Did they specifically consent to it? It sounds like that wasn't required, which would have some serious ethical implications, since their data was used for (dodgy) research.
Some patients apparently had no choice in whether or not they completed the NOD questionnaires – eg this Cornwall service letter -
CFS/ME Service Minimum Dataset INFORMATION FOR SERVICE USERS
CFS/ME services nationally are collecting standardised information from each new patient being referred to the service as agreed by the CFS/ME Service Investment Programme the agreed Minimum Data Set for outcomes monitoring. This information is used for routine assessment. Collecting routine information to monitor services is standard practice in the National Health Service (NHS). The aim is to help each local service to improve its performance by comparing it with its own previous records and also with the performance of other similar services.
The way to improve services for patients with CFS/ME and their carers is to improve outcomes, for example; improved symptoms, increased function or more social participation.
What information will be collected?
The information relates to the symptoms you may experience and how CFS/ME has impacted on your life, mood and function. It will also reflect the differences in the level of need of people who are referred to each local service. Completion will take approximately 45 minutes.
When will the information be collected?
In order to explore how your symptoms and personal sitiation change overtime, the information needs to be collected at different points in your treatment. You will need to hand in the completed in formation when you come for your first appointment with the service . The information needs to be collected again 12 months later. If you are a younger person it wil be at 6 months and 12 months.
Why this particular information?
This information has been selected by a working group of the National CFS/ME Clinical Network Coordinating Centres Collaborative in order to:
· enable services to monitor their achievements and compare themselves with each other, taking account of different case mixes
· register benefits (outcomes) such as improvements in your well-being and function
· contribute positively to the clinical assessment process.
A lot of effort and consultation have been placed in order to make this dataset as brief as possible and to meet the needs of all stakeholders including, most especially, people with CFS/ME and their families or carers.
How is confidentiality protected? Data collection and storage must comply with local and national guidelines, including Caldicott principles and the provisions of the Data Protection Act. This means that personal confidentiality will be protected rigorously. Data collected from the questionnaires will be stored on computer but only CFS/ME service staff members will have access to it. Central data must be anonymous when collated for analysis. For any audit and research purposes the data will be anonymised, with no means of identifying individuals.
SUMMARY
1
-Please check that the details on
CFS/ME Service Initial Postal Assessment are correct and complete all the other remaining information.
2-Please complete all the questions in the attached
Questionnaires.
3-Bring back the completed forms to your first appointment with the CFS/ME service.
Thank you.
__________________________________________
Others apparently did - eg this Frenchay service letter:
Dear *****,
We have enclosed forms asking you about your illness. If you are able to fill them in before your appointment with us, that would be helpful. The information is used in planning potential care. This information is confidential.
Our aim is to reduce the time you need to spend with us on your first visit. We understand that the effort of getting to the hospital and answering a lot of questions can be difficult.
You are under no obligation to complete the forms, and we can talk to you about your illness and how if affects you at your first appointment. The form will give you some idea of the information we are looking for, even if you choose not to fill it in.
If you have any worries about the forms, or the assessment or our service, please do not hesitate to call us on the number given at the top of the letter.
Please bring the forms to your appointment.
Yours sincerely,
_____________________________
Crawley et al claim that they have not used this data for research, only for service evaluation because it was routinely collected data. Personally I don’t think its usual or routine for NHS clinics to amass this amount of data from their patients before they’ve even set foot in the clinic or been properly diagnosed. And if it was routinely collected data then why did they tell their Frenchay patients that they were under no obligation to complete the forms while the Cornwall patients had no choice? And why has the collection now ended? All rather schizophrenic in my opinion.
And why weren’t the patients told that their data was going outside of the NHS to the University of Bristol? Did the Cornwall service mislead their patients by saying that “only CFS/ME service staff members will have access to it” implying perhaps that it would not leave their hospital/clinic-based service?
Did the Torbay service mislead their patients too with this webpage and video link? - https://www.torbayandsouthdevon.nhs.uk/services/cfs-me-service/ see video from 1 min where patients are reassured regarding confidentiality and that the information they give will only be seen by the team. This is repeated in the Confidentiality statement towards the bottom of this webpage, yet I believe that Torbay was a contributor to the NOD and an image of a NOD questionnaire is shown in the video when the assurance is made.