Ntala Chara, Birmpili Panagiota, Worth Allison, Anderson Niall H, Sheikh Aziz
University of Patras, Medical School, University Campus, PC 26504, Rio, Patras, Greece.
Prim Care Respir J. 2013 Dec;22(4):417-24. doi: 10.4104/pcrj.2013.00089.
There are concerns about the reporting quality of asthma trials.
To describe the reporting of contemporary asthma trials and to identify factors associated with better reporting quality.
Two reviewers independently searched MEDLINE for randomised controlled trials (RCTs) of asthma published between January 2010 and July 2012 in leading generalist and specialist journals. We calculated the proportion of trials that adequately reported each Consolidated Standards of Reporting Trials (CONSORT) checklist item and an overall quality score for each trial. Factors associated with better reporting quality were investigated.
Thirty-five RCTs satisfied our eligibility criteria. Four trials adequately reported <50% of the items, 15 adequately reported 50-60% of items, and 16 adequately reported >60% of items. Seventeen of the 38 CONSORT items were consistently well reported in more than two-thirds of the articles. In contrast, nine items were poorly reported in more than half the trials - namely, identification as a randomised trial in the title (40.0%), an adequate structured summary/abstract (48.6%), details of eligibility criteria (34.3%), recruitment (48.6%), randomisation procedures (22.9%), intervention (38.5%), harms (34.3%), the funding source (45.7%), and access to the full trial protocol (17.1%). Studies led by teams in high-income country settings were associated with better quality of reporting (relative risk=1.33, 95% CI 1.09 to 1.64).
The quality of reporting in contemporary asthma literature remains suboptimal. We have identified important areas in which reporting quality needs to be improved.
人们对哮喘试验的报告质量存在担忧。
描述当代哮喘试验的报告情况，并确定与更好报告质量相关的因素。
两名综述作者独立检索MEDLINE，以查找2010年1月至2012年7月在主要的综合医学和专科医学期刊上发表的哮喘随机对照试验（RCT）。我们计算了充分报告每项《报告试验的统一标准》（CONSORT）清单条目的试验比例以及每项试验的总体质量得分。对与更好报告质量相关的因素进行了调查。
35项RCT符合我们的纳入标准。4项试验充分报告的条目不到50%，15项试验充分报告的条目为50%至60%，16项试验充分报告的条目超过60%。38项CONSORT条目中有17项在超过三分之二的文章中得到了一致良好的报告。相比之下，有9项条目在超过一半的试验中报告不佳，即标题中注明为随机试验（40.0%）、有充分的结构化摘要（48.6%）、纳入标准的详细信息（34.3%）、招募情况（48.6%）、随机化程序（22.9%）、干预措施（38.5%）、不良事件（34.3%）、资金来源（45.7%）以及获取完整试验方案的途径（17.1%）。由高收入国家团队主导的研究与更好的报告质量相关（相对风险=1.33，95%置信区间1.09至1.64）。
当代哮喘文献的报告质量仍未达到最佳。我们已经确定了报告质量需要改进的重要领域。
