Evidence map›Paper›PMID 29566007›Full record

Observational studyPloS one2018

Performance of the inFLUenza Patient-Reported Outcome (FLU-PRO) diary in patients with influenza-like illness (ILI).

John H Powers, Elizabeth D Bacci, Nancy K Leidy, Jiat-Ling Poon, Sonja Stringer, Matthew J Memoli, Alison Han, Mary P Fairchok, Christian Coles, Jackie Owens and 20 more

Open access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 3 pooled it
11.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 3 syntheses or guidelines pooled it, 67 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Safety and Efficacy of CR6261 in an Influenza A H1N1 Healthy Human Challenge Model.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Trial
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  10. Article
  11. Observational
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  14. Health-related Quality of Life in European Older Adults with Respiratory Syncytial Virus Over Three Respiratory Syncytial Virus Seasons.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  15. Article
  16. Article
  17. Patient-Reported Outcomes and Health-Related Quality-of-Life Measures in Infectious Diseases Studies and Clinical Practice.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

30 authors at 16 institutions in 6 countries.

John H PowersClinical Research Directorate/Clinical Monitoring Research Program, Leidos Biomedical Research, Inc., NCI Campus at Frederick, Frederick, MD, United States of America.ORCID 0000-0002-5150-5119
Elizabeth D BacciEvidera Evidence, Value & Access by PPD, Seattle, WA, United States of America.
Nancy K LeidyEvidera Evidence, Value & Access by PPD, Bethesda, MD, United States of America.
Jiat-Ling PoonEvidera Evidence, Value & Access by PPD, Bethesda, MD, United States of America.
Sonja StringerEvidera Evidence, Value & Access by PPD, Bethesda, MD, United States of America.
Matthew J MemoliNational Institutes of Allergy and Infectious Diseases, NIH, Bethesda, MD, United States of America.
Alison HanNational Institutes of Allergy and Infectious Diseases, NIH, Bethesda, MD, United States of America.
Mary P FairchokMadigan Army Medical Center, Fort Lewis, WA, United States of America.
Christian ColesInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University, Bethesda, MD, United States of America.
Jackie OwensInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University, Bethesda, MD, United States of America.
Wei-Ju ChenInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University, Bethesda, MD, United States of America.
John C ArnoldNaval Medical Center, San Diego, CA, United States of America.
Patrick J DanaherDefense Institute for Medical Operations, San Antonio, TX, United States of America.
Tahaniyat LalaniHenry M. Jackson Foundation for the Advancement of Military Medicine, Rockville, MD, United States of America.
Timothy H BurgessInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University, Bethesda, MD, United States of America.
Eugene V MillarInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University, Bethesda, MD, United States of America.
Michelande RidoreChildren's National Medical Center, Washington, DC, United States of America.
Andrés HernándezInstituto Nacional de Enfermedades Infecciosas, Mexico City, Mexico.
Patricia Rodríguez-ZuluetaHospital General Dr. Manuel Gea González, Mexico City, Mexico.
Hilda Ortega-GallegosInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Arturo Galindo-FragaInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Guillermo M Ruiz-PalaciosInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Sarah PettUCL, London, United Kingdom.
William FischerINSIGHT Influenza Study Groups, Rochester, MN, United States of America.
Daniel GillorINSIGHT Influenza Study Groups, Rochester, MN, United States of America.
Laura Moreno MaciasINSIGHT Influenza Study Groups, Rochester, MN, United States of America.
Anna DuValJohns Hopkins University School of Medicine, Baltimore, MD, United States of America.
Richard RothmanJohns Hopkins University School of Medicine, Baltimore, MD, United States of America.
Andrea DugasJohns Hopkins University School of Medicine, Baltimore, MD, United States of America.
M Lourdes GuerreroInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Henry M. Jackson Foundation · USInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán · MXAccess to Wholistic and Productive Living Institute · USJohns Hopkins University · USNational Institute of Allergy and Infectious Diseases · USChildren's National · USHospital General Dr. Manuel Gea Gonzalez · MXHospital Ramos Mejía · ARInstituto Nacional de Enfermedades Respiratorias · MXIthaka Harbors · USLeidos (United States) · USNaval Medical Center San Diego · USUniformed Services University of the Health Sciences · USUniversity of Cologne · DEUniversity of North Carolina at Chapel Hill · USUNSW Sydney · AU

Funding

Pandemic Influenza Translational Research; Novel Vaccine and Drug TherapyZIAAI001157 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI MEMOLI, MATTHEW · 2012 to 2025
$37.2M
CCR NIH HHS HHSN261200800001CMedical Research Council MC_UU_12023/22NCI NIH HHS HHSN261200800001E
6 · The paper itself

Abstract

backgroundThe inFLUenza Patient Reported Outcome (FLU-PRO) measure is a daily diary assessing signs/symptoms of influenza across six body systems: Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal, Body/Systemic, developed and tested in adults with influenza.

objectivesThis study tested the reliability, validity, and responsiveness of FLU-PRO scores in adults with influenza-like illness (ILI).

methodsData from the prospective, observational study used to develop and test the FLU-PRO in influenza virus positive patients were analyzed. Adults (≥18 years) presenting with influenza symptoms in outpatient settings in the US, UK, Mexico, and South America were enrolled, tested for influenza virus, and asked to complete the 37-item draft FLU-PRO daily for up to 14-days. Analyses were performed on data from patients testing negative. Reliability of the final, 32-item FLU-PRO 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 influenza severity (PGA). Patient report of return to usual health was used to assess responsiveness (Day 1-7).

resultsThe analytical sample included 220 ILI patients (mean age = 39.3, 64.1% female, 88.6% white). Sixty-one (28%) were hospitalized at some point in their illness. Internal consistency reliability (α) of FLU-PRO Total score was 0.90 and ranged from 0.72-0.86 for domain scores. Reproducibility (Day 1-2) was 0.64 for Total, ranging from 0.46-0.78 for domain scores. Day 1 FLU-PRO scores correlated (≥0.30) with the PGA (except Gastrointestinal) and were significantly different across PGA severity groups (Total: F = 81.7, p<0.001; subscales: F = 6.9-62.2; p<0.01). Mean score improvements Day 1-7 were significantly greater in patients reporting return to usual health compared with those who did not (p<0.05, Total and subscales, except Gastrointestinal and Eyes).

conclusionsResults suggest FLU-PRO scores are reliable, valid, and responsive in adults with influenza-like illness.

Indexed as

Medical RecordsSelf ReportAdultAgedAged, 80 and overFemaleHumansInfluenza, HumanMaleMiddle AgedProspective Studies

Identifiers

PMID29566007
PMCPMC5863969
OpenAlexW2793922718

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.