流感患者报告结局量表（Flu-PRO）的开发：一种用于评估流感症状的患者报告结局（PRO）工具。
Development of the Flu-PRO: a patient-reported outcome (PRO) instrument to evaluate symptoms of influenza.
作者信息
Powers John H, Guerrero M Lourdes, Leidy Nancy Kline, Fairchok Mary P, Rosenberg Alice, Hernández Andrés, Stringer Sonja, Schofield Christina, Rodríguez-Zulueta Patricia, Kim Katherine, Danaher Patrick J, Ortega-Gallegos Hilda, Bacci Elizabeth Dansie, Stepp Nathaniel, Galindo-Fraga Arturo, St Clair Kristina, Rajnik Michael, McDonough Erin A, Ridoré Michelande, Arnold John C, Millar Eugene V, Ruiz-Palacios Guillermo M
机构信息
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.
, 5601 Fishers Lane, Room 4D50, Rockville, MD, 20852, USA.
出版信息
BMC Infect Dis. 2016 Jan 5;16:1. doi: 10.1186/s12879-015-1330-0.
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.
METHODS
Stage I (Concept Elicitation): 1:1 telephone interviews with influenza-positive adults (≥18 years) in the US and Mexico within 7 days of diagnosis. Participants described symptom type, character, severity, and duration. Content analysis identified themes and developed the draft Flu-PRO instrument. Stage II (Cognitive Interviewing): The Flu-PRO was administered to a unique set of influenza-positive adults within 14 days of diagnosis; telephone interviews addressed completeness, respondent interpretation of items and ease of use.
RESULTS
Samples: Stage I: N = 46 adults (16 US, 30 Mexico); mean (SD) age: 38 (19), 39 (14) years; % female: 56%, 73%; race: 69% White, 97% Mestizo. Stage II: N = 34 adults (12 US, 22 Mexico); age: 37 (14), 39 (11) years; % female: 50%, 50%; race: 58% White, 100% Mestizo.
SYMPTOMS
Symptoms identified by >50%: coughing, weak or tired, throat symptoms, congestion, headache, weakness, sweating, chills, general discomfort, runny nose, chest (trouble breathing), difficulty sleeping, and body aches or pains. No new content was uncovered during Stage II; participants easily understood the instrument.
CONCLUSIONS
Results show the 37-item Flu-PRO is a content valid measure of influenza symptoms in adults with a confirmed diagnosis of influenza. Research is underway to evaluate the suitability of the instrument for children and adolescents. This work can form the basis for future quantitative tests of reliability, validity, and responsiveness to evaluate the measurement properties of Flu-PRO for use in clinical trials and epidemiology studies.
背景
遵循当前最佳科学方法开发一种全面的患者报告结局（PRO）测量工具，以规范临床研究中流感症状的评估。
方法
第一阶段（概念引出）：对美国和墨西哥诊断后7天内的流感阳性成年人（≥18岁）进行1:1电话访谈。参与者描述症状类型、特征、严重程度和持续时间。内容分析确定主题并制定流感PRO工具草案。第二阶段（认知访谈）：在诊断后14天内将流感PRO应用于一组独特的流感阳性成年人；电话访谈涉及完整性、受访者对项目的理解和易用性。
结果
样本：第一阶段：N = 46名成年人（16名美国，30名墨西哥）；平均（标准差）年龄：38（19）岁，39（14）岁；女性比例：56%，73%；种族：69%白人，97%梅斯蒂索人。第二阶段：N = 34名成年人（12名美国，22名墨西哥）；年龄：37（14）岁，39（11）岁；女性比例：50%，50%；种族：58%白人，100%梅斯蒂索人。
症状
超过50%的人提及的症状：咳嗽、虚弱或疲倦、咽喉症状、鼻塞、头痛、乏力、出汗、寒战、全身不适、流鼻涕、胸部（呼吸困难）、睡眠困难和身体疼痛。第二阶段未发现新内容；参与者很容易理解该工具。
结论
结果表明，37项流感PRO是确诊流感的成年人流感症状的内容有效测量工具。正在进行研究以评估该工具对儿童和青少年的适用性。这项工作可为未来评估流感PRO在临床试验和流行病学研究中使用的可靠性、有效性和反应性的定量测试奠定基础。
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