Abstract
Introduction: Professional societies, like many other organizations around the world, have recognized the need to use rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the twelfth of a series of 14 articles that were prepared to advise guideline developers in respiratory and other diseases. This article discusses the reporting and publishing of guidelines.
Methods: The authors formulated and discussed the following questions on the reporting and publishing of guidelines. (1) What should be reported in guidelines? (2) How should guidelines be written? (3) How should the bottom-line message be conveyed? (4) How should guidelines be packaged? (5) Where should guidelines be published? (6) Who benefits from the publication of guidelines? (7) What information should be vetted by the editor(s)? (8) How should guidelines be peer reviewed? We conducted a review of the literature, looking for systematic reviews and methodological research that addressed these questions, but we did not conduct a full systematic review. Our conclusions are based on the available evidence from the published literature and logical arguments from experienced guideline developers.
Results and Discussion: There is little empirical evidence that addresses the reporting and publishing of guidelines. A standard format for reporting guidelines is desirable to ensure that guidelines are comprehensive and that all of the information necessary to judge their quality is presented. In addition, guidelines should contain concise evidence-based recommendations. To facilitate the use of guidelines by consumers, it is preferable to publish them in journals that serve the target audience and to package them in multiple ways. Editors and peer reviewers should ensure that reporting standards have been met, potential conflicts of interest have been adequately addressed and made public, and that the recommendations address important clinical questions.
Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. In June 2007 the American Thoracic Society (ATS) and the European Respiratory Society (ERS) convened an international workshop of methodologists and researchers from around the world to coordinate efforts in guideline development, using chronic obstructive pulmonary disease (COPD) as a model (1).
This is the twelfth of a series of 14 articles that were prepared to advise those who develop guidelines related to respiratory and other diseases. The focus of this article is the reporting and publishing of guidelines, which are essential steps in the dissemination of recommendations to the health care community.
The authors formulated and discussed the questions shown in Table 1. We did not conduct a full systematic review of the literature according to standard methodology. To find evidence relevant to the questions, we searched PubMed, the Cochrane Methodology Register (2), and the National Guideline Clearinghouse (3) for systematic reviews and methodological research.
| Reporting guidelines |
| 1. What should be reported in guidelines? |
| 2. How should guidelines be written? |
| 3. How should the bottom-line message be conveyed? |
| 4. How should guidelines be packaged? |
| Publishing guidelines |
| 5. Where should guidelines be published? |
| 6. Who benefits from the publication of guidelines? |
| 7. What information should be vetted by the editor(s)? |
| 8. How should guidelines be peer reviewed? |
For PubMed, we used the MeSH database with the following search terms: “Publishing [MH] AND Guideline [TIAB],” “Peer Review, Research [MH] AND Guideline [TIAB],” “Reporting [TW] AND Guideline [TIAB],” “Format [TW] AND Guideline [TIAB],” “Standards [TW] AND Guideline [TIAB],” and “Documentation [TW] AND Guideline [TIAB].” The Cochrane Methodology Register was searched by combining the abstract words format, reporting, or publishing with the key words, “CMR: applicability and recommendations—recommendations” or “CMR: applicability and recommendations—levels of evidence and strength of recommendations.” The National Guideline Clearinghouse was searched using the annotated bibliography. Search terms included reported, publishing, format, structure, standards, and documentations. Finally, related articles and the reference list from retrieved articles were also reviewed. The literature search has been updated periodically since the workshop and is current through May of 2011.
Our conclusions are based on evidence from the published literature, workshop discussion, logical arguments, and consensus from experienced guideline developers and editors who participated in the writing of this article.
Database searches did not yield any systematic reviews related to the reporting or publishing of guidelines. Several observational studies, conference proceedings, and a prior review on this topic were identified (4). The important findings are described below.
During the Conference on Guideline Standardization (COGS), representatives from 22 organizations with expertise in developing and publishing clinical practice guidelines used a two-stage modified Delphi process to generate reporting standards for clinical practice guidelines (5). The checklist shown in Table 2 lists the 18 topics that participants in the COGS believed should be routinely reported in clinical practice guidelines. Although several organizations use these reporting standards (5), other organizations and journals have developed their own reporting standards (6) or follow the National Guideline Clearinghouse’s Template of Guideline Attributes (3).
| Topic | Description |
| 1. Overview | Structure the abstract to include the guideline’s release date, status (original, revised, updated), and print and electronic sources |
| 2. Focus | Describe the primary disease and intervention that the guideline addresses, as well as alternative interventions that were considered |
| 3. Goal | Describe the rationale for developing the guideline and the goal that following the guideline is expected to achieve |
| 4. Users | Describe the intended users of the guideline (e.g., type of clinician, patients) and the settings in which use of the guideline is intended |
| 5. Population | Describe the patient population to which recommendations may be applied, as well as exclusion criteria |
| 6. Developer | Identify the organizations responsible for the guideline’s development, as well as the names, credentials, and potential conflicts of interest of the participants |
| 7. Funding | Identify the funding source and its role in developing or reporting the guideline, including potential conflicts of interest |
| 8. Evidence | Describe the methods used to search the scientific literature, including the range of dates, databases searched, and criteria used to filter the retrieved evidence |
| 9. Grading | Describe the criteria used to rate the quality of the evidence that supports the recommendations and the system for describing the strength of the recommendation |
| 10. Synthesis | Describe how the evidence was used to develop recommendations (e.g., meta-analysis, evidence tables) |
| 11. Review | Describe how the guideline developer reviewed and tested the guideline before its release |
| 12. Update | Indicate whether the guideline will be updated and if there is an expiration date for the current version |
| 13. Definitions | Define terms that may be unfamiliar or subject to misinterpretation |
| 14. Recommendations | State recommendations precisely and support each with evidence. Indicate the strength of the recommendation and the quality of the evidence |
| 15. Benefits/harms | Describe the anticipated benefits and potential harms associated with implementation of the guideline recommendations |
| 16. Preferences | Describe the role of patient preferences when the recommendation involves substantial personal choice |
| 17. Algorithm | Illustrate the steps in clinical care described by the guideline, if appropriate |
| 18. Implementation | Describe potential barriers to the application of the recommendations |
We believe it is desirable to have a standard format for reporting guidelines that all organizations that develop guidelines accept. This will ensure that guidelines are comprehensive and that all of the information necessary to judge their quality is presented. Such a format can be generated from existing reporting standards, as well as instruments that are used to evaluate clinical practice guidelines (7–11).
The standard format would ideally require that the following be reported: rationale for the guideline, target audience, scope (patient population, interventions and outcomes considered), methodology (questions asked, literature searches, evidence selection and analysis, formulation and grading of recommendations), recommendations (including clear specification of the population to whom the recommendation applies and the alternatives considered), evidence supporting the recommendations, algorithm(s), references, completion date, guideline committee, authors, conflict of interest disclosures (including how they were reviewed and how conflicts were resolved), funding sources, and sponsoring organizations. With respect to the recommendations, we support the approach advocated by the Institute of Medicine (IOM, Washington, DC), which involves describing and explaining differences of opinion regarding the recommendations, or reporting the results of voting, because it maximizes transparency (11). Although some guideline developers may choose not to include content for every item, they should explicitly address whether the item was considered by the guideline development team (6).
Standardized reporting will also permit assessment of the quality of guidelines with appraisal tools such as the AGREE (Appraisal of Guidelines, Research and Evaluation) II tool (9).
For guidelines to be helpful to clinicians at the point of care, they need to be concise so that information can be located easily and quickly. Excessive time spent trying to find information is a deterrent to seeking the answer to a clinical question (12). The duration judged excessive by most clinicians is uncertain, but is probably quite short. In one observational study, the median time spent pursuing the answer to a clinical question was less than 2 minutes (13).
Guidelines also need to be comprehensive because most are used by a variety of stakeholders (14). Organization of guidelines into many sections, each with a descriptive header and predictable writing style (i.e., the most important information is consistently stated at the beginning or end of a section), is an approach that allows guidelines to be both comprehensive and concise. The descriptive headers make it easier for readers to locate the section that contains the answer to their clinical question, and a predictable writing style makes it easier to locate pertinent information within each section.
Presenting information in the same sequence as a typical patient encounter (e.g., diagnosis before treatment) improves clinician understanding (15). Lists, tables, bolded subheadings, and algorithms are preferred over lengthy uninterrupted prose (16).
For each subject addressed in a clinical practice guideline, it is desirable to convey the bottom-line message in the form of one or more recommendations. Although there are no consensus standards for how recommendations should be formulated (6), an optimal recommendation indicates the population for which the recommendation is intended, the intervention that is being recommended, and the alternative approach or intervention (17). As an example, a reasonable recommendation may state, “We recommend that all patients with COPD use a short-acting β-agonist on an as-needed basis, rather than on a regularly scheduled basis.”
Most organizations that develop guidelines grade the quality of the evidence and the strength of the recommendations. Many groups have adopted the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system of grading recommendations (6, 18–20). The formulation and grading of recommendations using the GRADE system are discussed in separate articles within this series (17, 18).
Most clinical practice guidelines are reported as full guidelines, which include references and notes (6, 21). Many are also distributed as an executive summary, a summary of recommendations, separate versions for different users, and/or application tools (e.g., algorithms) (6).
We support the packaging of guidelines in multiple ways because this facilitates their use by different consumers. Busy clinicians likely rely on summaries and application tools at the point of care, whereas organizations are more likely to benefit from the more comprehensive full guidelines. When summary versions are reported, the recommendations should contain sufficient information that they can be understood without reference to other supporting material (22).
Evidence summaries, such as full evidence profiles or summary of findings tables (4, 23), should accompany the guideline. Such summaries improve the understanding of the evidence and shorten the duration needed to retrieve pertinent information from systematic reviews (24). The evidence summaries should be transparently linked to the related recommendation, thereby facilitating understanding and judgments about whether the evidence applies to the health care situation. Extensive web repositories of the evidence that influences recommendations are a feasible and attractive option for complete reporting.
Clinical practice guidelines developed by national organizations should be written and packaged in a way that allows them to be modified for local use. As an example, recommending a class of medications (e.g., long-acting β-agonist) in a guideline allows a local institution to apply the recommendation, using a medication that exists in its formulary (e.g., salmeterol or formoterol).
Electronic publication facilitates the packaging of guidelines in multiple formats. An electronically published guideline can provide hyperlinks that quickly direct readers to an executive summary, a summary of recommendations, application tools, alternative versions, or other derivates. Each of these formats can similarly provide hyperlinks that direct readers to the primary version of the guideline or other derivatives, thereby creating a web of hyperlinked versions of the guideline. For printed guidelines, it may be helpful to provide a section that lists the universal resource locators (URLs, or web addresses) of the electronic version of the guideline and its derivatives.
Clinical practice guidelines that are effectively disseminated and implemented can significantly impact clinical practice (25, 26). In contrast, guidelines will have only a small influence on clinical practice if they are published without a strategy to promote implementation, even if they are published in a prominent medical journal, address an important topic, are of high quality, and are frequently cited (25, 27). A separate article within this series addresses guideline dissemination and implementation (28).
Despite the lack of evidence that publication site matters, we believe that it is desirable to publish a guideline in a medical journal that serves a guideline’s target audience. The journal that publishes the guideline is often supported by the same organization that funded the development of the guideline. When guideline development is funded by two or more organizations, the target journal should be determined in advance and documented in a memorandum of understanding between the organizations.
A guideline may occasionally target a heterogeneous audience that is served by different journals. As an example, a guideline about pneumonia may target the pulmonary and infectious disease communities, which tend to read different journals. In such cases, maximizing visibility of the guideline may warrant duplicate publication in different journals, but this needs to be agreed on by the editors of the journals and/or the sponsoring organizations. Duplicate publication is the exception rather than the norm because it can be expensive, difficult to coordinate publication and updating, and may involve copyright issues (29). However, it facilitates dissemination. When an agreement is reached to allow duplicate publication, some organizations choose to publish only the executive summary to decrease cost. Publication in journals that are translated into multiple languages is another way to improve the visibility of a guideline (30).
Medical journals frequently have different policies regarding electronic open access. In particular, the duration before an article can be accessed electronically without cost to the reader varies among journals. Many funding agencies require that any work that they support be submitted to journals with open access policies that are acceptable to the funding agency. As an example, the Medical Research Council of the United Kingdom requires that any work they support be published in journals that provide open access within 6 months of original publication (31). Such policies may affect dissemination of a guideline and should be considered carefully when the funding source and target journal are chosen.
Publication of clinical practice guidelines benefits many individuals and organizations. Journals that publish guidelines benefit because, like review articles, guidelines tend to be frequently cited and will improve a journal’s impact factor (32). The impact factor is a measure of the frequency with which a particular medical or scientific journal is referenced; it has become a measure of the importance of a journal. Although data are lacking, it is reasonable to expect that a higher impact factor may improve a journal’s prestige and the quality of its submissions. This may increase readership, subscriptions, and the profits of the professional society or organization that owns the journal.
Journal editors may also benefit from the publication of guidelines because they may receive credit for improving the journal’s standing within the medical community. In addition, authors generally receive academic credit and patients may receive better medical care (25).
There is little evidence regarding the role of journal editors in the publication of clinical practice guidelines. However, the panel drew several conclusions based on logical arguments.
Guideline development frequently depends on industry funding, committee members often have financial relationships with industry, and journals usually sell reprints of guidelines to commercial entities. These arrangements are potential financial conflicts of interest. Conflicts of interest may also be intellectual. An intellectual conflict of interest exists when committee members are involved in activities that create a vested interest in a particular viewpoint that is so strongly held that it affects their ability to consider alternative beliefs. Intellectual conflicts of interest are more difficult to identify than financial conflicts. Publicly stated viewpoints, authorship in key trials, and peer-reviewed grant funding are features of a committee member’s profile that may prompt additional scrutiny for potential intellectual conflicts of interest (33). Both financial and intellectual conflicts have the potential to introduce bias into the development of recommendations that readers expect to be impartial and evidence-based.
Potential conflicts of interest should be identified and addressed before guideline development commences. An oversight committee may be helpful in facilitating this process (34). Strategies that have been used to minimize the impact of competing interests include insisting that industry funding be in the form of an unrestricted grant with the commercial entity having no input into the process, limiting participants with significant conflicts of interest, excluding participants with significant conflicts of interest, and/or having a methodologist without important conflicts bear the primary responsibility for the final presentation of the evidence. It is important to have transparent disclosure, but disclosure alone is not enough to avoid bias.
The editor(s) of a journal have the unique opportunity and duty to review both the final guideline and the disclosures of the participants. They and the peer reviewers are often the final judges of whether a guideline contains real or perceived conflicts of interest. The editor(s) may be the final arbitrator when disagreement arises and should have the authority to require modification as a condition for publication. A separate article in this series addresses guideline funding and conflicts of interest (35).
The editor(s) must also determine whether the guideline complies with the journal’s reporting standards. Such standards ensure comprehensive reporting and that all of the information necessary to judge the quality of a guideline is included. Reporting standards for guidelines are discussed in a previous section (What Should Be Reported in Guidelines).
The IOM has released standards for developing clinical practice guidelines, which include peer review (11). The standards state that peer reviewers should comprise a full spectrum of relevant stakeholders (e.g., scientific and clinical experts, organizations, patients, and the public) and that a draft of the guideline should be made available to the general public for comment at the peer review stage or immediately after it. In addition, peer reviewers’ comments should be kept confidential and a record should be kept of the rationale for modifying or not modifying the guideline in response to each comment.
Adherence with the IOM standards occurs to various degrees among organizations that develop guidelines. The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (Bethesda, MD) employs a two-step peer review process (36). Clinical practice guidelines are initially reviewed by individuals with expertise similar to that of the guideline panel, typically researchers and methodologists. Intended users are also included in this first round of peer review. The purpose of this step of peer review is to review the draft for accuracy, practicality, clarity, organization, and usefulness of the recommendations. The draft is then modified and subjected to the second step of peer review. The revised draft is posted on the NHLBI website and a call is issued for public review and comment. Comments can be posted on the NHLBI website or made during a public forum that is conducted by the guideline committee.
The National Institute for Health and Clinical Excellence (NICE, London, UK) also uses a multistep peer review process (37, 38). Guidelines are constructed by the Guideline Development Group of NICE, which includes a variety of stakeholders (e.g., physicians, nurses, ancillary personnel, patients). The Consensus Reference Group of NICE then votes on the resulting recommendations. Once the recommendations are agreed on, the guideline is posted on the NICE website and sent to a variety of stakeholders for peer review, including professional organizations. Comments are then discussed by the Guideline Development Group and the guideline is modified. The revised guideline may be finalized or may be subjected to another round of peer review. An independent Guideline Review Panel validates the final full guideline after checking to make sure that stakeholder comments have been taken into account.
The ATS, ERS, American College of Chest Physicians, Infectious Diseases Society of America, and possibly other organizations, have guideline editors and committees that facilitate peer review and help with adherence to methodological criteria in guideline development.
The strength of these approaches is that all stakeholders have the opportunity to comment on the quality of a guideline. Potential pitfalls are that some journals do not routinely perform peer review when a guideline is submitted because the peer review has already occurred as part of a separate document development process, and the multiple steps may delay the release, dissemination, and implementation of the guideline while seemingly minor disagreements are resolved. In addition, the accessibility of the document during the later stages of the peer review process makes it possible for the guideline to be applied to clinical practice before it is finalized and may conflict with a journal’s embargo policy. This conflict may influence the journal that is selected to publish a guideline, cause a journal to make an exception to its embargo policy and lose revenue, or lead a guideline to not adhere to the IOM’s standards and forego public comment to adhere to the embargo policy.
There is limited empirical evidence about the reporting and publishing of clinical practice guidelines. As a result, many of our conclusions are based on logical arguments from experienced guideline developers.
A standard format for reporting guidelines is desirable to ensure that guidelines are comprehensive and that all of the information necessary to judge their quality is presented. In addition, guidelines should contain succinct evidence-based recommendations. We support packaging guidelines in multiple ways to facilitate their use by various consumers, whenever resources permit. This includes full guidelines, an executive summary, summary of recommendations, separate versions for different users, and/or application tools, such as algorithms.
It is preferable to publish a guideline in a journal that maximizes its visibility to the target audience. Editor(s) and peer reviewers should rigorously vet guidelines to ensure that reporting standards have been met and potential conflicts of interest have been adequately addressed. It is appropriate to involve methodologists, researchers, clinicians, and other stakeholders in the peer review of guidelines.
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This article is a section of “Integrating and Coordinating Efforts in Chronic Obstructive Pulmonary Disease (COPD) Guideline Development,” an American Thoracic Society (ATS) and European Respiratory Society (ERS) Workshop Report. This official ATS/ERS Workshop Report was adopted by the ATS Board of Directors, August 2012, and by the ERS Executive Committee, February 2012.
Funding for this conference was made possible (in part) by 1R13HL 90485–01 from the National Institutes of Health. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.
Author disclosures: K.C.W. was employed by UpToDate, Inc. R.S.I. reported no commercial interests relevant to subject matter. T.M.F. was on advisory committees and received lecture fees from Bayer, GlaxoSmithKline, Merck, Ortho\x{2010}McNeil, Pfizer, Sanofi-Aventis, Schering and Wyeth. He received grants from Bayer, Binax, Ortho\x{2010}McNeil, Oscient, Pfizer, Sanofi-Aventis and Wyeth. H.J.S. was a member of the GRADE Working Group, which received honoraria and lecture fees regarding GRADE. G.H.G. was a member of the GRADE Working Group. K.F.R. reported no commercial interests relevant to subject matter. All workshop participants disclosed receipt of honoraria and travel reimbursement from the American Thoracic Society.