Assessing the Functional Impact of Chronic Pain

描述（由申请人提供）：拟议研发计划的总体目标是开发和演示一种新方法，用于客观测量患者治疗过程中疼痛及其变化的功能影响。该方法旨在补充现有的患者功能评估方法，这些方法目前基于自我报告、临床医生观察、患者和家庭一致性以及物理治疗师和/或职业治疗师的“快照”功能评估。第一阶段工作的中心目标是证明所提出的新方法的心理测量效用（即有效性和可靠性），用于评估疼痛诊所慢性或亚急性疼痛患者的疼痛功能影响（FIP）。第一阶段构建效度的成功将通过基于 n 倍交叉验证技术的 Bland-Altman 分析（以及零偏差、相等标准差和显着 R2 值的相应统计检验）来证明新方法预测每个传统心理测量仪器分数的准确性。此外，还将计算仪器间相关性，并进行探索性因素分析，以评估数据中表示的行为维度的数量。为了证明内部一致性可靠性，将为每种传统心理测量工具以及新方法计算克朗巴赫的阿尔法和项目总相关性。内部一致性可靠性的成功将通过证明 Cronbach's alpha = 0.70 的值和 0.30-0.70 范围内的项目总相关性来定义，这是通常推荐的值。此外，还将评估新 FIP 评估方法的“可用性”（与“功能性”相对）。将要求志愿者完成可用性调查，其中的信息将用于在实施第二阶段系统之前改进新的 FIP 评估方法。功能能力是评估任何慢性疼痛状况的重要组成部分。尽管人们对开发有助于评估与疼痛相关的残疾的心理测量工具给予了相当多的关注，但通过问卷收集准确的数据在实践中仍然是一个问题（例如，自我报告测量就其本质而言，并不反映患者在日常活动中的感受和功能）。所提出的技术提供了一种新方法，可以克服目前准确评估疼痛功能影响的局限性。

DESCRIPTION (provided by applicant): The overall goal of the proposed R&D program is to develop and demonstrate a new approach for objectively measuring the functional impact of pain, and changes thereto, during the course of a patient's treatment. The approach is intended to be a supplement to existing methods for assessing patient functioning, which are presently based on self-report, clinician observation, patient and family concordance, and "snapshot" functional assessments by physical therapists and/or occupational therapists. The central objective of the Phase I effort will be to demonstrate the psychometric utility (i.e., validity and reliability) of the proposed new approach for assessing the functional impact of pain (FIP) in pain clinic patients with chronic or subacute pain. Success for construct validity in Phase I will be designed by demonstrating the accuracy of the new approach in predicting each of the conventional psychometric instrument scores via Bland- Altman analysis (and corresponding statistical tests for zero bias, equal standard deviations, and significant R2 values) based on an n-fold cross-validation technique. Additionally, inter-instrument correlations will be computed and exploratory factor analysis will be performed to assess the number of behavioral dimensions represented in the data. To demonstrate internal-consistency reliability, Cronbach's alpha and item-total correlations will be computed for each of the conventional psychometric instruments as well as for the new approach. Success for internal-consistency reliability will be defined by demonstrating values for Cronbach's alpha = 0.70 and item-total correlations in the range 0.30-0.70, which are the generally recommended values. Additionally, the "usability" (as contrasted with "functionality") of the new FIP assessment method will be assessed. Volunteers will be asked to complete usability surveys, the information from which will be used to improve the new FIP assessment method prior to implementation of the Phase II system. Functional ability is a crucial component of the assessment of any chronic pain condition. Although considerable attention has been given to the development of psychometric instruments that facilitate the assessment of pain-related disability, collection of accurate data via questionnaires remains an issue in practice (e.g., self- report measures, by their nature, do not reflect how the patient feels and functions in day-to-day activity). The proposed technology offers a novel method for overcoming present limitations in accurately assessing the functional impact of pain.