Without data, you’re just another person with an opinion.”W. Edwards Deming
Last week I sent a letter to NHS England, expanding on the advice in my interim report, and giving more detail about the proposed new regionalised model of care for children and young people questioning their gender identity or experiencing gender related distress. I recognise that it will take time before the staff and structures of the proposed regional services are in place. More immediately, I know that NHS England is setting in place interim arrangements to ensure the continuity and safety of current services.
NHS England also asked for advice on how to address the gaps in the evidence base that were flagged in my interim report, and I want to say a little more about that here.
I have explained previously the three components of the research commissioned by the Review: a comprehensive literature review focused on the questions that were set out in our terms of reference from NHS England; a qualitative study to understand more about the experiences of service users, parents and carers, and professionals, including young adults up to age 30; and a quantitative study to try and fill some of the gaps in follow-up data for the approximately 9,000 young people who have been through the Gender Identity Development Service (GIDS), many of whom are now adults.
Over the last few weeks, I have been concerned about the distress generated by the laying of the statutory instrument (SI) which was required before the proposed quantitative study commissioned by the Review could be considered by the Research Ethics Committee (REC) and the Confidentiality Advisory Group (CAG). Unfortunately, there was a lot of misinformation about both the purpose of the SI and of the research itself. Concern was also expressed that the research might not be subject to the proper ethical scrutiny and approval processes. During the last month we have had discussions with members of the community and advocacy groups to address the questions that have been raised about this. The most important points to share are that:
- The purpose of the research study is to understand the range of service use and outcomes of young people who have been through the GIDS, and there will be involvement of service users in interpreting any data that is generated.
- We were unfortunately not able to discuss the SI in advance because it was Department of Health and Social Care policy in development; however, our webpages now give detailed information about the reasons for the SI, the protection of data, and the very tight limitations on access and use.
- The research will go through all normal ethical and research approvals, and no records will be accessed until and unless those approvals are received.
- Subject to approval from REC and CAG the full protocol will be published on our website along with details about how you can opt out of the study should you wish to do so.
Fuller details can be found on our research pages.
Obviously looking at pre-existing data (retrospective research) is never as good as planning research going forward (prospective research); in prospective studies it is much easier to agree the research questions, involve service users in designing the studies, obtain consent and collect the necessary data. In my letter to NHS England I have highlighted some of the questions that we need to address prospectively and have emphasised the collaborative work that will need to be undertaken to incorporate these into a comprehensive research programme.
As Edward Deming said, “scientific data are not taken for museum purposes; they are taken as a basis for doing something.” Improving the level and quality of evidence will enable young people seeking NHS support, their families and carers, and clinicians to have better information to help them determine the best support and interventions for them as individuals.