The First International Congress on Prevention Diagnosis

The First International Congress on Prevention, Diagnosis & Management of Hypertension in Iran & Developing the Iranian Guideline Introducing the Process of Developing Guidelines on Hypertension Prevention, Treatment & Control in Iran Prof. Nizal Sarrafzadegan Isfahan Cardiovascular Research Institute WHO Collaborating Centre Isfahan, Iran September 27 -29, 2011 Isfahan, Iran 1

Iranian Guidelines on Hypertension (IGH) Iranian working Group Members: • Chairman: Prof. F. Noohi • Secretary General: Prof. N. Sarrafzadegan • Dr. E. Andalib • Prof. A. Khosravi • Dr. M. Ostovan • Dr. A. Moloudi • Dr. H. Arefi • Dr. S. Hajebrahimi • A. Rashidian • Dr. J. Zamani • Dr. L. Nosrati • Dr. E. Nematipour • Dr. A. Hosseine • • • • Dr. M. Hasanzadeh Dr. M. Ghabaee Dr. J. Najafian Dr. J. Golshahi Dr. A. Tavassoli Dr. A. Merrikhi Dr. M. Mortazavi Dr. M. Sadeghi Dr. M. Pourmoghadas Dr. Shirani Dr. B. Iraj Dr. B. Sarvar Azimzadeh Dr. A. Ossareh Mrs. N. Mohammadifard Mrs. M. Gharipour 2

Iranian Guidelines on Hypertension (IGH) International Advisory Board Members: • • • • Prof. N. Campbell, Canada Prof. Ch. Jones, Canada Prof. G. Fodor, Canada Prof. M. Lebel , Canada Dr. S. Stachenko, Canada Prof. R. Cífková, Czech Republic Prof. A. Jula, Finland Prof. D. G. Beveers, England Mr. L. M. Nherera, England Prof. Mohammad Ishaq, Pakistan Dr. A. Hayen, Australia Prof. R. Jackson, New Zealand Prof. K. A. Taubert, USA 3

What is evidence-based medicine (EBM)? “Evidence-based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. ” - David Sackett 4

Evidence-based medicine Evidence-based Medicine Gathering medical information Evaluating quality of medical information Making medical decisions using best evidence 5

Evidence-informed Practice “The conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients and involves integrating individual clinical expertise with the best available external evidence from systematic research. ” (Sackett, 1996) 6

Evidence-informed Decision-Making Adapted from Di. Censo & Cullum 1998 & Haynes et al. , 1996 Clinical expertise Research evidence Resources Patients’ preferences 7

What are Best Practice Guidelines (BPG)? “Systematically developed statements (based on best available evidence) to assist practitioner and patient decisions about appropriate health care for specific clinical (practice) circumstances” (Field & Lohr, 1990) 8

Comparing Standards of Practice to BPG Standard • Based on values, morals, legislation • Minimum requirements for individual practitioner • Basis for determining professional competence, misconduct & malpractice • Emphasis on legal & ethical requirements BPG • Based on evidence from a critical review of the literature • Suggested guidelines for individuals and organizations • Emphasis on synthesis of the literature 9

Types of Evidence? 10

Levels of Evidence Ia Meta-analysis or systematic review of randomized control trials Ib At least one randomized controlled trial IIa At least one well-designed controlled study without randomization. IIb At least one other type of well-designed quasi-exp. study without randomization III Well-designed non-exp. descriptive studies IV Expert committee reports or opinions and/or clinical experiences of respected authorities 11

Strength of evidence ratings for guideline recommendations • A = Strong research based evidence – multiple relevant, high quality studies • B = Moderate research based evidence – one relevant, high quality study • C = Limited research based evidence – one adequate study, somewhat relevant • D = Panel opinion – based on information not meeting criteria for A-C 12

Additional Sources of Evidence • Qualitative Research • Clinical Experience • Patient Preferences • Contextual Influence 13

What are Guidelines ? Guidelines may include several components: – Service delivery policies – Service delivery standards – Clinical guidelines and protocols – Clinical management plans 14

Developing Guidelines • Prioritizing Guideline Topic: – Burden of disease eg. major cause of mortality for a population – Uncertainty about the appropriateness of healthcare – Need to conserve resources in providing care – Variation in practice • Cardiovascular Diseases is a major category. 15

Why Develop National Guidelines ? Guidelines are key to improving access to high quality service delivery: – Provide the foundation on which high quality services can be built or strengthened – Reduce medical and access barriers – Standardize provider practices – Guide the content for inservice training and preservice education programs – Guide supervisory and management systems – Provide standards for monitoring and evaluating quality of care 16

Types of guidelines - major focus • clinical assessment / treatment – management of cardiac arrest • risk assessment / prevention – drugs to use in pregnancy • administrative – insurance pre-approval for surgery 17

Developing Guidelines • Setting – Inpatient – Outpatient • Time Frame – Emergency – Acute – Chronic 18

When are guidelines needed ? • Clinical practice guidelines are useful when: – the problem is common or expensive – there is great variation in practice patterns – there is enough scientific evidence to determine appropriate and optimal care – Clinicians work shorter hours with patients and have less time to get updated with EBM 19

Types of guideline statements • Recommendation for use • Option for use • Recommendation against use 20

How to create an evidence -based guideline 21

EBM Guidelines • • Choosing a topic Developing a question/s Finding the evidence Evaluating the evidence Write the guideline Implement the guideline Evaluate the guideline Disseminate the guideline 22

Finding the evidence for IGH • Many well known international databases • Local: SID, IRANMEDEX, Iran. Doc, etc • Knowing synonyms 23

Critical Appraisal • Look for flaws- written and omissions • Can you use it? • Is it applicable and transferable? 24

Write the guideline • Concrete, unambiguous, specific terms. • Key recommendations • Algorithms/pathways • Short version/comprehensive version • Educational packages 25

Extensive IGH Review Process • Local Scientific Committee Members (Cardiologists, • National network on CVD members (including members from • Representatives of International Guideline Development Groups • Organizational and Stakeholders • All comments submitted at each phase of the review process are carefully reviewed and considered by the Working Group • Finally, reaching a consensus nephrologists, endocardiologist, pediatricians, neurologists, internists, etc) the MOH deputies of health, treatment, food and drugs, evidencebased medicine and national research center, representatives, health education etc) 26

Implementation • The hardest part – Find out where the stakeholders stand • Actively for, passive, active against • What are the resistive forces • How can these resistive forces be undermined – Strategic planning • Best to erode resistance rather than push harder 27

Developing IGH Mostly depend on: • The Canadian Hypertension Education Program (CHEP 2010) • The European society Hypertension guidelines • The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure(JNC 7) • NICE clinical guidelines (UK) • The Australian guidelines 28

IGH Working Group Mandate To adapt, update, pilot, evaluate and disseminate the guidelines 29

How Often Guidelines are updated? • Our goal is to update IGH every two years or. . . • Anytime breaking clinical management or treatment comes up 30

Are IGH a duplication of those from CHEP, JNC 7, ESH, NICE? • No, IGH are developed based on international guidelines taking in consideration the local situation in Iran • A comprehensive and simplified versions will be available for physicians mainly GP and family physicians for use 31

How Effective can IGH be? • It can only be effective when they are implemented well and used routinely • The impact of CHEP program showed that after a decade of implementation, blood pressure level reduced remarkably and it’s related CVD consequences like stroke, MI and HF were reduced too • A survey in Canada showed that in 1986 -92 only 16% of hypertensives were treated and controlled another 23% were on treatment but suboptimal control. In 2006, similar study found that treatment and control improved markedly such that 66% of hypertensives had target control and only 14% were unaware of their diagnois 32

Steps in the Guidelines Process 33

Program Phases Planning Development Pilot Implementation Evaluation Revision Dissemination 34

Guideline ADAPTATION A systematic process that guides local groups to identify, evaluate, adapt and use already available guidelines for their own purposes. 35

Guideline ADAPTATION § An alternative to de novo development which requires extensive search and synthesis of primary research data § Reduces duplication of effort while maintaining the validity of recommendations § Encourages participative approach involving key stakeholders to foster local ownership of recommendations and promote utilization 36

Guideline ADAPTATION § Ensures consideration of (regional and local) contextual factors to ensure relevance for practice and improve uptake by targeted users § Increases knowledge and commitment to evidence-based principles by using reliable methods to ensure quality and validity § Promotes explicitness and transparency in documenting recommendations 37

Guideline Adaptation & Implementation: • Guideline adaptation is not an episodic activity but part of a continuum; groups requested further direction/support in planning implementation, evaluation of adherence and outcomes of implementation • Timeline may not be reduced with adaptation vs. de novo development. Important factors: § Nature of topic and health questions § Availability of guidelines § Panel expertise, access to resources 38

Guideline Adaptation Development Methodology • Getting started – Guideline topic selection – Panel or steering committee recruitment and establishment – Search, retrieval and critical appraisal of evidence sources – Identification of existing clinical practice guidelines • Defining the scope • Guideline apprasial – Screen for inclusion criteria – Use of AGREE instrument 39

AGREE Instrument : 6 Domains • Scope & Purpose • Stakeholder Involvement • Rigor of Development • Clarity & Presentation • Applicability • Editorial Independence www. agreecollaboration. org 40

www. agreetrust. org Note: Check this site for release of AGREE II Instrument (May 2010) 41

IGH Outline • Introduction • Diagnosis • Treatment • Follow-up • Self-care • prevention 42

Strategies for Implementation Training • There should be adequate advanced notice of educational forums, seminars, workshops • Training should be targeted to appropriate audiences • There should be ‘cross training’ between regulators and other audiences • There should be training within organizations • A mechanism should be established to address questions —within and across stakeholders 43

Implementation • Putting the guideline into practice • The appropriate authorities should manage the implementation plan • It is important to continue to communicate awareness about the guideline at the local and regional level • Appropriate resources should be allocated to implementation (time, personnel, money) 44

Implementation • Implementation is as, if not more important, than guideline development itself • During implementation, it is important to recognize the need to integrate any related guidelines • A mechanism should be put in place to identify issues that were overlooked or changing science 45

Management • There should be active monitoring of the utilization of guidelines • Regular communication and cooperative feedback is necessary • An annual report by all parties should be undertaken which details discrepancies between ideal and actual implementation processes • Mechanisms must be established to correct gaps in a guideline in a timely fashion • Continuing education is important 46

To Conclude: • The IGH development process up to now: – Clarified the purpose, scope – Defined the supporting infrastructure – Formed the steering committee, working panels, Iranian scientific committee and international advisory board – Did extensive search locking for the existing evidence-based guidelines (international) and selecting all peer reviewed publications from Iran – Apprasial for relevance, coverage, validity … – Developing the guidelines with the help of panels – Review by all local committees (twice) – Review by international advisory board – waiting – Adding most comments every time (which led to more comprehensive guidelines) – Apprasial during the meeting – Consensus 47