EVALUATION OF THE PERFORMANCE PROPERTIES OF THE INFLUENZA PATIENT-REPORTED OUTCOMES INSTRUMENT (FLU-PRO)

Author(s)

Powers JH¹, Bacci ED², Leidy NK³, Stringer S³, Kim K³, Memoli MJ⁴, Han A⁴, Fairchok MP⁵, Chen W⁶, Arnold JC⁷, Danaher PJ⁸, Lalani T⁹, Hansen EA¹⁰, Ridore M¹¹, Burgess TH⁶, Millar EV⁶, Hernández A¹², Rodríguez-Zulueta P¹³, Ortega-Gallegos H¹⁴, Galindo-Fraga A¹⁴, Ruiz-Palacios GM¹⁴, Pett S¹⁵, Fischer W¹⁶, Gillor D¹⁷, Macias LM¹⁸, DuVal A¹⁹, Rothman R¹⁹, Dugas A¹⁹, Guerrero ML¹⁴
¹Leidos Biomedical Research in support of NIH, George Washington University School of Medicine, Rockville, MD, USA, ²Evidera, Seattle, WA, 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, ⁶Infectious Disease Clinical Research Program, Uniformed Services University, Rockville, MD, USA, ⁷Naval Medical Center, San Diego, CA, USA, ⁸Air Force Medical Operations Agency (AFMOA), Lackland, TX, USA, ⁹Naval Medical Center Portsmouth, VA; Infectious Disease Clinical Research Program, Uniformed Services University, Portsmouth, VA, USA, ¹⁰Operational Infectious Diseases, Naval Health Research Center, San Diego, CA, USA, ¹¹Children’s National Medical Center, Washington, DC, 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 Zubiran, Ciudad de Mexico, Mexico, ¹⁵University College London, London, UK, ¹⁶The University of North Carolina School of Medicine, Chapel Hill, NC, USA, ¹⁷University Hospital of Cologne, Köln, Germany, ¹⁸Hospital General de Agudos JM Ramos Mejia Servicio de Inmunocomprometidos, Buenos Aires, Argentina, ¹⁹Johns Hopkins University School of Medicine, Baltimore, MD, USA

Presentation Documents

PIN52--strong-u-powers-jh-u-sup-1-sup-strong-bacci-ed-sup-2-sup-leidy-nk-sup-3-sup-stringer-s-sup-3-sup-kim-k-sup-3-sup-memoli-mj-sup-4-sup-han-a-sup-4-sup-fairchok-mp-sup-5-sup-chen-w-sup-6-sup-arnold-jc-sup-7-sup-danaher-pj-sup-8-sup-lala ...

OBJECTIVES: Evaluate the reliability, validity, and responsiveness of the FLU-PRO for evaluating presence and severity of symptoms in adults with influenza. METHODS: Prospective, observational study of adults (≥18 years) with influenza-like illness. Subjects were recruited through clinics in the US, UK, Mexico, and South America and completed the 37-item draft FLU-PRO daily for up to 14 days. Item-level distributional characteristics and factor analyses were used to determine the factor structure and remove redundant/misfitting items. Reliability of the final domain and total scale scores was estimated using Cronbach’s alpha and intraclass correlation coefficients (ICC; 2-day reproducibility). Convergent and known-groups validity was assessed using global assessments related to influenza severity. Patient return to usual health was used to assess responsiveness from Day 1–7. RESULTS: N=221 laboratory-confirmed influenza, mean age=40.7, 60.2% female, 59.7% white. The final model was a 6-factor structure: (Nose [4-item], Throat [3-item], Eyes [3-item], Chest/Respiratory [7-item], Gastrointestinal [4-item], and Body/Systemic [11-item], with a higher-order factor representing symptom severity (comparative fit index [CFI]=0.92; root mean square error of approximation [RMSEA]=0.06). Cronbach’s alpha was high for the total (0.92) and domains (range=0.71–0.87); test-retest reliability (Day 1–2) was ICC=0.83 for the total and ranged from 0.57 to 0.79 for domains. At Day 1, FLU-PRO domain and total scores were moderately-to-highly correlated (≥0.30) with Patient Global Rating of Flu Severity (except Nose, Throat). Known-groups validity was supported for the total (F=57.2, p<0.001) and domains (F=8.9–67.5, p<0.001). For the total and all domains (except Gastrointestinal), patients that returned to usual health reported significantly greater (p<0.05) improvement at Day 7 than patients that did not return to usual health. CONCLUSIONS: FLU-PRO assesses the presence and severity of 32 signs and symptoms of influenza covering 6 body systems. This study suggests FLU-PRO scores are reliable, valid, and responsive to change in adults with acute influenza.

Conference/Value in Health Info

2016-05, ISPOR 2016, Washington DC, USA

Value in Health, Vol. 19, No. 3 (May 2016)

Code

PIN52

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Infectious Disease (non-vaccine)

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