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Evidence to Support Unified Symptom Concepts for a Single Patient-Reported Outcome Instrument for Both Community-Acquired and Hospital-Acquired Bacterial Pneumonia
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A5501 - Evidence to Support Unified Symptom Concepts for a Single Patient-Reported Outcome Instrument for Both Community-Acquired and Hospital-Acquired Bacterial Pneumonia
Author Block: J. Powers1, K. Howard2, T. Saretsky3, S. Clifford3, M. Cho3, H. Wang3, S. Hoffmann4, G. Talbot5; 1Medicine, George Washington University School of Medicine, Rockville, MD, United States, 2Medicine, ICON PLC, San Francisco, CA, United States, 3ICON PLC, San Francisco, CA, United States, 4Foundation for the National Institutes of Health, Bethesda, MD, United States, 5Talbot Consulting, Naples, FL, United States.
RATIONALE: Reliable, well-defined, clinically relevant endpoints measuring patient benefits would inform the clinical and regulatory interpretation of clinical trials of community-acquired and hospital-acquired bacterial pneumonia (CABP and HABP, respectively). Specifically, pneumonia symptoms (Sx) and functional impacts (e.g., impairment of activities of daily living) directly recorded by the patient during the course of the treatment intervention are direct measures of treatment effect/ benefit. We hypothesized that although pneumonia is classified by the site at time of onset (community or hospital), Sx of each may be comparable in type, if not severity. Therefore, in the absence of a validated CABP/HABP patient-reported outcome (PRO) instrument, this study was undertaken to identify patient-reported CABP/HABP Sx and impacts, thereby to enable development of a new PRO instrument.
METHODS: Concept elicitation (CE) interviews to ascertain pneumonia Sx/functional impacts were completed by telephone within 10 days of pneumonia diagnosis at US clinical sites, first with CABP, then with HABP, patients. CE data were used to draft questions for a CABP PRO instrument. HABP CE Sx and impacts were evaluated for homology with CABP Sx and impacts to determine whether the CABP item pool could be utilized to develop a single instrument for both diseases. Cognitive debriefing (CD) interviews conducted with both CABP/HABP patients assessed item readability, relevance, comprehensiveness, and content validity of the proposed PRO item pool.
RESULTS: 20 CABP and 19 HABP patients participated in CE interviews. Of 31 Sx spontaneously reported by all patients, 25 were endorsed by both samples. The most common Sx mentioned were problems with breathing, cough, chest pain/hurt, feeling warm/hot, weakness, body aches/pain, and tiredness/lack of energy. All 5 functional impacts reported spontaneously were mentioned by both CABP/HABP patients, the most common being decreased physical and social functioning and impaired activities of daily living. CD data indicated that all patients (n= 9 CABP, n= 11 HABP) interpreted the majority of items on the pneumonia PRO as intended, and found the concepts to be comprehensive and relevant to their illness.
CONCLUSIONS: The extensive overlap in Sx and functional impacts demonstrated for CABP/HABP patients supports the development of a unified, single pneumonia PRO instrument to aid the evaluation of new treatments for both diseases.
Author Block: J. Powers1, K. Howard2, T. Saretsky3, S. Clifford3, M. Cho3, H. Wang3, S. Hoffmann4, G. Talbot5; 1Medicine, George Washington University School of Medicine, Rockville, MD, United States, 2Medicine, ICON PLC, San Francisco, CA, United States, 3ICON PLC, San Francisco, CA, United States, 4Foundation for the National Institutes of Health, Bethesda, MD, United States, 5Talbot Consulting, Naples, FL, United States.
RATIONALE: Reliable, well-defined, clinically relevant endpoints measuring patient benefits would inform the clinical and regulatory interpretation of clinical trials of community-acquired and hospital-acquired bacterial pneumonia (CABP and HABP, respectively). Specifically, pneumonia symptoms (Sx) and functional impacts (e.g., impairment of activities of daily living) directly recorded by the patient during the course of the treatment intervention are direct measures of treatment effect/ benefit. We hypothesized that although pneumonia is classified by the site at time of onset (community or hospital), Sx of each may be comparable in type, if not severity. Therefore, in the absence of a validated CABP/HABP patient-reported outcome (PRO) instrument, this study was undertaken to identify patient-reported CABP/HABP Sx and impacts, thereby to enable development of a new PRO instrument.
METHODS: Concept elicitation (CE) interviews to ascertain pneumonia Sx/functional impacts were completed by telephone within 10 days of pneumonia diagnosis at US clinical sites, first with CABP, then with HABP, patients. CE data were used to draft questions for a CABP PRO instrument. HABP CE Sx and impacts were evaluated for homology with CABP Sx and impacts to determine whether the CABP item pool could be utilized to develop a single instrument for both diseases. Cognitive debriefing (CD) interviews conducted with both CABP/HABP patients assessed item readability, relevance, comprehensiveness, and content validity of the proposed PRO item pool.
RESULTS: 20 CABP and 19 HABP patients participated in CE interviews. Of 31 Sx spontaneously reported by all patients, 25 were endorsed by both samples. The most common Sx mentioned were problems with breathing, cough, chest pain/hurt, feeling warm/hot, weakness, body aches/pain, and tiredness/lack of energy. All 5 functional impacts reported spontaneously were mentioned by both CABP/HABP patients, the most common being decreased physical and social functioning and impaired activities of daily living. CD data indicated that all patients (n= 9 CABP, n= 11 HABP) interpreted the majority of items on the pneumonia PRO as intended, and found the concepts to be comprehensive and relevant to their illness.
CONCLUSIONS: The extensive overlap in Sx and functional impacts demonstrated for CABP/HABP patients supports the development of a unified, single pneumonia PRO instrument to aid the evaluation of new treatments for both diseases.
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