Low Back Pain in Older Veterans: Preparing for Personalized Care

描述(由申请人提供)： 拟议的试点应用旨在为三个地点的随机对照临床疗效试验做准备，该试验在患有下腰痛(LBP)的老年退伍军人中比较以患者为中心的综合评估和治疗(PCCET)与成像相关的常规护理(IAUC)的结果。刚刚做过腰椎磁共振成像(MRI)的退伍军人将成为目标，因为这些患者往往没有全面的病史和体检来确定导致他们疼痛和残疾的所有因素，因此，经历次优结果的风险很高。许多MRI确诊的退行性腰椎病变在老年人中是偶然的，而且它的确诊通常 导致无效和潜在危险的侵入性手术。这项试点研究有四个目标。目的1：通过审查电子病历的纳入和排除标准(没有需要紧急LBP治疗的危险信号，没有脊柱手术，没有痴呆)，评估未来临床有效性试验招募策略的可行性。计划接受腰椎核磁共振检查的65-89岁退伍军人的记录将在三个地点分别进行为期一年的审查。据估计，未来的临床疗效试验将需要314名参与者(阿尔法.025，功率90%，效果0.4)，以检测两个主要结果指标--罗兰残疾问卷(RDQ)和短体能电池(SPPB)--组之间的有意义的差异。目的2：评估评价者之间对结构化评估的一致性，该评估将用于指导未来临床疗效试验的PCCET组的LBP护理。首席调查员之前已经制定并发布了LBP评估方案。她将在三个地点(匹兹堡、迈阿密、里士满)每个地点向两到三个老年医生提供者讲授该方案的执行情况，并将使用该工具评估45名老年退伍军人(每个地点15名)。退伍军人还将接受其他关键疼痛和残疾产生因素的评估-抑郁(使用CES-D)、焦虑(使用GAD-7)、轻度认知障碍(使用基于计算机的轻度认知障碍评估)、恐惧避免信念(使用恐惧避免信念问卷)和疼痛应对技能(使用认知策略问卷)。PI和老年医生提供者将使用这些数据与补充的临床访谈相结合，从结构化的检查表中识别LBP的贡献者和残疾，并将评估评分者之间的协议。我们将培训供应商以 评价者之间的协议&>.95。目的3：通过评估IAUC和PCCET期间主要结果的预期变化，估计未来临床疗效TRIL的样本量。对于IAUC，另一组45名退伍军人(每个地点15名)将通过初级保健提供者签署的信件被邀请参加。志愿者将接受现场评估，以确认资格并收集临床试验的主要结果指标-RDQ和SPPB。参与者将每月接到电话，收集有关寻求和收到的LBP干预措施的结构化信息。对于PCCET，20名在PI疼痛诊所接受治疗的退伍军人将以类似于IAUC参与者的方式接受跟踪。RDQ和SPPB将在6个月内重复，75%的参与者在12个月内重复。目的4：标准化未来临床疗效试验中PCCET组将提供的治疗。这将通过借鉴循证文献和一个由33名成员组成的跨学科专家小组(老年医学、老年药理学、老年精神病学、腰痛、止痛药、初级保健、心理学、康复医学和风湿学)来实现，并使用改进的德尔菲技术。完成上述目标后，我们将为设计临床疗效试验做好充分准备，该试验有可能改善数百万年长退伍军人的功能和生活质量。 公共卫生相关性： 目前，美国有900多万65岁以上的退伍军人，腰背痛(LBP)是这些人致残的最常见原因之一。1，17当使用高级成像(例如核磁共振)对这些患者进行评估并将其视为脊柱老化而不是患有脊柱疼痛的老年人时，结果往往不太理想。脊椎关节炎在有或没有疼痛的老年人中很常见，脊柱以外的情况，如髋关节炎、抑郁症和纤维肌痛可能导致LBP和残疾，但从业者通常对这些情况缺乏教育。4，5，48，49因此，我们没有能力为患有LBP的老年退伍军人实施1998年VHA国家疼痛管理战略。这项先导性研究将为未来的随机对照试验提供信息，以评估与常规护理相比，接受以患者为中心的综合治疗的下背部MRI治疗的65-89岁退伍军人的益处。我们相信，以患者为中心的综合方法可以为数百万年长的退伍军人节省大量痛苦。

DESCRIPTION (provided by applicant): The proposed pilot application is designed to prepare for a three-site randomized controlled clinical efficacy trial that compares, in older veterans with low back pain (LBP) outcomes associated with patient-centered comprehensive evaluation and treatment (PCCET) versus imaging-associated usual care (IAUC). Veterans who have just had lumbar Magnetic Resonance Imaging (MRI) will be targeted, as these patients often have not had a comprehensive history and physical examination to identify all contributors to their pain and disability and, therefore, are at high risk of experiencing suboptimal outcomes. Much of MRI-identified degenerative lumbar pathology is incidental in older adults and its identification often leads to invasive procedures that are ineffective and potentially dangerous. The pilot study has four aims. Aim 1: Evaluate the feasibility of the recruitment strategy for the future clinical effiacy trial by reviewing electronic medical records for inclusion and exclusion criteria (no red flags tht would require urgent LBP treatment, no previous spine surgery, no dementia). Records of veterans age 65-89 who are scheduled for a lumbar MRI will be reviewed at each of the three sites for one year. An estimated 314 participants will be needed for the future clinical efficacy trial (alpha .025, power 90%, effect 0.4) to detect meaningful between group differences in two primary outcome measures, the Roland Disability Questionnaire (RDQ) and the Short Physical Performance Battery (SPPB). Aim 2: Assess inter-rater agreement of the structured assessment that will be used to guide LBP care in the PCCET arm of the future clinical efficacy trial. The principal investigator has previously developed and published a LBP assessment protocol. She will teach two-three geriatrician providers at each of the three sites (Pittsburgh, Miami, Richmond) in performance of the protocol and 45 older veterans (15 at each site) will be evaluated using this tool. Veterans also will be evaluated for other key pain and disability generators - depression (with the CES-D), anxiety (with the GAD-7), mild cognitive impairment (with the computer-based assessment of mild cognitive impairment), fear avoidance beliefs (with the Fear Avoidance Beliefs Questionnaire), and pain coping skills (with the Cognitive Strategies Questionnaire). The PI and geriatrician providers will use these data combined with supplemental clinical interviews as indicated, to identify the contributors to LBP and disability from a structured checklist and inter-rater agreement will be evaluated. We will train providers to an inter-rater agreement of > .95. Aim 3: Estimate sample size for the future clinical efficacy tril by assessing the anticipated change in primary outcomes during IAUC and PCCET. For IAUC, another group of 45 veterans (15 at each site) will be invited to participate via primary care provider-signed letters. Volunteers will be evaluated on-site to confirm eligibility and collect th primary outcome measures for the clinical trial - the RDQ and the SPPB. Participants will be telephoned monthly to collect structured information on LBP interventions sought and received. For PCCET, 20 veterans treated in the PI's pain clinic will be followed in a manner similar to the IAUC participants. The RDQ and SPPB will be repeated in 6 months on all and 12 months on 75% of participants. Aim 4: Standardize the treatments that will be delivered in the PCCET arm of the future clinical efficacy trial. This will be accomplished by drawing from evidence-based literature and a 33-member interdisciplinary panel of experts (geriatric medicine, geriatric pharmacology, geriatric psychiatry, low back pain, pain medicine, primary care, psychology, rehabilitation medicine and rheumatology) using a Modified Delphi technique. After accomplishing the aims outlined, we will be well- prepared to design the clinical efficacy trial tht has the potential to improve function and quality of life for millions of older veterans. PUBLIC HEALTH RELEVANCE: Currently there are over 9 million United States veterans age 65 and older and low back pain (LBP) is one of the most common causes of disability in these individuals.1,17 When these patients are evaluated using advanced imaging (e.g., MRI) and treated as an aging spine rather than an older adult with spine pain, results are often suboptimal. Spinal arthritis is common in older adults with and without pain and conditions outside of the spine such as hip arthritis, depression, and fibromyalgia may be responsible for LBP and disability, but practitioners are often poorly educated about these conditions.4,5,48,49 Thus we are ill-equipped to implement the 1998 VHA National Pain Management Strategy for older veterans with LBP. This pilot study will inform a future randomized controlled trial to evaluate the benefits in veterans with LBP age 65-89 who have undergone lower back MRI of patient-centered comprehensive treatment as compared with usual care. We believe the patient-centered comprehensive approach could save substantial suffering for millions of older veterans.