HEALTH: a randomised comparison of laparoscopic supracervical hysterectomy with endometrial ablation for women with heavy menstrual bleeding - medium-term follow-up at a minimum of five years

The University of Aberdeen requires access to NHS England data for the purpose of the following research project:

HEALTH: a randomised comparison of laparoscopic supracervical hysterectomy with endometrial ablation for women with heavy menstrual bleeding - medium-term follow-up at a minimum of five years

The following is a summary of the aims of the research project provided by the University of Aberdeen:

In the HEALTH trial comparing laparoscopic supracervical hysterectomy (LASH) with endometrium ablation (EA) for heavy menstrual bleeding (HMB), LASH was found to be clinically effective in terms of patient satisfaction at 15 months post randomisation but with higher immediate costs.

Longer-term clinical and economic outcomes of LASH and EA, including further treatment rates, is required to address key uncertainties in our model-based estimates of cost-effectiveness that were extrapolated from the 15-month follow-up data and external literature. The need for longer term data on clinical and economic outcomes for EA and LASH are also highlighted in the Cochrane systematic review of EA and hysterectomy.

Primary Objectives:

To determine medium-term outcomes (5-8 years post randomisation) in terms of:

• Participant reported outcome measures

• Safety and any late onset adverse events

• Need for further treatment

• Cost-effectiveness of LASH versus EA

Secondary Objectives:

• Generic health-related quality of life [SF-12 and EQ5D-3L] scores at 5-8 years post-randomisation

• Need for further treatment within primary and/or secondary care for relevant symptoms (including surgery)

• Late onset side effects of treatment

• NHS care resource use costs up to 5-8 years post randomisation

• Medium-term cost effectiveness, based on extrapolation of the medium-term follow-up data.

• Indirect costs related to participant reported time lost from productive activities due to heavy menstrual bleeding, its treatment, or associated complications

The following NHS England Data will be accessed:

• Hospital Episode Statistics, Admitted Patient Care and Outpatients – necessary to identify any further admissions, re-operations and treatments for heavy menstrual bleeding and other relevant symptoms.

The level of the Data will be:

• Identifiable – necessary because although the data provided by NHS England will contain pseudonymised fields, the University of Aberdeen retain access to the corresponding identifiers. While no efforts will be made to reidentify participants, the technical capability to do so remains.

The Data will be minimised as follows:

• Limited to a study cohort identified by the University of Aberdeen – consisting of 387 participants of HEALTH recruited in England who were due to undergo treatment for HMB, who consented to be contacted about taking part in this medium-term follow up study.

• Limited to data between May 2014 (when the first participant was recruited) and February 2025 [to coincide with the data already obtained from Public Health Scotland

• For each individual patient, data will only be provided from the date they joined the trial [date to be provided by the University of Aberdeen] until February 2025 [to coincide with the data already obtained from Public Health Scotland.

The University of Aberdeen and NHS Grampian are the research co-sponsors. However, the University of Aberdeen is the sole controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above. For the purposes of the medium-term follow up study, NHS Grampian are not considered a data controller.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

The funding is provided by the National Institute for Health and Care Research (NIHR). The funding is specifically for the study/ described. Funding is in place until 31st January 2026.

The funder will have no ability to suppress or otherwise limit the publication of findings.

A trial steering committee made up five independent members (which includes one patient and public representative) will meet during the duration of the medium-term follow-up study. These members are independent from the study team and their institutions. However, the trial steering committee do not make any decisions regarding the data collected and will not have access to the NHS England data nor any participant level data. They will have access to only aggregated level data (with small number suppressed) following analysis and they will be involved in the interpretation of results.

An individual with an honorary contract with the University of Aberdeen – This individual is the Chief Investigator for the HEALTH research project. The Chief Investigator is substantively employed by NHS Grampian but holds an honorary contract with the University of Aberdeen, are the sole data controller for the HEALTH project.

The extended HEALTH follow-up application also includes a patient and public representative on the Project Management Group (PMG) and the Trial Steering Committee (TSC) to ensure continued patient and public input into the management of the research, developing participant information resources, contributing to the reporting of the research and dissemination of research findings.

The University of Aberdeen will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Postcode, Name, and a unique person ID) for the cohort to be linked with NHS England data. The data will also contain the data the patient joint the trial for the purposes of minimisation.

NHS England will provide the relevant records from the HES datasets to University of Aberdeen. The Data will

• contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient

The Data will not be transferred to any other location.

The Data will be accessed onsite at the premises of the University of Aberdeen only.

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

Remote processing will be from secure locations within the UK. The data will not leave the UK at any time.

Data will be accessed by an individual with an honorary contract with the University of Aberdeen. The individual will act as an agent of the University of Aberdeen at all times under supervision from employees of the University of Aberdeen. Aside from this/these individuals, access is restricted to employees or agents of the University of Aberdeen who have authorisation from the Gateway Manager.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

Participants were recruited from across Scotland and England. Therefore, a similar application for routinely collected data from Public Health Scotland has been approved. Once the routinely collected data is received, limited variables will be incorporated into the HEALTH dataset, which already contains participant reported outcomes, prior to analysis.

The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Analysts from the University of Aberdeen will analyse the Data for the purposes described above.

The expected outputs of the processing will be:

• A one-page report of findings to all study participants, published on the study website.

• A report of findings for the Royal College of Obstetrics and Gynaecology and the British Society of Gynaecology Endoscopy (BSGE).

• Submissions to peer reviewed journals.

• Presentations at national and International gynaecological conferences. Expected summer 2026

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Peer-reviewed journals

• National and International conferences

• Press/media engagement

• Reports aimed at participants/patients

This will be dependent on when the routine data is received from NHS England. Participant-reported outcomes have been collected and the routine data application from Public Health Scotland has been approved; therefore, we anticipate the outputs will be produced/disseminated in spring/summer 2026 (6-9 months after the data is received from NHS England).

The findings of this research study are expected to contribute to evidence-based decision-making for policymakers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of women with heavy menstrual bleeding worldwide.

The HEALTH trial is one of the largest multicentre randomised surgical trials undertaken and completed in this field, which achieved high rates of follow-up. Given the lack of other similar trials, longer term follow-up of this trial affords a unique and necessary opportunity to establish medium term clinical and cost outcomes for both techniques but also rates and types of further treatments and any further complications. Given the scale of the trial and the length of follow-up, it is unlikely to be repeated, therefore, maximising outcome information for women, healthcare purchasers and providers is of paramount importance. The need for this evidence is highlighted in two recent Cochrane library reviews.

The results of this research will therefore inform women and health care purchasers of the expected clinical and economic outcomes following either LASH or EA, including need for further treatment and potential impact on livelihood and quality of life five to eight years after initial treatment. Our output will be critical for policy makers, health care commissioning groups and providers, clinicians as well as women suffering from HMB worldwide. There has been no new or ongoing research or publications to improve our knowledge with regards to longer term outcomes following LASH.

In addition, given the pressures on operating theatres in the UK, if the results from the initial trial are maintained, the recommendation should be that those women needing/requesting a general anaesthetic, without contraindications, should be offered a LASH rather than EA. This would encourage a move to outpatient EA which has already been shown to be feasible and also acceptable to women.

It is hoped that through publication of findings in peer-reviewed journals and dissemination of results at national/international conferences, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients with heavy menstrual bleeding.

The team will work with the University of Aberdeen to deliver an effective programme of dissemination of research findings to key stakeholders (NHS commissioners, clinicians, funding bodies, service users/participants, charities and the general public) employing up-to-date innovative methods. The team will specifically engage with platforms relevant to women’s health and maximise opportunities to raise awareness among women and their families to the results of this study and what these might mean for them. This will be accompanied by a press release to maximise exposure to TV, radio, and newspapers, along with planned activity on social media to raise awareness among the general public nationally and internationally. The team will adopt individualised strategies for all stakeholders.

Yielded Benefits is not a requirement for new applications.