EVALUATION OF THE PERFORMANCE PROPERTIES OF THE INFLUENZA PATIENT-REPORTED OUTCOMES INSTRUMENT (FLU-PRO) IN PATIENTS WITH INFLUENZA-LIKE ILLNESS (ILI)

Author(s)

Powers J¹, Bacci ED², Leidy NK³, Stringer S³, Memoli MJ⁴, Han A⁴, Fairchok MP⁵, Coles C⁶, Owens J⁶, Chen W⁷, Arnold JC⁸, Danaher PJ⁹, Lalani T¹⁰, Hansen EA¹¹, Burgess TH⁷, Millar EV⁷, Hernández A¹², Rodríguez-Zulueta P¹³, Ortega-Gallegos H¹⁴, Galindo-Fraga A¹⁵, Ruiz-Palacios GM¹⁴, Pett S¹⁶, Fischer W¹⁷, Gillor D¹⁸, Macias LM¹⁹, DuVal A²⁰, Rothman R²⁰, Dugas A²⁰, Guerrero ML¹⁵
¹Division of Clinical Research, NIAID, NIH, Rockville, MD, USA, ²Evidera, Seattle, MD, USA, ³Evidera, Bethesda, MD, USA, ⁴National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA, ⁵Madigan Army Medical Center; Infectious Disease Clinical Research Program, Uniformed Services University, Tacoma, WA, USA, ⁶Uniformed Services University, Bethesda, MD, USA, ⁷Infectious Disease Clinical Research Program, Uniformed Services University, Rockville, MD, USA, ⁸Naval Medical Center, San Diego, CA, USA, ⁹Air Force Medical Operations Agency (AFMOA), Lackland, TX, USA, ¹⁰Naval Medical Center, Portsmouth, VA, USA, ¹¹Naval Health Research Center, San Diego, CA, USA, ¹²Instituto Nacional de Enfermedades Respiratorias, Ciudad de México, Mexico, ¹³Hospital General Dr. Manuel Gea González, Ciudad de México, Mexico, ¹⁴Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico, ¹⁵Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran, Ciudad de Mexico, Mexico, ¹⁶University College London, London, UK, ¹⁷University of North Carolina, Chapel Hill, NC, USA, ¹⁸University Hospital of Cologne, Köln, Germany, ¹⁹Hospital General de Agudos JM Ramos Mejia Servicio de Inmunocomprometidos, Buenos Aires, Argentina, ²⁰Johns Hopkins University School of Medicine, Baltimore, MD, USA

OBJECTIVES: Test the reliability, validity, and responsiveness of the FLU-PRO for evaluating presence and severity of symptoms in adults with influenza-like illness (ILI). METHODS: Analyses of data from subjects testing influenza-negative participating in the prospective, observational study used to develop and evaluate the FLU-PRO. Adults (≥18 years with ILI) were recruited through outpatient settings in the US, UK, Mexico, Peru, and Argentina, and completed the 37-item draft FLU-PRO daily for up to 14-days. Laboratory tests confirmed the presence/absence of influenza. The performance of the final 32-item FLU-PRO, developed and validated with data from influenza-positive subjects, was tested. The FLU-PRO assesses signs/symptoms across six body systems: Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal, Body/Systemic. Reliability was estimated using Cronbach’s alpha (α; Day 1) and intraclass correlation coefficients (ICC; 2-day reproducibility). Convergent and known-groups validity were assessed using patient global assessments of symptom severity (PGA; none, mild, moderate, severe, very severe). Patient report of return to usual health was used to assess responsiveness (Day 1-7). RESULTS: N=220 ILI patients, mean age=39.3, 64.1% female, 88.6% white. N=61 (28%) were hospitalized at some point in their illness. Reliability: α Total score = 0.90; α subscales = 0.72 to 0.86; ICC (Day 1-2) Total score = 0.64; ICC subscales= 0.46 to 0.78. At Day 1, FLU-PRO scores correlated (≥0.30) with the PGA (except Gastrointestinal). FLU-PRO scores were significantly different across PGA severity groups (Total: F=81.7, p<0.001; subscales: F=6.9-62.2; p<0.01). Mean improvement in FLU-PRO scores from Day 1 to 7 was significantly greater in patients reporting return to usual health compared with those who did not (p<0.05 for Total and all subscales, expect Gastrointestinal and Eyes). CONCLUSIONS: Results suggest FLU-PRO total and domain scores are reliable, valid, and responsive in studies of adults with ILI, with or without documented influenza virus infection.

Conference/Value in Health Info

2017-05, ISPOR 2017, Boston, MA, USA

Value in Health, Vol. 20, No. 5 (May 2017)

Code

PIN51

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Infectious Disease (non-vaccine)

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