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临床试验与生活质量评估:护士的观点

Clinical trials and quality of life assessment: the nurses' viewpoint.

作者信息

Molin C, Arrigo C

机构信息

Department of Oncology, Radiumhemmet, Karolinska Hospital, Stockholm, Sweden.

出版信息

Eur J Cancer. 1995;31A Suppl 6:S8-10. doi: 10.1016/0959-8049(95)00495-5.

DOI:10.1016/0959-8049(95)00495-5
PMID:8534529
Abstract

The rationale for quality of life assessment has been largely developed in the literature. Quality of life is an important concept in the oncology environment because the physical, psychological and social wellbeing of patients are affected both by the disease and the related treatments. The relevance of quality of life assessment to nursing clinical practice has been discussed by several authors. There is a need to use more valid and reliable instruments to plan appropriate nursing care, to evaluate and document the effect of nursing interventions. In clinical trials, quality of life assessment is being used increasingly to predict patients' outcomes and to evaluate medical and nursing interventions. Nurses' viewpoints of potential benefits and pitfalls related to quality of life assessment are discussed. Among the benefits, it is usually considered that therapeutic interventions might be improved. These could be adjusted and individualised and the need for supportive care interventions might be evaluated more accurately. As for the pitfalls, the quality of life evaluation causes an extra burden if its implementation is not properly co-ordinated and if poor or incomplete guidelines are provided to patients and staff. Proposals for implementing effective quality of life assessment in clinical trials are discussed. Basic requirements, such as preliminary instructions, guidelines for administration of the questionnaire and proposals for reducing missing evaluations, are presented.

摘要

生活质量评估的基本原理在文献中已有大量阐述。生活质量在肿瘤学领域是一个重要概念,因为疾病及其相关治疗会影响患者的身体、心理和社会福祉。几位作者探讨了生活质量评估与护理临床实践的相关性。有必要使用更有效、更可靠的工具来规划适当的护理,评估并记录护理干预的效果。在临床试验中,生活质量评估越来越多地用于预测患者的预后,并评估医疗和护理干预措施。文中讨论了护士对于生活质量评估潜在益处和缺陷的观点。在益处方面,通常认为可以改进治疗干预措施。这些措施可以进行调整和个性化定制,并且可以更准确地评估支持性护理干预措施的需求。至于缺陷,如果生活质量评估的实施没有得到妥善协调,并且向患者和工作人员提供的指导方针不佳或不完整,那么生活质量评估会造成额外负担。文中讨论了在临床试验中实施有效生活质量评估的建议。提出了一些基本要求,如初步说明、问卷管理指南以及减少缺失评估的建议。

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引用本文的文献

1
Patient-reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers.临床试验中患者报告结局(PRO)评估:对试验方案撰写者指南的系统评价
PLoS One. 2014 Oct 15;9(10):e110216. doi: 10.1371/journal.pone.0110216. eCollection 2014.