{"content":[{"text":"2.","bbox":{"left":0.147059,"top":0.088807,"width":0.013529000000000013,"height":0.018595}},{"text":"Not Applicable Response Option: You have chosen to retain the “Not Applicable” response \n option for items 24-29 (see FDA letter of August 17, 2017) and have requested clarification \n regarding our recommendation. \n a. To clarify, we continue to recommend the removal of the “Not Applicable” options from \n items 24-29. We do not believe that “Not Applicable” is a meaningful response to these \n items. \n i. Response: We have complied with your recommendation and removed the \n “Not Applicable” option. \n b. The Rating Scale model and classical test theory scoring you will use in your \n psychometric analysis assume that items have ordinal response scales. The CABP PRO’s \n first 23 items have a 5-point ordinal response scale (from “Not at all” to “Very Much”) \n but items 24-29 do not have an ordinal response scale due to the inclusion of the “Not \n Applicable” option. Please explain how your IRT and classical test theory scoring will \n accommodate item responses of “Not Applicable.”","bbox":{"left":0.176463,"top":0.088807,"width":0.699811,"height":0.22613800000000003}},{"text":"Response: The “Not Applicable” response options have been removed.","bbox":{"left":0.235289,"top":0.328745,"width":0.539012,"height":0.01930599999999999}},{"text":"c.","bbox":{"left":0.205867,"top":0.360276,"width":0.01255500000000001,"height":0.018594999999999973}},{"text":"Please provide us with a rationale, supported by the qualitative interview data (patient \n understanding of this option within the context of each question), to justify the inclusion \n of the “Not Applicable” option for items 24-29. We continue to have concerns that \n patients might have difficulty interpreting the meaning of the “Not Applicable” response \n option for items 24-29.","bbox":{"left":0.235289,"top":0.360276,"width":0.637618,"height":0.08252100000000001}},{"text":"Response: The “Not Applicable” response options have been removed.","bbox":{"left":0.235289,"top":0.456444,"width":0.539061,"height":0.01930599999999999}},{"text":"3.","bbox":{"left":0.147059,"top":0.487989,"width":0.013529000000000013,"height":0.018595000000000028}},{"text":"Item Interpretation for Inpatients vs. Outpatients: We continue to have concerns regarding \n the interpretation of items 24 (difficulty sleeping), 25 (difficulty doing usual activities), and 27 \n (social activities) among inpatients and outpatients (see FDA letter of August 17, 2017). \n Specifically, we are concerned that inpatients’ responses to these items could be limited by \n hospital protocol/ environment (e.g., level of independence and sleep schedules) whereas \n outpatients don’t have these same constraints. Please explain how your scoring algorithm will \n account for these differences between the two subpopulations.","bbox":{"left":0.176463,"top":0.487989,"width":0.681568,"height":0.11448400000000003}},{"text":"Response: This is precisely why we initially wanted to include the N/A response options for \n specific items which cannot be responded to appropriately by inpatients. For our planned \n analyses, we should first explore if the items do indeed perform differently in inpatients vs. \n outpatients. We can do this by exploring, in IRT, whether the items show any differential \n item functioning (DIF). If DIF is found, then an appropriate scoring algorithm could be \n used to rescore inpatients item scores. For example, items could be rescored to reflect item \n scores reported by outpatients with similar level of difficulties in other items.","bbox":{"left":0.176463,"top":0.61612,"width":0.694315,"height":0.11519500000000005}},{"text":"4.","bbox":{"left":0.147059,"top":0.743439,"width":0.014705999999999997,"height":0.020212000000000008}},{"text":"Item Skipping: We understand that the ePRO device used at US sites will be \n programmed to require participants to respond to every item. \n a. We are concerned that forcing patients to respond to each of the 29 items will add \n undue patient burden, increase chances for fatigue, and consequently impact the \n quality of response received over the 14-day period. That is, valid item responses \n will be discarded if a patient decides not to complete the entire PRO, and other \n fatigued patients will sometimes give rote responses to hasten completion. Please \n explain your plan for empirically evaluating the effect of response requirements \n on the quality, validity and reliability of the CABP PRO data. If evidence in the","bbox":{"left":0.176471,"top":0.743439,"width":0.7007810000000001,"height":0.15960600000000003}}],"images_bbox":[],"images_bbox_not_text_overlap":[]}