Strippoli Giovanni F M, Craig Jonathan C, Schena Francesco P
NHMRC Centre of Clinical Research Excellence in Renal Medicine, The Children's Hospital at Westmead, School of Public Health, University of Sydney, Australia.
J Am Soc Nephrol. 2004 Feb;15(2):411-9. doi: 10.1097/01.asn.0000100125.21491.46.
Randomized controlled trials (RCT) are the optimal study design to answer intervention questions. The authors evaluated the number, quality, and coverage of RCT in nephrology. MEDLINE was searched using the relevant medical subject headings for nephrology and 12 major specialties in internal medicine, limited by "randomized controlled trial" as a publication type. A random selection of 160 RCT in nephrology (40 for each decade) published since 1966 and an additional 270 RCT from ongoing or published Cochrane systematic reviews in various areas of nephrology, dialysis, and transplantation were evaluated for quality of reporting using standard criteria. The number of RCT published in nephrology from 1966 to 2002 (2779) is fewer than all other specialties of internal medicine (range: 5335 in hematology to 27109 in cardiology) with the proportion of all citations which are RCT being the third lowest (1.15%). There has been an increase in both indices from 1966 to 1996, but not at a greater rate than other specialties, and there has been no increase over the past 5 yr. Some areas of nephrology, in particular glomerulonephritis, are clear outliers with very low numbers of RCT to guide clinical decision-making. Overall the quality of RCT reporting in nephrology is low and has not improved over the past 30 yr with unclear allocation concealment (89%), lack of reported blinding of outcome assessors (92%), and failure to perform "intention-to-treat analysis" (50%) particularly frequent. The challenges of improving the quality and quantity of trials in nephrology are substantial, but they can be overcome by using standard guidelines and checklists for trial reporting, greater attention to the trial methods and not just the results, involving experts in trial design and reporting, multicenter collaboration, and larger and simpler trials.
随机对照试验（RCT）是回答干预问题的最佳研究设计。作者评估了肾脏病学领域随机对照试验的数量、质量和覆盖范围。使用肾脏病学及内科12个主要专科的相关医学主题词在MEDLINE数据库中进行检索，检索结果限定为出版类型为“随机对照试验”的文献。随机选取了自1966年以来发表的160项肾脏病学随机对照试验（每个十年40项），并从正在进行或已发表的关于肾脏病学、透析和移植各个领域的Cochrane系统评价中另外选取了270项随机对照试验，使用标准标准评估报告质量。1966年至2002年期间肾脏病学领域发表的随机对照试验数量（2779项）少于内科的所有其他专科（范围：血液学5335项至心脏病学27109项），随机对照试验在所有引用文献中所占比例为第三低（1.15%）。从1966年到1996年，这两个指标均有所增加，但增速并不高于其他专科，且在过去5年中没有增长。肾脏病学的某些领域，特别是肾小球肾炎，明显是例外情况，用于指导临床决策的随机对照试验数量非常少。总体而言，肾脏病学随机对照试验报告的质量较低，在过去30年中没有改善，分配隐藏不清楚（89%）、未报告结果评估者的盲法（92%）以及未进行“意向性分析”（50%）的情况尤为常见。提高肾脏病学试验的质量和数量面临诸多挑战，但可以通过使用试验报告的标准指南和清单、更加关注试验方法而非仅仅结果、让专家参与试验设计和报告、多中心合作以及开展更大且更简单的试验来克服。
