A Fibromyalgia-Specific Extension of the PROMIS Network

PROMIS 网络的纤维肌痛特异性扩展

• 批准号: 7670266
• 负责人: David A Williams
• 金额: $ 19.2万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-08-01 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7670266
• 关键词: Address; Advanced Development; Advisory Committees; Affect; Agreement; Algorithms; Calibration; Characteristics; Chronic; Chronic Disease; Classification; Clinical; Clinical Trials; Clinical Trials Cooperative Group; Code; Computers; Consensus; Consult; Data; Development; Device or Instrument Development; Dimensions; Disease; Doctor of Philosophy; Fatigue; Fibromyalgia; Focus Groups; Generic Drugs; Goals; Health; Industry; Information Systems; International; Letters; Measurement; Measures; Medical; Methodology; Methods; Outcome; Outcome Measure; Pain; Patient Outcomes Assessments; Patients; Preparation; Property; Psychometrics; Public Health; Records; Recruitment Activity; Refractory; Research Personnel; Rheumatoid Arthritis; Sampling; Series; Sleep disturbances; System; Testing; Time; United States National Institutes of Health; Validity and Reliability; World Health Organization; clinically relevant; computerized; disability; experience; functional status; improved; instrument; interest; member; prevent; response; sound; theories; user-friendly; validation studies

DESCRIPTION (provided by applicant): Existing methods for assessing disease status and responsiveness to treatment in Fibromyalgia (FM) have been criticized on the grounds that (a) existing patient reported outcomes measures (PROs) fail to adequately assess the domains of relevance to patients with FM, (b) most existing instruments have been borrowed from other diseases and thus disease-specific PROs are largely undeveloped for FM, and (c) many of the existing measures have unfavorable psychometric properties and/or lack sufficient sensitivity to change. Thus, there is need for new methodologically sound PROs for FM that can be delivered in a traditional manner in the short term and via the more sensitive and efficient methodology associated with computer adaptive testing (CAT) in the longer term. Lack of consensus regarding the relevant assessment domains for FM has prevented the development of meaningful multi-dimensional instruments for FM; but recent agreement between projects within the WHO ICF initiatives and within OMERACT suggests that the time is right to initiate this type of instrument development. To this end, this proposal contains four aims: In the first, focus groups of FM patients will be conducted by the National Fibromyalgia Association (NFA) so as to generate disease-specific items that can supplement the more generic chronic illness item banks being developed by the NIH roadmap initiative PROMIS. Aim two will field test the disease-specific items along with the PROMIS item banks in a large representative sample of FM patients recruited through the NFA. A series of validation studies will be conducted under Aim three so as to support the use of the new disease- specific scales for administration in clinical trials in a traditional manner. Finally, under aim four, a CAT algorithm utilizing the combined PROMIS and FM disease-specific items will be developed and field tested. The final goal of this project will be the integration of the new FM-CAT module into the PROMIS network. The investigators of this proposal are already actively collaborating with ICF, OMERACT, and PROMIS, have track records in successful outcomes measurement development and advanced quantitative methods and possess clinical expertise in FM. The products resulting from this project will have direct applicability and utility in clinical trials involving FM and represent the next critical steps in refining the ability to identify useful and meaningful treatments for this refractory condition. This project is relevant to public health as it will provide a disease-specific measurement instrument to use in clinical trials thus leading to more effective methods for assessment and treatment of Fibromyalgia.

描述（由申请人提供）：用于评估纤维肌痛（FM）疾病状态和治疗反应的现有方法受到批评，因为（a）现有患者报告结果测量（PRO）未能充分评估与患者相关的领域对于 FM，(b) 大多数现有工具是从其他疾病借用的，因此针对 FM 的特定疾病 PRO 基本上没有开发出来，(c) 许多现有措施具有不利的心理测量特性和/或缺乏足够的对变化的敏感性。因此，需要新的方法论上合理的 FM PRO，在短期内可以以传统方式提供，而在长期内可以通过与计算机自适应测试 (CAT) 相关的更敏感和更有效的方法来提供。对于 FM 的相关评估领域缺乏共识，阻碍了有意义的 FM 多维工具的开发；但 WHO ICF 倡议和 OMERACT 内的项目之间最近达成的协议表明，启动此类工具开发的时机已经成熟。为此，该提案包含四个目标：首先，国家纤维肌痛协会 (NFA) 将开展 FM 患者焦点小组活动，以生成针对特定疾病的项目，以补充正在开发的更通用的慢性病项目库。由 NIH 路线图倡议 PROMIS 制定。目标二将在通过 NFA 招募的 FM 患者的大量代表性样本中现场测试特定疾病项目以及 PROMIS 项目库。将在目标三下进行一系列验证研究，以支持在临床试验中以传统方式使用新的疾病特异性量表。最后，在目标四下，将开发一种利用 PROMIS 和 FM 疾病特定项目相结合的 CAT 算法并进行现场测试。该项目的最终目标是将新的 FM-CAT 模块集成到 PROMIS 网络中。该提案的研究人员已经与 ICF、OMERACT 和 PROMIS 积极合作，在成功的结果测量开发和先进的定量方法方面拥有跟踪记录，并拥有 FM 的临床专业知识。该项目产生的产品将在涉及 FM 的临床试验中具有直接的适用性和效用，并代表着提高识别这种难治性疾病的有用且有意义的治疗方法的能力的下一个关键步骤。该项目与公共卫生相关，因为它将提供一种用于临床试验的疾病特异性测量仪器，从而为纤维肌痛的评估和治疗提供更有效的方法。

项目成果

The PROMIS FatigueFM Profile: a self-report measure of fatigue for use in fibromyalgia.

PROMIS FatigueFM Profile：用于治疗纤维肌痛的自我报告疲劳测量。

• DOI: 10.1007/s11136-016-1230-9
• 发表时间: 2016
• 期刊: Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation
• 作者: Kratz,AnnaL;Schilling,Stephen;Goesling,Jenna;Williams,DavidA
• 通讯作者: Williams,DavidA

Subgrouping a Large U.S. Sample of Patients with Fibromyalgia Using the Fibromyalgia Impact Questionnaire-Revised.

• DOI: 10.3390/ijerph18010247
• 发表时间: 2020-12-31
• 期刊: International journal of environmental research and public health
• 作者: Pérez-Aranda A;Feliu-Soler A;Mist SD;Jones KD;López-Del-Hoyo Y;Oliván-Arévalo R;Kratz A;Williams DA;Luciano JV
• 通讯作者: Luciano JV

Advances in the assessment of fibromyalgia.

• DOI: 10.1016/j.rdc.2009.05.007
• 发表时间: 2009-05
• 期刊: RHEUMATIC DISEASE CLINICS OF NORTH AMERICA
• 影响因子: 2.3
• 作者: Williams, David A.;Schilling, Stephen
• 通讯作者: Schilling, Stephen