How Therapeutic Guidelines are produced
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 cover common disorders 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.
- Updating topics
- Expert groups
- Planning meeting
- Formulating and revising the guidelines
- Basis for recommendations
- Evaluation and feedback
Independence is a critical issue for TGL because its reputation depends on the integrity of its publications. TGL is financially independent, with funding generated solely from sales and subscriptions to the Guidelines.
There are two key aspects of TGL’s independence. Firstly, TGL is independent of any form of government or commercial sponsorship including the pharmaceutical industry. Secondly, TGL has a strict policy on conflict of interest for staff, 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 on the relevant guideline page.
TGL prides itself on being one of the few guideline development organisations that commits to revising topics on a regular basis. The current schedule permits revision of topic areas approximately every five years. A targeted updating process between regular content reviews enables robust review of topics as required in response to significant signals that practice has changed. Targeted updates can affect a single or group of recommendations, or an entire topic or multiple topic areas. Occasionally, new guidelines are developed; the decision to develop new guidelines is determined by the TGL Board of Directors. For new areas, this is based on:
- an expressed need by users, medical organisations or government
- evidence of variable quality of care for a therapeutic condition
- a clear problem (eg size of health burden, cost, lack of evidence) that would be assisted by establishing independent guidelines.
The text of Therapeutic Guidelines is developed by expert groups.
Each group comprises approximately 14 people, including a chair, one or two editors, experts in relevant medical specialties, a general practitioner, and a pharmacist. Depending on the subject matter, the group may also include experts from other areas, such as nursing, physiotherapy and nutrition.
See a list of expert groups by guideline.
The chair and editor are employees of TGL and play pivotal roles in the development of the manuscript.
The chair ensures the project proceeds harmoniously and that consensus is achieved for all recommendations. The editor works with the chair and expert group members to ensure that the topics are written clearly and concisely, and prepares detailed minutes.
The editor is also the project manager. Editors plan the meeting schedule, and make sure the project finishes on time.
At the initial meeting of each expert group, information is given to members about:
- intellectual property
- conflicts of interest
- aims and format of the Guidelines
- the scope of the content in light of the target audience
- importance of documentation of evidence to support the recommendations.
The group discusses the scope of the Guideline and each topic, taking into account the prevalence of a condition. Sometimes advice on uncommon but serious diseases will be included. Decisions on scope are often influenced by feedback from users.
After the planning meeting, primary reviewers prepare a document summarising the rationale for changes to topics, then update the topics in line with current evidence and clinical expertise. The editor works with the primary reviewers to assemble supporting references. These usually include published scientific literature, systematic reviews from the Cochrane Collaboration, and guidelines developed by credible organisations.
The editor works on each successive draft of a topic, implementing TGL policies on scope, style and format. Topic drafts are circulated to group members before meetings to allow time for consideration of the proposed changes. The drafts are debated until consensus is reached on each change.
The finished manuscript is the result of detailed scrutiny, collaboration and revision by the entire expert group, so topics cannot be attributed to one author. The expert group is therefore the author of each topic and the Guideline overall.
Each guideline project usually requires a planning meeting plus six working meetings, held over approximately 9 to 12 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 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 for each release is provided on the homepage of TGL’s electronic products, and is provided 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.
Due to 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 in eTG complete.
TGL liaises with an Evaluation 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 Evaluation Network are provided with eTG complete, free of charge. TGL also contacts numerous stakeholders, such as the Australian Commission on Quality and Safety in Health Care and NPS MedicineWise, at the beginning of each project to ask for feedback and facilitate collaboration.
Users are 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 consideration when revising the text.
Feedback is an important signal for targeted updates to the content in between scheduled revisions. The decision to update a topic in between editions is made by the Editorial team in collaboration with the previous expert writing group.
Updated: June 2020