The Role of Selective Neck Dissection Used Electively in Patients

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + NDRS Cancer Consolidated Data Set

Objective for processing

Saving Faces – The Facial Surgery Research Foundation (Saving Faces) wishes to continue to hold data previously disseminated and request new data for the SEND Trial (selective neck dissection used electively). The SEND Trial is a prospective randomised controlled trial that compares two standard surgical treatments for early oral cancer with no clinical evidence of lymph node metastases in the neck. The fundamental aim and purpose of the study is to find better ways of treating patients with early mouth cancer. Saving Faces – The Facial Surgery Research Foundation requires access to NHS England data for the purpose of the following research programme: This is a stand-alone project that aims to answer a specific clinical question which is to determine whether the use of a selective neck dissection used electively (SEND) on all patients presenting with T1 and T2 tumours (and no clinical evidence of neck metastasis (N0) improves survival, disease-free survival and loco-regional disease (disease restricted to a localised region of the body) control rates. T1, T2, T3, T4 refers to the size and/or extent of the main tumour. The higher the number after the T, the larger the tumour or the more it has grown into nearby tissues. The Role of Selective Neck Dissection Used Electively in Patients. GDPR Article 6(1)(f) is the justification of processing the data for the purposes of legitimate interests. The data controller believes this trial is the only nationwide multicentre pragmatic trial ever conducted regarding any aspect of the surgical management of head and neck and mouth cancer. It aims to answer a research question that people had tried unsuccessfully to solve for the past 40 years. Saving Faces developed and manage this clinical trial and want to find out whether an elective neck dissection (END) improves survival, disease-free survival and loco-regional disease control rates for T1/T2 N0 head and neck cancer patients. The following is a summary of the aims of the research programme provided by or on behalf of Saving Faces – The Facial Surgery Research Foundation: The answer to this research question is designed to benefit patients' and society as a whole, through facilitating better healthcare in the UK. The fundamental aim and purpose of the study is to find better ways of treating patients with early mouth cancer. This includes aiming to answer a specific clinical question which is to determine whether the use of a selective neck dissection used electively (SEND) on all patients presenting with T1 and T2 tumours (and no clinical evidence of neck metastasis (N0) improves survival, disease-free survival and loco-regional disease (disease restricted to a localised region of the body) control rates. T1, T2, T3, T4 refers to the size and/or extent of the main tumour. The higher the number after the T, the larger the tumour or the more it has grown into nearby tissues. To determine the lawfulness of processing the data for these legitimate interests, Saving Faces Ltd. has undertaken a Legitimate Interests Assessment (LIA) and determined that: The following NHS England Data will be accessed: i. The processing is necessary for the purpose: • Civil Registration Mortality – necessary because this is the most accurate source of data. The study team anticipate that a few patients (<5%) will be lost to follow up and there is no other way of determining their survival status. There are no alternative, less intrusive ways of achieving the study purpose. The processing of data is necessary as the study team would not be able to calculate survival, disease-free survival and loco-regional disease control rates for T1/T2 N0 head and neck cancer patients without collecting health and mortality data. The study team will use the minimum amount of personally-identifiable information possible. The study team could not achieve the same purpose without the processing of this data. • NDRS Cancer Consolidated Data Set (package 9 & 11) – necessary because the trial was designed where overall survival was the only major endpoint of interest; typical for the type of cancer trial like SEND. However, since then and for many cancer types, disease-free survival (where any cancer occurrence or death is an event) is a major and often primary endpoint too. The SEND trial also have cancer-specific mortality (ie death from oral cancer only is the event). All 3 of these outcomes were published in the first main paper, so SEND are obliged to do the same for the 10 year follow up paper planned in 2025/26. Mortality data from NHS Digital is the most accurate source of data for this purpose. The study team anticipate that a few patients (<5%) will be lost to follow up and there is no other way of determining their survival status. There are no alternative, less intrusive ways of achieving the study purpose. • Patient Demographics - so that Saving Faces can ensure the correct information is linked to the correct patient. If the data provided by NHS England differs to the data held by Saving Faces, the study records are updated to replace incorrect records with the latest data from NHS England. ii. The interests of the individual data subjects do not override the legitimate interest: The level of the Data will be: Data is collected directly from the individual or from health records. The study team remind the patients of this when they are asked to complete questionnaires. The data requested under this Agreement from NHS Digital was made clear at the time of consent and is mentioned in the consent form. The data has been collected since 2007 to now. The intended purpose and method is widely understood and patients have the opportunity to ask questions at all stages throughout the study. The study do not use any new or untried methods. When the study was being developed, the study team sought patient and public involvement so there has been input and consultation from external sources. The expectations are acceptable to participants of the study. • Identifiable – necessary because for the purpose of mortality flagging. Saving Faces receive patient consent forms by post where necessary and also maintain patient identification logs in both paper form and on an encrypted storage device. iii. The processing is proportionate to the purpose: The Data will be minimised as follows: The mission of Saving Faces is to educate, fund and lead research into reducing the incidence of facial injuries, disorders and diseases including oral cancer. The study team will use the data collected from patients who have consented to participate in this study to follow up their health status. No third parties benefit from the processing. The wider public benefits are the potential to improve survival, disease-free survival and loco-regional disease control rates for head and neck cancer patients worldwide. • Limited to a study cohort identified by Saving Faces – The Facial Surgery Research Foundation – the cohort will consist of 609 patients who have consented. These benefits are hugely important as 369,000 patients are diagnosed with OSCC (oral squamous cell carcinoma) worldwide each year. If the study team could not access the data requested under this Agreement, then there would be no way to answer this important research question that people have tried unsuccessfully to solve for the past 40 years. The data is not used for any automated decision-making, including profiling. The study team comply with guidelines from: Saving Faces – The Facial Surgery Research Foundation is the research sponsor and the data controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above. · Health Research Authority · Research Ethics Committee The lawful basis for processing personal data under the UK GDPR is: · R&D (Joint Research Management Office (JRMO) for Barts Health NHS Trust and Queen Mary University of London) Article 6(1)(f) - processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party. · General Data Protection Regulation (GDPR) · Data Protection Act 2018 (DPA 2018) · Good Clinical Practice (GCP) “Saving Faces – The Facial Surgery Research Foundation has determined the processing is necessary for its legitimate interests in being able to provide tools and services that will benefit healthcare organisations.” · UK Policy Framework for Health and Social Care Research The data controller believes this trial is the only nationwide multicentre pragmatic trial ever conducted regarding any aspect of the surgical management of head and neck and mouth cancer. It aims to answer a research question that people had tried unsuccessfully to solve for the past 40 years. Saving Faces developed and manage this clinical trial and want to find out whether an elective neck dissection (END) improves survival, disease-free survival and loco-regional disease control rates for T1/T2 N0 head and neck cancer patients. The data controller engaged public and patient involvement (PPI) relating to SEND and other head and neck cancer projects during the setting up of the study. Since recruitment closed, the findings of the study have been disseminated via newsletters to the participants and also published on the study website. The data controller's website is regularly updated with news regarding the SEND study. The findings will enable surgeons for the first time to provide clear evidence regarding the benefits and impact of elective neck dissection for their patients thereby enabling patients to participate more effectively with decision-making regarding their treatment. The lawful basis for processing special category data under the UK GDPR is: In addition, the data controller is processing under GDPR Article 9(2)(j). This clinical trial is of public interest as it has the potential to improve survival, disease-free survival and loco-regional disease control rates for head and neck cancer patients. The findings will enable surgeons for the first time to provide clear evidence regarding the benefits and impact of END for their patients thereby enabling patients to participate more effectively with decision-making regarding their treatment. 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 trial has been closed to new patient recruitment since 2015 but due to the findings published in 2019 showing, that patients with early mouth cancer who have resection of the cancer in the mouth and elective neck dissection (END) at the same time have a survival benefit of 30% compared to patients who only have resection of the mouth cancer leaving the neck glands untouched, there is reason to follow up patients for 10 years due to the risk of the cohort of patients getting new tumours. Saving Faces can then compare results of studies on the tissue that Saving Faces hold from these patients to identify tissue markers that differ between those that develop new tumours with those that don’t. Results of the studies in the future may deliver biopsy or blood results that risk ratify for those patients that need radical surgery and radiotherapy and those that don’t. This clinical trial is of public interest as it has the potential to improve survival, disease-free survival and loco-regional disease control rates for head and neck cancer patients. The findings will enable surgeons for the first time to provide clear evidence regarding the benefits and impact of END for their patients thereby enabling patients to participate more effectively with decision-making regarding their treatment. The cohort consists of patients diagnosed with T1/T2 N0 OSCC (oral squamous cell carcinoma) who have consented to be randomised to resection of the tumour only or resection with neck dissection. An additional cohort of T1/T2 N0 patients who did not wish to enter the randomised trial or who were not considered to be clinically suitable for randomisation have consented to be followed up. The funding is provided by Saving Faces – The Facial Surgery Research Foundation. The funding is specifically for the trial described. Funding is in place until 2026. The main aims and purpose of the study are: The funder(s) will have no ability to suppress or otherwise limit the publication of findings. 1. To determine whether the use of a selective neck dissection used electively (SEND) on all patients presenting with T1 and T2 tumours and no clinical evidence of neck metastasis (N0) improves survival, disease-free survival and loco-regional disease control rates. University College London (UCL) is a processor (acting under the instructions of Saving Faces – The Facial Surgery Research Foundation). University College London’s role is limited to the trial statistician who is a substantive employee of UCL and are allowed to carry out data processing. 2. To determine how SEND and complex reconstruction affect quality of life (QoL) and mental health. Amazon Web Services (AWS) is a processor acting under the instructions of UCL. AWS’ role is limited to secure back-up of data stored in UCL. 3. To determine whether the use of SEND on all patients presenting with T1 and T2 tumours and clinically N0 necks represents a cost-effective use of resources. When the study was being developed, the study team sought Public and Patient Involvement and Engagement group to provide input and consultation from external sources. The expectations are acceptable to participants of the study. The main results of the trial were published in 2019. The patient representatives, who represented Saving Faces, would have been disbanded since then (indeed some would have died), as is usual for trials. They do not continue their roles for long term follow up analyses. The main aims have been analysed and reported on but there are several subsidiary aims that still need work. Details of these subsidiary aims that are ongoing are: 1. Disease-free survival 2. Local and regional recurrence 3. Completeness of resection at the primary site. 4. Patients’ Quality of Life (EORTC QLQ-30 & H&N module) at 6, 12 and 24 months from treatment. 5. Costs to NHS, patients and carers/families. Incremental cost per life year saved and/or per quality adjusted life year (QALY). The original study requested data for four years from the date of consent in 2011 until 2015. In October 2015 the data controller requested an extension of the study from 30th April 2015 to 31st July 2020, to allow for 5 year follow up of consented patients at all sites. More recently Saving Faces has obtained ethical approval for a further 5 years follow-up (ten years altogether) until July 2025. Under this Agreement, Saving Faces require access to date and cause of death in relation to the cohort. The date and cause of death are used to calculate overall survival for the patients and find out the cause of death to determine whether the death was related to their cancer or their treatment for the cancer. The data are also used to determine the efficacy and safety of the treatments and to identify and quantify risk and protective factors. Saving Faces request identifiable data so that data can be linked to the correct patient and determine risk factors from their medical history. Patients were recruited from 27 hospitals across the UK as the study aimed to recruit a sample that is, as far as possible, representative of all UK head and neck cancer treatment centres and patients. The results are therefore readily generalisable across multiple UK hospitals in a routine surgical cancer setting, including those who treat smaller patient numbers. Mortality data from NHS Digital is the most accurate source of data for this purpose. The data controller anticipates that they will have lost contact with a few patients (<5%), and there is no other way of determining their survival status. There are no alternative, less intrusive ways of achieving the study purpose. The data fields requested under this Agreement have been reviewed by the data controller in line with data minimisation guidance. Under this Agreement the sole Data Controller is Saving Faces and the Data Processors are Saving Faces and University College London (UCL). Under previous iterations of this Agreement UCL were not included as a data processor, but moving forward there will be a trial statistician involved in the study who is a substantive employee of UCL and not employed by the data controller. For clarity the department with UCL where the trial statistician is employed is called 'The Cancer Research UK & UCL Cancer Trials Centre', this is based at and run by UCL, not Cancer research UK. There is a Data Processing Agreement in place between Saving Faces and the study’s trial statistician who is based at UCL. The statistician is not responsible for making any decisions pertaining to the collation or processing of data under this Agreement and UCL are therefore not determined to be a data controller under this Agreement. The SEND Trial has previously been funded by Cancer Research UK (CRUK) and other donors. However, current funding is provided internally by the data controller, Saving Faces. CRUK are not, nor have ever been listed as a data controller under this Agreement, as they are not responsible for any decision making regarding the data under this Agreement. The Joint Research Medical Office (JRMO) for Queen Mary University London (QMUL and St Bart's Health, are sponsor for the trial and are listed in various supporting documentation. The data controller has confirmed that the study sponsor act in an advisory manner and review documentation such as ethics and protocols before they are submitted to the relevant authorities. They do not however make any decisions regarding how the study is run, what data is collected and how the data is processed. They are therefore not acting as a data controller for the data under this Agreement.

Processing activities

• As part of this study, Saving Faces and participating sites in the study collected identifiable patient data on paper Case Report Forms which is then submitted to Saving Faces, the Trial Centre, via post. Saving Faces – The Facial Surgery Research Foundation will transfer data to NHS England. The data will consist of identifying details (specifically Forename, Surname, Date of Birth Study ID and NHS Number for the cohort to be linked with NHS England data. • Saving Faces processes the data at every stage – the identifiable data is in the form of patient consent forms and patient identification logs that are kept in paper form and on an encrypted storage device. These are stored securely in locked cabinets or a fireproof safe of which only the Trial Coordinator and Chief Investigator have access to. NHS England will provide the relevant records from the NDRS Cancer Consolidated Data Set and Civil Registrations of Death datasets to Saving Faces – The Facial Surgery Research Foundation. The data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient. • For this Data Sharing Agreement, Saving Faces will provide NHS Digital with identifying demographics: forename, surname, date of birth and NHS number of patients to be flagged. Saving Faces – The Facial Surgery Research Foundation will extract a subset of the Data containing/comprised of pseudonymised data consisting of patient ID, site code and initials and securely transfer this to UCL Cancer Trials Centre Cancer Institute within University College London (UCL). • NHS Digital provides health data – date and cause of death as well as the personal identifiable data: forename, surname, date of birth and NHS number so that Saving Faces can ensure the correct information is linked to the correct patient. If the data provided by NHS Digital differs to the data held by Saving Faces, the study records are updated to replace incorrect records with the latest data from NHS Digital. The Data will be stored on an encrypted storage device at Saving Faces – The Facial Surgery Research Foundation and on servers at University College London. • Saving Faces then pseudonymises the identifiable data from NHS Digital by using the assigned patient ID, site code and initials and enters that on to paper case report forms and into an electronic trial database. Saving Faces – The Facial Surgery Research Foundation uses encrypted storage devices as back-up which are locked in a fireproof safe. All Cancer Trials Centre electronic trial data at UCL is backed up each night using Veeam Backup and Replication software. The local backup is off loaded to the UCL provided off-site Amazon Web Services (AWS) cloud solution. AWS is not permitted to access the data. • Saving Faces requires identifiable data (forename, surname, date of birth, NHS number) for the purpose of mortality flagging. Saving Faces receive patient consent forms by post where necessary and also maintain patient identification logs in both paper form and on an encrypted storage device. Saving Faces also receives pseudonymised data in the form of completed paper case report forms from participating sites and this data is entered into the trial database. The Data will be accessed onsite at the premises Saving Faces – The Facial Surgery Research Foundation and on site at University College London only. • A copy of the pseudonymised data is then shared with The Cancer Research UK & UCL Cancer Trials Centre Cancer Institute within University College London (UCL). Electronic pseudonymised data is extracted from the trial database by the Trial Co-ordinator in accordance with the Data Sharing Agreement. The UCL trial statistician receives an electronic copy of the entire pseudonymised trial database to perform the statistical analysis required. The trial statistician returns outputs which are of aggregate data and not on an individual patient level. The pseudonymised data is transferred to UCL securely by extracting the data and storing it on an encrypted USB storage device and transported to the trial statistician at UCL who is responsible for the statistical analysis by means of courier. The Data will not leave England/Wales at any time. The mortality data is checked carefully to ensure that it relates to the correct patient and is then added to the pseudonymised data in the trial database (diagnosis, treatment, follow up etc), which is kept on a stand alone laptop that is not connected to the internet. The combined data in the trial database are transferred to the trial statistician on a storage device and then analysed to ensure the correct calculation of disease free and overall survival for the patient and to determine risk and protective factors. Access is restricted to individuals within the SEND Trial Team of Saving Faces – The Facial Surgery Research Foundation who have authorisation from the Chief Investigator. All such individuals are substantive employees of Saving Faces – The Facial Surgery Research Foundation or University College London. The data is only linked to data that Saving Faces has collected within the scope of the SEND Trial with the patient’s consent. The trial collects: patient demographics, cancer diagnosis, cancer treatment, follow up data including any recurrences or new primaries and any treatment outcome such as death or lost to follow up. Saving Faces will not link the data with any data other than mortality data obtained from NHS Digital. There is no requirement to re-identify patients. All personnel accessing the Data have been appropriately trained in data protection and confidentiality. Only authorised members of the SEND Trial study team who are substantive employees of Saving Faces, and the trial statistician who is a substantive employee of UCL, are allowed to carry out data processing and they are trained in Good Clinical Practice and Information Security. Only the Chief Investigator, Trial Co-ordinator and the Clinical Research Manager, and the UCL trial statistician can access the data. The data consists of: The Data will be linked at person record level with datasets obtained from participants who consented to the SEND Trial. • Patient consent forms and patient identification logs that are kept in paper form and on an encrypted storage device The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset. • Paper-based records of SEND and other consented trial participants and patients who have been screened for eligibility including pseudonymised case report forms and pseudonymised pathology and other medical reports relating to the study treatment. The study team will only analyse the Data for the purposes described above. • The SEND trial database is written in Microsoft Access 2004. It is password protected within an encrypted external hard drive and used on a stand-alone laptop without any connection to an outside network. • Backup copies will be protected on encrypted storage devices in a locked fireproof safe. • Data will be extracted from the SEND eCRF database and stored on an encrypted storage device and transported to the trial statistician by means of courier. This data is extremely valuable and has already been used for one highly cited paper in the top 5% of all scientific papers that have ever been published. The data is expected to change clinical practice and will be used by Saving Faces for many more papers. It is possible that other organisations may wish to study the data and however they will be instructed to apply to Saving Faces and in addition make a separate application to NHS Digital in order to use the data. In any case, the data under this Agreement will not be shared with any other organisation unless a successful Data Sharing Agreement with NHS Digital is in place.

Expected output

As a result of the data processing, Saving Faces will produce a number of papers that, subject to acceptance, will be published in peer-reviewed academic or clinical journal. An initial open-access paper was published in the British Journal of Cancer in October 2019. As well as reporting the SEND prospective randomised trial and a parallel prospective study of patients who refused randomisation, the paper included a meta-analysis of the 5 previous trials and the SEND study to produce a complete evidence base. Saving Faces will continue to present results at international and public conferences. The expected outputs of the processing will be: The results of the final analysis will be published at the end of the study, which is anticipated to be in 2025. The results will also be disseminated and presented at relevant conferences, for example at the British Association of Oral and Maxillofacial Surgeons’ Annual Scientific Meeting. Saving Faces findings will also be publicised on relevant media such as the Saving Faces’ website and social media channels. The Saving Faces' Chief Executive is invited to attend and speak at many events and also give interviews to the press, including newspapers, radio and TV and will speak of this research at relevant opportunities. Other papers relating to patient demographics, pathology, mortality, health economics and quality of life are also planned between now and the end of the study. • A report of findings to be published at the end of the study, which is anticipated to be in 2025/2026. The data processing outputs will also inform the reports that are required under Saving Faces’ clinical trial obligations, such as regular reports to funders, the Health Research Authority, Ethics committee, and sponsor. • Submissions to peer reviewed academic or clinical journals. All outputs will contain only data that are aggregated, with small number suppression. • Presentations at relevant conferences, for example at the British Association of Oral and Maxillofacial Surgeons’ Annual Scientific Meeting. The dissemination activities will target an audience of researchers, scientists, innovative technology-focused organisations, research participants. Activities should also reach beyond the scientific community to engage with policy makers. The aim of the dissemination activities shall be two-fold: to enable the engagement with the scientific and policy-making communities / to ensure that knowledge developed by the research can benefit these communities. • Publication of findings will be made available on the Saving Faces – The Facial Surgery Research Foundation website and media channels. These outputs will only ever involve the use of aggregated data with small numbers suppressed. The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived. The results from the SEND Trial will be published in medical and scientific journals, disseminated on the Saving Faces website and newsletters, other websites including Cancer Research UK (CRUK), the British Association of Oral and Maxillofacial Surgeons (BAOMS) and the British Association of Head & Neck Oncologists (BAHNO). Saving Faces will publicise and promote the research on social media, conferences, talks, presentations and send out a press release to the media such as newspapers, radio and TV. The outputs will be communicated to relevant recipients through the following dissemination channels: Many outputs have already been produced from the data obtained under this Agreement. Further outputs from the study will consist of research publications, in open-access format wherever possible, which are intended to inform clinical and patient decision-making. Conference presentations and social media will also be used to disseminate the results. • Journals. The process of reviewing national guidelines has already begun with input from third parties – a paper written by the European Association of Cranio Maxillofacial Surgery (EACMFS) Head & Neck Oncology Group recommending the use of elective neck dissection for all T1/T2 N0 head and neck cancer patients has been submitted for publication and this will confirm the guidelines in Europe. Another paper has been submitted to the Journal of the National Comprehensive Cancer Network (JNCCN) in the US which also supports Saving Faces’ findings and this may lead to National Comprehensive Cancer Network (NCCN) guidelines being changed. • Published on websites such as Saving Faces – The Facial Surgery Research Foundation, Cancer Research UK (CRUK), the British Association of Oral and Maxillofacial Surgeons (BAOMS) and the British Association of Head & Neck Oncologists (BAHNO). • The Cancer Research UK website. A report of findings is expected at the end of the study in 2025/ early 2026.

Expected measurable benefits

Sharing The findings of this data will hopefully research study are expected to contribute to evidence-based decision-making to allow clinicians and patients to make better informed choices based on high quality Level 1 evidence regarding their treatment [18 words unchanged] least one properly designed randomised controlled trial, which the SEND Trial is. Saving Faces also conducted a meta-analysis of the 5 previous T1/T2 N0 trials and the SEND study to produce a complete evidence base. The study has the potential to change clinical practice and national guidelines worldwide. These guidelines may include the UK’s National Institute for Health and Care Excellence (NICE) guidelines and the US National Comprehensive Cancer Network (NCCN) guidelines. The British Journal of Cancer paper included for the very first time evidence on adverse events, resource use and quality of life outcomes enabling patients to make informed choices about the treatment that was offered balancing the survival benefit of END against any adverse events and Quality of Life (QoL) outcomes. The use of the data could: The outputs will hopefully provide evidence to inform treatment choice for T1/T2 N0 head and neck cancer patients as the study has shown that an elective neck dissection will improve overall survival and disease free survival. • Potentially change clinical practice and national guidelines worldwide, which may include the UK’s National Institute for Health and Care Excellence (NICE) guidelines and the US National Comprehensive Cancer Network (NCCN) guidelines. The legitimate interest is fulfilled as the research question of whether an elective neck dissection improves overall survival, disease-free survival and loco-regional disease control rates • Provide evidence to inform treatment choice for T1/T2 N0 head and neck cancer patients is answered, as the study has shown that an elective neck dissection will improve overall survival and therefore can help inform treatment choice, and may have the potential of changing national guidelines and clinical practice worldwide. All patients signed a detailed consent form based on a comprehensive information sheet. disease-free survival. It is expected that 21,000 patients lives could be saved worldwide each year. This is a conservative estimate based on 369,000 patients diagnosed with OSCC (oral squamous cell carcinoma) worldwide each year (reported in Saving Faces’ open-access paper https://rdcu.be/bVfLH). Approximately 30% (information from Public Health England cancer registries) of new head and neck cancer diagnoses will likely be T1/T2 N0 patients which is around 110,700 patients. A third of these, 36,900, will likely benefit from having a neck dissection. Some surgeons may still not offer the neck dissection treatment while it is not part of the national guidelines, and some patients may not opt for the more aggressive treatment even if it is offered, hence Saving Faces publicised the figure of 21,000 patients worldwide each year. • Evidence on adverse events, resource use and quality of life outcomes enabling patients to make informed choices about the treatment that was offered balancing the survival benefit of END against any adverse events and Quality of Life (QoL) outcomes. These actions will be carried out by Saving Faces, Cancer Research UK (CRUK), the British Association of Oral and Maxillofacial Surgeons (BAOMS) and the British Association of Head & Neck Oncologists (BAHNO) in collaboration with head and neck cancer patient groups. These groups are likely to be local groups within hospital settings that Saving Faces can ask for input rather than dissemination. • Expect 21,000 patients’ lives could be saved worldwide each year. Other third parties may also contribute to having the national guidelines reviewed. These include members of the head and neck surgeon community and clinicians. The specific benefits to patients are expected to provide evidence as to whether an elective neck dissection improves overall survival, disease-free survival and loco-regional disease control rates for T1/T2 N0 head and neck cancer patients is answered, and therefore can help inform treatment choice, and may have the potential of changing national guidelines and clinical practice worldwide. Saving Faces expect that these benefits can be achieved within 5-10 years. Results from the SEND Trial will be published and promoted on social media, press releases and websites such as Cancer Research UK (CRUK), the British Association of Oral and Maxillofacial Surgeons (BAOMS) and the British Association of Head & Neck Oncologists (BAHNO).

Benefits reported

[2 paragraphs unchanged] Clinicians have clearly engaged with the findings of Saving Faces’ open-access paper [10 words unchanged] Journal of Cancer in November 2019. To date it has been accessed 5,432 over 14,000 times, been cited 6 109 times, had 187 tweeters and 2 F1000Prime recommendations as being of special significance in its field. [1 paragraph unchanged] Two further Comments are due to be have been published by the British Journal of Cancer which demonstrate the impact of Saving Faces’ paper. The first is from the President Elect of Union International Cancer Control (UICC) and his/her colleagues from India, based in Switzerland, and writes that it will “decisively convey to the Head & Neck oncologists of the benefit of END ”. The second letter is from another group of authors in India and they write the “SEND trial adds to level 1 evidence and merits the fame of a practice-changing trial.” [1 paragraph unchanged] The 6 109 citations include a Cochrane Review (2023), a position paper by the European Association of Cranio Maxillofacial Surgery (EACMFS, 2020) and systematic review published in June 2020 in Oral Oncology that “concluded that [47 words unchanged] surgeons”. Two were letters to the Editor both published in May 2020 – one in the European Archives of Oto-Rhino-Laryngology, said “Randomised trials, like the… the … SEND trial [4] have sent out a strong message highlighting the impact of an END ” END” and the other was in Oral Oncology. There was also a news [12 words unchanged] the British Dental Journal referring to the publication of our open-access paper. The last two were Multiple observational studies between 2020 to date have also published in 2020, one about lymph node metastases in lip cancer and cited the other about sentinel lymph node biopsies. SEND trial. [3 paragraphs unchanged]

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + Civil Registrations of Death; + Demographics

Objective for processing

This Data Sharing Agreement permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling Saving Faces - The Facial Surgery Research Foundation to complete the necessary actions to enable a subsequent application to extend the Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance). Saving Faces – The Facial Surgery Research Foundation (Saving Faces) wishes to continue to hold data previously disseminated and request new data for the SEND Trial (selective neck dissection used electively). The SEND Trial is a prospective randomised controlled trial that compares two standard surgical treatments for early oral cancer with no clinical evidence of lymph node metastases in the neck. The fundamental aim and purpose of the study is to find better ways of treating patients with early mouth cancer. The following information provides background information on the purpose of the original study. No new data will be released under this version of the agreement, and this agreement allows the applicant to hold and not otherwise process any further data that has already been disseminated. This is a stand-alone project that aims to answer a specific clinical question which is to determine whether the use of a selective neck dissection used electively (SEND) on all patients presenting with T1 and T2 tumours (and no clinical evidence of neck metastasis (N0) improves survival, disease-free survival and loco-regional disease (disease restricted to a localised region of the body) control rates. T1, T2, T3, T4 refers to the size and/or extent of the main tumour. The higher the number after the T, the larger the tumour or the more it has grown into nearby tissues. Background GDPR Article 6(1)(f) is the justification of processing the data for the purposes of legitimate interests. The data controller believes this trial is the only nationwide multicentre pragmatic trial ever conducted regarding any aspect of the surgical management of head and neck and mouth cancer. It aims to answer a research question that people had tried unsuccessfully to solve for the past 40 years. Saving Faces developed and manage this clinical trial and want to find out whether an elective neck dissection (END) improves survival, disease-free survival and loco-regional disease control rates for T1/T2 N0 head and neck cancer patients. MRIS data was supplied to Saving Faces - The Facial Surgery Research Foundation by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "MRIS1131 The Role of Selective Neck Dissection Used Electively in Patients". The answer to this research question is designed to benefit patients' and society as a whole, through facilitating better healthcare in the UK. The Saving Faces study entitled The Role of Selective Neck Dissection Used Electively in Patients aims to establish whether selective neck dissection in addition to resection of the primary tumour increases survival when compared with resection of the primary alone, among patients with early oral squamous cell carcinoma who have no clinical or radiological evidence of neck metastases. Additionally the trial aims to determine how selective neck dissection (SEND) and complex reconstruction affect quality of life (QOL) and whether the use of SEND on all patients presenting with tumorus measuring 1-3cms and clinically N0 necks represents a cost-effective use of resources. To determine the lawfulness of processing the data for these legitimate interests, Saving Faces Ltd. has undertaken a Legitimate Interests Assessment (LIA) and determined that: Saving Faces - The Facial Surgery Research Foundation will also use the pathology results to try to identify risk factors for metastasis so that in the future elective neck dissection could be reserved for only those patients with an increased risk of neck metastasis based on their primary site pathological markers. i. The processing is necessary for the purpose: The processing of data is necessary as the study team would not be able to calculate survival, disease-free survival and loco-regional disease control rates for T1/T2 N0 head and neck cancer patients without collecting health and mortality data. The study team will use the minimum amount of personally-identifiable information possible. The study team could not achieve the same purpose without the processing of this data. Mortality data from NHS Digital is the most accurate source of data for this purpose. The study team anticipate that a few patients (<5%) will be lost to follow up and there is no other way of determining their survival status. There are no alternative, less intrusive ways of achieving the study purpose. ii. The interests of the individual data subjects do not override the legitimate interest: Data is collected directly from the individual or from health records. The study team remind the patients of this when they are asked to complete questionnaires. The data requested under this Agreement from NHS Digital was made clear at the time of consent and is mentioned in the consent form. The data has been collected since 2007 to now. The intended purpose and method is widely understood and patients have the opportunity to ask questions at all stages throughout the study. The study do not use any new or untried methods. When the study was being developed, the study team sought patient and public involvement so there has been input and consultation from external sources. The expectations are acceptable to participants of the study. iii. The processing is proportionate to the purpose: The mission of Saving Faces is to educate, fund and lead research into reducing the incidence of facial injuries, disorders and diseases including oral cancer. The study team will use the data collected from patients who have consented to participate in this study to follow up their health status. No third parties benefit from the processing. The wider public benefits are the potential to improve survival, disease-free survival and loco-regional disease control rates for head and neck cancer patients worldwide. These benefits are hugely important as 369,000 patients are diagnosed with OSCC (oral squamous cell carcinoma) worldwide each year. If the study team could not access the data requested under this Agreement, then there would be no way to answer this important research question that people have tried unsuccessfully to solve for the past 40 years. The data is not used for any automated decision-making, including profiling. The study team comply with guidelines from: · Health Research Authority · Research Ethics Committee · R&D (Joint Research Management Office (JRMO) for Barts Health NHS Trust and Queen Mary University of London) · General Data Protection Regulation (GDPR) · Data Protection Act 2018 (DPA 2018) · Good Clinical Practice (GCP) · UK Policy Framework for Health and Social Care Research The data controller engaged public and patient involvement (PPI) relating to SEND and other head and neck cancer projects during the setting up of the study. Since recruitment closed, the findings of the study have been disseminated via newsletters to the participants and also published on the study website. The data controller's website is regularly updated with news regarding the SEND study. The findings will enable surgeons for the first time to provide clear evidence regarding the benefits and impact of elective neck dissection for their patients thereby enabling patients to participate more effectively with decision-making regarding their treatment. In addition, the data controller is processing under GDPR Article 9(2)(j). This clinical trial is of public interest as it has the potential to improve survival, disease-free survival and loco-regional disease control rates for head and neck cancer patients. The findings will enable surgeons for the first time to provide clear evidence regarding the benefits and impact of END for their patients thereby enabling patients to participate more effectively with decision-making regarding their treatment. The trial has been closed to new patient recruitment since 2015 but due to the findings published in 2019 showing, that patients with early mouth cancer who have resection of the cancer in the mouth and elective neck dissection (END) at the same time have a survival benefit of 30% compared to patients who only have resection of the mouth cancer leaving the neck glands untouched, there is reason to follow up patients for 10 years due to the risk of the cohort of patients getting new tumours. Saving Faces can then compare results of studies on the tissue that Saving Faces hold from these patients to identify tissue markers that differ between those that develop new tumours with those that don’t. Results of the studies in the future may deliver biopsy or blood results that risk ratify for those patients that need radical surgery and radiotherapy and those that don’t. The cohort consists of patients diagnosed with T1/T2 N0 OSCC (oral squamous cell carcinoma) who have consented to be randomised to resection of the tumour only or resection with neck dissection. An additional cohort of T1/T2 N0 patients who did not wish to enter the randomised trial or who were not considered to be clinically suitable for randomisation have consented to be followed up. The main aims and purpose of the study are: 1. To determine whether the use of a selective neck dissection used electively (SEND) on all patients presenting with T1 and T2 tumours and no clinical evidence of neck metastasis (N0) improves survival, disease-free survival and loco-regional disease control rates. 2. To determine how SEND and complex reconstruction affect quality of life (QoL) and mental health. 3. To determine whether the use of SEND on all patients presenting with T1 and T2 tumours and clinically N0 necks represents a cost-effective use of resources. The main aims have been analysed and reported on but there are several subsidiary aims that still need work. Details of these subsidiary aims that are ongoing are: 1. Disease-free survival 2. Local and regional recurrence 3. Completeness of resection at the primary site. 4. Patients’ Quality of Life (EORTC QLQ-30 & H&N module) at 6, 12 and 24 months from treatment. 5. Costs to NHS, patients and carers/families. Incremental cost per life year saved and/or per quality adjusted life year (QALY). The original study requested data for four years from the date of consent in 2011 until 2015. In October 2015 the data controller requested an extension of the study from 30th April 2015 to 31st July 2020, to allow for 5 year follow up of consented patients at all sites. More recently Saving Faces has obtained ethical approval for a further 5 years follow-up (ten years altogether) until July 2025. Under this Agreement, Saving Faces require access to date and cause of death in relation to the cohort. The date and cause of death are used to calculate overall survival for the patients and find out the cause of death to determine whether the death was related to their cancer or their treatment for the cancer. The data are also used to determine the efficacy and safety of the treatments and to identify and quantify risk and protective factors. Saving Faces request identifiable data so that data can be linked to the correct patient and determine risk factors from their medical history. Patients were recruited from 27 hospitals across the UK as the study aimed to recruit a sample that is, as far as possible, representative of all UK head and neck cancer treatment centres and patients. The results are therefore readily generalisable across multiple UK hospitals in a routine surgical cancer setting, including those who treat smaller patient numbers. Mortality data from NHS Digital is the most accurate source of data for this purpose. The data controller anticipates that they will have lost contact with a few patients (<5%), and there is no other way of determining their survival status. There are no alternative, less intrusive ways of achieving the study purpose. The data fields requested under this Agreement have been reviewed by the data controller in line with data minimisation guidance. Under this Agreement the sole Data Controller is Saving Faces and the Data Processors are Saving Faces and University College London (UCL). Under previous iterations of this Agreement UCL were not included as a data processor, but moving forward there will be a trial statistician involved in the study who is a substantive employee of UCL and not employed by the data controller. For clarity the department with UCL where the trial statistician is employed is called 'The Cancer Research UK & UCL Cancer Trials Centre', this is based at and run by UCL, not Cancer research UK. There is a Data Processing Agreement in place between Saving Faces and the study’s trial statistician who is based at UCL. The statistician is not responsible for making any decisions pertaining to the collation or processing of data under this Agreement and UCL are therefore not determined to be a data controller under this Agreement. The SEND Trial has previously been funded by Cancer Research UK (CRUK) and other donors. However, current funding is provided internally by the data controller, Saving Faces. CRUK are not, nor have ever been listed as a data controller under this Agreement, as they are not responsible for any decision making regarding the data under this Agreement. The Joint Research Medical Office (JRMO) for Queen Mary University London (QMUL and St Bart's Health, are sponsor for the trial and are listed in various supporting documentation. The data controller has confirmed that the study sponsor act in an advisory manner and review documentation such as ethics and protocols before they are submitted to the relevant authorities. They do not however make any decisions regarding how the study is run, what data is collected and how the data is processed. They are therefore not acting as a data controller for the data under this Agreement.

Processing activities

Under this Agreement, the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement. • As part of this study, Saving Faces and participating sites in the study collected identifiable patient data on paper Case Report Forms which is then submitted to Saving Faces, the Trial Centre, via post. The study data, including data provided by NHS Digital under previous agreements, are currently held by Saving Faces - The Facial Surgery Research Foundation • Saving Faces processes the data at every stage – the identifiable data is in the form of patient consent forms and patient identification logs that are kept in paper form and on an encrypted storage device. These are stored securely in locked cabinets or a fireproof safe of which only the Trial Coordinator and Chief Investigator have access to. All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data). • For this Data Sharing Agreement, Saving Faces will provide NHS Digital with identifying demographics: forename, surname, date of birth and NHS number of patients to be flagged. No new or further data will be provided under this version of the agreement. A short term extension is in place as a pragmatic approach to enable legal retention of already disseminated data. This agreement allows retention of data, but not permission to otherwise process it. • NHS Digital provides health data – date and cause of death as well as the personal identifiable data: forename, surname, date of birth and NHS number so that Saving Faces can ensure the correct information is linked to the correct patient. If the data provided by NHS Digital differs to the data held by Saving Faces, the study records are updated to replace incorrect records with the latest data from NHS Digital. • Saving Faces then pseudonymises the identifiable data from NHS Digital by using the assigned patient ID, site code and initials and enters that on to paper case report forms and into an electronic trial database. • Saving Faces requires identifiable data (forename, surname, date of birth, NHS number) for the purpose of mortality flagging. Saving Faces receive patient consent forms by post where necessary and also maintain patient identification logs in both paper form and on an encrypted storage device. Saving Faces also receives pseudonymised data in the form of completed paper case report forms from participating sites and this data is entered into the trial database. • A copy of the pseudonymised data is then shared with The Cancer Research UK & UCL Cancer Trials Centre Cancer Institute within University College London (UCL). Electronic pseudonymised data is extracted from the trial database by the Trial Co-ordinator in accordance with the Data Sharing Agreement. The UCL trial statistician receives an electronic copy of the entire pseudonymised trial database to perform the statistical analysis required. The trial statistician returns outputs which are of aggregate data and not on an individual patient level. The pseudonymised data is transferred to UCL securely by extracting the data and storing it on an encrypted USB storage device and transported to the trial statistician at UCL who is responsible for the statistical analysis by means of courier. The mortality data is checked carefully to ensure that it relates to the correct patient and is then added to the pseudonymised data in the trial database (diagnosis, treatment, follow up etc), which is kept on a stand alone laptop that is not connected to the internet. The combined data in the trial database are transferred to the trial statistician on a storage device and then analysed to ensure the correct calculation of disease free and overall survival for the patient and to determine risk and protective factors. The data is only linked to data that Saving Faces has collected within the scope of the SEND Trial with the patient’s consent. The trial collects: patient demographics, cancer diagnosis, cancer treatment, follow up data including any recurrences or new primaries and any treatment outcome such as death or lost to follow up. Saving Faces will not link the data with any data other than mortality data obtained from NHS Digital. There is no requirement to re-identify patients. Only authorised members of the SEND Trial study team who are substantive employees of Saving Faces, and the trial statistician who is a substantive employee of UCL, are allowed to carry out data processing and they are trained in Good Clinical Practice and Information Security. Only the Chief Investigator, Trial Co-ordinator and the Clinical Research Manager, and the UCL trial statistician can access the data. The data consists of: • Patient consent forms and patient identification logs that are kept in paper form and on an encrypted storage device • Paper-based records of SEND and other consented trial participants and patients who have been screened for eligibility including pseudonymised case report forms and pseudonymised pathology and other medical reports relating to the study treatment. • The SEND trial database is written in Microsoft Access 2004. It is password protected within an encrypted external hard drive and used on a stand-alone laptop without any connection to an outside network. • Backup copies will be protected on encrypted storage devices in a locked fireproof safe. • Data will be extracted from the SEND eCRF database and stored on an encrypted storage device and transported to the trial statistician by means of courier. This data is extremely valuable and has already been used for one highly cited paper in the top 5% of all scientific papers that have ever been published. The data is expected to change clinical practice and will be used by Saving Faces for many more papers. It is possible that other organisations may wish to study the data and however they will be instructed to apply to Saving Faces and in addition make a separate application to NHS Digital in order to use the data. In any case, the data under this Agreement will not be shared with any other organisation unless a successful Data Sharing Agreement with NHS Digital is in place.

Expected output

This Agreement permits the secure retention of the data only and no other processing. As a result of the data processing, Saving Faces will produce a number of papers that, subject to acceptance, will be published in peer-reviewed academic or clinical journal. An initial open-access paper was published in the British Journal of Cancer in October 2019. As well as reporting the SEND prospective randomised trial and a parallel prospective study of patients who refused randomisation, the paper included a meta-analysis of the 5 previous trials and the SEND study to produce a complete evidence base. Saving Faces will continue to present results at international and public conferences. No new outputs will be produced under this Data Sharing Agreement. The results of the final analysis will be published at the end of the study, which is anticipated to be in 2025. The results will also be disseminated and presented at relevant conferences, for example at the British Association of Oral and Maxillofacial Surgeons’ Annual Scientific Meeting. Saving Faces findings will also be publicised on relevant media such as the Saving Faces’ website and social media channels. The Saving Faces' Chief Executive is invited to attend and speak at many events and also give interviews to the press, including newspapers, radio and TV and will speak of this research at relevant opportunities. Other papers relating to patient demographics, pathology, mortality, health economics and quality of life are also planned between now and the end of the study. No new or further data will be provided under this version of the agreement. A short term extension is in place as a pragmatic approach to enable legal retention of already disseminated data. This agreement allows retention of data, but not permission to otherwise process it. The data processing outputs will also inform the reports that are required under Saving Faces’ clinical trial obligations, such as regular reports to funders, the Health Research Authority, Ethics committee, and sponsor. All outputs will contain only data that are aggregated, with small number suppression. The dissemination activities will target an audience of researchers, scientists, innovative technology-focused organisations, research participants. Activities should also reach beyond the scientific community to engage with policy makers. The aim of the dissemination activities shall be two-fold: to enable the engagement with the scientific and policy-making communities / to ensure that knowledge developed by the research can benefit these communities. These outputs will only ever involve the use of aggregated data with small numbers suppressed. The results from the SEND Trial will be published in medical and scientific journals, disseminated on the Saving Faces website and newsletters, other websites including Cancer Research UK (CRUK), the British Association of Oral and Maxillofacial Surgeons (BAOMS) and the British Association of Head & Neck Oncologists (BAHNO). Saving Faces will publicise and promote the research on social media, conferences, talks, presentations and send out a press release to the media such as newspapers, radio and TV. Many outputs have already been produced from the data obtained under this Agreement. Further outputs from the study will consist of research publications, in open-access format wherever possible, which are intended to inform clinical and patient decision-making. Conference presentations and social media will also be used to disseminate the results. The process of reviewing national guidelines has already begun with input from third parties – a paper written by the European Association of Cranio Maxillofacial Surgery (EACMFS) Head & Neck Oncology Group recommending the use of elective neck dissection for all T1/T2 N0 head and neck cancer patients has been submitted for publication and this will confirm the guidelines in Europe. Another paper has been submitted to the Journal of the National Comprehensive Cancer Network (JNCCN) in the US which also supports Saving Faces’ findings and this may lead to National Comprehensive Cancer Network (NCCN) guidelines being changed.

Expected measurable benefits

This Agreement permits the secure retention of the data only and no other processing. Sharing this data will hopefully allow clinicians and patients to make better informed choices based on high quality Level 1 evidence regarding their treatment options with the potential to save thousands of lives worldwide. Level 1 evidence is evidence obtained from at least one properly designed randomised controlled trial, which the SEND Trial is. Saving Faces also conducted a meta-analysis of the 5 previous T1/T2 N0 trials and the SEND study to produce a complete evidence base. The study has the potential to change clinical practice and national guidelines worldwide. These guidelines may include the UK’s National Institute for Health and Care Excellence (NICE) guidelines and the US National Comprehensive Cancer Network (NCCN) guidelines. The British Journal of Cancer paper included for the very first time evidence on adverse events, resource use and quality of life outcomes enabling patients to make informed choices about the treatment that was offered balancing the survival benefit of END against any adverse events and Quality of Life (QoL) outcomes. The outputs will hopefully provide evidence to inform treatment choice for T1/T2 N0 head and neck cancer patients as the study has shown that an elective neck dissection will improve overall survival and disease free survival. The legitimate interest is fulfilled as the research question of whether an elective neck dissection improves overall survival, disease-free survival and loco-regional disease control rates for T1/T2 N0 head and neck cancer patients is answered, and therefore can help inform treatment choice, and may have the potential of changing national guidelines and clinical practice worldwide. All patients signed a detailed consent form based on a comprehensive information sheet. It is expected that 21,000 patients lives could be saved worldwide each year. This is a conservative estimate based on 369,000 patients diagnosed with OSCC (oral squamous cell carcinoma) worldwide each year (reported in Saving Faces’ open-access paper https://rdcu.be/bVfLH). Approximately 30% (information from Public Health England cancer registries) of new head and neck cancer diagnoses will likely be T1/T2 N0 patients which is around 110,700 patients. A third of these, 36,900, will likely benefit from having a neck dissection. Some surgeons may still not offer the neck dissection treatment while it is not part of the national guidelines, and some patients may not opt for the more aggressive treatment even if it is offered, hence Saving Faces publicised the figure of 21,000 patients worldwide each year. These actions will be carried out by Saving Faces, Cancer Research UK (CRUK), the British Association of Oral and Maxillofacial Surgeons (BAOMS) and the British Association of Head & Neck Oncologists (BAHNO) in collaboration with head and neck cancer patient groups. These groups are likely to be local groups within hospital settings that Saving Faces can ask for input rather than dissemination. Other third parties may also contribute to having the national guidelines reviewed. These include members of the head and neck surgeon community and clinicians. Saving Faces expect that these benefits can be achieved within 5-10 years.

Benefits reported

No new or further data will be provided under this version of the agreement. A short term extension is in place as a pragmatic approach to enable legal retention of already disseminated data. This agreement allows retention of data, but not permission to otherwise process it. The outputs previously produced using the data under this Agreement have influenced international guidelines with regards to elective neck dissection surgery. Current results have been widely circulated to the head and neck surgeon community both in the UK and abroad and have resulted in a change of surgical practice in favour of elective neck dissection for T1/T2 N0 patients. Clinicians have clearly engaged with the findings of Saving Faces’ open-access paper as it was the top downloaded paper in the British Journal of Cancer in November 2019. To date it has been accessed 5,432 times, been cited 6 times, had 187 tweeters and 2 F1000Prime recommendations as being of special significance in its field. The Chair of the British Association of Oral and Maxillofacial Surgeons (BAOMS) had a Comment published in The Operating Theatre Journal in November 2019 saying that as a result of this research, oral and maxillofacial surgeons “have the evidence about the risks and benefits of removing the neck glands in early mouth cancer. This information will help patients participate in decisions about their treatment.” Two further Comments are due to be published by the British Journal of Cancer which demonstrate the impact of Saving Faces’ paper. The first is from the President Elect of Union International Cancer Control (UICC) and his/her colleagues from India, and writes that it will “decisively convey to the Head & Neck oncologists of the benefit of END ”. The second letter is from another group of authors in India and they write the “SEND trial adds to level 1 evidence and merits the fame of a practice-changing trial.” The SEND Trial has been presented at many national and international conferences and public events over the last 15 years during its development and progress culminating with Keynote lectures in the USA in 2017, and India and the European conference in 2018. An initial paper was published in the British Journal of Cancer on the 15th October 2019 (the article is online with open-access and can be found at https://rdcu.be/bVfLH). The results were widely disseminated on the Saving Faces’ website, on Saving Faces’ social media, local and national radio, including an interview with Saving Faces' Chief Executive on the BBC Radio 4 Today programme on the 24th October 2019. The 6 citations include a systematic review published in June 2020 in Oral Oncology that “concluded that END was associated with higher overall survival rates” and “Our results are supported by a large multi-centre UK study by Hutchinson [sic] et al. [45] which reported outcomes in 250 randomized patients… The SEND study recruited patients with a wide variety of centres operated on by different surgeons”. Two were letters to the Editor both published in May 2020 – one in the European Archives of Oto-Rhino-Laryngology, said “Randomised trials, like the… SEND trial [4] have sent out a strong message highlighting the impact of an END ” and the other was in Oral Oncology. There was also a news article published in November 2019, which was Mouth Cancer Action Month, by the British Dental Journal referring to the publication of our open-access paper. The last two were observational studies also published in 2020, one about lymph node metastases in lip cancer and the other about sentinel lymph node biopsies. This research has also given surgeons the tools to detect some oral cancers much earlier. Surgeons worldwide now have evidence on which form of surgery is better suited to an individual patient. Patients therefore benefit by being offered more appropriate treatment based on their individual diagnosis, meaning they are less likely to need multiple surgeries. The SEND study compared two standard treatments for early mouth cancer. Its findings showed that one method cures 30% more patients. This means that every year 30,000 more patients worldwide will be cured as a result of the SEND Study results and at least 350 of these will be British. Mouth cancer and its treatment can adversely affect speech, eating and appearance. This research also looked at the social, emotional, functional outcomes and resource use of the two different treatments.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

MRIS data was supplied to Saving Faces - The Facial Surgery Research Foundation by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "MRIS1131 The Role of Selective Neck Dissection Used Electively in Patients". This Data Sharing Agreement permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling Saving Faces - The Facial Surgery Research Foundation to complete the necessary actions to enable a subsequent application to extend the Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance). This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted. Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required. [2 paragraphs unchanged] MRIS data was supplied to Saving Faces - The Facial Surgery Research Foundation by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "MRIS1131 The Role of Selective Neck Dissection Used Electively in Patients". [1 paragraph unchanged] Saving Faces - The Facial Surgery Research Foundation will also use the pathology results to try to identify risk factors [19 words unchanged] increased risk of neck metastasis based on their primary site pathological markers.

Processing activities

Under this Agreement, the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement. The study data, including data provided by NHS Digital under previous agreements, are currently held by Saving Faces - The Facial Surgery Research Foundation [2 paragraphs unchanged]

Expected output

This Agreement permits the secure retention of the data only and no other processing. No new outputs will be produced under this Data Sharing Agreement. [1 paragraph unchanged] • To determine whether the use of a selective neck dissection used electively (hereafter referred to as SEND) on all patients presenting with T1 and T2 tumours and no clinical evidence of neck metastasis (N0) improves survival, disease-free survival and loco-regional disease control rates. • To determine how SEND and complex reconstruction affect quality of life (QoL) and mental health. • To determine whether the use of SEND on all patients presenting with T1 and T2 tumours and clinically N0 necks represents a cost-effective use of resources.

Expected measurable benefits

No new or further data will be provided under this version of the agreement. A short term extension is in place as a pragmatic approach to enable legal retention of already disseminated data. This agreement allows retention of data, but not permission to otherwise process it. This Agreement permits the secure retention of the data only and no other processing. Sharing this data allows clinicians and patients make better informed choices based on high quality Level 1 evidence regarding their treatment options with the potential to save thousands of lives worldwide. Saving Faces have published one paper titled 'Nationwide randomised trial evaluating elective neck dissection for early stage oral cancer (SEND study) with meta-analysis and concurrent real world cohort' in the British Journal of Cancer in October 2019.

Unchanged: Benefits reported.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

[5 paragraphs unchanged] The role of selective neck dissection used electively in patients with early oral squamous cell carcinoma (1−3cm primary size) and no clinical evidence of lymph node metastases in the neck (N0) The Saving Faces study entitled The Role of Selective Neck Dissection Used Electively in Patients aims to establish whether selective neck dissection in addition to resection of the primary tumour increases survival when compared with resection of the primary alone, among patients with early oral squamous cell carcinoma who have no clinical or radiological evidence of neck metastases. Additionally the trial aims to determine how selective neck dissection (SEND) and complex reconstruction affect quality of life (QOL) and whether the use of SEND on all patients presenting with tumorus measuring 1-3cms and clinically N0 necks represents a cost-effective use of resources. The trial aims to establish whether selective neck dissection in addition to resection of the primary tumour increases survival when compared with resection of the primary alone, among patients with early oral squamous cell carcinoma who have no clinical or radiological evidence of neck metastases. Additionally the trial aims to determine how selective neck dissection (SEND) and complex reconstruction affect quality of life (QOL) and whether the use of SEND on all patients presenting with tumors measuring 1-3cms and clinically N0 necks represents a cost-effective use of resources. [1 paragraph unchanged]

Expected output

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted. No new or further data will be provided under this version of the agreement. A short term extension is in place as a pragmatic approach to enable legal retention of already disseminated data. This agreement allows retention of data, but not permission to otherwise process it. No further outputs of the data are permitted to be created under this version of the agreement. • To determine whether the use of a selective neck dissection used electively (hereafter referred to as SEND) on all patients presenting with T1 and T2 tumours and no clinical evidence of neck metastasis (N0) improves survival, disease-free survival and loco-regional disease control rates. • To determine how SEND and complex reconstruction affect quality of life (QoL) and mental health. • To determine whether the use of SEND on all patients presenting with T1 and T2 tumours and clinically N0 necks represents a cost-effective use of resources.

Expected measurable benefits

MRIS data was supplied to Saving Faces - The Facial Surgery Research Foundation by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "MRIS1131 The Role of Selective Neck Dissection Used Effectively in Patients". No new or further data will be provided under this version of the agreement. A short term extension is in place as a pragmatic approach to enable legal retention of already disseminated data. This agreement allows retention of data, but not permission to otherwise process it. This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted. Sharing this data allows clinicians and patients make better informed choices based on high quality Level 1 evidence regarding their treatment options with the potential to save thousands of lives worldwide. Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. Saving Faces have published one paper titled 'Nationwide randomised trial evaluating elective neck dissection for early stage oral cancer (SEND study) with meta-analysis and concurrent real world cohort' in the British Journal of Cancer in October 2019. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required.

Benefits reported

Not stated in the previous version; added here.

No new or further data will be provided under this version of the agreement. A short term extension is in place as a pragmatic approach to enable legal retention of already disseminated data. This agreement allows retention of data, but not permission to otherwise process it.

Unchanged: Processing activities.