III期乳腺癌试验的方法学与伦理质量

Thoma Véronique, Bridoux Valérie, Lefebure Benoit, Wattiez Arnaud, Nisand Israël, Tuech Jean-Jacques

IRCAD/EITS, 1 Place de l'Hôpital- BP 426 -67091 Strasbourg Cedex, France.

Med Law. 2009 Dec;28(4):637-48.

OBJECTIVE

The gold standard of Evidence Based Medicine remains the randomised controlled trial (RCT), which is the only tool that allows an approach to the "therapeutic truth". To reach credible conclusions, these trials need to be perfect in methodological and ethical quality. The purpose of this study is to evaluate methodological quality (MQ), ethical quality (EQ) and compliance with ethical requirements in phase III randomized clinical trials of breast cancer treatment.

STUDY DESIGN

MQ was evaluated by the Jadad-scale and EQ by the Berdeu-score for all the randomised controlled clinical trials (RCT) (n = 137), published between January 2001 and December 2005 in 11 international journals.

RESULTS

Mean MQ was 9.88 +/- 1.43. MQ was insufficient (Jadad score pound 9) for 49 RCT (35,8%). Mean EQ was 0.45 +/- 0.12. Mean EQ for RCT with insufficient MQ (n = 49) was 0.43 +/- 0.12; Mean EQ for RCT with good MQ (Jadad score > 9)(n = 88) was 0.46 +/- 0.11. There was significant improvement in MQ depending on the year in which the study was started (p = 0.002). EQ was independent of the year of study's start (p = 0.134).There was no relationship between MQ or EQ and the number of patients included in the study (p = 0.53 and p = 0.1). There was a tendency towards correlation between MQ and EQ (p = 0.052), but the correlation between these two variables could not be considered as significant (r = 0.67). Informed consent from patients (ICP) was not obtained in 5.8% (n = 8) of the RCTs and the approval of a research ethics committee (REC) was not mentioned in 26.3% (n = 36) of the RCTs.

CONCLUSIONS

Good MQ and reporting of ethical requirements (EQ) reflects the respect shown to the patients during the whole research process. There are still deficiencies in EQ and MQ. Quality improvement requires education and appropriation by the scientific community, in particular, medical staff, of methodological and ethical basic rules concerning trials involving human beings.

目的

循证医学的金标准仍然是随机对照试验（RCT），这是唯一能够接近“治疗真相”的工具。为得出可靠的结论，这些试验在方法学和伦理质量方面需要尽善尽美。本研究的目的是评估乳腺癌治疗III期随机临床试验的方法学质量（MQ）、伦理质量（EQ）以及对伦理要求的遵守情况。

研究设计

采用雅达量表评估MQ，采用贝德量表评估EQ，对2001年1月至2005年12月期间发表在11种国际期刊上的所有随机对照临床试验（RCT）（n = 137）进行评估。

结果

平均MQ为9.88±1.43。49项RCT（35.8%）的MQ不足（雅达评分≤9）。平均EQ为0.45±0.12。MQ不足的RCT（n = 49）的平均EQ为0.43±0.12；MQ良好（雅达评分>9）的RCT（n = 88）的平均EQ为0.46±0.11。根据研究开始的年份，MQ有显著改善（p = 0.002）。EQ与研究开始年份无关（p = 0.134）。MQ或EQ与研究纳入的患者数量之间没有关系（p = 0.53和p = 0.1）。MQ和EQ之间存在一定的相关性趋势（p = 0.052），但这两个变量之间的相关性不能认为是显著的（r = 0.67）。5.8%（n = 8）的RCT未获得患者的知情同意书，26.3%（n = 36）的RCT未提及研究伦理委员会（REC）的批准。