Abstract：
Randomized controlled trials (RCTs) provide high-quality evidence for treatment efficacy, but many RCTs remain unpublished. The objective of this study was to describe the proportion of unpublished RCTs in five rheumatic diseases and to identify factors associated with publication.
Registered RCTs for five rheumatic diseases (SLE, vasculitis, spondyloarthritis, SS and PsA) with over 30 months since study completion were identified using ClinicalTrials.gov. Index publications were identified by NCT ID numbers and structured text searches of publication databases. The results of unpublished studies were identified in abstracts and press releases; reasons for non-publication were assessed by surveying corresponding authors.
Out of 203 studies that met eligibility criteria, 17.2% remained unpublished, representing data from 4281 trial participants. Higher proportions of published trials were phase 3 RCTs (57.1% vs 28.6% unpublished, P < 0.05) or had a positive primary outcome measure (64.9% vs 25.7% unpublished, P < 0.001). In a multivariable Cox proportional hazards model, a positive outcome was independently associated with publication (hazard ratio 1.55; 95% CI: 1.09, 2.22). Corresponding authors of 10 unpublished trials cited ongoing preparation of the manuscript (50.0%), sponsor/funder issues (40.0%) and unimportant/negative result (20.0%) as reasons for lack of publication.
Nearly one in five RCTs in rheumatology remain unpublished 2 years after trial completion, and publication is associated with positive primary outcome measures. Efforts to encourage universal publication of rheumatology RCTs and reanalysis of previously unpublished trials should be undertaken.
Registered RCTs for five rheumatic diseases (SLE, vasculitis, spondyloarthritis, SS and PsA) with over 30 months since study completion were identified using ClinicalTrials.gov. Index publications were identified by NCT ID numbers and structured text searches of publication databases. The results of unpublished studies were identified in abstracts and press releases; reasons for non-publication were assessed by surveying corresponding authors.
Out of 203 studies that met eligibility criteria, 17.2% remained unpublished, representing data from 4281 trial participants. Higher proportions of published trials were phase 3 RCTs (57.1% vs 28.6% unpublished, P < 0.05) or had a positive primary outcome measure (64.9% vs 25.7% unpublished, P < 0.001). In a multivariable Cox proportional hazards model, a positive outcome was independently associated with publication (hazard ratio 1.55; 95% CI: 1.09, 2.22). Corresponding authors of 10 unpublished trials cited ongoing preparation of the manuscript (50.0%), sponsor/funder issues (40.0%) and unimportant/negative result (20.0%) as reasons for lack of publication.
Nearly one in five RCTs in rheumatology remain unpublished 2 years after trial completion, and publication is associated with positive primary outcome measures. Efforts to encourage universal publication of rheumatology RCTs and reanalysis of previously unpublished trials should be undertaken.
摘要：
目的：随机对照试验（RCTs）为治疗效果提供高质量的证据，但许多RCT仍未发表。这项研究的目的是描述5种风湿性疾病中未发表的RCTs的比例，并确定与发表相关的因素。
方法：5种风湿性疾病的注册RCT（系统性红斑狼疮，血管炎,脊柱关节炎,干燥综合征,和银屑病关节炎)，自研究完成以来超过30个月，使用ClinicalTrials.gov。通过NCTID号和出版物数据库的结构化文本搜索来识别索引出版物。在摘要和新闻稿中确定了未发表研究的结果；通过调查相应作者来评估未发表的原因。
结果：在满足资格标准的203项研究中，17.2%仍未发表，代表4,281名试验参与者的数据。已发表的试验比例较高的是3期随机对照试验(57.1%vs28.6%未发表，p<0.05）或具有阳性的主要结局指标（64.9％vs25.7％未发表，p<0.001)。在多变量cox比例风险模型中，阳性结局与发表独立相关(HR1.55,CI1.09-2.22).10个未发表的试验的相应作者引用了正在进行的手稿准备（50.0％），发起人/出资人问题（40.0%），以及不重要/阴性结果(20.0%)是缺乏出版的原因。
结论：在完成试验两年后，近五分之一的风湿病随机对照试验仍未发表。和出版物与积极的主要结果指标相关。应努力鼓励风湿病随机对照试验的普遍出版和以前未发表的试验的重新分析。
方法：5种风湿性疾病的注册RCT（系统性红斑狼疮，血管炎,脊柱关节炎,干燥综合征,和银屑病关节炎)，自研究完成以来超过30个月，使用ClinicalTrials.gov。通过NCTID号和出版物数据库的结构化文本搜索来识别索引出版物。在摘要和新闻稿中确定了未发表研究的结果；通过调查相应作者来评估未发表的原因。
结果：在满足资格标准的203项研究中，17.2%仍未发表，代表4,281名试验参与者的数据。已发表的试验比例较高的是3期随机对照试验(57.1%vs28.6%未发表，p<0.05）或具有阳性的主要结局指标（64.9％vs25.7％未发表，p<0.001)。在多变量cox比例风险模型中，阳性结局与发表独立相关(HR1.55,CI1.09-2.22).10个未发表的试验的相应作者引用了正在进行的手稿准备（50.0％），发起人/出资人问题（40.0%），以及不重要/阴性结果(20.0%)是缺乏出版的原因。
结论：在完成试验两年后，近五分之一的风湿病随机对照试验仍未发表。和出版物与积极的主要结果指标相关。应努力鼓励风湿病随机对照试验的普遍出版和以前未发表的试验的重新分析。
