Investigating the Routes to Diagnosis in Head and Neck Cancer in England: population-based analysis of secondary data ( ODR1718_151/A1 )

Please note this was a previous application under ODR (ODR1718_151) the information below pertains to the original application.

Project Aim and Objectives

To gain a greater understanding of the routes to diagnosis in patients with head and neck cancer.

Objectives:

1. To quantify the percentage of patients within head and neck cancer who present through each of the 8 possible “routes to diagnosis”;

2. To determine whether the percentage of patients presenting through each route has changed over time;

3. To compare the socio-demographic and clinical characteristics of those patients presenting through different routes (with a particular focus on comparing routes to diagnosis in potentially HPV-related and non-HPV related cancers);

4. To conduct a more detailed analysis of different healthcare professionals seen (with a particular interest in identifying who may patients present via dentists);

5. To compare stage at diagnosis for patients diagnosed through different routes;

6. To investigate whether there is any relationship between the route to diagnosis and survival, when other prognostic factors have been accounted for.

The lawful basis for processing personal data in this data request is covered under Article 6(1)e: processing necessary for the performance of a task carried out in the public interest or in the exercise of official authority in the controller.

The legal basis for processing special category data in this data request is covered under Article 9(2)j: processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The data held by NHS England enables assessment of Routes to Diagnosis in Head and Neck Cancers which was the aim of this data application.

This was a standalone project and this is a request to extend the time Newcastle University have the data to allow further analysis.

The primary focus of the project is exploring the routes to diagnosis in patients with a head and neck cancer diagnosis and Newcastle University report below outcomes to date in relation to this. Areas that will be investigated in the extension will be considering the routes to diagnosis for specific cancers and associations between diagnostic route and survival outcomes; these are therefore the topics Newcastle University expect future outputs will focus on.

This project is funded by Population Health Sciences Institute within Newcastle University as part of a student's PhD.

The base cohort will comprise all individuals in the National Cancer Registration database with a malignant (i.e. behaviour code /3) head and neck cancer ICD-10 codes (C01-C14, C32, grouped as follows: hypopharynx (C12, C13), larynx (C32), nasopharynx (C11), oral cavity (C02, C03, C04, C06), oropharynx (C01, C09, C10), palate (C05), salivary glands (C07, C08), other sites (C05, C07, C08, C11, C12, C13), and non-specific sites(C14, C31), diagnosed between 2006-2014. In the event that an individual has two primary head and neck cancers diagnosed in the relevant time period, only the first will be included in the dataset.

The level of data will be; pseudo anonymised - necessary to undertake analysis of population based data in this cohort.

Newcastle University already have data for years 2006-2014 and are not requesting any new data, rather Newcastle University are requesting a 2 year extension to allow time for further analysis as described above and to allow for publications and to allow for additional analysis which may be required after PhD examination.

Geographical spread reflects the diagnosis patterns across England, there are no alternative, less intrusive ways of achieving population based analysis of head and neck cancer routes to diagnosis at a population level.

Efforts have been taken to minimise the data required, we restricted the original request to only those ICD10 codes of interest.

Newcastle University is the only organisation involved, it is the data controller and data processor for the project.

The PhD funder had no role in the data application and analysis. There are no commissioners involved in the application.

Pulsant is where the Newcastle University servers are co-located. This means that the university rents secure rack space at this location where the university hosts its servers. Pulsant only provides a secure managed location and does not have access to any hardware.

The data in this application has already been received and at the time of the original application Newcastle University were not required to supply data flow or a data flow diagram.

The second data flow (2 - on data flow diagram) was from Public Health England to Newcastle University. This transfer of data referred to pseudo anonymised head and neck routes to diagnosis information.

The lawful basis of this flow was GDPR Article 6 1(E) and Article 9 2 (J).

Newcastle University then processed the data for analysis. Data linkage was completed by PHE, no data linkage was undertaken by Newcastle University. Public Health England took steps to mitigate the risk of reidentification should be set out for each stage/linkage.

There was no matching to publicly available data.

There was no attempt to re-identify individuals.

The Data will be accessed onsite at the premises of Newcastle University only.

Data processing is undertaken by a PhD student at Newcastle University under the direction of a substantive employee of Newcastle University, this was acceptable at the time of the initial application. Both the PhD student and substantive employee are trained in GDPR and have completed annual updates of GDPR training.

Data is stored on a secure university network only accessible to the PhD student and the substantive employee of Newcastle University. Policies and procedures are in place in the unlikely event that there is accidental loss, destruction or damage to data.

Only analysed data will be available in publications which may be transparent to the public, this has small number suppression and does not allow identification of individuals. Newcastle University will not share the received data with any other organisation.

The level of data in outputs will be aggregate data with small number suppression that will not allow reidentification of individuals.

The anticipated outputs from this extension request are (i) further publications in peer-reviewed scientific journals and (ii) dissemination of results via conference presentations and associated abstracts. Outputs will cover topics relating to the routes to diagnosis for specific head and neck cancers, for example larynx patients.

The primary focus of the project is exploring the routes to diagnosis in patients with a head and neck cancer diagnosis and we report below outcomes to date in relation to this. Areas that will be investigated in the extension will be considering the routes to diagnosis for specific cancers and associations between diagnostic route and survival outcomes; these are therefore the topics we expect future outputs will focus on.

As this data request is for a project extension, there have already been a number of outputs from the initial data request. These are as follows:

Conference presentations:

Deane, J., Patterson, J., & Sharp, L. (2019) Socio-demographic variation in routes to diagnosis in Head and Neck Cancer: A population based analysis. Orally presented poster at NCRI Conference, Glasgow, UK

Deane, J., Patterson, J., & Sharp, L. (2020) Understanding who presents where: A population-based analysis of the socio-demographic variation in patients presenting as an emergency or urgent cancer referral. Poster presentation at British Association of Head and Neck Oncologists (BAHNO) annual conference, London, UK

Deane, J., Patterson, J., & Sharp, L. (April, 2023). Inequalities in the pathway to a diagnosis of head and neck cancer. Invited speaker at the Barts Centre for Squamous Cancer annual symposium 2023.

Peer-reviewed scientific publications:

Deane, J., Norris, R., O’Hara, J., Patterson, J. and Sharp, L., 2022. Who Presents Where? A Population-Based Analysis of Socio-Demographic Inequalities in Head and Neck Cancer Patients’ Referral Routes. International Journal of Environmental Research and Public Health, 19(24), p.16723.

Other:

Deane, J. Patterson, J., & Sharp, L., (May, 2023). Understanding the role of dentists within the route to diagnosis in Head and Neck Cancer. Invited speaker at the Newcastle University Dental Sciences Summer Seminar Series.

The data obtained in the initial request was used as part of a student’s PhD. The thesis is due to be submitted within the next few months.

It is also anticipated that there will be dissemination of the project’s outputs to a wider, lay audience. This is likely to take on the format of leaflets, podcasts and presentations. It is intended to disseminate the outputs to as wide an audience as possible (researchers, clinicians, patients and the public). Publication in open access journals is preferred in order to enable outputs to be free to users to access and there is funding available for publication by such means through the student’s PhD funding. The timescale of this includes completion of thesis within the next 3 months, publications will follow and be completed by 2025 (Target Journals; BMJ and target conferences: NCRI), and dissemination to lay audiences will be conducted within the next 12 months.

Data ownership belongs with NHS England (PHE) and data management is the responsibility of Newcastle University.

The initial ODR1718_151/A1 (now - ODR1718_151/A2) application was written prior to the “expected measurable benefits statement” question. This update therefore is an amendment of the implications section for the accompanying Protocol from the initial data request.

The primary impact of this project is expansion of knowledge regarding routes to diagnosis in cancer, and in particular the routes of those cancers under the umbrella term of “Head and Neck” cancers. This route has not been examined previously; in particular, evidence is lacking on whether there are socio-demographic inequalities in diagnostic routes. The main individuals considered to benefit from this work are members of the general public experiencing symptoms of a potential head and neck cancer. The project seeks primarily to understand the routes that patients take to a diagnosis of head and neck cancer and understand if there are any patterns in usage, or identify if there are any inequalities inherent within these routes. We intend that the findings will raise awareness of patterns and inequalities among health professionals involved in care of patients with suspected, or confirmed, head and neck cancer and of health service decision makers, benefiting them in the short-term. In the longer-term and ultimately, understanding if and where inequalities occur provides powerful evidence to support the development of strategies to improve equity, thus benefiting those patients who may have been more at risk of delay within their journey to diagnosis.

The secondary impact is promotion of further understanding of head and neck cancer. There has been an increase in incidence of head and neck cancers over recent years and it is important that there is understanding of the whole pathway so areas of further research and understanding are identified. This is thus a benefit to the research and clinical communities with an interest in head and neck cancer and, ultimately, to patients at risk of this condition.

The third impact and benefit relates to public health. Specifically, there is considerable concern about the adverse impacts of the health service disruption that resulted from the covid-19 pandemic on cancer diagnosis and outcomes. This data, and the previous and planned analyses, provides a pre-covid “baseline” against which any impacts on diagnostic routes in head and neck cancer may be assessed. This, in turn, will inform the need for remedial public health interventions and/or strategies to be put in place to prevent similar impacts in the event of future health service disruption.

Finally, with respect to the health and social care sector, cancer has a significantly detrimental impact on national economics and society as a whole, so studies (such as this one), which have the potential to lead a reduction in inequalities in cancer diagnosis can benefit the economy and society. Cancer diagnosed at a late stage and, for example, through emergency presentation, can often require more toxic and aggressive treatments, impacting a patient’s ability to work and increasing co-morbid conditions and the likelihood of earlier death. Cancer organisations, researchers, the NHS and governments all have an invested role in prioritising inequality reduction as a matter of social justice. The wider public will benefit from the expansion of knowledge regarding the scale of health inequalities in cancer care in England. Understanding these inequalities is the first step in starting to address them. Furthermore, the results will be important for ensuring that future policies and interventions do not exacerbate inequalities further.

The project’s outputs will achieve the stated purposes and thus the benefits of processing by:

i. Describing the routes used by head and neck cancer patients (as a group, and for specific sub-sites within the head and neck) to obtain a diagnosis of a cancer.

ii. Inequalities in different routes (Emergency, Primary Care or Urgent Cancer Referral (2WW)) will be explored by investigating variations in routes taken according to patients’ age, sex, ethnicity and socio-economic status .

iii. Exploring the primary care route further by considering referrals by dentists and general practitioners separately.

iv. Describing, where possible, the survival outcomes associated with being diagnosed with head and neck cancer through specific routes.

Dissemination of the results of this work (peer-reviewed publications, conference presentations, lay summaries) are particularly beneficial for raising the issues of inequalities in the pathway to wider clinical, academic and lay audiences. It is hoped that doing so will promote action for change.

The actions leading up to the benefit will be carried out in the first instance by the data controller. It is anticipated that the benefits will be measured by project outputs (e.g. publications) and longer term by further research into why these diagnosis inequalities exist along with any efforts to minimise their existence in the first instance. Some benefits are expected to be delivered by the extension end date 2025, others will occur beyond this date (given the sometimes, extended timeline for review, revision, and publication of scientific papers)

The benefits yielded to date from the project so far have been as follows. The work has shed light on the scale of health inequalities still present in England despite considerable focus on improving earlier diagnosis of cancer. This is the first step towards starting to address this inequity. The results have highlighted that whilst there have been positive changes over time, for example the increase in cancers picked up through the urgent cancer referral route (2WW) there are significant socio-demographic inequalities. Older age, living in an area of greater deprivation and being from a non-white ethnic group increased the likelihood of being diagnosed through the emergency pathway. This is concerning as emergency cancer presentations may be considered a “failure” of the system and indicative of significant delays or barriers to presentation. This work provides a foundation for further work in this area, by highlighting those who are most vulnerable to further delays and providing clear areas to focus on. Indeed, on the basis of this work, the team have secured research funding to undertake a comprehensive investigation of inequalities across the head and neck cancer pathway, from route to diagnosis, through stage, treatment receipt and survival