Reporting on quality of life in randomised controlled trials: bibliographic study
Reporting on quality of life in randomised controlled trials: bibliographic study
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DOI：
10.1136/bmj.317.7167.1191
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发表时间：
1998-10-31
影响因子：
--
通讯作者：
Frankel, S
中科院分区：
文献类型：
--
作者：
Sanders, C;Egger, M;Frankel, S
目的检验随机对照试验中报告生活质量的频率和质量。设计检索1980~1997年Cochrane对照试验登记，以确定所有学科、肿瘤学和心血管内科报告生活质量的试验。对1993年至1996年发表的文章摘要的评估。使用标准化工具对完整报告样本进行评估。主要结果衡量生活质量报告的普及率。在报告生活质量的试验中研究的条件和干预措施。结果在1980-97年间，所有学科的试验报告的生活质量从0.63%上升到4.2%，癌症试验从1.5%上升到8.2%，心血管试验从0.34%上升到3.6%。在364篇摘要中，65%报告了药物干预。在61份完整报告的样本中，48份(72%)的作者使用了62份既定的生活质量量表。在15篇报告(22%)中，作者自行制定了测量方法，2篇(3%)方法不明确，38篇(57%)给出了应答率，31篇(46%)完整报道了所有条目和量表。结论在所有随机对照试验中，报告生活质量的比例不到5%，即使是癌症试验，这一比例也低于10%。在不同的研究中使用了过多的工具，方法和结果的报告往往不充分。临床试验研究中生活质量的测量和报告标准需要制定。
Objectives To examine the frequency and quality of reporting on quality of life in randomised controlled trials.Design Search of the Cochrane Controlled Trials Register 1980 to 1997 to identify trials from all disciplines, from oncology, and from cardiovascular medicine that reported on quality of life. Assessment of abstracts from articles published from 1993 to 1996. Assessment of a sample of full reports with a standardised instrument.Main outcome measures Prevalence of reporting on quality of life. Conditions and interventions studied in trials reporting on quality of life. Quality of reporting on quality of life.Results During 1980-97 reporting on quality of life increased from 0.63% to 4.2% for trials from all disciplines, from 1.5% to 8.2% for cancer trials, and from 0.34% to 3.6% for cardiovascular trials. Of 364 abstracts, 65% reported on drug interventions. Of a sample of 61 full reports, authors of 48 (72%) used 62 established quality of life instruments. In 15 reports (22%) authors developed their own measures, and in 2 (3%) methods were unclear Response rates were given in 38 (57%), and complete reporting on all items and scales occurred in 31 (46%).Conclusions Less than 5% of all randomised controlled trials reported on quality of life, and this proportion was below 10% even for cancer trials. A plethora of instruments was used in different studies, and the reporting of methods and results was often inadequate. Standards for the measurement and reporting of quality of life in clinical trials research need to be developed.