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证明一种新方法，用于客观测量患者治疗过程中疼痛的功能影响及其变化。该方法旨在补充现有的方法，用于评估患者的功能，这是目前基于自我报告，临床医生观察，患者和家庭的一致性，和“快照”功能评估的物理治疗师和/或职业治疗师。第一阶段工作的中心目标是证明心理测量效用（即，有效性和可靠性）的建议的新方法评估疼痛的功能影响（FIP）在疼痛门诊慢性或亚急性疼痛患者。将通过基于n重交叉验证技术的Bland-Altman分析（以及零偏倚、等标准差和显著R2值的相应统计检验）证明新方法在预测每种常规心理测量工具评分方面的准确性来设计I期的结构效度成功。此外，将计算仪器间相关性，并进行探索性因素分析，以评估数据中代表的行为维度数量。为了证明内部一致性的可靠性，克朗巴赫的α和项目总的相关性将被计算为每个传统的心理测量工具，以及为新的方法。内部一致性可靠性的成功将通过证明Cronbach α = 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”相反）。志愿者将被要求完成可用性调查，其中的信息将用于改进新的FIP评估方法，然后实施第二阶段系统。功能能力是评估任何慢性疼痛状况的重要组成部分。虽然已经相当重视促进疼痛相关残疾评估的心理测量工具的开发，但通过问卷收集准确数据在实践中仍然是一个问题（例如，自我报告测量，就其性质而言，不反映患者在日常活动中的感觉和功能）。所提出的技术提供了一种新的方法，用于克服目前在准确评估疼痛的功能影响方面的局限性。

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.