The CDC Guideline Development and Reporting Checklist (GDRC) will help you develop guidelines that comply with well-known standards used by most recognized guideline authorities in the world. The World Health Organization (WHO) defines a guideline as: "A guideline is a document that contains recommendations about health interventions, whether they be clinical, public health, or policy interventions. A recommendation provides information about what policy makers, health care providers, or patients should do. It implies a choice between different interventions that have an impact on health and that have ramifications for the use of resources." 1 CDC's guidelines and recommendations vary in content, scope, audience, and development methods. The style will also vary depending on how the document is distributed and accessed. Venues for CDC guidelines include Morbidity and Mortality Weekly Report (and Recommendations and Reports), peerreviewed journals, and CDC-branded and partner publications. CDC's Office of the Associate Director for Science (OADS) recognizes that one reporting template for all CDC guidelines is neither practical nor sufficient. Yet by identifying key elements that each report should contain, we enhance transparency, clarity, and credibility. These key elements are indicated in the checklist that follows. The elements were adapted from the CDC Primer, developed by the CDC Guidelines and Recommendations Work Group in 2012. 2 CDC-OADS clearance officials also use the checklist when reviewing and clearing guidelines and recommendations. Each element includes an example from a published guideline, followed by a text box titled "Type description here." This allows guideline developers to use the checklist as a working document. Guideline developers should determine the appropriate process for developing the guidelines, such as creating an internal working group or involving subject matter experts outside CDC to develop material or to review and approve the guideline. This may be done ad hoc by creating a larger working group and steering committee or by using a committee already chartered under the Federal Advisory Committee Act (FACA). Guideline developers should first determine whether their proposed guidelines is subject to the Federal Advisory Committee Act (FACA). To find out if FACA applies, contact the MASO Federal Advisory Committee Policy and Oversight Team (CDC) at facmp&o@cdc.gov or by calling (770) 488-4707. Regardless of whether FACA rules apply, guideline developers should follow this checklist to improve the quality of the guidelines and to ensure CDC OADS clearance is obtained. When reporting guidelines, the style you select will depend on the audience, publication venue, and intended use. Guideline developers must use their best judgment in deciding how to report key You may contact the Guidelines and Recommendation Activity Team located in the OADS, Office of Science Quality for a consultation at any stage of the guideline development process. For more information about the Guidelines and Recommendations Activity, resources and tools, and training, visit the Office of the Associate Director for Science Guidelines and Recommendations Activity site.#
information. Some information will require detailed description, and presentation format may vary. For example, detailed technical material may be put in appendices. A short-version document may be used to report the recommendations and summarize the methods used, whereas a longer, technical document may be used to report detailed descriptions of searches and evidence tables. Short versions need to provide enough detail so that readers can understand the rationale behind the development process and can locate supplemental information reported in electronic or printed documents.   --------------------------------------- Type description here.
10.  Describe questions related to guideline topic for systematic literature review. 11.  Describe the literature search protocol; cover at least 10 years of most recent published literature and databases used.

# Example of questions related to guideline topic for systematic literature review

# Example of search criteria and sources:
"The scientific literature was searched through December 2000 by using the MEDLINE database of the National Library of Medicine (started in 1966), the Educational Resources Information Center database (ERIC, 1966), the Cumulative Index to Nursing and Allied Health database (CINAHL, 1982), andHealthstar (1975). The medical subject headings (MeSH) searched were diabetes, case management, and disease management, including all subheadings. Text word searches were performed on multiple additional terms, including care model, shared care, primary health care, medical specialties, primary, or specialist. Abstracts were not included because they generally had insufficient information to assess the validity of the study using Community Guide criteria. A total of 22 dissertations were excluded either because the abstracts contained insufficient information for evaluation or the full text was unavailable. Extracted articles and abstracts were reviewed for relevance; and if deemed relevant, the full-text article was retrieved. We also reviewed the reference lists of included articles, and our consultants provided additional relevant citations." Type description here.
12.  Provide criteria used to select studies extracted from the literature review.

# Example of criteria of select studies
- English language - Peer-reviewed, full-length publication with original data - Multiple publications of the same study were treated as a single study to avoid double-counting patients 
The study included at least one of the following bloodborne pathogens: HIV, HBV, and HCV.
The presence or absence of HIV/HBV/HCV was based on laboratory test(s), not on subjective estimates, physician interviews, or patient interviews.
- Additional criteria were applied on a per-question basis, as depicted in Table 1 on the next page. For many questions, an insufficient number of studies were identified to support the development of the guideline. Consequently, in an effort to provide a sufficient amount of relevant information to support the development of the guideline, committee members expanded the inclusion criteria in multiple iterations over several months." 13.  Provide a table of findings that summarizes the body of evidence or a link to websites containing evidence tables. 14.  Describe methods used to assess evidence quality, whether they be GRADE, Cochrane, USPSTF, Community Guide, or other methods.

# (Continued on the next page)

# Example of summary of findings table:

# Example of description of methods used to assess evidence quality:
"We used the GRADE evidence rating methodology, which has been developed for treatment comparisons (Questions 6, 7 and 8) 1 6.3. The details of the application of the GRADE system for each question are described in those sections. GRADE methodology has not been developed for the questions on epidemiology (Question 1), transmission (Question 2), risk factors (Questions 3 and 4), and the impact of exclusions on the donor pool (Questions 9 and 10). For these, we created GRADE methodology as follows.
For Questions 1 and 2, no randomized trials are necessary to address the questions, therefore the starting evidence grade was high and we applied the other components of the GRADE system as appropriate. For Questions 3 and 4, we used a starting evidence grade of Low because risk factor studies are by nature observational. Portions of Questions 3 and 4 involve the prevalence of risk factors; these were graded similarly as Question 1 (epidemiology). For Questions 9 and 10, it was not necessary to develop new GRADE methodology, because for Question 9 there was only one study and it had already been graded in Question 8, and for Question 10 there were no included studies." Type description here.
16.  Describe methods used to obtain and assess economic data.

# Example of methods to obtain and assess economic data:
To examine the cost-effectiveness of various strategies for assessing HCP protection from hepatitis B, two economic models that yielded calculations of the incremental cost per quality-adjusted life-year (QALY) saved were developed. One model represented an approach in which anti-HBs is measured on a preexposure basis, and HCP with anti-HBs <10 mIU/mL receive an additional dose of HepB vaccine, followed by repeat anti-HBs measurement. If anti-HBs remains <10 mIU/mL after the first revaccination dose, the HCP receives two additional revaccination doses of HepB vaccine followed by repeat anti-HBs measurement. Another model represented a postexposure management approach; at the time of exposure, the HCP is tested for anti-HBs and the source patient is tested simultaneously for HBsAg, and postexposure prophylaxis would be administered on the basis of these results. Results from the two models were compared. A decision-tree analysis was used to combine all parameters and calculate the total intervention costs and probability of infection. In addition, HBV infection-related costs and QALY loss (accounting for acute and asymptomatic infections and a 6% probability of chronic infection) were determined from an existing model ( 89 17.  Summarize the evidence of economic efficiency for proposed recommendations.

# Example of narrative of economic efficiency:
"For pre-exposure anti-HBs testing followed by revaccination and retesting, if necessary, compared with doing nothing, the incremental cost per QALY saved was $4,542,467 for trainees and $3,149,183 for nontrainees at year one,and decreased to $893,619 and $796,140, respectively, over 10 years. This approach is expected to result in 3.7 and 1.6 visits to occupational health for trainees and nontrainees, respectively. The expected number of infections is 0.7 per 100,000 and 0.4 per 100,000 for trainees and nontrainees, respectively. For an approach relying upon postexposure management, compared with doing nothing, the incremental cost per QALY saved was $2,270,801 for trainees and $1,610,998 for nontrainees at year one, and decreased to $917,859 and $1,114,364 respectively, over 10 years. The expected number of infections is 3.0 per 100,000 and 1.7 per 100,000 for trainees and nontrainees, respectively. Although an approach relying upon postexposure management might be less costly per QALY saved initially for many institutions, pre-exposure anti-HBs testing with possible revaccination becomes more cost-effective compared with a postexposure approach over time. Sensitivity analyses demonstrated that costeffectiveness improves in settings where a greater proportion of source patients are HBsAg-positive and among HCP with higher risk for exposure (e.g., surgeons Example of linking the recommendation to the evidence:
Recommendations:
- Amenorrhea does not require any medical treatment. Provide reassurance. If a woman's regular bleeding pattern changes abruptly to amenorrhea, consider ruling out pregnancy if clinically indicated. - If amenorrhea persists and the woman finds it unacceptable, counsel her on alternative contraceptive Evidence Summary:
During contraceptive counseling and before insertion of the implant, information about common side effects such as unscheduled spotting or light bleeding and amenorrhea, especially during the first year of use, should be discussed. A pooled analysis of data from 11 clinical trials indicate that a significant proportion of etonogestrel implant users had relatively little bleeding: 22% of women experienced amenorrhea and 34% experienced infrequent spotting, although 7% reported frequent bleeding and 18% reported prolonged bleeding (121). Unscheduled bleeding or amenorrhea is generally not harmful. Enhanced counseling about expected bleeding patterns and reassurance that bleeding irregularities are generally not harmful has been shown to reduce discontinuation in clinical trials with other hormonal contraceptives (i.e., DMPA) (101,102). A systematic review and four newly published studies examined several medications for the treatment of bleeding irregularities with primarily LNG contraceptive implants (122)(123)(124)(125)(126). Two small studies found significant cessation of bleeding within 7 days of start of treatment among women taking oral celecoxib (200 mg) daily for 5 days or oral mefenamic acid (500 mg) 3 times daily for 5 days compared with placebo (124,125). Differences in bleeding cessation were not found among women with etonogestrel implants taking mifepristone but were found when women with the implants combined mifepristone with either ethinyl estradiol or doxycycline (126,127). Doxycycline alone or in combination with ethinyl estradiol did not improve bleeding cessation among etonogestrel implant users (126). Among LNG implant users, mifepristone reduced the number of bleeding or spotting days but only after 6 months of treatment (128). Evidence also suggests that estrogen (129)(130)(131) 19.  Describe methods used to formulate recommendations (e.g., group discussion, consensus).

# Example of methods used to formulate the recommendations:
"During October 4-7, 2011, CDC convened a meeting in Atlanta, Georgia, of 36 experts who were invited to assist in guideline development and provide their perspective on the scientific evidence presented and the discussions on potential recommendations that followed. The group included obstetrician/ gynecologists, pediatricians, family physicians, nurse-midwives, nurse practitioners, epidemiologists, and others with research and clinical practice expertise in contraceptive safety, effectiveness, and management. Participants received all of the systematic reviews before the meeting. During the meeting, the evidence from the systematic review for each topic was presented, and participants discussed the evidence and the translation of the scientific evidence into recommendations that would meet the needs of U.S. health care providers. In particular, participants discussed whether and how the U.S. context might be different from the global context and whether these differences suggested any need for modifications to the global guidance. CDC gathered the input from the experts during the meeting and finalized the recommendations in this report. The document was peer reviewed by meeting participants, who were asked to comment on specific issues that were raised during the meeting. Feedback also was received from an external review panel, composed of health care providers who had not participated in the meetings. These providers were asked to comments on the accuracy, feasibility, and clarity of the recommendations, as well as to provide other comments. Areas of research that need additional investigation also were considered during the meeting (31)." 20.  Describe factors that influenced the strength of the recommendations including how expert opinion, values, and preferences supported the recommendations.

# Examples of factors influencing the strength of the recommendations:
"To evaluate the evidence on reducing transmission of HIV, HBV, and HCV, we examined data addressing 10 key questions within five major topic areas (Figure 1). A sixth topic area includes questions addressed by expert opinion (Figure 2). We drew upon subject-matter experts to draft summaries related to these questions, as a preliminary scan of the literature showed that a systematic review would likely yield insufficient data. Recommendations related to the 10 key questions were based on a targeted systematic review of the best available evidence, with explicit links between the evidence and recommendations. To accomplish this review, we used a modified Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for evaluating quality of evidence and determining strength of recommendations.  If weighing the critical outcomes for a key question resulted in a net benefit or a net harm, then a Category I recommendation was formulated to recommend strongly for or against the given intervention, respectively. If weighing the critical outcomes for a key question resulted in a trade-off between benefits and harms, then a Category II recommendation was formulated to recommend that providers or institutions consider the intervention when deemed appropriate. In addition to a category rating, recommendations were also assigned a level rating (A through D)  21.  Describe other considerations that informed the recommendations (e.g., applicability, feasibility, barriers to implementation).

# Example of assessment of applicability of the recommendation:
"The same body of evidence used to assess effectiveness was used to assess the applicability of smoking bans and restrictions to different settings and populations. Smoking bans and restrictions were evaluated in a variety of settings, including hospitals and medical centers, 28,57,72 offices of health care providers, 57 workplaces in the government or public sector, 35,47,55 and a university. 42 Studies on representative samples of employed people in California 31,61,79,80 and in Missouri 36 demonstrated that smoking bans and restrictions reduced self-reported exposure to ETS in workplaces community-wide. Studies included representative samples of indoor workers in the states of California 31,61,79,80 and Missouri, 36 large, diverse samples of government employees in Texas, 47 and health maintenance organization (HMO) employees in Oregon. 57 The evidence of effectiveness in these studies should extend to most indoor workers in the United States." -----------------------------------------------------------------------------------

# Example of barriers to implementation of the intervention:
"A major barrier to efforts by local governments to adopt smoking bans is pre-emption, which is the passage or presence of a state law with weaker smoking restrictions that prevents implementation and enforcement of stronger local laws. 91,92

# Example of description of areas for future research
"The systematic review for this guideline revealed numerous gaps in the evidence that affected the guideline's ability to adequately address many of the key questions reviewed. Additional gaps in evidence were identified from other sources, such as comments submitted during the public comment period or in review following public comment. The following are 20 specific areas recommended for further study. These recommendations are arranged to correspond to the order of the 10 key questions followed by the three expert opinion questions; they are not listed in priority order.

# Task Force for Community Preventive Services
Community Guide Reviews-Topic Index Community Guide Reviews-Systematic Review Methods

# US Preventive Services Task Force
USPSTF Procedure Manual

# Cochrane Collaboration
Cochrane Handbook for Systematic Reviews of Interventions Cochrane Systematic Reviews

# GRADE Working Group
List of GRADE Working Group publications and presentations
Type description here.

# Review and Vetting
24.  Describe who (people and organizations) reviewed and commented on the recommendations, if the comments influenced and resulted in a revision of the recommendations.

# Example of how individuals and organizations review the recommendations
"After a draft of the tables, narrative summaries, and recommendations was completed, the guideline authors shared the draft guideline with the Expert Panel and Review Committee and made revisions to the guideline based in part on their feedback. Explain when guidelines and recommendations will be updated here.

# Additional Resources CDC Resources
CDC, Office of the Associate Director for Science. Guidelines and Recommendations: A CDC Primer, 2012.

# Conference on Guideline Standardization
Shiffman