Title of the cohort

Million Women Study

Acronym for cohort

MWS

Name of Principal Investigator
Title Professor
First name  Valerie
Last name Beral
Address of institution where award is held
Institution Cancer Epidemiology Unit, University of Oxford
Street Address Richard Doll Building, Roosevelt Drive
City Oxford
Postcode OX3 7LF
Country

United Kingdom

Website

www.millionwomenstudy.org

Contact email
Funding source

Cancer Research UK
Medical Research Council
Health and Safety Executive

1. The cohort includes, or expects to include, incidence of the following conditions
  • Alzheimer’s disease and other dementias
  • Motor neurone diseases
  • Parkinson’s disease
When studies on the above condition(s) are expected to become possible

2011 – 2015

2a. Stated aim of the cohort

To study hormonal, reproductive and other factors affecting women’s health from middle age onwards

2b. Features distinguishing this cohort from other population cohorts

Large size Complete follow-up through linkage to NHS records for deaths, cancer registrations and hospital admissions Detailed demographic and lifestyle information Blood samples available for several thousand women

3a. i) Number of publications that involve use of cohort to date

58

3a. ii) Up to three examples of studies to date (PI, Institution, Title of Study)
3b. Publication list/link to where data or publications are accessible (if available)

Study website

3c. Information (i.e. research findings) expected to be gained from the population cohort
4a. Study criteria: age range of participants at recruitment
Age in years from: 50-64
To (‘until death’ if applicable): until death
4b. Study criteria: inclusion criteria

All women invited for NHS breast screening appointment during recruitment phase were invited to take part; those who attended screening and completed the study questionnaire were included

4c. Study criteria: exclusion criteria

see above

5. Size of the cohort (i.e. number of participants enrolled)

More than 15,000

6a. Measures used to characterise participants

Very wide range: details on website

Age at recruitment and date of birth
Region
Townsend deprivation index
Smoking, alcohol
Medication
Height, weight, waist, hip;derived BMI
Physical activity
Diet
Reproductive factors including detailed use of hormone replacment therapy
Medical history Family history
Genetic factors for subset of cohort

6b. Additional measures for participants with a clinical disorder

No

6c. Are there defined primary and secondary endpoints (e.g. defined health parameters)

Breast cancer incidence and mortality were the primary endpoints for the study, but other cancer and non-cancer endpoints have always been included

7. Study design

Prospective cohort

8. Cases matched by
  • Other health assessment (specify) / N/A
  • not matched
9a. Does the study include a specialised subset of control participants

No

9b. If yes, description of specialised subset of control participants
10a. i) Data collection start date

01-01-1996

10a. ii) Data collection end date
10a iii) Data collection for this study is
  • Data collection ongoing
  • Data analysis ongoing
  • Closed to new patients
10b. Plans to continue the cohort study beyond the current projected end date
  • Yes – intend to apply for funding
11. Data collected
  • Through links to medical records
12. System in place to enable re-contact with patients for future studies

Yes (participants have given permission to be re-contacted via the PIs to ask if they would participate in further studies)

13a. Format and availability of data stored in a database
Yes/No % available
Data summarised in database  yes
Database is web-based
Database on spreadsheet
Database is on paper
Other (specify)
Language used:
13b. Format and availability of data held as individual records
Yes/No % available
Data held as individual records  Yes
Data is web-based
Data held on computer based records  Yes
Data held on cards
Other (specify)
Language used:
14a. Are data available to other groups

Yes

14b. Access policy/mechanisms for access if data are available to other groups
  • Apply to PI or co-ordinator at resource
  • Access through collaboration with PI only
15. Data sharing policy specified as a condition of use

Data made publicly available after a specified time point

16a. Are tissues/samples/DNA available to other groups

Yes

16b. i) Description of available tissues/samples/DNA
  • Living donors:blood
16b. ii) Form available tissues/samples/DNA are supplied in
  • Secondary samples: derivatives of primary samples
16b. iii) Is the access policy/mechanism for obtaining samples the same as that for obtaining data

Yes

17. Is information on biological characteristics available to other groups
  • No

    Principal Investigators

    Professor Dame V Beral

    Institution

    University of Oxford

    Contact information of lead PI

    Country

    United Kingdom

    Title of project or programme

    Million Women Study

    Source of funding information

    MRC

    Total sum awarded (Euro)

    € 6,015,017

    Start date of award

    01/10/2013

    Total duration of award in years

    5.0

    The project/programme is most relevant to:

    Alzheimer's disease and other dementias | Neurodegenerative disease in general

    Keywords

    cohort| dementia| eHealth| fracture| heart disease| NHS linkage| osteoporosis| risk factor| stroke| women

    Research Abstract

    In 1996-2001 we recruited a cohort of 1.3 million women, a quarter of the female UK population then aged 50-64 years. About 99% have been followed for more than 10 years for hospital admissions and deaths. Mean age is now 70 years and conditions associated with ageing, such as dementia and osteoporosis, are becoming increasingly common. We plan to focus on these emerging health problems, following the cohort for a further 5 years by electronic linkage to NHS records. The increasing availability of electronic routinely collected NHS records has revolutionized questions that can be addressed in cohort studies. Only recently was it possible to obtain linked NHS records for cause-specific hospital admissions in England. Linkage to NHS primary care prescription and diagnostic data has just become available. For women with a primary care or hospital record of dementia, we will confirm diagnoses and classify them by phenotype, where possible. We will then examine associations with postulated risk factors, taking care to avoid ‘reverse causation bias’ by focusing on the 15,000 women first diagnosed with dementia 10+ years after reporting risk factors. Bisphosphonates are increasingly used for osteoporosis, but surprisingly little robust information exists about their safety. Recent reports of serious pathological lesions of the bone and other possible long-term side effects are stimulating debate about the balance between beneficial and adverse effects in users. Randomized trials have been too small, with too little follow-up, to evaluate such effects. About 10% of study participants have used bisphosphonates, permitting reliable assessment of their net effect, overall and by duration of use. The uniqueness and timeliness of the research planned derives mainly from the size and maturity of the cohort, the wealth of prospectively collected personal data, and the virtually complete follow-up via electronic NHS records.

    Lay Summary

    The Million Women Study is the largest study of women’s health in the world. In 1996-2001, a quarter of UK females then aged 50-64 years (1.3 million women) joined the study. Study participants have provided details about their lifestyle and health and given signed consent for follow-up. Since then their health has been followed mainly through electronic linkage to routinely collected NHS records. The aim of the study is to provide reliable information on potentially modifiable causes of common and serious illnesses, to help improve individual and public health. The study is jointly funded by Cancer Research UK, mostly for studies of cancer, and the Medical Research Council, mostly for studies of other conditions. We have described links between smoking, alcohol, obesity, and use of hormone replacement therapy and women’s risk of developing various diseases, recently reporting that the harms of smoking and the benefits of stopping were greater in women than previously thought. This proposal is for research on dementia, osteoporosis, stroke and other severe disabling conditions that become increasingly common as women age. With this large study, detailed lifestyle information provided by women, and some 15 years follow-up through linkage to NHS medical records, we are uniquely placed to answer some major outstanding questions about what causes some of the serious conditions associated with ageing, and how they might be prevented. We have already been able to link the study cohort to NHS records on death, cancer incidence, and hospital admissions. In the next 5 years we will enhance the linkage with newly-available information on medications prescribed and on conditions diagnosed in general practice. Dementia is one of the most serious causes of disability as women age. There is surprisingly little good information about what people can do in middle-age to help prevent dementia occurring in later life. For example the effects of factors like smoking, alcohol, exercise and diet are still uncertain. Because dementia develops slowly over many years, and in the early stage can affect what people do, we need to study lifestyle factors over a long period before dementia is diagnosed. We will be able to follow large enough numbers of women for long enough to be able to provide reliable results, which other studies have not been able to do. With some 20,000 women in our study expected to develop dementia by 2017, we will also be able to study differences in risk factors for different types of dementia, such as Alzheimer’s disease and vascular dementia. Osteoporosis, where bones become weak and liable to fracture, is increasingly common as women age. Osteoporotic fractures of the hip and other bones are major causes of pain, disability and death. Bisphosphonate drugs, such as alendronate, are commonly prescribed to prevent fractures and their use is increasing rapidly. In recent years controversy about the balance between the benefits and risks of long-term use of these drugs has been ignited by reports of potentially serious side effects, which we plan to investigate. We will also examine whether lifestyle factors in middle age, including diet and exercise, help prevent fractures occurring as women grow older. This research will be made possible by combining the health information women have so generously given us with the excellent medical records available for the UK population through the NHS.

    Further information available at:

Types: Population Cohorts
Member States: United Kingdom
Diseases: Alzheimer's disease & other dementias, Motor neurone diseases, Parkinson's disease & PD-related disorders
Years: N/A
Database Categories: N/A
Database Tags: N/A

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