Lynne Hamm

Clinical trial : asimadoline in the treatment of patients with irritable bowel syndrome

Background  In models of irritable bowel syndrome (IBS), asimadoline, a kappa‐opioid agonist, improves pain and abnormal bowel function.

The effect of the 5-HT3 receptor antagonist, alosetron, on brain responses to visceral stimulation in irritable bowel syndrome patients

Aim : To conduct a placebo‐controlled functional brain imaging study to assess the effect of the 5‐hydroxytryptamine‐3 receptor antagonist, alosetron, on irritable bowel syndrome symptoms, regional brain activation by rectosigmoid distension and associated perceptual and emotional responses.

Use of a novel electronic data collection system in multicenter studies of irritable bowel syndrome.

The reliability of symptom data collected during efficacy studies in irritable bowel syndrome (IBS) is paramount to the proper assessment of potential therapeutic agents. Historically, data have been collected on paper diary cards, which patients were requested to fill out at a specified interval. However, with paper diary cards it is not possible to determine whether the cards are filled out as required, or at random times. To circumvent this problem, a novel electronic data collection system that ensures the reliability and security of data entry was used.

Development and psychometric evaluation of the Bipolar Functional Status Questionnaire (BFSQ)

OBJECTIVES Persistently impaired psychosocial functioning has been recognized in many individuals with bipolar disorder. However, existing measures of functional disability have been adapted for use in bipolar disorder based mainly on those developed for use in other conditions. The present study involved the development and validation of a new patient self-report measure specific to bipolar disorder, the Bipolar Functional Status Questionnaire (BFSQ). METHODS Relevant constructs were identified, evaluated, and refined through an expert advisory panel in conjunction with patient interviews. Questionnaire items were vetted through iterative patient interviews. Psychometric properties were determined based on patient responses from implementation of the proposed 33-item questionnaire in an 11-site study of 596 patients with bipolar disorder across varied phases of illness. RESULTS Eight constructs were identified as fundamental to functional status in bipolar disorder: cognitive function, sleep, role functioning, emotional functioning, energy/vitality, social functioning, personal management, and sexual functioning. Psychometric validation supported item reduction to a 24-item unidimensional scale, with high internal consistency (coefficient alphas = 0.93-0.95), high test-retest reliability (intraclass correlation coefficient = 0.86, 95% confidence interval = 0.82-0.89), strong convergent validity with other functional disability measures (rs > 0.70), and highly significant discriminant validity across illness phases, with large effect sizes (Cohens d > 0.70). CONCLUSIONS The BFSQ is a psychometrically sound self-report measure that can be used to effectively quantify functional status across different clinical states in patients with bipolar disorder.