School of Medicine, University of St Andrews, St Andrews, UK
School of Medicine, University of St Andrews, St Andrews, UK.
BMJ Open. 2023 Jul 26;13(7):e072996. doi: 10.1136/bmjopen-2023-072996.
To understand: if professionals, citizens and patients can locate UK healthcare professionals' statements of declarations of interests, and what citizens understand by these.
The study sample included two groups of participants in three phases. First, healthcare professionals working in the public domain (health professional participants, HPP) were invited to participate. Their conflicts and declarations of interest were searched for in publicly available data, which the HPP checked and confirmed as the 'gold standard'. In the second phase, laypeople, other healthcare professionals and healthcare students were invited to complete three online tasks. The first task was a questionnaire about their own demographics. The second task was questions about doctors' conflicts of interest in clinical vignette scenarios. The third task was a request for each participant to locate and describe the declarations of interest of one of the named healthcare professionals identified in the first phase, randomly assigned. At the end of this task, all lay participants were asked to indicate willingness to be interviewed at a later date. In the third phase, each lay respondent who was willing to be contacted was invited to a qualitative interview to obtain their views on the conflicts and declaration of interest they found and their meaning.
Online, based in the UK.
13 public-facing health professionals, 379 participants (healthcare professionals, students and laypeople), 21 lay interviewees.
(1) Participants' level of trust in professionals with variable conflicts of interest, as expressed in vignettes, (2) participants' ability to locate the declarations of interest of a given well-known healthcare professional and (3) laypeoples' understanding of healthcare professionals declarations and conflicts of interest.
In the first phase, 13 health professionals (HPP) participated and agreed on a 'gold standard' of their declarations. In the second phase, 379 citizens, patients, other healthcare professionals and students participated. Not all completed all aspects of the research. 85% of participants thought that knowing about professional declarations was definitely or probably important, but 76.8% were not confident they had found all relevant information after searching. As conflicts of interest increased in the vignettes, participants trusted doctors less. Least trust was associated with doctors who had not disclosed their conflicts of interest. 297 participants agreed to search for the HPP 'gold standard' declaration of interest, and 169 reported some data. Of those reporting any findings, 61 (36%) located a relevant link to some information deemed fit for purpose, and 5 (3%) participants found all the information contained in the 'gold standard'. In the third phase, qualitative interviews with 21 participants highlighted the importance of transparency but raised serious concerns about how useful declarations were in their current format, and whether they could improve patient care. Unintended consequences, such as the burden for patients and professionals to use declarations were identified, with participants additionally expressing concerns about professional bias and a lack of insight over conflicts. Suggestions for improvements included better regulation and organisation, but also second opinions and independent advice where conflicts of interest were suspected.
Declarations of interest are important and conflicts of interest concern patients and professionals, particularly in regard to trust in decision-making. If declarations, as currently made, are intended to improve transparency, they do not achieve this, due to difficulties in locating and interpreting them. Unintended consequences may arise if transparency alone is assumed to provide management of conflicts. Increased trust resulting from transparency may be misplaced, given the evidence on the hazards associated with conflicts of interest. Clarity about the purposes of transparency is required. Future policies may be more successful if focused on reducing the potential for negative impacts of conflicts of interest, rather than relying on individuals to locate declarations and interpret them.
The protocol was pre-registered at https://osf.io/e7gtq.
了解专业人员、市民和患者是否能够找到英国医疗保健专业人员的利益申报声明，以及市民对这些声明的理解。
研究样本包括三个阶段的两组参与者。首先，邀请在公共领域工作的医疗保健专业人员（卫生专业人员参与者，HPP）参加。他们的冲突和利益申报在公开数据中进行了搜索，HPP 对这些数据进行了检查并确认作为“黄金标准”。在第二阶段，邀请了非专业人士、其他医疗保健专业人员和医疗保健学生完成三个在线任务。第一项任务是关于他们自己人口统计数据的问卷。第二项任务是关于医生在临床病例场景中利益冲突的问题。第三项任务是要求每位参与者找到并描述第一阶段随机分配的一名指定医疗保健专业人员的利益申报。在任务结束时，所有非专业参与者都被要求表示愿意在以后的日期接受采访。在第三阶段，每位愿意联系的非专业受访者都被邀请参加定性访谈，以了解他们对发现的利益冲突和申报以及他们的意义的看法。
基于英国的在线。
13 名面向公众的卫生专业人员，379 名参与者（医疗保健专业人员、学生和非专业人士），21 名非专业访谈者。
（1）在病例中，参与者对有不同利益冲突的专业人员的信任程度，（2）参与者找到给定知名医疗保健专业人员的利益申报的能力，以及（3）非专业人士对医疗保健专业人员的申报和利益冲突的理解。
在第一阶段，13 名卫生专业人员（HPP）参加了研究并就他们的“黄金标准”申报达成一致。在第二阶段，有 379 名市民、患者、其他医疗保健专业人员和学生参加了研究。并非所有参与者都完成了所有研究方面。85%的参与者认为了解专业人员的申报绝对或可能很重要，但 76.8%的参与者在搜索后并不自信他们已经找到了所有相关信息。随着病例中利益冲突的增加，参与者对医生的信任度降低。对医生不信任的程度与未披露利益冲突的医生相关。297 名参与者同意搜索 HPP 的“黄金标准”利益申报，169 名参与者报告了一些数据。在报告任何发现的参与者中，有 61 名（36%）找到了一些被认为适合目的的相关链接信息，有 5 名（3%）参与者找到了“黄金标准”中包含的所有信息。在第三阶段，对 21 名参与者进行的定性访谈强调了透明度的重要性，但对当前形式的申报在改善患者护理方面的有用性提出了严重担忧，以及它们是否能够改善患者护理。参与者还表示担心申报可能会带来一些意外后果，例如患者和专业人员使用申报的负担，以及对专业偏见和冲突缺乏洞察力。改进的建议包括更好的监管和组织，但也包括在怀疑有利益冲突时寻求第二意见和独立建议。
利益申报很重要，利益冲突令患者和专业人员感到担忧，尤其是在决策信任方面。如果申报如当前所做的那样旨在提高透明度，但由于难以定位和解释申报，因此无法实现这一目标。如果仅仅假设透明度可以管理冲突，那么可能会产生意外后果。由于与利益冲突相关的证据，透明度所带来的信任可能是错误的。如果要明确透明度的目的，则需要进一步说明。如果未来的政策重点是减少利益冲突的负面影响，而不是依赖个人找到申报并解释它们，那么政策可能会更成功。
