Presentation on theme: "Evidence in action – moving from guidance to review"— Presentation transcript:
1Evidence in action – moving from guidance to review Sophie Robinson, Toni Price, Caroline MillerNational Institute for Health and Clinical Excellence (NICE)Health Libraries Group conference July 2010
2What we’re 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 processesinformation gathered by information specialistsSkills & challenges involved in supporting technology appraisals
3What is NICE?The National Institute for Health and Clinical Excellence (NICE) is the independent organisation set up in 1999 based in England responsible forproviding national guidance on the promotion of good health and the prevention and treatment of ill healthsetting quality standardsmanaging NHS EvidenceNICE makes recommendations to the NHS on:new and existing medicines, treatments and procedurestreating and caring for people with specific diseases and conditions.NICE makes recommendations to the NHS, local authorities and other organisations on:how to improve people’s health and prevent illness and disease.
4The information services team at NICE A team of 20 information professionals based in London and ManchesterProvide information support to meet the information needs of NICE staff and to help produce NICE guidanceSupport topic selection, appraisals scoping & reviews, short guidelines, interventional procedures, quality standards, quality & outcomes framework, devices & diagnostics, public health, NICE taxonomy etcLiaison leads for all teams in InstituteLibrary resources – journals, databases, books, ILLs, information skills training, current awareness service
5What is a technology appraisal? Technology appraisals are recommendations on the use of new and existing medicines and treatments within the NHS, such as:medicinesmedical 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).
6Types of appraisalSingle 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 manufacturereg 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 sponsoreg Immunosuppressive therapy (basiliximab, daclizumab, tacrolimus, mycophenolate (mofetil and sodium) and sirolimus) for renal transplantation in children and adolescents TA99
7Technology 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 appraisalsObligation for NHS organisations to fund and resource medicines and treatments recommended, usually within three months of NICE issuing guidance
8The technology appraisal process Scoping & question setting, consultationEvidence review and independent appraisalAppraisal committees and open consultationFinal conclusion, [opportunity for appeal] and publicationUpdate of appraisal
9The 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 panelsSupport for production of ‘draft scope’ – 2-4 page document setting out parameters of topic in question, used for consultationCollaborate with a technical analyst in production of draft scope and provide other information support needed throughout the production processMonitor topic right through to publication – licensing updates and key new trialsNew topics and review topics are ‘scoped’
10Contributing to the draft scope Collate information onHealth condition/disease/behaviour in questionPopulation affected including epidemiological information, equality issuesTechnology in question including licensing informationEvidence based guidance on health condition / technologyRelevant key trialsNot a systematic search at scoping stageRecord information via NICE intranet on a ‘scoping page’ which is updated
13Information specialist skills used in production of technology appraisal Retrieval, interpretation, synthesis, summarising & presenting informationElements of critical appraisal to summarise key evidenceCollaborative with technical analystIdentifying issues for consideration - eg populations, comparators, links with other appraisals or NICE guidance
14Challenges of contributing to the scoping process Risk of working in advance of licensing and topics not coming to fruitionUncertainty around licensing requires updates to informationProject management timelinesUnderstanding diseases, stages, lines of treatmentIdentifying relevant key trialsIdentifying key issues eg whether an appraisal is feasible (faller’s clinics where no definition or evidence and topic did not progress)Knowing when to stop searching for information
15Reviewing 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.
16RPP process overview Proposal options include: A Review Proposal consultation document is written by the Information Specialist lead with assistance of Technical LeadProposal options include:- Appraisal should be updated- Defer date for review- Incorporate in a clinical guideline- Transfer guidance to static list- Appraisal combined with a new appraisal that has recently been referredGuidance executive agrees the paper and the proposal is consulted on with the RPP consultees and commentatorsConsultation responses are reviewed and incorporated into a decision paperGE agrees the final decision and consultees and commentators are advisedDecision actioned
17Information 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 NICE’s 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.
18Information 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.
19ResultsThe 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.
20Proposal paper for Guidance Executive (GE) Aims to summarise and collate relevant information found in a report template, which is presented to NICE’s 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.
21Possible 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.
22Proposal 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.
23Decision 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.
26Information Specialist work TimelinesReading and understanding the existing guidanceIdentifying the challenging areas for search purposesSearchingUnderstanding the findings and the implicationsCommunication with analyst in advance of presenting the findingsIdentifying the best recommendation, according to the findings
34Challenges of TA99Sifting for relevant information - how relevant might data on adults be?Choosing what to recommend as the way forward – using and understanding the evidence baseInformation synthesis – making a robust case for reviewTime – not unlimitedTransparency
35RPP skills Process driven work Searching – finding the key information Judgement - understanding and interpreting the findings (for example what’s pivotal, what will make a material difference to our existing guidance)Decision making based on the evidence – make the proposalProject management, and being an active team playerCommunications skills
36SummaryInformation specialists use a wide range of skills when supporting the scoping process and the reviews of health technology appraisalsInformation services team do 3 RPPs and 7 scopes per month in addition to work for other Directorates at NICEAny questions?