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1.2 Evidence-based medicine (EBM)

1.3.2 Advisory Guidelines

Although the production of advisory guidelines does not directly relate to an act of parliament in the same way as the GMC guidelines do, failure by a doctor to comply with advisory guidelines can also lead to dispute with an employer or in the case of patient harm or percieved harm to negligence proceedings. It is important to highlight that “a doctor is not guilty of

negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in the relevant art.” (Bolam test 1957).[45] Therefore once again the doctor who goes against accepted professional guidance needs to be able to justify his actions appropriately.

There are a variety of bodies that produce advisory guidelines.

Guidance produced by Government (e.g. Department of Health (DoH), Welsh Assembly, Scottish Parliament)

These are usually service related guidelines (e.g. referral pathways, referral timelines). They are usually consensus statements that are the result of working groups where invited specialist(s) have been asked to give their opinion(s) to policy makers. Adherence is often strongly recommended by employment contracts with health providers or government agencies and it may be a contractual obligation to abide. There may be financial incentives or penalties which are often used to ensure compliance.

Guidance produced by local health-care providers (e.g. healthcare trusts or local networks)

These are both service and clinical guidelines. Typical examples are local prophylactic antibiotic prescription guidance, thrombosis prophylaxis guidance or blood transfusion guidance. These may be evidence-based or based on other published guidelines (from national guideline developers or professional bodies such as professional colleges / associations) with appropriate

adaptation to the local community being served. They may also be

consensus statements from local committees. These committees are usually made up of relevant specialist staff that volunteer their time to represent their department or specialty on the committee. Internationally there is a recent

trend for local hospitals to employ professional guideline developers to oversee their guideline and protocol development (Australia, USA).

Adherence is strongly recommended and certain employment contracts include a clause regarding possible legal action (under employment law) against the employee who fails to adhere to local protocols or agreed processes.

Guidelines produced by The National Institute of Health and Clinical Excellence (NICE).

NICE is an independent body commissioned in 1999 by the Department of Health to produce guidelines for healthcare professionals treating patients in the NHS in England and Wales. NICE guidelines are evidence-based

recommendations designed to promote good health and prevent ill health.

The guidelines address both clinical-effectiveness and cost-effectiveness issues.[46] There are different types of NICE guidelines.

Clinical guidelines

Clinical guidelines cover aspects of the management of a particular disease or condition. The evidence supporting different treatments is examined to assess whether they are effective for patients. The guidelines make

recommendations on which treatments should be made available in the NHS in England and Wales, in order to ensure the best care is available to all patients. Clinical guidelines sit alongside, but do not replace the knowledge and skills of experienced health professionals and consider both the clinical effectiveness and also the cost effectiveness of cancer treatments.

Service guidelines

Service guidelines make recommendations on how NHS services for patients should be organised in England and Wales. Both the anticipated benefits and the resource implications of implementing the recommendations are

considered.

Technology Appraisal guidance

Technology appraisal guidance focuses on the clinical and cost effectiveness of one or more technologies, such as new drugs, surgical procedures and medical devices.

Interventional Procedure Guidance

Interventional procedures (IP) guidance covers the safety and efficacy of interventional procedures used for diagnosis or treatment.

Public Health Guidance

Public health guidance deals with promoting good health and preventing ill health.

Guidelines produced by The Scottish Intercollegiate Guidelines Network (SIGN)

SIGN develops evidence based clinical practice guidelines for the NHS in Scotland. SIGN guidelines are derived from a systematic review of the scientific literature. SIGN guidelines are produced by guideline development group members, with support from the SIGN Executive according to

structured robust methodology.[46,47]

Guidelines produced by The Guidelines Audit and Implementation Network (GAIN.)

GAIN produces guidelines for the NHS in Northern Ireland. Its role is safety and quality improvement in Health & Social Care Services throughout

Northern Ireland through the commissioning of regional audit and guidelines as well as the promotion of good practice through the dissemination of audit results, and the publication and facilitation of implementation of regional guidelines.[48]

Guidelines produced by international guideline developing bodies Since the establishment of NICE in the UK other countries are also

establishing guideline-developing bodies. In the US there is the Agency for

Healthcare Research and Quality.[49] In The Netherlands, two bodies (CBO and NHG) publish specialist and primary care guidelines, respectively.[50]

The German Agency for Quality in Medicine (ÄZQ) coordinates a national program for disease management guidelines [51, 52]. These organisations are members of the Guidelines International Network (G-I-N). [50] G-I-N is owner of the International Guideline Library – the largest web-based database of medical guidelines worldwide - and pursues a set of activities aiming at promoting best practice and reducing duplication in the guideline world. The USA and other countries also maintain medical guideline clearinghouses. In the USA, the National Guideline Clearinghouse (NGC) maintains a catalogue of high-quality guidelines published by various organizations. In addition, the National Comprehensive Cancer Network, an alliance of leading US cancer centres also provided reputable guidelines.

Guidelines produced by professional medical organisations and societies Specialist working groups formed by members of the executive who have volunteered to sit on the guideline panel usually produce these guidelines. An alternative is that panel members are self-selected or nominated by their peers. The evidence provided varies with some societies producing very good quality evidence-based guidelines and others producing a higher number of consensus statements particularly when addressing topics where evidence is not available in the literature.