Recommended Patient-Reported Core Set of Symptoms to Measure in Adult Cancer Treatment Trials
Recommended Patient-Reported Core Set of Symptoms to Measure in Adult Cancer Treatment Trials
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DOI：
10.1093/jnci/dju129
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发表时间：
2014-07-01
影响因子：
10.3
通讯作者：
Bruner, Deborah Watkins
中科院分区：
文献类型：
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作者：
Reeve, Bryce B.;Mitchell, Sandra A.;Bruner, Deborah Watkins
背景 美国国家癌症研究所的症状管理和健康相关生活质量指导委员会召开了一次临床试验计划会议（2011 年 9 月），以确定要在肿瘤学试验中评估的核心症状组，以便更好地了解治疗效果和毒性并促进交叉研究比较。我们报告了证据合成和建立共识努力的结果，最终提出了在成人癌症临床试验中测量核心症状的建议，其中包括患者报告的结果 (PRO)。方法我们使用了数据驱动的共识建立流程。包括患者代表在内的专家小组对文献（2001-2011）进行了系统回顾，并分析了六个大型数据集。结果在多方利益相关者会议上进行了审查，得出了最终结果，强调了不同癌症人群的症状患病率、对健康结果和生活质量的影响，以及归因于疾病或抗癌治疗。结果 我们建议考虑将一组 12 种核心症状纳入测量 PRO 的临床试验中，具体为疲劳、失眠、疼痛、厌食（食欲不振）、呼吸困难、认知问题、焦虑（包括担忧）、恶心、抑郁（包括悲伤）、感觉神经病变、便秘和腹泻。纳入症状和其他患者报告的终点应该是合理的、假设驱动的并且对患者有意义。结论该核心集将促进对癌症试验中常见和临床相关疾病和治疗相关症状的一致评估。因此，它为支持数据协调和继续努力加强癌症临床试验和观察研究中以患者为中心的结果的衡量奠定了基础。
Background The National Cancer Institute's Symptom Management and Health-Related Quality of Life Steering Committee held a clinical trials planning meeting (September 2011) to identify a core symptom set to be assessed across oncology trials for the purposes of better understanding treatment efficacy and toxicity and to facilitate cross-study comparisons. We report the results of an evidence-synthesis and consensus-building effort that culminated in recommendations for core symptoms to be measured in adult cancer clinical trials that include a patient-reported outcome (PRO).Methods We used a data-driven, consensus-building process. A panel of experts, including patient representatives, conducted a systematic review of the literature (2001-2011) and analyzed six large datasets.Results were reviewed at a multistakeholder meeting, and a final set was derived emphasizing symptom prevalence across diverse cancer populations, impact on health outcomes and quality of life, and attribution to either disease or anticancer treatment. Results We recommend that a core set of 12 symptoms-specifically fatigue, insomnia, pain, anorexia (appetite loss), dyspnea, cognitive problems, anxiety (includes worry), nausea, depression (includes sadness), sensory neuropathy, constipation, and diarrhea-be considered for inclusion in clinical trials where a PRO is measured. Inclusion of symptoms and other patient-reported endpoints should be well justified, hypothesis driven, and meaningful to patients.Conclusions This core set will promote consistent assessment of common and clinically relevant disease-and treatment-related symptoms across cancer trials. As such, it provides a foundation to support data harmonization and continued efforts to enhance measurement of patient-centered outcomes in cancer clinical trials and observational studies.