Fleiner Franca, Fritsche Lutz, Glander Petra, Neumayer Hans-H, Budde Klemens
Department of Nephrology, Charité Campus Mitte, Berlin, Germany.
Transplantation. 2006 Mar 15;81(5):655-9. doi: 10.1097/01.tp.0000214933.73927.4e.
Prevention of acute rejection still is an important endpoint in randomized controlled trials. Poor study reporting may create confusion and render decision-making difficult. The present study thoroughly analyses the presentation and definition of rejection in reports on large multicenter immunosuppressive trials published in the field of renal transplantation.
Publications of large immunosuppression trials in kidney transplantation were identified by a predefined search strategy. The reported acute and biopsy-proven acute rejection (BPAR) episodes and additional information on number of patients recruited, publication year, impact factor, definition of acute rejection and the reporting of efficacy analyses were extracted. All reports were scanned for (a) at what point and (b) for which signs or reasons a biopsy was performed.
Eight of 41 (19.5%) papers investigating rejection rates reported a sufficient definition of acute rejection. Twenty-eight of 41 (68.3%) presented more than one rejection rate and were published in significantly higher impact journals. The absolute difference between clinical rejection and BPAR had a median of 6.5% and a wide range (0-16.9%). Efficacy analysis was presented in all but four (90.2%) reports. Thirteen of 35 (37.1%) papers did report the timing of the biopsies and 25 of 35 (71.4%) publications gave specifications of when a biopsy sample should be taken.
The requirements of proper reporting of rejection episodes are not fulfilled in most of the publications and the use of many different terms for the description of rejection rates is confusing at present. Our comprehensive review clearly demonstrates the need for improved and standardized reporting of rejection episodes and we suggest to report both acute rejection and BPAR.
在随机对照试验中，预防急性排斥反应仍然是一个重要的终点。研究报告不佳可能会造成混乱并使决策变得困难。本研究全面分析了肾移植领域发表的大型多中心免疫抑制试验报告中排斥反应的呈现和定义。
通过预定义的搜索策略确定肾移植大型免疫抑制试验的出版物。提取报告的急性和活检证实的急性排斥反应（BPAR）事件以及关于招募患者数量、发表年份、影响因子、急性排斥反应定义和疗效分析报告的其他信息。对所有报告进行扫描，以确定（a）何时以及（b）进行活检的体征或原因。
在41篇研究排斥反应率的论文中，有8篇（19.5%）报告了急性排斥反应的充分定义。41篇中有28篇（68.3%）呈现了不止一种排斥反应率，并且发表在影响因子显著更高的期刊上。临床排斥反应与BPAR之间的绝对差异中位数为6.5%，范围较广（0 - 16.9%）。除4篇（90.2%）报告外，所有报告均进行了疗效分析。35篇论文中有13篇（37.1%）确实报告了活检时间，35篇出版物中有25篇（71.4%）给出了活检样本采集时间的具体说明。
大多数出版物未满足排斥反应事件正确报告的要求，目前使用许多不同术语描述排斥反应率令人困惑。我们的全面综述清楚地表明需要改进和标准化排斥反应事件的报告，我们建议同时报告急性排斥反应和BPAR。
