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癌症患者临床应用中患者报告结局评估的亲肿瘤选择——一项混合方法多中心横断面探索性研究

PRO-ONKO-selection of patient-reported outcome assessments for the clinical use in cancer patients-a mixed-method multicenter cross-sectional exploratory study.

作者信息

Schmidt Heike, Merkel Daniela, Koehler Michael, Flechtner Hans-Henning, Sigle Jörg, Klinge Bernd, Jordan Karin, Vordermark Dirk, Landenberger Margarete, Jahn Patrick

机构信息

Medical Faculty, Institute of Health and Nursing Sciences, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.

Department of Hematology and Oncology, University Hospital, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.

出版信息

Support Care Cancer. 2016 Jun;24(6):2503-12. doi: 10.1007/s00520-015-3055-4. Epub 2015 Dec 16.

Abstract

PURPOSE

Cancer patients frequently suffer from multiple symptoms often impairing functional status and health-related quality of life (HRQOL). A comprehensive assessment including patient-reported outcomes (PROs) is recommended to enable individualized supportive care. However, PRO assessments are still not part of routine clinical practice. Therefore, this project aimed to compile an item pool from validated assessment instruments to facilitate the use of PROs for clinical decision-making in oncology clinics.

METHODS

This qualitative dominant mixed-method cross-sectional exploratory study was carried out in four centers and comprised two stages. Stage I: Six interdisciplinary focus groups were conducted to choose questionnaires meeting particular clinical requirements. Stage II: Adult patients with heterogeneous cancer diagnoses, receiving in- or out-patient treatment were asked to participate and complete the chosen questionnaires (participation 71/74). Resulting PROs were compared with clinical records. Health care professionals (HCPs) and patients rated the usefulness for routine clinical practice.

RESULTS

The European Organisation of Research and Treatment of Cancer (EORTC) QLQ-C30 and Distress Thermometer were chosen for screening and M.D. Anderson Symptom Inventory (MDASI) and EORTC single items for monitoring. Comparison of n = 88 PRO assessments with clinical records showed consistent documentation of side effects like fever and emesis. Symptoms like fatigue, sadness, or sleep disturbance were not documented regularly in the medical records but captured by PRO assessments. Patients and HCPs judged the chosen questionnaires and electronic data collection as useful.

CONCLUSIONS

Future studies should examine how PROs can complement or substitute routine documentation in order to achieve standardized assessment and documentation during the treatment process in different settings and examine possible benefits for patients.

摘要

目的

癌症患者经常遭受多种症状的折磨,这些症状往往会损害其功能状态和健康相关生活质量(HRQOL)。建议进行包括患者报告结局(PROs)在内的综合评估,以实现个性化的支持性护理。然而,PRO评估仍未成为常规临床实践的一部分。因此,本项目旨在从经过验证的评估工具中编制一个项目库,以促进PROs在肿瘤诊所临床决策中的应用。

方法

本定性为主的混合方法横断面探索性研究在四个中心进行,包括两个阶段。第一阶段:开展了六个跨学科焦点小组,以选择符合特定临床要求的问卷。第二阶段:邀请患有不同癌症诊断、正在接受门诊或住院治疗的成年患者参与并完成所选问卷(参与率71/74)。将所得的PROs与临床记录进行比较。医疗保健专业人员(HCPs)和患者对其在常规临床实践中的有用性进行了评分。

结果

选择了欧洲癌症研究与治疗组织(EORTC)QLQ-C30和痛苦温度计进行筛查,选择了MD安德森症状量表(MDASI)和EORTC单项量表进行监测。将n = 88项PRO评估与临床记录进行比较,结果显示发热和呕吐等副作用的记录一致。疲劳、悲伤或睡眠障碍等症状在病历中没有定期记录,但通过PRO评估得以捕捉。患者和HCPs认为所选问卷和电子数据收集很有用。

结论

未来的研究应探讨PROs如何补充或替代常规记录,以便在不同环境下的治疗过程中实现标准化评估和记录,并研究对患者可能带来的益处。

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