ADAPTE (GCP)
The ADAPTE Collaboration is an international collaboration of researchers, guideline developers, and guideline implementers who aim to promote the development and use of clinical practice guidelines through the adaptation of existing guidelines. The group's main endeavour is to develop and validate a generic adaptation process that will foster valid and high-quality adapted guidelines as well as the users' sense of ownership towards the adapted guideline. Following the finalization of the ADAPTE Manual and Resource Toolkit and their evaluation, the ADAPTE Collaboration dissolved and transferred the ADAPTE process and its resources to the Guidelines International Network (G-I-N) to facilitate its dissemination.
G-I-N (www.g-i-n.net) made this version of the ADAPTE Manual and Resource Toolkit (version 2.0) available for free on its website. G-I-N established an Adaptation Working Group to support groups undertaking or planning to undertake guideline adaptation and to handle further developments and refinements of the ADAPTE Manual and Resource.
The current ADAPTE methodology and resources are based on the results of an evaluation conducted on a draft manual and toolkit: upon requesting the ADAPTE resources, potential users were sent a survey asking their impressions about the resources and the proposed process.
ADAPTE: To use or not to use?
The ADAPTE method remains controversial (also within KCE). Some of the discussion points are summarized below:
- One of the main arguments in favour of ADAPTE is that it would be more efficient. However, this is not proven yet, and the survey mentioned above indicated that savings in time are probably fairly modest in a lot of cases. One of the main reasons for this is the fact that the underlying evidence for each recommendation needs to be verified anyway.
- ADAPTE and GRADE: if the source guideline did not use GRADE, an appraisal and structuring of the underlying evidence is needed, which is time-consuming. On the other hand, the same is true for systematic reviews that did not use GRADE, which are often used as a starting point at the KCE.
- ADAPTE critically depends on the availability of recent high-quality guidelines that can be sufficiently trusted. These are not always available, and even high-quality guidelines do not always have exactly the same scope as the guideline to be developed. Above this, high quality (as measured by the AGREE II instrument) is not a guarantee for a correct content.
- ADAPTE may be useful because clinical recommendations do not automatically and mechanically follow from the available evidence. Interpretation by clinicians is necessary and a good recommendation can highlight the pitfalls or the acceptability issues quoted by clinicians. Ideally, these considerations are already available in the selected source guidelines. Furthermore, identifying published high-quality guidelines allows to compare our recommendations with those from other countries, institutions, etc.
These issues were discussed during two internal consensus meetings at the KCE. The following conclusions were reached:
- ADAPTE can only be used when high-quality, recent guidelines are available that are in line with the defined PICO. This implies that a GCP project always starts with a search for guidelines. The following criteria will need to be taken into account when assessing the relevance of a guideline:
- All identified guidelines will need an assessment with the AGREE II instrument by two independent reviewers. Although the domain scores of AGREE II are useful for comparing guidelines and will inform whether a guideline should be recommended for use, the AGREE Consortium has not set minimum domain scores or patterns of scores across domains to differentiate between high-quality and poor-quality guidelines. These decisions should be made in consensus by the reviewers and guided by the context in which AGREE II is being used. Quantified cut-offs, while easy to use and enhancing reproducibility, are not recommended, because they have serious validity problems. The most important domain to be taken into account is ‘Rigour of development’.
- A criterion that could be taken into account as well is the degree of detail provided by the guideline on the evidence that was used for developing the recommendations. In order to apply GRADE correctly a fair amount of detail is needed: in case it is necessary to retrieve all the primary studies, the gain of adapting a guideline becomes limited.
- Updating a guideline with a search date that is too old may not be efficient, although it is difficult to recommend a general rule. Two years could be used as a rule of thumb, although this is very context- and topic-specific.
- Each research team can decide to use or not to use ADAPTE based on written arguments. This decision should be made when the research protocol is written. In case of subcontracting, the choice of method will have to be discussed with the subcontractor. Transparent and documented judgement is key here, not the blind application of a set of rules.
- If it is decided to use ADAPTE, the ADAPTE Manual and Resource Toolkit should be carefully read. The protocol should contain a clear description of how ADAPTE will be used (e.g. only used for some research questions, update of source guidelines with new evidence, etc).
The ADAPTE methodology
The ADAPTE methodology is exhaustively presented in the ADAPTE manual, being accompanied by a resource toolkit [1]. The methods aim to suit the needs of a broad range of stakeholders (from novices to those experienced with guideline development and groups with lesser or greater resources). The key aspects are summarized below.
The adaptation process basically consists of three main phases, each with a set of modules (see Figure on next page):
- Set-up Phase: Outlines the necessary tasks to be completed prior to beginning the adaptation process (e.g., identifying necessary skills and resources).
- Adaptation Phase: Assists users through the process of selecting a topic to identifying specific health questions; searching for and retrieving guidelines; assessing the consistency of the evidence and the guideline quality, currency, content, and applicability; decision making around adaptation; and preparing the draft adapted guideline.
- Final Phase: Guides the user through the process of obtaining feedback on the document from stakeholders impacted by the guideline, consulting with the developers of source guidelines used in the adaptation process, establishing a process for the review and updating of the adapted guideline, and creating a final document.
The ADAPTE process is supported by resources to facilitate its application. Each module of the resource toolkit provides a detailed description of the steps, the products and deliverables, and the skills and organizational requirements.
At the KCE, a summary of the evidence on which the recommendations are based is usually provided in tables, and until now all selected guidelines were updated with more recent evidence. This may not always be necessary, and under time constraints experts in the field could be consulted to see if there are recent developments, provided that the search date of the guideline is not to old.
[1] Can be downloaded from the G-I-N website at http://www.g-i-n.net/activities/adaptation