Creating and Validating Child Adverse Event Reporting in Oncology Trials

在肿瘤学试验中创建和验证儿童不良事件报告

• 批准号: 8483681
• 负责人: Pamela S Hinds
• 金额: $ 69.81万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-01 至 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8483681
• 关键词: 20 year old; 8 year old; Adult; Adverse event; Age; Agreement; Brain; Cancer Patient; Caregivers; Caring; Child; Childhood; Children' s Oncology Group; Clinical; Clinical Trials; Cognitive; Common Terminology Criteria for Adverse Events; Companions; Data; Data Reporting; Development; Diagnosis; Disease; Documentation; Electronics; Ensure; Event; Fatigue; Federal Government; Goals; Interview; Knowledge; Language; Learning; Longitudinal Studies; Malignant Neoplasms; Measures; Medical; Methods; Monitor; National Cancer Institute; Neuraxis; Newly Diagnosed; Outcome; Pain; Parents; Patient Outcomes Assessments; Patient Self-Report; Patients; Pediatric Oncology; Phase; Population; Procedures; Property; Proxy; Psychometrics; Qualitative Evaluations; Quality of Care; Quality of life; Questionnaire Designs; Questionnaires; Reporting; Research; Research Infrastructure; Safety; Science; Severities; Signs and Symptoms; Site; Solid Neoplasm; Source; Specific qualifier value; Staging; Structure; Supportive care; Symptoms; System; Testing; Time; Toxic effect; Translating; Translations; Validity and Reliability; base; cancer therapy; cancer type; design; experience; improved; multidisciplinary; oncology; patient safety; prevent; public health relevance; risk benefit ratio; treatment effect

DESCRIPTION: Over 60% of children diagnosed with cancer will participate in a clinical trial; the great majority of these children will experience multiple treatment-related adverse events that require intense supportive care. The Federal Government mandates for safety monitoring that all trials report adverse events (AEs); defined by the National Cancer Institute (NCI) as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment. The standard practice in oncology trials is for the clinician to grade all AEs using the standard NCI lexicon of the Common Terminology Criteria for Adverse Events (CTCAE), but multiple studies in adult cancer populations found that clinicians underreport the number and severity of symptoms compared to what patients report. More than a third of the 790 AEs on the CTCAE have some subjective aspect to its identification, requiring patient-report to assure accuracy of the AE documentation. Given the known toxicity of cancer treatments on children's lives, the child's perspectives in grading subjective AEs must be integrated into AE reporting. Without including the child's AE reports, the risk/benefit ratio of cancer treatments wil not be accurately established. In a small number of studies comparing child, parent and clinician symptom ratings, clinicians were poor and caregivers only slightly better at recognizing the symptoms the children were experiencing. This new study with 6 Children's Oncology Group (COG) sites extends our team's current research with pediatric clinicians that identified 62 subjective AEs from the CTCAE that 7- to 20- year olds in cancer treatment could be expected to validly rate, and which could serve as the basis for designing a pediatric patient-report CTCAE (PRO-CTCAE) measure. This 5-year study includes 3 aims. In Aim 1, we will design both English and Spanish versions of a pediatric and caregiver-proxy version of the PRO- CTCAE by translating the 62 subjective AEs into child-friendly terms and create companion interview questions that are comprehensible to children and their caregiver-proxies. In Aim 2, we will use cognitive interviewing methods to evaluate how well children and caregiver-proxies understand and respond to the PRO-CTCAE questions. Strata will represent different cancer types and different age ranges. Aim 3 is a longitudinal study to evaluate the reliability, validity and responsiveness of the PRO-CTCAE measures with newly diagnosed children in cancer treatment, stratified by age and cancer types. We will also assess concordance of AE ratings by caregiver-proxies, clinicians and children over time and changing clinical conditions. This study constitutes a first step towards our long term research goal of documenting the differences in care management and outcomes when the PRO-CTCAE is incorporated into cancer clinical trials.

产品说明：超过60%被诊断患有癌症的儿童将参加临床试验;这些儿童中的绝大多数将经历多种治疗相关的不良事件，需要密集的支持性护理。联邦政府要求安全性监测所有试验报告不良事件（AE）;由国家癌症研究所（NCI）定义为与使用药物治疗存在时间关联的任何不利和非预期体征、症状或疾病。肿瘤学试验的标准实践是临床医生使用不良事件通用术语标准（CTCAE）的标准NCI词典对所有AE进行分级，但在成人癌症人群中进行的多项研究发现，与患者报告的情况相比，临床医生低估了症状的数量和严重程度。CTCAE中的790起AE中，超过三分之一的AE在识别时存在主观因素，需要患者报告以确保AE记录的准确性。鉴于癌症治疗对儿童生命的已知毒性，儿童对主观AE分级的观点必须纳入AE报告。如果不包括儿童的AE报告，癌症治疗的风险/受益比将无法准确确定。在少数比较儿童，父母和临床医生症状评级的研究中，临床医生很差，照顾者在识别儿童所经历的症状方面只略好。这项由6个儿童肿瘤组（COG）研究中心参与的新研究扩展了我们团队目前与儿科临床医生的研究，该研究从CTCAE中确定了62个主观AE，预计7至20奥尔兹的癌症治疗患者可以有效评估这些AE，并可作为设计儿科患者报告CTCAE（PRO-CTCAE）指标的基础。这项为期五年的研究包括三个目标。在目标1中，我们将通过将62起主观AE翻译为儿童友好术语，并创建儿童及其儿童代理人可理解的伴随访谈问题，设计PRO- CTCAE儿童和儿童代理人版本的英语和西班牙语版本。在目标2中，我们将使用认知访谈方法来评估儿童和儿童代理人对PRO-CTCAE问题的理解和回答情况。分层将代表不同的癌症类型和不同的年龄范围。目的3是一项纵向研究，旨在评价PRO-CTCAE指标在新诊断儿童癌症治疗中的可靠性、有效性和反应性，按年龄和癌症类型分层。我们还将评估随着时间的推移和临床条件的变化，代理人、临床医生和儿童的AE评级的一致性。本研究是我们实现长期研究目标的第一步，即记录将PRO-CTCAE纳入癌症临床试验时护理管理和结局的差异。