SIGNS, SYMPTOMS, AND EXISTING PATIENT-REPORTED OUTCOME (PRO) MEASURES IN HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA (HABP)- A COMPREHENSIVE LITERATURE REVIEW

Author(s)

Saretsky T1, Clifford S1, Hoffmann SC2, Powers JH3, Talbot GH4, Howard K1
1ICON Clinical Research, LLC, San Francisco, CA, USA, 2Foundation for the National Institutes of Health, Bethesda, MD, USA, 3Leidos Biomedical Research, Inc., North Bethesda, MD, USA, 4Talbot Advisors, LLC, Anna Maria, FL, USA

OBJECTIVES: Standardized methods to measure symptoms and related patient-reported outcomes (PRO) in Hospital-Acquired Bacterial Pneumonia (HABP) are limited. The purpose of this literature review was to identify signs, symptoms, and measurement tools associated with patients’ experience of HABP. The results will be used to inform the development of a valid PRO tool for HABP that is consistent with the FDA PRO Guidance.  METHODS: To identify relevant literature, MEDLINE (1946 to 2014) and EMBASE (1988 to 2014) databases were searched individually and in combination using terms related to Hospital-Acquired Pneumonia (HAP), HABP, signs and symptoms, and patient-reported outcomes. RESULTS: The search identified 1384 abstracts. 225 were excluded as duplicates or for missing content. 1145 abstracts were excluded based on pre-specified criteria. The remaining articles were scrutinized for eligibility, resulting in six that met the inclusion criteria. The most frequently cited signs and symptoms of HABP were fever, cough, purulent sputum, dyspnea, rales, chest pain, and elevated respiratory rate. No PRO measures for assessing HABP signs and symptoms were identified in the literature. Current HABP clinical trials have not included end points that directly measure how a patient feels and functions. CONCLUSIONS: The HABP literature has historically focused on clinical outcomes to evaluate treatment efficacy and there is currently limited evidence assessing the impact of antibiotic therapies on symptomatology in HABP patients. Endpoints, such as clinical response, clinical cure, and time to event, are only indirect measures of treatment benefit and have not been validated. It is essential to develop reliable, well-defined and clinically relevant endpoints that measure tangible benefits for patients in clinical trials of antibacterial drugs in accordance with the FDA Guidance for PRO measures and HABP. This literature review is the first step in identifying concepts that will be explored further in qualitative interviews with HABP patients.

Conference/Value in Health Info

2015-05, ISPOR 2015, Philadelphia, PA, USA

Value in Health, Vol. 18, No. 3 (May 2015)

Code

PIN86

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Infectious Disease (non-vaccine)

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