A National Clinical Practice Guidelines Programme

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

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

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

4. Scotland

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. Scottish Parliament established 1999 designed by Enric Miralles Context

8. 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 and the NHS?

9. Scotland Area = 78,080 km2 Population  5.1 million Population density  66 per km2 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 km2 Population  40.49 million Population density  87.8 per km2 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 • Rationale • Structure/Organisation • Politics • Measuring success

13. Why a national programme? • Why guidelines? • Why national?

14. 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 Why guidelines?

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)

17. Prove it

18. 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 - 298,000 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 Why national?

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 thereis 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 SIGNScotland’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/Organisation • Politics • Measuring success

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

28. Governance SIGN Council 48 representatives • Strategic decision making • Direction/goals • Where will this responsibility lie? 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 Executive Programme Management Team Research and Information Team Administration and Networking Guideline development groups Antibiotic prophylaxis SIGN Council 40 representatives ASD Gastric Cancer CHD Cervical Cancer Meningococcal disease Adult Headache bronchiolitis Bacterial UTI Bladder cancer Upper GI blood loss Hepatitis C dementia stroke

41. 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 pros & cons

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 • 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? • 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 • A summary of the clinical problems and outcomes to be addressed. • Details of the group(s) or institution(s) supporting the proposal. • A brief background to the clinical topic which will be addressed by the proposed guideline. • Evidence of variation in practice in the management of the condition. • An indication of the benefits likely to arise from the development and successful implementation of the guideline. • A definition of the patient group to which the guideline will apply. • 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. • An indication of the health care professionals potentially involved in developing the guideline. • An indication of the size and strength of the evidence base which is available to support recommendations on effective practice, citing key supporting papers. • 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)