So, you want to write a clinical guideline: how to avoid falling off the cliff.

If someone asks you to write a clinical guideline or be involved in developing a new health policy, you could be forgiven for saying: no! This is tough, time consuming and has driven many good people to a state of frustration and disbelief, verging on despair.

Busy clinicians require support for their patient-related decision-making and this should be provided by evidence-based clinical guidelines. Who better to develop such materials than clinicians with expert understanding of the health problem under consideration and the specific areas requiring guidance. Sadly, clinicians are time poor, often lack experience and confidence in such activities and would be pleased if someone else would do the job, though the very same clinicians are the first to complain about a new guideline or policy, especially if it doesn’t fit with their ‘clinical experience’ or personal view of the matter.

Three tales of guideline/policy development

I have had the opportunity to be involved in the development of both guidelines and policy at a national level. My initial foray was as Chair of the Guidelines Review Group responsible for the development of National Health and Medical Research Council (NHMRC) endorsed ‘Screening to prevent cervical cancer: guidelines for the management of asymptomatic women with screen detected abnormalities’, which finally saw the light of day in 2005 after a protracted, difficult and damaging process. The previous NHMRC guidelines were out of date and needed review. We followed the NHMRC process¹, and this was time consuming, expensive and difficult to keep to desired timelines. An anticipated two-year involvement became five years owing to the rigour of the NHMRC process and the unexpected vociferous opposition and personal attacks from some quarters, despite the quality of the evidence supporting the recommendations.

Much of the difficulty resulted from a lack of initial consultation and discussion with those affected (the stakeholders) and not providing them with a forum to participate, contribute and voice possible concerns at the outset. Public consultation over draft documents is a mandatory part of the NHMRC process. Early consultation is not. In my opinion, early and ongoing involvement of potentially affected stakeholders (partners in the process) is critical to acceptance of new guidelines/policy/strategies. Failure of some representative committee members to voice their concerns until very late in the process was also unhelpful. Speak out and speak early!

The main controversy resulted from reluctance to accept the safety of one recommendation, namely a 12-month delay in colposcopy for possible or definite low-grade squamous intraepithelial lesions. We were blindsided by vocal and public opposition (not supported by evidence of harm) that gained substantial media publicity producing confusion and doubt among health professionals, consumers and the NHMRC committee charged with reviewing and endorsing the guidelines. This resulted in a frustrating 12-month delay and significant further work and expense, in order to finalise and gain NHMRC approval of these necessary national guidelines. Subsequent monitoring of these guidelines has demonstrated their safety.²

My second effort was as Deputy Chair (Chair: Alison Brand) of a Working Party developing ‘Clinical practice guidelines for the treatment and management of endometrial cancer’, under the auspices of, and endorsed by, the Cancer Council Australia (CCA), to be published in a Wiki format for web-based access and timely revision as needed.³ The expert multidisciplinary membership was responsible for defining the scope of the guidelines, assessment and defining the level of the evidence (systematically collected by the CCA Secretariat) and writing the relevant chapters of the document. Early consultation with stakeholders was not deemed necessary owing to the nature of the task. Nationally accepted guidelines for endometrial cancer management were not available, though most treating institutions had local guidelines, and national consensus though desirable was lacking. Public consultation of the draft guidelines (with health professionals, specialist colleges and societies and consumers) was constructive with little dissent and general acceptance. Those potentially affected were few in comparison with the ‘screening to prevent cervical cancer guidelines’ and this was predominantly documentation of current evidence-based practice rather than a substantial change to current and accepted practice requiring attention to the principles of change management processes.

My most recent involvement has been Chair of the Renewal Steering Committee (RSC), National Cervical Screening Program (NCSP), Federal Department of Health Australia, charged with steering the process of the renewal of that program (and developing new government policy) in the light of new evidence about cervical cancer prevention and screening, new technologies and a changed health environment, including human papillomavirus (HPV) vaccination. This process, under the auspices of the Department of Health, reviewed the evidence around cervical cancer prevention and screening, with subsequent economic and health outcome modelling. The systematic evidence review was carried out by a nationally recognised group from the University of Sydney, answering questions that were formulated by the RSC and a Partner Reference Group, composed of interested health professionals, industry and consumer groups. This early consultation and involvement of the Partners and their ongoing involvement with further critical consultations and e-newsletters was a major factor in the success of the process. An informed, dynamic and responsive Secretariat was essential to maintaining timelines. Also important was the involvement of the expert government Medical Services Advisory Committee and its processes in the review of the evidence and economic modelling documents, leading to authoritative and independent evidence-based recommendations regarding the renewed cervical screening program.⁴

Guidelines versus policy

Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances. They are usually not considered to be compulsory or mandatory, but are ‘guidance’ as to current evidence-based best practice and should have a positive impact on healthcare. Clinicians who choose not to follow local or nationally accepted clinical guidelines, should ensure adequate documentation of their reasons and discussion with the patient, for in the event of a poor clinical outcome or subsequent ‘issues’ there is always the potential for medico-legal action.

Policies are the principles, rules and procedures formulated or adopted by an organisation (such as a hospital, health department or business) to reach its long-term goals (such as improved healthcare, patient and staff safety and so forth) and are, typically, published in a widely accessible format. They are usually considered to be compulsory and, in terms of national health policy, form the basis for the ongoing funding of specific health programs. Policies may change based on new evidence, as typified by the recent Renewal of the NCSP (see above⁴), where a change from two-yearly Pap testing from age 18–69 to five-yearly HPV partial genotype testing every five years from age 25–74, has been recommended and recently supported by the Australian Health Ministers Advisory Council.

Getting it right

I will focus my comments on guideline development, as this is the most common involvement for clinicians. The NHMRC provides leadership and exhaustive (and exhausting!) documentation¹; for those wishing to develop clinical guidelines to be approved by the NHMRC or who seek guidance regarding an acceptable and robust development process. Clinical practice guidelines should be based on the systematic identification and synthesis of the best available scientific evidence and make clear recommendations for health professionals practising in an Australian healthcare setting. The NHMRC requirements for developing clinical practice guidelines are designed to ensure this standard is upheld.⁵; These requirements are summarised below.

Clinical guidelines should:

• provide guidance on a clearly defined clinical problem based on an identified need;
• be developed by a multidisciplinary group that includes relevant experts, end users and consumers affected by the clinical practice guideline;
• include a transparent process for declaration and management of potential conflicts of interest by each member of the guideline development group;
• be based on the systematic identification and synthesis of the best available scientific evidence;
• make clear and actionable recommendations in plain English for health professionals practising in an Australian healthcare setting;
• be easy to navigate for end users;
• undergo a process of public consultation and independent external clinical expert review; and
• incorporate a plan for dissemination including issues for consideration in implementation.

When considering developing or reviewing clinical guidelines, it is important to ask the following questions:

1. Why are these guidelines needed and for whom are they intended?
   1. Are they new guidelines for a new technology or intervention (drug or technique)?
   2. Are they a ‘revision’ of outdated guidelines?
   3. Are the existing guidelines really out of date, or have they come to their previously determined ‘use by date’ and need review to ensure relevance?
   4. Are guidelines needed to assist the procedural process resulting from a new overarching policy decision (like Renewal of the NCSP)?
   5. vIs there a general understanding and agreement (by those affected) that new guidelines (or policy) are in fact needed?
   6. Is there known new information that puts the current guidelines ‘at risk’ of being dangerous or irrelevant?
   7. Is this an urgent matter and, if so, is the reason for urgency understood?
   8. Is it a multi-disciplinary issue and, if not, could a specialist group be sufficient to develop the guidelines (such as colposcopy or similar procedure or topic)?
2. Who should develop/revise these guidelines?
   1. Is a small or large group of people needed?
   2. Which disciplines need to be represented?
   3. Is a representative of the Aboriginal and Torres Strait Islander community included?
   4. Would the presence of a ‘consumer’ aid the process – usually essential?
   5. Should the members be ‘individuals’ or ‘representatives’ of organisations (sometimes individuals with recognised expertise may be more efficient and more interested in getting the job done)?
   6. Is previous experience of guideline development necessary or desirable?
   7. Who will gather the evidence and perform a systematic review?
   8. Who is responsible for choosing the people to be involved?
   9. Who will write the document?
   10. Is there sufficient expert secretarial support for this process?
   11. Governance: who will Chair the group, how will the Chair be chosen and who will it report to?
   12. Who will be funding this process and the implementation phase?
   13. Is the funding realistic?
3. What should be included in the scope of the guidelines: terms of reference?
   1. What are the overarching policy and principles?
   2. Is there agreement as to the scope of the topic?
   3. If not, who is responsible for defining the scope?
   4. Is the scope ‘realistic’ and achievable in the timeframe (see below)?
4. When should this task be completed?
   1. What are the timelines for the various parts of the guideline development and its implementation?
   2. Is this realistic?
   3. Are the members of the guideline group able to commit the time needed and participate actively in a timely fashion?
   4. Is there a built-in buffer for unexpected delays?
   5. Enthusiasm/output among committee members may wane with time, has this been accounted for?
   6. If markedly delayed, the guidelines could be out of date
      by the time of publication – how will this be resolved?
5. How should this process be carried out?
   1. Does this process require an expert multidisciplinary group?
   2. Have potential conflicts of interest in the group been identified and addressed?
   3. Is the NHMRC guideline development process⁵ to be followed either completely or in part, or is there some other recognised authority (professional body, specialist college, university) to guide this process?
   4. So that the guidelines cannot be dismissed as without authority or credibility, ill informed, biased or irrelevant, has the process (and its authority) been clearly defined at the outset?
   5. Has an implementation plan been defined early in the process?
   6. To help prevent much dissension and heartache down the track, has consultation with all stakeholders been considered at the beginning of the process?
   7. If necessary, has it been determined how to capture dissenting evidence, but still move forward?
   8. Has an online interactive ‘tool kit’ to complement the guidelines and facilitate their ease of use been considered and developed?

Finally, guideline (and policy) development offers clinicians the opportunity to get involved in large-scale improvements to healthcare and is a worthwhile mechanism to make a contribution to the community we serve. I hope that by considering my suggested approach of Why, Who, What, When and How, that your involvement will be productive and rewarding.