Clinical guidelines are documents that attempt to provide clinicians and patients with up to date information regarding appropriate decisions for a particular disease. Examples include the NHMRC guidelines for endometrial cancer treatment, or the NCCN guidelines that are published for multiple cancer sites. Development of these guidelines is a complex task that requires input from multiple stakeholders.
Development of Guidelines
In some cases, guidelines may already exist. In this case, it needs to be decided whether new guidelines are required. Examples of guidelines that may not be applicable are:
- Those based on a health system that is radically different from Australia (eg. pancreatic cancer guidelines will differ from Europe to the USA)
- Those based on outdated data (eg. renal cancer guidelines from before 2005)
Other tumour sites may be so rare that guidelines are not practical as there is minimal evidence to guide clinicians.
If the consensus is that there are no guidelines that are suitable then a new guideline can be drafted. For this process, it is essential to include relevant clinicians and other involved specialists as well as the government; this depends somewhat on the tumour site.
- Surgical, medical oncology, radiation oncology and palliative care physicians should be included for most sites. GP representation may also be helpful as they are often the clinicians who initially become aware of the problem
- Allied health may be relevant in select cases (eg. speech pathology/dietician for head and neck cancer guidelines)
- Nursing staff may provide input on some aspects of patient care during or after treatment
- Government representation is helpful as it may influence recommendations (e.g. the government may not be able to pay for the latest $10,000 per day targeted therapy, in which case it would be difficult to include this as a strong recommendation unless the evidence was strongly supportive)
Once the specialist panel is decided, the outcomes to be examined are determined. These are usually overall survival, disease specific survival, local control and/or quality of life.
A review of the available evidence is conducted. This may be straightforward when unequivocal trials or meta-analyses have been performed (eg. squamous cell carcinoma of the head and neck, breast cancer) but may be more complicated when comparitive evidence is lacking (prostate cancer).
The evidence is ranked according to strength (see research). In some cases, there is no available evidence and a consensus should be sought from all parties. If no consensus is reached, then the various options should be included, with an explanation.
When the guideline is written, the different steps that are supported by evidence should have this indicated clearly (eg. level 2b for randomised evidence, level 1 for meta-analysis). Consensus opinion and disagreements should also be noted so that readers can make their own conclusions and decisions when the evidence is lacking.
Prior to release of the guideline, draft copies should be evaluated in smaller groups to ensure they are both helpful and usable. If this is promising, the guidelines are released to clinicians, and should be made available on easily accessible internet pages as well.
Guidelines need to be reviewed regularly, and particularly if there is dramatic new evidence that changes specific recommendations. A policy for a yearly or bi-yearly review should be implemented for most guidelines to ensure they remain up to date.
In summary, the steps are:
- Assess for current, relevant guidelines, and if not present
- Assemble multidisciplinary group including doctors, nurses, allied health and government representatives
- Review available evidence and grade different options
- For non-evidence based recommendations, achieve consensus amongst the multidisciplinary group or give the different options available
- Write the guidelines, highlighting the strength of the recommendations
- Pilot the guidelines on small groups to ensure they are workable
- Release the guidelines, likely on central internet sites (e.g. EviQ, NHMRC website) and in the post
- Develop a review policy for the guideline so that new information can be incorporated into the guidelines as they arise. This is perhaps best done on sites such as UpToDate or the NCCN guidelines which are reviewed regularly.