Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
Addiction. 2020 Jun;115(6):1172-1179. doi: 10.1111/add.14902. Epub 2020 Jan 16.
Selective outcome reporting occurs when trialists pre-specify primary and secondary outcomes during trial planning but alter the definitions in the published report. Here, we investigate selective outcome reporting in published addiction randomized controlled trials (RCTs) and evaluate whether particular funding sources are associated with an increased likelihood of selective outcome reporting.
We conducted a cross-sectional study of published addiction clinical trials. A PubMed search was performed to identify RCTs in addiction journals from 2013 to 2017. Included studies used a randomized design to address one of the following topics: (1) drug, alcohol and tobacco addiction prevention, (2) stabilization following excessive use of a substance, (3) relapse prevention or (4) recovery maintenance.
Single-center, medical research institution.
Our sample included 162 RCTs that were prospectively registered with a clearly defined primary outcome.
We extracted the following items from addiction RCTs: journal, funding source, trial registry number (if included), sample size, dates of subject enrollment, whether primary and secondary outcomes were denoted, all published outcomes, P-value for all outcomes and whether authors mentioned any deviations from the trial protocol as it related to RCT outcomes.
In total, 47 of 162 RCTs (29.0%) had at least one major discrepancy between the trial registry and published RCT. Overall, these 47 RCTs included 54 major discrepancies. The most common major discrepancy was demotion of a primary registered outcome (19/54, 35.2%). The majority of RCTs (132/162, 81.5%) were funded from public sources. Additionally, 166 RCTs were excluded from our sample because registration could not be confirmed.
There is evidence suggestive of selective outcome reporting in addiction randomized controlled trials (RCTs). The most common major discrepancies pertained to the primary outcome.
当试验设计者在试验规划时预先指定主要和次要结局，但在发表报告中改变定义时，就会发生选择性结局报告。在这里，我们调查了已发表的成瘾性随机对照试验（RCT）中的选择性结局报告，并评估了特定的资金来源是否与选择性结局报告的可能性增加有关。
我们对已发表的成瘾性临床研究进行了横断面研究。通过 PubMed 搜索，从 2013 年至 2017 年，在成瘾期刊中确定了 RCTs。纳入的研究使用随机设计来解决以下一个主题：（1）药物、酒精和烟草成瘾预防，（2）物质过量使用后的稳定化，（3）复发预防或（4）康复维持。
单中心，医学研究机构。
我们的样本包括 162 项前瞻性注册的具有明确主要结局的 RCT。
我们从成瘾性 RCT 中提取了以下项目：期刊、资金来源、试验注册编号（如果包括）、样本量、研究对象入组日期、主要和次要结局是否表示、所有已发表的结局、所有结局的 P 值以及作者是否提到与 RCT 结局相关的试验方案的任何偏差。
在总共 162 项 RCT 中，有 47 项（29.0%）在试验注册和已发表的 RCT 之间至少有一个主要差异。总体而言，这 47 项 RCT 包括 54 个主要差异。最常见的主要差异是主要注册结局的降级（19/54，35.2%）。大多数 RCT（132/162，81.5%）是由公共资金资助的。此外，由于无法确认注册，166 项 RCT 被排除在我们的样本之外。
有证据表明成瘾性 RCT 存在选择性结局报告。最常见的主要差异与主要结局有关。
