Miguel Ramón San, López-González Ana María, Sanchez-Iriso Eduardo, Mar Javier, Cabasés Juan M
Pharmacy Department, Hospital Santa Bárbara - SACYL, Paseo Santa Bárbara, Soria 42002, Spain.
Pharm World Sci. 2008 Apr;30(2):154-60. doi: 10.1007/s11096-007-9152-9. Epub 2007 Aug 25.
Efficacy estimations of drug clinical trials have been based on clinical measurements and survival rates. However, advances in psychometric techniques have allowed to incorporate a new dimension based on quality of life. Questionnaires aimed at measuring patients' health status outlook, now enable us to quantify the loss of quality of life caused by disease and the improvement that can be achieved by pharmacological treatments. The Aim of this study is to make a quantitative evaluation of the use of health related quality of life (HRQL) measures in drug clinical trials.
A systematic review was performed, in duplicate, of the five journals with highest contribution to the ACP Journal Club, i.e. New England Journal of Medicine, JAMA, The Lancet, Annals of Internal Medicine and the British Medical Journal. HRQL measures were evaluated in published articles referring to drug clinical trials.
We identified 193 articles that reported the results of clinical trials, of which 28 included QOL measures as secondary end points and two as primary end points: in total, these comprised 16% of the articles analysed. Discussion Without considering the relevance of HRQL measures as a tool in the allocation of resources, it should be included as a health outcome dimension in drug clinical trials. The absence of this evaluation in studies about chronic diseases that affects patients' daily life activities would not be justified.
HRQL measures are not used on a regular basis in drug clinical trials that are reported in the relevant literature. Systematic incorporation of QOL measures into clinical trials would make it possible to measure the benefit obtained from drug treatments taking into account the patients' perceptions. Moreover, it would encourage the development of prospective cost-effectiveness studies with patient recorded data in the context of clinical trials. Our findings have a direct impact on practice. Being conscious of the low use of HRQL in clinical trials, it could contribute to increase the demand for these measures by health care professionals. The manuscript is also a useful tool to identify where basic concepts about HRQL measures can be found.
药物临床试验的疗效评估一直基于临床测量和生存率。然而，心理测量技术的进步使得能够纳入基于生活质量的新维度。旨在测量患者健康状况前景的问卷调查，现在使我们能够量化疾病导致的生活质量损失以及药物治疗所能实现的改善。本研究的目的是对药物临床试验中健康相关生活质量（HRQL）测量的使用进行定量评估。
对向《内科学年鉴杂志俱乐部》投稿量最高的五本期刊，即《新英格兰医学杂志》《美国医学会杂志》《柳叶刀》《内科学年鉴》和《英国医学杂志》进行了重复的系统综述。在提及药物临床试验的已发表文章中评估HRQL测量。
我们识别出193篇报告临床试验结果的文章，其中28篇将生活质量测量作为次要终点，2篇作为主要终点：总体而言，这些文章占所分析文章的16%。讨论不考虑HRQL测量作为资源分配工具的相关性，它应作为药物临床试验中的健康结局维度被纳入。在影响患者日常生活活动的慢性病研究中缺乏这种评估是不合理的。
在相关文献报道的药物临床试验中，HRQL测量并未得到常规使用。将生活质量测量系统地纳入临床试验将有可能在考虑患者认知的情况下衡量药物治疗所获得的益处。此外，这将鼓励在临床试验背景下开展基于患者记录数据的前瞻性成本效益研究。我们的发现对实践有直接影响。意识到HRQL在临床试验中的低使用率，可能有助于增加医疗保健专业人员对这些测量的需求。该手稿也是一个有用的工具，可用于确定在哪里可以找到关于HRQL测量的基本概念。
