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NHS Evidence Advisory Committee Meeting - Minutes

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					      NHS Evidence Advisory Committee Meeting - Minutes
The following notes are a summary record of the main points discussed at the meeting and the
decisions made. It is not intended to provide a verbatim recollection of the Board's/Committee's
discussion. The agenda and the full documents considered are available in accordance with the
Institute's Publication Scheme.



Minutes: Confirmed


NHS Evidence Advisory Committee Meeting


Date and Time:      10th March 2010, 10.30am – 3pm
Place:              The Red Rooms, Floor 24 City Tower, Piccadilly Plaza,
                    Manchester M1 4BD


Present:                1. Mr Richard Brownhill

                        2. Dr Brian Fisher

                        3. Professor David Haslam

                        4. Dr Monica Lakhanpaul

                        5. Professor Stuart Logan

                        6. Professor Jon Nicholl

                        7. Dr Carl Parker



                    Deputies
                        1. Ms Lynda Cox (for Stephen Singleton)

                        2. Ms Parul Desai (for Mark Davies)

                        3. Ms Julie Robinson (for Amanda Edwards)
In attendance:


Stephanie Birtles   Technical Analyst Accreditation
                    NHS Evidence
                    National Institute for Health and Clinical Excellence

Sarah Chalmers      Project Manager
                    Patient and Public Involvement Programme
                    National Institute for Health and Clinical Excellence

Paul Chrisp         Associate Director for Accreditation
                    NHS Evidence
                    National Institute for Health and Clinical Excellence

Maggie Derry        Project Manager for Accreditation NHS Evidence
                    National Institute for Health and Clinical Excellence
                    (Note taker)

John Huston         Technical Analyst Accreditation
                    NHS Evidence
                    National Institute for Health and Clinical Excellence

James Stone         Accreditation Coordinator
                    NHS Evidence
                    National Institute for Health and Clinical Excellence
                    (Note taker)




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                                   Part 1 - Closed Session

Welcome

1.     The Chair welcomed all members of the committee and other attendees present to the
       meeting. The Chair asked all those present to introduce themselves.

2.     Apologies were received from:


        1 Sir Neil Douglas
        2 Ms Amanda Edwards
        3 Ms Diane Gwynne-Smith
        4 Dr Bobbie Jacobson
        5 Professor Sandy Oliver


3.     The Chair reviewed the agenda and timescales for the meeting and advised of a
       change to the listed presenter, Andrew Miniuks, for item 8 ‘User statistics’. This item
       would now be presented by Paul Chrisp.

     3.1.         The Chair reminded the committee that this would be a public meeting, and
                  that indicated sessions, including Any Other Business, would be open. The
                  Chair described the role of the closed sessions at the start and the end of
                  the meeting.

4.     The Chair asked all committee members to report any amendments to the
       unconfirmed minutes from the previous Advisory Committee meeting held on 20
       January 2010 which have not previously been reported and logged prior to the
       meeting.

     4.1.         The committee members agreed the minutes from the previous Advisory
                  Committee meeting held on 20 January 2010 as accurate and confirmed.

5.     Matters Arising

     5.1.         The Chair announced the following members have stepped down, with the
                  exception of Dr Mark Davies whose will not be renewing his membership at
                  the expiration of the current term of the committee on 31 March 2010. Those
                  members who have stepped down will also not be renewing their

                                                                            Page 3 of 14
                 membership.

        5.1.1.         Ms Catherine Mercer

        5.1.2.         Dr Mark Davies (term expires at the end of March)

        5.1.3.         Professor Martin Eccles

        5.1.4.         Sir Muir Gray

        5.1.5.         Dr Sheila Shribman

        5.1.6.         Mrs Julie Wood

        5.1.7.         Ms Diane Gwynne-Smith (who will become Amanda Edwards’
                       deputy)

        5.1.8.         Sir Neil Douglas will be stepping down from the Committee as
                       representative for the Academy of Medical Colleges, to be replaced
                       by Mr John Lee (President of the Royal College of Opthalmologists)

6.     Concerning the recruitment of new members for the NHS Evidence Advisory
       Committee, the Chair explained that forty-seven professional and nine lay applications
       have been received, and all are to a very high standard.

7.     Regarding voting, the Chair explained that the third option to request further
       information would be made available at the Chair’s discretion.

                                    Part 2 - Open Session

8.     The Chair welcomed the public and explained that the decisions of the committee are
       recommendations to NICE, subject to approval by the Publications Executive. The
       public were also reminded that no audio or visual recording of the meeting is
       permitted.

9.     Declaration of Interests

     9.1.        The Chair asked all committee members to declare any relevant interests
                 specific to the agenda.




                                                                           Page 4 of 14
9.2.        The following members declared no interests:

   9.2.1.         Mr Richard Brownhill

   9.2.2.         Ms Lynda Cox (deputising for Stephen Singleton)

   9.2.3.         Ms Parul Desai (for Mark Davies)

   9.2.4.         Ms Julie Robinson (for Amanda Edwards)

9.3.        The following members declared interests as follows:

   9.3.1.         Dr Brian Fisher declared an interest as co-director of PAERS Ltd,
                  enabling patients to see their GP records online, which may be linked
                  with Map of Medicine in the future.

   9.3.2.         Professor David Haslam declared an interest as being employed by
                  NICE to Chair the NHS Evidence Advisory Committee.

   9.3.3.         Dr Monika Lakhanpaul declared an interest as a member of The
                  Royal College of Paediatrics and Child Health clinical standards
                  committee, a board member of the National Collaborating Centre for
                  Women's Children's Health, and as a NICE clinical fellow.

   9.3.4.         Professor Stuart Logan declared an interest, as the Peninsula College
                  of Medicine and Dentistry receives funds from NICE for Health
                  Technology Assessments (HTAs).

   9.3.5.         Professor Jon Nicholl declared an interest as the School of Health
                  and Related Research (ScHARR), receives money from NICE for the
                  public health National Collaborating Centre.

   9.3.6.         Dr Carl Parker declared an interest as an employee of NHS Tees
                  Primary Care Trust, which is an early adopter site for Map of
                  Medicine.

9.4.        The Chair asked all NICE Staff to declare any relevant interests.

   9.4.1.         All NICE staff declared no interests, with the following exceptions:



                                                                        Page 5 of 14
         9.4.2.         Dr Paul Chrisp declared an interest as an internal reviewer for the
                        Royal College of Physicians: National Clinical Guideline for Stroke
                        (RCP NCGS), National Patient Safety Agency: Rapid Response
                        Reports (NPSA RRR), Royal College of Radiologists: Referral
                        Guidelines (RCR RG), Map of Medicine (MOM), and Medicines and
                        Healthcare products Regulatory Agency: Quality of Medicines (MHRA
                        QOM) accreditation submissions.

         9.4.3.         Ms Stephanie Birtles declared an interest as a technical analyst for
                        the Royal College of Physicians: National Clinical Guideline for Stroke
                        (RCP NCGS), National Patient Safety Agency: Rapid Response
                        Reports (NPSA RRR), Royal College of Radiologists: Referral
                        Guidelines (RCR RG), Map of Medicine (MOM), and Medicines and
                        Healthcare products Regulatory Agency: Quality of Medicines (MHRA
                        QOM) accreditation submissions.

10.     The Chair led the draft accreditation decision making session for the Royal College of
        Physicians: National Clinical Guideline for Stroke (RCP NCGS).

      10.1.       The committee discussed the RCP NCGS application summarised in the
                  NHS Evidence Advisory Committee submission report, based on the
                  accreditation overview, the external adviser reports and feedback from the
                  guidance   producer,    taking   into   account   the     weight   of   process
                  documentation, key criteria, and implementation of the process.

      10.2.       The Chair emphasised that any accreditation recommendation will only
                  apply to the guidelines produced following this process

      10.3.       There was discussion around the issues of accrediting a process with only
                  one product. The committee said this may set a precedent of accrediting
                  individual guidelines, with ramifications for workload and questioned how this
                  would affect the user experience.

      10.4.       In response, the NHS Evidence team confirmed that it is the process being
                  accredited, not the individual guideline, and that any other guidelines
                  produced using the same process would be eligible for accreditation. This is
                  the case for other guidance producers who may produce a range of

                                                                               Page 6 of 14
                 guidance using the same process. However in this instance the process is
                 unique to this particular guideline from this guidance producer.

      10.5.      The Chair confirmed that it is not the remit of the committee to make
                 recommendations      on    individual     guidance   products,     and      that   the
                 recommendation will be carefully worded to this effect, indicating that it is the
                 unique process used to develop this guideline that is subject to accreditation.

      10.6.      Following discussion and voting, the Chair announced that having read the
                 evidence and considered the issues that arose during the discussion, the
                 committee has come to the following conclusions which will be formulated
                 into the committee’s recommendations to NHS Evidence and NICE: the
                 Royal College of Physicians: National Clinical Guideline for Stroke is
                 recommended for draft accreditation by the NHS Evidence Advisory
                 Committee. The draft accreditation report will be published for public
                 consultation following review and approval at the NHS Evidence Publications
                 Executive, with the final accreditation decision made at the next available
                 committee meeting.

11.     The Chair led the draft accreditation decision making session for the National Patient
        Safety Agency: Rapid Response Reports (NPSA RRR).

      11.1.      The committee discussed the NPSA RRR application summarised in the
                 NHS Evidence Advisory Committee submission report, based on the
                 accreditation overview, the external adviser reports and feedback from the
                 guidance    producer,     taking   into    account   the   weight      of    process
                 documentation, key criteria, and implementation of the process.

      11.2.      There was discussion around the unmet criterion 6.3, relating to a lack of
                 process for handling conflicts of interest. The committee agreed this was
                 particularly important given the commercial significance of the RRRs and the
                 stakeholders involved.

      11.3.      The NHS Evidence team stated that the NPSA agreed with this finding, and
                 in response developed a draft process to handle conflicts of interest, to be
                 taken to the NPSA senior management. Subject to approval, all RRRs



                                                                                  Page 7 of 14
                 produced from this point will be developed according to this new process.

      11.4.      The committee recognised this is a good example of NHS Evidence helping
                 to raise standards in guidance production since the guidance producer is
                 changing its process with immediate effect.

      11.5.      While recognising that the guidance producer has taken immediate remedial
                 action, the committee was reminded that the process under consideration
                 does not currently include this step for handling conflicts of interest,
                 identified as a serious omission. Because conflict of interest is so important,
                 and the guidance producer had submitted evidence of a draft process to
                 address this criterion, confirmation of its immediate implementation is
                 necessary before the draft accreditation decision is made.

      11.6.      The Chair advised that the option of requesting further information would be
                 available, allowing the guidance producer to submit evidence supporting the
                 adoption and immediate implementation of its conflicts of interest policy.

      11.7.      Following discussion and voting, the Chair announced that having read the
                 evidence and considered the issues that arose during the discussion, the
                 committee has voted to request further information from the NPSA before a
                 draft decision can be made. This request will be relayed to the guidance
                 producer, with a draft decision made at the next available committee
                 meeting pending receipt of this information.

12.     The Chair led the draft accreditation decision making session for the Royal College of
        Radiologists: Referral Guidelines (RCR RG).

      12.1.      The committee discussed the RCR RG application summarised in the NHS
                 Evidence Advisory Committee submission report, based on the accreditation
                 overview, the external adviser reports and feedback from the guidance
                 producer, taking into account the weight of process documentation, key
                 criteria, and implementation of the process.

      12.2.      There was discussion around the uncertainty identified in criterion 5.2,
                 covering financial and organisational barriers to implementation. The
                 committee stated this was important to consider in this area.


                                                                              Page 8 of 14
      12.3.      It was noted that the guidance producer did provide an overview of how it
                 investigates financial barriers.

      12.4.      A suggestion was made for the guidance producer to provide broad
                 guidance on the relative costs of differing radiological options that would
                 help users to choose the most cost effective option.

      12.5.      The issue of accrediting individual guidance products was raised again, as
                 the committee noted the process used to produce the RCR RGs is only used
                 for that product. The NHS Evidence team explained that the guidance
                 product is a collection of individual guidelines across multiple areas that are
                 produced using this process.

      12.6.      Following discussion and voting, the Chair announced that having read the
                 evidence and considered the issues that arose during the discussion, the
                 committee has come to the following conclusions which will be formulated
                 into the committee’s recommendations to NHS Evidence and NICE: the
                 Royal College of Radiologists: Referral Guidelines are recommended for
                 draft accreditation by the NHS Evidence Advisory Committee. The draft
                 accreditation report will be published for public consultation following review
                 and approval at the NHS Evidence Publications Executive, with the final
                 accreditation decision made at the next available committee meeting.

13.     The Chair led the draft accreditation decision making session for the Map of Medicine
        (MOM).

      13.1.      The committee discussed the MOM application summarised in the NHS
                 Evidence Advisory Committee submission report, based on the accreditation
                 overview, the external adviser reports and feedback from the guidance
                 producer, taking into account the weight of process documentation, key
                 criteria, and implementation of the process.

      13.2.      The Chair advised that due to previously identified conflicts of interest, Dr
                 Carl Parker and Dr Brian Fisher would be unable to vote on this submission.

      13.3.      There was discussion around the suitability of the existing accreditation
                 criteria for assessing the MOM submission, given the type of guidance


                                                                             Page 9 of 14
                 product. The current criteria may not identify other critical issues in the
                 guidance production process.

      13.4.      Concern was raised as grey literature and guidelines of unknown quality can
                 be incorporated into the MOM end product.

      13.5.      The issue of lack of patient involvement, with no mention of patient choice
                 and preference, was noted.

      13.6.      Potential problems were identified with the local tailoring of national
                 guidance in the form of pathways.

      13.7.      There was debate about whether, given the great variation in local
                 pathways, an accreditation decision would help to bring about a unified
                 process, or whether accrediting a process that allows flexibility and may be
                 based on guidelines of unknown quality could be detrimental to patient
                 outcomes. Conversely, accrediting pathways that did not allow flexibility was
                 considered to be equally problematic.

      13.8.      It was agreed that there is a real need to help commissioners with this type
                 of information, but the appropriateness of the current accreditation tool, and
                 the feasibility of developing one for such a complex problem, was
                 questioned.

      13.9.      The Chair advised that the option of ‘inappropriate NHS Evidence
                 methodology’ would be available in this vote.




      13.10.     Following discussion and voting, the Chair announced that having read the
                 evidence and considered the issues that arose during the discussion, the
                 committee has come to the following conclusions which will be formulated
                 into the committee’s recommendations to NHS Evidence and NICE: the Map
                 of Medicine submission cannot be adequately assessed for NHS Evidence
                 Accreditation using the current criteria.

14.     The Chair led the draft accreditation decision making session for the Medicines and
        Healthcare products Regulatory Agency: Quality of Medicines (MHRA QOM)


                                                                            Page 10 of 14
  resubmission.

14.1.        The committee stated they understood the commercially sensitive nature of
             the information provided by the pharmaceutical industry, and the need for
             confidentiality on the MHRA’s part. Despite this, concerns were raised on
             two points:

   14.1.1.          Firstly, the completeness of information made available to the MHRA
                    by the pharmaceutical industry, and the lack of a process step to
                    cross-reference this against the body of available evidence, for
                    example by checking open access clinical trials registers.

   14.1.2.          Secondly, external scrutiny of the method by which this information is
                    assessed.

14.2.        It emerged in the course of the discussion that the MHRA may use an
             independent advisory committee and external advisers to assess the
             information made available to it, although full details were not provided by
             the guidance producer in its accreditation application or feedback. The
             committee was uncertain as to the function of, and the relationship with, the
             Commission on Human Medicines in the production of the MHRA QOM
             reports.

14.3.        It was felt that greater clarification on the above points may be required to
             reach a decision.

14.4.        The Chair advised that the option of requesting further information would be
             available in this vote.

14.5.        Following discussion and voting, the Chair announced that having read the
             evidence and considered the issues that arose during the discussion, the
             committee has voted to request further information from the MHRA before a
             draft decision can be made. To ensure all points requiring clarification are
             fully captured, it was agreed that the NHS Evidence accreditation team will
             draft details of the specific issues identified and circulate this to the
             Committee for approval. This request will then be relayed to the guidance
             producer, with a draft decision made at the next available committee


                                                                        Page 11 of 14
                   meeting pending receipt of the requested information.

15.     There was a break for lunch.

16.     The Chair welcomed Dr Paul Chrisp who led a session on contributing to the
        development of NHS Evidence, reviewing site statistics, the pattern of committee
        decisions, and the impact of the accreditation programme. The key points included:

      16.1.        The geography of site visitors (UK or international) and the most frequent
                   search terms remained similar through the last quarter. The latter provides a
                   useful insight into where to target the efforts of the accreditation programme.

      16.2.        Most users of NHS Evidence are healthcare professionals.

         16.2.1.          More detailed market analysis was requested, to further define the
                          current NHS Evidence audience.

      16.3.        Regarding the committee’s decisions from June 2009 to January 2010, 13
                   draft decisions and 9 final decisions have been made.

      16.4.        It was noted that proportionally the greatest uncertainty in compliance with
                   accreditation criteria has been in Domain 5, Applicability and Domain 3,
                   Rigour of development, although this uncertainty has been largely tolerated,
                   on a case-by-case basis.

      16.5.        To date, guidance producers with uncertainty in Domain 1, Scope and
                   purpose, and criterion 3.3, Assessing the strengths and weaknesses of the
                   evidence, have not been recommended for accreditation.

      16.6.        To date, no guidance producer with an unmet criterion has been
                   recommended for accreditation.

      16.7.        Analysis suggests 80% of guidelines on NHS Evidence are produced by
                   about 20% of producers. The present strategy has been to target these
                   producers in order to assess the greatest volume of guidance in the shortest
                   space of time. The committee broadly agreed with this approach, but there
                   was a note of caution not to ignore smaller producers of guidance for rare
                   conditions, who could benefit substantially from the programme. NHS


                                                                                Page 12 of 14
                 Evidence responded that they would consider this gap going forwards.

      16.8.      Accredited guidance will also support NICE quality standards and proposed
                 Quality and Outcomes Framework (QOF) topics.

      16.9.      Feedback from guidance producers demonstrates the accreditation scheme
                 has resulted in process changes to improve guidance production in many
                 areas.

      16.10.     It was requested that a summary of this information be made available to
                 new members of the Advisory Committee, and to guidance producers
                 wishing to embark on the accreditation scheme.

      16.11.     Developing a more commercially focussed business plan, informed by
                 greater user research, was discussed.

      16.12.     It was suggested that NHS Evidence could offer free workshops to smaller
                 guidance producers, in accordance with its role as an enabler of improved
                 standards.

      16.13.     The risks to reputation of offering a commercial services, particularly around
                 accreditation, were discussed.

17.     The committee were asked to review the revised process for providing feedback to
        guidance producers, as requested at the 20 January 2010 committee, and described
        in the accompanying paper.

      17.1.      The committee agreed the revised process addressed concerns raised at
                 the last meeting.

      17.2.      The committee asked what the response had been from guidance
                 producers. NHS Evidence replied to trial the proposed process with
                 guidance producers following committee approval.

      17.3.      The committee agreed with the proposed changes and the revised process
                 was approved.

18.     Paul Chrisp led a discussion around the accreditation of the National Collaborating
        Centres. The key points of this discussion included:

                                                                            Page 13 of 14
      18.1.      The committee was requested to consider whether, since the NCCs are
                 contracted by NICE to develop clinical guidelines, and the NICE CCP
                 guidance production process has been accredited by NHS Evidence, the
                 NCC full guidelines that follow this process are accredited.

      18.2.      The committee felt that although the process used by the NCCs to produce
                 the full guideline is included in the accredited process, the central issue was
                 one of quality assurance, to ensure that a contractor (in this case the NCC)
                 follows the agreed process (in this case that of the NICE CCP) correctly.

      18.3.      It was also recognised that this issue extends beyond NICE and the NCCs,
                 into several fields of guideline production where elements of work are
                 contracted out.

      18.4.      It was therefore suggested that a step for quality assurance needs to be
                 included in the guidance production process and subject to scrutiny by the in
                 the accreditation process.

      18.5.      The Chair requested an options paper outlining pros and cons and possible
                 unintended consequences to be presented to the committee.

Any Other Business

19.     There was no further business to discuss.

20.     The Chair thanked the public attendees, committee members and NICE staff
        members for their attendance, participation and contribution to the meeting.

Date, time and venue of the next meeting

21.     Wednesday 28th April 2010, 10.30am – 4pm
        The Derwent, National Institute for Health and Clinical Excellence
        MidCity Place | 71 High Holborn | London WC1V 6NA




Closed session




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