Fletcher A E, Bulpitt C J
Division of Geriatric Medicine, Royal Postgraduate Medical School, Hammersmith Hospital, London, UK.
Cardiology. 1988;75 Suppl 1:41-52. doi: 10.1159/000174444.
This article discusses some of the issues involved in the use of quality of life methods to evaluate treatment, primarily in trials of cardiovascular disease. The choice of aspects to measure is influenced by the severity and nature of the disease, the expected benefits and adverse effects of treatment and pragmatic considerations such as the length of the trial, and availability of the methods. The choice of specific instruments should take account of good measurement criteria such as validity and reliability, and, most importantly, sensitivity to the effects of treatment. The advantages and disadvantages of interviewer and self-completed questionnaires are discussed. The choice of respondent is primarily the patient. In some circumstances it may be appropriate to also include family members, either for their views on the patient, or for an assessment of their own quality of life as this may also be disrupted. Withdrawals are a major problem in the analysis of all trial results. The inclusion of a Health Index is one method of obtaining quality of life scores from patients who withdraw or die. The interpretation of quality of life results from trials is not simple, for example, the benefit of trial inclusion needs to be distinguished from the effect of treatment. Moreover, changes in quality of life scores should correspond to changes in the patients' own experiences of their daily lives.
本文讨论了使用生活质量方法评估治疗所涉及的一些问题，主要是在心血管疾病试验中。测量方面的选择受疾病的严重程度和性质、治疗的预期益处和不良反应以及试验时长和方法可用性等实际考虑因素的影响。特定工具的选择应考虑有效性和可靠性等良好的测量标准，最重要的是要考虑对治疗效果的敏感性。文中讨论了访谈式问卷和自填式问卷的优缺点。受访者主要为患者。在某些情况下，纳入家庭成员也可能是合适的，要么获取他们对患者的看法，要么评估他们自身的生活质量，因为这也可能受到影响。失访是所有试验结果分析中的一个主要问题。纳入健康指数是从失访或死亡患者那里获取生活质量得分的一种方法。试验中生活质量结果的解读并不简单，例如，需要区分纳入试验的益处和治疗效果。此外，生活质量得分的变化应与患者自身日常生活体验的变化相对应。
