Medical Writing Europe, Boehringer Ingelheim Pharma, Biberach, Germany.
Data Disclosure Governance & Standards, UCB BioSciences GmbH, Monheim, Germany.
PLoS One. 2020 May 29;15(5):e0233294. doi: 10.1371/journal.pone.0233294. eCollection 2020.
ClinicalTrials.gov was started with the intention to create a consumer-friendly database for patients and others in search of information on clinical trials. However, there is no research on whether the content of ClinicalTrials.gov aligns with patient preferences. The TransCelerate Clinical Research Access & Information Exchange Initiative convened patient advisory boards and conducted a global online survey (N = 1070) to determine patient preferences when searching for clinical trials for participation. Patient feedback and ClinicalTrials.gov guidance documents were used to construct instruments to assess patient focus and guidance adherence of the Brief Title (a short lay title of the clinical trial) and Brief Summary (a high-level summary of study features) data fields in a representative sample (N = 346) of ClinicalTrials.gov records of interventional trials. When searching for clinical trials, survey participants rated condition (66.4%), trial location (57.0%), trial dates (52.9%), age and gender (48.6%), and health measurements (i.e., what the study measures) (45.5%) as the most important items. When presented with a list of trials from an initial search, participants saw condition, brief summary, study drug name, and brief title as the most helpful items. In a Brief Title, they wanted condition, health measurements, participant age, and study drug name. For Brief Summaries, participants preferred additional information on treatment duration, condition, study goal, health measurements, and frequency of visits. The assessment of patient focus in a representative sample of current ClinicalTrials.gov records showed that patient focus was underdeveloped as study records achieved only 52% (brief titles) and 50% (brief summaries) of the best possible score. The analysis of adherence to ClinicalTrials.gov guidance showed better scores (brief titles 69%, brief summaries 66%). We identified key information elements for registry users when evaluating clinical trials for participation. We found that aspects of patient focus are not common in current ClinicalTrials.gov entries. To support more user-friendly study records, we developed a tool to assess the quality of the plain language fields in study records prior to submission.
ClinicalTrials.gov 的创建初衷是为患者和其他寻求临床试验信息的人创建一个易于使用的数据库。然而，目前还没有研究表明 ClinicalTrials.gov 的内容是否符合患者的偏好。TransCelerate 临床研究获取与信息交流倡议召集了患者顾问委员会，并进行了一项全球在线调查（N=1070），以确定患者在搜索参与临床试验时的偏好。患者反馈和 ClinicalTrials.gov 指导文件被用于构建工具，以评估代表性样本（N=346）中临床试验记录的简短标题（临床试验的简短通俗标题）和简短摘要（研究特征的高级摘要）数据字段的患者关注和指导遵守情况。在搜索临床试验时，调查参与者将病情（66.4%）、试验地点（57.0%）、试验日期（52.9%）、年龄和性别（48.6%）以及健康测量值（即研究测量的内容）（45.5%）评为最重要的项目。当从初始搜索中呈现一系列试验时，参与者认为病情、简短摘要、研究药物名称和简短标题是最有帮助的项目。在简短标题中，他们希望包含病情、健康测量值、参与者年龄和研究药物名称。对于简短摘要，参与者更喜欢关于治疗持续时间、病情、研究目标、健康测量值和就诊频率的更多信息。对当前 ClinicalTrials.gov 记录的代表性样本进行的患者关注评估表明，由于研究记录仅达到最佳可能得分的 52%（简短标题）和 50%（简短摘要），因此患者关注度不够。对 ClinicalTrials.gov 指导的遵守情况进行分析显示，得分更好（简短标题 69%，简短摘要 66%）。我们确定了注册用户在评估参与临床试验时的关键信息要素。我们发现，当前 ClinicalTrials.gov 条目没有常见的患者关注方面。为了支持更便于用户使用的研究记录，我们开发了一种工具，用于在提交之前评估研究记录中通俗易懂字段的质量。
