Obtaining your medical records via NHS Digital
This patient notification has been posted to clarify one of the ways in which we use EMBRACE recruit’s data. Prior to April 2017, EMBRACE recruits were made aware of, and consented, to medical information being obtained and used for this research. Medical information is mostly obtained through writing to the hospitals where a recruit was treated, however where this is not possible some information can be obtained from NHS Digital (see ‘What is NHS Digital’ section below).
Following newly introduced guidelines this patient notification aims to provide more transparent and clear information to current recruits, up to Apr 2017, as to the role of NHS Digital. From April 2017 new more informative versions of the consent forms and patient information sheets will be used at recruitment to meet with the new guidelines.
The EMBRACE study is an epidemiological study that has been recruiting since 1998. It involves looking at people and their families that may have an increased risk of breast, ovarian or prostate cancer, as a result of inheriting mutations in specific genes. In order to understand how these mutations and other factors interact to influence the cancer risk to these people, information about a recruit’s lifestyle and health along with blood samples are obtained. One key aspect of EMBRACE is to obtain information about the past and ongoing health status of recruits, in particular any cancer diagnoses. We partially achieve this through the questionnaire(s) that our recruits kindly fill out for us. In addition, however, we also send some basic details for each recruit to NHS Digital so that we can receive notification of any cancer diagnoses. This enables a complete record to be obtained on all recruits, which is very important in order to obtain reliable results from the study.
What is NHS Digital?
NHS Digital is sponsored by the Department of Health and has multiple purposes, including the collection and processing of data. You can find out more from their website here [https://digital.nhs.uk/about-nhs-digital].
What information is sent to (and received from) NHS Digital?
Identifiable data including your name, address, date of birth and NHS number are supplied by us to NHS Digital to enable EMBRACE to obtain data from your medical records. We do not send them information on your health. The information we send is only needed to match you to the correct records that NHS digital already have through GPs, birth records, hospitals etc.; we are not proving new information to NHS Digital.
We will receive details from the NHS Digital on a periodic basis regarding any cancer diagnoses that study participants may have had. This will include the date of diagnosis and a code to indicate the type of cancer. NHS Digital will also provide us with information from the Office of National Statistics (ONS – https://www.ons.gov.uk/aboutus) about those who may have passed away since the start of our study, including date and cause of death.
Why is this done, what are the benefits?
There are three main benefits to obtaining the data from NHS Digital and the ONS.
- It acts as confirmation of your past diagnoses of cancer, if applicable. It also helps add to that data by providing the date and subtype of cancer. For example, some mutations predispose a person to a higher risk of specific ‘types’ of breast or ovarian cancer. These cancers are no longer considered as ‘one’ disease and as such treatments can be tailored and made more effective. Obtaining this information from NHS digital, and where we can from medical pathology records, is essential in providing more clues as to how these cancers can be treated or prevented..
- It provides up to date information on any cancer diagnoses since your last questionnaire. Some of our recruits will only receive the initial (baseline) questionnaire so this becomes our sole means of follow up in such cases. Recruits that fill in follow up questionnaires will do so after large intervals (up to five years), so NHS Digital helps to keep our data current during these gaps.
- The ONS data provides vital data for survival analysis, but also helps to prevent us inadvertently contacting relatives of deceased participants.
In essence it helps ensure that the results of the study are as accurate as possible.
Can I opt out?
You can contact us to opt out of data collection via NHS Digital & the ONS. In addition, participants are free to withdraw from the Embrace study at any time (http://ccge.medschl.cam.ac.uk/embrace/fair-processing-data/). If you would like to contact us please tell us by writing, telephone or e-mail using the contact details below.
Centre for Cancer Genetic Epidemiology
Strangeways Research Laboratories
Cambridge CB1 8RN
Tel: 01223 740617
You don’t have to give a reason. Your decision will have no effect on your care or treatment in the future.