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UK: Chronic Fatigue Syndrome/Myalgic Encephalomyelitis National Outcomes Database

Discussion in 'General ME/CFS News' started by Nellie, Nov 23, 2017.

  1. Nellie

    Nellie Established Member (Voting Rights)

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    I had no idea that a 'Chronic Fatigue Syndrome/Myalgic Encephalomyelitis National Outcomes Database' existed.

    Does anyone know when it started and when it stopped?
     
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  2. MeSci

    MeSci Senior Member (Voting Rights)

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    It seems to be the CFS/ME National Outcomes Database by most references, and was supposedly collated by Bristol University, i.e. the Crawley mob. It seems to have been going since at least 2011 and disappeared this year. Interesting...
     
  3. Wonko

    Wonko Senior Member (Voting Rights)

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    Makes perfect sense in that case, through the method of redefining ME as CFS, and then as CF, and then as F, and developing a "treatment" for F, which is 100% effective, if the client tries hard enough, why would a database be needed for a condition that no longer exists?

    Job done, it's taken a long time but through the efforts of lots of well rewarded people, over decades, ME has been successfully redefined so that in their minds there are no longer any pwME.

    It's perfectly possible to not just see the insanity, but smell it as well, from here.
     
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  4. MeSci

    MeSci Senior Member (Voting Rights)

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    Doing some more digging: from http://www.bristol.ac.uk/social-community-medicine/people/esther-m-crawley/research.html

    "Simon Collin now runs the CFS/ME National Outcomes Database, which collects assessment and outcome data from 26 adult and 4 paediatric teams across England. This is the largest CFS/ME disease register in the world, with assessment data on more than 7000 adults and 1500 children with CFS/ME. It provides the infrastructure for a variety of projects in children and adults."
     
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  5. Esther12

    Esther12 Senior Member (Voting Rights)

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    I didn't know that the NOD had stopped. The results seemed pretty poor - maybe it was seen as embarrassing? When Simon Collin left MEGA it was said that he was also leaving Bristol.
     
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  6. Lilpink

    Lilpink Established Member (Voting Rights)

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    I have been passed this information from someone who recently submitted a FOI request to Bristol about the NOD.



    Recent response (October 2017) from Bristol University to FOI request for information (September 2017) about the National Outcomes Database (NOD):



    Freedom of Information Request: National Outcomes Database (FOI17- 328)

    I refer to your Freedom of Information Request received on 7th September 2017. Further to Section 1 of the Freedom of Information Act 2000 (the “Act”) we confirm that the information requested is held by the University of Bristol (the “University”).

    The information you have requested follows your questions below.

    Your Request

    I would like to make a Freedom of Information request for information about the National Outcomes Database (NOD) for CFS/ME that contains NHS patient data collected since around 2004 or earlier and that has been managed by the University of Bristol. This NOD Database appears to have been set up and managed/run by Professor Esther Crawley and has been subsequently been passed to Dr Simon Collin to run (both from the School of Social and Community Medicine). Please answer the following questions in relation to this database:

    1. When was the National Outcomes Database (NOD) set up/started?

    The NOD was a centralised repository of routinely collected CFS/ME Minimum Data Set (MDS) data. These data were collected (routinely) by clinical teams around the country for a period of time predating the start of the NOD. The collation of data in the NOD began in mid-2004, starting with data from the Bath paediatric and Bristol adult CFS/ME services.

    2. What was the date of the first entry into the NOD database?

    The date of clinical assessment of the first adult patient is 10/08/2004.

    The date of clinical assessment of the first paediatric patient is 26/04/2004.

    3. Is data still being collected for the NOD database?

    No.

    4. If not, what was the last date of entry of patient data into the database?

    The date of clinical assessment of the last adult patient is 18/05/2016.The date of clinical assessment of the last paediatric patient is 13/03/2016.

    5. How many patients - both adult and paediatric - are represented on the NOD database currently?

    18139 adult patients.

    2390 paediatric patients.

    6. How many patients - both adult and paediatric - have contributed to the NOD database in the past?

    As above (subject to response to question 7 below).

    7. Has patient data been removed from the NOD database at any time? If so, why?

    Patient data was removed if so requested by a patient via the contributing clinical team. The numbers were very small (fewer than 10 over the life of the database).

    8. Who manages the NOD database now?

    The NOD is no longer active.

    9. Where is the NOD data stored?

    NOD data is stored in a database on a University of Bristol server.

    10. Who has access to the NOD data? (names are not necessary here - just numbers of people who have access and the organizations they belong to)

    All members of the CFS/ME research team at the University of Bristol potentially have access to the NOD data.

    11. If data is no longer being entered into the NOD then what has happened to this database? - Where is the data/database stored now?

    See question 9.

    12. Has patient data been destroyed or moved?

    No.

    13. If the data/database has been moved then where has it been moved to and who are the person/s and organization responsible for it now?

    The database has not been moved.

    ____________________________________________________________________


    The following review of Bristol’s response was requested. (Note a mistake was made by the requester of the review and soon after corrected in a separate email to Bristol)

    The review request:



    I am requesting a review of the following two points arising from your FOI response to my request.



    • I am confused by the following numbers given in your response to my Freedom of Information request:




    "5. How many patients - both adult and paediatric - are represented on the NOD database currently?

    18139 adult patients.

    2390 paediatric patients. "



    These numbers do not seem to correlate with the published numbers of NOD participants, either in published papers or in other online releases of information about the NOD. They do however seem to correlate more closely with the numbers given on this website for the ALSPAC cohort - http://www.bris.ac.uk/ccah/seminars/2017/esthers-inaugural.html - which is clearly a different cohort altogether. Could you therefore review this information that has been released to me and confirm that these numbers given to me were correct, or correct them now.

    • Also, in relation to question 8 and your response to it:
    "8. Who manages the NOD database now?

    The NOD is no longer active."

    ....a database that is inactive surely still has to be managed in some way and there should be a designated data controller. Presumably its security must be checked and updated and any requests for information from it must be overseen and managed. Also someone must be responsible for overseeing the correct destruction of this database at the point in the future when this happens. I would therefore ask that you review your answer to question 8 and tell me who manages the database now - i.e. which person or department (if no one person has overall responsibility) now has responsibility for it.

    _______________________________________________________________

    Correction email:

    Apologies -



    I have realised that I misread the information given on this website http://www.bris.ac.uk/ccah/seminars/2017/esthers-inaugural.html -and that the numbers quoted are not for the ALSPAC. However please could still review the figures that I was given in answer to question 5 since they still do not closely match with those given in the published papers about the NOD. There would have had to have been a massive increase in recruitment to the NOD between 2014 and 2016 for these figures to make any sense. Please could you also review question 8 as requested below.

    ________________________________________________________________________

    Review response from Bristol University:

    We apologise for the delay in providing clarification on the two points that you raised. We have noted your subsequent correction. Additional information relating to your request is set out below, to be incorporated in the original response:

    5. How many patients - both adult and paediatric - are represented on the NOD database currently?

    Please could you still review the figures that I was given in answer to question 5 since they still do not closely match with those given in the published papers about the NOD. There would have had to have been a massive increase in recruitment to the NOD between 2014 and 2016 for these figures to make any sense.

    Patients are not 'recruited' to the NOD. The NOD is a centralised repository for routinely collected data. The numbers in the NOD include patients who were not diagnosed with CFS/ME (or whose diagnosis was not confirmed as CFS/ME) following assessment, and/or patients who did not receive or complete a programme of treatment at specialist services. For these patients, the NOD would contain only baseline (assessment) data. Published papers typically use a subset of data in the NOD, depending on the research question, e.g. those with a confirmed diagnosis, those who were assessed by a specialist service during a defined period of time and/or those who were assessed by specific services. This is why the numbers in studies are much lower than the total numbers represented in the NOD.

    8. Who manages the NOD database now?

    ....a database that is inactive surely still has to be managed in some way and there should be a designated data controller. Presumably its security must be checked and updated and any requests for information from it must be overseen and managed. Also someone must be responsible for overseeing the correct destruction of this database at the point in the future when this happens. I would therefore ask that you review your answer to question 8 and tell me who manages the database now - i.e. which person or department (if no one person has overall responsibility) now has responsibility for it.

    The database resides on a secure server, with security provided (revised and updated as necessary) by the University of Bristol Information Service, who will also provide guidance on data deletion when this takes place. The NOD is no longer open to requests for information (assuming the question relates to requests for data).
     
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  7. Valentijn

    Valentijn Moderator Staff Member

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    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.
     
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  8. chrisb

    chrisb Senior Member (Voting Rights)

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  9. Lilpink

    Lilpink Established Member (Voting Rights)

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    I agree. I think these answers create a slew of new questions...
     
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  10. Lilpink

    Lilpink Established Member (Voting Rights)

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  11. MeSci

    MeSci Senior Member (Voting Rights)

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    There seems to be a discrepancy between:

    "7. Has patient data been removed from the NOD database at any time? If so, why?

    Patient data was removed if so requested by a patient via the contributing clinical team. The numbers were very small (fewer than 10 over the life of the database)."

    and

    "12. Has patient data been destroyed or moved?

    No."
     
  12. Lilpink

    Lilpink Established Member (Voting Rights)

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    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.
     
  13. Lilpink

    Lilpink Established Member (Voting Rights)

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    Lilpink said


    "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. "

    In answer to my own question:

    My elves have been working on this and it seems that this webpage for the Torbay and South Devon CFS/ME service was most likely created in 2016 after the NOD collection had ended, and they likely used an old NOD questionnaire to illustrate their video, so the answer to this particular question is probably 'no', they didn't mislead their patients with this webpage and video link.
     
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  14. Lilpink

    Lilpink Established Member (Voting Rights)

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    Referring again to the letter/information sheet sent to patients in Cornwall entitled "CFS/ME Service Minimum Dataset INFORMATION FOR SERVICE USERS" (#31) :



    This information sheet states that the questionnaires will take about 45 minutes to complete, so that's about an hour and a half in total, quite a burden on the patient. 'Burden' on the patient is supposed to come into the equation when deciding whether a data collection can satisfy the criteria for being a routine 'service evaluation' exercise collection or not. It is expected that for service evaluation/audit that the burden on the patient should be minor, just the filling in of a questionnaire perhaps taking a few minutes. I'm sure that the copious NOD questionnaires, mostly completed at home, far surpass what would normally be expected, and in many cases the patients were asked to post back the second batch of forms at the end of treatment or at the 12 month mark - an added burden. (In the case of Frenchay in 2010 they even needed to supply their own stamp!)

    The number of NOD questionnaires was increased over time, and was made more intrusive by the addition of searching questions about employment and benefits. I suspect that the completion of the forms became compulsory at some point, (NB the Frenchay letter was from 2009), perhaps when some bright spark pointed out to Crawley that the forms needed to appear be a routine collection, rather than a non-obligatory request of the participants, in order to satisfy the 'service evaluation' criteria.
     
  15. chrisb

    chrisb Senior Member (Voting Rights)

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    There is something in that statement of May 2017 that is niggling me.

    "We have received confirmation from (the ethics committee) indicating that the work Professor Crawley and her team is undertaking in relation to the database analysis is categorised as Service Evaluation. This is supported by the requirements set out in the ...governance arrangements for Research Ethics Committees: "REC review is not required for the following kinds of research: Research limited to secondary use of information previously collected in the course of normal care (without an intention to use it for research at the time of collection) provided that the patients or service users are not identifiable to the research team in carrying out the research."

    There must be questions about whether all the information collected was collected in the normal course of care, and whether there was intention to use it for research at the time of collection.

    One could almost persuade oneself that some senior person outside the usual loop has finally looked at the arrangements and found them wanting.

    EDIT I take "information previously collected in the course of normal care" to mean information normally and routinely collected for the purposes of normal care and not extraneous information collected whilst under the care of a clinician.
     
    Last edited: Nov 25, 2017
  16. Lilpink

    Lilpink Established Member (Voting Rights)

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    There appears to have been clear intent to use either the data or the database for future research purposes (as a supposed 'secondary use') AT the time of collection of the data. This is what Crawley apparently alluded to in her "The Future of Research in CFS/ME" 2010 talk (if the transcript is accurate) - https://meagenda.wordpress.com/2010...presentation-the-future-of-research-in-cfsme/ (from slide 15 onwards referring to Holgate) , what Simon Collin expressed in a University of Bristol presentation entitled "National Outcomes Database" in March 2011 (now taken down from online) - where he stated that a purpose of the NOD was also providing infrastructure for future research, AND......, most indisputably, ....... what is stated about the NOD in the yearly Action for ME accounts of 2009 - " The Database information will then become capable of supporting large scale biomedical research such as Genome Wide Association studies."
     
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  17. Lilpink

    Lilpink Established Member (Voting Rights)

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    re #16

    The intent to use the NOD for future research purposes appears to have culminated in this proposal that was apparently approved (after how much deliberation?) in January 2012 https://proposals.epi.bristol.ac.uk/?q=node/120290 . 'Exploit' seems a rather apt word for them to use here. Were NOD patients contacted I wonder......and did they give samples to this 'Biobank'? If so, how many patients donated samples? And which 4 services were recruited to collect the blood samples? Did they collect any?

    Questions, questions!
     
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  18. MeSci

    MeSci Senior Member (Voting Rights)

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    Answer from Lord O'Shaughnessy at http://www.parliament.uk/business/p...nts/written-question/Lords/2017-11-22/HL3499/

    The chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) National Outcome Database was developed by three NHS Clinical Network Co-ordinating Centres in 2006 and managed by Bristol University. Its development was part of a wider initiative to establish services for CFS/ME in the National Health Service at the time. Neither the Department nor NHS England has oversight of it, or responsibility for it.
     

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