The aim of Therapeutic Guidelines Limited (TGL) is to provide clear, practical, authoritative and succinct therapeutic information for busy health practitioners, for the management of patients with specific conditions.

The recommendations in Therapeutic Guidelines are based on the latest international literature, interpreted by some of Australia’s most eminent and respected experts, with each statement having been examined, subjected to challenge and discussed over a series of day-long meetings. The finished texts represent the essence of current available evidence.

Contents

Independence
Principles
Choosing the topics
Expert group
Management
Inaugural meeting
Formulating and revising the guidelines
Basis of recommendations
External preview and endorsement
Post-publication evaluation

Independence

Therapeutic Guidelines have been independently prepared and published since the first edition of Antibiotic Guidelines in 1978.

Therapeutic Guidelines Limited (TGL) is a not-for-profit independent organisation which is responsible for the production and publication of Therapeutic Guidelines. Its funds come solely from sales and subscriptions.

The independence of the Therapeutic Guidelines is guaranteed through:

• TGL being independent of government and licensing authorities
• TGL being wholly independent of any form of commercial sponsorship, including the pharmaceutical industry
• the guidelines being free of advertising
• TGL having a strict policy on conflict of interest for directors of TGL and members of the expert groups.

These principles are consistent with those of the International Society of Drug Bulletins, of which TGL is a member.

Principles

The aim of TGL is to provide clear, practical, authoritative and succinct therapeutic information for busy health practitioners, for the management of patients with specific conditions.

The guidelines are comprehensive in that they cover all common disorders seen in general practice. The information is independent and unbiased and is a distillation of current evidence and opinion. The text is arranged into chapters and sections according to diagnostic entities. Each section gives sufficient surrounding information to orient the reader, followed by succinct and explicit recommendations for therapy.

The guidelines are not primarily meant to instruct, but rather to assist prescribers in ensuring patients receive optimum treatment.

The content of each title is revised by an expert group every 2 to 3 years. The iterative cycles are based on response to feedback and shifts in the evidence base.

The essential principles underlying this process for guideline development stem from the production of the first guidelines in 1978, with the method being both refined and improved over the years.

Choosing the topics

The decision to develop guidelines in an area is determined by the board of TGL. For new areas the decision is based on one or more of:

• an expressed need by general or specialist practitioners, and/or other groups with interests or involvement in an area
• a perception of possible problems in an area, arising from expressions of dissatisfaction by practitioners or evidence from drug usage data
• a clear problem (eg size of health burden, cost, variations in practice, existence of available evidence) that would be assisted by establishing and promulgating guidelines on what is the most appropriate practice.

The decision to update current titles is based on feedback from clinicians, shifts in the evidence base, changing practice, changing patterns of drug usage or bacterial resistance, and other issues relevant to an area.

Expert group

Each expert group comprises approximately 12 people—including a chairman, an editor, experts in relevant medical specialties, a general practitioner, a pharmacist and a nurse. Depending on the subject matter, the group may also include experts from other areas, such as physiotherapy and nutrition. Members of expert groups are appointed by the board of TGL. Factors taken into consideration in choosing members include:

• relevant expertise
• scholarship
• constituencies and links to key professional bodies
• ability to work cooperatively
• willingness to challenge conventional thinking
• national representative opinion
• representation from different geographical areas.

Management

The chairman plays a pivotal role in the development of the manuscript as it is that person’s responsibility to ensure that the project proceeds harmoniously and according to the set process.

The editor, an employee of TGL, liaises with the chairman and expert group to plan a timetable and to ensure that the manuscript develops effectively, on schedule and within the set budget.

The editor prepares all the papers required for each meeting, including minutes, feedback on the previous edition (when applicable), correspondence regarding content, draft chapters and any other relevant background information.

The editor prepares detailed minutes of each meeting to document the basis for all recommendations, especially those which are new and controversial. The minutes are distributed to all members after each meeting for confirmation.

Inaugural meeting

At the initial meeting of each expert group, explanation and guidance are given on:

• intellectual property
• conflict of interest
• aims and format of the guidelines
• clarification of the scope of the content in light of the target audience
• importance of documentation of evidence to support the recommendations
• desirability of consultation with colleagues expert in the area.

Members of the expert group are asked to declare any interests or relationships they have that might influence their comments, and these are taken into account during ensuing discussions and editing.

Within the subject area, the group decides which, and to what level of detail, specific diagnostic entities need to be covered, taking into consideration the likelihood that a disease will be encountered. In some instances the group may also decide to include advice on some uncommon but serious diseases. Decisions about which entities should be covered may be influenced by feedback from users of an earlier edition.

Members agree on the allocation of tasks, with responsibility for the preparation of initial drafts being taken by individual members.

A schedule for a series of day-long meetings at intervals of approximately 8 weeks is planned to allow successive review and discussion of all drafts.

Formulating and revising the guidelines

The starting point for content is what a clinician needs to know to manage a patient with the given condition.

Thus, each section needs to include just sufficient surrounding information to orient the reader, followed by succinct but explicit statements regarding management and recommendations for therapy.

After the inaugural planning meeting, authors prepare initial drafts based on their clinical expertise and the current evidence in the relevant area, with the editor assisting the authors to identify and access relevant supporting information. This may include primary scientific papers, systematic reviews from the Cochrane Collaboration, reviews published in reputable journals and guidelines developed by other credible bodies.

The drafts prepared by the individual authors are circulated to all members of the group well in advance of scheduled meetings to allow ample time for the rest of the group to consider the material before meetings.

Each draft is debated in a face-to-face situation on multiple occasions with discussion becoming successively more exhaustive until the material in each chapter has been scrutinised, challenged and, if necessary, reworked. Areas in which there is controversy, rapid development or uncertainty are identified and further literature searches undertaken.

The editor liaises with individual authors to document the specific studies used to support the statements and recommendations, and copies of these references are retained on file.

Once the intent of the expert group is clear with respect to specific content, the editor assumes responsibility for the text, reorganising it according to house-style and format, and liaising as necessary with authors and the chairman.

The finished manuscript is the result of detailed scrutiny, collaboration and revision, involving a wide range of people and several editing stages. Individual chapters are no longer attributable to any one author. All members of the expert group are responsible for the entire manuscript.

For the preparation of each title, in addition to an inaugural half-day planning meeting, an average of 5 full-day meetings are required over a period of approximately 9 months, with the final meeting being devoted to a final scrutiny of the entire manuscript to ensure all members approve the whole text. The time taken to produce each manuscript, from the inaugural expert group meeting to publication, is approximately 14 months.

Basis of recommendations

The methodology required to develop content for Therapeutic Guidelines is different to, and not always entirely compatible with, that used to produce ‘reviews or summaries’ of the literature. Unlike reviews or summaries where evidence found in the literature determines the basis and scope of a text, the starting point for the development of Therapeutic Guidelines is a clinical problem.

The relevance, ‘generalisability’ and strength of the scientific evidence for the effectiveness of any given treatment are fundamental to the development of the content in Therapeutic Guidelines. In clinical areas where there is an abundance of evidence, there can be a reasonably high level of certainty about which treatment(s) should be recommended. But, to make sure that the advice will be helpful for clinicians, the relevant evidence is not only assessed, interpreted, and distilled, but is also contextualised and tailored to the clinical situation, and customised to ensure it is consistent with, or adaptable to, local circumstances.

Decision-making in medical practice is inherently complex and multi-faceted and, in addition to the evidence, other factors need to be considered to ensure the advice is relevant and useful. Examples of such factors include the availability and affordability of the treatment, risk factors and patient characteristics.

‘Evidence-rich’ areas are in the minority in clinical practice, so a large proportion of the material developed for Therapeutic Guidelines is in areas where there is little published evidence.

When the evidence is equivocal, there are sometimes differing but supportable positions. Acceptable alternatives from which prescribers can choose are presented, but ultimately the responsibility for resolving difficulties and producing a clear and unambiguous message based on a considered review of all the evidence and opinion lies with the expert group.

For ‘evidence-poor’ areas there is necessarily more reliance on expert opinion, and recommendations for therapy are developed based on an assessment of criteria such as the adverse effect profile, long-term safety data and cost. Using these criteria, older drugs that have been shown to have a reasonable adverse effect profile over a long period of time are often recommended as first-line therapy rather than newer drugs that have a less certain adverse effect profile (particularly in the long term), and are usually much more expensive.

If recommendations for treatment were based solely on the scientific evidence, instruments developed by other agencies to assign graded evidence hierarchies to the recommendations could be used. But because factors additional to the evidence are taken into account in the development of the recommendations in Therapeutic Guidelines, it is not possible to use these tools.

The approach taken in Therapeutic Guidelines to indicate whether a recommendation is based on strong evidence or otherwise is to include explicit statements in the surrounding text.

Major sources of information on which recommendations are based are listed in the electronic versions of Therapeutic Guidelines.

External preview and endorsement

Once the manuscript has been finalised and approved by the expert group, it is then circulated for preview by several experts who have been nominated by the chairman or identified by members of the expert group.

Once all feedback has been received, the editor clarifies and collates all comments and then works with the chairman to ensure all points are considered and any necessary changes are made.

If any substantial change is thought to be required, the expert group is again consulted to ensure that the whole of the final text meets the approval of all members.

Finally, organisations such as The Royal Australian College of General Practitioners, The Society of Hospital Pharmacists of Australia, and Royal College of Nursing Australia, other relevant professional bodies and the National Prescribing Service are invited to endorse the text.

Post-publication evaluation

The evaluation unit of TGL liaises with a network of approximately 160 users (general practitioners, specialists, pharmacists and students) to actively solicit feedback on the guidelines.

Participants in the network are provided with all Therapeutic Guidelines free of charge. Staff of TGL visit these users once or twice each year to discuss and record the feedback.

Before any new edition is commenced, accrued feedback on the previous edition is collated and passed on to the expert group for their consideration in the revision of the text.