Trans patient pathways are complex as hell (as two separate GP-led audits from England showed) and involve NHS number change, sex marker change and the use of multiple clinics.
Ooo! Were those audits published?
Gender clinics do not collect outcome data (I am not convinced they collect ANY data)
I would put money on the reason for refusal to cooperate being such sub-standard record keeping that it should lead to disciplinary action, sanctions by professional regulators and a big question mark over whether the GDCs are fit for purpose.
However, that is exactly what the Levy Review found and as far as I know there have not been any consequences for the professionals involved.
Quality (including safety)
"The absence of any patient outcomes data, alongside limited and inconsistent quality data reporting, and minimal clinical audit makes it impossible to properly understand patient outcomes and the safety of these services. These gaps place these clinics outside standard NHS quality assurance expectations."
https://www.england.nhs.uk/long-read/operational-and-delivery-review-of-nhs-adult-gender-dysphoria-clinics-in-england/#quality-including-safety
Detransition
98. The review heard that, following assessment and treatment, some patients express regret or dissatisfaction; a smaller number choose to discontinue or reverse their gender transition. Some later decide to retransition.
99. The number of patients who express some form of regret, dissatisfaction or choose to detransition is unknown due to the absence of GDC outcomes data.
https://www.england.nhs.uk/long-read/operational-and-delivery-review-of-nhs-adult-gender-dysphoria-clinics-in-england/#service-context
Any study will have to involve GP data. Which is decentralised and with no consistent coding. The whole project is of such mind-boggling complexity that I cannot see how it will happen without real manpower and/or time.
I agree. I was involved with a three year multi-centre study that followed patients through to local services to determine outcomes, among other things. There were separate prospective and retrospective components. The prospective component was obviously more manageable and one of the big challenges with the GICs study is that it would necessarily be retrospective.
I am not clear from what has been published whether it is proposed that the original University of York Protocol will be followed or if there have been any modifications.
Protocol Assessment, Management and Outcomes for children and young people referred to a National Gender Identity Development Service
V3.1;03072023
https://www.york.ac.uk/media/healthsciences/documents/research/GIDSFullProtocolv3.125072023.pdf
There are details about the proposed data collection, in response to a FOIR to NHS England, in the zip file here:
https://www.whatdotheyknow.com/request/cassdatadisclosurethreats#incoming-2705431
There is also email correspondence in the zip file confirming that by April 2024 the Adult GICs/GDCs were willing to cooperate with the York Research.
File name: Data Linkage Email Correspondence_Redacted.pdf
From: Derek Glidden
Sent: Wednesday, April 10, 2024 7:54 PM
TO: PALMER, James (UNIVERSITY HOSPITALS PLYMOUTH NHS TRUST)
Cc: [REDACTED] (NHSENGLAND - X24)
Subject: Data Linkage Study
Importance: High
Dear James and [REDACTED]
I am writing to you in my capacity as the NHS England's Gender Dysphoria National Speciality Advisor to say that following discussions with the national GDC Clinical Leads, that I am assured that we as a group will be willing to support the data linkage study progressing and that we are committed to wanting advance the evidence base in our field, especially the short, medium and longer term outcomes.
I am always happy to discuss this further.
Best Wishes,
Dez
Dr Derek Glidden (pronouns he, him, his)
Transgender Healthcare Consultant (Psychiatrist)
Clinical Lead NCTHnet
Clinical Director Transgender Health and Substance Misuse Service
NHS England Gender Dysphoria National Speciality Advisor
Nottingham Centre for Transgender Health Network (NCTHnet)
12 BroadStreet
Nottingham NG1 3AL
In the zip file, also see the NHS England Report, file name:
Item 5 Update on Data Linkage Project CYP Gender Dysphoria ROB 29 May 2024 (2)_Redacted.pdf
NHS ENGLAND
Date of meeting: 29 May 2024
Paper title: Update on the Progress of the Data Linkage Project
Agenda item: 5
Report by: [REDACTED], Senior Delivery Manager, Data Collection and Delivery and Michael Chapman, Director of Data Access and Partnerships
Paper type: For note and discussion.
Sensitivity: Are the contents of this paper OFFICIAL: SENSITIVE Yes
Action Required
The Board is requested to note this paper and to offer any advice ti might have.
Executive Summary
Further to the publication of the final report of the Cass Review in April (the Report), this paper presents the Research Oversight Board with:
- A summary of the current position relating to NHS England's preparedness to provide the University ofYork (UoY) with the data it requires to carry out the quantitative research commissioned by the Cass Review (the Review),
- A summary of the issues currently under discussion.
- Some background information regarding the work carried out to date.
Planned Approach and Study Protocol
The essence of the work is in response to a request from the University of York (UoY) for Hospital Episodes Statistics (HES) records in respect of every patient who attended the Gender Identity Development Service (GIDS) at the Tavistock and Portman NHS FT between 2009 and 2020. This requires:
1 Uploading patient demographic data (postcode, date of birth, sex/gender, NHS number) from GIDS (this is the cohort of patients for whom records are required), the five Gender Identity Clinics (GICs) and the two endocrine services.
2 Verifying each patient’s details and find any records for the same person under a different NHS number.
3 Determining which patients of the adult GICs and endocrine services belong to the GIDS/study cohort (and informing those trusts of this).
4 From the final list of patients (some of whom will have two sets of HES records) producing a final set of records (this is the data extract to be sent to the UoY).
Here is a link to the full study protocol: GIDS protocol - Health Sciences, University of York
Delivery approach
Michael Chapman will provide senior support to a multi-disciplinary team project managed by [REDACTED] within NHS England’s Transformation Directorate. This will initially comprise those who have been involved in the work since the original request for data from the UoY to NHS Digital.
Risks:
Available resource in the Data Science area – can be mitigated by senior support to prioritise this work and/or by agreeing funding and a suitable route for procuring specialist staff.
Available resource in the National Back Office (NBO) – this is a specialist team that can trace health records “by hand” in cases involving incomplete information or where details are ambiguous (e.g. distinguishing between individuals with similar details). Their help may be needed; until the data is seen it cannot be known how much time/effort may be needed from them. This might delay the work. NB A member of the NBO team has been part of the multidisciplinary team since its inception.
It is not known how easy/difficult it might be to find and match records for the same person held under different NHS numbers until the quality of the data is known (i.e. after it has been uploaded to NHS England).
Information Governance Approach
A Statutory Instrument (SI) amending the Gender Recognition Act 2004 laid in June 2022 (allowing records of those who have a Gender Recognition Certificate (GRC) to be matched with their record pre the issue of the GRC) remains in force until June 2027. Organisations specifically named in it can therefore work with the data of those who have a GRC, which is important as, without that, given that it isn’t known who does or doesn’t have a GRC, working with data from this patient cohort would not be possible. However, as the UoY is specifically named in it, the SI would need to be amended were any other organisation to be commissioned to carry out the research.
The Confidentiality Advisory Group (CAG) issued approvals under Section 251 of the Health and Social Care Act 2012 in August 2023 (NB the UoY had applied about a year earlier). This exempted both the UoY researchers and Trust staff from having to obtain individual consent from every patient whose data would be involved in the work on the grounds that this was impracticable (and also acknowledged that the research was a legitimate use of patient data in support of health and social care). This approval remains valid.
The s251 approach was agreed upon by Jackie Grey (Director of Privacy, Transparency, Ethics and Legal in NHS Digital) and the CAG in November 2022 after representations from the Chair of the CAG (initiated under the terms of an MoU on co-operation between NHS Digital and the Health Research Agency) that a Direction would be perceived as an overly proscriptive way to try to obtain the patient data by the patient and stakeholder community.
However, as highlighted by the Report, this approach did not succeed. It is unlikely that the stakeholder community would now perceive the use of a Direction any differently to how it did in 2022, but using a Direction (and the consequent Data Provision Notice creating a legal requirement to submit data) would enable NHS England to consider action in the event that a Trust/clinic continued to refuse to provide its patient data and, in the wake of widespread comment on the refusal of the GICs to co-operate with the research, would signal to both stakeholders and the wider public that their co-operation was now being ensured.
Next Steps
1 Specialised Commissioning is currently in discussion with the UoY regarding restarting its work on the quantitative research.
2 Discussions regarding the IG approach to be adopted will continue (to include consultation with the Chair of the CAG).
Background
The then NHS Digital became involved in the research commissioned by the Cass Review in early summer 2022. At that time the Review’s Interim Report had been published which set out the research that had been commissioned by the Review.
The UoY was commissioned to carry out the quantitative research into outcomes for the cohort of GIDS patients who attended the service between 2009 and 2020. This is about 9,000 individuals. After developing its research protocol and submitting that to the CAG for approval, the UoY made a request to NHS Digital’s Data Access Request Service for the relevant patient records from the Hospital Episodes Statistics.
This request resulted in NHS Digital producing a plan for identifying which patients from the GICs and endocrinology services were part of the GIDS patient cohort and for then identifying all records held for each of those patients. The plan also provides for informing the trusts concerned which of their patients had attended the GIDS service. This would have enabled the UoY to have identified and accessed relevant patient records for a planned further stage of the research that the Report did not recommend was continued. This plan was developed in consultation with the UoY and was designed to ensure that patients could not be re-identified by researchers. NHS Digital developed all relevant Information Governance documentation in relation to its work.
NHS Digital originally planned to obtain the data via a Direction from NHS England. In November 2022 the Chair of the CAG raised concerns about this approach. Ultimately NHS Digital’s Director of Privacy, Transparency, Ethics and Legal agreed with the Chair that Section 251 approvals should be used for the flow of data into and out of NHS Digital. These were granted in August 2023 (after further work with the UoY to satisfy the CAG on other matters e.g. patient involvement). This allowed the UoY to begin to work with trusts on implementing the three-month period that had been agreed upon to allow any patients who wished to do so to opt-out of having their data used in the research. (NB this is separate to the National Data Opt-out which trusts would also have applied when submitting data to NHS Digital).
NHS Digital merged with NHS England in February 2023. This necessitated some further work on the IG after discussion with the Interim Advisory Group on Data (including the consideration of data controllership responsibilities as the Review was commissioned by Specialised Commissioning, with the Review then contracting with the UoY, which then requested data from NHS Digital, which has now merged with NHS England).
As is now well known, trusts refused their co-operation at the point of being asked to implement the opt-out option/period (in November 2023). After the University of York terminated the research the NHS England team stood down but remained in touch with one another awaiting the publication of the Report. That team therefore remains extant and is able to pick up the work from where it was left off (assuming that the research protocol produced by the UoY is not altered, which would require NHS England’s work to be rescoped and replanned).