Responsiveness and Clinical Validity of PROMIS Pain and Depression Measures

描述（由申请人提供）：疼痛和抑郁是医学临床实践中最常见的生理和心理症状。事实上，它们在大多数医学和精神疾病中无处不在。疼痛和抑郁症往往没有得到充分的治疗，并导致严重残疾，降低健康相关的生活质量，并增加 医疗保健成本和利用率。此外，它们在多达一半的患者中同时发生，并对治疗反应产生相互的负面影响。与许多疾病相反，体格检查和实验室/成像研究在评估疼痛和抑郁症方面的诊断作用有限。相反，评估疼痛和抑郁的标准是个人的自我报告，这使得患者报告的疼痛和抑郁措施的验证对研究和临床护理都至关重要。在本研究中，PROMIS疼痛和抑郁指标将被添加到4项大型研究（3项随机临床试验和1项队列研究）中，这些研究将于2012年开始招募受试者。我们拟定研究的样本量总计900例患者，范围为4项研究中每项研究200 - 250例患者。其中两项研究将招募慢性肌肉骨骼疼痛的初级保健患者，两项研究将招募神经系统疾病的专科门诊患者（卒中幸存者和轻度创伤性脑损伤患者）。在每项研究中，PROMIS测量以及非PROMIS疼痛和抑郁量表（用于帮助验证PROMIS量表的PHQ-9抑郁量表和简明疼痛量表）和其他验证项目将添加到研究受试者的基线和3个月随访评估中。PROMIS测量将包括PROMIS疼痛和抑郁简表和概况中的所有项目。我们的辅助研究的主要目的是通过以下方式在临床人群中对PROMIS固定长度疼痛和抑郁量表进行临床相关验证：（1）评估对变化的反应性和敏感性，（2）建立临床解释，包括开发最小重要差异（MID），以及（3）评估PROMIS抑郁量表的诊断操作特征，用于检测从情绪模块获得的金标准抑郁症诊断，诊断DSM-IV第一轴疾病（SCID）的结构化临床访谈。对于变化的敏感性，我们将使用所有4项研究的数据来评价PROMIS量表区分疼痛或抑郁随时间改善、保持不变或恶化的患者亚组的能力。3项随机临床试验还将用于检查组间（干预与对照）干预对治疗反应性的影响。对于MID，我们将使用德尔菲过程对基于锚点和基于分布的方法的数据进行三角测量，该过程将包括两个9人专家小组（1个用于抑郁症，1个用于疼痛）。我们的研究结果将大大增加PROMIS疼痛和抑郁措施的实用性和纳入临床实践以及转化研究。同样，PROMIS评分的有意义的解释将大大增强。 公共卫生的相关性：疼痛和抑郁症非常常见，但评估不足，因此，往往治疗不足，导致严重残疾，降低健康相关的生活质量，增加医疗保健成本和利用。美国国立卫生研究院资助的PROMIS疼痛和抑郁措施有可能改善这些条件的评价，但没有证明在临床人群的纵向研究的有效性。如果在临床人群中显示出敏感性、反应性和诊断准确性，这些简单可行的工具有望改善疼痛和抑郁的评估，从而减少患者的残疾和医疗保健利用，提高他们的生活质量。

DESCRIPTION (provided by applicant): Pain and depression are the most common physical and psychological symptoms presenting in medical clinical practice. Indeed, they are ubiquitous across most medical and psychiatric diseases. Both pain and depression are often inadequately treated and result in substantial disability, reduced health-related quality of life, and increased health care costs and utilization. Moreover, they co-occur in up to half of patients and have reciprocal negative effects on treatment response. In contrast to many diseases, physical examination and laboratory/imaging studies have a limited diagnostic role in the assessment of pain and depression. Instead the criterion for assessing both pain and depression is self report from an individual, making the validation of patient-reported measures of pain and depression critical to both research and clinical care. In this study, PROMIS pain and depression measures will be added to 4 large studies (3 randomized clinical trials and 1 cohort study) which are beginning subject enrollment in 2012. The sample size for our proposed study will total 900 patients, ranging from 200-250 patients from each of the 4 studies. Two of the studies will be enrolling primary care patients with chronic musculoskeletal pain and two studies will be enrolling specialty clinic patients with neurologic disorders (stroke survivors and patients with mild traumatic brain injury). In each study, the PROMIS measures as well as non-PROMIS pain and depression scales (the PHQ-9 depression scale and the Brief Pain Inventory used to assist in validating the PROMIS scales) and other validating items will be added to baseline and 3-month follow-up assessments of study participants. The PROMIS measures will include all items from the PROMIS pain and depression Short Forms and Profiles. The primary aims of our ancillary study will be to perform clinically-relevant validation of the PROMIS fixed-length pain and depression scales in clinical populations by (1) assessing responsiveness and sensitivity to change, (2) establishing clinical interpretations including developing minimally important differences (MIDs), and (3) assessing the diagnostic operating characteristics of the PROMIS depression scales for detecting gold standard depressive disorder diagnoses obtained from the mood module of the Structured Clinical Interview to Diagnose DSM-IV Axis I Disorders (SCID). For sensitivity to change, we will use data from all 4 studies to evaluate the ability of PROMIS scales to differentiate between subgroups of patients in whom pain or depression has improved, remained unchanged, or worsened over time. The 3 randomized clinical trials will also be used to examine between-group (intervention vs. control) intervention effects for responsiveness to treatment. For MIDs, we will triangulate data from anchor-based and distribution-based methods using a Delphi process that will include two 9-member expert panels (1 for depression and 1 for pain). Our study findings will greatly increase the utility and incorporation of PROMIS pain and depression measures into clinical practice as well as translational research. Likewise, the meaningful interpretation of PROMIS scores will be substantially enhanced. PUBLIC HEALTH RELVANCE: Pain and depression are exceedingly common yet under evaluated and consequently, often inadequately treated, resulting in substantial disability, reduced health-related quality of life, and increased health care costs and utilization. NIH-funded PROMIS pain and depression measures hold the potential to improve evaluation of these conditions but do not have demonstrated validity in longitudinal studies of clinic populations. If shown to be sensitive, responsive, and diagnostically accurate in clinical populations, these brief and feasible tools promise to improve evaluation of pain and depression, and accordingly, reduce patients' disability and healthcare utilization and increase their quality of life.