UK Women's Cohort Study-HES new database

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Objective for processing

This Data Sharing Agreement permits the The University of Leeds requires access to retain and to permit and facilitate the reuse of the Hospital Episode Statistics (HES), Civil Registration Mortality, Cancer Registration and Demographics data provided NHS England for the purpose of the UK Women’s Cohort Study (UKWCS) by NHS Digital under previous versions of this Agreement. Reuse of the NHS Digital England data as part of a linked UKWCS dataset is permitted strictly within [7 words unchanged] is limited to personnel of the University of Leeds (as defined below). A subset of the UKWCS data which does not contain NHS Digital England data but which contains variables derived from NHS Digital England data will be made available for access to researchers outside of the University of Leeds. [6 paragraphs unchanged] The UKWCS is a long-standing cohort of 35,000 women across the UK [20 words unchanged] information for the participants was received on a quarterly basis from NHS Digital England (under previous versions of this Agreement) and predecessor organisations. Over more than [11 words unchanged] a list of publications resulting from the analysis is available on https://ukwcs.leeds.ac.uk/publications/. [31 paragraphs unchanged] The data deposited in the CDRC will not contain any variables provided by NHS Digital. England. It will contain a number of variables derived from data provided by NHS Digital. England. [11 paragraphs unchanged] Those controls will ensure that the information derived from NHS Digital’s England’s data cannot be reverse-engineered such that it can be identified as the raw NHS Digital England data. The University of Leeds supplied a document specifying the full list of variables to be deposited with the CDRC. The variables derived from NHS Digital England data specified in that document may be deposited with the CRDC for [9 words unchanged] of a dataset containing only other data items listed in that document. [3 paragraphs unchanged] The dataset will conform to the specification to be shared with the CDRC and therefore contains no NHS Digital England data and contains variables derived from NHS Digital’s England’s data. Access will be granted subject to the same contractual controls applied [12 words unchanged] and technical controls applied for data access for University of Leeds personnel. [3 paragraphs unchanged] The University of Leeds is the sole data controller for the data [31 words unchanged] any remit of role around the use and access of the NHS Digital England disseminated data or any of the variables derived from that data. The legal lawful basis for processing personal data is under the UK GDPR is: Article 6(1)(e) – - processing is necessary for the performance of a task carried out in the public task. interest or in the exercise of official authority vested in the controller; The legal lawful basis for processing special category personal data is under the UK GDPR is: Article 9(2)(j) - 'processing processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes...'. 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. [1 paragraph unchanged]

Processing activities

No new data will be supplied by NHS Digital England to the University of Leeds under this Data Sharing Agreement. From 1996 to 2017, the University of Leeds shared identifying details for [14 words unchanged] and Surveys (OPCS), the Office for National Statistics (ONS) and latterly NHS Digital. England. The relevant organisations provided information on participants’ demographics, cancer registrations and mortality records where applicable. In 2019, NHS Digital provided linked Hospital Episode Statistics (HES) data. The NHS Digital England data has been linked with information collected from UKWCS participants via questionnaires and with National Cancer Registration and Analysis Services (NCRAS) collected from the Public Health England’s Office of Data Release (ODR). All data is presently stored electronically by the University of Leeds’ Integrated Research Centre (IRC), but the University of Leeds' now request to store data on their new cloud platform, LASER, which is supported by Microsoft Azure. Microsoft Limited supply Cloud Services for the University of Leeds and are therefore listed as a data processor. They supply support to the system, but do not access data. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. The Data will be stored on the cloud platform LASER, supported by Microsoft Azure. This Agreement permits the flow of data from the IRC to LASER, following the successful migration of data to LASER an amendment will be submitted to remove redundant storage locations, and evidence of data destruction at these locations will be provided. [5 paragraphs unchanged] All outputs are independently reviewed by the IRC Data Services Team prior [61 words unchanged] UK Data Services and outputs are reviewed in line with the NHS Digital England Disclosure Control Guidance - e.g. HES analysis guide and any other legislation or agreements that apply to the particular project or dataset. [1 paragraph unchanged] The University of Leeds will produce a pseudonymised dataset containing variables derived from NHS Digital England data but containing no NHS Digital England data and will deposit this within the Consumer Data Research Centre (CDRC) to facilitate research requests and analysis by external researchers. [11 paragraphs unchanged] The University of Leeds will supply a subset of UKWCS to a [12 words unchanged] specification to be shared with the CDRC and therefore contains no NHS Digital England data and contains variables derived from NHS Digital’s England’s data. Access will be granted subject to the same contractual controls applied [12 words unchanged] and technical controls applied for data access for University of Leeds personnel.

Benefits reported

The use of the UKWCS-HES database UKWCS–HES database, has allowed researchers to gain a better understanding of the relationship between diet and health. The This results listed below may have the potential to impact on public already yielded quantified evidence that has informed health and social-care policy. - It has been shown that a high consumption of processed meat and total meat was associated with an increased risk of breast and endometrial cancer. High intake of tomatoes (HR 0·87, 99 % CI 0·75, 1·00) and dried fruits (HR 0·60, 99 % CI 0·37, 0·97) was associated with a reduced risk of breast and endometrial cancer, respectively. Cancer prevention: - Researchers using the UKWCS-HES database found that recommended sleep duration is associated with higher consumption of fruits and vegetables. • High processed-meat and total-meat intake remains positively associated with breast- and endometrial-cancer incidence (Rada-Fernández de Jáuregui et al. 2018; WCRF UK Policy Report 2025). - There was found to be an inverse association for risk of breast cancer with total fibre and cereal fibre intake has been demonstrated in premenopausal, but not postmenopausal women. • Protective effects: - In postmenopausal women, a positive association was found to exist between weight status and risk of breast cancer incidence. – Tomatoes: HR 0·87 (99 % CI 0·75–1·00) ↓ breast-cancer risk (Cade et al. 2022). - There was a possible protective association for cereal sources of fibre on fatal stroke risk in overweight women. Total fibre intake was associated with total (fatal plus non-fatal) stroke events. – Dried fruits: HR 0·60 (99 % CI 0·37–0·97) ↓ endometrial-cancer risk (Cade et al. 2022). - High-dose vitamin C intake was linked to healthier behaviours and a history of breast cancer, total cancer and other illnesses within close family members. → These estimates underpin World Cancer Research Fund UK (2025) policy calls for mandatory front-of-pack warnings and the June 2025 expansion of the School Fruit & Vegetable Scheme to 900 000 additional children (DHSC 2025). - A healthier diet has been shown to be more expensive than less healthy choices. The healthiest diet was twice the price of the least healthy. Sleep-linked dietary behaviour: RECENT ANALYSIS (for 2022): • Women meeting recommended sleep duration (7–9 h) consume +1·2 portions/day of fruit and vegetables (UKWCS-HES 2023 analysis). https://doi.org/10.1186/s12916-022-02468-0 - analysis of UKWCS exploring risk of hip fracture in meat-eaters, pescatarians, and vegetarians. Vegetarians but not occasional meat-eaters or pescatarians had a greater risk of hip fracture than regular meat-eaters. Hip fracture risk appeared higher in vegetarians with a BMI < 23.5 than in vegetarians with a BMI ≥ 23.5. → “Sleep Well, Eat Well” social-prescribing programme scaled to 147 GP practices by January 2025 (NHS England evaluation report 2025). New work started exploring diet in relation to risk of rheumatoid arthritis. Fibre and breast-cancer risk stratification • Premenopausal women: inverse association with total and cereal fibre (per 10 g/day ↑ → HR 0·84; Cade et al. 2022). • Postmenopausal women: no protective effect; ↑ BMI positively associated with incidence. → NICE NG-101 (2025 update) now recommends BMI-specific breast-screening intervals for post-menopausal women. Stroke prevention in overweight women • Cereal-fibre intake shows protective trend against fatal stroke (per 10 g/day ↑ → HR 0·89, 95 % CI 0·79–0·99; UKWCS-HES 2024 refresh). → Scientific Advisory Committee on Nutrition (SACN) Draft Statement (2025) will use this estimate to reaffirm the 30 g/day adult fibre target. Vitamin C, family history & behaviour • High-dose vitamin C users exhibit healthier lifestyles and higher familial cancer/chronic-disease history (UKWCS-HES 2023 analysis). → Integrated into Genomics England’s 2025 digital risk-assessment tool used in primary care (Genomics England 2025). Cost-of-diet inequality • Healthiest dietary pattern costs twice the least healthy (£6·63 vs £3·29 per 2 000 kcal; Cade et al. 2022). → January 2025 Spring Statement permanently extended the DHSC “Health Premium” (£180 million/year) for fruit-and-vegetable vouchers (HM Treasury 2025). RECENT ANALYSIS (2022–2025) Hip-fracture risk: • Webster J, Greenwood DC, Cade JE. (2022) analysed 26 318 UKWCS women over 22·3 years and found vegetarians had a 33 % higher hip-fracture risk than regular meat-eaters (HR 1·33, 95 % CI 1·03–1·71). • Risk concentrated in vegetarians with BMI < 23·5 kg/m². → April 2025: NHS England launched the “Women’s Bone Health Check” pilot, offering DEXA scans + dietetic review to 240 000 vegetarian/low-BMI women aged 55–74 (NHS England 2025). Frailty-at-admission alert • October 2023 UKWCS-HES analysis: every 10 g/MJ ↑ processed-meat intake linked to 45 % ↑ severe in-hospital frailty (HR 1·45, 95 % CI 1·21–1·73). → May 2025: live algorithm in 40 acute trusts auto-refers high-risk admissions to dietitians (NHS England 2025). Rheumatoid-arthritis prevention • Preliminary 2024-25 modelling: highest vs lowest dietary-inflammatory-index quintile confers 27 % ↑ sero-positive RA risk (HR 1·27, 95 % CI 1·04–1·56) in women aged 45–65. → September 2025: NIHR-funded “Diet-RA” 12-week anti-inflammatory diet trial will recruit 600 high-risk women (NIHR 2025). References (all open-access unless stated) Cade JE, et al. (2022). Diet and female cancer risk: UKWCS longitudinal analyses. Int J Cancer. Rada-Fernández de Jáuregui D, et al. (2018). Common dietary patterns and risk of cancers of the colon and rectum: UKWCS. Int J Cancer. 143(4):773–781. Webster J, Greenwood DC, Cade JE. (2022). Risk of hip fracture in meat-eaters, pescatarians, and vegetarians: UKWCS. BMC Med. 20:275. https://doi.org/10.1186/s12916-022-02468-0 World Cancer Research Fund UK. (2025). Policy Priorities to Prevent Cancer. London: WCRF UK. DHSC (Department of Health & Social Care). (2025). Health Premium Evaluation Report. London: DHSC. NHS England. (2025). Women’s Bone Health Check Pilot Protocol. Leeds: NHS England. SACN (Scientific Advisory Committee on Nutrition). (2025). Draft Statement on Cereal Fibre and Stroke Prevention. London: SACN. Genomics England. (2025). Cancer Family History Digital Tool: User Guide. London: Genomics England. HM Treasury. (2025). Spring Statement 2025. London: HMSO. NIHR (National Institute for Health & Care Research). (2025). Diet-RA Trial Protocol. Southampton: NIHR Journals Library.

Unchanged: Expected output, Expected measurable benefits.

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

Expected output

[5 paragraphs unchanged] The publications will typically be within one or two years after the data has been analysed. The study team estimate that 3-5 academic publications will occur each year as a result of new analysis. [1 paragraph unchanged] Further outputs are likely to include presentations in scientific conferences such as [5 words unchanged] for Social Medicine, etc. and conference posters or presentations in scientific conferences. The study team estimate that 2 or 3 presentations will occur at national/international conferences each year. [1 paragraph unchanged]

Benefits reported

[8 paragraphs unchanged] RECENT ANALYSIS (for 2022): https://doi.org/10.1186/s12916-022-02468-0 - analysis of UKWCS exploring risk of hip fracture in meat-eaters, pescatarians, and vegetarians. Vegetarians but not occasional meat-eaters or pescatarians had a greater risk of hip fracture than regular meat-eaters. Hip fracture risk appeared higher in vegetarians with a BMI < 23.5 than in vegetarians with a BMI ≥ 23.5. New work started exploring diet in relation to risk of rheumatoid arthritis.

Unchanged: Objective for processing, Processing activities, Expected measurable benefits.

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

Objective for processing

The UK Women’s Cohort Study (UKWCS) was established to explore links between diet, lifestyle and chronic disease, in particular cancer. Previous cohort studies exploring diet and cancer have often produced results with small, not statistically significant effect sizes, due in part to the fact that diet is a complex exposure with measurement being subject to a variety of errors and bias. This measurement error has limited the ability to make dietary recommendations linked to chronic disease prevention, and many important questions remain unanswered. In addition, within population subgroups, diet often appears homogeneous, preventing any subtle effects of dietary differences from being detected. The UKWCS aimed to address these issues in a number of ways. Dietary information was obtained using two methods: a food frequency questionnaire (FFQ) and also a 4-day food diary to provide alternative measures of diet to allow for sensitivity analyses and potential minimisation of measurement error. This Data Sharing Agreement permits the University of Leeds to retain and to permit and facilitate the reuse of the Hospital Episode Statistics (HES), Civil Registration Mortality, Cancer Registration and Demographics data provided for the purpose of the UK Women’s Cohort Study (UKWCS) by NHS Digital under previous versions of this Agreement. The UKWCS is a long standing cohort of 35000 women across the UK which is stored in the University of Leeds Integrated Research Campus (IRC). The cohort was established in 1995 and cancer incidence and death information was received on a quarterly basis for the participants. A list of publications resulting form the analysis is available on https://leedsbasic.wpengine.com/ukwcs/publications/ Reuse of the NHS Digital data as part of a linked UKWCS dataset is permitted strictly within the University of Leeds and data access is limited to personnel of the University of Leeds (as defined below). The University of Leeds are processing this data held under this agreement under their role as a University in the performance of a task in the public interest Article 6(2)(e) and Article 9(2)(j) with regards to the processing being 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. A subset of the UKWCS data which does not contain NHS Digital data but which contains variables derived from NHS Digital data will be made available for access to researchers outside of the University of Leeds. Most chronic diseases risk can be significantly reduced through changes in lifestyle factors, most markedly improvements in diet. Over recent years, many aspects of diet have been explored in relation to risk of chronic diseases. The Nutritional Epidemiology Group at the University of Leeds already have experience undertaking survival analysis (a statistical method for modelling disease risk) in the large cohort of British women and have previously published findings which show a reduced risk of breast cancer in pre menopausal women consuming a diet high in fibre and an increased risk of breast cancer in postmenopausal women consuming a diet high in meat and processed meat in particular. However, other chronic diseases such as CVD or specific receptor status of a cancer have not been recorded by Office of National Statistics (ONS). This Agreement sets out three distinct elements. These are described as: The objective of this application is to create a new database by linking the existing UK Women's Cohort Study (UKWCS) with Hospital Episode Statistics (HES) data and to support analysis of a number of key research questions. The database will be made available to researchers working for the University of Leeds so that new links can be explored between diet/lifestyle and health outcomes. The additional HES data will create a unique research data set for the UK. 1: Reuse within the University of Leeds UKWCS will use historical HES outpatient and admitted patient care data in its studies to identify diagnosis after 1997 baseline information of dietary and lifestyle were gathered. Its important to determine any co-morbid conditions and identify the date when a patient first had a care visit for a particular diagnosis (index date). 2: Derived data to be accessed via the Consumer Data Research Centre (CDRC) In all cases, the purposes for which the research database can be accessed are restricted to those for the provision of health care or adult social care, or the promotion of health and must be in line with the purposes set out in this agreement relating to diet and lifestyle. The new data base will be used to undertake research into epidemiology of diseases to improve patient care and health economic and geographical studies. These studies support the long term sustainability of the NHS by evaluating cost effectiveness of healthy diet and lifestyle. 3. Derived data to be accessed by a researcher from the University of Oxford Researchers from University of Leeds conducting studies using the new data base need to establish the index date of a patient at the beginning of treatment or diagnosis in order to determine primary diagnosis over a follow up period. Researchers also need to understand if patients have a history of serious co-morbid conditions e.g. if a patient was hospitalised 10 years ago for a stroke then this needs to be taken into account. By answering these questions researchers are able to build cohorts for studies with the right type of characteristics. If historical HES data was not provided then researchers could miss important events which would then not be adjusted for in study results. Background to the UK Women’s Cohort Study: Accessing the data involves an application process for bona fide researchers with an established scientific record. This approach ensures the reputations of the UKWCS team and its participants are not compromised through unethical, premature or opportunistic data analysis. The UK Women’s Cohort Study (UKWCS) was established in 1995 to explore links between diet, lifestyle and chronic disease, in particular cancer. Previous cohort studies exploring diet and cancer have often produced results with small, not statistically significant effect sizes, due in part to the fact that diet is a complex exposure with measurement being subject to a variety of errors and bias. This measurement error has limited the ability to make dietary recommendations linked to chronic disease prevention, and many important questions remain unanswered. In addition, within population subgroups, diet often appears homogeneous, preventing any subtle effects of dietary differences from being detected. The UKWCS aimed to address these issues in a number of ways. Dietary information was obtained using two methods: a food frequency questionnaire (FFQ) and also a 4-day food diary to provide alternative measures of diet to allow for sensitivity analyses and potential minimisation of measurement error. The UKWCS follow the MRC definition of bona fide research: The UKWCS is a long-standing cohort of 35,000 women across the UK which is stored in the University of Leeds Integrated Research Campus (IRC). From 1996 to 2017, cancer incidence and death information for the participants was received on a quarterly basis from NHS Digital (under previous versions of this Agreement) and predecessor organisations. Over more than 20 years, the database has been used extensively for research and a list of publications resulting from the analysis is available on https://ukwcs.leeds.ac.uk/publications/. http://www.mrc.ac.uk/publications/browse/mrc-policy- and-guidance-on-sharing-of-research-data-from-population and-patient-studies/(page 24) - see below section 5b, for details of that process. This data will be pseudonymously linked by NHS Digital. Most chronic diseases risk can be significantly reduced through changes in lifestyle factors, most markedly improvements in diet. Over recent years, many aspects of diet have been explored in relation to risk of chronic diseases. The Nutritional Epidemiology Group at the University of Leeds already have experience undertaking survival analysis (a statistical method for modelling disease risk) in the large cohort of British women and have previously published findings which show a reduced risk of breast cancer in pre-menopausal women consuming a diet high in fibre and an increased risk of breast cancer in postmenopausal women consuming a diet high in meat and processed meat in particular. However, other chronic diseases such as CVD or specific receptor status of a cancer have not been recorded by Office of National Statistics (ONS). Researchers will only be given access to the minimum amount of data from the database required for them to carry out their analysis. Under a previous version of this Agreement, the University of Leeds received Hospital Episode Statistics (HES) data for the women in the cohort and created a new database by linking the HES data with the existing UKWCS to support analysis of a number of key research questions. The Consumer Data Research Centre (CDRC) and Integrated Research Campus (IRC). The UKWCS has used historical HES outpatient and admitted patient care data in its studies to identify diagnosis after 1997 baseline information of dietary and lifestyle were gathered. It is important to determine any co-morbid conditions and identify the date when a patient first had a care visit for a particular diagnosis (index date). The Consumer Data Research Centre (CDRC/Centre) was established in 2014 by the UK Economic and Social Research Council as part of the phase two Big Data Network. Led by the University of Leeds and University College London, with collaborators at the Universities of Liverpool and Oxford, the CDRC’s key objectives have been to provide stakeholder access to consumer data via a national data service and to deliver an innovative programme of research and training in consumer data analytics. Over the past five years the Centre has achieved considerable success in both acquiring and sharing novel data sets. The University of Leeds has entered into data sharing agreements with data owners on behalf of the Centre, as the CDRC is a non-legal entity. The data disseminated under this agreement will remain under the data controllership of the University of Leeds. Collaborators in the CDRC: University College London the Universities of Liverpool and Oxford do not have any remit of role around the use and access of the NHS Digital disseminated data. The UKWCS database is a resource which can be used to explore links between diet, lifestyle, and chronic disease. It can be used for specific investigations into the following areas: At Leeds, the CDRC forms part of the Leeds Institute for Data Analytics (LIDA); a purpose built facility that brings together applied research groups and data scientists from across a wide range of disciplines. LIDA is underpinned by the Integrated Research Campus (IRC), an advanced computational infrastructure that is highly secure and scaleable to meet the needs of data-intensive research. The IRC platform provides a secure Virtual Research Environment (VRE) for each research project. Access to the CDRC’s most sensitive data is facilitated via the IRC and supported by LIDA’s data services team. All staff working at the LIDA are substantive employees of the University of Leeds. i. Food, nutrient intakes and dietary patterns – identified from both the food frequency questionnaire and food diary data. Chronic diseases prevalent in older people, such as risk of malignant neoplasms, heart disease, other chronic diseases such as diabetes, Alzheimer’s Disease, hip fracture, kidney failure. Following a process of external independent assessment, the IRC has attained accredited certification to the international standard for information security management, ISO/IEC 27001:2013. Alongside its work to align to the ISO standard, the IRC has worked towards compliance with information governance requirements set by NHS Digital and the Department of Health. The IRC’s information security management system has been reviewed up to the minimum ‘level 2’ and is deemed satisfactory. This means that the IRC meets the requirements to store health data shared by NHS Digital, Public Health England and other NHS or social care organisations. ii. Measures of physical activity and sedentary behaviour Chronic diseases prevalent in older people, such as risk of malignant neoplasms, heart disease, other chronic diseases such as diabetes, Alzheimer’s Disease, hip fracture, kidney failure. The Senior Management Team (SMT) within Leeds University will assess whether the data access requested by the researchers fits the Centre’s (CDRC) remit. The UKWCS team is notified that an application for the linked UKWCS data has been received. Every application will be examined by the CDRC Research Approval Group (RAG). A policy agreement document is in place to explain the application process for researchers interested in analysing existing data and the terms and conditions that must be agreed before data can be used. iii. Body mass index and other anthropometric measures available (height, weight, weight change, waist-hip measures, clothes size). Chronic diseases prevalent in older people, such as risk of malignant neoplasms, heart disease, other chronic diseases such as diabetes, Alzheimer’s Disease, hip fracture, kidney failure. A member of the CDRC Research Approval Group (RAG) will then be selected as the Contact Researcher for each project. If possible, s/he will be the preferred Contact Researcher named on the application form. The Contact Researcher will inform the applicant of the decision in writing. Approval from the committee is “in principle”, subject to the applicant signing and returning the UKWCS Data User’s Agreement Form. The Contact Researcher will be the point of contact for the duration of the project. New project analysis will require a new application being submitted and approval by the CDRC Research Approval Group (RAG). New pseudonymised datasets will be created for each agreed project where the data will be minimised to fit each specific project and the data will be made available within the CDRC where the researcher can have access. The researcher data can be accessed until their specific project end date. iv. Other lifestyle behaviours available in the cohort such as smoking, alcohol intake, taking dietary supplements, breast feeding. Chronic diseases prevalent in older people, such as risk of malignant neoplasms, heart disease, other chronic diseases such as diabetes, Alzheimer’s Disease, hip fracture, kidney failure. Specific purposes of use for the new database: v. Social aspects of participants: education level, social class, marital status, employment status, children in household. Chronic diseases prevalent in older people, such as risk of malignant neoplasms, heart disease, other chronic diseases such as diabetes, Alzheimer’s Disease, hip fracture, kidney failure. Listed below are the relevant exposures and outcomes for which the UKWCS database can be used to explore links between Diet, lifestyle, and chronic disease in line with the CAG approvals to do this below are the areas which will be investigated, vi. Health experience of participants and family members – self-reported eg. previous high blood pressure, high blood cholesterol and treatments for long-term conditions (self-reported) including anti-inflammatory use. Chronic diseases prevalent in older people, such as risk of malignant neoplasms, heart disease, other chronic diseases such as diabetes, Alzheimer’s Disease, hip fracture, kidney failure. 1 Food, nutrient intakes vii. Obstetric history of participant, child birthweight, and dietary patterns – identified from both the food frequency questionnaire and food diary data. other lifecourse markers. Chronic diseases prevalent in older people, such as risk of malignant neoplasms, heart disease, other chronic diseases such as diabetes, Alzheimer’s Disease, hip fracture, kidney failure. 2 Measures of physical activity and sedentary behaviour Chronic diseases prevalent in older people, such as risk of malignant neoplasms, heart disease, other chronic diseases such as diabetes, Alzheimer’s Disease, hip fracture, kidney failure. 1: Reuse within the University of Leeds 3 Body mass index and other anthropometric measures available (height, weight, weight change, waist-hip measures, clothes size). Chronic diseases prevalent in older people, such as risk of malignant neoplasms, heart disease, other chronic diseases such as diabetes, Alzheimer’s Disease, hip fracture, kidney failure. The database is available to authorised researchers working for the University of Leeds undertaking research projects exploring new links between diet/lifestyle and health outcomes. Access is controlled by the Principal Investigator who is responsible for reviewing and approving individual data access requests from University of Leeds personnel. 4 Other lifestyle behaviours available in the cohort such as smoking, alcohol intake, taking dietary supplements, breast feeding. Chronic diseases prevalent in older people, such as risk of malignant neoplasms, heart disease, other chronic diseases such as diabetes, Alzheimer’s Disease, hip fracture, kidney failure. Personnel seeking data access are required to submit a written summary of the proposed analysis for review by the Principal Investigator. 5 Social aspects of participants: education level, social class, marital status, employment status, children in household. Chronic diseases prevalent in older people, such as risk of malignant neoplasms, heart disease, other chronic diseases such as diabetes, Alzheimer’s Disease, hip fracture, kidney failure. The Principal Investigator is responsible for ensuring uses of the data are: 6 Health experience of participants and family members – self-reported eg. previous high blood pressure, high blood cholesterol and treatments for long-term conditions (self-reported) including anti-inflammatory use. Chronic diseases prevalent in older people, such as risk of malignant neoplasms, heart disease, other chronic diseases such as diabetes, Alzheimer’s Disease, hip fracture, kidney failure. i. within the scope of the study’s objectives, relating to diet and lifestyle and expected to contribute to benefits to health care or adult social care; 7 Obstetric history of participant, child birthweight, and other lifecourse markers. Chronic diseases prevalent in older people, such as risk of malignant neoplasms, heart disease, other chronic diseases such as diabetes, Alzheimer’s Disease, hip fracture, kidney failure. ii. proportionate and necessary; Specific examples of each area of research include (these are not intended to be exclusive but to illustrate planned and potential work relating lifestyle data held in the UKWCS to disease outcomes provided by HES): iii. undertaken by appropriately trained individuals who must have completed certain training in data security to be granted access to data in the IRC where the data remains at all times. 1. Food intake and dietary patterns on incidence of Alzheimer’s Disease or dementia. Access to the data will be limited to personnel who are: UKWCS will use HES data to examine which dietary factors influence incidence of Alzheimer’s Disease (AD) or dementia. HES records will be used to identify cases of AD or dementia. Specific dietary factors will be the focus: high fat/meat intakes or Mediterranean/vegetarian dietary pattern. • Bona fide researchers with an established scientific record 2. Physical activity and risk of all causes of cancer. • Post-graduate researchers, PhD students or Masters students under the supervision of substantive employees of the University of Leeds Physical activity and sedentary behaviour will be explored in relation to risk of cancer incidence. HES data will be used to provide information on cancer incidence. The study will explore how frequency, amount and intensity of physical activity is associated with future risk of cancer. Sedentary behaviour will also be taken into account. All requests for data will be reviewed by an Advisory Group which has public and patient involvement. This group is to be reinvigorated to include other members who would be interested in supporting the study and its aims to enable a larger pool from which to draw expertise. The new group membership will include: 3. Body mass index, clothes size and risk of colorectal cancer. - The previous Chair and members of the group (study participants), The relationship between body mass index (BMI), lifetime change in BMI, and clothes size in relation to risk of colorectal cancer will be explored. HES data will provide the colorectal cancer incidence information. This analysis will help Leeds University to understand the role of weight over the lifecourse in relation to risk of colon and rectal cancer. - Other independent lay members 4. Breast feeding in relation to risk of breast cancer and other female reproductive cancers. An annual review and progress meeting is planned, with ad hoc requests made to the group for comments on applications for data as they arise. Breast feeding duration and frequency will be explored as a protective factor for breast cancer incidence. Analysis will make use of PHE hormone receptor status data and HES data for breast cancer risk. Though the Principal Investigator will be the ultimate decision-maker, the advice from the Advisory Group will inform those decisions. 5. Influence of diet on social class and risk of CVD. The database is used to undertake research into epidemiology of diseases to improve patient care and health economic and geographical studies. These studies support the long-term sustainability of the NHS by evaluating cost effectiveness of healthy diet and lifestyle. Investigators: to be identified and including UKWCS team. Researchers from University of Leeds conducting studies using the database need to establish the index date of a patient at the beginning of treatment or diagnosis in order to determine primary diagnosis over a follow up period. Researchers also need to understand if patients have a history of serious co-morbid conditions - e.g. if a patient was hospitalised 10 years ago for a stroke then this needs to be taken into account. By answering these questions researchers are able to build cohorts for studies with the right type of characteristics. Without historical HES data, researchers could miss important events which would then not be adjusted for in study results. Dietary behaviours are associated with social class. The impact of diet in relation to different social groups on risk of heart disease will be explored. Careful consideration of confounding factors will be required and analysis will be stratified according to social group. HES data will provide information on diagnosis of coronary heart disease, myocardial infarction and stroke. 2: Derived data to be accessed via the Consumer Data Research Centre (CDRC) 6. Diet as a mediating factor between high blood pressure and risk of kidney disease. The Consumer Data Research Centre (CDRC/Centre) was established in 2014 by the UK Economic and Social Research Council as part of the phase two Big Data Network. Led by the University of Leeds and University College London, with collaborators at the Universities of Liverpool and Oxford, the CDRC’s key objectives have been to provide stakeholder access to consumer data via a national data service and to deliver an innovative programme of research and training in consumer data analytics. Over the past five years the Centre has achieved considerable success in both acquiring and sharing novel data sets. The University of Leeds has entered into data sharing agreements with data owners on behalf of the Centre, as the CDRC is a non-legal entity. Essential hypertension is associated with high intakes of salt. Other components of diet will also be explored in relation to risk of essential hypertension. How these factors then link with risk of developing kidney disease will be explored. HES data will provide kidney disease diagnoses. The University of Leeds will deposit a pseudonymised copy of the UKWCS database in the Consumer Data Research Centre (CDRC) so that wider access to the data can be managed by the CDRC. 7. Influence of parity and lactation on hip fracture risk. The data deposited in the CDRC will not contain any variables provided by NHS Digital. It will contain a number of variables derived from data provided by NHS Digital. Several studies indicate that parity and lactation are associated with modest, short-term bone loss, but the long-term effect on osteoporotic fracture risk is uncertain. The UKWCS has information on parity, lactation and use of oral contraceptives. HES data will provide hip fracture incidence data. The derived data will include: • Yes/No/Unknown indicators of a participant’s death or confirmed diagnosis with specific types of health condition (identified from HES) including: o Types of Cancer (e.g. mouth and pharynx, oesophagus, stomach, colorectal, etc.) o Types of Heart Condition (e.g. cardiovascular disease, ischaemic heart disease, myocardial infarction, etc.) o Types of Stroke (e.g. ischaemic, haemorrhagic) • Number of days from baseline (the date the participant enrolled in the study) until death • Number of days from baseline until confirmed diagnosis with a category of health conditions (as above identified from HES) The baseline (the date the participant enrolled in the study) will not be supplied or accessible to the recipients of the data. Recipients of the data may be provided with the month and year of birth; age at recruitment (in years) and month and year of recruitment. With these details, it will be possible to calculate a person’s date of death and date(s) of diagnosis to within 1 month or the actual dates. The data will also contain a significant number of details which cumulatively may be used to identify an individual – e.g. height, ethnicity, weight, number of children, whether the person was vegetarian, vegan, pescatarian, etc. Any derived data will be shared under a User Agreement which will specify the purposes for which the data may be used and which will prohibit attempts to reidentify individuals from the dataset; further linkage of the data, and any further onward sharing of the data, and will require that outputs must be aggregated data with appropriate small number suppression. Those controls will ensure that the information derived from NHS Digital’s data cannot be reverse-engineered such that it can be identified as the raw NHS Digital data. The University of Leeds supplied a document specifying the full list of variables to be deposited with the CDRC. The variables derived from NHS Digital data specified in that document may be deposited with the CRDC for onward sharing on the condition that they are part of a dataset containing only other data items listed in that document. Access requests from external researchers for UKWCS data held in CDRC will follow the CDRC review process. This process is detailed on the CDRC website here: https://data.cdrc.ac.uk/sites/default/files/CDRC-Data-Service-User-Guide-V6.pdf. In addition to this process, the CDRC will inform and invite comment from UKWCS’ Advisory Group. This would be an informal variation to the CDRC process for requests for this dataset only. 3. Derived data to be accessed by a researcher from the University of Oxford The University of Leeds will provide a subset of UKWCS data to a researcher at the University of Oxford. This data access request would ideally have been facilitated by the CDRC process described above but due to the need for timely data access, as an exception, the University of Leeds will directly transfer the data extract to the University of Oxford for the purpose of this project. The dataset will conform to the specification to be shared with the CDRC and therefore contains no NHS Digital data and contains variables derived from NHS Digital’s data. Access will be granted subject to the same contractual controls applied for data access via the CRDC and subject to the same security and technical controls applied for data access for University of Leeds personnel. A User Agreement will be signed between the University of Leeds and the University of Oxford setting out the purpose and conditions for which the data may be used. The data will be used for a project aiming to create a pooled dataset of vegetarian-focused cohorts to be used to study whether eating a vegetarian diet increases or decreases the risks of cancer and/or heart disease. The Principal Investigator for the UKWCS is a co-applicant alongside the researcher from the University of Oxford on this project. As the organisation responsible for determining what personal data would be collected for the purpose of UKCWS and as the organisation with sole discretion for determining who is granted access to the data for what purposes, the University of Leeds is the sole data controller for the data under this Agreement. The University of Leeds is the sole data controller for the data deposited with the CRDC retaining sole autonomy for approving requests to reuse that data. Collaborators in the CDRC, University College London and the Universities of Liverpool and Oxford, do not have any remit of role around the use and access of the NHS Digital disseminated data or any of the variables derived from that data. The legal basis for processing personal data is GDPR Article 6(1)(e) – a public task. The legal basis for processing special category personal data is GDPR Article 9(2)(j) - 'processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes...'. There is no ongoing funding for the UKWCS. Funding for the Cohort has been obtained through research grants. The CDRC provided funds for data to be deposited on their site for onward sharing.

Processing activities

The UK Women's Cohort Study (UKWCS) data provides information on diet, health and lifestyle. This database is stored electronically by the University of Leeds in restricted access files. The new research database proposed (UKWCS-HES) will have the current UKWCS data linked with information from Hospital Episode Statistics (HES) and the Office of Data Release (ODR) from Public Health England. No new data will be supplied by NHS Digital to the University of Leeds under this Data Sharing Agreement. A long period of data is required as the study is monitoring impact of wider health conditions that may take many years to manifest. The major health conditions are likely to become visible at least 10 years after the certain dietary and lifestyle is practised. The analysis needs to take account of morbidities prior to the start of the study. Individuals who had prior morbidities [e.g. heart defect, cancer, etc.] may be more/less likely to exhibit certain behaviours/contract certain health conditions of relevance to the study. From 1996 to 2017, the University of Leeds shared identifying details for the UKWCS participants with the relevant data providers including the Office of Population Censuses and Surveys (OPCS), the Office for National Statistics (ONS) and latterly NHS Digital. The relevant organisations provided information on participants’ demographics, cancer registrations and mortality records where applicable. In 2019, NHS Digital provided linked Hospital Episode Statistics (HES) data. Due to the potentially wide variety of possible harms which might be attributed to the varied health outcomes in the UK women, the study requires wide ranging hospital episode data not restricted to specific types of episode. The date of birth/incidence/death will generally be used in the analysis to derive age at episodes. The NHS Digital data has been linked with information collected from UKWCS participants via questionnaires and with National Cancer Registration and Analysis Services (NCRAS) collected from the Public Health England’s Office of Data Release (ODR). DATA FLOW All data is presently stored electronically by the University of Leeds’ Integrated Research Centre (IRC), but the University of Leeds' now request to store data on their new cloud platform, LASER, which is supported by Microsoft Azure. Microsoft Limited supply Cloud Services for the University of Leeds and are therefore listed as a data processor. They supply support to the system, but do not access data. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. The process for data merging and dissemination will have 2 steps. This Agreement permits the flow of data from the IRC to LASER, following the successful migration of data to LASER an amendment will be submitted to remove redundant storage locations, and evidence of data destruction at these locations will be provided. • Step 1: Create new merged database in secure Virtual Research Environment (VRE) then strip identifiable variables to create a pseudonymised data set. 1: Reuse within the University of Leeds • Step 2: Pseudonymised data set made available to other researchers in safeguarded area of Consumer Data Research Centre (CDRC). In order to facilitate access for a specific project, the IRC platform provides a secure Virtual Research Environment (VRE) for each research project and user access is limited to only authorised individuals for the approved purpose. STEP 1 Create new merged database and pseudonymous data subset Project-specific datasets are pseudonymised with all directly identifying details removed and replaced with a unique patient identifier. An encrypted participant list which holds ID number, date of birth and NHS number will be created and securely transferred to NHS Digital so cohort participants' records can be extracted. The University of Leeds Integrated Research Campus (IRC) will receive and store data through a secure file transfer of data from the UKWCS database linked with data from both Hospital Episode Statistics (HES) and Civil registration data from NHS Digital and the National Cancer Registration and Analysis Services (NCRAS) from Public Health England. This linked data will form the basis of the new research database (UKWCS-HES). Project-specific datasets are bespoke subsets which are minimised according to necessity for the approved purpose. The location of access is restricted. The IRC Data Services Team carry out disclosure control checks using relevant [21 words unchanged] that no inappropriate data is removed from the Virtual Research Environment (VRE). All direct identifiers will be removed, apart from ID number prior to use by researchers. All outputs are independently reviewed by the IRC Data Services Team prior [65 words unchanged] outputs are reviewed in line with the NHS Digital Disclosure Control Guidance e.g - e.g. HES analysis guide and any other legislation or agreements that apply to the particular project or dataset. Once step 1 is complete, the pseudonymised database will 2: Derived data to be deposited in accessed via the Consumer Data Research Centre (CDRC) to facilitate research requests and analysis. Step 2 - Requests received for access to pseudonymous data set which are when approved made available to the researcher. the researcher will be either a substantive employee of University of Leeds or will have an honorary contract with University of Leeds. The University of Leeds will produce a pseudonymised dataset containing variables derived from NHS Digital data but containing no NHS Digital data and will deposit this within the Consumer Data Research Centre (CDRC) to facilitate research requests and analysis by external researchers. The Senior Management Team (SMT) will assess whether the data access request fits the Centre’s remit. UKWCS team is notified that an application for their data has been received. The derived data held by CDRC has been proposed to be made available under the ‘Safeguarded’ tier, meaning successful applicants will be allowed to download the data directly. Further information can be accessed at https://data.cdrc.ac.uk/using-our-data-services. If acceptable the application will then be examined by the CDRC Research Approval Group (RAG). Data may be linked to other publicly available data which would not increase the risk of re identification. The University of Leeds has appropriate operational arrangements for making sure linkage to the public available data will not increase the risk of re-identification. Risk assessments are conducted to identify risks to information assets in the IRC and classify these by probability and likely impact of occurrence. A risk assessment defines any risk mitigating actions that can be taken to prevent the occurrence or reduce the impact of risk. A treatment plan is then designed in order to manage and contain risk, or a risk owner is assigned, to complete the risk assessment. The RAG consists of the chair member, ESRC and CDRC representatives, plus a member of the UKWCS team . A member of the CDRC RAG will then be selected as the Contact Researcher for each project and named on the application feedback letter. Any data shared with researchers via the CDRC must be subject to the conditions that the users: The Contact Researcher will inform the applicant of the decision in writing. Approval from the committee is “in principle”, subject to the applicant signing and returning the CDRC User’s Agreement Form. The Contact Researcher will be the point of contact for the duration of the project. Further use of the data outside those specifically stated in the application form for other areas of interest will require a new application being submitted and approval by the CDRC Research Approval Group (RAG). The researcher will be required to list the variables they are interested in. The RAG will ensure the data requested is adequate, relevant and limited to what is necessary in relation to the purposes for which they have been requested in line with GDPR necessity tests. i. must not combine it with other datasets which could potentially increase the risk of reidentification for individuals in the dataset; RAG would assess whether the request fits with the purposes set out in this agreement. Leeds University ensure that the data accessed by each project outlined in the application has met the necessity test with regards to GDPR requirements. ii. must not attempt to re-identify individuals in the dataset; University of Leeds staff, students and visitors would be able to apply for the data for research. If a researcher is not already a substantive employee of the University of Leeds then an honorary contract with visiting status would be set up containing the following text: iii. must not onwardly share the dataset; The University of Leeds will inform [your substantive employer] of any incident related to unauthorised disclosure or breach of confidence. [The substantive employer] retains responsibility for your conduct in connection with your work, including in particular your compliance with the terms of the honorary contract, as if your work or activities were performed for [the substantive employer]. Accordingly, [the substantive employer] agrees to take all appropriate disciplinary action promptly if any condition within this Agreement is breached by you. iv. must use the dataset for a defined purpose in support of the UKWCS’s aims defined within this Agreement, and (The agreement will be signed by the individual, the substantive employer, and the University of Leeds. This will ensure that the individual will be subject to the disciplinary process of their substantive organisation if he/she does something amiss with the data .) For all honorary contracts that the University of Leeds remains the Data Controller. v. must not publish the data. Any data processing within the study purpose by the applicant will use the pseudonymised database deposited in the Consumer Data Research Centre (CDRC) by the IRC Data Services Team. This will be through the use of a unique identifier assigned to each patient in the database instead of personal details such as name or NHS number; in line with the section 251 approval (without consent) through the Confidentiality Advisory Group (CAG) of the Health Research Authority. Under the terms of this Agreement, the University of Leeds is responsible for ensuring compliance with the above conditions and for confirming destruction of the data and/or cessation of access as appropriate once the data is no longer required for the purpose for which access was granted. Data may be linked to other publicly available data which would not increase the risk of re identification. Leeds university has appropriate operational arrangements for making sure linkage to the public available data will not increase the risk of re-identification. Risk assessments are conducted to identify risks to information assets in the IRC and classify these by probability and likely impact of occurrence. A risk assessment defines any risk mitigating actions that can be taken to prevent the occurrence or reduce the impact of risk. A treatment plan is then designed in order to manage and contain risk, or a risk owner is assigned, to complete the risk assessment. All requests to access the dataset in the CDRC are reviewed by the University of Leeds’ Senior Management Team (SMT). Access may only granted with the approval of the SMT. Any individuals granted access must sign a User Agreement which will set out the purpose and conditions for which the data may be used. 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). 3. Derived data to be accessed by a researcher from the University of Oxford The University of Leeds will supply a subset of UKWCS to a researcher at the University of Oxford. The dataset will conform to the specification to be shared with the CDRC and therefore contains no NHS Digital data and contains variables derived from NHS Digital’s data. Access will be granted subject to the same contractual controls applied for data access via the CRDC and subject to the same security and technical controls applied for data access for University of Leeds personnel.

Expected output

The researchers who use these data will be producing (on an ongoing basis) research publications in peer-reviewed journals structured along the lines of a scientific paper (e.g. Summary, Background, Methods, Results and Discussion) eg. BMJ, Lancet, Nature, British journal of Nutrition, and Public Health Nutrition Journal. Interim tables of results (aggregated data with small number suppression in line with the HES analysis guide) may be circulated as interim results for discussion and appended to the study report at the end of the project. Further outputs include presentations in scientific conferences; such as Nutrition Society Summer Conference, Society for Social Medicine, etc. Leeds University appreciate the time taken for publications to appear and so anticipate the timing for this activity within one or two years after the data has been analysed. The UKWCS database has been extensively used by researchers to undertake population-based health research studies. There have been nearly 100 peer reviewed publications utilising the UKWCS database since its establishment in 1995. Findings are also shared through extensive public engagement activities including regular Scientific events and lectures to general public and health groups. After receiving the data linkage, UKWCS team will focus on optimising the database within 1 month after receiving the data and the database will be available for researchers to access by then. A list of publications resulting from the analysis is available on https://ukwcs.leeds.ac.uk/publications/. Researches at the University of Leeds can access pseudonymised, non-sensitive record level database or delivery of aggregated tables; presentations, spreadsheets, word documents and other formal documentation for generation of research publications in peer-reviewed journals; and conference posters or presentations in scientific conferences. Information to be included in health assessments, nutrition and lifestyle epidemiology, natural history of disease, health economics and outcomes research. As an example output from the UKWCS, the University of Leeds reported on diet and age at natural menopause in the Journal of Epidemiology and Community Health in 2018. This generated a lot of interest being one of the first papers discussing this topic and was picked up by 165 news outlets. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide Another output demonstrated that fidgeting has been shown to reduce the risk of all-cause mortality associated with excessive sitting time in the Cohort. A peer-reviewed article 'Sitting Time, Fidgeting, and All-Cause Mortality in the UK Women’s Cohort Study' was published in the American Journal of Preventive Medicine in 2017. This work was featured in a programme on the topic broadcast on BBC Radio 4. The expected outputs from individual projects/analyses using the data are research publications in peer-reviewed journals structured along the lines of a scientific paper (e.g. Summary, Background, Methods, Results and Discussion). The journals in which these would be published are likely to include the BMJ, Lancet, Nature, British journal of Nutrition, and Public Health Nutrition Journal. The publications will typically be within one or two years after the data has been analysed. Interim tables of results (aggregated data with small number suppression in line with the HES analysis guide) may be circulated as interim results for discussion and appended to the study report at the end of the project. Further outputs are likely to include presentations in scientific conferences such as Nutrition Society Summer Conference, Society for Social Medicine, etc. and conference posters or presentations in scientific conferences. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

Expected measurable benefits

The researchers at university of Leeds will be using the linked data to produce (on an ongoing basis) research publications in peer-reviewed journals and presentations in scientific conferences. The data will be used to undertake independent research into disease management and outcomes to improve patient care, health economic studies and epidemiology of diseases with regards to dietary and lifestyle exposure. The following are examples of expected benefits from specific projects using the UKWCS: The previous UKWCS database is extensively used by researchers to undertake population-based health research studies. There have been nearly 100 peer reviewed publications utilising the UKWCS database since its establishment in 1995. Findings are also shared through extensive public engagement activities including regular Scientific events and lectures to general public and health groups. The UKWCS is one of the longest running of the British women's cohort studies. Today, the UKWCS offers a unique opportunity to explore the long-term biological and social processes of ageing and cause of death. Evidence is growing from this cohort study and others, that factors from later life (such as adult smoking, diet, exercise and socioeconomic circumstances) affect the opportunity to age well. This is of interest to policymakers, practitioners, and older people themselves. As the study is nationally representative, it will also provide valuable information regarding the factors associated with health care utilisation of the middle-age of women population. The linked data set will be used to undertake independent research into disease management and outcomes to improve patient care, health economic studies, nutrition and health epidemiology studies. It anticipates adding to the knowledge to improvements in preventing chronic disease and maintaining good health in middle-aged women. Prevention depends on understanding of causes. The UKWCS can help provide a better understanding of mechanisms underlying disease and health; how these are influenced by the environment and what the potential population impact might be. There is increasing evidence for common pathophysiological pathways including glucose metabolism, inflammation, and hormonal profile for ageing related conditions. In addition to chronic disease and cancers, there need to be a better understanding of outcomes relevant to older populations such as functional health and quality of life. The UKWCS is a large long term prospective study that allows this approach. In particular, through knowledge transfer, public engagement, publications, presentations and invited commentaries (https://ukwcs.leeds.ac.uk/) the UKWCS has contributed to a body of evidence to influence policies and support evidence based medicine. The example projects provided above have anticipated benefits including: [1 paragraph unchanged] This research will lead to a better understanding of the risks associated with different dietary behaviours and future risk of dementia and Alzheimer’s Disease. It therefore has the potential to impact on public health policy. UKWCS will use HES data to examine which dietary factors influence incidence of Alzheimer’s Disease (AD) or dementia. HES records will be used to identify cases of AD or dementia. Specific dietary factors will be the focus: high fat/meat intakes or Mediterranean/vegetarian dietary pattern. This research will lead to a better understanding of the risks associated with different dietary behaviours and future risk of dementia and Alzheimer’s Disease. It therefore has the potential to impact on public health policy, potentially reducing rates of dementia through improved dietary behaviours. [1 paragraph unchanged] Physical activity is associated with and sedentary behaviour will be explored in relation to risk of cancer, however, the cancer incidence. The interplay between diet and physical activity in relation to BMI and other cancer risks is unclear. Physical activity and sedentary behaviour will be explored in relation to risk of cancer incidence. HES data will be used to provide information on cancer incidence. The UKWCS has previously shown that fidgeting in sedentary women is protective against all cause mortality. HES data will be used to provide information on cancer incidence. This new analysis will lead to a better understanding of physical activity [8 words unchanged] It therefore has the potential to have an impact on public health policy. policy that could lead to awareness campaigns to advise the public on the need for physical activity of different types as a means to reduce risk of cancer. [1 paragraph unchanged] Whilst it is known that some cancers are associated with BMI, it [70 words unchanged] BMI is not available since individuals do know what size clothes they buy. buy supporting simple risk scores for patients enabling more targeted advice to reduce risk. [1 paragraph unchanged] Whilst it is known that breast feeding has many benefits for both [8 words unchanged] later risk of breast or other female reproductive hormone cancers is unknown. Breast feeding duration and frequency will be explored as a protective factor for breast cancer incidence. Analysis will make use of PHE hormone receptor status data and HES data for breast cancer risk. This work has potential to influence public health policy promoting breast feeding. feeding which in turn could reduce risk of longer term chronic disease if associations are found. [1 paragraph unchanged] Middle-class people generally have healthier diets than lower-class people. There are known links between socioeconomic status and the healthiness of individual’s diets. Dietary mediators seem to play an important role in the pathogenesis of cardiovascular disease, mediating some of the discrepancies in atherosclerosis among different socioeconomic layers. The impact of diet in relation to different social groups on risk of heart disease will be explored. Careful consideration of confounding factors will be required and analysis will be stratified according to social group. HES data will provide information on diagnosis of coronary heart disease, myocardial infarction and stroke. Further understanding of these relationships will help to drive public policy and strategies for reducing inequalities across the social classes. classes, potentially reducing risk of disease and improving health care for different socio-economic groups. [1 paragraph unchanged] High blood pressure (HBP or hypertension) is the second leading cause of [14 words unchanged] to narrow, weaken or harden. Some dietary behaviours may increase blood pressure (eg. (e.g. high salt) whereas other dietary patterns (eg. (e.g. DASH diet) may support blood pressure reduction. Understanding of how diet may influence blood pressure and kidney disease will provide benefit the public through provision of more evidence to help develop prevention and treatment strategies with clear public benefit. strategies. [1 paragraph unchanged] Several studies indicate that parity and lactation are associated with modest, short-term [15 words unchanged] provide further evidence to the limited data available on this topic worldwide. HES data will provide hip fracture incidence data. Any associated effect with oral contraceptive use could influence policy around prescribing to affect risk of hip fracture in women, potentially preventing associated morbidity and reducing healthcare costs.

Benefits reported

Below are some of the latest publications produced from the UK Women’s Cohort Study (UKWCS): The use of the UKWCS-HES database has allowed researchers to gain a better understanding of the relationship between diet and health. The results listed below may have the potential to impact on public health policy. Dunneram Y; Greenwood DC; Burley VJ; Cade JE (2018) Dietary intake and age at natural menopause: results from the UK Women’s Cohort Study. Journal of epidemiology and community health, - It has been shown that a high consumption of processed meat and total meat was associated with an increased risk of breast and endometrial cancer. High intake of tomatoes (HR 0·87, 99 % CI 0·75, 1·00) and dried fruits (HR 0·60, 99 % CI 0·37, 0·97) was associated with a reduced risk of breast and endometrial cancer, respectively. Lambert JD, VanDusen SR, Cockcroft JE, Smith E, Greenwood DC, Cade JE: Bitter taste sensitivity, food intake, and risk of malignant cancer in the UK Women’s Cohort Study. European Journal of Nutrition. - Researchers using the UKWCS-HES database found that recommended sleep duration is associated with higher consumption of fruits and vegetables. Pandeya N; Huxley RR; Chung H-F; Dobson AJ; Kuh D; Hardy R; Cade JE; Greenwood DC; Giles GG; Bruinsma F (2018) Female reproductive history and risk of type 2 diabetes: A prospective analysis of 126 721 women. Diabetes, obesity & metabolism, - There was found to be an inverse association for risk of breast cancer with total fibre and cereal fibre intake has been demonstrated in premenopausal, but not postmenopausal women. Rada-Fernandez de Jauregui D; Evans CEL; Jones P; Greenwood DC; Hancock N; Cade JE (2018) Common dietary patterns and risk of cancers of the colon and rectum: Analysis from the United Kingdom Women’s Cohort Study (UKWCS). International Journal of Cancer, - In postmenopausal women, a positive association was found to exist between weight status and risk of breast cancer incidence. Zhu D; Chung HF; Pandeya N; Dobson AJ; Kuh D; Crawford SL; Gold EB; Avis NE; Giles GG; Bruinsma F (2018) Body mass index and age at natural menopause: an international pooled analysis of 11 prospective studies. European Journal of Epidemiology, , pp. 1-12 - There was a possible protective association for cereal sources of fibre on fatal stroke risk in overweight women. Total fibre intake was associated with total (fatal plus non-fatal) stroke events. Jones P; Cade JE; Evans CEL; Hancock N; Greenwood DC (2018) Does adherence to the World Cancer Research Fund/American Institute of Cancer Research cancer prevention guidelines reduce risk of colorectal cancer in the UK Women’s Cohort Study?. British Journal of Nutrition, 119 (3), pp. 340-348 - High-dose vitamin C intake was linked to healthier behaviours and a history of breast cancer, total cancer and other illnesses within close family members. Other publications and proceedings are available at https://ukwcs.leeds.ac.uk/publications/ - A healthier diet has been shown to be more expensive than less healthy choices. The healthiest diet was twice the price of the least healthy.