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A National Clinical Practice Guidelines Programme Safia Qureshi PhD, Programme Director, SIGN a Scottish Story.

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Presentation on theme: "A National Clinical Practice Guidelines Programme Safia Qureshi PhD, Programme Director, SIGN a Scottish Story."— Presentation transcript:

1 A National Clinical Practice Guidelines Programme Safia Qureshi PhD, Programme Director, SIGN a Scottish Story

2 History – Scotland, SIGN Rationale Structure/Organisation Politics Measuring success

3 History – Scotland, SIGNHistory – Scotland, SIGN Rationale Structure/Organisation Politics Measuring success

4 Scotland

5

6 Health care in the UK National Health Service (NHS) Established in 1948  the NHS provides comprehensive care  everyone in the UK has the right to use it  care is provided on the basis of clinical need – not on ability to pay

7 Context Scottish Parliament established 1999 designed by Enric Miralles

8 and the NHS? Scotland Scottish Parliament - devolved responsibilities include health NHS in Scotland –15 Health Boards – large/small, rural/urban England & Wales Department of Health responsible for England –28 NHS strategic Health Authorities Welsh Assembly –22 Local Health Boards

9 Scotland Area = 78,080 km 2 Population  5.1 million Population density  66 per km 2 Principle of NHS – free for all with equity of access Infant mortality 5.1 /1000 live births Life expectancy 78.5 years 16% of the population is over 65 years old EIU QoL index - 29 Spain Area = 499,542 km 2 Population  million Population density  87.8 per km 2 Principle of NHS – available to all and free at the point of service Infant mortality 4.4 /1000 live births Life expectancy 79.7 years 17.7% of the population is over 65 years old EIU QoL index - 10

10 Introducing SIGN (1) SIGN was set up in 1993 by the Medical Royal Colleges and faculties Since January 2005 part of the NHS in Scotland (as part of a special health board called NHS Quality Improvement Scotland or NHS QIS)

11 Introducing SIGN (2) Wholly publicly funded – part of NHS Scotland Independent of political and pharmaceutical industry influence Policy and programme determined by an independent board known as SIGN Council

12 History – Scotland, SIGN RationaleRationale Structure/Organisation Politics Measuring success

13 Why a national programme? Why guidelines? Why national?

14 Why guidelines?  promote EBM -clinical decisions should be based on results of high quality clinical trials/observational studies assist practitioner and patient decisions –about appropriate healthcare for specific clinical circumstances -easily accessible –summary & evaluation the ever-increasing amounts of current evidence –best practice in other specialty areas  address growing concern about variation in clinical practice  economic crisis in Western health care -focus on cost containment

15 Evidence based medicine…. the "integration of best research evidence with clinical expertise and patient values” David Sackett, et al. Evidence-Based Medicine: How to Practice and Teach EBM (New York: Churchill Livingstone, 2000)

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17 Prove it

18 Why national?  set national standards -evidence based approach -address variation in practice on a national scale -promote equity of access/reduce postcode prescribing  control resource use - developing a guideline is resource intensive – time, money, manpower (100, ,000 Euros for SIGN. 4,000 – 447, 000 Euros CoCan)  extra-professional interest in CPGs - purchasers (governments, insurance companies) and patients clarity for policymakers/providers –so they know which guideline to follow

19 National vs. local guidelines The problem: Guidelines are most likely to be scientifically valid if they are developed by a national group representing all key disciplines but more likely to be valued and thus effective in changing medical practice if there is local involvement in their development and local ownership over the implementation process

20 National vs. local guidelines The Scottish solution: SIGN develops national guidelines to a standard methodology to maximise validity

21 National vs. local guidelines The Scottish solution: SIGN develops national guidelines to a standard methodology to maximise validity The national guideline is then critically reviewed and adapted at a local level for local implementation

22 Birth of SIGN Scotland’s traditions – and health Small, but proud and independent Respect for education, science, equity 4 University/Medical Schools and 3 Royal Colleges by 1700 Scottish Enlightenment (late 1700s) 1753 – controlled trial of limes in scurvy (James Lind, Treasurer RCPE) scientific/critical approach to healthcare (McKenzie, Cochrane, Chalmers)

23 Positive environment for a national guidelines initiative A clinical champion – Professor Jim Petrie –“we need a charismatic leader to convince his or her colleagues to take action—the equivalent of a medical Nelson Mandela. But Mandelas are short on the ground politically and medically. Jim Petrie, president of the Edinburgh College of Physicians, was one such Mandela”.

24 Objectives of SIGN to sponsor and support the development of evidence-based national clinical guidelines and to facilitate their implementation into local practice for the benefit of patients.

25 Principles of SIGN Publicly-funded (NHSScotland) Professionally-led (SIGN Council) Professionally-developed (SIGN Executive – CPG experts) Independent of politicians and industry

26 History – Scotland, SIGN Rationale Structure/OrganisationStructure/Organisation Politics Measuring success

27 What does a national programme look like? Governance Principles Systems/methodology Staffing

28 Governance Strategic decision making Direction/goals Where will this responsibility lie? SIGN Council 48 representatives SIGN Council is a Network of 45+ representatives from: Medical Royal Colleges Dentistry Nursing Pharmacy Professions Allied to Medicine Public Health Patients

29 Terms of reference for SIGN Council consider proposals for new and review guideline topics & advise if these should be accepted into the SIGN Programme ensure that all relevant specialities are represented on guideline development groups or consulted as appropriate monitor progress with the SIGN guideline development and review programme consider and approve proposals for changes to SIGN methodology, processes, or activities provide a forum for sharing information about guideline development, dissemination, implementation and related activities.

30 …since transfer to NHS In January 2005 SIGN became part of the NHS principles protected: –multi-professional involvement –SIGN Council determining programme –editorial freedom

31 Principles guidelines are evidence based and produced using a transparent, rigorous and robust methodology that can be shown to adhere to internationally recognised standards for guideline development guideline topics can be proposed by any professional body or group of individuals with an interest in health care in Scotland SIGN process is consultative and multidisciplinary (including patients)

32 Systems/methodology How will you develop your guidelines? Evidence based? Standard methodology? Grading system? –no/yes? –which one? Cost-effectiveness? –When? –How? Who will develop your guidelines? Professional staff? Clinical staff? –paid/volunteers?

33 Systems/methodology How will you develop your guidelines? Evidence based? - yes Standard methodology? – yes, defined in a technical manual Grading system? –no/yes? –which one? Cost-effectiveness? –When? –How? Who will develop your guidelines? Professional staff? Clinical staff? –paid/volunteers?

34 Systems/methodology How will you develop your guidelines? Evidence based? - yes Standard methodology? – yes, defined in a technical manual Grading system? –no/yes? - yes –which one? – developed by SIGN, based on AHCPR 1993 (AHRQ) Cost-effectiveness? –When? –How? Who will develop your guidelines? Professional staff? Clinical staff? –paid/volunteers?

35 Systems/methodology How will you develop your guidelines? Evidence based? - yes Standard methodology? – yes, defined in a technical manual Grading system? –no/yes? - yes –which one? – developed by SIGN, based on AHCPR 1993 (AHRQ) Cost-effectiveness? –When? –after clinical recommendation made –How? – by looking at resource implications of key recommendations Who will develop your guidelines? Professional staff? Clinical staff? –paid/volunteers?

36 Systems/methodology How will you develop your guidelines? Evidence based? - yes Standard methodology? – yes, defined in a technical manual Grading system? –no/yes? - yes –which one? – developed by SIGN, based on AHCPR 1993 (AHRQ) Cost-effectiveness? –When? –after clinical recommendation made –How? – by looking at resource implications of key recommendations Who will develop your guidelines? Professional staff? – to facilitate process Clinical staff? –appraise evidence, make recommendations –paid/volunteers? – voluntary, time given by agreement with NHS

37 Is it wise to leave costs out?

38 Structure & staffing SIGN Council – direction, policy SIGN Executive – professional support –administration –project management –information skills –editorial skills –people skills SIGN guideline development groups – clinical expertise

39 SIGN Council 40 representatives Guideline development groups SIGN Executive Administration and Networking Programme Management Team Research and Information Team Upper GI blood loss Bladder cancer stroke Bacterial UTI dementi a Hepatitis C bronchioliti s CHD Gastric Cancer Adult Headache Cervical Cancer ASD Antibiotic prophylaxis Meningococcal disease

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41 pros & cons Evidence is read, interpreted, applied by clinicians Recommendations made by clinicians for clinicians Fixed development system allows project management “SIGN” is an external entity – neutral Professional staff promote team building, get things done Huge commitment required from clinicians, managers etc Timescales have to be flexible Timescales are long Training/support element is labour intensive

42 Selection of topics  Who could select?  Guideline development agency  Government  Insurance agencies  Healthcare professionals  Patients

43 SIGN 3-stage process  Topic gathering  Topic selection  Topic prioritisation

44 Stage 1 - Topic gathering  Specialty subgroups (cancer, mental health, women and children, primary care, general medicine, surgery) generate topics by consultation with healthcare professionals  Topics accepted from any interested party living in Scotland

45 Introducing proposals A guideline proposal should contain enough information to allow the guideline developer to understand the rationale and remit of the proposed topic SIGN uses 2 proposal forms – an outline proposal form and a full proposal form

46 Stage 2 - Selection of topics Existence of variation in practice Evidence of effective practice Burden of disease Priority area for NHS in Scotland - cardiovascular disease, cancer, mental health, primary care, child health

47 Selection process 1.Is this an appropriate clinical topic for a SIGN guideline? - is the topic clinical, what is its breadth and has the need for the guideline been identified in the proposal? 2.Is there a suitable alternative product which would address this topic? - could other NHS products better address the topic? 3.Has this topic been considered before and rejected? The reasons for rejection would be reviewed and reassessed.

48 Results of topic selection  Go forward to the next stage of topic selection - generate full proposal  Recommend to other parts of NHS QIS for consideration for a standards, best practice statement, evidence notes, HTA etc  Throw out.

49 Full proposal form 1.A summary of the clinical problems and outcomes to be addressed. 2.Details of the group(s) or institution(s) supporting the proposal. 3.A brief background to the clinical topic which will be addressed by the proposed guideline. 4.Evidence of variation in practice in the management of the condition. 5.An indication of the benefits likely to arise from the development and successful implementation of the guideline. 6.A definition of the patient group to which the guideline will apply. 7.A definition of the aspects of management of the clinical condition which the proposed guideline will address and an indication as to whether the guideline will apply to primary or secondary care, or both. 8.An indication of the health care professionals potentially involved in developing the guideline. 9.An indication of the size and strength of the evidence base which is available to support recommendations on effective practice, citing key supporting papers. 10.Details of any existing guidelines or systematic reviews in the field.

50 Stage 3 – Prioritisation of topics  Several suitable topics have been identified, selected and approved  Resources are limited, so topics must be prioritised to arrive at final work programme  How many depends on resources (human, financial, time)

51 Prioritisation Tool Developed by a subgroup of SIGN Council PROPOSAL TITLE: Scoring 1 Is this an important topic?5 (high) - 1 (low) 0 (DK) * From the clinical perspective * From identified patient issues (as per proposal form) * Burden of disease perspective (as per proposal form) 2 Is there evidence of variation in practice and outcomes? 5 (very high) 1 (negligible) 0 DK * What is the size of the variation 3 Is there sufficient high quality evidence (defined here as systematic reviews or RCTs) on which to base a guideline? 5 (very large) - 1 (small) 0 DK * How substantial is this? 4 Is there explicit support for the guideline from a network of relevant stakeholders (as per proposal from) 1=yes, no=0, DK=0 5 Is there potential for a guideline to have an impact on variation in practice? 1=yes, no=0, DK=0 TOTAL

52 Defining the scope Who should do this?  Individual (Chairperson, Director, Proposer)?  Guideline development agency?  Guideline group?  Government?  Target audience?

53  Individual (Chairperson, Director, Proposer)?  Guideline development agency?  Guideline group?  Government?  Target audience? Proposer helps to define scope by making proposal as detailed as possible Guideline agency sets criteria for what is and is not permitted in the guideline Guideline group will have the chance to alter remit when defining key questions Group membership National consultation

54 at the other side of the process.. Reviewing Methodology for review is the same as for development of a new guideline –Reviewing has the same resource requirement as developing a new guideline Reviews compete for limited programme space with new proposals –The status/relevance of guidelines that are past their review date may be questionable

55 Reviewing (updating) (1) At SIGN 32 (out of 92) guidelines are overdue for review Do we have an obligation to review? –all guidelines? –at a fixed interval? How long? –do we have to review a guideline in its entirety?

56 Reviewing (updating) (1) At SIGN 32 (out of 92) guidelines are overdue for review Do we have an obligation to review? –all guidelines? yes –at a fixed interval? How long? –do we have to review a guideline in its entirety?

57 Reviewing (updating) (1) At SIGN 32 (out of 92) guidelines are overdue for review Do we have an obligation to review? –all guidelines? yes –at a fixed interval? How long? every 3 years –do we have to review a guideline in its entirety?

58 Reviewing (updating) (1) At SIGN 32 (out of 92) guidelines are overdue for review Do we have an obligation to review? –all guidelines? yes –at a fixed interval? How long? every 3 years –do we have to review a guideline in its entirety? yes

59 Reviewing (updating) (2) Unsustainable with current resources – new approach suggested: provide a process where a guideline coming up for review can either be: –revalidated for a further year –subject to complete review. –subject to selective review –withdrawn

60 New updating process (1) SIGN will carry out an update search: evidence-based guidelines, HTAs, systematic reviews produced since publication of the last version of a guideline. searches will be based on the key questions and search strategies used in the original guideline include an element of horizon scanning to see if there are any new questions that should be considered

61 New updating process (2) SIGN Executive will use these search results to produce a review report that : summarises the latest research notes how it compares with recommendations in the guideline Includes any new developments that might require additional questions to be addressed

62 New updating process (3) Consultation – the review report will be circulated for comment SIGN executive will make recommendations to SIGN Council on which guidelines should be reviewed, and what type of review is appropriate development time estimated at around 15 months, compared with the current target of 30 months for a full guideline.

63 History – Scotland, SIGN Rationale Structure/Organisation PoliticsPolitics Measuring success

64 Guidelines in the Scottish context Guidelines are part of a range of complementary activities in the National Health Service in Scotland to promote clinical excellence

65 Status of SIGN guidelines Not mandatory (NICE guidelines are in E&W) There is no compulsion to implement any SIGN guideline or individual recommendation

66 Status of SIGN guidelines Not mandatory (NICE guidelines are in E&W) There is no compulsion to implement any SIGN guideline or individual recommendation … but Health Boards, NHS Trusts, clinical teams and individual practitioners should be able to define the standard of care which they provide

67 Status of SIGN guidelines Not mandatory (NICE guidelines are in E&W) There is no compulsion to implement any SIGN guideline or individual recommendation … but Health Boards, NHS Trusts, clinical teams and individual practitioners should be able to define the standard of care which they provide…. … and to justify if necessary why this does not meet nationally agreed recommendations

68 Main pressures on SIGN (1) To agree with other arms of QIS –Scottish medicines consortium provides advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) about the status of all newly licensed medicines, all new formulations of existing medicines –QIS assessments of NICE MTAs which are mandatory To take on board what NICE are saying/doing –programme –publications –recommendations

69 Main pressures on SIGN (2) Pressure from patients minimal –are involved in guideline development and review –On SIGN Council –SIGN patient network facilitates communication –Defined methodology for involvement Pressure from pharmaceutical companies increasing –to allow register of stakeholders and submission of evidence –political environment against this at present

70 Main defences for SIGN The methodology –Well known, well respected, international standard Editorial freedom –preserved in transfer to NHS Clinical champions –SIGN Council, guideline development group members (over 2,000 clinicians) History –established position

71 History – Scotland, SIGN Rationale Structure/Organisation Politics Measuring successMeasuring success

72 Are we a success? Are the guidelines implemented? Have we changed practice? Secure funding stream Never needed to make a formal call for new proposals Publicity is positive Clinical commitment is still there Reputation still good

73 Have we changed practice? Prophylaxis of deep vein thrombosis Inverclyde Royal Hospital  “At risk” patients prescribed prophylaxis increased from 72.8% to 97.4%  Use of correct prophylaxis increased from 54.5% to 95.9%

74 Have we changed practice? Chlamydia trachomatis infection Lothian Primary Care Trust  audit in Springwell Medical Centre showed increase in appropriate screening for chlamydial infection from 65% to 94% after training following the guideline recommendations

75 Positive press?

76 History – Scotland, SIGN Rationale Structure/Organisation Politics Measuring success ConclusionsConclusions

77 My conclusions A successful national guidelines programme needs: a charismatic clinical champion in the early days to have a clear remit and principles by which it will work to consistently follow a standard, internationally accredited methodology to have a defined and transparent role with government – responsibilities clear on each side to have a defined and transparent role with industry to have editorial independence to be inclusive, open Audit what you do and what your guidelines do Don’t forget about implementation

78 Final thoughts The only dictator should be the evidence Employ evangelists! –believers will spread the word

79 Thank you


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