ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS (ABSSSI) SIGNS/ SYMPTOMS AND PROS- A COMPREHENSIVE LITERATURE REVIEW

Author(s)

Cimms TA*1;DeBusk K1;Howard K1;Siuciak JA2;Llorens L3;Crawley J4;Halling K5;The FNIH Biomarkers Consortium CABP ABSSSI Project Team BC6, Powers JH7 1Oxford Outcomes Ltd, an ICON plc Company, San Francisco, CA, USA, 2Foundation for the National Institutes of Health, Bethesda, MD, USA, 3Cerexa, Inc, Oakland, CA, USA, 4AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA, 5AstraZeneca, Mölndal, Sweden, 6The Foundation for the National Institutes of Health, Bethesda, MD, USA, 7National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH), Bethesda, MD, USA

OBJECTIVES: The purpose of this literature review was to investigate existing patient reported outcome (PRO) measures used in studies of acute bacterial skin and skin structure infections (ABSSSI) and to explore signs and symptoms of ABSSSI in order to inform the development of a disease model.  METHODS: To identify relevant abstracts/ articles for inclusion a search was conducted in OVID. For the purpose of this project, MEDLINE (1946 to present) and EMBASE (1988 to 2012) were searched using terms for signs and symptoms and existing PRO measures, specifically related to skin infections. RESULTS: The search identified 299 unique abstracts, of which 276 were excluded based on pre-specified exclusion criteria. The 23 full-text articles obtained were further reviewed for eligibility. The most frequently cited ABSSSI signs/ symptoms were redness of skin/ erythema (n=10), edema (n=7), elevated body temperature (n=7), induration (n=6), pain/ tenderness of the area, expansion of the lesion, demarcated borders, and pus-filled drainage (n=5).  No ABSSSI-specific PROs were identified in this literature review; however, four of the articles reviewed helped inform the development of a disease model.  One study employed qualitative interview methodology to identify perceived sources of infection, and barriers and facilitators to the prevention of CA-MRSA.  Three studies involved ABSSSI-related patient populations and included PRO measures to assess quality of life.  CONCLUSIONS: This literature review confirmed that an ABSSSI-specific PRO measure has not been cited in the literature, and further exploration of ABSSSI signs and symptoms in the form of qualitative interviews with clinicians and patients is needed prior to the development of a relevant PRO measure for this patient population.  The signs and symptoms identified in this literature review informed the development of an ABSSSI disease model, which will be used to help establish the context of use of the new PRO measure.

Conference/Value in Health Info

2013-05, ISPOR 2013, New Orleans, LA, USA

Value in Health, Vol. 16, No. 3 (May 2013)

Code

PRM110

Topic

Economic Evaluation, Methodological & Statistical Research

Topic Subcategory

Cost-comparison, Effectiveness, Utility, Benefit Analysis, PRO & Related Methods

Disease

Infectious Disease (non-vaccine), Sensory System Disorders

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