The first CanRisk workshop was held in September 2016, and included genetic epidemiologists, clinicians from primary and specialist care and public health, social scientists and members of the research team. The discussions were wide-ranging, and included debates about the purpose of the cancer risk prediction tool and its target population. We discussed whether cancer risk assessments were for the general population, women with concerns, women presenting with symptoms, or for women already diagnosed with breast cancer.  Everyone agreed on the utility of a CanRisk tool, but most felt that each clinical setting will have a different requirement from the tool. Primary care clinicians wanted a quick and easy-to-use tool. Tertiary care clinicians recommended patients being able to pre-complete parts of the tool prior to clinic with the possibility of including additional cancer genes. Both groups strongly felt that the risk factors needed to be easy to update. Secondary care clinicians indicated that the tool could have increased utility among the screening population and in the prediction of contralateral breast cancer risk, rather than in patients presenting with symptoms.  Most agreed that the tool could aid in referral decisions for patients, supporting the clinician, reassuring patients, or used in shared risk management. This validated CanRisk’s aim- to provide accurate risk information while being user-friendly for different clinical settings in supporting effective assessment and appropriate management decisions.

Workshop participants had wide-ranging discussions around the risk factors to include in the CanRisk tool, and agreed that family history will be the most complex data to collect. Discussions about risk factors were focused on definitions, their importance based on available evidence, and their impact on the risk assessment. Considerations of risk thresholds and predictive power contributed to debates about having a step-wise/ triaged/ weighted/ staged system for the model working in different clinical settings. Some participants also discussed the potential additional contributions of weight gain, prior surgery, contralateral breast cancer, cancer subtypes and ethnicity.

Electronic data storage and the transfer of data between patients and the different health care providers were considered to be desirable but challenging, especially with the current IT systems used across healthcare settings. These challenges were felt to relate to issues of confidentiality (both at individual and family level), safekeeping of data, tracking of updated data, and what risk information was communicated when and by whom. Participants mainly agreed that the optimal setting for data storage was as part of a NHS-run system such as N3, and we are exploring this option and related regulatory issues.

There was strong agreement around the desirability for patients collecting and entering relevant information prior to clinical visits, with multiple user access to the data as the patient navigates through the healthcare system.  Risk assessment could then be completed by a healthcare professional, who would also check and complete the risk factor data from medical records when needed. Ideally, the risk assessment would be communicated by a healthcare professional that would discuss and decide with the patient the next steps, based on local and national guidelines and recommendations. There was debate around providing management advice with the outputs and whether it is the responsibility of the clinician or the tool when it is used globally and needs to be updated as regulations and guidelines change between healthcare settings and countries.  Participants agreed that the output should provide a range of approaches to framing risk information (absolute, relative, expected frequency trees etc) to accommodate the needs of the clinician and the patients; they also agreed on the desirability of additional general health advice, and some demonstration of the benefits of possible interventions. It was understood that some assessment on the clinical utility and validity would be done, as well as a harms, risk and benefits analysis. To ensure all regulatory obligations are adhered to we need to determine which regulations the tool would need to comply with.

We are now developing the first version of the tool, defining the layout and the ways we will collect risk factor information, developing aspects of risk communication and risk management, and pursuing how best to integrate the tool within NHS systems. We are also arranging focused meetings with key clinicians and patients for early next year to discuss the prototype cancer risk assessment tool.

Once again we would like to thank everyone who participated in the workshop, and wish all a very happy Christmas and peaceful and productive 2017!