IBS Severity Scale (IBSSS), Functional Bowel Disease Severity Index (FBDSI)), HRQOL indexes (IBS quality-of-life instrument (IBS-QOL), Center for disease control-4 (CDC-4)), and the Worker Productivity Activity Index for IBS (WPAI). We repeated assessments at 3 months.RESULTS:There were 257 patients (79% women; age=43±15 years) at baseline and 85 at 3 months. The mean utilities in patients with severe vs. non-severe IBS were 0.70 and 0.80, respectively (P<0.001). There were no differences in utilities among IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), and mixed IBS (IBS-M) subgroups. EuroQOL utilities correlated with FBDSI (r=0.31; P<0.01), IBSSS (r=0.36; P<0.01), IBS-QOL (r=0.36; P<0.01), CDC-4 (r=0.44; P<0.01), WPAI presenteeism (r=0.16; P<0.01), abdominal pain (r=0.43; P<0.01), and distension (r=0.18; P=0.01). The utilities in patients reporting “considerable relief” of symptoms at 3 months vs. those without considerable relief were 0.78 and 0.73, respectively (P=0.02).CONCLUSIONS:EuroQOL utilities are valid and reliable in IBS. The utility of severe IBS (0.7) is similar to Class III congestive heart failure and rheumatoid arthritis. These validated utilities can be employed in future IBS cost–utility analyses.

Dialysis Practices That Distinguish Top- Versus Bottom-Performing Facilities by Hemoglobin Outcomes

Aliment Pharmacol Ther 2010; 32: 1192–1202