Table 2.
Adolopment process and relation with the Guidelines 2.0 checklist
| Guidelines 2.0 checklist | ‘Adoloped guideline’ process | ||
|---|---|---|---|
| Step | Description | Transferred from ‘source guideline’ process | Conducted specifically for the ‘adoloped guideline’ process |
| Organization, Budget, Planning and Training | Organization, budget, planning and training involves laying out a general but detailed plan describing what is feasible, how it will be achieved and what resources are required to produce and use the guideline. The plan should refer to a specific time period, and be expressed in formal, measurable terms. | 1. Detailed plan set between the Weill Cornell Medical College in Qatar, the Middle East Rheumatoid Arthritis Consortium (MERAC), and the American University of Beirut GRADE Center 2. Funding through the Qatar National Research Fund and Weill Cornell Medical College 3. Training of panelists on the GRADE approach through training videos and a one-day workshop preceding the panel meeting |
|
| Priority Setting | Priority setting is the identification, balancing and ranking of priorities by stakeholders. It ensures that resources and attention are devoted to those general areas (e.g. chronic obstructive pulmonary disease, diabetes, cardiovascular disease, cancer, prevention) where health care recommendations will provide the greatest benefit to the population, a jurisdiction, or a country. A priority-setting approach needs to contribute to future plans while responding to existing potentially difficult circumstances.92,93 | Project triggered by opportunity presented by the publication of the ACR RA guidelines. | Priority set based informal discussions with regional experts |
| Guideline Group Membership | Guideline group membership defines who is involved, in what capacity, and how the members are selected for the guideline development and at other steps of the guideline enterprise. | Regional and international content experts and methodologists recruited: into (1) the guideline executive committee; (2) the guideline coordination team; and (3) the guideline panel | |
| Establishing Guideline Group Processes | Establishing guideline group processes defines the steps to be followed, how those involved will interact, and how decisions will be made. | 1. Executive committee: oversaw work done and advised on process and methodology 2. Coordination team: conducted literature reviews, produced documents, and provided guidance and support to panelists 3. Panel members: were involved in prioritizing questions, contributing contextual information and participating in the final meeting 4. Decisions reached through discussion, consensus building and voting |
|
| Identifying Target Audience and Topic Selection | Identifying target audience involves describing the potential users or consumers of the guideline. Topic selection defines the topics to be covered in the guideline (e.g. diagnosis of chronic obstructive pulmonary disease). | Target audience: same as that of ACR RA guidelines, i.e., clinicians and their patients with RA. The scope (treatment of RA) and range of topics were those of the ACR RA guidelines |
The executive committee selected one out of the four topics addressed in ACR RA guidelines, that is the treatment of early RA patients |
| Consumer and Stakeholder Involvement | Consumer and stakeholder involvement describes how relevant people or groups who are not necessarily members of the panel but affected by the guideline, e.g. as target audience or users, will be engaged. | The executive committee involved a rheumatology clinic nurse as panelist | |
| Conflict of Interest Considerations | Conflict of interest considerations focus on defining and managing potential divergence between an individual’s interests and his or her professional obligations that could lead to questioning whether the actions or decisions are motivated by gain, such as financial, academic advancement, clinical revenue streams or community standing. Financial or intellectual or other relationships that may impact an individual or organization’s ability to approach a scientific question with an open mind are included. | The executive committee developed a policy document for both declaration (using the WHO COI form) and management of COI. | |
| (PICO) Question Generation | (PICO) Question Generation focuses on defining key questions the recommendations should address, including the detailed population, intervention (including diagnostic tests and strategies) and outcomes that will be relevant for decision making (e.g. should test A be used, or should treatments B, C, D or E be used in chronic obstructive pulmonary disease). | The executive committee considered all PICO questions from the ACR guidelines for the selected topic (early treatment of RA patients) | The coordination team surveyed panelists to prioritize questions for the EMR setting. The top 8 questions were selected |
| Considering Importance of Outcomes and Interventions, Values, Preferences and Utilities | Considering importance of outcomes and interventions, values, preferences and utilities includes integrating in the process of developing the guidelines, how those affected by its recommendations assess the possible consequences. These include patient and carer knowledge, attitudes, expectations, moral and ethical values, and beliefs; patient goals for life and health; prior experience with the intervention and the condition; symptom experience (for example breathlessness, pain, dyspnea, weight loss); preferences for and importance of desirable and undesirable outcomes; perceived impact of the condition or interventions on quality of life, well-being or satisfaction and interactions between the work of implementing the intervention, the intervention itself, and other contexts the patient may be experiencing; preferences for alternative courses of action; and preferences relating to communication content and styles, information and involvement in decision-making and care. This can be related to what in the economic literature is considered utilities. An intervention itself can be considered a consequence of a recommendation (e.g. the burden of taking a medication or undergoing surgery) and a level of importance or value is associated with that. | The executive committee considered all outcomes addressed by ACR for the prioritized questions | 1. The coordination team: • Sent outcome rating survey to panelists • Searched literature for studies on patients’ values and preferences, • Solicited panelists for additional studies on patients’ values and preferences |
| Deciding what Evidence to Include and Searching for Evidence | Deciding what evidence to include and searching for evidence focuses on laying out inclusion and exclusion criteria based on types of evidence (e.g., rigorous research, informally collected), study designs, characteristics of the population, interventions and comparators, and deciding how the evidence will be identified and obtained. It also includes but is not limited to evidence about values and preferences, local data and resources. | The ACR RA guideline working group shared their evidence reviews | The coordination team: 1. Searched for SRs and prioritized them based on directness, low risk of bias, and up-to-date 2. Updated searches for primary studies using same eligibility criteria used by ACR 3. Searched for resource use data using filter limiting search to EMR region 4. Searched for evidence on and values and preferences 5. Solicited panelists for additional studies on baseline risks and resource use |
| Summarizing Evidence and Considering Additional Information | Summarizing evidence and considering additional information focuses on presenting evidence in a synthetic format (e.g. tables or brief narratives) to facilitate the development and understanding of recommendations. It also involves identifying and considering additional information relevant to the question under consideration. | The ACR RA guideline working group shared their RevMan files | The coordination team: 1. Updated the RevMan files with newly identified studies 2. Solicited from panelist additional information relevant to the question under consideration |
| Judging Quality, Strength or Certainty of a Body of Evidence | Judging Quality, Strength or Certainty of a body of Evidence includes assessing the confidence one can place in the obtained evidence by transparently evaluating the obtained research (individual studies and across studies) and other evidence applying structured approaches. This may include but is not limited to evidence about baseline risk or burden of disease, the values and preferences, resource use (cost), estimates of effects, and diagnostic test accuracy. | The ACR RA guideline working group shared GRADE Pro files shared | The coordination team revised ratings in the GRADE evidence profiles when new evidence incorporated or when judged necessary. |
| Developing Recommendations and Determining their Strength | Developing recommendations focuses on integrating the factors that influence a recommendation using a structured analytic framework, and a transparent and systematic process. Determining the strength of the recommendations refers to judgments about how confident a guideline panel is that the implementation of a recommendation exerts more desirable than undesirable consequences. | No Evidence-to-Decision (EtD) tables were developed for the ACR RA guideline | The coordination team developed an EtD table for each question. The panel used the GRADE evidence profiles and EtD tables at the time of the meeting and decided on the direction and strength of the final recommendations. |
| Wording of Recommendations and of Considerations of Implementation, Feasibility and Equity | Wording of recommendations refers to choosing syntax and formulations that facilitate understanding and implementation of the recommendations. Such wording is connected to considerations of implementation, feasibility and equity, which refer to the guideline panel’s considerations about how the recommendation will be used and what impact it, may have on the factors described. | The panelists reviewed and refined the wording of the final recommendation. | |
| Reporting and Peer Review | Reporting refers to how a guideline will be made public (e.g. print, online). Peer review refers to how the guidelines document will be reviewed and how it can be assessed (e.g. for errors), both internally and externally, prior to its publication by stakeholders who were not members of the guideline development group. | Pending | |
| Dissemination and Implementation | Dissemination and implementation focuses on strategies to make relevant groups aware of the guidelines and to enhance their uptake (e.g. publications and tools such as mobile applications). | Pending | |
| Evaluation and Use | Evaluation and use refers to formal and informal strategies that allow judgments about: evaluation of the guidelines as a process and product; evaluation of the use and/or uptake; and evaluation of impact and whether or not the guideline leads to improvement in patient or population health or other consequences. | Pending | |
| Updating | Updating refers to how and when a guideline requires revision because of changes in the evidence or other actors that influence recommendations. | Pending | |