New study highlights flaws in UK’s declaration of interests system for health professionals

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Monday 7 August 2023

A new study published in BMJ Open has identified significant shortcomings in the UK’s “declaration of interests” system for health professionals. Led by NHS Research Scotland Fellow Dr Margaret McCartney and co-authored by Director of Research Professor Frank Sullivan, the study found that under the current scheme, such declarations are prohibitively difficult to both locate and interpret. These barriers undermine the crucial capacity of both laypeople and healthcare professionals to make informed treatment decisions.

In a healthcare context, declarations of interests (DOI) are statements made by professionals to inform patients and stakeholders of any potential conflicts that could influence decision-making and patient care. A conflict of interest (COI) refers to a situation where a healthcare professional’s personal, financial, or professional interests may compromise their primary duty to prioritise patient welfare. DOI help preserve trust in professionals’ recommendations, among both their colleagues and the broader public. Currently, the UK has a voluntary system for disclosing payments from pharmaceutical companies to professionals (Disclosure UK), and NHS England mandates disclosures for staff.

Given the importance of DOI to maintaining trust in the healthcare system, Dr McCartney’s team sought to examine whether the UK’s current DOI process is fit for purpose. Specifically, they investigated whether professionals, citizens, and patients could locate UK health professionals’ DOI and how they perceived and interpreted this information.

The study was conducted in three phases. In the first phase, the team searched online for the DOI of 13 public-facing healthcare professional participants (HPPs). Each declaration was then approved by the corresponding HPP as correct and complete, forming a DOI “gold standard.”

In the second phase, 379 laypeople, other healthcare professionals, and healthcare students read and answered questions about four clinical vignettes featuring doctors with varying levels of financial COI. These conflicts were either not present, present and declared, or present but not declared. The participants were asked about how much they trusted the doctor in each scenario and felt they were acting in the patient’s best interest. 297 of these participants then agreed to complete an additional task: each was randomly assigned to one of the Phase I HPPs and asked to search for and report their DOI.

The third phase consisted of qualitative interviews with 21 of the Phase II lay respondents. These sessions were aimed at gaining a more nuanced understanding of participants’ perceptions of declarations and conflicts. They included questions about what DOI and COI are, how important they are, and how they should be managed.

The Phase II results showed that participants’ trust in doctors decreased steadily with increasing financial COI and was lowest when the COI was present and not disclosed. Results from the Phase III interviews found that 85% of participants identified DOI as “definitely” or “probably” important.

Phase II also revealed that despite all elements of the HPPs’ “gold standard” DOI being publicly available, participants found this information extremely challenging to locate. Only 36% found links to sources designed as formal DOI, while a mere 3% found all of the information contained in their HPP’s “gold standard” declaration.

Phase III interview responses reinforced and expanded on the Phase II results, revealing mixed perspectives on the UK’s DOI system. The challenges of finding DOI were again noted, alongside the difficulty of defining what qualifies as a COI. While some conflicts are clear-cut – such as when a health professional receives direct financial benefit for recommending a certain treatment – others are more nuanced. This poses a challenge for both patients, who may struggle to decide whether professionals’ interests create a serious conflict, and professionals, who may be unclear on what they are required to disclose.

Given these challenges, interviewees also emphasised the need for careful management of potential conflicts. This included improved management of both the system of making, storing, and viewing declarations and the process of addressing any conflicts that arise. Suggested solutions included implementing a mandatory national register of interests, employing more patient advocates, and creating a clear process for excluding conflicted professionals from relevant decision-making.

However, respondents also identified several risks that will need to be considered when revising DOI policies. These included unduly increasing professionals’ workload with new requirements, complicating patients’ decision-making by overloading them with information, and jeopardising the research and education benefits stemming from industry funding.

Discussing the implications of these findings, Dr McCartney said, “We have found that citizens and patients think that DOI are important and want to know about them – but our current systems are not good enough to let that to happen. This is not necessarily because doctors are not trying to be honest. Instead, it’s because we don’t have a good enough system to make, store and view declarations in.”

“We also found that there were many nuances to participants’ views on DOI and it’s not good enough just to declare interests – we have to make sure declarations are made in ways that allow us to understand their meaning. We hope to do further research in this area to work out how best to do this. We are very grateful to everyone who took part in our research and the University of St Andrews and the CSO office for funding.”

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