INTEGRATING HEALTH-RELATED QUALITY-OF-LIFE INTO CROSS-NATIONAL CLINICAL-TRIALS
INTEGRATING HEALTH-RELATED QUALITY-OF-LIFE INTO CROSS-NATIONAL CLINICAL-TRIALS
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DOI：
10.1007/bf00422217
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发表时间：
1993-12-01
影响因子：
3.5
通讯作者：
AARONSON, NK
中科院分区：
文献类型：
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作者：
CELLA, DF;WIKLUND, I;AARONSON, NK
当计划在多国临床试验中实施健康相关生活质量（HRQL）评估时，至少有四个一般考虑因素：疾病或病症的自然史、人群特征、考虑中的治疗以及临床试验组织的结构和功能。在计划、实施和分析跨国临床试验时，必须同时考虑这些因素。给定疾病或病症的自然史有五个相关的极性组成部分：（1）时间范围（急性与慢性）;（2）生命威胁（是与否）;（3）疾病学（存在与不存在）;（4）症状表达（偶发与持续）;和（5）功能影响（存在与不存在）。人口特征的差异（例如，年龄、条件、共病），必须在开始试验前从概念上、在计划实施时从方法上、在收集数据后从统计学上加以解决。在治疗方面，必须考虑不利和积极影响以及影响时间等问题。计划、实施和分析HRQL数据所需的方法将取决于任何给定临床试验中人员和资源的集中程度。可能的范围从完全集中到完全分散，在完全集中的情况下，数据收集和传输的所有规划和协调都由一个办公室完成，在完全分散的情况下，工作分配给参与的研究中心和感兴趣的研究者。最后，通过提高对临床试验中评估HRQL的重要性和价值的认识，提高了HRQL数据收集的成功实施。开展治疗试验的研究者可以将结果调查扩展到更广泛的功能和健康领域，而不是更传统的症状特征、发病率和死亡率结果所定义的领域。
When planning to implement health-related quality of life (HRQL) assessment in a multinational clinical trial, there are at least four general considerations: the natural history of the disease or condition, the characteristics of the population, the treatment under consideration, and the structure and function of the clinical trial organization. Each of these considerations must be addressed simultaneously when planning, implementing and analysing a cross-national clinical trial. There are five relevant polar components of the natural history of a given disease or condition: (1) time frame (acute versus chronic); (2) life threat (yes versus no); (3) symptomatology (present versus absent); (4) symptom expression (episodic versus constant); and (5) functional impact (present versus absent). Differences in population characteristics, (e.g., age, conditions, co-morbidity), embedded within any cross-national trial, must be addressed conceptually prior to initiating the trial, methodologically when planning implementation, and statistically after the collection of the data. In terms of treatment, issues such as adverse and positive effects and timing of effects must be considered. The methods entailed in planning, implementing and analysing HRQL data will depend upon the degree of centralization of personnel and resources within any given clinical trial. The range of possibilities runs from complete centralization, in which all planning and coordination of data collection and transmittal is done by one office, to complete decentralization, in which the work is distributed to participating sites and interested investigators. Finally, successful implementation of HRQL data collection is enhanced by heightening awareness of the importance of, and value in, assessing HRQL in clinical trials. The investigator embarking on a treatment trial can extend the outcome inquiry into broader areas of function and well-being than those defined by the more traditional symptom profiles, morbidity and mortality outcomes.