How Therapeutic Guidelines are produced
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 guidelines are comprehensive in that they cover all common disorders seen in clinical practice. The information is independent and unbiased and is a distillation of current evidence and opinion. 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.
The content of each topic is revised by an expert group every 3 to 4 years. The iterative cycles are based on shifts in the evidence base and response to feedback.
The essential principles underlying the process for guideline development stem from the production of the first guidelines in 1978, with the method being refined and improved over the years.
Independence and conflicts of interest
Choosing the topics
Formulating and revising the guidelines
Basis of recommendations
TGL is a not-for-profit independent organisation that is responsible for the production and publication of Therapeutic Guidelines. Its funds come solely from sales and subscriptions.
The independence of TGL’s publications is guaranteed through:
- TGL being independent of government and licensing authorities
- TGL being independent of any form of commercial sponsorship, including the pharmaceutical industry
- TGL having a strict policy on conflict of interest for directors, staff and members of TGL and members of the 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 conflict of interest policy.
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, lack of evidence) that would be assisted by establishing and promulgating guidelines for appropriate practice.
The decision to update current topics is based on shifts in the evidence base, feedback from clinicians, changing practice, changing patterns of drug usage or bacterial resistance, and other relevant issues.
The content of Therapeutic Guidelines is developed by expert groups.
Each expert group comprises approximately 14 people—including a chairman, an editor, a medical librarian, 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.
Factors taken into consideration in choosing members of the expert groups include:
- relevant expertise
- critical knowledge of, and familiarity with, the current literature
- constituencies and links to key professional bodies
- ability to work cooperatively
- willingness to challenge conventional thinking
- national representative opinion
- representation from different geographical areas and different practice settings.
Before a project commences, members of the expert group are asked to declare in writing (and then also verbally at each meeting) any interests or relationships they have that might influence their comments. These are taken into account during ensuing discussions and editing.
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. But, to make sure the advice will be helpful, the expert groups not only assess, interpret and distil the relevant evidence, but also contextualise and tailor the information to the likely clinical situations that will be faced by prescribers in the everyday care of their patients.
Decision-making in clinical practice is inherently complex and multifaceted. In addition to the evidence, other factors are considered to ensure the advice is relevant and useful. Examples of such factors include the adverse effects, availability and affordability of the treatment, risk factors, and patient characteristics and comorbidities.
‘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. In these ‘evidence-poor’ areas, recommendations for therapy may be based on the known pathophysiology of the disease, the clinical experience of expert group members, the adverse effect profile of the possible therapeutic options, 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 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 more expensive.
Because the totality of the evidence, and not just clinical trials, is taken into account when developing Therapeutic Guidelines, it is not appropriate to use tools to rank recommendations based on the hierarchy of evidence. The approach taken in Therapeutic Guidelines is to indicate the type of evidence behind a recommendation by including explicit statements in the surrounding text.
All major sources of information on which recommendations are based are cited in TGL’s electronic products (eTG complete and miniTG) and on the TGL website. If considered very important, specific evidence is referenced as a footnote in the print versions of the Guidelines, although this is kept to a minimum to ensure the readability of the text is not impeded.
A summary of major changes is accessible from the home page of TGL’s electronic products with each release, and as an insert to the books.
Once the manuscript has been finalised and approved by the expert group, peak organisations are invited to endorse the text. These organisations include The Royal Australian College of General Practitioners, The Society of Hospital Pharmacists of Australia, Royal College of Nursing Australia, National Prescribing Service and relevant specialty societies. See a list of endorsing bodies for each therapeutic area.
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 visits these users once or twice each year to discuss and record the feedback.
Before a topic is revised, accrued feedback on the previous version is collated and passed on to the expert group for their consideration when revising the text.
Users are encouraged to comment about the content or format of the guidelines by emailing comments to email@example.com or by completing the form at the back of TGL print publications.
Updated: May 3, 2013