Cohort Descriptives

Variable Response
Cohort name The Million Women Study
Cohort acronym Million Women
General Study Overview The Million Women Study is a national study of women’s health, involving more than one million UK women aged 50 and over. It is a collaborative project between Cancer Research UK and the National Health Service, with additional funding from the Medical Research Council and the Health and Safety Executive, which aims to answer many outstanding questions about the factors affecting women’s health in this age group. The main focus of the study relates to the effects of hormone replacement therapy use, but the large size of the study means that a very broad range of health issues can be addressed.
The Million Women Study is investigating how various reproductive and lifestyle factors affect women’s health. In particular, the study is looking at how hormone replacement therapy affects a woman’s breasts and other aspects of her health. Other factors being investigated include diet, exercise, employment patterns, oral contraceptive use, childbirth and breastfeeding, and family history of illness, in relation to a wide range of cancers and to other conditions such as fractures, gallbladder problems and cardiovascular disease.
Number of subjects at baseline 1,300,000 (and 55,000 in the disease susceptibility study, started in 2006)
Institution name The University of Oxford
Department name Cancer Epidemiology Unit
City Oxford
Study or database website

http://www.millionwomenstudy.org/

Principal Investigator (PI): Name Prof Dame Valerie Beral
PI: Address The Million Women Study Co-ordinating Centre, Cancer Epidemiology Unit, Richard Doll Building, Roosevelt Drive, Oxford, OX3 7LF, United Kingdom
PI: email

valerie.beral@ceu.ox.ac.uk

PI: phone +44 (0)1865 289600
Administrative Contact (AC): Name Jane Green
AC: Address The Million Women Study Co-ordinating Centre, Cancer Epidemiology Unit, Richard Doll Building, Roosevelt Drive, Oxford, OX3 7LF, United Kingdom
AC: email Jane.green@ceu.ox.ac.uk
AC: phone 01865 289659
Technical Contact/Data manager (TC): Name Anna Brown
TC: Address The Million Women Study Co-ordinating Centre, Cancer Epidemiology Unit, Richard Doll Building, Roosevelt Drive, Oxford, OX3 7LF, United Kingdom
TC: email

anna.brown@ceu.ox.ac.uk

Key study references

Open literature list

Population based study? Yes
Family based study? No
Clinical based sample? No
Is there follow-up data available? Yes
Were participants included prior to development of dementia (may refer to controls only)? Yes
Were participants included prior to development of MCI (may refer to controls only)? Yes
How is data collected? Combination
Who carries out data collection? Participants report on postal questionnaires and follow ups are done via data linkage.
Does this take place in participants' homes or at a central location? Home
Do participants take part individually or are families/partners involved? Individually
Dementia cases ascertained as part of study: No
Diagnosis based on review of existing clinical data No
Was diagnosis/primary outcomes made blind to exposure variables? No
How many times followed up? 5
Study start date 1996-01-01
Is study ongoing? Yes
Is study still recruiting? No
Inclusion criteria All screening centres in the NHS Breast Screening Programme (women in the age range 50-64 at recruitment) were eligible to collaborate in this research and all women invited for screening were eligible to take part.
Exclusion criteria Women who did not attend their breast screening appointment.

Demographic and Clinical Information

Variable Response
Demographics
Age Yes
Age at time of diagnosis of dementia Yes
Age at last follow-up Yes
Age at time of death Yes
Sex Yes
Ethnicity Yes
Education Yes
Physical examinations
Any physical examination performed? Yes
Blood pressure Data available
Assessed before onset of dementia
Comments: For a subset of 3,500 women
Weight Data available
Assessed before onset of dementia
Height Data available
Assessed before onset of dementia
Anthropometry Data available
Assessed before onset of dementia
Comments: For a subset of 3,500 women
Medical conditions
Cardiovascular disease data Yes
Medication use for CVD Data available
Hypertension Data available
Systolic/diastolic BP Data available
Hypotension Data available
Hypercholesterolemia Yes
Virus testing No data available
Olfactory sensitivity No
Medication use Yes: Some medications known.
Cancer Data available
Diabetic Status Data available

Cognitive Outcomes

Variable Response
Any domain-specific cognitive test performed? No
IQ data available? No
Cognitive background? Yes
Years of education Yes
Level of education Yes
Parental education No
Standard dementia global cognition scales? No
MMSE No
MoCA No
ADAS-Cog No
Addenbrooke's Cognitive Exam No
3MS No
GPCOG No
Other assessments of global cognition Self-rating memory (excellent, good, fair or poor).

Non-Cognitive Clinical Outcomes

Variable Response
Dementia diagnosis
Alzheimer's dementia Yes
Lewy Body Disease Yes
Huntingtons Disease Yes
Parkinsons Disease Yes
Frontotemporal dementia Yes
Vascular dementia Yes
MCI No
Subjective complaint No
Dementia diagnosis (Other comments) No
Functional rating scales
Any information on dementia rating collected? No
PDQ39 (PD specific) No
UPDRS (PD specific) No
Hoehn and Yahr (PD specific) No
Schwab and England (PD specific) No
UHDRS (HD specific) No
Any information on subjective complaints collected? No
Any neuropsychiatric rating scale administered? No
Hospital anxiety depression scale/psychiatry (HADS) No
Specify any other scales No
Any Quality of Life Data Colllected? Yes
Quality of Life-Alzheimers Disease (QOL-AD) No
Dementia Quality of Life Instrument (DEMQOL) No
Discomfort Scale for Dementia of Alzheimers Type (DS-DAT) No
Progressive Deterioration Scale (PDS) No
Quality of Life in Late-Stage Dementia Scale (QUALID) No
Bedfords Alzheimers Nursing Severity Scale(BANS-S) No
EQ-5DVAS No
Short Form (SF) 36 No
Health Utilities Index 1, 2 or 3 No
Specify any other quality of life scales Asked about social contact and major life events, namely a recent divorce, death of a spouse or close family member. Questionnaires also include self rated health and fitness, difficulty in bathing, dressing.
Any information on Caregivers and Caregiving Collected? Yes
Caregivers for Alzheimers disease Problems Scale (CAPS) No
Community Dementia Quality of Life Profile (CDQLP) No
COQoL-AD No
Dementia Management Strategies Scale (DMSS) No
Caregiver Activity Survey (CAS) No
Quality of life of caregivers (CQOL) No
Screen for Caregiver Burden/Time Spent Caregiving (TSC) No
Work Productivity and Activity Impairment Questionnaire-dyad version (WPAI-DYAD) No
Zairit Burden No
Health service utilisation
Any Health Resource Utilisation Collected ? Yes
Hospital utilisation Yes
Prescription Medicine Cost No
Over the Counter Drug Costs No
Nursing Home Costs No
Costs of Visits to Specialists (out-patient) No
Costs of Home-Care No
Admission to nursing home No
Admission to home care No
Day care at nursing home No
Day care at home for elderly No
Home care- domestic No
Home care- personal care No
Home care- nursing No
Physical therapist No
Care of community mental health team No
Permanent stay at nursing home No
Informal ADL care No
Informal iADL care No
Days of work absence if having a paid job No
Other neurological or psychiatric measurements? Yes
Any stroke data? Yes
Stroke type Yes
Transient Ischemic Attack No
Carotid plaques No
Any head trauma data? Yes
Loss of consciousness No
Sports, soccer and boxing No
Head trauma severity No
BISQ or equivalent No
EEG No
Psychiatric evaluations Yes
CESD scale (depression) No
Personality evaluation No
Apathy evaluation No
Anxiety measure Yes
Resilience evaluation No

Imaging

Variable Response
Structural T1 Not acquired
Not acquired
Fluid attenuation inversion recovery (FLAIR) Not acquired
Not acquired
Diffusion imaging (DTI/DWI) Not acquired
Not acquired
f-MRI (task) Not acquired
Not acquired
f-MRI (rest) Not acquired
Not acquired
PET Not acquired
Not acquired
SPECT Not acquired
Not acquired
MEG Not acquired
Not acquired
In vivo Spectroscopy Not acquired
Not acquired
Do you use an imaging data management system (e.g. XNAT or LORIS)? No

Genetics

Variable Response
Overview
N Whole genome sequenced No
Gene screening
APOE No
TREM2 No
APP No
PSEN1 No
PSEN2 No
GRN No
MAPT No
C9ORF72 No
VCP No
CHMP2B No
TDP-43 No
PRNP No
SNCA No
LRRK2 No
PINK1 No
PARK2 No
PARK7 No
NOTCH3 No
CST3 No
TTR No
GSN No
ITM2B No
HTT No
NPC1 No
NPC2 No

Biological samples

Variable Response
Blood collected Yes
Plasma Yes
Comments: N= 51,000
Serum No
RNA No
DNA Yes
Comments: N= 25,000 extracted DNA
Abeta 1-40 No
Abeta 1-42 No
Abeta x-40 No
Abeta x-42 No
Blood Metabolic Analytes
CRP (c-reactive protein) No
eGFR (estimated Glomular Filtration Rate) No
Glucose No
HbA1c No
Lipids Yes
Comments: N = 20,000
Liver Function Tests No
Serum creatinine No
Homocysteine No
Folate No
Other blood samples No
Are laboratory protocols and storage information available for bloods Yes
Urine collection
Urine No
Autopsy data
Autopsy No
Measurements already performed No
Saliva
Saliva collected No
Cortisol No
Are laboratory protocols and saliva storage information available? No
CSF
CSF collected No
Are CSF laboratory protocols and storage information available? No
mtDNA abnormalities No
Oxidative stress No

Brain donation

Variable Response
Is brain donation part of the existing protocol? No
Are information sheets made available to representative or consultees? No
Are retrospective interviews carried out after the participant's death? No
Is there a procedure for declining donation/failed recruitment/project termination? No
Has an actuarial analysis been completed? No

Lifestyle

Variable Response
Smoking Yes
Passive smoking Data available
Current smoking Data available
Former smoking Data available
Alcohol Data available
Units per day/week vs weekend Data available
Specified beverage type (wine, spirits, beers) Data available
Abstainers/former users Data available
Drugs of abuse assessment
Obesity and associated risk factors
BMI Data available
Comments: Self report for cohort, measured for subset
Hip/waist circumference Data available
Comments: Self report for cohort, measured for subset
Blood lipids Data available
Comments: N=20,000
Type of exercise: heavy, light Data available
Exercise duration Data available
Other measurements of activity Self report activity and questions pertaining to job.
Diet Yes
Carbs, protein, fats, fish oil Data available
Vegetarian? Data available
Coffee and caffeine Data available
Vitamin A, B, E Data available
Fat intake MUFA, PUFA Data available
Food questionnaires Data available
Other dietary items Yes
Employment status
Employment status Data available
Living situation
Living situation Data available
Socioeconomic status
Socioeconomic status measures Data available
Sleep assessment
Questionnaires Data available
Other sleep recording (specify) Participants are asked about napping and time spent sleeping in the questionnaires.

Ethics and Engagement

Variable Response
Participant engagement
Is there participant representation in the governance of the cohort? No
Do existing mechanisms for consulting/involving participants exist? No
If so, does this happen on an ongoing or an ad hoc basis? NA
Ethics
Is there an ethics advisory or ELSI group within the cohort governance? There is a lay member on the Million Women advisory committee
Does the cohort include participants who lack capacity? No
Is there a process in place for participants who lose capacity? No
Do participants provide contact information for a person to act as a potential consultee? No
Disclosure
Do procedures exist for the disclosure of incidental findings? No
What kinds of finding do these relate to? (imaging, genotyping, etc) The only individual level 'incidental findings' are the results of genetic/biochemical blood tests. The MW policy is not to send such results to participants or their GPs, as the tests are done for research and not clinical diagnosis. Participants consent to the study on this basis.
Who is responsible for disclosing incidental findings? NA
Do procedures exist for the disclosure of clinically relevant information identified as a direct focus of the study? (e.g. a diagnosis of dementia) No
Recruitment
How was the cohort recruited (NHS or not, primary or secondary care)? Through the NHS breast screening programme.
Does the study involve ongoing connections with participants' own doctors (e.g. GPs)? Yes
Consent and recontact
Is there consent for recontact? Yes

Data Management

Variable Response
Consent for linkage to routine data
Which parts of the UK are represented by participants in your cohort? England
England
Scotland