Physicians' beliefs about efficacy in subgroups of CD patients, safety, and patient preferences primarily motivate aminosalicylate prescription in CD. There is a lack of confidence in published clinical trials, and a desire for more robust evidence to inform 5-ASA use in CD.

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A41what administration intervals are used in the development and validation of PROs, as a first step towards ascertaining the most appropriate interval between administrations for test-retest and equivalence studies for different measures. METHODS: A literature review was conducted using the following search terms: test retest reliability, equivalence testing, washout period, and interval on Psychinfo since January 2003. 554 abstracts were identified. Thirty-two additional abstracts from an equivalence study review paper were included resulting in a total of 586 abstracts. All abstracts were reviewed and where available the administration interval was extracted and collated. RESULTS: One percent of the test retest studies had an interval of one hour or less, 18% had an interval of 1 day to 1 week, 25% had an interval of 1weeks to 2 weeks, 21% had an interval of 2 weeks to 1 month, 9% had an interval of 1 to 2 month, 13 % had an interval of 2 months or over, 13% reported a varied interval. In contrast, 50% of the equivalence studies had an administration interval of 1 hour or less, 9% had an interval of 1 hour to 1 day, 28% had an interval of 1 day to 1 week, 3% an interval of 1 to 2 weeks 10% reported a varied interval within the same study. CONCLUSIONS: There is a wide variety of administration intervals used in testretest and equivalence studies seen within the literature. Considerations around the appropriate administration interval to use should be based on, amongst other things, an assessment of the stability of the condition involved and the complexity of the PRO.

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To evaluate the content, clarity, and relevance of a new patientreported outcome questionnaire, the Alopecia Patient Assessment (APA), among women with breast cancer and alopecia. METHODS: 10 US subjects were recruited from oncology practices, breast cancer support websites, and other online sources, and asked to complete the APA, a five-item questionnaire assessing impact of hair loss on spending time with family/friends (Item #1), work (Item #2), ability to leave home (Item #3), self-image (Item #4), and feelings of embarrassment (Item #5). Subjects also completed a telephone interview about the APA. RESULTS: Mean age = 52 + 11 years (50% Caucasian, 60% married). All respondents felt the instructions were clear. Some suggestions included defining "hair loss" to include currently losing or already lost some or all of your hair, and to add instructions about how to respond if you typically wear a wig, hat or wrap. 90% found the questionnaire to be clear, with 70% reporting it was "very easy" to complete. One hundred percent correctly paraphrased the first 3 items, while 60% and 89% (8/9) correctly paraphrased Items 4 and 5, respectively. All respondents stated the 5 response options ("not at all" to "very much") were clear. Although 78% (7/9) felt it was easy to recall "the past week," 60% thought it would be clearer to use "the past 7 days." Thirty percent were uncertain how to respond to Item #2, as they weren't currently employed. Minor modifications included adding more general instructions for completion, using the past 7 days for the recall period, and adding a check box for Item #2 for those not employed. CONCLUSIONS: In general, the APA was clear, comprehensive, and relevant among breast cancer patients with alopecia. The APA can be considered for clinical trials to determine the patient perspective of this important symptom associated with chemotherapy.