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Search Terms: antilipemic agent; hypocholesterolemic agent$. lipid$ adj2 (low$ or depress$) lipid modifying drugs; Dislipidaemia; Statins; HMGCoA inhibitors; familial hypercholesterolemia

Added: HMGCoA Reductase; Inhibitors, Simvastatin, Clofibrate, Procetafen, Bezafibrate, Niacin, Azetidienes, Colesevelam, Fibrate, Fenofibrate, Nicotinic Acid, Ezetimibe, Anticholesterolemic agent, Omega-3 fatty acids, Bioacids

Outcomes: Primary: CVD events (including CVD mortality, MI, CHD, stroke, and peripheral vascular disease), all case mortality

Secondary (Q15 only): lipid changes

Q18-19: Antiplatelets

Dates Total hits Retrieval list Included

Sources a/a 2002-2010 1761 85 16

Search Terms: Aspirin; Platelet Aggregation Inhibitors; Clopidogrel; dipyridamole; acetylsalicylic acid; antiplatelet; Warfarin; Antithrombotic agents; Thrombin inhibitors; Thrombin receptor antagonists; Heparinoids

Outcomes: Primary: CVD events (including CVD mortality, MI, CHD, stroke, and peripheral vascular disease), all case mortality

Secondary: Bleeding complications

Q20: Obesity

Dates Total hits Retrieval list Included

Sources a/a 2002-2010 321 61 4

Search Terms: Weight loss; weight reduction; reducing weight; Bariatric surgery; antiobesity medications; behavioural therapy

Outcomes: Primary: CVD events (including CVD mortality, MI, CHD, stroke, and peripheral vascular disease), all case mortality

Secondary: Bleeding complications

Q21: Diet and Nutrition

Dates Total hits Retrieval list Included

Sources a/a 2002-2010 1626 32+16 18

Search Terms: Diet;Intervention; Advice; Lifestyle; Sodium chloride/salt; Saturated fats;

Antioxidants; Omega-3 fatty acids; Soy protein; Glycaemic index or load;

Vegetables; Phytosterols, sterols, stanols; Nuts; Low carbohydrate; Low fat; High protein; Weight loss/ energy restriction; Fibre pectin; soluble fibre; Trans fats Outcomes: Primary: CVD events (including CVD mortality, MI, CHD, stroke, and peripheral

vascular disease), all case mortality

Secondary: Blood pressure, Lipid parameters, Diabetes

Q22-23: Physical Activity

Dates Total hits Retrieval list Included

Sources a/a 2002-2010 1211 103+2 17

Search Terms: Exercise; sports; physical education and training; exertion; physical$ adj2 Fit;

physical$ adj2 fitness; physical adj2 train$; physical adj2 activit$; train$ adj2 strength$; train$ adj2 aerobic$; aerobic$ adj2 exercise$; exercise$ adj2 train$;

Added FITNESS adj (Train$ or program$); Resistance training.

Outcomes: Primary: CVD events (including CVD mortality, MI, CHD, stroke, and peripheral vascular disease), all case mortality

Secondary (Q23): Blood pressure, Lipid parameters

Q24: Alcohol

Dates Total hits Retrieval list Included

Sources a/a 2002-2010 139 76 13

Search Terms: Alcohol Drinking; Alcohol drinking quantity; Alcohol drinking pattern; ALCOHOLIC BEVERAGES; BEER; WINE; alcohol; spirits

Outcomes: Primary: CVD events (including CVD mortality, MI, CHD, stroke, and peripheral vascular disease), all case mortality

Secondary: Blood pressure, Lipid parameters

Q25: Smoking

Dates Total hits Retrieval list Included

Sources a/a 2002-2010 417 79 1

Search Terms: Smoking Cessation; “TOBACCO USE DISORDER” ; TOBACCO;

NICOTINE;Tobacco, Smokeless; SMOKING; (quit$ or stop$ or ceas$ or giv$) adj2 smoking;TOBACCO; SMOKE POLLUTION; Second hand smoking; Passive smoking

Outcomes: Primary: CVD events (including CVD mortality, MI, CHD, stroke, and peripheral vascular disease), all case mortality

Q26 – Depression

Dates Total hits Retrieval list Included

Sources a/a 2002-2010 1178 22 0

Search Terms: Depressive disorder; Dysthymic disorder; depression/ depression, involutional/

depression, postpartum/; Seasonal affective disorder; Major depressive disorder;

Treatment pharmacological or other; Screening for depression

Outcomes: Primary: CVD events (including CVD mortality, MI, CHD, stroke, and peripheral vascular disease), all case mortality

4. Evidence tables

Data from included studies was abstracted along with a methodological appraisal (see below). This included information including citation, study type, evidence level (as per NHMRC Levels of Evidence and Grades for Recommendations for Developers of Guidelines (2009) patient number and characteristics, intervention/s, comparison, length of follow-up, outcome measure, effect size and funding source (as appropriate).

Methodological quality assessment

Two reviewers independently assessed the methodological quality of each included trial and resolved disagreements by consensus, with reference to a third reviewer if necessary.

Methodological quality of existing guidelines was assessed using the Appraisal of Guidelines Research and Evaluation Collaboration (AGREE) Agree instrument. Methodological quality of included systematic reviews and controlled trials was assessed using a modified checklist based on the Scottish Intercollegiate Guidelines Network (SIGN) Methodology checklist for systematic reviews and meta-analyses and the Guidelines International Network draft

Grade of

recommendation Description

A

Body of evidence can be trusted to guide practice

B

Body of evidence can be trusted to guide practice in most situations

C

Body of evidence provides some support for recommendation but care should be taken in its application

D

Body of evidence is weak and recommendation must be applied with caution

5.2 NHMRC grade of recommendation matrix: evidence-based recommendations

evidence tables. These checklists were developed and used previously by the NSF. Methodological quality of included cohort studies was assessed using the SIGN Methodology checklist for cohort studies. For diagnostic studies identified, the SIGN Methodological checklist for diagnostic studies was used.

5. Formulation of recommendations

To assist in the formulation of recommendations, where a body of evidence exists for each question, the NHMRC Grades process has been applied. This has resulted in an Evidence Statement for each question. The project team including the chair of the EWG, along with input of individual members of the EWG or corresponding group, used these statements and the underlying evidence to draft recommendations. The draft recommendations along with the summary matrices were initially discussed by the EWG at a face-to-face meeting of the working group on 7 September 2010. In addition to the summary matrices, economic modelling on the cost benefit of various drug therapies was commissioned and used to inform the development of the recommendations. Subsequent meetings via teleconferences were undertaken followed by a modified Delphi process (over two rounds) to achieve consensus (defined as >75% of responses from EWG) of the final wording of the recommendations. The recommended grading matrix was used to guide the strength of the recommendation.

5.1 Link between research and

recommendations following an absolute risk approach

These guidelines take an AR approach to the management of CVD risk which has posed some challenges in formulation of the recommendations. This is because although there is robust and compelling evidence in the published literature which clearly shows that pharmacotherapy reduces the levels of individual risk factors (blood pressure and lipids) with consequent reduction in CVD mortality or CVD events, this evidence is based on a single risk factor/

relative risk approach. Therefore the expert panel carefully considered the literature before making and grading the recommendations in an AR paradigm. When examining the evidence, consideration was given to any heterogeneity found between subgroups and the generalisability of the findings. The final grading of these recommendations was downgraded to account for the uncertainty of applying evidence from a relative risk approach to an AR paradigm.

Reporting of study results

Study results have been reported in the text of these guidelines in the same form as reported in the research i.e.

where relative risk reduction has been the measure used in the study, the results are reported using this term and have not been converted to AR reduction.

Matrix reproduced from NHMRC Levels of Evidence and Grades for Recommendations for Developers of Guidelines (2009)

6.2 Public Consultation

In line with the requirement under Section 14A of the National Health and Medical Research Council Act 1992, the public consultation process invited feedback during a month-long period in April 2011 and included an advertisement in the press inviting public comment.

In addition, a notice of the opportunity for comment was posted on the websites of NVDPA member organisations and copies of the guidelines were distributed to a broad group of identified stakeholders and networks. Consumer organisations were also contacted for comment. Finally, the draft document was circulated via the networks of the various experts supporting the project. Five prompted questions, modified from key questions included in the Guidelines Implementability Tool, were also included in the consultation feedback form to provide general feedback.

Overall there were 388 individual comments received from 24 individuals and 19 organisations (including key organisations such as the Royal Australian College of General Practitioners, Stroke Society of Australasia, state health departments, Australian General Practice Network and the Cardiac Society of Australia and New Zealand).

Public consultation resulted in many detailed responses, including many positive comments.

The major contentious issues and changes made in response to the public consultation are outlined below:

CBR

Consensus-based recommendations: developed by the guidelines expert working group when a systematic review of the evidence found either an absence of direct evidence which answered the clinical question or poor quality evidence, which was deemed not to be strong enough to formulate an evidence-based recommendation.

PP

Practice points: developed by the guidelines expert working group where a systematic review had not been conducted but there was a need to provide practical guidance to support the implementation of the evidence-based and/or consensus-based recommendations.

Additional guidance

Where no robust evidence was found for the search questions, the EWG followed the consensus process to develop consensus-based recommendations. Practice points were provided to give practical guidance to facilitate the implementation of the guidelines.

6. Consultation

6.1 Correlation with the draft National Evidence-Based Guideline on Secondary Prevention of Vascular Disease in type 2 diabetes

These guidelines were developed at the same time as the National Evidence-Based Guideline on Secondary Prevention of Vascular Disease in type 2 diabetes (currently being drafted). The two groups consulted extensively to ensure that the two guidelines provided a consistent continuum of care for patients (including cross representation on each advisory committee). As far as possible, given the evidence available for the different populations, the guidelines are consistent. Where there are differences in the grading of recommendations, this is due to the difference in evidence for the two populations.

5.3 Guidelines text

The body of the text was drafted by a consultant medical writer (medScript) based on an agreed framework. Early drafts were circulated for input from the EWG and finalised by the project team for public consultation.

7. Strategy for updating the guidelines

The guidelines will need to be updated no later than five years after being published (i.e. by 2016/7). However, given the current national reform activity around guidelines and standards no decision has been made regarding the strategy to review the currency of the guidelines and any method of updating the guidelines. These decisions will be made by the NVDPA in consultation with the NHMRC and other bodies (e.g. The Australian Commission on Safety and Quality in Health Care).

6.3 Contentious issues and responses

Issue Response

BP treatment thresholds

Concerns were raised by a number of individuals and organisations regarding the lack of a BP treatment for the low AR group. Suggestions were made to use the 160/100 mmHg threshold as had been recommended for the moderate-risk group.

The EWG agreed that pharmacotherapy for low risk adults is generally not appropriate taking an AR approach. However, it was agreed that a BP

≥160/100 mmHg should be treated with pharmacotherapy, both for the CVD risk and to prevent non-CVD complications such as heart failure and renal failure, therefore, a recommendation has been included to treat adults at low CVD risk who have persistent BP ≥160/100 mmHg with BP-lowering pharmacotherapy in addition to lifestyle intervention.

Assessment for under 45s and over 75s

Concerns were raised about imputing age 30 and using FRE as this will overestimate risk. Similarly concern that imputing 74 will underestimate risk in the over 74 age group.

The EWG balanced the lack of strong evidence supporting CVD risk

assessment for people aged under 45 with the need to provide some guidance for General Practitioners. The EWG therefore agreed that recommendations would not be made for CVD risk assessment of the under 45 year old age group (35 for A&TSI peoples). The text has been modified to remove the recommendations for risk assessment of younger people and to include some broad guidance on ensuring that people in this age group who have a strong family history of CVD or single, isolated, elevated risk factors are appropriately managed. The text was modified for the older age group to clarify that FRE is used to ensure that age is not the only consideration when assessing risk in this age group.

Moderate risk treatment Lack of clarity about this recommendation.

Recommendation has been divided into two recommendations to clarify the meaning.

Lipids

Queries arose regarding interpretation of the evidence especially for low-risk populations.

References have been reviewed and text modified to ensure that primary and secondary prevention evidence is appropriately identified. Evidence was also updated with recent meta-analyses.

Monitoring

Lack of clarity about whether AR is used to monitor progress of treatment or whether treatment is monitored by individual risk factors.

Text inserted to explain that AR is the entry point for treatment and treatment decisions are made on the basis of risk level, but treatment response is monitored by measurement of multiple individual risk factors.

8. Implementation considerations

8.1 Background

The NVDPA’s new Guidelines for the Management of Absolute Cardiovascular Disease Risk is an important step along the path to improved prevention of CVD in Australia.

Of greater importance is the dissemination and application in practice. Like the guidelines themselves, implementation strategies should use an evidence-based approach based on an underlying framework for CVD prevention. In addition to the various NVDPA guideline development groups, establishment of this plan was enhanced by obtaining structured feedback at a meeting of key stakeholders (46 government, non-government, consumer and professional organisation representatives) on 3 March 2011. This meeting was called to specifically address implementation considerations from a broad range of perspectives.

8.2 Strategic framework

These guidelines are one important part of a coordinated strategic framework for improving CVD prevention in Australia. This framework includes activities at an individual

and population level to raise awareness of CVD risk, assess risk and manage risk to prevent CVD as outlined in diagram 8.2. These guidelines focus only on comprehensive risk assessment and management aimed at primary prevention of CVD. Therefore, the guidelines and implementation strategies should not be considered as a standalone process but need to be linked to other important strategies both at an individual and population level to maximise their impact.

8.3 Levels to consider when implementing guidelines

Local factors operate over several different levels; all need to be considered to maximise the effect of guidelines. These levels are broadly described into four main categories:

professional, organisational, consumers and regulatory/

financial. Strategies to address barriers identified at each of these levels need to be developed. Strategies that enhance enabling factors should also be created. These are briefly described below:

1. Professional level: strategies supporting health professionals to adopt recommendations in the guidelines. Strategies include: