Evidence in action

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Evidence in action moving from guidance to
review

• Sophie Robinson, Toni Price, Caroline Miller
• National Institute for Health and Clinical
  Excellence (NICE)
• Health Libraries Group conference July 2010

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What were going to talk about

• Role of information specialists in producing and
  reviewing NICE technology appraisals
• how information specialists are involved in the
  scoping and review processes
• information gathered by information specialists
• Skills challenges involved in supporting
  technology appraisals

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What is NICE?

• The National Institute for Health and Clinical
  Excellence (NICE) is the independent organisation
  set up in 1999 based in England responsible for
• providing national guidance on the promotion of
  good health and the prevention and treatment of
  ill health
• setting quality standards
• managing NHS Evidence
• NICE makes recommendations to the NHS on
• new and existing medicines, treatments and
  procedures
• treating and caring for people with specific
  diseases and conditions.
• NICE makes recommendations to the NHS, local
  authorities and other organisations on
• how to improve peoples health and prevent
  illness and disease.

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The information services team at NICE

• A team of 20 information professionals based in
  London and Manchester
• Provide information support to meet the
  information needs of NICE staff and to help
  produce NICE guidance
• Support topic selection, appraisals scoping
  reviews, short guidelines, interventional
  procedures, quality standards, quality outcomes
  framework, devices diagnostics, public health,
  NICE taxonomy etc
• Liaison leads for all teams in Institute
• Library resources journals, databases, books,
  ILLs, information skills training, current
  awareness service

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What is a technology appraisal?

• Technology appraisals are recommendations on the
  use of new and existing medicines and treatments
  within the NHS, such as
• medicines
• medical devices (for example, hearing aids or
  inhalers)
• diagnostic techniques (tests used to identify
  diseases)
• surgical procedures (such as repairing hernias)
• health promotion activities (for example, ways of
  helping people with diabetes manage their
  condition).

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Types of appraisal

• Single technology appraisals (STA) specifically
  designed for the appraisal of a single product,
  device or other technology with a single
  indication where most of the relevant evidence
  lies with one manufacturer
• eg Everolimus for the prevention of organ
  rejection in kidney transplantation (in progress)
• Multiple technology appraisal (MTA) - includes
  more than one product, device or technology or
  more than one indication or more than one
  manufacturer or sponsor
• eg Immunosuppressive therapy (basiliximab,
  daclizumab, tacrolimus, mycophenolate (mofetil
  and sodium) and sirolimus) for renal
  transplantation in children and adolescents TA99

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Technology appraisals

• Technology appraisal recommendations are based on
  a review of clinical and economic evidence.
• Clinical evidence measures how well the medicine
  or treatment works.
• Economic evidence measures how well the medicine
  or treatment works in relation to how much it
  costs the NHS - does it represent value for
  money?
• Independent academic assessment groups carry out
  the systematic review process for appraisals
• Obligation for NHS organisations to fund and
  resource medicines and treatments recommended,
  usually within three months of NICE issuing
  guidance

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The technology appraisal process
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The role of the information specialist in the
technology appraisal process

• Initial information support at topic selection
  stage support with identifying related guidance
  for briefing notes for topic selection
  consideration panels
• Support for production of draft scope 2-4
  page document setting out parameters of topic in
  question, used for consultation
• Collaborate with a technical analyst in
  production of draft scope and provide other
  information support needed throughout the
  production process
• Monitor topic right through to publication
  licensing updates and key new trials
• New topics and review topics are scoped

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Contributing to the draft scope

• Collate information on
• Health condition/disease/behaviour in question
• Population affected including epidemiological
  information, equality issues
• Technology in question including licensing
  information
• Evidence based guidance on health condition /
  technology
• Relevant key trials
• Not a systematic search at scoping stage
• Record information via NICE intranet on a
  scoping page which is updated

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Information specialist skills used in production
of technology appraisal

• Retrieval, interpretation, synthesis, summarising
  presenting information
• Elements of critical appraisal to summarise key
  evidence
• Collaborative with technical analyst
• Identifying issues for consideration - eg
  populations, comparators, links with other
  appraisals or NICE guidance

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Challenges of contributing to the scoping process

• Risk of working in advance of licensing and
  topics not coming to fruition
• Uncertainty around licensing requires updates to
  information
• Project management timelines
• Understanding diseases, stages, lines of
  treatment
• Identifying relevant key trials
• Identifying key issues eg whether an appraisal is
  feasible (fallers clinics where no definition or
  evidence and topic did not progress)
• Knowing when to stop searching for information

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Reviewing Technology Appraisals

• All published technology appraisal guidance is
  given a date (between 1-5 years) at which the
  guidance will be considered for review.
• These reviews are known as Review Proposal
  Projects or RPPs.
• The aim of the review process is to decide
  whether or not the guidance needs to be updated.
• Information services play a central role, by
  providing an evidence base upon which to make the
  decision.

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RPP process overview
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Information Services involvement

• IS staff carry out the bulk of the work for
  development of RPPs, gathering and evaluating
  information to see if there is significant
  evidence to warrant a review.
• This involves literature searching and writing
  recommendation papers for NICEs Guidance
  Executive (senior management team) to consider.
• The information specialist has to work to
  specific timelines and processes developed and
  overseen by a Project Manager from Technology
  Appraisals.

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Information gathering

• The information specialist will familiarise
  themselves thoroughly with the appraisal to be
  reviewed, with the disease area concerned and
  with the drug or device.
• They will also search for new evidence including
• New indications for drugs included in the
  original guidance and related new products.
• Information on the progress of ongoing randomised
  controlled trials.
• Update to the searches used in the original
  Health Technology Assessment report for the
  appraisal.

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Results

• The results of the searches are sifted by the
  information specialist to identify any new
  evidence that could trigger a review of the
  appraisal.
• For example, the IS may find a key clinical trial
  that could lead to the deferral of the review of
  the appraisal awaiting trial results.
• The published results of an RCT may contradict
  one of the recommendations in the original
  appraisal.
• A new indication or new related drug may mean the
  information in the appraisal is out of date.

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Proposal paper for Guidance Executive (GE)

• Aims to summarise and collate relevant
  information found in a report template, which is
  presented to NICEs senior management team.
• Recommends a proposal for what should happen to
  the appraisal (one from a list of standard
  options).
• A technical analyst will analyse and report on
  the results of the searches and make the final
  decision on the recommendation in conjunction
  with colleagues.

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Possible recommendations

• Review of the appraisal should be
• planned into the appraisal work programme
• decision to review will be deferred until X (for
  example, to await the results of a key clinical
  trial)
• combined with the review of a related technology
  appraisal or with a related new topic referred to
  NICE
• incorporated or updated into an on-going clinical
  guideline
• transferred to static guidance list.

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Proposal paper for Guidance Executive

• The paper is agreed by an Associate Director from
  the appraisals team.
• The paper is then submitted to the senior
  management team (Guidance Executive) who consider
  the evidence and make the final proposal for the
  recommendation.
• NICE then consults on the proposal with
  consultees and commentators (manufacturers,
  patient groups, NHS Trusts, Royal Colleges and
  other interested parties).
• The proposal is posted on the NICE website.

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Decision paper for Guidance Executive

• At the end of the consultation period a summary
  of consultation responses is collated.
• This is compiled by the information specialist
  with input from the technical analyst and project
  manager where necessary.
• Comments from consultees are tabulated and
  responses are given.
• The paper is agreed by an Associate Director and
  then goes to GE for consideration.
• Consultees are advised of the final decision and
  this is also posted on the NICE website.

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Information Specialist work

• Timelines
• Reading and understanding the existing guidance
• Identifying the challenging areas for search
  purposes
• Searching
• Understanding the findings and the implications
• Communication with analyst in advance of
  presenting the findings
• Identifying the best recommendation, according to
  the findings

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Challenges of TA99

• Sifting for relevant information - how relevant
  might data on adults be?
• Choosing what to recommend as the way forward
  using and understanding the evidence base
• Information synthesis making a robust case for
  review
• Time not unlimited
• Transparency

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RPP skills

• Process driven work
• Searching finding the key information
• Judgement - understanding and interpreting the
  findings (for example whats pivotal, what will
  make a material difference to our existing
  guidance)
• Decision making based on the evidence make the
  proposal
• Project management, and being an active team
  player
• Communications skills

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Summary

• Information specialists use a wide range of
  skills when supporting the scoping process and
  the reviews of health technology appraisals
• Information services team do 3 RPPs and 7 scopes
  per month in addition to work for other
  Directorates at NICE
• Any questions?
• caroline.miller_at_nice.org.uk toni.price_at_nice.org.u
  k sophie.robinson_at_nice.org.uk
• www.nice.org.uk