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Protocols and Guidelines

Guidelines and protocols are tools to reduce arbitrary variation in clinical practice. A clinical guideline is a compilation of statements concerning the management and treatment of a particular disease or condition (eg breast cancer, brachytherapy in prostate cancer, etc). These statements are formulated from an appraisal of published evidence, to provide statements as to the potential benefit or detriment of available investigations, interventions and treatments. These statements should be supported by a summary of the evidence base, together with the level of evidence and the strength of the recommendations.

The goals of guideline development and utilisation are

  • to assist clinicians with the management of patients
  • to reduce variability of management of similar conditions
  • to influence clinical practice and improve outcomes.

Guidelines may be derived from a rigorous analysis of the published evidence base for the subject, or by consensus. Whilst a systematic evidence based assessment provides the more robust product, this is a time consuming and demanding process. Conversely, consensus guidelines are generally faster to produce but suffer from the potential biases of the drafting committee. Due to the rapid change in medical knowledge, guidelines should be reviewed and revised regularly.

Many national or international groups have developed guidelines for a wide range of cancers. Whilst these may be based on a systematic and rigorous review of the literature, they may not be directly applicable to other countries, due to differences in health system infrastructure, cultural issues, disease presentation and comorbidity. For this reason guidelines frequently need to be adapted for the local conditions. However care must be taken to ensure that the validly of the guideline is not lost through local adaptation.

The recommendations within guidelines should be formulated such that audit of compliance with the guideline recommendations is feasible. Many guidelines emphasise that the optimal care of an individual patient may differ from the guideline recommendation. This is to be expected in a small proportion of patients. However it is incumbent for the attending physician to be aware of the guideline and to explain to the patient and, if necessary, the physician's peers, why the guideline was not followed in that case. 

By contrast, protocols are simpler documents that explicitly set out the sequence of actions (investigations, treatments etc) to be followed in a particular situation. Protocols do not generally have explanatory information should be based on the contents of guidelines.