Access to data: A case study of the NHS Bowel Cancer Screening Programme
By Christian Von Wagner
Senior Lecturer at University College London
In a recent blog Chris Carrigan (former director of National Cancer Intelligence Network) highlighted the implications of a loss of access to data for cancer outcomes. In the present blog, I want to follow this up by discussing the impact of recent changes to data access on running trials in the NHS Bowel Cancer Screening Programme.
Since its inception, the NHS Bowel Cancer Screening Programme has always been very pro-active in facilitating research, including a series of behavioural studies aimed at improving information materials to reduce socioeconomic inequalities in uptake. Typically, this has involved evaluating changes to letters or the addition of supplementary leaflets as part of randomized trials.
In England, patients are able to request that their personal confidential information is not shared for purposes other than their own direct care. This is known as a ‘Type 2 objection’. Following the Health and Social Care Information Centre (Patient Objections) Directive 2015, NHS Digital (the national provider of health-related information, data and IT systems) was directed to establish and operate a system to process and uphold Type 2 patient objections. This means that approved research proposals which require patient level data now need to have these datasets cleansed of Type 2 objectors before the datasets are passed onto the researchers.
Due to the complexity of appropriately removing Type 2 objectors from datasets and assuring that the Type 2 objectors anonymity is maintained, there are now additional administrative and financial burdens placed on approved research projects.This means that what used to be a very simple and feasible way of evaluating potential enhancements to the programme has become a lot more complex and expensive, if not downright impossible.
Does it matter?
People might rightly point out that NHS Screening Programmes already provide an excellent service. However, there remain important challenges such as the low uptake of Bowel Cancer Screening and the persistent variation in uptake by socioeconomic and ethnic background. While screening should benefit everyone, uptake varies from 35% in the most deprived quintile of areas to 61% in the least deprived quintile of areas in England (von Wagner et al, 2011). Developing information materials that are carefully designed to reflect information preferences and needs by different groups are essential to avoid widening inequalities in cancer outcomes.
Recently, four very large and nationwide trials attempted just this by modifying the invitation and reminder letter and by adding supplementary leaflets (Wardle, von Wagner et al., 2015). Each of these trials were informed by evidence and theory but it was the outcome of the trials that ultimately demonstrated which of these strategies would have the biggest potential to reduce socioeconomic inequalities in uptake. Being able to evaluate these strategies with everyone invited was crucial and meant that the successful interventions were put forward for implementation straight away.
What can be done?
In the short-term, researchers and clinicians who want to interrogate the NHS Bowel Cancer Screening database for programme approved purposes, are reliant on the good-will and ingenuity of the people running the programme to ‘go the extra mile’ in coming up with appropriate and legal solutions and bear the additional administrative burden (by personal experience I can attest that both good-will and ingenuity are abundant).
However, in the longer-term, these quick-fixes (e.g., sending materials under separate cover) will throw up their own issues, such as the inability to extrapolate findings to the entire screening population, not to mention the potential proliferation of ‘additional’ letters. The interpretation of the directive and its implication for the NHS Bowel Cancer Screening Programme therefore needs to be reviewed. Solutions must be found to be able to carry out basic research in the programme.
Part of this would involve more public engagement on what people regard as the appropriate use of their data within the National Health Services which brings us back to the importance of the ‘use my data movement’ (http://www.usemydata.org/) with a strong emphasis on involving the general public as well as cancer patients.
Another part is for Public Health England to reflect how to support the research and clinical community by facilitating a discussion about whether there are activities (e.g. internal data audits, health promotion activities, or research) which should be exempt from these objections. At the very least it should involve redoubling efforts to streamline approval processes and considering the financial costs imposed on clinicians and researchers.
von Wagner C, et al. (2011). Inequalities in participation in an organized national colorectal cancer screening programme: results from the first 2.6 million invitations in England. Int J Epidemiol, 40, 712–8.
Wardle J, von Wagner C, et al. (2015). Effects of evidence-based strategies to reduce the socioeconomic gradient of uptake in the English NHS Bowel Cancer Screening Programme (ASCEND): four cluster-randomised controlled trials. Lancet, 387, 751-759. doi:http://dx.doi.org/10.1016/S0140-6736(15)01154-X