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PreFIT Patients

Edits 9th June 2022, (Approved by NHS Digital )

This page describes the Prevention of Falls Injury Trial (PreFIT) which finished in 2019. If you took part, this page describes how your personal data were used and are being stored. We refer to this as a "privacy notice" because it explains how we look after your personal data. The University of Warwick Clinical Trials Unit is referred to as the "Data Controller" which means that we have overall responsibility for looking after your data.

We start with a short reminder and overview of the PreFIT research study.

What is the problem?

As we get older, we are more likely to fall. One in three people aged 65 years and older fall at least once a year. These falls can cause fractures. Reducing falls and fractures is important for maintaining the health, wellbeing, and independence of older people.

UK guidance recommends that all people aged over 65 years who are at risk of falling should have a falls assessment with a healthcare professional. These assessments usually include an eye test, a review of prescriptions, an assessment of balance and checking for any trip hazards at home.

Why was PreFIT funded?

The NHS did not know whether these falls assessments, called fall prevention programmes, reduced fractures or improved quality of life. Some studies suggested that lower leg exercises might be better for older people. So, researchers from Warwick Clinical Trials Unit were funded by National Institute for Health Research to investigate how best to prevent falls and fractures (broken bones) in older people.

What did we do?

We tested three different fall prevention strategies for older people at higher risk of falling. A total of 9803 people, aged 70 to 101 years, from around England took part in PreFIT. We compared (tested) three strategies: i) an information booklet only, or an information booklet with ii) a strength and balance exercise programme lasting six months; or iii) a one-to-one falls assessment programme. We then counted the number of falls, number of fractures, and quality of life in everyone taking part over 18 months. We also worked out the costs of each strategy.

What did we find?

We found clear evidence that there was no benefit on reducing number of fractures or number of falls for our falls assessment or exercise interventions. In the short term, we found that people doing exercise had fewer falls and slightly better overall quality of life, but this did not last over 18 months.

Consent for access to my personal data

Everyone taking part in the PreFIT trial was asked to sign a Consent Form. As a reminder, you provided signed, written consent at the start of the study for your contact details to be held at Warwick Clinical Trials Unit. This was so the study team could send you questionnaires and other study-related documents. You also consented for the trial team to access your medical records and healthcare data. We accessed your health data via NHS Digital who look after health and care information.

Who is NHS Digital?

NHS Digital is an organisation that collects health and care data from NHS hospitals in England and Wales. Examples of the type of health data that they hold includes hospital admissions, operations, accident and emergency attendances and other health care data.

Why did you access my personal data from NHS Digital?

We wanted to know if you had been in hospital or had appointments related to any fractures over the 18 months of the study. We looked at your NHS data, to search for any fracture treatments or operations by screening all hospital attendances, outpatient appointments and admissions. We counted fractures for everyone taking part in PreFIT. This helped us to work out which of the three treatment strategies was the best and also gave us information about healthcare costs.

How did you access my data from NHS Digital?

We applied to NHS Digital for access to your health data. We provided NHS Digital with your NHS number, date of birth and postcode to link to the data held by NHS Digital. This linked data was then transferred back to the University of Warwick Clinical Trials Unit using a secure, encrypted procedure. Only a few selected, named members within the PreFIT study team ever had access to this data.

Who has access to my data?

The University of Warwick Clinical Trials Unit is referred to as the "Data Controller" which means that we have overall responsibility for looking after your data. The PreFIT team have now finished and have published the study results.

We still hold some personal data, with your consent. This includes your name, address, NHS number, date of birth and postcode.

We have deleted all the clinical information on number of hospital admissions, appointments and attendances from NHS Digital. These ‘original’ data are no longer held by the study team.

The team still hold some of your personal data but all healthcare data obtained from NHS Digital has been deleted.

We collected health data which is considered to be ‘special category personal data’.

When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research. Your information could be used for research in any aspect of health or care, and could be combined with information about you from other sources held by researchers, the NHS or government.

Where this information could identify you, the information will be held securely with strict arrangements about who can access the information. The information will only be used for the purpose of health and care research, or to contact you about future opportunities to participate in research. It will not be used to make decisions about future services available to you, such as insurance.

Where there is a risk that you can be identified your data will only be used in research that has been independently reviewed by an ethics committee.

Will my participation in the trial be kept confidential?

We would like to reassure you that all personal data has been handled as you would expect and has been kept strictly confidential at all times and in compliance with the UK GDPR.

Will my data be shared with anyone?

We will not share your data with any third party outside of the PreFIT study team. It was only shared with NHS Digital for the purposes of linking your health and care records. Information that could identify you by name was only used to post out documents to you.

We used a study number on all questionnaires so that your name and personal details did not appear anywhere other than on the restricted database held by the study team. Access to this database was restricted and password protected.

Can I opt out of the PreFIT Study?

It is not possible to opt out of the PreFIT study now it has been completed. The data have been reported in medical journals. All results were reported as ‘aggregate’ (summary) values and it is not possible to identify anyone who took part in the trial.

Please do not hesitate to contact us if you have any questions or queries about your participation in the trial. Please call 024 765 74656.

How long will my data be kept for?

Your data will be safely archived for at least 10 years beyond the end of the trial. This is a requirement of the University of Warwick Clinical Trials Unit which adheres to UK regulatory requirements for clinical trials.

What is the “legal basis” for you holding and processing my data?

Under the UK General Data Protection Regulation (UK GDPR), the lawful bases we rely on for processing your data are:

  • Article 6(1)(e) - processing is necessary for the performance of a task in the public interest and
  • Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes

This allows us to process your personal data. If you would like more information about the lawful basis for processing your data, please visit the Information Commission’s Office (ICO) website:

Please note that the study team do not undertake any automated decision-making or profiling, based on the trial data we hold.

What are my rights?

As an individual taking part in a research study, you have the right to query any issue in relation use of your personal data. In the first instance, you can contact our Data Protection Officer at the University of Warwick who can help resolve any query, concern or complaint you raise. Contact details can be found on the link below.

How can I lodge a complaint?

If you are concerned or unhappy with any aspect of your involvement in the PreFIT study, you have the right to lodge a complaint with the ICO.

You can register a complaint on the ICO website ( or you can ring the ICO helpline on 0303 123 1113 between Monday and Friday, 9am to 5pm.

Where can I find the study results?

PreFIT is now finished and we have reported the findings. Please see the links below which will take you to the full trial results. The study was funded by National Institute for Health Research. The findings have also been presented to doctors, nurses and other health and social care professionals in the UK.

We would like to thank you again for taking part in PreFIT.

The information that you have provided has been invaluable in helping us work out the best way to prevent and manage falls and fractures.

You can find more information about the PreFIT trial: NIHR Evidence - Advice by mail is as effective as targeted interventions at preventing fall-related injuries in older people - Informative and accessible health and care research

The link to the main scientific journal article in the New England Journal of Medicine is here: