Rinck G C, van den Bos G A, Kleijnen J, de Haes H J, Schadé E, Veenhof C H
Department of Clinical Epidemiology and Biostatistics, University of Amsterdam, The Netherlands.
J Clin Oncol. 1997 Apr;15(4):1697-707. doi: 10.1200/JCO.1997.15.4.1697.
The objective of this report is to explore methodologic issues on the basis of a systematic review of the literature of effectiveness research on palliative cancer care with regard to selection and characteristics of a study population, interventions, and outcome assessment.
A systematic review was performed of randomized clinical trials on comprehensive palliative care with quality assessment of the studies by three independent observers, using predefined quality criteria.
In the literature search, 11 relevant studies were identified. Without exception, methodologic problems were experienced. In two studies, the problems were so severe that no results were reported. Problems were associated with the recruitment of a study population in 10 studies, its homogeneity in six, patient attrition in four, defining and maintaining the contrast between the strategies in six, and selection of the outcome variables in four.
Effectiveness research in palliative care is complex and has many pitfalls. To enhance the quality of future palliative care trials and the validity of their results, we particularly stress the importance of careful case finding, strict eligibility criteria, precise documentation of the process of care, and comprehensive outcome measurement. The relation of structure, process, and outcome variables in comprehensive palliative care should be further explored. It is a challenge for future research to link patient outcomes to the quality of care, independent from the autonomous course of the disease and from personal characteristics.
本报告的目的是在对姑息性癌症护理有效性研究文献进行系统综述的基础上，探讨方法学问题，内容涉及研究人群的选择和特征、干预措施以及结果评估。
对综合姑息治疗的随机临床试验进行系统综述，由三名独立观察者使用预先定义的质量标准对研究进行质量评估。
在文献检索中，共识别出11项相关研究。无一例外，均存在方法学问题。其中两项研究的问题非常严重，未报告任何结果。问题涉及10项研究中研究人群的招募、6项研究中人群的同质性、4项研究中的患者流失、6项研究中策略间对比的定义和维持，以及4项研究中结果变量的选择。
姑息治疗的有效性研究复杂且存在诸多陷阱。为提高未来姑息治疗试验的质量及其结果的有效性，我们特别强调仔细病例查找、严格纳入标准、护理过程的精确记录以及全面结果测量的重要性。应进一步探索综合姑息治疗中结构、过程和结果变量之间的关系。将患者结果与护理质量相联系，而不考虑疾病的自然进程和个人特征，这对未来研究而言是一项挑战。
