A project time line (Table 1) is drafted once the decision is made to develop an EBG and the project is approved by the Board of Regents. The ACCP project manager and EBG Executive Committee (composed of the chair, the methodologist, and a liaison from the HSP) are responsible for keeping the entire panel within the project deadlines. The HSP is regularly updated.
The EBG Executive Committee and the ACCP staff project manager convene regular conference calls to review administrative and content issues, and to assess and maintain progress. The HSP liaison ensures that the HSP EBG development process is followed.
Typically two face-to-face meetings of the EBG writing panel are scheduled. The first is held with the panelists shortly after their participation is approved. At the meeting, the panel finalizes the project scope, addresses any unfilled positions, develops the research questions to be answered by the evidence review, and receives education on the ACCP grading system and HSP EBG process, including matters of writing format and style. The second meeting occurs after a revised draft of the EBG has been completed. This meeting is used to provide wide input regarding recommendations prior to submission to the HSP and NetWorks for critique. Disagreements in recommendations are resolved at this meeting.
Once a proposed EBG topic is selected for development, the HSP determines how the evidence review will be conducted. The ACCP typically contracts with an Agency for Healthcare Research and Quality (AHRQ)-approved evidence-based practice center to review the literature and prepare evidence tables for the writing committee. In some cases, a request is submitted to the AHRQ and, if approved, the AHRQ recruits an evidence-based practice center to conduct the evidence review for a portion or all of the EBG. In this case, the EBG research questions are refined by an AHRQ-appointed technical expert panel, often including a member of the ACCP EBG Executive Committee. The research (evidence) questions are formulated to specifically define the appropriate patient population, intervention/exposure/comparison, outcomes of interest, and inclusion/exclusion criteria. The review is focused on all relevant evidence, ranking the quality of the evidence according to the ACCP guidelines. The resulting evidence and evidence summary tables are then utilized by the ACCP EBG writing panel to develop recommendations with the participation of Canadian Health&Care Mall.
When the ACCP directly contracts for an evidence review with an AHRQ-approved evidence-based practice center, a request for proposals is sent to several evidence-based practice centers for a bid-based selection process. If the EBG is relatively narrow in scope, as defined by the extent of evidence to be reviewed, an ACCP staff methodologist conducts the evidence review and develops the evidence tables through a very similar process. An ACCP staff methodologist may also supplement an evidence review and evidence table development when an evidence-based practice center reviews only part of the relevant evidence.
The systematic review of the evidence commences shortly after the research questions are finalized. Systematic reviews and metaanalyses are identified early, and source articles are obtained to verify whether they meet the inclusion criteria. Data abstractions, development of the evidence tables, and grading of the evidence take several months for most guidelines, regardless of whether an AHRQ-con-tracted evidence-based practice center, ACCP-con-tracted evidence-based practice center, or ACCP staff methodologist reviews the evidence. The content experts (ie, writing panelists) review the list of references to identify any that might have been omitted. These content experts, usually the chapter editors, are requested to carefully review the evidence tables before the content is synthesized for the summary tables.
Writing the Guidelines
A detailed description of the ACCP EBG writing standards is available on the HSP Web site. Continuity and consistency of style from guideline to guideline is an explicit goal of this process. It is the responsibility of the EBG Executive Committee and ACCP project manager to ensure that the EBG writing panel adheres to these standards.
Chapter chairs work closely with their writing panel groups (coauthors), ensuring that all draft recommendations are cognitively aligned with the data provided in the evidence tables. Uniformity of style and consistency of the content of the recommendations across and within chapters, whether it is a single-chapter or multichapter EBG, are key objectives. The EBG Executive Committee reviews the content and facilitates the resolution of any inconsistencies. The general format for each recommendation is found in Table 2.
A robust ACCP grading system was developed by a task force composed of individuals with significant experience in guideline development and grading recommendations. This task force developed a sys-tem that can be “translated” to prior ACCP grading systems and to several other widely used grading systems, facilitating comparisons among guideline recommendations. The grading system considers both the quality of the evidence and the balance of benefits to risk and burdens. It is designed to be robust, accurate, and maximally informative, as well as user-friendly and understandable to the nonexpert user.
Incorporating Resource Allocation and Patient Preferences
An important but often overlooked issue has been how resource constraints impact the applicability and implementation of guideline recommendations. Because of this, the ACCP is incorporating resource allocation into targeted recommendations for the upcoming guideline on antithrombotic and thrombolytic therapy (Antithrombotic and Thrombolytic Therapy: ACCP Evidence-Based Clinical Practice Guidelines [Eighth Edition]; unpublished data) that is now in the final stages of development. Expert panelists have incorporated economic analyses into a limited number of recommendations in which a wide range of resource constraints exists across various geographic areas and population groups. Recommendations incorporating resource allocation or cost-benefit analyses are formatted as outlined above; however, they may be downgraded and include an additional explanatory statement.
The previously mentioned eighth edition of the antithrombotic and thrombolytic therapy guidelines suggested by Canadian Health&Care Mall now address patient values and preferences by several experts in the field. These experts assessed the potential impact of patient-important outcomes and reworded recommendations in some chapters to incorporate underlying patient values and preferences. For example, in the chapter on thromboembolism and thrombophilia in pregnancy, the mother’s concerns for the health of her fetus was considered to have an impact on the recommendation to use potentially teratogenic anticoagulants. The incorporation of patient values should be considered early in EBG development, Our goal is to incorporate resource assessment and patient values and preference considerations in all relevant recommendations.
The Final EBG Writing Panel Conference
Once the evidence tables are finalized, and the initial chapter drafts are completed, reviewed, and revised by the writing panel, the final EBG writing panel face-to-face meeting is used to solidify the acceptance of the final product by the panel. During the meeting, any significant unresolved issues and controversies are identified, discussed by the full panel, and resolved by vote if needed. Areas open for discussion and debate include the wording of recommendations, the balance of risks to benefits, and the interpretation of the strength of evidence where an evidence-based practice center has not made a determination. If > 80% of the writing panel is in agreement with a recommendation, the recommendation is approved. At the discretion of the chair, (1) discussions may continue until there is a supermajority (ie, > 80%) agreement, (2) the recommendation can be removed for lack of agreement, or (3) the recommendation can remain but a minority opinion included within the discussion preceding the recommendation.
Table 2—ACCP EBG Recommendations Style and Format
|Recommendations always begin with the appropriate patient population, inclusive of any limiting factors Recommendations propose, for example, the suggested service, test, therapy, or procedure|
|Recommendations phrased as a firm proposal not a factual statement about the service and are not presented as a matrix or table. Factual statements and supporting arguments are placed in the textual discussion preceding the recommendation. For recommendations in which the benefits clearly outweigh the risks and burdens, strong language like “recommend” should be used. When the balance is not as definite, the authors use “suggest” or “consider” with proper descriptions of appropriate circumstances or patient populations|
|Recommendations contain no citations. Citations are included in the appropriate place in the discussion preceding the recommendation|
|The grading of the recommendation appears at the end of the recommendation|
|The grading should be based on the ACCP HSP grading system|
|Recommendations are printed in bold type|