Development of the Flu-PRO: a patient-reported outcome (PRO) instrument to evaluate symptoms of influenza

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• 作者：John H. Powers ; M. Lourdes Guerrero ; Nancy Kline Leidy…
• 关键词：Influenza ; Symptoms ; Patient ; reported outcomes ; Endpoints ; Outcome assessments ; Content validity
• 刊名：BMC Infectious Diseases
• 出版年：2016
• 出版时间：December 2016
• 年：2016
• 卷：16
• 期：1
• 全文大小：582 KB
• 参考文献：1.Centers for Disease Control and Prevention (CDC): Seasonal Influenza (Flu). http://​www.​cdc.​gov/​flu/​about/​disease/​index.​htm . Accessed June 1 2015.
  2.American Lung Association: Influenza. http://​www.​lung.​org/​lung-disease/​influenza/​ . Accessed June 1 2015.
  3.Centers for Disease Control and Prevention (CDC): Seasonal Influenza (Flu) in the Workplace. http://​www.​cdc.​gov/​niosh/​topics/​flu/​ . Accessed June 1 2015.
  4.Centers for Disease Control and Prevention (CDC): Overview of Influenza Surveillance in the United States. http://​www.​cdc.​gov/​flu/​weekly/​overview.​htm . Accessed June 1 2015.
  5.World Health Organization (WHO): Influenza (Seasonal): Fact sheet N°211. http://​www.​who.​int/​mediacentre/​factsheets/​fs211/​en/​ . Accessed June 1 2015.
  6.Food and Drug Administration. Guidance for industry on patient-reported outcome measures: use in medical product development to support labeling claims. Fed Regis. 2009;74:65132–3.
  7.Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, et al. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2--assessing respondent understanding. Value Health. 2011;14:978–88.PubMed CrossRef
  8.Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, et al. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument. Value Health. 2011;14:967–77.PubMed CrossRef
  9.Leidy NK, Vernon M. Perspectives on patient-reported outcomes: content validity and qualitative research in a changing clinical trial environment. Pharmacoeconomics. 2008;26:363–70.PubMed CrossRef
  10.Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, et al. Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) measures: report of the ISPOR task force for translation and cultural adaptation. Value Health. 2005;8:94–104.PubMed CrossRef
  11.Coons SJ, Gwaltney CJ, Hays RD, Lundy JJ, Sloan JA, Revicki DA, et al. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report. Value Health. 2009;12:419–29.PubMed CrossRef
  12.Osborne R, Hawthorne G, Papanicolaou M, Wegmueller Y. Measurement of rapid changes in health outcomes in people with influenza symptoms. J Outcomes Res. 2000;4:15–30.
  13.Osborne RH, Norquist JM, Elsworth GR, Busija L, Mehta V, Herring T, et al. Development and validation of the Influenza Intensity and Impact Questionnaire (FluiiQ). Value Health. 2011;14:687–99.PubMed CrossRef
  14.Ames NJ, Peng C, Powers JH, Leidy NK, Miller-Davis C, Rosenberg A, et al. Beyond intuition: patient fever symptom experience. J Pain Symptom Manage. 2013;46:807–16.PubMed CrossRef
  
• 作者单位：John H. Powers (1) (15)
  M. Lourdes Guerrero (2)
  Nancy Kline Leidy (3)
  Mary P. Fairchok (4) (5) (6)
  Alice Rosenberg (1)
  Andrés Hernández (7)
  Sonja Stringer (3)
  Christina Schofield (6)
  Patricia Rodríguez-Zulueta (8)
  Katherine Kim (3)
  Patrick J. Danaher (9)
  Hilda Ortega-Gallegos (2)
  Elizabeth Dansie Bacci (3)
  Nathaniel Stepp (10)
  Arturo Galindo-Fraga (2)
  Kristina St. Clair (11)
  Michael Rajnik (12)
  Erin A. McDonough (13)
  Michelande Ridoré (4) (5)
  John C. Arnold (14)
  Eugene V. Millar (4) (5)
  Guillermo M. Ruiz-Palacios (2)
  
  1. Clinical Monitoring and Research Program, Clinical Research Directorate, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, MD, 21702 in support of the Collaborative Clinical Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA
  15. 5601 Fishers Lane, Room 4D50, Rockville, MD, 20852, USA
  2. Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico
  3. Evidera, Bethesda, MD, USA
  4. Infectious Disease Clinical Research Program, Uniformed Services University, Bethesda, MD, USA
  5. Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA
  6. Madigan Army Medical Center, Tacoma, WA, USA
  7. Instituto Nacional de Enfermedades Infecciosas, Mexico City, Mexico
  8. Hospital General Dr. Manuel Gea González, Mexico City, Mexico
  9. San Antonio Health System, San Antonio, TX, USA
  10. Camp Lejeune, Jacksonville, NC, USA
  11. Naval Medical Center Portsmouth, Portsmouth, VA, USA
  12. Walter Reed National Military Medical Center, Bethesda, MD, USA
  13. Naval Health Research Center, San Diego, CA, USA
  14. Naval Medical Center San Diego, San Diego, CA, USA
  
• 刊物主题：Infectious Diseases; Parasitology; Medical Microbiology; Tropical Medicine; Internal Medicine;
• 出版者：BioMed Central
• ISSN：1471-2334

文摘

Background To develop content validity of a comprehensive patient-reported outcome (PRO) measure following current best scientific methodology to standardize assessment of influenza (flu) symptoms in clinical research.