Predictors of Pain Severity and Pain-Related Outcomes in Individuals with Sickle Cell Disease
镰状细胞病患者疼痛严重程度和疼痛相关结果的预测因子
基本信息
- 批准号:10721630
- 负责人:
- 金额:$ 13.57万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-08-15 至 2028-07-31
- 项目状态:未结题
- 来源:
- 关键词:AcuteAddressAdolescenceAdolescent and Young AdultAdultAffectAgeBiologicalCharacteristicsChildChildhoodChronicComplexCross-Sectional StudiesDataDevelopmentEnrollmentFemaleFundingFutureGenotypeGlobinGoalsHealth Care CostsHereditary DiseaseIndividualInterventionLeadLinear RegressionsLinkLongitudinal StudiesLow incomeMeasuresModelingNatureOpioidOutcomeOutcome AssessmentPainPain managementPathogenesisPatient Outcomes AssessmentsPatient-Focused OutcomesPatientsPersistent painPersonsPhysical FunctionPolynomial ModelsPositioning AttributePredictive FactorProceduresPrognosisPsychological FactorsQuality of lifeRecurrent painRegistriesResearchResearch DesignRiskSamplingSecondary painSelf EfficacySensorySeveritiesSickle Cell AnemiaStatistical Data InterpretationStatistical MethodsTestingTimeTrainingUnited StatesWorkbiopsychosocialcareerchronic painclinical decision-makingclinical prognosticcohortcopingeffective interventionemerging adulthealth care service utilizationimprovedinterestlongitudinal, prospective studymortalitynon-opioid analgesicpain catastrophizingpain modelpain outcomepain reliefpain sensitivitypain-related disabilityphysically handicappedpredictive modelingprimary outcomeprognostic modelprognostic toolpsychologicpsychological distresspsychosocialsexsociodemographic predictorsvaso-occlusive crisis
项目摘要
Severe, disabling pain is the hallmark of sickle cell disease (SCD). SCD pain is associated with poor quality of
life, early mortality, and high healthcare costs. Clinicians face great challenges in managing SCD pain because
of the poor understanding of the etiology of chronic/persistent SCD pain and the absence of validated clinical
prognostic tools that can accurately identify individuals with SCD who are at risk of developing severe,
persistent pain with associated physical and/or psychological disability. The overall objective of this project is to
identify predictors of pain severity and pain-related outcomes in SCD using a prospective, longitudinal study
design informed by the biopsychosocial model of pain. This proposal is supported by the hypothesis that painspecific
psychological and sensory factors are strong, modifiable predictors of SCD pain severity and painrelated
outcomes. The understanding of pain-specific psychological and sensory predictors of SCD pain
outcomes is anticipated to have important implications for (1) identifying SCD patients who are at risk for
severe pain outcomes, (2) informing preventive and therapeutic management of SCD pain, and (3) selecting
patients for clinical trials of non-opioid interventions for SCD pain. The hypothesis will be tested by pursuing
two specific aims: Aim 1) Determine psychological predictors of pain outcomes; and Aim 2) Ascertain the
strength of pain distribution and sensitivity as predictors of pain outcomes. The candidate will use reliable and
well validated pain-specific patient-reported outcome (PRO) questionnaires to evaluate the strength of
psychological factors for predicting pain severity and other pain-related outcomes in the study cohort (Aim 1)
and will use body mapping and quantitative sensory testing (QST) to examine sensory predictors of pain
outcomes (Aim 2). The prospective, longitudinal design of this study and the use of biopsychosocial model of
pain are innovative. The candidate's long-term goal is to become an interdisciplinary SCD pain expert who is
a leading contributor to the treatment and understanding of the etiology and prognosis of chronic pain in
adolescents and young adults with SCD. Her interdisciplinary training background in pediatrics and
anesthesiology uniquely positions her for pursuing this research agenda. Through a detailed and specific
career development plan developed in conjunction with her mentoring panel, the candidate will acquire formal
training and expertise in SCD management, QST, assessment of the conceptual and psychometric properties
of PROs, and advanced statistical modeling (risk prediction and prognostic modeling). Her mentoring and
advisory committee includes an outstanding group of experts in psychosocial influencers of chronic pain
(Francis J. Keefe PhD, Duke), QST (Claudia M. Campbell PhD, Johns Hopkins), SCD (Nirmish Shah MD
and Paula Tanabe PhD, Duke; and Wally Smith MD, Virginia Commonwealth University), predictive modeling
(Yi-Ju Li, PhD, Duke) and prognostic research in pain (Andrey Bortsov MD/PhD, Duke). Successful
completion of this project is anticipated to improve the quality of life of individuals living with SCD.
严重的致残性疼痛是镰状细胞病(SCD)的标志。SCD疼痛与低质量的
寿命、早期死亡率和高昂的医疗费用。临床医生在管理SCD疼痛方面面临巨大挑战,
对慢性/持续性SCD疼痛的病因学理解不足,缺乏经验证的临床研究,
可以准确识别患有SCD的个体的预后工具,
持续性疼痛,伴有身体和/或心理残疾。该项目的总体目标是
采用前瞻性纵向研究确定SCD患者疼痛严重程度和疼痛相关结局的预测因子
设计基于疼痛的生物心理社会模型。这一提议得到了以下假设的支持:
心理和感觉因素是SCD疼痛严重程度和疼痛相关性的强有力的、可改变的预测因子。
结果。对SCD疼痛特异性心理和感觉预测因子的理解
预期结果对以下方面具有重要意义:(1)识别存在以下风险的SCD患者:
严重疼痛结局,(2)告知SCD疼痛的预防和治疗管理,以及(3)选择
用于SCD疼痛的非阿片类药物干预的临床试验的患者。这个假设将通过追踪
两个具体目标:目标1)确定疼痛结果的心理预测因素;目标2)确定
疼痛分布强度和敏感性作为疼痛结局的预测因子。候选人将使用可靠和
经过充分验证的疼痛特异性患者报告结局(PRO)问卷,以评估
预测研究队列中疼痛严重程度和其他疼痛相关结局的心理因素(目的1)
并将使用身体映射和定量感觉测试(QST)来检查疼痛的感觉预测因素
(目标2)。本研究的前瞻性、纵向设计和生物心理社会模型的使用,
疼痛是创新的。候选人的长期目标是成为一个跨学科的SCD疼痛专家,
在慢性疼痛的病因和预后的治疗和理解的主要贡献者,
患有SCD的青少年和年轻人。她在儿科的跨学科培训背景,
麻醉学使她在追求这一研究议程方面处于独特的地位。通过详细而具体的
与她的指导小组一起制定职业发展计划,候选人将获得正式的
SCD管理、QST、概念和心理测量属性评估方面的培训和专业知识
PRO和高级统计建模(风险预测和预后建模)。她的指导和
咨询委员会包括一个杰出的专家小组在心理社会影响的慢性疼痛
(弗朗西斯J.基夫博士,杜克),QST(克劳迪娅M.坎贝尔博士,约翰霍普金斯),SCD(Nirmish Shah医学博士
和Paula田边博士,杜克;和Wally Smith医学博士,弗吉尼亚联邦大学),预测建模
(Yi-Ju Li,PhD,杜克)和疼痛的预后研究(Andrey Bortsov MD/PhD,杜克)。成功
预计该项目的完成将改善患有SCD的个人的生活质量。
项目成果
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