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Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children

Appendices

Appendix 1. Important Guideline Considerations

(Last updated: November 6, 2013; last reviewed: November 6, 2013)

NIH-CDC-HIVMA/IDSA-PIDS-AAP Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children
Topic Comment
Goal of the Guidelines Provide guidance to HIV care practitioners on the prevention and management of HIV-related opportunistic infections for HIV-exposed and HIV-infected children in the United States.
Panel Members
The panel is composed of the Executive Secretary and two non-governmental Co-Chairs with expertise in pediatric HIV infection and infectious diseases. The panel has members who represent the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the HIV Medical Association of the Infectious Disease Society of America (HIVMA/IDSA), the Pediatric Infectious Disease Society (PIDS), the American Academy of Pediatrics (AAP), plus approximately 30 members with expertise in HIV clinical care, infectious disease management, and research in children. The panel members are selected from government, academia, and the healthcare community by the Executive Secretary and Co-Chairs and assigned to a working group for one or more of the guideline’s sections based on the member’s area of subject matter expertise. Each working group is chaired by a panel member selected by the co-chairs. Members serve on the panel for a four-year term, with an option to be reappointed for additional terms. The list of the current working group members can be found in Appendix 2.
Financial Disclosure and Management of Conflicts of Interest 
All members of the panel submit a written financial disclosure annually reporting any associations with manufacturers of drugs, vaccines, medical devices, or diagnostics used to manage HIV-related opportunistic infections. A list of these disclosures and the date of their last update are available in Appendix 3. The panel co-editors review each reported association for potential conflict of interest and determine the appropriate action: disqualification from the panel, disqualification/recusal from topic review and discussion, or no disqualification needed. A conflict of interest is defined as any direct financial interest related to a product addressed in the section of the guideline to which a panel member contributes content. Financial interests include direct receipt by the panel member of payments, gratuities, consultancies, honoraria, employment, grants, support for travel or accommodation, or gifts from an entity having a commercial interest in that product. Financial interest also includes direct compensation for membership on an advisory board, data safety monitoring board, or speakers’ bureau. Compensation and support that filters through a working group member’s university or institution (e.g., grants, research funding) is not considered a conflict of interest. 
Users of the Guidelines
Pediatric HIV treatment providers in the United States
Developer
Panel on Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children—a working group of the Office of AIDS Research (OAR) Advisory Council
Funding Source
OAR, NIH
Evidence Collection
The recommendations in the guidelines are generally based on studies published in peer-reviewed journals. On some occasions, particularly when new information may affect patient safety, unpublished data presented at major conferences or information prepared by the U.S. Food and Drug Administration or manufacturers (e.g., warnings to the public) may be used as evidence to revise the guidelines. Panel members of each working group are responsible for conducting a systematic comprehensive review of the literature, for conducting updates of that review, and for bringing to their working group’s attention all relevant literature and documents that merit evaluation based on the quality and content of data.
Method of Synthesizing Data and Formulating Recommendations
Each section of the guidelines is assigned to a panel member with expertise in the area of interest. The panel member synthesizes the available evidence. Recommendations are reviewed and updated by each working group after an assessment of the quality and impact of the existing and any new data. Aspects of evidence that are considered include, but are not necessarily limited to, the type of study (e.g., case series, prospective cohort, randomized controlled trial), the quality and appropriateness of the methods, the number of subjects and effect sizes observed, and data from both adult and pediatric studies. Finally, all material is reviewed by the Executive Secretary, Co-Chairs, by the OAR, by subject matter experts at the CDC, the HIVMA/IDSA, the PIDS, and AAP prior to final approval and publication. In general, these recommendations were developed based on combining scientific evidence with expert opinion. Randomized clinical trials in children remain the gold standard; however, because studies focusing on HIV-infected children in relation to each pathogen are uncommon, all studies including observational studies, were considered. When there were no pediatric studies available, recommendations were based on adult studies. Finally, when there was lack of published literature altogether, recommendations were based on expert opinion. Summary tables of evidence for these guidelines were not developed because of the small number of studies available for each question in consideration. 
Recommendation Rating
Recommendations are rated using a revised version of the previous rating system (see Table in Introduction: Rating System for Prevention and Treatment Recommendations) and accompanied, as needed, by explanatory text that reviews the evidence and the working group’s assessment. All proposals are discussed at teleconferences and by email and then assessed by the panel’s Executive Secretary and Co-Chairs and reviewed by the OAR, the CDC, the HIVMA/IDSA, the PIDS, and the AAP before being endorsed as official recommendations.
Other Guidelines
These guidelines focus on prevention and treatment of HIV-related opportunistic infections for HIV-exposed and HIV-infected children in the United States. A separate guideline outlines similar recommendations for adults. These guidelines are also available on the AIDSinfo website (http://www.aidsinfo.nih.gov). 
Update Plan
Each work group and the co-editors meet at least every 6 months by teleconference to review data that may warrant modification of the guidelines. Updates may be prompted by approvals of new drugs, vaccines, medical devices or diagnostics; by new information regarding indications or dosing; by new safety or efficacy data; or by other information that may affect prevention and treatment of HIV-related opportunistic infections. Updates that may significantly affect patient safety or treatment and that warrant rapid notification may be posted temporarily on the AIDSinfo website (http://www.aidsinfo.nih.gov) until the guideline document can be updated.
Public Comments
After release of an update on the AIDSinfo website, the public is given a 2-week period to submit comments to the panel. These comments are reviewed, and a determination is made by the appropriate work group and the co-editors as to whether revisions are indicated. The public may also submit comments to the Panel at any time at contactus@aidsinfo.nih.gov.

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