{"content":[{"text":"Clinical Outcome Assessments (COA) Qualification Program \n DDT COA #000018: Pneumonia Patient-Reported Outcome Measure \n (PNEUMO-PRO) \n June 6, 2018 Update","bbox":{"left":0.162569,"top":0.10619,"width":0.6751130000000001,"height":0.08545499999999998}},{"text":"DDT # 0018 \n June 5, 2018","bbox":{"left":0.117647,"top":0.239663,"width":0.099804,"height":0.03681400000000004}},{"text":"The CABP instrument has been formally renamed as PNEUMO-PRO© 2017 Foundation for the \n National Institutes of Health.","bbox":{"left":0.117647,"top":0.290693,"width":0.7109510000000001,"height":0.03412400000000004}},{"text":"Along with the inclusion of the HABP-specific criteria, we have been made modifications based on the \n feedback we received from sites about the difficulty of enrolling patients: \n • A footnote has been added to the fever criteria, in order to allow for “self-reported history of \n fever.” Sites have reported that patients may have had a fever before being admitted, but the \n current criteria does not allow for this to be considered an eligible sign/symptom. \n • Expansion of the enrollment window from 24 hours to 48 hours after treatment initiation: \n This decision has been made after multiple conversations with the clinicians and site coordinators \n participating in the validation studies as well as the expert opinion leaders on the FNIH Project \n team. The narrow window of 24 hours has made it extremely difficult to recruit patients due to \n the time window of their availability, especially during weekend hours (i.e. admitted on Fri/Sat). \n We continue to reiterate to sites that they should be enrolling patients as soon as possible; \n furthermore, during data analysis, we will have the ability to stratify to compare patients who \n were enrolled 24 hrs vs. 48 hours post treatment initiation.","bbox":{"left":0.117651,"top":0.337139,"width":0.7612319999999999,"height":0.21236700000000003}},{"text":"The contract provides for a step-wise approach for the psychometric evaluation of the content validated \n instruments and our Team supports that the change to enrolment criteria will not affect the objective of \n psychometric validation since we are validating the measures prior to evaluating drug effectiveness. This \n dual approach seeks to spur standardized and harmonized use of the instruments by sponsor as the efforts \n move along the qualification process","bbox":{"left":0.117669,"top":0.562721,"width":0.756821,"height":0.08252099999999996}},{"text":"CABP PRO and Protocol Comments: \n 1. CABP PRO Items: While we agree that it is acceptable to proceed with the full 29-item CABP \n PRO diary in your psychometric evaluation study at this time, note that you will need to submit a \n copy of your psychometric study report, along with a full data set (including longitudinal item \n response data from each participant, baseline information, and other measures completed by \n participants and clinicians) to facilitate qualification review. We remind you that we are most \n interested in core disease-related symptoms and impacts, as outlined in the CABP guidance. \n Careful attention to content validity and other measurement properties of the instrument and \n adherence to the agreed upon concept(s) and context of use for the instrument will be needed for \n successful qualification effort. Retention of items that do not closely adhere to the concept(s) \n could present a content validity issue.","bbox":{"left":0.117647,"top":0.659084,"width":0.7578040000000001,"height":0.177832}},{"text":"Response: We will submit a copy of our full psychometric evaluation study report to \n facilitate the qualification review.","bbox":{"left":0.176463,"top":0.850716,"width":0.644707,"height":0.03521099999999999}}],"images_bbox":[],"images_bbox_not_text_overlap":[]}