Communicating cancer risk in the primary care consultation when using a cancer risk assessment tool: Qualitative study with service users and practitioners

Abstract Aim: We aimed to explore service users’ and primary care practitioners’ perspectives on the barriers and facilitators to implementing a cancer risk assessment tool (RAT), QCancer, in general practice consultations. Background: Cancer RATs, including QCancer, are designed to estimate the chances of previously undiagnosed cancer in symptomatic individuals. Little is known about the barriers and facilitators to implementing cancer RATs in primary care consultations. Methods: We used a qualitative design, conducting semi-structured individual interviews and focus groups with a convenience sample of service users and primary care practitioners. Findings: In all, 36 participants (19 service users, 17 practitioners) living in Lincolnshire, were included in the interviews and focus groups. Before asking for their views, participants were introduced to QCancer and shown an example of how it estimated cancer risk. Participants identified barriers to implementing the tool namely: additional consultation time; unnecessary worry; potential for over-referral; practitioner scepticism; need for training on use of the tool; need for evidence of effectiveness; and need to integrate the tool in general practice systems. Participants also identified facilitators to implementing the tool as: supporting decision-making; modifying health behaviours; improving speed of referral; and personalising care. Conclusions: The barriers and facilitators identified should be considered when seeking to implement QCancer in primary care. In addition, further evidence is needed that the use of this tool improves diagnosis rates without an unacceptable increase in harm from unnecessary investigation.

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Are Regulations Safe? Reflections From Developing a Digital Cancer Decision-Support Tool

JCO Clinical Cancer Informatics ◽

10.1200/cci.20.00148 ◽

2021 ◽

pp. 353-363

Author(s):

Ciarán D. McInerney ◽

Beverly C. Scott ◽

Owen A. Johnson

Keyword(s):

Risk Assessment ◽

Primary Care ◽

Patient Safety ◽

Medical Device ◽

Assessment Tool ◽

Risk Assessment Tool ◽

Cancer Risk Assessment ◽

The European Union ◽

Standards And Regulations ◽

Fit For Purpose

PURPOSE Informatics solutions to early diagnosis of cancer in primary care are increasingly prevalent, but it is not clear whether existing and planned standards and regulations sufficiently address patients' safety nor whether these standards are fit for purpose. We use a patient safety perspective to reflect on the development of a computerized cancer risk assessment tool embedded within a UK primary care electronic health record system. METHODS We developed a computerized version of the CAncer Prevention in ExetER studies risk assessment tool, in compliance with the European Union's Medical Device Regulations. The process of building this tool afforded an opportunity to reflect on clinical concerns and whether current regulations for medical devices are fit for purpose. We identified concerns for patient safety and developed nine practical recommendations to mitigate these concerns. RESULTS We noted that medical device regulations (1) were initially created for hardware devices rather than software, (2) offer one-shot approval rather than supporting iterative innovation and learning, (3) are biased toward loss-transfer approaches that attempt to manage the fallout of harm instead of mitigating hazards becoming harmful, and (4) are biased toward known hazards, despite unknown hazards being an expected consequence of health care as a complex adaptive system. Our nine recommendations focus on embedding less-reductionist and stronger system perspectives into regulations and standards. CONCLUSION Our intention is to share our experience to support research-led collaborative development of health informatics solutions in cancer. We argue that regulations in the European Union do not sufficiently address the complexity of healthcare information systems with consequences for patient safety. Future standards and regulations should continue to follow a system-based approach to risk, safety, and accident avoidance.

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