NHS Digital Data Release Register - reformatted
Glasgow Caledonian University projects
- MR1487 - Prolong20+ Longitudinal study of pelvic floor dysfunction and relationship to childbirth: Access to current names, addresses and mortality statuses.
11 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).
MR1487 - Prolong20+ Longitudinal study of pelvic floor dysfunction and relationship to childbirth: Access to current names, addresses and mortality statuses. — DARS-NIC-250100-R3W1G
Type of data: information not disclosed for TRE projects
Opt outs honoured: Yes - patient objections upheld, Identifiable, Yes (Section 251 NHS Act 2006)
Legal basis: Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 s261(7)
Purposes: No (Academic)
Sensitive: Non Sensitive, and Non-Sensitive
When:DSA runs 2019-08-01 — 2020-07-31 2019.09 — 2019.09.
Access method: One-Off
Data-controller type: GLASGOW CALEDONIAN UNIVERSITY
Sublicensing allowed: No
- MRIS - List Cleaning Report
ProLong20+ is a longitudinal study investigating the long-term consequences of childbirth on urinary incontinence (UI), faecal incontinence (FI), pelvic organ prolapse and sexual dysfunction, known collectively as pelvic floor dysfunction (PFD). PFD in women in middle to later life is common, detrimental to health and well-being, and increasing in prevalence. There is increasing evidence to suggest that these problems may be consequences of, or are exacerbated by, pregnancy and delivery.
In 1993-94 ~8,000 women living in Aberdeen (Scotland), Birmingham (England) and Dunedin (New Zealand) took part in the ProLong study, three months after giving birth. They completed a short incontinence questionnaire at that time which revealed that 33% had UI and 8% had FI. Further questionnaires were completed at 6 years when 45%/10% of the women had UI/FI, and at 12 years when 53%/13% had UI/FI. Prolapse was measured at 12 years and found in 24% of the women.
ProLong20+ aims to contact the UK-based ProLong study participants again. Many of the women will be now be around the age of the menopause when PFD is thought to be even more common. The women will be asked to take part in a postal questionnaire. An invitation will also be extended for the women to attend a pelvic floor examination.
Glasgow Caledonian University is the sole data controller for this study and also processes the data disseminated under this Agreement.
The University of Birmingham, Dunedin School of Medicine (New Zealand) and University of Aberdeen were involved in the original ProLong Study and are named in the study protocol for this reason. However none of these organisations are involved in the decisions regarding the collection of data under this Agreement for the ProLong20+ study, nor will they access any data other than at an aggregated (with small numbers suppressed) level.
The data requested will be processed under Article 6(1)(e) and 9(2)(j) of the GDPR. The outcome of this research is in the public interest because it will benefit the Health and Social Care Services within the UK, due to steady increase in
pelvic floor dysfunction being reported within the cohort in previous follow-ups.
Glasgow Caledonian University have deemed that there are unlikely to be any moral or ethical issues arising from this research as the cohort consented to participate in the original study and section 251 support is in place to request the data under this Agreement.
The study is overseen by a Project Management Group (PMG) which makes decisions about the running of the study and meets monthly to discuss study progress against the schedule, delays and any issues, such as potential budget overspend. A number of the PMG members are clinicians and researchers who were involved in the very first data collection from the ProLong cohort back in 1993-94 and use their experience working in the field to provide guidance to the study team. The PMG does not make any decisions on the data that is collected under this Agreement. Only members of the PMG who are substantive employees of the data controller, will have access to the data disseminated under this agreement. All other members will only access aggregated outputs (with small numbers suppressed).
Funding is provided by the Chief Scientist Office (CSO) which is part of the Scottish Government and is therefore categorised as a public body. The funding start date was 01st April 2018, however the funding period included all preparatory work, for example, ethics and CAG approval.
This research comprises an observational study of the UK-based arm of the ProLong longitudinal cohort. Cohort members were first invited to take part in a survey in 1993-4 following the birth of a baby at one of three maternity units (Aberdeen or Birmingham in the UK, and Dunedin in New Zealand). Two further surveys of the same cohort were undertaken 6 and 12 years later.
This Agreement permits use of a list cleaning service in order to facilitate contact with the English cohort members to ask them to take part in the ProLong20+ Study and to consent to the following:
i) to complete 2 x questionnaires regarding details of their current health (patient reported outcomes)
ii) to take part in a pelvic floor examination
iii) Hospital Episode Statistic data regarding the participant being obtained from NHS Digital.
The HES data will be requested from NHS Digital under a future application, using that consent to meet the common law duty of confidentiality.
This Agreement does not permit access to any NHS Digital data on the basis of consent.
The current follow-up study, ProLong20+, is being run by the Nursing, Midwifery and Allied Health Professions Research unit at Glasgow Caledonian University and will collect data from cohort members recruited in the United Kingdom (UK) only.
Under this Agreement data is requested for the English members of the cohort, recruited via the Birmingham Maternity Unit, totalling approximately 3,700. A separate process has been carried out to request data from NHS Scotland for those participants originally recruited in Aberdeen.
The cohort were recruited in 1993-1994 and consented to participate in the study. For the list cleaning service requested under this agreement, support under section 251 of the NHS Act 2006 has been obtained. Section 251 support was sought as the HRA determined that the previous consent did not explicitly permit further contact with the cohort members.
Up-to-date contact information for study cohort members is being requested from the NHS in order to maximise the response rate from the postal survey by using accurate names and address for study correspondence. The mortality status of cohort members is also being sought in order to avoid sending questionnaires to the addresses of cohort members who are now deceased.
More accurate knowledge of how PFD changes over time will help to estimate the burden for women and the NHS in the future. In particular, the menopause is a life stage associated with physical changes for women which impact on PFD. This longitudinal study gives a unique opportunity to quantify this by studying the symptoms reported by a large group of women who have given birth and across the menopause (58% of women in the cohort are now aged ≥51).
Glasgow Caledonian University hope to invite 3,700 ProLong cohort members who were originally recruited in Birmingham to take part in the current study. As GCU have already received up-to-date name, address and mortality status data from NHS Scotland for the cohort members recruited in Aberdeen, GCU are able to estimate the numbers of Birmingham cohort members who have moved, changed their names or died since the last data collection 12 years ago. Hence, access to up-to-date name, address and mortality status information for cohort members originally recruited in Birmingham will:
- Maximise the response rate for the study - Approximately 38% of the cohort members originally recruited in Aberdeen have moved since the last data collection. Assuming a similar proportion of Birmingham cohort members have moved, access to this information will allow us to invite approximately 1,400 more women to take part in the current data collection. As GCU are expecting around a 48% return rate for the study questionnaires, this could result in 675 more completed questionnaires compared with using the address information currently held for cohort members.
- Minimise the risk of offending cohort members by using the wrong name - 11% of the Aberdeen cohort had changed their surnames since the last data. This would be equivalent to nearly 400 women from the Birmingham cohort.
- Minimise the risk of causing potential distress to cohort members' family or friends by mailing a questionnaire to the address of someone who has died. Sadly, 1.5% of the Aberdeen cohort members had died since the last data collection which would equate to 56 Birmingham cohort members if a similar mortality rate applies.
A subgroup of 414 of the ProLong cohort members took part in the PREVPROL secondary prevention trial in which half were randomly selected to have Pelvic Floor Muscle Training (PFMT) (Hagen 2016). The opportunity for further follow-up of these trial participants would provide evidence as to whether the benefits observed at 2 years are maintained, and whether PFMT is an intervention to be recommended to women known to be at risk of PFD. The public health and NHS cost impacts of these findings are potentially large. The proposed study would gather these data as part of the wider ProLong20+ follow-up.
Results will be used to inform the relevant communities of the epidemiology of PFD using GCU's links with the International Continence Society (ICS) and the International Uro-gynaecological Association (IUGA) and their respective annual conferences, websites and publications. Specific journals cannot be named as it is not possible to predict where the material may be accepted, however publications will be targeted at international journals such as The British Journal of Obstetrics and Gynaecology (BJOG) and The Lancet. Health services will be able to use this information for future resource planning, knowing what proportion of females will potentially seek treatment for PFD.
Glasgow Caledonian University will also distribute information widely through professional and health service networks. It is expected that the study findings will inform national and local guidelines relating to PFD. Most importantly, the aim is for the findings to reach women at potential risk of developing PFD by disseminating through social media and relevant consumer groups. GCU will do this with the help of the consumer advisor on the research team.
The direct outputs expected from obtaining the list clean are:
- Maximise the response rate for the study by allowing the researchers to use the up-to-date address information to provide tan invite cohort members who have moved since the last study, as well as those who are still at the same address. This will give as many cohort members as possible the opportunity to take part if they wish, or to clearly state that they wish to withdraw from further contact.
- Minimise the chance of someone living at the previous address of a cohort member finding out the cohort member has previously taken part in a study about incontinence.
- Minimise the chance of someone living at the previous address of a cohort member completing and returning the questionnaire themselves (this has happened in previous study data collections, despite the letter not being addressed to the current home owner).
- Reduce the risk of offending cohort members by addressing correspondence to them using a name which they may not have used for several years.
- Minimise the risk of causing potential distress to cohort members' family or friends by mailing a questionnaire to the address of someone who has died.
Glasgow Caledonian University (GCU) will send NHS Digital a file of approximately 3,700 ProLong cohort members in a comma-separated values (CSV) format file. This file will contain the details of cohort members who were originally recruited via the maternity unit in Birmingham in 1993-94 only. Any cohort members known to have died or to have withdrawn/opted out of the study will be excluded.
The following data items will be provided for each cohort member in the cohort file:
- Prolong Study ID
- Date of birth
- NHS Number
The identifying details supplied by GCU will enable NHS Digital to carry out matching of the participants to their data records. A secure file transfer method will be used to send the cohort file to NHS Digital.
NHS Digital will use an automatic matching process to match the identifiers provided for the cohort members against Personal Demographics Service data in order to obtain up the most up-to-date name, address and mortality status information held by NHS Digital.
No information will be provided for any cohort members who have registered for the National Opt Out Programme.
NHS Digital will supply the following details to GCU for each matched cohort member in a CSV file:
- Prolong Study ID
- Latest surname
- Latest forename(s)
- Date of birth
- Latest postcode
- Latest address
- Dead or Alive Status Flag
- Exits and re-entries to the NHS
For patients found to be deceased, only fact of death and no updated address details will be provided.
The information supplied will allow the study team to send out correspondence to cohort members using up-to-date postal addresses, taking account of any name changes and reducing the risk of sending correspondence to cohort members who have died since the last study data collection.
A secure file transfer method will be used to send this matched data file to GCU.
The matched cohort data file supplied by NHS Digital will only be processed within GCU. The data will be loaded onto the ProLong20+ administrative database which is stored on a secure university network drive located in the GCU Data Centre. Access to this database is restricted by network security to two study team members only (plus essential IT support personnel). All ProLong20+ cohort members’ contact information is held in this secure database and the information supplied by NHS Digital will allow the most up-to-date information to be used when addressing envelopes to be posted out to cohort members still living in England to invite them to take part in the current data collection. The data supplied by NHS Digital will not be linked with any other record level information.
For information, once the postal survey is complete, Glasgow Calendonian University plan to submit a further application to NHS Digital to request medical records (HES data) for those of the cohort who have consented to this further follow-up. This is not permitted under this Agreement.
Once the study is complete, contact information for cohort members will be deleted with the exception of the following information for those members who have agreed to future contact from the study only: Name, Date of birth, NHS/CHI number, post code, gender. Information stored on Glasgow Caledonian University (GCU) data drives is automatically backed up on a daily basis onto tape. The tapes are collected and stored by Disaster Recovery Services LTD (DRS). No access or processing takes place at DRS. If a backup tape is required, it is requested by GCU and any processing to access the data on the tapes is carried out at the GCU data centre.
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 i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).