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Appendices

Appendix B. Important Guideline Considerations

NIH-CDC-HIVMA/IDSA-PIDS-AAP Guidelines for the Prevention and Treatment of Opportunistic Infections in Children with and Exposed to HIV
TopicComment
Goal of the GuidelinesProvide guidance to HIV care practitioners on the prevention and management of HIV-related opportunistic infections children with and exposed to HIV in the United States.
Panel MembersThe Panel on Opportunistic Infections in Children with and Exposed to HIV (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 55 members with expertise in HIV clinical care, infectious disease management, and research in children. The Panel members are selected from government, academia, and the health care community by the Executive Secretary and co-chairs and assigned to a working group for one or more of the guidelines’ 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 4-year term, with an option to be reappointed for additional terms. The list of the current working group members can be found in Appendix C.
Financial Disclosure and Management of Conflicts of InterestAll members of the Panel submit an annual written financial disclosure 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 D. 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 guidelines 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 is awarded to a working group member’s university or institution (e.g., grants, research funding) are not considered a conflict of interest.
Users of the GuidelinesPediatric HIV treatment providers in the United States
DeveloperPanel on Opportunistic Infections in Children with and Exposed to HIV—a working group of the NIH Office of AIDS Research (OAR) Advisory Council
Funding SourceOAR, NIH
Other GuidelinesThese guidelines focus on prevention and treatment of HIV-related opportunistic infections for children with or exposed to HIV, including prepubertal adolescents, in the United States. A separate set of guidelines outlines similar recommendations for post-pubertal adolescents and adults. These guidelines are also available on the Clinicalinfo website.
Update PlanEach working group lead (chair) 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, including emerging infectious diseases. Updates that may significantly affect patient safety or treatment and that warrant rapid notification may be posted temporarily on the Clinicalinfo website until the guidelines document can be updated.
Public CommentsAfter release of an update on the Clinicalinfo 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 working group and the co-editors as to whether revisions are indicated. The public may also submit comments to the Panel at any time at HIVinfo@NIH.gov.

 

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