Therapeutic Guidelines Limited (TGL) is an independent not-for-profit organisation. Its aim is to promote the quality use of medicines, and it does this through the writing, publication and sale of Therapeutic Guidelines.
Therapeutic Guidelines are written principally for prescribers (general practitioners and trainee physicians in particular) to provide clear, practical, succinct and up-to-date therapeutic information, for the management of patients with specific conditions.
The Guidelines are based on the latest international literature, interpreted by some of Australia’s most eminent and respected experts, with input from an extensive network of general practitioners and other users. The information is independent and unbiased and is a distillation of current evidence and opinion.
Therapeutic Guidelines are comprehensive in that they cover all common disorders seen in clinical practice. Topics and sections are arranged 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 ensure their patients receive optimum treatment.
Independence is a critical issue for TGL. Its reputation is staked on its publications and the independence of the therapeutic information that has been developed by its expert groups through interpretation of the literature and distillation of expert opinion. Its funds come solely from sales and subscriptions.
Key factors for this independence are:
- TGL’s independence of any form of government or commercial sponsorship including the pharmaceutical industry, and
- TGL’s strict policy on conflict of interest for Directors and members of its expert groups.
Conflicts of interest are minimised by careful selection of expert group members. Any remaining conflicts are declared and managed during the guideline development process in accord with TGL’s policy on conflict of interest. A register of declared interests for expert group members can be found under Expert groups.
TGL prides itself on being one of the few guideline development organisations that commits to revising topics on a regular basis. The decision to update current topics is determined by TGL Publishing Committee. Decisions are based on shifts in the evidence base, feedback from clinicians, changes in practice, changing patterns of drug usage or bacterial resistance, and other relevant issues. The current schedule permits revision of topic areas approximately every four years.
Occasionally, new guidelines are developed; the decision to develop new guidelines is determined by TGL Board of Directors. For new areas, this is based on:
- an expressed need by general or specialist practitioners, or other groups with interests or involvement in an area
- a perception of possible problems in an area, arising from feedback from clinicians or evidence from drug usage data
- a clear problem (eg size of health burden, cost, variations in practice, lack of evidence) that would be assisted by establishing and promulgating guidelines for appropriate practice.
The text of Therapeutic Guidelines is developed by expert groups.
Each group comprises approximately 14 people, including a chairman, an editor, and experts in relevant medical specialties, a clinical pharmacology trainee, a general practitioner, a pharmacist and a nurse. Depending on the subject matter, the group may also include a consumer or experts from other areas, such as physiotherapy and nutrition.
See a list of expert groups by therapeutic area.
The chairman and editor are employees of TGL and play pivotal roles in the development of the manuscript.
The chairman ensures the project proceeds harmoniously and that true consensus is achieved for all recommendations. The editor liaises with the chairman and expert group members to ensure that the manuscript develops effectively, on schedule and within the set budget.
The editor prepares the papers for each meeting, including minutes, feedback on the previous version (when applicable), correspondence regarding content, draft manuscripts and any other relevant background information.
The editor prepares detailed minutes (usually as a transcript) of each meeting to document the basis for all recommendations, especially those that are new or controversial.
At the initial meeting of each expert group, explanation and guidance are given to the members 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.
Within the subject area, the group decides on the specific conditions to be covered and the level of detail, taking into account the likelihood that a condition will be encountered. Sometimes advice on uncommon but serious diseases will be included. Decisions about which conditions should be covered may be influenced by feedback from users of an earlier version.
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 daylong meetings at intervals of approximately 8 weeks is planned to allow successive review and discussion of all drafts.
The starting point for content is what a clinician needs to know to manage a patient with the given condition.
Each section includes sufficient information to orient the reader, followed by succinct and explicit recommendations for therapy.
After the planning meeting, authors prepare initial drafts based on their clinical expertise and the current evidence in the relevant area. They are encouraged to also prepare a separate document summarising the rationale for their recommendations. The editor and the medical librarian assist 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 are circulated to all members of the group before scheduled meetings to allow time for group members to consider the material before the topics are discussed.
Each draft is debated in a face-to-face situation with discussion becoming successively more exhaustive until consensus is reached on the content. Areas in which there is controversy, rapid development or uncertainty are identified and further literature searches are undertaken if necessary.
The editor liaises with authors to document the specific studies used to support the statements and recommendations. 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. The topics 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 group of topics, usually a half-day planning meeting plus three full-day meetings are held over approximately 6 to 8 months. At the final meeting all topics are scrutinised to ensure all members approve the whole text. The time taken to produce each group of topics is usually 12 to 14 months.
The relevance 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 strong evidence, there can be a reasonably high level of certainty about which treatment(s) to recommend. However, to make sure that the advice is clinically relevant and applicable, the information must be contextualised to reflect the reality of everyday clinical situations—co-morbidities, risk factors, patient characteristics and affordability of treatment options are examples of important factors that must also be taken into consideration.
‘Evidence-rich’ areas are in the minority in clinical practice, so a large proportion of the material developed for Therapeutic Guidelines covers areas for which there is little published evidence. In these ‘evidence-poor’ areas, the known pathophysiology of the disease, the clinical experience of expert group members, and the adverse effect profiles, long-term safety data, and cost, of the therapeutic options become more significant in making recommendations. When drug recommendations are made, the order of preference is indicated by numbering them.
Rather than assigning levels of evidence to statements or grading recommendations, the Guidelines use the surrounding text to indicate the relevant evidence. This approach gives more opportunity to communicate the reason for making recommendations, particularly in ‘evidence-poor’ areas.
A summary of major changes is accessible from the homepage of TGL’s electronic products with each release, and as an insert to the books.
Key references are published in electronic versions in support of:
- major changes from previous text
- drug recommendations not within the product information
- controversial statements
- numbers (eg in tables and text where the source of the information is not readily apparent)
- any statement prefaced with ‘evidence shows’ (or similar) or citation of a specific trial.
Because of limited space, print versions of the Guidelines only include references for further reading or key references that might be helpful to the reader (ie major new and pivotal studies). However, all references are available for viewing on the TGL website via the eTG complete demonstration version.
The evaluation unit of TGL liaises with a network of approximately 200 users (including general practitioners, junior hospital doctors, health academics, pharmacists and students) to actively solicit feedback on the Guidelines. Participants in the network are provided with all Therapeutic Guidelines free of charge. The TGL evaluation officer contacts these users once or twice each year to discuss and record their feedback.
Users are also encouraged to comment about the content or format of the Guidelines by emailing comments to <firstname.lastname@example.org>.
Accrued feedback on the previous version is collated and passed on to the expert group for their consideration when revising the text.
Occasionally, feedback prompts changes to the content in between scheduled revisions. The decision to update a topic in between editions is made by TGL Publishing Committee, in liaison with the previous expert writing group.