Bath F J, Owen V E, Bath P M
Stroke Group, Department of Medicine, King's College School of Medicine and Dentistry, London, UK
Stroke. 1998 Oct;29(10):2203-10. doi: 10.1161/01.str.29.10.2203.
Several studies have shown that the quality of reporting of trials throughout medicine is variable and often poor. We report on the quality of the final reports of randomized controlled trials (RCTs) of drug therapies assessed in acute stroke.
English-language reports published up to the end of 1996 relating to completed RCTs in acute stroke were identified from electronic searches of the Cochrane Stroke Review Group database of stroke trials and the Cochrane Controlled Trials Register (CD-ROM issue 1, 1997, of the Cochrane Library). Report quality was assessed with the 33 criteria of the CONSORT statement and 53 additional factors relevant to acute stroke or trials in general. Trial quality was also assessed with a 7-point scale.
Up to 1996, 114 RCTs were published which involved 20 536 patients (median, 80; range, 16 to 1267 per trial); 39 (35.5%) of these were published in Stroke. The median total report quality was 40/86 (range, 15 to 61) for all criteria and 19/33 (range, 9 to 29) for the CONSORT criteria alone. Although adequate information was given in the introduction and discussion sections of most reports, insufficient details were given on methods, assignment of patients to treatment groups, statistical analyses, the prevalence of risk factors, and assessment of outcomes. Report quality has improved between 1956 and 1996 (Spearman correlation coefficient [rs], 0.575; 95% confidence interval [CI], 0. 439 to 0.685) and was superior in large trials (rs=0.434; 95% CI, 0. 274 to 0.571). Although report quality was related to trial quality (rs=0.675; 95% CI, 0.563 to 0.763), it was not related to journal impact factor (rs=0.170; 95% CI, -0.015 to 0.344). Trials with a positive outcome tended to be less well reported than those with a neutral or negative outcome (rs=-0.192; 95% CI, -0.351 to -0.011).
The overall quality of study reports for parallel group RCTs in acute stroke is poor but appears to be improving with time and in parallel with an increase in trial size. Reports often lack detailed information on the methods of randomization, concealment of allocation, and statistical analysis, all factors which can, if undertaken poorly, affect trial results and validity. It is vital that future trials are adequately reported; we believe that authors should follow the CONSORT guidelines and that referees and editors should ensure this happens.
多项研究表明，整个医学领域试验报告的质量参差不齐，且往往较差。我们报告了急性卒中药物治疗随机对照试验（RCT）最终报告的质量。
通过对Cochrane卒中综述组卒中试验数据库和Cochrane对照试验注册库（Cochrane图书馆1997年第1期光盘版）进行电子检索，确定截至1996年底发表的有关急性卒中已完成RCT的英文报告。采用CONSORT声明的33条标准以及另外53条与急性卒中或一般试验相关的因素对报告质量进行评估。试验质量也采用7分制进行评估。
截至1996年，共发表了114项RCT，涉及20536例患者（中位数为80例；范围为每项试验16至1267例）；其中39项（35.5%）发表在《卒中》杂志上。所有标准下报告的总质量中位数为40/86（范围为15至61），仅CONSORT标准下为19/33（范围为9至29）。尽管大多数报告的引言和讨论部分提供了足够的信息，但在方法、患者分配至治疗组、统计分析、危险因素的患病率以及结局评估方面的细节不足。1956年至1996年间报告质量有所提高（Spearman相关系数[rs]为0.575；95%置信区间[CI]为0.439至0.685），且在大型试验中质量更高（rs = 0.434；95%CI为0.274至0.571）。虽然报告质量与试验质量相关（rs = 0.675；95%CI为0.563至0.763），但与期刊影响因子无关（rs = 0.170；95%CI为 - 0.015至0.344）。有阳性结果的试验报告往往不如有中性或阴性结果的试验报告（rs = - 0.192；95%CI为 - 0.351至 - 0.011）。
急性卒中平行组RCT研究报告的总体质量较差，但似乎随着时间推移以及试验规模的增加而有所改善。报告通常缺乏关于随机化方法、分配隐藏和统计分析的详细信息，所有这些因素如果执行不当都可能影响试验结果和有效性。未来的试验充分报告至关重要；我们认为作者应遵循CONSORT指南，审稿人和编辑应确保这一点得以实现。
